ANDESFIT SA B23 Users Manual

GSH R5228 Owner’s Manual

Language: English

Unit: mg/dL

Market: US

VERSION Date By

M01A1Draft 2016/11/01 Karen Yeh

from FDA Single Patient version

BMU5228BTB_5228BT-M02A4

IMPORTANT SAFETY INFORMATION

Federal Communication Commission Interference Statement

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 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.

FCC Caution: Any changes or modifications not expressly approved by the party

responsible for compliance could void the user's authority to operate this equipment.

This device complies with Part 15 of the FCC Rules. Operation is subject to the

following two conditions: (1) This device may not cause harmful interference, and (2)

this device must accept any interference received, including interference that may

cause undesired operation.

IMPORTANT NOTE:

Radiation Exposure Statement:

The product comply with the US portable RF exposure limit set forth for an

uncontrolled environment and are safe for intended operation as described in this

manual. The further RF exposure reduction can be achieved if the product can be

kept as far as possible from the user body or set the device to lower output power if

such function is available.

This transmitter must not be co-located or operating in conjunction with any other

antenna or transmitter.

 Please use this device only for the intended use described in this user guide.

 Before using this system to test your blood glucose, please read instructions

thoroughly and practice the test when you first use this system. Do a quality

check on the system by following the instructions and consult with healthcare

professionals for questions or problems.

 Be aware of the safety of young children or handicapped persons near you

when you conduct a glucose test using this system.

 Please keep the test strip vial away from children. The test strips and vial cap

can present a choking hazard.

 GSH test strips can only be used with the GSH glucose meter.

Precaution

The meter and lancing device are for single patient use. Do not share them with

anyone including other family members!

Do not use on multiple patients!

All parts of the kit are considered biohazardous and can potentially transmit

infectious diseases, even after all cleaning and disinfection procedures have

been performed.

For further information, please refer to below:

FDA Public Health Notification: Use of Fingerstick Devices on More than One

Person Poses Risk for Transmitting Bloodborne Pathogens: Initial

Communication” (2010)

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

ucm224025.htm

CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person

Poses Risk for Transmitting Bloodborne Pathogens” (2010)

http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

 Lancet

Never share a lancet with anyone. Always use a new, sterile lancet; lancets are

for single use only.

 Lancing Devices

Lancing devices should never be used for more than one person. Lancing

devices are re-useable, and the lifetime cleaning does not affect its

performance.

 Test Strips

GSH Glucose test strips are intended for single use only. They should be

disposed of in an appropriate container according to your healthcare

provider’s instructions.

 Meter

GSH Blood Glucose Monitoring System Model R5228 should only be used for

testing single patient.

 Please test your blood glucose using the meter and the test strips with the

same reference number as labeled on the outer box of meter and the test

strips.

Limitations

1. Do not use for neonatal blood glucose testing or use the system for the

diagnosis or screening of diabetes.

2. Alternate site testing should not be used for CGM calibration or for insulin

dose calculations.

3. Hematocrit in the range of 20~60% does not affect the glucose results.

4. Cholesterol level up to 500 mg/dL(12.9 mmol/L) and Triglycerides up to 3,000

mg/dL(99.3mmol/L) have been shown not to affect glucose results.

5. Interference was observed for therapeutic levels of Glutathione.

6. Certain substances occurring in the blood naturally, such as uric acid, or from

normal therapeutic treatments (Ascorbic acid, L-Dopa, Tolazamide and Gentisic

acid) will not significantly affect results. However, higher concentrations in

blood may cause incorrect results.

7. There is no significant interference in the presence of galactose, maltose, or

fructose observed in blood glucose test.

8. Do not test blood glucose during or soon after xylose absorption test. Xylose

in the blood can give falsely elevated results.

9. The test strips may be used at altitudes up to 10,744 feet (3,275 m) without an

effect on test results.

10. Persons suffering from severe dehydration should not be tested using a

capillary whole blood sample.

11. Test results below 70 mg/dL(3.9 mmol/L) indicate low blood glucose

(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L )

indicate high blood glucose (hyperglycemia). If you get results below 70

mg/dL(3.9 mmol/L)or above 240 mg/dL(13.3 mmol/L), repeat the test, and

if the results are still below 70 mg/dL(3.9 mmol/L)or above 240 mg/dL(13.3

mmol/L), please consult your healthcare professional immediately2.

12. Not for use on critically ill patients, patients in shock, dehydrated patients or

hyper-osmolar patients.

TABLE OFCONTENTS

Understanding Your New System

Introduction 2-3

Test Principle 3

Appearance and Key Functions of the Meter 4

LCD Screen Overview 5

Installing/Replacing the Batteries 6

Settings (Date/Time/Alarm/Measuring Unit/Memory Deletion) 7-9

Performing a Control Test

About Control Solution Tests 10

Running a Control Solution Test 11-12

Testing Your Blood Sugar

Alternate Site Testing 13

How to Obtain a Blood Sample 14-15

Running a Blood Glucose Test 16-17

Recalling the Memory and Viewing the Average 18-19

Expected Values 20

Transmitting Results 20

Maintenance and Troubleshooting

Maintenance of Your System 21-24

Troubleshooting 25-26

Customer Service 27

Important Additional Information

Specifications 28

Ordering Supplies 28

Warranty Information 29

NOTE: For information about the name of the manufacturer of the lancing device

and the lancets, please refer to the package inserts that came with your

starter kits.

Understanding Your New System

Introduction

Intended Use / Indications for Use

The GSH Blood Glucose Monitoring System (Model R5228) is intended to be used for

the quantitative measurement of glucose in fresh capillary whole blood drawn from

the fingertips or forearm. The GSH Blood Glucose Monitoring System (Model R5228)

is intended to be used by a single person and should not be shared.

The GSH Blood Glucose Monitoring System (Model R5228) is intended for

self-testing outside the body(in vitro diagnostic use) by people with diabetes at

home as an aid in monitoring the effectiveness of a diabetes control program.

The GSH Blood Glucose Monitoring System (Model R5228) should not be used for

the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing

should be done only during steady state times (when glucose is not changing rapidly).

The GSH Test Strips are for use with the GSH Blood Glucose Meter to quantitatively

measure glucose in fresh capillary whole blood drawn from the fingertips or

forearm.

The GSH Control Solutions are for use with the GSH Blood Glucose Monitoring

System (Model R5228) as a quality control check to verify that the meter and test

strips are working together properly.

Contents of the System

This User Guide has been prepared to describe the proper use of the GSH Blood

Glucose Monitoring System Model R5228. Please read this User Guide and the

package insert that comes with the GSH Glucose Test Strips before testing. The

system is available either as a meter alone or as a kit. If you have a meter only, you

can purchase the system supplies from your system provider. Please provide to your

system provider with the 4 digit system reference number marked on the packaging

box when you purchase supplies.

The starter kit of GSH Blood Glucose Monitoring System Model R5228 includes the

following items:

1. GSH Glucose Meter with 2 AAA batteries

2. User Guide

3. Log Book

4. Carrying Case

5. GSH Glucose Test Strips

6. GSH Control Solution (Level II)

7. Sterile Lancets

8. Lancing Device

9. Package Inserts for Test Strips, Control Solution, and Lancets/Lancing Device

A single level control solution (Level II) is provided in the "Starter Kit," and no control

solution is included in the "Meter Only" kit. You may purchase GSH Control Solution

Level I, Level II or III from your system provider if needed.

The GSH Glucose Meter uses GSH Glucose Test Strips. Neither the meter nor the test

strips will work when used with any other brand of glucose products.

Test Principle

When glucose reacts with the reagents on the test strips, an electrical current is

produced, which is proportional to the glucose concentration in the blood sample.

The glucose concentration is calculated by the meter and based on the current

measured.

Appearance and Key functions of the meter

1. Test strip slot - When the strip is inserted into the slot, the meter will

automatically turn on.

2. LCD Display - Guide you through the test using symbols and simple messages.

3. M Key - Power ON/OFF, also for memory recalling mode, please refer to

manual for detailed function description.

4. C Key - Setting mode, please refer to manual for detailed function description.

5. Battery Compartment - Where batteries are located.

6. Ejector - Remove used strip.

LCD Screen Overview

1. Appears with the test result either in mg/dL or in mmol/L.

2. Appears when you recall the memory.

3. Appears when you are in setting mode.

4. Appears for control solution test flag.

5. Indicates the meter is ready to take the blood sample when it flashes.

6. Indicates the battery status.

7. Indicates current displayed result is an average.

8. Appears when alarm is on.

9. Month

10. Day

11. Hour

12. Minute

Installing/Replacing the Batteries

1. Turn off the meter by pressing “M” button and hold for 2 seconds before

replacing the batteries. Slide down the battery cover on the back of the meter

by pushing the cover in the direction of the arrow and put the cover aside.

2. Remove the two used batteries.

3. Insert 2 new batteries with correct +/- direction.

(Battery: AAA 1.5V 2 Alkaline 24A LR03)

4. Put the battery cover back in place by pushing the cover in the opposite

direction of the arrow to close the cover into position.

NOTE:

1. It is suggested that batteries need to be replaced when the battery icon

appears empty. If you keep using the meter, the battery icon will start

flashing and an error message E_3 will appear on the screen.

2. Note that replacing the battery will not reset the stored testing results.

3. You need to reset the time and date after the batteries are replaced.

4. If there is any unexpected symbol on the display, please follow the above

procedure to replace the batteries again.

5. Please dispose of batteries according to your local ordinances.