Ormed ARTROMOT-K3 User manual

Operation Manual
ARTROMOT®-K3
DIN EN 13485 ORMED Nr. 018 829-01
© ORMED 6/04
ORMED GmbH & Co. KG • Merzhauser Straße 112 • D -79100 Freiburg
Phone [phone] • Fax [phone] • 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]

Device description
Fold out this page
1 2
1 Knob for femur length adjustment
2 Base
3 Coiled cord
4 Controller cable
5 Hand-held controller
6 Knurled knob for length adjust-
ment of lower leg
7 Power adapter
8 On/Off switch
9 Knurled knob for angle of foot
inclination
10 Footplate with patient kit
11 Socket for power adapter
12 Knurled knob for rotating foot
plate
13 Kit straps
14 Lower leg patient kit
15 Knee pivot point
16 Thigh patient kit
12 13 1511
10 9
14
81256
15 16
347

The ARTROMOT®-K3 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®-K3 is
mainly used in the avoidance of immo-
bilization injuries, the early re-establish-
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 metabolism
- the prevention of joint stiffness
- the promotion of the healing of
cartilage areas and damaged ligaments
- the speeding up of haematoma
resorbtion
- the improvement of lymph and blood
circulation
- the prevention of thrombosis and
embolism
4
1. How to use ARTROMOT®- K3
1.3. Indications1.1. Application
1.2. Objectives of thera py
The ARTROMOT®-K3 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
- mobilizations of joints in narcosis
- operative treatments on fractures,
pseudarthrosis and inversion
operations
- criciate ligament replacement surgery
(ACL/PCL)
- endoprothetic implants
Contents
1. How to use ARTROMOT®-K3 4
1.1. Application 4
1.2. Objectives of therapy 4
1.3. Indications 4
2. Description of the ARTROMOT®- K3 5
3. Safety instructions 6
4. Adjusting the device 7
4.1 Connecting the device 7
4.2. Adjusting the femur length 7
4.3. Adjusting the supports 7
5. Setting the treatment values 8
5.1. Programming the ARTROMOT®-K3 8
5.1.1. Programming the treatment values 8
5.1.2. Information about treatment values 8
5.1.3. Programming the special functions 9
6. Maintenance 10
7. Specifications 10
8. Service 11
9. Declaration of conformity 12
10. Figures 17
3
CAUTION!
The ARTROMOT®-K3 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

6
2. Description of the ARTROMOT®- K3
Explanation of functioning elements
The ARTROMOT®-K3 CPM device
allows extension and flexion of the
knee joint in the range of –5-0-110
degrees. There is no need to convert
the device when switching from the
right to left side (or vice versa).
The ARTROMOT®-K3 features a
hand-held programming unit that can
be used to program and store any
treatment values.
5
3. Safety instructions
- The ARTROMOT®-K3 may only be
operated by authorized persons.
- Make sure that the patient is supported
in an anatomically correct way. Check
the following settings/ positioning:
1. Femur length
2. knee joint axis
3. calf length and leg rotation setting
4. 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 wether 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
correspond to the voltage and
frequency data indicated on the ID
plate.
- Only connect the ARTROMOT®-K3
to correctly installed safety sockets.
-Repair and maintenance work may
only be carried out by authorized
persons, as otherwise all warranty
services and liabilities shall be void.
- Perform regular checks on all com-
ponents for possible damage or loose
connections
- Damaged or worn parts should be
replaced immediately with original
spare parts by an authorized specialist.
- 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.
CAUTION!
these instructions must be read
before start- up!
CAUTION!
Before treatment begins, a test run
involving several movement cycles
should be carried out first without
and then with the patient.
Note: Fold out page 1
1 Knob for femur length adjustment
2 Base
3 Coiled cord
4 Controller cable
5 Hand-held programming unit
6 Knob for length adjustment of
lower leg
7 Power adapter
8 Main switch
9 Knob for angle adjustment of foot
inclination
10 Foot plate with patient kit
11 Socket for power adapter
12 Knob for rotation footplate
13 Kit straps
14 Lower leg patient kit
15 Knee pivot point
16 Thigh patient kit
Explanation of symbols
Alternating current
Protective system Type B
Power off
Power on
Device off
Device on
CAUTION!
The ARTROMOT®-K3 may only be
operated with the attached power
supply NTEV20

87
- Fix patient kit (14) for the lower leg
and patient kit (16) 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.
- Connect the power adapter (7)
to a safety socket (120 Volt, 60 Hertz)
- Turn on the device with the main
switch (8)
Set the device at a knee-angle position
that is not likely to cause the patient
any pain.
Positioning the upper leg
- Open the black knurled knob (1),
and move thigh support to the
desired length (figure 2)
Positioning the lower leg
- Loosen the two knobs (6), 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 (9) and adjust
the foot plate at a comfortable angle.
(figure 4)
Positioning of foot rotation
- Loosen the knurled knob (12) and
move the foot plate into the required
rotation position. (figure 5)
4. Adjusting the device
4.3. Adjusting the
patient kit
4.1. Connecting
the device
4.2. Adjusting the femur
length
Note: Fold out pages 1 and 17
To get a better understanding of the
individual steps.
CAUTION!
The knee and hip axis of the
ARTROMOT®-K3 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.
2. You can now select the treatment
values in succession 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: programmed
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: -5 degrees
- Maximum knee flexion: 110 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 or flexion and can be set
separately for extension and flexion.
- Possible values for pauses: 0 –30
seconds
5.1.2. Information about
treatment values
CAUTION!
The programmed value and the
actual angle measured at the
patient´s knee may vary.
The following treatment values can be
stored by means of the hand-held
programming unit. (5)
- Knee extension
- Knee flexion
- Pause extension
- Pause flexion
- Force
- Speed
5.1.1. Programming the
treatment values
5.1. Programming the
ARTROMOT®-K3
5. Setting the treatment values
IMPORTANT:
It is possible to program single or all
parameters. If only some parameters
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.
Fig. 1
Buttons to
choose the
parameters:
Extension
Flexion
Pause
Extension
Pause
Flexion
Force
Speed
Display
STOP
START
“SET“
“+“ button
“–“ button
Function

109
Warm-up allows the patient to attain
gradually full programmed range of motion.
The device starts in the middle between
the two values set for extension and fle-
xion. 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 faci-
litate a rapid device set up.
WARNING: Do not run the device in
full speed & motion when patient is in
the device!
This is the individual run time for each
treatment. 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 approximate!
Tensile force is measured on the frame
around the foot.
The input setting determines the maxi-
mum resistance needed to automati-
cally 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 functions using
+ or –key
4. Follow the instructions on the display
5. Quit and save with STOP button
CAUTION!
The reverse circuit is purely a
safety measure for cramps,
spasms, locked joints, etc.
The manufacturer accepts no
liability if used improperly.
5.1.3. Programming the
special functions
Center warm-up
Full speed & motion
Run time
Device run time
Save data
CAUTION!
Never allow liquids to get inside
the housing or hand-held
programming unit.
6. Maintenance
- Always unplug the device before
cleaning
- The ARTROMOT®-K3 can be wiped
clean with disinfectant 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, oxidizing 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 +50OF to +104OF
Relative humidity 30% to 75%
Air pressure 700hPa to 1060 hPa
Electrical rating 115/230V~
50/60Hz
15V/27VA
Input current 0.3 Amps
Rated 1.33 A
Transformer Safety transformer
EN 60742
Protection class II
Length 36.6 inches/93 cm
Width 14 inches/36 cm
Height 16.53 inches without
foot plate/43 cm
Length adjustment
for lower leg 16.7 inches/42,5cm
(approximate length) –22 inches/56 cm
Length adjustment
for upper leg 2.75 inches/7 cm
(approximate length)
Weight 24.4 lb./ 11.8 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: 115/230V ~
50/60 HZ 27VA
Out: 15V ~ 1.33A
Manufacturer:
Ulmer
7. Specifications

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]
CAUTION!
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.
8. Service
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, Germany
1211
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®-K3
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 1 and 2,
additional norm: electromagnetic compatibility –
requirements and testing
The adherence to the standard specifications
entitles to marking of these devices with CE 0297.
Freiburg, January 20, 2002
Quality Control Manager
DECLARATION OF CONFORMITY
0297

14
NotesNotes
13

15
Notes
16
Notes

17
Figures
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18
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8