Handleiding Rossmax HS200 Bloedglucosemeter

Handleiding

1. The time period for glucose results average

2. Meal ag (no meal / pre-meal / post-meal ).

3. The number used for time period based glucose results average.

4. The average glucose result calculated based on time period (upper left),

number of results (upper right) and meal ag (lower left).

5. The average glucose result calculated from all 14 day test results.

Note:

1. The consecutive 7/14/30 time period based glucose results average is

calculated from the test results obtained during the last consecutive

7/14/30 day periods.

Manufacturer of Blood Glucose Meter, Test Strip and Control Solution

Tyson Bioresearch, Inc.

5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan

Medical Device Safety Service GmbH Schiffgraben 41, D-30175 Hannover, Germany

Manufacturer of Lancet and Lancing Device

Shandong Lianfa Medical Plastic Products Co., Ltd.

No.1 Shuangshan Sanjian Road 250200 Zhangqiu City, Jinan, Shandong PEOPLE’S REPUBLIC OF CHINA

Shanghai International Holding Corp. GmbH (Europe) Eiestraße 80, 20537 Hamburg, GERMANY

MEDIFUN CORPORATION (Lancing Device Only)

No.8, Shuyi Rd., South Dist., Taichung City, 40241, Taiwan (R.O.C.)

MDSS GmbH Schiffgroben 41,30175 Hannover, Germany

Other problems which may occur Action

A test strip has not been inserted into the meter

properly.

Review the instructions and re-insert a test strip

correctly.

Defective test strip. Replace with a new test strip.

A test strip remains in the test port for more than 2

minutes before testing.

Review the instructions and re-insert a test strip

correctly.

LCD display on the meter is blank when trying to

perform a test.

Please return the device to your local distributor or

service center.

The meter does not function after new batteries are

installed.

Please remove batteries and wait for 1 minute, reinstall

batteries to see if meter is working properly.

Authorised Representative in the European Community Manufacturer

Do not use if package is damaged In vitro diagnostic medical device

Temperature limitation Consult instructions for use

Batch code Sucient for

Use by Catalogue number

Keep dry Keep away from sunlight

Do not reuse Control

Serial Number Caution

Trouble Shooting

Explanations of Symbols

Operation Temperature 10°C ~ 40°C (50°F ~ 104°F)

Operation Humidity 10 ~ 90% RH

Hematocrit 0 ~ 70%

Test Sample Venous and Capillary Whole Blood (ngertip, palm, forearm)

Sample Volume 0.7 µL

Measuring Unit mg/dL or mmol/L

Measuring Range 20 ~ 600 mg/dL (1.1 ~ 33.3 mmol/L)

Test Time 5 seconds countdown

Memory Capacity 500 most recent results

External Output Micro USB Interface

Average 7/14/30 days average

Power supply 2 AAA batteries

Battery Life Approximately 1000 tests

Dimension 108L x 55W x 17H mm

Weight 52 g without batteries

Note: Please refer to the Test Strip Insert for the performance of system accuracy and precision.

Electromagnetic Compatibility

This Meter meets the electromagnetic compatibility requirements as per EN 61326-1 and EN 61326-2-6.

Caution: Strong electromagnetic elds may interfere with the proper operation of the meter. Do not use the

meter close to sources of strong electromagnetic radiation.

Interference substance Highest tested concentration with no signicant interference

Acetaminophen 4.25 mg/dL

Ascorbate(Ascorbic acid) 3 mg/dL

Bilirubin 25 mg/dL

Cholesterol 1200 mg/dL

Creatinine 10 mg/dL

Dopamine 2 mg/dL

EDTA 200 mg/dL

Galactose 500 mg/dL

Gentisic acid 2.5 mg/dL

Glutathione 3.07 mg/dL

Haemoglobin-HUMAN 3000 mg/dL

Heparin 5 IU/ml

Hydrogenated starch hydrolysates (HSH) 0.09 mg/dL

Ibuprofen 50 mg/dL

Icodextrin 750 mg/dL

Isomalt 0.09 mg/dL

Lactitol 0.09 mg/dL

L -DOPA(L-3-4 dihydroxyphenylalanine) 0.5 mg/dL

Maltose 2575 mg/dL

Maltitol 0.09 mg/dL

Mannitol 0.09 mg/dL

Methyldopa 2.5 mg/dL

Pralidoxime iodide (PAM) 5 mg/dL

Salicylate 50 mg/dL

Sodium Carbonate 37.5 mEq/L

Sorbitol 0.09 mg/dL

Tolbutamide 100 mg/dL

Tolazamide 6 mg/dL

Triglycerides 1525 mg/dL

Uric acid 8 mg/dL

Xylose 5 mg/dL

Xylitol 0.09 mg/dL

Warning Xylose

Xylose would result in the overestimation of blood glucose reading if the blood sample containing xylose with the concentration over 5 mg/

dL. Do not use this system during or shortly after receiving xylose absorption therapy since xylose may case inaccurate blood glucose results.

Specications

Tolerance summary of interference substance

• Transport and store at temperature -20°C ~ 50°C ( -4°F ~ 122 °F), Less than 90% RH

• Precision instrument, do not crash when being transported.

Caution:

• Rossmax HS200 Blood Glucose Monitoring System is designed for in vitro diagnostic use only and is not intended

to test on neonate.

• Any change or administer of medication based on the Rossmax HS200 blood glucose test results without the con-

sent advice of a physician or healthcare professional is not recommended.

• The Rossmax HS200 Blood Glucose Test Strip are designed for use with fresh venous whole blood or capillary whole

blood samples obtained from the ngertip, palm and forearm. DO NOT use samples other than venous whole

blood or capillary whole blood.

• False results may occur when performing the test while severely dehydrated, severely hypotensive, in shock or in

a hyperglycemic-hyperosmolar state. If you believe you are suering from any of the above symptoms, consult a

healthcare professional immediately.

• Please refer to Rossmax HS200 Blood Glucose Test Strip Package Insert to access further information on strip Limi-

tations.

IMPORTANT

• The Rossmax HS200 Blood Glucose Meter, Rossmax HS200 Blood Glucose Test Strip and Control Solution are in

conformity with the IVDD 98/79/EC.

• Rossmax HS200 Blood Glucose Monitoring System manufacturer warranty is valid only when used properly within

the guidelines of this User Manual provided.

• The Lancing device and Lancets are in conformity with the MDD 93/42/EEC.

Manufacturer Warranty

This instrument is covered by a 3 year guarantee from the date of purchase, batteries and accessories are not in-

cluded. The guarantee is valid only on presentation of the guarantee card completed by the dealer confirming date

of purchase or the receipt. Opening or altering the instrument invalidates the guarantee. The guarantee does not

cover damage, accidents or non-compliance with the instruction manual. Please contact your local seller/dealer or

www.rossmax.com.

Customer Name: ___________________________________________________________________________

Address: __________________________________________________________________________________

Telephone: ________________________________________________________________________________

E-mail address: _____________________________________________________________________________

Product Information:

Date of purchase: ___________________________________________________________________________

Store where purchased:

__________________________________________________________________________________________

Meter Storage

Limitations of the Procedure

Service and Warranty

Display Description Action

appears when the result

is HIGHER than the “HI” alert

setting.

The default setting is 180mg/dL or 9.5mmol/L and it can be changed

according to «Setting Up the HI/LO Alarms»

appears when the result

is LOWER than the “LO” alert

setting.

The default setting is 70 mg/dL or 3.2mmol/L and it can be changed

according to «Setting Up the HI/LO Alarms»

Test result is HIGHER than 600

mg/dL (33.3 mmol/L).

Repeat the test by using a new test strip. If the same message displays

again, the result is confirmed to be higher than the meter operating

range. Please consult your healthcare professional immediately for

further advice.

Test result is LOWER than 20

mg/dL (1.1 mmol/L).

Repeat the test by using a new test strip. If the same message displays

again, the result is confirmed to be lower than the meter operating

range. Please consult your healthcare professional immediately for

further advice.

Temperature is TOO HIGH

during the test procedure.

Large variation may occur between results due to high or low

temperature. Move to an environment (10˚C ~ 40˚C or 50˚F ~ 104˚F)

and wait for 30 minutes before re-testing.

Temperature is TOO LOW

during the test procedure.

Large variation may occur between results due to high or low

temperature. Move to an environment (10˚C ~ 40˚C or 50˚F ~ 104˚F)

and wait for 30 minutes before re-testing.

The preset alarm is ringing to

remind the user that it is time

to perform a blood glucose

test.

Please press any button to turn off the alarm or wait for the alarm to be

turned off automatically in 30 seconds.

Battery power is LOW.

Meter will only provide

approximately 10 more

measurements.

Replace with 2 AAA batteries.

Display Description Action

Temperature is TOO HIGH to

perform a test.

Move to an environment (10˚C ~ 40˚C or 50˚F ~ 104˚F) and wait

for 30 minutes before re-testing.

Temperature is TOO LOW to

perform a test.

Move to an environment (10˚C ~ 40˚C or 50˚F ~ 104˚F) and wait

for 30 minutes before re-testing.

Battery power is depleted for any

further usage.

Replace with 2 AAA batteries immediately.

This message is displayed when

your meter has NOT been coded.

Please return the device to your local distributor or service center.

An error message indicates a

problem with the test strip.

Please review the instructions and try again with a new test strip.

If the problem persists, please return the device to your local

distributor or service center.

An error message indicates a

problem with the test strip or

meter.

Please review the instructions and try again with a new test strip.

If the problem persists, please return the device to your local

distributor or service center.

An error message indicates a

problem with the meter.

Please remove batteries and wait for 1 minute, reinstall batteries

to see if meter is working properly. If the problem persists, please

return the device to your local distributor or service center.

An error message indicates a

problem with the test strip.

Please review the instructions and try again with a new test strip.

If the problem persists, please return the device to your local

distributor or service center.

An error message indicates a

problem with the meter.

Please remove batteries and wait for 1 minute, reinstall batteries

to see if meter is working properly. If the problem persists, please

return the device to your local distributor or service center.

An error message indicates a

problem with the test strip.

Please review the instructions and try again with a new test strip.

If the problem persists, please return the device to your local

distributor or service center.

An error message indicates

insucient volume of blood

sample for the test.

Review the instructions and try again with a new test strip, then

applying a sucient blood sample to the test strip. Please return

the device to your local distributor or service center if the problem

persists.

Display Messages

Error Messages

Initial Set-Up

Please visit the website at http://www.rossmax.com for the initial set-up instructions.

1. Download and install the applicable APP onto your mobile device.

2. Turn the meter (refer to “ Preparing Test Strip” section ), Bluetooth and the APP of mobile device on and follow set-

up and pairing instructions.

3. If the pairing is successful, once the measurement is done, the current measured reading will automatically be

transferred to the APP.

Transfer Memory data

1. Turn Bluetooth your mobile device and applicable APP on.

2. Press to turn on the meter (Fig. 49).

3. When the meter is switched ON, hold for 4 seconds to enter Bluetooth mode. will appear and ash on the

meter if the meter is not never paring with a mobile device. (Fig. 50).

4. stops blinking when the meter & mobile device is connected.

5. Press the button on APP to transfer data. The meter will display while data are being transferred (Fig. 51).

You can use PC Link to transfer test results to your personal computer. Obtain the required

software and micro USB cable to be ordered separately. Please visit the website at http://www.

rossmax.com for proceeding the downloading and installation process.

1. Follow the instructions provided with software to install the software into your personal

computer.

2. Connect the interface cable to a USB port on your computer while the meter is o.

3. Connect the other end of interface cable to the data port located on the side of the meter.

4. The word "PC" will appear on the display indicates that the meter is now in the communication

mode (Fig. 52).

General Cleaning

• Switch the meter OFF.

• Use a soft cloth moistened with water or a mild detergent, gently wipe the meter surface.

• Please avoid using alcohol or organic solvents in cleaning.

• Do not immerse the meter in water when cleaning. Do not allow water or cleaning uids into the meter, test port,

and data port.

Professional Disinfection

Applicable for people who use the blood glucose meter

• Cleaning solution and disinfecting solution: Clorox Bleach Germicidal Wipes ( Clorox Professional Products Company.

EPA Reg. No. 67619-12). Contact Clorox Company at 1-800-537-1415.

• Personal Protection: Sanitize hands, and then put on gloves before removing a germicidal wipe from the canister.

When handling items soiled with blood or body uids, use disposable latex gloves, gowns, masks and eye coverings.

• Meter: turn it o

• Wipe: Clorox Bleach Germicidal Wipes by thoroughly wetting the exterior of the meter, allow the surface to stay wet

for 1 minute then allow to air dry.

• Disposal of Infectious Materials: Use disposable gloves. Never reuse or re-wet a disposable wipe. Dispose of according

to local regulations for infectious waste disposal.

• Please refer to the Clorox Bleach Germicidal Wipes detailed usage instructions.

Please handle the meter with care. Dropping the meter may result in damage.

1. Do not expose the meter, test strips, and the Control Solution to extreme conditions such as high humidity, heat,

freezing cold, or dust.

2. The meter should be stored at room temperature in a dry and clean area. DO NOT STORE IN DIRECT SUNLIGHT OR

AREAS WITH HIGH HUMIDITY AND/OR DUST.

It is advised that you store all parts of Rossmax HS200 Blood Glucose Monitoring System in the carrying bag

provided.

How to view results stored in the memory

1. When the meter is o, press button to turn on the

meter. The Data and Time will be shown on (At the left-

upper corner. Firstly the year is shown for 1 second, and

then Month-Day will be shown on in the same area.)

2. Press to view previous results. “MEM” icon will be dis-

played on the top center area. Initially, the “year” will be

display on the top left corner (Fig.43). After 1 second

“month-day” will then be displayed on the top left cor-

ner and “time” will be displayed on the top right corner

(Fig. 44). The most recent memory results will be dis-

played rst.

3. You can press or to scroll forwards and backwards

through the results.

4. Press button to exit the stored test results or the meter will be shut o automatically after 2 minutes without

any action.

How to view the control solution test result in the memory

1. When the meter is o, press button to turn on the meter.

2. Press button again, and the latest control solution test result will be displayed (Fig. 45).

3. Press button to turn o the meter or the meter will be shut o automatically after 2 minutes without any action.

Note:

1. A result with or symbol indicates that the reading was taken out of the meter’s specied operation

temperature range and may not be accurate. This value is excluded from the 7/14/30 time period based

glucose results average.

View Time Periods Based Average Glucose Results

1. Press to turn the meter on, then Press button to view time periods based average glucose results.

2. 7/14/30 time periods based average glucose results marked with a no meal / pre-meal / post-meal and will

be displayed on screen in sequence when is pressed (Fig. 46 ~ 48 ).

3. When the meter displays 7 days with no meal status assigned, press button and the meter will then change to

view stored test results in memory.

4. Press button to turn o the meter or the meter will be shut o automatically after 2 minutes without any action.

Bluetooth Data Transfer (optional)

PC Data Transfer (optional)

Cleaning and Disinfection Procedure

Care and Storage

Recalling Values from Memory

(Fig. 49) (Fig. 50) (Fig. 51)

(Fig. 52)

(Fig. 44) (Fig. 45)(Fig. 43)

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

(Fig. 47) (Fig. 48)

All results

Results marked with (pre-meal)

Results marked with (post-meal)

(Fig. 46)

An error message indicates a

problem with the meter.

Please remove batteries and wait for 1 minute, reinstall batteries

to see if meter is working properly. If the problem persists, please

return the device to your local distributor or service center.

 Rossmax Swiss GmbH, 9435 Heerbrugg, Switzerland, www.rossmax.com

Model: HS200

www.rossmax.com

Blood Glucose Monitoring System

Instruction Manual

IN5HS20000000XXXX

RM_IB_HS200_

EN_ver2122

Beoordeling

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