SEER Light/SEER Light Extend Compact Digital Holter Recorder
SEER Light/SEER Light Extend Controller
SEER Light Connect
NOTE: The information in this manual only applies to SEER Light devices software version 1. It does not
apply to earlier software versions. Due to continuing product innovation, specifications in this manual are
subject to change without notice.
Marquette®, MARS®, MUSE®, and SEER® are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going to market as GE Healthcare. All other marks are owned by
their respective owners.
1-2SEER Light Ambulatory Recorder/ControllerRevision B
2019818-008
Introduction: Manual Information
Manual Informatio n
Revision History
Each page of the document has the document part number followed by a
revision letter at the bottom of the page. This letter identifies the
document’s update level. The latest letter of the alphabet corresponds to
the most current revision of the document.
The revision history of this document is summarized in the table below.
Table 1. Revision History 2019818-008
RevisionDateComment
A15 May 2005Initial release of manual.
B15 July 2005Manual updated for clarity.
Manual Purpose
Definitions
This manual supplies technical information for service representative
and technical personnel so they can maintain the equipment. Use it as a
guide for maintenance and electrical repairs considered field repairable.
Where necessary the manual identifies additional sources of relevant
information and or technical assistance.
See the operator manual for the instructions necessary to operate the
equipment safely in accordance with its function and intended use.
Items shown in Black text are keys on the keyboard, text to be
entered, or hardware items such as buttons or switches on the
equipment.
Items shown in Italicized text are software terms which identify
menu items, buttons, or options in various windows.
To perform an operation which appears with a plus (+)sign between
the names of two keys, you press and hold the first key while
pressing the second key once. This is called a keystroke combination.
For example, “Press Ctrl + Esc” means to press and hold down the
Ctrl key while pressing the Esc key.
When instructions are given for typing a precise text string with one
or more spaces, the point where the spacebar must be pressed is
indicated as:
you press the spacebar when required.
The SEER Light recorder is a two and three channel digital Holter ECG
recorder that records the electrical signals associated with cardiac
activity fo r 24 or 48 h our s . It i s u se d in diagnosing card i ac a bno r mal i t ie s
and revealing trends or changes in heart function. This device is for the
use of trained personnel only.
This device is not intended for use on infants weighing less than 10 kg
(22 lbs).
Definitions
The terms danger, warning, and caution are used throughout this
manual to point out hazards and to designate a degree or level of
seriousness. Familiarize yourself with their definitions and significance.
Introduction: Safety Information
Warnings
Hazard is defined as a source of potential injury to a person.
DANGER indicates an imminent hazard which, if not avoided, will
result in death or serious injury.
WARNING indicates a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
CAUTION indicates a potential hazard or unsafe practice which, if not
avoided, could result in minor personal injury or product/property
damage.
NOTE provides application tips or other useful information.
WARNINGS
ACCIDENTAL SPILLS — If liquids have entered a
device, take it out of service and have it checked by a
service technician before it is used again. To avoid
electric shock or device malfunction liquids must not be
allowed to enter the device.
CABLES — To avoid possible strangulation, route all
cables away from patient's throat.
CARDIAC APPLICATION — This device cannot be used
for direct cardiac application.
CONDUCTIVITY — Keep the conductive parts of lead
electrodes and associated parts away from other
conductive parts, including earth.
DEFIBRILLATOR PRECAUTIONS — Do not come into
1-6SEER Light Ambulatory Recorder/ControllerRevision B
2019818-008
Introduction: Safety Information
contact with patients during defibrillation. Otherwise,
serious injury or death could result. Patient signal inputs
labeled with the CF and BF symbols wi th paddles are
protected against damage resulting from defibrillation
voltages. To ensure proper defibrillator protection, use
only the recommended cables and leadwires. Proper
placement of defibrillator paddles in relation to the
electrodes is required to ensure successful defibrillation.
ELECTROSURGERY — If an electrosurgery device is
used, it is necessary to disconnect the patient cable from
the SEER Light recorder. Take precautions to reduce
risks of burns and injury to the patient.
LEAKAGE CURRENT — Electrical shock to patient
could result from component failure and lack of power
isolation.
In the event this syste m is used in the patient vicinity, it
must be configured in such a way that it and all of its
electrically-connecte d peripheral devices ar e isolated from
mains power to prevent excessive leakage current to the
patient. This can be accomplished through the use of
isolated mains power, or a medical grade isolation
transformer (in compliance with UL 60601, CAN/CSA
C22.2 No. 601.1, IEC 60601-1) with this system. All nonmedical peripheral devices shall comply with IEC and ISO
safety standards that are relevant to that equipment (i.e.,
IEC 60950, UL 60950).
Cautions
Use of the SEER Light Connect device in the patient
vicinity requires that these measures are observed.
PACEMAKER PATIENTS — Take precautions to avoid
risks of hazard due to the operation of a cardiac
pacemaker or other electrical stimulators.
SUPERVISED USE — This device is intended for use
under the direct supervision of a licensed health care
practitioner.
CAUTIONS
RESTRICTED SALE — U.S. federal law restricts this
device to sale by or on the order of a physician.
BEFORE OPERATION — Check that the instrument
operates properly.
DISPOSAL — At the end of its service life, the product
described in this manual, as well as its accessories, must
be disposed of in compliance with local, state, or federal
guidelines regulating the disposal of such products. If you
have questions concerning dispos al of the product , please
contact GE or its representatives.
MODIFICATIONS — Do not make an y modifications to
the device.
AFTER DEVICE USE — Clean the device after each use
to ensure trouble-free op eration for the next use.
Use a piece of damp cloth with alcohol to clean the
device and the patient cable.
The device cannot be sterilized.
Do not use xylene and petrol related liquid for
cleaning the device.
To ensure proper operation of the device, it is
necessary to periodically have the device checked by
authorized service personnel.
Check the patient cable and connectors every month
by connecting them to an ECG simulator.
Serial Number
INSTALLATION — Adhere to the following
recommendations during installation:
Install and keep device away from splashing water.
Do not install the device where it may be affected by
humidity, ventilation, direct sunlight, air
conditioning, dust, salt, sulfur, etc.
Prevent the device from ti lting, and protect it from
the possibility of vibration or shock.
Do not install the device in a chemical storage area or
where gas is generated.
Every GE Medical Systems Information Technologies device has a
unique serial number for identification. The serial number appears on
the device label similar to the one shown below
.
50
1-8SEER Light Ambulatory Recorder/ControllerRevision B
2019818-008
Disposal of the Device
Introduction: Safety Information
When disposing the device, follow the applicable national rules and
regulations of disposal of medical equipment.
When disposing the recyclable battery, follow the applicable national
rules and regulations concerning the environmental issues.
GE is responsible for the effects of safety, reliability, and performance
only if:
Assembly operations, extensions, readju stments, modifications, or
repairs are carrie d out by persons aut horized b y GE Medica l Systems
Information Technologies.
The equipment is used in accordance with the instructions for use.
General
Refer equipment servicing to GE authorized service personnel only. Any
unauthorized attempt to repair equipment under warranty voids that
warranty.
It is the user’s respons ibility t o report the need for se rvice to GE or to one
of its authoriz ed agents.
This device is intended for use under the direct supervision of a licensed
health care practitioner.
To ensure patient safety, use only parts and access ories manufactured or
recommended by GE.
Contact GE for information before connecting any devices to this
equipment that are not recommended in this manual.
Parts and accessories used must meet t he requireme nts of t he appli cable
IEC 60601 series sa fety st andard s, and/ or t he sy stem co nfigura tion mus t
meet the requirements of the IEC 60601-1-1 medical electrical systems
standard.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been
performed in accordance with the appropriate IEC 60601-1 and/or
IEC 60601-1-1 harmonized national standard.
1-10SEER Light Ambulatory Recorder/ControllerRevision B
2019818-008
Introduction: Responsibility of the Manufacturer
Information Technology Equipment
The hardware components supplied by GE for the MARS® Holter
analysis workstation, on which the SEER Light Connect application
runs, are considered to be Information Technology Equipment (ITE).
These individual components have been found to comply with the
standard for Safety of Information Technology Equipment, including
Electrical Business Equipment EN60950 (UL 60950).
The software used in the MARS® Holter analysis workstation is
considered as medical software. The software has been designed and
manufactured to the appropriate medical regulations and controls.
In order for the MARS® Holter analysis workstation to comply with
medical equipment standard leakage current requirements, a medical
grade uninterruptible power supply (UPS) must be used (UL 60601-1,
CSA 22.2 No. 60601-1, EN 60601-1) to power all non-medical equipment.
In addition, non-medical electrical equipment must comply with IEC and
ISO safety standards that are relevant to that equipment (i.e., IEC
60950, Safety of Information Technology Equipment.)
The following symbols may appear on the equipment.
Attention. Consult accompanying documents.
Event.
This symbol indicates the polarity orientation that each battery should have when you insert it
into the unit. This unit requires you to insert the batteries so that the polarities are oriented in
alternating directions.
Power.
Introduction: Equipment Symbols
Stop.
Input connector.
Output connector.
This symbol 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.
1-12SEER Light Ambulatory Recorder/ControllerRevision B
2-2SEER Light Ambulatory Recorder/ControllerRevision B
2019818-008
SEER Light/SEER Light Extend Recorder: Component Names and Locations
Component Names and Locations
Structure
The SEER Light ambulatory recorder is shown and described below.
A B
.60 in.
(15 mm)
I
H
G
2.17 in.(55 mm)
F E D
Table 3. SEER Light Ambulatory Recorder
ItemNameDescription
AREC LEDTo display operation conditions:
After pressing the start/event button, the LED will flash twice per second for three
minutes. During this time data is not recorded.
During reco rding, the LED will flash every second.
C
3.35 in.
(85 mm)
J
017A
B
start/event button
Use to start recording.
Use to mark events during recording.
Cbattery compartment coverSlide the cover to open and set the batteries in the battery compartment.
D
A data output
For transfer of data to the SEER Light controller or to the SEER Light Connect device.
connector
Eaccess LEDWill flash during communication with the SEER Light controller.
Finfrared terminal (I.R. Window) Used to receive the signal from the SEER Light controller to begin ECG recording.
Used to receive patient information and ECG recording starting time.
Used to confirm the ECG waveform recorded by the recorder (ECG preview).
G
B output connector
Not used.
HDATA LEDThe LED flashes while transferring data to the SEER Light controller.