Zimmer OptonPro User manual

Instructions for Use
OptonPro
USA

Figures
Front view of device
Fig. 1
Selection and control elements
1 Control unit
2 Display
3 Emergency Off button
4 SD card slot
5 On/off switch
Applicator with fibre-optic cable and power control sensor
6 Applicator
7 Fibre-optic cable
8 Power control sensor and holder for applicator
1
2
3
4
5
8
6
7

Figures
Display
Fig. 2
Screen readouts
9 Status bar
10 Buttons on the screen
11 Title bar
12 Navigation bar
10
12
9
11

Figures
Rear
Fig. 3
Connector sockets
13 Footswitch socket
14 Interlock socket
15 Connector for mains cable
16 Holder for mains fuse
17 Name plate
18 / 19 Socket without function for OptonPro
20 Fibre-optic cable outlet
13
14
15
16
17
18 / 19
20

Figures
Accessories
Fig. 4
22 Spacer small
(optional)
23 Spacer
large
(optional)
24 Footswitch
25 Interlock key
26 Interlock switch
(optional)
27 Laser protective glasses
28 Laser warning sign and lamp

Explanation of symbols
Caution laser aperture
Turn the Emergency Off button in the direction of the arrows to unlock
Device type BF
Footswitch socket
Interlock socket
Value of the accessible fuses
The device is protection class II.
Follow operating instructions
Serial number
Article number

Explanation of symbols
Manufacturer
Date of manufacturing
In the user manual, this symbol stands for Caution.
Please refer to Precautionary Definitions.
In the user manual, this symbol stands for Warning.
Please refer to Precautionary Definitions.
In the user manual, this symbol stands for Danger.
Please refer to Precautionary Definitions.

Contents
OptonPro
Front view of device
Fig. 1 Selection and control elements
Fig. 2 Screen readouts
Rear view of device
Fig. 3 Connector sockets
Fig. 4 Accessories
Page
1
Indications, Contraindications, Safety Instructions
1.1 Precautionary Definitions
1.2 Indications
1.3 Contraindications
1.3.1 Contraindications
1.3.2 Additional Precautions
1.3.3 Possible adverse side effects
1.4 Precautionary Instructions
1.4.1 Caution
1.4.2 Warning
1.4.3 Danger
1.4.4 Application Information
1.4.5 Protective measures and equipment at the
workplace
1.5 Common terms
1
2
2
3
3
4
4
5
6
6
8
10
2
OptonPro – briefly 11
3
Installation
3.1 Safety measures
3.2 Installation, starting the system
12
13
4
Settings 14
5
Navigation bar 17
6
Instructions for use
6.1 General operation
6.2 Thermal threshold test
6.3 Saving programmes
6.4 Retrieving Favourites / Memory list, opening
programmes, editing list
20
28
30
32
7
Performance test 34
8
Key code 35

Contents
OptonPro
9
Technical data 36
10
Scope of delivery, accessories 38
11
Combinations 39
12
General instructions, SD card, accessories, service 40
13
Maintenance
13.1 Cleaning and Disinfection
13.2 Safety and Maintenance
13.3 Functional test
41
42
43
14
CE mark, legal information 44
15
Errors, troubleshooting, disposal 45
16
Manufacturer's EMC declaration 47
Valid for the OptonPro.
These operating instructions 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.
These operating instructions are valid from January 2015.
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 whi
ch he/she practices
to use or order the use of the device.

Indications, Contraindications,
Safety Instructions
1.1. Precautionary Definitions
1
1
The precautionary instructions throughout the manual are indicated by specific
symbols. 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.

Indications, Contraindications,
Safety Instructions
1.2. Indications / 1.3. Contraindications
1
2
Indications
The OptonPro is indicated to provide topical heating for the purpose of
elevating the tissue temperature for the:
•temporary relief of minor muscle and joint aches, pains, and stiffness
•temporary relief of muscle spasm
•temporary relief of minor pain and stiffness associated with arthritis
•promoting relaxation of the muscle tissue
•temporary increase of local blood circulation
Contraindications
The OptonPro 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, unless covered with a clear
protective barrier
•treatment over sympathetic ganglia
•for sympathetic local pain relief unless etiology 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.

Indications, Contraindications,
Safety Instructions
1.2. Indications / 1.3. Contraindications
1
3
Possible adverse
side effects
To avoid possible adverse side effects pay attention on the Precautionary
Instructions in chapter 1.4!
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
•Fiber breakage and emission of radiation
The human eye is particularly sensitive. Damage to the eye usually causes
irreparable malfunction. Take great care!

Indications, Contraindications,
Safety Instructions
1.4. Precautionary Instructions
1
4
Caution 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 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.
The device may be opened by service technicians authorized by Zimmer
MedizinSysteme only.
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 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.
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.

Indications, Contraindications,
Safety Instructions
1.4. Precautionary Instructions
1
5
Warning
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.
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 it’s 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 must never be operated if the device, the fibre-optical cable or
the applicator is damaged visibly.

Indications, Contraindications,
Safety Instructions
1.4. Precautionary Instructions
1
6
Danger
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.
Application
Information
To avoid skin damage, please observe the treatment guidelines.
Persons not involved in the treatment should leave the room or stay as far
away as possible (see: Laser range). All persons with access to the laser must
without fail be instructed about behaviour! Inform the patient about the
potential hazard of the laser. This device should be kept out of the reach of
children.
All persons (including patients) must wear protective goggles when in the laser
range!
When the laser is not in use, switch it off, place the applicator in the holder.
During treatment, the patient must be observed closely and the treatment
must be adjusted if necessary or discontinued should any problems develop.
Do not allow yourself to be distracted during treatment. If you turn your
attention away from the treatment, then first place the equipment at a safe
distance (release footswitch).
Do not treat through clothing.
Do not apply laser on an area of skin that has lotion or ointments applied and
don’t use it over or on a tattoo, as burns may occur.

Indications, Contraindications,
Safety Instructions
1.4. Precautionary Instructions
1
7
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.
Recommendation for therapeutic treatments:
The OptonPro has not been tested for the skin types V and VI.
The applicator always has to be in skin contact.
The recommended therapeutic skin temperature range is 40°C - 45°C. The
OptonPro warms the skin within this range at the following settings:
duty cycle
output power [W]
1:10
– 1:6
6 - 7
1:5
– 1:2 2 - 7
1:1
1 - 7
CW
1 - 7
Please note that no output power besides this range can be chosen.
Recommended treatment time: 10 min
Maximal transition time to reach the target temperature of 40°C: 5 min
Recommended total time: 15 min.
After a total time of 15 min the OptonPro warns the user that the
recommended treatment time is reached. (chapter 6.1 page 23)
Recommended transition time for representative settings:
output mode
output power [W]
recommended
transition time [min]
1 Hz, 1:10
6 - 7 3
10 Hz, 1:5
2 - 7
5
50 Hz, 1:1
1 - 7 3,5
CW
1 - 7
2

Indications, Contraindications,
Safety Instructions
1.4. Precautionary Instructions
1
8
Protective measures
and equipment at the
workplace
Power control sensor
The power control sensor enables measurement and balance of the output
laser radiation. The power control sensor also serves as the storage place for
the applicator after treatment and when the device is not in use. The applicator
is thus protected against soiling and damage.
Applicator
The applicator is on the end of the fibre-optic cable. The laser beam exits
through the front end of the applicator. The opening is protected against
soiling and damage by a lens. Point the applicator only in the direction of the
area to be treated. Never set it down outside the power control sensor.
Aiming Beam
A red aiming beam targets the treatment location. Please be aware that the
laser light will be applied into this direction.
Footswitch
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.
Emergency Off button
The Emergency Off button can be used to stop the operation of the device
immediately by disconnecting the power supply.
To stop operation, press the Emergency Off button until it locks and the device
switches off. To resume operation, return the button to its original position by
turning the red button in the direction of the arrows.
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.

Indications, Contraindications,
Safety Instructions
1.4. Precautionary Instructions
1
9
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, assistants) must
wear suitable protective glasses.
Use only protective glasses with an optical density of OD > 3 at 810nm and
980nm and a light penetration of at least 20% in the visible range. The glasses
must be heat and UV resistant and comply with EN 207 requirements.
Treatment room
•In the surroundings of the laser workplace there should be no reflective
surfaces (equipment, windows, walls, ceilings, fittings, pictures, mirrors,
e.g.). Ensure that any reflecting objects in the treatment area cannot
deflect the laser radiation. Matt-surfaced or diffusely scattering
instruments should be used if necessary.
•Ensure that the laser is not aimed uncontrolled at the surroundings
(instruments, stretcher, and furniture e.g.).
•Note that the laser radiation can escape through windows, glass doors or
other openings in the treatment room. Take the relevant protective
measures.
•The device is not intended for the use in explosive areas and /or
combustion-enhancing atmospheres. Avoid using combustible anaesthetic
gases or oxidising gases such as nitrogen oxide (N2O) and oxygen. When
saturated with oxygen, some materials, such as cotton, can ignite at high
temperatures which arise in normal operation of the laser equipment. The
solvents in adhesives and flammable solutions used for cleaning and
disinfection should be given time to evaporate before the laser equipment
is used. Caution is advised as well regarding the body’s own gases, which
can be flammable.
•Ensure that the working area of the laser is free of flammable substances.
Pay special attention to the patient’s clothing.

Indications, Contraindications,
Safety Instructions
1.5. Common terms
1
10
Continuous Wave (CW)
The output of the laser light is not interrupted during the treatment.
Serial Pulse
In this operating mode, the continuous wave is interrupted automatically briefly
at regular intervals.
Duty Cycle
This is the ratio of the “on” time to the “total” time of the cycle.
Dosage measured in Joules [J ] or Joules / cm2 [J/cm2]
intensity of the laser light over the treatment area
Energy measured in Joules [J]
treatment time multiplied by the power
Frequency measured in [Hz]
Power measured in Watts [W]
directly proportional to the treatment time
Power density measured in Watts / cm2[W/cm2]
ratio of the power divided by the treatment area
Treatment area measured in [cm2]
equal to area output spot size
area of tissue affected by the laser
Recommended treatment time measured in seconds [s]
recommended time to have a therapeutic effect
Transition time measured in seconds [s]
time it takes until the temperature has reached 40°C to achieve a therapeutic
effect
Recommended total time measured in seconds [s]
transition time + treatment time = total time

OptonPro - briefly
2
11
What is the
OptonPro?
The OptonPro is a topical heat lamp.
What does the
OptonPro do?
It emits energy in the infrared spectrum to provide topical heating for the
purpose of elevating the tissue temperature.
What is the
advantage of the
OptonPro?
The simultaneous application of laser light of two wavelengths
(810 and 980nm) opens up a wide range of therapy options for the user.
Modern microprocessor control and the precise mechanism of power
measurement make it simple and safe to use.
The clear and modern color display showing all parameters relevant for
treatment and the modern touchscreen control makes treatment motivating
and enjoyable.
Customized programs, start configurations and a clear, simple menu
navigation make operation of the device easy and convenient for users.
Note:
The device is designed for use by medical professionals only (e.g., doctors,
therapists and health paraprofessionals).