Response Biomedical RAMP READER Bedienungsanleitung

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OCTOBER 2019

Operator’s Manual, RAMP® Reader i

Table of Contents

1.0 INTRODUCTION ......................................................................................................................... 1

1.1 Overview .................................................................................................................................. 1

1.2 Intended Use ............................................................................................................................ 1

1.3 RAMP® System Description ..................................................................................................... 1

1.4 How the RAMP® System Works ............................................................................................... 3

1.4.1 RAMP® Reader ................................................................................................................. 3

1.4.2 RAMP® Assay/Test Kit Components ................................................................................ 3

1.4.3 Accessories ....................................................................................................................... 3

1.5 Warnings and Precautions ....................................................................................................... 4

1.5.1 Symbols and Definitions ................................................................................................... 4

1.5.2 Summary of Warnings and Precautions ........................................................................... 5

1.6 Unpacking and Installation ....................................................................................................... 6

1.6.1 Unpacking ......................................................................................................................... 6

1.6.2 RAMP® Reader Contents .................................................................................................. 6

1.6.3 Optional Accessories Contents ......................................................................................... 6

1.6.4 Installation ......................................................................................................................... 6

1.6.5 Initial Start-up .................................................................................................................... 7

1.6.6 Optional Accessories ........................................................................................................ 7

2.0 RAMP® SYSTEM OPERATION ................................................................................................ 10

2.1 Keypad Function and Use ...................................................................................................... 10

2.2 RUN/OPTIONS Menu ............................................................................................................ 12

2.3 Using Lot Cards ..................................................................................................................... 12

2.4 Running an Assay .................................................................................................................. 14

2.4.1 Entering User ID ............................................................................................................. 14

2.4.2 Entering User P.I.N. – “User Lock-out” Mode (P.I.N. Enabled) ...................................... 15

2.4.3 Entering Sample ID ......................................................................................................... 15

2.4.4 Inserting a Cartridge ....................................................................................................... 16

2.5 Using the OPTIONS Menu ..................................................................................................... 19

2.5.1 Output Results ................................................................................................................ 19

2.5.2 View Results ................................................................................................................... 22

2.5.3 Run Internal Quality Control (IQC) .................................................................................. 24

2.5.4 Run Liquid Quality Control (LQC) ................................................................................... 25

2.5.5 System Settings .............................................................................................................. 25

2.5.6 Exiting OPTIONS Menu .................................................................................................. 25

2.6 Using the SYSTEM SETTINGS Menu ................................................................................... 26

2.6.1 Accessing the SYSTEM SETTINGS Menu..................................................................... 26

2.6.2 Set Master P.I.N. ............................................................................................................. 27

2.6.3 Setting the System Clock ................................................................................................ 27

2.6.4 Enable User ID/P.I.N....................................................................................................... 28

2.6.5 Edit User ID/P.I.N. ........................................................................................................... 28

2.6.6 Print Settings ................................................................................................................... 29

2.6.7 Transfer Users ................................................................................................................ 31

2.6.8 Erase Memory ................................................................................................................. 32

2.6.9 Set IQC Timer ................................................................................................................. 33

2.6.10 Set LQC Timer ................................................................................................................ 33

2.6.11 Reset LQC Timer ............................................................................................................ 34

2.6.12 Test Counters ................................................................................................................. 35

2.6.13 Connectivity .................................................................................................................... 35

2.6.14 Enable Sound ................................................................................................................. 35

2.6.15 Exit Menu ........................................................................................................................ 36

Operator’s Manual, RAMP® Reader ii

3.0 MAINTENANCE ........................................................................................................................ 37

3.1 Overview ................................................................................................................................ 37

3.2 Cleaning and Decontamination .............................................................................................. 37

3.3 Battery Care ........................................................................................................................... 37

4.0 TROUBLESHOOTING GUIDE .................................................................................................. 38

4.1 Power-On Self-Test Messages / IQC Messages ................................................................... 38

4.2 Lot Card / Barcode Messages................................................................................................ 40

4.3 Transport Messages .............................................................................................................. 41

4.4 Test Run Messages ............................................................................................................... 42

4.5 General Messages ................................................................................................................. 44

5.0 READER SPECIFICATIONS .................................................................................................... 45

APPENDIX A ........................................................................................................................................ 47

Connecting the RAMP® Reader to Accessories ............................................................................... 47

Printer / Computer Connections ........................................................................................................ 47

Reader-to-Reader Connections ........................................................................................................ 47

Barcode Wand Connections ............................................................................................................. 47

APPENDIX B ........................................................................................................................................ 48

User Agreement and Warranty ......................................................................................................... 48

Return Policy ..................................................................................................................................... 48

Receipt of Delivery ............................................................................................................................ 48

Exchange Policy................................................................................................................................ 48

Warranty ............................................................................................................................................ 49

Exclusions ......................................................................................................................................... 49

Liability Limitations ............................................................................................................................ 49

Recall Policy ...................................................................................................................................... 49

End User License Agreement ........................................................................................................... 50

Software Updates.............................................................................................................................. 50

Feedback .......................................................................................................................................... 50

Governing Law .................................................................................................................................. 50

APPENDIX C ........................................................................................................................................ 51

Contact Information ........................................................................................................................... 51

Response Biomedical Customer Service ......................................................................................... 51

European Authorized Representative ............................................................................................... 51

Operator’s Manual, RAMP® Reader 1

1.0 INTRODUCTION

1.1 Overview

The RAMP® System is a rapid, quantitative immunochromatographic system for performing in vitro

diagnostic analyses on a variety of analytes. The System can be used for various applications, from

use in a clinical setting (point-of-care, central or STAT laboratory) to use for onsite screening of

environmental samples.

The System is comprised of the RAMP® Reader (“Reader”) and various RAMP® Assay/Test kits

(“Kits”). Optional accessories include a barcode wand, printer, and cabling required to connect the

Reader to a computer, printer or another Reader. Calibration and expiration information for Kits are

input to the Reader through Lot Cards enclosed with the Kits. The Reader only accepts Kits that are

designed specifically for use with this instrument.

To perform a test, the operator prepares the appropriate sample according to the Test Kit Instructions

for Use, places an aliquot of the sample into the sample well of the Test Cartridge and inserts the

Test Cartridge into the Reader.

Once the Cartridge has been inserted, no further intervention is required. A barcode on the bottom of

the Cartridge is read to determine the Kit lot number. Information loaded with the Lot Card identifies

lot-specific parameters and expiration date. This ensures that an expired Cartridge is not used.

Analysis time is analyte-specific and averages 15 minutes across Assays (Test-dependent). Results

may be viewed on the Reader LCD screen and/or output to a printer or computer. Operator input is

accepted from the Reader’s keypad or an optional barcode wand.

The RAMP® System should only be used by trained personnel.

1.2 Intended Use

The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays

manufactured by Response Biomedical Corp.

1.3 RAMP® System Description

Each disposable, single-use Test Cartridge houses an analyte-specific, immunochromatographic strip

on which the Assay runs. The RAMP® System uses an internal calibrator incorporated into each test

strip to compensate for test-to-test variations.

To perform an assay, the operator transfers a sample into the sample well of a Cartridge and inserts

the Cartridge into the Reader. The sample is drawn by capillary action along the membrane. Analyte

present in the sample interacts and binds with the fluorescently-labeled antibodies forming an

antibody-antigen complex. The complexes and labeled antibodies are subsequently captured at the

detection and control zones. When the reaction in the Cartridge is complete, the Reader scans the

assay strip and detects fluorescence in the detection and the internal standard zones, then by

comparing fluorescence captured at the detection and internal standard zones, converts this ratio

(RAMP® Ratio) into an analyte concentration using lot-specific calibration data. Refer to Test Kit

Introduction

Operator’s Manual, RAMP® Reader 2

Instructions for Uses for more details. The use of the RAMP® Ratio significantly reduces variation

due to sample, operator and membrane differences.

The assay result is displayed on the Reader’s LCD (liquid crystal display) following test development.

The result is stored and can be printed, uploaded to a PC, or deleted.

Lot specific information for each Kit lot is entered using a pre-programmed Lot Card, included with

each Kit. Prior to running assays from a new Kit, the Lot Card is inserted into a slot on the front of the

Reader just below the keypad. The Reader automatically uploads information, including the lot

number, expiration (Use-by) date, and lot-specific parameters for that Kit.

The Reader scans the barcode graphic on the bottom of the Cartridge. This allows the Reader to use

the barcode information to select the lot-specific data stored in the non-volatile memory of the

instrument.

Built-in Internal Quality Control (IQC) performs an automated test of all Reader analytical systems at

start-up and on a scheduled or operator-determined basis to provide a record of proper Reader

functionality.

Introduction

Operator’s Manual, RAMP® Reader 3

1.4 How the RAMP® System Works

1.4.1 RAMP® Reader

The Reader is a scanning fluorometer and data analysis system used for the measurement of

fluorescence in various RAMP® immunoassay applications (Figure 1-1). The Reader can be

operated on battery power or powered via an AC adapter

1.4.2 RAMP® Assay/Test Kit Components

The Kits are used in conjunction with the Reader to detect the concentration of analyte in an aqueous

sample. There are several components associated with the Kits, including a Lot Card and applicable

sample handling supplies. For more information on the Kit, components, operation and sample

handling for the assay, refer to the Test Kit Instructions for Use.

NOTE: The Reader is only designed to be used with Kits manufactured by Response

Biomedical Corporation.

1.4.3 Accessories

There are a number of optional accessories that can be purchased for use with the RAMP® System.

All items are available from Response Biomedical. Please contact your local distributor or Response

Biomedical Customer Service (Appendix C) if you require any of the following accessories

1.4.3.1 Printer

A printer can be connected to the Reader via the RS-232 serial port on the back panel, and is used to

create a hard copy of the assay results. The recommended printer is the Citizen iDP 3110.

1.4.3.2 Barcode Wand

A barcode wand can be connected to the Reader via the back panel and used to enter sample

identification or operator identification into the Reader instead of using the Reader keypad. The

barcode wand is capable of reading UPC, Codabar, EAN, ISBN or similar barcode information.

1.4.3.3 Computer Connections

Detailed instructions for enabling assay results to be output to a computer can be obtained from

Response Biomedical Technical Support.

1.4.3.4 Reader to Reader Cable

By linking Readers together with the appropriate cables, User ID (user identification) and P.I.N.

(personal identification number) information can be transferred to another Reader. Appendix A

provides more details.

Operator’s Manual, RAMP®

Reader

1.5

Warnings and Precautions

1.5.1

Symbols and Definitions

Read all contents of this manual prior to use.

The following symbols are used on the RAMP

the text of this user manual:

WARNING!

Indicates a hazardous situation, which if not avoided, could result in death

or injury, e.g., fire, electrical shock or explosion.

WARNING!

Indicates an electrical shock hazard

CAUTION

Indicates a situation, which if not avoided, could result in damage to the

device.

Manufacturer

In Vitro

diagnostic medical device

Authorized representative in the European Community

Consult operat

 On

(power supply)

 Off

(power supply)

Reader

Warnings and Precautions

Symbols and Definitions

Read all contents of this manual prior to use.

The following symbols are used on the RAMP

® Reader, related components a

nd accessories, or in

WARNING!

Indicates a hazardous situation, which if not avoided, could result in death

or injury, e.g., fire, electrical shock or explosion.

WARNING!

Indicates an electrical shock hazard

CAUTION

Indicates a situation, which if not avoided, could result in damage to the

Manufacturer

diagnostic medical device

Authorized representative in the European Community

Consult operat

ing instructions

(power supply)

Introduction

nd accessories, or in

Indicates a hazardous situation, which if not avoided, could result in death

Indicates a situation, which if not avoided, could result in damage to the

Operator’s Manual, RAMP®

Reader

1.5.2

Summary of Warnings and Precautions

Observe the following precautions when operating the RAMP

1.5.2.1 WARNING!

Reduce the risk associated with hazardous voltage.

Unplug and power off the Reader before cleaning.

Do not immerse the Reader in water.

1.5.2.2 WARNING! R

educe the risk associated with potenti

Do not spill sample on the Reader

biohazard.

If a spill occurs, disinfect external surfaces only using a soft cloth containing a

solution of 0.5% bleach, 70% isopropyl alcohol or 70% ethanol.

Use appropriate precautions in the collection, handling and disposal of specimens,

including diluted specimens and

(Refer to analyte specific package insert for instructions).

Dispose of instrum

ent and accessories in accordance with federal, state, and local

requirements

for potential biohazards.

1.5.2.3

WARNING! Reduce the risk associated with inaccurate results.

Keep movement of the Reader to a minimum while an assay is in process, however sitting

he Reader in an idling or moving vehicle should not inh

1.5.2.4 CAUTION! R

educe the risk of

Do not spill sample

near

contact with electrical components inside the Reader may damage the Reader.

enters the Cartridge

port, power off the device immediately to prevent damage and no not

power on until any spill is dry.

Do not touch the gold contact pads

Store Lot Cards in the anti

Use only Response Biomedical

DO NOT connect the barcode wand to Reader

may result

in damage to the barcode wand

Reader

Summary of Warnings and Precautions

Observe the following precautions when operating the RAMP

® System.

Reduce the risk associated with hazardous voltage.

Unplug and power off the Reader before cleaning.

Do not immerse the Reader in water.

educe the risk associated with potenti

ally infectious patient samples.

Do not spill sample on the Reader

or the outside of a Cartridge

as they become a po

If a spill occurs, disinfect external surfaces only using a soft cloth containing a

solution of 0.5% bleach, 70% isopropyl alcohol or 70% ethanol.

Use appropriate precautions in the collection, handling and disposal of specimens,

including diluted specimens and

Test Kit contents

as these items are potential biohazards

(Refer to analyte specific package insert for instructions).

ent and accessories in accordance with federal, state, and local

for potential biohazards.

WARNING! Reduce the risk associated with inaccurate results.

Keep movement of the Reader to a minimum while an assay is in process, however sitting

he Reader in an idling or moving vehicle should not inh

ibit the development of a test.

educe the risk of

instrument or accessory damage.

near

the Reader Cartridge port

or on the outside of a

contact with electrical components inside the Reader may damage the Reader.

port, power off the device immediately to prevent damage and no not

power on until any spill is dry.

Do not touch the gold contact pads

on the Lot Cards.

Store Lot Cards in the anti

-static pouches provided.

Use only Response Biomedical

supplied or recommended accessories with the Reader.

DO NOT connect the barcode wand to Reader

while

the Reader is turned ON.

in damage to the barcode wand

Introduction

ally infectious patient samples.

as they become a po

tential

If a spill occurs, disinfect external surfaces only using a soft cloth containing a

Use appropriate precautions in the collection, handling and disposal of specimens,

as these items are potential biohazards

ent and accessories in accordance with federal, state, and local

Keep movement of the Reader to a minimum while an assay is in process, however sitting

ibit the development of a test.

or on the outside of a

Cartridge. Liquid

contact with electrical components inside the Reader may damage the Reader.

If a spill

port, power off the device immediately to prevent damage and no not

supplied or recommended accessories with the Reader.

the Reader is turned ON.

Doing so

Introduction

Operator’s Manual, RAMP® Reader 6

1.6 Unpacking and Installation

1.6.1 Unpacking

The Reader and/or optional accessories are packed in a cushioned container for maximum protection

during shipment. If the shipping container is damaged, inspect the Reader as it is unpacked. If the

Reader is damaged, notify the carrier and your distributor, or Response Biomedical Corporation to

arrange for immediate repair or replacement. Retain the shipping container and all packaging

material for repackaging.

To unpack the Reader, remove the packaging and carefully lift out the Reader. Place the Reader on

a dry, clean, level surface. Remove the AC Adapter and Power Cord and check the label to confirm

country-specific voltage requirements. Remove remaining contents and compare with the packing

slip or list below. If any of the contents are missing, contact your distributor or Response Biomedical

Corporation Customer Service (Appendix C).

1.6.2 RAMP® Reader Contents

Quantity Instrument

1 RAMP® Reader

1 Reader AC Adapter with adaptable plug

(region-specific)

1 Reader Operator’s Manual

1.6.3 Optional Accessories Contents

Quantity Optional Accessories

1 Printer (with associated accessories)

1 Barcode Wand

1 Computer Connection Cable

1 Reader-to-Reader Cable

1.6.4 Installation

The Reader should be plugged in prior to use in order to charge the battery. Connect the AC Adapter

to the Input Port on the back panel of the Reader (Figure 1-2) and plug into an AC outlet. It requires

24 hours to fully charge the battery but it can be used for testing while it is charging.

NOTE: Do not connect or disconnect the Reader from an AC outlet while a test is in

progress.

WARNING! Only use the charger provided with your RAMP® Reader.

Operator’s Manual, RAMP®

Reader

1.6.5 Initial Start-up

The power button is located on the back panel of the Reader (Figure

on, the Reader performs a Power

certain pre-

set parameters. The POST includes calibration verification, optical system verification,

real-

time clock test, transport movement test, and a bat

battery at the time of the POST). If the measured battery voltage is low, a warning message appears

on the LCD along with an audible alarm. If this occurs, the Reader should be plugged into an AC

outlet using t

he supplied Adapter.

NOTE: A fully-

charged battery will allow approximately 100 tests to be run before re

charging is required. In the event that a Reader is

low. It takes approximately 24 hours to fully rechar

may be operated with the AC Adapter during battery recharging. Refer to Section

recommended battery care.

NOTE: Ensure

that the battery is sufficiently charged or that the Reader is connected to an

AC outlet prior to performing a test.

outlet once the test has started

The Reader can also function in an enhanced control

function. This requires the setting of a Master P.I.N., which provides controlled access to the

SYSTEM SETTINGS Menu.

Functions available through the SYSTEM SETTINGS Menu include

changing the instrument clock, s

operator data, erasing data, selecting print settings, test counters, erasing memory, and setting QC

timers. The User Lock-

out mode ensures that only operators with a valid controlled P.I.N

to run tests on the Reader.

To operate the Reader with User Lock

by setting a Master P.I.N. (Section

(Section 2.6.4).

NOTE: Ensure that

operators have read and understood the Operator’s Manu

Test Kit Instructions for Use

1.6.6

Optional Accessories

If using a printer, connect it to the Reader via the RS

See Appendix A

for printer compatibility information.

If the Reader is connected to a computer or another Reader, ensure that the serial connect

properly secured. See

Appendix A

CAUTION!

If using the optional Barcode Wand accessory, ensure that it is properly

connected to the Reader via the Barcode Wand connector port on the

turning the Reader on. Failure to do so may result in damage to the Barcode Wand.

Reader

The power button is located on the back panel of the Reader (Figure

1-2

). When the power is turn

on, the Reader performs a Power

-On Self-

Test (“POST”) to ensure the system is operating within

set parameters. The POST includes calibration verification, optical system verification,

time clock test, transport movement test, and a bat

tery test (if the Reader is operating on the

battery at the time of the POST). If the measured battery voltage is low, a warning message appears

on the LCD along with an audible alarm. If this occurs, the Reader should be plugged into an AC

he supplied Adapter.

charged battery will allow approximately 100 tests to be run before re

charging is required. In the event that a Reader is

left

on for 24 hours, the battery may run

low. It takes approximately 24 hours to fully rechar

ge the battery, however, the Reader

may be operated with the AC Adapter during battery recharging. Refer to Section

recommended battery care.

that the battery is sufficiently charged or that the Reader is connected to an

AC outlet prior to performing a test.

Do not connect or disconnect the Reader from an AC

outlet once the test has started

The Reader can also function in an enhanced control

led

manner by enabling the “User Lock

function. This requires the setting of a Master P.I.N., which provides controlled access to the

Functions available through the SYSTEM SETTINGS Menu include

changing the instrument clock, s

etting and enabling User IDs and associated P.I.N.s, transferring

operator data, erasing data, selecting print settings, test counters, erasing memory, and setting QC

out mode ensures that only operators with a valid controlled P.I.N

To operate the Reader with User Lock

out, ensure the SYSTEM SETTINGS Menu has limited access

by setting a Master P.I.N. (Section

2.6.2

) and that a User ID and P.I.N. are defined for each operator

operators have read and understood the Operator’s Manu

Test Kit Instructions for Use

before attempting to perform a test.

Optional Accessories

If using a printer, connect it to the Reader via the RS

232 serial port on the back panel (Figure

for printer compatibility information.

If the Reader is connected to a computer or another Reader, ensure that the serial connect

Appendix A

for serial port compatibility information.

If using the optional Barcode Wand accessory, ensure that it is properly

connected to the Reader via the Barcode Wand connector port on the

back panel PRIOR to

turning the Reader on. Failure to do so may result in damage to the Barcode Wand.

Introduction

). When the power is turn

Test (“POST”) to ensure the system is operating within

set parameters. The POST includes calibration verification, optical system verification,

tery test (if the Reader is operating on the

battery at the time of the POST). If the measured battery voltage is low, a warning message appears

on the LCD along with an audible alarm. If this occurs, the Reader should be plugged into an AC

charged battery will allow approximately 100 tests to be run before re

on for 24 hours, the battery may run

ge the battery, however, the Reader

may be operated with the AC Adapter during battery recharging. Refer to Section

3.3 for

that the battery is sufficiently charged or that the Reader is connected to an

Do not connect or disconnect the Reader from an AC

manner by enabling the “User Lock

-out”

function. This requires the setting of a Master P.I.N., which provides controlled access to the

Functions available through the SYSTEM SETTINGS Menu include

etting and enabling User IDs and associated P.I.N.s, transferring

operator data, erasing data, selecting print settings, test counters, erasing memory, and setting QC

out mode ensures that only operators with a valid controlled P.I.N

. are allowed

out, ensure the SYSTEM SETTINGS Menu has limited access

) and that a User ID and P.I.N. are defined for each operator

operators have read and understood the Operator’s Manu

al and the

232 serial port on the back panel (Figure

1-2).

If the Reader is connected to a computer or another Reader, ensure that the serial connect

ion is

If using the optional Barcode Wand accessory, ensure that it is properly

back panel PRIOR to

turning the Reader on. Failure to do so may result in damage to the Barcode Wand.

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