Malsch Impulse KL, Impulse 300 KL, Impulse 400 KL, Impulse XL KL User Manual
CLINIC DESIGN
IMPULSE KL SERIES
INSTRUCTIONS FOR USE
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Dear Customers,
By purchasing a clinical 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 standards of safety.
We would like to thank you for the trust you have placed in us.
Our company guarantees carefully selected materials and
continuous 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 clinical bed.
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CONTENTS
Specific function 7
Environmental Sustainability 7
Note regarding the
instructions for use 8
Pictograms / Symbols 8
Safety instructions 9
Technical Data 12
Rating Plate 13
Symbols on the patient’s hand controller 14
Symbols on the nurse’s control panel 15
Product designation 16
Functional representation 17
Description of function 18
Back rest 18
Mechanical release of the
Back rest (CPR) 18
Upper leg section 18
Height adjustment 18
Transfer position 19
Low position/
Fall prevention 19
Comfort sitting position 19
Auto contour 19
Trendelenburg-/
Anti-Trendelenburg position 20
Hand controller locking function 20
Braking and moving 21
Side rail (SR) adjustment 22
Integrated lying surface extension 23
Removable head / foot boards 24
Delivery and assembly 25
Accessories (optional) 26
Trapeze bar 26
Intravenous drip holder 26
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Bed light 26
Hand controller holder 27
Horizontal hand controller 27
Mattresses 27
Side rail heightening 27
Urine bottle / bag / basket 28
5th wheel 28
Trouble shooting 30
Product safety 31
Cleaning and disinfection 32
Maintenance 33
Storage 33
Warranty and service 34
Declaration of conformity 34
Certificates 35
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Room representation
Impulse 300 KL / Impulse 400 KL
SPECIFIC FUNCTION
ENVIRONMENTAL SUSTAINABILITY
Betten Malsch GmbH clinical beds are used in hospitals and
care areas. These beds are designed exclusively for this purpose. The comfort and functionality of the clinical beds make
life easier for staff as they carry out the tasks involved in patient care, and they aid compensation positioning and relief of
disabilities for treated patients in hospitals and care facilities.
If the clinical beds are used for other applications, then
prior written agreement from Betten Malsch GmbH is
required.
The product should be used as a working appliance and care
aid, and is subject to the insurance association’s regulations.
With regard to industry standards and regulations, the clinical
bed is a medical device. Therefore, this product should only be
used under medical supervision.
The clinical beds described in this instruction manual are
intended for adult patients 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
beds must not be used by patients whose body weight
and height do not meet these limits, or who have a BMI
under 17, as the risk of injury is significantly increased
for this group.
Caution! The use of incompatible side rails and
mattresses can lead to injury as body parts may
become trapped.
Betten Malsch GmbH clinical beds are manufactured in accordance with the relevant regulations, and in line with state
of the art process technologies, and are free from hazardous
materials. The materials used to finish surfaces are CFC and
solvent free.
Clinical beds that are removed from circulation due to age or
irreparable damage must be disposed of in accordance with
disposal regulations.
Caution ! When disposing of metal, wood and
electrical waste, please observe the relevant
local regulations.
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NOTE REGARDING THE INSTRUCTIONS FOR USE
PICTOGRAMS / SYMBOLS
The following instructions and guidelines in this manual are for
the nursing staff or other persons and staff tasked with using
and working with the clinical bed.
The instruction manual must be available to
users at all times in order to avoid any errors
in operation and to guarantee fault free operation. The nursing staff must have complete
knowledge of, and receive training on operation before using clinical beds for the first time.
The instruction manual is the basis for this.
The instruction manual is designed to apply to the Impulse KL
clinical bed range. The images, graphics and text it contains
may differ from the delivered equipment.
The manufacturer offers technician training for
maintenance and servicing work on their clinical beds. A certificate obtained as part of this
training authorises the holder to carry out technical work independently on the beds.
To help easy orientation in this instruction manual, we sometimes use pictograms as follows:
Please note! Instructions labelled in this way must
be followed in order to avoid injury or damage!
Information! This pictogram identifies information
which relates to the current subject!
Observe the instructions for maintenance and
repair work! We can supply you with special service instructions for accessories or complex maintenance instructions. You will find these at www.
bettenmalsch.de in the Service area.
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SAFETY INSTRUCTIONS
1. The instruction manual should be read and followed before using the clinical bed.
2. Explanation of the terms used on the rating plate.
CE: Conformity marking in accordance with Medical
Devices Directive
IPX6: Protection of electrical equipment from water spray
“only use in dry areas”
Protection Rating Class II (double insulation, pro-
tective insulation)
The instructions on the rating plate must be observed..
3. In the event of any fault or failing which could endanger
any person, the bed must not be used.
4. Only fully-trained specialists should operate electrically
operated clinical beds.
5. Before using the bed for the first time, the operator
should satisfy himself that it is safe to use and in a good
condition.
6. To ensure the patient does not fall when getting into or
out of the bed, the castors should always be placed in
the brake position.
7. The bed can be moved into various positions. When doing so, you must take care to ensure no parts of the body
or other objects are located in the adjustment area.
be taken to ensure that the patient does not come into
contact with the side rails when adjusting the lying position, to avoid trapping any part of the body.
9. The side rails must be taken down every day to check
their function, and should not bear any load of over 75
kg vertically or over 50 kg horizontally.
10. When using the mechanical emergency lowering of the
back rest (CPR), this must always also be held firmly to
avoid any sudden lowering.
11. The functions of the hand controller can be locked or
released via nurse’s control panel or by using the key
switch on the backside of the hand controller. The operation of the locking function should be checked on the
hand controller. F p.14/p.15
12. The power systems used must be operated using a VDE
approved power source – 220 V, 50/60 Hz mains socket.
13. The mains connection lead is also protected by a mechanical strain relief. Care must also be taken to ensure
that there are no sharp edges, mechanical stresses or
pinch/shear points.
14. The design of the hand controller means it can be hung
on the bed in such a way that the buttons are not activated inadvertently between 2 objects. Care must be taken
to ensure that the hand controller is fully accessible and
not trapped between the side rail and bedside table.
8. Only nursing staff may adjust the side rails. Care should
15. When using the clinical bed in a patient’s room, safety
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distances between walls, window benches or other objects must be observed. Safety distances depend on the
design and model of the clinical bed and are based on
height adjustments and tilting motion. The minimum distance is 30 mm.
16. The following subjects and actions are considered to be
‘Improper Use’:
Unauthorised activation of the electrical functions
Use of the bed by children under 12 years old
Moving the bed by pulling the mains cable or side
rail
Simultaneous adjustment of the clinical bed by sev-
eral people
Activation of the functions by patients without prior
instruction
Pulling the mains cable to remove it from the elec-
tricity supply
Moving the bed on a sloping or insecure surface
It is important that the following safety instructions are observed to prevent the risk of danger or injury to both patient
and carer and also avoid any potential damage to the bed:
The mattress used must fulfill the applicable safety
standards
For safety reasons, the handle on the trapeze bar
should be replaced completely every 5 years.
Service and repairs on electrical components
should only be carried out using original replacement parts from the manufacturer and must be carried out by specially trained staff.
The clinical bed is not suitable for extended oper-
ation beyond the working cycle of 2 minutes. If the
mains adapter is overloaded or if it overheats, it will
shut off automatically. Further operation will then
only be possible after a cooling period of approx.
30 minutes. (Observe the drive manufacturer’s
notes on the rating plate!)
Obstruction any part of the bed mechanism must
be absolutely avoided, as this can lead to damage
or complete disabling of the drive mechanism due
to overheating.
Equally, the safe working load should not be ex-
ceeded.
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If an immobile patient remains in the same position
for a longer period without use of positioning aids,
this can lead to pressure sores. The manufacturer
of the clinical bed is not liable for this in any way.
Electrically powered clinical beds are medical
products and are subject to technical safety checks
in accordance with the Medical Devices Directive
and Medical Devices Operator Ordinance § 6.
These regular checks must be carried out at least
once a year. A visual and operational inspection
of functional and electrical safety in accordance
with VDE0751 must be carried out to ensure this.
p. 33 Maintenance
Furthermore, electrically operated clinical beds
are electrical appliances, the safety of which is
the responsibility of the employer. The supervisory
function of this obligation is the responsibility of the
Berufsgenossenschaft für Gesundheitsdienst und
Wohlfahrtspflege (Employers’ Liability Insurance
Association for Health Service and Welfare Work
- BGW) and the Gewerbeaufsichtsamt (Trade Supervisory Board). The regulations of the Employers’
Liability Insurance Association for Health Service
and Welfare Work apply (abbreviated to BGV, formerly VBG). In particular BGV A2 (formerly VBG)
“ Electrical Units and Equipment” applies, which
requires regular inspection of movable electrical
equipment with a guideline of 6 months but at least
once a year. These inspections may only be carried
out by an electrical specialist or someone with electrical training using a special measurement and
inspection device. Inspections in accordance with
BGV A2 within the technical safety checks for med-
ical products may be carried out be specialist staff
trained by the manufacturer as these BGV inspections are included in the technical safety checks.
Electrically operated clinical beds are active medi-
cal products and must be listed in an inventory per
site in accordance with the Medizinprodukte Betreiberverordnung (MedProd-BetrV) Medical Products
Operation Regulations. We recommend you also
document the proper implementation of the required technical safety checks in this inventory and
note the date of the next inspection. The required
notes on technical safety checks already carried out
should be appended to the inventory.
Proper execution and traceable documentation of
the technical checks, maintenance and commissioning work prescribed by the manufacturer, as
well as the technical safety checks are required in
order to preserve the warranty right of the purchaser. If the operator of a medical product does not
meet their obligations, then this may lead to a risk
of damage and accidents, for which the manufacturer is explicitly not liable.
Any maintenance work is to be carried out in ac-
cordance with VDE0751-1 and the subsequent
technical safety check is to be documented.
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