GE SEER 1000 User manual

GE Healthcare
SEER™ 1000 ECG Recorder and Mobile Application
English
© 2014 General Electric Company
All Rights Reserved
SEER™ 1000
ECG Recorder and Mobile Application
Operating Manual
Version 1.0
2067634-077 Revision B

2 SEER™ 1000 2067634-077 Revision B
08 April 2014
Publication Information
The information in this manual applies only to the SEER™ 1000 ECG Recorder and Mobile Application Version 1.0. It
does not apply to earlier versions. Due to continuing product innovation, specifications in this manual are subject to
change without notice.
This manual is developed and owned by GETEMED Medizin- und Informationstechnik AG, Oderstr. 77, 14513 Teltow,
Germany, and it is branded by GE Healthcare.
SEER and MARS are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Com-
pany going to market as GE Healthcare.
CardioDay is a trademark owned by GETEMED AG.
iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. “Made for iPod,”
“Made for iPhone,” and “Made for iPad” mean that an electronic accessory has been designed to connect specifically
to the iPod, iPhone, or iPad, respectively, and has been certified by the developer to meet Apple performance stand-
ards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards.
Please note that the use of this device with an iPod, iPhone, or iPad may affect wireless performance.
Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the Uni ted States
and/or other countries.
This product complies with the regulatory requirements concerning medical devices from the following bodies:
Revision History
The document part number and revision appear at the bottom of each page. The revision identifies the document’s
update level. The revision history of this document is summarized in the following table.
Revision
Publication Date
Description
A
15 July 2013
Initial release
B
08 April 2014
Modified: “Basic Information on Wireless Bluetooth Connection”
Contact your local GE Healthcare representative for related product manuals.

2067634-077 Revision B SEER™ 1000 3
Contents
1Introduction...................................................................................................................9
Intended User.............................................................................................................. 10
Indications for Use..................................................................................................... 10
Intended Use ............................................................................................................... 10
Contraindications ....................................................................................................... 10
Prescription Device Statement................................................................................ 10
Regulatory and Safety Information ....................................................................... 10
Safety Conventions....................................................................................... 11
Safety Hazards............................................................................................... 11
Medical Device Classification ..................................................................... 16
Certification .................................................................................................... 17
Input Signal Reproduction Accuracy ........................................................ 17
EMI/EMC/RF Caution..................................................................................... 17
Biocompatibility ............................................................................................. 18
Supply and Accessory Information ........................................................... 19
Manufacturer Responsibility....................................................................... 19
Product and Package Information............................................................ 19
Equipment Identification .......................................................................................... 26
Product Label................................................................................................. 26
Serial Number Format and Product Code............................................... 27
Service Information ................................................................................................... 27
Service Requirements .................................................................................. 27
Warranty Information .................................................................................. 28
Additional Assistance ................................................................................... 28
Manual Information ................................................................................................... 28
Manual Purpose............................................................................................. 28
Document Conventions ............................................................................... 28
Related Documents ...................................................................................... 30

4 SEER™ 1000 2067634-077 Revision B
2Product Overview ..................................................................................................... 31
Recorder and Application –General...................................................................... 31
Operating Elements of the Recorder ..................................................................... 32
Event Button................................................................................................... 33
Event Button LED........................................................................................... 34
Hookup Guidance LED................................................................................. 34
Audible Notifications .................................................................................... 35
3Preparing the Recording......................................................................................... 37
Instructing the Patient............................................................................................... 38
Safety Precautions ........................................................................................ 38
Recording Diary ............................................................................................. 38
Marking a Patient Event............................................................................... 39
Preparing the Patient's Skin..................................................................................... 39
Placing the Electrodes............................................................................................... 40
Electrode Placement with 7 Leads for 3-Channel Recordings .......... 41
Electrode Placement with 5 Leads for 2-Channel Recordings .......... 42
Electrode Placement with 3 Leads for the Recording of
3 Non-Independent ECG Channels ........................................................... 43
Connecting the ECG Cable to the Recorder and to the Electrodes ................ 44
Inserting a Battery ..................................................................................................... 45
Reattaching or Replacing the Battery Compartment Door.............................. 46
Switching on the Recorder....................................................................................... 46
Starting the Recording .............................................................................................. 47
Auto-Start........................................................................................................ 47
Auto-Switch-off.............................................................................................. 48
4After Completing the Recording........................................................................... 49
Switching Off Before the Recording Duration Has Been Reached ................. 49
Removing the Electrodes.......................................................................................... 50
Transferring the ECG Data to a PC......................................................................... 50
Compatible Evaluation Software............................................................... 50

2067634-077 Revision B SEER™ 1000 5
5Applications (Apps) –General Information ....................................................... 51
Functionality ................................................................................................................ 52
Data Protection........................................................................................................... 53
App Data Protection ..................................................................................... 53
Recorder Data Protection............................................................................ 53
Basic Information on Wireless Bluetooth Connection....................................... 54
6Using the Apple iOS App......................................................................................... 57
Installing and Setting up the App........................................................................... 57
Installing and Starting the App .................................................................. 57
Changing the Administrator Password.................................................... 58
Add Technician or Reset Technician Password...................................... 59
Reset Application........................................................................................... 60
Starting the App and Changing the Technician Password............................... 61
Patient Hookup........................................................................................................... 62
Add or Select a Patient................................................................................. 63
Find Device ..................................................................................................... 63
Electrode Placement and Waveform Preview........................................ 64
Verify or Change Settings............................................................................ 65
Start the Recording....................................................................................... 66
Patients Tab................................................................................................................. 67
Devices Tab.................................................................................................................. 68
7Using the Microsoft Windows App ...................................................................... 69
Installing and Setting up the App........................................................................... 69
Hardware Specifications ............................................................................. 69
Using the Bluetooth Adapter ...................................................................... 70
Installing and Starting the PC App ............................................................ 70
Removing the PC App................................................................................... 71
Changing the Administrator Password.................................................... 71
Add Technician or Reset Technician Password...................................... 72
Reset Application........................................................................................... 73
Starting the App and Changing the Technician Password............................... 74
Patient Hookup........................................................................................................... 76
Add or Select a Patient................................................................................. 76

6 SEER™ 1000 2067634-077 Revision B
Electrode Placement and Waveform Preview........................................ 78
Verify or Change Settings............................................................................ 79
Start the Recording....................................................................................... 80
Patients Tab................................................................................................................. 80
Devices Tab.................................................................................................................. 81
8Troubleshooting ........................................................................................................ 83
Recorder Troubleshooting........................................................................................ 83
Application Troubleshooting.................................................................................... 85
Bluetooth Troubleshooting ...................................................................................... 89
Bluetooth Messages from the Microsoft Windows System............................. 90
Resetting the Recorder with the Microsoft Windows App................................ 90
How to Notify Service if the Recorder is Defective ............................................. 91
9Maintenance............................................................................................................... 93
Notices.......................................................................................................................... 93
Cleaning and Disinfecting the Recorder ............................................................... 94
Cleaning the Carrying Pouch................................................................................... 95
Cleaning, Disinfecting, and Storing ECG Cables.................................................. 95
Cleaning ECG Cables .................................................................................... 95
Disinfecting ECG Cables............................................................................... 96
Storing ECG Cables....................................................................................... 96
Cleaning the Battery Contacts................................................................................ 96
Checking ECG Cable and Connectors.................................................................... 96
ASpecifications ............................................................................................................. 97
General ......................................................................................................................... 97
Electrical ....................................................................................................................... 98
Mechanical................................................................................................................... 98
Environmental............................................................................................................. 99
Bluetooth module....................................................................................................... 99

2067634-077 Revision B SEER™ 1000 7
EMC Specifications according to IEC 60601-1-2 ..............................................100
General Specifications, Table 201...........................................................100
General Specifications, Table 202 ...........................................................101
Non Life-Sustaining Systems, Table 204................................................102
Recommended Separation Distances from Portable and
Mobile RF Communications Equipment, Table 206.............................103
BIndex ...........................................................................................................................105

1
2067634-077 Revision B SEER™ 1000 9
1Introduction
This document describes the SEER™ 1000 ECG Recorders and Mobile
Applications, also referred to as the “systems”, “devices”, or “products”.
This manual is intended for an operator of the devices.
There are three SEER 1000 ECG recorders, which differ in the maximum
duration of the ECG recording and the color of the front panel:
24 hour (blue)
48 hour (purple)
7 day* (green)
*The MARS Holter Analysis System supports the collection of up to three days of ECG data.
All three SEER 1000 ECG recorders are suitable for use with both adult and
pediatric patients (including those patients weighing less than 10 kg).
Please refer to the manual of your Holter analysis software for restrictions.
There are two applications, one which is available as an Apple iOS app
and one which is available as a stand-alone software app under Microsoft
Windows operating systems. Both can be used during the patient hookup
phase to download patient demographic data to a recorder, visually in-
spect the ECG waveforms, change recorder settings, and start the record-
ing. Use of these applications is optional.
This chapter provides general information required for the proper use of
the products and this manual. Familiarize yourself with this information
before using the products.

Introduction
10 SEER™ 1000 2067634-077 Revision B
Intended User
The devices are intended to be used by trained operators under the direct
supervision of a licensed healthcare practitioner in a hospital or medical
professional’s facility.
Indications for Use
The SEER 1000 is a Holter recorder which is indicated for patients who
may benefit from a long-term continuous electrocardiographic (ECG) re-
cording, including, but not limited to, those with complaints of palpita-
tions, syncope, chest pain, shortness of breath, or those that need to be
monitored to judge their current cardiac functionality.
Intended Use
The SEER 1000 digital Holter recorder is intended to continuously record
ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-
tended to be used with an ECG analysis software package. The recorded
data are downloaded to a PC for analysis and subsequent evaluation by a
trained physician or healthcare professional.
Contraindications
There are no known contraindications to using these devices.
Prescription Device Statement
CAUTION
United States federal law restricts this device to sale by, or on the or-
der of, a physician.
Regulatory and Safety Information
This section provides information about the safe use and regulatory com-
pliance of this system. Familiarize yourself with this information, and read
and understand all instructions before attempting to use this system. The
system software is considered medical software. As such, it was designed
and manufactured to the appropriate medical regulations and controls.

Introduction
2067634-077 Revision B SEER™ 1000 11
NOTE
Disregarding the safety information provided in this manual is consid-
ered abnormal use of this system and could result in injury, data loss,
or a voided warranty.
Safety Conventions
A Hazard is a source of potential injury to a person or damage to property
or the system.
This manual uses the terms DANGER, WARNING, CAUTION, and NOTICE to
point out hazards and to designate a degree or level of seriousness. Fa-
miliarize yourself with the following definitions and their significance.
Definition of Safety Conventions
Convention
Definition
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 moderate or minor injury.
NOTICE
Indicates a potential hazard or unsafe practice, which, if
not avoided, could result in the loss or destruction of
property or data.
Safety Hazards
The following messages apply to the system as a whole. Specific mes-
sages may also appear elsewhere in the manual.
WARNINGS
WARNING
NO MONITORING DEVICE –The SEER 1000 recorder is not a monitor-
ing device and is not intended for monitoring the clinical condition of
a patient.
Do NOT use the SEER 1000 as a monitoring device.

Introduction
12 SEER™ 1000 2067634-077 Revision B
WARNING
MIXING UP RECORDINGS –The patient’s life or health may be put at
risk if the patient is assigned a different patient’s examination, thus
resulting in an incorrectly assigned diagnosis.
Take special care to always select the correct examination and the
correct patient. To ensure that a recording is not assigned to the
wrong patient, always enter the patient’s ID into the recording me-
dium or write the patient’s ID on it before starting the recording.
WARNING
ELECTROSURGERY –There is a risk of burns and injury to the patient.
If an electrosurgery device is used, disconnect the ECG cable from the
recorder.
WARNING
EXPLOSION HAZARD –Electrical sparks can cause explosions in the
presence of certain gases.
Do not use device in an oxygen-enriched environment or around
other flammable or explosive gases.
Establish whether the patient is liable to be in such an environment,
possibly for job-related reasons.
WARNING
CABLES –Cables present a possible strangulation hazard.
To avoid possible strangulation, route all cables away from patient's
throat. Use short version of cables for pediatric patients.
WARNING
CONDUCTIVITY –Electric shock or device malfunction may occur if
electrodes contact conductive materials.
Keep the conductive parts of lead electrodes and associated parts
away from other conductive parts, including earth. Also make sure
that no contact to other conductive parts is possible if the electrodes
loosen during recording.

Introduction
2067634-077 Revision B SEER™ 1000 13
WARNING
GENERAL DANGER TO THE PATIENT –Instructions listed in this manual
in no way supersede established medical practices concerning pa-
tient care.
Perform the established medical practices under all circumstances.
WARNING
RISK OF CONTAMINATION OR INFECTION –Recorder and accessories
may be contaminated with bacteria or viruses after use.
If any contamination of the recorder or accessories has occurred, ob-
serve the standard procedures for handling contaminated objects
and the following precautions:
oUse protective gloves to handle the equipment.
oIsolate the material by using suitable packaging and labeling.
oContact the addressee before sending the equipment.
oClean the recorder and accessories after every use. For infor-
mation, refer to the chapter “Maintenance” on page 93.
WARNING
RISK OF CHOKING –Packaging material can pose a choking hazard.
Keep packaging material out of children's reach.
CAUTIONS
CAUTION
INFECTION RISK –Reuse of disposable parts that come into contact
with patients pose a risk of infecting patients.
Do not reuse disposable parts that have had direct contact with the
patient, such as ECG electrodes.
CAUTION
INFECTION RISK –Returning parts and products that have not been
disinfected exposes our service personnel to a risk of infection.
Especially to help protect our service personnel, please disinfect the
recorder and ECG cable before returning them to us for inspection or
maintenance.

Introduction
14 SEER™ 1000 2067634-077 Revision B
NOTICES
NOTICE
CABLE DAMAGE –Bending or wrapping the cable can damage it.
When attaching and affixing the ECG cable, make sure not to bend it
excessively. Avoid coiling the ECG cable around the recorder, as this
can damage the cable.
NOTICE
DAMAGE TO THE DEVICE THROUGH BATTERY LEAKAGE –Batteries
may leak if left in an unused device for prolonged periods.
If you intend to store the device for longer than one week, remove the
battery from it.
NOTICE
INSUFFICIENT RECORDING QUALITY –Lack of proper patient prepara-
tion can cause unsatisfactory ECG quality.
Prepare the patient for the recording as described in the chapter
“Preparing the Recording” on page 37.
NOTICE
INSUFFICIENT RECORDING QUALITY –Defective devices and accesso-
ries can cause unsatisfactory ECG quality.
Visually inspect the recorder and the ECG cable every time before
connecting the recorder and the electrodes to the patient.
NOTICE
MALFUNCTION OR DAMAGE OF THE DEVICE –Changes in temperature
and humidity can cause condensation inside the recorder.
Wait at least two hours after the externally visible dampness of the
recorder has disappeared before reusing it.
NOTICE
DAMAGE TO THE DEVICE –You may only open the battery compart-
ment of the recorder.
Do not use force when handling the recorder.

Introduction
2067634-077 Revision B SEER™ 1000 15
NOTICE
SAFETY ONLY WITH APPROVED ACCESSORIES –Safe and reliable oper-
ation of the device is only possible when using the supplied and ap-
proved accessories.
Observe the information contained in this manual, in the supplies or
accessories manual, and in the instructions provided with accessories.
NOTICE
SAFETY AND RELIABILITY ONLY WITH PROPER MAINTENANCE –Proper
maintenance is vital for long-term safety and reliability of the recorder.
Observe the information contained in the “Maintenance” chapter on
page 93.
NOTICE
DAMAGE TO DEVICE AND ACCESSORIES –Unauthorized personnel do
not have the proper training to repair the device. Repairs carried out
by unauthorized personnel could result in damage to the device or
accessories.
Send the device for inspection to an authorized facility if you find or
even suspect a malfunction. Please add a detailed description of the
observed malfunction.
NOTICE
DIFFICULTIES FINDING CAUSES FOR MALFUNCTIONS –To find and re-
pair a malfunction, both recorder and ECG cable are needed.
Remember to include the ECG cable when returning the recorder for
service or repair. (Avoid wrapping the ECG cable around the recorder,
as this can damage the cable.)
Always use the same ECG cable with a recorder. If an institution has
several recorders and ECG cables, try to ensure that each recorder is
matched with a specific ECG cable. In this way, cable or recorder fail-
ures can be isolated and eliminated faster.

Introduction
16 SEER™ 1000 2067634-077 Revision B
NOTICE
ADVERSE ENVIRONMENTAL IMPACT –Electrical devices and accessories
contain metal and plastic parts that have to be disposed of properly.
Dispose of the device and its accessories in accordance with applica-
ble local and national waste regulations after the product’s lifetime
has expired.
If you have questions concerning the disposal of this product, contact
GE Healthcare or a facility authorized by GE Healthcare.
NOTICE
POSSIBLE LOSS OF ECG RECORDING OR POOR SIGNAL QUALITY –The
recorder might be used with insufficient results if the patient does not
have all relevant information.
It is the responsibility of the medical doctor to provide the patient with
the information required for the ECG recording. See “Instructing the
Patient” on page 38 for more information.
NOTICE
INTERFERENCE –Electrical emissions from an electric blanket may de-
grade signal quality.
Do not use in conjunction with an electric blanket.
Medical Device Classification
This device is classified as follows, according to IEC 60601-1:
Medical Device Classification
Category
Classification
Type of protection against electrical
shock
Class I internally powered equipment.
Degree of protection against elec-
trical shocks
Type CF non-defibrillation-proof ap-
plied part.
Degree of protection against harm-
ful ingress or water
The ingress protection classification of
the recorder is IP43, whereby
4 = Protection against objects > 1 mm
(0.04 inches)
3 = Protection against spraying water

Introduction
2067634-077 Revision B SEER™ 1000 17
Category
Classification
Degree of safety of application in
the presence of a flammable anes-
thetic mixture with air or with oxy-
gen or with nitrous oxide
Equipment is not suitable for use in the
presence of a flammable anesthetic
mixture with air or with oxygen or with
nitrous oxide.
Method(s) of sterilization recom-
mended by the manufacturer
Not applicable
Mode of operation
Continuous operation.
Certification
Medical Equipment
With respect to electric shock, fire, and mechanical and
other specified hazards only in accordance with
IEC 60601-1, CAN/USA C22.2 NO. 601.1, IEC 60601-1-2,
and IEC 60601-2-47
Input Signal Reproduction Accuracy
The frequency response meets the following IEC 60601-2-47 Part 51.5.9
requirements:
The response of the recorder to a 5 mV 100 ms rectangular pulse
does not show a baseline amplitude displacement after the pulse of
more than 0.1 mV referred to the baseline before the pulse. The slope
outside the pulse is less than 0.3 mV/s. The leading edge overshoot is
less than 10%.
The responses to all pulses of a 1.5 mV, 40 ms triangular pulse train,
which simulates a series of narrow R-waves, is within 80% to 110% of
the response to a train of 1.5 mV, 200 ms triangular pulses.
EMI/EMC/RF Caution
This system is designed and tested to comply with applicable regulations
regarding EMC. Changes or modifications to this system not expressly ap-
proved by manufacturer could cause EMC issues with this or other equip-
ment.

Introduction
18 SEER™ 1000 2067634-077 Revision B
Radio Frequency (RF) devices may interfere with the use or accuracy of
the device or system. When installing or using the device or system, be
aware of the proximity of known RF sources, such as:
Radio and TV stations
Portable and mobile RF communication devices (cell phones, two-way
radios)
X-ray, CT, or MRI devices.
These devices are also possible sources of interference as they may
emit higher levels of electromagnetic radiation.
WARNING
EQUIPMENT MALFUNCTION —Use of portable phones or other radio fre-
quency (RF) emitting equipment near the system may cause unexpected
or adverse operation.
Do not use unauthorized portable phones or other electronic equipment
that may emit radio frequency (RF) near this system.
WARNING
ACCESSORIES/COMPONENTS —Adding accessories or components, or
modifying the medical device or system, may result in increased EMIS-
SIONS or decreased IMMUNITY of the device or system.
Use the following resources for more information on EMI/EMC and RF
concerns:
The Supplies and Accessories Reference Guide for your system
GE Healthcare or GE Healthcare authorized representatives
The Electromagnetic Compatibility appendix in this operator’s manual
Biocompatibility
The parts of the system described in this manual, including all accessories
that come into contact with the patient during the intended use, fulfill the
biocompatibility requirements of the applicable standards. If you have
questions in this matter, contact your GE Healthcare representative.

Introduction
2067634-077 Revision B SEER™ 1000 19
Supply and Accessory Information
For ordering information and a list of supplies and accessories that have
been approved for use with this device, see the SEER 1000 Supplies and
Accessories Reference Manual that is supplied with each recorder.
Manufacturer Responsibility
The manufacturer is responsible for the effects of safety, reliability, and
performance only if the following conditions are met:
Assembly operations, extensions, readjustments, modifications, or re-
pairs are carried out by persons authorized by GE Healthcare.
The electrical installation of the relevant room complies with the re-
quirements of the appropriate local, state, and other government reg-
ulations.
The equipment is used in accordance with the instructions for use.
GE Healthcare is contacted for information before any devices that
are not recommended in this manual are connected to the equip-
ment.
Product and Package Information
This section describes the location of the labels used on your device and
its packaging. It also describes the symbols used on the labels.
Symbols
The following symbols may appear on the device or its packaging. Famili-
arity with these symbols assists in the safe use and disposal of the equip-
ment. For equipment symbols not shown, refer to the original equipment
manufacturers (OEM) manuals.
Symbols are used to convey warnings, cautions, prohibitions, mandatory
actions, or information. Any hazard symbol on your device or packaging
with markings in color indicates there is certain danger and is a warning.
Any hazard symbol on your device or packaging that is in black and white
indicates a potential hazard and is a caution.

Introduction
20 SEER™ 1000 2067634-077 Revision B
Symbol
Description
Catalog or Orderable Part Number
Indicates the manufacturer's catalog or part number.
Serial Number
Indicates the manufacturer's serial number.
Manufacturer Name and Address
Indicates the name and address for the manufacturer of
this device.
Date of Manufacture (Year)
Indicates the original manufacture date for this device.
Consult Instructions for Use
Consult the operating instructions.
Type CF Applied Part
Identifies a type CF applied part on medical equipment
that complies with IEC 60601–1.
This device meets the requirements for protection against
electric shock for an earth-free (floating) applied part (one
intended for contact with patients) for cardiac application.
IP43
IP Code (Ingress Protection Rating)
Classifies and rates the degree of protection provided
against the intrusion of solid objects (such as body parts
like hands and fingers, dust, accidental contact), and fluids.
The first numeral (4) represents the degree of protection
against the ingress of solid objects. In this case, objects
> 1 mm (0.04 inches).
The second numeral (3) represents the degree of protec-
tion against the ingress of liquids. In this case, protected
against spraying water.
NOTICE
INGRESS PROTECTION RESTRICTED TO THE FOLLOW-
ING CONDITIONS –IP43 applies only when the bat-
tery door is closed and latched AND if the ECG cable
is properly connected to the recorder.
Before starting a recording, make sure that the bat-
tery door is closed and latched AND that the ECG ca-
ble is properly connected to the recorder.