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EC-Declaration of Conformity

(Directives 93/42/EEC and 2004/108/EC)

Manufacturer:

emcotrade GmbH

Address:

Esselbachstrasse 27

D-75438 Knittlingen

Germany

Product specification:

URIPHON® wireless 2

Class:

IIb

We declare that the above-listed medicine product conforms to the relevant
provisions of the EC Council Directive

93/42/EEC and 2004/108/EC

Adopted standards:

EN 55011:2009+A1: 2010

EN 60601-1-2:2007
EN 60601-1-11:2011
EN 606011:2006/A11:2011
2011/65/EU
2006/66/EC
IEC 62321:2013
ETSI EN 300220

Knittlingen, July 3

rd

, 2017

Peter G. Meiser
Managing Director

The original certificates can be inspected at the offices of emcotrade GmbH.

Keep this manual for the entire life of the product!

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Содержание wireless 2

Страница 1: ...1 Wireless alarm device for the monitoring of bedwetting enuresis Instructions for use ...

Страница 2: ...2 ...

Страница 3: ...her than a complete pair being required In addition any transmitter can be paired with any receiver Absorbent pads which are fastened to underwear in use are available for the new version too They can be used freely in any underwear and also offer continuous use without a drying phase They can be re inserted immediately after an alarm It is not necessary to use special underpants Thanks to the new...

Страница 4: ...A type batteries for the Receiver 1 CR2450 button battery for the Transmitter power supply unit storage bag detailed manual brochure Bedwetting the latest information for a common problem Fig 1 Outer packaging Device serial numbers Receiver serial number Transmitter serial number ...

Страница 5: ...5 Delivery of Fig 2 Delivery Instructions for use 3 contact pads with spare adhesive points Power Supply unit Transmitter Receiver Button battery CR2450 2 type AA batteries ...

Страница 6: ... Functions and function indicators Controls Transmitter Fig 3 Transmitter front Clips to attach the Transmitter to the underpants Press studs to fix the contact pads Pairing Button Serial number of the Transmitter ...

Страница 7: ...arm duration the capacity of the batteries extends for several months LED display for the operating mode of the Receiver No display The device is running on battery and the battery is charged Red LED flashes The Receiver batteries have to be replaced Green LED Device running on power supply Beeper Label e g for name or room number LED indicators for the Transmitter and pairing mode Only orange col...

Страница 8: ...battery compartment Fig 7 Receiver back with open battery compartment Battery compartment cover Serial number of the Receiver Battery compartment for two 1 5V AA batteries Connection jack for operating the receiver with mains supply 100 240V AC ...

Страница 9: ...e Fig 9 Power supply plug with cable Press studs for the connection of the contact pads with the Transmitter adhesive points for fixing the contact pads to the underpants Power supply plug for connection to 100 240V AC Plug to connect to the receiver power supply ...

Страница 10: ...eral weeks before they have to be replaced Preparation of the Receiver The Receiver can be powered using the power supply unit fig 9 type SYS1421 0605 W2E and also with two commercially available 1 5V AA batteries 1 Battery operation Open the battery compartment on the Receiver To do this slide the lid of the battery compartment outwards in the direction of the arrow Fig 10a Insert two 1 5 V AA ba...

Страница 11: ...can be switched on or off at your choice If vibration alarm is switched on and an alarm is being triggered by the wet sensor additionally to the acoustic signal of the receiver the alarm is also being signalized by vibration directly at the body of the patient Important note The vibration alarm consumes significantly more battery power than the radio signal of the transmitter As long as the connec...

Страница 12: ...ch and take off the enclosure cover Fig 11a and 11b With sliding switch next to the battery select vibration alarm On or Off Fig 11c Push the CR2450 button battery into the battery holder Important When inserting make sure the battery polarity is correct Fig 11d Afterwards fit back the cover and close the cabinet again The Transmitter is now ready for use Fig 11a Opening of the Transmitter emclosu...

Страница 13: ...d then release You will hear a short double beep and both LED displays light up for the Transmitter orange drop icon and red battery symbol Fig 5 Now briefly press the Pairing button on the Transmitter Fig 4 You will hear another short double beep which acknowledges and confirms the pairing on the Transmitter Both LED displays go out Now Transmitter and Receiver can communicate Vibration Alarm On ...

Страница 14: ...ceed as follows Press the pairing button on the Transmitter For as long as you hold the button the two LED displays on the Receiver orange drop icon and red battery icon are lit Transmitter and receiver are connected Please keep in mind that it may take about 1 2 seconds when you press the pairing button until the LEDs light up This is due to the fact that the Transmitter in order to save power co...

Страница 15: ...ith the device 3 units are placed in the pants so that the centre of the contact pad is placed in front of the urethral opening The double sided adhesive points supplied are used for fastening to the pants Fasten a dry contact pad to the pants Connect the press studs of the contact pad with the press stud of the Transmitter Fig 12a Connecting Transmitter and contact pads Fig 12b Connecting Transmi...

Страница 16: ...extremely important in the success of the treatment In this way the patient learns to immediately stop the urine to stand up and go to the toilet An increasingly loud alarm signal sounds The LED display for the Transmitter fig 5 orange drop symbol alarm lights up As long as an electrical connection takes place through the urine on the contact pad this loud alarm sounds continuously and with short ...

Страница 17: ...contact pad must be worn Once the connection to the Transmitter is restored the system is ready to go again The patient can go back to sleep Especially at the beginning of therapy depending on the age of the wearer the procedure may require more or less assistance from parents or helpers Summary of the Receiver displays fig 5 a LED display for the Transmitter s operating mode Only the orange colou...

Страница 18: ...Never squeeze the pads but after thorough rinsing lay them flat between two dry cloths and press out any moisture with the cloth Then hang to dry For reuse the pads must be absolutely dry because any moisture can immediately trigger the alarm To fully extend the life of the contact pads it is recommended that they are washed after use for a few hours in a container filled with water The Transmitte...

Страница 19: ...le bed liner is the LiSSI sensor matte also available as a SET Important note Since the transmitter of is not in direct contact with the patient s body when using a ring mat it is recommended to switch off the vibrating alarm on the transmitter This significantly increases the lifetime of the transmitter battery Please refer to the instruction manual for the LiSSI sensor matte for the further proc...

Страница 20: ...eivers A further receiver must only be registered paired to the transmitter see section Pairing of the Transmitter to the Receiver page 13 All receivers paired with the transmitter give an acoustic signal in the event of an alarm simultaneously The alarm sounds however have to be switched off individually for each receiver see section Stopping the Alarm page 17 For answers to frequently asked ques...

Страница 21: ...cleaning of the devices should only be done using a damp cloth Always grasp the power supply unit by the handle Never pull on the cable when disconnecting from the power supply Connect the power supply unit only to an easily accessible socket 230 V 50 Hz located in the vicinity of where the Receiver is being installed In the event that you need to quickly disconnect the device from the power suppl...

Страница 22: ...TB170615954 EN 55011 2009 A1 2010 EN 60601 1 2 2007 gem EMC Directive 2004 108 EC Certificate No TB170716196 EN 60601 1 11 2011 EN 60601 1 2006 A11 2011 gem MDD Directive 93 42 EEC Certificate No TB170615945 2011 65 EU 2006 66 EC IEC 62321 2013 Nominal voltage 3V DC voltage battery power supply The manufacturer guarantees the safety and function of the unit only if Upgrades resetting modifications...

Страница 23: ...cine product conforms to the relevant provisions of the EC Council Directive 93 42 EEC and 2004 108 EC Adopted standards EN 55011 2009 A1 2010 EN 60601 1 2 2007 EN 60601 1 11 2011 EN 606011 2006 A11 2011 2011 65 EU 2006 66 EC IEC 62321 2013 ETSI EN 300220 Knittlingen July 3rd 2017 Peter G Meiser Managing Director The original certificates can be inspected at the offices of emcotrade GmbH Keep this...

Страница 24: ...A Receiver 1mA Alarm s power consumption Transmitter without vibration alarm 30mA with vibration alarm 70mA Receiver 150mA Average life span Transmitter approx 6 weeks of batteries Receiver approx 6 weeks Acoustic performance of signal transmitter 92db 10cm Operating conditions Temperature 0 C 45 C Air humidity 20 80 Transport and storage Temperature 20 C 45 C Air humidity 20 80 Additional accesso...

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Страница 28: ...28 Disposal Do not dispose of electronic equipment in the household waste Before disposing of the devices remove the batteries Return used batteries to a battery collection point September 2017 ...

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