ARTROMOT K3 Gebr Innen

ARTROMOT K3 Gebr Innen
ARTROMOT®-K3
Operation Manual
Device description
11 12
13
10
9
8
7
14
6
4
5
15
3
15
2
16
1
1
Knob for femur length adjustment
11
Socket for power adapter
2
Base
12
3
Coiled cord
Knurled knob for rotating foot
plate
4
Controller cable
13
Kit straps
14
Lower leg patient kit
15
Knee pivot point
16
Thigh patient kit
5
Hand-held controller
6
Knurled knob for length adjustment of lower leg
7
Power adapter
8
On/Off switch
9
Knurled knob for angle of foot
inclination
10
Footplate with patient kit
2
Contents
1. How to use ARTROMOT®-K3
1.1. Application
1.2. Objectives of therapy
1.3. Indications
4
4
4
4
2. Description of the ARTROMOT®- K3
5
3. Safety instructions
6
4. Adjusting the device
4.1 Connecting the device
4.2. Adjusting the femur length
4.3. Adjusting the supports
7
7
7
7
5.
8
8
8
8
9
Setting the treatment values
5.1. Programming the ARTROMOT®-K3
5.1.1. Programming the treatment values
5.1.2. Information about treatment values
5.1.3. Programming the special functions
6. Maintenance
10
7. Specifications
10
8. Service
11
9. Declaration of conformity
12
10. Figures
17
3
1. How to use ARTROMOT®- K3
1.1. Application
1.3. Indications
The ARTROMOT®-K3 is a motoroperated motion device used for
Continuous Passive Motion (CPM) of
the knee and hip joints.
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:
Suitable for use in hospitals, clinics,
general practices and rental services, it
is an important supplement to medical
and therapeutic treatment.
- joint distorsions and contusions
- arthrotomy and arthroscopy
procedures in combination with
synovectomy, arthrolysis or other
intra articular measures
1.2. Objectives of therapy
- mobilizations of joints in narcosis
- operative treatments on fractures,
pseudarthrosis and inversion
operations
CPM therapy with ARTROMOT®-K3 is
mainly used in the avoidance of immobilization injuries, the early re-establishment of painless movement of joints
and the promotion of faster healing with
a positive functional result.
- criciate ligament replacement surgery
(ACL/PCL)
- endoprothetic implants
Other objectives of therapy include:
- the improvement of joint metabolism
CAUTION!
- the prevention of joint stiffness
The ARTROMOT®-K3 should not
be used with:
- the promotion of the healing of
cartilage areas and damaged ligaments
- acute inflammatory processes in
the joint area, if not explicitly
prescribed by the doctor
- spastic paralysis
- the speeding up of haematoma
resorbtion
- the improvement of lymph and blood
circulation
- unstable osteosynthesis
- the prevention of thrombosis and
embolism
Movement should not cause any pain
4
2. Description of the ARTROMOT®- K3
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).
Explanation of functioning elements
1
Knob for femur length adjustment
The ARTROMOT -K3 features a
hand-held programming unit that can
be used to program and store any
treatment values.
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
Note: Fold out page 1
®
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
5
3. Safety instructions
- Make sure that the characteristic
values of your power supply
correspond to the voltage and
frequency data indicated on the ID
plate.
CAUTION!
these instructions must be read
before start- up!
- Only connect the ARTROMOT®-K3
to correctly installed safety sockets.
- 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:
- Repair and maintenance work may
only be carried out by authorized
persons, as otherwise all warranty
services and liabilities shall be void.
1. Femur length
- Perform regular checks on all components for possible damage or loose
connections
2. knee joint axis
3. calf length and leg rotation setting
4. patient kits
- Damaged or worn parts should be
replaced immediately with original
spare parts by an authorized specialist.
- In case of patients who are adipose,
particular large or very small, you
should pay attention to the following:
- Before cleaning and repair disconnect
the device from the main socket.
- Avoid abrasion and pressure
- If necessary support the leg in a
slightly abductive position
- When carrying out any work on the
device, never allow liquids to get
inside the housing or the hand-held
programming unit.
- The maximum continuous load on the
leg support element is 30 kg
- Only use the AC-AC adapter supplied
with the unit.
- Movement must always be free of
pain and irritation
- The patient must be fully conscious
during instruction and when using the
splint.
CAUTION!
The ARTROMOT®-K3 may only be
operated with the attached power
supply NTEV20
- The doctor or therapist must decide
on a case-to-case basis wether the
device can be used with the patient
To disconnect the device from mains,
unplug the AC-AC adapter from the wall
socket.
CAUTION!
Before treatment begins, a test run
involving several movement cycles
should be carried out first without
and then 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.
6
4. Adjusting the device
Note: Fold out pages 1 and 17
To get a better understanding of the
individual steps.
4.3. Adjusting the
patient kit
- 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)
4.1. Connecting
the device
- 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)
4.2. Adjusting the femur
length
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.
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)
7
5. Setting the treatment values
2. You can now select the treatment
values in succession by pressing the
parameter keys.
5.1. Programming the
ARTROMOT®-K3
3. Change the value by pressing the
+/- keys.
The following treatment values can be
stored by means of the hand-held
programming unit. (5)
4. Continue programming (with 2 and 3)
until all required values are entered.
5. Press the STOP key to save all
previous values.
- Knee extension
- Knee flexion
6. Press START button: programmed
values were checked automatically.
- Pause extension
7. Press START button again to start
the device in therapy mode.
- Pause flexion
- Force
8. Pressing the parameter buttons in
stop mode the display shows the
current stored values.
- Speed
Fig. 1
Buttons to
choose the
parameters:
Extension
Flexion
Pause
Extension
Pause
Flexion
Force
Speed
5.1.2. Information about
treatment values
Display
STOP
START
Setting the range of motion ROM
Function
“SET“
- Maximun knee extension: -5 degrees
“+“ button
- Maximum knee flexion: 110 degrees
“–“ button
CAUTION!
The programmed value and the
actual angle measured at the
patient´s knee may vary.
5.1.1. Programming the
treatment values
The criterion for correct adjustment
is that it should be possible to move
the extremity without pain or irritation.
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.
Adjusting the pauses
- The pauses occur in the final position
of extension or flexion and can be set
separately for extension and flexion.
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.
- Possible values for pauses: 0 – 30
seconds
8
Adjusting the force (reverse on load)
Center warm-up
- Minimum setting for reverse on load:
25 kp
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 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.
- 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 maximum resistance needed to automatically reverse the direction of motion.
Full speed & motion
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.
CAUTION!
The reverse circuit is purely a
safety measure for cramps,
spasms, locked joints, etc.
The manufacturer accepts no
liability if used improperly.
WARNING: Do not run the device in
full speed & motion when patient is in
the device!
Speed
Minimum setting for speed: 1%
Run time
Maximum setting for speed: 100%
This is the individual run time for each
treatment. To reset press SET key in the
programming mode.
5.1.3. Programming the
special functions
Device run time
Special functions are:
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.
- Center warm-up
- Full speed & motion (double speed
setting)
- Runtime (patient runtime)
- Device runtime
Save data
Programming the special functions:
1. Switch to programming mode
(section 5.1.1)
To save the programmed special functions, press the STOP key.
Press the START key: the device
checks programmed values.
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
9
6. Maintenance
7. Specifications
Electrical rating
- 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.
CAUTION!
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/42,5 cm
(approximate length) – 22 inches/56 cm
Never allow liquids to get inside
the housing or hand-held
programming unit.
Length adjustment
for upper leg
2.75 inches/7 cm
(approximate length)
- 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.
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)
- Protect the device from intensive
ultraviolet radiation (sunlight)
Surrounding Conditions
Surrounding
temperature
-11O F to +140OF
Relative humidity 20% to 85%
Air pressure
700hPa to 1060 hPa
Technical data subject to change
Operational Conditions
Surrounding
temperature
+50O F to +104OF
Relative humidity 30% to 75%
Air pressure
700hPa to 1060 hPa
10
MPG:
Class 2a
Power supply
NTEV20
Safety Transformer
In: 115/230V ~
50/60 HZ 27VA
Out: 15V ~ 1.33A
Manufacturer:
Ulmer
8. Service
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.
If you have any questions regarding
product or service, please do not
hesitate to contact us:
ORMED international
Please contact your local dealer or
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.
Headquarters Germany
ORMED GmbH & Co. KG
Merzhauser Straße 112
D-79100 Freiburg, Germany
Tel. +49 761 4566-281
Fax +49 761 4566-55281
e-mail: [email protected]
Maintenance:
Not necessary
USA, St. Paul
Tel. 1 800 440-2784
Fax 1 651 415-7414
e-mail: [email protected]
Guarantee:
2 years warranty on mechanical and
electronical parts
Czech Republic, Prague
Tel. 420 2 84094650
Fax 420 2 84094660
e-mail: [email protected]
Manufacturer:
ORMED GmbH & Co. KG
Merzhauser Straße 112
D-79100 Freiburg, Germany
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. +49
+49
Fax +49
+49
180
180
180
180
51
51
53
53
ormed.de
676 333
ormed.de
676 333
11
OF CONFORMITY
DECLARATION
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
Name
Knee & Hip
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.
0297
Freiburg, January 20, 2002
Quality Control Manager
12
Figures
Fig. 2
Fig. 6
Fig. 3
Fig. 7
Fig. 4
Fig. 8
Fig. 5
17
© ORMED 6/04
O R M E D G m b H & C o . K G • M e r z h a u s e r S t r a ß e 112 • D - 7 910 0 F r e i b u r g
Phone +49 7 61 4566-01 • Fax +49 761 4566-5501 • www.ormed.de • E-Mail: [email protected] ormed.de
St. Paul/USA, Phone +1 800 4402784, Fax +1 651 4157405 • Prague/CR, Phone +420 2 84094650,
Fax +420 2 84094660 • Vienna/A, Tel +43 1 53 20 83 40, Fax +43 1 53 20 83 431
DIN EN 13485
ORMED Nr. 018 829-01
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