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Storz 40712035, Instructions For Use Manual

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Preparation

Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR

24

4.

Release the lock.

ð

The sinus burr is locked in place.

5.

Check that it is firmly in place by gently pulling the adjustment wheel axially.

6.

Check the rotating function by rotating the adjustment wheel.

Summary of Contents for 40712035

Page 1: ...Instructions for use DRILLCUT X II DRILLCUT X II 35 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: ...h delivery 16 4 7 Possible combinations 16 4 8 Technical data 17 4 9 Storage and usage conditions 17 5 Preparation 19 5 1 Unpacking the product 19 5 2 Assembling the handle optional 19 5 3 Connecting...

Page 4: ...levels for proximity fields from HF wireless communications equipment 33 11 5 Table 3 Test levels for radiated and conducted immunity tests 34 11 6 Table 4 Emission class and group 35 11 7 Table 5 Rec...

Page 5: ...for use of the combinable products carefully and follow all the safety notes and warnings 1 3 Scope These instructions for use are valid for Product name Item number DRILLCUT X II 35 shaver handpiece...

Page 6: ...erventions in ENT surgery and plastic procedures for controlled excision morcellation removal ablation and transection of bone tissue Ablation of solid adenoidal masses Rhinoplasty Resection of soft a...

Page 7: ...Normal use Instructions for use DRILLCUT X II DRILLCUT X II 35 WWK497_EN_V1 0_03 2020_IFU_CE MDR 7 2 7 Patient population There are no restrictions in terms of patient groups for this product...

Page 8: ...d before and after every subsequent use using validated procedures WARNING Before using the system the user must ensure that the individual system components are functioning correctly and reliably and...

Page 9: ...ature of the handpiece Always work with suction and irrigation WARNING When using rotating instruments ensure that the instruments are sufficiently irrigated and cooled Inadequate irrigation can resul...

Page 10: ...WARNING Always keep a spare device at hand in case the first device fails WARNING Do not open the device Arrange for service work to be carried out by the manufacturer or by personnel authorized by th...

Page 11: ...11 3 5 6 7 8 9 10 12 1 DRILLCUT X II handpiece 7 Connector 2 Lock blade mount 8 Handle 3 Guide grooves for the handle 9 Rotating wheel 4 Irrigation port 10 Connectors for guide grooves 5 Suction devic...

Page 12: ...ions for use DRILLCUT X II DRILLCUT X II 35 WWK497_EN_V1 0_03 2020_IFU_CE MDR 12 curved 35 40 curved 65 Single use shaver attachments applied parts straight curved 35 40 curved 65 Single use sinus bur...

Page 13: ...11 12 1 DRILLCUT X II 35 handpiece 7 Connector 2 Lock blade mount 8 Handle 3 Guide grooves for the handle 9 Rotating wheel 4 Irrigation port 10 Connectors for guide grooves 5 Suction device 11 Clampin...

Page 14: ...LLCUT X II DRILLCUT X II 35 WWK497_EN_V1 0_03 2020_IFU_CE MDR 14 curved 40 curved 40 curved 70 Reusable shaver attachments applied parts straight curved 35 40 curved 65 Single use shaver attachments a...

Page 15: ...on the packaging Symbol Meaning Manufacturer Date of manufacture Unique Device Identifier Consult instructions for use Keep dry Do not use if package is damaged Temperature limit Humidity limit Air pr...

Page 16: ...250 RA or DRILLCUT X II 35 shaver handpiece model 40712035 with integrated connecting cable Cleaning adaptor 41250 RA Optional accessories Handle adjustable model 40712090 for use with all DRILLCUT X...

Page 17: ...um speed 4000 rpm Rotation mode Oscillation Shaver rotation speed DRILLCUT X II 35 Minimum speed 900 rpm Maximum speed 10 000 rpm Start up maximum speed 4000 rpm Rotation mode Oscillation Sinus burr 1...

Page 18: ...497_EN_V1 0_03 2020_IFU_CE MDR 18 Storage transport conditions Temperature 20 C to 60 C Relative humidity non condensing 20 to 95 Air pressure 500 hPa 1 080 hPa Usage conditions Temperature 10 C to 30...

Page 19: ...sport 5 2 Assembling the handle optional NOTICE Turning the rotating wheel clockwise when the handle is disassembled can damage the seal Do not turn the rotating wheel clockwise while the handle is di...

Page 20: ...ite The suction and irrigation tubes must be connected to the respective suction irrigation pump Observe the instructions for use for the device used 1 Connect the irrigation tube to the shaver handpi...

Page 21: ...h Ensure that the cutting window of the inner sheath is aligned with the orientation pin of the adjustment wheel 1 Insert the inner sheath into the outer sheath from behind 2 Pull back and hold the lo...

Page 22: ...Assembling the single use shaver attachments WARNING Risk of infection Unsterile instruments Check the packaging for damage and to ensure the expiration date has not passed If the expiration date has...

Page 23: ...sure the expiration date has not passed If the expiration date has passed or if the packaging is damaged dispose of the instruments Do not remove the instrument from the packaging until immediately be...

Page 24: ...ILLCUT X II 35 WWK497_EN_V1 0_03 2020_IFU_CE MDR 24 4 Release the lock The sinus burr is locked in place 5 Check that it is firmly in place by gently pulling the adjustment wheel axially 6 Check the r...

Page 25: ...k of burns A system that is not operated intermittently when working with the motor or handpiece can increase the instrument handpiece and motor temperature Checking the system combination before use...

Page 26: ...II DRILLCUT X II 35 and release the lock again 3 Remove the suction tube from the suction port on the DRILLCUT X II DRILLCUT X II 35 4 Remove the irrigation tube from the irrigation port of the DRILL...

Page 27: ...0_03 2020_IFU_CE MDR 27 2 Remove the handle from the handpiece by pushing it axially over the guide grooves NOTICE Turning the rotating wheel clockwise when the handle is disassembled can damage the s...

Page 28: ...ARL STORZ The interventions described in this instruction manual are exempt from this rule Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries Contaminate...

Page 29: ...arts 9 1 Recommended accessories not included with delivery Shaver blades applied parts straight 35 curved 65 curved non serrated single serrated double serrated reusable or disposable sterile pack of...

Page 30: ...ug is not prop erly connected to the socket on the device Push the power supply plug firmly into the socket on the device Defective power cord Replace power cable Instruments do not rotate Connection...

Page 31: ...easures such as relocating or re orienting the product The emission characteristics of this product make it suitable for use in professional healthcare facilities as well as in a residential environme...

Page 32: ...tions and voltage variations acc to IEC 61000 4 11 Voltage dip Dip to 0 for 1 cycle at 0 phase angle Dip to 70 for 25 30 cycles at 0 phase an gle Dropout to 0 for 0 5 cycles 0 45 90 135 180 225 270 a...

Page 33: ...ty fields from HF wireless communications equipment Test fre quency MHz Frequency band MHz Radio service Modulation Immunity test level V m Compliance level V m 385 380 390 TETRA 400 Pulse modula tion...

Page 34: ...HF communications equip ment should be used no closer to any part of the product including cables than the recommended separation distance calcu lated from the equation applicable to the fre quency of...

Page 35: ...4 Emission class and group Guidelines and manufacturer s declaration electromagnetic emissions The product is intended for use in such an environment as specified below The customer or user of the dev...

Page 36: ...12 23 For transmitters whose maximum rated power is not listed in the table above the recom mended separation distance d in meters m can be estimated using the equation from the re spective column wh...

Page 37: ...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 59 Lenk...

Page 38: ...807 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 STORZ Endosc...

Page 39: ...Subsidiaries Instructions for use DRILLCUT X II DRILLCUT X II 35 WWK497_EN_V1 0_03 2020_IFU_CE MDR 39...

Page 40: ...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 WWK497 EN V1 0 03 2020 IF...

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