Polytel GMA Glucose Meter Accessory for Bayer
Contents
1. Batteries F S N 0015B4010204 ANOS V3 19 Figure 8 Label on the bottom of the GMA pelymap wireless GMA BYR Assembled in USA 8 25207 B June 2009 24 Polytel Glucose Meter Accessory GMA Device was tested to comply with the U S and Canadian safety directives Device was tested to comply with the CE MDD directive You should read accompanying documents before use Device complies with both the IEC UL CAN CSA safety and the radio 60601 1 60601 1 2 requirements of these respective standards FCC RA7F2M03GL FCC listing number for the device IC 8229A F2M03GL Industry Canada listing number for the device 5 Operator Maintenance 5 1 Periodic Maintenance Check your GMA now and then to make sure it is working properly and nothing is damaged Make sure the cord that connects from your GMA to the glucose meter is not frayed or damaged 8 25207 B June 2009 25 Polytel Glucose Meter Accessory GMA If your GMA needs repair or is not working right contact Polymap Wireless for service right away 5 2 Cleaning your GMA Although you should not need to clean your GMA very often here is how to do it 1 Unplug the GMA from the glucose meter and remove it from the mesh pocket 2 Take a soft cloth and dampen it with water or a weak solution of household dishwashing liquid mixed with water Wring out the cloth Warning Do not use any sprays or put your GMA in any liquid Sprays and liqu2. batteries see p 9 the receiving station on Disconnected Plug cable firmly cable into glucose meter 3 8 When You re Traveling see p 12 If you are not at home or near your regular Cantsend Receiving Move receiving receiving station the GMA can send the readings even after station may station closer to to a different access point several tries not be GMA or see light is on working manual for Please speak with your monitoring service to set ad properly receiving station this up does Weak missing Replace batteries not show on batteries 3 8 1 Traveling in France Spain or mete Disconnected Plug cable firmly Japan i cable se glucose meter see p 12 The device uses several radio channels Some of Damaged or Send N tO these are not allowed in France Spain or Japan If frayed cable Polymap Wireless you live in or plan to travel to these countries for repair please contact Polymap Wireless 8 25207 B June 2009 19 8 25207 B June 2009 20 Polytel Glucose Meter Accessory GMA 4 Safety Information We are committed to your safety Please read these warnings and cautions 4 1 Patient Safety CAUTION Do not share your glucose meter or GMA with anyone else Letting someone else use your GMA will cause his or her readings to be mistaken for yours i NOTE Polymap Wireless is not responsible for the reading diagnosis or electrical safety of the Contour glucose meter its
3. Polytel Glucose Meter Accessory GMA pelymap wireless Polytel GMA Glucose Meter Accessory for Bayer Ascensia Contour Model PWR 08 07 USER MANUAL Version B Polymap Wireless 310 S Williams Blvd Ste 350 Tucson Arizona 85711 520 747 1811 Mon Fri 9AM 5PM MST www polymapwireless com 8 25207 B June 2009 1 Polytel Glucose Meter Accessory GMA Table of Contents 1 INTRODUCTION eke Rek eN ER RENE Re Re RE RENE RE RE RE Re Re RE EE 4 Ds OVERVIEW de SO Eai 4 1 2 WHO IS THIS FOR ere ede n ie PG Ge EN se ie Ee Ee 5 2 PARTS OF THE GMA ee ees eek eke Res eke Re Re Re Re ee ke Re 6 2 1 RED LIGHT ee ee ee 6 2 2 BATTERY COMPARTMENT ee ee ee 8 2 3 SIZE OF YOUR GMA ES ee 8 3 OPERATING INSTRUCTIONS 0 ccccceeescessceeneess 8 3 1 CHANGING THE BATTERIES ccccceccccccccecccccececececececs 8 3 2 PREPARING THE CARRYING CASE ccccccececececececees 11 3 3 CONNECTING THE DEVICES ccccccecececececececececess 13 3 4 PLACEMENT OF THE GMA AND RECEIVING STATION 14 3 5 HOW TO USE YOUR GMA ccccccccececececececececececs 15 3 6 IF THE TRANSMISSION DIDN T SEND 2cececeeees 18 3 7 DISCONNECTED GLUCOSE METER ee ee ee eed 19 3 8 WHEN YOU RE TRAVELING cccccecececececececececececens 19 3 8 1 Traveling in France Spain or Japan 19 3 9 TROUBLESHOOTING ccecececececcccccceeueceueceneneneneness 20 4 SAFETY INFORMATION esse kes es eek eke Nee ee Re
4. Re 21 4 1 PATIENT SAFE TV sede to Se De se oe de ee 21 42 ELECTRICAL SAFETY osse Ee os oe ie ee ee ORE 22 4 3 COMPLIANCE INFORMATION ee 22 4 3 1 Compliance Requirements sesse esse 23 4 3 2 Compliance Statement sesse ee 23 4 4 ABOUT THE LABEL AT THE BOTTOM OF THE GMA 24 5 OPERATOR MAINTENANCE ee ee eke seke eek ee 25 5 1 PERIODIC MAINTENANCE ee ee ee ee ee eed 25 5 2 CLEANING YOUR GMA ee ee ee ee ee eed 26 8 25207 B ea J ne 2009 1 2 Polytel Glucose Meter Accessory GMA 6 TECHNICAL SPECIFICATIONS esse sesse sees ees ae 26 6 VBATIERIES oes ees dose esse ee ies Se Ee ewe ed 26 6 2 TEMPERATURES sense ee iese ed ee Go er es Ge 27 6 3 COMPATIBILITY WITH OTHER ELECTRICAL MEDICAL E OUIRE NT RR EE EA OR EE EF 27 6 4 SYSTEM AVAILABILITY asse deed seedse erge ee ese Ede 28 T TRADEMARK S inasre eed bee ede oi en geseg oe 28 8 INDEX de es Se EE Gee N de ee eN ee Ee ie 29 8 25207 B June 2009 3 Polytel Glucose Meter Accessory GMA 1 Introduction 1 1 Overview Welcome to the world of wireless medical monitoring In this pamphlet you will learn how to use and maintain your Polytel GMA Glucose Meter Accessory The GMA is an easy to use accessory that lets you send the glucose readings you take with your Contour glucose meter wirelessly to a receiving station This GMA is designed for the Bayer Ascensia Contour glucose meter No more worrying about writing down the test results and
5. carrying them in to your doctor every visit it is all done automatically in your own home There are three parts to sending your readings wirelessly You measure your glucose on the Contour glucose meter The GMA receives the reading from the meter and sends it wirelessly to the receiving station The receiving station receives stores and sends your readings to your service provider usually your doctor s office or a 8 25207 B June 2009 4 Polytel Glucose Meter Accessory GMA monitoring service The station is a separate device that is either a self contained box called an access point or your personal computer cell phone or handheld computer provided by your monitoring service Your monitoring service can explain how to use the receiving station To use the GMA all you have to do is take the reading using your Contour meter as usual Everything else is done automatically for you To make sure all data is sent to your provider if the GMA is unable to find a receiving station it will save the reading along with the date and time you took it The old reading will be sent along with the next reading 1 2 Who is this for The GMA is intended for diabetic patients who want to monitor their glucose levels remotely It can be used by patients in their homes and in their daily lives 8 25207 B June 2009 5 Polytel Glucose Meter Accessory GMA 2 Parts of the GMA Your GMA is easy to maintain set
6. elf The Polytel GMA is a data transmission system only N WARNING Changes made to the product unless expressly approved by Polymap Wireless LLC could void the users license for and the warranty of the device N CAUTION Only use Lithium CR2 size N batteries Using any other type of battery may cause an explosion 8 25207 B June 2009 21 Polytel Glucose Meter Accessory GMA 4 2 Electrical Safety Only authorized maintenance staff should disassemble the GMA This does not include changing the batteries The GMA is classified as CLASS II equipment as per IEC60601 1 and Class Il Medical Devices per 21CFR The Contour meters are approved for use by their manufacturer Polymap Wireless is not responsible for their diagnostic accuracy or their electrical safety fN WARNING Never operate this device in an area where there is a risk of explosion Using electrical equipment in the presence of flammable anesthetics or oxygen may cause an explosion Polymap Wireless personnel must do all servicing of your GMA 4 3 Compliance Information This section is about the telemetry system regulatory compliance requirements and the manufacturer s responsibilities 8 25207 B June 2009 22 Polytel Glucose Meter Accessory GMA 4 3 1 Compliance Requirements Polymap Wireless is responsible for the effects of safety reliability and performance of the GMA as long as You use the equipment according to the
7. ids may penetrate and damage the unit 3 Gently wipe the outside of the unit with the damp cloth 4 Reconnect the GMA to the glucose meter see page 11 and close the mesh pocket see page 13 6 Technical Specifications 6 1 Batteries The GMA uses two CR2 Lithium cells 3V each Max Power consumption 1W A few things to remember Only use CR2 Lithium batteries Replace both batteries at the same time preferably from the same manufacturer 8 25207 B June 2009 26 Polytel Glucose Meter Accessory GMA 6 2 Temperatures Use your GMA in temperatures ranging from 10 to 40 Celsius 50 to 104 Fahrenheit Store your GMA in temperatures ranging from 40 to 70 Celsius 40 to 158 Fahrenheit If you move your GMA from a cold location to a warm location please allow it to come up to room temperature before using it 6 3 Compatibility with other electrical medical equipment Like other electrical medical equipment the GMA unit requires special precautions to make sure that it works with other electrical medical devices This is called electromagnetic compatibility EMC As long as you install and use your GMA as noted in this manual you should be fine NOTE The GMA device has been tested to comply with IEC 60601 1 2 2001 requirements for EMC with other devices 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 inte
8. instructions in this manual All repairs changes assembly operations and extensions are done only by Polymap Wireless 4 3 2 Compliance Statement Polymap Wireless states that this device conforms to FDA 21 CFR Parts 820 IEC 60601 1 Medical Electrical Equipment General Requirements for Safety IEC 60601 1 1 Medical Electrical Equipment Collateral standard Safety requirements for medical electrical systems IEC 60601 1 2 Medical Electrical Equipment Collateral standard Electromagnetic compatibility for medical electrical systems IEC 60601 1 4 Medical Electrical Equipment Collateral standard Programmable medical electrical systems UL 60601 Medical Electrical Equipment Part 1 General Requirements for Safety 8 25207 B June 2009 23 Polytel Glucose Meter Accessory GMA CSA Medical Electrical Equipment Part 1 C22 2601 No 601 1 M9 General Requirements for Safety The manufacturer of this device complied with the following requirements applicable at time of manufacture o ISO 13485 2003 o ISO 13485 8 under Canadian Medical Device Conformity Assessment System CMDCAS 4 4 About the label at the bottom of the GMA The label on the side of your GMA shows the unique ID number serial number of your device as well as some other things you might need to know IEC EN UL CAN ICSA 60601 1 60601 1 2 Contains FCC R47F2M03GL MONGI PNY DE OF IC 8229A F2M03GL FAS Use two CR2 Lithium ye
9. llow it to swing open 2 3 Size of your GMA 2 85 inches x 0 8 inches x 1 8 inches 72mm x 20mm x 45mm 3 Operating Instructions 3 1 Changing the batteries The GMA uses two Lithium CR2 size cell batteries that should last several months You can buy new Lithium CR2 size batteries at most drugstores or grocery stores Tip Your batteries will last longer if you remove them if you will not be using the GMA for a month or longer 8 25207 B 7 Jun 2009 T7 8 Polytel Glucose Meter Accessory GMA It is time to change the batteries when the red light on the GMA blinks fast for at least 10 seconds after a new reading Here is how you change the batteries 1 Open the battery compartment by sliding the lid in the direction indicated by the arrow labeled OPEN on the lid and let the lid open one Figure 3 Slide open the lid to change the batteries Positive end 2 the first Lithium CR2 size battery with the negative end down and the positive end up Negative end 3 Repeat step 2 for the second battery Note Always replace both batteries at the same time and make sure the batteries are from the same manufacturer 8 25207 B June 2009 9 Polytel Glucose Meter Accessory GMA IN Putting the batteries in backwards could make the device get hot or make the batteries leak Please pay attention to the instructions 4 Close the battery compartment by bringing the lid gently down
10. lucose meter in carrying case 8 25207 B June 2009 Polytel Glucose Meter Accessory GMA 3 Thread the cable through the mesh pocket in through the zippered opening and out through a hole in the mesh near the meter 4 Plug the cable from the GMA into the side of the glucose meter and press firmly into place Make sure that the clear plastic is not pinched this could prevent the cable from going in correctly NOTE Connect the GMA ONLY toa Bayer Contour Connecting it to any other device may make your readings inaccurate or damage one or both devices 5 Close and zip the case The next step is setting up the receiving station if this has not already been done 3 4 Placement of the GMA and receiving station Various types of barriers such as walls can reduce the range of wireless devices Your GMA will work best if it is in the same room as the receiving station Remember your receiving station is the separate box personal computer cell phone or handheld device Warning Do not put the GMA ona metal surface or in a metal box or 8 25207 B June 2009 14 Polytel Glucose Meter Accessory GMA enclosure This may interfere with its ability to send data When the devices are working together correctly the red light on the GMA comes on and starts blinking right after you take a new reading then goes out when the reading is sent See page 7 to learn more about the red light 3 5 How to use y
11. our GMA 1 Insert the glucose test strip into the glucose meter and take your reading as you normally would Instructions on using your Contour meter should have come with the original box 2 Remove the test strip as usual 3 After you remove the test strip a Press the M button on the meter b The Contour meter displays on the screen then some numbers and again This shows that it is sending the reading to the GMA 8 25207 B June 2009 15 8 25207 B Polytel Glucose Meter Accessory GMA Figure 6 shows on the glucose meter when the GMA is receiving your readings The GMA red light begins blinking off and on This means that it is sending your reading to the receiving station June 2009 16 Polytel Glucose Meter Accessory GMA After taking your glucose reading it may take a minute or two to send the reading to the receiving station Please be patient do not press any buttons or disconnect the GMA until the light has completely stopped blinking or your results may not be sent Figure 7 Blinking light usually means your information is being sent Please be patient IMPORTANT If glucose meter screen does not show or 7 the red light does not come on shortly after taking a new reading Check that the GMA cable is firmly plugged into the glucose meter Try replacing both batteries see page 8 25207 B June 2009 17 Polytel Glucose Me
12. rference and 2 This device must accept any interference received including interference that may cause undesired operation 8 25207 B June 2009 2 Polytel Glucose Meter Accessory GMA 6 4 System Availability If you end up needing to take a second reading shortly after a first reading it is probably easiest to wait until the indicator has turned off There is no problem with taking several readings while out of range of the receiving station The stored readings will all be sent the next time you take a new reading within range of the receiving station 1 Trademarks Bluetooth word mark and logos are owned by the Bluetooth SIG Inc Polytel is a registered trademark of Polymap Wireless LLC This product was designed solely by Polymap Wireless independent of Bayer maker of the Ascentia Contour glucose meter 8 25207 B June 2009 28 Polytel Glucose Meter Accessory GMA 8 Index access points changing 19 defined 5 availability 28 batteries 8 9 blinking light 6 7 Carrying case modifying 11 12 Case preparing 11 12 cleaning 26 compliance 22 23 connecting 13 devices cleaning 26 connecting 13 disconnecting 19 sharing 21 troubleshooting 20 using 15 disconnecting 19 electrical safety 22 electromagnetic compatibility 27 EMC 27 indicator light 6 7 installing 13 8 25207 B intended use 5 legal compliance 22 23 light indicator 6 7 major pa
13. rts 6 Meter carrying case 11 12 other devices 14 receiving station See access points regulatory compliance 22 23 repair 26 replacing batteries 8 9 retries 18 safety electrical 22 service 26 setting up 13 sharing devices 21 temperatures 27 trademarks 28 traveling 19 troubleshooting 20 using devices 15 June 2009 29
14. ter Accessory GMA See page 20 if you are still having problems When the GMA sends your information the power level of the batteries is sent along with your reading Your monitoring service may tell you it is time to replace the batteries even before you notice any problems That s it you don t have to do anything more After the reading reaches the receiving station the GMA light turns off A couple of minutes later the disappears from the glucose meter 3 6 If the Transmission Didn t Send If your transmission was not sent successfully the GMA will try again 1 minute later and then again 2 minutes later If all three tries fail the GMA saves the reading along with the time and date it was taken and turns itself off The next time you take a new reading it sends both the new and the stored readings Tip If you want to send the stored reading s without taking a new one 1 Press the M button on the meter You will see the come on as during a normal transmission 8 25207 B June 2009 18 Polytel Glucose Meter Accessory GMA Polytel Glucose Meter Accessory GMA 3 7 Disconnected glucose meter Any readings taken when the GMA is not 3 9 Troubleshooting connected to the glucose meter are stored along with the date and time taken The next time you Wrong It take a new reading after the devices are connected Red light again both the stored and new readings are sent to doesn t come
15. toward the batteries and sliding it in the direction opposite the OPEN arrow until the lid stops 5 If the red light still flashes for 10 seconds or longer repeat steps 1 through 4 and Check that you inserted the batteries in the right direction Try replacing with a different pair of Lithium CR2 size batteries If you are still having trouble see the Troubleshooting section on page 20 8 25207 B June 2009 10 Polytel Glucose Meter Accessory GMA 3 2 Preparing the carrying case The meter has a hole in the side for the GMA connector but the part of the case that holds it covers the hole so we need to prepare the case first 1 Prepare the carrying case The meter has a hole on the right side Place the meter in its case and mark the plastic covering the hole 2 Take out the meter 3 Cut a small hole in the plastic around the marked point see figure below 8 25207 B June 2009 11 Polytel Glucose Meter Accessory GMA 4 Cuta small slit no more than 4 in the mesh near the point shown by the arrow Cut small hole in side of i Cut 1 4 slit in mesh plastic cover Figure 4 modifications to the carrying case 8 25207 B June 2009 Polytel Glucose Meter Accessory GMA 3 3 Connecting the devices Before you can start using the GMA you need to connect it to the glucose meter 1 Insert the glucose meter 2 Insert the GMA into the zippered pouch DEO be Figure 5 g
16. up and use The most important part to pay attention to is the red light at the bottom right edge of the device Different blinking patterns tell you when the GMA is sending data whether it was sent successfully or not and when it is time to change the batteries 2 1 Red light The GMA has a small red indicator light that blinks in different patterns when it is doing different things Figure 1 Red light indicates status of the GMA 8 25207 B June 2009 6 Polytel Glucose Meter Accessory GMA Here are the possible light patterns and their meanings Light Looks Speed Like Length GMA is receiving re epee reading from glucose no blinking seconds meter Blinking 1 blink per ue connecung 19 receiving station second Please be patient 2 blinks per Very fast second for GMA sending data to blinking 1 2 receiving station seconds 2 blinks per Very fast second for Replace batteries blinking 10 See p 9 seconds 1 blink per Last attempt to send Slow blinking p data unsuccessful 10 seconds N Either Successfully sent data or Off n a Data not successfully sent will send with next reading See p 18 8 25207 B June 2009 re Polytel Glucose Meter Accessory GMA 2 2 Battery Compartment You can open the battery compartment by sliding the lid in the direction of the arrow then allowing it to swing open Figure 2 Battery lid Slide lid in direction of arrow and a
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