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Table of Contents
Summary of Contents for Abilia Emfit Epilepsy Alarm
- Page 1 Manual ® 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.
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Page 3: Table Of Contents
Table of Contents 1. Important safety precautions ..................5 Important information and limitations for use. Read before use......5 Unintended adjustment of control unit settings: ............5 2. Symbols used in these instructions for use ..............6 3. Introduction ........................8 Product description .................... - Page 4 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 ..................
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Page 5: Important Safety Precautions
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. -
Page 6: Symbols Used In These Instructions For Use
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. - Page 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).
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Page 8: Introduction
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. -
Page 9: Intended User And Operator
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 ... -
Page 10: Package Contents
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. -
Page 11: Setting Up The Dip Switches
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. -
Page 12: Setting The Bed-Exit Notification Delay
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) -
Page 13: Inserting Batteries And Battery Service Life
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). -
Page 14: Ac External Power Supply (Optional)
8. 5V AC External power supply (optional) Set up the power supply in the following manner: Remove the plastic cover (if Select a suitable plug from Plug in the plug and ensure applicable). (picture 23) the four alternatives. that it is not loose. (picture (picture 24) The control unit has been designed and tested to be used with the Globtek inc. -
Page 15: Connectors And Cables
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 AUX Connector to connect the device to a nurse call system, a personal emergency phone or an external wireless transmitter. -
Page 16: Installation Of The Bed Sensor
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. -
Page 17: Sw1 Press Switch (Picture 21)
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 beep and the blue LED light will start to flash. -
Page 18: Signal Lights (Picture 22)
13. Signal lights (picture 22) 13.1 Green – Presence Light flashes every second time A person is on the bed or other movement is compared to blue light. being made. Light flashes the same speed as blue A person has been on the bed for 60 seconds light. -
Page 19: Signal Sounds
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). -
Page 20: Setting Sensitivity To Notice Tonic-Clonic Seizure
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 weight BUT adjust it if needed either up or down. -
Page 21: Error Messages And How To Handle Them
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 blinking)? If not: Correct the problem and re-try calibration. -
Page 22: Troubleshooting
(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 every time its settings are adjusted. -
Page 23: Cleaning
22.1 Your guarantee By this Guarantee, Abilia guarantees the product to be free from defects in materials and workmanship at the date of original purchase for a period of two (2) years from that date. If within the guarantee period the product is determined to be defective (at the date of original purchase) due to improper materials or workmanship, Abilia will, without charge for labour or parts, repair or (at Abilia’s discretion) replace the product or its defective parts... -
Page 24: Exclusions And Limitations
If this exclusion is not permitted or fully permitted by applicable law, Abilia excludes or limits its warranties only to the maximum extent permitted by applicable law. Any warranty that cannot be fully excluded will be limited (as far as permitted by applicable law) to the duration of this Guarantee. -
Page 25: Your Legal Rights Reserved
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 where Abilia has been advised of the possibility of such damages). -
Page 26: Technical Specifications
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 external power supply Input and output Power supply, AUX and bed sensor connectors:... -
Page 27: External Power Supply
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: <0.6 A RMS MAX 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 class: Class II... -
Page 28: Electromagnetic Conditions
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 m Note! RF communications equipment can effect medical electrical equipment! Guidance and manufacturer’s declaration –... - Page 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 Compliance Electromagnetic environment...
- Page 30 Guidance and manufacturer’s declaration – electromagnetic immunity Electromagnetic environment – guidance Immunity test IEC 60601 Compliance test level level Portable and mobile RF communications equipment should be used no closer to any part of the The Emfit Tonic-Clonic Seizure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Page 31: Manufacturer
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 25. Manufacturer Abilia AB Box 92 191 22 Sollenuna, Sweden Phone: +46 8 594 694 00 Email: info@abilia.se... -
Page 32: Appendix - Related Pictures
26. Appendix - Related pictures... - Page 36 464000,464031_Manual-Emfit-Tonic-Clonic-Seizure-Monitor_EN_RevF1.docx Dec 2017...
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