Enraf-Nonius Endolaser 422 User manual

Brand: Enraf-Nonius

Model: Endolaser 422

Type: User manual

Endolaser 422

User Manual

Vareseweg 127

3047 AT Rotterdam

The Netherlands

Tel: +31 (0)10 – 20 30 600

Fax: +31 (0)10 – 20 30 699

www.enraf-nonius.com

Part number: EN109-1422750-48

March 29, 2018

Endolaser 422

User Manual

Table of Content

1.1 This manual ..................................................................................................................... 5

1.2 Product liability ............................................................................................................... 5

2 INTENDED USE ................................................................................................................... 5

2.1 Indications ....................................................................................................................... 6

2.2 Contra-indications .......................................................................................................... 6

3 IN GENERAL ....................................................................................................................... 7

4 INSTALLATION ................................................................................................................... 7

4.1 Unpacking ........................................................................................................................ 7

4.1.1 Standard accessories: .................................................................................................................. 7

4.1.2 Optional accessories: ................................................................................................................... 7

4.1.3 Environmental conditions for normal use ................................................................................... 8

4.2 Electrical Connection ...................................................................................................... 9

4.3 Remote Interlock connector ........................................................................................... 9

5 OPERATING INSTRUCTIONS .......................................................................................... 10

5.1 Operation Information ................................................................................................... 10

5.2 Operation controls front panel ..................................................................................... 10

5.3 Operation controls rear panel ...................................................................................... 11

5.4 Turn on the apparatus .................................................................................................. 12

5.5 Main Menu ..................................................................................................................... 12

5.6 Default setting ............................................................................................................... 13

5.6.1 Set UP default settings .............................................................................................................. 13

5.6.2 Select Language ........................................................................................................................ 13

5.6.2.1 Display background ........................................................................................................... 14

5.6.2.2 Changing Contrast ............................................................................................................. 14

5.6.2.3 Changing Brightness .......................................................................................................... 14

5.6.3 Various settings ......................................................................................................................... 15

5.7 Basic Operation ............................................................................................................. 16

5.7.1 Manual Operation ..................................................................................................................... 16

5.7.2 Parameter Adjusting .................................................................................................................. 16

5.7.2.1 Select Program via Manual Operation ............................................................................... 17

5.7.3 Select Program .......................................................................................................................... 17

5.7.3.1 Load a programme on channel 2 ........................................................................................ 17

5.7.4 Create programs ........................................................................................................................ 18

5.7.5 Load the created programs ........................................................................................................ 19

5.8 Laser test ....................................................................................................................... 19

5.9 Therapy application ...................................................................................................... 19

6 MAINTENANCE AND TROUBLESHOOTING ................................................................... 20

6.1 User maintenance ......................................................................................................... 20

6.1.1 Cleaning the apparatus .............................................................................................................. 20

6.1.2 Cleaning laserprobes ................................................................................................................. 20

6.1.3 Fuse replacement procedure ...................................................................................................... 21

6.2 End of life ....................................................................................................................... 21

6.3 Troubleshooting ............................................................................................................ 21

6.3.1 Checklist.................................................................................................................................... 22

7 ELECTROMAGNETIC INTERFERENCE ........................................................................... 23

8 TECHNICAL SPECIFICATIONS ........................................................................................ 23

9 APPENDIX ......................................................................................................................... 24

9.1 Appendix A .................................................................................................................... 24

9.1.1 Environmental protection .......................................................................................................... 24

9.2 Appendix B .................................................................................................................... 24

10 DESCRIPTION-SYMBOLS USED AND DEVICE MARKINGS .......................................... 27

1 Foreword

1.1 This manual

This manual has been written for the owners and operators of the Endolaser 422. It contains general

instructions on operation, precautionary practices, maintenance and parts information. In order to

maximize the use, efficiency and lifespan of your unit, please read this manual thoroughly and become

familiar with the controls as well as the accessories before operating the unit.

Specifications put forth in this manual were in effect at the time of publication. However, owing to Enraf-

Nonius BV’s policy of continual improvement, changes to these specifications may be made at any time

without obligation on the part of Enraf-Nonius BV.

1.2 Product liability

A law on Product Liability has become effective in many countries. This Product Liability law implies,

amongst other things, that once a period of 10 years has elapsed after a product has been brought into

circulation, the manufacturer can no longer be held responsible for possible shortcomings of the product.

To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or

resellers be liable for any indirect, special, incidental or consequential damages arising from the use of or

inability to use the product, including, without limitation, damages for loss of goodwill, work and

productivity, computer failure or malfunction, or any and all other commercial damages or losses, even if

advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort or

otherwise) upon which the claim is based. In any case, Enraf-Nonius’s entire liability under any provision

of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for

support of the product received by Enraf-Nonius under a separate support agreement (if any), with the

exception of death or personal injury caused by the negligence of Enraf-Nonius to the extent applicable

law prohibits the limitation of damages in such cases.

Enraf-Nonius cannot be held liable for any consequence resulting from incorrect information provided by

its personnel, or errors incorporated in this manual and / or other accompanying documentation (including

commercial documentation)

The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims

arising from third parties, whatever nature or whatever relationship to the opposing party.

Enraf-Nonius strives to achieve the highest possible accuracy in the creation of both its products as well

as its documentation; however, no translation is perfect. Translations of any materials are based on the

Dutch language. If any questions arise related to the accuracy of the information contained in the

translated versions, only the Dutch version of the document is binding. Any discrepancies or differences

created in the translation are not binding and have no legal effect for compliance or enforcement

purposes

CAUTION:

No modification of this device is allowed.

2 Intended Use

The Endolaser 422 is a Low Level Laser therapy unit. The light source treatment that generates light of a

single wavelength. LLLT emits no heat, sound, or vibration.

The light energy absorbed into the patient’s tissue, triggers biological changes at a cellular level.

Lasertherapy devices are non-invasive therapeutic active devices, used mainly by physiatrists,

physiotherapists, and pain therapists.

The use of these equipments is reserved, under the supervision and responsibility of an expert in the

problems of the laser radiation, for operators that, by their training, provide assurance of proper use and

safe for the patient.

In fact, the operator must be appropriately qualified and he carefully studied the contents of the user

manual in order to use the device; or, he must operate under the supervision of a health professional

adequately qualified to use the machine, able to understand the benefits and the limits of therapy and to

work in conditions of safety for the person undergoing treatment.

Such equipment can be used in hospital environment outpatient, nevertheless, it is important to know that

the user follow the medical instructions to use the equipment or that he follow the indications present in

the user’s manual.

WARNINGS:

• CLASS A device (EN 61000-3-2) suitable for use in all establishments other than domestic and

those directly connected to the public low-voltage power supply network that supplies buildings

used for domestic purposes.

• The divice or system must not be used near other equipment and, if it is necessary to use it near

other equipment, the medical electrical equipment must be observed to check normal operation in

the configuration in which it is used.

• If the electro-medical device, interacting with another device, causes or receives detectable

interferences, the user is invited to limit the interference by adopting one or more of the following

measures:

o Change the position and the orientation of the receiving device;

o Increase the distance between the devices;

o Connect the equipment to a socket of a circuit different from or to devices that cause

interference;

o Contact the manufacturer or local technician for assistance.

• Portable and mobile radiocommunication devices can affect the operation of the device.

2.1 Indications

• Increased ATP production by the mitochondria and increased oxygen consumption on the cellular

level, which results in muscle relaxation.

• Increased serotonin and increased endorphins

• Increased anti-inflammatory effects through reduction of prostaglandin synthesis

• Improved blood circulation to skin in cases like neuralgia and diabetes mellitus

• Decreases permeability of the membrane of the nerve cells for Na/K causing hyper-polarization

• Increased lymphatic flow and decreased oedema

• Healing wounds

2.2 Contra-indications

1. Irradiation directly into the eyes: Class 3B laser is potentially harmful to the retina although damage

to the retina is extremely unlikely. The special safety glasses (supplied) must however be used by

both the patient and operator.

2. Pregnancy: laser is not recommended for use on a gravid uterus. It may however be used in

the case of pregnant women as long as precautions are taken so as to avoid radiating on the

abdomen

3. Neoplasy: do not use the laser on primary or secondary non diagnosed lesions. Laser treatment

may be performed in the terminal stages of the illness to alleviate pain make sure that treatment

is carried out with the full consent of the patient.

4. Thyroid: laser must under no circumstances be used on the thyroid gland.

5. Haemorrhage: the vessel dilation due to the use of laser may worsen haemorrhage.

6. Suppressive immune therapy: laser-therapy is not recommended in patients who are undergoing

such medical treatment.

7. Treatment on the simpatico gangues, on the vagus nerve or on the cardiac region in patients

with heart disease: laser therapy may significantly alter neural function and is therefore not

recommended on patients with cardiac disease.

CAUTION:

 Photosensitive reactions: in some cases, patients who assume well-known drugs photosensitive

reactions may occur due to such pharmaceuticals. It is not yet clear why the combination of laser

treatment and such drugs causes 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, pacemakers DO NOT constitute any contra-indications for the use

of laser. This can be used safely on patients with metal or plastic implants, on stitches and on

patients with pacemakers.

3 In General

Enraf-Nonius BV. develops and manufactures equipment and accessories according to the highest

standards of quality making use of the latest technology and fully adhering to current directives and

norms.

Particular attention has been paid to the design, easy operation, function and safety of the equipment and

the final result is this modern, compact unit, which offers an extremely logical operative sequence

supported by a clearly legible display. A wide range of therapeutic applications guaranteed patient and

therapist safety make, the Endolaser 422 of the highest quality.

4 Installation

4.1 Unpacking

Endolaser equipment is specially packaged for transport in a single pack complete with filling which has

been specifically studied 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.

Endolaser 422 Type 1 or 2.

WARNINGS:

The manufacturer is held responsible for the fundamental safety, reliability and performance of the device

only if:

• The electrical system of the premises complies with the appropriate regulations;

• The device is used in accordance with the instructions for use.

CAUTION:

• The correct position while moving the machine: the apparatus has to be moved exclusively by

gripping it with both hands on the curved profiles of the lid.

• The perfect functionality of the appliance is guaranteed in compliance with the installation and

use regulations indicated, only with original accessories and spare parts.

4.1.1 Standard accessories:

Type 1 Type 2

1422.911 Endolaser 422 – 230VAC 1422.912 Endolaser 422 – 115 VAC

1422.815 Protective goggles 2 pair 1422.815 Protective goggles 2 pair

1422.750 User manual 1422.750 User manual

3444.290 EUR - Power cord 3444.672 UL-CSA - Power cord

1422.830 Interlock connector 1422.830 Interlock connector

Laserprobe holder Laserprobe holder

2x spare fuses 2x spare fuses

The main features that the operator / patient safety glasses must possess are the following:

− Wavelength: 808-905 nm

− Gradation number: 5

− Optical class: 1

− Optical density (λ = 808 nm): 3.523

− Optical density (λ = 905nm): 4.456

− CE marking

4.1.2 Optional accessories:

Model

Average Power

Peak Power

1422.816

Laserprobe with one diode laser 905nm (LP025) 25 mW 25 W

1422.817

Laserprobe with one diode laser 905nm (LP100) 100 mW 100 W

1422.818

Laserprobe with one diode laser 808nm (LP500) 500 mW 500 mW

1422.819

Clusterprobe with four diode laser 905nm (CP400) 4 x 100 mW 4 x 100 W

Check the contents of the package and should any of the items be missing then contact your local

authorized Enraf-Nonius BV. dealer.

Save the original box and all the packing materials in case of return to manufacturer or your dealer.

WARNINGS:

• Do not use accessories other than the original ones supplied: these could damage the machine

and void the warranty claim. In the event that problems or installation problems occur, contact the

Enraf Nonius technical assistance service.

• The use of accessories, transducers and cables, other than those specified or supplied by Enraf

Nonius, could lead to higher electromagnetic emissions or a decrease in the level of

electromagnetic immunity of the appliance, with consequent incorrect operation.

4.1.3 Environmental conditions for normal use

Installation of the equipment is fast and simple and does not require any particular attention. The

following environmental conditions are ideal when installing the unit:

Room temperature : 10°C to 40°C

Humidity level : 10% to 80% non condensing

Atmospheric pressure : 500 to 1060 hPa

Avoid direct exposure to sunlight, chemical products and vibrations.

CAUTION:

In the indicated temperature range, during normal use, laser probe can reach the following temperatures:

• LP100 49.9 °

• LP025 50.3 ° C

• CP400 61.9 ° C

• LP500 64.7 ° C

Without increase the patient's health at risk.

CAUTION:

• Do not use Endolaser equipment wherever there is a risk of either the external or internal parts of

the unit becoming wet.

• It is absolutely forbidden to use the device in the presence of flammable anesthetic mixtures and

oxygen rich environments. In case of non-compliance with the information provided, EME srl will

not be held responsible for any accidents.

4.2 Electrical Connection

The power entry module can be found on the back of the unit and consists of a three-pole socket for the

cord set, an extractible fuse box with two fuses (see Technical specifications) and the main switch.

Insert correctly the three-pole plug of the cord set into the power entry module.

WARNINGS:

• Before plugging the cord set into the mains, check to make sure the equipment has not

undergone any damage during transport and make sure the voltage corresponds to that of the

unit (see the rating plate on the side of the unit).

• For safety purposes the cord set is provided with an earthed plug.

• Make sure that power supply socket has been earthed.

• The equipment must only be connected to the mains which are in conformity with EEC standard

directives, to avoid the risk of electric shock, in fact, this appliance must always be connected to

power supply networks with protective earth.

• When using an extension lead, make sure that this has been earthed

• Failure to comply with the above instructions may lead to dangerous electrical discharge causing

hazard to persons and the machine function.

CAUTION:

• If an extension lead is used with Endolaser together with other equipment, make sure that the

total ampere rating of all the devices in question does not exceed that which is consented by the

cable and does not in any case exceed 15A.

• Once you have checked that installation and assembly have been carried out according to

instructions provided up to this point in the manual, switch on the machine making sure that the

display screen is turned on correctly.

4.3 Remote Interlock connector

The unit is provided with a safety key (interlock) which consists of a DIN plug on to be inserted at the

back of the unit. The machine WILL NOT WORK without this this without the interlock security key. The

plug allows the operator to connect this with the local interlock switch. (Use for the interlock switch a 2-

way micro switch this is normally turned off.)

The safety key or interlock switch interrupts the invisible laser emission only and not the Led power

supply.

WARNINGS:

• Before starting the equipment, make sure that the INTERLOCK key that allows it to start is

inserted.

CAUTION:

• If you want to install the external 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.

If an external safety interlock circuit is required, a minimum diameter of 0.6mm, 20m max, with a shield

connected to the ground must be provided.

On the safety circuit side, a microswitch with one normally closed path must be provided.

This circuit is an external safety device: it allows to interrupt laser therapy treatments if there is a door

opening inside the room where the treatment is delivered.

In the case where the laser-therapy treatment delivery room has only one door, the scheme of interest is

as follows:

Se invece la stanza sede dell’erogazione del trattamento di laser-terapia dispone di più porte, lo schema

di interesse è il seguente:

5 Operating Instructions

The Endolaser 422 unit has a well-engineered control panel ideal for use in the specific field of application

for which it was designed.

All working parameters are handled and controlled in real time by a sophisticated microprocessor

electronic circuit which clearly displays its functions accompanied by acoustic signalling.

5.1 Operation Information

This chapter provides important information and instructions on how to make correct use of the Endolaser

equipment for laser therapy.

All the control functions and the machine itself are handled and co-ordinated by a microprocessor: apart

from making available pre-memorized programmes for application the microprocessor ensures that the

machine can be personalized and operate in a highly safe and efficient manner. Interfacing allows for the

operator to dialogue with the apparatus by means of large, clear graphic backlit liquid crystal display

screen (LCD): all the information for operation required by the operator, work status during operation and

any eventual errors are visualized. The following paragraphs illustrate the procedures to be carried out

and the technical specifications of the Endolaser. They also deal with the different options available from

the selection of pre-programmed protocols for use in specific treatments as well as how to determine the

correct working parameters for “personalized” application.

5.2 Operation controls front panel

The front panel of the unit, which comprises the controls and signals, can be seen in fig. 1 with

corresponding key.

[1] Selection button 1

[2] Selection button 2

[3] Selection button 3

[4] Selection button 4

[5] Start – Pause button

[6] Stop button

[7] Laser tester

[8] Output connector for channel 1

[9] Output connector fro channel 2

[10] Confirmation button

[11] Central controller

In order to navigate the software you need to use:

• the central knob, which can rotate both clockwise and anticlockwise, and allows you to move the

selection to the desired option;

• the buttons on the side of the display (from 1 to 6) that allow you to confirm an option, start or

stop a treatment.

CAUTION:

Use of controls or adjustments or performance of procedures other than those specified herein may result

in hazardous radiation exposure.

5.3 Operation controls rear panel

The rear panel contains the power entry module which consists of the main switch, the fuse box and the

socket for the cord set.

[12] Connection power cord

[13] On / off switch

[14] Fuse box

[15] Interlock connector

5.4 Turn on the apparatus

CAUTION:

Use of controls or adjustments or performance of procedures other than those specified herein may result

in hazardous radiation exposure.

• Plug the power cord on socket [12]

• Connect the safety or interlock connector to socket [15]

• Use switch [13] to turn the apparatus on.

• The unit starts-up with the logo on the display. After a self test the code screen is displayed.

The following will appear on the screen:

• Insert de secret code to unlock the unit by

pushing the selection buttons 1-4 in the right

order.

• The current code is 1234

• The unit will display the main menu

Enter

Code

****

CAUTION:

• Do not leave the device switched on unattended, always switch off at the end of use to avoid use

by unauthorized personnel.

• It is strongly advised not to keep the machine switched on in a start state without the handpiece

being used, as it may overheat.

5.5 Main Menu

• Select “Select Program” to start working via

protocols, see 6.8.3

• Select “Create Program” to store personal

settings, see 6.8.4

• Select “Settings” to enter the settings menu,

see 6.7

• Select “Manual Operation” to set all parameters

manually, see 6.8.2.1

Select Program

Create Program

Settings



Manual Operation

5.6 Default setting

5.6.1 Set UP default settings

This enables the basic settings to be memorized and stored within the machine memory and will

automatically be displayed each time the machine is turned on.

• Select “Settings” with the push button [3]

• Choose Display function with the central

controller [11]

• Press the confirmation button [7] to confirm

choice.

• Press Return to return to the main menu







Return

Settings



Display

Various

Language

5.6.2 Select Language

• Select “Settings” with the push button [3]

• Choose Language function with the central

controller [11]

• Press the confirmation button [10] to confirm

choice.

• Press Return to return to the main menu







Return

Settings

Display

Various



Language

• Select the desired language with the central

controller [11]

• Press the confirmation button [10] to activate

the selection

• Press the save button [1] to save the selection

• Press the cancel button to interrupt the

procedure







Save







Cancel

Language

Italiano



English

Français

Español

Deutsch

Nederlands

5.6.2.1 Display background

• Choose the Negative to change the display

background with the central controller [11]

• Press the confirmation button [7] to activate

choice

• Press save button [1] to save the setting

• Press cancel button [2] to cancel the change







Save







Cancel

Display







 Negative

Contrast: 15

Brightness: 15

5.6.2.2 Changing Contrast

• Choose Contrast with the central controller

[11]

• Press the confirmation button [7] to activate

choice

• Use the central controller [11] to adjust the

setting

• Press save button [1] to save the setting

• Press cancel button [2] to cancel the change







Save







Cancel

Display





 Negative



Contrast: 15

Brightness: 15

5.6.2.3 Changing Brightness

• Choose Brightness with the central controller

[11]

• Press the confirmation button [7] to activate

choice

• Use the central controller [11] to adjust the

setting

• Press Save button [1] to save the setting

• Press Cancel button [2] to cancel the change







Save







Cancel

Display





 Negative

Contrast: 15



Brightness: 15

5.6.3 Various settings

• Select “Settings” with the push button [3]

( 6 - fig.1)

• Choose Various function with the central

controller [11]

• Press the confirmation button [7] to confirm

choice.

• Press Return to return to the main menu







Return

Settings

Display



Various

Language

• Select Buzzer to turn it on or off

• Select Clear memory to clear the complete

memorised personal protocols

• Select Probe 1 to set the default probe used

on channel 1

• Select Probe 2 to set the default probe used

on channel 2

• Select Energy for the output energy in Joule.

• Select Fluency for the output energy in Joule

/cm







Save







Cancel

Various







 Buzzer on

Clear Memory

Probe 1: LP025

Probe 2: CP400





 Energy





 Fluency

5.7 Basic Operation

5.7.1 Manual Operation

This allows you to rapidly use the therapy parameters.

Use the option “Manual Operation” to define your personal parameters settings for the Laserprobe.

To select the output channel push the button [1]

Every push on the button [1] will change the channel.

In the middle of the screen your selected channel will be shown as follows:

Channel < 1 >

for channel 1 and

Channel < 2 >

for channel 2

The last program used for each output channel is indicated on the page.

Obviously, if a channel is currently being used it is not available for a new program until it has terminated.

Any of the parameters can only be changed before starting therapy however, modified programs cannot

be memorized.

• Push the button [4] Manual Operation

• Select a channel with button [1]

• Select a parameter with the central controller [11]

• Confirm the selection with confirmation button [10]

• Adjust the value with the central controller [11]

• Confirm the setting by pushing the confirmation

button [10]

• To start the emission push the start button [5] the

Stop symbol  change to running 

• To interrupt the treatment push the stop button [6]

once. Running symbol  change to pause

• To Stop the treatment push the stop button [6]

again when the pause symbol is active

• Push Return button [2] to return to the main menu







Select Channel 2







Return

Personalised

Channel < 1 >



Freq.: 5000Hz

Time: 00:20 s

Dosage: 6 J/ cm²

Select Program











LP025 LP100

00:00 00:00

0,1 J/cm²







12 mWatt

NOTE: The Endolaser 422 has two independent output channels. On each channel you can set

parameters. Repeat the operation as described above with the other channel.

CAUTION:

• 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, EME srl 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.

• The laser radiation coming out of the device is dangerous: always use the appropriate

protective glasses. Always avoid eye exposure to direct or diffuse radiation.

• It is advisable not to start the treatment delivery if the machine does not show up in perfect

mechanical conditions or if there are no laser emission characteristics that conform to the

purpose (see the table of technical characteristics).

• NEVER RETURN THE HANDPIECE TO THE PARTS OF THE SENSITIVE BODY TO THE

LASER RAYS, FOR EXAMPLE OF THE EYES.

• DO NOT LOOK AT THE RADIUS ISSUED BY THE HANDPIECE OR THE DIRECT RETURN

WHICH IS REFLECTED DURING THE TREATMENT.

5.7.2 Parameter Adjusting

By rotating the central controller the entire range of alphanumerical characters can be chosen.

The percentage by which the “Pulsed mode” is defined represents the percentage of time the cycle is in

action as opposed to the length of time of the entire working cycle.

Therefore 50% attributes the same time length to the action phase and to the following interval.

Pulsed: 100% is equal to the continuous mode.

5.7.2.1 Select Program via Manual Operation

The memorized programs available have been specially created by professional and expert operators

after years of experience in the field.

A list of all available programs can be found in Appendix B.

• When you are in the Manual Operation you have also access to the pre-programmed protocols.

• Select a channel with button [1]

• Select “Program” with the central controller [11] and accept the selection with confirmation button

[10].

• Select from the list the desired protocol with the central controller [11] and confirm the selection

with confirmation button [10]

• Start the emission with de start button [5]

NOTE: The Endolaser 422 has two independent output channels. On each channel you can set

parameters or load a pre-programmed protocol. Repeat the operation as described above with the other

channel.

5.7.3 Select Program

The memorized programs available have been specially created by professional and expert operators

after years of experience in the field.

A list of all available programs can be found in Appendix B.

• Select with push button [1] Select Program in the

main menu.

• Select a program from the list with the central

controller [11]

• Confirm the selection with the confirmation button

[10]

• The program will be loaded on both channels

User Programs







Return

Select Program

Acne



Arthritis

Cervical Syndr.1

Cervical Syndr.2

Cervical Syndr.3

Cervical arth.1

Cervical arth.2

Cervical arth.3

Hypertro. Scars

5.7.3.1 Load a programme on channel 2

• Select Channel 2 with button [1]

• Go to Select Program with the central controller [11]

• Confirm the selection with confirmation button [10]

• Select a program from the list with the central

controller [11]

• Confirm the selection with the confirmation button

[10]

• To start the emission push the start button [5] the

Stop symbol  change to running 

• To interrupt the treatment push the stop button [6]

once. Running symbol  change to pause 

• To Stop the treatment push the stop button [6]

again when the pause symbol is active

• Push Return button [2] to return to the main menu







Select Channel 2







Return

Arthritis

Channel < 1 >



Freq.: 5000Hz

Time: 00:20 s

Dosage: 6 J/ cm²

Select Program











MLA-1 MLA-3

00:00 00:00

0,1 J/cm²







12 mWatt

CAUTION:

• 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, EME srl 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.

• The laser radiation coming out of the device is dangerous: always use the appropriate

protective glasses. Always avoid eye exposure to direct or diffuse radiation.

• It is advisable not to start the treatment delivery if the machine does not show up in perfect

mechanical conditions or if there are no laser emission characteristics that conform to the

purpose (see the table of technical characteristics).

• NEVER RETURN THE HANDPIECE TO THE PARTS OF THE SENSITIVE BODY TO THE

LASER RAYS, FOR EXAMPLE OF THE EYES.

• DO NOT LOOK AT THE RADIUS ISSUED BY THE HANDPIECE OR THE DIRECT RETURN

WHICH IS REFLECTED DURING THE TREATMENT.

5.7.4 Create programs

• Select “Create program” in the main menu by

pressing button [2]

• Select a position in the list with the central controller

[11]

• Confirm the selection with the confirmation button

[10]

• Adjust the parameters







Return

Select Program



01………….

02………….

03………….

04………….

05………….

06………….

07………….

08………….

09…………..

10…………...

To change the frequency

• Select Freq.: with the central controller. Accept the

setting with the confirmation button [10] and adjust

the value with the central controller [11] Confirm with

the confirmation button [10]

Repeat the procedure for:

• Pulse mode

• Time

• Program name

o Select a position on the line

o Confirm the position with button [10]

o Change the characters (number and

characters can be changed)

o Confirm with button [10]

o Select another position

o Press OK button [1] when the name is

complete







Create Program



Freq.: 5500Hz

Time: 00:20 s

Dosage: 6 J/ cm²

01………….

• Push the Save button [1] to store the setting from

PROGRAM 1 in the memory.

• The list displays the names of the created programs.







Save







Return

• There are 50 positions available

NOTE

• It’s possible to overwrite stored programs.

• Go to Settings to clear the complete memory. Only

the created programs will be deleted.

Create Program

Freq.: 6500Hz

Time: 00:20 s

Dosage: 6 J/ cm²



PROGRAM 1

5.7.5 Load the created programs

• Select with push button [1] Select Program in the

main menu.

• Select “User Programs” with the selection button [1]

• Select a program in the list with the central controller

[11]

• Confirm the selection with the confirmation button [10]

• The program will be loaded on both channels

User Programs







Return

Select Program

01…………..



02…………..

03…………..

04…………..

05…………..

Protocol-05

06………….

07………….

5.8 Laser test

• Turn the unit on and adjust the parameters

• Press button [5] to start the laser emission

• Hold the laser probe above the laser tester [7]

• The information pop-up screen informs you that emission is present.

• After a short period the information disappears.

5.9 Therapy application

Once you have pressed START, the TIMER will set off and this can be seen by the timer symbol and the

arrow () in correspondence with the channel (a square  indicates that the channel is not active).

For example, we can see that channel 1 is not active while channel 2 is performing a program.

The frame around Channel 2 indicates that the visualized program is related to channel 2.

Press the corresponding function key in order to see the program which has been loaded in the other

channel.

Countdown and emission continue until:

• The set time has elapsed: the system will then emit an acoustic signal.

• The STOP button has been pressed once: the cycle being emitted will be put on Pause , push

STOP again to end the treatment.

The machine emits a BEEP at 3 second intervals to indicate that emission is in progress during therapy

application.

As previously mentioned, the Endolaser is an IR diode laser band generator, designed and produced

according to national and international safety standards (see Appendix) and is classified as CLASS III B

laser equipment. However, it must be remembered that caution is required when operating these

machines to reduce risks (considered as quite low given the power specifications related to IR diode

radiation) in association with a light source laser which is intrinsically monochromatic, directional,

coherent and brilliant.

CAUTION:

The laser radiation emitted by the machine is intrinsically dangerous: use the special protective goggles

at all times; do not look at the beam either with naked, unprotected eyes or with optical instruments; avoid

unprotected exposure to the beam; avoid exposure of the eyes to direct or diffused radiation.

Direct exposure for a fraction of a second to laser radiation certainly does not constitute problems

however, prolonged exposure creates harmful effects. Any damage is in direct relation to the power of the

emitter.

6 Maintenance and Troubleshooting

6.1 User maintenance

The Endolaser machine for laser therapy does not require any particular maintenance except for

cleaning.

WARNING:

• Before carrying out any maintenance or cleaning procedures on the equipment, MAKE SURE TO

TURN OFF the unit by the switch on the rear panel and disconnect it from the mains.

• In order to guarantee the operation of the machine in conditions of absolute safety for the patient,

it is advisable to subject the machine to a periodical check cycle (at least 2 years) to be

performed by an authorized Enraf Nonius technician.

• For optimal use of the equipment and to guarantee its maximum performance, it is recommended

that the maintenance actions are carried out correctly and in the recommended times.

6.1.1 Cleaning the apparatus

When cleaning the outer part of the equipment, make sure to use a soft, clean cloth dampened with

lukewarm water and a non-abrasive liquid household cleaner. (No abrasive, no alcohol content solutions)

The front panel can be cleaned in the same way.

CAUTIONS:

• The cleaning and relative disinfection (probe and equipment) must be carried out in a systematic

way before the execution of the therapeutic treatment to be submitted to the patient.

• When cleaning the outer part of the equipment, do not use detergents, acid solutions, abrasive or

aggressive solutions or inflammable substances.

• Use of any of the above mentioned substances or improper use of the accessories will cause

irreparable damage to the equipment and the guarantee will be no longer valid. Do not spray or

pour liquid on the external parts of the equipment, or into the air holes on the casing.

• Do not immerse the unit into water.

• After cleaning the exterior part of the equipment, make sure to dry it perfectly before turning on

the unit.

• The unit must under no circumstances be opened or dismantled in order to clean or check inner

parts – Endolaser equipment does not require cleaning of inner parts and in all cases, only

specialized technicians of Enraf-Nonius BV. should carry out such operations.

• Check the integrity of the cord set and the cables connecting the Laserprobe at frequent intervals:

these should never present damage or wear and tear

6.1.2 Cleaning laserprobes

To prevent corrosion, clean and dry the contact surface immediately after use. Make sure that nothing

remains on the laserprobes surface. We further recommend cleaning the applicator and cable daily, using

lukewarm water. The laserprobe surface can be disinfected using a cloth moistened with a 70% alcohol

solution. Check the laserprobe and cable regularly for damage.

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Enraf-Nonius Endolaser 422 User manual

Enraf-Nonius Endolaser 422 User manual

Enraf-Nonius Endolaser 422 User manual

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