Patient Data Module Service Manual sw ver 2 April 2014

NOTE Due to continuing product innovation, specifications in this manual are subject to change without notice. The information in this manual only supports Patient Data Module software version 2. It does not apply to earlier versions of software. Listed below are GE Medical Systems Information Technologies, Inc. trademarks used in this manual. All other trademarks contained herein are the property of their respective owners. UNITY NETWORK, DASH, SOLAR, TRAM, and TRIM KNOB are trademarks of GE Medical Systems Information Technologies, Inc. registered in the United States Patent and Trademark Office. CARESCAPE is a trademark of GE Medical Systems Information Technologies, Inc. For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies, Inc.

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Contents

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Introduction... 1-1 Manual information... 1-2 Revision history... 1-2 Manual purpose... 1-2 Intended audience... 1-2 Ordering manuals... 1-2 Illustrations and names... 1-2 Safety information... 1-2 Responsibility of the manufacturer... 1-2 Intended use... 1-3 Hazard definitions... 1-3 Patient Data Module hazards... 1-4 Safety symbols... 1-4 Equipment symbols... 1-5 Service information... 1-6 Service requirements... 1-6 Equipment Identification... 1-7

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Equipment Overview... 2-1 Overview... 2-2 Front view... 2-2 Rear view... 2-3 Side view... 2-3 Controls... 2-4 Indicators... 2-4 Connector... 2-4 Basic components... 2-5 Battery... 2-5 Patient Data Module ePort host interface cable... 2-5 Docking stations... 2-5 Theory of operation... 2-7 Overview... 2-7

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Installation... 3-1 Installation overview... 3-2 Inspection... 3-2 Battery... 3-3 Test the battery charge... 3-3 Install or change the battery... 3-3 Software... 3-4 Mounting options... 3-4 Mounting points to note... 3-6 Connect to host patient monitor... 3-8 Connect to transport bedside monitor... 3-8 Connect to bedside monitor... 3-9 PDM admit/discharge cycle... 3-10 PDM installation checkout procedure... 3-10 Electrical safety tests... 3-10 Battery check... 3-10 Functional checks... 3-11

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Service Tool and Configuration... 4-1 Overview... 4-2 Required equipment... 4-2 Set up the PC... 4-2 Connect the PC to the Patient Data Module... 4-2 Change the PC’s IP address... 4-4 Disable firewall and networking services... 4-5 Enter the Patient Data Module service tool... 4-6 Service tool modules... 4-7 Information... 4-7 Configuration... 4-8 Diagnostics... 4-10 Calibration... 4-10

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Maintenance... 5-1 Maintenance schedule... 5-2 Manufacturer recommendations... 5-2 Manufacturer responsibility... 5-2 Visual inspection... 5-2 Cleaning... 5-3 Precautions... 5-3 Permitted cleaning agents... 5-3 Cleaning procedures... 5-3 Storage... 5-4 Consequences of using improper cleaning product... 5-4 Cleaning products to avoid... 5-4 Expansion cover cleaning... 5-5 Battery compartment cleaning... 5-5 Sterilization... 5-6 Battery care... 5-6 Use recommendations... 5-7 Storage recommendations... 5-7 Charge the battery... 5-7 Condition the battery... 5-8 Checkout procedures... 5-9

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Troubleshooting... 6-1 Overview... 6-2 Required tools and equipment... 6-2 Before you begin... 6-2 Problems and solutions... 6-3 Error messages... 6-5

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Field Replaceable Units... 7-1 Ordering Parts... 7-2 Parts... 7-2

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Disassembly guidelines... 7-2 Tools required... 7-3 Before disassembly... 7-3 Hardware precautions... 7-3 Electrostatic discharge (ESD) precautions... 7-3 Replacement procedures... 7-4 Battery... 7-4 Labels... 7-6 Battery door and tray... 7-6 Pull tab and mount rail... 7-7 Top housing... 7-9 Main board... 7-11 NBP hose and coupling... 7-12 NBP assembly with manifold hose... 7-13 Main flex circuit assembly... 7-15 Recommended calibration and checkout tests... 7-18

A

Appendix A–Technical Specifications... A-1 Technical Specifications... A-2 Physical...A-2 Environmental...A-2 Battery...A-2 ECG...A-3 Respiration...A-5 Temperature...A-5 Invasive blood pressure...A-6 Non-invasive blood pressure...A-7 Pulse oximetry (SpO2)...A-9 Cardiac output...A-10 Certifications...A-10 Warranty...A-11

B

Appendix B– Electromagnetic Compatibility... B-1 Electromagnetic compatibility (EMC)... B-2 Guidance and manufacturer’s declaration – electromagnetic emissions... B-2

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Guidance and manufacturer’s declaration – electromagnetic immunity... B-3 Recommended separation distances... B-4 Compliant cables and accessories... B-5

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Introduction

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Manual information Revision history Each page of this manual has the document part number and revision letter at the bottom of the page. The revision letter identifies the document’s update level. The revision history of this document is summarized below. Revision

Comments

A

First published release of this document.

B

Updated FRU parts and battery recycling information.

Manual purpose This manual provides technical information for service representatives and technical personnel for maintaining the equipment.

Intended audience This manual is intended for service representatives and technical personnel who install, configure, maintain, administer, troubleshoot, or repair this equipment.

Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.

Illustrations and names This manual uses illustrations as examples only. Illustrations in this manual may not necessarily reflect all system settings, features, configurations or displayed data. Names of persons, institutions, and places and related information are fictitious; any similarity to actual persons, entities, or places is purely coincidental.

Safety information Responsibility of the manufacturer GE is responsible for the effects of safety, reliability, and performance only if:

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Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE.

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The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

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The equipment is used in accordance with the instructions for use.

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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 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 60601-1-1 harmonized national standard.

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

Hazard definitions Warnings and Cautions are used throughout this manual and designate a degree or level of hazardous situations. A hazard is defined as a source of potential injury to a person. DANGER DANGER- indicates an imminent hazard which, if not avoided, will result in death or serious injury.

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

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

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NOTE A NOTE provides application tips or other useful information.

Patient Data Module hazards WARNING ACCIDENTAL SPILLS-To avoid electric shock or device malfunction liquids must not be allowed to enter the device. If liquids have entered a device, take it out of service and have it checked by a service technician before it is used again.

Safety symbols

ATTENTION: Consult accompanying documents before using the equipment.

Defibrillator-proof type BF equipment; type BF equipment is specifically designed for applications intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment is type B equipment with an F-type isolated (floating) part. The paddles indicate the equipment is defibrillator proof. Defibrillator-proof type CF equipment; type CF equipment is specifically designed for applications where a conductive connection directly to the heart is established. The paddles indicate the equipment is defibrillator proof.

FDA Prescriptive Device symbol for: “Caution: Federal law restricts this device to sale by or on the order of a physician.”.

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Equipment symbols

Atmospheric pressure limitations.

Battery

Catalog or orderable part number.

Communication

ePort connection

European authorized representative.

European Union Declaration of Conformity

This symbol indicates the date of manufacture of this device. The first four digits identify the year and the last two digits identify the month.

2006-08

Humidity limitations.

Manufacturer name and address.

Power

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Temperature limitations.

Device serial number.

Medical Equipment With respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 NO. 601.1, IEC 60601-1, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, and IEC 60601-2-49.

4P41

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Zero all

Service information Service requirements

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Refer equipment servicing to GE’s authorized service personnel only.

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

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

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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.

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

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Equipment Identification Every GE Medical Systems Information Technologies, Inc. device has a unique serial number for identification. A sample of the information found on a serial number label is shown below.

### ## ## #### # #

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2

3

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Description 1

Product code1

2

Year manufactured

3

Fiscal week manufactured

4

Production sequence number

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Manufacturing site

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Miscellaneous characteristic

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Product code for the Patient Data Module is SA3.

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Equipment Overview

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Overview The Patient Data Module is a data acquisition device for a GE modular system. It provides a connection from the host monitor to the patient, processes the patient data signals and stores a limited amount of patient data (24 hours captured at 1 minute resolution) for seamless transport.

Front view

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3 404C

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Communication icon and indicator

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Power icon and indicator

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Power ON/IBP Zero All button

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Defib/Sync (for auxiliary equipment)

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Patient cable connectors

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Rear view

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ePort host interface connection

2

Battery door

Side view

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Pull tab

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Docking station

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Controls The power/zero all key has a dual role as a power on and zero all. 

Power on - Turns the data acquisition function ON. Power is derived from a battery or patient monitor. When turned on, the function changes to the zero all function.



Zero all - Zeros all invasive pressure lines which are open to atmosphere. Each pressure can also be zeroed, if desired, with a menu option in the pressure menu.

Indicators Communication The following LED condition identifies the communication status with a bedside or transport patient monitor. 

No light indicates no communication.

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Solid amber indicates an application reset.

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Solid green indicates communication.

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Flashing amber indicates communication failure.

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Alternately flashing with the power LED indicates software transfer.

Power The following LED condition identifies the power status. 

No light indicates no power applied.

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Solid amber indicates software booting up.

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Solid green indicates powered by AC-derived mains or battery.

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Flashing amber indicates approximately five minutes battery power remaining.

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Alternately flashing with the communication LED indicates software transfer.

Connector Patient Data Modules connect to a bedside or transport patient monitor using the host interface connector. It carries power, communication, and analog output signals to the display device.

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Basic components Battery The Patient Data Module is designed to operate on battery power when used with a transport monitor or whenever AC power is interrupted. A complete battery management system allows you to obtain maximum battery performance. When connected to a bedside monitor, audible and visual alarms alert you when loss of power is imminent, and on-screen capacity gauges on the transport monitor indicate battery charge condition and capacity.

Patient Data Module ePort host interface cable The Patient Data Module ePort host interface cable provides external power and communication between the Patient Data Module and a patient or transport monitor.

Docking stations There are three versions of docking stations: 

Bedside dock for use with Solar 8000M/i patient monitor.

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Transport dock for use with Transport Pro patient monitor.

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Fixed mount adapter (mini dock) for use with mounting hardware.

Patient Data Module bedside dock The Patient Data Module bedside dock is used for mounting the Patient Data Module to a bedside patient monitor. It has a host interface connection which delivers power, provides communication and allows easy connection with a patient monitor.

Patient Data Module transport dock The Patient Data Module transport dock is attached to a transport patient monitor when it ships from the factory. It is fastened to the back of the transport patient monitor and delivers power, provides communication and allows easy connection and disconnection.

Patient Data Module fixed mount adapter (mini dock) The Patient Data Module fixed mount adapter provides a mechanical connection between the Patient Data Module and mounting hardware. There are no electrical connections on the mini dock.

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