Veris 8600 Service Manual Rev 0 Sept 2005

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

iii

Medrad Veris 8600

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

iv

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

v

Medrad Veris 8600

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

VIEWED/PRINTED: 11/09/2005 at 03:09:15. 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.

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

1-1

MEDRAD Veris 8600

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

1-2

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

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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.

1-3

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.

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

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.

1-4

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

Electromagnetic environment - guidance

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.

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.

Voltage fluctuations/flicker emissions IEC 61000-3-3

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

+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

+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

+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

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

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

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

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

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

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

3 A/m

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.

1-5

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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

p

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.

1-6

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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.

1-7

MEDRAD Veris 8600

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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)

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.

Direct Current (DC) Wireless Product Port Symbols

Signal Input Signal Output

IOIOI

Digital Output Air Intake Scavenging Port Communication Port Video Out

1-8

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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)

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.

Placement of the cuff over the brachial artery.

2

Single use device only. Do not reuse.

1-9

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

MEDRAD Veris 8600

Definition of Warnings and Cautions

Definitions for Warning, Caution, and Note symbols: ! DANGER !

Designates an imminent danger. Non-observance is likely to lead to death or the most severe injuries.

! 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.

1-10

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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.

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.

• 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.

1-11

VIEWED/PRINTED: 11/09/2005 at 03:09:15.

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.

1-12