Autoclave Validation System

OM-CP-AVS150-CERT and OM-CP-AVS150-5-CERT

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Enables compliance with
FDA 21 CFR Part 11
Software Calculates Thermal
Resistance in F0
NIST Traceable Calibration Included
Stand Alone, Complete System
No Thermocouple Wires
Digital Calibration Through Software

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The OM-CP-AVS150 Series series has been discontinued. Please see the OM-CP-AVS140-6 as a possible alternative or contact our Sales Department. You can also check on the availability of any remaining stock.

The OM-CP-AVS150 is a complete system used to perform autoclave validations. The OM-CP-AVS150 consists of a NIST traceable OM-CP-HITEMP-150 data logger, an IP68 extended range thermal shield, an OM-CP-IFC200 USB cable package and FDA 21 CFR part 11 secure software. For larger size autoclaves or mapping projects, the OM-CP-AVS150-5, includes five OM-CP-HITEMP-150’s and five thermal shields. The OM-CP-HITEMP-150 is completely submersible and can measure temperatures up to 150°C (302°F). The 51 mm (2") rigid probe provides a fast response time and can record readings as fast as once per second. The OM-CP-HITEMP-150 can be used in each autoclave cycle for verification and to provide data for validation. When used with the thermal shield the device can withstand up to 250°C (482°F) (time dependent).

The secure software provides data in graphical and tabular form, and provides a summary and statistical report of the data. The software also features sterilization calculations to determine the F0 value. Furthermore the software allows for different user levels and logins, electronic signatures, an audit trail and a secure data file to stand up to auditors.

This device can be started and stopped directly from a computer and their compact design allows them to fit almost anywhere. Data retrieval is simple. Plug the device into an available USB port and our easy-to-use software does the rest. The software converts a PC into a real-time strip chart recorder. Data can be printed in graphical and tabular format or exported to a text or Microsoft Excel file.

SPECIFICATIONS
OM-CP-HITEMP-150
DATA LOGGER
Temperature Sensor: 100Ω platinum RTD
Temperature Range: -40 to 150ºC (-40 to 212ºF)
Temperature Resolution: 0.05ºC
Calibrated Accuracy: ±0.5ºC
Start Modes: Software Programmable
• Start now
• Delay start
Memory: 32,767 readings
Reading Rate: One second up to 12 hours
Calibration: Digital calibration through software
Calibration Date: Automatically recorded within device
Battery Type: 3.9V high-temperature lithium battery (included); factory replaceable only
Battery Life: 1 year typical (1 minute reading rate @25ºC)
Data Format: Date and time stamped ºC, ºF, K, ºR
Time Accuracy: ±1 minute/month at 20ºC (RS232 cable not in use)
Computer Interface: PC serial or USB (interface cable required); 2400 baud
Software: Windows XP SP3/Vista/7 and 8 (32-bit and 64-bit)
Operating Environment: -40 to 150ºC (-40 to 302°F), 0 to 100% RH
Dimensions:
  Body: 28 x 45 mm dia. (1.1 x 1.75")
  Probe: 50 x 5 mm dia. (2.0 x 3/16")
Weight:
  OM-CP-HITEMP-150: 225 g (8 oz)
  OM-CP-AVS150: 1.72 kg (3.8 lb)
  OM-CP-AVS150-5: 3.81 kg (8.4 lb)
Material: 316 stainless steel

Specifications
(Thermal Shield)
Operating Envionment: -200 to 250°C (-328 to 482°F) time limited, see table on PDF
IP Rating: IP68
Dimensions: 53.3 H x 66 mm dia (2.1 X 2.6")
Weight: 0.3 kg (0.65 lb)
Material: Teflon

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产品描述

OM-CP-AVS150-CERT

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Includes (1) OM-CP-HITEMP-150 data logger with NIST calibration certificate, an extended range thermal shield, OM-CP-IFC200 interface cable, FDA 21 CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols

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注: Comes complete with 3.9V high temperature lithium battery, NIST calibration certificate, operator’s manual, secure software, and OM-CP-IFC200 interface cable.