background image

60 

|

By purchasing a care bed from Betten Malsch GmbH, you have 
chosen a premium, high-quality product. 

Malsch care beds are covered by a 24-month warranty calcu-

lated from the date of purchase.

In the event of material or manufacturing faults occurring within 

the warranty period, the bed will be replaced or repaired free 

of charge. 

This excludes faults and errors caused by inappropriate handling 

or external infl uences. 

Our normal terms of business and delivery apply. 

If you have any questions, please contact us on
the following numbers:

Customer service 

Phone:  +49 (0) 6626 915-100
Fax: 

+49 (0) 6626 915-127

[email protected]

bettenmalsch.com

WARR ANT Y

AND SERVICE

DECL AR ATION OF CONFORMIT Y

Betten Malsch GmbH

Geschäftsf. Gesellschafter: Rayk Malsch

Amtsgericht Bad Hersfeld, HRB 1510

Erfüllungsort: Wildeck

Steuernummer: 025/229/35183

USt.-Ident.-Nr.: DE 223 637 968 

AGB einsehbar unter bettenmalsch.com

Firmenzentrale

Rohbergstraße 9

D-36208 Wildeck-Obersuhl

Tel.: +49 (0) 6626 915-100

Fax: +49 (0) 6626 915-116

E-Mail: [email protected]

Deutsche Bank AG

IBAN: DE14 5327 0012 0864 3553 01

BIC:  DEUTDEFF532

VR-Bank NordRhön eG

IBAN: DE25 5306 1230 0003 4000 00

BIC:  GENODEF1HUE

DE

EG-Konformitätserklärung

nach der Verordnung (EU) 2017/745 des europäischen Parlaments 
und des Rates vom 5. April 2017 über Medizinprodukte, Anhang IV.

Der Hersteller

Betten Malsch GmbH

Rohbergstraße 9
36208 Wildeck-Obersuhl, Deutschland

Tel. +49 (0) 6626 915-100
Fax +49 (0) 6626 915-116

erklärt in alleiniger Verantwortung, dass die nachfolgend benannten 
Produkte den grundlegenden Anforderungen und Bestimmungen 

der Verordnung (EU) 2017/745 für Medizinprodukte entsprechen 
und gemäß der Anhänge II, III und VIII (Regel 1,13) der Risikoklasse I 
zugeordnet werden:

Produktnamen:
Pfl egebett AURA
Pfl egebett IMPULSE

Pfl egebett AYLEEN

Basis UDI-DI: 4065848MALSCH-PKL00002V  

Die bezeichneten Produkte wurden unter Anwendung der folgenden 
Richtlinien und harmonisierten Normen produziert:

Elektrische Sicherheit: 

IEC 60601-1 A2:2019

Mechanische Sicherheit: 

IEC 60601-2-52:2009+A1:2015

EMV: 

IEC 60601-1-2:2014

Gebrauchstauglichkeit:

IEC 60601-1-6:2010+A1:2013
IEC 62366-1:2015+COR1:2016

Risikomanagement: 

DIN EN ISO 14971:2020-07

Richtlinie zur Beschränkung gefährlicher Stoff e RoHS

Richtlinie 2011/65/EU

Durch die Einhaltung der Bestimmungen der Verordnung (EU) 017/745 

werden die Anforderungen zur Anbringung einer CE-Kennzeichnung 
erfüllt. Aufgrund der Spezifi kation als Medizinprodukt Klasse I werden 
Produkt und Verpackung spätestens ab Mai 2025 zusätzlich mit einer 
UDI-Kennzeichnung versehen. Eine Konformität der Produkt- und 
Entwicklungsdokumentation sowie des QM-Systems wird durch die 
Zertifi zierung nach DIN EN ISO 13485:2016 bestätigt.

Bei einer mit uns nicht abgestimmten Änderung des oben 

genannten Produktes verliert diese Er klärung ihre Gültigkeit.    

EN

EC Declaration of Conformity

in accordance with Regulation (EU) 2017/745 of the European Parlia-
ment and of the Council of 5 April 2017 concerning medical devices, 
Annex IV.

The manufacturer

Betten Malsch GmbH
Rohbergstraße 9
36208 Wildeck-Obersuhl, Germany

Phone  +49 (0) 6626 915-100
Fax 

+49 (0) 6626 915-116

declares under its sole responsibility that the devices named below 

comply with the essential requirements and provisions of Regulation 
(EU) 2017/745 for medical devices and are assigned to risk class I in 
accordance with Annexes II, III and VIII (Rule 1.13):

Product names:
Care bed AURA
Care bed IMPULSE

Care bed AYLEEN

Basic UDI-DI: 4065848MALSCH-PKL00002V

The designated products have been produced in application of the 
following directives and harmonised standards:

Electrical safety: 

IEC 60601-1 A2:2019

Mechanical safety: 

IEC 60601-2-52:2009+A1:2015

EMC: 

IEC 60601-1-2:2014

Usability:

IEC 60601-1-6:2010+A1:2013
IEC 62366-1:2015+COR1:2016

Risk Management: 

DIN EN ISO 14971:2020-07

Directive on the Restriction of Hazardous Substances RoHS 

Directive 2011/65/EU

By complying with the provisions of Regulation (EU) 2017/745, 

the requirements for affi  xing a CE marking are fulfi lled. Due to the 
specifi cation as a medical device class I, the product and packaging will 
additionally be provided with a UDI marking from May 2025 at the 
latest. Conformity of the product and development documentation 
as well as the QM system is confi rmed by certifi cation according to 
DIN EN ISO 13485:2016.

In the event of a modifi cation of the above-mentioned product 

not agreed with us, this declaration loses its validity.

EU

-K

E-

40

658

48

M

A

LS

C

H

-P

K

L0

00

02

V_

D

E-

EN

_R

2.

7

Wildeck, den 23.04.2021

Rayk Malsch
Geschäftsführer / CEO / Gérant

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...

Reviews: