User Manual
113 Pages
Preview
Page 1
User Manual
IMPORTANT: Read the entire manual before operating the PeriLynx™ System Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Tel: For Technical Support (USA and Canada) 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 Fax: 1-508-263-2967 Tel: For Technical Support (Outside the USA and Canada)
Hologic Ltd. Heron House, Oaks Business Park, Crewe Road, Wythenshawe, Manchester, M23 9HZ, UK +44 (0)161 946 2206
Asia
+852 3526 0718
Netherlands:
0800 0226782
Australia:
+61 2 9888 8000
Norway:
800 15564
Austria:
0800 291919
Portugal:
800 841034
Belgium:
0800 77378
Spain:
900 994197
Denmark:
8088 1378
South Africa:
0800 980 731
Finland:
0800 114829
Sweden:
020 797943
France:
0800 913659
Switzerland:
0800 298921
Germany:
0800 1830227
UK:
0800 0323318
Ireland (Rep):
1 800 554144
Rest of the world:
00800.800.29892
Italy:
800 786308
Intl Fax number:
0041.21.633.39.10
©2016 Hologic, Inc. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means in whole or in part without the prior written permission of Hologic, Inc. This product may be covered by one or more U.S. patents identified at http://hologic.com/patentinformation. Hologic, PeriLynx, Rapid fFN, and QCette are trademarks and/or registered trademarks of Hologic, Inc. and/ or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks and product names are the property of their respective owners. English
i
AW-14693-001 Rev. 001 4-2016
TABLE OF CONTENTS Section
Page
Section 1 - Introduction
1-1
Intended Use
1-1
General Description
1-1
Components of the Analyzer Touch screen Cassette insertion site
1-2 1-2 1-2
Displayed/Printed Results
1-3
Specifications
1-4
Cautions and Warnings
1-6
Disposal of Electrical & Electronic Equipment
1-10
Symbols Used on the Instrument
1-12
PeriLynx™ System User Manual Table of Contents
ii
TABLE OF CONTENTS Section
Page
Section 2 - Installation
2-1
General
2-1
Environmental Factors
2-1
Unpacking
2-2
System Setup
2-5
Getting Started
2-7
Setting the Date and Time
2-9
Factory Default Settings
2-10
Shutdown
2-11
Extended Shutdown
2-11
PeriLynx™ System User Manual Table of Contents
iii
TABLE OF CONTENTS Section
Page
Section 3 - General Operating/Testing Instructions
3-1
Starting the System
3-1
Overview of PeriLynx Analyzer Main Menu
3-2
Typical Menu Item Sequences
3-3
Using the Touch Screen
3-4
Run QCette QC - Quick Reference
3-8
Test Patient - Quick Reference
3-9
Enter New Calibration Code - Quick Reference
3-11
Run Liquid QC - Quick Reference
3-12
Section 4 - Software Functions - Detailed Descriptions
4-1
Startup Screen
4-1
Main Menu
4-2
Enter New Calibration Code
4-3
Test Patient
4-6
PeriLynx™ System User Manual Table of Contents
iv
TABLE OF CONTENTS Section
Page
Run QCette QC
4-15
Liquid Controls
4-20
Adjust Settings Adjust Settings - Date/Time Adjust Settings - Sound Settings Adjust Settings - Auto Print Adjust Settings - Password Settings Adjust Settings - QCette Setup Adjust Settings - Update Software
4-28 4-28 4-30 4-31 4-32 4-35 4-41
View Reports
4-42
Monthly Usage
4-42
Test Counts
4-44
Access Data Access Data - View/Print Data Access Data - Data Transfer
4-45 4-45 4-47
PeriLynx™ System User Manual Table of Contents
v
TABLE OF CONTENTS Section
Page
Section 5 - Care of the Analyzer
5-1
Section 6 - Printer Loading Printer Labels
6-1 6-1
Removing an Empty Label Roll
6-4
Clearing Label Jams
6-5
Section 7 - Troubleshooting
7-1
General Information
7-1
Error/Invalid Codes
7-10
Section 8 - Service
8-1
Technical Support
8-1
Replacement Parts
8-3
PeriLynx™ System User Manual Table of Contents
vi
Section 1 - Introduction For In Vitro Diagnostic Use Only To be used by trained medical personnel
Intended Use The Hologic PeriLynx™ system is an in vitro diagnostic device intended to be used in conjunction with the Rapid fFN® 10Q cassette, the Rapid fFN® control kit, and the PeriLynx™ QCette® for the detection of fetal fibronectin (fFN) in cervicovaginal secretions. Refer to the directional insert for the Rapid fFN 10Q cassette for detailed intended use information. General Description The PeriLynx™ analyzer is an electronic optical reflectance device that converts a colorimetric reaction from a cassette into a digitized format. The data are analyzed using multiple parameters, including a comparison of sample data to calibration data. The analyzer reports the fFN concentration in the clinical specimen. The analyzer reports fFN concentrations ranging from 0–500 ng/mL. Concentrations greater than 500 ng/mL are reported as >500 ng/mL. The result is reported as invalid if specific internal test criteria have not been met.
PeriLynx™ System User Manual Section 1 - Introduction
1-1
Components of the Analyzer The major components of the analyzer are the touch screen and the cassette insertion site. Touch screen Use the touch screen to enter data, select options, and move through the menus. See Section 3 - General Operating/Testing Instructions, for a full description of using the touch screen. Cassette insertion site The Cassette Insertion Site contains a slightly concave trough designed to capture any fluids that may have been spilled while applying sample to the cassette. This area of the instrument should be cleaned regularly (see Section 5 - Care of the Analyzer). Note:
PeriLynx™ System User Manual Section 1 - Introduction
For the detection of fetal fibronectin (fFN) in cervicovaginal secretions, insert a Rapid fFN 10Q Cassette or PeriLynx QCette only. 1-2
Displayed/Printed Results Each menu function result is displayed on the analyzer touch screen. With Auto Print ON, the result is automatically printed. Each printed result requires one printer label. Results can be printed from any data record screen either immediately after a test or in Access Data mode. The example below demonstrates the display and printout of a patient test. Example: Displayed/Printed Results of Patient Test
Displayed PeriLynx™ System User Manual Section 1 - Introduction
Printed 1-3
Specifications Power Supply Memory Capacity
UL +24 VDC listed power supply 50 Calibration Records 50 QCette Records 50 Control Records
Touch screen
1000 Patient Records 5-inch diagonal display with 480 x 800 resolution and
Dimensions
256 colors. Resistive interface. Length - 10 inches (25.4 cm) Width - 7.5 inches (19.05 cm) Height - 4 inches (10.16 cm)
Operating Temperature
Weight - 2.4 pounds (1090 g) 15° to 30°C
Operating Humidity
59° to 86°F 20% to 80%, non-condensing
PeriLynx™ System User Manual Section 1 - Introduction
1-4
Sound level, analyzer
A.C. Supply
Maximum A-weighted sound pressure level at the typical user’s position and at a radius of 1 meter around the analyzer is 56 dB. 100-240VAC 50-60 Hz
Input Connector Output Connectors
2.1A Coaxial power plug with positive center conductor 9-pin RS-232 connector 3 host USB connectors Ethernet connector Printer power connector
PeriLynx™ System User Manual Section 1 - Introduction
1-5
Cautions and Warnings There are no known hazards associated with the PeriLynx system when it is operated in accordance with the instructions in this manual. However, you should be aware of situations that can result in serious injury. WARNING! Ensure that the analyzer power adapter is connected to an AC electrical outlet that provides voltage and current specified by Hologic. Use of an incompatible power receptacle can cause shock and fire hazard. CAUTION! Use only the power adapter supplied by Hologic. Use of an incompatible power adapter can damage the internal components. CAUTION! Always turn off the power and unplug the power adapter before cleaning the exterior of the analyzer. Fluid can damage internal components. DO NOT clean the power adapter. CAUTION! Extreme heat can damage the display and other electronic components.
PeriLynx™ System User Manual Section 1 - Introduction
1-6
WARNING! Never apply cleaning reagents by spray as the liquid may leak into the analyzer causing damage to the electrical components or possibly electrical shock to the user. CAUTION! Do not immerse the analyzer in liquid. Fluid can damage internal components. CAUTION! Do not clean the touch screen display with undiluted bleach solution or other solvents. Caustic cleaning solutions can damage the touch screen. CAUTION! Use appropriate laboratory procedures for handling biohazardous materials. If this equipment is used in a manner not specified by the manufacturer, then the protection provided by the equipment may be impaired. FCC Notice: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
PeriLynx™ System User Manual Section 1 - Introduction
1-7
FCC Warning: Changes or modification not expressly approved by the manufacturer responsible for compliance could void the user’s authority to operate the equipment. Note: The use of a non-shielded interface cable with this equipment is prohibited. CE Notice: This equipment has been tested and found to be in compliance with the following standards per the IVD Directive: EN61326-2-6 EN61010-2-101
Electrical Equipment for Measurement, Control and Laboratory Use; EMC Requirements; In Vitro Diagnostic (IVD) Medical Equipment. Electrical Equipment for Measurement, Control and Laboratory Use; Part 101; Particular requirements for In Vitro Diagnostic (IVD) Medical Equipment. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic environment should be evaluated prior to operation of the device. Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
PeriLynx™ System User Manual Section 1 - Introduction
1-8
This equipment also complies with the following safety standards: UL61010-1
Safety Requirements for Electrical Equipment for Laboratory Use Part 1: General Requirements, with an ETL or equivalent Approval Mark
ICES-003
Industry Canada Regulation: Interference-Causing Equipment Standards - Digital Apparatus
CAN/CSA C22.2 No. 61010-2-101 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 1: General Requirements, with ETL or equivalent Approval Mark
PeriLynx™ System User Manual Section 1 - Introduction
1-9
Disposal of Electrical & Electronic Equipment Waste Electrical and Electronic Equipment (WEEE) Hologic is dedicated to meeting country specific requirements associated with the environmentally sound treatment of our products. Our objective is to reduce the waste arising from our electrical and electronic equipment. Hologic realizes the benefits of subjecting such WEEE equipment to potential reuse, treatment, recycling or recovery to minimize the amount of hazardous substances entering the environment. Your responsibility As a Hologic customer, you are responsible for ensuring that devices marked with the symbol shown below are not placed into the municipal waste system unless authorized to do so by the authorities in your area. Please contact Hologic (see below) prior to disposing any electrical equipment provided by Hologic. Symbol used on the instrument The following symbol is used on this instrument:
Do not dispose in municipal waste. Contact Hologic (see below) for information regarding proper disposal.
Reclamation Hologic will provide for the collection and proper reclamation of electrical devices we provide to our customers. Hologic strives to reuse Hologic devices, subassemblies, and components whenever possible. When reuse is not appropriate, Hologic will ensure the waste material is properly disposed of. PeriLynx™ System User Manual Section 1 - Introduction
1-10
Hologic Contact Information Corporate Headquarters
Authorized Representative in the European Community
PeriLynx™ System User Manual Section 1 - Introduction
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Tel: (USA and Canada) 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 1-508-263-2900 Fax: 1-508-263-2967 Hologic Ltd. Heron House, Oaks Business Park Crewe Road, Wythenshawe Manchester, M23 9HZ, UK Tel: +44 (0)161 946 2206
1-11
Symbols Used on the Instrument The following symbols may appear on this instrument or its packaging: Caution, consult instructions for use
Manufacturer
Waste Electrical and Electronic Equipment - contact Hologic for disposal of the instrument.
Authorized Representative in the European Community
Catalogue Number
30˚C 15˚C
Store between 15°C and 30°C
Serial Number
Biological risks
For in vitro diagnostic testing
Direct current (DC)
PeriLynx™ System User Manual Section 1 - Introduction
1-12
Section 2 - Installation General This section provides detailed installation instructions for the PeriLynx system. Follow installation steps carefully to insure proper installation and operation. Environmental Factors The PeriLynx system has been designed to be safe under the following conditions: • Indoor use; • Altitudes up to 2000 m; • Maximum relative humidity of 80% for temperatures up to 30°C; • Pollution Degree II, in accordance with IEC 61010-1 Category II. The PeriLynx system is for use only in an office or a clean laboratory environment. • The operating temperature should be held relatively constant. The optimum operating temperature is 15° to 30°C (59° to 86°F). Before operating, allow the instrument to equilibrate to room temperature. Place the instrument away from direct sunlight and away from locations subject to extreme temperature variations (e.g., near open windows, ovens, hot plates, radiators, etc.).
PeriLynx™ System User Manual Section 2 - Installation
2-1