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Declaration of Conformity

We, Vendlet ApS hereby declare that the devices mentioned below comply with the

Medical Device Regulation (EU) 2017/745.

Legal manufacturer

Vendlet ApS, Egelund 33, 6200 Aabenraa, DK

Product

Product no. and name

VENDLET Basic

UDI-DI:

05714038001056

Designation

VENDLET Basic is an electromechanical turning aid.

Classification, rule

Class I acc. to rule 1 and 13 of annex VIII in (EU)

2017/745.

The product is tested

according to the standard

EN 60601-2-52:2010 Medical electrical equipment –

Part 2-52: Particular requirements for basic safety and

essential performance of medical beds

This declaration of conformity is valid from the date of signature.

Aabenraa, 23.05.2019

Peter Maindal

Director

Содержание 05714038001056

Страница 1: ...VALUE IN CARING MANUAL BASIC...

Страница 2: ...5714038001056 Designation VENDLET Basic is an electromechanical turning aid Classification rule Class I acc to rule 1 and 13 of annex VIII in EU 2017 745 The product is tested according to the standar...

Страница 3: ...must be followed Vendlet ApS shall not be liable should the VENDLET Basic be used modified or assembled in a way that is not described in this manual This manual is divided into three parts Part 1 con...

Страница 4: ...17 Slide sheet 17 Turning sheet 18 Attaching the turning sheet before use 18 What should I do if the turning sheet is rolled askew on the bars 18 EVACUATION 19 Evacuation via the foot end of the bed...

Страница 5: ...GUIDE LOCATION 28 Connecting the control unit 28 DISMOUNTING STORAGE AND REMOUNTING 30 Dismounting 30 Storage 30 Remounting 30 PART 3 Technical manual MAINTENANCE CHECK 30 Annual check 30 Mechanical...

Страница 6: ...il itative effort The risk assessment should evaluate the clients physical cog nitive and palliative resources The risk assessment must be available by the bed and must be updated on a regular basis V...

Страница 7: ...colours on the hand control buttons Press and hold the individual buttons long enough to obtain the desired operation the motors will stop when the button is released Likewise you may stop an activate...

Страница 8: ...this Always keep focus on the client when using VENDLET Basic If the client has long and loose hanging hair the hair could in some situations be rolled onto the bar Therefore long loose hair should b...

Страница 9: ...sured that there is no entrapment hazard due to extra compression at the edge of the mattress When alternating air mattresses are used it should be possi ble to inflate the mattress to a firm state be...

Страница 10: ...s product is washable 0 50 This product must be stored between 0 and 50 C 20 90 This product must be stored between 20 and 90 humidity at 30 C Keep dry when stored Rev Revision no of the label Hand co...

Страница 11: ...supine position to lying on his her right side 1 Turn VENDLET Basic on by double clicking the button Press the button to slacken the turning sheet 7 The client now lies on his her right side 8 Press t...

Страница 12: ...ntact with the client 1 2 Do the same at the foot end 3 Turn VENDLET Basic on by double clicking the button 4 Press the or button on the hand control to drag the client to the side towards you 5 When...

Страница 13: ...sheet on to the bar whilst guiding the sheet to the upper end of the bar 3 1 Lower the bars if they are raised 2 Turn VENDLET Basic on by double clicking the button 3 Stand next to the headboard and p...

Страница 14: ...client onto his her side 3 3 Place the sling along the back of the client and make sure that the sling is centered and correctly placed in ac cordance with the instructions of the sling manufacturer...

Страница 15: ...ing until it locks in both corner posts 3 4 Press the button to wind the turning sheet onto the blue bar The VENDLET system now turns the client Hold your hands on the client s shoulder and hip to pro...

Страница 16: ...oes not have a negative im pact on the pressure relieving properties of the mattresses To prevent interference with the function of alternating air mattresses the turning sheet must be sufficiently sl...

Страница 17: ...sten the velcro straps around the mattress support frame It is important that the straps are fastened around the frame under the mattress and not around the bed frame as this will prevent the back thi...

Страница 18: ...he bars begin at the head end of the bed and work your way down to the foot end 3 The turning sheet must always be placed OVER the bars to prevent fingers hair etc of the client from getting caught un...

Страница 19: ...wer the bar on the evacuation side 2 Cut the turning sheet between mattress and the bar Pull the bed occupant to the side of the bed and evacuate 2 Remove the old turning sheet from the bar facing the...

Страница 20: ...he bars are lifted Yes No 3 Are the nylon straps attached to the bed frame and all the support bars Yes No 4 Is the condition of the turning sheet sound and does the sheet run over the bars Yes No 5 I...

Страница 21: ...plugged in and guided in such a manner that there is no apparent strain to the interface between the cable and its connection for instance between cable and control box It is furthermore also recomme...

Страница 22: ...ne or both bars do es not turn when the client is lying in bed Is the turning sheet running under the bars The sheet must be over the bars Are all plugs properly connected on the control unit The hand...

Страница 23: ...the boxes Check the packaging and contents for signs of damage and contact the distributor in case of obvious damage Parts list 1 unit Blue side complete 1 unit Red side complete 1 unit Suspension bra...

Страница 24: ...s and the side rail on both sides of the mattress Likewise it is important that the mattress guides are suitable for the mattress and will hold the mattress in place Use up to two 15 mm spacers if nec...

Страница 25: ...bed 2 Since VENDLET Basic is always mounted on beds it is impor tant to consider the whole solution You should always check the safe working load SWL of the bed and ensure that the combined weight of...

Страница 26: ...the height of the mat tress The height can be adjusted up to 7 7 cm The height adjust ment has 7 possible positions 1 Make sure that the surface of the bed is flat and hori zontal 2 If the mattress is...

Страница 27: ...other locations with free space 1 Place the suspension bracket in an appropriate location on the base of the bed Use cable ties 1 2 The suspension bracket is now placed correctly 3 Attach the power co...

Страница 28: ...equipment are jammed or otherwise damaged when the bed is in use Keep bed components and accessories at least 30 cm away from heated surfaces and direct sunlight Attaching the sheets Please refer to...

Страница 29: ...ing signs of wear Do you see any exposed wires Do both bars slacken and tighten the sheet Does the timer activate when the button is pushed twice within 2 seconds Does the timer turn off after 90 seco...

Страница 30: ...mounting fixtures for signs of damage Check the functioning of all buttons and whether the green diode is illuminated when the system is active Check all plugs cables and relief cables Check the stop...

Страница 31: ...ther bar is not working then the hand control or the control unit is defective Replace the hand control If this does not solve the problem replace the control unit Motor malfunction Replace the motor...

Страница 32: ...g time Approx 10 hours Recharging during storage First recharge of the battery must be no later than 12 months after produc tion date stated on the label Hereaf ter the battery must be recharged at le...

Страница 33: ...ring transportation at low temperatures the motors in the bars might work irregularly until they have been warmed up to normal room temper ature Disposal Do not discard VENDLET Basic with general hous...

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