Enraf Nonius Endolaser 120 User manual

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Endolaser 120
EN109-1633750-40 IFU
December 16, 2019
Instructions for use

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Table of contents
1Introduction ......................................................................................................................................................3
2Description-symbols used and device markings ................................................................................6
3Device components .......................................................................................................................................8
4Package contents......................................................................................................................................... 10
5Installation ...................................................................................................................................................... 11
6Intended use and intended user............................................................................................................ 14
7Indications ...................................................................................................................................................... 15
8Contra-indications....................................................................................................................................... 16
9Precautionary instructions........................................................................................................................ 17
10 Operation........................................................................................................................................................ 20
11 Application information............................................................................................................................. 34
12 Maintenance and troubleshooting........................................................................................................ 38
13 Specifications................................................................................................................................................. 41
14 Contact............................................................................................................................................................. 44
15 Product liability............................................................................................................................................. 44

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1Introduction
Foreword
We are pleased that you have purchased an Endolaser 120.
The Endolaser 120, designed and manufactured by Enraf-Nonius B.V., offers a new dimension in low
level laser therapy (LLLT), made possible by advanced hardware and software design.
The result is a device with extraordinary versatility based on simplicity of operation.
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.
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 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.

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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 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.

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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.

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2Description-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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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.
Explanatory label affixed to laser probe
cable

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3Device components
Parts Description
Numbered
Part
Description
Purpose
[1]
LCD Touch Screen
Color TFT display 4.3” with touch screen.
Displays the User Interface that allows the
operator to control the device and change
parameters of treatment protocols.
[2]
Reference label
Provides information about the device, such as
type and serial number, as well as connection
data such as mains voltage and maximum
current consumption.
[3]
Mains switch
To switch the unit on and off
When turning the unit off the display remains
visible for a few seconds (low-energy method).
[4]
Connector for Mains Cable
Connect supplied Mains Cable here to power
the device.
[5]
Laser Probe LED indicator
Shows status of probe
Green: Laser ready
Orange: Laser active
[6]
Laser Probe Trigger
Activation/deactivation of laser
[7]
Laser Probe
Applicator for laser therapy

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Parts Description
Numbered
Part
Description
Purpose
[8]
Laser Aperture Cluster Diode
Opening for laser beam
[9]
Connection Laser Probe Holder
Connect Laser Probe Holder here
[10]
Remote Interlock
Connection to external Remote Interlock
system at the back of the Laser Probe Holder
[11]
Emergency Stop Button
Immediately abort laser output
[12]
Laser Probe Holder
Holder for Laser Probe
[13]
Connection Laser Probe A
Connect Laser Probe applicator left-hand side
here
[14]
Connection Laser Probe B
Connect Laser Probe application right-hand
side here
[15]
Laser Aperture Single Diode
Opening for laser beam

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4Package contents
Below mentioned Standard accessories will be contained in the main device packaging.
Device
Article number
Description
1633.901
Endolaser 120 with 1 holder, without Laser Probe
1633.902
Endolaser 120 with 2 holders, without Laser Probe
Standard accessories
Article number
Description
1633.750
Instruction for Use (PDF on CD-ROM)
1633.751
Information Booklet
3444.820
Laser Safety Eyewear (2 goggles included)
3444.357
Mains Cable 250V/2.5A, 2.5 meters black
Optional accessories
Article number
Description
1633.850
Laser Probe Holder
1632.801
LP100P (905 nm, 100 mW pulsed single Laser Probe)
1632.802
LP500C (808 nm, 500 mW continuous single Laser Probe)
1632.803
CP4X100C (808 nm, 4x100 mW continuous cluster Laser Probe)
1632.804
CP4X400C (808 nm, 4x400 mW continuous cluster Laser Probe)
Ordering information
For the ordering data of the Endolaser 120, standard accessories and optional accessories we refer
to our website www.enraf-nonius.com.

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5Installation
Inspection
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.
Immediately upon unpacking the device, perform the following steps:
•Verify the delivery documents to make sure that the delivery is complete.
•Verify that the packaging contains all the items listed in the standard accessories list
(Refer to chapter 4 - Package Contents in this manual).
•Check the external components and accessories for possible damage due to transport.
Unpacking
Endolaser equipment is specially packaged for transport in a single pack complete with filling which
has been specifically designed for safe transportation and storage.
•To remove the equipment from the pack, place the box on a smooth, flat surface.
•Open the top of the box and remove the polystyrene filling.
•Be very careful when removing the contents of the pack.
Connection to Mains supply
Use of any other cable other than the supplied power cable is strictly PROHIBITED as it
affects patient safety and the proper functioning 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 that is in compliance with 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.
Plug in the device to a wall socket using the Mains cable.
•Insert the Mains cable into socket [4] and connect it to a wall socket.
•Connect the Laser Probes to socket [13] or [14] (red plug into red socket) on the Laser Probe
Holder.
Disconnection of Mains supply
•When you have finished treatment, turn the device off by switching the Mains switch to Off.
•Disconnect the Mains cable from the wall socket.
•Disconnect the Mains cable from socket [4].

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Remote Interlock
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.
The Endolaser 120 contains a Remote Interlock which is located on the Laser Probe Holder. It can be
recognized by the Remote Interlock symbol:
The Remote Interlock contains a DC jack at the back of the Laser Probe Holder, which can be
connected with an external Remote Interlock system. The machine WILL NOT WORK without the
Remote Interlock in the closed/shorted position.
When operating with two probes, the supplied holder link cable will need to be used to bridge the
two remote interlocks together.
The Remote Interlock interrupts the power supply to the attached probes and will require a power
OFF/ON switching of the device to restart.
If an external Remote Interlock circuit is required, a twisted pair must be provided with a minimum
diameter of 0.6 mm, 20 m max.
On the safety circuit side, a microswitch with one normally closed path must be provided.
This circuit is an external safety device: it allows interrupting laser therapy treatments if a door is
opened inside the room where the treatment is delivered.
If the room where the laser therapy treatment is provided has only one point of entry (one door),
the configuration is as follows:
DC Jack
Reed / Proximity Switch
If the room where the laser therapy treatment is provided has two or more point of entries (multiple
doors), the configuration is as follows:

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Reed / Proximity Switch Reed / Proximity Switch
DC Jack

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6Intended 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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7Indications
The Endolaser 120 can be used for the below mentioned symptoms or medical conditions:
Indications
•Dermal wounds (open wounds, chronic ulcers, pressure sores)
•Arthritic conditions (Rheumatoid arthritis, osteoarthritis)
•Acupuncture and (myofascial) trigger points
•Soft-tissue injuries (muscle tears, bruising, hematoma)
•Tendinopathies
•Pain relief of various etiologies:
oNeck / Low Back pain
oArthrogenic pain
oNeuropathic and neurogenic pain, including herpes/postherpetic pain
•Temporomandibular disorders
•Carpal tunnel syndrome
Precautions
Low Level Laser Therapy can be applied with caution:
•Over infected tissue (e.g. infected open wound)
•Over the sympathetic ganglia, vagus nerves and cardiac region in patients with heart disease
•Over photosensitive areas
•Patient with epilepsy
•Areas of altered skin sensation
•Areas with Tattoos
Experienced clinicians may use Low Level Laser Therapy (LLLT) with caution (e.g. at lower intensities
and/or with closer monitoring) to treat the above mentioned conditions/locations.
Tattoos can absorb more light energy and may cause a negative skin reaction. It is generally
recommended that a “patch test” be done in a small area. In addition, it is a good precaution to
reduce the dosage to 50-75% of a recommended dosage when treating in the region of a tattoo.

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8Contra-indications
The Endolaser 120 MUST NOT be used for the below mentioned symptoms or medical
conditions.
Contra-indications
Low Level Laser Therapy should not be applied to:
•eyes
•over the low back, abdomen or pelvic region during pregnancy or menstruation
•regions of known or suspected malignancy
•actively bleeding tissue or persons with untreated haemorrhagic disorders
•regions with recently radiated tissues (for 6 months following irradiation)
•tissues infected with tuberculosis or other forms of virulent bacteria
•persons with impaired cognition or communication
•regions with active deep vein thrombosis or thrombophlebitis
•persons with photosensitivity disorders (xeroderma pigmentosum) or systemic lupus
erythematosus
•reproductive organs (testes)
•over areas of decreased sensation
•over the thyroid gland
•over the heart or vagus nerve of cardiac patients
•persons with infections who have a compromised immune function
•persons with epilepsy
Note(s):
1. Metal and plastic implants, as well as pacemakers, are not contra-indicated and LLLT can be used safely.
2. The listed contraindications apply to both continuous and pulsed modes.
Potential adverse effects
•Photosensitive reactions: in some cases, patients may experience photosensitive reactions as
a result of the use of known pharmaceuticals. It is not yet clear why the combination of laser
treatment and such drugs cause this type of reaction in some patients. Patients who suffer from
allergies should firstly be tested using the minimum time length of treatment.
•Devices: metal or plastic plates and pacemakers do not constitute any contra-indications for
the use of laser. The laser can be used safely on patients with metal or plastic implants, on
stitches and on patients with pacemakers.

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9Precautionary 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.

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10 Operation
Set Up
Do not use the device after extreme temperature fluctuations!
Frequently Used Functions
Selecting the Clinical Protocols, Favorite and Manual Operation buttons in the touch screen.
Switch On
Do not leave the device switched on unattended, always switch off at the end of use to avoid
use by unauthorized personnel.
•Optional: Connect the Remote Interlock connector to socket
•Switch the unit On by pushing the On/Off Button at the back of the unit.
•After switching on the device will initialize and a welcome screen will be displayed while the
device performs a self-test.
•At the end of the self-test the device enters the Key control screen.
Key Code Control
Endolaser 120 should be protected against
unauthorized use, by entering user defined key
code to unlock the device.
The device is protected with a key code control. A
user defined key code allows access to the
graphical user interface. Without this key code the
device will not operate.
Enter the key code to unlock the device.
The default code is 1234. The default code must
be changed in the settings menu.
After unlocking the device, the Home Menu is
displayed. The device is ready for use.
When the device has been inactive for longer
period of time, the key control screen will
reappear. Unlock the device with the key code to
continue.
Note: In case the user defined key code has been
forgotten, use the recovery code 102030661 to
reset to default code 1234.