Medrad Veris 8600 Operation Manual

PRELIMINARY

VerisTM 8600
Vital Signs Monitor

Operation Manual

3010796 Revision 0
Date 10/04

Page i

VerisTM 8600
Operation Manual

Copyright 2004, MEDRAD Inc. All rights reserved.
Reproduction of this manual is str ictly prohibited

without express written consent of MEDRAD, Inc.
For more information about MEDRAD products

and services, please visit www.medrad.com

Page ii

Contents

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

In Case of Emergency Contact.............................................................................xi

MEDRAD Subsidiaries.................. ...................................................................xi

International Offices.........................................................................................xi

Symbols.............................................................................................................. xiii

Regulatory Symbols.......................................................................................xiii

Safety Symbols...................................... ......................... ......................... ...... xiii

System Symbols............................................................................................xiv

Port Symbols.................................................................................................xiv

Miscellaneous Symbo l s................................. ......................... .......................xiv

Safety ...................................................................................................................xv

Definitions.......................................................................................................xv

Warnings.........................................................................................................xv

Cautions........................................................................................................xvii

Introduction .........................................................................................................xxi

Description.....................................................................................................xxi

Intended Use .................................................................................................xxi

Clinical Use...................................................................................................xx i i

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..................................................................................................1-6

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 Indicator s....................... ......................... ......................... ......................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

Softkey Functions (Main Menu).................................................................................. 2-14

Changing Settings............................................................................................2-14

Saved Setting Profile s............................................... .......................... ............. 2-15

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MEDRAD

ALARMS Softkey............................ .......................... ......................... ......................... .2-16

PARAMS Softkey (Physiological Parameters)........... ......................... ........................2-21

DISPLAY Softkey ........................................................................................................2-27

ADM/DIS Softkey (Admit/Discharge)...........................................................................2-31

CONFIG Softkey (System Configuration)....................................................................2-34

PRINT Softkey.............................................................................................................2-37

Default Settings.................................................................... ......................... ..............2-38

Veris

8600

Primary ALARMS Window................................................................................2-17

Invasive Blood Pressure Alarm Settings ..........................................................2-18

Agent Gas Alarms ............................................................................................2-19

Primary PARAMS Window ...............................................................................2-21

, Respiration, Temperat u re Menu............. ......................... ......................2-24

SpO

2

Gas Settings.................... ......................... .......................... ......................... .....2-25

Waveform Description......................................................................................2-27

Double Height Slots........................................................................ .. .. .. ..... .. .. .. .2-28

Cascaded Slots............................................... .................................................2-29

Gain and Sweep...............................................................................................2-30

Admitting and Discharging Patients..................................................................2-31

Adult/Pediatric/Neonatal (Patient Size) ............................................................2-32

Patient Information ...........................................................................................2-32

Procedure for Admitting a Patient.....................................................................2-32

Procedure for Discharging a Patient.................................................................2-33

Password Protection.........................................................................................2-35

Date Format......................................................................................................2-35

Time/Date Setting................................. ................................................... .........2-35

Freeze Timeout................................................. ......................... ......................2-35

Standby Timeout ..............................................................................................2-35

Standby Tone...................................................................................................2-35

Alarm Tone Warning.........................................................................................2-35

Print Device............... .................................................. .....................................2-35

Language Settings............................................. .. .... .. .. .. .. ..... .. .. .... .. .. .. .. ..... .. .. .. .2-36

Factory Defaults............................................ .................................................. .2-38

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

Low Limit Auto-Reset................................................................................3-5

SpO

2

SpO

Low Limit Off Alarm..................................................................................3-5

Triggering an Alarm.......................................................................................................3-6

Alarms Testing..................... ......................... .................................................. ..............3-6

2

Page iv

Contents

Alarm Message List ...................................................................................................... 3-7

Shared Source Alarms.......................................... ......................... ....................3-7

ECG Alarms.......................................................................................................3-7

Alarms......................................................................................................3-7

SpO

2

Temperature Alarms .......................................................................................... 3-8

NIBP Alarms....................................................................................................... 3-9

IBP Alarms....................................................................................................... 3-10

Capnometry (CO

Agent Gas Alarms and Messages....................................................................3-11

Oxygen Monitoring (O

System Alerts.............................................................................................................. 3-14

) Alarms and Messages....................................................... 3-11

2

) Alarms.......................................................................3-13

2

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....................................................................................................5-3

ECG Monitoring (Electrocardiogram)............. ............................................................... 5-4

Protection...........................................................................................................5-6

ECG Performance..............................................................................................5-6

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 Monitori n g................... ..................................................... 5-15

ECG Auto Lead Switching .......................................................................................... 5-16

Primary Lead . . .................................................................................................. 5-16

Alternate Lead Priority......................................................................................5-17

Gating Interface ..........................................................................................................5-18

Page v

MEDRAD

Veris

8600

Section 6 - NIBP

Theory of Operation ................................................................... ....... .... .... .. .... ....... .... ...6-1

Heart Rate..........................................................................................................6-1

Comfort Cuff™ Technology................................................................................6-1

Description of NIBP Meas u rement.................... .................................................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 Measurement s............................................ ......................... ....................6-8

Section 7 - SpO

Theory of Operation ................................................................... ....... .... .... .. .... ....... .... ...7-1

Heart Rate..........................................................................................................7-1

Definition.............................................................................................................7-1

DOX™ Digital Oximetry.............. .................................................... ....................7-1

Method................................................................................................................7-1

SpO

Clinical Testing and Accuracy...................................................................7-2

2

Gating Signals.................................................................................. .. .. ..... .. .. .. .. .7-2

Monitoring Procedures (Pulse Oximetry).............................................................7-3

SpO

2

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

Peripheral Gating ..............................................................................................7-10

SpO

2

2

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 (Quic k).....................................................................................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

Page vi

Section 10 - Anesthetic Agents

Contents

Theory of Operations..................................................................................................10-1

Integrated CO

and Agent Gas Detector ......................................................... 10-1

2

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 CO
Measuring Oxygen (O

Monitoring Procedure..........................................................................................11-4

CO

2

Monitoring Procedures ..........................................................................................11-5

O

2

Interfering Gasses for O

O Monitoring.............. .................................................. ......................... ..................11-5

N

2

)...................................................................................11-2

2

.................................................................................11-5

2

)................................................................11-1

2

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......................................................................................................12-2

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

Page vii

MEDRAD

Veris

8600

Appendix A: Maintenance

Cleaning and Disinfecting........................................................................ .. .... .. ....... .... ..A-1

Pulse Oximeter Sensors....................................................................................A-2

Blood Pressure Cuffs......................................................................................... A-2

Temperature...................................................................................................... A-3

Accidental Wettin g. ................................................... .................................................. ..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

............................................................................................................................ C-2

SpO

2

Heart Rate....................................................................................................................C-2

Gating...........................................................................................................................C-3

Temperature................................................................................................................. C-3

NIBP.............................................................................................................................C-3

Invasive Blood Pressure............................................................................................... C-4

Transducer........................................................................................................C-4

Capnometry (CO
CO

Respiration...........................................................................................................C-4

2

Halogenated Agents.....................................................................................................C-5

Nitrous Oxide (N
Oxygen Monitoring (O

Pneumatics...................................................................................................................C-6

Alarms..........................................................................................................................C-6

Trend Reports .......................... .. .. .. .. ..... .. .. .. .. .. .. .. .. ..... .. .... .. .. .. .. .. ..... .. .. .. .. .. .. .. .. ..... .... .. ..C-7

Printer (Remote Displa y onl y) ..................... .................................................................C-7

Controls........................................................................................................................C-7

System Outputs (Remote Disp la y Only)........................... ............................................C-7

Environmental..............................................................................................................C-7

Mechanical/Electrical....................................................................................................C-8

Remote Display................. ................................................................................ C-8

Main Monitor.............. .................................................. ......................................C-8

) .......................................................................................................C-4

2

O).....................................................................................................C-6

2

) ...............................................................................................C-6

2

Page viii

Contents

Appendix D: Accessories

ECG Accessories..........................................................................................................D-1

ECG Module.......................................................................................................D-1

ECG Electrode Accessories...............................................................................D -1

ECG Gating Accessories ...................................................................................D-1

SpO

Accessories.........................................................................................................D-1

2

Probes ......................................................................................................D-1

SpO

2

Peripheral Gating Accessories.................................................................D-1

SpO

NIBP Accessories.........................................................................................................D-2

IBP Accessories............................................................................................................D-2

Temperature Accessories.............................................................................................D-2

Agent Accessories ........................................................................................................D-2

Miscellaneous Accessories................................................................................ ...........D-3

Publications...................................................................................................................D-3

2

Reusable Cuffs...................................................................................................D-2

Disposable Cuffs................................................................................................D-2

Operation Manuals.............................................................................................D-3

Help Cards.........................................................................................................D-3

Installation and Service......................................................................................D-3

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: Wireless Communication

Wireless Network Communication Interface................................................................ G-1

Operation..................................................................................................................... G-1

Appendix H: Battery and Fuse Specifications

Battery Specifications ................................................................... ......................... .......H-1

Main Monitor Batt eries .......................................................................................H-1

Fuse Specification s................................................ ......................... ......................... .....H-2

Remote Display Fuses.......................................................................................H-2

Main Monitor Fuses............................................................................................H-2

Power Supply Fuses ..........................................................................................H-2

Fuse Removal/Replace men t.................................................. .......................... .............H-3

Remote Display..................................................................................................H-3

Power Supply.....................................................................................................H-4

Page ix

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In Case of Emergency
Contact

MEDRAD, Inc. Corporate Office MEDRAD, Inc. Service Repair

One Medrad Drive One Medrad Drive
Indianola, PA 15051-0780 USA Indianola, PA 15051-0780 USA
Telepho ne: 1 ( 412 ) 767-2 400 Telepho ne: 1 ( 412 ) 7 67-24 00
FAX: [phone] FAX: [phone]
OTHER: 1 [phone] OTHER: 1 [phone]

MEDRAD Subsidiaries

International Offices

Imaxeon Pty. Ltd.

Rydalmere Metro Centre (Alternate address:)
Unit 2, 38-46 Sout h Str ee t P.O. Box 150
Rydalmere NSW 2116 Rydalmere BC
Australia NSW 1701
Telepho ne: [phone] Sydney, Australia
FAX: [phone]

MEDRAD Europe B.V. Nihon MEDRAD K.K.

P.O. Box 205 9F Central Shin-Osaka Bl dg.
6190 AE Beek 4-5-36, Miyahara
The Netherland s Yodogawa-ku
Telepho ne: +3 1 ( 0) 43- 35 85 600 Osaka 532-0003, Japan
FAX: [phone] Telepho ne: +8 1 (0 ) 6-6 35 0- 068 0
(Visiting MEBV address:) FAX: [phone]
Horsterweg 24
6199 AC Maastricht Air p ort
The Netherland s

MEDRAD do Brasil ltda. Mediwest Denmark ApS
Av. Fagundes Filho, 191 - Naverland 2
conjuntos 51 a 54 e 57 2600 Glostrup
Ed. Houston Office Cen te r Denmark
Vila Monte Alegre Telepho ne: [phone]
04304-000 - São Paulo - SP FAX: [phone]
Telepho ne: +( 11 ) 5 079 -650 0
FAX: +(11) 5584-89 51

MEDRAD Middle East & Africa

92 Al Lasilky Street
New Maadi Ca i r o
Egypt
E-mail: Medrad_ME&[e-mail]
(If contacti ng Andre directly, please
phone or fax)
+00.20.2.754.88.29

Page xi

MEDRAD

MEDRAD France S.a.r.l. MEDRAD, Inc. (Asia)

8, rue des Pyrén ée s — Sil ic 51 4 200 Jalan Sultan #09- 01
Wissous Textile Centr e
F-94623 Rungis Singapore 199018
France Teleph on e: +( 65) 6 29 2 53 57
Telephon e: +33 (0 ) 1 .4 6.86. 98 .8 4 FAX: +(65) 6 292 7276
FAX: [phone]

MEDRAD Italia S.r.l. MEDRAD Medizinische Systeme

Via Togl iat ti , 11 1 Indust riestraße 2b
27051 Cava Manara (PV) 97332 Volkach
Italy Germany
Telephon e: +39 (0 ) 3 82 5528 82 Telephone: [phone]
FAX: [phone] FAX: +4 9 (0 ) 9381 /8 0 36 85

MEDRAD Mexicana S. de Mediwest Norway AS
R.L. de C.V.

Leibnitz, 204 Aslakveien 14 A
Col. Anzures Del. Migu el H id algo NO-075
CP. 11 59 0 Mexico City 3
Mexico D. F. 160 18 Oslo, Norway
Telephon e: +52 (5 55 ) 250- 65 75 Teleph on e: [phone]
FAX: [phone] FAX: [phone]

Veris

8600

GmbH

Mediwest Scandinavia AB MEDRAD UK Ltd.

Lona Knapes gata 5, pla n 2 25 Lancaster Way Business Park
S-421 32 Västra Frölunda Witchford, Ely
Sweden Cambridgeshire
Telephon e: +46 (0 ) 3 1-74 8 2 88 0 CB6 3NW
FAX: [phone] Teleph on e: +44 (0 ) 13 53 -6 450 24

FAX: [phone]

Page xii

Symbols

Symbol Definition

Regulatory Symbols

Safety Symbols

IPX0

IPX1

IPX2

European Community Mark

ETL Mark
FCC (US Federal Commu nicat io ns Commi ssi on)

Mark

ATTENTI ON ! Re fer to O p erati on Manu al for
Information

Shock Hazard

Type CF Equipment, defib proof
Indicates no pr o te ctio n ag ai ns t i ngres s of wate r

(remote display)
Identifies th e d egree of prot ec ti on agai nst fl uid a s

drip-pro of (main monitor)
Identifies th e d egree of prot ec ti on agai nst fl uid a s

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 batte r ies following ho spit al prot oc ols an d
local environme nt al re gu la tion s.

Do not incinera te! Keep away from fire or other
sources of extreme heat.

Page xiii

MEDRAD

Symbol Definition

Veris

8600

Dispose of batt er i es prop er l y in acc orda nc e wit h
hospital and local regulations.

Risk of electrical shock! Do not remove cover.
Refer servicing to qualified personnel.

System Symbols

Port Symbols

IOIOI

Fuse

Alternating Current (AC)

Direct Current (DC)

Wireless Device

Signal Inpu t

Signal Outpu t

Digital Output

Air Intake

Scavenging Port

Communication Port

Video Out

Page xiv

Symbols

Miscellaneous Symbols

Symbol Definition

Technical Supp ort Phone Nu mbe r

Manufacturing Contac t

SN

REF

2

Serial Number

Part Reference Number

Place this side against the skin (Blood Pressure Cuff)

Placement of the cuff over the brachial artery.

Single use device o nly. Do not reuse.

Page xv

Safety

Definitions

Warnings

Definitions for Warning, Caution, and Note symbols:

WARNING

!

CAUTION

!

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.

• Read this manual entirely before using the monitor.

• Inspect For Damage! User should inspect th e sy ste m 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 Ox ide.

!

!

Designates a p oss ible da nger ou s situ at i on.
Non-observance may lead to death or the most
severe injuries.

Designates a p oss ible da nger ou s situ at i on.
Non-obser vanc e may lead to min or in ju r ie s or
damage to the pr odu ct.

WARNING

!

!

• Possible ex plosion hazard! Do not use the monitor in the
presence of gas mixtures which m ay be flammable.

• Cables, tubing, and lead wires may present a risk of
entanglement or strangulation! Ve ri fy 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 patien t.

• Risk of electrical shock! Do not remove cover . Ref er servicing to
qualified personnel.

• 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: Nati onal 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 cont ainin g ferrous material in to the m agnet
room. Risk of serious inju ry and/or damage to equipment ca n
occur.

Page xvi

Safety

WARNING

!

• Do not route gating cables near or within the s canning volume.

• Apply brakes to preven t 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 sync hronizati on ou tput 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 incr ease d lea kage cur rents
may present a hazard to the patient.

!

• PACEMAKER PATIENTS: This device does not inclu de

pacemaker spike rejection capability. Heart rate readouts
derived from the ECG patient connections ar e li kely 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 SpO

function as the primary heart rate sourc e.

• 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 defective HF surgical
equipment neutral electrode connectio n.

• The heart rate calcul ated by the monitor may be affected by

cardiac arrhythmia.

• 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 caus ing a
safety hazard.

• Do not use with an open MRI. Use of the moni tor in an open

MRI may result in erratic or unavailable monitoring.

• Do not stand or sit on monitor ac ces sor ie s tray. Possible injur y

can result from falling.

2

Page xvii

MEDRAD

• Do not lift the monitoring system by the tray. Possible injury can

• U.S. Federal l aw restri cts this device to sal e by or on the or der

Veris

8600

WARNING

!

result from heavy weight.

of a physician.

!

Cautions

CAUTION

!

• Use only accessories des igna ted for use with this m onitor. Use
of accessories not designated for use with the Veris monitor can
cause inaccurate measurements and/or a sa fety hazard for the
patient.

• Equipment accuracy may be affected at extreme temperatures.

• Do not store equipment at extreme temperature. Temperatures
exceeding specified storage temperatures could damage the
system.

• Avoid routing the DC cable through the magnet room do or.
Possible damage can occur to the DC cable and/or the scanner
room door.

• Do not press on the keys with sharp or hard objects. This c ould
damage the keys. Use only your fingertips to press on the keys.

• Changes or modifications not expressly approved by MEDRAD,
Inc., may void the user's authority to operate the equipment and
may also void the warranty.

• Do not use the monitor in the path of a Li near Ac cel erator or
Positron Emission Tomography (PET) scanner beam. This could
result in inaccurate physiologic parameters or waveforms.

!

• Transporting the m onitor in a mob ile sc anner trailer can l ead to
damage from shock, vibration, or extreme temperatures.

• Do not allow the conductive parts of the pati ent el ectr odes to
contact other conductive parts, includin g ground (ea rth).

• Do not tip the monitor. Possible injury can res ult from falling.

• Do not stand on power supply enclosure. Injury fr om tr ipp ing o r
falling can occur.

• Do not stand on the base. 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.

Page xviii

CAUTION

!

• Do not bend fiber optic cables too tightly. Follow cable
manufacturers specifications for bend allowance.

• If a probe falls on the floor or into liquid, clea n 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.

!

Safety

Leakage Current

Voltage Fluctuations

Equipotential Ground

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 haz ard c aused by the
summation of leakage currents is poss ible, when several pieces of
equipment are interconnected.

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 li ne
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 batter y condition.

Health care providers and patients are subj ect to dange rous,
uncontrollable compensating currents for electrical equi pment.
These currents are due to the potential differences between
connected equipment and touchable conducting parts as found in
medical rooms.

The safety solution to the problem is accomplished wi th c onsistent
equipotential bonding. Medical equi pment i s fitted with con necti ng
leads made up with angled sockets to the equipotential bondi ng
network in medical rooms.

Equipotential

Connection Lead
(Socket)

Terminal

Equipotential
Connector

Earth Ground

Page xix

Main
Body

MEDRAD

Veris

8600

Software Error Related

Hazard Mediation

Potential Interference

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.

This device has been tested to 60601-1-2 specifie d 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 2nd Edition may experience operational issues when
used in proximity to this device.

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 lin e. This m onitor is designed
specifically for MR compatibility and is 1.5 and 3T c ompa tible. 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. T his effect is due to hem odyn amic flow
induced voltage and may interfere with QRS detection. Tr y other
leads and/or electrode placements for best results.

Use of Anesthetics

Biocompatibility

CONDUCTED TRANSIENTS

The monitor conforms with IEC 1000-4-4, and IEC 100 0-4-5 for
conducted transients, and will operate with negligible adverse effects.

X-RAY, CT, ULTRASOUND, AND/OR NUCLEAR MEDICINE

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

OTHER INTERFERENCE

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

Do not use this device in conjunction with flammable anesthetics
such as cyclopropane and ether. The monitor can sample from pur e
oxygen environments, but the monitor itself should never be placed
inside an oxygen rich environment, such as a n oxygen tent or gas
containment apparatus. Proper anesthetic gas waste recovery should
be used.

All patient-contact or user-contact m ater ials in this moni tor and i t's
accessories have passed ISO 10993-5, -10, & -11 bioc ompati bil ity
tests or have been in use in clinical environments in l arge num bers
over an extended period of time predating these standards.

Page xx

Safety

Probes Fall in Fluids

FCC and Industry Canada

Compliance

Audible Pulse Tone

Whenever probes fall and land in fluids, clean the probes according to
the cleaning instructions in “Cl eanin g and Disi nfecting” on page A-1.

This device complies with Part 15 of the F CC 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 no t expressly approved by the par ty
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 Industr y Canad a tec hnical s pec ific ations were m et.

IC: 5338A-CSI8600

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

!

Disposal Accessory Disposal

Latex Content

Discard disposable medical waste according to your instituti on's
policies and procedures to prevent biological contaminati on. Se e
“Disposal” on page A-7.

This MEDRAD product (patient monitor s and ap proved accessori es)
are free from latex in any location that may result in patient co ntact.

Page xxi

Introduction

Description

Intended Use

The VerisTM 8600 patient monitor is design ed 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, SpO
temperature, O
and alerts may be set for each parameter. Monitored parameter data
is stored as tabular trend information and may be pri nted or
downloaded.

The system is intended to moni tor physiological paramete rs of
patients within any health care environment, sp ecifi cal ly 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, sy stem alarms, and patient
analysis will be available to the care provider from the monitor.

The monitor shall be 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 sed ation, as r equi red by the JCAHO.

• And, provide image gating, to gate image ac quis ition to a
physiological parameter, such as the cardiac cycle.

, anesthetic gases, and IBP. User defined alarm limits

2

, CO2, respiration,

2

There is the additional requirement for the accurate functi on of th e
equipment in the MR environment. The monitor us ed 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) shall be capable of monitor ing a
full range of patients from neonate to adul t.

Page xxii

Introduction

Clinical Use

Before you Begin

This manual provides separate sections for measured parameters.
These sections provide instr ucti ons for patient connections and
monitoring. The caregiver is expected to be fully familiar with patient
monitoring techniques and with the functi ons of this mo nitor before
using it with a patient.

This system is designed to onl y m onitor one patien t at a time p er
monitoring system.

Protect yourself and your patient. Read the precautions for each
measured parameter that appears in each meas ure d parameter
section.

These instructions d esc r i be the use of the basi c sampl ing 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 b efore use.

Check that the AC (Mains) power cord is plugged in for long­term monitoring situ ations.

2. Check the menus and default settings to confirm that the

monitor is setup correctly.

3. Examine the accessor ies for wear, damage or contamination.

Replace or disinfect the accessories as req uir ed.

4. Turn the de sired monitoring modules to ON in the PARAMS

softkey window.

5. Select the correct mode of operation (Adul t /Pediatric/Neonate)

by entering the patient size in the ADM/DIS softkey window.

CAUTION

!

• All accessories connected to the pa tient m onitor must compl y

with all applicable UL (Underwriters Laborator ie s) sta ndards
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.

!

Page xxiii

1 — Panel Features

Front Panel

This section provides an overview of the
panels, switches, accessory connections, and communicati on
sockets.

The front panels of the monitor an d the o ptiona l r emote d isp lay
feature a color flat-screen display. Located bel ow the screen i s the
primary c ontrol pa nel 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

Veris

8600 monitor’s control

Water Trap

Receptacle

(Anesthesia

Monitors only)

Figure 1-1:

Power

Switch

Veris

8600 Front Controls

1 —1

Keypad

Menu
Knob

MEDRAD

Veris

8600

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

Sampling

Line

Connection

AC Power

Indicator

Menu Knob

Color Display

Water Trap and

Gas Sampling Connec tion

Water Trap

Keys

Menu Knob

Figure 1-2: Detail of Lower Front Panel

The menu knob can be turned le ft or r ight 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 whic h
may be selected and activated by the menu knob are also displayed
on this and the optional remote dis play screen.

The water trap connection is a feature on Anesthesia and Anesthesia

Function

with Temperature models only. MEDRAD
analysis capability have a blank plate in this loc ation. The water trap
is easily accessed on the fron t of the monito r. The gas samp ling line
is connected to the water trap and it is used for CO
agent monitoring. The sample li ne fi tting is a stan dard female Luer­lock connector when using the WaterChek

Veris

monitors without gas

, O2, N2O, and

2

™

2+ water trap accessory.

1 —2

1 —Panel Features

Left Side Panel (Mai n Monitor)

The left side of the main monitor has u p to ni ne c onnections for
patient monitoring. The electrocardiogram (ECG), pulse oximetry
(SpO

), and the non-invasive blood pressure (NIBP) connections are

2

standard on all
All potential

Veris

8600 models.

Veris

main monitor connections are desc ribed in the

picture below.
The optional remote display has no patient c onnections.
More information about accessory connections can be found in the

patient monitoring sections of this ma nual.

ECG Input/
Output

Temperature

Gating
Signal

SpO

2

IBP

Figure 1-3:

Veris

8600 Left Side

NIBP

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 com munication
between the main monitor and the remote dis play. See the
Installation Instructions for installing the fibe r o ptic com municatio ns.

See “Figure 1-8:: Remote Display Fiber Optic Connection s” on
page 1-7 for the location of the fiber optic ports on the remote display.

NOTE: These connections have pro tec tive co ve rs that nee d to be
removed before use.

Fiber Opti c

Input and

Output

Connectors

Figure 1-4: Main Monitor Fiber Optic Connections

1 —4

Main Monitor Base
Connections

1 —Panel Features

DC Connection

Exhaust Port

Air Intake

Port

Chassis Ground

DC Connection

Exhaust Port

Air Intake Port

DC Connection & Exhaust Port

Figure 1-5: Main Monitor Base Connections

The

Veris

monitor has an interna l c hassis 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.

The exhaust port is located o n the base of the Anes thesi a mon itor
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 sample s.

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

!

1 —5

MEDRAD

r

e

Veris

8600

Remote Display

The remote display displays the patient data in another location .
Changes to the display can be made from the re mote displ ay and be
effected on the patient monitor.

Printer Release

Lever

Printer Feed
Advance

Printe
Door

Servic
Access
Panel

Fuse
Access
Panel

Communication

Connections

Figure 1-6: Remote Display Rear View

Chassis

Ground

AC Power
Connection

1 —6