Abilia 464000 Manual
Summary of 464000
Page 1
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. M a n u al.
Page 2
2.
Page 3: Table Of Contents
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: .......
Page 4
4 16. Calibrating the “presence / absence” sensitivity .......................................................... 20 16.1 doing calibration ................................................................................................... 20 16.2 error messages and how to handle them .................
Page 5
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...
Page 6
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 ac...
Page 7
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 g...
Page 8: 3. Introduction
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,...
Page 9
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 c...
Page 10: 4. Package Contents
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 i...
Page 11
11 6. Setting up the dip switches open the lid of the control unit by lifting it from the side (picture 9). Inside, you will find eight dip switches that are used to select the desired functions (picture 4). Remember to select the desired settings using the dip switches before using the device. The ...
Page 12
12 6.2 setting the bed-exit notification delay the device can be set to trigger notification when person leaves the bed and 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) 3mi...
Page 13
13 7. Inserting batteries and battery service life disconnect the device from the power supply and remove nurse call cable (if used) from connector x2 before opening the lid. Product operates with 2 pcs high quality aa size 1.5 v alkaline batteries (operating voltage 2x1.5v = 3v). Install and remove...
Page 14
14 8. 5v ac external power supply (optional) set up the power supply in the following manner: remove the plastic cover (if applicable). (picture 23) select a suitable plug from the four alternatives. (picture 24) plug in the plug and ensure that it is not loose. (picture 25) the control unit has bee...
Page 15: 9. Connectors And Cables
15 9. Connectors and cables connector symbols can be found at the bottom of the control unit. (picture 3) vx1 connector for an external power supply. Only use globtek inc. Power supply (see chapter technical specifications for details) which can be obtained as an original accessory from abilia. X2 a...
Page 16
16 11. Installation of the bed sensor place the bed sensor across the bed, under the mattress at approximately chest height. (picture 12) to prevent the bed sensor from moving, fix the sensor to the bed bottom or mattress using the double sided tape provided or e.G. Cable ties (picture 26). The tape...
Page 17
17 12. Sw1 press switch (picture 21) 12.1 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...
Page 18
18 13. Signal lights (picture 22) 13.1 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 f...
Page 19: 14. Signal Sounds
19 14. 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 chapter 6.4 adjusting the notification sound volume). Information signals, that are short and...
Page 20: 16. C
20 15. Setting sensitivity to notice tonic-clonic seizure the sensitivity to notice fast movements caused by tonic-clonic seizure can be adjusted with the 10-position rotary switch inside (see picture 5). The factory default setting is 3. Use following table to make a pre-adjustment per person weigh...
Page 21: 17. Checks
21 16.2 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 blinki...
Page 22: 18. Troubleshooting
22 (10 –20 seconds depending on the position of dip switches 1 and 2). The green light should start flashing when you tap the mattress. See also chapter 15 setting sensitivity to notice tonic-clonic seizure. 18. Troubleshooting ensure that the device is properly installed. Test the device carefully ...
Page 23: 19. Cleaning
23 19. Cleaning you can wipe the bed sensor and cables, control unit and external power supply with a damp cloth, neutral cleaning product or mild disinfectant. Always disconnect the external power supply and remove nurse call cable (if used) from connector x2 before cleaning the device. Dry all par...
Page 24
24 this guarantee does not cover transport costs and risks associated with transport of your product to and from abilia. This guarantee does not cover: a) periodic maintenance and repair or parts replacement due to wear and tear. Notice! Emfit bed sensor wears and tears significantly faster when ins...
Page 25
25 caused downtime, loss of user time or business interruption inaccuracy of output from the product or associated products. This applies to loss and damages under any legal theory, including negligence and other torts, breach of contract, express or implied warranty, and strict liability (even wher...
Page 26
26 23. Technical specifications equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Equipment is for continuous operation. 23.1 control unit model: d-1090-2g (t63v1.3.2) operating voltage: 3v dc with batteries / 5v dc with ex...
Page 27
27 23.3 external power supply manufacturer: globtek inc. Model: gtm41076-0605 (wr9qa1200l9pnmnk2813) or gtm41060-1505 (wr9qa3000lcp-n-mnk) input voltage: 100-240 v input current: input frequency: 50 - 60 hz watts: 6.0 w / 15 w output voltage: 5 vdc output current: 1.2 a / 3.0 a electrical safety cla...
Page 28
28 24. Electromagnetic conditions system specification: - d-1090-2g monitor - l-4060sl or l-4060slc bed sensor - globtek external power supply (see chapter technical specifications for details) cable specification: - power cable (non-shielded) max. Length 2 m - sensor cable (shielded) max. Length 3 ...
Page 29
29 guidance and manufacturer’s declaration – electromagnetic immunity the emfit tonic-clonic seizure monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Immunity test iec 60601...
Page 30
30 guidance and manufacturer’s declaration – electromagnetic immunity immunity test iec 60601 test level compliance level electromagnetic environment – guidance conducted rf iec 61000-4-6 3 vrms 150 khz to 80 mhz 3 v 150 khz to 80 mhz portable and mobile rf communications equipment should be used no...
Page 31: 25. Manufacturer
31 recommended separation distances between portable and mobile rf communications equipment and the emfit tonic-clonic seizure monitor. The emfit tonic-clonic seizure monitor is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled. The customer or the u...
Page 32
32 26. Appendix - related pictures.
Page 33
33.
Page 34
34.
Page 35
35.
Page 36
36 464000,464031_manual-emfit-tonic-clonic-seizure-monitor_en_revf1.Docx dec 2017.