User's Manual Incubadora SCTI Line 4

INCUBATOR FOR NEWBORN
Model: SCTI LINE 4
USER GUIDE
February / 2013
Revision 02
No part of this manual may be reproduced or transmitted by any means and for any purpose without written
permission of Olidef.
This equipment had its project developed and manufactured exclusively by Olidef cz Indústria e Comércio de
Aparelhos Hospitalares Ltda.
Olidef has a policy of continuous improvement of its products and reserves the right to change technical
specifications without previous notice.
The images contained herein are merely illustrative.
Manufacturer:
Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda.
Avenida Patriarca, 2223 - Ribeirão Preto/SP – Brasil
ZIP CODE 14031-580.
CNPJ MF 55.983.274/0001-30
I.E. 582.013.221.111
Contacts:
Phone: (16) 3919-9350
Fax: (16) 3919-9351
SAC: 0800 18 3111
Email: comercial@olidef.com.br
Site: www.olidef.com.br
Brazilian Industry
Register at ANVISA: 10227180028
Technical Responsible: Clayton André dos Santos

CREA: 5061591003/SP
Representative in the European community: OBELIS S.A.

Av.Tervuren, 34 bte 44, B-1040, Brussels, Belgium
Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda. declares that this product complies with the
Brazilian standards, national regulator bodies and the Directives 93/42/EEC of the European Council
concerning medical devices when used according to the instructions provided by the user and technical
guides.
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SUMMARY
1 - IDENTIFICATION ....................................................................................................................................... - 5 -
1.1 - NAME AND MODEL..............................................................................................................................- 5 -
1.2 - PRODUCT DESCRIPTION ...................................................................................................................- 5 -
1.3 - PHYSICAL PRINCIPLES ......................................................................................................................- 6 -
1.4 - PARTS AND ACCESSORIES: ..............................................................................................................- 6 -
1.4.1 – CONTROL MODULE – 1 (MC1) ................................................................................................... - 7 -
1.4.2 - DOME ............................................................................................................................................ - 7 -
1.4.3 - BED WITH MATTRESS ................................................................................................................ - 8 -
1.4.4 - BED TILT – CONVENTIONAL SYSTEM ...................................................................................... - 9 -
1.4.5 – BODY .......................................................................................................................................... - 10 -
1.4.6 – CONVENTIONAL SUPPORT ..................................................................................................... - 10 -
1.4.7 - AIR FILTER ................................................................................................................................. - 11 -
1.4.8 - WATER LEVEL INDICATOR- PASSIVE HUMIDIFICATION ...................................................... - 11 -
1.4.9 - LIMITING OXYGEN VALVE ........................................................................................................ - 12 -
1.4.10 - RN SENSOR (CODE 520041143030) ...................................................................................... - 12 -
1.4.11 - SECONDARY RECHARGEABLE BATTERY (CODE 2650010504) ........................................ - 13 -
1.5 - OPTIONALS, ACCESSORIES AND CONSUMPTION MATERIAL .....................................................- 13 -
1.5.1 - CONTROL MODULE – 2 (MC2).................................................................................................. - 13 -
1.5.2 - CONTROL MODULE – 3 (MC3).................................................................................................. - 14 -
1.5.3 - SERVOCONTROLLED SYSTEM FOR HUMIDITY .................................................................... - 14 -
1.5.4 - SERVO CONTROLLED SYSTEM FOR OXYGEN ..................................................................... - 15 -
1.5.5 - INTEGRATED OXIMETRY SYSTEM .......................................................................................... - 16 -
1.5.6 - EXTENDER CABLE FOR OXIMETRY SENSOR (CODE 2650010403) .................................... - 16 -
1.5.7 - Y-TYPE OXIMETRY SENSOR (CODE 2650010443) ................................................................ - 17 -
1.5.8 - INTEGRATED BALANCE............................................................................................................ - 17 -
1.5.9 - BALANCE LC 5 ........................................................................................................................... - 18 -
1.5.10 - SERIAL COMMUNICATION SYSTEM ...................................................................................... - 18 -
1.5.11 - DOME WITH DOUBLE DOWEL................................................................................................ - 19 -
1.5.12 - DOME WITH FRONT AND REAR ACCESS COVER ............................................................... - 19 -
1.5.13 -DOME WITH DOUBLE DOWEL AND FRONT AND REAR PORT............................................ - 20 -
1.5.14 - INTERNAL DOME ..................................................................................................................... - 20 -
1.5.15 - INTERNAL DOME W/ REAR PORT ......................................................................................... - 21 -
1.5.16 - MONITOR SUPPORT ............................................................................................................... - 21 -
1.5.17 - LOWER SERUM SUPPORT ..................................................................................................... - 22 -
1.5.18 - HIGHER SERUM SUPPORT .................................................................................................... - 22 -
1.5.19 - BALANCE SUPPORT ............................................................................................................... - 23 -
1.5.20 - AUXILIARY LIGHTING .............................................................................................................. - 23 -
1.5.21 - INTEGRAL BUMPER ................................................................................................................ - 24 -
1.5.22 - AUXILIARY OUTLETS .............................................................................................................. - 24 -
1.5.23 - DRAWER FOR X-RAY .............................................................................................................. - 25 -
1.5.24 - SYSTEM OF BED CONTINUOUS TILT.................................................................................... - 25 -
1.5.25 - SUPPORT WITH HEIGHT SET SYSTEM ................................................................................ - 25 -
1.5.26 - EXTERNAL BOX IN ALUMINUM .............................................................................................. - 26 -
1.5.27 - DETACHABLE SUPPORT ........................................................................................................ - 27 -
1.5.28 - DOUBLE DRAWER ................................................................................................................... - 27 -
1.5.29 - LARGE DRAWER ..................................................................................................................... - 28 -
1.5.30 - CLOSET .................................................................................................................................... - 28 -
1.5.31 - AUTOCLAVABLE WATER TANK ............................................................................................. - 28 -
1.5.32 - ICE TANK .................................................................................................................................. - 29 -
1.5.33 - INDICATOR TO USE OXYGEN ................................................................................................ - 29 -
1.5.34 - PASSIVE OXYGEN VALVE ...................................................................................................... - 29 -
1.5.35 - HOSE FOR OXYGEN (CODE 2650010470) ............................................................................ - 30 -
1.5.36 - HOSE FOR COMPRESSED AIR (CODE 2650010902) ........................................................... - 30 -
1.5.37 - CASTER OF 5” .......................................................................................................................... - 30 -
1.5.38 - CASTER OF 6” .......................................................................................................................... - 30 -
1.5.39 - DISPOSABLE RN SENSOR (code 2600040050) ..................................................................... - 31 -
1.5.40 - AUXILIARY TEMPERATURE SENSOR (CODE 2600040040) ................................................ - 31 -
1.5.41 - COVER FOR AUTOCLAVABLE MATTRESS (CODE 1450000078) ........................................ - 31 -
1.5.42 - GEL MATTRESS (CODE 2650010349) .................................................................................... - 31 -
1.5.43 - ADAPTER FOR VENT TUBES (CODE 548081121080) .......................................................... - 32 -
1.5.44 - TRIPLE RULE SET ................................................................................................................... - 32 -
1.5.45 - NEBULIZER (CODE 5010000014) ........................................................................................... - 32 -
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1.5.46 - MANUAL RESUSCITATOR ...................................................................................................... - 33 -
1.5.47 - HOOD FOR OXYGEN THERAPY ............................................................................................. - 33 -
1.5.48 - HALOGEN PHOTOTHERAPY .................................................................................................. - 34 -
1.5.49 - DISINFECTION TANK ............................................................................................................... - 34 -
1.5.50 - AIR FILTER ............................................................................................................................... - 34 -
1.5.51 - ADHESIVES FOR OXYMETRY SENSOR ................................................................................ - 35 -
1.5.52 - ADHESIVES FOR RN SENSOR (CODE 548051121080) ........................................................ - 35 -
1.5.53 - EYE SHIELD FOR PHOTOTHERAPY ...................................................................................... - 35 -
1.6 - TECHNICAL SPECIFICATIONS .........................................................................................................- 36 -
1.6.1 - SYMBOLS USED IN EQUIPMENT ............................................................................................. - 38 -
2 - SPECIAL CONDITIONS OF STORAGE, PRESERVATION AND/OR HANDLING OF PRODUCT:...... - 39 -
2.1 - BEFORE INSTALLATION: ..................................................................................................................- 39 -
2.2 - AFTER INSTALLATION: .....................................................................................................................- 40 -
3 - WARNINGS AND/OR PRECAUTIONS TO BE TAKEN .......................................................................... - 40 -
3.1 - OXYGEN .............................................................................................................................................- 42 -
3.2 - INTEGRATED OXYMETRY ................................................................................................................- 42 -
4 - PERFORMANCES ON ESSENTIAL SAFETY REQUIREMENTS AND EFFICACY OF MEDICAL
PRODUCT ..................................................................................................................................................... - 43 -
4.1 - INDICATION, PURPOSE OR USE THAT THE PRODUCT IS INTENDED .......................................- 43 -
4.2 - SAFETY AND EFFICACY OF PRODUCT: .........................................................................................- 43 -
5 - USE WITH OTHER EQUIPMENT ............................................................................................................ - 46 -
6 - INSTALLATION AND OPERATION ........................................................................................................ - 47 -
6.1 - INSTALLATION OF EQUIPMENT .......................................................................................................- 47 -
6.1.1 - UNPACKING ............................................................................................................................... - 47 -
6.1.2 - PRELIMINARY CHECKING ........................................................................................................ - 47 -
6.1.3 - ASSEMBLY OF EQUIPMENT ..................................................................................................... - 47 -
6.1.4 - ASSEMBLY OF EQUIPMENT WITH HEIGHT ADJUSTMENT SUPPORT (OPTIONAL) .......... - 48 -
6.1.5 INSTALLATION OF MONITOR SUPPORT (OPTIONAL) ............................................................. - 49 -
6.1.7 INSTALLATION OF GREATER SERUM SUPPORT (OPTIONAL) .............................................. - 50 -
6.1.8 - INSTALLATION OF AUXILIARY LAMP (OPTIONAL) ................................................................ - 51 -
6.1.9 - INSTALLATION OF INTEGRATED OXIMETRY (OPTIONAL) ................................................... - 51 -
6.1.10 - INSTALLATION OF INTEGRATED BALANCE (OPTIONAL) ................................................... - 52 -
6.1.11 - INSTALLATION OF LC5 BALANCE (OPTIONAL) .................................................................... - 53 -
6.1.12-INSTALLATION OF PHOTOTHERAPY (OPTIONAL) ................................................................ - 54 -
6.1.13 - INSTALLATION OF NEBULIZER (OPTIONAL) ........................................................................ - 54 -
6.1.14 - INSTALLATION OF AUXILIARY TEMPERATURE SENSOR (OPTIONAL) ......................... - 55 -
6.2 - TURNING ON THE SCTI LINE 4 INCUBATOR - MC1 .........................................................................- 56 -
6.2.1 - USE OF AR MODE ..................................................................................................................... - 56 -
6.2.2 - USE OF RN MODE ..................................................................................................................... - 58 -
6.2.3- HUMIDITY CONTROL .................................................................................................................. - 60 -
6.2.4 - OXYGEN CONTROL ................................................................................................................... - 60 -
6.2.5 LC5 BALANCE (OPTIONAL MODULE) ........................................................................................ - 63 -
6.2.6 - ADDITIONAL RESOURCES ....................................................................................................... - 63 -
6.2.6.1 - LOCK KEY ............................................................................................................................ - 63 -
6.2.7 - OPERATION OF ALARMS.......................................................................................................... - 63 -
6.2.8 - CHECK OF ALARM SYSTEMS .................................................................................................. - 66 -
6.3.1 - USE OF AR MODE ..................................................................................................................... - 67 -
6.3.2 - USE OF RN MODE ..................................................................................................................... - 69 -
6.3.3 - HUMIDITY CONTROL................................................................................................................. - 71 -
6.3.4 - OXYGEN CONTROL ................................................................................................................... - 72 -
6.3.5 INTEGRATED BALANCE (OPTIONAL MODULE)........................................................................ - 75 -
6.3.6 SERIAL COMMUNICATION .......................................................................................................... - 75 -
6.3.7.1 - LOCK KEY ............................................................................................................................ - 76 -
6.3.8 - OPERATION OF ALARMS.......................................................................................................... - 77 -
6.3.9 - CHECK OF ALARMS SYSTEM .................................................................................................. - 80 -
6.4.1 - USE OF AR MODE ..................................................................................................................... - 82 -
6.4.2 - USE OF RN MODE ..................................................................................................................... - 83 -
6.4.3- HUMIDITY CONTROL .................................................................................................................. - 85 -
6.4.4 - OXYGEN CONTROL ................................................................................................................... - 87 -
6.4.5 OXYMETRY OF INTEGRATED PULSE (OPTIONAL MODULE) ................................................. - 91 -
6.4.6 - INTEGRATED BALANCE (OPTIONAL MODULE) ..................................................................... - 94 -
6.4.7 SERIAL COMMUNICATION .......................................................................................................... - 94 -
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6.4.8 - TREND GRAPHICS .................................................................................................................... - 95 -
6.4.9.1 - KEYBOARD LOCK ............................................................................................................... - 98 -
6.4.9.2 - DATE AND HOUR ................................................................................................................ - 99 -
6.4.9.3 - CONTRAST ........................................................................................................................ - 100 -
6.4.9.4 - KANGAROO MODE ........................................................................................................... - 101 -
6.4.9.5 - NIGHT MODE ..................................................................................................................... - 101 -
6.4.10 - OPERATION OF ALARMS...................................................................................................... - 102 -
6.4.11 - CHECK OF ALARMS SYSTEM .............................................................................................. - 107 -
7 - MAINTENANCE ..................................................................................................................................... - 108 -
7.1 - PREVENTIVE MAINTENANCE .........................................................................................................- 108 -
7.2 - PERIODIC MAINTENANCE ..............................................................................................................- 109 -
7.2.1 - AIR FILTER EXCHANGE .......................................................................................................... - 110 -
7.2.2 - EXCHANGE OF AIR FILTER OF THE PASSIVE OXYGEN VALVE ........................................ - 110 -
7.2.3 - EXCHANGE OF AIR FILTER OF THE LIMITING OXYGEN VALVE ........................................ - 110 -
7.2.4 - EXCHANGE OF AIR FILTER OF SERVO CONTROLLED OXYGEN VALVE ......................... - 111 -
7.2.5 - FUSE EXCHANGE .................................................................................................................... - 111 -
8 - CLEANING AND DISINFECTION .......................................................................................................... - 113 -
8.1 - CLEANING ........................................................................................................................................- 113 -
8.2 - DISINFECTION .................................................................................................................................- 120 -
9 - TROUBLESHOOTING ........................................................................................................................... - 120 -
10 - WARRANTY ......................................................................................................................................... - 121 -
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1 - IDENTIFICATION
1.1 - NAME AND MODEL
Technical name: Incubator for newborn
Trade name: Incubator for newborn
Business model: SCTI LINE 4
Figure 1 – Incubator for Newborn SCTI LINE 4
1.2 - PRODUCT DESCRIPTION

The Incubator for Newborn model SCTI LINE 4 is a product of advanced technology in which quality, efficiency
and ease of use factors combine to provide full satisfaction to the user and comfort to the small patient. This
product was developed to provide ideal thermal comfort for newborns - born human, and especially for
premature and newborn in risk, providing favorable environmental conditions to those presenting disorders in
the neonatal period or body thermoregulation impairment.
With extremely quiet operation resulting in less discomfort for the patient, this incubator offers temperature
control in AR (ATC) and RN (ITC) modes optional as servo controlled functions of relative humidity and
oxygen concentration, thus achieving high concentrations of relative humidity and oxygen inside the newborn
compartment, respectively, and integrated pulse oxymetry, integrated balance allowing to monitor the patient
weight without removal from the controlled environment, front control panel that synthesizes all adjustment
and monitoring options in a simple and practical manner with trend graphs for treatment and diagnosis through
an interactive menu.
In the AR mode the incubator keeps the air temperature stable inside the newborn compartment, comparing
the air temperature within the dome with the temperature control set by the operator. If the air temperature is
high, the heating resistance is turned off until the air temperature falls below the value preset by the operator.
In the RN mode, the incubator sets the heating based on the temperature value read to the skin of newborn
and the RN temperature set by the operator. To maintain constant the patient temperature, close to the value
set by the operator, the control panel of the incubator will compare the temperature measured by the sensor of
RN with the temperature set by the operator by increasing or decreasing the air temperature inside the
incubator as varying the temperature of the patient skin.
The RN compartment has a wide and ergonomic dome with a clear acrylic wall of high resistance provided
with two folding ports (front and rear), allowing access to the patient without removal and passages for tubes
with flexible sealing system. The dome has five portholes with sleeve cuff and "touch of elbow" system
distributed as follows, two portholes on the front, two portholes on the back and one on the right side. Iris
sleeve on the left side and eight passages of tubes are offered, all positioned in the corners offering full
opening for the newborn procedures.
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The bed is made of nontoxic radiolucent plastic; it has wide dimensions and can be moved out of the dome
through guides facilitating access to the newborn for additional procedures. The bed also has continuous
system with manual-tilt set, obtaining trendelemburg and inclined positions, and high and low horizontal. A
drawer to the radiographic chassis can be placed under the bed for X-ray procedures.
The equipment is also equipped with auxiliary lighting to enhance the patient view in dark environments.
The incubator was built to operate at power supply of 127/220V~.
To read the values of temperature of AR and RN, the Incubator SCTI LINE 4 has electronic sensors with high
degree of accuracy. These temperatures are displayed independently in the panel display allowing continuous
check.
Aiming the patient and operator safety, the incubator has a complete electronic audiovisual alarm system to
situations of irregularity in the equipment with automatic operation. In both modes of operation, there are
alarms of air circulation lack, cold air, hot air, hypothermia, hyperthermia, overheating, lack of energy and
sensor failure in the equipment.
1.3 - PHYSICAL PRINCIPLES

The Incubator for Newborn model SCTI LINE 4 comprises a body built for the purpose of holding a human
newborn (RN), allowing its view through a clear acrylic dome with double wall. Inside the newborn
compartment, the environmental conditions can be maintained as the RN needs by maintaining the air
heating, increasing the oxygen concentration and relative humidity beyond soundproofing and low noise level
produced by the equipment. To ensure best environmental conditions for the patient, air and oxygen admitted
into the apparatus are filtered independently to prevent the passage of particles larger than 0.5 micron,
providing an internal air with the highest purity, and temperature controls, moisture and oxygen from the
incubator are performed by a system of forced air circulation where a controlled amount of air is sucked by an
engine through the intake air filter, humidified and enriched with oxygen is distributed uniformly to the control
environment newborn compartment. This system keeps the internal air circulation micro filtered and properly
heated, and this air flow passes directly with sensors of temperature, humidity and oxygen control, and such
system also prevents the accumulation of carbon dioxide inside the compartment.
1.4 - PARTS AND ACCESSORIES:
Figure 2 – Isometric view of Incubator for Newborn model: SCTI LINE 4
1 Control Module 8 Porthole w/ touch of elbow (5x)

2 Acrylic dome 9 Iris sleeve
3 Support 10 Limiting oxygen valve
4 Transport strap 11 Water Level Indicator
5 Body 12 4" Caster with lock (4x)
6 Handle of conv. syst. for bed tilt 13 Tubes passages
7 Bed 14 Nebulizer Coupler
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1.4.1 – CONTROL MODULE – 1 (MC1)
1-Power Inlet
2-Control Panel
3-Fan
4-Resistance
5-Fuse ports
6-General Key
7-Skin Sensor
Figure 3 – Control module - 1

This equipment module contains inside all electronic components and devices responsible for the correct
operation of the incubator SCTI LINE 4. It has a front panel with smooth surface that provides greater ease in
cleaning, where the keys are located, seven-segment numeric displays, LED indicators and a side panel for
connection of sensors and cables.
This panel can be removed for cleaning and maintenance by pushing the safety lock quickly and easily without
the use of tools.
In this standard control panel (MC1), you can view and set the temperature of AR and the patient (RN) and
security alarms. Two other control modules with additional functions are offered as optional items (see item
1.5.1 and 1.5.2).
At the rear of the control panel are temperature sensors, heating and air circulation. Electronic sensors with
high degree of accuracy are responsible for air monitoring and security alarms of the incubator.
- Resistance - built with tubular reinforced structure, stainless steel has activation by micro processed
electronic circuit and extra protection in stainless steel.
- Motor - Its function is to boost the air to the RN compartment taking heat and humidity to the patient. For this,
an electric motor activates a fan that pulls the environment air passing through a filter, which is then directed
to the heating resistance and the water tank. The heated and humidified air (if the container is filled with water)
reaches the RN compartment being continuously renewed thereby avoiding the concentration of CO2 within
the dome.
- Temperature and air circulation sensors - Electronic sensors with high degree of accuracy are responsible for
monitoring air temperature and security alarms of the incubator.
For more information about using this control panel, see item 6.2.
1.4.2 - DOME
The Incubator Dome for Newborns SCTI LINE 4 is built in a biocompatible transparent acrylic (ISO 10993-1),
has rectangular shape and a folding port for intensive care in the front port to facilitate the patient access. It
has openings for hand passage with wrist sleeves and oval portholes with nontoxic silicone sealing activated
by touch to elbow. The side has an opening for tube system with iris sleeve. The dome also has passages for
flexible cables and even supports as optional double wall, which are internal walls that facilitate to maintain the
patient temperature.
-7-
Figure 4 – Dome
A – DOME: Made of transparent acrylic, front access port, passages for hands with oval portholes (B),
passage for tube with iris sleeve system (D) and passages for tubes (E).
B - PORTHOLES: Made of transparent plastic material with high mechanical resistance, they have flexible
silicone sealing and removable wrist sleeve which provide perfect sealing preventing sudden changes in air
temperature in the RN compartment. There are five portholes distributed in the dome as follows; two portholes
on the front, two portholes on the rear and one on the right side. The opening of portholes is made by a latch
activated by the touch to elbow, avoiding hand contamination before access the patient.
C - FRONT COVER: Allows quick and secure access to the patient, minimizing heat losses inside the RN
compartment. To open the cover, it should trigger the latches located on its higher part (F).
D - IRIS PORTHOLE: Allows the passage of tubes in the newborn compartment.
E - PASSAGES OF TUBES: Positioned in places of easy access at the intensive care cover opening, these
devices are used for pipe and cable passages, allowing easy removal of the RN without requiring the removal
of such devices (4 passages of tube are installed in the dome).
F - LATCH: To open the access ports, rotate the latches (F).
G - NEBULIZER COUPLER: Device located on the left side of the dome, allowing adaptation of external
nebulizer. It has plastic cover that shall be closed when the coupler is not been used.
Note: The dome may suffer changes in the number of covers and openings according to the customer needs.
1.4.3 - BED WITH MATTRESS

The bed with mattress can be moved up to 16 cm out of the dome coming out from the front access port. A
safety latch prevents the full out of the bed, as shown in Figure 6.
Figure 5 – Mattress bed
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1- Mattress
2- Mattress tray
3-Platform
Figure 6 – Mattress bed composition
The newborn bed consists of 3 main parts: the mattress tray, the mattress and the platform.
Parts of the newborn bed:

1- Mattress Tray: is made of plastic material, transparent to x-rays, with anatomical shape and no sharp
corners.
2-Mattress: Made of foam coated with non-toxic and hypoallergenic plastic cover according to the guidelines
and principles of ISO 10993-1.
3 - Platform built in aluminum, with two tabs located below the tray allowing the mattress tray to be moved out
of facilitating access to the patient. These tabs have a safety latch that limits the current and prevents the
accidental dropping of the tray.
Under the platform there is a ground connection point. To ensure the patient and the operator protection
against electrical shock, check if the platform is fully seated by pressing it down with both hands before you
accommodate a new patient.
CAUTION
- The maximum load on the bed should not exceed 10 kg.
1.4.4 - BED TILT – CONVENTIONAL SYSTEM

The incubator bed SCTI LINE 4 can be tilted in the Trendelembug / Reverse positions.
Figure 7- Activation of the tilt system
Equipped with two metal levers (A) with anti-corrosion and chrome treatment positioned near the dome (A),
this system allows the bed tilt in 12º in the Trendelenburg and Reverse positions.
If both levers are activated simultaneously, the bed will be placed in a high horizontal position.
Note: The levers can be supplied in polished stainless steel.
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1.4.5 – BODY
1- Front (panel)
2 - Inner Basin
3 - Right side (key switch and fuses)
4 - Left side (humidification and oxygen)
5 - Rear (filter)
Figure 8 - Incubator body
The incubator SCTI LINE 4 body consists of 2 main parts. The aluminum basin and the outer box.
-The outer box of the incubator body is built in metal sheet with anti-corrosion treatment and painted with
epoxy paint.
1- Front: In this part of the incubator body is installed the control module and its lock system.
2- Right side: contains the opening for cable connection to the control module and one of the hand straps for
transportation.
3- Left side: contains the following devices installed: water level indicator for passive humidification, limiting
oxygen valve, hand strap for transport, oxygen inlet valve servo controlled (optional) and water tank (optional).
4 - Rear: contains the air filter cover
- Inner Basin
The inner basin is composed by one treated and painted cast aluminum part with tank for distilled water, air
conductor and chamber for recirculation.
The air conductor aims to direct the air flow in the right direction, thus leading to the hot and moist air into the
RN compartment.
Figure 9 – Inner basin
1.4.6 – CONVENTIONAL SUPPORT

Consist of a metal structure equipped with four 4-inch casters with locks, the support provides ease and safety
during the incubator transport. In the support can be installed the following accessories: bumper, closet with
shelf, drawer, large drawer and casters of 5-6 inches.
- 10 -
Figure 10 - Incubator support
Note: This conventional support can be provided in aluminum.
1.4.7 - AIR FILTER

The air filter located at the incubator rear has the function of air filtering which enters the RN compartment.
Particles larger than 0.5 micron will not go through the air filter, thus ensuring a high degree of purity inside the
newborn compartment.
Figure 11 – Air filter location

CAUTION
- Openings in the filter cover are inlet and should not be obstructed.
- It is recommended to change the air filter every ninety days. See Section 7.2.1 - Replacement of
air filter
- The dirty air filter results in the carbon dioxide increase higher than the oxygen level inside the
incubator.
1.4.8 - WATER LEVEL INDICATOR- PASSIVE HUMIDIFICATION

The incubator SCTI LINE 4 has a passive humidification system to increase the concentration of relative
humidity within the RN compartment. This is possible by the existence of an internal tank located in the
aluminum basin w/ 3L capacity and can be monitored the water level in the tank through the level indicator (A)
located on the outer side of the body, as shown in Figure 12.
- 11 -
Figure 12 – Water level indicator- passive humidification
1.4.9 - LIMITING OXYGEN VALVE

(Accessory exclusively for the SCTI LINE 4 incubator)
The SCTI LINE 4 Incubator for Newborns has an oxygen inlet valve on the left side, as shown below. It
comprises an inlet nozzle for hose ø ¼’, a filter for retaining impurities and a mechanical system that blocks
the O2 inlet when the flow exceeds 8Lpm.
Figure 13 – Limiting valve location

Note: The valve can leave the manufacture set to other flows according to the customer request.
Note:
- For filter replacement see item 7.2.3 - Replacing the filter of the limiting oxygen valve
1.4.10 - RN SENSOR (CODE 520041143030)

(Accessory exclusively for the SCTI LINE 4 incubator)
The RN sensor (Figure 14) measures the temperature of the patient skin, providing accurate and reliable
reading. The appropriate thermal contact of the sensor with the newborn skin is essential for accurate reading
of the patient temperature. If this contact is not perfect, there may be a false temperature reading. The
indication of the patient skin temperature is taken by the control module.
The skin temperature sensor provides an advanced architecture and makes the patient fixation system is
simpler but more stable and efficient at the same time.
Your isolation system between the skin and the environment allows a safe and reliable measurement, ideal for
working in different fields and areas getting better results.
1- Skin Sensor (encapsulated with biocompatible titanium, according

to ISO 10993-1)
2 - Cable
3 - 4-way connector
(Note: To servo controlled system the connector will be a P2 blue
color)
Figure 14 – RN Sensor
- 12 -
1.4.11 - SECONDARY RECHARGEABLE BATTERY (CODE 2650010504)
The Newborns Incubator SCTI LINE 4 features a rechargeable Nickel Cadmium battery (NiCd - 8.4V), which
has the function to keep the system in limited operation and a sound alarm if the battery fails.
This battery is automatically recharged when the equipment is plugged in, and its useful life is 12 months.
After this time, the battery should be replaced by a new original one.
1.5 - OPTIONALS, ACCESSORIES AND CONSUMPTION MATERIAL

Note:
- The optional, accessories and consumable materials for non-exclusive use described in this manual have
their own records at ANVISA, therefore, they are not an integral part of the Newborn Incubator model SCTI
LINE 4 record.
- Before using the accessories, please read the instructions in this chapter.
1.5.1 - CONTROL MODULE – 2 (MC2)

(Optional exclusively for the SCTI LINE 4 incubator)
This module has all existing resources in the control mode - 1, and also has optional: servo controlled
humidifier, integrated balance and output to PC.
The panel has all existing resources in the control standard panel, the difference is an alphanumeric LCD
display, keyboard inclusion for control of humidity control and balance.
The servo-controlled humidifier allows setting the relative concentration of humidity inside the newborn
compartment as setting made by the incubator operator.
The integrated balance indicates the patient weight in the own alphanumeric display on the front panel of the
incubator.
The RS 232 output allows a PC to be connected to the incubator and using appropriate software and the
parameters shown in the incubator display can be viewed on a PC, enabling the storage of this information,
print of trend graphs, etc.
1- Fuse holders
2 - Serial output
3 - Sensor Module
4 - Power inlet
5 - Balance Sensor
6 - General Key
7 - Fan
8 - Resistance
9 - Control Panel
10- humidification module
Figure 15 - Control module - 2

The panel can be removed for cleaning and maintenance by activation of the safety lock quickly and easily
without the use of tools.
At the rear of control panel are located the heating temperature and air circulation sensors: Electronic sensors
with high degree of accuracy are responsible for air monitoring and security alarms of the incubator.
Resistance - built with tubular reinforced structure, stainless steel, has activation by micro processed
the dome.
Note:
- Optional item.
- 13 -
1.5.2 - CONTROL MODULE – 3 (MC3)
(Optional exclusively for use in the SCTI LINE 4 incubator)
This module has all existing resources in the control mode - 1 and also optional: servo controlled humidifier,
integrated balance, output to PC, skin sensor auxiliary, oxygen servo controlled system, pulse oxymetry
system integrated and allows viewing trend graphs for the last 60 hours.
The panel has all existing resources in the standard control panel; the differential is due to a graphical display
of 6" and inclusion of humidity control keys, balance, oxygen oxymetry and plethysmographic curve.
1- Fuse holders
2 - humidification module
3 - Sensor Module
4 - Oxymetry Sensor
5 - Fan
6 - Resistance
7 - Control Panel
8 - balance Sensor
9 - serial output
10 - Power Inlet
11 - General Key
Figure 16 - Control module - 3

The panel can be removed for cleaning and maintenance by activation of the safety lock quickly and easily
without the use of tools.
At the rear of control panel are located the heating temperature and air circulation sensors: Electronic sensors
with high degree of accuracy are responsible for air monitoring and security alarms of the incubator.
- Resistance - built with tubular reinforced structure, stainless steel, has activation by micro processed
the dome.
Note:
- Optional item.
1.5.3 - SERVOCONTROLLED SYSTEM FOR HUMIDITY

This system allows monitoring and controlling the relative air humidity within the newborn compartment. The
humidity is generated by means of a tubular resistance that heats the water tank which in turn evaporates, the
heated and humidified air enters the air circulation of the incubator not changing the temperature of the
newborn compartment, thereby creating a stable environment with uniform distribution of heat. This system
minimizes heat losses by evaporation, especially for premature. There is no need for external humidification to
humidify the newborn compartment.
The whole system has a plastic tank with a capacity of 3L, is removable for easy cleaning and make practical
the cleaning and sterilization of the entire humidification system
Sets can be made with increments of 1% to every touch as directed by the medical attendant.
The humidity control ranges from 20% to 95%. Concentration desired and the actual value is shown on the
display of the control module.
- 14 -
Note: Optional available only for MC2 and MC3 control modules
Figure 17 – MC2 Display panel– humidity control Figure 18 – MC3 Display panel– humidity control
Figure 19 – humidity drawer

Note:
- Optional item.
1.5.4 - SERVO CONTROLLED SYSTEM FOR OXYGEN

The use of this system allows monitoring and control of oxygen concentration in the newborn compartment.
The system comprises an inlet connection with 9/16" thread- 18UNF a filter for retention of impurities
mechanical system that limits the inlet pressure to 3.5 kgf/cm², solenoid valve which limits the flow to 64 Lpm
and accuracy sensors.
The desired concentration and the actual value are displayed in the graphical display of the control module
and incremented by 1% to every touch. The adjustments should follow guidance as medical attendant.
The control range of oxygen from 21% to 65% with a maximum pressure of 3.5 kgf/cm² and a maximum flow
of 64 Lpm.
To enhance the patient safety, many alarms are available when this optional is installed in the incubator.
Note: Optional available only for the MC3 control module.
Figure 20 – Oxygen servo control valve Figure 21 – MC3 Display panel– Oxygen control
Note:
- Optional item.
- 15 -
1.5.5 - INTEGRATED OXIMETRY SYSTEM
This item is available regardless other optional, comprising a pair of biocompatible reusable sensors (ISO
10993) fixation adhesive kit and an electronic plate. It is a pulse oximeter to be used as continuous non-
invasive monitor of arterial oxygen (SpO2) and pulse rate that works with the application of a sensor that
contains a dual light source and a photodetector to a pulsatile arterial vascular bed as, for example, a finger.
This system was developed to measure the functional oxygen saturation in the blood. Readings are updated
every second on the display and the values shown are obtained through an arithmetic medium of 15 readings.
The use of an oxymetry system allows viewing of patient's vital parameters in the display control panel of the
incubator:
- Heart rate (BPM)
- Rate of saturated hemoglobin with oxygen in the blood (SpO2)
- Plethysmographic curve
The oxymetry system allows the increase of a unit to set the limits of maximum and minimum rates of SpO2
and BPM alarms activation as oriented by the medical attendant.
The monitoring range of SpO2 ranges from 0 to 100% and the maximum and minimum limits of alarm
activation of 50 to 100% can be set.
The monitoring range of BPM ranges from 20 to 250 bpm and the maximum and minimum limits of alarm
activation of 40 to 250 bpm can be set.
This oxymetry system is manufacture-calibrated, and the calibration is made within the ranges monitoring of
SpO2 and BPM.
Note: Optional available only for MC3 control module.
Description Olidef Code

Oxymetry Sensor Kit 1 2650010442
Oxymetry Sensor Kit 2 2650010444
Figure 22 – MC3 Display panel - Oxymetry
Figure 23 - Oxymetry sensor 1 Figure 24- Oxymetry sensor 2

Note:
- Optional item.
1.5.6 - EXTENDER CABLE FOR OXIMETRY SENSOR (CODE 2650010403)

(Accessory exclusively for use of the SCTI LINE 4 incubator)
- 16 -
To use this extender allows increasing the length of the oxymetry sensor cable.
In order to use the extender, connect in the module panel of incubator sensors and the other end directly into
the sensor cable.
Figure 25 - extender cable

Note:
- Optional item.
1.5.7 - Y-TYPE OXIMETRY SENSOR (CODE 2650010443)

Performs the same function of the conventional oxymetry sensor, allowing a reliable and accurate reading of
the patient's vital parameters. This product is compliant with ISO 10993.
Figure 26 - Sensor type Y

Note:
- Optional item.
1.5.8 - INTEGRATED BALANCE

The integrated balance for the SCTI LINE 4 Olidef incubator bed has load capacity of 10Kg and accuracy of ±
5g may indicate the patient's weight without removing them from the controlled environment offered by the
incubator. The balance plate is built with biocompatible plastic material (ISO 10993-1). The patient's weight is
indicated on the display panel of the incubator control module. The balance also has two functions: Add and
tare.
The use of this optional is restricted to the MC2 and MC3 control module.
Note: The use of balance does not difficult the use of a drawer for X-ray chassis since the weighing sensors of the balance plate are
located at the ends leaving the entire central part of the mattress free for the x-rays passage.
Figure 27 – Control Module Panel - 2
- 17 -
Figure 28 - Control Module Panel - 3
Note:
- Optional item.
1.5.9 - BALANCE LC 5
The SCTI LINE 4 incubator can be used jointly with this accessory, which allows the user to weigh the patient
inside the equipment, preventing the baby to be removed from the controlled environment incubator. The
balance consists of two main parts: the plate and balance display (built in biocompatible plastic material - ISO
10993-1), as shown in Figure 28. The balance for Olidef incubator has a load capacity up to 10kg and
accuracy of ± 5g. The patient's weight is indicated on the balance display, as shown in figure 30
Note: The use of balance does not difficult the use of a drawer for X-ray chassis since the weighing sensors of the balance plate are
located at the ends leaving the entire central part of the mattress free for the x-rays passage.
1– Display
2- Balance plate
3 - Balance Sensor
4 - General Key
5 - Fuse
6 - Power Inlet
Figure 29 – Balance LC 5
Figure 30 – Panel da balance LC 5
Note:
- Optional item.
1.5.10 - SERIAL COMMUNICATION SYSTEM

- 18 -
(Optional exclusively for use in the SCTI LINE incubator)
This system available for the MC2 and MC3 control modules allows the incubator to be connected to a PC and
has monitored its data, allowing the viewing of these parameters directly on the PC monitor. The system can
also store this information for later review or printing such data.
In order to access the system a cd for installing of monitoring software, RS232 connection cable for
PC/incubator and a user's guide (monitoring) is provided.
For more information about using this communication system, see item 6.3.6 or 6.4.7.
Note:
- Optional item.
1.5.11 - DOME WITH DOUBLE DOWEL

The Incubator Dome for Newborn model: SCTI LINE 4 is built in biocompatible transparent acrylic (ISO 10993-
1), has rectangular shape and to facilitate the patient access; the front has a folding port for intensive care. It
has openings for hands passage and wrist sleeves, and oval portholes with nontoxic silicone sealing, activated
by touch to elbow. The side has two tube passages with double dowel. The dome also has passages for
flexible cables and even supports an optional double wall, which are internal walls for easier maintenance of
the patient temperature.
Figure 31 – Dome with double dowel
A – DOME: Made of transparent acrylic, with a front access port, passages for hands with oval portholes (E),
passage for tube with double dowel (F) and passages for tubes (D).
B – LATCH: To open the access ports, rotate the latches (B).
C – FRONT COVER: Allows quick and secure access to the patient, minimizing heat losses inside the RN
compartment. To open the cover, it should trigger the latches located on its higher part (B).
D – PASSAGES OF TUBES: Positioned in places of easy access at the intensive care cover opening, these
devices are used for pipe and cable passages, allowing easy removal of the RN without requiring the removal
of such devices (8 passages of tube are installed in the dome – considering the double dowel (F).
E - PORTHOLES: built with transparent plastic material with high mechanical resistance, they have flexible
silicone sealing and removable wrist sleeve which provide perfect sealing preventing sudden changes in air
temperature in the RN compartment. There are five portholes distributed in the dome as follows; two portholes
on the front, two portholes on the rear and one on the right side. The opening of portholes is made by a latch
activated by the touch to elbow, avoiding hand contamination before access the patient.
F – DOUBLE DOWEL: Positioned on the right side of dome, allows the passage of tubes in the newborn
compartment. It is readily removable to facilitate cleaning and sterilization
G – NEBULIZER COUPLER: Device located on the left side of dome, allowing adaptation of external
nebulizer. It has plastic cover that shall be closed when the coupler is not been used.
Note: The dome may change the number of portholes, covers and openings in accordance with customer requirements.
Note:
- Optional item.
1.5.12 - DOME WITH FRONT AND REAR ACCESS COVER

- 19 -
This accessory facilitates access to the patient, allowing easy access to the newborn compartment by the front
and rear of the incubator. The biocompatible transparent acrylic dome (ISO 10993-1), with front and rear
access has 8 passages for tubes, contains 5 oval portholes with wrist sleeves and nontoxic silicone sealing,
activated by touch to elbow; the left side has an Iris sleeves system for tube passage and also support an
optional double wall which are inner walls to ease the maintenance of the patient temperature.
Figure 32 - Dome with front and rear access cover

Note:
- Optional item.
1.5.13 -DOME WITH DOUBLE DOWEL AND FRONT AND REAR PORT
This accessory facilitates the access to the patient allowing easy access to the newborn compartment by front
and rear of the incubator. The biocompatible transparent acrylic dome (ISO 10993-1), with front and rear
access has 12 passages for tubes, because it comes with two double dowels on the side of the dome,
contains 5 oval portholes with wrist sleeves and nontoxic silicone sealing, activated by touch to elbow; on the
left side has two double dowels for tube and also supports an optional double wall, which is an internal wall to
facilitate the maintenance of the patient temperature.
Figure 33 -Dome with double dowel and front and rear port
Note:
- Optional item.
1.5.14 - INTERNAL DOME

(Accessory exclusively for use in the SCTI LINE 4 incubator)
Built with biocompatible transparent acrylic (ISO 10993-1), the internal dome with the dome shapes a double
wall system with improved thermal insulation, enabling the reduction of heat losses inside the newborn
compartment, making easier to maintain the patient temperature. Divided into two parts: dome and front port
- 20 -
Figure 34 - internal dome
Note:
- Optional item.
1.5.15 - INTERNAL DOME W/ REAR PORT

Built with biocompatible transparent acrylic (ISO 10993-1), the internal dome with the dome shapes a double
wall system with improved thermal insulation, enabling the reduction of heat losses inside the newborn
compartment, making easier to maintain the patient temperature. Divided into three parts: dome, front port and
rear port
Figure 35 - Internal dome w/ rear port

Note:
- Optional item.
1.5.16 - MONITOR SUPPORT

This device allows placement of monitors, oximeters, infusion pumps and other apparatus for use with the
incubator. The support surface is swivel allowing the most suitable position for easy monitoring such
equipment by users and up to two monitor supports may be assembled per incubator. This accessory offers
two optional adjustable safety belts for fixing the equipment tray.
It can be made in painted carbon steel, painted/polished stainless steel.
- 21 -
Figure 36 - Monitor support
CAUTION
- Maximum load: 10Kg
Note:
- Optional item.
1.5.17 - LOWER SERUM SUPPORT

This support aims the placement of serum bags or ampoules. It has two or four hooks for fixation and may be
assembled up to two supports of lower serum in each incubator.
It can be made in chromed carbon steel or polished stainless steel.
Figure 37 - Lower serum support
CAUTION
- Maximum weight: 1 kg per hook
Note:
- Optional item.
1.5.18 - HIGHER SERUM SUPPORT

This optional aims the placement of serum bags or ampoules. It has two or four hooks for fixation and may be
assembled up to two supports of serum in each incubator. This accessory has adjustable height, total course
of 887 mm and maximum height of 1943 mm from the floor and a minimum of 1056 mm.
It can be made in chromed carbon steel or polished stainless steel.
- 22 -
Figure 38- Higher serum support
Note:
- Optional item.
1.5.19 - BALANCE SUPPORT

This optional aims the fixation of balance display (see Item 6.1.12) and must be installed on the monitor
supports. This device should be used only for Olidef balance, LC5 model.
Figure 39 - Support for assembled balance
Note:
- Optional item.
1.5.20 - AUXILIARY LIGHTING

The lighting is by white LED light that allows the viewing of the patient in environments with low or no lighting.
It has independent switch.
Figure 40 - Auxiliary lighting
Note:
- Optional item.
- 23 -
1.5.21 - INTEGRAL BUMPER
Provides protection around the whole incubator perimeter protecting it from impacts. It can also be used as
transport strap of the incubator. Built in aluminum.
Type A
Type B
Type C
Figure 41 - Bumpers
Note:
- Optional item.
1.5.22 - AUXILIARY OUTLETS

(Accessory exclusively for SCTI LINE 4 incubator)
These outlets located at the rear of the incubator allows that other equipment be connected to the equipment
avoiding the use of extensions. This accessory has four or six outlets, general key and electronic protector
against overload. Its main function is to serve as an extension to the electro medical equipment that is
supported on supports for monitors and/or trays for monitors. All outlets meet the standard NBR 14136. Its
power supply is independent of the incubator.
Auxiliary outlets kit - 4-way 2650010905
Auxiliary outlets kit - 6-way 2650010921
Figure 42- - Auxiliary outlets
CAUTION
- Maximum Power: 180W per outlet
Note:
- Optional item.
- 24 -
1.5.23 - DRAWER FOR X-RAY
Allows obtaining radiographs without the patient is removed from the incubator's bed.
Figure 43 - Drawer for x-ray

Note:
- Optional item.
1.5.24 - SYSTEM OF BED CONTINUOUS TILT

This system allows the bed continuous tilt of the incubator in the Trendelenburg and Reverse 12º positions.
The activation of this mechanism is held through plastic knobs (A) of high resistance located next to the dome,
as shown in the following figure:
If both knobs are activated simultaneously, the bed will be placed in a high horizontal position.
Figure 44 - Activation of continuous tilt system

Note:
- Optional item.
1.5.25 - SUPPORT WITH HEIGHT SET SYSTEM

This system allows a more suitable positioning for use in the incubator. The system activation of height set is
accomplished through pedals (A), located at the base of the incubator support, electrically activated, has a
total course of 200mm and comes equipped with four 4-inch casters with lock. In the support can be installed
in the following accessories: bumper, closet with shelf, drawers, great drawer and casters of 5-6 inches.
- 25 -
Figure 45 - Height set system for SCTI LINE 4 incubator
Figure 46 - Foot of height set system.

Note: Beyond the frontal activation, optionally, the incubator can count on the height set also done through the pedals located at the
equipment rear.
Note:
- Optional item.
1.5.26 - EXTERNAL BOX IN ALUMINUM

(optional exclusively for the SCTI LINE 4 incubator)
This optional is provided with external box of incubator body in aluminum, reducing the risk of oxidation, all
painted with epoxy paint, maintains the same external features of the incubator.
1 - Front (panel)
2 - Inner Basin
Figure 47 - Body of incubator in aluminum

Note:
- Optional item.
- 26 -
1.5.27 - DETACHABLE SUPPORT
This support has the same function as the conventional support with the advantage of reducing the package
size of the equipment. Built with carbon steel and anticorrosive treatment painted with epoxy paint is
comprised of four 4-inch casters with lock. This optional after mounted and fixed in the incubator has the same
setting possibilities of options and accessories offered in the conventional support.
The detachable support assembly should be performed as indicated in the following figure:
A- Allen screws
B- Tray
C- Casters
Figure 48 - Detachable support

Note: Support assembly:
- Install the upper and lower tubular structures fixing them with screws (A), using a 6 mm Allen key.
- Install the four casters (C), threading them on the bottom of the structure.
- Place the tray on the bottom of the structure.
Note: The detachable support can be provided in aluminum.
Note:
- Optional item.
1.5.28 - DOUBLE DRAWER

It can be coupled to the incubator support and allows the storage of various materials (up to two double
drawers can be installed per incubator)
Figure 49 - Drawer
Note:
- Optional item.
- 27 -
1.5.29 - LARGE DRAWER
It can be coupled to the incubator support and allows the storage of various materials (up to two large drawers
can be installed per incubator)
Figure 50- - Drawer

Note:
- Optional item.
1.5.30 - CLOSET
It can be coupled to the incubator support and allows the storage of various materials (up to two closets can
be installed per incubator)
Figure 51 - Closet
Note:
- Optional item.
1.5.31 - AUTOCLAVABLE WATER TANK

This tank built in polycarbonate, available for versions with and without servo controlled humidification system
has the same features as conventional tank with the advantage that it can be sterilized by autoclaving process
at temperatures up to 121°C.
Figure 52- Autoclavable water tank

Note:
- Optional item.
- 28 -
1.5.32 - ICE TANK
This device allows that the incubator temperature is reduced, if the equipment is installed on site without
proper temperature conditions.
To use this accessory, remove the tank (A) located on the left side of the incubator body and put ice to the
maximum level indicated, approximately 3L.
Figure 53 - Location of ice tank Figure 54 - Ice tank

Note:
- Optional item.
1.5.33 - INDICATOR TO USE OXYGEN

This device, located on the left side of the incubator body indicates that oxygen is being administered within
the newborn compartment.
To use the indicator, pull it upward, locking it in its place.
Figure 55 - Indicator Blocked oxygen inlet Figure 56 - Indicator activated: Released oxygen inlet
Note:
- Optional item.
1.5.34 - PASSIVE OXYGEN VALVE

The Newborn Incubator model: SCTI LINE 4 has a passive oxygen inlet (A) located on the left side as shown
below. It consists of a threaded 9/16" inlet connection - 18UNF, a filter for retention of impurities and a
mechanical system that blocks O2 inlet when the flow exceeds 64Lpm.
Note:
- We recommend the use of pressure and flow meter control valve (with the equipment).
- When the incubator has a servo control system with oxygen this possibility is not available
- For filter replacement see item 7.2.2 - Replacement of passive oxygen valve filter
- 29 -
Figure 57 - Location of passive valve
Note:
- Optional item.
1.5.35 - HOSE FOR OXYGEN (CODE 2650010470)

Pressure hose of braided nylon 150PSI nontoxic with thread 9/16 connections - 18UNF and 3.0 m length.
Figure 58 - Hose of braided nylon 150 PSI
Note:
- Optional item.
1.5.36 - HOSE FOR COMPRESSED AIR (CODE 2650010902)

Pressure hose of braided nylon 150PSI nontoxic with thread 3/8 connections - 18UNF and 3.0 m length.
Note:
- Optional item.
1.5.37 - CASTER OF 5”
The casters provided with equipment can be replaced by others with the diameter of 5 inches. This caster
increases the height of the incubator at 22 mm with the advantage of providing less effort to move the
incubator.
Note: All casters supplied to the incubator SCTI LINE 4 have locks.
Note:
- Optional item.
1.5.38 - CASTER OF 6”
The casters provided with equipment can be replaced by others with the diameter of 6 inches. This caster
increases the height of the incubator at 80 mm with the advantage of providing less effort to move the
incubator.
Note: All casters supplied to the incubator SCTI LINE 4 have locks.
Note:
- Optional item.
- 30 -
1.5.39 - DISPOSABLE RN SENSOR (code 2600040050)
It has the same function as the conventional RN sensor but showing the single-use feature. Coated sensor in
biocompatible titanium according to ISO 10993-1.
Figure 59 - Disposable sensor

Note:
- Optional item.
1.5.40 - AUXILIARY TEMPERATURE SENSOR (CODE 2600040040)
Allows the reading of the patient's peripheral temperature or the air temperature. Sensor supplied with
connector P2 on the white color. Coated sensor in biocompatible titanium according to ISO 10993-1.
Figure 60 - Auxiliary sensor

Note:
- Optional item.
1.5.41 - COVER FOR AUTOCLAVABLE MATTRESS (CODE 1450000078)
This cover can be used in place of conventional plastic cover. Displays external finishing of cotton and inner in
waterproof, nontoxic and washable material.
Its use exempt sheets for mattress coating.
The cover for the mattress may be sterilized by autoclaving process at temperatures up to 121°C for 20 min.
Figure 61 - cover for autoclavable mattress

Note:
- Optional item.
1.5.42 - GEL MATTRESS (CODE 2650010349)

Offers greater comfort for patients, including assisting the maintenance of the body temperature.
Figure 62 - Gel mattress

Note:
- Optional item.
- 31 -
1.5.43 - ADAPTER FOR VENT TUBES (CODE 548081121080)
This accessory allows that vent tubes be installed safely and comfortably.
For easy positioning, the tube adapter is composed of a flexible rod, installed inside the newborn
compartment.
Figure 63 - Adapter for vent tubes
Note:
- Optional item.
1.5.44 - TRIPLE RULE SET

This accessory can be attached directly to the oxygen mains or air compressed from hospital and/or
ambulance; it has 3 outlet nozzles with valve.
With the triple rule set are provided two flowmeters, a nebulizer and a vial for aspiration.
A - Inlet Nozzle
B - Register
C - Role output
Note: Connections A and C have thread

9/16" connection - 18UNF when used
for O2 and 3/4" - 16 UNF for
compressed air.
Figure 64 - Triple Rule
Note:
- Optional item.
1.5.45 - NEBULIZER (CODE 5010000014)

The use of this accessory in the transport incubator increases the concentration of air humidity in the inside of
the newborn compartment.
Plastic container with capacity of 300ml, hose with thread 9/16" connection - 18UNF.
1 - Connection for compressed air mains

2 - Water Tank
3 - Connection for incubator dome
Figure 65 - Nebulizer
Note:
- Optional item.
- 32 -
1.5.46 - MANUAL RESUSCITATOR
(Accessory not exclusively for use in the SCTI LINE 4 incubator. It has its own registration with ANVISA No.:
10432300009).
This accessory consists of a self-inflating sphere in autoclavable vinyl, face mask with polycarbonate bowl and
inflatable vinyl cushion, inlet connection for oxygen supply, unidirectional polycarbonate valve with safety
valve. It can be provided in two sizes (1 and 2)

Manual resuscitator kit Size 1 2650010061
Manual resuscitator kit Size 2 2650010611
Figure 66 - Manual resuscitator
Note:
- Optional item.
1.5.47 - HOOD FOR OXYGEN THERAPY

10227180030).
The Hood for Oxygen Therapy is formed by a cylindrical body with a removable cover and built in transparent
acrylic. The use of this accessory is intended to provide comfort and proper oxygen concentration to the
patient.
The oxygen inlet is made through an inlet nozzle of polycarbonate located in the hood body.
A hole located in the cover and other two lateral passages located in the body of the hood prevent the
formation of CO2 in case of oxygen lack.
The hood can be supplied in three different sizes for patients of different body weights:
Note: For use instructions, check the manual accompanying the optional equipment.
Description Size RN Weight Olidef Code
Hood for oxygen therapy Kit Small < 1000g 52060

Hood for oxygen therapy Kit Medium 1000g to 3600g 52061
Hood for oxygen therapy Kit Large > 3600g 52062
1 - Cover Hole
2 - Cover
3 - Oxygen Inlet Nozzle for hose of
1/4"
4 - Hood Body
5 - Side Passage
Figure 67 - Hood
Note:
- Optional item.
- 33 -
1.5.48 - HALOGEN PHOTOTHERAPY
10227180020).
The Halogen Maxiphoto Phototherapy acts in the hyperbilirubinemia treatment emitting light in the spectrum of
primary radiation in the range between 400nm and 550nm. In this process, the light emitted by the
phototherapy decompose bilirubin into soluble water compounds absorbable by the patient. The light emitted
by the Halogen Maxiphoto is generated by a halogen lamp and the reflector filters ultraviolet and infrared
radiation and directs the light focus to the patient.
The use of this accessory allows the incubator to work with the Halogen Maxiphoto phototherapy coupled to
the column of the support display as shown in Figure 68.
Note: For use instructions, check the manual accompanying the optional equipment.
Figure 68 - Incubator with Coupled Halogen phototherapy

Note:
- Optional item.
1.5.49 - DISINFECTION TANK

This device facilitates the cleaning and disinfection process of the control module allowing the immersion of
sensor, heating resistance and fan without risk to the electronic compounds. For details of use, see item 8.1-
Cleaning of this manual.
Figure 69 - Disinfection tank

Note:
- Optional item.
CONSUMABLE MATERIAL
1.5.50 - AIR FILTER
(Consumable material exclusively for use in the SCTI LINE 4 incubator)
The Newborn Incubator model: SCTI LINE 4 has an air filter whose function is to remove impurities from the
air being introduced into the newborn compartment.
This filter should be replaced at periods shorter than 90 days or whenever the incubator receives a patient with
infectious disease. The filters are exclusively for use in the SCTI LINE 4 incubator.
To ensure the perfect operation and an ideal environmental condition for the patient, use only original Olidef
air filters.
The filters are available in packages with 2 or 10 units.
See item 7.2.1 - Replacement of air filter.
Air filter kit with 2 units 5010000017
Air filter kit with 10 units 5010000026
Note:
- Optional item.
- 34 -
1.5.51 - ADHESIVES FOR OXYMETRY SENSOR
To use the oxymetry sensor two different types of disposable adhesives for fixation are available providing
comfort and the correct positioning of the sensor in the patient.
The adhesives are supplied in kits with 25 units in two patterns for newborns of different weights:

Adhesives kit for oxymetry sensor Size 1 1600 000030
Adhesives kit for oxymetry sensor Size 2 1600 000035
Figure 70 - Adhesive Size 1 Figure 71 - Adhesive Size 2
Note: It is recommended the use of adhesives size 1 for patients up to 2 kg and adhesives size 2 for patients between 2 and 10 kg
Note:
- Optional item.
1.5.52 - ADHESIVES FOR RN SENSOR (CODE 548051121080)

Such adhesives must be used for fixation of the temperature sensor on the patient's skin and are supplied in
kits of 10 units.
Note:
- Optional item.
1.5.53 - EYE SHIELD FOR PHOTOTHERAPY

(Consumable material not exclusively for use in the SCTI LINE 4 incubator. It has its own registration with
ANVISA No.: 80358749005).
This disposable device is used to protect the newborn eyes during the use of phototherapy. To facilitate its use
in patients of different weights, the protector has adjustable size via velcro system and a choice of three
different sizes. It is made with hypoallergenic materials.
The eye shield should be replaced every patient exchange

Eye shield kit for phototherapy - size P 2650010350
Eye shield kit for phototherapy - size M 2650010351
Eye shield kit for phototherapy - size G 2650010353
Figure 72 - Eye shield
CAUTION
- Validity: 5 years
Note:
- Optional item.
- 35 -
1.6 - TECHNICAL SPECIFICATIONS
Note:
- Olidef has a continuous improvement policy for its products and reserves the right to change technical
specifications without notice.
Classification according to ANVISA

Technical Name Neonatal Incubator
Trade Name Newborn Incubator
Trade Model SCTI LINE 4
Framing Class Classe III (high risk)
ANVISA Register 10227180028
Technical Responsible Clayton André dos Santos - CREA: 5061591003/SP
Classifications and the Equipment features

Insulation Class Class I
Applied Part Type BF
Protection against Water Penetration Common Equipment - IPX0
Operation Mode Continuous
Protection against Explosion Not suitable for use in the presence of flammable anesthetics
Washable with non-toxic PVC coating (based on biocompatibility
Mattress
tests).
Mechanical stability Limited to 10° tilt
CO2 concentration less than 0.2%
Air velocity over the mattress less than 0.35m/s
Internal noise in the Dome (environment
less than 50 dBA
<45dBA)
Note: Classification and features according to NBR IEC 60601-1 and NBR IEC 60601-2-19.
Electrical Specifications
Power Supply Automatic selection of voltage
Voltage 127/220V~ ±10%
MC1 2,7A
Current (127/220V)
MC2 and MC3 9,5 A
Mains frequency 50 / 60Hz
MC1 3A
Incubator fuse (127/220 V)
MC2 and MC3 10 A
MC1 380 A
Inlet power
MC2 and MC3 1200 A
Output Power (Auxiliary outlets) 180 W (each)
Tubular electrical resistance in stainless steel.
Heater element - Air
Rated power: 250 W
Tubular electrical resistance in stainless steel.
Heater element - Humidity
Rated power: 250 W
Rechargeable Battery 8,4V
Mechanical Specifications - Incubator with Conventional Support

Height* 1400 mm
Width 900 mm
Depth 540 mm
Mattress height level 1020 mm
Dome Dimensions 832 X 480 X 388 mm
Dome Volume 144 L
Mattress Dimensions 315 X 580 mm
Internal Height of Mattress w/ Dome 350 mm
Passage Height of Mattress x Access 200 mm
Maximum Tilt of Bed (Trendelenburg and Reverse) 12°
Approximate weight without accessories 65 kg
Approximate weight with accessories 75 kg
Caster of 4" w/Brake (Optional 5" and 6" w/Brake) 4 units
Packed weight without accessories 113 kg
*The height with optional caster of 5" increases the height in 22mm, and with 6" increases 80 mm.
- 36 -
Mechanical Specifications - Incubator with Support w/ Height Set
Support height at maximum position 1540 mm
Support height at minimum position* 1340 mm
Width 900 mm
Depth 540 mm
Level height of Mattress at maximum position 1210 mm
Level height of Mattress at minimum position 1010 mm
Approximate weight without accessories 80 kg
Approximate weight with accessories 90 kg
Caster of 4" w/Brake (Optional 5" and 6" w/Brake) 4 units
Packed weight without accessories 128 kg
*The height with optional caster of 5" increases the height in 22mm, and with 6" increases 80 mm.
Technical Specification - Temperature:

Display Resolution 0,1°C
Control range for AR mode (ATC) 20,0 to 39,0°C
Indication Accuracy of AR Temperature ± 0,3°C
Control range for RN mode (ITC) 35,0 to 38,0°C
Indication Accuracy of RN Temperature ± 0,2°C
Approximated time of heating to increase the
40 minutes
temperature from 25°C to 36°C
Temperature indication 0 to 50°C
* Environment temperature between 21°C - 25°C
Technical Specification - Oxygen:

Display Resolution 1%
Operation range of O2 display 0 to 99,9 %
Control Range of O2 (servo controlled) 21 – 65 %
O2 Control Accuracy (calibrated at 21%) ±5%
Calibration pressure 525 to 938 mmHg
Temperature range for sensors operation 10 to 40ºC
Maximum flow of O2 inlet pressure (3.5 kgf/cm²) 64 lpm
Inlet Nipple (servo controlled) 9/16" Thread - 18 UNF
Operating pressure (servo-controlled) 3,5 Kgf/cm² (49,78 PSI)
Technical Specification - Humidity:
Display Resolution 1%
Performance range of humidity display 20 to 100 %
Humidity Control Range 20 – 95 %
Humidity Accuracy Control ± 5%
Temperature range for sensor operation 10 to 40ºC
Tank Volume 3000 ml
Operation Time* 30h – 80%
* Environment Temperature 23°C, Relative Humidity between 40 to 60% and Control Temperature Mode AR 34ºC.
Technical Specifications - Oxymetry:

Display Resolution - SpO2 1%
Display Resolution - Pulse 1
Reading range of SpO2 0 to 100 %
Reading accuracy of SpO2 70 to 95% ±3 digits (Arms*)
Reading range of Pulse 20 to 250 bpm
Reading accuracy of Pulse ±3 digits
* Arms encompass 68% of population.
Technical Specifications - Balance:

Display Resolution 1g
Reading range 0 to 10Kg
Indication Accuracy ± 5g
Maximum load
Serum Support 1 kg (per hook)
Bed 10 kg
Auxiliary Shelves 10 kg
Balance 10 kg
- 37 -
1.6.1 - SYMBOLS USED IN EQUIPMENT
Read and understand the meaning of these symbols before using SCTI LINE 4 Incubator.
On/Off (for one equipment part only)
Trend graph key
BPM key
AR mode key
RN mode key
Relative humidity key
Balance mode key
Grounding terminal for protection
General grounding terminal including functional
Hot Surface
Proportional heating indicator
Applied part Type BF
CAUTION! Consult accompanying documents
O2 concentration key
SpO2 key
Silent alarm
Key to turn off the alarm sound (See ALARMS item)
Alarm indicator
Off (no electrical power supply)
On (no electrical power supply)
- 38 -
Increase of desired range
Reduction of desired range
Auxiliary lighting
Key that enables selection of a temperature higher than 37.0°C
Key that enables / disables the key lock
Operating Mode Key
2 - SPECIAL CONDITIONS OF STORAGE, PRESERVATION AND/OR

HANDLING OF PRODUCT:
2.1 - BEFORE INSTALLATION:
Mark on the packaging of incubator and support:
Information on precautions to be taken during transport and storage of product are indicated by standardized
symbology directly on the packaging.
Note:
- Both conventional support, support system with height set and detachable support accompanies the product
in a separate packaged.
Fragile - care in transport and storage.
Protect against rain in transport and storage.
Handle the packaging with the side indicated by the arrows up.
Maximum Stacking - determines the maximum quantity of boxes can be stacked during
transport and storage.
Maximum humidity 80%.
- 39 -
Determines the temperature limit, among which, the packaging should be stored or
transported.
Keep away from sunlight.
2.2 - AFTER INSTALLATION:

Environmental conditions for operation:
Operating temperature range 22ºC to 25ºC
Operating Relative Humidity 15 to 35% non-condensing
Environment noise < 45 dB
Atmospheric pressure 525 mmHg to 795mmHg
Environmental Conditions for packaging (between operations):

• In a location protected from rain and direct sun
Environment temperature range for packaging 0 – 55ºC
Environment relative humidity range for packaging 0 – 80% non-condensing
Atmospheric pressure range 525 mmHg to 795mmHg
Preservation
• When using, for cleaning and disinfection of equipment surfaces use mild soap only.
• Keep the equipment clean and disinfected for the next use.
• Do not allow liquids to be stored inside the equipment.
• Do not use caustic or polishing detergent or ultrasonic cleaners, as well as organic solvents as thinner
to clean the equipment.
• Keep the equipment in a clean place, away from dust
3 - WARNINGS AND/OR PRECAUTIONS TO BE TAKEN

This chapter contains extremely important information to ensure the safety and integrity of the patient, the user
and the equipment. Read with CAUTION!
• Newborn Incubator - SCTI LINE 4 model should be used by properly trained personnel only under the
guidance of a qualified physician familiarized with the risks and known benefits of its use.
• All equipment users should be familiarized with the neonatal incubator operation and effects caused to the
patients.
• This incubator is not suitable for use in the presence of flammable anesthetic gases or other flammable
materials as some cleaning fluids.
• Before connecting the equipment, make sure the power supply is continuous, if the grounding is reliable
and whether the facilities are suitable for hospital use.
• Use a voltage regulator if there is the possibility of fluctuations in the electrical mains above the range given
in technical specification item.
• Use only original power cable. Do not use adapters, multiple outlets, additional extensions or cables that
are not supplied by the manufacturer or its authorized representatives.
Do not use the incubator without the net grounding properly connected.
• Do not exceed the maximum power value specified in the Auxiliary Outlet accessory, as may be electrically
overloading the set.
• Before connecting any additional equipment to the patient, make sure that it is electrically safe.
• Do not connect any item that is not specified as part of the equipment.
• There is a risk of electric shock in the inner parts of the equipment; make sure that revisions, calibrations
and maintenance are performed by qualified personnel only.
• High frequency surgical equipment, electrical stimulators, short wave therapy, defibrillators and cardiac
pacemakers may affect the incubator operation despite having the same protection filters that meet the
specifications of electromagnetic compatibility standards.
• The incubator is not recommended for use with high frequency surgical equipment.
- 40 -
• The sensors used by the incubator are not protected against the effects of defibrillation; so, before
you start monitoring a physiological parameter, observe the information, warnings and precautions on the
implementation and the operation mode of accessories in order to avoid the incorrect use, once it may cause
burns and/or electric shocks in an eventual defibrillator discharge.
• Never place objects near the air inlet or output of the RN compartment.
• The use of child safety seats or other accessories inside the incubator can change the air flow standard
and may affect the temperature uniformity of the temperature variation, remained correlation of temperature
from the incubator related to the mattress core temperature and the newborn skin temperature.
• Equipment used in conjunction with the incubator, such as phototherapy or heated mattresses, can affect
the equipment performance changing the distribution of heat on the mattress, affecting the air and patient's
skin temperature.
• To prevent the increase of the patient temperature due to direct radiation, do not position the incubator
where there is direct sunlight or other radiant heat source. In these cases, the operation by the temperature
control by RA mode may be compromised.
• Lock the incubator casters before handling the control panel or when in use.
• For the best incubator stability, always lock the casters when at rest.
• When the incubator is stopped on a ramp, make sure the casters are locked and there is no risk of slipping.
• When moving the incubator using the height set support, always maintain a minimum height adjusted in
order to improve the set stability.
• Do not carry the incubator with the trays loaded.
• Before placing any load on the support for incubator monitors, make sure it is locked, if the load is fully
supported in the tray, it is recommended to stay on top of tabs and/or overlap other equipment, and always
seek to place in the tray center.
• Do not exceed the maximum loads specified in this guide.
• Use of this equipment is restricted to a patient at a time.
• It is not advisable to leave the newborn unattended when the access ports are open.
• Do not leave the patient unattended on the mattress if any alarm is activated.
• It is essential monitoring of the incubator operator independently of the newborn temperature.
• The incubator cannot distinguish between an increase in the inner body temperature with a cold skin (fever)
and a low inner body temperature (hypothermia). It is recommended to monitor the temperature of the patient.
• The incubator cannot measure or control the patient's skin temperature if the RN sensor is not correctly
placed on the patient.
• Check regularly if the RN sensor and adhesive for fixation are properly placed in the patient. Check
regularly if the RN sensor and adhesive for fixation are properly placed in the patient. Ensure that the RN
sensor is always in direct contact with the baby's skin.
• Rectal temperatures are not suitable for controlling the heater output from the incubator.
• The sensors' module and/or RN sensor should always be connected to the control module.
• Never leave the dome access port open more than necessary because the incubator may not accurately
reflect the temperature shown on the panel.
• Check if the RN sensor cables, balance and other extender tubes are correctly placed in tube passages or
if the iris sleeve is correctly installed, otherwise the temperature stability of the incubator may be interfered.
• Use RN sensors supplied directly by Olidef only or the authorized representatives.
• Regularly inspect the locks of the dome covers, portholes and mattress bed as there may be risk of falling
of the newborn.
• To avoid possible injury to the patient not to increase the dome while the tubes are connected to it and/or
the bed is tilted in Trendelenburg or High Horizontal position.
• Before lifting the dome make sure all tubes and cables are disconnected from the control module.
• When lowering the dome make sure the newborn body and limbs are all within the limits of the mattress.
• Only qualified personnel should perform maintenance procedures and equipment calibration.
• Do not touch the metal surfaces of the heater.
• To avoid the possibility of burns while maintenance and cleaning procedures are being performed, make
sure that the incubator is disconnected from the electrical mains and check if the heater is not hot.
• To avoid risk of electric shock while performing the cleaning and maintenance procedures, disconnect the
equipment from electrical mains and disconnect the general key.
• Check if the oxygen and compressed air supply for the incubator transport are closed before procedures of
cleaning and maintenance. There is a risk of fire and explosion if the maintenance or cleaning of the incubator
is performed in an environment enriched with oxygen.
• Disconnect the RN sensor of the control module pulling it from the connector. Do not apply excessive force
to the sensor cable during use or cleaning and inspection procedures.
• Do not remove the RN sensor from the patient pulling the cable with excessive force. Such a procedure
can damage the RN sensor or irritate the patient skin.
- 41 -
• Disconnect the sensor module in the incubator dome by pulling the existing tab. Do not apply excessive
force to the sensor cable during use or cleaning and inspection procedures.
• Do not use solvents or abrasive cleaning solutions to clean the surfaces of the incubator. The use of
alcohol on acrylic surfaces can cause it to dry out, leaving it opaque.
• Do not expose the plastic and acrylic surfaces to direct radiation from germicidal lamps. The ultraviolet
radiation from these sources can cause drying of these materials.
• Before applying chemicals for cleaning the incubator surfaces, make sure they are not aggressive to
plastic, acrylic, chrome or painted parts. In case of doubt, consult your supplier.
• Disconnect and hold off the oxygen supply during cleaning procedures of the incubator.
• When X-rays are taken through the dome, the acrylic dome may show up on the image as a radiolucent
shadow, and may result in an incorrect diagnosis.
• Do not place equipment or other accessories on the dome. During an emergency it can be quickly opened.
• Use original Olidef spare parts and accessories only to ensure best performance and safety of the
equipment.
• It is not allowed to modify the product, under any conditions. Any disassembly or change will cause the
guarantee invalidity.
3.1 - OXYGEN
• The incorrect use of supplemental oxygen may be associated with serious side effects including blindness,
brain cell damage and death. The risk varies with each patient. The method, concentration and oxygen
administration time should be prescribed by a qualified physician aware of risks and benefits.
• If you need to administer oxygen in an emergency, the attending physician should be notified immediately.
• The oxygen flow rates marked on the incubator, flow of oxygen released by the flow meter and the
percentages shown on the display of the control module panel should not be used as an indication of correct
oxygen concentration in the incubator, and should only be used as a guide. Oxygen concentrations must be
measured with an oxygen analyzer calibrated at regular intervals defined by the attending physician.
• The rate of oxygen flow marked in the table on the left side is not valid when working in a Servo controlled
mode of Oxygen.
• Opening the access port, it may occur a decrease in the oxygen concentration. To make a new
measurement, wait a while so the concentration is restored.
• The oxygen concentration inhaled by a child does not determine the partial oxygen pressure in advance in
the blood.
• Do not use oxygen in the presence of flammable anesthetics.
• Keep all ignition sources (e.g., matches, cigarettes, sparking equipment, etc.) away from the room where
the incubator is operating. Fabrics, oils or other fuels ignite easily when the air is enriched with oxygen.
• Dirt on the air filter can affect the oxygen concentration in the incubator and/or cause the formation of
carbon dioxide (CO2). Make sure the filter is clean and/or is being exchanged within the time specified, or
whenever necessary.
• The risk of retrolental fibroplasia incidence is incremented when applying oxygen concentrations greater
than 40% in newborn with cardiorespiratory disease.
• Do not connect the oxygen hoses in both oxygen inlet nipples at the same time.
• Use oxygen sensors supplied directly by Olidef only or the authorized representatives only.
3.2 - INTEGRATED OXYMETRY

• The maximum and minimum limits of SPO2 parameters alarm and heart rate should be determined by the
attending physician.
• Improper set of these alarms may result in the absence of alerts in situations of potential risk to the patient.
• Inaccurate values may be caused by incorrect implementation of sensor, environment lighting, sensor
placement and patient movement.
• Loss of pulse frequency may be caused due to the sensor being too tight or arterial occlusion near the
sensor.
• A strong lighting of the environment, sun lighting, surgical lamps or phototherapy can interfere with the
performance of a SPO2 sensor; in these cases, cover the sensor area with an opaque material.
• Inspect the sensor application site at least every 6-8 hours to ensure the correct alignment of the sensor.
• The maximum time recommended for application of oxymetry sensor in the same location is 8 hours. The
sensitivity of the patient to the sensors may vary, and thus, inspect the application site regularly to ensure the
skin integrity.
• Discontinue the use if the patient presents allergic reactions to the adhesive material.
• Use sensors supplied and adhesives directly by Olidef or the authorized representatives only.
- 42 -
4 - PERFORMANCES ON ESSENTIAL SAFETY REQUIREMENTS AND
EFFICACY OF MEDICAL PRODUCT
4.1 - INDICATION, PURPOSE OR USE THAT THE PRODUCT IS INTENDED
Indication: Clinics, medical units, hospitals and maternity units that need to provide ideal thermal comfort for
newborns, and especially premature and newborns at risk, offering propitiate environmental conditions to
those presenting disorders in the neonatal period or commitment of body thermo-regulation.
Purpose: Maintain a human newborn allowing its viewing through a dome with transparent acrylic and double
wall. Inside the newborn compartment, environmental conditions can be maintained as per the RN needs by
maintaining the air heating, increasing of oxygen concentration and relative humidity beyond soundproofing
and low level of noise produced by the equipment. In addition, the product allows monitoring of heart rate /
SPO2 of such patients.
4.2 - SAFETY AND EFFICACY OF PRODUCT:
The SCTI LINE 4 incubator is totally safe as long as safety rules are followed and all recommendations
described in this User Guide.
The equipment is designed and manufactured with standard materials (nontoxic) for medical/hospital use and
allow easy disinfection. It is practical and designed to ensure complete safety
When kept (stored) and maintained as mentioned in item 2 - Special conditions of storage, preservation and /
or handling of the product of this guide, the equipment will not lose or change the physical and dimensional
features.
The Newborn Incubator model: SCTI LINE 4 was designed, evaluated and meets the following safety and
performance standards:
NBR IEC 60601-1 NBR IEC 60601-2-49 IEC 61000-3-3 IEC 61000-4-5
NBR IEC 60601-1-1 NBR ISO 9919 IEC 61000-4-2 IEC 61000-4-6
NBR IEC 60601-1-2 CISPR 11 IEC 61000-4-3 IEC 61000-4-8
NBR IEC 60601-2-19 IEC 61000-3-2 IEC 61000-4-4 IEC 61000-4-11
CAUTION
- Electric-medical equipment requires special precautions regarding EMC (electromagnetic
compatibility) and must be installed and put into service according to the EMC information
provided in this guide. This incubator does not emit electromagnetic interference above the level
compatible with its category, and also presents certain immunity to electromagnetic interference
around it. General standards and electromagnetic compatibility tests for neonatal incubators
have been applied to this equipment and determined the environment and precautions to be
taken for its installation and subsequent operation, see the tables below:
- 43 -
Guidance and Manufacturer's Statements - Electromagnetic Emission
The SCTI LINE 4 model is designed for use in electromagnetic environment specified below. The customer or the user
of such model must ensure that the unit is used in such environment.
Emission Test Accordance Electromagnetic Environment - Guide

The SCTI Line 4 Incubator uses RF power for
Radio frequency emission (RF) its internal function only. Therefore, its RF
Group 1
ABNT NBR CISPR 11 emissions are very low and not likely to cause any
interference nearby electronic equipment.
Radio frequency emission (RF) The SCTI LINE 4 Incubator is suitable for use
Class A
ABNT NBR CISPR 11 in all establishments other than households and
Harmonics Emission those directly connected to the public power supply
Class A
IEC 61000-3-2 of low voltage that feeds the buildings used as
residences.
Warning: This equipment can be used in
residential establishments and those directly
Voltage Fluctuations / Flicker connected to the public power supply of low
Emissions According voltage that feeds the buildings used as residences
IEC 61000-3-3 since handled by health professionals and aware
that this product may cause radio interference or
disrupt operation of the equipment nearby. You
may need relocation or shield the incubator's site.
Separation distances recommended between communication equipment of handle and mobile RF and the
SCTI LINE 4 Incubator
The Incubator is designed for use in an electromagnetic environment in which RF disturbances are controlled. The
Incubator customer or user can help prevent electromagnetic interference by maintaining a minimum distance
between the RF communication equipment (transmitters) and the handle and mobile incubator as recommended
below, according to the maximum output power of the communication equipment.
Nominal Maximum Separation Distance Recommended According to Transmitter Frequency (m)
Power of the 150 kHz to 80 mHz 150 kHz to 80 mHz in
Transmitter Output 80 MHz to 800 MHz 800 MHz to 2,5 GHz
out of ISM bands ISM bands
0,01 0,12 0,12 0,12 0,23
0,1 0,38 0,38 0,38 0,73
1 1,2 1,2 1,2 2,3
10 3,8 3,8 3,8 7,3
100 12 12 12 23
For transmitters with maximum power rate of output not listed above, the recommended d separation distance in
meters (m) can be determined using the equation applicable to the transmitter frequency, where P is the maximum
power rate of output of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, applies the separation distance for the higher frequency range.
NOTE 2: The ISM band (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
NOTE 3: An additional factor of 10/3 is used in the calculation of recommended separation distance for transmitters in
the ISM bands between 150 kHz and 80 MHz and frequency range from 80 MHz to 2.5 GHz to decrease the likelihood
of mobile/handle communication equipment to cause interference if it is inadvertently brought into patient areas.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
- 44 -
Guidance and Manufacturer's Statements - Electromagnetic Immunity
The SCTI LINE 4 Incubator is intended for use in the electromagnetic environment specified below.It is
recommended that the buyer or user of Incubator ensures that it is used in such environment
Trial Level of IEC Accordance
IMMUNITY Trial Electromagnetic Environment - Guidance
60601 Level
It is not convenient that communication
equipment per mobile or portable RF be used at
distances smaller in relation to any part of the
incubator, including cables, than the separation
distance recommended calculated from the
equation applicable to the transmitter frequency.
Separation distance recommended
Conducted RF 10 Vrms 10 Vrms d=1,2 P1/2

IEC 61000-4-6 150 kHz to 80 mHz
in ISMa bands
Irradiated RF 10 V/m d=1,2 P1/2 80 MHz a 800 MHz
IEC 61000-4-3 80 MHz to 2,5 GHz d=2,3 P 1/2 800 MHz a 2,5 GHz
Where P is the maximum level declared of output

power of transmitter in watts (W) according to the
manufacturer's transmitter and d is the separation
distance recommended in meters (m).b
It is important that the field intensity from the RF

transmitters determined by an electromagnetic
inspection of the field, c is smaller than the
compliance level for each band frequency.d
Interference may occur in the surroundings of

equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a:
The ISM band (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150KHz and 80MHz and frequency range between
80MHz up to 2.5 GHz is intended to reduce the probability of mobile and portable communication equipment to
cause interference if inadvertently brought to the patient's environment. For this reason, an additional factor of
10/3 is used in distance calculation of recommended separation for transmitters in these frequency ranges.
c
Field intensity established by fixed transmitters, such as base stations, telephone (mobile/cordless) and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy..
To assess the electromagnetic environment due to fixed RF transmitters, it is recommended to consider an
electromagnetic inspection in the site. If the measure of the field intensity in the site which the SCTI LINE 4
Incubator is used exceeds the applicable RF compliance level applied above, it is recommended to observe the
incubator in order to check whether the operation is normal. If abnormal performance is observed, additional
procedures may be necessary, such as reguidance or replacement of the Incubator.
d
Over the frequency range of 150 kHz to 80 MHz, the field resistance should be less than 1 V/m.
- 45 -
Guidance and Manufacturer's Statements - Electromagnetic Immunity
The SCTI LINE 4 Incubator is intended for use in the electromagnetic environment specified below. It is recommended
that the buyer or user of Incubator ensures that it is used in such environment.
Electromagnetic
IMMUNITY Trial Trial Level of IEC 60601 Accordance Level
Environment - Guidance
Electrostatic Discharge ± 6 kV contact ± 6 kV contact It is important that floors
(ESD) should be wood, concrete or
ceramic. If floors are covered
± 8 kV air ± 8 kV air with synthetic material, the
IEC 61000-4-2 relative humidity should be at
least 30%.
Fast/Save Electrical ± 2 kV for power supply ± 2 kV for power supply
It is important that quality of
Transient lines lines
the mains supply be typical
of a commercial or hospital
± 1 kV for inlet/output ± 1 kV for inlet/output
environment.
IEC 61000-4-4 lines lines
Outbreaks ± 1 kV line(s) to line(s) ± 1 kV differential mode It is important that quality of
the mains supply be typical
of a commercial or hospital
IEC 61000-4-5 ± 2 kV line(s) to land ± 2 kV common mode environment.
Voltage breaks, short < 5% UT < 5% UT It is important that quality of
interruptions and voltage (break > 95% in UT) (break > 95% in UT) the mains supply be typical
variations on the inlet lines per 0,5 cycle per 0,5 cycle of a commercial or hospital
of power supply environment. If the user
40% UT 40% UT needs the Incubator
IEC 61000-4-11 (break > 60% in UT) (break > 60% in UT) continued operation during
per 5 cycles per 5 cycles interruptions of mains supply,
it is recommended that the
70% UT 70% UT incubator is powered by an
(break > 30% in UT) (break > 30% in UT) uninterrupted source or
per 25 cycles per 25 cycles battery.
< 5% UT < 5% UT
(break > 95% in UT) (break > 95% in UT)
per 5 s per 5 s
Magnetic field generated by 3 A/m 3 A/m If distortion occurs, it may be
the mains frequency (50/60 necessary to position the
Hz) incubator further of magnetic
IEC 61000-4-8 field sources in the mains
frequency of power supply or
install a magnetic shield. It is
important that the magnetic
field in the mains frequency
of power supply be
measured in the site for
installation to ensure that it is
sufficiently low.
NOTE - UT is the a.c. mains voltage prior to application of the test level.
5 - USE WITH OTHER EQUIPMENT

The Newborn Incubator model: SCTI LINE 4 can be used with other equipment, such as: lung fan, oximeter,
oxygen monitor, multiparameter monitor, infusion pump, radiometer, phototherapy and x-ray device.
Equipment weighing up to 10 kg can be placed directly on the support for monitors. Do not transport the
incubator with any type of equipment or packed load in the support for monitors.
Such equipment must be positioned securely to prevent fall or accidental displacement when using the
incubator. Use the existing straps to lock the equipment.
To use the sensors, use the cable passages located on the side of the incubator.
To use tubes for lung ventilation, use the passage on the left side of the dome. This device allows the passage
of tubes up to 2 inches without loss of heat inside the newborn compartment.
CAUTION
- The equipment that used with the Incubator for Newborn model: SCTI LINE 4 must have CE
certification and meet the existing harmonized standards for electromagnetic compatibility and
electrical safety. The equipment that does not meet these requirements will be subject to receive
or to issue an electromagnetic interference and may cause change of reading parameters of
failure in heating control and starting of security alarms, and also increase the possibility of
electrical failures.
- 46 -
6 - INSTALLATION AND OPERATION
6.1 - INSTALLATION OF EQUIPMENT
6.1.1 - UNPACKING
When you receive your SCTI LINE 4 incubator should have the following cares:
• Make sure the box containing the equipment shows the impact or perforation signs, then the report should
be subject to immediate claim with the carrier, and is recommended to call an authorized representative
for joint assessment of any damage caused to the equipment;
• However, regardless the presence or absence of external signals (on the package), if found any
irregularities occurred during transportation, the procedure should be the same as mentioned in the
previous item;
• Before using the equipment, fill out the warranty certificate that accompanies it, and send it to Olidef.
• Making it necessary to store the equipment, it shall be provided a place where the environmental
conditions are suitable, the temperature should not exceed 55ºC and the relative humidity should be below
80% non-condensing. It is recommended that the unit be stored in its original package.
6.1.2 - PRELIMINARY CHECKING

After unpacking your SCTI LINE 4 incubator, do the following checks:
• General mechanical state of the equipment
• General conditions of painting
• General state of acrylic dome
• Operation of port for intensive care and portholes
• Conference of accessories that come with the device (1 AC power cord, 1 set of filters (with 2 units), RN
sensor, user guide, 2 fuses and optional requested) as well as the inclusion of the Authorized Agents
Ratio to provide technical assistance to this equipment and Warranty Certificate.
6.1.3 - ASSEMBLY OF EQUIPMENT

The SCTI LINE 4 incubator leaves the manufacturer in special package.
Installation Procedure:
1. Place the support of the incubator on a flat surface. Lock the four casters of transportation support.
2. Place the incubator (1) on the support (2) as shown in Figure 73.
Figure 73 - Mounting Scheme
3. Connect the AC power cord (supplied with the unit) in the plug of control module located on the right side
of the incubator.
4. Connect the power cord into a 3-way hospital outlet with supply voltage of 127/220 V~.
CAUTION
- Do not connect the Incubator if the hospital outlet does not have a reliable grounding. Check if
the voltage and mains current which is being linked to the incubator correspond to the
specifications on the nameplate of the device (located on the back, next to the air filter).
- 47 -
5. Turn on the main switch located on the control module on the right side of the incubator.
6. Remove the RN sensor from the package. Connect it to the control module located on the right side of the
incubator, as Figure 74 and pass the sensor by the tube passages supporting it on the mattress. If the control
module is the MC2 or MC3, connect the sensor in the sensor module located in the RN compartment as
figures 75 and 76.
Figure 74 - Installing the RN sensor - MC1 Figure 75 - Installing the RN sensor - MC2
Figure 76 - Installing the RN sensor - MC3
6.1.4 - ASSEMBLY OF EQUIPMENT WITH HEIGHT ADJUSTMENT SUPPORT

(OPTIONAL)
1. Place the support of the incubator on a flat surface. Lock the four casters of transportation support.
2. Connect the (3) terminals from the incubator and the height adjustable support before placement of
the incubator (1) on the support (2), as shown in Figure 67
Figure 77 - Mounting Scheme
- 48 -
3. Connect the AC power cord (supplied with the unit) in the plug of control module located on the right
side of the incubator.
4. Connect the power cord into a 3-way hospital outlet with supply voltage of 127/220 V~.
CAUTION
- Do not connect the Incubator if the hospital outlet does not have a reliable grounding. Check if
the voltage and mains current which is being linked to the incubator correspond to the
specifications on the nameplate of the device (located on the back, next to the air filter).
5. Turn on the main key (4) of support with height adjustment.

6. Turn on the main switch located on the control module on the right side of the incubator.
7. Remove the RN sensor from the package. Connect it to the control module located on the right side of
the incubator, as Figure 78 and pass the sensor by the tube passages supporting it on the mattress. If
the control module is the MC2 or MC3, connect the sensor in the sensor module located in the RN
compartment as figures 79 and 80.
Figure 78 - Installing the RN sensor - MC1 Figure 79 - Installing the RN sensor - MC2
Figure 80 - Installing the RN sensor - MC3
6.1.5 INSTALLATION OF MONITOR SUPPORT (OPTIONAL)

1. Place the monitor support into the right position, aligning all holes as shown in figure 81
2. Using a 5mm hex wrench put the internal hex socket screw (1) with the washer (2) into the hole and
tighten it.
Figure 81 - Installation of monitor support
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3. Do it with the four screws.
4. Place the axis of the monitor support and enter the tube locking the knob, as shown in figure 82.
Figure 82 - Installation of the axis support
6.1.6 INSTALLATION OF SERUM SUPPORT (OPTIONAL)

1. Place the serum support into the right position, aligning all holes.
tighten it as Figure 83.
Figure 83 - Installation of serum support
6.1.7 INSTALLATION OF GREATER SERUM SUPPORT (OPTIONAL)

tighten it.
Figure 84 - Installation of bigger serum support

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4. Place the axis of the monitor support and enter the tube locking the knob, as shown in figure 85.
Figure 85 - Assembly of the axis of the bigger serum support
6.1.8 - INSTALLATION OF AUXILIARY LAMP (OPTIONAL)

1. Connect the terminals (3).
tighten it.
Figure 86 - Installation of auxiliary lamp
6.1.9 - INSTALLATION OF INTEGRATED OXIMETRY (OPTIONAL)

1. The integrated oxymetry system comes installed from the manufacturer, and the user needs only to
connect the sensor cable on the side panel as shown in figure 87.
Figure 87 - Installation of oxymetry
Note: If there is need to extend the length of the sensor cable, OLIDEF provides an extension cable for pulse
oxymetry.
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6.1.10 - INSTALLATION OF INTEGRATED BALANCE (OPTIONAL)
1. After installation of balance plate (B) under the mattress tray (C), which is under the platform (D) put
the mattress (A) Figure 88.
Figure 88 - Installation of balance
2. Connect the cable from the balance plate in the control module on the right side of the incubator and
turn the main key as shown in figure 89.
Figure 89 - Side Panel
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6.1.11 - INSTALLATION OF LC5 BALANCE (OPTIONAL)
1. After installing the balance plate (B) under the mattress tray (C), which is under the platform (D) put
the mattress (A) Figure 90.
Figure 90 - Installation of balance
2. Fit the balance bearing in the balance support located on the support for monitor and press the knob
(A) until locks it securely, as shown in figure 91.
Figure 91 - Fixation of LC5 balance
3. Connect the balance plate cable on the rear panel of the balance and press the power key.
Figure 92 - Module of power LC5 balance
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6.1.12-INSTALLATION OF PHOTOTHERAPY (OPTIONAL)
tighten it.
Figure 93 - Installation of phototherapy

4. Insert the phototherapy axis in the support and lock the knob as shown in figure 94.
Figure 94 - Assembly of phototherapy
5. Connect the power cord to the AC of phototherapy (supplied with the equipment) in the power inlet
plug located at the bottom of the own phototherapy.
6. Connect to a power source.
CAUTION
Check the voltage key which voltage is in the product before connecting the power supply.
6.1.13 - INSTALLATION OF NEBULIZER (OPTIONAL)

In order to use it, put distilled water in the tank (300 ml maximum), fit the nebulizer in the coupler located at the
dome and connect it to the mains or compressed air cylinder available. The nebulizer will immediately begin
the production of small particles with a mist of water.
- 54 -
Figure 95 - Nebulizer coupled in the dome
6.1.14 - INSTALLATION OF AUXILIARY TEMPERATURE SENSOR (OPTIONAL)

1. Connect the auxiliary sensor plug in the sensor module located in the RN compartment as figures 96.
Figure 96 - Installing the auxiliary sensor - MC3
2. Check the reading at the top of the display as shown in figure 97.
Figure 97 - Graphical display - Auxiliary sensor
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6.2 - TURNING ON THE SCTI LINE 4 INCUBATOR - MC1
PANEL
Figure 98 - Panel of control module MC1

1 DISPLAY OF EQUIPMENT ON
2 ON / OFF KEY
3 OPERATING MODE KEY
4 DESIRED TEMPERATURE INCREASE KEY
5 DESIRED TEMPERATURE REDUCTION KEY
6 SILENT ALARM KEY
7 SILENCED ALARM INDICATOR
8 RN TEMPERATURE INDICATOR
9 AIR TEMPERATURE INDICATOR
10 PROPORTIONAL HEATING INDICATOR
11 ALARM INDICATOR
12 LOSS OF AIR CIRCULATION ALARM INDICATOR
13 HYPOTHERMIA ALARM INDICATOR
14 HYPERTHERMIA ALARM INDICATOR
15 SENSOR FAILURE ALARM INDICATOR
16 DESIRED TEMPERATURE > 37°C INDICATOR
17 MODE OF AIR IN THE DOME OPERATION INDICATOR
18 MODE OF NEWBORN OPERATION INDICATOR
19 OVERHEATING ALARM INDICATOR
20 LACK OF ENERGY INDICATOR
21 LOCKED KEYBOARD INDICATOR
22 KEYBOARD LOCK KEY
23 DESIRED TEMPERATURE INDICATOR
24 COLD AIR ALARM INDICATOR
25 HOT AIR ALARM INDICATOR
26 SETTING KEY GREATER THAN 37ºC
Use of Mains
- Connect the power cable of the incubator in a compatible outlet with voltage specified on the equipment.
CAUTION
- SCTI LINE 4 Incubator can be connected to mains automatic 127/220 V~, frequency 50/60 Hz
- Turn on the main key located on the control module on the right side of the incubator.
- Press the ON key located on the control panel.
6.2.1 - USE OF AR MODE

AR control mode provides a stable control of the air temperature in the newborn compartment through the
automatic activation of heating resistance as desired temperature programmed by the operator. In this
operation mode, the incubator has High and Low Temperature alarms which will be activated when the
temperature is checked for AR with a difference greater than 3.0ºC related to the desired temperature. The
desired value for the air temperature can be set within the range of 20 to 37°C in increments of 0.1°C. The
actual value and the desired value will be indicated on the control panel. How to use the AR mode:
- Turn on the incubator model SCTI LINE 4.
- The equipment comes with set point manufacturer programmed to 34°C. Whenever the equipment is turned
off, the value programmed restarting the AR operation mode will be manufacturer-programmed.
- 56 -
- To set the desired value for the AR temperature, press the DESIRED TEMPERATURE
INCREASE/DESIRED TEMPERATURE REDUCTION until the desired value by the operator.
Figure 99 - Set point of AR temperature
The SCTI LINE 4 Incubator allows the operator to program temperatures above 37ºC. To program high values
(above 37ºC):
- Elevate the temperature to reach 37°C with more than one touch and will be issued 2 beeps and then AR
LEDs IN THE DOME AND NEWBORN will start flashing intermittently.
-
Press the OPERATION MODE to enable a set point between 37.1ºC to 39ºC, the LED > 37ºC will light
indicating that the > 37°C range is enabled as shown in Figure 100.
Figure 100 - LED indicator key "> 37°C" activated
- To set the desired value for the AR temperature (above 37ºC), press the DESIRED TEMPERATURE
INCREASE/DESIRED TEMPERATURE REDUCTION keys until the desired value by the operator.
Figure 101 - Set point of AR temperature above 37ºC
- 57 -
Notes:
- Within the AR field, the number shown is the current value read. The number indicated in the DESIRED
TEMPERATURE field represents the programmed value (set point).
- The incubator will automatically control the power of the heating resistance to stabilize the incubator
temperature as the programmed temperature set by the user.
- On the panel there is a proportional indicator of heating as Figure 101.
6.2.2 - USE OF RN MODE

In the RN mode, the incubator provides the heat necessary for the patient to stabilize his body temperature
through automatic activation of the heater according to the value set by the operator. In this operation mode,
the incubator has HYPERTHERMIA and HYPOTHERMIA alarms which will be activated when the
temperature checked for RN has a difference greater than 1.0ºC related to the desired temperature. The
desired value for the RN temperature can be set within the range of 35 to 37°C in increments of 0.1°C. The
actual value and the desired value will be indicated on the control panel. How to use the RN mode:
- Check if the RN sensor is connected.
- Wash carefully and dry the patient's skin where the sensor will be fixed (on the abdomen or back, if the child
is lying on the stomach).
- Place the sensor on the abdominal skin of the patient and secure it using a non-allergenic adhesive as
shown in Figure 102.
A. Adhesive for temperature sensor

B. RN sensor
C. RN skin
Figure 102 - Scheme for fixing the RN sensor

- To set the desired value for the RN temperature, press the OPERATION MODE key so the incubator may go
to the RN mode.
- The equipment comes with set point manufacturer-programmed to 36.1°C. Whenever the equipment is
turned off, the value programmed restarting the RN operation mode will be manufacturer-programmed.
- To set the desired value for the RN temperature, press the DESIRED TEMPERATURE
Figure 103 - Set point of RN temperature
(above 37ºC):
- Elevate the temperature to reach 37°C with more than one touch and will be issued 2 beeps and then AR
LEDs IN THE DOME AND NEWBORN will start flashing intermittently.
- Press the OPERATION MODE to enable a set point between 37.1ºC to 38ºC, the LED > 37ºC will light
indicating that the > 37°C range is enabled as shown in Figure 104.
- 58 -
Figure 104 - LED indicator key "> 37°C”
- To set the desired value for the RN temperature (above 37ºC), press the DESIRED TEMPERATURE
INCREASE/DESIRED TEMPERATURE REDUCTION keys until the desired value by the operator.
Figure 105 - Set point of RN temperature above 37ºC
Notes:
- Within the RN field, the number shown is the current value read. The number indicated in the DESIRED
- The incubator will automatically control the power of the heater to stabilize the RN temperature as the
programmed temperature set by the user.
- The RN weight, age, medical condition, and other metabolic and environmental factors will affect the time
required for temperature stabilization of the patient related to the programmed temperature.
CAUTION
- The skin sensor should never be used to control rectal temperature because the patient could
receive insufficient or excessive heat.
- The SCTI LINE 4 Incubator cannot measure or monitor the skin temperature of the patient if the
RN sensor is not correctly placed on the patient. The disconnection or failure in the direct sensor
contact with the patient's skin will cause an incorrect reading of temperature, and the incubator
cannot regulate the necessary heat for the patient.
- Use temperature sensors provided only by OLIDEF or its authorized representatives. The use of
different specified sensors may cause errors in the temperature reading and therefore risks to the
patient.
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6.2.3- HUMIDITY CONTROL
Relative passive humidity of air
To increase the humidity concentration in the newborn compartment, fill the incubator tank, set water level.
The maximum tank capacity is about 3 liters. The hot air flow produced by the control panel will pass over the
water surface, causing humidity in the inside of the dome. Replace the water tank daily or every patient
change. The use of water is optional; the equipment can operate normally with no water in the tank.
How to use passive humidity.
- To fill the tank, open the cover (A) and slowly put distilled water until the water level of the tank reaches
among the maximum (B) and minimum (C) level indicated in the plastic cup of the water level set.
Figure 106 - Level of the inside tank for passive humidification
- Turn on the incubator; the hot air flow produced by the control panel will pass over the water surface, causing
humidity in the inside of the dome.
- To drain the water from the tank, open the meter (D) of level indicator, collecting the water in a container.
Note:
- Maximum capacity of the tank is 3L.
CAUTION
- Use distilled or deionized water only.
- The humidity level inside the incubator will depend on the relative humidity of the environment
air.
- When the air temperature inside the incubator is relatively higher than the air temperature, a
condensation may form on the inner walls of the dome. When the difference between the
temperatures is lower, condensation does not appear.
6.2.4 - OXYGEN CONTROL

The SCTI LINE 4 Incubator may administer oxygen in two different ways.
• limiting oxygen valve (inlet to limited 8Lpm)
• passive oxygen valve (optional - inlet limited to 64Lpm)
Note:
- The limiting oxygen valve is a line item if the customer chooses the passive oxygen valve, the composition of
equipment will be as follows:
- Limiting oxygen valve;
- Passive oxygen valve.
CAUTION
- Read and understand the warnings contained in item 3 - Warnings and/or precautions to be taken
adopted in this guide.
- The air inside the newborn compartment should be enriched only with oxygen under prescription.
Operating Mode of Limiting Oxygen Valve

- Turn on the incubator and wait for the stabilization of the inner temperature. If the incubator has to
manage humidification with oxygen application, wait so the air humidity inside the compartment is
stabilized.
- Through a pressure hose with braided nylon 250 PSI nontoxic, connect the flow meter output of mains or a
hospital oxygen cylinder to the oxygen inlet valve nipple from the incubator as Figure 108.
- 60 -
Figure 108 - Connection for operation of limiting oxygen valve
- Install an oxygen monitor, placing the sensor near to the center of the newborn compartment.
- Start the oxygen supply after turning the incubator only to ensure proper mixing of gases within the dome.
- Determine the initial flow of oxygen based on the table located above aside of the relief valve, located on
the right side of the incubator. This table shows approximate values for the oxygen flow required to
maintain the desired concentration. The concentration obtained may vary depending on the relative air
humidity inside the compartment, the state of the air filter, seals of dome, number and frequency of
portholes opening.
- Wait 15 minutes and check the oxygen concentration inside the incubator indicated by O2 monitor without
opening the dome. If necessary, set the oxygen flow through the mains flow meter or cylinders. Repeat O2
concentration reading every 15 minutes.
Note:
- Flows of oxygen above 15 liters per minute will produce oxygen concentrations above the values indicated in
the table.
Inlet Flow (L/min) 0 2 4 6 8 10 12 15
O2 Concentration (%) 21 21 – 28 22 – 32 24 – 34 27 – 40 30 – 42 32 – 44 35 - 50
CAUTION
- Oxygen therapy may increase the noise level for the RN inside the incubator.
- The flow of oxygen cannot be used as an accurate measurement of oxygen concentration inside
the incubator, oxygen concentrations should be measured with a calibrated oxygen analyzer.
- Improper use of supplemental oxygen may be associated to serious side effects including
blindness, brain cell damage and death. The risk varies with each patient. The method,
concentration and duration of oxygen administration should be prescribed by a physician skilled
about risks and benefits.
- If you need to administer oxygen in an emergency, the attending physician should be notified
immediately.
- Oxygen therapy should be done under the supervision of qualified medical personnel only.
- The concentration of oxygen inhaled by a child does not determine in advance the partial oxygen
pressure in the blood.
- Opening of access port may cause a drop in oxygen concentration. To make a new measurement
wait time to restore the concentration.
- Do not use oxygen in the presence of flammable anesthetics.
- Keep all ignition sources (e.g., matches, cigarettes, devices that produce sparks, etc.) away from
the room where the incubator is operating. Fabrics, oil or other fuel ignites easily when the air is
enriched with oxygen.
- 61 -
Operating Mode of Passive Oxygen Valve (Optional)
stabilized.
- Through a pressure hose with braided nylon 250 PSI nontoxic, connect the flow meter output of vehicle
mains or hospital oxygen cylinder to the oxygen inlet valve nipple from the incubator as Figure 109.
Figure 109 - Connection for operation of passive oxygen valve
- Determine the initial flow of oxygen based on the table located above the air filter cover on the rear of the
incubator. This table shows approximate values for the oxygen flow required to maintain the desired
concentration. The concentration obtained may vary depending on the relative air humidity inside the
compartment, the state of the air filter, seals of dome, number and frequency of portholes opening.
Note:
the table.
Inlet Flow (L/min) 0 2 4 6 8 10 12 15
21 – 22 – 24 – 27 – 30 – 32 –
O2 Concentration (%) 21 35 - 50
28 32 34 40 42 44
CAUTION
- Oxygen therapy may increase the noise level for the RN inside the incubator.
immediately.
- Keep all ignition sources (e.g., matches, cigarettes, devices that produce sparks, etc.) away from
- 62 -
6.2.5 LC5 BALANCE (OPTIONAL MODULE)
The SCTI LINE 4 incubator has balance with external panel. The Balance LC5 can be plugged into automatic
mains of 127/220 V ~. The balance has weight limit of 10kg, and accuracy of ± 5g. When this weight is
exceeded the panel will indicate an OVERLOAD message.
How to use the balance.
- Make sure the balance sensor is connected.
- Make sure the balance is energized (4).
- Turn on (1) the LC5 Balance.
- Press TARE (2) key to zero the balance (the patient should not be on the mattress).
- Position the patient on the mattress and wait for the stabilization of the weight indication on the display (3).
Figure 110 - Balance Figure 111 - Panel balance
6.2.6 - ADDITIONAL RESOURCES

6.2.6.1 - LOCK KEY
The panel of the SCTI LINE 4 incubator has a function to lock the keyboard and prevent the programmed
parameters to be changed accidentally. To lock the keyboard, press LOCK KEY. A LED on the LOCK KEY
key is activated indicating that from that moment on no changes can be made on schedule. To unlock the
keyboard, press LOCK KEY again. The LED above the key will light off LOCK KEY indicating that the
incubator can be reprogrammed.
Figure 112 - Lock key - MC1
Note:
When you turn on the incubator the keyboard will always be released for setting.
6.2.7 - OPERATION OF ALARMS

The SCTI LINE 4 incubator has an alarm system, whose function is to alert the equipment user on the
occurrence of a patient's clinical situation out of normal limits on any problems or technical issues of the
equipment.
In all alarms activated, an intermittent alarm and a red indicator LED light is activated. The audio can be muted
temporarily, but the visual indication will remain until the normal condition is restored.
Note:
- SILENT ALARM key
- 63 -
Through the SILENT ALARM key, the user can inhibit the tone of some alarms (see alarm
function) for a period of 15 minutes. In this condition, the alarm will continue to be indicated by a
red LED (alarm) and the indicator LED of the silent alarm is activated showing to the user that the
alarm is silenced. In case of another alarm activation, even if the alarm is inhibited, the activation
will be emitted by the equipment.
- If the alarm condition remains beyond 15 minutes, the alarm will be reactivated and the indicator
LED of silent alarm will be turned off, the user will be able to inhibit the sound activation for
another 15 minutes pressing the SILENT ALARM key again.
- Always check the cause of activation of alarms to ensure the patient safety.
Note:
- Priority of alarm condition: all alarms indicated by the SCTI LINE 4 incubator are considered high priority.
- Level of sound pressure of alarms: a 3m distance, perpendicular to the front of the incubator and
approximately 1.5 m above the floor is at least 65 dB.
- Delay time inherent to the determination of the alarm condition: the delay time for the alarm activation is less
than 5 seconds.
- Delay in alarm system: the alarm system has time to detection of alarms less than 5 seconds.
CAUTION
- The alarm that cannot be silenced by SILENT ALARM key:
- Alarm of air circulation;
- Alarm of engine failure;
- Alarm of power failure;
- Alarm of overheating (can only be silenced if not on the risk range);
- Alarm of system failure.
GENERAL:
1) Alarm of power failure
This alarm is activated when the power supply by mains of 127 / 220V ~ is interrupted. To activate this alarm,
the equipment uses its internal battery as a power source. This battery is rechargeable and is constantly
recharged while the incubator is being powered by AC mains. The battery keeps the programmed parameters
for a maximum period of 15 minutes without AC supply mains. In addition to the sound alert, there will be a
visual indication of "POWER FAILURE" via red LED on the panel and LED on. The alarm cannot be inhibited
by the SILENT ALARM key until you reset the AC mains supply. Whenever the alarm is activated, the operator
must verify the cause of problem, because in that condition the monitoring systems, air circulation and heating
will be turned off.
2) Alarm of air circulation
This alarm is activated if the engine stop, problem in the fan or reduction of airflow. In addition to the sound
alert, there will be a visual indication of "CIRCULATION FAILURE" via red LED on the display. The alarm
cannot be silenced by the SILENT ALARM key. Whenever the air circulation alarm is activated the incubator
automatically will turn off all servo control systems.
CAUTION
- Whenever the circulation alarm is activated, remove the patient from the incubator because in this
condition the air inside the RN compartment is not being renewed.
- Sudden changes in the temperature inside the incubator dome can cause the alarm activation. If the
alarm is activated, the incubator holds on for 10 minutes. If the air circulation returns to normal, the
incubator will automatically turn off the alarm; if the alarm persists send the equipment to the nearest
service center.
- When the incubator is turn on the air circulation alarm it remains inhibited for 30 minutes.
3) Alarm of system failure
This alarm is activated when the electronic systems detect the failure of any component or operation routine.
In addition to the sound alert, there will be an indication via red LED on the panel and a CODE on the display.
The CODE is the indication of failure occurred in the system. The alarm can not be silenced by the SILENT
ALARM key. Whenever the system failure alarm is activated the incubator automatically will turn off all servo
control systems.
4) Alarm of engine failure
This alarm is activated when the electronic system detects a failure in the engine or electronic whip associated
to it. In addition to the sound alert, there will be an indication via red LED on the panel and a CODE on the
display. The alarm can not be silenced by the SILENT ALARM key. Whenever the engine failure alarm is
activated the incubator automatically will turn off all servo control systems.
- 64 -
TEMPERATURE:
5) Alarm of high temperature

This alarm is activated AR mode only when the temperature inside the dome has a difference greater than
3.0°C related to the desired programmed temperature. In addition to the sound alert, there will be an indication
via red LED on the panel. The alarm can be inhibited by the SILENT ALARM key for a period of 15 minutes.
By the end of such period, if the hot air condition persists the sound alert is activated again.
CAUTION
- Activation of alarm during the normal use for long periods may show some kind of technical
problem. If so, call a service center.
6) Alarm of low temperature

3.0°C lower than the desired programmed temperature. In addition to the sound alert, there will be an
indication via red LED on the panel. The alarm can be silenced by the SILENT ALARM key for a period of 15
minutes. By the end of such period, if the cold air condition persists the sound alert is activated again.
CAUTION
7) Alarm of RN sensor failure

This alarm is activated RN mode only when the sensor is disconnected from the equipment (by the user or
accidentally). In this condition, the RN display will indicate the temperature and will not work in the RN mode,
assuming the AR mode automatically. In addition to the sound alert, there will be an indication via red LED on
the panel. The alarm can be inhibited by the SILENT ALARM key.
CAUTION
- When the RN sensor is shorted, the sensor failure alarm will be activated, but can be inhibited.
8) Alarm of hyperthermia
This alarm will be activated RN mode only and will be activated whenever the difference between the desired
temperature set by the user and the newborn temperature is greater than 1.0°C. In addition to the sound alert,
there will be a visual indication via red LED on the panel. The alarm may be inhibited by SILENT ALARM key
for a period of 15 minutes. At the end of such period, if the patient’s hyperthermia condition persists, the alarm
will be reactivated.
9) Alarm of hyporthermia
This alarm will be activated in the RN mode only and will be activated whenever the difference between the
desired temperature set by the user and the newborn temperature is greater than 1.0°C lower than the desired
and programmed temperature. Beyond the sound alert, there will be a visual indication via red LED on the
panel. The alarm may be inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such
period, if the patient’s hyporthermia condition persists, the alarm will be reactivated.
10) Alarm of overheating

For more safety, the electronic circuits and temperature sensor responsible for activation of such alarm are
independent of micro processed thermostat. This alarm is activated when the temperature inside the dome
exceeds 37.8 ° C (if the set point is lower than 37ºC), or 39.8°C (if the set point is greater than 37ºC). In
addition to the sound alert, there will be an indication via red LED on the panel. The alarm cannot be silenced
by SILENT ALARM key (except when out of risk range, less than or equal to 37ºC, if the set point is lower than
37ºC, and less than or equal to 39°C, when the set point is greater than 37°C). These indications will remain
until the air temperature is lower, enabling again the resistance and thus keeping it. Whenever the overheating
alarm is activated the incubator automatically will turn off all servo control systems.
CAUTION
- The use of the incubator in environments with high temperature, direct exposure to sunlight,
incandescent light, thermal mattresses and phototherapy can cause the alarm activation.
- For added security, the electronics and temperature sensor, responsible for triggering this alarm
is independent microprocessor thermostat.
- 65 -
6.2.8 - CHECK OF ALARM SYSTEMS
Use the following procedure to check the alarms operation of the SCTI LINE 4 incubator.
Before you start checking ensure that:
- The incubator has no patient on it.
- The RN sensor is disconnected from the panel.
- The power cable is properly connected to the electrical mains.
1- Press ON key on the control panel and check if the display lights and the system boot begins.
2- Set the desired temperature of 37.0ºC for the air. (See item 6.2.1 - Use of AR mode) Check if the
heating is on.
3- Wait the temperature to stabilize. Open the dome and check if the temperature indicated for AR on the
front panel will fall. The Low Temperature alarm should be activated as soon as the temperature
indicated for AR falls below 34.0°C. Close the dome after the alarm activation.
4- Connect the RN sensor on the side panel and select the RN mode (See item 6.2.2 - Use the RN
mode).
5- Set the desired temperature of 37.0ºC for the RN mode. Position the RN sensor at 10cm away high on
the center of the mattress Wait for the temperature stabilization (RN temperature shown in the display
should be near the desired temperature, i.e., 37.0°C). Before continuing the test, make sure there is
no alarm activated.
6- Remove the RN sensor from the inside of the dome, leaving it exposed to room temperature. Verify if
activation of the Hypothermia alarm occurs, which should occur when the temperature indicated for
the RN is 1.0°C lower than the desired temperature.
7- Place the RN sensor in a container with water under temperature above 38.0°C, for example, water
taken from a tap with heater or an electric shower. Check if the RN temperature rise indicated by the
control module occurs. The Hyperthermia alarm should be activated when the RN temperature
indicated on the display is 1.0°C above the desired temperature. In this situation the heating indicator
should be turned off.
8- Disconnect the RN sensor of the side panel and check the activation of the Sensor Failure alarm
9- On the Incubator front panel select the condition in "AR mode" and adjust the temperature to 36.0°C.
Allow the system to stabilize for about 30 minutes. After this stabilization obstruct the inlet or output of
ventilation in the incubator tray. In the 15-120 seconds range, it shall operate the sound and visual
Circulation Ar alarm. Let the air passage free.
10- Disconnect the power cable from the mains. Make sure the Power Failure alarm is activated.
11- Press the Off key on the control panel.
12- If any tests described do not result in the activation of alarms, request the visit of the nearest service
center.
Note:
- To ensure the patient’s safety, perform this procedure to check the alarms weekly.
- The alarms check does not guarantee the perfect operation of the equipment. The temperature calibration
and test of some alarms can be done by the service center only. Send your incubator to periodic reviews at
intervals not exceeding 6 months.
- 66 -
PANEL
Figure 113- - Panel of control module MC 2
1 ON / OFF KEY
2 INDICATOR OF EQUIPMENT ON
3 INDICATOR OF RN OPERATION MODE
4 DESIRED TEMPERATURE INCREASE KEY
5 DESIRED TEMPERATURE REDUCTION KEY
6 SILENT ALARM KEY
7 ALPHANUMERIC DISPLAY
8 INCREASE OF HUMIDITY KEY
9 REDUCTION OF HUMIDITY KEY
11 HOT AIR ALARM INDICATOR
12 COLD AIR ALARM INDICATOR
13 TARE KEY
14 HYPOTHERMIA ALARM INDICATOR
15 HYPERTHERMIA ALARM INDICATOR
16 SETTING KEY GREATER THAN 37ºC
17 DESIRED TEMPERATURE > 37°C INDICATOR
18 INDICATOR OF AR OPERATION MODE
19 SELECTION KEY OF OPERATION MODE
22 ALARM INDICATOR
23 SILENT ALARM INDICATOR
Use of Electrical Mains

CAUTION
- SCTI LINE 4 Incubator can be connected to electrical mains automatic 127/220 V~, frequency
50/60 Hz
- Turn on the electrical main key located on the control module on the right side of the incubator.
- Press the ON key on the control panel

operation mode, the incubator has HOT AIR and COLD AIR alarms which will be activated when the
- Check if the dome sensor is connected.
- The equipment comes with set point manufacturer-programmed to 34°C. Whenever the equipment is turned
- 67 -
(above 37ºC):
- Increase the desired temperature to 37ºC, so the sound alert will work for 3 seconds and the LED (> 37ºC)
will be activated.
- Press SETTING GREATER THAN 37ºC to enable a set point between 37.1ºC to 39ºC, the LED will display
as shown in Figure 115.
"
Figure 115 - LED indicator key "> 37°C" activated
Figure 116 - Set point of AR temperature above 37ºC
Notes:
- 68 -

B. RN sensor
C. RN skin

- To set the desired value for the RN temperature, press the OPERATION MODE key so the incubator may go
to the RN mode.
- The equipment comes with set point manufacturer-programmed to 36.1°C. Whenever the equipment is
turned off, the value programmed restarting the RN operation mode will be manufacturer-programmed.
(above 37ºC):
- Increase the desired temperature to 37ºC, so the sound alert will work for 3 seconds and the LED (> 37ºC)
will be activated.
- Press the SETTING GREATER THAN 37ºC key to enable a set point between 37.1ºC to 38ºC, the LED will
display as shown in Figure 119.
- 69 -
Figure 119 - LED indicator button "> 37°C”
Notes:
CAUTION
patient.
- 70 -
6.3.3 - HUMIDITY CONTROL
The SCTI LINE 4 Incubator may administer humidity in two different ways.
Relative passive humidity of air (optional).
Servo control of Relative humidity of air
Relative passive humidity of air (optional)

change. The use of water is optional; the equipment can operate normally with no water in the tank.
- Turn on the incubator; the hot air flow produced by the control panel will pass over the water surface, causing
Note:
CAUTION
- The humidity level inside the incubator will depend on the relative humidity of the environment air.
Servo control of Relative humidity of air (optional module)

In the servo-controlled mode, the incubator provides a stable control of humidity in the newborn compartment.
In this operation mode, the incubator has HIGH and LOW HUMIDITY alarms which will be activated when the
humidity is checked for compartment with a difference greater than 5% related to the desired humidity.
This servo-controlled system allows the incubator operator to monitor and set the relative humidity inside the
The desired value for the relative humidity of air can be set within the range of 20 to 95% in increments of 1%.
The actual value and the desired value of relative humidity air will be indicated on the control panel.
Filling the water tank:
- Pull out the water tank about 28cm, and carefully apply a constant force to prevent spillage of its content (if
there is water in the tank).
- Remove the tank cover.
- Fill or replace the tank water to the level indicated keeping the water between the minimum and maximum
ranges. The excess of water can cause delay in humidifying the incubator and risk of overflow when the
incubator is tilted.
- Replace the tank cover.
- Return the tank to its normal position.
- 71 -
Figure 122 - Filling the tank
Note:
- It is not necessary to remove the tank to supply the equipment during operation, thus preventing the servo
controls are stopped.
CAUTION
Setting the relative humidity inside the dome:

- To set the desired humidity value, use the increase and decrease of humidity keys.
- After finishing the program, the servo controlled humidification system o the SCTI LINE 4 incubator will start
to heat the tank, increasing the water evaporation until the relative humidity reaches the value predetermined
by the operator, keeping then the humidity close to the programmed value.
Figure 123 - Display - humidification control MC2

Notes:
- The use of servo controlled humidification system is optional. To disable the system, program the desired
humidity to 20% and then press the reduction key again. The display will continue showing the relative
humidity inside the dome and the desired value will be deleted.
- Whenever the tank with water level is low, the servo controlled humidification system will remain disabled.

The SCTI LINE 4 Incubator may administer oxygen in two different ways.
• Limiting oxygen valve (inlet to limited 8Lpm)
• Passive oxygen valve (optional - inlet limited to 64Lpm)
- 72 -
Note:
- The limiting oxygen valve is a line item if the customer chooses the passive oxygen valve, the composition of
equipment will be as follows:
- Limiting oxygen valve;
- Passive oxygen valve.
CAUTION
-Read and understand the warnings contained in item 3 – Warnings and/or precautions to be taken
-The air inside the newborn compartment should be enriched only with oxygen under prescription.

stabilized.
hospital oxygen cylinder to the oxygen inlet valve nipple from the incubator as Figure 124.
portholes opening.
Note:
the table.
Inlet Flow (L/min) 0 2 4 6 8 10 12 15
O2 Concentration (%) 21 21 – 28 22 – 32 24 – 34 27 – 40 30 – 42 32 – 44 35 - 50
- 73 -
CAUTION
- Oxygen therapy may raise the noise level for the RN inside the incubator.
immediately.
- Keep all ignition sources (e.g., matches, cigarettes, devices that produce sparks, etc..) away from
Operating Mode of Passive Oxygen Valve (Optional Module)

stabilized.
mains or hospital oxygen cylinder to the oxygen inlet valve nipple from the incubator as Figure 125.
Note:
the table.
Inlet Flow (L/min) 0 2 4 6 8 10 12 15
O2 Concentration (%) 21 21 – 28 22 – 32 24 – 34 27 – 40 30 – 42 32 – 44 35 - 50
- 74 -
CAUTION
immediately.
6.3.5 INTEGRATED BALANCE (OPTIONAL MODULE)

The SCTI LINE 4 incubator has balance with weight indication on its display. The balance has weight limit of
10kg, and accuracy of ± 5g. When this weight is exceeded the panel will indicate a BALANCE OVERLOAD
alarm.
- Press TARE key to zero the balance (the patient should not be on the mattress).
- Position the patient on the mattress and wait for the stabilization of the weight indication on the display.
Figure 126 - Display - Balance MC2
6.3.6 SERIAL COMMUNICATION

The Supervisory Program is an incubator monitoring and supervision program. It allows the monitoring,
storage, printing and analysis of all parameters in the control module of the incubator through a microcomputer
and connection of serial communication port (RS 232). The parameters indicated by the program are:
· Dome temperature;
· Newborn Temperatures;
· Desired temperature control;
· Relative humidity in the Dome interior;
· Desired Humidity;
· Related Oxygen Concentration on the dome;
· Desired Oxygen Concentration;
· Newborn Weight;
· Parameters of Pulse Oxymetry (when present in the incubator);
· Message of Pending Alarms
All parameters measured are stored and indicated in trend curves.
- 75 -
MICROCOMPUTER MINIMUM REQUIREMENTS:
• Microcomputer in accordance with IEC 60950-1 and Windows operating system (Windows 2000, XP,
Windows Seven);
• Monitor with minimum resolution of 800x600;
• Serial port (COM) (you can use a Serial adapter - USB in cases of computer with no serial port available,
optional not included);
To use the system, connect the RS 232 cable supplied with the incubator in the side of the control module and
the microcomputer serial inlet port of the incubator.
Note: To get the most appropriate use of this system, make sure that the minimum distance from the microcomputer to the incubator is
1.5 meters as shown in Figure 127.
Figure 127 - Patient Environment

Note:
To use serial communication, check the user guide "Supervisory Program" that accompanies the product and
specific software supplied on CD/DVD with the installation guide for the microcomputer.
CAUTION
- The microcomputer to be used in the system should not have only basic insulation to protect against
electric shock.
- The handling, maintenance, cleaning and environmental conditions of the microcomputer, check the
manufacturer's guide.

6.3.7.1 - LOCK KEY
parameters to be changed accidentally. To lock the keyboard, press LOCK KEY. A LED on the LOCK KEY
button is activated indicating that from that moment on no changes can be made on schedule. To unlock the
keyboard, press LOCK KEY again. The LED above the key will light off LOCK KEY indicating that the
incubator can be reprogrammed.
Figure 128 - Lock key - MC2
Note:
When you turn on the incubator the keyboard will always be released for programming.
- 76 -
equipment.
temporarily (depending of alarm, see item alarm operation), but the visual indication will remain until the
normal condition be restored.
Note:
- SILENT ALARM KEY
Through the SILENT ALARM key, the user can inhibit the tone of some alarms (see alarm function)
for a period of 15 minutes. In this condition, the alarm will continue to be indicated by a red LED
(alarms indicator) and the indicator LED of the silent alarm is activated showing to the user that the
alarm is silenced. In case of another alarm activation, even if the alarm is inhibited, the activation
will be emitted by the equipment.
- If the alarm condition remains beyond 15 minutes, the alarm will be reactivated and the indicator
LED of silent alarm will be turned off, the user will be able to inhibit the sound activation for another
15 minutes pressing the SILENT ALARM key again.
Note:
than 5 seconds.
- Delay in alarm system: the alarm system has time to detection of alarms less than 5 seconds.
CAUTION
- The alarm that cannot be silenced by SILENT ALARM key:
- Alarm of sensor modules disconnected
- Alarm of system failure;
- Alarm of engine failure;
- Alarm of overheating;
- Alarm of UR sensor failure
GENERAL:
1) Alarm of power failure
recharged while the incubator is being powered by AC electrical mains. The battery keeps the programmed
parameters for a maximum period of 15 minutes without AC supply mains. In addition to the sound alert, there
will be a visual indication of "POWER FAILURE" via red LED on the panel and LED on. The alarm cannot be
inhibited by the SILENT ALARM key until you reset the AC electrical mains supply. Whenever the alarm is
activated, the operator must verify the cause of problem, because in that condition the monitoring systems, air
circulation and heating will be turned off.
2) Alarm of air circulation

cannot be silenced by the SILENT ALARM key.
CAUTION
- Whenever the circulation alarm is activated, remove the patient from the incubator because in this
condition the air inside the RN compartment is not being renewed.
- Sudden changes in the temperature inside the incubator dome can cause the alarm activation. If the
alarm is activated, the incubator holds on for 10 minutes. If the air circulation returns to normal, the
incubator will automatically turn off the alarm; if the alarm persists send the equipment to the nearest
service center.
- When the incubator is turn on the air circulation alarm it remains inhibited for 30 minutes.
- 77 -
3) Alarm of sensor modules disconnected
This alarm is activated when the sensor modules is disconnected from the equipment (by the user or
accidentally). In addition to the sound alert, there will be an indication via red LED on the panel and an
SENSOR MODULE DISCONNECTED message on the display. The alarm cannot be silenced by the SILENT
ALARM key.
CAUTION
- The sensor module should remain connected during use of the incubator.
4) Alarm of system failure

In addition to the sound alert, there will be an indication via red LED on the panel and a SYSTEM FAILURE
(CODE) message on the display. The CODE is the indication of failure occurred in the system. The alarm can
be silenced by the SILENT ALARM key. Whenever the system failure alarm is activated the incubator
5) Alarm of engine failure

This alarm is activated when the electronic system detects a failure in the engine or electronic whip associated
to it. In addition to the sound alert, there will be a visual indication of ENGINE CIRCULATION FAILURE via
red LED on the display. The alarm cannot be silenced by the SILENT ALARM key. Whenever the engine
failure alarm is activated the incubator automatically will turn off all servo control systems.
TEMPERATURE:
6) Hot air alarm
via red LED on the panel and a HOT AIR message on the display. The alarm can be silenced by the SILENT
ALARM key for a period of 15 minutes. By the end of such period, if the hot air condition persists the sound
alert is activated again.
CAUTION
7) Cold air alarm

indication via red LED on the panel and a COLD AIR message on the display. The alarm can be silenced by
the SILENT ALARM key for a period of 15 minutes. By the end of such period, if the cold air condition persists
the sound alert is activated again.
CAUTION
8) Sensor alarm of NB disconnected;

This alarm is activated when the sensor is disconnected from the equipment (by the user or accidentally). In
this condition, the RN display will indicate the temperature and will not work in the RN mode, assuming the AR
mode automatically. In addition to the sound alert, there will be an indication via red LED on the panel and a
NB DISCONNECTED message on the display. The alarm can be inhibited by the SILENT ALARM key.
This alarm will be activated RN mode only and will be activated whenever the difference between the desired
temperature set by the user and the newborn temperature is greater than 1.0°C. In addition to the sound alert,
there will be an indication via red LED on the panel and a HYPERTHERMIA message on the display. The
alarm may be inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such period, if the
patient’s hyperthermia condition persists, the alarm will be reactivated.
- 78 -
and programmed temperature. In addition to the sound alert, there will be a visual indication via red LED on
the panel and the HYPOTHERMIA message on the display. The alarm may be inhibited by SILENT ALARM
key for a period of 15 minutes. At the end of such period, if the patient’s hyporthermia condition persists, the
alarm will be reactivated.

This alarm is activated when the temperature inside the dome exceeds 37.8 ° C (if the set point is lower than
37ºC), or 39.8°C (if the set point is greater than 37ºC). In addition to the sound alert, there will be an indication
via red LED on the panel and a OVERHEATING message on the display. The alarm cannot be silenced by
SILENT ALARM key (except when out of risk range, less than or equal to 37ºC, if the set point is lower than
37ºC, and less than or equal to 39°C, when the set point is greater than 37°C). These indications will remain
until the air temperature is lower, enabling again the resistance and thus keeping it. Whenever the overheating
alarm is activated the incubator automatically will turn off all servo control systems.
CAUTION
- For more safety, the electronic circuits and temperature sensor responsible for activation of such
alarm are independent of micro processed thermostat.
HUMIDITY (OPTIONAL):
12) Alarm of low water level
This alarm will be activated whenever the humidification system is on and the water level in the tank is below
the minimum level. In addition to the sound alert, there will be an indication via red LED on the panel and a
LOW WATER LEVEL message on the display. The alarm can be inhibited by the SILENT ALARM key.
Whenever the low level alarm is activated, in this condition, the heating of the tank will be turned off and the
servo controlled humidification system will be disabled.
13) HIGH humidity alarm

This alarm is activated when the relative humidity is indicated on the display with a difference greater than 5%
above the desired value programmed by the incubator operator. In addition to the sound alert, there will be an
indication via red LED on the panel and a HIGH HUMIDITY message on the display. The alarm may be
inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such period, if the condition of HIGH
HUMIDITY persists the alarm will be activated.
14) LOW humidity alarm

lower than the desired value programmed by the incubator operator. In addition to the audible alert, there will
be an indication via red LED on the panel and a LOW HUMIDITY message on the display. The alarm may be
inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such period, if the condition of LOW
HUMIDITY persists the alarm will be activated.
15) Alarm of UR sensor failure

This alarm is activated when the humidity sensor located inside the newborn compartment fails in the reading.
In addition to the sound alert, there will be an indication via red LED on the panel and a UR SENSOR
FAILURE message on the display. This alarm cannot be silenced by SILENT ALARM key:
BALANCE (OPTIONAL):
16) Balance disconnected alarm
This alarm is activated when the balance sensor is disconnected from the equipment (by the user or
accidentally). This alarm indicates that the balance plate connector is disconnected. In addition to the sound
alert, there will be an indication via red LED on the panel and a BALANCE DISCONNECTED message on the
display. The alarm can be inhibited by the SILENT ALARM key.
17) Balance Overload Alarm

This alarm is activated when the balance exceeds the weight limit of 10kg, when this weight is exceeded, the
panel will indicate an alarm. In addition to the sound alert, there will be an indication via red LED on the panel
and an OVERLOAD message on the display. The alarm can be inhibited by the SILENT ALARM key.
- 79 -
18) Balance Failure alarm
This alarm indicates that there was a failure in the weight reading and that may occur when one of the
weighing plate sensors are damaged or when there is a failure in the cable or connector (open or short circuit).
In addition to the sound alert, there will be an indication via red LED on the panel and a BALANCE FAILURE
message on the display. The alarm can be inhibited by the SILENT ALARM key.
6.3.9 - CHECK OF ALARMS SYSTEM

Use the following procedure to check the alarms operation of the incubator model SCTI LINE 4.
heating is on.
front panel will fall. The Cold Air alarm should be activated as soon as the temperature indicated for
AR falls below 35.5°C. Close the dome after the alarm activation.
4- Connect the RN sensor on the side panel and select the RN mode (See item 6.3.2 - Use the RN
mode).
5- Set the desired temperature of 37.0ºC for the RN mode. Position the RN sensor at 10cm away high on
no alarm activated.
8- Disconnect the RN sensor of the side panel and check the activation of the Disconnected alarm.
ventilation in the incubator tray. In the 15-120 seconds range, it shall operate the audible and visual
Circulation Failure alarm. Let the air passage free.
10- Start the humidification system, setting the desired value to 90% of all humidity. Empty humidification
system. Make sure the Low Water Level alarm is activated.
11- If there is a balance, place a weight exceeding 10 kg but not exceeding 12 Kg. Make sure the
Overload Balance alarm is activated.
12- Disconnect the balance sensor of the side panel. Check if the Disconnected alarm is activated.
13- Disconnect the power cable from the mains. Make sure the Power Failure alarm is activated
14- Press the Off key on the control panel.
center.
Note:
and test of some alarms can be done by the service center only. Send your transport incubator to periodic
reviews at intervals not exceeding 6 months.
- 80 -
PANEL
Figure 128 - Front panel MC3
1 ON / OFF KEY
2 RN TEMPERATURE RN 1
3 RN MODE INDICATOR
4 RN MODE KEY
5 AIR TEMPERATURE
6 AR MODE INDICATOR
7 AR MODE KEY
8 DESIRED TEMPERATURE INDICATOR
9 TEMPERATURE INCREASE KEY
10 TEMPERATURE REDUCTION KEY
13 BALANCE KEY
14 BPM KEY
15 SPO2 KEY
16 O2 CONCENTRATION KEY
17 RELATIVE HUMIDITY KEY
18 INCREASE KEY
19 TREND GRAPH KEY
20 SILENT ALARM KEY
21 ALARM INDICATOR
22 DESIRED TEMPERATURE GREATER THAN > 37°C INDICATOR
23 PROGRAMMING KEY GREATER THAN 37°C
26 REDUCTION KEY
27 DISPLAY OF EQUIPMENT ON
28 GRAPHIC DISPLAY
Use of Electrical Mains
CAUTION
- SCTI LINE 4 Incubator can be connected to mains automatic 127/220 V~, frequency 50/60 Hz
- Turn on the main key located on the control module on the right side of the incubator.
- Press the ON key on the control panel
- 81 -
operation mode, the incubator has HOT AIR and COLD AIR alarms which will be activated when the
- Check if the sensor module is connected.

(above 37ºC):
- Increase the desired temperature until it reaches 37ºC, and the alarm will be issued with a message " > 37ºC
RANGE DISABLED"; wait for the message to delete.
- Press the >37ºC key to enable a set point between 37.1ºC to 39ºC, the LED will display as shown in Figure
131.
Figure 131 –LED indicator “>37°C” key activated

- 82 -
Figure 132 - Set point of AR temperature above 37°C
Notes:


B. RN sensor
C. RN skin

- To set the desired value for the RN temperature, press the RN MODE key twice so the incubator may go to
the RN mode.
off, the value programmed restarting the RN operation mode will be manufacturer-programmed.
- 83 -
(above 37ºC):
- Increase the desired temperature until it reaches 37ºC, and the alarm will be issued with a message " > 37ºC
RANGE DISABLED"; wait for the message to delete.
- Press the >37ºC key to enable a set point between 37.1ºC to 38ºC, the LED will display as shown in Figure
135.
Figure 135 - LED indicator "> 37°C" key activated

- 84 -
Notes:
CAUTION
patient.
6.4.3- HUMIDITY CONTROL

The SCTI LINE 4 Incubator may administer humidity in two different ways.
Relative passive humidity of air (optional).
Servo control of Relative humidity of air (optional)
Relative passive humidity of air.

change. The use of water is optional, the equipment can operate normally with no water in the tank.

- Turn on the incubator, the hot air flow produced by the control panel will pass over the water surface, causing
Note:
CAUTION
- The humidity level inside the incubator will depend on the relative humidity of the environment air.
- 85 -
Servo control of Relative humidity of air (optional module)
In the servo-controlled mode, the incubator provides a stable control of humidity in the newborn compartment.
In this operation mode, the incubator has HIGH and LOW HUMIDITY alarms which will be activated when the
humidity is checked for compartment with a difference greater than 5% related to the desired humidity.
This servo-controlled system allows the incubator operator to monitor and set the relative humidity inside the
The desired value for the relative humidity of air can be set within the range of 20 to 95% in increments of 1%.
The actual value and the desired value of relative humidity air will be indicated on the control panel.
Filling the water tank:
- Pull out the water tank about 28cm, and carefully apply a constant force to prevent spillage of its content (if
there is water in the tank).
- Remove the tank cover.
- Fill or replace the tank water to the level indicated keeping the water between the minimum and maximum
ranges. The excess of water can cause delay in humidifying the incubator and risk of overflow when the
incubator is tilted.
- Replace the tank cover.
- Return the tank to its normal position.
Figure 138 - Filling the water tank

Note:
- It is not necessary to remove the tank to supply the equipment during operation, thus preventing the servo
controls are stopped.
CAUTION
Setting the air relative humidity inside the dome:
- To set the desired humidity value, use the increase and decrease of humidity keys.
- After finishing the program, the servo controlled humidification system o the SCTI LINE 4 incubator will start
to heat the tank, increasing the water evaporation until the relative humidity reaches the value predetermined
by the operator, keeping then the humidity close to the programmed value.
Figure 139 - Display - humidification control MC3

- 86 -
Notes:
- The use of servo controlled humidification system is optional. To disable the system, program the desired
humidity to 20% and then press the reduction key again. The display will continue showing the relative
humidity inside the dome and the desired value will be deleted.
- Whenever the tank with water level is low, the servo controlled humidification system will remain disabled.

The SCTI LINE 4 Incubator may administer oxygen in three different ways, but it will be manufacturer-
delivered in two-way maximum.
• limiting oxygen valve (inlet to limited 8Lpm)
• passive oxygen valve (optional - inlet limited to 64Lpm)
• oxygen servo control (optional - inlet limited to 64Lpm).
Note:
- The limiting oxygen valve is a line item; if the customer chooses the passive oxygen valve or the servo
control of oxygen, the composition of equipment will be as follows:
- limiting oxygen valve;
- Passive oxygen valve or oxygen servo control.
CAUTION
-Read and understand the warnings contained in item 3 – Warnings and/or precautions to be taken
-The air inside the newborn compartment should be enriched only with oxygen under prescription.

stabilized.
hospital oxygen cylinder to the oxygen input valve nipple from the incubator as Figure 140.
portholes opening.
Note:
the table.
- 87 -
Input Flow (L/min) 0 2 4 6 8 10 12 15
O2 Concentration (%) 21 21 – 28 22 – 32 24 – 34 27 – 40 30 – 42 32 – 44 35 - 50
CAUTION
immediately.
Operating Mode of Passive Oxygen Valve (Optional Module)

stabilized.
mains or hospital oxygen cylinder to the oxygen input valve nipple from the incubator as Figure 141.

Note:
the table.
- 88 -
Input Flow (L/min) 0 2 4 6 8 10 12 15
O2 Concentration (%) 21 21 – 28 22 – 32 24 – 34 27 – 40 30 – 42 32 – 44 35 - 50
CAUTION
immediately.
Oxygen Servo Control (Optional Module)

In the servo control mode, the incubator provides a stable control of oxygen in the newborn compartment
through an automatic activation of the solenoid valve according to the value set by the operator. In this
operation mode, the incubator has HIGH LEVEL OF O2 and LOW LEVEL OF O2 alarms which will be
activated whenever the oxygen checked for compartment has a difference greater than 3% related to the
desired oxygen. The desired value for the oxygen temperature can be set within the range of 21 to 65% in
increments of 1%.
The actual value and the desired value of oxygen concentration shall be indicated in the display. How to
use the oxygen mode:
stabilized.
- Through a pressure hose with braided nylon 250 PSI nontoxic, connect the flow meter output in the
vehicle mains or the hospital oxygen cylinder to the oxygen input valve nipple from the incubator as Figure
142.
Figure 142 - Connection for operation of oxygen servo control valve

- Calibrate the oxygen sensors as item "calibration of oxygen sensors" page 94.To set the desired value for
oxygen, press the O2 field on the display
- To set a value, use the INCREASE or DECREASE keys of parameters.
- 89 -
- After finishing the programming, the servo controlled oxygen system of the SCTI LINE 4 incubator will
initiate the process until the oxygen reaches the value predetermined by the operator, keeping the oxygen
near to the programmed value.
Figure 143 - Display - Oxygen Control MC3
Notes:
- Within the field O2, the largest number (bottom) represents the current value read. The smaller number
(top) represents the programmed value.
- The use of servo -controlled oxygen system is optional. To deactivate the system, press the reduction key
of parameters until the minimum value (21%) is reached then presses the reduction key again. The display
will continue to indicate the oxygen concentration inside the newborn compartment and the desired value
will be deleted.
- Press the O2 key when the servo-controlled oxygen system is off, the initial value indicated for desired O2
concentration is 21% (minimum value).
- For the servo controlled oxygen system to function properly, calibrate the oxygen sensors at intervals of
no more than 10 days or every time the incubator is turned on.
CAUTION
- It is recommended a daily calibration to maintain accurate system.
- Monitor with an Oxygen Analyzer properly calibrated at O2 concentration in RN compartment and
compare with the value indicated on the incubator display.
- The oxygen administration can increase the noise level for the RN within the incubator.
- Improper use of supplemental oxygen may be associated with serious side effects including
concentration and duration of oxygen administration should be prescribed by a physician skilled in
attendance of risks and benefits.
immediately.
- Oxygen administration should only be made under the supervision of qualified medical personnel.
- The oxygen concentration inhaled by a child does not determine previously the partial oxygen
- Opening the access port may cause a drop in oxygen concentration. To make a new
measurement, wait a while so the concentration is restored.
- Keep all ignition sources (e.g., matches, cigarettes, sparking equipment, etc..) away from the room
where the incubator is operating. Fabrics, oils or other fuels ignite easily when the air is enriched
with oxygen.
Calibration of oxygen sensors:

This procedure is fast (less than 60 seconds) and is essential for the correct operation of the equipment.
To calibrate the equipment, follow the following procedure:
Pull the sensor module until you hear an alarm as Figure 144
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Figure 144 - Sensor module (calibrating O2)
- The equipment will sound an alarm and the graph display will show the following message: "Calibrating the
O2 sensor"
- After a period of approximately 30 seconds, another alarm will sound and the following message appears on
the display: "Calibration Complete".
- Return the sensor module to its position within the incubator.
The calibration of oxygen sensors is finished.
Note:
- To perform this calibration procedure, make sure that the room where the incubator is installed shows normal
concentration of oxygen (21%).
6.4.5 OXYMETRY OF INTEGRATED PULSE (OPTIONAL MODULE)

The oxymetry system of integrated pulse allows the heart rate (BPM), the rate of saturated hemoglobin with
oxygen in the blood (SPO2) and plethysmographic curve are monitored in the graphic display of control panel.
The system also has programmable security alarms for monitored parameters. How to use the sensors:
- Turn on the incubator and wait for the stabilization of the inner temperature.
- Check if the sensor is connected to the side panel and to the RN.
- There are two types of sensors and adhesives available for oxymetry. The use of each type of sensor and
adhesive for fixation will depend on the size of patients, as shown below:
Patients up to 2Kg Patients between 2-10 kg
Sensor 1 \ Adhesive 1 Sensor 2 \ Adhesive 2
PROCEDURE FOR PLACEMENT OF SENSORS SENSOR 1 SENSOR 2
- Remove the adhesive protector of the fixation sensor.
- Fix the adhesive in the oxymetry sensor.
- Place the sensor on the patient skin surface (finger or

foot).
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- The side of the sensor containing the light emitting
should be on the top side of the foot or on the side of
finger nail; the detector must be in the opposite side. By
placing the sensor on the patient, try to let the receiver and
detector aligned to ensure the best possible signal for the
system.
- Fix the adhesive in the sensor, rolling it over the foot or

finger skin of the patient, taking care not to obstruct blood
flow.
- To ensure a good result in the sign reading, attach the

sensor cable (regardless adhesive sensor) with a ribbon,
as shown in Fig. Be careful one more time not to obstruct
the blood flow.
Note:
- If the sensor is not positioned correctly, the oxymetry system may not function properly.
- The proper placement of the oxymetry sensor is essential for the system operation. Follow carefully the
indicated guidelines.
CAUTION
- Do not use oxymetry sensors that are not provided directly by OLIDEF or its authorized
representatives.
- Discontinue the use of oxymetry sensor if the fixation adhesive cause allergic reactions to the
patient.
- Do not use damaged oxymetry sensors.
- The oxymetry sensors should not be immersed in water or any kind of solution.
- Do not use abrasive or corrosive products to clean the sensors.
Heart Rate (BPM)

In monitoring mode, the incubator has HIGH FREQUENCY OF HEART RATE alarms and LOW FREQUENCY
OF HEART RATE that will be activated when the heart rate reaches the programmed limits.
The monitoring rate will be from 20 to 250 bpm, and the activation limits of the alarms can be set within a
range of 40 to 250bpm in increments of 1bpm.
The reading value and limits set will be indicated on the control panel. How to set limits:
- The equipment comes with alarm limits for heart rate set at 80 and 180 bpm. Whenever the equipment is
turned off, the value set will be the manufacturer-programmed at new start of this monitoring mode.
- To set the maximum limit, press the BPM key. To set a maximum value, use the INCREASE or DECREASE
keys of parameters.
- To set the minimum value, press the BPM key twice. To set a minimum value, use the INCREASE or
DECREASE keys of parameters.
Figure 145 - Graphic Display - Heart rate BPM
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Notes:
- Within the field BPM, the largest number (bottom) represents the current value read. Smaller numbers (top)
represent the maximum and minimum alarms.
- The maximum or minimum values within the " MAX BPM " limit will be directly related to the maximum and
minimum "MIN BPM" limit.
- The use of oxymetry is optional. To turn off the system, disconnect the sensor from the sensors’ module in
the incubator and silence the alarm.
- Pulse rate below 20 (except zero) will be displayed as 20 and above 250 will be displayed as 250. A pulse
frequency zero is used to indicate that the monitor is not monitoring the pulse.
SPO2
In this monitoring mode, the incubator has alarms of HIGH SPO2 and LOW SPO2, which will be activated
whenever the rate of hemoglobin saturated with oxygen in the blood reaches the programmed limits. The
monitoring rate will be from 0 to 100% bpm, and the activation limits of the alarms can be set within a range of
50 to 100% in increments of 1%.
The reading value and limits set will be indicated on the control panel. How to set limits:
- The equipment comes with alarm limits for SPO2 set at 90 and 100 bpm. Whenever the equipment is
turned off, the value set will be the manufacturer-programmed at new start of this monitoring mode.
- To set a maximum value, use the SPO2 key. To set a maximum value, use the INCREASE or
REDUCTION of parameters.
- To set the minimum value, press the SPO2 key twice. To set a minimum value, use the INCREASE or
DECREASE keys of parameters.
Figure 146 - Graphic Display - SPO2
Notes:
- Within the field SPO2, the largest number (bottom) represents the current value read. Smaller numbers (top)
represent the maximum and minimum alarms.
- The maximum or minimum values within the " MAX SPO2 " limit will be directly related to the maximum and
minimum "MIN SPO2 " limit during the setting.
- The use of oxymetry is optional. To turn off the system, disconnect the sensor from the sensors’ module in
the incubator and silence the alarm.
Plethysmographic Curve
- In this mode you can view the plethysmographic curve. This system shows the plethysmographic curve
proportional to the pulse volume.
- To view the plethysmographic curve, press the BPM or SPO2 key twice (if the heart trend rate graph is
displayed, press the BPM or SPO2 only once).
- An alarm will sound every good perfusion of the patient. To disable the alarm, press the silent alarm. To
reactivate it, press the silent alarm again.
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Figure 147 - Graphic Display - Plethysmographic Curve
6.4.6 - INTEGRATED BALANCE (OPTIONAL MODULE)

The SCTI LINE 4 incubator has balance with weight indication on its graphic display. The balance has weight
limit of 10kg, and accuracy of ± 5g. When this weight is exceeded the panel will indicate a BALANCE
OVERLOAD alarm.
- Press TARE key to zero the balance (the patient should not be on the mattress).
- Position the patient on the mattress and wait for the stabilization of the weight indication on the graphic
display.
Figure 148 - Display - Balance MC3
6.4.7 SERIAL COMMUNICATION

The Supervisory Program is an incubator monitoring and supervision program. It allows the monitoring,
storage, printing and analysis of all parameters in the control module of the incubator through a microcomputer
and connection of serial communication port (RS 232). The parameters indicated by the program are:
• Dome temperature;
• Newborn Temperatures;
• Desired temperature control;
• Relative humidity in the Dome interior;
• Desired Humidity;
• Related Oxygen Concentration on the dome;
• Desired Oxygen Concentration;
• Newborn Weight;
• Parameters of Pulse Oxymetry (when present in the incubator);
• Message of Pending Alarms
All parameters measured are stored and indicated in trend curves.
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MICROCOMPUTER MINIMUM REQUIREMENTS:
• Microcomputer in accordance with IEC 60950-1 and Windows operating system (Windows 2000, XP,
Windows Seven);
• Monitor with minimum resolution of 800x600;
• Serial port (COM) (you can use a Serial adapter - USB in cases of computer with no serial port available,
optional not included);
To use the system, connect the RS 232 cable supplied with the incubator in the side of the control module and
the microcomputer serial inlet port of the microcomputer.
Note: To get the most appropriate use of this system, make sure that the minimum distance from the microcomputer to the incubator is 1.5
meters as shown in Figure 149.
Figure 149 - Patient Environment

Note:
- To use serial communication, check the user guide "Supervisory Program" that accompanies the product and
specific software supplied on CD/DVD with the installation guide for the microcomputer.
CAUTION
- The microcomputer to be used in the system should not have only basic insulation to protect against
electric shock.
- The handling, maintenance, cleaning and environmental conditions of the microcomputer, check the
manufacturer's guide.
6.4.8 - TREND GRAPHICS

The Incubator SCTILINE 4 has a display system of parameters through Trend Graphic. Pressing the TREND
GRAPHIC key you can change the viewing time.
The parameters that can be viewed in Trend Graphs are:
AR Temperature;
RN Temperature;
Air Relative Humidity (optional);
Oxygen (optional);
Heart Rate (BPM) (optional);Heart Rate (BPM)
SPO2 (optional);
Balance (optional).
For some time parameters the trend monitoring time is 30 minutes.

The graphs are presented with the desired parameter on the ordinate axis and the time in hours on the
abscissa axis.
Notes:
- You must enter values in balance mode only.
- Pressing the TREND GRAPHIC you can change the viewing time 30 in 30 minutes, 1 in 1 hour, 2 in 2 hours,
3 in 3 hours, 4 in 4 hours, 6 in 6 hours, 12 in 12 hours
AR Temperature Trend
To view the trend graphic for air temperature, press the AR MODE key.
The graphic display will present a graphic where air temperature can be analyzed over time:
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Figure 150-Trend Graph for AR temperature
RN Temperature Trend
To view the trend graphic for RN temperature, press the MODE key.
The graphic display will present a graphic where the RN temperature can be analyzed over time:
Figure 151-Trend Graph for RN temperature
Humidity Trend
To view the concentration trend of air humidity inside the newborn compartment, press the RELATIVE
HUMIDITY key.
The graphic display will present a graphic where the humidity concentration can be analyzed over time:
Figure 152-Trend Graphic for UR concentration
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Oxygen Trend
To view the oxygen concentration trend, press the O2 CONCENTRATION key.
The graphic display will present a graphic where the O2 concentration can be analyzed over time:
Figure 153-Trend Graphic for O2 concentration
Heart Rate Trend (BPM)

To view the heart rate trend, press the BPM key.
The graphic display will present a graphic where the heart rate (BPM) can be analyzed over time:
Figure 154-Trend Graphic for BPM
SPO2 Trend
To view the SPO2 trend, press the SPO2 key.
The graphic display will present a graphic where the SPO2 can be analyzed over time.
Figure 155-Trend Graphic for SPO2

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Balance Trend
To view the balance graphics, press the BALANCE key. Use the increase or decrease keys to access the
"insert" mode, press the BALANCE key again to enter the patient's weight.
A bar corresponding to the patient's weight will be automatically created on the trend graphic. If more weight
values are stored in the same day, only the last value will be shown in the trend graphic.
The time scale of the relative graphic is automatically adjusted, allowing the storage of up to 10 consecutive
days.
Figure 156-Trend Graphic for balance

6.4.9.1 - KEYBOARD LOCK
parameters to be changed accidentally. To lock the keyboard, press KEYBOARD LOCK key. A LED on the
KEYBOARD LOCK key is activated indicating that from that moment on no changes can be made on
programming. To unlock the keyboard, press KEYBOARD LOCK key again. The LED above the KEYBOARD
LOCK key will light off indicating that the incubator can be reprogrammed.
Figure 157 - Keyboard Lock - MC3
Note:
When you turn on the incubator the keyboard will always be released for programming.
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6.4.9.2 - DATE AND HOUR
The control panel has an additional resource indicating date and hour as figure 158.
Figure 158 - Date and Hour

How to set hour and date:
- To set hour and date, press the KEYBOARD LOCK key (approx. 3 seconds) as Figure 159.
- To skip the hour and date fields, press AR MODE key.

- Set the hour and date, press the TEMPERATURE INCREASE and TEMPERATURE REDUCTION.
Figure 160 - Setting of Date and Hour

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- After set hour and date, press the ON/OFF key to save the values; the incubator will return to the previous
screen.
Note:
- Keep these adjusted data correctly so trend graphics can show the data correctly.
- The clock is accurate to ± 1 second every 24 hours.
6.4.9.3 - CONTRAST
The control panel has an additional resource for control setting as figure 161.
Figure 161 - Contrast Setting
How to set the contrast:

- To set the contrast, press the KEYBOARD LOCK key (approx. 3 seconds) as Figure 162.
- To set the contrast, press the INCREASE and DECREASE keys.

- After set contrast, press the ON/OFF key to save the values; the incubator will return to the temperature
control screen.
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6.4.9.4 - KANGAROO MODE
The KANGAROO MODE is used so the mother can have contact with the RN, opening the incubator port for
greater access. This mode inhibits some alarms that would be generated by opening the port.
How to use the KANGAROO MODE.
- Press the AR MODE (approx. 3 seconds) as shown in Figure 163.
Figure 163 - Ar Mode - MC3
- The incubator will enter the KANGAROO MODE; to exit, press again the AR MODE key (approx. 3 seconds).
Figure 164 - Kangaroo Mode
6.4.9.5 - NIGHT MODE

The NIGHT MODE sets the screen contrast, decreasing the brightness of the display.
How to use the NIGHT MODE.
- Press the SILENT ALARM key (approx. 3 seconds) as shown in Figure 165.
Figure 165 - Silent alarm - MC3

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- The incubator will enter the NIGHT MODE; to exit, press again the SILENT ALARM key (approx. 3 seconds).
Figure 166 - Night mode

equipment.
temporarily (depending of alarm, see item alarm operation), but the visual indication will remain until the
normal condition be restored.
Note:
- SILENT ALARM Key
- Through the SILENT ALARM key, the user can inhibit the tone of some alarms (see alarm function)
for a period of 15 minutes. In this condition, the alarm will continue to be indicated by a red LED in the
panel control. In case of another alarm activation, even if the alarm is inhibited, the activation will be
emitted by the equipment.
- If the alarm condition remains beyond 15 minutes, the alarm will be reactivated and the indicator LED
of silent alarm will be turned off, the user will be able to inhibit the sound activation for another 15
minutes pressing the SILENT ALARM key again.
- If the alarm condition remains beyond 2 minutes, the alarm will be reactivated and the indicator LED
of silent alarm will be turned off, the user will be able to inhibit the sound activation for another 2
minutes pressing the SILENT ALARM key again.
Note:
than 5 seconds.
- Delay in the alarm system: the alarm system has time to detection of alarms less than 5 seconds.
CAUTION
- The alarms that cannot be silenced by SILENT ALARM key:
- Alarm of dome sensors disconnected;
- Alarm of system failure;
- Alarm of misplaced module of sensors;
- Alarm of air sensor failure;
- Alarm of overheating.
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GENERAL:
1) Alarm of power failure;
recharged while the incubator is being powered by AC electrical mains. The battery keeps the programmed
parameters for a maximum period of 15 minutes without AC supply mains. In addition to the sound alert, there
will be a visual indication of "POWER FAILURE" via red LED on the panel and LED on. The alarm cannot be
silenced by the SILENT ALARM key until you reset the AC electrical mains supply. Whenever the alarm is
activated, the operator must verify the cause of problem, because in that condition the monitoring systems, air
circulation and heating will be turned off.
2) Alarm of air circulation failure;

cannot be silenced by the SILENT ALARM key. Whenever the air circulation alarm is activated the incubator
CAUTION
- Sudden changes in the temperature inside the incubator dome can cause the alarm activation. If
the alarm is activated, the incubator holds on for 10 minutes. If the air circulation returns to
normal, the incubator will automatically turn off the alarm; if the alarm persists send the equipment
to the nearest service center.
- Whenever the circulation alarm is activated, remove the patient from the incubator because in
this condition the air inside the RN compartment is not being renewed.
3) Alarm of dome sensors disconnected;

This alarm is activated when the dome sensor is disconnected from the equipment (by the user or
accidentally). In addition to the sound alert, there will be an indication via red LED on the panel and a
SENSOR MODULE DISCONNECTED message on the display. The alarm cannot be silenced by the SILENT
ALARM key. Whenever the alarm module of disconnected sensors are triggered the incubator will
automatically turn off all servo control systems.
CAUTION
- The sensor module should remain connected during use of the incubator.
4) Alarm of system failure.

In addition to the sound alert, there will be an indication via red LED on the panel and a SYSTEM FAILURE
(CODE) message on the display. The CODE is the indication of failure occurred in the system. The alarm
cannot be silenced by the SILENT ALARM key. Whenever the system failure alarm is activated the incubator
5) Alarm of misplaced module of sensors;

This alarm is activated when the sensor module of the incubator is out of the correct position for operation. In
addition to the sound alert, there will be an indication via red LED on the panel and a SENSOR MODULE
MISPLACED message on the display. The alarm cannot be silenced by the SILENT ALARM key. Whenever
the sensor module misplaced alarm is activated, the incubator automatically will turn off all servo control
systems.
TEMPERATURE:
6) Alarm of air sensor failure
This alarm is activated when the air temperature sensor is disconnected from the control module or is
defective, preventing the equipment operation. In addition to the sound alert, there will be an indication via red
LED on the panel and an AIR SENSOR FAILURE message on the display. The alarm cannot be silenced by
the SILENT ALARM key. In this condition, the heating will be automatically off for the patient safety.
7) Hot air alarm

via red LED on the panel and a HOT AIR message on the display. The alarm can be silenced by the SILENT
ALARM key for a period of 15 minutes. By the end of such period, if the hot air condition persists the sound
alert is activated again.
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CAUTION
8) Cold air alarm

indication via red LED on the panel and a COLD AIR message on the display. The alarm can be silenced by
the SILENT ALARM key for a period of 15 minutes. By the end of such period, if the cold air condition persists
the sound alert is activated again.
CAUTION
9) Alarm of RN Sensor disconnected

This alarm is activated when the RN1 sensor is disconnected from the equipment (by the user or accidentally).
In this condition, the RN1 display will indicate the temperature and will not work in the RN mode, assuming the
AR mode automatically. In addition to the sound alert, there will be an indication via red LED on the panel and
a RN SENSOR DISCONNECTED message on the display. The alarm cannot be inhibited by the SILENT
ALARM key.
10) Alarm of RN sensor misplaced

This alarm is activated when the RN1 sensor loosen the patient’s skin. In addition to the sound alert, there will
be an indication via red LED on the panel and a RN SENSOR MISPLACED message on the display. The
alarm can be inhibited by the SILENT ALARM key for a period of 15 minutes. By the end of such period, if the
alarm condition persists, the sound alert is activated again.
11) Alarm of RN sensor failure

This alarm is activated when the RN1 sensor fails (component failure, short circuit or open circuit) In this
condition, the RN1 display will indicate the temperature and will not work in the RN mode, assuming the AR
mode automatically. In addition to the sound alert, there will be an indication via red LED on the panel and a
RN SENSOR FAILURE message on the display. The alarm cannot be inhibited by the SILENT ALARM key.

This alarm will be activated for RN mode only and will be activated whenever the difference between the
desired temperature set by the user and the newborn temperature is greater than 1.0°C. In addition to the
sound alert, there will be an indication via red LED on the panel and a HYPERTHERMIA message on the
display The alarm can be inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such
period, if the patient’s hyperthermia condition persists, the alarm will be reactivated.

and programmed temperature. In addition to the sound alert, there will be a visual indication via red LED on
the panel and the HYPOTHERMIA message on the display. The alarm can be inhibited by SILENT ALARM
key for a period of 15 minutes. At the end of such period, if the patient’s hyporthermia condition persists, the
alarm will be reactivated.

This alarm is activated when the temperature inside the dome exceeds 37.8 ° C (if the set point is lower than
37ºC), or 39.8°C (if the set point is greater than 37ºC). In addition to the sound alert, there will be an indication
via red LED on the panel and a OVERHEATING message on the display. The overheating alarm cannot be
silenced by SILENT ALARM key (except when out of risk range, less than or equal to 37ºC, if the set point is
lower than 37ºC, and less than or equal to 39°C, when the set point is greater than 37°C). These indications
will remain until the air temperature is lower, enabling again the resistance and thus keeping it. Whenever the
overheating alarm is activated the incubator automatically will turn off all servo control systems.
CAUTION
- For more safety, the electronic circuits and temperature sensor responsible for activation of such
alarm are independent of micro processed thermostat.
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HUMIDITY (OPTIONAL);
15) Alarm of low water level
This alarm will be activated whenever the humidification system is on and the water level in the tank is below
the minimum level. In addition to the sound alert, there will be an indication via red LED on the panel and a
LOW WATER LEVEL message on the display. The alarm can be inhibited by the SILENT ALARM key.
Whenever the low level alarm is activated, in this condition, the heating of the tank will be turned off and the
servo controlled humidification system will be disabled.
16) HIGH humidity alarm

above the desired value programmed by the incubator operator. In addition to the sound alert, there will be an
indication via red LED on the panel and a HIGH HUMIDITY message on the display. The alarm can be
inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such period, if the patient’s HIGH
HUMIDITY condition persists, the alarm will be reactivated.
17) LOW humidity alarm

below the desired value programmed by the incubator operator. In addition to the sound alert, there will be an
indication via red LED on the panel and a LOW HUMIDITY message on the display. The alarm can be
inhibited by SILENT ALARM key for a period of 15 minutes. At the end of such period, if the patient’s LOW
HUMIDITY condition persists, the alarm will be reactivated.
OXYGEN (OPTIONAL);
18) Alarm of O2 high level
This alarm is activated when the oxygen concentration inside the newborn compartment has a variance
greater than 3% over the programmed value In addition to the sound alert, there will be an indication via red
LED on the panel and an O2 HIGH LEVEL message on the display. The alarm can be inhibited by SILENT
ALARM key for a period of 15 minutes. At the end of such period, if the patient’s O2 HIGH LEVEL condition
persists, the alarm will be reactivated.
19) Alarm of O2 low level

This alarm is activated when the oxygen concentration inside the newborn compartment has a variance
greater than 3% over the programmed value In addition to the sound alert, there will be an indication via red
LED on the panel and an O2 LOW LEVEL message on the display. The alarm can be inhibited by SILENT
ALARM key for a period of 15 minutes. At the end of such period, if the patient’s O2 LOW LEVEL condition
persists, the alarm will be reactivated.
20) Alarm of O2 sensor failure

This alarm is activated when any failure (misreading, excessive variation, short circuit or open circuit) in one of
two oxygen sensors occur. In addition to the sound alert, there will be an indication via red LED on the panel
and an O2 SENSOR FAILURE message on the display. The alarm can be inhibited by SILENT ALARM key
for a period of 15 minutes. At the end of such period, if the patient’s O2 SENSOR FAILURE condition persists,
the alarm will be reactivated. If the alarm persists, call a service center.
21) Alarm of O2 calibration failure

This alarm will be activated whenever a failure in the calibration process of oxygen sensors occurs. In addition
to the sound alert, there will be an indication via red LED on the panel and an O2 CALIBRATION FAILURE
message on the display. The alarm can be inhibited by SILENT ALARM key for a period of 15 minutes. At the
end of such period, if the patient’s O2 CALIBRATION FAILURE condition persists, the alarm will be
reactivated.
22) Alarm of O2 sensor uncalibrated

This alarm indicates that the oxygen sensor needs to be calibrated so the servo control can be used activating
when the reading of one sensor exhibit excessive variation or after a period of 7 days after the last calibration
of the oxygen system. In addition to the sound alert, there will be an indication via red LED on the panel and a
O2 SENSOR UNCALIBRATED message on the display. The alarm can be inhibited by the SILENT ALARM
key (if the alarm is activated, calibrate the oxygen sensors).
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OXYMETRY (OPTIONAL);
23) Alarm of oxymetry sensor disconnected
This alarm will be activated whenever there is a valid measure of SpO2 and BPM and a disconnection of
sensor cable of the equipment (by the operator or accidentally). In addition to the sound alert, there will be an
indication via red LED on the panel and an OXYMETRY SENSOR DISCONNECTED message on the display.
The alarm can be inhibited by the SILENT ALARM key
24) Alarm of system failure.

This alarm will be activated whenever a valid measure of SPO2 and BPM and the sensor gets misplaced or
loosen it. In addition to the sound alert, there will be an indication via red LED on the panel and a SIGNAL
FAILURE message on the display. The alarm can be silenced by the SILENT ALARM key
25) HIGH SPO2 Alarm

This alarm will be activated when the percentage of SPO2 read by the oxymetry sensor is above the maximum
limit set by the user. In addition to the sound alert, there will be an indication via red LED on the panel and a
HIGH SPO2 message on the display. The alarm can be silenced by SILENT ALARM key for a period of 2
minutes. At the end of such period, if the HIGH SPO2 condition persists, the alarm will be reactivated.
26) LOW SPO2 Alarm

This alarm will be activated when the percentage of SPO2 read by the oxymetry sensor is above the minimum
limit set by the user. In addition to the sound alert, there will be an indication via red LED on the panel and a
LOW SPO2 message on the display. The alarm can be silenced by SILENT ALARM key for a period of 2
minutes. At the end of such period, if the LOW SPO2 condition persists, the alarm will be reactivated.
27) High heart rate Alarm

This alarm will be activated when the heart rate read by the oxymetry sensor is above the limit set by the user.
In addition to the sound alert, there will be an indication via red LED on the panel and a HIGH HEART RATE
end of such period, if the HIGH HEART RATE condition persists, the alarm will be reactivated.
28) Low heart rate Alarm

This alarm will be activated when the heart rate read by the oxymetry sensor is below the limit set by the user.
In addition to the sound alert, there will be an indication via red LED on the panel and a LOW HEART RATE
end of such period, if the LOW HEART RATE condition persists, the alarm will be reactivated.
29) Low perfusion Alarm

This alarm indicates that the patient perfusion is not enough for the sensor to read the oxymetry system. In
addition to the sound alert, there will be an indication via red LED on the panel and a LOW PERFUSION
end of such period, if the LOW PERFUSION condition persists, the alarm will be reactivated.
BALANCE (OPTIONAL):
30) Balance disconnected alarm
This alarm is activated when the balance sensor is disconnected from the equipment (by the user or
accidentally). This alarm indicates that the balance plate connector is disconnected. In addition to the sound
alert, there will be an indication via red LED on the panel and a BALANCE DISCONNECTED message on the
display. The alarm can be inhibited by the SILENT ALARM key.
31) Balance Overload Alarm

This alarm is activated when the balance exceeds the weight limit of 10kg, when this weight is exceeded, the
panel will indicate an alarm. In addition to the sound alert, there will be an indication via red LED on the panel
and a BALANCE OVERLOAD message on the display. The alarm can be silenced by the SILENT ALARM
key. At the end of this period, if it persists the overload condition in the balance, the audible alert will again be
triggered.
32) Balance Failure alarm

This alarm indicates that there was a failure in the weight reading and that may occur when one of the
weighing plate sensors are damaged or when there is a failure in the cable or connector (open or short circuit).
In addition to the sound alert, there will be an indication via red LED on the panel and a BALANCE FAILURE
message on the display. The alarm can be inhibited by the SILENT ALARM key.
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6.4.11 - CHECK OF ALARMS SYSTEM
Use the following procedure to check the alarms operation of the incubator model SCTI LINE 4.
heating is on.
front panel will fall. The Cold Air alarm should be activated as soon as the temperature indicated for
AR falls below 35.5°C. Close the dome after the alarm activation.
4- Connect the RN sensor on the side panel and select the RN mode (See item 6.3.2 - Use of RN mode).
5- Set the desired temperature of 37ºC for the RN mode. Position the RN sensor at 10cm away high on
no alarm activated.
8- Disconnect the RN sensor of the side panel and check the activation of the RN Sensor Disconnected
alarm.
9- Disconnect the RN sensor of the side panel and check the activation of the Disconnected alarm.
ventilation in the incubator tray. In the 15-120 seconds range, it shall operate the audible and visual
Air Circulation alarm. Let the air passage free.
11- Start the humidification system, setting the desired value to 90% of all humidity. Empty all
humidification system. Make sure the Low Water Level alarm is activated.
12- If there is a balance, place a weight exceeding 10 kg but not exceeding 12 Kg. Make sure the
Overload Balance alarm is activated.
13- Disconnect the balance sensor of the side panel. Check if the Balance Disconnected alarm is
activated.
14- In case of integrated pulse oxymetry, plug the oxymetry sensor on the side panel, place the sensor on
the finger, and be sure that the receiver and detector are not aligned. Check if the Signal Failure
alarm is activated.
15- Place the sensor and try to let the receiver and detector aligned to ensure the best possible signal,
increase the minimum in BPM mode. Check the High Heart Rate. Now change to reduce the
Maximum in BPM mode. Check the Low Heart Rate.
16- Repeat the process in SPO2 mode. Check if Low SPO2 and High SPO2 alarms are activated.
17- Disconnect the oxymetry sensor of the side panel. Check if the Oxymetry Sensor Disconnected
alarm is activated.
18- Disconnect the supply cable of the mains. Check if the Power Failure alarm is activated.
19- Press the Off key in the control panel.
center.
Note:
and test of some alarms can be done by the service center only. Send your transport incubator to periodic
reviews at intervals not exceeding 6 months.
- 107 -
7 - MAINTENANCE
After performing any maintenance procedure, make sure that the equipment and its alarms are in perfect
working conditions according to the procedure described in item - Verification of Alarms System, as control
module
Make sure that maintenance is always performed by qualified personnel, trained in the manufacturer and the
replacement parts used are original.
Refer to Technical Specifications or call the nearest service center for more detailed information on preventive
and corrective maintenance, spare parts, electric and electronic schemes and technical training.
CAUTION
- Only qualified personnel authorized by the manufacturer should perform the maintenance
procedures and review of the incubator.
- To avoid the possibility of burns while performing maintenance if the incubator, make sure that
the equipment is disconnected from the mains and the oxygen supply, and the air is closed or
disconnected.
7.1 - PREVENTIVE MAINTENANCE

The maintenance of the Newborn Incubator model SCTI LINE 4: allows the user and the small patient
the full operation of the equipment without any risk to both. For a better equipment conservation and increase
the patient safety, the incubator operator must follow the following procedure before the incubator receives a
new newborn, the incubator operator should follow the following procedures:
Perform cleaning and disinfecting in accordance with this guideline.
Check the battery through the following test: turn on the incubator and select a desired temperature value,
disconnect the power cable and check is there is a light indication for lack of energy and a sound alarm.
This sound and light indication should remain for a period of 3 minutes. After this period, reconnect the
cable to the outlet and see if the incubator gets back to work at the same temperature display selected at the
beginning of the test. If these conditions are not observed call an authorized technician to perform the battery
replacement.
Inspect the acrylic dome covers with special attention to the locking mechanism which should keep the
covers closed even after the application of force from inside out of the dome.
Check the incubator stability trying to move it with the brakes of the four casters.
Check if there are no issues with the latch lock of the dome, opening and closing it.To check the alarm,
check item - Operation of alarms as control module
Bed
The incubator bed should be verified every six months to ensure its correct operation. The technician must
perform the following procedure:
- Open the dome cover and pull the bed out. Check if the tray handle is not stacked and crashing at the end.
- Check if the bed has no deformation or broken parts.
- Check if the mattress is in good condition, with a plastic cover and no rip or sewn pieces.
Support
The incubator support should be verified every six months to ensure its correct operation. The technician must
perform the following procedure:
- Check if all parts are securely fixed. Check the screws fixation.
- Check if the casters’ operation are spinning freely and the brakes are working properly.
Body
- Check if the incubator box has normal use conditions. There shall be no damaged parts, defective paint or
any abnormality.
Dome
- Check if the incubator dome has normal use conditions. It should not be cracked or broken parts.
Periodic review
- It is recommended that the incubator receives periodic reviews of calibration every 6 months at a service
center authorized by Olidef
- 108 -
7.2 - PERIODIC MAINTENANCE
The equipment operator must check the following items to ensure the correct operation of the transport
incubator.
EXAMINED PARTS MAINTENANCE PERIOD EXECUTION

RN sensor Every time the equipment is used User
Auxiliary light bulb Every 2 months Technician
Casters Every 2 months User
Portholes closing Every 2 months Technician
Opening and locking of the dome front cover Every 2 months Technician
Physical state of the mattress Every time the equipment is used User
Trendelenburg / Reverse Mechanism Every 2 months Technician
Dome fixation lock Every 2 months Technician
Latch lock for intensive care Every 2 months User
Dome trims / portholes Every 6 months User
Solenoid valve Every 6 months Technician
Oxygen hoses Every 12 months User/Technician
Oxygen O-ring Rings Every 12 months Technician
Air filter Every 3 months User
Particle retention filter Every 3 months User
Tank Every 12 months Technician
Parts replacement
It is recommended the periodic replacement of some parts suffering wear according to the terms described in
the table below. The replacements must be made by trained personnel. Always use parts provided by Olidef or
its authorized service centers.
Parts replacement TERM PERFORMER
Auxiliary light bulb 12 months Technician
High pressure hose 12 months User
Sealed battery 12V - 1,3Ah of support with height
18 months Technician
setting
Air filter 3 months User
Particle retention filter 3 months User
O-ring Rings of oxygen valves 12 months Technician
Iris sleeve 6 months Technician
Wrist sleeve 6 months Technician
AR buffer 12 months Technician
Tube passage 12 months Technician
Mattress 6 months User
Mattress cover 12 months User
Oxygen cell 12 months Technician
8,4V battery 12 months Technician
Clock battery (CR2032 Lithium) 18 months Technician
CAUTION
- Batteries should only be replaced by technician certified by the manufacturer.
- 109 -
7.2.1 - AIR FILTER EXCHANGE
To replace the air filter, remove the knob (A) that locks the cover, then remove the cover (B) to replace the
filter (C).
A- Knob
B - Filter Cover
C - Filter
D - Filter basin
E - Air conductor duct
Figure 167 - Air filter replacement Figure 168 - Air filter (exploded view)
7.2.2 - EXCHANGE OF AIR FILTER OF THE PASSIVE OXYGEN VALVE

To replace the air filter (A), unscrew the valve inlet nozzle until the end, remove the O-ring (B). Replace the air
filter and return it to its original position as shown in Figure 169.
Figure 169 - Air filter replacement - passive valve
7.2.3 - EXCHANGE OF AIR FILTER OF THE LIMITING OXYGEN VALVE

Figure 170 - Air filter replacement - limiting valve
- 110 -
7.2.4 - EXCHANGE OF AIR FILTER OF SERVO CONTROLLED OXYGEN VALVE
Figure 171 - Air filter replacement - O2 valve
7.2.5 - FUSE EXCHANGE

• MC1
- Insert a screw key into the holder fuse slot and turn left to unlock the cover as shown in Figure 172.
Figure 172 - Fuse port - MC1
- Remove the fuse out and insert the new one as Figure 173.
Figure 173 - Fuses 3A - Type F 20 AG
-Put the cover and turn right to lock it on place

- 111 -
• MC2 and MC3
- Insert a screw key into the holder fuse slot and turn left to unlock the cover as shown in Figure 174.
Figure 174 - Fuse port - MC2/MC3

- Remove the fuse out and insert the new one as Figure 175.
Figure 175 - Fuses 10A - Type F 20 AG
-Put the cover and turn right to lock it on place
• LC5 Balance
-Unscrew the cover, remove the fuse out and insert the new one as Figure 176.
Figure 176 - Fuse 0,6 Type F - 20 AG
- Screw the cover in place.
- 112 -
• Halogen Phototherapy
- Insert a screw key into the holder fuse slot and turn left to unlock the cover as shown in Figure figura177.
- Remove the fuse out and insert the new one.
Figure 177 - Fuses for 127 V – 2A Type F – 20 AG and 220 V – 1A Type F – 20 AG
-Put the cover and turn right to lock it on place.
Environmental Protection
Disposal
If there is need to disposal of equipment or its parts and they do not have a destination defined by the
customer, the item must be sent to the manufacturer or nearest service center for disposal according to
current law.
Rechargeable batteries used in the SCTI LINE 4 incubator have limited lifetime. After replacement, send the
damaged battery to the manufacturer or nearest service center. Do not disposal the material in the common
trash; the batteries have toxic and heavy metals in the composition.
CAUTION
- Disposal of batteries should be performed in accordance with the current laws of the country.
8 - CLEANING AND DISINFECTION

8.1 - CLEANING
CAUTION
- To avoid the possibility of burns or electric discharges occur during the process of cleaning and
maintenance, ensure that the SCTI LINE 4 Incubator is disconnected and make sure the heating
element is not hot.
- Before starting the cleaning and maintenance procedures make sure that the oxygen supply is
closed or disconnected from the incubator. Danger of explosion and fire during cleaning or
maintenance in an environment enriched with oxygen
Cleaning the SCTI LINE 4 Incubator must be made upon initial receipt, off/out of use, return of maintenance,
after the equipment usage (patient withdrawn) or as procedures for inner cleaning and disinfection following
the sequence below:
• Use a soft and clean cloth moistened in water and mild soap.
• Remove dust from the equipment plastic and metal surfaces.
• Clean the monitor support, the serum support and the incubator support.
• Clean the entire body surface of the incubator using a moistened cloth and mild soap.
• RN AND OXIMETRY SENSORS

1. Discard the adhesive used for fixation in the proper location.
2. Clean the sensor with a soft cloth moistened with water and soap or isopropyl alcohol.
3. Remove any existing adhesive residue on the sensor.
4. Do not spray any liquid on the sensor.
5. Remove the cleaning residue of the sensor with a soft cloth moistened with water.
6. Allow the sensor to dry before using it again.
- 113 -
Note:
- The oxymetry and RN temperature sensors should not be immersed in water or any kind of solution. Do not
use abrasive or corrosive products to clean the sensors.
• MATTRESS
1. Move the dome back until it locks it in the pin.
2. Remove the mattress from the inside of the RN compartment as shown in Figure 179.
Figure 178 - Acrylic dome Figure 179 - Opened acrylic dome

3. Remove the mattress foam of its plastic cover as shown in Figure 180.
Figure 180 - Mattress Cover

4. Wash the foam and the plastic cover with a detergent and disinfectant solution appropriate and properly
diluted.
5. Rinse the parts in running water removing any residue of solution used for cleaning the material.
6. Let it dry at room temperature.
7. Replace the foam inside its plastic cover.
8. Replace the mattress in the SCTI LINE 4 incubator bed.
• RN COMPARTMENT
To clean the internal RN compartment follows the procedure below:
1. Move the dome back until it locks it in the pin as figure 181.
Figure 181 - Closed dome

- 114 -
2. Remove the RN bed.
Figure 182 - Opened dome
3. Remove the platform.

4. To remove the platform, grab the side handles and pull up as shown in figure 183.
5. Remove the air conductor pulling up as Figure 184.
Figure 183 - Platform Figure 184 - Air conductor

6. The basin and cover for sterilization can be cleaned with a moistened cloth and mild soap.
7. If the equipment has balance, wipe it with a cloth moistened in water and mild soap.
8. Then dry the parts with a clean cloth or paper towel.
9. Replace the air conductor and the platform in the basin.
10. Replace the patient bed in its original position.
Figure 185 - Closing the dome

- 115 -
11. To unlock the dome remove some weight, then pull the pin out to unlock it as shown in Figure 186.
Figure 186 - Unlocking the dome

12. Close the dome.
• DOME
1. To remove the inner dome of the dome port, turn latches of CI located at the port ends as shown in Figure
187.
Figure 187 - CI latch

2. Open the dome port at an angle of 90º. Grab the dome port with one hand and with the other pull the inner
cover through the hole (A) as Figure 188.
Figure 188 - Unlocking the port inner dome
- 116 -
3. Pull the inner cover up.
Figure 189 - Port inner dome

4. To remove the inner dome, move the dome set back until it locks.
Figure 190 - Removing the inner dome
5. Move up to unlock on both sides then carefully remove the inner dome out as shown in figure 191. If the
equipment is assembled with the control module MC3, it will be necessary to remove the sensor module
before removing the inner dome.
Figure 191 - Inner dome removed

- 117 -
6. To remove the inner dome with the control module MC3, turn the limiting screw until the end, and then
remove the module as shown in Figure 192.
Figure 192 - Removing sensors’ module

7. Clean the incubator dome with a cloth moistened in water and mild soap.
8. The inner dome can be cleaned using the same process or may be washed in running water.
9. Then, dry the parts with a clean cloth or paper towel.
10. Replace the inner dome to its original position.
11. Then, bring down the dome set and replace the inner cover in its original position.
• WATER TANK:
1. Remove the water tank from the incubator as shown in Figure 193.
Figure 193 - Water tank

2. Pull the tank drawer and remove the cover as shown in Figure 194.
Figure 194 - Water tank cover

3. The tank can be washed in running water or clean with a cloth moistened in water and mild soap.
4. Then dry the parts with a clean cloth or paper towel.
5. Return the tank to its original position.
- 118 -
• CONTROL MODULE
1. Before removing the control module, remove all cables connected to the side panel. Pull the panel latch
located on the control module and pull the tab (A) located on the front side as shown in Figure 195:
Figure 195 - Latch of control module
2. Remove the control module of the incubator.

3. Clean the front panel of the module using a moistened cloth.
4. Clean the metal surfaces of the module using a dry cloth. The connectors on the side panel should not be
wet.
5. Clean the rear side, including the fan, heater and sensors using a moistened cloth.
6. If available, you can use the disinfection tank to facilitate cleaning of components of the module rear side.
Thus, initially, put water and a small amount of detergent in the disinfection tank.
Figure 196 - Disinfection tank
7. Then, dip the rear side of the module in the tank as shown in Figure 194, and maintain in it for 10 minutes.
8. Remove the module from the disinfection tank
9. Replace the water of the disinfection tank.
10. Dip the module rear side into the tank again.
11. Wait for 3 minutes and remove the control module from the tank.
12. Dry the module rear side and its components using a clean dry cloth or paper towel.
13. To replace the control module in the incubator, push it to its normal position until you hear the "click" of the
latch.
- 119 -
8.2 - DISINFECTION
In cases which the incubator has been used for a child with infectious disease, the disinfection must follow a
more strict process. However, due to be a not critical subject, there is no need for sterilization of the
equipment or its parts, being sufficient the disinfection only.
For this, follow the equipment cleaning on the indications of Item 8.1 - Cleaning. Then, after drying the parts,
use a dilute solution of quaternary ammonium that has spectrum of great action for disinfection; however, do
not leave residual susceptible to get in contact with the newborn body and may cause any toxic action . Apply
the solution with a clean cloth over the mattress, bed, RN sensor (do not leave the solution gets into contact
with the RN sensor plug), RN compartment and fan.
The disinfection of acrylic parts, never use products made from alcohols or ethers, due to this liquid may
damage such material.
CAUTION
- Do not autoclave the foam or the mattress cover.
- Do not use solvents or abrasive cleaners to clean the surfaces of the SCTI LINE 4 incubator.
- Do not expose the acrylic or plastic surfaces under direct radiation from germicidal bulbs. The
ultraviolet light can cause drying of these materials.
-Do not autoclave or sterilize any part of the incubator with gas.
- For cold sterilization, make sure the product that will be used can be used with plastic and metal
materials (chrome and painted).
- For immersion in liquids, some chemicals can be harmful to plastics; in case of doubt, consult the
supplier of such products.
9 - TROUBLESHOOTING
The troubleshooting table indicates to the user a series of generic occurrences, its causes and possible
measures to be taken for possible troubleshooting. If such information is not sufficient to correct the failure, the
Newborn Incubator model SCTI LINE 4 must be submitted for review at the nearest authorized service center.
FAILURE CAUSE SOLUTION

Incubator does not turn • Main key and battery • Turn the main key on the control module and press
on unloaded POWER on the front panel
• Access door open • Close the access doors
The air temperature • Lack of power • Check the power supply and the battery voltage
does not increase
• Resistance is not heating • Defect in resistance
• Access door open • Close the ports

Low oxygen • Inlet tube for oxygen leaking • Change the tube
concentration
• Oxygen valve uncalibrated • Make the calibration and measurement
• Check the RN sensor position

• Check the desired temperature
Alarms of
hypothermia and • Powered constantly • Check the patient's temperature with a clinical
hyperthermia thermometer and compare with the value read by the
incubator. If the values are not consistent, call an
authorized service center
• The RN sensor plug is
• Firmly insert the RN sensor plug in the control
poorly connected
The temperature module
• The RN sensor is damaged
value indicated for the • Send it to the Technical Support
• The RN sensor or the sensor
RN is incorrect • Place the RN sensor and the fixation adhesive
fixation adhesive are placed on
correctly (see item 6.2 of this guide)
the patient incorrectly
• Firmly insert the sensor plug on the air sensor in the
Display indicating • Air sensor disconnected
incubator
Error • Air sensor presenting failure
• Send it to the Technical Support
- 120 -
10 - WARRANTY
The Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda assures to the owner of the Newborn
Incubator SCTI LINE 4 warranty against any defect in material or workmanship that it is submitted within
twelve months (12) from the purchase date by the first acquirer.
The warranty responsibility is limited to repair or replacement of defective parts and manufacturing and setting
repairs that may be necessary to operate the unit within its specifications provided it is performed at the
company headquarters as Avenida Patriarca, 2223 - Ribeirão Preto or service centers of Olidef with expenses
and risks of transport and packaging by the owner.
It is excluded from this warranty the defective parts by wear such as power cable, mini resettable circuit
breakers, bulbs, seals, etc. This warranty is void if the equipment, at Olidef criteria, has suffered damage by
accident, fall, or show signs of sets or attempts or repair by unauthorized persons.
Any change or extension of warranty, and strict conditions of this term, will only be valid when taken in writing
directly by Olidef.
- 121 -

User&#39;s Manual Incubadora SCTI Line 4

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INCUBATOR FOR NEWBORN

Model: SCTI LINE 4

Technical Responsible: Clayton André dos Santos

Representative in the European community: OBELIS S.A.

Figure 1 – Incubator for Newborn SCTI LINE 4

1.2 - PRODUCT DESCRIPTION

1.3 - PHYSICAL PRINCIPLES

Figure 2 – Isometric view of Incubator for Newborn model: SCTI LINE 4

1 Control Module 8 Porthole w/ touch of elbow (5x)

Figure 3 – Control module - 1

1.4.3 - BED WITH MATTRESS

Figure 5 – Mattress bed

Figure 6 – Mattress bed composition

Parts of the newborn bed:

1.4.4 - BED TILT – CONVENTIONAL SYSTEM

Figure 7- Activation of the tilt system

Figure 8 - Incubator body

Figure 9 – Inner basin

1.4.6 – CONVENTIONAL SUPPORT

1.4.7 - AIR FILTER

Figure 11 – Air filter location

1.4.8 - WATER LEVEL INDICATOR- PASSIVE HUMIDIFICATION

1.4.9 - LIMITING OXYGEN VALVE

Figure 13 – Limiting valve location

1.4.10 - RN SENSOR (CODE 520041143030)

1- Skin Sensor (encapsulated with biocompatible titanium, according

1.5 - OPTIONALS, ACCESSORIES AND CONSUMPTION MATERIAL

1.5.1 - CONTROL MODULE – 2 (MC2)

Figure 15 - Control module - 2

Figure 16 - Control module - 3

1.5.3 - SERVOCONTROLLED SYSTEM FOR HUMIDITY

Figure 19 – humidity drawer

1.5.4 - SERVO CONTROLLED SYSTEM FOR OXYGEN

Description Olidef Code

Figure 22 – MC3 Display panel - Oxymetry

Figure 23 - Oxymetry sensor 1 Figure 24- Oxymetry sensor 2

1.5.6 - EXTENDER CABLE FOR OXIMETRY SENSOR (CODE 2650010403)

Figure 25 - extender cable

1.5.7 - Y-TYPE OXIMETRY SENSOR (CODE 2650010443)

Figure 26 - Sensor type Y

1.5.8 - INTEGRATED BALANCE

Figure 27 – Control Module Panel - 2

Figure 30 – Panel da balance LC 5

1.5.10 - SERIAL COMMUNICATION SYSTEM

1.5.11 - DOME WITH DOUBLE DOWEL

Figure 31 – Dome with double dowel

1.5.12 - DOME WITH FRONT AND REAR ACCESS COVER

Figure 32 - Dome with front and rear access cover

1.5.14 - INTERNAL DOME

1.5.15 - INTERNAL DOME W/ REAR PORT

Figure 35 - Internal dome w/ rear port

1.5.16 - MONITOR SUPPORT

1.5.17 - LOWER SERUM SUPPORT

Figure 37 - Lower serum support

1.5.18 - HIGHER SERUM SUPPORT

1.5.19 - BALANCE SUPPORT

Figure 39 - Support for assembled balance

1.5.20 - AUXILIARY LIGHTING

Figure 40 - Auxiliary lighting

1.5.22 - AUXILIARY OUTLETS

Figure 42- - Auxiliary outlets

Figure 43 - Drawer for x-ray

1.5.24 - SYSTEM OF BED CONTINUOUS TILT

Figure 44 - Activation of continuous tilt system

User's Manual Incubadora SCTI Line 4

User's Manual Incubadora SCTI Line 4