Critical Diagnostics ASPECT Reader User manual

Page 1

ASPECT Reader™

User Guide - English

AW201127 Rev. 1

UG0001 - EN

2 ASPECT Reader User Guide

Before You Begin

Several important sources of information are available to help get you started and to refer to as needed to ensure accurate test results. Before

using this system, read this entire User Guide and the package insert that comes with the ASPECT-PLUS™ST2 corresponding test. Take special note

of throughout this User Guide.

Important Safety Instructions

F Follow proper infection control guidelines for handling all blood samples and anything that comes in contact with blood.

FAll parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed

cleaning and disinfection.

FUsers should adhere to standard precautions when handling or using this device. For more information, refer to

“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007”,

http: www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html

ASPECT Reader SERIAL NUMBER:

Distributor to Call When Ordering Supplies

NAME:

CONTACT INFORMATION:

To reorder supplies, contact your Critical Diagnostics distributor:

Product Name Part Number Description

ASPECT-PLUS ST2 Test PLUS0001 ST2 Test Cassettes (20 cassettes)

ASPECT Reader READ0001 Complete reader system

ASPECT Reader Paper PAP0001 Paper roll for ASPECT Reader (5 rolls)

ST2 Controls LQC0001 ST2 liquid quality controls, high and low (2 high, 2 low)

Electronic Quality Control EQC0001 ASPECT Reader EQC cassette (1 cassette)

ASPECT Reader User Guide 3

User Guide Overview

INTRODUCTION contains a brief description of the features and theory of operation of the ASPECT Reader. It also contains some basic information

about interface controls such as keyboard keys and data entry elds and their use in the software.

INSTALLATION contains information about the unpacking and set up, as well as specications and warranty information about the reader.

INITIAL SET-UP contains information about setting up general reader settings, LIS and Network settings, as well as setting up user access rights

and viewing and/or printing error logs.

OPERATION contains detailed information about running samples on the ASPECT Reader and menu items found under the Operator icon.

REVIEW DATA contains information about reviewing patient results, as well as viewing liquid and electronic quality control results. Information

about printing results and sending patient results, liquid and electronic quality control results to a LIS system is contained in this chapter.

CONTROLS contains information about setting up and running controls.

MAINTENANCE contains information about routine maintenance of the ASPECT Reader.

TROUBLESHOOTING contains information about troubleshooting the reader.

4 ASPECT Reader User Guide

TABLE OF CONTENTS

INTRODUCTION................................................................................................................................................................. 6

Welcome ............................................................................................................................................................................ 6

System Overview................................................................................................................................................................ 6

Intended Use.......................................................................................................................................................6

Principles of Measurement...................................................................................................................................6

Data Entry Fields .................................................................................................................................................6

System Speciﬁcations Table ..................................................................................................................................7

Warnings, Precautions, Limitations .......................................................................................................................7

Symbols ..............................................................................................................................................................8-10

INSTALLATION................................................................................................................................................................... 10

Reader............................................................................................................................................................................... 11

Accessories ......................................................................................................................................................................... 11

Installation......................................................................................................................................................................... 12-13

INITIAL SET-UP.................................................................................................................................................................. 13

Main Menu......................................................................................................................................................................... 13

General Reader Settings...................................................................................................................................................... 14

Language........................................................................................................................................................................... 14

Default Settings.................................................................................................................................................................. 15

Time and Time Format...................................................................................................................................................... 15-16

Date and Date Format ...................................................................................................................................................... 16

QC Settings....................................................................................................................................................................... 16-17

Time-out Set-up................................................................................................................................................................ 17

Test Mode........................................................................................................................................................................... 17

LIS Settings ........................................................................................................................................................................ 18

Network Settings ................................................................................................................................................................ 18-19

Printer Settings................................................................................................................................................................... 19

Manage Users..................................................................................................................................................................... 20

Edit User .......................................................................................................................................................................... 21

Delete Selected User......................................................................................................................................................... 21

Add User.......................................................................................................................................................................... 22

OPERATION....................................................................................................................................................................... 22

Log In ................................................................................................................................................................................ 22-23

Running a Sample .............................................................................................................................................................. 23-24

Cassette Preparation........................................................................................................................................................... 24

Removing Cassette.............................................................................................................................................................. 25

Printing Results................................................................................................................................................................... 25

Transmitting Results............................................................................................................................................................ 25

REVIEW DATA AND ERROR LOG........................................................................................................................................ 26

Review Patient Results by Date............................................................................................................................................ 26-27

Show Details Option.......................................................................................................................................................... 27

Print List Option................................................................................................................................................................ 28

Review Patient Results by Sequence #.................................................................................................................................. 28

Show Details Option.......................................................................................................................................................... 29

Print List Option................................................................................................................................................................ 29-30

Review Patient Results by Patient ID.................................................................................................................................... 30

Show Details Option.......................................................................................................................................................... 31

Print List Option................................................................................................................................................................ 31

ASPECT Reader User Guide 5

Review Patient Results by Operator ID................................................................................................................................. 32

Show Details Option.......................................................................................................................................................... 32-33

Print List Option................................................................................................................................................................ 33

Review Liquid QC (LQC) Results........................................................................................................................................... 33

Show Details Option.......................................................................................................................................................... 34

Print List Option................................................................................................................................................................ 35

Review Electronic QC (EQC) Results...................................................................................................................................... 35-36

Show Details Option.......................................................................................................................................................... 36

Print List Option................................................................................................................................................................ 36-37

Send Results to LIS.............................................................................................................................................................. 37-38

View Error Log.................................................................................................................................................................... 38

Instrument Errors Log ....................................................................................................................................................... 38-39

Handling Errors Log.......................................................................................................................................................... 39

CONTROLS ........................................................................................................................................................................ 39

Liquid Quality Controls (LQC) .............................................................................................................................................. 40-41

Printing LQC Results.......................................................................................................................................................... 41

Electronic Quality Control (EQC)........................................................................................................................................... 42-43

Printing EQC Results.......................................................................................................................................................... 43-44

UPDATING READER........................................................................................................................................................... 44

Update............................................................................................................................................................................... 44

Update Firmware.............................................................................................................................................................. 44-45

EXPORT LOGS ................................................................................................................................................................... 45

Patient Results.................................................................................................................................................................... 45-46

Liquid QC Results................................................................................................................................................................ 46

EQC Results ........................................................................................................................................................................ 46

Users.................................................................................................................................................................................. 46-47

Raw Scans.......................................................................................................................................................................... 47

MAINTENANCE.................................................................................................................................................................. 47

System Shipping and Storage.............................................................................................................................................. 47

Recommended Maintenance and Cleaning ........................................................................................................................... 47

Main Housing of the Reader.............................................................................................................................................. 48

Cassette Drawer................................................................................................................................................................ 48

Replacing the Paper Roll..................................................................................................................................................... 48-49

Battery Power .................................................................................................................................................................... 49

Changing Batteries ........................................................................................................................................................... 49

System Decontamination..................................................................................................................................................... 49-50

Long Term Shutdown......................................................................................................................................................... 50

TROUBLESHOOTING ......................................................................................................................................................... 51

Troubleshooting and Error Codes ......................................................................................................................................... 51

WARRANTY ....................................................................................................................................................................... 52

6 ASPECT Reader User Guide

INTRODUCTION

Welcome

Congratulations on the decision to test with the ASPECT Reader System by Critical Diagnostics. This user guide will provide useful information on

performing tests with this system.

System Overview

The ASPECT Reader System is a semi-automated bench- top reader intended for use with cassette-based immunouorescent in-vitro diagnostic

assays. Utilizing the principles of rapid lateral ow immunoassay technology, samples are analyzed using a test cassette. The test cassette

contains a Radio Frequency ID (RFID) tag that identies parameters such as test name, calibration coefcients, expiry date, Sample/Reagent

Assembly (SRA) type. After the test cassette is loaded with a specimen it is inserted into the reader. An internal scanner reads the RFID tag and

automatically processes the test. Internal software interprets and reports the test results which are displayed on the screen, where they can be

printed and/or electronically exported.

Test specic information is stored on the RFID tag. No upload of any test-related information is required prior to performing a test.

Intended Use

The ASPECT Reader is a benchtop instrument intended to be used with cassette-based immunouorescent in vitro diagnostic assays manufactured

by Critical Diagnostics. The ASPECT Reader is used in the professional laboratory environment.

After the patient sample has been added to the Test cassette, the cassette is placed inside of the ASPECT Reader to be analyzed. The ASPECT

Reader will scan the test strip and measure the uorescent signal by processing the results using method-specic algorithms. The ASPECT Reader

will display the test results.

Refer to assay-specic package insert for details on specic tests.

Principles of Measurement

The ASPECT Reader detects a uorescent-label (TF5: Excitation 650nm; Emission 670nm) in a lateral ow immunoassay (LFI) test format. A

pre-determined amount of test specimen is pipetted into the sample well of the test cassette. A buffer solution is pipetted into the second well.

The test cassette (called cartridge in the software) is then immediately inserted into the ASPECT Reader for analysis. The reader assembly excites

the uorescent label area of the test cassette then measures the uorescent signal to generate a quantitative result when processed through the

calibration curve algorithm. The analyte result is displayed on the screen where it can be printed and/or exported to a LIS system.

Data Entry Fields

Data entry elds are areas in a screen in which information is entered. One screen can have several data entry elds, but only one eld can

be selected and active for entering data at a time. Pressing a numeric key will input that character into the data entry eld. If the number of

characters in a eld is exceeded, no additional characters may be entered unless others have been deleted.

To select a data entry eld, move the cursor via the [↑] or [↓] keys to move up and down in the screen. To move back and forth between left

and right text elds, use the [→] or [←] keys. The content of the eld is highlighted to show it is selected or active.

To delete characters from a data eld, select the eld using the reader’s [↑] or [↓] keys, then press the [⇐] Delete key at the bottom of the

numeric keys. The last character in the eld will be deleted.

~ ~

ASPECT Reader User Guide 7

System Specications Table

Power Requirements 100 - 240 VAC, 47- 63Hz, self-switching (U.S./International), 0.9-0.34 Amps max

Replaceable Batteries 4x LR6-AA + 6V— 4.16 A

Ambient Operating Temperature 15 – 30° C / 59 – 86° F

Ambient Operating Humidity Range 30 – 80% R.H. (non-condensing)

Shipping & Storage Temperature -20 – 55 °C

Shipping & Storage Humidity 30 – 80% R.H. (non-condensing)

Keypad Numeric

Display 3.5 inch diagonal

Weight 3 lb. (6.6 kg)

Width 6.3 in. (~16 cm)

Depth 9.5 in. (~24cm)

Height 3.9 in. (~10cm)

Radio Frequency (RF) Operating Frequency 13.56 MHz

RF Output Power 200 mW

The ASPECT Reader meets the relevant EC harmonized standards for safety: IEC 61010-1, EN 61010-2-101, CSA 61010-1-04, EN61326-1:2002,

EN61326-2-6:2006.

FCC ID:YMQ-8048000 This device complies with Part 15 of the FCC rules. Operation is subject to the following conditions:

1. The device may not cause harmful interference.

2. This device must accept any interference received, including interference that may cause undesired operation.

3. Changes or modications not expressly approved by the party responsible for compliance could void the user’s authority to operate the

equipment.

Warnings, Precautions, Limitations

Before using this system, read this entire User Guide and the Instructions For Use for the speciﬁc test being performed on the ASPECT Reader.

• For in vitro diagnostic use.

• For use by healthcare professional.

• Results should be interpreted along with clinical ﬁndings and other laboratory test results.

• Individuals assigned to operate this reader must be properly trained and fully aware of the potential hazards when using the ASPECT Reader

prior to use.

• Do not place the ASPECT Reader in water.

• Do not drop or throw the reader.

• Operate the reader on a dry, level surface.

• Do not move the reader while a test is in process.

• Plug the reader into a grounded power source.

• The ASPECT Reader was tested and has passed all declared EMC compliance standards. However, the use of ancillary equipment may

electromagnetically interfere with this reader. Take precautionary measures to minimize electromagnetic interference where possible.

• Always follow universal precautions when handling patient samples. Wear the proper personal protective equipment such as: lab coats, non-

powdered disposable gloves, safety glasses, etc. when working with the ASPECT Reader and patient samples.

• Use of new non-powdered disposable gloves will reduce the risk of cross contamination when handling patient samples.

• All samples, controls, etc. should be treated as though they are infectious.

• Dispose of unused reagents and waste in accordance with Country, Federal, Provincial, State and local regulations.

• Clean all work surfaces before and after testing.

• The ASPECT Reader has been designed to work as a system. Performance characteristics have not been established for use of the system with

other supplies or equipment.

• Please note that the infected medical equipment must be disposed of as medical biohazard waste and may not be included in used electronic

equipment disposal or recycling program.

8 ASPECT Reader User Guide

The following symbols are used in this guide:

Symbol Meaning

The term WARNING is used to inform you about situations or conditions that could result in personal injury.

The term CAUTION is used to inform you about situations or conditions that could result in damage to the ASPECT

Reader or related components.

Indicates warnings that are not related directly to personal injury hazards, but concern the proper use of the ASPECT

Reader or related components.

NOTE Presents information that will permit accurate measurement through correct use of the ASPECT Reader, as well as

other useful information.

Environmental

Symbol Meaning

Operating Speciﬁcations:

• Temperature: 15°C–30°C

• Humidity: 30% to 80% Relative Humidity, Non-condensing

• Altitude: 0–2000 m

• Degree of pollution: 2

To ensure proper operating temperature, do not place the ASPECT Reader near radiators, bright sunlight, heat

registers, stoves and/or other heat-producing equipment.

Electrical Warnings

Symbol Meaning

Operate the ASPECT Reader using only the power cord and power supply (AC adaptor). The ASPECT Reader should only

be connected to an earth-grounded outlet with:

• 100–240 VAC

• 47–63 Hz

• 0.9-0.34 A

The ASPECT Reader is intended for indoor use only. To reduce the risk of electric shock, always unplug the power

supply from the AC power source following use

ASPECT Reader User Guide 9

Date Management

Symbol Meaning

The printout is the formal record of the test result. Print out every test result and make 2 photocopies. Place the

printed test results and both photocopies in the subject’s Case Report Form (CRF) binder.

Results stored in the ASPECT Reader memory are for temporary back-up purposes only, and may be overwritten. The

ASPECT Reader memory stores results for the last 100 tests run. Once memory capacity has been reached, the most

recent test result automatically overwrites the oldest test result.

Disposal Information

Symbol Meaning

FBiohazard Warning

Handle and dispose of Test Cassettes in accordance with standard biohazard practices, unless otherwise indicated in the

relevant package insert.

Laser Device Caution

Symbol Meaning

Do not remove external panels to access the interior of the ASPECT Reader. The ASPECT Reader contains a UV LED used

to read the Test Cartridges. UV LED’s are not considered to be hazardous when used for their intended purpose.

Biohazard Warning

Symbol Meaning

FWhen using the ASPECT Reader, observe universal precautions for safety, laboratory working practices, and follow

laboratory operating procedures regarding personal protective equipment (lab coats, gloves, etc.) and safety.

10 ASPECT Reader User Guide

Symbols

Symbols that may be associated with the ASPECT Reader:

Symbol Meaning

CCE Mark

DDo not re-use

VIn Vitro Diagnostic device

MManufacturer

hCatalog Number

gBatch Code

rTemperature Limitation

PAuthorized Representative

iConsult instructions for use

Printer Paper

wProtect from any light source

pProtect from moisture

INSTALLATION

1. Position the shipping container upright and open the top aps.

2. Open the cardboard box inside the shipping container.

NOTE: If using a utility knife, extend the blade to an appropriate length to avoid cutting any internal components.

3. Lift out the top cardboard spacer. The side boxes of this spacer contain the:

• power cord

• adaptor plugs for US and ex-US power

• power adaptor

• paper roll

• four (4) LR6-AA batteries (1.5V)

4. Lift the next cardboard spacer from the box.

5. Remove the reader by slowly lifting it vertically out of the shipping container.

6. Place the reader on a stable surface. The reader is contained in a sealed plastic bag containing a desiccant pouch. Remove the reader from

the plastic bag.

7. Replace all packing materials in the shipping container for storage.

8. Check the contents of the box (Figure 8-1) with the shipping list shown below:

• ASPECT Reader

• External power supply

• Power cord

• Power Supply Adaptors (US, EU)

• ASPECT Reader User Guide

• 1 roll of thermal paper

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