Blood Glucose Monitoring System GM550 BIONIME GmbH Tramstrasse 16, 9442 Berneck Switzerland 0197 101-3GM550-231 EN BIONIME CORPORATION 694, Renhua Road, Dali City, Taichung County, Taiwan 412 Tel: +886 4 24951268 Fax: +886 4 24952568 http: //www.bionime.com E-mail: info@bionime.
Preface Intended Use TM Thank you for choosing the Rightest Blood Glucose Monitoring System GM550. Please read this manual thoroughly before testing. It provides all information you need to use the product. TM TM The Rightest Blood Glucose Meter GM550 must only be used with Rightest Blood Glucose Test Strip GS550 and Control Solution. The application of other Test Strips or control solutions can lead to incorrect results.
Table of Contents Table of Contents TM About Rightest GM550 System TM Package of Rightest GM550 System Kit Quality Control 6 TM 8 Precaution 12 RightestTM GS550 Test Strip 14 Rightest GM550 Meter Being Ready for Test 32 Review Your Test Memory Performing a Quality Control Test Recalling Test Result and Average 34 37 Meter activation and Battery change 16 Setting Up Your Meter- Setting the Time, Volume and Date 18 Turning On/Off the Metert 22 Error Messages and Trouble Shooting Turning o
Package of RightestTM GM550 System Kit Your RightestTM Blood Glucose Monitoring System GM550 consists of several items. Please identify each item of your system and learn what they're called and how they're used. These items are included in your RightestTM Blood Glucose Monitoring System GM550: 1. RightestTM GM550 Meter (with 2 CR2032 batteries installed) 2. RightestTM GS550 Test Strips (0/10/25 pcs)＊ 3. Getting Started Guide 4. RightestTM GM550 User Manual 5. RightestTM GS550 Test Strips Package Insert＊ 6.
RightestTM GM550 Meter RightestTM GM550 Meter Test Strip Port Insert test strip here until you hear a click. GM550 Battery Cover Slide cover to change batteries. Display Window Show your test result, messages and relative information. Main Button ( ) For operating the meter, please check details in following sections. Left Button ( ) For operating the meter, please check details in following sections.
RightestTM GM550 Meter RightestTM GM550 Meter Indicates a test result stored in memory Tell when to apply the blood sample Indicates a test result, not joining into the Average function of this meter Test strip Indicates with the average result Warns when using the strip, not suitable for your region test, or strip error Indicates a control solution test result Current date under time mode or Testing date under memory mode Unit of test result Indicates if the environmental temperature is exceeded
Precaution Precaution TM - Before using the Rightest GM550 BGMS to test your blood glucose, please read instructions for use. TM TM - The Rightest GM550 Meter is only compatible with the Rightest GS550 Test Strip. TM TM The Rightest GM550 Meter must only be used with Rightest GS550 Test Strip and RightestTM Control Solution. The application of other Test Strips or control solutions can lead to incorrect results. TM - Rightest GM550 BGMS is intended for self-testing.
GS550 Test Strip GS550 Test Strip The RightestTM GM550 Meter must only be used with RightestTM GS550 Test Strips and RightestTM Control Solution. The application of other Test Strips or control solutions can lead to incorrect results. Sample Entry Apply a drop of blood or control solution here. The test request is only 1.0 µL of blood. Noble Metal Electrodes Electrochemical sensor Indication Symbol Insert strip with indication symbol up and toward meter.
Meter activation and Battery Change Meter activation and Battery change Your meter comes with two CR2032, 3volt, batteries installed. Two new batteries will provide power to perform about 1000 tests under normal use. You can press the main button or insert a strip to activate your meter. 1. Turn the meter over. Press and push battery cover to open. 2. Install the batteries. Be sure to put battery in correct direction. 3. Slide the battery cover back until it snaps into place. 4.
Setting Up Your Meter- Setting the Time, Volume and Date You can enter Setting Mode by below two ways. 1. Reload battery After removing the battery, please press the main button for several times until no signal on screen, then follow the battery installation steps to load batteries. The meter will do self test. Press the main button to exit the self test and enter Setting Mode. 2. With Battery inserted Press the main button first to turn on the meter.
Setting Up Your Meter- Setting the Time, Volume and Date 4a) 4. Time format 12/24H selection With the time format blinking, press the Left or Right button to adjust it. Then press the Main button to confirm it and move to hours setting. 5. Hour setting With the hour blinking, press the Left or Right button until the current hour appears. Then press the Main button to confirm it and move to minute setting. 4b) 5) 6) 7a) 7b) 6.
Turning on /off the Backlight Turning On/Off the Meter 1. How to turn on the Meter Press the Main button or Insert a test strip. 1. How to turn on the Backlight Keep pressing the Main button for 2 seconds. 2. Manual Power off If you want to turn off the meter, please keep pressing the Main button for 4 seconds. 2. Manual Backlight off If you want to turn off the backlight, please keep pressing the Main button for another 2 seconds. 3.
Performing a Blood Test Depth adjustable cap Performing a Blood Test 1 Release button Plunger Lancet carrier Hub 1. Hold the depth adjustable cap in one hand and hold the hub in the other hand. Bend the cap towards the down side. When a gap appears between the cap and hub, pull them off in opposite directions. 2 3 4. Twist off and set aside the protective cover of the disposable lancet. 5. Replace the depth adjustable cap. 24 7. Hold the hub in one hand and pull on the plunger in the other hand.
Performing a Blood Test Performing a Blood Test 11 11. A blood drop symbol appears and is accompanied by a further beep (if volume is turned on). Now you can apply the blood sample within 2 minutes. 12 12. Place the lancing device against your fingertip and press the release button. 13. Touch and hold the drop to the edge of sample entry until you hear a " beep " (if volume is turned on) and the View Window is totally filled with blood.
Alternative Site Testing (AST) Alternative Site Testing (AST) Alternative site testing-palm or forearm blood sampling 1. Choose Clear Cap and follow step 1~5 on page 24. 2. Massage the puncture area of palm or forearm for a few seconds. 3. Immediately after massaging the puncture area, press and hold the lancing device with the Clear Cap against palm or forearm. 4. Then press the release button. 5.
View Window appearance “Lo” and “Hi” readings Make sure your blood sample covers the whole area of the View Window to get an accurate test result. An insufficient blood sample will result in an error message ("Er4"). If this occurs, repeat the test with a new test strip. Insufficient blood sample Enough blood sample PRECAUTION - Check the expiration date printed on the strip vial every time you use a test strip. Do not use expired test strips.
Quality Control Test Quality Control Test Please use Control Solution tested with RightestTM GM550 BGMS under Control Solution Mode. If the test result is within the Control Solution Range printed on the strip vial label, the RightestTM GM550 BGMS passes Quality Control Test. That means your RightestTM GM550 BGMS is working correctly. Control Solution Range: Test Strips Control Solution Range: 83-113 mg/dL 4.6-6.3 mmol/L Example of Control Solution Range printed on your test strip vial label.
Performing a Quality Control Test 1. Take one test strip from vial and Re-cap the vial cap immediately. Performing a Quality Control Test 1 2 9. Tightly replace the cap on the Control Solution bottle. 2. Insert the test strip with view window, facing up, into test strip port. 3. While the blood drop symbol flashing, press and hold the main button for over 3 seconds until the " " symbol appears. 5 OPEN 4.
Performing a Quality Control Test Maintenance Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying case if you do not use it. If meter is dropped or damaged, perform a Quality Control Test before doing a blood glucose test. Cleaning Meter Clean the outside of the meter with a damp cloth and mild soap/detergent. Protect the test strip port from getting wet. Please always keep the two metal contact points of the test strip port clean.
Recalling Test Result and Average Recalling Test Result and Average 14-days average for example; if your current inquiry time is 2008/1/30, then that you must check that you have tested blood glucose in the past 14 days before 1/30, including today. If not, the 14-day average will show no figure. - The Non-averaging/re-averaging function only works in the test mode and when you get the value. In the MEM mode, you can not perform this action. 3.
Error messages and Trouble shooting Er1 - The inserted test strip has been used or damaged. Please use a new test strip from vial. Er2 - Meter has malfunctioned. Do the Quality Control Test or reinstall the batteries to check if the meter works properly. Error messages and Trouble shooting Battery Error " symbol is blinking when the battery power is low. Please change the 1. The " meter battery as soon as you can. You can still do the test. 2.
Error messages and Trouble shooting Error messages and Trouble shooting Temperature Error In order to get accurate test result, perform testing between 10~40℃ ( 50~104℉ ). 1. When the ambient temperature is 0~9℃ ( 32~48℉) or 41~50℃ (106~122℉) the " " warning symbol will be blinking (1a), you still can do the test but the test result is only for reference, because the test result under these ranges of temperature might not be correct. In the memory screen this value will be flagged " symbol (1b).
Specification Specification Measurement Technology Oxidase Electrochemical Sensor Measurement Calibration Plasma Sample Capillary whole blood Minimum Sample Volume 1.0 microliters Measuring Range 10-600 mg/dL ( 0.6-33.3 mmol/L ) Test Time 5 seconds Memory Capacity Hematocrit 30-60% Power Supply 2 CR2032 batteries Meter Battery Life About 1000 tests Meter Dimension 90.6 mm x 46 mm x 16.5 mm Meter Weight 53.
Limitations TM - Rightest GM550 BGMS is not intended for serum or plasma test. - Inaccurate test results may be obtained at high altitude more than about 3048 meters (10,000 feet) above sea level. - Severe dehydration and excessive water loss may cause inaccurately low results. TM - Rightest GM550 BGMS has not been validated for use on neonates. - The glucose test may be interfered under abnormal concentration of Uric acid >16 mg/dL ( >0.
Customer Service Accuracy Table 2: represents samples for glucose results greater than 75 mg/dL. Difference range in values between the Olympus value and the Rightest™ meter value The percent ( and number ) of samples for which the difference between the Rightest™ meter value and the Olympus value were within the difference range shown in the side row. Fingertip Palm Forearm Within ± 5% 55.8% (53/95) 55.8% (53/95) 49.5% (47/95) Within ± 10% 75.8% (72/95) 75.8% (72/95) 71.
Warranty The manufacturer warrants that your RightestTM GM550 Meter will be free from defects in materials and workmanship for five years from the date of purchase. TM This warranty does not apply to the performance of a Rightest GM550 Meter that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the meter. Please complete and return the enclosed warranty card to your local Bionime affiliate.
