MU Ortomed 4060 CPM Ingles Version 1

Ortomed
4060
CPM Unit
User Manual
Version : 1.1
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Table of Contents

2
2
3
4
4
5
7
7
8
9
12
15
17
19
22
25
28
29
30
30
30
31
33
34
36
37
42
44
General information
Accessories that come with Ortomed
Warnings
Installing / Connecting to the power network
Changing Fuses
Display Language
Ortomed
Characteristics
Control Panel
Display Information
Ortomed Operation
Booting
Use in Manual Mode
Use in Continuous Mode
Use in Program Mode
Programs
Setting of new H parameter
Emergency Stop
Indications
Contraindications
Preventive maintenance, preservation and cleaning
Corrective maintenance
Table of ERRORS
Technical Features
Symbols
Information on Compatibility
Final Considerations
European Representative
MU_4060_English_Rev_1.1_092010
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
General Information
This manual was written to describe the operations of the therapy unit, CPM
(Continuous Passive Motion), ORTOMED model. It has general instructions
for
the
operation,
precaution
instructions
and
maintenance
recommendations.
For maximum life and efficiency of the ORTOMED Carci, we recommend
that you read and understand the whole manual for the due precautions.
Before applying any treatment on a patient, the user must know the
operating procedures, indications, contraindications, hazards and
precautions.
CPM
CPM or Continuous Passive Motion is a postsurgical procedure developed
to help in the patients recovery after a joint surgery.
The Ortomed Knee CPM Unit is normally used in the postsurgical period for
total recovery of the knee and of the Anterior Cross Ligament (ACL). After a
joint surgery, when a patient cannot move it, the tissue near the joint
becomes hard and the tissue has scars, resulting in a joint with limited
movements. On flexing and stretching the joint with controlled and repeated
speed, through an arc of motions indicated during a long period of time, the
Ortomed Knee CPM Unit reduces the contrary effects of immobilization and
of the trauma in the knee joint.
The equipment allows, for example, stimulation of the quadriceps,
movement of the foot dorsiflexion, monitoring of the speed, among other
facilities.
Accessories that come with the device
WARNINGS
Power cable.
Cable to connect the CPM Unit to Ortomed.
UNIT CONTROL ( CPM Unit 4060 )
Thigh and Leg Support.
Foot Support
Band to fasten the feet.
Ortomed User Manual.
Program Maker Software User Manual.
USB Cable
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
CD with the Program Maker software
Read, understand and practice the precaution and operation

instructions of this manual before operating or using the unit.
Extreme caution when using on or near children.
Only use ORTOMED for the purposes determined, as described in this
manual.
Shut off the switch before disconnecting the unit from the power source.
Do not use the chord to disconnect the unit. Hold the power chord from
the base.
Take care when carrying, transporting or storing the ORTOMED unit to
prevent damages to the unit due to falls, improper transport or storage
methods.
The sale of this device in Brazil is restricted to doctors or specialized
professionals.
Ensure that the unit is connected to a suitable power network,
according to the national and local power standards.
Keep the hair, loose clothes, bed linen, fingers and toes away from the
units hinged components.
Always turn off and remove the unit from the socket before performing
services or cleaning.
Take care when using accessories or auxiliary devices like: muscular
stimulators, cold packs and other modalities.
Direct the control wire outside the reach of the ORTOMED moving
mechanism to help prevent damages.
Inconsistent patients or patients under strong influence of a drug must
be constantly followed up or monitored when using ORTOMED.
The ORTOMED unit must be fully visible throughout the time of use.
Never cover the unit with bed linen or any other material that can hide it
during the operation.
The equipment should not be operated outside the temperature range
specified in the technical features since there may be overheating and
safety hazard.
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
The ORTOMED must not be operated near (< 5 meters ) any
equipment of diathermia by short waves.
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Installing / Connecting to the power network

For perfect operation of your equipment, we suggest that the electrical
installations comply with the following standards:
Brazil:
NBR 5410/1990 Low-voltage electrical installations;
NBR13534/1995 Electrical installations in health
establishments Safety requirements.
Other Countries:
IEC 60364-7-7 (10/2002) Electrical Installations medical
locations;
Or another listed standard applied in the country of use.
Place the ORTOMED on a firm, smooth and stable surface to assure
stability of the unit during operation;
Connect the power cable to the tripolar connector located in the back
panel and connect it to the electric power socket;
The Ortomed 4060 uses automatic power source and operates in any
supply voltage between 100V~ and 230V~ and frequency of 50 or 60
Hz.
The power supply voltage must be within the range specified (
10%), otherwise, there can be equipment breakdown and safety
hazard.
Replace the fuse box in the Ortomed.

Connect the power cable to the Ortomed.
Connect the power cable to the power network.
Display language
The ORTOMED allows accessing three display languages:
Portuguese
English
Spanish
If you wish to change the current language, follow the steps below:
1. Connect the CPM Unit to the Ortomed
2. Connect the tripolar power cable to the power and to the
ORTOMED.
3. Connect the ORTOMED through the ON/OFF switch.
4. Press and keep the key pressed

5. Turn on the device the equipment will emit a continuous beep,
displaying the screen:
Changing Fuses
To change the fuses, turn off the device through the ON/OFF switch
and disconnect the power cable from the power network.
Disconnect power cable from the Ortomed.
Using a screwdriver, place it in the slot of the fuse holder and turn it
counterclockwise. Remove the protective box of the fuse.
Check the burned fuse and change it for one of the same value ( 2 A 250 V~ ).
6. Followed by the screen
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED:
7. Release the key

8. Select the language desired through the keys
Characteristics:
9. Press the key

10. The equipment will exit the language selection mode, displaying the
screen:
Select
Extension:
- 10 to 120 ( steps of 5 )
Flexion:
0 to 120 ( steps of 5 )
Extension Delay:
time of rest for extension - 0 to 15 s
Flexion Delay: time of rest for flexion - 0 to 15 s
Speed:
30 % a 100 %.
Mean time of a complete flexion/extension is 140 seconds ( 5% ), at
speed of 100%; and 480 seconds ( 5% ) at speed of 30%;
Remove Patient
Press SET
11. Select the desired H, and proceed according to the instructions of

the item BOOTING, page 14.
12. Or turn off the Ortomed
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Control Panel:
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
3. Programs
1. Booting screen:
PROGRAMS
OSCILLATION
Select
Remove Patient
Press SET
Display Information:
2. Main Menu
Extension
Flexion
Ext Delay
Fl Delay
Speed
CHK.: XXXX Software Registration

NSB.:: AAAAA Serial number of the PCB of the CPM Unit Control.
NS .: BBBBB Serial number of the Ortomed
Rev.: Y.X version of the CPM Unit Control Software
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Description:
Select
Displays the ROM (Range Of Motion) selected for the cursor.

Extension
30
Flexion
90
Remove Patient
Press SET
Displays the values selected for Extension and Flexion.

Ext Delay
5s
Fl Delay
5s
D SN.: BBBBB Serial number of the Ortomed PCB
Rev.: Y.X Version of the Ortomed software
H = 0 Thigh height adjustment position.
OFF 0000 Indicates communication between the Unit Control and
Ortomed .
Displays the times (seconds) selected for rest (Delay) selected for
Extension and Flexion.
Speed
50%
Displays the speed selected (in %).
ON
0
Informs that the support is in motion.
OFF
0
Informs that the support is stationary.
INI
0
Informs that the cursor is in calibration phase
WAIT
0
Extension
Flexion
Ext Delay
Fl Delay
Speed
Informs that the cursor is in direction of Extension = 0

ERROR
0010
Informs the error code.
PROG 0
OFF
0
Informs that there is selected program.
10
11
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED operation:
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Measure the patient

Measure the patient from the hip joint (greater trochanter) up to the knee in
centimeters.
Position the patient according to the figure. The knee's axis of rotation
should coincide with the Ortomed axis of rotation. As shown below.
This measurement is called Height H.

Adjust the height H according to the scale in the Ortomed and table
Height H
cm
37
38
39
40
41
42
43
44
45
Number
0
1
2
3
4
5
6
7
8
Adjust the support of the Foot and Ankle through the handles, as
shown in the figure below.
Through the handle, fix the adjustment of the height H selected.

12
13
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
The patient must be in a comfortable position for the Ortomed to perform
the movements with the knee, as shown in the sequence below:
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Booting:
1. Connect the tripolar power cable to the power and to the
Ortomed.
2. Connect the Ortomed through the ON/OFF switch.
3. The display will show the Start screen:
4. Changing to the screen:
Select
Remove Patient
Press SET
5. Use the keys

to select the value of H according to
the parameters of table H (page 11).
6. Press the
key to start the calibration.
7. The display will show the following screen when in boot mode:
14
15
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
The ORTOMED is ready for:
A. Use in Manual Mode
B. Use in Continuous Mode
C. Use in Program Mode
Select
Remove Patient
Press SET
8. Use in Manual Mode:

The Ortomed moves the support in the direction of maximum flexion up to
the end of the course. Displaying the screen:
The manual mode allows selecting the direction (extension or

flexion) That is:
Select the speed, direction and angle and press the
Procedure for manual use:
8.1.
After booting, the display will show the screen:
Extension
Flexion
Ext Delay
Fl Delay
Speed
Extension
Flexion
Ext Delay
Fl Delay
Speed
The Ortomed moves the support in the direction of extension. When the
angle of extension reaches zero degree (0), the support stops, and the
display shows the screen:
Extension
Flexion
Ext Delay
Fl Delay
Speed
key.
8.2.
16
Through the
and
keys, select the
values of Extension, Flexion and Speed desired.
Example:
Extension = 30, Flexion = 90 and Speed = 50%
17
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Extension
Flexion
Ext Delay
Fl Delay
Speed
8.3.
Extension
Flexion
Ext Delay
Fl Delay
Speed
Position the cursor in Extension = 30 and press the

key. The support will move up to the initial angle
selected. The ROM (Range of Motion) selected from 30 to
90 and the speed of 50% in manual mode is ready.
The support will move up to Flexion angle = 90

8.5.
In case there is need to increase or reduce the angles of

Flexion, Extension and speed, position the cursor in
Flexion, Extension or speed, select the new parameter,
position the cursor in the desired direction, press the
key.
9. Use in Continuous Mode
Extension
Flexion
Ext Delay
Fl Delay
Speed
8.4.
The Continuous mode allows selecting the speed and Extension

and Flexion angles; and starting the support movement
continuously in the direction Extension
Flexion
Extension.
That is:
To move the support up to Flexion = 90, position the cursor in
Flexion = 90 and press the
key.
18
Procedure for continuous use:

9.1. After booting, the display will show the screen:
19
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
9.3.
Extension
Flexion
Ext Delay
Fl Delay
Speed
9.2.
Extension
Flexion
Ext Delay
Fl Delay
Speed
Through the
and
keys, select the
values of Extension, Flexion and Delay (Extension and
Flexion) and Speed desired. Example:
Extension = 10, Flexion = 100, Extension Delay = 5 s,
Flexion Delay = 10 s, and Speed = 60%
Extension
Flexion
Ext Delay
Fl Delay
Speed
Press the
key. The support will go up to the
Flexion position = 10 selected.
9.4. After the support is positioned in the Flexion position = 10,

press the
key again. The support will move continuously
according to the parameters selected.
Extension
Flexion
Ext Delay
Fl Delay
Speed
20
21
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
9.5.
There being the need to stop movement, press the

key.
9.6.
To restart movement, press the

will move up to the Extension selected.
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
10.1. To select the desired program, press the
display will show the screen:
key. The support
Extension
Flexion
Ext Delay
Fl Delay
Speed
10.2. Through the
key10.3. Press the
9.7.
Press the
movement.
key. The
keys, select the program desired.
key again. The support will restart the
10. Use in Program Mode

The Program mode allows selecting through the
key the
programs recorded in the memory of the CPM Unit, through the
Program Maker software.Procedure for use of the Programs:
22
23
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
10.6. To disable the selected program, press the
key,
and the
key twice.
10.7. The display will show the screen:
Extension
Flexion
Ext Delay
Fl Delay
Speed
Extension
Flexion
Ext Delay
Fl Delay
Speed
10.4. To start movement, press the

key.
10.5. The support will start the programs movement.
10.8.
NOTE: In case of discomfort to the patient, press the

and remove the patient from the Ortomed.
Extension
Flexion
Ext Delay
Fl Delay
Speed
OFF
key
Programs
The display informs that the CPM Unit has selected program:
PROG 0
After exiting the selected program, the Ortomed can be

sued in the Manual or Continuous modes.
0
24
Through the ORTOMED PROGRAM MAKER software, the user can record
and delete specific Protocols.
Consult the ORTOMED PROGRAM MAKER SOFTWARE user manual
The Program Maker software has 5 specific programs that can have the
parameters changed through the software, and the FREE program, which
allows ample programming of the parameters desired:
25
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Program 1: LCA
Description:
Evolves from 5 to 5, with the programmed pauses
Extension = - 5
Flexion = 100
Extension Delay = 20 seconds
Flexion Delay = 10 seconds
Speed = 30%
Step = 5 Program 2: Total Arthroplasty

Description:

Extension = - 5
Flexion = 90
Speed = 30%
Step = 5
Program 3: LCP
Description:
Extension = 0
Flexion = 60
Speed = 30%
Step = 5
Program 4: ROM
Description:
Extension = 0
Flexion = 90
Speed = 30%
Step = 5
Program 5: Oscillation
Description:
There will be three oscillations in the last 5 to reach the
Flexion and Extension selected. That is:
0 -> 5 -> 0 -> 5 -> 80 -> 85 -> 80 -> 90
Extension = 0
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ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Flexion = 90
Speed = 40 %
Step = 5
Specific programs can be recorded using the Program Maker software.
IMPORTANT: Ortomed does not allow functioning of the Ortomed
Program Maker with the CPM Unit connected to the Ortomed
If the user connects the CPM Unit to the Ortomed and also to the
Ortomed Program Maker software, the display will display the
message:
Application Not
Allowed
To Program
Disconnect ORTOMED
Consult Manual
To use the Ortomed, disconnect the USB cable from the CPM Unit and
press the
key
The Ortomed will enter the boot screen.
27
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Adjusting a New Parameter H :
The Ortomed allows selecting a new parameter H without the need to
reboot.
Changing parameter H:
1. To change parameter H, position the cursor in Flexion with angle equal
to 45.
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Emergency Stop:
1. In case there is need to stop the therapy, the patient will stop the
Ortomed immediately by pressing one of the switches, as shown in figure A.
The Unit Control will emit two Beeps, and display the ERROR 020 message.
key, and the
To restart movement, press the
the support to the return to the selected position of the Extension.
keys at the same time, the parameter H will

2. Press the
be enabled to be changed.
3. Use the keys to select the new parameter H.
4. Press the
main menu.
keys at the same time to return to the
Press the
key for
key again to start the movement again.
2 . If the value of H selected in the UNIT CONTROL is greater than that set
in the Ortomed (figure C), the support rod when in Extension direction can
activate the emergency stop (figure B), stopping the movement.
The UNIT CONTROL will emit two Beeps, and display the ERROR 020
message. Turn off the Ortomed, position H in the value desired, turn on the
Ortomed and select the same value of H in the UNIT CONTROL.
Figures:
keys and the parameter H is not

On pressing the
enabled, the display will show the ERROR 0040 message.
On pressing the
keys and the parameter H is not enabled,
check if the Flexion angle is less than 45. Proceed according to item 1
28
Figure A
Figure B
Figure C
29
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Indications
The use of Ortomed is indicated for rehabilitation of the knee and hip in:
Postsurgical recovery from surgeries via laparoscopy
Reconstruction of the knee (ligaments and meniscus)
Fractures ( patellar, femoral, tibial plateau )
Surgeries of the hip
Burns
Joint mobilization
Contraindications
The use of Ortomed must be avoided or suspended definitively or
temporarily in cases of:
Relative contraindications:
Deep venous thrombosis (prevention)
Arthritis and arthrosis
Lesions of the meniscus, with presence of free intra-articular
bodies
Degenerative bone diseases
Vascular lesions
Acute edemas
Lesions in conjunctive tissue
People with difficulties to understand should only use the
device under supervision
Absolute contraindications:
Lesions with total and/or partial loss of sensitivity
Flaccid, spastic phase neurological lesions
Lesions in acute phase of evolution
Non-consolidated fractures
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
This equipment has an estimated service life of 5 years. After this
period, we recommend subjecting the equipment to a full inspection
by CARCI in order to continue using it safety and efficiently.
Cleaning.
Whenever required, clean the equipment using a cloth wet with
water and soap. Always ensure that the device is disconnected
from the power supply before cleaning and avoid wetting the
electrical contacts of the wires and connectors.
Important observations:
Corrective maintenance of this equipment, in addition to those
prescribed above, must be conducted by authorized technical

assistance from CARCI only.
Electrical diagrams, circuits and parts lists are not supplied to the
end consumers. If necessary, contact the Carci Authorized
Technical Assistance.
Use of parts and accessories not specified by CARCI can
compromise equipment safety. CARCI will not be held liable for
such procedure.
Corrective maintenance
The Ortomed cannot be turned on
once a year by the factory or authorized technical service.

Always check, before use, if there are no damages in the manual
control cable and in the power cable.
30
Preventive maintenance.
We recommend that the ORTOMED be inspected and calibrated
Solutions
Problem
The Ortomed displays the main

screen,
the boot set screen, but does not
boot.
The Ortomed displays ERROR 01 or 02
Check if the power cable is connected to the

power network;
Check if the ON/OFF switch is in the correct
position;
Check if the protective fuses are not open;
Check the integrity of the power cable.
Check if the display shows one of the
ERRORS: 8 or 10.
If yes, turn the ON/OFF switch on and off
and restart the process.
If the problem persists, contact the
technical assistance.
Turn the ON/OFF switch off and on and
restart the process.
31
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
The Ortomed displays ERROR 03
The Ortomed displays ERROR 05 or 06
Contact the technical assistance.

Contact the technical assistance.
Press the STOP key of the Unit Control,
then press the START key twice to restart
the movement.
If the ERROR persists, contact the technical
assistance.
assistance.
Check the integrity of the UNIT CONTROL
connection cable.
Check connection of the Unit Control with
the Ortomed.
assistance.
Check if the STOP switches were not
enabled. Figures 1 and 2.
Check if the parameter H is correct in the
Unit Control and in the adjustment. Figure 3.
assistance.
assistance.
Check if the parameter H is correct in the
Unit Control and in the adjustment. Figure 3.
Check the ADJUSTMENT OF THE
PARAMETER H, as described in page 28.
assistance.
assistance.
32
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Figures:
Figure 1
Figure 2
Figure 3
Error Table
Error
Code
01
02
03
04
05
06
08
10
20
24
40
Description
Flexion end of course switch enabled
Extension end of course switch enabled
Extension and Flexion end of course switches enabled
Excess current
Excess current + Flexion end of course switch enabled
Excess current + Extension end of course switch enabled
Failure in Encoder
Communication failure between Ortomed and the CPM Unit Control.
STOP switches were enabled Figures 1 and 2.
Excess current + STOP switches were enabled
Error in change of parameter H selected value (figure 3) different from
value H of the Unit Control.
For Technical Assistance: Departamento de Assistncia Tcnica

[Technical Assistance Department]
Rua lvares Fagundes, 359 So Paulo SP Brazil -CEP [zip code]
04338-000
Phone: (0XX11) 5621 7024 / 5622 8205 email: [email protected]
33
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Technical features
Origin:
CARCI Brazil
Model:
ORTOMED 4060
Function and application: Therapy equipment for passive movement
ANVISA [National Health
Surveillance Agency] Registration:
10314290029
UMDNS Code:
11.631
Power supply voltage :
100 to 230 V~ automatic
Supply frequency:
50/60 Hz
Maximum Consumption:
55 VA
Fuse:
2.0 A 250 V ~ 20 AG
Dimensions:
120 x 30 x 42 (cm)
Weight:
15 Kg
----------------------------------------------------------------------------------- Classification according to NBR IEC 60601.1 standards

- Type of protection against electric shock:..................class I
- Level of protection against electric shock of the applied
part:type BF
- Level of protection against harmful water penetration:IPX0
inflammable with air, oxygen or nitrous oxide:not suitable

- Mode of operation:continuous
-----------------------------------------------------------------------------------
Adjustment parameters:
Speeds:
Maximum ( 100% )
Mean ( 60%)
Minimum ( 30%)
Working angles
: For H = 8 from -10 to 120

: For H = 5 from -10 to 115
: For H = 0 from -10 to 110
Equipment environmental operating conditions:
Room temperature
Relative humidity
Atmospheric pressure
: +10C to +40C
: 0% to 80%
: 700 hPa to 1060hPa
Environmental conditions for transport and storage:
Room temperature
Relative humidity
Atmospheric pressure
: -10C to 60C
: 20% to 90%
: 500hPa to 1060hPa
Accessories:
Power cable.
- Methods of disinfection:none, only cleaning. See item on

preventive maintenance
- Level of safety of application in the presence of an anesthetic mixture
ROM ( Range of Motion )
Cable to connect the CPM Unit to Ortomed.

UNIT CONTROL ( CPM Unit 4060 )
Thigh and Leg Support.
Foot Support
Band to fasten the feet.
Ortomed User Manual.
Program Maker Software User Manual.
USB Cable
CD with the Program Maker software
: 70 s 10% (- 10 to 120 )
: 75 s 10% (120 to - 10 )
: 120 s 10% (- 10 to 120 )
: 120 s 10% (120 to - 10 )
: 240 s 10% (- 10 to 120 )
: 250 s 10% (120 to - 10 )
: - 10 ( 2 ) to 120 ( 2 )
34
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ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Symbols
Caution fragile. Handle with care
Equipment symbols
Means equipment off
Keep in a dry place
Means equipment on
This symbol indicates that the equipment causes
physiological effects and that the user must check the
instructions manual before using.
Applied part is type BF
This side up. This symbol indicates the right transport

position
Maximum piling. Indicates the maximum number of boxes
that can be piled. The quantity is marked in the intermediary
square.
Minimum and maximum temperature limits for transport and
storage.
Manufacturer identification
Information on electromagnetic compatibility
Product Manufacturing Date

Product Serial Number
IPX0
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Symbols on the pack
Not protected from harmful water penetration

CE Mark and certifying body identification
This equipment requires special precautions in relation to its

electromagnetic compatibility and must be installed and placed into
operation according to the information provided below.
There are no detachable accessories that affect the ORTOMEDs
compliance with the electromagnetic compatibility standard. All the parts
are fixed in the equipment.
In case of the need for repairs in the equipment, always use the authorized
technical service, since changing the length of cables, elimination or
improper change of some internal suppression components can result in
increased emission or reduced immunity of the ORTOMED.
Terminologies and Definitions:

For purposes of the standard NBR IEC 60601-1:1994 + amendment
1997, the following conditions apply, used in the Manufacturer
Declarations & Orientations :
36
37
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
- Meaning given to the verbal forms should and may
should means that compliance with the requirement or test in
question is mandatory in order to comply with the Standard.
would means that compliance with the requirement or test in
question is strongly recommended, but not mandatory in order to
comply with the Standard.
may means that compliance with the requirement or test in
question is only a particular way of obtaining compliance with the
Standard
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Immunity test
IEC 60601 Test

level
Compliance level
Electrostatic
discharge
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Fast transients /
Bursts
IEC 61000-4-4
2 kV power line
1 kV input line
and signal line
2 kV power line
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV ordinary
mode
<5% Ut
(>95% drop in
Ut)
For 0.5 cycle
1 kV differential
mode
2 kV ordinary mode
Declarations
MANUFACTURER DECLARATION AND INSTRUCTIONS ELECTROMAGNETIC EMISSIONS
ORTOMED is intended for use in the electromagnetic environment described below: The
purchaser or operator of ORTOMED must ensure that it is being used in such
environment.
Emission test
Compliance
Electromagnetic environment orientation
RF Emission
Group 1
ORTOMED uses RF energy for its
CISPR 11
internal operation only. Therefore, its
RF emission is very low and not likely
to cause any interference in another
electronic equipment nearby.
RF Emission
Class A
CISPR 11
Emission of harmonics
Class A
IEC 61000-3-2
Voltage fluctuation /
Compliant
ORTOMED is intended for use in
Emission of flicker
establishments that are not domestic
IEC 61000-3-3
and that are not connected directly to
the public low voltage power network
that supplies buildings with domestic
purposes.
MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC
IMMUNITY
ORTOMED is intended for use in the electromagnetic environment specified below: The
environment.
38
Voltage drops,
short interruptions
and voltage
variations in power
supply.
IEC 61000-4-11
Magnetic fields of
the network
frequencies (50/60
Hz)
IEC 61000-4-8
40% Ut
(60% drop in Ut)
For 5 cycles
Not applicable
<5% Ut
(>95% drop in Ut)
For 0.5% cycle
40Ut
(60% drop in Ut)
For 5 cycles
70% Ut
(30% drop in Ut)
For 25 cycles
70% Ut
(30% drop in Ut)
For 25 cycles
<5% Ut
(>95% drop in
Ut)
For 5 s
3 A/m
<5% Ut
(>95% drop in Ut)
For 5 s
3 A/m
Electromagnetic
environment orientation
The floor can be of
wood, concrete or
ceramic. If the floor is
covered with
synthetic material, the
airs relative humidity
should be at least
30%.
The quality of the

power network must
be that of a typical
hospital or
commercial
environment.
The magnetic fields of

the network
frequencies must be
levels characteristic
of a typical
39
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
commercial or
hospital environment.
Note: Ut is the A.C network voltage before application of the test level.
MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC
IMMUNITY
ORTOMED is intended for use in the electromagnetic environment specified below: The
environment.
Immunity test
IEC 60601
Compliance
Electromagnetic
Test
level
environment - orientation
Level
Portable and mobile RF
communication equipment
should not be used closer to
any ORTOMED part,
including cables, more than
the separation distance
recommended calculated by
the equation, applicable for
the transmitter frequency.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3V
Irradiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to 800
MHz
GHz
800 MHz to 2.5
Where P is the maximum

output power of the
transmitter in watts (W),
according to the transmitter
manufacturer, and d is the
recommended separation
distance in meters (m).
The field generated by fixed
RF transmitters, as
40
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
determined by an
electromagnetic field in the
a
location , must be less than
the level of compliance in
b
each frequency range.
There can be interference
around equipment with the
following symbol:
NOTE 1: the greatest frequency in the range is applied in the range of 80 MHz and 800
MHz.
NOTE 2: this procedure may not apply in all cases. Electromagnetic propagation is
affected by absorption and reflection of structures, objects and people.
a. The intensity of fields generated by fixed transmitters, such as cell sites for telephones
(cell/wireless) and land mobile radios, amateur radios, AM, FM and TV radio diffusion
stations may not be theoretically prognosed accurately. To evaluate the electromagnetic
environment due to the fixed RF transmitters
, in a study of the electromagnetic field in the location must be considered. If the field
intensity measured at the site in which the ORTOMED is used exceeds the compliance
level above, the ORTOMED must be observed to ascertain if it is working properly. If
abnormal performance is noticed, additional measures may be required, such as
reorientation or relocation of the ORTOMED;
b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity must be less than
3 V/m.
Recommended separation distances between portable and mobile RF
communication equipment and the ORTOMED
The ORTOMED is intended for use in an electromagnetic environment in which the RF
disturbances are controlled. The purchaser or operator of the ORTOMED can help
prevent electromagnetic interference by keeping a minimum distance between portable
and mobile RF communication equipment (transmitters) and the ORTOMED, as
recommended below, according to the maximum output potential of the communication
equipment.
Declared maximum
Separation distance according to the transmitter frequency
output potential of the
transmitter (W)
150 kHz to 80 MHz
80 MHz to 800 MHz
800
MHz to
2.5
41
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
GHz
0.01
11.70 cm
11.70 cm
0.1
37.00 cm
37.00 cm
1.17 m
1.17 m
23.00
cm
72.70
cm
2.30
m
10
3.70 m
3.70 m
7.27
m
100
11.70 m
11.70 m
23.00
m
For transmitters with declared maximum output power not listed above, the
recommended separation distance (d in meters) can be determined using the
equation applicable to the transmitter frequency; where P is the maximum
output power of the transmitter in watts (W), according to its manufacturer.
NOTE 1: the 80 MHz and 800 MHz apply to the separation distance for the
highest frequency.
NOTE 2: this procedure may apply in all cases. Electromagnetic propagation is
affected by absorption and reflection of structures, objects and people.
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
Manufacturer Data:
CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CGC [Corporate Taxpayers Roll]: 61.461.034/0001-78
State Tax ID: 110.182.450.113
Rua lvares Fagundes, 359 So Paulo SP Brazil
CEP [zip code] 04338-000
Phone: (0XX11) 3346 2100
email: [email protected]
website: www.carci.com.br
Carci Registration in the Ministry of Health: MS-1.03.142-9
For Technical Assistance:
Technical Assistance Department
Rua lvares Fagundes, 359 So Paulo SP Brazil
Phone: (0XX11) 5621 7024 / 5622 8205
Technical Responsible:
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D
Final considerations
It has been Carcis policy to continuously improve the quality of its products.
Carci reserves the right to make modifications in the design and
specifications, and to also add to and improve its products, without the
obligation to install them in already manufactured products.
The text, illustrations and specifications contained in this manual are based
on information available during the printing.
All rights reserved.
This manual may not be reproduced in whole or in part without written
consent from Carci.
OBELIS SA
34, Av. de Tervuren,
bte 44
B 1040 Brussels ,
BELGIUM
Phone: (32) 2.732.59.54
Fax: (32) 2.732.60.03
email: [email protected]
WARRANTY CERTIFICATE IN ANNEX
42
43
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
References:
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44
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
16. Zeichen J, van Griensven M, Bosch U 2000 The proliferative response of
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45
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
29. Pneumaticos SG, Phd PCN, McGarvey WC, Mody DR, Trevino SG 2000 The
effects of early mobilization in the healing of achilles tendon repair. Foot Ankle Int
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46
47
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
59. Finsterbush A, Frankl U, Mann G 1989 Fat pad adhesion to partially torn anterior
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motion on the clearance of haemarthrosis. Clinical Orthopaedics and Related
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77. Salter R B, Bell R S, Keeley F W 1981 The protective effect of continuous
passive motion on living articular cartilage in acute septic arthritis: an experimental
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86. Salter R B, Simmonds D F, Malcolm B W, Rumble E J, MacMichael D, Clements
N D 1980 The biological effect of continuous passive motion on the healing of full-
48
49
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
ORTOMED 4060
Knee CPM Unit
_______________________________________________________
thickness defects in articular cartilage. Journal of Bone and Joint Surgery

62(A)(8):1232-1251.
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70
97. Sadoshima J-I, Seigo I 1993 Mechanical stretch rapidly activates multiple signal
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75(11):1636-47.
50
51

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Ortomed

Accessories that come with the device

Read, understand and practice the precaution and operation

Installing / Connecting to the power network

Replace the fuse box in the Ortomed.

4. Press and keep the key pressed

6. Followed by the screen

7. Release the key

9. Press the key

11. Select the desired H, and proceed according to the instructions of

12. Or turn off the Ortomed

CHK.: XXXX Software Registration

Displays the ROM (Range Of Motion) selected for the cursor.

Displays the values selected for Extension and Flexion.

Informs that the cursor is in direction of Extension = 0

Measure the patient

This measurement is called Height H.

Through the handle, fix the adjustment of the height H selected.

4. Changing to the screen:

5. Use the keys

8. Use in Manual Mode:

The manual mode allows selecting the direction (extension or

Position the cursor in Extension = 30 and press the

The support will move up to Flexion angle = 90

In case there is need to increase or reduce the angles of

9. Use in Continuous Mode

The Continuous mode allows selecting the speed and Extension

To move the support up to Flexion = 90, position the cursor in

Flexion = 90 and press the

Procedure for continuous use:

9.4. After the support is positioned in the Flexion position = 10,

There being the need to stop movement, press the

To restart movement, press the

key. The support

10.2. Through the

key10.3. Press the

keys, select the program desired.

key again. The support will restart the

10. Use in Program Mode

10.4. To start movement, press the

NOTE: In case of discomfort to the patient, press the

After exiting the selected program, the Ortomed can be

Step = 5 Program 2: Total Arthroplasty

Evolves from 5 to 5, with the programmed pauses

The Ortomed will enter the boot screen.

keys at the same time, the parameter H will

keys at the same time to return to the

key again to start the movement again.

keys and the parameter H is not

prescribed above, must be conducted by authorized technical

The Ortomed cannot be turned on

once a year by the factory or authorized technical service.

The Ortomed displays the main

The Ortomed displays ERROR 01 or 02

Check if the power cable is connected to the

The Ortomed displays ERROR 04

The Ortomed displays ERROR 08

The Ortomed displays ERROR 10

The Ortomed displays ERROR 20