Enraf Nonius Endolaser 120 Installation and operation manual

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Endolaser 120
Information Booklet
EN109-1633751-41 BKL
February 25, 2021
1Contact
Please read the Instructions for Use, (PDF on CD-ROM) before using the device. Instructions can be
read in Acrobat Reader, available free from the Adobe website.
If the CD is not readable, please contact us.
The latest version (in electronic or printed format) of the Instructions for Use can be obtained free of
charge from our website http://www.enraf-nonius.com or by contacting distributor or by calling the
telephone number: [phone]. The Instructions for Use will be sent (free of charge) to you
within 7 (seven) calendar days.
For assistance, please visit our website http://www.enraf-nonius.com
It is important to read the following instructions carefully before using this device
properly and safely. The manufacturer cannot be held responsible for the results of using
this device for any purposes other than described in these operating instructions.
If the use of this device may have caused or contributed to an undesirable event such as
death or serious injury to the user, the manufacturer AND the competent authority of the
Member State MUST be notified immediately!
2Introduction
Device Description
The Endolaser 120 is a multi-wavelength low level laser therapy device. It is equipped with a full color
touch screen in a PC-ABS plastic housing. The user-friendly interface includes pre-set clinical
protocols, parameters that can be set manually and favorites that can be created and stored for future
use.
The Endolaser 120 can be used with four different types of Laser Probes:
•LP100P (905 nm, 100 mW pulsed single Laser Probe)
•LP500C (808 nm, 500 mW continuous single Laser Probe)
•CP4X100C (808 nm, 4x100 mW continuous cluster Laser Probe)
•CP4X400C (808 nm, 4x400 mW continuous cluster Laser Probe)
The mounted applicators provide (depending on type) 808 nm or 905 nm laser light. Depending on
the area of treatment, single diode and cluster applicator types are available. The 905 nm GaAs
(Gallium-Arsenide) Laser Probe delivers pulses in nanoseconds, producing average powers of 100 mW

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and peak powers up to 100 W per diode. This results in a higher concentration of light energy or
photon density at tissue depth, without the risk of burning tissue. The 905 nm GaAs pulsed laser is the
most versatile for deep lying structures (joints, vertebrae, back(muscles)), whereas the 808 nm GaAlAs
(Gallium-Aluminium-Arsenide) continuous laser is more appropriate for wound healing and tissue
repair.
The Endolaser 120 will automatically recognize the probe that is connected. The user can connect two
laser probes to the device, which offers the convenience of not having to disconnect a probe and
reconnect a different probe. Only one channel can be active at a time. Activation of each applicator
can be controlled from the laser menu and in combination with the trigger on the probe.
The Endolaser 120 has been designed with safety in mind. It contains key control unlocking, Remote
Interlock system, Emergency Stop and laser protective goggles, to protect against potential hazards.
Device Design
The main product features of this device are:
•Laser Probe(s)
•(Smart) Holder for Laser Probe
•Target Light
•Laser Trigger on the Probe
•Embedded electronics inside the probe
•Ergonomic design
•LCD touch screen
Principle of Operation
The Endolaser 120 contains a mains electricity (AC-powered) diode laser intended to be used to
provide low-level laser therapy (LLLT) for a variety of clinical applications (e.g., to treat pain, promote
healing of wounds/injuries/disorders of the joints and soft/connective tissues, for non-needle
acupuncture). It consists of an electronic control with a connected applicator to generate laser light in
the range infrared frequencies (808 nm and 905 nm). It is intended to be operated by a healthcare
provider in a clinical setting.
Four well accepted effects in the scientific literature are:
•Biostimulation / Tissue Regeneration
•Reduction of Inflammation
•Analgesia
•Enhanced Immune Function / Antimicrobial
One important way in which laser therapy adds energy is through photon absorption by mitochondria.
These tiny organelles which have been called the "powerhouses" of the cell, are found in most plants
and animals. Mitochondria are able to absorb laser light which then activates a series of reactions to
increase and store more cellular energy in the form of adenosine triphosphate (ATP).
By increasing energy available in this readily accessible form, laser light is able to greatly stimulate the
biological function of cells, tissue, and systems and even raise overall vital energy throughout the
individual.
Laser therapy has been shown to stimulate the regeneration of bone, blood, the lining of blood
vessels, cartilage, cochlear hair cells, central and peripheral nerve, and muscle. Moreover, it has been
documented to enhance the quality of healed tissue. Laser therapy may be an ideal treatment. It may

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not only effectively address many medical conditions but also has been widely reported to improve
health and wellbeing as evidenced by a host of biological markers.
Method of Operation
The Endolaser 120 works by delivering coherent laser light to the patient. The type of laser light is
determined by the laser diode. There are four types of probes (single/cluster and 808nm/905nm
wavelength).
When the treatment screen is entered through the navigation, its parameters are initialized to factory
defaults or set to values as specified in a clinical protocol or favorite. The parameter defaults are Laser
Probe dependent. The device will automatically recognize the connected Laser Probe.
The treatment parameters are based on the definition of the treatment dosage:
Treatment Dosage
D = I x t (Joule/cm2) I=Power Density (Watt/cm2), t=time (sec)
I = P / A (Watt/cm2) P=Power (Watt), A=Area (cm2)
In clinical protocols mode, all the parameters are preset.
In manual operation mode, the treatment dosage can be directly set in the user interface by selecting
the preferred parameters. Two operation modes are available.
1) Points (cm2)
2) Milliwatt
In the “points (cm2)” mode, the number of treatment points (calculated as per cm2and joule per point
can be set. The operation time will be automatically calculated. When using points operation mode,
the probe will beep and pause when it is time to move to the next point.
In the milliwatt mode, the time and dosage can be set. The total dosage is then automatically
calculated.
3Intended use and intended user
Intended use
The Endolaser 120 is a Low Level Laser Therapy (LLLT) unit. The treatment is based on a light source
that generates light of a single wavelength. LLLT emits no heat, no sound, or vibration. The light
energy absorbed into the patient’s tissue, triggers biological changes at a cellular level.
Intender user
The Endolaser 120 is intended to be used, and shall only by used, by or under the supervision of
professional users in the field of physical medicine and rehabilitation at professional healthcare
facilities.

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4Description-symbols used and device markings
Symbol used
Description
Follow the instructions in the Instructions for Use.
It is important that you read, understand and observe the precautionary and
operating instructions
General Prohibition Sign.
Prohibition is used to mean “You MUST NOT”
Warning or Caution:
Indicates a hazardous situation which, if not avoided, could result in:
a. Death or serious injury to the patient (or)
b. Minor to moderate injury to the patient (or)
c. Damage to the equipment
General Mandatory Action Sign.
Mandatory action is used to mean, “You must…”
Type B applied part complying with the specified requirements to provide
protection against electric shock, particularly regarding allowable patient
leakage current and patient auxiliary current.
Temperature Range.
Indicates acceptable temperature range.
Humidity Limits.
Indicates acceptable relative humidity.
Atmospheric Pressure.
Indicates the range of atmospheric pressure to which the medical device can
be safely exposed.
Waste electrical items that can be recycled.
Indicates that the electrical and electronic components of the device can be
recycled and have to be disposed of separately.
Keep the device dry.
Manufacturer name, address and date of manufacture.
Reference Number or Part Number.
Serial Number
Indicates the serial number so that a specific medical device can be
identified.

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Alternating current
“ON” (power)
“OFF” (power)
CE Mark along with number indicates conformity with European Council of
Directive concerning Medical Devices and that this device is under the direct
supervision of the Notified Body.
Emergency Stop button.
Laser aperture indicates laser opening.
Warning: laser radiation.
Remote Interlock.
Avoid direct eye exposure.
Label affixed to laser probe cable

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5Precautionary instructions
If the use of this device may have caused or contributed to an undesirable event such as
death or serious injury to the user, the manufacturer AND the competent authority of the
Member State MUST be notified immediately!
The device is not intended for use in so-called "wet rooms" (hydrotherapy rooms).
Caution –Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
A risk of fire and/or explosion exists when the laser output is used in the presence of
flammable materials, solutions or gases, or in an oxygen enriched environment.
Do not operate the laser when the aperture covers are removed. Focal point of the beam may
cause burns.
In case any damage is noticed after unpacking the device, please immediately contact your
local distributor. DO NOT USE the device!
Good air circulation is essential to prevent internal heat build-up. Do not install the unit in a
location near heat sources such as radiators or air ducts, and prevent exposure to direct
sunlight.
The unit should be installed in such a way, that its warmth can be passed on to the
surroundings. Do not cover the ventilation openings.
Use of any other cable other than the supplied power cable is strictly PROHIBITED as it
affects patient safety and the proper function of the device.
Before connection of the device to the local Mains, check that the Mains voltage and
frequency stated on the identification plate of the device corresponds with those of the local
Mains.
Make certain that the device is electrically grounded by connecting only to a grounded
electrical service receptacle conforming to the applicable national and local electrical codes.
Do not place the device in a location where the power cord could pose a possible tripping
hazard or could be pulled out of the wall socket during treatment.
Take care with connecting the Laser Probes. Sharply bending or improperly securing the
probes, could lead to damage to the probe and/or harm to the patient or laser operator.
If you want to install the Remote Interlock circuit, contact only qualified technicians and
provide these professionals with the scheme that complies with the configuration of the
treatment room. Failure to properly install the device could result in serious eye damage.
Do not use the device after extreme temperature fluctuations!
Do not leave the device switched On unattended, always switch Off at the end of use to avoid
use by unauthorized personnel.
Before starting treatment make sure you have read and understood the content of this
manual.
Before starting treatment make sure you strictly follow the WARNINGS and CAUTIONS
mentioned under precautionary instructions
This device should be used only under the continued supervision of a physician or licensed
practitioner.
This device should be kept out of the reach of children.
The patient and the device must be in sight of the therapist at all times.
Connection of accessories other than the ones specified by the manufacturer can adversely
affect the safety of the patient and correct functioning of the equipment, and is therefore not
permitted.

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Laser treatments must be delivered under the strict control of the operator to conscious
patients who are able to interact with the operator in response to stresses transmitted by the
machine. In case of non-compliance with the information provided, Enraf-Nonius B.V. will not
be held responsible for any accidents.
It is the responsibility of the operator to verify that the emitting head remains well adherent
to the treatment area, in order to avoid the emission of the laser in areas other than those to
be treated.
Never turn the handpiece to the parts of the body sensitive to the laser rays, for example the
eyes.
Do not look at the target beam area emitted by the handpiece or the direct reflections during
treatment without protective goggles.
The laser radiation coming out of the device is dangerous: always use the appropriate
protective goggles. Always avoid eye exposure to direct or diffuse laser radiation.
Before performing any user maintenance, switch off the device and disconnect the plug from
the Mains supply.
Do not spray the cleaning agent directly on the glass panel.
Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride or
detergents with ammonia.
Use no liquid detergents, these can damage the device.
Do not allow any liquids to penetrate the device or its accessories while cleaning and
disinfecting!
Dry all sockets and connectors that have become wet before any further use!
Solvents used for cleaning and disinfection should be allowed to evaporate before the laser
equipment is used.
Mechanical shocks /or vibrations must be avoided while cleaning the device.
Do not drop the device.
The device should not be used when mechanical damage is noticed. This includes damaged
cable insulation.
In the event that an error message or warning appears, immediately stop all use of the device.
Shutdown and restart the device. If the problem persists contact the supplier or Enraf-Nonius
B.V. for service. Errors and warnings indicate an internal problem with the device that must be
tested by a field service technician certified by Enraf-Nonius B.V before any further operation
or use of the system.
Use of a device that indicates an error or warning may pose a risk of injury to the patient,
user, or extensive internal damage to the system.
In case of failure of the display or other obvious defects, unplug the device immediately and
notify a certified service technician.
In the case of ingress of liquids, unplug the device from the Mains supply and have it checked
by an authorized person.
Only service Technicians authorized by Enraf-Nonius B.V. can perform maintenance or modify
this equipment according to current Service Information.
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe use of the equipment.
Maintenance shall not be performed on the equipment when equipment is in use or
connected to a patient.
Medical electrical devices such as the Endolaser 120 are subject to special precautions with
regard to electromagnetic compatibility (EMC) and must be installed and commissioned in
accordance with the EMC advice given in the Instructions For Use.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the
other equipment should be observed to verify that they are operating normally.

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Use of accessories, probes and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm to any part of the Endolaser 120,
including cables specified by the manufacturer. Otherwise degradation of the performance of
this equipment could result.
The Endolaser 120 should only be operated with the original power cable specified in the list
of contents delivered. Operating the device with any other power cable can lead to increased
emissions or reduced interference immunity of the device.
6Package contents
Device
Article number
Description
1633900
Endolaser 120 base unit
1633901
Endolaser 120 with 1 holder, without Laser Probe
1633902
Endolaser 120 with 2 holders, without Laser Probe
Standard accessories
Article number
Description
1633750
Instruction for Use (PDF on CD-ROM)
1633751
Information Booklet
3444820
Laser Safety Eyewear (2 goggles included)
3444357
Mains Cable 250V/2.5A, 2.5 meters black