Hygiena CalCheck - User Manual

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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: 1.805.388.8007

E-mail: info@hygiena.com

Hygiena — International

Phone: +44 (0)1923 818821

E-mail: enquiries@hygiena.com

Need help?

Do you have a question about the Hygiena CalCheck and is the answer not in the manual?

Summary

Product Description and Usage

Intended Use

Describes CalCheck as a reusable device for verifying luminometer calibration.

Instructions for Use

Details the steps for performing negative and positive calibration checks with the CalCheck device.

Quality Control and Maintenance

Incorporating CalCheck into Quality Control

Guidance on integrating CalCheck into a quality control program for performance monitoring.

Storage and Shelf Life

Recommendations for storing the CalCheck device to maintain its integrity and performance.

Battery Replacement

Instructions on how to replace the battery when it is depleted.

Troubleshooting and Support

Troubleshooting

Information on interpreting readings and resolving issues like unexpected RLU values.

Contact Information

Details for contacting Hygiena for further assistance or information.

System Specific Instructions

EnSURE and SystemSURE Plus

Specific instructions for using CalCheck with EnSURE™ and SystemSURE Plus™ luminometers.

Interpretation of Results

Guidance on how to interpret the RLU ranges for calibration verification.

Summary

Product Description and Usage

Intended Use

Describes CalCheck as a reusable device for verifying luminometer calibration.

Instructions for Use

Details the steps for performing negative and positive calibration checks with the CalCheck device.

Quality Control and Maintenance

Incorporating CalCheck into Quality Control

Guidance on integrating CalCheck into a quality control program for performance monitoring.

Storage and Shelf Life

Recommendations for storing the CalCheck device to maintain its integrity and performance.

Battery Replacement

Instructions on how to replace the battery when it is depleted.

Troubleshooting and Support

Troubleshooting

Information on interpreting readings and resolving issues like unexpected RLU values.

Contact Information

Details for contacting Hygiena for further assistance or information.

System Specific Instructions

EnSURE and SystemSURE Plus

Specific instructions for using CalCheck with EnSURE™ and SystemSURE Plus™ luminometers.

Interpretation of Results

Guidance on how to interpret the RLU ranges for calibration verification.

The CalCheck device, available for EnSURE™ Touch, EnSURE™, and SystemSURE Plus™ luminometers, is a reusable LED calibration verification tool designed to ensure the accurate and consistent operation of Hygiena luminometers. It is intended to be integrated into a quality control program to verify that the luminometer continues to operate correctly and remains within specified parameters.

Function Description

The CalCheck device emits a 3-second green LED light output when its cap button is pressed, indicating a positive calibration check. In its off state, CalCheck can also serve as a negative control, helping to detect background instrument light leakage or rare sensor calibration errors. Regular verification of luminometer calibration with CalCheck, at intervals specified by user-defined quality procedures (e.g., weekly, monthly), is recommended.

For EnSURE™ Touch, the calibration process involves:

Turning on the EnSURE™ Touch.
Pressing the Pink Check Calibration App.
Following on-screen steps to initiate a negative calibration check.
Following on-screen steps to initiate a positive calibration check.
Upon completion, results are automatically recorded in the instrument and synced to the SureTrend™ Cloud account when connected to WiFi.

For EnSURE™ and SystemSURE Plus™, the process is similar: Negative Check:

Insert CalCheck into the luminometer, taking care not to press the button on the cap, and close the lid.
Press "OK" to initiate measurement.
Record the initial negative CalCheck RLU (Relative Light Unit) in a provided table. Positive Check:
Insert CalCheck into the luminometer. Press the button on the CalCheck cap to turn the device on. The button will glow green to confirm activity. (If the button glows red or remains dark, the battery should be replaced.)
Close the lid and press "OK" to initiate measurement.
Record the initial positive CalCheck RLU in a provided table.

Important Technical Specifications

Battery:

CalCheck is powered by a 1-CR1025 coin lithium battery (3V).
Battery life is indicated by the button cap's glow: red glow indicates low battery and approaching end of life; no glow indicates a dead battery.
The battery door is located on CalCheck's black cap and can be removed by inserting a fingernail along the edge.

RLU Ranges for Hygiena Luminometers (In-Calibration):

EnSURE™ (RLU):
- Negative: 0-4
- Positive: 140-220
SystemSURE Plus™ (RLU):
- Negative: 0-4
- Positive: 40-80

Storage & Shelf Life:

Store at 10-25 °C (50-77 °F) in original packaging.
If exposed to extreme temperatures (direct sunlight, heat, refrigeration, or freezing), allow the device to acclimate to ambient temperature (10-25 °C / 50-77 °F) for 30 minutes before use.
The device contains RoHS-compliant materials.

Usage Features

Reusable Device: Designed for repeated use in quality control programs.
Dual Functionality: Serves as both a positive calibration check (emitting green LED light) and a negative control (when off, to detect light leakage).
Automated Recording (EnSURE™ Touch): Results are automatically recorded in the instrument and synced to the SureTrend™ Cloud.
Battery Indicator: The button cap glows red when the battery is low, prompting replacement.
Caution for Use: Wait 2 minutes between each positive reading to prevent premature battery drain. Avoid twisting or bending the CalCheck device.

Maintenance Features

Cleaning:

CalCheck: Clean the outside of the rod with a lint-free cloth containing isopropyl or ethyl alcohol. Air dry before repeating readings.
EnSURE™/SystemSURE Plus™ Read Chamber:
- EnSURE™ Touch: Refer to the instrument manual for cleaning instructions.
- EnSURE™/SystemSURE Plus™: The read chamber can be removed by inserting a finger and pulling it out. It can be washed with warm soapy water and air-dried.
- For further cleaning instructions for EnSURE™ Touch, visit help.hygiena.com/kb-doc/how-to-clean-the-instrument.

Battery Replacement:

If the button cap glows red, wait 2 minutes and try again. If it persists, replace the battery.
If the light remains dark when pressing the button, replace the battery.
To replace, remove the battery door on the black cap by inserting a fingernail along the edge, gently removing the cover, inserting a new battery, and replacing the door.
Dispose of used batteries according to instructions.

Troubleshooting:

Higher-than-expected RLU readings: Indicate system calibration failure.
Lower-than-expected RLU readings: May be caused by physical contamination.
If issues are not resolved after cleaning and battery replacement, contact Hygiena technical support.

Disposal:

With the battery in place, CalCheck should be discarded as electronic waste.
With the battery removed, CalCheck may be disposed of as trash.
Dispose of used batteries according to instructions.

Warranty: Hygiena warrants CalCheck to be free from defects in materials and workmanship for one year from the date of purchase. Defective products will be repaired or replaced at Hygiena's discretion. The product must be returned in its original packaging, transportation prepaid, with a copy of the Proof of Purchase, to the local distributor. Unauthorized modification of any part of CalCheck, including removal of labeling, will void the warranty.