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Enraf Nonius Endolaser 120, Инструкция по эксплуатации

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Enraf Nonius Endolaser 120 Скачать руководство пользователя страница 42

 

Page 42 of 46 

EN109-1633750-40 IFU

 

Treatment time 

0:00 

–

 5:00 / 0:05, 5:00 

–

 10:00 / 0:30, 10:00 

–

 30:00 

/ 1:00 

Beam divergence 

489 x 140 mrad 

Pulse duration 

Continuous 

Maximum laser output 

100 mW ± 20% 

Nominal ocular hazard distance 

1 m 

 

 

Laser Protective Goggles 

 

Optical density (808 - 840 nm) 

4+ 

Optical density (840 - 950 nm) 

5+ 

CE rating (808 

–

 840 nm) 

DIRM LB4 

CE rating (840 

–

 950 nm) 

DIRM LB5 

 

Technical modifications reserved 

 

Safety and performance standards 

Medical device classification 

IIa; Rule 9 Annex IX of 93/42/EEC 
This equipment complies with all requirements of the 
Medical Device Directive (93/42/EEC). 

IEC 60601-1 

General requirements for the safety of electrical medical 
systems. 

Safety class according to IEC 60601-1 

Electrical safety class II  

Applied parts 

Type B Applied part. 

 

IEC 60601-1-2 

Electromagnetic disturbances 

–

 requirements and tests. 

IEC 60601-2-22 

Particular requirements for basic safety and essential 
performance of surgical, cosmetic, therapeutic and 
diagnostic laser equipment. 

IEC 62304 

Medical device software. 

IEC 62366 

Application of usability engineering to medical devices. 

Classification of laser according to IEC 
60825-1 

3B 

 

Essential Performance 

•

 

Activation of the Remote Interlock should interrupt emissions 

•

 

Warning should be visible to operator wearing Laser Safety Goggles 

•

 

May not provide unintended Laser emission 

 
 
 
 

 

 

 

 

 

Содержание Endolaser 120

Страница 1: ...Page 1 of 46 EN109 1633750 40 IFU Endolaser 120 EN109 1633750 40 IFU December 16 2019 Instructions for use ...

Страница 2: ... 6 3 Device components 8 4 Package contents 10 5 Installation 11 6 Intended use and intended user 14 7 Indications 15 8 Contra indications 16 9 Precautionary instructions 17 10 Operation 20 11 Application information 34 12 Maintenance and troubleshooting 38 13 Specifications 41 14 Contact 44 15 Product liability 44 ...

Страница 3: ...100 mW continuous cluster Laser Probe CP4X400C 808 nm 4x400 mW continuous cluster Laser Probe The mounted applicators provide depending on type 808 nm or 905 nm laser light Depending on the area of treatment single diode and cluster applicator types are available The 905 nm GaAs Gallium Arsenide Laser Probe delivers pulses in nanoseconds producing average powers of 100 mW and peak powers up to 100...

Страница 4: ...ation Analgesia Enhanced Immune Function Antimicrobial One important way in which laser therapy adds energy is through photon absorption by mitochondria These tiny organelles which have been called the powerhouses of the cell are found in most plants and animals Mitochondria are able to absorb laser light which then activates a series of reactions to increase and store more cellular energy in the ...

Страница 5: ...rs are based on the definition of the treatment dosage Treatment Dosage D I x t Joule cm2 I Power Density Watt cm2 t time sec I P A Watt cm2 P Power Watt A Area cm2 In clinical protocols mode all the parameters are preset In manual operation mode the treatment dosage can be directly set in the user interface by selecting the preferred parameters Two operation modes are available 1 Points cm2 2 Mil...

Страница 6: ...u must Type B applied part complying with the specified requirements to provide protection against electric shock particularly regarding allowable patient leakage current and patient auxiliary current Temperature Range Indicates acceptable temperature range Humidity Limits Indicates acceptable relative humidity Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical d...

Страница 7: ...Council of Directive concerning Medical Devices and that this device is under the direct supervision of the Notified Body Emergency Stop button Laser aperture indicates laser opening Warning laser radiation Remote Interlock Avoid direct eye exposure Explanatory label affixed to laser probe cable ...

Страница 8: ...ut the device such as type and serial number as well as connection data such as mains voltage and maximum current consumption 3 Mains switch To switch the unit on and off When turning the unit off the display remains visible for a few seconds low energy method 4 Connector for Mains Cable Connect supplied Mains Cable here to power the device 5 Laser Probe LED indicator Shows status of probe Green L...

Страница 9: ...te Interlock Connection to external Remote Interlock system at the back of the Laser Probe Holder 11 Emergency Stop Button Immediately abort laser output 12 Laser Probe Holder Holder for Laser Probe 13 Connection Laser Probe A Connect Laser Probe applicator left hand side here 14 Connection Laser Probe B Connect Laser Probe application right hand side here 15 Laser Aperture Single Diode Opening fo...

Страница 10: ...formation Booklet 3444 820 Laser Safety Eyewear 2 goggles included 3444 357 Mains Cable 250V 2 5A 2 5 meters black Optional accessories Article number Description 1633 850 Laser Probe Holder 1632 801 LP100P 905 nm 100 mW pulsed single Laser Probe 1632 802 LP500C 808 nm 500 mW continuous single Laser Probe 1632 803 CP4X100C 808 nm 4x100 mW continuous cluster Laser Probe 1632 804 CP4X400C 808 nm 4x4...

Страница 11: ...yrene filling Be very careful when removing the contents of the pack Connection to Mains supply Use of any other cable other than the supplied power cable is strictly PROHIBITED as it affects patient safety and the proper functioning of the device Before connection of the device to the local Mains check that the Mains voltage and frequency stated on the identification plate of the device correspon...

Страница 12: ...o probes the supplied holder link cable will need to be used to bridge the two remote interlocks together The Remote Interlock interrupts the power supply to the attached probes and will require a power OFF ON switching of the device to restart If an external Remote Interlock circuit is required a twisted pair must be provided with a minimum diameter of 0 6 mm 20 m max On the safety circuit side a...

Страница 13: ...Page 13 of 46 EN109 1633750 40 IFU Reed Proximity Switch Reed Proximity Switch DC Jack ...

Страница 14: ...tes light of a single wavelength LLLT emits no heat no sound or vibration The light energy absorbed into the patient s tissue triggers biological changes at a cellular level Intender user The Endolaser 120 is intended to be used and shall only by used by or under the supervision of professional users in the field of physical medicine and rehabilitation at professional healthcare facilities ...

Страница 15: ...rome Precautions Low Level Laser Therapy can be applied with caution Over infected tissue e g infected open wound Over the sympathetic ganglia vagus nerves and cardiac region in patients with heart disease Over photosensitive areas Patient with epilepsy Areas of altered skin sensation Areas with Tattoos Experienced clinicians may use Low Level Laser Therapy LLLT with caution e g at lower intensiti...

Страница 16: ...s over areas of decreased sensation over the thyroid gland over the heart or vagus nerve of cardiac patients persons with infections who have a compromised immune function persons with epilepsy Note s 1 Metal and plastic implants as well as pacemakers are not contra indicated and LLLT can be used safely 2 The listed contraindications apply to both continuous and pulsed modes Potential adverse effe...

Страница 17: ...e identification plate of the device corresponds with those of the local Mains Make certain that the device is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes Do not place the device in a location where the power cord could pose a possible tripping hazard or could be pulled out of the wall socket ...

Страница 18: ... while cleaning the device Do not drop the device The device should not be used when mechanical damage is noticed This includes damaged cable insulation In the event that an error message or warning appears immediately stop all use of the device Shutdown and restart the device If the problem persists contact the supplier or Enraf Nonius B V for service Errors and warnings indicate an internal prob...

Страница 19: ...tions equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to any part of the Endolaser 120 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The Endolaser 120 should only be operated with the original power cable specified in the list of contents delivered Operating the...

Страница 20: ...end of the self test the device enters the Key control screen Key Code Control Endolaser 120 should be protected against unauthorized use by entering user defined key code to unlock the device The device is protected with a key code control A user defined key code allows access to the graphical user interface Without this key code the device will not operate Enter the key code to unlock the device...

Страница 21: ...he laser output This state will be shown by the pause icon of the run status indicator above the Time Pressing the laser trigger again will continue treatment When the laser is active pushing the laser stop icon in the user interface or the emergency laser stop button on the Laser Probe holder will terminate laser emission To restart a treatment parameters will need to be set up again Navigation T...

Страница 22: ...ce to factory defaults Set Language 1 Select System Settings 2 Select Language 3 Select the preferred language with the buttons 4 Push OK to confirm and to return to the previous menu Set Brightness To change the Brightness of the screen 1 Select Brightness 2 Adjust the brightness via the buttons Range 10 100 3 Push OK to confirm and to return to the previous menu ...

Страница 23: ...currently installed software version is shown 2 Push BACK to return to the previous menu Change Key Code Note In case the user defined key code has been forgotten use the recovery code 102030661 to reset to default code 1234 1 Select Change Key Code to change the unlock code for the device 2 Enter new Key Code 3 Press OK to confirm ...

Страница 24: ...ry Defaults will delete any favorites stored on the device and clear any system settings returning the device in its original factory state 2 Press Yes to confirm The Service menu is intended for Enraf Nonius qualified service organizations and can only be entered with an access code ...

Страница 25: ...ears of experience in the field The pre set clinical protocols are adjustable and rewritable 1 Select Clinical Protocols in the Home screen to activate the list 2 Select the button to scroll through the list 3 Select in the list the desired protocol or touch icon for more information about the protocol Protocol information screen 4 Touch the buttons to scroll through the pages 5 Select OK to go to...

Страница 26: ... connected probes When only a single probe is connected this screen is skipped defaults to this probe The treatment screen shows all parameters at a glance The parameters are preset according to the selected protocol and connected Laser Probe Parameters are changeable when in Laser Standby mode 7 Confirm the parameters by selecting OK ...

Страница 27: ...Points cm2 the probe will BEEP and pause when it s time to move to the next point 9 Press the trigger on the probe to continue The treatment will stop when the timer reaches 00 00 10 To pause treatment press the trigger on the probe again and the screen returns to the Laser Ready screen Press the trigger to continue 11 To terminate the treatment press the Laser Stop button or the Stop icon on the ...

Страница 28: ...therapy should be executed A or B The channel names are linked to the connected Laser Probe When only a single probe is connected this screen is skipped defaults to this probe If no probes are connected you can only select System Settings on the Home screen 3 Select the desired operation mode of the laser For manual mode Points cm2 you can select the dosage the number of points and joule per point...

Страница 29: ...eter settings Parameters are changeable when in Laser Standby mode Selecting manual mode Points cm2 will bring you to this treatment screen Set desired parameter and confirm by selecting OK to return to treatment screen Set desired parameter and confirm by selecting OK to return to treatment screen Select desired output power to return to treatment screen 5a When all parameters are set the Save Fa...

Страница 30: ...eatment time Output power mW The total dosage is automatically set depending on the other parameter settings Parameters are changeable when in Laser Standby mode Set desired parameter and confirm by selecting OK to return to treatment screen Select desired output power to return to treatment screen 5b When all parameters are set the Save Favorite and OK buttons appear Select OK to confirm The Lase...

Страница 31: ...otocol contains multiple Points cm2 the probe will BEEP and pause when it s time to move to the next point 7 Press the trigger on the probe to continue The treatment will stop when the timer reaches 00 00 8 To pause treatment press the trigger on the probe again and the screen returns to the Laser Ready screen Press the trigger to continue 9 To terminate the treatment press the Laser Stop button o...

Страница 32: ...re completely set as required you can choose to save the settings as favorites by pressing the store button Favorites can be stored as long as treatment has not been started 1 Press the store button to save the program settings 2 Select the program number via the buttons 20 store locations are available for the Endolaser 120 3 Push OK to confirm 4 Enter a name for your favorite 5 Push OK to save t...

Страница 33: ...oad a program select a Favorite via the buttons The parameter screen will appear The favorite can only be started when the corresponding Laser Probe is connected 3 To delete a Favorite press the delete button L and select the Favorite to be removed via the buttons 4 Press OK to permanently delete the Favorite ...

Страница 34: ...ission of the laser in areas other than those to be treated Never return the handpiece to the parts of the body sensitive to the laser rays for example the eyes Do not look at the radius issued by the handpiece or the direct return which is reflected during treatment The Endolaser 120 is a near infrared NIR diode laser band generator designed and produced according to state of the art safety stand...

Страница 35: ...ode the device will not operate When the device has been inactive for a longer period of time the key control screen will reappear Unlock the device with the key code to continue Remote Interlock The Remote Interlock is located on the Laser Probe Holder It contains a DC jack that can be connected with an external Remote Interlock system It has a latching switch so that the power will need to be ma...

Страница 36: ...licator on the treated surface Gridding this technique also called point by point consists in making a grid by mapping the entire treatment surface area with 1 cm2 squares to guide the point by point application Each square centimeter corresponds to one point thus the related term point by point technique The grid can be made either visually or with a plastic sheet and a pen Gridding is used with ...

Страница 37: ...contamination between patients Ensure optimal device function Ensure post treatment equipment maintenance Follow manufacturer recommendations lmmediately report defects or malfunctions to technical maintenance staff Keep in mind that lasers are very susceptible to de calibration over time Power decreases as the device diodes ages thus requiring routine check and calibration measurements Lock the l...

Страница 38: ...play panel contains an anti reflective coating which needs special care when cleaned Use a soft and dry cotton cloth or micro fiber tissue to clean the panel To remove fingerprints or grease use a non abrasive glass cleaning agent Apply a small amount of the cleaning agent to a soft cotton cloth and then carefully clean the panel Laser Probe To prevent corrosion clean and dry the contact surface i...

Страница 39: ...ock or Emergency stop activated Restart the device by switching the power off and on Check Remote interlock connections if problem persists Unsupported Device Detected Disconnect to continue Troubleshooting The device should not be used when mechanical damage is noticed This includes damaged cable insulation In the event that an error message or warning appears immediately stop all use of the devi...

Страница 40: ...The service engineer will decide whether the device is suitable for use according to the specifications End of Life The Endolaser 120 contains materials which can be recycled and or are noxious for the environment Technical Maintenance Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty The manufacturer will not be held responsible for the resu...

Страница 41: ...e 500 mW CW LP500C Max power output 500 mW 20 Type GaAlAs Continuous Wavelength Near infrared Laser diode 808 nm 5 nm Duty cycle 10 100 in steps of 10 Beam divergence 225 x 77 mrad Pulse duration Continuous Maximum laser output 500 mW 20 Nominal ocular hazard distance 1 33 m Laser Probe Cluster 4x100mW CW CP4X100C Max power output 4 x 100 mW 20 Type GaAlAs Continuous Wavelength Near infrared Laser...

Страница 42: ...vice Directive 93 42 EEC IEC 60601 1 General requirements for the safety of electrical medical systems Safety class according to IEC 60601 1 Electrical safety class II Applied parts Type B Applied part IEC 60601 1 2 Electromagnetic disturbances requirements and tests IEC 60601 2 22 Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic la...

Страница 43: ...equipment could result The Endolaser 120 should only be operated with the original power cable specified in the list of contents delivered Operating the device with any other power cable can lead to increased emissions or reduced interference immunity of the device The Endolaser 120 is classified as a Group 1 Class B device according to CISPR 11 The Endolaser 120 device is suitable for use in all ...

Страница 44: ...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 B V entire liability under any provision of this agre...

Страница 45: ...Page 45 of 46 EN109 1633750 40 IFU ...

Страница 46: ...EN109 1433750 40 Copyright Enraf Nonius B V Vareseweg 127 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 info enraf nonius nl ...

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