U92-2RFID transponder reader device

Instructions for Use nGenius Universal Tracker REF 6000-014-000 2007-11-21 6000-014-700 Rev. B www.stryker.com CPT Use Only C www.stryker.com Intended Use The nGenius Universal Tracker is part of the Stryker Navigation System. It is used in combination with the Navigation System camera to track the position and orientation of instruments or rigid anatomical struc- tures to which the nGenius Universal Tracker may be attached via a pin or mechanical adapter. The medical purpose is determined by the application modules. Refer to the intended use of the relevant application module for detailed information. User/Patient Safety WARNINGS: • Read and understand this information. Familiar- ization with the Stryker Navigation System prior to use is important. Only trained personnel are to use this system. • The instruments should only be used in accor- dance with the instructions for use contained in this manual by authorized persons who have been fully trained in their safe and effective use. The failure to follow these instructions will void your warranty. • Prior to each use, instruments should be opera- ted and inspected for any loose components, da- mage or malfunction. DO NOT use if any of these conditions exist. Contact Stryker Navigation Service immediately in such case. See contact information in the address fi eld. • Do not service instruments. They contain no parts that the user can service. If service is re- quired, contact Stryker Navigation Customer Service. • Performing procedures with instruments other than those specifi ed in these instructions or out- side of their intended use compromises navigati- on accuracy. 1 Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany t: +49 761 4512-0 Distributed by: Stryker Navigation 4100 East Milham Avenue Kalamazoo, MI 49001 USA t: +1 269 323 7700 t: 800 253 3210 (toll-free within the US) • The health care provider performing any proce- dure is responsible for determining the appro- priateness of the instruments and the specifi c technique for each patient. Stryker, as a manuf- acturer, DOES NOT recommend surgical proce- dure. • Clean and sterilize the nGenius Universal Tracker before fi rst and every use as instructed in this manual. • This equipment is not suitable for use in the pre- sence of fl ammable anesthetic mixture with air or with oxygen or nitrous oxide. • Use Instrument Battery REF 6000-006-000 only. Load a new battery before fi rst and every use as instructed in this manual. Have several new bat- teries available. • Remove Instrument Battery before storing or sterilizing the nGenius Universal Tracker. • Prior to surgery, this equipment should be checked with the Stryker Navigation System to ensure that it is functioning properly. • During surgery, if fl uids such as saline solution enter the battery holder, the electronics can fail and communications with the system will cease. www.stryker.com CAUTIONS: • DO NOT apply any physical impact to the tracker, especially with a mallet or similar tool. Any impact will cause product damage or operational failure due to battery movement. • To avoid malfunction, DO NOT scratch or dama- ge the LEDs or photodiode covers in any way. 2 • Use only Stryker approved components and accessories, unless otherwise specifi ed. Other accessories may result in increased electroma- gnetic emissions or decreased electromagnetic immunity of the system. DO NOT modify any component or accessory. Failure to comply may result in patient and/or health care staff injury. • Ensure the line of sight between the tracker and the camera is NOT blocked. The infrared Light Emitting Diodes (LEDs) and photodiodes must be in view of the camera for the Navigation System to function properly. • Excessive infrared radiation from external sour- ces can infl uence localization of the instruments by the Navigation System. Refer to the Navigati- on System II-Camera Instructions For Use. • Mount and detach the tracker as instructed in this manual. • Attach the nGenius Universal Tracker only to devices with a generic interface pin (see fi gure 3). Refer also to the NavLock Instructions for Use REF 6000-999-700. • In case of the slightest suspicion of incompati- bility or risks, do not use the nGenius Universal Tracker. • Ensure the generic interface pin is fully inserted into the tracker ́s notch and snaps into position. • Take special precautions regarding electro- magnetic compatibility (EMC) when using this medical electronic equipment. Install and put the equipment into service according to the EMC in- formation in the EMC Specifi cations Manual REF 6000-005-760. This medical equipment meets all requirements in the EN/IEC 60601-1-2 standard and can be installed in a normal environment. The equipment must not be placed or installed close to strong electromagnetic sources which may infl uence the function of this equipment. • Prior to proceeding, verify that the nGenius Uni- versal Tracker is fi rmly attached to the instrument with no movement after attachment, as instructed in this manual. If the tracker moves relative to the instrument, navigation is inaccurate.Fixate the tracker again, recalibrate and re-validate the instrument. • To prevent incorrect treatment, regularly perform landmark tests. • Use the nGenius Universal Tracker only with instruments which have less then 250 mm tip offset. • Always validate the instrument after calibration. • Remove any NavLock / NavLock Lite adapter from both tracker and instrument before cleaning and sterilization. • Recalibrate the instrument, if the tracker with the instrument has been subjected to a shock. • Avoid placing fi ngers on or near the LED domes and keep other objects at least 25 mm away from the LED domes when tracking. www.stryker.com Troubleshooting Guidelines Green status light does not come on when battery is inserted: • Battery installed in wrong orientation. Reinstall. • Battery power low. Replace battery. • Tracke…

Text truncated - open the document above for the full version.

Annex B of test report R70573_A second version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue: 07 December 2007page1 of3 70573_6.jpgLightweight Tracker, 3-D-view 1 Annex B of test report R70573_A second version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue: 07 December 2007page2 of3 70573_7.jpgLightweight Tracker, 3-D-view 2 Annex B of test report R70573_A second version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue: 07 December 2007page3 of3 70573_5.jpgLightweight Tracker, transponder

Annex C of test report R70573_Asecond version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue:07 December2007page1 of4 70573_2.jpgLightweight Tracker, internal view Annex C of test report R70573_Asecond version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue:07 December2007page2 of4 70573_4.jpgLightweight Tracker, detail view to battery housing / antenna Annex C of test report R70573_Asecond version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue:07 December2007page3 of4 70573_3.jpgLightweight Tracker, PCB, top view Annex C of test report R70573_Asecond version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue:07 December2007page4 of4 70572_3.jpgLightweight Tracker, PCB, bottom view

Königswinkel 10 32825 Blomberg Germany Phone+49 5235 9500-0 Fax+49 5235 9500-10 TEST REPORT Test Report Reference: R70753_Asecond version Equipment under Test:Lightweight Tracker FCC ID:U92-2 IC:4919D-2 Serial Number: None Applicant:Stryker Leibinger GmbH & Co. KG Manufacturer: Stryker Leibinger GmbH & Co.KG Test Laboratory (CAB) accredited by DATech GmbH in compliance with DIN EN ISO/IEC 17025 under the Reg. No. DAT-P-105/99-21, FCC Test site registration number 90877 and Industry Canada Test site registration IC3469 TEST REPORT REFERENCE: R70573_Asecond version Examiner: Thomas KÜHNDate of issue:07 December2007Page2 of22 Contents:Page 1 IDENTIFICATION.....................................................................................................................................3 1.1APPLICANT.....................................................................................................................................3 1.2MANUFACTURER..........................................................................................................................3 1.3DATES.............................................................................................................................................3 1.4TEST LABORATORY......................................................................................................................4 1.5RESERVATION...............................................................................................................................4 1.6NORMATIVE REFERENCES..........................................................................................................4 1.7TEST RESULTS..............................................................................................................................4 2 TECHNICAL DATA OF EQUIPMENT......................................................................................................5 2.1DEVICE UNDER TEST...................................................................................................................5 2.2PERIPHERY DEVICES...................................................................................................................5 2.3SPECIAL EMC MEASURES...........................................................................................................5 3 OPERATIONAL STATES AND PHYSICAL BOUNDARIES.....................................................................6 4 ADDITIONALINFORMATION..................................................................................................................7 5 APPLICATION OVERVIEW.....................................................................................................................7 6 METHOD OFMEASUREMENT...............................................................................................................8 6.1RADIATED EMISSIONS 9kHz to 30 MHz ......................................................................................8 6.2RADIATED EMISSIONS 30 MHz to 1 GHz .....................................................................................10 7 TEST RESULTS EMISSION TEST..........................................................................................................13 7.1PRELIMINARY RADIATED EMISSION TEST (9k Hz to 30 MHz) ..................................................13 7.2PRELIMINARY RADIATED EMISSION TEST (30 MHz to 1 GHz) .................................................15 7.3FINALRADIATED EMISSIONTEST (9k Hz to 30 MHz) ................................................................17 8 TEST EQUIPMENT AND ANCILLARIES USED FOR TESTS.................................................................18 9 LIST OF ANNEXES..................................................................................................................................22 TEST REPORT REFERENCE: R70573_Asecond version Examiner: Thomas KÜHNDate of issue:07 December2007Page3 of22 1 IDENTIFICATION 1.1APPLICANT Name:Stryker Leibinger GmbH & Co. KG Address:Bötzinger Strasse 41 79111 Freiburg Country:Germany Name for contact purposes:Mr. Hans-Paul ARNDT Tel:+ 49 761 45 12-464 Fax:+ 49 761 45 12-44 94 64 e-mail address:[email protected] 1.2MANUFACTURER Name:Stryker Leibinger GmbH & Co. KG Address:Bötzinger Strasse 41 79111 Freiburg Country:Germany Name for contact purposes:Mr. Hans-Paul ARNDT Tel:+ 49 761 45 12-464 Fax:+ 49 761 45 12-44 94 64 e-mail address:[email protected] 1.3DATES Date of receipt of test sample:23 May 2007 Start of test:23 May 2007 Finish of test:15 June 2007 TEST REPORT REFERENCE: R70573_Asecond version Examiner: Thomas KÜHNDate of issue:07 December2007Page4 of22 1.4TEST LABORATORY The tests were carried out at:PHOENIX TESTLAB GmbH Königswinkel 10 D-32825 BlombergPhone:+49 (0) 52 35 / 95 00-0 GermanyFax:+49 (0) 52 35 / 95 00-10 accredited by DATech GmbH in compliance with DIN EN ISO/IEC 17025 under Reg. No. DAT-P-105/99-21, FCC Test site registration number 90877 and Industry Canada Test site registration IC3469 Test engineer:Thomas KÜHN07 December2007 NameSignatureDate Test report checked:Frank EIKERMANN07 December2007 NameSignatureDate Stamp 1.5RESERVATION T h i s t e s t r e p o r t i s o n l y v a l i d i n i t s o r i g i n a l f o r m . Any reproduction of its contents without written permission of the accredited test laboratory PHOENIX TESTLAB GmbH is prohibited. The test results herein refer only to the tested sample. PHOENIX TESTLAB GmbH is not responsible for any generalisations or conclusions drawn from these test results concerning further samples. Any modification of the tested samples is prohibited and leads to the invalidity of this test report. Each page necessarily contains the PHOENIX TESTLAB Logo and the TEST REPORT REFERENCE. 1.6NORMATIVE REFERENCES [1]ANSI C63.4-2003AmericanNational Standard for Methods of Measuring of Radio-Noise Emissions from Low- Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. [2]FCC 47 C…

Text truncated - open the document above for the full version.

Annex A of test report R70573_B second version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue: 07 December 2007page1 of3 70573_k.jpgLightweight Tracker,test set-up fully anechoic chamber Annex A of test report R70573_B second version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue: 07 December 2007page2 of3 70573_j.jpgLightweight Tracker, test set-up fully anechoic chamber Annex A of test report R70573_B second version EUT: Lightweight Tracker Manufacturer: Stryker Leibinger GmbH & Co. KG Examiner: Thomas KÜHNDate of issue: 07 December 2007page3 of3 70573_g.jpgLightweight Tracker,test set-up fully anechoic chamber