Zimmer OptonPro User manual

Instructions for Use
OptonPro
GB

Illustrations
Front of the device
Fig. 1
Selection and control elements 1Controller
2Display
3Emergency stop button
4 Slot for SD card
5On/off switch
Applicator with optical fibre 6Applicator
7Fibre-optic cable
Test sensor 8Test sensor and bracket for applicator
1
2
3 4 5
8
6
7

Illustrations
Rear of the device
Fig. 2
Connection sockets
9 Connection socket for foot switch
10 Connection socket for interlock socket
11 Connection for power cord
12 Holder for power fuse
13 Identification plate
14/15 Socket without function for OptonPro
16 Fibre-optic output
9 10 11 12 13 14/15
16

Illustrations
Display / Navigation bar
Fig. 3
Display
9Status bar 10 Button on the screen
11 Title bar
12 Navigation bar
Fig. 4
Navigation bar
Description of the
functions
(A) Start Moves back to the start page
(B) Back Takes you back one step
(C) Key Activates key input
(D) Performance test Switches to the calibration page
(E) Memory Switches to the memory area
(F) Indications Switches to the indication menu
(G) Programs Switches to the programme list
(H) Favourites Switches to the favourites area
(I) Scroll backwards Moves back one page
(J) Scroll forward Moves one page forward
10
12
11
9
A
B
C
D
E
F
G
H
J
I

Illustrations
Accessories
22 Small spacer 23 Large spacer 24 Foot switch
25 Laser warning sign with
laser warning lamp
26 Interlock plug 27 Protective sleeve
28 Laser protection glasses 29 Laser warning sign

Explanation of symbols
Caution laser outlet Note: Laser radiation is emitted from applicator tip
Turn the emergency stop button clockwise (following the arrows) to unlock
Application part type BF
Foot switch socket
Interlock socket
Value of accessible fuses
Protection class II
Instructions for use
Follow instructions for Use
Serial number
Article number
Manufacturer
Date of manufacture
Caution ! In the instructions for use this symbol indicates „Caution“ with regard to
possible damage of the device.
In the instructions for use this symbol indicates “Danger / Warning”.

Contents
Illustrations
Front of the device
Rear of the device
Display / Navigation bars
Accessories
Explanation of symbols
Page
1Indications 1
2 Contraindications 2
3
Side effects 3
4
Safety instructions/warnings 4
5
Application information 6
6
OptonPro – in brief 9
7
Device set-up
7.1 Safety precautions
7.2 Assembly and commissioning
10
11
8
Settings 12
9
Operating instructions
9.1 Performing the treatment
9.2 Key code
9.3 Thermal threshold test
9.4 Two-phase programs
9.5 Storing programs
9.6 Favourites/memory list, retrieving programs, editing lists
9.7 Treatment recommendations
15
22
23
25
26
28
30

Contents
10
Performance test 32
11
Key code 33
12
Technical data 34
13
Cleaning/disinfection 36
14
CE mark 38
15
Scope of delivery/accessories 39
16
Device combinations 40
17
Safety and maintenance 41
18
Functional test 42
19
Safety checks
Metrological control 43
20
Error messages/troubleshooting/disposal 44
21
Manufacturer´s EMC declaration 46
Valide for OptonPro devices.
This instructions for use is an integral part of the device. It must be stored with the device and kept accessible at all times for
anyone authorized to operate this device.
The instructions for use is valid as of March 2015.

Indications 1
Page 1
OptonPro is used to initiate and support the healing of human tissues. The
device is suitable for treating the following indications:
Myopathy, tendinopathy
Lower back pain (e.g. ischialgia)
Arthropathy, arthrosis
Rheumatoid arthritis
Trauma disorders (e.g. distortion, strain)
Impingement syndroms (e.g. carpal tunnel syndrome)
Skin diseases (e.g. acne vulgaris, herpes simplex, verrucas, ano-genital
warts, leg ulcers, and decubitus ulcers)
The following effects have been demonstrated:
Musculoskeletal disorders
Healing, pain relief
Rheumatoid arthritis
Alleviation, pain relief, increased mobility
Carpal tunnel syndrome
Pain relief
Tendinopathy
Alleviation, pain relief, increased mobility
Epicondylitis
Healing
Back and neck pain
Pain relief
Chronic joint diseases
Pain relief
Practical experience has also shown that the device can have a positive effect
in treating the following diseases:
- Periarthropathia humeroscapularis
- Adductor insertion tendinopathy
- Patellar tendinitis
- Major trochanteric tendinopathy
- Achillodynia
- Plantar fasciitis
- Insertion tendinopathy of the pes anserinus
- Painful muscular tension
- Gonarthrosis
- Rhizarthrosis
- Cervical spondylarthrosis
- Torn muscles
- Morton’s neuroma

Contraindications 2
Page 2
- Fresh haematomas
- Malignant, semi-malignant, and benign tumours
- Treatments around the eye
- Pregnancy
- During menstruation in the abdomen or lower back
Particular caution is advised when applying treatment near the ear, nose,
mucous membranes, and blood vessels. Avoid direct irradiation of these areas.
In the presence of skin diseases, metabolic diseases, and inflammatory
diseases, a physician should be consulted prior to treatment.

Side effects 3
Page 3
When used correctly, no side effects are known.

Safety instructions/warnings 4
Page 4
The OptonPro is a class 4 laser. The laser radiation is extremely hazardous to
the eyes and skin. Even diffusely scattered radiation can be dangerous. Laser
radiation can cause fires or explosions.
The laser radiation emitted by the device is invisible.
Caution: the use of controls or settings options in a manner other than those
described here may lead to hazardous exposure to radiation!
Please observe all relevant safety instructions!
The device must only be operated in accordance with occupational safety
regulations and the rules of the relevant professional associations. The
corresponding directives and regulations must be observed.
The device may only be operated via a properly earthed socket with a
grounded outlet (in accordance with VDE 0100 Part 710).
The device may only be operated in accordance with these instructions. All
other applications shall be the responsibility of the operator.
For maintenance, extensions, readjustments, or changes, please refer to the
national regulations.
If there is any visible damage to the unit, the optical fibre, or applicator, the
device must not be operated. Call customer service.
Legal requirements in
accordance with the
regulations of the
BGV B2 (German
Occupational Health
and Safety Regulations
of the trade
associations, applies
only within Germany)
1. Before first use, the commissioning of the device must be reported to the
professional association and the competent authority for occupational
safety (such as the trade supervision board).
2. The operator must appoint a laser safety officer.
3. The laser safety officer must provide safety instruction to all persons
involved in the use of the device. This training must be repeated annually.
4. The device may only be operated by trained personnel who are at least 18
years of age. All persons working within the area of the laser must be
briefed on the rules of conduct and safety.
5. The area in which the laser is to be used must be identified with laser
warning signage (e.g. on all doors to the treatment area). There must be
warning lights on the doors that indicate when a laser is in use.
6. All doors to the laser treatment area should be secured with an interlock
device. Other measures to protect against accidental irradiation are also
allowed.
7. All objects and substances in the laser treatment area must be flame
retardant.
8. Any instruments used in the laser treatment area must be designed in
such a way as to prevent hazardous reflections.
This information has been taken from the BGV B2 and was valid at the time these operating instructions were printed.
They are subject to change without notice.

Safety instructions/warnings 4
Page 5
General 1. The device is not intended for use in potentially explosive and/or
combustive environments.
2. The use of flammable anaesthetic gases or oxidising gases such as
nitrous oxide (N2O) or oxygen should be avoided. Some materials such as
cotton, which are saturated with oxygen, can be ignited by the high
temperatures that arise when the laser device is used. Adhesive solvents
and flammable solutions used for cleaning and disinfection must be
allowed to evaporate before the laser device is used. Attention should be
paid to bodily gases, which may also ignite.
3. To avoid skin damage, please follow the treatment guidelines in the laser
manual.
4. Please note that reflective objects in the treatment area can diffract the
laser radiation.
5. Ensure that the laser treatment area is free of flammable substances.
6. Please note that the laser radiation can exit the treatment area via
windows, glass doors, or other openings. Please take the appropriate
precautions.
7. The fibre-optic cable and applicator are highly sensitive optical systems.
Treat them with the appropriate care, and protect them from
contamination.
8. Never bend the fibre-optic cable, and protect it against tensile loads.
Damage to the fibre-optic cable can lead to unwanted exposure to
radiation.
9. Under no circumstances should you unscrew the spacer sleeve on the
front part of the applicator. A treatment without the spacer sleeve or with
an incorrectly installed sleeve can lead to increased exposure to the laser
beam and may cause skin burns.
10. When in use, electrical devices emit electromagnetic fields that may
interfere with other devices. If in doubt, maintain sufficient distance from
potential sources of interference, or avoid operating such devices
simultaneously.
11. The device should only be used in the case of indication by a physician.
12. Caution – If operating/adjusting devices other than those described here
are used or if other procedures are performed, these may result in
hazardous radiation effects.

Application information 5
Page 6
Prior to using the device on the patient, the user should familiarize himself with
the operating instructions and the individual treatment methods to be used, as
well as with the indications, contraindications, warnings, and application
information. Additional sources of information about the treatment should also
be considered.
Caution!Before use, ensure that the device is operated via a properly grounded socket
(electrical installation in accordance with DIN VDE 0100 Part 710). The device
must only be operated with the power cable supplied. The power cable must be
protected against mechanical stress.
Caution!Operating this device in the vicinity of strong electromagnetic fields (e.g.
tomographs, x-ray or diathermy equipment) may interfere with the operation of
the device. Please keep a safe distance of several meters.
OptonPro should not be used in an explosive, flammable or combustive
environment.
When in use, the device must be located in a position that allows direct access
to the central power supply so that it can be disconnected at any time.
To avoid the risk of electric shock, the plug must be disconnected from the
power supply before performing any cleaning or maintenance activities.
Inspect the device before use. If there is any damage, the device must not be
used.
Caution!Only accessories from Zimmer MedizinSysteme GmbH may be used.
Through electromagnetic effects, the device may cause malfunctions or
interfere with the operation of other equipment in the surrounding area. It may
be necessary to take appropriate remedial action, such as realigning or
reassembling the device, or installing electromagnetic shielding.
Caution!The device may only be opened by authorised service technicians from Zimmer
MedizinSysteme.

Application information 5
Page 7
Applicator The applicator is located at the end of the fibre-optic cable. Laser beam is
emitted from the tip of the applicator. A lens protects the opening of the outlet
against dirt and damage.
Only aim the applicator at the area to be treated. Never place it down outside
of the test sensor.
Foot switch The foot switch is used to initiate the laser beam. Only press the foot switch
once the applicator has been aimed at the area to be treated. An acoustic
signal sounds while the laser beam is being emitted. Position the foot switch in
such a way that it cannot be activated accidentally or by unauthorised persons.
Emergency stop
button The emergency stop button enables an immediate interruption of operation by disconnecting the power supply.
To interrupt operation, press the emergency stop button until it clicks and the
device shuts down.
To resume operation, return the button to its original position by turning the red
knob in the direction of the arrows.
Test sensor The test sensor enables the measurement and adjustment of the laser power.
The applicator can be placed on the test sensor after treatment and when not
in use. The applicator is protected against dirt and damage.
Saftey glasses All individuals present in the treatment room (e.g. patient, therapist, and
support staff) should wear the appropriate protective goggles.
Only use goggles with an optical density OD > 3 at 810/980 nm and a
translucence of at least 20% in the visible range. The goggles must be both
heat- and UV-resistant and comply with the requirements of EN 207.
Spacers There are two spacers available, each with a different length and treatment
surface. These hold the laser head at a defined distance from the skin.
Note that it may particularly lead to high power densities in the use of the
handpiece without spacers and set high power power. There is a risk of
thermal damage to the skin. Using the device without spacers is not
recommended.
Protective sleeves Protective sleeves are available when the device is used without the spacers.
They can be placed on the applicator to enhance patient comfort.
Silicone spacer
(optional) For the treatment of skin diseases, optional spacers made of silicone are available; these must be placed on the applicator to avoid contamination.
Note: For additional instructions on the use, cleaning, and disinfection of the spacer,
please refer to the operating instructions.

Application information 5
Page 8
SD card Custom settings and treatment recommendations are saved on the SD card.
Treatment
recommendations If no SD card is inserted, the “Treatment recommendations” button is not shown in the navigation bar.
Favourites If no SD card is inserted and the favourites area is activated, the following message
will appear:
“SD card was not found”. Insert the SD card, and confirm with “OK”.
Memory If no SD card is inserted and the memory area is activated, the following message
appears:
“SD card was not found. The use of the memory requires an SD card”.
Insert the SD card, and confirm with “OK”.

OptonPro – in brief 6
Page 9
What is OptonPro? A high-power medical laser treatment device for treatment with laser radiation.
What does OptonPro
do? It emits laser beams to provide photochemical and thermal stimulation of those
parts of the musculoskeletal system requiring physical treatment.
Why use OptonPro? The simultaneous use of laser beams of two wavelengths (810 and 980 nm)
provides the user with a wide array of treatment options.
The modern microprocessor control system and the precise equipment for
measuring power facilitate the use of the device and minimise risks.
The modern, clearly understandable colour display shows all parameters
relative to the treatment, and the modern touch-screen controls facilitate
treatment.
Individual start-up settings as well as clear and simple menu navigation
provide the user with the maximal comfort.
Note: The device may only be used by healthcare professionals (e.g. physicians,
therapists, and trained medical assistants).

Device set-up
7.1 Safety precautions 7
Page 10
Safety measures Place a laser warning sign and a warning light on each door to the treatment
room.
The laser safety officer must ensure that all safety measures have been
correctly followed.
When not in use, the device should be protected against activation of the key
button by unauthorised users.
Note: Make sure that the main switchof the device is set to “0”.
Ensure that all individuals in the treatment room are wearing safety goggles.
Make sure that the applicator (6) is fully inserted into the calibration sensor (8).

Device set-up
7.2 Assembly and commissioning 7
Page 11
Assembling the
power cable Connect the power cable to the corresponding socket (11) on the device, and connect the cable to the mains.
Interlock connector Connect the interlock plug (27) to the corresponding socket on the device (10).
Connect the foot
switch Connect the foot switch (27) to the corresponding socket on the device (10) and place it on the floor.
Attach spacer Insert the spacer (23/24) onto the applicator.
Switch on the device Turn on the device at the main switch.
Select programme Press the “Start” button, and select a program.
Activate key code Select the “Key” button, and enter the key code 1234.
Setting the beam
intensity Set the desired intensity.
Activate the laser Activate the laser by pressing the “Start” button.
Applicator Place the applicator in the correct position on the area to be treated.
Start of treatment The treatment starts once the foot switch has been activated.
End of treatment By de-activating the foot switch, the treatment is interrupted or terminated.
After treatment, remove the spacer from the applicator, and insert this into the
test sensor.

Settings
8
Page 12
Note: The following descriptions are based on the factory default settings.
All buttons, menus, and sub-menus can be activated directly on the screen by
finger pressure.
Ensure that all individuals in the treatment room are wearing safety goggles.
To prevent unauthorised persons from using the laser, the OptonPro must be
activated by entering a key code each time it is switched on and off.
Only once the code has been entered can the laser beam power be adjusted
and emitted.
Changes to the default settings are only possible from the start-up screen.
Start-up screen
Selecting the
configuration Activating the “Settings” button (1) opens the “Settings” screen.
Settings
In the settings menue, the factory default settings can be individually changed and adjusted.
After activating the Settings, the “Settings” screen is active.
1
2