Malsch IMPULSE User manual

IMPULSE |AURA
CARE BEDS INSTRUCTION MANUAL
CARE DESIGN

2 |

|3
Dear Customers,
By purchasing a care bed from Malsch care & clinic design®, you
have obtained a long-lasting medical device with functions that
meet all the requirements of everyday care 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 conti-
nuous quality control while employing state-of-the-art production
technologies.
Complying with the usage and operating instructions helps to pre-
vent the risk of accidents and preserves the high value of your
care bed.

4 |
IMPULSE care bed product range 6
AURA care bed product range 7
Specic function 8
Environmental sustainability 8
Note on the instruction manual 9
Pictograms/symbols 9
Safety instructions 10
IMPULSE care bed technical data 14
IMPULSE care bed electrical drives 15
AURA care bed technical data 16
AURA care bed electrical drives 17
Rating plate 18
Rating plate with UDI 18
HC-146 hand controller symbols 21
HC-147 hand controller symbols 23
HB-400 hand controller symbols 24
HB-400 hand controller symbols (6-button version) 25
Function illustration 27
IMPULSE care bed with undercarriage Edition 400 27
IMPULSE care bed with undercarriage Edition 400ZB 28
IMPULSE care bed with undercarriage Edition 400LR 29
IMPULSE care bed with undercarriage Edition 420 30
IMPULSE care bed with undercarriage Edition 420LR 31
IMPULSE care bed with undercarriage Edition 500 32
IMPULSE care bed with undercarriage Edition XL 33
AURA care bed 34
AURALR care bed 35
Description of function 36
Back rest 36
Mechanical back rest release / CPR 36
Adjustable thigh / lower leg rest 37
Auto contour 37
Height adjustment 37
Transfer position 38
CONTENTS

|5
Low position / fall prevention 38
Trendelenburg position 38
Reverse Trendelenburg position 39
Automatic chair position 39
Hand controller locking function 40
Braking and moving 41
Adjust DS side rails 44
Adjustment of side rails GS 46
Adjustment of side rails VGS1 48
Adjustment of side rails EVGS 49
VGS side rail dimensions 50
Dierent lengths of the GS and VGS side rails 51
Integrated bed extension 52
Maintenance 54
Procedure 54
Battery replacement 56
Maintenance intervals 57
Delivery and assembly 57
Disposal instructions 58
Accessories (optional) 59
Lifting pole 59
IV drip holder 59
Bedside light 59
Hand control holder 60
Integrated bed linen holder 60
Troubleshooting 61
Product safety 62
Cleaning and disinfection 63
Safe decommissioning/ storage 64
Electromagnetic compatibility (EMC) 65
Warranty and service 68
Customer service 68
Declaration of conformity 68
Certicates 69

6 |
IMPULSE CARE BED PRODUCT RANGE
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 400 ZB
IMPULSE care bed with undercarriage
Edition 420 LR
IMPULSE care bed with undercarriage
Edition 400 LR
IMPULSE care bed with undercarriage
Edition 500

|7
AURA CARE BED PRODUCT RANGE
AURA care bed AURA LR care bed

8 |
ENVIRONMENTAL SUSTAINABILITY
Malsch GmbH care beds are manufactured in line with the rel-
evant regulations using state-of-the-art processing technologies,
and contain no hazardous materials. The materials used to nish
surfaces are CFC- and solvent-free.
Care beds that are taken out of service due to their age or
irreparable damage must be disposed of in line with local disposal
regulations.
Caution! Please observe the relevant local regula-
tions when disposing of metal, wood and electrical
waste.
The care beds made by Malsch GmbH are used in the care indus-
try for patients with physical limitations. The beds are designed
exclusively for this purpose. The functions of these care beds assist
the care sta in their daily work and oer convenient solutions for
positioning the patient and compensating for certain symptoms
experienced by patients of retirement 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 the
care beds are to be used for other applications.
The product is intended for use as a care aid or health device.
As such, it is subject to the regulations of the relevant insurance
associations. The care bed is a medical device with reference to
applicable industry standards and regulations. Therefore, this pro-
duct must only be used under medical supervision.
The care beds described in this instruction manual are inten-
ded for adult residents with a body weight of at least 40kg and
a height of at least 146cm. In accordance with standard IEC
60601-2-52:2009/ AMD1:2015, the beds must not be used by
residents whose 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.
Caution! The use of incompatible side rails and mat-
tresses can lead to injury as body parts may become
trapped.
SPECIFIC FUNCTION

|9
NOTE ON THE
INSTRUCTION MANUAL
PICTOGRAMS / SYMBOLS
The following directions and statutory requirements in this in-
struction manual are intended for care sta or other persons and
sta tasked with operating and using the care bed.
The instruction manual must be accessible to per-
sonnel at all times to avoid operating errors and to
guarantee fault-free operation. The care sta must
have a good understanding of the care beds and be
trained in their operation before using them for the
rst time. The instruction manual must be used for
this training.
The instruction manual has been written for the IMPULSE and
AURA care beds. The images, graphics and texts it contains may
dier from the equipment supplied.
The manufacturer oers technician training for
maintenance and servicing work on their care beds.
A certicate obtained as part of this training au-
thorises the holder to carry out technical work
independently on the beds.
For better orientation, this instruction manual uses the picto-
grams described below.
Important!
Instructions labelled in this way must be strictly ob-
served in order to avoid injury or damage!
Information!
This symbol marks relevant information in its respec-
tive context.

10 |
SAFETY INSTRUCTIONS
It is important that the following safety instructions are obser-
ved to prevent risks to residents as well as carers, and to avoid
any damage to the bed:
The instruction manual must be read and observed before
using the care bed.
It is vital to observe the information given on the rating
plate! The information on the rating plate is explained in
detail on P. 18 of these instructions for use.
In the event of any faults or defects that could endanger a
person, the bed must not be used.
Electrically-adjustable care beds must only be operated by
the resident after instruction by trained sta.
Before the bed is used for the rst time, the operator must
be satised that it is safe to use and in good condition.
The castors must always be placed in the braked position to
ensure the resident does not fall when getting into or out of
the bed.
The bed can be moved into various positions. When doing
so, take care to ensure no objects or parts of the body are
located in the adjustment area.
Only care sta may adjust the side rails. When adjusting the
sleeping surface position, take care to ensure 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 75 kg vertically or over
50 kg horizontally.
When using CPR (optional, mechanical emergency lowering
of the back rest), always additionally relieve the load on the
back rest by hand to prevent the back rest dropping in an
uncontrolled manner.
The IMPULSE and AURA care beds that are equipped with
the hand controller HC-146/ HC-147 have a battery-ope-
rated emergency operation. This allows the one-o lowe-
ring of the sleeping surface in the event of a power cut. To
ensure this functionality with the above-mentioned congu-
ration, we recommend testing the 9V batteries annually as
part of the technical safety check and replacing the batteries
regularly every two years or after each emergency lowering.
P. 56 Battery replacement
The hand controller functions can be locked or released
on the rear side using the key switch (P. 21-23 hand
controller symbols HC-146 and HC-147) or using the mag-
netic chip on the front (P. 24 hand controller symbols
HB-400). Check that the locking function has taken eect
on the hand controller.
The drive system used must be operated using a VDE-appro-
ved power source 100 - 240V, 50 /60Hz mains socket.

|11
The mains connection cable must also be protected by
a mechanical strain relief device. Nevertheless, take care
to ensure that the cable is not damaged by sharp edges,
mechanical loads or pinch / shear points.
The hand controller can be placed exibly. When placing
the hand controller, take care to ensure that it cannot be
triggered accidentally (e.g. by being trapped between two
objects). The hand controller must be freely accessible.
Observe safety distances to walls, window ledges and other
furnishings when using the care bed in a resident’s room.
The safety distances depend on the design and model of the
care bed and are based on the height adjustment and the
tilting motions of the bed. The minimum distance is 30 mm.
Improper use of the bed may cause hazards. Examples of
improper use include:
§Unauthorised activation of the electrical functions
§Use of the bed by persons with a body weight of less
than 40 kg or a BMI of less than 17 or a height of less than
146 cm. P. 8 Specic function
§Moving the bed by pulling on the mains cable or side rails
§More than one person adjusting the bed at the same time
§Activation of the functions by the resident without prior
instruction
§Pulling the mains cable to disconnect it from the power
supply
§Moving the bed on sloping or unsurfaced ground
In accordance with IEC 60601-2-52:2009/AMD:2015, when
choosing a mattress, it is important that there is a minimum
distance of 22 cm between the top of the sleeping surface
and the top of the side rail in its fully extended position. The
mattress used must meet the applicable safety standards.
The constant presence of liquid in the area of the motor
must be avoided (e.g. incontinence).
For safety reasons, the grab handle on the lifting pole must
be replaced completely every 5years.
Servicing and repairs on electrical components must be car-
ried out by specially trained sta, and only original replace-
ment parts from the manufacturer may be used.
The care bed is not suitable for extended operation be-
yond a working cycle of 2minutes. If the mains adapter is
overloaded or if it overheats, it will shut o automatically.
Further operation is possible only after a 30-minute cool-
down phase. (Observe the drive manufacturer’s notes on
the rating plate!)
It is essential to avoid obstructing any part of the bed mech-
anism, as this can lead to damage or complete disabling of
the drive system due to overheating.

12 |
Likewise, the safe working load must not be exceeded.
If an immobile resident remains in the same position for an
extended period of time without the use of additional posi-
tioning aids, this can lead to pressure sores. The manufactu-
rer of the care bed is not liable for this in any way.
Electrically operated care beds are active medical devices
and must be maintained according to Article 7 of the Ger-
man Medical Device Operator Ordinance (MedProd-BetrV).
These maintenance measures must be carried out regularly
(at least once per year). This must involve visual and ope-
rational inspections of functional and electrical safety in line
with VDE0751. P. 54 Maintenance
Furthermore, electrically operated care beds are electrical
appliances and their safety is the responsibility of the em-
ployer. The supervisory function of this obligation is the re-
sponsibility of the Employers’ Liability Insurance Association
for Health Service and Welfare Work (BGW) and the Trade
Supervisory Board (Gewerbeaufsichtsamt). The regulations
of the employers’ liability insurance associations apply, par-
ticularly those of the German statutory accident insurance
body (DGUV), rule3 of which stipulates regular inspections
of movable electrical equipment at a recommended interval
of six months, but at least once a year. These inspections
may only be carried out by a certied electrician or person
with electrical training using specialist measurement and in-
spection equipment. The inspections according to DGUV
rule 3 can be conducted by specialist sta trained by 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 line with
Article 13 of the German Medical Device Operator Ordi-
nance (MedProd-BetrV). It is advisable to also document
the correct implementation of the required checks and
servicing in this inventory and to specify the date of the
next inspection. The required protocols concerning checks
already performed must be appended to the inventory.
Proper execution and traceable documentation of the
technical checks, maintenance and servicing work prescri-
bed by the manufacturer, as well as the technical safety
checks, are required in order to preserve the warranty
rights of the purchaser. If the operator of a medical device
does not meet their obligations, this could lead to the risk of
damage and accidents for which the manufacturer is expli-
citly not liable.
Maintenance work must be carried out and documented by
trained sta.
The bed must be left in the lowest position if the resident is
unattended in order to reduce the risk of injury caused by
falling out of bed.
If the mains connection cable is damaged, the bed can no
longer be used and must immediately be taken out of ope-
ration.
Improper use of the mains connection cable can result
in hazards (e.g. electric shock). Examples of this are cable
breaks due to kinking, shearing or other mechanical damage.

|13
When using other ME devices in conjunction with the care
bed, precautions must be taken to prevent damage to the
device cable or other components of the ME device resul-
ting from crushing between the movable parts of the medi-
cally used bed.
The care bed is not suitable for use in the vicinity of active
facilities that use high-frequency surgical devices.
The care bed is not suitable for use in HF-shielded rooms
used for magnetic resonance imaging in which high-intensity
EM disturbance variables occur.
The use of this care bed directly next to or in conjunction
with other electrical devices (e.g. stacked) must be avoided,
as this can lead to faulty operation. If using the bed in the
manner described above is absolutely necessary, the devices
involved should be subjected to a function test for a longer
period of time in order to rule out malfunction due to
interference.
The use of accessories, transducers and cables other than
those specied or provided by Malsch 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 devices (radio devices) – inclu-
ding their accessories, such as antenna cables and external
antennas – must not be used closer than 30 cm to the parts
and cables of care beds as designated by Malsch GmbH.
Non-observance can impair the performance of the care
bed.
The emissions of this device are below the thresholds de-
ned by IEC/ CISPR 11:2009, Class A and thus permit the
use of it in industrial environments and hospitals. This de-
vice may not provide adequate protection against wireless
services if used in residential areas (for which Class B is
normally required according to CISPR 11). The user may
have to implement remedial measures such as relocating or
repositioning the device.
Servicing and maintenance tasks may not be performed
while the ME device is in use.
The care bed must be positioned so that it does not obstruct
anyone from disconnecting the mains plug.

14 |
IMPULSE CARE BED TECHNICAL DATA
1measured from sleeping surface frame
Model Dimensions
[cm]
Sleeping
surface
[cm]
Height
adjustment
[cm]
1
Weight Safe working load Reverse /
Trendelenburg
position
Thigh rest
adjustment
Back rest
adjustment
IMPULSE care bed
with undercarriage
Editions
400/ 400 ZB
100x 206 90 x 200
25 to 82 Approx.
120kg
Total 225 kg
190 kg resident
20 kg mattress
15 kg accessories
17°/ 14° 33°
71°/ 12 cm
Mattress com-
pensation
90x 174.5 80 x 168.5
90x 186 80 x 180
90x 196 80 x 190
100x 196 90 x 190
90x 206 80 x 200
120x 206 110 x 200
130x 206 120 x 200
100x 226 90 x 220
IMPULSE care bed
with undercarriage
Edition 400LR
100x 206 90x 200 26 to 82 Approx.
120kg
Total 225 kg
190 kg resident
20 kg mattress
15 kg accessories
17°/ 14° 33°
71°/ 12 cm
Mattress com-
pensation
IMPULSE care bed
with undercarriage
Edition 420
100x 206 90 x 200
27 to 80 Approx.
100kg
Total 200 kg
165 kg resident
20 kg mattress
15 kg accessories
– 30°
71°/ 12 cm
Mattress com-
pensation
90x 206 80 x 200
IMPULSE care bed
with undercarriage
Edition 420LR
100x 206 90 x 200
28 to 81 Approx.
84kg
Total 200 kg
165 kg resident
20 kg mattress
15 kg accessories
– 30°
71°/ 12 cm
Mattress com-
pensation
90x 206 80 x 200
IMPULSE care bed
with undercarriage
Edition 500
100x 206 90 x 200
15 to 75 Approx.
136kg
Total 200 kg
165 kg resident
20 kg mattress
15 kg accessories
17°/ 14° 33°
71°/ 12 cm
Mattress com-
pensation
110x 206 100 x 200
IMPULSE care bed
with undercarriage
Edition XL
110x 206 100 x 200
33 to 83 Approx.
160kg
Total 300 kg
250 kg resident
25 kg mattress
25 kg accessories
17°/ 14° 33°
71°/ 12 cm
Mattress com-
pensation
110x 226 100 x 220
130x 206 120 x 200

|15
Model Edition 400
Edition 400ZB
Edition 400LR
Edition 420
Edition 420LR
Edition XL Edition 400
Edition 400ZB
Edition 400LR
Edition 420
Edition 420LR
Edition 500
Hand controller version HC-146 HC-147 HC-146 HB-400 HB-400 HB-400
Electrical connection 100- 240 V AC 50/ 60 Hz 100- 240 V AC 50/ 60 Hz
Output voltage 35V DC 2 A 35V DC 2.5 A – – –
Over-current o 7.5- 11.5 A DC 8ADC – – –
Over-voltage o 45 V DC – – –
Standby operation Max. 0.5 W Max. 0.8 W
Protection IPX4
Protection class II
Lifting system force
Lifting system force 2x 6000 N 1x 8000 N 2 x6000N 2x 6000 N 2x6000N 2x 8000 N
Sleeping surface adjustment force 2x 3,000 N 2x 4000 N 3 x3,000N 2x3,000N 2x 3,000 N Head 6000 N
Foot 3000N
Motor running time on 2 max. / o 18 min.
Data on operation, transport and storage
Operating temperature range +10°C to +40° C +5°C to +40° C
Transport / storage temperature range +5°C to +50° C -10°C to +50° C
Relative humidity 30% to 75 % 20% to 80 %
Atmospheric pressure range 700hPa to 1,060hPa
Operating volume 54dB (A)
Operating altitude Max. 3,000 m
IMPULSE CARE BED ELECTRICAL DRIVES

16 |
Model Dimensions
[cm]
Sleeping
surface
[cm]
Height
adjustment
[cm]1
Weight Safe working load Reverse /
Trendelenburg
position
Thigh rest
adjustment
Back rest
adjustment
AURA
AURA LR
92.5x 206 80 x 200
Approx.
25 (26
2)
to 82
Approx. 130kg
Total 225 kg
190 kg resident
20 kg mattress
15 kg accessories
17°/ 14° 33°
71°/ 12 cm
Mattress com-
pensation
102.5x 206 90x 200 Approx. 140kg
112.5x 206 100x 200 Approx. 150kg
122.5x 206 110x 200 Approx. 160kg
132.5x 206 120x 200 Approx. 170kg
AURA CARE BED TECHNICAL DATA
1measured from sleeping surface frame
2AURA LR

|17
Model AURA
AURA LR
AURA
AURA LR
Hand controller version HC-146 HB-400
Electrical connection 100- 240 V AC 50/ 60 Hz
Output voltage 35 VDC 2 /2.5A –
Over-current o 7.5 -11.5A DC –
Over-voltage o 45 V DC –
Standby operation Max. 0.5 W Max. 0.8 W
Protection IPX4
Protection class II
Lifting system force
Lifting system force 2x 6000 N
Sleeping surface adjustment force 2x 3,000 N
Motor running time on 2 min./ o 18 min.
Data on operation, transport and storage
Operating temperature range +10°C to +40° C +5°C to +40° C
Transport / storage temperature range +5°C to +50° C -10°C to +50°C
Relative humidity 30% to 75% 20% to 80 %
Atmospheric pressure range 700hPa to 1,060hPa
Operating volume 54dB (A)
Operating altitude Max. 3,000 m
AURA CARE BED ELECTRICAL DRIVES

18 |
Malsch
Malsch GmbH | Rohbergstraße 9 | D-36208 Wildeck-Obersuhl
Tel.: [phone] | Fax: [phone]
R 3.1.2
Made in Germany
N
E
X
T
I
N
S
P
E
C
T
I
O
N
12
3
4
5
67
8
9
10
11 12
2023
Input:
Output:
Operation:
Protection class:
Care bed IMPULSE
0422 40000 1234567 225 kg
190 kg 345 kg
100-240V AC 50/60 Hz 2.1-0.9 A
35 V DC 2 A
max. T_on: 2 min.
min. T_o: 18 min.
IPX4
Input:
Output:
Operation:
Protection:
12
3
4
5
67
8
9
10
11 12
N
E
X
T
I
N
S
P
E
C
T
I
O
N
2023
Care bed IMPULSE 100 - 240 V AC 50 / 60 Hz 2.1 - 0.9 A
35 V DC 2 A
max. 2 min. ON / 18 min. OFF
IPX4
190 kg
225 kg
345 kg
(01)4065848000014
(21)012104001234567
(240)0320018015121410
Malsch
Malsch GmbH | Rohbergstraße 9 | D-36208 Wildeck-Obersuhl
Tel.: [phone] | [e-mail] | bettenmalsch.com
R 3.2
Made in Germany
RATING PLATE WITH UDI
2
2
7
7
3
3
10
11
4
4
5
5
6
6
8
8
9
9
1
1
RATING PLATE
Example of a rating plate without UDI of the IMPULSE care bed with HC-146 hand controller
Example of a rating plate with UDI of the IMPULSE care bed with HC-146 hand controller

|19
The rating plate is located on the underside of the sleeping sur-
face, at the head of the bed on the right. To inspect the rating
plate, raise the back rest to the highest position.
Notes:
1. Manufacturer’s address
2. Model ID
3. Serial number
4. Electrical voltage; Frequency; Power consumption
5. Operating time of motorised adjustment: Please observe
this information to protect against overheating! In the
example, the drives of the bed are limited to a maximum
of 2minutes of continuous operation. If this limit is
reached, a regeneration period of 18minutes must be
observed before the drives can be operated again.
6. Protection of electrical 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 as a medical device
Application part type B
Directive 2012 / 19 / EU relating to old electrical and
electronic equipment
Conformity marking in line with the Medical Device
Directive (EU) 2017 / / 745
Protection class II
“Only use in dry areas”
“Observe the instruction manual”
9. Explanation of the weight icons used on the rating plate:
Safe working load
Maximum permissible weight of residents
Maximum total weight of the medical device incl
resident (bed weight plus maximum safe work load)
10. 2D barcode (GS1 data matrix) DI + PI = UDI
11. (DI) Device Identier
(01) UDI-DI / GTIN
(PI) Production Identier
(21) Serial number
(240) Additional product information

20 |
Labels
A separate sticker to the right of the rating plate refers to the
labels described below:
Symbol: Label indicating beds for adults used for medical pur-
poses in line with IEC 60601-2-52:2009/ AMD:2015
The care bed is approved for adult residents with a body weight
of at least 40 kg and a height of at least 146 cm. In accordance
with standard IEC 60601-2-52:2009 /AMD1:2015, the care bed
must not be used by residents whose 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 60601-2-52:2009/ AMD:2015 – please observe the infor-
mation and instruction manual for the mattresses!
The following table contains information concerning mattress
sizes depending on the sleeping surface dimensions:
Mattress size [cm] Sleeping surface
dimensions [cm]
Volumetric weight
[kg/m]
78 x 200 x 12 / 14 80 x 200 *35 - 50
88 x 200 x 12 / 14 90 x 200 35 - 50
98 x 200 x 12 / 14 100 x 200 *35 - 50
108 x 200 x 12 / 14 110 x 200 *35 - 50
118 x 200 x 12 / 14 120 x 200 *35 - 50
*Optional special sizes