Veris 8600 Operation Manual Rev 9 Feb 2007

Veris 8600 Operation Manual TM

Copyright 2005-2007, 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

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Contents Contents... iii In Case of Emergency Contact ...xi CE Contact ...xi MEDRAD Subsidiaries...xi International Offices...xi Symbols ... xiii Regulatory Symbols... xiii Safety Symbols... xiii System Symbols ... xiv Port Symbols ... xiv Miscellaneous Symbols ...xv Safety ... xvi Definitions ... xvi Warnings... xvi Cautions... xviii Introduction ... xxii Description... xxii Intended Use ... xxii Clinical Use... xxiii

Section 1 - Panel Features Front Panel ... 1-1 Menu Knob... 1-2 Color Display... 1-2 Water Trap and Gas Sampling Connection ... 1-2 Left Side Panel (Main Monitor) ... 1-3 Communication Port (Main Monitor) ... 1-4 Main Monitor Base Connections ... 1-5 Chassis Ground ... 1-5 DC Connection... 1-5 Exhaust Port... 1-5 Air Intake Port ... 1-5 Remote Display Connections... 1-6 Communication Ports (Remote Display) ... 1-7 Printer ... 1-8 Accessory Tray ... 1-8 Veris 8600 Configurations... 1-9

Section 2 - Monitor Setup Battery Power ... 2-1 Charging the Battery ... 2-1 Battery Indicators ... 2-2 System Start and Auto-calibration ... 2-3 Sensor and Probe Messages... 2-4 Capnography (CO2) Startup... 2-4 Agent Gas Startup... 2-4 Gas Calibration ... 2-4

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MEDRAD Veris 8600

Screen Display and Interface ...2-5 Waveform Slots ...2-6 Numerical Parameter Boxes...2-9 Main Menu...2-11 Alarm and Message Areas ...2-12 System Status Box ...2-12 Patient Information and Clock ...2-12 Keypad ...2-13 Softkey Functions (Main Menu)...2-15 Changing Settings ...2-15 Saved Setting Profiles ...2-16 ALARMS Softkey...2-17 Primary ALARMS Window...2-18 Invasive Blood Pressure Alarm Settings ...2-19 Agent Gas Alarms ...2-20 PARAMS Softkey (Physiological Parameters) ...2-22 Primary PARAMS Window ...2-22 SpO2, Respiration, Temperature Menu ...2-26 Gas Settings ...2-27 DISPLAY Softkey ...2-29 Waveform Description ...2-29 Double Height Slots...2-30 Cascaded Slots ...2-31 Gain and Sweep ...2-32 ADM/DIS Softkey (Admit/Discharge)...2-33 Admitting and Discharging Patients...2-33 Adult/Pediatric/Neonatal (Patient Size) ...2-34 Patient Information ...2-34 Procedure for Admitting a Patient...2-35 Procedure for Discharging a Patient...2-35 CONFIG Softkey (System Configuration)...2-36 Password Protection...2-37 Date Format...2-37 Time/Date Setting...2-37 Freeze Timeout ...2-37 Standby Timeout ...2-37 Standby Tone ...2-37 Alarm Tone Warning...2-37 Print Device ...2-38 Language Settings...2-38 PRINT Softkey...2-39 Default Settings ...2-40 Factory Defaults ...2-40

Section 3 - Alarms and Messages Alarm Description ...3-1 Remote Display Alarms ...3-1 Audible Alarms ...3-1 Visible Alarms...3-2 Waveforms Frozen ...3-2 Alert Icons...3-3

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Contents

Special Alarm Conditions... 3-3 Alarms at Start Up... 3-3 Alarm Silence ... 3-3 Alarms tone warning (Warning Tone) ... 3-4 Alarm Volume... 3-4 Minimum Volume Auto-Reset ... 3-4 Standby Mode ... 3-5 Alarm Standby Mode... 3-5 Standby Mode Timeout ... 3-5 SpO2 Low Limit Auto-Reset ... 3-5 SpO2 Low Limit Off Alarm ... 3-5 Triggering an Alarm ... 3-6 Alarms Testing ... 3-6 Alarm Message List ... 3-7 Shared Source Alarms ... 3-7 ECG Alarms ... 3-7 SpO2 Alarms ... 3-7 Temperature Alarms ... 3-8 NIBP Alarms... 3-9 IBP Alarms ... 3-10 Capnometry (CO2) Alarms and Messages... 3-11 Agent Gas Alarms and Messages... 3-11 Oxygen Monitoring (O2) Alarms ... 3-13 System Alerts... 3-14

Section 4 - Trends Description ... 4-1 Trend Interval ... 4-1 Capacity ... 4-1 Trend Screen Update... 4-1 Trend Setup ... 4-2 Graphical Trends ... 4-4 Scrolling the Graph ... 4-4 Interruption Due to Power Cycling or Standby Mode ... 4-4 Graphical Trend Display... 4-5 Tabular Trends... 4-6 Tabular Trend Markers... 4-6 Trend Messages ... 4-6 Data Format ... 4-7 Clearing the Memory... 4-10

Section 5 - ECG Theory of Operation ... 5-1 Heart Rate... 5-1 ECG Measurement ... 5-1 ECG Module... 5-2 Gating Signals... 5-2 ECG Waveform Size ... 5-2 ECG Monitoring (Electrocardiogram)... 5-3 Protection ... 5-5 ECG Performance... 5-5 Sudden Changes In Heart Rate ... 5-5 ECG Filters... 5-6 Electrode Selection ... 5-6

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MEDRAD Veris 8600

ECG Module Interface...5-7 ECG Module Ports And Switches...5-7 Battery Condition ...5-8 Charging the Battery...5-9 ECG Monitoring...5-11 Patient Preparation...5-11 Lead Placement...5-12 Connecting Patient to the Monitor ...5-14 Completion of ECG Monitoring...5-15 ECG Auto Lead Switching...5-16 Primary Lead ...5-16 Alternate Lead Priority ...5-17 Gating Interface...5-18

Section 6 - NIBP Theory of Operation ...6-1 Heart Rate ...6-1 Comfort Cuff™ Technology ...6-1 Description of NIBP Measurement ...6-1 NIBP Clinical Testing and Accuracy ...6-1 Cuff Inflation and Pressure Protection...6-2 NIBP Monitoring ...6-3 Selecting Cuffs and Hoses ...6-5 Placing the NIBP Cuff...6-6 Procedure...6-7 Taking NIBP Measurements ...6-8

Section 7 - Pulse Oximetry (SpO2) Theory of Operation ...7-1 Heart Rate ...7-1 Audible Pulse Beep ...7-1 Definition...7-1 DOX™ Digital Oximetry...7-1 Method...7-1 Data Update Period ...7-2 SpO2 Clinical Testing and Accuracy...7-2 Gating Signals ...7-3 SpO2 Monitoring Procedures (Pulse Oximetry)...7-4 SpO2 Clip Probes ...7-5 Attaching the Clip Probe to the Monitor...7-5 Attaching the Clip Probe to the Patient...7-6 Finger Probe Application ...7-7 SpO2 Flexible Grip Probes ...7-8 Attaching the Flexible Grip Probe to the Monitor...7-9 Attaching the Flexible Grip Probe to the Patient...7-10 Finger/Toe Flexible Grip Probe Application...7-11 Neonate Foot Flexible Grip Probe Application: ...7-12 SpO2 Peripheral Gating ...7-13

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Contents

Section 8 - IBP Theory of Operation ... 8-1 Heart Rate... 8-1 Method of Measurement ... 8-1 IBP Clinical Testing and Accuracy ... 8-1 IBP Monitoring ... 8-2 Invasive Blood Pressure Transducers and Interface Cables ... 8-3 Approved Transducers... 8-3 Transducer Placement Gauss Limits ... 8-3 IBP Interface Cables ... 8-4 IBP Monitoring Procedure... 8-5 IBP Safety ... 8-6 Setup and User Calibration ... 8-6 Zero Calibration (Quick) ... 8-8 Clinical Use and Arterial Waveforms... 8-9

Section 9 - Temperature Theory of Operation ... 9-1 Temperature Monitoring Procedures ... 9-2 Directions for Use with Skin Surface Probe ... 9-4 Preparing the Equipment ... 9-4 Attaching the Temperature Probe to the Patient... 9-4 Cleaning Probes ... 9-4

Section 10 - Anesthetic Agents Theory of Operations ... 10-1 Integrated CO2 and Agent Gas Detector ... 10-1 Agent Gas Measurement ... 10-1 Gas Monitoring Procedures ... 10-3 Sampling Circuit Connections ... 10-3 Gas Monitoring Safety... 10-4 Water Trap ... 10-5 Gas Sampling Devices... 10-6 Intubated Patients ... 10-6 Calibration and Startup ... 10-7 Procedure for Gas Monitoring ... 10-8 Occlusions... 10-8 Anesthetic Gas Exhaust Recovery... 10-8

Section 11 - CO2, O2, and N2O Theory of Operation ... 11-1 Respiration ... 11-1 Capnometry (Measurement of CO2) ... 11-1 Measuring Oxygen (O2) ... 11-2 CO2 Monitoring Procedure... 11-4 O2 Monitoring Procedures ... 11-5 Interfering Gasses for O2 ... 11-5 N2O Monitoring ... 11-5

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MEDRAD Veris 8600

Section 12 - Printing and Data Ports Description ...12-1 Snapshot Size ...12-1 History Size ...12-1 Safety ...12-1 Print Modes ...12-2 Demand Print...12-2 Continuous Print ...12-2 Alarm Print...12-2 BP Print ...12-2 Interval Print ...12-2 Freeze Print ...12-3 Trend Print...12-3 Print Formats...12-4 Tabular Printing ...12-4 Graphical Printing ...12-4 Changing Printer Paper...12-7 Data Output Ports...12-9 COM1 Port...12-9 Serial Printing ...12-10 Sending Data to a Computer ...12-10 External Serial Printer Accessory ...12-13 COM2 Port...12-14 Video Port...12-14 CSV Data Format ...12-15

Appendix A: Maintenance Cleaning and Disinfecting... A-1 Pulse Oximeter Sensors... A-2 Blood Pressure Cuffs... A-2 Temperature ... A-3 Accidental Wetting... A-4 Annual Safety Tests ... A-5 System Testing... A-5 Service Checks... A-5 Maintenance Schedule... A-6 Long-Term Storage ... A-7 Disposal... A-7

Appendix B: Unit and Configuration Defaults Restoring the Unit Default Profile ... B-1 Default Settings ... B-1 Unit Default Settings... B-1 Configuration Default Settings... B-3 Configuration Settings for Unit Defaults ... B-5 PARAMS Menu Settings ... B-5 PRINT Menu Settings... B-6 DISPLAY Menu Settings ... B-6 ALARMS Menu Settings... B-7 Other Alarm Settings ... B-10

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Contents

Appendix C: Specifications ECG ...C-1 ECG System ...C-1 ECG Module...C-1 Leadset ...C-1 ECG Module Charger...C-2 Heart Rate...C-2 NIBP...C-2 SpO2 ...C-2 Invasive Blood Pressure ...C-3 Transducer ...C-3 Gating ...C-3 Temperature ...C-3 Halogenated Agents ...C-4 Capnometry (CO2) ...C-5 CO2 Respiration...C-5 Oxygen Monitoring (O2) ...C-5 Nitrous Oxide (N2O)...C-6 Pneumatics ...C-6 Alarms...C-6 Audible Volume Adjustment Range of High Priority Alarms...C-6 High Priority Average Sound Pressure ...C-6 Trend Reports ...C-7 Printer (Remote Display only) ...C-7 Controls...C-7 System Outputs (Remote Display Only) ...C-7 Environmental ...C-7 Mechanical/Electrical ...C-8 Power Supply ...C-8 Remote Display...C-8 Main Monitor ...C-9

Appendix D: Accessories ECG Accessories...D-1 ECG Module...D-1 ECG Electrode Accessories...D-1 ECG Gating Accessories ...D-1 SpO2 Accessories...D-1 SpO2 Probes ...D-1 SpO2 Peripheral Gating Accessories ...D-1 NIBP Accessories ...D-2 Reusable Cuffs...D-2 Disposable Cuffs ...D-2 IBP Accessories...D-2 Temperature Accessories ...D-2 Agent Accessories ...D-3 Miscellaneous Accessories...D-3 Publications...D-3 Operation Manuals...D-3 Help Cards ...D-4 Installation and Service ...D-4

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MEDRAD Veris 8600

Appendix E: Troubleshooting General Troubleshooting... E-1 Troubleshooting Table... E-1

Appendix F: IBP Transducer Specifications IBP Specifications...F-1 Transducer Specifications ...F-1 Transducer Cables ...F-1 Compliance...F-1 Defibrillation Protection...F-1 High Frequency Interference ...F-2

Appendix G: Fiber Optic Communication Fiber Optic Network Communication Interface... G-1 Operation... G-1

Appendix H: Battery and Fuse Specifications Battery Specifications... H-1 Main Monitor Batteries... H-1 Fuse Specifications ... H-2 Remote Display Fuses ... H-2 Main Monitor Fuses ... H-2 Power Supply Fuses... H-2 Fuse Removal/Replacement ... H-3 Remote Display ... H-3 Power Supply ... H-4

Appendix I: Wireless Communication Wireless Network Communication Interface ...I-1 Specifications ...I-1 Regulatory ...I-1 RF Devices ...I-1 Operation / Performance ...I-2 Safety ...I-6 Troubleshooting...I-7

Appendix J: Electromagnetic Compliance

Appendix K: Serial Data Output CSV Header ... K-1 CSV Data ... K-1 Data Definitions ... K-2 Text Header... K-4 Text Data... K-4

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In Case of Emergency Contact 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

CE Contact

EC REP MEDRAD Subsidiaries

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) 43-3585601 FAX: +31 (0) 43-3656598 (Visiting MEBV address:) Horsterweg 24 6199 AC Maastricht Airport The Netherlands

International Offices

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

(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

MEDRAD do Brasil Ltda. Mediwest Denmark ApS Av. Nove de Julho, 5109-11 o andar Naverland 2 Jardim Paulista 2600 Glostrup Cep. 01407-200 Denmark São Paulo - SP Telephone: +45 38-16 16 16 Brasil FAX: +45 38-16 16 46 Telephone: + 55 11 3702-6000 FAX: + 55 11 3078-4026 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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Symbols Symbol

Definition European Community Mark

Regulatory Symbols

ETL Mark FCC (US Federal Communications Commission) Mark Safety Symbols

ATTENTION! Refer to Operation Manual for Information 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 Protective Earth 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

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) Dispose of batteries properly in accordance with hospital and local regulations. For pulse oximeter probes: Do not dispose. Pulse oximeter probes are intended for multiple use. Risk of electrical shock! Do not remove cover. Refer servicing to qualified personnel.

System Symbols

Fuse Alternating Current (AC) Direct Current (DC) Wireless Device

Port Symbols

Signal Input Signal Output

IOIOI

Digital Output Air Intake Scavenging Port Communication Port Video Out

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Symbols

Miscellaneous Symbols

Symbol

Definition Technical Support Phone Number Manufacturing Contact

SN REF

Serial Number Part Reference Number

Place this side against the skin (Blood Pressure Cuff) Placement of the cuff over the brachial artery.

2

Single use device only. Do not reuse.

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Safety Definitions

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

Designates a possible dangerous situation. Nonobservance may lead to death or the most severe injuries.

! CAUTION !

Designates a possible dangerous situation. Nonobservance may lead to minor injuries or damage to the product.

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 rich environment, such as 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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Safety

! 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. • Apply brakes to prevent movement. • Do not re-use accessories labeled as single use. Risk of patient contamination may occur. • 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.

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MEDRAD Veris 8600

! WARNING !

• Do not stand on the power supply enclosure. Injury from tripping or falling can occur. • 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. • Use with Open MRI may cause image artifacts. Test monitor with phantom in MRI prior to patient use to ensure image quality. • Use with Open MRI may cause inaccurate readings or unavailable monitoring. Observe Gauss Limit restrictions for Monitor placement (Refer to “Potential Interference” on page xx for details). • Do not stand or sit on monitor accessories tray. Possible injury can result from falling. • Do not lift the monitoring system by the tray. Possible injury can result from heavy weight. • 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 IEC 60601-1-2 specified levels for emissions of and immunity to electrical interference. External disturbances which exceed these levels, such as motor driven tools, 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 or any other cable through the magnet room door. Possible damage can occur to the cable(s) 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.

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Safety

! CAUTION !

• 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. • 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). • 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. • Do not bend fiber optic cables too tightly. See “Specifications” in Appendix C for proper bending of fiber optic cables. • 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.

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MEDRAD Veris 8600

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. 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 Capnography or Anesthesia monitors at or outside of the 500 Gauss line. This monitor is designed specifically for MR compatibility and is 1.5 and 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.

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Safety

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. OTHER INTERFERENCE

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

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

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” on page A-1. 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 interference 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

Disposal Accessory Disposal

Latex Content

The amplitude of the audible pulse tone remains constant regardless of changes in patient parameter measurements. Discard disposable medical waste according to your institution's policies and procedures to prevent biological contamination. See “Disposal” on page A-7. This MEDRAD product (patient monitors and approved accessories) is free from latex in any location that may result in patient contact.

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