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Electronic Temperature Indicator "Termotest Prima" for Cold Chain Monitoring
Manufacturer:
LLC "NPP "CHISTY INSTRUMENT"
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Description
Medical product Thermoindicator electronic for cold chain control "Termotest Prima" according to TU 9452-004-62672773-2016 (hereinafter - "Termotest Prima") is designed: - to control compliance of the controlled object with the directive (set by the Customer and established in the process of production) temperature interval (hereinafter - "NORMA" interval); - to detect and unambiguously establish in the process of control the facts of violations of the "NORMA" interval (hereinafter - violations) with their differentiation by temperature and time parameters in the directive (set by the Customer and established in the process of production) temperature-time intervals of violations (hereinafter - TVIN); - to visually display in the process of control the results of the temperature and time intervals of violations (hereinafter - TVIN). Service life of Thermotest Prima/2; Thermotest Prima/2 bis versions is not less than 2 years.
Specifications
Type of product according to PP RF 616
Medical devices, including surgical, other, not included in other groupings
Classification by safety requirements must comply with the requirements of GOST R 50444, GOST IEC 61010-1, in accordance with GO
class III
Service life after activation
2 year
Thermotest is used
during storage and transportation of thermolabile preparations at all four levels of the cold chain
Classification depending on perceived mechanical effects according to GOST R 50444
group 5
Classification depending on the potential risk of use according to GOST R 31508 and according to the order of the Ministry of He
Class 1
Shelf life before activation
24
Weight
20 year
Length
SBVVBG mm
Width
32 mm
Height
13 mm
Polling frequency of the monitored temperature
one reading per 0.5 or 1 min (2; 1 unit/min)
Display of control results
Liquid crystal display
Number of NORMA temperature intervals in the operating temperature range
one
Minimum value of the "NORM" interval
3 °C
Maximum value of the NORM interval
110 °C
Error of setting the temperature limits of the "NORMA" interval
0.5 °C
Minimum value of temperature and time interval of violations by temperature parameter
2.5 °C
Maximum value of temperature and time interval of violations by parameter by parameter of temperature
107 °C
Error of setting the temperature limits of the temperature and time interval of violations
Not more than ±0.5 ºC °C
Minimum value of temperature-time interval of violations by time parameter
30
Maximum value of temperature-time interval of violations by time parameter
99
Time reference measurement error
± 0,001% %
Number of set temperature and time intervals of violations in Thermotest in the operating temperature range
0...6
Total number of violations downward from the "NORM" interval
31
Total number of upward violations from the "NORM" interval
31
Probability of failure-free operation of Thermotest
Not less than 0.97; at a confidence level of 0.8
Note: All specifications are provided by the manufacturer and may be subject to change. Please contact us to confirm the latest specifications before placing your order.
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