R3ZRTX3370RTX3370 Monitor

PART# 50100002 US/UK Ver 3.0 H O W TO I N S TA L L A N D I N S T R U C T I O N S F O R U S E R T X 3 3 7 0 T E L E H E A LT H M O N I TO R • U S E R M A N U A L The RTX3370 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable healthcare providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3370 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line. The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys. Important information n It is important that the cables be carefully arranged and secured to avoid unintended disconnection, or the possibility of tripping or blocking the path of a wheelchair or other moving objects. n Be careful not to use a power socket that may be switched off unintendedly. n Do not install or service the device, power adapter or cables during an electrical storm. n Do not place the RTX3370 in extreme climatic conditions (excessive heat or humidity, in direct sunlight or where it may be exposed to large amounts of dust). n Do not place beverages near the RTX3370 as spills may easily result in serious damage. n Protect the device and cables from damage. n Keep pets and small children away from the area where the RTX3370 and cables are located. n Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. I N T E N D E D U S E 2 Contraindications, precautions and warnings n 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. n All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. n This device is not for use in systems, that substitute for medical care. n This device is not intended for patients requiring direct medical supervision or emergency intervention. External devices to be used with RTX3370 n A&D Bluetooth Weight Scale “UC-321PBT”. Wireless Bluetooth connection. n A&D Bluetooth Blood Pressure Monitor “UA-767PBT”. Wireless Bluetooth connection. n Roche “Accu-Chek Compact”, “Accu-Chek Compact Plus”, “Accu-Chek Aviva”. Infrared connection. n Lifescan “OneTouch Ultra”. Cable connection. n Abbot/Therasense “Freestyle”. Cable connection. n A&D Weight Scale “UC-321PL”. Cable connection. n THT Weight Scale “SC-1”. Cable connection. n PiKo-1 peak flow meter. Cable connection. F U N C T I O N A L I T Y 3 The RTX3370 Telehealth Monitor is used for reception and communication of measurements taken by on-site external devices such as Blood Pressure Monitors, Personal Weight Scales, Blood Glucose Meters and other compatible devices: The communication will be performed using: n Wireless data connection. n Infrared data connection. n Cable connection. The display on the RTX3370 can be used to show questions that can be answered by pushing the selection buttons below the display. The current function of the right and left selection buttons will be stated in the display. If nothing is stated the button is disabled. A speaker is used to support the information shown in the display verbally. If a menu appears, where different options are listed the up and down buttons to the right of the display can be used to navigate in the list before selecting the appropriate choice. After the RTX3370 has received the measured values and answers, it generates a call and conveys the data to a remote facility via a public telephone line. In some cases, the RTX3370 is programmed to deliver data at a specific time of the day. The delivery of data will automatically be repeated if the attempt to deliver data fails. Cleaning and Maintenance The RTX3370 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 RTX3370. 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 particular installation. If this equipment does cause harmful interference to radio or television 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: n Reorient or relocate the receiving antenna of the other equipment. n Increase the separation between the equipment and receiver. n Connect the equipment into an outlet on a circuit different from the one used for the receiver. n Consult the manufacturer 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 RTX Healthcare could void the user’s authority to operate the equipment. P…

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ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 1 of 13 Appendix A. Pictures ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 2 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 3 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 4 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 5 of 13

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ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 6 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 7 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 8 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 9 of 13 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 10 of 13

ETS PRODUCT SERVICE AG TEST - REPORT FCC RULES PARTS 15.247 IC RADIO STANDARDS RSS-210 Issue 6 FCC ID: R3ZRTX3370 Model Name: RTX3370 Test report no.: G0M20704-1283-P-15 Certificate #1983.01 ETS STORKOWER STRASSE 38C, D-15526 REICHENWALDE B. BERLIN PRODUCT SERVICE AG PHONE +49-33631-888 00 FAX +49-33631-888 660 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 1 of 33 TABLE OF CONTENTS 1 General information 1.1 Notes 1.2 Testing laboratory 1.3 Details of approval holder 1.4 Application details 1.5 Test item 1.6 Test standards 2 Technical test 2.1 Summary of test results 2.2 Test environment 2.3 Test equipment utilized 2.4 General test procedure 2.5 Test results 3 Transmitter parameters 3.1 RF power output conducted 3.2 RF power output radiated (EIRP) 3.3 20 dB bandwidth 3.4 Time of occupancy (dwell time) 3.5 Number of hopping frequencies 3.6 Carrier frequency separation 3.7 Spurious emission conducted 3.8 Spurious emission radiated 3.9 Band-edge compliance 3.10 AC power line conducted emission 4 Receiver parameters 4.1 Radiated emission APPENDIX ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 2 of 33 1 General information 1.1 Notes 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 ETS PRODUCT SERVICE AG. Tester: 11.07.2007 D. Hoppe Date ETS-Lab. Name Signature Technical responsibility for area of testing: 11.07.2007 N. Kaspar Date ETS Name Signature ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 3 of 33 1.2 Testing laboratory 1.2.1 Location ETS PRODUCT SERVICE AG Storkower Straße 38c D-15526 Reichenwalde b. Berlin Germany Telephone : +49 33631 888 00 Telefax : +49 33631 888 660 1.2.2 Details of accreditation status A CCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: DAT-P-201/96 ACCREDITED COMPETENT BODY BNETZA-REGISTRATION NUMBER: BNETZA-ZS-026/96 FCC FILED TEST LABORATORY: REG. NO. 96970 INDUSTRY CANADA FILED TEST LABORATORY R EG. NO.: IC 3470 A2LA ACCREDITED C ERTIFICATE NUMBER: #1983.01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) ACCREDITED BY: BLUETOOTH QUALIFICATION REVIEW BOARD (BQRF) 1.3 Details of approval holder Name : RTX Healthcare A/S Street : Stroemmen 6 Town : 9400 Noerresundby Country : Denmark Telephone : 0045 9632 2300 Contact : Mr. Søren Vester E-Mail : [email protected] ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 4 of 33 1.4 Application details Date of receipt of application : 16.04.2007 Date of receipt of test item : 16.04.2007 Date of test : 20.04.2007 – 06.07.2007 1.5 Test item Description of test item : RTX3370 Monitor Type identification : RTX3370 Serial number : without Photos : See annex A. Technical data Frequency band : 2.4 - 2.4835 GHz Frequency Ch A : 2402 MHz Frequency Ch B : 2441 MHz Frequency Ch C : 2480 MHz Transmitter Vnom Vnom –15 % Vnom +15 % Power (ch A) : Conducted: 12.72 dBm Conducted: 12.84 dBm Conducted: 12.85 dBm Power (ch B) : Conducted: 12.15 dBm Conducted: 12.24 dBm Conducted: 12.26 dBm Power (ch C) : Conducted: 12.75 dBm Conducted: 12.74 dBm Conducted: 12.77 dBm Antenna Type : internal antenna Antenna Gain : 0 dBi(typ); 5 dBm (max) (manufacturer declaration) Power supply : 6.0 V DC 120 V AC/DC Adapter (FW733M/06) Operating mode : duplex Type of modulation : FHSS Host device : none Equipment class : DSS Channels : 79 ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 5 of 33 Classification : Fixed Device Mobile Device (Human Body distance > 20 cm) Portable Device (Human Body distance < 20 cm) Manufacturer: (if applicable) Name : RTX Healthcare A/S Street : Stroemmen 6 Town : 9400 Noerresundby Country : Denmark 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 verified. ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 6 of 33 1.6 Test standards Technical standard: FCC Parts: 15.247 IC Standards: RSS 210 Issue 6 Annex 8.1 2 Technical test 2.1 Summary 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. 2.2 Test environment Temperature : 25 ° C Relative humidity content : 20 ... 75 % Air pressure : 86 ... 103 kPa Details of power supply : 6.0 V DC 120 V AC/DC Adapter (FW733M/06) Extreme conditions parameters: : test voltage - extreme min.: 5.7 V DC (Vnom – 15%) max: 6.3 V DC (Vnom + 15%) ETS Product Service AG Registration number: G0M20704-1283-P-15 Page 7 of 33 2.3 Test equipment utilized No. Test equipment Type Manufacturer ETS 0001 ESD Gun SESD 30000 Schlöder ETS 0002 Test receiver ESVP R & S ETS 0003 Diode Power Sensor NRV-Z2 R & S ETS 0004 Sp…

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