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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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