Ormed ARTROMOT-K4 User manual

Operation Manual
Starting with serial number higher than 10 000
ARTROMOT®-K4
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Fold out this page
Schnittmarke
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Device description
1 23 4 5 6 789 10
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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Definitions
Read the safety statements before use
of the CPM device. The safety state-
ments are classified as follows
Safety information
Warning!
Patient hazard —
– Only authorized individuals are
allowed to operate the
ARTROMOT®-K4 device. Individuals
are authorized after receiving
training in the operation of the
device and reading this operation
manual.
− Before using the device, the opera-
tor must ascertain that it is in
correct working order and operating
condition. In particular, the cables
and connectors must be checked
for signs of damage. Damaged
parts must be replaced immediately,
before use.
−Before therapy,atest run consis-
ting of several exercise cycles must
be completed, first without and then
with the patient. Check that all
setting screws are tightened.
− Stop therapy immediately, when
you have doubts about the device
settings and/or the therapy
protocol.
− It is important that the patient's
position is anatomically correct.
Check the following settings/posi-
tions
1. femur length
2. knee joint axis
3. lower leg length and rotational
position of the leg
4. patient kits
− Movements must not cause any
pain or irritation.
− Patients must be fully conscious
while being instructed in the use of
the CPM device and during therapy.
Danger!
Explosion hazard —
ARTROMOT®-K4 is not designed for
use in areas where an explosion
hazard may occur. An explosion
hazard may result from the use of
flammable anesthetics, skin cleansing
agents and disinfectants.
Caution!
indicates a potential hazard. If not
avoided, this hazard can result in
minor personal injury and/or pro-
duct/property damage.
Warning!
This term indicates a hazard. If not
avoided, this hazard can result in
death or serious injury.
Danger!
This term indicates an imminent
hazard. If not avoided, this hazard will
result in death or serious injury.
3. Safety information
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− The choice of the therapy parame-
ters to program and of the therapy
protocols to use is restricted to
the responsible physician or
therapist. It is the physician's or
therapist's decision whether or not
to use the CPM device on a specific
patient.
− The patient must be familiar with the
functions of the ARTROMOT®-K4
programming unit and the unit must
be within easy reach of the patient,
allowing him or her to stop therapy,
if needed. Patients unable to
operate the programming unit,
e.g. paralytic patients, must never
be left unattended during therapy.
− All accessories used with the
ARTROMOT®-K4 device must first
be approved by ORMED.
− Do not allow parts of the body or
any objects (such as blankets,
cushions or cables) to get caught in
the moving parts of the CPM
device.
Warning!
Shock hazard —
Strictly observe the following war-
nings. Failure to do so endangers the
lives of the patient, the user and other
persons involved.
−Before use allow the
ARTROMOT®-K4 to reach room
temperature. If the device has been
transported at temperatures below
0 °C (32°F), leave it to dry at room
temperature for about 2 hours, until
any condensation has disappeared.
− The ARTROMOT®-K4 device must
only be operated in dry rooms.
− When disconnecting the device
from the power line, remove the
plug from the wall outlet first, before
disconnecting the cable from the
device.
− When connecting the device to
other equipment or when creating a
medical system, check that the sum
of leakage currents will not cause
any hazard. Please contact ORMED,
if you have questions in this matter.
− Do not use multiple portable socket
outlets (MPSO) to connect the
device to the power line.
ARTROMOT®-K4 must be connec-
ted to a properly installed wall
outlet with a non-fused earthed
wire. Before connecting the power
cord, it must be completely unrolled
and placed such that it will not get
caught in the moving parts of the
device.
− Before cleaning and service inter-
ventions, disconnect the device
from the power line by removing
the power cord from the wall outlet.
− Liquids must not be allowed to
enter the CPM device or the pro-
gramming unit. If liquids have
entered into the devices,
ARTROMOT®-K4 must be immedia-
tely checked by a service techni-
cian, before it can be reused.
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Caution!
Preventing chafing and pressure sores
If your patient is adipose, very tall
or very short, be sure to prevent
chafing and pressure sores. Place the
leg concerned in a moderate abduc-
tive position, if deemed appropriate.
Warning!
Equipment malfunction 
– Magnetic and electrical fields are
capable of interfering with the
proper performance of the device.
For this reason make sure that all
external devices operated in the
vicinity of the CPM device comply
with the relevant EMC requirements.
X-ray equipment, MRI devices, radio
systems and cell phones are possi-
ble sources of interference as they
may emit higher levels of electroma-
gnetic radiation.
Keep the CPM device away from
these devices and verify its perfor-
mance before use.
− Refer repair and maintenance to
authorized persons.
−Route all cables below the device
frame to either side, ensuring that
they cannot get caught in the
moving parts during operation.
− Inspect ARTROMOT®-K4 for
damage and loose connections at
least once a year. Damaged and
worn parts must immediately be
replaced with original spare parts by
authorized staff.
Caution!
Equipment damage 
– Check that the voltage and fre-
quency ratings of your local power
line are those indicated on the
nameplate.
− The leg support element withstands
amaximum continuous load of
30 kg (66.13 lb).
− Do not allow any objects (such as
blankets, cushions, or cables) to get
caught in the moving parts of the
CPM device.
− Do not expose the ARTROMOT®-K4
device to direct sunlight, because
some of the components may reach
inadmissibly high temperatures.
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Note: For a better understanding of
each step, please fold out pages 3
and 34.
1. Connect the power cord to socket
(18) of the device and connect the
mains plug to a wall outlet with a
non-fused earthed wire
(100 to 240 Volt, 50/60 Hz).
2. Connect the programming unit (15) to
socket (19) of the device.
3. Turn the power switch (16) on.
4. Follow these steps to set the carriage
to the home position
• Press the MENU button on the
programming unit until you reach
programming level 4.
• Press the New Patient parameter
key twice.
• Press the START key. The CPM
device automatically enters the
home position.
If the programming unit can be opera-
ted as described above and
ARTROMOT®-K4 enters the home
position (for home position values, refer
to section 5.3), the device has passed
the performance check.
The device also runs performance
checks regularly during operation. This
is what happens, if a problem is identi-
fied
− An audio signal sounds.
− The device switches off immediately.
− The message "ERR" and an error
code (e.g. ERR 5) appear on the
display.
In this situation, you may attempt to
restart the device by turning it briefly off
and on again with the power switch. If
the error message persists, have the
device inspected by a Service techni-
cian, before using it again.
1. Set the carriage to the home position
(see 4.1) or to an angle that allows
the patient to position the leg on the
support without experiencing any
pain.
2. To begin with, set the hip pivot (10) of
the carriage to the patient's hip pivot.
• To do so, pull on the locking pin
(11) of the height adjustment for the
carriage hip pivot (10).
• Then lift the insert for adjusting the
height of the carriage hip pivot to
the level of the patient's greater
trochanter.
• Now re-insert the locking pint (11).
Note!
Before you adjust the ARTROMOT®-K4
to the patient, you may have to
convert the device for use on the left
or right knee joint.
(see section 6.3 Conversion)
Caution!
Equipment damage
Connect only the original program-
ming unit designed for the device in
use. Any attempt to connect another
programming unit to this device may
cause damage.
4.2 Mechanical Settings
Performance check
4.1 Connecting the device,
performance check
4. Device setup
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3. Adapting the carriage to the femur
length (Fig. 2)
• Press on the locking pin at the
femur length adjustment (9) to
release the lock.
• Adjust the appropriate femur length
(8).
• Fix the setting by releasing the
locking pin (9).
4. Adapting the carriage to the tibia
length (Fig. 3)
• Loosen the two fixation screws (4).
• Adjust the appropriate tibia length.
The setting should exactly match
the length of the patient's lower leg.
• Tighten the screws (4) to fix the
setting.
5. Adjusting the dorsal extension /
plantar flexion position (Fig. 4)
• Loosen the two fixation screws (3).
• Set the foot plate (2) to an angle
that is comfortable for the patient.
• Tighten the screws (3) to fix the
angle setting.
6. Adjusting the foot rotation position
(Fig. 5)
• Loosen the fixation screw (21).
• Set the foot plate (2) to a rotation
position that is comfortable for the
patient.
• Tighten the screw (21) to fix the
setting.
1. Using the Velcro tapes, attach the
patient kits for lower leg (5) and thigh
(7) to the frame of the motion ele-
ment. (Fig. 6 and Fig. 7)
2. Now position the patient's leg on the
carriage and adjust the height with
the help of the Velcro tapes and by
repeating the steps at 1.
Ensure that the exercise will only be
performed in a range of motion that
does not cause any pain and provides
maximum comfort for the patient,
Caution!
Patient hazard
Ensure that the rotational axes of the
CPM device and of the knee joint
coincide both in the vertical and in the
horizontal plane (Fig.8).
4.3 Adjusting the Patient Kit
Caution!
Equipment damage
Please do not try to pull out the femur
length adjustment past the stop.
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Note: See also 2.2 and 2.3 as well as
page 29!
1. You activate the programming mode
by briefly pressing the MENU key on
the programming unit.
2. The treatment parameters and
functions are allocated to four pro-
gramming levels (four per level).
To be able to program a parameter
you will have to access the corres-
ponding programming level. This is
also done with the MENU key. With
each key press you advance one
level. The code M1, M2, etc. that
appears in the middle of the display
indicates the programming level.
If you wish to return to the previous
programming level (e.g. from level 3
to 2), press the MENU key and hold
it pressed for a short time.
3. You activate the treatment parame-
ters and functions with the four
parameter keys below the display.
The symbols above the four para-
meter keys indicate the assigned
parameters and functions.
This is what happens when you press
one of the parameter keys to select a
parameter
• The corresponding symbol appears
on the display in a larger format.
• The set value is displayed.
• The symbol above the parameter
key appears in reverse video.
4. With the +/-keys (plus/minus) you
change the displayed value. When
you press and hold the key, the value
will change at a higher rate.
Some of the (special) functions can
only be enabled and disabled. This is
done by pressing the corresponding
parameter key or with the + / - keys.
Active parameters are identified with
a check mark in the circle next to the
symbol.
5. Then press the START key to start
therapy.
If a special function is activated, the
carriage will first move to the middle
position. Press the START key again
to start therapy.
Note!
• Refer to section 5.3 for a descrip-
tion of the parameters.
• To view the set parameter values,
press the corresponding parameter
key. However, this is only possible
when you press the STOP key first.
• To prevent accidental changes of
the parameter settings, lock the
keys by simultaneously pressing
the + (plus) and – (minus) keys.
by simultaneously pressing the +
(plus) and – (minus) keys. Press both
keys again to unlock.
• Emergency stop function
ARTROMOT®-K4 will stop immedia-
tely, when any of the keys is pressed
during therapy. Patient treatment can
be resumed by pressing the START
key. The device will automatically
change the direction.
5.1 General information
on programming
ARTROMOT®-K4
Warning!
Patient hazard 
Before therapy, a test run consisting
of several exercise cycles must be
completed without the patient. Then
repeat the test run with the patient
and check that the movement does
not cause any pain.
5. Setting the treatment values
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To program the different settings of the
ARTROMOT®-K4, access the respec-
tive programming level.
You change between levels by pressing
the MENU key repeatedly.
The display always indicates the
currently selected level.
The following treatment values,
settings and information can be
entered/viewed on the programming
unit (15)
LEVEL 1:
- Extension
(stretching the knee)
- Speed
- Warm-up protocol
- Flexion
(bending the knee)
LEVEL 2:
- Extension pause
- Therapy timer
- Reverse on load
(feature for patient safety)
- Flexion pause
LEVEL 3:
- Transport setting
- New patient
- Total therapy time
- Service menu
• You access the different program-
ming levels by repeated depressions
of the MENU key.
• You select the treatment parameters
with the corresponding parameter
key.
• You change the treatment values with
the +/-keys and you enable/disable
functions by pressing the correspon-
ding parameter key again.
• You save the settings by pressing the
STOP key.
5.2 Programming
ARTROMOT®-K4
• If the carriage is positioned within
the programmed range of motion at
the time therapy begins, the therapy
session will start immediately.
• If the carriage is positioned outside
the programmed range of motion at
the time therapy begins, it will first
move to the angle setting "extension
+10°". It will stop in this position
and you can start the therapy
session by pressing the START key.
5.3 Therapy parameter
details
Note!
It is possibe to modify individual
treatment parameters or all parame-
ters together. If individual treatment
parameters are modified, the settings
of all other parameters remain
unchanged.
MENU
MENU
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LEVEL 1:
■Extension (stretching)
- Maximum knee extension
-10 degrees
- Maximum hip extension:
10 degrees
■Flexion (bending)
- Maximum knee flexion:
125 degrees
- Maximum hip flexion:
100 degrees
■Speed
The speed can be adjusted between
1 % (0.3°/s) and 100 % (3°/s) in steps
of 1 %.
Default: 100 %
■Warm-up protocol
During warm up, the patient will
slowly become used to the set
maximum extension and flexion
values, starting from the center
position.
The warm up protocol starts in the
middle between the two maximum
values set for stretching and bending.
With each cycle, the range of motion
is increased, within 15 cycles the
maximum value is attained.
Default: disabled
LEVEL 2:
■Extension pause
Pauses occur at the extension limit,
just before the bending movement
starts. Pauses are adjustable in
steps of 1 second between 0 and
30 seconds
Default: no pause
■Flexion pause
Pauses occur at the flexion limit,
just before the stretching movement
starts. Pauses are adjustable in
steps of 1 second between 0 and
30 seconds
Default: no pause
■Therapy timer
Default setting is continuous
operation.
A clock symbol in the upper right-
hand corner of the display identifies
the continuous mode of operation.
The clock indicates the elapsed
therapy time.
In the continuous mode, the device
must be stopped with the STOP key.
However, the therapy timer can be
set in steps of 1 minute to any
value between 1 and 300 minutes.
When the time has elapsed, the
device switches automatically off and
stops in the position – set extension-
value +10°.
In this case, a circle replaces the
clock symbol. The circle fills as the
therapy time progresses.
■Reverse on load feature
for patient safety
The device automatically starts
moving in the opposite direction of
the last movement when the patient's
resistance (load) exceeds the set
value.
Adjustable levels for reverse on load
feature 1-25
minimum setting 1 10 kp
maximum setting 25 45 kp.
At 1/10 kp, very little resistance will
cause the device to reverse; at
25/45 kp, a high resistance is requi-
red to initiate the reversal.
Default: 25/45 kp
Note!
• These values are approximate
values.
• The force needed is measured at
the frame around the foot.
Note!
The programmed value and the value
measured at the patient's knee may
deviate slightly. The most important
factor is painless motion of the
patient's knee.
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LEVEL 3:
■Transport setting
With this function, the carriage will
move to a position optimally suited
for packing the CPM device. Select
the function and press the START
key. The carriage moves to the
transport position.
■New patient
With this function, the CPM device
will move to the home position,
allowing the mechanical settings to
be completed. Select the function
and press the START key. The device
enters the home position and existing
therapy parameters will be deleted.
The "new patient" function (home
position) selects the following
settings
- extension 25 °
- flexion 35 °
- speed 100 %
- warm up disabled
- extension pause 0
- flexion pause 0
- timer continuous
operation
- reverse on load 25/45 kp
- total therapy time 0
■Total therapy time
The total therapy time is the added
sum of operating hours.
If the device is used by only one
patient, this time is equivalent to the
duration of all the patient's therapy
sessions.
Deleting the stored therapy time
Press and hold the parameter key for
5 seconds or select the New Patient
function.
■Service menu
For service purposes only, refer to
Service Manual.
Reminder:
You save the selected parameter values
by pressing the STOP key.
Caution!
Patient hazard The reverse on load
feature is a safety measure to protect
the patient in the event of cramps,
spasms, locked joints and similar
situations. The manufacturer cannot
be held liable for misuse of this
feature.
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- ARTROMOT®-K4 can be disinfected
by wiping down with a disinfectant.
Thus, it complies with the special
hygiene standards for medical
technical equipment.
-The enclosure can be cleaned with
common disinfectants and mild
household cleaning agents.
- Only use a damp cloth to wipe the
CPM device down.
Visually inspect the device for signs of
mechanical damage before each use.
If you detect damage or malfunctions
that may impair the safety of the patient
or of the operator, have the device
repaired before using it.
For safety, the devices require regular
maintenance. To maintain the functional
and operational safety, check all com-
ponents for damage and loose connec-
tions at least once a year.
These checks should be performed by
persons with adequate training and
experience. Damaged and worn parts
must immediately be replaced with
original spare parts by authorized staff.
The device does not require additional
regular maintenance.
Warning!
Patient hazard, equipment malfunc-
tion and damage 
The replacement of fuses must be
referred to specialists as defined in
IEC 60364 or other applicable stan-
dards (e.g. biomedical technicians,
electricians, electronics installers).
Before replacing fuses, turn off the
ARTROMOT®-K4 and disconnect the
device from the power line.
Fuses used must be T1A fuses.
Fuse replacement
Technical inspections
Check before each use
6.2 Maintenance
(fuse replacement)
Caution!
Equipment damage 
− The plastic material used is not
resistant to mineral acids, formic
acid, phenols, cresols, oxidants and
strong organic or inorganic acids
with a pH value below 4.
− Use only clear disinfectants to
prevent discoloration of the device.
− Do not expose the CPM device to
strong ultraviolet radiation (sunlight)
and fire.
− Do not use cleaning agents that
contain chloride.
Warning!
Shock hazard 
Remove the power cord from the wall
outlet before cleaning.
Shock hazard, equipment damage 
Liquids must not enter the device or
the programming unit.
6.1 Care
20
6. Care, Maintenance
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