I-Tech I-TECH 10000 Скачать руководство пользователя | Manualshive

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IACER Srl

2

MNPG179

CAUTIONS

The CAUTION message appears before operations, which, if not correctly
performed, may cause damage to the machine and/or its accessories.

!WARNING!

This signals operations or situations, which, if unknown to the operator, or
incorrectly carried out, may harm the operator.

Manufacturer

I.A.C.E.R. S.r.l.

Via S. Pertini, 24/a • 30030 Martellago (VE)

Tel. 041.5401356 • Fax 041.5402684

IACER Srl. is an Italian manufacturer of medical devices (certified CE no.
MED24021 from the Notified Body no. 0476, Kiwa Cermet Italia Spa).

Declaration of conformity

I.A.C.E.R. S.r.l

Via S.Pertini 24/A

–

30030 Martellago (Ve), Italia

herewith declares under its own responsibility, that the products

I-TECH LA8000

I-TECH LA10000

UMDNS Code

: 12299

Batch no.:

Series no.:

have been designed and manufactured according to the European Medical
Device  Directive  93/4/EEC  (transposed  in  Italy  by  the  D.Lgs.  46/97),  as
modified  by  the  Directive  2007/47/EC  (D.Lgs.37/2010)  and  further
modifications/integrations.
The products have been assigned to class IIb, according to Annex IX, rule 9
of  the  Directive  93/42/EEC  (and  further  modifications/integrations)  and
bear the mark

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Содержание I-TECH 10000

Страница 1: ...USER MANUAL MNPG179Rev 2of03 07 2019 Laser therapy ...

Страница 2: ......

Страница 3: ... TECHNOLOGY 11 INDICATIONS 13 CONTRAINDICATIONS 13 WARNINGS 14 PATIENT PREPARATION 16 INSTRUCTIONS FOR USE 16 Warning 16 Connections 18 Start up and protection password 18 Main menu 19 Program selection 20 Selection of free programs 22 End of treatment 24 Last 10 programs 24 Setup 24 DEVICE S CARE 25 MAINTENANCE 25 General indications for a proper use 28 TROUBLESHOOTING 29 DISPOSAL 30 WARRANTY 31 ...

Страница 4: ...IACER Srl ii MNPG179 ...

Страница 5: ...kept at hand for quick reference and correctly stored The manufacturer declines all responsibility for improper use of the device use contrary to specific national laws incorrect installation defective power supply improper maintenance unauthorized modifications and interventions use of material or spare parts that are not specific for the model partial or complete non observance of the instructio...

Страница 6: ...ED24021 from the Notified Body no 0476 Kiwa Cermet Italia Spa Declaration of conformity I A C E R S r l Via S Pertini 24 A 30030 Martellago Ve Italia herewith declares under its own responsibility that the products I TECH LA8000 I TECH LA10000 UMDNS Code 12299 Batch no Series no have been designed and manufactured according to the European Medical Device Directive 93 4 EEC transposed in Italy by t...

Страница 7: ...ion EN 60825 1 equipment unsuitable for use in presence of a flammable anesthetic mixture containing air oxygen and nitrous oxide equipment suitable for continuous operation equipment unsuitable for outdoors use Purpose and scope Clinical intended use Therapeutic Environmental intended use Ambulatory and in hospital I TECH LA8000 10000 is an electro medical device that delivers treatments of laser...

Страница 8: ...att Two delayed type fuses T T2 5A Backlit LCD display 128x64 pixel graphic display Power Settable from 1W to 8W 10W 3 Emission wavelength of laser diode 974nm 3nm Laser classification IEC 60825 1 Class IV DNRO m 24m 3 Dimensions of the SPOT with extended spacer 10mm2 3 Divergence of the beam 20x30 milliradians 3 Modulation From 10Hz to 10000Hz Duty Cycle Modulation From 10 to 90 ON Mode Trigger P...

Страница 9: ...the skin Around 38 mm Spot area Around 10mm2 3 Operating conditions environmental temperature From 10 C to 40 C relative humidity From 15 to 93 without condensation atmospheric pressure 500 1060 hPa Conditions for storage transport with the device in the packaging provided by the company environmental temperature From 5 to 40 C relative humidity From 15 to 93 without condensation atmospheric press...

Страница 10: ...IACER Srl 6 MNPG179 Device and command description ...

Страница 11: ...IACER Srl 7 MNPG179 Labels ...

Страница 12: ...ics connector LABEL 4 Placed on one side of the device in warns on the danger of the laser radiation LABEL 5 Placed on one side of the device LABEL 6 Placed on the back of the device it resumes the principal information of the device LABEL 7 Placed on the cable indicates the cable LABEL 8 Placed on the back of the device laser exit at the end of the fiber optics I TECH Batch n Date Probe LA8000 LA...

Страница 13: ... 12 It indicates the emergency stop button LABEL 13 It indicates the position of the laser aperture Symbol Meaning Manufacturer s logo CE product mark released by the Notification Body no 0476 Class of isolation I with applied part type B according to EN 60601 1 ed III Manufacturer s information Manufactured date YYYY MM Consult the instructions for use FUSES T2 5A 230V AC 50Hz INTERLOCK ...

Страница 14: ...to wear protective glasses Packaging content The I TECH LA8000 LA10000 box contains n 1 user manual n 1 power supply cable shuko plug n 2 spare fuses see table Technical features n 1 handpiece n 1 pedal n 1 interlock key n 1 smart card n 1 protective glasses n 1 case for transportation Control the content of the package If some element is missing please contact immediately the authorized vendor No...

Страница 15: ... therefore permits immediate alleviation of the symptoms of inflammation and degeneration in the fields of orthopedics neurology and dermatology and reduces healing time it is also a valid form of therapy especially in the field of Sports Medicine because it permits quick recovery and healing for many professional sports people for whom time is of the essence The benefits of Laser therapy Laser th...

Страница 16: ...he deep stimulation of tissue for rapid and uniform cell regeneration the I TECH LA8000 10000 permits deep stimulation for treating internal tissue and structures like the articulation of the femur and chronic conditions like arthritis it can be used in various fields like sports medicine orthopedics neurology dermatology rheumatology dentistry conservative periodontics implantology oral pathology...

Страница 17: ...ct exposure to eyes class 4 lasers are potentially harmful to the retina although the likelihood of damage to the retina is extremely low The operator must however wear the special safety glasses provided Pregnancy the laser must not be used above a pregnant uterus The laser can however be used for pregnant women providing it is not directed at the abdomen Neoplasia do not use the laser on an undi...

Страница 18: ... and drugs triggers this response It is recommended that patients at allergic risk or patients with a history of such reactions are tested with a minimum time of treatment Means of fixation metal plates plastic DO NOT constitute contraindication to the use of lasers which can be safely used on metallic implants sutures and plastics Warnings Recommendations Read the entire operating manual The cust...

Страница 19: ... the I TECH LA8000 After carefully inserting the fiber optic in the socket turn the locking ring clockwise to the end of its stroke without forcing it In any case turn the locking ring to bring the reference mark on this parallel with the one on the socket of the fiber optic If the laser tip of the I TECH LA8000 needs to be disconnected put the protective caps back on the tip of the fiber optic an...

Страница 20: ... follows 1 clean the skin with care where the head of the laser is to be positioned using either water and soap or alcohol 2 dry the skin thoroughly Cleaning and disinfection must be carried out systematically before treating the patient Instructions for use Warning PRELIMINARY NOTES Utilizzare un nome diverso per ogni protocollo personalizzato utilizzando lo stesso nome per due protocolli persona...

Страница 21: ... the energy settings configured on the display For this reason keep the handpiece in contact with the affected area during emission of the laser After activating the handpiece by means of contact with the plates avoid moving it towards or directing it at other areas NEVER DIRECT THE HANDPIECE AT PARTS OF THE BODY THAT ARE SENSITIVE TO LASER BEAMS LIKE THE EYES DO NOT LOOK INTO THE BEAM OF THE HAND...

Страница 22: ...ve socket on the front panel fastening carefully the connector so that the mark on the connector of the handpiece will be aligned with the mark on the front panel of the device ATTENTION do not strain the connection and screw only to its limit A wrong connection or a forced connection could damage the optical fiber of the handpiece Routinely check the condition of the power cord and the cable conn...

Страница 23: ... from 0 4 to 10 mm2 The equipment works most efficiently with the spacer fully extended for a laser output of 10mm2 This special HANDPIECE therefore ensures a broader range of action and a higher degree of accuracy for the anatomical area to be treated In the FREE section the operator can edit the treatment parameters at will In particular the parameters in question are number of Points 1 to 9 or ...

Страница 24: ...rigger point mode while the second is in scanning mode The operator is free to choose whether to proceed with the second phase or not the settings of the second phase appear at the end of the first one and the operator is prompted to either continue or end the session 4 When the ENTER key is pressed the I TECH LA8000 10000 prompts the operator to confirm and start treatment Pressing the ENTER key ...

Страница 25: ... returns to the main menu PROGRAMS LIST N Name Watt s Cycle Hz Duty Cycle Time r min Punti p Area cm2 Joule cm2 1 Analgesic 1 1 100 50 4 4p 120J 2 Analgesic 2 5 200 60 5 50cm2 18J cm2 3 Neck pain 1 1 100 50 4 4p 120J 4 Neck pain 2 5 100 60 5 50cm2 18J cm2 5 Lower Back Pain 1 4 200 10 4 4p 96J cm2 6 Lower Back Pain 2 4 CW 4 50cm2 19J cm2 7 Bursitis 3 500 60 8 50cm2 17J cm2 8 Baker s Cyst 3 1000 10 ...

Страница 26: ... cm2 25 Muscle injuries 4 500 30 5 25cm2 14J cm2 26 Meniscopathy 2 500 50 2 5cm2 24J cm2 27 Sinovitis 4 1000 30 6 25cm2 17J cm2 28 Muscle Strain 6 500 30 10 25cm2 43J cm2 29 Tendinopathy 2 100 40 2 5cm2 19J cm2 30 Carpal tunnel 3 10 50 5 25cm2 18J cm2 Selection of free programs I TECH LA8000 10000 enables the user to set manually the parameters of the protocols in FREE mode In fact the FREE sectio...

Страница 27: ...of the LA10000 This parameter does not change in relation to the other parameters Cycles For enabling and modulating the laser emission The first choice is Continuous where the emission of the laser is continuous CW while the second choice is numerical for setting the emission frequency between 10Hz and 10000Hz When the latter is selected a new parameter appears to the right of the set frequency T...

Страница 28: ...emit the laser it permits a pause with the actuator not pressed of no more than 3 minutes After this length of time the device disables the laser and returns to the main menu ENTER key during therapy the operator can end the session at any time by pressing the ENTER key Laser Stop it is possible to end therapy at any time by pressing the emergency stop button which shuts down the device completely...

Страница 29: ...time in order to determine the diode s lifetime It is a parameter useful to the manufacturer used for the device electronic problems resolution Device scare Maintenance For safety reasons ALWAYS turn off the main switch at the back of the equipment and unplug it before carrying out any maintenance or cleaning operations For an effective use of the device and to guarantee the optimal performances i...

Страница 30: ...fore carrying out any maintenance or cleaning operations It is strictly recommended not to use diluents detergents acid solutions aggressive solutions or flammable liquids to clean the external surfaces of the machine and its accessories The use of these substances together with improper use of the accessories can cause irreparable damage to the equipment and to the electrodes and render the warra...

Страница 31: ... to replace correctly the fuses on the back of the device follow the instructions below turn off the equipment unplug the equipment use a screwdriver to open the fuse holder tray making sure to insert the screwdriver in the slot of the fuse holder tray and lever it outwards remove the fuse holder structure sliding it along the guide remove the fuses and replace them with the same number of new one...

Страница 32: ...emble the handpiece applicator this could result in damage to the handpiece and render the warranty null and void Do not for any reason disassemble the equipment for the purpose of cleaning or inspection there is no need to clean inside the machine and in any case the machine should be opened only by the authorized specially trained technical staff from IACER Srl NEVER allow liquids to enter the c...

Страница 33: ...onnector of the equipment The power cable is worn and damaged Replace the power cable The emergency switch is turned off Turn on the emergency switch One or more of the fuses are defective or damaged Replace the fuse s that are missing defective or damaged The electronic control circuit is defective Contact an IACER Srl assistance center The LCD display on the front panel does not turn on Some com...

Страница 34: ...ss of pressure in the actuator Check air tightness When any of the following conditions occur unplug the equipment and contact the IACER Srl technical assistance service the cable or rear integrated power supply module are worn or damaged liquid has entered the equipment the equipment has been exposed to rain Only authorized technical staff from the manufacturer may access the internal parts of th...

Страница 35: ...For further information on the obsolete equipment disposal please contact the dedicated disposal service or the shop in which the device was bought Warranty IACER Srl guarantees a warranty period unless information contained in this manual regarding installation use and maintenance is strictly adhered for 12 months from the date of purchase For more information on the warranty please contact the d...

Страница 36: ...s which have been in contact with patients Any equipment which the technical department does not consider hygienic Italian law D Lgs 81 2008 on safety in the workplace will not be accepted 3 disassemble accessories and any mechanical supports 4 use original box and packing materials 5 enclose detailed information regarding the nature of the problem to facilitate the technical department s interven...

Страница 37: ...installed in homes and health establishments The equipment does not generate significant radio frequency energy and is adequately immune to radiated electromagnetic fields Therefore it does not detrimentally interfere with radio electric communications electro medical equipment for monitoring diagnosis therapy and surgery office electronic devices such as computers printers photocopiers fax machin...

Страница 38: ...ons CISPR 11 Group 1 The device must emit electromagnetic energy at RF in order to perform its intended function So its RF emissions are very low and therefore it does not affect electronic equipment placed in the surroundings RF Emissions CISPR 11 Class B The device is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage ...

Страница 39: ... material the relative humidity should be at least 30 Transistor Electri cal fast transient IEC 61000 4 4 2kV for power supply lines 2kV per power supply lines Mains power quality should be that of a typical commercial or hospital environment Impulses IEC 61000 4 5 1kV line to line 1kV line to line Mains power quality should be that of a typical commercial or hospital environment Voltage dips shor...

Страница 40: ...c environment guidance 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT per 5s 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT per 5s power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 30A m 30A m Power frequency magnetic fields should be at levels characteristic of a typ...

Страница 41: ...ed RF IEC 61000 4 6 3Vrns from 150kHz to 80MHz 6Vrms from 150kHz to 80MHz in ISM band 3Vrns from 150kHz to 80MHz 6Vrms from 150kHz to 80MHz in ISM band P V d 1 5 3 P V d 1 12 for ISM band Radiated RF IEC 61000 4 3 3V m from 80MHz to 2 7GHz 3V m E1 V m P E d 1 12 𝑓𝑟𝑜𝑚 80𝑀𝐻𝑧 𝑡𝑜 800𝑀𝐻𝑧 P E d 1 7 𝑓𝑟𝑜𝑚 800𝑀𝐻𝑧 𝑡𝑜 2 7𝐺𝐻𝑧 Radiated RF to RF wireless communication equipment IEC 61000 4 3 3V m from 80MHz to ...

Страница 42: ...s such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the I TECH LA8000 is used exce...

Страница 43: ...𝑀𝐻𝑧 ISM band 𝑓𝑟𝑜𝑚 80𝑀𝐻𝑧 𝑡𝑜 800𝑀𝐻𝑧 𝑓𝑟𝑜𝑚 800𝑀𝐻𝑧 𝑡𝑜 6𝐺𝐻𝑧 to RF wireless radio communication equipment 0 01 0 12 0 2 0 12 0 23 0 1 0 38 0 63 0 38 0 73 0 2 1 1 20 2 0 1 20 2 30 1 8 2 10 3 80 6 3 3 80 7 30 100 12 00 20 12 00 23 00 For transmitters rated at a maximum output power not listed above the recommended separation distance 𝑑 in meters m can be determined using the equation applicable to the freq...

Страница 44: ......

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