RADIOMETER TCM3 User manual

TCM3
and
TCM30
Transcutaneous
Monitoring
Systems
Service
Manual
983-578 Printed by RADIOMETER Copenhagen Denmark 199808-1
RADIOMETER EŞ
GOPENHAGEN BiZ
© Radiometer A/S, Denmark, All Rights Reserved

Pa,
A
TCM3 and TCM30 Service Manual
Overview
Introduction
Contents
n.i.. anne na
TCM3 and TCM30 Service Manual
This service
manual is to be used as a reference when servicing the TCM3 and
TCM30 systems including the various accessories such as recorders, battery
cassettes, and mains adapters.
This service manual contains the following topics.
Topic See Chapter
Introduction ...................rirreerer ire cereerene zena niaea cere nionieneonenzerzicorenieniereneonevencenione 1
NAAA 2
TCM30 ssese sensssssnsssnsessssnnnnsterssnsevnnrnnvsrrsrsssssressrrosssssseennnssensssennsseeasesns 3
ТССЗ.......... линии ииииитии ить ионьнионииитииитиииииититеитииилиииитетеиеттитьтиттититинтттивиний 4
TCR3 and REC concoccocconacaononornnnroroonnonacnororonconar encuen oncororacoroonorconeo rosso renerencaresaceracecorono 5
Vo e 10) e ONNO 6
Continued on next page
Front 1

TCM3 and 30 Service Manual
1.
Introduction
Overview
Introduction
This
chapter
gives
an
introduction
to
the
TCM3
and
TCM30
monitors.
It
also
gives
an
overview
of
the
changes
and
additions
to
the
manual
as
the
front
page
of
©
all
Service
Notes
are
to
be
inserted
here.
Contents
This
chapter
contains
the
following
topics.
Topic
See
Page
AS
merreemmamereamemrsrsemeremmmesemarssenrasmaraaama
rasta
anan
1
Introduction
to
the
Systems...
Service Notes
Revised
97.06.23
-
Introduction
1-1

ーー
TCM3 and TCM30 Service Manual
Service Notes
1. Introduction
Update ofthe In the event of important changes in procedures or components, the Service
TCM3/30 Manual will be updated by means of Service Notes. Service Notes consists of a
Service Manual front page giving an overview of the changes and copies of revised pages.
The front page should be inserted in chronogical order after this sheet whereas the.
revised pages should be inserted into the Service Manual instead of the existing
ones.
Inserted Service The following Service Notes have already been inserted into the manual.
Notes
Part Number Subject Issued
917-140 TCM3 electrode socket 8607*
917-141 TCM3 Main PCB 8608*
917-148 TCR3 paper run out 8701
917-156 TCR3 printing voltage 8705
917-157 TCC3 gas inlet module 8707
917-167 TCM3 revision 8803
917-186 Service Manual corrections 8812
917-201 Service Manual updating - | 8911
917-213 New combined TC-electrode | 9003*
917-238 Service Manual updating 9108
917-296 Electrode performance check | 9401
917-302 Service Manual updating 9405
917-334 CE labelling - New parts 9601
N/A Introduction of TCM30 9706
917-352 Service Manual updating 199808-1
199808-1
1-3

SERVICE
NOTES
fom
Radiometer
Medical
A/S
917
-
334
Analyzer:
TCM3
January
3,
1995
Subject
CE
Labeling
-
New
Parts
Background
In
connection
with
the
CE
labeling
of
the
TCM3
system,
some
changes
to
the
Implementation
Changes
Procedures
hardware
have
been
implemented
to
improve
the
EMC
(Electro
Magnetic
Compatibitity).
These
changes
are
implemented
in:
TCM3s
of
Run
148
onwards,
REC3s
of
Run
69
onwards,
and
E5280
of
Lot
LR
#
onwards.
Please
note
that
TCM3s
of
Runs
146
and
147
include
all
the
changes
for
compliance
with
the
CE
labeling
(only
the
CE
label
itself
is
missing)
No
hardware
changes
are
required
for
the
TCC3
and
the
BAT3.
They
are
CE
labeled
as
of
Runs
102
and
17
respectively
BAT3
R0015N005
is
also
CE
labeled.
The
following
new
part
has
been
introduced:
902-428
Analog
PCB
for
the
TCM
(revised
layout)
The following three parts have been modified:
901-832
Power
Supply
PCB
for
the
TCM3
(decoupling
capacitors
added)
901-806
Printer
Control
PCB
for
the
REC
(ground
strap
changed)
945-377
ES280
tc
pOy/pCO,
Electrode
(decoupling
capacitors
added)
_
Modified
PCBs
which
retain
the
original
part
numbers
are
marked
with
a
round
blue label on the box.
On
new
E5280
electrodes,
one
haif
of
the
type
marker
is
green
and
the
other
half
is
white
(both
halves
of
the
earlier
type
marker
are
green).
The
new
and
moditied
PCBs
MUST
be
used
for
servicing
TCM3s
of
Run
148
onwards
and
RECs
of
Run
69
onwards
to
maintain
compliance
with
the
CE
labeling.
The
new
parts
should
also
be
used
for
servicing
TCM3s
of
Runs
146
and
147.
Earlier
analyzers
may
be
serviced
with
the
original
parts.
IMPORTANT:
ATCM3
system
will
comply
with
the
CE
labeling
only
when
ALL
of
its
components
(TCM3,
REC,
and
E5280)
are
of
the
CE
labeled
version.
RADIOMETER 서게
COPENHAGEN B=

Service Notes
Service Notes for TCM3 and TCM30 Service Manual
Introduction
Documentation
Issue
The service manual has been updated in the following respects:
® A sheet which may be used for documenting the results from an Electrode
Performance Check has been included in the appropriate sections.
The procedure and the documentation of results is to be carried out in
connection with a service action which may affect measuring performance.
In the Checkout and Adjustment sections information about where the monitor
is to be dismantled has been included.
e A number of typographical errors have been corrected.
Please replace the following existing sheets with the ones supplied with this
Service Note.
— Inner front page
— Pages 1-3, Service Notes
— Section 2, entire section (text only)
— Section 3, entire section
Finally the following diagrams should be inserted at the end of section 2 (behind
the existing diagrams):
28622-A4
7422-A3
7427-A3
28623-A4 and
28455-A4
917-352, 199808-1 RADIOMETER Bag
COPENHAGENS

TCM3
Introduction
Contents
199808-1
< IVD
2. TCM3
This
part
gives
detailed
information
about
the
function
and
servicing
of
the
TCM3
monitor.
This chapter contains the following topics.
General Information
Test Procedures
Dismantling and Replacements
Spare Parts List

2. TCM3 TCM3 and TCM30 Service Manual
2-2 199808-1

USO AI IVY IG VIE IICA
Overview
Introduction
Contents
199808-1
e. TUNIS
General Information
This
section
gives
some
general
information
about
the
TCM3
monitor.
This section contains the following topics.
General
Information...
μμ
2-4
2-3

2. TCM3
TCM3 and TCM30 Service Manual
General Information
Introduction The TCM3 combined pOypCO, monitor is intended for transcutaneous
monitoring of pO/pCO, via a heated electrode mounted on the skin. The
measurement data are presented on the LED display and printed by the optional
TCR3/REC digital recorder via the serial data output socket.
The monitor is fitted with a rechargeable NiCd battery. When fully charged, its
capacity correspond to approximately three hours of operation.
A mains adapter charges the NiCd battery and supplies the monitor
simultaneously. A discharged NiCd battery is recharged in approximately 16 hours
when the monitor is switched on during charging. If not, 8 hours is required for a
full recharge.
The serial data or analog outputs are functional only if the monitor is powered
from the mains.
Tf an optional battery cassette is connected to the monitor, its total capacity
corresponds to approximately 11 hours of operation.
TCM3 from R22 onwards include the following features:
+ 4 channel analog output (pO,, pCO,, heat/temperature, alarm)
® Trend memory for up to 12 hours patient-data collection
» The optional digital recorder REC is powered from TCM3
The monitor cabinet is designed for attaching the optional recorder or battery
cassette to the monitor
TCM3 below R22 does not include the trend memory feature nor the
recorder/battery cassette attaching feature.
em heir analog. output has-only 2 channels.(pO,.and pCO,) and the monitor is
Software
2-4
powered from the optional digital recorder TCR3.
The monitor is microcomputer controlled, and the software primarily takes care of
the following functions:
Measurement of the primary electrode parameters and conversion into
pO/pCO, (mmHg or kPa)
® Measurement of the electrode temperature and heat control
e Data transfer to the display and the serial data/analog outputs.
+ Activation of the acoustic alarm where the pOy/pCO,, heat or temperature
parameter limits are exceeded
« Front panel keyboard control
« Automatic calibration and electrode check
Continued on next page
199808-1

VMS
ana
FUMSU
Service
manual
2.
TCM3
General Information, Continued
Hardware
Analog PCB
199808-1
The
electronics
are
mounted
on
four
PCBs.
Please
refer
to
the
block
diagram
at
the
end
of
the
TCM3
part.
Monitor Drawing
TCM3 below R22 | 3759-A2, revision O
TCM3 from R22 3759-A2, revision 1
This
board
includes
the
electrode
input
circuits,
the
A/D
converters,
the
patient
safety
barrier
components
and
the
charging
circuit
for
the
NiCd
battery.
Signals
from
the
electrode
and
the
electrode
amplifiers
mounted
in
the
electrode
plug,
that
is,
the
pO2,
pCO,
and
thermistor
signals,
are
converted
into
pulse
signals
by
the
two
A/D
converters.
The
pulse
duty
cycle
represents
the
measured
value.
One
of
the
A/D
converters
is
common
to
all
parameters
via
the
input
multiplexer.
The
other
is
used
in
order
to
increase
the
speed
and
security
of
the
electrode
temperature
regulation
system.
The
electrode
temperature
is
measured
by
means
of
a
thermistor
which
is
part
of
a
temperature
resistor
bridge.
The
heat
power
is
measured
across
the
resistor
R,
and
the
microcomputer
is
informed
via
the
input
multiplexer
and
A/D
converter
1.
The
NiCd
battery
charging
circuit
adjusts
the
charging
current
according
to
the
monitor
consumption.
The
galvanic
separation
between
the
power
supply
board
and
the
rest
of
the
monitor
is
achieved
by
using
a
switching
power
supply,
and
opto-couplers
for
the
input/output
signals.
TCM3
below
R22
include
two
opto-couplers.
One
for
digital/analog
output
and
one
for
digital
input.
ТСМЗ
from
R22
onwards
includes
five
opto-couplers.
Two
for
the
input/output,
and
two
for
automatic
power
supply
regulation.
The
fifth
opto-coupler
is
transferring
on/off
information
from
the
on/off
switch
to
a
switching
circuit,
which
prevents
the
optional
battery
cassette
from
being
discharged,
if
it is not
dismounted
after
use.
Continued on next page
2-5

2. TCM3
TCM3 and TCM30 Service Manual
General Information, Continued
Main PCB
2-6
Includes
the
microcomputer
system,
the
parallel
and
serial
input/output
ports,
the
electrode
heating
supply,
the
5
V
supply
and
the
LED
display
control
system.
The
two
parallel
ports
interface
the
microcomputer
with
the
analog
signals,
the
front
panel
keys
and
the
heat
control.
TCM3
below R22
include
a
DIP
switch
for
setting
some
user-selectable
options.
Switch Function
ON: mmHg, OFF: kPa
2 ON: In-vivo cal. (not approved by the FDA)
3-7 Not used
8
ON:
Demonstration
mode.
The
time-out
functions
in
the
Setup and AUX programs are cancelled.
TCM3
of
R22
onwards
do
not
include
the
DIP
switch.
Instead,
the
options
are
selected
via the
front
panel
keys.
A
demonstration
mode
is
called
by
switching
on
the
monitor
while
pressing
the
ALARM-OFF
key
and
the
A
key
simultaneously.
In
this
mode,
the
time
out
in
the
Setup
and
AUX
programs,
are
cancelled
for
30
minutes
after
power
on.
To get back to normal, switch off and on the monitor.
Selection
between
mmHg
and
kPa,
and
in-vivo
cal,
are
performed
while
the
. monitor is in service mode step 4. -
Switch
on
the
monitor
while
the
ALARM
OFF
key
and
the
SET
key
are
pressed
simultaneously.
The
software
version
No.
is
displayed
in
the
AUX
display.
Wait
until
the
software
No.
stops
flashing
and
select
step
4
(0:04
in
the
AUX
display)
by
the
ALARM-OFF
key.
Now,
selection
between
mmHg
and
kPa
are
performed
by
the
A
or
W
keys.
kPa
“mode”
is indicated
by
decimal
points
in
the
pO,
and
pCO,
displays.
Selection
between
in-vivo
cal.
and
not
in-vivo
cal.
is
performed
by
the
CAL
key.
In-vivo
cal.
“mode”
is
indicated
by
the
AUX
display.
The
UART
controls
the
serial
input/output
signals
for
the
serial
data
interface.
The
output
signal
is gated
with
the
analog
control
signal
from
Port
1.
The
heat
supply
is
derived
via
a
D/A
converter
and
a
switching
power
supply.
It
is
controlled
by the
heat-off
signal
and
the
max.
temperature
monitoring
circuit,
the
so-called
“watch-dog”
circuit,
which disables
the
heat
in
the
case of
a
software
error.
The Main PCB includes a power supply monitoring system for activating the BAT
light-bar or resetting the monitor.
Continued on next page
199808-1

FCMS
and
1CM3U
Service
Manual
2.
TCM3
General Information, Continued
Main PCB
(continued)
Display PCB
Power Supply
199808-1
If
the
monitor
is
powered
from
the
built-in
NiCd
battery
only,
the
light-bar
is
activated
via
comparator
1,
indicating
that
the
function
time
of
the
Monitor
is
limited
to
approximately
3
hours
on
a
fully
charged
battery.
The
heat
supply
circuit
has
a
battery-low
terminal
which
is
activated
if
the
NiCd
battery
voltage
drops
below
7.0
V.
This
causes
the
BAT
light
bar
to
flash,
indicating
that
the
function
time
now
is
limited
to
approximately
10
minutes.
If
the
voltage
drops
below
6.5
V,
the
microcomputer
and
its
peripherals
will
be
reset.
The
microcomputer
system
consists
of
the
8-bit
CMOS
processor
NSC
800,
the
EPROM
(program
memory),
the
RAM
(data
memory)
and
the
input/output
peripherals
already
mentioned.
The
system
has
a
multiplexed
bus
structure
where
the
low
order
part
of
the
address
bus
is
shared
with
the
data
bus.
The
display
is
multiplexed
and
the
7-segment
display
data
are
latched
from
the
data-bus.
Includes
the
LED
display,
the
audio
transducer
for
the
acoustic
alarm,
the
electrode
holder
micro-switch
and
the
5
front
panel
keys.
If
the
mains
adapter
is
removed
from
the
monitor,
the
display
light
is
reduced.
This
reduces
the
power
consumption
and
thus
prolongs
the
function
time
of
the
monitor.
The
circuits
of
this
PCB
are
galvanic
isolated
from
the
rest
of
the
monitor
by
means
of
the
transformer
and
opto-couplers
on
the
Analog
PCB.
It
includes
a
switching
regulator
power
supply
system,
3
linear
DC
regulators
and
a
communication
circuit
for
the
analog
output
and
serial
data
input/output.
The
switching
regulator
has
a
combined
current
limiter/battery
control
circuit
which
disables
the
regulator
output
if
the
battery
voltage
decreases
below
6.2
volts.
Continued on next page
2-7

2. TCM3 TCM3 and TCM30 Service Manual
General Information, Continued
Patient Safety TCM3 is designed to comply with the IEC safety standards for medical equipment.
Any external device connected to the monitor, such as mains adapters, recorders,
computers etc., are galvanic isolated from the patient circuits.
The isolation is achieved by means of opto-couplers and a switching transformer. *
The “patient-side” of this barrier thus includes the Analog PCB, the Main PCB,
the Display PCB and the NiCd battery.
Each individual monitor is exposed to a final safety test before it leaves
RADIOMETER for shipment.
This safety test includes a patient barrier isolation test by a high voltage generator,
and a leakage current test.
The monitors are fitted with a comprehensive safety system to minimise the
probability of loosing electrode heat control.
e The electrode power consumption is continuously monitored. If it exceeds 600
mW for more than two minutes, the heating will be switched off and Error 5
will be displayed.
e Ifthe electrode temperature increases to more than 45.6 °C, the heating will be
switched off, and Error 10 is displayed. Further, the heat regulator will be
disabled.
e Ifa temperature difference of more than 0.6 °C is detected between the two
thermistors (combined electrodes E5277 and E5280) the heating will be
switched off and Error 11 is displayed.
e Ifa software error occurs, a monitoring circuit, the so-called “watchdog”
circuit, on the Main PCB will switch off the heating.
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Continued on next page
2-8 | 1998081

TGM3
and
TCM30
Service
Manual
2.TCM3
General Information, Continued
Specifications
199808-1
Environmental Requirements
Ambient temperature: 5 - 40 °C. *)
Relative humidity: 20 - 80 %.
*)
If
the
electrode
temperature
is
below
15
°C
before
calibration,
the
monitor
may
É
signal
Error
1,
indicating
that
the
electrode
did
not
reach
the
pre-set
temperature
within
3
minutes.
Calibrate then the monitor in two steps:
Calibrate
with
the
temperature
pre
set
to
37
°C.
Repeat
the
calibration
with
the
temperature
pre
set
to
the
actual
monitoring
temperature.
Ventilation Requirements
The
system
must
be
situated
in
a
well
ventilated,
dust
free
atmosphere.
Dimensions
Height (cm) 8
Width (cm) 24 *
Depth (cm) 26
Weight (kg) 2.7
Units
The
monitor
can
be
set-up
so
as
to
indicate
the
O,/CO,
tension
in
either
mmHg
or
kPa
directly.
Monitor Battery
Rechargeable
NiCd
battery.
The
duty
period
is
3
hours
per
charge,
typically,
at
25
°С.
The
recharging
time
is
approximately
8
hours
at
25
°C,
via the
mains
adapter.
Monitor pO, channel
Range:
0
-
800
mmHg
or
0
-
99.9
kPa
Accuracy:
Better
than
+
1
mmHg/0.1
kPa
t
0.1
%
of
reading
at
25
°C.
Polarisation Voltage: -680 mV
Continued on next page
2-9

2. TCM3
TCM3 and TCM30 Service Manual
General Information, Continued
Specifications
(continued)
2-10
Monitor pCO, channel
Range: 5 - 200 mmHg or 0.7 - 26.7 kPa.
Accuracy: Better than + 1 mmHg/0.1 kPa 0.1 % of reading at 25 °C.
Electrode Heat
Range: 0 - 600 mW + 10 % of reading.
Temperature Settings
37.0 °C, 41.0 °C, 41.5 °C, 42.0 °C, 42.5 °C, 43.0 °C, 43.5 °C, 44.0 °C,
44.5 °C, 45.0 °C.
Accuracy: Better than + 0.1 °C excluding sensor.
Alarms
Audio visual. The acoustic alarm will be activated after a delay of 5 seconds when
an alarm state has occurred.
pO, alarm limits: (selected by user) LOW: 0-99 mmHg/0 - 9.9 kPa
HIGH: 0 - 800 mmHg/0 - 99.9 kPa
pCO, alarm limits: (selected by user) LOW: 0-99 mmHg/0 - 9.9 kPa
HIGH: 0 - 200 mmHg/0 - 26.7 kPa
Temperature: + 0.3 °C deviation from preset value wili
cause alarm.
Battery low: Alarm goes on before the battery is empty
Leakage Currents
Enclosure Leakage Current: Max. 100 uA
Patient Leakage Current: Max. 10 uA
Continued on next page
199808-1

TCM3 and TCM30 Service Manual
2. TCM3
General Information, Continued
Specifications Serial data output
(continued)
Signal
Connector
Pin
TX data 11
RX data (normally not used) 14
Common Return 15
Transfer parameters
2400 baud
7 bits/character
Odd parity
2 stop bits
Analog oufputs
Channel/
|
Parameter
Output
Connector
|
|1/pin9
PO
5
mV/mmHg
(40
mV/kPa)
or
1
mV/mmHg
(10
mV/kPa)
(selected
in
the
AUX
program
200/800
mmHg
or
25.0/99.9 kPa)
2/pin10
|
pCO,
|
10
mV/mmHg
(100
mV/kPa)
or
5
mV/mmHg
(40
mV/kPa)
(selected
in
the
AUX
program
100/200
mmHg
or
10.0/25.0 kPa)
3/pin8
Heat/temp.
|
Heat:
mW
is
converted
to
mV.
Temperature:
50
mV/°C,
range
30
°C
to
50
°C.
Examples: |
30 °C gives an output of 0 mV.
43
°C
gives
an
output
of
650
mV
4/pin5
Alarm
Acoustic
alarm
activated:
1000
mV
Acoustic alarm not activated: 0 mV
Max. source current: 1 mA
--/pin15 | Common
return
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2. TCM3 - TCM3 and TCM30 Service Manual
2-12 199808-1

TCM3
and
TCM30
Service
Manual
2.
TCM3
Test Procedures
Overview
Introduction
This
section
details
the
procedures
for
testing
and
adjusting
the
TCM3
monitor,
For
each
of
the
paragraphs
the
required
tools
for
testing
are
listed.
Contents
This
chapter
contains
the
following
topics.
199808-1
2-13

2. TCM3
TCMS and TCM30 Service Manual
Introduction
Checkout and This Section describes the necessary procedures for checking and adjusting the
Adjustment TCM3.
For TCM3 with serial nos. from 101R22N01 onwards, some test procedures differ
considerably from the procedures for the TCM3 below RUN 22.
Yearly RADIOMETER recommends a yearly preventive maintenance checkout which
Maintenance includes:
Checkout and Adjustment.
Monitor Performance Check.
These procedures are outlined in the following two paragraphs.
Repairs Repairs to TCM3 are made only by replacing defective PCBs, which are returned
9-14
to RADIOMETER for exchange. This is to ensure patient and functional safety.
199808.1