RAMP® 200

Operator’s Manual
RAMP® 200 Operator’s Manual
© 2008 Response Biomedical Corporation
RAMP is a registered trademark of Response Biomedical Corporation
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.

Corporate Offices:
Response Biomedical Corporation
1781 75 Avenue W
Vancouver, British Columbia
CANADA V6P 6P2

Toll Free: 1.888.591.5577 (North America only)

Tel: 1.604.456.6010
Fax: 1.604.456.6066

Web: www.responsebio.com

Technical Assistance:
Response 24-hour Technical Support

1.604.219.6119 (International)
1.866.525.7267 (North America only)
E-mail: [email protected]

R0408 – RAMP 200 Operator’s Manual – 2r0

RAMP 200 Operator’s Manual Table of Contents

Table of Contents
Table of Contents ..................................................................................................................i

Warnings and Precautions.................................................................................................... 1

Summary of Warnings and Precautions ................................................................................2

Introduction .......................................................................................................................... 3
Overview ............................................................................................................................3
Intended Use.......................................................................................................................3
RAMP 200 Components ......................................................................................................3

Unpacking and Setup............................................................................................................ 4

Shipping Container Contents................................................................................................4
Optional Accessories (Available from Response Biomedical Corporation) ...............................4
Setup..................................................................................................................................5
RAMP 200 Control Module ..............................................................................................6
RAMP 200 Test Module ..................................................................................................6

RAMP 200 System Basics..................................................................................................... 7

Turning on the RAMP 200 for the First Time..........................................................................7
Display Icons.......................................................................................................................8
Port Identification Nomenclature ...........................................................................................8

Performing an Assay ............................................................................................................ 9

Using Lot Cards ..................................................................................................................9
Starting an Assay ................................................................................................................9

Running Quality Control ..................................................................................................... 11

Running LQC ....................................................................................................................11
LQC Icons .........................................................................................................................12
Running IQC .....................................................................................................................12

Working with Results.......................................................................................................... 13

Viewing Saved Results ......................................................................................................13
Searching for Assay Results ..............................................................................................14
Manually Transferring / Printing Results ..............................................................................15

Managing Settings.............................................................................................................. 16
Accessing the Settings Menus ............................................................................................17
Assay...........................................................................................................................17
LQC .............................................................................................................................17
Timer ...........................................................................................................................18

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RAMP 200 Operator’s Manual Table of Contents

Printer ..........................................................................................................................19
Login ...........................................................................................................................19
File ..............................................................................................................................19
About ...........................................................................................................................20
Edit Settings......................................................................................................................20
Timers .........................................................................................................................20
File ..............................................................................................................................21
Date/Time ....................................................................................................................21
Language .....................................................................................................................21
Misc.............................................................................................................................22
Restoring Defaults .............................................................................................................22
Managing Operators ..........................................................................................................23
Adding/Modifying an Operator .......................................................................................24
Searching for an Individual Operator ..............................................................................24

Editing Settings Using the Reader Configuration Utility (RCU)........................................... 25

Installation ........................................................................................................................25
Overview ..........................................................................................................................25
Getting Started ..................................................................................................................25
Emergency Password Reset Mechanism .........................................................................26
Choosing a Configuration File Access Method.....................................................................26
Setting Up a USB Flash Drive........................................................................................26
Setting Up Web Services Access:..................................................................................26
Accessing Configuration Files ............................................................................................27
Setting Up Communications Between RCU and Readers .....................................................28
Identifying Readers ............................................................................................................29
Non-networked Environment .........................................................................................29
Networked Environment ................................................................................................29
Importing Files...................................................................................................................29
Exporting Files ..................................................................................................................30
Deleting Results ................................................................................................................31
Upgrading Device Software ................................................................................................32
Restoring the Supervisor Operator ID / Password ................................................................32

Maintenance ....................................................................................................................... 33
Exterior Cleaning ...............................................................................................................33
WEEE (Waste Electrical and Electronic Equipment).............................................................33

ii
RAMP 200 Operator’s Manual Table of Contents

Troubleshooting ................................................................................................................. 34
General.............................................................................................................................34
Power On Self Test Message / IQC Messages ....................................................................34
Test Run Messages – Indicated by red port icon..................................................................34
Lot Card............................................................................................................................37
Settings Messages ............................................................................................................37
LQC Related Messages .....................................................................................................38
Warnings and Confirmation Requests .................................................................................39
Printer Errors.....................................................................................................................39
Communications Errors......................................................................................................40
USB Device Errors ............................................................................................................40

Specifications ..................................................................................................................... 42

USER AGREEMENT AND WARRANTY................................................................................ 44

RETURN POLICY .............................................................................................................44
RECEIPT OF DELIVERY ...................................................................................................44
E XCHANGE POLICY ........................................................................................................44
WARRANTY .....................................................................................................................45
EXCLUSIONS ...................................................................................................................45
LIABILITY LIMITATIONS ...................................................................................................46
RECALL POLICY ..............................................................................................................46
Technical Assistance: ........................................................................................................46

Index ................................................................................................................................... 47

iii
RAMP 200 Operator’s Manual Warnings and Precautions

Warnings and Precautions

Read all contents of this manual prior to use.

The following symbols are used on the RAMP 200, related components and accessories, or in 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! Hazardous Voltage

CAUTION. Indicates a situation, which if not avoided, could result in damage to the
device.
Consult Accompanying Documents

Consult Operator’s Manual

1
RAMP 200 Operator’s Manual Warnings and Precautions

Summary of Warnings and Precautions

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’s 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.

WARNING!

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.

To reduce the risk associated with potentially infectious patient samples:

• Do not spill specimen or sample fluids on 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, 70% isopropyl alcohol or 70% ethanol.

CAUTION.

To reduce the risk associated with incorrect results:

• RAMP 200 should only be used by trained professionals and operated in accordance with
facility policies and procedures.

To reduce the risk of instrument or accessory damage:

• RAMP 200 is not designed to withstand moisture, temperature extremes, severe shock or
vibration.
• RAMP 200 is intended for use indoors, located on a stable, stationary surface such as a
counter top.
• Do not open any RAMP 200 device enclosures, this will void the warranty.

To reduce the risk associated with environmental contamination:

• Dispose of instrument and accessories in accordance with federal, state, and local
requirements.

2
RAMP 200 Operator’s Manual Introduction

Introduction
Overview
The RAMP 200 is a rapid immunochromatographic system for performing in vitro diagnostic
analyses.
Calibration and expiration information for Test Cartridges are input to the RAMP 200 Control
Module through Lot Cards enclosed with the Test Kits.
To perform an assay, the operator places a sample into the well of a Test Cartridge and inserts
the Test Cartridge into the RAMP 200 Test Module.
Once the Test Cartridge has been inserted, no further intervention is required. A barcode on the
bottom of the Test Cartridge is read 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 less than 20 minutes per sample. Results may be
viewed on the RAMP 200 display and/or output to a printer, USB flash drive, or PC.
The RAMP 200 only accepts Test Cartridges specified for use with RAMP 200 test kits.
The RAMP 200 can operate in either local or network mode. Operator input is accepted from the
touch screen or an optional barcode scanner. Stored data including results can be transferred via
USB flash drive or sent to a printer.

Intended Use
The RAMP 200 is a general use fluorometer that analyzes results produced by immunoassays
specified by Response Biomedical Corporation.

RAMP 200 Components

The RAMP 200 is comprised of:
§ RAMP 200 Control Module (CM)
User interface and connectors for all peripherals. Stores and displays test results (view,
print, transfer, search, filter/sort)

§ RAMP 200 Test Module (TM), (1 – 3 modules per CM)

Each TM has 2 slots for performing simultaneous RAMP 200 Assays

§ CD containing Reader Configuration Utility Software (RCU)

Allows customized settings for the RAMP 200

§ Power supply and interconnect cable

§ USB flash drive

Pre-configured with 4 subdirectories (folders) named: patient, lqc, iqc and log, for use in
bi-directional information transfer in a non-networked environment. Also contains “File
Converter Utility.xls”. See Manually Transferring/Printing Results section.

Full operation requires the use of RAMP 200 Test Cartridges. Optional accessories include a
printer, barcode scanner and region specific power cords.

3
RAMP 200 Operator’s Manual Unpacking and Setup

Unpacking and Setup

Inspect all components carefully. If any damage is visible, notify the carrier and your distributor or
Response Biomedical Corporation to arrange for repair or replacement.

Shipping Container Contents

Item Description

RAMP 200 Control RAMP 200 Control Module

Module (CM)
Operator’s Manual
Reader Configuration Utility CD
Power Supply*
USB Flash Drive**

RAMP 200 RAMP 200 Test Module

Test Module (TM)
Interconnect Cable

* Use only the approved power cords provided with the RAMP 200 system. A power cord
approved for the North American market will be provided with each CM. CMs sent outside of the
North American market will be supplied with an additional power cord approved for that market.
** Use manufacturer supplied USB Flash Drive. If a USB Flash drive is supplied by the Operator,
ensure the drive folders match those folders listed in the Manually Transferring / Printing Results
section.
Optional USB devices supported by the RAMP 200 include a printer and a barcode scanner. Only
use the approved USB cables supplied with these devices.
NOTE: Only one of each type of device can be connected to the CM at any given time.

Optional Accessories (Available from Response Biomedical Corporation)

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™.
Consumables:
Requires 2.25” W x 3” L Z-Select 4000T labels from
®
Zebra Technologies
Requires 57mm x 74m Wax/Resin Ribbon from
®
Zebra Technologies
Additional information available at www.zebra.com
or 1.847.634.6700.

4
 RAMP 200 Operator’s Manual Unpacking and Setup

Item Description

Barcode Scanner Omni-directional, hands-free barcode scanner for

entering Operator and Patient/Sample ID. The
barcode scanner is shipped in the correct
(with cradle)
configuration and is ready for use after connecting to
the CM via USB. Symbol Technologies Inc. model
LS9208. Additional information available at
www.symbol.com, 1.800.653.5350 or
1.631.738.2400.

Setup
§ Place the 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 1 for connector locations.
§ Remove dust protection stickers from TM ports
§ Connect the TM and any optional devices to the CM using the supplied interconnect cable(s).
§ Connect the supplied power cord to the CM. Plug the other end into a wall socket.

Figure 1. RAMP 200 - Rear View Showing Connectors and Power Switch
RAMP 200 Control
Module

USB connectors for

optional printer,
Power On/Off barcode scanner and
Flash Drive
Power cord
connector
RAMP 200 Control
Ethernet Module to RAMP 200
connector for Test Module
connection connectors
to a network

RAMP 200 Test

Module

§ 1, 2, or 3 TMs can be connected to each CM.

§ TMs can be stacked.
§ CM can be placed on top of the TM.
NOTE: Do not place anything on top of the CM.

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RAMP 200 Operator’s Manual Unpacking and Setup

Figure 1a. RAMP 200 – Rear view panel labels and description

RAMP 200 Control Module

I – ON switch TM ports
Error! O – OFF switch

USB ports

Safety
certification
marking

WEEE Ethernet Date of

Caution
Electrical manufacture
Consult manual connection
rating
CE marking

RAMP 200 Test Module

Hardware revision number Serial number

6
RAMP 200 Operator’s Manual RAMP 200 System Basics

RAMP 200 System Basics

Figure 2. RAMP 200 Features - Front View

RAMP 200 Touch

Control Module Screen
Display

Lot Card
Insertion Slot

RAMP 200 Test

Module (3 max) Port LEDs

Test Cartridge
Ports

Turning on the RAMP 200 for the First Time

The power On/Off switch is located on the rear panel of the CM (Figure Figure 3. Home Screen
1). When the power is switched on, the RAMP 200 performs a number
of internal self-tests including IQC to ensure the system is operating
within specifications. Refer to Running Quality Control section.
When switched ON, the LEDs on the front of the TM illuminate blue.
When the power-on sequence is complete, the Home Screen is
displayed (Figure 3). The power-on sequence takes approximately
1 minute.
Once the Home Screen is displayed, selections can be made by
touching the appropriate prompt on the display (i.e., Run Assay to
initiate an assay, or Menu to go to the Main Menu (Fig. 4)). The display
is pressure sensitive and can accept input from a bare/gloved finger or
a blunt stylus.
The Reader Configuration Utility (RCU) can now be used to configure
hospital/clinic preferences. Refer to Settings Using the RCU section.

CAUTION. Pens or other sharp instruments will damage the touch screen.

7
RAMP 200 Operator’s Manual RAMP 200 System Basics

Display Icons
The left hand column of the screen displays an icon for each available port. Touching these icons
leads to a full screen display of the status of that port.
The lower left corner of the display screen, below the port icons, displays LQC, Printer and
Communication warning icons.
The meaning of the displayed icons as follows:

Icon Meaning

Port Idle Figure 4: Main Menu Screen

Port Busy

Assay Timing

Sample processing and cartridge movement

Error – (HRB for example only). For detailed

information see Troubleshooting

Aborting assay, cartridge ejecting, error message

to follow

Liquid Quality Control Warning

(Non-selectable) See Running Quality Control

Liquid Quality Control Expired Warning

(Non-selectable) See Running Quality Control

Printer Error

(Non-selectable) See Transferring Results

Data Transfer Error

(Non-selectable) See Transferring Results

Port Identification Nomenclature

Ports on the RAMP 200 are identified by a 2-character nomenclature system. The first character
is a number referring to the TM (this number can be either 1, 2 or 3 depending on how the TM is
connected to the CM; the second character is a letter (L or R) referring to the left (L) or right (R)
port for a particular TM. This is displayed at the top of the screen when the port icon is touched.
In the Results screens, the ports as referenced by TM serial number and either A (left) or B
(right).

8
RAMP 200 Operator’s Manual Performing an Assay

Performing an Assay
CAUTION.
When entering data via the CM touch screen (e.g., Sample/Patient/User ID), enter
characters one at a time as failure to do so may result in erroneous data entry.

CAUTION.
Be familiar with all of the instructions in the Test Kit Package Insert including
Warnings and Precautions prior to running an assay.

WARNING! Operator Hazard.

Observe local protocols and appropriate precautions in the collection, handling, and
disposal of specimens.

The RAMP 200 can be operated immediately after set-up using the pre-programmed default
settings. Some settings can be edited manually through the Settings menu on the CM touch
screen. Most settings can be edited using the Reader Configuration Utility (RCU) supplied with
the CM. For more information on editing user settings, refer to Managing Settings.

Using Lot Cards

Prior to running any assay, the Lot Card for that kit Lot must be read by the RAMP 200 through
insertion into the Lot Card Slot (Figure 2). The Lot Card provides Lot specific information and the
expiration date for each Test Kit and is only required to be read once for each Test Kit Lot. The
CM can store information from 50 different Lots. If the maximum is exceeded, the oldest entry is
overwritten.

To avoid damaging the Lot Card:

§ Do not touch the contact pads on the Lot Card.
§ Store the Lot Card in the anti-static pouch provided.

To use the Lot Card:

1. Hold the Lot Card so that the arrow is on the top side and pointing away.
2. Insert the Lot Card, contact end first, into the slot located on the front of the CM.
3. The display provides status messages: Reading Lot Card, Complete, Lot ID: XXX,
Remove Lot Card.
4. Remove Lot Card and store in its original pouch.
5. If an error message is displayed, or if there is no response to insertion of a lot card, refer
to the Troubleshooting Section.
6. Keep the Lot Card for the life of the Test Kit.

Starting an Assay
NOTE: The default setting of the RAMP 200 does not require an Operator ID or password. These
requirements can be edited via the Edit Operator settings menu or RCU. If using default settings,
Figure 5 will not appear.

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RAMP 200 Operator’s Manual Performing an Assay

If the following Liquid Quality Control warnings or appear, refer to Running

Quality Control.
NOTE: If a Test Cartridge is inserted and the Lot Card data is not stored in the CM, the Lot ID
XXX Not Found, Insert Lot Card or Cancel message will be displayed. The Lot Card must be
inserted within 40 seconds or the assay will be aborted. Touch OK to return to the Home Screen.

1. Touch Run Assay. If prompted, enter Operator ID and/or Figure 5: Operator Entry Screen
Password (Figure 5) using either the touch screen or the barcode
scanner. To accept the displayed information touch Accept.
Note that both the Operator ID and Password entries are case
sensitive.
2. When prompted, enter the Patient ID/Sample ID using either the
touch screen or barcode scanner (Figure 6). To accept the
displayed information touch Accept.
3. When prompted to Add Sample & Insert the Test Cartridge, the
LED on a free port of the TM will flash blue and the corresponding
icon on the display will illuminate blue (Refer to Test Kit Figure 6: Patient ID Entry Screen
Package Insert for detailed instructions on sample handling).
4. Prepare Test Cartridge as stated in the Test Kit Package Insert
and insert Test Cartridge into the flashing port.
If the cartridge is not inserted within 5 minutes of the Add
Sample & Insert prompt, the system will time-out and return to
the Main Menu.
NOTE: The Test Cartridge must be inserted into the TM within
~30 seconds of sample application. Otherwise, FAIL will be
displayed in the port icon and the assay will be aborted.

5. Do not use excessive force when inserting the Test Cartridge. The TM will guide the Cartridge
into place.
NOTE: If the cartridge won’t fit or won’t enter the cartridge port, clear the cartridge port of any
obstruction or blockage.
Once the Assay initialization message clears, the previous screen is displayed and the active

port icon shows a timer that counts up until sample flow is detected, then counts down
until the assay is complete.
To check the assay progress, touch the port icon. Touch Exit to return to the previous screen.
NOTE: Another assay can be started once Assay Initialization is complete by touching Run
Assay.
6. When an assay is complete the Test Cartridge is ejected and the corresponding port icon

displays . To view the test details touch the icon.

7. Before removing the Test Cartridge from the TM, a pre-configured note can be added to the
result from the drop down menu on the Result Details Screen (Figure 11). Once the Test
Cartridge has been removed, a note can no longer be added or changed.
Up to 10 notes can be defined using the RCU (Refer to Editing Settings Using the Reader
Configuration Unit section).
8. Remove the Test Cartridge.

10
RAMP 200 Operator’s Manual Running Quality Control

Running Quality Control

Two types of quality control test records are stored by the RAMP 200:
• LQC (Liquid Quality Control) - external surrogate sample test results.
NOTE: LQC is disabled in the default settings of the RAMP 200. LQC must be enabled and
configured through the RCU.
• IQC (Internal Quality Control) - self-diagnostic test results including a check of the power
supply voltage, system memory, cartridge transport system, LED function, incubator function
for heated assays and cartridge barcode sensor.

Running LQC
1. From the Main Menu Screen (Figure 4) touch LQC. The LQC – Figure 7: LQC - Assay List
Assay List Screen will open (Figure 7). This screen will display
the entire list of Assays sorted in ascending order by the Time to
Expiry before assay lockout.
NOTE: The Assay List is defined in RCU. Any new assays added
in the RCU will default to LQC disabled. Once the assay list is
imported into the CM, those assays with a non-zero LQC Reset
Interval will automatically have their timers start counting down
and the Overrides correctly displayed. Refer to the RCU Help
Manual for further instruction.
2. Touch Run LQC. If prompted, enter Operator ID and/or Password Figure 8: Control ID Entry Screen
(Figure 5) using either the touch screen or the barcode scanner.
To accept the displayed information touch Accept. Note: Both the
Operator ID and Password are case sensitive.
3. When prompted (Figure 8), enter the Control ID using either the
touch screen or the barcode scanner. The Control ID must be
entered exactly as entered in the RCU (case sensitive).
Touch Accept.
NOTE: When defining QC ranges in the RCU, the Control ID is
displayed having the corresponding assay name appended as a
suffix (e.g., 8731-TnI); when entering the Control ID on the CM,
be sure to enter only the Control ID (in this example, 8731)
without the assay specific suffix. It is recommended that the
control vial lot number be the assigned as the control ID.
An Invalid Control ID message will display if the Control ID has
not been entered correctly or is not recognized.
4. When prompted to Add Control & Insert the Test Cartridge, the
LED on a free port of the TM will flash blue and the corresponding
icon on the display will illuminate blue. (Refer to Test Kit
and Quality Control Package Inserts for detailed instructions)
5. Prepare Test Cartridge as per Test Kit Package Insert and insert
Test Cartridge into the flashing port.
If the cartridge is not inserted within 5 minutes of the Add
Control & Insert prompt, the system will time-out and return to
the Main Menu.
NOTE: The Test Cartridge must be inserted into the TM within
~30 seconds of sample application. Otherwise, FAIL will be
displayed in the port icon and the assay will be aborted.

11
RAMP 200 Operator’s Manual Running Quality Control

Do not use excessive force when inserting the Test Cartridge. The TM will guide the Cartridge
into place.
6. Once the Assay Initiation message clears, the LQC Status Screen is displayed and the active

port icon shows a timer that counts up until sample flow is detected, then counts down
until the assay is complete.

NOTE: Touching Run Assay or Run LQC will start another assay/LQC and the test sequence
will begin again using a different available port. The assay progress can be checked by
touching the port icon. Touch Exit to return to the previous screen.

When an assay is completed, the corresponding port icon displays and the Test
Cartridge is ejected. Touch the icon to view the test details.
7. Remove the Test Cartridge.

LQC Icons
Icon Meaning

LQC will be due shortly. Appears when the LQC timer for an assay has less
than the user defined % of time remaining until lockout.

LQC has expired for one or more assays. If icon is displayed, the LQC
Overdue, Assay Locked screen will appear if a Test Cartridge for the assay
requiring LQC is inserted. A limited number of overrides can be configured via
the RCU. If overrides are available, touch Continue to override lock out (i.e.,
perform a patient test after LQC is due). Once all overrides have been used,
LQC must be performed prior to any further patient testing.

NOTE: These warnings are display only and are not selectable. To determine the assay(s) for
which LQC is due, view the LQC – Assay List (Figure 7).
NOTE: If there is more than 1 level of LQC defined for an assay, and LQC has expired for this
assay, the LQC timer will be reset to the time at which the earliest LQC level passes in the set.
E.g., If Level 2 passes LQC but Level 1 fails, and Level 1 is repeated and passes, the "Time to
Expiry" column in the LQC menu will display the count down from the time when Level 2 passed.

Running IQC
IQC runs automatically every time the RAMP 200 is turned on. IQC can also be initiated manually
or configured to run at predefined intervals using the CM (See Edit Settings) or the RCU (See the
Editing Settings Using the RCU section).

To run IQC manually: Figure 9: IQC Status Screen

1. From the Main Menu screen (Figure 4), touch Run IQC. The
IQC Status screen is displayed (Figure 9).
IQC is started on all idle ports and will automatically start as
ports become free.
2. Touch OK to return to the Main Menu. If IQC fails, the TM port
LED illuminates red, the port icon turns red and the failed port

can no longer be used. E.g.,

12
RAMP 200 Operator’s Manual Working with Results

Working with Results

The RAMP 200 can store up to 900 results (300 patient, 300 LQC and 300 IQC). When the CM
database is full, the oldest result is over-written. Dual analyte assay results are stored as two
separate records. IQC results are stored separately for each individual test port.
In local mode only (i.e., when RAMP 200 is not connected to a network), the warning “Database
Almost Full, Backup Data” will be displayed when the patient or LQC result databases have less
than 20 spaces left. This message will continue to be displayed until the database is cleared.
In network mode – only new results that have not been previously transferred are transferred
during an upload. Data is not deleted from CM upon transfer.

Viewing Saved Results

1. From the Main Menu screen (Figure 4), touch Results. A list of Figure 10: Assay Results Screen
all assay results will be displayed (Figure 10). The most current
assay result is listed first.
NOTE: For each assay result, the Patient ID, Assay Name,
Result value, and Date/Time is displayed.
2. To view a list of LQC or IQC results, touch the circle next to the
words LQC Results or IQC (in the display header) to specify the
type of results to be viewed. The list of results will be displayed.
3. To view the details of a particular result, touch the result, and Figure 11: Results Detail Screen
then touch View (Figure 11).
4. To print the result details touch Print. Touch OK to return to the
result details. To return to the result list, touch Results List.

13
RAMP 200 Operator’s Manual Working with Results

Searching for Assay Results

Result Type Search Options

Assay Operator Name Sample/Patient ID Assay Name

LQC Operator Name Control ID Assay Name

IQC Operator Name Port

1. From the Assay (for IQC or LQC) Results screen, touch Search Figure 12: Search Assay Results
Screen
to open the Search Assay Results screen.
2. Use the drop down arrow € on the Operator Name: to change
the search parameter.
3. Use the touch screen or barcode scanner to enter the desired
value to search. Touch Alt Keys to display an extended character
set.
NOTE: Enter the first few characters or the entire name or ID to
be found.
4. Touch either All Results or Date Range. All Results is the
default setting. When Date Range is touched, the From/To Y M
D fields become active. Enter the desired dates. in YYYY MM DD
format.
5. Touch Search to generate a list of results based on the search
criteria entered. Touch Cancel to clear the search criteria and
return to the main Results Screen.
6. When viewing the records for a particular search, touch View All
to return to viewing the complete Results list.

14
RAMP 200 Operator’s Manual Working with Results

Manually Transferring / Printing Results

Results selected can be transferred to a printer, USB flash drive or to a network. It is important to
note that the user should manually delete the results from the Reader after manual transfer or
they will be transferred again, unless a specific range of results is selected when the next manual
transfer is performed.
NOTE: A USB flash drive can be used to transfer results from all Readers as the Result file
names start with their respective control module serial numbers. The USB flash drive should not
be removed from the control module while data is being transferred.
NOTE: The USB flash drive must be preconfigured with 4 subdirectories (folders) named: patient,
lqc, iqc and log, for this use.

1. From the Assay Results Screen (Figure 10). Select result(s) by Figure 13: Results Transfer Screen
touching the desired result(s), touch Transfer to open the
Results Transfer screen (Figure 13).
2. On the Results Transfer Screen touch Print, USB or Network
as desired. Only options for which the connections are available
will be functional.
3. Confirm the transfer by touching Confirm. Touch Cancel to
abort transfer. (Figure 14)
When the transfer is complete, touch OK and the Results Figure 14: Result Transfer Screen
screen will be displayed. If transfer fails the warning
icon and a failure message are displayed, touch OK to return to
Assay Results screen.
Once results have been transferred, the File Converter Utility
on the supplied USB flash drive may be used to convert the data
files to an Excel format. Open the file “File Converter Utility.xls”,
enable Macros, and follow the directions on the screen. You will
be prompted to save the Excel formatted file.

15
RAMP 200 Operator’s Manual Managing Settings

Managing Settings
Many of the features of RAMP 200 are not available until a Supervisor has configured them on
the CM (See Edit Settings) or a Full Access User has configured them with the RCU (See Editing
Settings Using the RCU). Customizable features include start date and time (for LQC timers),
operator IDs and passwords, data transfer options, print options, display language (only on CM),
network settings, LQC timers and ranges.
A few of these settings may be edited using the RAMP 200 touch screen. Most settings can be
edited using the RCU.

Feature (See Detailed Full Access User Supervisor

Descriptions Below) Edit on RCU Edit on CM

Assay defaults v
LQC v
Update / Upload Features v
Printer Settings v
Login Requirements v v (limited)
File Settings v v
Menu Idle / Timeout v
Date / Time (without Network NTP only v
Time Protocol – NTP)
Language v
Auto IQC Interval v v
Network Transfer Timers v
Sound v

16
RAMP 200 Operator’s Manual Managing Settings

Figure 15: Settings Menu

Accessing the Settings Menus
From the Main Menu (Figure 4) touch Settings. The Settings menu
requires Supervisor access. The default login for access to the
Settings menus is Operator ID: SUPERVISOR; PASSWORD:
PASSWORD. Both entries are case-sensitive. It is highly
recommended that this login be changed.
NOTE: the privilege access to this menu can be changed via the
RCU.
Touch View Settings from the Settings menu (Figure 15). This will
open the screen shown in Figure 16 below. Settings in the View
Settings Screens cannot be edited. To edit settings, go to the Edit
Settings screens.

Tab Screen
Figure 16: Settings: View Assay
Assay Tab

The settings for the ASSAY tab are edited through RCU only.
Sample/Patient ID
Defines the field name. Default is Patient ID. Alternate is
Sample ID. String length can be set from 1 to 18. Default: Min
Length: 1, Max Length: 18
New Assay Lockout
Define ability of operators to perform assays not in the assay
list. Set as either TRUE or FALSE
True: End users cannot run any assays that are not on the
RCU defined Assay List. The defined Assay List is displayed
on the LQC – Assay List Screen (Figure 7).
False: End users can run any RAMP 200 assay. Default:
False
Predefined Note
All notes predefined through the RCU are displayed. An
Operator can append one of these notes to each patient test
result prior to removing the Test Cartridge from the TM.
Once appended, the Note becomes part of the result.
NOTE: The predefined note can be up to 20 characters in
length. Make sure the note entered through the RCU is less
than or equal to 20 characters in length.

LQC
The settings for the LQC tab are edited through RCU only.
Default: Timer Reset (hours) = 0, LQC will not time-out.
To Hide LQC Results and report only PASS/FAIL
True: Pass/Fail will be displayed in place of results.
False: Actual result will be displayed
Default: False

17
RAMP 200 Operator’s Manual Managing Settings

Tab Screen

If LQC is required display LQC Timeout Warning (% remaining):

Figure 17: Settings: View LQC
Default: 10% Tab
The LQC warning icon will be displayed when 10% of the
user defined time period remains before LQC expires for any
assay.
If LQC is required display Max Failures Before Lockout:
Default: 1
The number of LQC failures allowed before the assay is
Locked Out. Can be set from 1-9.
Control ID
String length can be set from 1 to 18.
Default: Min Length: 1, Max Length: 18.
Figure 18: Settings: View Timer
Timer Tab

The ability to edit the settings of the TIMER tab varies by item
and is defined below.
Timer Intervals
Menu Idle Timeout – Edit on CM. Cannot edit through RCU.
Amount of idle time before the RAMP 200 returns to the
Home Screen. Disable by entering 0. Range: 0 -10 minutes.
Default: 5 minutes.
Update/Upload Start Date/Time – Edit through RCU only.
The date and time used to calculate the start of the following
intervals:
Update Interval - Edit through RCU only.
Interval at which the Reader checks for changes to settings in
a networked environment. Disable by entering 0. Range: 0 –
1440 minutes. Default: 1
Upload Results Interval - Edit through RCU only.
Interval at which the Reader sends changes or additions to
the Result and Event Logs in a networked environment.
Disable by entering 0. Range: 0 - 1440 minutes. Default: 0
(Disabled)
NOTE: Only new results that have not been previously
transferred are transferred during an upload. Data is not
deleted from CM upon transfer. When the CM database is
full, the oldest result is over-written.
Auto IQC Interval – Edit on CM and through RCU.
The interval between automatic IQC self--diagnostics in either
local or networked environment. Disable by entering 0.
Range: 0 – 1440 minutes. Default: 0 (Disabled)

18
RAMP 200 Operator’s Manual Managing Settings

Tab Screen

Printer Figure 19: Settings: View Printer

Tab
Edit through RCU only.
Auto Print
Automatic printing can be enabled independently for Assay,
LQC and IQC results.
On – Result will automatically print upon completion.
Off – Result will not print automatically.
Default - Off
Print Headers
Customized print header information that will be visible on
every printout.

Login Figure 20: Settings: View Login

Tab
Edit through RCU only.
Device Name –
Name that has been assigned to the device. Default: Blank.
Lockout
Disable Reader
Locked – Assays cannot be run.
Unlocked – Assays can be run (Default)
Login Requirements
Login requirements can be set independently for Operators
and Supervisors requiring None, ID and Password, ID only or
Password only. If None, an Operator ID cannot be entered
when running assays.
Default: Operators – None. Supervisors – ID and Password
Privilege Requirements
Defines the access privileges for each level user.
All Operators – Operators and Supervisors have access.
Supervisor only – Only Supervisors have access.
Defaults are shown in Figure 20.

File Figure 21: Settings: View File Tab

Edit through RCU only.

Network settings for the Reader
Network Settings
Local Only Mode - RAMP 200 is being used without being
connected to a shared network.
IP Address – Auto assigned when the RAMP 200 is
connected to a network.
MAC Address – (Machine Address Control) This is a static
address that represents the identity of the RAMP 200.
Default: Local Only Mode

19
RAMP 200 Operator’s Manual Managing Settings

Tab Screen
File Locations
The directory where the RAMP 200 files reside, defined when
implementing connectivity through the RCU.
Please consult the local IT administrator and the online help
for guidance on the use of these settings.

About Figure 22: Settings: View About

Tab
This tab displays the details the Serial Number, software and
hardware versions of the RAMP 200 System. This information
will assist in discussions with Technical Support.

Edit Settings
Touch Edit Settings on the Settings menu, login as described above and use the tabs to select
those settings to be changed. Only a supervisor, when in the default systems configuration, can
access the Settings menu. Only a supervisor can access the Settings menu
On all the Settings: Edit dialogs:
§ Use the touch screen or dropdown lists to enter/select the desired settings.
§ Touch Save to save your settings.
§ Touch Cancel to return to the previous screen without saving your changes.
§ Touch Reset to undo entry and return to the default setting.
§ Touch Alt. Keys to display extended characters (available characters will vary depending
on Language setting).

Tab Screen
Figure 23: Settings: Edit Timer Tab
Timers
The ability to edit the settings of the TIMER tab varies by item
and is defined with each item below.
IQC Interval (minutes) – Edit on CM and through RCU.
The interval between automatic IQC self-diagnostics.
Range: 0 – 1440 minutes.
Default: 0 (Disabled)

Menu Idle Timeout (minutes) – Edit on CM.

Cannot edit through RCU.
Amount of idle time before the RAMP 200 returns to the
Home Screen. Default: 5 minutes

20
RAMP 200 Operator’s Manual Managing Settings

Tab Screen
Figure 24: Settings: Edit File Tab
File
Edit on CM and through RCU.
The locations for the device, group and time server settings.
Please consult the local IT administrator and the online help
for guidance on the use of these settings.

Figure 25: Settings: Edit Date/Time

Date/Time Tab

Edit on CM. Cannot edit through RCU unless NTP is enabled.

Sets the current date and time for the RAMP 200.
If in Network Mode, the RAMP 200 date and time may be
synchronized with the NTP server. The date format in the
Reader is fixed – yyyy-mm-dd.
1. Use drop down menu to scroll through times zones and
select correct time zone offset for your location.
2. Enter Current time.
NOTE: When adjusting for changes in daylight savings time
ensure the time zone offset is adjusted – not the current time.
NOTE: Transfer and delete all results from the Reader prior
to switching time zones (e.g., when adjusting for daylight
savings time), as this will affect timestamp of transmitted
results.
NOTE: The date format in the RCU is the same as for other
applications running on that PC.

Figure 26: Settings: Edit Language

Language Tab

Edit on CM. Cannot edit through RCU.

Sets the display language for the RAMP 200.

21
RAMP 200 Operator’s Manual Managing Settings

Tab Screen
Figure 27: Settings: Edit Misc. Tab
Misc.
Network Transfer Timers – Edit on CM. Cannot edit through RCU.
Disabled (Local Mode) – RAMP 200 is set up for stand-alone
operation (Default).
Enabled – RAMP 200 is set up for network operation.
Default: Local
Sound – Edit on CM. Cannot edit through RCU.
Test – Touch to hear indicator.
On – The audio indicator is ON and sounds at the completion
of an assay and when a USB device is connected or
disconnected.
Off – The audio indicator is OFF.
Default: On
There is no volume adjustment feature.

Restoring Defaults
NOTE: Restoring device settings to factory defaults will erase all stored settings, assay results
and operator information. Back up all device databases prior to restoring factory defaults. To
transfer files from the RAMP 200 to another device, see Exporting Files.

1. From the Settings Menu (Figure 15), touch Restore Defaults. Figure 28: Settings: Restore
Defaults Screen
The Settings: Restore Defaults screen will open (Figure 28).
2. Touch Restore Defaults to restore factory defaults or Cancel to
return the Settings menu.
3. When prompted, turn RAMP 200 Off and Restart System to
complete restoration of defaults.

22
RAMP 200 Operator’s Manual Managing Settings

Managing Operators
If an Operator ID or password is required, only individuals with Operator IDs stored on the RAMP
200 can perform assays. The operator login requirements can be set on CM and RCU.

1. From the Main Menu screen (Figure 4), Touch Settings and Figure 29: Settings: Operators
Screen
enter the Operator ID and Password (Figure 5).
2. From the Settings menu (Figure 15), touch Edit Operators.
The Settings: Operators screen will open (Figure 29).

A complete list of all operators authorized to use the device with

Display Name and Operator Type is displayed.

Operator and Supervisor access privileges can be defined using

the RCU only.

Defaults: Operators: Run assays. Supervisors: Run assays and Figure 30: Settings: Operator
change settings (see Edit Settings). Detail Screen
3. To view detailed information for an Operator, touch the
Operator’s entry and touch View.
4. To modify an existing operator, touch the Operator’s entry and
touch Modify. (The Add button changes to Modify).
5. To add a new Operator, touch Add when no Operator entry is
highlighted.
6. To search for a specific Operator, touch Search. (See Searching
for an Individual Operator, below).
7. Deleting operators can only be done through the RCU.

23
RAMP 200 Operator’s Manual Managing Settings

Adding/Modifying an Operator

1. If adding a new operator, complete all desired fields in the Figure 31: Settings: Operators:
Add Screen
Settings: Operators: Add Screen (Figure 31).

NOTE: The RAMP 200 will store a maximum of 600 operators.

If modifying an existing Operator, the screen title will be

Settings: Operators: Modify and the fields will be populated.

Operator ID: Characters entered to access RAMP 200

(Maximum length 18 characters).
Display Name: Characters displayed with results for this
Operator ID (Maximum length 50 characters).
NOTE: Although 50 characters may be entered for a Display
Name, the CM screen and print out will truncate. The full 50
character Display Name will only be visible in the Edit Operators
screen in the Settings menu or through the RCU.
Password: Maximum length 18 characters.
Verify: Re-enter Password.
Expire: Date that Operator’s permission to use the RAMP 200
expires. Operator will be locked out after that date.
All operators must have an expiration date. Disable expiration
feature by setting field to 2037-01-01.
2. Use the arrow € to select the desired Operator Type:
Supervisor or Operator.
3. Touch Accept then Confirm the operator information or Cancel.

Searching for an Individual Operator

Settings: Operator: Search screen allows selection of Operators by: Figure 32: Settings: Operator
Search Screen
• Operator Name
• Operator ID
• Expiry Date.
To search for a specific Operator, select Operator Name or Operator
ID using the arrow € and the drop down list. Enter the desired Name
/ ID to search. Touch All Operators to disable expiry date fields for
searching.
To search for Operators whose permission to use the RAMP 200
expires in a given date range, touch Expiry Date and enter the date
range. Defaults: current date to current date + 10 years.
Touch Search or Cancel.
To return to the main list of Operators touch View All.

24
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

Editing Settings Using the Reader Configuration Utility (RCU)

Installation
The RCU is a software only product that can be installed on Client workstations running the
®
Microsoft Windows Operating System (2000/XP/Vista). Before beginning installation, be sure to
have the necessary login privileges for installation of software on your workstation.

1. Insert the RCU CD into an available CD drive on your workstation.

2. A welcome menu should be displayed on your workstation.

3. Select “Install Reader Configuration Utility”

4. Follow the on-screen prompts to complete the installation.

NOTE: If the installation does not auto-start - Go to START > Run and type {CD drive}:install.htm
<enter>.

Overview
The Reader Configuration Utility (RCU) allows the user to set up Readers according to the needs
their institution. The RCU stores this setup information in a set of Reader configuration files. Each
Group of one or more Readers has its own directory containing a set of configuration files that
define how the Readers in that Group operate. These files include Assay Lists and settings, LQC
Lists and settings and Operator Lists and settings. Note that more than one Group can share the
same Assay list, Control list and/or Operator list by either setting the List locations to the same
directory for each Group OR by using Save As to save a list in multiple directories.
In a network environment, Readers can be set to periodically check their assigned Group
directory for configuration changes. In addition, Readers can be configured to send new results
and log information to a network directory.
In non-networked environments, a portable USB flash drive (supplied) is used to download the
configuration files to the Reader and gather result and log files from the Reader. It is
recommended that a separate USB flash drive should be used for configuring each Reader
Group, this provides safe archive/restore functionality.
Complete instructions on the use of the RCU may be found in the RCU program under HELP or
from the START menu under All Programs > Reader Configuration > Reader Configuration
Manual.

Getting Started
Open the RCU from the START menu: All Programs Figure 33: Configuration Login
>Reader Configuration> Reader Configuration Program.
Login:
When the RCU is initially installed, the default login is User
ID: “Supervisor” and Password: “password” (case
sensitive). It is strongly recommended to change these
login details immediately to limit program access.

25
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

To change the default login: Figure 34: Reader Configuration: System

Settings
1. Select the Settings menu to open the Reader
Configuration: System Settings screen.
2. Change the User ID, Account Name and Password
under Reader Configuration Utility Accounts.
3. To save your settings select File > Save.
New RCU accounts may also added from this screen.
These accounts may be “Limited” or “Full Access”.
“Limited Access" accounts only have access to the
Controls Editor feature.
"Full Access" users have complete access to all the
program's functions.
See the RCU Help for information on adding / editing
and deleting users.

Emergency Password Reset Mechanism

If you forget your password, it may be temporarily reset to
allow access to the encoded password list. To use this
feature, type "override" in the User ID field of the RCU
Login Screen and select the "Login" button.
You will be presented with a message that says to contact
Tech Support with a five digit number (Permit #). Please
leave this prompt on the screen until you speak with your
Technical Support Representative.
After receiving an override number, type this number into
the "Password" field and click the "Login" button. You will
have temporary access to the "Settings" screen, where
you can view the user list and passwords.

NOTE: If the override number is entered incorrectly, it can

be re-entered. If the number is entered incorrectly the
second time, a new number is required.

Choosing a Configuration File Access Method

The RCU can be configured to access configuration files stored on a USB flash drive, a Network
shared drive and/or a Web server.

Setting Up a USB Flash Drive

1. Select the Settings menu to open the Reader Configuration: Systems Settings Screen
(Figure 34).
2. Select the Connection type: USB
3. Enter the “drive letter:” for the USB port that will be used.
4. Save your settings by selecting File > Save from the menu.

Setting Up Web Services Access:

1. Select the Settings menu to open the Reader Configuration: Systems Settings screen.

26
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

2. Select the Connection type: Web.

3. Enter the Web server directory. Contact the local IT administrator for the appropriate Web
server directory.
4. Save your settings by selecting File > Save from the menu.
No additional setup is required to access configuration files on a network shared drive.
Remember to Save after making changes, or the changes will be lost.

Accessing Configuration Files

A Group is defined as a common configuration shared by multiple Readers. As many Groups as
necessary can be defined. Each Group MUST have its own Directory. A Directory contains a set
of configuration files that define how the Readers in that Group operate. For example, one Group
may be defined for Readers in an emergency department environment with files saved in a
directory “ED”, while a separate set of configuration files, for use in an intensive care setting,
would be defined in the Group “ICU” and saved in a directory “ICU”.
A default Group Directory (C:\Program Files\Reader Configuration\) is set up during software
installation. If only one group is needed, the initial files can be modified and saved in this
directory.
If more than one group is needed, copy the default folder and re-name or use the Save As
command to save all files to a new directory.
If transferring files by USB, all files in the Group Directory MUST be copied to the root directory of
the USB.
Each new folder MUST contain the following files, assays.dtv, controls.dtv, grp_settings.dtv, and
userlist.opl. CAUTION. Do not change the file names

To open all files for a group: Figure 35: Reader Configuration: System
Settings
Click "File->Open Group... ", select the folder containing the
files to be used and click "OK". If only one group is being used,
the default location is C:\Program Files\Reader Configuration\.
This will open the following files; group settings, userlist, controls
and assays.

27
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

Opening an Individual Configuration File Figure 36: Open Default Configuration

If only one configuration file requires modification, for example,

when updating Operator Lists, there is no need to open all the
Group files, just the file to be changed (in this example,
userlist.opl). To do this, click on "File->Open", and then select
"Defaults...", "Network..." or "USB Device...". A “File Open”
screen will display allowing navigation to the drive containing the
files of interest.
To select different types of files to load, select the "Files of
Type" dropdown list. As each file type is selected, a list of those
files present in the currently selected directory will be made
available. Select the desired filename and then click "Open".

Setting Up Communications Between RCU and Readers

In the RCU: Open the default Group Settings file.

"Files" Tab
This page sets the file locations where the Reader(s) look for specific configuration information.
The Reader supports the HTTP, HTTPS, FTP and FTPS file transfer protocols. Directories are
specified in URL notation. Please consult the local IT administrator for guidance on the use of
these settings in the local network environment. If Readers will use the USB flash drive for
configuration information, all file location fields should be set to: file:/// as in the default settings
(except time server, which should be blank).

Examples of supported configurations are listed below. Figure 37: Reader Configuration: Group
Settings
• USB Flash drive: "file:/// "
• Web Server: "http://medsvr/RAMP 2002/ "
• Network drive: "ftp://fileserver/RAMP 200_share/ "
The Group Directory field identifies where the Reader(s) looks
for all group specific information.
The Assay List field identifies where the Reader(s) looks for its
list of supported assays.
The LQC Controls List field identifies where the Reader(s)
looks for its list of LQC controls.
The Operator Accounts List field identifies where the
Reader(s) looks for its operator list.
The Results Directory field identifies where the Reader(s)
places exported result files. In a networked environment one or
more groups can share the same destination directory.

The Device Directory field identifies where the Reader(s) should read and write device specific
information – this is typically set to the same directory as the Group Directory.
The Time Server Location allows the Reader group to access an NTP (Network Time Protocol)
server to keep the Reader's internal clocks set to the correct time. This field should be left blank
in non-networked environments or networked environments that lack access to an NTP server.

28
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

Identifying Readers
The RCU uses Reader information files to identify the Readers installed within an institution.
Once a Reader has been identified, the RCU may be used to change Reader specific settings.

Non-networked Environment
A USB flash drive is used to transfer Reader settings between the Reader and the RCU.
1. Insert a USB flash drive in an available USB port on the CM. Ensure that the USB drive
contains four folders named: lqc, patient, iqc, log.
2. Navigate to the Reader Settings screen (Figure 15) and touch export configuration
3. All settings files and result logs are exported.
4. Steps 1 to 3 can be repeated for additional Readers, if desired.
5. Insert the USB flash drive into the RCU computer’s USB drive.
6. From the RCU, click on “File->Open, select USB Device, (navigate to the correct
location of the USB Device if this function does not work automatically). Select the Files
of Type – Readers. Select the desired Reader Serial number and then click "Open".
7. Changes to settings for the selected Reader may now be defined on the Reader Settings
menu.

Networked Environment
Each Reader must be placed into network mode and must be assigned a device information
directory prior to successful bi-directional communications.
1. Using the Reader Touch screen, navigate to the Reader Settings: Edit Configuration:
File screen (Figure 24).
2. Enter the Device and Group Directory Settings for the Reader as defined in the RCU.
3. Navigate to the Reader Settings: Edit Configuration: Misc screen (Figure 27) and
enable network mode.
4. From the RCU, click on “File->Open, and then select Network. Select the Files of Type
– Readers. Browse to the device directory for the Reader of interest, select the desired
Reader serial number and then click "Open".
Settings for the selected Reader may now be defined on the Reader Settings menu.
For detailed information on all the RCU functions, refer to the Help Menu in the RCU program.

Importing Files
Device settings, including operator lists from the RCU or another RAMP 200 can be imported
using the USB flash drive.

29
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

1. From the Settings menu (Figure 15) touch Import Figure 38: Settings: Import
Configuration Screen
Configuration. The Settings: Import Configuration screen
opens (Figure 38).
2. Touch the Files required, touch Transfer.
Transfer is indicated by blue circles across the bottom of the
screen. If necessary, touch Cancel to stop the transfer.

A Transfer Complete notification (Figure 39) is displayed when

transfer is finished. Touch OK to return to the Settings menu.
Figure 39: Transfer Complete
If Transfer fails the warning icon is displayed. (Refer to the
Troubleshooting Section)

Exporting Files
Exporting files allows back-up of critical RAMP 200 information including Configuration files,
Operator Lists and Results files. Back-ups should always be created prior to relocating the RAMP
200 system.

1. From the Settings menu (Figure 15) touch Export

Configuration. The Settings: Export Configuration screen
opens (Figure 40).
2. Touch Export to USB Flash Drive.

Figure 40: Settings: Export

CAUTION! The Flash Drive must be pre-configured with 4 Configuration
subdirectories (folders). These must be named: patient, lqc, iqc
and log (case sensitive).
Transfer is indicated by blue circles across the bottom of the
screen. Ten files are transferred (listed in Figure 40, All Results
includes 3 files).

A Transfer Complete notification (Figure 41) is displayed when Figure 41: Settings: Export
Configuration
transfer is finished. Touch OK to return to the Settings menu

If Transfer fails the warning icon is displayed. (Refer to

the Troubleshooting Section)

30
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

Deleting Results
The RAMP 200 can store up to 900 results (300 patient, 300 LQC and 300 IQC). When the CM
database is full, the oldest result is over-written.
In local mode only (i.e., when RAMP 200 is not connected to a network), the warning “Database
Almost Full, Backup Data” will be displayed when the patient or QC result databases have less
than 20 spaces left.
NOTE: Prior to deleting results, transfer and store all data in accordance with applicable local,
state and/or federal guidelines or accreditation requirements and each facility’s protocol.
In network mode – only new results that have not been previously transferred are transferred
during an upload. Data is not deleted from CM upon transfer.

1. From the Settings menu (Figure 15), touch Delete Results. Figure 42: Settings: Delete Results
Screen
The Delete Results screen will open (Figure 42).
2. Touch Delete All Results or Delete Results Prior to Date.
Delete All Results:
3. Touch Confirm.
Delete Results Prior to Date:
4. Enter the desired date (Figure 43), touch Confirm.
Once Results Deleted Message is displayed touch OK to
Figure 43: Settings: Delete Results
return to the Settings menu. Prior to Date Screen

31
RAMP 200 Operator’s Manual Editing Settings Using the Reader Configuration Utility

Upgrading Device Software

1. From the main Settings menu (Figure 15) touch Upgrade. Figure 44: Settings: Upgrade Screen
The Settings: Upgrade screen will open (Figure 44).
2. Touch the appropriate selection:
§ Upgrade All Software: Upgrades CM and TM software.
§ Upgrade Port Software: Upgrades the TM
§ Upgrade Languages Only: Upgrades language
software.
§ Cancel: Return to the Settings menu without upgrade. Figure 45: Settings: Upgrade
Confirmation Screen
3. Touch Confirm to confirm software upgrades (Figure 45). Or
Cancel to return to Settings menu.
4. When prompted, turn RAMP 200 Off and restart system to
complete the upgrade.
5. During the upgrade, the LED of the port being upgraded will
flash red and blue. Follow on screen instructions.

Restoring the Supervisor Operator ID / Password

By default, only a Supervisor with a correct ID and password can access the Settings menu. If
the Password is lost and login fails the user can override and access the Settings menu.

1. From the Operator ID Entry Screen (Figure 5), type Figure 46. Password Override
Screen
OVERRIDE in Operator ID field. Touch Next.
2. The Password Override screen will open (Figure 46)
prompting the user to contact Technical Support with the
displayed permit number.
3. Technical Support will provide the user with an Override Code
that must be entered into the Override Code field.
4. Touch Accept. The CM verifies the Code and restores the
factory default. Operator ID: SUPERVISOR, Password:
PASSWORD.
5. Touch OK.
6. The screen returns to the Settings menu (Figure 15), touch
Edit Operators to go to the Operators screen (Figure 29).
Touch Default user with Operator ID: SUPERVISOR from the
Operator list, touch Modify to change the Operator ID, Display
Name, Password and Expiration Date.

32
RAMP 200 Operator’s Manual Maintenance

Maintenance
WARNING!
Do not disassemble the RAMP 200 or any of its related components and accessories.
The instrument contains no operator-serviceable components.
Possible electrical shock.
Unplug RAMP 200 devices prior to cleaning.

The RAMP 200 System requires no regular maintenance or calibration during its intended life
span, other than exterior cleaning as needed.
Any liquids on the external surface of a Test Cartridge must be cleaned before inserting into the
ports of the TM.
NOTE: The RAMP 200 does not contain any operator-serviceable components.

Exterior Cleaning
CAUTION. Possible device damage
Do not immerse the RAMP 200 or related devices in any liquid. Avoid spilling liquids
on the RAMP 200 and related accessory devices.

The external surfaces of the TM and CM can only be disinfected using a solution of 0.5% bleach,
70% isopropyl alcohol or 70% ethanol applied to a soft cloth. DO NOT USE STRONG BLEACH
(>0.5% solution) OR ACETONE! Oxidants and solvents could damage the RAMP 200 casing and
touch screen. Clean external surfaces only.
If the RAMP 200 requires repair or replacement, it must be disinfected prior to repackaging and
shipping.

CAUTION. Risk of permanent equipment damage

Do not expose the RAMP 200 to temperatures above 60°C (140°F). Do not disinfect or
sterilize the RAMP 200 using devices such as autoclaves, ultrasonic cleaners, or
pasteurizers. Use of such methods to disinfect/sterilize the RAMP 200 will cause
permanent device damage and void the warranty.

WEEE (Waste Electrical and Electronic Equipment)

Do not dispose of this product in municipal waste. Please contact Response Biomedical
Technical Support to arrange disposal and recycling.

33
RAMP 200 Operator’s Manual Troubleshooting

Troubleshooting
Refer to the following list to diagnose and resolve general errors and error messages displayed
by the CM. If additional assistance is needed, please contact Response Biomedical Technical
Support.
24-Hour Response Biomedical Technical Support
North America only: 1.866.525.RAMP (1.866.525.7267)
International: 1.604.219.6119
Email: [email protected]

General
Symptom Action

The CM touch screen is hard Contact Technical Support to report the problem.
to read (very dim), or colors
are not visible.

CM does not turn on or light Check if cable connections are loose. Check system power; ensure
up. power supply is connected. If problem persists contact Technical
Support to report the problem.

TM is not recognized by CM. Check if connections are loose. Switch the CM off and switch back
on. If problem persists contact Technical Support to report the
problem.

Power On Self Test Message / IQC Messages

Message Cause Action

No Available Ports. IQC Failed Ports are disabled. All ports are disabled. Switch
To Start the CM off and switch back on.
If problem persists contact
Technical Support to report the
problem.

Test Run Messages – Indicated by red port icon

Do not remove the cartridge. Touch red port icon for detailed information about the failure. If the
cartridge is removed, this information can only be accessed by transferring the Error Log to a PC.

Port Display Message Cause (s) Action

CTG Cartridge Error Possible defect in Test

Cartridge.

34
RAMP 200 Operator’s Manual Troubleshooting

Port Display Message Cause (s) Action

HRB High Background Possible interfering

substances in the sample
causing high running
background.

LOW Low Signal Insufficient sample

transferred to the Test
Cartridge. The Test Cartridge is ejected.
Insufficient mixing of the Remove and dispose of
sample with the supplied appropriately.
assay tip.
Repeat the assay with a fresh
Interfering substances in set of components. If problem
the sample. persists contact Technical
Support to report the problem.
Fail Sample Error 1 Sample flow occurred
before the Test Cartridge
was inserted into the port.
Delay of more than 30
seconds between sample
addition and Test Cartridge
insertion.
Insertion of a used Test
Cartridge.

Fail Sample Error 2 Sample flow has not been

detected.
Insufficient sample added to
the Test Cartridge.
Clogged sample pad.
Failure to use supplied
Assay Tip.
Insufficient mixing of
sample.

Fail Temperature Error TM not at proper Contact Technical Support to

temperature to carry out report the problem.
specific assay requested.

Error XX Port Disabled The identified port is Contact Technical Support to

disabled due to failing IQC report the problem.
e.g., Error 2R
or a transport carriage
failure. LED remains
illuminated red.

35
RAMP 200 Operator’s Manual Troubleshooting

Port Display Message Cause (s) Action

Insertion Error Remove & The Test Cartridge was not Cancel the assay or reinsert the
Reinsert inserted properly into the Test Cartridge. Fully insert Test
RAMP 200 or the operator did Cartridge until firm resistance is
not wait until prompted. felt. Do not use excessive force.
The TM will guide the Test
Cartridge into the port.

Followed by:
NOTE: The Test Cartridge must
Timed Out
User has not performed the be reinserted into the TM port
action required within time within approximately 30 seconds
period allowed. or an error message will be
displayed and the assay will be
aborted.

Repeat assay using a fresh set of

components.

Barcode Error Aborting The RAMP 200 was unable to Repeat assay using a fresh set of
Assay read the barcode on the Test components.
Cartridge.

No Free Ports All ports are being used by Touch OK, to return to the main
other assays. menu and wait until an assay is
complete before attempting to run
another test.

36
RAMP 200 Operator’s Manual Troubleshooting

Lot Card
Message / Symptom Cause Action

No response to insertion of a Lot Card Assembly not Contact Technical Support to

Lot Card. functioning. report the problem.

Lot Card Error, Reinsert The RAMP 200 was unable to Touch OK, then reinsert the Lot
read the Lot Card correctly. Card.
If the problem persists use a Lot
Card from another box of Tests
The Lot Card may have been
with the same Lot number.
removed too quickly, or not
fully inserted into the Lot Card If another Lot Card is not available
slot. or alternate lot card fails, contact
Technical Support.

Lot # XXX Not Found Insert The RAMP 200 does not Insert the Lot Card for the
Lot Card or Cancel contain the data required to run specified Lot or Cancel Assay.
Test Cartridges with that Lot #
NOTE: The correct Lot Card must
The Lot Card may not have be inserted within approximately
been read before running the 30 seconds or the assay will be
assay. aborted.
Repeat assay using a fresh set of
components.

Lot Card Expired The Lot Card inserted has Check the date/time settings
expired. Expiry falls on the last within the RAMP 200.
day of the month.
Use components that have not
expired.

Settings Messages
Message Cause Action

Access denied. Try again. The user does not have the Confirm correct login details and
login permissions necessary to try again.
access selected function.

Assay List Size Exceeded. The list of assays permitted is Delete existing assays from the
full. No further additions can be Assay List (Refer to RCU online
made. help). The maximum number of
assay entries allowed is 200.

Assay Locked, Aborting. The assay is not permitted or Contact Supervisor or RCU Full
has been locked. May occur if Access User for more
LQC has failed or assay is not in information.
the Assay List.

37
RAMP 200 Operator’s Manual Troubleshooting

Message Cause Action

Database Almost Full, Backup Displayed when RAMP 200 is Transfer data to USB device
Data not connected to a network and and delete the database.
either the patient or LQC result
databases has less than 20
spaces left. This message will
continue to be displayed until
the database is cleared.

Default Operator Restore The action to restore defaults Try this process again. If
Failed. has failed. problem persists contact
Technical Support.

ERROR: Invalid Code. Try The override code entered is Contact Technical Support, then
Again. invalid. enter the override code
provided.

ERROR: Numbers Only. Only numbers are permitted in Enter the number provided by
the override code field. Technical Support.

Invalid Password, Try Again. The password was incorrectly Retype the password and try
entered. again.

Invalid User, Try Again. The user is not recognized or Retype user details and try
has been entered incorrectly. again.

Locked, Contact Supervisor. The RAMP 200 has been locked Contact the RCU Full Access
via the RCU. User to unlock using the Reader
Settings Screen.

Unable To Find Record. The RAMP 200 cannot find the Re-enter search data and try
record requested. It may have again.
been deleted or details entered
incorrectly.

User Expired, Try Again User certification has expired or Re-enter Operator ID or contact
the details were entered Supervisor.
incorrectly.

LQC Related Messages

Message Cause Action

LQC Lockout. Ejecting. LQC is overdue for this assay LQC must be run and passed,
and no overrides are available. or a Full Access User can reset
the LQC timer and/or overrides
for this assay in Reader
Settings on the RCU.

38
RAMP 200 Operator’s Manual Troubleshooting

Message Cause Action

Invalid Control. Ejecting. Control ID does not exist for this Repeat LQC with correct
assay or has been entered Control ID or contact
incorrectly. Supervisor.

LQC Overdue, Assays Locked LQC has expired and all Run the required LQC.
available overrides have been
used. Tests cannot be run until
the required LQC has been run
and passed.

Warnings and Confirmation Requests

Message Cause Action

! All Databases Will Be Request was made to upgrade Cancel if not intended.
Erased software or reset system to
default settings.
Back up files at Settings:
Before performing this operation
Export Configuration
all databases should be backed
System will restart following up using Export Configuration
this procedure

! All Results Will Be Deleted Request was made to delete all

results.

ERROR - Missing Firmware The file required to complete the Contact Technical Support
Version File upgrade is missing.

ERROR - Upgrade Failed Upgrade failed. Restart RAMP 200 and re-try
upgrade. If problem persists
Restart to Try again
contact Technical Support.

Printer Errors
Message / Symptom Cause Action

Printer Error RAMP 200 is not able to Reconnect printer, switch on

communicate with printer. and try again.
Printer may be offline.
If printer is not being used turn
off Auto Print via RCU. Refer to
RCU help manual for details.

39
RAMP 200 Operator’s Manual Troubleshooting

Message / Symptom Cause Action

Poor print quality. Poor print quality maybe due to Refer to Printer Manual.
use of wrong print labels or print Consumables required for
ribbon. printer: Labels: 2.25” W x 3” L
Z-Select 4000T labels from
®
Zebra Technologies· Ribbon:
57mm x 74m Wax/Resin Ribbon
®
from Zebra Technologies

Failure to print. Poor cable connection or Check if cable connections are

jammed printer. loose. Check if printer is
jammed; refer to Printer Manual
for instructions. If problem
persists contact Technical
Support to report the problem.

Printer light does not turn on. Printer is not receiving power. Refer to Printer Manual. Check
system power; ensure power
supply is connected. Ensure
that switch on bottom right side
of the printer is turned to the ON
position. If problem persists
contact Technical Support to
report the problem.

Communications Errors
Message Cause Action

Network communications error,

Transfer Error Check all connections and try
or error writing to USB flash
again.
Drive.
If problem continues contact
Transfer Failed Supervisor or Technical
Support.

USB Device Errors

Message Cause Action

Multiple Printers Attached, Two USB printers are Remove additional printer.
Remove Device connected. Only one printer is
permitted.

Multiple USB Drives attached, More than one USB device of Remove the additional USB
Remove Device the same type is connected. device. Leave one connected.

40
RAMP 200 Operator’s Manual Troubleshooting

Message Cause Action

Unrecognized Scanner or Device attached not supported Remove device. NOTE:

Keyboard, Remove Device by RAMP 200. Barcode Scanner must be
configured for HID keyboard
emulation. (Refer to Scanner
Quick Start Guide)
If problem persists contact
Technical Support.

USB Not Visible. Reinsert & The USB device is not detected Re-connect the USB device and
Try Again by the RAMP 200. try again.

41
RAMP 200 Operator’s Manual Specifications

Specifications
CAUTION. Possible device damage and warranty invalidation.
Changes or modifications to this equipment, not expressly approved by the manufacturer
could void the warranty.

TM Specifications

Model Name RAMP 200 TM

Dimensions 185mm D x 195mm W x 96mm H

Weight 1.5kg

External connections (1) RS485 - TM to CM

CM Specifications

Model Name RAMP 200 CM

Dimensions 177mm D x 195mm W x 105mm H

Weight 1kg

Input Power Requirements 12 V DC, 120 W

Power supply 100 - 240 VAC, 50-60 Hz

Power cord length 4 ft (1.22 m) min from power supply to CM

Power supply input IEC 320 C14 compatible

connector

Power supply standards Certified for CE, CSA, UL, C-Tick, according to intended regions.
Conforms to WEEE and RoHS requirements for non-medical
electronic devices.

External Connections USB 2.0 and 1.1 (3 available), RJ-45 Ethernet, Serial RS -485 (3
available),

Ethernet Connectivity TCP/IP, DHCP dynamic IP addressing, SSL over TCP, HTTP,
HTTPS, FTP, FTPS

Controls On/Off toggle switch. O = off / I = on.

Touch screen: VGA LCD alpha-numeric display, accepts input from
bare finger, latex or nitrile gloved finger, or stylus.
Touch screen buttons: Main Menu, Run Assay, Run LQC, IQC,
Results, Settings, Operator List, Cartridge status area (6).

42
RAMP 200 Operator’s Manual Specifications

CM Specifications

®
Supported USB Devices Label printer: Zebra TLP 2824
Generic USB flash drive
Barcode scanner: Symbol Technologies LS9208.

Display 640 x 480 pixels, 5.7~6.5 “ diag (14.48~16.51 cm diag).

TM / CM Specifications

Operating temperature 15 - 30º C (59 - 86º F)

Storage temperature -10 - 50º C (14 - 122º F)

Operating Humidity 20 – 90% relative humidity, non-condensing.

Operating/Storage 0 – 2000m
Elevation

Complies with: United States: Title 47 CFR Part 15; Canada: Title 47 CFR Part 15 or
IEC 61326; European Union: IEC 61326; Australia: IEC 61326; Japan:
IEC 61326; China: IEC 61326.

Complies with the UL/IEC 61010-1 - Safety requirements for electrical equipment for
following IEC Standards: measurement, control, and laboratory use.
UL/IEC 61010-2-010 - Particular requirements for laboratory
equipment for the heating of materials.
UL/IEC 61010-2-081 - Particular requirements for automatic and
semiautomatic laboratory equipment for analysis and other purposes.
UL/IEC 61010-2-101 - Particular requirements for in vitro diagnostic
laboratory (IVD) equipment.
UL/IEC 60529 - Degrees of protection provided by enclosures.
UL/IEC 60825-1 - Safety of laser products - Part 1: Equipment
classification, requirements, and user guide.

NOTE: This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful interference to
radio communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own
expense.

43
RAMP 200 Operator’s Manual User Agreement and Warranty

USER AGREEMENT AND WARRANTY

This User Agreement and Warranty (this “Agreement”) is an agreement between you and
Response Biomedical Corporation (“Response”) and governs the purchase and use of your
Ramp 200 System. The Ramp 200 System comprises the Control Module (CM), one or more
Test Module(s) (TM(s)), the Reader Configuration Utility Software (RCU), the power supply and
interconnect cable, the USB flash drive; and optionally includes USB devices supported by the
RAMP 200 System such as the barcode printer and barcode scanner (“Optional USB Devices”)
(collectively “RAMP”). Non-essential software upgrades, to either the RCU and/or the CM
software, which are released subsequent to the date of purchase of RAMP are not included as
part of RAMP and are not subject to the terms of this Agreement. This Agreement sets out
Response’s warranty of RAMP, exclusions and limitations of Response’s liability to you,
provisions governing the recall, and exchange policies for RAMP, and other important provisions.
If you do not agree with any term of this Agreement, you must not use RAMP, and may return
RAMP to the RAMP Distributor from which you purchased RAMP within 30 days of the date of
receiving RAMP (“Date of Receipt”). If you use RAMP you are deemed to have agreed to the
terms of this Agreement.

RETURN POLICY
Returns must be marked as RETURN and must include proof of purchase and the bill of lading.
Returns must be received by Response within 30 days of the Date of Receipt. Upon acceptance
of the terms of this Agreement, all sales are considered final.

RECEIPT OF DELIVERY
The entire order is guaranteed to be correct. It is the customer’s responsibility to open the
package and inspect the items upon delivery. Packages that appear to be damaged should be
immediately reported to the freight carrier. Damage due to shipping is the sole responsibility of
the freight carrier and all claims are to be made by the customer directly with the carrier
immediately upon recognizing a problem. Shipping carriers may not honour late claims.
Response will not accept Returns or Exchanges due to shipping damage.
In the case of wrong-shipped items (“Wrong-Shipped Items”), the customer should notify the
Distributor of the error as soon as possible, but not later than 30 days from the Date of Receipt
(the “Exchange Period”). Exchanges for Wrong-Shipped Items are handled in accordance with
the Exchange Policy noted below.

EXCHANGE POLICY
The Exchange Policy applies only to newly purchased RAMP, including any newly purchased
Optional USB Devices, and is in effect for the Exchange Period only. Upon the expiry of the
Exchange Period, the Warranty provisions of this Agreement, if applicable, govern.
All exchanges, whether for defect or otherwise, are to be made through the Distributor where item
was purchased. Response will not accept any exchange claims directly from the customer. For
purposes of requesting an exchange, customer should contact the local Distributor’s Technical
Support Representative as soon as possible, but not later than 30 days from the Date of Receipt.
All exchange requests should be handled in accordance with this Exchange Policy.
In the case of Wrong-Shipped Items, Response will work with the Distributor to replace these
items with the proper items, at no charge to the customer. In the case of defective items
(“Defective Items”), where said defect was NOT caused by shipping damage, misuse, neglect,
unauthorized attempts to open, repair or modify RAMP, or use of RAMP with accessories or other
products that are not authorized by Response, Response will work with the Distributor to replace
the Defective Item.

44
RAMP 200 Operator’s Manual User Agreement and Warranty

Prior to shipping any item for exchange, whether the item is defective or otherwise, the Distributor
must first contact Response to obtain written authorization for the exchange. Response will
provide the instructions on how to ship the return. Response will not accept shipments without a
confirmed, written authorization. All the return items authorized for exchange must be in the
original (or equivalent) packaging and in compliance with the freight carrier’s requirements.
Response will pay the shipping charges for the product exchange.
Replaced items will be shipped to Customer (or Distributor where appropriate) upon receipt and
inspection of the Defective or Wrong-Shipped Items by Response. Replacement of all items
remains subject to in-stock availability.

WARRANTY
On the date of purchase, Response warrants to the original purchaser that RAMP will be free
from defects in material and workmanship and is fit for the purpose specifically set out in this
Owner’s Manual for a period of one (1) year from the date of the original purchase from
Response or an authorized Distributor (“Warranty Period”). This limited warranty is non-
transferable. This warranty is conditioned upon observance of the published directions included in
this Owner’s Manual. This warranty is further conditioned upon observance of directions
accompanying the products specifically designed for use with RAMP and authorized for use with
RAMP by Response (including test cartridges, control cartridges and kits containing same) (the
“RAMP Products”).
This warranty does not apply if the defect or malfunction in RAMP was caused by misuse,
neglect, unauthorized attempts to open, repair or modify RAMP, use of RAMP with accessories or
other products that are not authorized by Response or any cause other than the intended normal
use of RAMP. Under no circumstances, whatsoever shall Response be liable for any indirect or
consequential damages.
If RAMP becomes defective during the Warranty Period, and the Exchange Period has expired,
the purchaser’s sole and exclusive remedy, and Response’s sole obligation, will be to repair
RAMP. Repaired or replaced products or parts may be new or reconditioned, and are subject to
this limited warranty through the end of the original Warranty Period. Non-warranty work is
charged at the standard repair rate.
To obtain warranty service, the purchaser must contact Distributor during the Warranty Period,
provide Distributor with a dated proof of original purchase, and ship RAMP to Response in its
original (or equivalent) packaging only after receiving an authorization notice in writing, from
either Response or the Distributor. The purchaser is responsible for shipping costs to Response.

EXCLUSIONS
TO THE FULL EXTENT ALLOWED BY LAW, THIS LIMITED WARRANTY IS THE
PURCHASER’S SOLE AND EXCLUSIVE REMEDY, AND NO OTHER WARRANTIES,
CONDITIONS OR GUARANTEES OF ANY KIND SHALL APPLY, WHETHER STATUTORY,
WRITTEN, ORAL, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION
WARRANTIES, CONDITIONS OR GUARANTEES OF MERCHANTABILITY, NON-
INFRINGEMENT, FITNESS FOR A PARTICULAR PURPOSE, PERFORMANCE, QUALITY, OR
DURABILITY, ALL OF WHICH ARE DISCLAIMED. IN NO EVENT WILL RESPONSE BE LIABLE
FOR ANY SPECIAL, EXTRAORDINARY, INDIRECT OR CONSEQUENTIAL DAMAGES OF
ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF
DATA, LOST PROFITS, LOSS OF OPPORTUNITY, PATENT INFRINGEMENT, BUSINESS
INTERRUPTION, PERSONAL INJURY OR DEATH, OR ANY OTHER LOSS ARISING OUT OF,
RELATING TO, OR IN CONNECTION WITH RAMP EVEN IF RESPONSE IS ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.

45
RAMP 200 Operator’s Manual User Agreement and Warranty

LIABILITY LIMITATIONS
IF, AS A RESULT OF OR IN CONNECTION WITH ANY USE OF RAMP, WHETHER IN
CONJUNCTION WITH RAMP PRODUCTS OR OTHERWISE, RESPONSE BECOMES LIABLE
TO THE PURCHASER OR ANY OTHER PERSON FOR ANY DAMAGES, LOSSES, COSTS,
EXPENSES, OR OTHER LIABILITIES WHATSOEVER, AND REGARDLESS OF THE FORM OF
ACTION (IN CONTRACT, TORT OR PURSUANT TO STATUTE), THEN RESPONSE’S
AGGREGATE LIABILITY TO ALL SUCH PERSONS WILL BE LIMITED TO AN AMOUNT
EQUAL TO THE PURCHASE PRICE PAID FOR RAMP AND YOU HEREBY RELEASE
RESPONSE FROM ANY AND ALL OBLIGATIONS, LIABILITIES, CLAIMS OR DEMANDS IN
EXCESS OF THIS LIMITATION.
The exclusion of certain conditions and warranties and the limitation of certain liabilities are
prohibited in some jurisdictions, so these limitations and exclusions may not apply to some
purchasers.
This limited warranty is governed solely by the laws of the Province of British Columbia, Canada
and applicable federal laws of Canada, and expressly excludes the United Nations Convention for
the International Sale of Goods, and any rules of private international law or conflict of laws which
would lead to the application of any other laws. Any dispute arising from, connected with or
relating to this Agreement will be resolved by the courts of British Columbia, Canada and hereby
irrevocably submit and attorn to the original and exclusive jurisdiction of those courts in respect to
such matters. This document is in the English language. In the event this document is translated
into any other language and any inconsistency or contradiction in meaning or interpretation
results wherefrom, the English language version shall prevail and be controlling as between
Response and the purchaser.

RECALL POLICY
Recalls are actions taken by Response to remove certain serial or lot numbers of RAMP or
specific RAMP components (“RAMP Parts”), from the market. Recalls may be conducted on
Response’s own initiative, or by the request of a regulatory body. Response will inform the
Distributor of the necessary recall information in writing via email or fax. Only lot or serial
numbers of RAMP or RAMP Parts (the “Recalled Product”) that fall within the recall will be
included.
The Distributor will take full responsibility for collecting all Recalled Products from their customers
and for taking proper actions to discard, destroy, or send the Recalled Products to Response-
designated destinations as instructed.
Upon return of the Recalled Product to the Distributor, the purchaser sole and exclusive remedy,
and Response’s sole obligation will be to, at Response’s option repair the Recalled Product or
replace the Recalled Product with a an equivalent Response product (if available) of equal or
lesser value. Failure to return the Recalled Product may result in Response, at their sole
discretion, deciding not to repair or replace the Recalled Product.

Technical Assistance:
Response 24-hour Technical Support

1.604.219.6119 (International)
1.866.525.7267 (North America only)
E-mail: [email protected] www.responsebio.com

46
RAMP 200 Operator’s Manual Index

Index
24 Hour Technical Support ......................35 Assay List ..............................................29

Access Barcode
Access Denied Message......................38 Error Messages ...................................37
Access Privilege Requirements ............20 On Test Cartridge ..................................3
Configuration File Access Method.........27
Barcode Printer
Connecting Components........................5
Description............................................4
Full Access User .................................17
Label Part Number ................................4
RCU Accounts.....................................27
Manufacturer Contact Information...........4
RCU Default Login...............................26
Optional Accessories .............................4
Setting All Operator Access..................20
Ribbon Part Number ..............................4
Setting Supervisor Only Access............20
User Agreement and Warranty .............45
Supervisor ..........................................18
Barcode Scanner
Web Services Access ..........................27
Connecting to Control Module ................5
Access Privileges
Description............................................5
Defining Operator and Supervisor Access
Entering Operator ID............................10
Privileges ........................................24
Manufacturer Contact Information...........5
Analysis Time ...........................................3
Operator Input .......................................3
Assay Optional Accessories ......................... 3, 4
Assay Results Screen ..........................14 Supported USB devices .......................44
Autoprinting Assay Results...................20 User Agreement and Warranty .............45
Checking Progress ..............................10
Cautions
Defaults ..............................................17
Running an Assay .................................9
List Size Exceeded Message................38
Warnings and Precautions .....................1
Locked - Aborting Message ..................38
Cleaning
LQC Overdue - Assay Locked ..............12
Exterior Cleaning .................................34
LQC Timer ..........................................12
Manually Transferring / Printing results .16 CM .......................... 9. See Control Module
Manually Transferring Results ..............16 Turning On Power .................................7
New Assay Lockout .............................18
Communication
Performing an Assay ......................... 3, 9
Error Writing to USB Flash Drive ..........41
Search Assay Results Screen ..............15
Errors .................................................41
Searching for Assay Results ................15
Network Communication Error..............41
Starting an Assay ..................................9
Setting Up Between RCU and Readers .29
Viewing Saved Results ........................14
Configuration Files

47
RAMP 200 Operator’s Manual Index

Accessing ...........................................28 Data Transfer

Accessing on a USB flash drive, Network Error Icons ...................................... 8, 16
shared drive, or Web server..............27
Data Transfer Error Icons ..........................8
Downloading with a USB Flash Drive ....26
Locations ............................................29 Database
Opening all Files for a Group................28 Almost Full Warning.............................32
Opening an Individual File ....................29
Date/Time
Connector Locations .................................5 Adjusting for Daylight Savings Time......22
Daylight Savings Time Adjustment ........22
Control ID
Format ................................................22
Setup..................................................18
Settings ..............................................22
Control Module ..................................... 3, 4
Defaults
Cleaning Exterior .................................34
Restoring ............................................23
Configuring Settings On .......................17
Connecting the Barcode Scanner ...........5 Device Directory .....................................29
Connecting the Printer ...........................4
Device Name
Connecting to Test Module.....................5
Default Name ......................................20
Data Transfer ......................................14
Disinfecting Exterior Surfaces ..................34
Database Capacity ...................14, 19, 32
Display Names Truncated On...............25 Display Icons ...............................See Icons
Editing IQC Settings ............................13
Display Language
Editing Settings On ........................ 17, 19
Setting the Display Language ...............22
Entering Lot Card Data ........................10
Illustration and Description .....................6 Display Name

Maximum Lot Card Data Input ................9 Maximum Length .................................25

Parts and Features ................................7 Disposal and Recycling ...........................34

Power Switch Location...........................7
Ethernet Cable
Rear View .............................................5
Transferring Stored Data........................3
Restoring Supervisor Operator ID /
Password ........................................33 Exchange Policy .....................................45
Setting Operator Login On ...................24
Extended Characters
Setup....................................................5
Displaying ..................................... 15, 21
Specifications ......................................43
Troubleshooting ..................................35 File

Upgrading Software .............................33 Location Settings .................................20

Warranty .............................................45 Settings

Network settings, File location settings
Customizable Features ...........................17 ....................................................20

48
RAMP 200 Operator’s Manual Index

Files IQC Fails ............................................13

Exporting ............................................31 LQC Due Shortly .................................12
Importing ............................................30 LQC Expired - Assay Locked................12
Settings ..............................................22 LQC Warning ........................................8
Port Busy ..............................................8
Full Access User
Port Idle ................................................8
Editing Settings ...................................17
Port Timer ...........................................10
Editing Settings on Control Module .......17
Printer Error .................................... 8, 40
Full Access Users ...................................27
Sample Processing................................8
Group Status Messages Displayed On ..............8
Creating Additional Groups ..................28 Transfer Fails ......................................31
Default Directory..................................28
IQC........................................................13
Defined ...............................................28
Auto IQC Interval .................................17
Directory, Setting Up............................28
Interval ...............................................21
File Name Conventions ........................28
Running Manually................................13
Opening Group Files ............................28
Status Screen .....................................13
Settings ..............................................29
Troubleshooting ..................................35
Transferring Files by USB ....................28
Viewing/Printing Saved Results ............14
Group (of Readers)
Labels
Configuration Files...............................26
Rear Panel Labels and Descriptions .......6
Networked ..........................................26
Language
Non-networked ....................................26
Editing Settings ...................................17
Group Directory ......................................29
Settings ..............................................22
Group Settings
Languages
Setting Up in RCU ...............................29
Upgrading Software .............................33
Home Screen ...........................................7
Liability Limitations ..................................47
Icons
Limited Access Accounts.........................27
Aborting Assay ......................................8
Liquid Quality Control....................See LQC
Active Port ..........................................10
Assay Complete ............................ 10, 12 LIS (Laboratory Information System ...........3
Assy Timing ..........................................8
Local Mode ..............................................3
Cartridge Movement ..............................8
Deleting Results ..................................32
Data Transfer Error.......................... 8, 16
IP & MAC Address...............................20
Display Icons.........................................8
Lockout
Error .....................................................8

49
RAMP 200 Operator’s Manual Index

LQC Time Remaing .............................12 Timeout Warning .................................18

Settings ..............................................20 Viewing/Printing Saved Results ............14
Time to Expiry .....................................11 Warning Icons .......................................8

Log Maintenance...........................................34
Sent to Network directory .....................26 Exterior Cleaning .................................34

Login Menu Idle / Timeout

Default User ID and Password..............26 Editing Settings ...................................17
Editing Settings ...................................20
Menu Idle Timeout ..................................21
Login Requirements Editing Settings ...................................19
Editing Settings ...................................17
Messages
Operator/Supervisor Defaults ...............20
IQC ....................................................35
Setting Up ...........................................20
Test Run .............................................35
Lot Card Warnings and Confirmation Requests ...40
Enclosed with Test Kit............................3
Network
Error Messages, Troubleshooting .........38
Settings ..............................................20
How to Use ...........................................9
Network Mode ..........................................3
Insertion Slot Location ...........................7
Date and time synchronized with NTP
Lot Number Not Found ........................10
Server .............................................22
Potential Damage Warning.....................9
Deleting results ...................................32
Lot Cards Transferring Results ............................14
Using ....................................................9
Network Transfer Timers .........................23
LQC .......................................................11 Editing Settings ...................................17
Assay List ...........................................12
Note......................See Pre-configured Note
Assay List Screen.......................... 11, 18
NTP ................................................. 22, 29
Assay Timer / Time to Expiry ................12
Controls List ........................................29 NTP (Network Time Protocol) ..................17
Default Settings ...................................11
Operator
Determing Assays That Require LQC ...12
Accounts List.......................................29
Editing Settings ...................................17
Default Privileges ................................24
Icons .............................................. 8, 12
Expire Date .........................................25
Max Failures Before Lockout ................18
ID Maximum Length.............................25
Messages ...........................................39
Modifying an Existing, Adding, Searching
Results, Pass/Fail vs. Numeric .............18 For, Deleting ....................................25
Running ..............................................11 Modifying, Adding, Searching, Deleting .24
Status Screen .....................................12 Searching For .....................................25

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RAMP 200 Operator’s Manual Index

Setting Login Requirements .................24 Failure to Print .....................................41

Viewing Detailed Information ................24 Printing Results ...................................16

Operator ID ..............................................9 Privilege Requirements .............See Access

Privileges
Operators
Quality Control....................... See LQC/IQC
Defining Access Privileges ...................24
Deleting Operators ..............................24 RAMP 200
Managing Operator IDs/Passwords ......24 Overview and Product Description ..........3
Maximum Stored .................................25 System Components .............................3

Optional Accessories ................................4 RCU

Printer, Barcode Scanner .......................3 Accessing Configuration Files ..............27
Adding New Accounts..........................27
Override Code ........................................33
Changing the Default Login ..................27
Password
Date/Time Editing ................................22
Maximum Length .................................25
Defining Settings in the Reader Settings
Overriding a Lost Password .................33 menu...............................................30
Restoring Supervisor Password............33 Defualt User ID & Password .................26
Deleting Operators ..............................24
Patient ID
Editing Settings ...................................17
Editing Settings ...................................18
Editing Settings With............................26
Power Cord File Settings (Local vs. Network)...........20
Connector Location ...............................5
Indentifying Readers in Networked and
Non-networked Environments ...........30
Power-on Sequence .................................7
Instructions for Use..............................26
Preconfigured Note Language Settings...............................22
Defining ..............................................10 Login Settings .....................................20
Pre-configured Note Opening the Application .......................26

Add to Results.....................................10 Overview ............................................26

Predefined Notes .................................18
Printer
Printer Settings....................................20
Editing Settings ...................................17
Setting Date/Time Format ....................22
Error Icons ............................................8
Setting Up Communication Between RCU
Icons ....................................................8 and Readers ....................................29
Settings, Autoprint, Headers .................20
RCU (Reader Configuration Utility)
Troubleshooting ..................................40
Installation ..........................................26
Printing
Reader Configuration Utility .......... See RCU
Auto Print Settings ...............................20
Customizing Print Headers ...................20 Recall Policy...........................................47

51
RAMP 200 Operator’s Manual Index

Receipt of Delivery Agreement ................45 Network ..............................................20

Printer.................................................20
Restoring Defaults ..................................23
Restoring Defaults ...............................23
Results
Timers ................................................21
Deleting, Local and Network Mode .......32
Troubleshooting ..................................38
Manually Transferring ..........................16
Settings Menu
Maximum Number Stored ....................14
Accessing ...........................................33
Printing ...............................................16
Results Detail Screen ..........................14 Settings Menu Screen .............................18
Results Directory .................................29
Settings Menus
Results Transfer Screen ......................16
Accessing ...........................................18
Search Assay Results Screen ..............15
Setup
Transferring ........................................19
READER Components Setup .................5
Transferring Results in Network Mode ..14
Viewing Saved ....................................14 Software
Working with .......................................14 Upgrading Device Software ..................33

Return Policy ..........................................45 Sound

Setting On/Off .....................................23
Running an Assay
How to ..................................................9 Specifications .........................................43
Operator ID Entry ................................10
Supervisor
Patient ID Entry ...................................10
Configurable CM Features ...................17
Test Cartridge Preparation ...................10
Default Privileges ................................24
Using Lot Cards ....................................9
Editing Settings ...................................17
Running Quality Control ..........................10 Restoring Password.............................33

Sample ID Supervisor Access

Editing Settings ...................................18 Settings Menus ...................................18

Settings Technical Support

Date/Time ...........................................22 Contact Information .............................35
Editing Settings ...................................21
Test Cartridge
Editing with the RCU............................26
Calibraiton and Expiration Information.....3
File Locations ......................................22
Lot Number ...........................................3
Importing Device Settings ....................30
Port Locations .......................................7
Language............................................22
Preparing ............................................11
Login ..................................................20
Time Out Error ....................................11
Managing Settings ...............................17
Test Kit

52
RAMP 200 Operator’s Manual Index

Package Insert Instructions ..................10 Settings Messages ..............................38

Test Run Messages .............................35
Test Kits...................................................3
USB Device Errors ..............................41
Compatibility with Earlier READER
Models ..............................................3
Update Interval
Expiry Date on Lot Cards .......................9
Editing Timer Settings ..........................19
Package Insert Information.....................9
Upgrading Software ................................33
Test Module ..................................... 3, 4, 5
Upload Results Interval
Cleaning Exterior .................................34
Editing Timer Settings ..........................19
Illustration and Description .....................6
Inserting Test Cartridge.................. 11, 37 USB
Inserting Test Cartridges ......................10 Error Messages ...................................41
Not Recognized by the Control Module .35 Troubleshooting ..................................41
Parts and Features ................................7
USB Flash Drive
Specifications ................................ 43, 44
Configuration File Download ................26
Temperature Error ...............................36
Exporting Files With.............................31
Test Cartridge Insertion Error ...............37
Importing Files With.............................30
Upgrading Software .............................33
Preconfigured Subdirectories .................3
Warranty .............................................45
Setup..................................................27
Time Server Location ..............................29 Transferring Group Directory Files ........28
Transferring Stored Data........................3
Timers ........................................19, 21, 23
Using to Transfer Results .....................16
Editing Network Transfer Timers...........23
Editing Settings ............................. 19, 21 User Agreement .....................................45
Update Interval ....................................19
Warning
TM ................................... See Test Module Data Transfer Error.......................... 8, 16
Disassembly .......................................34
Touch Screen Display
LQC......................................................8
Location ................................................7
LQC Timeout.......................................18
Transferring
Printer Error ..........................................8
Manually Transferring Results ..............16
Warnings
Troubleshooting
LQC Warnings............................... 10, 12
Communication Errors .........................41
Warnings and Precautions .....................1
IQC Messages ....................................35
Warnings and Confirmation Requests ......40
Lot Card Messages, Issues ..................38
LQC Messages ...................................39 Warnings and Precautions
Printer Error Messages ........................40 Running an Assay .................................9

53
RAMP 200 Operator’s Manual Index

Warranty .......................................... 45, 46 Web Services

Exclusions ..........................................46 Setting Up Access ...............................27

Web Server WEEE (Waste Electrical and Electronic

Equipment ..........................................34
Supported Configurations.....................29

54