Storz 11301D4 Instructions For Use Manual Download Page 22

Page: 22 / 24

Subsidiaries

Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CE-
MDR

Summary of Contents for 11301D4

Page 1: ...Instructions for use LED battery light source with fast screw thread en...

Page 2: ...illustrations product descriptions and texts are the intellectual property of KARL STORZ SE Co KG Their use and reproduction by third parties require the express approval of KARL STORZ SE Co KG All ri...

Page 3: ...8 4 4 Symbols employed 9 4 4 1 Symbols on the packaging 9 4 4 2 Symbols on the product 10 4 5 Ambient conditions 10 5 Preparation 11 5 1 Unpacking the product 11 5 2 Testing the product 11 5 3 Assemb...

Page 4: ...suitability of the products for the planned procedure prior to use 1 2 Scope These instructions for use are valid for the following products Product Article number LED battery light source 11301D4 1 3...

Page 5: ...or skull base surgery Ear diagnostics and ear surgery Adenotomy tonsillectomy tracheotomy Laryngoscopy endolaryngeal microlarynx and transoral microsurgery Esophagoscopy diverticuloscopy 2 3 Contraind...

Page 6: ...rocedure prior to use Do not overload the product with mechanical stress Check the product for the following points before and after every use Completeness Good working order Rough surfaces left inadv...

Page 7: ...on suitable instruments and devices can result in uncontrolled behavior and injury to patients users and third parties Only combine the device with instruments and equipment that are approved for join...

Page 8: ...4 2 Possible combinations The battery light sources can be used with the following components Batteries Panasonic CR123A with UL Recognized Component Mark UR Duracell DL123A with UL Recognized Compon...

Page 9: ...no Batch code Medical device US Federal law 21 CFR 801 109 restricts this device to sale to or on the order of a licensed physician Manufacturer Date of manufacture Unique Device Identifier CE confor...

Page 10: ...o not dispose of in household refuse CE conformity mark With this mark the manufacturer declares the compliance of the prod ucts with the applicable regulation EU 2017 745 A code number after the CE m...

Page 11: ...In the case of damage hidden defects and short deliveries document their nature and extent and contact the manufacturer or supplier immediately 5 2 Testing the product 1 Inspect the product for visibl...

Page 12: ...milar objects immediately after use WARNING High light intensity Danger of glare The high light intensity of the light source can permanently damage eyes and cause blindness Never look directly into t...

Page 13: ...wise and remove the lid 3 Remove the old batteries and insert two new batteries Both batteries must always be replaced at the same time 4 Replace the lid and turn the lock clockwise as far as it will...

Page 14: ...send back contaminated products 7 3 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment WEEE Within the scope of application of th...

Page 15: ...duct should make sure that it is used in such an environment Interference im munity tests EN IEC 60601 test level Compliance level Electromagnetic envi ronment Guidelines Electrostatic dis charge ESD...

Page 16: ...to ensure that it is sufficiently low Immunity test acc to IEC 61000 4 3 for high frequency electromagnetic fields 3 V m 80 MHz to 2 7 GHz Refer to Table 2 for wireless proximity RF field test levels...

Page 17: ...s intended for use in the electromagnetic environment specified below The user of the product should make sure that it is used in such an environment Interference immunity tests EN IEC 60601 test leve...

Page 18: ...ment due to fixed transmitters an electromagnetic site survey should be considered If the measured field strength at the location where the device is used exceeds the above compli ance levels the devi...

Page 19: ...HF communications equipment transmitters and the product as recommended below according to the output energy of the communications equipment Rated power of the transmitter W Separation distance d m ac...

Page 20: ...storz se KARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 Email asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office K stu io st...

Page 21: ...om 1805 1807 Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 Email info karlstorz com cn KARL STO...

Page 22: ...Subsidiaries Instructions for use LED battery light source with fast screw thread KCC914_EN_V1 0_11 2020_IFU_CE MDR 22...

Page 23: ...Subsidiaries Instructions for use LED battery light source with fast screw thread KCC914_EN_V1 0_11 2020_IFU_CE MDR 23...

Page 24: ...RZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone 49 7461 708 0 Fax 49 7461 708 105 E mail info karlstorz com www karlstorz com KCC914 EN V1 0 11 2020 IF...