GE HEALTHCARE SEER 1000 Parts list manual

GE Healthcare
SEER ™ 1000 ECG recorder and software-Portuguese app
© 2016 General Electric Company All rights
reserved
SEER ™ 1000
ECG recorder and software-app usage
instructions
version 1.0
2067634-131 Revision E

2 SEER ™ 1000 2067634-131 Revision E
November 3, 2015
About this documentation
The information in this manual are for SEER ™ 1000 ECG recorder and software-app version 1.0. They do not apply to prior versions. Due to progressive product
innovation, the specifications listed in this manual are subject to change without notice.
This manual is the development and ownership of GETEMED Medizin- und Informationstechnik AG, Oderstr. 77, 14513 Teltow, Deutschland. The product has
a registered protective trademark of GE Healthcare.
SEER and MARS are the property of brand names GE Medical Systems Information Technologies, Inc., a business of General Electric Company, which stands as
GE Healthcare.
CardioDay is a brand owned by GETEMED AG.
iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the US and other countries. "Made for iPod," "Made for iPhone," and "Made for iPad"
mean que an electronic accessory Has Been designed to connect Specifically to the iPod, iPhone, or iPad, respectivamente, and Has Been certified by the
developer to meet Apple performance standards. Apple is not Responsible for the operation of this device or its compliance with safety and regulatory standards.
Please note that the use of this device with an iPod, iPhone, or iPad may Affect wireless performance.
Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and / or other countries.
This product meets the regulatory requirements for medical devices of the following:
Revision History
The document number of the piece and the appointment of the review appear at the bottom of each page. The review refers to the level of document review.
The historical revision of this document is summarized in the following table.
Review Release date of description
THE November 8, 2013 first publication
B April 8, 2014 modified:
"Basic information about the wireless Bluetooth connection"
W May 26, 2015 EAC
D November 3, 2015 " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the
recorder "57 page" Using the Apple iOS App ", Page 61 recorder "57 page" Using the Apple iOS App ", Page 61 recorder "57 page" Using the Apple iOS App ", Page 61 recorder "57 page" Using the Apple iOS App ", Page 61
Please contact the site is representative of GE Healthcare regarding other applicable documents.

2067634-131 Revision E SEER ™ 1000 3
Content
1Introduction ................................................. .................................................. .......... 9
Target group ............................................... .................................................. ...................................... 10
Indication ................................................. .................................................. ....................................... 10
Goal ................................................. .................................................. ...................................... 10
Contraindications ............................................... .................................................. ....................... 10
Device subject to prescription .............................................. .............................................. 10
Regulations and safety information ............................................. ................... 11
The meaning of the signal words ............................................ ........... 11
Safety instructions ............................................... ........................................... 12
Medical device classification .............................................. ..................... 17
Certification ................................................. .................................................. ................... 18
Accuracy of the input signal ............................................. ..................................... 18
Warning EMS / CEM / AF ............................................ .................................................. ..... 18
Biocompatibility ................................................. .................................................. .... 19
Information on spare parts and accessories ........................... 19
manufacturer's responsibility ............................................... ............................ 20
Information on the product and packaging ............................................ ........... 20
Identification of equipment ............................................... ............................................... 28
Nameplate ............................................... .............................................. 28
serial number and format of the product code ..................................... 29
Maintenance information .............................................. ....................................... 29
Maintenance requirements: .............................................. ....................................... 29
warranty information ............................................... .............................................. 30
Additional help ................................................ .................................................. ............. 30
Information on this instruction manual ............................................ ................ 30
Manual Purpose instructions ............................................. ...................... 30
Convention for the manual ............................................ .......... 31
Other applicable documents ............................................... ............................... 32

4 SEER ™ 1000 2067634-131 Revision E
2 Product Overview .............................................. ......................................... 33
Recorder App - General ............................................. ............................................ 33
Control elements of the recorder ............................................. ................................... 34
Event button ............................................... .................................................. ............ 35
LED of the event buttons ............................................. ........................................... 36
LED of electrodes ............................................... .................................................. 36 .........
Acoustic messages ................................................ .................................................. 37
3Preparing for recording ............................................... ........................................... 39
Inform the patient ............................................... .................................................. ................... 40
Safety notes for the patient ............................................ ..................... 40
Recording daily ............................................... .................................................. ...... 41
Mark patient event .............................................. ........................................... 41
Prepare the patient's skin ............................................. .................................................. .... 41
electrodes installation ............................................... .................................................. ........... 42
Arrangement electrodes 7 to three ECG channels ......................................... 43
5 Electrode arrangement for two ECG channels ......................................... 44
Layout of 3 electrodes for recording 3-channel ECG nãoindependentes
..................................... .................................................. ........ 45
Connect the ECG cable to the recorder and the electrodes ...................................... 46
Place the stack ............................................... .................................................. .............................. 47
Replace or replace the battery cover ........................................... ............................ 48
Connecting Recorder ............................................... .................................................. .......................... 49
Start recording ............................................... .................................................. ....................... 49
Auto-Start ............................................... .................................................. ......................... 50
Automatic shutdown ................................................ ........................................ 51
4Measures after the end of the recording ............................................ ...................... 53
Turn off the recorder before the end of the recording .......................................... ............... 53
Drop electrodes ................................................ .................................................. ........................... 53
Import recording to the PC ............................................ ................................................ 54
compatible evaluation software .............................................. ........................ 54

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5Apps - General information .............................................. ................................. 55
Functionality ................................................. .................................................. ........................... 56
Privacy policy ............................................... .................................................. ............. 57
data protection in the App ............................................. .......................................... 57
Data protection on the recorder ............................................. .............................. 57
Basic information about the wireless connection Bluetooth ..................................... 58
6 Using the Apple iOS App ............................................. ................................ 61
Install and configure the application ............................................. ............................................ 61
Install and launch the application ............................................. ...................................... 61
Change the admin password ............................................. ........................... 62
Add technical or reset the password coach ........................................ 63
Configure the connection to MUSE wish list .......................................... ..66
Reset the application ............................................... .................................................. ..... 68
Start the application and change the technician password ......................................... ..................... 68
Save technician ID .............................................. .................................................. ................ 69
The tab "Patient" - Prepare and start ECG recording ...................................... .... 70
Add patients ................................................ .................................................. ... 70
Change or delete patient input ............................................ ................ 73
Search appliance ................................................ .................................................. ....... 74
Arrangement of electrodes and signal quality ........................................... ..76
Check or change the settings ............................................. .................... 77
Start recording ............................................... .................................................. ........ 78
The "Device" tab ............................................. .................................................. .................... 78
7 Using Microsoft Windows App ............................................. ............... 81
Install and configure the application ............................................. ............................................ 81
Hardware specifications ............................................... .................................... 81
Using a Bluetooth adapter .............................................. ................................. 82
Install and launch the PC application ........................................... ........................... 83
Remove PC App ............................................... .................................................. ........... 83
Change the admin password ............................................. ........................... 83
Add technical or reset the password coach ........................................ 85
Reset the application ............................................... .................................................. ..... 86
Start the application and change the technician password ......................................... ..................... 87

6 SEER ™ 1000 2067634-131 Revision E
Prepare and start the ECG guide - ECG .......................................... .......................................... 88
Add or select a patient, connect to a recorder .......................................
.................................................. ....................... 88
Arrangement of electrodes and signal quality ........................................... ..91
Check or change the settings ............................................. .................... 92
Start recording ............................................... .................................................. ........ 93
The tab "Patient" ............................................. .................................................. ........................... 93
The "Device" tab ............................................. .................................................. .................... 94
8 Problems solution ............................................... ........................................ 97
Solving problems Recorder ............................................. ...................................... 97
Application error messages ............................................. ........................................... 99
Bluetooth connection malfunctions .............................................. ............................................. 104
Connection faults MUSE .............................................. .................................................. .... 105
Bluetooth messages Microsoft Windows System ......................................... 106
Reset iOS App .............................................. .................................................. .................... 106
Reset with Microsoft Windows App ............................................. .................................... 107
How to inform the service that the recorder is defective .............................. 109
9Maintenance ................................................. .................................................. .... 111
Attention indications ............................................... .................................................. .......... 111
Clean and disinfect recorder .............................................. ............................................... 112
Clean the recorder bag ............................................. .................................................. . 113
Cleaning, disinfection and storage of ECG cables ................................ 113
Clear ECG cable ............................................... .................................................. ....... 113
Disinfect ECG cable ............................................... .................................................. 114
Storing ECG cable ............................................... 114 ................................................
Clean the battery contacts ............................................. .................................................. . 114
Check the ECG cables and connections .......................................... ......................... 114
THE Technical data ................................................ .................................................. 115
General ................................................. .................................................. .......................... 115

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Electronics ................................................. .................................................. 116 ....................................
Mechanical ................................................. .................................................. ..................................... 116
Environmental conditions ................................................ .................................................. .......... 117
Bluetooth module ................................................ .................................................. .................... 117
Specifications EMC IEC 60601-1-2 ........................................ ............ 118
General specifications table 201 ............................................. 118 ........................
General specifications table 202 ............................................. ........................ 119
Systems of non-life support table 204 .................................. 121
protection recommended distances between portable and mobile HF communication
devices and the device table 206 .............................. ..................................................
...................................... 122

1
2067634-131 Revision E SEER ™ 1000 9
1Introduction
This document describes the SEER 1000 ECG recorders and softwareapps SEER 1000, also
known as "systems", "device", "products" or "equipment". This manual is intended for users of
these devices.
There are three SEER 1000 ECG recorders, which differ in maximum recording time and
the color of the face;
• 24 hours (blue)
•48 hours (purple)
•7 days * (green)
* Long-term MARS ECG analysis system supports the ECG recording during a period of up to three days.
All three SEER 1000 ECG recorders are for use both in adults, but also suitable for pediatric
patients (including patients weighing less than 10 kg). Inquire please about any restrictions on the
long-term ECG analysis seusoftware operating instructions.
They can be purchased two software applications, one for the Apple iOS App and the other as a
software application for the Microsoft Windows operating system. Both applications are designed
to transmit patient data to a recorder for recording the preparation, visually examine the ECG
curves, changing the recorder settings, and start recording. The use of these apps is optional.

Introduction
10 SEER ™ 1000 2067634-131 Revision E
This chapter contains general information that is necessary for proper use of the goods and this
instruction manual. Familiarize yourself with this information before using the system.
Target group
The devices are intended for use by trained users in hospitals and medical centers, under
the direct supervision of a qualified physician.
Indication
The SEER 1000 is a recorder to ECG long-term, indicated for patients who could benefit from a
continuous long-term ECG recording. These are for example patients who complain of
palpitations, chest pain or shortness of breath, or patients who should be monitored for their
ability current heart can be evaluated.
Goal
The ECG SEER 1000 long-term recorder is designed for continuous recording of ECG data. The
recorder does not make any cardiac analysis and is intended to be used in conjunction with a
long-term ECG analysis software. The recorded data are downloaded on a PC, to be then be
analyzed and evaluated by a doctor or experienced specialist.
Contraindications
Contraindications to the use of the equipment are not known.
subject to prescription device
CAUTION
Note that in the US a national law only allows the appliance to be used by a physician or
under his order.

Introduction
2067634-131 Revision E SEER ™ 1000 11
Regulations and safety information
This section contains information on the safe use of this system and compliance with legal
requirements. Familiarize yourself with this information, and read and understand all instructions
before attempting to use this system. The system software is seen as a medical software. As
such, it was designed and built in accordance with the relevant regulations and health controls.
NOTE
Failure to follow the safety instructions is regarded as improper use of this system and
can cause injury, loss of data or void the warranty.
The meaning of the signal words
A risk is defined as a source of potential injury to a person or damage to property.
The terms "Warning", "Caution" or "Warning" are used in this manual to indicate the risk and
severity of a threat. Familiarize yourself with the following settings:
Definition of signal words
Signal word Definition
DANGER It indicates an immediate risk that, if not avoided, could result in
death or serious injury. (Not used in this instruction manual.)
NOTICE indicates a potential hazard or unsafe practices which, if not
avoided, could result in death or serious injury.
CAUTION indicates a potential hazard or unsafe practices which, if not
avoided, could result in minor or moderate injury.
ATTENTION indicates a potential hazard or unsafe practices which, if not avoided,
could result in damage to the product or other property, and loss of
data.

Introduction
12 SEER ™ 1000 2067634-131 Revision E
Safety instructions
The following safety instructions apply to the entire system. specific safety instructions can
occur in other parts of this manual.
WARNINGS
NOTICE
NO MONITORING DEVICE - The SEER 1000 is not a monitoring device and is not
suitable for monitoring the patient's clinical status.
Do not use the SEER 1000 as a monitoring device.
NOTICE
RECORDINGS OF CONFUSION - risk to health or life of a patient can arise when a
patient is assigned to the ECG recording of another, and this leads to a diagnosis
incorrectly assigned.
Be especially careful to always select the correct recording and the right patient. Between, in
case of digital management of patients where the patient ID or enter the patient ID in the
door-data to ensure that a recording is not assigned to the wrong patient.
NOTICE
ELECTROSURGERY - There is a risk of burns and damage to the patient.
When an electrosurgical instrument is used, you must disconnect the cable ECG recorder.
NOTICE
EXPLOSION HAZARD - electric sparks in the presence of certain gases can cause
explosions.
Do not use the recorder in a oxygen-rich environment, or the presence of other flammable
or explosive gases.
Make sure a patient, possibly for reasons of professional, could remain in such
environments.

Introduction
2067634-131 Revision E SEER ™ 1000 13
NOTICE
CABLE - Cables pose a strangulation risk
To avoid a potential bottleneck situation route all cables away from the patient's neck. Use
in pediatric patients short versions of the cable.
NOTICE
Conductive Materials - can result in electric shock or malfunction of the device, if the
electrodes come in contact with conductive materials.
Make sure that the conductive parts of electrodes and associated parts do not come into
contact with any other conductive parts or grounding. Make sure that there is no contact with
other conductive parts, if electrodes become loose during recording.
NOTICE
DANGER GENERAL FOR PATIENT - The information in this manual, do not replace in
any way, the information to good medical practice of patient care.
Proceed, in all circumstances, in accordance with good medical practice.
NOTICE
DANGER OF CONTAMINATION OR INFECTION - The recorder and its accessories may be
contaminated with bacteria or viruses after use.
When the recorder is contaminated in some way, observe the standard procedures for
handling contaminated objects and the following precautions:
O Wear gloves when touching the objects. O Wear gloves when touching the objects.
O Isolate the packing material and appropriate labeling. O Isolate the packing material and appropriate labeling.
O Send stained material only after consultation with the O Send stained material only after consultation with the
recipient and appropriately labeled.
O Clean the burner and the accessories after each use. O Clean the burner and the accessories after each use.
Information, are in the " Maintenance " on the page Information, are in the " Maintenance " on the page Information, are in the " Maintenance " on the page
111.

Introduction
14 SEER ™ 1000 2067634-131 Revision E
NOTICE
CHOKING HAZARD - Packaging materials are a choking hazard.
Do not leave packaging material within reach of children.
INDICATIONS OF CAUTION
CAUTION
RISK OF INFECTION - The re-use of consumables, which come into contact with the
patient present a risk of infecting other patients.
Do not use consumables (eg, electrodes) after they have already been used on a patient.
CAUTION
INFECTION RISK - Our service team is exposed to a risk of infection if parts are shipped
or products that have not been disinfected.
Disinfect the recorder and ECG cable for hygienic reasons in particular to protect
our personal assistance service, before sending them back for inspection or
maintenance.
INDICATIONS OF ATTENTION
ATTENTION
Damage to the cable - the cable can be damaged if it is bent strongly curved or
curled.
When placing and connecting the ECG cable, ensure that it can not be damaged. Never
wrap the cord around the burner. The correct handling is explained in section " Connect the wrap the cord around the burner. The correct handling is explained in section " Connect the
ECG cable to the recorder and the electrodes ", Page 46. ECG cable to the recorder and the electrodes ", Page 46.
ATTENTION
DAMAGE TO UNIT due to battery FLUID LEAK - The batteries may leak if a device is not
used for a long time.
Remove the phone's battery if it is not used for more than a week.

Introduction
2067634-131 Revision E SEER ™ 1000 15
ATTENTION
POOR QUALITY OF ECG RECORDINGS - may be of insufficient quality of ECG
recordings, if the patient is not properly prepared.
Properly prepare the patient for recording, as explained in section " Preparing for Properly prepare the patient for recording, as explained in section " Preparing for
recording "On page 39. recording "On page 39.
ATTENTION
POOR QUALITY OF ECG RECORDINGS - Damage recorders and accessories can lead
to insufficient quality of ECG recordings.
Control visually for damage to the recorder and ECG-ECG cable before applying the
recorder and the electrodes on a patient.
ATTENTION
A malfunction or damage in the unit - Changes in temperature or humidity may cause
condensation in the burner.
Wait at least two hours beyond the visible drying outside the recorder, to
use it again.
ATTENTION
MACHINE DAMAGE - On the recorder only can open the battery
compartment.
Do not apply in any way, force the recorder.
ATTENTION
ONLY WITH SAFETY ACCESSORIES APPROVED - A safe and reliable operation of
the machine is possible only when using the supplied or approved accessories.
Please follow the relevant instructions in this manual and the "Manual of spare parts and
accessories", as well as the instructions supplied with the accessories.
ATTENTION
SAFETY AND RELIABILITY ONLY WHEN MAINTENANCE IS CARRIED OUT CORRECTLY
- Proper maintenance is essential to ensure the long-term safety and reliability recorder.

Introduction
16 SEER ™ 1000 2067634-131 Revision E
Note the information in the chapter " Maintenance "On page 111. Note the information in the chapter " Maintenance "On page 111. Note the information in the chapter " Maintenance "On page 111.
ATTENTION
UNIT DAMAGE AND ACCESSORIES - Unauthorized personnel may not have the training
necessary to repair the device. If repairs are carried out by unauthorized persons, this can
result in damage to the appliance and accessories.
Send the device to check a failure or even suspect that there is to have it checked at GE
Healthcare or an authorized representative of GE Healthcare. Attach an accurate
description of the observed disturbance.
ATTENTION
DIFFICULTIES IN SEARCH PROBLEMS - The recorder and ECG cables are needed to find
the faults and repair them.
For service or repair to the unit, always send also the ECG cable used. (Not wrap the cord
around ECG recorder, as this may damage the cable).
Use a tape recorder to always the same ECG cable. Note that when multiple recorders are
available in a facility that a recorder is always in conjunction with a specific ECG cable.
Thus errors can be located and repaired faster.
ATTENTION
ENVIRONMENTAL POLLUTION - Electronic devices and accessories may contain metal
and plastic parts, which need to be eliminated at the end of its useful life, in accordance
with applicable waste regulations to prevent environmental pollution.
Dispose of the device and accessories at the end of life, the way required by local and
national regulations.
If you have questions about the disposal of this product, entr contact GE Healthcare or
an authorized GE Healthcare representative.

Introduction
2067634-131 Revision E SEER ™ 1000 17
ATTENTION
RECORDINGS OF LOSS OR INSUFFICIENT ECG SIGNAL QUALITY - It may be that
the recorder be used with unsatisfactory results if the patient does not have all the
necessary information.
It is the responsibility of the physician, give the patient the necessary information for an
evaluable ECG recording. In the section " Inform the patient "On page 40 are more evaluable ECG recording. In the section " Inform the patient "On page 40 are more evaluable ECG recording. In the section " Inform the patient "On page 40 are more
information.
ATTENTION
INTERFERENCE - electrical emissions of an electric blanket can reduce the signal quality.
Do not use the recorder with an electric blanket.
Medical Device Classification
The device is classified as follows, according to IEC 60601-1:
Medical Device Classification
Category ranking
protection against electric shock Degree Type CF, application component not protected
defibrillator
Protection against ingress of dust and
water
The recorder's protection class is IP43,
with:
4 = Protection against objects> 1 mm 3 =
Protection against splashing water
The level of security when used in the
presence of flammable mixtures and
anesthetic agents and oxygen or air or
nitrous oxide
The device is not suitable for use in the
presence of a flammable mixture of anesthetic
and air or oxygen or laughing gas.
sterilization and disinfection process
suggested by the manufacturer
Not applicable
operational continuous operation

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18 SEER ™ 1000 2067634-131 Revision E
Certification
Medical equipment
Certification with respect to electrical shock, fire and mechanical
hazards only in accordance with IEC 60601-1 CAN / USA C22.2 NO.
601.1, IEC 60601-1-2 and IEC 60601-2-47.
Accuracy of the input signal
The amplitude frequency response corresponds to the following requirements of IEC
60601-2-47 Section 51.5.9:
• In the burner, the effect of a rectangular pulse 5mV / 100 ms after the pulse does not
lead to a displacement of position zero amplitude greater than 0.1 mV in relation to the
zero line before drive. The reduction of the pulse is less than 0.3 mV / s. The excess of
the first pulse flank is less than 10%.
• Playback of all pulses of a triangular pulse sequence of 1.5 mV / 40 ms, which simulates
a next series of R-waves is within 80% to 110% reproduction of a sequence of triangular
pulse 1.5 mV / 200 ms.
Warning EMS / CEM / AF
The system was designed and tested to meet the requirements for electromagnetic compatibility
(EMC). System changes or additions to this system not expressly approved by the manufacturer
may cause EMC issues with this or other equipment.
high frequency devices may impair the use or the accuracy of the device or system. During the
installation and use of the device or system should be observed known AF sources in the
environment, including:
• radio and television stations,
• portable and mobile devices for wireless communication (cell phones, radios)
and
• ray machines ray, CT scan or MRI machines

Introduction
2067634-131 Revision E SEER ™ 1000 19
These devices also represent possible causes of interference as they may emit
higher levels of electromagnetic radiation.
NOTICE
FAILURE OF EQUIPMENT - The use of mobile phones and other devices AF in the
periphery of the system may cause unexpected or undesirable behavior.
Avoid the use of mobile phones and other devices nearby AF system.
NOTICE
Attachments or components - The addition of accessories or components to the system
or the device or system modification can lead to an increase of radiation or reduced
immunity of the device or system.
More information about EMS / CEM and AF can be obtained from the following sources:
O Reference Manual of spare parts and accessories O Reference Manual of spare parts and accessories
for your system
O Or authorized representatives GE Healthcare GE Healthcare O Or authorized representatives GE Healthcare GE Healthcare
O Annex on electromagnetic compatibility in this manual O Annex on electromagnetic compatibility in this manual
instructions.
biocompatibility
The system components described in this manual, including accessories that, when used as
prescribed, come in contact with the patient meet the biocompatibility requirements of the
relevant standards. If you have questions about this, please contact GE Healthcare or their
representatives.
Information on spare parts and accessories
Ordering information and a list of products that are approved for use with this device, are in
SEER 1000 -
Reference Manual of spare parts and accessories which are supplied with each recorder. Reference Manual of spare parts and accessories which are supplied with each recorder.

Introduction
20 SEER ™ 1000 2067634-131 Revision E
Manufacturer Responsibility
The manufacturer is only responsible for the results in terms of safety, reliability and performance
if the following conditions are met:
• assembly, extensions, adjustments, modifications or repairs are performed by
people they have been authorized to do so by GE Healthcare.
• The electrical installation of the relevant room complies with their standards.
• The system is used according to the instructions for use.
• GE Healthcare information is obtained, before connecting the equipment any devices
that are not recommended in this manual.
Information on the product and packaging
This section describes where the labels used on your device and its packaging. First the
symbols used on the labels are explained.
symbols
The following symbols can be found on the device and system packaging. To become familiar
with the meaning of these symbols, you are ensuring a safe use and disposal of the equipment.
The meaning of the symbols not listed here are the information of the original equipment
manufacturer (OEM).
Symbols are used for the transmission of warnings, precautions, prohibitions, binding or
information measures. A danger symbol on the product or packaging, with color codes indicate a
specific threat or is a warning. All hazard symbols in black and white, existing on your device or
on the packaging indicates a potential hazard and suggest a precautionary measure.
Symbol Meaning
Catalog number or part number
refers to the catalog number or the number of manufacturer part.