Zimmer OptonPro User manual

Instructions for Use
OptonPro
25 Watt, 15 Watt, 10 Watt
EN

Illustrations
Front of the device
Fig. 1
Selection and operating
elements
1 Control unit
2 Display
3 Emergency stop button
4 On/off switch
Applicator with light guide
5 Applicator with
5.1 Manual switch and
5.2 Integrated infrared sensor and laser aperture
6 Optical fibre
Test sensor
7 Test sensor and holder for applicator
1
2
3
4
5
6
7
5.1
5.2

Illustrations
Rear of the device
Fig. 2
Ports
8 Light guide outlet
9 Connection port for foot switch
10 Identification plate
11 Connection for power cable
12 Holder for mains fuse
13 Connection port for interlock plug
14 Connection port for USB
8 9 10 11 12 13 14

Illustrations
Screens / display
Fig. 3
Display view
1 Status line
2 Buttons on the screen
3 Buttons in the navigation menu
4 Buttons in the status bar
Fig. 4
Navigation menu /
status bar
Description of the
functions
(A) Therapy
Switches to the therapy screen
(B) History
Switches to the VAS history
(C) Favourites
Switches to Favourites
(D) Assistant
Switches to Assistant
(E) Protocols
Switches to Protocols
(F) Back
Switches one page back or to the
start-up screen
(G) Save
Switches to Memory
(H) Performance test
Switches to the performance test level
(I) Information
Switches back to therapy recommendations
2
3
4
1
A
B
C
D
E
F
G
H
I

Illustrations
Accessories
1 Spacer, small
2 Spacer, large
3 Foot switch (optional)
4 Laser warning sign with laser
warning light
5 Interlock plug
6 Protective laser glasses
7 Laser warning sign
OptonPro 10 W
8 Laser warning sign
OptonPro up to max. 25 W

Explanation of symbols
Caution: laser aperture
Note: The laser beam exits at the end of the applicator
Turn the emergency stop button in the direction of the arrow to unlock
Applied part type B
Connection port for foot switch
Connection port for interlock
Rating of the accessible fuses
Protection class II
Instructions for use
Follow instructions for use.
Serial number
Catalogue 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.
Labelling the beam aperture
USB connection port
Optical fibre
Disposal of electrical and electronic equipment as well as used batteries and accumulators.
Products marked with the adjacent symbol must not be disposed of with household waste.

Contents
Figure
Front of the device
Rear of the device/switches and ports
Display views/navigation menus
Accessories
Explanation of symbols
Page
1
Indications 1
2
Contraindications / Side effects 2
3
Safety information / warnings 3
4
Application information 7
5
OptonPro – in brief 7
6
System set-up
6.1 Safety measures
6.2 Assembly and start-up
10
11
7
Configuration 12
8
Operation instructions
8.1 Performing a treatment
8.2 Displays and buttons
8.3 Protocols
8.4 Assistant
8.5 Thermal threshold test
8.6 Favourites
15
16
20
21
23
25
9
Technical information 26
10
Cleaning / disinfection
28

Contents
11
CE mark / manufacturer 29
12
Scope of delivery, accessories 30
13
Device combinations / Safety and maintenance /
Functional test
31
14
Safety check
Metrological check
32
15
Error messages / troubleshooting / disposal 33
16
Manufacturer's EMC declaration
34
Valid for the device OptonPro.
These instructions for use are an integral part of the device.
They must be stored with the device and kept accessible at all times for anyone authorised to operate this device.
Last updated: July 2019

Indications
1
Page 1
The following indications can be mentioned in particular:
Lateral epicondylitis
Chronic neck pain
Osteoarthritis of the knee
Subacromial impingement syndrome
Pain in the lower back
The following effects are demonstrably achieved:
Lateral epicondylitis
Healing
Chronic neck pain
Pain relief, mobility
Osteoarthritis of the knee
Pain relief, mobility
Subacromial impingement syndrome
Healing, pain relief, mobility
Pain in the lower back region
Pain relief
Experiences from clinical practice have also shown that a positive effect can be achieved when treating the following
conditions:
Treatment recommendations:
•Humeroscapular periarthritis (”frozen shoulder”)
•Insertional tendinopathy of the adductors
•Patellar tendonitis
•Tendinopathy of the greater trochanter
•Achillodynia
•Plantar fasciitis
•Insertional tendinopathy of the pes anserinus
•Painful muscle tension
•Osteoarthritis of the knee
•Osteoarthritis of the base of the thumb
•Spondylarthrosis, cervical
•Muscle tear
•Morton’s neuralgia
•Sprain, strain
•Carpal tunnel syndrome
•Tendinopathy
•Myopathy
•Acne vulgaris
•Herpes labialis
•Plantar warts
•Anogenital warts
•Venous leg ulcer
•Decubitus ulcer
•Idiopathic facial nerve palsy
•Fibromyalgia

Contraindications / Side effects
2
Page 2
Contraindications
•Fresh haematoma
•Malignant, semi-malignant and benign tumours
•Treatments in the area surrounding the eye
•Pregnancy
•In the region of the abdomen and lower back during menstruation
Particular caution is required when administering treatment near the ear, nose, mucous
membranes and blood vessels. Direct radiation must be avoided.
If there are skin diseases, metabolic diseases or inflammatory diseases, a physician should
be consulted prior to treatment.
Side effects
No side effects are known if used correctly.

Safety information / Warnings
3
Page 3
OptonPro is a class 4 laser. The accessible laser beam is very dangerous to the eye and
dangerous to the skin. Even diffusely scattered radiation can be hazardous. The laser beam
can cause a risk of fire or explosion.
The laser beam emitted from the device is invisible.
Observe all corresponding safety instructions!
Operation of the device is subject to occupational safety regulations and the regulations of
professional associations. Corresponding guidelines and regulations must be observed.
The device may be operated only at a properly connected socket with protective conductor
(according to VDE 0100 part 710).
The device may only be operated in accordance with these instructions for use. All other
applications are the responsibility of the operator.
For maintenance measures, expansions, readjustments or modifications, the provisions of
the German Medical Devices Act and the Medical Device Operator Ordinance apply.
If there is visible damage to the device, the light guide or applicator, the device should not be
used any further. Call customer service.
Legal regulations
according to the
Occupational Safety
and Health Ordinance
on Artificial Optical
Radiation (OStrV)
(only for the Federal
Republic of Germany)
1. The operator must conduct a hazard assessment and display operating instructions.
2. The operator must designate a laser protection officer.
3. The laser protection officer must provide safety-related instruction to persons assigned
to use the device. This instruction must be repeated annually.
4. The device may be operated only by trained persons (minimum age 18 years). All
persons in the working area of the laser must be trained in the rules of conduct and
safety instructions to be observed.
5. The operational area of the laser must be identified with the laser warning sign (for
example, on all doors of the treatment room). Warning lights on the doors must indicate
the operation of the laser.
6. All doors to the operational area (e.g., treatment room) of the laser should be secured
with an interlock device. Other measures to protect against inadvertent radiation are
permitted.
7. All objects and materials located in the working area of the laser must have low
flammability.
8. Instruments used in the working area of the laser must, through their shape and
material, exclude hazardous reflections.
This information is taken from the Occupational Safety and Health Ordinance on Artificial Optical Radiation – OStrV
– and are valid at the time of printing. They may be changed at any time without notice.

Safety information / Warnings
3
Page 4
General
1. The use of flammable anaesthetic gases or oxidising gases such as nitrogen oxide
(N2O) and oxygen should be avoided. Some materials, such as cotton, which are
saturated with oxygen, can ignite in the case of high temperatures which develop when
the laser device is used as intended. Solvents of adhesives and flammable solutions
which are used for cleaning and disinfection should be given time to evaporate before
the laser device is used. Attention should also be paid to the fact that gases produced
by the body itself can ignite.
2. To avoid skin damage, please observe the therapy guidelines in these instructions for
use.
3. Be aware that reflective objects in the treatment area can deflect the laser beam.
4. Ensure that the working area of the laser is free of flammable materials.
5. Be aware that the laser beam can leave the treatment room through windows, glass
doors or other openings. Take corresponding precautionary measures.
6. The light guide and the applicator are very sensitive optical systems. Accordingly, treat
them with care and protect them from soiling.
7. Never bend the light guide and protect it from tensile stress. Damage to the light guide
can lead to undesired beam exposure.
8. Never unscrew the spacer sleeve on the front part of the handpiece. Treatment without
the spacer sleeve or with an incorrectly mounted sleeve can lead to increased beam
exposure or to burns of the skin.
9. Operation of 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.
10. To avoid the risk of electric shock, the plug must be disconnected from the power
supply before performing any cleaning or maintenance activities.
11. Inspect the device before use. If there is any damage, it must not be used.
12. Only accessories provided by Zimmer MedizinSysteme GmbH must be used.

Safety information / Warnings
3
Page 5
General
User group
The use of the OptonPro is limited to professionals (such as physicians, therapists and
healthcare professionals).
Patient groups
No limitation with regard to gender, nationality, ethics and skin colour types I Celtic type, II
Nordic type, III mixed type, IV Mediterranean type, V dark type, VI black type.
Age: The person to be treated must be able to clearly communicate pain perception; small
children and babies in the growth phase are excluded.
General: The person to be treated must have intact thermal perception.
Information for the user
The users of the OptonPro must have read the user manual prior to the first use of the
device, including the treatment methods, indications, contraindications, warnings and
application information.
Observation of and feedback from the patient
During the therapy, the patient may not be left unattended. The user must take note of the
patient’s feedback and react accordingly.
Following treatment instructions
Treatment instructions regarding location, duration and scope of the treatment require
medical knowledge and may only be given by authorised physicians, therapists and medical
professionals. These instructions are mandatory.
Usage environment
Application may take place only in closed, dust-free rooms.
Use in wet areas is not permitted and may in case of non-compliance lead to considerable
damage and endanger both the patient and the user.
Application outside of/according to use as intended
The use of the device outside of the settings or applications indicated in the instructions for
use can lead to hazards which lead to the uncontrolled release of laser energy. The device
may be used only according to its intended use.

Safety information / Warnings
3
Page 6
General
Pilot beam takes the same path as the therapy beam
Since the pilot beam takes the same path as the therapy beam, this is a good way to check
the integrity of the laser transmission system. If the pilot beam does not appear at the distal
end of the applicator, if its intensity is low or if it appears to be scattered, this is a possible
indication of a damaged or defective laser transmission system.
Risk of explosion and combustion
If the laser outlet is used near flammable materials, solutions or gases or in an oxygen-
enriched atmosphere, there is a risk of fire or explosions.
No maintenance during the laser therapy
No maintenance work may be performed during the laser therapy.
No reflective and scattering objects
The user and the patient may not wear any reflective and scattering objects in the treatment
field, for example, rings, piercings, etc.
No changes during the service life
During the service life of the device, no changes may be made to the device or the medical
system.
No therapy if pain relievers or mind-altering substances are taken
Since taking these substances can lead to a change in pain perception, no therapy should be
performed. In the worst case, this can lead to burns.
Use of protective glasses
All persons in the treatment room must wear protective laser glasses. Use only protective
glasses with an optical density OD > 3 (protection level at least LB 3) at 810/980/1064 nm for
operating mode D (continuous wave) and a light transmission of at least 20% in the visible
range. The glasses must be both heat- and UV-resistant and meet the requirements of EN
207. The protective glasses must be designed for power up to 25 W.
No connections of devices with their own power supply
No devices with their own mains power (e.g., plug-in power supply) may be connected to the
USB interface and to the connection for the interlock/foot switch.
No use in connection with a high-frequency surgical device
A simultaneous connection of the patient with a high-frequency surgical device is not
permitted. This can lead to burns.

Application information
4
Page 7
Caution
!
Prior to using the device on a patient, the user should become familiar with the instructions for
use and individual treatment methods to be used as well as the indications/contraindications,
warnings and application information. Additional sources of information about the treatment
should also be followed.
Caution
!
The device must only be operated with the supplied power cable. The power cable must be
protected against mechanical stress.
Caution
!
During use, the device is to be located in a position allowing direct access to the device´s
central mains supply so that it can be disconnected from the mains at any time. To do this, pull
the mains plug out of the socket.
Caution
!
The device may be opened only by service technicians authorised by Zimmer MedizinSysteme
GmbH. The device does not contain any parts to be maintained by the user.
Caution
!
When using silicone spacers (spacers for wound treatment), the corresponding instructions for
use must be read.
Caution
!
The complete medical system is suitable for use in the vicinity of the patient.
Caution
!
Contact components (spacers, applicator) must be cleaned and disinfected after each use.
Caution
!
To ensure that the persons responsible have access to the instructions for use at all times,
these instructions should always be stored with the device.
Caution
!
Handle the optical fibre carefully and do not expose it to any strong tensile, pressure or bending
stress. The optical fibre can be damaged if it is bent excessively. To prevent this, the bending
radius should never be less than a minimum of 60 mm.
Caution
!
The laser light can be activated and deactivated using the foot switch or the manual switch on
the applicator. The mechanism activated first is always the one applied.
Caution
!
High-power laser applications lead to intense heating of the laser unit, for technical reasons.
When applying very large amounts of high-power energy (>4,000 Joule), a cooling phase is
automatically initiated by the device during which no laser radiation is emitted.
This is shown by the message “Excessive temperature. The laser is being brought to operating
temperature. Ready to use again in XX:XX min:sec.” (see chapter 15).

Application information
4
Page 8
Applicator
The applicator is at the end of the light guide. The laser beam exits from the front end of the
applicator. The aperture is protected by a lens from dirt and damage.
Direct the applicator only on the area of the patient to be treated. Never lay it down outside of
the test sensor.
Manual switch
The manual switch is used to trigger the laser beam. Operate the manual switch only when
you have directed the applicator beforehand at the patient’s body area to be treated. An
acoustic signal can be heard while the laser beam is being emitted.
Emergency stop button
The emergency stop button makes it possible to immediately interrupt operation of the device
by interrupting the power supply.
To interrupt operation, press the emergency stop button until it clicks into place and the
device switches off.
To resume operation, return the button to the original position by turning the red button in the
direction of the arrow.
Test sensor
The test sensor makes it possible to measure and balance the laser power emitted.
The test sensor is also used to store the applicator after the treatment and during periods in
which the device is not in use. In this way, the applicator is protected from dirt and damage.
Protective glasses
All persons present in the treatment room (patient, therapist, assistant personnel) must wear
suitable protective glasses.
Use only protective glasses with an optical density OD > 3 at 810 nm and 980 nm and a light
transmission of at least 20% in the visible range. The glasses must be heat- and UV-resistant
and meet the specifications of EN 207. The protective glasses must be designed for power
up to 25 W.
Spacers
Two spacers with different lengths and therapy areas are available which hold the laser head
at a defined distance from the skin. Be aware that there may be high power densities,
particularly when the handpiece is used without a spacer and when the output power is set to
a high level. There is a risk of thermal skin damage. Use without a spacer is not
recommended.
Spacers, silicone (optional)
Spacers made of silicone are optionally available for the treatment of skin diseases; these
spacers must be placed on the applicator to avoid contamination.
Note:
Additional information regarding use, cleaning and disinfection can be found in the
instructions for use of the silicone spacer for wound treatment.

OptonPro – in brief
5
Page 9
Intended use of
OptonPro
OptonPro is a medical therapy device for the generation of a laser beam from three
wavelengths for the thermal initiation and support of tissue healing processes for external
application. The application is contact-free.
What are the benefits of
OptonPro?
The simultaneous application of laser light from two – depending on the model – or three
wavelengths (810/980 and 1064 nm) opens up a broad field of treatment options for the user.
The modern microprocessor control and the accurate device for power measurement enable
simple and low-risk use.
The modern, clear colour display showing all therapy-related parameters and the modern
touch operation ensure enjoyment and motivation during treatment.
Individual program start settings and clear, simple menus offer the user maximum
convenience.
Note:
The application of the device is reserved for medical professionals (such as physicians,
therapists and health paraprofessionals).

System set-up
6.1 Safety measures
6
Page 10
Safety measures
Affix a laser warning sign including light to each door to the treatment room.
Remove the laser warning sign sticker from the sheet enclosed with the device and affix it
visibly to the device.
Select a sticker in a language which can be understood by all employees.
The laser protection officer must ensure proper application of safety features.
When not in use, the device should be protected against unauthorised use by operating the
code button.
Note:
Make sure that the main switch of the device is set to “0”.
Ensure that all persons present in the treatment room are wearing protective glasses.
Ensure that the applicator (5) is fully pushed into the test sensor (7).

System set-up
6.2 Assembly and start-up
6
Page 11
Power cable assembly
Connect the power cable to the provided port (11) on the device and connect the cable to the
mains.
Interlock plug
Connect the interlock plug (5) to the provided port (13) on the device.
Switch device on
Switch on the device using the main switch.
Enter code
The code must be entered after each time the device is switched on.
Enter the code 1234 and confirm with “OK”.
If an incorrect code is entered, this is displayed by a message.
After activating the “OK” button, the entry can be repeated.
Select therapy screen
Activate the “Therapy” button.
Adjust intensity
Adjust the desired output.
Attach spacer
Place the spacer (1/2) on the applicator.
Activate laser
Activate the laser by pressing the “Start” button.
Applicator
Place the applicator in the correct position in the treatment area.
Start of therapy
The therapy begins by pressing the manual switch on the applicator.
End of therapy
Releasing the manual switch interrupts or terminates the therapy.
Remove the spacer from the applicator after the therapy and insert the applicator into the test
sensor.
Note:
The foot switch is not included in the standard scope of delivery of OptonPro.
Operation using the foot
switch
Connect the foot switch to the port provided (9) and put it on the floor.
Activating the foot switch starts the therapy.
Deactivating the foot switch interrupts or terminates the therapy.