Abilia Emfit 464000 Manuale utente

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

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.

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)

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.

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.

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)

13 seconds (default)

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)

Disabled (default)

ON (up)

OFF (down)

3 min Delay

ON (up)

OFF (down)

6 min Delay

OFF (down)

ON (up)

10 min Delay

ON (up)

OFF (down)

ON (up)

15 min Delay

OFF (down)

ON (up)

30 min Delay

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)

Normal

ON (up)

OFF (down)

Quiet

OFF (down)

ON (up)

Mute

ON (up)

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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