scigiene CalCheck User manual

Certified CalCheck for EnSURE™Touch
LED Calibration Verification for Hygiena Luminometers
Part Number: ATP4003-C
Description/ Intended Use:
CalCheck is a reusable device. Scigiene recommends incorporating
CalCheck into a quality control program to verify that the luminometer
continues to operate correctly and is within specifications. When powered
on by pressing the button on CalCheck's cap, the device emits a 3-second
green LED light output. In the off state, Calcheck can be used as a
negative control to alert users to background instrument light leakage or
rare sensor calibration errors. When certified yearly please refer to the
certified value on your certificate and the reading on you meter should
agree within 5% of this. Should this value not meet specification please
follow direction below for cleaning and battery replacement and repeat
test. If this fails then contact Scigiene immediately for help. Scigiene
recommends verification of luminometer calibration with CalCheck at a
regular interval (e.g., daily ) as specified by user-defined quality
procedures.
Instructions:
Do not twist or bend CalCheck.
1. Turn on EnSURE™Touch
2. Press the Pink Check Calibration App
3. Follow steps on screen to initiate negative calibrationcheck.
4. Follow steps on screen to initiate positive calibration check.
5. Upon completion, results are automatically recorded in the instrument
and will be synced to your SureTrend™Cloud account when connectedto
WiFi.
Troubleshooting:
Higher-than-expected CalCheck RLU readings indicate system calibration
failure. Physical contamination can cause lower-than-expected CalCheck
RLU readings.
•Clean outside of rod with lint-free cloth containing isopropyl or ethyl
alcohol. Air dry and repeatreading.
•For instructions on how to clean EnSURE™Touch please visit:
https://help.hygiena.com/kb-doc/how-to-clean-the-instrument/
•If issue is not resolved, contact Hygiena for technicalsupport.
Incorporating CalCheck into a Quality Control Program:
CalCheck is designed to be incorporated into a quality control program that
monitors and tracks performance of Hygiena luminometer(s). For optimum
recordkeeping, it is recommended that a specific location be programmed in
SureTrend™Cloud data analysis software for measuring CalCheck on
luminometer.
Storage & Shelf Life:
•Store at 10 –25 °C (50 –77 °F) in originalpackaging.
•If CalCheck is exposed to extreme temperatures (direct sunlight, heat,
refrigeration, or frozen), allow device to acclimate to ambient
temperature (10 –25 °C / 50 –77 °F) for 30 minutes beforeuse.
•Take care to not press power button during storage as this will shorten
battery life.
•Replace CalCheck as needed. Refer to expiration date onlabel.
•Keep CalCheck in box when not inuse.
Battery Replacement:
•When button cap glows red, CalCheck is not ready to perform a
positive check and may be approaching end of battery life. Wait 2
minutes and try again. If red light continues to appear, battery should
be replaced.
•If light remains dark upon pressing button, battery should bereplaced.
•CalCheck is powered by 1-CR1025 coin lithium battery (3V) available
from any common battery supplier. Battery door is located on
CalCheck’s black cap. Remove by inserting your fingernail alongedge
of door and gently removing cover. Insert new battery and replace
door.
Caution:
Wait 2 minutes between each positive reading. Repeatedly activating
CalCheck may drain battery prematurely.
Disposal:
CalCheck contains RoHS-compliant materials and a small battery. With
battery in place, CalCheck should be discarded as electronic waste. With
battery removed, CalCheck may be disposed as trash. CAUTION –RISK
OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE.
DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS.
Warranty:
Hygiena warrants CalCheck, when purchased new, to be free from defects
in materials and workmanship, and will repair or replace, at its discretion,
any CalCheck device which, used under proper conditions, exhibits such
defects. Under the terms of this warranty, the product must be returned in
the original packaging, transportation prepaid, with a copy of the Proof of
Purchase, to your local distributor. Contact your local distributor to receive
authorization to return the instrument, and enclose a detailed description of
the problem. This warranty is provided to the original purchaser for one year
from the date of purchase. In no event will Hygiena be liable for indirect,
incidental or consequential damages; the original user’s remedies being
limited to repair or replacement of CalCheck at the manufacturer’s option.
Unauthorized modification of any part of CalCheck, including removal of
labeling will void this Warranty.
Contact Information:
If more information is required, please visit www.scigiene.com or contact:

Certified CalCheck for EnSURE™and SystemSURE Plus™
LED Calibration Verification for Hygiena Luminometers
Part Number: ATP4003-C
Description/ Intended Use:
CalCheck is a reusable device. Scigiene recommends incorporating
CalCheck into a quality control program to verify that the luminometer
continues to operate correctly and is within specifications. When powered
on by pressing the button on CalCheck's cap, the device emits a 3-second
green LED light output. In the off state, Calcheck can be used as a
negative control to alert users to background instrument light leakage or
rare sensor calibration errors. When certified yearly please refer to the
certified value on your certificate and the reading on you meter should
agree within 5% of this. Should this value not meet specification please
follow direction below for cleaning and battery replacement and repeat
test. If this fails then contact Scigiene immediately for help. Scigiene
recommends verification of luminometer calibration with CalCheck at a
regular interval (e.g., daily ) as specified by user-defined quality
procedures.
Instructions:
Do not twist or bend CalCheck., CalCheck positive and negative
measurements must be recorded in your meter and verified against the
stated certified value on your certificate to serve as reference for future
calibration checks.
Negative Check:
1. Taking care not to press button on cap, insert CalCheck into luminometer
and close lid.
2. Press “OK” to initiatemeasurement.
3. Record initial negative CalCheck RLU in Table 1 below. For ongoing
testing refer to Interpretation of Results.
Positive Check:
1. Insert CalCheck into luminometer. Press button on CalCheck cap to turn
device on. Button will glow green to confirm activity. (If button glows red or
remains dark, battery should be replaced. See BatteryReplacement).
2. Close lid and press “OK” to initiate measurement.
3. Record initial positive CalCheck RLU in Table 1 below. For ongoing
testing, refer to Interpretation ofResults.
Troubleshooting:
Higher-than-expected CalCheck RLU readings indicate system calibration
failure. Physical contamination can cause lower-than-expected CalCheck
RLU readings.
•CalCheck: Clean outside of rod with lint-free cloth containing isopropyl
or ethyl alcohol. Air dry and repeatreading.
•EnSURE™: To remove the read chamber, open the lid of the
system, and insert your finger into the read chamber, and pull it out.
The read chamber can be washed with warm soapy water and
allowed to air dry. Once completely dry, the read chamber may be
replaced in the system. For instructions on further cleaning of
EnSURE™, please visit: help.hygiena.com/kb-doc/how-to-clean-
the-instrument.
•If issue is not resolved, contact Hygiena for technicalsupport.
Incorporating Certified CalCheck into a Quality Control Program:
The Certified CalCheck is designed to be incorporated into a quality
control program that monitors and tracks performance of Hygiena
luminometer(s). For optimum recordkeeping, it is recommended that a
specific location be programmed in SureTrend™data analysis software for
measuring CalCheck on luminometer.
Storage & Shelf Life:
•Store at 10 –25 °C (50 –77 °F) in originalpackaging.
•If CalCheck is exposed to extreme temperatures (direct sunlight, heat,
refrigeration, or frozen), allow device to acclimate to ambient
temperature (10 –25 °C / 50 –77 °F) for 30 minutes beforeuse.
•Take care to not press power button during storage as this will shorten
battery life.
•Replace CalCheck as needed. Please return to Scigiene yearly for
recertification
•Keep CalCheck in box when not inuse.
Battery Replacement:
•When button cap glows red, CalCheck is not ready to perform a
positive check and may be approaching end of battery life. Wait 2
minutes and try again. If red light continues to appear, battery should
be replaced.
•If light remains dark upon pressing button, battery should bereplaced.
•CalCheck is powered by 1-CR1025 coin lithium battery (3V) available
from any common battery supplier. Battery door is located on
CalCheck’s black cap. Remove by inserting your fingernail alongedge
of door and gently removing cover. Insert new battery and replace
door.
Caution:
Wait 2 minutes between each positive reading. Repeatedly activating
CalCheck may drain battery prematurely.
Disposal:
CalCheck contains RoHS-compliant materials and a small battery. With
battery in place, CalCheck should be discarded as electronic waste. With
battery removed, CalCheck may be disposed as trash. CAUTION –RISK
OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE.
DISPOSE OF USED BATTERIES ACCORDING TO THE INSTRUCTIONS.
Warranty:
Hygiena warrants CalCheck, when purchased new, to be free from defects
in materials and workmanship, and will repair or replace, at its discretion,
any CalCheck device which, used under proper conditions, exhibits such
defects. Under the terms of this warranty, the product must be returned in
the original packaging, transportation prepaid, with a copy of the Proof of
Purchase, to your local distributor. Contact your local distributor to receive
authorization to return the instrument, and enclose a detailed description of
the problem. This warranty is provided to the original purchaser for one year
from the date of purchase. In no event will Hygiena be liable for indirect,
incidental or consequential damages; the original user’s remedies being
limited to repair or replacement of CalCheck at the manufacturer’s option.
Unauthorized modification of any part of CalCheck, including removal of
labeling will void this Warranty.
Contact Information:
If more information is required, please visit www.scigiene.com or contact: