GE Marquette Solar SpO2 User manual

Solar® SpO2 Module

with Masimo SET

Service Manual

2004407-001 Revision A

127(Due to continuing product innovation, specifications in this manual are subject to change without notice.

Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained herein are the property of their respective owners.

900 SC, ACCUSKETCH, AccuVision, APEX, AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, C Qwik Connect, CardioServ, CardioSmart, CardioSys, CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, CORO, COROLAN, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, DASH, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE, INTELLIMOTION, IQA, LASER SXP, MAC, MAC-LAB, MACTRODE, MANAGED USE, MARQUETTE, MARQUETTE MAC, MARQUETTE MEDICAL SYSTEMS, MARQUETTE UNITY NETWORK, MARS, MAX, MEDITEL, MEI, MEI in the circle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 8000, MULTI-LINK, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, RAC RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNION STATION, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, and Vision Care Filter are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office.

12SL, 15SL, Access, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY Cumulus, Event-Link Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTER-LEAD, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, O

-LAN, CENTRALSCOPE, Corolation, EDIC, EK-Pro, Event-Link Cirrus, Event-Link

RESPONDER, MENTOR,

SENSOR, Octanet, OMRS, PHi-

Res, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, and Walkmom are trademarks of GE Medical Systems Information Technologies.

T-2 Masimo SET SpO2 Module Revision A

2004407-001 15 December 2000

Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Manual Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 -4

Definitions of Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Equipment Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

2 Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Solar SpO

Solar 7000 Patient Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Solar 8000 Patient Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Solar 8000M Patient Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Tram-rac Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Insert Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Module with Masimo SET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Revision A Solar SpO

2004407-001

with Masimo SET i

3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Recommended Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Recommended Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Inspection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Cleaning Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Exterior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Required Tools/ Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

SpO

Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Electrical Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

Required Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

Test Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

AC Hi-Pot Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Test Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Required Tools/Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Current Leakage Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Patient (Source) Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11

Patient (Sink) Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

Completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

PM Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Repair Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

ii Solar SpO

2004407-001

with Masimo SET Revision A

4 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

General Fault Isolation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

First Things to Ask . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Troubleshooting Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

System OK LED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

MS-3 Communications OK LED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Isolated Power Supply OK LED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Hardware Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Software Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

System Processor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Masimo MS-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Host Patient Monitor Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Power Condition and Soft Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Isolated Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Patient Connector Flex Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

External Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

SpO

Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

Probe Schematic Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Host Patient Monitor Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Software Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

5 Parts Lists and Drawings . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Ordering Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Field Replaceable Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Disassembly Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Assembly Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Masimo SET SpO Masimo SET SpO Masimo SET SpO

Reassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Solar SpO

Revision A Solar SpO

Module with Masimo SET 2001891-001A . . . . . . . . . . . . . . . . . . . . . . 5-5

2004407-001

MS-3 PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Module Flex PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 -4

Module PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

with Masimo SET iii

iv Solar SpO

2004407-001

with Masimo SET Revision A

1 Introduction

Revision A Solar SpO2 Module with Masimo SET 1-1

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For your notes

1-2 Solar SpO2 Module with Masimo SET Revision A

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Manual Information

Revision History

Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter changes whenever the document is updated.

Purpose

This manual provides technical information for maintaining the equipment. Use it as a guide for maintenance and electrical repair of parts considered field repairable.

Introduction: Manual Information

Revision Date Comment

A 15 December 2000 Initial release.

Intended Audience

Users of this manual are expected to have a background in electronics, including analog and digital circuitry with RF and microprocessor architectures. It is intended for service representatives and technical personnel who maintain, troubleshoot, or repair this equipment.

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Introduction: Safety Information

Safety Information

Responsibility of the Manufacturer

GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if:

assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies, Inc;

the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and

the device is used in accordance with the instructions for use.

Intended Use

This device is intended for use under the direct supervision of a licensed health care practitioner.

This device is not intended for home use. Federal law restricts this device to be sold by or on the order of a

physician. Contact GE Medical Systems Information Technologies for information

before connecting any devices to the equipment that are not recommended in this manual.

Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601 medical electrical systems standard.

Periodically, and whenever the integrity of the device is in doubt, test all functions.

The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:

use of the accessory in the PATIENT VICINITY; and

evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601 harmonized national standard.

If the installation of the equipment, in the USA, uses 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.

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Introduction: Safety Information

Definitions of Warnings, Cautions, and Notes

Warnings, cautions, and notes are used throughout this manual to designate a degree or level of hazardous situations. Hazard is defined as a source of potential injury to a person.

'$1*(5

indicates an imminent hazard which, if not avoided, will result in death or serious i njury.

:$51,1*

indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury.

&$87,21

indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage.

Equipment Symbols

127(provides application tips or other useful information to assure

that you get the most from your equipment.

The following symbols appear on the equipment.

ATTENTION: Consult accompanying documents before using the equipment.

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Service Information

Service Requirements

Introduction: Service Information

Refer equipment servicing to GE Medical Systems Information Technologies authoriz ed service personnel only.

Any unauthorized attempt to repair equipment under warranty voids that warranty.

It is the user’s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of their authorized agents.

Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.

Equipment Identification

Every GE Medical Systems Information Technologies device has a unique serial number for identification. The serial number appears on the product label on the base of each unit.

D 0 XX 0005 G XX

Month Manufactured

A = January B = February C = March D = April E = May F = June G = July H = August J = September K = October L = November M = December

Year Manufactured

0= 2000 1= 2001 2= 2002 (and so on)

Product Code

Two-character product descriptor

Product Sequence Number

Manufacturing number (of total units manufactured.)

Division

F = Cardiology G = Monitoring J = G.W. Labs

Device Characteristics

One or 2 letters that further describe the unit, for example: P = prototype not conforming to

marketing specification R = refurbished equipment S = special product documented

under Specials part numbers U = upgraded unit

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2 Equipment Overview

Revision A Solar S pO2 Module with Masimo S ET 2-1

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For your notes

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Equipment Overview: System Components

System Components

Solar SpO2 Module with Masimo SET

The Solar SpO2 module with Masimo SET, hereafter called the Masimo module, and accessories is intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO and pulse rate (measured by an SpO neonatal patients in hospitals and hospital-type environments. The Masimo module provides all the necessary patient isolation. The Masimo module is compatible with GE Medical Systems Information Technologies Solar 7000, 8000, and 8000M modular products including Tram-rac 4A. The device is housed in a standard single-high 7000 series module enclosure.

The Masimo module uses spectrophotometric analysis to determine the percent of oxygen saturation of hemoglobin in arterial bl ood also known as pulse oximetry. When inserted into a Tram-rac 4A housing connected to any Solar-based patient monitor, the module provides monitoring of peripheral oxygen saturation and pulse rate for an adult, pediatric, or neonatal patient.

sensor) for adult, pediatric, and

)

It uses Masimo LNOP cables. Other hardware functions include power conditioning (soft-start live-insertion capability, short-circuit protection) and isolation of the patient connected circuitry from earth ground.

Software may be updated using a laptop computer connected to any compatible Solar based patient monitor.

The Masimo module shown below monitors pulse oximetry.

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Equipment Overview: System Components

Solar 7000 Patient Monitor

One Solar based patient monitor used with the Masimo module is the Solar 7000 patient monitor (software version 3C, 4B, or later). It is an intelligent terminal, containing the display, all of the user controls, and processors to communicate with patient monitor peripherals and analyze patient data. It is capable of displaying up to six or eight different waveforms at one time. System software may be updated by a laptop computer at the monitor or through the Unity Network using a central station.

Solar 7000

Patient Monitor

Solar 8000 Patient Monitor

The Solar 8000 patient monitor system (software version 3C, 4B, or later) consists of a Solar 8000 processing unit with a compatible display. The processing unit provides the user controls, processors to communicate with patient monitor peripherals, and analyzes patient data. It is capable of displaying up to six or eight different waveforms at one time on the compatible 12, 15, 17, or 19-inch display. System software may be updated using a laptop computer conne cted to t he Solar 8000 processing unit or through the Unity Network using a central station.

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Equipment Overview: System Components

Solar 8000M Patient Monitor

The Solar 8000M patient monitor (software version 1A or later) consists of a Solar 8000M processing unit with compatible display.

The processing unit is the center of the Solar 8000M Patient Monitoring system. It provides the user con trols, t he processors t o communicate with various patient monitoring modules, and it analyzes patient data. It can display up to eight di fferent waveforms at one time. System software may be updated using a laptop computer connected to the Solar 8000M processing unit or from a central station on the Unity Network.

Tram-rac Housing

The Tram-rac housing (remote acquisition case) acquires patient data for the patient monitor. The Tram-rac Housing Service Manual has more information.

Only compatible Solar based monitors and the Tram-rac 4A (software version 6C or later) housing support the Masimo module.

Shown below is a Tram-rac 4A housing.

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Equipment Overview: Technical Specifications

Technical Specifi ca ti ons

127(

Nellcor, GE Medical Systems Information Technologies, and Masimo pulse oximetry is calibrated to display functional saturation. Ohmeda pulse oximetry is calibrated to display fractional saturation.

Item Description

Display Messages ARTIFACT DETECTED, LOW QUALITY, PROBE IS OFF

Measurement Range

Saturation Pulse Rate Perfusion

Performance Specifications

THE PATIENT, PROBE OR MODULE MALFUNCTION, POOR SIGNAL QUALITY DETECTED, PULSE SEARCH

1 to 100% SpO 25 to 240 bpm

0.02 to 20%

Accuracy

Saturation, no motion Saturation, motion

Pulse Rate, no motion Pulse Rate, motion

Item Description

Maximum Power Consumption

(non-isolated)

Item Description

Operating Conditions

Temperature Relative Humidity

SpO

over the range 70 to 100%, below 69% is unspecified

±2 digits for adults and pediatrics, ±3 digits for neonates SpO

over the range 70 to 100%, below 69% is unspecified

±3 digits for adults, pediatrics, and neonates 25 to 240 bpm, ±3 bpm

25 to 240 bpm, ±5 bpm

Power Requirements

+16.5V, 150mA +5V, 150mA

Environmental Specifications

0°C to 40°C (32°F to 104°F) 15 to 90% (non-condensing)

Storage Conditions

Temperature

Relative Humidity Altitude -305 to 1830m (-1000 to 6,000ft.) Atmospheric Pressure 645 to 795mmHg (860 to 1060hPa)

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–40°C to +70°C (–40°F to +140°F) 0 to 95% (non-condensing)

+ 40 hidden pages