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Box spring Hilo 

 

APPENDIX   

page 58 of 62 

APPENDIX 1: EC-DECLARATION HILO 

 
 

EC- DECLARATION OF CONFORMITY 

Following the EC Regulation concerning medical devices MDR EU 2017/745, annex IV. 

 

I, the undersigned, agent of the following manufacturer: 

Haelvoet nv 

 

 

 

Tel.:  

 

+32 (0) 51 48 66 95 

Leon Bekaertstraat 8   

 

Fax: 

 

+32 (0) 51 48 73 19 

8770 Ingelmunster 

 

 

Email:   

[email protected]

 

Belgium 

 

 

 

Single Registration NR: 

 
Declare hereby under sole responsibility that the following product: 

Hilo 

No.: 12376 

Basic UDI-DI.: 5430002080CarebedsH4 

Medical  device class I (non-invasive  device),  according MDR annex  VIII,  intended and made 
to treat, guard, alleviate or compensate diseases, injuries or handicaps of an adult, 

 

when installed, maintained and used in accordance with the manual, the rules of good craftsmanship, 
and  the  intended  purpose  complies  with  all  necessary  safety  requirements  and  other  relevant 
provisions of annex I of: 

Medical Devices Regulation EU 2017/745 

The following norms have been applied to indicate the conformity: 

EN 60601-1 

Medical  electrical  equipment  -  Part  1  :  General  requirements  for  basic  safety 

and essential performance.

 

EN 60601-1-2 

Medical electrical equipment - Part 1-2 : General requirements for basic safety 

and  essential  performance  -  Collateral  standard  :  Electromagnetic 

compatibility - Requirements and tests. 

EN ISO 14971 

Medical devices - Application of risk management to medical devices. 

 

The  above-mentioned  product  has  been  designed,  produced  and  checked  in  accordance  with  the 

quality management systems of 

ISO 9001:2015 

and

 ISO 13485:2016

. 

 

Ingelmunster, 22/08/2015

 

 

 

 

Signature:

 

 

 

 

 

Haelvoet Vincent 

Managing director 

Содержание Hilo

Страница 1: ...Version F 04 09 2020 IMPORTANT KEEP FOR FUTURE REFERENCE READ CAREFULLY Operating instructions And Technical manual...

Страница 2: ...Box spring Hilo OPERATING INSTRUCTIONS page 2 of 62 ACTIVATION SUMMARY...

Страница 3: ...Box spring Hilo OPERATING INSTRUCTIONS page 3 of 62 ASSEMBLY SUMMARY...

Страница 4: ...ng the product Please do not hesitate to ask for extra Hidden manuals in case this may seem necessary We kindly request you to make sure that all users and maintenance technicians have the necessary i...

Страница 5: ...c functions 15 2 2 1 Electric function possibilities 16 2 2 2 Battery option 18 2 2 3 Nightlight under the bed option 19 2 2 4 Reset Procedure 19 2 3 Moving the bed transport position 20 III POSSIBLE...

Страница 6: ...rest actuator 38 6 7 High low actuators 39 6 8 Ambient conditions for the actuators 39 6 9 Specifications of the CO61 control box 40 6 10 Precautions for cable connections 41 VII MECHANICAL TECHNICAL...

Страница 7: ...L WASTE AND THE ENVIRONMENT 53 XIV SYMBOLS 55 XV CONFORMITY AND IDENTIFICATION 56 15 1 UDI DI GTIN 56 15 2 Explanation CE label and Identification label 56 15 3 Used symbols 57 APPENDIX 1 EC DECLARATI...

Страница 8: ...limits of the lifting pole 25 Figure 3 7 IV Rod 26 Figure 3 8 How to install the mattress support 26 Figure 3 9 Bed connector 27 Figure 3 10 Placing the bed connector 27 Figure 3 11 Putting the first...

Страница 9: ...d and that the nursing staff and users should be informed of the risks involved Furthermore all bed functions should be checked annually Haelvoet NV even recommends that the bed is checked every six m...

Страница 10: ...ties or insufficient user information He also has to address himself to the distributor if he wants additional training People playing children in particular or obstacles may never be under the bed Pl...

Страница 11: ...nnect the bed immediately You also have to indicate clearly on the bed that it is OUT OF USE Furthermore contact the person who is in charge of the beds as soon as possible The bed may only be used wh...

Страница 12: ...ore the battery Never throw it in a fire Please return the replaced batteries to the manufacturer or dealer for recycling If a bed or control box with internal batteries has not been used and or conne...

Страница 13: ...al frame and the upholstered frame are in the same direction Put the metal frame in its highest position by using the hand switch Figure 2 1 Unpacking the metal frame and upholstered frame Attention b...

Страница 14: ...TRUCTIONS page 14 of 62 3 Attach the fixing plates 4 pieces at the head end and 2 pieces at the foot end of the metal frame to the head part and the foot part of the upholstered frame Figure 2 3 Fixat...

Страница 15: ...ing cases When children are near the bed without supervision If a bed manipulation can be dangerous for the user If the user is not capable of operating the bed safely or when he can put himself in da...

Страница 16: ...d switch Maximum angle of inclination 35 c High low adjustment electric This function can be activated by means of the hand switch When this function is activated the mattress platform will automatica...

Страница 17: ...Make sure that there are no objects on or around the carriage that can block a height variation Put the bed in its highest lowest position on a regular basis so that it can reset itself d Reverse Tre...

Страница 18: ...e button Never overload the bed not even for a short period In case you have no other option owing to circumstances please put all mattress platform sections in a horizontal position Also put the bed...

Страница 19: ...in a dim room The nightlight is activated by pressing the function button on the hand switch Figure 2 6 Nightlight under the bed 2 2 4 Reset Procedure A malfunction in the control box can be detected...

Страница 20: ...platform Never pull the mains cable and never remove the bed before disconnecting it from the net When the mains cable has not been stored properly during transport the risk of mains cable damage or...

Страница 21: ...Mattress support 3 1 Accessory holder The accessory holder can be attached to the right or left side of the head end of the Hilo box spring bed and is intended only for the use of a lifting pole an IV...

Страница 22: ...accessory holder dimensions The accessory holder is attached to the wooden framework of the Hilo box spring bed This can be done on both sides of the bed Predrilled holes are provided in the wooden f...

Страница 23: ...Box spring Hilo OPERATING INSTRUCTIONS page 23 of 62 3 1 3 Fixation of the accessory holder procedure Figure 3 4 Fixation of the accessory holder...

Страница 24: ...e 24 of 62 3 2 Lifting pole and IV rod The lifting pole may only be installed in the provided accessory holder Make sure to put it fully into the case of the accessory holder Figure 3 5 Installation o...

Страница 25: ...r rehabilitation exercises It is recommended to check the suspension ribbon on a regular basis It is also advised to replace the handle preventively every 4 to 5 years Figure 3 6 Exterior limits of th...

Страница 26: ...n the IV Rod 8 kg 3 3 Mattress support The Hilo box spring bed can be equipped with a mattress support at the foot This mattress support prevents the mattress and linen from sliding off the bed during...

Страница 27: ...to the wall if necessary Figure 3 9 Bed connector To put the two beds together please proceed as follows Put the bed connector in the desired position against the wall If desired the bed connector ca...

Страница 28: ...re 3 11 Putting the first bed on the bed connector Put the second bed in its highest position then put it next to the first bed not on the bed connector yet Make sure that the distance between both be...

Страница 29: ...Two people now have to put the second bed on the bed connector One person has to be within the upholstered bed frame Make sure that the pins of the bed connector fit in the bed legs Use your foot to...

Страница 30: ...mark The Lox may not be used as sideguards Other precautions should be taken when dealing with restless patients 3 5 1 Functioning of the lowerable stand up aid Lox The lowerable stand up aid Lox can...

Страница 31: ...by sliding it between the metal holder and the side of the bed 4 Lock the locking mechanism again by turning the spring button a quarter 5 Check if the Lox has been installed properly by pulling the s...

Страница 32: ...f the fact that the mains cable or electric components are not wet before connecting the bed to the net If you think that water or disinfectants have seeped into an electric component you have to disc...

Страница 33: ...put in the bed Take the clinical picture of the user and the potential presence of infected bed parts into account and adjust the number of disinfections accordingly Only qualified and trained person...

Страница 34: ...Box spring Hilo TECHNICAL MANUAL page 34 of 62 TECHNICAL MANUAL...

Страница 35: ...25 years or at least 10 000 cycles per bed function without any problems An incorrect or very intensive use of the bed affects its lifespan very negatively The same goes for bad preventive or curative...

Страница 36: ...Box spring Hilo TECHNICAL MANUAL page 36 of 62 Figure 5 1 Dimensions Hilo box spring bed Figure 5 2 Most important manipulation data of the Boxspring Hilo...

Страница 37: ...nected to the mains as mentioned on the control box label 6 2 Hand switch Type HB 8X Manufacturer LINAK Country of production Denmark Degree of protection IP66 Max current intensity 30 mA 6 3 Battery...

Страница 38: ...ld start leaking or the actuator system could get damaged The CB16 with battery back up only commences battery charging when it is connected to the mains A battery stored at 25 C has to be recharged e...

Страница 39: ...on IP X6 Input voltage 24 VDC Length of stroke 250 mm Speed 3 6 6 mm sec Sound level Max 45 dB A DS EN ISO 3746 Duty cycle Max 10 of 2 min 18 min Thrust 8 000 N Including Clamp safety 6 8 Ambient cond...

Страница 40: ...rgy saving standby mode A few seconds after a manipulation the control box is set in an energy saving standby mode As soon as a function has been manipulated the control box is activated automatically...

Страница 41: ...lacing a cable or an actuator 1 disconnect the bed from the net and wait for 5 seconds 2 remove install the necessary cables and or actuator 3 check if all cable fittings have been equipped with a rub...

Страница 42: ...es to a bed load with a user in it and with accessories mattress and options Furthermore the maximum load on the backrest by inclination is max 80 kg VIII STORAGE OF THE BED Before storing the bed you...

Страница 43: ...s obtain further information about Linak parts from Haelvoet or Linak Never perform maintenance work or repairs while the user is still in the bed In order to optimize the life span of the bed and to...

Страница 44: ...ts This instruction also applies to further maintain the safety of the bed Do not hesitate to contact Haelvoet NV if you have specific questions or if you want to order spare parts Haelvoet nv Leon Be...

Страница 45: ...ed making it possible to remove the actuator from the bed The opposite working method has to be followed to install an actuator in the bed 9 5 Replacement of a mattress platform actuator 1 Disconnect...

Страница 46: ...out when there is a load of 130 kg Obviously a lot more manipulations are possible for a backrest adjustment An alarm signal warns you during an electric manipulation in case the capacity of the batt...

Страница 47: ...ely The ventilation opening always has to be released by replacement of the battery Always replace a battery that is older than 5 years or of which the capacity is too low Faulty or old batteries incr...

Страница 48: ...rotect the battery life The deep discharge protection is activated when the battery is discharged The battery has to be discharged to exit the deep discharge mode To prevent potential problems we stro...

Страница 49: ...aft transportation Do not open the battery case as damage to the cell or circuitry may develop excessive heat Do not exceed the storage temperature 5 C to 40 C as it will shorten the product life and...

Страница 50: ...pulling the plug Figure 9 6 Replacement of the mains cable in the control box 4 Install the strain relief again Make sure that the strain relief is fixed properly and not damaged The strain relief has...

Страница 51: ...uator that is not functioning No malfunction found No Please implement the reset procedure Is the problem solved No Connect a new actuator onto the control box and check its functioning with the hand...

Страница 52: ...ng the hand switch outside the reach of the user e g at the foot end of the bed or by blocking these functions by means of the lock box XII GUARANTEE The contractual guarantee is nullified if spare pa...

Страница 53: ...int out to the consumer that waste belongs in a dustbin and not in natural areas or on the public highway This symbol known as the m bius loop can mean two things Recyclable product or This product co...

Страница 54: ...information can be obtained from the governmental agencies that are officially acknowledged for the protection of the environment or from the nearest assembly point for the collection of separated was...

Страница 55: ...htlight under the bed Warning Not following this instruction can lead to accidents with serious injuries Not following this instruction can lead to material damage to the bed and or surroundings Forbi...

Страница 56: ...ed norms EN 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basi...

Страница 57: ...mponents may not be given or destroyed with domestic waste 1 Name Article 11 Input current 2 Safe patient load 12 Input voltage 3 Medical Device 13 Safe working load 4 Conformity mark in accordance wi...

Страница 58: ...and used in accordance with the manual the rules of good craftsmanship and the intended purpose complies with all necessary safety requirements and other relevant provisions of annex I of Medical Devi...

Страница 59: ...ation of the actuator shafts All fastening clips are present Hand switch Damage Actuator hand switch supply cables Damage because the cable is jammed or cut incised Check the cable route and fixation...

Страница 60: ...nd switch option Limit switch on the actuators Automatic Performance check of the mechanical parts Complete bed functionality Hinges and virtual pivot points Smooth fluent movement Lubrication with va...

Страница 61: ...Box spring Hilo APPENDIX page 61 of 62 APPENDIX 3 TRAINING CERTIFICATE...

Страница 62: ...8 8770 Ingelmunster Belgium Tel 32 51 48 66 95 Fax 32 51 48 73 19 info haelvoet com www haelvoet com Written by Haelvoet NV All rights reserved Nothing from these operating instructions and technical...

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