Polytel Glucose Meter Accessory (GMA)

Table of Contents

1 INTRODUCTION...4 1.1 OVERVIEW..4 1.2 WHO IS THIS FOR?...PARTS OF THE GMA..6 2.1 RED LIGHT..6 2.2 BATTERY COMPARTMENT..8 2.3 SIZE OF YOUR GMA..OPERATING INSTRUCTIONS.8 3.1 CHANGING THE BATTERIES..8 3.2 PREPARING THE CARRYING CASE..11 3.3 CONNECTING THE DEVICES.12 3.4 PLACEMENT OF THE GMA AND RECEIVING STATION.13 3.5 HOW TO USE YOUR GMA..14 3.6 IF THE READING DIDNT SEND..17 3.7 DISCONNECTED GLUCOSE METER..18 3.8 WHEN YOURE TRAVELING..18 3.8.1 Traveling in France, Spain, or Japan..18 3.9 TROUBLESHOOTING..SAFETY INFORMATION..20 4.1 PATIENT SAFETY...20 4.2 ELECTRICAL SAFETY..21 4.3 COMPLIANCE INFORMATION..21 4.3.1 Compliance Requirements.22 4.3.2 Compliance Statement..22 4.4 ABOUT THE LABEL AT THE BOTTOM OF THE GMA..OPERATOR MAINTENANCE..24 5.1 PERIODIC MAINTENANCE..24 5.2 CLEANING YOUR GMA..25
Polytel GMA Glucose Meter Accessory for Abbott FreeStyle Lite and FreeStyle Freedom Lite Model PWR-08-09 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 - 2009- 1 June

6 TECHNICAL SPECIFICATIONS.25 6.1 BATTERIES..25 6.2 TEMPERATURES..26 6.3 COMPATIBILITY WITH OTHER ELECTRICAL MEDICAL EQUIPMENT...26 6.4 SYSTEM AVAILABILITY..TRADEMARKS...INDEX..28

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 FreeStyle glucose meter wirelessly to a receiving station. This GMA is designed for the FreeStyle Lite and FreeStyle Freedom Lite glucose meters. No more worrying about writing down the test results and carrying them in to your doctor every visitit is all done automatically in your own home. There are three parts to sending your readings wirelessly: You measure your glucose on the FreeStyle 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 doctors 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 explain how to use the receiving station. To use the GMA, all you have to do is take the reading using your FreeStyle 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.

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. 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. It also has a START () button.

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.
Figure 1: Red light on lower right indicates status of the GMA. Square button with white triangle is Start button.
Here are the possible light patterns and their meanings: Light Looks Like On (no blinking) Blinking Speed / Length Up to 20 seconds 1 blink per second 2 blinks per second for 1-2 seconds 2 blinks per second for 10+ seconds 1 blink per 10 seconds It means GMA is receiving reading from glucose meter GMA connecting to receiving station. Please be patient. GMA sending data to receiving station. Replace batteries. (See p. 8.) Last attempt to send data unsuccessful, waiting to retry. Either: Successfully sent data. or: Data not successfully sent, will send with next reading. (See p. 17.)

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:
Very fast blinking Very fast blinking Slow blinking
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 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.

June 2009 -7-

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.
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 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 19.

Figure 3: Slide open the lid to change the batteries
the first Lithium CR2-size battery with the negative end () down and the positive end (+) up.
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.
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) Cut a small slit (no more than in the mesh near the point shown by the arrow.
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
Figure 4: modification to the carrying case. Please note different position of slit for FreeStyle Freedom case.
Figure 5: glucose meter and GMA in carrying case. Above: FreeStyle Lite and FreeStyle Freedom Lite. Note different position of GMA to make closing cover easier with larger meter
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. NOTE: Connect the GMA ONLY to a FreeStyle Lite or FreeStyle Freedom Lite meter. Connecting it to any other device may make your readings inaccurate or damage one or both devices. 2) Close and zip the case. The next step is setting up the receiving station if this has not already been done.
goes out when the reading is sent. See page 7 to learn more about the red light.

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 FreeStyle 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 START () button on the GMA b. The FreeStyle meter lights up all of its display (see below) then transitions to a simpler display with a single reading. This shows that it is sending the reading to the GMA.
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 on a 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

Figure 6 All display segments light up, then a single reading shows on the meter when the GMA is receiving your readings.
After taking your glucose reading, it may take a minute or two to send the reading to the receiving station. Please be patientdo not press any buttons or disconnect the GMA until the light has completely stopped blinking or your results may not be sent.
c. The GMA red light begins blinking off and on. This means that it is sending your reading to the receiving station.
Figure 7: Blinking light usually means your information is being sent. Please be patient.
IMPORTANT: If glucose meter screen does not look like Figure 6 or 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).
See page 19 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. Thats ityou dont have to do anything more. After the reading reaches the receiving station, the GMA light turns off. A couple of minutes later, the glucose meter display turns off.
3.7 Disconnected glucose meter
Any readings taken when the GMA is not connected to the glucose meter 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.

3.8 When Youre Traveling

If you are not at home or near your regular receiving station, the GMA can send the readings to a different access point. Please speak with your monitoring service to set this up.
3.6 If the Reading Didnt Send
If your reading 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 START () button on the GMA You will see the display come on, as during a normal transmission
3.8.1 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.

3.9 Troubleshooting

Whats Wrong? Red light doesnt come on Cant send even after several tries (light is on) Meter display does not come on as in Figure 6 What Caused It? Weak/missing batteries Disconnected cable Receiving station may not be working properly Weak/missing batteries Disconnected cable Damaged or frayed cable What To Do Replace batteries (see p. 8). Plug cable firmly into glucose meter (see p. 12). Move receiving station closer to GMA or see manual for receiving station. Replace batteries (see p. 8). Plug cable firmly into glucose meter (see p. 11). Send GMA to Polymap Wireless for repair.

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. NOTE: Polymap Wireless is not responsible for the reading, diagnosis, or electrical safety of the FreeStyle glucose meter itself. The Polytel GMA is a data transmission system only. 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. CAUTION! Only use Lithium CR2-size batteries. Using any other type of battery may cause an explosion.

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 II Medical Devices per 21CFR. The FreeStyle meters are approved for use by their manufacturer. Polymap Wireless is not responsible for their diagnostic accuracy or their electrical safety. 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.
4.3.1 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 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
4.3 Compliance Information
This section is about the telemetry system regulatory compliance requirements and the manufacturers responsibilities.

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)

Seal / Mark

Meaning 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.
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/UL/CAN/CSA 60601-1 60601-1-2 FCC: R47F2M03GL IC: 8229A-F2M03GL S/N: 0015B4010204
Device complies with both the safety and the radio requirements of these respective standards. FCC listing number for the device. Industry Canada listing number for the device Unique serial number

5 Operator Maintenance

5.1 Periodic Maintenance
Figure 8: Label on the bottom of the GMA
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.

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.

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 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 glucose meter (see page 11), and close the mesh pocket (see page 13).
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.
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.

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 meter display has turned off which could take two minutes. 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.

8 Index

access points changing, 18 defined, 5 availability, 27 batteries, 8, 9 blinking light, 6, 7 Carrying case, modifying, 11 Case, preparing, 11 cleaning, 25 compliance, 21, 22 connecting, 12 devices cleaning, 25 connecting, 12 disconnecting, 18 sharing, 20 troubleshooting, 19 using, 14 disconnecting, 18 electrical safety, 21 electromagnetic compatibility, 26 EMC, 26 indicator light, 6, 7 installing, 12 intended use, 5 legal compliance, 21, 22 light indicator, 6, 7 major parts, 6 Meter carrying case, 11 other devices, 13 receiving station. See access points regulatory compliance, 21, 22 repair, 25 replacing batteries, 8, 9 retries, 17 safety electrical, 21 service, 25 setting up, 12 sharing devices, 20 temperatures, 26 trademarks, 27 traveling, 18 troubleshooting, 19 using devices, 14

7 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 Abbott, maker of the FreeStyle glucose meters.

FreeStyle Lite Glucose

Summary of an evaluation under the direction of SKUP Report SKUP/2007/64
Background FreeStyle Lite blood glucose meter and FreeStyle Lite test strips are designed for glucose selfmeasurements performed by diabetes patients. The meter and the test strips are produced by Abbott Diabetes Care Inc. and are supplied in Scandinavia by Abbott. FreeStyle Lite blood glucose meter and FreeStyle Lite test strips was launched onto the Norwegian market the 1st of October 2007. In order to give reimbursement for the test strips in Norway, the Norwegian Labour and Welfare Organisation (NAV) requires from the companies to carry out an evaluation that includes a user-evaluation among diabetes patients. The evaluation of FreeStyle Lite was done under the direction of SKUP from May to June 2007. The aim of the evaluation The aim of the evaluation of FreeStyle Lite is to - reflect the analytical quality under standardised and optimal conditions, performed by biomedical laboratory scientists in a hospital environment - reflect the analytical quality by the intended users - compare the analytical quality among trained and un-trained diabetes patients - compare the analytical quality among diabetes patients before and after three weeks of practice - check the variation between three lots of test strips - examine if hematocrit interferes with the measurements - evaluate FreeStyle Lite regarding user-friendliness - evaluate the FreeStyle Lite user guide Materials and methods 82 diabetes patients took part in the evaluation. Half of the diabetes patients had two consultations (the training group) and the rest of them had one consultation (the mail group). The diabetes patients in the training group were given a standardised instruction about FreeStyle Lite before they did a finger prick and performed two measurements on the meter. The biomedical laboratory scientist also collected capillary samples from the diabetes patients and measured twice on FreeStyle Lite. In addition, two capillary samples were taken for measurements with a designated comparison method. The diabetes patients in the mail group received FreeStyle Lite by mail and no training was given. Both groups of diabetes patients used the equipment for approximately three weeks at home, before they were called for a final consultation. The blood glucose sampling and measurement procedures at the first consultation were repeated, and in addition a sample for hematocrit was taken. Three different lots of test strips were used in the evaluation. All the participants answered questionnaires about the userfriendliness and the user guide of FreeStyle Lite. Results - The precision of FreeStyle Lite was good. The repeatability CV was between 2 and 3 % under standardised and optimal measuring conditions and approximately 4 % when the measurements were performed by the diabetes patients. - The trueness of FreeStyle Lite was acceptable. For glucose values < 7 mmol/L no significant bias between FreeStyle Lite and the comparison method was pointed out. For glucose values > 7 mmol/L there was a small, but statistically significant bias between FreeStyle Lite and the comparison method. FreeStyle Lite gave glucose values
approximately 0,3 mmol/L lower than the comparison method for glucose values mmol/L and approximately 0,8 mmol/L lower than the comparison method for glucose values > 10 mmol/L. The agreement with a designated comparison method was good. The quality goal set in ISO 15197 was achieved under standardised and optimal measuring conditions. When handled by the diabetes patients, FreeStyle Lite also showed accurate results. These results were within the adjusted ISO-goal and also within the quality goal set in ISO 15197. Two of the three lots of test strips used in this evaluation gave significantly lower values than the comparison method. The third lot of test strips gave significantly higher values than the comparison method. The deviations are small, but statistically significant. Glucose measurements on FreeStyle Lite did not seem to be affected by hematocrit in this study. Hematocrit outside the range % has not been tested. The diabetes patients summarised the FreeStyle Lite device as easy to use. Most of them were pleased with the device. Most of the diabetes patients that had used the user guide were satisfied with the guide.

Conclusion The analytical quality of FreeStyle Lite was good. The precision of FreeStyle Lite was good. The results were accurate and within the quality goal for the total error set in the ISO-guide 15197. The glucose results did not seem to be affected by hematocrit in this study. The users found the FreeStyle Lite device easy to use and they were quite satisfied with the device.
Comments from Abbott There is no additional information from producer attached to the report.
The complete report is found at www.skup.nu