DolorClast High Power Laser FT-245 Instructions for Use

DOLORCLAST® HIGH POWER LASER ENGLISH...3 ITALIANO...29 ESPAÑOL...55 PORTUGUÊS...81

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ENGLISH

ENGLISH

Read carefully before use!

Please take into account that the English version of this manual is the source text from which all translations derive. In case of any discrepancy, the binding version is the English text. These operating instructions serve to ensure the correct installation and use of this product. Always keep these instructions close at hand. Please read these instructions for use carefully as they explain important details and procedures. Please pay particular attention to the safety precautions. Any serious incidents that occur in relation to the product must be reported to the manufacture and relevant authority. For any technical issues or complaints regarding the use of this product, please contact your local customer service representative. To avoid injury to people or damage to property, please follow the instructions contained in this manual. They are labelled as follows: Warning: Risk of serious injury to patient or user Caution: Risk of injury to patient or user. Risk of damage to the product or the environment. Notes: Useful additional information and recommendations

The mechanism of action of the FT-245 is based on the biostimulation tissues, in which it acts through the deep release of electromagnetic energy in the form of infrared laser light.

ITALIANO

General information

This product is a laser therapy system for outpatient physiotherapy applications aimed at treating musculoeskeletal affections.

Patient population  his device is intended only for patients older than T 8 years of age. Fields of application Regardless of whether the cause is due to direct trauma, functional overload, and/or with an acute or chronic course, there are three pathogenetic events that have a common denominator: 1. Acute or chronic inflammation Inflammatory processes are activated at the injured site, starting with humoral processes, which are rapidly followed by cellular processes that lead to the release of substances (cytokines, lymphokines, prostaglandins, etc.) that have a direct or indirect harmful action and stimulate macrophage and lymphocyte activation. The immediate effect is stasis of the microcirculation, with increased vessel permeability and tissue edema with further stasis of metabolites causing pain and heat. 2. Changes in the micro- and/or macrocirculation When inflammation persists, and depending on the extent and severity of the phenomenon, the circulation suffers changes that can also affect larger vessels, with changes in flow and venous-lymphatic drainage. 3. Fiber and connective tissue injuries The resulting tissue damage, in addition to inflammatory damage, in injuries to fibers (muscular, tendinous, nervous, etc.) and connective tissues caused by direct or indirect action of the harmful pathogen. This can be represented by a trauma or rapid-onset acute condition, or by a functional overload with a slower and less obvious course.

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ESPAÑOL

We wish you every success!

Product description and intended use

PORTUGUÊS

We would be pleased to answer any of your questions and every your suggestions are welcome . Of course, we will provide support in case of technical problems. If should you need, do not hesitate to contact your EMS-approved service center or dealer directly.

Acute traumatic disease This refers to the clinical and organic pictures as a whole, in which inflammatory aspects and acute injuries prevail over the vascular and degenerative components typical of chronicity. From an etiological point of view, the traumatic event is the basis for this group of conditions. Muscular and capsuloligamentous structures are the most affected, with where tissue lesions caused by stretching, compression, or crushing, may be observed, depending on the type of action (direct or indirect) of the harmful agent. Anatomopathological changes observed in muscles range from fiber elongation with perifibrillar edema, to complete rupture with hematoma or blood effusion, whereas tendinous and capsuloligamentous structures are most often affected by acute inflammation with intraand peritendinous effusion and stretching of the fibers. Functional overload conditions

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Peritendinitis and tenosynovitis associated with tendinopathy

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Subcutaneous ruptures; epiphenomenon of a degenerative condition of the tendon belly

The etiopathogenic considerations made in regard to tendons also apply to joint cartilage. Indeed, functional stress can lead to the onset of an injury which, due to the softening, fissuring, fibrillation and superficial erosion phases, can lead to the exposure of the subchondral bone, thereby causing an anatomopathological picture similar to that of osteoarthritis. The medical device FT-245 can be used in two different modes: - Indications, in relation to the area of the body, the pathology to be treated is indicated; -Actions, operating mode chosen based on the desired effect. The pathologies and possible actions are listed below: List of indications •

Rotator cuff tendinopathy

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Glenohumeral arthritis

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Acromioclavicular arthritis

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Proximal biceps tendinopathy

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Subacromial-subdeltoid bursitis

The injuries caused by functional overload and the relative clinical manifestations can appear in any part of the locomotor system, but the tendons (and their appendages) and joint cartilages are those most affected. Repetitive and persistent microtraumatic action does not allow adequate repair of the injuries suffered by tendon tissues because the tendon tissues are in constant use.

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Epicondylitis

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Arthropathy

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Bursitis

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Medial epicondylitis

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Flexor tenosynovitis

The tendon’s initial response to irritation generally involves the onset of an acute inflammatory picture, which evolves towards tissue degeneration and chronic inflammation conditions if the trigger factor is not resolved.

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Extensor tenosynovitis

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De Quervain’s tenosynovitis

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Dupuytren’s contracture

Of the numerous classifications available, the one by Perugia et al. best expresses the anatomopathological essence of the injury. It states as follows:

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Carpal tunnel

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Rhizarthrosis

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Wrist arthritis

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Cervical degenerative disc disease

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Lumbar degenerative disc disease

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Thoracic degenerative disc disease

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Intervertebral arthritis of the neck

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Intervertebral arthritis of the lower back

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Intervertebral arthritis of the upper back

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Trochanteric bursitis

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Hamstring enthesopathy

The most reliable data in the literature agree that approximately 50% of conditions affecting bones, muscles and joints are caused by overload, meaning the harmful effect of irritative stress, repeated in cycles for prolonged periods, or with high intensity affecting several areas and tissues.

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Peritendinitis; with inflammation of the peritenon, subdivided into serous exudative forms and chronic adherence forms

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Tendinopathy; with degenerative and metaplastic processes of the tendon tissue

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Hypertrophic-exudative and stenosing tenosynovitis

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Insertional tendinopathies; areas of degeneration and metaplasia are visible at the osteotendinous junction

Anterior chronic arthropathy

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Lateral chronic arthropathy

Use of this product is contraindicated in patients with any of the following conditions:

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Pes anserine bursitis

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Patellar tendinopathy

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Medial tibiofemoral osteoarthritis

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Lateral tibiofemoral osteoarthritis

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Patellofemoral arthritis

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Baker’s cyst

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Achilles tendinitis

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Retrocalcaneal bursitis

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Osteoarthritis of the lateral tibiotarsal joint

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Osteoarthritis of the medial tibiotarsal joint

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Plantar fasciitis

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Metatarsalgia

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Metatarsophalangeal joint arthritis

List of actions •

Anti-inflammatory

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Soft tissue anti-edema

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Bone marrow edema

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Hypersensitive patient

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Muscle relaxant

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Trigger points

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Analgesic

Once the indication or action has been selected, prior to emission all of the preset parameters for the pathology to be treated will appear on the display.

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State of pregnancy;

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An implanted electrical stimulator (e.g. pacemaker);

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In the treatment of areas affected by neoplasia;

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Patients undergoing chemotherapy;

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Patients suffering from epilepsy;

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Patients being treated with photosensitive drugs;

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Patients with cochlear implants;

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Patients with febrile symptoms;

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Avoid irradiation of the eyes, endocrine glands, ears and periauricular area;

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Avoid irradiation of compromised skin;

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Avoid irradiation of the tattooed areas;

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Avoid irradiation of areas with sensory loss;

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Avoid irradiation of freckles.

Potential complications Potential complications associated with the application of laser energy include: •

A dark complexion and/or the presence of tattoos may result in increased radiation absorption by the epidermis. This may cause side effects on the skin, such as reddening or blistering. We recommend monitoring treatment closely and using the ‘Hypersensitive patient’ program.

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The skin may react to the heat depending on individual photosensitivity. Monitor treatment closely and if reddening or blistering occurs, use the ‘Hypersensitive patient’ program.

This medical device must not be used for surgical or any invasive applications. Intended user This medical device must only be operated by an appropriately qualified physician with experience in physiotherapy or by an appropriately qualified health professional. The user must be trained in the use of the device. The user should be familiar with all safety precautions and warnings, operating procedures and maintenance instructions given in this manual.

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ENGLISH

•

ITALIANO

Contraindications

ESPAÑOL

Adductor strain (pubalgia)

PORTUGUÊS

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CONTENTS 1. WARNING���������������������������������������������������� 7 2. COMPONENTS������������������������������������������� 8 3. INSTALLATION����������������������������������������� 10 3.1. INSTALLATION AND CONNECTIONS������������ 10 3.2. REMOTE INTERLOCK������������������������������������ 10

4. START-UP�������������������������������������������������� 11 4.1. INDICATIONS�������������������������������������������������� 11 4.2. ACTIONS��������������������������������������������������������� 13 4.3. CUSTOM���������������������������������������������������������� 14 4.4. SETTINGS������������������������������������������������������� 14 4.5. HISTORY��������������������������������������������������������� 15

5. CLEANING������������������������������������������������ 16 5.1. GENERAL RULES FOR CLEANING��������������� 16 5.2. METHOD OF CLEANING�������������������������������� 16

6. PRODUCT MAINTENANCE���������������������� 16 6.1. LENS REPLACEMENT������������������������������������ 16 6.2. PERIODIC MAINTENANCE����������������������������� 16

7. PRODUCT DISPOSAL������������������������������ 17 8. LIMITS OF LIABILITY������������������������������� 17 9. TECHNICAL SUPPORT AND WARRANTY���������������������������������������������� 18 10. TROUBLESHOOTING������������������������������� 19 10.1. REMOTE INTERLOCK������������������������������������ 19 10.2. SYSTEM WARNINGS�������������������������������������� 19 10.3. TROUBLESHOOTING������������������������������������� 20 10.4. CHECKING AND REPLACING FUSES����������� 20

11. ELECTROMAGNETIC COMPATIBILITY�� 21 11.1. EMC WARNINGS��������������������������������������������� 21

12. TECHNICAL SPECIFICATIONS���������������� 23 12.1. ESSENTIAL PERFORMANCE������������������������� 25

13. SYMBOLS������������������������������������������������� 26

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understand and follow the recommendations contained in the instruction manual. Failure to follow the instructions for use may result in serious injury or harm to the patient or user. This product can only be used by qualified personnel and for the intended use and the applications described in this manual. If the product is used in combination with other instruments, please refer to their instruction manuals. Do not use this product in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such as ether or alcohol), as explosion may occur. Keep the operating area free from flammable objects such as paper, cotton pads, plastics, wood or similar. Use of the laser causes the release of endogenous gases. Caution: fumes and/or vapors caused by the laser may contain particles of living tissue. Before using the product, inspect for any damage. Do not use if the product is damaged. Only use original EMS replacement parts and accessories. Do not modify or repair the product yourself. Please contact an EMS-approved service center. The electrical system that powers the medical  device must comply with all applicable legislation. Check that the power outlet for the premises has an effective ground connection. When the mains power switch is in the “0” position, the product is disconnected from the electric power source. Remove the ignition key when the system is not in use. The environment in which the machine operates must be indoors and appropriately set up, with no reflective surfaces in order to avoid reflections that may damage the eyes. The room temperature must be between +15°C and +35°C and the relative humidity must be between 45% and 60% with no condensation. The laser safety label must be applied to all access doors to the operational area. When the equipment is in operation, access to the operating area must be limited to authorized personnel only, and use of the safety goggles provided is compulsory for both the user and the patient. Avoiding looking directly at the aperture of the handpiece during delivery.

 ending with too tight a bending radius and/or B pulling on the optical fiber containment jacket can damage the internal fibers and/or cause injury to the patient or laser operator. Do not use the machine if the upper panel is open or not closed correctly. Use of extension cables, multi-socket extension leads, adaptors and/or resistors is not permitted. When the machine is turned on for the first time, particularly after having been transported in temperatures below 10°C/50°F, the device must be left in STAND-BY mode for at least 15 minutes before activating the laser emission. The FT-245 laser is equipped with a forced-air cooling system with internal fans located near to the laser diodes. Never obstruct the slots on the back of the machine, as this may result in internal overheating with subsequent damage to the device. Eye and skin exposure: The laser beam emitted by the FT-245 can cause sight loss. The device functions at a visible (red guide light) and invisible (IR light) wavelength. Any energy transmitted by laser devices that enters the eyes will be focused directly onto the retina. Direct absorption of laser energy by the retina may cause temporary blurred vision, retina injury, long-term scotoma and longterm photophobia. In any event, there is a risk of: - Direct laser radiation - Reflected laser radiation - Diffuse laser radiation Anyone in the area in which the FT-245 is  operating or undergoing maintenance must wear safety glasses with DIR LB6 protection, in line with directive EN207.  ll individuals present in the laser’s operating area A must wear all protective equipment. Always check the integrity and condition of safety glasses. Before putting on the safety glasses, check that the safety lenses are in good condition.

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ENGLISH ITALIANO

Before using this product, please carefully read,

ESPAÑOL

EMS and the distributor of this product accept no liability for direct or consequential injury or damage resulting from improper use, arising in particular through the failure to follow the operating instructions, or improper maintenance.

PORTUGUÊS

1. WARNING

2. COMPONENTS 1.1

1.5

1.6

1.7

1.4

1.3

1.2

1.8

1.10

1.9

Figure 1 REF

QTY

1.1

Console (with handpiece)

1

1.2

User manual

1

1.3

Power cord

1

1.4

Spare T1.6AL fuses, 5 x 20 mm

2

1.5

8

DESCRIPTION

Safety glasses (safety rating: DIR LB6 for lasers with λ = 905 nm). Reference standards EN 207:2009, EN 208:2009

2

1.6

Ignition key

2

1.7

Remote interlock connector

1

1.8

Sticker with 2 laser safety labels

1

1.9

DW-1005 cart for laser (optional)

1

1.10

DT-1004 cart arm (optional)

1

ENGLISH ITALIANO 2.2

ESPAÑOL

2.1

2.4

2.3 Figure 2 DESCRIPTION

QTY

2.1

Emergency stop button

1

2.2

Control panel

1

2.3

Fiber containment jacket

1

2.4

Handpiece

1

3.1

3.2

PORTUGUÊS

REF

3.3

Figure 3 REF

DESCRIPTION

QTY

3.1

Remote interlock jack

1

3.2

Power socket

1

3.3

Power switch

1



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3. INSTALLATION Please make sure that you have all the required parts and tools to complete the installation of your device prior to starting work.

4. Insert the remote interlock connector (see section 10.1) into the corresponding jack located on the back of the device (Figure 3).

Use of controls and settings and following procedures other than those specified may result in a risk of explosions and/or uncontrolled laser radiation.

5. Insert the female connector of the power cord into the power socket located on the back of the device (Figure 3).

3.1. INSTALLATION AND CONNECTIONS The FT-245 is delivered in a cardboard box complete with internal packaging to protect the equipment during transport and storage. Before removing the machine from the box, place the container on a hard, flat surface, open the top of the box, remove the top layers of protective packaging and carefully take out the device and all of its accessories. Inside the box, next to the laser are the handpiece and all the accessories. It is the customer’s responsibility to keep the original packaging, which must be used to protect the equipment during transport, in the event it must be returned to EMS for support, or for any other reason. Once the device has been removed from the packaging and placed on a hard, flat surface, proceed as follows: 1. Check that the handpiece is correctly positioned on the handpiece stand. 2. Insert the ignition key provided into the power switch located on the back of the device (Figure 3), keeping it in position O. The ignition key can only be removed in position O. 3. Check that the emergency stop button is not pushed down. If in doubt, turn the red knob counterclockwise, in the direction indicated by the arrows found on it. In case of emergency, the emergency stop button located on the front must be pushed, immediately deactivating the laser device (Figure 2). To restart the device, simply turn the red knob counterclockwise, in the direction indicated by the arrows found on it.

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6. Connect the plug of the power cable to an electrical socket within the installation area. To install the device on the cart (optional), please refer to the assembly documentation attached to the latter.

3.2. REMOTE INTERLOCK The remote interlock connector (Figure 3) is used to interrupt the emission of the laser beam in case of certain events external to the device. Specifically, all access doors in the area where the device is installed must be equipped with micro-interrupters with normally open contacts (which close when the door is fully closed), connected in series to pins 1 and 2 of the corresponding connector; therefore, when one of the doors is opened, an ‘interlock alarm’ situation arises which results in the immediate interruption of any laser emission in progress.  o not apply a voltage to the remote interlock D contacts. The contacts of the remote interlock jack must be closed to enable the system to operate.  he remote interlock connector is supplied with T pins 1 and 2 short-circuited to facilitate set up and initial start-up. It is the customer’s responsibility to remove the jumper and connect them to the protection devices of the room’s entry points.

ENGLISH

4. START-UP

 or treatment in manual mode, the user must F hold the handpiece on the patient’s skin and ‘brush’ the treatment area, moving at a speed of 1 cm/sec. Use of manual programs other than as indicated may cause burns to the patient. 1. Turn on the machine by turning the ignition key to position I (Figure 3). 2. The console automatically performs a series of diagnostic tests that are not shown on the screen. In the event of an error message, please refer to the troubleshooting information provided on the screen or in the troubleshooting section of this manual. 3. The console is ready for use when all diagnostic tests have been completed successfully.

ITALIANO

The ‘Indications’ screen is shown below. The image of a human body will appear on the left with relevant text indicating the treatable areas; the conditions associated with each area will appear on the right.

ESPAÑOL

 ll automatic programs must be used with the A handpiece correctly mounted on the clamp of the arm (optional), which in turn is correctly mounted on the cart (optional). The end of the handpiece (lens end) must be supported within the spacer, taking care to align the groove on the handpiece with the protrusion inside the clamp of the arm. The spacer must be supported on the patient’s skin in the area to be treated (see tutorial photo). Use of automatic programs other than as indicated may cause burns to the patient.

4.1. INDICATIONS

Figure 4 When clicking on the part to be treated or the name, the area is highlighted in blue and the section on the right displays the possible protocols associated with the area (treatable conditions). When clicking on the condition, a page will appear showing a choice between ‘Automatic and Manual’, where the type of treatment must be selected. The ‘home’ icon can be clicked to return to the homepage, or the ‘back’ button returns the user to the previous screen.

4. After this stage, the screen chosen in the ‘Settings’ preferences pages will appear: ‘Indications’ or ‘Actions’. 5. To turn off the machine, turn the ignition key to position O (Figure 3).

Figure 5 Once the selection has been made, the page containing images that illustrate the area to be treated based on the condition chosen will be displayed.

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PORTUGUÊS

 he safety glasses provided for both the user and T the patient must be put on prior to starting laser delivery.

Figure 6

Figure 8

Clicking on the square in the bottom right of the photo will expand it and the user can scroll through the various images shown. If ‘Always show instructions for this treatment’ is unchecked, this page will no longer appear in the future and the user will move directly to the delivery page.

The page indicates the frequency and modulation values, duration of treatment and energy delivered for each individual phase. The ‘Always show’ option returns the user to Figure 6, where they can again tick ‘Always show instructions for this treatment’ if this was unchecked. The ‘Edit’ button, which only appears when the option ‘Custom mode’ is ‘Enabled’, allows the treatment duration in the final phase to be modified, and the new protocol to be saved by selecting a name using the keyboard screen.

Figure 7 Pressing the ‘Back’ option will return the user to Figure 6, and pressing ‘Next’ will move the user to the delivery page.

Figure 9 If the ‘Go to ready’ button shown in Figure 8 is pressed, the device moves on to the ‘Caution’ page, where the user is reminded of the treatment type (automatic or manual) and the use of safety glasses is recommended.

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ENGLISH

At the end of the treatment, the device will emit a longer sound and the screen shown previously in Figure 8 will appear.

The Actions screen shows the type of condition to be treated.

Figure 10

ITALIANO

4.2. ACTIONS

ESPAÑOL

By clicking ‘Next’, the machine moves to ‘Ready’ mode and returns to the delivery page.

Once a selection has been made, the screen shown in Figure 5 will appear and the same steps provided in section 4.1. INDICATIONS are repeated.

Figure 11 Clicking ‘Start treatment’ begins the laser emission.

Figure 12 During treatment, the frequency and modulation values shown change depending on the current active phase, while the total time decreases and the energy delivered increases. The user can stop the emission at any time, or suspend it to then be restarted from the point at which it was stopped.

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PORTUGUÊS

Figure 13

4.3. CUSTOM

4.4. SETTINGS

If the option ‘Custom mode’ is ‘Enabled’, the user can access the ‘Custom’ page, where all protocols changed (Modified) or created (Custom) by the user are saved.

Clicking on the icon in the top right of the homepage brings up the device settings menu.

Figure 14 The creation and modification of existing protocols is the responsibility of the user. Select the custom protocol to modify it further, or to delete it. The ‘Create new’ button enables new protocols to be created and saved.

Figure 16 Home page: indicates the page that will be shown at start up. Appearance: indicates the background to be used when viewing the pages. Treatment type: - Ask: The device will always ask whether the treatment should be delivered automatically or manually - Automatic: The selected preset protocols will be delivered automatically. - Manual: The selected preset protocols will be delivered manually. Custom mode: If enabled, the bar at the top of the home page will show the word ‘Custom’ and the user will be able to create new and modify existing protocols. Language: It is possible to choose the language from those available.

Figure 15

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Maintenance: this brings up the maintenance page.

ENGLISH

4.5. HISTORY

ITALIANO

Clicking on the icon in the top right of the home page brings up the device history menu.

Figure 17

Servicing menu: A servicing menu is brought up that CANNOT be accessed by the user.

Figure 18 Accessing this page will show a list of the last protocols used in chronological order. Clicking on these will show the details of the treatment with the option to repeat it.

System reset: All protocols created or modified by the user, the history of treatments used and preferences chosen on the Settings page will be deleted, returning all parameters to their default values. The software version currently installed is shown in the bottom right.

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PORTUGUÊS

Treatment number: Indicates the number of sessions for which the lens has been used. By clicking ‘Replace lens’, the numeric code provided with the new lens can be entered. The counter will be reset and will restart from zero.

ESPAÑOL

Laser working hours: Indicates the total number of hours for which the laser has been used.

5. CLEANING 5.1. GENERAL RULES FOR CLEANING The user must keep the device clean. We recommend cleaning the surfaces of the device daily, and checking that the lens on the handpiece is clean at all times. In addition, clean the lens every time the handpiece is used in direct contact with patients.

•

Clean the surfaces of the device and handpiece with a soft cloth (preferably made of microfiber) slightly dampened with water.

•

Clean the handpiece lens using a cloth suitable for cleaning eyeglasses (not supplied) If necessary, slightly dampen with ethanol.  he device is not waterproof. Do not soak the T device. Do not allow any objects to enter the machine’s cooling slots. Do not attempt to clean the internal parts. Do not use solvents or alcohol to clean the surface of the screen and the device.

5.2. METHOD OF CLEANING  efore cleaning, the machine must be turned off B and the power cord must always be unplugged from the socket. We recommend following the instructions provided below while cleaning the device:

6. PRODUCT MAINTENANCE If the legal regulations in your country specify the maintenance and/or power emission inspection schedule, these must be complied with. The console and handpiece may need to be returned for periodic servicing. For the replacements and maintenance described below, please contact an EMS-approved service center. 6.1. LENS REPLACEMENT The anti-reflective coating on the safety lens at the handpiece output deteriorates with use. The device will alert the user with a video message when it is time to replace the lens.

 he user can choose to continue using the device T without replacing the lens, but this may cause damage that is not covered by the warrantee. Follow the instructions attached to the replacement lens to change it. To enter the code that resets the lens session counter, push the button ‘Replace lens’ (see Figure 17) and bring up the numeric keypad. By entering and validating the code provided in the booklet included in the packaging of the replacement lens, the counter will be reset and the message will disappear. 6.2. PERIODIC MAINTENANCE

 he maintenance tasks indicated below must be T performed at least once per year and only by qualified, EMS-approved individuals.

Figure 19

16

-

general operational check;

-

internal inspection of device;

-

internal cleaning;

-

check of laser source;

-

check and calibration of internal power meter;

-

check of electrical insulation.

Waste electrical and electronic equipment belonging to customers located in the European Union may be shipped to EMS for recycling in accordance with the WEEE regulations. The costs of recycling, exclusive of shipping fees, are covered by EMS.

ITALIANO

The product must not be discarded in domestic waste. If you wish to dispose of the product permanently, please comply with the applicable regulations in the country of use. Keep the original packaging until the product is to be disposed of permanently.

8. LIMITS OF LIABILITY

•

The electrical system to which the machine is connected conforms to the applicable standards.

•

The system is installed in accordance with the instructions provided with this user manual.

PORTUGUÊS

Installation, modifications and support interventions are carried out solely by authorized technical personnel.

ESPAÑOL

EMS assumes responsibility for the safety, reliability and performance of its laser system, provided that: •

ENGLISH

7. PRODUCT DISPOSAL

 MS assumes no responsibility for the direct E consequences or effects resulting from treatments carried out using the FT-245 in ways other than those shown in this user and maintenance manual.

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9. TECHNICAL SUPPORT AND WARRANTY Please contact the EMS-approved service center for any product maintenance or repairs. EMS denies any responsibility for the safety of the product and will declare the warranty void if servicing or repair work is carried out by an unauthorized third party or non-original replacement parts are used. The product must be returned in its original packaging as per the packaging guidelines. The product must be protected against damage during shipping. To protect the personnel of the authorized service center and for safety reasons during transport and shipment, all products and accessories returned to the factory for repair or servicing must be cleaned in accordance with the instruction manual. Repairs can be refused for products or accessories that have not been properly cleaned. The FT-245 is covered by a two-year warranty. EMS guarantees that the medical device is free from defects in materials or workmanship. The warranty may only be used if submitted together with a valid purchasing document. The warranty is only valid if the product remains in the possession of the original purchaser. The warranty covers the free replacement or repair of defective components of the laser device. In case of irreparable failure or repeated failure with the same cause, EMS may proceed with the replacement of the laser device. In such cases, the warranty for the new machine shall be valid until the end of the original contract. The warranty does not cover any parts that are defective due to negligence or inappropriate use (failure to follow the laser operating instructions), maintenance performed by unauthorized personnel, damage during transport, or circumstances that, in any event, cannot be attributed to defects in the manufacture of the laser device.

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The warranty does not cover the total or partial breakage of the fiber-optic bundle that can be attributed to negligent use. The continued use of the machine despite lens replacement alerts voids the warranty for all parts relating to the laser emission. Removal of the upper part of the machine for any reason must be performed by authorized personnel only. If this is not the case, the warranty will no longer be valid.

ENGLISH

10. TROUBLESHOOTING

To improve our quality of service, please provide the following information: -

Product reference number (REF)

-

Serial number (SN)

-

Software revision

10.2. SYSTEM WARNINGS In the event of a serious internal failure, the message ‘system error’ will appear and operation will be completely blocked.

ITALIANO

Ensure that the product and the accessories have been used as specified in the instructions for use.

- Product service history (for example, previous issues or repairs)

The FT-245 is equipped with a remote interlock jack that can be used to trigger an alarm following an event external to the system (Figure 20). Figure 21 In such cases, the machine must be restarted by pressing the ‘Reboot system’ button and, if the problem arises again, the EMS support center must be contacted, providing the code that will be shown in a video.

Figure 20 The correct functioning of the remote interlock system is checked on a weekly basis by opening the access door to the area protected by the system during laser delivery. If everything works correctly, the device should immediately stop the delivery, which can only be restarted once the door has been closed and the machine has been reset. If this does not occur, or if the alarm sounds when it shouldn’t, check the integrity of the entire system, paying particular attention to the correct wiring of the connector, which should be positioned correctly in the corresponding jack, and visually check the integrity of the connection leads and the system. If the problem persist, contact the Technical Support department.

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PORTUGUÊS

ESPAÑOL

10.1. REMOTE INTERLOCK

10.3. TROUBLESHOOTING The table below shows some problems that can easily be identified and resolved by users: PROBLEM

HOW TO PROCEED Check that the power cord is correctly inserted and that the system is powered in accordance with the technical specifications.

The system does not start

Check the power cord for visible damage. If in doubt, replace it with one with the same characteristics. Check that the ignition key and emergency stop button are in the correct positions. Check that the fuses in the power cord housing are intact (see section 10.4).

The absence of the laser aiming beam at the distal end of the transmission system, a reduction in its brightness or a scattered appearance may When the status is ‘READY’, the red guide indicate damage to or a fault in the transmission system. Immediately light does not come on contact technical support; do NOT use the machine if this situation arises. The average output optical power is lower than that of the parameter The message ‘low power’ appears on the settings. Turn off and restart the device. If the message remains visible display during delivery, contact the support center as soon as possible. The average output optical power is higher than that of the parameter The message ‘high power’ appears on the settings. Turn off and restart the device. If the message remains visible display during delivery, contact the support center as soon as possible. 10.4. CHECKING AND REPLACING FUSES If the FT-245 cannot be turned on, it is necessary to check the fuses.  lways turn off and disconnect the machine from A the electrical power supply before checking or replacing the fuses. The fuses are located on the back of the device, within the power socket (Figure 3).

Figure 22

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DAMAGED FUSES MUST BE REPLACED WITH THE SAME TYPE OF T1.6AL250V FUSES. Proceed as follows: •

remove the plug of the power cord from the mains electrical socket;

•

remove the power cord from the power socket of the device;

•

wait for three minutes;

•

the fuses are located in a small plastic block that should be removed by inserting a flat-head screwdriver into the middle slot and pulling outward (Figure 22);

•

check that the fuses are intact: if in doubt, we recommend replacing both;

•

insert the new fuses into their casing and push the block back into the socket.