Ormed ARTROMOT-K4 User manual

Operation Manual
ARTROMOT®-K4

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Device description Figures
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8

The ARTROMOT®-K4 is a motor-
operated motion device used for
Continuous Passive Motion (CPM)
of the knee and hip joints.
Suitable for use in hospitals, clinics,
general practices and rental services, it
is an important supplement to medical
and therapeutic treatment.
CPM therapy with ARTROMOT®-K4 is
mainly used in the avoidence of immo-
bilisation injuries, the early reestablish-
ment of painless movement of joints
and the promotion of faster healing with
a positive functional result.
Other objectives of therapy include:
– the improvement of joint meatbolism
– the prevention of joint stiffness
– the promotion of the healing of car-
tilage areas and damaged ligaments
– the speeding up of haematoma
resorbtion
– the improvement of lymph and blood
circulation
– the prevention of thrombosis and
embolism
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The ARTROMOT®-K4 CPM device
is indicated in the treatment of most
injuries, postoperative states and
diseases of the knee and hip joint.
For example:
– joint distorsions and contusions
– arthrotomy and arthroscopy
procedures in combination with
synovectomy, arthrolysis or other
intra articular measures
– mobilsations of joints in narcosis
– operative treatments on fractures,
pseudarthrosis and inversion opera-
tions
– criciate ligament replacement surgery
(ACL/PCL)
– endoprothetic implants
Device description 2
Figures 3
1. How to use ARTROMOT®-K4 5
1.1 Application 5
1.2 Objectives of therapy 5
1.3 Indications 5
2. Description of the ARTROMOT®-K4 6
3. Safety instructions 7
4. Adjusting the device 8
4.1 Connecting the device
4.2 Adjusting the femur length 8
4.3 Adjusting the patient kit 8
4.4 Conversion 9
5. Setting the treatment values 10
5.1 Programming the ARTROMOT®-K4 10
5.1.1 Programming the treatment values 10
5.1.2 Information about treatment values 10
5.1.3 Programming the special functions 11
6. Maintenance 12
7. Specifications 12
8. Service 13
9. Declaration of conformity 14
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Contents 1. How to use ARTROMOT®-K4
1.1 Application
PRECAUTION!
The ARTROMOT®-K4 should not
be used with:
–acute inflammatory processes
in the joint area, if not explicitly
prescribed by the doctor
–spastic paralysis
–unstable osteosynthesis
Movement should not cause any
pain.
1.3 Indications
1.2 Objectives of therapy

7
The ARTROMOT®-K4 CPM device
allows extension and flexion of the
knee joint in the range of -10-0-125
degrees and of the hip joint in the range
of 10-100 degrees.
The ARTROMOT®-K4 features a
hand-held programming unit that can
be used to program and store any
treatment values.
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– The ARTROMOT®-K4 may only be
operated by authorised persons.
– Make sure that the patient is sup-
ported in an anatomically correct way.
Check the following settings/posi-
tioning:
1. Femur length
2. Knee joint axis
3. Hip joint axis
4. Calf length and leg rotation setting
5. Patient kits
– In case of patients who are adipose,
particular large or very small, you
should pay attention to the following:
– Avoid abrasion and pressure
– If necessary support the leg in a
slightly abductive position.
– The maximum continuous load on the
leg support element is 30 kg.
– Movement must always be free of
pain and irritation.
– The patient must be fully conscious
during instruction and when using the
splint.
– The doctor or therapist must decide
on a case-to-case basis whether the
device can be used with the patient.
– The hand-held programming unit
should be explained to the patient
and must be located within the
patient’s reach, so that the therapy
can be interrupted if necessary.
– Make sure that the characteristic
values of your power supply corre-
spond to the voltage and frequency
data indicated on the ID plate.
– Only connect the ARTROMOT®-K4
to correctly installed safty sockets.
–Repair and maintenance work may
only be carried out by authorised
persons, as otherwise all warranty
services and liabilities shall be void.
– Perform regular checks on all compo-
nents for possible damage or loose
connections.
– Damaged or worn parts should be
replaced immediately with original
spare parts by an authorised spe-
cialist.
–
Before cleaning and repair disconnect
the device from the main socket.
– When carrying out any work on the
device, never allow liquids to get
inside the housing or the hand-held
programming unit.
– Only use the AC-AC adapter supplied
with the unit.
To disconnect the device from mains,
unplug the AC-AC adapter from the wall
socket.
Note: Fold out page 2
1 Button for heigth adjustment of hip
pivot point
2 Spare tube
3 Release tubes for square tube
4 Patient kit strapes
5 Coiled cord
6 Controller cable
7 Hand-held programming unit
8 Knob for length adjustment
of lower leg
9Base
10 Knob for angle adjustment of foot
inclination
11 Knob for rotation footplate
12 Power adapter
13 Cable of power adapter
14 Socket for power adapter
15 Main switch
16 Footplate with patient kit
17 Lower leg support
18 Lower leg patient kit
19 Knee pivot point
20 Thigh patient kit
21 Thigh support
22 Knob for femur length adjustment
23 Hip axis pivot point
Explanation of symbols
Alternating current
Protective system Type B
Power off
Power on
Device off
Device on
2. Description of the ARTROMOT®-K4
Explanation of the functioning
elements
3. Safety instructions
PRECAUTION!
these instructions must be read
before start-up!
PRECAUTION!
Before treatment begins, a test
run involving several movement
cycles should be carried out first
without and then with the patient.
PRECAUTION!
The ARTROMOT®-K4 may only be
operated with the attached power
supply NTEV20.

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– Fix patient kit (18) for the lower leg
and patient kit (20) for the upper leg
by using the velcro tapes (figure 6
and figure 7).
– Control correct adjustment. Exercise
only in painfree range of motion.
Patient should be positioned with
maximum comfort.
Note: Fold out pages 2 and 3.
To get a better understanding of the
individual steps.
– Connect the power adapter (7) to a
to a safety socket (120 Volt, 60 Hertz)
– Turn on the device with the main
switch (15)
Set the device at knee-angle position
that is not likely to cause the patient
any pain.
Positioning the upper leg
– Open the black knurled knob (22),
push button and move thigh support
(21) to the desired length (figure 2).
– For correct alignment of the hip axis
pivot point (23) and anatomical hip
axis of the patient pull button (1) and
align pivot point (23) to height of
trochanter major of the patient.
Positioning the lower leg
– Loosen the two knobs (8), move the
foot support horizontally and adjust
precisely to the patients lower leg
length (figure 3).
Positioning of foot dorsi-/plantar
flexion
– Loosen the two knobs (10) and adjust
the foot plate at a comfortable angle
(figure 4).
Positioning of foot rotation
– Loosen the knurled knob (11) and
move the foot plate into the required
rotation position (figure 5).
ARTROMOT®-K4 features a true
anatomical knee and hip axis for
maximum patient comfort.
ARTROMOT®-K4 has to be set up
either for the right or left leg.
The device can be converted quickly.
The procedure is easiest at an angle
of approximatly 80–90 degrees
(section 5.1.1).
– Hand-held programming unit (7) is in
STOP mode.
– Pull button for height adjustment
mechanism (1) and remove thigh
support (21) (figure 9).
– Hold the thigh support. Release
length adjustment mechanism
(1/4 rotation) from the bayonet lock
(figure 10).
Remove entire part and slide into
the opposite side and fix in place with
the bayonet lock.
– Press buttons (3) simultaneously and
pull square tube (2) associated with
the heigth adjustment mechanism out
from profile (figure 11). Slide into the
opposite profile until it “clicks” home
audibly.
– Slide the height adjustment elements
together again and allow hinge to
click home at the same height as the
turning point of the hip (figure 12).
Fig.12
Fig. 9
4.1 Connecting
the device
4.2 Adjusting the
femur length
4. Adjusting the device
4.3 Adjusting the
patient kit
PRECAUTION!
The knee and hip axis of the
ARTROMOT®-K4 should align with
the patients knee and hip axis
(figure 8).
After adjustments have been
made, perform several test runs.
When correctly adjusted, there
should be no excursion of the
knee and hip joint during motion.
4.4 Conversion
Fig.10
Fig.11
PRECAUTION!
For correct insert and lock posi-
tion of the bayonet lock refer to
sticker on the device.

The following treatment values can
be stored by means of the hand-held
programming unit. (7)
– Knee extension
– Knee flexion
– Pause extension
– Pause flexion
– Force
– Speed
IMPORTANT:
It is possible to program single or all
parameters. If only some parametres
were changed, the other parameters
will be saved with current settings.
1. Pressing the Extension and STOP
keys at the same time for one
second or holding down the STOP
key for five seconds enables you to
change to programming mode.
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Warm up allows the patient gradually
attain full programmed range of motion.
The device starts in the middle between
the two values set for extension and
flexion. With each movement cycle the
extent of movement is increased by
2 degrees until the set value is reached.
The device then moves between these
values.
The full speed & motion function is only
for service.The device runs at twice
the maximum programmable speed to
facilitate a rapid device set up.
WARNING: Do not run the device in
full speed & motion when patient is
in the device!
The individual run time for each treat-
ment.To reset press SET key in the
programming mode.
The total device run time is counted
from the first usage of the device. Press
+button for 5 seconds until setting
appears. Device run time cannot be
deleted.
To save the programmed special func-
tions, press the STOP key.
Press the START key: the device checks
programmed values.
Adjusting the force (reverse on load)
– Minimum setting for reverse on load:
25 kp
– Maximum setting for reverse on load:
45 kp
Settings are aproximate!
Tensile force is measured on the frame
around the foot.
The input setting determines the maxi-
mum resistance needed to automatical-
ly reverse the direction of motion.
Speed
Minimum setting for speed: 1%
Maximum setting for speed: 100%
Special functions are:
– Center warm up
– Full speed & motion (double speed
setting)
– Runtime (patient runtime)
– Device runtime
Programming the special functions:
1. Switch to programming mode
(section 5.1.1)
2. Press FUNC key
3. Select special funtions using
+or -key
4. Follow the instructions on the display
5. Quit and save with STOP button
2. You can now select the treatment
values in succesion by pressing the
parameter keys.
3. Change the value by pressing the
+/- keys.
4. Continue programming (with 2 and 3)
until all required values are entered.
5. Press the STOP key to save all
previous values.
6. Press START button: programme
values were checked automatically.
7. Press START button again to start
the device in therapy mode.
8. Pressing the parameter buttons
in stop mode the display shows the
current stored values.
Setting the range of motion ROM
–
Maximun knee extension: -10 degrees
– Maximum knee flexion: 125 degrees
The criterion for correct adjustment is
that it should be possible to move the
extremity without pain or irritation.
Adjusting the pauses
– The pauses occur in the final position
of extension of flexion and can be set
seperately for extension and flexion.
– Possible values for pauses:
0–30 seconds.
Fig.1
Buttons to
choose the
parameters:
Extension
Flexion
Pause
Extension
Pause
Flexion
Force
Speed
Display
STOP
START
“SET“
“+” button
“–” button
Function
5. Setting the treatment values
5.1 Programming the
ARTROMOT®-K4
5.1.1 Programming the
treatment values
5.1.2 Information about
treatment values
PRECAUTION!
The programmed value and
the actual angle measured at the
patient´s knee may vary.
Center warm up
Full speed & motion
Run time
Device run time
Save data
PRECAUTION!
The reverse circuit is purely a
safty measure for cramps,spasms,
locked joints, etc. The manufac-
turer accepts no liability if used
improperly.
5.1.3 Programming the
special functions

Electrical rating 115 V/230 V~
50/60 Hz
15 V/27 VA
Input current 0.3 Amps
Rated 1.33 A
Transformer Safety transformer
EN 60742
Protection class II
Length 45.27 inches/115 cm
Width 15.5 inches/39.5 cm
Height 21.7 inches/55 cm
Length adjustment
for lower leg 15.5 inches/39.5 cm
-22 inches/56 cm
Length adjustment
for upper leg 12.5 inches/32 cm
(approximate length) -19.7 inches/50 cm
Weigth 26 lb./13 kg
Materials used Steel: 1.4301;
1.4305; 1.4310
Aluminium: AlMg3;
AlCuMgPb F38,
Brass
Synthetic material:
PA6.6; Polystyrol
PVC; PE 1000;
FR4 Electronic
board;
Polyurethane;
rubber
Support: synthetic
fleece (Polyester)
Technical data subject to change
MPG: Class 2a
Power supply NTEV20
Safety Transformer
In:115/230 V~
50/60 HZ, 27 VA
Out:15 V~ 1.33A
Manufacturer:
Ulmer
– Always unplug the device before
cleaning
– The ARTROMOT®-K4 can be wiped
clean with desinfectant and therefore
complies with the required standards
of hygiene for medical equipment.
– The housing can be cleaned using
commonly available disinfectants and
mild household detergents.
– The device itself should only be wiped
down with damp cloth.
– The plastics used are not resistant
to mineral acids, formic acid, phenol,
cresol, oxidising or strong organic
and inorganic acids with a pH value
of less than 4.
– Protect the device from intensive
ultraviolet radiation (sunlight).
Surrounding Conditions
Surrounding
temperature -11OF to +140OF
Relative humidity 20% to 85%
Air pressure 700hPa to 1060 hPa
Operational Conditions
Surrounding
temperature +50O F to +104OF
Relative humidity 30% to 75%
Air pressure 700hPa to 1060 hPa
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6. Maintenance 7. Specifications
PRECAUTION!
Never allow liquids to get inside
the housing or hand-held pro-
gramming unit.
If you have any questions regarding
product or service, please do not
hesitate to contact us:
ORMED international
Please contact your local dealer or
Headquarters Germany
ORMED GmbH & Co. KG
Merzhauser Straße 112
D-79100 Freiburg, Germany
Tel. [phone]
Fax [phone]
e-mail: [email protected]
USA, St. Paul
Tel. [phone]
Fax [phone]
e-mail: r[email protected]
Czech Republic, Prague
Tel. [phone]
Fax [phone]
e-mail: miroslav[email protected]
Internet:
www.ormed.de
e-mail: [email protected]
www.ormedusa.com
Technical hotline:
Do you have any technical questions?
Do you need Technical service?
Tel. [phone]-ormed.de
[phone]
Fax [phone]-ormed.de
[phone]
To avoid transport damages, use only
the original packing boxes. These
boxes can be ordered from Ormed.
Before carrying the device, always
make sure the femur length adjustment
is locked.
Maintenance:
Not necessary
Guarantee:
2 years warranty on mechanical and
electronical parts
Manufacturer:
ORMED GmbH & Co. KG
Merzhauser Straße 112
D-79100 Freiburg
8. Service PRECAUTION!
Carry out regular checks at short
intervals for possible damage and
loose connections. Damaged or
worn parts should be replaced
immediately with original spare
parts by an authorized specialist.

Declaration of Conformity
According to the EC-Regulation for medical devices the
EC Medical Devices Directive (MDD) 93/42/EEC dated 14th June 1993,
appendix 2
The Manufacturer
ORMED GmbH & Co. KG
Merzhauser Straße 112
D-79100 Freiburg
herewith declares that the following units
Type Knee & Hip
Name ARTROMOT®-K4
meets all requirements of following EC-directives:
EN 60 601-1 1990 Electrical Medical Devices, Part 1, Basic Rules
for Safety
EN 60 601-2 1993 Electrical Medical Devices, Part 1and 2,
additional norm: electromagnetic compatibility –
requirements and testing
The adherence to the standard specifications
entitles to marking of these devices with CE 0297.
0297
Freiburg, January 20, 2002
Quality Control Manager
DECLARATION OF CONFORMITY
DIN EN 46 001 ORMED Nr. 018 829-01
© ORMED 4/03
Ormed GmbH & Co. KG • Merzhauser Straße 112 • D-79100 Freiburg • Phone ++49(0)761/4566-281
Fax ++49(0)761/4566-55 281 • www.ormed.de • e-mail: [e-mail]
St.Paul/USA,Phone [phone],Fax [phone] • Prague/CR,Phone [phone],
Fax [phone] • Vienna/A, Tel [phone], Fax [phone]
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