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S.P.L.

TBH-400 User manual

User manual English

TBH-400
Testing system for function tests of clinical thermometers, cardiac output-,
invasive and noninvasive blood pressure devices

Instructions for the user: This manual is supplied in the form of a loose-leaf
publication. Any necessary updates and additional pages can thus be included
without difficulty later so that you always have the latest version of the manual.
We provide you with supplements and/or changes to your manual along with
technical modifications that are made to your testing system.

The DIN/VDE symbols and drawings shown in this manual have been reproduced
with the permission of the Deutsches Institut für Normung e.V. (DIN: German
Institute for Standardization) and the Verband Deutscher Elektrotechniker e.V.
(VDE: German Association of Electrical Engineers). In applying the relevant
standards, it is important to use the versions with the most recent date of issue.

We reserve the right to make any changes to the information in this manual
without prior notice. S.P.L. Elektronik accepts no responsibility in this regard. The
software that comes with this product is supplied within the framework of a
License Agreement. The software may be used and copied only in accordance
with the terms and conditions of the License Agreement.

All rights pertaining to reprinting and reproducing the manual, or parts thereof,
are reserved. No part of the manual may be reproduced in any form whatsoever
(photocopy, microfilm or any other procedure) or processed, reproduced or
distributed using electronic systems without prior written approval from S.P.L.
Elektronik.

Other products mentioned by name are trademarks or registered trademarks of


their respective companies.

S.P.L. Elektronik
Forstweg 1
D - 14656 Brieselang
GERMANY

Tel. +49 33232 39915


Fax +49 33232 39911

6th. Edition, 2011

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S.P.L. TBH-400 User manual

European Union Declaration of Conformity

Nr. 20110104250

Hersteller: S.P.L. Elektronik


Forstweg 1
14656 Brieselang
Bundesrepublik Deutschland

Produktbeschreibung: Prüfgerät zur Funktionsprüfung von medizinischen


Thermometern, Herzzeitvolumen-, invasiven und nichtinvasiven
Blutdruck-Geräten

Modell: TBH-400

Konform mit den Bestimmungen folgender EG-Richtlinien:

Richtlinie 2006/95/EG des Europäischen Parlaments und des Rates


vom 12. Dezember 2006 (Niederspannungsrichtlinie)

Richtlinie 2004/108/EG Dez. 2004,


EMVG Gesetz über die elektromagnetische Verträglichkeit von Betriebsmitteln

Angewendete Normen und technische Spezifikationen:

 EN 61010-1:2004,
Sicherheitsanforderungen an elektrische Mess-, Steuer-, Regel-, und Laborgeräte,
Teil1 Allgemeine Anforderungen

 EN 61326-1:2006
Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen

 EN 61000-4-2:12.2009
 EN 61000-4-3:06.2008
 EN 61000-4-4:2005
 EN 61000-4-5:2007
 EN 61000-4-6:12.2009
 EN 61000-4-7:12.2009
 EN 61000-4-8:2001
 EN 61000-4-11:2005

Brieselang, den 02.02.2011

Bernd Schulz
S.P.L. Elektronik

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S.P.L. TBH-400 User manual

1 INTRODUCTION .........................................................................................................................4

2 TECHNICAL DATA .....................................................................................................................5

3 FUNCTION DESCRIPTION .......................................................................................................7

3.1 FUNCTION OF ACS 10 TRAVELLER .............................................................................................8


3.2 FUNCTION INSTRUCTION POWER SUPPLY .................................................................................10

4 OPERATING GUIDE .................................................................................................................11

4.1 OPERATING PHILOSOPHY ..........................................................................................................11


4.2 MAIN MENU ................................................................................................................................12
4.3 SIMULATOR ................................................................................................................................13
4.3.1 TEMPERATURE .........................................................................................................................13
4.3.2 BLOOD PRESSURE .....................................................................................................................13
4.3.2.1 INVASIVE ...............................................................................................................................14
4.3.2.2 NOT INVASIVE........................................................................................................................17
4.3.2.3 STOP WATCH..........................................................................................................................22
4.3.3 CARDIAC OUTPUT .....................................................................................................................23
4.4.1 CONFIGURATION .......................................................................................................................25

5 WIRING DIAGRAMS ................................................................................................................27

6 SIGNAL OUTPUT ......................................................................................................................31

6.1 SIGNAL GENERATION .................................................................................................................31


6.1.1 TEMPERATURE ........................................................................................................................31
6.1.2 INVASIVE BLOOD PRESSURE ...................................................................................................31
6.1.2.1 SIGNALFORMS........................................................................................................................32
6.1.3 NON INVASIVE BLOOD PRESSURE ...........................................................................................38
6.1.3.1 ACCESSORIES ........................................................................................................................39
6.1.4 CARDIAC OUTPUT ...................................................................................................................40
6.2 FUNCTIONS OF TBH-400 ...........................................................................................................41
6.3 FUNKTIONEN DES TBH-400 IM PC-BETRIEB ...........................................................................43

7 DURCHFÜHRUNGSHINWEISE ..............................................................................................44

7.1 TEMPERATUR (M) ......................................................................................................................44


7.2 INVASIVER BLUTDRUCK (S) .......................................................................................................44
7.3 NICHTINVASIVER BLUTDRUCK (M)...........................................................................................45
7.4 HERZZEITVOLUMEN (S).............................................................................................................47

8 SERVICE AND CALIBRATION ..............................................................................................48

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S.P.L. TBH-400 User manual

1 Introduction

TBH-400 is a test equipment for the following medical functions:


• temperature- (medical thermometer)
• invasive blood pressure (IBP)
• non invasive blood pressure (NIBP)
• cardiac output (CO), thermo dilution method

TBH-400 can be used as standalone or PC-controlled test system. The LCD


serves the menu diagram and the test steps. After the choice of only a few
parameters the appropriate simulation can be used. The operation of the test
equipment is cursor-controled. With a few YES / NO decisions the different
functions of the test equipment are activated. The choice made last remains also
after switching the test equipment off, so that this not have to be selected again.

To control the TBH-400 a 100% compatible IBM computer with industrial


standards is needed. The communication between the PC and the GM-300
follows through the serial interface (RS-232). Using PC test instructions the
parameters to test can be simulated fully automatic. In the circuit analyzer mode
however all simulation parameters are selected directly and simulated.

The function tester is accommodated in a handy and sturdy light weight metal
case and is characterised by a simple operation with only a few keys. For the
output of the temperature, IBP and CO parameters the respective 4mm sockets
are on the front plate of the test equipment. NIBP simulation is realized by the
NIBP connection (LUER adapter female) at the lower surface of the TBH-400.
The accessories provided are kept into a test box.

Heart of the equipment is an efficient controler ATMEGA 256 from ATMEL. The
generation of the test signals takes place by an resistance networks and D/A
transducers, and on the other hand via an eccentric cam diaphragm pump and a
2/3-way-valve.

Note: At different monitors it can be necessary for simulation and/or


measurement to set the respective monitor into the service menu !

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S.P.L. TBH-400 User manual

2 Technical Data

Mains voltage: ac 83 V – 264 V, ± 10 %, 50 / 60 Hz


It works even over internal accumulator
Nominal power: max. 25 VA
Protection class: Internal power supply
Environmental temperature: +5 - +40 °C
Storage temperature: -10 - +50 °C
Timer: 10 - 60 min in 10 min steps, ± 1 sec
Interface: 1 x RS-232 for PC-connection

Digital display: 4 x 16 char display


Keyboard: 8 key foil keyboard
Accessories: 1 x RS-232 interface cable
Charger or power supply
Digital display: 4 x 16 char display

Mechanical data: Light weight metal case


Dimensions: 140 x 220 x 30 mm (W x H x D)
Weight:: approx. 2,0kg handset
approx. 6,5kg incl. suitcase and accessories

Simulation- and measuring


ranges:

Temperature: 0 - 70°C in 1°C steps, ± 0,01°C

Cardiac output: 3, 5, 7, 9 l/min, ± 0,3 l/min


Blood temperature: 37 °C, ± 0,1 °C
Injectate temperature: 4, 12, 20° C, ± 0,1 °C

Static blood pressure (IBP): 0 - 400 mmHg in 1mmHg steps, ± 1mmHg


Sensitivity (IBP): 5 or 40 µV/ V/ mmHg [V(monitor)]
Dynamic signals (IBP): ± 1mmHG
Aorta radial pressure (ARP) 120 / 80 mmHg
Aorta femoral pressure (AFP) 130 / 70 mmHg
Central vein pressure (CVP) 10 / 0 mmHg
Pulmonary aorta pressure (PAP) 25 / 10 mmHg
Pulmonary-ast-wedge-position 10 / 0 mmHg
(PAWP)
Left ventricle pressure (LVP) 10 / 0 mmHg
Left atrium pressure (LAP) 5 / 0 mmHg
Right ventricle pressure (RVP) 25 / 0 mmHg
Right atrium pressure (RAP) 5 / 0 mmHg
Arrhythmia aorta damped 110 / 80 mmHg
Arrhythmia aorta disturbed 170 / 20 mmHg
Puls rates (IBP): 30 – 150 bpm in 10 bpm steps, ± 2bpm
Puls between 1 arrhythmia: 0-20 in 1 steps

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S.P.L. TBH-400 User manual

Manometer (NIBP): 0 – 750 mmHg in 1mmHg steps, 0,1% FS


Leakage rate measurement 1 – 15 min in 1min steps, ± 0,1 sec
(NIBP):
Puls rate (NIBP): 80 bpm, ± 2bpm
Reference volume (NIBP): 100, 500 ml
Systole (NIBP): 120 mmHg, ± 3mmHg
Diastole (NIBP): 80 mmHg, ± 3mmHg
Limit fall in pressure: 0-20 mmHg in 5mHg steps
Accessories (NIBP): Calibration hand pump
Adapter block with connections
Reference pressure volume 100 and 400 ml
Test bag

Connection cables: Please look at datasheet “connection cables”

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S.P.L. TBH-400 User manual

3 Function description
TBH-400 produces test signals for the following types of device:
• Temperature – medical thermometer
• Invasive blood pressure – patient monitor, IBP-systems
• Non invasive blood pressure – patient monitore, NIBP-systems
• Cardiac output – patient monitors, CO-systems according to the Stewart-
Hamilton-Method

The function tester is operated over an internal accumulator or a power supply.


During the load cycle the TBH-400 cannot be switched on; an operation is
possible thereby only after the loading.

TBH-400 can be used as standalone equipment or PC-controlled.

Temperature simulation serves for the output of temperature levels by


appropriate resistance values on temperature units in patient monitors and/or
medical thermometers. The connection from the function tester to the patient
monitor is e.g. made by an appropriate connection cable,
STA_SPL611_YSI_N401. Temperature simulation is certified for the calibration of
medical thermometers.

IBP simulation serves to the output of static and dynamic pressures and/or
pressure sequences. The appropriate DAC signals are spent over the suitable
connection cable, e.g. STA_SPL62X_PhilipsHP, to IBP units in patient monitors.
IBP simulation is intended for the plausibility check within a safety test control.

NIBP simulation serves for the output of dynamic pressure sequences by


pumping and valve gear control at NIBP units in patient monitors and medical
blood pressure devices. The moreover pressure values can be measured over
the inserted pressure sensor (manometer function). This pressure sensor forms
likewise the basis for the leakage rate measurement and the measurement of the
decrease of pressure rate. The connection to the blood pressure system is made
by the adapter box with the appropriate connecting piece. NIBP simulation serves
only for the plausibility check, as this is descriptive in the DIN EN 1060-3.

CO simulation serves for the output of CO parameters by appropriate resistance


values and DAC signals at CO units in patient monitors. Likewise an appropriate
foot or hand switch can be simulated; Signal output over the sockets +OUT and
-OUT. The CO system is connected over the respective cable, e.g.
STA_SPL64X_PhilipsHP, to the function testers. CO simulation is intended for
the plausibility check within a safety test control and in addition limited to CO
systems, which measure according to the thermo dilution method.

The multitude of the indicated parameters are variable.

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S.P.L. TBH-400 User manual

3.1 Function of ACS 10 Traveller

Battery pack charger (no power supply)

Operating Instructions / Use of the charger

Charger / discharger for nickel cadmium (NiCd) and nickel metal hydride (NiMH)
battery packs of 1 – 10 cells (1.2 – 12.0 V) with a capacity of 800 – 7,200 mAh.

Features
- For worldwide use thanks to a switch mode power supply (100 – 240 V
AC)
- Microprocessor controlled charging
- Testing cycle at the beginning of the charging in order to identify the
number of cells and to identify and report defective battery packs
- Short circuit detection and electronic protection against reversed polarity
- Battery pack charge status at the beginning of the charging is not
important
- Microprocessor controlled charge status monitoring during the whole
charging time
- Includes safety features such as voltage gradient supervision and –delta V
switch off, plus a safety timer
- Optional discharging of the battery pack before use by pressing the
discharge button. Automatic switching over to fast charging after
discharge
- LED status indication
- Automatic switching over to trickle charge once fully charged

Indicators
LED red “Power” (1): Steady light shows that the charger is ready for use. It lights
once the charger is plugged in.

LED red “Charge” (2): Steady light indicates the fast charging process after
connection the battery pack.

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S.P.L. TBH-400 User manual

LED green “Ready” (3): Steady light indicates the battery pack is fully charged.
After approx 2 minutes it switches to flashing, which indicates trickle charging.

Once the battery pack is connected, the testing cycles is initiated and the green
LED flashes for around 1 minute.

If it carries on flashing and the red LED “Charge” does not light, it indicates that
the battery pack is not connected properly and maybe has an incorrect polarity.
LED yellow “Discharge” (4): Steady light indicates the discharging process after
pressing the yellow button. The LED “Ready” for around 1 minute indicating the
testing cycle.

Controls and Accessories


Discharge button (5): Press this button for about tow seconds to start the optional
discharging process of the battery pack.

Attention
Charge only nickel/cadmium (NiCd) or nickel/metal-hydride (NiMH) battery packs.
Danger of explosion if other of batteries are inserted.

Safety Instructions

Do not attempt to open the charger. Keep the charger in a dry place (indoor use
only). In order to avoid the risk of fire and/or electric shock, the charger must be
protected against high humidity and water. Do not plug in the charger it there are
any signs of damage to the housing, mains pins cables or connectors. In case of
a defect please return to an authorised service centre. Keep the charger out of
reach of children. If the safety instructions are not followed, this may lead to
damage to the charger or batteries or even to serious injury to the user.

Operation

Connect the charger to the mains: The red LED “Power” lights and indicates the
charger is ready for use.

Connect the charger to the TBH-400: The red LED “Charge” lights and indicates
the charging process. During the testing cycle the green LED “Ready flashes also
but goes out after around 1 minute when the test phase is over. After termination
of the fast charge the charger switches automatically to trickle charge. The red
LED “Charge” is off and the green LED “Ready” is constantly on for approx 2
minutes. After around 2 minutes the indicator changes to green flashing.

If the green LED “Ready” flashes immediately after connecting the TBH-400 and
after around 20 seconds the red LED “Charge” lights up sporadically, this means
that the polarity (+/-) of batteries is not set correctly. Please reverse the polarity of
batteries. If both LEDs are still flashing after reversing or changing the polarity of
batteries and the steady light “Ready” does not light permanently, the battery
pack is defective and cannot be recharged at all. In this case the pack has to be
replaced.

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S.P.L. TBH-400 User manual

The optional discharging procedure can be started by pressing the button for
discharging (5) for about 2 seconds. The yellow LED “Discharge” (4) lights and
indicates the discharging procedure. During the first minute the green LED
“Ready” (3) flashes but should turn off after the test phase. After discharging,
which can in some cases last for several hours, the charger automatically
switches over to fast charging.

Environment

Rechargeable batteries are not to be disposed in domestic waste. Return used


batteries to your dealer or to a battery recycling collection point.

3.2 Function instruction power supply


• APS 1500 Traveller
o 5V (3-12V) universal power supply to the current supply
o Fulfilled Ökodesign guideline 2005/32/EC (EuP)
o Voltage-stabilized and short circuit proof
o Power supply with electronic switch power supply; world-wide
applicable (100-240V AC)
o Maximum output current: 1500mA
o Maximum output power: 18W

Safety instructions !

 In the case of damage of the housing, plug or cable, do not set the device
into operation!
 Equipment has to be operated only in closed, dry areas!
 Separate the equipment in case of nonusage, cleaning and maintenance
from electricity mains!
 Do not open the equipment!

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S.P.L. TBH-400 User manual

4 Operating guide

4.1 Operating philosophy

The device works with eight foil keys.

ESC

upper

left right

lower

Enter

The arrow keys serve the selection in the menu or to the parameter selection.
The enter key serves as start button. With the ESC key the respective program
can be broken off

The selection with is in use at last is stored into the device, so if that is repeated it
must not selected again

Additionally the <F> and the <ON/OFF> keys are available.

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S.P.L. TBH-400 User manual

4.2 Main menu


After switching on the test device the following message appears:

* * * S . P . L . * * *
E l e k T r o n i k
T B H - 4 0 0 N E
V e r s i o n 1 . 0

To turn on the device press and hold the <ON/OFF> key for one second.

To turn off the device press and hold the <ON/OFF> key for one second and
release it after you were asked to release it on the display.

After switching on on the equipment is in the main menue, which consists of the
following points:

T B H - 4 0 0 N E 1 0 0 %

→ S i m u l a t o r
S e t u p

The <up> and <down> keys can be used to move the cursor for choosing one of
the options. Pressing the <ENTER> key you can confirm your selection. The
<ESC> key can be used to exit any menu.

The TBH-400 works in the accumulator or mains operation. When connecting the
battery charger the accumulator charger is activated if necessary automatically.
The charging of the accumulator is shown by flashing (high-speed load) and/or
lights in the display

The charge of the accumulator is supervised internal and indicated on the top
right in the display. With to small accumulator voltage the measurement is
deactivated and switching on is blocked for the prevention of over-dischargings.

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S.P.L. TBH-400 User manual

4.3 Simulator
The Simulator menu contains 3 levels for selection:

T B H - 4 0 0 N E 1 0 0 %
→ B l o o d p r e s s u r e
T e m p e r a t u r e
C a r d i a c O u t p u t

The <up> and <down> keys can be used to move the cursor for choosing one of
the options and by pressing the <ENTER> key you can confirm your selection.
The <ESC> key can be used to exit any menu.

4.3.1 Temperature
After selection „TEMPERATURE“you get a specific submenu for the selection of
the temperature levels

S P L 6 1 1 1 0 0 %
2 2 5 2 Ω / 2 5 ° C
0 ° C . . . 7 0 ° C
→ c u r r e n t : 3 7 ° C

With <up> / <down> keys you can change between the probe selection and the
temperature selection. With <left> / <right> keys you select the temperature
levels and/or the type of probe. The temperature level will be automatically
adjusted after change and does not need to be confirmed with <ENTER>. With
<ESC> the temperature simulation can be left again.

After pressing the <F> key you get directly into the IBP selection menu. The
options are descriptive in the point 4.3.2.1. With <ESC> the IBP selection menu
can be left again and returned to the temperature simulation.

4.3.2 Blood pressure


After selection „BLOOD PRESSURE “you get a specific submenu for the
selection of the appropriate blood pressure simulation; depending upon TBH-400
version with or without NIBP and stop watch.

Version TBH-400E
T B H - 4 0 0 N E 1 0 0 %

→ I n v a s i v e

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S.P.L. TBH-400 User manual

Version TBH-400N
T B H - 4 0 0 N E 1 0 0 %
→ N o t i n v a s i v e
S t o p w a t c h

Version TBH-400NE
T B H - 4 0 0 N E 1 0 0 %
→ N o t n v a s i v e
I n v a s i v e
S t o p w a t c h

4.3.2.1 Invasive
After selection „INVASIV“ you get a further submenu for the selection of
respective simulation.

T B H - 4 0 0 N E 1 0 0 %
→ I B P s t a t i c
S i m u l a t i o n
S e t u p

With <up> / <down> keys you can select the desired kind of option. With
<ENTER> you confirm the selection and the monitor voltage is checked. If the
voltage is available you get into the selection meue for the start of simulation,
otherwise the following message appears:

V o l t a g e
t o l o w

For the static blood pressure the value can be varied between 0-400 mmHg with
<left> / <right> keys. The blood pressure value will adjusted after change
automatically and does not need to be confirmed with <ENTER>. With <ESC>
the statically IBP simulation can be left again.

S P L 6 2 1 1 0 0 %
I B P s t a t i c
0 . . . 4 0 0 m m H g
→ c u r r e n t : 1 5 0 m m H g

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S.P.L. TBH-400 User manual

After selection "SIMULATION" you can select between dynamic signals and
dynamic signals with arrhythmia.

T B H - 4 0 0 N E 1 0 0 %
→ I B P d y n a m i c
I B P A r r h y t h m i a

For the dynamic blood pressure the desired pressure sequence can be selected
with typical pressure values with <up> / <down> keys. The pressure sequence is
confirmed with <ENTER> and computed afterwards. With <ESC> the dynamically
IBP simulation can be left again.
After conclusion of the calculation the simulation starts automatically. With <left> /
<right> keys the pulse rate can be varied.

e.g.. the aorta radialis pressure (ARP) 120 / 80mmHg


S P L 6 2 2 1 0 0 %
A . r a d i a l i s p .
1 2 0 / 8 0 m m H g
→ f ( P u l s e ) : 6 0 b p m

For the arrhythmias the desired pressure sequence can be selected with typical
pressure values with <up> / <down> keys. The pressure sequence is confirmed
with <ENTER>. Afterwards the desired number of pulses between a arrhythmia
must be selected witht <left> / <right> keys and confirmed with <ENTER>.

S P L 6 2 2 1 0 0 %
A . r a d i a l i s D .
1 2 0 / 8 0 m m H g
→ f ( P u l s e ) : 6 0 b p m

Afterwards the calculation of the parameters starts again before the simulation
starts automatically. For the simulation at first a complete pulse will always go
through, before the respective IBP arrhythmia simulation starts. With <ESC> the
IBP arrhythmia simulation can be left again.

S P L 6 2 3 1 0 0 %
N u m b e r P u l s e /
1 A r r h y t h m i a
→ c u r r e n t : 9

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S.P.L. TBH-400 User manual

After selection „SETUP“ you get a further submenu for the selection of different
options:

T B H - 4 0 0 N E 1 0 0 %
→ S e n s i t i v i t y
C a b e l t y p e
M o d e o f O p e r .

The menu item "SENSITIVITY" refers to the sensitivity of the pressure transmitter
or the sensitivity which is set in the IBP system. You can select between 5 or 40
µV/V/mmHg.

T B H - 4 0 0 N E 1 0 0 %
S e n s i t i v i t y
→ 5 µ V / V / m m H g
4 0 µ V / V / m m H g

The selection of the "CABLE TYPE" is important for the simulation. Several
generations of cable types have different impedances, as a result different signal
levels. Thus the simulation for newer and older cable types or IBP system works,
the correct cable type must be selected. Two cable types (type X and type Y) are
distinguished. The supplied cables are accordingly marked.

T B H - 4 0 0 N E 1 0 0 %
C a b e l t y p e :
→ T y p X
T y p Y

The selection of the "MODE OF OPERATION" allows a manual operation. So no


external voltage must be attached to entrance + IN / - IN. A selected reference
voltage can output an IBP signal at the output + OUT /-OUT.

T B H - 4 0 0 N E 1 0 0 %
M o d e o f O p e r . :
→ m a n u a l y
a u t o m a t i c

T B H - 4 0 0 N E 1 0 0 %
U ( R e f e r e n z )
0 , 1 . . . 9 V
→ C u r r e n t : 5 . 0 0 V

NOTE: The mode of operation is reset after each switch on to "automatic"!

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S.P.L. TBH-400 User manual

4.3.2.2 Not invasive


After selection „NOT INVASIV “you get the NIBP-Menu. With <up> / <down> keys
the desired simulation and/or measuring function or setup can be selected. With
<ENTER> the selection is confirmed and changed into the next menu.

T B H - 4 0 0 N E 1 0 0 %
→ S i m u l a t i o n
M e a s u r e m e n t s
S e t u p

NOTE: If still is pressure is in the system, the equipment indicates „over


pressure“ in the display. Subsequently, the pressure must be
discharged.

T B H - 4 0 0 N E

Ü b e r d r u c k !

After selection „SIMULATION“ the zero point adjustment is done and you get
automatically into the simulation menu. The simulation must be started at the test
object (e.g. patient monitor)..

S P L 6 3 3 1 0 0 %
S y s t o . : 1 2 0 m m H g
D i a s t o . : 8 0 m m H g
P r e s s . : 0 m m H g

With <ESC> the NIBP simulation and/or the respective parameter menu can be
left again. Then appears a message that indicates the maximum pressure
occurred during the simulation.

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S.P.L. TBH-400 User manual

NOTE: Depending on hose system the intensity must be varied if necessary.

Manufacturer / Monitor Intensity [%]


Boso Medicus Control 50-60
Datex Cardiocap / Datex Ohmeda AS/3 70-90
Dräger PM8014 70-90
GE Datex-Ohmeda FM 80-100
HP OmniCare CMS24 (NBP Modul) 70-90
HP Viridia Anästhesiemonitor 26C 70-90
Medtronic (Physio-Control )LIFEPACK 12 70-90
Mindray Datascope Passport 2 10-30
Philips IntelliVue MP70 / Serie (NBP Modul) 70-90
Philips SureSigns Serie (NBP Modul) 70-90
ProPaq 100 Serie 70-90
Schiller Argus Pro Life Care / DG5000 70-90
Siemens SC6002XL 70-90
Siemens Sirecust 404-1 (NP Modul) 70-90
Welch Allyn 5300P 50-60
Welch Allyn Atlas 621 / Spot Vital Signs Lxi 10-20
Zoll E-Series 70-90

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S.P.L. TBH-400 User manual

After selection „MEASUREMENTSL“ you get a further submenu for the selection
of different options:

T B H - 4 0 0 N E 1 0 0 %
→ M a n o m e t e r
L e a c k a g e r a t e
P r e s . d r o p r a t e

After selection „MANOMETER“ the zero point adjustment takes place. With the
help of this function the pressure in the NIBP system can be measured excluding.

1 0 0 %
M a n o m e t e r
c u r r e n t p r e s s .
→ 0 m m H g

With <ESC> the manometer function can be left again.

After selection „LEAKAGE RATE“ appears the following parameter menu, in


which the time can be selected with <left> / <right> keys. With <ENTER> the
selection is confirmed and changed into the next menu.

S P L 6 3 2 1 0 0 %

L e a k a g e r a t e
→ T i m e : 5 m i n

After the zero point adjustment the current pressure is indicated. This function
serves to pump up the pressure to the desired initial value; either with the NIBP
system or with the precision hand pump.

1 0 0 %
M a n o m e t e r
c u r r e n t p r e s s .
→ 0 m m H g

After the pressure is stabilized the measurement can be started with <ENTER>.
The time is converted into seconds and down-counted. After the interval, the
result is automatically displayed.

S P L 6 3 2 1 0 0 %
T i m e : 1 2 0 s e k
S t a r t : 2 0 0 m m H g
c u r r e n t : 1 9 9 m m H g

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S t a r t : 2 0 0 m m H g
S t o p : 1 9 8 m m H g
L e a k a g e r a t e
0 . 4 0 m m H g / m i n

With <ESC> the leakage rate measurement and/or the respective parameter
menu can be left again.

After selection „DECREASE OF PRESSURE RATE“ appears a further selection


menu, in which with <left> / <right> keys the desired limit value of the decrease of
pressure rate can be adjusted. With <ENTER> the selection is confirmed and
changed in the next menu.

S P L 6 3 4 1 0 0 %
L i m i t
0 . . . 2 0 m m H g
→ c u r r e n t : 1 5 m m H g

After the zero point adjustment the current pressure is indicated. The function
serves to set the pressure to the desired initial value; either with the NIBP system
or the precision hand pump.

1 0 0 %
M a n o m e t e r
c u r r e n t p r e s s .
→ 2 1 0 m m H g

After the pressure is stabilized the measurement can be started with <ENTER>.
In the display appears the hint that the pressure can be discharged, either
manualy or with the dump valve/button. The measurement starts then
automatically.

S P L 6 3 4 1 0 0 %
N o w p l e a s e
l e t o u t !
→ 2 1 0 m m H g

If the limit value were reached, the measurement is finished and the result of
measurement is indicated in the display.

S P L 6 3 4 1 0 0 %
∆ T i m e : 2 s e k
P r e s . d r o p r a t e
9 7 . 5 0 m m H g / s e k

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With <ESC> the leakage rate measurement and/or the respective parameter
menu can be left again.

Individual parameters for the NIBP simulation can be varied after selecting
"SETUP" in the NIBP menu.

T B H - 4 0 0 N E 1 0 0 %
→ I n t e n s i t y
P u l s e c y c l e

The intensity can be changed after selection "INTENSITY". This setting changes
the amplitude of the pressure signal.

T B H - 4 0 0 N E 1 0 0 %
I n t e n s i t y :
1 0 . . . 1 0 0 %
→ c u r r e n t : 7 0 %

Simulation cycle length can be changed after selection "PULSE CYCLE". The
TBH-400 simulates a typical human pressure curve, including the first and
subsequent pulses. The durations can be varied between "SHORT" and “LONG”.

T B H - 4 0 0 N E 1 0 0 %
P u l s e c y c l e :
→ s h o r t
l o n g

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4.3.2.3 Stop watch

After selection „STOP WATCH“ appears the stop watch menu, in which the time
measurement can be started.

T B H - 4 0 0 N E 1 0 0 %
0 0 : 0 0 : 0 0
S t a r t
E N T E R

After the time measurement was stopped with <ENTER>, the current time is
indicated. Time measurement keeps running in the background and can be
continued with <ENTER>. With <ESC> the stop watch stops and is set to zero.

T B H - 4 0 0 N E 1 0 0 %
0 0 : 0 3 : 4 2
F u r t h e r R e s e t
E N T E R E S C

With <ESC> the stop watch function can be left again.

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4.3.3 Cardiac output

T B H - 4 0 0 N E 1 0 0 %
B l o o d p r e s s u r e
T e m p e r a t u r e
→ C a r d i a c O u t p u t

T B H - 4 0 0 N E 1 0 0 %
→ S i m u l a t i o n
M o n i t o r t y p e

The simulation parameters of CO depend on the monitor and must be selected.


The selection is made in the monitor menu which you get from the simulator
menu.

T B H - 4 0 0 N E 1 0 0 %

c h o o s e m o n i t o r
→ S i e m e n s 4 0 4 - 1

In the following menu with <up> / <down> keys the desired monitor is selected
and confirmed with <ENTER>. This monitor remains stored up to the next
change. With <ESC> the monitor selection can be left again.

NOTE: No own monitors can be added, you get only the listed monitors for the
CO simulation.

After selection „SIMULATION“ appears the first CO-menu, the blood temperature.

S P L 6 4 2 1 0 0 %

T ( b l o o d )
→ c u r r e n t : 3 7 . 0 ° C

With <ENTER> the blood temperature is confirmed and changed into the next
selection menu. Here the injectate temperature can be varied with <left> / <right>
keys.

S P L 6 4 1 1 0 0 %
T ( I n j e c t i o n )
4 ° C , 1 2 ° C , 2 0 ° C
→ c u r r e n t : 1 2 ° C

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Monitors without foot or hand switches indicate the injectate temperature usually
immediately. For monitors with foot or hand switches the starting signal can be
released after connection of the cable with the <F> key. That has again as a
consequence that the injectate temperature is indicated as a check at the
monitor.

With <ENTER> the selection is confirmed and changed into the next selection
menu. With <left> / <right> keys the cardiac output can be varied. The injectate
volumen is fixed and cannot not be varied. With <ENTER> the simulation routine
is started.

S P L 6 4 3 1 0 0 %
C O - V o l u m e
V ( I n j . ) = 1 0 m l
→ c u r r e n t : 5 l / m i n

After that the calculation of the simulation parameters is done, the simulation can
be started with<ENTER>. In addition the monitor must be in the measuring mode.
On the one hand the measurement must be started at fist at the monitor one
behind the other and then at the TBH-400. On the other hand for monitors with
foot or hand switches only at the TBH-400 must be started. Here the main start
impulse is released by the TBH-400 and is led to the monitor.

S P L 6 4 3

S i m u l a t i o n
→ s t a r t ?

After the start of the simulation it is signaled that the simulation is active. If a
simulation process took place, you back get to starting point; a further simulation
can be started. In addition the monitor must be set again into readiness.With
<ESC> CO simulation can be left again.

NOTE: Please note that the calculation constants of the monitor are adapted
to your connection cable. These depend on the type of catheter which
can be simulated. The calculation constant for the provided
connection cable is documented in the data sheet.

Manufacturer / Monitor Catheter constant (CT)


Siemens 404-1 500
Philips / HP 0.562

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S.P.L. TBH-400 User manual

4.4 Setup
After selection „CONFIGURATION“ appears a selection menu, in which with <up>
/ <down> keys the desired function can be selected. With <ENTER> the selection
is confirmed and changed into the next menu.

T B H - 4 0 0 N E 1 0 0 %

→ C o n f i g u r a t i o n
D e f a u l t

Default: The settings, which were made in the individual selection menus, are put
back to default values.

4.4.1 Configuration
After selection „CONFIGURATION“ you get a specific submenu for the
configuration of the following parameters:

T B H - 4 0 0 N E 1 0 0 %
→ T i m e r
C a l i b r a t . D a t e
C h o o s e l a n g u a g e

After selection „TIMER “the desired length of time can be selected with <left>
<right> keys.

T B H - 4 0 0 N E 1 0 0 %
T i m e r
0 - 6 0 m i n
→ c u r r e n t : 3 0 m i n

The timer function makes the automatic disconnection of the testing set possible
during disuse. The TBH-400 changes after approximately 1 min first into the
current savings mode, which is realized by the reduction of the background
lighting. If the current savings mode is reached, at the same time the timer
function starts.
At expiration of the adjusted length of time in the menu timer option, the test
equipment initialize for 5 seconds the disconnection. In the display appears in
addition the message „equipment is switched off “.

After renewed switching the test equipment on again it is in the basic menu.

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S.P.L. TBH-400 User manual

The entry „CALIBRATION DATE “ contains the date and the serial number of the
testing set of the next recommended calibration.

T B H - 4 0 0 N E 1 0 0 %
S e r i e s N o : 1 2 4 3
C a l i b r a t . D a t e :
5 M a y 2 0 1 1

The selection „LANGUAGE“ makes it possible keys to change into another user
language with <left> / <right> keys.

T B H - 4 0 0 N E 1 0 0 %

C h o o s e l a n g u a g e
→ E N G L I S C H

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S.P.L. TBH-400 User manual

5 Wiring diagrams

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6 Signal output

6.1 Signal generation

6.1.1 Temperature
By the interconnection of precision resistances joined in parallel with a very small
ppm rate, accurate resistance values, e.g. like the 400er thermistor series, are
converted for simulation. The resistance values vary thereby between 0,05 to
4100 ohms

6.1.2 Invasive Blood pressure


The operation voltage of the respective transducer (measuring bridge) is
measured by the TBH-400. This operation voltage is divided in appropriate
relation to sensitivity and results an appropriate output voltage. Static as well as
dynamic values are given out over a DAC circuit as voltage (mV).

Example calculation for the output voltage:


UOut [V] = UExc [V] ● Sensitivity [µV/V/mmHg] ● blood pressure [mmHg]
= 5 V ● 5 µV/V/mmHg ● 100 mmHg
= 0,0025 V => 2,5 mV

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6.1.2.1 Signalforms
Typical signal forms are stored in the simulator. An assigned intraarterial catheter
registers a different process of the invasive blood pressure in each region of the
heart. The height of the pressure amplitudes arising with it is dependent on the
position of the catheter point, due to environment cross section, in and at the
heart. The following illustration shows the hearts structure and the places of its
measuring points.

The pressure amplitudes refer to physiological standard values of the


hemodynamic monitoring. [Source: „Klinische Anästhesie“]

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6.1.3 Non invasive blood pressure


The most frequently occurring measuring modules are based on that oszillometric
procedure, less far common are the auscultatory procedure. The static pressures
can be produced by the calibration hand pump. The current pressure is taken up
over a pressure sensor, digitized by a A/D transducer and is available afterwards
as measured value.

At the dynamic simulating the oszillometric measuring method must be taken


notic of. On the monitor side of the diaphragm chamber are the NIBP system and
the pressure sensor attached.
On the opposite side an eccentric cam diaphragm pump, which simulates the
temporally fitting counter-pressure to the relative pressure. Over a 2/3-way valve
the pressure is led into the diaphragm chamber. At the monitor the pressure
simulation is evaluated and values such as systole, diastole, medium arterial
pressure and pulse are calculated.

First the pressure is pumped in the system automatically (e.g. by a monitor) or


manually. If no pulse is detected, the inflatable pressure is reached. The pressure
is then discharged automatically or manually. During the pressure drops the TBH-
400 measures the pressure. When the appropriate pressure level is reached the
TBH-400 begins to pulse previous pulses, the simulation and the subsequent
pulses. After the simulation you can read the values on the display device.

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S.P.L. TBH-400 User manual

6.1.3.1 Accessories

• Pressure volume
o 400 ml + 100 ml made of stainless steel
o 400 ml volume with ball valve disconnectible
o The reference volumes are attached with a neoprene hose and
quick-lock connection to the adapter block

• Calibration hand pump


o Hand pump made of temperature-insensitive material with pump,
adjustment device (adjusting wheel) and fine flow control valve.
o Connected by quick-lock connection to the adapter block
o Maximum pressure: 4-5 bar (3000-3750 mmHg)

• Adapter block
o Material: aluminium
o With connections:
 1 x Luerlock female and 2 x Luerlock male
 Direct monitor connection hose:
Siemens, Philips/Agilent/HP, Maquette/GE
 Connetor and adapter in consignment for manufacturing
own combinations.

• Test bag
o With knee lever fastening and softtouch grip
o Material: polypropylen
o Colour: silver-grey
o External dimensions: 500 x 420 x 175 mm
o Intermediate plate makes storage possible in the upper section.

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6.1.4 Cardiac output


Simulation of cardiac output is realized by digital potentiometers for the injectate
and the blood temperature. From the temporal change of blood temperature /
resistance relationship the monitor can calulate with the additional information of
the fixed injectate volume the cardiac output. The simulation is based on thermo
dilution method, which calculates the cardiac output with the help of the Stewart
Hamilton formula. In principle thereby the area of the curve stands proportionally
to the cardiac output.

CO = VInj • CT • (TB – TI) / TB (t) dt


VInj = injekt volume
CT = catheter constant
TB = blood temperature
TI = injekt temperature
TB(t)dt = blood temperature integrated over time

For the simulation the catheter constant (CT) off the monitor must check or set.
Injekt volume (VInj) must be 10 ml; blood temperature (TB) is fixed at 37 °C. Injekt
temperature (TI) and the cardiac output (CO) can be selected accordingly. After
calculation of the cardiac output signals can be simulated on the monitor.

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6.2 Functions of TBH-400

SPL611 Temperature simulation


Temperature 0 – 70 °C

SPL615 Temperature and IBP static (for IBP-Cablel type X)


Temperature 0 – 70 °C
pressure 0 – 400 mmHg

SPL616 Temperature and IBP dynamic (for IBP-Cablel type X)


Temperature 0 – 70 °C
Type ARP 120 / 70 mmHg aorta radial pressure
AFP 130 / 70 mmHg aorta femoral pressure
ZVD 10 / 0 mmHg central vein pressure
PAP 25 / 10 mmHg pulmonary aorta pressure
PAWP 10 / 0 mmHg pulmonary-ast-wedge-position
LVP 10 / 0 mmHg left ventricle pressure
LAP 5 / 0 mmHg left atrium pressure
RVP 25 / 0 mmHg right ventricle pressure
RAP 5 / 0 mmHg right atrium pressure
Pulse 30 – 150 bpm

SPL617 Temperature and IBP dynamic (for IBP-Cablel type X)


Temperature 0 – 70 °C
Type aorta damped 110 / 80 mmHg
aorta disturbed 170 / 20 mmHg
Pulse 30 – 150 bpm

SPL618 Temperature and IBP static 2 (for IBP-Cablel type Y)


Temperature 0 – 70 °C
pressure 0 – 400 mmHg

SPL617 Temperature and IBP dynamic 2(for IBP-Cablel type Y)


Temperature 0 – 70 °C
Type ARP 120 / 70 mmHg aorta radial pressure
AFP 130 / 70 mmHg aorta femoral pressure
ZVD 10 / 0 mmHg central vein pressure
PAP 25 / 10 mmHg pulmonary aorta pressure
PAWP 10 / 0 mmHg pulmonary-ast-wedge-position
LVP 10 / 0 mmHg left ventricle pressure
LAP 5 / 0 mmHg left atrium pressure
RVP 25 / 0 mmHg right ventricle pressure
RAP 5 / 0 mmHg right atrium pressure
Pulse 30 – 150 bpm

SPL617 Temperature and IBP dynamic 2 (for IBP-Cablel type Y)


Temperature 0 – 70 °C
Type aorta damped 110 / 80 mmHg
aorta disturbed 170 / 20 mmHg
Pulse 30 – 150 bpm

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SPL621 IBP static (for IBP-Cablel type X)


pressure 0 – 400 mmHg
SPL622 IBP dynamic (for IBP-Cablel type X)
Type ARP 120 / 70 mmHg aorta radial pressure
AFP 130 / 70 mmHg aorta femoral pressure
ZVD 10 / 0 mmHg central vein pressure
PAP 25 / 10 mmHg pulmonary aorta pressure
PAWP 10 / 0 mmHg pulmonary-ast-wedge-position
LVP 10 / 0 mmHg left ventricle pressure
LAP 5 / 0 mmHg left atrium pressure
RVP 25 / 0 mmHg right ventricle pressure
RAP 5 / 0 mmHg right atrium pressure
Pulse 30 – 150 bpm
SPL623 IBP arrhythmia (for IBP-Cablel type X)
Type aorta damped 110 / 80 mmHg
aorta disturbed 170 / 20 mmHg
Pulse 30 – 150 bpm

SPL625 IBP static (for IBP-Cablel type Y)


pressure 0 – 400 mmHg
SPL626 IBP dynamic (for IBP-Cablel type Y)
Type ARP 120 / 70 mmHg aorta radial pressure
AFP 130 / 70 mmHg aorta femoral pressure
ZVD 10 / 0 mmHg central vein pressure
PAP 25 / 10 mmHg pulmonary aorta pressure
PAWP 10 / 0 mmHg pulmonary-ast-wedge-position
LVP 10 / 0 mmHg left ventricle pressure
LAP 5 / 0 mmHg left atrium pressure
RVP 25 / 0 mmHg right ventricle pressure
RAP 5 / 0 mmHg right atrium pressure
Pulse 30 – 150 bpm
SPL627 IBP arrhythmia (for IBP-Cablel type Y)
Type aorta damped 110 / 80 mmHg
aorta disturbed 170 / 20 mmHg
Pulse 30 – 150 bpm

SPL631 NIBP manometer


Pressure 0 – 750 mmHg
SPL632 NIBP leakage rate, start pressure, stop pressure
Duration 1 – 15 min
SPL633 NIBP simulation (Pulse cycle short)
Systole 120 mmHg
Diastole 80 mmHg
Intensity 10 – 100%
Pulse 80 bpm

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SPL634 NIBP pressure drop rate, duration, start pressure


Limit 0 – 20 mmHg

SPL635 NIBP simulation (Pulse cycle long)


Systole 120 mmHg
Diastole 80 mmHg
Intensity 10 – 100%
Pulse 80 bpm

SPL642 CO blood temperature


lood temperature 37 °C
SPL641 CO inject temperature
Inject temperature 4, 12, 20 °C
SPL643 HZV CO simulation
Blood temperature 37 °C
Inject temperature 4, 12, 20 °C
Cardiac Output 3, 5, 7, 9 l/min

6.3 Funktionen des TBH-400 im PC-Betrieb


⇒ TBH-400E
SPL611 TBH2 Temperature simulation
SPL615 TBH2 Temperature simulation and IBP static
SPL616 TBH2 Temperature simulation and IBP dynamic
SPL617 TBH2 Temperature simulation and IBP arrhythmiea
SPL618 TBH2 Temperature simulation and IBP static 2
SPL619 TBH2 Temperature simulation and IBP dynamic 2
SPL620 TBH2 Temperature simulation and IBP arrhythmia 2
SPL621 TBH2 IBP static
SPL622 TBH2 IBP dynamic
SPL623 TBH2 IBP arrhythmia
SPL625 TBH2 IBP static 2
SPL626 TBH2 IBP dynamic 2
SPL627 TBH2 IBP arrhythmia 2
SPL641 TBH2 CO inject temperature
SPL642 TBH2 CO blood temperature
SPL643 TBH2 CO simulation

⇒ TBH-400N
SPL631 TBH2 NIBP manometer
SPL632 TBH2 NIBP Leakage rate, start pressure, stop pressure
SPL633 TBH2 NIBP simulation
SPL634 TBH2 NIBP pressure drop rate, duration, start pressure
SPL635 TBH2 NIBP simulation 2

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7 Test references
M - MTC-obligatory
S - STC-obligatory
C – for calbration
P – for plausibility check
N – measuring value / parameter according to standard

7.1 Temperature (M)


With the single test step SPL611 and the combination test steps SPL615-620
medical thermometers can be tested and calibrated. In addition instead of the
usual thermometric probe the TBH-400 is attached over the appropriate cable to
the equipment / module.
Thereupon the desired temperature is adjusted in the TBH-400 and compared by
the examiner with the shown value. In the PC operation as result of the
measurement „1” is returned, which means during appropriate evaluation that the
indicated temperature corresponds to the default.

• SPL611 temperature simulation (K, N)


- Temperature adjustable between 0-70 °C
- Read off value from the monitor

- Probe types:
Typ 0 : 100 Ohm at 25°C
Typ 1 : 300 Ohm at 25°C
Typ 2 : 1000 Ohm at 25°C
Typ 3 : 2252 Ohm at 25°C
Typ 4 : 3000 Ohm at 25°C

7.2 Invasive blood pressure (S)


With the single test steps SPL621-627 and the combination test steps SPL615-
620 invasive blood pressure devices can be tested and calibrated. In addition
instead of the suitable pressure absorber (transducer cable) the TBH-400 is
attached over the appropriate cable to the equipment / module.
The static pressure (SPL621) serves for the calibration / test of the pressure
indication. In addition over the service menu of the test object the pressure
indication is usually adjusted. The required static pressure is adjusted in the TBH-
400 and compared and / or corrected by the examiner with the shown value.
The output of the dynamic pressures (SPL622) and / or arrhythmia (SPL623)
serves for the concluding plausibility check. For this typical physiological pressure
processes are simulated. Newer monitors automatically recognize the simulated
pressure proces, if not the appropriate pressure can be adjusted first at the
object.
In the PC operation as result of the measurement „1” is returned “, which means
during appropriate evaluation that the indicated pressure / curve shape
corresponds to the default.

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• SPL621 / 625 IBP static (K, P)


- Pressure adjustable between 0-400 mmHg
- Read off value from the monitor

• SPL622 / 626 IBP dynamic (P)


- select the desired pressure curve
Typ 1 : ARP - aorta, radial artery pressure 120 / 80 mmHg
Typ 2 : AFP - aorta femoral pressure 130 / 70 mmHg
Typ 3 : CVP - central venous pressure 10 / 0 mmHg
Typ 4 : PAP - pulmonary aortic pressure 25 / 10 mmHg
Typ 5 : LVP - left ventricular pressure 10 / 0 mmHg
Typ 6 : LAP - left atrial pressure 5 / 0 mmHg
Typ 7 : RVP - right ventricular pressure 25 / 0 mmHg
Typ 8 : RAP - right atrial pressure 5 / 0 mmHg
Typ 9 : PAWP - pulmonary artery branch, Wegde position 10 / 0 mmHg
- Pulse rate adjustable between 30-150 bpm
- Read off value from the monitor

• SPL623 / 627 IBP arrhythmias (P)


- Select the desired pressure curve
Typ 11: squandered aorta 170 / 20 mmHg (with "0" pulses)
Typ 12: damped aorta 110 / 80 mmHg (with "0" pulses)
- Pulse rate adjustable between 30-150 bpm
- Read off value from the monitor

7.3 Non invasive blood pressure (M)


With the single test steps SPL631-635 not invasive blood pressure devices can
be tested and calibrated. In addition with the suitable connection hose the TBH-
400 is attached over the adapter block to the equipment / module.

Under the menu option measurements all measurements can be selected, which
are necessary for the MTK. With the manometer function (SPL631) the pressure
indication can be tested and calibrated; in addition usually the set up of the
service menu is necessary.
The tightness of the pneumatic system is tested by means of the leakage rate
measurement (SPL632); also individual cuffs. These are attached, like the
system, over the adapter block. For the adjustment of the cuff the cuff dummy
should be used.
By using the measurement of the decrease of pressure rate among other things
the function of the dump valve can be tested. General pressure decrease rate
measurements can likewise take place thereby.
Because the test steps described before deliver measured values as result, these
values can be transferred in PC operation The pressure value for SPL631
directly, the results from the test steps SPL632 and SPL634 only after manual
test.

NOTE: For this TBH-400 must be in the main menue !

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The simulation (SPL633/635) only serve for the concluding plausibility check.
Here it is checked whether the shown values lie in the dimension of the simulated
parameters.
Here in the PC operation as result of measurement „1” is returned, which means
during appropriate evaluation that the indicated pressure corresponds to the
default.

The following targets refer to the Standard EN 1060-3:1997.


• SPL631 NIBP manometer (K, N)
- Choose a manometer
- Pressure measurable between 0-750 mmHg
- Give pressure on the system, close any valves if necessary
- Measured value in display

• SPL632 NIBP leakage rate measurement (K, N)


- Adjustable time between 1-15 min, 5 min according to standard
- - Inflate to the desired starting pressure, at least 5 pressure stages,
(e.g., 50, 100, 150, 200, 250 mmHg)
- Wait 60s and then start measuring
- Measured value in display
- Pressure drop rate according to the standard max. 6 mmHg/min

• SPL633 / 635 NIBP simulation (P, N)


- If necessary set intensity (monitor dependent, see Section 4.3.2.2)
- If necessary, adjust pulse cycle
- Start the simulation on the
- Read measured values on the monitor; average of 3 measurements

• SPL634 NIBP pressure drop rate (K, N)


- Limit selectable of 0, 5, 10, 15 and 20 mmHg
Quick Exhaust: 15 mm Hg (adult) or 5 mmHg (NEO)
- Pump up to the required starting pressure:
Quick Exhaust: 260 mmHg (adult) or 150 mmHg (NEO)
- Wait 60 sec and then relieve the pressure and / or operate quick release
valve
- Measured value in display

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7.4 Cardiac output (S)


With the single test steps SPL641-643 devices for the determination of cardiac
outputs can be tested. In addition instead of the usual catheter cable the TBH-
400 is attached over the appropriate cable to the equipment / module.
By using the test steps SPL641 and SPL642 the injectate and blood temperature
can be tested. The temperature probes are simulated by the TBH-400.

Simulation (SPL643) serves for the plausibility check of the test object. In addition
different cardiac output volumes can be simulated.
With all test steps in the PC operation as result of measurement „1” is returned,
which means during appropriate evaluation that the indicated temperature and /
or the indicated cardiac output corresponds to the default.

• SPL641 CO injectate temperature (P)


- Injectate temperature is selectable between 4, 12 und 20 °C
- Starting signal releasable with F-key; not at all monitors
- Read off value from the monitor

• SPL642 CO body temperature (P)


- Body temperature firmly adjusted to 37 °C
- Read off value from the monitor

• SPL643 CO simulation (P)


- Confirm blood temperature
- Adjust injectate temperature
- Select cardiac output
- Starting; if necessary start monitor before
- Read off value from the monitor
- Measurement is repeatable how often you like, check monitor status

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8 Service and calibration

The measuring - and test devices quality, manufactured from S.P.L. Elektronik
Brieselang, is guarantied by a multi-level quality control - and quality assurances
in accordance to DIN EN ISO 9001. After final inspection and calibration each
device gets a examine plaque and a calibration certificate. The calibration is
enforced with standards, which are restorable to the standards of the Physical-
Technical Federal Institution.

In agreement with TÜV CERT, business-group TÜV Rheinland / Berlin-


Brandenburg, is recommended for normal, accordingly to the corresponding use
of the measuring and test devices form S.P.L. Elektronik Brieselang a annually
calibration interval.

The calibration includes a maintenance, update of the firmware, complete control


of the accuracy of measurements for of all test steps by control with one or
several reference-values and calibration. By an update of the firmware for
example, changes in standards, expansions of the function of the devices etc. are
automatically integrated. By the implemented inspection and calibration, the
validity is fixed by the implemented measurement list in the associated user
guide. The warranted characteristics for the PC-operation of the measuring - and
test devices of S.P.L. Elektronik are guaranteed through the offered or authorized
software-programs.

For cleaning, you should wipe off your device with a moist cloth, that is
impregnated with a mild detergent. It is important after that to rub your device dry.

Attention – Hint!

Before cleaning always pull of the power plugs, otherwise danger for life exists

Please take note in the use with the test system that it is despite of protected
measuring channel inputs a sensitive measuring instrument.

RoHS Directive:
The S.P.L. Elektronik hereby confirm that all components are delivered according
to the RoHS Directive (2002/95/EG) since 1. July 2006.

Waste disposal:
Through the used parts of the measuring - and test devices of the S.P.L.
Elektronik, etc. accumulators, Lithium batteries, and similar things, a professional
waste disposal is necessary. This can be done through S.P.L. Elektronik, ear
37506249, if demand is enforced.

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