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Declaration of Conformity

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

Device:

Product no. and name

6200000 VENDLET Basic

UDI-DI:

05714038001056

Basic UDI-DI:

05714038001049EU

Description:

Electromechanical turning aid for handling and turning patients

in bed.

Classification, rule:

Class I acc. to rule 1 and 13 of annex VIII in (EU) 2017/745.

The product complies with the

following standards:

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

Particular requirements for basic safety and essential perfor-

mance of medical beds

60601-1-2:2015 Medical electrical equipment. General require-

ments for basic safety and essential performance - Collateral

Standard: Electromagnetic disturbances - Requirements and test

EN 60529+A1:2002 Degree of protection provided by enclosures

(IP Code) - Washability

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

Aabenraa, 29.10.2020

Peter Maindal

Director

Содержание 6200000

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

Страница 2: ...acc to rule 1 and 13 of annex VIII in EU 2017 745 The product complies with the following standards EN 60601 2 52 2010 Medical electrical equipment Part 2 52 Particular requirements for basic safety and essential perfor mance of medical beds 60601 1 2 2015 Medical electrical equipment General require ments for basic safety and essential performance Collateral Standard Electromagnetic disturbances ...

Страница 3: ...owed 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 contains general information that is useful to everyone responsible for the purchasing examination use assembly and maintenance of the VENDLET Basic Part 2 is a user manual containing information about the oper atio...

Страница 4: ...E 10 IN THE EVENT OF AN INCIDENT 10 SYMBOLS 11 PART 1 General information PART 2 User manual OPERATION 12 How to use VENDLET Basic 12 Turning 12 Moving from one side of the bed to the other 13 Repositioning the client up in the bed 14 Applying a sling 15 Prone position 16 Side rail 17 Using VENDLET Basic in combination with bed functionality 17 Pressure relieving mattresses 17 Incontinence 17 Urin...

Страница 5: ...ST 33 DISMOUNTING STORAGE AND REMOUNTING 34 PART 3 Technical manual Turning sheet 19 Attaching the turning sheet before use 19 What should I do if the turning sheet is rolled askew on the bars 19 Changing the turning sheet on an occupied bed 20 EVACUATION 21 Evacuation via the foot end of the bed 21 Evacuation via the side of the bed 21 DAILY MAINTENANCE 22 Daily inspections 22 Cleaning and washin...

Страница 6: ...eets 35 Functional tests 35 Replacements of parts 35 TROUBLESHOOTING TECHNICIANS 36 TECHNICAL DATA 37 Battery backup 37 Recharging during storage 37 LED functionality 37 Buzzer functionality 37 Power consumption 37 ESSENTIAL PERFORMANCE 38 ENVIRONMENTAL CONDITIONS AND DISPOSAL 38 Environmental conditions 38 Disposal 38 ...

Страница 7: ... professional evaluate that the client is able to take part in the moving and handling procedures e g by operating the hand control this can be a part of the rehabilita tive effort The risk assessment should evaluate the clients physical cognitive and palliative resources The risk assessment must be available by the bed and must be updated on a regular basis Vendlet cannot be held responsible for ...

Страница 8: ...ns The colour coding on the bars relates to the 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 activated function by clicking the VENDLET Basic hand control If there is an acoustic alarm reset the system by simultaneously press ing the two top buttons on ...

Страница 9: ...ar Therefore long loose hair should be collect ed before moving and handling the client Be aware that the client does not get too close to the edge of the bed as there is a risk of falling out of the bed Do not use VENDLET Basic if the bars can not be elevated properly Lowering the bed to a very low position may leave the corner post close to the floor Consequently you should not place your feet u...

Страница 10: ...extra compression at the edge of the mattress When alternating air mattresses are used it should be possible to inflate the mattress to a firm state before VENDLET Basic is operated Soft mattresses will increase the friction against the mattress and create an uneven base which will be uncomforta ble for the client when VENDLET Basic is operated If the client changes mattress the VENDLET installati...

Страница 11: ... only be used 10 of the time After 2 min of continuous use it requires 18 min rest Max 200W 80 sec 100W 40sec 25 C In continuous use at 25 C 200 W can be supplied for 80 sec then the power consumption will be reduced to 100 W for 40 sec 0 50 This product must be stored between 0 and 50 C 5 40 C This product must be used between 5 and 40 C 20 90 This product must be stored between 20 and 90 humidit...

Страница 12: ... slacken the turning sheet by pressing the or button before raising the bar Should the turning sheet be too loose on one side you can tighten the sheet by pressing simultaneously or simultaneously Always keep focus on the client when using VENDLET Remember to leave the hand control on the outside of the bed before leaving the client How to use VENDLET Basic Turning VENDLET Basic may be used to tur...

Страница 13: ...er a better work posture for example in connection with examinations train ing care tasks dressing etc Moving the client to the edge also improves the contact with the client 2 Do the same at the head end 1 5 When your work is done press the or button to reposition the client to the middle of the bed 6 Press the and button to slacken the sheet before the client is left unattended in the bed 4 2 3 ...

Страница 14: ... 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 press the button to slacken the turning sheet on the blue bar 4 1 4 Gently guide the turning sheet to the upper end of the blue bar while pressing the button to pull the client to the side of the bed 5 Stop when the ...

Страница 15: ...g along the back of the client and make sure that the sling is centred and correctly placed in accordance with the instructions of the sling manufacturer 3 4 Use the VENDLET turning function to move the client onto his her back again 6 Place all straps in such a way that they are ready to be placed on the lifting beam of the hoist 4 5 6 5 Free the straps on the opposite side Watch a video on how t...

Страница 16: ...le and that there is room for breathing 3 4 6 To return to a supine position raise the red bar and press the button to wind the turning sheet onto the red bar The VENDLET now turns the client to supine position 7 Press the and buttons to slacken the sheet before the client is left unattended in the bed 5 Prone position VENDLET Basic can also be used to turn a client to a prone position 1 Place the...

Страница 17: ...side rail by the foot board Route the tube out be tween the corner post and the side rail support bars Be careful to avoid squeezing the tube Using VENDLET Basic in combination with bed functionality VENDLET Basic does not interfere with the functionality of the bed Slacken the turning sheet sufficiently before raising the back thigh and or foot part of the bed Under normal circumstances the bed s...

Страница 18: ...ppery side is facing upwards 1 2 2 Fasten the velcro straps around the edge of the mattress support platform It is important that the straps are fas tened around the edge of the platform under the mattress and not around the bed frame as this will prevent the back thigh and foot parts of the bed from being raised The straps are long enough for thick mattresses The slide sheet is subject to extensi...

Страница 19: ...smooth ing it with your hand 2 3 3 The turning sheet must always be placed OVER the bars to prevent fingers hair etc of the client from getting caught under the sheet If the sheet is placed under the bars the pulling power will be reduced and the motors will switch off when the turning sheet is pulled in by the bar 4 Press the or button on the hand control and allow approx two thirds of the sheet ...

Страница 20: ...ng sheet onto the bar 2 4 5 5 Use the opposite bar to move the client to a supine posi tion on top of the new and the old turning sheets 6 3 4 Allow approx half of the new turning sheet to roll onto the bar and stop when the red line on the sheet is at the centre of the mattress Fold the remaining part of the new turning sheet in layers or roll it Tuck it under the turning sheet being replaced 6 R...

Страница 21: ... the mattress and the bar 3 Evacuate the client via the end of the bed Evacuation via the side of the bed In case you have power 1 Lower the bar on the evacuation side 2 Use the VENDLET to pull the client to the side of the bed and evacuate In case you do not have power 1 Lower the bar on the evacuation side 2 Cut the turning sheet between mattress and the bar Pull the client to the side of the be...

Страница 22: ... are lifted Yes No 3 Are the nylon straps attached to the bed frame and all the support bars Yes No 4 Is the the turning sheet in good condition and does the sheet run over the bars Yes No 5 Is the slide sheet fastened around the edge of the mattress support platform and in good condition Is the slippery side facing upwards Yes No 6 Double click the on the hand control Does the green diode on the ...

Страница 23: ...water nozzles The lid covering the ca ble inserts on the control unit must be closed during the entire cleaning procedure Equally all cables must be 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 unit It is furthermore recom mended that the control unit is situated as far away from...

Страница 24: ...m One of the bars does not work Are all plugs properly connected on the control unit Is the cable to the bar intact One 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 control buttons are not working Are all plugs properly connected on the control un...

Страница 25: ...ck 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 bracket for control unit 1 unit Control unit 1 unit Power cable 230 V 1 unit Hand control 1 bag 16 mounting bolts 8 unit Mounting plates 1 unit Slide sheet 1 unit Turning sheet 1 unit Quick guide 1 unit Manual ...

Страница 26: ...ess and the side rail on both sides of the mattress Likewise it is important that the mattress guides are suitable for the mat tress and will hold the mattress in place If necessary use one or two 15 mm spacers to pull the mount ing bracket away from the bed frame B In order to meet the side rail requirements the upper edge of the bars must be mounted at least 22 cm B above the mattress surface C ...

Страница 27: ... kg to be able to handle a user weight of 150 kg Max user weight VENDLET Basic Other equipment Required Bed SWL 150 kg 30 kg 25 kg 205 kg In intensive care situations the weight of other equipment is estimated to be 55 kg In this case the SWL of the bed must be at least 235 kg to be able to handle a user weight of 150 kg Max user weight VENDLET Basic Other equipment Required Bed SWL 150 kg 30kg 55...

Страница 28: ...t in the bottom of the bracket Tighten the button head bolt evenly Tighten the bracket at the foot end 3 Place the corner post as close to the headboard as possi ble Fit the button head bolt in the bottom of the bracket 4 6 Attach the outer mounting bracket in both ends and tigh ten the button head bolts evenly 3 5 6 7 Ensure that the distances meet the dimensional require ments described on page ...

Страница 29: ...at and horizon tal 2 If the mattress is an alternating airmattress make sure it s fully inflated 3 Place the bar in the highest position 4 Press the small button on the corner post 5 Simultaneously lift the corner post until the surface of the mattress is in level with the mark inside the corner post 6 Repeat the procedure at the other three corner posts Make sure all 4 corner posts are left in th...

Страница 30: ...d in 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 Electrical parts Mounting the control unit 4 3 Attach the power cord to the control unit 4 Slide the control unit onto the suspension bracket till it clicks on ...

Страница 31: ...olor code 4 Close the control unit 2 The plug on the red bar motor cable is fitted with a red O ring Connect the cable from the red bar to the control unit in the socket shown below marked with a red color code Connecting the control unit The hand control should be connected before the power cable is connected to a main plug 1 1 Connect the hand control to the control unit in the socket shown belo...

Страница 32: ...not run over the power cord with the bed Do not insert the power cord into moving parts Unplug the power supply cord before moving the bed Ensure that no cables power cord or cables from other 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 Do not position the VENDLET Basic in a way th...

Страница 33: ... bars Are the nylon straps intact Are the plastic parts intact and without signs of wear Are all wires intact 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 seconds of idle time Is the control unit securely suspended Are all cables securely attached to the control unit Have the lid on the control ...

Страница 34: ...osen the bolts in the mounting plates and turn them aside to lift VEND LET Basic off the bed frame Optionally use the mounting trolley to transport VENDLET Basic to a new destination Storage Store VENDLET Basic in the original packaging until mounting Indoor 0 50 0 C 32 F Min 50 C 122 F Max 20 90 20 90 at 30 C Keep dry Remounting Follow the procedure described in the section Mounting if remounting...

Страница 35: ...ly when the motor is disconnected from the control unit Check whether the motor has full pulling power when you press the and reduced pulling power when you press the by stopping the bar with your hand Mechanical parts Check for signs of damage damaged plastic parts and crooked fittings or brackets and missing parts Check the bars and support bars for dents deformations Check whether the groove on...

Страница 36: ...r of that bar is defect If the other bar is not working then the hand control or the control unit is defective Re place the hand control If this does not solve the problem replace the control unit Is the motor malfunctioning Replace the bar None of the above Contact a person with relevant training One or both bars does not work when a load is applied Does the turning sheet run over the bar cf page...

Страница 37: ... 2017 745 VENDLET Basic is a class I product VENDLET Basic Product no 6200000 Max user weight 150 kg Control unit Power supply SMPS 200W Mains supply 100 240 Volt AC 50 60 Hz Power rating Max 200 W Protection Class 1 IP class IPX6w Washable Intermittence 10 max 2 min 18 min Output voltage 24 Volt DC Weight Total system approx 30 kg Red side approx 14 5 kg Blue side approx 14 5 kg Control unit appr...

Страница 38: ...an be washed and handed in for recycling However very dirty sheets must be disposed of as combustible waste ESSENTIAL PERFORMANCE This equipment is compliant with IEC 60601 1 2 meaning that no loss of essential performance is found due to electromag netic disturbances The essential performance of VENDLET Basic refers to control of the bars using the hand control see page 8 9 How VENDLET Basic work...

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