Table of Contents
Summary of Contents for Rexxam XL-1
- Page 1 LED Slit Lamp XL-1 Instruction for use The electronic data of the Instruction for use can be viewed on Ohira's web site. The contents of this Instruction for use may be changed without prior notice. D10S053en Revision 0 2021.05.13...
- Page 2 When a trouble and/or damage occurs caused by the maintenance and/or repair conducted by a person other than Ohira or the dealer specified by Rexxam. The trouble and/or damage of Ohira device caused by the device of other manufacturer not delivered by Ohira.
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Page 3: Table Of Contents
Contents PURPOSE OF USE ..........................1 DEFINED INTENDED USAGE ......................1 INTENDED USER, PATIENT POPULATION ................... 1 ACCESSORIES ............................. 1 INDICATIONS AND GRAPHIC SYMBOLS FOR SAFE USE ............1 PRECAUTIONS FOR USE........................3 WARNING DISPLAY AND POSITION ....................4 ASSEMBLY PROCEDURE ........................4 MAINTENANCE ........................... -
Page 4: Purpose Of Use
Make a magnified observation by. 3. Intended user, patient population This device (XL-1) is a medical electrical device. When using this device, please use it under the guidance of a doctor. Patients undergoing medical examination with this device (XL-1) should follow the instructions below. - Page 5 Symbol Description Manufacturer CE mark Serial number Authorised Representative in the European Community Medical Device Separate collection for waste of electrical and electronic equipment Consult instruction for use 「UDI-DI」 4571260230514 Symbol displayed on the packing box Symbol Description Fragile, handle with care This way up Stacking limit by number Keep away from rain...
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Page 6: Precautions For Use
6. Precautions for use Warning If something goes wrong (abnormal noise, smoke, etc.), immediately remove the battery from the device and contact your dealer. Continued use may cause fire or injury. If you experience any abnormalities such as smoke or a strange odor while charging the battery, stop charging and unplug the power plug from the outlet. -
Page 7: Warning Display And Position
Degree of protection against electric shock: Type B applied part. 8. Assembly procedure Take out the carrying case from the outer box. Remove the XL-1 device, diopter adjustment bar, forehead support, battery, etc. from the carrying case. Attach the forehead support to the binocular microscope. -
Page 8: Specifications
If the forehead support becomes dirty, wipe it with a neutral detergent. When reusing, disinfect the forehead support that the subject comes in contact with rubbing alcohol. If fingerprints, dust, etc. adhere to optical parts such as lenses, it will affect the observation. If it gets dirty, wipe it gently with a soft cloth. -
Page 9: Environmental Conditions
11. Environmental conditions Environmental conditions of use Temperature : 10°C to 35°C Humidity : 30% to 90% (No condensation) Storage conditions Temperature : -10°C to 55°C Humidity : 10% to 95% (No condensation) Transport conditions Temperature : -40°C to 70°C Humidity : 10% to 95% (No condensation) 12. - Page 10 2-4-2 Kanda-Tsukasa-machi, Chiyoda-ku, Tokyo,101-0048 Japan TEL: +81-3-6262-9471 FAX: +81-3-6262-9472 E-mail: eye@rexxam.co.jp URL: http://www.rexxam.co.jp Sales license number: 4501011300048 EU Authorised representative: Rexxam Co., Ltd. Netherlands Office Steenovenweg 5, 5708HN Helmond, The Netherlands Tel: +31 6 51939253 E-mail: David-klooster@rexxam.co.jp SRN: NL-AR-000002643 Manufacturer: Ohira Co., Ltd.
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