Vendlet 6000000 User Manual Download Page 2

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Vendlet ApS maintains the technical documentation according to Annex VII in the EU
Directives 93/42/EEC on Medical Devices.

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

Aabenraa, 14 june 2012

Peter Maindal
Director

Declaration of Conformity

As manufacturer of the products listed below VENDLET ApS, Egelund 33, DK-6200

Aabenraa, hereby declares that the products comply with the EU Directives 93/42/EEC
on Medical Devices:

Product:

VENDLET V5 and VENDLET V5+

Designation:

Electronic device for handling/turning patients

in bed

Classification, rule:

Class I according to Annex IX, rule 1 and 12

The product is tested
according to following
standards:

IEC 60601-2-52: 2009 Medical electrical equipment -
Parts 2-52: Particular requirements for basic safety and
essential performance of medical beds

Summary of Contents for 6000000

Page 1: ......

Page 2: ...below VENDLET ApS Egelund 33 DK 6200 Aabenraa hereby declares that the products comply with the EU Directives 93 42 EEC on Medical Devices Product VENDLET V5 and VENDLET V5 Designation Electronic device for handling turning patients in bed Classification rule Class I according to Annex IX rule 1 and 12 The product is tested according to following standards IEC 60601 2 52 2009 Medical electrical eq...

Page 3: ...me functionalities and use as the VENDLET V5 The instructions in this manual must be followed VENDLET ApS shall not be liable should the VENDLET V5 or VENDLET V5 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...

Page 4: ...ENDLET V5 and VENDLET V5 14 Turning 14 Moving from one side of the bed to the other 15 Repositioning the patient up in the bed 16 Applying a sling 17 Mobilizing out of bed 18 Transferring from one bed to another 19 Using the VENDLET in combination with bed functionality 20 Stop button 20 Side rails 21 Using the VENDLET system as side rails 21 When the VENDLET system is not used as side rails 22 Pr...

Page 5: ...ing 29 PART 3 TECHNICAL MANUAL UNPACKING 30 Parts list for VENDLET V5 VENDLET V5 30 MOUNTING 31 Preparations 31 Tools 31 Overview of bolts washers and nuts 31 Dimensional requirements side rails 32 Maximum loads 32 Mechanical parts 33 Attaching mounting brackets 33 Adjustment of width of mounting brackets 34 Mounting the actuator fittings with actuator 35 Mounting the support bars 35 Mounting the ...

Page 6: ...n GB4 41 Bracket for Volker 3080 41 FINAL INSPECTION CHECKLIST 42 DISMOUNTING STORAGE AND REMOUNTING 44 Dismounting 44 Storage 44 Remounting 44 MAINTENANCE CHECK 45 Annual check 45 Mechanical parts 45 Sheets 45 Functional test 45 Electrical parts 46 TROUBLESHOOTING 47 REPAIRS 49 Replacing the motor in a bar 50 Replacing the actuator 51 Replacing the velcro tape on a bar 52 SPARE PARTS 52 TECHNICAL...

Page 7: ... for dressed washed etc in bed This will often be patients who are lifted in and out of bed or patients who are mobilised using a standing aid Hence the user will typically be patients with few physical and or cognitive resources and palliative patients The VENDLET is also suitable for patients at risk of developing pressure ulcers in that the uniform and steady transfer in the sheet minimises fri...

Page 8: ...ng sheet between the two bars The turning sheet is wrapped around the two bars making it possible to move it from side to side A slide sheet is inserted under the turning sheet in order to reduce the friction of the turning sheet against the mattress The bars are fitted with an actuator at each end in order to raise and lower the bars To allow the individual adjustment of each VENDLET V5 or VENDLE...

Page 9: ...90 seconds the system produces another acoustic signal a beep beep sound the diode turns off and then the VENDLET system is off again When the VENDLET V5 or VENDLET V5 has been turned on the bars may be turned in both directions or raised or lowered 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 desir...

Page 10: ...ht extensions are available as accessories If you use a Volker Bed you need special brackets see page 41 Use special brackets to restrict the height adjustment of the bed see page 41 Wider sheets and side rail cover Wider turning sheets and slide sheets are also available if the VENDLET V5 or VENDLET V5 is to be used on wider beds see page 24 If you need it you can pur chase covers for the side ra...

Page 11: ...ents of the bed manufacturer and be suitable for the bed 2 The maximum occupant weight requirements of the mattress manufacturer must not be exceeded 3 Following the installation of the VENDLET V5 or VENDLET V5 the distance between the mattress sides and the support bar must be minimum 2 5 cm and maximum 4 cm 4 If the mattress is soft and easily compressible it must be ensured that there is no cru...

Page 12: ...bed parts are not covered by the warranty Vendlet ApS provides a 3 year warranty on all mechanical parts except sheets and side rails The normal VENDLET V5 and VENDLET V5 service life is 10 years The service life may be significantly extended if the product is used and handled with care and maintained in accordance with the guidelines in this manual IN THE EVENT OF AN INCIDENT In case of an advers...

Page 13: ...ark for Canada and the United States China RoHS P O Serial no According to EN 60601 1 the product is Type B equipment For indoor use Safety isolating transformer Product with a thermofuse User weight max Electronics scrap When disposing of the products sub components should be recycled Operating instructions Power stop button Tighten the sheet on the red or blue bar Slacken the sheet on the red or...

Page 14: ...rning The VENDLET V5 and VENDLET V5 may be used to turning patients Follow this procedure to move a patient from a supine position to lying on his her right side 1 Double click the button to activate the VENDLET V5 or VENDLET V5 2 Press the button to raise the blue bar 3 Press the button to tighten the turning sheet on the blue bar 4 Place the left arm of the patient on his her stomach or chest th...

Page 15: ... the button to activate the VENDLET V5 or VENDLET V5 2 Press the and buttons to lower the bars if they have been raised 3 Use the bar on the side to which the patient should be moved and tighten the turning sheet In many situations this will give the care giver a better work posture for example in connection with examinations training care tasks dressing etc Sound work posture in connection with e...

Page 16: ...izontal 2 Double click the button to activate the VENDLET V5 or VENDLET V5 3 Press the and buttons to lower the bars if they are raised 4 Press the and buttons to slacken the turning sheet 5 Stand next to the headboard and press the or button to pull the patient from side to side while you gently guide the turning sheet towards the upper end of the bar 6 Repeat the procedure on the opposite side a...

Page 17: ... centred and correctly placed in accordance with the instructions of the sling manufacturer 4 Use the VENDLET turning function to move the patient onto his her back again 5 Free the straps on the opposite side 6 Place all straps in such a way that they are ready to be placed on the lifting beam of the hoist Place the sling along the back of the patient All straps are in place and the patient is re...

Page 18: ... the patient sit up 6 Turn the patient on the turntable stop when his her feet protrude over the side of the bed 7 Lower the head section of the bed while supporting the patient 8 Press the or button to move the patient to the edge of the bed 9 Lower the bed until the feet of the patient reach the floor 10 Press the or button to move the patient closer to the edge of the bed and raise the bed at t...

Page 19: ...the bar facing the other bed 3 Press the or button to raise the opposite bar 4 Place a slide sheet on the other bed 5 Place the other bed right next to the bed with the VENDLET and lower or raise the bed to a slightly lower position relative to the bed with the VENDLET 6 Remember to lock the wheels on both beds 7 Press the or button to pull in the turning sheet on the bar facing the other bed Now ...

Page 20: ...of the bed Under normal circumstances the bed surface must be level before you use the VENDLET V5 or VENDLET V5 In some situations however it may be advantageous to use the back or foot part of the bed when moving or turning patients For example if the patient has wide hips and frail shoulders he she will rest more comfortably on the bed if the head and foot parts are raised a little before the pr...

Page 21: ...sides 1 Adjust the height of the bed to ensure a correct work posture 2 Press the and buttons to slacken the turning sheet enough to insert the plastic sides between the mattress and the support bar as shown in the figure 3 When the plastic sides are inserted be tween the mattress and the support bar the spacer at the bottom of the plastic side must press against the headboard and footboard This p...

Page 22: ... pinned between the parts The distance between the bed frame and the lower edge of the bar will ex ceed 12 cm This could cause the patient to fall through this opening head or feet first with a risk of getting pinned between the parts If side rail support bars have not been mounted when the plastic sides are used there is a risk that The plastic sides will be pressed out and the sheet will be roll...

Page 23: ... higher comfort to the patient during the process Incontinence VENDLET V5 and VENDLET V5 can also be used for patients using incontinence sheets The in continence sheet should have a minimum width of 125 cm so that it can follow the patient s movements during turning You should not use two small incontinence sheets as the patient in this case will lie on a double edge which in creases the risk of ...

Page 24: ...d folds Make sure that slippery side is facing upwards 3 Fasten the velcro tapes around the mattress frame It is important that the tapes are fastened around the frame 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 tapes are long enough for thick mat tresses The slide sheet is subject to extensive wear and must be...

Page 25: ...ss the turning sheet onto the velcro strip on the opposite bar 6 Use this bar to pull in the turning sheet by pressing the or button until the sheet covers the mattress evenly with the red line at the centre of the mattress The red line should be at the centre of the mattress to the extent possible as this will not only ensure as much manoeuvrability as possible when the VENDLET is used but also f...

Page 26: ... the new turning sheet onto the bar 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 of 15 cm and place it under the turning sheet being replaced 4 Move the patient to a supine position on top of the folded new and old turning sheets and then on to the ...

Page 27: ...lative to when the VENDLET was mounted Yes No 7 Are the care givers familiar with the instructions of this manual and have they received training in the use of the VENDLET Yes No 8 Is the quick guide located at an easily accessible spot near the bed Yes No 9 Has it been verified that the date of the next annual inspection has not come and gone Yes No DAILY MAINTENANCE The VENDLET V5 VENDLET V5 sys...

Page 28: ...NDLET V5 or VENDLET V5 system Washing instructions slide sheet Recommended washing temperature 60o C Do not tumble dry Do not iron Washing instructions turning sheet Recommended washing temperature 95o C Max 4 shrinking Always tumble dry at normal temperatures to ensure the continued function of the velcro band Stretch 2 3 times during the drying process to prevent the turning sheet from losing it...

Page 29: ...he turning sheet running under the bars The sheet must be over the bars Are all plugs properly connected on the control unit One of the bars will only turn in one direction Are all plugs properly connected on the control unit The symbols on the hand control do not match when the VENDLET is activated Are all plugs properly connected on the control unit The actuators cannot be raised lowered or do n...

Page 30: ... until mounting Always store the VENDLET system in a dry place cf the Environmental Considerations section Parts list for VENDLET V5 VENDLET V5 1 unit Bar red side 1 unit Bar blue side 2 unit Actuator fittings blue side 2 unit Actuator fittings red side 4 set Mounting bracket with mounting plate 2 unit Support bars 1 unit Suspension plate for the control unit 1 unit Control unit with transformer 1...

Page 31: ...ent and whether the situation at hand requires special considerations For example it could be necessary to take special precautions if the patient is restless in bed Likewise it must be ensured that the care givers have been trained in the proper use of the VENDLET V5 Preparations Tools You need an Allen key 5 and a 13 mm single end wrench to mount the VENDLET V5 Use an Allen key 4 if spacers are ...

Page 32: ...n the bed never exceeds this limit H A distance of 2 5 4 cm is required between the mattress and the VENDLET on both sides of the mattress meaning that the difference between the T and M measures must be between 5 cm and 8 cm Likewise it is important that the mattress guides are suitable for the mattress and will hold the mattress in place In order to meet the side rail requirements the upper edge...

Page 33: ...stment of width of mounting brackets 1 Place the mounting bracket contact face on top of the bed frame as close to the headboard as possible The mounting bracket must be perpendicular to the bed frame 2 Insert the 8 x 20 mm or longer if spacers are used or the bed frame is wider than 30 mm button head screws in the holes and hold the mounting plate against the inner side of the bed frame Attach it...

Page 34: ... bolt set The bolt set contains the following items 4 6 x 6 mm button head For 1 spacer 4 6 x 16 mm button head For 2 spacers 4 6 x 26 mm button head For 3 spacers When using spacers the button head bolts for support bars and mounting brackets must be replaced as described on page 31 You will need to use top plates if you are using 2 or 3 spacers Insert the two pins of the top plate in the holes o...

Page 35: ...o fix the actuator fitting in the desired position at the desired height Apply pressure to the adjustment screw to ensure its full insertion Apply pressure to the actuator fitting to check if it has locked in place 3 Use this procedure to attach all four actuator fittings Mounting the support bars Mount the support bar on each side between the two actuator fittings You will need two 8 x 20 mm butt...

Page 36: ...ould be tightened to the point only when the bolt meshes with the actual lock component Adjustment of the height of the actuator fittings The bars must be mounted in such a way that their tops are 22 23 cm above the surface of the mattress This is achieved by releasing the adjustment screw on the back of the mounting bracket and elevating the actuator fitting to the desired height The fitting has ...

Page 37: ... on all four ac tuator fittings using the 8 x 35 mm button head bolts self locking nuts and washers 3 Mount a 3 hole fitting on all four actuator fittings using two 8 x 20 mm button head bolts self locking nuts and washers 4 Mount the support bar at the top of the 3 hole fitting 5 Mount the bars on the height extensions 6 Adjust the height of the actuator fittings to position the bar tops 22 23 cm...

Page 38: ...ol unit The suspension plate is able to fit bed frames that are between 1 7 and 4 1 cm wide 3 Adjust the width of the suspension plate to suit the current bed frame Tighten the suspension plate around the bed frame with the two fingerscrews 4 The suspension plate will not fit all kind of beds If it is not possible to mount the suspension plate any where the control unit must be attached with cable...

Page 39: ...e that they will rest firmly against the bed frame use at least four cable ties on each side of the bed Connecting the hand control Connect the hand control to the control unit in the plug by this symbol on the control unit The hand control should always hang on the outside of the bed such as on the outside of the headboard The hand control should be connected before the actuator and power cables ...

Page 40: ...n of power cables The last step is to connect the control unit power cable to an easily accessible 230V mains plug The green diode on the control unit illuminates when the power is turned on Keep all cables away from the floor and the moving parts of the bed Once the mounting is complete all loose cables must be wrapped around the control unit mounting fixture cable guides and secured to prevent t...

Page 41: ...ontrol Height restriction bracket On some bed types the VENDLET system can conflict with the bed wheels or brake when the bed is lowered The height restriction bracket ensure that the bed can not be lowered too much to create a conflict Height restriction switch for Guldmann GB4 The height restriction bracket can not be used for the Guldmann GB4 care bed Instead this height restric tion switch mus...

Page 42: ...y following the checklist below The list may also be downloaded at www vendlet com The desired result of the procedure is a situation where all Yes checkboxes have been marked If one or more No checkboxes have been marked the matter should be investigated and you should consider stop using the VENDLET until the situation has been remedied and a solution found ...

Page 43: ...e Is the control unit securely suspended Are all cables securely attached to the bed with cable ties and away from the moving parts of the bed Are all loose cables off the floor and wrapped around the cable guides on the control unit suspension plate Is the slide sheet fitted on top of the mattress and properly attached Is the turning sheet fitted in such a way that it turns properly on the bars I...

Page 44: ...tings from the mounting brackets Coil up the actuator cables and secure them using cable ties 7 Dismount the mounting brackets with mounting plate and spacers if any 8 Pack all parts carefully together Store bolts nuts and washers in a bag Check all bolts and nuts for signs of damage and discard all damaged parts Storage The VENDLET system should be stored in a dry location Temperature 10 C 50 C R...

Page 45: ...bar velcro tapes are attached and in good condition Sheets Is the turning sheet in good condition Is the slide sheet in good condition Functional tests Do all bolts and nuts match the parts list and are they evenly tightened Is there a 1 mm clearance between the end of the bar and the slide sleeve of the top fitting Check whether all four side rails are in place and in good condition Does the moun...

Page 46: ...s and relief cables When using an extension cable check whether the cable has the necessary quadrant 1 0 mm2 Check the stop function Bars Red side Blue side Check the motor for signs of damage Check all cables plugs and relief cables for signs of damage Check whether the bar may be operated manually when the motor is disconnected from the control unit Check whether the motor has full pulling power...

Page 47: ...ntrol or the control unit is defective Replace the hand control If this does not solve the problem replace the control unit Reset the system by simultaneously pressing the two top buttons on the hand control You will hear a series of rhythmic beeps Press and hold the buttons until the beeping stops Replace the bar motor Contact a qualified technician or Healthcare Lifting Specialist One or both ba...

Page 48: ... the system by simultaneously pressing the two top buttons on the hand control You will hear a series of rhythmic beeps Press and hold the buttons until the beeping rhythm changes Replace the hand control Contact a qualified technician or Healthcare Lifting Specialist One or more actuators will not go up or down Is the plug properly connected to the control unit Is the cable intact If the actuator...

Page 49: ...placement On the next pages we will explain the more general repairs Please do not hesitate to contact us or our consultants if you need assistance or guidance or a qualified technician from Healthcare Lifting Specialist to perform re pairs or troubleshooting All repairs must be carried out by a qualified technician ...

Page 50: ...tor fitting on the new motor and attach it using the pivot screw 7 Place the motor inside the bar and attach it using the Allen screw you removed earlier 8 Mount the bar on the two actuator fittings and connect the cable to the control unit 9 Reconnect the power cable to the mains outlet 10 Reset the system by simultaneously pressing the two top buttons on the hand control You will hear a series o...

Page 51: ...uator cable from the defective actuator and install it on the new actuator 7 Mount the new actuator on the actuator fitting and attach it using the two Allen screws 8 Secure the actuator cable with two new cable ties and route it along the inside of the bed frame to the control unit Use cable ties to secure the actuator cable along the bed frame in such a way that the cable will not get caught by ...

Page 52: ...pe is secured run a hard roller over the velcro tape several times to ensure optimal adhesion to the bar and remove air pockets from the underside of the velcro tape 4 You should always use original velcro tape from Vendlet ApS SPARE PARTS All individual components are delivered as complete units as spare parts Please contact Healthcare Lifting Specialist for further information TECHNICAL DATA In ...

Page 53: ...DC IP class IPX6 IPX6 Intermittence 10 10 Weight Total system weight approx 42 kg approx 42 5 kg Actuator fittings w actuator 3 75 kg 3 75 kg Bar 6 kg 6 kg Support bar 2 units 3 kg 3 kg Control unit 2 5 kg 2 5 kg Plastic side rail 4 units 8 kg 8 kg Length 195 cm 195 cm Width May be adapted to beds between 70 cm and 130 cm Expected service life 10 years 10 years Noise level max load 65 dB A 65 db A...

Page 54: ...LET V5 or VENDLET V5 system with general household waste On disposal of a VENDLET V5 or VENDLET V5 system Vendlet ApS recommends that the system be divided into individual parts and components with a view to recycling All mechanical steel components may be disposed of as metal parts The control unit must be disposed of as electronic waste Furthermore it may be divided into metal waste cable waste ...

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