MyDiagnostick 1001R User manual

MyDiagnostick 1001R - Device Manual
UI0003-001
FINAL
Revision 1
Page 1 of 10
MyDiagnostick 1001R
Device Manual

MyDiagnostick 1001R - Device Manual
UI0003-001
FINAL
Revision 1
Page 2 of 10
Table of Contents
1INTRODUCTION...............................................................................3
1.1 Intended use................................................................................................................... 3
1.2 Software ......................................................................................................................... 3
1.3 Regulatory information.................................................................................................... 3
1.4 Warnings ........................................................................................................................ 3
2PACKAGING ....................................................................................4
2.1 Packaging symbols......................................................................................................... 4
3DEVICE DESCRIPTION....................................................................5
3.1 Device label symbols...................................................................................................... 5
3.2 Visible signals................................................................................................................. 5
3.3 Audible signals ............................................................................................................... 6
3.4 Handles .......................................................................................................................... 6
3.5 Computer interface......................................................................................................... 6
4INFORMATION FOR HEALTH CARE PROFESSIONALS...............7
4.1 ECG recording................................................................................................................ 7
4.2 ECG recording errors...................................................................................................... 7
4.3 ECG storage................................................................................................................... 7
4.4 Charging the device batteries ......................................................................................... 7
4.5 Preparing the device for first use .................................................................................... 7
5INFORMATION FOR PATIENTS......................................................8
5.1 ECG recording................................................................................................................ 8
5.2 ECG recording errors...................................................................................................... 8
6MAINTENANCE, SERVICE AND WARRANTY ................................9
6.1.1 Maintenance................................................................................................................... 9
6.1.2 Service ........................................................................................................................... 9
6.1.3 Limited warranty ............................................................................................................. 9
7TECHNICAL SPECIFICATIONS.....................................................10

MyDiagnostick 1001R - Device Manual
UI0003-001
FINAL
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1 Introduction
1.1 Intended use
The MyDiagnostick 1001R assists qualified medical personnel in diagnosing Atrial Fibrillation (AF).
1.2 Software
Use the appropriate MyDiagnostick software to configure and interrogate the device. Software is
available from the MyDiagnostick website (www.mydiagnostick.com).
1.3 Regulatory information
Manufacturer
Applied Biomedical Systems
Oxfordlaan 55
6229 EV Maastricht
The Netherlands
Internet: www.ab-sys.eu
Tel: [phone]
Sales and Support
MyDiagnostick Medical BV
Oxfordlaan 55
6229 EV Maastricht
The Netherlands
Internet: www.mydiagnostick.com
Tel: [phone]
1.4 Warnings
The doctor may make a wrong diagnosis for a patient if the device was used by multiple persons
between interrogations.

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2 Packaging
2.1 Packaging symbols
Symbol
Explanation
The device is compliant with European Union regulations regarding medical
devices (NB 0344).
Read the manual before operating the device.
The packaging can and should be recycled.
Identifies the location of the manufacturer information.
The product has to be recycled as an electrical appliance.
Identifies the location of the device serial number.

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3 Device Description
3.1 Device label symbols
Symbol
Explanation
The device is compliant with European Union regulations regarding medical
devices (NB 0344).
Read the manual before using the device to obtain best results.
The device can be connected to a computer via USB.
Identifies the location of the manufacturer information.
The device meets the safety requirements for Type BF Applied Parts (EN 60601).
The product has to be recycled as an electrical appliance.
Water splashing from any direction has no harmful effect (EN 60529).
3.2 Visible signals
The MyDiagnostick 1001R has 7 LEDs (Light Emitting Diode) to indicate device status, ECG (elec-
trocardiogram) recording progress and AF (Atrial Fibrillation) detection status.
LED
Explanation
Power (yellow)
This LED is ON continuously during ECG recording. If the recording is completed
successfully this LED is turned OFF. If the recording has failed, this LED will
BLINK until the device is deactivated.
When the device is connected to a computer and the batteries are being charged
this LED will BLINK. When the device is connected to a computer and the
batteries are fully charged this LED is ON continuously.
Progress (4x, yellow)
When recording an ECG these LEDs show the progress of the recording.
No AF Detected (green)
ECG recording was completed successfully and AF was not detected.
AF Detected (red)
ECG recording was completed successfully and AF was detected.

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3.3 Audible signals
The MyDiagnostick 1001R emits audible signals to indicate ECG (electrocardiogram) recording
status.
Signal
Explanation
1x short
Recording Start.
The device emits a single short beep when the device activates and starts an
ECG recording.
2x short
Recording End.
The device emits two short beeps when ECG recording has been completed
successfully.
1x long
Error.
The device emits a single long beep when an error has occurred.
3.4 Handles
The MyDiagnostick 1001R has metal handles at both ends that serve as electrodes for ECG recor-
ding.
3.5 Computer interface
The MyDiagnostick 1001R has a USB connecter (type Mini B) at one end to connect the device to
a computer.

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4 Information for Health Care Professionals
4.1 ECG recording
When the patient grabs the device handles with both hands (one hand per handle), the device acti-
vates automatically, emits 1 short beep and starts ECG recording. The Power LED is continuously
ON during ECG recording and the Progress LEDs indicate the progress of the recording. The
rightmost Progress LED will flash at the detection of a heartbeat.
When ECG recording is successful, the device emits 2 short beeps. The AF Detected LED is
continuouslyON if AF was detected during ECGrecording. The No AF Detected LED is continuously
ON if AF was not detected during ECG recording.
The device deactivates when the patient releases the device handles and at least 5 seconds have
passed since the end of ECG recording.
Notes
1. ECG recording is not possible if the device is connected to a computer.
2. The device will only start an ECG recording if the device is in the deactivated state when the
patient grabs the device handles.
3. Recorded ECGs and detection results can be retrieved from the device using the appropriate
MyDiagnostick software.
4. The rightmost Progress LED will only flash when a heartbeat is detected if the device is confi-
gured to do so (this is the default).
5. The AF Detected LED will only be switched ON if the device is configured to do so (this is the
default). If this function is disabled, the No AF Detected LED will always be switched ON at the
end of a successful ECG recording. The correct detection result will however still be stored with
the recorded ECG.
4.2 ECG recording errors
The device monitors the signal quality during ECG recording. If an error occurs, the device emits 1
long beep and the Power LED starts blinking.
4.3 ECG storage
The device has a storage capacity of 140 ECG recordings. When the ECG storage is full, the device
will overwrite previous recordings in the following order:
1. recordings during which an error has occurred
2. recordings with no AF detection
3. recordings with AF detection
In each category the device will overwrite the oldest recording first.
4.4 Charging the device batteries
The device batteries can be charged by connecting the device to a USB power source (for example
a powered USB port of a computer).
The Power LED will blink during battery charging. Charging is complete when the Power LED is
continuously ON.
4.5 Preparing the device for first use
Before making thefirstrecording with the device, the user shouldusethe device with the appropriate
MyDiagnostick software to ensure that the device clock is set correctly.

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5 Information for Patients
If a patient is to use the device for a prolonged period of time, it is recommended to hand the device
to the patient in the designated patient package. Symbolic instructions for use are printed on the
package as depicted below. The exact symbols and format may depend on the package type.
5.1 ECG recording
1. Assume a comfortable position and relax to obtain the best results. It is recommended that the
forearms rest comfortably on a table.
2. Grab the MyDiagnostick device handles as indicated (but do not squeeze). The device will
activate (1 short beep) and startrecording. TheyellowLEDs showthe progress of the recording.
3. Wait until the MyDiagnostick signals the end of the recording (2 short beeps). Either the green
LED or the red LED will light to indicate the detection result.
4. Release the device handles and wait until the device deactivates.
5.2 ECG recording errors
The MyDiagnostick signals a recording error with 1 long beep.
1. Release the device handles until the device deactivates and try again.

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6 Maintenance, Service and Warranty
6.1.1 Maintenance
The user can clean the device with a damp cloth. The damp cloth may contain a mild soap solution
or alcohol (≤ 70%).
The user should charge the device batteries regularly.
6.1.2 Service
The MyDiagnostick 1001R does not contain any serviceable parts and cannot be opened.
The expected battery life at intensive use is estimated at 5 to 10 years.
6.1.3 Limited warranty
The warranty period is 2years. The warranty only applies to failures that are the result of manufactu-
ring faults and/or material defects.

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FINAL
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7 Technical Specifications
Mechanical
Length 260 mm
Diameter 22 mm
Weight 180 g
Electrical
Batteries 2x NiMH 1.2V 2000 mAh rechargeable (not replaceable)
Charge time (from depleted state) max. 10 hours
Battery longevity min. 500 recordings of 60-70 s at full charge
Computer connection USB 2.0 Full Speed
Power consumption max. 300 mA (charging, via USB connector)
Safety type BF (EN 60601)
Environment
Temperature (operating) +1 oC to +40 oC
Temperature (non-operating) -10 oC to +50 oC
Relative humidity (operating) 10% to 90%
Barometric pressure normal atmospheric pressure ranges
Water resistance IPX4 (EN 60529)
Functional
ECG storage capacity 140 recordings of 60-70 s
AF detection method R–R interval dispersion during 60 seconds
AF detection sensitivity min. 90% (as a result of adjusted ROC in detection)
AF detection specificity min. 95%
Miscellaneous
Classification class 2A (93/42/EEC)