Swiscare Technology GM20NBLE Ecare IA Blood Glucose Monitoring System User Manual

Swiscare Technology Co., Ltd. Ecare IA Blood Glucose Monitoring System

Contents

User Manual

Intended for useEcare IAThe Blood Glucose Monitoring Systems is intended for the quantitative measurement of glucose in fresh venous whole blood, or in fresh capillary whole blood from the fingertip. It is intended people with diabetes mellitus at home or healthcare facilities for monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.Test PrincipleThe blood glucose monitoring system is plasma calibrated Ecare IAto allow easy comparison of results with laboratory methods. Glucose in the blood sample mixes with special chemicals on the test strip and a small electrical current is produced. This current is measured by the Meter and displayed as your blood glucose result. The strength Ecare IA of these currents changes with the amount of glucose in the blood sample.Ecare IA Blood Glucose Test stripNote1. Meter should only be used with Blood Glucose Test Strip. Using Ecare IA Ecare IA other test strips with this meter can produce inaccurate results.2.The front side of the Blood Glucose Test Strip should face up when inserting Ecare IA the Blood Glucose Test Strip.Ecare IA3.The strips are for single use only, please do not reuse or use the used strip and repeat the test.Please insert the test strip The temperature is out of rangePlease apply blood to the strip Control solution mode Measurement Unit Milligram per Deciliter Millimole per Liter1. Ecare IA Meter × 1 .Lancet device × 1 3. Ecare IA Blood Glucose Test Strip vial × 14. Lancet × 10 5.Ecare GDH Control Material 6.AAA Alkaline Battery (Optional)Protective coverLancet pointOperation of Lancing device• Alternative site testing means that people test blood glucose from the forearm, upper arm or finger tip.• Please consult your doctor to determine if alternative site testing is right for you.Select a soft, fleshy area of skin that is free from hair, moles and visible • veins for alternative site testing.Avoid lancing areas with obvious veins or moles to avoid excess bleeding • or where tendons or bones stick out (for example, hand bones and ankle bones)AST alternate site testingIt is strongly recommend that do AST ONLY in the following intervals-In a pre-meal or fasting state (more than 2 hours since the last meal).-Two hours or more after taking insulin.-Two hours or more after exercise.Do Not do AST-You think your blood glucose is low.-You are unaware of hypoglycemia.-Your AST results do not match how you feel.-You are testing for hyperglycemia.-Your routine glucose results are often fluctuating.-If you are pregnant. Run a control test by Ecare GDH Control Material (optional accessory) when you open a new vial of test strips or if you think that your test result is incorrect. Running a control test lets you know that the meter and test strips are working properly.IA Blood GlucoseMonitoring SystemUser’s Manual2 AAA 1.Press S button 2 seconds into the setting mode. (no test strip inserted). Please follow the below steps to change the parameters.2.The “L-1” on the display. Press "M" to select the languages(L-1~L-3) ,then press "S" to confirm language:3.The “3” on the display. Press "M" to select the volume(3~0) , then press "S" to confirm volume: 3:high volume 0:mute1.The year flashes on the display. Press "M" to select the year(2015~2050) ,then press "S" to confirm year.2.Repeat the same steps to set the month, date ,hour and minute.NoteThe hour format is the 12-hour time.MemorysymbolControlSolutionModeSet the measurement unit 1.The measurement unit flashes.2.Set the measurement unit: Press "M"to select the unit :mg/dL or mmol/L.3.Press "S" to confirm measurement unit. Note 1. The unit can be changed in setting mode. 2. If you can not change unit during step 2, it means the system was fixed the unit by default setting. 1. Wash hands with soap and warm water. Rinse and dry thoroughly.2. Pull out a test strip from the box and must re-cap the box immediately.3. Insert the test strip, the front side of the test strip face up, into the test port. The meter will automatically turn on. 1. The “dEL” display, press “S” goes to sleep mode. 2. Or press “M” 2 sec, it displays “OK” to delete all memory, then goes to sleep mode. Delete the test resultPreparing your blood sample1. Wash your hands with soap and warm water. Then rinse and dry thoroughly.2. Massage the puncture site.3. Using lancet device firmly on the side of the fingertip to get a drop of blood.4. Press the button on the lancet device. The blood has been taking as you hear a click sound.5. Gently squeeze or massage your finger until drop of blood forms.Note• The user must wash hands thoroughly with soap and water after handling the meter, lancet device or test strips.• The lancets can not to be re-used or used more than one person to increase the infection risk.• Don’t use Povidone Iodine Solution or any org nic solvent for cleaning!• Wait until hands dry completely! Note1. Please do not touch on the strip by your finger or use the smearing blood sample.2. Do not remove the strip before complete 6 seconds count down, or it will be automatically shut down. 3. The test strips cannot be re-used.Blood glucos e 120 mg/dL.Now Te sting.Contr ol Solut ion M ode.Please apply blood into the te st strip.1. Inserting the test strip.3. Put your blood drop to the Reaction Area on the strip.4. After dropping the blood , you will hear a beep sound, then it starts 6 seconds count down at the same time.5. The result will appear on the display, auto-saving in memory.6.Remove the used test strip, then it goes to sleep mode.2. Press “M” button to highlight your status as “control mode ”, “before meals ”, “after meals ” or in general mode without labeling.a) Pressing once “M” button highlights the value with as control solution mode. (Testing results in control solution mode will not store in memory.)b) Pressing once “M” button highlights the value with as before meals status.c) Pressing once “M” button highlights the value with as after meals status.d) Pressing one more “M” button removes the highlight with general mode.LCD Display36.4 44.4xInsert test strip hereBattery coverLabelFor Model : GM20
1. Connect to the PC by USB cable.2. Please follow the procedures described in “Ecare BGMs Data Transfer Software”. 1 .Place the lancet cover on a hard surface. Push the lancet point into the cover.2. Place the lancet cover back on the exposed lancet point.3. Discard the used lancet and test strip. ‧Never immerse the meter or lancet device in water, and do not get any moisture in the test strip slot.Do not get wet at the computer port.‧Make sure the meter is off.‧1. Wipe the meter or lancet device by following recommended material: CaviWipes™‧ (EPA* reg. no. 46781-8)2. Wipe the meter dry with a soft cloth .or gauze‧Please store the system in a safe and dry location.Avoid long-term sun exposure.‧Avoid the meter to strong shocks, such as dropping the unit on the floor.‧If the meter will not be used every day, please remove the battery.‧The test of control solution is out of the range.Customer service line:+1-949-702-0769, 24 hours a day, 365 days a year.Swiscare Technology Co., Ltd.2F., No.43,45, Lan e3, Sec.1,Zhongzheng E. Rd.,Tamsui Dist.,New Taipei City 251, Taiwan (R.O.C.) : +886-2-2629-0878TEL+886-2-2629-0118FAX：service@swiscare.comE-mail：Date transferring starts connection and will upload successfullyautomatically.THE SYMBOLRev. 20151013P/N:8-3003002 If you want to transfer your blood glucose testing data to computer(PC), please transfer your data by using "Ecare BGMs Data Transfer Software". Your blood glucose data shall be automatic transfered successfully by performing following steps: 1. Connect one end of the USB Cable to the USB port of your meter. 2. Connect the other end of the USB Cable to the USB port of your personal computer(PC).Situation ActionSituation ActionPlease insert the test strip.1.When "1" appears on the display, the value of the first result will appear later automatically.2."1"means the most recent result with the result appears on the display .3.Press the "M" button continually to review the results until last one.4.Press the "M" button once, than it will be into the sleep mode and turned off automatically.5.If you do not review memory during step 1~4,press "S"button to turn off the meter.Name Ecare IA Blood GlucoseMonitoring SystemBettery 2 × AAA AlkalineBettery Life Approximately 1,000 testsDimension & Weight 97 × 54 × 20 mm &83 g( with battery )Measurement Range 20 mg/dl ~ 600 mg/dl(1.1mmol/l ~ 33.3mmol/l)Operation Temperature 10～40°C (50～104 °F)Operation Humidity 10～90 %Storage CircumstanceMeter：-20～70°C (-4～158 °F)Strip：6～42°C (42.8～107.6F)RH:10～90%Response Time 6 secondsAverage 7/14/28 days average resultsHematocrit 20%～60 %Sample Volume 1.0ulTest Sample Capillary or Venous whole bloodUpload successfulNote Do not use vinegar or scouring agents to clean meter because they can harm the display and measurement window.* Environmental Protection Agency. 3. CaviWipes can be purchased from the following sources:TM Amazon.com‧ Officedepot.com‧ Walmart.com‧Damaged or used strips.Insufficient bloodvolume.Please prep are sufficientblood v olume and testagain by new str ip.Blood glucose testing is higher then 600 mg/dl(33.3mmol/L)Blood glucose testing is lower then 20 mg/dl(1.1mmol/L)High blood glucose level,possibly ketones. The “Ketone” flashes 5 secon ds and displayed on screen.1. Run a control solution test and restart the test.2. If the result of contro l solution test is in normal range , please t est again.Please operate the meterin the appropriate te mperature: 10-40°C(50-104°F)Please operate the meterin the appropriate te mperature: 10-40°C(50-104°F)Cha nge the battery.Try again. If the same is sue occurs, please ask for help for the local distributors.Damaged or used str ip, ple ase discard it and testagain.Please contact your lo cal distribu tor. Operating temperatu reis above 40°C.Operating temperatureis below 10°C.Low battery.USB disconnection wh en remove the meter or the USB cable during the transfer.Met er internal self-checking error.MaintenanceWarning message The meter can store up to 300 test results.Enter the memory mode1.Press "M"2 seconds with the meter off to enter the memory mode.Note1.No result appears when first time using the new Ecare Meter. And appears three dashes on the display. 2.You will not be able to perform a blood glucose test in this mode.2.The first result appears on the display is the 7 days average of the test results, and numbers of the result in 7 days displayed on upper right side.3.Press"M" continuously, the consecutive 14/28-days average results will be shown on display in order.NoteThe consecutive 7/14/28-day average is calculated from the blood glucose results obtained during the last consecutive 7/14/28-day. The expiration time of a strip vial is (YYYY-MM).‧ Once you open it , the expired time is 90 days.‧ It is recommended to write the date when you open the strip vial.‧ Please do not use the strip past the expired date which may lead to the ‧ wrong result . A drying agent is included in the strip vial.‧ Please keep the strips and the vial away from the children, prevent them ‧ from eating. Storage Circumstance:‧ Meter -20 70°C (-4 158 °F) RH:10 90： ～ ～ ～ % Strip 6 42°C (42.8 107.6 °F)： ～ ～ Keep away from moisture and sunlight. ‧ Please store the strip vial in a safe and dry location, and avoid long-term ‧ sun exposure. Do not store the strips outside the vial.‧ Do not store the strip in the other vial.‧ Please do not touch the strip by a wet hand.‧ Once you take the strip from the vial, please use it as soon as possible. ‧ And re-cap the vial immediately. Please do not bend or cut the strip.‧Storage of stripsGuidance for conditionRemoving the used lancetIf you would like to review the results from the computer, please contact the sales distributor for assistance.Situation ActionEquilibrate the control material at room temperature for 30 minutes.Consult operating instructionsCaution need consult the instruction for useYour test strips' lot numberSerial numberUse-by dateFor in vitro diagnostic useControl MaterialDo not reuseTemperature LimitationEU Authorized RepresentativeManufacturerCONTROLDispose of used test strip as well as lancets carefully to prevent injury or contamination. Please dispose of in accordance with your local ordinancesFor environmental reasons, do not dispose of the devicewith the household waste at the end of its service life.If you have any questions, please contact the local authorities responsible for waste disposal.FCC Marking:This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditio ns: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.NOTE: This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:Reorient or relocate the receiving antenna.—Increase the separation between the equipment and receiver.—Connect the equipment into an outlet on a circuit different from that to —which the receiver is connected.Consult the dealer or an experienced radio/TV technician for help.—LancetManfactured by: Shandong Lianfa Medical Plastic Products Co.,Ltd No.1 Shuangshan Sanjian Road 250200 Zhangqiu City,Jinan, Shandong PEOPLE’S REPUBLIC CHINA

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