GMA2-L for LifeScan OneTouch ® Ultra ® Ultra ® 2, and UltraMini
Contents
1. 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 Device was tested to comply with the CE EMC and low power directives AN You should read accompanying documents before use Device uses Bluetooth 2 1 FCC FCC listing number for the QYPPWR0902 device IC Industry Canada listing number 4552A PWR0902 for the device S N Unique serial number 0015B4010204 9 2520 A September 2013 22 Polytel GMA2 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 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 t2. 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 glucose meter screen does not show PC or the light does not come on shortly after taking a new reading e Check that the GMA cable is firmly plugged into the glucose meter e Try replacng both batteries see page 10 See page 20 if you are still having problems 9 2520 B January 2014 17 Polytel GMA2 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 couple of minutes later the PC disappears from the glucose meter 3 6 If the data was not sent 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 3 7 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 tim
3. made to the product unless expressly approved by Polymap Wireless LLC could void the user s license for and the warranty of the device 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 Medical Devices per 21CFR and under the low power directive for CE 9 2520 A September 2013 20 Polytel GMA2 The various glucose meters are approved for use by their manufacturer Polymap Wireless is not responsible for their diagnostic accuracy or their electrical safety 4 3 Compliance Information This section is about the telemetry system regulatory compliance requirements and the manufacturer s responsibilities 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 R amp TTE Directive 1999 5 EC EN 300 328 V1 7 1 EN 301 489 1 V1 9 2 EN 301 489 17 V2 2 1 e EMC Directive 2004 108 EC EN 61326 1 2006 The manufacturer of this device complied with the following reguirements applicable at time of 9 2520 B January 2014 21 Polytel GMA2 manufacture e ISO 13485 2003 e ISO
4. remove the test strip The blue light on the GMA turns on automatically The meter will show activity e LifeScan meters display 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 e Bayer meters show the number of measurements e 9 2520 A September 2013 14 Polytel GMA2 counting down The display will stay on for two minutes This is normal Abbott meters show all the display elemets active nothing readable Figure 4 PC shows on the glucose meter when the GMA is receiving your readings 4 The GMA blue light begins blinking off and on This means that it is sending your reading to the receiving station 9 2520 B January 2014 15 Polytel GMA2 NOTE Some meters automatically wake up the GMA For those that do not please see chart below OneTouch Ultra OneTouch Ultra2 Automatic versions amp B OneTouch Ultra2 Manual Press the button newer versions on the GMA OneTouch Ultra Automatic Mini Easy OneTouch Select Manual Press the button Basic on the GMA Bayer Contour Some are Press the M Breeze2 automatic some button on the are manual meter itself Abbott FreeStyle Manual Press the button on the GMA 9 2520 A September 2013 16 Polytel GMA2 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
5. Polytel GMA2 9 pelymap wireless Polytel GMA2 Glucose Meter Accessory Model PWR 09 02 USER MANUAL Version B 310 S Williams Blvd Ste 230 Tucson Arizona 85711 1 520 747 1811 Mon Fri 9AM 5PM MST www polymapwireless com 9 2520 B January 2014 1 Polytel GMA2 Contents LInrodu iansess amsn 4 1 1 Overview ss 4 1 2 Who is this for 5 133 Configuration S riseta Y trie tienen 5 ee Pease ER FFF FFR eee 6 2 Parts of the GMA aunt 6 2 Visual indicators s oieee siainen aaeei 7 2 2 Battery Compartment nennen nennen eene eenn 9 2 3 Size of your GMA 9 3 Operating Instructions 9 3 1 Changing the batteries nnen eenen vennen 9 3 2 Connecting the devices 11 3 3 Placement of the GMA and receiving station 13 34 PAIN T Qi ESA NOE FEN DF HR FFON NR EE 14 3 5 How to use your GMA 14 3 6 If the data was not sent 18 3 7 Disconnected glucose meter 18 4 Safety lnformatiGrl GG Gw Gw 20 4 1 Patient Safety 20 4 3 Compliance Information 21 5 Operator Maintenance 23 5 1 Periodic Maintenance 23 5 2 Cleaning your GMA nnen nennen 23 6 Technical Specifications 24 6 1 Balleli6 8 ciki aia uu con iog ultimes LLEF Ab on 24 6 2 TemperatulT Si ser i terdege 24 6 3 Compatibility with other electr
6. d 2 this device must accept any interference including interference that may cause undesired operation of the device Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploitation est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement 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 indicators on the meter have 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 9 2520 B January 2014 25 Polytel GMA2 7 Trademarks Bluetooth word mark and logos are owned by the Bluetooth SIG Inc e Polytel is a registered trademark of Polymap Wireless LLC e Ultra Ultra2 and UltraMini are registered trademarks of LifeScan Inc e CONTOURS BREEZE 2 are registered trademarks of Bayer e FreeStyle is a registered trademark of Abbott Diabetes Care 9 2520 A September 2013 26 Polytel GMA2 9 2520 B January 2014 27
7. e you take a new reading after the devices are connected again both the stored and new readings are sent to the receiving station 3 8 Troubleshooting 9 2520 A September 2013 18 Polytel GMA2 What s wrong What caused it What to do Blue light doesn t Weak missing Replace come on batteries batteries see p 10 Disconnected Plug cable firmly cable into glucose meter see p 14 GMA needs Please see p 17 manual operation to start Can t send even Receiving station Move receiving after several tries may not be station closer light is on working properly to GMA or see manual for receiving station No response on WeaK missing Replace meter display batteries batteries see p 10 Disconnected Plug cable firmly cable into glucose meter see p 14 Damage or Send GMA frayed cable to Polymap Wireless for repair 9 2520 B January 2014 19 Polytel GMA2 4 Safety Information We are committed to your safety Please read these warnings and cautions NOTE Disregarding the safety information provided is considered abnormal use 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 NOTE Polymap Wireless is not responsible for the reading diagnosis or electrical safety of the glucose meter itself The Polytel GMA is a data transmission system only WARNING Changes
8. he unit with the damp cloth 4 Reconnect the GMA to the glucose meter see page 14 and close the mesh pocket 9 2520 B January 2014 23 Polytel GMA2 6 Technical Specifications 6 1 Batteries The GMA uses two AAA cells 1 5V each Max Power consumption 0 5W 6 2 Temperatures e Use your GMA in temperatures ranging from 5 to 40 Celsius 41 to 104 Fahrenheit Store your GMA in temperatures ranging from 40 to 70 Celsius 40 to 158 Fahrenheit e Ifyou 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 eguipment Like other electrical medical eguipment the GMA unit reguires 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 9 2520 A September 2013 24 Polytel GMA2 This device complies with part 15 of the FCC Rules Operatio 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 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 an
9. ical medical equipment 9 2520 A September 2013 2 Polytel GMA2 24 6 4 System Availability annen 25 7 Trademarks 26 9 2520 B January 2014 3 Polytel GMA2 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 glucose meter wirelessly to a receiving station 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 readings wirelessly You measure your glucose on the LifeScan glucose meter e The GMA receives the reading from the meter 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 called an access point or your personal computer cell phone or handheld computer provided by your monitoring service Your monitoring service can 9 2520 A September 2013 4 Polytel GMA2 explain how to use the receiving station To use the GMA all you have to do is take the reading using LifeScan meter as usual Everything else is done automaticall
10. if you will not be using the GMA for a month or longer It is time to change the batteries when the red light on 9 2520 B January 2014 9 Polytel GMA2 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 see figure 2 Figure 3 Batteries should go in like this 2 Insert the batteries as shown in Figure 3 Note Always replace both batteries at the same time and make sure the batteries are from the same manufacturer 3 Close the battery compartment by sliding it back into place 4 If the red light still flashes for 10 seconds or longer repeat steps 1 through 3 and e Check that you inserted the batteries in the right direction Try replacing with a different pair of AAA size 9 2520 A September 2013 10 Polytel GMA2 batteries If you are still having trouble see the Troubleshooting section on page 19 3 2 Connecting the devices Before you can start using the GMA you need to connect it to the glucose meter 1 Slide the meter into the carrying case 2 Place the GMA in the carrying case Many different cases are provided by the manufacturers so details will vary Ultra2 9 2520 B January 2014 11 Polytel GMA2 Contour next EZ FreeStyle Lite 9 2520 A September 2013 12 Polytel GMA2 Plug in jack and press firmly into place 3 Plug the cable from the GMA int
11. o glucose meter and press firmly into place NOTE Connect the GMA ONLY to the meters approved for your configuration Connecting it to any other device may make your readings inaccurate or damage one or both devices 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 on a metal surface or in a 9 2520 B January 2014 13 Polytel GMA2 metal box or enclosure This may interfere with its ability to send data When the devices are working together correctly the 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 9 to learn more about the indicator light 3 4 Pairing In most cases Bluetooth pairing is initiated automatically by the GMA Receiving station should be pairable For HDP use you can make the GMA pairable by pressing the button three times making the GMA light blink red at one second intervals 3 5 How to use your GMA 1 Insert the glucose test strip into the glucose meter and take your reading as you normally would Instructions on using your glucose meter should have come with the original box 2 Remove the test strip as usual 3 After you
12. ual indicators The GMA has small blue and red indicator lights in the pushbutton that blink in different patterns when it is doing different things Figure 1 Indicator light indicates status of the GMA It may appear as blue or red depending see next page 9 2520 B January 2014 7 Polytel GMA2 Here are the possible light patterns and their meanings Light looks like Speed Length Blue on Up to 60 GMA is getting data no blinking seconds from glucose meter Blue blinking 1 blink per GMA connecting second to receiver Please wait Blue very fast 2 blinks per GMA sending data blinking second for to receiving station 1 2 seconds Blue Slow 1 blink per 10 Last transmit blinking seconds attempt did not work waiting to retry Red blinking 1 blink per Data not second successfully sent will send with next reading see page 19 Red very fast 2 blinks per Replace batteries blinking second for see page 10 10 seconds Successfully sent data 9 2520 A September 2013 8 Polytel GMA2 2 2 Battery Compartment You can open the battery compartment by sliding the lid on the bottom open with your thumb Figure 2 battery lid 2 3 Size of your GMA 4 25 inches x 1 1 inches x 0 62 inches 108mm x 28mm x 16mm 3 Operating Instructions 3 1 Changing the batteries The GMA uses two alkaline AAA batteries that should last a couple of months Tip Your batteries will last longer if you remove them
13. y 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 1 3 Configurations The GMA is available in three different configurations which determine which glucose meters are supported Configurations are selected by inserting the proper cable into the GMA Cable must be firmly inserted until flush 9 2520 B January 2014 5 Polytel GMA2 GMA2 L for LifeScan meters using L cable OneTouch Ultra OneTouch Ultra2 OneTouch UltraMini OneTouch UltraEasy OneTouch Select OneTouch Basic GMA2 B for Bayer meters using B cable Contour Contour TS Contour XT Contour NEXT Breeze2 GMA2 A for Abbott meters using A cable FreeStyle Lite FreeStyle Freedom Lite 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 indicator light on the device Different blinking patterns tell you when the GMA is sending data whether it was sent 9 2520 A September 2013 6 Polytel GMA2 successfully or not and when it is time to change the batteries 2 1 Vis
Download Pdf Manuals
Related Search