Malsch bakare IMPULSE Instruction Manual Download Page 54

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This product bears the CE seal and therefore meets the requirements of German and European safety standards applicable to the
product.

Standard

Comment

MPDG

Medical devices implementation act

VO (EU) 2017 / 745

Europäische Medizinprodukteverordnung (Medical Device Regulation, MDR)

DIN EN ISO 13485

Quality management for medical products

DIN EN ISO 9001

Quality management systems

DIN EN ISO 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 electrical equipment

DIN EN 60601-1-2

EMC – electromagnetic compatibility

DIN EN 12530 / DIN EN 12531

Medical castors

DIN EN ISO 15223-1

Symbols for labelling medical products

DIN EN 1041

Symbols and information accompanying medical products

DIN 33402-1

Human body dimensions

DIN 68861-1

Furniture surfaces

BfArM recommendation

German Federal Institute for Drugs and Medical Devices

PRODUCT SAFET Y

Summary of Contents for bakare IMPULSE

Page 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...

Page 2: ...2...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 13: ...13...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 23: ...23...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 37: ...37 DS side rail dimensions...

Page 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...

Page 39: ...39 VGS side rail dimensions...

Page 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...

Page 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...

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

Page 43: ...43...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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