Mac-Lab/CardioLab/Centricity
Cardiology INW
Service Manual
2063076-010H EN
2012 - 2014 General Electric
Company. All rights reserved.
Publication Information
The information in this manual only applies to Mac-Lab/CardioLab/Centricity Cardiology INW software version
6.9.5. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this
manual are subject to change without notice.
†
Mac-Lab, CardioLab, Centricity, CardioICE, DASH, Innova, Solar, TRAM, TRAMNet, TRAM-RAC and Vivid are
all trademarks of GE Healthcare companies.
††
All third party trademarks are the property of their respective owner.
Micropace digital stimulators are sold by GE Healthcare for Micropace EP Inc.
GE Healthcare, a division of General Electric Company
GE and the GE Monogram are trademarks of General Electric Company.
The document number and revision appear on the bottom of each page. The following table outlines the changes
applied with each revision.
RevisionDateComment
A15 August 2012Internal release.
B22 August 2012Initial public release.
C21 January 2013Updated with serviceability improvements.
D2 April 2013Updated to distinguish between US and non-US system compliance.
E7 May 2013Updated to include installation and troubleshooting procedures for the Matrox Quad video
board.
F18 November 2013Updated to include information for new speakers.
G20 June 2014Updated to include information for EIZO monitors and new desk part numbers. Updated part
H30 July 2014Updated to include new IEB power cord compliance information and part numbers.
numbers for RoHS compliance.
T-2Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual2063076-010H EN
xiiMac-Lab/CardioLab/Centricity Cardiology INW Service Manual2063076-010H EN
Chapter 1
Introduction
2063076-010H EN Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual1-1
Introduction
Manual Information
Purpose
This manual contains the instructions necessary to operate and service the Mac-Lab/CardioLab
and/or Centricity Cardiology INW system safely in accordance with its function and intended use.
These instructions include but are not limited to:
Describing fundamental controls and indicators
Operating procedures
Connecting and disconnecting detachable parts and accessories
Troubleshooting and service procedures
Product References
The name of the product described in this manual is Mac-Lab/CardioLab. It will also be referred to
as “the system” throughout this manual.
Intended Audience
This manual is written for trained GE Healthcare Field Service Engineers and hospital Biomedical
Technicians who use, maintain, troubleshoot, and service the Mac-Lab/CardioLab system. Service
professionals are expected to have a working knowledge of appropriate medical, electrical, and
mechanical procedures, practices and terminology used in the service of the equipment.
Operators
Operators can record and calculate cardiovascular data from pediatric or adult patients as they
undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via
interfaced GE Healthcare TRAM/PDM modules or other interfaced systems.
The Mac-Lab/CardioLab operator requires training to become familiar with the capabilities and
operations of the Mac-Lab/CardioLab system. The following training options are available:
Classroom training at GE Healthcare Institute in Milwaukee, WI
On-site customer training
Video training via weblink
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System Administrator
Coordinating the overall Mac-Lab/CardioLab system is the responsibility of the System
Administrator. This person has access to additional system supervisory functions, including
operational setup parameters, system backup functions, for example.
The System Administrator is also responsible for monitoring and reporting system hardware
and software problems using the procedures described in the Mac-Lab or CardioLab operator
manual.
The Mac-Lab/CardioLab System Administrator should be familiar with the Windows desktop
and be fully trained on the Mac-Lab/CardioLab features and configuration settings.
NOTE: A System Administrative password is required to perform any of the previous
administrative functions.
The Mac-Lab/CardioLab System Administrator requires training to become familiar with the
capabilities and operations of the Mac-Lab/CardioLab system. The following training options
are available:
Classroom training at GE Healthcare Institute in Milwaukee, WI
On-site customer training
Introduction
Field Service Engineer
Diagnosing and correcting problems with the Mac-Lab/CardioLab system must be done by a
trained GE Healthcare Field Service Engineer. Please refer system problems not covered in this
manual to GE Healthcare Product Support.
Indications for Use
Types Of Systems
The following system names are used:
Mac-Lab is a Hemodynamic Recording System.
CardioLab is an Electrophysiology Recording System built on a common platform with
Mac-Lab.
ComboLab is a single system that contains the features of both the Mac-Lab and the
CardioLab systems.
SpecialsLab is a system with a subset of the features available on the Mac-Lab.
2063076-010H EN Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual1-3
Introduction
Mac-Lab System
The Mac-Lab System is intended for acquiring, filtering, digitizing, amplifying, measuring and
calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients.
Clinical data may include: ECG waveforms, heart rate, pulse oximetry (SpO
CO
(EtCO2), temperature, hemodynamic measures (for example, valve gradients and areas,
2
cardiac output, shunts, Fractional Flow Reserve (FFR), invasive and noninvasive blood pressure).
Physiology parameters such as diastolic, systolic, and mean pressures, and heart rate may be
derived from the signal data, displayed and recorded. The data may be entered manually or
acquired via interfaced devices and/or information systems and may be used for report generation.
Procedural information and optional anatomical and physiological imaging and data devices may
be interfaced (for example, X-ray, ultrasound, patient monitors and information systems). The
Mac-Lab System can display, store and annotate images previously acquired and stored by other
systems. Data may be provided to other systems via multiple formats (for example, HL7, DICOM,
Analog outputs). Data may be received from other devices via multiple formats (for example,
DICOM, Analog inputs).
Optional accessories for hardware and software may include research tools to be used exclusively
outside patient care settings. The purpose of the research tools is to assist researchers or
clinicians in developing algorithms.
), respiration rate,
2
The Mac-Lab System does not have alarms, does not generate energy delivered to the patient,
does not administer drugs and does not perform any life-supporting or life-sustaining functions.
The Mac-Lab System is not intended for use on unattended patients, or in situations where
diagnostic arrhythmia detection is required.
The Mac-Lab System provides the ability to transmit patient data for storage, analysis and viewing
at distributed locations within a clinical facility via network connectivity. The Mac-Lab System may
also function as a stand-alone device. The Mac-Lab System is used in a variety of hospital and
clinical settings including interventional laboratories (for example, cardiac catheterization and
radiology), operating room environments, and pre and post areas all under the direct supervision
of licensed healthcare practitioners who are responsible for interpreting the data.
CardioLab System
The CardioLab System is intended for acquiring, filtering, digitizing, amplifying, measuring and
calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients.
Clinical data may include: ECG waveforms, intracardiac signals, stimulus data, ablation data,
pulse oximetry (SpO
blood pressure. Physiological parameters such as diastolic, systolic, and mean pressures, heart
rate, and cycle length may be derived from the signal data, displayed and recorded. The data may
be entered manually or acquired via interfaced devices and/or information systems and may be
used for report generation.
Procedural information and optional anatomical and physiological imaging and data devices may
be interfaced [for example, X-ray, ultrasound, mapping systems, ablation generators (for example,
RF and cryogenic), simulators, patient monitors and information systems]. The CardioLab System
can display, store and annotate images previously acquired and stored by other systems. Data
may be provided to other systems via multiple formats (for example, HL7, DICOM, Analog
outputs). Data may be received from other devices via multiple formats (for example, DICOM,
Analog inputs).
), respiration rate, CO2 (EtCO2), temperature, and invasive and noninvasive
2
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Optional accessories for hardware and software may include research tools to be used exclusively
outside patient care settings. The purpose of the research tools is to assist researchers or
clinicians in developing algorithms.
Optional accessories for hardware and software may also include a waveform simulator to be
used exclusively outside patient care settings. The waveform simulator may be used for training,
demonstration without a patient attached, and as a troubleshooting tool in the CardioLab System.
The CardioLab System does not have alarms, does not generate energy delivered to the patient,
does not administer drugs and does not perform any life-supporting or life-sustaining functions.
The CardioLab System is not intended for use on unattended patients, or in situations where
diagnostic arrhythmia detection is required.
The CardioLab System provides the ability to transmit patient data for storage, analysis and
viewing at distributed locations within a clinical facility via network connectivity. The CardioLab
System may also function as a stand-alone device. The CardioLab System is used in a variety of
hospital and clinical settings including interventional laboratories (for example, electrophysiology
and cardiac catheterization), operating room environments, and pre and post areas all under the
direct supervision of licensed healthcare practitioners who are responsible for interpreting the
data.
ComboLab System
Introduction
The ComboLab System is the combination of both the Mac-Lab and CardioLab Systems. The
ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System,
although only one system may be used at a time. The ComboLab System executes the same
software and runs on the same hardware in the same environments as the Mac-Lab and
CardioLab Systems.
SpecialsLab System
The SpecialsLab System executes the same software and runs on the same hardware in the same
environment as the Mac-Lab System. Products designated as a SpecialsLab System support
fewer options than the Mac-Lab system.
Compliance
Non-US Mac-Lab/CardioLab systems comply with the following standards:
IEC/EN 60601-1 3rd ed Medical Electrical Equipment, Part 1 General Requirements for Basic
Safety and Essential Performance
IEC/EN 60601-1 2nd ed Medical Electrical Equipment, Part 1 General Requirements for
Safety
IEC/EN 60601-1-1 Safety requirements for medical electrical systems
IEC/EN 60601-1-2 Electromagnetic compatibility - Requirements and tests
IEC/EN 60601-1-4 Programmable electrical medical systems
NOTE: Upgrade systems may not comply with IEC/EN 60601-1 3rd ed.
2063076-010H EN Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual1-5
Introduction
US-only Mac-Lab/CardioLab systems comply with the following standards:
IEC/EN 60601-1 2nd ed Medical Electrical Equipment, Part 1 General Requirements for
Safety
IEC/EN 60601-1-1 Safety requirements for medical electrical systems
IEC/EN 60601-1-2 Electromagnetic compatibility - Requirements and tests
IEC/EN 60601-1-4 Programmable electrical medical systems
Classification
This system is classified according to IEC 60601-1 as follows:
shock
Type of protection against electrical
IEBClass IN/A
CardioLab II Plus Amplifier:
PDM Base StationClass IN/A
PDM
ECG, IBP, SpO
NBP
TRAM-RACClass IN/A
TRAM module:
ECG, IBP, SpO
NBP
Capnostat Mainstream CO
, Temp, CO
2
, Temp, CO
2
module
2
Class I
Class II
Class II CF Defib Proof
N/A BF
Degree of protection against electrical
CF Defib Proof ECG, IBP, IC ECG, Auxiliary
CF Defib Proof
BF Defib Proof
BF Defib Proof
shock
ingress of water
Degree of protection against harmful
Ordinary
IPX1
Ordinary
nitrous oxide
Mode of Operation
mixture with air or with oxygen or
presence of a flammable anesthetic
Degree of safety of application in the
Not SuitableContinuous
CapnoFlex CO
Vivid Remote TrackballN/AN/A
module
2
N/A BF
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Conventions
The following conventions are used throughout this manual.
Introduction
Bold Indicates keys on the keyboard, text to be entered or hardware items such as buttons or switches
on the equipment.
ItalicsIndicates software terms that identify menu items, buttons or options in various windows.
[Key1] + [Key2]Indicates a keyboard operation. A (+) sign between the names of two keys means press and hold
EnterPress the “Enter” or “Return” key on the keyboard. Do not type “enter”.
the first key while pressing the second key once.
For example, “Press Ctrl + Esc” means to press and hold down the Ctrl key while pressing the Esc
key.
Illustrations and Names
All illustrations in this manual are provided as examples only. They may not necessarily reflect the
setup or the data on your system.
In this manual, all names appearing in examples and illustrations are fictitious. The use of any real
person's name is purely coincidental.
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Introduction
Safety Information
Read through the following safety information before putting the system into use. Disregarding
information on safety is considered abnormal use.
The terms danger, warning and caution are used throughout this manual to point out hazards and
to designate a degree or level of seriousness.
Definitions
Hazard is defined as a source of potential injury to a person.
DANGER:IMMINENT DEATH OR SERIOUS INJURY
Danger messages indicate an imminently hazardous situation which, if not
avoided, will result in death or serious injury.
WARNING: POTENTIAL DEATH OR SERIOUS INJURY
Warning messages indicate a potentially hazardous situation which, if not
avoided, may result in death or serious injury.
CAUTION: POTENTIAL INJURY OR EQUIPMENT DAMAGE
Caution messages indicate a potentially hazardous situation which, if not
avoided, may result in minor to moderate injury or equipment damage.
NOTE: Notes provide additional user information.
Prescription Device
CAUTION: SALE OF DEVICE
U.S. federal law restricts this device to sale by or on the order of a physician.
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General
Introduction
WARNING: UNSUPERVISED USE
This device is intended for use under the direct supervision of a licensed
health care practitioner.
WARNING: This system is designed to comply with the applicable IEC/EN 60601-1 series
safety standards when connected and powered as specified. Connecting
additional devices, parts or accessories that are not recommended by GE
Healthcare could lead to a reduced level of safety. Refer to the Service Manual
for equipment connection and service information. Contact GE Healthcare if
questions arise.
WARNING: Before connecting supported interfaced devices to the system, ensure that the
devices meet the requirements of the applicable IEC 60601 series safety
standards and the system configuration meets the requirements of the IEC
60601-1-1 medical electrical systems standard.
Applicable Messages
DANGER:EXPLOSION HAZARD
Using this equipment in the presence of flammable gasses (including
anesthetics and oxygen) may cause an explosion or fire. Always use this
equipment in a well ventilated area away from the presence of potentially
flammable gasses.
WARNING: The use of unspecified accessories, transducers and cables may result in
increased emissions or decreased immunity of the system.
WARNING: Use caution when cleaning the environment near equipment. Fluid ingress may
damage devices or compromise electrical safety.
2063076-010H EN Mac-Lab/CardioLab/Centricity Cardiology INW Service Manual1-9
Introduction
WARNING: Modify equipment only as authorized by the manufacturer. After modifications,
appropriate inspection and testing must be conducted to ensure continued
safe use of the equipment.
WARNING: ELECTRICAL HAZARDS
Connect equipment only as specified in the cabling diagrams. Failure to do so
may lead to increased electrical safety risk.
WARNING: ELECTRICAL HAZARD
Power equipment only as specified. Do not connect equipment to extension
cords or multiple socket outlets.
WARNING: EQUIPMENT FAILURE
System components should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the system should be
observed to verify normal operation in the configuration in which it will be
used.
WARNING: EQUIPMENT HAZARD
Route cables through floor or ceiling conduit wherever possible. Ensure the
fiber optic cable is protected from potential sources of damage.
WARNING: EQUIPMENT HAZARD
Do not attempt to service the UPS or replace the battery. Doing so could result
in equipment damage. Contact qualified GE Service personnel for service or
replacement.
WARNING: EXPLOSION HAZARD
Do not incinerate the UPS battery or store at high temperatures.
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WARNING: FALLING EQUIPMENT
Do not place the PDM more than 147 cm (58 in) from the floor when mounting
on an IV pole with a base less than 58 cm (23 in) in diameter. This may cause
the IV pole to tip over.
WARNING: FALLING EQUIPMENT
Monitor suspension systems other than the Mavig GD60 Series have not been
validated for remote monitors.
WARNING: INACCURATE TIME
Changing the system time during a study may cause the event log not to reflect
the events as they actually happened. An apparent lag time may be introduced,
events may appear out of order or medication values could be affected. Do not
change the system time during a study. Confirm that the times between the
acquisition system and the clients are the same prior to system use.
Introduction
WARNING: SYSTEM INSTABILITY
DO NOT load any software or patches other than those specified by GE
Healthcare onto the system. Doing so may result in system instability or
failure.
WARNING: SHOCK HAZARD
Do not power unspecified devices from the system equipment outlets.
WARNING: SHOCK HAZARD
If liquids or foreign materials have entered a device, take it out of service and
have it checked by qualified service personnel to verify safety and functionality
before it is used again. Ingress of foreign substances may result in shock, fire,
excess leakage current, or device failure.
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Introduction
WARNING: SHOCK HAZARD
To ensure patient safety, all equipment connected to the system must be
powered from an isolated power source.
WARNING: SHOCK HAZARD
To reduce the risk of electric shock or damage to equipment, the equipment
must only be connected to a properly installed power outlet with protective
ground contacts.
WARNING: SHOCK HAZARD
To reduce the risk of shock and equipment damage, use safe working practices
when servicing electrical equipment.
WARNING: SHOCK HAZARD
Damaged cables and loose connections present a shock hazard and could
cause signal noise or impaired device operation. Ensure all cables are in good
condition and securely connected before powering on equipment. Replace
damaged cables immediately.
WARNING: SHOCK HAZARD
Use caution when cleaning the environment near equipment. Fluid ingress may
damage devices or compromise electrical safety.
WARNING: SHOCK HAZARD
Do not connect analog input or analog output cables to patient-isolated
equipment interfaces. This could compromise patient safety.
WARNING: SHOCK HAZARD
The Patient (sink) Leakage Current test causes high voltages on the test body.
Do not touch conductive regions of the safety analyzer.
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WARNING: SHOCK HAZARD
To fully isolate the equipment from mains power, disconnect the power cord
from the mains supply.
WARNING: SHOCK HAZARD
To reduce the risk of ingress of water into the equipment, do not mount the
PDM in a vertical position with the patient cables facing up or down.
WARNING: SHOCK HAZARD
The CardioLab II Plus amplifier defibrillation protection is only guaranteed
when approved accessories are used. Do not use unspecified accessories.
Introduction
WARNING: SYSTEM INSTABILITY
Do not install or use unvalidated anti-virus software (including unvalidated
versions). Doing so may result in system instability or failure. Use only
validated anti-virus software in the appropriate language version.
WARNING: SYSTEM INSTABILITY
Do not install any third party software onto the system, unless specified by
GEHealthcare. Doing so may result in system instability or failure.
WARNING: TIPPING HAZARD
Do not attempt to transport the Mobile Workstand while the wheels are locked.
WARNING: TRIPPING HAZARD
Keep cables away from accessible walkways. Failure to do so may present a
tripping hazard and could result in cable damage.
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Introduction
CAUTION: EQUIPMENT DAMAGE
Swivel tension nut on the Mobile Workstand must be torqued to a minimum of
20 in-lbs [2.3 N-m].
CAUTION: EQUIPMENT DAMAGE
Tilt tension screws on the Mobile Workstand must be torqued to a minimum of
35 in-lbs [4.0 N-m].
CAUTION: EQUIPMENT DAMAGE
Do not use benzene, thinner, ammonia, or any other volatile substances to
clean the monitor or the screen. These chemicals may damage the cabinet
finish as well as the screen.
CAUTION: EQUIPMENT DAMAGE
Do not use OA cleaner as it will cause deterioration or discolor the LCD
surface.
CAUTION: LOSS OF FUNCTION
Do not edit or change the original dcf files. They may be needed in the future.
Always create a copy of the original dcf file to work on.
CAUTION: SYSTEM FAILURE
To ensure an adequate system power supply, GE Healthcare recommends
using a dedicated circuit to power the IEB.
CAUTION: SYSTEM INSTABILITY
All networked systems at a location must be on the same version of Mac-Lab/
CardioLab software. Failure to do so may result in slowed performance, data
corruption, or system instability.
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Responsibility of the Manufacturer
GE Healthcare is responsible for the effects of safety, reliability and performance only if:
Assembly operations, extensions, readjustments, modifications or repairs are carried out by
persons authorized by GE Healthcare.
The electrical installation of the relevant room complies with the requirements of the
appropriate regulations.
The equipment is used in accordance with the instructions for use.
Responsibility of the User
General
Keep this manual with the equipment at all times. Periodically review this manual for information
regarding system operation. If further assistance is required, contact GE Healthcare.
Anti-Virus Software
Introduction
The following should be noted regarding the use of anti-virus software. Refer to the Mac-Lab/
CardioLab Security Guide (PN 2063076-004) for further information.
Anti-virus software is not provided with the Mac-Lab/CardioLab system and it is the customer’s
responsibility to acquire, install and maintain.
The customer is responsible for updating anti-virus definition files.
If a virus is found, contact the facility System Administrator and GE Technical Support.
The anti-virus software used must be one that has been validated by GE Healthcare.
The language version of the anti-virus software must match the operating system language.
Product Vulnerability and Security Patches
Customers are responsible to stay informed on the Mac-Lab/CardioLab product vulnerability
status and the installation of validated security patches for the Mac-Lab/CardioLab systems. Refer
to the Mac-Lab/CardioLab Security Guide (PN 2063076-004) for further information.
Preventative Maintenance
It is the responsibility of the user to properly maintain the system equipment. Refer to Maintenance
on page 3-1 in this manual and the accompanying service manual for further information.
Failure on the part of the responsible individual, hospital or institution using this equipment to
implement a satisfactory maintenance schedule may cause undue equipment failure and possible
health hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the Mac-Lab/CardioLab
system will always be functional when required. In the event that service is needed for the
equipment, contact your GE Healthcare service representative.
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Introduction
Service
Refer equipment servicing to GE Healthcare authorized service personnel only. Any unauthorized
attempt to repair equipment under warranty voids that warranty.
Any unauthorized attempt to install third-party software on a system under warranty, voids that
warranty.
It is the user’s responsibility to report the need for service to GE Healthcare or to one of their
authorized agents.
Equipment Symbols
Equipment SymbolsDescriptions
PCT (GOST-R) Mark
Compliance with applicable requirements for Russia.
Underwriters Laboratories, Inc.
Non-US Systems:
Medical – general medical equipment as to electrical shock, fire and mechanical hazards only
in accordance with UL60601-1, CAN/CSA C22.2 No. 601.1, ANSI/AAMI ES60601-1 (2005,
3rd ed.), AND CAN/CSA-C22.2 No. 60601-1 (2008).
US-Only Systems:
Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical
and other specified hazards, only in accordance with UL 2601-1, CAN/CSA C22.2 No. 601.1,
IEC 60601-1 and IEC 60601-1-1.
WEEE
Indicates that the waste of electrical and electronic equipment must not be disposed as
unsorted municipal waste and must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning the decommissioning of your
equipment.
WEEE
The separate collection symbol is affixed to a battery, or its packaging, to advise you that the
battery must be recycled or disposed of in accordance with local or country laws. The letters
below the separate collection symbol indicate whether certain elements (Pb=Lead,
Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the
environment and human health, it is important that all devices with batteries are properly
recycled or disposed.
Information on the potential effects on the environment and human health of the substances
used in batteries is available at this url: