Ormed ARTROMOT-K4 User manual

Operation Manual
Starting with serial number higher than 10 000
ARTROMOT®-K4
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Schnittmarke
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Device description
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21 20 19 18 17 16 15 14 13 12 11
Schnittmarke
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Device description 3
Symbol overview ARTROMOT®-K4 29
Illustrations for device setup 34
1. How to use the CPM device 5
1.1 Fields of application 5
1.2 Therapy objectives 5
1.3 Indications 5
1.4 Contraindications 5
2. Description of the ARTROMOT®-K4 6
2.1 Description of the device components 6
2.2 Description of the programming unit 7
2.3 Explanation of symbols 9
2.4 Explanation of symbols (connections and nameplate) 10
3. Safety information 11
4. Device setup 14
4.1 Connecting the device, performance check 14
4.2 Mechanical Settings 14
4.3 Adjusting the Patient Kit 15
5. Setting the treatment values 16
5.1 General information on programming ARTROMOT®-K4 16
5.2 Programming ARTROMOT®-K4 17
5.3 Therapy parameter details 17
6. Care, Maintenance 20
6.1 Care 20
6.2 Maintenance (fuse replacement) 20
6.3 Conversion 21
7. Environmental Protection Statement 22
8. Specifications 22
9. IEC 60601-1-2:2001 23
9.1 Electromagnetic emissions 23
9.2 Electromagnetic immunity 24
9.3 Recommended separation distances 26
10. Contact 26
11. Technical service 27
11.1 Technical Hotline 27
11.2 Shipment 27
11.3 Spare Parts 27
Declaration of Conformitiy 28
Contents
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ARTROMOT®-K4 is a motor-operated
Continuous Passive Motion (CPM)
device providing motion to the shoulder
joint.
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 to prevent the negative
effects of immobilization, to allow
patients to regain painless mobility of
joints at an early stage and to promote
healing and achieve a positive functio-
nal result.
Other objectives of therapy include
- improvement of joint metabolism
- prevention of joint stiffness
- promotion of the regeneration and
healing of cartilage areas and dam-
aged ligaments
- faster hematoma/fluid resorption
- improved lymph and blood circulation
- thrombosis and embolism prophylaxis
The CPM device is indicated in the
treatment of most injuries and diseases
of the knee and hip joints as well as in
the postoperative treatment after knee
and hip joint surgery. Examples
- joint distortion and contusion
- arthrotomy and arthroscopy proce-
dures in combination with synovec-
tomy, arthrolysis or other intra-articu-
lar interventions
- mobilization of joints in anesthetized
patients
- operative treatment of fractures,
pseudoarthrosis and corrective
osteotomy
- cruciate ligament replacement or
reconstruction
- endoprosthetic implants
Do NOT use ARTROMOT®-K4 on
patients with
- acute inflammatory processes in the
joints, unless on the order of a physi-
cian
- spastic paralysis
- unstable osteosynthesis
1.4 Contraindications
1.3 Indications
1.2 Therapy objectives
1.1 Fields of application
5
1. How to use the CPM device
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The motorized CPM device permits
extension and flexion of the knee joint
in the range of -10 ° - 0 ° - 125 °,
and of the hip joint in the range of
0 ° - 10 ° - 100 °.
It can be used on either side, but
requires a configuration change.
These are some of the
ARTROMOT®-K4 features
- programming unit for precise adjust-
ment of patient-specific therapy
values
- symbols for easy operation of the
programming unit
- physiological movements
- anatomically correct setup
Biocompatibility
Those parts of the ARTROMOT®-K4
device that come into contact with the
patient when the device is used as
intended, are designed to fulfil the
biocompatibility requirements of the
applicable standards.
Note:
Please fold out page 3!
1. Compartment for storage of
programming unit
2. Footplate with patient kit
3. Knobs for ankle adjustment of
foot inclination
4. Knobs for length adjustment of
lower leg
5. Lower leg patient kit
6. Knee pivot point
7. Thigh patient kit
8. Thigh support
9. Knob for femur length adjustment
10. Hip axis pivot point
11. Locking pin for high adjustment of
hip pivot point
12. Spare tube
13. Release tubes for square tube
14. Coiled cord
15. Hand-held programming unit
16. Power switch (ON/OFF)
17. Fuse cap
18. Connection for power cord
19. Connection for programming unit
20. Base
21. Knob for rotation of footplate
2.1 Description of the
device components
6
2. Description of the ARTROMOT®-K4
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2.2 Description of the programming unit
2.2.1 Programming unit in normal mode
current
carriage angle
therapy timer
set flexion value
parameter keys
MENU key
START key
STOP key
selected therapy
protocol
set extension
value
current direction
of motion
+ (plus) key
- (minus) key
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2.2.2 Programming unit in MENU selection mode
2.2.3 Programming unit in programming mode
selected MENU level set carriage angle for
internal / external
rotation
parameters available
for selection, corres-
ponding selection
keys
set extension value set flexion value
selected function
selected parameter
(here flexion)
status of the selected
function (here flexion
angle)
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Also refer to symbol overview on page 29.
extension (stretching
the knee)
flexion (bending the
knee)
speed
warm-up protocol
extension pause
flexion pause
therapy timer
reverse on load feature
for patient safety
transport setting
new patient
total therapy time
service menu
2.3 Explanation of symbols
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2.4 Explanation of symbols (connections and nameplate)
Alternating current
Protective earth
connection
Type B applied part
Power switch OFF
Power switch ON
Refer to accompanying
documents
Do not dispose of product
with unsorted household
or municipal waste.
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