AS 500. Instructions for Use. Version 1.0. December

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Transcription:

AS 500 Instructions for Use 1

Contents General Notes... 3 Safety standard... 3 Safety Precautions... 4 Device out of use:... 4 Description of the Device / Proper Usage... 5 Technical data...5 Laser probe... 5 Content of delivery... 5 Explanation of the pictograms... 6 Funcional elements on the front panel and probe... 7 LED-lamps...8 Starting operation... 8 Operational modes... 9 Before starting the therapy mode... 10 Release of the laser beam... 10 Charging the battery... 11 International plugs... 11 Laser-protection goggles... 12 Cleaning / Disinfecting... 12 Maintenance/Calibration... 12 Disposal... 12 Warranty...12 2

General Notes These operating instructions must be read carefully before starting the device. These operating instructions describe the correct usage of the AS 500 and also point out any potential risks. These operating instructions are to be read and observed by all persons who operate, use, service and inspect the device. The medical laser device should only be operated by authorized, medically-trained personnel that have been properly instructed in using the device and have been made aware of the dangers of laser radiation as well as the accident prevention regulation BGV 11 Laser radiation and the DIN VDE 0837 directive Radiation Safety for Laser Devices. In case you have any related questions please contact RJ-LASER. Exclusion of liability The AS 500 should only be used for the purpose described in these operating instructions. The manufacturer will not be liable for any damage or injuries resulting from usage not contained in these operating instructions. The manufacturer reserves the right to make modifications in keeping with technological advances. Safety standard The AS 500 is a high-quality laser device and meets the requirements of EN 60825-1 (Safety of Laser Devices), 93/68/EWG (EMC regulations). 3

Safety Precautions Caution - Using the operating equipment or settings in a way not described here can result in dangerous exposure to radiation. Shutdown in an emergency The laser can be shut down in the event of an emergency by pulling out the safety plug. Personnel The AS 500 should only be operated by trained personnel. The personnel must be instructed in safe handling procedures and also made aware of the potential risks of laser radiation. Radiation injuries Do not look directly into the laser beam outlet. Laser radiation can cause eye damage. The use of protection goggles are recommended. Treatment room The laser may only be operated in closed rooms. Safeguarding against unauthorized usage To safeguard against unauthorized usage, the AS 500 is equipped with a removable key, safety plug and safety code. The laser can only be operated when the key and safety plug is inserted or the code is activated. If the AS 500 laser is not being used, always remove the key and store it separately from the device to prevent unauthorized usage. Device out of use: If you assume that the device can not be used properly any more and could endanger user or patient, it should be set out of use and has to be transfered to the manufacturer or the authorized service station for repair. Such case could be e.g.: Visible damage of the housing of charger or main unit The device does not work properly The device was stored or transported under harmful conditions 4

Description of the Device / Proper Usage Technical data Laser therapy device AS 500 Laser class 3R Protection class IP 21 (drop proof) Absolute failure of the measurement of the laser 10% power Current supply charger Model FRIWO FW7555M/08 Weight 4 kg Dimensions (L x B x H) 35 x 11 x 29 cm Laser probe Wave length Output power Laser type Beam divergence 655 nm max. 5 mw Continuous (CW) 30 degrees Operating conditions Room temperature + 10 C to +40 C Relative humidity 30% to 75% Atmospheric pressure 700 hpa to 1060 hpa Transport and storage Room temperature -20 C to +40 C Relative humidity 30% to 75% Atmospheric pressure 700 hpa to 1060 hpa Content of delivery incl. charger, manual, laser probe. Manufacturer: REIMERS & JANSSEN GmbH, Frohnacker 8, 79297 Winden, Germany 5

Explanation of the pictograms IP21 Housing offers drop water protection Device type B (device offers safety against electric shock, especially in regard to leaking current) The device meets the requirements of EN 60825-1. Observe the instructions in the manual! Symbol for the laser beam: Warning for laser beam. Explanatory Label Symbol (International): " Visible and invisible laser radiation" including the standard which was used for the classification of the laser. Lable indicating power, wave length, diode type Combination of laser labels according to EN 60825-1: - Laser aperture and laser beam direction - Explanatory label 6

Funcional elements on the front panel and probe Key switch LED-Indicators Stand by Laser on (READY) Charge indicator Battery control Socket for laser probe Socket for Remote-Laser-Stop Button Stand by Laser on (READY) Button Timer Button Laser Start (L) (F) without function AS 500 in the closed case Side view with technical label and charge socket, counter. 7

LED-lamps Main unit LED Color Status Meaning STAND-BY green on Stand-by LASER on green on Laser is ready CHARGE green on Main unit is connected with the charger to the mains current supply, accumulator will be charged Battery low green on Accumulator will soon be empty, please charge. Probe Laser on green on Laser is ready Beam red on Iluminates the area to be radiated. Starting operation Placement of the unit Choose a strong and horizontal table to place the unit, if it is not in the portable use. Expand the legs to position the AS 500 in an optimal condition for the use. Key switch On the front panel you will find the lock for the key switch. The key switch is used to prevent the use of the laser to unauthorized persons. Inserting the safety plug (REMOTE LASER STOP) To safeguard against unauthorized use, the AS 500 is equipped with a removable safety plug. Insert the safety plug in the socket on the front panel. You can use the safety plug in contact to a foot switch or a door contact. Please ask your service for detailed instructions how to use the remote contact. Condition of the battery, charging the battery On the front panel you will find two LEDs above the name BATTERY. These LEDs indicate the condition of the battery and the charging period. If the green LED (L6) is shining, the battery is sufficiently charged. If the green LED extinguished and the red LED (L7) is active, please recharge the battery or use mains current supply. In order to charge the battery attach the charger into the socket of the mains supply and connect the plug with the socket (Power supply) at the rear panel of the AS 500. During charging the LED CHARGE (L8) will be active. The battery is fully charge when the LED is flashing. Please note that the battery can not be overcharged and the AS 500 can be used at any time during charging. 8

Operational modes The AS 500 will indicate 3 modes of operation: Standby, Ready. After switching on the AS 500 the condition of the battery and contact to the mains current supply will be checked, thereafter the AS 500 will control if any probe is connected and will identify the probe. Thereafter the unit will step into Stand-by mode. In the Stand-by mode you can carry out all settings. Stand-by: Stand-by LED is active, the laser can not be started. Leave the Stand-by mode by pressing the button Stand-by/Ready in order to reach the Ready mode. In the Ready mode you can start the laser beam. Laser Ready: Laser ON LED is active. You can now start the laser by pressing button L on the probe. Pressing Stand-by again will lead to the Stand-by mode. Power save: If the laser will not be started within 2 minutes the unit will step into the Stand-by mode and the display will shut off. Start of the Ready mode via the Stand-by/Rady button. 9

Before starting the therapy mode 1. Connect the laser probe to the socket and secure it with the nut. 2. Check if the safety plug is connected to the socket REMOTE LASER STOP. 3. Turn the key switch to position ON. Release of the laser beam Press STAND-BY/READY, the laser steps to LASER ON mode, the green LED on the probe and front panel is active. Pressing button [L] will release the laser beam. After the release the laser will shut of automatically once the pre-set therapy time expires. The laser can be stopped at any time by pressing the button [L] again. Time setting Press button [T] and the display will indicate the time in steps of 10 seconds (10, 20, 30, 40 seconds). When the time expired the laser will shut off. 10

Charging the battery The LED Battery low on the front panel indicate the condition of the battery. If the battery shall be charged the lamp will glow. Please note that you can charge the AS 500 can be connected to the mains current constantly and the battery can be charged at any time because it does not have a memory effect. For charging insert the plug of the charger into the socket on the back side of the casing and connect it with the mains supply. During the charging procedure the LED charge on the front panel will glow until the battery is fully charged. Socket for the charger (left side of the case) International plugs As an optional accessory you can use various interchangeable plugs corresponding to the international electric systems (Australia, USA, England, Europe). 11

Laser-protection goggles The only types of safety goggles which may be worn are those which meet DIN 58215 standards. The filter glasses effective wavelength range include the laser light wavelength of the AS 500 equipment in use. There are two types of safety goggles available: Number 530, which may be used for wavelengths from: 655 nm to 904 nm Cleaning / Disinfecting Please observe that cleaners for plastics, soap are used for periodic cleaning of the plastic parts. No penetrative or corrosive agents (such as acetone) should be used. Keep fluids from entering the housing. Standard disinfectants may be used. When this is done, the unit is to be wiped with a soft cloth which has been dampened with a mild, approved disinfectant (50% diluted propyl alcohol solution). The tip may be dipped into the solution. Under no circumstances is the unit to be flooded with the disinfectant or to be treated with solvents! Autoclaving must not be used on the unit. Maintenance/Calibration The laser diodes will be calibrated by the software at each start. RJ recommends an annual service of the laser at the RJ service facilities or an authorised service station. Always ensure that operational and sufficiently charged batteries are used. The interior of the AS 500 contains no elements or components which require servicing by the user. Therefore, there is no need to open the housing. To meet the requirements of DIN VDE 0837, Radiation safety for laser devices, we recomment the unit to be tested and recalibrate after one year of use to ensure that the laser is operating properly. Please send the unit to the manufacturer for testing and recalibration. Disposal Due to the hazards of laser beams, the AS 500 is not to be disposed of as standard electronic scrap. The device is to be delivered to either the supplier or to the manufacturer for proper disposal. Warranty There is a 2 years warranty from the manufacturer. The manufacturer guarantees operation of all AS 500 features described in the user s guide, provided the equipment is used in accordance with the instructions detailed in the user s guide and is treated with proper care. New settings, maintenance or repairs may only be performed by the manufacturer or an authorized workshop; otherwise the warranty is rendered null and void. Interventions in the device by third parties will lead to loss of warranty claims and will release the manufacturer from all product liability. 12

Distributed by Domburg & van Loon bv Modem 33 NL- 7741 AA Coevorden 13