Datex-Ohmeda S/5 M-COPSv Use and care manual

Datex-Ohmeda Cardiac Output Modules
S/5TM Cardiac Output and SvO2Module, M-COPSv (Rev. 01)
S/5TM Cardiac Output Module, M-COP (Rev. 03)
Technical Reference Manual Slot
All specifications are subject to change without notice.
Document No. 800 1012-1
June 2001
Datex-Ohmeda Inc.
3030 Ohmeda Drive
53707-7550 MADISON, WIS
USA
Tel. [phone], Fax [phone]
www.us.datex-ohmeda.com
Datex-Ohmeda Division,
Instrumentarium Corp.
P.O. Box 900, FIN-00031
DATEX-OHMEDA, FINLAND
Tel. [phone] Fax [phone]
www.datex-ohmeda.com
Instrumentarium Corp. All rights reserved.

Table of contents
Document No. 800 1012-1
i
TABLE OF CONTENTS
Cardiac Output Modules, M-COP and M-COPSv
TABLE OF CONTENTS i
TABLE OF FIGURES ii
Introduction 1
1 Specifications 2
1.1 General specifications ..............................................................................................................................2
1.2 Typical performance .................................................................................................................................2
1.2.1 C.O. .................................................................................................................................................2
1.2.2 SvO2................................................................................................................................................2
1.2.3 InvBP...............................................................................................................................................2
1.3 Technical specifications............................................................................................................................3
2 Functional Description 4
2.1 Measurement principle .............................................................................................................................4
2.1.1 Cardiac output and REF ....................................................................................................................4
2.1.2 SvO2measurement ..........................................................................................................................5
2.1.3 Invasive blood pressure measurement ..............................................................................................6
2.2 Main components.....................................................................................................................................6
2.2.1 COP board ........................................................................................................................................7
2.2.2 COPSv board..................................................................................................................................10
2.3 Connectors and signals...........................................................................................................................11
2.3.1 Module bus connector....................................................................................................................11
2.3.2 Front panel connectors ...................................................................................................................12
3 Service Procedures 14
3.1 General service information.....................................................................................................................14
3.2 Service check .........................................................................................................................................15
3.2.1 Recommended tools ......................................................................................................................15
3.3 Disassembly and reassembly..................................................................................................................20
3.4 Adjustments and calibrations..................................................................................................................20
3.4.1 Cardiac output calibration...............................................................................................................20
3.4.2 Invasive pressure calibration...........................................................................................................20
4 Troubleshooting 22
4.1 Troubleshooting charts............................................................................................................................22
4.1.1 Cardiac Output...............................................................................................................................22
4.1.2 SvO2..............................................................................................................................................22
4.1.3 InvBP.............................................................................................................................................23
4.2 Troubleshooting flowchart .......................................................................................................................24
5ServiceMenu 25
5.1 COP Menu ..............................................................................................................................................26
5.1.1 COP calibration menu.....................................................................................................................28
6 Spare Parts 29
6.1 Spare parts list .......................................................................................................................................29

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6.1.1 Cardiac Output Module, M-COP Rev. 00..........................................................................................29
6.1.2 Cardiac Output Module, M-COP Rev. 01..........................................................................................29
6.1.3 Cardiac Output Module, M-COP Rev. 02..........................................................................................30
6.1.4 Cardiac Output Module, M-COP Rev. 03..........................................................................................30
6.1.5 Cardiac Output and SvO2Module, M-COPSv Rev. 00 .......................................................................30
6.1.6 Cardiac Output and SvO2Module, M-COPSv Rev. 01 .......................................................................31
6.1.7 Front panel stickers for AS/3 modules (square buttons)...................................................................31
6.1.8 Front panel stickers for S/5 modules (round buttons).......................................................................31
7 Earlier Revisions 32
APPENDIX A 33
Service check form A-1
TABLE OF FIGURES
Figure 1 Cardiac Output Module, M-COP, and Cardiac Output and SvO2Module, M-COPSv .................................. 1
Figure 2 Cardiac output measurement curve....................................................................................................... 5
Figure 3 Front panels of Cardiac Output Modules, M-COP and M-COPSv.............................................................. 6
Figure 4 COPSv board block diagram, on COP board the SvO2section is excluded................................................ 8
Figure 5 Pressure transducer principle of operation............................................................................................. 8
Figure 6 Serial communication and opto isolation............................................................................................... 9
Figure 7 Cardiac Output Module troubleshooting flowchart................................................................................24
Figure 8 Module box and Cardiac Output Module, M-COP .................................................................................29
Figure 9 Cardiac Output and SvO2Module, M-COPSv........................................................................................30

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INTRODUCTION
This section provides information for the maintenance and service of Cardiac Output Modules, M-
COP and M-COPSv. Cardiac Output Modules, M-COP and M-COPSv are single width plug-in
modules designed for use with the S/5 monitors. Later in this manual modules can be called w/o
system name S/5.
Both modules provide
•Cardiac output (C.O.)
•Right ventricular ejection fraction (REF)
•Invasive blood pressure (InvBP) measurement
Additionally, the COPSv module provides venous oxygen saturation (SvO2) measurement.
NOTE: Do not use identical modules in the same monitor simultaneously.These modules are
considered as identical and would cause communication errors if used in the same system.
Figure 1 Cardiac Output Module, M-COP, and Cardiac Output and SvO2Module, M-
COPSv

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1SPECIFICATIONS
1.1 General specifications
Module size (W ×D ×H) 37 ×180 ×112 mm / 1.5 ×7.1 ×4.4 in
Module weight 0.35 kg / 0.8 lbs
Power consumption, M-COP Approximately 3.5 W
Power consumption, M-COPSv Approximately 5 W
1.2 Typical performance
1.2.1 C.O.
Measurement range 0.1...20 l/min
Display resolution 0.01 l/min
Repeatability ±2 % or ±0.02 l/min whichever is greater
(measured from electrically generated flow curves)
Max. change in blood temp 2.99 °C
Injectate temp range (with Edward's compatible probes)
0...25.5 °C ±0.3 °C
25.5...27.0 °C ±0.5 °C
Blood temp range (with Edward's compatible catheters)
17.5...30.9 °C ±0.5°C
31.0...43.0 °C ±0.3°C
Protection against electric shock type CF defibrillation proof
REF
Repeatability ±2 %
(Measuring range 10-60 %)
1.2.2 SvO2
Accuracy ±2 %
(Measuring range 30-95 %)
Equal to standard deviation when using in-vivo calibration.
1.2.3 InvBP
Measurement range -40...+320 mmHg
Zero adjustment range ±150 mmHg
Calibration range ±20 %

Cardiac Output Modules, M-COP and M-COPSv
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Scales Upper limit is adjustable between 10 and 300
mmHg in steps of 10. Lower limit is 10 % of selected
upper limit below zero.
Sweep speed 12.5, 25, 50 mm/s
DIGITAL DISPLAY
Range -40...+320 mmHg
Resolution ±1 mmHg
WAVEFORM DISPLAY
Range -30...+300 mmHg
PULSE RATE
Measurement range 30...250 bpm
Resolution 1 bpm
Accuracy ±5 % or ±5 bpm whichever is greater
Respiration artifact rejection
1.3 Technical specifications
The digital display is averaged over 5 seconds and updated at 5 second intervals.
Accuracy ±5 % or ±2 mmHg, whichever is greater
Transducer and 5 µV/V/mmHg, 5 VDC
input sensitivity 20 mA max current
Nonlinearity <1 %, 0 to 200 mmHg
<2 %, -40 to 0 and 200 to 320 mmHg
Filter 0...22 Hz (-3 dB),
adjustable upper limit 4...22 Hz
Zero set accuracy ±1 mmHg
Calibration resolution ±1 mmHg
Zero time < 15 sec
Protection against electric shock type CF defibrillation proof
NOTE: The accuracy of the measurement may be different from the specified accuracy, depending
on the transducer/probe used. Please check the transducer/probe specification.

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2FUNCTIONAL DESCRIPTION
2.1 Measurement principle
2.1.1 Cardiac output and REF
Cardiac output measurement is made using the principle of thermodilution. During measurement
the catheter lies in the heart, with an injection port in the right atrium (RA) and a thermistor, which
is to monitor blood temperature, in the pulmonary artery (PA). A small, known amount of thermal
indicator is injected into the RA and is mixed with the blood on its way to the PA. The catheter
thermistor measures the decrease in blood temperature as the blood flows past the thermistor in
the PA.
The information is stored in the module and the cardiac output is calculated from the area beneath
the time-temperature Cardiac Output Measurement Curve, as shown in figure 2.
The area under the time-temperature curve is inversely proportional to the flow rate which
corresponds to cardiac output.
The cardiac output is calculated from the equation:
C.O.= (1.08 CT 60 Vi(TB-Ti))/(TBdt + C)
where:
C.O. = cardiac output in liters/minute
1.08 = factor comparing the density and specific heat of 5% dextrose solution in water to
those of blood.
CT= correction factor for the injectate temperature rise as it passes through the
catheter and its dead space
60 = seconds/minute
Vi= injectate volume in liters
TB= baseline blood temperature (°C)
Ti = injectate temperature
TBdt = area under time-temperature curve between time o and x, where x is the
time when the curve has dropped to 30% of its peak value.
C = area beneath time-temperature curve between x and the end of the
curve.

Cardiac Output Modules, M-COP and M-COPSv
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80% 30%
end of meas.
t
-T
m.s. Time
start of meas.
80%
30%
100%
0%
area C
area A
Temperature change in blood [
%
Figure 2 Cardiac output measurement curve
A = area derived by integration of the time-temperature curve
C = area beneath the time-temperature curve between t30% and end of the curve. Computation
based on an exponential fit to the curve between t80% of the peak and t30%.
REF (right ventricular ejection fraction) measurement is a part of the time-temperature
(thermodilution) cardiac output measurement. Ejection fraction is determined using an exponential
technique by synchronizing sensed R-waves with points of temperature changes on the time-
temperature curve. Once ejection fraction, cardiac output, and heart rate are known, right
ventricular volumes may be calculated. The measurement requires a Baxter-Edwards fast response
thermistor catheter and an ECG module to synchronize R-wave detection to the time-temperature
curves.
2.1.2 SvO2measurement
The COPSv module measures SvO2when coupled with a Baxter-Edwards OM-2E optical module
and a Swan-Ganz oximetry catheter. To measure SvO2, the system utilizes a spectrophotometric
technique involving the use of light emitting diodes (LEDs) that produce red (660 nm) and infrared
(810 nm) light. The light is transmitted to the blood through a single plastic optical fiber in the
oximetry catheter and reflected back through a separate optical fiber to a photodetector in the
optical module. The light is electrically transmitted to the COPSv module and analyzed to
determine SvO2.
The oximetry portion of the system measures SvO2in the pulmonary artery by detecting color
changes in the red blood cells. When pulses of red and infrared light are transmitted through the
oximetry catheter, the light is reflected from the red blood cells and transmitted back through the
catheter to the optical module. The amount of light reflected at each wavelength depends primarily
on the color of the blood and the number of red blood cells. Since the number of red blood cells in
the blood affects the amount of reflected light, the differences are compensated for when the
patient’s total hemoglobin value is entered. The optical module stores and transfers SvO2
calibration data. SvO2values can be affected by the presence of methemeglobin or
carboxyhemoglobin which imitate the absorption characteristics of HbO2. Large concentrations of
methemeglobin or carboxyhemoglobin could then cause a falsely elevated SvO2. In cases where
dysfunctional hemoglobins are suspected, SvO2should be interpreted with caution.

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2.1.3 Invasive blood pressure measurement
To measure invasive blood pressure, a catheter is inserted into an artery or vein. The invasive
pressure setup, consisting of connecting tubing, pressure transducer, an intravenous bag of normal
saline all connected together by stopcocks, is attached to the catheter. The pressure transducer is
placed at the same level with the heart, and electrically zeroed.
The pressure transducer is a piezo-resistive device that converts the pressure signal to a voltage.
The monitor interprets the voltage signal so that blood pressure data and blood pressure
waveforms can be displayed.
2.2 Main components
The Cardiac Output Module, M-COP consist of a COP circuit board and two input boards - a CO
input board and a P input board, attached to the front panel.
The Cardiac Output and SvO2Module,M-COPSv, consist of a COPSv circuit board and three input
boards - a CO input board, a SvO2input board and a P input board, attached to the front panel.
The front panels are shown in figure 3.
P 4
1
2
3
4
5
C.O.
P4
C . O .
SvO
2
6
M-COP M-COPSv
Figure 3 Front panels of Cardiac Output Modules, M-COP and M-COPSv
(1) Key for pressure zeroing (Zero P4)
(2) Key for cardiac output measurement (Start C.O.)
(3) Connector for invasive blood pressure measurement
(4) Connector for C.O. self test
(5) Connector for C.O. measurement
(6) Connector for SvO2measurement

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2.2.1 COP board
The COP board consists of the following functional sections.
•Processor
•Cardiac output measurement
•Cardiac output self test
•Invasive blood pressure measurement
•Serial communication
•Isolation
•Power supply
Processor section
The microprocessor uses the Intel 80C196KC-16 CPU which includes three A/D converters and a
UART. The microprocessor uses external memories, an 8-bit data bus, a 16 MHz oscillator, and a
watchdog timer. The three A/D-converters within the CPU convert the analog input signals to
digital. The internal UART communicates and transfers data between the module and the CPU
board in the monitor.
Cardiac output measurement section
The catheter and the probe contain an NTC resistor that reacts to temperature change.
The temperature dependent voltage across the NTC resistor is amplified and an offset value is
added to it. The resultant signal is then regulated into a ±5 V range by voltage slicing and sent to an
A/D converter.
Because the temperature measurements are calibrated digitally and non-linearity of
catheter/probe is compensated by software, ambient temperature change after calibration is the
only factor that may influence the measurement.
Cardiac output self test
The Cardiac Output Module, M-COP contains a C.O. Self Test connector.
When the cable is connected to the C.O. Self Test connector, the microprocessor starts the test
program automatically. First, the microprocessor measures 30 °C, then it activates test circuits
and measures 37 °C and 41 °C.
If the values are not correct ‘Cable fault’ is displayed and there is a fault is either in the module or in
the catheter connecting cable.

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RS485
DRIVER
FOR
DATA
RS485
DRIVER
FOR
MODULE
RESET
POWER
NON-
ISOLATION
SECTION
POWER
ISOLATION
SECTION
POWER
RESET
ISOLATION
TRANS-
FORMER
NON-
VOLATILE
MEMORY
MICROPROCESSOR
RAM internal 256
external 16K
EPROM 48K
RS COMMUNICATION
OPTO
ISOLATION
C.O.
MEASURING
UNIT
P4 INV
PRESSURE
MEASURING
UNIT
FRONT
PANEL
KEYS
AD-
CONVERTER
8 chn
12 bit
Reset
Module bus data
Serial device
communication
C.O.
control
C.O.
AD
Press AD
Module
data
Module
reset
Power for
communication Power for
module
PATIENT ISOLATION
SvO2
MEASURI NG
UNIT
To optical module
SvO2 AD
OM-2 control
Figure 4 COPSv board block diagram, on COP board the SvO2section is excluded
Invasive blood pressure measurement section
Input
Filter
Instrumentation
amplifier
to AD converter
Pressure
transducer
Uin
Uout G
Figure 5 Pressure transducer principle of operation
An isolated +5 V supply is connected to the input of the pressure transducer bridge circuit. From
the bridge circuit output a differential voltage, which depends on blood pressure and input supply
voltage, is calculated using the following formula:

Cardiac Output Modules, M-COP and M-COPSv
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Uout = Uin x Pressure x 5 V, where Uin = 5 V ÞUout = 25 V x Pressure [mmHg]
Pressure amplification is performed by the instrumentation amplifier. The gain of the amplifier is
set so that the level of the signal transferred to the A/D converter stays within the measurement
range even when there are circumstantial offsets or offsets caused by the pressure transducer. The
input filter before the amplifier attenuates high frequency disturbances.
A FET switch cuts the measurement current and detects the existence of the pressure transducer.
The existence of the pressure transducer is also checked digitally by a jumper next to the
connector.
Serial communication
Serial communication between the Cardiac Output Module and the Central Unit Frame is via an
RS485 type bus. The communication bus drivers are powered from the Module Bus. The module
isolation section is powered (+5 V) from the isolated power supply.
The communication drivers are controlled by a Reset signal such that when the Reset is active the
drivers do not transfer data.
In addition to the RS485 reset there is a logic power-up reset, which holds for approximately 500
ms regardless of the state of the RS485 reset. A time constant determines the power-up reset time.
The power-up reset also prevents the module from sending data to the Module Bus. The data
transmission rate is 500 kbps.
RS485
Driver
RS485
Driver
Reset
Data
NData
Reset in
NReset in
Send data
Receive data
send/receive
Receive data
Send data
send/receive
Reset
to module prosessor
to central unit (module bus)
Opto isolation
Patient Isolation
Figure 6 Serial communication and opto isolation
Isolation section
There are two opto isolators, one for data and one for the reset signal. Signals are processed on
logical high-low levels even though the output of the opto isolators in the isolation section are
analog signals.
The reset line is an open collector type, with a pull-up resistor so that the microprocessor is able to
use its internal watchdog function.

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Power supply section
The module isolated power supply is developed from the +15 Vdirty (non isolated) supply from the
Central Unit power supply.
The isolated power supply is a switched-mode circuit, where an FET switch is controlled by an
oscillator using a bipolar timer. The frequency of the oscillator is approximately 30 kHz, with a
pulse ratio of 50%; switching of the FET is slow to suppress spurious interference. A special
isolation pulse transformer is used in the circuit. The transformer secondary circuit uses normal
linear regulators except for +5 V which uses a low drop type linear regulator.
2.2.2 COPSv board
The COPSv board consists of the same functional sections as the COP board, except for the cardiac
output self test section. Additionally, the COPSv board consists of the SvO2measurement section.
SvO2measurement section
The SvO2algorithm is a part of the COPSv module software. The algorithm consists of five different
parts; initialization, calibrations, signal processing and SvO2calculation, automatic gain control,
and signal quality analysis.
Initialization
When the optical module is connected to the COPSv module, a number of start-up procedures are
performed prior to normal operation. These procedures include transfer of calibration factors from
the optical module to the COPSv module and initialization of LED currents.
Calibration
The system is calibrated according to either in-vitro or in-vivo calibration. In-vitro calibration is
performed before the oximetry catheter is removed from the package with the catheter tip still
inside the calibration cup. The resulting calibration factor is calculated on the basis of the
measured ratio of red and infrared signals and the ideal ratio for the calibration cup. In-vivo
calibration is performed when the catheter is inserted into the patient’s pulmonary artery. The
resulting calibration factor is based on the measured ratio of red and infrared signal and the Hgb
and SvO2values measured in a laboratory. If the calibration is skipped, the result of an old
calibration is used instead and the “Not calibrated” message is displayed in the SvO2number field.
Signal processing and SvO2calculation
The reflected red and infrared signals transferred from the optical module to the COPSv module are
filtered, and SvO2is calculated on the basis of the ratio of the two signals.
Automatic gain control
The intensity of the red and infrared signals can be amplified by four different gains. The gain is
selected automatically to achieve optimal signal levels.
Signal quality
The reflected red and infrared signals are checked for wall contact artifacts, pulsatility and intensity
shifts. An index is calculated to indicate the signal quality. 0 indicates a normal signal, 1 indicates
an intermediate signal, 2 indicates a poor signal, and 3 indicates an unacceptable signal. Please
refer to the service menu section for more information.

Cardiac Output Modules, M-COP and M-COPSv
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2.3 Connectors and signals
2.3.1 Module bus connector
Pin I/O Signal
13
1
14
25
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
I
I
I
I
I/O
I/O
-
I
I
O
I
O
-
I
I
I
O
I
O
-
-
-
-
I
I
RESET_RS485*
-15 VDC*
+15 VDIRTY*
+15 VDC*
-DATA_RS485*
DATA_RS485*
Ground & Shield*
-RESET_RS485*
CTSB
RTSB
RXDB
TXDB
Ground & Shield*
+32 VDIRTY
GroundDIRTY*
CTSC
RTSC
RXDC
TXDC
ON/STANDBY
BIT0IN
RXDD_RS232
TXDD_RS232
+5 VDC*
+5 VDC*
*Used in the M-COP module

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2.3.2 Front panel connectors
Invasive blood pressure connector (P4)
Pin Signal
6
8
9
0
1
2
4
5
7
3
1
2
3
4
5
6
7
8
9
0
Pressure 4 +
Pressure 4 -
Polarization - (ground)
Polarization +
Not connected
Not connected
Not connected
Not connected
Ground
Cable detection
Cardiac output connector (C.O.)
Pin Signal
1
2
34
5
6
8
7
10
11
12
13
14
15
16
17
9
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
BAB
THB
BAC
Not connected
Shield
Not connected
THD
THA
THC
BAA
Not connected
Not connected
Not connected
FL
Not connected
Not connected
Not connected
C.O. Self Test connector (C.O. Test)
Pin Signal
1
2
3
4
1
2
3
4
CTC
CTA
CTB
CTD

Cardiac Output Modules, M-COP and M-COPSv
Document No. 8001012-1
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SvO2connector (SvO2)
Pin Signal
1
2
3
4
5
6
87
10
11
12
13
14
15
16
17
9
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
IR_CATHODE
CE
SK
DATA_OUT
CHASSIS_GND
SVO2_GND
HEATER_RTN
REMOTE_OUT
+V_OPT
TEMP_SENSOR
HEATER_HI
LOCAL_OUT
REF_RTN
LED_ANODE
RED_CATHODE
DATA_IN
-V_OPT

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3SERVICE PROCEDURES
3.1 General service information
Field service of the M-COP and M-COPSv modules is limited to replacing faulty mechanical parts.
The COP board and the COPSv board cannot be replaced, and all calibrations can only be done at
the factory.
Datex-Ohmeda is always available for service advice. Please provide the unit serial number, full
type designation, and a detailed description of the fault.
CAUTION Only trained personnel with the appropriate tools and equipment should perform
the tests and repairs outlined in this section. Unauthorized service may void
warranty of the unit.

Cardiac Output Modules, M-COP and M-COPSv
Document No. 8001012-1
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3.2 Service check
These instructions include complete procedures for a service check. The service check is
recommended to be performed after any service repair. However, the service check procedures can
also be used for determining possible failures.
The procedures should be performed in ascending order.
The instructions include a check form (Appendix A) which should be filled in when performing the
procedures.
The mark ?in the instructions means that the check form should be signed after performing
the procedure.
The procedures are designed for monitors with S/5 monitor software of revision 01. However, most
of the procedures also apply to monitors, which contain some other monitor software
type/revision.
3.2.1 Recommended tools
Tool Order No. Notes
Patient simulator
SvO2simulator 890121
Pressure manometer
InvBP transducer
Catheter connecting cable
Screwdriver
All modules
•Detach the module box by removing the two screws from the back of the module. Be careful
with the loose latch and spring locking pin.
1. Check internal parts:
•screws are tightened properly
•cables are connected properly
•all socket mounted IC’s are inserted properly
•EMC covers are attached properly
•there are no loose objects inside the module
?
2. Check external parts:

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•the front cover and the front panel sticker are intact
•all connectors are intact and are attached properly
•the module box, latch and spring locking pin are intact
?
•Reattach the module box and check that the latch moves properly.
•Turn the monitor on and wait until the monitoring screen appears.
•Configure the monitor screen so that all the required parameters are shown, for example :
Monitor Setup - Screen 1 Setup - Waveform Fields - Field 4 - P4
Digit Fields - Field 4 - SvO2
•Preset the C.O., SvO2and InvBP measurement settings:
Others - C.O. View - C.O. Setup - Scale - 1.0 °C
Injectate Volume - 10 ml
Measurement Mode - SET
SvO2- Update Hgb - 115 g/l
Invasive Pressures - P4 Setup - Label - PA
3. Plug in the module. Check that it goes in smoothly and locks up properly.
?
4. Check that the module is recognized by entering the C.O. View menu:
Others - C.O. View
Check that the message “No Catheter” is shown in the middle of the menu and the message
“No cable” in the digit field for SvO2, if it is an M-COPSv module.
?
5. Enter the service menu:
Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8)
Take down the information regarding COP software by selecting SCROLL VERS and turning
the ComWheel.
?
6. Enter the COP module service menu:
Parameters - COP
Check that the “Timeouts”, “Bad checksums” and “Bad c-s by mod” values are not
increasing faster than by 50 per second. Check that the module memories have passed the
internal memory test, i.e. “RAM”, “ROM” and “EEPROM” all show OK.