GE Medical Systems PRO 100, PRO 200, PRO 300, PRO 400 Blood Pressure Monitor Service Manual

PRO Series 100 - 400 V2

Service Manual

(Models 110 - 410)

DINAMAP

®

PRO Series 100-400V2

Monitor Service Manual

NOTE

The Model Numbers 100 through 400 are generic in nature and reflect the range of product codes available. Your product may be labeled with a specific product code such as DINAMAP

®

PRO Model 410.

“V2” refers to the second version of the product’s design

.

2018553-001 Revision B

DINAMAP® PRO Series 100-400V2 Monitor Service Manual

2018553-001

Revision B

Revision B

DINAMAP

®

Series PRO 100-400V2 Monitor

Service Manual

This manual is for DINAMAP PRO Series Monitor models 100, 200, 300, and 400, with or without printers.

• PRO 100: BP, Pulse

• PRO 200: BP, Pulse, and Temp

• PRO 300: BP, Pulse, and SpO

2

• PRO 400: BP, Pulse, Temp, and SpO

2

The model of the Monitor determines which parameters are in your monitor.

Please refer to applicable sections.

Reissues and Updates

Changes occurring between issues are addressed through Change

Information Sheets, Addendums, and replacement pages. If a Change

Information Sheet does not accompany this manual, it is correct as printed.

Errors and Omissions

If errors or omissions are found in this manual, please notify:

GE Medical Systems Information Technologies, Inc.

8200 West Tower Avenue

Milwaukee, WI 53223 USA

Tel: +414.355.5000

800.558.5120 (US only)

Fax:+414.355.3790

Part No. 2018553-001 B

The content of this document including all figures and drawings is proprietary information of GE Medical Systems Information Technologies, provided solely for purposes of operation, maintenance or repair, and dissemination for other purposes or copying thereof is prohibited without prior written consent by GE Medical Systems Information Technologies.

Illustrations may show design models; production units may incorporate changes.

Hierarchy of Warnings and Cautions

A general warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the misuse of the device. A warning relates to steps in a procedure.

A general caution is a statement that alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, damage to the device or damage to other property. A caution relates to steps in a procedure.

© Copyright 2004, GE Medical Systems Information Technologies. All rights reserved.


2018553-001

World Headquarters

GE Medical Systems Information Technologies, Inc.



Tel: +414.355.5000

800.558.5120 (US only)

Fax:+414.355.3790

European Representative

GE Medical Systems

Information Technologies GmbH

Munzinger Straße 3-5

D-79111 Freiburg

Germany

Tel: + 49 761 45 43 - 0

Fax: + 49 761 45 43 - 233

Asia Headquarters

GE Medical Systems

Information Technologies Asia; GE (China) Co., Ltd.

24th Floor, Shanghai MAXDO Center,

8 Xing Yi Road, Hong Qiao Development Zone

Shanghai 200336, P.R. China

Tel: + 86 21 5257 4650

Fax: + 86 21 5208 2008


2018553-001

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Table of Contents

TABLE OF CONTENTS

Section 1. INTRODUCTION

1.1 SCOPE OF MANUAL ......................................................................... 1-3

1.2 ADDENDA .......................................................................................... 1-4

1.3 TRADEMARKS AND TRADE NAMES ............................................... 1-4

1.4 SERVICE POLICY .............................................................................. 1-4

1.5 EXTENDED WARRANTIES ............................................................... 1-4

1.6 ASSISTANCE ..................................................................................... 1-4

1.7 SERVICE ............................................................................................ 1-5

1.7.1 Packing Instructions ............................................................. 1-5

1.7.2 Insurance ............................................................................. 1-5

1.7.3 Replacement Assemblies and Components ........................ 1-5

1.7.4 Replacement Accessories ................................................... 1-6

1.8 INSTALLATION AND OPERATION ................................................... 1-6

1.9 WARNINGS AND PRECAUTIONS .................................................... 1-6

1.10 DISPOSAL OF PRODUCT WASTE ................................................. 1-6

1.10.1 Batteries ............................................................................. 1-6

1.10.2 Patient Applied Parts ......................................................... 1-7

1.10.3 Packaging Material ............................................................ 1-7

1.10.4 Monitor ............................................................................... 1-7

1.11 SYMBOL DEFINITIONS ................................................................... 1-8

1.12 GLOSSARY OF TERMS AND ABBREVIATIONS ............................ 1-9

Section 2. PRODUCT DESCRIPTION

2.1 INTRODUCTION ................................................................................ 2-3

2.2 PRODUCT CONFIGURATIONS ........................................................ 2-3

2.3 CONTROLS, INDICATORS, AND CONNECTORS ........................... 2-3

3.1 PRO Series Monitor Rear Panel Connections ........................ 2-4

2.3.2 Front Panel Controls and Indicators .................................... 2-5

2.4 HOST PORT CONNECTOR (REAR PANEL) .................................... 2-7

2.5 REORDER PART NUMBERS ............................................................ 2-8

2.6 SPECIFICATIONS ............................................................................ 2-10

Revision B DINAMAP® PRO Series 100-400V2 Monitor Service Manual

2018553-001

Table of Contents

Section 3. THEORY OF OPERATION

3.1 INTRODUCTION ................................................................................ 3-3

3.2 OVERALL PRINCIPLES OF OPERATION ........................................ 3-3

3.2.1 Cuff Blood Pressure (BP) and Pulse ................................... 3-3

3.2.2 Temperature (Model 200 and 400) ...................................... 3-4

3.2.3 SpO2 (Model 300 and 400) ................................................. 3-4

3.2.4 Host Communication Port .................................................... 3-4

3.3 FUNCTIONAL DESCRIPTION ........................................................... 3-5

3.3.1 PSU PWA ............................................................................ 3-5

3.3.2 PSU Module ......................................................................... 3-5

3.3.3 Main Board .......................................................................... 3-5

3.3.4 SpO2 PWA (Optional) .......................................................... 3-6

3.3.5 Pneumatic Control Device ................................................... 3-7

3.3.6 LCD Assembly ..................................................................... 3-7

3.3.7 Printer PWA w/Printer .......................................................... 3-7

Section 4. GENERAL MAINTENANCE

4.1 INTRODUCTION ................................................................................ 4-3

4.2 FUSES ................................................................................................ 4-3

4.3 PERIODIC MAINTENANCE ............................................................... 4-3

4.3.1 Cleaning the Monitor ............................................................ 4-3

4.3.2 Power-Up Checks ................................................................ 4-4

4.3.3 External DC Supply and Battery .......................................... 4-5

4.3.4 Care of the Storage Battery ................................................. 4-5

4.3.5 Checking Calibration ............................................................ 4-6

4.4 CLINICIAN MODE ............................................................................... 4-6

4.4.1 Accessing the Clinician Mode .............................................. 4-6

4.4.2 Clinician Mode Main Menu .................................................. 4-7

4.4.3 Clinician More... Menu ......................................................... 4-8

4.5 SERVICE MODE .............................................................................. 4-10

4.5.1 Accessing the Service Mode ............................................. 4-10

4.5.2 Service Mode Main Menu .................................................. 4-11

4.5.3 NIBP Menu ........................................................................ 4-12

4.5.4 System Menu ..................................................................... 4-14


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4.6 PRE-SERVICE TEST PROCEDURES ............................................. 4-16

4.6.1 SpO2 Checks (PRO 300 & 400) ........................................ 4-16

4.6.2 Leak Test ........................................................................... 4-18

4.6.3 NIBP Calibration Check ..................................................... 4-19

4.6.4 Neonate Overpressure Check ........................................... 4-20

4.6.5 Adult Overpressure Check ................................................. 4-20

4.6.6 Temperature System Check (PRO 200 & 400) ................. 4-21

4.6.7 Printer Test ........................................................................ 4-22

4.7 PRO MONITOR CALIBRATION PROCEDURES ............................ 4-22

4.7.1 Calibrating the NIBP Transducer ....................................... 4-22

4.7.2 Overpressure Adjustment of a Two-Pot System ................ 4-23

4.8 ELECTRICAL SYSTEM SAFETY CHECKS ..................................... 4-25

4.9 FEATURES SELECTION .................................................................. 4-25

4.10 TROUBLESHOOTING .................................................................... 4-27

4.11 ERROR CODES.............................................................................. 4-29

Appendix A: Test Records

Appendix B: Field Replaceable Parts and Assembly

Drawings

Appendix C: Electromagnetic Compatibility


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Table of Contents


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1

Introduction


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1-1

1-2 DINAMAP® PRO Series 100-400V2 Monitor Service Manual

2018553-001

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Introduction

Section 1. INTRODUCTION

1.1 SCOPE OF MANUAL

This service manual provides service, parts, and repair information and functional descriptions for the DINAMAP ® PRO Series Monitors,

Models 100, 200, 300, and 400. The model number identifies the vital signs monitoring capabilities built into the unit.

PRO 100: BP, pulse

PRO 200: BP, pulse, temperature

PRO 300: BP, pulse, SpO

2

PRO 400: BP, pulse, temperature, SpO

2

This manual is intended for use by biomedical engineers and trained service technicians who are familiar with electromechanical devices and digital and analog circuit techniques.

WARNINGS:

 To reduce the risk of electric shock, do not open the case. No user-serviceable parts are inside the case. Refer servicing to qualified service personnel.

Trained service technicians should perform all unit repairs.

Voltages dangerous to life exist in this unit. Take care when servicing power supply and display assembly.

For information about operating PRO Series Monitors in a clinical environment, refer to the separate operation manual.

This service manual is composed of the following five sections:

Section 1 describes this manual and tells you how to use it. Information is also provided about how to get assistance if the unit fails to function properly.

Section 2 provides the physical and functional characteristics of the

PRO Series Monitor.

Section 3 explains the principles of operation for the PRO Series

Monitor, including an overall system description and principles of operation at the PWA (printed wiring board) level.

Section 4 provides information about periodic and corrective maintenance of the PRO Series Monitor. Procedures include calibration checks, recalibration, performance tests, and fault isolation.

Section 5 provides component information about the PRO Series

Monitor, including disassembly procedures, parts lists, assembly diagrams, and electrical schematics.


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Introduction

1.2 ADDENDA

When this manual was published it included the most up-to-date information and procedures available. However, the specifications, design, assembly, or software controls may change. These changes are incorporated into this manual by addenda.

1.3 TRADEMARKS AND TRADE NAMES

This document references terms that are proprietary, and may be registered and protected by copyrights and other applicable laws and agreements.

The first time trademarks and trade names are used in a section of this document, they are followed by “*” or “**”. A footnote will identify the owner of the trademark or trade name.

1.4 SERVICE POLICY

1.5 EXTENDED WARRANTIES

Extended warranties may be purchased on most products. Contact your Sales Representative for details and pricing.

1.6 ASSISTANCE

The warranty for this product is enclosed with the product in the shipper carton. All repairs on products under warranty must be performed or approved by Customer Support personnel.

Unauthorized repairs will void the warranty. Products not covered by warranty should be repaired by qualified electronics service personnel.

If the product fails to function properly or if assistance, service, or spare parts are required, contact Customer Support. Before contacting Customer Support, it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the problem. If you are unable to resolve the problem after checking these items, contact Customer Support. When you call, please be prepared to provide:

Product name and model number

A complete description of the problem

1-4

If repair parts or service are necessary, you will also be asked to provide:

The product serial number

The facility's complete name and address


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Introduction

A purchase order number if the product is to be sent for repairs or you order spare parts

The facility's GE Medical Systems Information Technologies account number, if possible

The part number for replacement assemblies or parts

1.7 SERVICE

If your product requires repair service, call Customer Support and a representative will assist you. Prior to returning any product for repair, you must request a Return Authorization number. Call GE Medical

Systems Information Technologies at: 1-877-274-8456 Monday through Friday, 8:00 a.m. to 6:00 p.m. EST, excluding holidays.

1.7.1 Packing Instructions

Follow these recommended packing instructions.

Remove the battery and all hoses, cables, sensors, and power cords from the PRO Series Monitor before packing.

Pack only the accessories you are requested to return. Place them in a separate bag and insert the bag and the product inside the shipping carton.

Use the original shipping carton and packing materials, if available.

If the original shipping carton is not available, place the product in a plastic bag and tie or tape the bag to prevent loose particles or materials from entering openings such as the hose ports.

Use a sturdy corrugated container to ship the product; tape securely to seal the container for shipping.

Pack with 4 in. to 6 in. of padding on all sides of the product.

1.7.2 Insurance

Insurance is at the customer's discretion. Claims for damage to the product must be directed to the shipper.

1.7.3 Replacement Assemblies and Components

Assemblies and components can be ordered from GE Medical

Systems Information Technologies:

Via phone: 1-800-558-7044, Option #2

Via FAX: 1-800-232-2599

Information is also available on the World Wide Web at: http://www.gemedical.com


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Introduction

All orders must include the following information:

Facility's complete name, address, and phone number

FAX number

Your purchase order number

Your GE Medical Systems Information Technologies account number

Please allow one working day for confirmation of your order.

1.7.4 Replacement Accessories

Replacements such as hoses, sensors, etc. must be purchased from

GE Medical Systems Information Technologies at 1-800-558-5102

(fax 1-800-232-2599). Please have the Reorder/Product Code or part number of the item you wish to order, and your purchase order and account number available.

1.8 INSTALLATION AND OPERATION

For information on the installation and operation of the PRO Series

Monitor, refer to the separate operation manual. The PRO Series

Monitor should be operated and serviced by authorized personnel, and only in accordance with the warnings and precautions given in both the operation manual and this service manual.

1.9 WARNINGS AND PRECAUTIONS

Refer to the operating safety warnings and precautions detailed in the separate operation manual.

1.10 DISPOSAL OF PRODUCT WASTE

As you use the PRO Monitor, you will accumulate solid wastes that require proper disposal or recycling. These include batteries, patient applied parts, and packaging material.

1.10.1 Batteries

Caution: Do not incinerate batteries.

The sealed, rechargeable backup battery contains lead and can be recycled. The rechargeable memory battery is of the Nickel Metal

Hydride form. Discharge this battery prior to disposal. Place the battery in packaging which electrically isolates its contents. Do not puncture or place the battery in a trash compactor. Do not incinerate the battery or expose it to fire or high temperatures. Dispose in accordance with regional body controlled guideline.


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Introduction

1.10.2 Patient Applied Parts

Certain patient applied parts, such as those with adhesive

(disposable SpO

2

sensors), are intended for single use and should be disposed of properly as medical waste in accordance with regional body controlled guideline.

Other patient applied parts, such as blood pressure cuffs, should be cleaned according to instructions. Inspect reusable applied parts for wear, replace as necessary, and dispose of used product as medical waste in accordance with regional body controlled guideline.

1.10.3 Packaging Material

Retain original packaging materials for future use in storing or shipping the Monitor and accessories. This recommendation includes corrugated shippers and inserts.

Whenever possible recycle the packaging of accessories and patient applied parts.

1.10.4 Monitor

At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of the product, please contact GE

Medical Systems Information Technologies or its representatives.


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1-7

Introduction

1.11 SYMBOL DEFINITIONS

BPM

Attention: consult accompanying documents

Power ON/OFF

SILENCE

START/STOP BP

AUTO BP

Mean Arterial Pressure (MAP)

External Communications Port Connector

Defibrillator-proof Type B.F. equipment

SpO

2

Temperature

Beats Per Minute (BPM)

Battery Power

External AC or DC Power Indicator

External DC Power Input

External AC Power Input

SpO2 Motion Artifact (US)

SpO2 Motion Artifact (Europe)

Packaging label depicting the transportation and storage atmospheric pressure range of 500 to

1060 hPa.

IPX1

The DINAMAP

®

PRO Series Monitor is protected against vertically falling drops of water and conforms with the IEC 529 standard at level of

IPX1. Vertically falling drops of water shall have no harmful effects to the Monitor.


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Introduction

1.12 GLOSSARY OF TERMS AND ABBREVIATIONS

AC

ADC

ADU

Alternating Current

Analog to Digital Convertor

Analog to Digital Units: The Main Board has 65,536 steps which equates to 5V full scale (76 µV/ADU) Secondary Processor ADC has 256 steps which equates to 5V full scale (19.351 mV/ADU)

AM Amplitude Modulation

ASSY Assembly

BP

BPM

Blood Pressure

Beats Per Minute

DC

DMM

FET

GAL

Direct Current

Digital Multimeter

Field Effect Transistor

Gate Array logic mb Millibar mmHg Millimeters of Mercury

HCD

Hz

Host Communications Device

Hertz

SPI

TTL

UUT

VAC

VDC

VFC

LCD

LED

MAP

NIBP

Liquid Crystal Display

Light Emitting Diode

Mean Arterial Pressure

Non Invasive Blood Pressure

NiMh Nickel Metal Hydride

OSC Oscillatory

PSU

PWA

Power Supply Unit

Printed Wiring Assembly

Serial Peripheral Interface

Transistor to Transistor Logic

Unit Under Test

Volts Alternating Current

Volts Direct Current

Voltage to Frequency Convertor


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1-9

Introduction


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2

Product Description


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2-1


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Product Description

SECTION 2. PRODUCT DESCRIPTION

2.1 INTRODUCTION

DINAMAP

®

PRO Series 100-400 Monitors provide non-invasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, temperature, and oxygen saturation. These portable AC and DC operated monitors are primarily intended for use in hospital acute care settings such as outpatient surgery, accident and emergency, labor and delivery, GI/ endoscopy, and medical/surgical units.

2.2 PRODUCT CONFIGURATIONS

Each PRO Series Monitor is supplied with an accessory pack. The contents of the pack vary according to model. Unpack the items carefully, and check them against the contents checklist enclosed in one of the accessory boxes. If there is a problem or shortage, contact

GE Medical Systems Information Technologies.

It is recommended that all the packaging be retained, in case the

PRO Series Monitor must be returned for service in the future.

2.3 CONTROLS, INDICATORS, AND CONNECTORS

Descriptions of the items shown are listed on the pages that follow.

For symbol definitions, refer to Section 1 of this manual.


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2-3


2.3.1 PRO Series Monitor Rear Panel Connections

1. Battery compartment cover: Retains and protects the internal battery.

2. Mains input: Used to connect to AC power supply.

3. External power socket: To be used with approved AC-DC power converter ONLY.

4. Inactive temperature cable storage: Inactive temperature probe cable attaches here (Models 200 and 400).

5. Pole clamp: Used to clamp monitor to pole or stand.

6. Data interface connector: Host communications port (15 way Dtype RS-232 serial port) for use only with equipment conforming to

IEC 601-1. Refer to section 2.4 for connection details.


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Revision B

2.3.2 Front Panel Controls and Indicators

7. Systolic pressure display: 3-digit red LED indicates measured systolic BP in mmHg.

8. Active temperature probe holster: Temperature probe that is being used stored here (Models 200 and 400).

9. Diastolic pressure display: 3-digit red LED indicates measured diastolic BP in mmHg.

10. Temperature probe cover storage: Box of probe covers stored here (Models 200 and 400).

11. Inactive temperature probe holster: Extra temperature probe stored here (Models 200 and 400).

12. Temperature display: 4-digit red LED indicates measured temperature (Models 200 and 400).

13. °C °F display: Indicates whether temperature is being displayed in degrees Celsius or Fahrenheit (Models 200 and 400).

14. External power indicator: Green LED indicates external power status and battery charging status of PRO Series Monitor.

15. Temperature probe connector: Temperature probe cable attaches here (Models 200 and 400).


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2-5

2-6


16. ON/OFF switch: Controls on/off state of PRO Monitor; push for power on and push again for power off.

17. Battery power indicator: Yellow LED indicates operation and charge status of battery.

18. SpO

2

sensor connector: SpO

2

sensor extension cable attaches here (Models 300 and 400).

19. Mean arterial pressure display: 3-digit red LED indicates measured MAP in mmHg and shows instantaneous cuff pressure during BP determination.

20. SpO

2

pulse indicator: Yellow LED in heart symbol flashes to indicate that real-time pulse rate measurements are being derived from SpO

2

signals (Models 300 and 400).

21. Rotor: Used to highlight and select items in LCD menus; if monitor is off, pressing rotor will switch monitor on.

22. Pulse BPM display: 3-digit yellow LED shows pulse rate in beats per minute.

23. SpO

2

display: 3-digit red LED indicates oxygen saturation in %

(Models 300 and 400).

24. SpO

2

motion/artifact indicator LED: For NELLCOR, LED

Illuminates when motion artifact is detected (Models 300 and 400).

For Masimo, LED illuminates when low perfusion or low signal quality is detected (Models 300 and 400).

25. LCD (liquid crystal display): Displays all alarms, user interface messages, and configuration options.

26. Alarm silence switch: Alternately mutes and enables audible alarms; when pushed once after alarm sounds (silence on), the switch illuminates to indicate that audible alarms have been silenced for 2 minutes.

27. AUTO BP key: Press to start Auto BP mode.

28. Light sensor: Automatically measures ambient light to set LED display intensity.

29. START/STOP BP key: Press to start or stop a BP, Auto, Stat, or

Vitals determination.

30. Cuff connector: BP cuff hose attaches here.

Not Shown: The printer access door is located on the left side of the monitor. Push the latch to open the door and access the paper supply and print head.


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2.4 HOST PORT CONNECTOR (REAR PANEL)

WARNING! Auxiliary equipment connected to the DINAMAP ® PRO Series Monitor will result in the formation of an electromedical system and thus, must comply with the requirements of EN

60601-1-1/ IEC 601-1. All host port signals are

NON-ISOLATED and should be connected to equipment conforming to IEC-601-1, configured to comply with IEC 601-1-1 ONLY. Where isolation of data communication is required, GE Medical Systems

Information Technologies part number ILC1926 and 683235 (Cable

Assembly) should be used. If external alarm control is required, GE

Medical Systems Information Technologies part number 487208CR

(Isolated Remote Alarm Cable Assembly) should ALWAYS be used.

Please refer to the Information Sheet included with the isolated remote alarm cable for details.

Note: When using remote alarm, the PRO Series Monitor should be considered the primary alarm source. The secondary alarm is used for secondary purposes only.

11

12

13

14

15

9

10

7

8

5

6

3

4

Pin Assignments

Pin Function

1

2

Ground

Inverted TTL Transmit Data

Inverted TTL Receive Data

Fused +5 Volts

No connection

No connection

Ground

Remote Alarm

RS232 Request to Send (RTS)

RS232 Clear to Send (CTS)

RS232 Transmit Data (TxD)

No connection

RS232 Receive Data (RxD)

No connection

No connection


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2-7

Product

DINAMAP PRO Monitor Operations Manual-English

DINAMAP PRO Monitor Service Manual-English

Battery, 12V Lead Acid

Printer Paper (box of 10)

DINAMAP Rolling Stand


2.5 REORDER PART NUMBERS

Product Code

2018548-001

2018553-001

633132

089100

003215

NIBP:

Air Hose 12 ft Adult/Pediatric, Screw Connector

Air Hose 24 ft Adult/Pediatric, Screw Connector

Air Hose 12 ft Neonatal

Air Hose 12 ft Adult/Pediatric, Quick Disconnect

CUFF Assortment Packs:

CLASSIC-CUF

®

Assortment Pack:

Includes: 1 each: Infant, Child Small ADult, Adult, Large Adult, Thigh Cuff

107365

107366

107368

88847

2692

CLASSIC-CUF

®

Assortment Pack, Neonate:

Includes: 2 Neo #1, 3 Neo #2, 5 Neo #3, 5 Neo #4, 5 Neo #5

SOFT-CUF

®

Assortment Pack:

Includes: 1 Infant, 1 Child, 2 Small Adult, 2 Adult, 2 Large Adult, 1 Thigh, 1 Adult Long

SOFT-CUF

®

Assortment, Neonate:

Includes: 2 Neo #1, 3 Neo #2, 5 Neo #3, 5 Neo #4, 5 Neo #5

DURA-CUF

®

Assortment Pack:

Includes: 1 each: Infant, Child, Small Adult, Adult, Large ADult, Thigh Cuff

2693

2695

2694

2699

DURA-CUF

®

Assortment Pack, Adult:

Includes: 1 each: Infant, Child, Small Adult, Adult, Large Adult, Thigh Cuff

SENSA-CUF

TM

Assortment Pack, 2-Tube Screw Connectors:

2698

2697

Includes: 1 each: Small Adult, Adult, Large Adult,

NIBP Calibration Kit 320246

Additional Blood Pressure Cuff Codes are available through: http://www.gemedical.com


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Product

TEMPERATURE

IVAC

®

TURBO TEMP Kit (contains 615118 & 2008774-001)

IVAC

®

TURBO TEMP Oral Temp Probe, Long Cord

IVAC

®

TURBO TEMP Rectal Temp Probe, Long Cord

IVAC

®

Temperature Probe Covers

IVAC is a trademark of ALARIS Medical Systems

SpO

2

:

NELLCOR

®

:

Pulse Oximeter Cable DOC-10

DuraSensor Adult Oxygen Sensor

NELLCOR is a trademark of Nellcor Puritan Bennett

Masimo

®

:

Masimo

®

SpO

2

Kit (contains 2009745-001 & 2009743-001)

Adult Reusable Sensor, 1/BX (NR125)

Cable (PC08)

Masimo SET

®

is a trademark of Masimo Corporation

Product Code

2011530-001

2008774-001

2008775-001

088015

2008773-001

407705-006

2011605-001

2009745-001

2009743-001


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2-9


2.6 SPECIFICATIONS

This product conforms to the essential requirements of the

Medical Device Directive. Accessories without the CE Mark are not guaranteed to meet the Essential requirements of the

Medical Device Directive.

IPX1

The PRO Series Monitor is protected against vertically falling drops of water and conforms to the IEC 529 standard at level of

IPX1. Vertically falling drops of water shall have no harmful effects to the Monitor .

2.6.1 Power Requirements

Mains

AC Input Voltage

Protection against electrical shock

DC Input Voltage

External DC Input Fuse

Battery

Protection against electrical shock - Class 1

100/240 VAC, 50/60 Hz (nominal),

90~253 VAC, 47~63 Hz (range),

50 VA

Class 1

24 VDC (nominal), 12-30 VDC, 36 VA, supplied from a source conforming to IEC 601-1.

AC input is protected by two internal fuses, replaceable by qualified service personnel only. DC input line is protected by an internal auto-resetting fuse.

12 volt, 2.3 amp-hours protected by internal auto-resetting fuse.

Minimum operation time: 2 hrs (5 min cycle with adult cuff at

25 °C with power save mode enabled) from full charge.

Time for full recharge: 1 hr 50 min from full discharge when the Monitor is switched off and 8 hrs when the Monitor is switched on.

2.6.2 Environmental

Operating Temperature

Operating Atmospheric Pressure

Storage Temperature

Storage/Transportation Atmospheric Pressure

Humidity Range

Radio Frequency

+5° C to +40° C (+41° F to +104° F)

700 hPa to 1060 hPa

-20° C to +50° C (-4° F to +122° F)

500 hPa to 1060 hPa

0% to 95%, noncondensing

Complies with IEC Publication 601-1-2 (April 1993) Medical

Electrical Equipment, Electromagnetic Compatibility

Requirements and Tests and CISPR 11 (Group 1, Class A) for radiated and conducted emissions.


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2.6.3 Mechanical

Dimensions

Weight, Including Battery

Mountings

Height: 9.8 in (25.0 cm)

Width: 9.8 in (25.0 cm)

Depth: 6.9 in (17.5 cm)

7.8 lb (3.5 kg)

Self-supporting on rubber feet or pole mountable

2.6.4 BP

Cuff Pressure Range

(Normal operating range)

Default Target: Cuff Inflation

0 to 290 mmHg (adult/ped)

0 to 145 mmHg (neonate)

150 ± 15 mmHg (adult/ped)

110 ± 15 mmHg (neonate)



Target Cuff Inflation:

(in 5 mmHg increments)

Blood Pressure Measurement

Adult/Ped

Systolic

MAP

Diastolic

Neonate

Systolic

MAP

Diastolic

Blood Pressure Accuracy

Range (mmHg)

30-290

20-260

10-220

30-140

20-125

10-110

Meets or exceeds ANSI/AAMI standard SP-10 (mean error

≤

5 mmHg, standard deviation

≤

8 mmHg)

Maximum Determination Time

Overpressure Cutoff

120 seconds (adult/ped)

85 seconds (neonate)



Pulse Rate Range 30 to 200 beats/min (adult/ped)

30 to 220 beats/min (neonate)

Pulse Rate Accuracy ±3.5%

US Patents: 4,360,029; 4,501,280; 4,546,775; 4,638,810; 5,052,397; 4,349,034; 4,543,962; 4,627,440; 4,754,761;

5,170,795; 5,518,000

European Patents: EP122123, EP205805, EP207807


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2.6.5 TURBO TEMP

Scale °Farenheit (F)

°Celsius (C)

Range

Predictive Mode

Monitor Mode

Max: 41.1° C; 106.0° F

Min: 35.6° C; 96.0° F

Max: 43.3° C; 110.0° F

Min: 26.7° C; 80.0° F

Predictive Mode Accuracy

Monitor Mode Accuracy

± 1.0° F

± 0.6° C

± 0.1° C

± 0.2° F

(when tested in a calibrated liquid bath; meets ASTM E1112,

Table 1, in range specified) approx. 10 seconds, typical Determination Time

Use only IVAC probes and probe covers. The size, shape, and thermal characteristics of the probe covers can affect the performance of the instrument. Inaccurate readings or retention problems may occur unless IVAC probes and probe covers are used.

IVAC

®

Patents: U.S. D300,728; D300,909

2.6.6 SpO

2

NELLCOR SpO

2

Measurement Range

SpO

2

Pulse Rate

Perfusion Range

1 to 100%

20 to 250 beats per minute

0.03 to 20%

Accuracy and Motion Tolerance

Saturation

Without Motion - Adults*

Without Motion - Neonate*

70 to 100% ±2 digits


With Motion - Adults/Neo**

Low Perfusion



* Adult specifications are shown for OXIMAX MAX-A and MAX-N sensors. Neonate specifications are shown for OXIMAX MAX-N. Saturation accuracy may vary by sensor type.

** Applicability: OXIMAX MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.


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Pulse Rate

Without Motion

With Motion

20 to 250 beats/min ±3 digits normal physiologic range

55 to125 beats/min ±5 digits

20 to 250 beats/min ±3 digits Low Perfusion

Default Settings

SpO

2

(%)

SpO

2

(%)

Response Mode

Sat Seconds

Audible indicator

Waveforms

Sensor Connect/Disconnect From Patient

Pulse Detection

Loss of Pulse

HIGH: 100

LOW: 90

2 (for Mode 2: Fast Response)

0

Pitch changes continuously with saturation; volume from 0

(off) to 9

Pulse plethsysmograph waveform on LCD gain compensated

Monitor detect attachment or disconnection of sensor from patient within 15 seconds.

Monitor will detect pulse or enter no signal state within 15 seconds of being attached to patient

Monitor will detect loss of pulse from patient and enter no signal state within 10 seconds

Sensor Light Source

Wavelength Infrared: 890 nm (nominal)

Red: 660 nm (nominal)

52.5 mW (max) Power Dissipation

Nellcor Patents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136;

5,351,685; 5,421,329; 5,845,847; 5,533,507; 5,577,500; 5,803,910; 5,853,364; 5,865,736; 6,083,172; Re. 35,122 and, international equivalents.

Masimo SET SpO

2

Measurement Range

SpO

2

Pulse Rate

Perfusion Range

Accuracy and Motion Tolerance

Saturation

Without Motion - Adult/Ped*

1 to 100%

25 to 240 beats/min

0.02 to 20%



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Without Motion - Neonate*

With Motion - Adult/Ped/Neo**†

Low Perfusion‡




0 to 69% unspecified

Pulse Rate

Without Motion

With Motion

25 to 240 beats/min ±3 digits normal physiologic range

25 to 240 beats/min ±5 digits

*The Masimo SET

®

SpO2 parameter with LNOP-Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

**The Masimo SET

®

SpO2 parameter with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion before 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

†The Masimo SET

®

SpO2 parameter with LNOP-Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate’s foot at 2 to 4 cm against a laboratory co-oximeter and ECG monitor. This validation equals plus or minus, one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

‡The Masimo SET

®

SpO2 parameter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus, one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

Masimo

®

Sensor Accuracy

Sensor Model

LNOP

LNOP-ADT

LNOP-ADT Long

LNOP-PDT

LNOP-NEO

LNOP-NEO PT

LNOP-DCI (reusable)

LNOP-DCSC (reusable)

LNOP-DCIP (reusable)

NRI25 (reusable)

SpO2 range 70%- 100%

±2 digit

±2 digit

±2 digits

±3 digits

±3 digits

±2 digits

±2 digits

±2 digits

±2 digit

Resolution

Saturation (% SpO2)

2-14

1%


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Pulse Rate (bpm)

Low Perfusion Performance

1

>0.02% Pulse Amplitude and % Transmission >5%

Saturation (% SpO2) ±2 digits

Pulse Rate ±3 digits

Interfering Substances

Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.

Sensor Light Source

Wavelength

Power Dissipation

Infrared: 905 nm (nominal)

Red: 660 nm (nominal)

Infrared: 22.5 mW (max)

Red: 27.5 mW (max)

Default Settings

SpO2 (%)

SpO2 (%)

Sensitivity Mode

Averaging Time

FastSAT Mode

HIGH: 100

LOW: 90

2 (for low perfusion-Default)

12 seconds

0 (for Off)

Masimo Patents: 5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462;

6,206,830; 6,157,850, and international equivalents.


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3

Theory of Operation


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Theory of Operation


This section provides overall theory of operation and functional description of the DINAMAP PRO Monitor (hereinafter referred to as

PRO Monitor). The PRO Monitor comes in four different models, as follows:

PRO Monitor 100 - It has the capability of monitoring Blood Pressure

(BP) and Pulse.

PRO Monitor 200 - It has the capability of monitoring BP, Pulse, and

Temperature.

PRO Monitor 300 - It has the capability of monitoring Blood Pressure

(BP), Pulse, and SpO

2

.

PRO Monitor 400 - It has the capability of monitoring BP, Pulse,

Temperature, and SpO

2

.

3.2 OVERALL PRINCIPLES OF OPERATION

The following paragraphs provide a general system interface relationship. The general block diagram is located in Figure 3-1.

The PRO Monitor is a portable unit that receives input power from an external AC source, external DC source, or internal rechargeable battery.

When the ON/OFF button is pressed, the Main Board is brought out of a sleep mode and turns on the power regulators. The power regulators provide conditioned power from one of the input power sources: AC Mains, External DC, or the Lead Acid Battery. The regulated power is routed to the Printed Wiring Assemblies (PWAs) via the cable harnesses. Once the Pro Monitor is energized, a selftest is performed. The self-test automatically tests the main functions of the PRO Monitor. Failure of the self-test will set the PRO Monitor into a fail-safe mode with an audio alarm.

Under normal operating condition, the PRO Monitor is ready to record the patient vital signs using three external attachments: the temperature probe, SpO

2

sensor, and cuff. Interface with a central station or other device is accomplished through the host communication port on the back of the Pro Monitor.

3.2.1 Cuff Blood Pressure (BP) and Pulse

When the cuff and hose are attached to the Pro Monitor and Non-

Invasive Blood Pressure (NIBP) determination is initiated, the pump inflates the cuff. Pressure transducers PT1 and PT2 monitor pressure information. The pneumatic manifold has two valves, which are used to deflate the cuff. Valve control is through the Main Board. Once determinations are made for the systolic BP and diastolic BP, the


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Main Board calculates the pulse rate/Mean Arterial Pressure (MAP).

The results are then displayed on the front panel (seven segment

Light Emitting Diodes (LEDs) and sent to the printer.

The Pneumatic Valve/Manifold (PVM) device has an overpressure sensor built-in to protect against over-inflation. If an over-inflation condition occurs, the OVERPRESSURE signal is routed to the PVM to release the air pressure. The Main Board also, generates an alarm condition with the speaker sounding and a message in the Liquid

Crystal Display (LCD).

3.2.2 Temperature (Model 200 and 400)

The PRO Monitor uses Alaris Turbo Temp technology to measure patient temperature. The Turbo Temp probe contains a heating element that pre-heats the probe to reduce determination time. The heating function is controlled by the Main Board. The Turbo Temp probe also contains a thermistor that indicates the temperature.

When the probe is attached to the temperature connector and patient, the signal generated by the thermistor is routed to the Main Board.

The Main Board converts the thermistor signal along with status information (i.e ORAL or RECTAL probe indicators) to a DIGITAL signal. The Main Board then processes the DIGITAL signal and displays the patient temperature on the UI Board and printer in

Celsius or Fahrenheit.

3.2.3 SpO

2

(Model 300 and 400)

The SpO

2

probe has a built-in sensor. When the SpO

2

sensor is attached to the SpO

2

connector and patient, the probe senses the heart rate and oxygen saturation. These analog signals are routed to the SpO

2

PWA. The analog signals are analyzed on the SpO

2

PWA.

The results are digitized and sent to the Main Board via opto couplers. The couplers provide for patient isolation as well as serial data interface. The Main Board processes the data and routes it to the appropriate displays and/or printer.

A reset signal to the SpO

2

PWA is also provided so that the power up sequencing is corrected. If the SpO

2

circuit quits communicating to the Main Board, the Main Board will attempt to reset the SpO

2

PWA.

3.2.4 Host Communication Port

The Host Comm Port is used to interface the Monitor with other electronic devices (a central nurse’s station or remote alarm device.)

Signals can be sent to the Monitor to initiate blood pressure determinations and other functions. Patient data can also be retrieved through this port. For further information, reference the DINAMAP

PRO 100-400 Series Host Communication manual.


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3.3 FUNCTIONAL DESCRIPTION

The following paragraphs provide the functional interface relationship.

The Pro Monitor contains a number of electrical & electro-mechanical assemblies. These assemblies are:

Power Supply Unit (PSU) PWA

PSU Module

Main Board

SpO

2

PWA (optional)

Pneumatic control device

Liquid Crystal Display (LCD) Assembly

Printer PWA w/printer

3.3.1 PSU PWA

The PSU PWA is a low voltage DC power supply. The PSU PWA is designed to operate from the output of the AC MAINS PSU module,

EXTERNAL DC line source, or from a 12-volt rechargeable lead-acid battery. When the PSU PWA receives the EXTERNAL DC, a portion of that voltage is routed to an analog input of the Secondary

Processor. The Secondary Processor uses this signal to determine the available power sources. If a valid external power source is available, LED lights to indicate that external power is available. If an external power source exists, and a battery source is detected, the

Secondary Processor will send a command to turn on the Battery

Charger circuitry. If there is no external power source or the external power source is below the required voltage, the PSU PWA will automatically default to use the battery. Since the Pro Monitor is now operating from the battery voltage, a sample of the battery source is applied to Analog Digital Converter (ADC) circuit of the Secondary

Processor. From this, the Secondary Processor can determine the charge state of the battery.

3.3.2 PSU Module

The PSU module is an AC Mains to DC converter. The PSU module receives AC power from an external source. When AC INPUT is applied to the PSU module, the module AC/DC Converter changes the AC INPUT supply via rectifier circuit to a high voltage DC. The DC power is then routed through a high frequency switching converter and regulated to 24 vdc. This supply is connected to the PSU PWA for further regulation.

3.3.3 Main Board

The Main Board is configured with Programmable Read Only Memory

(PROM), Random Access Memory (RAM), LED Display, Hard Keys,


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16 Bit ADC, Primary Processor, and Secondary Processor. The

Primary Processor services and controls the Patient Parameter

Interface (PPI) devices and display backlighting. The Secondary

Processor controls the seven segment LED display, sound generation, real time clock, and system timing verification. The processors receive DC power from the PSU PWA. When the PPI devices transmit analog data to the Main Board A/D converter, the

Primary Processor perform algorithm calculations. Once all the calculated parameter values are compiled, the data is then transmitted to the LCD and printer via Secondary Processor.

Concurrently, the calculated parameter values are being stored in the non-volatile RAM. Calibration and other variable settings are stored in the Electrically Erasable Programmable Read Only Memory

(EEPROM).

The Main Board backup voltage, derived from either NiMH battery or an external power source, appears on the Main Board supervisory circuit. The Main Board supervisory circuit generates the RESET and

HALT signal for the Primary Processor. It also, allows EXTERNAL DC voltage to the RAM and Secondary Processor when the system is ON or battery backup voltage to power the RAM and Secondary

Processor when the system is OFF.

If the Primary Processor fails to reset its watchdog timer, the Primary

Processor sends a low level on its watchdog output to the Pneumatic

Control Gate Array Logic (PCGAL). If the Primary Processor detects system faults or overpressure, it will notify the Secondary Processor of system failure condition. The Secondary Processor in turn, sends a

FAILSAFE signal to the PCGAL and Tone Generator. When the

PCGAL receives the FAILSAFE signal, it sends a DEFLATE signal to the Pneumatic Valves to depressurize the system to atmosphere.

Once the Tone Generator receives the FAILSAFE signal, it sends an audio frequency (ALARM signal) to the speaker. During the fail-safe mode the following will also occur:

Parameter monitoring disabled

Remote alarm control inactive

Graphic LCD displays fault error code

Pneumatic safe state (deflate the cuff, pump off)

Normal communications interface disabled

Hard keys and rotary switch inactive

When a low or high ambient room lighting occurs, the Primary

Processor uses it’s supervisory circuit to increase or decrease the graphic backlighting, automatically.

3.3.4 SpO

2

PWA (Optional)

The SpO

2

PWA provides continuous readings of oxygen saturation and pulse rate. Additional circuitry provides power, data


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Theory of Operation communications, and isolation between SpO

2

PWA and Primary

Processor.

Patient data received from the finger sensor is filtered, amplified, and analyzed on the SpO

2

PWA. The information is sent to the Main

Board via the optically coupled electrically isolated serial connection.

The Primary Processor receives the data and distributes it to the appropriate display. The data is also sent to the printer via the

Secondary Processor.

3.3.5 Pneumatic Control Device

The Main Board transducers PT1 and PT2 sense cuff pressure and raw oscillatory information. The analog signals are amplified, buffered, and sent to an Analog to Digital (A/D) Converter. The converter changes the analog signals to digital signals and routes these signals to the Primary Processor. The Primary Processor receives the digital signals via the data interface.

Appropriate valve and pump control signals are sent from the Primary

Processor to the PCGAL. The PCGAL then generates the appropriate drive signals to the pump and valves.

If a fail-safe mode or overpressure condition occurs, the PCGAL provides the appropriate control signals to insure a safe condition, where the cuff vents to atmosphere pressure.

3.3.6 LCD Assembly

The LCD assembly is used as a message center. It displays patient vital signs, alarm status, monitor set-up, limit violation, BP cycle and the time the data was received. The Primary Processor controls the

LCD assembly. When the parameter signals are read by the Primary

Processor, it decodes these signals and routes the digitized signals to the graphic LCD.

The LCD assembly is equipped with a variable lighting feature for the graphic display. The Primary Processor controls the lighting feature, automatically. When a low or medium ambient lighting condition occurs, the Primary Processor sends a BACKLIGHT signal to adjust the graphic display lighting with respect to the room lighting condition.

If the lighting condition is high, the Primary Processor sends a

BACKLIGHT_1 signal to switch off the graphic display lighting.

3.3.7 Printer PWA w/Printer

The Printer PWA w/printer communicates to the Primary Processor via Secondary Processor data line. The printer receives power from the Main Board via the Printer PWA. The printer sends a DATA OUT


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(CONTROL DATA) signal to the Secondary Processor to notify of it’s presence. When a print command is sent to the printer from the

Secondary Processor, the following will occur:

CLOCK signal - transfer the data into print head

DATA IN - serial dot to be printed

LATCH signal - latch the data stream into the head

STB1-6 - cause the head to print various sections

Together these signals (CONTROL DATA) cause the printer to print a graphic hardcopy of the patient vital sign values and trend data. It also causes the printer to print hardcopy of error logging and service record data.

The printer has a built-in sensor to monitor the printer paper level.

When the printer is out of paper, it sends a PAPER OUT signal to the

Secondary Processor.


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4

Calibration &

Maintenance


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Calibration & Maintenance

SECTION 4. GENERAL MAINTENANCE


This section contains maintenance procedures for the DINAMAP

®

PRO Series 100-400 Monitor, including description of the software screens and menus used to adjust, configure and check the Monitor.

Also included are procedures to recalibrate the Monitor. Procedures pertaining to SpO

2

and temperature functions apply only to PRO

Monitors equipped with these features.

4.2 FUSES

The PRO Monitor power circuits incorporate five fuses. None of the fuses are externally accessible. Two mains fuses are mounted on the

AC mains converter board, and are not serviceable by the user.

If a mains fuse blows, the Monitor will not change from battery power to mains power when it is plugged in to an AC power source. To confirm a fuse problem, remove the battery, plug the unit in, and turn it on. If the PRO Monitor does not operate, the probable cause is an open mains fuse. The other three fuses are:

FS1 - Self resetting; DC input; PSU board

FS2 - Self resetting; battery; PSU board

FS3 - Self resetting; host port power; PSU board

4.3 PERIODIC MAINTENANCE

Periodic maintenance tasks include cleaning the PRO Monitor, checking pressure calibration, pneumatic leakage, pneumatic system overpressure point, temperature calibration (200 and 400), and verification of the SpO

2 system (300 and 400).

4.3.1 Cleaning the Monitor

The exterior of the PRO Monitor may be wiped clean with a cloth slightly dampened with mild detergents or standard hospital bactericides. Cleaning with isopropyl alcohol or similar solvents is not recommended.

Do not immerse unit.

Do not immerse hoses.

Do not immerse cuffs without prior application of cuff hose caps.


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CAUTIONS

Moisture or foreign substances introduced into the pneumatic system will cause damage to the unit. Calibration equipment should always be kept dry and clean.

4.3.2 Power-Up Checks

When the PRO Monitor is powered up, it conducts a series of selftests to ensure the displays and other functions are operating normally. Some malfunctions generate fatal errors and put the

Monitor in fail-safe mode. In this mode, the patient monitoring features are disabled and the unit produces an audible alarm. Other malfunctions do not interfere with normal operation, but should be repaired at the next opportunity.

As part of a periodic maintenance routine, observe the power-up selftests, and service as required.

LED Display Check

All seven segments of the LED digits are illuminated during the power up sequence. The segments light in a sequence beginning with the upper left segment.

LCD Display and LCD Backlight Check

Observe the LCD during power up. Confirm that all of the pixels on the LCD display are lit momentarily and the backlight is powered during initialization. The backlight is only noticeable in a dimly lit room. Confirm that the display indicates the software version in inverted format (white on black).

NIBP Calibration Check

If the NIBP system is uncalibrated, the Monitor turns on directly into service mode and displays a service menu. Refer to 4.7 PRO Monitor

Calibration Procedures.

Speaker Check

During power up, the audio system generates three short beeps, followed, after a brief pause, by three more beeps. If the speaker generates distorted sounds or no sound, it is faulty.

Remote Alarm Switching Check (Optional Accessory)

When the PRO Monitor is off, the remote alarm switches to an alarm state. The system clears the alarm state during power up. If the remote alarm does not change states, it is faulty.

Preventative Maintenance Reminder (PM)

The Monitor offers an option (Preventative Maintenance Reminder

[PM]) that allows you to specify the number of days between monitor maintenance checks; it also notifies you when it is time for PM. This option is enabled through Service mode only. If the PM feature is enabled and the user-selected cycle time has elapsed, a reminder


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Calibration & Maintenance screen appears upon power up. You can bypass this message to go to the Main menu by pressing any key on the Monitor.

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4.3.3 External DC Supply (Optional Accessory) and Battery

The power indicators on the lower left on the front of the PRO Monitor show the power source and charge status of the battery. The external power indicator LED continuously glows green to show the battery is charging.

The indicator flashes every four seconds to show an external power source is connected, but is not charging the battery. Either a battery is not installed or the external DC input voltage is too low.

Checking the Battery

1. Power on, and wait for the PRO Monitor to initialize. Confirm the external power indicator is lit and the battery LED is off.

2. Remove the battery and confirm that external DC LED on the

Monitor flashes.

3. Fit the battery and disconnect the external power supply. Confirm the external power indicator is off; the battery LED glows yellow; and the battery icon appears on the LCD, toggling with the time indicator.

If the battery power is low, the battery LED flashes every four seconds and the battery icon on the LCD changes.

4. Reconnect the external power supply, and verify that the battery

LED is off.

4.3.4 Care of the Storage Battery

It is best to keep the battery charged as fully as practical. Never store the Monitor with the battery in a discharged condition. When the battery no longer holds a charge, remove and replace with one of the same part number.

To ensure that the battery is ready for portable operation, keep the unit connected to AC mains whenever possible.

Repeated failure to fully charge the battery significantly reduces battery life.


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Avoid storing batteries at temperatures above 77° F (25° C). High storage temperatures can dramatically increase the selfdischarge rate of battery.

4.3.5 Checking Calibration

Perform the test procedures described in 4.6 whenever the accuracy of any of the parameters is in doubt.

4.4 Clinician Mode

The PRO Monitor provides a special mode named Clinician Mode.

This mode is accessed from the More… option on the Main menu, and requires a code before a user can access it.

The Clinician Mode enables the user to:

Verify NIBP calibration and PM dates

Change the alarms to “Permanent Silence” mode

Set target inflation pressure

4.4.1 Accessing the Clinician Mode

This section provides an overview of the Clinician menus. For more information and details of operation, see the PRO Series 100-400

Monitor Operation Manual.

To enter Clinician Mode from the Main menu, use the rotor control and LCD.

1. Select the More… button.

2. Select the Service button.


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3. Clinician Mode requires a four-digit code. Turn the rotor to highlight a number, and push to make a selection. Enter access code: 1 2 3 4.

4.4.2 Clinician Mode Main Menu

The Clinician Mode Main menu, pictured above, provides access to the options normally required for routine use of the PRO Monitor. The individual buttons on this menu are described briefly below.

Press Button

Selecting the Press button displays the target pressure dialog box, pictured above, which sets the default target inflation pressure for a

BP cycle. The factory default is 150 mmHg for adults and 110 mmHg for neonates. This is indicated by the “Auto” label at either end of the adjustable range. Choosing “Retain Values” allows the user to preset the number of minutes for which displayed values are retained on the

Monitor.

Revision B

Selecting the Info button displays the most recent calibration dates of the BP. Choose OK to return to the Service menu.


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4-8

Selecting the Silence button displays the dialog box, pictured above, which mutes all the alarms except the fail-safe alarm. The alarms are disabled until the Monitor is either powered off and on again or the

Silence button is pressed. Choosing either Yes or No will exit the menu. If silence is confirmed, the Alarm Silence button lights.

More... Menu Button

The More... menu accesses more options that allow the user to permanently change the default settings.

Main Button

Select this button to exit the Service menu and return to the Main menu.

4.4.3 Clinician More... Menu

The Clinician More… menu accesses the options to change the default settings of several PRO Monitor functions. These options are summarized below.

Trend Button

Displays a dialog box to automatically clear trend data on power up.

The default setting is Yes. In the default setting, trend data is cleared when the PRO Monitor is shut off. Select No to retain the trend data on power-down.

Print Button

Displays a dialog box to restore the print mode on power up to the user-selected print mode (auto or manual) or the default print mode.

The print mode can be selected through the Print button on the Main menu. The current mode is displayed in the lower right corner on the

LCD. Select No and the PRO Monitor powers up in manual print mode. Select Yes, and the monitor retains the user-selected mode.

Set BP Button

Displays a dialog box to power up in a user-selected BP mode (auto/ manual). Select Yes to preserve the user-selected BP mode. Select

No to power up the PRO Monitor in manual mode.

SpO

2

Button

Selecting Yes enters the SpO

2 configuration menu. Selecting No returns the user to the More… menu. This menu displays a dialog box that enables the user to adjust the sensitivity of the SpO

2 parameter and to enable the FastSAT Feature (if equipped as a


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Masimo unit). If the Monitor is equipped for Nellcor SpO

2

, this menu allows the user to set the Response Mode and SatSeconds feature.

Alarms Button

This button accesses a dialog box to enter the alarms configuration menu. Selecting Yes enters the menu. Selecting No returns the user to the More… menu.

Select Reset to return all the alarm limits to the default settings. The illustration above shows the default settings.

The user can adjust the alarm limits within the ranges specified in the table below. The high limit must be at least one step higher than the low limit.

Parameter

Systolic High

Systolic Low

Diastolic High

Diastolic Low

MAP High

MAP Low

BPM High

BPM Low

SpO2 High

SpO2 Low

Alarm Limits Table

Range

35 - 290

30 - 285

15 - 220

10 - 215

25 - 260

20 - 255

35 - 250

30 - 245

21 - 100

20 - 99

140

50

150

50

180

30

130

15

Off

90

Default

Note: Predictive temperature has no alarm limit alarm.

Select Save to save the displayed settings and return to the More… menu. Select Cancel to abandon any changes and return to the

More… menu.


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4.5 SERVICE MODE

The Service Mode provides the same features as the Clinician Mode and adds these functions:

Check the BP calibration

Re-calibrate BP

Adjust the pneumatic system overpressure point

Configure communications with a host computer

Change the language of operation

4.5.1 Accessing the Service Mode

To enter Service Mode from the Main menu, use the rotor and LCD.

1. Select the More… button.


3. The service menu requires an access code. Turn the rotor to highlight a number, and push to make a selection. Enter access code

2 2 1 3.


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4.5.2 Service Mode Main Menu

The options accessed through the Main Service menu, pictured above, allow the technician to check basic functions of the PRO

Monitor, calibrate the NIBP system, and set the language of operation.

Note: These menus and adjustments should be used only by qualified service technicians.

NIBP Button

The NIBP button accesses the NIBP Service menu. Use this menu to calibrate and check the NIBP transducers and the overpressure circuitry (Section 4.5.3).

Info Button

This button displays the date of the most recent NIBP calibration and

PM check. Select OK to return the display to the Service menu.

System Button

This button accesses the System menu. The options on this menu set the display language, communications protocols, test the EEPROM, and print the error log (Section 4.5.4).

Silence Button

Revision B

Selecting the Silence button displays a request to confirm the choice.

This is a working option available only through the Clinician Mode

(1234). Alarms are disabled when in Service Mode.

Yes mutes all patient alarms until the PRO Monitor is powered off and on again or the alarm Silence button is selected again to enable the alarms. A confirmation menu appears (pictured above) on the display.

Selecting either Yes or No exits the menu. If silence is confirmed, the alarm Silence button on the front panel illuminates momentarily.


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4.5.3 NIBP Menu


The options on the NIBP menu, pictured above, are used to calibrate and test BP functions of the PRO Monitor.

Check Button

This button allows the NIBP calibration to be checked. In this mode, the Monitor functions as a digital manometer. The systolic LED displays the output of PT1, and the diastolic LED displays the output of PT2.

With no hose attached, the systolic and diastolic displays will indicate

“000.” See Section 4.7 for a more detailed description of this mode and the calibration procedure.

Cal Button

This button initiates the calibration procedure. See Section 4.7 for a step-by-step description of this procedure.

Pop Off Button

This button functions in a similar manner to the Check button, but the overpressure point is set to the neonate value. See Section 4.7 for a more detailed description of using this function.

Cycle Button

This button allows the user to activate the Preventative Maintenance

(PM) reminder notice. When you select this button a menu appears, allowing the user to select the number of days that elapse between the last NIBP PM date and the activation of the PM reminder screen.

Cycle times range from 30 to 365 days in 5-day increments and OFF.

If you choose OFF as your cycle time, the PM reminder screen is disabled.


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During a maintenance check, the current date set on the Monitor is stored in the eeprom as the last PM date when:

1. An NIBP calibration completes successfully.

2. The Check button under the NIBP button in the Service Mode

Menu is selected.

3. The Pop Off button under the NIBP button in the Service Mode

Menu is selected. If the dates captured by the Check or Pop Off buttons would ever precede the calibration date, the PM date would default to the calibration date.

When the number of days since the last PM exceeds the specified

Cycle number of days, a full-screen warning page will be displayed after the power-up screen, informing the user that preventative maintenance is due. This screen can be dismissed by pressing any front panel key, and normal operation will begin.

The date of the last PM and Calibration can be found by selecting the

Info button in the Service Mode Menu or by selecting the Info button in Clinician Mode Menu.

Preventative Maintenance Reminder Screen

Cancel Button

This button takes the user back to the Service Mode NIBP Menu.

Changes to the Cycle time will not be retained if the Save button has not been selected before leaving the menu.

Save Button

This button stores the currently displayed Cycle time in the eeprom.

The Cycle time is retrieved for analysis on power-up to determine whether the Preventative Maintenance Reminder screen should be shown.

OK Button

This button returns the display to the Main Service menu.


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4.5.4 System Menu


The System menu, pictured above, accesses the options that modify the basic configuration of the PRO Monitor, test the EEPROM, and print the error log.

Language Button

This button displays the language choices. The language dialog boxes are not pictured. The PRO Monitor software can display menus in six languages: UK, USA, German, French, Dutch, and Spanish.

Selecting any language button removes all other language buttons from the screen, indicating that the remaining button is the chosen language. Selecting Clear restores all the language buttons, allowing the user to select again. OK saves the selection and a dialog box requests that the Monitor be turned off. If no language is selected when OK is pressed, the language is stored as undefined. In this case, the Monitor prompts the user to select a language on every power up until a selection occurs.

Comms Button

This button accesses the Communications menu. The settings on this menu configure communications with a host computer when PRO

Monitors are connected to a network.

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The Remote Op check box toggles remote operation. When on, a check mark (

√) appears in the box. When on, the PRO Monitor responds to external commands and can initiate a BP determination when prompted by a host computer. Remote operation requires

DINAMAP

®

Host Communications Protocol, which is described in the

DINAMAP

®

Host Communications Reference Manual.

The Standard check box sets the host comms protocol to standard format, and the baud rate at 9600 bps.


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The Address box sets the Monitor address within a range of 32 to

126. Address 32 is not unique. All monitors, regardless of unit address, respond to commands to unit address 32.

Selecting the 1846 button sets the comms protocol to 1846 format, and the baud rate to 600 bps.

The baud Rate can be set to 300, 600, 1200, 2400, 4800, 9600, or

19200.

Select OK to return to the Main Service menu. eprom Button (EEPROM Testing)

This button initiates a test of the read and write functions on the

EEPROM. The test is repeated 20 times. The results are displayed on the LCD and recorded in the error log.

Err Log Button

This button generates a printout of the last 20 system errors that have occurred on the unit. The system and secondary processor software versions are also listed on the error log.

ID Tag Button

Selection of the ID Tag button opens a menu that allows the user to enter a 12-digit Monitor Asset Tag for their own use. If the Asset ID

Tag is not equal to zero, the ID tag number will be displayed at the top of the screen upon power-up, before the Monitor displays the Main

Menu. If the value is equal to zero, the ID Tag option is disabled and not shown on the start-up screen upon power-up.

Input Asset Tag Digits

Selection of the individual digit buttons (0 to 9) in this menu allows the user to input an Asset ID Tag. Use the SelectKnob to choose the digits of the tag for the Monitor. You must select Save to permanently change the Asset ID Tag. The choice of digits range from 0 to 9.

Revision B

Back

Selection of this button erases the last digit chosen for the Asset ID tag. The Save button must then be selected for this to be a permanent change.

Clear

Selection of this button resets the Asset ID tag number being created back to zero, allowing a new number to be input or to turn the feature


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Calibration & Maintenance off. The Save button must then be selected for this to be a permanent change.

Cancel

Selection of this button takes the user back to the Service Mode

System Menu. Changes to the Asset ID tag will not be retained if the

Save button has not been selected before leaving the menu.

Save

Selection of this button enters the Asset ID Tag number being created in eeprom. None of the operations of the Digit, Clear, or Back buttons are permanent until the Save button is selected. On powerup, this saved number will be displayed on start-up screen.

4.6 PRE-SERVICE TEST PROCEDURES

The following procedures can be used to check the primary functions of the PRO Monitor before releasing the unit for clinical service.

The Monitor is tested by applying various stimuli to the sensor interfaces or by measuring of specific parameters. The test procedures employ features of the operational software and test modes of the service menus.

A guide to the Monitor controls, indicators, and connectors is in

Section 2 of the PRO Monitor service manual.

Test Equipment

1. Digital Pressure Gauge 0-375mmHg, 0.2% accuracy, Digitron

P200L or similar.

2. NELLCOR ® SpO

2

Simulator Model SRC-MAX or similar for Nellcor

SpO

2

or equivalent.

3. Biotek SpO

2

Simulator for Masimo ® SpO

2

or equivalent.

4. NIBP Calibration Kit P/N 320246, or similar.

5. IVAC ® Probe Simulator TE 1811.

Test Conditions

Testing shall be conducted with an ambient temperature of 25

°C ± 5

°C (77 °F ± 9 °F).

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4.6.1 SpO

2

Checks (PRO 300 & 400)

For Monitors equipped with Nellcor SpO

2

On occasion when testing the integrity of the Nellcor oximetry system, abnormal results may occur when introducing large changes in the pulse rate and/or pulse amplitude. Extreme changes in rate sent to the Nellcor sensor by the SpO

2

simulator may cause the SpO

2 algorithm to completely miss finding the pulse rate.


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This is an expected result. To work around this, incrementally step up or down the settings on your SpO

2

simulator and allow the Monitor to detect and display the new pulse rate or saturation.

Nellcor recommends use of the SRC-MAX Portable Tester for use with PRO Monitors equipped with the Nellcor SpO

2

system.

For Monitors equipped with Masimo SpO

2

Masimo recommends BIO-TEK SpO

2

simulators.

1. Connect the appropriate SpO

2

simulator and cable to the SpO

2 connector.

2. Verify the unit displays:

Pulse value

Saturation value

Signal Strength bar graph

3. Disconnect the SpO

2

cable from the simulator.

4. Verify the unit generates an “SpO

2

SENSOR OFF” alarm and the speaker is sounding.

5. Press the Silence button.

6. Verify the sound has stopped but the error remains displayed.

7. Reconnect the SpO

2

sensor.

8. Verify the unit displays:

Pulse Value

Saturation value

Signal Strength bar Graph


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4.6.2 Leak Test

This test performs a leak test of the pneumatic system.

Equipment required:

CRITIKON

®

Adult Blood Pressure Cuff (P/N 2774)

12 foot Gray, Adult/Pediatric Air Hose (P/N 107365)

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Figure 4-1

1. Secure the Adult-size cuff to the 12-foot air hose. Attach to the

PRO Monitor as shown in Figure 4-1. Secure the BP cuff around a rigid, unbreakable object that measures at least 2 inches in diameter.

2. Ensure the index-line of the CRITIKON

®

Blood Pressure Cuff is properly aligned within the range-markers on the opposite end of the cuff.

3. Power on the PRO Monitor and select More...

4. Select the Service option and input 8 3 7 8.

5. From the Super Service menu, select the NIBP option.

6. From the NIBP menu, select the LEAK option.

The leak-test sequence closes both valves and turns on the pump.

The PRO Monitor will self-pressurize the pneumatic test setup to approximately 200 mmHg. After settling for 45 seconds, the test pressure value will be displayed in mmHg on the LCD. After 30 seconds, the system displays the final pressure. Confirm that the pressure has fallen no more than 5 mmHg.


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4.6.3 NIBP Calibration Check

This procedure verifies the linearity and calibration for both pressure transducers (PT1 and PT2) over the range 0-250 mmHg.

To verify calibration it is necessary to have the following test equipment:

- 2-tube NIBP hose, 12ft, p/n 107365

- DINAMAP Adult BP cuff p/n 2774 (or equivalent)

- Calibration Kit p/n 320246 with a manual inflation bulb

- NIST calibrated single-tube manometer

Revision B

Figure 4-1

1. Set up the unit and calibration equipment as shown in Figure 4-1.


3. Select the Service mode and input 2 2 1 3.

4. From the Service menu, select the NIBP button.

5. From the NIBP menu, select the Check button.


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6. Using the inflation bulb, apply the following pressures (measured by an external digital manometer) and confirm that the Monitor readings agree with the following table for both PT1 and PT2 channels.

7. If calibration is required, refer to Section 4.7.1.

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4.6.4 Neonate Overpressure Check




4. From the Service menu, select the NIBP button, then select the

Popoff button.

Note: If the overpressure point is out of range, adjust the overpressure potentiometer as described in 4.7.2.

5. Using the inflation bulb, increase applied pressure until overpressure occurs. Confirm that pressure at that point is between

150 mmHg to 165 mmHg and system pressure falls to less than 20 mmHg within 4 seconds.

6. Power off the PRO Monitor.

7. If calibration is required, refer to Section 4.7.1.

4.6.5 Adult Overpressure Check





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4. From the Service menu, select the NIBP button.

5. Select the Check button.

6. Increase applied pressure until overpressure occurs. Confirm that pressure at the overpressure is between 300 mmHg and 330 mmHg and the system pressure falls to less than 20 mmHg within 8 seconds.

7. Switch off the PRO Monitor and disconnect the calibration kit.

8. If the Monitor fails this test, re-calibrate the unit as described in section 4.7.2.

4.6.6 Temperature System Check (PRO 200 & 400)

The PRO Monitor Series 200 & 400 temperature systems use

ALARIS temperature probes. This system is self-calibrating. The only maintenance required is to verify that the temperature functions are working properly. These checks require an IVAC probe simulator (P/

N TE 1811), available from ALARIS Medical Systems, Inc., San

Diego, CA. GE Medical Systems Information Technologies does not stock this tester.

To check the temperature system, connect the IVAC probe simulator to the temperature probe connector on the front panel, and insert a temperature probe into the active holster.

1. Power on the PRO Monitor.

2. Remove the temperature probe from the probe holster to initiate a temperature reading.

Set the probe simulator to 98.6 and verify that the LCD temperature display reads 98.6

°F ±1.0°F. The numbers on the temperature LED displays should be flashing at this point, indicating the monitor is in a real-time monitor mode.

A range of temperatures can be checked, by using the other values on the probe simulator (98.0, 80.2, 102.0, and 107.8).

Broken Probe Sensing

Set up the equipment and the probe simulator as in the previous procedure. Rotate the temperature selector on the temperature simulator to B.P. verify that the Temperature display reads 106.0

°F

±0.2°F. Next. press BROKEN PROBE on the simulator, verify that the

LED display on the Monitor changes to two dashes, indicating a fault condition.

If the PRO Monitor temperature system does not pass these tests, the Main PWA needs to be replaced.


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4.6.7 Printer Test

This test generates a sample printout from the printer. If no paper is in the printer, the Monitor generates no alarm.


2. Select the Service button and input 8 3 7 8.

3. From the Super Service Menu, select the Print button,

Ensure the printed test page is clear and easy to read.

4.7 PRO MONITOR CALIBRATION PROCEDURES

Calibration procedures include calibration of the transducers and adjustment of neonatal and adult overpressure points. These tests require a manometer and an inflation bulb attached to the PRO

Monitor as shown in Figure 4-1.

The following procedure describes the steps required to calibrate the pressure transducer. Disassembly is not required.

4.7.1 Calibrating the NIBP Transducer

1. Set up the Monitor and calibration equipment as shown in Fig. 4-1.

2. Power on the PRO Monitor.

3. Verify that calibration equipment reads 0 mmHg of pressure.

Note: If the PRO Monitor displays the language choice menu, select a language. Select OK and reboot the system.

4. Select the More… button from the Main menu.


6. Enter the Service Mode access code 2 2 1 3.

7. Select the NIBP button from the Service menu.

Important: From this point, the timing is critical. Before proceeding, review the following steps.

Setting the Calibration Points

8. Select Cal from the NIBP menu.

9. The Monitor displays “Set Pressure to 0 mmHg.”

10. Ensure calibration test equipment is at 0 mmHg.


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11. Press Accept to continue or Cancel to quit this procedure.

12. The Monitor displays “Set Pressure to 200 mmHg.”

13. Using the inflation bulb, apply the pressure (200 mmHg) and

HOLD the pressure. Press Accept to continue or Cancel to quit this procedure.

14. If Accept is chosen, the Monitor will vent the system to atmosphere. Immediately prior to venting, the Monitor stores the set pressure reading into system memory.

The zero reading and the 200 mmHg reading are the only points used for calibration. It is important to ensure that the correct pressures are applied at these two points.

After venting, the Monitor displays “Calibration is Complete” or

“Calibration Failed.”

If the calibration fails, turn off the Monitor, check the calibration equipment and repeat the process. Refer to a GE Medical Systems

Information Technologies service representative if calibration is still unsuccessful. When the calibration is successful, the following will be displayed on the LCD, “Wait...Storing values,” then after a few seconds the LCD displays, “Turn Monitor off.” The PRO Monitor is now accurately calibrated and can be switched off.

Check the calibration of the unit by repeating the BP-related procedure in 4.6.3.

4.7.2 Overpressure Adjustment of a Two-Pot System

This procedure describes how to set the overpressure thresholds.

See Figure 4-2 for adjustment locations.

Revision B

Figure 4-2


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4-24


Adjusting the overpressure requires opening the PRO 100-400

Monitor and adjusting the overpressure potentiometers on the Main board.

1. Enable Service Mode.

a. Power on the Monitor.

b. Select the More... button from the Main menu.

c. Select the Service button.

d. Enter the Service Mode access code 2 2 1 3.

e. Select NIBP.

2. Select the Check button. This button sets the overpressure point to the adult value and closes the pneumatic valves.

3. Adjust potentiometer VR1 fully counter-clockwise.

4. Manually inflate the system pressure to 315 mmHg (the optimal default Adult Overpressure setting).

5. Once the manometer displays 315 mmHg, adjust VR1 clockwise until the valves release the pressurized system.

6. Select the Check button again, and verify that the overpressure trips at 315 mmHg ± 10 mmHg.

7. Select the Pop off button. This button sets the overpressure point to the neonatal value and closes the pneumatic valves.

8. The unit will display three zeros in the systolic and diastolic windows.

9. Adjust VR2 (more to the middle of board) fully counter-clockwise.

10. Set the cuff pressure to 157 mmHg ± 2 mmHg using your connected NIBP test setup.

11. The air pressure within the system may fluctuate initially. Verify pressure with your external manometer.

12. Adjust VR2 clockwise until the pressure is released and the

Monitor displays Systolic: 000 and Diastolic: 000.

13. Select the Pop off button again, and verify that the overpressure trips at 315 mmHg ± 10 mmHg.

NOTE: A transducer calibration must be performed after changing the overpressure thresholds to save the levels into the EEPROM. These levels are used for a self test during normal operation.


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4.8 ELECTRICAL SYSTEM SAFETY CHECKS

The PRO Monitor is designed to protect the patient from electric shock. To ensure the integrity of these safeguards, use a safety analyzer to perform the following leakage current tests. These tests should be performed on every unit whenever the case is opened before it is returned to clinical service. If any reading exceeds the limit specified, do not return the unit to clinical service.

Ground Leakage

Measure ground leakage current with normal polarity, reverse polarity, and open neutral. Limit is 500 µA.

Temperature System Leakage (PRO 200 & 400)

Set your analyzer to measure leakage current with mains voltage applied to the test probes. Use a temperature plug with the leads shorted and apply the test probe of the analyzer to the leads. The leakage reading should be less than 150 µA.

SpO

2

System Leakage (PRO 300 & 400)

Set your analyzer to measure leakage current with mains voltage applied to the test probes. Use an SpO

2

plug with the leads shorted together and apply the test probe of the analyzer to the leads. The leakage reading should be less than 150 µA.

4.9 FEATURES SELECTION

The PRO Monitor allows the user to turn features (e.g., SpO

2

, Temp,

Printer) on and off. To access this option:

1. Power on the PRO Monitor and select the More... button.

2. Select Service mode and enter 3122.

3. Select the feature button you wish to change: a. Select SpO

2

: (NELLCOR, MASIMO, or NONE) Selecting this button allows you to turn the SpO

2

parameter on or off.

Choose the type of SpO

2

technology (Nellcor or Masimo) that is in your Monitor to turn it on or off by using the rotor to select the option. Once you have made your selection, a small check mark

9 appears next to the box that contains both a

9 and an” x.” If your

Monitor does not have an SpO

2

parameter, the NONE box should be selected. Select OK and a tone sounds signalling that your change has been made.

b. Feature Set Up: (Temp and Printer) Selecting this button allows you to turn the Temp parameter and printer on or off by using the rotor to select the option. Once you have made your selection, a small check mark

9 appears next to the box that


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Calibration & Maintenance contains both a

9

and an “x.” Select OK and a tone sounds signalling that your change has been made.

c. Clear Error Log: Selecting this button clears all errors in the error log and sounds a tone signalling that your change has been made.

4. To exit, power off the Monitor.


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4.10 TROUBLESHOOTING


Trouble

Monitor will not switch on when powered by battery

Unit will not switch on from either battery or external AC source. No AC mains light.

Pressing rotor fails to power on the unit, menu selection is possible

No rotor selection or menu skips

Illegible or no LCD display

No LCD backlight

Incorrect, missing segments, or no LED display output

Battery not charging or not holding charge

Probable Cause

- Battery may be discharged

- PSU board fault

- Locked processor

- PSU Module

Rotor ON/OFF switch

Main board failure

- LCD failure

- Main board fault (usually accompanied by an audible alarm if main board processor has ceased operation)

- Negative supply to LCD (-9.6

Vdc) is out of tolerance

- LCD faulty

- Main board fault

- Main board fault (usually accompanied by an audible alarm if main board processor has ceased operation)

- No or low +4 Vdc LED supply

- Check battery charging function

- PSU PWA

“SpO2 probe disconnected” error displayed on LCD

- Faulty probe

- SpO2 PWA failed

Fault Isolation

- Replace with known, charged battery

- Replace PSU board

- Press and hold ON/OFF button for 15 seconds.

- check PSU module for 24 Vdc

Replace mains PWA

Replace main board

- Replace LCD

- Replace main board

- Check negative supply reaching the

LCD module

- Replace the LCD

- Replace the main board

- Replace LCD

- Replace PSU board

- Check supply continuity from PSU board to Main board

- Input Service code: 8378 after selecting the Service button. Then select PIC. Then select C bat. The Monitor displays the

Battery C value. Multiply Battery C value

(ADU) x .101 = charge volts. If charge volts is less than 13.0 volts, replace PSU

PWA

- Test parameter with known good accessories

- Replace PWA and test unit with Spo2 simulator


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Trouble

Following the monitor powerup sequence, a fail-safe alarm sounds, and one of the following messages appears on the LCD:

System error, P105

System error, P110

System error, P115

Overpressure warnings displayed on LCD when NIBP is initialized (with or without a cuff and hose)

At NIBP Start, the pump sounds labored, generally accompanied by one of the following messages:

N33-NIBP: Inflation Timeout

N00-NIBP: Overpressure

TSH_HW:PIC displayed on the main LCD

Pump Over Current 0, (code line failure), 0, 0

Unit does not respond to host communications

Probable Cause

- Failed SpO2 sensor or cable

- SpO2 PWA faulty

- Occluded air hose or cuff

- Partial or full blockage of internal pneumatic tubing

- Valve assembly faulty

- Reversed connections on pneumatic assembly failure

- Blocked or kinked hose from pump output of the front panel

- Pneumatic assembly failure

Monitor has failed temperature self-calibration

- A pump over-current condition has been signaled to the main board processor

- Pump failure

PSU board unresponsive

Monitor will not retain date/ time

Backup battery low or disconnected

Fault Isolation

- Replace sensor/cable

- Replace SpO2 PWA and reinspect the monitor

- Verify +5 Vdc isolated power supply is within specification

- Replace main board and reinspect the monitor

- Inspect cuff and hose for blockages

- Inspect the pneumatic tubing for routing or kinks

- Replace the pneumatic assembly

- Inspect tubing for correct installation/ routing

- Examine hosing for kinks or blockages

- Inspect pneumatic assembly for blocked output

- Replace pneumatic assembly

Replace main board

- Replace the main board

- Replace pump assembly

- Replace PSU board

- Check continuity of PSU board to the host comm port cable on the rear panel

- Verify backup battery jumper is properly installed

- Replace mains PWA


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4.11 ERROR CODES



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A

Appendix


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A-2 DINAMAP® PRO Series 100-400V2 Monitor Service Manual

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Appendix A

Test Records

Model # __________________ Serial #__________________________________

Step

Description

5.2 Internal Tests

5.2.2.4 Leak rate

≤ 6mmHg / 30sec from 200 mmHg

5.2.2.8 UUT pressure (top) 50 mmHg

5.2.2.8

5.2.2.9

5.2.2.9

UUT pressure (bottom) 50 mmHg

UUT pressure (top) 150 mmHg

UUT pressure (bottom) 150 mmHg

5.2.2.10 UUT pressure (top) 250 mmHg

5.2.2.10 UUT pressure (bottom) 250 mmHg

5.2.2.11 Verify overpressure occurs below 330mmHg

5.3.1 SPO

2

test

Min

244

244

Max

46 54

46 54

145 155

145 155

255

255

Actual Pass Fail N/A

5.3.1.4 SP0

2

reading at 100 % saturation

5.3.1.5 SP0

2


5.3.1.6 SP0

2


5.5.1.7 Verify alarm sounds and displays below 90%

5.3.2 BPM test

5.3.2.1 Verify low rate alarm at 50 BPM

5.3.2.2 Heart Rate reading at 50 BPM (SPO

2


2

) 116


2

5.3.3 NIBP test

5.3.3.4

5.3.3.5

5.3.3.6

5.3.3.7

Initial cuff inflation (Adult)

Systolic reading (120/80 Adult)

Diastolic reading (120/80 Adult)

Heart rate reading at 80 BPM (NIBP)

5.3.3.8 Inflate / deflate cycle time <120 sec

5.3.3.12 Initial cuff inflation (Neonate)

5.3.3.13 Systolic reading (100/65 Neonate)

5.3.3.14 Diastolic reading (100/65 Neonate)

5.3.4 Temperature Test

5.3.4.3 Measured temperature in

°F (98.6 nominal)

96 100

86 94

76 84

143 1771

107 133

67

76

93

84

94 151

87 123

52 78

98.4 98.8


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Appendix A

Step

Description


°F (80.2 nominal)


°F (107.8 nominal)

5.3.4.10 Broken Probe fault condition

5.4 Pushbutton test

5.4.1.1 Verify appropriate responses to pushbuttons

5.4.2 Sound test

5.4.2.2 Verify volume levels

5.4.3 Printer test

5.4.3.2 Printer produces a clear printout

5.4.4 Battery System test

5.4.4.1

5.4.4.4

5.4.4.5

Verify AC mains indicator

Verify uninterrupted battery operation

Verify battery indicator

5.4.5. Remote Alarm

5.4.5.2 Voltage between pins 4 and 8, alarm inactive

5.4.5.4 Voltage between pins 4 and 8, alarm active

5.4.6 Communications test

5.4.6.2 Verify pump starts, stops and temp. status returns

6.0

6.1

Hipot Tests

AC Main Hipot

6.3 SP02 Hipot

7.0 Safety Tests

7.2.7 EXTDC to GND Resistance (m

Ω)

7.3.6 SPO2 leakage (uA) (models 300 and 400)

7.4.6 Temp leakage (uA) (models 200 and 400)

7.5.4.1 Normal no-fault leakage (uA)

7.5.4.3 Normal open-ground leakage (uA)

7.5.4.6 Normal open-neutral leakage (uA)

7.5.5.1 Reverse no-fault leakage (uA)

7.5.5.3 Reverse open-ground leakage (uA)

7.5.5.6 Reverse open-neutral leakage (uA)

Min Max Actual Pass Fail N/A

79.9 80.5

107.5 108.1

4.7 5.3

0.0 0.1

0 1000

0

0

0

0

0

0

0

0

150

50

500

500

500

500

500

500

Tested By: ______________________________________ Date: ___________

A-4 DINAMAP® PRO Series 100-400V2 Monitor Service Manual

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Appendix B

B

Appendix


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Appendix B

B-2 DINAMAP® PRO Series 100-400V2 Monitor Service Manual

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Appendix B

Field Replaceable Parts

FRU IDENTIFICATION TABLE

The following table offers details of each of the corresponding bubble numbers that appear on the FRU assembly drawings. For any item numbers that do not have a FRU number associated with it, please call Customer Service to order this part.

27

28

29

30

31

32

33

21

22

23

24

25

26

BUBBLE

#

3

4

1

2

45

46

50

51

55

12

13

14

15

17

18

19

7

8

9

5

6

10

11

20

38

39

41

ITEM DESCRIPTION

PLASTIC FRONT CASE, DP210/410 (W/ TEMP)

ROTOR KNOB (T1310 M01)

ROTOR SHAFT, DINAMAP PRO (T1304 M01)

POLE CLAMP, DINAMAP PRO (T1313 M02)

SCREW, POLE CLAMP, MOLDED (T1313 M01)

KNOB, POLE CLAMP (T1310 M02)

SCREW, SELF TAP, TORX, ZINC

INSULATOR, NOMEX, DINAMAP PRO

CLIP , RETAINING

SCREW, SELF TAP, TORX, BLACK

WASHER, 2.5MM X 8MM X 0.5MM THICK

ASSY ,MAIN PWA, MIDWAY, V2

ASSY NELLCOR BUNDLED MP506

LCD MODULE ASSY, DINAMAP PRO

PLASTIC FRONT CASE, DP110/310 (W/O TEMP)

SCREW, M2.5 X 16 CSK POZI, SST, DIN965A

ASSY , PNEUMATIC, SINGLE X-VALVE,12V

BRACKET, PUMP NIBP

PLUG , SPO2 BLANKING FOR DP110/210

PLUG, BLANK, TEMP DINAMAP PRO (T1335 M01)

SPACER PCB STAND OFF

FASTENER, WIRE SADDLE, TOP ENTRY

CONN , SNAP-IN, MAINS POWER

PWA, PSU, DINAMAP PRO

PLUG, BLANKING, DC JACK (T1335 M03)

FILTER 40 MICRON

TUBING SLICONE 1/8ID X 1/4OD

GASKET,BATTERY SUPPORT,ADHESIVE

GASKET, RS-232

GASKET,BATTERY SUPPORT TO PSU

ASSY , VALVE, 12 VOLT, 3-WAY, NC

CABLE ASSY, DUMP VALVE, PRO SERIES, V2

FRU # FRU DESCRIPTION

2012405-001 PLASTIC FRONT CASE W/TEMP DP210/410 FRU

2012414-001 KIT ,ROTOR KNOB DP110-410 FRU


2012409-001 KIT ,KNOB & POLE CLAMP DP110-410 FRU

2012407-001 &

2012409-001

KIT ,HARDWARE & FASTENERS DP110-410 FRU KIT

,KNOB & POLE CLAMP DP110-410 FRU

2012409-001 KIT ,KNOB & POLE CLAMP DP110-410 FRU

2012415-001 KIT ,TEMPERATURE DP210/410 FRU

2012416-001 KIT ,LCD MODULE ASSY DP110-410 FRU

2012407-001 KIT ,HARDWARE & FASTENERS DP110-410 FRU

2012407-001 & KIT ,HARDWARE & FASTENERS DP110-410 FRU KIT

2012417-001 ,SPEAKER ASSY DP110-410 FRU


ASSY ,PWA MAIN BOARD, DP110 FRU ASSY, PWA MAIN

2012402-001 &

2012565-001

2012399-001

BOARD, DP210 FRU ASSY ,PWA MAIN BOARD, DP310

FRU ASSY , PWA MAIN BOARD DP410 FRU

KIT ,NELLCOR SPO2 DP210N/410N FRU

2012416-001 KIT ,LCD MODULE ASSY DP110-410 FRU

2012406-001 PLASTIC FRONTCASE W/O TEMP DP110/310 FRU

2012399-001 KIT ,NELLCOR SPO2 DP210N/410N FRU

2012412-001 KIT ,PNEUMATIC ASSY W/VALV DP110-410 FRU none

2012405-001 &

2012406-001

PLASTIC FRONT CASE W/TEMP DP210/410 FRU PLASTIC

FRONTCASE W/O TEMP DP110/310 FRU

2012405-001 &

2012406-001



2012399-001 KIT ,NELLCOR SPO2 DP210N/410N FRU


2012404-001 KIT ,REARCASE,LABELS&ACCONN DP110-410FRU

2012401-001 ASSY ,PWA PSU DP110-410 FRU


2012412-001 KIT ,PNEUMATIC ASSY W/VALV DP110-410 FRU


2012408-001 KIT ,BATTERY COMPARTMENT DP110-410 FRU

2012401-001 ASSY ,PWA PSU DP110-410 FRU

2012408-001 KIT ,BATTERY COMPARTMENT DP110-410 FRU



2012404-001 &

2012409-001

2012404-001

KIT ,REARCASE,LABELS&ACCONN DP110-410FRU KIT


KIT ,REARCASE,LABELS&ACCONN DP110-410FRU

TAPE, FOAM, SGL SIDED ADHESIVE, 25X.125THK

TAPE, FOAM, SGL SIDED ADHESIVE, 2W X 1/16THK

SPRING, SST, .187 OD, .163 ID, .012 WIRE, .525 L, RATE

= .600LBS/IN

SPACER, PUSH MOUNT

LABEL ,SERIAL NUM,DINAMAP PRO 110-410 V2

LABEL , BLANK COVER, PRO 100 SERIES

LABEL ,ALARIS TURBO TEMP, BLUE

LOCKNUT, M2.5 DIN 985


2012407-001 & KIT ,HARDWARE & FASTENERS DP110-410 FRU KIT

2012414-001 ,KNOB & POLE CLAMP DP110-410 FRU


NO FRU

2012405-001 PLASTIC FRONT CASE W/TEMP DP210/410 FRU



2018553-001

B-3

Appendix B

BUBBLE

#

70

115

116

117

118

119

120

121

122

130

110

111

112

113

114

101

102

103

104

105

106

107

108

109

ITEM DESCRIPTION

SCREW, SELF TAP POSIDRIVE #8X0.5IN

LABEL ,FASCIA, PRO 410 US

LABEL ,FASCIA, PRO 410 UK

LABEL , FASCIA, PRO 410 FR

LABEL , FASCIA, PRO 410 GE

LABEL , FASCIA, PRO 410 SP

LABEL , FASCIA, PRO 410 RW

LABEL , FASCIA, PRO 310 US

LABEL , FASCIA, PRO 310 UK





LABEL , FASCIA, PRO 210 US & UK





LABEL , FASCIA, PRO 110 US & UK





FT,RND,12.7 DIA X 3.5H SELF ADHSV

135

136

210

211

212

213

220

222

LIGHT DIFFUSER, DINAMAP PRO (T1307 M01)

ACTUATOR, SWITCH, MOLD (T1307 M02)

PRINTER MODULE ASSY, DINAMAP PRO

LABEL, BATTERY REPLACEMENT

WINDOW, FRONT PANEL LCD DISPLAY

PWA SPO2, MASIMO MS-5, 9600 BAUD

LABEL, ADH PROCARE NELLCOR OXIMAX

SPACER PCB, 7/16, NYLON SNAP-IN

230

290

310

312

313

314

315

317

320

321

330

350

370

380

390

LABEL, ADH PROCARE MASIMO SET

LABEL ,PATENT, SIDE CASE, PRO SERIES

REAR CASE, MOLDING, DINAMAP PRO (T1308)

BATTERY DOOR, DINAMAP PRO (T1312 M01)

BATTERY SUPPORT, DINAMAP PRO (T1311 M02)

SPEAKER ASSY, DINAMAP PRO

SPEAKER CLAMP RING

PSU MODULE (OEM 24V), DINAMAP PRO

SENSOR TEMP OMRON EE-SX4235A-P2

GROMMET, ISODAMP, RUBBER

CABLE ASSY TEMP PROBE SENSOR CABLE ASSY

BRACKET ,OPTICAL TEMPERATURE SWITCH

MOULDING, PAD, POLE CLAMP (T1314)

WASHER, 18 ID, 25 OD, 1.5THK, FLAT SST

CIRCLIP, .625 SHAFT, .485 GROOVE 'E'

FRU #

2012407-001

2012406-001

2012405-001 &

2012406-001

2012411-001

2012404-001

2012405-001

2012400-001

2012405-001

2012400-001

2012400-001,

2012405-001,

2012406-001

2012404-001

2012404-001

2012408-001

2012408-001

2012417-001

2012417-001

2012413-001

2012415-001

NO FRU

2012415-001

2012415-001

2012404-001

2012404-001 &

2012409-001

2012407-001 &

2012409-001

2012419-001

2012424-001

2012420-001

2012421-001

2012423-001

2012425-001

2012435-001

2012439-001

2012436-001

2012438-001

2012437-001

2012440-001

2012441-001

2012442-001

2012444-001

2012445-001

2012446-001

2012447-001

2012448-001

2012449-001

2012450-001

2012451-001

2012404-001

2012405-001 &

FRU DESCRIPTION

KIT ,HARDWARE & FASTENERS DP110-410 FRU

KIT , FASCIA ENGLISH DP410 FRU

KIT , FASCIA UK DP410 FRU

KIT , FASCIA FRENCH DP410 FRU

KIT , FASCIA GERMAN DP410 FRU

KIT , FASCIA SPANISH DP410 FRU

KIT , FASCIA ROW DP410 FRU


KIT , FASCIA UK DP310 FRU




















KIT , PRINTER DP110-410 FRU


PLASTIC FRONT CASE W/TEMP DP210/410 FRU

ASSY,MASIMO SP02 BOARD DP310M/410M FRU

PLASTIC FRONT CASE W/TEMP DP210/410 FRU

ASSY,MASIMO SP02 BOARD DP310M/410M FRU

ASSY,MASIMO SP02 BOARD DP310M/410M FRU PLASTIC

FRONT CASE W/TEMP DP210/410 FRU PLASTIC




KIT ,BATTERY COMPARTMENT DP110-410 FRU

KIT ,BATTERY COMPARTMENT DP110-410 FRU

KIT ,SPEAKER ASSY DP110-410 FRU

KIT ,SPEAKER ASSY DP110-410 FRU

KIT ,PSU MODULE DP110-410 FRU

KIT ,TEMPERATURE DP210/410 FRU




KIT ,REARCASE,LABELS&ACCONN DP110-410FRU KIT


KIT ,HARDWARE & FASTENERS DP110-410 FRU KIT


B-4 DINAMAP® PRO Series 100-400V2 Monitor Service Manual

2018553-001

Revision B

2020796 A PRO Series 100-400V2

FRUs Assembly Sheet 1

2020796 A PRO Series 100-400V2


2020796 A PRO Series 100-400V2


2020796 A PRO Series 100-400V2


2020796 A PRO Series 100-400V2


2020796 A PRO Series 100-400V2


A

Appendix C –

Electromagnetic

Compatibility

Revision B DINAMAP® PRO Series 100-400V2 Monitor

2018553-001

C-1

C-2 DINAMAP® PRO Series 100-400V2 Monitor

2018553-001

Revision B

Appendix C – Electromagnetic Compatibility: Electromagnetic Compatibility (EMC): PRO Series 100-400 Monitor

Electromagnetic Compatibility (EMC):

PRO Series 100-400 Monitor

Changes or modifications to this system not expressly approved by GE

Medical Systems can cause EMC issues with this or other equipment.

This system is designed and tested to comply with applicable regulation regarding EMC and must be installed and put into service according to the EMC information stated in this appendix.

WARNING

Use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation.

WARNING

The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used.

Guidance and Manufacturer’s Declaration – Electromagnetic

Emissions

The DINAMAP® PRO Series 100-400V2 Monitor is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to assure that the DINAMAP® PRO Series 100-

400V2 Monitor is used in such an environment.

Emissions Test

RF Emissions

EN 55011

Compliance

Group 1

Electromagnetic Environment – Guidance

The equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions

EN 55011

Harmonic Emissions

EN 61000-3-2

Class A

Class A The equipment is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/

Flicker Emissions

EN 61000-3-3

Complies


2018553-001

C-3



Immunity



Immunity Test

Electrostatic

Discharge (ESD)

EN 61000-4-2

Electrical Fast

Transient/Burst

EN 61000-4-4

Surge

EN 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

EN 61000-4-11

Power Frequency

(50/60 Hz)

Magnetic Field

EN 61000-4-8

EN 60601 Test Level

± 6 kV contact

± 8 kV air

Compliance Level

± 6 kV contact

± 8 kV air


Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power should be that of a typical commercial or hospital environment.

± 2 kV for power supply lines ± 2 kV for power supply lines

±1 kV for input/output lines ±1 kV for input/output lines

± 1 kV differential mode

± 2 kV common mode

<5% U t

(>95% dip in U t for 0.5 cycles for 25 cycles

)

<40% U t

(>60% dip in U for 5 cycles t

)

<70% U t

(>30% dip in U t

)

± 1 kV differential mode

± 2 kV common mode

<5% U t

(>95% dip in U t

) for 0.5 cycles

<40% U

U t

<70% U

U t t

(>60% dip in

) for 5 cycles t

(>30% dip in

) for 25 cycles


Mains power should be that of a typical commercial or hospital environment. If the user of the equipment requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterruptible power supply or a battery.

<5% U t for 5 s

(>95% dip in U t

)

3 A/m

<5% U t

(>95% dip in U t

) for 5 s

3 A/m Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

NOTE:

U t

is the AC mains voltage prior to application of the test level.


2018553-001

Revision B



Immunity



Immunity Test

Conducted RF

EN 61000-4-6

Radiated RF

EN 61000-4-3


3 Vrms

150 KHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

Compliance Level Electromagnetic Environment – Guidance

Portable and mobile RF communications equipment should not be used closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

3 V rms

d = 1.2

P

3 V/m

d = 1.2

P 80 MHz to 800 MHz

d = 2.3

P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a , should be less than the compliance level in each frequency range b .

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio,

AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment.

b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.


2018553-001

C-5


Recommended Separation Distances

The table below provides the recommended separation distances (in meters) between portable and mobile RF communications equipment and the DINAMAP® PRO Series 100-400V2 Monitor.

The DINAMAP® PRO Series 100-400V2 Monitor is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled. The customer or the user of the DINAMAP® PRO Series 100-

400V2 Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DINAMAP® PRO

Series 100-400V2 Monitor as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output

Power of Transmitter in

Watts

0.01

0.1

1

10

100

Separation Distance in Meters (m) According to Frequency of Transmitter

150 kHz to 80 MHz a

80 MHz to 800 MHz a

800 MHz to 2.5 GHz a

d = 1.2

0.12

P

0.38

1.2

3.8

12

d = 1.2

0.12

P

0.38

1.2

3.8

12 a At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

d = 2.3

0.23

P

0.73

2.3

7.3

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance [d] in meters (m) can be estimated using the equitation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts

(W) according to the transmitter manufacturer.

NOTE:

These guidelines may not apply in all instances. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.


2018553-001

Revision B


Compliant Cables and Accessories

WARNING

The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system.

The table below lists cables, transducers, and other applicable accessories with which GE Medical Systems claims EMC compliance.

NOTE: Any supplied accessories that do not affect EMC compliance are not included.

Part No

Temperature Cables and Probes

2008774-001

2008775-001

088012

088016

Pulse Oximetry Cables and Sensors

407705-006

2008773-001

2009743-001

2009745-001

Accessories

Description

TurboTemp Oral Probe, Blue

TurboTemp Rectal Probe, Red

Temp Oral Probe, Blue

Temp Rectal Probe, Red

Nellcor DuraSensor Reusable Finger Probe

(DS100A)

Nellcor Interface Cable, OxiSmart, DOC10 Cable

Masimo PC08 Cable

Masimo Finger Sensor, Adult, Reusable

N/A

316579-001

ILC 1926

RJ45 series Category 5 cable

AC cable, Hospital Grade, AHA,

Isolated Level Converter

Maximum Lengths

3.0m / 10 ft

3.6 m / 12 ft

3.0m / 10 ft

3.6 m / 12 ft

0.9 m / 3 ft

3.3 m / 11 ft

2.5 m / 8.2 ft

N/A

N/A

3.6 m / 12 ft

N/A


2018553-001

C-7

Appendix C – Electromagnetic Compatibility: Electromagnetic Compatibility (EMC): ILC-1926

Electromagnetic Compatibility (EMC): ILC-1926




WARNING


WARNING



Emissions

The ILC-1926 is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to assure that the ILC-1926 is used in such an environment.

Emissions Test

RF Emissions

EN 55011

Compliance

Group 1



RF Emissions

EN 55011

Harmonic Emissions

EN 61000-3-2

Class B

Not Applicable The equipment is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.


Flicker Emissions

EN 61000-3-3

Complies


2018553-001

Revision B



Immunity


Immunity Test

Electrostatic

Discharge (ESD)

EN 61000-4-2

Electrical Fast

Transient/Burst

EN 61000-4-4

Surge

EN 61000-4-5


EN 61000-4-11

Power Frequency

(50/60 Hz)

Magnetic Field

EN 61000-4-8


± 6 kV contact

± 8 kV air

<5% U t for 5 s

(>95% dip in U t

)

3 A/m


± 6 kV contact

± 8 kV air



No AC Input ± 2 kV for power supply lines No AC Input

±1 kV for input/output lines

No AC Input ± 1 kV differential mode

± 2 kV common mode

<5% U t

(>95% dip in U t

) for 0.5 cycles

<40% U t


)

<70% U t

(>30% dip in U t

) for 25 cycles


<5% U t

(>95% dip in U t

) for 0.5 cycles

<40% U

U t

<70% U

U t t

(>60% dip in

) for 5 cycles t

(>30% dip in

) for 25 cycles

Mains power should be that of a typical commercial or hospital environment. If the user of the DINAMAP

ILC-1926 requires continued operation during power mains interruptions, it is recommended that the Host monitor be powered from an uninterruptible power supply or a battery.

<5% U t

(>95% dip in U t

) for 5 s


NOTE:

U t



2018553-001

C-9



Immunity


Immunity Test

Conducted RF

EN 61000-4-6

Radiated RF

EN 61000-4-3


3 Vrms

150 KHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz




3 V rms

d = 1.2

P

3 V/m

d = 1.2

P 80 MHz to 800 MHz

d = 2.3










2018553-001

Revision B



The table below provides the recommended separation distances (in meters) between portable and mobile RF communications equipment and the ILC-1926.

The ILC-1926 is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled. The customer or the user of the ILC-1926 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ILC-1926 as recommended below, according to the maximum output power of the communications equipment.



Watts

0.01

0.1

1

10

100


150 kHz to 80 MHz a

80 MHz to 800 MHz a

800 MHz to 2.5 GHz a

d = 1.2

0.12

P

0.38

1.2

3.8

12

d = 1.2

0.12

P

0.38

1.2

3.8


d = 2.3

0.23

P

0.73

2.3

7.3

23



NOTE:



2018553-001

C-11



WARNING


Part No

Accessories

N/A

683235

683236

683242



Description Maximum Lengths

RJ45 series Category 5 cable

Adapter Cable, RJ45 to DB15.

Adapter Cable, RJ45 to DB25

Adapter Cable, RJ45 to DB9.

N/A

600 mm / 2 ft

460 mm / 18 in

3.0 m / 10 ft


2018553-001

Revision B


Electromagnetic Compatibility (EMC): ILC-1931




WARNING


WARNING



Emissions


Emissions Test

RF Emissions

EN 55011

Compliance

Group 1



RF Emissions

EN 55011

Harmonic Emissions

EN 61000-3-2

Class A

Not Applicable The equipment is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.


Flicker Emissions

EN 61000-3-3

Not Applicable


2018553-001

C-13



Immunity


Immunity Test

Electrostatic

Discharge (ESD)

EN 61000-4-2

Electrical Fast

Transient/Burst

EN 61000-4-4

Surge

EN 61000-4-5


EN 61000-4-11

Power Frequency

(50/60 Hz)

Magnetic Field

EN 61000-4-8


± 6 kV contact

± 8 kV air

<5% U t for 5 s

(>95% dip in U t

)

3 A/m


± 6 kV contact

± 8 kV air



No AC Input ± 2 kV for power supply lines N/A

±1 kV for input/output lines

N/A ± 1 kV differential mode

± 2 kV common mode

<5% U t

(>95% dip in U t

) for 0.5 cycles

<40% U t


)

<70% U t

(>30% dip in U t

) for 25 cycles

No AC Input

<5% U t

(>95% dip in U t

) for 0.5 cycles

<40% U

U t

<70% U

U t t

(>60% dip in

) for 5 cycles t

(>30% dip in

) for 25 cycles

Mains power should be that of a typical commercial or hospital environment. If the user of the ILC-1931 requires continued operation during power mains interruptions, it is recommended that the Host monitor be powered from an uninterruptible power supply or a battery.

<5% U t

(>95% dip in U t

) for 5 s


NOTE:

U t



2018553-001

Revision B



Immunity


Immunity Test

Conducted RF

EN 61000-4-6

Radiated RF

EN 61000-4-3


3 Vrms

150 KHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz




3 V rms

d = 1.2

P

3 V/m

d = 1.2

P 80 MHz to 800 MHz

d = 2.3










2018553-001

C-15



The table below provides the recommended separation distances (in meters) between portable and mobile RF communications equipment and the ILC-1931.

The ILC-1931 is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled. The customer or the user of the ILC-1931 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ILC-1931 as recommended below, according to the maximum output power of the communications equipment.



Watts

0.01

0.1

1

10

100


150 kHz to 80 MHz a

80 MHz to 800 MHz a

800 MHz to 2.5 GHz a

d = 1.2

0.12

P

0.38

1.2

3.8

12

d = 1.2

0.12

P

0.38

1.2

3.8


d = 2.3

0.23

P

0.73

2.3

7.3

23



NOTE:



2018553-001

Revision B



WARNING


Part No

Accessories

683235

418497-002



Description Maximum Lengths

Adapter Cable, RJ45 to DB15

Apex Pro Cable

600 mm / 2 ft

1.8m / 6 ft


2018553-001

C-17



2018553-001

Revision B

gemedical.com

World Headquarters

GE Medical Systems

Information Technologies, Inc.



Tel: +414.355.5000

800.558.5120 (US only)

Fax: +414.355.3790

European Representative

GE Medical Systems

Information Technologies GmbH

Munzinger Straße 3-5

D-79111 Freiburg

Germany

Tel: + 49 761 45 43 - 0

Fax: + 49 761 45 43 - 233

0086

2018553-001 B

Asia Headquarters

GE Medical Systems

Information Technologies Asia; GE (China) Co., Ltd.

24th Floor, Shanghai MAXDO Center,

8 Xing Yi Road, Hong Qiao Development Zone

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GE Medical Systems PRO 100, PRO 200, PRO 300, PRO 400 Blood Pressure Monitor Service Manual

Assistant Bot

PRO Series 100 - 400 V2

Service Manual

DINAMAP

®

PRO Series 100-400V2

Monitor Service Manual

.

2018553-001 Revision B

DINAMAP

Series PRO 100-400V2 Monitor

Service Manual

TABLE OF CONTENTS

Section 1. INTRODUCTION

Section 2. PRODUCT DESCRIPTION

Section 3. THEORY OF OPERATION

Section 4. GENERAL MAINTENANCE

Appendix A: Test Records

Appendix B: Field Replaceable Parts and Assembly

Drawings

Appendix C: Electromagnetic Compatibility

Introduction

Section 1. INTRODUCTION

1.1 SCOPE OF MANUAL

1.2 ADDENDA

1.3 TRADEMARKS AND TRADE NAMES

1.4 SERVICE POLICY

1.5 EXTENDED WARRANTIES

1.6 ASSISTANCE

1.7 SERVICE

1.8 INSTALLATION AND OPERATION

1.9 WARNINGS AND PRECAUTIONS

1.10 DISPOSAL OF PRODUCT WASTE

1.11 SYMBOL DEFINITIONS

IPX1

1.12 GLOSSARY OF TERMS AND ABBREVIATIONS

Product Description

SECTION 2. PRODUCT DESCRIPTION

2.1 INTRODUCTION

2.2 PRODUCT CONFIGURATIONS

2.3 CONTROLS, INDICATORS, AND CONNECTORS

2.4 HOST PORT CONNECTOR (REAR PANEL)

2.5 REORDER PART NUMBERS

2.6 SPECIFICATIONS

IPX1

≤

≤

Theory of Operation

3.1 INTRODUCTION

3.2 OVERALL PRINCIPLES OF OPERATION

3.3 FUNCTIONAL DESCRIPTION

Calibration &

Maintenance

SECTION 4. GENERAL MAINTENANCE

4.1 INTRODUCTION

4.2 FUSES

4.3 PERIODIC MAINTENANCE

4.4 Clinician Mode

4.5 SERVICE MODE

4.6 PRE-SERVICE TEST PROCEDURES

4.7 PRO MONITOR CALIBRATION PROCEDURES

4.8 ELECTRICAL SYSTEM SAFETY CHECKS

4.9 FEATURES SELECTION

4.10 TROUBLESHOOTING

Trouble

Probable Cause

Fault Isolation

Trouble

Probable Cause

Fault Isolation

4.11 ERROR CODES

Appendix

Test Records

Model # __________________ Serial #__________________________________

Description

5.2 Internal Tests

5.3.1 SPO

test

Min

Model # Serial #________________

Tested By: ____________________________ Date: _