TLi Q System User Manual

IMPORTANT: Read the entire manual before operating the TLiIQ® System. Adeza Biomedical Corporation 1240 Elko Drive Sunnyvale, CA 94089-2212 USA TEL: For Technical Support 1-877-945-0208 (USA and Canada) 1-408-745-0975 (Outside of the USA) FAX: 1-408-745-0208

“Authorized Representative” according to IVDD 98/79/ EC

MDSS Burckhardtstrasse 1 30163 Hannover, Germany

2003 Adeza Biomedical Corporation. 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 Adeza Biomedical. The TLiIQ System is covered by U.S. patent numbers 6,267,722 and 6,394,952. The TLiIQ Analyzer is covered by U.S. patent number Des. 434,153. The Cassette Housing is covered by U.S. patent number Des. 432,244. The Adeza logo, TLiIQ, and TLiIQ QCette are registered trademarks of Adeza Biomedical.

Printed in the USA

01188:04

FCC Notice: This equipment has been tested and found to comply with the limits of a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/television technician for help. 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.

TLiIQ System User Manual

iii

CE Notice: This equipment has been tested and found to be in compliance with the following standards per the Low Voltage and EMC Directive: EN61326-1 Electrical Equipment for Measurement, Control and Laboratory Use EN55011 Radiated and Conducted Emissions EN61010-1 Safety Requirements EN61000-3-2 Harmonic Emissions EN61000-3-3 Voltage Fluctuations EN61000-4-2 Electrostatic Discharge EN61000-4-4 Electrical Fast Transients EN61000-4-5 Voltage Surges EN61000-4-6 Conducted Immunity EN61000-4-11 Voltage Interrupts UL Compliant: This equipment has been tested and found to comply with Underwriters Laboratories requirements and has been assigned Control Number 61PK. User modification of this instrument may void such compliance.

TLiIQ System User Manual

iii

TABLE OF CONTENTS Section I Introduction • Intended Use • General Description • Components of the Analyzer • Keypad • Keypad Functions • Keypad Entries • Cassette Insertion Site • Displayed/Printed Results • Specifications • Cautions and Warnings 2

Page 1-1 1-1 1-2 1-3 1-3 1-6 1-11 1-12 1-17 1-20

Installation • General • Environmental Factors • Unpacking • System Setup

TLiIQ System User Manual – Table of Contents

2-1 2-1 2-2 2-4

iv

Section • • • • 3

4

Page 2-5 2-6 2-7 2-8

Getting Started Setting the Date and Time TLiIQ QCette® Setup Factory Default Settings

General Operating/Testing Instructions • Starting the System • Set Calibration • Test Patient • Daily QC • Liquid Controls • Viewing Results On-Screen • Incubation Mode • Internal Mode • External Mode

3.1 3-2 3-4 3-7 3-9 3-12 3-13 3-13 3-14

Software Functions – Detailed Descriptions • Startup Screen • Main Menu

4-1 4-2

TLiIQ System User Manual – Table of Contents

v

Section • • • • • • •

• 5

Page 4-3 4-5 4-10 4-14 4-19 4-19 4-21 4-23 4-24 4-24 4-27 4-28 4-29 4-33

Set Calibration Test Patient Daily QC Liquid Controls Access Data • View/Print Data • Data Transfer View Setup Change Setup • Date/Time • Autoprint • Incubation Mode • TLiIQ QCette® Setup Test Counts

Care of the Analyzer • General Cleaning • Cleaning of Cassette Insertion Site • Cleaning Agents Approved for Use

TLiIQ System User Manual – Table of Contents

5-1 5-1 5-1

vi

Section 6 Printer • Loading Printer Labels • Removing an Empty Label Roll • Clearing Label Jams 7

8

Page 6-1 6-4 6-5

Troubleshooting • General Information • Troubleshooting Table • Error/Invalid Codes

7-1 7-1 7-7

Service and Warranty • Technical Service • Contact Information - Technical Service • Replacement Parts • Contact Information - fFN Customer Service • Warranty

8-1 8-1 8-2 8-2 8-3

TLiIQ System User Manual – Table of Contents

vii

SECTION I – INTRODUCTION For In Vitro Diagnostic Use Only To be used by trained laboratory personnel INTENDED USE The Adeza Biomedical TLiIQ® System is intended to be used in conjunction with the Rapid fFN Cassette, the Rapid fFN Control Kit, and the TLiIQ QCette® for the detection of fetal fibronectin in cervicovaginal secretions. Refer to the directional insert for the Rapid fFN Cassette for detailed intended use information. GENERAL DESCRIPTION The TLiIQ® 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 provides one of three possible patient test results: Positive, Negative, or Invalid. The result is positive if the signal intensity derived from the patient sample is greater than or equal to the reference calibration value specified by the calibration code. The result is negative if the signal intensity derived from the patient sample is less than the reference calibration value specified by the calibration code. The result is reported as invalid if specific internal test criteria have not been met.

TLiIQ System User Manual Section 1 – Introduction

1–1

COMPONENTS OF THE ANALYZER The major components of the analyzer are the display screen, the keypad, and the cassette insertion site. display screen

cassette insertion site

keypad

TLiIQ System User Manual Section 1 – Introduction

1–2

KEYPAD Numeric – Use keypad to enter numerical characters from 0 to 9. Alpha – Use keypad to enter alpha characters from A to Z.

KEYPAD FUNCTIONS (Vertical Scroll) Alpha characters - Use ↑ ↓ to navigate through the alphanumeric keys when selecting an alpha character. Scrolling through Data Records - Use ↑ ↓ when scrolling through data records in ACCESS DATA mode.

TLiIQ System User Manual Section 1 – Introduction

Menu Screens - Some menus require up to three screens to display all of the options. Use ↑ ↓ to go to the next or previous screen of the menu. (Left Arrow Key) 1–3

Previous Page - Use ← to go to the previous page within a data record. Delete - Use DELETE to delete characters to the left of the cursor.

(Right Arrow Key) Next Page - Use → to go to the next page within a data record. Space - Use SPACE to enter a space in the position of the cursor.

TLiIQ System User Manual Section 1 – Introduction

1–4

(Print/Enter Key) Accept/Confirm - Press ENTER to accept or confirm an entry in any data entry field. Print - Press PRINT to print a data record. This print function is only active when a data record is on the display screen.

(Escape Key) Press ESC to return to the most recent Menu screen, unless otherwise specified. If ESC is pressed in any screen requiring data entry, all entries will revert to the previous setting.

TLiIQ System User Manual Section 1 – Introduction

1–5

KEYPAD ENTRIES Entries of numerical characters require pressing the appropriate numeric key. Entries of alpha characters require pressing the numeric key containing the alpha character and the ↑ or ↓ arrows (scroll keys).

TLiIQ System User Manual Section 1 – Introduction

1–6

Example - to enter Cassette Lot Number C9123. 1 - Press 2. Use ↑ arrow until C appears on the display screen. NOTE: The ↑ arrow will scroll repetitively through the characters 2-A-B-C. The ↓ arrow will scroll repetitively through the characters 2-C-B-A. CASSETTE LOT # >2

CASSETTE LOT # >C

ENTER - ACCEPT

ENTER - ACCEPT

2 - Press 9. CASSETTE LOT # >C9 ENTER - ACCEPT

TLiIQ System User Manual Section 1 – Introduction

1–7

3 - Press each subsequent number 1, 2, 3. CASSETTE LOT # >C912_ ENTER - ACCEPT 4 - Press ENTER after all entries have been made. CASSETTE LOT # >C9123 ENTER - ACCEPT

TLiIQ System User Manual Section 1 – Introduction

1–8

Example - to enter Patient Name ABE 1 - Press 2. Use ↑ or ↓ arrow until A appears on the display screen. PATIENT ID >2

PATIENT ID >A

ENTER - ACCEPT

ENTER - ACCEPT

2 - Press 2 again. Use ↑ or ↓ arrow until B appears on the display screen. PATIENT ID >A2

PATIENT ID >AB

ENTER - ACCEPT

TLiIQ System User Manual Section 1 – Introduction

ENTER - ACCEPT

1–9

3 - Press 3 to enter the next letter. Use ↑ or ↓ arrow until E appears on the display screen. PATIENT ID >AB3 ENTER - ACCEPT

PATIENT ID >ABE ENTER - ACCEPT

4 - Press ENTER after all entries have been made.

TLiIQ System User Manual Section 1 – Introduction

1 – 10

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 Rapid fFN Cassette. This area of the instrument should be cleaned regularly (see Section 5).

TLiIQ System User Manual Section 1 – Introduction

1 – 11

DISPLAYED/PRINTED RESULTS Each test result is displayed on the analyzer display screen. A test result requires three screens to display all of the data associated with the result. With AUTOPRINT ON, the test 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 DATA ACCESS mode. Example: Displayed/Printed Results of Calibration Record Displayed

Printed

FETAL FIBRONECTIN 08:00 AM 08/21/01 SYSTEM CALIBRATED USER:XXXXXXXXXXXX→ CAL CODE:FG56 CASSETTE LN:L1002 ANALYZER ID:00426 ESC-MAIN MENU ←

TLiIQ System User Manual Section 1 – Introduction

1 – 12