R3ZDLM112DayLink Monitor DLM112

RTX Healthcare · Stroemmen 6 · DK-9400 Noerresundby · Denmark · Phone: +45 9632 2300 · www.rtx.dk RTX America, Inc. · 2099 Gateway Place · Suite 310 · San Jose · California 95110 · Phone: +1 (408) 441-8600 n This device is for use at home. n Power requirements Mains: 120 VAC, 60Hz, 200 mA, Class II, No applied part. Only use the original power supply adapter with the type designation FW7333M/06. n Range of temperatures Operating: +10°C to +40°C / +50 F to +104 F Storage: -10°C to +45°C / +14 F to +113 F Transportation: -20°C to +60°C / -4 F to +140 F n Relative humidity Operating/Storage/Transport: 10% to 95% non-condensing. n Barometric pressure Operating/Storage/Transport: 700-1060 hPa. Dimensions (WxLxH): 156 x 145 x 70mm / 6.2 x 5.7 x 2.8 inches. Weight: 425 g / 15 oz including power supply adapter. n 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 Operational range: Up to 100 meters (indoor) depending of surroundings. n 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. n This device has been tested and found to comply with FCC Part 68. Please read the »US telephone network customer information« in this manual. n This device, including the power supply adapter, is certified to comply with UL60601-1. n This device, including the power supply adapter, is tested according to EN60601-1-2. n 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. n Only dispose the DLM112 at an appropriate recycle facility for electronics. Ask RTX for more information. T E C H N I C A L S P E C I F I C AT I O N S PART# 50100002 US/UK 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 D AY L I N K M O N I TO R • D L M 11 2 • U S E R M A N U A L The Daylink 112 Monitor (“DLM112”) is for use by patients at home. It is intended to be used in combination with a variety of external devices upon prescription of a licensed physician or other authorized healthcare provider. DLM112 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 center, 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 installation must be performed by or under supervision of an authorized 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 sometimes 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. 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 which may be switched off unnoticed. n Do not install or service the device, power adapter or cables during an electrical storm. n Do not place the DLM112 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 DLM112 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 DLM112 and cables are located. The DLM112 Remote Patient 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 Monitors 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 DLM112 can be used to show questions that can be answered by pushing the keys below the display. A speaker will support the information shown on the display verbally. When the DLM112 has received the measured values and the answers, it generates a call and conveys the data to a remote facility via a public telephone line. In some cases, the DLM112 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. Cleaning and Maintenance The DLM112 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 DLM112. 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 …

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ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 1 of 10 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 2 of 10 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 3 of 10

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PARTS 15.247 IC RADIO STANDARDS RSS-210 Annex 8 FCC ID: R3ZDLM112 IC: Model Name: DLM112 Test report no.: G0M20605-0507 - P-15 Certificate 1983-01 ELECTRONIC TECHNOLOGY SYSTEMS STORKOWER STRASSE 38C, D-15526 REICHENWALDE B. BERLIN DR. GENZ GMBH PHONE +49-33631-888 00 FAX +49-33631-888 660 ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 1 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 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 Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 2 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 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 ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH. Tester: 06.06.2006 W. Treffke Date ETS-Lab. Name Signature Technical responsibility for area of testing: 06.06.2006 N. Kaspar Date ETS Name Signature ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 3 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.2 Testing laboratory 1.2.1 Location ELECTRONIC TECHNOLOGY SYSTEM DR. GENZ GMBH (ETS) Storkower Straße 38c D-15526 Reichenwalde b. Berlin Germany Telephone : +49 33631 888 00 Telefax : +49 33631 888 66 1.2.2 Details of accreditation status ACCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: DAT-P-201/96 A CCREDITED COMPETENT BODY DAR-REGISTRATION NUMBER: BPT-ZE-026/96 FCC FILED TEST LABORATORY: REG. NO. 96970 INDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 A2LA ACCREDITED CERTIFICATE NUMBER: 1983-01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED 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 Fax : 0045 9632 2310 Contact : Mr. Søren Vester E-Mail : 0045 9632 2300 ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 4 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.4 Application details Date of receipt of application : 29.05.2006 Date of receipt of test item : 29.05.2006 Date of test : 29.05.2006 – 30.05.2006 1.5 Test item Description of test item : DayLink® Monitor Type identification : DLM112 Serial number : without Photos : See annex A. Tested frequencies Frequency Ch A : 2402 MHz Frequency Ch B : 2441 MHz Frequency Ch C : 2480 MHz Technical data Frequency band : 2.4 - 2.4835 GHz Switching range : 2.402 – 2.480 GHz Transmitter Vnom Power (ch A) : Conducted: 12.59 dBm Power (ch B) : Conducted: 13.15 dBm Power (ch C) : Conducted: 13.89 dBm Antenna Type : Printed inverted F_antenna Antenna Gain : typ. 0 dBi; max. 5 dBi Power supply : 6.0 V DC 120 V AC/DC Adapter Operating mode : duplex Type of modulation : FHSS Emission designator : 1M00F7 D Host device : none Channels : 79 ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 5 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 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 Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 6 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 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 ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 7 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 2.3 Test equipment utilized No. Test equip…

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ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 7 of 10 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 8 of 10 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 9 of 10 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20605-0507-P-15 Page 10 of 10