TCM 4, 40, 400 TOSCA and CombiM Service Manual Various Sw Versions Issue Jan 2013

TCM4 Series Service Manual

1. Introduction

1. Introduction Overview Introduction

This chapter gives an introduction to the servicing of the monitor together with important information for understanding the procedures and requirements.

Contents

This chapter contains the following topics.

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Disclaimer ...

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Five Basic Hardware Versions ...

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Service Policy ...

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Test Equipment and Tools ...

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1. Introduction

TCM4 Series Service Manual

Disclaimer 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 TCM4/40/400 and TCM TOSCA/CombiM monitoring systems comprise the Microsoft© Windows© CE 4.2 program or the Microsoft© Windows© CE 5.0 program. By using the system, you accept the terms of the Software License Agreement(s) of the providers 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 Radiometer makes no warranties, express or implied, other than expressly stated. Disclaimer 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. Continued on next page

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TCM4 Series Service Manual

1. Introduction

Disclaimer, Continued Yearly Verification

Based on the stability and lifetime specifications for certain components the items mentioned must be verified every 12 months to ensure proper system performance when the ages specified below are exceeded: Age

Part

≥ 10 years

Barometer on Main CPU PCB

≥ 15 years

Power Supply

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.

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1. Introduction

TCM4 Series Service Manual

Five Basic Hardware Versions Introduction

The TCM4 Series monitors exist in five different hardware configurations as detailed below and throughout the Service Manual. The introduction of new hardware versions originates both from introduction of new features and discontinuation of various hardware components. As will appear the differences involves both parts compatibility and procedures.

Original Version Concerns TCM400 monitors with serial numbers starting with: “000-152”. These monitors are configured as TCM400s measuring tcpO2 at 1 though 6 sites. 000-152

Second Version 000-154

Concerns TCM4 Series monitors with serial numbers starting with: “000-154”. These monitors may be configured via the software (and installation of optional modules) either as: Configuration

Parameters

No. of sensors

TCM400

tcpO2 at 1 though 6 sites

1-6

TCM4

tcpO2 and tcpCO2 at one site

1

In addition to the original version these monitors include an ON/OFF switch and a battery charge indicator on the front and they may operate on a battery backup during transportation and power breaks (option). Further the TCM4 is prepared (hardware) for connection to a hospital information system or computer via an Ethernet port.

Third Version 391-876

Concerns TCM4 Series monitors with serial numbers starting with: “391-876”. These monitors may be configured via the software (and installation of optional modules) either as: Configuration

Parameters

No. of sensors

TCM400

tcpO2 at 1 though 6 sites

1-6

TCM40

tcpO2 and tcpCO2 at one site, and

2

spO2 and pulse at a second site TCM4

Fourth Version 391-878

tcpO2 and tcpCO2 at one site

1

Concerns TCM4 Series monitors with serial numbers starting with: “391-878”. Basically these monitors may be configured in the same way as for the “Third Version” above. This hardware version is equipped with a USB interface for connection of printers. Continued on next page

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TCM4 Series Service Manual

1. Introduction

Five Basic Hardware Versions, Continued Fifth Version 391-880

Concerns TCM4 Series monitors with serial numbers starting with: “391-880”. These monitors may be configured via the software (and installation of optional modules) either as: Configuration

Parameters

No. of sensors

TCM400

tcpO2 at 1 though 6 sites

1-6

TCM40

tcpO2 and tcpCO2 at one site, and

2

spO2 and pulse at a second site TCM4

tcpO2 and tcpCO2 at one site

1

TCM CombiM

tcpO2 and tcpCO2 at one site

1

TCM TOSCA

tcpCO2, spO2, and pulse at one site

1

This hardware version is equipped with a more powerful PC, a new 20-pole connector for serial communication and analog output and USB2.0 ports.

Compatibility

Most electronics are different in the five hardware versions. Most PCBs used in each of the four versions are not compatible with the ones used in the other versions. This is due to changes in the electrical interfaces between the various PCBs. For details, please refer to the chapter “Spare Parts”.

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1. Introduction

TCM4 Series Service Manual

Service Policy Introduction

This section outlines the policies and procedures, which must be followed when servicing TCM4 Series monitors. The service policy has been outlined to obtain a maximum degree of reliability and a minimum of repair time. This is obtained by demanding that the advanced and time-consuming troubleshooting, repair, and testing is carried out at the factory. Further, a combination of troubleshooting procedures in the Service Manual, and a high degree of modulization facilitate quick localization of faults in the monitor. By using the test equipment, procedures and spare parts listed in this Service Manual the continued reliability of the product is ensured. Exceptions from the service policy are not allowed unless Radiometer Medical ApS beforehand has given special permission or instructions in writing.

Non-Original Parts

Spare Parts and Accessories in General In order to ensure the reliability, durability, patient safety, and operation in accordance with technical specifications only original Radiometer Medical ApS parts, or parts approved by Radiometer Medical ApS must be used. This concerns both spare parts and accessories.

Electrostatic Discharge Protection

In order to ensure the reliability and durability of the monitor, ESD protection precautions must always be taken when handling or exposing ESD sensitive parts. Parts such as printed circuit boards may be damaged if handled incorrectly during storage and service. The damage is not visible, and the damaged parts may not fail immediately but several months later.

Repair Level

The repair level outlines the extent to which it is allowed to dismantle a monitor in the process of troubleshooting and repair. This level is limited for several reasons such as: the need for specialized test equipment, special environmental requirements, patient safety etc., and is optimized in relation to cost of parts, time of repair etc. The repair level is indicated in the sections “Dismantling and Replacements” and "Spare Parts List". Continued on next page

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TCM4 Series Service Manual

1. Introduction

Service Policy, Continued Repair Level (continued)

Electronics Repair of the electronics is not allowed in the field. The reason for this is that most of the electronics are based on the surface mounted technology (SMT) which involves a high component density and thereby a high complexity. Repair of this kind of printed circuit boards (PCB) requires advanced troubleshooting, repair and test facilities, which are only available at the factory. Larger PCBs are defined as modules which may be returned to the factory for replacement under the trade-in arrangement for modules - these PCBs are marked with “*” next to the description in the spare parts list. As repair of electronics is not allowed in the field, detailed circuit diagrams are not included in the Service Manual.

Manipulation of Manipulation of the contents of the Compact FLASH card must only be carried out using the tools provided by RADIOMETER specifically intended for the TCM4 CF Card Series. That is, the features incorporated in the monitor’s application software and the FTP server used for software upgrade. The only exceptions from the above policy are procedures for specific areas published by RADIOMETER e.g. in the Service Manual itself or as a Service Tip. RADIOMETER cannot guarantee the monitor’s performance and data integrity in case unauthorized manipulations have been performed.

Software

Only original software specifically intended for the TCM4 Series and made available through RADIOMETER must be installed on the monitor.

USB Devices

In order to protect the monitor from virus infection, all external media must be scanned for virus contents, using an updated virus-scanning program before connecting them to the monitor. A USB FLASH memory must be scanned on a personal computer before it is connected to the USB connector on the monitor.

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1. Introduction

TCM4 Series Service Manual

Test Equipment and Tools Introduction

To carry out the procedures for servicing the monitor a number of test equipment, tools, and software media are required.

Tools

The following test equipment and tools are required for servicing the monitor: Parts marked with “N/A” in the “Part #” column are to be purchased locally. Part #

Description

Purpose

901-705

TC-Electrode Simulator

Check of Electrode Module

617-854

Electrode Test Cable

Check of Electrode Module

920-743

SpO2 Module Tester

Check of SpO2 Module

617-945

Sensor cable for 920-743

Check of SpO2 Module

886-479

Module release tool

For releasing the optional modules

N/A

Screwdriver, 3.0 mm Pozidrive

Various

N/A

Screwdriver, 4.0 mm Pozidrive

Various

N/A

5 mm box wrench

Various

N/A

2 mm Umbraco

Various

N/A

2.5 mm Umbraco

Various

N/A

PS/2 alphanumerical keyboard

Facilitates software upgrade of Electrode Module and setup of BIOS

N/A

Personal Computer

Facilitates software upgrade of Electrode Module and Main CPU PCB (391-876 onwards)

636-473

Programming adapter, cables, and software

Facilitates software upgrade of Electrode Module

N/A

Crossed Ethernet cable (patch)

Software upgrade of Main CPU PCB (391-876 onwards)

902-028

Loop-back Plug

Check of the COM port

847-398

CAL2 Gas Adaptor

Second point calibration of CO2 (TCM4/40 only) Continued on next page

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TCM4 Series Service Manual

1. Introduction

Test Equipment and Tools, Continued Software Media The following table lists the software media available for the monitors: Part #

Description

Software for

TCM Monitor

914-472

Compact Flash Card with program, V2.10, English

Main CPU PCB

000-152: TCM400

914-480

Compact Flash Card with program, V2.10, German

Main CPU PCB

000-152: TCM400

914-473

Compact Flash Card with program, V2.10, French

Main CPU PCB

000-152: TCM400

914-476

Compact Flash Card with program, V2.10, Italian

Main CPU PCB

000-152: TCM400

914-478

Compact Flash Card with program, V2.10, Spanish

Main CPU PCB

000-152: TCM400

914-477

Compact Flash Card with program, V2.10, Portugese

Main CPU PCB

000-152: TCM400

914-471

Compact Flash Card with program, V2.10, Danish

Main CPU PCB

000-152: TCM400

914-479

Compact Flash Card with program, V2.10, Swedish

Main CPU PCB

000-152: TCM400

914-475

Compact Flash Card with program, V2.10, Dutch

Main CPU PCB

000-152: TCM400

914-474

Compact Flash Card with program, V2.10, Greek

Main CPU PCB

000-152: TCM400

914-674

Compact Flash Card with program, TCM4 V1.12, TCM400 V2.13. All implemented languages included

Main CPU PCB

000-154: TCM4 + TCM400

Continued on next page

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1. Introduction

TCM4 Series Service Manual

Test Equipment and Tools, Continued Software Media (continued)

Part #

Description

Software for

TCM Monitor

914-697

CD-ROM with program, TCM4/40 V2.13 and TCM400 V3.01. All languages

Main CPU PCB

391-876: TCM400

914-698

Compact Flash Card with program, TCM4/40 V2.13 and TCM400 V3.01. All languages

Main CPU PCB

391-876: TCM400

914-967

CD-ROM with program, TCM4/40 V2.14.5 and TCM400 V4.01. All languages

Main CPU PCB

391-878: All configurations 1)

914-968

Compact Flash Card with program, TCM4/40 V2.14.5 and TCM400 V4.01. All languages

Main CPU PCB

391-878: All configurations 1)

933-116

Compact Flash Card with program, TCM400 V4.21 All other V3.02. All languages

Main CPU PCB

391-880: All configurations 2)

933-210

CD-ROM with program, TCM400 V4.22 All other V3.04. All languages

Main CPU PCB

391-880: All configurations

933-209

Compact Flash Card with program, TCM400 V4.22 All other V3.04. All languages

Main CPU PCB

391-880: All configurations 3)

Continued on next page

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TCM4 Series Service Manual

1. Introduction

Test Equipment and Tools, Continued Software Media (continued)

Part #

Description

Software for

TCM Monitor

933-126

CD-ROM with Electrode Electrode Module Module software V00.01.12 (tcpO2)

All HW versions: TCM400

914-619

CD-ROM with Combi Combi Module Module software V00.01.01 (tcpCO2 + tcpO2)

000-154: TCM4

902-778 R01-R82 914-855

CD-ROM with Combi Combi Module Module software V00.01.04 (tcpCO2 + tcpO2) 902-778 R83 onwards

391-876 onwards: TCM4 + TCM40 000-154: TCM4 391-876 onwards: TCM4 + TCM40

914-659

CD-ROM with the TCM_FTP program, V1.02

Software upgrade of Main CPU

Basic Units: 391-876 / 391-878

933-110

CD-ROM with the TCM_FTP program, V1.05

Software upgrade of Main CPU

Basic Unit: 391-880

1) May also be used with 391-876 monitors. However, for TCM400 this upgrade requires a new Operators’ Manual to reflect the new facilities. 2) Must be used for 391-880 below R095 only (produced with BIOS V1.0). 3) Must be used for 391-880R095 onwards (produced with BIOS V1.1) and for monitors below R095 if updated to BIOS V1.1 only.

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1. Introduction

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TCM4 Series Service Manual

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TCM4 Series Service Manual

2. Troubleshooting

2. Troubleshooting Overview Introduction

This chapter provides the various error indications and suggestions for troubleshooting the system and remedy the error. This chapter has been divided into two sections, one for TCM400 and one for TCM4/TCM40.

Contents

This chapter contains the following topics. TCM400 ...

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TCM4/TCM40 ... 2-13 TCM TOSCA/CombiM ... 2-25

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2. Troubleshooting

TCM4 Series Service Manual

TCM400 Overview Introduction

This section provides the various error indications and suggestions for troubleshooting the TCM400 and remedy the error.

Two Versions

Basically the software for the TCM400 of the five different hardware versions of the Basic Unit, 000-152, 000-154, 391-876, 391-878, and 391-880 is identical. Therefore, also the various messages are identical. However, for TCM400 of hardware versions 000-154 onwards, which may include a battery, there are a few additional messages relating to the condition of the battery. It is clearly indicated in the tables on the following pages which messages are not applicable for 000-152. Further, for software version V4.00 onwards the way data are handled internally has been changed. This adds a number of new messages to the troubleshooting.

Contents

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This section contains the following topics. Symptoms with no Message...

2-3

Operational and Status Messages ...

2-5

Computer and Dialog Box Messages ...

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TCM4 Series Service Manual

2. Troubleshooting

Symptoms with no Message Introduction

This paragraph lists various symptoms, which do not result in a message on the TCM400. For each symptom an interpretation together with user and service actions for remedying the symptom are given.

Symptoms

The table below lists the symptoms that may appear together with interpretation and corrective actions. Symptom Measured values drift when electrode is measuring on cal gas (in vitro) or air

Interpretation

User Action

Service Action

Insufficient removal of Remembrane the None electrode old electrolyte during membraning procedure Check electrode zero current and Bubbles in electrode sensitivity The electrode membrane has not been regularly changed Defective electrode membrane (holes or scratches) Defective O-rings (one or both O-rings broken)

Measured values drift constantly without any physiological cause when electrode mounted on patient (in vivo)

None Improper attachment of Detach the the electrode electrode and reapply correctly Improper attachment of the fixation ring Detach the fixation ring and An inappropriate reapply correctly measurement site has been selected Inadequate vasodilation

Measured values not stable or out of limits 20 minutes after application

Patient status unstable Inadequate vasodilation

Evaluate patient status

None

Remount the Improper attachment of electrode the electrode Continued on next page

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2. Troubleshooting

TCM4 Series Service Manual

Symptoms with no Message, Continued Symptoms (continued)

Symptom

Interpretation

Measured values change suddenly without any physiological cause

Artifact due to patient movements Air leakage under fixation ring Self-adhessive ring does not stick to the skin

User Action

Service Action

Recalibrate and None reapply electrode to the skin, possibly selecting a new measuring site

Noise appears on Interference by nearby the tension equipment readout

None Increase the distance from the interfering equipment

Monitor not operational

Check the connection

Check mains supply

Contact your Radiometer service technician

Check/replace the battery

Monitor defective Battery is exhausted (Not applicable for 000-152) Monitor not connected to mains

Check/replace Power Supply Replace Main CPU PCB

2-4

Battery Low (battery bar and “High”and “Low” are flashing)

Battery level is low (Not applicable for 000-152)

Connect the monitor to the mains

None

Battery Low (battery bar and “High”and “Low” are flashing and a continuous alert sound is heard)

Battery level is critically low (Not applicable for 000-152)

Connect the monitor to the mains immediately

None

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TCM4 Series Service Manual

2. Troubleshooting

Operational and Status Messages Introduction

This paragraph lists all available error messages relating to the operation and status of the TCM400. For each message an interpretation together with user and service actions for remedying the errors are given.

Procedures

The table below lists the error messages that may appear together with interpretation and corrective actions. Message

Interpretation

Cal error Barometer

Barometer value invalid when collected at start of calibration

Cal error – Chamber

Cal error Drift

User Action Start a new calibration

Service Action Replace Main CPU PCB

If error reappears, contact your Radiometer service technician

Place a tcpO2 No electrode detected in the electrode in the calibration chamber chamber at start of or during calibration

Check Electrode Module

The electrode is rejected during the drift check

None

Start a new calibration

Replace if necessary

If the error reappears, remembrane the electrode, and start a new calibration If error still reappearsthe electrode is defective. Replace with a new one Continued on next page

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2. Troubleshooting

TCM4 Series Service Manual

Operational and Status Messages, Continued Procedures (continued)

Message Cal error Sensitivity

Interpretation The electrode sensitivity is outside the specifications

User Action If the electrode has just been remembraned, start a new calibration. Otherwise remembrane the electrode and start a new calibration

Service Action Check Electrode Module Replace if necessary

If the error reappears, the electrode is defective. Replace with a new one The selected electrode temperature cannot be reached (within three minutes after starting the calibration)

Calibrate the electrode

Check Electrode Module

If the error reappears, the electrode is defective. Replace with a new one

Replace if necessary

Calibration recommended (Below V4.00 only)

Four hours have passed since the last successful calibration

Continue monitoring, but be aware of the possible drift of the electrode, or perform a calibration

None.

Calibration required

The last calibration has been aborted

Perform a calibration

None

Cal error Temperature

Eight hours have passed since the last successful calibration Continued on next page

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TCM4 Series Service Manual

2. Troubleshooting

Operational and Status Messages, Continued Procedures (continued)

Message Heater Failure

Interpretation The electrode has been subject to excessive heating (power >500mW over >2 minutes) The measured power is out of the measuring range

Module Disappeared

No Electrode Connected

For unknown reasons, the communication between the monitor and the module has not been satisfactory

User Action Calibrate the electrode

Replace the Electrode Module

If the error reappears, the electrode is defective. Replace with a new one Turn the monitor off and on

Check Interface PCB

If the error reappears, try with another module

Check Main CPU PCB

If the error reappears on the new module, contact your Radiometer service technician

Connect a No electrode is functional tcpO2 detected in the calibration chamber electrode The electrode in the calibration chamber is not functioning

Out Of Range The measured pO2 value is outside the measuring range

Service Action

Replace the electrode on the patient

Replace, if necessary

Replace the electrode Replace the Electrode Module

Replace the Electrode Module

Recalibrate the electrode Continued on next page

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