Technika Światłowodowa R 05-092 omianki ko³o W-wy ul.kolejowa 14 tel/fax 48.22.7510292 tel 48.22.4982666 www. bobts.pl e.mail bobts@bobts.pl OPERATION MANUAL RECTOSCOP LED TYPE BOB R OM led Date of issue: Łomianki 22.01.2016
TABLE OF CONTENTS 1. Device designation... page 2 2. Specifications and symbols... page 2 3. Device construction... page 3 4. Safety and use... page 3 5. Operation... page 4 6. Cleaning... page 4 7. Possible damages and remedies... page 5 8. Repairs conditions... page 5 9. Inspections... page 5 10. Protection of the environment - recycling... page 5 Page 1
1.DEVICE DESIGNATION Rectoscopy portable type BOB - R OM LED is adapted for use with disposable tubes. It is a medical device designed for the diagnosis and treatment of diseases the anus, the rectum and the sigmoid colon. If you use disposable tubes it is recommended to use tubes of producers that have the marketing authorization: WING PLAST - Quality Medical Instruments: sigmoidoscopy tube with obturator diam. 20mm length 250mm - Ident. 1561 proctoscopy tube with obturator diam..20mm length 130mm - Ident. 1551 HEINE Optotechnik GmbH: sigmoidoscopy tube with obturator diam. 20mm length 250mm No. E-03.18.825 E-03.18.811 proctoscopy tube with obturator diam. 20mm length 130mm No. E-03.19.825 E-03.19.811 anoscopy tube with obturator diam. 20mm length 85mm No. E-03.19.925 E-03.19.911 The disposable tube is constructed in such a way, that the light emitted by the LED is transmitted to the rectoscopy head and next- through a bundle of optical fibers in the head -to the end of the tube, illuminating the field of view. 2.SPECIFICATIONS AND SYMBOLS BOB R OM- led Medical illuminator RECTOSCOPY HEAD LIGHT SOURCE POWER SUPPLY Light source - led diode - external diameter - magnifying eyepice - 30 mm - 1,5x LED DIODE - 5W Lithium-ion battery Type 18650 3400mAh 3,7V - lighting time 5 hour - charging time 10-12 hours Page 2
3.DEVICE CONSTRUCTION 1 2 3 4 5 L0 SN.L 2160 11 8 7 6 Rektoskop consists of: * Rectoscopy Head (1) with tightened to the device disposable tubes (2) and eyepiece (3) * Manual air pump (4) * LED light source buit-in permanently in the handle (5) with switch and light intensity adjustable(6) * 2 pieces of batteries * Battery Charger (8) 4.SAFETY AND USE DO NOT LEAVE THE BATTERY IN THE MACHINE WHEN IT IS NOT USED FOR A LONG TIME. discharged battery must be charged immediately. Do not modify without authorization of the manufacturer. If the device is modified, adequate inspection and testing should be made to ensure the safe continuity using of the device Page 3
5.OPERATION * Remove the battery tray (7) * Place the battery in the handle (5) * Connect the handle (5) to the rectoscopy head (1) * Disposable tube (2) screw onto the rectoscopy head (1) * Slide the rubber tubule of insufflation pump (4) onto the rectoscopy head connector * Holding the handle insert the obturator tube through a hole in the rectoscopy head (1) -strongly down to stop point. * Hold the obturator with thumb. * Turn the light source on. (6) * Rectoscopy is ready for application. * After applying remove the obturator and select required illuminance with the knob (6) * To the rectoscopy head (1) is attached the eyepiece (3), which is to seal optical fiber head and gives larger (1,5 x) image of observed field Charging the battery. To charge the battery:, unscrew the battery tray (7) holding the handle. Pass the battery to the charger (full charge of 10-12 hours). You must carefully mount a battery into the charger and validate the accordance with the designation (+), (-). 6.CLEANING The rectoscopy head - after separating it from the handle and a disposable tube must be cleaned immediately after use ( to prevent drying of the residue.) It is advisable to wash with a soft brush using soapy or pure water. If it is washed in a washing machine or with chemicals, follow the recommendations of the chemicals' manufacturer. Clean the polished outlets of the optical fibre bundles very carefully. The handle can be cleaned by washing it with a cloth with disinfectant. Do not clean with ultrasounds! After washing, rinse thoroughly with demineralised water and dry in max. 65 degrees C. Disinfection We advise soaking in a disinfectant or a thermochemical disinfection in max. 65 degrees C in a water steriliser. Strictly follow the disinfectant manufacturer's recommendations! Failure to follow the disinfectant manufacturer's recommendations may result in damaging of the rectoscope head. After disinfection, rinse with sterile demineralised water and dry thoroughly with a sterile gauze. Sterilization The head sterilization is not required for the diagnostic purposes application. After washing as described above, the head may be sterilized with ethylene oxide at a temperature of 65 degrees C. Autoclaving (type S or B) can be carried out under the conditions specified by the manufacturer. We do not recommend instant sterilization in an autoclave or sterilization with use of dry air. Page 4
7.POSSIBLE DAMAGES AND REMEDIES The device switched on; The device switched on; a lack of light; - discharged battery; to charge the battery a lack of light; - charged battery; repair service 8.REPAIR CONDITION Upon general terms, manufacturer provides 36-month guarantee starting at the date of purchase. Guarantee does not cover: - Mechanical damage to casing - Damage due to misuse of the illuminator After the guarantee period manufacturer provides paid service. Production and services: BOB Technika Światłowodowa 05-092 Łomianki near Warsaw, ul. Kolejowa 14, phone / fax 0 22 751 02 92, phone 0 22498 26 66 e-mail: bobts@bobts.plwww.bobts.pl Serial number Date and signature E 0003504W 9.INSPECTIONS Manufacturer expects the rectoscope's life to be 10 years. It is possible to extend the life by three more years ( upon positive inspections.) Obligation to make the inspections is imposed by the Medical Products Act of May 20, 2010, Journal of Laws No 107, item 679, art. 90, item 4 method and principles are set in the standard PN-EN 62353 "Electrical medical devices Periodical inspections and tests after repair of electrical medical devices". The following inspections are mandatory: 1. Before commissioning upon manufacturer's cost 2. After guarantee repair upon manufacturer's cost 3. After post-guarantee repair upon customer's cost Note that operation of device without valid periodical inspections infringes the Medical Products Act regulations and the Decision of the Ministry of Health "Medical Incident" (Journal of Laws 2011, No 33, item 167, February 02, 2011). 10.PROTECTION OF THE ENVIRONMENT-RECYCLING According to waste disposal act, Journal of Laws 2001.62.628 and Directive 91/689/EEC of the European Union it is forbidden to dispose electrical equipment to municipal dump. Customer is obliged to send used equipment to specialist company which will dispose of the equipment according to own or manufacturer's instruction. Page 5