Optiflex K1 User Manual

Optiflex K1 User Manual
Operation Manual
Contents
OPTIFLEX®-K1 Setup Illustrations................................................................................................ 2
1. How to use the CPM device.................................................................................................. 3
1.1
1.2
1.3
1.4
Fields of application........................................................................................................... 3
Therapy objectives............................................................................................................. 3
Indications......................................................................................................................... 3
Contraindications............................................................................................................... 3
2.OPTIFLEX®-K1 description..................................................................................................... 4
2.1
2.2
2.3
2.4
Description of the device components............................................................................. 4
Description of the programming unit................................................................................. 5
Explanation of symbols..................................................................................................... 7
Explanation of symbols (connections and nameplate)...................................................... 7
3. Safety information................................................................................................................... 8
4. Adjusting the device ........................................................................................................... 11
4.1 Connecting the device, performance check................................................................... 11
4.2 Adjusting the device to the femur length ....................................................................... 11
4.3 Adapting the leg support assemblies/footplate.............................................................. 12
5. Setting the treatment values............................................................................................... 13
5.1
5.2
5.3
5.4
5.5
General information on programming OPTIFLEX®-K1................................................... 13
OPTIFLEX®-K1 standard models programming............................................................. 14
Treatment value details – standard models.................................................................... 15
Programming OPTIFLEX®-K1 Comfort models.............................................................. 17
Protocol details – Comfort models.................................................................................. 18
6. Care, Maintenance, Transport............................................................................................. 21
6.1 Care................................................................................................................................. 21
6.2 Maintenance (fuse replacement) .................................................................................... 22
6.3 Transport ........................................................................................................................ 22
7. Environmental Protection Statement.................................................................................. 23
8. Specifications ...................................................................................................................... 23
9. IEC 60601-1-2:2001............................................................................................................... 24
9.1 Electromagnetic emissions............................................................................................. 24
9.2 Electromagnetic immunity .............................................................................................. 25
9.3 Recommended Separation Distances............................................................................. 27
10. How to reach us.................................................................................................................... 27
11. Technical service.................................................................................................................. 28
11.1 Technical hotline............................................................................................................ 28
11.2 Shipment........................................................................................................................ 28
11.3 Spare parts.................................................................................................................... 28
1
OPTIFLEX®-K1 Setup Illustrations
A
B
C
D
E
F
G
H
2
1. How to use the CPM device
1.1 Fields of application
1.3 Indications
OPTIFLEX®-K1 is a motor-operated
Continuous Passive Motion (CPM)
device used to mobilize 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
-a
rthrotomy and arthroscopy procedures in combination with synovectomy, arthrolysis or other intra-articular
interventions
1.2 Therapy objectives
-m
obilization of joints in anesthetized
patients
CPM therapy with OPTIFLEX®-K1
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 functional result.
-o
perative treatment of fractures,
pseudoarthrosis and osteotomy
-c
ruciate ligament replacement or
reconstruction
- endoprosthetic implant
Other objectives of therapy include:
1.4 Contraindications
- improvement of joint metabolism
- prevention of joint stiffness
Do NOT use OPTIFLEX®-K1 on
patients with:
-p
romotion of the regeneration and
healing of cartilage and damaged
ligaments
- faster hematoma/fluid resorption
-a
cute inflammatory processes in
the joints, unless on the order of
a physician
- improved lymph and blood circulation
- spastic paralysis
- thrombosis and embolism prophylaxis
- unstable osteosynthesis
3
2. OPTIFLEX®-K1 description
The motorized CPM device permits
extension and flexion of the knee joint
in the range of -10°/0°/120°, and of the
hip joint in the range of 0°/7°/115°.
10. Fuse cap These are some of the outstanding
OPTIFLEX®-K1 features:
13. Programming unit
11. Power switch (ON/OFF)
12. Nameplate
14. Patient chip card1
- anatomically correct setup
15. C
ompartment for storage of
programming unit
- physiological movements
-p
rogramming unit for precise
adjustment of patient-specific
therapy parameters
-s
ymbols for easy operation of the
programming unit
-p
rogrammed therapy parameters
saved to chip card
Biocompatibility
The parts of the OPTIFLEX®-K1 device
that come in contact with the patient
during the intended use, are designed
to fulfill the biocompatibility requirements of the applicable standards.
2.1 Description of the
device components
1. Thigh length scale (femur length scale)
2. T
high length fixation screws
(femur length)
3. K
nee hinge
4. Calf length fixation screws
(tibia length)
5. C
alf length scale (tibia length scale)
6.Footplate angle fixation screw
7. T
ightening screw for adjusting foot
place rotation and to allow removal
of foot plate.
8. C
onnection for programming unit
9. Connection for power cord
4
1
O
PTIFLEX®-K1 devices
with patient chip card only.
2
O
PTIFLEX®-K1 Comfort devices only.
2.1 Device description (continued)
1
2
3
5
4
6
15
7
2
1
10
13
5
4
12 8
11
9
2.2 D
escription of the programming unit
2.2.1 Programming unit in normal mode
patient chip card1
selected angle of the
CPM device
selected therapy
protocol
therapy timer
set extension value
set flexion value
selected direction
of motion
parameter keys
MENU key
START key
“+” (plus) key
“-” (minus) key
STOP key
1
5
O
PTIFLEX®-K1
devices with patient
chip card only.
2.2.2 Programming unit in MENU selection mode
selected
MENU level
set angle of
the CPM device
set extension
value
set flexion value
parameters
available for
selection,
corres­ponding
selection keys
2.2.3 Programming unit in programming mode
set value of
selected function
(here: flexion
angle)
selected function
selected
parameter
(here: flexion)
6
2.3 Explanation of symbols
Standard protocols:
Comfort protocols:
extension
(stretching the knee)
stretch extension
stretch flexion
workout protocol
speed
Comfort protocol
warm up protocol
EROM
repeat extension
extension pause
flexion pause
therapy timer
flexion
(bending the knee)
EMS control
therapy
documentation
reverse on load
(feature for patient
safety)
transport setting
new patient
total therapy time
EROM
repeat flexion
2.4 E
xplanation of
symbols
(connections and
nameplate)
protective earth
connection
type B applied part
power switch OFF
power switch ON
service menu
Refer to accompanying
documents
7
Do not dispose product
with unsorted household or municipal waste.
3. Safety information
Introduction and definitions
Safety information
Read the safety statements before use
of the CPM device. The safety statements are classified as follows:
DANGER!
Explosion hazard –
Indicates an imminent hazard. If
not avoided, this hazard will result
in death or serious injury.
OPTIFLEX®-K1 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.
DANGER!
WARNING!
Indicates a hazard. If not avoided,
this hazard can result in death or
serious injury.
WARNING!
Patient hazard –
-O
nly authorized individuals
are allowed to operate the
OPTIFLEX®-K1 device.
Indi­vi­duals are authorized after
receiving training in the operation
of the device and reading this
operation manual.
CAUTION!
Indicates a potential hazard. If
not avoided, this hazard can result
in minor personal injury and/or
product/property damage.
-B
efore 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.
-B
efore therapy, a test run
consisting of several exercise
cycles must be completed, first
without and then with the patient.
Check that all fixation screws are
tightened.
-S
top therapy immediately,
when you have doubts about the
device settings and/or the therapy
protocol.
8
WARNING!
-D
o not allow parts of the body
or objects (such as blankets,
cushions, or cables) to get caught
in the moving parts of the CPM
device.
Patient hazard –
- It is important that the patient‘s
position is anatomically correct.
Therefore, carefully verify the
following settings/positions:
1.
2.
3.
4.
femur length
knee joint axis
tibia length and leg rotation
leg support assemblies
1
-M
ovements must not cause pain
or irritation.
-P
atients must be fully conscious
while being instructed in the use
of the CPM device and during therapy.
-O
nly the responsible physician
or therapist is able and allowed
to choose the therapy parameters and protocols to use. It
is the physician‘s or therapist‘s
decision whether or not to use the
CPM device on a specific patient.
-T
he patient must be familiar with the functions of the
OPTIFLEX®-K1 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.
-A
fter data storage, write the
patient‘s name on the patient
chip card. The card should only
be used for this patient.
If the patient chip card is used
for another patient, be sure to
delete the previous patient‘s
data from the card first
(see: section 5.2 Programming:
“New Patient”).
Use original chip cards only.1
-A
ny accessories used with
OPTIFLEX®-K1 must first be
approved by DJO.
9
O
PTIFLEX®-K1 devices with
patient chip card only
WARNING!
hock hazard –
S
Strictly observe the following
warnings. Failure to do so endangers
the lives of the patient, the user and
other persons involved.
- Allow OPTIFLEX®-K1 to reach
room temperature before use. If
the device has been transported
at temperatures below 0 °C/
30°F), leave it to dry at room temperature for about 2 hours, until
any condensation has disappeared.
-T
he OPTIFLEX®-K1 device must
only be operated in dry rooms.
-W
hen disconnecting the device
from the power line, remove the
plug from the wall outlet first,
before disconnecting the cable
from the device.
-W
hen 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
DJO, if you have questions in this
matter.
-D
o not use multiple portable
socket outlets (MPSO) to connect the device to the power line.
OPTIFLEX®-K1 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 by 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.
CAUTION!
Preventing chafing and pressure
sores – When your patient is adipose,
very tall or very short, be sure to
prevent chafing and pressure sores.
Place the leg concerned in a moderate abduction position, if deemed
appropriate.
- Liquids must not be allowed
to enter the CPM device or the
programming unit. If liquids have
entered into the devices,
OPTIFLEX®-K1 must be immediately checked by a service technician, before it can be reused.
CAUTION!
Equipment damage –
WARNING!
Equipment malfunction –
-M
agnetic 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 and radio systems 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.
- Refer repair and maintenance to
authorized persons.
- Route all cables below the device
frame to either side, ensuring
that they cannot get caught by the
moving parts during operation.
- Inspect OPTIFLEX®-K1 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.
10
-C
heck that the voltage and
frequency ratings of your local
power line are those indicated
on the nameplate.
-T
he leg support element withstands a maximum continuous
load of 20 pounds.
-D
o not allow any objects (such
as blankets, cushions, or cables)
to get caught in the moving parts
of the CPM device.
-D
o not expose the
OPTIFLEX®-K1 device to
direct sunlight, because some
of the components may reach
inadmissibly high temperatures.
4. Adjusting the device
Adjustment with programmed chip
card.
4.1 Connecting the
device, performance
check
Insert the original patient chip card (21)
into the programming unit (20).
Press the START key.
1. Connect the power cord to socket
(16) of the device and mains plug to
a wall outlet with a non-fused earthed
wire (100 to 240 Volt, 50/60 Hz).
The CPM device automatically enters
the home position.
2. Turn the power switch (18) on.
Performance check
3. F
ollow these steps to set the carriage
to the home position.
If the programming unit can be
operated as described above and
OPTIFLEX®-K1 enters the home position (for home position values,
refer to sections 5.3 and 5.5), the device
has passed the performance check.
OPTIFLEX®-K1
without patient chip card
Press the MENU key on the
pro­gram­ming unit until you reach
program level 3 (standard model)
or program level 5 (Comfort model).
The device also runs performance
checks regularly during operation. This
is what happens, if a problem is identified:
- An audio signal sounds.
- The device switches off immediately.
- The message “ERR”, accompanied by
a code number (e.g. ERR 5), appears
on the display.
Press the “New Patient” parameter key.
Press the START key. The CPM device
automatically enters the home position.
In this situation, you may attempt to
restart the device by turning the device
briefly 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.
OPTIFLEX®-K1
with patient chip card
Initial adjustment for new patients
Insert the original patient chip card (21)
into the programming unit (20).
4.2 A
djusting the device
to the femur length
Press the MENU key on the pro­
gramming unit until you reach
program level 3 (standard model)
or program level 5 (Comfort model).
Press the “New Patient” parameter key.
1. M
easure the length of the patient‘s
thigh (femur) from the greater
trochanter to the lateral knee joint
cavity (Fig. A).
Press the START key. The CPM
device automatically enters the home
position.
2. S
et the carriage to the home position
(see 4.1).
11
3. S
et the measured value at the
femur scale (3) of the carriage.
- T
o adjust the height of the support
assemblies for calf (1) and thigh (6),
loosen clamping levers (2) and (7)
(Figs. E/F).
- Loosen the two fixation screws (4).
- Extend the scale (3) to the required
length.
2. P
lace the patient’s leg on the carriage
and repeat the steps outlined under
1 above to adjust the device to the
patient.
-T
ighten the fixation screws (4) to
set the scale to the new length.
CAUTION!
Equipment damage –
CAUTION!
Do not attempt to extend the
femur scale beyond the stop.
Equipment damage –
Cover the leg support assemblies
with disposable tissues when
using OPTIFLEX®-K1 immediately
after surgery. This helps prevent
discoloration.
4.3 Adapting the leg
support assemblies/
footplate
CAUTION!
1. S
et the leg support assemblies and
the footplate (1, 6, 11) to the expected
positions before accommodating the
patient.
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. G).
- L
oosen fixation screws (8) to adjust
the footplate (11) to the length of the
patient‘s lower leg (Fig. C).
Loosen clamping lever (13) and
adapt the footplate‘s rotation and
height to the patient (Fig. D).
Symbol 1:
Measurement of the
patient‘s femur length
from the grea­ter
trochanter to the
knee joint cavity
Loosen fixation screw (12) and adapt
the angle to the patient‘s foot (turn
the screw a few revolutions until the
footplate can be easily adjusted).
For short patients you can reverse
the footplate‘s bracket 180° (Fig. H)
to adapt the footplate to shorter
calves:
Symbol 2:
Set the carriage to
the home position
(see 4.1) and adjust
it to the measured
femur length.
•L
oosen clamping lever (13) and
remove the footplate (11).
• Loosen the fixation screws (12).
• Reverse the bracket 180°.
•S
crew the footplate to the bracket
and tighten the clamping lever.
Symbol 3:
Adjust height of calf
and thigh support
assemblies. Adjust
the footplate to the
height and length of
the lower leg.
Note!
When reversing the footplate,
ensure that the pins below the
clamping lever engage with the
recesses in the bracket.
12
5. Setting the treatment values
This is what happens when you press
one of the parameter keys to select a
parameter:
WARNING!
Patient hazard –
-T
he corresponding symbol appears on
the display in a larger format.
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.
-T
he set value is displayed.
-T
he symbol above the parameter
key appears in reverse video.
4. W
ith the +/- keys (plus/minus) you
change the displayed value. When
you press and hold the key, the
value will change at a higher rate.
Note!
See also 2.2 and 2.3.
Some of the (special) functions will
only be enabled and disabled. This is
done by pressing the corresponding
parameter key or with the +/- keys.
Activated parameters are identified
with a check mark in the circle next
to the symbol.
5.1 General information
on programming
OPTIFLEX®-K1
1. You activate the programming mode
by briefly pressing the MENU key on
the programming unit.
5. H
aving programmed all parameters,
press the STOP key to save the
values.
2. The various treatment parameters
and functions are allocated to three
(standard model) or five (Comfort
model) programming levels (four per
level).
6. T
hen press the START key to start
therapy.
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.
3. Y
ou 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.
13
5.2 P
rogramming
OPTIFLEX®-K1
standard models
Note!
- R
efer to sections 5.3 and 5.5 for
a description 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.
Different programming levels are provided to program the OPTIFLEX®-K1
Standard models.
You change between levels by pressing
the MENU key.
-T
o prevent accidental changes of
the parameter settings, you can
lock the keys. To do so, simultaneously press keys + and – for
approx. 3 seconds.
The display always indicates on which
level you are.
The following treatment values,
settings and information can be
entered/viewed on the programming
unit (20):
Press both keys again for approx.
3 seconds to unlock.
LEVEL 1:
-S
electing the “New Patient”
function will automatically delete
the data on the patient chip card.
When you have finished programming the unit and press the STOP
key, the settings will automatically
also be saved to the patient chip
card.
-e
xtension
(stretching the knee) - flexion (bending the knee) - speed - warm up protocol - E
mergency stop function:
OPTIFLEX®-K1 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.
LEVEL 2:
MENU
- extension pause - flexion pause - therapy timer - reverse on load (feature
for patient safety)
atients with a programmed chip
P
card
MENU
- Insert the chip card (the patient is not
yet positioned on the CPM device).
LEVEL 3:
-P
erform the mechanical adjustments
of the CPM device (femur length, etc.).
- transport setting - new patient -P
osition the patient on the CPM device
and press the START key to initiate
therapy.
- total therapy time - Service menu 14
Note!
Note!
- W
hile you adjust the extension/
flexion values, the CPM device
will move to the set range. This
allows you to easily and quickly
determine the ROM where the
patient does not experience pain.
- Special functions can be
programmed and retrieved
with OPTIFLEX®-K1 Comfort
devices (see sections 5.4 and 5.5).
- Only OPTIFLEX®-K1 chip card
models allow therapy protocols to
be saved to an inserted chip card.
n speed
The speed can be adjusted between
5% and 100% in steps of 5%.
default setting: 50%
n warm up protocol
During warm up, the patient will
slowly become used to the set
maximum extension and flexion
values, starting from the middle
position.
5.3 Treatment value
details – standard
models
The warm up protocol starts in the
middle between the two maximum
values set for stretching and bending.
The range of motion increases with
each cycle, until the programmed
maximum values are reached after
a total of 15 cycles.
default setting: disabled
You access the different programming
levels by repeated depressions of the
MENU key.
-Y
ou select the treatment parameters
with the corresponding parameter key.
LEVEL 2:
-Y
ou change the treatment values with
the +/- keys and you enable/disable
functions by pressing the corresponding
parameter key again.
n extension pause
P
auses occur at the extension limit,
just before the bending movement
starts. Pauses can be set to any
value between 0 and 59 seconds in
steps of 1 second, and to values
between 1 and 59 minutes in steps
of 1 minute.
default setting: no pause
-Y
ou save the settings by pressing
the STOP key.
LEVEL 1:
ne
xtension (stretching)
n flexion pause
-m
aximum knee extension:
-10 degrees
Pauses occur at the flexion limit,
just before the stretching movement
starts. Pauses can be set to any
value between 0 and 59 seconds in
steps of 1 second, and to values
between 1 and 59 minutes in steps
of 1 minute.
default setting: no pause
-m
aximum hip extension:
7 degrees
he programmed value and the
T
value measured at the patient‘s
knee may deviate slightly.
n flexion (bending)
-m
aximum knee flexion:
120 degrees
-m
aximum hip flexion:
115 degrees
15
n therapy timer
LEVEL 3:
Default setting is continuous
operation of the carriage.
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.
n transport setting
W
ith this function, the carriage will
move to a position optimally suited
for packing the CPM device. Set the
femur length on 49 inches and the
lower leg on 45 inches.
Select the function and press the
START key. The carriage moves to
the transport position. (see 6.3) However, you can also select therapy
durations of 1 to 59 minutes in steps
of 1 minute and of 1 to 24 hours in
steps of 30 minutes.
When the time has elapsed, the
device switches automatically off
and stops in the position:
extension + 10°. In this case, a circle
replaces the clock symbol. The circle
fills as the therapy time progresses.
n 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.
n r everse on load feature
for patient safety
With OPTIFLEX®-K1 devices with
patient chip card, the factory defaults
will be restored. All values stored on
the chip card will be deleted.
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. At level 1, very low
resistance will cause the device to
reverse; at level 25, a high resistance
is required to initiate the reversal.
default setting: level 25
The carriage will stop in the home
position.
The “New Patient” function
(home position) selects the
following settings:
- extension:
25°
- flexion:
35°
CAUTION!
- speed:
50%
Patient hazard –
- warm up:
disabled
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.
- extension pause:
0
- lexion pause:
0
16
- timer:continuous
operation
- reverse on load::
25
- total therapy time:
0
n total therapy time
The following treatment values,
settings and information can be
entered/viewed on the programming
unit (20):
OPTIFLEX®-K1 models
without patient chip card
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.
LEVEL 1:
-e
xtension
(stretching the knee) Under menu item “total therapy time”
of OPTIFLEX®-K1 models with chip
card you can view each patient‘s
total therapy time (duration of all the
patient‘s therapy sessions).
- flexion (bending the knee) - speed Deleting the stored therapy time
Press and hold the parameter key for
5 seconds or select the New Patient
function.
- warm up protocol LEVEL 2:
MENU
n Service MENU
- extension pause For service purposes only, refer to
Service Manual.
- flexion pause - therapy timer - reverse
­
on load
(feature for patient safety) Reminder:
You save the set parameter values
by pressing the STOP key.
LEVEL 3:
MENU
- stretch extension 5.4 P
rogramming
OPTIFLEX®-K1
Comfort models
- stretch flexion - workout protocol - Comfort protocol OPTIFLEX®-K1 devices of
the Comfort series offer two more
programming levels for additional
functions.
The programming levels are selected
in the same way as with the standard
models.
LEVEL 4:
MENU
- EROM repeat extension - EROM repeat flexion - total therapy time
Programming levels 1 and 2 are identical
with programming levels 1 and 2 of the
standard models.
Continued on next page.
All special functions are disabled upon
delivery and in the “New patient” mode.
17
MENU
ubsequently the carriage reverses
S
5 ° toward the flexion angle and then
moves very slowly back again to the
programmed extension limit (display
<=). After that it attempts to stretch
the joint another 5 °, moving even
slower than before (display <<).
LEVEL 5:
- transport setting - new patient If a high resistance toward the additional 5 ° is sensed, the reverse on
load function is automatically activated and the carriage moves in the
opposite direction.
- therapy documentation - Service menu This stretch cycle is repeated 10
times. After that the carriage moves
to the programmed flexion limit and
restarts the stretch extension cycle.
5.5 Protocol details –
Comfort models
It is not possible to activate the special “stretch extension” and “stretch
flexion” functions at the same time.
-Y
ou access the different programming
levels by repeated depressions of the
MENU key.
-Y
ou select the treatment parameters
with the corresponding parameter
key.
Note!
-Y
ou change the treatment values with
the +/- keys and you enable/disable
functions by pressing the corresponding
parameter key again.
If an extension pause has been
programmed, the carriage will stop
for the pause each time the maximum stretching value is attained.
-Y
ou save the settings by pressing
the STOP key.
n stretch flexion
All special functions are disabled upon
delivery and in the “New patient” mode.
With the special “stretch flexion”
function the joint will be gently stretched beyond the flexion limit.
Starting at the middle position the
carriage will first move to the programmed extension limit and then
to the programmed flexion limit.
Note!
LEVEL 1: equivalent to level 1 of
the standard model (see: 5.3)
LEVEL 2: equivalent to level 2 of
the standard model (see: 5.3)
Subsequently the carriage reverses
5 ° toward the extension angle and
then moves very slowly back again to
the programmed flexion limit (display
=>). After that it attempts to stretch
the joint another 5 °, moving even
slower than before (display >>).
LEVEL 3:
n stretch extension
If a high resistance toward the
additional 5° is sensed, the reverse
on load function is automatically activated and the carriage moves
in the opposite direction.
This stretch cycle is repeated 10
times. After that the carriage moves
to the programmed extension limit
and restarts the stretch flexion cycle.
With the special “stretch extension”
function the joint will be gently
stretched beyond the extension limit.
Starting at the middle position the
carriage will first move to the
programmed flexion limit and then
to the programmed extension limit.
18
The device switches off, when the
protocol has been completed.
It is not possible to activate the
special “stretch flexion” and “stretch
extension” functions at the same time.
The indicated minutes are approximate
values. Depending on the programmed
maximum range of motion, the times
may vary.
Note!
n Comfort protocol
If a flexion pause has been programmed, the carriage will stop for
the pause each time the maximum
stretching value is attained.
With the special “Comfort” function,
the range of motion is gradually
ex­tended until the patient attains the
maximum programmed extension
and flexion values.
For this protocol, the maximum values
are programmed first, then the special
function is activated and, eventually,
the treatment is started.
OPTIFLEX®-K1 Comfort will now
complete five cycles in both directions
with the maximum programmed values
minus 5 °. Then the range of motion
is increased by 1 ° per cycle in both
directions until the programmed limit
values are reached. Once the limit
values have been attained, the CPM
device continues in the programmed
range of motion until the end of the
therapy session.
n workout protocol
With the special “workout” function, a
series of special, programmed proto­cols
can be completed in one session.
The program includes the following
protocols in a given sequence:
warmup, stretch extension, EROM
repeat extension, stretch flexion,
EROM repeat flexion, and cool-down.
The entire workout protocol takes
approx. 38 to 40 minutes to complete.
Protocol stages:
LEVEL 4:
-5
-minute protocol: warmup
Starting from the middle position,
the range of motion is gradually
increased toward extension and
flexion in steps of 1 °
n EROM repeat extension
The special “EROM repeat extension”
function allows a more efficient exercise in the last 10 ° before the set
maximum extension value.
For this protocol, the CPM
device starts in the middle
between the set extension
and flexion values. It will first
move to the programmed
flexion value and then to the
programmed extension value.
When the extension value has
been reached, the carriage
reverses 10 ° toward the flexion angle and then moves
back again to the maximum
extension value. The movement through the final 10 ° is
repeated
five times at a slow speed.
-5
-minute exercise according to
programmed settings
- 5-minute protocol: stretch flexion
-5
-minute protocol: EROM repeat
flexion
- 5-minute protocol: stretch extension
- 5-minute protocol: EROM repeat
extension
- 5-minute exercise according to
programmed settings
-3
-minute protocol: cool-down
The cool-down protocol is the
warm-up protocol of the workout
mode reversed. Starting from the
maximum values, the carriage
reduces the range of motion by
1 ° per cycle, until the middle
position is reached.
At the end of the cycle, the carriage
will again move to the maximum
flexion value and then starts another
cycle with five repetitions through
the last 10 ° of the extension angle.
19
n EROM repeat flexion
LEVEL 5:
The special „EROM repeat flexion”
function allows a more efficient exercise in the last 10 ° before the set
maximum flexion value.
n transport setting
With this function, the carriage will
move to a position optimally suited
for packing the CPM device. Set the
femur length on 49 inches and the
lower leg on 45 inches.
Select the function and press the
START key. The carriage moves to
the transport position. (see 6.3)
For this protocol, the CPM device
starts in the middle between the
set extension and flexion values.
It will first move to the programmed
extension value and then to the
programmed flexion value.
When the flexion value has been
reached, the carriage reverses 10 °
toward the extension angle and then
moves back again to the maximum
flexion value. The movement through
the final 10 ° is repeated five times
at a slow speed.
n 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 carriage moves to the home position.
At the end of the cycle, the carriage
will again move to the maximum
extension value and then starts
another cycle with five repetitions
through the last 10 ° of the flexion
angle.
With OPTIFLEX®-K1 devices
with patient chip card, the factory
defaults will be restored. All stored
values will be deleted.
The carriage will stop in the home
position.
n total therapy time
The New Patient (home position)
function selects the following settings:
OPTIFLEX®-K1 models without
patient chip card
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.
- extension:
25°
- flexion:
35°
- speed:
50%
- warm up:
disabled
Under menu item “total therapy time”
of OPTIFLEX®-K1 models with chip
card you can view each patient‘s
total therapy time (duration of all the
patient‘s therapy sessions).
- extension pause:
0
- flexion pause:
0
Deleting the stored therapy time
Press and hold the parameter key for
5 seconds or select the New Patient
function.
- r everse on load:
- timer:continuous
operation
25
- total therapy time:
0
- stretch extension:
disabled
- stretch flexion:
disabled
-E
ROM repeat
extension: disabled -E
ROM repeat flexion: disabled
20
- Comfort protocol:
disabled
- workout protocol:
disabled
- therapy
documentation:
reset
n therapy documentation
n Service menu
OPTIFLEX®-K1 devices of the
Comfort series with patient chip
card have a special documentation
function which provides a log of all
therapy sessions.
The carriage run times as well as
the range of motion of the sessions
are recorded.
The collected data are presented
graphically in the form of a coordinate
system (X-axis = range of motion/
Y-axis = time) where the upper curve
illustrates the trend of the flexion
movement and the lower curve the
trend of the extension movement.
For service purposes only, refer to
Service Manual.
Reminder:
You save the set parameter values by
pressing the STOP key.
6. Care, Maintenance, Transport
6.1 Care
CAUTION!
WARNING!
Equipment damage –
- The plastic material used is not
resistant to mineral acids, formic
acid, phenols, cresols, oxidizing
agents and strong organic or
inorganic acids with a pH value
below 4.
Shock hazard –
Unplug the device from the power
line before cleaning.
Shock hazard, equipment damage –
Liquids must not enter the device
or the programming unit.
- U
se only clear disinfectants
to prevent discoloration of the
device.
- Do not expose the CPM device
to strong ultraviolet radiation
(sunlight) and fire.
-O
PTIFLEX®-K1 can be disinfected by
wiping down with a disinfectant. Thus,
it complies with the special hygiene
standards for medical
technical equipment.
-T
he enclosure and removable leg
support assemblies can be cleaned
with commonly used disinfectants
and mild household detergents.
-U
se only a damp cloth to wipe
the carriage down.
21
6.3 Transport
6.2 Maintenance
(fuse replacement)
Follow these steps to prepare the
OPTIFLEX®-K1 for transport:
1. A
djust the femur length to 49 inches
and the tibia length to 42 inches.
Check before each use
2. S
elect the “Transport setting”
from the menu
(refer to 5.3 for details).
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.
3. P
ush the power switch to turn off
the OPTIFLEX®-K1.
4. D
isconnect the power cord and the
programming unit.
5. T
he device must be stored in its
original shipping box for transport.
DJO cannot be held liable for
damage in transit, if theoriginal
shipping box was not used.
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.
6. S
et the footplate to a horizontal
position.
7. N
ow slide the polystyrene pads
onto the OPTIFLEX®-K1.
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.
8. P
lace the power cord at the
bottom of the box before inserting
the OPTIFLEX®-K1 including the
polystyrene pads.
The device does not require additional
regular maintenance.
9. Put
the programming unit (20) in the
supplied box, and store both in the
OPTIFLEX®-K1 box.
Fuse replacement
Programming Unit
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).
Fuses used must be T1A fuses.
22
Power cord
7. E
nvironmental protection statement
The product described in this operation manual must not be dispose of with unsorted
household or municipal waste. It requires separate disposal. Please contact DJO for
information about the possible recycling of the product.
8. Specifications
Ambient conditions
(storage, transport)
temperature: -24 ºC to +60 ºC
(-12 °F to +140 °F)
Input ratings:100 – 240 V AC/
50 – 60 Hz
Current
consumption:
850 – 370 mA
Fuses:
2 x T1A
Protection class:
I Applied part:
type B
Max. load
on carriage:
20 pounds
relative humidity:20% to 85%
atmospheric
pressure:700 hPa to
1060 hPa
Ambient conditions (operation)
temperature:
+10 ºC to +40 ºC
(50 °F to +104 °F)
Dimensions
length:
96 inches
width: 35 inches
height:min. 23 inches to
max. 56 inches
relative humidity:30% to 75%
atmospheric
pressure:700 hPa to
1060 hPa
Adjustment ranges (min./max.):
femur range:approx.
31 – 49 inches
Subject to change without notice.
(06/06)
lower leg range:approx.
25 – 57 inches
weight:
11 pounds
materials used: ABS, POM
(Delrin 100),
PUR, PA, FR4,
aluminium, stainless
steel, brass
MPG
class 2a
Standards compliance:
IEC 60601-1:1988 + A1:1991 + A2:1995
Certification:ANSI/UL 60601-1
CAN/CSA C22.2
No. 601.1
23
9. IEC 60601-1-2:2001
The OPTIFLEX®-K1 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.
Portable and mobile RF communication systems may affect the OPTIFLEX®-K1 device.
OPTIFLEX®-K1 should not be
used adjacent to or stacked with
other equipment.
If adjacent or stacked use is necessary, OPTIFLEX®-K1 should be observed to verify
normal operation in the configuration in which it will be used.
9.1 Electromagnetic emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
OPTIFLEX®-K1 is intended for use in the electromagnetic environment specified below. It
is the responsibility of the customer or user to ensure that the OPTIFLEX®-K1 device
is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions to
CISPR 11
Group 1
OPTIFLEX®-K1 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
OPTIFLEX®-K1 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
24
9.2 Electromagnetic immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
OPTIFLEX®-K1 is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that the OPTIFLEX®-K1 device is
used in such an environment.
Immunity test
IEC 60601-test
Compliance level Electromagnetic
level
environment - guidance
Electrostatic
discharge (ESD)
to IEC 61000-4-2
± 6 kV contact
e 6 kV contact
e 6 kV contact
e 8 kV air
e 8 kV air
Electrical fast trane 2 kV for power
sient/burst to IEC
supply lines
61000-4-5± 2 kV for
power supply lines
e 1 kV for input/
output lines
Surges to IEC
61000-4-5
e 1 kV for input/out-
Mains power should be that
of a typical commercial or
hospital environment.
put lines
e 1 kV differential
e 2 kV common
e 2 kV common
mode
mode
Mains power should be that
of a typical commercial or
hospital environment.
mode
< 5% UT
(> 95% dip in UT)
for 5 s
Mains power should be that
of a typical commercial or
hospital environment. If the
user of the OPTIFLEX®-K1
40% UT
device requires continued
(60% dip in UT) for operation during power
5 cycle
mains interruptions, it is
recommended that the
70% UT
OPTIFLEX®-K1 device be
(30% dip in UT) for powered from an uninter25 cycles
ruptible power supply or a
battery.
< 5% UT
(> 95% dip in UT)
for 5 s
3 A/m
3 A/m
< 5% UT
< 5% UT
(> 95% dip in UT ) (> 95% dip in UT )
for ) cycle
for ) cycle
40% UT
(60% dip in UT)
for 5 cycle
70% UT
(30% dip in UT)
for 25 cycles
Power frequency
(50/60 Hz) magnetic
field to IEC 610004-8
supply lines
e 1 kV differential
mode
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines to IEC
61000-4-11
e 2 kV for power
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Power frequency magnetic
fields should be at levels
characteristics of a typical
location in a typical
commercial or hospital
environment. Portable and
mobile RF communications
equipment are used no
closer to any part of the
OPTIFLEX®-K1 device,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
25
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
OPTIFLEX®-K1 is intended for use in the electromagnetic environment specified below.
It is the responsibility of the customer or user to ensure that the OPTIFLEX®-K1 device is
used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment-guidance
Recommended separation
distance:
Conducted RF to
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Radiated RF to
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d =
r
1.2 öP
d = 1.2
800 MHz
r
öP
d = 2.3
2.5 GHz
r
öP
80 MHz to
800 MHz to
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer andd
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 rangeb.
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) F
ield 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 OPTIFLEX®-K1 device is used
exceeds the applicable RF compliance level above, the OPTIFLEX®-K1 device should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the OPTIFLEX®-K1 device.
b) O
ver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
26
9.3 R
ecommended separation distances between portable and mobile RF
communications equipment and the OPTIFLEX®-K1 device
The OPTIFLEX®-K1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the OPTIFLEX®-K1 device
can help prevent electromagnetic interferences by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and
the OPTIFLEX®-K1 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
150 kHz to 80 MHz
d =
r
1.2 öP
80 MHz to 800 MHz
d =
r
1.2 öP
800 MHz to 2,5 GHz
d =
r
2.3 öP
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. How to reach us
Service, warranty or repair, please contact the selling dealer or your local DJO
customer service.
27
11. Technical Service
Surcharges may apply in certain cases
to spare parts ordered in low quantities.
11.1 Technical Hotline
Item Description
Do you have any technical questions?
Do you need technical service?
1.
2.
marker pen for
patient chip card DJO, LLC
1430 Decision St
Vista, CA 92081 USA
T: 1-800-592-7329 USA
T: + 1-317-406-2209
F: + 1-317-406-2014
chattgroup.com
11.2 Shipment
To prevent damage during transport,
only use the original shipping box.
These boxes can be obtained from
DJO.
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.
When ordering spare parts, always
specify:
- item
- description
- part number
- quantity
- serial number of the CPM device
Note!
Refer repairs to authorized,
specially trained staff.
JO offers service training for your
D
personnel.
28
Part No.
patient chip card0.0034.035
0.0031.006
Qty
DJO, LLC
A DJO Global Company
1430 Decision Street
Vista, CA 92081-8553 • USA
T 760.727.1280 • F 760.734.5608
DJOglobal.com
13-7467_A
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