BETACHEK C50 Instructions For Use

BETACHEK
®
C50/G5 Control Solutions
Instructions for use
Device for self-testing
Intended use: For use with BETACHEK
®
C50 or G5 Blood Glucose monitoring systems as a quality control
check to verify accuracy. Suitable for self-testing.
Description: BETACHEK
®
C50/G5 Control Solutions are water based solutions containing a known amount of
glucose which when used in place of blood will react with BETACHEK
®
G5 Test Strips or C50 test cassettes. The
Control Solution should give results within the expected range printed on the container label. Obtaining a result
within the expected range is sufficient to verify system performance.
When to carry out a control test: Control Solution should be used
• If you obtain unexpected results.
• After opening a new pack of test strips or test cassette
• After you have replaced the batteries.
• After you have cleaned your meter.
• Whenever you suspect the meter or test strips may not be functioning properly.
Use of Control Solution is also recommended for teaching or learning how to use the system.
Contents of the pack: 1 package insert, glucose Control Solution (see outer packaging for quantities).
Also required: BETACHEK
®
C50 or G5 Meter and instruction manual, BETACHEK
®
C50 Cassette or G5 Test Strips
Chemical composition
1
Control 1
Glucose 0.03
Buffer 0.70
Preservative 0.40
Non reactive constitu-
ents
18.00
Water 80.87
1
Values are expressed as a percentage by weight and vary depending on the control level. Figures given are for control 1.
Precautions and limitations
• For in vitro diagnostic use only.
• Do not allow Control Solution to enter the meter, use only on cassettes/test strips.
• Discard any unused Control Solution 3 months after opening. Note the discard date on the Control
Solution label.
• Use a fresh test zone/strip if the drop of Control Solution has not completely wet the test pad.
• Use one drop of Control Solution only. If several drops were applied repeat the test.
• If the drop applied contained air bubbles, repeat the test.
Storage and handling
• Store the Control Solution between 2 and 30ºC (35 and 85ºF).
• Use before the expiration date shown on the label.
• Wipe the bottle tip and reseal tightly after each use.
C50/

BETACHEK C50 Specifications

General

Number of Tests per Cassette	50
Blood Sample Size	0.6 μL
Test Time	5 seconds
Blood Sample	Capillary whole blood
Connectivity	USB
Relative Humidity	10 - 90%
Battery Type	2 x AAA batteries
Measuring Range	1.1 - 33.3 mmol/L
Operating Temperature	10 - 40 °C