Malsch AYLEEN CARE BED User manual

CARE DESIGN
AYLEEN CARE BED
INSTRUCTION MANUAL

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DEAR CUSTOMERS,
By purchasing a care bed from Malsch care & clinic design®, you
have obtained a long-lasting medical product 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 contin-
uous quality control while employing state-of-the-art production
technologies.
Complying with the usage and operating instructions helps to
prevent the risk of accidents and preserves the high value of your
care bed.

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Product range 6
Specic function 7
Environmental sustainability 7
Notes regarding the instruction manual 8
Pictograms/symbols 8
Safety instructions 9
Technical data 14
Electric drives 15
Rating plate 16
Rating plate with UDI 16
HC-147 hand controller symbols 19
Function illustration 20
AYLEEN care bed with undercarriage
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
Mechanical back 24
rest release /CPR 24
Adjustable thigh/lower leg rest 25
Auto contour 25
Height adjustment 25
Hand controller locking function 25
Braking and moving 26
DS side rail adjustment 28
Maintenance 30
Battery replacement 32
Maintenance intervals 33
Delivery and assembly 33
Disposal instructions 34
CONTENTS

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Accessories (optional) 35
Lifting pole 35
IV drip holder 35
Bedside light 35
Hand 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 and service 41
Customer service 41
Declaration of conformity 41
Certicates 42

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PRODUCT RANGE
AYLEEN care bed with undercarriage
Edition 400 HC
AYLEEN care bed with undercarriage
Edition XL
AYLEEN care bed with undercarriage
Edition 400 N
AYLEEN care bed with undercarriage
Edition 500

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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 ir-
reparable 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 asso-
ciations. The care bed is a medical device with reference to appli-
cable industry standards and regulations. Therefore, this product
must only be used under medical supervision.
The care beds described in this instruction manual are intend-
ed 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

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NOTES REGARDING 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 AYLEEN care
bed. 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 in-
dependently 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.

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SAFETY INSTRUCTIONS
It is important that the following safety instructions are ob-
served 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 pla-
te! The information on the rating plate is explained in detail
on p. 16 „Rating plate“ of this instruction manual.
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 AYLEEN care bed features a battery-operated emer-
gency mode. This allows the one-o lowering of the sleep-
ing surface in the event of a power cut. To ensure this func-
tionality, we recommend an annual test of the 9 V batteries
as part of the technical safety check and regular battery
replacement every two years or after each emergency low-
ering. p. 32 „Battery replacement“.
The hand controller functions can be locked or released on
the rear side using the key switch. Check that the locking
function has taken eect on the hand controller. p. 19
„HC-147 hand controller symbols“.
The drive system used must be operated using a VDE-ap-
proved power source – 100–240V, 50/60Hz mains socket.
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, me-
chanical loads or pinch/shear points.

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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. 7 „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 sleep-
ing 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, since this can lead to damage or even complete fail-
ure of the drive system due to overheating.
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-

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tioning aids, this can lead to pressure sores. The manufactur-
er of the care bed is not liable for this in any way.
Electrically operated care beds are active medical devic-
es and must be maintained according to Article 7 of the
German Medical Device Operator Ordinance (MedProd-
BetrV). These maintenance measures must be carried out
regularly (at least once per year). This must involve visual
and operational inspections of functional and electrical safe-
ty in line with VDE0751. p. 30 „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 tech-
nical checks, maintenance and servicing work prescribed
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 explicitly 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 oper-
ation.
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.
When using other ME devices in conjunction with the care
bed, precautions must be taken to prevent damage to the

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device cable or other components of the ME device result-
ing 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) – in-
cluding their accessories, such as antenna cables and ex-
ternal 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 device 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 ob-
struct anyone from disconnecting the mains plug.

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*measured from sleeping surface frame
TECHNICAL DATA
Model Dimensions
[cm]
Sleeping surface
[cm]
Height
adjustment
[cm]
Weight Safe
working load
Thigh rest
adjustment
Back rest
adjustment
AYLEEN care bed
with undercarriage
Edition 400HC
100x 206 90x 200 40 to 80
*Approx. 120kg
Total 180 kg
145 kg resident
20 kg mattress
15 kg accessories
33°
71°/ 12 cm
Mattress com-
pensation
AYLEEN care bed
with undercarriage
Edition 400N
100x 206 90x 200 27 to 81
*Approx. 120kg
Total 180 kg
145 kg resident
20 kg mattress
15 kg accessories
33°
71°/ 12 cm
Mattress com-
pensation
AYLEEN care bed
with undercarriage
Edition XL
110x 216 100x 200 38 to 78
*Approx. 160kg
Total 300 kg
250 kg resident
25 kg mattress
25 kg accessories
33°
71°/ 12 cm
Mattress com-
pensation
AYLEEN care bed
with undercarriage
Edition 500
90x 200 90x 200 33 to 78
*Approx. 100kg
Total 180 kg
145 kg resident
20 kg mattress
15 kg accessories
33°
71°/ 12 cm
Mattress com-
pensation

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ELECTRIC DRIVES
Model Edition 400HC /400N /500 XL
Electrical connection 100- 240VAC 50/60Hz
Output voltage: 35VDC 2 A 35VDC 2.5 A
Over-current o 7.5–11.5A DC
Over-voltage o 45 V DC
Standby operation Max. 0.5 W
Protection IPX4
Protection class II
Lifting system force
Lifting system force 1x 6000N 2x 6000N
Sleeping surface adjustment force 2x 4000N 4x 4000N
Motor running time on 2 max. /o 18 min.
Data on operation, transport and storage
Operating temperature range +10° C to +40°C
Transport/storage temperature range +5° C to +50°C
Relative humidity 30% to 75 %
Atmospheric pressure range 700 hPa to 1,060hPa
Operating volume 54dB (A)
Operating altitude Max. 3,000 m

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Malsch
Malsch GmbH | Rohbergstraße 9 | D-36208 Wildeck-Obersuhl
Tel.: [phone] | Fax: [phone]
R 3.1.2
Made in Germany
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2024
Input:
Output:
Operation:
Protection class:
Care bed AYLEEN
0422 400HC 1234567 180 kg
145 kg 300 kg
100-240V AC 50/60 Hz 2.1-0.9 A
35 V DC 2/2.5 A
max. T_on: 2 min.
min. T_o: 18 min.
IPX4
Input:
Output:
Operation:
Protection:
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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
145 kg
180 kg
300 kg
(01)4065848000106
(21)012104001234567
(240)0320018015121410
Care bed AYLEEN
Malsch
Malsch GmbH | Rohbergstraße 9 | D-36208 Wildeck-Obersuhl
Tel.: [phone] | [e-mail] | bettenmalsch.com
R 3.2
Made in Germany
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1
RATING PLATE
RATING PLATE WITH UDI
Example of a rating plate without UDI of the AYLEEN care bed
Example of a rating plate with UDI of the AYLEEN care bed

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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 ex-
ample, 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 resi-
dent (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

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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 siz-
es depending on the sleeping surface dimensions:
Mattress size [cm] Sleeping surface
dimensions [cm]
Volumetric weight
[kg/m³]
78 x 200 x 12/14 80 x 200 *35 - 50
88 x 200 x 12/14 90 x200 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

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485 C
355 C
Pantone Cool Gray 11C
Pantone Cool Gray 3C
S1
Back rest up
S2
Back rest
down
S3
Thigh rest up
S5
Auto contour
up
S7
Height adjust-
ment up
S4
Thigh 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 the back of the hand controller to restrict
operation by residents.
p. 25 „Hand controller locking function“

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10
9
8
7
5
4
21 361. Footboard
2. Adjustable lower leg rest
3. Adjustable thigh rest
4. Static seat section
5. Adjustable back rest
6. Receiving sleeve for IV drip holder
and accessories (4 x surrounding the
bed)
7. Full-length side rail
8. Release button for full-length side rail
9. Lower leg rest adjustable ratchet
10. 100 mm single castors with castor
brake
FUNCTION ILLUSTRATION
AYLEEN care bed with undercarriage Edition 400 HC
Design with full-length side rails (DS)
Edition 400 HC do not come with side panels!