ARTROMOT®-K3 - The Medcom Group, Ltd.

ARTROMOT®-K3 - The Medcom Group, Ltd.
ARTROMOT®-K3
USA/GB
Operation Manual
Starting with serial number higher than 10000
Fold out this page
Device description
1
2
17
3
4
16
5
15 14 13
12
6
7
11
8
10
9
Device description
3
Symbol overview
29
Illustrations for device setup
32
1. How to use the CPM device
1.1 Fields of application
1.2 Therapy objectives
1.3 Indications
1.4 Contraindications
5
5
5
5
5
2. Description of the ARTROMOT®-K3
2.1 D
escription of the device components
2.2 Description of the programming unit
2.4 Explanation of symbols (connections and nameplate)
6
6
7
10
3. Safety statements
11
4. Device setup
4.1 C
onnecting the device, performance check
4.2 Mechanical Settings
4.3 Adjusting the Patient Kit
14
14
14
15
5. Setting the treatment values
5.1 G
eneral information on programming ARTROMOT®-K3
5.2 P
rogramming ARTROMOT®-K3
5.3 T
herapy parameter details
16
16
17
17
6. Care, Maintenance
6.1 Care
6.2 M
aintenance (fuse replacement)
20
20
20
7. Environmental Protection Statement
22
8. Specifications
22
9. IEC 60601-1-2:2001
9.2 Electromagnetic immunity
9.2 Electromagnetic immunity
9.3 Recommended Separation Distances
23
24
25
26
10. Contact
26
11. Technical service
11.1 Technical Hotline
11.2 Shipment
11.3 Spare Parts
27
27
27
27
12. Declaration of conformity
28
1. How to use the CPM device
1.1 Fields of application
1.3 Indications
ARTROMOT®-K3 is a motor-operated
motion device used for Continuous
Passive Motion (CPM) for the knee and
hip joints.
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:
Suitable for use in hospitals, clinics,
general practices and rental services, it
is an important supplement to medical
and therapeutic treatment.
- joint distortion and contusion
- arthrotomy and arthroscopy procedures in combination with synovectomy, arthrolysis or other intra-articular
interventions
1.2 Therapy objectives
- mobilization of joints in anesthetized
patients
CPM therapy with ARTROMOT®-K3 is
mainly used to prevent the negative effects of immobilization, to allow patients
to regain painless movement of joints at
an early stage and to promote healing
and achieve a positive functional result.
- operative treatment of fractures,
pseudarthrosis and corrective osteotomy
- cruciate ligament replacement or
reconstruction
- endoprosthetic implants
Other objectives of therapy include:
- improvement of joint metabolism
- prevention of joint stiffness
1.4 Contraindications
- promotion of the regeneration and
healing of cartilage areas and damaged ligaments
Do NOT use ARTROMOT®-K3 on
patients with:
- faster hematoma/fluid resorption
- improved lymph and blood circulation
- acute inflammatory processes in the
joints, unless on the order of a physician
- thrombosis and embolism prophylaxis
- spastic paralysis
- unstable osteosynthesis
2. Description of the ARTROMOT®-K3
The motorized CPM device permits
extension and flexion of the knee joint in
the range of -5 ° - 0 ° - 110 °,
2.1 Description of the device
components
and of the hip joint in the range of
0 ° - 8 ° - 86 °.
Note: Please fold out page 2!
It can be used on either side and requires no configuration change.
1.Compartment for storage of
programming unit
These are some of the
2.Footplate with patient kit
ARTROMOT®-K3 features:
3.Knobs for ankle adjustment of foot
inclination
- programming unit for precise adjustment of patient-specific therapy
values
4.Knobs for length adjustment of
lower leg
- symbols for easy operation of the
programming unit
5.Lower leg patient kit
6.Knee pivot point
7.Knob for femur length adjustment
8.Thigh support
Biocompatibility
9.Thigh patient kit
Those parts of the ARTROMOT®-K3
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.
10.Base
11.Coiled cord
12.Hand-held programming unit
13.Power switch (ON/OFF)
14.Fuse cap
15.Connection for power cord
16.Connection for programming unit
17.Knob for rotation of footplate
2.2 Description of the programming unit
2.2.1 Programming unit in normal mode
set carriage angle
selected therapy
protocol
therapy timer
set extension
value
set flexion value
selected direction
of motion
parameter keys
MENU key
“+” key
START key
“-” key
STOP key
2.2.2 Programming unit in MENU selection mode
selected MENU
level
set carriage angle
set extension
value
set flexion value
parameters
available for
selection,
corresponding
selection keys
2.2.3 Programming unit in programming mode
selected function
set flexion value
selected parameter
(here: flexion)
2.3 Explanation of symbols
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
2.4 Explanation of symbols (connections and nameplate)
alternating current
protective earth connection
type B applied part
power switch OFF
power switch ON
m
Refer to accompanying documents
Do not dispose of product with unsorted
household or municipal waste.
10
3. Safety statements
Definitions
m Warning!
It is mandatory to read the safety statements before use of the CPM device.
The safety statements are classified as
follows:
Patient hazard—
− Only authorized individuals are allowed to operate the
ARTROMOT®-K3 device. Individuals are authorized after receiving
training in the operation of the
device and reading this operation
manual.
m Danger!
This term indicates an imminent
hazard. If not avoided, this hazard will
result in death or serious injury.
− Before using the device, the operator 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.
m Warning
This term indicates a hazard. If not
avoided, this hazard can result in
death or serious injury.
− Before therapy, a test run consisting of several exercise cycles
must be completed, first without
and then with the patient. Check
that all setting screws are tightened.
m Caution
This term indicates a potential hazard. If not avoided, this hazard can
result in minor personal injury and/or
product/property damage.
− Stop therapy immediately, when
you have doubts about the device
settings and/or the therapy protocol.
Safety information
− It is important that the patient‘s
position is anatomically correct.
Check the following settings/positions:
m Danger
Explosion hazard—
1. femur length
ARTROMOT®-K3 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.
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.
11
m Warning!
− The choice of the therapy
parameters 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.
Shock hazard —
Strictly observe the following warnings. Failure to do so endangers the
lives of the patient, the user and other
persons involved.
− Before use allow the
ARTROMOT®-K3 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 patient must be familiar with the
functions of the ARTROMOT®-K3
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.
− The ARTROMOT®-K3 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.
− All accessories used with the
ARTROMOT®-K3 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.
− 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®-K3 must be connected 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 interventions, 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 programming unit. If liquids have entered
into the devices, ARTROMOT®-K3
must be immediately checked by a
service technician, before it can be
reused.
12
m Warning!
m Caution!
Equipment malfunction —
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 abductive position, if deemed
appropriate.
− 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 possible sources of interference as they may emit higher
levels of electromagnetic radiation.
Keep the CPM device away from
these devices and verify its performance before use.
m Caution!
Equipment damage —
− Check that the voltage and frequency ratings of your local power
line are those indicated on the
nameplate.
− Refer repair and maintenance to
authorized persons.
− The leg support element withstands a maximum continuous
load of 30 kg (66.13 lb).
− Route all cables below the device frame to either side, ensuring
that they cannot get caught in the
moving parts during operation.
− Do not allow any objects (such as
blankets, cushions, or cables) to
get caught in the moving parts of
the CPM device.
− Inspect ARTROMOT®-K3 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.
− Do not expose the
ARTROMOT®-K3 device to direct
sunlight, because some of the
components may reach inadmissibly high temperatures.
13
4. Device setup
Note: For a better understanding of
each step, please fold out pages 3
and 32.
off and on again with the power switch.
If the error message persists, have the
device inspected by a Service technician, before using it again.
4.1 Connecting the device,
performance check
m Caution!
Equipment damage—
Connect only the original programming unit designed for the device in
use. Any attempt to connect another
programming unit to this device may
cause damage.
1.Connect the power cord to socket
(15) of the device and connect the
mains plug to a wall outlet with a nonfused earthed wire (100 to 240 Volt,
50/60 Hz).
2.Connect the programming unit (12)
to socket (16) of the device.
3.Turn the power switch (13) on.
4.2 Mechanical Settings
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 3.
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.
• Press the New Patient parameter
key
.
2.Adapting the carriage to the femur
length (Fig. 2)
• Press the START key. The CPM device automatically enters the home
position.
• Loosen the two fixation screws (7).
• Adjust the appropriate femur length
(8).
• Tighten the screws (7) to fix the
setting.
Performance check
If the programming unit can be
operated as described above and
ARTROMOT®-K3 enters the home
position (for home position values, refer
to section 5.3), the device has passed
the performance check.
m Caution!
Equipment damage—
Please do not try to pull out the femur
length adjustment past the stop.
The device also runs performance
checks regularly during operation.
This is what happens, if a problem is
identified:
3.Adapting the carriage to the tibia
length (Fig. 3)
− An audio signal sounds.
• Loosen the two fixation screws (4).
− The device switches off immediately.
• Adjust the appropriate tibia length.
The setting should exactly match
the length of the patient‘s lower
leg.
− The message „ERR“ and an error
code (e.g. ERR 5) appear on the
display.
• Tighten the screws (4) to fix the
setting.
In this situation, you may attempt to
restart the device by turning it briefly
14
4.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.
5.Adjusting the foot rotation position
(Fig. 5)
• Loosen the fixation screw (17).
• Set the foot plate (2) to a rotation
position that is comfortable for the
patient.
• Tighten the screw (17) to fix the
setting.
4.3 Adjusting the Patient Kit
1.Using the Velcro tapes, attach the patient kits for lower leg (5) and thigh (9)
to the frame of the motion element.
(Fig. 6 an 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,
m 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).
15
5. Setting the treatment values
m Warning!
• The symbol above the parameter
key appears in reverse video.
Patient hazard —
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.
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.
Note: See also 2.2 and 2.3 as well as
page 29!
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.
5.1 G
eneral information on
programming
ARTROMOT®-K3
Note!
1.You activate the programming mode
by briefly pressing the MENU key on
the programming unit.
• Refer to section 5.3 for a description of the parameters.
2.The treatment parameters and functions are allocated to three programming levels (four per level).
To be able to program a parameter
you will have to access the corresponding 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.
• 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.
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.
Press both keys again to unlock.
3.You activate the treatment parameters
and functions with the four parameter
keys below the display. The symbols
above the four parameter keys
indicate the assigned parameters and
functions.
This is what happens when you press
one of the parameter keys to select a
parameter:
• Emergency stop function:
ARTROMOT®-K3 will stop immediately, 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.
• The corresponding symbol appears
on the display in a larger format.
• The set value is displayed.
16
LEVEL 3:
• If the carriage is positioned within
the programmed range of motion
at the time therapy begins, the
therapy session will start immediately.
- Transport setting - New patient
- Total therapy time
- Service menu
• 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.
Note!
It is possibe to modify individual
treatment parameters or all parameters together. If individual treatment
parameters are modified, the settings
of all other parameters remain unchanged.
5.2 P
rogramming
ARTROMOT®-K3
5.3 Therapy parameter
details
To program the different settings of the
ARTROMOT®-K3, access the respective programming level.
• You access the different programming
levels by repeated depressions of the
MENU key.
You change between levels by pressing
the MENU key repeatedly.
The display always indicates the currently selected level.
• You select the treatment parameters
with the corresponding parameter
key.
The following treatment values, settings and information can be entered/
viewed on the programming unit (12):
• You change the treatment values with
the + / - keys and you enable/disable
functions by pressing the corresponding parameter key again.
LEVEL 1:
• You save the settings by pressing the
STOP key.
- Extension (stretching the knee)
- Speed LEVEL 1:
- Warm-up protocol nExtension (stretching) - Fexion (bending the knee) - Maximum knee extension:
-5 degrees
- Maximum hip extension:
8 degrees
LEVEL 2:
nFlexion (bending)
- Extension pause - Maximum knee flexion:
110 degrees
- Therapy timer
- Reverse on load feature for patient safety - Maximum hip flexion:
86 degrees
- Flexion pause Note!
The programmed value and the
value measured at the patient‘s
knee may deviate slightly.
17
In this case, a circle replaces the
clock symbol. The circle fills as the
therapy time progresses.
nSpeed The speed can be adjusted between
1 % and 100 % in steps of 1 %.
Default: 100 %
nReverse 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
nWarm-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
minimum setting 1 = 25 kp
maximum setting25 = 45 kp
At 1/25 kp very little resistance will
cause the device to reverse;
at 25/45 kp, a high resistance is
required to initiate the reversal.
Default: 45 kp
LEVEL 2:
Note!
nExtension pause
• These values are approximate
values.
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
• The force needed is measured at
the frame around the foot.
m Caution!
nFlexion pause
Patient hazard —
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
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.
nTherapy timer
LEVEL 3:
Default setting is continuous
operation.
nTransport 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.
A clock symbol in the upper righthand 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°.
18
nNew 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: 45 kp
- total therapy time: 0
nTotal 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.
nService menu
For service purposes only, refer to
Service Manual.
Reminder
You save the selected parameter values
by pressing the STOP key.
19
6. Care, Maintenance
6.1 Care
6.2 Maintenance (fuse replacement)
m Warning!
Shock hazard —
Check before each use
Remove the power cord from the wall
outlet before cleaning.
Visually inspect the device for signs of
mechanical damage before each use.
Shock hazard, equipment damage ⎯
Liquids must not enter the device or
the programming unit.
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.
• ARTROMOT®-K3 can be disinfected
by wiping down with a disinfectant.
Thus, it complies with the special hygiene standards for medical technical
equipment.
Technical inspections
For safety, the devices require regular
maintenance. To maintain the functional and operational safety, check all
components for damage and loose
connections at least once a year.
• The enclosure can be cleaned with
common disinfectants and mild
household cleaning agents.
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.
• Only use a damp cloth to wipe the
CPM device down.
m Caution!
The device does not require additional
regular maintenance.
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.
20
Fuse replacement
m Warning!
Patient hazard, equipment malfunction and damage —
The replacement of fuses must be referred to specialists as defined in IEC
60364 or other applicable standards
(e.g. biomedical technicians, electricians, electronics installers).
Before replacing fuses, turn off the
ARTROMOT®-K3 and disconnect the
device from the power line.
Fuses used must be T1A fuses.
Use an appropriate tool to remove the
fuse holder situated between the power
switch and the power connector
(Fig. 1). Replace the fuses and reinsert
the fuse holder (Fig. 2). Ensure that the
fuse holder properly locks into place.
Fig. 1
Fig. 2
21
Standards compliance:
7. Environmental Protection Statement
IEC 606011:1988
+ A1:1991
+ A2: 1995
Certification:ANSI / UL
60601-1
The product described in this operation
manual must not be disposed of with
unsorted household or municipal waste.
It requires separate disposal.
CAN / CSA
C22.2 No. 601.1
EMC
IEC 60601-1(electromagnetic 2:2001
compatibility) Please contact ORMED or your local
dealer for information about the possible recycling of the product.
Ambient conditions
(storage, transport)
Ambient temperature:-24 ºC to +60 ºC
(50 to +104 °F)
Relative humidity:20 % to 85 %
8. Specifications
Atmospheric pressure:700 hPa to
1060 hPa
Input ratings:100 – 240 V AC
/ 50 – 60 Hz
Ambient conditions
(operation)
Current consumption: 850 - 370 mA
Ambient temperature:+10 ºC to +40 ºC
(50 to +104 °F)
Fuses:2 x T1A
(slow-blow)
Protection class:
Relative humidity:30% to 75%
I
Atmospheric pressure:700 hPa to
1060 hPa
IP degree of protection:IPX0
Applied part:
____________________________________
type B
Subject to change without notice (10/07)
Max. load on carriage:30 kg (66.13 lb)
Physical:
Length:93 cm
(36.61 In)
Width:35 cm
(13,78 In)
Height:43 cm (16.93 in)
Adjustment ranges (min./max.):
femur range:approx.
36 – 46 cm
(14.17 – 18.11 In)
lower leg range:approx.
42.5 – 56 cm
(16.73 – 22.04 In)
Weight:
11.8 kg (26.01 lb)
Materials used:
ABS, POM (Delrin 100), PUR, PA, FR4,
aluminum, stainless steel, brass
Steel: 1.4301; 1.4305; 1.4310
MDD: class 2a
22
9. IEC 60601-1-2:2001
The ARTROMOT®-K3 device is subject
to particular precautions regarding
electromagnetic compatibility (EMC).
The device must be installed and put
into service strictly in compliance with
the EMC directives put forth in the
accompanying documents.
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.
If it is necessary to replace assemblies
or cables
only the manufacturer‘s original parts
may be used to ensure
Portable and mobile RF communication
systems may affect the
ARTROMOT®-K3 device.
continued compliance with EMC requirements after repair. This requirement
applies to the power supply unit, cables
and cable lengths, drive unit consisting
of the motor and the control system, the
programming unit incl. the coiled cable
and the connector.
The ARTROMOT -K3 device should
not be used adjacent to or stacked with
other equipment. If adjacent or stacked
use is necessary, ARTROMOT®-K3
should be observed to verify normal
operation in the configuration in which it
will be used.
®
Electromagnetic emissions
9.1 Electromagnetic emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
ARTROMOT®-K3 is intended for use in the electromagnetic environment specified below. It is
the responsibility of the customer or user to ensure that the ARTROMOT®-K3 device is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions to CISPR 11
Group 1
ARTROMOT®-K3 uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions to CISPR 11
Class B
ARTROMOT®-K3 is suitable for use in all
establishments, including domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions to IEC
61000-3-2
not applicable
Voltage fluctuations/flicker
emissions to IEC 61000-3-3
not applicable
23
9.2 Electromagnetic immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
ARTROMOT®-K3 is intended for use in the electromagnetic environment specified below. It is
the responsibility of the customer or user to ensure that the ARTROMOT®-K3 device is used in
such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment guidance
Electrostatic
discharge
(ESD) to IEC
61000-4-2
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
to IEC 610004-5
± 2 kV for power
supply lines
± 2 kV for power
supply lines
Mains power should be that of a typical
commercial or hospital environment.
± 1 kV for
input/output lines
± 1 kV for
input/output lines
Surges to IEC
61000-4-5
± 1 kV differential
mode
± 1 kV differential
mode
± 2 kV common
mode
± 2 kV common
mode
< 5 % UT
< 5 % UT
(> 95 % dip in UT)
for ½ cycle
Voltage dips,
short interruptions and
voltage variations on power
supply input
lines to IEC
61000-4-11
(> 95 % dip in UT)
for ½ cycle
40 % UT
(60 % dip in UT)
for 5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
(30 % dip in UT) for for 25 cycles
25 cycles
< 5 % UT
(> 95 % dip in UT)
for 5 s
< 5 % UT
70 % UT
Mains power should be that of a typical
commercial or hospital environment.
Mains power should be that of a typical
commercial or hospital environment. If
the user of the ARTROMOT®-K device
requires continued operation during
power mains interruptions, it is recommended that the ARTROMOT®-K3
device be powered from an uninterruptible power supply or a battery.
(> 95 % dip in UT)
for 5 seconds
Power frequency (50/60
Hz) magnetic
field to IEC
61000-4-8
3 A/m
Power frequency magnetic fields
should be at levels characteristics of a
typical location in a typical commercial
or hospital environment.
3 A/m
NOTE: UT is the a.c. mains voltage prior to application of the test level.
24
9.2 Electromagnetic immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
ARTROMOT®-K3 is intended for use in the electromagnetic environment specified below. It is
the responsibility of the customer or user to ensure that the ARTROMOT®-K3 device is used in
such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment
- guidance
Portable and mobile RF communications equipment are used no closer
to any part of the ARTROMOT®-K3
device, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
Conducted RF
to IEC 610004-6
3 Vrms
3 Vrms
d =
3 V/m
d = 80MHz to 800 MHz
150 kHz to
80MHz
Radiated RF to 3 V/m
IEC 61000-4-3
80 MHz to 2.5
GHz
d = 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a , is less than the
compliance level in each frequency
range b.. Interference may occur
in the vicinity of equipment
marked with the following
symbol
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the ARTROMOT®-K3 device is used exceeds the applicable
RF compliance level above, the ARTROMOT®-K3 device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the ARTROMOT®-K3 device.
b)Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
25
9.3 Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications
equipment and the ARTROMOT®-K3 device
The ARTROMOT®-K3 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the ARTROMOT®-K3 device
can help prevent electromagnetic interferences by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the ARTROMOT®-K3
device as recommended below, according to the maximum output power of the communications
equipment.
rated maximum output
power of transmitter
W
separation distance according to frequency of transmitter
m
800 MHz to 2.5 GHz
150 kHz to 80 MHz
80 MHz to 800 MHz
d = 1.2 öäP
d = 1.2 öäP
d = 1.2 öäP
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: For calculation of the recommended separation distance of transmitters in the
frequency range from 80 MHz to 2.5 GHz an additional factor of 10/3 was taken into account to
reduce the probability of mobile/portable communications equipment brought into the patient
environment by accident causing any malfunction.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
10. Contact
We would be happy to answer any
questions you may have about our
products and services.
Warranty:
2 years (mechanical parts)
2 years (electronics)
nOrmed international
Please contact your local dealer
or the ORMED headquarters in
Germany.
Sales:
Ormed GmbH & Co. KG
Merzhauser Strasse 112
D-79100 Freiburg - Germany
nHeadquarters Germany
Ormed GmbH & Co. KG
Merzhauser Strasse 112
D-79100 Freiburg - Germany
Tel. +49/761/45 66-01
Fax +49/761/45 66 55-01
nWebsite
www.ormed.de
e-mail: [email protected]
26
11. Technical service
11.1 Technical Hotline
Do you have any technical questions?
Do you need technical service?
Telephone:
Fax:
+49-180-5-1 ormed de
+49-180-5-1 67 63 33
+49-180-5-3 ormed de
+49-180-5-3 67 63 33
11.2 Shipment
To prevent damage during transport,
only use the original shipping box. These boxes can be obtained from ORMED
or from your local dealer.
Before packing the CPM device, set it to
the transport position (see chapter 5).
11.3 Spare Parts
Refer to the Service Manual for the most
recent list of spare parts. The Service
Manual can be obtained from ORMED
or from your local dealer.
When ordering spare parts, always
specify:
- item
- Description
- Part number
- Qty
- Serial number of the CPM device
Note!
Refer repairs to authorized, specially
trained staff.
27
Declaration of conformity
In compliance with the Council Directive 93/42/EEC of 14 June 1993
concerning medical devices, the company
ORMED GmbH & Co.KG
Merzhauser Strasse 112
D-79100 Freiburg - Germany
declares that the products of the product line
ARTROMOT® (see Annex)
fulfill the requirements of the Council Directive 93/42/EEC of 14 June 1993,
Annex II as well as the essential requirements of Annex I.
With reference to Rule 9 of the Directive 93/42/EEC, these products are
devices of risk class IIa.
0297
Freiburg, 22.10.07
_____________________________________
- QA Management Representative -
This certificate is valid through: 22. October 2010
Annex:
ARTROMOT®-S2PRO
ARTROMOT®-S3
ARTROMOT®-S3 Comfort
ARTROMOT®-K1
ARTROMOT®-K2
ARTROMOT®-K2PRO
ARTROMOT®-K2PRO Chip
ARTROMOT®-K3
ARTROMOT®-K4
ARTROMOT®-SP2
ARTROMOT®-SP3
ARTROMOT®-E2
ARTROMOT®-E2compact
28
Symbol overview
LEVEL 1:
Extension
(stretching)
speed
warm-up protocol
Flexion (bending)
Therapy Time
reverse on load
feature for patient
safety
pause Flexion
new patient
total therapy time
Service Menu
LEVEL 2:
pause Extension
LEVEL 3:
transport setting
29
Notes
30
Notes
31
Illustrations for device setup
Fig. 2
Fig. 6
Fig. 3
Fig. 7
Fig. 4
Fig. 8
Fig. 5
32
Fold out this page
33
MOT-322-01/01-12/07
ORMED GmbH & Co. KG • Merzhauser Straße 112 • D-79100 Freiburg
Tel +49 761 4566-01 • Fax +49 761 4566-5501 • www.ormed.de
E-Mail: [email protected]
DIN EN 13485
ORMED Nr. 018 829-01
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