Rossmax HS200 User manual

Caution: Control Solution is for in vitro use only. It is not to be swallowed or injected. The use of the
Control Solution is recommended to verify proper system performance and should not be considered
as a substitution of actual capillary whole blood testing for blood glucose level.
Materials Required
1. Glucose Meter
2. Test Strip
3. Control Solution
Note: Please make sure you are using the same model of Control Solution, Test Strip and
Glucose Meter.
Test Procedure
Note: Make sure the solution is at room temperature15°C to 35°C (59°F to 95°F) prior to testing.
Preparation
Make sure that you have set the Glucose Meter in the Control Solution test “ “ mode, so the result
will be stored in the memory and not be incorporated into the average. Please read the User Manual of
your Rossmax HS200 Blood Glucose Monitoring System.
Testing
Intended Use
The Control Solution is a desired aqueous glucose solution with small amounts of non-reactive
ingredients and food coloring for verifying the accuracy of the entire Rossmax HS200 Blood Glucose
Monitoring System. The control solutions are used to check the performance of the Rossmax HS200
meter, test strips, and your testing technique.
When To Perform a Control Solution Test
1. You get your meter for the first time before testing your blood test.
2. You open a new vial of test strips.
3. You want to check the meter and strips.
4. You suspect that the meter or test strips are not working properly.
5. Your blood glucose test results are not consistent with how you feel.
6. You think your test result does not accurate.
7. You dropped your meter.
8. Whenever your healthcare professional recommends it.
Control Solution Contents
Each Control Solution is provided as a buffered, stabilized, aqueous solution of desired D(+)-glucose
containing a preservative and other non-reactive ingredients. The solutions are formulated to react
equivalently to a whole blood sample containing approximate 50, 130 or 350 mg/dL glucose
concentrations. Actual lot-specific ranges are printed on the Test Strip bottle label.
Control Solution
Level 1
Level 2
Level 3
mg/dL
50
130
350
mmol/L
2.8
7.2
19.4
Control Solution Package Insert
HS200
1. Insert a Rossmax HS200 Blood Glucose Test Strip into the test port. The meter will be automatically
turned ON. When test strip is inserted, a beep will sound if the buzzer is turned on and the system
checking will appear followed by a flashing “ ” icon.

Result is out of range may be caused by:
● Incorrect steps taken in performing the test.
● The Control Solution temperature is not within 15°C(59°F)- 35°C(95°F) prior to testing.
● The Control Solution may be expired or contaminated or has been opened over 3 months.
● Expired or contaminated Test Strips.
● Meter malfunction.
If the problem persists, the system may not be working properly. DO NOT continue to use the system to
test your blood glucose level. If you continue to get results that fall outside the specified range, please
return the device to your local distributor or service center.
Storage and Stability
For best results, store Control Solution at room temperature; do not refrigerate. Refer to the expiration
date for stability. The solution should NOT be used after the expiration date or 3 months after opening.
Explanations of Symbols
Caution:
● Use the same model of Control Solution, Test Strip and Glucose Meter.
● DO NOT apply Control Solution to the Test Strip directly from the bottle, such operation could be
leaded to contaminate and decrease the concentration of Control Solution. You MUST place a drop
of Control Solution on a clean nonabsorbent surface first.
● Only for use outside the body (For in vitro diagnostic use).
Medical Device Safety Service GmbH
Schiffgraben 41, D-30175 Hannover, Germany
Tyson Bioresearch, Inc.
5F, No. 16, 18, 20, 22, Kedong 3rd Rd.,
Zhunan Township, Miaoli County 35053, Taiwan
Consult instructions for use
Catalogue number
Do not use if package is damaged
Batch code
Authorised Representative in the European Community
Control
2. Press and hold button for 2 seconds to change to the Control Solution test mode. " " will appear
on the display. If button is pressed again for 2 seconds, the meter will switch back to the normal
testing mode.
3. Shake the Control Solution gently. Discard the first drop of the Control Solution and squeeze a small
drop on a clean nonabsorbent surface such as a clean piece of wax paper. Do not apply the Control
Solution to the test strip directly from the bottle, as contamination may occur.
4. Introduce the tip of the test strip to the droplet of the Control Solution. The Control Solution is automatically
drawn into the strip. Hold until the meter beeps. The meter will now start to count down and the
Control Solution test result will appear on the LCD screen.
5. Compare the results with the Control Solution range printed on the Test Strip vial. The results should
fall within the specified range listed on the Test Strip vial. If the test result is out of the range, repeat
the test.
IN5HS200000000030
Rossmax Swiss GmbH, 9435 Heerbrugg, Switzerland
www.rossmax.com
OBM_OP_HS200_ ControlInsert_EN_ver2122
Temperature limitation
Manufacturer
Keep away from sunlight
Use by
In vitro diagnostic medical device