Polytel GMA Glucose Meter Accessory Model
Contents
1. Figure 4 PC shows on the OneTouch Ultra when the GMA is receiving your readings c The GMA red light begins blinking off and on This means that it is sending your reading to the receiving station July 2008 15 8 2520 2 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 5 Blinking light usually means your information is being sent Please be patient IMPORTANT If OneTouch Ultra screen does not show PC or the red light does not come on shortly after taking a new reading e Check that the GMA cable is firmly plugged into the OneTouch Ultra e Try replacing both batteries see page 8 July 2008 16 Polytel Glucose Meter Accessory GMA e 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 PC disappears from the OneTouch Ultra device 3 5 If the Transmission Didn t Send If your transm2. De ee ee Oe 22 4 3 COMPLIANCE INFORMATION ee ee 22 4 3 1 Compliance Requirements sesse esse 23 4 3 2 Compliance Statement ees ee 23 4 4 ABOUT THE LABEL AT THE BOTTOM OF THE GMA 24 5 OPERATOR MAINTENANCE ee ee ese seke eek ee 25 5 1 PERIODIC MAINTENANCE ee ee ee ee ee ee eed 25 5 2 CLEANING YOUR GMA ee ee ee ee ed 26 6 TECHNICAL SPECIFICATIONS 0ccsceeeeceeeees 26 8 2520 2 ae ddly 2008 1 2 Polytel Glucose Meter Accessory GMA 0 T BATTERIES ER ee ee ee De GO cade titi aiat 26 6 2 TEMPERATURES EG Ee ee eg Ge 27 6 3 COMPATIBILITY WITH OTHER ELECTRICAL MEDICAL EOWIPMEN Teraina st ans ee E ed Ge Ee 27 6 4 SYSTEMAVAILABILITY saei oe eed see darini eiaa 28 7 TRADEMABKS is esse duike ees des Gee ee ee de See de ee 28 O INDE X ot We ee Ge n Ee Ne ei ee DI N dee ee EN 29 8 2520 2 July 2008 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 LifeScan OneTouch Ultra glucose meter wirelessly to a receiving station This no more worrying about writing down the test results and carrying them in to your doctor every visit it is all done automatically in your own home There are three parts to sending your readin
3. IEC UL CAN CSA safety and the radio 60601 1 60601 1 2 requirements of these respective standards FCC QYPPWRO0801 FCC listing number for the device IC 4552A PWR0801 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 OneTouch Ultra device is not frayed or damaged 8 2520 2 July 2008 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 OneTouch Ultra 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 liquids may penetrate and damage the unit 3 Gently wipe the outside of the unit with the damp cloth 4 Reconnect the GMA to the OneTouch Ultra 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 e Only use CR2 Lithium batteries e Replace both batteries at the same time pr
4. Polytel Glucose Meter Accessory GMA pelymap wireless Polytel GMA Glucose Meter Accessory Model PWR 08 03 USER MANUAL Version 2 Polymap Wireless 310 S Williams Blvd Ste 346 Tucson Arizona 85711 520 747 1811 www polymapwireless com 8 2520 2 July 2008 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 Q ccceceeescecsceeneess 8 3 1 CHANGING THE BATTERIES ccecececcccecccccecececececerecs 8 3 2 CONNECTING THE DEVICES ccccccecececececececececess 11 3 3 PLACEMENT OF THE GMA AND RECEIVING STATION 14 3 4 HOW TO USE YOUR GMA cccccccecececececececececees 14 3 5 IF THE TRANSMISSION DIDN T SEND 2cececeeees 17 3 6 DISCONNECTED GLUCOSE METER sceccecececececenes 18 3 7 WHEN YOU RE TRAVELING cccccecececececececececececens 19 3 7 1 Traveling in France Spain or Japan 19 3 8 TROUBLESHOOTING ccccececececccccceceneceneceneneneneners 20 4 SAFETY INFORMATION esse kes es eek eke Nee ee Re Re 21 4 1 PATIENT SAFETY ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee 21 42 ELECTRICAL SAFE Ti Ee ens Ge
5. e mesh pocket 6 Close and zip the case The next step is setting up the receiving station if this has not already been done 8 2520 2 July 2008 13 Polytel Glucose Meter Accessory GMA 3 3 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 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 4 How to use your GMA 1 Insert the glucose test strip into the OneTouch Ultra glucose meter and take your reading as you normally would Instructions on using your OneTouch Ultra should have come with the glucose meter 2 Remove the test strip as usual 3 After you remove the test strip a The red light on the GMA turns on automatically 8 2520 2 July 2008 14 Polytel Glucose Meter Accessory GMA b The OneTouch Ultra displays PC on the screen This shows that it is sending the reading to the GMA The PC indication will stay on for two minutes This is normal
6. e red light still flashes for 10 seconds or longer repeat steps 1 through 4 and e Check that you inserted the batteries in the right direction e Try replacing with a different pair of Lithium CR2 size batteries If you are still having trouble see the Troubleshooting section on page 20 July 2008 10 Polytel Glucose Meter Accessory GMA 3 2 Connecting the devices Before you can start using the GMA you need to connect it to the OneTouch Ultra glucose meter 1 Slide the OneTouch Ultra into the clear plastic pocket in its carrying case 2 Put the cable from the GMA in the zippered mesh pocket of the carrying case 8 2520 2 July 2008 11 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 a 4 s MT E Pe ES a e gt gt Sea alee SU Ma Ie ve Tip If you are having trouble threading the cable through the mesh pocket try cutting a small slit no more than 1 4 inch in the mesh 4 Plug the cable from the GMA into the bottom of the OneTouch Ultra and press firmly into place _ H gin jack and press firmly into place 8 2520 2 July 2008 12 Polytel Glucose Meter Accessory GMA i NOTE Connect the GMA ONLY to a LifeScan OneTouch Ultra Connecting it to any other device may make your readings inaccurate or damage one or both devices 5 Put the GMA in th
7. eferably from the same manufacturer 8 2520 2 July 2008 26 Polytel Glucose Meter Accessory GMA 6 2 Temperatures e Use your GMA in temperatures ranging from 10 to 40 Celsius 50 to 104 Fahrenheit e Store your GMA in temperatures ranging from 40 to 70 Celsius 40 to 158 Fahrenheit e 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 interference and 2 This device must accept any interference received including interference that may cause undesired operation 8 2520 2 July 2008 27 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 PC indicator has turned off There is no problem with taking se
8. equirements for medical electrical systems e IEC 60601 1 2 Medical Electrical Equipment Collateral standard Electromagnetic compatibility for medical electrical systems e IEC 60601 1 4 Medical Electrical Equipment Collateral standard Programmable medical electrical systems e UL 60601 Medical Electrical Equipment Part 1 General Requirements for Safety e CSA Medical Electrical Equipment Part 1 C22 2601 No 601 1 M9 General Requirements for Safety 8 2520 2 July 2008 23 Polytel Glucose Meter Accessory GMA e 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 CSA 60601 1 pelymap wireless 60601 1 2 ei FCC QYPPWR0801 IC 4552A PWR0801 Use two CR2 Lithium batteries oR Assembled in USA A d C A N Mfg Date Stans S N Label on the bottom of the GMA 8 2520 2 July 2008 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
9. erent 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 2520 2 July 2008 6 Polytel Glucose Meter Accessory GMA Here are the possible light patterns and their meanings Light Looks Speed Like Length GMA is receiving rah Up to 20 3 no blinking seconds reading from OneTouch Ultra Blinking 1 blink per Ek cones 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 8 seconds 1 blink per Last attempt to send Slow blinking p data unsuccessful 10 seconds N Either e Successfully sent data or Off n a e Data not successfully sent will send with next reading See p 17 8 2520 2 July 2008 rf 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 allow 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 Operati
10. gs wirelessly e You measure your glucose on the LifeScan OneTouch Ultra glucose meter e The GMA receives the reading from the OneTouch Ultra and sends it wirelessly to the receiving station e The receiving station receives stores and sends your readings to your service provider usually your doctor s office or a monitoring service The station is a separate device that is either a self contained box 8 2520 2 July 2008 4 Polytel Glucose Meter Accessory GMA 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 OneTouch Ultra 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 2520 2 July 2008 5 Polytel Glucose Meter Accessory GMA 2 Parts of the GMA Your GMA is easy to maintain set up and use The most important part to pay attention to is the red light at the bottom right edge of the device Diff
11. ission 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 Insert a test strip as if you are taking a new reading 2 Remove the strip without taking a blood sample You will see the PC come on as during a normal transmission 8 2520 2 July 2008 17 Polytel Glucose Meter Accessory GMA 3 6 Disconnected glucose meter Any readings taken when the GMA is not connected to the OneTouch Ultra are stored along with the date and time taken The next time you take a new reading after the devices are connected again both the stored and new readings are sent to the receiving station 8 2520 2 July 2008 18 Polytel Glucose Meter Accessory GMA 3 7 When You re Traveling If you are not at home or near your regular receiving station the GMA can send the readings to a different station Please speak with your monitoring service to set this up 3 7 1 Traveling in France Spain or Japan The device uses several radio channels Some of these are not allowed in France Spain or Japan If you live in or plan to travel to these countries please contact Polymap Wireless 8 2520 2 July 2008 19 Polytel Glucose Me
12. ng 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 2520 2 7 July 2008 7 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 8 2520 2 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 Figure 3 Slide open the lid to change the batteries Positive end Insert the first Lithium CR2 size battery with the negative end down and the positive end up Negative end 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 July 2008 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 8 2520 2 Close the battery compartment by bringing the lid gently down toward the batteries and sliding it in the direction opposite the OPEN arrow until the lid stops If th
13. ter Accessory GMA 3 8 Troubleshooting What s What Caused What To Do Wrong It doesn t come batteries see p 8 on Disconnected Plug cable firmly cable into OneTouch Ultra see p 12 Cant send Receiving Move receiving even after station may station closer to several tries not be GMA or see light is on working manual for properly receiving station PC does not Weak missing Replace batteries show on batteries meter Disconnected Plug cable firmly cable into OneTouch Ultra see p 11 Send GMA to frayed cable Polymap Wireless for repair 8 2520 2 July 2008 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 One Touch Ultra 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 OneTouch Ultra glucose meter itself 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 2520 2 July 2008 21 Polytel Glucose Meter Accessor
14. veral 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 7 Trademarks e Bluetooth word mark and logos are owned by the Bluetooth SIG Inc e Polytel is a registered trademark of Polymap Wireless LLC e This product was designed solely by Polymap Wireless independent of LifeScan makers of the OneTouch Ultra 8 2520 2 July 2008 28 Polytel Glucose Meter Accessory GMA 8 Index access points changing 20 defined 6 availability 29 batteries 9 blinking light 7 cleaning 27 compliance 23 connecting 12 devices cleaning 27 connecting 12 disconnecting 19 sharing 22 troubleshooting 21 using 15 disconnecting 19 electrical safety 23 electromagnetic compatibility 28 EMC 28 indicator light 7 8 2520 2 installing 12 intended use 6 legal compliance 23 light indicator 7 major parts 7 other devices 14 PC on OneTouch 16 receiving station See access points regulatory compliance 23 replacing batteries 9 retries 18 safety electrical 23 setting up 12 sharing devices 22 temperatures 28 trademarks 29 traveling 20 troubleshooting 21 using devices 15 29
15. y 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 One Touch Ultra meter is approved for use by its manufacturer Polymap Wireless is not responsible for its diagnostic accuracy or its 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 2520 2 July 2008 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 e You use the equipment according to the instructions in this manual e 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 e FDA 21 CFR Parts 820 e IEC 60601 1 Medical Electrical Equipment General Requirements for Safety e IEC 60601 1 1 Medical Electrical Equipment Collateral standard Safety r
Download Pdf Manuals
Related Search