TCM4/40 operator’s manual

TCM4/40
operator’s
manual
 Table of contents

1. Introduction
TCM4/40
monitoring
systems
2. What is what

3. Menu structure and setup programs

4. Installation and maintenance

5. Calibration

Operator's manual
From software version 3.0
6. In vivo monitoring

7. Troubleshooting

8. Specifications and ordering information

9. Functional description

Index

Date of issue
 System performance
The procedures described in this manual must be observed in order to ensure proper system
performance, and to avoid hazards.
Radiometer cannot provide or verify system performance characteristics if the system is not installed,
used and maintained in accordance with Radiometer procedures or if accessories not meeting the
specifications provided by Radiometer are used.
Radiometer warrants that the data media on which the software included in the system is furnished is
free from defects in material and workmanship under normal use for three (3) months from the date of
delivery as evidenced by a copy of invoice or receipt.

Third-party software and trademarks

The TCM4/40 monitoring systems comprise the Microsoft® Windows® CE 5.0 program.
By using the system, you accept the terms of the Software License Agreement(s) of the provider(s) of
the above software as shown in the End User License Agreement(s) included in this manual. If you
cannot accept the terms of the Software License Agreement(s), you should not use the system, but
immediately contact your provider for a return of the system and a refund of the purchase price.
Microsoft® and Windows® are trademarks of Microsoft Corporation.

Warranties and disclaimer

Radiometer makes no warranties, express or implied, other than expressly stated.
Any warranties expressly stated in this document are conditional upon the system being installed, used
and maintained in accordance with Radiometer procedures, including that only accessories meeting the
specifications provided by Radiometer are used.
Radiometer disclaims any liability for system performance if the system is not installed, used and
maintained in accordance with Radiometer procedures or if accessories not meeting the specifications
provided by Radiometer are used.
Further, Radiometer disclaims any liability for loss of data and direct, consequential or other damages,
including loss of profit or loss of business, whether such claim for damages is based upon contract,
negligence or tort (including strict liability), and even if Radiometer has knowledge of the possibility of the
potential damage or loss.

Confidentiality
The contents of this document shall not be reproduced or communicated to any third party without the
prior written consent of Radiometer.

Changes
This document is subject to change without notice and you are urged to contact Radiometer to verify
whether the document has been changed.
While every effort is made to ensure the correctness of the information provided in this document as
changed from time to time, Radiometer disclaims any liability for errors and omissions.

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of Radiometer Medical ApS.
© 2011 Radiometer Medical ApS. All rights reserved.
 End user license agreement for Microsoft Software

• You have acquired a device ("TCM4/40 monitor") that includes software licensed by Radiometer Medical ApS
from Microsoft Licensing Inc. or its affiliates ("MS"). Those installed software products of MS origin, as well as
associated media, printed materials and "online" or electronic documentation ("SOFTWARE") are protected by
international intellectual property laws and treaties. The SOFTWARE is licensed, not sold. All rights reserved.

• IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT ("EULA"), DO NOT USE THE DEVICE
OR COPY THE SOFTWARE. INSTEAD, PROMPTLY CONTACT Radiometer Medical ApS FOR INSTRUCTIONS
ON RETURN OF THE UNUSED DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT
NOT LIMITED TO USE ON THE DEVICE, WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR
RATIFICATION OF ANY PREVIOUS CONSENT).

• GRANT OF SOFTWARE LICENSE. This EULA grants you the following license:

You may use the SOFTWARE only on the DEVICE.

NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. Radiometer Medical ApS HAS
INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED
UPON Radiometer Medical ApS TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE
SOFTWARE IS SUITABLE FOR SUCH USE.

NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided "AS IS" and with all faults. THE
ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY, AND EFFORT
(INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO, THERE IS NO WARRANTY AGAINST
INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST INFRINGEMENT. IF YOU
HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE SOFTWARE, THOSE
WARRANTIES DO NOT ORIGINATE FROM, AND ARE NOT BINDING ON, MS.

Note on Java Support. The SOFTWARE may contain support for programs written in Java. Java technology is
not fault tolerant and is not designed, manufactured, or intended for use or resale as online control equipment in
hazardous environments requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft
navigation or communication systems, air traffic control, direct life support machines, or weapons systems, in
which the failure of Java technology could lead directly to death, personal injury, or severe physical or
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decompile, or disassemble the SOFTWARE, except and only to the extent that such activity is expressly
permitted by applicable law notwithstanding this limitation.

SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently transfer rights under
this EULA only as part of a permanent sale or transfer of the Device, and only if the recipient agrees to this
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EXPORT RESTRICTIONS. You acknowledge that SOFTWARE is of US-origin. You are to comply with all
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and other governments. For additional information on exporting the SOFTWARE, see
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 Contents

1. Introduction.................................................................................................................... 1-1
Names, intended use and limitations...................................................................1-2
Symbols used on the monitor..............................................................................1-4
Symbols used in the manual................................................................................1-6
2. What is what................................................................................................................... 2-1
TCM4/40 monitoring systems.............................................................................2-2
Monitor – top and front .......................................................................................2-3
Monitor – rear .....................................................................................................2-4
The screen: general elements ..............................................................................2-5
Online tutorials....................................................................................................2-8
Touch key glossary .............................................................................................2-9
3. Menu structure and setup programs............................................................................ 3-1
Menu structure ....................................................................................................3-2
List of setup programs.........................................................................................3-3
View setup...................................................................................................................... 3-4
Normal view........................................................................................................3-5
Trend table view..................................................................................................3-7
Trend curve view.................................................................................................3-8
Parameter setup ............................................................................................................ 3-9
pCO2 ..................................................................................................................3-10
pO2 ....................................................................................................................3-11
SpO2/Pulse.........................................................................................................3-12
Blood gas...........................................................................................................3-13
Calibration setup......................................................................................................... 3-14
SmartCal............................................................................................................3-15
Calibration status...............................................................................................3-16
Printer setup ................................................................................................................ 3-17
Technical setup............................................................................................................ 3-19
Technical settings..............................................................................................3-20
Date/time ...........................................................................................................3-22
Default values ...................................................................................................3-23
4. Installation and maintenance ........................................................................................ 4-1
Operating requirements.......................................................................................4-2
Installing the monitoring system .........................................................................4-3
Shutting down the monitor..................................................................................4-5
Contents TCM4/40 operator's manual

Cleaning the monitor...........................................................................................4-6

Maintenance of the monitor ................................................................................4-7
Preparation and maintenance of the tc sensors .......................................................... 4-9
General information about membraning ...........................................................4-10
Cleaning the sensor head of the E5480 sensor..................................................4-11
Membraning the E5480 sensor..........................................................................4-12
Membraning the E5280 and E5260 sensors......................................................4-13
Cleaning, disinfection and storage of sensors ...................................................4-15
Maintenance of the SpO2 sensors............................................................................... 4-16
5. Calibration...................................................................................................................... 5-1
General information ............................................................................................5-2
Calibration...........................................................................................................5-3
Checking zero current and sensitivity .................................................................5-4
6. Patient monitoring ......................................................................................................... 6-1
General information ............................................................................................6-2
Application and removal of tc sensors ................................................................6-6
Application of SpO2 sensors ...............................................................................6-8
Patient monitoring (In vivo monitoring) ...........................................................6-11
Patient DMS ......................................................................................................6-13
Results in Normal view.....................................................................................6-16
Results in Trend table view...............................................................................6-18
Results in Trend curve view..............................................................................6-19
Analog output....................................................................................................6-21
Continuous data output: standard......................................................................6-22
Continuous data output: VueLink .....................................................................6-24
Continuous data output: MonLink ....................................................................6-29
Data export: serial .............................................................................................6-30
Data export: USB ..............................................................................................6-33
Alarms...............................................................................................................6-34
How to print ......................................................................................................6-38
Blood gas comparison .......................................................................................6-44
In vivo calibration .............................................................................................6-45
7. Troubleshooting ............................................................................................................. 7-1
The TCM4/40 systems ........................................................................................7-2
8. Specifications and ordering information...................................................................... 8-1
Specifications ......................................................................................................8-2
Accessories........................................................................................................8-14
TCM4/40 operator's manual Contents

9. Functional description ................................................................................................... 9-1

tcpCO2/tcpO2 measurement.......................................................................................... 9-2
Construction of sensors .......................................................................................9-3
pCO2 measuring principle ...................................................................................9-5
pO2 measuring principle......................................................................................9-6
Calibration of sensor ...........................................................................................9-7
Solutions and calibration gases .........................................................................9-10
Traceability certificates.....................................................................................9-11
Pulse oximetry measurement ..................................................................................... 9-15
Measuring principle ..........................................................................................9-16
Calibration of sensor .........................................................................................9-17

Index
Date of issue
Contents TCM4/40 operator's manual
 1. Introduction

Names, intended use and limitations........................................................................ 1-2

Symbols used on the monitor................................................................................... 1-4
Symbols used in the manual..................................................................................... 1-6
1. Introduction TCM4/40 operator's manual

Names, intended use and limitations

Proprietary TCM4 monitor and TCM40 monitor.

names
Common names Transcutaneous pCO2/pO2 monitoring system (TCM4) and Transcutaneous
pCO2/pO2/SpO2/Pulse monitoring system (TCM40)

TCM4 series The TCM4 and TCM40 monitoring systems are part of the TCM4 Series
monitors monitoring system.

Reference This operator’s manual for the TCM4/40 monitoring systems is intended for use as
a reference. It provides detailed operating instructions and answers to relevant
questions about your monitoring systems.

All rights At the time of printing, the manual is in conformity with the systems. All rights are
reserved reserved for instruments, circuits, techniques and names appearing in the manual.

Intended use The TCM4 monitoring system is intended for continuous transcutaneous monitoring
of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures. It is indicated for
use on neonates, pediatrics, and adults not under gas anesthesia.
The TCM40 monitoring system is intended for continuous transcutaneous monitoring
of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures as well as of oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for use on
neonates, pediatrics and adults not under gas anesthesia.

Sensors The sensors are provided non-sterile and are intended for reuse.
For information on site locations, see the relevant section about application of
sensors in chapter 6 In vivo monitoring.

Environment of In hospital/clinical environment.

use

Operator profile Only trained health care personnel are permitted to use the monitor.

Limitations Transcutaneous monitoring is intended only as an adjunct in patient assessment

and must be used in conjunction with clinical signs and symptoms.

WARNING – Risk of incorrect measurements

tcpCO2/tcpO2 monitoring should not be used on patients in a compromised
hemodynamic state as this may cause incorrect measurements.
WARNING – Risk of incorrect measurements
The DS100A SpO2 sensor is contraindicated for use on active patients or
for prolonged use. It is not designed for long-term monitoring. Using this
sensor for long-term monitoring may result in incorrect measurements.

Continued on next page

1-2
TCM4/40 operator's manual 1. Introduction

Names, intended use and limitations, Continued

Limitations
WARNING – Risk of allergic reactions
(continued)
The OXIband A/N and P/I SpO2 sensors are contraindicated for use on
patients who exhibit allergic reactions to the pressure-sensitive adhesive
on the wraps.
CAUTION – US federal law restriction
Federal law restricts this device to sale by or on the order of a physician.
NOTICE: This equipment is not a blood gas device.

Legal notices • Instruments should be repaired by authorized service personnel or by

Radiometer-certified representatives only.
• Purchase of the TCM40 monitoring system confers no express or implied license
under any Nellcor patent to use this instrument with any oximetry sensor that is
not manufactured or licensed by Nellcor.

1-3
1. Introduction TCM4/40 operator's manual

Symbols used on the monitor

Symbol Explanation
CSA approved

Caution, consult accompanying documents

Temperature limitation

Indicates that the product complies with the requirements

of the Medical Device Directive 93/42/EEC June 1993.
This product is a class IIa device.
Serial number

Non-ionizing radiation

Type BF equipment (body floating)

Manufacturer

USB

Waste of Electrical and Electronic Equipment (WEEE)

The symbol indicates that:
• Radiometer Medical ApS and its distributors
within the European Union (EU) and associated
states have taken the necessary steps to comply
with the directive 2002/96/EC on waste electrical
and electronic equipment (WEEE)
• The instrument, when reaching its end of life, must
be collected and recycled separately from other
waste according to national requirements.
Please contact your local Radiometer distributor
for instructions.
Environmental implications:
WEEE contains materials that are potentially hazardous to
the environment and to human health.

Continued on next page

1-4
TCM4/40 operator's manual 1. Introduction

Symbols used on the monitor, Continued

Symbol Explanation
COM gate

Ethernet interface connection to network. Not for phone

connection.

Off (Power: disconnection from the mains)

On (Power: connection to the mains)

Monitor on/off

Fuse

1-5
1. Introduction TCM4/40 operator's manual

Symbols used in the manual

This manual contains alerts, which are important and should be read carefully
before performing the related procedures. The manual also contains non-safety
information.

Symbol Signal word Explanation

WARNING A warning alerts the reader about a situation which, if
not avoided, could result in death or serious injury. It
may also describe potential serious adverse reactions
and safety hazards.
CAUTION A caution alerts the reader about a potentially
hazardous situation which, if not avoided, may result in
minor or moderate injury to the user or the patient or
damage to the equipment or other property. It may also
be used to alert against unsafe practices. This includes
the special care necessary for the safe and effective use
of the device and the care necessary to avoid damage
to the device that may occur as a result of use or
misuse.
NOTICE Addresses practical information that is not related to
personal injury ("need-to-know information").
Manufacturer

Indicates that the product complies with the

requirements of the Medical Device Directive
93/42/EEC June 1993.
This product is a class IIa device.

1-6
 2. What is what

TCM4/40 monitoring systems.................................................................................. 2-2

Monitor – top and front ............................................................................................ 2-3
Monitor – rear .......................................................................................................... 2-4
The screen: general elements ................................................................................... 2-5
Online tutorials......................................................................................................... 2-8
Touch key glossary .................................................................................................. 2-9
2. What is what TCM4/40 operator's manual

TCM4/40 monitoring systems

Introduction The TCM4 monitoring system includes:

• Base unit
• tcpCO2/tcpO2 module
• Combined tcpCO2/tcpO2 sensors or single tcpCO2 sensor

The TCM40 monitoring system includes:

• Base unit
• tcpCO2/tcpO2 module and SpO2 module
• Sensors for tcpCO2/tcpO2 module: Combined tcpCO2/tcpO2 sensors or single
tcpCO2 sensor
• Sensors for SpO2 module: SpO2 sensors (Nellcor DS100A, Nellcor Oxiband A/N
or Nellcor Oxiband P/I)

NOTICE: For ordering information, see the section Accessories in chapter 8.

2-2
TCM4/40 operator's manual 2. What is what

Monitor – top and front

Front view Touch screen Handle

Calibration
chamber SpO2
module

tcpCO2/tcpO2
module
Battery
indicator

Monitor support
and holder for
sensor cable ON/OFF button

Monitor-elevating support

Parts and Part Function

functions
Handle For carrying the monitor.
Touch screen For easy communication between operator and monitor.
Calibration For storage and calibration of tcpCO2/tcpO2 sensor.
chamber
tcpCO2/tcpO2 For transcutaneous measurements of tcpCO2 and tcpO2 and
module calibration of the sensor.
Monitor support For supporting the monitor and holding the sensor cable.
and holder for
sensor cable
Monitor-elevating For supporting the monitor at an elevated angle.
support
For turning the monitor ON and OFF.
ON/OFF button
For indicating whether the battery is being recharged or
not. If the light is on, the battery is being recharged.
Battery indicator
NOTICE: Only possible if the power switch on the back
of the monitor is in the ON position.
SpO2 module For measurements of SpO2 and pulse rate.
(TCM40 monitor
only)

2-3
2. What is what TCM4/40 operator's manual

Monitor – rear

Rear view

SpO2 sensor tcpCO2/tcpO2

socket sensor socket
Module release
Battery

Line fuse Ventilator

Power switch

Power socket

Ethernet (for Serial port/ 2 USB ports

authorized service analog output
personnel only)

Parts and Part Function

functions
Battery For allowing monitoring during transport and power
failure.
SpO2 sensor socket For connecting an SpO2 sensor to the monitor.
(TCM40 monitor
only)
Line fuse 1.25 AT. For preventing a short circuit.
WARNING – Risk of fire
Replace fuse only as recommended by Radiometer.
Otherwise you risk that the monitor catches fire.
Power socket For connecting a power cord to the monitor.
Serial port (RS232) For connecting the monitor to an external computer.
Analog output For connecting the monitor to a peripheral device such as a
polysomnograph.
USB ports For connecting the monitor to an external printer and a
memory stick.
NOTICE: It is only possible to use one of the ports at a
time.
Module release For releasing the sensor module from the monitor with a
release key.
tcpCO2/tcpO2 For connecting a tcpCO2/tcpO2 sensor to the monitor.
sensor socket
Power switch For turning the power supply to the monitor ON and OFF.
NOTICE: If the power supply is ON, the battery will be
recharged when needed.

2-4
TCM4/40 operator's manual 2. What is what

The screen: general elements

Screen types There are two types of screens on the TCM4/40 monitors: view (i.e. Normal, Trend
table and Trend Curve) and menu screens.

View screen The view screens are divided into the following fields:
configuration
Time/Date System/view status Bat. ID

Curve display pCO2/pO2 display

pCO2/pO2

---------------------------------------------
Pulse/SpO2 display
Power/SpO2

Touch keys

NOTICE: SpO2 and pulse rate are available on the TCM40 monitor only. On the
TCM4 monitor, the lower part of the curve display will either show the power
curve or be empty, and the Pulse/SpO2 display will always be empty (see examples
on next page).

Part Shows
Time and date The real time (24-hour cycle) and date
System/view Normal view, Trend table view, Trend curve view, New
status patient, Alert or Alarm
Bat. The battery level when the monitor is running on battery.

Full , almost full , low and critically low

ID Patient identification number. Gives access to Patient DMS.
Curve display TCM4 monitor: pCO2, pO2 and power
TCM40 monitor: pCO2, pO2 and SpO2
Sensor status (e.g. Calibrating) and gas level (only displayed
during calibration and if there is 10 % or less gas left in the gas
cylinder).
Barometric pressure (only displayed during calibration).
pCO2/pO2 pCO2, pO2, Corr., Power, Temp, SmartHeat, In vivo calibration
display active, (alarm is ON) and (alarm is OFF)
Pulse/SpO2 Pulse, SpO2, "HI OFF" (SpO2 alarm high is disabled),
display
(alarm is ON) and (alarm is OFF)

Continued on next page

2-5
2. What is what TCM4/40 operator's manual

The screen: general elements, Continued

Example of
Normal view
screen on
TCM40 monitor

Example of
Normal view
screen on TCM4
monitor

NOTICE: In Measuring mode, the Event touch key replaces the Tutorial key.

Touch keys in Touch key Function

Normal view
ID Gives access to Patient DMS.
Site time xx:xx Resets the site timer to its preset value (see Parameter setup).
Tutorial Gives access to instruction videos – when not monitoring.
Event Marks an event during monitoring.
Calibrate Starts a calibration of the sensor (and the SmartCal period, if
the function is set to ON in the setup).
Print Gives access to the Printer start/stop time screen.
Setup Gives access to all the setup menus and submenus.
Alarm silence Silences/resets the alarm system.

Continued on next page

2-6
TCM4/40 operator's manual 2. What is what

The screen: general elements, Continued

Menu screen The menu screens are divided into the following fields:
configuration
Menu tabs

Submenus/settings

Touch keys

The menu screens contain the following tabs, which give access to the setup menus
and submenus: View, Parameter, Calibration, Printer and Technical (password
protected).

Example of Menu tabs

menu screen

Settings

Submenus

Touch keys

NOTICE: SpO2 is available on the TCM40 monitor only.

Menu screen Touch key Function

touch keys
OK Accepts the changes and returns to the main screen.
Apply Accepts the changes without leaving the menu screen.
Cancel Returns to the main screen without saving changes.

2-7
2. What is what TCM4/40 operator's manual

Online tutorials

Tutorials The tutorials are short video sequences of commonly used procedures. To access
the tutorials, press Tutorial.
NOTICE: In Measuring mode, the Event touch key replaces the Tutorial key.

NOTICE: The DS100A sensor tutorial can only be selected on the TCM40
monitor.

Touch keys Touch key Function

Pauses the selected tutorial.

Plays the selected tutorial.

Scroll backward/forward one step in the selected tutorial.

and
Returns to the TCM tutorials screen.

Exits the tutorial and returns to Normal view.

2-8
TCM4/40 operator's manual 2. What is what

Touch key glossary

Touch keys In the text, touch keys are written in bold italic throughout the manual.
The glossary of all the touch keys used in the software with their description is
given in alphabetical order in the table below:

Touch key Function

Adds a check mark to the highlighted patient ID/session
number (in Patient DMS).
Displays detailed information about the highlighted patient
ID/session number (in Patient DMS).
Alarm silence Silences/resets the alarm system.
Apply Accepts the changes made in the settings without leaving
the respective menu screen.
Blood gas Gives access to the Blood gas setup where blood gas
values can be keyed in.
Cal. status Gives information about the last calibration.
Calibrate Starts a calibration of the electrode.
Cancel Returns to the main screen without saving the changes
made in the settings.
Cursor Adds/removes a cursor in the Trend curve view.
Date/time Gives access to the Date/time setup (password protected).
Default values Changes all settings to Radiometer default values
(password protected).
Delete config. file Part of the Service setup (only for service purposes).
Enter Registers the entered password.
Event Marks an event during monitoring.
Export Exports the patient information and measuring data for the
patient IDs/session numbers with a check mark (in Patient
DMS).
ID Gives access to Patient DMS.
In vivo calibration Starts an in vivo calibration, i.e. a correction of the
measured tcpCO2/tcpO2 values with the keyed-in blood gas
values.
Normal Gives access to the Normal view setup.

Continued on next page

2-9
2. What is what TCM4/40 operator's manual

Touch key glossary, Continued

Touch keys
(continued) Touch key Function
OK Accepts the changes made in the settings and returns to the
main screen.
pCO2 In the Parameter menu, it gives access to the pCO2
parameter setup.
In the Trend curve setup, it gives access to the pCO2 curve
range screen.
pO2 In the Parameter menu, it gives access to the pO2
parameter setup.
In the Trend curve setup, it gives access to the pO2 curve
range screen.
Power Gives access to the Power range screen.
Print Gives access to the Printer start/stop time screen.
Service menu Gives access to the Service setup (password protected).
Setup Gives access to all the Setup menus.
Site time Resets the site timer to its preset value (see Parameter
setup).
SmartCal Keeps the electrode ready for use (i.e. calibrated for max.
12 hours).
SpO2/Pulse In the Parameter menu, it gives access to the SpO2/Pulse
parameter setup.
In the Trend curve setup, it gives access to the SpO2/Pulse
curve range screen.
System info Part of the Service setup (only for service purposes).
Tech. settings Gives access to the Technical settings (password
protected).
Test Part of the Service setup (only for service purposes).
Touch screen Part of the Service setup (only for service purposes).
calibration
Trend curve Gives access to the Trend curve setup.
Trend table Gives access to the Trend table setup.
Tutorial Gives access to instruction videos.

Continued on next page

2-10
TCM4/40 operator's manual 2. What is what

Touch key glossary, Continued

Arrow touch Touch key Function

keys
Changes the settings of the highlighted option.
or
Scrolls the displayed screen/parameters upward or
or downward.
Scrolls the displayed screen/parameters forward or
or backward.
Scrolls quickly to the most recent result.

Deletes one character at a time.

Moves one character at a time to the left or the right.

or

Tutorial touch Touch key Function

keys
Pauses the selected tutorial.

Plays the selected tutorial.

Scroll backward/forward one step in the selected tutorial.

and
Returns to the TCM Tutorials screen.

Exits the tutorial and returns to Normal view.

2-11
2. What is what TCM4/40 operator's manual

2-12
3. Menu structure and setup programs

Menu structure ...................................................................................................... 3-2

List of setup programs........................................................................................... 3-3
View setup............................................................................................................ 3-4
Normal view.......................................................................................................... 3-5
Trend table view.................................................................................................... 3-7
Trend curve view .................................................................................................. 3-8
Parameter setup .................................................................................................. 3-9
pCO2 .................................................................................................................... 3-10
pO2 ...................................................................................................................... 3-11
SpO2/Pulse .......................................................................................................... 3-12
Blood gas............................................................................................................. 3-13
Calibration setup............................................................................................... 3-14
SmartCal.............................................................................................................. 3-15
Calibration status................................................................................................. 3-16
Printer setup ...................................................................................................... 3-17
Technical setup .................................................................................................. 3-19
Technical settings................................................................................................ 3-20
Date/time............................................................................................................. 3-22
Default values ..................................................................................................... 3-23
3. Menu structure and setup programs TCM4/40 operator's manual

Menu structure

Menu structure The following diagram illustrates the menu structure of the TCM4/40 monitors.

Setup

View Parameter Calibration Printer Technical

pCO2 SmartCal T ime Enter

pO2 Cal. status interval password
Sp O2/Pulse* Time span
Blood gas Report type
Curve ranges
Printer type

Main screen Normal Trend table Trend curve

View Ti me Time span

Time span interval Curve
Curve ranges ranges
pCO2
pCO2 pO2
pO2 Power
Pow er** SpO2/Pulse*

Screen saver Select curves

Technical Date/time Service Default

settings menu values

Date/time For service

se ttings personnel
Date format only

* Available on the TCM40 monitor only.

** Available on the TCM4 monitor only.

NOTICE: If no touch key is activated for 30 seconds, the main screen (Normal
view) is displayed.

3-2
TCM4/40 operator's manual 3. Menu structure and setup programs

List of setup programs

Accessing the Press the Setup touch key to get access to the Setup menus:
Setup menus
• View
• Parameter
• Calibration
• Printer
• Technical

Detailed information about the five main Setup menus is given in the following
sections.

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3. Menu structure and setup programs TCM4/40 operator's manual

View setup

Normal view..................................................................................................... 3-5

Trend table view............................................................................................... 3-7
Trend curve view ............................................................................................. 3-8

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TCM4/40 operator's manual 3. Menu structure and setup programs

Normal view

Introduction In the Normal view setup, it is possible to select which parameters will be shown
in Normal view, to set the time span of the graphical display and to activate the
screen saver.
NOTICE: If no touch key is activated for 30 seconds, the main screen (Normal
view) is displayed.

Accessing the To access the Normal view setup, press Setup → Normal.
program
Normal view setup on TCM40 monitor:

Normal view setup on TCM4 monitor:

Selecting Step Action

Normal view
1. Use the Up and Down arrows to select the curves that are to be shown
options
in the curve area in Normal view.
NOTICES:
• Parameter values will always be shown.
• The number of parameters to choose from depends on the sensor
type installed (combined pCO2/pO2 or pCO2 only), and whether the
pO2 parameter is set to ON or OFF in Technical setup.

Continued on next page

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3. Menu structure and setup programs TCM4/40 operator's manual

Normal view, Continued

Selecting Step Action

Normal view
2. Use the Up and Down arrows to select the time span.
options
(continued) NOTICE: The time span selection only applies to the pCO2, pO2 and
Power curves.
3. Select the curve range options of the individual parameters by pressing
each of the parameters and, in the appearing screens, selecting the high
and low values.
4. Press OK to accept the changes and return to the Normal view setup
screen, or press Cancel to return to the Normal view setup screen
without saving changes.
5. If required, select (3) the screen saver.
NOTICES:
• To activate the screen saver, it is necessary to press OK before
leaving the Normal view setup.
• The option is only visible if it has been activated in Technical
settings.
• The screen saver is primarily meant for sleep labs, to reduce the
backlight from the display.
• Touching the screen deactivates the screen saver; and to reactivate it,
the option must be selected in Normal view setup.
6. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the Normal view setup
• Cancel to return to the main screen without saving changes

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TCM4/40 operator's manual 3. Menu structure and setup programs

Trend table view

Introduction In the Trend table setup, it is possible to select the time interval between each
record in the Trend table.

Accessing the To access the Trend table setup, press Setup → Trend table.
program

Selecting Step Action

Trend table
1. Use the Up and Down arrows to select the time interval.
options
2. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the Trend table setup
• Cancel to return to the main screen without saving changes

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3. Menu structure and setup programs TCM4/40 operator's manual

Trend curve view

Introduction In the Trend curve setup, it is possible to set the time span of the graphic display
and the ranges for pCO2, pO2, Power and SpO2/Pulse, and to select which
parameter(s) (maximum two) should be displayed on the Trend curve.
NOTICE: SpO2 and pulse are available on the TCM40 monitor only.

Accessing the To access the Trend curve setup, press Setup → Trend curve.
program

Selecting Step Action

Trend curve
1. Use the Up and Down arrows to select the time span.
options
2. Select maximum two parameters to be displayed as trend curves.
NOTICE: If two parameters are selected, one of these must be
deselected in order to be able to select a new parameter.
3. Select the curve range options of the individual parameters by
pressing each of the parameters and, in the appearing screens,
selecting the high and low values, using the arrow keys.
4. Press OK to accept the changes and return to the Trend curve setup
screen, or press Cancel to return to the Trend curve setup screen
without saving changes.
5. In the Trend curve setup screen, press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the Trend curve setup
• Cancel to return to the main screen without saving changes

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TCM4/40 operator's manual 3. Menu structure and setup programs

Parameter setup

WARNING – Risk of incorrect monitoring

Make sure to select the alarm limits carefully. Setting alarm limits to
extreme values can render the alarm system useless.

pCO2 ................................................................................................................. 3-10

pO2 ................................................................................................................... 3-11
SpO2/Pulse ....................................................................................................... 3-12
Blood gas.......................................................................................................... 3-13

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3. Menu structure and setup programs TCM4/40 operator's manual

pCO2

Accessing the To access the pCO2 setup, press Setup → Parameter → pCO2.
program
pCO2 settings Settings Options
pCO2 alarm ON/OFF
NOTICE: The alarm is triggered if the parameter value
exceeds or is equal to the alarm limit (high or low). It consists
of a visual part (the parameter value and an alarm text will be
flashing) and an acoustic part (a discontinuous tone).
pCO2 alarm high 6-200 mmHg (in steps of 1); 0.8-26.7 kPa (in steps of 0.1)
pCO2 alarm low 5-99 mmHg (in steps of 1); 0.7-9.9 kPa (in steps of 0.1)
Alarm sound 1-5 (1 is minimum)
level1
Sensor temp. 2 37.0-45.0 °C (in steps of 0.5)
NOTICE: If the set sensor temperature is changed during
measurement, a new calibration is required.
SmartHeat2 ON/OFF
NOTICE: If SmartHeat is set to ON, it adds +1 °C (max.
temp. 45 °C) to the set sensor temperature for 5 minutes after
the sensor has been removed from the calibration chamber.
Site time2 OFF; ½-12 hours (in steps of ½ hour)
2
Site time heat ON/OFF
NOTICE: If Site time heat is set to OFF, the sensor heat is
switched off when the site timer reaches zero; if set to ON,
the heat continues.
1
The setting of this option is common to pCO2, pO2 and SpO2.
2
The setting of this option is common to pCO2 and pO2.

Selecting Step Action

pCO2 settings
1. Select the relevant option with the touch key.
2. Choose the settings of that option with the Up or Down arrow key.
3. Follow steps 1-2 for the remaining options.
4. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the pCO2 setup
• Cancel to return to the main screen without saving changes

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TCM4/40 operator's manual 3. Menu structure and setup programs

pO2

Accessing the To access the pO2 setup, press Setup → Parameter → pO2.
program
pO2 settings Settings Options
pO2 alarm ON/OFF
NOTICE: The alarm is triggered if the parameter value
exceeds or is equal to the alarm limit (high or low). It consists
of a visual part (the parameter value and an alarm text will be
flashing) and an acoustic part (a discontinuous tone).
pO2 alarm high 1-800 mmHg (in steps of 1); 0.1-99.9 kPa (in steps of 0.1)
pO2 alarm low 0-99 mmHg (in steps of 1); 0.0-9.9 kPa (in steps of 0.1)
Alarm sound 1-5 (1 is minimum)
level1
Sensor temp.2 37.0-45.0 °C (in steps of 0.5)
NOTICE: If the set sensor temperature is changed during
measurement, a new calibration is required.
SmartHeat2 ON/OFF
NOTICE: If SmartHeat is set to ON, it adds +1 °C (max.
temp. 45 °C) to the set sensor temperature for 5 minutes after
the sensor has been removed from the calibration chamber.
Site time2 OFF; ½-12 hours (in steps of ½ hour)
2
Site time heat ON/OFF
NOTICE: If Site time heat is set to OFF, the sensor heat is
switched off when the site timer reaches zero; if set to ON,
the heat continues.
1
The setting of this option is common to pCO2, pO2 and SpO2.
2
The settings of these options are common to pCO2 and pO2.

Selecting Step Action

pO2 settings
1. Select the relevant option with the touch key.
2. Choose the settings of that option with the Up or Down arrow key.
3. Follow steps 1-2 for the remaining options.
4. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the pO2 setup
• Cancel to return to the main screen without saving changes

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3. Menu structure and setup programs TCM4/40 operator's manual

SpO2/Pulse

Accessing the To access the SpO2/Pulse setup, press Setup → Parameter → SpO2/Pulse.
program
SpO2/Pulse Settings Options
settings
SpO2 alarm ON/OFF
NOTICE: The alarm is triggered if the parameter value
exceeds or is equal to the alarm limit (high or low). It consists
of a visual part (the parameter value and an alarm text will be
flashing) and an acoustic part (a discontinuous tone).
SpO2 alarm OFF/86-100 % (in steps of 1)
high
WARNING – Risk of patient injury
Make sure to select the upper alarm limit for oxygen
saturation carefully and in accord with accepted
clinical standards. High oxygen levels may predispose
a premature infant to develop retinopathy.
NOTICE: SpO2 alarm high can be disabled ("HI OFF" will
be displayed beneath the alarm symbol) while SpO2 alarm low
is kept active.
SpO2 alarm low 85-99 % (in steps of 1)
SatSeconds OFF/10-100 (in steps of 10)
Alarm sound 1-5 (in steps of 1)
level1
Pulse alarm ON/OFF
Pulse alarm 35-240 bpm (in steps of 5)
high
Pulse alarm low 30-235 bpm (in steps of 5)
1
The setting of this option is common to pCO2, pO2 and SpO2.

Selecting Step Action

SpO2/Pulse
settings
1. Select the relevant option with the touch key.
2. Choose the settings of that option with the Up or Down arrow key.
3. Follow steps 1-2 for the remaining options.
4. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the SpO2/Pulse setup
• Cancel to return to the main screen without saving changes

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TCM4/40 operator's manual 3. Menu structure and setup programs

Blood gas

Introduction In the Blood gas setup it is possible to:

• key in the blood gas values of a patient to compare these with transcutaneous
measurements from the same patient. The blood gas values are displayed as
blood drops in all views, as well as on all printed reports.
• calibrate the transcutaneous measurements against the blood gas values (in vivo
calibration), and all results will then be displayed as red stars.

Accessing the To access the Blood gas setup, press Setup → Parameter → Blood gas.
program
NOTICE: The system must be monitoring.

In vivo
calibration

NOTICE: The In vivo calibration touch key is only visible if the option has been
activated in Technical settings (see Technical settings later in this chapter).

Procedures For the procedures on how to key in a blood gas value and how to perform an in
vivo calibration, see Blood gas comparison and In vivo calibration in chapter 6.

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3. Menu structure and setup programs TCM4/40 operator's manual

Calibration setup

SmartCal........................................................................................................... 3-15
Calibration status.............................................................................................. 3-16

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TCM4/40 operator's manual 3. Menu structure and setup programs

SmartCal

Purpose The SmartCal function makes sure that the monitor is always ready for monitoring
by calibrating the sensor when needed.

Accessing the To access the SmartCal setup, press Setup → Calibration → SmartCal.
program

SmartCal Settings Options Function

settings
SmartCal ON/OFF Enables/disables the SmartCal function.
NOTICES:
• When enabled, the monitor will calibrate auto-
matically. The calibration interval may vary
from 5 minutes to 2 hours; and the maximum
measuring time will be reduced accordingly.
• Although the option is enabled, it is necessary
to press Calibrate to start a SmartCal period.
SmartCal Forever/ Defines the duration of the SmartCal period.
duration 1-12 hours
NOTICE: If set to forever, the monitor will
(in steps of 1)
calibrate whenever the sensor is placed in the
calibration chamber; if set to 1-12 hours, the
monitor will calibrate within the selected period,
and after a SmartCal period, it will be necessary
to press Calibrate to start a new SmartCal period.
Elapsed 0:00-12:00 Shows how much time has elapsed of the active
time (hours:minutes) SmartCal period.

Selecting Step Action

SmartCal
settings
1. Select the relevant option with the touch key.
2. Choose the settings of that option with the Up or Down arrow key.
3. Follow steps 1-2 for the remaining options.
4. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the SmartCal setup
• Cancel to return to the main screen without saving changes

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3. Menu structure and setup programs TCM4/40 operator's manual

Calibration status

Introduction The Calibration status screen shows the status of the last calibration.

Accessing the To access the Calibration status screen, press Setup → Calibration → Cal. Status.
program

Calibration Status info Unit Description

status
information Last cal. hour:minutes Shows the time of the last calibration.
Set temp. °C Shows the sensor temperature during the last
calibration.
Barometer mmHg/kPa Shows the barometric pressure during the last
calibration.
Cal. value O2 mmHg/kPa Shows the O2 calibration value.
Cal. value CO2 mmHg/kPa Shows the CO2 calibration value.
Gas level % Shows how much calibration gas is left in the
cylinder.
NOTICE: The level will be displayed as "High"
until there is less than 10 % left in the gas
cylinder, and then as a percentage.

Press OK or Cancel to return to the main screen.

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TCM4/40 operator's manual 3. Menu structure and setup programs

Printer setup

Introduction In the Printer setup, it is possible to:

• set the time interval between two values on the table printout
• set the time span of the measurements that are to be shown on the printout
• choose whether to print out the report as a table, a curve or both
• adjust the set curve ranges
• connect a color or a black-and-white (B/W) printer to the monitor

Accessing the To access the Printer setup, press Setup → Printer.

program

NOTICE: SpO2 and pulse are available on the TCM40 monitor only.

Selecting printer Step Action

settings
1. Select the time interval with the Up and Down arrow keys.
2. Select the time span with the Up and Down arrow keys.
NOTICE: The selected time span will influence the start time of the
Printer start/stop time screen, as the interval between the printer start
time and the printer stop time corresponds to the time span; i.e. if the
time span is set to 1 hour, the interval between the printer start time
and the printer stop time will also be 1 hour (see also How to print in
chapter 6: In vivo monitoring).
3. To change the curve range for pCO2, pO2, Power or SpO2/Pulse, press
the relevant parameter touch key and select the high and low values,
using the Up and Down arrows.

Continued on next page

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3. Menu structure and setup programs TCM4/40 operator's manual

Printer setup, Continued

Selecting printer Step Action

settings
4. Press OK to accept the changes and return to the Printer setup, or press
(continued)
Cancel to return to the Printer setup without saving the changes.
5. Select at least one report type: Table and/or Curve.
6. Select printer type: color or B/W (i.e. black and white).
NOTICES:
• It is only possible to connect a local printer to the monitor. Printing
over the network is not supported.
• Radiometer recommends that you use an HP printer with PCL3
protocol.
7. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the Printer setup
• Cancel to return to the main screen without saving changes

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TCM4/40 operator's manual 3. Menu structure and setup programs

Technical setup

Technical settings............................................................................................. 3-20

Date/time.......................................................................................................... 3-22
Default values .................................................................................................. 3-23

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3. Menu structure and setup programs TCM4/40 operator's manual

Technical settings

Accessing the To access the Technical settings, press Setup → Technical (enter password and
program press Enter) → Tech. Settings.

Technical Settings Options Function

settings
Meta. corr. 0-15 mmHg Defines the metabolic correction
factor (in steps of 1 mmHg); factor. To indicate that CO2 values
have been corrected, "Corr." is
0-1 kPa
displayed together with the pCO2
(in steps of 0.1 kPa)
value in Normal view.
Severinghaus ON/OFF If set to ON, all CO2 values are
corr. corrected with the Severinghaus
correction factor, and "Corr." is
displayed together with the pCO2
value in Normal view.
In vivo ON/OFF Enables/disables access to the In vivo
calibration calibration touch key in the Blood gas
setup.
Cal. gas mix 0.0-100.0 % A calibration constant.
pO2 (in steps of 0.1)
Cal. gas mix 0.0-10.0 % A calibration constant.
pCO2 (in steps of 0.1)

Unit mmHg/kPa Defines the pCO2/pO2 unit.

pCO2/pO2
pO2 ON/OFF Defines whether to display the pO2
parameter parameter or not.
NOTICE: This option only has an
effect when a combined tcpCO2/tcpO2
sensor is connected to the monitor.
Alarm mode Latching/ Defines whether the alarm is latching
non-latching (the monitor remains in alarm status
even though the alarm condition
ceases to exist) or non-latching (the
monitor resets itself as soon as the
alarm condition ceases to exist).
Continuous OFF, Standard, VueLink, Gives four possibilities for data
data output MonLink or Raw data output: standard, VueLink, MonLink
and raw data.
See chapter 6 for detailed information.
NOTICE: Raw data is for service
purposes only. For more information,
see the TCM4 Series service manual.

Continued on next page

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TCM4/40 operator's manual 3. Menu structure and setup programs

Technical settings, Continued

Technical Option Range (default) Function

settings
(continued) Data export OFF, USB or Serial Enables access to the Export touch
key (in Patient DMS), which is used to
export a dump of the trend data to a
memory stick or an external PC.
NOTICE: "Serial" is only available if
"Continuous data output" is set to
OFF.
Data export 2, 10, 30 or 60 seconds Defines the interval between the
interval export of data.
Display 10-100 % Defines the backlight brightness of the
brightness (in steps of 10) display.
NOTICE: Full backlight reduces the
lifetime of the display.
Screen saver ON/OFF Makes a screen saver option available
in Normal view setup.
pO2 analog 0-200 or 0-800 mmHg; Defines the pO2 analog output range.
range 0.0-26.7 or 0.0-99.9 kPa
pCO2 analog 0-100 or 0-200 mmHg; Defines the pCO2 analog output range.
range 0.0-13.3 or 0.0-26.7 kPa

Selecting Step Action

technical
settings
1. Select the relevant option with the touch key.
2. Choose the settings of that option with the Up or Down arrow key.
3. Follow steps 1-2 for the remaining options.
4. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the Technical settings
• Cancel to return to the main screen without saving changes

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3. Menu structure and setup programs TCM4/40 operator's manual

Date/time

Accessing the To access the Date/time settings, press Setup → Technical (enter password and
program press Enter) → Date/time.

WARNING – Risk of data loss

If the Date/time settings are changed backward in time, only the
measurements that have been performed prior to the new date/time will be
kept in the memory. Other data will be deleted.
.
NOTICE: Date and time cannot be set during measurement. Trying to do so will
result in an alert.

Changing The "Date/time settings" input field reflects the current settings.
date/time
settings Step Action
1. Select date format:
• MM-DD-YYYY (month-day-year)
• DD-MM-YYYY (day-month-year)
2. Move one character at a time in the "Date/time settings" input field
with the << and >> touch keys. Enter the new settings with the
numeric keypad.
3. Press:
• OK to accept the changes and return to the main screen
• Apply to accept the changes without leaving the Date/time settings
• Cancel to return to the main screen without saving changes

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TCM4/40 operator's manual 3. Menu structure and setup programs

Default values

Introduction The Default values function changes all parameter and monitor settings to factory
defaults. The default values are listed below.
NOTICE: When changing all settings to factory defaults, all kPa settings will
change to mmHg.

Changing Step Action

settings to
factory defaults
1. Press Setup → Technical (enter password and press Enter) →
Default values.
2. A dialog box with the text "This will return the monitor into default
setup and current setup will be lost" appears.
Press OK to change all parameter and monitor settings to factory
defaults or Cancel to exit without changing settings.

List of default Menus Settings Default

settings
Normal view Curve selection TCM40 monitor: pCO2/pO2/SpO2
TCM4 monitor: pCO2/pO2/Power
Time span 1 hour
Table view Time interval 15 minutes
Curve view Time span 8 hours
Curve selection TCM40 monitor: pCO2 and SpO2
TCM4 monitor: pCO2 and pO2
Curve range pCO2 high 60 mmHg/8.0 kPa
pCO2 low 0 mmHg/0.0 kPa
pO2 high 200 mmHg/26.7 kPa
pO2 low 0 mmHg/0.0 kPa
Power high 400 mW
Power low 0 mW
SpO2 high 100 %
SpO2 low 90 %
Pulse high 200 bpm
Pulse low 0 bpm

Continued on next page

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3. Menu structure and setup programs TCM4/40 operator's manual

Default values, Continued

List of default Menus Settings Default

settings
pCO2 pCO2 alarm ON
(continued)
pCO2 alarm high 50 mmHg/6.7 kPa
pCO2 alarm low 30 mmHg/4.0 kPa
Alarm sound level 2
Sensor temp. 43.0 °C
SmartHeat OFF
Site time 4 hours
Site time heat OFF
pO2 pO2 alarm ON
pO2 alarm high 95 mmHg/12.7 kPa
pO2 alarm low 60 mmHg/8.0 kPa
Alarm sound level 2
Sensor temp. 43.0 °C
SmartHeat OFF
Site time 4 hours
Site time heat OFF
SpO2/Pulse SpO2 alarm ON
SpO2 alarm high OFF
SpO2 alarm low 85 %
SatSeconds OFF
Alarm sound level 2
Pulse alarm ON
Pulse alarm high 170 bpm
Pulse alarm low 40 bpm
Calibration SmartCal OFF
SmartCal duration 4 hours

Continued on next page

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TCM4/40 operator's manual 3. Menu structure and setup programs

Default values, Continued

List of default Menus Settings Default

settings
Printer Time interval 15 minutes
(continued)
Time span 1 hour
Report type Table and curve
Printer type Color
Technical Meta. corr. factor 7 mmHg/1.0 kPa
Severinghaus corr. ON
In vivo calibration OFF
Cal. gas mix pO2 20.9 %
Cal. gas mix pCO2 7.5 %
Unit pCO2/ pO2 mmHg
pO2 parameter ON
Alarm mode Non-latching
Continuous data OFF
output
Data export OFF
Data export interval 10 seconds
Display brightness 70 %
Screen saver OFF
pCO2 analog range 0-200 mmHg/0.0-26.7 kPa
pO2 analog range 0-800 mmHg/0.0-99.9 kPa
Date/time Date format DD-MM-YYYY

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3. Menu structure and setup programs TCM4/40 operator's manual

3-26
 4. Installation and maintenance

Operating requirements.............................................................................................4-2
Installing the monitoring system...............................................................................4-3
Shutting down the monitor........................................................................................4-5
Cleaning the monitor.................................................................................................4-6
Maintenance of the monitor ......................................................................................4-7
Preparation and maintenance of the tc sensors....................................................4-9
General information about remembraning ..............................................................4-10
Cleaning the sensor head of the E5480 sensor........................................................4-11
Membraning the E5480 sensor................................................................................4-12
Membraning the E5280 and E5260 sensors............................................................4-13
Cleaning, disinfection and storage of sensors .........................................................4-15
Maintenance of the SpO2 sensors.........................................................................4-16
4. Installation and maintenance TCM4/40 operator's manual

Operating requirements

WARNING – Risk of incorrect measurements

Do not use the monitor adjacent to or stacked with other equipment as
these can cause electromagnetic interference and thereby result in
incorrect measurements. If stacking or use adjacent to other equipment is
necessary, the monitor should be observed to verify normal operation
before used on patients. See the section EMC approvals and compliance
in chapter 8.
WARNING – Risk of incorrect measurements
When installing, operating or servicing the monitor, special consideration
should be given to the information regarding the electromagnetic
precautions for this equipment given in the section EMC approvals and
compliance in chapter 8. Otherwise the monitor may be affected by
electromagnetic interference, causing incorrect measurements.
WARNING – Risk of fire
Do not place the monitor in an enriched oxygen atmosphere or inside a
hyperbaric chamber as it may cause a fire hazard.
WARNING – Risk of explosion
Do not use the monitor in the presence of flammable anesthetics or gases
as it may cause an explosion.
WARNING – Risk of fire
Do not cover the ventilator as this may cause it to seize up.
WARNING – Risk of electrical shock
Do not use the monitor if it is damaged as this may result in electrical
shock.

Environmental The following environmental requirements must be observed at all times:

requirements
• ambient temperature: 5-40 °C
• relative humidity: 20-80 %.

NOTICE: Do not operate the monitor at ambient temperatures below 5 °C or above

40 °C and relative humidity below 20 % or above 80 %. Operating the monitor
outside these limits may affect the readings of the device.

Ventilation The monitor must be located in a well-ventilated dust-free atmosphere.

requirements

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TCM4/40 operator's manual 4. Installation and maintenance

Installing the monitoring system

Procedure Step Action

1. NOTICE: While installing the modules, the monitor must be turned
off.
Install the relevant module(s) (i.e. tc and SpO2) by pressing each
module completely into the base unit until a click is heard.
NOTICE: If using an E5480 sensor, the gasket in the calibration
chamber must be code no. 837-488; and if using an E5280 or E5260
sensor, the gasket in the calibration chamber must be code no. 837-
159 (see package insert for instructions).
2. For TCM40 monitor only: Plug the SpO2 sensor into the monitor.
NOTICE: It is not necessary for the monitor to be turned off while
the sensor is being connected.
3. Install the calibration gas cylinder and the battery according to the
procedures described later in this chapter under Maintenance of the
monitor.
4. Connect the monitor power cord to
• the power socket at the rear of the monitor and
• an appropriate power supply
5. Connect the system to external equipment, if required.

WARNING – Risk of personal injury

Before connecting other equipment to the TCM monitor, the
manufacturer of the equipment or a qualified engineer must be
consulted to ensure that the equipment is compatible and that
the safety of the patient, the operator or the environment will
not be impaired. The resulting combined system must comply
with EN 60601-1-1.
6. Turn on the monitor by pressing the power switch to the ON position
at the rear of the monitor and then pressing the ON/OFF button on the
front of the monitor.
NOTICE: Every time the monitor is turned on, a beep sounds,
indicating that it has been checked that the sound of the alarm system
is working. If the sound is not working, an error message is shown.
7. Check that the date and time in the display correspond with the actual
date and time. Otherwise correct them in Technical setup.
8. Membrane the tcpCO2/tcpO2 sensor as described later in this chapter.
9. Connect the tcpCO2/tcpO2 sensor plug to the sensor socket at the rear
of the tc module, and place the sensor in the calibration chamber at the
front.

Continued on next page

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4. Installation and maintenance TCM4/40 operator's manual

Installing the monitoring system, Continued

Procedure Step Action

(continued)
10. Check that the tc module is functioning: The message "Calibration
required" is displayed on the screen. Leave it until step 12.
11. Change View or Setup settings, if required, by pressing Setup. See
chapter 3: Menu structure and setup programs.
NOTICE: The monitor is delivered with default settings (see these in
the section Default values in chapter 3).
12. Calibrate the sensor as described in chapter 5: Calibration.

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TCM4/40 operator's manual 4. Installation and maintenance

Shutting down the monitor

Shutting down Step Action

the monitor
1. Press the button on the front of the monitor.
The following system message will be displayed:

2. Press OK to shut down the monitor – the message "Saving data. Please
wait." will be displayed – or Cancel to return to the main screen
without shutting down the monitor.

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4. Installation and maintenance TCM4/40 operator's manual

Cleaning the monitor

Cleaning the When cleaning the monitor:

exterior
• Shut down the monitor by following the procedure described earlier in this chapter
• Use a cloth that is lightly dampened with soapy water
• Do not use abrasive cleansers or pads: the finish may become damaged
• Do not use aggressive detergents. Extensive use may cause the plastic to become
brittle and cracks may occur.

Cleaning the A dry or lightly dampened soft, lint-free cloth may be used to clean the monitor's
touch screen touch screen. Simply wipe the screen gently to remove fingerprints and/or dirt. To
avoid streaking, an approved screen cleaner is recommended.

Disinfection of Disinfection of the monitor exterior and touch screen is performed when appropriate.
outer surfaces The disinfection frequency depends on local requirements and the use of the monitor.
NOTICE: Follow legal requirements and local rules for safe work practices with
chemicals.
The following disinfectants, dissolved in water, may be used to disinfect the monitor
exterior and touch screen:
• 70 % isopropyl alcohol
• 70 % ethanol
• 4 % Diversol BX solution
To disinfect the monitor exterior and touch screen, wipe the surfaces using one of the
above disinfectants on a paper towel or tissue.
NOTICE Do not spray, pour or spill any liquid on the monitor or any of the accessories,
connectors, switches or openings in the chassis.

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TCM4/40 operator's manual 4. Installation and maintenance

Maintenance of the monitor

Battery The following battery type must be installed on the monitor: Standard 12 V 2 Ah
lead-acid battery (code no. 431-018, available from Radiometer)
Contact your local battery supplier for available type.

CAUTION – Risk of patient not being monitored

For data safety reasons, a battery must always be connected to the system.
CAUTION – Risk of patient not being monitored
Replace battery only with the types recommended by Radiometer.
CAUTION – Handling of biohazardous waste
Dispose of the battery according to local procedures to avoid personal
injury or pollution of the environment.

The monitor can function for approx. one hour on battery supply (depending on
battery type). When the monitors run on battery, it is indicated on the display, and
the battery level indicator shows the battery level. If the battery level is low, an alert
sound is heard and the battery level indicator is flashing. If the battery level is
critically low, an alert message will furthermore be displayed.

CAUTION – Risk of patient not being monitored

Make sure the battery level never becomes critically low, as this will
prevent data from being saved onto the disk.

To avoid a complete discharge of the battery, reconnect the monitor to the mains as
soon as possible to recharge the battery. Recharging the battery takes approximately 8
hours.

Changing the Step Action

battery
1. Unscrew the battery cover at the rear of the monitor.
2. Detach the battery from the connector.
3. Attach a new battery to the connector.
4. Reattach the battery cover.

Continued on next page

4-7
4. Installation and maintenance TCM4/40 operator's manual

Maintenance of the monitor, Continued

Changing the Step Action

calibration gas
1. Unscrew the old calibration gas cylinder.
WARNING – Risk of explosion
Calibration gas cylinder: Contents under pressure. Do not
puncture. Do not use or store near heat or open flame. Exposure
to temperatures above 54 °C (for CAL2) and 50 °C (for CAL1)
may cause contents to vent or cause bursting. Never discard
container into fire or incinerator as it may cause an explosion.
2. Screw the new calibration gas cylinder clockwise as far as possible
into the socket.
NOTICE: Excessive force may damage threads and result in a
leakage and thereby an increase in consumption.

Changing the Step Action

gasket in the
1. Remove the gasket from the calibration chamber.
calibration
chamber 2. Clean the calibration chamber with a soft cloth moistened with skin
antiseptic, e.g. 70 % alcohol.
3. Mount a new gasket into the calibration chamber.
NOTICE: Be sure to align the gasket correctly.

4-8
TCM4/40 operator's manual 4. Installation and maintenance

Preparation and maintenance of the tc sensors

General information about membraning ................................................................ 4-10

Cleaning the sensor head of the E5480 sensor....................................................... 4-11
Membraning the E5480 sensor............................................................................... 4-12
Membraning the E5280 and E5260 sensors........................................................... 4-13
Cleaning, disinfection and storage of sensors ........................................................ 4-15

4-9
4. Installation and maintenance TCM4/40 operator's manual

General information about membraning

To obtain reliable measurements, remembrane the sensor every week.

WARNING – Risk of incorrect measurements (sensor failure)

After remembraning the sensor, check that the membrane has been clicked
completely and centrally onto the sensor housing. Otherwise it may cause
the sensor to fail.

When a sensor has been remembraned, connect the sensor plug to the sensor socket
at the rear of the monitor. Check that the system shows "Calibration required" and
calibrate the sensor twice as described in chapter 5: Calibration.

4-10
TCM4/40 operator's manual 4. Installation and maintenance

Cleaning the sensor head of the E5480 sensor

Cleaning the NOTICE: Once a month, the sensor head must be cleaned to remove old electrolyte
sensor head before the sensor is remembraned.

Step Action
1. Slide the sensor into the end of the membraning
tool.

2. Pull the sensor upwards to remove the

membrane.

3. Clean the sensor head with cleaning paper and

remembrane the sensor as described on next
page.

4-11
4. Installation and maintenance TCM4/40 operator's manual

Membraning the E5480 sensor

Membraning To membrane the sensor, use a membraning kit (code no. 905-805).
the sensor
Step Action
1. Apply two drops of electrolyte solution to the
membraning tool.
NOTICE: Ensure that there are no air bubbles
in the electrolyte solution. If air bubbles are
present, wait a few seconds and check again.

2. Place the sensor (without the protection cap) in

the sensor slot.

3. a) To remove the old membrane, grip the

membraning tool firmly at both ends.

b) Pull in the direction of the arrows until only

one arrow is visible in the sensor slot.

4. To click on the new membrane, pull forcefully

in the direction of the arrows until the tool locks
and no arrows are visible in the sensor slot.

5. Remove the sensor and wipe off the surplus

electrolyte solution with cleaning paper.

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TCM4/40 operator's manual 4. Installation and maintenance

Membraning the E5280 and E5260 sensors

Membraning the To membrane the sensor, use a membraning kit (code no. 904-892).
sensor
Step Action
1. Remove the protection cap.
Then remove the old O-rings by sliding the
O-ring remover under the O-ring, just above the
arrow on the sensor house.

2. Turn the O-ring remover clockwise to release

the two O-rings.

3. Peel off the old membranes.

4. Clean the sensor surface:

Absorb the old electrolyte solution with the
cleaning paper.

5. Rub the sensor measuring surface carefully two

or three times to remove the thin layer of silver
that has precipitated on the sensor.

6. Apply two drops of the tcpCO2/tcpO2 electrolyte

solution on the surface of the sensor.
NOTICE: Check that the electrolyte solution
covers the entire surface without air bubbles.

Continued on next page

4-13
4. Installation and maintenance TCM4/40 operator's manual

Membraning the E5280 and E5260 sensors, Continued

Membraning the Step Action

sensor
(continued)
7. • Place the membrane unit on a hard and stable
surface.
• Turn the sensor slowly so that the measuring
surface faces downwards.
• Insert the sensor head into the top of the green
membrane unit.
8. • Press the sensor firmly into the unit until a
click is heard.
• Remove the sensor from the unit and wipe off
the surplus electrolyte solution with the
cleaning paper.

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TCM4/40 operator's manual 4. Installation and maintenance

Cleaning, disinfection and storage of sensors

Cleaning the Wipe the following parts gently with a soft cloth moistened with skin antiseptic, e.g.
sensors 70 % alcohol:
• the sensor head
• the cable
NOTICE: Constant use of hand lotion containing isopropanol/propylalcohol and
alcohol prior to handling the sensor may damage the cable. To avoid transferring lotion
to the cable, dry hands prior to handling the sensor.

Disinfection WARNING – Risk of infection

Due to the nature and seriousness of diseases such as the Human
Immunodeficiency Virus (HIV) (the causative agent of AIDS) and
Hepatitis B, always regard equipment and accessories that can come into
contact with human or animal tissues or fluids (particularly blood) as
contaminated and potentially hazardous to avoid the risk of infection.
Disinfection of the sensor is carried out with a membraned sensor and normally prior
to calibration.
Disinfection of the sensor and the cable can be carried out by immersing the sensor
and the cable in a water-based disinfection solution, such as a germicidal water-
based solution (e.g. one based on n-alkyl dimethyl benzyl ammonium chloride with
isopropanol).
WARNING – Risk of incorrect measurements (sensor failure)
Do not immerse the sensor plug in disinfection solution. Immersing the
sensor plug in disinfection solution will cause the sensor to fail.
WARNING – Risk of incorrect measurements (sensor failure)
Do not heat sterilize as the sensor cannot tolerate temperatures exceeding
70 °C. Heat sterilization of the sensor will cause it to fail.

As the number of disinfection solutions is increasing and may vary from country to
country and from hospital to hospital, it is not possible to come up with a complete
list of water-based disinfection solutions that may be used.
However, Radiometer proposes that one of the following water-based disinfection
solutions is used:
• MadaCide-FD (MADA Inc.)
• Control III (Maril Products Inc.)
• Hi-Tor Plus (Ecolab Inc.)
• 3.2 % aqueous glutaraldehyde solution (Surgikos - Johnson & Johnson Medical)
Solutions solely based on isopropanol/propylalcohol should be avoided as frequent
use of isopropanol/propylalcohol may damage the electrode cable.
NOTICE: To establish the correct disinfection procedure for your hospital, it is
important that you consult the hygiene committee at your hospital.

Storage You may keep the sensors stored in the calibration chambers. For longer periods of
storage, keep the sensors mounted with a protective cap.
NOTICE: Add two drops of electrolyte solution to the cap.

4-15
4. Installation and maintenance TCM4/40 operator's manual

Maintenance of the SpO2 sensors

Cleaning the The SpO2 sensors may be surface-cleaned with a solution such as 70 % isopropyl
SpO2 sensors alcohol. If low-level disinfection is required, use a 1:10 bleach solution. Do not use
undiluted bleach (5-5.25 % sodium hypochlorite) or any cleaning solution other than
those recommended here because permanent damage to the sensor could occur.
WARNING – Risk of incorrect measurements (sensor failure)
Do not expose connector pins to cleaning solution as this may damage the
SpO2 sensor.
WARNING – Risk of incorrect measurements (sensor failure)
Do not sterilize the SpO2 sensor by irradiation, steam or ethylene oxide as
this may damage the sensor.

There are two recommended cleaning/disinfection methods:

• The wipe method (for all three SpO2 sensors)
• The soak method (for Oxiband A/N and P/I sensors only)

Wipe method Step Action

procedure
1. Saturate a clean, dry gauze pad with the cleaning solution. Wipe all
surfaces of the sensor and cable with this gauze pad.
2. Saturate another clean, dry gauze pad with sterile or distilled water.
Wipe all surfaces of the sensor and cable with this gauze pad.
3. Dry the sensor and cable by wiping all surfaces with a clean, dry
gauze pad.

Soak method For Oxiband A/N and P/I sensors only.

procedure
WARNING – Risk of incorrect measurements (sensor failure)
Do not immerse or wet the DS100A sensor as this may damage the sensor.

Step Action
1. Place the sensor in the cleaning solution, such that the sensor head(s)
and desired length of cable are completely immersed.
WARNING – Risk of incorrect measurements (sensor failure)
Do not immerse the connector end of an SpO2 sensor cable as
this may damage the sensor.
2. Dislodge air bubbles by gently shaking the sensor and cable.
3. Soak the sensor and the cable for 10 minutes.
4. Remove from cleaning solution.
5. Place the sensor and the cable in room-temperature sterile or distilled
water for 10 minutes.
6. Remove from the water.
7. Dry the sensor and cable by wiping all surfaces with a clean, dry gauze
pad.

4-16
 5. Calibration

General information ................................................................................................. 5-2

Calibration................................................................................................................ 5-3
Checking zero current and sensitivity ...................................................................... 5-4
5. Calibration TCM4/40 operator's manual

General information

To ensure accurate and safe performance of the sensor, it must be calibrated

according to the recommendations below.
Calibration To calibrate the sensor, use the CAL1 standard calibration gas mixture (7.5 % CO2,
material 20.9 % O2, balance N2).

SmartCal The SmartCal function makes sure that the monitor is always ready by calibrating
when needed for a period of time that is defined by the operator (1-12 hours or
forever).

Calibration SmartCal Explanation

frequency
ON If SmartCal is ON and the duration is set to forever or 1-12
hours, a calibration will be performed automatically every
4 hours (i.e. whenever the sensor is placed in the
calibration chamber and within the selected SmartCal
period).
NOTICE: If the duration is set to 1-12 hours, it will be
necessary to press Calibrate to start a new SmartCal period
after the first period ended.
OFF If SmartCal is OFF, Radiometer recommends performing a
manual calibration:
• every time the sensor has been remembraned
• prior to each monitoring period
• when changing measuring sites
• every 4 hours
NOTICE: If the sensor was not in use for an extended
time period, it is recommended to select SmartCal ON and
to allow at least 4 hours for stabilization of the sensor in
the calibration chamber.

Recommen- Check the barometer of the monitor against a known calibrated barometer
dation periodically. See ranges in chapter 8: Specifications and ordering information.

5-2
TCM4/40 operator's manual 5. Calibration

Calibration

Calibrating the If the SmartCal function is OFF, the sensor must be calibrated manually using the
sensor manually procedure below.
WARNING – Risk of incorrect measurements
When performing a gas calibration, make sure the calibration gas mixture
is set to 7.5 % for pCO2 and 20.9 % for pO2 as incorrect calibration values
may cause incorrect measurements.

See Technical settings in chapter 3: Menu structure and setup programs.

Step Action
1. Make sure the sensor is placed in the calibration chamber.
2. Press Calibrate.
A bar appears on the screen, showing the progress of the calibration.
Furthermore, the screen contains information on barometric pressure
and, if there is 10 % or less gas left in the gas cylinder, a bar will show
the gas level.
NOTICES:
• If SmartCal has been activated in the setup, pressing the Calibrate
touch key will start the SmartCal period.
• During calibration it is not possible to reactivate the Calibrate
touch key, which will be grayed out.
3. When the calibration is complete, the Ready screen appears.

NOTICES • If the sensor has been remembraned or if it has not been used for 24 hours or
more, it must be calibrated twice. Either calibrate the sensor, leave it in the
calibration chamber for 30 minutes and then calibrate it again; or enable the
SmartCal function, press Calibrate and then leave the sensor in the calibration
chamber for 30 minutes.
• If SmartCal is OFF and the sensor is not removed from the calibration chamber
within 30 minutes after Ready, the heat to the sensor will be switched off and a
new calibration will be required.

5-3
5. Calibration TCM4/40 operator's manual

Checking zero current and sensitivity

Recommen- The zero current of pO2 and the sensitivity of pCO2 should be checked if the sensor
dations performance appears to deteriorate.

Items required The following items are required:

• CAL2 standard calibration gas (10 % CO2 with N2 as balance)
• Gas adapter for CAL2 gas

Checking pO2 Step Action

zero current and
1. Before calibrating the sensor, set the metabolic correction factor to
pCO2 sensitivity
zero and the Severinghaus correction factor to "OFF" in the Technical
setup.
2. Calibrate the sensor.
3. Attach the adapter to the CAL2 gas cylinder and place the sensor in
the calibration chamber of the gas adapter.
4. The pCO2 reading is displayed on the screen. It should be within
73-79 mmHg (9.7-10.5 kPa) within 10 minutes after the sensor has
been placed in the calibration chamber of the gas adapter.
5. Read the tcpO2 value on the screen:
• If under 5 mmHg (0.7 kPa), the sensor is in good condition.
• If equal to or above 5 mmHg (0.7 kPa), the sensor must be
remembraned and recalibrated. Then repeat steps 1-3 of this
procedure.
NOTICE: If the tcpO2 reading is still equal to or above 5 mmHg
(0.7 kPa), the sensor is defective.
6. After zero current and sensitivity have been checked, unscrew the
CAL2 gas cylinder from the gas adapter.
7. Remember to reset the metabolic correction factor to "7" and the
Severinghaus correction factor to "ON" in the Technical setup.
NOTICE: Lack of sensitivity may be due to insufficient removal of used
electrolyte solution during the membraning procedure. In such cases, it is
recommended to remembrane the sensor according to the procedure described in
chapter 4: Installation and maintenance.

5-4
 6. Patient monitoring

General information ................................................................................................. 6-2

Application and removal of tc sensors ..................................................................... 6-6
Application of SpO2 sensors .................................................................................... 6-8
Patient monitoring (In vivo monitoring) ................................................................ 6-11
Patient DMS........................................................................................................... 6-13
Results in Normal view.......................................................................................... 6-16
Results in Trend table view.................................................................................... 6-18
Results in Trend curve view................................................................................... 6-19
Analog output......................................................................................................... 6-21
Continuous data output: standard........................................................................... 6-22
Continuous data output: VueLink .......................................................................... 6-24
Continuous data output: MonLink ......................................................................... 6-29
Data export: serial .................................................................................................. 6-30
Data export: USB ................................................................................................... 6-33
Alarms.................................................................................................................... 6-34
How to print ........................................................................................................... 6-38
Blood gas comparison ............................................................................................ 6-44
In vivo calibration .................................................................................................. 6-45
6. Patient monitoring TCM4/40 operator's manual

General information

Measuring sites tcpCO2/tcpO2 measurements:

Clinical studies have shown the abdomen and chest to be the best measuring sites
for both neonates and adults.

Saturation measurements:
• Nellcor Durasensor DS100A sensor:
• Patient (> 40 kg): The preferred site is the index finger, or alternatively a
smaller finger, but not the thumb.
• Nellcor Oxiband A/N sensor:
• Adult (> 40 kg): The preferred site is around an index finger, with the
cable positioned along the top of the finger. Alternatively, use a thumb or
another finger, with the cable positioned along the palm; or around a great
toe, with the cable positioned along the sole of the foot.
• Neonate (< 3 kg): The preferred site is the foot, below the toes, with the
cable positioned along the sole of the foot. Alternatively, place the sensor
around the palm of a hand, below the fingers, with the cable positioned
along the palm.
• Nellcor Oxiband P/I sensor:
• Pediatric (15-40 kg): The preferred site is around an index finger, with the
cable positioned along the top of the finger. Alternative sites are around
the thumb or another finger, with the cable positioned along the top of the
finger; or a great toe, with the cable positioned along the sole of the foot.
• Infant (3-15 kg): The preferred site is around a great toe, with the cable
positioned along the sole of the foot.
NOTICE: The monitor must only be connected to sensors for one patient at a time.

tcpCO2/tcpO2 For neonates, a sensor temperature between 42 and 44 °C is recommended.

sensor
temperature For adults, a sensor temperature between 43 and 45 °C is recommended.
WARNING – Risk of burns
Do not allow the tcpCO2/tcpO2 sensor temperature to exceed 43 °C for
neonates and 44 °C for adults if sensors are attached to skin for more than
four hours as this may otherwise cause burns.

General alerts WARNING – Risk of incorrect measurements

Do not use the sensors during MRI scanning. Conducted current may
cause burns. Also, the sensors may affect the MRI image, and the MRI
unit may affect the accuracy of oximetry measurements.
WARNING – Risk of strangulation
As with all medical equipment, carefully route and affix patient cabling
using the cable clip to reduce the possibility of patient entanglement or
strangulation.
WARNING – Risk of skin damage
To avoid the risk of skin damage, make sure to set SmartHeat to OFF
before applying the sensor to a neonate.

Continued on next page

6-2
TCM4/40 operator's manual 6. Patient monitoring

General information, Continued

General alerts WARNING – Risk of incorrect measurements

(continued) Remove the sensors from the patient immediately if the system or patient
is exposed to a defibrillator, electrocautery or other high-frequency
electrical signals, as these may affect the device and may cause injury to
the patient.
WARNING – Risk of fire
Do not place the monitor in an enriched oxygen atmosphere or inside a
hyperbaric chamber as it may cause a fire hazard.
WARNING – Risk of personal injury
Make sure to select the upper alarm limit for oxygen saturation carefully
and in accord with accepted clinical standards. High oxygen levels may
predispose a premature infant to develop retinopathy.
WARNING – Risk of skin damage
Long-term hyperthermia may blister skin. When producing local
hyperemia by means of hyperthermia, a certain risk of applying
temperatures harmful to the skin is always present, although the risk is
limited due to the control system of the instrument. Always pay attention
to the use of hyperthermia for special patients – e.g. patients in shock,
patients with low blood pressure, and patients with vascular constrictions.
WARNING – Risk of bruises
When applying a fixation ring to a patient, make sure to place it so that the
patient does not lie on top of it, as this may cause the fixation ring to leave
bruises on the patient.
WARNING – Risk of incorrect measurements
Always keep protection caps on the tcpCO2/tcpO2 sensors (except when
applied to skin, placed in the calibration chamber or during handling and
maintenance). Exposing sensor membranes to light (for example light
from incubators) may cause elevated pCO2 values.
WARNING – Risk of incorrect measurements
Do not use the monitor adjacent to or stacked with other equipment as
these can cause electromagnetic interference and thereby result in
incorrect measurements. If stacking or use adjacent to other equipment is
necessary, the monitor should be observed to verify normal operation
before used on patients. See the section EMC approvals and compliance
in chapter 8.
WARNING – Risk of incorrect measurements
When installing, operating or servicing the monitor, special consideration
should be given to the information regarding the electromagnetic
precautions for this equipment given in the section EMC approvals and
compliance in chapter 8. Otherwise the monitor may be affected by
electromagnetic interference, causing incorrect measurements.
WARNING – Risk of incorrect measurements
The use of sensors, cables and accessories other than those specified may
result in increased emission and/or decreased immunity and inaccurate
readings of the monitor.

Continued on next page

6-3
6. Patient monitoring TCM4/40 operator's manual

General information, Continued

General alerts WARNING – Risk of incorrect measurements
(continued) tcpCO2/tcpO2 monitoring should not be used on patients in a compromised
hemodynamic state as this may cause incorrect measurements.
WARNING – Risk of incorrect measurements
Using the SpO2 sensors in the presence of high ambient light may result in
inaccurate measurements. In such cases, cover the sensor site with an
opaque material.
WARNING – Risk of incorrect measurements
Remove any intravascular dyes or externally applied coloring such as nail
polish, dye or pigmented cream as they may lead to inaccurate pulse
oximetry measurements.
WARNING – Risk of incorrect measurements
Pulse oximetry readings and pulse signal can be affected by certain
ambient environmental conditions, sensor application errors and certain
patient conditions. See the appropriate sections of the manual for specific
safety information.
WARNING – Risk of incorrect measurements
Always select the measuring site carefully to avoid selecting a site with
low perfusion or low signal quality, which can cause incorrect
measurements.
WARNING – Risk of patient not being monitored
Do not use a NIBP cuff or other constricting devices on the same
appendage as the sensor. A NIBP cuff will interrupt the patient's
circulatory blood flow and result in no pulse found or loss of pulse.

TCM40 Certain patient conditions can affect the measurements of the monitor and cause
performance the loss of the pulse signal.
considerations Inaccurate measurements can be caused by:
• prolonged patient movement
• venous pulsations
• intravascular dyes, such as indocyanine green or methylene blue
• defibrillation

Dysfunctional hemoglobins such as carboxyhemoglobin, methemoglobin, and

sulfhemoglobin are unable to carry oxygen. SpO2 readings may appear normal;
however, a patient may be hypoxic because less hemoglobin is available to carry
oxygen. Further assessment beyond pulse oximetry is recommended.
Anemia causes decreased arterial oxygen content. Although SpO2 readings may
appear normal, an anemic patient may be hypoxic. Correcting anemia can improve
arterial oxygen content. The monitor may fail to provide an SpO2 if hemoglobin
levels fall below 5 g/dL.
Saturation: The monitor displays saturation levels between 1 and 100 %.
Pulse rates: The monitor displays pulse rates between 20 and 300 beats per
minute. Detected pulse rates outside the range of 20 to 300 beats per minute are
displayed as the closest value within the range.
Continued on next page

6-4
TCM4/40 operator's manual 6. Patient monitoring

General information, Continued

SpO2 sensor Inaccurate measurements may be caused by:

performance
considerations • incorrect application of the sensor
• placement of the sensor on an extremity with a blood pressure cuff, arterial
catheter, or intravascular line
• ambient light
• prolonged patient movement

Loss-of-pulse signal can occur for the following reasons:

• The sensor is applied too tightly
• A blood pressure cuff is inflated on the same extremity as the one with the
sensor attached
• There is arterial occlusion proximal to the sensor
Use only Radiometer-recommended sensors and sensor cables.

Select an appropriate sensor, apply it as directed and observe all warnings and
cautions presented in the directions for use accompanying the sensor. Clean and
remove any substances such as nail polish from the application site. Periodically
check to ensure that the sensor remains properly positioned on the patient.
WARNING – Risk of skin damage
Inspect the sensor site as directed in the sensor directions for use.
Incorrect application or inappropriate duration of use of an SpO2 sensor
can cause skin damage.
WARNING – Risk of incorrect measurements
Make sure the sensor is applied correctly. Incorrect application of the
SpO2 sensor can cause incorrect measurements.

High ambient light sources such as surgical lights (especially those with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct
sunlight can interfere with the performance of an SpO2 sensor. To prevent
interference from ambient light, ensure that the sensor is properly applied and
cover the sensor site with opaque material.
If patient movement presents a problem, try one or more of the following remedies
to correct the problem:
• Verify that the sensor is properly and securely applied
• Move the sensor to a less active site
• Use an adhesive sensor that tolerates some patient motion
• Use a new sensor with fresh adhesive backing

6-5
6. Patient monitoring TCM4/40 operator's manual

Application and removal of tc sensors

Required The following items, included in the fixation kits, are required to apply the tc
materials for sensors to a patient:
application of • Fixation ring
sensors
WARNING – Risk of infection and inaccurate results
Reuse of single-use devices may lead to infection of patients and inaccurate
results.
• Contact liquid

Prior to sensor Step Action

application
1. Calibrate the sensor as described in chapter 5: Calibration.
2. Clean the selected measuring site with alcohol or other skin-
preparation solution.
3. Dry the site well with a gauze pad.

Application of Step Action

E5480 sensor
1. Take a fixation ring and remove the protective
film.
2. Apply the fixation ring to clean and dry skin by
pressing the center of the fixation ring onto the
measuring site with a finger and then running a
finger around the rim circumference to ensure a
good seal.

3. Apply 2 drops of contact liquid in the center of

the ring.

4. Place the sensor (without the protection cap) in

the fixation ring with the sensor cord pointing in
the opposite direction of the tab on the ring.
Then turn the sensor a quarter of a turn
clockwise to fasten it in the fixation ring.

Continued on next page

6-6
TCM4/40 operator's manual 6. Patient monitoring

Application and removal of tc sensors, Continued

Application of Step Action

E5280 and
1. Take a fixation ring and remove the protective
E5260 sensors
film.
2. Apply the fixation ring to the measuring site by
pressing the center of the fixation ring onto the
measuring site with a finger and then running a
finger around the rim circumference.
NOTICE: Press firmly to prevent leaks.
3. Fill the center of the fixation ring with 3-5 drops
of the contact liquid.

4. Remove the sensor from the calibration

chamber, align the arrow on the sensor with one
of the marks on the fixation ring and turn the
sensor a quarter of a turn clockwise to fasten it
in the fixation ring.

Removal of Step Action

sensor
1. Remove the sensor from the fixation ring by turning it anticlockwise.
2. Remove the fixation ring by lifting the tab.
3. Clean the sensor surface carefully with an alcohol swab.
4. Then place the sensor in the calibration chamber.

6-7
6. Patient monitoring TCM4/40 operator's manual

Application of SpO2 sensors

Required Saturation monitoring is only available on the TCM40 monitor.

materials for
The following items are required to apply an SpO2 sensor to a patient:
SpO2
monitoring • Nellcor SpO2 sensor
• Adhesive wrap model ADH-A/N or FOAM-A/N (for Oxiband A/N and Oxiband
P/I sensors)
• Nellcor DOC-10 pulse oximetry cable

WARNING – Risk of incorrect measurements

Use only Nellcor oximetry brand SpO2 sensors and sensor cables. And
before use, carefully read the sensor directions for use, including all
warnings, cautions and instructions. Incorrect use can cause incorrect
measurements.
WARNING – Risk of incorrect measurements
Use only the DOC-10 pulse oximetry cable and do not increase the length
of the sensor by connecting an extra sensor cable. Use of another sensor
cable or more than one cable will have an adverse effect on performance.
WARNING – Risk of skin damage
Use only Nellcor oximetry brand wraps designed for use with the SpO2
sensor. Do not use tape. Use of additional tape or various other types of
wraps can cause skin damage.

NOTICES:
• Radiometer provides a starter kit containing sensor (Nellcor DS100A, Nellcor
Oxiband A/N or Nellcor Oxiband P/I), wraps and cable. New sensors (or other
Nellcor sensors than the one in the starter kit), wraps and cables must be ordered
from your local Nellcor agent.
• When selecting an SpO2 sensor, consider the patient’s weight and activity level,
the adequacy of perfusion and the available sensor sites, the need for sterility
and the anticipated duration of monitoring.
• When selecting a sensor site, priority should be given to an extremity free of an
arterial catheter, blood pressure cuff or intravascular infusion line.
• Before applying the sensor, clean and remove any substances, such as nail
polish, from the application site.

Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

Application of SpO2 sensors, Continued

Application of Step Action

DS100A sensor
1. Place the patient’s index finger over the sensor
window of the DS100A sensor with the fingertip
against the stop.

2. If the fingernail is long, the nail tip will extend

over the finger stop.

3. Spread open the rear tabs of the sensor to provide

even force over the length of the pads. Check the
position of the sensor. If an index finger cannot
be positioned correctly, or is not available, a
smaller finger can be used, or use another sensor.
NOTICE: Do not use the DS100A on a thumb or
toe or across a child’s hand or foot.
4. The sensor should be oriented in such a way that
the cable is positioned along the top of the hand.

Application of Step Action

Oxiband A/N
1. Place the wrap on a flat surface, adhesive (sticky)
and P/I sensors
side up, with the tab on the left.
2. Remove the small piece of paper backing and
enough of the large piece of backing to expose
both alignment holes.
3. Position the sensor on the wrap so the alignment
bumps protrude through the holes. Press down
firmly in the center of the sensor to ensure that
the wrap adheres tightly.
4. Remove the remainder of the paper backing from
the wrap. The sensor and wrap are now ready to
be applied to the patient. Select an appropriate
site as described previously in this chapter under
General information.

Continued on next page

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Application of SpO2 sensors, Continued

Application of
Step Action
Oxiband A/N
and P/I sensors 5. Position the sensor so that the notches are
(continued) centered on the side of the measuring site.
The cable end must be positioned along the
appropriate surface, as described previously in
this chapter under General information.
6. Wrap the sensor around the measuring site so the
optical components (and alignment bumps)
oppose each other across the site. Press the
sensor to ensure that it adheres snugly.
7. Wrap the remaining portion of the sensor wrap
around the site, loosely enough to ensure good
circulation.

Removal of The disposable wraps used with the Oxiband A/N and P/I sensors should be
wraps removed by peeling them away from the sensor.

WARNING – Risk of sensor damage

Do not use excessive force when removing the disposable wrap from the
sensor, as it may damage the sensor.

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Patient monitoring (In vivo monitoring)

Patient Step Action

monitoring
1. Apply the sensor(s) as described earlier in this chapter and wait for a
stable reading.
NOTICES:
• The physiological stabilization time of a patient is 10-20 minutes for
the tcpO2 reading. Longer time may indicate incorrect sensor
application or a poorly selected measuring site.
• The physiological stabilization time of a patient is 5-10 minutes for
the tcpCO2 reading. Longer time may indicate incorrect sensor
application or a poorly selected measuring site.
• Excessive motion may compromise performance. In such cases, try
to keep the patient still or change the sensor site to one with less
motion.
• If SmartHeat is set to ON, it adds +1 °C (max. temp. 45 °C) to the
set sensor temperature for 5 minutes after the sensor has been
removed from the calibration chamber.
• If the SpO2 sensor does not track the pulse reliably, it may be
incorrectly positioned or the sensor site may be too thick, thin or
deeply pigmented, or otherwise deeply colored (for example as a
result of externally applied coloring such as nail polish, dye or
pigmented cream) to permit appropriate light transmission. If any of
these situations occurs, reposition the sensor or choose an alternate
sensor for use on a different site.
• The visual indication of the plethysmograph curve is not
proportional to the pulse volume.
2. Press Site time to reset the site timer to the value selected in Parameter
setup, if required. The site timer applies to tcpCO2/tcpO2 only.
NOTICES:
• The site timer will count down to zero at 1-minute intervals, and
when it reaches zero, the message "Site time end" will be displayed
on the screen.
• If Site time heat is set to OFF in the setup, the sensor heat is
switched off when the site timer reaches zero and the monitor stops
monitoring; if set to ON, the heat continues.
3. To mark an event, press Event. The text "Set event mark number x?"
will be displayed.
Press OK to mark the event, or press Cancel to return to Normal view
without marking the event.
NOTICE: It is possible to mark up to 99 events.

Continued on next page

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Patient monitoring (In vivo monitoring), Continued

Patient
Step Action
monitoring
(continued) 4. To link the session (i.e. the measurement in progress) to a specific
patient ID, press ID in the top right corner of the view screens and make
the necessary changes in the Patient DMS. For more information, see
Patient DMS later in this chapter.
5. View the readings and adjust the settings, if necessary. See chapter 3:
Menu structure and setup programs.
WARNING – Risk of skin damage
Sensors must be moved to a new site at least every four hours.
Because individual skin condition affects the ability of the skin to
tolerate sensor placement, it may be necessary to change the
sensor site more frequently with some patients. If skin integrity
changes, move the sensor to another site.
WARNING – Risk of incorrect measurements
Always keep protection caps on the tcpCO2/tcpO2 sensors (except
when applied to skin, placed in the calibration chamber or during
handling and maintenance). Exposing sensor membranes to light
(for example light from incubators) may cause elevated pCO2
values.
NOTICE: After removing the sensor from the patient, make sure to
wipe it clean from contact liquid before placing it in the calibration
chamber.

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Patient DMS
The Patient DMS (Data Management System) manages all session/patient ID data,
and it helps avoiding the risk of patient data mix-up.
From the Patient DMS screen it is possible to:
• change the automatically generated session number to a unique patient ID
• view data from one or more sessions with the same ID in the Trend table or
Trend curve view
• print one or more sessions
• export one or more sessions
• delete sessions
• see detailed information about a session

Session A session is a collection of data starting when the sensor is removed from the
calibration chamber and ending when the sensor is placed back in the calibration
chamber.
Each session gets a unique number, which can be linked to a specific patient ID at
any time. It is thereby possible to link several sessions to the same patient ID.

Accessing Press ID in the top right corner of the view screens to enter the Patient DMS.
Patient DMS

Touch keys Touch key Function

Scroll between the patient IDs/session numbers in the list.
and
Adds a check mark to the highlighted patient ID/session no.
NOTICE: Only patient IDs/session numbers with a check
mark can be viewed, deleted, printed and exported.

Continued on next page

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Patient DMS, Continued

Touch keys Touch key Function
(continued)
Shows detailed information about the highlighted patient
ID/session number.

Change ID Enables changing the highlighted patient ID/session number

with the on-screen alphanumeric keyboard (see next page).
Maximum 64 characters.
NOTICE: When changing a patient ID/session number,
make sure to change it to something unique for each patient.
If the same ID is used for two patients, the DMS will not be
able to tell them apart.
Delete Deletes the patient IDs/session numbers with a check mark.
NOTICES:
• A dialog warns users that the action cannot be undone.
• The session in progress cannot be deleted.
Delete all Deletes all patient IDs/session numbers in the list.
NOTICES:
• A dialog warns users that the action cannot be undone.
• The session in progress cannot be deleted.
Print Prints a report (one or more report types) for the patient
IDs/session numbers with a check mark.
Export Exports the patient information and measuring data for the
patient IDs/session numbers with a check mark to an
external PC or a memory stick (see the sections Data
export: serial and Data export: USB later in this chapter).
NOTICE: The Export touch key is only active if "Data
export" has been selected in Technical settings.
OK Loads sessions with a check mark into the Trend table and
Trend curve views.
NOTICES:
• Only sessions with the same patient ID can be loaded
into the same view.
• If changes are made to the sessions that have been
loaded into a view, all the sessions will have to be loaded
into the view again.
Cancel Returns to the view screen.

Continued on next page

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Patient DMS, Continued

On-screen The following screen shows the basic keyboard layout:

alphanumeric
keyboard

Touch Key Function

Escape. To return to the Patient DMS screen without making
changes.
To switch between general and language-specific character
sets.
Placed in the upper right corner of the screen.
NOTICE: Not applicable in English.
Backspace. To delete one character at a time from right to
left.
Shift. To shift between different keyboards in the same
character set.
To scroll left/right in the text edit field.
or
Space. To add a space.

Enter. To accept the changes made in the text edit field and
return to the Patient DMS screen.

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Results in Normal view

Example of
Normal view
screen during
monitoring

NOTICES:
• The SpO2 plethysmograph displays data at a speed of 25 mm/s in Normal view.
• The visual indication of the plethysmograph curve is not proportional to the
pulse volume.
• The pCO2, pO2, SpO2 and Pulse parameter values are updated every 2 seconds.
• SpO2 and pulse are available on the TCM40 monitor only.
• On the TCM4 monitor, the lower part of the curve display will either show the
power curve or be empty, and the Pulse/SpO2 display will always be empty.

Curve display In Normal view, it is possible to change the curve ranges setup and the time span
setup during measurement by pressing the respective areas in the curve display.

Curve
Time span setup
ranges
setup

pCO2/pO2 In Normal view, it is possible to change the parameter setup during measurement
display by pressing the respective areas in the pCO2/pO2 display.

pCO2 parameter setup

Common to pCO2 and pO2

pO2 parameter setup

Continued on next page

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Results in Normal view, continued

pCO2/pO2 The pCO2/pO2 display also contains the following information:

display
(continued) Part Information
Corr. Metabolic or Severinghaus corrections are enabled.
Power Current power delivered to the sensor.
Temp. Current sensor temperature.
NOTICE: If the sensor temperature is flashing, the sensor
temperature differs from the set sensor temperature with
±0.6 °C.
SmartHeat SmartHeat has been enabled in the setup.
In vivo calibration Current pCO2/pO2 values are in vivo calibrated.
active

Pulse/SpO2 In Normal view it is possible to change the Pulse/SpO2 setup during measurement
display by pressing the Pulse/SpO2 display.

The Pulse/SpO2 display contains the following information:

Part Information
Pulse Pulse rate in beats per minute (bpm).
SpO2 Saturation level of oxygenated hemoglobin in %.
HI OFF SpO2 alarm high limit is disabled.

Markings in The following markings can be seen in Normal view:

Normal view
Marking Information
Blood gas values have been entered.
* An in vivo calibration has been performed.
1-99 An event mark number has been added.

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Results in Trend table view

Viewing results Step Action

in Trend table
view 1. Press Setup → View → Trend table → OK.
The following is an example of a trend table on a TCM40 monitor:

NOTICE: SpO2 and pulse are available on the TCM40 monitor only.
2. Press or to move up or down one line in the list of results, or
press to see the most recent results.
3. To print the results, press Print. See also How to print later in this
chapter.

Markings in The following markings can be seen in the Trend table:

Trend table
view Marking Indication
Blood gas values have been entered.
* An in vivo calibration has been performed.
- No value is available.
1-99 An event mark number has been added.

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Results in Trend curve view

Viewing results Step Action

in trend curve
view
1. Press Setup → View → Trend curve → OK.
The following is an example of a trend curve on a TCM40 monitor:

2. Press or to see more results to the left or the right.

3. Press Cursor to add a cursor to the screen. This will also change the
function of the Left and Right arrow keys: they now move the cursor
instead of time. If the cursor is moved all the way to one side, the time
axis moves, which makes it possible to go back and forth in time.

Cursor

The cursor values (pCO2, pO2, Power, SpO2, Pulse, Time and Date) are
shown in the lower right part of the screen, whereas current values are
shown in the upper right part of the screen.
Press Cursor again to remove the cursor from the screen.

Continued on next page

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Results in Trend curve view, Continued

Viewing results Step Action

in trend curve
view (continued) 4. To change the high or low values of the parameter ranges, press .
5. To print the results, press Print. See also How to print later in this
chapter.

Markings in The following markings can be seen in the Trend curve view:
Trend curve
view Marking Indication
Blood gas values have been entered.
* An in vivo calibration has been performed.
- No value is available.
1-99 An event mark number has been added.

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Analog output

Introduction The monitor is equipped with an output for direct connection to an external chart
recorder or polysomnograph.

Setting up Follow the steps below to connect the TCM4/40 monitor to an external chart
analog output recorder or polysomnograph:

Step Action
1. Connect the TCM4xx ETX Analog Adapter (code no. 636-650) to the
analog port.
NOTICE: Do not use other adapters than 636-650.
2. Connect the wires as follows:

Analog Wire Range

output color
Ground Blue N/A
Alarm Pink Activated: 1000 mV, ±10 mV
Not activated: 0 mV, ±10 mV
Heat Brown 1 mV/mW @ 10-1000 mW, ±10 mV (±10 mW)
< 10 mW ≈ 0 mV
Temp Green 20 mV/°C @ 10-50 °C, ±10 mV (±0.50 °C)
tcpCO2 Grey 10 mV/mmHg @ 0-100 mmHg, ±10 mV (±1 mmHg)
5 mV/mmHg @ 0-200 mmHg, ±10 mV (±2 mmHg)
tcpO2 Yellow 5 mV/mmHg @ 0-200 mmHg, ±10 mV (±2 mmHg)
1 mV/mmHg @ 0-800 mmHg, ±10 mV (±10 mmHg)
SpO2 White 10 mV/% SpO2 @ 0-100 % (±1 % SpO2)
Pulse Red 4 mV/bpm @ 20-250 bpm ±10 mV (≈ ±3 bpm)

3. On the monitor, press Setup → Technical. Enter the password and

press Enter and Tech. settings.
4. Use the Down arrow to select the pCO2 analog range and choose the
0-100 or 0-200 range.
5. Use the Down arrow to select the pO2 analog range and choose the
0-200 or 0-800 range.
6. Press OK to accept the changes and return to the main screen.
NOTICE: To test the analog output, calibrate the monitor. When the
calibration is complete, the analog output will correspond to the
tcpCO2 and tcpO2 readouts on the display.

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Continuous data output: standard

Introduction The monitor is equipped with a continuous data output for direct connection to an
external PC.

Connecting to Step Action

external PC
1. Connect the TCM4xx ETX Serial Adapter (code no. 636-649) to the
serial port on the monitor and to the PC.
The RS232 output from the monitor is transmitted continuously every 2
seconds in ASCII code in the following format:
[Timestamp]; [O2]; [CO2]; [Heater power]; [Temperature]; [SpO2]; [Pulse]
2. On the monitor, press Setup → Technical, enter the password and press
Enter and Tech. settings.
3. Use the Up and Down arrows to select "Continuous data output" and
choose the option "Standard".
4. Press OK to accept the changes and return to the main screen.
5. On the PC, select Start → Programs → Accessories → Communications
→ HyperTerminal and open the EXE file.
6. Type in a name for the connection, e.g. TcData, and then click OK.
7.

Connect using COM1 and click OK.

Continued on next page

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Continuous data output: standard, Continued

Connecting to Step Action

external PC
8. Select the following port settings and click OK.
(continued)

9. Collect the data in HyperTerminal by selecting Transfer → Capture text.

Then name the file, e.g. CAPTURE.txt, and click Start.
10. Stop the collection of data to the file in HyperTerminal by selecting
Transfer → Capture text → Stop.
The following shows a screen from HyperTerminal:

NOTICES:
• Data is easily imported into other programs, e.g. Microsoft Excel (see
the procedure under Data export: serial).
• It is possible to have analog and serial output at the same time. The
analog wires are short-circuit proofed.

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Continuous data output: VueLink

Introduction With a VueLink interface module type B, parameter values and attached alarm
limit values can be exported from a TCM monitor to a Philips Patient Monitoring
System (PPMS). The presentation of the data corresponds to Normal view.
NOTICE: Only the parameter values are displayed on the PPMS. The alarm limit
values can only be used by a data management system connected to the PPMS.

Required items • TCM4/40 monitors (software version 2.10 or newer)

• PPMS monitor (connected to one or more module racks)
• VueLink interface module type B (M1032A #A05)
• Connecting cable (Philips code no. M1032-61654) and TCM4xx ETX VueLink
Adapter (Radiometer code no. 636-651) for connecting the VueLink interface
module to the TCM monitor
NOTICE: In the following, the term PPMS includes the VueLink interface
module.

Possible PPMS The following patient monitors are supported:

monitors
• CMS (software version C or newer)
• IntelliVue MP40/50/60/70/90 (all software versions)
• Agilent V24/V26 (all software versions)
NOTICE: Older HP systems are often called CMS instead of PPMS.

Connecting to
PPMS monitor

TCM VueLink VueLink PPMS Module

monitor cables interface module monitor rack

Step Action
1. Insert a VueLink interface module in the PPMS monitor module rack.
2. Connect the VueLink interface module to the TCM monitor with the
connecting cable and the VueLink interface cable.
3. Turn on both monitors.
4. On the TCM monitor, press Setup → Technical (enter password) →
Tech. settings, set "Continuous data output" to "VueLink" and press
Apply or OK.
NOTICE: Changing settings for Unit will cause a temporary
disconnection of communication of up to 60 seconds. The connection
will be reestablished automatically.
Continued on next page

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Continuous data output: VueLink, Continued

Verification of Step Action

connection
1. On the VueLink interface module, press the VueLink key.
between TCM
and PPMS The "VueLink-B 1" tab appears on the PPMS monitor screen.
monitors
NOTICES:
• If the tab name is "AUXILIARY PLUS 1", connection to the
module has already been established.
• It is possible to insert several VueLink interface modules in the
PPMS monitor, and they will then be called "VueLink-B 2",
"VueLink-B 3", etc.
2. Wait for the text “... Connect device or switch to new device“ to
disappear.
NOTICE: If the text has not disappeared after 30 seconds, check the
cable connection. If the cable connection is okay, see chapter 7:
Troubleshooting for further operator actions.
3. Select the Setup VueLink softkey.
The "AUXILIARY PLUS 1" tab containing the parameter values from
the TCM monitor appears.

Example of task The task window "AUXILIARY PLUS 1" is displayed automatically when
window on connection between the TCM and the PPMS monitors has been established.
PPMS monitor
Device type

Device name

Parameter Alarm status

indication
Asterisk
Unit

Time

Only one of these two functions is accessible at a time.

Continued on next page

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Continuous data output: VueLink, Continued

Example of task NOTICES:

window on
• Transmission of data from the TCM monitor to the PPMS monitor may be
PPMS monitor
delayed with up to four seconds.
(continued)
• Printout of data from the TCM monitor may cut off the connection between the
TCM and the PPMS monitors while printing. The connection will be re-
established automatically.
• For examples of other PPMS monitors, please refer to the user instructions for
the relevant PPMS monitor.

The task window contains the following information:

Part Shows
Device type The type of connected module, e.g. AUXILIARY PLUS 1
(for the VueLink-B 1 module), AUXILIARY PLUS 2 (for
the VueLink-B 2 module), etc.
Device name The name of the connected TCM monitor, e.g. TCM4.
Alarm status Whether alarms on the TCM monitor have been activated.
indication
Parameter The parameters exported from the TCM monitor.
Asterisk That data for the following parameter is accessible on the
main screen and in external databases.
Unit The parameter units.
NOTICE: Units are only shown in the task window.
Time At which time the PPMS monitor started receiving data
from the TCM monitor.

Main screen on The main screen is displayed by pressing the Main Screen key on the PPMS
PPMS monitor monitor.
The parameters are displayed at the bottom right-hand corner of the PPMS monitor
screen:
Parameter on PPMS Color on PPMS Unit on PPMS and
(TCM monitor) (TCM monitor) TCM monitors
tcpCO2 (tcpCO2) Green (Blue) mmHg/kPa
tcpO2 (tcpO2) Green (Red) mmHg/kPa
SpO2 (SpO2) Green (Magenta) %
PULSE (Pulse) Green (Brown) bmp

NOTICE: It is not possible to change the colors on the PPMS monitor.

Continued on next page

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Continuous data output: VueLink, Continued

Configuration Some features, keys or softkeys may vary from one monitor system to another, but
of PPMS the principles are basically the same. If you encounter differences between your
monitor system and what we describe in this manual, please see the technical
documentation for the particular PPMS monitor.
The following configuration procedure is based on an Agilent V24C monitor.
Follow these steps to define how you want data presented on your PPMS monitor:
Step Action
1. Select the following softkeys: Module Setup → TCM (should have
appeared when the TCM monitor was connected) → Select Data.
2. Mark the module number (Num) you wish to change with the
up/down arrow keys.
3. Select the Select Signal softkey.
4. Select the Select Signal softkey again or use the left/right arrow keys
to turn the signal ON (by selecting a parameter) or OFF.
5. Select the Next Channel softkey.
6. Repeat steps 2-5 for other modules you wish to change.
7. Press the Main Screen key to finish and to display the selected
signals.

Alarms VueLink defines two types of alarms: red and yellow; but a TCM monitor only
gives yellow alarms.
A yellow alarm indicates a situation where a response of the medical staff is
necessary, but which is of less critical importance than a red alarm.
An alarm is displayed as a text on a yellow background at the top center of the
PPMS monitor screen, e.g. "TC ALARM", which means that an alarm limit has
been exceeded. Details about the specific alarm condition can be seen on the TCM
monitor.

Alerts Alerts are caused by errors related to the TCM monitor or its accessories.
An alert is displayed as a text on a green background at the top left-hand corner of
the PPMS monitor screen.

The following alerts may be displayed on the PPMS monitor screen:

Alert Interpretation
SEE TC MONITOR Details about the specific alert condition can be seen on
the TCM monitor.
TC BAT LOW Necessary to connect to mains.

Continued on next page

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Continuous data output: VueLink, Continued

Alerts Depending on the alert, parameter values may be displayed in the following ways:
(continued)
Parameter reading Interpretation
? (parameter value) Data may be wrong
-?- Provided data is wrong
(Blank) No data can be provided

NOTICE: Alarm/alert delays between the PPMS and TCM monitors are less than
two seconds.

Troubleshooting Symptom Cause Recommended action(s)

It is not possible Error related to • Check that both monitors are ON
to establish physical
contact between connection • Check the cable connection
the TCM and • If error remains, contact authorized
PPMS monitors service personnel
Incorrect • Check that the TCM monitor is set up
installation of for VueLink transmission
TCM monitor
• If error remains, contact authorized
service personnel
Incorrect • Reset the PPMS to factory defaults, or
installation of
PPMS monitor • Select Module Setup and set
"AUXILIARY PLUS 1" or "VueLink-
B" to "ON"
• If error remains, contact authorized
service personnel

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Continuous data output: MonLink

Introduction Enables TCM transmission of real-time data to external equipment. Any

interaction is initiated by host request that includes:

Request Reply
Status System/parameter status
Measuring values Measuring values and system/parameter status
Parameter ranges Analog ranges, selected alarm ranges and parameter alarm
status

Available
measured Parameter
TCM configuration
parameters pCO2 pO2 SpO2 PR Power
TCM4 monitor x x x
TCM40 monitor x x x x x

Detailed alarm and alert notifications are not communicated but have to be
revealed on the TCM monitor display.
All data values are updated every 2 seconds. How status and measured values are
presented is decided by and is under the responsibility of the vendor of the external
equipment.
NOTICE: For information on alarm delay and source/identification on external
equipment, please refer to the user instructions for the relevant external equipment.

Detailed For the detailed communication protocol, please see the document TCM
communication Communication Protocol Specifications (code no. 994-038) from Radiometer.
protocol

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Data export: serial

Introduction With the data export option, a dump of the trend data can be exported to an
external PC and presented in spreadsheet format.

Exporting data In this example, HyperTerminal version 690170 with Excel version 97 SR-2 is
to PC used.
Step Action
1. Connect the TCM4xx ETX Serial Adapter (code no. 636-649) to the
serial port on the TCM monitor and to the PC.
2. On the PC, select Start → Programs → Accessories →
Communications → HyperTerminal and open the EXE file.
3. Type in a name for the connection, e.g. TcData, and click OK.
4.

Connect using COM1 and click OK.

5. Select the following port settings and click OK.

Continued on next page

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Data export: serial, Continued

Exporting data Step Action

to PC
(continued)
6. Collect the data in HyperTerminal by selecting Transfer → Capture
text.
Then name the file, e.g. CAPTURE.txt, and click Start.
7. On the TCM monitor, press Setup → Technical, enter password and
press Enter and Tech. settings.
8. Set "Continuous data output" to "OFF", "Data export" to "Serial" and
"Data export interval" to 2, 10, 30 or 60 seconds. Then press OK.
The data is exported to HyperTerminal and can be seen on the PC.
9. On the PC, stop the collection of data to the file in HyperTerminal by
selecting Transfer → Capture text → Stop.
The following shows an extract of a screen from HyperTerminal:

Importing data Step Action

files into
Microsoft Excel
1. Open Excel and select Data → Get External Data → Import Text File.
2. Select the file CAPTURE.txt and click Import.
3. Select the following settings and click Next.

Continued on next page

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Data export: serial, Continued

Importing data
Step Action
files into
Microsoft Excel 4. Select the following settings and click Finish.
(continued)

5. Select the following settings and click OK.

6. Data is imported to Excel.

The following shows an extract of a screen from Excel:

7. Save (Log Excel worksheet).

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TCM4/40 operator's manual 6. Patient monitoring

Data export: USB

Introduction With this option, patient information and a dump of the trend data can be exported
to a memory stick through one of the USB ports.

Exporting data Step Action

to a memory
1. Connect a memory stick to one of the USB ports on the TCM monitor.
stick
2. Press Setup → Technical (enter password and press Enter) → Tech.
Settings.
3. Set "Data export" to "USB" and "Data export interval" to 2, 10, 30 or
60 seconds. Then press OK.
4. Press ID to access Patient DMS.
5. Select the patient ID(s)/session(s) to export and press Export. The
selected data will be exported to the USB port.
NOTICES:
• If a memory stick is not connected to the monitor, a dialog box will
be displayed, asking the user to insert a USB storage device. The
user can either cancel the data export by pressing Cancel or insert a
memory stick and press OK to initiate the data export.
• While data is being exported, a status dialog will be displayed. It
will not be possible to operate the monitor until the export of data
has been completed. Removing the memory stick before the data
export has been completed will result in incomplete data export.

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6. Patient monitoring TCM4/40 operator's manual

Alarms

Purpose The alarm system informs the user about physiological and technical errors, or it
gives text messages about recommended actions.
NOTICE: Every time the monitor is turned on, it performs a test of the alarm
system to check that the sound is working.

Definitions The alarm system contains three different "alarms":

• Alarms = physiological alarms: one or more of the parameter values have
exceeded or are equal to the high or low alarm limits
• Alerts = technical alarms: inform the user if e.g. an error has been detected
during calibration
• Messages = pure text, e.g. "Ready"

Alarms Alarms are enabled/disabled in Parameter setup.

NOTICE: If the symbol is displayed on the screen, all visual and acoustic
alarm indications are disabled. Alerts are not affected.
It is possible to choose between two modes (see Technical settings in chapter 3:
Menu structure and setup programs):

• Latching: The monitor remains in alarm status even though the alarm
condition ceases to exist. So even if all parameter values
are back within the alarm limits, the user must reset the
alarm.
• Non-latching: The monitor resets itself as soon as the alarm condition
ceases to exist.

An alarm is made up of visual indications (the parameter value and an alarm text
will be flashing) and an acoustic indication (a discontinuous tone).

Alarm limit
symbols

Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

Alarms, Continued

Alerts An alert cannot be turned off but disappears automatically when the alert condition
ceases to exist.
An alert is made up of visual indications ("Alert" displayed in the headline field
and a text explaining the problem in the curve view field of the affected parameter)
and an acoustic indication (a discontinuous tone).

Alarm silence It is possible to silence an alarm or an alert for two minutes by pressing the Alarm
silence touch key. A progress bar will then be displayed on the Alarm silence
touch key, showing the progress of the alarm silence period. However, if an
alarm/alert is activated for another parameter during the silence period, this will
discontinue the silence period and activate the alarm/alert sounds.
NOTICE: When affixing the sensor to the patient, i.e. when the monitor goes from
Ready to Measuring mode, the alarm silence period starts automatically and lasts
for 10 minutes.

Alarm reset When the alarm silence period times out, the alarm system is reset.
The alarm system can also be reset by pressing the Alarm silence touch key twice
(or once, if the alarm silence is already activated).
If the alarm/alert condition is still present when the alarm system is reset, the
visual indications will remain for both types of alarms, whereas the acoustic
indication will be reactivated for an alarm condition only.

Alarm tone An alarm tone consists of bursts of 10 short pulses. Between two bursts there is a
3-second pause. The alarm tone continues until the alarm condition ceases to exist
or Alarm silence is activated.

Continued on next page

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6. Patient monitoring TCM4/40 operator's manual

Alarms, Continued

Alert tone An alert tone consists of two pulses followed by a 5-second pause. The alert tone
continues until the alert condition ceases to exist or Alarm silence is activated.

End-of- An End-of-calibration tone consists of two pulses.

calibration
tone

TCM40 With traditional alarm management, upper and lower alarm limits are set for
SatSeconds monitoring oxygen saturation. During monitoring, as soon as an alarm limit is
violated by as little as one percentage point, an audible alarm immediately sounds.
When the SpO2 level fluctuates near an alarm limit, the alarm sounds each time the
limit is violated. Such frequent alarms can be distracting.
Therefore, the TCM40 SpO2 module utilizes SatSeconds alarm management. With
the SatSeconds technique, upper and lower alarm limits are set in the same way as
traditional alarm management. However, the clinician also sets a SatSeconds limit
that allows monitoring of SpO2 below the selected lower alarm limit and above the
selected upper alarm limit for a period of time before an audible alarm sounds.
The SatSeconds limit controls the time that the SpO2 level may violate the alarm
limits before an audible alarm sounds. SatSeconds is enabled/disabled in SpO2
parameter setup.
The method of calculation is as follows:
The number of percentage points that the SpO2 falls outside the alarm limit is
multiplied by the number of seconds that the SpO2 level remains outside that limit.
This can be stated as an equation:
points × seconds = SatSeconds
where:
• points = SpO2 percentage points outside of the limit
• seconds = number of seconds that SpO2 remains at that point outside of the limit
The alarm response time, assuming a SatSeconds limit set at 60 and a lower alarm
limit set at 90, is described and illustrated below.
In this example, the SpO2 level drops to 88 (2 points) and remains there for a
period of 2 seconds (2 points × 2 seconds = 4). The SpO2 then drops to 86 for 3
seconds and then to 84 for 8 seconds. The resulting SatSeconds are:
SpO2 Seconds SatSeconds
2× 2= 4
4× 3= 12
6× 8= 48
Total SatSeconds = 64
Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

Alarms, Continued

TCM40 After approximately 13 seconds, the SatSeconds alarm will sound, because 60
SatSeconds SatSeconds will have been exceeded. See arrow (↑) in the figure below.
(continued)

60-second
SatSeconds
alarm point

Seconds

Saturation levels may fluctuate rather than remain steady for a period of several
seconds. Often, SpO2 levels may fluctuate above and below the alarm limit, re-
entering the non-alarm range several times.
During such fluctuation, the TCM40 monitor integrates the number of SpO2 points,
both positive and negative, until either the SatSeconds limit (SatSeconds setting) is
reached or the SpO2 level returns to within a normal range and remains there.

SatSeconds The SatSeconds "safety net" is for patients whose saturation levels frequently
"safety net" exceed the high or low alarm limit but do not stay outside the limit long enough for
the SatSeconds setting to be reached. When three or more limit violations occur in
60 seconds, an alarm will sound even if the SatSeconds setting has not been
reached.

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6. Patient monitoring TCM4/40 operator's manual

How to print

Connecting a Step Action

printer
1. Shut down the monitor by following the procedure described in
chapter 4: Installation and maintenance.
2. Connect an HP printer with PCL3 protocol to one of the USB ports on
the rear of the monitor.
3. Switch on the monitor.

Printing reports Step Action

1. If required, go into Printer setup to change the printer settings (see
chapter 3: Menu structure and setup programs).
2. Press Print and set the printer start and stop times.
NOTICES:
• The monitor must be connected to a printer with PCL3 protocol.
• The memory function holds a total of 48 hours of monitoring data.
• The printed report will be performed in accordance with the printer
settings selected in the printer setup.
• The time span selected in the printer setup will influence the start
time of the Printer start/stop time screen, as the interval between the
printer start and stop times corresponds to the time span; i.e. if the
time span is set to 1 hour, the interval between the printer start and
stop times will also be 1 hour (See Printer setup in chapter 3).
• The scroll interval depends on the time span selected in the printer
setup. If the time span is set to less than 1 hour, the scroll interval will
correspond to the exact time span (e.g. 5, 15 or 30 min). If the time
span is set to 1 hour or more, the scroll interval will be 1 hour.
• The stop time is set to current time and then adjusted to match the
time of the latest data record. The stop time can therefore differ from
current time with up to 2 hours, depending on the time interval
selected in the printer setup.
3. Press OK to make a printout, or press Cancel to exit the dialog box
without making a printout.
NOTICES:
• The different kinds of event marks are only shown on the printout if
they are actually present.
• Even if both report types are selected in Printer setup, there will only
be one "Comments" page.

Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

How to print, Continued

Example of RADIOMETER TCM4 SERIES

table report
Transcutaneous measurement (tcpCO2/tcpO2/SpO2/Pulse)
Measuring unit: tcpCO2/tcpO2 mmHg Sensor temperature: 42.0 °C
Power mW Last calibration 01:27:07 02/03/2004
SpO2 % Last calibration value: pCO2 80 mmHg
Pulse bpm pO2 160 mmHg

Facility name:______________________________________________________________________________

Patient name/ID:____________________________________________________________________________

Blood gas event mark * In vivo calibration - No value available

Time/date Event tcpCO2 tcpO2 Power SpO2 Pulse

02:23:00 02/03/04 34 158 3 97 71
02:24:00 02/03/04 34 158 7 97 71
02:25:00 02/03/04 1 34 158 11 97 71
02:26:00 02/03/04 34 158 - 97 71
02:27:00 02/03/04 - 158 16 96 70
02:28:00 02/03/04 2 34 158 19 96 70
02:29:00 02/03/04 34 158 23 97 72
02:29:13 02/03/04 - - - 97 72
02:30:00 02/03/04 34 158 26 97 72
02:31:00 02/03/04 3 34 158 30 97 72
02:32:00 02/03/04 34 158 31 97 72
02:33:00 02/03/04 34 158 33 97 72
02:34:00 02/03/04 34 158 37 97 72
02:35:00 02/03/04 34 158 - 97 72
02:36:00 02/03/04 - 158 40 97 72
02:37:00 02/03/04 34 158 43 97 72
02:38:00 02/03/04 34 158 46 97 72
02:39:00 02/03/04 34 158 51 97 72
02:40:00 02/03/04 34 158 52 97 72
02:41:00 02/03/04 34 158 52 97 72

Printed: 02:53:07 02/03/2004 Page 1

Continued on next page

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6. Patient monitoring TCM4/40 operator's manual

How to print, Continued

Example of RADIOMETER TCM4 SERIES

table report
(continued)
Transcutaneous measurement (tcpCO2/tcpO2/SpO2/Pulse)

Facility name:_____________________________________________________________________________

Patient name/ID:___________________________________________________________________________

Comments:____________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

Physician’s signature:_______________________________________ Date:__________________________

Printed: 02:53:07 02/03/2004 Page 2

Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

How to print, Continued

Example of RADIOMETER TCM4 SERIES

curve report
Transcutaneous measurement (tcpCO2/tcpO2/SpO2/Pulse)
Measuring unit: tcpCO2/tcpO2 mmHg Sensor temperature: 42.0 °C
Power mW Last calibration 01:27:07 02/03/2004
SpO2 % Last calibration value: pCO2 80 mmHg
Pulse bpm pO2 160 mmHg

Facility name:_____________________________________________________________________________

Patient name/ID:___________________________________________________________________________

Blood gas event mark * In vivo calibration

800 m m Hg tcpO 2

400

* ** ** * * * * * * *

0
02:27 02: 31 02: 35 02:39
02: 23: 00 02/ 03/ 2004 02:41:00 02 /03/2004
02:41:00 02/03/2004

200 m m Hg tcpCO2

100

0
02:27 02:31 02:35 02:39
02:23:00 02/03/2004
02:41:00 02/03/200 4
02:41:00 02/03/2004

Printed: 02:53:07 02/03/2004 Page 1

Continued on next page

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6. Patient monitoring TCM4/40 operator's manual

How to print, Continued

Example of RADIOMETER TCM4 SERIES

curve report
(continued) Transcutaneous measurement (tcpCO2/tcpO2/SpO2/Pulse)

Facility name:_____________________________________________________________________________

Patient name/ID:___________________________________________________________________________

700 mW Power
Power

300

0
02:27 02:31 02:35 02:39
02: 23: 00 02/ 03/ 2004 02:41:00 02/03/2004
02:41:00 02/03/2004

10 0 %
SpO
SpO22

50

0
02 :2 7 02 : 31 02: 35 02 :3 9
02 : 23: 00 02/ 03 / 2004 02 :4 1:00 0 2/03 /2 00 4
02:41:00 02/03/2004
Pulse
250 bp m Pulse

125

02:2 3:00 02/ 03/ 2004 02: 27 0 2:31 02:35 02:39

02:4 1:00 02/03/2004
02:41:00 02/03/2004

Printed: 02:53:07 02/03/2004 Page 2

Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

How to print, Continued

Example of RADIOMETER TCM4 SERIES

curve report
(continued)
Transcutaneous measurement (tcpCO2/tcpO2/SpO2/Pulse)

Facility name:_____________________________________________________________________________

Patient name/ID:___________________________________________________________________________

Comments:____________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

Physician’s signature:_______________________________________ Date:__________________________

Printed: 02:53:07 02/03/2004 Page 3

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6. Patient monitoring TCM4/40 operator's manual

Blood gas comparison

Introduction It is possible to key in the pCO2 and pO2 blood gas values of a patient to compare
these with transcutaneous measurements from the same patient. The blood gas
values are displayed as blood drops in all views as well as on all printed reports.

Keying in Step Action

blood gas value
1. Make sure that the sensor is placed on the patient and that the tcpCO2
and tcpO2 values are stable.
2. Before drawing the blood sample, press Setup → Parameter → Blood
gas → Sample time. The monitor will store the tc values at that time
and the pCO2 and pO2 input fields and the numeric keypad are now
accessible.
3. Draw the blood sample and perform a blood gas analysis.
4. When the blood gas results are ready, enter the Blood gas setup, press
the pCO2 input field and key in the value with the numeric keypad.
NOTICES:
• The l-- key deletes one character at a time from the right.
• If the pCO2 or pO2 input field is dimmed, the parameter is not
available, either because of the sensor type or because pO2 is
disabled in Technical setup.
5. Press the pO2 input field and key in the value with the numeric
keypad, and then press OK.
The blood gas values will be displayed as blood drops in Normal view
as in the following example:

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TCM4/40 operator's manual 6. Patient monitoring

In vivo calibration

Introduction It is possible to perform in vivo calibrations, i.e. alterations in the transcutaneous

readings, using the results from an arterial blood gas analysis. In vivo calibrations
can either be performed on pCO2, pO2 or both parameters.
When the blood gas values have been entered on the TCM4/40 monitor, the new
calibration lines are calculated.
The following formulas are used:
tcpCO2(corr) = tcpCO2 + [pCO2(a) – tcpCO2(t)]
tcpO2(corr) = tcpO2 × [pO2(a) / tcpO2(t)]
where
• tcpCO2 is either the measured CO2 value or the measured CO2 value with
correction (if corrections are selected in Technical settings)
• pCO2(a) and pO2(a) are the measured arterial values
• tcpCO2(t) and tcpO2(t) are the transcutaneous values measured at time t, which is
the approximate time when the arterial sample was taken and the Sample time
touch key was pressed.
On the pCO2 part, the corrected (CORR) value line will have the correct (45°)
slope. The in vivo calibration, therefore, gives an offset for all values – i.e. it moves
the line – just as changing the metabolic factor in Technical settings would do.

On the pO2 part of the sensor, the in vivo calibration changes the sensitivity (the
slope) of the pO2 signal, just as with normal calibrations.

Continued on next page

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6. Patient monitoring TCM4/40 operator's manual

In vivo calibration, Continued

Introduction NOTICES:
(continued)
• In vivo calibration should not be performed on hemodynamically unstable
patients, because the arterial blood gas value and the tc value may fluctuate
considerably.
• In vivo calibration of a tc value will bring the displayed value closer to the
arterial sample reading. But the correlation between the tc and the arterial values
will remain unchanged.
• In vivo calibration does not make the TCM monitor read arterial values. Nor
does it eliminate the blood flow dependence on the tc value or any of the other
determinants. It gives the same information as the original tc value – only on
another level (see the graph below).
tcpO2

tcpO2 pO2(a) tcpO2

Performing an Step Action

in vivo
1. Make sure that access to the In vivo calibration touch key has been
calibration
enabled in Technical settings, that the sensor is placed on the patient
and that the tc values are stable.
2. Before drawing the blood sample, press Setup → Parameter → Blood
gas → Sample time. The monitor will register the blood sampling time
and the pCO2 and pO2 input fields and the numeric keypad are now
accessible.
3. Draw the blood sample and perform a blood gas analysis.
4. When the blood gas result is ready, enter the Blood gas setup, press the
pCO2 input field and key in the value with the numeric keypad.
5. Then press the pO2 input field and key in the pO2 value.
6. Press In vivo calibration and OK.

Continued on next page

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TCM4/40 operator's manual 6. Patient monitoring

In vivo calibration, Continued

Performing an
Step Action
in vivo
calibration The curves will now be marked with *, indicating that the measured
(continued) values are in vivo calibrated and no longer show the original
transcutaneous values.

NOTICES:
• The in vivo calibration procedure can be repeated during the
monitoring period if you wish to alter the values again according to
the results of new blood samples.
• To return to the original tc values, simply put the sensor back in the
calibration chamber.

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6. Patient monitoring TCM4/40 operator's manual

6-48
 7. Troubleshooting

The TCM4/40 systems ..................................................................................... 7-2

7. Troubleshooting TCM4/40 operator’s manual

The TCM4/40 systems

Introduction The monitor contains Radiometer-developed software that has been developed,
tested and released according to our certified Quality Assurance System in order to
minimize hazards arising from the software. Furthermore, the status of the system
is continuously monitored during operation. Should a problem or error occur, it is
automatically recorded and presented to the operator on the screen.
This chapter describes possible errors, their causes and the recommended operator
actions.
NOTICE: The monitor cover should be removed only by authorized service
personnel. There are no user-serviceable parts inside.

Error Symptom Cause Recommended action(s)

symptoms
Monitor not • Monitor is defective • Check the connections
operational • Battery is exhausted • Contact authorized
• Monitor is not connected service personnel
to mains
Measured values • Insufficient removal of • Remembrane the sensor
drift when sensor is old electrolyte during • Check sensor zero current
measuring on cal membraning procedure and sensitivity
gas (in vitro) • Air bubbles in electrolyte
• The sensor membrane has
not been changed
regularly
• Defective sensor mem-
brane (holes or scratches)
• Defective O-rings (one or
both O-rings are broken)
Measured values • Improper attachment of • Detach the sensor and
drift constantly the sensor reapply correctly
without any clinical • Improper attachment of • Detach the fixation ring
cause when sensor the fixation ring and reapply correctly
is mounted on
patient (in vivo) • An inappropriate • Check sensor zero current
measurement site has and sensitivity
been selected
• Inadequate vasodilation
• Hole in the membrane Remembrane the sensor
• Air under the membrane

Continued on next page

7-2
TCM4/40 operator’s manual 7. Troubleshooting

The TCM4/40 systems, Continued

Error Symptom Cause Recommended action(s)

symptoms
(continued) Measured values • Patient status unstable • Evaluate patient status
not stable or out of • Inadequate vasodilation • Remount the sensor
range 20 minutes
after application • Improper attachment of
the sensor
• Sensor exposed to high Remembrane the sensor
ambient light
• Hole in the membrane
• Air under the membrane
Measured values • Inaccurate result due to Recalibrate and reapply
change suddenly patient movements sensor to the skin, possibly
without any clinical selecting a new measuring
cause • Air leakage under site
fixation ring
• Self-adhesive ring does
not stick to the skin
• Hole in the membrane Remembrane the sensor
• Air under the membrane
Noise appears on Interference from nearby Increase the distance from
the tension readout equipment the interfering equipment

Monitor error Error message Cause Recommended action

message
Battery level low Battery level is low Connect the monitor to the
mains

tc error Error message Cause Recommended action(s)

messages – in
alphabetical Calibration error. Barometer value invalid • Start a new calibration
Barometer error when collected at start of
order
during calibration. calibration • If error remains, contact
authorized service
personnel
Calibration error. • Calibration chamber is • Check chamber sealing
Gas flow out of blocked
range. • Contact authorized
• Calibration unit is service personnel
defective
Calibration error. Less than 10 calibrations Change gas bottle
Gas level low. left

Continued on next page

7-3
7. Troubleshooting TCM4/40 operator’s manual

The TCM4/40 systems, Continued

tc error Error message Cause Recommended action(s)

messages – in
alphabetical Calibration error. There is a leak in the • Check that a gasket is
order Leak error in calibration chamber present and positioned
(continued) calibration chamber. correctly in the chamber
• Check that the sensor is
positioned correctly in
the chamber
Calibration error. No sensor detected in the Place a tcpCO2/tcpO2 sensor
No sensor calibration chamber at start in the chamber
connected to the of or during calibration
chamber.
Calibration error. The sensor has been • Start a new calibration
Sensor drift during rejected during the drift
calibration. check • If error remains, remem-
brane the sensor, and start
a new calibration.
• If error remains, the
sensor is defective.
Replace with a new one.
Calibration error. The sensor sensitivity is • If the sensor has just been
Sensor sensitivity outside the specifications remembraned, start a new
error during calibration
calibration.
• Otherwise remembrane
the sensor and start a new
calibration
• Sensor is defective.
Replace with a new one.
Calibration error. The selected sensor • Calibrate the sensor
Sensor temperature temperature value cannot be
error during reached • If error remains, the
calibration. sensor is defective.
This may be due to Replace with a new one.
an error in the
sensor module.
Calibration required • The last calibration has Perform a calibration
been aborted
• 12 hours have passed
since the last successful
calibration
• SmartCal has timed out

Continued on next page

7-4
TCM4/40 operator’s manual 7. Troubleshooting

The TCM4/40 systems, Continued

tc error Error message Cause Recommended action(s)

messages – in Communication For unknown reasons, the • If error remains, try with
alphabetical error. communication between the another module
order Sensor module monitor and the tc module
(continued) disconnected. has not been satisfactory • If error remains on the
Call service. new module, contact
authorized service
personnel
General error. The tc module or sensor is • Try with another module
Call service. not functioning or sensor
• If error remains, contact
authorized service
personnel
Heater failure • The measured sensor • Unplug the sensor from
power is outside the the sensor socket at the
measuring range rear of the module, and
then reconnect it.
Calibrate the sensor.
• If error remains, the
sensor is defective.
Replace with a new one.
The selected sensor Check if the patient or the
temperature cannot be surroundings are very cold
reached
Invalid sensor No tcpCO2/tcpO2 sensor Change the sensor
connected detected
No sensor • No sensor detected in the Connect a functional
connected calibration chamber tcpCO2/tcpO2 sensor
• The sensor in the
calibration chamber is not
functioning
pCO2 out of range • The measured pCO2 • Change the membrane
value is outside the • Change the sensor
measuring range
• The pCO2 sensor is low
on battery power

pO2 out of range The measured pO2 value is • Change the membrane
outside the measuring range
• Change the sensor
Site time end The site time counter has • Reposition the sensor on
reached zero the patient
• Recalibrate the sensor

Continued on next page

7-5
7. Troubleshooting TCM4/40 operator’s manual

The TCM4/40 systems, Continued

tc error Error message Cause Recommended action(s)

messages – in Temperature failure • Measured temperature is • Calibrate the sensor
alphabetical
outside the measuring
order • If error remains, the
range
(continued) sensor is defective.
• The two sensor Replace with a new one.
thermistors give different
temperatures
• The sensor temperature is
too high
Temperature indi- The selected sensor Wait until it is reached
cation is flashing temperature has not yet
(No text is shown) been reached

SpO2 error Error message Cause Recommended action(s)

messages – in
alphabetical Communication For unknown reasons, the • If error remains, try with
order error. communication between the another module
SpO2 module monitor and the SpO2
disconnected. module has not been • If error remains on the
Call service. satisfactory new module, contact
authorized service
personnel
General error. SpO2 module or sensor is • Try with another module
Call service. not functioning or sensor
• If error remains, contact
authorized service
personnel
No sensor • No SpO2 sensor Connect an SpO2 sensor to
connected connected to the monitor the monitor
• Invalid sensor connected
to the monitor

Dialog box A number of messages (system messages and alerts) appear in dialog boxes.
messages – in
System message Cause
alphabetical
order Battery level Less than 5 minutes running time on battery
critically low
Battery level is The user has made changes in the setup while the
critically low. Setup battery level was critically low
changes cannot be
saved.

Continued on next page

7-6
TCM4/40 operator’s manual 7. Troubleshooting

The TCM4/40 systems, Continued

Dialog box
messages – in System message Cause
alphabetical Battery not connected. No battery is connected to the monitor
order For data safety
(continued) reasons, a proper
battery must always
be connected.
Battery not connected. The user has made changes in the setup while the
Setup changes cannot battery was not connected
be saved.
Blood gas setup is The user has tried to enter the Blood gas setup while the
only available in monitor is not monitoring
measuring mode.
You cannot enter this
menu.
Data error. Shut RAM failure on the PC unit
down system
immediately.
Data export Export of data to the USB storage device has been
completed completed
Data export failed Export of data to the USB storage device has failed. E.g.
due to missing USB storage device.
Data from more than The user has tried to load sessions from different patient
one patient cannot be IDs into a view
selected into a view
Date and time cannot The user has tried to enter the Date/time setup during
be set during measurement
measurement
Exporting data. Data is being exported to the USB storage device
Please wait.
Incorrect password. The user has tried to enter the Technical setup with an
Try again. incorrect password
Incorrect time. Try The user has entered an incorrect time
again.
Insert USB storage Export to USB port was selected without a memory
device stick being connected to the USB port
Monitor temperature The temperature in the CPU is too high
too high. Please shut
down system
immediately.

Continued on next page

7-7
7. Troubleshooting TCM4/40 operator’s manual

The TCM4/40 systems, Continued

Dialog box System message Cause

messages – in
alphabetical No sessions selected. The user has tried to view session information (in
order Select one or more Patient DMS) without selecting a session
(continued) sessions.
One or more sessions The user has selected one or more sessions in Patient
will be deleted from DMS and pressed Delete or Delete all
the system. This
action cannot be
undone.
pO2/pCO2 not • The pO2 parameter is disabled in Technical setup, and
enabled. You cannot the user is trying to enter the pO2 parameter setup
enter this menu.
• A tcpO2 sensor is connected, and the user is trying to
enter the pCO2 parameter setup
Saving data. Please The monitor is saving data before shutting down
wait.
The monitor is The user has tried to delete the session in progress
measuring. Current
session cannot be
deleted.
The monitor is The user has tried to select one or more sessions – other
measuring. No other than the one in progress – into a view
sessions can be
loaded into the view.
The sensor must be The user has tried to change the sensor temperature
recalibrated if the during Ready or Measuring state
temperature is
changed. Do you
want to change the
temperature?

Pure text Text message Cause

messages – in
alphabetical Calibrating The sensor is being calibrated
order Ready The sensor has been calibrated and is ready for use

7-8
8. Specifications and ordering information

Specifications ................................................................................................... 8-2

Accessories....................................................................................................... 8-14
8. Specifications and ordering information TCM4/40 operator's manual

Specifications

TCM4/40 Item Description

monitor
specifications Measured parameters tcpCO2, tcpO2, SpO2, pulse rate and sensor heating power
Display update period SpO2 plethysmograph: 25 mm/sec
Numerical values: 2 sec
pCO2/pO2 graphs: 2 sec
Display range tcpCO2: 0-200 mmHg or 0.0-26.7 kPa
tcpO2: 0-800 mmHg or 0.0-99.9 kPa
SpO2: 0-100 %
Pulse rate: 0 and 20-300 beats per minute (bpm)
Measuring range tcpCO2: 5-100 mmHg or 0.7-13.3 kPa
tcpO2: 0-800 mmHg or 0.0-99.9 kPa
SpO2: 70-100 %
Pulse rate: 20-250 bpm
Sensor heating power 10-650 mW ± 3 % of reading (< 10 mW ~ 0 mW)
range
Temperature settings 37.0-45.0 °C in steps of 0.5 °C
in °C
Barometer Built-in: 375-825 mmHg or 50-110 kPa
Accuracy: ±5 mmHg or 0.67 kPa
Calibration Calibration gas (7.5 % CO2, 20.9 % O2, balance N2)
Ambient relative 20-80 %
humidity
Ambient temperature Monitor: 5-40 °C
tc sensors: 15-40 °C
NOTICES:
• The ambient temperature must always be at least 3 °C
lower than the set sensor temperature.
• If SmartCal is selected, the maximum ambient
temperature is 34 °C.
SpO2 sensors: 5-40 °C
Transport and storage The monitor and modules can be transported and stored at
conditions –20 to +60 °C and < 95 % RH.
Data storage Up to 48 hours of monitoring data in 2-second data
intervals

Continued on next page

8-2
TCM4/40 operator's manual 8. Specifications and ordering information

Specifications, Continued

TCM4/40 Item Description

monitor
specifications Computer Screen: 6½" color touch TFT, full VGA (640 × 480)
(continued) CPU: AMD ETX LX800, 500 MHz (Pentium Class)
Software platform: Windows CE 5.0
Interface connection Serial output EIA232, (RS232)
Printer output USB 2.0 (compliant with USB 1.1)
Analog output 0-1 V
Power supply 100-240 V 50-60 Hz
Battery Rechargeable Under normal conditions, the battery can
Pb battery operate for 1 hour before recharging is
needed
Dimensions of Height: 16 cm 6.3 in
monitor Width: 30.8 cm 12.1 in
Depth: 23 cm 8.7 in
Weight: 4 kg 8.8 lbs
Dimensions of tc Height: 10.7 cm 4.2 in
module Width: 14.5 cm 5.7 in
Depth: 14.8 cm 5.8 in
Weight: 0.6 kg 1.3 lbs
Dimensions of SpO2 Height: 3.5 cm 1.4 in
module Width: 14.5 cm 5.7 in
Depth: 14.8 cm 5.8 in
Weight: 0.21 kg 0.5 lb
Alarm sound At highest Alarm tone: 83 dBA
pressure alarm sound Alert tone: 73 dBA
level End-of-calibration tone: 64 dBA
At lowest Alarm tone: 65 dBA
alarm sound Alert tone: 58 dBA
level End-of-calibration tone: 51 dBA

Continued on next page

8-3
8. Specifications and ordering information TCM4/40 operator's manual

Specifications, Continued

EMC approvals The monitor is intended for use in the electromagnetic environment specified in the
and compliance tables below. The customer or user of the monitor should assure that it is used in
such an environment. The monitor complies with IEC 60601-1-2.
Guidance and manufacturer's declaration – electromagnetic emissions
Emissions test Compliance Electromagnetic environment
guidance
RF emissions Group 1 The monitor's RF emissions are very low
CISPR 11 and they are not likely to cause any
interference in nearby electronic
equipment.
RF emissions Class A The monitor is suitable for use in all
CISPR 11 establishments other than domestic and
those directly connected to the public
Harmonic emissions N/A low-voltage power supply network that
IEC 61000-3-2 supplies buildings used for domestic
Voltage fluctuations/ N/A purposes.
flicker emissions
IEC 61000-3-3

Guidance and manufacturer's declaration – electromagnetic immunity

Immunity IEC 60601 Compliance Electromagnetic environment
test test level level guidance
Electrostatic ±6 kV ±6 kV Floors should be wood, con-
discharge contact contact crete or ceramic tile. If floors
(ESD) are covered with synthetic
±8 kV air ±8 kV air
material, the relative humidity
IEC 61000-4-2
should be at least 30 %.
Electrical fast ±2 kV for ±2 kV for Mains power quality should be
transient/burst power supply power supply that of a typical commercial
lines lines and/or hospital environment
IEC 61000-4-4
±1 kV for ±1 kV for
input/output input/output
lines lines
Surge ±1 kV ±1 kV Mains power quality should be
differential differential that of a typical commercial
IEC 61000-4-5
mode mode and/or hospital environment
±2 kV ±2 kV
common common
mode mode

Continued on next page

8-4
TCM4/40 operator's manual 8. Specifications and ordering information

Specifications, Continued

EMC approvals Immunity IEC 60601 Compliance Electromagnetic environment

and compliance test test level level guidance
(continued)
Voltage dips, < 5 % UT N/A, as the None
short (> 95 % drop monitor has
interruptions, in UT) for 0.5 battery
and voltage cycle backup
variations on
40 % UT
power supply
(60 % drop
input lines
in UT) for 5
IEC 61000-4-11 cycles
70 % UT
(30 % drop
in UT) for 25
cycles
< 5 % UT
(> 95 % drop
in UT) for 5
seconds
Power 3 A/m 3 A/m None
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTICE: UT is the AC mains voltage prior to application of the test level.

Continued on next page

8-5
8. Specifications and ordering information TCM4/40 operator's manual

Specifications, Continued

EMC approvals Immunity IEC 60601 Compliance Electromagnetic environment

and compliance test test level level guidance
(continued) Portable and mobile RF communi-
cations equipment should be used
no closer to any part of the monitor,
including cables, than the recom-
mended separation distance calcu-
lated from the equation appropriate
for the frequency of the transmitter.
Recommended separation
distance
d = 1.2 P 150 kHz to 80 MHz
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz d = 1.2 P 80 MHz to 800 MHz

Radiated RF 3 V/m 3 V/m

d = 2.3 P 800 MHz to 2.5 GHz
80 MHz to
IEC 61000-4-3
2.5 GHz where P is the output power rating
of the transmitter in watts (W)
according to the transmitter manu-
facturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should
be less than the compliance level in
each frequency rangeb.
Interference may occur in the vicin-
ity of equipment marked with the
following symbol:

a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele-
phones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the monitor is used exceeds the applicable RF compliance
level above, the monitor should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the monitor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTICES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Continued on next page

8-6
TCM4/40 operator's manual 8. Specifications and ordering information

Specifications, Continued

EMC approvals Recommended separation distances between portable and mobile RF

and compliance communications equipment and the TCM monitor
(continued)
The monitor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the monitor can
help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
monitor as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
in meters
Rated output
power of 150 kHz to 80 MHz to 800 MHz to
transmitter 80 MHz 800 MHz 2.5 GHz
Watts
d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at an output power not listed above, the recommended separation
distance d in meters can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in the
corresponding column.
NOTICES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.

Other approvals Item Description

and compliance
Patient safety • The instrument complies with IEC 60601-1 and IEC
60601-2-23.
• The following test house has approved the instrument:
CSA in Canada according to CAN/CSA-C22.2 No. 601.1-
M90, 601.1S1-94, 601.1B-98, 601.2.23-02 and UL std.
No. 60601-1.

Continued on next page

8-7
8. Specifications and ordering information TCM4/40 operator's manual

Specifications, Continued

Other approvals Item Description

and compliance
(continued) Compliance The monitor complies with:
• IEC-60601-1, Medical Electrical Equipment – Part 1:
General requirements for safety
• IEC-60601-1-2, Medical Electrical Equipment – Part 1-2:
General requirements for safety. Collateral standard:
Electromagnetic compatibility - requirements and tests
• IEC-60601-1-4, General requirements for safety and
design of programmable electrical medical systems
• IEC-60601-2-23, Medical Electrical Equipment – Part 2-
23: Particular requirements for the safety, including
essential performance, of transcutaneous partial pressure
monitoring equipment
• IEC-60601-2-49, Medical Electrical Equipment – Part 2-
49: Particular requirements for the safety of multifunction
patient monitoring equipment.
• IEC-60601-3-1, Medical Electrical Equipment – Part 3-1:
Essential performance requirements for transcutane-ous
oxygen and carbon dioxide partial pressure monitoring
equipment
• ISO 9919, Medical Electrical Equipment. Particular
requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use
• IEC-60601-1-8, Medical Electrical Equipment – Part 1-8:
General requirements for safety. Collateral standard:
General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical
electrical systems
• Class II Special Controls Guidance Document: Cutaneous
Carbon Dioxide (tcpCO2) and Oxygen (tcpO2) Monitors;
Guidance for Industry and FDA (December 13, 2002)
• Draft Guidance for Industry and Staff: Pulse oximeters
premarket notifications submissions [510(k)s]
pCO2 Non-linearity and hysteresis:
The requirement to non-linearity and hysteresis (±5 mmHg)
is fulfilled for gas concentrations between 5 % and 10 % CO2.
Drift:
The requirement to drift ≤ 10 % of initial reading over the
calibration interval is fulfilled.

Continued on next page

8-8
TCM4/40 operator's manual 8. Specifications and ordering information

Specifications, Continued
Other approvals Item Description
and compliance pCO2 (continued) The following drift per hour has been measured at a sensor
(continued)
temperature of 43 °C:
Max. drift per hour at 5 % CO2: 2 %
Max. drift per hour at 10 % CO2: 2 %
Calibration interval: 4 hours
Accuracy:
The device indicates the partial pressure of carbon dioxide
(cutaneous pCO2) to within 5 mmHg over the measurement
range.
Response time (10 % to 90 % response):
The following max. response times have been measured at a
sensor temperature of 43 °C:
E5280/E5260: 26 seconds
E5480: 83 seconds
pO2 Non-linearity and hysteresis:
The requirement to non-linearity and hysteresis (±5 mmHg)
is fulfilled for gas concentrations between 2 % O2 and 20.9
% O2.
Drift:
The requirement to drift ≤ 5 % of initial reading over the
calibration interval is fulfilled.
The following drift per hour has been measured at a sensor
temperature of 43 °C:
Max. drift per hour at 10 % O2: 1 %
Max. drift per hour at 20.9 % O2: 1 %
Calibration interval: 4 hours
Accuracy:
The device indicates the partial pressure of oxygen
(cutaneous pO2) to within 5 mmHg over the range from 0 %
O2 to 20.9 % O2. In the range from 20.9 % O2 to full scale,
the accuracy is better than ±10 %.
Response time (10 % to 90 % response):
The following max. response times have been measured at a
sensor temperature of 43 °C:
E5280: 18 seconds
E5480: 26 seconds

Continued on next page

8-9
8. Specifications and ordering information TCM4/40 operator's manual

Specifications, Continued

Other approvals
and compliance Item Description
(continued) SpO2 Accuracy over 70 % to 100 %:
Sensor model: Weight range: Accuracy:
DS100A > 40 kg ±3 % SpO2
Oxiband A/N (adults) > 40 kg ±3 % SpO2
Oxiband A/N (neonates) < 3 kg ±4 % SpO2
Oxiband P/I 3-40 kg ±3 % SpO2
Test considerations and oximeter accuracy – Functional
testers and patient simulators
Some models of commercially available bench top
functional testers and patient simulators can be used to verify
the proper functionality of Nellcor pulse oximeter sensors,
cables and monitors. See the individual testing device's
operator's manual for the procedures specific to the model of
tester being used.
While such devices may be useful for verifying that the
pulse oximeter sensor, cable and monitor are functional, they
are incapable of providing the data required to properly
evaluate the accuracy of a system's SpO2 measurements.
Fully evaluating the accuracy of the SpO2 measurements
requires, at a minimum, accommodating the wavelength
characteristics of the sensor and reproducing the complex
optical interaction of the sensor and the patient’s tissue.
These capabilities are beyond the scope of known bench top
testers, including known devices which claim to measure
sensor LED wavelength.
SpO2 measurement accuracy can only be evaluated in vivo
by comparing pulse oximeter readings with values traceable
to SaO2 measurements obtained from simultaneously
sampled arterial blood using a laboratory CO-oximeter.
Many functional testers and patient simulators have been
designed to interface with the pulse oximeter's expected
calibration curves and may be suitable for use with Nellcor
monitors and/or sensors. Not all such devices, however, are
adapted for use with the Nellcor OXIMAX digital calibration
system. While this will not affect use of the simulator for
verifying system functionality, displayed SpO2 measurement
values may differ from the setting of the test device.
For a properly functioning monitor, this difference will be
reproducible over time and from monitor to monitor within
the performance specifications of the test device.
Pulse Accuracy: ±3 bpm over 20-250 bpm range

Continued on next page

8-10
TCM4/40 operator's manual 8. Specifications and ordering information

Specifications, Continued

Other approvals Item Description

and compliance
(continued) Known sources of tcpCO2/tcpO2:
interference After an hour's exposure, halothane (4 % evaporated into
carrier gas) will interfere with the tcpO2 readings of the
sensor and thereby also influence the combined effects of
non-linearity and hysteresis (beyond ±6 mmHg/±0.8 kPa).
Furthermore, if the patient is treated with Halothane, this
may cause changes in the skin blood flow and in this way
interfere with the tcpO2 readings.
Halothane does not affect the tcpCO2 readings.
The following substances have been tested and shown not to
influence the combined effects of non-linearity and
hysteresis (within ±6 mmHg/±0.8 kPa):
• Nitrous oxide (in a gas mixture of 60 % N2O, 5 % CO2,
20.9 % O2, balance N2). In the following referred to as
carrier gas.
• Enflurane: 5 % evaporated into carrier gas.
• Isoflurane: 5 % evaporated into carrier gas.
• Sevoflurane: 5 % evaporated into carrier gas.
• Desflurane: 12 % evaporated into carrier gas.
SpO2:
Inaccurate measurements can be caused by:
• prolonged patient movement
• venous pulsations
• intravascular dyes, such as indocyanine green or
methylene blue
• defibrillation
• incorrect application of the sensor
• placement of the sensor on an extremity with a blood
pressure cuff, arterial catheter or intravascular line
• ambient light
Loss-of-pulse signal can occur for the following reasons:
• The sensor is applied too tightly
• A blood pressure cuff is inflated on the same extremity as
the one with the sensor attached
• There is arterial occlusion proximal to the sensor

Continued on next page

8-11
8. Specifications and ordering information TCM4/40 operator's manual

Specifications, Continued

Other approvals Item Description

and compliance
(continued) Biocompatibility Fixation ring:
The suitability of the fixation ring adhesives for use on intact
human skin is supported by a series of in vitro and in vivo
evaluations.
The fixation ring adhesives meet the requirements of ISO
10993-1, "Biological Evaluation of Medical Devices. Part 1:
Evaluation and Testing" for surface devices contacting intact
human skin. The evaluations include cell cytotoxicity, skin
irritation and sensitization potential.
Nellcor SpO2 sensors (TCM40 only):
The sensors have passed the recommended biocompatibility
testing and are therefore in compliance with ISO 10993-1.

Patents One or more of the following patents and patent applications may apply:
• US Patent No.: US7,474,908
• US Patent Application No.: US2007/0238943
• European Patent Application Nos.: EP1753343, EP2007272
• Japanese Patent Application No.: JP2007/537799
• Chinese Patent Application No.: CN1988849
• International Patent Application No.: WO2007/115568
Other patents pending

Materials and Item Description

accessories All materials and All materials and accessories are latex-free
accessories

E5480 sensor Item Description

Dimensions Diameter:
• Sensor housing: 15 mm 0.6 in
• Silver body: 8.1 mm 0.32 in
Height: 7.81 mm 0.3 in
Weight: 2.6 g 0.08 oz
Sensor cable Length: 2.25 m 88.6 in

Continued on next page

8-12
TCM4/40 operator's manual 8. Specifications and ordering information

Specifications, Continued

E5280 and Item Description

E5260 sensors
Dimensions Diameter:
• Sensor housing: 15 mm 0.6 in
• Silver body: 9.1 mm 0.36 in
Height: 11.3 mm 0.44 in
Weight: 2.9 g 0.1 oz
Sensor cable Length: 2.25 m 88.6 in

OxiMax sensors Item Description

Dissipation 52.5 mW
Wavelength The wavelength range of the light emitted is near 660 nm
and 890 nm.

8-13
8. Specifications and ordering information TCM4/40 operator's manual

Accessories

TCM4/40 Description Code no.

systems
accessories E5480 tcpCO2/tcpO2 sensor (tinyTeddy) 945-660
E5280 tcpCO2/tcpO2 sensor 945-377
E5260 tcpCO2 sensor 945-655
Membraning kit for E5480 sensor, containing: 905-805
• tcpCO2/tcpO2 electrolyte solution
• 10 membraning tools
• Cleaning paper, bag with 5 pieces
Membraning kit for E5280 and E5260 sensors, containing: 904-892
• tcpCO2/tcpO2 electrolyte solution
• 12 green membrane units with PP membrane
• O-ring remover key
• Cleaning paper, bag with 20 pieces
Fixation kit for E5480 sensor, containing: 905-836
• 4 × 25 disposable fixation rings
• 4 × 20 mL contact liquid
Fixation kit for E5280 and E5260 sensors, containing: 904-891
• 4 × 25 disposable fixation rings
• 4 × 20 mL contact liquid
Large fixation ring for E5480 tcpCO2/tcpO2 sensor (tinyTeddy) 905-901

SpO2 Description Code no.

starter kits
SpO2 module with Nellcor DS100A sensor 902-876
SpO2 module with Nellcor Oxiband A/N sensor 902-877
SpO2 module with Nellcor Oxiband P/I sensor 902-878
SpO2 module without sensor 902-946

TCM4/40 Item Code no.

documentation
TCM4/40 operator's manual, English 990-277

Continued on next page

8-14
TCM4/40 operator's manual 8. Specifications and ordering information

Accessories, Continued

Line cords Description Code no.

Line cord 120 V, USA and JPN 615-407
Line cord 230 V, UK 615-312
Line cord 230 V, ITA 615-313
Line cord 230 V, ISR 615-315
Line cord 230 V, other 230 V countries 615-303
Line cord 230 V, AUS and NZA 615-317
Line cord 230 V, ZAF and IND 615-318

Additional Description Code no.

items
Extension cable for tcpCO2/tcpO2 sensor, 3 m (118.1 in) 617-853
Extension cable for tcpCO2/tcpO2 sensor, 6 m (236.2 in) 617-864
TCM4xx ETX Serial Adapter 636-649
TCM4xx ETX Analog Adapter 636-650
TCM4xx ETX VueLink Adapter 636-651
tcpCO2/tcpO2 module 902-778
Calibration chamber gasket for E5480 sensor 837-488
Calibration chamber gasket for E5280 and E5260 sensors 837-159
CAL1 standard calibration gas: 7.5 % CO2, 20.9 % O2, balance 962-187
N2, 180 mL
CAL1 standard calibration gas: 7.5 % CO2, 20.9 % O2, balance 962-188
N2, 180 mL (US and Canada)
CAL2 standard calibration gas: 10 % CO2, balance N2, 999 mL 962-096
NOTICE: Not applicable in Germany.
CAL2 standard calibration gas: 10 % CO2, 1 L 962-154
NOTICE: Only applicable in Germany.
Valve key (for CAL2 gas) 922-509
Gas adapter (for CAL2 gas) 847-398
Gasket for adapter (847-398) 837-487
12 V 2AH lead-acid battery 431-018

8-15
8. Specifications and ordering information TCM4/40 operator's manual

8-16
 9. Functional description

tcpCO2/tcpO2 measurement.................................................................................9-2
Construction of sensors ......................................................................................... 9-3
pCO2 measuring principle ..................................................................................... 9-5
pO2 measuring principle........................................................................................ 9-6
Calibration of sensor ............................................................................................. 9-7
Solutions and calibration gases ........................................................................... 9-10
Traceability certificates....................................................................................... 9-11
Pulse oximetry measurement ............................................................................9-15
Measuring principle ............................................................................................ 9-16
Calibration of sensor ........................................................................................... 9-17
9. Functional description TCM4/40 operator's manual

tcpCO2/tcpO2 measurement

Construction of sensors ............................................................................................ 9-3

pCO2 measuring principle ........................................................................................ 9-5
pO2 measuring principle........................................................................................... 9-6
Calibration of sensor ................................................................................................ 9-7
Solutions and calibration gases .............................................................................. 9-10
Traceability certificates.......................................................................................... 9-11

9-2
TCM4/40 operator's manual 9. Functional description

Construction of sensors

Sensor The tcpCO2/tcpO2 sensors (E5480 and E5280) combine a heating element, two
components temperature sensors, a Clark-type oxygen electrode, and a Severinghaus-type
carbon dioxide electrode in a single unit.

E5480 sensor
components

1 8

5 7
3 2
4 6

Number Component
1 NTC resistors – temperature sensors
2 Platinum cathode (pO2 part)
3 Electrolyte covering the sensor surface
4 CO2/O2-permeable membranes
5 Reinforced solid-state glass electrode (pCO2 part)
6 Ag/AgCl reference electrode
7 Electrolyte reservoir
8 Heating element

Continued on next page

9-3
9. Functional description TCM4/40 operator's manual

Construction of sensors, Continued

E5280 sensor
components

NOTICE: The single tcpCO2 sensor (E5260) is identical to the tcpCO2/tcpO2

sensor (E5280) except that it does not contain an active platinum cathode (the pO2
part).

Number Component
1 NTC resistors – temperature sensors
2 Platinum cathode (pO2 part)
3 Electrolyte covering the sensor surface
4 CO2/O2-permeable membranes
5 Reinforced solid-state glass electrode (pCO2 part)
6 Ag/AgCl reference electrode
7 Electrolyte reservoir
8 O-rings to secure the membranes
9 Heating element

NTC resistors The temperature of the sensor is measured by the NTC resistors incorporated in the
Ag/AgCl reference electrode. Due to the high thermal conductivity of the silver
body, the NTC resistors respond quickly to any changes in temperature. The
thermostatting system will keep the sensor at the preset temperature.

Local When the sensor is attached to the skin, the generated heat is transferred from the
vasodilation heating element via the silver body to the skin surface. The heat produces local
vasodilation and increases the permeability of the skin to oxygen and carbon
dioxide, thus making a measurement on the skin surface possible.

9-4
TCM4/40 operator's manual 9. Functional description

pCO2 measuring principle

Definition The measurement of pCO2 is defined as the partial pressure (or tension) of carbon
dioxide. It is performed by means of a Stow-Severinghaus electrode based on an
electrochemical electrode chain consisting of a pH glass electrode (the sensor
electrode) and a silver chloride reference electrode.

Measuring As CO2 is released from the skin, it diffuses through the membrane into the
principle electrolyte, where it reacts with water forming carbonic acid, which immediately
dissociates into HCO 3− and H+ according to the following equation:

H 2 O + CO 2 H 2 CO 3 H + + HCO 3−

The changes in H+ in the electrolyte imply changes in pH.

As the pH in the electrolyte changes, the voltage between the glass electrode and
the reference electrode changes. The pH change is converted to a pCO2 reading on
the basis of the linear relationship between pH and log pCO2, as expressed by the
Henderson-Hasselbalch equation:

pH = pK + log
[HCO ] −
3
a × pCO 2

where

pK = dissociation constant of carbonic acid

[ HCO ] =
−
3 concentration of HCO 3−

a = solubility coefficient of dissolved CO2

pCO2 = partial pressure of CO2

As no charged molecules can penetrate the membrane, the change in pH is strictly

due to the carbon dioxide diffusion into the electrolyte.
The potential measured across the combined electrode chain is fed into the pCO2
channel, where it is digitized. The digitized signal is then passed on to the
microcomputer, where it is converted to display pCO2 in mmHg or kPa.
The monitor is based on a microcomputer system in which all data obtained by the
sensor are collected, processed and compared with the alarm limits preselected in
the monitor's setup programs prior to presentation on the screen.

Severinghaus In most clinical settings, transcutaneous pCO2 monitoring is performed using the
temperature Severinghaus temperature correction factor.
correction
This means that the tcpCO2 readings are corrected to 37 °C (normal body
temperature), using the following formula:

tcpCO 2 (T) = pCO 2 (37 °C) × 10 −0.019(T − 37 °C)

where T is the set sensor temperature (°C).

9-5
9. Functional description TCM4/40 operator's manual

pO2 measuring principle

Definition The measurement of pO2 is defined as the partial pressure (or tension) of oxygen. It
is performed as a direct polarographic measurement based on an electrochemical
electrode chain consisting of the platinum cathode (the sensor electrode) and the
silver anode (the reference electrode).

Measuring The sensor tip is covered with a thin membrane which stabilizes the conditions of
principle pO2 diffusion to the sensor. Oxygen diffuses through this membrane to the cathode
where a reduction of oxygen occurs as a result of the current-generating process:
O2 + 2 H 2O + 4 e− 4 OH −
At the anode the following reaction takes place:
4 Ag + 4 Cl − → 4 AgCl + 4 e −
The reduction of oxygen at the platinum cathode generates a current, which is fed
into the pO2 channel, where it is converted into a voltage and digitized. This digi-
tized signal is then passed on to the microcomputer, where it is reconverted to
display pO2 in mmHg or kPa.

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TCM4/40 operator's manual 9. Functional description

Calibration of sensor

Temperature- In order for the calibration value to be within the normal physiological range for
corrected pCO2 tcpCO2, Radiometer uses a 7.5 % CO2 concentration in the calibration gas for the
values TCM4/40 monitors.
The 7.5 % CO2 calibration gas will give the following CO2 calibration value (at a
barometric pressure of 760 mmHg):
% CO 2 7 .5
pCO 2 (CAL) = B × = 760 × = 57 mmHg
100 100
When the Severinghaus temperature correction factor is activated (Severinghaus
corr. "ON"), the above pCO2 calibration value will result in the following
temperature-corrected pCO2 values:
Sensor
temp °C 37 38 39 40 41 42 43 44 45
Temperature
corr. factor 1.00 1.04 1.09 1.14 1.19 1.24 1.30 1.36 1.42
Temperature
corr. value,
mmHg* 57 55 52 50 48 46 44 42 40
57
* Temperature corr. pCO2 value =
Temp. corr. factor

Temp.corr.factor = 10 −0.019(T − 37 °C)

Gas calibration The monitor calculates the nominal dry gas tcpCO2 calibration values relative to
values the barometric pressure in accordance with the following formula:
% CO 2
p CO 2 (CAL) = B × , where
100
B = the barometric pressure in mmHg or kPa
% CO2 = the percentage of CO2 in the calibration gas (i.e. 7.5 %)

The monitor calculates the nominal dry gas tcpO2 calibration values relative to the
barometric pressure in accordance with the following formula:

% O2
p O 2 (CAL) = B × , where
100
B = the barometric pressure in mmHg or kPa
% O2 = the percentage of O2 in the calibration gas (i.e. 20.9 %)

Continued on next page

9-7
9. Functional description TCM4/40 operator's manual

Calibration of sensor, Continued

Calibration The calibration process includes the stages described in the table below:
process
CALIBRATION (max. duration 16 min)

Stage Description
Heating The sensor is typically heated to the preset temperature within
one minute. If it has not reached this temperature within three
minutes, the computer will reject the sensor, and the error
message "Calibration error. Sensor temperature error during
calibration." will be displayed.
Check of When the sensor reaches the preset temperature, the monitor
sensor checks the sensor pCO2 and pO2 signals. If these are not within a
signal range specified range within one minute, the monitor rejects the sensor,
and the error message "Calibration error. Sensor sensitivity error
during calibration." will be displayed.
NOTICE: The sensor may also be rejected because of an
incorrect calibration value.
Check of After heating and acceptance of the sensor signal range, the
stability monitor checks the sensor stability for maximum 10 minutes or
until the change in the sensor signal is below 1 % compared with
the signals registered one minute earlier. If, following this, the
stability criterion is still not fulfilled, the monitor will reject the
sensor, and the error message "Calibration error. Sensor drift
during calibration." will be displayed.
If the stability is accepted, the monitor will then display "Ready".

Continued on next page

9-8
TCM4/40 operator's manual 9. Functional description

Calibration of sensor, Continued

Patient safety In order to satisfy the requirements for patient safety, the circuitry that is
interconnected with the sensor is galvanically insulated from the rest of the system.
The monitor is equipped with an extensive safety system for controlling and
monitoring sensor temperature.
• The microprocessor program gives an audiovisual alert if the sensor temperature
deviates ±0.3 ºC from the preset value.
• The sensor power consumption is permanently supervised. If it exceeds
maximum effect for more than two minutes, the heat switches off.
• If the sensor temperature reaches 46 ºC or falls below 5 ºC, this could indicate a
short or an open circuit in the thermostatting control loop. In this case, the
monitor utilizes one of several hardware and software controls to immediately
and permanently switch off the sensor heating.
• If there is a temperature difference of more than 0.6 ºC between the two
thermistors, heating switches off immediately and permanently.
• If a software error occurs, a "watchdog" circuit in the monitor immediately and
permanently switches off the sensor heating.

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9. Functional description TCM4/40 operator's manual

Solutions and calibration gases

Solutions The following solutions are used with the TCM4/40 systems:
Solution Description
tcpCO2/tcpO2 Use: To be applied on the clean sensor surface.
electrolyte solution,
Composition: 1,2-propanediol, propanetriol, potassium
10 mL
chloride, potassium hydrogen carbonate and
deionized water.
Storage: At room temperature or below.
Stability: Expiration date and lot no. are printed on a
separate label on the bottle.
Contact liquid, Use: To establish contact between the skin and
20 mL the sensor during in vivo measurements.
Composition: 1,2-propanediol and deionized water.
Storage: At room temperature or below.
Stability: Expiration date and lot no. are printed on a
separate label on the bottle.
NOTICE: Keep the bottle caps on when bottles are not in use.

Calibration • CAL1 standard calibration gas (7.5 % CO2, 20.9 % O2 with N2 as balance)
gases
• CAL2 standard calibration gas (10 % CO2 with N2 as balance)

WARNING – Risk of explosion

Calibration gas cylinder: Contents under pressure. Do not puncture. Do
not use or store near heat or open flame. Exposure to temperatures above
54 °C (for CAL2) and 50 °C (for CAL1) may cause contents to vent or
cause bursting. Never discard container into fire or incinerator as it may
cause an explosion.
WARNING – Risk of explosion
Before discarding an empty CAL2 gas cylinder, remove the safety valve
using the valve key (code no. 922-509). If you do not do this, the
calibration gas cylinder may burst if exposed to heat.

9-10
TCM4/40 operator's manual 9. Functional description

Traceability certificates

9-11
9. Functional description TCM4/40 operator's manual

9-12
TCM4/40 operator's manual 9. Functional description

NOTICE: The below-mentioned CAL2 calibration gas is not applicable to Germany. For
information on the CAL2 calibration gas that applies to Germany, see next page.

9-13
9. Functional description TCM4/40 operator's manual

NOTICE: The below-mentioned CAL2 calibration gas applies to Germany only.

9-14
TCM4/40 operator's manual 9. Functional description

Pulse oximetry measurement

Measuring principle ............................................................................................... 9-16

Calibration of sensor .............................................................................................. 9-17

9-15
9. Functional description TCM4/40 operator's manual

Measuring principle

Introduction The monitor uses pulse oximetry to measure functional oxygen saturation in the
blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular
bed, such as a finger or toe. The sensor contains a dual light source and a
photodetector.
Bone, tissue, pigmentation and venous vessels normally absorb a constant amount
of light over time. The arteriolar bed normally pulsates and absorbs variable
amounts of light during the pulsations. The ratio of light absorbed is translated into
a measurement of functional oxygen saturation (SpO2).
Because a measurement of SpO2 is dependent upon light from the sensor, excessive
ambient light can interfere with this measurement.
Specific information about ambient conditions, sensor application and patient
conditions is contained throughout this manual.

Measuring Pulse oximetry is based on two principles: that oxyhemoglobin and

principles deoxyhemoglobin differ in their absorption of red and infrared light
(spectrophotometry), and that the volume of arterial blood in tissue (and hence,
light absorption by that blood) changes during the pulse (plethysmography). A
pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar
bed and measuring changes in light absorption during the pulsatile cycle. Red and
infrared low-voltage light-emitting diodes (LED) in the oximetry sensor serve as
light sources; a photodiode serves as the photodetector.
NOTICE: Information about the range of wavelength can be useful to clinicians in
particular. For information on the range of wavelength, see OxiMax sensors in the
section Specifications in chapter 8.
Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the
amount of red and infrared light absorbed by blood is related to hemoglobin
oxygen saturation. To identify the oxygen saturation of arterial hemoglobin, the
monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of
arterial blood enters the vascular bed, and blood volume and light absorption
increase.
During diastole, blood volume and light absorption reach their lowest point. The
monitor bases its SpO2 measurements on the difference between maximum and
minimum absorption (measurements at systole and diastole). By doing so, it
focuses on light absorption by pulsatile arterial blood, eliminating the effects of
non-pulsatile absorbers such as tissue, bone and venous blood.

Oxygen The monitor measures oxygen saturation, also called functional saturation
saturation vs (oxygenated hemoglobin expressed as a percentage of the hemoglobin that can
oxyhemoglobin transport oxygen). It does not detect significant amounts of dysfunctional
fraction hemoglobin, such as carboxyhemoglobin or methemoglobin. To compare oxygen
saturation measurements with those from an instrument that measures
oxyhemoglobin fraction, also erroneously called fractional saturation (oxygenated
hemoglobin expressed as a percentage of all measured hemoglobin, including
measured dysfunctional hemoglobins), oxyhemoglobin fraction must be converted
as follows:
oxyhemoglobin fraction
oxygen saturation = × 100
100 − (% carboxyhemoglobin + % methemoglobin)

9-16
TCM4/40 operator's manual 9. Functional description

Calibration of sensor

Description Because light absorption by hemoglobin is wavelength dependent and because the
mean wavelength of LEDs varies, an oximeter must know the mean wavelength of
the sensor’s red LED to accurately measure SpO2.
During monitoring, the monitor’s software selects coefficients that are appropriate
for the wavelength of that individual sensor’s red LED; these coefficients are then
used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the light intensity
of the sensor’s LEDs is adjusted automatically.

9-17
9. Functional description TCM4/40 operator's manual

9-18
TCM4/40 operator's manual Index

Index
indicator ................................... 2-3
A
level.......................................... 4-7
Accessories recharging................................. 4-7
additional items ...................... 8-15 Biocompatibility 8-12
fixation kit .............................. 8-14 Blood gas comparison 6-44
line cords ................................ 8-15 Blood gas values
membraning kit ...................... 8-14 calibrating transcutaneous
SpO2 starter kits...................... 8-14 measurements against ...3-13, 6-45
TCM4/40 documentation ....... 8-14 comparing transcutaneous
TCM4/40 systems .................. 8-14 measurements with........3-13, 6-44
Accuracy
C
pCO2 ......................................... 8-9
pO2 ........................................... 8-9 CAL1 9-10
pulse ....................................... 8-10 CAL2 9-10
SpO2 ....................................... 8-10 Calibration
Alarm automatic.................................. 5-2
pCO2 ....................................... 3-10 frequency.................................. 5-2
pO2 ......................................... 3-11 in vivo .................................... 6-45
Pulse ....................................... 3-12 manual...................................... 5-3
reset ........................................ 6-35 materials ................................... 5-2
SatSeconds ............................. 6-36 patient safety ............................ 9-9
silence..................................... 6-35 process...................................... 9-8
SpO2 ....................................... 3-12 recommendation....................... 5-2
tone......................................... 6-35 SpO2 sensor ............................ 9-17
VueLink ................................. 6-27 with calibration gas .................. 5-3
Alarm mode Calibration chamber 2-3
latching................................... 3-20 Calibration gas 9-10
non-latching ........................... 3-20 Calibration setup 3-14
Alarm sound level 3-12 Calibration status 3-16
Alarms 6-34 Calibration values 9-7
Alert Certificates of traceability 9-11
tone......................................... 6-36 Changing
VueLink ................................. 6-27 battery ...................................... 4-7
Alerts 6-34, 6-35 gas bottle .................................. 4-8
All rights reserved 1-2 gasket in calibration chamber... 4-8
Ambient light sources 6-5 Cleaning
Ambient temperature 4-2 cable ....................................... 4-15
Analog output 2-4, 6-21 E5480 sensor head ................. 4-11
Analog range exterior ..................................... 4-6
pCO2 ....................................... 3-21 sensor head............................. 4-15
pO2 ......................................... 3-21 SpO2 sensors .......................... 4-16
Anemia 6-4 soak method ....................... 4-16
Application of sensor wipe method....................... 4-16
DS100A.................................... 6-9 touch screen.............................. 4-6
E5260 ....................................... 6-7 Combi module 2-3
E5280 ....................................... 6-7 Common name 1-2
E5480 ....................................... 6-6 Compliance 8-8
Oxiband A/N and P/I................ 6-9 Connecting to
external chart recorder ........... 6-21
B
external equipment................... 4-3
Battery 2-4, 4-7 external PC....................6-22, 6-30
change ...................................... 4-7 polysomnograph..................... 6-21
Index TCM4/40 operator's manual

PPMS monitor........................ 6-24 PC........................................... 6-30

printer ..................................... 6-38 External chart recorder 6-21
Construction of sensors 9-3
F
Contact liquid 6-7, 9-10
Continuous data output 3-20, 6-22 Factory defaults 3-23
MonLink................................. 6-29 Fixation kit 6-6
standard .................................. 6-22 Fixation ring 6-7
VueLink ................................. 6-24 Flammable anesthetics 4-2
CSA 8-7 Front view 2-3
Cursor 6-19 Functional oxygen saturation 9-16
Curve report 6-41, 6-43 G
D Gas adapter 8-15
Data dump 6-30, 6-33 Gas bottle
Data export 6-30 maintenance ............................. 4-8
serial ....................................... 6-30 Gas calibration values 9-7
USB........................................ 6-33 Gas level 3-16, 5-3
Data Management System 6-13 Gas status 5-3
Date/time settings 3-22 Gasket
Default values 3-23 change of .................................. 4-8
Dialog box messages 7-6 H
Disinfection
outer surfaces ........................... 4-6 Handle 2-3
sensor ..................................... 4-15 Henderson-Hasselbalch equation
Disinfection solutions 4-15 9-5
Display brightness 3-21 High-frequency electrical signals
Documentation 8-14 6-3
Drift Hyperbaric chamber 4-2, 6-3
pCO2 ......................................... 8-8 HyperTerminal 6-22, 6-30
pO2 ........................................... 8-9 Hyperthermia 6-3
Dysfunctional hemoglobins 6-4 I
E Importing data files into Microsoft
E5260 sensor components 9-4 Excel 6-31
E5280 sensor components 9-4 In vivo calibration 3-20, 6-45
E5480 sensor In vivo monitoring 6-11
membraning ........................... 4-12 Inaccurate measurements 6-4,
E5480 sensor components 9-3 6-5, 8-11
E5480 sensor head Installation 4-3
cleaning .................................. 4-11 Intended use 1-2
Electrocautery 6-3 Interference
Electrolyte solutions 9-10 from ambient light.................... 6-5
EMC approvals and compliance 8-4 known sources........................ 8-11
Enriched oxygen atmosphere 4-2, K
6-3
Environment of use 1-2 Keyboard 6-15
Environmental requirements 4-2 L
Error messages 7-3
SpO2 ......................................... 7-6 Latching alarm 6-34
tc.................................................... Light absorption 9-16
.................................................. 7-3 Line fuse 2-4
Event 6-11 Linking session 6-12
Excel 6-23, 6-30 Local vasodilation 9-4
Exporting data to Loss-of-pulse signal 6-4, 6-5, 8-
memory stick.......................... 6-33 11
TCM4/40 operator's manual Index

M P
Main screen Parameter setup 3-9
when not activated for Parameters
30 seconds .........................3-2, 3-5 pCO2 ....................................... 3-10
Markings pO2 ......................................... 3-11
normal view............................ 6-17 Pulse ....................................... 3-12
trend curve.............................. 6-20 SpO2 ....................................... 3-12
trend table............................... 6-18 Parts and functions
Measurement rear ........................................... 2-4
pCO2 ......................................... 9-5 top and front ............................. 2-3
pO2 ........................................... 9-6 Patents 8-12
SpO2 ....................................... 9-16 Patient DMS 6-12, 6-13
Measuring principle Patient ID 6-12, 6-13
pCO2 ......................................... 9-5 Patient monitoring 6-11
pO2 ........................................... 9-6 Patient movement 6-5
SpO2 ....................................... 9-16 Patient safety 8-7
Measuring sites 6-2 Patient stabilization time 6-11
Membraning 4-10 PCL-compatible PC printer 6-38
E5260 sensor .......................... 4-13 pCO2
E5280 sensor .......................... 4-13 measurement ............................ 9-5
E5480 sensor .......................... 4-12 measuring principle.................. 9-5
Menu screen sensitivity ................................. 5-4
configuration ............................ 2-7 pCO2 3-10
touch keys ................................ 2-7 pCO2 alarm
Menu structure 3-2 high ........................................ 3-10
Meta. corr. factor 3-20 low.......................................... 3-10
Module release 2-4 Performance considerations
Modules SpO2 sensors ............................ 6-5
SpO2 ......................................... 2-3 TCM40 monitor ....................... 6-5
tcpCO2/tcpO2 ............................ 2-3 Philips Patient Monitoring System
MonLink 6-29 6-24
Photodetector 9-16
N
Photodiode 9-16
Name 1-2 Physiological alarms 6-34
Nominal dry gas calibration values Plethysmography 9-16
9-7 pO2 3-11
Non-latching alarm 6-34 measurement ............................ 9-6
Non-linearity and hysteresis measuring principle.................. 9-6
pCO2 ......................................... 8-8 zero current .............................. 5-4
pO2 ........................................... 8-9 pO2 alarm
Normal view 3-5, 6-16 high ........................................ 3-11
NTC resistors 9-4 low.......................................... 3-11
O pO2 parameter only 3-20
Polysomnograph 6-21
On-screen keyboard 6-15 Power socket 2-4
Operating requirements 4-2 Power switch 2-4
Operator profile 1-2 PPMS monitor 6-24
O-ring 4-13 configuration .......................... 6-27
O-ring remover 4-13 Print reports 6-43
Oxygen saturation Printer setup 3-17
fractional ................................ 9-16 Printer type 3-18
functional ............................... 9-16 Printing 6-38
Oxygenated hemoglobin 9-16 USB ports............................... 6-38
Oxyhemoglobin fraction 9-16 Printouts 3-18
Index TCM4/40 operator's manual

Proprietary name 1-2 temperature............................... 6-2

Pulse alarm Sensor application procedure
high......................................... 3-12 DS100A.................................... 6-9
low.......................................... 3-12 E5260 ....................................... 6-7
Pulse oximetry E5280 ....................................... 6-7
measuring principles .............. 9-16 E5480 ....................................... 6-6
Pulse rates 6-4 Oxiband A/N and P/I................ 6-9
Pure text messages 7-8 Sensor components
E5260 ....................................... 9-4
R
E5280 ....................................... 9-4
Rear view 2-4 Sensor components
Recharging battery 4-7 E5480 ....................................... 9-3
Relative humidity 4-2 Sensor socket
Remembraning 4-10 SpO2 ......................................... 2-4
Removal of wraps 6-10 tcpCO2/tcpO2 ............................ 2-4
Report Sensor temperature 3-10, 3-11
curve....................................... 6-41 Serial port (RS232) 2-4
table........................................ 6-39 Session 6-12, 6-13
Requirements Session number 6-13
ambient temperature................. 4-2 Setting up
environmental........................... 4-2 analog output.......................... 6-21
operating................................... 4-2 Setup programs 3-3
relative humidity ...................... 4-2 Printer..................................... 3-17
ventilation................................. 4-2 Severinghaus corr. 3-20
Response time Severinghaus temperature correction
pCO2 ......................................... 8-9 9-5
pO2 ........................................... 8-9 Shutting down 4-5
Results Site time 3-10, 3-11, 6-11
Normal view........................... 6-16 Site time heat 3-10, 3-11
Trend curve view.................... 6-19 SmartCal 3-15, 5-2
Trend table view..................... 6-18 SmartHeat 3-10
S Solutions
composition............................ 9-10
SatSeconds 3-12, 6-36 stability................................... 9-10
safety net ................................ 6-37 storage .................................... 9-10
Saturation 6-4, 9-16 use .......................................... 9-10
Saturation monitoring 6-8 Specifications
E5260 sensor .......................... 8-13
Screen E5280 sensor .......................... 8-13
general elements....................... 2-5 E5480 sensor .......................... 8-12
menu......................................... 2-5 monitor ..................................... 8-2
types ......................................... 2-5 OxiMax sensors...................... 8-13
view.......................................... 2-5 Spectrophotometry 9-16
when not activated for SpO2
30 seconds .........................3-2, 3-5 measurement .......................... 9-16
Screen saver 3-6, 3-21 measuring principles .............. 9-16
Sensor module.................................... 9-16
E5480 ....................................... 6-6 sensor performance
Sensor considerations........................... 6-5
DS100A.................................... 6-9 SpO2 alarm
E5260 ....................................... 6-7 high ........................................ 3-12
E5280 ....................................... 6-7 low.......................................... 3-12
Oxiband A/N ............................ 6-9 SpO2 module 2-3
Oxiband P/I .............................. 6-9 SpO2 monitoring
storage .................................... 4-15 required materials..................... 6-8
TCM4/40 operator's manual Index

Stabilization time of patient 6-11 errors ........................................ 7-2

Standard calibration gas 5-4 pure text messages ................... 7-8
Standard data output 6-22 recommended operator actions 7-2
Storage of sensor 4-15 symptoms ................................. 7-2
Symbols Tutorials 2-6, 2-8
used in the manual.................... 1-6
U
used on the monitor.................. 1-4
USB 6-33
T
USB ports 2-4, 6-38
Table report 6-39, 6-40
V
TCM4 Series monitoring system
1-2 Valve key 8-15
TCM4/40 monitoring systems 1-2 Ventilation requirements 4-2
TCM40 View screen
performance considerations ..... 6-4 configuration ............................ 2-5
TCM40 SpO2 module 9-16 touch keys ................................ 2-6
tcpO2/tcpCO2 electrolyte solution View setup 3-4
9-10
Technical alarms 6-34 Views
Technical settings 3-20 Normal ..................................... 3-5
Technical setup 3-19 Trend curve .............................. 3-8
Temperature, sensor 6-2 Trend table ............................... 3-7
Time settings 3-22 VueLink 6-24
Touch key glossary 2-9 W
Touch screen 2-3
Traceability certificates 9-11 Waste of Electrical and Electronic
Trend curve view 3-8, 6-19 Equipment 1-4
Trend table view 3-7, 6-18 WEEE 1-4
Troubleshooting What is what 2-1
cause of error............................ 7-2 Z
dialog box messages................. 7-6
error messages.......................... 7-3 Zero current 5-4
Index TCM4/40 operator's manual
TCM4/40 operator's manual Date of issue

Date of issue

Radiometer representative: Manufacturer:

Radiometer Medical ApS

Åkandevej 21
If you have any questions or need 2700 Brønshøj
assistance, please contact your local Denmark
Radiometer representative. www.radiometer.com

TCM4/40 monitoring systems

operator’s manual
from software version 3.00

Publication 201101
Edition C
Code number 994-941