Abilia Emfit 464000 User manual

Emfit® Epilepsy Alarm
User manual
Art. nr: 464000 464031 464052
EN 8.0

Table of contents
1. Introduction...............................................................................................................................5
1.1. About Emfit Epilepsy alarm ................................................................................................ 5
1.2. Intended purpose................................................................................................................ 5
1.3. About this document........................................................................................................... 5
2. Overview of Emfit Epilepsy Alarm ..........................................................................................6
3. Get started with Emfit Epilepsy Alarm....................................................................................8
3.1. Set up the DIP-switches before use ................................................................................... 8
3.2. Insert the batteries............................................................................................................ 10
3.3. Prepare the 5V AC External power supply (optional) ....................................................... 10
3.4. Connect the sensor, power supply and external systems ................................................ 11
3.5. Install the control unit........................................................................................................ 12
4. Use the Emfit Epilepsy Alarm ...............................................................................................13
4.1. Place the sensor under the mattress................................................................................ 13
4.2. Use the SW1 press switch................................................................................................ 13
4.3. Signal lights ...................................................................................................................... 14
4.4. Signal sounds ................................................................................................................... 15
4.5. Set sensitivity to notice tonic-clonic seizure ..................................................................... 16
5. Maintenance ............................................................................................................................18
5.1. Checks.............................................................................................................................. 18
5.2. Change batteries .............................................................................................................. 19
5.3. Cleaning ........................................................................................................................... 19
6. Troubleshooting .....................................................................................................................20
7. Transport, storage and disposal ...........................................................................................21
7.1. Transport .......................................................................................................................... 21
7.2. Storage ............................................................................................................................. 21
7.3. Disposal............................................................................................................................ 21
8. Technical specifications ........................................................................................................22
8.1. Control Unit....................................................................................................................... 22
8.2. Bed Sensor....................................................................................................................... 22
8.3. Power supply (optional) .................................................................................................... 22
8.4. Accessories ...................................................................................................................... 22
9. Important information ............................................................................................................23
9.1. Safety definitions .............................................................................................................. 23
9.2. Safety instructions before using Emfit Epilepsy Alarm ..................................................... 23
9.3. Serious incidents .............................................................................................................. 23
9.4. Conformance with requirements for medical devices....................................................... 23
9.5. Product liability ................................................................................................................. 23
Appendix – Related images ..........................................................................................................24
Appendix – X2- (AUX) Connector Pin Order................................................................................27
Appendix – Recommended distance from RF-equipment .........................................................28

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1. Introduction
1.1. About Emfit Epilepsy alarm
Emfit Epilepsy alarm 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. The control unit notifies the caregiver with a 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.
The device is not diagnostic and cannot differentiate between a tonic-clonic seizure and other fast
movements. The manufacturer cannot guarantee that the device will detect all episodes of tonic-
clonic seizure-induced body movements of the monitored person. 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. The device cannot be used to verify whether the alerted body
movement was caused by a tonic-clonic seizure
Operating environment is typically a bedroom at a care-home or at home.
NOTE: Emfit Epilepsy alarm is only intended to be used as an aid by care providers. The
product must not replace human supervision.
1.2. Intended purpose
Emfit Epilepsy alarm 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
undermattress sensor due to a tonic-clonic seizure while sleeping.
2. of the presence of the monitored person on the mattress equipped with the
undermattress bed sensor and if he or she gets up from the mattress.
Emfit Epilepsy alarm may either be used:
• solely for the task described in point 1 above.
• for the tasks described in points 1 and 2 above simultaneously.
1.3. About this document
This user manual is intended for persons that support users with using Emfit Epilepsy Alarm.
The user manual describes how to use Emfit Epilepsy Alarm in a safe way.

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2. Overview of Emfit Epilepsy Alarm
1. Control unit
2. External power supply (accessory, included in art. nr. 464052)
6. Bed sensor (L-4060 SLC or L-4060 SL)
7. Wall mounting bracket with two screws and two plugs
8. Clip for bed side attachment
Included parts
•2 AA-batteries
•Cable kit (for selected markets)
Included document
•User manual (this document)

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2.1.1. Control unit
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.
The control unit operates with 2 pcs AA size 1.5 V alkaline batteries. An external power supply is
available. In the event of a power failure, two high-quality 1.5V AA alkaline batteries can be used
as an emergency power supply. The control unit has an input connector for the bed sensor and
power supply. The device also has a connector 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, see picture) that can be used to
acknowledge a notification or as an on/off switch. The control unit has 8 DIP switches to select the
settings and a rotary switch to adjust the sensitivity of the device.
2.1.2. Bed sensor
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-movements in the body allow the device to detect the person's
presence.

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3. Get started with Emfit Epilepsy Alarm
NOTE:Always test the device before using it and when the settings are adjusted.
3.1. Set up the DIP-switches before use
Inside, you will find eight DIP switches that are used to select the desired functions (see picture).
Default factory settings Switch
Movement notification delay is 13 seconds.
1 and 2 OFF
(down)
The bed exit notification is disabled.
3 ON (up)
4 and 5 OFF
(down)
The SW1 switch acts as the On/Off switch, which means that
the device can be switched on or off by pressing the switch
for three (3) seconds.
6 OFF (down)
The notification sound is set to Very loud.
7 and 8 OFF
(down)
NOTE:
•If the wrong DIP switch settings are used, the unit will not work as expected.
•Remove the batteries and disconnect the power supply before setting up the DIP
switches to implement the new settings.
To change the settings:
1. Disconnect the power supply (if used) and all cables.
2. Open the lid by lifting the side, see image.
3. Remove the batteries.
NOTE:If the batteries and power supply are not disconnected, the
new settings will not be implemented.
4. Select the desired settings.
5. Insert the batteries.
6. Close the lid
7. Connect all cables and the power supply.

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3.1.1. Adjust the tonic-clonic seizure notification delay
Setting the time delay before the alarm is triggered.
When the device detects faster movement (between 3–20Hz), its internal timer switches on. The
device gives a notification if the movement continues for longer than the preset time. The delay can
be set to 10, 13, 16 or 20 seconds.
Choose the desired delay according to the following table. If there are problems with false alarm,
increase the time delay.
Setting the fast movements duration after
which the notification goes off
Switch 1
Switch 2
10 seconds
ON (up)
ON (up)
13 seconds (default)
OFF (down)
OFF (down)
16 seconds
ON (up)
OFF (down)
20 seconds
OFF (down)
ON (up)
3.1.2. Adjust the Bed-Exit Notification Delay
The device can be set to trigger a notification when a person leaves the bed and the system does
not notice any micro-movements.
Time delay
Switch 3
Switch 4
Switch 5
No delay
OFF (down)
OFF (down)
OFF (down)
Disabled (default)
ON (up)
OFF (down)
OFF (down)
3 min Delay
ON (up)
ON (up)
OFF (down)
6 min Delay
OFF (down)
OFF (down)
ON (up)
10 min Delay
ON (up)
OFF (down)
ON (up)
15 min Delay
OFF (down)
ON (up)
ON (up)
30 min Delay
ON (up)
ON (up)
ON (up)
3.1.3. Activate or deactivate the SW1 switch function
SW 1 switch function
Switch 6
The SW1 switch acts as the On/Off switch which means that the device
can be switched on or off by pressing the switch for three (3) seconds.
OFF (down)
The SW1 switch does not act as the On/Off switch. The device is always
on when it is connected to the power supply or when the batteries are in.
ON (up)
3.1.4. Adjust the notification sound volume
NOTE:Adjusting the volume may lead to the notification sound not being heard.
The sound signal must only be used when care persons are near the control unit. The volume can
be set to loud, normal, quiet, or mute.
The sound signal stops when the reset button is pressed and when a seizure is over. If the user
leaves the bed, the sound signal stops when the user returns to the bed or when the SW1 switch is
pressed.
Level
Switch 7
Switch 8
Very loud
OFF (down)
OFF (down)
Normal
ON (up)
OFF (down)
Quiet
OFF (down)
ON (up)
Mute
ON (up)
ON (up)

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3.2. Insert the batteries
NOTE: Do not use any rechargeable batteries or lithium-ion batteries.
1. Open the lid lifting it from
one side.
2. Insert two high-quality AA
size 1.5V alkaline batteries
into the device following the
polarity symbols at the bottom
of the device.
3.3. Prepare the 5V AC External power supply (optional)
WARNING:If an external force breaks the AC adapter and parts remain in the socket, it can
result in electric shock.
1. Remove the plastic cover.
2. Select a suitable plug from
the four alternatives
3. Plug in the plug and make
sure that it is not loose.
NOTE:Do not use any power supply other than that provided by Abilia.

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3.4. Connect the sensor, power supply and external systems
NOTE:
•The notification sound may be absent if the sensor or its cable is incorrectly positioned or
damaged.
•The sensor or the sensor cable must not be stretched or cut.
Connect the bed sensor, power supply (if used), and any cables to external systems (such as
forwarding to nurse call systems or forwarding systems).
For a description of the X2 socket pin order, see Appendix – X2- (AUX) Connector Pin Order on
page 27.
1. Connect the cable from
the Emfit bed sensor to the
X3 socket.
2. Connect the cable to the
external system in the X2
socket.
3. Connect the power supply
(if selected) to the X1 socket.

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3.5. Install the control unit
NOTE:Do not install the device near or on top of another device. If this cannot be avoided, the
user must make sure that the device functions correctly.
3.5.1. Install the control unit on the wall
3.5.2. Install the control unit with a bed side clip
Press the control unit down on the bed side clip.
1. Fix the mounting
bracket onto the wall.
2. Slide the control unit
onto the wall mounting
bracket until you hear a
click.

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4. Use the Emfit Epilepsy Alarm
NOTE:
•Do not let the device get wet.
•Do not use the device in strong electromagnetic fields.
•Test the device before using it and when the settings are adjusted.
•Check the condition of the sensor and cables at least once a week and replace them if
necessary.
•Check the entire system at least once a month.
•The equipment is not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide.
4.1. Place the sensor under the mattress.
NOTE:
•The notification sound may be absent if the sensor or its cable is incorrectly positioned or
damaged.
•The sensor or the sensor cable must not be stretched or cut.
•Pets can cause false notifications if they walk or lie on a bed fitted with the device.
•Adjust the device sensitivity if the sensor is reinstalled or if the user or sensor is replaced.
•Always place the bed sensor under the mattress or mattress topper, never just under the
sheet. The bed sensor must not come in direct contact with a person.
•The bed sensor must not be used with a pressure care mattress that is adjusted using a
compressor pump, the mattress may interfere with the sensor's performance.
1. Place the bed sensor across the bed, under the mattress at approximately chest
height (see picture).
2. Fix the sensor to the bed bottom mattress using the provided double sided tape to
prevent the bed sensor from moving. The tape will not leave marks and will come
off as a whole if removed.
3. If you are using the bed sensor with a spring mattress, place the bed sensor
between the mattress and the mattress topper.
a. Place a hard board (plastic or hardwood 2-3 mm thick) under the sensor
to avoid damaging the sensor.
b. Set the switch for sensitivity to 4.
4.2. Use the SW1 press switch
NOTE:If you press the SW1 switch for too long, you might accidentally
switch off the device.
The SW1 switch (see picture) can be used in four ways.
4.2.1. Use SW1 as an acknowledgement switch
The notification sound (if activated) can be muted by pressing the SW1 switch
shortly. The device will make a "beep-beep" sound. The fast movement
notification sound will stop when the movement stops.
In the event of absence in bed notification, the sound signal stops after about 40 seconds when the
user returns to the bed.
4.2.2. Use SW1 as an ON/OFF switch
The SW1 switch acts as the on/off switch if this function is activated (DIP switch 6 is down). Press
the SW1 switch for three (3) seconds in order to activate or deactivate the control unit. When the
control unit is switched on, you will hear a beep and the blue LED light will start to flash. When the
device is switched off, you will hear a "beep-beep-boop" (high-high-low) sound. The blue LED light
will go off.

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4.2.3. Use SW1 as a bed exit alarm bypass switch
The bed exit alarm can be deactivated if the user wants to leave the bed without triggering an
alarm. This means that the user can leave the bed without any time limit. The time delay for the
bed exit alarm is not activated again until the user returns to the bed and then leaves it.
When the bed exit alarm is activated through DIP switch 4 and you want to deactivate the alarm,
the SW1 switch must be pressed before the time delay runs out. A beep sound is heard when the
alarm is deactivated. The SW1 switch can also be pressed before the user leaves the bed to
deactivate the alarm.
When the SW1 switch is pressed, the user has 20 seconds to leave the bed. If not, the alarm is
activated again.
4.2.4. Use SW1 as a bed exit alarm ”presence/absence” sensitivity switch
The SW1 switch can be used to launch automatic calibration for presence and absence sensitivity.
See chapter 4.5. Calibrating the “presence / absence” sensitivity
4.3. Signal lights
The LED lights provide information about the status of the product.
4.3.1. Green – Presence
Light flashes every second time
compared to blue light.
A person is on the bed or other movement is being
made.
Light flashes the same speed as blue
light.
A person has been on the bed for 60 seconds and the
device has become activated.
Light flashes rapidly.
Fast-paced movement on the bed detected
Light is off.
No one is on the bed.
4.3.2. Blue – Device on/standby
Light is off.
Device is switched off
Light flashes slowly.
Device is switched on.
Light flashes rapidly a few times.
Device triggers a notification.
4.3.3. Red – Malfunction
Light is flashing the same speed as
blue light
Bed sensor is disconnected or defective. Signal alarm
sounds after 10 seconds and then every 45 seconds.
There is also an alarm sent through the X2 connector
after 30 seconds and then every 30 minutes.
Light is flashing every fourth time
compared to blue light.
Batteries are empty. Replace batteries.

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4.4. Signal sounds
There are two types of signal sounds.
Alarm signals, that are long and loud, are used to notify about fast movements and bed exit. Alarm
signals can be muted using the DIP switches (see section 3.1.4 Adjust the notification sound
volume).
Information signals, that are short and quieter than alarm signals, are used as feedback to the
user. Information signals tell the user when the device is turned on or off or when alarm signal is
acknowledged. Possible malfunctions of the equipment (disconnected bed sensor, empty batteries)
and feedback about calibration of the sensor are also notified with information signals. Information
signals can’t be muted.
Alarm signals are high priority signals that will overrule information signals if both signals activate
simultaneously.
4.4.1. Alarm signals
Two high and low “BEEPS” in a loop.
Fast movements alarm goes off.
Three high and low “BEEPS” in a loop.
Bed exit alarm goes off.
4.4.2. Information signals
Short, high “BEEP”.
SW1 is pressed and device turns on.
Short, low “BEEP”.
SW1 is pressed and device is turned off.
Short, low “BEEP” x 2.
SW1 has been pressed once and alarm signal is
acknowledged.
Short, high “BEEP” x 3 and short low “BEEP”
x 3.
Sensor is disconnected or broken. Information
signal sounds after 10 seconds of disconnection
and then every 45 seconds.
Short, high “BEEP”, short “LOW” beep.
Batteries are empty. Replace batteries.
Short, high “BU-BEEP” x 3.
Sensitivity calibration has started / successful
calibration.
Short, low “BEEP” (after calibration).
Sensitivity too low.
Short, low “BEEP” (after calibration) x 2.
Sensitivity too high.

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4.5. Set sensitivity to notice tonic-clonic seizure
NOTE:
•The sensitivity of the product must be adjusted according to the
user’s weight
•Adjust the sensitivity of the device every time the sensor is re-
installed and if the user or the sensor changes.
•Test the device before using it and when the settings are
adjusted.
The sensitivity to notice fast movements caused by tonic-clonic seizure can be adjusted with the
10-position rotary switch inside. The factory default setting is 3. Increasing sensitivity may lead to
false notifications while decreasing sensitivity may lead to the notification not becoming activated
when needed.
If you feel that sensitivity is not good enough, simply adjust higher step by step. Or, if you feel it is
too sensitive causing false notifications, simply drop the setting lower step by step.
Person weight
Switch position (in parenthesis if false alarms
occur)
>75 kg
1 (0)
50-75 kg
2 (1)
35-50 kg
3 (2 or 1)
25-35 kg
4 or 5 (3 or 2)
15-25 kg
6 or 7 (5 or 4)
<15 kg
8 or 9 (7 or 6)
4.5.1. Calibrate the ”presence/absence” sensitivity
NOTE:Always calibrate if there are changes, such as a new bed or mattress, or if someone else
is going to use the sensor.
If you use the bed-exit (absence) notification, the sensitivity to determine that person is in or out of
the bed is adjusted in calibration mode. Increasing sensitivity can lead to false alarms while
decreasing sensitivity can lead to the alarm not being activated when needed.
The person to be monitored should be in bed and lying still (not moving or talking) for at least one
(1) minute until green light starts to blink the same speed as blue light. The monitor (control unit)
should be placed on a table, clipped on bed, or mounted on wall. Sensor should be in correct
position under mattress.
Start calibration by pressing the SW1 switch (picture 21) three (3) times. You will hear 3 low and
high tones (bu-beep, bu-beep, bu-beep). The calibration takes 18 seconds. If calibration is
successful, the confirmation sound will be the same 3 low and high tones (bubeep, bu-beep,
bubeep).

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4.5.2. Error messages and how to handle them
One (1) long beep - Device has not detected strong enough micro movement signal and has
reached an adjustment limit. Device might not work optimally. Is the sensor positioned correctly in
the bed and device was not in error -state (red led was not blinking)? If not: Correct the problem
and re-try calibration. If yes: Adjust the rotary switch up 2 notches and re-try auto adjustment.
Two (2) long beeps - Device has detected too strong signal and has reached an adjustment limit.
Device might not work optimally. Was person laying still during the calibration period? Re-try
calibration again and see if second time would be successful. If second time gives same error
sound, adjust the rotary switch down 2 notches and do the calibration again. You can always return
sensitivity to factory default. First press SW1 three (3) times and soon after hearing the three
sounds, press SW1 again 3 times. That interrupts adjustment and device returns to factory setting.

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5. Maintenance
5.1. Checks
5.1.1. Weekly checks
1. Check the condition of the cables
2. Check the position of the bed sensor under the mattress. The correct position is at the
chest height of the user and across the bed.
5.1.2. Start-up and monthly checks
To ensure faultless performance, conduct the following tests at least once a month and whenever
the device is re-installed.
Testing the tonic-clonic seizure notification
1. Make fast-paced movements (e.g. tapping the mattress repeatedly around the bed sensor).
2. The green light should start flashing when you tap the mattress.
3. The device should trigger a notification after the preset delay time has passed (10, 13, 16
or 20 seconds).
Testing the absence notification sensitivity
1. Check that the function is activated. If it is not, set DIP switch 5 to OFF position. Make sure
that the control unit is on (blue LED flashes slowly).
NOTE:To activate the changes, the batteries must be removed and the power supply
disconnected.
2. To test the sensitivity of the sensor, have a person lie on the bed completely still and
without talking. Wait at least 1–2 minutes. The control unit should immediately register
micro movements in the body and the green light should flash slowly every second time the
blue light flashes. The green light flashes constantly if a person is in the bed. The control
unit is activated when movements or micro movements have been registered for 40
seconds and the green light starts flashing in the same pace as the blue light.
3. If the device does not register presence of a person (green light does not flash), see section
6 Troubleshooting. If the green light still does not light up, increase the sensitivity by turning
the rotary switch up gradually until the green light lights up. If the green LED lights up when
no one is on the bed, turn the rotary switch down gradually until the green light is no longer
on.
4. Ask the person in the bed to leave the bed. A notification is triggered after the pre-set delay
time (provided that no one has touched sensor, bed or cables). If a notification is not
triggered and the green light continues to flash, see section 6 Troubleshooting).

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5.2. Change batteries
NOTE:Do not use any rechargeable batteries or lithium-ion batteries.
Unplug the power supply to test the batteries. When it is time to replace the batteries, the red LED
starts flashing slowly. The device makes a beep sound every 1.5 hour and X2 notifies every three
hours.
1. Disconnect the power
supply and all cables.
2. Open the lid by lifting the
side.
3. Lift the old batteries at the
positive terminal (+) and
remove them.
4. Insert two 1.5 V AA alkaline
batteries. Make sure that the
poles are placed correctly
according to the marking.
Estimated battery life is 6 months when using high quality alkaline batteries with 2800 mAh
capacity (2 pcs). Estimation is based on the device being on 50% of time (shut down 50% of time)
and of that 50% of time there is someone in bed 75% of that time, there are two notifications per
day and sound notification is on 30 seconds each time.
5.3. Cleaning
NOTE:
•Do not let the device get wet.
•Unplug the power supply before cleaning
Always disconnect the external power supply and remove nurse call cable (if used) from connector
X2 before cleaning the device. You can wipe the bed sensor and cables, control unit and external
power supply with a damp cloth, neutral cleaning product or mild disinfectant. Dry all parts well
after cleaning.

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6. Troubleshooting
Ensure that the device is properly installed. Test the device carefully every time its settings are
adjusted.
Problem
Solution
The device triggers a notification, but
the nurse call system does not.
Ensure that the external wireless transmitter or other
system’s connection cable is connected to the X2
connector.
Check the battery of the external wireless transmitter.
Notification sound is inaudible.
Check the volume.
The device triggers a notification even
if there is no unusual movement.
Check the condition, installation, and position of the bed
sensor.
Check that the sensitivity setting of the sensor is not too
high. The green light should not be on if no one is on the
bed.
The device may interpret normal movements (scratching,
rocking, etc.) as a seizure. Adjust the delay time longer if
necessary. Some people are restless before they fall
asleep, and this might cause false notifications. Try
switching the device on only after the person has fallen
asleep.
If the bed exit alarm is enabled (DIP switch 3 in DOWN
position) and sensitivity is not set high enough, alarm may
trigger. Either disable alarm (DIP switch 3 in UP position) or
see section 15.
The green light is on even if no one is
on the bed.
Ensure that the bed sensor and its cables are not affected
by external movement and remove any distractions.
Check the condition of the bed sensor and its cables. Faulty
sensor or cable may cause distractions so that the green
light is on all the time.
Adjust sensitivity.
The device does not trigger a
notification, and the green light is not
on even if someone is on the bed.
Check the condition of the bed sensor and its cables.
Check the sensitivity of the device by having someone lie
on the bed completely still. The green light should be on.