Medtronic CareLink USB User Manual

Download

Page 1

User Guide

Page 2

REF MMT-7305

CareLink

is a registered trademark of Medtronic MiniMed.

™ is a trademark of Medtronic MiniMed.

U.S., international, and foreign patent applications pending.

6025278-0U2_a

Page 3

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&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 frequency 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 will 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.

Page 4

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 the 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).

USB extension cables, female ends

unprotectedprotected

(recommended)

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.

Page 5

Specifications

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

Humidity: 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

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

RF emissions CISPR 11 Class B

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/flicker emissions IEC 61000-3-3

Not applicable

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.

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.

Page 6

Guidance and Manufacturers Declaration – Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Level

Electrostatic discharge (ESD) ±6 kV contact ±6 kV contact The CareLink USB should not be affected by

IEC 61000-4-2 ±8 kV air ±8 kV air

Electrical fast transient/burst

±2 kV for power supply lines

Not applicable Not applicable

Electromagnetic Environment -Guidance

electrostatic discharge that might occur under normal conditions of use.

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

±1 kV for input/output lines

±1 kV line(s) to line(s)

±2 kV line(s) to earth

<5% U

(>95% dip in UT) for 0.5 cycle Not applicable Not applicable

40% UT (60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycle

<5% UT (>95% dip in UT) for 5 seconds

Power frequency (50/60 Hz) magnetic field

3 A/m Not applicable Not applicable

IEC 61000-4-8

NOTE: Ut is the a.c. mains voltage prior to application of the test level.

Not applicable

Page 7

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

Portable and mobile RF communications 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

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

Not applicable

d 1.2 P=

d 2.3 P=

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, less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

80 MHz-800 MHz

800 MHz-6 GHz

should be

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.

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 observed 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.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Page 8

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)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 6 GHz

Separation distance according to the frequency of transmitter (m)

d 1.2 P= d 1.2 P= d 2.3 P=

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 meters (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.

Page 9

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 control 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.

Page 10

Icon table

Attention: See instructions for use:

Meaning Symbol

One Per Container/Package: Batch code:

Catalogue number: Storage temperature range:

Recycle:

Conformité Européene (European Conformity). This symbol means that the device fully complies with MDD 93/42/EEC and R&TTE Directive 1999/5/EC.

Date of manufacture:

Signifies compliance with Australian EMC and Radiocommunications requirements:

Fragile product:

RF transmitter, non-ionizing radiation:

(1x)

REF

Authorized Representative in the European Community:

Signifies compliance with Industry Canada EMC and Radiocommunications requirements:

Page 11

International Contact Information

Africa:

Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800

Australia:

Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help)

Bangladesh

Sonargaon Healthcare Pvt Ltd Mobile: (+91)-9903995417 or (+880)-1714217131

België/Belgique:

N.V. Medtronic Belgium S.A. Tel: 0800-90805

Brasil:

Medtronic Comercial Ltda. Tel: +(11) 3707-3707

Canada:

Medtronic of Canada Ltd. Tel: 1-800-284-4416 (toll free/sansfrais)

China:

Medtronic (Shanghai) Ltd. Tel: +86 40 0820 1981 or 80 0820 1981

Croatia

Medtronic Adriatic Tel: +385 1 488 11 20 Fax: +385 1 484 40 60

Danmark:

Medtronic Danmark A/S Tel: +45 32 48 18 00

Deutschland:

Medtronic GmbH Geschäftsbereich Diabetes Telefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633

Eire:

Accu-Science LTD. Tel: +353 45 433000

España:

Medtronic Ibérica S.A. Tel: +34 91 625 05 42 Fax: +34 91 625 03 90 24 horas: +34 901 120 335

Europe:

Medtronic Europe S.A. Europe, Middle East and Africa Headquarters Tel: +41 (0) 21-802-7000

France:

Medtronic France S.A.S. Tel: +33 (0) 1 55 38 17 00

Hellas:

Medtronic Hellas S.A. Tel: +30 210677-9099

Hong Kong:

Celki International Ltd. Tel: +852 2332-3366

India:

India Medtronic Pvt. Ltd Tel: (+91)-80-22112245 / 32972359 Mobile: (+91)-9611633007

Italia:

Medtronic Italia S.p.A. Tel: +39 02 24137 261 Fax: +39 02 24138 210 Servizio assistenza tecnica: N° verde 24h: 800 712 712

Japan:

Medtronic Japan Co. Ltd. Tel: +81-3-6430-2019

Latin America:

Medtronic, Inc. Tel: 1(305) 500-9328 Fax: 1(786) 709-4244

Latvija:

Ravemma Ltd. Tel: +371 7273780

Magyarország:

Medtronic Hungária Kft. Tel: +36 1 889 0697

Malaysia:

Medtronic International Ltd. Tel: +60-3 7953 4800

Middle East and North Africa:

Regional Office Tel: +961-1-370 670

Nederland, Luxembourg:

Medtronic B.V. Tel: +31 (0) 45-566-8291 Toll Free: 0800-3422338

New Zealand:

Medica Pacifica Tel: +0800 106 100 24-hr After-Hours: +0800 633 487

Norge:

Medtronic Norge A/S Tel: +47 67 10 32 00 Fax: +47 67 10 32 10

POCCИЯ:

Medtronic B. V. Tel: (+7-495) 5807377 x1165

Polska:

Medtronic Poland Sp. Z.o.o. Tel: +48 22 465 6934

Portugal:

Medtronic Portugal Lda Tel: +351 21 7245100 Fax: +351 21 7245199

Puerto Rico:

Medtronic Puerto Rico Tel: 787-753-5270

Republic of Korea:

Medtronic Korea, Co., Ltd. Tel: +82.2.3404.3600

Schweiz:

Medtronic (Schweiz) AG Tel: +41 (0)31 868 0160 24-Stunden-Hotline: 0800 633333 Fax Allgemein: +41 (0)318680199

Serbia & Montenegro:

Epsilon Tel: +381 11 311 8883

Singapore:

Medtronic International Ltd. Tel: +65 6436-5097 or +65 6436-5090

Page 12

Slovenija:

Zaloker & Zaloker d.o.o. Tel: +386 1 542 51 11 Fax: +386 1 542 43 32

Slovenská Republika:

Medtronic Slovakia O.Z. Tel: +421 268 206 911

Sri Lanka

Swiss Biogenics Ltd. Mobile: (+91)-9003077499 or (+94)-777256760

Suomi:

Medtronic Finland Oy Tel: +358 20 7281 232

Sverige:

Medtronic AB Tel: +46 8 568 585 10 Fax: +46 8 568 585 11

Taiwan:

Medtronic-Taiwan Ltd. Tel: +886.2.2183.6093 Fax: +886.2.2501.7680 Toll Free: 0800.082.999

Thailand:

Medtronic (Thailand) Ltd. Tel: +66 2 232 7400 ext 1

Turki ye:

Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330

USA:

Medtronic Diabetes Global Headquarters Tel: +1-800-826-2099 24 Hour HelpLine: +1-818-576-5555 To order supplies: +1-800-843-6687

United Kingdom:

Medtronic Ltd. Tel: +44 1923-205167

Yisrael:

Agentek Tel: +972 3649 3111

Österreich:

Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190

Česká Republika:

Medtronic Czechia s.r.o. Tel: (+420-233) 059401