Veris 8600 Service Manual Rev 0 Sept 2005 PDF download

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

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Veris 8600 Patient Monitoring System TM

Service Manual

p/n 3010798 Revision 0 Date 09/05

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Serial Numbers and date of installation must be supplied when ordering replacement parts or inquiring about service. For convenience, record the following information below:

OWNER: DATE INSTALLED: SYSTEM SERIAL NUMBER: MONITOR SERIAL NUMBER: BASE SERIAL NUMBER: POWER SUPPLY SERIAL NUMBER:

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

ECG MODULE SERIAL NUMBER: REMOTE DISPLAY SERIAL NUMBER: The information and specifications included in this publication were in effect at the time of approval for printing. MEDRAD, Inc., reserves the right, however, to discontinue or otherwise change specifications or design at anytime without notice and without incurring any obligation whatsoever.

Page ii

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Contents Contents................................................................................................................ iii

Section 1 Introduction Copyright Notice................................................................................................. 1-1 Trademarks ........................................................................................................ 1-1 Restricted Sale................................................................................................... 1-1 In Case of Emergency Contact .......................................................................... 1-1 CE Contact ................................................................................................... 1-1 MEDRAD Subsidiaries.................................................................................. 1-1 International Offices...................................................................................... 1-2 Applicability ........................................................................................................ 1-3 Purpose.............................................................................................................. 1-3 Important Safety Notice...................................................................................... 1-3 Intended Use...................................................................................................... 1-3 Certifications ...................................................................................................... 1-3 Medrad Service - Additional Information Regarding Compliance to IEC 60601-1-2 / 2001 2nd Edition ......................................................................................................... 1-4 Symbols and Descriptions.................................................................................. 1-7 Regulatory Symbols...................................................................................... 1-7 Safety Symbols............................................................................................. 1-7 System Symbols ........................................................................................... 1-8 Port Symbols ................................................................................................ 1-8 Miscellaneous Symbols ................................................................................ 1-9 Definition of Warnings and Cautions................................................................ 1-10 Warnings .......................................................................................................... 1-10 Cautions ........................................................................................................... 1-12 Leakage Current ......................................................................................... 1-13 Voltage Fluctuations ................................................................................... 1-13 Equipotential Ground .................................................................................. 1-13 Software Version ........................................................................................ 1-14 Software Error Related Hazard Mediation .................................................. 1-14 Potential Interference.................................................................................. 1-14 Biocompatibility........................................................................................... 1-15 Probes Fall in Fluids ................................................................................... 1-15 FCC and Industry Canada Compliance ...................................................... 1-15 Audible Pulse Tone..................................................................................... 1-15 Accessory Disposal .................................................................................... 1-15 Latex Content ............................................................................................. 1-15

Section 2 Main Monitor Maintenance and Checkout Incoming Inspection ........................................................................................... 2-1 Maintenance Schedule....................................................................................... 2-1 Monitor Safety Testing ....................................................................................... 2-2 Equipment and Tools.................................................................................... 2-2 Accessory Testing ........................................................................................ 2-2 Cleaning and Disinfecting .................................................................................. 2-3 Accidental Wetting ............................................................................................. 2-3 Battery Safety..................................................................................................... 2-4 Long-Term Monitor and Battery Storage............................................................ 2-4 Monitor and Accessories Disposal ..................................................................... 2-4 Fuse Replacement ............................................................................................. 2-4 Electrical Safety Testing (Main Monitor) ............................................................ 2-5 Leakage Test Equipment and Setup ............................................................ 2-5 Leakage Test Procedure .............................................................................. 2-5 Functional Testing.............................................................................................. 2-6

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Medrad Veris 8600

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Interface Inspection....................................................................................... 2-6 Manual Controls Check................................................................................. 2-6 Fiber Optic Communication........................................................................... 2-7 Alarms Verification ........................................................................................ 2-8 Module Verification ............................................................................................. 2-9 NIBP Verification ........................................................................................... 2-9 SpO2 Verification ........................................................................................ 2-10 Smart Sat Procedure................................................................................... 2-11 SpO2 Gating Verification .............................................................................2-11 ECG Verification.......................................................................................... 2-12 ECG Gating Verification .............................................................................. 2-14 IBP Verification............................................................................................ 2-14 Temperature Verification.............................................................................2-15 Anesthesia/CO2/O2 Verification .................................................................. 2-15 Electrical Safety Testing (Power Supply) ......................................................... 2-16 Verification of Fuses and Assembly ............................................................ 2-16 Leakage Test Equipment and Setup........................................................... 2-16 Leakage Test Procedure.............................................................................2-16 Output Verification....................................................................................... 2-17 ECG Module Verification .................................................................................. 2-18 Equipment Needed ..................................................................................... 2-18 Verification of ECG Module Charger........................................................... 2-18 Risk Current Testing ................................................................................... 2-18 ECG Display Testing................................................................................... 2-18 ECG Lead-Off Testing................................................................................. 2-19

Section 3 Main Monitor Troubleshooting Troubleshooting and Repair ............................................................................... 3-3 Main Board ......................................................................................................... 3-3 Power Supply ..................................................................................................... 3-4 Fuse Replacement ............................................................................................. 3-4

Section 4 Main Monitor Theory of Operation Power Module..................................................................................................... 4-1 Main CPU and System ....................................................................................... 4-1 Vital Signs Module ........................................................................................ 4-1 Speaker Driver .............................................................................................. 4-1 ECG Module ....................................................................................................... 4-2 Pulse Oximeter Module (SpO2) .......................................................................... 4-2 Capnometer Module (CO2)................................................................................. 4-2 Galvanic Oxygen Sub-Module (O2) .................................................................... 4-3 Temperature ....................................................................................................... 4-4 Communications................................................................................................. 4-5 Gating ................................................................................................................. 4-5 Printer ................................................................................................................. 4-5 Block Diagram .................................................................................................... 4-6

Section 5 Main Monitor Disassembly Before You Begin ............................................................................................... 5-1 Tools Needed................................................................................................ 5-1 Supplies Needed........................................................................................... 5-1 Precautions ................................................................................................... 5-1 Service Safety ............................................................................................... 5-2 Electrostatic Discharge Protection ................................................................ 5-2 Front Housing Removal...................................................................................... 5-3

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Contents

Front Housing Disassembly ............................................................................... 5-7 Rotary Encoder Knob Removal and Replacement ....................................... 5-7 Membrane Keypad Removal and Replacement ........................................... 5-8 Water Trap Manifold Removal/Replacement................................................ 5-9 Inverter Board Removal and Replacement................................................. 5-10 Display Screen Removal and Replacement ............................................... 5-11 Replacing Printed Circuit Boards (PCBs)......................................................... 5-14 IBP Board ................................................................................................... 5-14 Temperature Module/Board........................................................................ 5-15 ECG Gating Board...................................................................................... 5-16 Vital Signs Module (VSM) Board ................................................................ 5-17 Replacing the Post ........................................................................................... 5-18 Base Disassembly............................................................................................ 5-20 Replacing the Batteries............................................................................... 5-21 Replacing the NIBP Chassis Assembly: ..................................................... 5-22 Replacing the Charger PCB ....................................................................... 5-23 Replacing the O2 Sensor (on Anesthetic Units).......................................... 5-24 Replacing the CO2 Absorber (on Anesthetic Units).................................... 5-25 Replacing the Agent Bench (on Anesthetic Units)...................................... 5-25 Safety Tests ..................................................................................................... 5-25 Servicing the ECG Module............................................................................... 5-26 Servicing the Power Supply ............................................................................. 5-26

Section 6 Main Monitor BOMs and Drawings List of Drawings.................................................................................................. 6-1 Assembly BOMs and Drawings .................................................................... 6-1 Monitor Final Assemblies ................................................................................... 6-2 Base Monitor................................................................................................. 6-2 BasePlus Monitor.......................................................................................... 6-2 Cardiac Monitor ............................................................................................ 6-2 Cardiac with Temperature Monitor ............................................................... 6-2 Anesthetic Monitor ........................................................................................ 6-3 Anesthetic with Temperature Monitor ........................................................... 6-3 Base Assemblies................................................................................................ 6-4 Base Assembly without Gas ......................................................................... 6-4 Base Assembly with Gas .............................................................................. 6-4 Main Top Assemblies......................................................................................... 6-5 Base.............................................................................................................. 6-5 BasePlus....................................................................................................... 6-5 Cardiac ......................................................................................................... 6-6 Cardiac with Temperature ............................................................................ 6-6 Anesthesia .................................................................................................... 6-7 Anesthesia with Temperature ....................................................................... 6-7 Monitor Final Assembly (3010947) .................................................................... 6-9 Base Assemblies.............................................................................................. 6-10 Base Assembly--No Gas (3010982) ........................................................... 6-10 Base Assembly--With Gas (3010672) ........................................................ 6-11 Main Top Assembly.......................................................................................... 6-12 Base (3010977) .......................................................................................... 6-12 BasePlus (3010978) ................................................................................... 6-14 Cardiac (3010979) ...................................................................................... 6-16 Cardiac With Temperature (3010980) ........................................................ 6-18 Anesthesia (3010981)................................................................................. 6-20 Anesthesia with Temperature (3010946).................................................... 6-22

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Medrad Veris 8600

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Section 7 Remote Display Maintenance and Checkout Incoming Inspection............................................................................................ 7-1 Maintenance Schedule ....................................................................................... 7-1 Every 3 Months ............................................................................................. 7-1 Every Year .................................................................................................... 7-1 Monitor Safety Testing........................................................................................ 7-1 Equipment and Tools .................................................................................... 7-2 Accessory Testing......................................................................................... 7-2 Cleaning and Disinfecting................................................................................... 7-3 Accidental Wetting.............................................................................................. 7-3 Fuse Removal and Replacement ....................................................................... 7-4 Long-Term Monitor Storage ............................................................................... 7-5 Monitor and Accessories Disposal ..................................................................... 7-5 Electrical Safety Testing ..................................................................................... 7-6 Leakage Test Equipment and Setup............................................................. 7-6 Leakage Test Procedure............................................................................... 7-6 Functional Testing .............................................................................................. 7-7 Encoder Verification ...................................................................................... 7-7 Fiber Optic Communication........................................................................... 7-7 Display Performance..................................................................................... 7-7 Interface Performance................................................................................... 7-8 Remote Printer Function ............................................................................... 7-8 External Display Function ............................................................................. 7-8 Visual Inspection ........................................................................................... 7-8 Field Service Testing Safety............................................................................... 7-9 Remote Display Fault Testing .......................................................................... 7-10 Power Supply PCB Test.............................................................................. 7-10 Main Board Testing ..................................................................................... 7-11 Communication Board Testing.................................................................... 7-12

Section 8 Remote Display Troubleshooting Troubleshooting and Repair ............................................................................... 8-3 Main Board ......................................................................................................... 8-3 Communication................................................................................................... 8-3 DPAC Communications Board...................................................................... 8-3 Fuse Replacement ............................................................................................. 8-4 AC Power Components ...................................................................................... 8-4

Section 9 Remote Display Theory of Operation Overview............................................................................................................. 9-1 Communication ............................................................................................. 9-1 Printer Interface............................................................................................. 9-1 Main CPU and System ....................................................................................... 9-2 Speaker Driver .............................................................................................. 9-2 Communications................................................................................................. 9-2 Printer ................................................................................................................. 9-2 Block Diagram .................................................................................................... 9-3

vi

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Contents

Section 10 Remote Display Disassembly Before You Begin ............................................................................................. 10-1 Tools Needed ............................................................................................. 10-1 Supplies Needed ........................................................................................ 10-1 Precautions................................................................................................. 10-1 Service Safety............................................................................................. 10-2 Electrostatic Discharge Protection.............................................................. 10-2 Front Housing Removal ................................................................................... 10-3 Front Housing Disassembly ............................................................................. 10-7 Rotary Encoder Knob Removal and Replacement ..................................... 10-7 Membrane Keypad Removal and Replacement ......................................... 10-8 Display Assembly Removal and Replacement ........................................... 10-9 Inverter PCB Removal and Replacement................................................. 10-10 Display Screen Removal and Replacement ............................................. 10-11 Printer Removal and Replacement ................................................................ 10-13 Rear Housing Disassembly............................................................................ 10-14 Main PCB Removal and Replacement ..................................................... 10-14 Front Chassis Removal ............................................................................ 10-16 Power Supply PCB Removal and Replacement....................................... 10-17 Speaker.......................................................................................................... 10-18

Section 11 Remote Display BOMs and Drawings List of Drawings................................................................................................ 11-1 Assembly BOMs and Drawings 1 Remote Monitor Final Assembly ...................................................................... 11-2 Front Housing Assembly .................................................................................. 11-3 Remote Front Display Assembly ................................................................ 11-3 Rear Housing Assembly................................................................................... 11-4 Chassis Assembly ...................................................................................... 11-4 Printer Module ............................................................................................ 11-4 Remote Final Assembly (3010482).................................................................. 11-5 Remote Front Housing Assembly (3010644) ................................................... 11-6 Remote Front Display Assembly (3010655) .................................................... 11-7 Remote Rear Housing Assembly (3010643).................................................... 11-8 Remote Chassis Assembly (3010645)............................................................. 11-9

vii

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1 Introduction Copyright Notice

Copyright 2005, MEDRAD, Inc. All rights reserved. Reproduction of this manual is strictly prohibited without express written consent of MEDRAD, Inc. For more information about MEDRAD products and services, please visit www.medrad.com

Trademarks

MEDRAD VerisTM is a trademark of MEDRAD, Inc.

Restricted Sale

U.S. Federal law restricts the sale of this device on or by the order of a physician.

In Case of Emergency Contact

CE Contact

EC REP MEDRAD Subsidiaries

MEDRAD, Inc. Corporate Office One Medrad Drive Indianola, PA 15051-0780 USA Telephone: 1 (412) 767-2400 FAX: 1 (412) 767-4128 OTHER: 1 (800) 633-7231

MEDRAD, Inc. Service Repair One Medrad Drive Indianola, PA 15051-0780 USA Telephone: 1 (412) 767-2400 FAX: 1 (412) 767-4126 OTHER: 1 (800) 633-7237

Medrad Europe B.V. Postbus 205 6190 AE Beek The Netherlands Imaxeon Pty. Ltd. Rydalmere Metro Centre Unit 2, 38-46 South Street Rydalmere NSW 2116 Australia Telephone: +61 2 8845 4999 FAX: +61 2 8845 4998 MEDRAD Europe B.V. P.O. Box 205 6190 AE Beek The Netherlands Telephone: +31 (0) 43-3585600 FAX: +31 (0) 43-3656598 (Visiting MEBV address:) Horsterweg 24 6199 AC Maastricht Airport The Netherlands

(Alternate address:) P.O. Box 150 Rydalmere BC NSW 1701 Sydney, Australia

Nihon MEDRAD K.K. 9F Central Shin-Osaka Bldg. 4-5-36, Miyahara Yodogawa-ku Osaka 532-0003, Japan Telephone: +81 (0) 6-6350-0680 FAX: +81 (0) 6-6398-0670

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MEDRAD Veris 8600

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International Offices

MEDRAD do Brasil Ltda. Av. Fagundes Filho, 191 conjuntos 51 a 54, 57 e 58 Ed. Houston Office Center Vila Monte Alegre 04304-010 - São Paulo - SP Brazil Telephone: + 55 (11) 5079-6500 FAX: + 55 (11) 5584-8951

Mediwest Denmark ApS Naverland 2 2600 Glostrup Denmark Telephone: +45 38-16 16 16 FAX: +45 38-16 16 46

MEDRAD Middle East & Africa 92 Al Lasilky Street New Maadi Cairo Egypt E-mail: Medrad_ME&[email protected] (If contacting Andre directly, please phone or fax) +00.20.2.754.88.29

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MEDRAD France S.a.r.l.

MEDRAD, Inc. (Asia)

8, rue des Pyrénées — Silic 514 Wissous F-94623 Rungis France Telephone: +33 (0) 1.46.86.98.84 FAX: +33 (0) 1.46.86.98.83

200 Jalan Sultan #09-01 Textile Centre Singapore 199018 Telephone: +(65) 6 292 5357 FAX: +(65) 6 292 7276

MEDRAD Italia S.r.l. Via Togliatti, 111 27051 Cava Manara (PV) Italy Telephone: +39 (0) 382 552882 FAX: +39 (0) 382 552876

MEDRAD Medizinische Systeme GmbH Industriestraße 2b 97332 Volkach Germany Telephone: +49 (0) 9381/80 36 80 FAX: +49 (0) 9381/80 36 85

MEDRAD Mexicana S. de R.L. de C.V. Leibnitz, 204 Col. Anzures Del. Miguel Hidalgo CP. 11590 Mexico City Mexico D.F. 16018 Telephone: +52 (555) 250-6575 FAX: +52 (555) 250-9762

Mediwest Norway AS Aslakveien 14A NO-075 3 Oslo, Norway Telephone: +47 (0) 22-06 57 10 FAX: +47 (0) 22-06 57 15

Mediwest Scandinavia AB Lona Knapes gata 5, plan 2 S-421 32 Västra Frölunda Sweden Telephone: +46 (0) 31-74 82 88 0 FAX: +46 (0) 31-74 82 99 9

MEDRAD UK Ltd. 25 Lancaster Way Business Park Witchford, Ely Cambridgeshire CB6 3NW Telephone: +44 (0) 1353-645024 FAX: +44 (0) 1353-645037

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Introduction

Applicability

This manual applies to the MEDRAD Veris 8600 patient monitor and to the power supply and ECG module used with the MEDRAD Veris 8600 patient monitor. This manual also applies to the optional MEDRAD Veris 8600 remote display.

Purpose

The purpose of this manual is intended to provide instructions for servicing the MEDRAD Veris 8600 patient monitor and optional remote display safely and accurately. It is intended for those qualified to service the patient monitor, whether they be MEDRAD Service Personnel, Certified Laboratory Service Technicians, or MEDRAD authorized international dealers.

Important Safety Notice

The information in this manual is intended for people with adequate backgrounds and experience in electronics and electromechanical devices. Any attempt to repair a sophisticated medical device such as the patient monitor may result in personal injury, property damage, or patient injury.

Intended Use

Refer to the MEDRAD Veris 8600 Patient Monitor Operation Manual.

Certifications

MEDRAD Veris patient monitors and remote displays are equipped to operate at 100-240VAC, 50/60 Hz, and designed to be in compliance with EN 60601-1 (Safety), and EN 60601-1-2 (EMC/ Emissions). MEDRAD, Inc. is EN-ISO 9001/EN 13485 certified. MEDRAD Europe B.V. is EN-ISO 9002/EN 13488 certified. (European Medical Device Directive 93/42/EEC). Nihon MEDRAD KK is ISO 9001/ISO 13485 certified.

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MEDRAD Veris 8600

Medrad Service - Additional Information Regarding Compliance to IEC 60601-1-2 / 2001 2nd Edition

The information contained herein is intended to reflect conformance to IEC-60601-1-2 / 2001 2nd edition Standards. The following statements are cautions. Cautions advise of circumstances that could result in damage to the device. Read and understand these cautions before operating the system. !

CAUTION !

• System may disarm or fail to operate when exposed to high magnetic fields. Portable and mobile RF communications equipment can affect the system. • FOR PROPER OPERATION, use only accessories and options provided by MEDRAD that are designed specifically for the system. Other non-MEDRAD approved accessories or options may cause equipment damage or may result in increased emissions or decreased immunity of the system. System accessories listed in the operation manual comply with the requirements of electromagnetic emissions and immunity standards IEC-60601-1-2 / 2001 2nd edition. • DO NOT USE SYSTEM ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. Recommended separation distances between portable and mobile RF communications equipment and the system The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 KHz to 80 MHz

d = [3.5/V1]

p

80 MHz to 800 MHz d = [3.5/E1] p

800 MHz to 2.5 GHz d = [7/E1] p

0.01

0.12

0.23

0.1

0.37

0.74

1

1.17

2.33

10

3.69

7.38

100

11.67

23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation 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 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

SYSTEM REQUIRES SPECIAL PRECAUTIONS REGARDING EMC.

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Introduction

Install and put into service according to the EMC information provided below: Guidance and manufacturer's declaration - electromagnetic emissions The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.

Emissions test

Compliance

RF emissions CISPR 11

Group 1

The system 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 CISPR 11

Class B: Veris 8600

Harmonic emissions IEC 61000-3-2

Class B: Veris 8600

The system 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.

Voltage fluctuations/flicker emissions IEC 61000-3-3

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

Electromagnetic environment - guidance

Complies

Guidance and manufacturer's declaration - electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

+6 kV contact +8 kV air

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

Electrical/fast transient/burst IEC 61000-4-4

+2 kV for power supply lines +1 kV for input/output lines

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

Surge IEC 61000-4-5

+1 kV differential mode +2 kV common mode

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

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

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

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

3 A/m

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the A.C. mains voltage prior to application of the test level.

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MEDRAD Veris 8600

Guidance and manufacturer's declaration - electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF IEC-61000-4-6

3 V rms 150 kHz to 80 MHz

3 V rms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.17

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

d = 1.17 d = 2.33

p

80 MHz to 800 MHz 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 absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio 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 system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.

b

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

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Introduction

Symbols and Descriptions

Symbol

Regulatory Symbols

Definition European Community Mark ETL Mark FCC (US Federal Communications Commission) Mark

Safety Symbols

ATTENTION! Refer to Operation Manual for Information

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

Shock Hazard Type CF Equipment, defib proof

IPX0

Indicates no protection against ingress of water (remote display)

IPX1

Identifies the degree of protection against fluid as drip-proof (main monitor)

IPX2

Identifies the degree of protection against fluid as drip-proof (power supply) Equipotential Terminal Ground Symbol Indicates the MR magnet and power Indicates distance between MR magnet and monitor Indicates the presence of a battery Recycle batteries following hospital protocols and local environmental regulations. Do not incinerate! Keep away from fire or other sources of extreme heat.

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MEDRAD Veris 8600

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Symbol

Definition Do not dispose of in municipal waste. Wheeled bin symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2002/96/EEC) Risk of electrical shock! Do not remove cover. Refer servicing to qualified personnel.

System Symbols

Fuse Alternating Current (AC)

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Direct Current (DC) Wireless Product Port Symbols

Signal Input Signal Output

IOIOI

Digital Output Air Intake Scavenging Port Communication Port Video Out

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Introduction

Symbol Miscellaneous Symbols

Definition Technical Support Phone Number Manufacturing Contact

SN REF

Serial Number Part Reference Number Place this side against the skin (Blood Pressure Cuff)

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Placement of the cuff over the brachial artery.

2

Single use device only. Do not reuse.

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MEDRAD Veris 8600

Definition of Warnings and Cautions

Definitions for Warning, Caution, and Note symbols: Designates an imminent danger. Non-observance is likely to lead to death or the most severe injuries.

!

DANGER !

!

WARNING !

Designates a possible dangerous situation. Non-observance may lead to death or the most severe injuries.

!

CAUTION !

Designates a possible dangerous situation. Non-observance may lead to minor injuries or damage to the product.

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

NOTE: Indicates that important information follows, a tip that can help you recover from an error, or point you to related details in the manual. Warnings

!

WARNING !

• Read this manual entirely before using the monitor. • Inspect For Damage! User should inspect the system for signs of damage. Do not use the system if failure is evident or suspected. • Possible burn hazard! Do not coil cables inside the MR scanner. • Possible explosion hazard! Do not use the monitor in the presence of flammable anesthetics. The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or Nitrous Oxide. • Possible explosion hazard! Do not use the monitor in the presence of gas mixtures which may be flammable. • Do not use this device in conjunction with flammable anesthetics such as cyclopropane and ether. The monitor can sample from pure oxygen environments, but the monitor itself should never be placed inside an oxygen tent or gas containment apparatus. Proper anesthetic gas waste recovery should be used. When not in operation, this device is not intended to be connected to any pressurized source containing an enriched oxygen environment. • Cables, tubing, and lead wires may present a risk of entanglement or strangulation! Verify safe and proper positioning of these items at all times. • Unapproved modifications to the monitor may cause unexpected results and present a hazard to the patient. • Risk of electrical shock! Do not remove cover. Refer servicing to qualified personnel.

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Introduction

!

WARNING !

• All cords must have hospital grade plugs and be plugged into hospital grade outlets. (The electrical installation of the relevant room must comply with NFPA 70: National Electric Code or NFPA 99: Standard for Health Care Facilities. Outside the United States, the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government). • Do not bring tools containing ferrous material into the magnet room. Risk of serious injury and/or damage to equipment can occur. • Do not route gating cables near or within the scanning volume.

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• Apply brakes to prevent movement. • Improper disposal of batteries may result in explosion, leakage, or personal injury. Do not open batteries. Do not dispose of batteries in a fire. Follow all local regulations concerning the disposal of spent Lead-acid and Lithium-Ion batteries or contact MEDRAD for assistance. • Connect only MEDRAD approved three-lead or five-lead ECG cables from the patient to the ECG module. Do not connect any other signal source to the ECG module. • There is no defibrillator synchronization output on the Veris monitor. Make no connections between the Veris and a defibrillator. • Leakage currents may increase if other equipment is interconnected to the patient. The increased leakage currents may present a hazard to the patient. • PACEMAKER PATIENTS: This device does not include pacemaker spike rejection capability. Heart rate readouts derived from the ECG patient connections are likely to display erroneous high or erratic rates when a pacemaker is in use. Keep pacemaker patients under close surveillance. For pacemaker patients it may be advisable to select the SpO2 function as the primary heart rate source. • High Frequency (HF) surgical equipment may affect ECG operation. The system is not designed to operate in the presence of ESU interference. The patient may be burned. Patient burns can also result from a defective HF surgical equipment neutral electrode connection. • The heart rate calculated by the monitor may be affected by cardiac arrhythmia. • Do not stand on power supply enclosure. Injury from tripping or falling can occur.

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MEDRAD Veris 8600

!

WARNING !

• Do not stand on the base. Possible injury can result from falling. • Do not take the remote display or the ECG module battery charger into the MR scanner room. These contain ferromagnetic material and can be strongly attracted to the magnet causing a safety hazard. • Do not use with an open MRI. Use of the monitor in an open MRI may result in erratic or unavailable monitoring. • Do not stand or sit on monitor accessories tray. Possible injury can result from falling. • Do not stand or sit on monitor accessories tray. Possible injury can result from falling.

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

• U.S. Federal law restricts this device to sale by or on the order of a physician. Cautions

!

CAUTION !

• Use only accessories designated for use with this monitor. Use of accessories not designated for use with the Veris monitor can cause inaccurate measurements and/or a safety hazard for the patient. • This device has been tested to 60601-1-2 specified levels for emissions of and immunity to electrical interference. External disturbances which exceed these levels may cause operational issues with this device. Other devices which are sensitive to a lower level of emissions than those allowed by IEC 60601-1-2 may experience operational issues when used in proximity to this device. • Equipment accuracy may be affected at extreme temperatures. • Do not store equipment at extreme temperature. Temperatures exceeding specified storage temperatures could damage the system. • Avoid routing the DC cable through the magnet room door. Possible damage can occur to the DC cable and/or the scanner room door. • Do not press on the keys with sharp or hard objects. This could damage the keys. Use only your fingertips to press on the keys. • Changes or modifications not expressly approved by MEDRAD, Inc., may void the user's authority to operate the equipment and may also void the warranty. • Do not use the monitor in the path of a Linear Accelerator or Positron Emission Tomography (PET) scanner beam. This could result in inaccurate physiologic parameters or waveforms.

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Introduction

!

CAUTION !

• Transporting the monitor in a mobile scanner trailer can lead to damage from shock, vibration, or extreme temperatures. • Do not allow the conductive parts of the patient electrodes to contact other conductive parts, including ground (earth). • High Frequency (HF) surgical equipment may affect ECG operation. • Do not tip the monitor. Possible injury can result from falling. • Do not pinch cables between the table and the bore. This can damage the cables. • Do not roll the monitor over or step on cables. This can damage the cables.

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• Do not bend fiber optic cables too tightly. Refer to the specifications in Appendix C of the Operation Manual. • If a probe falls on the floor or into liquid, clean the probe following proper cleaning methods. If the probe is not properly cleaned, inaccurate physiologic parameters or waveforms may result. • Do not place more than 40 pounds (18 kg) on the tray. Leakage Current

The monitor complies with leakage current limits required by medical safety standards for patient-connected devices. The Veris monitor conforms to EN 60601-1 standards. A hazard caused by the summation of leakage currents is possible, when several pieces of equipment are interconnected.

Voltage Fluctuations

When operated in the line voltage range specified in this manual any minor fluctuations will have a negligible effect. Very low line voltage will cause the monitor to revert to battery power. Very high line voltage may cause damage to the charger circuits. The monitor is designed with circuitry that will turn the unit off before spurious readings can be caused by a low battery condition.

Equipotential Ground

Health care providers and patients are subject to dangerous, uncontrollable compensating currents for electrical equipment. These currents are due to the potential differences between connected equipment and touchable conducting parts as found in medical rooms.

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MEDRAD Veris 8600

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The safety solution to the problem is accomplished with consistent equipotential bonding. The remote display and the main monitor power supply are fitted with connecting leads made up with angled sockets to the equipotential bonding network in medical rooms. Equipotential Terminal

Connection Lead (Socket) Equipotential Connector

Main Body

Earth Ground Software Version

The initial release of this monitoring system was at a software revision of 1.0 on the main monitor and 1.0 on the remote display on 4 January 2005. This revision could be advanced for many reasons following the initial release. To identify the presently installed revision on either the main monitor or remote display, power-up the monitor while observing the initial power-on screen. The current software revision will be displayed prior to display of the normal monitoring screen.

Software Error Related Hazard Mediation

MEDRAD, Inc., has quality control practices and procedures in place to review potential hazards as they relate to software. The monitor utilizes a four-digit year for all date, time, and leap year calculations.

Potential Interference

MAGNETIC FIELDS

Always position the Veris Base, Base Plus, and Cardiac monitors at or outside the 2000 Gauss line. Always position the Veris Anesthesia monitor at or outside of the 500 Gauss line. This monitor is designed specifically for MR compatibility and is 0.5 to 3T compatible. It will not cause interference with MRI image quality, nor will its performance be affected by the magnet field. The "T" wave may become excessively large or inverted with the patient in the magnetic field. This effect is due to hemodynamic flow induced voltage and may interfere with QRS detection. Try other leads and/or electrode placements for best results. CONDUCTED TRANSIENTS

The monitor conforms with IEC 61000-4-4, and IEC 61000-4-5 for conducted transients, and will operate with negligible adverse effects. X-RAY, CT, ULTRASOUND, AND/OR NUCLEAR MEDICINE

The monitor will operate with negligible adverse effects in these environments. However, the monitor should not be placed directly in the radiated beam, which could damage the internal electronics of the monitor.

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Introduction

OTHER INTERFERENCE

There is a negligible adverse effect to the monitor from electrocautery and electrosurgery, infrared energy, and defibrillation. CABLING INTERFERENCE

Route all Veris system cabling away from other manufacturer cables in the magnet room. Biocompatibility

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Probes Fall in Fluids

FCC and Industry Canada Compliance

All patient-contact or user-contact materials in this monitor and it's accessories have passed ISO 10993-5, -10, & -11 biocompatibility tests or have been in use in clinical environments in large numbers over an extended period of time predating these standards. Whenever probes fall and land in fluids, clean the probes according to the cleaning instructions in “Cleaning and Disinfecting” in Appendix A of the Operation Manual. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including intereference that may cause undesired operation. !

WARNING !

• Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The term “IC” before the certification/registration number only signifies that the Industry Canada technical specifications were met. IC: 5338A-CSI8600 Audible Pulse Tone

The amplitude of the audible pulse tone remains constant regardless of changes in patient parameter measurements.

Accessory Disposal

Discard disposable medical waste according to your institution's policies and procedures to prevent biological contamination. See “Disposal” in Appendix A of the Operation Manual.

Latex Content

This MEDRAD product (patient monitors and approved accessories) are free from latex in any location that may result in patient contact.

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2 Main Monitor Maintenance and Checkout This section contains recommended procedures for maintenance, and an operational checkout of the MEDRAD Veris patient monitor. Routine maintenance and inspection will: • Ensure continued performance of the patient monitor system. • Reduce the possibility of equipment malfunction. Incoming Inspection

You must inspect patient monitors coming back from service for shipping damage before you place them into operation just like newly purchased patient monitors. The patient monitor should be free from dents, cracks, or other physical damage. If further incoming inspection or testing is required, the manufacturer recommends that you use the Alarms Verification (located in this section) as an incoming inspection test. You can perform additional electrical safety testing in this section as part of an incoming inspection in accordance with the policies of the health care provider.

Maintenance Schedule Every Patient

• • • • •

Clean and disinfect the sensor cables and sensor. Inspect the accessories and cables for damage. Change the gas sampling device and sampling line. Check the NIBP function. Change the water trap

Every Day

• Charge the batteries as necessary. If not using the monitor on a patient, keep it plugged into the power supply for continuous charging. • Test the NIBP function.

Every Week

• Charge the ECG module battery.

Every 3 Months

• Clean the exterior of the unit (or clean as needed). • Fully charge the batteries.

• Perform the annual safety tests. • NIBP calibration and safety tests. • Verify the CO2 and agent gas calibration. MEDRAD also recommends that a complete system calibration and performance checkout be performed annually. Contact MEDRAD Factory Service or your local MEDRAD office for complete details.

Every Year

In the United States, Canada, Japan, and Europe, the MEDRAD Service Department offers Preventive Maintenance Programs. These annual programs greatly assist in maintaining accuracy and reliability, and can also extend the life of the system. COntact MEDRAD for details. In Europe, contact your local MEDRAD office or your local authorized dealer for further information. Refer to “MEDRAD Subsidiaries” on page 1-1 and “International Offices” on page 1-2 for address, telephone, and FAX information. NOTE: Failures which occur due to a lack of proper maintenance will not be covered under warranty.

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MEDRAD Veris 8600

Monitor Safety Testing

You can perform the following tests as part of a periodic safety check. If the monitor fails any portion of these tests, contact MEDRAD. The contents of this section include the following verifications and safety tests: • Electrical Leakage • Interface Inspection • Manual Controls Check • Alarm Verification • Vital Sign Modules Verification • ECG • SpO2 • NIBP • IBP

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• Temperature • Gas Flow/CO2/O2 • Communications Repaired modules could require more extensive testing than what is shown in this list. Always follow ESD precautions when performing a procedure discussed in this section. !

WARNING !

• Because test procedures require working with exposed electrical circuits, only experienced electrical or biomedical technicians should perform the procedures. • After a monitor is altered through repair or hardware adjustment, you must fully test it before use. Equipment and Tools

Accessory Testing

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The following procedures assume that the technician has an ESD safe workbench, a set of electronic hand tools, and a digital multimeter with a 10 amp setting. At the beginning of each test, special equipment can be listed. A variety of customized cables, clips, and test fixtures are also needed to complete the tests. For more information, contact MEDRAD. Check the electrical safety of the power cord as part of the patient monitor safety testing.

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Main Monitor Maintenance and Checkout

Cleaning and Disinfecting

!

WARNING !

• Shock Hazard! Before cleaning the patient monitor, turn the power off and disconnect the AC power cable. • Shock Hazard! Never immerse the patient monitor because the patient monitor has an internal power source that is active even when the unit is unplugged. Do not use abrasive cleaners on the patient monitor or on any sensors or probes. Abrasive cleaners damage the patient monitor. With the exception of the display screen, wipe clean the exterior surface of the patient monitor with alcohol. Dry it with a soft, dry cloth. Because paper towels or tissues can scratch the surface of the display, use a cotton cloth to clean the patient monitor. Do not use full-strength alcohol on the display screen. Repeated use of strong cleaners damages the screen. Clean the display window by wiping it clean with a soft, lint-free cloth sprayed with common glass cleaner, however, do not spray glass cleaner directly on the display. Accidental Wetting

!

WARNING !

• Shock Hazard! Because a patient monitor is an AC-powered device, an immersed patient monitor presents a danger to anyone who attempts to handle the device. Immediately perform the following steps following an accidental wetting of equipment: 1. Turn the power off. Disconnect AC power from the patient monitor. 2. If the monitor is monitoring a patient, transfer the patient to another monitor as quickly as possible. 3. Use a clean, dry towel or cloth to remove the liquid from the patient monitor housing. 4. A service technician should inspect the patient monitor as soon as possible. 5. If the internal mechanism is saturated, allow the liquid to drain out for 24 hours before shipping. 6. If liquid has entered the patient monitor, it must be dried and cleaned internally. Full testing is required before you can use the monitor. Contact MEDRAD as soon as possible. Time is critical. The longer any liquid remains in the patient monitor, the more damage it can do. It is important to service the patient monitor immediately after any liquid is spilled into it.

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MEDRAD Veris 8600

Battery Safety

The batteries require no maintenance. For more information, refer to the MEDRAD Veris 8600 Patient Monitor Operator’s Manual. !

CAUTION !

• Do not short circuit the battery terminals! The resulting highcurrent discharge can cause burns. • Charge the battery completely after extended battery use to ensure a fully-charged battery is available for the next use. • Explosion hazard! Keep lighted cigarettes, sparks, and flames away from the battery. • The battery contains sulfuric acid electrolyte that can cause severe burns and eye damage, as well as illness from sulfur oxide fumes. • Do not crack, cut, burn, or dissolve (with solvents) the battery case. Damaging the battery case can cause the release of sulfuric acid. If sulfuric acid is released from the battery, wear eye protection and rubber gloves to handle the battery, and use a solution of baking soda in water to neutralize the sulfuric acid. • Do not incinerate the batttery. The used battery is a potential environmental hazard and must be disposed of properly. Dispose of the old battery in accordance with local and federal laws. Long-Term Monitor and Battery Storage

No special preparation is necessary for long term storage of the monitor. Although you do not have to remove the battery from the monitor for long term storage, the battery drains to an unrecoverable state after 3 months without periodic charging.

Monitor and Accessories Disposal

At the end of its useful life, you can dispose of the monitor and its accessories according to your institution’s policies and procedures for disposal of patient-contact medical waste. Alternately, you can return the monitor and its accessories to MEDRAD, Inc., for safe disposal. The shipping address is: MEDRAD, Inc. One Medrad Drive Indianola, PA 15051-0780 USA

Fuse Replacement

There are two AC power fuses located at the AC input side of the power supply directly above the AC power entry socket. See the fuse specifications for the proper fuse. 1. Pry the cover from the fuse well above the AC cord. 2. Gently remove the fuse assembly and remove the spent fuse(s). 3. Replace fuses and reassemble in reverse order.

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Main Monitor Maintenance and Checkout

Electrical Safety Testing (Main Monitor)

Perform this test each time you open the patient monitor housing and before you use the monitor on patients. !

WARNING !

• Shock Hazard! Because dangerous and lethal voltages are present during the withstanding voltage, leakage, and ground continuity test, all leakage and voltage testing must be done with the monitor housing in place. For complete information about the proper operating and safety procedures, refer to the Veris 8600 Patient Monitor Operator’s Manual. Leakage Test Equipment and Setup

Perform all testing with the cover on. The following test requires a Dynatech 232D leakage tester or equivalent.

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1. Perform a self-test, if applicable, on the DYNATECH 232D by plugging it into 110 VAC outlet. Turn on the leakage tester. Set the mode switch to self test. Display should read 1000 ±20 and the CURRENT SOURCE ACTIVE lamp should be on. !

CAUTION !

• If these conditions are not met, do not continue with this test. 2. Set the mode switch on the Dynatech 232 to L1-L2 (line voltage). The display should read the line voltage ±10%. Set the mode switch to L1-GND. The display should read no more than 5% of L1-L2 on a grounded power system. Set the mode switch to L2-GND. NOTE: This should read about the same as the L1-L2 reading for a grounded system. Leakage Test Procedure

The monitor must be powered up during all of the isolation tests. 1. Turn the mode switch to EARTH CURRENT LEAKAGE. Connect the AC cord from the Dynatech 232D to the monitor, and turn on the unit. With the POLARITY switch in the NORMAL position, press OPEN GROUND and monitor the readout for less than 0.25 mA at 120VAC. 2. Change the polarity switch to the REVERSE position, press OPEN GROUND and monitor the meter for less than 0.25 mA at 120VAC. 3. With the POLARITY switch in the NORMAL position, press OPEN NEUTRAL and OPEN GROUND switches and monitor the meter for less 0.25 mA at 120VAC. 4. Change the POLARITY switch to the REVERSE position and press the OPEN NEUTRAL and OPEN GROUND switches and monitor the meter for less than 0.25 mA at 120VAC. 5. Cardiac and Anesthetic models only: Connect an IBP ground leakage cable to a brown lead of the leakage tester. Turn the LEADS selector switch to the ISO position. Turn the POLARITY switch to NORMAL, press the ISO TEST button, and monitor the meter for less than 20 microamps. Verify IBP current leakage is less than 0.020mA. 2-5

MEDRAD Veris 8600

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Functional Testing Interface Inspection

1. Verify that a readable screen displays. For a guide to proper screen layout, refer to the Veris 8600 Patient Monitor Operator’s Manual for sample screens. 2. Verify that the screen display is clear and bright when you directly face the patient monitor. 3. Verify the image quality. There should be no intermittence or jittering of pixels. The maximum amount of pixels missing from any display are as follows: • Maximum number of bad dots allowed per screen is 7. • Maximum number of bad dots within any 20mm radius circle is 1. Manual Controls Check

This copy of 3010798 Rev 0 is valid as of Nov-04-2005 at 12:12:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

This procedure is for the monitor’s TFT active display.

1. Verify that rotating the menu knob moves the cursor through the menu items. Verify that when you press the menu knob on a highlighted menu item the monitor displays a sub-menu. 2. Use the menu knob to enter the CONFIG window and set the date and time for the real time clock. 3. Press the FREEZE key. Verify that you get an audible response from the speaker. Press the FREEZE key again to unlock the waveforms. 4. Press the TREND key. Verify that you get an audible response from the speaker. A Trend window appears on the display. Press the TREND key again to close the Trend window. (Or optionally, press and hold the TREND key to open the TYPE/INTERVAL/ SCREEN menu that you close by selecting EXIT.) 5. Press the STAND BY key. Verify that you get an audible response from the speaker. A standby confirmation menu or ALARM STANDBY MODE message should appear. Press the STAND BY key again to return to the screen. 6. Press the DEFAULT key. Verify that you get an audible response from the speaker. The Custom Default menu appears. Select NO and then select EXIT to return to the Main window. 7. Press the NIBP CYCLE/STAT key. Verify an audible response from the speaker. The NIBP STAT/Cycle Time menu appears. Choose EXIT to return to the Main window. 8. Press the NIBP key. Verify an audible response from the speaker and that the NIBP pump runs. Press the NIBP key again to cancel the reading. 9. Press the PRINT key. Verify an audible response from the speaker. NOTE: Since no printer is present, nothing should happen. The audible response verifies that the key is functional. 10.Press the SILENCE Key. Verify an audible response from the speaker and that a silence symbol appears in the top, right hand corner of Waveform 1.

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Main Monitor Maintenance and Checkout

Fiber Optic Communication

This test is for units with a remote display. If the Veris patient monitor does not have a remote display, skip this test. To verify fiber optic communication: 1. Enter the CONFIG menu and select ENTER NETWORK CONFIG. 2. Enter the password (MEDRAD) to enter, then click on Yes. 3. Set to the following: • Sync Type:

Fiber Optic

• IP Address:

192.168.000.xxx

• Net Mask:

255.255.255.000

• Port:

02571

• Channel Type:

Peer-to-Peer

• Channel:

X

• SSID:

Any

4. Select Exit to effect changes. 5. Re-cycle the power to save the setting. 6. Turn on a test Veris remote display set to Fiber Optic. Verify communication. 7. Use the encoder to verify that the screen on the remote display replicates what is present on the main monitor. 8. Press the PRINT key on the main monitor and verify that the remote display prints data.

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MEDRAD Veris 8600

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Alarms Verification

To verify the alarm circuitry for SpO2, perform the following procedure. 1. In the PARAMS window turn off all monitoring modules except for SpO2. Set the display to show a plethysmograph waveform. 2. In the PARAMS window set the SpO2 Low Limit Alarm setting to HIGH. This sets the alarm priority for only this alarm parameter. 3. Use an SpO2 simulator to set the monitor to display the plethysmograph waveform. Confirm the heart rate reading appears in the HR parameter box and the saturation reading appears in the SpO2 parameter box. 4. In the ALARMS window adjust the SpO2 low alarm level above the saturation reading to cause an alarm condition.

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5. Verify that the message LOW SPO2 appears at the top of the waveform channel in red letters. 6. Verify that you get an audible response. The alarm should be a high priority alarm tone consisting of 3 beeps followed shortly by two beeps. 7. In the PARAMS softkey window, change the SpO2 Low Limit Alarm setting to MEDIUM. 8. Verify that the message LOW SPO2 appears at the top of the waveform channel in yellow letters. 9. Verify that you get an audible response. The alarm should be a medium priority alarm tone consisting of 3 beeps. ALARM VOLUME TEST

1. From the ALARMS window, vary the Alarm Volume through the ranges, from 1 to 10. Verify that the speaker volume changes according to the setting of the Alarm Volume. 2. Press the alarm SILENCE key once. Verify that the low heart rate alarm stops for 2 minutes and that the 2-minute Alarm Silence symbol appears in the top, right hand corner of Waveform 1. 3. Press and hold the alarm SILENCE key for at least 2 seconds. Verify that the low heart rate alarm stops and the infinity Alarm Silence symbol appears in the top, right hand corner of Waveform 1.

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Main Monitor Maintenance and Checkout

Module Verification NIBP Verification

The NIBP verification requires Dynatech Nevada NIBP Analyzer. Connect the 8600 monitor to a Dynatech Nevada NIBP Analyzer set for the following operation. NIBP Analyzer Settings Adult 120/80 (90); Heart Rate 80 bpm Neonate 80/50 (62); Heart Rate 80 bpm Pressure Adjustments: Gain 100%; Shift 4 1. Use the T-connection with a small adult or adult cuff for these tests. Wrap the cuff around the monitor’s pole. Connect the cuffs to the 0-300 mmHg port of the NIBP analyzer. 2. Connect the monitor to an AC (mains) power source and turn on the monitor.

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3. Press and hold down the monitor’s NIBP CYCLE/STAT key. The monitor’s cycle time window appears. 4. Select the NIBP Cycle Time to two minutes. 120/80 OPERATION SETTING

1. In the monitor’s ADM/DIS window set the Patient Size to Adult mode. 2. Connect the NIBP hose to the fitting on the monitor. 3. Press the NIBP key. 4. Allow the monitor to take at least four (4) readings. Calculate the average of the four (4) readings and verify that each reading does not vary by more than ±4% or ±4mmHg (whichever is greater) from the calculated average. Each reading shall not vary more than 8 mmHg from the simulator setting. 5. Recalibrate the monitor if necessary. 80/50 OPERATION SETTING

1. Set the monitor to the Neonate mode. Use a Neonate cuff wrapped around a post on the tray. 2. To verify STAT mode operation, press and hold the NIBP CYCLE/STAT key. 3. Allow the monitor to take at least four (4) readings. Calculate the average of the 4 readings and verify that each reading does not vary by more than ±4% or ±4mmHg (whichever is greater) from the calculated average. Each reading shall not vary more than 8 mmHg from the simulator setting.

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MEDRAD Veris 8600

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SpO2 Verification

The following test requires a SmartSat SpO2 analyzer and an 8-pin serial test connector with a BNC connection at one end. 1. Verify that the message SPO2: NO SENSOR appears when there is nothing connected to the SPO2 connector. 2. Verify that the message SPO2: SENSOR appears when you plug the finger sensor in, but without a finger actually inserted into the sensor. 3. Verify that the message SPO2: HIGH AMBIENT appears by introducing a higher than normal amount of ambient light on the SpO2 sensor detector. Verify the message disappears within 10 seconds after you remove the ambient light. 4. Place the SpO2 finger sensor on an index finger and verify that the heart rate and plethysmograph operation display on the LEDs within 15 seconds. Verify that SpO2 error messages do not appear (alarm violations can occur depending on individual readings and monitor set-up). 5. Select Pleth in a waveform setting in the DISPLAY menu. Verify the LCD displays a plethysmograph waveform. Connect the 8pin serial test cable to the monitor: the 8-pin connector to COM2 on the monitor and the BNC connector into an oscilloscope channel. In the CONFIG window, scroll to ANALOG OUT SELECT, then select PLETH. Use the SpO2 finger sensor to verify that the SpO2 waveforms appear on the scope. The waveform should be centered on 0 volts and register 1 volt peak-to-peak. Remove the SpO2 cable. 6. Verify that the pulse tone increases as you change the tone from 1 to 10 in the Alarm Setting window. 7. Use an optical load to simulate a small signal and verify that the message SPO2: SEARCH or LOST appears after search delay time ± 5 seconds. (An optical load that can be used for this test is a foam peanut used for packing.) 8. Enter the DISPLAY screen and change the SpO2 waveform size to x2 and x4 and verify the scale change on the display for each setting. Return size setting to x1. 9. Connect a Smart Sat SpO2 simulator and verify the readings are within the acceptable tolerance found in the “Smart Sat Procedure” on page 2-11.

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Main Monitor Maintenance and Checkout

Smart Sat Procedure

Equipment needed: • SmartSat SS-100A or equivalent pulse oximetry analyzer 1. Turn on the pulse oximetry analyzer. Press F1 (Sp02 Sim) and then F2 (AutoSeq) to access the Programmable AutoSequence Directory. 2. Press F1 (Select ) or F2 (Select ) to select the file “CSI 1”. When the file has been selected press F5 (Run) to begin the program. 3. Insert the SpO2 cable from the pulse oximetry analyzer in to the unit to be tested. 4. Turn on the monitor to be tested. Press F1 (Start) on the pulse oximetry analyzer to begin the simulation.

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5. Verify the monitor stabilizes within the limits given for each level. Use Smart Sat Auto Sequence “CSI 1”. Level 1 2 3 4 5 6 7

SpO2 99% 96 90 78 61 52 40

Limits 97 - 99% 94 – 98 88 – 92 76 – 80 58 – 64 49 – 55 37 – 43

Heart rate 40 bpm 60 80 100 120 180 300

Limits 39-41 bpm 59-61 79-81 99-101 119-121 179-181 297-303

6. If the Veris monitor fails only 1 level, rerun that level using the manual mode of the pulse oximetry analyzer. a. Press PREV (2) times and then F1 (Manual). b. Press F4 (Change+), and F5 (Change-) to manually set the SPO2 %. c. Press F3 (-->Select) to select pulse rate. Press F4 (Change+), and F5 (Change-) to manually set the PULSE RATE (BPM). d. Allow 30 seconds for the readings to settle. If the readings settle within the given limits, pass the monitor. SpO2 Gating Verification

1. Connect a gating test cable to the GATING connector on the monitor. 2. Enter the PARAMS menu and set Gating to SpO2 Pulse. 3. Verify that the gating output matches the heart rate frequency.

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MEDRAD Veris 8600

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ECG Verification

This test requires a Dynatech Nevada Model 300 simulator. NOTE: For Base and BasePlus models, begin with step 5. 1. Select the PARAMS menu to set up for ECG PARAMS to 5Lead, ECG ON, Filters: MONITOR, SENSITIVITY to HIGH. 2. Insert a shorted ECG cable into the ECG connector. Use the menu knob to enter the DISPLAY window. Set the following and use the current defaults for the size. They are 25MM except waveform 1: • Waveform 1 ECG I x 4.0 25.0 • Waveform 2 ECG II x 4.0 25.0 • Waveform 3 ECG V x 4.0 25.0 3. Exit the DISPLAY window. Verify that the baselines are centered. Verify that the base line signal is no greater than 3 pixels in height. Select the most solid line as the reference line and verify that this reference is less than ±3 pixels from the ECG y-axis center line. Remove the shorted cable. 4. Verify that the message LEADS OFF appears at the top of the window when a cable is not connected. 5. Connect the 3-lead ECG patient cable to the ECG cable assembly, and use a Dynatech Nevada Model 300 simulator to turn on (ECG) normal sinus, 60BPM, amp 1.0mV, axis int. Respiration rate 20, and the impedance set for 0.5 ohms, and base impedance for 2K. Set the “Lead select” on the simulator to Lead II. 6. Rotate the menu knob to select PARAMS and press to enable the menu. Select for ECG Cable: 3 lead). Set the monitor for LEAD II waveforms. Check the following lead configurations for the following items: • Heart rate 60 ±3 BPM, • RESPIRATION RATE of 20 ±2 breaths per minute and • Correct waveform.

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Main Monitor Maintenance and Checkout

7. Use the Electrode status error messages on the monitor display to perform a lead off check in LEAD II. (LL) Red (LA) Black (RA) White

LEAD OFF LA LEADS OFF RA LEAD OFF

NOTE: This completes the ECG Verification for Base and BasePlus models. Continue with the Electrical Safety tests. 8. Connect all the leads back on the simulator and select ECG Cable to 5-lead. Set the monitor for LEAD I waveforms. Verify that the following messages appear and lead switching occurs as each lead is disconnected one at a time (reconnect the cable to eliminate the message and return the waveform): (V1) Brown (LL) Red (LA) Black (RA) White

V LEADS OFF LEADS OFF LA LEAD OFF RA LEAD OFF

LEADSWITCH TO LEAD II LEADSWITCH TO LEAD III

NOTE: The Green lead (RL) does not display a lead off message. Verification is not required. 9. Check the following lead configurations for following items: • Heart rate 60 ±3 BPM, • Correct waveforms.

10.Set the Dynatech MED SIM300 to a heart rate of 300BPM. Verify that the ECG HR reads 300BPM ±1BPM. 11.Turn off the simulator and verify that the message ECG LOST appears at the top of the window. 12.Turn the simulator back on and set the simulator for 60BPM, LEAD II and verify that the gain settings are effective at x.5, x2, and x4 for 1mv ECG input. 13.Select ECG on the simulator, select base, then BPM, and 60. This gives a normal sinus rhythm at this time. Select ECG, then ARRH, then VNT2, and then VFIB. The unit should detect an erratic baseline and display the message ECG LOST. 2-13

MEDRAD Veris 8600

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ECG Gating Verification

1. Enter the PARAMS menu and set Gating to ECG Pulse. 2. Set the ECG simulator to normal sinus and heart rate to 60bpm. Connect a modified gating cable from the GATING connector on the monitor to an oscilloscope and verify that the frequency of the output matches the input BPM.

IBP Verification

The main focus of the following steps is the MED SIM 300 (or its equivalent). This is only for monitors with IBP (Cardiac and Anesthetic models). 1. Attach the IBP cable from BP1 on the simulator to IBP 1 on the monitor’s connector panel. 2. Select BP on the simulator. Select Channel 1. Select STAT. Select ZERO by using the up and down arrows on the MED SIM 300, scroll through the menu until STAT appears and press to select. 3. Rotate the rotary encoder knob to highlight PARAMS and move down to IBP1. Press the menu knob once. Set the SITE for ART. 4. Press the rotary encoder knob again. Adjust the RANGE. This should be set for 0-200. Press the rotary knob until you reach IBP1 again. 5. Exit out of PARAMS. Use the rotary encoder knob to scroll to select the IBP1 ZERO selection on the display. Observe that a 0 (zero) appears on the screen next to the line that contains ART (---/---( 0 ) MMHG. 6. Return to the Medsim and select WAVE and execute. Select ART for ARTERIAL and press EXE to execute the function. Observe the waveform on the screen. Verify that the pressure reads 120/80 ±2MMHG. 7. Attach the IBP cable from BP2 on the simulator to IBP 2 on the monitor’s connector panel. 8. Select BP on the simulator. Select Channel 1. Select STAT. Select ZERO by using the up and down arrows on the MED SIM 300, scroll through the menu until STAT appears and press to select. 9. Rotate the rotary encoder knob to highlight PARAMS and move down to IBP2. Press the menu knob once. Set the SITE for CVP. Press the rotary encoder knob again. Adjust the RANGE. This should be set for 0-20. Press the rotary knob until you reach IBP2 again. 10.Exit out of PARAMS. Use the rotary encoder knob to scroll to select the IBP2 ZERO selection on the display. Observe that a 0 (zero) appears on the screen next to the line that contains CVP ( 0 ) MMHG. 11.Return to the Medsim and select WAVE and execute. Select CVP and press EXE to execute the function. Observe the waveform on the screen. Verify that the pressure reads 12 ±1MMHG.

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Main Monitor Maintenance and Checkout

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Temperature Verification

1. Measure room air temperature using each probe (1 and 2) and compare the output with a calibrated thermocouple. Verify each reading is within 0.5°F of each other and the thermocouple. 2. Place each probe and the thermocouple probe between an index finger and a thumb. Verify each reading is within 0.5°F of each other and the thermocouple.

Anesthesia/CO2/O2 Verification

Turn on the monitor and then rotate the menu knob to select the PARAMS window. Go to Other Params Menus and select Gas Menu. Select the unit of measure for PERCENT under CO2. PNEUMATIC LEAKAGE TEST

1. Power cycle the monitor. After the monitor has completed the auto-cal, connect a vacuum gauge to the sample line of the water trap. Verify that the vacuum at the sample line is greater than 10 inches of mercury within 30 seconds.

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OCCLUSION TEST

1. With the vacuum gauge still attached, verify the OCCLUSION message appears on the screen and that the pump runs at a higher speed to clear the occlusion. EXHAUST FLOW VERIFICATION

1. Verify that the exhaust flow is fluctuating approximately 100 mL/min – 200mL /Min. 2. Obstruct the exhaust port (pinch tubing or cover the port with a finger) and verify the AGT: NO EXHAUST message appears. VERIFY EXPIRED O2

1. Run 5% CO2, 95%N2 mixture connected via a breathing simulator to the sample line. Verify the expired O2 is less than 1%. NOTE: If any verification fails, contact MEDRAD service.

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MEDRAD Veris 8600

Electrical Safety Testing (Power Supply)

!

WARNING !

• Shock Hazard! Because dangerous and lethal voltages are present during the withstanding voltage, leakage, and ground continuity test, all leakage and voltage testing must be done with the monitor housing in place. For complete information about the proper operating and safety procedures, refer to the Veris 8600 Patient Monitor Operator’s Manual. Verification of Fuses and Assembly

Leakage Test Equipment and Setup

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Perform this test each time you open the power supply housing.

1. Using a small flat head screw driver, remove fuse drawer with a prying motion. Inspect the fuse rating on each fuse of the AC inlet. Replace if not specified rating (3.15A @ 250V). Perform all testing with the cover on. The following test requires a Dynatech 232D leakage tester or equivalent. 1. Perform a self-test, if applicable, on the DYNATECH 232D by plugging it into 110 VAC outlet. Turn on the leakage tester. Set the mode switch to self test. Display should read 1000 ±20 and the CURRENT SOURCE ACTIVE lamp should be on. !

CAUTION !

• If these conditions are not met, do not continue with this test. 2. Set the mode switch on the Dynatech 232 to L1-L2 (line voltage). The display should read the line voltage ±10%. Set the mode switch to L1-GND. The display should read no more than 5% of L1-L2 on a grounded power system. Set the mode switch to L2-GND. NOTE: This should read about the same as the L1-L2 reading for a grounded system. Leakage Test Procedure

The monitor must be powered up during all of the isolation tests. 1. Verify Normal Earth Leakage is <0.25 mA at 120VAC line voltage. 2. Verify Earth Leakage with Reverse Polarity is <0.5mA at 120VAC line voltage. 3. Verify Earth Leakage with Open Neutral is <0.5mA at 120VAC line voltage. 4. .Verify Earth Leakage with Reversed Polarity and Open Neutral is <0.5mA at 120 line voltage. 5. Verify Normal Enclosure Leakage is <0.05mA at 120VAC line voltage. 6. Verify Enclosure Leakage with Reversed Polarity is <0.25mA at 120VAC line voltage. 7. Verify Enclosure Leakage with Open Neutral is <0.25mA at 120VAC line voltage.

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Main Monitor Maintenance and Checkout

8. Verify Enclosure Leakage with Reversed Polarity and Open Neutral is <0.25mA at 120VAC line voltage. 9. Verify Enclosure Leakage with Open Earth Ground is <0.25mA at 120VAC line voltage. 10.Verify Enclosure Leakage with Reversed Polarity and Open Earth Ground is <0.25mA at 120VAC line voltage. Output Verification

1. Apply 120VAC to the AC inlet using a standard AC power cord. 2. Measure at the DB-15 connector. a. Measure between pins 1 and 8. Verify that the voltage is 16.5VDC (±0.2VDC). b. Measure between pins 2 and 9. Verify that the voltage is 16.5VDC (±0.2VDC).

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c. Measure between pins 3 and 10. Verify that the voltage is 16.5VDC (±0.2VDC). NOTE: If 0V is the measured output, this would indicate an open wire or miswired connection.

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MEDRAD Veris 8600

ECG Module Verification Equipment Needed

• 1 ECG patient simulator (Fluke 217A or equivalent) • 1 5-Lead ECG Leadset (3010473) • 1 ECG fiber optic cable (3005290) • 1 Hi-Pot Tester • 1 100K-Ohm resistor with 2 8x32 screws and nuts.

Verification of ECG Module Charger

1. Connect the ECG moldule to an ECG Module Charger and verify that the green LED flashes slowly with an approximately 50% duty cycle. 2. Turn on the ECG moldule and verify that the fiber optic transmitter lights for approximately 1 second. 3. Turn off the ECG module and disconnect it from the charger.

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Risk Current Testing

1. Turn on the ECG module and record and verify the following voltages. NOTE: Verify that all switches not specified as positive are negative. Positive RA LA LL V RL

ECG Display Testing

Tied to LA, LL, V, RL RA, LL, V, RL RA, LA, V, RL RA, LA, LL, RL RA, LA, LL, V

Range 1.75 to 2.75mV 1.75 to 2.75mV -5.50 to –7.50mV 1.75 to 2.75mV -0.1 to 0.1mV

1. Remove the ECG module safety tester and connect an ECG patient simulator by using the 5-Lead ECG Leadset. 2. Set the ECG patient simulator to the following settings: Normal rhythm, 60bpm, 1mV amplitude 3. Set the Veris monitor to display ECG Leads II, III, and V. 4. Confirm that all three leads display as described. NOTE: The ECG module needs to be on for this test. Verify that Lead II displays a waveform with normal rhythm at 60bpm. Verify that Lead III displays a waveform about 1/3 of the size of Lead II with a normal rhythm at 60bpm. Verify that Lead V displays a waveform with the opposite polarity of Lead II and a normal rhythm at 60bpm.

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Main Monitor Maintenance and Checkout

ECG Lead-Off Testing

1. Remove the LA connection from the ECG module. a. Verify that the message ECG: LA LEAD OFF appears. b. Verify that the Lead III and Lead V traces becomes flat. c. Verify that the Lead II trace is unaffected. d. Replace the LA connection. 2. Remove the RA connection from the ECG module. a. Verify that the message ECG: RA LEAD OFF appears. b. Verify that the Lead II and Lead V traces becomes flat. c. Verify that the Lead III trace is unaffected. d. Replace the RA connection. 3. Remove the V connection from the ECG module.

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a. Verify that the message ECG: V LEAD OFF appears. b. Verify that the Lead V trace becomes flat. c. Verify that the Lead II and Lead III traces are unaffected. d. Replace the V connection. 4. Remove the LL connection from the ECG module. a. Verify that the message ECG: LEADS OFF appears. b. Verify that all lead traces become flat. c. Replace the LL connection. 5. Remove all test connections from the ECG module.

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3 Main Monitor Troubleshooting This section lists the possible causes of monitor problems. Use this table and the drawings in Section 6 to identify and locate components that malfunction. Symptom

Problem

Solution

• Main Board fuse blown • Bad membrane

Recharge the battery Reconnect DC power cable at PS2 on Main Board Replace F3 on Main Board Replace the keypad membrane

Cannot activate hardkey function or turn on monitor with AC power (On/Off LED is green)

• Membrane panel is disconnected or loose • Keypad membrane is bad

Reconnect ribbon cable to J7 on Main Board Replace keypad membrane panel

Display is blank or not readable

• Video screen cables to Main Board are disconnected or loose • Inverter not plugged in

Reconnect data and inverter cables to connectors on Main Board (J2, J3, J4, and/or J5) Make sure all Inverter connections are secure. Replace the inverter

Unit won’t power up (On/ Off LED is dark)

• Battery is dead • Main Board is disconnected

• Bad inverter No sound from speaker

• Volume turned down • Main Board connection is disconnected or loose • Speaker wire broken at speaker terminals

Set volume higher in Configuration window. Reconnect J20 on Main Board Check speaker wires for breaks or bad crimp pins

Speaker scratchy or unclear

• Metal debris on speaker • Bad speaker

Remove debris from speaker drum Replace speaker

COM 1 serial interface doesn’t work

• • • •

Reset monitor to external printer Replace with correct serial cable Reset baud rate and other settings Replace the Main Board

No ECG trace displays

• ECG module battery may not be charged. • ECG Cable may be bad. • The connection between Main Board J17 and VSM Board P1 is loose or disconnected. • Fiber optic cable from ECG Gating Board may be loose or disconnected. • Fiber optic cable from ECG Gating Board may be bad. • Main Board or VSM Board may be bad.

Set to internal printer Incorrect or bad cable Setting mismatch Connector is bad

Charge ECG module battery. Replace with known good cable. Reseat the connection.

Reseat the connection. Replace cable. Replace Board(s)

3-1

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MEDRAD Veris 8600

Symptom No NIBP reading displays

Unit does not communicate with the remote display

Problem

Solution

• Check for leaks in cuff or cuff hose. • Tubing at NIBP module at base of unit may be pinched or loose. • Tubing at the pressure transducer on the Main Board or at receptacle at top of unit may be pinched or loose. • NIBP module may be bad.

Replace with known good cuff or hose. Reseat or replace loose or pinched tubing.

• Fiber optic cable to remote display may be loose or disconnected. • Fiber optic cables not connected properly

Reseat or reconnect fiber optic cable.

• Fiber optic cable may be bad. • Remote display may be malfunctioning • Network settings in the CONFIG. menu may be incorrect. • Communication Board may not be seated tightly to the Main Board. • Communication Board may be bad. SpO2 is “noisy”

Temperature not working properly (readings are out of spec.)

3-2

• Sensor may be bad. • Receptacle may be damaged. • The connection between Main Board J17 and VSM Board P1 is loose or disconnected. • Main Board or VSM Board may be bad. • The connections on the Temperature Board are loose or disconnected. • Temperature cables or Board may be bad.

Reseat or replace loose or pinched tubing. Replace NIBP module.

Make sure that the fiber optic cables go from “TX” to “RX”. They should NOT go “TX” to “TX”/”RX” to “RX” Replace fiber optic cable. Try another remote display with the system. Reset network settings to correct settings. Verify Communication Board is seated to the Main Board. Replace Communication Board Replace the sensor. Replace receptacle. Reseat the connection.

Replace Board(s) Reseat the connections. Replace Board and cables.

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Main Monitor Troubleshooting

Troubleshooting and Repair

Before attempting to repair a damaged monitor the technician must fully understand the functions of the monitor. The service technician should have read and understood all the previous sections of this manual. You must fully repair, calibrate, and test all damaged monitors before you use them on patients. The monitor must meet the original operating specifications before you use it on a patient. Always follow ESD precautions when performing any of the procedures discussed in this section.

Main Board

The Main Board contains the primary processors, storage memory, NIBP circuitry, communication interfaces, audio driver, vital signs module connections, low voltage power regulation, and video generation and keypad inputs (User I/O). The Main Board has an adjustable pot R84 that you set during NIBP calibration. There are two CPUs on the Main Board that you must program from a Service Download Station. The programmable settings remain in non-volatile memory. Repair or improper handling of the Main Board can corrupt this software. There are two replacable 3-amp time-delay fuses (F1 and F3) for the battery input at PS1. There is one replaceable 4-amp time-delay fuse for the power supply module at PS2 (F2 protects the supply output). If you replace the Main Board you are required to cal-check the NIBP module. NIBP pneumatics assemblies and Main Boards may not be changed unless re-calibrated. The Main Board is not a field-repairable component. Replacement Main Boards are pre-tested, programmed, and calibrated.

!

DANGER !

• High Voltage! Remove the battery connections before servicing the Main Board.

3-3

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MEDRAD Veris 8600

Power Supply !

DANGER !

• High Voltage! Repairing and testing the power supply requires working with dangerous voltages. The power supply module should only be serviced by experienced electrical repair technicians. The external power supply is not field servicable. Return the power supply to MEDRAD for service. Fuse Replacement

The main fuses for the power supply is located in an external compartment above the AC power cord connection. Replace only with T 4A L 250V fuses.

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You do not have to open the power supply case to change the main power fuses. See “Fuse Replacement” on page 2-4.

!

WARNING !

• Shock hazard. Substitution of fuses or jumping the fuse contacts can endanger the patient and damage the monitor.

3-4

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4 Main Monitor Theory of Operation Power Module

The patient monitor employs a universal switching power supply for international use. In order to monitor the status of the line power and the condition of the battery pack, the internal power supply circuitry drives several status lines available to the main module. The power management/ watchdog circuit provides a low battery level detection mechanism and a hardware-based check on software operation (watchdog timer).

Main CPU and System

The microprocessor circuitry handles the Main Board computational functions and provides integrated I/O functions, including timers, I/O pins, serial interfaces, and analog I/O. The CONM module contains a microprocessor and associated circuitry for NIBP and the ability to control the optional Capnometer Module. No electrical connection is made with the patient from the monitor for NIBP. The vital signs parameters are passed to the main module using a serial channel.

Vital Signs Module

The vital signs module is a single printed circuit board with connectors to the Main Board, the ECG input leads, the SpO2 connector, and the temperature sensor. The vital signs module contains a microprocessor and associated circuitry for pulse oximetry, temperature, ECG signals, and TTI respiration. ECG signals can be either 3-lead single channel or 5-lead triple channel. Patient isolation for galvanic contact is required for the temperature and ECG functions. Patient isolation for non-galvanic contact is required for the pulse oximetry sensor. A CAN Bus passes the vital signs parameters to the main module. The main module sends the vital signs module control information and the vital signs module sends the main module waveforms and hardware status. The communication cycle is 20 Hz for the vital signs information from the vital signs module, twice a second for the status of the vital signs module, and as needed for the control information from the main module.

Speaker Driver

The speaker drive circuit is a DAC controlling speaker volume and an output pin to control frequency. A software-controlled timer generates a square-wave signal that drives the speaker. Hence any drive frequency has harmonic components and generates no “pure tones.” Applicable standards recommend against the use of pure tones in alarm situations to reduce the risk of an individual with a “notch” hearing deficit missing an alarm.

4-1

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MEDRAD Veris 8600

ECG Module

The patient module receives the physiological ECG data from the patient as either a 5- or 3-lead format (user selectable; a 5-lead placement can be viewed as either 3-lead or 5-lead). The module receives the ECG data along with the gradient and RF noise generated by the scanner. This information is converted to a pulse width modulated light signal which is sent over a fiber optic cable to the main monitor. The monitor converts the light signal to an electronic signal. At that point the information is processed to remove the noise from the ECG signal. The ECG signal is forwarded to the monitor in a format that is capable of being received for processing for display on the monitor screen. Also at this point the ECG signal is made available as a gating signal to the scanner in both a waveform and a pulse.

Pulse Oximeter Module (SpO2)

The method of measuring the oxygen saturation is spectrophotometry and plethysmography. The sensor is made up of a dual emitter and a detector. The emitter and detector are remote from the patient by a length of optical fibers which remove the electronic components from the patient area. The sensor emits two wavelengths of light: red and infrared. The photodetector measures the intensity of the two wavelengths that pass through the measuring site unabsorbed. The resultant signal is converted to an electrical signal and returned to the monitor where the information is processed and displayed for the user to view.

Capnometer Module (CO2)

The optional capnometer (Anesthetic models only) contains the circuitry for monitoring the sidestream CO2 level by actively sampling from the patient’s airway. It contains provisions for interfacing with galvanic oxygen monitoring option sub-modules. No electrical connection is made with the patient from the monitor for capnometry. The CONM module controls the capnometer. The CO2 Board contains an assembly known as a “bench.” This bench contains the optics, IR source, detector, sample cell, and optical filters. The purpose of this bench is to convert CO2 levels in a gas sample to electrical signals. The bench assembly utilizes the principle of infrared absorption spectrometry to measure the amount of CO2 in patients breath. Infrared absorption spectrometry is widely used in gas analysis. Using a phenomenon explained in “Beers Law,” CO2 gas absorbs certain wavelengths of infrared energy with the amount depending on the amount of CO2 gas. A detector, outfitted with an infrared bandpass filter, only allows a certain wavelength of infrared energy that the CO2 gas absorbs. As the CO2 concentrations in the sampled air passes through the sample cell, the detector senses the infrared energy changes and converts them to an electrical signal. This electrical signal is then amplified and conditioned and sent to a microprocessor for processing and then sent to a display.

4-2

MEDRAD

Vital Signs Monitor

Veris 8600 Service Manual Rev 0 Sept 2005