Hygiena CalCheck User manual

INS0213P Rev. C May 2021
CalCheck for EnSURE™Touch
LED Calibration Verification for Hygiena Luminometers
Cat No.: CAL
Description/ Intended Use:
CalCheck is a reusable device. Hygiena 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. Hygiena recommends verification of
luminometer calibration with CalCheck at a regular interval (e.g., weekly,
monthly) 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 calibration check.
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 connected to
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 repeat reading.
•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 technical support.
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 original packaging.
•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 before use.
•Take care to not press power button during storage as this will shorten
battery life.
•Replace CalCheck as needed. Refer to expiration date on label.
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 be replaced.
•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 along edge
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.hygiena.com or contact:
Hygiena —Americas
Phone: [phone]
E-mail: [e-mail]
Hygiena —International
Phone: [phone]
E-mail: [e-mail]

INS0213P Rev. C May 2021
CalCheck for EnSURE™and SystemSURE Plus™
LED Calibration Verification for Hygiena Luminometers
Cat No.: CAL
Description/ Intended Use:
CalCheck is a reusable device. Hygiena 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. Hygiena recommends verification of
luminometer calibration with CalCheck at a regular interval (e.g., weekly,
monthly) as specified by user-defined quality procedures.
Instructions:
Do not twist or bend CalCheck. Upon first use, CalCheck positive and
negative measurements must be recorded in Table 1 to serve as reference
for future calibration checks.
Negative Check:
1. Taking care not to press button on cap, insert CalCheck intoluminometer
and close lid.
2. Press “OK” to initiate measurement.
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 toturn
device on. Button will glow green to confirm activity. (If button glows red or
remains dark, battery should be replaced. See Battery Replacement).
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 of Results.
Table 1: Initial CalCheck Measurements
Instrument Serial No.:
Negative CalCheck RLU:
Positive CalCheck RLU:
Interpretation of Results:
Refer to Table 2 for in-calibration RLU ranges. Results from negative
CalCheck should be within RLU range in Table 2. Results from positive
CalCheck should be within RLU range in Table 2, or not vary by more than
±20% from initial positive CalCheck RLU as recorded in Table 1. If
CalCheck results are not within values in Table 2, or vary by more than
±20% from initial CalCheck RLU as recorded in Table 1, see
Troubleshooting.
Table 2: In-Calibration RLU Ranges for Hygiena Luminometers
EnSURE (RLU)
SystemSURE Plus (RLU)
Negative
0 –4
0 –4
Positive
140 –220
40 –80
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 repeat reading.
•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 technical support.
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 original packaging.
•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 before use.
•Take care to not press power button during storage as this will shorten
battery life.
•Replace CalCheck as needed. Refer to expiration date on label.
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 be replaced.
•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 along edge
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.hygiena.com or contact:
Hygiena —Americas
Phone: [phone]
E-mail: [e-mail]
Hygiena —International
Phone: [phone]
E-mail: [e-mail]