Ivy Biomedical Systems 3150-B User manual

Part No. 2718-55-16
OPERATION MANUAL
© 2014 IVY Biomedical Systems Inc. All Rights Reserved. Part No. 2718-24-16
Cardiac Trigger Monitor
Model 3150-B
Designed exclusively to operate with
GE Healthcare CT Scanners
GE Part Number: 5304770

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 Email: [email protected]
OM3150-B
3 March 2014
2718-24-16 Rev.02

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Table of Contents
Model 3150-B 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 ...........................................................................................................................7
MONITOR DESCRIPTION ...............................................................................................................................8
Classification.........................................................................................................................................................9
Control and Indicators.......................................................................................................................................10
Basic Keys..............................................................................................................................................10
Programmable Keys ...............................................................................................................................11
Menu Structure.......................................................................................................................................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
Low Signal Message ...........................................................................................................................................24
ECG Notch Filter................................................................................................................................................24
Alarm Limits.......................................................................................................................................................25
Pacemaker...........................................................................................................................................................25

Table of Contents
ii Model 3150-B Operation Manual
SYSTEM INTERLOCK OPERATION ...........................................................................................................26
System Interlock Messages ................................................................................................................................26
PATIENT IDENTIFICATION NUMBER.......................................................................................................27
Patient Identification and other controls using ETHERNET MODE ...........................................................27
ECG DATA STORAGE AND TRANSFER ....................................................................................................28
ECG and Impedance Data Transfer using the USB Port ..............................................................................28
USB Port..............................................................................................................................................................28
RECORDER OPERATION .............................................................................................................................29
Changing Paper ..................................................................................................................................................29
Recorder Modes..................................................................................................................................................30
Recorder Speed...................................................................................................................................................31
Example Printout................................................................................................................................................31
ALARM MESSAGES ........................................................................................................................................32
Low Signal message...............................................................................................................................32
Pacer Detect message .............................................................................................................................32
Check Electrode message.......................................................................................................................32
MONITOR TESTING .......................................................................................................................................33
ECG Simulator ...................................................................................................................................................33
TROUBLESHOOTING.....................................................................................................................................34
MAINTENANCE AND CLEANING ...............................................................................................................35
Monitor................................................................................................................................................................35
Patient Cables .....................................................................................................................................................35
Preventive Maintenance.....................................................................................................................................35
ACCESSORIES..................................................................................................................................................36
ECG .....................................................................................................................................................................36
Disposal................................................................................................................................................................36
SPECIFICATIONS ............................................................................................................................................37

WARRANTY
Model 3150-B 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: [e-mail]
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.

WARRANTY
iv Model 3150-B Operation Manual
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INTRODUCTION
Model 3150-B Operation Manual 1
INTRODUCTION
This manual is to provide information on the correct use of the Model 3150-B Cardiac Trigger monitor. It is up to
the user to ensure that any applicable regulations regarding the installation and operation of the monitor are
observed.
The Model 3150-B is a Medical Electrical Equipment intended to monitor patients under medical supervision. The
Model 3150-B monitor must be operated by trained and qualified medical personnel only.
Using This Manual
We recommend that you read this manual before operating the equipment. This manual is written to include all
options. If your monitor does not include all options, menu selections and display data for those options will not
appear on your monitor.
Use the Monitor Description section for general descriptions of controls and displays. For details on the use of each
option, refer to the section of the manual dealing with the appropriate option.
Boldface type is used in text to refer to the labeling on user controls. Special brackets [ ] surround menu
selections used with the programmable keys.
Manufacturer’s Responsibility
The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the
equipment only if:
Assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the
manufacturer
The electrical installation complies with all applicable regulations
The equipment is used in accordance with the instructions in this manual
Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures
relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury.
Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford, Connecticut 06405
[phone] or [phone]
fax [phone]
e-mail: [e-mail]
This manual explains how to set up and use the Model 3150-B. Important safety information is located throughout
the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE YOU
OPERATE THE MONITOR.

SAFETY
2 Model 3150-B Operation Manual
SAFETY
Electrical
This product is intended to be operated from a mains power source of nominally 100 to 230V~, 47 to 63 Hz and
Maximum AC Power consumption: 45VA.
WARNING: To prevent electrical hazards to all personnel, this monitor must be properly grounded. Connect the
monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a
properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install
one in accordance with the governing electric code.
WARNING: Do not under any circumstances remove grounding conductor from the power plug.
WARNING: The power cable supplied with this equipment provides for this protection. Do not attempt to defeat
this protection by modifying the cable or by using ungrounded adapters or extension cables. The power cord and
plug must be intact and undamaged. To disconnect the equipment from the mains power; unplug the power cord.
WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer.
WARNING: If there is any doubt about the integrity of the protective ground conductor arrangement, do not
operate the monitor until the AC power source protective conductor is fully functional.
WARNING: Do not place the monitor in any position that may cause it to fall on the patient. Do not lift the
monitor by the power supply cord or patient cable.
WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to qualified service
personnel.
WARNING: To avoid electrical shock, disconnect the monitor from its power source before changing fuses.
Replace fuses only with same type and rating T.5A, 250V (Metric 5x20mm).
WARNING: Do not clean monitor while it is on and/or plugged into a power source.
WARNING: If unit is accidentally wet, discontinue use until dry and then test unit for proper operation before
reuse on a patient.
WARNING: This unit uses a common isolation path for the ECG leads. Do not connect any non-isolated
accessories to the ECG input when connected to a patient, as this may compromise the safety of the unit. When
attached to other devices, insure that the total chassis leakage currents of all units do not exceed 300 μA.
Explosion
DANGER: Explosion hazard! Do not use this equipment in the presence of flammable anesthetics or other
flammable substance in combination with air, oxygen-enriched environment or nitrous oxide.

SAFETY
Model 3150-B Operation Manual 3
Patient Connections
Patient connections are electrically isolated. For all connections use isolated probes. Don’t let patient connections
contact other conductive parts, including ground. See instructions for patient connections in this manual.
Carefully route patient cables to reduce the possibility of patient entanglement or strangulation.
Leakage current is limited internally by this monitor to less than 10 μA. However, always consider cumulative
leakage current that can be caused by other equipment used on the patient at the same time as this monitor.
To ensure that the leakage current protection remains within the specifications, use only the patient cables specified
in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected
lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an
unreasonable risk of adverse health consequences or death.
Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. To
minimize this problem, ensure proper electrode placement and cable arrangement.
If an alarm condition occurs while the alarms are set to off, neither visual nor audio alarms will be present.
MRI
The Model 3150-B should not be used within the magnetic field during Magnetic Resonance Imaging.
Pacemakers
Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias.
Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance.
Electrosurgery Protection
This equipment is protected against electrosurgery potentials. To avoid the potential of electrosurgery burns at
monitoring sites, ensure proper connection of the electrosurgery return circuit as described by the manufacturer’s
instructions. If improperly connected, some electrosurgery units might allow energy to return through the ECG
electrodes.
Defibrillation Protection
This equipment is protected up to 360 J defibrillator discharge. The monitor is internally protected to limit current
through the electrodes to prevent injury to the patient and damage to the equipment as long as the defibrillator is
used in conformance with the manufacturer’s instructions.
EMC
This equipment has been certified to be protected to emissions and immunity according to IEC-60601-1-2.
Electromagnetic Compatibility IEC 60601-1-2:2001
CAUTION: Medical Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the Operation Manual.