Ivy Biomedical Systems 3000 Series User manual

Part No. 2718-55-16
OPERATION MANUAL
© 2010 IVY Biomedical Systems Inc. All Rights Reserved.
Part No. 2718-04-16
Cardiac Trigger Monitor
Model 3000 Series

User Responsibility
This product will perform in conformity with the description thereof contained in this Operation Manual and
accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the
instructions provided. This product must be checked periodically. A defective Product should not be used. Parts that
are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or
replacement become necessary, IVY Biomedical Systems, Inc. recommends that a telephone call or written request
for service advice be made to IVY Biomedical Systems, Inc. Service Department. This product or any of its parts
should not be repaired other than in accordance with instructions provided by IVY Biomedical Systems, Inc. trained
personnel. The product must not be altered without the prior written approval of IVY Biomedical Systems, Inc.
Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction, which
results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than IVY
Biomedical Systems, Inc.
CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner.
Ivy Biomedical Systems, Inc. has declared that this product conforms with the Eurpean Council Directive 93/42/EEC
Medical Device Directive when its used in accordance with the instructions provided in the Operation and
Maintenace Manual.
Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford, Connecticut 06405. USA
[phone] [phone] FAX [phone]
www.ivybiomedical.com e-mail:[e-mail]
OEM OM3000
21 January 2011
2718-04-16 Rev.07

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Declaration of Conformity
Manufacturer: Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford, CT 06405
Authorized Representative: Cavendish Scott Ltd.
Starlings Bridge, Nightingale Road
Hitchin, Herts, SG5 1FW, England
Type of Equipment: Physiological Monitors
Models: 3000 (Series)
We, Ivy Biomedical Systems, Inc., hereby declare that the devices mentioned above
comply with the Swedish National Board of Health and Welfare Regulation and
guidelines on medical devices LVFS 2003:11 (M) 28 October 1994 – transposing
European Medical Devices Directive 93/42/EEC.
Date of Validity: March 30, 2010
Classification: IIb According to rule No. 10
Conformity Assessment
Procedure: Annex II
Notified Body: Intertek SEMKO AB Notified Body No. 0413
Name of Authorized Signatory: Dick Listro
Position held in Company: Director of Regulatory
Signature

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Table of Contents
Model 3000 Operation Manual i
Table of Contents
WARRANTY...................................................................................................................................................... iii
INTRODUCTION ................................................................................................................................................1
SAFETY ................................................................................................................................................................2
Electrical................................................................................................................................................................2
Explosion ...............................................................................................................................................................2
Patient Connections..............................................................................................................................................3
MRI........................................................................................................................................................................3
Pacemakers............................................................................................................................................................3
Electrosurgery Protection....................................................................................................................................3
Defibrillation Protection ......................................................................................................................................3
EMC.......................................................................................................................................................................3
Electromagnetic Compatibility IEC 60601-1-2:2001...............................................................................3
Description of Warning Labels............................................................................................................................8
MONITOR DESCRIPTION................................................................................................................................9
Classification.........................................................................................................................................................9
Control and Indicators.......................................................................................................................................10
Basic Keys..............................................................................................................................................10
Programmable Keys ...............................................................................................................................10
Menu Structure (with Polarity Control and Simulator option) ...............................................................11
Menu Structure (without Polarity Control and Simulator option) ..........................................................12
Display ...................................................................................................................................................13
Alarms....................................................................................................................................................14
Rear Panel ..............................................................................................................................................14
Fuse Ratings ...........................................................................................................................................15
MONITOR SETUP ............................................................................................................................................16
Set up the instrument for operation..................................................................................................................16
Change Mains Voltage.......................................................................................................................................16
Set the Language.................................................................................................................................................16
Set Time, Date, and Audio .................................................................................................................................16
Trace Speed.........................................................................................................................................................17
Default Settings...................................................................................................................................................17
ALARM MESSAGES ........................................................................................................................................18
ECG MONITORING.........................................................................................................................................19
Safety Considerations.........................................................................................................................................19
Patient Connections............................................................................................................................................20
ECG Waveform Amplitude (Size).....................................................................................................................20
Lead Selection.....................................................................................................................................................21
AC Power Filter..................................................................................................................................................22
ECG Filter...........................................................................................................................................................22
Alarm Limits.......................................................................................................................................................23
Pacemaker...........................................................................................................................................................23

Table of Contents
ii Model 3000 Operation Manual
RECORDER OPERATION ..............................................................................................................................24
Changing Paper ..................................................................................................................................................24
Recorder Modes..................................................................................................................................................25
Recorder Speed...................................................................................................................................................26
Example Printout................................................................................................................................................26
SYNCHRONIZED OUTPUT (TRIGGER)......................................................................................................27
The Synch Pulse..................................................................................................................................................27
Trigger-Mark Display........................................................................................................................................27
Polarity Control Option.....................................................................................................................................28
MONITOR TESTING........................................................................................................................................29
ECG Simulator (Optional).................................................................................................................................29
MAINTENANCE AND CLEANING................................................................................................................30
Monitor................................................................................................................................................................30
Patient Cables .....................................................................................................................................................30
Preventive Maintenance.....................................................................................................................................30
ACCESSORIES..................................................................................................................................................31
ECG .....................................................................................................................................................................31
Disposal................................................................................................................................................................31
SPECIFICATIONS ............................................................................................................................................32

WARRANTY
Model 3000 Operation Manual iii
WARRANTY
All products manufactured by Ivy Biomedical Systems, Inc. under normal use, are warranted to be free from defects
in material and workmanship and to operate within published specifications, for a period of one year from date of
original shipment.
All accessories such as patient cables and lead wires, supplied by Ivy Biomedical Systems, Inc. under normal use,
are warranted to be free from defects in material and workmanship and to operate within published specifications, for
a period of 90 days from date of original shipment.
If an examination by Ivy Biomedical Systems, Inc. discloses such product(s) or component part(s) to have been
defective, then Ivy’s obligation is limited at Ivy’s option, to repair or replacement.
When a product or products need to be returned to the manufacturer for repair or examination, contact customer
service personnel at Ivy Biomedical Systems, to obtain a Return Material Authorization number (RMA #) and the
correct packing instructions:
Customer Service
Telephone: [phone] or [phone].
Fax: [phone].
E-mail: [e-mail]
All products being returned for warranty repair shall be shipped prepaid to:
Service Department
Ivy Biomedical Systems, Inc.
11 Business Park Drive.
Branford, CT. 06405. USA.
Ivy will prepay the shipment of the repaired or replacement product to customer at Ivy’s expense.

WARRANTY
iv Model 3000 Operation Manual
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