GME LinScan 808 User Manual Download | Manualshive

Page: 19 / 47

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4. Installation

GME LinScan Revision 14, dated 2016-06-08

Page 18 of 46

Warning!

Hazard:

The occurrence of errors during the functional test indi-

cates damage to the device. A proper function is no longer guar-
anteed. Patients or users could be injured by using the damaged
unit.

Action:

Stop use of the device immediately if errors occur during

the functional test. Turn the unit off and contact the manufacturer
or your dealer.

!

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Summary of Contents for LinScan 808

Page 1: ...Copyright 2016 GME German Medical Engineering GmbH GME LinScan User Manual...

Page 2: ...s of copyright law without the consent of the GME German Medical Engineering GmbH is forbidden and punishable This applies in particular to duplications translations microfilming and storage and pro c...

Page 3: ...ional Test 16 5 Device Operation 19 5 1 Starting the device 19 5 2 Main Menu Choice of treatment 19 5 3 Setup Menu Setting the System Parameters 20 5 4 Treatment menu Setting the treatment parameters...

Page 4: ...2016 06 08 Page 3 of 46 6 5 Disposal 32 6 6 Refilling cooling liquid 32 7 Specifications 33 7 1 Specifications and Certification 33 7 2 Device Labeling 34 7 3 Electromagnetic compatibility EMC 36 7 4...

Page 5: ...nsportation un packing installation medical application maintenance decommissioning and scrapping In the instructions you will find two types of advice for potential hazards 1 Fields with the heading...

Page 6: ...le phones portable phones or headsets can interfere with the unit Action Wireless communication devices have to be switched off before starting treatment Warning Hazard The device emits electromagneti...

Page 7: ...the device may ignite inflammatory substances such as gases or liquids and cause fire or explosions Especially when working in the vicinity of tubes or cavities of the body that contain flammable sub...

Page 8: ...e has been done or that it has been opened by an unauthorized person This device may not be modified without the permission of the manufacturer If the unit has been modified appropriate examina tions...

Page 9: ...r call service to have a repair maintenance performed The applicator directs the laser light along an optical path to a scanning device for deflecting the laser beam The applicator is hand held by the...

Page 10: ...r 980nm the laser radiation has the following characteristic values x The maximum permissible exposure MPE is 16 W m x The safety distance for damage to the eyes NOHD is 4 36 km x The minimum optical...

Page 11: ...with Section 2 3 have to be taken x Substances applied to the skin of the patient such as creams ointments perfumes or ingest ed photosensitizing drugs can alter the interaction of the incident light...

Page 12: ...cations have been reported in treatments with the same or similar intended use in the literature and can therefore occur also in treatments with the LinScan a For all indications x Erythema x Blister...

Page 13: ...rs x Anti coagulation medication x Presence of varices that are feeding telangiectasias d In addition to a for the indication pigments x Blood coagulation disorders x Personal or family history of mel...

Page 14: ...transport the device without the ap propriate box Caution Hazard The transport or shipping of the device without appropri ate packaging may damage the device and thus lead to a malfunc tion of the dev...

Page 15: ...faces such as mirrors x Room temperature and humidity The device may only be operated within the acceptable tem perature and humidity range in accordance with the technical data see chapter 7 1 x Heat...

Page 16: ...laser light when the door is closed and thus the remote door interlock contact is closed If the door is opened laser emission is stopped Double check that all parts are connected correctly and securel...

Page 17: ...screen is displayed which prompts you to enter a PIN This PIN can be ob tained from the person doing the initial training on the use of the device After entering the PIN the device displays the main...

Page 18: ...area The aiming beam moves through the same optical system as the working beam Therefore the aiming beam offers a suitable means of verifying the integrity of the optical system If the target beam is...

Page 19: ...during the functional test indi cates damage to the device A proper function is no longer guar anteed Patients or users could be injured by using the damaged unit Action Stop use of the device immedia...

Page 20: ...the use of the device or you can define your own PIN In chapter Setup menu this is described After entering the correct PIN the device displays the main menu If you entered the PIN incorrectly three t...

Page 21: ...ecause of legal reasons x The button Service is only relevant for service technicians It leads to a PIN protected menu Never try to guess the service PIN of the device or do changes in the service men...

Page 22: ...icon of the indication that you selected on the main menu In addition depending on the indications more buttons appear In the shown example these are the skin type the hair thickness and the hair col...

Page 23: ...want to use these parameters you must first unlock the red zone by touching the lock Only after that you can move the slider into the red zone Warning Hazard The unit allows you to treat even with ag...

Page 24: ...yed Pressing the Re set button sets this counter to zero The remaining 3 buttons indicate the selected parameters for the scan pattern namely its size the scan mode and the repositioning break Press o...

Page 25: ...on of laser pulses starts when you press the hand or foot switch It stops as soon as the selected skin area was treated completely the hand or foot switch is released the door contact is open the STOP...

Page 26: ...switch Laser pulses can be triggered by pressing this switch if the hand switch has been activated in the setup menu Please note that the operator has to hold the handle of the applicator tightly in o...

Page 27: ...l down or be damaged by sharp items edges when not placed on the appropriate applicator holder while not in use Action Always place the applicator on the applicator holder when not using it 5 7 2 Usag...

Page 28: ...that the screw points in the direction of the applicator handle Figure 5 Please ensure that the adapter flatly touches the colored elastomer Figure 5 Small spot adapter mounted on the sapphire crysta...

Page 29: ...o the sapphire crystal Action Please check whether the screw of the adapter points in the direction of the applicator handle before using the small spot adapter 5 8 Menu Individual Parameters Storage...

Page 30: ...ain switch on the left side of the device In an emergency the unit can be switched off be pressing the red emergency stop button on the top of the base unit Any laser emission is stopped immediately T...

Page 31: ...nit is switched on Warning Hazard In case of an accidental triggering of laser pulses during the cleaning process of the sapphire crystal the eyes or skin of the cleaning person could be harmed Action...

Page 32: ...utor Regardless of the actual use at least once per year an inspection and service of the equipment is compulsory Please contact the manufacturer or his authorized distributor in time Caution Hazard T...

Page 33: ...ng cooling liquid If you note a noisy sound of the internal pump or the message Liquid flow too low appears there is probably not enough cooling liquid in the device Use the provided refill kit to inc...

Page 34: ...ondensing Ambient temperature during storage and transport 10 C to 60 C Humidity during storage and transport 100 Cooling Integrated water cooling Cooling liquid x mixture of 2 parts distilled water a...

Page 35: ...7 Specifications GME LinScan Revision 14 dated 2016 06 08 Page 34 of 46 7 2 Device Labeling Name plate Laser warning label...

Page 36: ...te of Manufacture Do Not Discard in Trash Refer to Instructions For Use User Manual Manufacturer Symbol Type BF Applied Part Protective earth ground European Conformity TUV Rheinland logo Laser apertu...

Page 37: ...f your device Using other cables or connectors can negatively affect the EMC of the device When using such ca bles or connectors other devices placed in the surrounding could be disturbed or the other...

Page 38: ...push pull 2kV power supply common mode Voltage drops short inter ruptions and voltage varia tions IEC EN 61000 4 11 5 UT for 0 5 cy cles 40 UT for 5 cy cles 70 UT for 25 cycles 5 UT for 5 sec The powe...

Page 39: ...n data incomplete see trace log Software component defec tive Switch off and on de vice again If error per sists contact service 210 Missing service configuration file Software component miss ing or d...

Page 40: ...s contact service 227 Please fill in all fields Input data is missing Please enter data 228 Saving timeformat failed Hardware or software com ponent defective Switch off and on de vice again If error...

Page 41: ...ave the language failed Hardware or software com ponent defective Switch off and on de vice again If error per sists contact service 304 Read the language error file failed File is missing or corrupte...

Page 42: ...essage not transmitted correctly Switch off and on de vice again If error per sists contact service 417 scanner data error Scanner detects wrong missing data Switch off and on de vice again If error p...

Page 43: ...ponent defective Switch off and on de vice again If error per sists contact service 439 Calibration failed Start calibra tion again Hardware or software com ponent defective Only for service 440 Illeg...

Page 44: ...vice again If error per sists contact service 463 bootloader in error state Hardware or software com ponent defective Switch off and on de vice again If error per sists contact service 464 erase flash...

Page 45: ...vice 482 Laser diode voltage error Hardware component defec tive Please contact service 483 Laser diode current offset too low Hardware component defec tive Please contact service 484 Laser diode curr...

Page 46: ...and on de vice again If error per sists contact service 517 Applicator warmup error Hardware or software com ponent defective Switch off and on de vice again If error per sists contact service 518 Wro...

Page 47: ...efective Switch off and on device again If error persists contact service 598 Applicator System Tick Error Hardware or software com ponent defective Switch off and on de vice again If error per sists...

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