Zimmer OptonPro User manual

Instructions for use
OptonPro
25 Watt
USA

Illustrations
Front of the device
Fig. 1
Selection and operating
elements
1 Control unit
2 Display
3 Emergency stop button
4 Main switch
Applicator with fibre optic
5 Applicator
5.1 Manual switch
5.2 Integrated infrared sensor and laser aperture
6 Fibre optic cable
Test sensor
7 Test sensor and applicator holder
1
2
3
4
5
6
7
5.1
5.2

Illustrations
Rear of the device
Fig. 2
Ports
8 Fibre optic outlet
9 Footswitch connector
10 Identification plate
11 Mains connector
12 Main fuse
13 Interlock connector
14 USB connector
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 line
Fig. 4
Navigation menu /
status line
Description of the
functions
(A) Therapy
Switches to the therapy screen
(B) History
Switches to the VAS history
(C) Favourites
Switches to the favourites list
(D)Protocols
(E) Back
Switches to the Protocols
Back to previous screen or to the start-up screen
(F) Save
Save
(G) Performance test
Performance test level
2
3
4
1
A
B
E
F
G
C
D

Illustrations
Accessories
1 Spacer, small
2 Spacer, large
3 Foot switch (optional)
4 Laser warning sign with laser
warning light
5 Laser Warning Sign OptonPro
25W
6 Protective laser glasses
7 Interlock plug

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
Foot switch connector
Interlock connector
Rating of the accessible fuses
Protection class II
Operating instructions
Follow instructions for use
Serial number
Catalogue number
Manufacturer
Date of manufacture
General Warning Symbol on the device
Beam aperture
USB 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.
U.S.A Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner licensed by the law of the State in which he/she practices to use or order the use
of the Device.

Explanation of Symbols
Text with “Caution” indicator in the instructions for use will explain possible safety
infractions that could have the potential to cause minor to moderate injury or damage to
equipment.
Text with “Warning” indicator in the instructions for use will explain possible safety
infractions that will potentially cause serious injury and equipment damage.
Text with “Danger” indicator in the instructions for use will explain possible safety infractions
that are imminently hazardous situations that would result in death or serious injury.

Contents
Figure
Front of the device
Rear of the device/switches and ports
Display views/navigation menus
Accessories
Explanation of Symbols
Page
1
Indications for Use
1
2
Contraindications / Side effects
2
3
Safety Information / Warnings
3
4
Application information
9
5
OptonPro 25W –in brief
12
6
System set-up
6.1 Safety measures
6.2 Assembly and start-up
13
14
7
Configuration
15
8
Operation Instructions
8.1 Performing a treatment
8.2 Displays and buttons
8.3 Thermal threshold test
8.4 Protocols
8.5 Favourites
18
19
23
25
26
9
Technical Information
27
10
Cleaning / Disinfection
29

Contents
11
Manufacturer
30
12
Scope of Delivery, Accessories
31
13
Device Combinations / Safety and Maintenance /
Functional Test
32
14
Error messages / Troubleshooting / Disposal
33
15
Manufacturer's EMC declaration
34
The 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: September 2020
U.S.A. Federal Law restricts this device to sale by or on the order of a practitioner
licensed by the law of the State in which he/she practices to use or order the use of the
device.

Indications for Use
1
Page 1
Indications for Use The OptonPro 25W is indicated to provide topical heating for the purpose of elevating
the tissue temperature for the:
temporary relief of minor muscle and joint pains and stiffness
temporary relief of muscle spasm
temporary relief of minor pain and stiffness associated with arthritis
temporary relaxation of the muscle
temporary increase of local blood circulation

Contraindications / Side effects
2
Page 2
Contraindications
The OptonPro 25W should not be used:
over areas of fresh haematoma and active hemorrhage
over a pregnant uterus
over malignant, semimalignant and benign tumours and even over areas that are
suspicious or contain potentially cancerous tissue
for treatment in the vicinity of the eye, over or applied to the eye
during menstruations in the abdominal region and the lower back
where analgesia may mask progressive pathology, and where the practitioner would
normally avoid the use of any other analgesia in order to retain the beneficial aspects of
pain.
over areas injected with steroids in the past 2-3 weeks
over the neck (thyroid or carotid sinus region) or chest (vagus nerve or cardiac region of
the thorax)
directly over areas with open wounds
treatment over sympathetic ganglia
for sympathetic local pain relief unless ethology is established or unless a pain syndrome
has been diagnosed
on patients suspected of carrying serious infectious disease and or disease where it is
advisable, for general medical purposes, to suppress heat or fevers.
over or near bone growth centers until bone growth is complete
over the thoracic area if the patient is using a cardiac pacemaker
on ischemic tissues in individuals with vascular disease where the blood supply would be
unable to follow the increase in metabolic demand and tissue necrosis might result.
Possible adverse side
effects
Particular caution is required when administering treatment near the ear, nose, mucous
membrane 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.
To avoid possible adverse side effects pay attention to the Precautionary Instructions and
Application Instructions in chapter 3 and 4!
In the event of improper use of laser radiation, the application of radiation can cause damage
to skin and equipment.
Additional examples for possible adverse side effects are:
Smoke formation
Danger of fire and explosion
Electrical hazards
Fibre breakage and emission of radiation
The human eye is particularly sensitive. Damage to the eye usually causes irreparable
malfunction. Take great care!

Safety Information / Warnings
3
Page 3
Precautionary Definitions
The precautionary instructions throughout the manual are indicated by specific symbols.
It is important to understand these symbols and their definitions before operating this
equipment. The definition of these symbols are as follows:
Text with “Caution” indicator will explain possible safety infractions that could
have the potential to cause minor to moderate injury or damage to equipment.
Text with “Warning” indicator will explain possible safety infractions that will
potentially cause serious injury and equipment damage.
Text with “Danger” indicator will explain possible safety infractions that are
imminently hazardous situations that would result in death or serious injury.
Note:
Throughout this manual “Note” may be found. These notes are helpful information to aid in
the particular area or function being described.

Safety Information / Warnings
3
Page 4
Read, understand and practice the precautionary and operating instructions. Know the
limitations and hazards associated with using any laser light device. Observe the
precautionary and operational decals placed on the unit.
Use of controls, adjustments, performance of procedures other than those specified herein
may result in hazardous exposure to laser light energy. Failure to use and maintain the
OptonPro 25W and its accessories in accordance with the instructions outlined in this manual
will invalidate your warranty.
Electrical devices emit electromagnetic fields during operation that may interfere with other
devices. If in doubt, keep a sufficient distance from possible sources of interference, shield
the device or avoid operating such devices at the same time. Portable and mobile RF
communications equipment can affect Medical Electrical Equipment. Minimize this by not
using other equipment with the OptonPro 25W.
The device may be opened by service technicians authorized by Zimmer MedizinSystems
only.
DO NOT remove the cover, disassemble, modify, or remodel the unit or accessories. This
may cause unit damage, malfunction, electrical shock, fire or personal injury. There are no
user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately
and consult the dealer for repair service.
To avoid the risk of electric shock, the device must be disconnected from the mains supply
before any maintenance or cleaning activities by pulling the power plug.
DO NOT use sharp objects such as pencil point or ballpoint pen to operate the buttons on the
touch screen as damage may result.
DO NOT permit any foreign materials or liquids to enter the unit. Take care to prevent any
foreign materials including, but not limited to, inflammables, water, and metallic objects from
entering the unit. These may cause unit damage, malfunction of internal components of the
system, electrical shock, e.g. and therefore create a risk of injury to the patient.
During application the device must be placed in a position in which direct access to the
central power of the device is possible, so that it can always be disconnected from the mains.
Before use, ensure that the device is operated with a properly connected socket with
protective earth. The device must be operated with the supplied power cord. The power cord
must be protected against mechanical stress.

Safety Information / Warnings
3
Page 5
The device must only be operated in compliance with these operating instructions. All other
applications take place at the operator’s responsibility. Be sure to read all instructions
(operating procedures for each treatment mode, indications, contraindications, warnings,
precautions etc.) for operation before treating a patient.
This device should be used only under the continued supervision of a licensed practitioner.
The device is designed for use by medical professionals only (e.g., doctors, therapists and
health paraprofessionals).
Use of the control elements or setting options in ways other than those described here can
lead to hazardous exposure to radiation or to hazardous conditions causing damage to the
unit and applicator! Observe all the relevant safety instructions!
Use only accessories that are specially designed for this unit. Do not use accessories
manufactured by other companies on this (table, unit, device, etc.). Zimmer MedizinSystems
is not responsible for any consequences resulting from using products manufactured by other
companies. The use of other accessories or cables may result in increased emissions or
decreased immunity and safety of this unit.
Make certain that the unit is electrically grounded by connecting only to a grounded electrical
service receptacle conforming to the applicable national and local electrical codes.
The device must not be operated if there is visible damage to the device, the fibre-optic cable
or the applicator. Call customer service.
a. Inspect the output lens of the laser head for blemishes, deformation,
pitting, scratches, discoloration and cleanliness before each use.
b. Inspect applicator cables and associated connectors before each use.
Before each use clean the lens. Failure to clean the lens will cause beam fragmentation.
The fibre-optic cable and applicator are very sensitive optical systems. Use and handle them
with care. All of the following conditions will damage the applicator and unit. Damage can
adversely affect its characteristic and is not covered under the warranty:
a. Do not drop the applicator or unit on hard surfaces.
b. Do not submerge the applicator or unit in water. Protect them against soiling.
c. Never kink the fibre-optic cable and protect it against tension.
The OptonPro 25W must never be operated if the device, the fibre-optical cable or the
applicator is damaged visibly
The use of flammable anaesthetic gases or oxidizing 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.
Never bend the light guide and protect it from tensile stress. Damage to the light guide can
lead to undesired beam exposure.
Never unscrew the spacer sleeve on the front part of the applicator. Treatment without the
spacer sleeve or with an incorrectly mounted sleeve can lead to increased beam exposure or
to burns of the skin.

Safety Information / Warnings
3
Page 6
The unit integrates a class 4 laser. The accessible laser radiation is very
hazardous for the eye and hazardous for the skin. Diffuse radiation can also
be hazardous. Laser radiation can cause fire or explosion hazard. The laser
radiation delivered by the device is invisible.
All persons (including patients) must wear protective goggles when in the laser range!
DO NOT point the laser light beam directly into human or animal eyes. The lens of the eye
does not detect the invisible, coherent laser light beams, potentially resulting in permanent
retinal damage.
DO NOT connect the unit to an electrical supply without first verifying that the power supply
unit is the correct voltage. Incorrect voltage may cause unit damage, malfunction, electrical
shock, fire, or personal injury. Your unit was constructed to operate only on the electrical
voltage specified on the Voltage Rating and Serial Number Plate.

Safety Information / Warnings
3
Page 7
User group
The use of the OptonPro 25W 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 25W 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.
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.

Safety Information / Warnings
3
Page 8
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 9
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.
The device must only be operated with the supplied power cable. The power cable must be
protected against mechanical stress.
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.
The device may be opened only by service technicians authorised by Zimmer MedizinSystems.
The device does not contain any parts to be maintained by the user.
The complete medical system is suitable for use in the vicinity of the patient.
Contact components (spacers, applicator) must be cleaned and disinfected after each use.
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.
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.
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.
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 14).
The following factors may have an influence when applying laser light: colour of skin, age of
lesion, depth of lesion, sensitivity of the patient, tissue type and medications that increase
sensitivity to light.
Some patients are more sensitive to laser output (e.g., patients taking medications that increase
sensitivity to light) and may experience a reaction similar to a heat rash. As a general rule the
treatment should always be stopped / interrupted as soon as the warmth threshold is reached.
A warmth perception within the tolerance level is acceptable. Stop / interrupt the treatment and
lower the dosage if patient reports increasing warmth or feeling hot.
The recommended therapeutic skin temperature range is 40°C - 45°C. The current skin
temperature is displayed on the screen.
If a skin temperature > 45°C is measured by the temperature sensor in the applicator during
laser power application, the laser power output switches off automatically. If a skin temperature
of less than 40 °C is measured, then the laser device emits a beep.

Application information
4
Page 10
Protective Measures and
Equipment at the
workspace
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.
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.
Aiming Beam
A red aiming beam targets the treatment location. Please be aware that the laser light will be
applied into this direction.
Foot Switch
The footswitch is used to trigger the laser beam. Only press the footswitch if you have
previously directed the applicator to the part of the patient’s body to be treated. An acoustic
signal sounds while the laser radiation is being delivered. Position the footswitch such that it
cannot be pressed inadvertently or actuated by unauthorized persons.
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.
Warning sign
The warning sign must be affixed at the entrance to the laser area. The laser area is marked
in sign. The entry to the laser area is usually the door of the treatment room. If there are
several doors, all doors have to be marked with this sign, or non-used doors are to be closed
before starting up the laser. If the laser area comprises an area separated off from the
treatment room with curtains or a screen, the sign has to be affixed on the access side of the
area.
Warning lamp
The warning lamp has to be affixed in such a way that it can be seen from outside the laser
area and warns people of entering this area. This is usually the access door to the treatment
room or the access side of the screen. The lamp has to be switched on before starting up the
laser.
Interlock
Upon opening of the secured door (or if applicable several doors) the interlock switch
interrupts the laser beam. When the door is closed the beam is activated again. When the
door has opened, the footswitch has to be released immediately.
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; 980 nm and 1064 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 25W.