TCM400 Operators Manual Sw Ver 5.00 Edition Q

What is new in this manual? Update for software version 5.0

The TCM400 operator’s manual has been updated with information on the following: • Checking the sensor zero current

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 TCM400 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. 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, AQURE, PICO, CLINITUBES and QUALICHECK are trademarks of or used under license by Radiometer Medical ApS. © 2013 Radiometer Medical ApS. All rights reserved.

End user license agreement for TCM400 monitors The installed software comprises Microsoft Windows CE and Radiometer-developed programs. Each program is licensed, not sold, to you, to be used only under the terms of this agreement and the Microsoft end user license agreement. Radiometer Medical ApS and its licensor reserve all rights not expressly granted to you. You may use the software only with the instrument in which it is installed for your internal purposes and only transfer the software to others as installed with the instrument and with the end user license agreements included in the operator's manual. The software may not be copied. You may not modify, reverse engineer, decompile or disassemble the programs. By your use of the instrument you agree to the terms of this agreement and the Microsoft end user license agreement. If you do not accept or agree to the terms, you should switch off the instrument promptly, and contact your Radiometer representative for a return of the instrument and a refund of your money.

End user license agreement for Microsoft Software •

You have acquired a device (”TCM400 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 environmental damage. Sun Microsystems, Inc. has contractually obligated MS to make this disclaimer.



No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U.S. TWO HUNDRED FIFTY DOLLARS (U.S.$250.00).



Limitations on reverse Engineering, Decompilation, and Disassembly. You may not reverse engineer, 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 EULA. If the SOFTWARE is an upgrade, any transfer must also include all prior versions of the SOFTWARE.



EXPORT RESTRICTIONS. You acknowledge that SOFTWARE is of US-origin. You are to comply with all applicable international and national laws that apply to the SOFTWARE, including the U.S. Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and other governments. For additional information on exporting the SOFTWARE, see http://www.microsoft.com/exporting/.

TCM400 operator's manual

Contents

Contents Introduction

This manual describes how to operate the TCM400 system and covers the following chapters and topics:

1. Introduction ... 1-1 Overview ... 1-1 Name, intended use and limitations ... 1-2 Warnings, cautions and notes ... 1-3 2. What is what ... 2-1 Overview ... 2-1 TCM400 monitor – front ... 2-2 TCM400 monitor – rear ... 2-4 The screen: general elements ... 2-5 Online tutorials... 2-7 The touch key glossary ... 2-8 3. Menu structure and setup programs ... 3-1 Overview ... 3-1 Menu structure ... 3-2 The change view program ... 3-3 Normal view ... 3-4 Trend table view ... 3-5 Trend curve view ... 3-6 The setup program ... 3-7 User setup ... 3-8 Technical setup ... 3-11 Default settings ... 3-13 4. Installation and maintenance ... 4-1 Overview ... 4-1 Operating requirements ... 4-2 Installing the monitor ... 4-3 Shutting down the monitor... 4-8 Cleaning the monitor... 4-9 Preparation and maintenance of the electrode ... 4-10 5. Calibration ... 5-1 Overview ... 5-1 General information ... 5-2

Contents

TCM400 operator's manual

Calibration with atmospheric air ... 5-2 Checking the electrode zero current... 5-5 6. In vivo monitoring ... 6-1 Overview ... 6-1 General Information ... 6-2 In vivo monitoring ... 6-4 Trend table view ... 6-13 Trend curve view ... 6-16 How to print ... 6-11 Serial data output: standard ... 6-24 Serial data output: data export ... 6-29 7. Troubleshooting ... 7-1 Overview ... 7-1 The monitor... 7-2 8. Specifications and ordering information ... 8-1 Overview ... 8-1 Specifications ... 8-2 Accessories ... 8-12 9. Functional description... 9-1 Overview ... 9-1 The tcpO2 electrode... 9-2 Measurement ... 9-3 Calibration ... 9-4 Solutions and calibration gas ... 9-6 Traceability certificate ... 9-7 Index Date of issue

1. Introduction Overview Introduction

This chapter describes the intended use of the TCM400 system. It also contains the definitions of warnings, cautions and notices.

In this chapter

This chapter covers the following topics: Overview ... 1-1 Name, intended use and limitations ... 1-2 Symbols used in the manual ... 1-3

1. Introduction

TCM400 operator's manual

Name, intended use and limitations Proprietary name

TCM400 Transcutaneous pO2 Monitoring System.

Common name

Multichannel tcpO2 monitor or TCM400 system.

TCM4 Series monitors

The TCM400 system is part of the TCM4 Series monitoring system.

Reference

This operator’s manual for the TCM400 Transcutaneous pO2 Monitoring System is intended for use as a reference. It provides detailed operating instructions and answers to relevant questions about your transcutaneous system.

All rights reserved

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

Intended use

The TCM400 system is a device that uses up to six non-invasive sensors placed on the patient's skin and that is intended to record transcutaneous oxygen partial pressures in adults not under gas anesthesia. Do not use the TCM400 system in intensive care (ICU, NICU, etc.) for unattended patient monitoring, as the system has no alarms.

Measuring range

Transcutaneous measurements of tcpO2 can be performed at levels from 0 to 2000 mmHg (0 to 266.7 kPa).

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 poor correlation with arterial values If tcpCO2/tcpO2 monitoring is used on patients in a hemodynamic state of compromised peripheral circulation, this may cause poor correlation between transcutaneous and arterial values. 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 notice

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Instruments should be repaired by Radiometer service personnel or by Radiometer-certified representatives only.

TCM400 operator's manual

1. Introduction

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.

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1. Introduction

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TCM400 operator's manual

2. What is what Overview Introduction

The transcutaneous pO2 monitoring system includes: • the TCM400 monitor • the tcpO2 sensor (E5250) This chapter identifies the parts of the TCM400 monitor.

In this chapter

This chapter covers the following topics: Overview ... 2-1 TCM400 monitor – front... 2-2 TCM400 monitor – rear ... 2-4 The screen: general elements ... 2-5 Online tutorials ... 2-7 The touch key glossary... 2-8

2. What is what

TCM400 operator's manual

TCM400 monitor – front Handle

Front view

Touch screen

Calibration chambers

Sensor modules

Battery indicator Button Monitor support and holder for sensor cables

Parts and functions

Monitor-elevating support

The following table lists the parts located on the front of the TCM400 monitor: Part

Function

Handle

For carrying the monitor.

Calibration chambers

For sensor storage and calibration.

Touch screen

Facilitates communication between operator and monitor.

Sensor modules

For transcutaneous measurements of tcpO2. The TCM400 monitor can contain up to six modules – see the configuration below.

Monitor support and holder for sensor cable

The support of the monitor has the capability of holding the sensor cables.

Monitor-elevating support

For supporting the monitor at an elevated angle.

button

Battery indicator

For turning the monitor ON and OFF. For indicating whether the battery is being recharged or not. If the light is on, the battery is being recharged. NOTICE: Only possible if the power switch on the back of the monitor is in the ON () position. Continued on next page

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TCM400 operator's manual

2. What is what

TCM400 monitor – front, Continued Sensor module configurations

The TCM400 monitor allows placement of the sensor modules in many different combinations. Example: Six sensor modules: 1

4

2

5

3

6

Example: Four sensor modules:

Automatic numbering

1

3

2

4

The TCM400 monitor will automatically give each module/sensor a number when mounted. The first module from the left will be given number 1, and this sensor will always be the reference for the other sensors when calculating the Regional Perfusion Index, RPI. This means that RPI can only be calculated if there is a module placed in position 1. Example: Four sensor modules: 1

3

2

4

The Regional Perfusion Index, RPI, is calculated as follows: Regional Perfusion Index RPI = tcpO2(other module) / tcpO2(reference module 1)

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2. What is what

TCM400 operator's manual

TCM400 monitor – rear Rear panel Battery

Sensor socket

Module release Line fuse Power switch Power socket

Ethernet

Parts and functions

Serial port

USB ports

The following table lists the parts located on the rear of the TCM400 monitor: Part

Function

Battery

For full functionality, the battery must be installed in the TCM400 monitor. It enables monitoring and storage of data during transport and prevents data loss in the event of a power failure.

Sensor socket

For connecting the sensor to the monitor.

Power socket

For connecting a power cord to the TCM400 system.

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.

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.

Ethernet (serial port)

For connecting the TCM400 system to the communication system. NOTICE: Not yet available.

Serial port (RS232)

For connecting the TCM400 system to an external computer.

USB ports

For connecting the TCM400 system to an external printer. NOTICE: It is only possible to use one of the ports at a time.

Module release

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For releasing the sensor module from the monitor with a release key.

TCM400 operator's manual

2. What is what

The screen: general elements There are three types of view screen (Normal, Trend table and Trend curve), and they are all divided into the following fields:

The screen configuration

Headline Sensor display

Touch keys

Example of Normal view screen in Ready mode

Red

Green

Blue

Yellow

Orange

Purple

Touch keys

NOTICE: In Normal view, the Event touch key replaces the Tutorial touch key during Measuring mode. Headline field

The headline field contains the following information: Part

Shows

Time and date

The real time (24-hour cycle) and date

System status

Ready, Measuring, Calibrating or Calibration required.

Battery level indicator

Shows the battery level. The indicator is only visible when the monitor is running on battery power alone. For more details, see Chapter 4, Installation and maintenance.

ID

Full , almost full , low and critically low Patient identification number. Serves as a shortcut to the Patient DMS. Continued on next page

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2. What is what

TCM400 operator's manual

The screen: general elements, Continued Sensor display field

The sensor display field contains the following information: Part One to six sensor modules

Shows Data presented as: • Numerical values (normal view) • Trend tables • Trend curves

Trend arrows

An upward/downward arrow will appear next to the result on the Normal view screen when an upward/downward trend in measuring values is detected.

Preset temp

The preset sensor temperature in each sensor display during Ready and Calibration required modes. NOTICE: If the sensor temperature exceeds the preset temperature, a text message appears in the sensor display.

Touch key field

Baro pressure

The measured barometric pressure during calibration.

pO2 cal value

The calculated pO2 value for calibration.

Sensor status

The status of the individual sensor, e.g. Ready, Calibration required, Calibrating, No sensor connected, etc., or an error status.

Power

Sensor power in mW.

The touch key field contains the following touch keys: Touch Key

Function

Timer

To enter the Timer screen. Shows the actual countdown timer and its interval when active.

Calibrate

To start a calibration of all sensors.

Print

To print the measurement results.

Setup

To enter the Setup and View programs.

Event

To mark an event during monitoring. Only visible in Measuring mode and in the Trend table and Curve views.

Tutorial

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To access instruction videos.

TCM400 operator's manual

2. What is what

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 touch key.

Touch keys

Touch key

Function Pauses the selected tutorial. Plays the selected tutorial.

and

Scroll backward/forward one step in the selected tutorial. Returns to the TCM Tutorials screen. Exits the tutorial and returns to Normal view.

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2. What is what

TCM400 operator's manual

The touch key glossary Touch key symbols

Touch keys are designated in bold italic throughout this 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 To add a check mark to the highlighted patient ID/session number (in Patient DMS). To see detailed information about the highlighted patient ID/session number (in Patient DMS). To set the printer start time and stop time. To select SmartPrint. To print one or more reports from the Patient DMS.

Advanced

To select printout of: • Events only, Timer active only and/or Print in color • pO2, RPI or Power

Auxiliary setup

To change backlight, calibration gas mixture, humidity correction factor, pO2 unit, serial output and date/time setup, or to bypass calibration.

Bypass calibration To bypass the calibration in progress and force the monitor into Ready mode. NOTICE: If a calibration is bypassed, the monitor will be monitoring with invalid data. The option should therefore only be used for service purposes. Calibrate

To start a calibration of all sensors.

Cancel

To return to the previous screen without making changes.

Change ID

To change the highlighted patient ID/session number (in Patient DMS) with the on-screen keyboard.

Change view

To change the view of your data to Normal, Trend table or Trend curve view, and to enter the view options.

Close

To close the Timer dialog box.

Cursor

Adds/removes a cursor in the Trend curve view.

Curve scales

To change scales for tcpO2, power or RPI.

Curve view

To change to Trend curve view.

Date/time

To adjust Date/time settings.

Delete

To delete the patient IDs/session numbers with a check mark (in Patient DMS). Continued on next page

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TCM400 operator's manual

2. What is what

The touch key glossary, Continued Touch key symbols (continued)

Touch key

Function

Delete all

To delete all patient IDs/session numbers in the list (in Patient DMS).

Edit list

To edit the list of textual events.

Sensor no.

To start calibration of a single sensor.

Event

To mark an event during monitoring. To see which text is connected to which event number.

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 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.

Normal view

To change to Normal numerical view.

OK

To accept the setting(s)/change(s) and return to the previous screen.

Printer setup

To enter Printer setup.

Reset

To reset the timer to 00:00.

Restore default

To restore all settings to default.

Start/stop timer

To start or stop the timer.

Start x min

To start one of the countdown timers.

Self-check

To perform self-check (see the service manual).

Service mode

To enter the Service program (see the service manual).

Setup

To enter the Setup programs and View options or to change the view or the sensor temperature.

SmartCal

To keep the sensor ready for use (i.e. calibrated for max. 12 hours).

Table view

To change to Trend table view.

Technical setup

To enter Auxiliary setup, Utilities, and Service mode.

Timer

To enter the Timer program.

Timer setup

To enter Timer setup.

Tutorial

To access instruction videos.

View options

To change the options in the Normal, the Trend table or the Trend curve view. Continued on next page

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