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CERTIFICATE

DIN EN ISO 14001:2015

for a management system as per

Evidence of conformity has been furnished.

Certificate registration No.

73 104 1297

Audit report No. 4404 1931

First certification 2013-10-01

Certificate valid from 2022-10-01 to

2025-09-30

scope:

PAGE 1 OF 1.

This certification confirms the introduction and maintenance of the Management system specified above and is monitored regularly.

The current validity is verifiable at www.proficert.com. Original certificates contain a glued hologram.

TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Strasse 16, D-64293 Darmstadt, Germany, Phone +49 6151/600331 Rev-GB-2001

Darmstadt, 2022-09-30

Certification body of TÜV Hessen

– Head of Certification body –

Malsch GmbH

Rohbergstraße 9

36208 Wildeck - Obersuhl

Germany

Development, manufacturing and distribution of

clinic- and health care bed systems, room furnishing

CERTIFICATE

DIN EN ISO 9001:2015

for a management system as per

Evidence of conformity has been furnished.

Certificate registration No.

73 100 1297

Audit report No. 4404 1931

First certification 2004-07-21

Certificate valid from 2022-10-01 to

2025-09-30

scope:

PAGE 1 OF 1.

This certification confirms the introduction and maintenance of the Management system specified above and is monitored regularly.

The current validity is verifiable at www.proficert.com. Original certificates contain a glued hologram.

TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Strasse 16, D-64293 Darmstadt, Germany, Phone +49 6151/600331 Rev-GB-2001

Darmstadt, 2022-09-30

Certification body of TÜV Hessen

– Head of Certification body –

Malsch GmbH

Rohbergstraße 9

36208 Wildeck - Obersuhl

Germany

Development, manufacturing and distribution of

clinic- and health care bed systems, room furnishing

CERTIFICATE

ISO 13485:2016

EN ISO 13485:2016+AC:2016

for a management system as per

Evidence of conformity has been furnished.

Certificate registration No.

73 105 1297

Audit report No. 4367 3534

First certification 2017-07-11

Certificate valid from 2022-06-14 to

2023-07-10

scope:

PAGE 1 OF 1.

This certification confirms the introduction and maintenance of the Management system specified above and is monitored regularly.

The current validity is verifiable at www.proficert.com. Original certificates contain a glued hologram.

TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Strasse 16, D-64293 Darmstadt, Germany, Phone +49 6151/600331 Rev-GB-2001

Darmstadt, 2022-06-14

Certification body of TÜV Hessen

– Head of Certification body –

Malsch GmbH

Rohbergstraße 9

36208 Wildeck - Obersuhl

Germany

Development, manufacturing and distribution of

clinic- and health care bed systems, room furnishing

CERTIFICATES

Содержание AYLEEN CARE BED

Страница 1: ...CARE DESIGN AYLEEN CARE BED INSTRUCTION MANUAL...

Страница 2: ...2...

Страница 3: ...re while maintaining the highest safety standards Thank you very much for the trust you have placed in us Our company guarantees carefully selected materials and contin uous quality control while empl...

Страница 4: ...rcarriage Edition 400HC 20 AYLEEN care bed with undercarriage Edition 400N 21 AYLEEN care bed with undercarriage Edition XL 22 AYLEEN care bed Edition 500 23 Description of function 24 Back rest 24 Me...

Страница 5: ...and control holder 36 Integrated bed linen holder 36 Troubleshooting 37 Product safety 38 Cleaning and disinfection 39 Disinfection 39 Care of wooden parts 39 Safe decommissioning storage 40 Warranty...

Страница 6: ...RODUCT RANGE AYLEEN care bed with undercarriage Edition 400HC AYLEEN care bed with undercarriage Edition XL AYLEEN care bed with undercarriage Edition 400N AYLEEN care bed with undercarriage Edition 5...

Страница 7: ...and care homes or compa rable medical facilities This complies with working environment 3 and 5 as stipulated by IEC 60601 2 52 2009 AMD1 2015 Prior written consent from Malsch GmbH is required if th...

Страница 8: ...st time The instruction manual must be used for this training The instruction manual has been written for the AYLEEN care bed The images graphics and texts it contains may differ from the equipment su...

Страница 9: ...e the residents do not come into contact with the side rails to avoid trap ping any part of the body The functionality of the side rails must be checked every day They must not bear any load of over 7...

Страница 10: ...accordance with IEC 60601 2 52 2009 AMD 2015 when choosing a mattress it is important that there is a minimum distance of 22cm between the top of the sleep ing surface and the top of the side rail in...

Страница 11: ...the manufacturer as part of the inspections and maintenance service for medical devices Electrically operated care beds are active medical devices and must be listed in an inventory for each site in...

Страница 12: ...GmbH can cause increased emissions of electromagnetic interference or reduce the electromagnetic interference resistance of the device and thus lead to faulty operation Portable HF communication devic...

Страница 13: ...13...

Страница 14: ...ss com pensation AYLEEN care bed with undercarriage Edition 400N 100x206 90x200 27 to 81 Approx 120kg Total 180kg 145kg resident 20kg mattress 15kg accessories 33 71 12cm Mattress com pensation AYLEEN...

Страница 15: ...4 Protection class II Lifting system force Lifting system force 1x6000N 2x6000N Sleeping surface adjustment force 2x4000 N 4x4000N Motor running time on 2 max off 18 min Data on operation transport an...

Страница 16: ...t Operation Protection 1 2 3 4 5 6 7 8 9 10 11 12 NEXT I N S P E C T I O N 2024 100 240VAC50 60Hz 2 1 0 9A 35VDC2A max 2min ON 18min OFF IPX4 145kg 180kg 300kg 01 4065848000106 21 012104001234567 240...

Страница 17: ...ical equipment from water spray only use in dry areas 7 Indicates the next technical check after delivery in line with VDE0751 1 8 Explanation of the safety symbols used on the rating plate Labelling...

Страница 18: ...body weight and height are below these limits or who have a BMI under 17 as the risk of injury is increased for this group Symbol Label indicating replaceable mattresses in line with IEC 60601 2 52 20...

Страница 19: ...igh rest down S6 Auto contour down S8 Height adjust ment down HC 147 HAND CONTROLLER SYMBOLS R1 LOCKED No functions operational R2 R4 UNLOCKED All functions available Locking functions positioned on t...

Страница 20: ...or IV drip holder and accessories 4x surrounding the bed 7 Full length side rail 8 Release button for full length side rail 9 Lower leg rest adjustable ratchet 10 100mm single castors with castor brak...

Страница 21: ...for IV drip holder and accessories 4x surrounding the bed 7 Full length side rail 8 Release button for full length side rail 9 Lower leg rest adjustable ratchet 10 100mm single castors with castor br...

Страница 22: ...for IV drip holder and accessories 4x surrounding the bed 7 Full length side rail 8 Release button for full length side rail 9 100mm twin castors with castor brake1 AYLEEN care bed with undercarriage...

Страница 23: ...1 2 1 Adjustable lower leg rest 2 Adjustable thigh rest 3 Static seat section 4 Adjustable back rest 5 Lower leg rest adjustable ratchet 6 Height adjustable feet FUNCTION ILLUSTRATION AYLEEN care bed...

Страница 24: ...PTION OF FUNCTION Depending on the design and type of care bed it can be moved into various positions by adjusting the back rest the thigh rest low er leg rest and the lift adjustment Back rest Use th...

Страница 25: ...ontour Ensure that that no ob jects or parts of the body are located in the area of the lifting mechanism Height adjustment Use the relevant buttons on the hand controller to adjust the height Height...

Страница 26: ...bed with undercar riage Edition 500 is a stationary lifting frame to retrofit existing bed conver sions To do so the lifting frame is in stalled in place of the slat frame The horizontal adjustment wi...

Страница 27: ...g when using the inser tion frame in a double bed Before adjusting the sleeping surface it is imperative to check that no body parts are below the moving elements Caution Prior to the first use of the...

Страница 28: ...ion Slightly lift the upper side rail bar by the side rail groove B while at the same time pushing in the safety button A Slowly lower the side rail to the lowest position Repeat the process at the ot...

Страница 29: ...for standard sleeping surface 90x200cm dimensions for other lengths will differ When using the comfort sleeping surface DS side rail dimensions When using with ABS metal mesh metal slats and wooden sl...

Страница 30: ...e and maintenance tasks must not be conduct ed when the bed is occupied The residents or the care staff must not conduct maintenance tasks Procedure 1 Visual inspection Check the welded structures for...

Страница 31: ...sections D 60 or D 318 E Distance between split side rails with reclining surface in a level position E 60 or E 318 F The largest dimension in at least one direc tion of every opening below the side r...

Страница 32: ...h specifications at least every 2 years or after every case of emergency lowering 9 Measurements in line with DIN EN 62353 Check the electrical components of the care bed as specified in DIN EN 62353...

Страница 33: ...a defect occurs DELIVERY AND ASSEMBLY Malsch GmbH care beds are generally delivered fully assembled or they are assembled on site by company technicians or con tractual partners Check the delivered b...

Страница 34: ...of the components being disposed of are infectious contaminated If the bed is scrapped the wood plastic and metal parts used in its construction must be separated and disposed of properly If you have...

Страница 35: ...g surface frame to the left or right of the head foot end The IV drip holder is only intended for attaching IV drips and not for hanging up other accessories or similar objects The maximum load is 8kg...

Страница 36: ...reach of the resident Caution The hand control holder is flexible and must not be used as a standing aid or as a grab handle Integrated bed linen holder The integrated bed linen holder can be extended...

Страница 37: ...safe working load has been exceeded Reduce the load Drives cut out after a long period of oper ation The adjustment time or safe working load has been exceeded and the control unit has reacted to ove...

Страница 38: ...edical electrical equipment General requirements for safety DIN EN 60601 1 2 Medical electrical equipment Electromagnetic EM disturbances IEC 60601 1 6 Medical electrical equipment Usability DIN EN IS...

Страница 39: ...d and protect the drive system from moisture We provide separate instructions for cleaning and disinfecting our care beds Care of wooden parts Malsch care beds only use wood surrounds that are finishe...

Страница 40: ...care beds so that the wood surround and the frame cannot be damaged To ensure the necessary regular maintenance intervals attach the storage date on the bed in a visible location Lock the hand control...

Страница 41: ...915 100 Fax 49 0 6626 915 116 SRN DE MF 000005173 declares under its sole responsibility that the devices named below comply with the essential requirements and provisions of Regulation EU 2017 745 fo...

Страница 42: ...anagement system specified above and is monitored regularly The current validity is verifiable at www proficert com Original certificates contain a glued hologram T V Technische berwachung Hessen GmbH...

Страница 43: ...43 NOTES...

Страница 44: ...03 0 EN Updated 01 2023 Rev 3 0 Colours may vary Subject to technical changes Malsch GmbH Rohbergstra e 9 36208 Wildeck Obersuhl Germany Tel 49 0 6626 915 100 Fax 49 0 6626 915 116 bettenmalsch com in...

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