YMQ-8066000Laboratory Equipment with RFID

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Philips minicare analyzer INSTRUCTIONS FOR USE Release 1.0 English P h i l i p s E l e c t r o n i c s N e d e r l a n d B . V . [ 1 2 n c x x x x x x x x x x x ] [ D r a f t v e r s i o n 0 . 2 T h i s l a b e l w i l l b e r e m o v e d ] 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Published by Philips Electronics Nederland B.V. Philips Electronics Nederland B.V. reserves the right to make changes to both this document and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this document is intended as any offer, warranty, promise or contractual condition, and must not be taken as such. © Koninklijke Philips Electronics N.V. 2011 All Rights are reserved. Reproduction in whole or in part in any form or by any means, electrical, mechanical or otherwise is prohibited without the written consent of the copyright holder. Issue Number [12nc xxxx xxx xxxx] [Draft version 0.2 This label will be removed] Philips Electronics Nederland B.V. acting through Healtcare Incubator High Tech Campus 5 5656 AE Eindhoven The Netherlands Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Philips Electronics Nederland B.V. to provide accurate and up-to-date information to users. Non-Philips product names may be trademarks of their respective owners. Published in The Netherlands. 0-2 Philips minicare analyzerRelease 1.0 P h i l i p s E l e c t r o n i c s N e d e r l a n d B . V . [ 1 2 n c x x x x x x x x x x x ] [ D r a f t v e r s i o n 0 . 2 T h i s l a b e l w i l l b e r e m o v e d ] 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Contents Introduction..............................................................................................11-1 1.1About the Philips minicare system.............................................1-1 1.2About these Instructions for Use................................................1-2 1.3Intended use..............................................................................1-3 1.4Compatibility............................................................................1-3 1.5Compliance...............................................................................1-4 1.6European authorized representative...........................................1-4 1.7Training....................................................................................1-5 Safety.........................................................................................................22-1 2.1Important safety directions........................................................2-1 2.2Emergency procedures...............................................................2-2 2.3Explosion safety.........................................................................2-2 2.4Electromagnetic Compatibility (EMC)......................................2-3 2.5Labels and symbols....................................................................2-4 2.5.1minicare analyzer label.................................................2-4 2.5.2minicare docking station label......................................2-5 2.5.3Symbols.......................................................................2-6 Installation................................................................................................33-1 3.1Equipment overview..................................................................3-1 3.1.1Equipment connections...............................................3-2 3.2Action upon delivery.................................................................. 3-4 3.3Site preparation.........................................................................3-4 Philips minicare analyzerRelease 1.0 Contents 0-3 P h i l i p s E l e c t r o n i c s N e d e r l a n d B . V . [ 1 2 n c x x x x x x x x x x x ] [ D r a f t v e r s i o n 0 . 2 T h i s l a b e l w i l l b e r e m o v e d ] 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 3.4Storage and handling.................................................................3-5 3.4.1Environmental conditions............................................3-5 3.4.2Battery care..................................................................3-6 3.4.3Dust............................................................................. 3-6 System overview......................................................................................44-1 4.1Theory of operation...................................................................4-1 4.2Performance and limitations......................................................4-3 4.2.1Performance characteristics..........................................4-3 4.2.2Limitations of use........................................................4-4 4.3Preparation prior to use.............................................................4-4 4.4Installing the data manager software..........................................4-4 4.5Docking and undocking the minicare analyzer..........................4-5 4.5.1Docking the minicare analyzer.....................................4-5 4.5.2Undocking the minicare analyzer.................................4-6 4.6Configuring analyzer connectivity.............................................. 4-7 4.6.1Configuring the minicare analyzer with a static IP address.........................................................................4-7 4.6.2Configuring the minicare analyzer with a DHCP server …

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Request for Confidentiality Date: 11.12.2012 Subject: Confidentiality Request for: FCC ID: YMQ-8066000 IC: 9914A-8066000 ______ Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Permanent* 1 Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term Permanent Schematics Short Term Test Setup Photos Short Term Permanent* User’s Manual *Note: ______(Insert Explanation as Necessary)______ LRE Medical GmbH Esterline Corporation has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of (0) days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications: The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Sincerely, By: Manager Certification Thomas Ring 1 - The asterisked items (*) require further justification before permanent confidentiality will be allowed. These also currently require review by the FCC under their Permit-But-Ask policy before the grant is issued and can delay completion of an application. Further justification should be added to the note above. One such example for a potted device would be: “The EUT is FULLY potted using a non-removable epoxy based material. Removal of potting material causes irreparable damage to internal circuitry. See photographs exhibits that outline the device before and after potting.”

FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 26 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 7 At t a c h m e n t A 7.1 Photo documentation of the EUT – external photos FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 27 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 28 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009

1. BACK PLATE IMAGES FOR ANALYZER Example of back plate image Example of image inside battery compartment

FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 29 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 7.2 Photo documentation of the EUT – internal photos FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 30 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 31 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 32 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 33 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 34 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 35 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 36 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 37 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 38 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009

FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 1 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 EMI − T E S T R E P O R T - FCC Part 15.225 - Test Report No. : T35489-03-01KG 29. November 2012 ______________________________________________________________________________________________ Date of issue Type / Model Name : Minicare Analyzer R1.0 / 8066000 Product Description : Laboratory Equipment with RFID Applicant : LRE Medical GmbH Esterline Corporation Address : Hofer Strasse 5 86720 Nördlingen, Germany Manufacturer : LRE Medical GmbH Esterline Corporation Address : Hofer Strasse 5 86720 Nördlingen, Germany Licence holder : Philips Electronics Nederland B.V. Address : High Tech Campus 29 5656 AE Eindhoven, The Netherlands Test Result according to the standards listed in clause 1 test standards: POSITIVE The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permission of the test laboratory. FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 2 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 Contents 1 TEST STANDARDS 3 2 SUMMARY 4 3 EQUIPMENT UNDER TEST 5 3.1 Photo documentation of the EUT – See attachment A 5 3.2 Power supply system utilised 5 3.3 Short description of the equipment under test (EUT) 5 4 TEST ENVIRONMENT 6 4.1 Address of the test laboratory 6 4.2 Environmental conditions 6 4.3 Statement of the measurement uncertainty 6 4.1 Measurement Protocol for FCC, VCCI and AUSTEL 7 5 TEST CONDITIONS AND RESULTS 8 5.1 Conducted emissions 8 5.2 Field strength of the fundamental wave 12 5.3 Spurious emissions 14 5.4 Frequency tolerance 16 5.5 20 dB Bandwidth 18 5.6 Transmitter spectrum mask 21 5.7 Receiver radiated emissions 24 6 USED TEST EQUIPMENT AND ACCESSORIES 25 7 Attachment A 26 7.1 Photo documentation of the EUT – external photos 26 7.2 Photo documentation of the EUT – internal photos 29 FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 3 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 1 TEST STANDARDS The tests were performed according to following standards: FCC Rules and Regulations Part 15, Subpart A - General (September, 2011) Part 15, Subpart A, Section 15.31 Measurement standards Part 15, Subpart A, Section 15.33 Frequency range of radiated measurements Part 15, Subpart A, Section 15.35 Measurement detector functions and bandwidths Part 15, Subpart A, Section 15.38 Incorporation by reference FCC Rules and Regulations Part 15, Subpart C - Intentional Radiators (September, 2011) Part 15, Subpart C, Section 15.203 Antenna requirement Part 15, Subpart C, Section 15.204 External radio frequency power amplifiers and antenna modifications Part 15, Subpart C, Section 15.205 Restricted bands of operation Part 15, Subpart C, Section 15.207 Conducted limits Part 15, Subpart C, Section 15.209 Radiated emission limits, general requirements Part 15, Subpart C, Section 15.215 Additional provisions to the general radiated emission limitations Part 15, Subpart C, Section 15.225 Operation within the band 13.110 - 14.010 MHz FCC Rules and Regulations Part 1, Subpart I - Procedures Implementing the National Environmental Policy Act of 1969 Part 1, Subpart I, Section 1.1310 Radiofrequency radiation exposure limits Part 1, Subpart 2, Section 2.1093 Radiofrequency radiation exposure evaluation: portable device OET Bulletin 65, 65A, 65B, 65C Edition 97-01, August 1997 – Evaluating Compliance with FCC Guidelines for Human Exposure to Radio Frequency Electromagnetic Fields. ANSI C63.4: 2009 Methods of Measurement of Radio-Noise Emissions from Low- Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. ANSI C95.1:1992 IEEE Standard for Safety Levels with respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz CISPR 16-4-2: 2003 Uncertainty in EMC measurement FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 4 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 2 SUMMARY GENERAL REMARKS: The EuT is a Laboratory Equipment including a RFID identification working at 13.56 MHz. This test report describes the assessment for the RFID Module only. The receiver is permanently co-located within the transmitter. Therefore the receive mode is to short and was tested together with the transmitter in operating mode. There is no standby mode. FINAL ASSESSMENT: The equipment under test fulfills the EMI requirements cited in clause 1 test standards. Date of receipt of test sample : acc. to storage records Testing commenced on : 23. August 2012 Testing concluded on : 31. August 2012 Checked by: Tested by: Thomas Weise Dipl. Ing.(FH) Laboratory Manager Klaus Gegenfurtner Dipl.-Ing.(FH) FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 5 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 3 EQUIPMENT UNDER TEST 3.1 Photo documentation of the EUT – See attachment A 3.2 Power supply system utilised Power supply voltage : Battery 14.4 VDC 3.3 Short description of the equipment under test (EUT) The RFID Module is included the laboratory device, a so called “blood reader”. In the application communication takes place at 13.56 MHz and TAGs will be read over a distance of at least 6 cm. Number of tested samples: 1 Serial number: 000002012 EUT operation mode: The equipment under test was operated during the measurement under the following conditions: - TX pulsed modulated at 13,56 MHz EUT configuration: (The CDF filled by the applicant can be viewed at the test laboratory.) The following peripher…

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FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 8 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 5 T E S T C O N D I T I O N S A N D R E S U L T S 5.1 Conducted emissions For test instruments and accessories used see section 6 Part A 4. 5.1.1 Description of the test location Test location: Shielded Room S2 5.1.2 Photo documentation of the test set-up 5.1.3 Applicable standard According to FCC Part 15, Section 15.107(a): Except for Class A devices, for equipment that is designed to be connected to the public utility (AC) power line, the radio frequency voltage that is conducted back onto the AC power line on any frequency or frequencies within the band 150 kHz to 30 MHz shall not exceed the given limits. 5.1.4 Description of Measurement The measurements are performed following the procedures set out in ANSI C63.4 described under item 4.4.3. If the minimum limit margin appears to be less than 20 dB with a peak mode measurement, the emissions are remeasured using a tuned receiver with quasi-peak and average detection and recorded on the data sheets. FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 12 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 5.2 Field strength of the fundamental wave For test instruments and accessories used see section 6 Part CPR 1. 5.2.1 Description of the test location Test location: OATS1 Test distance: 3 metres 5.2.2 Photo documentation of the test set-up FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 14 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 5.3 Spurious emissions For test instruments and accessories used see section 6 Part SER 1, SER 2. 5.3.1 Description of the test location Test location: OATS1 Test distance: 3 metres 5.3.2 Photo documentation of the test set-up FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 16 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 5.4 Frequency tolerance For test instruments and accessories used see section 6 Part FE. 5.4.1 Description of the test location Test location: AREA4 (Climatic Chamber) 5.4.2 Photo documentation of the test set-up 5.4.3 Applicable standard According to FCC Part 15, Section 15.225(e): The frequency tolerance of t he carrier signal shall be maintained within ±0.01 % of the operating frequency over a temperature range of -20 °C to +50 °C at normal supply voltage and for a variation in the primary supply voltage from 85 % to 115 % of the rated supply voltage at a temperature of 20 °C. For battery operated equipment, the equipment shall be performed using a new battery. 5.4.4 Description of Measurement The frequency tolerance has been measured radiated using a spectrum analyser. The center frequency of the spectrum analyser has been set to the fundamental frequency. This is an alternative test method because the EuT can not be operated in un-modulated mode. The limit line was set to 10 dB below the carrier. The frequencies of the upper (f U ) and lower (f L ) points, where the displayed power envelope of the modulation including frequency drift is equal to the appropriate level, have been recorded. The centre frequency is calculated as f C = (f U + f L )/2. The measurement has been performed at normal and extreme test conditions from -20 °C to +50 °C in steps of 10 degrees (According to FCC Part 2.1055). FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 18 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 5.5 20 dB Bandwidth For test instruments and accessories used see section 6 Part MB. 5.5.1 Description of the test location Test location: AREA4 5.5.2 Photo documentation of the test set-up 5.5.3 Applicable standard According to FCC Part 15C, Section 15.215(c): Intentional radiators operating under the alternative provisions to the general emission limits, as contained in section 15.217 to 15.257, must be designed to ensure that the 20 dB bandwidth of the emission is contained within the frequency band designated in the rule section under which the equipment is operated. The requirement to contain the designated bandwidth of the emission within the specified frequency band includes the effects from frequency sweeping, frequency hopping and other modulation techniques that may be employed. FCC ID: YMQ-8066000 mikes-testingpartners gmbh File No. T35489-03-01KG, page 21 of 38 Ohmstrasse 2-4  94342 STRASSKIRCHEN  GERMANY Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 5.6 Transmitter spectrum mask For test instruments and accessories used see section 6 Part MB. 5.6.1 Description of the test location Test location: AREA4 5.6.2 Photo documentation of the test set-up