Veris 8600 Vital Signs Monitor Operations Manual Aug 2005 PDF download

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Veris 8600 Vital Signs Monitor TM

Operation Manual

3010796 Revision 2 Date 05/05

Page i

Veris 8600 Operation Manual

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TM

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

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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

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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 Gas Calibration .................................................................................................. 2-4 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

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MEDRAD Veris 8600

Softkey Functions (Main Menu)................................................................................... 2-14 Changing Settings ............................................................................................ 2-14 Saved Setting Profiles ...................................................................................... 2-15 ALARMS Softkey......................................................................................................... 2-16 Primary ALARMS Window................................................................................ 2-17 Invasive Blood Pressure Alarm Settings ..........................................................2-18 Agent Gas Alarms ............................................................................................ 2-19 PARAMS Softkey (Physiological Parameters) ............................................................ 2-21 Primary PARAMS Window ...............................................................................2-21 SpO2, Respiration, Temperature Menu ............................................................ 2-25 Gas Settings ..................................................................................................... 2-26 DISPLAY Softkey ........................................................................................................ 2-28 Waveform Description ...................................................................................... 2-28 Double Height Slots.......................................................................................... 2-29 Cascaded Slots ................................................................................................2-30 Gain and Sweep ............................................................................................... 2-31 ADM/DIS Softkey (Admit/Discharge)...........................................................................2-32 Admitting and Discharging Patients.................................................................. 2-32 Adult/Pediatric/Neonatal (Patient Size) ............................................................ 2-33 Patient Information ........................................................................................... 2-33 Procedure for Admitting a Patient..................................................................... 2-34 Procedure for Discharging a Patient................................................................. 2-34 CONFIG Softkey (System Configuration).................................................................... 2-35 Password Protection......................................................................................... 2-36 Date Format...................................................................................................... 2-36 Time/Date Setting............................................................................................. 2-36 Freeze Timeout ................................................................................................2-36 Standby Timeout .............................................................................................. 2-36 Standby Tone ................................................................................................... 2-36 Alarm Tone Warning......................................................................................... 2-36 Print Device ...................................................................................................... 2-36 Language Settings............................................................................................ 2-37 PRINT Softkey............................................................................................................. 2-38 Default Settings ........................................................................................................... 2-39 Factory Defaults ............................................................................................... 2-39

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 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 Agent 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

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Contents

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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 Electrode Selection ............................................................................................ 5-6 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

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MEDRAD Veris 8600

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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 - SpO2 Theory of Operation ...................................................................................................... 7-1 Heart Rate .......................................................................................................... 7-1 Definition............................................................................................................. 7-1 DOX™ Digital Oximetry...................................................................................... 7-1 Method................................................................................................................ 7-1 SpO2 Clinical Testing and Accuracy................................................................... 7-2 Gating Signals .................................................................................................... 7-2 SpO2 Monitoring Procedures (Pulse Oximetry)............................................................. 7-3 Attaching the Probe to the Monitor................................................................................ 7-4 Attaching the Probe to the Patient................................................................................. 7-4 Finger Probe Application for Adults .................................................................... 7-6 Neonate Probe Placement ................................................................................. 7-7 SpO2 Peripheral Gating .............................................................................................. 7-10

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 IBP Interface Cable ............................................................................................ 8-3 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

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Contents

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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 ........................................................................................ 10-2 Sampling Circuit Connections .......................................................................... 10-2 Gas Monitoring Safety...................................................................................... 10-3 Water Trap ....................................................................................................... 10-4 Sampling Devices ............................................................................................ 10-5 Intubated Patients ............................................................................................ 10-5 Calibration and Startup .................................................................................... 10-6 Procedure for Gas Monitoring .......................................................................... 10-7 Occlusions........................................................................................................ 10-7 Anesthetic Gas Exhaust Recovery................................................................... 10-7

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

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 COM2 Port ..................................................................................................... 12-11 Video Port ................................................................................................................. 12-11 CSV Data Format...................................................................................................... 12-12

Appendix A: Maintenance

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MEDRAD Veris 8600

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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-11

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 Trend Reports .............................................................................................................. C-6 Printer (Remote Display only) ...................................................................................... C-6 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

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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-2 Miscellaneous Accessories...........................................................................................D-3 Publications...................................................................................................................D-3 Operation Manuals.............................................................................................D-3 Help Cards .........................................................................................................D-3 Installation and Service ......................................................................................D-3

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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

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MEDRAD Veris 8600

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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

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

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

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

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

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. 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 Veris 8600

MEDRAD France S.a.r.l. 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

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

MEDRAD Italia S.r.l.

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

Via Togliatti, 111 27051 Cava Manara (PV) Italy Telephone: +39 (0) 382 552882 FAX: +39 (0) 382 552876 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 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

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

Definition European Community Mark

Regulatory Symbols

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

ATTENTION! Refer to Operation Manual for Information Shock Hazard

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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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Symbol

Definition Dispose of batteries properly in accordance with hospital and local regulations. Risk of electrical shock! Do not remove cover. Refer servicing to qualified personnel. Fuse

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System Symbols

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

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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

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SN REF

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

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Serial Number

Single use device only. Do not reuse.

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Safety

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Definitions

Definitions for Warning, Caution, and Note symbols: !

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.

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 !

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• 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 !

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• 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.

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• 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 lift the monitoring system by the tray. Possible injury can result from heavy weight.

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• 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. • 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.

xviii

Safety

!

CAUTION !

• 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.

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• 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.

xix

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.

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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

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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 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.

xx

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

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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

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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” 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 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

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.

xxi

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Introduction Description

The VerisTM 8600 patient monitor is designed for use in the MRI environment. It interprets and displays physiologic data as waveforms and numeric information which, depending on the configuration of the system, may include ECG, NIBP, SpO2, CO2, respiration, temperature, O2, anesthetic gases, and IBP. User defined alarm limits and alerts may be set for each parameter. Monitored parameter data is stored as tabular trend information and may be printed or downloaded.

Intended Use

The system is intended to monitor physiological parameters of patients within any health care environment, specifically in the MR environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.

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The monitor is MR compatible based on the FDA guidelines for equipment to be used in MR. There are two distinct needs for patient monitors in MR: • Vital signs monitoring, to monitor medically unstable patients or patients under conscious sedation, as required by the JCAHO. • And, provide image gating, to gate image acquisition to a physiological parameter, such as the cardiac cycle. There is the additional requirement for the accurate function of the equipment in the MR environment. The monitor used in the scan room shall not be affected by the radio frequency pulse or gradient fields and shall not produce any RF interference on the image. The monitor (including accessories) is capable of monitoring a full range of patients from neonate to adult.

xxii

Introduction

Clinical Use

This manual provides separate sections for measured parameters. These sections provide instructions for patient connections and monitoring. The caregiver is expected to be fully familiar with patient monitoring techniques and with the functions of this monitor before using it with a patient.

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This system is designed to only monitor one patient at a time per monitoring system. Before you Begin

Protect yourself and your patient. Read the precautions for each measured parameter that appears in each measured parameter section. These instructions describe the use of the basic sampling devices and accessories that come with your monitor. An extended list of approved accessories can be found in “Accessories” in Appendix D of this manual. The monitor should always be checked by the caregiver before use for actual patient monitoring. Perform the following procedure before using the monitor with each patient. 1. Make sure the monitor has been fully charged before use. Check that the AC (Mains) power cord is plugged in for longterm monitoring situations. 2. Check the menus and default settings to confirm that the monitor is setup correctly. 3. Examine the accessories for wear, damage, or contamination. Replace or disinfect the accessories as required. 4. Turn the desired monitoring modules to ON in the PARAMS softkey window. 5. Select the correct mode of operation (Adult/Pediatric/Neonate) by entering the patient size in the ADM/DIS softkey window.

!

CAUTION !

• All accessories connected to the patient monitor must comply with all applicable UL (Underwriters Laboratories) standards and IEC standards for such products. • Substitution of recommended sensor and sampling accessories may cause inaccurate measurements and degrade patient safety, or may damage the monitor.

xxiii

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1 — Panel Features This section provides an overview of the Veris 8600 monitor’s control panels, switches, accessory connections, and communication sockets.

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Front Panel

The front panels of the monitor and the optional remote display feature a color flat-screen display. Located below the screen is the primary control panel equipped with the power button, eight dedicated function keys and a menu knob. Menu selections are displayed on the screen and can be selected via the menu knob. The keypad is push-button style, composed of a touch-sensitive membrane. The water trap receptacle is also located on the front of the main monitor (Anesthesia units only). Color Display

Water Trap Receptacle (Anesthesia Monitors only)

Power Switch

Keypad

Menu Knob

Figure 1-1: Veris 8600 Front Controls

1 —1

MEDRAD Veris 8600

A green LED indicator is located above the power (ON/OFF) key. The indicator is on if AC power is present.

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Sampling Line AC Power Connection Indicator

Water Trap

Function Keys

Menu Knob

Figure 1-2: Detail of Lower Front Panel

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Menu Knob

Color Display

Water Trap and Gas Sampling Connection

The menu knob can be turned left or right to make selections from any of the menus that appear on the front display. The selected menu option can then be activated by pressing in on the menu knob. The display provides real-time waveform and numerical data of the measured parameters. Additional menus and menu options which may be selected and activated by the menu knob are also displayed on this and the optional remote display screen. The water trap connection is a feature on Anesthesia and Anesthesia with Temperature models only. MEDRAD Veris monitors without gas analysis capability have a blank plate in this location. The water trap is easily accessed on the front of the monitor. The gas sampling line is connected to the water trap and it is used for CO2, O2, N2O, and agent monitoring. The sample line fitting is a standard female Luerlock connector when using the WaterChek™2+ water trap accessory.

1 —2

1 —Panel Features

Left Side Panel (Main Monitor)

The left side of the main monitor has up to nine connections for patient monitoring. The electrocardiogram (ECG), pulse oximetry (SpO2), and the non-invasive blood pressure (NIBP) connections are standard on all Veris 8600 models. All potential Veris main monitor connections are described in the picture below.

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The optional remote display has no patient connections. More information about accessory connections can be found in the patient monitoring sections of this manual. ECG Input/ Output Temperature Gating Signal

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SpO2 IBP

NIBP

Figure 1-3: Veris 8600 Left Side

1 —3

MEDRAD Veris 8600

Communication Port (Main Monitor)

There are two fiber optic ports at the bottom of the monitor. One is an input port and the other an output port. These ports, on both the main monitor and the remote display, are for fiber optic communication between the main monitor and the remote display. See the Installation Instructions for installing the fiber optic communications.

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See “Figure 1-8: Remote Display Fiber Optic Connections” on page 1-7 for the location of the fiber optic ports on the remote display. NOTES: These connections have protective covers that need to be removed before use. Do not use any other communication connectors on the main monitor. These are for service use only.

Fiber Optic Input and Output Connectors

Figure 1-4: Main Monitor Fiber Optic Connections

1 —4

1 —Panel Features

Main Monitor Base Connections DC Connection

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Exhaust Port

Air Intake Port

DC Connection & Exhaust Port Figure 1-5: Main Monitor Base Connections Chassis Ground DC Connection

The Veris monitor has an internal chassis ground. A DC power cable connection is located at the center of the base of the patient monitor. Attach the cable from the power supply in this socket. !

CAUTION !

• Ensure that the cable from the power source to the monitor base is placed in an area free from traffic to prevent tripping and/or damage to the cable. Exhaust Port

The exhaust port is located on the base of the Anesthesia monitor assembly by the DC connection. The scavenging kit fits this nozzle. Use the scavenging kit and a waste gas recovery system when anesthetic agents are present in gas samples.

Air Intake Port

An ambient air intake port (located next to the exhaust port on the base of the Anesthesia monitor assembly) is used for making zero gas concentration calibrations. Do not block or attach anything to the air intake port.

1 —5

MEDRAD Veris 8600

Remote Display Connections

The remote display displays the patient data in another location. Changes to the display can be made from the remote display and be effected on the patient monitor. Printer Feed Advance

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Printer Release Lever

Printer Door

Service Access Panel Fuse Access Panel

Communication Connections

Chassis Ground

AC Power Connection

Figure 1-6: Remote Display Rear View

1 —6

1 —Panel Features

Communication Ports (Remote Display)

There are three communications sockets available along the back edge of the remote display. These connections provide links to external printers, computers, and other medical devices. See “Printing and Data Ports” in Section 12 for more information about serial printing and communications

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COM Port 1 Serial DB-9 COM Port 2 Mini DIN 8 Not Used

Video Port

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Not Used

Figure 1-7: Communication Ports (Remote Display) There are also two fiber optic ports on the right side of the remote display. These ports, on both the main monitor and the remote display, are for fiber optic communication between the main monitor and the remote display. See the Installation Instructions for installing the fiber optic communications. NOTE: These connections have protective covers that need to be removed before use.

Fiber Optic Input and Output Connectors

Figure 1-8: Remote Display Fiber Optic Connections

1 —7

MEDRAD Veris 8600

Printer

This printer door provides quick access to the internal printer paper spool. The printer lever releases the printer rollers for removing jammed paper. The knob can be turned to feed paper. See “Printing and Data Ports” in Section 12 for additional printer information. Printers are only available on Veris 8600 remote displays.

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Accessory Tray

The monitor has an integral accessories tray where the user can store and hang accessories.

!

WARNING !

• 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.

!

CAUTION !

• Do not place more than 40 pounds (18 kg) on the tray.

Figure 1-9: Accessory Tray

1 —8

1 —Panel Features

Veris 8600 Configurations

There are six factory-set configurations and one optional remote display available. See below for configuration options. Number

Description

Features

3011991 Base MR Monitor

Standard 3-lead ECG, SpO2, and NIBP

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3011992 BasePlus MR Monitor 3011993 Cardiology configuration

3011994 3011995

3011996 3010482

Base plus Remote Display Base plus 5-lead ECG, ECG Gating, SpO2 Gating, IBP. The Remote Display is optional. Cardiology with Temperature Cardiology plus Temperature. The Remote Display is optional. Anesthesia configuration Base plus 5-lead ECG, ECG Gating, SpO2 Gating, IBP, O2, CO2, N2O, agents. The Remote Display is optional. Anesthesia with Temperature Anesthesia plus Temperature. The Remote Display is optional. Remote Display Remote display with printer and fiber optic communications.

The instructions in this manual cover the operation of each of the option packages listed above. For those models that do not include a particular monitoring module (i.e. Agents), the system functions as if that module is turned off.

1 —9

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2 — Monitor Setup This section provides an overview of the setup procedures for the Veris 8600 monitor. Also see the appropriate chapters on patient parameter monitoring for parameter setup information.

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The monitor should be set up by the health care provider before using it on patients: • Load paper (if remote display is present). See paper loading instructions in “Changing Printer Paper” on page 12-7. • Charge all batteries (ECG module battery, main monitor batteries.) Preparations such as charging the batteries should be performed if the monitor is new. Battery Power

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Charging the Battery

The monitor base contains two lead-acid gel batteries that when fully charged provide a minimum of ten hours of operational use. The Veris monitor is battery powered. The monitor internally recharges the battery when it is connected to the power supply. The monitor can operate in continuous use for a minimum of 10 hours on a fully charged battery. Charge the battery from the power supply overnight for approximately 12 hours.

!

WARNING !

• If the electrical integrity of the earth ground is in doubt, the power cord should be disconnected and the machine should be operated from its internal electrical power source. • Explosion hazard. Keep lighted cigarettes, sparks, and flames away from the battery. • Avoid contact with battery acid! The batteries contains sulfuric acid electrolyte which can cause severe burns and eye damage, as well as illness from sulfur oxide fumes. Use necessary precautions when servicing batteries. • Do not short circuit the battery terminals. The resulting highcurrent discharge can cause burns. • Do not operate the monitor with discharged or defective batteries. Monitor failure could occur during AC power loss which can compromise patient safety. • Do not use the monitor if the batteries are missing.

2 —1

MEDRAD Veris 8600

The Veris monitor can function on AC or battery power. MEDRAD recommends that batteries be fully charged at all times. If the batteries are insufficiently charged, battery life is degraded and shortened. If defective batteries are suspected, contact MEDRAD Service or your local representative.

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Battery Indicators

The battery icons are located on the lower portion of the main screen as described in “Screen Display and Interface” on page 2-5. The battery icons change color to indicate the status of the batteries and appear when using DC (battery) or AC (Mains) power. When AC is connected to the monitor (green light above ON/OFF key is lit), the battery icon colors are: Amber:

Battery is charging.

Green:

Battery is fully charged or not present.

When AC is not connected to the monitor (green light above ON/OFF key is not lit), the battery icon colors are: Green:

Battery life is greater than 1 hour.

Yellow:

Battery is weak. (less than 1 hour and more than 15 minutes of charge remains). A LOW BAT message also appears.

Black:

Battery is nearly drained. (less than 15 minutes of charge remain). The LOW BAT message remains.

While using battery power there is a short delay between a change in battery status and the updated display of the battery icons. If the monitor is currently operating under AC power, the monitor may take up to two minutes to display a change in battery status. The monitor also displays the battery status for the ECG module in the heart rate (HR) parameter box. The battery icon colors are: Green:

Battery life is greater than seven (7) hours.

Yellow:

Battery life is less than seven (7) hours. Charge the module battery soon

Black:

This can indicate the ECG module is not connected to the monitor. Verify the module is connected to the monitor. If the ECG module is connected, verify that the module is turned on. If the module is connected to the monitor and turned on, the battery is drained. ECG module will not operate. Charge the module battery immediately.

2 —2

2 —Monitor Setup

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System Start and Auto-calibration

To power up the main monitor, press the ON/OFF key located on the front, left side of the control panel. If your system has a remote display, power is applied via the same key on that component.

ON/OFF Key

Figure 2-1: ON/OFF Key MAIN MONITOR

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Immediately upon power up, the Veris monitor displays the Veris splash screen. The software version appears on the screen. OPTIONAL REMOTE DISPLAY

Immediately upon power up, the optional Veris remote display displays the Veris splash screen. The software version appears on the screen. A paper feed also automatically activates. • Audible alarms are suspended for each parameter until the first valid measurement has been taken for each parameter. Visual alerts are always active. • If a patient had been previously admitted by the monitor, a notice message RESUME MONITORING appears in a yellow box. Press the knob to continue monitoring with the current patient. Select NO to change the patient. HR

1mV II

BPM

--- %

ECG

x1 1mV aVR

SpO2

Resume Monitoring

x2

CO2

SpO2

--

EXP

Same patient? YES

RESP

Br/m

-150 ml/min

x1

INS

CO2

GAS

O2

200 ART1 0 20 CVP2 0 T1

%

17 0.4 1.1 21 2.3 3.8

--.--.-

%

ISO

mmHg

IBP1 ART

---/---

(---)

MAP CYCLE OFF SPO2: SENSOR ALARMS PARAMS DISPLAY ZERO IP1 V000 - NO ADMIT ZERO IP2 - + - + Adult ADM/DIS CONFIG PRINT

T2

HAL

---/---

(---)

IBP2

CVP

mmHg

-14:12:59

Figure 2-2: “Resume Monitoring” Dialogue Box

2 —3

MEDRAD Veris 8600

The monitor is comprised of a number of modules which measure physiologic parameters. Some modules such as the oximeter are ready for use within seconds of power up. Others such as the gas bench take a few minutes to equilibrate.

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Sensor and Probe Messages

Depending on the accessories attached to the monitor upon start up, various messages concerning detached sensors and probes appear. These are only visual alarms until valid measurements are taken by the accessories, after which a low level alarm sounds when the sensors and probes are disconnected. NOTE: ECG LEADS OFF messages can be set by the user to be Low, Medium, or High level alarms. If sensor and probe messages from unused modules become a distraction, these messages may be eliminated by turning the respective module off. The OFF settings are located in the PARAMS windows described in “PARAMS Softkey (Physiological Parameters)” on page 2-21. Units with invasive blood pressure capability indicate that either there is no transducer attached (NO XDUCER) or that the transducer has not been calibrated by the user (NOT ZEROED). In either case it is not necessary to attach or zero the transducers in order to use the other features of the monitor.

Gas Calibration

The agent gas detector may require a short warm up period and autocalibration sequence similar to an internal capnometer. The message AGT:WARMING appears in the information message area. The informational message AGT:MANUAL or AGT:AUTOMATIC also appears indicating that the monitor is in either manual or automatic primary agent identification mode. AGT: AUTO CAL indicates that the agent calibration is in progress. Respiration waveforms, capnogram, and numerical breath rate are available in one minute from applying power to the monitor. The monitor reaches full accuracy for agent concentrations in less than 20 minutes. If the Veris system fails to auto-calibrate upon power up, the message AGT:BAD CAL appears. Power cycle the monitor. If the system continues to fail auto-calibration, contact MEDRAD Service or your local representative. The oxygen monitoring module also requires auto-calibration, which is performed at the same time as the agent bench calibration. If the O2 module fails to calibrate, the message O2:SENSOR appears. Upon successfully completing auto-calibration the monitor displays values for monitored gases.

2 —4

2 —Monitor Setup

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Screen Display and Interface

The display is divided into dedicated areas for data and interface functions. The left side of the screen is reserved for waveform (up to six) or graphic display. The uppermost waveform slot is factory set for ECG. The remaining five waveform slots can be configured by the user. The alarm silence icon (2 minutes or permanent) is shown in the upper right corner of the first waveform. The far right column is dedicated to reporting numerical data, except for NIBP and temperature which appear below the waveforms. The color of each parameter is user selectable. A waveform and its corresponding numeric data appear in the same color. Heart Rate Numerical Parameters

Waveform Slot 1

Gating

ECG Module Battery Status

Remote Communication

Waveform Slot 2

Gas Numerical Parameters

Waveform Slot 3

SpO2

Waveform Slot 4 Waveform Slot 5 Waveform Slot 6

CO2 Numerical Parameters

Temperature 1 Temperature 2

Respiration

IBP Channel 1 Parameters NIBP Parameters

ALARMS PARAMS DISPLAY ZERO IP1 ADM/DIS CONFIG PRINT ZERO IP2

Priority Alarms Info Messages System Status

Patient Data

IBP Channel 2 Parameters Date

Time

Figure 2-3: Screen Diagram The main menu is shown in grey above. The arrangement of the numerical parameter boxes varies depending upon the waveforms selected to be viewed and the waveform slot selected for the waveform. The parameter box displays to the right of its corresponding waveform if displayed in a waveform slot. The screen display is the same on the patient monitor and the remote display. Changes to the display can be made at the patient monitor or at the remote display. The bottom portion of the display has space dedicated to the following message types and functions. • The main screen menu of selectable softkeys. • Two message lines for alarms and alerts. • A system status line for battery status and patient size mode. • The patient information bar, date stamp, and clock.

2 —5

MEDRAD Veris 8600

NOTE: Your screen may appear different from below based on waveforms selected and their chosen slots. HR

1mV II

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-+

60

ECG HAL GAS O2 N2O % EXP INS Mixed ENF EXP 10.5 INS 10.0 RESP Br/m SpO2

x1 1mV aVR

17 0.4 21 2.3

x2 SpO2

98

x1

CO2

CO2 200 ART1 0 20 CVP2 0 T1

%

EXP

37

INS

8

39 64

20 200 ml/min

mmHg

IBP1 ART

96.4 97.7

NIBP

AGE

21:13 min

149/106

mmHg

(127)

MAP CYCLE OFF SPO2: SENSOR ALARMS PARAMS DISPLAY ZERO IP1 V000 - NO ADMIT ZERO IP2 + - + - Adult ADM/DIS CONFIG PRINT

T2

BPM

145/105

(125)

IBP2

CVP

mmHg

13 AUG-16-04

14:12:59

Figure 2-4: Sample Interface Screen Waveform Slots

1mV II

x1 1mV aVR

x2 SpO2

x1 CO2 200 ART1 0 20 CVP2 0

The monitor has the capability to display up to six waveforms simultaneously. The first trace is factory set to only display an ECG waveform. The user may select the lead type for this trace. All other displayed waveforms are user selectable. Each waveform slot displays the parameter or source along the left edge of the screen. Amplitude bar and range are shown at the beginning of the slot if applicable to that type of waveform. The color of each waveform may be selected by the user. The waveform slots can be combined to form double high waveforms and waveforms can be cascaded to fill multiple slots. See “Double Height Slots” on page 2-29 and “Cascaded Slots” on page 2-30 for details. NOTE: The SpO2 waveform display is not necessarily directly proportional to pulse volume. The SpO2 waveform display is not automatically gain adjusted.

2 —6

2 —Monitor Setup

VISUAL ALARMS WITH WAVEFORMS

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The waveform slots are also used to display physiological alarms that will appear at the top center of each slot. For a high priority alarm the color of the message is red. For a medium priority alarm, the color of the message is yellow. The bottom five slots may be covered by menus and messages. Since the top waveform slot is dedicated to ECG, the ECG waveform and the ECG high and medium priority messages are always visible if ECG is currently being monitored and the top slot is active. See “Visible Alarms” on page 3-2 for a complete description of visual alarms. SILENCE ALERT STATUS

The silence alert visual icon appears in the upper right area of the top waveform. • The silence icon shows a bell with an "X" and an infinity symbol when the SILENCE hard key has been pressed and held for more than two seconds. • The Alarm Suspend icon shows a bell with an “X” and the words 2 Min when the SILENCE hard key has been momentarily pressed. ALARM INHIBIT

The alarm inhibit icon appears in the parameter boxes when one or more of an individual parameter’s alarms are turned OFF. ECG WAVEFORM

The lead number and scale setting are displayed in the top left corner of each slot set for ECG waveforms. The amplitude bar, shown in white, indicates the scale in millivolts (mV). SPO2 WAVEFORM

The waveform is auto ranging where the monitor attempts to keep the waveform centered in the slot at all times. No amplitude bar is shown. CO2 WAVEFORM

The CO2 waveform, capnogram, is always displayed in percent regardless of the units selected for displaying the numerical data. The maximum range of the capnometer waveform is 12.5%. BREATH BY BREATH BAR GRAPH (B×B)

The breath by breath bar graph is a method of representing the concentration of CO2 at the end of each breath. The data is always displayed in percent with a maximum range of 12.5%. O2 WAVEFORM

The maximum range of the oxygen waveform is 100%. The units are always in percent.

2 —7

MEDRAD Veris 8600

PRIMARY AGENT WAVEFORM

The primary agent waveform is displayed in percentage only as is the display for primary agent numerical data. The waveform is autoranging within the slot. Secondary agents are not displayed as waveforms. NITROUS OXIDE (N2O)

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IBP WAVEFORMS

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The N2O waveform is derived from the agent detector of the Veris monitor.

Selectable IBP sites are as follows:

The labels identifying the source of the IBP waveforms appear between the upper and lower range values at the beginning of the waveform. The waveform has both manual and auto-ranging features. The selected range appears at the left side of the waveform. The scaling for IBP slots are locked at x1 and cannot be changed. Use the range settings to adjust the appearance of the waveform on the screen. See “Alarms and Messages” in Section 3 for details.

• • • • • • • •

Arterial (ART) Pulmonary Artery (PA) Central Venous (CVP) Right Atrial (RA) Left Atrial (LA) Intracranial (ICP) Left Ventricle (LV) Right Ventricle (RV)

There are two IBP channels. The color of each channel can be selected independently. If the amplitude of the waveform exceeds the selected range the waveform is clipped. An informational level alarm OFF SCALE appears in the Info Messages Box of the main screen display.

2 —8

2 —Monitor Setup

Numerical Parameter Boxes

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If a module is turned off in the PARAMS menu, the numerical parameters are replaced by the word OFF in each location. Smart parameters such as heart rate switch to another available module if possible. An alarm inhibit icon appears in the upper right corner or right center of a parameter box if an alarm limit is set to OFF. The alarm inhibit icon is red with a white “X” indicating that an alarm is turned OFF. ECG BOX

HR

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The numerical parameter box area is directly to the right of the waveform area. The area is broken into seven numerical boxes. There are three additional numerical boxes below the waveforms. The numerical parameter boxes display the measured value of the vital sign being monitored, the unit of measure, and parameterdependent information (such as the source for the heart rate or inspired/expired values for gases).

BPM

-+

60

ECG

The top parameter box, in the upper right hand corner, is dedicated to display the heart rate. The source of the heart rate (i.e. ECG, IBP, SpO2, or NIBP) is shown in the lower left corner of this box. The color of the numeric display for heart rate matches the color of the waveform source data. The right half of the ECG parameter box displays the gating output, the ECG module battery status, and an icon indicating that the monitor and remote display are communicating. The color of the gating icon matches the color of the waveform and numerical data of the source (i.e., ECG gating reflects the color of the ECG waveform and numerics).

SpO2

98 RESP

%

Br/m

20

SPO2 BOX

The SpO2 box displays the oxygen saturation in percent. RESPIRATION BOX

The Respiration box, to the right of the SpO2 box, displays the respiration rate. NOTE: Available on Anesthetic and Anesthetic with Temperature models only.

CO2 EXP INS

mmHg

200 ml/min

37

8

CO2 BOX

This box displays numerical values for expired and inspired CO2. The label EXP stands for expired (end-tidal) CO2 and INS stands for inspired CO2. The current Flow Rate is displayed in the upper right corner.

2 —9

MEDRAD Veris 8600

GAS BOX

Numeric data for oxygen and agent gases appear in the same box. The oxygen value is listed first followed by the primary halogenated agent and nitrous oxide concentrations. The top line lists expired values and the second line lists inspired values. Values are always INS Mixed ENF EXP10.5 INS10.0 shown in percent. An alarm inhibit icon displays to the right of each header to indicate alarm limits set to OFF. GAS % EXP

O2

17 21

HAL

N2O

0.4 39 2.3 64

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The label Mixed appears before secondary agent concentrations listed at the bottom of the gas parameter box. This indicates that more than one agent is detected in the system and measures the secondary agent detected. The abbreviated name of the secondary agent is located after the Mixed label. The label Wrong appears before secondary agent concentrations listed at the bottom of the gas parameter box. The system detects an agent other than one set in the configuration of the system. If using more than one agent, set the Agent to Monitor selection in the PARAMS menu to Auto. The abbreviated name of the secondary agent is located after the Wrong label. If the internal gas features are shut off in the PARAMS menu, the displayed values are replaced by the word OFF in each location. IBP BOXES

mmHg

IBP1 ART AR

145/105

(125) mmHg

IBP2 CVP

(

13)

The monitor displays the systolic, diastolic, and mean pressure pulsatile waveforms. The systolic and diastolic values are shown in large text. The mean value (MAP) is displayed below the systolic and diastolic values in smaller characters. All MAP values are shown in parenthesis. Non-pulsatile waveforms have only a mean value. Non-pulsatile waveforms mean values are shown in large text and are centered in the box.

2 —10

2 —Monitor Setup

NIBP BOX NIBP

AGE

21:13 min

149/106

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CYCLE

(127) MAP

OFF

The NIBP numerical box is located near the center of the screen below the waveforms. It displays the systolic, diastolic, and mean pressure after a NIBP reading has completed. The systolic and diastolic values are shown in large text. The mean value (MAP) is displayed to the right of the systolic and diastolic values in smaller characters. MAP values are shown in parenthesis. When there is no valid reading, dashes are displayed. A valid reading is dashed after 30 minutes. If a valid reading is displayed, the age of the reading is displayed. After 30 minutes the age of the measurement goes to dashes; if there is no valid reading, the age also appears as dashes.

NIBP

AGE

21:13 min

149/106

CYCLE

4:00:00

T1 This copy of 3010796 Rev 1 is valid as of Nov-04-2005 at 12:11:00. The signed original is maintained in Documentation Systems. Prior to use, you are responsible to confirm this copy's revision is the latest released.

mmHg

T2

mmHg

(127) ET

MAP 3:45:37

96.4 97.7

F F

Main Menu

If a cycle time is set, the interval is displayed. Otherwise the cycle time displays the word OFF in the NIBP box. If a cycle time is active, the amount of time remaining (ET) until the next NIBP reading is scheduled is displayed at the bottom right of the box. TEMPERATURE BOXES

The top temperature numerical box is dedicated to temperature channel 1. The lower box is dedicated to channel 2. The units (°F or °C) appear in the upper right corner of each box. The main menu area is directly under the Temperature and NIBP boxes on the left-hand side of the screen. There are up to eight selectable soft keys located on the screen as shown below. NOTE: The Veris 8600 screen layout depends on the configuration of the monitor.

ALARMS

PARAMS

DISPLAY

ZERO IP1

ADM/DIS

CONFIG

PRINT

ZERO IP2

Figure 2-5: Main Menu One of the eight softkeys is always highlighted. If the user pushes the menu knob the menu window associated with the highlighted softkey is displayed and the menu knob control goes to that new window. Different soft keys are selected by turning the menu knob clockwise or counterclockwise until the desired key is highlighted. ZERO IP1 and ZERO IP2 do not access settings windows. On units without IBP the ZERO IP1 and ZERO IP2 boxes are blank. More information about the soft keys and their function is explained in “Softkey Functions (Main Menu)” on page 2-14.

2 —11

MEDRAD Veris 8600

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Alarm and Message Areas

The two alarm lines are located under the NIBP numerical box. All alarm and error messages for NIBP, respiration, and temperature are displayed in this area. ECG, SpO2, CO2, O2, N2O, Agent, and IBP high and medium alarms are displayed here if there is not an active waveform associated with them. All low level messages are displayed in the top alarm line. The bottom line is for informational messages and advisory level alerts only. The informational, low, and medium level alarm warnings are colored yellow and the high alarm warning messages are red. For more information about alarms see “Alarm Description” on page 3-1.

System Status Box

The system status box is located directly below the two lines reserved for alarms and messages. BATTERY WARNING ICONS

+-

There is space reserved for two battery icons. The battery icons represent the state of the internal rechargeable batteries. See “Battery Indicators” on page 2-2 and “Charging the Battery” on page 2-1 for a complete description of the icons and battery charging. PATIENT SIZE MODE

The next item in the status line is the patient mode. This message lets the user know what the patient size or mode the system is in: ADULT, PEDIATRIC, or NEONATE. The default physiological alarm limits may change depending on which mode is currently in use. Patient Information and Clock

A Patient Information Bar runs along the bottom of the display. This area displays the last name (12 characters), the first name (10 characters) and middle initial (one character) of the patient, the hospital identification number for the patient (16 characters), and the patient’s room number (five characters). A clock appears to the extreme right of the patient information. This displays both current date and time.

2 —12

2 —Monitor Setup

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Keypad

There are nine keypad buttons, including the ON/OFF button and the eight dedicated function keys. Some of the keys have two functions. The primary function is activated with a momentary press of the key. A secondary function, if present, is activated when the key is pressed and held for two seconds. Key

Function

On/Off

Power button. Press to activate the patient monitor and press and hold to turn the monitor off.

Freeze

A single press of this key freezes all waveforms on the screen. Numeric data continues to be updated for monitored parameters. A second press of this key resumes continuous waveform display.

NIBP Cycle/Stat Press the key momentarily to display the NIBP cycle popup menu on the screen. Press and hold this key to begin a Stat measurement.

NIBP

NIBP measurement start key. Press the key again to cancel an NIBP measurement.

Print

Press once to begin printing or for serial output. Press a second time to stop printing.

Silence

Press this key momentarily to begin a 2 minute alarm silence. Press and hold the key to permanently silence the alarms. Press the key again, a second time, to resume normal alarms.

Default

Press this key momentarily to access custom default profiles. Press and hold the key to alter custom default profiles (password MEDRAD required).

Trend

Displays the trend table when pressed momentarily. Press the key to exit the trend window. While the trend table displays, press and hold to access the trend settings menu.

Stand By

Press this key momentarily to enter standby mode. Press the key again to exit the standby mode.

When any of the keys is pressed once, a single audible beep notifies the user that a primary function has been activated. When a key is pressed and held a double beep notifies the user that a secondary function is selected.

2 —13

MEDRAD Veris 8600

Softkey Functions (Main Menu)

ALARMS

PARAMS

DISPLAY

ZERO IP1

ADM/DIS

CONFIG

PRINT

ZERO IP2

Figure 2-6: Main Screen Menu

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Softkeys are selected by turning the menu knob clockwise or counterclockwise until the desired softkey is highlighted. In the sample below the ALARMS softkey is highlighted indicating that the alarm settings window displays if the menu knob is pressed.

If the menu knob is rotated, any window associated with the highlighted softkey is displayed when the menu knob is pressed. The menu knob then controls scrolling through that new menu window. NOTE: For monitors without invasive blood pressure the two softkeys at the right end of the main menu are disabled and blank. The invasive blood pressure zero buttons do not activate windows. The top item (EXIT) on each menu window automatically highlights when the window is activated. The user may simply press the menu knob a second time to exit each window without making changes. At the bottom of the first window there may be selections allowing access to subordinate windows. Some windows and settings discussed in this manual may not be present if the feature is not installed in the monitor. If an alarm has been turned OFF in the PARAMS window, settings in other windows, such as alarm limits, may be disabled. Changing Settings

Turn the menu knob to highlight items on these menu windows. Press the menu knob to select the item. A single short beep is generated. The key press beep is audible even when alarms are silenced. Some of the settings require a letter or number to be entered. Rotate the menu knob to select the desired character. Press the menu knob to select the character. If an error is made while entering in the ADM/DIS screen, a left arrow character can be selected in order to back over the existing text. The down arrow character can be selected to jump to the next line. The arrow characters are not available when entering passwords.

2 —14

2 —Monitor Setup

Saved Setting Profiles

Alarms and parameter default settings may be independently modified as part of a customized default profile. Setting changes generally remain after the monitor is power cycled.

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• Changes made to the settings remain in current memory until a patient is discharged or the monitor is left without power. • If the monitor loses its current setting it returns to the last profile selected from the memory. If no profile has ever been selected, the initial profile is CUSTOM DEFAULTS and begins with the same settings as the Factory Default Settings listed in “Factory Defaults” on page 2-39. • The permanent Factory Default profile can be accessed and restored in the CONFIG window. • The user defined profiles can be accessed and restored by pressing the DEFAULT key. Making and saving settings profiles is described later in this manual. Also see “Unit and Configuration Defaults” in Appendix B for instructions for loading CONFIGURATION defaults (Base System, Cardiac System or Anesthesia System, depending upon your unit’s configuration).

2 —15

MEDRAD Veris 8600

ALARMS Softkey

ALARMS

PARAMS

DISPLAY

ZERO IP1

ADM/DIS

CONFIG

PRINT

ZERO IP2

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Figure 2-7: ALARMS Softkey Selected This softkey allows access to all the parameter alarm settings. When the menu is activated by pressing the menu knob, an alarm limit settings window appears. The alarm window appears as the Adult, Pediatric, or Neonate window as set in the third item Patient size. EXIT Alarm Volume ECG Lead Fail Patient size Heart Rate SpO2 NIBP Systolic NIBP Diastolic NIBP Mean Temperature 1 Temperature 2 Respiration CO2 Ins CO2 Exp O2 Ins O2 Exp Apnea

°F °F mmHg mmHg % %

Other Alarms

5 MEDIUM Adult HIGH LOW 150 40 OFF 90 200 50 100 30 150 50 100.0 93.0 100.0 93.0 36 OFF 10 5 55 20 100 18 100 OFF 20 seconds No Action

Figure 2-8: Alarm Settings Window (Adult) The pediatric and adult settings initially are identical, as factory defaults, but can be adjusted independently and saved as desired. EXIT Alarm Volume ECG Lead Fail Patient size Heart Rate SpO2 NIBP Systolic NIBP Diastolic NIBP Mean Temperature 1 Temperature 2 Respiration CO2 Ins CO2 Exp O2 Ins O2 Exp Apnea

°F °F mmHg mmHg % %

Other Alarm Setups

5 MEDIUM Neonate HIGH 180 OFF 140 80 100 100.0 100.0 60 10 55 100 100 20 seconds

LOW 90 90 35 30 35 93.0 93.0 14 5 20 18 OFF

No Action

Figure 2-9: Alarm Settings Window (Neonate)

2 —16