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Thermoindicator electronic for cold chain control
Manufacturer:
LLC "NPP "CHISTY INSTRUMENT"
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Description
Medical product Thermoindicator electronic for cold chain control "Thermotest Prima" according to TU 9452-004-62672773-2016 (hereinafter - "Thermotest 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/3; Thermotest Prima/3 bis versions is not less than 3 years.
- 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/3; Thermotest Prima/3 bis versions is not less than 3 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
Probability of failure-free operation of Thermotest
Not less than 0.97; at a confidence level of 0.8
Total number of upward violations from the "NORM" interval
31
Total number of violations downward from the "NORM" interval
31
Number of set temperature and time intervals of violations in Thermotest in the operating temperature range
0...6
Time reference measurement error
± 0,001% %
Maximum value of temperature-time interval of violations by time parameter
99
Minimum value of temperature-time interval of violations by time parameter
30
Error of setting the temperature limits of the temperature and time interval of violations
Not more than ±0.5 ºC °C
Maximum value of temperature and time interval of violations by parameter by parameter of temperature
107 °C
Minimum value of temperature and time interval of violations by temperature parameter
2.5 °C
Error of setting the temperature limits of the "NORMA" interval
0.5 °C
Maximum value of the NORM interval
110 °C
Minimum value of the "NORM" interval
3 °C
Number of NORMA temperature intervals in the operating temperature range
one
Display of control results
Liquid crystal display
Polling frequency of the monitored temperature
one reading per 0.5 or 1 min (2; 1 unit/min)
Height
13 mm
Width
32 mm
Length
SBVVBG mm
Weight
20 year
Service life after activation
3 year
Shelf life before activation
24
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
Classification depending on perceived mechanical effects according to GOST R 50444
group 5
Thermotest is used
during storage and transportation of thermolabile preparations at all four levels of the cold chain
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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