Response Biomedical RAMP 200 User manual

Tel: [phone] (toll free) Tel: [phone]-
6119 (int’l) Email:
[e-mail]
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6010 (int’l) Email:
[e-mail]

© 2016 Response Biomedical Corp.
2017-08 | V 1.8 | English
C2100-1.8
This manual is for users of the RAMP®200 instrument firmware versions 1.2 and higher.
Every effort is made to ensure that all the information contained in this manual is correct at the time of printing.
However, Response Biomedical Corp. reserves the right to make any changes necessary without notice as part of
ongoing product development.
Any customer modification to the instrument will render the warranty or service agreement null and void.
RAMP is a registered trademark of Response Biomedical Corp.
Microsoft is a registered trademark of Microsoft Corp.
Microsoft Windows is a registered trademark of Microsoft Corp.
Microsoft Excel is a registered trademark of Microsoft Corp.
Zebra is a registered trademark of ZIH Corp.
Symbol is a registered trademark of Motorola, Inc.
Response Biomedical Corp. 1781 - 75 Avenue W. Vancouver, BC Canada V6P 6P2
Toll free 1.888.591.5577 (North America only)
Tel [phone] (International)
Fax [phone]
Web www.responsebio.com
Response 24-hour Technical Support
Toll free 1.866.525.7267 (North America only)
Tel [phone] (International)
E-mail [e-mail]
EMERGO EUROPE, Prinsessegracht 20 2514 AP - The Hague - The Netherlands

i
RAMP®200 USER MANUAL....................................................................................................... i
EDITION NOTICE........................................................................................................................ i
TRADEMARKS............................................................................................................................ i
CORPORATE INFORMATION .................................................................................................... i
TECHNICAL ASSISTANCE......................................................................................................... i
EUROPEAN REPRESENTATIVE INFORMATION..................................................................... i
INTRODUCTION...................................................................................................5
Scope and Audience...................................................................................................................6
How to Use This Manual.............................................................................................................6
Customer Information .................................................................................................................6
Customer Training .................................................................................................................6
Customer Service ..................................................................................................................6
Ordering Information..............................................................................................................6
Conventions Used in This Manual..............................................................................................7
Symbols .................................................................................................................................7
Abbreviations .........................................................................................................................8
Overview.....................................................................................................................................9
Immunoassay Measurement Principle........................................................................................9
Result Interpretation..................................................................................................................10
RAMP®200 - components........................................................................................................10
RAMP® 200 Control Module (CM) ......................................................................................10
RAMP® 200 Test Module (TM) ...........................................................................................10
Power Supply and Interconnect Cable ................................................................................10
USB Flash Drive ..................................................................................................................10
WARNINGS & PRECAUTIONS..........................................................................11
User/Operator Qualification ......................................................................................................12
Summary of Warnings and Precautions ...................................................................................12
UNPACKING & SETUP......................................................................................13
Unpacking and Setup................................................................................................................14
Shipping container contents......................................................................................................14
Optional Components ...............................................................................................................15
Setup.........................................................................................................................................16
RAMP®200 BASICS ..........................................................................................19
RAMP®200 Basics ...................................................................................................................20
Powering On/Off........................................................................................................................20
Touchscreen .............................................................................................................................21
Display Icons.............................................................................................................................21
Test Port Identification ..............................................................................................................22
PERFORMING A RAMP®TEST.........................................................................23
Using Lot Cards ........................................................................................................................24

ii
Starting an Assay......................................................................................................................25
QUALITY CONTROL..........................................................................................29
Running LQC ............................................................................................................................30
LQC Icons.................................................................................................................................33
Running IQC .............................................................................................................................34
WORKING WITH RESULTS...............................................................................35
Data Management Guidelines ..................................................................................................36
Viewing Saved Assay Results ..................................................................................................36
Viewing Event Logs ..................................................................................................................37
Searching for Assay Results.....................................................................................................38
Searching for Events.................................................................................................................39
Manually Transferring / Printing Results or Logs......................................................................40
Converting Exported Data to Excel Format ..............................................................................41
MANAGING SETTINGS .....................................................................................42
Accessing the Settings Menu....................................................................................................44
View Settings ............................................................................................................................44
Edit Settings..............................................................................................................................45
Restoring Defaults ....................................................................................................................46
Managing Operators .................................................................................................................46
Importing Files...........................................................................................................................49
Exporting Files ..........................................................................................................................50
Deleting Assay Results.............................................................................................................51
EDITING SETTINGS...........................................................................................53
Editing Settings Using the Reader Configuration Utility (RCU) ................................................54
Installing the RCU.....................................................................................................................54
How the RCU works..................................................................................................................54
Getting Started with the RCU....................................................................................................55
Changing the Default Login ......................................................................................................55
Resetting the Password in an Emergency................................................................................56
Restoring the Supervisor Operator ID/Password......................................................................56
Accessing Configuration Files...................................................................................................57
Setting up Communications Between RCU and Readers ........................................................58
Identifying Readers Through the RCU......................................................................................59
MAINTENANCE..................................................................................................60
Maintenance..............................................................................................................................61
Maintenance Guidelines ...........................................................................................................61
Upgrading Device Software ......................................................................................................61
Exterior Cleaning.......................................................................................................................62
Waste Electrical and Electronic Equipment (WEEE)................................................................62
TROUBLESHOOTING........................................................................................63
Troubleshooting ........................................................................................................................64
General .....................................................................................................................................64
Power-on Self Test Message / IQC Messages.........................................................................64
Test Run Messages..................................................................................................................65

iii
Lot Card ....................................................................................................................................66
Settings Messages....................................................................................................................67
LQC Related Messages............................................................................................................68
Warnings and Confirmation Requests......................................................................................68
Printer Errors.............................................................................................................................69
Communications Errors ............................................................................................................69
USB Device Errors....................................................................................................................70
SPECIFICATIONS..............................................................................................71
Specifications............................................................................................................................72
TM Specifications......................................................................................................................72
CM Specifications .....................................................................................................................72
TM / CM Specifications.............................................................................................................73
Settings: View Screen Tabs .............................................................................74
Assay Tab.................................................................................................................................74
Sample/Patient ID................................................................................................................74
New Assay Lockout .............................................................................................................74
Predefined Notes .................................................................................................................74
LQC Tab....................................................................................................................................75
Control ID.............................................................................................................................75
Timer Tab..................................................................................................................................75
Timer Intervals .....................................................................................................................76
Printer Tab ................................................................................................................................76
Auto Print .............................................................................................................................76
Print Headers.......................................................................................................................77
Login Tab..................................................................................................................................77
Device Name .......................................................................................................................77
Lockout ................................................................................................................................77
Login Requirements.............................................................................................................77
Privilege Requirements........................................................................................................77
File Tab.....................................................................................................................................78
Network Settings..................................................................................................................78
File Locations.......................................................................................................................78
About Tab..................................................................................................................................78
Settings: Edit Screen Tabs...............................................................................79
Timer Tab..................................................................................................................................79
IQC Interval (minutes)..........................................................................................................79
Menu Idle Timeout (minutes)...............................................................................................79
File Tab.....................................................................................................................................80
Tab Guidelines.....................................................................................................................80
Date/Time Tab ..........................................................................................................................80
Tab Guidelines.....................................................................................................................80
Language Tab...........................................................................................................................81
Tab Guidelines.....................................................................................................................81
Misc. Tab...................................................................................................................................81
Network Transfer Mode .......................................................................................................81
Sound...................................................................................................................................82

iv
IP Tab........................................................................................................................................82
Tab Procedure .....................................................................................................................82
IP Mode................................................................................................................................82
USER AGREEMENT & WARRANTY.................................................................83
User Agreement and Warranty.........................................................................84
Return Policy.............................................................................................................................84
Receipt of Delivery....................................................................................................................84
Exchange Policy........................................................................................................................84
Warranty....................................................................................................................................84
Exclusions.................................................................................................................................85
Liability Limitations....................................................................................................................85
Recall Policy..............................................................................................................................85
End User License Agreement...................................................................................................85
Software Updates......................................................................................................................86
Feedback ..................................................................................................................................86
Governing Law..........................................................................................................................86

A

Thank you for selecting the RAMP® 200 Platform, the rapid immunochromatographic system for
performing in vitro diagnostic analyses.
This manual is intended for operators of the RAMP® 200 and describes procedures available to users
with access rights up to supervisor level. Information specific to service procedures is not contained in
this publication.
This manual is divided into the following parts:
Part A –Introduction: Contains an overview of the user manual and describes basic features and
functions of the RAMP® 200.
Part B –Warnings & Precautions: Contains important information about safe operation of the
RAMP® 200.
Part C –Unpacking and Setup: Contains information about the RAMP®200 delivery, packaging
and setup.
Part D –RAMP® 200 Basics: Contains information about the RAMP® 200 modules and startup
procedures.
Part E –Performing a RAMP® Test: Contains information about running an assay on the RAMP®
200.
Part F –Quality Control: Contains information about the RAMP® 200 QC procedures.
Part G –Working with Results: Contains information about the assay result handling on the
RAMP® 200.
Part H –Managing Settings: Contains general information about instrument, connectivity and
user administration settings for the RAMP® 200.
Part I –Editing Settings: Contains detailed information about instrument, connectivity and user
administration settings for the RAMP® 200.
Part J –Maintenance: Contains all necessary information concerning instrument maintenance
and cleaning.
Part K –Troubleshooting: Contains helpful information about troubleshooting.
Part L –Specifications: Contains information about technical data of the RAMP® 200.
Part M –Index: Contains an index to find information in the manual by keyword search.
Contact your local sales representative for any questions or information regarding RAMP® 200 training.
Contact your local sales representative for further information regarding the RAMP® 200 warranty.
Replacement parts and consumable materials should be ordered from Response Biomedical Corp. When
ordering, please use the Response Biomedical catalog number and reference name for each item. For
more information, contact Response Customer Service at: 1.866.525.7267.

Visual cues are used to help locate and interpret information in this manual quickly. This section explains
formatting conventions used in this manual.
►
Procedural step
Use-by/Expiry date
●
List item
Caution, consult accompanying
documents.
Indicates a situation which, if not avoided,
could damage device.
Cross reference, consult manual
Electrical Hazard
Fragile, handle with care
Warning!
Indicates a hazard which, if not avoided,
could result in death or injury (i.e. fire,
electrical shock or explosion).
Keep away from rain
Consult Instructions for Use
Do not re-use
In vitro diagnostic device
Do not use if package is damaged
Contains sufficient for <n> Tests
Temperature limitation
Waste electrical and electronic
equipment (WEEE)
Do not dispose of this product in municipal
waste. Contact Response Technical Support
for disposal or recycling information.
Reference/Catalogue number
Manufacturer
Lot/Batch code
Authorized Representative in
the European Community
Contents of Kit
Conformité Européenne
CE Mark. Product meets the safety
requirements of the European Union

Abbreviation
Description
CFR
Code of Federal Regulations
CM
Control Module
CSA
Canadian Standards Association
DHCP
Dynamic Host Configuration Protocol
FCC
Federal Communications Commission
FTP
File Transfer Protocol
FTPS
File Transfer Protocol Over Secure Socket Layer
HID
Human Interface Device
HRB
High Running Background
HTTP
Hypertext Transfer Protocol
HTTPS
Hypertext Transfer Protocol Over Secure Socket Layer
IEC
International Electrical Commission
IFU
Instructions for Use
IP
Internet Protocol
IQC
Internal Quality Control
LED
Light Emitting Diode
LQC
Liquid Quality Control
MAC
Machine Address Control
NTP
Network Time Protocol
RCU
Reader Configuration Utility
RoHS
Restriction of Hazardous Substances
SN
Serial Number
SSL
Secure Socket Layer
TCP/IP
Transmission Control Protocol/Internet Protocol
TM
Test Module
UL
Underwriters Laboratories Inc.
USB
Universal Serial Bus
VGA
Video Graphics Array
WEEE
Waste Electrical and Electronic Equipment

The RAMP® 200 is a system comprised of two primary components:
A Test Module (TM) that analyzes sample tests.
A Control Module (CM) that manages the sample test results that it receives from the TM.
Calibration and expiration information for Test Cartridges are uploaded to the CM through Lot Cards
that are included with the Test Kits.
To perform a Test, add a sample into the well of a Test Cartridge and then insert the Test Cartridge into
the TM. Once the Test Cartridge has been inserted, no further intervention is required. A barcode on the
bottom of the Test Cartridge is then read by the RAMP® 200 to determine the lot number. Information
loaded with the Lot Card identifies lot-specific parameters and expiration date. This ensures that an
expired cartridge cannot be used.
Analysis time is analyte-specific and typically takes approximately 15 minutes per sample. Analysis
results may be viewed on the RAMP® 200 display screen and/or output to a USB flash drive, computer or
network server, or printer.
The RAMP® 200 can be operated in either local (manual transfer) or network (auto transfer) mode.
Interaction with the RAMP® 200 is through its touchscreen display and user input is accepted from
either the touchscreen keyboard or an optional barcode scanner. Stored data, including results, can be
transferred via USB flash drive, sent to a printer or uploaded to a computer network.
The measurement process is based on the use of antibodies, biologically-derived binding agents that can
be used to specifically identify and bind to target analytes (e.g., analyte indicative of cardiac damage).
The RAMP® 200 Platform consists of two components: a disposable Test Cartridge that houses an
analyte specific immunochromatographic strip and a portable fluorescence analyzer. A "sandwich"
immunoassay format is followed. Target-specific antibodies are used to tag fluorescently labeled latex
particles. In addition, target-specific antibodies are immobilized at the detection zone of the
immunochromatographic strip. The RAMP® 200 also incorporates a quantitative Internal Standard that
is run and measured concurrently in every test. In a typical test, the operator adds sample, and antigen-
bound fluorescent particles are captured at the detection zone (i.e., the antigen is "sandwiched"
between the detection zone antibodies and the antibodies on the latex particle) and a portion of excess
particles that are not bound to antigen and do not bind at the detection zone are captured at the
control zone. The instrument measures fluorescence emitted by the complexes captured in the
detection and control zones and calculates a ratio between these measurements. The more analyte
present in the sample, the greater the number of antibody-binding sites that will be occupied, and
correspondingly, a greater number of fluorescently-labeled latex particles will be captured at the
detection zone.

Refer to the individual RAMP® Test Instructions for Use (IFU) for a detailed description of result
interpretation. Depending on the test used, the result interpretation may vary due to specific Assay
properties.
Full operation of the RAMP® System requires the use of RAMP® Test Kits and components. Optional
accessories include a printer and barcode scanner.
RAMP® 200 is comprised of the following components:
User interface and connectors for all peripherals. Stores and displays Test results (view, print, transfer,
search, and filter/sort).
Features two testing ports for performing simultaneous RAMP® 200 Assays. A maximum of three TMs
can connect to a CM.
Power supply cord and interconnect cable to connect CM and TM.
Pre-configured with:
The following four file folders: patient, lqc, iqc and log. For use in bi-directional information
transfer in a non-networked environment. Also contains a version of File Converter (Excel).
Refer to Exporting or Printing Test Result or Event Log Data section.
Refer to Manually Transferring/Printing Results section.
The Reader Configuration Utility (RCU) software executable file. Allows customized settings for
the RAMP® 200.
Electronic version of this User Manual.

B

Operation should be conducted by personnel who have undergone training. Prior to operating the
Platform, operators are required to have knowledge of relevant guidelines and norms as well as the
information and procedures contained in the User Manual and supplied USB.
Carefully follow the procedures specified in the User Manual for the operation and maintenance of the
RAMP® 200. Maintenance not described in the User Manual should be left to trained Response
Biomedical Technical Support personnel.
The RAMP® 200 and its related devices and accessories are designed to provide safe and reliable service
when used according to the instructions provided in this Operator Manual.
The following warnings and precautions should be followed in order to avoid unsafe actions with the
RAMP® 200 that could potentially result in personal injury or device damage.
NOTE
For U.S. customers, the RAMP® 200 must be operated in a laboratory setting when used with the
RAMP® Cardiovascular Tests.
WARNING
To reduce the risk associated with potentially infectious patient samples:
Do not spill specimen or sample fluids or any of the RAMP® 200 components or on the outside
of the Test Cartridge.
If a spill occurs, disinfect external surfaces only using a soft cloth containing a solution of 0.5%
bleach or 70% ethanol.
To reduce the risk associated with hazardous voltage:
Unplug the RAMP® 200 before cleaning.
Do not immerse any of the RAMP® 200 components in water.
Do not use the RAMP® 200 if there is apparent damage to a power cord or power supply.
CAUTION
To reduce the risk associated with environmental contamination:
Dispose of instrument and accessories in accordance with federal, state, and local
requirements.
Do not open any RAMP® 200 device enclosures, this will void warranty.
To reduce the risk associated with incorrect test results:
RAMP® 200 should only be used by trained professionals and operated in accordance with
facility policies and procedures.

C

Inspect all components carefully. If any damage is visible, notify the carrier and your distributor or notify
Response Biomedical Corp. to arrange for repair or replacement.
Item
Description
RAMP® 200 Control Module (CM)
RAMP® 200 Control Module
RAMP® 200 User Manual
Power Supply*
USB Flash Drive**
RAMP® 200 Test Module (TM)
RAMP® 200 Test Module
Interconnect cable
*Use only the approved power cord provided with the RAMP® 200. A power cord approved for the
North American market is provided with each CM.
** Use the manufacturer-supplied USB flash drive. If a USB flash drive is supplied by the
User/Operator, ensure that the drive folders match those folders listed in Exporting or printing
Assay result or event log data OR Manually Transferring/Printing Test Results section.
Additional accessories supported by the RAMP® 200 include an optional printer and a barcode scanner.
Only use the approved USB cables that are supplied with the components.
NOTE
Only one of each type of device can be connected to a CM at any given time.

Item
Description
Printer
Barcode printer for self-adhesive roll labels, 2 - 2.5-inches
wide. Connects to the CM via USB. Zebra®Technologies TLP
2824™ or TLP 2824 PlusTM.
*NOTE: TLP 2824 PlusTM is compatible with CM V1.3 or
later software only.
Consumables:
Requires 2.25” W x 3” L Z-Select 4000T labels from Zebra®
Technologies (p/n: 800222-305).
Requires 57mm x 74m wax/resin ribbon from Zebra®
Technologies (part number: 800132-102).
Additional information available at www.zebra.com or
phone [phone].
Printer
(*Chinese
printing
capability)
Barcode printer for self-adhesive roll labels, 2 - 2.5-inches
wide. Connects to the CM via USB. Zebra®Technologies
888-TT™.
Consumables:
Requires 2.25” W x 3” L Z-Select 4000T labels from Zebra®
Technologies (p/n: 800222-305).
Requires 64mm x 74m wax/resin ribbon from Zebra®
Technologies (part number: 03200GS06407).
Additional information available at www.zebra.com or
phone [phone].
NOTE: This printer is only compatible with CM software
version 1.3 or later. This printer supports printing in
Chinese.
Barcode
Scanner
(with cradle)
Omni-directional, hands-free barcode scanner for entering
operator and patient/sample ID. The barcode scanner is
shipped in the correct configuration and is ready for use
after connecting to the CM via USB. Symbol Technologies
Inc. model LS9208. Additional information available at
www.motorolasolutions.com, 1.800.653.5350

1 Place RAMP®200 components on a stable work surface within reach of an electrical outlet
(and network connection, if available). Access to the back of each module is required to
connect components.
Refer to Figure 2 for connector locations.
2 Remove the dust protection stickers from TM ports.
3 Connect the TM and any optional devices to the CM using the supplied interconnect cable(s).
4 Connect the supplied power cord to the CM. Plug the other end into a wall socket.
NOTE
Up to three TMs can be connected to each CM.
TMs can be stacked vertically or horizontally (one on top of
another).
CM can be placed on top of the TM.
Figure 1: RAMP®200 - front view
RAMP®200 Control Module
Touchscreen display
Test cartridge ports
RAMP®200 Test Module
(a maximum of three TMs
can be connected to the CM)
Lot card
insertion slot
Port LEDs

Figure 2: RAMP® 200 - rear view
RAMP®200 Control Module
Power on/off
Power cord connector
Ethernet connector
USB connectors for optional
printer, barcode scanner
and flash drive
RAMP®200 Control Module
to RAMP®200 Test Module
connectors
RAMP®200 Test Module
CAUTION
Do not stack a CM on top of a TM unless all four feet of the CM
rest on the TM housing.
Do not place anything on top of the CM.
Figure 3: RAMP® 200 Control Module - rear panel label

Figure 4: RAMP® 200 Test Module - rear panel label