Ivy Biomedical Systems 3000T User manual

Part No. 2718-55-16
OPERATION MANUAL
© 2010 IVY Biomedical Systems Inc. All Rights Reserved. Part No. 2718-52-16
Cardiac Trigger Monitor
With options T-A or T-B
Designed exclusively to operate with
Toshiba Medical Systems
CT Scanners
Toshiba Model 3000

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:[email protected]
OM 3000T
06 September 2012
2718-52-16 Rev.03

This page is intentionally left blank.

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 (T Option)
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

This page is intentionally left blank.

Table of Contents
Model 3000T 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 60601-1-2:2007 ..............................................................................3
Description of Warning Labels ...........................................................................................................................7
MONITOR DESCRIPTION ...............................................................................................................................8
Summary of main options....................................................................................................................................8
Intended Use .........................................................................................................................................................9
Classification.........................................................................................................................................................9
Control and Indicators.........................................................................................................................................9
Basic Keys................................................................................................................................................9
Programmable Keys...............................................................................................................................10
Menu Structure Model 3000T-A............................................................................................................11
Menu Structure Model 3000T-B............................................................................................................12
Display ...................................................................................................................................................13
Alarm Messages.....................................................................................................................................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
SYNCHRONIZED OUTPUT (TRIGGER) .....................................................................................................18
The Synch Pulse..................................................................................................................................................18
Trigger-Mark Display........................................................................................................................................18
Polarity Lock (P-Lock).......................................................................................................................................18
ECG MONITORING.........................................................................................................................................19
Safety Considerations.........................................................................................................................................19
Patient Connections............................................................................................................................................20
ECG Electrodes ..................................................................................................................................................21
Impedance Measurement ..................................................................................................................................21
ECG Waveform Amplitude (Size).....................................................................................................................22
Lead Selection.....................................................................................................................................................23

Table of Contents
ii Model 3000T Operation Manual
ECG MONITORING (cont’d)
Low Signal Message ...........................................................................................................................................24
ECG Notch Filter................................................................................................................................................24
Alarm Limits.......................................................................................................................................................25
Pacemaker...........................................................................................................................................................25
ECG DATA STORAGE AND TRANSFER (Model 3000T-B only)..............................................................26
ECG and Impedance Data Transfer using the USB Port ..............................................................................26
USB Port..............................................................................................................................................................26
RECORDER OPERATION .............................................................................................................................27
Changing Paper..................................................................................................................................................27
Recorder Modes..................................................................................................................................................28
Recorder Speed...................................................................................................................................................29
Example Printout................................................................................................................................................29
ALARM MESSAGES........................................................................................................................................30
Low Signal message...............................................................................................................................30
Pacer Detect message.............................................................................................................................30
Check Electrode message.......................................................................................................................30
MONITOR TESTING .......................................................................................................................................31
ECG Simulator ...................................................................................................................................................31
TROUBLESHOOTING.....................................................................................................................................32
MAINTENANCE AND CLEANING ...............................................................................................................33
Monitor................................................................................................................................................................33
Patient Cables.....................................................................................................................................................33
Preventive Maintenance.....................................................................................................................................33
ACCESSORIES..................................................................................................................................................34
ECG .....................................................................................................................................................................34
Disposal................................................................................................................................................................34
SPECIFICATIONS............................................................................................................................................35

WARRANTY
Model 3000T 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 13 months 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: [email protected]
All products being returned for warranty repair shall be shipped prepaid to:
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, any additional
costs such as brokerage or customs fees, import duty or other import taxes are the responsibility of the customer or
their representative.

WARRANTY
iv Model 3000T Operation Manual
This page is intentionally left blank.