Rightest GM700 Pro 2 User manual

101-3GM762-XXX EN(US)
Rev. Date: 2021-01
User’s Manual
GM700 Pro 2
Rx Only
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
Email: [email protected]om
http://www.bionime.com
Made in Taiwan
USA Customer Service Center:
Ontario, CA 91761, USA
Tel: [phone]
Fax: [phone]
http://www.bionimeusa.com
Service hour: Mon. to Fri.
8:00 AM to 5:00 PM PST.
For EMERGENCY, please contact the
healthcare professional.
Blood Glucose Monitoring System

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Preface
Thank you for choosing the RIGHTEST Blood Glucose Monitoring System GM700 Pro 2. This
product is manufactured by Bionime Corporation and distributed by authorized dealers. Please
read this manual carefully before use and follow the instructions. If you have any questions
regarding this product, please call our customer service [phone] (Service hour: Mon. to
Fri. 8:00 AM to 5:00 PM PST), or contact a local distributor.
The RIGHTEST Blood Glucose Monitoring System GM700 Pro 2 should be used with RIGHTEST
Test Strip GS770 or GS700 and RIGHTEST Control Solution GC700.

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CLIA Complexity Indication for Use
This test is WAIVED for capillary (draw from ngertip, palm and forearm) and venous whole
blood under the Clinical Laboratory Improvements Amendments of 1988 (CLIA).
Laboratories with a Certicate of CLIA waiver can perform this test in a waived setting and must
follow the manufacturer’sinstructions for performing the test. If a laboratory modies the test
instructions, the test will no longer be considered waived.
(Refer to the section of "CLIA Waiver Study Results/System Accuracy Result").
This manual provides all necessary instructions for the routine operation and maintenance of the
RIGHTEST Blood Glucose Meter GM700 Pro 2. Please read this manual carefully. It has been
prepared to help you attain optimum performance from your Meter.
The RIGHTEST Blood Glucose Monitoring System GM700 Pro 2 consists of the The RIGHTEST
Blood Glucose Meter GM700 Pro 2 and The RIGHTEST Blood Glucose Test Strip GS770.
The RIGHTEST Blood Glucose Monitoring System GM700 Pro 2 is intended for Point-of-care, in
vitro diagnosis, multiple-patients use for quantitative determination of glucose in capillary blood
(draw from ngertip, palm and forearm) and venous whole blood. Whole blood glucose results
are equivalent to plasma results with biochemical analyzer.
The system is intended for use at clinical environments (ie. genenral primary care centers,
outpatient settings for endocrinology and metabolism).
When testing from the ngertip, only single-use, auto-disabling lanceing device should be used.
For alternative site test, single person use lancing device should be used, and the testing could
only perform during steady state time (when there is no rapid change in glucose).
The system is not intended for the screening or diagnosis of diabetes mellitus.

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RIGHTEST Blood Glucose Monitoring System
1.1 RIGHTEST Blood Glucose Monitoring System
1.2 RIGHTEST Blood Glucose Meter GM700 Pro 2
1.3 RIGHTEST Charging Hub
1.4 RIGHTEST Test Strips
1.5 Auto-Code Holder
1.6 Sample Size Example
1.7 Interfering Substances
1.8 Limitation
1.9 Product safety and important Information
Installation
2.1 Installing RIGHTEST GM700 Pro 2
2.2 Installing the Charging Hub
2.3 System Connection
2.4 Recharging the Battery
General Operation
3.1 Power on/o󰀨
3.2 Power saving mode and waking up
3.3 User login
3.4 Device information
3.5 Bluetooth connection
Blood Glucose Measurement
4.1 Patient search
4.2 How to enter test strip information
4.3 Wait for the test strip to be detected
4.4 Sample collection
4.5 Checking test results
4.6 Making a test note
4.7 Patient prole
Quality Control
5.1 Select control solution concentration
5.2 How to enter the control solution information
5.3 How to enter the test strip information
5.4 Wait for the test strip to be detected
5.5 Prepare the control solution and take a measurement
5.6 Check the test result
Table of Contents Table of Contents
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RIGHTEST Blood Glucose Monitoring SystemTable of Contents
5.7 Making a QC fail note
Advanced Quality Control
6.1 Linear quality control
6.2 External quality control
Maintenance and Care
7.1 Maintenance
7.2 Cleaning and disinfecting procedure
7.3 Cleaning the metal contact point
Error Messages and Troubleshooting
Specications
Customer Service/Warranty
Symbols
CLIA Waiver Study Results/System Accuracy Result
FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT
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1.1 RIGHTEST Blood Glucose Monitoring System
Your RIGHTEST Blood Glucose Monitoring System GM700 Pro 2 contains the following:
1. RIGHTEST Meter GM700 Pro 2 (with built-in rechargeable lithium battery)
2. Charging hub
3. Power cable*
4. Network cable*
5. User's manual
6. RIGHTEST Test Strip GS770 (with insert)*
7. RIGHTEST lancing device GD500 (with insert)*
8. Transparent cap for lancing device*
9. RIGHTEST lancet*
10. RIGHTEST Control Solution GC700 (Level 1, 2, 4) (with insert)*
(Contents may vary. Items marked with "*" may be supplied separately.)

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RIGHTEST Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System
1.2 RIGHTEST Blood Glucose Meter GM700 Pro 2 1.3 RIGHTEST Charging Hub
Test Strip Port
Insert test strips here.
Power Button
QR code/
Barcode Scanner
Auto-Code
Holder
LCD Display/
Touch Screen
Displays
information and
support touching
operation.
Main Button Product Label
Information
includes model,
batch number
and serial number. Network socket Power port

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RIGHTEST Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System
1.4 RIGHTEST Test Strips
The RIGHTEST Blood Glucose meter GM700 Pro 2 can only be used with RIGHTEST Blood
Glucose Test Strip GS770 and the strip should be used with RIGHTEST Control Solution GC700.
Sample Port
Apply a drop of blood or control solution.
Handle Bar
Hold the handle
when moving
the strip around.
Electrode Contact
Sensor signal output
terminal.
Noble Metal
Electrodes
Electrochemical
sensor.
Indication Symbol
Insert the test strip with the indication
symbol fpointing towards the meter.
Viewing Window
The viewing window appears yellow before
blood is applied. It turns red after being lled
with blood.
Important information
- Please refer to the Blood Glucose Test Strip GS770 insert for details.
- If the blood glucose meter or test strip are exposed to a sudden increase or drop in
temperature or been placed outside the recommended operating temperature range
(43 - 111°F or 6 - 44°C), please wait 60 minutes before using the meter and 30
minutes before using the test strip.

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1.6 Sample Size Example
The recommend sample volume is 0.75 to 3.0μL. Too large sample may contaminate the auto-
code holder, too small sample may lead to the error message (error code 1004). If this occurs,
repeat the test with a new test strip (For detail indication about sample size, please refer to Blood
Glucose Test Strip GS770 Insert).
1.7 Interfering Substances
Before use, please refer to the RIGHTEST Blood Glucose Test Strip GS770 Insert for information
on interfering substances.
1.8 Limitation
- This product is not intended for use at more than 10,745 feet (3,275m) above sea level.
- This product is not intended for plasma or serum testing. Please use a whole blood sample.
- Before use, please carefully read the RIGHTEST Blood Glucose Test Strip GS770 Insert. (which
contains information on blood samples, hematocrit, and interfering substances).
RIGHTEST Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System
1.5 Auto-Code Holder
The auto-code holder automatically detects the code of a test strip. Our test strips deliver
consistent performance without manual coding. The auto-code holder is reusable. When
the auto-code holder is contaminated or damaged, please contact our customer service for
replacement and installation.
Important information
- The auto-code holder automatically calibrates the strip when inserted into the device.
The auto-code holder is reusable unless damaged of contaminated. However, strips
are intented for single use only.
- If the auto-code holder is not functioning properly, please contact our customer
service. Do not try to remove it on your own.

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RIGHTEST Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System
1.9 Product safety and important Information
1.9.1 General safety information
Please carefully read the following sections to ensure safe use of the device.
- To ensure your safety during operation, please read the entire user's manual, test strip insert,
and other instructional materials thoroughly before starting usage.
- We recommend a performance comparison test between the device and and a laboratory
reference device once per year. If any problems arise, please contact our customer service.
1.9.2 Battery
The device uses a rechargeable lithium battery. If the battery does not recharge or is damaged,
please contact customer service for a replacement. Do not try to remove or replace the battery
on your own.
1.9.3 RIGHTEST Charging Hub
- Do not use alcohol or any liquid to wipe the network socket or power port on the back of the
charging hub.
- The charging status will be on when the device is on the charging hub. The charging status will
display through the main button on device. Orange means the device is charging. Green means
the device is fully charged. Do not use the device while charging.
Warning
- Keep the device away from strong electromagnetic radiation to prevent interference
with proper operation of the meter.
- Keep your meter and test strip away from dust, water or any other liquid.
- Disposal of this product: This product contains lithium batteries. The entire system
become infectious during the course of use. Please discard it in accordance with local
regulations for biohazardous waste. If you don't know what to do, please contact our
customer service.

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RIGHTEST Blood Glucose Monitoring System RIGHTEST Blood Glucose Monitoring System
1.9.4 Touch Screen
The touch screen is designed to be operated with a ngertip or stylus. Do not use any other kind
of pen or sharp object as this may damage the touch screen.
1.9.5 Barcode Scanning
- Do not scratch the barcode scanning lens at the bottom of the device as this may cause issues
with scanning. Do not look directly into the light or point it at another person's eyes when the
scanner is on.
- Please hold the scanner approximately 7 cm above a barcode and allow the light to cover the
entire barcode. Adjust the position of the scanner until the barcode can be read successfully.
1.9.6 Static Electricity Protection
- Keep the device away from strong electromagnetic radiation sources to prevent interference
with proper operation of the meter.
1.9.7 Network Security
- Communication mode: WiFi, LAN (Ethernet hub), and Bluetooth (4.0).
- User management: Login requires an account number and password. Switch user as needed to
manage login access.
- Users are responsible for information security over the Internet and the setup of a secure IT
environment. Use of the device is subject to the information security guidelines of the system to
which the device is connected.
1.9.8 LAN Connection
- When the device is LAN-enabled. Test results can be uploaded to hospital systems via HTTPS.
1.9.9 WiFi Connection
- When device is WiFi-enabled. Test results can be uploaded to hospital systems via HTTPS.
- Please set up a WiFi connection according to the WiFi connection requirements of your
individual hospital.
- WiFi signals are vulnerable to the surrounding environment. The actual transmission distance
and performance will be a󰀨ected by the user's surroundings.
- When connecting the device to the Internet, please check the security settings.
- The WiFi connection should be congured by your system administrator according to your local
environment.
1.9.10 Biohazardous
The used strip, auto-disabling lancing devices, and lancet should be considered biohazards
waste. Collect these wastes in suitable puncture-proof containers with biohazard labels and
discard them in accordance with local regulations.