SEER 1000 Operating [PDF]

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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 continuing product innovation, specifications in this manual are subject to change without notice. This manual is developed and owned by GETEMED Medizin- und Informationstechnik AG (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 Company 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 designed to connect specifically to the iPod, iPhone, or iPad, 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. 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

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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

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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

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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

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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 NonIndependent 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

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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

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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

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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

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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

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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

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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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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, visually 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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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) recording, including, but not limited to, those with complaints of palpitations, 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 intended 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 order of, a physician.

Regulatory and Safety Information This section provides information about the safe use and regulatory compliance 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 medical regulations and controls. 12

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NOTE Disregarding the safety information provided in this manual is considered 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. Familiarize 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 messages may also appear elsewhere in the manual.

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WARNINGS WARNING NO MONITORING DEVICE – The SEER 1000 recorder is not a monitoring 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 medium 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 patient 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, observe 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 information, 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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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 temperature 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 “Connecting the ECG Cable to the Recorder and to the Electrodes” on page 48.

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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 preparation 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 accessories 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 operation of the device is only possible when using the supplied and approved 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. 2067634-077 Revision F

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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 repair 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 failures 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 applicable 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 Patient” on page 42 for more information. 18

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NOTICE INTERFERENCE – Electrical emissions from an electric blanket may degrade 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 electrical shocks

Type CF non-defibrillation-proof applied part.

Degree of protection against harmful ingress or water

The ingress protection classification of the recorder is IP43, whereby 4 = Protection against objects > 1 mm (0.04 inches) 3 = Protection against spraying water

Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide

Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide.

Method(s) of sterilization recommended by the manufacturer

Not applicable

Mode of operation

Continuous operation.

Certification Medical Equipment With respect to electric shock, fire, and mechanical and other specified hazards only in accordance with IEC 60601-1, CAN/USA C22.2 NO. 601.1, IEC 60601-1-2, and IEC 60601-2-47

Input Signal Reproduction Accuracy The frequency response meets the following EN IEC 60601-2-47 requirements: 2067634-077 Revision F

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

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 approved by manufacturer could cause EMC issues with this or other equipment. 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 unexpected 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 Reference Manual, or modifying the medical device or system, may result in increased EMISSIONS or decreased IMMUNITY of the device or system. 20

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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 repairs 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. Familiarity with these symbols assists in the safe use and disposal of the equipment. 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

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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 electric shock for an earth-free (floating) applied part (one intended for contact with patients) for cardiac application.

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Symbol

IP43

Description

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 connected 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 device that are not otherwise found on the label. Consult the accompanying documentation for more information about safely using this device. Non-ionizing Electromagnetic Radiation Indicates that the equipment emits elevated, potentially hazardous, 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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Symbol

+

Description

Battery Polarity This symbol indicates the position of the positive pole of the battery 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 dispose of in accordance with local, state, or country laws. Waste of Electrical and Electronic Equipment (WEEE) Indicates this equipment contains electrical or electronic components that must not be disposed of as unsorted municipal waste, but collected separately. Contact an authorized representative 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 concentration of restricted substances, the symbol contains a lowercase 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.

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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 indicated 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 Medical Device Directive 93/42/EEC. PCT (GOST-R) Mark Indicates the device or product conforms with applicable Russian 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 technical and safety requirements following testing by Technischer Überwachungsverein, (Technical Inspections Organization).

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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 recording. Female This symbol is selected in the apps for female patients. Male This symbol is selected in the apps for male patients.

   26

Delete This symbol is selected in the apps to delete a patient or technician. 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 patients or technicians.

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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 descriptions. Item

Label

Location

Description

1

Back of device

See section “Product Label” on page 28.

2

Product Package

Identifies the following information for shipping: 

Product description



Serial number



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Item

Label

3

Location

Description

Product Package

Contains handling, cautionary information, and disposal symbols.

Equipment Identification GE Healthcare and GE Healthcare distributed devices have a product label that identifies the product name, part number, manufacturing information, and unique serial number. This information is required when contacting 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 information. 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.

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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 reference 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 identifies 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. Values for production range from 00101 to 99999.

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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.

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Introduction

Service Information This section provides information pertaining to the maintenance and servicing of the system. Familiarize yourself with this information before requesting service from GE Healthcare or its authorized representatives.

Service Requirements Failure on the part of the responsible individual, hospital, or institution using 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 experts 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 assistance.

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.

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Manual Purpose This manual provides information necessary for the configuration and safe operation of this equipment in accordance with its function and intended use. It is not intended as a replacement for, but a supplement to, thorough product training. Additional manuals will be provided electronically 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 documents, and third-party product documents distributed by GE Healthcare Diagnostic Cardiology.

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Convention

Description

Bold Text

Indicates keys on the keyboard, text to enter, or hardware items such as buttons or switches on the equipment

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 between 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 release the ESC key.

Enter

Indicates that you must press the Enter or Return key on the keyboard. Do not type Enter.

Indicates that you must press the spacebar. When instructions are given for typing a precise text string with one or more spaces, the point where you must press the spacebar is indicated as: . This ensures 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 command from the literal text within the string.

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Convention

Description

>

The greater than symbol, or right angle bracket, is a concise method to indicate a sequence of menu selections. For example, the statement “From the main menu, select System > Setup > Options to open the Option Activation 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. Depending 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 essential 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 additional information that may be helpful in the configuration, the maintenance, 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

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2 2

Product Overview This chapter describes the main features of the recorder. You will be presented 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 recording. The number of channels recorded depends solely on the type of ECG cable used. The devices automatically detect pacemaker pulses as a standard feature. 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 available: 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 recorders may be used as stand-alone devices without the apps. 2067634-077 Revision F

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Product Overview

ECG recordings are transferred to the evaluation workstation using a special USB cable.

Operating Elements of the Recorder

36

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

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Event Button

This button is used to perform the following functions: Function

User Action

Switch on/off the recorder

Press and hold for more than a second until a 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 without the app

Press and release. A double beep will sound to confirm the recording has started.

Mark an event during recording

Press and release. A beep will sound to confirm the event has been recorded.

Activate wireless connectivity

Press and hold for more than three seconds until 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.

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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 Button)

Green, then fades

Contains recording

Solid yellow

Low battery

Slow flashing yellow

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

Fast flashing, green and yellow alternating

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

Hookup Guidance Light

Electrodes properly connected

Solid green

Electrodes loose or disconnected (excluding ground electrode)

Flashing yellow

If the 3-Lead cable is used, the open lead detection of the SEER 1000 recorder is disabled. Recording in process

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LED is turned off

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

Fast flashing, green and yellow alternating

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

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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 electrodes, 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 recording 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.

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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 reactions may occur.



Do not expose the recorder to water, including adverse weather conditions 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 recorder 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 activities, symptoms, and the corresponding times during the ECG recording. The header of this diary should include patient demographic data, recorder identification, and medication taken. 42

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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, palpitations,



each visit to the toilet,



medication dosage,



any strenuous activity such as running, carrying heavy items, shopping, 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 segments 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.

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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 adhesive surfaces of the electrodes.

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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

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

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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

46

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

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Electrode Placement with 3 Leads for the Recording of 3 Non-Independent ECG Channels To record 3 non-independent ECG channels, three electrodes are attached and connected to the color-coded leads.

AHA Color Coding AHA Color

IEC Color Coding

IEC Color

Location

White

Red

Right manubrial border of sternum

Black

Yellow

Right border of sternum, 7th rib

Red

Green

Left lower rib cage

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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 connecting 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 recorder as shown by a green circle in the graphic. Do not try to connect 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 connector straight off the recorder. Do not disconnect by pulling on the cable.

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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 rechargeable 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,

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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 attached 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.

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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 section “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 recording. 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 deleted 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 selecting or adding a patient and after checking the signal quality.

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See chapter 5, “Applications (Apps) – General Information”, chapter 6, “Using the Apple iOS Apps”, and chapter 7, “Using the Personal Computer App”, for more information on the apps. NOTE The recorder date/time is set during hookup using the Mobile Application 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 after 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 access 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.

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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 communication (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).

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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 after the recording has finished. Make sure the data is transferred and erased before assigning the recorder 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).

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Removing the Electrodes CAUTION RISK OF UNNECESSARY SKIN IRRITATIONS – After a long-term ECG examination, 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, refer 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 seconds. 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 information on transferring the ECG data.

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

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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 subject 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 update 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.

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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 recording.



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 wireless technology.

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Data Protection For data protection purposes, both apps employ access control using two levels of password protection. The first level is the administrator password; the second level is the ECG technician password. Setting these passwords is explained in the section “Changing the Administrator Password” 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 administration account password or manually without an app, the protection key stored on the recorder will be different from what is configured 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 generated by the recorder. In this case, wireless access is no longer possible until the data has been downloaded and deleted. Should a recorder become locked because a technician outside the control 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 “Resetting 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 administrator, 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 SUPPLIED 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 application device.



Remove any possible RF interfering devices from the vicinity of recorder and application device.

Upon switching on the recorder, the Bluetooth module remains active until the recording is started. Once the recording is started, the wireless connectivity will be deactivated. 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 technicians, 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 description 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 device, 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 recorder. GE recommends you change the passwords on first login. Be sure to use the same administrator password to connect all supported software programs (iOS App, PC App, CardioDay, and CardioRead) to the recorder. 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 password is used to secure the recorder from unauthorized access. Change the password whenever necessary, e.g., if it has been communicated 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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Using the Apple iOS App

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 passwords 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.

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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 following steps: 1.

Log in as administrator. Touch Administration in the upper right corner and enter the administrator 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 administrator 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 interface. 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 interface 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 connection. 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 Update 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 results 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 performance 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 factory 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 device, open Settings, select Bluetooth and verify that it is On. The app is password protected to avoid unintentional access to a recorder. On your first login overwrite the default password and replace it with your new password. 70

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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 administrator. You can also use the Admin ID if this has been entered 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 enabled, 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. 2067634-077 Revision F

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Patients Tab – Preparing and Starting an ECG Recording If you have prepared the recording as explained in the “Preparing the Recording” 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 demographic 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 displayed. 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 seconds to several minutes depending on the number of Bluetooth 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 recorder 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 request.

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 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 connections 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 rechargeable battery icon at the bottom left of the screen. Standard Alkaline Battery Rechargeable Battery 2067634-077 Revision F

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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 recording.

at the bottom of the screen to start the

If the battery state is not sufficient, a message is displayed and the recording 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. 80

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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 recorder’s Bluetooth module by pressing the Event Button of the recorder 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 recorder 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 onscreen 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 recorder. On your first login the user will be prompted to overwrite the default password and replace it with a new password. NOTICE UNAUTHORIZED ACCESS TO THE RECORDER – The administrator password is used to secure the recorder from unauthorized access. Change the password whenever necessary, e.g., if it has been communicated to unauthorized people. NOTE Only the administrator can create Technician IDs and reset passwords 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 following steps: 1.

Log in as administrator. Touch Administration in the upper right corner and enter the administrator 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 factory 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 recorder. On your first login the user will be prompted to overwrite the default 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 Recording” 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 enter the date or you can select day, month, and year using the and arrow keys and then use the and arrow keys to change the values.

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4.

If the patient has been previously entered into the app, doubleclick 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 seconds to several minutes depending on the number of Bluetooth 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 enter the PIN code 1234 or to confirm the PIN code displayed in order 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 connections 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 display 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. 92

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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 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 rechargeable battery icon at the bottom left of the screen.

 

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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 recording 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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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 demographic 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.

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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 recorder’s Bluetooth module by pressing the Event Button of the recorder 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 recorder 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:

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

Start



Stop



Delete SEER™ 1000

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Troubleshooting This section explains error signs and troubleshooting recommendations.

Recorder Troubleshooting Trouble Indicators

Cause

Recommendation

The Event Button LED flashes yellow once every second. An error tone sounds when you try to start the recording.

Battery power is low.

The battery is not fully charged or the wrong battery type has been inserted. Replace with new alkaline battery or NiMH rechargeable battery.

The Hookup Guidance LED flashes yellow once every second.

Electrode or ECG cable is not connected.

Connect the ECG cable or reconnect loose electrodes.

An error tone sounds when you try to start the recording.

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Trouble Indicators

Cause

Recommendation

The Event Button LED is a solid yellow.

Previous recording or patient entry has not been deleted.

To start a new recording, delete the recording and/or patient demographic data using either the Holter analysis system software or the SEER 1000 app.

The Event Button LED stops flashing green during specified recording duration.

The recording has stopped before the specified recording duration has been reached.

The recording may have been started with a low battery. Download or delete the recording and replace the battery to start a new recording. Check the unit for physical damage. If the unit is damaged, contact service.

The Event Button LED and the Hookup Guidance LED flash green and yellow alternating three times every second.

Recorder cannot be started. Self-test failed.

See section “How to Notify Service if the Recorder is Defective” on page 108.

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Troubleshooting

Application Troubleshooting Message

Recommendation

“A technician with the same identifier exists already.”

Enter a new technician identifier.

“An error occurred while connecting. You should try again.”

Try again to connect to the recorder.

“Battery level too low to start a recording.”

For the recording duration selected, the battery 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 down.”

Insert a new alkaline or a fully charged NiMH battery.

“Data could not be deleted. Please check if the SEER recorder is connected to another software.”

If the recorder is currently connected to an evaluation software via USB, e.g., to transfer a recording, wait until this data exchange is terminated and then disconnect the USB cable before you re-try to delete the data.

Data stored on recorder. Do you want to select a different recorder?

Delete the data stored on the recorder or download 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 have at least 8 characters.”

Enter a new password with at least eight characters.

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Message

Recommendation

“Recorder “SN” is no longer paired with this PC. Do you want to repeat the pairing procedure for this recorder?”

(Message from Microsoft Windows) Select “Yes”.

“Recorder is no longer paired with this device. Please repeat the pairing process for this recorder.”

(Message from Apple iOS)

The pairing procedure is executed automatically.

1. 2.

Close the app. Call up the Apple iOS Settings menu.

3.

Select the Bluetooth tab.

4. 5.

Select the “Forget this device” option. Select the recorder.

6.

Repeat the pairing process for this recorder.

“Recorder is recording. Do you want to select a different recorder?”

A recording is already running. Stop and delete 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.

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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 recording. In this case, go to the Patients tab and delete the patient manually.



If the recording is not running but the waveforms are displayed (Event Button LED shows solid green), try again to start the recording.



If the recording is not running and no waveforms 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.

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Troubleshooting

Message

Recommendation

“The protection key stored in the recorder does not match the current administrator passwo rd.”

The recorder is currently protected by a key generated from another administrator password. Use an app controlled by the correct administrator 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 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 generated by the recorder. In this case, wireless access is no longer possible until the data has been downloaded and deleted.

“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.

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Troubleshooting

Bluetooth Troubleshooting Trouble Indicators

Cause

Recommendation

Error while connecting recorder and app

Recorder and app device are either too close to or too far away from each other.

For best results, do not position the devices closer than 50 cm (approx. 20 inches) to each other or more than 10 m (approx. 11 yards) from each other.

The app device's Bluetooth connectivity is not enabled.

Verify that your device's Bluetooth connectivity is enabled.

Objects between recorder and application device affect the connection.

Remove any objects from the line of sight between recorder and application device.

RF interfering devices affect the connection.

Remove any possible RF interfering devices from the vicinity of recorder and application device.

The recorder's Bluetooth connectivity is not enabled because this is switched off after the start of a recording.

Press and hold the Event Button for approx. 3 seconds until the multi-beep indicates wireless connectivity is activated.

After starting a recording, no wireless connectivity active

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MUSE Orders Troubleshooting Trouble Indicators

Cause

Recommendation

MUSE Connection Test failure during setup. Query Orders button missing from Add Patient tab.

Improper URL.

The URL to be entered needs to be the base URL for the REST interface followed by the port number, e.g., http://192.168.0.201:8100.

Wrong HostName or IP address.

Confirm proper HostName and/or IP address of the MUSE System.

HostName to IP address lookup (DNS) not functioning.

Confirm HostName resolution / lookup is working on iOS device. Try entering the IP address of the MUSE system in URL.

Wrong IP Port used for MUSE API.

The proper listening IP PORT number of the MUSE API service (default 8100) must be included as part of URL configuration.

MUSE API service is not running.

Confirm with MUSE Administrator or GE support that the MUSE API service is configured properly and is running without errors.

User Name or Password is not a valid MUSE User.

Confirm that the configured User and Password match that of a valid MUSE User.

Other network communication fault or port blocking.

Check for other network communication faults, restrictions, and firewalls.

Improper “Site Number" in configuration.

Confirm the presence of MUSE orders with proper Site number.

No Holter Orders with OPEN order status.

Confirm the presence of MUSE orders with:

No MUSE Patient/Exam Orders displayed in Order List.

TestType=Holter Status=OPEN

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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 reason of the problem. In this case, the system messages and the respective error codes are displayed. These messages and error codes can be interpreted 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 corresponding password.

4.

Click Login. The Patients tab opens.

5.

Change to the Devices tab.

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6.

Select the recorder. If the recorder to be reset is not listed, click the Find Device option.

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.

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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.

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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 (Count of LED flashes)

Failure

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 returned to GE support for repair.

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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 ingredients: 

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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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 conductive or insulating and can affect signal quality. 

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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 happens, blot them dry with a soft, lint-free cloth.

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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 moistened 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 moistened 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 instructions 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.

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CAUTION DAMAGE TO THE EQUIPMENT – Failure to use the proper cleaning solutions 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 passing it on to another person. Only use these cleaning agents and disinfectants:

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

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.

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

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 happens, 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 moistened 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-ventilated area. Do NOT coil leadwires or cables around the device.

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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 together with the Hookup application.

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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

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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

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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)

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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

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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 CISPR 11

Group 1

The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Not applicable

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations / Flicker emissions IEC 61000-3-3

Not applicable

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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 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

 8 kV contact

 8 kV contact (electrode snaps only, direct discharge on device not possible due to pouch)  15 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electric fast transi-  2 kV for power ent / burst supply lines IEC 61000-4-4  1 kV for input / output lines

Not applicable

Not applicable (battery powered device)

Surge IEC 61000-4-5

 1 kV differential mode  2 kV common mode

Not applicable

Not applicable (battery powered device)

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

5% UT (>95% dip in UT) for 1/2 period

Not applicable

Not applicable (battery powered device)

Not applicable

Not applicable

 15 kV air

< 5% UT (>95% dip in UT) for 1 period 70% UT (30% dip in UT) for 25 periods 95% dip in UT) for 5 s

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE:

30 A/m

UT is the AC mains voltage prior to application of the test level.

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Electromagnetic immunity (conducted and radiated RF disturbances) 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 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6

3 V effective value 150 kHz to 80 MHz

3 V effective value

Portable and mobile RF devices are not used at closer than 30 cm to the device including leads

6 V effective value in the ISM bands between 0,15 MHz and 80 MHz

6 V effective value in the ISM band according to table 5, Note N)

10 V/m 80 MHz to 2,7 GHz

10 V/m

Radiated RF IEC 61000-4-3

Immunity against According to wireless RF commu- Table 9 nication devices

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The field strength of stationary radio transmitters is, as determined by an electromagnetic site survey, at all frequencies smaller than the compliance level. Interference may occur in the vicinity of equipment marked with the following symbol:

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Index

accessories, 21 biocompatibility, 21 certification, 19 classification, 19 contraindications, 12 document conventions, 32 electrode placement, 43, 44 equipment identification, 28 illustration conventions, 33 indications for use, 12 intended user, 12 label locations, 27 product, 28 manual purpose, 32 notes, 33 package information, 21 prescription device statement, 12 product label, 28

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product information, 21 product label, 28 regulatory and safety information, 12 related documents, 33 responsibility of the manufacturer, 21 safety conventions, 13 hazards, 13 information, 12 serial number format, 29 service information, 31 requirements, 31 signal reproduction, accuracy of, 19 skin preparation, 43 supplies, 21 symbols, 21 typographical conventions, 32 warranty information, 31

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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