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User Guide - Medtronic Diabetes

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1. 6 kV contact 6 kV contact The CareLink USB should not be affected by electrostatic discharge that might occur under normal conditions of use IEC 61000 4 2 8 kV air 8 kV air Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable Not applicable Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth Not applicable Not applicable Not applicable Not applicable Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 lt 5 UT gt 95 dip in UT for 0 5 cycle Not applicable Not applicable 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycle lt 5 UT gt 95 dip in UT for 5 seconds Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m Not applicable Not applicable NOTE Ut is the a c mains voltage prior to application of the test level 5 Guidance and Manufacturers Declaration Electromagnetic Immunity The CareLink USB is intended for use in the electromagnetic environment specified below The customer or user of the CareLink USB should make sure that it is used in such an environment Immunity Test IEC 60601 Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3V rms 150 kHz to 80 MHz 3V m 80 MHz to 6 GHz Not applicable 3 V m Portable and mobile RF c
2. Fragile product Radio communication Authorized Representative in the European Community Signifies compliance with Industry Canada EMC and Radiocommunications requirements IC 0976 9 International Contact Information USA Medtronic Diabetes Global Headquarters Tel 800 826 2099 24 hour Help Line 818 576 5555 To order supplies 800 843 6687 Europe Medtronic Europe S A Europe Middle East amp Africa Headquarters Tel 41 0 21 802 7000 East Asia Medtronic International Ltd Tel 852 2891 4300 Middle East amp North Africa Regional Office Tel 961 1 370 670 Africa Medtronic Africa Pty Ltd Tel 27 0 11 677 4800 Australia Medtronic Australasia Pty Ltd Tel 1800 668 670 Belgi Belgique N V Medtronic Belgium S A Tel 02 456 0900 Brasil Medtronic Comercial Ltda Tel 11 3707 3707 Canada Medtronic of Canada Ltd Tel 1 800 284 4416 toll free sans frais esk Republika Medtronic Czechia s r o Tel 420 296 579 580 China Medtronic Shanghai Ltd Tel 86 21 5080 0998 24 hour 800 820 1981 Danmark Medtronic Danmark A S Tel 45 32 48 18 00 Deutschland Medtronic GmbH Tel 49 0 211 529 3370 Eire Accu Science LTD Tel 353 45 433000 Espa a Medtronic Ib rica S A Tel 34 91 625 05 42 Fax 34 91 625 03 90 24 hour 34 901 120 335 France Medtronic France S A S Tel 33 0 1 55 38 17 00 Hellas Medtronic Hellas S A Tel 30 210677 9099 India India Medtronic Pvt Ltd Te
3. User Guide USB REF MMT 7305 2007 Medtronic MiniMed All rights reserved Paradigm is a registered trademark of Medtronic MiniMed CareLink is a trademark of Medtronic MiniMed U S international and foreign patent applications pending 6025278 0U1 102207 1 Introduction Indications for use The Medtronic CareLink USB is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes therapy management devices that use Paradigm compatible RF telemetry MWT1 and a personal computer that uses data management application software Contraindications None known Warnings Product may pose a choking hazard for young children Compliance information This device complies with the United States Federal Communications Commission FCC and international standards for electromagnetic compatibility The 868 35 MHz version MMT 7305WW conforms to the essential requirements of the Council Directive 1999 5 EC R amp TTE The following information is provided in accordance with Federal Communications Commission FCC regulations 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 undesirable operation This device does not interfere with any radio fr
4. and Medtronic Thailand Ltd Tel 66 2654 3466 Turkiye Medtronic Medikal Teknoloji Ticaret Ltd Sirketi Tel 90 216 4694330 United Kingdom Medtronic Ltd Tel 44 1923 205167 Yisra el Agentek Tel 972 3649 3111
5. equency signals transmitted from outside sources These FCC standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference Important Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment RF interference from other wireless devices Common consumer electronic devices that transmit in the same frequency band used by the MMT 7305 CareLink USB may prevent the CareLink USB from receiving the data sent by Medtronic diabetes therapy management devices Most cellular phones and 900 MHz cordless phones when transmitting or receiving may cause significant interruption of transmitter receiver communication It is likely that other devices operating in similar frequency ranges will have a similar effect This interference however will not cause any incorrect data to be sent and will not cause any harm to your CareLink USB Communication problems can typically be resolved by ensuring that the distance between transmitter and receiving device is less than 1 9 meters 6 feet and by turning off or moving away from other RF transmitting devices You can also reorient or relocate the CareLink USB and or the transmitting device to try to correct the interference Testing conducted with several different cellular phones suggests that interference wil
6. he USB port on the back of a personal computer You may also plug your CareLink USB into USB ports on the front of your personal computer or into any USB port on a laptop computer It is recommended that the CareLink USB be plugged directly into a USB port on the computer A USB extension cable can be used if you do not have easy access to your computer s USB ports but it is recommended that you use only a USB cable with a protected female end see illustration at right Troubleshooting If you plug your CareLink USB into a USB port on your computer and it does not work remove it and plug it into another USB port on your computer This is a rare but continuing issue with USB ports and many USB devices If your CareLink USB does not work in any USB port on your computer call your local HelpLine for assistance Electrostatic discharge ESD may temporarily prevent the CareLink USB from transmitting If you touch the metal of the CareLink USB or the unprotected end of a USB cable while it is connected to your computer and your CareLink USB stops transmitting remove it and plug it back in being careful not to touch the metal parts USB extension cables female ends unprotected protected recommended 3 Specifications Guidance and manufacturers declaration Operating conditions Temperature 0 C to 40 C Humidity 0 to 95 Atmospheric pressure 70 0kPa to 106 0kPa Storage conditions Temperature 20 C to 55 C Hu
7. l 91 2652 604 900 Italia Medtronic Italia S p A Tel 390 2 24137 261 Servizio assistenza tecnica No verde 24h 800 712 712 Japan Medtronic Japan Co Ltd Tel 81 3 6430 2001 Republic of Korea Medtronic Korea Ltd Tel 82 2 3404 3600 Latvija Ravemma Ltd Tel 371 7273780 Magyarorsz g Medtronic Hung ria Kft Tel 36 1 889 0600 Nederland Luxembourg Medtronic B V Tel 31 0 45 566 8290 New Zealand Medica Pacifica Tel 64 9629 0823 Norge Medtronic Norge A S Tel 47 67 10 32 00 Fax 47 67 10 32 10 sterreich Medtronic sterreich GmbH Tel 43 0 1 240 44 0 24 Stunden Hotline 0820 820 190 Polska Medtronic Poland Sp z o o Tel 48 22 4656 900 Portugal Medtronic Portugal Lda Tel 351 21 7245100 Fax 351 21 7245199 Puerto Rico Medtronic Puerto Rico Tel 787 753 5270 POCC Medtronic B V Tel 7 095 5807377 1161 Schweiz Suisse Svizzera Medtronic Suisse SA Tel 41 0 21 803 8006 24 Stunden Hotline 41 0 21 803 89 99 Serbia amp Montenegro Novolab Serbia amp Montenegro Epsilon Research Ltd Tel 381 63 219 827 Singapore Medtronic International Ltd Tel 65 6776 6255 Slovenija Zaloker amp Zaloker d o o Tel 386 1 54 25 111 Slovensk Republika Medtronic Slovakia o z Tel 421 2 68 20 69 12 Suomi Medtronic Finland OY Tel 358 9 755 25 00 Sverige Medtronic AB Tel 46 8 568 585 00 Fax 46 8 568 585 01 Taiwan Medtronic Mediland Ltd Tel 886 2 2517 0308 Thail
8. l not be a problem if the phone is at least 2 3 meters 7 5 feet from the transmitter or receiving device while the phone is being used greater separation distance may be required for certain devices RF Compatibility Medtronic diabetes therapy management devices transmit in different radio frequency RF bands depending on the region of the world in which they are sold If you purchased your Medtronic diabetes therapy management device and CareLink USB in different regions they may not work together If your CareLink USB does not seem to recognize your device this may be the reason Contact your local HelpLine for assistance MWT1 is the brand name for the Medtronic MiniMed proprietary RF telemetry protocol 2 Installing the CareLink USB on your computer Your CareLink USB must be properly installed before it can transfer data from Medtronic diabetes therapy management devices Please follow these installation instructions Do not plug your CareLink USB into your computer until you have installed the associated drivers and or are prompted by the CareLink software Installing the CareLink USB drivers Refer to the user guide of your Medtronic Diabetes data management application software for instructions on how to load the CareLink USB drivers onto your computer After you have followed the user guide instructions plug your CareLink USB into your computer The illustrations at right show the CareLink USB being plugged into t
9. midity 0 to 95 non condensing Atmospheric pressure 50 0kPa to 106 0kPa Transmitter frequency 868 35 MHz MMT 7305WW 916 50 MHz MMT 7305NA Guidance and Manufacturers Declaration Electromagnetic Emissions The CareLink USB MMT 7305 is intended for use in the electromagnetic environment specified below The customer or the user of the CareLink USB should make sure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The CareLink USB uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The CareLink USB is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable 4 Guidance and Manufacturers Declaration Electromagnetic Immunity The CareLink USB MMT 7305 is intended for use in the electromagnetic environment specified below The customer or the user of the CareLink USB should make sure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD
10. ol of the manufacturer If damage results from negligence or improper use including but not limited to improper storage deliberate submersion in water physical abuse such as dropping or otherwise This warranty shall be personal to the original user Any sale rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate The remedies provided for in this warranty are the exclusive remedies available for any breach hereof Neither Medtronic MiniMed nor its suppliers or distributors shall be liable for any incidental consequential or special damage of any nature or kind caused by or arising out of a defect in the product Any statutory rights granted to consumers under any applicable legislation are reserved All other warranties express or implied except any applicable mandatory statutory warranties are excluded including the warranties of merchantability and fitness for a particular purpose 8 Icon table Meaning Symbol Attention See instructions for use One Per Container Package 1x Batch code Catalogue number REF Storage temperature range Recycle CE mark by notified body as a medical device CE mark as a radio transmitter under the R amp TTE 1999 5 EC directives Applies to 868 MHz MMT 7305WW Date of manufacture Signifies compliance with Australian EMC and Radiocommunications requirements
11. ommunications equipment should be used no closer to any part of the CareLink USB than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Not applicable 80 MHz 800 MHz 800 MHz 6 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol L NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy To access the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CareLink USB is used exceeds the applicable RF compliance level above the CareLink USB should be obser
12. rs m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people d 1 2 P d 1 2 P d 2 3 P 7 Warranty Medtronic MiniMed warrants the Medtronic CareLink USB against defects in materials and workmanship for a period of six 6 months from the date of purchase During the warranty period Medtronic MiniMed will replace at its discretion any defective Medtronic CareLink USB subject to the conditions and exclusions stated herein This warranty applies only to new devices In the event that a Medtronic CareLink USB is replaced the warranty period will not be extended This warranty is valid only if the Medtronic CareLink USB is used in accordance with the manufacturer s instructions This warranty will not apply If damage results from changes or modifications made to the Medtronic CareLink USB by the user or third persons after the date of manufacture If damage results from service or repairs performed by any person or entity other than the manufacturer If damage results from a Force Majeure or other event beyond the contr
13. ved to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the CareLink USB or the transmitting device from which it is receiving signals b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m d 1 2 P d 2 3 P 6 Recommended separation distances between portable and mobile RF communications equipment and the CareLink USB This section provides information on the recommended separation distance between portable and mobile RF communications equipment and the CareLink USB The CareLink USB is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the CareLink USB users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CareLink USB as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to the frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 6 GHz 0 01 Not applicable 0 12 0 23 0 1 Not applicable 0 38 0 74 1 Not applicable 1 2 2 3 10 Not applicable 3 8 7 4 100 Not applicable 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in mete

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