Omega | OM-CP-AVS140-6 | Owner Manual | Omega OM-CP-AVS140-6 Owner Manual

Omega OM-CP-AVS140-6 Owner Manual
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OM-CP-AVS140-6
Autoclave
Validation
Data
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INSTRUCTION
SHEET
Logging System
MQS5775/0117
M0000/0016
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OM-CP-AVS140-6
Autoclave Validation System
The OM-CP-AVS140-6 is a complete system used to perform autoclave validations. The OM-CP-AVS140-6
consists of five high temperature (OM-CP-HITEMP140) and one pressure data logger (OM-CP-PR140), an OMCP-IFC406 Multiplexer Interface and the OMEGASOFT Secure Software providing tools to users to assist with
FDA 21 CFR Part 11 compliance.
Hardware
OM-CP-HITEMP140 Product Overview
High Temperature Data Logger
The OM-CP-HITEMP140 data logger is Omega’s solution for high precision, rugged temperature monitoring. It
can withstand temperatures from -40 °C to 140 °C and has an accuracy of ±0.1 °C.
The OM-CP-HITEMP140 can store up to 32,700 readings, and features a rigid external probe capable of
measuring extended temperatures, up to 260 °C (500 °F). Custom probe lengths up to 7 inches are available.
Also available, is the OM-CP-HITEMP140-PT that features a 24 inch flexible stainless steel probe for measuring
extended temperatures up to 350 °C (662 °F). The probe is durable and can be spiraled, bent or angled in any
direction, making it easy to log temperatures within bottles, vials or other hard to reach places.
OM-CP-HITEMP140 Specifications
Description
OM-CP-HITEMP140
Temperature Sensor:
100 Ω Platinum RTD
OM-CP-HITEMP140:
-200 °C to +260 °C (-328 °F to +500 °F)
Probe Measurement Range:
OM-CP-HITEMP140-PT:
-200 °C to +350 °C (-328 °F to + 662 °F)
Temperature Resolution:
Calibrated Accuracy:
Reading Rate:
Memory:
Battery Life
Time Accuracy:
Operating Environment:
Dimensions (Body):
Submersible:
Weight:
Material:
Approvals:
0.01 °C (0.02 °F)
±0.1 °C/±0.18 °F
(20 °C to +140 °C/68 °F to +284 °F)
±0.3 °C/±0.54 °F
(-20 °C to +19.99 °C/-4 °F to +67.98 °F)
±0.4 °C/±0.72 °F
(-40 °C to -20.01 °C/-40 °F to -4.02 °F)
1 second up to once every 24 hours
32,700 readings
1 Year Typical
(1 Minute reading rate at 25 °C/77 °F)
±1 minute/month at 20 °C to 30 °C
(68 °F to 86 °F) (Stand alone mode)
-40 °C to +140 °C (-40 °F to +284 °F),
0 %RH to 100 %RH
1.6 in x 0.970 in dia. (40 mm x 24.6 mm
dia.)
Yes (IP68)
4.2 oz (120 g)
316 Stainless Steel
CE
OM-CP-AVS140-6
Hardware
OM-CP-PR140 Product Overview
Pressure Data Logger
The OM-CP-PR140 is a data logger designed to validate if appropriate
pressure levels have been achieved during the steam sterilization cycle. It
is built with a precision stainless steel pressure gauge, the data logger has
an accuracy of ±0.03 Bar (±0.435 PSI), which can be achieved over a wide
temperature range, from 20 °C to +140 °C (68 °F to 284 °F). The OM-CPPR140 is available in either a Flush Top or NPT Pressure Port Top design,
with an optional female luer fitting accessory.
OM-CP-PR140 Specifications
Description OM-CP-PR140
Pressure Sensor:
Semiconductor (Strain Gauge)
Pressure Range: 0 to 5 Bar (0 to 72.5 PSIA)
Description OM-CP-PR140
Time Accuracy:
Operating Environment:
Pressure Resolution: 0.1m Bar (0.0015 PSIA)
Calibrated Accu- ±0.03 Bar (± 0.435 PSI)
racy: (20 °C to +140 °C/68 °F to 284 °F)
Response Time:
0.1 ms (10 %FSR to 90 %FSR)
±1 minutes/month at 20 °C
-20 °C to +140 °C (-4 °F to +284 °F), 0 %RH to
100 %RH
Note: The OM-CP-PR140 may be used above 60
°C for up to 8 hours, per 24 hour period.
Dimensions:
2.3 in x 1.0 in dia. (58.2 mm x 25.4 mm dia.)
Submersible:
Yes (IP68)
Weight:
Reading Rate: 1 second up to once every 24 hours
Material:
Memory: 32,700 readings
3 oz (85 g)
Stainless Steel
Approvals: CE
Flush Top
NPT Pressure Port Top
Luer Fitting
OM-CP-AVS140-6
Hardware
OM-CP-IFC406 Product Overview
Multiplexer Data Logger Interface
The OM-CP-IFC406 Multiplexer Data Logger Interface
allows for multiple devices to be connected into one
interface. Each OM-CP-IFC406 allows for 6 data loggers
to be connected. Up to 3 OM-CP-IFC406 units may be
daisy-chained together to communicate with a total of 18
devices through 1 USB port. To connect multiple OM-CPIFC406 Interfaces together, simply join the units side by
side, making sure the spring pin contacts are connected
and magnetically joined.
OM-CP-IFC406 Specifications
Description
Operating Environment:
Connection Type:
Weight:
Material:
Dimensions:
Maximum Input Voltage:
Approval:
Battery:
OM-CP-IFC406
+10 °C to +35 °C; 0 %RH to 95 %RH non-condensing
LED Indicators
USB (to PC)
Blue: Indicates unit has power.
Amber: Channel is busy or searching for a device
Green: Operation successful or complete
1.65 lb (750 g)
6061 Aluminum (PTFE impregnated hard anodized
coating),
ABS Plastic
9.5 in x 1.95 in x 1.75 in (241.3 mm x 49.5 mm x 44.5
mm)
6 Volts (V)
Dust Cover
Be sure to remove the dust cover
from the spring pin contacts to
ensure the devices communicate
properly.
CE
This device does not use a battery
To connect multiple OM-CP-IFC406 Interfaces together, simply join the
units side by side, making sure the spring pin contacts are connected
and magnetically joined. And optional AC Power adapter is included,
recommended for three or more daisy-chained OM-CP-IFC406
Interfaces.
OM-CP-AVS140-6
Software
OMEGASOFT Secure Software
The OMEGASOFT Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software
ensures standards in which electronic files are considered equivalent to paper records, saving time and effort.
OMEGASOFT Secure Software contains criteria such as electronic signatures, access codes, secure data files, and
an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity.
OM-CP-AVS140-6
IQ/OQ/PQ
IQ/OQ/PQ Validation Protocol
Meeting compliance with regulations for the FDAs Good Manufacturing Practices, or those set forth in Quality
Plans, has become increasingly complex. Omega has simplified this process by including IQ/OQ/PQ protocols
with its Omega Secure Software package.
This enormous time and money saving feature eliminates the need to develop in-house software validation
procedures. The Omega IQ/OQ/PQ protocol is in support of FDA and cGMP guidelines. In addition, Omega
offers a Software Validation Workbook to help the user verify the functionality of the software.
Installation Qualification (IQ)
• A description of the OMEGASOFT system
• Verification that all OMEGASOFT system equipment, software
and accessories are received in good condition
• A check for complete documentation
• Verification that the installation of Omega equipment is
completed properly
• Verification that OMEGASOFT Secure Software is installed
properly on the target workstation
• Verification of basic communication between Omega data
logger(s) and the target workstation(s)
Operational Qualification (OQ)
• Functional verification of Omega data loggers
• Handling and maintenance information for the use of Omega
equipment
• Omega operating procedures for primary functions
• Verification of proper communication between the Omega data
logger(s) and the workstation(s)
• Verification that the data logger hardware is operational
Performance Qualification (PQ) Recommendation
• Additional handling precautions for maintaining the accuracy of
Omega equipment
• Periodic maintenance information for the use of Omega equipment
• Periodic calibration verification in the field
• Comparison of the reported values to a known good standard
• Verification of acceptable performance in the target system
omega.com info@omega.com
U.S.A.
Headquarters:
Servicing North America:
Omega Engineering, Inc.
Toll-Free: 1-800-826-6342 (USA & Canada only)
Customer Service: 1-800-622-2378 (USA & Canada only)
Engineering Service: 1-800-872-9436 (USA & Canada only)
Tel: (203) 359-1660
Fax: (203) 359-7700
e-mail: info@omega.com
For Other Locations Visit omega.com/worldwide
The information contained in this document is believed to be correct, but OMEGA accepts no liability for any errors it contains, and reserves the
right to alter specifications without notice.
WARRANTY/DISCLAIMER
OMEGA ENGINEERING, INC. warrants this unit to be free of defects in materials and workmanship for a period of 13 months
from date of purchase. OMEGA’s WARRANTY adds an additional one (1) month grace period to the normal one (1) year product
warranty to cover handling and shipping time. This ensures that OMEGA’s customers receive maximum coverage on each product.
If the unit malfunctions, it must be returned to the factory for evaluation. OMEGA’s Customer Service Department will issue an
Authorized Return (AR) number immediately upon phone or written request. Upon examination by OMEGA, if the unit is found
to be defective, it will be repaired or replaced at no charge. OMEGA’s WARRANTY does not apply to defects resulting from
any action of the purchaser, including but not limited to mishandling, improper interfacing, operation outside of design limits,
improper repair, or unauthorized modification. This WARRANTY is VOID if the unit shows evidence of having been tampered with
or shows evidence of having been damaged as a result of excessive corrosion; or current, heat, moisture or vibration; improper
specification; misapplication; misuse or other operating conditions outside of OMEGA’s control. Components in which wear is not
warranted, include but are not limited to contact points, fuses, and triacs.
OMEGA is pleased to offer suggestions on the use of its various products. However, OMEGA neither assumes
responsibility for any omissions or errors nor assumes liability for any damages that result from the use of its
products in accordance with information provided by OMEGA, either verbal or written. OMEGA warrants only
that the parts manufactured by the company will be as specified and free of defects. OMEGA MAKES NO OTHER
WARRANTIES OR REPRESENTATIONS OF ANY KIND WHATSOEVER, EXPRESSED OR IMPLIED, EXCEPT THAT OF
TITLE, AND ALL IMPLIED WARRANTIES INCLUDING ANY WARRANTY OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE ARE HEREBY DISCLAIMED. LIMITATION OF LIABILITY: The remedies of purchaser set forth
herein are exclusive, and the total liability of OMEGA with respect to this order, whether based on contract, warranty,
negligence, indemnification, strict liability or otherwise, shall not exceed the purchase price of the component upon
which liability is based. In no event shall OMEGA be liable for consequential, incidental or special damages.
CONDITIONS: Equipment sold by OMEGA is not intended to be used, nor shall it be used: (1) as a “Basic Component” under 10
CFR 21 (NRC), used in or with any nuclear installation or activity; or (2) in medical applications or used on humans. Should any
Product(s) be used in or with any nuclear installation or activity, medical application, used on humans, or misused in any way,
OMEGA assumes no responsibility as set forth in our basic WARRANTY / DISCLAIMER language, and, additionally, purchaser will
indemnify OMEGA and hold OMEGA harmless from any liability or damage whatsoever arising out of the use of the Product(s) in
such a manner.
RETURN REQUESTS / INQUIRIES
Direct all warranty and repair requests/inquiries to the OMEGA Customer Service Department. BEFORE RETURNING ANY
PRODUCT(S) TO OMEGA, PURCHASER MUST OBTAIN AN AUTHORIZED RETURN (AR) NUMBER FROM OMEGA’S CUSTOMER
SERVICE DEPARTMENT (IN ORDER TO AVOID PROCESSING DELAYS). The assigned AR number should then be marked on the
outside of the return package and on any correspondence.
The purchaser is responsible for shipping charges, freight, insurance and proper packaging to prevent breakage in transit.
FOR WARRANTY RETURNS, please have the following
information available BEFORE contacting OMEGA:
1. Purchase Order number under which the product was
PURCHASED,
2. Model and serial number of the product under warranty, and
3. Repair instructions and/or specific problems relative to the
product.
FOR NON-WARRANTY REPAIRS, consult OMEGA for current
repair charges. Have the following information available BEFORE
contacting OMEGA:
1. Purchase Order number to cover the COST of the repair,
2. Model and serial number of the product, and
3. Repair instructions and/or specific problems relative to the
product.
OMEGA’s policy is to make running changes, not model changes, whenever an improvement is possible. This affords our customers the latest in technology and
engineering. OMEGA is a registered trademark of OMEGA ENGINEERING, INC.
© Copyright 2016 OMEGA ENGINEERING, INC. All rights reserved. This document may not be copied, photocopied, reproduced, translated, or reduced to any electronic
medium or machine-readable form, in whole or in part, without the prior written consent of OMEGA ENGINEERING, INC.
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