Abilia Emfit Epilepsy Alarm User manual

Rev F1 EN
Emfit®Tonic-Clonic Seizure Monitor
Art.no 464000, 464031
Note! The device must not be used if an operational failure of the device might lead to a
delay in getting the appropriate treatment or medication for the patient, which could put the
patients life at risk.
Manual

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Table of Contents
1. Important safety precautions.........................................................................................5
1.1 Important information and limitations for use. Read before use..............................5
1.2 Unintended adjustment of control unit settings:......................................................5
2. Symbols used in these instructions for use ...................................................................6
3. Introduction ...................................................................................................................8
3.1 Product description.................................................................................................8
3.2 Intended use...........................................................................................................8
3.3 Intended user and operator ....................................................................................9
3.4 Liability of the manufacturer....................................................................................9
3.5 About these instructions for use..............................................................................9
4. Package contents........................................................................................................10
5. General .......................................................................................................................10
5.1 Control unit (picture 1)..........................................................................................10
5.2 Bed sensor (picture 6) ..........................................................................................10
6. Setting up the DIP switches ........................................................................................11
6.1 Adjusting the tonic-clonic seizure notification delay (switches 1 & 2)....................11
6.2 Setting the Bed-Exit Notification Delay.................................................................12
6.3 SW 1 switch function (switch 6)............................................................................12
6.4 Adjusting the notification sound volume (switches 7 and 8)..................................12
7. Inserting batteries and battery service life...................................................................13
8. 5V AC External power supply (optional)......................................................................14
9. Connectors and cables................................................................................................15
9.1 X2 (AUX) Connector Pin Order (picture 16)..........................................................15
10. Installation of the control unit.......................................................................................15
10.1 With wall mounting bracket...................................................................................15
10.2 With bed side clip..................................................................................................15
10.3 On table................................................................................................................15
11. Installation of the bed sensor ......................................................................................16
12. SW1 press switch (picture 21).....................................................................................17
12.1 ON/OFF switch.....................................................................................................17
12.2 Acknowledgement switch .....................................................................................17
12.3 Bed exit alarm bypass switch ...............................................................................17
12.4 Bed exit alarm “presence / absence” sensitivity switch.........................................17
13. Signal lights (picture 22)..............................................................................................18
13.1 Green –Presence.................................................................................................18
13.2 Blue –Device on/standby.....................................................................................18
13.3 Red –Malfunction.................................................................................................18
14. Signal sounds..............................................................................................................19
14.1 Alarm signals........................................................................................................19
14.2 Information signals................................................................................................19
15. Setting sensitivity to notice tonic-clonic seizure...........................................................20

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16. Calibrating the “presence / absence” sensitivity ..........................................................20
16.1 Doing calibration...................................................................................................20
16.2 Error messages and how to handle them .............................................................21
17. Checks........................................................................................................................21
17.1 Weekly checks......................................................................................................21
17.2 Start-up and monthly checks ................................................................................21
18. Troubleshooting...........................................................................................................22
19. Cleaning......................................................................................................................23
20. Disposal of the device after use ..................................................................................23
21. Declaration of conformity (EU) ....................................................................................23
22. Abilia limited warranty statement.................................................................................23
22.1 Your guarantee.....................................................................................................23
22.2 Terms ...................................................................................................................23
22.3 Exclusions and limitations.....................................................................................24
22.4 Your legal rights reserved.....................................................................................25
23. Technical specifications ..............................................................................................26
23.1 Control unit ...........................................................................................................26
23.2 Sensor..................................................................................................................26
23.3 External Power Supply .........................................................................................27
23.4 Ambient conditions ...............................................................................................27
23.5 Product class........................................................................................................27
24. Electromagnetic conditions .........................................................................................28
25. Manufacturer...............................................................................................................31
26. Appendix - Related pictures........................................................................................32

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1. Important safety precautions
1.1 Important information and limitations for use. Read before use.
- Must not be used in situations where a delay in the arrival of appropriate medical care, could
lead to a potentially life-threatening situation.
- This device is designed only to be used as an aid for a caregiver.
- Pets can cause false notifications or prevent a notification when needed if they walk or lie on a
bed fitted with this device.
- Do not use this device for any purpose other than that specified by the manufacturer.
- Do not connect the device to any other devices other than those specified by the manufacturer.
- Do not try to repair the device yourself.
- No maintenance of the product is allowed during use.
- Do not move or transport the device during use. If the bed equipped with the device needs to
be moved remember to unplug all cables and turn off power. Fix the control unit to the bed with
bed-side attachment clip to prevent it from moving.
- This product is for indoor use only.
- The device is designed to be used in the electromagnetic environment and conditions specified
on chapter Electromagnetic conditions.
- The client or user of the device must ensure that it is only used in the specified ambient
conditions.
- Do not install this device near or on top of another device. However, if this cannot be avoided,
the user must ensure that the device functions in the normal manner.
- Do not use X1, X2 or X3 connectors for any purpose other than that specified by the
manufacturer. Do not connect the connectors to e.g. telecommunications or local area
networks.
- If this device is used with a pressure care mattress filled using a compression pump, the device
may not function normally in some cases.
- Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or
with oxygen or nitrous oxide.
- Do not let the device get wet.
- Remove the batteries when the device is not in use or when it is stored for an extended period.
Alkaline batteries may become selfdischarged, start leaking and contaminate the device.
- Do not use any rechargeable batteries or lithium-ion batteries! Rechargeable or lithium-ion
batteries carry the risk of melting, ruining the device and causing possible danger to the user.
- The device is not diagnostic and cannot differentiate between a tonic-clonic seizure and other
fast movements.
- When removing the power supply from the socket, ensure that the plug part is not left in the
socket. If the plug part is left in the socket, touching or trying to remove it carries the risk of an
electric shock.
- Keep device cords out of the reach of children (risk of strangulation). Use protective cord
covers or cable ties to securely attach and hide cords to prevent strangulation. Keep cords as
short as possible and secure them so that they are out of reach of children.
1.2 Unintended adjustment of control unit settings:
- Adjusting the volume may lead to the notification sound not being heard.
- Increasing sensitivity may lead to false notifications while decreasing sensitivity may lead to the
notification not becoming activated when needed.
- Incorrect positioning of the DIP switches may interfere with the normal operation of the device.
- Pressing the ON/OFF/Reset (SW1) press switch for too long will switch off the device.