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CERTIFICATES

DIN EN ISO 14001:2015

Management system as per

Evidence of conformity with the above standard(s) has been furnished

and is certified in accordance with TÜV PROFICERT procedures for

PAGE 1 OF 1.

This certification was conducted in accordance with the TÜV PROFiCERT auditing and certification procedures and is subject to

regular surveillance audits. Verifiable under www.tuev-club.de. Original certificates contain a glued on hologram.

TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1711

Darmstadt, 2019-09-26

Certification body of TÜV Hessen

– Head of Certification body –

DIN EN ISO 9001:2015

Management system as per

Evidence of conformity with the above standard(s) has been furnished

and is certified in accordance with TÜV PROFICERT procedures for

PAGE 1 OF 1.

This certification was conducted in accordance with the TÜV PROFiCERT auditing and certification procedures and is subject to

regular surveillance audits. Verifiable under www.tuev-club.de. Original certificates contain a glued on hologram.

TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1711

Darmstadt, 2019-09-26

Certification body of TÜV Hessen

– Head of Certification body –

ISO 13485:2016

EN ISO 13485:2016+AC:2016

Management system as per

Evidence of conformity with the above standard(s) has been furnished

and is certified in accordance with TÜV PROFiCERT procedures for

PAGE 1 OF 1.

This certification was conducted in accordance with the TÜV PROFiCERT auditing and certification procedures and is subject to

regular surveillance audits. Verifiable under www.proficert.com. Original certificates contain a glued on hologram.

TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1904

Darmstadt, 2020-04-06

Certification body of TÜV Hessen

– Head of Certification body –

Содержание bakare IMPULSE

Страница 1: ...IMPULSE CARE BED INSTRUCTION MANUAL CARE DESIGN 2021 Rev 2 1 DE Stand 05 Item no 91300 100002 1 Malsch Version Bakare Beds Version Rev 1 Initial Issue Updated 26 4 22...

Страница 2: ...2...

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

Страница 4: ...esign without axial tilting sleeping surface 20 IMPULSE care bed with undercarriage Edition 420 Edition 420LR 21 Functions 22 IMPULSE care bed with undercarriage Edition 400 23 IMPULSE care bed with u...

Страница 5: ...tension 42 Maintenance 44 Procedure 44 Battery replacement 46 Maintenance intervals 47 Delivery and assembly 47 Disposal instructions 48 Accessories optional 49 Trapeze bar 49 IV drip holder 49 Bedsid...

Страница 6: ...IMPULSE care bed with undercarriage Edition 400 IMPULSE care bed with undercarriage Edition 420 IMPULSE care bed with undercarriage Edition XL IMPULSE care bed with undercarriage Edition 400LR IMPULSE...

Страница 7: ...s or com parable medical facilities This complies with working environment 3 and 5 as stipulated by IEC 60601 2 52 2009 AMD1 2015 Prior written consent from Betten Malsch GmbH is required if the care...

Страница 8: ...he instruction manual must be used for this training The instruction manual has been written for the IMPULSE care bed The images graphics and texts they contain may di er from the equipment supplied T...

Страница 9: ...of the body The functionality of the side rails must be checked every day They must not bear any load of over 75kg vertically or over 50kg horizontally When using CPR optional mechanical emergency low...

Страница 10: ...licable safety standards The constant presence of liquid in the area of the motor must be avoided e g incontinence For safety reasons the handle on the trapeze bar must be replaced completely every 5...

Страница 11: ...ble to also document the correct implementation of the required technical safety checks in this inventory and to specify the date of the next inspection The required protocols concerning technical saf...

Страница 12: ...nce or reduce the electromagnetic interference resistance of the device and lead to faulty operation Portable HF communication devices radio devices in cluding their accessories such as antenna cables...

Страница 13: ...13...

Страница 14: ...196x90 190x80 196x100 190x90 206x90 200x80 206x120 200x110 206x130 200x120 226x100 220x90 IMPULSE care bed with undercarriage Edition 400LR 206x100 200x90 26 to 82 approx 120kg 225kg total 190kg resi...

Страница 15: ...o 7 5 11 5A DC Over voltage o 45 V DC Standby operation max 0 5W Protection IPX4 Protection class II Pressure force Lifting system force 2x3000N 2x3000N 1x8000N 2x6000N RS adjustment force 2x3000N 2x3...

Страница 16: ...ample illustration of a rating plate of an IMPULSE with UDI Input Output Operation Protectionclass xx xxxxxxxxxxxxx xx xxxxxxxxxxxxx xxx xxxxxxxxxxxxxxxx xxx xxxxxxxxxxxxxxxx 1 2 3 4 5 6 7 8 9 10 11 1...

Страница 17: ...n dry areas protection rating class II double insulation protective insulation 7 Indicates the next technical check after delivery in line with VDE0751 1 8 Explanation of the symbols used on the ratin...

Страница 18: ...weight and height are below these limits or who have a BMI under 17 as the risk of injury is significantly increased for this group Symbol Label indicating replaceable mattresses in line with IEC 6060...

Страница 19: ...rs2 low position1 1 not with IMPULSE Edition 100 2 only with IMPULSE Edition 100 IMPULSE care bed with undercarriage Edition 100 Edition 400 Edition 400LR Edition XL design with axial tilting sleeping...

Страница 20: ...adjustment down S3 Foot section adjustment up S5 Auto contour up S7 Lift adjustment up S4 Foot section adjustment down S6 Auto contour down S8 Lift adjustment down S10 Comfort seating R1 LOCKED No fu...

Страница 21: ...oot section adjustment down S6 Auto contour down S8 Lift adjustment down R1 LOCKED No functions operational R2 R4 UNLOCKED All functions available HAND CONTROLLER SYMBOLS HC 147 IMPULSE care bed with...

Страница 22: ...ng the magnetic chip and simultaneously pressing the button with the lock symbol the function is relea sed again and the respective LED goes out Foliendesign HB 400 LINAK 2 Revision K1 Produkt Pflegeb...

Страница 23: ...23...

Страница 24: ...100 24 1 Head foot board 2 Adjustable lower leg section 3 Adjustable upper leg section 4 Seat section fixed 5 Adjustable back rest 6 Trapeze bar mounts on both sides at head end of sleeping surface 7...

Страница 25: ...Adjustable lower leg section 4 Adjustable upper leg section 5 Seat section fixed 6 Adjustable back rest 7 Trapeze bar mounts on both sides at head and foot end of sleeping surface 8 Mechanical CPR em...

Страница 26: ...lower leg section 4 Adjustable upper leg section 5 Seat section fixed 6 Adjustable back rest 7 Trapeze bar mounts on both sides at head and foot end of sleeping surface 8 Mechanical CPR emergency low...

Страница 27: ...ustable lower leg section 4 Adjustable upper leg section 5 Seat section fixed 6 Adjustable back rest 7 Trapeze bar mounts on both sides at head and foot end of sleeping surface 8 Swivelling side rails...

Страница 28: ...tion 4 Adjustable upper leg section 5 Seat section fixed 6 Adjustable back rest 7 Trapeze bar mounts on both sides at head and foot end of sleeping surface 8 Swivelling side rails GS V21 9 Telescopic...

Страница 29: ...sion 10 20cm 3 Adjustable lower leg section 4 Adjustable upper leg section 5 Seat section fixed 6 Adjustable back rest 7 Trapeze bar mounts on both sides at head and foot end of sleeping surface 8 Swi...

Страница 30: ...ION OF FUNCTION Depending on the design and type of care bed the bed can be adjusted into various positions by adjusting the back rest the up per leg section the lower leg section and the height of th...

Страница 31: ...Please consider resident safety when ad justing the auto contour Ensure that no body parts or any objects are located in the area of the lifting mechanism Height adjustment Use the corresponding butt...

Страница 32: ...ot with IMPULSE care bed with undercarriage Edition XL and Editions 420 420LR Use the corresponding buttons on the hand controller to adjust the bed to the Trendelenburg position Trendelenburg positio...

Страница 33: ...ted in the table on p 14 Technical data Caution Please consider resident safety when ad justing the bed inclination Ensure that no body parts or any objects are located in the area of the lifting mech...

Страница 34: ...e locked functions are released in the same way By placing the magnetic chip and simultaneously pressing the button with the lock symbol the function is released again and the respective LED goes out...

Страница 35: ...60 movement foot pedal in the middle 3 1 castor set to a fixed direction foot pedal up IMPULSE care bed with undercarriage Edition 420LR The IMPULSE Edition 420LR model with optional castor sizes of 1...

Страница 36: ...er side rail 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 other end of the bed Caution Wh...

Страница 37: ...37 DS side rail dimensions...

Страница 38: ...eight Perform telescopic adjustments using both hands simultaneously when moving the rail upwards or downwards to prevent jamming Fig 3 Do not force the movement 4 To lower the telescoping side rail h...

Страница 39: ...39 VGS side rail dimensions...

Страница 40: ...ig A 1 2 The side rail extension can be released using the two spring catches below the handrail for telescop ic movement and adjusted to its maximum height Pull the rail upwards using both hands simu...

Страница 41: ...r the resident Fig A 1 2 The side rail extension can be released using the two spring catches below the handrail for telescop ic movement and adjusted to its maximum height Pull the rail upwards using...

Страница 42: ...42 VGS side rail dimensions When using the ABS metal lattice sleeping surface When using the comfort sleeping surface...

Страница 43: ...43...

Страница 44: ...ions 420 420LR the locking bolts point laterally inwards The mode of operation is analogous to the chassis editions described above The bed extension is now unlocked 2 Reach below the foot board and c...

Страница 45: ...ety it is essential to re place existing safety elements and attachments if the sleeping surface extension is activated on beds with full length side rails 1 2 3 Locking bolts IMPULSE care bed with un...

Страница 46: ...Service and maintenance tasks must not be con ducted when the bed is occupied The resident or the care sta must not conduct maintenance tasks Procedure 1 Visual inspection Check the welded structures...

Страница 47: ...D 318 E Distance between split side rails with sleeping 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 rail If D 250 F 60...

Страница 48: ...r 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 Leakage current is measured using substitute le...

Страница 49: ...ss and conformity Any defects or damage must be pointed out to the freight com pany immediately and noted on the delivery document Signing of the delivery documents by both parties is obligatory befor...

Страница 50: ...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 51: ...ace 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 2kg p...

Страница 52: ...ch of the resident Caution The hand controller bracket is flexible and must not be used as an aid to standing up or as a handle Integrated bed linen holder The integrated bed linen holder can be easil...

Страница 53: ...safe working load has been exceeded Reduce the load Drives cut out after a long period of operation The adjustment time or safe working load has been exceeded and the control unit has reacted to over...

Страница 54: ...SO 14001 Environmental management systems DIN EN ISO 14971 Risk analysis DIN EN 12182 Technical aids for disabled persons DIN EN 60601 2 52 Medical electrical equipment DIN EN 60601 1 Medical electric...

Страница 55: ...ng and disinfecting our care beds Care of wooden parts Malsch care beds only use wooden parts that are finished in com pliance with the DIN 68861 1A standard The aim is to produce a comfortable design...

Страница 56: ...eep discharge Remove any accessories such as bed lamps trapeze bars etc Cover the care beds so that the wooden parts and the frame cannot be damaged Mark the storage date clearly on the bed so that ma...

Страница 57: ...supplies buildings used for residential purposes HF emissions IEC 61000 3 2 Class A Voltage fluctuations and flicker IEC 61000 3 3 Compliant Guidelines and manufacturers declarations electromagnetic r...

Страница 58: ...hat of a typical business or hospital environment Cable to ground Conducted disturbances induced by high frequency fields IEC 61000 4 6 3 V 3 V 6 V in ISM and amateur radio frequency bands 6 V in ISM...

Страница 59: ...Hz deviation 1 kHz sine 2 0 3 28 710 704 to 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 145 780 810 800 to 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3...

Страница 60: ...tung der Bestimmungen der Verordnung EU 017 745 werden die Anforderungen zur Anbringung einer CE Kennzeichnung erf llt Aufgrund der Spezifikation als Medizinprodukt Klasse I werden Produkt und Verpack...

Страница 61: ...n was conducted in accordance with the T V PROFiCERT auditing and certification procedures and is subject to regular surveillance audits Verifiable under www tuev club de Original certificates contain...

Страница 62: ...ohbergstra e 9 36208 Wildeck Obersuhl Germany Tel 49 0 6626 915 100 Fax 49 0 6626 915 116 bettenmalsch com info bettenmalsch de Bakare Beds Ltd Unit 1a Bluewater Estate Plymouth Devon GB Phone 01752 5...

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