0123 0123
Physical Module Calibrator Physical Module Calibrator
Initial Version and minutes; seek medical treatment immediately if pain or Performance Characteristics
01, 2024-01-15
Issue Date swelling occurs. In case of contact with skin, rinse the skin Trueness: Trueness of measuring value transfer |En|≤1.
Current Version and with soapy water, and completely rinse off the product with Homogeneity: level 2 and level 3: CV between-bottle≤5%.
03, 2024-11-20
Revision Date clean water.
Document ID 3-02-70-01-1206-00-01 This product is only applicable to the calibration of
conductivity, specific gravity and turbidity module of Zybio Technical assistance
Model / urinalysis system. Please do not use it for other purposes. For customer support, contact your local technical support
Language English The value assignment of calibrators varies with different provider or distributor.
batches. See bottle label for specific indicated value.
Urine Chemistry Analyzer (Models: Avoid contact with the skin and eyes. If this product is
U1600, U1601, U1602) References
splashed into eyes, rinse with running warm water for several
manufactured by Zybio. 1. China Committee for Clinical Laboratory Standards,
minutes; seek medical treatment immediately if pain or
Urine Sediment Analyzer (Models: Urinalysis and Collection, Transportation and Preservation of
U2600, U2601, U2602, U2610, swelling occurs. In case of contact with skin, rinse the skin
Systems Urine Specimens; Approved Guideline-Translated from
U2611, U2612) manufactured by with soapy water, and completely rinse off the product with
NCCLs Document GP16-A, 1995
Zybio. clean water.
2. Cong Yulong, Ma Junlong, et al. Modern Urinalysis
Urinalysis Hybrid System (Models: Please use this product as required in the instructions. The
Techniques and Clinical Application, China Science &
U3600, U3601, U3602) accuracy of the results cannot be guaranteed for purposes
Technology Press, 1998
manufactured by Zybio. other than the prescribed instructions and intended purpose.
3. Cong Yulong, Ma Junlong et al. Practical Urinalysis
Instructions for use must be carefully followed, reliability of Routine precautions for laboratory operations must be
assay results cannot be guaranteed if there are any deviations. Techniques and Clinical Application, People ’ s Medical
followed when this product is used.
Publishing House, First Edition, September 2013
For in vitro diagnostic use only. The product contains hazardous chemical substance. Wear
protective gloves/ protective clothing/eye protection/face
protection in the lab, so as to protect yourself when using. Symbol Interpretation
Intended purpose Disposal into drain systems must be in compliance with
This product is used for specific gravity, turbidity and prevailing regulatory requirements. Title and Title and
Symbol Symbol
conductivity calibration of PHYC module on Zybio urinalysis The calibrator that was opened shall be sealed and stored Description Description
systems. as instructed, and do not use expired product. In vitro
This product shall be stored as instructed, and kept away diagnostic Batch code
from direct sunlight during operation. medical device
Assay Principles
Do not freeze during transportation. Consult
The calibrator of a known concentration is measured for the instructions for Use-by date
For professional use only.
purpose of calibration on the detection system, so as to use
establish the metrological traceability of the measurement CE mark with
result of this system. Storage & Stability identification
0123 Manufacturer
Unopened: the validity period is 12 months when stored number of
under 2–8°C and kept away from sunlight. The product can't notified body
Reagents Specification
be stored under frozen conditions. Authorized
Opened: the validity period is 7 days when stored under 2–8 Representative
REF Specification Temperature
°C and kept away from sunlight. The product can't be stored in the
limit
1200301 3 levels ×1 vial ×8 mL European
under frozen conditions.
Community
See packaging label for date of manufacture and expiry date.
Catalogue Date of
Reagents Components number manufacture
Assay Procedure Unique
Level Components Keep away device
Please follow the instructions of this product and the from sunlight
Potassium chloride 0.07-0.09% w/w, ProClin instructions of the applicable instruments. identifier
Level 1
300 0.01%-0.1% w/w. Calibration shall be performed in case of invalid control for Warning Calibrator
instrument or based on a monthly interval. Calibrators with 3
Potassium chloride 3-3.5% w/w, urea 3-3.5%
Level 2 levels must be used for calibration.
w/w, Formazin 180-220 NTU. Zybio Inc.
Before use, leave the calibrator under room temperature for
Potassium chloride 5.5-6% w/w, urea 6.25- 30 minutes. No. 45, Shilin Avenue, Tiaodeng Town, Dadukou
Level 3 District, 400082 Chongqing, PEOPLE'S REPUBLIC
6.75% w/w, Formazin 360-440 NTU. Gently invert it several times to homogenize it.
OF CHINA
This product is of batch specificity, and reagents with different During test: set the instrument at calibration status. Pour the
Web: [Link]
batch No. cannot be mixed. calibrator into a dry and clean test tube. Place the test tube
E-mail: info@[Link]
Traceability: Conductivity can be traced to the standard on the target position for calibration of the instrument. Tel: +86 (0)23 6895 9999
substance of GBW13124, turbidity can be traced to the standard After the calibration is completed, the instrument will display Fax: +86 (0)23 6869 9779
substance of GBW12001, specific gravity can be traced to the in- successful calibration. If the calibration has failed, please
house reference standard. check whether the calibrator is expired and whether the QbD RepS BV
instrument works normally. Groenenborgerlaan 16, 2610 Wilrijk, Belgium
Warnings and Precautions
This product is only applicable to the calibration of Limitations of test methods
conductivity, specific gravity and turbidity module of Zybio This product is used in conjunction with applicable analyzers.
urinalysis system. Please do not use it for other purposes. The acceptable range of quality control products is limited to
The value assignment of calibrators varies with different the models declared in the applicable models. Therefore, only
batches. See bottle label for specific indicated value. the data established by the same method can be compared.
Avoid contact with the skin and eyes. If this product is
splashed into eyes, rinse with running warm water for several
1/2 2/2