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GE Healthcare

SEER™ 1000
ECG Recorder and Mobile Application
Operating Manual
Version 1.0
2067634-077 Revision F

SEER™ 1000 ECG Recorder and Mobile Application


English
© 2018 General Electric Company
All Rights Reserved
Publication Information
The information in this manual applies only to the SEER™ 1000 ECG Recorder and Mobile Application. Due to continu-
ing product innovation, specifications in this manual are subject to change without notice.

This manual is developed and owned by GETEMED Medizin- und Informationstechnik AG (GETEMED), 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.

iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. “Made for iPod,”
“Made for iPhone,” or “Made for iPad”, on the product packaging, indicates that an electronic accessory has been de-
signed to connect specifically to the iPod, iPhone, or iPad, and has been certified by the developer to meet Apple per-
formance standards. Apple is not responsible for the operation of this device or its compliance with safety and regula-
tory standards. 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 United States
and/or other countries.

The CE mark indicates that the product complies with medical device regulations of the European Union and other
jurisdictions recognizing this mark:

Revision History
The document part number and revision display 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”

C 26 May 2015 EAC

D 03 November 2015 “Connecting the ECG Cable to the Recorder and to the Electrodes”,
page 48
"Recorder Data Protection”, page 59
“Using the Apple iOS App”, page 63

E 13 June 2016 “Software Identification”, page 30


“Connecting the ECG Cable to the Recorder and to the Electrodes”,
page 48
“Mechanical”, page 116

2 SEER™ 1000 2067634-077 Revision F


28 May 2018
Revision Publication Date Description

F 28 May 2018 Included information per IEC 60601-1-2: 2015


Included information per IEC 60601-1-11: 2015
Updated symbols (GOST and pressure), page 21
Updated device and packaging labels, page 27
Updated cleaning instructions page 109
Updated iOS App workflow page 63

Contact your local GE Healthcare representative for related product manuals

2067634-077 Revision F SEER™ 1000 3


28 May 2018
4 SEER™ 1000 2067634-077 Revision F
Contents

1 Introduction ......................................................................................................... 11
Intended User .................................................................................................................................12
Indications for Use .......................................................................................................................12
Intended Use ...................................................................................................................................12
Contraindications .........................................................................................................................12
Prescription Device Statement ..............................................................................................12
Regulatory and Safety Information ....................................................................................12
Safety Conventions.......................................................................................................13
Safety Hazards................................................................................................................13
Medical Device Classification ..................................................................................19
Certification ......................................................................................................................19
Input Signal Reproduction Accuracy ..................................................................19
EMI/EMC/RF Caution ....................................................................................................20
Biocompatibility ..............................................................................................................21
Supply and Accessory Information ......................................................................21
Manufacturer Responsibility ....................................................................................21
Product and Package Information .......................................................................21
Equipment Identification ..........................................................................................................28
Product Label...................................................................................................................28
Serial Number Format and Product Code ........................................................29
Software Identification ...............................................................................................30
Service Information .....................................................................................................................31
Service Requirements .................................................................................................31
Warranty Information .................................................................................................31
Additional Assistance ..................................................................................................31
Manual Information ....................................................................................................................31
Manual Purpose .............................................................................................................32
Document Conventions .............................................................................................32
Related Documents ......................................................................................................33

2067634-077 Revision F SEER™ 1000 5


2 Product Overview ............................................................................................... 35
Recorder and Application – General ..................................................................................35
Operating Elements of the Recorder .................................................................................36
Event Button .....................................................................................................................37
Event Button LED ...........................................................................................................38
Hookup Guidance LED ................................................................................................38
Audible Notifications ....................................................................................................39
3 Preparing the Recording ................................................................................... 41
Instructing the Patient ...............................................................................................................42
Safety Precautions ........................................................................................................42
Recording Diary ..............................................................................................................42
Marking a Patient Event .............................................................................................43
Preparing the Patient's Skin ....................................................................................................43
Placing the Electrodes ...............................................................................................................44
Electrode Placement with 7 Leads for 3-Channel Recordings.............45
Electrode Placement with 5 Leads for 2-Channel Recordings.............46
Electrode Placement with 3 Leads for the Recording of 3 Non-
Independent ECG Channels .....................................................................................47
Connecting the ECG Cable to the Recorder and to the Electrodes ....................48
Inserting a Battery .......................................................................................................................49
Reattaching or Replacing the Battery Compartment Door ...................................50
Switching on the Recorder ......................................................................................................51
Starting the Recording ...............................................................................................................51
Auto-Start ..........................................................................................................................52
Auto-Switch-off ..............................................................................................................53
4 After Completing the Recording ...................................................................... 55
Switching Off Before the Recording Duration Has Been Reached ....................55
Removing the Electrodes .........................................................................................................56
Transferring the ECG Data to a PC ......................................................................................56
Compatible Evaluation Software ..........................................................................56

6 SEER™ 1000 2067634-077 Revision F


5 Applications (Apps) – General Information .................................................... 57
Functionality....................................................................................................................................58
Data Protection .............................................................................................................................59
App Data Protection.....................................................................................................59
Recorder Data Protection .........................................................................................59
Basic Information on Wireless Bluetooth Connection ..............................................60
6 Using the Apple iOS App .................................................................................... 63
Installing and Setting up the App .........................................................................................63
Installing and Starting the App...............................................................................63
Changing the Administrator Password..............................................................64
Add Technician or Reset Technician Password .............................................65
Configuring the MUSE Orders connection .......................................................68
Reset Application ...........................................................................................................70
Starting the App and Changing the Technician Password ....................................70
Remember My ID ..........................................................................................................................71
Patients Tab – Preparing and Starting an ECG Recording......................................72
Add Patient .......................................................................................................................72
Editing or Deleting a Patient Entry .......................................................................75
Find Device........................................................................................................................76
Electrode Placement and Waveform Preview ...............................................78
Verify or Change Settings .........................................................................................79
Start the Recording ......................................................................................................80
Devices Tab .....................................................................................................................................81
7 Using the Microsoft Windows App .................................................................. 83
Installing and Setting up the App .........................................................................................83
Hardware Specifications ...........................................................................................83
Using the Bluetooth Adapter ...................................................................................84
Installing and Starting the PC App........................................................................84
Removing the PC App ..................................................................................................84
Changing the Administrator Password..............................................................85
Add Technician or Reset Technician Password .............................................86
Reset Application ...........................................................................................................87
Starting the App and Changing the Technician Password ....................................88

2067634-077 Revision F SEER™ 1000 7


Patient Hookup ..............................................................................................................................90
Add or Select a Patient, Connect to the Recorder........................................90
Electrode Placement and Waveform Preview ...............................................92
Verify or Change Settings .........................................................................................93
Start the Recording ......................................................................................................94
Patients Tab .....................................................................................................................................95
Devices Tab .....................................................................................................................................96
8 Troubleshooting.................................................................................................. 97
Recorder Troubleshooting .......................................................................................................97
Application Troubleshooting ..................................................................................................99
Bluetooth Troubleshooting ................................................................................................... 103
MUSE Orders Troubleshooting ........................................................................................... 104
Bluetooth Messages from the Microsoft Windows System ............................... 105
Resetting the recorder with the iOS App ....................................................................... 105
Resetting the Recorder with the Microsoft Windows App ................................... 107
How to Notify Service if the Recorder is Defective .................................................. 108
9 Maintenance ......................................................................................................109
Cleaning and Disinfection ..................................................................................................... 109
Cleaning and Disinfecting the Recorder ....................................................................... 111
Cleaning the Carrying Pouch .............................................................................................. 111
Cleaning, Disinfecting, and Storing ECG Cables ........................................................ 111
Storing ECG Cables .................................................................................................... 113
Cleaning the Battery Contacts ........................................................................................... 114
Checking ECG Cable and Connectors ............................................................................. 114
A Specifications ....................................................................................................115
General............................................................................................................................................ 115
Electrical ......................................................................................................................................... 116
Mechanical.................................................................................................................................... 116

8 SEER™ 1000 2067634-077 Revision F


Environmental ............................................................................................................................. 117
Bluetooth module ...................................................................................................................... 117
EMC Specifications according to IEC 60601-1-2 ...................................................... 118
General Specifications ............................................................................................. 118
Electromagnetic immunity (line-bound disturbances) ........................... 119
Electromagnetic immunity (conducted and radiated
RF disturbances) .......................................................................................................... 120
B Index....................................................................................................................121

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1
1 Introduction

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 configure the recorder with the patient demographic data, visu-
ally inspect the ECG waveforms, change recorder settings, and start the
recording. 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.

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Introduction

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. Both
the SEER 1000 recorder and the Mobile Application are medical devices.
As such, they were designed and manufactured to the appropriate medi-
cal regulations and controls.

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Introduction

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.

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Introduction

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.
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.

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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.
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:
o Use protective gloves to handle the equipment.
o Isolate the material by using suitable packaging and labeling.
o Contact the addressee before sending the equipment.
o Clean the recorder and accessories after every use. For infor-
mation, refer to the chapter “Maintenance” on page 109.
WARNING
RISK OF CHOKING – Packaging material can pose a choking hazard.
Keep packaging material out of children's reach.
WARNING
MAINTENANCE - As long as the device is connected to the patient, no
maintenance or cleaning tasks may be performed.
Remove the device from the patient before carrying out such tasks.

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Introduction

WARNING
EXTREME TEMPERATURES – Device performance may be compromised
at extreme temperatures.
If the device has been stored at a temperature close to the extreme hot
or cold limits, wait at least 4 hours for the device to reach ambient tem-
perature before use.
WARNING
HOUSEHOLD PETS AND VERMIN – Household pets and vermin may
pose a risk to patient safety.
Protect the equipment against contact with household pets and
pests, as they could cause safety related damage to it, e.g., by biting
it, letting it drop, exposing it to fluids or dirt.

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.

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. For additional information, refer to “Connect-
ing the ECG Cable to the Recorder and to the Electrodes” on page 48.

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Introduction

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 41.
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.
If external visible dampness is observed, dry the device and wait at
least two hours with the battery door open before reuse.
NOTICE
DAMAGE TO THE DEVICE – There are no serviceable parts inside the
recorder housing. Do not attempt to disassemble the recorder.
Do not use force when handling the recorder.
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.

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Introduction

Observe the information contained in the “Maintenance” chapter on


page 109.
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.
Contact your service representative for inspection if you find or even
suspect a malfunction. Please include 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.
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 physician to provide the patient with the
information required for the ECG recording. See “Instructing the Pa-
tient” on page 42 for more information.
18 SEER™ 1000 2067634-077 Revision F
Introduction

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 EN IEC 60601-1:

Medical Device Classification


Category Classification

Degree of protection against elec- Type CF non-defibrillation-proof ap-


trical shocks plied part.
Degree of protection against harm- The ingress protection classification of
ful ingress or water the recorder is IP43, whereby
4 = Protection against objects > 1 mm
(0.04 inches)
3 = Protection against spraying water
Degree of safety of application in Equipment is not suitable for use in the
the presence of a flammable anes- presence of a flammable anesthetic
thetic mixture with air or with oxy- mixture with air or with oxygen or with
gen or with nitrous oxide nitrous oxide.
Method(s) of sterilization recom- Not applicable
mended by the manufacturer
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 EN IEC 60601-2-47 require-
ments:

2067634-077 Revision F SEER™ 1000 19


Introduction

 The response of the recorder to a 5 mV 100 ms rectangular pulse


does not show a baseline amplitude displacement 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.
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
frequency (RF) emitting equipment near the system may cause unex-
pected or adverse operation.
Do not use portable phones or other electronic equipment that may
emit radio frequency (RF) near this system.
WARNING
ACCESSORIES/COMPONENTS — Use of accessories other than those
recommended in the accompanying Supplies and Accessories Refer-
ence Manual, or modifying the medical device or system, may result
in increased EMISSIONS or decreased IMMUNITY of the device or sys-
tem.

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Introduction

Use the following resources for more information on EMI/EMC and RF


concerns:
o The Supplies and Accessories Reference Manual for your system
o GE Healthcare or GE Healthcare authorized representatives
o 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.

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 equipment is used in accordance with the instructions for use.

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

2067634-077 Revision F SEER™ 1000 21


Introduction

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.

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.

Type CF Applied Part


Identifies a type CF applied part on medical equipment that
complies with EN IEC 60601–1.
This device meets the requirements for protection against elec-
tric shock for an earth-free (floating) applied part (one intended
for contact with patients) for cardiac application.

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Symbol Description

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 protection
against the ingress of liquids. In this case, protected against
spraying water.
NOTICE
INGRESS PROTECTION RESTRICTED TO THE FOLLOWING
CONDITIONS – IP43 applies only when the battery door is
closed and latched AND if the ECG cable is properly con-
nected to the recorder.
Before starting a recording, make sure that the battery
door is closed and latched AND that the ECG cable is
properly connected to the recorder.
CAUTION
CONSULT ACCOMPANYING DOCUMENTS – There may be
specific warnings or precautions associated with the de-
vice that are not otherwise found on the label.
Consult the accompanying documentation for more infor-
mation about safely using this device.
Non-ionizing Electromagnetic Radiation
Indicates that the equipment emits elevated, potentially hazard-
ous, levels of non-ionizing radiation (electromagnetic energy) for
diagnosis or treatment.
Follow Instructions for Use
Read and understand the operator's manual before using the
device or product.
As a mandatory action sign, this symbol is identified by a blue
background and white symbol.
Battery Type
This symbol indicates the type of batteries that may be used
with the device, namely either an alkaline LR03 1.5V battery or a
rechargeable HR03 1.2V battery.

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Introduction

Symbol Description

+
Battery Polarity
This symbol indicates the position of the positive pole of the bat-
tery when inserting it into the device.
Temperature Limits
Indicates the upper and lower temperature limitations for the
transportation and handling of this package.

Capable of Being Recycled


Indicates you may recycle this material or device. Recycle or dis-
pose of in accordance with local, state, or country laws.
Waste of Electrical and Electronic Equipment (WEEE)
Indicates this equipment contains electrical or electronic com-
ponents that must not be disposed of as unsorted municipal
waste, but collected separately. Contact an authorized repre-
sentative of the manufacturer for information concerning the
decommissioning of your equipment.

Rx Only Rx Only
US Federal law restricts this device to sale by or on the order of
a physician.
Environment Friendly Use Period (EFUP)
Per Chinese standard SJ/T11363–2006, indicates the number of
years from the manufacturing date during which you can use
the product before any restricted substances are likely to leak,
causing a possible environmental or health hazard.
NOTE:
If the device contains less than the maximum concentra-
tion of restricted substances, the symbol contains a lower-
case e.
This is also referred to as the China RoHS.
Fragile
Indicates the contents are fragile. Handle with care.

This Way Up
Indicates the correct upright position of the package.

24 SEER™ 1000 2067634-077 Revision F


Introduction

Symbol Description

Maximum Stack Size


Indicates that you should not stack more than 5 containers and
that you should not place a load on the top container.
Keep Dry
Indicates that you need to keep the container away from rain
and other sources of moisture.

Humidity Limits
Indicates upper and lower humidity limits. They are indicated
next to the upper and lower horizontal lines.

Pressure Limits
Indicates the upper and lower air pressure limitations for the
transportation and handling of this package. The limits are indi-
cated next to upper and lower horizontal line.
CE Mark
The CE Mark and Notified Body Registration Number signifies
the device has met all essential requirements of European Medi-
cal Device Directive 93/42/EEC.
PCT (GOST-R) Mark
Indicates the device or product conforms with applicable Rus-
sian Gost standard technical and safety standards.
Eurasian Conformity mark. Conformity to applicable technical
regulations of Customs Union.

FCC Approval (US only)


Indicates the device or product complies with FCC Rule Part 18
Subpart B (18.203) – General information regarding applications
and authorizations for industrial, scientific, and medical (ISM)
equipment.
TÜV Rheinland
Indicates the device or product complies with applicable tech-
nical and safety requirements following testing by Technischer
Überwachungsverein, (Technical Inspections Organization).

2067634-077 Revision F SEER™ 1000 25


Introduction

Symbol Description

Alkaline Battery
This symbol is selected in the applications if an alkaline battery
is used.
Rechargeable battery
This symbol is selected in the applications if a rechargeable
NiMH battery is used.
Battery Level
This symbol displays the battery state in the applications.
Start Recording
This symbol is used in the Apple iOS app to start the recording.
Start Recording
 This symbol is used in the Microsoft Windows app to start the
recording.
Stop Recording
This symbol is used in the Apple iOS app to stop the recording.
Stop Recording
 This symbol is used in the Microsoft Windows app to stop the re-
cording.
Female
This symbol is selected in the apps for female patients.
Male
This symbol is selected in the apps for male patients.

Delete
 This symbol is selected in the apps to delete a patient or techni-
cian.
Next
 This symbol is selected in the Microsoft Windows app to call up
the next step.
Edit
 This symbol is selected in the Microsoft Windows app to edit pa-
tients or technicians.

26 SEER™ 1000 2067634-077 Revision F


Introduction

Symbol Description

Find
 This symbol is selected in the Microsoft Windows app to find a
recorder for wireless connection.
Event Button

 Pressing the button on the recorder starts the recording and,


when the device is already running, marks a cardiac event.

Label Locations
This section identifies the labels and their locations on the product and
packaging. See the “Symbols” section on page 21 for detailed descrip-
tions.
Item Label Location Description

1 Back of See section “Product


device Label” on page 28.

2 Product Identifies the following


Package information for ship-
ping:
 Product
description
 Serial number
 Regulatory
compliance
Manufacturer and dis-
tributor information

2067634-077 Revision F SEER™ 1000 27


Introduction

Item Label Location Description

3 Product Contains handling,


Package cautionary information,
and disposal symbols.

Equipment Identification
GE Healthcare and GE Healthcare distributed devices have a product la-
bel that identifies the product name, part number, manufacturing infor-
mation, and unique serial number. This information is required when con-
tacting GE Healthcare for support.

Product Label
The product label is laid out in the following format. Depending on the
product, the label may vary slightly in format, but it contains the same in-
formation.
For explanations of the symbols, see the “Symbols” section on page 21.

Item Description

SEER 1000 Model


24 Hour Recording duration
Distributed by GE Medical Systems Information Technologies, Inc.

28 SEER™ 1000 2067634-077 Revision F


Introduction

Item Description

UDI Barcode Unique Device Identification is a unique marking


for identification of the medical device. Bar code
containing the serial number (SN), model refer-
ence number (REF), global trade item number
(GTIN), and the date of production.
FCC ID Federal Communications Commission approval ID
of the Bluetooth module

Serial Number Format and Product Code


Each device has a serial number that uniquely identifies the device and
provides important information about the device.
The serial number format is shown in the following illustration:

Item Name Description

1 Product Code A three-digit code that uniquely identi-


fies the product line.
2 Year Manufactured A two-digit code identifying the year the
device was manufactured. Values range
from 00 to 99. For example: 13 = 2013.
3 Product Sequence A five-digit number identifying the order
in which this device was manufactured. Val-
ues for production range from 00101 to
99999.

2067634-077 Revision F SEER™ 1000 29


Introduction

Software Identification
The Unique Device Identification (UDI) number, the software version, a
copyright statement, and the manufacturer information are provided in
the Apple iOS app and Personal Computer app.
To access the information in the iOS app, open the device settings for the
SEER 1000 App on your Apple device as shown in the following graphic.

To access the UDI information on the PC App, move your mouse pointer
over the GE logo in the upper left of the screen as shown in the following
graphic.

30 SEER™ 1000 2067634-077 Revision F


Introduction

Service Information
This section provides information pertaining to the maintenance and ser-
vicing of the system. Familiarize yourself with this information before re-
questing service from GE Healthcare or its authorized representatives.

Service Requirements
Failure on the part of the responsible individual, hospital, or institution us-
ing this equipment to implement a satisfactory maintenance schedule
may cause undue equipment failure and safety hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the
components of this system are always functional when required.
It is the user’s responsibility to report the need for service to
GE Healthcare or to one of their authorized agents.
If properly maintained, the expected service life of the device is seven
years; the expected service life of ECG cables is one year.

Warranty Information
This device is distributed by GE Healthcare. Only authorized GE Healthcare
service personnel should service the device. Any unauthorized attempt to
repair equipment under warranty voids that warranty.

Additional Assistance
GE Healthcare maintains a trained staff of application and technical ex-
perts to answer questions and respond to issues and problems that may
arise during the installation, maintenance, and use of this system.
Contact your local GE Healthcare representative to request additional as-
sistance.

Manual Information
This section provides information for the correct use of this manual.
You should periodically review it and request training assistance from GE
Healthcare, if needed.

2067634-077 Revision F SEER™ 1000 31


Introduction

Manual Purpose
This manual provides information necessary for the configuration and
safe operation of this equipment in accordance with its function and in-
tended use. It is not intended as a replacement for, but a supplement to,
thorough product training. Additional manuals will be provided electroni-
cally upon request.

Document Conventions
This document uses the following conventions.

Typographical Conventions
The following table identifies the typographical conventions used in this
document, other GE Healthcare Diagnostic Cardiology product docu-
ments, and third-party product documents distributed by GE Healthcare
Diagnostic Cardiology.
Convention Description

Bold Text Indicates keys on the keyboard, text to enter, or hard-


ware items such as buttons or switches on the equip-
ment
Italicized Bold Text Indicates software terms that identify menu items,
buttons, or options in various windows.
KEY1+KEY2 Indicates a keyboard operation. A plus (+) sign be-
tween the names of two keys indicates that while
holding the first key, you should press and release the
second key. For example, Press CTRL+ESC means to
press and hold the CTRL key and then press and re-
lease the ESC key.
Enter Indicates that you must press the Enter or Return key
on the keyboard. Do not type Enter.
<space> Indicates that you must press the spacebar. When in-
structions are given for typing a precise text string
with one or more spaces, the point where you must
press the spacebar is indicated as: <space>. This en-
sures that the correct number of spaces is inserted in
the correct positions within the literal text string. The
purpose of the < > brackets is to distinguish the com-
mand from the literal text within the string.

32 SEER™ 1000 2067634-077 Revision F


Introduction

Convention Description

> The greater than symbol, or right angle bracket, is a con-


cise method to indicate a sequence of menu selections.
For example, the statement “From the main menu, se-
lect System > Setup > Options to open the Option Ac-
tivation window” replaces the following:
1. From the main menu, select System to open
the System menu.
2. From the System menu, select Setup to open
the Setup menu.
3. From the Setup menu, select Options to
open the Option Activation window.

Illustrations
All illustrations in the document are provided as examples only. Depend-
ing on system configuration, screens that appear in the document may
differ from the screens as they appear on your system.

Notes
Notes provide tips or additional information that, while useful, are not es-
sential to the correct operation of the tools. They are called out from the
body text through a flag word and indentation:

Related Documents
The following documents are referenced in this manual and provide addi-
tional information that may be helpful in the configuration, the mainte-
nance, and the use of this product.
Part Number Title

2067634-078 SEER 1000 Supplies and Accessories Reference Manual


2067634-079 SEER 1000 Quick Start Guide

2067634-077 Revision F SEER™ 1000 33


2
2 Product Overview

This chapter describes the main features of the recorder. You will be pre-
sented more specific information and graphics in the following sections.

Recorder and Application – General


Three models of the SEER 1000 recorder are available:
 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 devices are capable of performing a 2- or 3-channel Holter ECG re-


cording. The number of channels recorded depends solely on the type of
ECG cable used.
The devices automatically detect pacemaker pulses as a standard fea-
ture. No user settings are required for pacemaker detection.
The recorders may be used together with an external application (app)
that allows wireless data exchange with the device. Two apps are availa-
ble: one that runs on an Apple iPad, iPod, or iPhone, and one that operates
on a standard PC with a Microsoft Windows operating system. Either app
can be used during the patient hookup phase to configure the recorder
with patient demographic data, visually inspect the ECG waveforms,
change recorder settings, and start the recording. The SEER 1000 record-
ers may be used as stand-alone devices without the apps.

2067634-077 Revision F SEER™ 1000 35


Product Overview

ECG recordings are transferred to the evaluation workstation using a spe-


cial USB cable.

Operating Elements of the Recorder

1. Event Button
2. Event Button LED
3. Combined ECG Cable Connector and USB Cable Connector
4. Hookup Guidance LED
5. Battery Compartment
6. Battery Compartment Latch

36 SEER™ 1000 2067634-077 Revision F


Product Overview

Event Button

This button is used to perform the following functions:


Function User Action

Switch on/off the re- Press and hold for more than a second until a
corder beep sounds.
NOTE:
Once it has started recording, the recorder
cannot be turned off unless the battery is
removed. During recording, pressing and
holding the Event Button will activate the
wireless connectivity.
Start a recording with- Press and release. A double beep will sound to
out the app confirm the recording has started.
Mark an event during Press and release. A beep will sound to confirm
recording the event has been recorded.
Activate wireless con- Press and hold for more than three seconds until
nectivity a multi-beep sounds.
NOTE
Wireless connectivity will be active prior to
starting a recording. To activate wireless
connectivity after the recording has started,
press and hold the Event Button.

2067634-077 Revision F SEER™ 1000 37


Product Overview

Event Button LED

This two-color LED indicates the following recorder statuses:


Recorder Status Status Indicator Light

Ready for recording Solid green


Recording in process Intermittent flashing green
Event marked (by pressing Event Green, then fades
Button)
Contains recording Solid yellow
Low battery Slow flashing yellow
Service needed Fast flashing, green and yellow al-
(Refer to “How to Notify Service if ternating
the Recorder is Defective” on page
104 for additional information.)

Hookup Guidance LED

Prior to recording, this two-color LED indicates the following hookup sta-
tuses:
Hookup Status Hookup Guidance Light

Electrodes properly connected Solid green

Electrodes loose or disconnected Flashing yellow


(excluding ground electrode)
If the 3-Lead cable is used, the open
lead detection of the SEER 1000 re-
corder is disabled.
Recording in process LED is turned off

38 SEER™ 1000 2067634-077 Revision F


Product Overview

Service needed Fast flashing, green and yellow al-


(Refer to “How to Notify Service if ternating
the Recorder is Defective” on page
104 for additional information.)

NOTE
After the recorder is switched on, both LEDs illuminate green and
then yellow for 0.5 seconds to inform the user that they are working
properly.

Audible Notifications
The SEER 1000 provides the following audible feedback:
Status Buzzer Notification

Recorder is turned on Short single beep


Recording has started Double beep
Recording cannot start Three low beeps
(e.g. due to weak battery or ECG cable has not
been connected)

Event marked (by pressing Event Button) Single beep


Wireless connectivity is activated Multi-beep

Recorder is switched off Single beep

2067634-077 Revision F SEER™ 1000 39


3
3 Preparing the Recording

This chapter provides information on instructing the patient as well as on


the procedures for preparing the patient's skin, for properly placing elec-
trodes, and for starting the recording without using the app.
NOTE
You can find information on using the app for starting the recording
in the sections “Using the Apple iOS App” on page 63 and “Using the
Microsoft Windows App” on page 83.
After step 6, you can proceed using the respective app for entering
patient demographic data and for checking the signal quality.
We recommend the following steps to prepare the recording. Each step is
described in detail in the following sections.
1. Instruct the patient about the required safety precautions, the re-
cording diary, and marking an event.
2. Prepare the patient’s skin.
3. Attach the electrodes to the patient.
4. Connect the ECG cable to the recorder and to the electrodes.
5. Insert a fresh battery into the recorder.
6. Switch on the recorder.
Ensure that the Event Button LED is green.
Ensure that the Hookup Guidance LED is green.

7. Start the recording.

2067634-077 Revision F SEER™ 1000 41


Preparing the Recording

Instructing the Patient


It is the responsibility of the medical doctor to provide the patient with the
following information required for a safe and effective ECG recording.

Safety Precautions
 Notify the doctor if skin problems develop.
In rare cases, even when using biocompatible electrodes, allergic re-
actions may occur.

 Do not expose the recorder to water, including adverse weather con-


ditions or by taking a bath or shower.
 Keep the recorder inside its pouch and wear it under a coat during
adverse weather. Excessive humidity can damage parts of the device.
 Do not expose the device to extreme temperatures.
The temperature of the recorder must not go below 5°C (41°F) or
above 45°C (113°F). In hot climates, stay in temperature-controlled
environments as much as possible. In cold climates, wear the re-
corder under outer garments.

 Do not expose the device to sudden temperature or humidity changes.


Quick changes in temperature or humidity can cause condensation.
Do not bring the recorder into the proximity of heat sources, such as
heaters and ovens, and do not expose it to direct sunlight.

 Do not excessively bend or wrap the ECG cable around the recorder.
The ECG cable can be damaged in this way.
 Keep a distance from electrical equipment.
 Do not use an electric blanket when you are wearing the recorder.

Recording Diary
We also recommend having the patient maintain a diary to record activi-
ties, symptoms, and the corresponding times during the ECG recording.
The header of this diary should include patient demographic data, re-
corder identification, and medication taken.

42 SEER™ 1000 2067634-077 Revision F


Preparing the Recording

At a minimum, the patient should enter the following information into the
diary:
 activities and state of health every two hours,
 whenever you have pressed the Event Button,
 any pain, feelings of illness, sensations of numbness, dizziness, palpi-
tations,
 each visit to the toilet,
 medication dosage,
 any strenuous activity such as running, carrying heavy items, shop-
ping, or cycling, and
 preferred or dominant sleeping position (i.e., on the left side, right side,
back, or front).

Marking a Patient Event


Instruct the patient to press the Event Button briefly during a recording to
mark an event. A short beep informs the patient that the event has been
marked. A second marker can be used to indicate the end of an event.
The physician can use the patient event to specifically evaluate ECG seg-
ments for certain times or conditions.

Preparing the Patient's Skin


Careful skin preparation is the key to an interference-free ECG.
1. Select the electrode placement sites for ECG diagnosis per the
protocol specified by the hospital or physician.
Refer to “Placing the Electrodes” on page 44 for diagrams and
descriptions of electrode placement.

2. Ensure that each site is dry, clean, and free of excessive hair.

NOTE:
Use a lint free cloth to dry the skin. Solvents trapped under
electrodes may lead to abnormal skin reactions.

3. Apply electrodes to the prepared sites.


2067634-077 Revision F SEER™ 1000 43
Preparing the Recording

4. Look at the Hookup Guidance LED for indication of lead problems.


NOTE:
Use only electrodes and contact agents recommended by
GE Healthcare.

Placing the Electrodes


This section describes the placement of the electrodes for 2-channel and
3-channel Holter ECG.
CAUTION
PROPER LEAD WIRE CONNECTION — Improper connection will cause
inaccuracies in the ECG.
Use stress loops to reduce the movement of the electrodes caused by
tension from the leadwires.
Secure the electrodes with tape to prevent movement and maintain
electrical contact.
Apply the tape loosely enough so that no gel squeezes onto the adhe-
sive surfaces of the electrodes.

44 SEER™ 1000 2067634-077 Revision F


Preparing the Recording

Electrode Placement with 7 Leads for 3-Channel


Recordings
To record a 3-channel ECG, seven electrodes are attached and connected
to the color-coded leads.

AHA Color Coding IEC Color Coding

AHA Color IEC Color Channel Location

Red Green CH 1 (+) Left anterior axillary line, 5th rib


White Red CH 1 (–) Right manubrial border of sternum
Brown White CH 2 (+) Right border of sternum, 4th rib
Black Yellow CH 2 (–) Left manubrial border of sternum
Orange Orange CH 3 (+) Left border of sternum, 4th intercostal space
Blue Blue CH 3 (–) Center of upper sternum
Green Black Ground Lower right rib margin over bone

2067634-077 Revision F SEER™ 1000 45


Preparing the Recording

Electrode Placement with 5 Leads for 2-Channel


Recordings
To record a 2-channel ECG, five electrodes are attached and connected to
the color-coded leads.

AHA Color Coding IEC Color Coding

AHA Color IEC Color Channel Location

Red Green CH 1(+) Left anterior axillary line, 5th rib


White Red CH 1 (–) Right manubrial border of sternum
Brown White CH 2 (+) Right border of sternum, 4th rib
Black Yellow CH 2 (–) Left manubrial border of sternum
Green Black Ground Lower right rib margin over bone

46 SEER™ 1000 2067634-077 Revision F


Preparing the Recording

Electrode Placement with 3 Leads for the Recording of


3 Non-Independent ECG Channels
To record 3 non-independent ECG channels, three electrodes are at-
tached and connected to the color-coded leads.

AHA Color Coding IEC Color Coding

AHA Color IEC Color Location

White Red Right manubrial border of sternum


Black Yellow Right border of sternum, 7th rib
Red Green Left lower rib cage

2067634-077 Revision F SEER™ 1000 47


Preparing the Recording

Connecting the ECG Cable to the Recorder and to the


Electrodes
Connect the ECG cable to the recorder and to the electrodes.
CAUTION
CABLE DAMAGE – Damaged ECG cables are the most frequent causes
of bad or insufficient recordings.
Check the cable before connecting the electrodes.
NOTICE
CONNECTOR AND RECORDER DAMAGE – The patient leadwire can be
connected to the recorder in one orientation only. Improperly con-
necting the cable can severely damage the device. Damage resulting
from improper use is not covered by the warranty.

For correct orientation, align the marks on the connector and the re-
corder as shown by a green circle in the graphic. Do not try to con-
nect the cable any other way.
Never twist the cable connector at an angle to the front or back of
the recorder, as shown by the red arrows in the right-hand picture of
the graphic.
Never use force to plug the ECG cable into the recorder, and do not
excessively bend the ECG cable or wrap it around the device.
Disconnection of the cable should be performed by pulling the con-
nector straight off the recorder. Do not disconnect by pulling on the
cable.

48 SEER™ 1000 2067634-077 Revision F


Preparing the Recording

Inserting a Battery
NOTICE
RECORDING DURATION MAY NOT BE REACHED – In order to achieve
the full 7 day recording duration, a new or fully charged high quality
battery is required. Low quality batteries or a rechargeable battery
which is not fully charged or aged may not last 7 days.
Before every recording, the Event Button LED must be green. If it
flashes yellow once every second, a new battery is necessary.
NOTICE
NO BATTERY CHARGER – The recorder is not capable of charging a re-
chargeable battery.
Use a rechargeable battery only if it is fully charged.
Slide back the Battery Compartment Latch.
Insert the battery as illustrated below with the negative end facing up.

To avoid that a recording ends before the recording duration set has been
reached:
 inspect the cable contacts for damaged pins,
 inspect the battery contacts for corrosion or other damage,
 inspect the recorder housing for cracks or openings,

2067634-077 Revision F SEER™ 1000 49


Preparing the Recording

If any such thing is found, do NOT use the recorder service, but rather
contact GE Service to arrange for repairs.

Reattaching or Replacing the Battery Compartment


Door
To open the Battery Compartment Door, slide back the Latch as shown
in the previous section.
If you further open the Battery Compartment Door, it will detach from
the recorder housing.
To reattach or to replace the Battery Compartment Door, hold the door
as shown in the left graphic below and push it into its bearings.
NOTICE
RECORDER DAMAGE – The Battery Compartment Door can be at-
tached to the recorder housing in one orientation only.
Attach the Battery Compartment Door as shown in the left graphic
below. Do not try to attach the Battery Compartment Door any other
way.

NOTICE
The battery door, if damaged, is not covered under warranty. The part
number of a replacement battery door can be found in the Supplies
and Accessories Reference Guide.

50 SEER™ 1000 2067634-077 Revision F


Preparing the Recording

Switching on the Recorder


Press the Event Button in the middle of the recorder casing to switch on
the recorder.
NOTE
If both LED alternatively flash between green and yellow three times per
second, the recorder has a fault and service is needed. Refer to the sec-
tion “How to Notify Service if the Recorder is Defective” on page 108.

Starting the Recording


Press the Event Button in the middle of the recorder to start the record-
ing. The recording will only start if the device does not already contain a
recording, if no low battery condition exists and no open lead faults are
detected.
CAUTION
SIGNAL QUALITY – If there is a severe muscle interference or artifact
on the ECG when you tap the top of the electrodes lightly or when the
patient moves, it is possible that the electrodes are not attached
properly.
Reattach the electrodes properly.
NOTE
If a previous recording is still stored in the recorder, the Event Button
LED will be yellow and the recording will not start. You will need to
erase the recording before continuing. A recording can only be de-
leted using the app or the Holter analysis software.

NOTE
If the 3-Lead cable is used, the open lead detection of the SEER 1000
recorder is disabled. Double check that the cable is properly attached
to the electrodes even if the Hookup Guidance LED is green.

NOTE
If available, you can also start the recording with the app after select-
ing or adding a patient and after checking the signal quality.

2067634-077 Revision F SEER™ 1000 51


Preparing the Recording

See chapter 5, “Applications (Apps) – General Information”, chapter 6,


“Using the Apple iOS Apps”, and chapter 7, “Using the Personal Com-
puter App”, for more information on the apps.

NOTE
The recorder date/time is set during hookup using the Mobile Applica-
tion or CardioDay software. If the recorder is used without any kind of
hookup application, the start date/time of the recording will not be
accurate.

Auto-Start
If the start sequence has not been completed and the recorder detects a
signal from at least one channel, it automatically starts the recording af-
ter eight minutes.
The eight-minute timer is retriggered
 each time wireless communication takes place,
 if the cable status changes (e.g., cable attached or removed), or
 if the Event Button is pressed but no recording starts because of low
battery or open lead (error sound).
NOTE
If the 3-Lead cable is used, the open lead detection of the SEER 1000
recorder is disabled. Double check that the cable is properly attached
to the electrodes even if the Hookup Guidance LED is green.

NOTE
Once the recording has automatically started, it is not possible to ac-
cess the recorder demographic and ECG data using an app until the
recording has been stopped and the data deleted via the MARS or
CardioDay software.

NOTE
While the auto-start function helps ensure the Holter study starts
even if the user forgets to press the Event Button, we recommend
that you manually start each recording. The automatic start function
should only be considered as a backup feature.

52 SEER™ 1000 2067634-077 Revision F


Preparing the Recording

Auto-Switch-off
If the recording has not been started, the recorder will automatically
switch off after eight minutes if no ECG is detected and if no communica-
tion (wireless or via USB) takes place.
The eight-minute timer is retriggered
 each time wireless communication takes place,
 if the cable status changes (e.g., cable attached or removed), or
 if the Event Button is pressed but no recording starts because of low
battery or open lead (error sound).

2067634-077 Revision F SEER™ 1000 53


4
4 After Completing the Recording

The recorder automatically switches off when the recording duration has
been reached.
CAUTION
DATA LOSS – The recorder retains the data for at least one month af-
ter the recording has finished.
Make sure the data is transferred and erased before assigning the re-
corder to another patient.

Switching Off Before the Recording Duration Has Been


Reached
NOTE
The only way to prematurely terminate a recording without using an
app is to open the battery compartment to disconnect or remove the
battery.
If the battery compartment is opened before the recording duration has
been reached, the recording ends at this time but is nevertheless stored
properly.
For terminating a recording using an app, refer to the “Device tab” section
on page 81 (for the Apple iOS app) or page 96 (for the Microsoft Windows
app).

2067634-077 Revision F SEER™ 1000 55


After Completing the Recording

Removing the Electrodes


CAUTION
RISK OF UNNECESSARY SKIN IRRITATIONS – After a long-term ECG ex-
amination, the electrodes may be difficult to remove from the skin.
Slowly peel off the electrodes starting at their outer edge. Pull on the
plastic connectors only; never pull the cable leads to detach the snap
fasteners or plug-in connections from the ECG cable.

Transferring the ECG Data to a PC


NOTE
Do not disconnect the USB cable during data transfer.
NOTE
If you manually switch off the recorder while it is connected to your
computer’s USB port, you must disconnect it from the USB port so
that it can power-down completely.
Use the SEER 1000 USB download cable to connect the recorder to a PC
containing ECG analysis and evaluation software. For correct handling, re-
fer to “Connecting the ECG Cable to the Recorder and to the Electrodes”
on page 48.
As the recorders perform a series of internal tests after being switched on,
you need to wait until the status LED lights up yellow before you can start
transferring data to your evaluation software. This may take up to 10 sec-
onds.
When you connect a recorder to the USB port of your computer, a USB
driver is installed. This process will be repeated if you connect the same
recorder to another USB port on the same computer.
Refer to the manual of the analysis and evaluation software for further in-
formation on transferring the ECG data.

Compatible Evaluation Software


The data stored by the devices are compatible with the GETEMED evalua-
tion software CardioDay 2.4 (and above) and the GE Healthcare MARS
Ambulatory ECG System, V8.0 SP3 (and above).

56 SEER™ 1000 2067634-077 Revision F


5
5 Applications (Apps) – General Information

There are two applications (apps), one which is available as an Apple iOS
app running on an iPod touch, an iPhone, or an iPad, and one which is
available as a standalone software app running on a personal computer
under Microsoft Windows operating systems.
NOTICE
PATIENT PRIVACY – Demographic and medical patient data are sub-
ject to special regulations.
Please note that, in some countries, you must have written consent
from patients or their representatives before entering their data into a
database or viewing their medical data.
NOTICE
SOFTWARE INTRUSION – PCs and software delivered are scanned for
viruses but can, nevertheless, be intruded by software viruses.
We recommend the following:
o Install a good quality virus scanning program and regularly up-
date it.
o Establish procedures to avoid infected software reaching your
computer in the first place, e.g., check the source of any software
you use and use only original software packages.
o Do not install the software onto a computer that is frequently
used for downloading information from the Internet.
o Store patient and recording data regularly using appropriate
storage procedures.

2067634-077 Revision F SEER™ 1000 57


Applications (Apps) – General Information

NOTE
It is not possible to read-out a recording from the recorder using
these apps. Recordings are read-out using the MARS or CardioDay
software packages.

Functionality
Both apps provide the following functionality:
 Initiate a secure wireless connection to a recorder.
 Transfer a patient ID and demographic data to a recorder.
 Transfer a technician ID to a recorder.
 View the recorder’s settings.
 Set the duration of a recording.
 Set the type of battery, i.e., 1.5 V single-use type or 1.2 V rechargeable
type.
 Display the battery status.
 View patient demographic information stored in a recorder.
 View the date and time of the recorder’s internal clock.
 Set the date and time on the recorder’s clock.
 Display cable color codes and ECG waveforms.
 Inform the technician if the battery is too weak to perform a new re-
cording.
 Inform the technician if the previous recording has not been deleted.
 Delete a recording and demographic data from a recorder.
 Set the automatic delete post-download function on the recorder.
 Reset the SEER 1000 recorder.
Communication between the apps and the recorders uses Bluetooth wire-
less technology.

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Applications (Apps) – General Information

Data Protection
For data protection purposes, both apps employ access control using two
levels of password protection. The first level is the administrator pass-
word; the second level is the ECG technician password. Setting these
passwords is explained in the section “Changing the Administrator Pass-
word” on page 64 (for the Apple iOS app) or 84 (for the PC app).

App Data Protection


Only an ECG technician to whom a Technician ID has been assigned can
access the app.
Only the administrator can enter and assign a Technician ID to an ECG
technician.
The ECG technician enters the default password given in this operating
manual and changes it to his or her personal password. After that, only
the administrator can reset the technician’s password.

Recorder Data Protection


Once communication with a recorder has been established using an app,
a protection key, which is automatically generated from the administrator
password, is downloaded to the recorder. After that, the recorder can only
be accessed by the app having the same administrator password.
Access is blocked until the patient demographic and ECG data have been
downloaded by MARS or CardioDay and subsequently deleted from the
recorder. Thus, ECG technicians administrated by the same administrator
have access to each other’s recorders at any time. Persons outside the
control of the administrator will not be able to access these recorders and
will receive the error “The password stored in the recorder does not match
the current administrator password.” when trying to connect to a device
from the app.
NOTE
If the recording was started from another system with a different ad-
ministration account password or manually without an app, the pro-
tection key stored on the recorder will be different from what is con-
figured on the system attempting access.

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NOTE
If the administrator changes his or her password, recorders protected
by the previous administrator password are no longer accessible until
the data has been downloaded and deleted.
NOTE
If the recorder has started automatically or has been manually
started using the Event Button, a protection key is automatically gen-
erated by the recorder. In this case, wireless access is no longer pos-
sible until the data has been downloaded and deleted.
Should a recorder become locked because a technician outside the con-
trol of the administrator has established a connection with a recorder, the
recorder can be reset as explained, depending on the app, in the section
“Resetting the recorder with the iOS App”, page 105, or in the section “Re-
setting the Recorder with the Microsoft Windows App”, page 107.
CardioDay users may also use CardioDay rather than an app to download
patient demographic data to a recorder before starting a recording. If the
CardioDay administrator also has the same password as the app admin-
istrator, then the ECG technicians may use their apps to communicate
with the recorders.

Basic Information on Wireless Bluetooth Connection


NOTICE
NO OPTIMUM PERFORMANCE – If you are using any NON-GE SUP-
PLIED Bluetooth wireless equipment, optimum performance cannot
be assured.
GE highly recommends using the Bluetooth adapter recommended in
this manual. Other Bluetooth adapters may function properly, but have
not been fully verified to operate properly under all conditions.
Bear in mind, EVEN WHEN USING GE SUPPLIED BLUETOOTH WIRELESS
EQUIPMENT that the complete data transfer cannot be guaranteed
under all circumstances when using Bluetooth wireless technology
and that range loss can occur if Bluetooth wireless technology and
other RF devices (e.g., WLAN) are used near each other. Also, other
devices could interfere with the equipment, even if the other devices
comply with CISPR emission requirements.

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NOTICE
The recorder consumes more power if Bluetooth wireless technology
is used. If Bluetooth wireless technology is used extensively, a desired
recording duration may not be possible.
NOTICE
Loss of range can occur if Bluetooth wireless technology and other
RF devices (e.g., WLAN) are used close to each other.
NOTE
Additional Bluetooth information for Windows administrators is found
in the “Using the Bluetooth Adapter” section on page 84.
In case of interruptions with the Bluetooth wireless technology, try one of
the following measures:
 Do not position the devices closer than 50 cm (19.7 inches) to each
other or more than 10 m (10.9 yards) from each other.
 Remove any objects from the line of sight between recorder and ap-
plication device.
 Remove any possible RF interfering devices from the vicinity of re-
corder and application device.
Upon switching on the recorder, the Bluetooth module remains active un-
til the recording is started.
Once the recording is started, the wireless connectivity will be deac-
tivated. It can be reactivated during the recording period by pressing the
Event Button for longer than 3 seconds. Thus, the signal quality can be
checked at any time.

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6
6 Using the Apple iOS App

If the administrator has already prepared the app to be used by ECG tech-
nicians, you may skip to the section “Starting the App and Changing the
Technician Password” on page 70.

Installing and Setting up the App


The SEER 1000 app is supported by several iPad, iPhone, and iPod touch
devices. If the app is available for your mobile device, you will find its de-
scription in the App Store.

Installing and Starting the App


1. Touch the icon to call-up the App Store on your device.
2. Search for SEER 1000 Mobile App.
3. Touch Install.
4. Touch the app icon to start the app.

NOTE
Verify that your iOS device has Bluetooth enabled. On your Apple de-
vice, open Settings, select Bluetooth and verify that it is On.

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Changing the Administrator Password


The app is password protected to avoid unintentional access to a re-
corder. GE recommends you change the passwords on first login. Be sure
to use the same administrator password to connect all supported soft-
ware programs (iOS App, PC App, CardioDay, and CardioRead) to the re-
corder. The password is transferred to the recorder with the patient data
and is used to protect the data from unauthorized access.

NOTICE
UNAUTHORIZED ACCESS TO THE RECORDER – The administrator pass-
word is used to secure the recorder from unauthorized access.
Change the password whenever necessary, e.g., if it has been com-
municated to unauthorized people.
NOTE
Only the app administrator can create Technician IDs and reset
passwords to the default password.
The app always opens to the Login screen.
When the app is started for the first time, you are requested to change
the Default Administrator Password.

1. Enter the default password: 14012013


2. Touch Continue.
3. You are asked to enter an Admin ID and a new Administrator
Password.
Entering an Admin ID is optional. If you chose to use the Admin
ID you can also use the account to log on as a technician and
perform a hookup as well as access the Administrator menu
functions.

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4. Replace the default password by entering and confirming your


new password.
Your new password must be at least eight characters long.

5. Touch Set New Password.


The Technicians screen opens.

Add Technician or Reset Technician Password


Only the app administrator can create Technician IDs and reset pass-
words to the default password.
After the administrator has logged in, the Technicians screen is displayed.

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At the bottom of the screen, three buttons are displayed: Add Technician,
as explained in this section, Admin Password, and Orders Settings.
 For information on changing the Admin Password refer to “Changing
the Administrator Password” on page 64.
For information on Orders Settings refer to “Configuring the MUSE
Orders connection” on page 68.
To create a new Technician ID:
1. Touch Add Technician.

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2. Enter the Technician ID.

3. Touch Save.
4. Touch Logout to return to the Technician Login screen.

The first time the technician logs in, he/she will be required to set
up a new password. The default technician password is
20130114. Then the technician can begin to use the app.

To reset a technician password, the administrator has to perform the fol-


lowing steps:

1. Log in as administrator.

Touch Administration in the upper right corner and enter the ad-
ministrator password.

2. Touch the technician entry.

3. Touch Reset Password.

The password of this technician is reset to the technician default


password 20130114.

4. Touch Save.

5. Touch Logout to return to the Technician Login screen.

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Configuring the MUSE Orders connection


If you work with MUSE orders, you can retrieve those orders using the iOS
App.
To connect the MUSE Order List to the app:
1. Log in as administrator.

Touch Administration in the upper right corner and enter the ad-
ministrator password.

2. Select Orders Settings from the menu bar at the bottom of the
window.

3. Enter the settings for the connection to the MUSE API Orders in-
terface. Please consult with your site MUSE administrator or
GEHC Service personnel for proper configuration settings.

The URL to be entered needs to be the base URL for the REST inter-
face followed by the port number, e.g., http://192.168.0.20:8100
or http://MUSEComputer.domain.com:8100.

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NOTE:
URLs with either HostNames or IP addresses are supported.
The IP PORT number of the API service (default 8100) must be
included as part of URL configuration.

Press Test Connection to test the configured MUSE Orders con-


nection. The test will return MUSE connection successful or
MUSE connection failed.

4. Select whether the status of the examination order in the MUSE


order list should change after the recording has started. The Up-
date Order Status button in the MUSE configuration settings
controls whether the Order status is changed when the Order is
downloaded to a recorder and the recording is started.

If this setting is switched OFF, the Order state will remain OPEN
and will not change when a recording is started from this MUSE
Order. With the Order in an OPEN state, it will remain in the re-
sults of subsequent MUSE Queries. Additional recordings may be
started from this Order in this workflow mode.

If this setting is switched ON when a recording is started from a


MUSE order, the MUSE Order will change from an OPEN state to a
PENDING state. Only MUSE Orders that are flagged in an OPEN
state are included in MUSE Query operations; thus, an Order that
is in the PENDING state will not be displayed during subsequent
MUSE Queries. The MUSE order status must be manually updated
after sending a report to MUSE.

5. The MUSE Orders Timeout setting by default is set to 30 seconds.


This timeout is the configured timeout for the MUSE Open/Holter
orders to be received from the configured MUSE system. This
value can be adjusted for system environments where a large
number of Open/Holter Orders may exist or where network per-
formance is anticipated to be slow.

6. Touch Save to save your settings.

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Reset Application
If the administrator password gets lost, the app can be reset to default
settings.
NOTICE
Reset Application deletes all the data on the app and resets it to fac-
tory defaults.
Resetting the application will:
 Restore the default Administrator Password.
 Delete all technician IDs and passwords.
 Delete all patient information stored in the app.
 Erase recorder pairings.
To reset the application:
1. Touch Reset Application in the Administration screen.

2. Enter the default Administrator Password: 14012013.


3. Touch Login.

Starting the App and Changing the Technician Password


NOTE
Verify that your iOS device has Bluetooth enabled. On your Apple de-
vice, open Settings, select Bluetooth and verify that it is On.
The app is password protected to avoid unintentional access to a re-
corder. On your first login overwrite the default password and replace it
with your new password.

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1. Touch the app icon to open the mobile application.

2. Enter the Technician ID that has been set up for you by your ad-
ministrator. You can also use the Admin ID if this has been en-
tered during the initial set up.

3. Enter the default password: 20130114


4. Touch Login.
5. Replace the default password by entering and confirming your
new password.
Your new password must be at least eight characters long.

Remember My ID
If the Remember My ID option is activated, the app displays the latest
logged-in technician ID in the Technician ID field. With this feature ena-
bled, you only need to enter the password of the respective user. To
change users, clear the existing Technician ID and enter a new one.
To activate the Remember My ID feature, drag the right-hand circle to the
right until the icon turns blue.

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Patients Tab – Preparing and Starting an ECG Recording


If you have prepared the recording as explained in the “Preparing the Re-
cording” section on page 41, you can also start the recording using the
Patients tab of the app.
When logging in, the app opens in the Patients tab showing the patients
list.
To start a recording for an existing patient, select the patient by touching
the entry. Proceed as explained in “Find Device” on page 76.

Add Patient
You can enter patient data manually or—if your application is configured
accordingly—retrieve patient demographic data from MUSE Orders.

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Entering patient data manually

1. To add a new patient, touch Add Patient.

2. Enter the patient demographic data in the Add Patient window.


You have to enter at least the Patient ID.

Having added a patient, you have three options: Continue, Save, or Add
Next Patient.
 Touch the Continue button to proceed as explained in “Find Device”
on page 76.
 Touch the Save button to include this patient in the patient list.
 Touch the Add Next Patient to add another patient.

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Retrieving MUSE Orders Patient Data


If your application is configured to query and retrieve patient demo-
graphic data from MUSE Orders, the Query Orders option is displayed in
the Add Patient window and the MUSE system can be accessed.

Click Query Orders to open the list.

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NOTE:
Only MUSE Orders for Holter test types with an OPEN status are dis-
played. If no orders meet this criteria, the list will be empty.
Select your patient and proceed as explained in “Entering patient data
manually” on page 73.

Editing or Deleting a Patient Entry

NOTE:
Patient entries retrieved from MUSE Orders are not editable so that no
information symbol is shown with the entry.
To edit a patient entry, touch the information symbol on the right of
the entry. The Edit Patient window opens where you enter and save your
edits.

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To delete a patient entry, swipe the selected patient row from right to left.
Then touch the Delete button that is displayed to the right of the entry.

Find Device
After selecting a patient, you will be taken to the Find Device screen.
1. If the recorder is not turned on, press the Event Button until you
hear a beep to switch on the recorder.
2. Touch Find Device.

The recorder identifier will appear in the Select An Accessory


window.

NOTE
The time it takes to find a device can vary from a few sec-
onds to several minutes depending on the number of Blue-
tooth devices in the area and on other electronic conditions.

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3. Touch the identifier to select the recorder.


The recorder identifier will now appear in the device list.

After selecting the recorder in the Select An Accessory list, the re-
corder and the iOS app will be "Bluetooth paired". If the recorder
has not been paired with this iOS app before, the iOS operating
system will require the user to accept the Bluetooth pairing re-
quest.

Once a SEER recorder is found and successfully paired with the


device, it will be displayed in the list of connected devices.

4. Select the desired recorder from the connected devices list to


move to the overview screen. Refer to the ”Electrode Placement
and Waveform Preview” section on page 78 for next steps.

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NOTE
If the recorder is in the process of recording or contains a re-
cording, a warning is displayed.

Electrode Placement and Waveform Preview


WARNING
WAVEFORM DIAGNOSTIC QUALITY – The ECG waveforms shown on
the preview screen are used for assessing the quality of the connec-
tions only.
Do not use these preview waveforms for diagnostic purposes.
CAUTION
SIGNAL QUALITY – If there is a severe muscle interference or artifact
on the ECG when you tap the top of the electrodes lightly or when the
patient moves, it is possible that the electrodes are not attached properly.
To increase the accuracy of analysis, make sure that the channel has
a high amplitude of QRS complex. If the amplitude is small, shift the
electrodes to find a suitable location for electrode attachment.

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The app will display a torso image with the recommended electrode placement.
The system will automatically detect the cable type and display the appropriate
configuration. Double-tap the torso to zoom in or to zoom out again.

The two associated electrodes are displayed to the left of each waveform.
If an electrode is loose, a red line will be shown around the respective
electrode pair and a red indicator will be shown on the torso.
The app will display waveforms for each channel. To zoom in on a channel
or to zoom out again, double-tap the respective waveform.

Verify or Change Settings


The Apple iOS app allows you to verify or change both the battery type
and recording duration.

Select Standard or Rechargeable Battery


To get an accurate battery life reading, identify the type of battery being
used by selecting either the standard alkaline battery icon or the re-
chargeable battery icon at the bottom left of the screen.

Standard Alkaline Battery

Rechargeable Battery

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Select Recording Duration


To select the recording duration, touch the duration button at the bottom
of the screen and select the number of days. To set a custom duration,
touch Custom and scroll to the desired time. Then touch Set.

The Autodelete Option


The Autodelete option is a setting of the recorder. The default setting of
the recorder is Autodelete On. If this is changed, the application detects it.
To automatically delete recordings after they are read into the Holter
analysis system, set Autodelete to On.
To manually delete recordings after they are downloaded into the Holter
analysis system, set Autodelete to Off.

Start the Recording


Touch the start button at the bottom of the screen to start the
recording.
If the battery state is not sufficient, a message is displayed and the re-
cording cannot be started. Replace the battery.
Upon successful recording start, the recorder will double beep and the
Event LED will now be intermittent flashing green.

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Devices Tab
In the Devices tab, you can connect to a recorder while it is recording or
after having finished.
NOTE
If the recorder is already recording, you need to activate the re-
corder’s Bluetooth module by pressing the Event Button of the re-
corder for more than three seconds until a multi-beep sounds.

 Touch Find Device to pair new recorders with the app.


 If you select the recorder in the list, you can:
o view the Hookup screen while a recorder is recording,
o view patient data, recorder serial number, cable serial number,
recorder time, battery level,
o stop and delete existing recordings or delete patient information
stored on the recorder, and
o start a recording either with the patient data stored on the re-
corder or without patient data.
Use these icons to start, stop, or delete a recording:

Start

Stop

Delete

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7
7 Using the Microsoft Windows App

If the administrator has already prepared the app for being used by ECG
technicians, you may skip to the section “Starting the App and Changing
the Technician Password” on page 88.

Installing and Setting up the App


WARNING
INTERFERENCES POSSIBLE – Safe and effective use of the SEER 1000
Mobile Application can only be performed with suitable hardware.
The personal computer (PC) used must comply with the most recent
version of the international standard EN IEC 60950.

Hardware Specifications
Hardware having the following minimum specifications is required.
Component Description

Computer Core i§ 3 GHz Processor or performance equivalents


Operating system Windows 7, 8, 10 (32-bit or 64-bit)
CPU clock 1 GHz
RAM 1 GB
Free Hard Disk Space 5 GB
Display 1024 x 768 pixels
Port One free USB port needed for Bluetooth Adapter

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Component Description

Keyboard Standard PS/2, USB, or wireless device


Mouse Standard PS/2, USB, or wireless 2- or 3-button device
Installation media One CD

Using the Bluetooth Adapter


The PC app works exclusively with the Microsoft Generic Bluetooth Driver.
After the Bluetooth adapter available with the PC app has been inserted
into a USB port, it is detected by the Microsoft Bluetooth driver.
Any other Bluetooth drivers must be deactivated.

Installing and Starting the PC App


1. Insert the installation CD into your CD drive and follow the on-
screen prompts.
If the auto-start function on your PC is deactivated, you need to
access the CD via the Windows Explorer and double-click the
setup.exe file to start the installation.

When the installation is complete, the PC app icon is placed on


the desktop.

2. Double-click the desktop icon to start the PC app.

To display the version of the app, place the mouse cursor over the GE logo
in the upper left corner of the app window.

Removing the PC App


The app can be removed by opening Control Panel on the PC and going to Add
or Remove Programs or Programs and Features and removing SEER 1000.
If the app is re-installed later, the administrator password and technicians
that were previously set up will be restored. If all previous settings need to

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be removed, follow the Reset Application procedure described later in


this chapter.

Changing the Administrator Password


The app is password protected to avoid unintentional access to a re-
corder. On your first login the user will be prompted to overwrite the de-
fault password and replace it with a new password.

NOTICE
UNAUTHORIZED ACCESS TO THE RECORDER – The administrator pass-
word is used to secure the recorder from unauthorized access.
Change the password whenever necessary, e.g., if it has been com-
municated to unauthorized people.
NOTE
Only the administrator can create Technician IDs and reset pass-
words to the default password.
The app always opens to the Login screen.
1. When the app is started for the first time, you are requested to
change the Default Administrator Password.
This is a prerequisite for adding new technicians to the list or for
resetting technician passwords.

2. Enter the Default Administrator Password: 14012013

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3. Replace the Default Administrator Password by entering and


setting your new password.
Your new password must be at least eight characters long.

Add Technician or Reset Technician Password


1. Click the  symbol to create a new technician ID.

2. Enter the Technician ID.

3. Click Next Technician if you want to enter another Technician ID.


4. Click Save to enter the Technician ID and close the dialog.
5. Click Logout to return to the Technician Login screen.

The first time the technician logs in, he/she will be required to set up a
new password. The default technician password is 20130114. The new
password must be at least 8 characters long. Then the technician can
begin to use the app.

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To reset a technician password, the administrator has to perform the fol-


lowing steps:

1. Log in as administrator.

Touch Administration in the upper right corner and enter the ad-
ministrator password.

2. Select the technician in the list.

3. Click the  symbol to open the Edit Technician window.

4. Click Reset Password. The password of this technician is reset to


the technician default password 20130114.

5. Click Save.

6. Click Logout to return to the Technician Login screen.

Reset Application
If the administrator forgets the administrator password, the system can
be reset to default settings.
NOTICE
Reset Application deletes all the data on the app and resets it to fac-
tory defaults.
Resetting the application will:
 Restore the Administrator Password to the default password.
 Delete all technician IDs and passwords.
 Delete all patient information stored in the app.
 Delete stored recorder information.

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To reset the application:


1. Click Reset Application in the Administration screen.

2. Enter the Default Administrator Password: 14012013


3. Click Login.
4. Confirm the prompt.

Starting the App and Changing the Technician Password


The app is password protected to avoid unintentional access to a re-
corder. On your first login the user will be prompted to overwrite the de-
fault password and replace it with a new password.

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1. Click the app icon to open the Microsoft Windows app.

2. Enter the ID that has been set up for you by your administrator.
3. Enter the default password: 20130114

4. Click Login.
5. Replace the default password by entering and setting your new
password.
Your new password must be at least eight characters long.

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Patient Hookup
If you have prepared the recording as explained in the “Preparing the Re-
cording” section on page 41, you can start the recording using the
Hookup tab of the app.
When logging in, the app opens in the Hookup tab.

Add or Select a Patient, Connect to the Recorder


1. Click the  symbol to add a new patient.
2. Enter the patient demographic data.
You have to enter at least the Patient ID.

Use the tab key to skip between the entries.

In the Date of Birth field, you can either use the keyboard to en-
ter the date or you can select day, month, and year using the
<left> and <right> arrow keys and then use the <up> and
<down> arrow keys to change the values.

3. Click Continue if you want to start a recording for this patient.

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4. If the patient has been previously entered into the app, double-
click the patient name or click the patient entry and then the 
symbol.

5. If the recorder is not yet turned on, press the Event Button until
you hear a beep.
6. Click the  symbol to start the device search.
NOTE
The time it takes to find a device can vary from a few sec-
onds to several minutes depending on the number of Blue-
tooth devices in the area and on other electronic conditions.

7. Click Cancel after the message Searching for new device has
changed to (Number) new device(s) found.

8. Double-click the recorder or click the recorder entry and then the
 symbol.

When first connecting to a device, you will either be asked to en-


ter the PIN code 1234 or to confirm the PIN code displayed in or-
der to enable a Bluetooth connection to this device.

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Refer to the “Electrode Placement and Waveform Preview” section on


page 92 for next steps.
If the connection cannot be established, you will be asked to try again.
NOTE
If the recorder is in the process of recording or contains a recording, a
warning is displayed.

Electrode Placement and Waveform Preview


WARNING
WAVEFORM DIAGNOSTIC QUALITY – The ECG waveforms shown on
the preview screen are used for assessing the quality of the connec-
tions only.
Do not use these preview waveforms for diagnostic purposes.
CAUTION
SIGNAL QUALITY – If there is a severe muscle interference or artifact
on the ECG when you tap the top of the electrodes lightly or when the
patient moves, it is possible that the electrodes are not attached
properly.
To increase the accuracy of analysis, make sure that the channel has
a high amplitude of QRS complex. If the amplitude is small, shift the
electrodes to find a suitable location for electrode attachment.
The app will display a torso image with the recommended electrode
placement. The system will automatically detect the cable type and dis-
play the appropriate configuration. Double-click the torso to zoom in or to
zoom out again.
NOTE
Click the  symbol to produce a screenshot of the waveform preview
screen for documentation purposes. This screenshot is placed into
the Windows clipboard.

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The two associated electrodes are displayed to the left of each waveform.
If an electrode is loose, a red line will be shown around the respective
electrode pair and a red indicator will be shown on the torso. Double-click
the waveform to zoom in or to zoom out again.

Verify or Change Settings


The app allows you to verify or change both the battery type and record-
ing duration.

Select Standard or Rechargeable Battery


To get an accurate battery life reading, identify the type of battery being
used by selecting either the standard alkaline battery icon or the re-
chargeable battery icon at the bottom left of the screen.

 Standard Alkaline Battery

 Rechargeable Battery

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Select Recording Duration


To select the recording duration, click the duration button at the top of
the screen and select the desired number of days and hours. Then click
Save.

The Autodelete Option


The Autodelete option is a setting of the recorder. The default setting of
the recorder is Autodelete On. If this is changed, the application detects it.
To automatically delete recordings after they are read into the Holter
analysis system, set Autodelete to On.
To manually delete recordings after they are downloaded into the Holter
analysis system, set Autodelete to Off.

Start the Recording


Click the start button  at the top of the screen to start the recording.
If the battery state is not sufficient, a message is displayed and the re-
cording cannot be started. Replace the battery.
Upon successful recording start, the recorder will double beep and the
Event LED will now be intermittent flashing green.

94 SEER™ 1000 2067634-077 Revision F


Using the Microsoft Windows App

Patients Tab
In the Patients tab, you can view, edit, and delete patient entries. Also,
you can add patients to the list for later recordings.

 To view the patient list, click the Patients tab.


 To delete a patient, select the patient and click the  symbol.
 To edit a patient, click the  symbol and enter and save your edits.
You have to enter at least the Patient ID.

 To add a patient, click the  symbol and enter the patient demo-
graphic data. Then do one of the following:
o Click Save to save and go back to the patient list.
o Click Add Next Patient to add more patients to the list.

2067634-077 Revision F SEER™ 1000 95


Using the Microsoft Windows App

Devices Tab
In the Devices tab, you can connect to a recorder while it is recording or
after having finished.
NOTE
If the recorder is already recording, you need to activate the re-
corder’s Bluetooth module by pressing the Event Button of the re-
corder for more than three seconds until a multi-beep sounds.
NOTE
The device information Serial Number and Maximum Duration as
well as the firmware and hardware versions are not displayed before
the recorder and the app have been paired for the first time.

Double-click the device or click the device entry and then the  symbol.
 If you select the recorder in the list, you can:
o view the Hookup screen while a recorder is recording,
o view patient data, recorder serial number, cable serial number,
recorder time, battery level,
o stop and delete existing recordings or delete patient information
stored on the recorder, and
o start a recording either with the patient data stored on the re-
corder or without patient data.
To delete a recorder from the list, select the recorder and click the  symbol.
Use these icons to start, stop, or delete a recording:

 Start
 Stop
 Delete

96 SEER™ 1000 2067634-077 Revision F


8
8 Troubleshooting

This section explains error signs and troubleshooting recommendations.

Recorder Troubleshooting
Trouble Indicators Cause Recommendation

The Event Button LED Battery power is low. The battery is not fully charged
flashes yellow once or the wrong battery type has
every second. been inserted. Replace with
An error tone sounds new alkaline battery or NiMH
when you try to start the rechargeable battery.
recording.

The Hookup Guidance Electrode or ECG cable is not Connect the ECG cable or re-
LED flashes yellow once connected. connect loose electrodes.
every second.
An error tone sounds
when you try to start the
recording.

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Troubleshooting

Trouble Indicators Cause Recommendation

The Event Button LED is Previous recording or patient To start a new recording, de-
a solid yellow. entry has not been deleted. lete the recording and/or pa-
tient demographic data using
either the Holter analysis sys-
tem software or the SEER 1000
app.

The Event Button LED The recording has stopped The recording may have been
stops flashing green before the specified record- started with a low battery.
during specified record- ing duration has been Download or delete the record-
ing duration. reached. ing and replace the battery to
start a new recording.
Check the unit for physical
damage. If the unit is dam-
aged, contact service.

The Event Button LED Recorder cannot be started. See section “How to Notify Ser-
and the Hookup Guid- Self-test failed. vice if the Recorder is Defec-
ance LED flash green tive” on page 108.
and yellow alternating
three times every sec-
ond.

98 SEER™ 1000 2067634-077 Revision F


Troubleshooting

Application Troubleshooting
Message Recommendation

“A technician with the same identifier Enter a new technician identifier.


exists already.”

“An error occurred while connecting. Try again to connect to the recorder.
You should try again.”

“Battery level too low to start a record- For the recording duration selected, the battery
ing.” is not sufficiently charged or the wrong battery
type has been inserted.
Insert a new alkaline or a fully charged NiMH
battery, or reduce the recording duration.

“Battery low. Recorder is shutting Insert a new alkaline or a fully charged NiMH
down.” battery.

“Data could not be deleted. Please If the recorder is currently connected to an eval-
check if the SEER recorder is connected uation software via USB, e.g., to transfer a re-
to another software.” cording, wait until this data exchange is termi-
nated and then disconnect the USB cable before
you re-try to delete the data.

Data stored on recorder. Do you want Delete the data stored on the recorder or down-
to select a different recorder? load it to the an evaluation software.
Alternatively, select another recorder.

“Deleting recording failed.” Try again as the wireless communication may


have been interrupted.

“Password too short. A password must Enter a new password with at least eight charac-
have at least 8 characters.” ters.

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Troubleshooting

Message Recommendation

“Recorder “SN” is no longer paired with (Message from Microsoft Windows)


this PC. Do you want to repeat the pair- Select “Yes”.
ing procedure for this recorder?”
The pairing procedure is executed automatically.

“Recorder is no longer paired with this (Message from Apple iOS)


device. Please repeat the pairing pro- 1. Close the app.
cess for this recorder.”
2. Call up the Apple iOS Settings menu.
3. Select the Bluetooth tab.
4. Select the “Forget this device” option.
5. Select the recorder.
6. Repeat the pairing process for this recorder.

“Recorder is recording. Do you want to A recording is already running. Stop and delete
select a different recorder?” the recording or select a new recorder.

“Resetting recorder failed.” Try again as the wireless communication may


have been interrupted.

“Setting autodelete flag failed.” Try again as the wireless communication may
have been interrupted.

“Setting battery type failed.” Try again as the wireless communication may
have been interrupted.

“Setting measurement duration failed.” Try again as the wireless communication may
have been interrupted.

“Setting patient data failed.” Try again as the wireless communication may
have been interrupted.

“Setting recorder protection key failed.” Try again as the wireless communication may
have been interrupted.

100 SEER™ 1000 2067634-077 Revision F


Troubleshooting

Message Recommendation

“Starting recording failed.”  If the recording is running (Event Button LED


flashes intermittently green), no recorder
feedback has been registered in the app
and the patient has not been automatically
deleted from the list after the start of the re-
cording. In this case, go to the Patients tab
and delete the patient manually.
 If the recording is not running but the wave-
forms are displayed (Event Button LED
shows solid green), try again to start the re-
cording.
 If the recording is not running and no wave-
forms are displayed, repeat the procedure
beginning with selecting the patient.

“Technician “x” not found.” The technician ID does not exist. Enter a valid
technician ID.

“The passwords entered do not match.” The repeated password must be identical to the
first one entered.

2067634-077 Revision F SEER™ 1000 101


Troubleshooting

Message Recommendation

“The protection key stored in the re- The recorder is currently protected by a key gen-
corder does not match the current ad- erated from another administrator password.
ministrator passwo rd.” Use an app controlled by the correct administra-
tor password or ask your administrator to reset
the recorder using the PC or iOS app.
NOTE:
If the administrator changes his or her
password, recorders protected by the pre-
vious administrator password are no
longer accessible until the data has been
downloaded and deleted.
NOTE:
If the recorder has started automatically or
has been manually started using the Event
Button, a protection key is automatically
generated by the recorder. In this case,
wireless access is no longer possible until
the data has been downloaded and de-
leted.

“Unable to establish a connection.” Check if Bluetooth is enabled on the


SEER 1000 recorder and try again.
Check if Bluetooth is enabled on your Apple iOS
device.
Ensure that your PC or Apple mobile device is not
already connected to another Bluetooth device.
On the PC application device, disable any built-in
Bluetooth module.

“Wrong password.” The password is wrong. Try a valid password.

“Wrong technician or password.” The technician ID does not exist or the password
is wrong. Try a valid combination of technician ID
and password.

102 SEER™ 1000 2067634-077 Revision F


Troubleshooting

Bluetooth Troubleshooting
Trouble Indicators Cause Recommendation

Error while connecting Recorder and app device are For best results, do not position
recorder and app either too close to or too far the devices closer than 50 cm
away from each other. (approx. 20 inches) to each
other or more than 10 m (ap-
prox. 11 yards) from each
other.

The app device's Bluetooth Verify that your device's Blue-


connectivity is not enabled. tooth connectivity is enabled.

Objects between recorder Remove any objects from the


and application device affect line of sight between recorder
the connection. and application device.

RF interfering devices affect Remove any possible RF interfer-


the connection. ing devices from the vicinity of re-
corder and application device.

After starting a record- The recorder's Bluetooth Press and hold the Event But-
ing, no wireless connec- connectivity is not enabled ton for approx. 3 seconds until
tivity active because this is switched off the multi-beep indicates wire-
after the start of a recording. less connectivity is activated.

2067634-077 Revision F SEER™ 1000 103


Troubleshooting

MUSE Orders Troubleshooting


Trouble Indicators Cause Recommendation

MUSE Connection Test Improper URL. The URL to be entered needs to be


failure during setup. the base URL for the REST interface
Query Orders button followed by the port number, e.g.,
missing from Add Pa- http://192.168.0.201:8100.
tient tab. Wrong HostName or IP Confirm proper HostName and/or IP
address. address of the MUSE System.
HostName to IP ad- Confirm HostName resolution /
dress lookup (DNS) not lookup is working on iOS device.
functioning. Try entering the IP address of the
MUSE system in URL.
Wrong IP Port used for The proper listening IP PORT number
MUSE API. of the MUSE API service (default
8100) must be included as part of
URL configuration.
MUSE API service is not Confirm with MUSE Administrator or
running. GE support that the MUSE API ser-
vice is configured properly and is
running without errors.
User Name or Pass- Confirm that the configured User
word is not a valid and Password match that of a valid
MUSE User. MUSE User.
Other network com- Check for other network communi-
munication fault or cation faults, restrictions, and fire-
port blocking. walls.
No MUSE Patient/Exam Improper “Site Num- Confirm the presence of MUSE or-
Orders displayed in Or- ber" in configuration. ders with proper Site number.
der List.
No Holter Orders with Confirm the presence of MUSE or-
OPEN order status. ders with:
TestType=Holter
Status=OPEN

104 SEER™ 1000 2067634-077 Revision F


Troubleshooting

Bluetooth Messages from the Microsoft Windows


System
Certain problems when establishing Bluetooth connectivity between PC
and recorder are reported by the operating system of the PC.
The app tries to suggest a solution but cannot always determine the rea-
son of the problem. In this case, the system messages and the respective
error codes are displayed. These messages and error codes can be inter-
preted by the Windows system administrator.
You can try the following:
 Check if Bluetooth is enabled on the recorder and try again.
 If a recording is running, press and hold the Event Button until the
multi-beep indicates wireless connectivity is activated.
 On the PC application device, disable any built-in Bluetooth module.

Resetting the recorder with the iOS App


NOTICE
Resetting the recorder deletes all the data on the recorder and resets
the protection key.
The recorder can be reset as follows:
1. Switch on the recorder.
2. Start the app.
3. Log in using your Admin ID or technician ID and the correspond-
ing password.
4. Click Login.
The Patients tab opens.

5. Change to the Devices tab.

2067634-077 Revision F SEER™ 1000 105


Troubleshooting

6. Select the recorder.


If the recorder to be reset is not listed, click the Find Device op-
tion.

7. Once the recorder to be reset is listed, touch the information


symbol on the right of the entry. A window opens where you
click the Reset field.

A message confirms that the recorder has been reset.

106 SEER™ 1000 2067634-077 Revision F


Troubleshooting

Resetting the Recorder with the Microsoft Windows App


NOTICE
Resetting the recorder deletes all the data on the recorder and resets
the protection key.
The recorder can be reset as follows:
1. Switch on the recorder.
2. Start the app.

3. Type “administrator” in the first line of the Login window.


4. Enter the Administrator Password in the second line.
5. Click Login.
The Hookup tab opens.

6. Change to the Devices tab.

7. Select the recorder.


8. If the recorder to be reset is not listed, click the  symbol.
9. Once the recorder to be reset is listed, select it with a single click
and click Reset. A message confirms that the recorder has been
reset.

2067634-077 Revision F SEER™ 1000 107


Troubleshooting

How to Notify Service if the Recorder is Defective


If the recorder is defective, it will be detected during the self-test when the
recorder is switched on. In case a defect is detected during the self-test,
the following sequence of LED flashes will alert you that a problem has
been detected:
 Both LED flash yellow.
 Both LED flash green.
 A two-second pause follows.
 The green Event Button LED flashes.
If any of these failures occur, contact GE Technical Support. By counting
the number of flashes, service personnel can determine the cause of the
defect.
Refer to the following table for the defect identified by the number of LED
flashes.
Failure number Failure
(Count of LED
flashes)

1 The firmware CRC check fails. The board needs to be reprogrammed.


2 A fault has been detected with the internal RAM.
3 One or more of the different internal clocks fails.
4 The communication between the µC and the NAND-Flash fails.
5 The NAND-Flash has too many bad blocks.
6 The communication to the Bluetooth module fails.
7 The RTC (Real Time Clock) is in an error state. Restart of the device may fix
the problem.

NOTE
Recorders with detected failures and observed damage should be re-
turned to GE support for repair.

108 SEER™ 1000 2067634-077 Revision F


9
9 Maintenance

This chapter informs you about cleaning or disinfecting the different parts
of the system as well as about storing the ECG cables and checking the
cable connections.

Cleaning and Disinfection


Only use these cleaning agents and disinfectants with the following ingre-
dients:
 Ethyl alcohol (70 - 80%)
 Isopropyl alcohol (70 - 80%)
 Glutaraldehyde disinfectant 2% (pH 7.5 – 8.5)
 Hydrogen peroxide disinfectant 1.5%
• Sodium hypochlorite disinfectant (5% household bleach) minimum
1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10
dilution.
NOTICE
DAMAGE TO THE EQUIPMENT – Chemical substances other than those
recommended above may damage the plastic of the device casing
and cables.
 Solutions containing the following compounds are known to damage
the product:
o Dimethyl Benzyl Ammonium Chloride

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Maintenance

o Quaternary Ammonium Chloride solutions


o Abrasive cleaners or solvents of any kind
o Acetone
o Ether / petroleum ether
o Ketone
o Betadine
o Sodium salts
 Use cleaning and disinfection agents only in accordance with the
manufacturer's instructions and be sure to use the correct dilution
factor given in these instructions.
 The recorder and accessories must not be sterilized.
 Never autoclave or steam-clean the device, cables, or leadwires.
NOTICE
DEGRADATION OF SIGNAL QUALITY – Some substances are conduc-
tive or insulating and can affect signal quality.
 Solutions containing the following compounds are known to degrade
signal quality:
o Chlorides
o wax, or wax compounds
 Never immerse the device or cables in any liquid, as this may corrode
metal contacts and affect signal quality.
 Wring excess disinfectant from the wipe before using it.
 Do not use any of the accessories until thoroughly dry.
 Do not allow fluid to collect around the connection pins. If this hap-
pens, blot them dry with a soft, lint-free cloth.

110 SEER™ 1000 2067634-077 Revision F


Maintenance

Cleaning and Disinfecting the Recorder


Use the following procedure to clean/disinfect the recorder:
1. IMPORTANT – Make sure the patient cable is attached to the recorder
during the cleaning process to avoid fluid ingress.
2. Remove the battery and close the battery compartment door before
cleaning the recorder.
3. To clean the recorder, wipe the surface with a cloth slightly mois-
tened with a mild solution of soap and water, or with a 70% alcohol
solution. Make sure that the cloth or tissue is not too moist, so that no
fluid can be squeezed from it.
4. Disinfect the device at regular intervals, prior to first use, and before
passing it on between patients.
5. After wiping the device with the disinfectant wait for the appropriate
exposure time given in the instructions provided for the disinfectant.
Then remove any residue by wiping with a clean cloth lightly mois-
tened with water and wait until the recorder is completely dry.

Cleaning the Carrying Pouch


Clean the pouch by hand using a mild soap solution. Alternatively, you can
machine wash the pouch at 60°C (140°F).
Dry thoroughly before use. Do not spin dry.
To disinfect wipe the surface with a cloth slightly moistened with a 70%
alcohol solution.

Cleaning, Disinfecting, and Storing ECG Cables


To keep the system clean and in good repair, it is important to keep the
cables and leadwires clean and disinfected. This section provides instruc-
tions for cleaning, disinfecting, and storing ECG cables and leadwires to
extend their life and protect patients.
Proper cleaning and disinfecting prolongs the life of the cables and
leadwires.

2067634-077 Revision F SEER™ 1000 111


Maintenance

CAUTION
DAMAGE TO THE EQUIPMENT – Failure to use the proper cleaning solu-
tions or to follow the proper procedures can result in the following:
 Damage or corrosion
 Diminished signal quality
 Product discoloration
 Metal part corrosion
 Brittle wires and connectors
 Reduced lifetime of cables and leadwires
 Device malfunction
 Voided warranty

Use the following procedure to clean/disinfect the cables and leadwires:


To clean the cable, wipe the surface with a cloth slightly moistened with a
mild solution of soap and water or with a 70% alcohol solution. Make sure
that the cloth or tissue that is used is not too moist, so that no fluid can be
squeezed from it.
To disinfect the cable, observe the following guidelines:
Disinfect the cable at regular intervals, prior to first use, and before pass-
ing it on to another person.
Only use these cleaning agents and disinfectants:
 Glutaraldehyde disinfectant 2% (pH 7.5 – 8.5)
 Hydrogen peroxide disinfectant 1.5%
 Sodium hypochlorite disinfectant (5% household bleach) minimum
1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10
dilution.

112 SEER™ 1000 2067634-077 Revision F


Maintenance

 When cleaning/disinfecting the single leadwires it is recommended to


hold the cable at the leadwire itself as shown in the picture below.
Use only light pressure between the finger tips, when pulling the wipe
along the leadwire.

 Do not allow fluid to collect around the connection pins. If this hap-
pens, blot them dry with a soft, lint-free cloth.
 The cable must not be sterilized.
 After wiping the device with the disinfectant wait for the appropriate
exposure time given in the instructions provided for the disinfectant.
Then remove any residue by wiping with a clean cloth lightly mois-
tened with water and wait until the device is completely dry.

Storing ECG Cables


Store cables and leadwires by hanging them vertically in a dry, well-venti-
lated area. Do NOT coil leadwires or cables around the device.

2067634-077 Revision F SEER™ 1000 113


Maintenance

Cleaning the Battery Contacts


Visually inspect the battery contacts before every use for obvious dirt or
corrosion. In these cases, thoroughly clean the battery contacts using a
cotton swab slightly moistened with a 70% alcohol solution.

Checking ECG Cable and Connectors


Visually inspect the ECG Cable, connectors, and battery contacts regularly
before use. Check the ECG signal quality by using an ECG simulator to-
gether with the Hookup application.

114 SEER™ 1000 2067634-077 Revision F


A
A Specifications

This section lists the specifications for the SEER 1000 recorders.

General
Component Description

Recording channels 2 or 3 channels ECG, depending on the ECG cable


type connected
Pacemaker pulses
Pacemaker detection All channels
Recording time 24 hours, 48 hours, or 7 days, depending on model
Lead off detection Yes
Defibrillator Proof No
Connectors One connector for ECG and USB combined
LEDs Event Button LED, Hookup Guidance LED
Buttons One button for on/off and patient event marker
Time data backup Within 1 month
Time accuracy ± 30 seconds per month
(Clock synchronized with the app device clock
when recording started)
Recording method Digital memory, non-removable
Data transfer method USB 2.0

2067634-077 Revision F SEER™ 1000 115


Specifications

Electrical
Component Description

Battery type 1 x LR03/AAA 1.5 V alkaline, or


1 x HR03/AAA 1.2 V NiMH rechargeable, 1000 mAh
Frequency response 0.05 to 70 Hz
Analog-to-digital converter 1024 Hz, 12 bit (2.93 µV)
ECG data storage 256 Hz, 12 bit (2.93 µV)
Input voltage range ECG ± 6 mV
Common mode rejection CMR > 80 dB per channel
Input impedance > 10 MΩ

Mechanical
Component Description

Dimensions Height: 64 mm (2.52 inches)


Width: 71 mm (2.80 inches) without cable
Width: 84 mm (3.31 inches) with cable
Depth: 20 mm (0.79 inches)
Weight 53 g (1.87 ounces) without battery,
63 g (2.22 ounces) with battery
Material EMERGE PC/PET 9500CR (main body)
Ingress protection IP43
Vibration endurance Operation: 0.5 G (10 to 20 Hz)
Non-operation: 3.0 G (100 to 300 Hz)

116 SEER™ 1000 2067634-077 Revision F


Specifications

Environmental
Component Description

Operating temperature 5 to 45°C (41 to 113°F)


Operating humidity 5 to 95% relative humidity, non-condensing
Storage temperature – 25 to 70°C (– 13 to 158°F)
Storage humidity 0 to 90% relative humidity, non-condensing
Ambient pressure 1060 to 700 hPa
(-380 m to 3000 m / -1,247 to 9,843 ft.)

Bluetooth module
Component Description

Approval RTTE Directive 1999/5/EG


Transmission technology Bluetooth 2.1 +EDR, class 2
Range Up to 10 m (10.93 yards) free field
HF Frequency range 2400 to 2483.5 MHz, ISM Band
Receiving signal – 82 to -20 dBm
Output transmission power – 11 to 3 dBm

2067634-077 Revision F SEER™ 1000 117


Specifications

EMC Specifications according to IEC 60601-1-2


General Specifications
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or
the user should ensure that the device is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions Group 1 The device uses RF energy only for its internal function. There-
CISPR 11 fore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions Class B The device is suitable for use in all establishments, including
CISPR 11 domestic establishments and those directly connected to the
public low-voltage power supply network that supplies build-
Harmonic Not applicable ings used for domestic purposes.
emissions
IEC 61000-3-2
Voltage fluctua- Not applicable
tions / Flicker
emissions
IEC 61000-3-3

118 SEER™ 1000 2067634-077 Revision F


Specifications

Electromagnetic immunity (line-bound disturbances)


Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or
the user should ensure that the device is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment –
test level level guidance
Electrostatic dis-  8 kV contact  8 kV contact Floors should be wood, concrete, or
charge (ESD) (electrode snaps ceramic tile. If floors are covered
IEC 61000-4-2 only, direct dis- with synthetic material, the relative
charge on device humidity should be at least 30%.
not possible due to
pouch)
 15 kV air  15 kV air
Electric fast transi-  2 kV for power Not applicable Not applicable (battery powered
ent / burst supply lines device)
IEC 61000-4-4  1 kV for input /
output lines
Surge  1 kV Not applicable Not applicable (battery powered
IEC 61000-4-5 differential mode device)
 2 kV
common mode
Voltage dips, short 5% UT (>95% dip in Not applicable Not applicable (battery powered
interruptions and UT) for 1/2 period device)
voltage variations < 5% UT (>95% dip
on power supply in UT) for 1 period
input lines
IEC 61000-4-11 70% UT (30% dip in
UT) for 25 periods
<5% UT (>95% dip in
UT) for 5 s
Power frequency 30 A/m Not applicable Not applicable
(50/60 Hz)
magnetic field IEC
61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.

2067634-077 Revision F SEER™ 1000 119


Specifications

Electromagnetic immunity (conducted and radiated RF dis-


turbances)

The device is intended for use in the electromagnetic environment specified below. The customer or the
user should ensure that the device is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment – guid-
test level level ance
Conducted RF 3 V effective value 3 V effective value Portable and mobile RF devices are not
IEC 61000-4-6 150 kHz to 80 MHz used at closer than 30 cm to the device
including leads
6 V effective value 6 V effective value in
in the ISM bands the ISM band ac-
between 0,15 MHz cording to table 5, The field strength of stationary radio
and 80 MHz Note N) transmitters is, as determined by an
electromagnetic site survey, at all fre-
Radiated RF 10 V/m 10 V/m quencies smaller than the compliance
IEC 61000-4-3 80 MHz to 2,7 GHz level.

Immunity against According to Interference may occur in the vicinity of


wireless RF commu- Table 9 equipment marked with the following
nication devices symbol:

120 SEER™ 1000 2067634-077 Revision F


B Index

accessories, 21 product information, 21


biocompatibility, 21 product label, 28
certification, 19 regulatory and safety information, 12
classification, 19 related documents, 33
contraindications, 12 responsibility
document conventions, 32 of the manufacturer, 21
electrode placement, 43, 44 safety
equipment identification, 28 conventions, 13
illustration conventions, 33 hazards, 13
indications for use, 12 information, 12
intended user, 12 serial number format, 29
label service
locations, 27 information, 31
product, 28 requirements, 31
manual purpose, 32 signal reproduction, accuracy of, 19
notes, 33 skin preparation, 43
package information, 21 supplies, 21
prescription device statement, 12 symbols, 21
product typographical conventions, 32
label, 28 warranty information, 31

2067634-077 Revision F SEER™ 1000 121


GETEMED Medizin- und
Informationstechnik AG
Oderstr. 77
14513 Teltow, Germany
Tel: +49 3328 3942-0
Fax: +49 3328 3942-99

DISTRIBUTOR:
GE Medical Systems
Information Technologies, Inc.

DISTRIBUTOR World Headquarters:


GE Medical Systems
Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223, USA
Tel: +1 414 355 5000
+1 800 558 7044 (US Only)

GE Medical Systems Information Technologies, Inc., a General Electric Company, going to


market as GE Healthcare.

www.gehealthcare.com

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