R3ZRTX3320RTX3320 � Wireless Telehealth Gateway

FUNCTIONALITY CALL FOR SERVICE: WIRELESS TELEHEALTH GATEWAY RTX 3320 RTX3320: The RTX3320 Wireless Telehealth Gateway is used for wireless reception of measurements taken by on-site patient monitors such as a wireless blood pressure monitor or a wireless personal weight scale. When the Gateway has received the measured values, it generates a call and conveys the data to a remote facility via a public telephone line. In some cases the Gateway is programmed to deliver data at a specific time of day. The delivery of data will automatically be repeated if the attempt to deliver data fails. The Gateway works in fully automatic mode, and requires no user action. Cleaning and Maintenance The Gateway may be cleaned with a soft, dry cloth or a cloth dampened with tap water and a mild detergent. A household glass cleaner on a soft, dry cloth may be used to clean off smudges. Never use any solvent, thinner, lighter fluid, alcohol, wet wipes or similar products on the Gateway. NOTE This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a par- ticular installation. If this equipment does cause harmful interference to radio or televi- sion reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by this companycould void the user's authority to operate the equipment. This device is for use at home. Power requirements Mains:100-240 VAC, 50-60Hz, 200 mA, Class II, No applied part. Only use the original power supply adapter with the type. designation FW7333M/06. Range of temperatures Operating10° C to 40°C / 50° to 104° F. Storage:-10° C to +45°C / 14° to 114° F. Transport:-20° C to +60°C / -4° to 140° F. Relative humidity Operating:10% to 90% non-condensing. Storage/Transport: 10% to 95% non-condensing. Barometric pressure Operating:700 –1060 hPa. Storage/Transport: 700 –1060 hPa. Dimensions:Ø140 x 35 mm / Ø5.5 x 1.4 inches. Weight:280 g / 10 oz including power supply adapter. Radio Transmitter: Bluetooth compliance: Version 1.1. Operating frequency: 2.402 to 2.480 GHz. Output power: 1 to 100 mW / Bandwith: <1MHz. Antenna type: Internal, omni directional / Antenna gain: -0.8 dBi. Operational range: Up to 100 meters (indoor) depending of surroundings. The frequency band is not harmonized. Use of wireless Bluetooth technology can be restricted in some countries. Contact local authorities for more information. The internal antenna used for this mobile transmitter must provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. RTX Healthcare declares that this device is in compliance with the essential requirements and other relevant provisions of Directive 93/42/ECC. A copy of the declaration of conformity may be found at the RTX website: www.rtx.dk. This device has been tested and found to comply with FCC Part 68. Please read the “US telephone network customer information” in this manual. This device has been tested and found to comply with TBR21. This device, including the power supply adapter, is certified to comply with EN60601-1. This device, including the power supply adapter, is tested according to EN60601-1-2. Data integrity and security: The privacy of data transmission with this device is secured by data encryption and authentication (SSL),and meets authorized standards under the HIPAA. TECHNICAL SPECIFICATIONS RTX3320: The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers. The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. RTX3320 is a “black box” device – it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company. This device does not measure, interpret or make any decisions on the vital data that it conveys. Precautions and warnings This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data. Clinical judgement and experience are required to check and interpret the measurements collected and transmitted. This device is not for use in systems which substitute for medical care. This device is not intended for patients requiring direct medical supervision or emergency intervention. RTX Healthcare · Stroemm…

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

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 1 of 11 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 2 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 3 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 4 of 11

POWER Use only with original power supply F RIWO FW7333M/06 TEST BUT TON CONNECT BUT TON SERVI CE INTERFACE RTX3320 33 20-00A0961D8F70 RTX Healthcare A/S, 9400-Denmark Di str ibuted by RTX Amer ica Inc. 2099 Gateway Pl ace, SanJose, CA USA Type- I D: PSTN Wireless Telehealth Gateway S/N FC C ID: R3ZRTX3320 IC: ????-RTX33 20 ! 01234-012345 US: RTXMM00B3320 2004-0 6 LIN E

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 5 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 6 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 7 of 11

RTX Telecom A/SBOM Product: Variant:Default Version Revision: Created at:17-03-2004 by: tjn Schematic base:s234000_RTX3320.sch REFRTX partnumberDescriptionToleranceCaseManufacturerManufacturer code 1BAT210000006Battery CR2032VartaCR2032 2C102194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 3C202514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 4C302181470Capacitor 47p NP0 50V±5%0603MurataGRM1885C1H470JA01x 5C402194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 6C502194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 7C602194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 8C702194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 9C802114330Capacitor 33nF X7R 630V±10%1210MurataGRM32DR72J333KW01x 10C902194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 11C1002181220Capacitor 22p NP0 50V±5%0603MurataGRM1885C1H220JA01x 12C1100000000Component not mounted 13C1200000000Component not mounted 14C1302378472Capacitor ELLYT 470uF 16V Low ESR±20%8 x 10NichiconUUD1C471MNR1GS 15C1402514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 16C1502514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 17C1602378472Capacitor ELLYT 470uF 16V Low ESR±20%8 x 10NichiconUUD1C471MNR1GS 18C1702194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 19C1802194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 20C1902514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 21C2002514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 22C2102514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 23C2202514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 24C2302514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 25C2402514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 26C2502514100Capacitor 10nF X7R 25V±10%0402MurataGRM155R71E103KA01x 27C2602194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 28C2702194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 29C2802194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 30C2902180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 31C3002180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 32C3102194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 33C3202180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 34C3302194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 35C3402194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 36C3502180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 37C3600000000Component not mounted 38C3702180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 39C3802180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 40C3902194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 41C4002180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 42C4102181100Capacitor 10p NP0 50V±5%0603MurataGRM1885C1H100JZ01x 43C4202194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 44C4302194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 45C4402194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 46C4502181120Capacitor 12p NP0 50V±5%0603MurataGRM1885C1H120JA01x 47C4602181120Capacitor 12p NP0 50V±5%0603MurataGRM1885C1H120JA01x 48C4702181150Capacitor 15p NP0 50V±5%0603MurataGRM1885C1H150JA01x 49C4802181150Capacitor 15p NP0 50V±5%0603MurataGRM1885C1H150JA01x 50C4902194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 51C5002194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 52C5102114330Capacitor 33nF X7R 630V±10%1210MurataGRM32DR72J333KW01x 53C5202182150Capacitor 150p NP0 50V±5%0603MurataGRM1885C1H151JA01x 54C5300000000Component not mounted 55C5400000000Component not mounted Page 1 of 4 RTX Telecom A/SBOM 56C5502181100Capacitor 10p NP0 50V±5%0603MurataGRM1885C1H100JZ01x 57C5602182150Capacitor 150p NP0 50V±5%0603MurataGRM1885C1H151JA01x 58C5702194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 59C5802194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 60C5902194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71H103KA01x 61C6002195100Capacitor 100n X7R 16V±10%0603MurataGRM188R71C104KA01x 62C6102195100Capacitor 100n X7R 16V±10%0603MurataGRM188R71C104KA01x 63C6202195100Capacitor 100n X7R 16V±10%0603MurataGRM188R71C104KA01x 64C6302406221Capacitor 2.2uF 10V Tantal±20%AVishay293D225X0010A2x 65C6402195100Capacitor 100n X7R 16V±10%0603MurataGRM188R71C104KA01x 66C6502406100Capacitor 1uF 16V Tantal±20%A2 United Chemi-Con16MCS105MA2TER 67C6602193100Capacitor 1n X7R 50V±10%0603MurataGRM188R71H102KA01x 68C6702194150Capacitor 15n X7R 50V±10%0603MurataGRM188R71H153KA01x 69C6802195100Capacitor 100n X7R 16V±10%0603MurataGRM188R71C104KA01x 70C6902064471Capacitor 47nF X7R 250V±10%1206MurataGRM31CR72E473KW03x 71C7002181220Capacitor 22p NP0 50V±5%0603MurataGRM1885C1H220JA01x 72C7102181220Capacitor 22p NP0 50V±5%0603MurataGRM1885C1H220JA01x 73C7202561100Capacitor 10pF Y2±5%1808MurataGA342D1XGF100JY02L 74C7302561100Capacitor 10pF Y2±5%1808MurataGA342D1XGF100JY02L 75C7402092220Capacitor 220pF 630V type R±10%1206MurataGRM31AR32J221KY01x 76C7502562470Capacitor 470 pF Y3 250VAC X7R±10%1808MurataGA342QR7GD471KW01L 77C7602562470Capacitor 470 pF Y3 250VAC X7R±10%1808MurataGA342QR7GD471KW01L 78C7702181100Capacitor 10p NP0 50V±5%0603MurataGRM1885C1H100JZ01x 79C7802181100Capacitor 10p NP0 50V±5%0603MurataGRM1885C1H100JZ01x 80C7902182470Capacitor 470p NP0 50V±5%0603MurataGRM1885C1H471JA01x 81C8002180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 82C8202180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 83C8302180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 84C8402180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 85C8502180560Capacitor 5p6 NP0 50V±0.5pF0603MurataGRM1885C1H5R6CZ01x 86C8602036471Capacitor 4.7uF Y5V 10V +80/-20%0805MurataGRM21BF51A475ZA01x 87C8702036471Capacitor 4.7uF Y5V 10V+80/-20%0805MurataGRM21BF51A475ZA01x 88C8802194100Capacitor 10n X7R 50V±10%0603MurataGRM188R71…

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

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PART 15 / SUBPART C FCC ID: R3ZRTX3320 Test report no.: G0M20403-8572-P-15 FCC ELECTRONIC TECHNOLOGY SYSTEMSSTORKOWER STRASSE 38C, D-15526 REICHENWALDE B. BERLIN DR. GENZ GMBHPHONE +49-33631-888 00 FAX +49-33631-888 660 ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 1 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH TABLE OF CONTENTS 1General information 1.1Notes 1.2Testing laboratory 1.3Details of approval holder 1.4Application details 1.5Test item 1.6Test standards 2Technical test 2.1Summary of test results 2.2Test environment 2.3Test equipment utilized 2.4General Test Procedure 3Test Results ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 2 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1General Information 1.1Notes The purpose of conformity testing is to increase the probability of adherence to the essential requirements or conformity specifications, as appropriate. The complexity of the technical specifications, however, means that full and thorough testing is impractical for both technical and economic reasons. Furthermore, there is no guarantee that a test sample which has Passed all the relevant tests conforms to a specification. Neither is there any guarantee that such a test sample will interwork with other genuinely open systems. The existence of the tests nevertheless provides the confidence that the test sample possesses the qualities as maintained and that is performance generally conforms to representative cases of communications equipment. The test results of this test report relate exclusively to the item tested as specified in 1.5. The test report may only be reproduced or published in full. Reproduction or publication of extracts from the report requires the prior written approval of the ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH. Tester: 18.03.2004D. Hoppe DateETS-Lab.NameSignature Technical responsibility for area of testing: 18.03.2004Dr. Genz DateETSNameSignature ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 3 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.2 Testing laboratory 1.2.1Location ELECTRONIC TECHNOLOGY SYSTEM DR. GENZ GMBH (ETS) Storkower Straße 38c D-15526 Reichenwalde b. Berlin Germany Telefon : +49 33631 888 00 Telefax : +49 33631 888 66 1.2.2Details of accreditation status ACCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: TTI-P-G 126/96 ACCREDITED COMPETENT BODY DAR-REGISTRATION NUMBER: BPT-ZE-026/96 FCC FILED TEST LABORATORY REG. NO. 96970 BLUETOOTH QUALIFICATION TEST FACILITY (BQTF) ACCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD INDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 A2LA A CCREDITED Certificate Number 1983-01 1.3Details of approval holder Name: RTX Healthcare A/S Street: Stroemmen 6 Town: 9400 Noerresundby Country: Denmark Telephone: +45 9632 2300 Fax: 0045 9632 2310 Contact: Mr. Niels Ole Andersen E-mail: [email protected] ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 4 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.4Application details Date of receipt of application: 08.03.2004 Date of receipt of test item: 08.03.2004 Date of test: 08.03.2004 – 10.03.2004 1.5Test item Description of test item: Wireless Telehealth Gateway for PSTN Type identification: RTX3320 Hardware version: V2 Software version: Bluetooth V0005, Application V0.8 Serial number: without Photos: See Appendix A Technical data Frequency band: 2.4GHz – 2.4835GHz Frequency ( ch A): 2402 MHz Frequency (ch B): 2441 MHz Frequency (ch C): 2480 MHz TransmitterVnom Power (ch A): Conducted: 12,31 dBm Power (ch B): Conducted: 11,59 dBm Power (ch C): Conducted: 10,78 dBm TransmitterVnomVnom –15%Vnom +15% Power (ch A): Radiated: 13,03 dBmRadiated: 13,03 dBmRadiated: 13,03dBm Power (ch B): Radiated: 10,79 dBmRadiated: 10,89 dBmRadiated: 10,63 dBm Power (ch C): Radiated: 9,56 dBmRadiated: 9,62 dBmRadiated: 9,73 dBm Power supply : 120 V AC/DC Adapter Operating mode: duplex Type of modulation: FHSS Antenna type: Inverted F type antenna Antenna gain: -0,9 dBi (typ.); +3 dBi (max.) ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 5 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Host device: none Classification: Fixed Device Mobile Device (Human Body distance > 20cm) Portable Device (Human Body distance < 20cm) Manufacturer: (if applicable) Name: Street: Town: Country: Additional information:The test sample is designed as Bluetooth device. Its pseudorandom hopping scheme, authentication, receiver parameters, synchronization procedure and other parameters are determined by Bluetooth Core Specification. According to attached declaration of manufacturer this device don’t work in master inquiry mode. So we have only one frequency hopping system and the hopping sequence of the master inquiry mode is not very feed. ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 6 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.6Test standards Technical standard : FCC RULES PART 15 / SUBPART C § 15.247 2Technical test 2.1Summary of test results No deviations from the technical specification(s) were ascertained in the course
of the tests performed. or The deviations as specified in 2.5 were ascertained in the course of the tests  performed. 2.2Test environment Temperature: 23 o C Relative humidity content: 20 ...75 % Air pressure: 86 ...103 kPa Details of power supply: 120V AC-DC adaptor Extreme conditions parameters:: test voltage - extrememin.:102 V max: 138 V ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 7 of 28 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 2.3Test equipment utilized No.Measurement device:Type:Manufacturer: ETS 0001Test receiverESHS 10Rohde&Schwarz ETS 0002Test receiverESVPRohde&Schwarz ETS 0003Test receiverESVS 10Rohde&Schwarz ETS 0004Spectrum- and Network-AnalyzerFSMS 26Rohde&Schwarz ETS 0005Test receiverSMV 11MEB ETS 0006Test receiver systemSME 1…

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

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 8 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 9 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 10 of 11 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, GermanyRegistration number: G0M20403-8572-P-15Page 11 of 11