Sinocare Safe AQ Smart - User Manual

User Manual
For in vitro diagnostic use only
Safe AQ Smart、Safe AQ Voice、Safe AQ Air
Blood Glucose Meter
Blood Glucose Monitoring System
QI-QW-VPQ
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537 Hamburg, Germany.
Tel: +49-40-2513175 Fax: +49-40-255726
E-mail: shholding@hotmail.com
No. 265, Guyuan Road, Hi-Tech Zone, Changsha,
Hunan Province, 410205,People’s Republic of China
TEL:+86-731-89935581/89935582
FAX:+86-731-89825189
Email:info@sinocare.com Website:www.sinocare.com

Summary

Introduction to Your Blood Glucose Monitoring System

Intended Use

Specifies the intended application and scope of the blood glucose monitoring system.

Important Safety Information

Test Principle

Describes the scientific method used by the meter to measure glucose levels.

Patient Cautions

Important Health-Related Information

About Your Safe AQ Smart, Safe AQ Air, Safe AQ Voice Meter

Full Screen Display

Voice Function (For Safe AQ Voice only)

Explains how to enable and manage the voice output feature on the Safe AQ Voice meter.

Pairing (Connecting) Meter with Smartphone (For Safe AQ Air only)

Control Solution Testing

Performing a control solution test

Provides a step-by-step procedure for conducting a control solution test.

Blood Glucose Testing

Questionable Results

Lists common issues, their probable causes, and recommended actions for incorrect results.

Viewing test result

Memory

Information for Healthcare Professional Use

Comparing Meter with Laboratory Results

Cleaning and Disinfecting

Power Saving

Performance Characteristics

Specifications

Maintenance

Changing the batteries

Troubleshooting

Explanation of symbols

Warranty

References

Index

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Safe AQ Smart, Safe AQ Air, and Safe AQ Voice Blood Glucose Monitoring Systems are designed for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the fingertip and in venous whole blood samples. These systems are intended for in vitro diagnostic use, for self-testing and professional use as an aid in the management of diabetes. They are not intended for the diagnosis or screening of diabetes, for neonatal (newborn or infant) use, for use on critical patients, or for alternative site testing (AST) use.

Function Description

The blood glucose test is based on the measurement of electrical current generated by the reaction of glucose with special chemicals on the test strip's electrode. A blood or control solution sample is drawn into the test strip tip via capillary action. Glucose in the sample reacts with the chemicals, producing electrons and electrical current. The meter measures this current and calculates the glucose result, displayed in mg/dL or mmol/L. Each meter displays only one unit of measurement, which is preset and cannot be changed.

The Safe AQ Smart, Safe AQ Air, and Safe AQ Voice meters store up to 10 blood glucose test results in memory. Once 10 results are stored, adding a new result will delete the oldest one. To review results, with the meter off, press the main button for 1.5 seconds to turn it on. The meter will beep and display the last blood glucose test result. Briefly pressing the button again allows you to review previous results. Pressing the button for 3 seconds turns the meter off. Note that results cannot be reviewed when a test strip is in the port.

Usage Features

• Self-Testing and Professional Use: The meters and lancing devices are for single-person use only for self-testing. For professional use, if the meter is used on a second person, both the meter and lancing device must be disinfected first.
• Test Strips and Lancets: Safe AQ test strips and lancets are for single use only and must not be reused. Only Sinocare blood glucose control solution and Safe AQ test strips should be used with these meters.
• Error Indications:
  • If test results are greater than 600 mg/dL (33.3 mmol/L), the meter will display "HI". For Safe AQ Voice, it will also read "The result is beyond the range" with a red light. Retest immediately with a new strip. If still "HI", contact a healthcare professional.
  • If test results are lower than 20 mg/dL (1.1 mmol/L), the meter will display "LO". For Safe AQ Voice, it will also read "The result is below the range" with a red light. Retest immediately with a new strip. If still "LO", contact a healthcare professional.
  • For Safe AQ Voice, specific light indications are provided based on results: green light for >70 mg/dL and <126 mg/dL; yellow light for ≥126 mg/dL and ≤250 mg/dL; red light for ≤70 mg/dL or >250 mg/dL. These light indications should not be the sole basis for treatment changes; always consult a healthcare professional.
  • "E-2" or "The temperature is beyond the range"/"The temperature is below the range" indicates the environment temperature is outside the acceptable range (10℃~35℃). Move the meter, strip, and control solution to an appropriate place, wait 30 minutes, and retest.
  • "E-3" or "Test method error" indicates an issue with the blood glucose testing method. Review the testing section and use a new strip.
• Voice Function (Safe AQ Voice only): The Safe AQ Voice meter has a preset voice function. The voice switch is located inside the battery chamber. Sliding the switch to "on" activates the voice, and a "♪" symbol appears on the screen. Sliding it to "off" deactivates the voice, and the "♪" symbol disappears.
• Pairing with Smartphone (Safe AQ Air only): The Safe AQ Air meter can upload test results to a smartphone via Bluetooth Smart using a compatible app (e.g., Wechat App). Ensure Bluetooth is on, open the app, scan the QR code provided, link the device, insert a test strip (meter turns on), and if the Bluetooth symbol displays, the connection is successful. Test results will then be uploaded to the smartphone. If the Bluetooth symbol flashes, recheck Bluetooth settings and reinsert the strip.
• Control Solution Testing: Control solution tests ensure the meter and test strips are working correctly and allow practice without blood. Perform a control solution test when starting a new vial of test strips, if the vial cap has been open for a long time, if strips have been exposed to extreme environmental conditions, to check meter/strip functionality, if the meter is dropped or broken, or to verify correct test steps.
  • Use only Sinocare blood glucose control solution. Check the expiration date and discard date on the bottle. Do not use expired solution.
  • Test strips should be used within 6 months of opening the vial. Record the opened date on the control solution bottle and discard it after 3 months.
  • To perform a test: wash and dry hands. Insert a Safe AQ Test Strip (printing face up, contact end in) until it stops. The meter will turn on. Wait for the flashing blood drop symbol. Shake the control solution bottle well, discard the first drop, then apply a second drop to the test strip tip until the meter beeps. After a 5-second countdown, the result will display.
  • Control test results must be within the range printed on the test strip vial label. If out of range, retest. If still out of range, do not use the strips or meter for blood glucose testing and contact customer service.
• Blood Glucose Testing Steps:
  1. Wash and dry hands or use an alcohol swab to clean the fingertip.
  2. Unscrew the lancing device cover.
  3. Insert a lancet into the lancing device until it stops.
  4. Twist and pull to remove the lancet protector (retain for disposal).
  5. Screw the lancing device cover back on.
  6. Adjust the comfort tip for puncture depth (1-2 for soft/thin skin, 3-4 for average, 5 for thick/calloused).
  7. Pull the spring cover back to arm the lancing device.
  8. Take a strip from the vial and immediately close the lid. Finish the test within 3 minutes of taking out the strip.
  9. Insert the strip into the test strip port (printed side up, contact end in). The meter will turn on.
  10. Press the lancing device firmly to your finger and press the button to lance. Gently massage your finger if not enough blood. Do not squeeze.
  11. When the meter displays a flashing blood symbol, apply the blood sample to the reaction chamber. Hold the strip tip to the blood drop until the meter beeps. Visually confirm the sample fills the entire chamber. Do not move the meter or strip or press the main button during testing. If insufficient blood, use a new strip. Do not press the strip firmly against the finger.
  12. After a 5-second countdown, the meter displays the test result.
  13. Eject the strip.
  14. Remove the lancing device cover. Stick the used lancet needle into its protector, eject the lancet, and screw the cover back on.
• Power Saving:
  • If no blood is applied to the test strip within 3 minutes, the meter automatically turns off.
  • After a test, if no operation occurs within 3 minutes while the test strip is in the port, the meter automatically turns off.
  • If the test result displays "LO" or "HI", the result is displayed for 1 minute. If no other operation occurs within 1 minute, the meter turns off.
  • If no other operation occurs within 1 minute (e.g., in review mode), the meter automatically turns off.

Maintenance Features

• General Care:
  • Avoid dirt, dust, blood, control solution, or liquids entering the meter test port.
  • Do not keep the meter in an area where it may be crushed.
  • Store the blood glucose monitoring system (meter, test strip, control solution) in a dry place.
  • Do not freeze.
  • Do not store in the kitchen or bathroom.
• Cleaning and Disinfecting:
  • Clean and disinfect the meter immediately if any blood gets on it or if it is dirty.
  • If the meter is used on a second person, the meter and lancing device must be cleaned and disinfected first. Do not clean the meter during a test.
  • To clean: Wash hands thoroughly with soap and water. Ensure the meter is off and no test strip is inserted. Use 75% alcohol to rub the entire outside of the meter, ensuring no liquids enter the test strip port or other openings. Let the meter air dry thoroughly. Wash hands again after handling. Verify proper function with a control solution test. If issues persist, contact customer service.
  • To disinfect: Follow clinic institution disinfection methods.
• Battery Replacement:
  • Ensure the meter is off. Slide the battery cover out. Remove old batteries and insert new ones according to the "+" and "—" markings. Slide the cover back until it locks.
  • Caution: Keep batteries away from children. If swallowed, call a healthcare professional immediately.
  • Low battery power will be indicated by "E-1". Replace batteries immediately.
  • If the meter does not turn on after inserting a test strip, check if the battery is installed correctly. If the test strip is inserted incorrectly, reinsert it correctly. If there is no display, remove the battery, wait 3 minutes, and reinstall. If still no display, contact customer service.

Sinocare Safe AQ Smart Specifications