ISKOmed Rotadorm Vario User manual

Rotadorm Vario
Instruction for use
Stand: 08/2022
(Rev. 3.0)

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Content
1 Foreword ......................................................................................................................................... 4
2 General notes.................................................................................................................................. 5
2.1 Used symbols........................................................................................................................... 5
2.2 Type plate................................................................................................................................ 7
2.3 Standards verification........................................................................................................... 8
3 Safety instructions........................................................................................................................... 9
4 General product description ......................................................................................................... 10
4.1 Intended purpose.................................................................................................................. 10
4.2 Indication............................................................................................................................... 10
4.3 Contraindication.................................................................................................................... 10
4.4 Equipment features............................................................................................................... 11
5 Assembly information ................................................................................................................... 12
5.1 Basic information for assembly............................................................................................. 12
5.2 Dimensional sketch of the movement space ........................................................................ 12
5.3 Mounting the bed in bed system in the existing bed surround............................................ 13
5.4 Mounting the pull handle...................................................................................................... 15
5.5 Disassembling the care bed................................................................................................... 15
6 Operation ...................................................................................................................................... 16
6.1 Locking function .................................................................................................................... 16
6.2 Operating the functions ........................................................................................................ 16
6.3 Operating the turning function ............................................................................................. 17
6.4 Patient lifting pole with handle............................................................................................. 18
6.5 Operating instructions........................................................................................................... 19
6.6 Mattresses approved for use ................................................................................................ 20
7 Ambient conditions ....................................................................................................................... 20
7.1 Storage conditions................................................................................................................. 20
7.2 Operating conditions............................................................................................................. 21
8Technical data................................................................................................................................ 21
9 Used materials............................................................................................................................... 22
10 Service and care ........................................................................................................................ 22
11 Service life of the product ......................................................................................................... 22
12 Disinfection................................................................................................................................ 22
12.1 Specifications of detergents and disinfectants ..................................................................... 22
13 Operational faults and solutions............................................................................................... 23

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14 Recommended accessories ....................................................................................................... 24
15 Maintenance.............................................................................................................................. 25
15.1 Legal basis.............................................................................................................................. 25
15.2 Maintenance intervals........................................................................................................... 25
15.3 Spare parts............................................................................................................................. 25
15.4 Notes on documentation ...................................................................................................... 26
16 Reuse......................................................................................................................................... 26
17 Disposal ..................................................................................................................................... 26
17.1 Disposal of the device............................................................................................................ 26
17.2 Disposal of the electrical components .................................................................................. 26
17.3 Disposal of the packaging...................................................................................................... 26
18 Declaration of Conformity......................................................................................................... 27
List of figures
Figure 1: Exemplary type plate................................................................................................................ 7
Figure 2: Dimensional sketch of the movement area of the Rotadorm Vario...................................... 12
Figure 3: Adjustable foot for positioning the Rotadorm Vario.............................................................. 13
Figure 4: Minimum distance between the turnstile and the side edge of the bed .............................. 14
Figure 5: Lateral minimum distance between lying surface frame and bed surround......................... 14
Figure 6: Sequence for mounting the access instead of the mattress support bracket ...................... 15
Figure 7: Removable patient handle ..................................................................................................... 16
Figure 8: Locking box............................................................................................................................. 16
Figure 9: Patient hand control............................................................................................................... 17
Figure 10: Get up position..................................................................................................................... 17
Figure 11: Patient lifting pole mount at the head end.......................................................................... 18
Figure 12: Adjustable grab handle ........................................................................................................ 19
List of tables
Table 1: Used symbols............................................................................................................................. 7
Table 2: Standards verification................................................................................................................ 8
Table 3: Dimensions to the dimensional sketch of the movement space ............................................ 13
Table 4: Storage conditions................................................................................................................... 20
Table 5: Operating conditions............................................................................................................... 21
Table 6: Technical data.......................................................................................................................... 21
Table 7: Operational faults and solutions ............................................................................................. 23
Table 8: Recommended accessoires ..................................................................................................... 24

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1Foreword
Dear customer!
We would like to thank you for the trust you have placed in us and for purchasing our product. We
have manufactured this medical product with great care.
Please read the instructions for use carefully before using the product for the first time and always
keep them close at hand.
Not all conceivable uses of the device can be covered in these instructions for use. For further
information or in the event of problems that are not described in sufficient detail in these instructions
for use, please contact your specialist dealer or medical supply store.

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2General notes
2.1 Used symbols
This warning sign indicates all instructions that
are important for safety.
Non-observance can lead to accidents or
injuries.
Manufacturer - Indicates the manufacturer of
the medical device according to EU Directives
2017/745.
The symbol must appear in close proximity to
the symbol, together with the name and address
of the manufacturer (i.e. the person who places
the medical device on the market)
Conformity symbol according to 2017/745 of the
Medical Devices Directive
Medical Device - Shows the medical device
provided by the manufacturer in accordance
with EU Directives 2017/745
Device type B according to IEC 601-1
(Special protection against electric shock)
Device of protection class II, protective
insulation
Dispose of electrical components in accordance
with the legal requirements. Do not dispose of in
household waste!
Date of manufacture - indicates the date when
the medical device was manufactured.
Part number - displays the manufacturer's part
number so that the medical device can be
identified.
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Serial number - displays the manufacturer's
serial number so that a specific medical device
can be identified.
Distributor - indicates the company that
distributes the medical device at the location.
Temperature Limit - indicates the temperature
limits to which the medical device can be safely
exposed.
Humidity, Limit - indicates the humidity range to
which the medical device can be safely exposed.
Air Pressure, Limit - indicates the range of air
pressure to which the medical device can be
safely exposed.
Observe instruction for use or electronic
instruction for use - indicates to the user that it
is necessary to observe the instruction for use.
Unique identifier of a medical device - displays a
carrier containing information about a unique
identifier of a medical device.
Safe working load
Max. patient weight

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Minimum body dimensions/weights of the
patient
Table 1: Used symbols
2.2 Type plate
The type plate is attached to the head of the trolley frame. The nameplate allows the product to be
clearly identified.
Figure 1: Exemplary type plate
Figure 1 shows an exemplary type plate. For the exact specifications of your product, please refer to
the attached type plate.

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2.3 Standards verification
The following national and international norms (standards) are used in the design and verification of
the product, labeling and instructions for use.
Standard
Title
Edition
DIN EN 60601-2-52
Medical electrical equipment - Part 2-52: Particular
requirements for the safety of medical beds
12/2010
DIN EN 60601-1-6
Serviceability specification
2010
EN 60601-1-2
Electromagnetic compatibility
2015
DIN EN ISO 10993
Biological evaluation of medical devices - Part 1:
Assessment and testing
2010
DIN EN 1041
Provision of information by the manufacturer of a medical
device
2008
DIN EN ISO 14971
Medical devices - Application of risk management to medical
devices
2020
Table 2: Standards verification

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3Safety instructions
•Before operating the bed, you should read this instruction for use carefully (see Medical
Devices Operator Ordinance under your national law). It contains important information for
the safe and reliable use of the device. Keep the instruction for use for future reference.
•Safety, reliability and performance are guaranteed if the following instructions are observed
and the device is used in an expert manner. As the operator, you must comply with the Medical
Devices Operator Ordinance under your national law.
•The beds are suitable for both home care (application environment 3, 4), here a maximum
patient weight of 135 kg must be observed.
•Ensure that children only have access to the bed undersupervision and that no children remain
in the danger zone under the bed during its operation.
•The bed should only be set up by authorized personnel.
•The fuse protection on the installation side must not exceed 16A. Before connecting the
device, please make sure that the voltage and frequency of your power supply correspond to
the specifications on the type plate.
•Ensure a level standing surface when selecting the location for the bed.
•Provide a suitable floor covering if the bed must be moved frequently. Carpets, rugs and
loosely laid floor coverings can be damaged or make it difficult to push.
•Connect the power plug firmly to the power socket. When doing so, lay the power supply cable
on the floor. Make sure that the bed (especially when moving) does not rest on the cable with
its castors. The cable must not be routed through the mechanics of the base! (danger of
crushing)
•Damaged power cables can lead to life-threatening situations. These must be replaced
immediately.
•Check the power cable for damage at regular intervals (weekly).
•Make sure that the electrical specifications of the device correspond to the local conditions at
the installation site.
•When the hand control is not in use, make sure that it is hanging on the bed and not placed in
the bed to prevent incorrect operation which could cause damage.
•If the patient is unattended, ensure that the bed is set at its lowest height to allow the easiest
possible entry and exit.

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4General product description
4.1 Intended purpose
The Rotadorm Vario is a medical device that can lead to the patient's renewed
participation in his environment and minimize physical stress for both the patient
and the caregiver.
4.2 Indication
The Rotadorm Vario is an aid whose use is indicated:
•for people who are unable to get up or mobilize themselves independently in bed and sit on
the edge of the bed
•to enable people to get up independently
•to enable independent transfer from bed to wheelchair
•to enable and support getting up in case of severely limited mobility or strain on the lumbar
spine and joints
•for mobilization in case of extreme pain symptoms during passive movement
•in case of extensor spasticity caused by passive movement (e.g. MS)
•for people for whom the caregiver must be physically relieved in home care in order to make
home care possible and ensure it in the long term
•for insured persons who are no longer spontaneously mobile, especially patients with QS
symptoms, with a greatly increased risk of developing a pressure sore, or for the further
treatment of an existing pressure sore
•in case of tetraplegia or advanced muscular dystrophy with preserved residual function of the
legs, especially if regular changes of position of the upper body and legs are required
•for self-mobilization after stroke
•for seated positioning, e.g. in case of cardiac insufficiency
The indication for the turning bed applies to all illnesses or disabilities in which the patient is unable to
perform the movement sequence of getting up from lying to sitting with or without assistance due to
his joints, low muscle strength or pain - or in which the assisting person is physically overloaded, e.g.
due to his own illness.
4.3 Contraindication
In case of decubitus especially in the hip and leg area
•In case of extreme deformation and non-weight-bearing capacity of the lower extremities
•In case of massive cardiovascular problems
•In case of severe dizziness, which makes it impossible to stand up independently or partially
independently.
•In case of severe anxiety
The caregiver must make sure that the user is mentally capable of handling an electrically adjustable
care bed. Otherwise, all electrical functions on the bed must be switched off using the key switch and
the hand control must also be secured against access by the patient.

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4.4 Equipment features
The Rotadorm Vario has the following electrical functions
-Electrical height adjustment
-Electrical head adjustment
-Electrical neck adjustment
-Electrical knee adjustment
-Electrical leg adjustment
-Electrical turning function
The drives for the adjustment functions consist of electromechanical linear motors with maintenance-
free permanent lubrication. The drives are operated via a hand switch, which is connected to the
control unit via a spiral cable. The bed has four single-braked castors.
The drives and the hand switch are galvanically isolated from the mains voltage and are operated with
a low voltage (DC 24 V).
With a turning bed, the patient's personal space of action is maintained over a long period of time. The
user can move and care for himself freely.
The stand-up function of the lying surface can be adjusted by the service staff specifically to the needs
of the patient. A selection of the direction of rotation to the left or right is possible.

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5Assembly information
5.1 Basic information for assembly
The bed should only be assembled by authorised personnel. The fuse on the installation side must not
exceed 16A.
Before connecting the device, please ensure that the voltage and frequency of your mains supply
correspond to the specifications on the type plate.
Ensure that the bed is placed on a level surface when selecting its location.
Connect the mains plug firmly to the mains socket. When doing so, lay the mains connection cable on
the floor. When doing so, ensure that the bed (especially when moving) is not standing with its castors
on the cable. The cable must not be fed through the mechanics of the bed base! (danger of crushing)
Damage to the electrical mains cable by running over it or clamping it can have fatal
consequences.
Before moving the bed or dismantling it for transport, the mains connection cable must be
wound up and secured to the intended device on the chassis.
5.2 Dimensional sketch of the movement space
For the rotating function of the lying surface, it is essential to keep the following space free for
movement outside the nursing bed.
Figure 2: Dimensional sketch of the movement area of the Rotadorm Vario
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Type
SI-011-EB
Measure A*)
195 cm
Measure B*)
85 cm
Measure C
195 cm
Measure D
85 cm
Measure E
30 cm
Measure F
50 cm
Table 3: Dimensions to the dimensional sketch of the movement space
No objects, pieces of furniture or walls may interfere with the turning function within the
specified range of motion. (Danger of crushing)
5.3 Mounting the bed in bed system in the existing bed surround
The product is designed for installation in standard beds or bed surrounds. The existing bed surround
should be stable in itself. No forces or loads are transferred from the installation frame to the surround.
The wooden surround is fixed to the installation frame, which stands firmly on the floor. When setting
up, the following points must be observed. Internal dimensions (clearances) of the existing bed
surround should be at least 90 cm x 200 cm. This also applies to the required floor clearance.
Accordingly, the installation frame also requires a dimension of 90 cm x 200 cm for ground clearance.
The required floor clearance of 90 x 200 cm excludes some variants of bed base. Those that are
equipped with crossbars or a metal border.
When placing the frame, make sure that it is centered. There should be an even distance to all four
sides - but at least 2.5 cm on each side. This is most easily determined in the lowest position of the
frame.
After adjusting the frame in the existing bed, any unevenness of the floor must be compensated for
using the adjustable feet (Pos. 1, Figure 3). Turning to the right raises the chassis, whereas turning to
the left lowers the chassis. The installation frame must stand firmly on the ground. The required ground
clearance of the leveling feet is 82 cm x 150 cm.
Fixing to the existing wooden border is done on the left and right with the side brackets (Pos. 2, Figure
5). Minimum distance: 2.5 cm. The side angles are connected to the wooden edging at a height of
approx. 20 cm. Use the enclosed wood screws for screwing. The wall thickness of the wooden panel
should be at least 10 mm. The side angle is only used for fixing and does not have to absorb any forces.
In order to avoid collisions or shearing off between the turning cross (pos. 3, Figure 4) and the wooden
border (pos. 5, Figure 4) during the turning process of the lying surface, for safety reasons the side
boards, in the lowest position of the lying surface, must be mounted at least 3.0cm below the upper
edge of the fixed metal frame (pos. 4, Figure 4)
If there is a bed base in the existing bed, it must be removed.
Figure 3: Adjustable foot for positioning the Rotadorm Vario
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Figure 4: Minimum distance between the turnstile and the side edge of the bed
The side boards of thewooden surround of the existing bed must under no circumstances
protrude over the rectangular tubes of the lying surface frame that has been moved all
the way down. Danger of collision during the turning process! Minimum distance 3.0cm!
(cf. Figure 4)
It is essential to maintain a safety distance of 2.5 cm between the existing wooden
surround and the metal frame of the installation frame.
Figure 5: Lateral minimum distance between lying surface frame and bed surround
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5.4 Mounting the pull handle
When mounting the pull handle, the mattress holder mounted on the head side must be removed. To
do this, loosen the screw connection and insert the pull handle in the existing holes. The standard
screws can be used for reattachment. (cf. Figure 6)
Figure 6: Sequence for mounting the access instead of the mattress support bracket
The pull handle may only be used as a traction aid for lateral positioning.
Do not use the handle as a grip aid when getting in and out of bed.
5.5 Disassembling the care bed
If necessary, for example for transport, the care beds can be easily dismantled as described, but in
reverse order. Re-assembling the bed after dismantling should only be done by authorized personnel.
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6Operation
Figure 7: Removable patient handle
The patient handle is used to hold or support the patient during the standing-up process. It is only
intended for use during the standing-up process. The handle must be screwed tight via the grub screws
and must also have latched pull latches. (cf. Figure 7)
Retaining brackets must always be properly mounted when in use.
6.1 Locking function
All turning beds are equipped with a safety shut-off system. The integrated lockout knob allows the
user to lock or unlock the electrical functions directly on the locking box.
Figure 8: Locking box
6.2 Operating the functions
All electrical functions are operated by the manual push buttons. Each button is labelled according to
its function.
If necessary, an authorized dealer can adapt all the functions of the motor movements exactly to your
wishes or care requirements and set the individual positions of the lying surface and store them in the
electronic control of the program sequence.
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Figure 9: Patient hand control
6.3 Operating the turning function
When using the swivel function, the lying surface automatically moves into a suitable position to allow
the user to get out of the bed easily (cf. Figure 10).
Figure 10: Get up position
When the button "Get up in" is pressed, the bed goes from the sitting-standing up position back into
the lying position, while the footrest remains slightly raised and does not go completely into the
horizontal position.
Pressing the button "Get up out":
•The height motor drives to a preset height as starting position for turning
•The knee bend and headrest motors drive at the same time to a predefined sitting position,
whereby the legs lie over the edge of the bed and the seat back is inclined around 45º to the
rear.
•Then a further drive turns the lying surface to angle of 90º to the chassis
•After the 90° position has been reached, the height of the lying surface is corrected upwards
•Then the kneebend and the headrest simultaneously bring the lying surface to the standing
up position

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•Finally, the neck support is raised to make it easier to get out of bed, then the swivel process
is completed
Pressing the button "Get up in":
•The height motor drives up into the preset starting position to turn back.
•The knee bend and head rest motors simultaneously go into a predefined sitting position (see
above)
•Once it has arrived in the sitting postion, the lying surface turns back parallel to the chassis
•The knee bend and head rest motors simultaneously drive into the lying position, while the
head rest remains somewhat raised and does not completely drive back into the horizontal
position.
Keep the buttons pressed until the turning process has completely ended.
(No more noise can be heard from the motors)
6.4 Patient lifting pole with handle
There is a mounting for the lifting pole on both sides of the lying surface at the head of our care beds.
When fitting the lifting pole, ensure that lifter tube with the metal bolt is pushed far enough into the
socket bushing so that the metal bolt is fully located in the recessed slot on the socket bushing. Thus
the lifting pole is fixed in its position and can not be swung out over the lying surface (cf. Figure 11)
The included grab handle is used for the user to stand upright and can be individually adjusted to the
correct height with the webbing.
Figure 11: Patient lifting pole mount at the head end
The lifter is not suitable for therapeutic purposes.
The maximum load capacity of the lifter is 75 Kg
The metal bolt on the lifter tube must always be located in the recess slot. Danger of toppling
over!
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Check the grab handle and the webbing strap for damage at regular intervals. Damaged parts
should be changed immediately!
The grab handle which is delivered is designed to assist the user to sit up and can be individually
adjusted to the correct height with the webbing strap and the adjusting buckle (cf. Figure 12). The
range of adjustment is from 670mm to 870mm. (Measured without mattress)
Figure 12: Adjustable grab handle
6.5 Operating instructions
•After the bed has been assembled and before it is used by a patient, check that all
connections and the whole bed itself are firmly secured.
•Check that all drives are working faultlessly.
•If a care bed is not fully capable of functioning, it should be taken out of use immediately.
•Make sure that there are no objects such as waste paper bins, side tables, chairs etc. in the
movement space of the bed.
•In order to avoid the risk of injury, it is not permitted for any part of the patient’s body to
protrude out from the lying surface, nor for feet to rest on the bed underframe when
operating the adjustment functions.
•Before moving the bed, the mains plug should be removed from the socket in order to avoid
damage to the electrics.
•When there is a patient in the bed, the maximum height of a threshold over which the bed
can be pushed is 2 cm.
•Make sure to maintain the duty cycle. Never make lengthy and unnecessary electrical
adjustments. Once the thermal protection switch in the control unit has been triggered after
6 min/h, the control unit has to be replaced by an authorized specialist!
The installation of ancillary equipment such as insulin pumps, ventilators etc. is not
permitted unless equipotential bonding has been made in advance.
The cables for any ancillary equipment must not be led under the base of the bed! (Danger
of crushing)
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6.6 Mattresses approved for use
This bed is intended to be used with a divided, fire retardant mattress according to DIN 13014 and DIN
597, with a minimum volume weight of 35 Kg/m³ (RG35), a compression resistance of min. 4.2 kPa, a
maximum height of 12 cm, a minimum width of 88 cm and a minimum length of 197 cm (mattress and
foot block together).
For safety reasons, a distance of 22 cm must be maintained between the upper edge of the
mattress (unloaded) and the upper edge of the uppermost wooden side rails (side rails in
upper position).
Mattresses with high volume weights are only permitted if the weight of the mattress and
the patient combined does not exceed the safe working load of the bed.
7Ambient conditions
According to DIN EN 60601-2-52, the medical device can be used in the following application
environment:
Application environment 3:
Long-term care in a medical setting where medical supervision is required and monitoring is provided
as necessary; an ME device may be provided for a medical procedure to maintain, improve, or support
the patient's condition.
Application environment 4:
ME device to alleviate or compensate for an injury, disability or illness in home care.
A maximum noise level of 49 dB (A) occurs during adjustment of the electric drives.
7.1 Storage conditions
Storage conditions
min. -10 °C max. +50 °C
Relative humidity
min. 20 % max. 80 %
Air pressure (at altitude ≤3000
m)
min. 700 hPa max. 1060 hPa
Table 4: Storage conditions
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