Operation Manual

OPERATION MANUAL CARMEL SERVOVENTILATOR Equipment Code: 201050035 No. of MS Register: 10229820091 Manual Code: 204010258_002 Date: (JUL/2006)

This Operation Manual contains the information necessary for the correct utilization of the CARMEL Servoventilator.

Manufacturer:
K. TAKAOKA Indstria e Comrcio LTDA. Av. Bosque da Sade, 519 So Paulo SP CEP: 04142-091 Tel: (55 0xx11) 5586 1000 Fax: (55 0xx11) 5589 7313 Web site: www.takaoka.com.br e-mail: kt@takaoka.com.br CGC: 61.489.381/0001-09 I.E.: 103.735.350.115 For suggestions, questions or complaints: Call Center: (55 0xx11) 5586 1010

Product Register in the Ministry of Health:

Commercial Name: CARMEL Servoventilator Number of the Register in the Ministry of Health: 10229820091

Product Classification:
NBR IEC-60601-1/97 (1994) & Correction no. 1 (1997) & Amendment no. 1 (1997) (Electromedical Equipment Part 1: General Safety Prescriptions) NBR IEC 60601-2-12/2004 (specific prescriptions for the safety of lung ventilation equipment in medical utilization Equipment Class 1 Internally Energized) NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General Safety Prescriptions 2. Collateral Standard: Electromagnetic Compatibility Prescriptions and tests) Equipment Class 1 Internally Energized Type B IPX0 Continuous Operation

Responsible Technician:
Eng. Mauricio Chiarioni CREA: Register no. 5061714921

Manual Code: 204010258_002

Manual Code: 204010258_002

Product Installation Form EQUIPMENT: ___________________________ Code: _____________ Serial Number: _______________
DESCRIPTION 1 2 3 4 5 6 7 8 9 10 COMPONENTS CODE SERIAL NUMBER

BILL OF SALE: Original K.TAKAOKA [ ] YES _____________________ [ ] NO ______________________ Bill Number * Dealer Name ENTITY: Company Name: ______________________________________C.N.P.J*.: __________________________ Address: _______________________________________________________________________________ City: ________________________________________ State: __________MAIL CODE: ________________ Person responsible for the information*:_________________________ Position: ______________________ Sector: ________________________ Tel*.:____________________ email: __________________________ (*) Mandatory Fields YOUR OPINION:
1. Was the product(s) delivery made in time regarding the agreed upon date? 2. Were the product(s) and component(s) according to the order? 3. Was the packaging in any way damaged? 4. Was there any problem to install the equipment? 5. Is the equipment and/or components working properly? 6. Was there any problem to connect the components, tubes and cables? 7. Is the bill of sale data correct, regarding your data, amounts, product description, quantities and payment conditions? 8. Please enter any additional comment: Yes Yes Yes Yes Yes Yes Yes No No No No No No No

Installation performed by: ___________________________ Date ____/ ____ /_____ Sig.: ______________ (Technician Name) Dealer: _________________________________________ Date ____ / ____ / _____ Sig.: _____________ Please send this form to the Fax No. (55 0xx11) 5589 8072 or by registered mail to K. TAKAOKA WARNING: THE WARRANTY PERIOD WILL START UPON THE CONFIRMATION OF THE INFORMATION CONTAINED IN THIS TERM. THIS TERM SHALL BE SENT WITHIN A MAXIMUM TIME OF THIRTY (30) DAYS, AS STATED IN THE OPERATION MANUAL If there is any doubt or you need more information please contact: SAC (55 0xx11) 5586 1010

Manual Code: 204010258_002

Manual Code: 204010258_002

CONTENTS

DEFINITIONS ......................................................................................................................................................................................9 THE COMPANY .................................................................................................................................................................................10 1 2 2.1 3 3.1 4 4.1 4.2 4.3 4.4 4.5 5 5.1 5.2 5.3 IMPORTANT NOTES ..............................................................................................................................................................12 GENERAL DESCRIPTION......................................................................................................................................................16 Ventilation Monitor ........................................................................................................................................................18 TECHNICAL SPECIFICATIONS .............................................................................................................................................19 Ventilation Monitor Specifications .................................................................................................................................22 OPERATION PRINCIPLE.......................................................................................................................................................24 Flow Servo-Valves ........................................................................................................................................................24 Electronic Mixer ............................................................................................................................................................25 Electromagnetic Valve..................................................................................................................................................25 Flow and Volume Measurement ...................................................................................................................................26 Oxygen Measurement...................................................................................................................................................26 CONTROLS AND COMPONENTS.........................................................................................................................................27

Components List...........................................................................................................................................................27 Optional Items ...............................................................................................................................................................28 Front View.....................................................................................................................................................................29 5.3.1 LCD Monitor............................................................................................................................................................ 30 5.3.2 Control Panel........................................................................................................................................................... 30 5.4 EASY TOUCH Button ...................................................................................................................................................30 5.5 Front Connection Panel ................................................................................................................................................30 5.6 Rear View .....................................................................................................................................................................32 5.7 Heated Humidifier.........................................................................................................................................................34 5.8 Expiration valve.............................................................................................................................................................35 5.9 Drains ...........................................................................................................................................................................36 5.10 Nebulizer (optional).......................................................................................................................................................36 5.11 TGI - Tracheal Gas Insufflation.....................................................................................................................................37 5.12 Battery..........................................................................................................................................................................38 5.13 Movable Base...............................................................................................................................................................38 6 ASSEMBLY AND PREPARATION OF THE CARMEL ...........................................................................................................39 6.1 6.2 6.3 6.4 6.5 Assembly of the CARMEL .............................................................................................................................................39 Power Source...............................................................................................................................................................40 Respiration loop............................................................................................................................................................41 Flow Sensor..................................................................................................................................................................43 Cell/O2 Sensor..............................................................................................................................................................44 6.5.1 Calibration before using the O2 Sensor.................................................................................................................... 45 6.5.2 After calibrating the O 2 sensor................................................................................................................................. 45 CONTROL PANELS ...............................................................................................................................................................47 7.1 8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 9 9.1 9.2 10 Control panel.................................................................................................................................................................47 Configuration of the Ventilation Parameters.......................................................................................................................49 Self-test Screen............................................................................................................................................................49 Initialization Screens.....................................................................................................................................................49 Main Screen..................................................................................................................................................................53 Messages .....................................................................................................................................................................53 Monitoring Functions.....................................................................................................................................................55 Graphics Window..........................................................................................................................................................55 Trend Screen (Graphic) ................................................................................................................................................56 Database......................................................................................................................................................................57 OPERATION ...........................................................................................................................................................................59 Initial Procedures and Tests..........................................................................................................................................59 Adjustment of the Ventilation Parameters.....................................................................................................................60 ALARM SYSTEM ....................................................................................................................................................................65

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10.1 Alarm Priority Levels.....................................................................................................................................................65 VENTILATION MODES ...........................................................................................................................................................68 11.1 11.2 11.3 11.4 11.5 Mandatory and Spontaneous Cycles ............................................................................................................................68 Selection of the Ventilation Modes ................................................................................................................................69 VCV - volume-controlled ventilation..............................................................................................................................69 PCV - pressure-controlled ventilation............................................................................................................................70 PLV pressure-limited ventilation..................................................................................................................................71

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11.6 PCV/AV - volume ventilation ensured by pressure control..........................................................................................72 11.6.1 Initialization sequence - PCV/AV ........................................................................................................................... 73 11.7 SIMV/V - synchronized intermittent mandatory ventilation with volume control.............................................................73 11.8 SIMV/P - synchronized intermittent mandatory ventilation with pressure control.........................................................74 11.9 BIPV - spontaneous ventilation with two pressure levels.............................................................................................75 11.10 CPAP - ventilation with continuous positive pressure in the aerial passages................................................................76 11.11 PSV - pressure support ventilation................................................................................................................................76 12 SPECIAL FUNCTIONS ...........................................................................................................................................................78 12.1 Inspiration Pause and Expiration Pause.......................................................................................................................78 12.2 Auto-PEEP Measurement.............................................................................................................................................78 12.3 100% of Oxygen...........................................................................................................................................................78 12.4 Relief.............................................................................................................................................................................78 12.5 Measurement of the Tobin Index (iT) ............................................................................................................................78 12.6 Measurement of the P0.1 Occlusion Pressure of the Aerial Passages .........................................................................78 13 CLEANING AND STERILIZATION .........................................................................................................................................79 14 MAINTENANCE......................................................................................................................................................................84

14.1 Internal Rechargeable Battery......................................................................................................................................85 14.2 Fuse Replacement........................................................................................................................................................85 14.2.1 Fuse replacement instructions (built-in in the outlet)................................................................................................ 85 14.2.2 Fuse replacement instructions (individual)............................................................................................................... 85 15 TROUBLESHOOTING ............................................................................................................................................................86 15.1 Message in the Monitor.................................................................................................................................................86 15.2 Occurrences..................................................................................................................................................................87 16 MEASUREMENT METHODS ..................................................................................................................................................88 16.1 16.2 16.3 16.4 16.5 16.6 16.7 16.8 17 18 19 Volumes........................................................................................................................................................................88 Frequency.....................................................................................................................................................................88 I:E Ratio ........................................................................................................................................................................88 Inspiration and Expiration Time .....................................................................................................................................89 Maximum, Medium, Plateau and PEEP Pressure.........................................................................................................89 Resistance....................................................................................................................................................................89 Complacency................................................................................................................................................................90 Inspiration work.............................................................................................................................................................90

SYMBOLOGY .........................................................................................................................................................................91 EMERGENCY ACTIONS ........................................................................................................................................................96 WARRANTY TERM.................................................................................................................................................................97

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DEFINITIONS

Caution
Alerts the user about the possibility of injury, death or other serious adverse reactions associated to the bad use of the equipment.

Warning
Alerts the user about the possibility of problems with the equipment associated to bad use, such as equipment malfunction, equipment failure, damaged equipment or damages to third-party property.

Note:
Highlights an important information

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THE COMPANY
A K. TAKAOKA is a company dedicated for more than 48 years to the segment of hospital equipment, always in close cooperation with the medical class. It acts mainly in the areas of Anesthesia, Intensive Care, Monitoring and Oxygen Therapy and is proud of having achieved a leading position in the market, it counts with an extensive line of products. It holds as one of its priorities the permanent investment in the research and development of new ideas and solutions. It is well known for the constant introduction of technological advances and industrial innovations to its product line, comparable to the main domestic and international industries of the segment. The company designs and manufactures with the help of sophisticated equipment the majority of the components used in its products, which are submitted to a strict quality control. It is also concerned in providing a high level of support to all users by means of its Sales and Technical Assistance departments. It counts with distributors all around the national territory and is also present in the international market. K. TAKAOKA has therefore achieved, along the years, the confidence of its clients on its strict quality standards and on the high efficiency of its products and services. Vision: To become a global company. Mission: To become a national leader in the segments of anesthesia apparatus, lung ventilators, vital signal monitors and oxygen therapy, thus contributing to the preservation of life, offering high technology and the best service to our clients. Quality Policy: Continually improve our PRODUCTS, SERVICES and PROCESSES, involving our COLLABORATORS and SUPPLIERS in obtaining the satisfaction of our CLIENTS and SHAREHOLDERS.

K. TAKAOKA IND. E COM. LTDA. Av. Bosque da Sade, 519 So Paulo - SP - CEP: 04142-091 Tel: (55 0xx11) 5586-1000 Fax: (55 0xx11) 5589-7313 E- mail: kt@takaoka.com.br Site: http://www.takaoka.com.br

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Figure 1: CARMEL Servoventilator

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1
Note:

IMPORTANT NOTES

This Operation Manual is destined to the commercially available model of the CARMEL Servoventilator. The several components possibly compatible with the CARMEL are clearly highlighted in the text as optional items.

The CARMEL Servoventilator is a medical apparatus designed to join the most advanced technology to an easy to use apparatus, which shall be only operated by qualified professionals specifically trained on its utilization. The warnings and recommendations described below shall be carefully observed.

Biocompatibility

v According to ISO 10993-1 this equipment is classified as a device without direct and/or indirect contact with the patients body,
therefore it is not included in the scope of this standard (Clause 4.2.1).

Ventilation

v When turning the ventilator on, adjust the volume per kg and the weight of the patient so the ventilator will display the current
calculated volume. Select the initial mode and the ventilator will suggest the parameter value.

v When the ventilation is limited by the control of the inspiration pressure limit, in the VCV, SIMV/V and PCV/AV
condition displayed on the monitor through the message LIMITED PRESSURE.

modes, the

value of the actual volume supplied to the patient is lower than the one adjusted in the current volume control, being such

v After starting the ventilation, please check whether the ventilation parameters shown on the monitoring display are adequate. v Check the proper adjustment of all the alarm limits. v To ensure that all the water condensed in the respiration loop returns to the drains and does not reach the patient, the tube
support shall be placed close to the intermediate Y piece and in a position lower than the patients mouth.

v In order to avoid an accidental disconnection or gas leaks in the respiration loop, all connections shall be firmly secured. Close
tightly the threaded lid of the Heated Humidifier.

v Check frequently the tightness of the endotracheal tube connection. v Do not use antistatic hoses or electrically conductive tubes. v When the ventilator is in use, an alternate ventilation means shall be available. v In case of failure of the pneumatic and power sources the ventilator will allow spontaneous ventilation with a resistance of 0.45
cmH2O/lpm, 0.25 cmH2O/lpm and 0.50 cmH2O/lpm with flows of 60 lpm, 30 lpm and 5 lpm respectively.

Oxygen Analyzer

v The Oxygen Analyzer shall be calibrated in ambient air (21% of O ) or pure Oxygen (100% of O ) before each utilization of the
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CARMEL Servoventilator.

v The Oxygen Analyzer shall always be kept in a hermetically closed package when not in use, to prevent the reduction of its
service life.

v Use only the Oxygen Analyzer specified by K. TAKAOKA.

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Flow Sensor

v Connect the type of flow sensor most adequate to the selected patient weight (adult or infantile). v Observe the correct assembly position of the flow sensor in the respiration system. v Use only the flow sensor supplied by K. TAKAOKA for the CARMEL Servoventilator. v When using the ventilator, check the flow sensor for cleanlinessfrequently.
Power Source and Internal Battery

v Connect

the power cable only to a properly grounded outlet, approved for hospital use. The plug shall have three

Nema 5-15P pins (item 6.2).

v Keep the internal battery always charged, so the ventilator will continue to operate even in case the electric network fails.
Therefore, the ventilator shall be left constantly connected to the electric network , even when turned off, to keep the internal battery fully charged.

v Recharge the battery after using the ventilator while not connected to the electric network, to prepare it for the next
utilization period.

v Perform a complete battery recharge when the ventilator was not in use and disconnected from the network for a period longer
than 20 (twenty) days.

v The Heated Humidifier is powered neither by the ventilator internal battery nor by the 12 Vdc source. v If the internal battery is powering the ventilator and the high-priority alarm of BATTERY LOW is activated, the ventilator must
then be immediately connected to the electric network.

v If there is any doubt about the integrity of the installation of the protection ground conductor, the ventilator shall be operated
from the internal power source.

v The connection of other equipment to the auxiliary network outlet may increase the current drain through the patient up to
values that exceed the allowable limits, in the case of a defective protection ground conductor.

v When the NETWORK (1) visual indicator (on the keyboard) is off, an urgent action is required to reestablish the ventilators
input voltage, because there is the imminent risk of a ventilator stop.

v The detachable network cord (power cable) must be fastened with a clamp ring to avoid accidental disconnection. v The internal rechargeable battery can only be replaced by K.TAKAOKAs authorized Technical Assistance.
Miscellaneous

v The ventilator shall be submitted to an annual inspection carried out by a technician authorized by K. TAKAOKA, for re-calibration. v Check whether the ventilator is correctly configured and if the alarms are properly adjusted before using the equipment.

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v When filling the glass of the Nebulizer, do not exceed the maximum medicine capacity in the reservoir. Do not leave it
connected when not in use.

v Do not press any key with surgical instruments or tools. Use only your fingertips to press the keys. Sharp or hard objects may
damage the keys.

v The CARMEL Servoventilator is not approved for use with flammable anesthetic agents. v Establish an adequate cleaning and sterilization routine for the ventilator components (Chapter 13). v Observe constantly if the inspiration pressure manometer is displaying adequate values. v Keep the patient under constant observation. Observe frequently his/her lung expansion and free expiration. v All parts of the equipment in contact with patient fluids (as respiration loops, flow sensors, expiration valve diaphragms, etc.) may
be potentially contaminated after use. If considered semi-critical, they must be submitted, before discarding (at the end of their service life), to a high-level disinfection process or sterilization, or they must be discarded as potentially infected hospital garbage.

v The applied parts are defibrillation-proof, with exception of the temperature sensor cable, which must be removed from the
work area (because the patient may get burned) when the defibrillator is used close to the ventilator.

v All the applied parts of the ventilator are built of inert and non-toxic material, to prevent sores or allergy in the patient. v Please read this Operation Manual very carefully, in order to use the equipment correctly and to take the maximum advantage
of all its features.

v Please also read the Heated Humidifier 6060 Operation Manual, supplied together with the CARMEL Servoventilator. v Any necessary repair in the ventilator shall only be carried out by qualified technicians duly authorized by K. TAKAOKA. v The operation of this equipment is not affec ted when used close to other equipment, as high-frequency surgical equipment
(diathermy), defibrillators or short-wave therapy equipment. An accredited laboratory carried out electromagnetic compatibility tests.

v This equipment does not emit electromagnetic waves that might interfere with the operation of nearby equipment. An
accredited laboratory carried out electromagnetic compatibility tests.

v In this manual and in the ventilator, the pressure unit shown is in centimeters of water (cmH O) and not in Pascal (Pa), its
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corresponding unit in the International System (IS). Being 1 Pa equal to 0.0102 cmH2O.

v In this manual and in the ventilator, the respiration frequency unit shown is in respirations per minute (rpm) and not in Hertz (Hz) its
corresponding unit in the International System (IS). Being 1 Hz equal to 60 rpm.

v In this manual and in the ventilator, the volume unit shown is in milliliters (ml) or liters (l) and not in cubic meters (m ) its
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corresponding unit in the International System (IS). Being 1-6 m3 equal to 1 ml or 0.001 l.

v Upon reception please check the integrity of the equipment and its components. Should the equipment or its components show
any apparent damage, please contact an authorized K. TAKAOKA dealer immediately, because there are different warranty periods for the several components, refer to Chapter 19.

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v This product was manufactured following good manufacturing practices and procedures (BPF or GMP), using silicone rubber
that meets the regulations required for similar equipment / contact with food. During the operation the client shall take the necessary hygiene or sterilization precautions, in addition to tests to ensure that the product is adequate and safe for the desired specific application, because the utilization methods and conditions practiced by the users are beyond our control.

v The ventilator cannot be covered or kept in places with poor air circulation, in order to avoid overheating. v The ventilator has limited stability and can neither be transported nor used on surfaces with inclination equal to or above 5,
to avoid tipping.

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GENERAL DESCRIPTION

The Table below presents the ventilation modes available in the CARMEL Servoventilator. The modes requiring an inspiration effort from the patient to start the respiration cycles count with a protection system against apnea, with the automatic change to another reserve mode (backup). This feature results in increased safety for the patient.

Adjusted Mode

Description

Ventilation in Apnea ( Backup ) Not Applicable

1.

VCV/ ASSISTED

Volume-Controlled Ventilation

PCV/ ASSISTED 2. PLV/ ASSISTED PCV/AV

Pressure-Controlled Ventilation

Not Applicable

Pressure-Limited Ventilation

Not Applicable

3.

Ventilation Volume ensured by Pressure Control Mandatory Intermittent Ventilation synchronized with Volume Control Mandatory Intermittent Ventilation synchronized with Pressure Control Spontaneous Ventilation with Two Pressure Levels Ventilation with Continuous Positive Pressure in the Air Passages Ventilation with Pressure Support

Not Applicable

4.

SIMV/V SIMV/P BIPV

IMV (not synchronized)

5.

IMV (not synchronized)

6.

Not Applicable Not available if needed use PSV PCV

7.

CPAP

8.

PSV

The CARMEL Servoventilator has all its monitored controls and parameters displayed on a 15 color LCD monitor, with a resolution of 1024 x 768 that allows simultaneous visualization of all the ventilation curves in addition to the numeric values, and also features position, rotation and inclination adjustments. Types of curves: pressure x time, flow x time, volume x time; and types of loops: volume x pressure and flow x volume. Other characteristics of the CARMEL Servoventilator are described below.

v Direct digital controls for the main ventilation parameters, including current volume, respiration frequency, inspiration time,
inspiration pause, pressures, maximum inspiration flow, etc.

v Only the active controls are displayed in each ventilation mode, in the correct sequence for their adjustment. This resource
makes the ventilator adjustment much easier and safer.

v Digital control of the oxygen concentration in the AIR/O

concentration according to the gas networks.
2

mixture supplied to the patient, with automatic switching of the oxygen

v Pressure control directly in cmH O, making the ventilator adjustment easier. v Electronic manometer for the endotracheal pressure, with graphic display on a 15 color LCD monitor with resolution
of 1024 x 768. The value of the maximum pressure in the last inspiration is kept in the manometer display during the expiration phase, for a better visualization of this parameter.

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v Complete system of audiovisual alarms for ventilation parameters, with limits adjustable by the operator. These alarms are
capable of pointing out a series of irregularities during the ventilation, thus greatly increasing the therapy safety.

v Audiovisual alarms that show eventual failures in the ventilators gas feeding systems, including the oxygen and compressed
air networks, and that automatically switch to another O2 concentration to ensure the patients ventilation.

v Audiovisual alarms that point out eventual failures in the ventilators power source systems, including the electric network
and low internal battery.

v Pressure-assisted
ventilation cycles.

or flow -assisted cycle triggering. The flow trigger feature allows newborn patients to trigger the

v The STAND BY condition can be manually activated at any time, to prevent audio alarms during the preparation of the patient
or any other special event.

v Automatic selection of the adult, infantile or newborn patient modes, depending on the patients weight informed by the
operator when the ventilator is turned on (item 8.2).

v Nebulizer for medicines, where the nebulizer flow is automatically compensated during the determination of the current volume
and synchronized with the inspiration phase.

v TGI resource (Tracheal Gas Charger) available for adult patients in the controlled modes. v ILV resource (Independent Lung Ventilation), communication between 2 ventilators through an appropriate serial cable, which
is an optional component.

v Highly accurate inspiration and air/oxygen mixture flow control, with two electronically controlled servo-valves. v Rinsing flow system in the flow sensor tubes to eliminate the accumulation of secretions and humidity, which are the main
sources of errors during the monitoring of the ventilation parameters. The rinsing flow is automatically compensated during the determination of the current volume.

v Electronically controlled expiration valve that can be easily disassembled for internal cleaning and diaphragm inspection. v Special functions: inspiration pause during 5 seconds, supply of 100% of oxygen during 90 seconds, auto-PEEP measurement
(through expiration pause) and programmed relief.

v Electronic button for manual inspiration. v Electronic master on/off switch. v Highly sensibility flow sensor, for ventilation control and monitoring of parameters. v Automatic continuous flow for low current volume condition, for the ventilation of newborn patients. For adult/infantile patients,
the operator can adjust manually the rinsing flow of the respiration loop.

v Built-in pressure-regulation valves for oxygen and compressed air. Eliminating the use of valves external. v Anti-asphyxia safety valves.
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v Over pressure valve (high pressure) with automatic control. v Heated Humidifier with electronic temperature control and digital thermometer (optional). v Pivoted arm with support for corrugated tubes, which may be mounted on either of the ventilator sides, according to the side
where the patient was placed.

v Internal rechargeable battery in case of failure of the electric network or for transportation, when the ventilator will automatically
be powered through the battery.

v Power source network with 110 to 220 Vac, for the ventilator operation and recharge of the internal battery. v Visual indication of the power source, electric network or internal battery. v Silent operation. v Front handle for the adequate positioning of the CARMEL Servoventilator. v Movable base equipped with hooks to support extensions, pulling handle for transportation and caster wheels with brake.
2.1 Ventilation Monitor
The Ventilation Monitor incorporated to the CARMEL Servoventilator has multiple functions that monitor the mechanical ventilation. The 15 color LCD monitor, with resolution of 1024 x 768, displays the numeric values in real time for all the measured parameters, in addition to several options of endotracheal pressure, current volume, flow and other curves, which allow an accurate analysis of the ventilation. It also prepares a ventilation history using the last values of the parameters - recorded in the monitor memory and displayed as graphics or table. The knowledge of the parameters displayed by the monitor allows a more accurate follow -up of the patients ventilation. Some others important characteristics of the Ventilation Monitor are described below:

v Audiovisual alarms for the measured parameters, with minimum and maximum limits adjustable by the operator. v Measurement of inspiration flow, volumes and pressure through a flow sensor located in the respiration system.
The flow sensor features high precision and low response time.

v Measurement of FiO , Tobin index and P0.1.

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v Measurement of the current inspired and expired volumes and of the minute volume. v Real time graphics with automatic scale adjustment and image freezing control. v RESET key to silence the alarms for a maximum of 2 minutes. v Serial port connection for the ILV function through an adequate cable (this item is optional).

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TECHNICAL SPECIFICATIONS

Classification
NBR IEC-60601-1/97 (1994) & Correction no. 1 (1997) & Amendment no. 1 (1997) (Electromedical Equipment Part 1: General Safety Prescriptions) NBR IEC 60601-2-12/2004 (specific prescriptions for the safety of lung ventilation equipment in medical utilization Equipment Class 1 Internally Energized) NBR IEC 60601-1-2/1997 (Electromedical Equipment Part 1: General Safety Prescriptions 2. Collateral Standard: Electromagnetic Compatibility Prescriptions and tests) Equipment Class 1 Internally Energized Type B IPX0 Continuous Operation

Ventilation Modes
1 2. 2.1 3. 4. 5. 6. 7. 8. VCV .............................................................................................................................................. volume-controlled ventilation PCV ............................................................................................................................................pressure-controlled ventilation PLV.................................................................................................................................................. pressure-limited ventilation PCV/AV ...........................................................................................................ventilation volume ensured by pressure control SIMV/V ............................................................................ synchronized mandatory intermittent ventilation with volume control SIMV/P .........................................................................synchronized mandatory intermittent ventilation with pressure control BIPV .............................................................................................................spontaneous ventilation with two pressure levels CPAP.....................................................................................ventilation with continuous positive pressure in the air passages PSV ................................................................................................................................................pressure support ventilation

Ventilation Parameters
Parameter Frequency (rpm) Inspiration Time (s) Range 1 to 150 0.01 to 0.70 0.70 to 1.00 1.00 to 3.90 Oxygen Concentration (%) Maximum Limited Pressure (cmH2O) Maximum Work Pressure (cmH2O) PEEP/CPAP (cm H 2O) Support Pressure (cm H2O) Support Pressure Frequency (% of inspiration flow) Rise Time (s) Inspiration Pause (s) 21 to 100 5 to 100 5 to 100 0 to 50 0 to 80 5 to 80 0.10 to 0.40 0.01 to 0.70 0.70 to 1.00 1.00 to 8.10 Current Volume in adults (ml) 150 to 1000 1000 to 2500 20 to 150 150 to 250 4 to 120 OFF, 1 to 30 OFF,-1 to -20 OFF, 5 to 100 0.3 to 5.0 Patient Weight (kg) 5.0 to 20.0 20.0 to 200.0 0.01 to 0.70 Inspiration Time in the BIPV (s) 0.70 to 1.00 1.00 to 10.00 Manual Code: 204010259_002 Resolution 1 0.01 0.05 0.10 1 1 1 1 1 5 0.05 0.01 0.05 0.10 10 50 5 10 1 1 1 1 0.1 0.5 1.0 0.01 0.05 0.10 19

Current Volume in children (ml) Flow (l/min) Flow Sensibility (l/min) Pressure Sensibility (cm H2O) Relief (cycle)

Basic Flow (l/min) Sound Alarm(s) Silencer Rise Time in the PCV(s) NA = Not applicable

OFF, 4 to 40 120 OFF, 0 to 0.40

1 fixed 0.05

Note
Sub-atmospheric pressure is not available in the expiration phase.

Nebulizer
Capacity for medicines.....................................................................................................................................................................7 ml Nebulizer flow....................................................................between 5 and 10 l/min, synchronized with the beginning of the inspiration.

TGI
Charging flow ..............................................................................between 5 and 10 l/min, synchronized with the end of the expiration.

Special Characteristics

v Reserve modes (backup), in the case of apnea; v Complete alarm system; v Types of curve: square, decelerated, accelerated and sinusoidal; v Differential pressure type Flow Sensor; v Automatic compensation of the respiration loop complacency; v Electronic on/off switch; v Electronic and synchronized manual inspiration; v Pressure-regulation valves; v Anti-asphyxia safety valves with resistance between 0.3 and 0.5 (cm H O/lpm); v Overpressure electronic valve set on the adjusted pressure limit; v Rinsing flow in the flow sensor tubes between 2 and 10 (ml/min).
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Gas Feeding
Gases......................................................................................................................................................... oxygen and compressed air Feed pressure......................................................................................................................................50 to 150 PSI (280 to 1035 kPa) Pressure adjusted by the apparatus ............................................................................................................................ 35 PSI (241 kPa) Feed flow........................................................................................................................................................................... 50 to 70 l/min Threaded connections.............................................................................................................................per NBR12188/2003 standard Extension/Hose..................................................................................................................................................per ISO 5359 standard

Notes:
The CARMEL Servoventilator is equipped with internal pressure-regulation valves and can be connected directly to the outlet of the hospital gas networks installed according to the ISO 7396 standard in force. The use of external regulation valves is not recommended. The gas input connections are equipped with internal check valves that ensure the absence of the reverse flow of gas.

Caution
The use of a high pressure input in the patient brings risks to the same.

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Electric Characteristics
Source............................................................................ 110 to 220 Vac with automatic switching, 50/60 Hz, electric network according to the NBR-13534/95 standard, or 12 Vdc and 3.0 A external battery (to prevent the ventilator from feeding the Humidifier) Electric network connector ...............................................3 (three) pins, Nema 5-15P type, where the round central pin is the ground. Electric network input fuses................................................................................................ made of glass with 20mm - 3,0 A / 250 Vac Humidifier input fuses......................................................................................................... made of glass with 20mm - 2,0 A / 250 Vac Internal source input fuse................................................................................................... made of glass with 20mm - 4,0 A / 250 Vac Power consumed by the ventilator.............................................................................................................................50 VA (maximum) Power consumed by the Humidifier............................................................................................................................90 VA (maximum) Internal battery...............................................................sealed, of the lead/acid type, 12 Vdc, 9.0 Ah and a maximum current of 2.7 A required during charging. Internal battery service time ........................................... approximately 120 minutes, for an average ventilation condition in VCV, current volume=500 ml and respiration frequency =12 rpm Time to recharge the battery completely ....................................................................... approximately 20 hours, with the ventilator off. Graphic display .......................................................................................................high contrast liquid crystal, with cold cathode bulb.

Notes:
The internal rechargeable batteries can only be replaced by the K.TAKAOKA authorized Technical Assistance. The hospitals electric installation shall be duly grounded and meet the ABNT NBR 13534 standard - Electric installations in health care institutions - Safety requirements. The non-compliance with this recommendation may cause damages to the patient, operator or equipment, in addition to voiding the ventilators warranty.

Others
Conical connections.......................................................................................................................according to the ISO 5356 standard Corrugated tubes............................................................................................................................according to the ISO 5367 standard

Dimensions and weight including the movable base and components:

Height.......................................................................................................................................................................................1330 mm Width..........................................................................................................................................................................................400 mm Depth..........................................................................................................................................................................................500 mm Weight.......................................................................................................................................................................................... 27 kgf

Packaging
Individual, developed to suit transportation and storage at a temperature of 10C to +70C, a atmospheric pressure of 500 to 1060 hPa and a relative humidity of 10% to 100% (not condensed).

Ambient Use Conditions

Temperature of 10C to +70C, atmospheric pressure of 500 to 1060 hPa and a relative humidity of 10% to 100% (not condensed).

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3.1

Ventilation Monitor Specifications

Parameters Measured in ATPD (ambient temperature and pressure, dry)

Parameter Current average expired volume (ml) Current average inspired volume (ml) Minute volume (l) Respiration frequency (rpm) Maximum inspiration pressure (cm H2O) Range 100 to 2600 20 to 100 100 to 2600 0.1 to 50 1 to 200 -30 to 120 Resolution 5 5 0.01 1 1 Accuracy (15% or 20 ml) (50% or 10 ml) (15% or 20 ml) (15% or 0.5 l/min) (1 s -1 or 10%) (2 cm H2O + 4% of the measured value) (2 cm H2O + 4% of the measured value) (2 cm H2O + 4% of the measured value) (2 cm H2O + 4% of the measured value) 10% 10% 10% 0.2 s 30% 5% (2 cm H2O + 4% of the measured value) (2 cm H2O + 4% of the measured value) 10% 5%

Plateau inspiration pressure (cm H2O)

-30 to 120

Pressure at the end of expiration (PEEP) (cm H2O)

-30 to 120

Average inspiration pressure (cm H2O) Static lung complacency (Cstat) (ml/cm H2O) Dynamic lung complacency (Cdyn) (ml/cm H2O) Resistance of the aerial passages (Raw) (cm H2O/l/min) Inspiration time (s) I:E Ratio FiO2 (%) Intrinsic pressure at the end of expiration (ipeep) (cm H2O) Occlusion pressure (P0.1) (cm H2O) Inspiration work (WOB) (J/l) Tobin index (iT)

-30 to 120 1.00 to 100.00 1.00 to 100.00 1.0 to 100.0 0.01 to 20 6:1a 1:10 14 to 100 -30 to 120

1 0.01 0.01 0.1 0.01 0.1 1 1

-30 to 120 -10.00 to 50.00 0 to 200

1 0.01 1

Notes:
The CARMEL Servoventilator monitors only current exhaled volumes above of 100ml, due to the sensibility of the flow sensor used. The FiO2 monitor is in compliance with the ISO 7767 standard.

Graphics Options
Graphic Unit

Flow x time ......................................................................................................... l/min x s Pressure x time .................................................................................................. cmH2O x s Volume x time .................................................................................................... ml x s Flow x volume .................................................................................................... l/min x ml Volume x pressure............................................................................................. ml x cmH2O

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Alarms and Numeric Adjustments

Parameter Apnea Time alarm (s) Audio volume alarm Clock (hours) Clock (minutes) Cell calibration with 21% of O2 Cell calibration with 100% of O2 Range 5 a 60 2 a 10 0 a 23 0 a 59 NCAL (dont calibrate) CAL (calibrate) NCAL (dont calibrate) CAL (calibrate) Low pressure alarm (cmH2O) High pressure alarm (cmH2O) Low PEEP alarm (cmH2O) High PEEP alarm (cmH2O) High Minute Volume alarm (l) Low Minute Volume alarm (l) Low Frequency alarm (rpm) High Frequency alarm (rpm) Low FiO2 alarm (%) High FiO2 alarm (%) OFF, 1 to 120 OFF, 1 to 120 OFF, 1 to 70 OFF, 1 to 70 OFF, 0,1 to 99,0 OFF, 0,1 to 99,0 OFF, 1 to 160 OFF, 1 to 160 OFF, 0 to 100 OFF, 0 to 100 1 1 1 1 0,1 0,1 1 1 1 1 Na Resolution 1 1 1 1 Na

Notes:
The ventilators alarm system meets the ISO 9703-1, ISO 9703-2 and ISO 9703-3 standards.

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OPERATION PRINCIPLE

Oxygen (O2) and compressed air enter the CARMEL Servoventilator through their respective threaded connections. The pressures are then reduced by a set of regulation valves. Each gas then follows to its respective flow control servo-valve, which is driven by an electronic control in order to supply the exact quantity of each gas in every moment, which are then mixed and forwarded to the respiration loop during the inspiration phase. During the inspiration phase, the flow value supplied will depend on the selected ventilation mode and on the parameters adjusted in the equipment. An electromagnetic valve acting in the respiration loop, which is controlled by a microprocessed electronic system, carries out the inspiration pressure control.

Resupply

Figure 4.1: Operation principle of the ventilator

4.1

Flow Servo-Valves

The Flow Servo-Valve converts the current signal into flow, when there is a pressurized gas in its inlet. Figure 4.2 shows that when the current applied to the valve in zero is maintained, the flow in the outlet is zero, because its natural status is NORMALLY CLOSED (NF). What keeps the valve closed is a calibrated spring that exerts enough force for the needle to maintain the gas passage closed. When a current is applied to the needle, it compresses the spring, allowing the passage of the gas from the inlet to the outlet. This Flow Servo-Valve of is also called "Proportional Valve", because the flow of gas is directly proportional to the current applied.

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I=0

I>0

Figure 4.2: Flow Servo-Valves. (I = current)

4.2

Electronic Mixer

The mixture of gases is electronically controlled by means of the two servo-valves to which currents proportional to the total flow desired are applied.

I Total Flow= IO2 + Iair

Flow ( lpm )

Total Flow = F_Air + F_O 2

Blender % O 2

I_O2

I_Air
Figure 4.3: Electronic blender.

Current (mA)

4.3

Electromagnetic Valve

Figure 4.4 shows schematically the electromagnetic valve construction, which counts with a simple and safe operating principle. The diaphragm controls the flow passage and isolates the inside part of the valve to avoid contamination. The diaphragm drive is carried out through a pin that moves together with the movable coil that, by its turn, moves along the inside of a magnet. The diaphragm closing force depends on the electric current applied to the coil, which is electronically controlled with the help of a resupply system.

Figure 4.4: Electromagnetic valve.

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4.4

Flow and Volume Measurement

The CARMEL Servoventilator counts with two flow sensors for the measurement of the gas flows and volumes, being one internal and the other external, coupled to the respiration system. Each flow sensor of the differential pressure type is composed by an adapter w ith two conical connections, having inside a resistance to the passage of the flow (Figure 4.5). Two side tubes conduct the pressure signals in the inlet and in the outlet of the flow sensor up to a differential pressure transducer located inside the Servoventilator housing. The value of the inspired or expired flow is measured at every instant, depending on the pressure difference through the sensor. The flow sensor also makes the detection of the Servoventilators cycling instants. When the flow value is known at every instant, the current inspired and expired volumes can be calculated by a flow integration along time, being such integration carried out by a microprocessor.

Figure 4.5: Flow Sensor. (?P = pressure variation)

4.5

Oxygen Measurement

The Oxygen Analyzer incorporated to the CARMEL Servoventilator (Figure 4.6) measures the Oxygen percentage in the gaseous mixture in contact with its sensor. The O2 sensor includes a galvanic cell with an electrode system that, by means of electrochemical reactions, supplies, to the CARMEL Servoventilator electronic circuit, an electric voltage signal proportional to the Oxygen concentration in the mixture. This signal is analyzed by the microprocessor and later converted into a digital value representing the Oxygen volumetric percentage.

1 O2 Sensor 2 Cable 3 Connector

Figure 4.6: Oxygen analyzer. Please find below the definitions of some of the parameters measured by the Ventilation Monitor:

v Resistance of the aerial passages (Jonson Method): pressure at the end of the inspiration - PEEP/ maximum expired flow. v Static lung complacency: current inspired volume / (plateau pressure - PEEP) v Dynamic lung complacency: current inspired volume / (peak pressure - PEEP) v Inspiration work: integral of the pressure along the inspiration, in volume. v P0.1 (occlusion pressure of the aerial passages): inspiration pressure after 100 milliseconds after the occlusion v Tobin index: spontaneous respirations/minute/liters
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CONTROLS AND COMPONENTS

The following components are supplied together with the CARMEL Servoventilator, and shall be exclusively used with the same:

5.1

Components List

The following items compose the CARMEL: CODE 201050003 202011639 202010614 202011152 202011182 202011665 202011669 202012068 203060031 203100149 202012085 204010258 Heated Humidifier 6060 Pivoted arm Compressed air filter for ICU ventilator Expiration valve diaphragm 3 m extension for O2 (2 9/16 x 18F female threads) 400 mm flow sensor tube made of silicone w/ terminal Adult silicone respiration loop ICU Mont. Carmel 3 m extension for air (2 female dis. threads) Luer lock lid Adult Flow Sensor (engraved) O2 measurement cell with intermediate piece and cable. Operation Manual Description Quant. 1 1 1 1 1 1 1 1 1 1 1 1

Code: 201050003

Code: 202011639

Code: 202010614

Code: 202011152

Code: 202011182

Code: 202011665

Code: 202011669

Code: 202012068

Code: 203060031

Code: 203100149

Code: 202012085

Code: 204010258

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5.2

Optional Items
CODE Description Infantile silicone respiration loop Newborn silicone respiration loop Line filter for O2 Infantile Flow Sensor ILV Cable Quant. 1 1 1 1 1

202011670 202011671 202011938 203100150 429090245

Code: 202011670

Code: 202011671

Code: 202011938

Code: 203100150

Code: 429090245

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5.3

Front View

The items below refer to the front side of the CARMEL Servoventilator.

LCD Color Monitor

Control Panel

Easy Touch Button

Figure 5.1 Front view CARMEL Servoventilator

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5.3.1

LCD Monitor

15 color LCD Monitor (crystal liquid display) that allows simultaneous visualization, with a resolution of 1024 x 768, of all the ventilation curves, pressure x time, flow x time and volume x time, loops of: volume x pressure and flow x volume, in addition to the numeric values, functions, alarms and the visualization of the navigation. The monitor allows position and inclination adjustment in addition to the and image configuration adjustments.

5.3.2

Control Panel

The control panel contains the keys for access to the special functions and the quick access keys.

Notes:
The keys in the panel only highlight the parameter values in the ventilator, so they may be adjusted and confirmed through the increment, decrement and confirmation EASY TOUCH button. Thus characterizing a safety system that prevents undesired adjustments.

5.4

EASY TOUCH Button

Programming Button (Easy Touch)

On the side of the CARMEL Servoventilator control panel, this button allows the simple and quick adjustment of the ventilation parameters. This button shall be operated in the sequence described below, f or the adjustment of each one of the ventilation parameters shown highlighted in the display:
ENTER

Turn the button clockwise or counter-clockwise, until the cursor (green circle) is placed over the parameter to be adjusted. Press this button again. The parameter is highlighted in the display (blue background). Turn the button to adjust the numeric value desired for the parameter. Turning it clockwise the value increases and turning it counter-clockwise the value decreases. Press the button again to confirm the adjustment made, thus making effective the new parameter value. The parameter is removed from highlight in the display.

5.5

Front Connection Panel

Figure 5.2. Front Connection Panel CARMEL Servoventilator.

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The items below refer to the Front Connection Panel of the CARMEL Servoventilator (Figure 6.2). 1 - Connector for the Flow Sensor tube (Blue) Entrance for the flow sensor tube with blue stripe. The other end of this tube shall be connected to the largest diameter nozzle connected to the flow s ensor. Use only the sensor supplied by K. TAKAOKA.

Warning
The two tubes must be mounted in the correct position, according to the color coding found in the ventilator connectors. The tubes have different colors for quick identification. Get more information in item 6.4.

2 - Connector for the Nebulizer tube or TGI Catheter Entrance for the medicine Nebulizer tube, which is an optional component of the CARMEL Servoventilator. The other end of this tube must be connected to Nebulizer glass. Entrance for the TGI catheter. The catheter necessary for the procedure is not included in the equipment. 3 - Expiration Valve Block The block containing the expiration valve and two conical connectors for the respiration loop corrugated tubes. The expiration valve perf orms the control of the inspiration and expiration phases. This set can be disassembled for the cleaning and sterilization of its diaphragm, and its assembly must be carried out correctly according to the instructions of item 6.5. 4 - Connector for the Flow Sensor tube (colorless) Entrance to the colorless flow sensor tube. The other end of this tube must be coupled to the nozzle with lower diameter connected to the flow sensor. Use only the sensor supplied by K. TAKAOKA. 5 - Connector for the FiO2 sensor A sensor used to conduct the FiO2 measurement through an oxygen analyzer.

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5.6

Rear View

19

18

17

16

15 14 1 2 13 12 11 3 4 10 9

7
Figure 5.3 Rear Connection Panel CARMEL Servoventilator 1 On/Off Master Switch The electro-pneumatic master switch interrupts the gas flow in the OFF position and automatically disconnects the electric portion of the CARMEL Servoventilator and of the Heated Humidifier. When in the ON position, the ventilator and the Heated Humidifier are connected. Check the symbol table. 2 Power cable entrance with entrance fuse A compartment housing a fuse that protects the electric portion of the ventilator. Entrance for the connection of the ventilator to an electric network, by means of the detachable power cable supplied together with the ventilator. This cable has a 3 -pin connector for connection to a duly grounded electric network. Refer to the technical specifications for more information.

Notes:
The ventilator can be equally powered with voltages between 110 and 220 Vac, because it has an automatic voltage converter. The recommendations about power source described in item 6.2. must be followed.

3 Clip A nylon clip used to fasten the power source cable to prevent accidental disconnection. 4 Pressure Regulation Valve A valve that reduces the pressure that feeds the ventilator. Not adjustable.

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5 Entrance Connection - Compressed Air A threaded connection to the compressed air filter supplied with the ventilator. The filter inlet must be connected to the source of the respective gas through a compressed air extension included in the equipment. The compressed air source pressure and flow shall meet the technical specification. 6 Pressure Regulation Valve A valve that reduces the pressure that feeds the ventilator to 35 PSI - 248 KPa. 7 Outlet for Measurement of the Regulated Pressure A connection to the pressure regulation manometer, for the measurement of the value of the pressure regulated by valve (6). The measured pressure must be 35 PSI (241 kPa). This outlet is used to make the equipments maintenance procedure easier, which can only be carried out by an authorized K. TAKAOKA technician. 8 Oxygen Entrance Connection A threaded connection for the oxygen extension supplied with the ventilator, for connection to the source of the respective gas. The oxygen source pressure and flow shall meet the technical specification. 9 Pressure Regulation Valve A valve that reduces the pressure that feeds the ventilator. Not adjustable. 10 Electric Outlet for the Heated Humidifier An electric outlet that powers the Heated Humidifier 6060 with the same voltage and frequency connected to the entrance cable (the Heated Humidifier has automatic voltage conversion). This outlet only supplies electric power. Refer to the technical specification for more information. 11 110V Electric Outlet for the 15 LCD Monitor An electric outlet that powers the CARMEL 15 monitor. The Heated Humidifier does not work with this type of connection and source. 12 Outlet for the Network Communication Interface An Ethernet port. To be connected to an equipment with NBR IEC 60601-1 certification. (Item for future implementation). 13 Symbol for Read the Attached Documents 14 Serial Port 3 for the Communication Interface with External Devices Serial port, with communication interface to external devices, according to the NBR IEC 60601-1.

Note:
The serial cable and the external devices are not included in the CARMEL Servoventilator, they constitute optional components. To obtain more information about the necessary software and hardware requirements, contact an authorized K. TAKAOKA distributor.

15 Video Entrance connector for the LCD Monitor video cable. 16 / 17 Outlet for the Communication Interface with External Devices Serial ports used during the updating/maintenance carried out by the duly trained technicians. 18 / 19 2 (two) Outlet Fuses for the Humidifier Compartment with fuses for the protection of the electric portion of the Humidifier 6060, one fuse is positioned in the phase and the other in the neutral. Refer to the technical specification for more information.

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5.7 Note:

Heated Humidifier
Read carefully the Instruction Manual of the Heated Humidifier 6060.

The Heated Humidifier 6060 (Figure 5.4) was specifically designed for use in the respiration loops. It counts with electronic temperature control, digital thermometer, pilot lights and electric resistance operation lights, on/off switch and transparent chamber with capacity for 400 ml of sterile water. The temperature of the gases is measured close to the patients mouth, through an electronic temperature sensor. The CARMEL Servoventilator on/off master switch also turns on and off the Heated Humidifier power source. The Heated Humidifier heats and saturates with water vapor the inspiration flow that crosses its chamber. The gases follow a path between the chamber outlet and the patient, through two corrugated tubes with drains. It is common for water to condense inside the corrugated tube that reaches the patient, due to the cooling of the gases between the humidifier outlet and the intermediate Y piece. The quantity of water condensed in the loop increases together with an increase in the humidifiers heat.

SAFETY MEASURES FOR THE USE OF THE HEATED HUMIDIFIER 6060:

1. It is necessary to prevent the water condensed in the loop from flowing to the patient, because it could reach the lungs. In

order to force all the water condensed in the loop to flow back to the drains, the corrugated tubes shall present an upwards or horizontal direction towards the patient (Figure 5.5). 2. If the condensation of water in the loop is excessive, the humidifier shall have its temperature decreased.

The Heated Humidifier chamber can be easily disassembled for disinfection , because its cover is only screwed to the glass. When assembling the chamber again, make sure that the rubber seal in the cover is correctly positioned and in perfect conservation condition, to avoid the leakage of gases during ventilation. Close the cover tightening it firmly.

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Chamber Outlet Connection (Patient) Humidification Chamber Cover (autoclavvel) Humidification Chamber (autoclavvel) Chamber Fastening Clamps Chamber Fastening Button Temperature display Heating control Pilot lamp (Heater On) Heating lamp (Power On) Entrance for replenishing

Figure 5.4. Heated Humidifier 6060.

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RIGHT

EXP.

WRONG

INSP.

PATIENT WATER FOR PATIENTS

WATER DRAINAGE

HUMIDIFIER HEATED

Figure 5.5. Positioning of the corrugated tubes.

5.8

Expiration valve

An electromagnetic valve that defines the inspiration and expiration phases of the CARMEL Servoventilator composes the expiration valve. During the expiration phase, the valve is opened to allow the exit of the expired gases. The expiration valve block is fastened to the Front Connection Panel of the Servoventilator (item 5.3). This allows the respiration loop tubes to be directed to either of the two Servoventilator sides, depending on the side where the patient is placed. Figure 5.6 shows a scheme of the assembly of the expiration valve block components. This block has in its body two conical connections to the respiration loop corrugated tubes. The expiration valve is easily disassembled for the disinfection of the components, inspection or the replacement of the diaphragm . After each assembly of the expiration valve with its diaphragm correctly positioned, the Servoventilator shall be turned on and a test procedure conducted to ensure its perfect operation.

Warning
Check regularly the cleanliness and the perfect conservation of the expiration valve diaphragm. In case any fissure or other irregularity is found in this component, it shall be replaced for a new one. Check regularly the perfect conservation of the sealing ring (O-ring). The fastening of the block to the Front Connection Panel of the Servoventilator shall be very tight to avoid gas leaks.

Figure 5.6. Mounting of the expiration valve.

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5.9

Drains

The CARMEL Servoventilator respiration loop counts with 2 (two) drains that collect the water condensed inside the corrugated tubes, being one drain located in the inspiration branch and the other in the expiration branch. Its is very important to use the drains in order to avoid the inconveniences caused by the water build-up in the respiration loop. Draining Draining is carried out by removing the drain threaded glass and emptying the accumulated water, and then screwing the glass back to the drain body. This operation does not disturb the patients ventilation, because the drain counts with an automatic closing system when the glass is removed. Disinfection The drain is easily disassembled for disinfection, by removing the threaded glass and then the plunger set (Figure 5.7).

BODY

PLUNGER

GLASS

Figure 5.7. Respiration loop drain.

5.10

Nebulizer (optional)

The Nebulizer (Figure 5.8) is an optional component of the CARMEL Servoventilator and is used to administer medicines to the patient through a flow of gas that enters the respiration loop during the inspiration phase. O Nebulizer reservoir has capacity for 7 ml of medicine.

Figure 5.8. Nebulizer for medicines. The monitor located in the Servoventilator control region allows the operator to turn on and off the nebulizing function (Chapter 8). The Nebulizer can be mounted close to the endotracheal mask or tube or in the inspiration branch. The tube that feeds the Nebulizer shall be connected to the respective NEBULIZER connection nozzle located in the Front Connection Panel of the ventilator.

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Notes:
The Nebulizer is destined for use in adult, infantile and newborn patients, however, in some modes. The nebulization flow is automatically compensated in the determination of the current volume, therefore, the expired volume is slightly higher than the inspired volume. During the operation of the Nebulizer the FiO 2 may be affected. When filling the Nebulizer glass, do not exceed the maximum medicine capacity in the reservoir.

Warning
The use of humidifying filters and/or heaters after the Nebulizer is not recommended when this resource is in use, because these filters may introduce a significant increase in the respiration resistance. Never leave the supply tube connected to the Front Panel when the Nebulizer resource is not in use, even when the reservoir is empty.

5.11

TGI - Tracheal Gas Insufflation

The TGI (Tracheal Gas Insufflation) is a resource available in the CARMEL Servoventilator, intended to increase the elimination of CO2 together with the washing of the anatomic dead space. The TGI is carried by out a flow of fresh gas injected in synchronization with the end of the expiration, reaching inside the trachea (through a special catheter located inside the endotracheal tube), this flow has the function of pushing out the anatomic dead space volume, which is rich in CO2, thus ensuring that, at each inspiration cycle, the volume supplied to the patient is composed exclusively by fresh gases free of CO2. The configuration screen of the Servoventilator control display allows the operator to turn on and off the TGI function (Chapter 8). The TGI catheter must be mounted inside the endotracheal tube and connected to the NEBULIZER/TGI nozzle located in the Front Connection Panel of the Servoventilator (item 5.3).

Notes:
The TGI is destined for use only in adult patients (weight higher or equal to 26 kg) and is available only in the controlled modes (VCV, PCV and PCV/AV). The TGI flow is automatically compensated in the determination of the current volume, therefore, the expired volume is slightly higher than the inspired volume. During the utilization of the TGI the FiO 2 may be affected. When an auto-PEEP occurs (figure below), the absence of zero flow, indicating the end of the expiration, does not imply that the TGI is not in use.

Flow Temp

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5.12

Battery

The CARMEL Servoventilator is equipped with an internal battery that allows its operation in case of failure of the electric network. The CARMEL Servoventilator internal battery is rechargeable, sealed, of the lead/acid type, 12 Vdc and 9.0 Ah, and there is no need to remove it even when the equipment remains out of use for long periods.

Duration
The duration time of the ventilators internal battery charge depends on the mode of use and on the adjustment of the ventilation parameters. Example: When fully charged, the battery is able to keep the ventilator operating for approximately 120 minutes in an average ventilation condition.

Recharging
The full recharging of the battery takes approximately 20 hours with the Servoventilator off and connected to the electric network. To ensure longer battery service life, keep the battery always when possible with maximum charge. Constant battery discharging reduces its service life .

Alarm
When the electric network is down, the Servoventilator is automatically switched to the internal battery. When the ventilator is being powered by the internal battery, the display will show the message ELECTRIC NETWORK DOWN BATTERY IN USE, the electric network led will turn off and the network cable symbol in the lower left corner will be replaced by the battery symbol, which confirms that the ventilator is now being powered by the internal battery. In order to indicate the battery capacity, the battery symbol has three statuses that are shown in the figure below.

Battery 1 - Battery above 40%

Battery 2 - Battery between 40% and 20%

Battery 3 - Battery below 20%

When the battery is above 40% of its capacity, the Battery 1 figure will be displayed; when it is between 40% and 20% of its capacity, the Battery 2 figure will be displayed and when the battery is below 20% of its capacity, the Battery 3 figure will be displayed. When the battery is below 40% of its capacity a medium priority alarm will sound and when the capacity falls below 20 % a high priority alarm will be displayed, indicating that the electric power must be immediately reestablished.

Warning
Keep the internal battery always charged. Therefore, the Servoventilator can be left permanently connected to the electric network, even with the on/off switch in the off position. The battery must be recharged after any utilization time of the Servoventilator with the electric network down. The battery must be fully recharged if the Servoventilator was not in use and disconnected from the electric network for a period longer than 20 (twenty) days. The Heated Humidifier does not work while the i nternal battery is powering the Servoventilator.

5.13

Movable Base

The CARMEL Servoventilator movable base is equipped with four caster wheels with front brakes that ensure excellent mobility, hooks that support extensions and a handle that makes the transportation easy. The Servoventilator is fastened to the upper part of the movable base by means of a set of four screws. The Heated Humidifier is fastened to the front part of the movable base, through fitting pins.

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ASSEMBLY AND PREPARATION OF THE CARMEL

Warning
The assembly instructions provided in the explanatory sheets, supplied together with the equipment, shall be carefully followed. The details in the following items of this Chapter also provide guidance.

6.1

Assembly of the CARMEL

The CARMEL is not supplied fully assembled, the LCD Monitor, the basic unit, the column (movable base) and the pivoted arm must be assembled as shown in figure 6. v v v Four screws fasten the monitor to its base, Four screws fasten the basic unit to the movable column, The pivoted arm is only fitted to the respective support.

A more detailed assembly guide is supplied together with the equipment, where the user finds orientation regarding the reception and assembly of the equipment.

Fig. 6 Assembly of the monitor and the pivoted arm

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6.2

Power Source

1. Check initially whether the on/off master switch located in the CARMEL rear panel is in the off position. 2. The O2 and compressed air entrance connections located in the CARMEL rear panel must be connected to the respective sources of these gases. Use the extensions supplied together with the Servoventilator. The use of the network pressure regulation valve on the wall is not necessary when the pressures are kept within the specified range.

Warning
The oxygen and compressed air feed pressures must be held in the range between 40 and 150 PSI (280 and 1035 kPa). Connect the air filter supplied together with the equipment between the Servoventilator compressed air connection and the respective extension. The source compressed air must be free of humidity, oil and impurities.

3. Connect the CARMEL to an 110 to 220 Vac electric network using the power cable supplied together with the equipment or a 12 Vdc 9.0 Ah source (internal battery). 4. Mount the Heated Humidifier 6060 on the column and connect it to an electric outlet located in the CARMEL Servoventilator rear panel. The Heated Humidifier only works if a 110 to 220 Vac electric network powers the Servoventilator. 5. The ventilator has an internal rechargeable battery that allows the temporary use of the equipment when not connected to the electric network. In the case of an electric network failure, the ventilator switches automatically to the internal battery and, therefore, ventilation continues without interruption. The power source indicator (1) blinks while the internal battery is powering the ventilator.

Note:
The switching between the external source (electric network) and the internal source (battery) does not interfere in the ventilator operation.

RECOMMENDATIONS ABOUT THE POWER SOURCE (*):

v Connect the power cable only to an outlet duly grounded and approved for hospital use, belonging to an electric network that
meets the ABNT NBR 13534 standard - Electric installations in health care institutions - Safety requirements . The female three-pin outlet shall be of the Nema 5-15P type, where the central round pin is the ground, as shown in the Figure below.

v Keep the internal battery always charged, so the Servoventilator will continue to operate even if the electric network eventually
fails. Therefore, the Servoventilator shall be left always connected to the electric network , even when not in use.

v Recharge the battery after using the Servoventilator while not connected to the electric network, thus preparing the battery for
the next utilization period.

v Perform a complete battery recharge when the Servoventilator was not in use and disconnected from the electric network for a
period longer than 20 (twenty) days.

v The Servoventilator internal battery does not power the Heated Humidifier. v If the internal battery is powering the Servoventilator and the battery low alarm is activated, the Servoventilator must then be
immediately connected to the electric network.

v The connection of the equipment to the auxiliary network outlet may increase the current drain through the patient up to values
that exceed the allowable limits in the case of a defective protection ground conductor.

v When installing the Servoventilator, fasten the power source cable 429020003, with the clamp ring 203060266 and using the
screw 314020013, to the rear panel.

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(*) The non-compliance with these electric recommendations, may result in damages to the patient, operator or equipment, in addition to voiding the Servoventilator warranty.

CONNECTION

1 3

PIN 220V 1
2 3

110V
NEUTRAL PHASE GROUND PHASE PHASE GROUND

Figure 6.1. Three-pin electric outlet, of the Nema 5-15P type.

6.3

Respiration loop

The CARMEL Servoventilator is available with three types of respiration loops: adult, pediatric and newborn. The newborn loop is equipped with smaller diameters tubes when compared with the adult ones, thus reducing its complacency when used with low flows. The CARMEL Servoventilator respiration loops are composed by a set of corrugated tubes, two drains, one intermediate Y piece and one flow sensor with tubes and lines. The drains mounted in the inspiration and expiration branches prevent water build-up in the loop. A checklist of items that must be periodically checked is given below: 1. Check whether the drain glasses are empty. If not, they must be emptied (item 5.9). 2. Be sure of the correct and tight coupling of the expiration valve block to the Front Connection Panel of the Servoventilator (item 5.5). 3. Check whether all the respiration loop components were submitted to the adequate disinfection procedures, including the corrugated tubes, intermediate pieces, drains, humidifier chamber and flow sensor. 4. Read carefully the Heated Humidifier 6060 instruction manual to ensure a correct assembly and utilization. 5. Fasten the pivoted arm to one of the respective side supports of the Servoventilator, to properly accommodate the corrugated tubes. The pivoted arm can be mounted to either side of the equipment, depending on which side the patient is placed. 6. Mount the CARMEL Servoventilator respiration loop according to the diagrams of Figures 6.2, 6.3 and 6.4. 7. When desired, assemble correctly the medicine Nebulizer, which is an optional component (item 5.10). The spiral tube that feeds the Nebulizer must coupled to the respective connection nozzle located in the Servoventilator Front Connection Panel (item 5.5). 8. If the TGI resource is used (item 5.11), its catheter (optional) shall be coupled to the connection nozzle located in the Servoventilator Front Connection Panel. (item 5.5). 9. Be sure of the correct and tight coupling of the electronic temperature sensor of the Humidifier 6060 to its respective connection in the intermediate Y piece of the respiration loop. 10. The emptying of the drain glass is easily accomplished without interruption of the ventilation, because the drain is equipped with an automatic closing system when the glass is removed. Empty the drains before they are filled with water (item 5.9).

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Warning
In order to avoid accidental disconnection or gas leaks in the respiration loop, be sure all connections are properly tightened. Tighten firmly the threaded cover of the Heated Humidifier 6060, and be sure the rubber seal is in place. In order to force the water condensed in the loop to return to the drains and not rea ching the patient, the corrugated tube support shall be positioned close to the intermediate Y piece, in a position lower than the patients mouth. Dont use anti-static or electrically conductive tubes or hoses.

Figure 6.2. Adult respiration loop.

Figure 6.3. Infantile respiration loop

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Figure 6.4. Newborn respiration loop

6.4

Flow Sensor

The CARMEL Servoventilator performs the measurement of flow, volumes and pressures by means of a flow sensor of the differential pressure type. The flow sensor must be mounted according to the procedure described below. 1. Connect the type of flow sensor required by the screen during the Servoventilator initialization, which will be the type that best suits the weight of the patient informed by the operator. The two flow sensor options available are adult and infantile.

Notes:
The infantile flow sensor is adequate for both newborn and pediatric patients.

2. Connect the flow sensor appropriate for newborn patients (= 6 kg) between the intermediate Y piece of the respiration system and the mask or endotracheal tube. For adult and pediatric patients (> 6 kg) the flow sensor must be connected to the expiration branch of the valve block (distal from the patient).

2 3
1. 2. 3. Flow Sensor Flow Sensor tube with blue list Colorless Flow Sensor tube

1
Figure 6.5. Flow sensor assembly. 3. Interconnect the two flow sensor tubes to the respective connectors located in the Servoventilator Front Connection Panel, observing their correct position and also check the correct c onnection of the tubes to the flow sensor (Figures 6.5 and 6.6).

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Notes:
The connectors located in the Servoventilator Front Panel are equipped with the wash flow system for the flow sensor tubes, in order to remove secretions and humidity, which are the main source of errors during the monitoring of the ventilation parameters. The wash flow is automatically compensated in the determination of the current volume.

tubes to the CARMEL Servoventilator. Figure 6.6. Connection of the flow sensor
Warning
Observe the flow sensor and the tube color coding, to be sure they are mounted in the correct position. The 15-mm female connection (larger) corresponds to the patient side, and the 15-mm male connection (smaller) corresponds to the respiration system side of the ventilation equipment. The two tubes have different colors to allow quick identification. During the utilization of the Servoventilator, check the flow sensor frequently for cleanliness.

6.5

Cell/O2 Sensor

The CARMEL Servoventilator performs FiO2 measurement through an Oxygen Analyzer with the help of an O2 Sensor. The procedure below must be followed to perform this assembly: a) Remove the sensor from its packaging.

Notes:
When the O 2 Sensor is not in use, it shall be stored in a hermetically closed packaging to avoid contact with the ambient air, this contact will cause the reduction of its service life. Temperatures above 25C also reduce the sensors service life.

b) c)

The packaging shall be kept for future storage. Interconnect the O2 Sensor cable connector (Figure 6.7) to its respective housing located in the CARMEL Servoventilator Front Connection Panel (figure 6.6). Then connect the O2 Sensor (duly cleaned or sterilized) to the other end of this cable.

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1 O2 Sensor 2 Cable 3 Connector

Figure 6.7. Oxygen Analyzer.

6.5.1

Calibration before using the O2 Sensor

The calibration of the O2 cell shall be adjusted to the concentration of 21% of O2 (ambient air). When in use for long periods (2160 hours) also perform the calibration for 100% of O2.

Notes:
The requirement to calibrate for 21% or 100% of O 2 does not imply in the automatic change of the oxygen concentration in the ventilator. Perform the oxygen concentration adjustment in the ventilator before the calibrations and be sure of the return to the desired value.

a)

Press the MONITOR (12) key successively until it reaches the screen where the activation options Cell O2 Cal 21% or 100% shows up in the monitor.

b) c) d) e)

Rotate the EASY TOUCH button until the item Cell O2 Cal 21% or 100% is highlighted and then press it to select the option. Rotate the EASY TOUCH button to change the NCAL status (dont calibrate) to CAL (calibrate). Calibrate the oxygen cell for one concentration at a time. After the calibration, the FiO2 xx% Calibrated message will be displayed in the lower part of the panel. When the calibration is not performed the FAILURE Calibrating FiO2 xx% message will be displayed in the lower part of the panel.

Warning
When the calibration is not achieved check: The oxygen cell conditions. The cells have a durability of approximately 8640 hours after removed from the packaging; The cable conditions; The correct connection of the cable to the oxygen cell and to the ventilator panel.

6.5.2
a)

After calibrating the O2 sensor

Position the O2 sensor in contact (in the horizontal position) with the gaseous mixture to be monitored. For this purpose, use the intermediate T piece that is connected between the expiration valve block and the corrugated tube of the inspiration branch (Figure 6.8).

b) c)

Check whether the sensor connection is perfectly sealed, to avoid gas leaks. The Servoventilator monitoring screen now displays the FiO2 concentration in the gaseous mixture.

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Warning
If there is any doubt about the correct calibration of the O2 sensor during the equipment operation, repeat the calibration procedure.

Expiration Valve Block O2 Sensor Cable

Intermediate T piece

O2 Sensor

Inspiration Branch

Figure 6.8. Correct positioning of the O2 Sensor in the respiration loop.

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7
7.1

CONTROL PANELS
Control panel 1 2 3 4 5 6 7 8 9

15

14

13

12

11

10

Figure 7.1. Front view Ventilator control panel. 1 - Electric Network Indicator - Network (green) This luminous indicator remains on while the ventilator is connected to the 110 to 220 Vac electric network, even when turned off. In case of an electric network failure or disconnection from the network, this indicator turns off. 2 - Manual Cycle Button A button that triggers a new inspiration phase when pressed. 3 - GRAPHICS Key A key that selects the graphic displayed in the monitor. The options of graphics available are described in the item 8.6 of this manual. 4 Stand By Key - STAND BY When this key is pressed for 2 seconds, the ventilator is switched to stand by mode (STAND BY) and the respective visual indication in the monitor is displayed. The ventilator remains inactive , however, it is possible to adjust the ventilation parameters. To cancel this condition the operator must press the STAND BY key again. This mode can be used during the patient preparation or any other special event. 5 FREEZE Key This key freezes the graphic displayed in the monitor, allowing a more detailed analysis of the curves. When pressed again, this key releases the graphic. When this key is pressed, the lower left corner of the monitor displays a symbol (blue circle) indicating the frozen graphic status, however, the alphanumeric window data is still displayed in real time, and the active ventilation values will still be executed. 6 - Hold Insp./Exp. Key This key performs a manual inspiration pause with a duration of 6 seconds and a manual expiration pause of 4 seconds depending on the mode that is active when pressed. 7 - REPEAT Key Redisplays graphically the last 2 respiration cycles without changing the active ventilations options. Manual Code: 204010259_002 47

8 - Oxygen Concentration Key Allows 100% of O2 for a period of 90s. To cancel, press the key again and the previously adjusted value will become active. 9 - MODE Key This key performs the ventilation mode selection within the options: VCV, PCV, PCV/AV , SIMV/V, SIMV/P, BIPV , CPAP and PSV. The key must be repeatedly pressed until the desired mode is highlighted in the monitor, then press the EASY TOUCH button to confirm the selection. 10 - VENTILATOR Key A key for quick access to the selection of the pages where the parameter adjustment options are found, which may be alternated and confirmed by pressing the EASY TOUCH button. 11 - KEYBOARD Key When this key is pressed the keyboard functions are disabled, preventing the accidental activation of others keys. Press the key once to disable and press it again to enable the keyboard.

Note:
The ventilator remains operating normally while the keyboard is disabled.

12 - SAVE Key This key freezes and keeps displayed on the graphics screen a desired flow x volume loop, making it possible to follow -up the improvement or worsening of the patients performance in the next cycles. 13 TREND Key Displays and hides the trend graphic of the monitored ventilation parameters. 14 - MONITOR Key A key for quick access to the selection of the ventilation monitor pages and to alarm adjustments, which may be selected and confirmed by pressing the EASY TOUCH button. 15 - Alarm Silencing Key - SILENCE When an alarm is active, pressing this key will silence the sound alarm system during 2 minutes. An indicator is displayed on the monitor and will remain there while the temporary alarm silencing condition is active. However, if during this period another alarm condition is triggered such alarm will sound again.

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8
8.1

Configuration of the Ventilation Parameters

Self-test Screen

As soon as the ventilator is turned on, the monitor displays the screens of the system initialization and of the software used in the ventilator (this screen is similar to the initialization screen of a common microcomputer). This information is used for the equipments maintenance. After that, the ventilator performs a self -test procedure in the internal valves. The O2 valve is tested first, then comes the air valve and at last both valves are tested together. During the self-test procedure the behavior of the electronic components integrating the system is also assessed. Eventual failures in the system (pneumatic, electronic and gases network), found during the self -test, are warned by means of alarm messages and a sound signal. The self -test procedure takes approximately 20 seconds.

Warning
Do not use the CARMEL Servoventilator if the self-test points out any problem. Solve the problem before using the equipment.

8.2

Initialization Screens

Once the equipment has passed the self -test, a screen that requests the operator to inform the ideal weight of the patient in kilograms, as well as the value of the volume/weight ratio for the current volume (4 to 12 ml/kg) is displayed, so the ventilator may pre-calculate the ventilation parameters (Figure 8 .1). The value of the product of the patient weight times the volume/weight ratio, which represents the current pre-calculated volume, is then displayed. Perform the following procedure to select and confirm such parameters: Example: Suppose the operator informs a weight of 50 kg and introduces a value of 10 ml/kg as the volume/weight ratio. The current pre-calculated volume will then be 500 ml. Use the easy touch key in the control panel to select and confirm the value displayed. Depending on the weight of the patient, the ventilator will indicate the type of patient and will automatically enable the initial modes, in the following way: Weight > 25 kg: mode ADULT, requests adult sensor and the VCV, PCV, SIMV/V and SIMV/P initial modes. 10 < Weight = 25 kg: mode INFANTILE, requests infantile sensor and the VCV, PCV, SIMV/V and SIMV/P initial modes. 6 < Weight = 10 kg: mode INFANTILE, requests infantile sensor and the PCV and SIMV/P initial modes. Weight = 6 kg: mode NEWBORN, requests infantile sensor and the PCV and SIMV/P initial modes. In the newborn mode, the modes available are: PCV, SIMV/P, BIPV , CPAP and PSV. The ventilator will request the connection of the flow sensor type most adequate to the weight of the adult or infantile patient (Figure 8.1).

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Figure 8.1. Current Volume calculation screens The operator may choose the initial mode by positioning the EASY TOUCH button over the desired mode and pressing it to confirm. The VCV, PCV, SIMV/V and SIMV/P are among the modes available (Figure 8.2).

Figure 8.2. Initial mode selection. The next adjustment will be the operation mode. By pressing the EASY TOUCH button over the Mode item the options available may be selected by rotating the EASY TOUCH button (Figure 8.3). Pressing the EASY TOUCH button does the confirmation. The options available are: Basic: Makes available only the VCV. PCV, SIMV/P and SIMV/V modes. Complete : Makes all the modes available.

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Figure 8.3. Mode selection. The next adjustment will be the parameters used. By pressing the EASY TOUCH button over this parameter the options available may be selected by rotating the EASY TOUCH button (Figure 8.4). Pressing the EASY TOUCH button does the confirmation. The options available are: Previous: Uses the parameters selected before the equipment is turned off, disabling the suggestions recently performed. Adjusted: Uses parameters according to the recently selected weight and volume.

Figure 8.4. Parameter selection. The next adjustment will be the language. By pressing the EASY TOUCH button over this parameter the options available may be selected by rotating the EASY TOUCH button (Figure 8.5). Pressing the EASY TOUCH button does the confirmation. The options available are: Portuguese, English and Spanish.

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Figure 8.5. Language selection. Once the previous adjustments are completed, pressing the EASY TOUCH button over OK carries out the confirmation. The appropriate sensor must be connected according to the request. An assembly diagram of the respiration loop will be displayed.

Figure 8.6. Confirmation of the initial adjustments and release for operation.

Warning
The automatic initial adjustment of the ventilation parameters must not be considered by the operator as the ideal and definitive adjustments for the patient. Before starting the ventilation, be sure to perform the ideal adjustment for each parameter. Check the correct position of the external flow sensor. The sensor is used in the distal mode for adult and infantile patients and in the proximal mode for newborn patients. According to the weight selected in the screen above, the loop assembly is displayed on the next screen according to the type of patient.

The ventilator will then display the main screen and will start the ventilation and monitoring.

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8.3

Main Screen

The main screen (Fig 8.7) displays essential functions as: Upper bar: Value entered for the patient weight. Right side: Adjustment of ventilation parameters. Left side: Alarm monitoring and adjustment. Central part: Graphic presentation of the ventilation parameters in real time. Lower bar: Status of the equipment and alarm messages.

Figure 8.7. Main control screen.

8.4

Messages

Messages may show up in the lower part of the screen, as described below:

v ELECTRIC NETWORK DOWN - BATTERY IN USE

Indicates that the internal battery is powering the ventilator, with no power from the electric network. Therefore, it is necessary to connect the ventilator to another external electric power source before battery charge ends (approximately 120 minutes considering maximum battery charge).

v Alarm Sound Off

Indicates that the user has requested the inhibition of the sound alarm for up to 120s, provided no other different or new alarm condition shows up.

v LIMITED PRESSURE
Indicates that the ventilation is being limited by the inspiration pressure limit control, in the VCV, SIMV/V, or PCV/AV modes.

Warning
While the LIMITED PRESSURE option is displayed on the monitor, the actual volume supplied to the patient is lower than the value adjusted with the EASY TOUCH button.

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v ASSISTED -> FLOW TRIGGER

ASSISTED -> PRESSURE TRIGGER ASSISTED -> MANUAL TRIGGER Message that shows up momentarily on the lower part of the monitor every time the patient triggers a ventilator cycle, including an indication in red, where this option is found, of whether the triggering was due to FLOW, PRESSURE or the pressing the MANUAL CYCLE key. This message allows the visual follow -up in the graphics of the patients capacity to trigger the ventilator cycles, making the adjustment of the sensibility controls easier whether per pressure or per flow.

v SPONTANEOUS -> FLOW TRIGGER

SPONTANEOUS -> PRESSURE TRIGGER Message that shows up momentarily on the lower part of the monitor every time the patient starts a spontaneous respiration cycle with the help of the Support Pressure, also including an indication of whether the sensibility was due to FLOW or PRESSURE.

v SPONTANEOUS
Message that shows up momentarily on the lower part of the monitor every time the patient starts a pure spontaneous respiration cycle, also including an indication of whether the sensibility was due to FLOW or PRESSURE.

v WINDOW
Message that shows up momentarily on the lower part of the monitor during the period in which the ventilator waits for the patients inspiration effort to trigger a new respiration.

v AUTO PEEP =
Message indicating the auto-PEEP value measured by the CARMEL. Refer to Chapter 12 to get additional information about this special function of the CARMEL Servoventilator.

v MANUAL EXPIRATION PAUSE

Message indicating that the ventilator will be in expiration pause during 4 seconds after the expiration time, for the purpose of measuring the auto-PEEP.

v MANUAL INSPIRATION PAUSE

Message indicating that the special 5-second inspiration pause function is in progress.

v CONTROLLED PVC
Message indicating that the ventilator has entered automatically in the backup mode, because the patient has stopped to breath spontaneously or is not being able to trigger the ventilator.

v STAND BY
Message indicating that the ventilator is in the stand by mode (STAND BY), which is activated by pressing the STAND BY key.

v RELIEF
Message indicating that the ventilator is using the programmed relief resource. In this region of the screen (right) a menu for the selection of the ventilation parameters is displayed. (Figure 8.8). All the adjustments in this menu are easily activated with the help of the EASY TOUCH keys to select and confirm, MODE key to change the ventilation mode and the ventilators page selection button (VENTILATOR) to change the options of this menu. To adjust the items of this screen, the procedures described in item 10.2 shall be followed:

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8.5

Monitoring Functions

The Ventilation Monitoring functions incorporated to the CARMEL Servoventilator are concentrated in the left portion of the monitor. In this screen can be found the functions that monitor the ventilation parameters in real time and manage a complete alarm system.

Figure 8.8. Monitoring screens (presented separately).

Notes:
Depending on the configuration chos en, small differences between the parameters displayed on the screen and those shown in Figure 8.8 may exist.

8.6

Graphics Window

The selection of the graphic to be displayed is made using the GRAPHIC key. The graphics available for display are listed in the table below. GRAPHIC Flow x time Pressure x Time Volume x Time Pressure x Flow Volume x Pressure UNIT l/mim x s cmH2O x s ml x s l/mim x ml ml x cmH2O

To exchange the screens among the types of graphic available, press the quick access GRAPHIC button in the control panel.

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Figure 8.9. Graphics: Volume x Time, Flow x Time and Pressure x Time. Loops: Volume x Pressure and Flow x Volume. The storing of a cycle on a certain instant can be carried out in the graphics displayed in loop form (Flow x Volume and Volume x Pressure), for later comparison with the present cycles. Therefore, press the SAVE key in the Front Panel at the desired instant; the graphic then displays the moment in which the cycle is stored in the memory (M HH:MM). The cycles are always displayed in the following sequence: 1. 2. 3. Clears screen Displays curve stored in the memory Displays three cycles in real time, and returns to item 1 above.

Image Freezing
The FREEZE key freezes the graphic being displayed, thus allowi ng a more detailed analysis of the curves. Press the FREEZE key again to release the graphic. When this key is pressed, a blue symbol is displayed beside the instantaneous current volume indicating the frozen graphic status, however, the monitoring screen data is still displayed in real time.

Data Transmission (optional item)

The ventilator is supplied with a serial port for synchronization with another CARMEL Servoventilator using the ILV function through the appropriate cable (this item is optional) and for updating the equipments software. This interface if located in the rear panel of the CARMEL Servoventilator (item 5.6).

8.7

Trend Screen (Graphic)

The trend screens provide a ventilation history, displaying the last values of the measured parameters; these values are stored in the ventilator memory and displayed in the form of graphics or table. Eventual alarms activated during the data storage period are also displayed in the trend table screen. The quick access TREND key inserts in the left side of the graphic being displayed, a summarized history graphic, covering the entire ventilation from the start. Fig (8.10) The available trend screens are described below. To select the desired screen, use the quick access TREND key. Volume graphic Pressure graphic Flow graphic Table with numeric values (DATABASE)

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Fig. 8.10: Trend graphics. This screen can display other graphic options.

8.8

Database

This screen allows the verification of all the monitored parameter values, where each value is stored every 30 seconds during 48 hours, meaning a storage capacity of 5760 registers. When entering the trend table screen (DATABASE), a table where the columns correspond to the parameters is displayed: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Date Hour Mode Current Volume Frequency Maximum pressure Plateau pressure Average pressure PEEP Maximum inspiration flow Maximum expiration flow Work Static complacency Dynamic complacency Resistance FiO2 Alarm 1 Alarm 2

To display this screen, press the quick access GRAPHIC key until the screen is displayed.

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Fig. 8.11 Database To access the database values perform the following procedure: 1. 2. 3. Press the GRAPHIC key the database is displayed (Figure 8.11); Rotate the EASY TOUCH button to the right or left to choose the access to +50, 50, +100, 100, +1000, 1000 data items; To view item by item, take the cursor up to the button (that turns red), press the EASY TOUCH button and rotate it to the left or right to view the parameters. To exit press the EASY TOUCH button again.

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OPERATION

Warning
When using the ventilator, check the flow sensor for cleanliness frequently. The automatic initial adjustment of the ventilation parameters must not be considered by the operator as the ideal and definitive adjustments for the patient. Before starting the ventilation, be sure to perform the ideal adjustment for each parameter.

9.1

Initial Procedures and Tests

Provide a balloon with complacency and resistances values according to IEC60601-2-2-12:2004 Table 10.1. These tests shall be performed mandatorily with this balloon. Perform the assembly procedures described in Chapter 6. Turn the ventilator on, choose the patient weight and observe the ventilator cycling. Disconnect the electric network source cable. Check whether the network led is on and the sound and visual alarms in the display (ELECTRIC NETWORK DOWN - BATTERY IN USE ). Reestablish the electric power. Disconnect the O2 network and check the sound and visual alarms (O2 PRESSURE LOW). Reestablish the O2 network. Disconnect the air network and check the sound and visual alarms (AIR PRESSURE LOW). Reestablish the air network. Disconnect the trachea from the PATIENT connection in the expiration valve and check the sound and visual alarms of ( DISCONNECTION). Obstruc t this trachea, in a sterile way, and check the sound and visual alarms of (VALVE EXP OBSTRUCTION) and the depressurization of the system after the pressure limit is reached. Reconnect the trachea. Disconnect one of the flow sensor tubes and check the audio visual alarm (CHECK FLOW SENSOR). Reconnect the flow sensor tube. Adjust the PEEP value to match the pressure limit and check the visual alarm (PEEP = PRESSURE LIMIT). Return to the PEEP value initially suggested. Adjust the flow value to half the sugges ted value and check the visual alarm (INVERTED RATIO). Adjust the flow value to half the previous value and check the audio visual alarm (4:1 RATIO). Return to the flow value initially suggested. In the alarm menu, adjust the min. pressure value to a value higher then the one reached during the inspiration (use the Pxt graphic as reference) and check the audio visual alarm (PRESSURE LOW). Return to the min. pressure value initially suggested.

In the alarm menu, adjust the max. pressure value to a value lower then the one reached during the inspiration (use the Pxt graphic as reference) and check the audio visual alarm (PRESSURE HIGH). Return to the max. pressure value initially suggested.

In the alarm menu, adjust the min. peep value to a value higher then the one reached during the inspiration (use the Pxt graphic as reference) and check the audio visual alarm ( PEEP LOW). Return to the min. pressure value initially suggested.

In the alarm menu, adjust the max. peep value to a value lower then the one reached during the inspiration (use the Pxt graphic as reference) and check the audio visual alarm ( PEEP HIGH). Return to the max. pressure value initially suggested.

In the alarm menu, adjust the min. frequency value to a value higher then the one reached and check the audio visual alarm (FREQUENCY LOW). Return to the min. frequency value initially suggested. In the alarm menu, adjust the max. frequency value to a value lower then the one reached and check the audio visual alarm (FREQUENCY HIGH). Return to the max. frequency value initially suggested.

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In the alarm menu, adjust the value of the min. minute volume to a value higher then the one reached during the inspiration (use the Vxt graphic as reference) and check the audio visual alarm (MINUTE VOLUME LOW). Return to the min. minute volume value initially suggested.

In the alarm menu, adjust the max. minute volume value to a value lower then the one reached during the inspiration (use the Vxt graphic as reference) and check the audio visual alarm (MINUTE VOLUME HIGH). Return to the max. minute volume value initially suggested.

Switch to the CPAP mode confirming all the parameters. Perform stimuli in the balloon and check whether, when the stimulus ceases and the apnea time is activated, the APNEA audio visual alarm is activated.

Warning
Do not use the CARMEL Servoventilator if the self-test indicates any problem. Solve the problem before using the equipment.

9.2

Adjustment of the Ventilation Parameters

The ventilation parameters adjusted by the operator are continuously displayed on the right side band of the monitor, on the control screen. Through the quick access VENTILATOR (16) key in the control panel, or using the EASY TOUCH (17) button, the parameters that feature quick access for adjustment may be viewed.

Note
For more information about the ventilation parameters, refer to the description of the respective quick access adjustment keys, in item 7.1 - Control Panel. Chapter 3 - Technical Specifications - informs the variation ranges for the adjustment of the ventilation parameters.

The control screen displays on its right side the selected ventilation mode among the following options: VCV, PCV, PCV/AV , SIMV/V, SIMV/P, BIPV , CPAP and PSV. Chapter 11 - Ventilation Modes describes in detail all the ventilation modes available.

v Mode
To select the type of ventilation mode desired, press the quick access MODE button, this will cause the present ventilation displayed on the screen to be highlighted (blue background), keep pressing the button until the desired mode is displayed and confirm by pressing ENTER in the EASY TOUCH button.

v Ventilation Mode Parameters

To change the value of the options shown in the following table, press the quick access key to the ventilator pages (VENTILATOR), select and confirm the item to be changed using the EASY TOUCH button, the selected item is highlighted (blue background), perform the adjustment rotating the button on the clockwise or counter-clockwise directions and confirm the adjustment pressing the EASY TOUCH button. Refer to the Technical Specifications chapter.

Note:
To access the other options of this menu (pages), press the ventilator quick access key. This table displays all the parameters of all of the ventilation modes, where each ventilation mode presents different sets of ventilation parameters.

v Inspiration Pause Adjustment

Adjusts the inspiration pause time to provide an inspiration plateau in the controlled volume ventilation modes. The adjustment is performed directly in seconds through the EASY TOUCH button.

Note:
The value of the I/E ratio is influenced by the adjustment performed in the inspiration pause control. After the ventilation starts, check whether the I/E ratio value indicated by the monitoring display is adequate.

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v Adjustment of the Pressure-Assisted Sensibility

Adjusts the negative pressure level (trigger ) necessary for the patient to trigger ventilator cycle. This control is available in all ventilation modes. The adjustment is performed directly in cmH2O (negative pressure), through the EASY TOUCH button.

Notes:
The value adjusted by this control refers to the negative pressure level below the PEEP value. The triggering of the cycles by the patient can also be achieved by both the measurement of the pressure fall (pressure trigger) and the measurement of the inspired flow (flow trigger), according to the pressure and flow sensibilities adjusted. The sensibility by flow is adjusted on the control configuration screen. The condition that first occurs, between pressure trigger and flow trigger, will be valid. In order to make the correct sensibility adjustment easier, an assisted or spontaneous trigger message shows up momentarily on the configuration screen every time the patient succeeds in triggering a ventilator cycle.

v PEEP/CPAP Adjustment
Adjusts the PEEP/CPAP value. The adjustment is performed directly in cmH2O, through the EASY TOUCH button. In the CPAP mode, this control adjusts the continuous positive pressure value in the aerial passages (CPAP). In other modes, this control adjusts the value of the positive expiration end pressure (PEEP).

v Adjustment of the Inspiration Pressure Limit

Adjustment of the maximum inspiration pressure limit. The adjustment is performed directly in cmH2O, through the EASY TOUCH button.

Note:

In the PCV/ PLV, BIPV level 2 and SIMV/P modes these controls adjust the maximum work pressure value. In the VCV, SIMV/V and PCV/AV modes this control acts as maximum limited safety pressure against barotrauma due to excessive pressure.

v Support Pressure Adjus tment

The Support Pressure Adjustment is used in several ventilation modes. The adjustment is performed directly in cmH2O (negative pressure), through the EASY TOUCH button. The value of the adjusted Support Pressure is absolute, this means that, regardless of the existence or not of PEEP, it will be started based on zero. Example: Observing the figure below we can tell that when a Support Pressure of 20cmH2O is adjusted using a PEEP of 3 cmH2O, the inspiration pressure will not be 20+3=23 cmH2O, because, as previously mentioned, the Support Pressure is an absolute value with reference on zero, therefore, the inspiration pressure will be the same 20 cmH2O.

Example of Absolute Support Pressure

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v Support Pressure Cycling

In the Support Pressure ventilation, this adjustment will determine the ventilator cycling as soon as the inspiration flow is reduced and reaches the adjusted percentage of its peak value. The adjustment is performed in flow percentage, through the EASY TOUCH button.

v Rise Time
In the pressure-controlled ventilation (including Support Pressure) this adjustment determines how quickly the pressure applied to the patient will be established/achieved. The adjustment is performed in seconds, through the EASY TOUCH button.

v Maximum Inspiration Flow Adjustment

Adjustment of the maximum flow value during the inspiration phase. The adjustment is performed directly in liters per minute through the EASY TOUCH button.

Notes:
In the VCV and SIMV/V modes, the Maximum Inspiration Flow and the Current Volume determine the inspiration time. After the ventilation is started, check whether the value resulting from the inspiration time indicated on the ventilator monitor is adequate. In the pressure-controlled modes, the Maximum Inspiration Flow option is not active and the maximum inspiration flow supplied by the equipment during the inspiration is FREE, according to the need to keep the pressure adjusted in the ventilator control panel constant.

v Respiration Frequency Adjustment

Adjustment of the respiration frequency. This adjustment is performed directly in respirations per minute, through the EASY TOUCH button.

Notes:
In the VCV and SIMV/V modes, the respiration frequency determines the I/E ratio. After the ventilation is started, check whether the I/E ratio displayed on the ventilator monitor is adequate. In some modes, the patient itself normally determines the frequency and the adjustment of this control defines only the value of a safety respiration frequency.

v Inspiration Time Adjustment

Adjustment of the inspiration time. The adjustment is performed directly in seconds, through the EASY TOUCH button.

Notes:
The option of inspiration time adjustment is not active in the VCV and SIMV/V modes, because the inspiration time will result from the adjustment of the other ventilator controls. The I/E ratio value is influenced by the adjustment performed in the inspiration time control. After the ventilation is started, check whether the I/E ratio displayed on the ventilator monitor is adequate. The maximum inspiration time adjustment allowed is limited to 80% of the respiration cycle, this means that, if the respiration frequency used is 10 rpm, then the respiration cycle will be 6.0 seconds, therefore, the maximum inspiration time allowed for this frequency will be limited to (0.8*6.0) = 5.40 seconds.

v Volume Adjustment
In the VCV, PCV/AV and SIMV/V modes this option adjusts the current volume desired. The adjustment is performed directly in milliliters, through the EASY TOUCH button.

Warning
When the ventilation is limited by the inspiration pressure limit control, the message LIMITED PRESSURE is displayed (in the VCV, SIMV/V and PCV/AV modes) and the actual value of the current volume supplied to the patient is lower than the one indicated by this current volume control.

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v Flow Type
Selects the type of flow curve during inspiration for the mandatory cycles in the VCV and SIMV/V modes. The options available are four: Square curve (SQUARE) ........................................ the flow is maintained on a constant value during inspiration. Accelerated curve (RISE) ....................................... the inspiration flow starts with a low value and then rises linearly up to a maximum value during inspiration. Decelerated curve (FALL)...................................... the inspiration flow starts with a maximum value and falls linearly up to a lower value during inspiration. Sinusoidal curve (SINUS) ...................................... the inspiration flow increases and falls according to a sinusoidal curve.

v Basic Flow
Adjusts the value of the flow that passes through the respiration loop during the expiration phase. The main application of this f low is as wash flow for the elimination of the respiration loop carbonic gas during expiration.

Note:
The expiration flow can never be higher than the value adjusted in the maximum inspiration flow control. The basic flow adjustment range is of 4 to 40 l/min.

v Flow Trigger (Sensibility to Flow)

Adjusts the flow value that the patient shall inspire (flow -assisted sensibility) to succeed in triggering a ventilator cycle. This control is available in all ventilation modes. Adjustment range = 1 to 30 l/min, and turned off in OFF (default=OFF)

Note:
The triggering of the cycles by the patient can be performed by both the measurement of the pressure fall and the measurement of the inspired flow (flow trigger), according to the pressure and flow sensibilities adjusted by the operator. The condition that first occurs, between pressure trigger and flow trigger, will be valid and displayed on the monitor.

v Nebul / TGI
The options presented for these parameters are: OFF turns off the Nebulizer and TGI operation. NEB - activates the Nebulizer and the nebulization flow is automatically supplied during the inspiration phases (approximately 7 l/min). TGI - activates the TGI and the TGI flow is automatically supplied on the end of the expiration phases (approximately 7 l/min).

v Relief
The relief can be programmed to take place every 5 to 100 cycles. With the relief resource programmed, the ventilator operates in the following way: In the volume-controlled modes and regardless of the flow curve type, the ventilator will increase in 50% the active inspiration time (without pause), resulting on a 50%-increase in the current volume in each number of cycles programmed. In the pressure-controlled modes, the ventilator will increase in 50% the inspiration time, without increase in the current volume in each number of cycles programmed.

v Clock
Adjusts clock with the correct time. The hour (HH) and minute (MM) adjustments are done separately and menu displays the time in the HH:MM form.

v Apnea Time
Adjusts the delay time for the triggering of the apnea alarm. If the patient remains without breathing for a time longer than this value, the apnea alarm will be activated and the ventilator enters in the backup ventilation mode. The APNEA message shows up blinking in red in the lowe r region of the screen (equipment status). Default adjustment: 10 seconds.

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v Audio Volume
Adjusts the volume of the monitors audio signals within a scale of 2 to 10. Default adjustment (4).

Notes:
When the ventilator is turned off, the alarm adjustments are not stored in the memory. When the ventilator is turned on again, such adjustments assume the default values (original from the factory). The adjustment intervals for each one of the parameters above are described in Chapter 3 - Technical Specificati ons.

v O2 Cal Cell
Calibrates the cell/oxygen sensor to the concentrations of 21 and 100% of oxygen.

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10

ALARM SYSTEM

The CARMEL ventilator contains a complete system of audiovisual alarms, providing great ventilation safety. In case of any alarm condition, the Ventilator emits Sound Signals and places written Messages on the screen, to assist the operator in the quick identification of the problem that generated the alarm.

Note:
The ventilator alarms system is in accordance with the ISO 9703-1, ISO 9703-2 and ISO 9703-3 standards .

The intensity and frequency of the alarm indication are directly related to the priority level of the event, as specified below.

10.1

Alarm Priority Levels

The Alarm System of the CARMEL Servoventilator can be activated by two different sources of control: the ventilator and the ventilation monitor incorporated to the equipment. The alarms with greater priority, active (which interrupt the ventilation cycle) and considered as safety issues are linked to the ventilator, and the secondary alarms or considered as alert conditions are linked to the ventilation monitor. The alarms, which are shown on the ventilator display, meet the following pattern: Medium Priority alarms are highlighted with Yellow color background and Black letters, while High Priority alarms are highlighted with Red color background and White letters. Priority Level 1 (high) 1. Battery Low 2. Obstruction (Active) 3. See Line and Sensor 4. High pressure (Active) 5. Apnea 6. Disconnection 7. O2 Pressure Low 8. Air and O2 Pressure Low Priority Level 2 (Medium) 1. High pressure 2. PEEP Alert =Limit Pressure (without audio) 3. High FiO2 4. Low FiO2 5. I:E > 4:1 6. Inverted I:E Ratio Alert (without audio) 7. PEEP Low 8. PEEP High 9. High Frequency 10. Low Frequency 11. Minute Volume Low 12. Minute Volume High 13. Low Pressure

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2. Sound Differentiation Among the Alarm Priority Levels

According to the priority level of the generating event, the alarms feature differentiated sound signals and frequency, always in a decreasing order of importance: COM1 FAILURE -BATTERY LOW, EXP OBSTRUCTION, CHECK LINE AND SENSOR, HIGH PRESSURE, DISCONNECTION, APNEA, O2 PRESSURE, AIR PRESSURE Remaining Alarms
2

Continuous Sound Intermittent Sound rings every 10s

Intermittent Sound

rings every 22s

The alarms linked to the CARMEL Servoventilator control screen are:

v Check O Network
2

Indicates a low -pressure condition in the oxygen netw ork that supplies the Ventilator. In this condition the ventilator starts operating with compressed air only and the O2 concentration at 21% is shown in the Ventilator control panel. When the O2 network is reestablished the O2 concentration in the control panel must be readjusted to the desired value.

v Check AIR Network

Indicates a low -pressure condition in the compressed air system that supplies the Ventilator. In this condition the ventilator starts operating with O2 only and the O2 concentration at 100% is shown in the Ventilator control panel. When the compressed system is reestablished the O2 concentration in the control panel must be readjusted to the desired value. In the Air Compressor configuration (optional) this alarm will also indicate a low -pressure condition in its reservoir.

v Disconnection
Indicates a disconnection in the respiration loop or in the flow sensor tubes .

v Apnea
Indicates that the patient stopped breathing spontaneously, therefore an immediate action by the operator is required. Depending on the selected mode, the Ventilator enters automatically in the backup mode.

v High Pressure
1. Indicates that the actual inspiration pressure exceeded by 5 cmH2O the value adjusted in the inspiration pressure limit control, due to some abnormal operating condition. This is an active alarm that interrupts the inspiration automatically to avoid excessive pressure. 2. Indicates that the inspiration pressure exceeded the adjusted upper limit value of the ventilation monitor alarm.

v Low Pressure
Indicates that the inspiration pressure is not reaching the lower limit established in the ventilation monitor alarm menu.

v Inverted Ratio (visual alarm)

Indicates an inverted ratio ventilation condition, with an inspiration time higher than the expiration time. This is a visual only alarm, because the operator might eventually desire such condition. In volume-controlled modes the ventilator is provided with a safety system that prevents an adjustment that results in a I:E ratio higher than 4:1.

v I:E >4:1
Indicates an inverted ratio ventilation condition higher than 4:1, being the inspiration time higher than or equal to 4 times the expiration time.
1 2

The COM FAILURE alarm does not display any message on the screen. The Inverted Ratio and PEEP=Limit Pressure alarms dont have sound signals.
66

Manual Code: 204010259_002

v PRESS LIM = PEEP (visual alarm)

Indicates an adjustment condition where the limit pressure is equal to the PEEP. This is a visual only alarm, because the operator might eventually desire such condition.

v PEEP High
Indicates that the pressure in the end of the expiration exceeded the upper limit established in the ventilation monitor alarm menu.

v PEEP Low
Indicates that the pressure in the end of the expiration did not reach the lower limit established in the ventilation monitor alarm menu.

v Minute Volume High

Indicates that the measured minute volume exceeded the upper limit established in the ventilation monitor alarm menu.

v Minute Volume Low

Indicates that the measured minute volume did not reach the lower limit established in the ventilation monitor alarm menu.

v Frequency High
Indicates that the measured respiration frequency exceeded the upper limit established in the ventilation monitor alarm menu.

v Frequency Low
Indicates that the measured respiration frequency did not reach the lower limit established in the ventilation monitor alarm menu.

v FiO

High

Indicates that the measured FiO2 exceeded the upper limit established in the ventilation monitor alarm menu.

v FiO Low
2

Indicates that the measured FiO2 did not reach the lower limit established at the ventilation monitor alarm menu.

v Electric Network Down Battery in use

Indicates that the internal battery is supplying the Ventilator, without power from the electric network. It is then necessary to connect the Ventilator to another external power source, before the battery charge finishes (approximately 120 minutes with maximum battery charge).

v Battery Low
Indicates that the internal battery charge is low and the battery must be urgently recharged. The visual indication of this alarm is made through the BATTERY (4) visual indicator. This alarm has medium and high priority.

Warning
The Ventilator must be immediately connected to the electric network when this message appears, in order to recharge the internal battery.

v EXP Obstruction
Indicates an obstruction of the expiration valve, it may have been caused by the folding or obstruction (secretions) of the expiration branch or even by problems in the expiration valve diaphragm (assembly, integrity and cleaning).

v Check Line and Sensor

Indicates that a disconnection or obstruction has occurred in the flow sensor tubes (blue or colorless).

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11

VENTILATION MODES

The Table below shows the ventilation modes available in the CARMEL Servoventilator. The modes that require an inspiration effort from the patient to trigger the respirations are provided with a protection system against apnea, with automatic switching to another backup mode. This resource results in higher safety for the patient.

Adjusted mode

Description

Ventilation in Apnea (Backup)

1.

VCV

Ventilation in Apnea (Backup)

Not Applicable

PCV 2. PLV 3. 4. PCV/AV SIMV/V SIMV/P BIPV CPAP PSV

Pressure-Controlled-ventilation Pressure-Limited Ventilation Volume Ventilation Ensured by Pressure Control Synchronized Intermittent Mandatory Ventilation with Volume Control Synchronized Intermittent Mandatory Ventilation with Pressure Control Spontaneous Ventilation with Two Pressure Levels Ventilation with Continuous Positive Pressure in the Aerial Passages Ventilation with Pressure Support

Not Applicable Not Applicable Not Applicable IMV (not synchronized)

5.

IMV (not synchronized)

7. 8. 9.

Not Applicable Not available if needed use PSV PCV

Notes:

In the NEWBORN mode (patient weight = 6 kg), the modes available are: PLV, SIMV/P, BIPV, CPAP e PSV. The switching to the backup ventilation occurs after the patient stops breathing for a time above the apnea time adjusted in the configuration part of the monitoring, together with the acti vation of the apnea alarm. After the adjustment of the last ventilation parameter on the configuration screen, press the EASY TOUCH button once to start the mechanical ventilation in the selected mode, when desired.

11.1

Mandatory and Spontaneous Cycles

During the utilization of the CARMEL Servoventilator, the respiration cycles can be classified as mandatory or spontaneous, and the combinations between both form the several ventilation modes available.

Mandatory cycles
In the mandatory cycles, the operator adjusts the ventilation parameters that define the inspiration and expiration times, current volume and other variables. Therefore, the patient does not have control over what occurs during the inspirations . There are two ways to trigger the start of each inspiration: a) b) Triggering by the ventilator - The ventilator determines the start of each cycle and, therefore the respiration frequency, Triggering by the Patient - The patient determines the start of each cycle and, therefore the respiration frequency, through

according to the controls adjusted by the operator. These cycles are found in the controlled-ventilation mode. an inspiration effort. The effort level required to trigger the ventilator is determined by the sensibility of the controls triggered by pressure or flow .

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Spontaneous cycles
In the spontaneous cycles, the patient has active participation in what occurs during the inspiration. Two kinds of inspiration are available for spontaneous cycles : a) b) Pressoric support - During inspiration the pressure is maintained in a constant level adjusted by the operator in the Pure spontaneous - The ventilator does not cycle, and the patient breathes spontaneously over a positive pressure

pressoric support pressure control. The ventilator supplies, at every moment, the necessary flow to meet with the patient's demand. maintained by the ventilator in the respiration loop. This pressure can be maintained in a single constant level (CPAP) or vary between two different levels (BIPV ).

Adjustment of the sensibilities

The effort level required from the patient to trigger the ventilator can be determined by the pressure drop measurement (pressure trigger) as well as by the inspired flow measurement (flow trigger), according to the adjusted sensibilities. The condition that first occurs, between pressure trigger and flow trigger, will be valid. Sensibility to pressure is adjusted through the monitoring screen. Sensibility to flow is adjusted on the control monitor configuration screen.

To facilitate the correct sensibility adjustment, an assisted or spontaneous triggering message appears momentarily on the configuration screen every time the patient succeeds in triggering a ventilator cycle.

11.2

Selection of the Ventilation Modes

The ventilation mode selection is accomplished through the MODE key (13), located in the front panel of the CARMEL Servoventilator. This key allows the selection of the desired mode, among the options VCV, PCV, PCV/AV , SIMV/V, SIMV/P, BIPV , CPAP and PSV, through the procedure described below . 1. 2. 3. Press successively the MODE key until the desired mode appears on the configuration screen. Press the ENTER key (EASY TOUCH) to confirm the selection made. The new mode now selected will only be active after all the parameters are confirmed, in order to prevent any accidental

parameter change.

Active controls
For each ventilation mode selected in the CARMEL, the control screen only shows the values of the active parameters in the selected mode; the spaces destined to the inactive parameters are filled with ......... This characteristic makes adjusting the CARMEL a very easy, fast and safe operation.

11.3

VCV - volume-controlled ventilation

In the volume-controlled ventilation mode (VCV), the ventilator seeks to deliver to the patient a predetermined value of current volume. The cycles can be of two different kinds, with regard to the start of the inspirations: 1) Controlled cycles - The patient is passive and the apparatus fully controls the ventilation. The operator adjusts the cycles

and the desired value of the current volume, thus performing a volume-limited ventilation. The inspiration pressure control limit acts as safety precaution against barotrauma. 2) Assisted cycles - The start of each cycle and the respiration frequency are determined by the patients inspiration effort,

which triggers the respirations. In case the patient enters in apnea, or does not succeed in triggering the apparatus due to a very heavy sensibility adjustment, the ventilator starts supplying controlled cycles with the frequency value adjusted in the respective control. In face of a new patient stimulus, the ventilation will return automatically to the assisted cycles.

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Warning
After starting the ventilation, check whether the values resulting from the inspiration time and the I/E ratio, indicated by the monitoring region, are adequate, as well as the other ventilation parameters. If necessary, readjust the ventilator controls. In case the ventilation is being limited by the inspiration pressure control limit, the actual volume supplied to the patient is smaller than the value adjusted by the ventilator current volume control, and this condition is pointed out on the configuration screen by the message LIMITED PRESSURE.

P (cmH2
O)

T. INS

T. EXP

PEE P 0

PRESS. TRIGGER

F (l/mi
n)

FLO W

0
FLO TRIGGE W R T. PAUSE

Figure 11.1. VCV Mode: examples of curves: pressure x time and flow x time. Figure 11.1 shows pressure and flow curves in function of time, to assist in the understanding of the VCV mode. The start of each respiration can be controlled by the ventilator or by the patient, and in this latter case the trigger can be conducted by pressure or by flow. During the inspiration the flow takes the wave shape defined by the operator, and the pressure rises until the adjusted current volume is delivered (or until the limit pressure is reached). An inspiration pause can be used.

11.4

PCV - pressure-controlled ventilation

This mode is a variation of the VCV ventilation, and the basic difference between both is the way the cycling and inspiration pressures are controlled. In the PCV, the operator determines the inspiration pressure value and not the current volume. The ventilator supplies at every moment the gas quantity required by the patient to keep the inspiration pressure constant, according to the value adjusted in the inspiration pressure control limit (12). This mode is recommended, for example, in the case of a significant leak in the endotracheal tube and in patients with resistance / complacency differences between parts of the lungs . This mode can work basically in two different ways, with regard to the inspiration start: 1) 2) In normal PCV conditions, the start of each cycle and the respiration frequency are determined by the patients inspiration In case the patient enters in apnea, or does not succeed in triggering the apparatus due to a very heavy sensibility

effort, which results in an assisted ventilation. adjustment, the ventilator starts supplying mandatory cycles with the value adjusted in the frequency control (23). In face of a new patient stimulus, the ventilation returns automatically to the normal patient-trigger condition. The following ventilation parameters shall be adjusted in the PCV (in the sequence in which they are placed in the adjustment mode by the ventilator):

Warning
After starting the ventilation, check whether the respiration parameters indicated by the monitoring region are adequate. If necessary, readjust the ventilator controls.

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PRESSURE LIMIT PEE P 0

T. INS

1/ FREQ

5 2 cmHO

PRESS. TRIGGER

F (l/mi
FLO W n)

0
FLO TRIGGE W R

Figure 11.2. PCV Mode: examples of curves: pressure x time and flow x time. Figure 11.2 shows pressure and flow curves in function of time, to assist in the understanding of the PCV mode. The start of each respiration can be controlled by the ventilator or by the patient and, in this latter case, the trigger can be by pres sure or flow. In the start of inspiration, the flow reaches its maximum value, and then falls until the end of the inspiration time. The pressure is maintained constant during the inspiration. If, for any reason, the actual inspiration pressure exceeds by 5 cmH2 O the adjustment of the inspiration pressure limit, a high-pressure alarm is deployed and the inspiration is automatically interrupted.

11.5

PLV pressure-limited ventilation

This type of ventilation is used only for newborn patients . In this mode the ventilator cycles on time with continuous flow. During the ventilation, the mandatory cycles can be of two different kinds, with regard to the start of inspirations : 1) 2) Controlled cycles: the patient is passive and the apparatus fully controls the ventilation. Assisted cycles: the start of each cycle and the respiration frequency are determined by the patient's inspiration effort,

which triggers the respirations. In case the patient enters in apnea, or does not succeed in triggering the apparatus due to a very heavy sensibility adjustment, the ventilator starts supplying controlled cycles with the frequency value adjusted in the respective control. In face of a patient's new stimulus, the ventilation returns automatically to the assisted cycles.

Note:
When the triggering of the cycles by the patient is desired, adjust the respiration frequency control to a value smaller than the patient's spontaneous frequency. The patient can trigger the cycles by pressure or flow, depending on the sensibility value of the assisted. If the operator disables the sensibility, then all cycles will be obligatorily controlled.

FLOW

Figure 11.3: PLV Mode: Examples of curves: pressure x time and flow x time. PLV pressure-limited ventilation charts

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Figure 11.3 shows the pressure and flow curves in function of time, to assist in the understanding of the PLV pressure-limited ventilation mode. During inspiration the pressure rises until it reaches the adjusted inspiration pressure limit, in the start of the inspiration the flow reaches its maximum value, then falling until the end of the inspiration time (decreasing flow), thus performing a plateau until the expiration start. If for any reason, the actual inspiration pressure exceeds by 5 cmH2O the inspiration pressure limit adjustment, a high-pressure warning will be deployed and the inspiration will be automatically interrupted.

Warning
In the ventilation limited by maximum pressure, the actual volume supplied to the patient will be smaller than the value adjusted by the Ventilators inspiration flow and time controls.

11.6

PCV/AV - volume ventilation ensured by pressure control

This mode is a variation of the PCV ventilation, and the basic difference between both is the form of inspiration pressure control. In the PCV/AV, the operator adjusts a desired current volume value for deliver to the patient, and the ventilator ensures this volume by switching automatically the inspiration pressure up or down. The following ventilation parameters must be adjusted in PCV/AV (in the sequence in which they are placed in the adjustment mode by the ventilator):

Warning
After starting the ventilation, check whether the respiration parameters indicated in the monitoring region are adequate. If necessary, readjust the ventilator controls.

P (cmH2
O)

AUTOMATIC PRESSURE ADJUSTMENT

PEE P 0
PRESS. TRIGGER

F (l/mi
n)

0
FLO W TRIGGE R

Figure 11.4. PCV/AV Mode. examples of curves: pressure x time and flow x time. Figure 11.4 shows pressure and flow curves in function of time, to assist in the understanding of the PCV/AV mode. The ventilator or the patient can control the start of each respiration, and in this latter case the trigger can be by pressure or flow. At the start of the inspiration the flow reaches its maximum value, then falling until the end of the inspiration time. The pressure is maintained constant during each inspiration, and the ventilator can change the inspiration pressure level automatically between consecutive cycles, to ensure the delivery of the adjusted current volume.

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11.6.1 Initialization sequence - PCV/AV

Cycles 1,2 and 3 Cycle 4 Cycle > 5

PEEP + 5 cmH2O to measure the dynamic complacency. 60% of the pressure necessary to ensure the desired volume. Control of the pressure level to ensure the desired volume.

Note:
The automatic pressure control will reach the adjusted pressure limit.

In case the pressure limit is reached and the volume does not reach the adjusted value, the LIMITED PRESSURE message shows up, meaning that the volume delivered is smaller than the volume that should be ensured. In case the Pressure Limit or Current Volume values are changed, the sequence described above will be restarted.

11.7

SIMV/V - synchronized intermittent mandatory ventilation with volume control

In the SIMV/V ventilation, the patient breathes spontaneously between the ventilator mandatory cycles. The mandatory cycles are volume-controlled, similarly to the VCV mode. The start of each cycle and the respiration frequency are determined by the patient's inspiration effort, which triggers the respirations. In case the patient enters in apnea, or does not succeed in triggering the apparatus due to a very heavy sensibility adjustment, the ventilator enters automatically in the IMV mode (not synchronized) - thus ensuring backup ventilation with the frequency adjusted in the screen. In face of a patient's new stimulus, the ventilation returns automatically to SIMV . The patient can trigger both the mandatory and the spontaneous cycles, which are adjusted in the following manner: Spontaneous cycles - The pressoric support resource can be used, provided the pressoric support pressure control is adjusted to a value above the PEEP. The pressoric support pressure control can be adjusted in OFF to disable this resource. Mandatory Cycles - The SIMV frequency determines the interval for the triggering of each mandatory cycle. The SIMV's frequency is usually adjusted at a low value, allowing the patient to develop several spontaneous cycles between two mandatory consecutive cycles. The operator shall adjust the current volume for the mandatory cycles, and the inspiration pressure limit will work as a safety precaution against barotrauma. The following ventilation parameters must be adjusted in SIMV/V (in the sequence in which they are placed in the adjustment mode by the ventilator):

Warning
After the starting of ventilation, check whether the respiration parameters indicated by the monitoring region are adequate. If necessary, readjust the ventilator controls. In case the ventilation is being limited by the inspiration pressure control limit, the actual vol ume supplied to the patient is smaller than the value adjusted by the ventilator current volume control, and this condition is indicated on the configuration screen by the LIMITED PRESSURE message.

Manual Code: 204010258_002

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P .

(cmH2 O)

T. INS

1/ FREQ T. INS

PEE P 0
PRESS. TRIGGER T. PAUSE

F (l/mi
n)

0 1 2
FLO TRIGGE W R

4
SYNCHRONIS M WINDO W

Figure 11.5. SIMV/V Mode: examples of curves: pressure x time and flow x time. Figure 11.5 shows pressure and flow curves in function of time, to assist in the understanding of the SIMV/V mode. The mandatory cycles operate in a similar way as the VCV mode. The spontaneous cycles can have the pressoric support resource disabled or activated (3). The ventilator or the patient can control the start of each respiration, and in this latter case the patient only can trigger the cycle during the synchronism window time. An inspiration pause can be used in the mandatory cycles (4).

11.8

SIMV/P - synchronized intermittent mandatory ventilation with pressure control

In the SIMV/P ventilation, the patient breathes spontaneously between the mandatory cycles of the ventilator. The mandatory cycles are controlled by pressure in a similar way as the PCV mode. The start of each cycle and the respiration frequency are determined by the patient's inspiration effort that triggers the respirations. In case the patient enters in apnea, or does not succeed in triggering the apparatus due to a very heavy sensibility adjustment, the ventilator enters automatically in the IMV mode (not synchronized) - thus ensuring backup ventilation with the frequency adjusted on the screen. In face of a patient's new stimulus, the ventilation returns automatically to the SIMV . The patient can trigger both the mandatory and the spontaneous cycles, which are adjusted in the following manner: Spontaneous cycles - The pressoric support resource can be used, provided the pressoric support pressure control is adjusted to a value above the PEEP. The pressoric support pressure control can be adjusted in OFF to disable this resource. Mandatory Cycles - The SIMV frequency determines the interval for the triggering of each mandatory cycle. The SIMV's frequency is usually adjusted at a low value, allowing the patient to develop several spontaneous cycles between two mandatory consecutive cycles. The operator shall adjust the inspiration pressure for the mandatory cycles . The following ventilation parameters must be adjusted on SIMV/P (in the sequence in which they are placed in the adjustment mode by the ventilator):

Warning
After starting the ventilation, check whether the respiration parameters indicated by the monitoring region are adequate. If necessary, readjust the ventilator controls.

Manual Code: 204010258_002

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P .
P. LIMIT

(cmH2 O)

T. INS

1/ FREQ P. SUPPORT T. INS

PEE P 0

PRESS. TRIGGER

F ( l/mi
n)

F. PEAK

0 1 2
FLO TRIGGE W R

< 25% F. PEAK

3
SYNCHRONIS WINDO M W

Figure 11.6. SIMV/P Mode: examples of curves: pressure x time and flow x time. Figure 11.6 shows pressure and flow curves in function of time, to assist in the understanding of the SIMV/P mode. The mandatory cycles operate in a similar way as the PCV mode. The spontaneous cycles can have the pressoric support resource disabled or activated (3). The ventilator or the patient can control the start of each respiration, and in this latter case the patient can only trigger the cycle during the synchronism window time.

11.9

BIPV - spontaneous ventilation with two pressure levels

This is a ventilation support mode that maintains a continuous positive pressure (inspiration pressure limit) during part of the cycle, being a relief then performed with the drop of this pressure to a lower level (CPAP). This pressure difference is responsible for the introduction of a certain current volume in the patient, increasing the gaseous exchanges. It is a continuous flow ventilation mode, which allows the patient's spontaneous breathing during both intervals of the ventilation cycle.

Warning
After starting the ventilation, check whether the respiration parameters indicated by the monitoring region are adequate. If necessary, readjust the ventilator controls.

P .

(cmH2 O)

P. MAX. = 50 cm HO

P. LIMIT

P. SUPPORT CPA P

T 2

T 1

PRESS. TRIGGER

T 2

T 1

Figure 11.7 BIPV Mode: example of curve: pressure x time. Figure 11.7 shows the pressure curve in function of time, to assist in the understanding of the BIPV mode. The spontaneous ventilation is processed in two pressure levels. During the T1 time interval the patient breathes on the adjusted pressure limit and during the T2 time interval the patient breathes on the CPAP Pressure. The pressoric support resource can be activated or disabled.

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11.10

CPAP - ventilation with continuous positive pressure in the aerial passages

In the CPAP mode the patient breathes spontaneously on a positive pressure kept constant by the ventilator in the respiration loop. This mode is similar to the BIPV mode, with the difference of having only one pressure level. The following ventilation parameters must be adjusted in CPAP (in the sequence in which they are placed in the adjustment mode by the ventilator):

Warning
After starting the ventilation, check whether the breathing parameters indicated in the monitoring region are adequate. If necessary, readjust the ventilator controls. In case of apnea alarm, arrange for the quick reestablishment of the patients ventilation.

P (cmH2
O) P. LIMIT

2
P. SUPPORT

1
CPA P 0
PRESS. TRIGGER

F (l/mi
n)

F. PEAK

APNEA T.

APNEA ALARM

0
FLO TRIGGE W R

< 25% F. PEAK

Figure 11.8. CPAP Mode: examples of curves: pressure x time and flow x time. Figure 11.8 shows pressure and flow curves in function of time, to assist in understanding of the CPAP mode. The spontaneous ventilation is processed on a pressure level adjusted by CPAP Control. The pressoric support resource can be disabled or activated.

Warning
In CPAP, the PEEP Alarm should be adjusted for the detection of possible disconnections.

11.11

PSV - pressure support ventilation

In the PSV mode the patient inspires initiating a cycle. The pressure is maintained at a constant level during the inspiration (pressoric support), through an automatic system that controls the flow supplied at every moment according to the patient's demand and according to the value adjusted in the pressoric support pressure control. The following ventilation parameters must be adjusted on PSV (in the sequence in which they are placed in the adjustment mode by the ventilator):

Note:
The Inspiration Pressure Limit, Inspiration Time and Breathing Frequency parameters must be adjusted, to allow the adjustment of the backup ventilation (PCV).

Warning
After starting the ventilation, check whether the breathing parameters indicated by the monitoring region are adequa te. If necessary, readjust the ventilator controls.

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P (cmH2
O) P. LIMIT

2
P. SUPPORT

1
CPA P 0
PRESS. TRIGGER

F (l/mi
n)

F. PEAK

APNEA T.

APNEA ALARM

0
FLO TRIGGE W R

< 25% F. PEAK

Figure 11.9. PSV Mode: examples of curves: pressure x time and flow x time. Figure 11.9 shows pressure and flow curves in function of time, to assist in the understanding of the PSV mode. The pressoric support resource maintains the pressure at a constant level during the inspiration. If the patient stops breathing for a time longer than the apnea time, the ventilator starts automatically to send PCV Cycles.

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12

SPECIAL FUNCTIONS

The CARMEL Servoventilator is equipped with some special functions that are useful in certain clinical situations. Such functions are described below .

12.1

Inspiration Pause and Expiration Pause

The inspiration pause is a function that interrupts the flow, during this phase, during 6 seconds. To activate this function, press the INSP/EXP button (6) during the inspiration phase and the lower part of the screen will display the MANUAL INSPIRATION PAUSE massage. It can be used, for example, for the determination of the Plateau pressure. The expiration pause also interrupts the flow, however, in the expiration phase it has a 4-second duration. To activate this function, press the INSP/EXP button (6) during the expiration phase and the lower part of the screen will display the EXP. MANUAL-AUTO PEEP: xx cmH2 O message.

12.2

Auto-PEEP Measurement

It can be used, for example, to check whether the expiration time is enough for the patient to expire. To use this function, press the INSP/EXP button (6) during the expiration phase and the lower part of the screen will display the EXP. MANUAL-AUTO PEEP: xx cmH2O message.

Note:
The auto-PEEP value shown corresponds to the measured value plus the PEEP adjusted in the ventilator. Example: if the PEEP is adjusted to 5 cmH2O and the measured auto-PEEP is 10cmH2O, then the total pressure at the end of the expiration will be 10 cmH2O.

12.3

100% of Oxygen

When pressing the fast access 100% O2 key (7) the ventilator activates this function, sending a concentration of 100% of oxygen for 90 seconds; which can be cancelled at any time by pressing the same key again. If the function is not cancelled at the end of this time, the oxygen concentration returns to the previously adjusted value.

12.4

Relief

Supplies automatically an inspiration time 50% above the one adjusted at each number of cycles. This resource is activated or disabled through the control monitor configuration screen.

12.5

Measurement of the Tobin Index (iT)

Performs the measurement of the Tobin Index, which is the ratio between the spontaneous ventilation frequency (breathing/min) and the current volume in liters. This index proved to be a good predictor of the success of the disconnection of many patients needing mechanical ventilation. A Tobin's Index (iT) <105 breathings/min/l can be an accurate and precocious predictor of the disconnection results. For this measurement the patient should be in the CPAP mode without pressoric support (totally spontaneous). This parameter is calculated automatically by the equipment and is displayed in the monitoring screen.

12.6

Measurement of the P0.1 Occlusion Pressure of the Aerial Passages

Performs the P0.1 measurement, which is the inspiration pressure measured 100 milliseconds after the occlusion of the aerial passages. The P0.1 is independent of the effort and is well correlated with the central breathing impulse. The patients dependent on the ventilator and that present a P0.1 of > 6cmH 2O are usually difficult to get disconnected. In case a PEEP Value is being used, this value will be the base line for the P0.1 measurement. For this measurement it is necessary for the patient be in the SIMV/P mode. This parameter is calculated automatically by the equipment and is shown in the monitoring screen in the P x t curve.

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13

CLEANING AND STERILIZATION

Warning
Disconnect the CARMEL Servoventilator before cleaning it. Do not immerse the ventilator in any liquid.

The procedure of cleaning, disinfecting and sterilizing the parts in touch with the patient must be performed before the first utilization and in the subsequent reutilizations. 1. To clean the external parts of the ventilator use a clean and soft cloth, humidified in water and soap (detergent). Be

careful to avoid the accumulation of cleaning products in the apparatus connections. After cleaning, rinse and dry with a clean, dry and soft cloth. 2. To clean the ventilator screen use a clean and soft cloth without shreds. Do not use paper towels or rough cloths, to avoid

scratching the screen surface. 3. 4. Do not use abrasive or corrosive agents while cleaning. The respiration loop components, if not used with bacterial filter, should be disassembled after each patient for

disinfection or sterilization, including: corrugated tubes (of plastic or silicone), heated humidifier chamber (item 5.7), drain tubes (item 5.9), nebulizer (item 5.10), expiration valve (item 5.8), expiration valve diaphragm, flow sensor (item 6.4), flow sensor and intermediary tubes. Use glutaraldehyde, hydrogen peroxide or ethylene oxide. The plastic corrugated tubes, nebulizer and the intermediary and the white cover of the flow sensor can be submitted to thermo-disinfection, however only in sensitive cycles (chemical thermo-disinfection), in other words, they support low temperatures, of at most 60C. The remainder can be sterilized in autoclave, up to a maximum temperature of 136C. If the respiration loop components are used with bacterial filter, establish a daily routine (once a day) for disinfecting or sterilizing them. The ventilators loop components that are used in ICUs, should obligatorily be reprocessed after each patient, with utilization of filter or not. 5. The silicone parts (tubes and tracheas) have the intrinsic characteristics of the silicone of no deformation (up to 150 C,

and an undetermined service life time), at ambient temperature, maintaining the silicone application and properties; it is recommended to store them in a clean and organized place free from perforating materials or contaminants, preferably following the cleaning and organization instructions the good manufacturing practices (GMP), not exposing them to the sun and avoiding temperatures above 40 or locations close to equipment subject to heating (like ovens and sterilizers).

Note
The maximum life cycle recommended for tracheas/tubes should be up to 50 sterilizations, in steam sterilization processes (autoclaving) with 20-minute cycles and with 1bar/15PSI and 121C/250F, after starting to use them.

Warning
Perform a visual and functional inspection of the components after the cleaning / sterilization procedure, in order to detect signs of wear. Desiccated tubes and/or tubes with fissures and irregular fitting indicate the need of replacement of these components. Special attention should be given to the flow sensor cleaning, because, the accumulation of liquid substances can interfere in the values measured and displayed by the ventilation monitor. Therefore, the doctor shall specify a cleaning periodicity according to patient's state or at least every 2 hours. When using ethylene oxide, it is necessary to follow the instructions supplied by the manufacturer of the sterilization equipment, to determine the temperatures and times of the indicated aeration.

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RECOMMENDATIONS FOR THE PROCESSING OF THE K. TAKAOKA ANESTHESIA AND MECHANICAL VENTILATION EQUIPMENT COMPONENTS.
Hospital equipment used in gaseous anesthesia and mechanical ventilation is classified as being semi -critical , due to their potential risk to transmit infections. Semi-critical items are all those that enter in touch with healthy mucosa and/or injured skin and usually dont penetrate in the sterile cavities of the body, thus are able to prevent the invasion of the sub-epithelial tissues that require high level of disinfection or sterilization, in order to ensure their multiple use quality. The choice of the processing, disinfection or sterilization method depends on nature of the materials. The CHART shows the methods recommended for the processing of the anesthesia and mechanical ventilation equipment belonging to the K. TAKAOKA product line, considering their composition and technical specifications. The recommended methods are: cleaning, chemical and thermal disinfection and chemical, gaseous or plasma sterilization. The processing should be performed following a sequence of steps, illustrated in the FLOW-CHART below . CONCEPTS OF: CLEANING A process that removes dirt and organic matter from any surface or object. Cleaning is usually performed through mechanical friction, immersion, cleaning machines and ultra-sound machines. It is the most important stage of decontamination; all items shall be washed before submitted to any disinfection or sterilization process. No object should be sterilized if there is organic matter over it (oil, fat, blood...). The cleaning should be made alw ays with water and soap, when the immersion method is used, using preferentially enzymatic detergents. The later have specific activity on organic matter, degrading it and dissolving it in a few minutes. The objects should be immersed for 5 minutes. DISINFECTION A thermal or chemical process that eliminates all microorganisms, except the sporulated. Disinfection is classified in three categories: high, medium and low level. HIGH LEVEL DISINFECTION A process that eliminates all microorganisms except a large number of spores (bacteria, almost all fungus spores, TB bacillus and viruses) with a time of exposure between 10 and 30 minutes. Example: Immersion in Glutaraldehyde INTERMEDIATE LEVEL DISINFECTION A process that turns inactive vegetative bacteria, fungus and almost all viruses, except spores. Example: Mechanical friction with alcohol at 70%. LOW LEVEL DISINFECTION A Process that turns inactive most bacteria, some fungus and some viruses, but do not affect more resistant microorganisms as TB bacillus and spores. Used only for surfaces. Example: Water and detergent cleaning. THERMAL DISINFECTION A thermal process that uses thermal-disinfectant liquids against all vegetative forms, destroying part of the spores when used at a temperature between 60 and 90C. This process is performed in a thermal disinfection unit that works with two kinds of cycles, for sensitive and resistant materials, with the utilization of appropriate detergents . STERILIZATION A process that completely eliminates all microorganisms (spores, bacteria, fungus and protozoan), and is accomplished by physical (steam) or chemical (liquid-gluteraldehyde, gaseous - ethylene oxide and plasma-hydrogen peroxide) processes. The spore is the most difficult form of microorganism to become inactive. Example: Autoclave, Hydrogen peroxide, ethylene oxide, gluteraldehyde (exposure of the material 10 hours).

Note:
Hydrogen peroxide (oxygenated water) is a sterilization process that occurs at a maximum temperature of 45C. Materials that cannot be autoclaved can be sterilized with peroxide, except materials derived from cellulose.

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FLOWCHART
Flowchart of the sequential steps of the processing of Anesthesia and Mechanical Ventilation Equipment components

WITH PRESENCE OF ORGANIC MATTER OR DIRT

CONSIDER ALL CONTAMINATED

CLEAN

HUMID CLOTH

DETERGENT SOLUTION

RINSE

DRY

ACCORDING TO ARTICLE DESTINATION

IF STERILIZATION

IF PROCESSING ENDED

IF DISINFECTION

PHYSICAL MEANS (STEAM)

CHEMICAL MEANS

PACK

LIQUID CHEMICAL ME ANS ALCOHOL 70%

LIQUID PHYSICAL MEANS THERMODISINFECTION

LIQUID CHEMICAL MEANS (GLUTARALDEHYDE)

PACK

LIQUID (GLUTARALDEHYDE)

GASEOUS (ETHYLENE OXIDE)

PLASMA (HYDROGEN PEROXIDE)

MECHANICAL FRICTION

IMMERSE FOR ADEQUATE TIME AND TEMPERATURE

IMMERSE THE ARTICLE

STERILIZE

IMMERSE TOTALLY

PACK

PACK

PACK

DRY ASEPTICALLY

FILL PIPING

STORE

FILL PIPING

STERILIZE

STERILIZE

STORE

PACK

ENXAGAR COM H2O ESTERILIZADA

RINSE WITH STERILIZED H2O

STORE

STORE

STORE

DRY ASEPTICALLY

DRY ASEPTICALLY

PACK

PACK IN STERILIZED FLASK

STORE

STORE

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TABLE

Recommended methods for the processing of the TAKAOKA Anesthesia and Mechanical Ventilation Equipment components.

Component

Cleaning

Disinfection

Sterilization

Esphigmomanometer clamp Anti-pollution Balloon

Detergent solution Detergent solution

NOT RECOMMENDED glutaraldehyde Thermodisinfection Sensitive Alcohol at 70% Synthetic phenol Synthetic phenol Synthetic phenol Glutaraldehyde Thermodisinfection resistant Glutaraldehyde Thermodisinfection Sensitive Glutaraldehyde Thermodisinfection Sensitive NOT RECOMMENDED Glutaraldehyde Alcohol at 70% Glutaraldehyde Alcohol at 70% Glutaraldehyde Thermodisinfection resistant Alcohol at 70% Synthetic phenol Glutaraldehyde Thermodisinfection resistant Glutaraldehyde Alcohol at 70% Glutaraldehyde Thermodisinfection sensitive Glutaraldehyde Thermodisinfection sensitive

NOT RECOMMENDED Ethylene oxide, Glutaraldehyde or Hydrogen peroxide NOT RECOMMENDED

Flowmeter Blocks

Humid cloth

Esphigmomanometer cable ECG Cable / Oxymeter

Detergent solution Detergent solution

NOT RECOMMENDED NOT RECOMMENDED

Humidifier Chamber

Detergent solution

Steam Ethylene oxide, Glutaraldehyde or Hydrogen peroxide Ethylene oxide, Glutaraldehyde or Hydrogen peroxide NOT RECOMMENDED Ethylene oxide or Glutaraldehyde Ethylene oxide or Glutaraldehyde Steam Hydrogen peroxide NOT RECOMMENDED Steam or Glutaraldehyde Hydrogen peroxide Steam or Glutaraldehyde Ethylene oxide, Glutaraldehyde or Hydrogen peroxide Ethylene oxide, Glutaraldehyde or Hydrogen peroxide

Bell Canister

Detergent solution Detergent solution

Galvanic cell for Oxymeter *

Detergent solution

Stem Assembly for Bell Elbow of Air Leak

Detergent solution Detergent solution

Drainage tubes

Detergent solution

Flowmeter Bellows

Humid cloth Detergent solution

Aspiration flask Intermediary in Y (mouthpiece)

Detergent solution Detergent solution

Intermediary T of Capnograph

Detergent solution

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Component

Cleaning

Disinfection Glutaraldehyde Alcohol at 70% Synthetic phenol Alcohol at 70% Synthetic phenol Alcohol at 70% Synthetic phenol Alcohol at 70% Glutaraldehyde Glutaraldehyde Thermodesinfection resistant Synthetic phenol Alcohol at 70% Alcohol at 70% Glutaraldehyde

Sterilization Ethylene oxide or Glutaraldehyde NOT RECOMMENDED

Mask Monitor Module

Detergent solution Humid cloth

Ventilator Module Furniture (external parts)

Alcohol at 70% Alcohol at 70%

NOT RECOMMENDED NOT RECOMMENDED Ethylene oxide, Glutaraldehyde or Hydrogen peroxide Steam Ethylene oxide Hydrogen peroxide Ethylene oxide Hydrogen peroxide Ethylene oxide Hydrogen peroxide Ethylene oxide Hydrogen peroxide Ethylene oxide or Glutaraldehyde Ethylene oxide or Glutaraldehyde NOT RECOMMENDED Ethylene oxide, Glutaraldehyde or Hydrogen peroxide NOT RECOMMENDED

Mask clip

Detergent Solution

Flow sensor Axillary Temperature Sensor

Detergent Solution Detergent Solution

Injected Liquid Temperature Sensor Esophagic Temperature sensor

Detergent Solution Detergent Solution

Side Stream (Capnograph)

Detergent Solution

Glutaraldehyde Glutaraldehyde Alcohol at 70% Glutaraldehyde Thermodesinfection sensitive Glutaraldehyde Alcohol at 70% Glutaraldehyde Thermodesinfection sensitive Synthetic phenol Alcohol at 70% Synthetic phenol Alcohol at 70%

Support of the Canister Corrugated Tubes **

Detergent Solution Detergent Solution

Vacuum Gage Inspiration and Expiration Valves

Detergent Solution Detergent Solution

Calibrated Vaporizer

Humid cloth

Multiagent Vaporizer

Humid cloth

NOT RECOMMENDED

Note:
* Galvanic cells for FiO 2 measurement should be cleaned with a cloth humidified in water and soap, they should not be immersed in solution. ** Siliconized corrugated tubes can be autoclaved and submitted to resistant thermodisinfection.

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14
1.

MAINTENANCE
At least once a month, check whether the tubes, sensors, cables and other CARMEL Components are not damaged,

worn out or with fissures. In case of any damage, arrange for the component replacement. Do not use damaged components . 2. 3. The expiration valve diaphragm should be carefully inspected for integrity at least once a month (item 5.8). The expiration valve diaphragm should be replaced at least every 6 (six) months, and whenever necessary (item 5.8).

Note:
The expiration valve block fastening to the ventilators Front Connection Panel should be performed firmly, to avoid gas leaks. Check periodically the perfect status of the sealing ring (O-ring), as pointed out in the item 5.8.

4. 5.

The flow sensor tubes should be replaced at least every 2 (two) months, and whenever necessary. Check periodically the perfect preservation status of the Heated Humidifier cover rubber gasket, to ensure a perfect

sealing in the closing of the chamber. If necessary, replace this gasket by a new one. 6. Check the conditions and replace periodically the corrugated tubes of the respiration loop, because they constitute normal

wear components. 7. . 8. . 9. . 10. If the maximum inspiration pressure does not reach the expected value, check initially: if there are no leaks in the respiration loop; if there are no leaks in the humidifier cover; if all connections are tight; if the pressure c ontrol is not adjusted too low; if the current volume control is not adjusted too low; if the O2 and compressed air network pressures are not too low; if the expiration valve set is correctly assembled, with clean diaphragm and in perfect conditions; if the inspiration flow control is not adjusted too low. If the current volume does not reach the expected value, check initially; if there are no leaks in the respiration loop; if there are no leaks in the humidifier cover; if all the connections are tight; if the pressure control is not adjusted too low; if the O2 and compressed air network pressures are not too low; if the expiration valve set is correctly assembled, with clean diaphragm and in perfect conditions; if the inspiration flow control is not adjusted too low. If the CARMEL cannot be successfully powered from the electric network, check initially: if there is voltage in the 110 to 220 Vac electric network outlet; if the CARMEL fuse is not blown out. The compressed air and oxygen filter should be opened and cleaned twice to three times a year, depending on the

utilization degree of the ventilator and of the purity of the medical gases. The draining of the filter condensate is automatic. 11. 12. Use only sensors, cables and tubes specified by K. TAKAOKA for the equipment. Do not use the CARMEL in case the self-test indicates any irregularity. Provide a solution for the problem presented,

through an authorized K. TAKAOKA dealer. 13. The ventilator should be submitted to an annual inspection by a K. TAKAOKA authorized technician, for recalibration.

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14.1

Internal Rechargeable Battery

v Whenever possible keep the internal battery with its maximum charge, to increase service life. Constant discharging of the battery decreases the service life. v The internal battery is sealed and maintenance-free. In case it shows any operation problem, contact the authorized Technical Assistance. v Check whether there is power in the electric network outlet, if the battery does not charge as usual.

14.2

Fuse Replacement 14.2.1 Fuse replacement instructions (built-in in the outlet)

Disconnect the ventilator from the electric network; Remove the cable of the ventilator outlet; The fuse holder is located in the bottom of the outlet. Press from top to bottom the lock at the center of the fuse holder and pull to remove it; Replace the fuses according to the their technical specification; Mount back the fuse holder to the outlet, pushing until it locks; Reconnect the cable to the ventilator outlet.

14.2.2 Fuse replacement instructions (individual)

Place a screwdriver in the fuse holder slot; Rotate it counterclockwise as far as possible (do not force) to unlock the fuse holder; Pull the fuse holder; Replace the fuses according to the their technical specification; Push the fuse holder; Rotate it clockwise as far as possible (do not force) to lock the fuse holder; Reconnect the cable to the ventilator outlet.

Warning
Use only K. TAKAOKA original spare parts. The use of non-original parts can place in risk the patient's safety. Do not perform any internal service in the CARMEL and do not open its housing. To perform any internal maintenance or for a periodic overhaul, contact the authorized Technical Assistance.

Note
Additional documentation for the performance of preventive/corrective maintenance will be supplied under mutual agreement.

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15
15.1

TROUBLESHOOTING
Message in the Monitor
PROBABLE CAUSE CORRECTIVE ACTION Tighten all connections firmly and always check for fissures in the trachea

MESSAGE IN THE MONITOR

Leak in the respiration loop.

Opening in the humidifier chambercover DISCONNECTION Opening in the sensor temperature connection located in the intermediate Y piece. Inappropriate controls such as, low maximum pressure ( 8 cmH2 O), low inspiration flow and breathing frequency. Folding or obstruction of the expiration branch. Expiration valve diaphragm is not mounted correctly. EXP. OBSTRUCTION Expiration valve diaphragm is damaged. Expiration valve diaphragm with secretions. Flow sensor with secretions. Secretions or water in the tracheae.

Check whether the sealing rubber is correctly positioned, the humidifier cover is perfectly closed (clockwise threading) and the tracheae are firmly connected to the cover.

Cover the temperature sensor connection with the appropriate cover, or if desired connect the temperature sensor from the humidifier

Perform the appropriate controls according to the patient's weight and physical conditions.

Undo the folding or the obstruction of the expiration branch. Mount correctly the diaphragm. Replace the diaphragm. Clean or replace the diaphragm. Clean or replace the flow sensor. Clean or replace the tracheae. Clean or replace the flow sensor and its line. To dry the flow sensor line use O2 and never inject O2 in the line when it is connected to the equipment. Readjust the alarm limits according to the patient. Inform the person responsible for gas supply and request the necessary correction. Adjust the regulator valve at 35 PSI (241 kPa). Remove the regulator valve of the wall, because, it is not necessary. Inform the person responsible for gas supply and request the necessary correction. Adjust the regulator valve at 35 PSI (241 kPa) Remove the regulator valve from the wall, because it is not necessary.

PRESSURE HIGH

Secretions or water in the flow sensor or in its line. Inappropriate adjustment of the alarms limits. Air network pressure below the specified 40 PSI (280 kPa).

CHECK AIR SYSTEM

Air regulator valve badly adjusted. Regulator valve in the wall. O2 system pressure below the specified 40 PSI (280 kPa).

CHECK O2 SYSTEM

O2 regulator valve badly adjusted. Regulator valve on the wall.

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Electric network failure ELECTRIC NETWORK DOWN

The ventilator will automatically switch to the internal battery; this battery will not supply the humidifier. Inform the person responsible for the electric network and request the necessary correction. Connect the electric network cable correctly to a 110 or 220 VAC, 50/60Hz, properly grounded outlet. Check the fuse and replace if necessary, by another with the same specifications. Readjust the alarm limits according to the patient.

Accidental disconnection of the power source cable. Blown out fuse. Inappropriate adjustment of the alarms limits.

PEEP LOW

Leaks

Check the conditions and the correct assembly of all the respiration loop components, of the expiration valve and of the heated humidifier. See also DISCONNECTION and EXP. OBSTRUCTION

Basic flow low

Adjust the basic flow to keep the PEEP and then check for leaks in the respiration loop.

Secretions or water in the flow sensor or in its line.

Clean or replace the flow sensor and its line. To dry the flow sensor line use O2 and never inject O2 in the line when it is connected to the equipment.

CHECK LINE AND SENSOR

Flow sensor or line connectors broken or worn out.

Replace the flow sensor or its line. Check whether the larger connector is connected to the blue line and whether the smaller connector is connected to the transparent line, this should be the correct position. Observe the color coding to position the lines correctly in the equipment. Replace the line. See CHECK AIR AND O2 NETWORK See ELECTRIC NETWORK DOWN Call the authorized technical assistance. Evaluate the cause of the pressure limitation: High resistance in the respiration loop due to excessive water and/or secretions; Current volume adjusted higher than needed by the patient's conditions.

Line connectors inverted in the sensor or in the equipment.

Lines torn out when separated Gas supply. SELF-TEST FAILS Electric supply. Internal operation. In the VCV, SIMV/ and PCV/AV modes, the ventilation could be limited by the inspiration pressure control limit, therefore, the supplied current volume will be smaller than the adjusted value.

LIMITED PRESSURE

15.2

Occurrences
OCCURRENCE DIFFERENCES PROBABLE CAUSE Relocation of the F x t curve base line to a position different from zero. Leaks. CORRECTIVE ACTION Turn Off and then Turn On the equipment. Check the conditions and the correct assembly of all the respiration loop components, of the expiration valve and of the heated humidifier. See also DISCONNECTION and EXP. OBSTRUCTION

BETWEEN INSPIRED AND EXPIRED VOLUMES

Warning
If after the corrective action the problem persist, contact K. TAKAOKA authorized technical assistance.

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16

MEASUREMENT METHODS

Warning
All the calculations are based on distal flow and pressure measurements. The times are obtained from the flow curves, the volumes from the integral of the flow, the pressures from the pressure curve and complacencies, resistance and work from the pressure and flow set.

16.1

Volumes
ti

Volumeinsp = Flowexp dt
0

where ti is the inspiration time

Volumeexp = Flowexp dt
0

te

where te is the expiration time

Volumeinsp_average =

Volume [n]
n=1 insp

Volumeminute = Volumeexp Frequencyaverage

16.2 Frequency

Frequencyaverage =

Frequency[n]
n=1

Is obtained from the measurement of time elapsed between two inspiration cycles.

16.3

I:E Ratio

I : E =1

ti te

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16.4

Inspiration and Expiration Time

Timeins_average =

Time [n]
n=1 ins

Timeexp_averag e =
16.5

Time [n]
n=1 exp

Maximum, Medium, Plateau and PEEP Pressure

Pressuremx ? During the inspiration cycle the highest value of the read pressure is sought for. Pressureplat ? During the inspiration cycle and after obtaining the highest pressure value, a pressure stability at a value below Pmax and which lasts more than 100 milliseconds is sought for. PEEP is measured during the expiration cycle, by searching the point where the flow is smaller than 3 lpm and where a temporary stability higher than 200 milliseconds exists .

Pressure average =

Pressure[n]
n =1

Measured from the beginning of the inspiration cycle (n=1) up to the beginning of the next inspiration cycle (N). 16.6 Resistance

The Jonson's Method is used, where:

P. end of INSP

Resistance =

Pressureend _ of _ inspiration Flowexpiration_maximum

maximum

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16.7

Complacency

Complacencystatic =

Volumeexp Pressureplateau PEEP

Volumeexp Pressuremax imum PEEP

Complacencydynamic =
Note:

In the alphanumeric window, the value of the static complacency is shown, however, according to the previously described plateau pressure measurement method, the static complacency can be equal to the maximum pressure and, in this case, the value shown is the dynamic complacency.

Static complacency

Dynamic complacency

16.8

Inspiration work
vf

Workinsp = Pressure_ dV
vi

where

vi is the initial volume and vf is the final volume

Warning
Excessive noise in the flow measurement line can affect the volume calculations. The Ventilator compensates automatically thermal deviations that result 5 lpm, above this value turn the ventilator off and then on again.

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17

SYMBOLOGY

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18

EMERGENCY ACTIONS

In case of an adverse event K. TAKAOKA sugges ts the following procedure:

v Contact the manufacturer (Technical Assistance) about the situation of the apparatus and do not perform any test or
investigation without the presence of a K. TAKAOKA authorized technician.

v Register the manufacturer, model and serial number of all the equipment involved in the adverse event. Enter this information
in the patient's record and/or in an uncommon occurrence form. If the equipment is disposable or is provided with disposable components, enter also the classification number and all the numbers of all disposable items. It is important to keep the equipment and any component involved in the adverse event.

v Do not clean or submit to a chemical or physical process, or repair the equipment. These actions may affect its performance
and its safe use.

v Enter the names of all the health professionals present in the incident. v Identify the equipment, pointing out that it was involved in an adverse event, the event's date, and the name of the person who
labeled the equipment. n I form in the label that the equipment should not be used, cleaned, repaired, or destroyed without approval of an authority, such as the risk manager. If the adverse event involves more than one piece of equipment, all the equipment involved should be labeled and preserved.

v Preserve the packaging of all the disposable components involved in the event and keep them together with the equipment.
The packaging of the disposable items typically includes not only a registered equipment number, but also the lot number. Additionally, some specifications included in the packaging can be useful for the inspectors.

v Before disconnecting the equipment from the electric power or remove the batteries, check whether the memory in the
equipment will not be lost. Much equipment has computerized memory that can be lost if the batteries are removed or if the device is disconnected from the electric network. Experts can use this memory to determine specifically when the events of the listed equipment occurred. In order to determine which devices have computerized memory and how they could be controlled after an event, read the instructions manual or contact your clinical engineer.

v Place the equipment and its components in a safe location to prevent subsequent damages. This will prevent the equipment
from being placed back in service; rooms protected and equipment may need to be used despite a previous incident.

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19

WARRANTY TERM

K TAKAOKA IND. E COM. LTDA. warrants the equipment it produces against manufacturing defects for a period of one year as of the date of acquisition by the first owner. Please find below the list of the K TAKAOKA IND. E COM. LTDA. authorized technical assistance facilities in the national territory and abroad; which, besides the factory, hold exclusive maintenance rights. The modification, violation, adjustment or maintenance carried out by third parties is not authorized. The equipment manufactured or repaired by K TAKAOKA IND. E COM. LTDA. receive a warranty seal. The warranty will be automatically voided if the seal is found violated. The inadequate use and/or the use of the equipment not in accordance with as instructions contained in this manual, the use of a voltage different than the one specified and of parts and/or components not homologated by K TAKAOKA IND. E COM. LTDA. will void the warranty. Damages caused by accidents or natural agents are not included in the warranty, as well as batteries, fuses, filters, etc... The items supplied together with the equipment, as well as some optional items and their respective warranty periods against manufacturing defects are listed below. CODE 201050035 202010523 446010053 202010612 202011182 202012068 202010614 202011665 203060031 203100149 204010258 202011152 202011669 202011670 202011671 201050003 202011938 203100150 202011153 202012085 CARMEL Servoventilator Movable base 15 LCD Monitor Pivoted arm 3m extension for O2 Extension for compressed air Compressed air filter Flow sensor tube 400 mm Luer Lock Lid Adult Flow Sensor Operation Manual Respiration valve diaphragm Adult respiration loop silicone Infantile respiration loop silicone (optional) Newborn respiration loop silicone (optional) Heated Humidifier 6060 w/ chamber O2 Filter (optional) Infantile Flow Sensor (optional) Expiration valve block (extra) (optional) Cell for O2 measurement with intermediate piece and cable description Warranty 1 year 1 year 1 year 1 year 6 months 6 months 6 months 3 months 3 months 6 months Not Applicable 3 months 3 months 3 months 3 months 1 year 6 months 6 months 6 months 6 months

The service life of the CARMEL Servoventilator is estimated as an average of 5 years, which may vary according to the use conditions and adequate preventive maintenance.

Responsible Technician: Mauricio Chiarioni CREA n. 5061714921

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K. TAKAOKA DISTRIBUTORS IN THE NATIONAL TERRITORY

ALAGOAS CASA DO MDICO R. Roberto Simonsen, 412 Cep: 57052-675 Tel/Fax: (82) 338-8777 Cel: (82) 9381-2526 E-mail: compras_cmedico@hotmail.com MACEI / AL - Rogrio AMAP / PAR MEDICINAL Com. e Repres. Ltda Av. Cipriano Santos, 580 Cep: 66070-000 Tel/Fax: (91) 266-0203 Cel: (91) 9981-8137 E-mail: medcinal@amazon.com.br BELM / PA - Arlindo AMAZONAS / RONDNIA DANI Com. Repres. Prest. Services Ltda R. 10 of Julho, 489A Cep: 69010-060 Tel: (92) 622-2700 / 622-2701 Fax: (92) 233-3093 Cel: (92) 9146-0305 (Nelson) / (92) 9146-0304 (Andr) E-mail: dani.compras@horizon.com.br MANAUS / AM - Nelson BAHIA ODONTOBIOMED Commercial Ltda Av. Anita Garibalde, 1815 Ed. CME Lj. 11 Bl. A Ondina Cep: 40170-130 Tel: (71) 245-6547 Fax: (71) 237-0384 / 235-9390 Cel: (71) 8814-1920 / 9143-6547 / 9983-5683 E-mail: odontobiomed@uol.com.br SALVADOR / BA - Keller CEAR HOSP TRADE do Brasil Rua Dom Lino, 672 A Parquelndia Cep: 60450-280 Tel: (85) 281-7400 / Fax: 223-5262 E-mail: commercial@hosptrade.com.br FORTALEZA / CE Paulo Marcelo Gomes DISTRITO FEDERAL CTI Com. Repres. Assist. Tcnica Ltda SHN, Qd. 02 Bl. E Ed. Kubitscheck Plaza Sl. 69 Sobreloja 79 Cep: 70710-908 Tel/Fax: (61) 327-6166 / 327-5483 / 329-3583 Cel: (61) 9981-0040 (Marco) / (61) 9983-2830 (Gilvan) E-mail: cti.com@uol.com.br BRASLIA / DF - Marco and Gilvan ESPRITO SANTO MEDSHOP Comrcio Products Mdicos Ltda R. Leoni Souza Guedes, 12 - Ilha Monte Belo Cep: 29040-550 Tel: (27) 3222-2666 Fax: (27) 3222-3413 Cel: (27) 9982-2666 (Paulo) / (27) 9989-6372 (Rinaldo) E-mail: medshop@veloxmail.com.br VITRIA / ES - Paulo Bastos / Rinaldo / Alex GOIS MS Equipment Hospitalares Ltda Av. Areio, 595 Setor Pedro Ludovico Cep: 74820-370 Tel/Fax: (62) 281-1177 Cel: (62) 9972-2187 E-mail: mseh@terra.com.br GOINIA / GO - Divino MARANHO HOSPFARMA Repr. Com. of Mat. Hospitalar Ltda Av. dos Holandeses QD 37 Lote II - Calhau Cep: 65071-380 Tel/Fax: (98) 227-5345 / 5392 E-mail: medsurgery@elo.com.br ARE LUIS / MA Alex Lima MATO GROSSO MEDLAB Com. Equip. Mdico-Hospitalares Av. So Sebastio, 1603 Cep: 78020-510 Tel/Fax: (65) 624-3824 Cel: (65) 9982-6263 (Anselmo) / (65) 9981-7407 (Holanda) E-mail: medlabmt@terra.com.br CUIAB / MT - Anselmo / Holanda MATO GROSSO DO SUL CENTRO AMRICA Mat. Mdicos e Hospitalares Ltda R. Rui Barbosa, 3845 Cep: 79002-363 Tel / Fax: (67) 324-1212 / 324-9413 / 324-5003 Cel: (67) 9983-1982 E-mail: camerica@brturbo.com CAMPO GRANDE / MS Mauro Boer / Moacir

MINAS GERAIS ARS Eletromedicina Ltda (Juiz of Fora) R. Monsenhor Gustavo Freire, 114 Cep: 36016-470 Tel/Fax: (32) 3216-6617 Cel: (32) 9987-4062 (Gilson) E-mail: arsvend@uai.com.br JUIZ OF FORA / MG Gilson BELMED Eletromedicina Ltda (BH and Grande BH) R. Alvares Maciel, 337 Cep: 30150-250 Tel: (31) 3241-1913 / Fax: (31) 3241-2723 Cel: 31 9974 8373 (Carlos) / (31) 9981-1913 (Delio) E-mail: belmed@belmed.com.br BELO HORIZONTE / MG - Carlos / Dlio / Adriana ANESTEMINAS Ltda (North and South) Av: Cel Alfredo Custdio of Paula, 193 Cep: 37550-000 Tel: (35) 3422-8532 / Fax: (35) 3425-6309 Cel: (35) 9191-9000 (Luiz Carlos) (11) 9939-3683 (Carlos) E-mail: anesteminas@anesteminas.com.br POUSO ALEGRE / MG - Luiz Carlos CIRRGICA VILA Ltda (Tringulo Mineiro) R. Pde. Euclides, 671 Campos Elseos Cep: 14080-200 Tel/Fax: (16) 636-5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos PARABA / PERNAMBUCO / RIO GRANDE DO NORTE ANESTENORTE Com. Repres. Ltda R. Costa Gomes, 163 Madalena Cep: 50710-510 Tel: (81) 3228-1722 Fax: (81) 3228-4261 Cel: (81) 9111-0764 (Hlio) / (81) 9172-1200 (Gilberto) E-mail: anestenorte@uol.com.br RECIFE / PE - Hlio Lucena / Gilberto PARAN MEDITCNICA Repres. Equip. Hosp. Ltda R. Chile, 1107 Rebouas Cep: 80220-180 Tel: (41) 332-6364 Fax: (41) 332-8766 Cel: (41) 9972-3881 (Lcio) / (41) 9975-1336 (Lori) E-mail: meditecnica@terra.com.br CURITIBA / PR - Lcio / Lori PIAU REMAC Odontomdica Hospitalar Ltda R. Barroso, 1.009 Centro Cep: 64000-130 Tel: (86) 221-3011 Fax: (86) 221-2280 Cel: (86) 9981-1108 (Srgio) / (86) 9432-4406 (Ana) E-mail: remacvendas.takaoka@veloxmail.com.br TERESINA / PI Srgio / Ana Valeska RIO OF JANEIRO RIO TAK Com. e Repres. Mat. Cirrg. Ltda R. Sacadura Cabral, 81 Grupo 701 Cep: 20081-260 Tel: (21) 2263-9602 Fax: (21) 2253-3458 Cel: (21) 7837-8864 (Roberto) / (21) 9985-0787 (Marcos) E-mail: riotak@terra.com.br RIO OF JANEIRO / RJ Roberto / Marcos / Felipe PB HOSPITALAR R. Dr. Borman, 23 Grupo 801 Niteri Cep: 24020-320 Tel/Fax: (21) 2719-6611 / 2620-4377 / 2719-6611 Cel: (21) 9995-1727 (Wagner) / (21) 9197-6141 (Padilha) E-mail: pbhospitalar@urbi.com.br RIO OF JANEIRO / RJ Wagner RIO GRANDE DO SUL HOSPITRADE Ltda R. So Manoel, 1994 Santana Cep: 90620-110 Tel/Fax: (51) 3217-6771 / 3223-1436 / 3223-0460 Cel: (51) 9956-0510 (Carlos) / (51) 9961-4506 (Artur) E-mail: htrade@hospitrade.com.br PORTO ALEGRE / RS Carlos / Artur SANTA CATARINA HOSPITLIA Cirrgica Catarinense Ltda R. Prof. Custdio of Campos, 281 Cep: 88090-720 Tel: (48) 241-1100 / 241-5567 / Fax: (48) 241-5585 Cel: (48) 9982-1608 (Elson) / (48) 9981-2602 (Carlos) E-mail:hospitalia.cirurgica@terra.com.br FLORIANPOLIS / SC - Elson / Carlos SERGIPE ODONTOMEDICAL Comrcio Ltda R. Acre, 1.442 Amrica Cep: 49080-010 Tel: (79) 241-3131 / Fax: (79) 241-4400 Cel: (71) 8814-1920 E-mail: odontomedical@infonet.com.br ARACAJU / IF - Keller

SO PAULO Capital MEDESOL Prod. Md. Hosp. Ltda R. Guaraciama, 42 Jd da Sade Cep: 04153-070 Tel: (11) 5058-9334 / Fax: (11) 5058-9698 Cel: (11) 9988-1904 (Edison Luiz) / 9995-7828 (Wilson) E-mail: medesol@superig.com.br SEGURAMED Com. Of Mat. Equip. Hosp. Av. Gov. Ademar Pereira of Barros, 120/126 Cep: 03454-070 Tel: (11) 6721-4414 / Fax: (11) 6721-0159 Cel: (11) 9996-2439 (Hamilton) / (11) 9191-1177 (Rodrigo) E-mail: seguramed@seguramed.com.br Guarulhos / Jundia / Itatiba / Bragana and region BIOCOM Ltda R. das Orqudeas, 321 Mirandpolis Cep: 04050-000 Tel / Fax: (11) 5585-1913 Cel: (11) 9976-3916 (Fbio Souza) / (11) 9913-9227 (Ktia) E-mail: directria@biocomtec.com.br Itapecerica da Serra / Taboo W/ MD Wassimon Fonseca of Brito R. Augusto Hog, 129 Guarulhos Cep: 07172-200 Tel / Fax: (11) 6432-4352 Cel: (11) 9993-9847 (Wassimon) / (11) 9515-3004 (Edson) E-mail: wmed.kt@terra.com.br Piracicaba / Botucatu and region SPEED MED Paulo Sussumu Av. Moaci, 534 Apto 54A - Moema Cep: 04083-001 Tel / Fax: (11) 5042-1105 Cel: (11) 9939-0074 E-mail: speedmed@uol.com.br ABCD / Baixada Santista / Litoral SP / Vale do Ribeira WORK AND LIFE Comercial Ltda R. das Roseiras, 53 Vl. Bela Cep: 03144-090 Tel / Fax: (11) 6345-9595 Cel: (11) 8139-4600 (Nilmar) / (11) 8139-4500 (Alexian) E-mail: work@workandlife.com.br ARE PAULO / SP Alexian / Nilmar Campinas and region LAC Com. Manut. Equip. Md. Hosp. Ltda R. Henrique Nazar Martins, 59 Cep: 13085-005 Tel / Fax: (19) 3289-4449 / Cel: (19) 9791-3808 E-mail: vendas@lacmedic.com.br CAMPINAS / SP Helio Nei Region High Paulista So Jos do Rio Preto and region ULYMED Com. e Representaes R. dos Bombeiros, 227 Boa Vista Cep: 15025-420 Tel / Fax: (17) 234-3825 Cel: (17) 9772-6272 E-mail: ulymed@terra.com.br ARE JOS DO RIO PRETO / SP Ulysses / Bete Region Nordeste CIRRGICA VILA Ltda Tel / Fax: (16) 636-5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos CIRRGICA NEVES Ltda. R. Presidente Vargas, 169 Cep: 17501-550 Tel / Fax: (14) 3413-2483 Cel: (14) 9601-2990 E-mail: cir.neves@terra.com.br MARLIA / SP Odair Vale do Paraba ANESTEMINAS Ltda Tel: (35) 3423-3348 / Fax: (35) 3425-6309 / Cel: (35) 9191-9000 (Luiz Carlos) / (11) 9939-3683 (Carlos) / (35) 9191-0011 (Hugo) E-mail: anesteminas@anesteminas.com.br

Sales and Show -Room: R. Bertioga, 385 Cep: 04141-100 So Paulo SP S.A.C.: (55 0xx11) 5586-1100 Tel: (55 0xx11) 5586-1000 Fax: (55 0xx11) 5589-8072 E-mail: ktvendas@takaoka.com.br Home page: www. takaoka.com.br

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TAKAOKA INTERNATIONAL DEALERS

SOUTH AMERICA BRASMED S/A Anesthesia Line Talcahuano, 958 L. 416 CF 1013 Tel: (54114) 814-3677 Fax: (54114) 814-3813 E-mail: info@brasmed.com.ar BUENOS AIRES ARGENTINA - Sra. Ana Magalhes ING. CARUSO SRL ICU Line Burela, 1957 (1431) Tel: (54114) 522-1317 Fax:(54114) 523-4919 E-mail: ing.caruso@ciudad.com.ar BUENOS AIRES ARGENTINA - Ing. Miguel Caruso IMPORTADORA FERNANDO Calle Tucabaca, Esq. Burapucu Casilla 5 Tel: (5913) 354-2525 Fax: (5913) 354-2526 E-mail: imp-fernando@cotas.com.bo SANTA CRUZ BOLVIA - Sr. Erwin Hurtado MEDI MARK MERCADOTECNICA MEDICA Av. Argentina, 2001 casi esquina Villalobo Tel / Fax: (5912) 224-6493 E-mail: medi_mark@yahoo.com LA PAZ BOLIVIA - Sr. Leopoldo Antezana INGEMEDICA S.A ICU Line Manuel Galecio, 231 entre Ximena y Boyac Tel: (5934) 230-3173 / 230-3185 Fax: (5934) 230-1428 E-mail: ingemedica@gye.satnet.net GUAYAQUIL ECUADOR - Sr. Ernesto Rovayo COMERCIALIZADORA DE PRODUCTOS FCV Calle, 155 A NR. 23 -58 Floridablanca Tel: (577) 639-6767 Ext. 810 Fax: (577) 639-2595 E-mail: comercial@fcv.org SANTANDER COLOMBIA - Ing. Giovanni Gutierrez BIOXEL S/A Araucana, 1277 CP. 11400 Tel: (5982) 606-0172 Fax: (5982) 600-5435 E-mail: marielk@bioxel.com Dra. Mariel Kuehr / Carlo s Bonilla MONTEVIDEO URUGUAY AREAMEDICA EL BOSQUE, C.A. Av. El Carmen, Quinta Torre Lavega, Local n1, Urbanizacin el Bosque, Municipio Chacao Tel: (58212) 731-3913 Fax: (58212) 731-3928 E-mail: carlosgaravito@cantv.net Sr. Carlos Garavito / Abel Maestre CARACAS VENEZUELA A.JAIME ROJAS S/A JR. Garcia Y Garcia, 870 Barranco Tel: (511) 477-8410 Fax: (511) 477-1316 E-mail: import@ajaimerojas.com LIMA PERU - Sr. Juan Santa Cruz CARIBBEAN & CENTRAL AMERICA 2N S.A DE CV Primeira Calle Ponient, 2904 3. Planta Local 3 Cond. Monte Maria Tel: (503) 260-5288 Fax: (503) 208-1895 E-mail: nuila02@yahoo.com SAN SALVADOR EL SALVADOR - Sr. Rene Nuila EUROTADE IBERICA Aerocaribean, km 1 1/2 Tel: (537) 540-000 E-mail: eurotade@enet.cu LA HABANA CUBA - Sr. Igncio Quintero IMPORTADORA JAEGER S/A 12 Calle 8-53 Zona 01 Tel: (502) 232-2285 Fax: (502) 251-4137 E-mail: jaeger@intelnet.net.gt GUATEMALA CA GUATEMALA - Mr. Alexander Huschke MEDI EQUIPOS S.A C./ Wenceslao Alvarez # 260 Zona Universitria (UASD) Tel: (809) 688-5520 Fax: (809) 221-0124 E-mail: medequip@tricom.net SANTO DOMINGO REPBLICA DOMINICANA CORPORACION MEDICA INTERNATIONAL Baja California, 167-102 CP 06760 Col Romasur Tel: (5255) 5264-7006 Fax: (5255) 5264-7593 E-mail: leguisi@yahoo.com.mx MEXICO CITY MEXICO - Sr. Leonardo Guinea TECNOLOGIA HOSPITALARIA RYM Avenida 12, Calle 28 Plz Aventura Tel: (506) 223-7446 Fax: (506) 255-3165 E-mail: thrymsa@racsa.co.cr SAN JOSE COSTA RICA - Sr. Roberto Molina ULTRAMED Avenida Ricardo Arango Y Calle 53 Ed. Fursys Tel: (507) 263-7087 Fax: (507) 269-3561 E-mail: allan@ultramedcorp.com PANAMA CITY PANAMA - Sr. Allan Figueroa SNCHEZ & COLLADO CIA LTDA Ferretera Sinsa, 75 Vs. Altamira Deste, 448 Tel: (505) 278-0999 Fax: (505) 278-4928 E-mail: sacol@ibw.com.ni MANAGUA - NICARAGUA - Sr. Abelardo Snchez DIST. EQUIPOS MEDICOS Col. Ruben Dario, 2117 Tel: (504) 232-3544 Fax: (504) 232-2503 E-mail: demlf@multivisionhn.net TEGUCICALPA HONDURAS - Sra. Yma de Sabillon ASIA / FRICA BEYOND ENGINEERING Nr. 30, Jalan Maju 4 Taman Pelangi Tel/Fax: (607) 331-4262 E-mail: bydeng@tm.net.my JOHOR BAHRUI MALAYSIA - Mr. A. Dass HI-MED EGYPT 41 El-Montaza St. Tel: (202) 240-2591 Fax: (202) 635-2977 E-mail: hanyhimed@hotmail.com CAIRO EGYPT - Dr. Hany K. El- Shafei GR MEDI CORP 5, Kaveri Street CP 600073 Tel: (9144) 2227-5297 Fax: (9144) 2227-1206 E-mail: grmedi@satyam.net.in GOMATHI NAGAR CHENNAI - Mr. Krishna Kumar PROGRESSIVE MEDICAL CORP. 29 F/Antel Global Corporate Center n 3 Dona Julia Vargas Avenue Tel: (632) 687-7788 Fax: (632) 687-2190 E-mail: hhclim@pmcgroupl.com PASIG CITY PHILIPPINES - Mr. Homer C. Lim PT BERSAUDARA JL Penjernihan Raya, 38 Tel: (6221) 5701-1467 Fax: (6221) 5701-1468 E-mail: sholahudin@bersaudara.com JAKARTA INDONESIA - Mr. Sholahudin Husni SIGMA STAR MED LTDA 1089/1091 Onnuch Road, Suanluang Tel: (662) 742-1015 Fax: (662) 311-3550 E-mail: starmed@ksc.th.com BANGKOK THAILAND - Mrs. Kunvadee Egnukal ETHOS TRADE CONCERN EPC 7181 POBOX 8975 Tel: (977 -1) 477205 Fax: (977-1) 473874 E-mail: ethos@wlink.com.np KATHMANDU NEPAL - Mr. Rajesh Man Shrestha BIOLOGIC MEDICAL SYSTEMS Poonawala Terrace, Plo # JM711/5 Offive n6, Mezzanine Floor New M. A. Jinnah Road Karachi 74800, Pakistan Tel: (9221) 492-4029 Fax: (9221) 412-7459 E-mail: lighting@cubexs.net.pk PAKISTAN Mr. Shahid Suri MIDDLE EAST NOMAS TRADING EST P.O.BOX 105823 Riyadh 11 656 Tel: (9661) 472-5862 Fax: (9661) 472-5867 E-mail: nomas@nomas-nte.com SAUDI ARABIA - Mr. Jamil H.Al Shahed ABAJI CO. Eskandaroon Street POBOX 11096 Tel: (963 -21) 228-3216 Fax: (963-21) 224-0042 E-mail: jamilia@net.sy ALEPPO SYRIA - Mr. Jamal Abaji EUROPE LA BOUVET Av. Bruselas, 38 Tel: (341) 726-4229 Fax: (341) 356-6101 E-mail: grupacer@teleline.es MADRID ESPAA - Mr. Jorge Perez UAB REMEDA 29, Siltnamiu Tel: (3702) 36 2028 Fax: (3702) 36 2130 E-mail: remeda@takas.it Mr. Romaldas Bogusis / Mr. R. Jonelis VILNIUS 2043 LITHUANIA PROMEI LTDA. Rua do Fetal, lote 5 Forno s Tel: (3512) 3943-1198 Fax: (3512) 3943-1700 E-mail: rcruz@promei.pt COIMBRA PORTUGAL - Sr. Ramos da Cruz B&MC CARDIO-VOLGA 36, Sverdlov, Volzhsky Tel: (7-8443) 31 2221 Fax: (7-8443) 31 2523 E-mail: irina@bimcvol.vlz.ru VOLGOGRAD RUSSIA - Mrs. Irina Khorochoun

FOR MORE INFORMATION: R. Bertioga, 385 Cep: 04141-100 So Paulo SP Brazil Tel: (5511) 5586-1089 Fax: (5511) 5586-1052 E-mail: comex@takaoka.com.br www.takaoka.com.br

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K.TAKAOKA TECHNICAL ASSISTANCE

K. TAKAOKA Indstria e Comrcio Ltda., informs that only its own Technical Service Centers are authorized to provide Technical Assistance to the equipment supplied by it.

Services provided by third parties may bring significant risks, because the origin of the parts used is unknown and the labor does not comply with the strict standards established by K.TAKAOKA.

We cannot warrant the correct operation of equipment manufactured by us, which has been repaired by non-authorized people.

Any request for Technical Assistance and Preventive Maintenance services, whether through agreement or not, shall be made directly to K.TAKAOKA or to one of its exclusive authorized distributors.

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K. TAKAOKA AUTHORIZED TECHNICAL ASSISTANCE

ALAGOAS CASA DO MDICO R. Roberto Simonsen, 412 Cep: 57052-675 Tel/Fax: (82) 338-8777 Cel: (82) 9381-2526 E-mail: compras_cmedico@hotmail.com MACEI / AL - Rogrio

MATO GROSSO DO SUL CENTRO AMRICA Mat. Mdicos e Hospitalares Ltda R. Rui Barbosa, 3845 Cep: 79002-363 Tel / Fax: (67) 324-1212 / 324-9413 / 324-5003 Cel: (67) 9983-1982 E-mail: camerica@brturbo.com CAMPO GRANDE / MS Mauro Boer / Moacir

RIO GRANDE DO SUL HOSPITRADE Ltda R. So Manoel, 1994 Santana Cep: 90620-110 Tel/Fax: (51) 3217-6771 / 3223-1436 / 3223-0460 Cel: (51) 9956-0510 (Carlos) / (51) 9961-4506 (Artur) E-mail: htrade@hospitrade.com.br PORTO ALEGRE / RS Carlos / Artur SANTA CATARINA HOSPITLIA Cirrgica Catarinense Ltda R. Prof. Custdio de Campos, 281 Cep: 88090-720 Tel: (48) 241-1100 / 241-5567 / Fax: (48) 241-5585 Cel: (48) 9982-1608 (Elson) / (48) 9981-2602 (Carlos) E-mail: hospitalia.cirurgica@terra.com.br FLORIANPOLIS / SC - Elson / Carlos SERGIPE ODONTOMEDICAL Comrcio Ltda R. Acre, 1.442 Amrica Cep: 49080-010 Tel: (79) 241-3131 / Fax: (79) 241-4400 Cel: (71) 8814-1920 E-mail: odontomedical@infonet.com.br ARACAJU / IF - Keller SO PAULO Campinas and region LAC Com. Manut. Equip. Md. Hosp. Ltda R. Henrique Nazar Martins, 59 Cep: 13085-005 Tel/Fax: (19) 3289-4449 / Cel: (19) 9791-3808 E-mail: vendas@lacmedic.com.br CAMPINAS / SP Helio Nei Alta Paulista Region So Jos do Rio Preto and region CLINITCNICA Equipamentos Mdicos Ltda R. Major Joo Batista Frana,2108 Cep:15025-610 Tel/Fax: (17) 212-2566 / 212-2995 E-mail: clinitecnica@goldnet.com.br ARE JOS DO RIO PRETO / SP Vlter Northeastern Region CIRRGICA VILA Ltda Tel/Fax: (16) 636-5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos CIRRGICA NEVES Ltda. R. Presidente Vargas, 169 Cep: 17501-550 Tel/Fax: (14) 423-2483 Cel: (14) 9601-2990 E-mail: cir.neves@terra.com.br MARLIA / SP Odair Vale do Paraba ANESTEMINAS Ltda Tel: (35) 3423-3348 / Fax: (35) 3425-6309 / Cel: (35) 9191-9000 (Luiz Carlos) / (11) 9939-3683 (Carlos) / (35) 9191-0011 (Hugo) E-mail: anesteminas@anesteminas.com.br

AMAZONAS / RONDNIA DANI Com. Repres. Prest. Services Ltda R. 10 de Julho, 489A Cep: 69010-060 Tel: (92) 622-2700 / 622-2701 Fax: (92) 2333093 Cel: (92) 9146-0305 (Nelson) / (92) 9146-0304 (Andr) E-mail: dani.compras@horizon.com.br MANAUS / AM - Nelson

MINAS GERAIS ARS Eletromedicina Ltda (Juiz de Fora) R. Monsenhor Gustavo Freire, 114 Cep: 36016-470 Tel/Fax: (32) 3216-6617 Cel: (32) 9987-4062 (Gilson) E-mail: arsvend@uai.com.br JUIZ OF FORA / MG Gilson

BAHIA ODONTOBIOMED Commercial Ltda Av. Anita Garibalde, 1815 Ed. CME Lj. 11 Bl. A - Ondina Cep: 40170-130 Tel: (71) 245-6547 Fax: (71) 237-0384 / 2359390 Cel: (71) 8814-1920 / 9143-6547 / 9983-5683 E-mail: odontobiomed@uol.com.br SALVADOR / BA - Keller

BELMED Eletromedicina Ltda (BH and Greater BH) R. Alvares Maciel, 337 Cep: 30150-250 Tel: (31) 3241-1913 / Fax: (31) 3241-2723 Cel: 31 9974 8373 (Carlos) / (31) 9981-1913 (Delio) E-mail: belmed@belmed.com.br BELO HORIZONTE / MG - Carlos / Dlio / Adriana

CEAR HOSP TRADE do Brasil Rua Dom Lino, 672 A Parquelndia Cep: 60450-280 Tel/Fax: (85) 281-7400 E-mail: commercial@hosptrade.com.br FORTALEZA / CE Paulo Marcelo Gomes

ANESTEMINAS Ltda (North and South) Av: Cel Alfredo Custdio of Paula, 193 Cep: 37550-000 Tel: (35) 3422-8532 / Fax: (35) 3425-6309 Cel: (35) 9191-9000 (Luiz Carlos) (11) 9939-3683 (Carlos) E-mail: anesteminas@anesteminas.com.br POUSO ALEGRE / MG - Luiz Carlos

DISTRITO FEDERAL CTI Com. Repres. Assist. Tcnica Ltda SHN, Qd. 02 Bl. E Ed. Kubitscheck Plaza Sl. 69 Sobreloja 79 Cep: 70702-904 Tel/Fax: (61) 327-6166 / 327-5483 / 329-3583 Cel: (61) 9981-0040 (Marco) / (61) 9983-2830 (Gilvan) E-mail: cti.com@uol.com.br BRASLIA / DF - Marco and Gilvan

CIRRGICA VILA Ltda (Tringulo Mineiro) R. Pde. Euclides, 671 Campos Elseos Cep: 14080-200 Tel/Fax: (16) 636-5412 Cel: (16) 9791-3984 E-mail: avila@convex.com.br RIBEIRO PRETO / SP - Joo Carlos

PAR MEDICINAL Com. e Repres. Ltda Av. Cipriano Santos, 580 Cep: 66070-000 Tel/Fax: (91) 266-0203 Cel: (91) 9981-8137 E-mail: medcinal@amazon.com.br BELM / PA - Arlindo

ESPRITO SANTO EMILTEC Assist. Tec. Equip. Mdicos Ltda R. Leoni Souza Guedes, 12 Cep: 29040-550 Tel/Fax: (27) 3222-2666 / (27) 3222-0131 Cel: (27) 9981-2267 VITRIA / ES Svio

GOIS MS Equipamentos Hospitalares Ltda Av. Areio, 595 Setor Pedro Ludovico Cep: 74820-370 Tel/Fax: (62) 281-1177 Cel: (62) 9972-2187 E-mail: mseh@terra.com.br GOINIA / GO - Divino

PARABA / PERNANBUCO / RIO GRANDE DO NORTE ANESTENORTE Com. Repres. Ltda R. Costa Gomes, 163 Madalena Cep: 50710-510 Tel: (81) 3228-1722 Fax: (81) 3228-4261 Cel: (81) 9111-0764 (Hlio) / (81) 9172-1200 (Gilberto) E-mail: anestenorte@uol.com.br RECIFE / PE - Hlio Lucena / Gilberto

MARANHO QUARK Electrnica de Preciso e Comrcio Ltda Rua N, Qd 13 n04 Planalto Anil III Cep: 65053-212 Tel/Fax: (98) 238-7034 Cel: (98) 9973-0858 E-mail: quark.ma@elo.com.br SO LUIS / MA Roberto Sasso

PARAN MEDITCNICA Repres. Equip. Hosp. Ltda R. Chile, 1107 Rebouas Cep: 80220-180 Tel: (41) 332-6364 Fax: (41) 332-8766 Cel: (41) 9972-3881 (Lcio) / (41) 9975-1336 (Lori) E-mail: meditecnica@terra.com.br CURITIBA / PR - Lcio / Lori PIAU REMAC Odontomdica Hospitalar Ltda R. Barroso, 1.009 Centro Cep: 64000-130 Tel: (86) 221-3011 Fax: (86) 221-2280 Cel: (86) 9981-1108 (Srgio) / (86) 9432-4406 (Ana) E-mail: remacvendas.takaoka@veloxmail.com.br TERESINA / PI Srgio / Ana Valeska RIO DE JANEIRO RIO TAK Com. e Repres. Mat. Cirrg. Ltda R. Sacadura Cabral, 81 Grupo 701 Cep: 20081-260 Tel: (21) 2263-9602 Fax: (21) 2253-3458 Cel: (21) 7837-8864 (Roberto) / (21) 9985-0787 (Marcos) E-mail: riotak@terra.com.br RIO DE JANEIRO / RJ Roberto / Marcos / Felipe

LOCALITIES SERVICED BY THE HEADQUARTERS (55 0xx11) 5586-1001 ABCD Itapecerica da Serra Baixada Santista and Litoral SP Itatiba Botucatu and region Jundia Bragana and region Piracicaba Capital and Grande So Paulo Sorocaba Guarulhos Taboo

MATO GROSSO MEDLAB Com. Equip. Mdico-Hospitalares Av. So Sebastio, 1603 Cep: 78020-510 Tel/Fax: (65) 624-3824 Cel: (65) 9982-6263 (Anselmo) / (65) 9981-7407 (Holanda) E-mail: medlabmt@terra.com.br CUIAB / MT - Anselmo / Holanda

S.A.C.: (55 0xx11) 5586-1100 Sales and Show-Room: R. Bertioga, 385 Cep: 04141-100 So Paulo SP Tel: (55 0xx11) 5586 1000 / Fax: (55 0xx11) 5589 8072 E-mail: ktvendas@takaoka.com.br Home page: www. takaoka.com.br Last Updating 06.18.04

Manual Code: 204010258_002

101

Information for Technical Assistance

This card must be filled-in and returned together with the equipment. Name:

Hospital:

Address:

Phone:

District:

Mail Code: -

City:

State

Description of the problem:

Rua Bertioga, 385 CEP 04141-100 So Paulo/SP Tel.: (55 0xx11) 5586-1000/1001 Fax.: (55 0xx11) 5589-7313

Information for Technical Assistance

This card must be filled-in and returned together with the equipment.. Name:

Hospital:

Address: Phone: District:

Mail Code: -

City:

State

Description of the problem:

Rua Bertioga, 385 CEP 04141-100 So Paulo/SP Tel.: (55 0xx11) 5586-1000/1001 Fax.: (55 0xx11) 5589-7313

Manual Code: 204010258_002

102