User manual

ManualsBrandsAbbott ManualsBlood Glucose MeterFreeStyle Lite

Polytel

Glucose Meter Accessory (GMA)

8-25207-B June 2009 1 - 1 - - 1 - - 1 -

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

Polytel

Glucose Meter Accessory (GMA)

8-25207-B June 2009 2

Table of Contents

1 INTRODUCTION..........................................................4

1.1 OVERVIEW ..............................................................4

1.2 WHO IS THIS FOR?...................................................5

2 PARTS OF THE GMA .................................................6

2.1 RED LIGHT ..............................................................6

2.2 BATTERY COMPARTMENT ........................................8

2.3 SIZE OF YOUR GMA ................................................8

3 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 DIDN’T SEND ................................17

3.7 DISCONNECTED GLUCOSE METER...........................18

3.8 WHEN YOU’RE TRAVELING.....................................18

3.8.1 Traveling in France, Spain, or Japan ..........18

3.9 TROUBLESHOOTING...............................................19

4 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.....23

5 OPERATOR MAINTENANCE...................................24

5.1 PERIODIC MAINTENANCE .......................................24

5.2 CLEANING YOUR GMA...........................................25

Summary of content (14 pages)

PAGE 1
Polytel® Glucose Meter Accessory (GMA) Polytel® Glucose Meter Accessory (GMA) Table of Contents 1 INTRODUCTION..........................................................4 Polytel® GMA Glucose Meter Accessory for Abbott® FreeStyle® Lite and FreeStyle® Freedom® Lite Model PWR-08-09 USER MANUAL Version: B 1.1 OVERVIEW ..............................................................4 1.2 WHO IS THIS FOR?...................................................5 2 PARTS OF THE GMA ....................................
PAGE 2
Polytel® Glucose Meter Accessory (GMA) Polytel® Glucose Meter Accessory (GMA) 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............................................27 7 TRADEMARKS..............
PAGE 3
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 FreeStyle meter as usual. Everything else is done automatically for you.
PAGE 4
Polytel® Glucose Meter Accessory (GMA) Here are the possible light patterns and their meanings: Light Looks Like… Speed / Length On (no blinking) Up to 20 seconds Blinking 1 blink per second Very fast blinking Very fast blinking Slow blinking Off 8-25207-B 2 blinks per second for 1-2 seconds 2 blinks per second for 10+ seconds 1 blink per 10 seconds n/a June 2009 Polytel® Glucose Meter Accessory (GMA) 2.
PAGE 5
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. Polytel® Glucose Meter Accessory (GMA) Putting the batteries in backwards could make the device get hot or make the batteries leak. Please pay attention to the instructions.
PAGE 6
Polytel® Glucose Meter Accessory (GMA) 3.2 Preparing the carrying case 3.3 Connecting the devices 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 ¼“in the mesh near the point shown by the arrow. Before you can start using the GMA, you need to connect it to the glucose meter.
PAGE 7
Polytel® Glucose Meter Accessory (GMA) 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. goes out when the reading is sent. See page 7 to learn more about the red light. 4) Plug the cable from the GMA into the side of the glucose meter and press firmly into place. 3.5 How to use your GMA NOTE: Connect the GMA ONLY to a FreeStyle® Lite or FreeStyle® Freedom® Lite meter.
PAGE 8
Polytel® Glucose Meter Accessory (GMA)  Figure 6 All display segments light up, then a single reading shows on the meter when the GMA is receiving your readings. 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. c. The GMA red light begins blinking off and on.
PAGE 9
Polytel® Glucose Meter Accessory (GMA) See page 19 if you are still having problems. Polytel® Glucose Meter Accessory (GMA) 3.7 Disconnected glucose meter 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.
PAGE 10
Polytel® Glucose Meter Accessory (GMA) 4 Safety Information 3.9 Troubleshooting What’s Wrong? Red light doesn’t come on What Caused It? Weak/missing batteries Disconnected cable Can’t send even after several tries (light is on) Receiving station may not be working properly Weak/missing batteries Disconnected cable Meter display does not come on as in Figure 6 Damaged or frayed cable Polytel® Glucose Meter Accessory (GMA) We are committed to your safety. Please read these warnings and cautions.
PAGE 11
Polytel® Glucose Meter Accessory (GMA) 4.3.1 Compliance Requirements 4.2 Electrical Safety 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. Only authorized maintenance staff should disassemble the GMA. (This does not include changing the batteries.
PAGE 12
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) Polytel® Glucose Meter Accessory (GMA) Seal / Mark Meaning Device was tested to comply with the U.S. and Canadian safety directives.
PAGE 13
Polytel® Glucose Meter Accessory (GMA) If your GMA needs repair or is not working right, contact Polymap Wireless for service right away. 6.2 Temperatures 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.
PAGE 14
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 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.