Operators Manual
169 Pages
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TCM4/40 operator’s manual
TCM4/40 operator’s manual
Table of contents
TCM4/40 monitoring systems
1.
Introduction
2.
What is what
3.
Menu structure and setup programs
4.
Installation and maintenance
5.
Calibration
6.
In vivo monitoring
7.
Troubleshooting
8.
Specifications and ordering information
9.
Functional description
10.
End user license agreements
Operator's manual
Index, password, and 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. © 2008 Radiometer Medical ApS. All rights reserved.
Contents Introduction
This manual describes how to operate the TCM4/40 systems and covers the following chapters and topics: 1.
Introduction... 1-1
Names, intended use, and limitations...1-2 Precautions and warnings...1-3 2.
What is what... 2-1
TCM4/40 monitors – top and front ...2-2 TCM4/40 monitors – rear...2-3 The screen: general elements ...2-4 Online tutorials...2-7 Touch key glossary ...2-8 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...3-9 Trend curve view...3-10 New patient ...3-14 Parameter setup ... 3-15
pCO2 ...3-16 pO2 ...3-18 SpO2/Pulse...3-20 Blood gas...3-22 Calibration setup... 3-24
SmartCal...3-25 Calibration status...3-26 Printer setup ... 3-27 Technical setup... 3-29
Technical settings...3-30 Date/time ...3-32 Service menu...3-33 Default values ...3-34
Contents
TCM4/40 operator's manual
4.
Installation and maintenance ... 4-1
Operating requirements...4-2 Installing the TCM4/40 systems ...4-3 Turning on and shutting down the TCM4/40 systems ...4-5 Cleaning the TCM4/40 systems ...4-6 Preparation and maintenance of the tcpO2/tcpCO2 electrodes ...4-7 Maintenance of the SpO2 sensor ...4-12 Maintenance of the TCM4/40 systems...4-14 5.
Calibration... 5-1
General information ...5-2 Calibration...5-3 Checking zero current and sensitivity ...5-5 6.
In vivo monitoring... 6-1
General information ...6-2 In vivo monitoring...6-6 Analog output...6-13 Serial data output: standard...6-15 Serial data output: VueLink ...6-18 Serial data output: data export...6-23 Trend table view...6-27 Trend curve view...6-29 Alarms...6-31 How to print ...6-35 In vivo calibration ...6-42 7.
Troubleshooting ... 7-1
The TCM4/40 systems ...7-2 8.
Specifications and ordering information... 8-1
Specifications ...8-2 Accessories...8-12 9.
Functional description ... 9-1
E5480 and E5280 electrodes ...9-2 pO2 measurement ...9-4 pCO2 measurement...9-5 Calibration of tcpO2/tcpCO2 electrode ...9-6 Solutions and calibration gases ...9-8 Traceability certificates...9-9 Pulse oximetry measurement ...9-12
TCM4/40 operator's manual
Contents
Calibration of SpO2 sensor...9-13 10. End user license agreements ... 10-1
End user license agreement for TCM4/40...10-2 End user license agreement for Microsoft Software ...10-3 Index Password Date of issue
Contents
TCM4/40 operator's manual
1. Introduction Overview Introduction
This chapter describes the intended use of the TCM4 and TCM40, respectively. It also contains the definitions of warnings, cautions and notes.
Contents
This chapter covers the following topics: Names, intended use, and limitations...
1-2
Precautions and warnings...
1-3
1. Introduction
TCM4/40 operator's manual
Names, intended use, and limitations Proprietary names
TCM4 and TCM40.
Common names Transcutaneous pO2/pCO2 monitoring system (TCM4) and Transcutaneous pO2/pCO2/SpO2/Pulse monitoring system (TCM40) TCM4 Series
The TCM4 and TCM40 monitoring systems are part of the TCM4 Series.
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 reserved
At the time of printing, the manual is in conformity with the systems. All rights are reserved for instruments, circuits, techniques, and names appearing in the manual.
Intended use
The TCM4 monitoring system is intended for continuous transcutaneous monitoring of oxygen (tcpO2) and carbon dioxide (tcpCO2) 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 oxygen (tcpO2) and carbon dioxide (tcpCO2) 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.
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/CAUTIONS: • The TCM4/40 monitoring systems are not blood gas devices. • tcpO2/tcpCO2 monitoring should not be used on patients in a compromised hemodynamic state. • The DS-100A SpO2 sensor is contraindicated for use on active patients or for prolonged use. It is not designed for long-term monitoring. • The OXI-A/N and OXI-P/I SpO2 sensors are contraindicated for use on patients who exhibit allergic reactions to the pressure-sensitive adhesive on the wraps. • In the USA, federal law restricts this device to sale, distribution, or use by or on the order of a physician.
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.
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TCM4/40 operator's manual
1. Introduction
Precautions and warnings Introduction
Throughout this manual, the various procedures may contain operational WARNINGS and/or CAUTIONS, which are important and should be read carefully before performing the related procedures. The manual also contains a number of NOTES.
Definitions
The following table indicates the type of information given in warnings, cautions, and notes: Type WARNING
Definition Alerts users to potentially serious outcomes to themselves or the patient such as • death • injury • serious adverse events
PRECAUTION
Alerts users to exercise the special care necessary for safe and effective use of the product: • Precautions may include actions to avoid situations that may not be potentially life-threatening or result in serious injury to patients or users, but of which the user should be aware. • Precautions may also alert the user to adverse effects on the product through use or misuse, and to the care required to avoid such effects.
NOTE
Gives practical information.
In this manual, a distinction between a warning and a caution is not made. An alerting notice is given the title WARNING/CAUTION.
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1. Introduction
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TCM4/40 operator's manual
2. What is what Overview Introduction
The TCM4 monitoring system includes: • TCM4 monitor • combined tcpO2/tcpCO2 electrode (E5480 or E5280) or tcpCO2 electrode (E5260) The TCM40 monitoring system includes: • TCM40 monitor • combined tcpO2/tcpCO2 electrode (E5480 or E5280) or tcpCO2 electrode (E5260) • SpO2 sensor (Nellcor OxiMax Durasensor DS-100A, Nellcor OxiMax Oxiband OXI-A/N, or Nellcor OxiMax Oxiband OXI-P/I) This chapter identifies the parts of the TCM4/40 monitors.
Contents
This chapter covers the following topics: TCM4/40 monitors – top and front ...
2-2
TCM4/40 monitors – rear...
2-3
The screen: general elements ...
2-4
Online tutorials...
2-7
Touch key glossary ...
2-8
2. What is what
TCM4/40 operator's manual
TCM4/40 monitors – top and front Front view
Touch screen
Handle
Calibration chamber
SpO2 module
Combi module Battery indicator
Monitor support and holder for electrode cable
button Monitor-elevating support
Parts and functions
The following table lists the parts located at the top and on the front of the TCM4/40 monitors, as well as their functions: Part Handle
For carrying the monitor.
Touch screen
For easy communication between operator and monitor.
Calibration chamber
For storage and calibration of tcpO2/tcpCO2 electrode.
Combi module
For transcutaneous measurements of tcpO2 and tcpCO2 and calibration of the electrode.
Monitor support and holder for electrode cable
For supporting the monitor and holding the electrode cable.
Monitor-elevating support
For supporting the monitor at an elevated angle.
button
Battery indicator SpO2 module
2-2
Function
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. NOTE: Only possible if the power switch on the back of the monitor is in the ON position. For measurements of SpO2 and pulse rate.
TCM4/40 operator's manual
2. What is what
TCM4/40 monitors – rear Rear view
tcpO2/tcpCO2 electrode socket
SpO2 sensor socket
Module release
Battery Ventilator
Line fuse Power switch Power socket
Ethernet (for authorized service personnel only)
Parts and functions
Serial port/ analog output
2 USB ports
The following table lists the parts located on the rear of the TCM4/40 monitors and their functions: Part Battery
Function For allowing monitoring during transport and power failure.
SpO2 sensor socket For connecting an SpO2 sensor to the monitor. Line fuse
1.25 AT. For preventing a short circuit. WARNING/CAUTION: Fire hazard. Replace fuse as marked.
Power socket
For connecting a power cord to the TCM4/40.
Serial port (RS232) For connecting the TCM4/40 to an external computer. USB ports
For connecting the TCM4/40 to an external printer. NOTE: It is only possible to use one of the ports at a time.
Analog output
For connecting the TCM4/40 to a peripheral device such as a polysomnograph.
Module release
For releasing the electrode module from the monitor with a release key.
tcpO2/tcpCO2 electrode socket
For connecting a tcpO2/tcpCO2 electrode to the monitor.
Power switch
For turning the power supply to the monitor ON and OFF. NOTE: If the power supply is ON, the battery will be recharged when needed.
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2. What is what
TCM4/40 operator's manual
The screen: general elements Screen types
There are two types of screens on the TCM4/40 monitors: view and menu screens.
View screen configuration
The view screens are divided into the following fields: Time/Date System/view status
Bat.
Curve display
pCO2/pO2 display
ID
pO2/pCO2 --------------------------------------------Power/SpO2
Pulse/SpO2 display
Touch keys
NOTE: SpO2 and pulse rate are available on the TCM40 only. On the TCM4, 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). The view screen contains the following information: Part
Shows
Time and date
The real time (24-hour cycle) and date
System/view status
Normal view, Trend table view, Trend curve view, New patient, Alert, or Alarm
Bat.
The battery level when the monitor is running on battery.
ID
Full , almost full , low and critically low Patient identification number
Curve display
pCO2, pO2, power (TCM4 only), and SpO2 (TCM40 only). Electrode/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 display
pCO2, pO2, Corr., Power, Temp, SmartHeat, In vivo calibration 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) (TCM40 only) Continued on next page
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TCM4/40 operator's manual
2. What is what
The screen: general elements, Continued Examples of view screen
The following is the main screen on the TCM40:
The following is the main screen on the TCM4:
NOTE: In Measuring mode, the Event touch key replaces the Tutorial touch key. View screen touch keys
The view screen (i.e. in Normal view) contains the following touch keys: Touch key
Function
Site time xx:xx
Resets the site timer to its preset value (see Parameter setup).
Tutorial
Gives access to instruction videos.
Event
Marks an event during monitoring.
Calibrate
Starts a calibration of the electrode (and the SmartCal period, if the function is set to ON in the setup).
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
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2. What is what
TCM4/40 operator's manual
The screen: general elements, Continued Menu screen configuration
The menu screens are divided into the following fields: 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 screen
The following is an example of a menu screen: Menu tabs
Settings Submenus
Touch keys NOTE: SpO2 is available on the TCM40 only. Menu screen touch keys
2-6
The menu screens contain the following touch keys: Touch key
Function
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.
TCM4/40 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. NOTE: In Measuring mode, the Event touch key replaces the Tutorial touch key.
NOTE: The DS-100A sensor tutorial can only be selected on the TCM40. 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
TCM4/40 operator's manual
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
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.
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. New patient
Gives access to the Patient ID screen.
Normal
Gives access to the Normal view setup.
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. Continued on next page
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