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

2

3
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

4
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

5
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.

6
2. Symbols used in these instructions for use
The following instructions are designed to ensure the personal safety of the user and
protect this device or any device connected to it from damage. These instructions use
symbols to draw the user's attention to the instructions at hand. The symbols act as safety
and warning signs. The symbols and their explanations are as follows:
If the instructions are not adhered to, the situation may lead to a death or
serious personal injury (in these instructions for use). ATTENTION - consult
accompanying documents (i.e. these instructions for use)
Means that the section contains important information for the user (in these
instructions for use).
Indicates the maximum use and storage temperature of the bed sensor.
When led next to this is blinking it indicates person is in bed (in the control
unit)
When led next to this is blinking it indicates product is in stand-by mode (in
the control unit).
Non-ionizing radiation (in these instructions for use, chapter
Electromagnetic conditions).
Symbol of European Waste Electrical and Electronic Equipment Directive
(WEEE Directive) 2002/96/ EC on waste electrical and electronic
equipment (in these instructions for use and on bed sensor).
Indicates that the product is in compliance with the European directive
2002/95/EC on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (commonly referred to as the Restriction
of Hazardous Substances Directive or RoHS).
Indicates manufacturer’s name and address (in the control unit and bed
sensor).
Indicates positioning of battery cell. + is positive terminal and - is negative
terminal (in the control unit).
Indicates polarity of d.c. power connector (In the external power supply).
Indicates alternating current (in the external power supply).
Indicates direct current (in the external power supply).
Indicates that product meets safety requirements specified in IEC 61140 for
Class II equipment (In the external power supply).
Product is for indoor use only (in the external power supply).
Product is UL Demko certified (in the external power supply).
Product is China SJ/T 11363-2006 certified (in the external power supply).

7
Product is UL certified (in the external power supply).
Indicates that the product conforms with the relevant requirements of the
Medical Device Directive 93/42/EEC.
Product is VCCI certified (in the external power supply).
Product is UKRSepro certified (in the external power supply).
Product is GOST-R certified (in the external power supply).
Product is C-TICK certified (in the external power supply).
Product is China RoHS 30 certified (in the external power supply).
Product is BSMI certified (in the external power supply).
Product is SIQ certified (in the external power supply).
Product is IRAM certified (in the external power supply).
Product is CCC certified (in the external power supply).
Product is CPSQ certified (in the external power supply).
Product is PSE to J60950 certified (in the external power supply).

8
3. Introduction
These instructions for use describe the use of the Emfit MM, Tonic-Clonic Seizure
Monitor. The version number and details can be found in chapter 23. Technical
specifications.
Use the device only in the ambient conditions specified by the manufacturer. For
detailed information, refer to Technical Specifications in these instructions for use.
Follow all instructions provided in this document concerning the installation, use and
cleaning of the device.
Based on the intended use, point 1) of section 3.2 below, the Emfit Tonic-Clonic
Seizure Monitor is a medical device as defined in the Medical Device Directive
93/42/EEC. Based on the nature of point 2) regarding the intended use, the device is
not defined as a medical device (Directive 93/42/EEC, Article 1(2), subparagraph a).
The device is a Class I medical device in accordance with the Medical Device
Directive 93/42/EEC and carries the CE marking accordingly.
3.1 Product description
Emfit Tonic-Clonic Seizure Monitor (later “product”) is a movement monitor that is used to
detect and notify tonic-clonic seizures.
The product consists of a bed sensor located under the mattress and a control unit where
the bed sensor is connected. Control unit should be placed on a table, clipped on bed or
mounted on wall.
The control unit notifies caregiver by flashing led and sound (unless muted) and/or
transfers a notification via external system e.g. a nurse call system or a personal
emergency phone.
Operating environment is typically bedroom at care-home or home.
3.2 Intended use
The product is intended to be used to assist in sensory monitoring and to notify the
caregiver
1) of the body movements of a person lying on a mattress equipped with the under-
mattress sensor due to a tonic-clonic seizure while sleeping.
2) of the presence of the monitored person on the mattress equipped with the under-
mattress bed sensor and if he or she gets up from the mattress.
The device may either be used
solely for the task described in point 1) above,
for the tasks described in points 1) and 2) above simultaneously.
NOTE 1
The manufacturer cannot guarantee that the device will detect all episodes of tonic-clonic
seizure-induced body movements of the monitored person.
NOTE 2
The device may trigger a false body movement notification, especially if the person lying
on the mattress fitted with the under-mattress bed sensor is awake.

9
NOTE 3
The device cannot be used to verify whether the alerted body movement was caused by a
tonic-clonic seizure. The occurrence of a tonic-clonic epileptic seizure can be verified,
among other things, against electroencephalogram (EEG) data interpreted by a healthcare
professional. The product cannot replace an EEG recording system.
NOTE 4
Always ensure the suitability of the device - particularly for small children - by conducting a
test run. There are no weight or age restrictions for the use of the device.
3.3 Intended user and operator
The intended user of the product is the monitored person.
The intended operator is the caregiver of the user. The operator needs to be adult who
fully understands instructions and limitations of use mentioned in these instructions for
use. Otherwise no special skills or knowledge is needed for the operator.
3.4 Liability of the manufacturer
Abilia is liable to ensure the safety, reliability and performance of the device, provided that:
the device is installed, used and cleaned in accordance with the instructions in these
instructions for use
any changes to the product, maintenance and repairs are conducted by a person
trained by Abilia or its representative
any spare parts or accessories used have been approved by Abilia.
3.5 About these instructions for use
Read all warnings and reminders in these instructions for use with care to avoid any
hazardous situations and damage.

10
4. Package contents
•A control unit (D-1090-2G) (picture 1)
•A bed sensor (L-4060SL or L-4060SLC) (picture 6)
•Two pieces 3M double-sided tape to fix the sensor (picture 26)
•A wall mounting bracket with two screws and two plugs (picture 7)
•Clip for bed side attachment (picture 8)
•These instructions for use
•Two AA size 1.5 V alkaline batteries
•External power supply (This part is not included unless it has been ordered as a
spare part) (see chapter Technical Specifications for details) (picture 2)
5. General
5.1 Control unit (picture 1)
The control unit emits a notification via dry-contact output and by sound (unless muted)
when the sensor detects fast-paced movement (frequency 3–20Hz) in the bed for the
duration of the preset time (10, 13, 16 or 20 sec.).
The control unit operates with 2 pcs AA size 1.5 V alkaline batteries. An external power
supply is available. Do not use any power supply other than that provided by Abilia. (see
chapter Technical Specifications for details) (picture 2). In the event of a power failure, two
high-quality 1.5V AA alkaline batteries can be used as an emergency power supply. Do
not use any rechargeable batteries or lithiumion batteries! Rechargeable or lithium-ion
batteries carry the risk of melting, ruining the device and causing possible danger to the
user.
The control unit has an input connector for the bed sensor (X3) and power supply (X1).
The device also has a connector (X2) to transfer the notification via an external system
e.g. a nurse call system or a personal emergency phone.
Next to the input connector, there is a push button (SW1) that can be used to acknowledge
a notification or as an on/off switch. (picture 3)
The control unit has 8 DIP switches (picture 4) to select the settings and a rotary switch to
adjust the sensitivity of the device. (picture 5)
5.2 Bed sensor (picture 6)
The bed sensor produces a millivolt alternating current when detecting movement. The
control unit calculates the frequency and scale of the movement from this signal and, on
this basis, detects possible tonic-clonic seizure. Micro-movement from heartbeat allow the
device to detect the person's presence.