EvenCare G2 Bedienungsanleitung

BLOOD GLUCOSE MONITORING SYSTEM

Healthcare Professional Operator’s Manual

Operator’s Manual & In-Service Guide

BLOOD GLUCOSE MONITORING SYSTEM

Healthcare Professional Operator’s Manual

Operator’s Manual & In-Service Guide

TABLE OF CONTENTS

OPERATOR’S MANUAL

INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

METER OVERVIEW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

METER DISPLAY SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

SYSTEM SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

EVENCARE G2 CONTROL SOLUTION TESTING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7–8

BLOOD GLUCOSE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

UNDERSTANDING TEST RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

USING THE METER MEMORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

CLEANING AND DISINFECTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12–13

CHANGING THE BATTERIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

STORAGE AND PRECAUTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15–16

IN-SERVICE GUIDE

IN-SERVICE TRAINING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

OPERATOR CERTIFICATION CHECKLIST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

SELF TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

SELF TEST ANSWER KEY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

EVENCARE G2 BLOOD GLUCOSE MONITORING SYSTEM:

NURSE IN-SERVICE TRAINING RECORD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

BLOOD GLUCOSE MONITORING SYSTEM:

CERTIFIED INSTRUCTOR RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

BLOOD GLUCOSE MONITORING SYSTEM:

CERTIFIED INSTRUCTOR RECORD COMPETENCY CHECKLIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

BLOOD GLUCOSE MONITORING SYSTEM:

REVIEW OF NURSE’S TECHNIQUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

EVENCARE G2 QUALITY CONTROL LOG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

BLOOD GLUCOSE SYSTEM PERFORMING A CONTROL SOLUTION TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

GLUCOSE TEST STRIP PACKAGE INSERT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

GLUCOSE CONTROL SOLUTION PACKAGE INSERT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

BLOOD GLUCOSE MONITORING SYSTEM HEALTHCARE

PROFESSIONAL OPERATOR’S MANUAL & IN-SERVICE GUIDE

Thank you for choosing the EVENCARE G2 Blood Glucose Monitoring

System to help monitor your patient’s blood glucose levels.

The EVENCARE G2 Blood Glucose Monitoring System is designed

to be accurate and easy to use. The EVENCARE G2 Blood Glucose

Monitoring System is intended

for both lay use by people with

diabetes and in a clinical setting

by healthcare professionals,

as an aid to monitoring levels

in Diabetes Mellitus.

If you need assistance, please call

Medline’s Technical Service Center

at 1-866-274-2131 Monday through

Friday between 8:00 am and

5:00 pm (Central Time).

OPERATOR’S

MANUAL

OPERATOR'S MANUAL

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Low

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G2 METER OVERVIEW

ENTER ( ) and ▲▼BUTTONS

Press and hold Enter ( ) for 2 seconds

to turn on or off the meter. Press Enter ( )

to go into setup mode when not testing

Press ▲or▼to enter control mode with test

strip inserted, during meter setting, or to

navigate the stored test values and averages

METER DISPLAY

Shows your blood glucose test results,

memory values, averages, and other messages.

TEST STRIP PORT

Insert test strip to turn on the meter.

BATTERY COMPARTMENT

Holds two AAA batteries.

DATA PORT

This function is not yet available.

EVENCARE G2

METER FRONT

EVENCARE G2

METER BACK

OPERATOR'S MANUAL

mg /dL

DAY

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mg /dL

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mol/dL

code

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code

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codecode

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PM PM PM PM PM

MEM

Indicates the number in

the meter display is a

stored test value.

ALARM

Indicates alarm has

been set.

CABLE

Indicates the meter is in

data transfer mode to PC.*

*This function is not available yet.

END

Will appear on the display

screen after the last

recorded test result, if less

then 300 readings are stored.

Displays the date, time, AM/PM, or

type of day averages (7, 14 or 30).

CTL

This icon indicates a

control solution test

or the stored value is a

control solution result.

TEMPERATURE

Appears when it is either too

hot or too cold to test (outside

the ranges of 50˚F–104˚F).

BEEPER

Set sound volume

CLOCK

Indicates the meter is ready to

set up time and date.

VOICE

Indicates the voice

feature is on.

UNITS

Unit of measurement for

your blood glucose is mg/dL.

BLOOD DROP and ARROW

Indicates the meter is ready

for testing.

BATTERY

Appears when batteries

need to be changed.

SYSTEM SPECIFICATIONS

Test Strips: EVENCARE G2 Blood Glucose Test Strips

Test Range: 20–600 mg/dL

Calibration: Plasma

Test Time: 6 Seconds

Sample Size: Larger than 1uL

Hematocrit Range: 30–55%

Display Type: Large LCD screen

Memory: 300 blood test results with date and time

Result Averaging: 7, 14 and 30 days averaging

Dimensions: 93L x 58W x 20.5H (mm)

Weight: 79g

Battery: 2 Alkaline AAA Battery

Battery Life: 1,000 tests of continuous use or 1 year

Automatic Power-off: After 2 minutes of non-use

Operating Temperature: 50˚F–104˚F

Relative Humidity: Less than 85%

Storage Condition: Meter at 39˚F–122˚F, Test Strips at 39˚F–86˚F

OPERATOR'S MANUAL

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PM PM PM PM PM

EVENCARE G2 CONTROL SOLUTION TESTING

The purpose of the control solution testing is to make sure the EVENCARE G2 Meter and the EVENCARE G2

Test Strips are working properly.

You should perform a control solution test when:

»Using the meter for the first time.

»Using a new bottle of EVENCARE G2 Blood Glucose Test Strips.

»You left the test strip bottle cap open for awhile.

»You dropped the meter.

»You suspect your meter and test strips are not working properly.

»The blood glucose test results do not reflect how you feel.

»You want to practice the testing procedure.

IMPORTANT

»Use only the EVENCARE G2 Glucose Control Solutions with the EVENCARE G2

Test Strips. Other brands of control solution will produce inaccurate results.

»Always check the expiration date. DO NOT use control solutions if they are expired.

»DO NOT FREEZE. Store the control solutions at room temperature.

MATERIALS NEEDED:

»EVENCARE G2 Control Solution (Low and High)

»Your EVENCARE G2 Meter

»A new EVENCARE G2 Blood Glucose Test Strip

Step 1. Take out an EVENCARE G2 Test Strip from the test strip bottle and

close the bottle immediately. Insert the test strip to turn on the meter.

IMPORTANT

»Check the expiration date printed on the test strip bottle.

»Do not use expired test strips.

»Use each test strip immediately after removing it from the bottle.

»Do not use wet or damaged test strips.

»Keep test strips away from direct sunlight and heat.

»Store the test strip bottle in a dry, cool place.

»Record the “date opened” on the bottle label. Discard the bottle and

any remaining test strip after 6 months from date of opening.

»Test within the temperature range of 50˚F to 104˚F. Your meter will not work

Insert the test strip properly.

»The flashing blood drop icon will appear once the test strip has been fully inserted.

Step 2. Wait until the flashing blood drop and arrow icons appear on the meter display

screen. The meter will also announce, “Please apply blood onto the test strip” if you

have the voice feature turned on. Press ▼one time to enter L1 (LOW) control solution

testing.

Step 3. ctl icon will appear next to the test strip icon and L1 will appear on the

meter display screen. The meter will also announce “L1 control solution test,

please apply control solution onto the test strip.” If you decide not to do a control

solution test, press ▼two times and ctl will disappear from the meter display.

Step 4. Squeeze a drop of Low control solution onto a clean, dry, non-absorbent surface. Do not apply control solution to the

test strip directly from the control solution bottle. Replace the bottle cap on the control solution bottle immediately after use.

OPERATOR'S MANUAL

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53~79

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Low

High

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53~79

135~203

Low

High

Sampling End

EVENCARE® G2™

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DO NOT touch the sampling end of the test strip with the bottle of control solution.

See illustration of sampling end below.

Step 5. Gently touch the tip of the test strip to the drop of control solution.

The meter will beep indicating it has received the control solution. The

screen will start to count down. After 6 seconds, the control solution test

result will appear on the meter display screen.

Step 6. Compare the reading on the screen to the Low range printed on the test strip bottle.

If the reading falls outside the Low range printed on the test strip bottle, see Control Solution

Troubleshooting section in User’s Guide.

NOTE:

»Control solution test results will be stored in meter memory and indicated by ctl icon.

»Control solution test results will not be used for calculating averages.

Step 7. Remove the used test strip. The meter will automatically turn off. Discard the used test strip.

Follow steps 8 through 14 to perform the High control solution testing.

IMPORTANT

Do not reuse test strips.

Step 8. Take out an EVENCARE G2 Test Strip from the test strip bottle and close

the bottle immediately. Insert the test strip to turn on the meter.

Step 9. Wait until the flashing blood drop and arrow icons appear on the meter display screen. The meter will also

announce, “Please apply blood onto the test strip” if you have the voice feature turned on. Press ▼ two times to

enter L2 (HIGH) control solution testing.

Step 10. ctl icon will appear next to the test strip icon and L2 will appear on the meter display

screen. The meter will also announce “L2 control solution test, please apply control solution

onto the test strip.” If you decide not to do a control solution test, press ▼one time and ctl

will disappear from the meter display.

Step 11. Squeeze a drop of High control solution onto a clean, dry, non-absorbent surface.

Do not apply control solution to the test strip directly from the control solution bottle.

Replace the bottle cap on the control solution bottle immediately.

Step 12. Gently touch the tip of the test strip to the drop of control solution.

The meter will beep indicating it has received the control solution.

The screen will start to count down. After 6 seconds, the control solution

test result will appear on the meter display screen.

Step 13. Compare the reading on the screen to the

High range printed on the test strip bottle. If the

reading falls outside the High range printed on the test strip bottle, see Control Solution

Troubleshooting in the User’s Guide.

Step 14. Remove the used test strip. The meter will automatically turn off.

Discard the used strip.

OPERATOR'S MANUAL

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PM PM PM PM PM

BLOOD GLUCOSE TESTING

MATERIALS NEEDED:

»EVENCARE G2 Meter

»A new EVENCARE G2 Blood Glucose Test Strip

»Auto-disabling single use lancing device—use an auto-disabling single use lancing device to take the

blood sample. Follow the manufacturer’s instructions for how the lancing device should be used.

IMPORTANT

Users need to adhere to standard precautions when handling or using this device. All parts of the glucose

monitoring system should be considered potentially infectious and are capable of transmitting blood-borne

pathogens between patients and healthcare professionals. A new pair of clean gloves should be worn by the

user before testing each patient.

Step 1. Take out an EVENCARE G2 Test Strip from the test strip bottle and close the

bottle immediately. Insert the test strip to turn on the meter.

IMPORTANT

»Check the expiration date printed on the test strip bottle and its package.

Do not use expired test strips.

»Use each test strip immediately after removing it from the bottle.

»Do not use wet or damaged test strips.

»Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool place.

»Record the “date opened” on the bottle label. Discard the bottle and any remaining

test strip after 6 months from date of opening.

»The flashing blood drop icon will appear once the test strip has been fully inserted.

Step 2. Wait for a flashing blood drop and an arrow icon to appear on the meter

display screen. The meter will also announce, “Please apply blood onto the test strip”

if you have the voice feature turned on.

Step 3. Obtain blood sample.

Step 4. Gently bring the test strip and touch the drop of blood at a slight angle. The test

strip acts like a straw to pull the blood in. Keep the test strip in the blood drop until the

meter beeps to indicate the test strip has enough blood to test.

Step 5. The screen will start to count down. After 6 seconds,

the blood glucose result will appear on the meter display screen

and will be announced verbally if you have the voice feature

turned on. The test result will be automatically stored into the

meter memory.

CAUTION:

If you see “HI” or “LO” displayed, the patient’s blood glucose level may be above 600 mg/dL or

below 20 mg/dL. Test again using fingertip testing, DO NOT test on the forearm. If you still receive

the same result, call the patient’s physician or healthcare professional immediately.

Step 6. Properly discard the used test strip. The meter will automatically shut off.

IMPORTANT

Used lancets and strips are biohazardous materials and can transmit blood-borne diseases.

Dispose of them according to local government regulation to avoid injury or contamination.

OPERATOR'S MANUAL

UNDERSTANDING TEST RESULTS

Blood glucose values will vary depending on food intake, medication, health, stress, and exercise.

The ideal range for adults with and without diabetes should be1:

»70 to 100 mg/dL before meals.

»70 to 140 mg/dL after meals.

If the meter displays a result that is “HI” or “LO” or the patient gets a result that is

more than 250 mg/dL or less than 50 mg/dL, and the patient feels ill:

»Treat their diabetes according to the instruction from their doctor and/or consult their healthcare provider.

If the meter displays results that are “HI” or “LO,” or the patient gets a result that is more

than 250 mg/dL or below 50 mg/dL AND the patient DOES NOT feel ill:

»Test the meter with a control solution.

»Test the patient again using fingertip.

If the patient still gets a high or low reading, contact their healthcare professional.

NOTE:

»Inaccurate results may occur in severely hypotensive individuals or if the patient is in shock.

»Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state,

with or without ketosis.

»Critically ill patients should not be tested with blood glucose meters.

Reference: 1. American Diabetes Association. Standards of Medical Care in Diabetes—2008. Diabetes Care. 2008;31:S12–S54.

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