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SEER™ 1000
ECG Recorder and Mobile Application
Operating Manual
Version 1.0
2067634-077 Revision F
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.
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.
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
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
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.
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.
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.
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.
Safety Hazards
The following messages apply to the system as a whole. Specific mes-
sages may also appear elsewhere in the manual.
WARNINGS
WARNING
NO MONITORING DEVICE – The SEER 1000 recorder is not a monitor-
ing device and is not intended for monitoring the clinical condition of
a patient.
Do NOT use the SEER 1000 as a monitoring device.
WARNING
MIXING UP RECORDINGS –The patient’s life or health may be put at
risk if the patient is assigned a different patient’s examination, thus
resulting in an incorrectly assigned diagnosis.
Take special care to always select the correct examination and the
correct patient. To ensure that a recording is not assigned to the
wrong patient, always enter the patient’s ID into the recording me-
dium or write the patient’s ID on it before starting the recording.
WARNING
ELECTROSURGERY – There is a risk of burns and injury to the patient.
If an electrosurgery device is used, disconnect the ECG cable from the
recorder.
WARNING
EXPLOSION HAZARD – Electrical sparks can cause explosions in the
presence of certain gases.
Do not use device in an oxygen-enriched environment or around
other flammable or explosive gases.
Establish whether the patient is liable to be in such an environment,
possibly for job-related reasons.
WARNING
CABLES – Cables present a possible strangulation hazard.
To avoid possible strangulation, route all cables away from patient's
throat. Use short version of cables for pediatric patients.
WARNING
CONDUCTIVITY – Electric shock or device malfunction may occur if
electrodes contact conductive materials.
Keep the conductive parts of lead electrodes and associated parts
away from other conductive parts, including earth. Also make sure
that no contact to other conductive parts is possible if the electrodes
loosen during recording.
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.
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.
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.
NOTICE
INTERFERENCE – Electrical emissions from an electric blanket may de-
grade signal quality.
Do not use in conjunction with an electric blanket.
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
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.
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.
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.
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
Symbol Description
Symbol Description
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.
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.
Symbol Description
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.
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.
Symbol Description
Find
This symbol is selected in the Microsoft Windows app to find a
recorder for wireless connection.
Event Button
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
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
Item Description
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.
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.
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
Convention Description
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
This chapter describes the main features of the recorder. You will be pre-
sented more specific information and graphics in the following sections.
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
Event Button
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.
Prior to recording, this two-color LED indicates the following hookup sta-
tuses:
Hookup Status Hookup Guidance Light
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
Safety Precautions
Notify the doctor if skin problems develop.
In rare cases, even when using biocompatible electrodes, allergic re-
actions may occur.
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.
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).
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.
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.
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,
If any such thing is found, do NOT use the recorder service, but rather
contact GE Service to arrange for repairs.
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
NOTE
Verify that your iOS device has Bluetooth enabled. On your Apple de-
vice, open Settings, select Bluetooth and verify that it is On.
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.
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.
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.
1. Log in as administrator.
Touch Administration in the upper right corner and enter the ad-
ministrator password.
4. Touch Save.
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.
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.
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.
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 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.
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.
Add Patient
You can enter patient data manually or—if your application is configured
accordingly—retrieve patient demographic data from MUSE Orders.
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.
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.
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.
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.
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.
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.
NOTE
If the recorder is in the process of recording or contains a re-
cording, a warning is displayed.
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.
Rechargeable Battery
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.
Start
Stop
Delete
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.
Hardware Specifications
Hardware having the following minimum specifications is required.
Component Description
Component Description
To display the version of the app, place the mouse cursor over the GE logo
in the upper left corner of the app window.
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.
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.
1. Log in as administrator.
Touch Administration in the upper right corner and enter the ad-
ministrator password.
5. Click Save.
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.
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.
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.
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.
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.
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.
Rechargeable Battery
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 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.
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
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.
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.
Application Troubleshooting
Message Recommendation
“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.
“Password too short. A password must Enter a new password with at least eight charac-
have at least 8 characters.” ters.
Message Recommendation
“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.
“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.
Message Recommendation
“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.
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.
“Wrong technician or password.” The technician ID does not exist or the password
is wrong. Try a valid combination of technician ID
and password.
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.
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.
NOTE
Recorders with detected failures and observed damage should be re-
turned to GE support for repair.
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.
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
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.
This section lists the specifications for the SEER 1000 recorders.
General
Component Description
Electrical
Component Description
Mechanical
Component Description
Environmental
Component Description
Bluetooth module
Component Description
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.
DISTRIBUTOR:
GE Medical Systems
Information Technologies, Inc.
www.gehealthcare.com