Medtronic MiniMed 7731 The Guardian Link transmitter is a component of the continuous glucose monitoring system for the MiniMed 600 series insulin pumps. The transmitter collects data from the glucose sensor and then wirelessly sends the data to the insulin pump. User Manual

Medtronic MiniMed, Inc. The Guardian Link transmitter is a component of the continuous glucose monitoring system for the MiniMed 600 series insulin pumps. The transmitter collects data from the glucose sensor and then wirelessly sends the data to the insulin pump. Users Manual

Users Manual

CAUTION: Investigational Device Limited by Federal Law to Investigational Use.
Contacts: Africa: Medtronic Africa (Pty) Ltd.Tel: +27 (0) 11 677 4800Australia: Medtronic Australasia Pty. Ltd.Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help)Azerbaijan: Albatros Health CareTel: +994 12 498 9537Bangladesh Sonargaon Healthcare Pvt Ltd.Mobile: (+91)-9903995417 or (+880)-1714217131Belarus: Badgin LtdTel: +375 (172) 665128België/Belgique: N.V. Medtronic Belgium S.A.Tel: 0800-90805Bosnia and Herzegovina IntermedicalTel: +387 33 202 183 Fax: +387 33 202 183Brasil: Medtronic Comercial Ltda.Tel: +(11) 3707-3707Bulgaria Interagro-90 LtdTel: +359 888 636 033Canada: Medtronic of Canada Ltd.Tel: 1-800-284-4416 (toll free/sans-frais)China: Medtronic (Shanghai) Ltd.24 Hour Help (Cell): +86 400-820-1981 24 Hour Help (Landline): +86 800-820-1981Croatia Oktal PharmaTel: +385 1 659 57 77 Fax: +385 1 659 57 01Croatia Medtronic B.V.Tel: +385 1 488 11 20 Fax: +385 1 484 40 60Danmark: Medtronic Danmark A/STel: +45 32 48 18 00Deutschland: Medtronic GmbH Geschäftsbereich DiabetesTelefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633Eire: Accu-Science LTD.Tel: +353 45 433000España: Medtronic Ibérica S.A.Tel: +34 91 625 05 42 Fax: +34 91 625 03 90 24 horas: +34 901 120 335Europe: Medtronic Europe S.A. Europe, MiddleEast and Africa HeadquartersTel: +41 (0) 21-802-7000France: Medtronic France S.A.S.Tel: +33 (0) 1 55 38 17 00Hellas: Medtronic Hellas S.A.Tel: +30 210677-9099Hong Kong: Medtronic International Ltd.Tel: +852 2919-1300 To order supplies: +852 2919-1322 24-hour helpline: +852 2919-6441India: India Medtronic Pvt. LtdTel: (+91)-80-22112245 / 32972359 Mobile: (+91)-9611633007Indonesia: Medtronic International Ltd.Tel: +65 6436 5090 or +65 6436 5000Israel: AgentekTel: +972 3649 3111Italia: Medtronic Italia S.p.A.Tel: +39 02 24137 261 Fax: +39 02 24138 210 Servizio assistenza tecnica: Nº verde 24h: 800 20 90 20Japan: Medtronic Japan Co. Ltd.Tel: +81-3-6430-2019 24 Hr. Support Line: 0120-56-32-56
Kazakhstan: Medtronic Kazakhstan B.V.Tel: +77273110580Latin America: Medtronic, Inc.Tel: 1(305) 500-9328 Fax: 1(786) 709-4244Latvija: Ravemma Ltd.Tel: +371 7273780Macedonia: KemofarmTel: +389 2 260 36 03 Fax: +389 2 260 36 49Magyarország: Medtronic Hungária Kft.Tel: +36 1 889 0688Malaysia: Medtronic International Ltd.Tel: +603 7946 9000Middle East and North Africa: Regional OfficeTel: +961-1-370 670Montenegro: GlosarijTel: +382 20 642 495 Fax: +382 20 642 540Nederland, Luxembourg: Medtronic B.V.Tel: +31 (0) 45-566-8291 Gratis: 0800-3422338New Zealand: Medica PacificaPhone: 64 9 414 0318 Free Phone: 0800 106 100Norge: Medtronic Norge A/STel: +47 67 10 32 00 Fax: +47 67 10 32 10POCCИЯ: Medtronic B. V.Tel: +7 495 580 73 77 24h: 8-800-200-76-36Philippines: Medtronic International Ltd.Tel: +65 6436 5090 or +65 6436 5000Polska: Medtronic Poland Sp. Z.o.o.Tel: +48 22 465 6934Portugal: Medtronic Portugal LdaTel: +351 21 7245100 Fax: +351 21 7245199Puerto Rico: Medtronic Puerto RicoTel: 787-753-5270Republic of Korea: Medtronic Korea, Co., Ltd.Tel: +82.2.3404.3600Romania: Trustmed SRLTel: +40 (0) 21 220 6477Schweiz: Medtronic (Schweiz) AGTel: +41 (0)31 868 0160 24-Stunden-Hotline: 0800 633333 Fax Allgemein: +41 (0)318680199Serbia EpsilonTel: +381 11 311 5554 Fax: +381 11 311 5554Singapore: Medtronic International Ltd.Tel: +65 6436 5090 or +65 6436 5000Slovenija: Zaloker & Zaloker d.o.o.Tel: +386 1 542 51 11 24-h pomoč: 386 51 316 560Slovenská republika: Medtronic Slovakia o.z.Tel: +421 26820 6986 Fax: +421 268 206 999Sri Lanka Swiss Biogenics Ltd.Mobile: (+91)-9003077499 or (+94)-777256760Suomi: Medtronic Finland OyTel: +358 20 7281 200 Help line: +358 400 100 313Sverige: Medtronic ABTel: +46 8 568 585 20 Fax: +46 8 568 585 11Taiwan: Medtronic-Taiwan Ltd.Tel: +886.2.2183.6068 Toll Free: +886.0800.005.285Thailand: Medtronic (Thailand) Ltd.Tel: +662 232 7400Turkiye: Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi.Tel: +90 216 4694330
USA: Medtronic Diabetes Global HeadquartersTel: +1-800-646-4633 24 Hour HelpLine: +1-800-826-2099 To order supplies: +1-800-843-6687Ukraine: Med EK Service Ltd.Tel: +380445457705United Kingdom: Medtronic Ltd.Tel: +44 1923-205167Österreich: Medtronic Österreich GmbHTel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190Česká republika: Medtronic Czechia s.r.o.Tel: +420 233 059 401 Non-stop help line: +420 233 059 059
The Guardian™ Link transmitter is a component of the continuous glucosemonitoring system for the MiniMed™ 640G insulin pump. The transmitter collects datafrom the Enlite™ glucose sensor. The transmitter then wirelessly sends the data tothe insulin pump.Guardian Link transmitter kit componentsA complete Guardian Link transmitter kit includes the following components:•  Guardian Link transmitter (MMT-7763)•  Watertight Tester (MMT-7726)•  Charger (MMT-7715)•  Enlite Serter (MMT-7510)Indications for useThe transmitter is indicated for single-patient use as a component of select Medtroniccontinuous glucose sensing systems and MiniMed sensor-enabled pump systems.ContraindicationsDo not expose your transmitter to MRI equipment, diathermy devices, or otherdevices that generate strong magnetic fields. If your transmitter is inadvertentlyexposed to a strong magnetic field, discontinue use and contact the 24 HourHelpLine or your local representative for further assistance.WarningsProduct contains small parts and may pose a choking hazard for young children.If the tester comes in contact with blood, the tester must be discarded. Dispose of thetester according to the local regulations for medical waste disposal.Bleeding may occur after inserting the sensor. Make sure that the site is not bleedingbefore connecting the transmitter to the sensor. If bleeding occurs, apply steadypressure with a sterile gauze or clean cloth at the insertion site until bleeding stops.After bleeding stops, connect the transmitter to the sensor.Refer to the Enlite Sensor User Guide for all precautions, warnings, and instructionsrelating to the Enlite sensor.-1- English
Contact the 24 Hour HelpLine if you experience any adverse reactions associated withthe transmitter or sensor.Magnetic fieldsDo not expose your transmitter to MRI equipment, diathermy devices, or other devicesthat generate strong magnetic fields. If your transmitter is inadvertently exposed to astrong magnetic field, discontinue use and contact the 24 Hour HelpLine for furtherassistance.X-rays, MRIs, diathermy devices, and CT scansIf you are going to have an x-ray, diathermy treatment, CT scan, MRI or other type ofexposure to radiation, remove your sensor and transmitter before entering a roomcontaining any of these equipment.Important information about airport security systems, and using your transmitter on anairplane, can be found on the Emergency Card. Be sure to carry the Emergency Cardprovided with your pump when you are traveling.PrecautionsRefer to the Enlite Sensor User Guide for all precautions, warnings, and instructionsrelating to the Enlite sensor.Always use the Watertight Tester when cleaning the transmitter. Do not use any othertest plug with the transmitter.Do not twist the tester or sensor while attached to the transmitter. This will damage thetransmitter.Do not allow water, or any other liquid, to come in contact with the tester when it is notconnected to the transmitter. A wet tester can cause damage to the transmitter.Do not allow the transmitter to come in contact with any liquid when not connected to asensor or to the tester.Do not clean the o-rings on the tester, as this can damage the o-rings.NoticeCaution: Any changes or modifications to the devices not expressly approved byMedtronic Diabetes could interfere with your ability to operate theequipment, cause injury, and void your warranty.Radio Frequency (RF) communicationThis device complies with the United States Federal Communications Commission (FCC)and international standards for electromagnetic compatibility.-2-
This device complies with Part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) This device may not cause harmful interference, and (2)this device must accept any interference received, including interference that maycause undesired operation.These standards are designed to provide reasonable protection against excessiveradio frequency interference, and prevent undesirable operation of the devices fromunwanted electromagnetic interference.This equipment has been tested and found to comply with the limits for a Class Bdigital device, pursuant to Part 15 of the FCC rules. These limits are designed toprovide reasonable protection against harmful interference in a residentialinstallation. This equipment generates, uses, and can radiate radio frequency energyand, if not installed and used in accordance with the instructions, may cause harmfulinterference to radio communications. However, there is no guarantee thatinterference will not occur in a particular installation. If this equipment does causeharmful interference to radio or television reception, which can be determined byturning the equipment off and on, the user is encouraged to try to correct theinterference by one or more of the following measures:•  Reorient or relocate the receiving antenna.•  Increase the separation between the equipment and the receiver.This device can generate, use, and radiate radio frequency energy and, if installedand used in accordance with the instructions, may cause harmful interference toradio communications. If the device does cause interference to radio or televisionreception, you are encouraged to try to correct the interference by one or more of thefollowing measures:•  Decrease the distance between the transmitter and the insulin pump to 6 feet(1.8 meters) or less.•  Increase the separation between the transmitter and the device that is receiving/emitting interference.If other devices that employ radio frequencies are in use, such as cell phones,cordless phones, and wireless networks, they may prevent communication betweenthe transmitter and the insulin pump. This interference does not cause any incorrectdata to be sent and does not cause any harm to your devices. Moving away from, orturning off, these other devices may enable communication. If you continue toexperience RF interference, please contact the 24 Hour HelpLine.-3- English
Caution: Changes or modifications to the internal RF transmitter or antenna notexpressly approved by Medtronic could void the user's authority tooperate this insulin delivery system.This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.AssistanceMedtronic MiniMed provides a 24 Hour HelpLine for assistance. The HelpLine is staffedwith representatives who are trained in the set-up and operation of your CGM system.When calling the HelpLine, please have your pump serial number available. Your pumpserial number and the 24 Hour HelpLine phone number are listed on the back of yourdevice.Department Telephone number24 Hour HelpLine (calls within the United States) 800 646 463324 Hour HelpLine (calls outside the United States) +1 818 576 5555Web site www.medtronicdiabetes.comChargerThe transmitter contains a non-replaceable, rechargeable battery that you can rechargeas needed with the charger. The charger has a green light that shows the charging statusand a red light that communicates any problems during charging. If you see a red light,see the Troubleshooting section. The charger needs one AAA alkaline battery, size E92,type LR03 to operate.Note: A new AAA or LR-03 battery contains enough power to recharge the transmitter atleast 40 times. If the battery is installed incorrectly or is low, the charger will notwork. Repeat the battery installation steps using a new battery.-4-
Installing a battery in the charger To install a battery in the charger:1 Push the battery cover in and slide it off (as shown in the following illustration).2 Insert a new Alkaline AAA or LR-03 battery. Make sure the + and - symbols onthe battery align with these same symbols shown on the charger.3 Slide the cover back on the charger until it clicks into place.Charging the transmitterCaution: Charge the transmitter after each sensor use. A fully chargedtransmitter works at least six days without recharging. A depletedtransmitter can take up to one hour to recharge. To charge the transmitter:1 Connect the transmitter to the charger by lining it up, flatside down, with the charger. Push the two componentstogether fully.2 Within 10 seconds after the transmitter is connected, agreen light on the charger will flash for one to two secondsas the charger powers on. For the rest of the charging time,the charger’s green light will continue to flash in a pattern offour flashes with a pause between the four flashes.3 When charging is complete, the green light on the chargerwill stay on, without flashing, for 15 to 20 seconds and thenturn off.4 After the green charger light turns off, disconnect thetransmitter from the charger. The green light on thetransmitter will flash for about five seconds and then turnoff.-5- English
Inserting the sensorAlways refer to the serter user guide for instructions on how to insert the sensor.Connecting the transmitter to the sensorBefore proceeding, have available your pump user guide. To connect the transmitter to the sensor:1 After the sensor is inserted, consult your serter user guide for details on applying therequired overtape.2 Hold the rounded end of the inserted sensor to prevent it from moving duringconnection.3 Hold the transmitter as shown. Line up the two notches on thetransmitter with the side arms of the sensor. The flat side of thetransmitter should face the skin.4 Slide the transmitter onto the sensor until the sensor’s flexiblearms snap into the notches on the transmitter. If the transmitteris properly connected, and if the sensor has had enough time tobecome hydrated, the green light on the transmitter will flashwithin 10 seconds.5 If the transmitter light does not flash, disconnect the transmitter from the sensor, waitfor several seconds and then reconnect. If the transmitter light still does not flash,charge the transmitter.6 When the transmitter light flashes green when connected to the sensor, use yourpump to start the sensor. For more instructions, see your pump user guide.7 After the transmitter successfully sends sensor data to the pump, attach the sensor'sadhesive tab to the transmitter.8 Follow the instructions that appear on the pump screen or follow the instructions inyour pump user guide.-6-
Disconnecting the transmitter from the sensorBefore proceeding, have available your pump user guide. To disconnect the transmitter from the sensor:1 Carefully remove any occlusive dressing from thetransmitter and sensor.2 For the Enlite sensor, remove the adhesive tab from the topof the transmitter.3 Hold the transmitter as shown, and pinch the flexible sidearms of the sensor between your thumb and forefinger.4 Gently pull the transmitter away from the sensor.5 Follow the instructions that appear on the pump or followthe instructions in your pump user guide.Removing the sensorAlways refer to the sensor user guide for instructions on how to remove the sensor.Bathing and swimmingAfter the transmitter and sensor are connected, they form a waterproof seal to adepth of 8 feet (2.4 meters) for up to 30 minutes. You can shower and swim withoutremoving them. No occlusive dressing is needed.Watertight TesterThe tester is used to test the transmitter to make sure it is working. It is also used asa required component for cleaning the transmitter. Properly connecting the tester tothe transmitter will ensure that fluids do not come in contact with the transmitter’sconnector pins. Fluids can cause connector pins to corrode and affect thetransmitter’s performance.The tester can be used for one year. If you continue to use the tester for more thanone year, the transmitter's connector pins could be damaged, because the testercannot continue to provide a waterproof seal. For instructions on how to check theconnector pins, see Inspecting the transmitter connector pins, on page 8.-7- English
Caution: Only use the Watertight Tester with the transmitter. Do not use anyother test plug.i✓Inspecting the transmitter connector pinsThis image is an example of how the connector pins should look.connector openingconnector pinshousingLook inside the transmitter’s connector opening to make sure that the connector pins arenot damaged or corroded. If the connector pins are damaged or corroded, the transmittercannot communicate with the charger or pump. Contact the 24 Hour HelpLine or yourlocal representative. It may be time to replace your transmitter.Also look for moisture inside the connector opening. If you see any moisture, allow thetransmitter to dry for at least one hour. Moisture inside the connector opening couldcause the transmitter to not work properly, and could cause corrosion and damage overtime.-8-
Connecting the tester for testing or cleaningBefore proceeding, have available your pump user guide. To connect the tester:1 Hold the transmitter and the tester as shown. Line up theflat side of the tester with the flat side of the transmitter.2 Push the tester into the transmitter until the flexible sidearms of the tester click into the notches on both sides of thetransmitter.3 Within five seconds, when properly connected, the greenlight on the transmitter flashes for about 10 seconds.4 To test the transmitter, check the sensor icon on the pumpto ensure that the transmitter is sending a signal (see your pump user guide).5 To clean the transmitter, see Cleaning the transmitter, on page 9.6 After testing or cleaning, disconnect the tester from the transmitter.Disconnecting the tester To disconnect the tester:1 Hold the transmitter body as shown and pinch the sidearms of the tester.2 With the tester arms pinched, gently pull the transmitteraway from the tester.Note: To save transmitter battery life, do NOT leave thetester connected after cleaning or testing.Cleaning the transmitterThe transmitter is a single-patient use device and not intended for multi-patient use.Always clean the transmitter after each use.Caution: Do not discard the transmitter in a medical waste container orotherwise subject it to incineration. The transmitter contains abattery that may explode upon incineration.Note: The tester is a required component for cleaning the transmitter. To clean the transmitter:1 Attach the tester to the transmitter.-9- English
2 Rinse the transmitter under room temperature tap water for at least one minute, anduntil visibly clean. Make sure all hard-to-reach areas are rinsed completely.3 Prepare a mild liquid soap solution using one (1) teaspoon of mild liquid soap per one(1) gallon of room temperature tap water.4 With tester still attached, submerge the transmitter in the mild liquid soap solutionand soak for one minute.5 Holding the tester, brush the entire surface of the transmitter using a soft-bristledtoddler toothbrush. Make sure to brush all hard-to-reach areas until visibly clean.6 Rinse the transmitter under running room temperature tap water for at least oneminute, and until all visible liquid soap is gone.7 Dry the transmitter and tester with a clean, dry, non-shedding cloth.8 Disconnect the tester from the transmitter.9 Place the transmitter and tester on a clean, dry, non-shedding cloth and air dry themcompletely.Cleaning the chargerThis procedure is for general cleaning as required, based on physical appearance.Caution: The charger is NOT waterproof. Do NOT immerse in water or any othercleaning agent.Caution: Dispose the charger according to the local regulations for batterydisposal (non-incineration). To clean the charger:1 Wash your hands thoroughly.2 Use a damp cloth with mild cleaning solution, such as a dishwashing detergent, toclean any dirt or foreign material from the outside of the charger. Never use organicsolvents, such as paint thinner or acetone, to clean the charger.3 Place the charger on a clean, dry cloth and air dry for 2–3 minutes.TroubleshootingThe following table contains troubleshooting information for the transmitter, charger, andtester. For more information about troubleshooting, see your pump user guide.-10-
Problem Likely Cause(s) ResolutionYou connected thetransmitter to thecharger and no lightscame on.The transmitter connec-tor pins are damaged orcorroded.Your charger battery hasno power.1 Check the transmitter connector pins fordamage or moisture. For more informa-tion about your connector pins, see In-specting the transmitter connector pins,on page 8. If the pins are damaged or cor-roded, contact the 24 Hour HelpLine oryour local representative. It may be timeto replace your transmitter.2 If there is no damage to the connectorpins, replace the battery in the charger.For instructions on replacing your chargerbattery, see Installing a battery in thecharger, on page 5.During charging, theflashing green light onthe charger turns offand you see a flashingred light on thecharger.Your charger battery islow on power.Replace the battery in the charger. For instruc-tions on replacing your charger battery, see In-stalling a battery in the charger, on page 5.During charging, theflashing green light onthe charger turns offand you see a series ofquick flashing red lightson the charger.Your transmitter is lowon power.1 Charge the transmitter continuously forone hour. If flashing does not stop, pro-ceed to step 2.2 Charge the transmitter continuously foreight hours. If flashing does not stop, callthe 24 Hour HelpLine or your local repre-sentative. It may be time to replace yourtransmitter.During charging, a mixof quick and long flash-ing red lights appearon the charger.Your charger and yourtransmitter are low onpower.1 Replace the battery in the charger. For in-structions on replacing your charger bat-tery, see Installing a battery in thecharger, on page 5.2 Charge the transmitter continuously forone hour. If flashing does not stop, pro-ceed to step 3.3 Charge the transmitter continuously foreight hours. If flashing does not stop, callthe 24 Hour HelpLine or your local repre-sentative. It may be time to replace yourtransmitter.-11- English
Problem Likely Cause(s) ResolutionThe green light on thetransmitter does notflash when you con-nect it to the sensor.Your transmitter is notfully connected.Your transmitter is lowon power.Your sensor is not prop-erly inserted into yourbody.1 Disconnect the transmitter from thesensor.2 Wait for five seconds and reconnect them.If the green light still does not flash, pro-ceed to step 3.3 Fully charge the transmitter. If the greenlight still does not flash, proceed to step 4.4 The sensor may not be properly insertedinto your body. Insert a new sensor.The green light on thetransmitter does notflash when you con-nect it to the tester.Your transmitter is lowon power.Your transmitter is notfully connected.1 Check the connection between the trans-mitter and the tester. If the green light stilldoes not flash, proceed to step 2.2 Fully charge the transmitter.3 Test the transmitter with the tester again.If you still do not see the green light flash,call the 24 Hour HelpLine or your localrepresentative. It may be time to replaceyour transmitter.Your transmitter bat-tery does not last forsix days.Your transmitter is notfully charged when youconnect it to the sensor.The transmitter andpump frequently losewireless connection.1 Fully charge the transmitter before con-necting it to the sensor. If the transmitterbattery still does not last for six days, pro-ceed to step 2.2 Move away from any device that cancause RF interference. For more informa-tion on RF interference, see Radio Fre-quency (RF) communication, on page 2.3 Make sure your pump and your transmitterare located on the same side of your bodyto minimize any RF interference. If yourfully charged transmitter battery continuesto lose power before a full six days, callthe 24 Hour HelpLine or your local repre-sentative. It may be time to replace yourtransmitter.-12-
Problem Likely Cause(s) ResolutionYour transmitter haslost connection withyour pump.Your pump is out ofrange.There is RF interferencefrom other devices.1 Move away from any device that cancause RF interference. For more informa-tion on RF interference, see Radio Fre-quency (RF) communication, on page 2. Ifyour transmitter is still not communicatingwith your pump, proceed to step 2.2 Make sure your pump and your transmitterare located on the same side of your bodyto minimize any RF interference. If yourtransmitter is still not communicating withyour pump, call the 24 Hour HelpLine oryour local representative for assistance.Storing the devicesStore the transmitter, charger, and tester in a clean, dry location at roomtemperature. If the transmitter is not in use, you must charge the transmitter at leastonce every 60 days. Although not required, you may store the transmitter on thecharger. If you are storing the transmitter on the charger, you must disconnect andreconnect the charger and the transmitter at least once every 60 days.SpecificationsBiocompatibility Transmitter: Complies with ISO 10993-1 for body contactApplied parts TransmitterSensorOperating conditions Transmitter temperature: -5°C to 45°C (23°F to 113°F)Caution: When operating the transmitter on a tester in air temperaturesgreater than 41°C (106°F), the temperature of the transmitter may ex-ceed 43°C (109°F)Transmitter relative humidity: 5% to 95% with no condensationCharger temperature: 10°C to 40°C (50°F to 104°F)Charger relative humidity: 30% to 75% with no condensationStorage conditions Transmitter temperature: -25°C to 55°C (-13°F to 131°F)Transmitter relative humidity: 10% to 100% with condensationCharger temperature: -10°C to 50°C (14°F to 122°F)Charger relative humidity: 10% to 95% with no condensation-13- English
Battery life Transmitter: Six days of continuous glucose monitoring immediatelyfollowing a full chargeCharger: Completes 40 typical charging operations using a new AAAalkaline batteryTransmitter frequency2.4 GHz, 2M65G1D modulation, less than 1mW ERPTransmitter expectedlifeThe transmitter expected life is 1 year depending on patient usage.Guardian Link wireless communicationQuality of serviceThe Guardian Link transmitter and the MiniMed 640G insulin pump are associated aspart of an 802.15.4 network for which the pump functions as the coordinator and thetransmitter as an end node. In an adverse RF environment the pump will assess channelchanging needs based on "noise" levels detected during an energy scan. The pump willperform the energy scan if after 10 minutes no CGM transmitter signal has beenreceived. If the channel change occurs the pump will send beacons on the new channel.The Guardian Link transmitter will initiate a channel search when beacon detection failson the associated channel. The search will be conducted across all five channels. Whenthe beacon is located the transmitter will rejoin on the identified channel. Upon re-association any missed packets (up to 10 hours) will be transmitted from the transmitterto the pump.In normal operation the transmitter will transmit a packet every 5 minutes and retransmitthe packet if the data is corrupted or missed.Radio frequency (RF) communications specifications•  Pump to transmitter frequency: 2.4 GHz; proprietary Medtronic protocol; range up to6 feet (1.8 meters).•  Utilizes the IEEE 802.15.4 protocol with the proprietary data format.Data securityThe MiniMed 640G insulin pump is designed to only accept radio frequency (RF)communications from recognized and linked devices (you must program your pump toaccept information from a specific device).The MiniMed 640G insulin pump and system components (meters and transmitters)ensure data security via proprietary means and ensures data integrity using errorchecking processes, such as cyclic redundancy checks.-14-
Guidance and manufacturer's declarationGuidance and Manufacturer's Declaration - Electromagnetic EmissionsThe Guardian Link transmitter is intended for use in the electromagnetic environmentspecified below. The customer or the user of the Guardian Link should make sure thatit is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissions  CISPR 11Group 1 The Guardian Link must emit electromagnetic energy in orderto perform its intended function. Nearby electronic equipmentmay be affected.RF emissions  CISPR 11Class B The Guardian Link is suitable for use in all establishments, in-cluding domestic and those directly connected to the publiclow-voltage power supply network that supplies buildings usedfor domestic purposes.Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian Link is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the Guardian Link should assure that it is used insuch an environment.Immunity Test IEC 60601 Test Level ComplianceLevelElectromagnetic Envi-ronment - GuidanceElectrostatic dis-charge (ESD)IEC 61000-4-2±2 kV, ±4 kV, ±8 kV Air±2 kV, ±4 kV, ±6 kV Indi-rect±8 kV Air±6 kV Indirect±22 kV Air,<5% RHFor use in a typical domes-tic, commercial, or hospitalenvironment.Electrical fast transi-ent/burst±2 kV for power supplylinesNot applicable Requirement does not applyto this battery powereddevice.IEC 61000-4-4 ±1 kV for input/output linesSurgeIEC 61000-4-5±1 kV line(s) to line(s)±2 kV line(s) to earthNot applicable Requirement does not applyto this battery powereddevice.Voltage dips, short in-terruptions and volt-age variations onpower supply linesIEC 61000-4-11<5% UT (>95% dip in UT)for 0.5 cycleNot applicable Requirement does not applyto this battery powereddevice.-15- English
Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian Link is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the Guardian Link should assure that it is used insuch an environment.Immunity Test IEC 60601 Test Level ComplianceLevelElectromagnetic Envi-ronment - GuidancePower frequency  (50/60 Hz) magneticfieldIEC 61000-4-83 A/m 400 A/m4000 A/mPower frequency magneticfields should be at levelscharacteristic of a typical lo-cation in a typical domestic,commercial, or hospitalenvironment.Note: UT is the a.c. mains voltage prior to application of the test level.Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian Link is intended for use in the electromagnetic environment specifiedbelow. The customer or user of the Guardian Link should assure that it is used in suchan electromagnetic environment.Immunity Test IEC 60601 Level Compliance Lev-elElectromagnetic Environ-ment GuidancePortable and mobile RF commu-nications equipment should beused no closer to any part of theGuardian Link, including cables,than the recommended separa-tion distance calculated from theequation applicable to the powerof the transmitter.Refer to the recommended sep-aration distance table for moreinformation.Conducted RF IEC 61000-4-63 V/m 150 kHz to80 MHzNot applicable Not applicable-16-
Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Guardian Link is intended for use in the electromagnetic environment specifiedbelow. The customer or user of the Guardian Link should assure that it is used in suchan electromagnetic environment.Immunity Test IEC 60601 Level Compliance Lev-elElectromagnetic Environ-ment GuidanceRadiated RF IEC 61000-4-33 V/m  80 MHz to6 GHz10 V/m 80 MHz to6 GHzd = 0.35 P 80 MHz to 800 MHzd = 0.70 P 800 MHz to 6 GHzWhere P is the maximum outputpower rating of the transmitter inwatts (W) according to the trans-mitter manufacturer and d is therecommended separation dis-tance in meters (m).Field strengths from fixed RFtransmitters, as determined byan electromagnetic site surveya,should be less than the compli-ance level in each frequencyrangeb.Interference may occur in the vi-cinity of equipment marked withthe following symbol: Note: At 80 MHz and 800 MHz, the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption, and reflection from structures, objects and people.aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephonesand land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be pre-dicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans-mitters, an electromagnetic site survey should be considered. If the measured field strength in thelocation in which the Guardian Link is used exceeds the applicable RF compliance level above, theGuardian Link should be observed to verify normal operation. If abnormal performance is observed, ad-ditional measures may be necessary, such as re-orienting or relocating the Guardian Link.bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.-17- English
Recommended separation distances between the Guardian Link and commonhousehold radio transmittersHousehold RF Transmitter Frequency Recommended Sepa-ration Distance (me-ter)Recommended Sepa-ration Distance (inch)TelephonesCordless Household 2.4 GHz 0.3 12Cordless Household 5.8 GHz 0.3 12TDMA-50 Hz (cell phone) 1.9 GHz 0.3 12TDMA-50 Hz (cell phone) 800 MHz 0.3 12PCS (cell phone) 1.9 MHz 0.3 12DCS (cell phone) 1.8 MHz 0.3 12GSM (cell phone) 900 MHz 0.3 12GSM (cell phone) 850 MHz 0.3 12CDMA (cell phone) 800 MHz 0.3 12Analog (cell phone) 824 MHz 0.3 12CDMA (cell phone) 1.9 MHz 0.3 12WiFi Networks802.11b; 11Mbps maximum 2.4 GHz 1 39.5802.11g; 54 Mbps maximum 2.4 GHz 1 39.5802.11n; 11Mbps maximum 2.4 GHz 1 39.5Bluetooth 500 kb/s 2.4 GHz 0.1 3.93ZigBee 250 kb/s 2.4 GHz 0.1 3.93-18-
Recommended separation distances between portable and mobile RFcommunications equipment and the Guardian LinkThe Guardian Link is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or the Guardian Link users canhelp prevent electromagnetic interference by maintaining a minimum distance be-tween portable and mobile RF communications equipment and the Guardian Link asrecommended below, according to the maximum output power of the communicationsequipment.Rated maximumoutput power oftransmitter (W)Separation distance according to the frequency of transmitter (m)150 kHz to 80MHzNot applicable80MHz to 800MHzd = 0.35 P800MHz to 6.0GHzd = 0.70 P0.01 Not applicable 0.035 0.070.1 Not applicable 0.11 0.111 Not applicable 0.35 0.710 Not applicable 1.1 2.2100 Not applicable 3.5 7For transmitters rated at a maximum output power not listed above, the recommended separation dis-tance d in meters (m) can be estimated using the equation applicable to the frequency of the transmit-ter, where p is the maximum output power rating of the transmitter in watts (W) according to thetransmitter manufacturer.Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.Icon TableSerial numberCatalogue numberOne per container/packageDate of manufacture (year - month)ManufacturerFollow instructions for useStorage temperature range-19- English
Radio communicationConfigurationType BF equipment (protection from electrical shock)IP48Transmitter: Protected against the effects of continuous immersion in water(8 feet (2.4 meters) immersion for 30 minutes).Attention: Read all warnings and precautions in instructions for use.Storage humidity range ©2013 Medtronic MiniMed, Inc. All rights reserved.MiniMed™, Enlite™, and Guardian™ are trademarks of Medtronic MiniMed, Inc.-20-
6025955-011_1MMT-7763MMT-7726MMT-7715MMT-7510

Navigation menu