RainDance Technologies, ThunderStorm, RainDrop, ThunderBolts, RainDrop Analyst II, and
RainDrop Plus and logos thereof are trademarks of RainDance Technologies, Inc. All other
brands may be trademarks of their respective holders.
You may make a reasonable number of copies of this manual for internal use only and only for
use in connection with the RainDrop Sense Instrument. All such copies shall contain the copy
right info set forth on Page ii of this manual and this reproduction disclaimer. Except as explicitly
provided by this section, neither this manual nor any part of it may be reproduced, photocopied,
or electronically transmitted in any way without the advanced written permission of RainDance.
-
Contact
RainDance Technologies, Inc.
749 Middlesex Turnpike
Billerica, MA 01821
Fax: (978) 528-6090 (support)
Web: www.raindancetech.com/support
Email: customercare@raindancetech.com
For Research Use Only. Not for use in diagnostic procedures.
RainDrop Sense Operator’s Manual
Table of Contents
Chapter 1: Foreword 1-1
About this Manual ............................................................................................. 1-2
Sense Instrument Declaration of Conformity .................................................. 10-2
Chapter 11: Symbol Glossary 11-1
Appendix A: RainDrop
®
Consumables and Equipment A-1
LCN 50-04344 Rev. D v
Chapter 1:
CHAPTER 1
Chapter 1:
Foreword
This chapter covers the following topics:
About this Manualpage 1-1
Intended Usepage 1-2
Data Entry and Collectionpage 1-2
Design Change Disclaimerpage 1-2
Reproduction Disclaimerpage 1-3
RainDance Supportpage 1-3
Microsoft Windows Familiaritypage 1-3
Notes, Warnings, and Cautionspage 1-3
Notespage 1-4
1
Warningspage 1-4
Cautionspage 1-5
Biohazard Safety Warningspage 1-5
Laser Safety Warningspage 1-6
Safety Informationpage 1-7
Electrical Safety Warningspage 1-7
Mechanical Safetypage 1-8
Gas Pressure Safetypage 1-8
Product Labelspage 1-8
Safety Interlockpage 1-8
Packing and Transportpage 1-8
About this Manual
This manual is designed to serve the operators of the RainDance Technologies®, Inc.
(hereafter called “RainDance”) RainDrop
instructions, product illustrations, screen graphics, troubleshooting, error messages, and
other relevant information are contained in this manual. It is the operator's responsibility to
ensure that all safety instructions in this manual are strictly applied.
®
Sense instrument. All material operating
Where there is any conflict between the RainDance Software End User L
included in the software, and the terms and conditions of sale, the order of precedence shall
LCN 50-04344 Rev. D1-1
icense Agreement
be as follows: (1) the RainDance Software End User License Agreement and (2) the terms
and conditions.
Intended Use
For Research Use Only. Not for use in Diagnostic Procedures.
RainDance Technologies RainDrop Sense is the detection instrument that enables
identification and counting of target molecules in each picoliter droplet following PCR
amplification. Together the RainDance Source and RainDrop Sense instruments make up the
RainDrop Digital PCR System delivering quantitative results.
Data Entry and Collection
RainDance requires that you do not enter health information identifiable to a particular
person, or other information that is subject to regulatory or contractual protection, into any
RainDance instrument. Such information is not protected from disclosure to service or other
personnel and, as noted below, may be included in information provided to RainDance for
purposes of servicing or evaluating the performance of your instrument.
RainDrop Sense Operator’s Manual
Further, by requesting service of your RainDance instrument, you give RainDance consent to
access and use data stored in your RainDance instrument. RainDance uses the data to
troubleshoot and service the instrument in response to your service requests. RainDance
also may aggregate data collected from your instrument in response to service requests with
similar data from other customers and may use the aggregated data to improve instrument
performance.
Your instrument from RainDance is enabled with an automatic email functionality that allows
RainDance to receive performance data from the instrument from time to time without your
knowledge. You may choose to disable that functionality. Disabling that functionality prevents
the instrument from sending such data to RainDance. The data collected with this automatic
email functionality consists of the number of samples processed, the success rate of the
samples processed, data specific to the performance of your instrument, and data that is
entered by your operators. RainDance collects this data solely so that it may better
understand and improve instrument performance. By allowing the functionality to remain
enabled, you give RainDance permission to use the automatic email functionality.
Design Change Disclaimer
Due to design changes and product improvements, information in this manual is
subject to change without notice. RainDance reserves the right to change the product
design, including illustrations, screen shots, and diagrams, at any time without notice to
anyone, which may subsequently affect the contents of this manual.
LCN 50-04344 Rev. D1-2
RainDance assumes no responsibility for any errors that may appear in this manual.
RainDance will make every commercially reasonable effort to ensure that this manual
is up-to-date and corresponds with the shipped RainDrop Sense Instrument.
The depictions of the workstation screens in this manual are representative only.
Depending on the hardware and software versions of the system, minor differences
may appear between the actual displays and those shown in this manual.
Reproduction Disclaimer
You may make a reasonable number of copies of this manual for internal use only and only
for use in connection with the RainDrop Sense Instrument. Except as provided by the
previous sentence, neither this manual nor any part of it may be reproduced, photocopied, or
electronically transmitted in any way without the advanced written permission of RainDance.
RainDance Support
If you have any difficulty running the RainDance Source instrument, contact your RainDance
Support representative.
solutions. The information given is general. Some applications may require additional
procedures or equipment modification. Contact RainDance Support via email:
support@raindancetech.com, Monday through Friday, excluding holidays.
Chapter 7 of this manual includes a list of problems and possible
RainDrop Sense Operator’s Manual
Microsoft Windows Familiarity
The supplied Instrument Control Software (ICS) is designed for the Microsoft®
Windows® Embedded 7 operating system and uses the standard Windows interface.
This manual assumes that you are familiar with these standard techniques: clicking the
mouse, highlighting an item, right-clicking, dragging, using the keyboard, interacting
with dialog boxes, keyboard commands, selection techniques, and other Windows
basics.
If you require assistance with these aspects of the software user interface, refer to the
Microsoft Windows documentation.
Notes, Warnings, and Cautions
The symbols described in this section are used throughout this document to draw your
attention to specific situations involving safety and proper use of the equipment. Symbols
found on the instruments are listed in
Chapter 11: “Symbol Glossary.”
LCN 50-04344 Rev. D1-3
Notes
Warning: A Warning indicates a potentially hazardous situation that, if not avoided,
could result in serious personal injury or death to you or others. Warnings are set
within boxed rules and indented.
RainDrop Sense Operator’s Manual
Notes are set apart from the body of the document with either the word Note or Important.
They are meant to draw your attention to reminders and information that is important to
successful operation of the RainDrop Sense Instrument.
Warnings
Note: A
Important: An
communicate greater weight to the issue at hand.
Warnings are represented by a red triangle with an exclamation point inside of it. Warnings
are reserved for situations that indicate the possibility of personal injury if the instructions are
not followed.
Note indicates a useful piece of information.
Important note is similar to a regular Note, except that it is meant to
LCN 50-04344 Rev. D1-4
Cautions
Caution: Do not operate the System in a manner other than specified in this
manual. Doing so could damage the instrument or produce erroneous results.
Caution: RainDance service representatives are trained in the safe operation of the
RainDrop Sense Instrument, including accessing those areas reserved for trained
service representatives.
Warning: Follow your laboratory's procedures and regulations when handling
biohazardous materials.
Warning: RainDance suggests that users be professional and conscientious and
take the appropriate safety measures when preparing, handling, and disposing of
any biohazardous samples or waste.
Warning: When working with biohazardous samples, or waste, always follow
standard universal safety procedures (lab coats, safety glasses, gloves, mask,
etc.).
Cautions are represented by a blue triangle with an exclamation point inside of it. They
indicate that you must follow a particular procedure in order to correctly operate the RainDrop
Sense Instrument and to avoid any possible damage to the equipment or loss of
consumables.
Biohazard Safety Warnings
A biohazard warning indicates that the user must use precautions, for example, gloves, when
handling biological samples, to prevent any infections or hazards that can be caused by
them.
RainDrop Sense Operator’s Manual
In addition, users should take precautions in accordance with local, state, and national
requirements.
LCN 50-04344 Rev. D1-5
Laser Safety Warnings
Warning: A Class 3B laser is hazardous if the eye is exposed directly, but diffuse
reflections such as those from paper or other matte surfaces are not harmful. The
AEL for continuous lasers in the wavelength range from 315 nm to far infrared is
0.5 W. For pulsed lasers between 400 and 700 nm, the AEL is 30 mW. Other
limits apply to other wavelengths and to ultrashort lasers. Protective eye wear is
typically required where direct viewing of a class 3B laser beam may occur. Class3B lasers must be equipped with a key switch and a safety interlock.
The RainDrop Sense, classified as a Class 2 System, contains a Class 3B laser and Class 2
barcode laser. Avoid direct exposure to the Class 3B laser radiation when the unit is open
and interlocks are defeated. Only a qualified service person should remove the cover or
attempt to service this device, due to possible eye injury.
RainDrop Sense Operator’s Manual
A laser warning indicates that the user must use precautions whe
to avoid injury from the lasers.
In addition, users should take precautions in accordance with local, state, and national
requirements.
n operating the instrument
LCN 50-04344 Rev. D1-6
Figure 1-1: Laser Safety Warnings
Safety Information
Warning: This equipment is operated with hazardous voltages that can shock,
burn, or cause death. To reduce the possibility of electrical shock, do not remove
any fixed panels. Ensure that all service to the system is performed only by qualified
RainDance service personnel.
Warning: Remove the wall plug before servicing the equipment. Never pull cords
to remove the power cord from the outlet. Grasp the power cord plug and pull it
from the outlet to disconnect it.
Warning: Do not operate the equipment with a damaged power cord.
Warning: Ensure that there is easy and adequate clearance to the power cord so
that it can be disconnected in the event of a problem.
Warning: Position the power cord so that it cannot be tripped over, walked on,
rolled over, crimped, bent, pinched, or accidentally pulled from the wall outlet.
Warning: Connect the equipment only to a grounded outlet.
Warning: This instrument is not disconnected from the AC power source (mains)
as long as it is still connected to the wall outlet, even if the instrument is turned off.
The primary means of disconnecting the instrument is to remove the plug from the
wall outlet. Do not locate the instrument such that access to this plug is difficult.
Electrical Safety Warnings
RainDrop Sense Operator’s Manual
LCN 50-04344 Rev. D1-7
Mechanical Safety
Warning: The RainDrop Sense instrument weighs approximately 65 lbs (29 kg). To
avoid injury and damage to the instruments, do not move it without assistance from
RainDance Technologies.
Warning: The potential for serious injury to hands or fingers exists as a result of
rotating or clamping motion. Watch your hands and fingers when opening and
closing the cover. Keep your hands away from moving parts.
To move the instrument to another location, contact RainDance Support.
Gas Pressure Safety
Do not exceed a maximum input pressure of 120 psi at the instrument.
RainDrop Sense Operator’s Manual
Product Labels
Figure 1-2 shows the RainDrop Sense product label.
Figure 1-2: RainDrop Sense Product Label
Safety Interlock
The RainDrop Sense is equipped with an automatic safety interlock, which prevents it from
operating unless its door is properly closed.
Packing and Transport
RainDance provides initial shipping and installation. If you are considering moving the
RainDrop Sense instrument within your laboratory, refer to Chapter 3 for the space
requirements. Do not move the instrument without assistance from
LCN 50-04344 Rev. D1-8
RainDance Technologies.
Chapter 1:
CHAPTER 2
Chapter 2:
Introduction
This chapter covers the following topics:
RainDrop® System Overviewpage 2-2
RainDrop System Major Componentspage 2-2
RainDrop Sense Major Componentspage 2-3
RainDrop Sense Layoutpage 2-4
RainDrop Carrier and Drive Oilspage 2-4
RainDrop Sense Barcode Readerpage 2-5
RainDrop Sense Chippage 2-6
2
Handling the Sense Chippage 2-6
RainDrop Sense Chip Compression Platepage 2-7
Specificationspage 2-8
LCN 50-04344 Rev. D2-1
RainDrop Sense Operator’s Manual
RainDrop® System Overview
The RainDance RainDrop® System comprises two instruments: the RainDance Source and
the RainDrop Sense.
RainDrop System Major Components
RainDance Source Instrument
RainDrop Sense Instrument
Two Instrument Control (IC) Workstations (computers), one for each instrument
Two Instrument Control (IC) Monitors, one for each instrument
Instrument Control Cables and Peripherals
IC Workstation Power Cables
IC Monitor Power Cables
IC Keyboards
IC Mouses
IC USB Cables
Instrument Control Software (ICS)
RainDrop Analyst II™ Software
Figure 2-1: RainDrop System Major Components
LCN 50-04344 Rev. D2-2
RainDrop Sense Operator’s Manual
Instrument control workstation monitorRainDrop Sense instrument
RainDrop Sense Major Components
Figure 2-2 shows the major components of RainDrop Sense instrument.
Figure 2-2: RainDrop Sense Major Components
LCN 50-04344 Rev. D2-3
RainDrop Sense Layout
Chip alignment pins
Tube strip nest
Objective lens
Carrier oil
reservoir fill port
Carrier oil low
indicator light
Drive oil reservoir
fill port
Drive oil low
indicator light
Figure 2-3 shows the RainDrop Sense layout and oil reservoir fill ports.
RainDrop Sense Operator’s Manual
Figure 2-3: RainDrop Sense Layout
RainDrop Carrier and Drive Oils
Aqueous samples are encapsulated within each droplet on the Source instrument,
surrounded by an immiscible carrier oil. The droplets are stabilized with surfactants allowing
for robust manipulation both on and off the chip. Precise control of carrier and drive oil flow
rates on the Sense instrument allows for control of droplet spacing. Use only RainDancesupplied oils to avoid damage to the RainDrop System. The carrier oil and drive oil ports can
be filled with the oil provided in the Carrier Oil Syringe.
LCN 50-04344 Rev. D2-4
RainDrop Sense Barcode Reader
The barcode reader is used to scan barcodes that identify the various components used in
the RainDrop Sense (see Figure 2-4). The following lists the components to be scanned:
RainDrop Sense Chip(s)
RainDrop Carrier Oil
Tube Strips (May have a user-generated barcode. Scanning tube strips is optional.)
Items bearing a user-generated barcode for sample tracking (within the limits of
supported barcode formats)
RainDrop Sense Operator’s Manual
Figure 2-4: RainDrop Sense Barcode Reader
Scanning Barcodes
Scan items as follows:
1. Click Sc
2. Hold
the barcode, it automatically fills in the barcode information. The ICS accepts a
barcode in the 2D Data Matrix format, which allows up to 96 characters of text. You
may hear a subtle beep tone from the instrument when the barcode is accepted. If the
scanner does not read the barcode, the ICS software displays a message and allows
you to enter the barcode manually.
LCN 50-04344 Rev. D2-5
an in the ICS software. The red scanner light pulses for 10 seconds.
the barcode on the item in front of the barcode reader. When the scanner reads
RainDrop Sense Chip
Microfluidic chip
Droplet detection
region of interest (ROI)
Fluid lanes
Chip alignment hole
Chip alignment holeWaste collection area
Oil input gaskets
The RainDrop Sense Chip is placed into the instrument on top of the PCR tube strip. As part
of the Sense process, the chip punctures the tube strip caps and transfers the emulsified
sample through its lanes where the Sense instrument identifies and counts the droplets.
RainDrop Sense Operator’s Manual
Handling the Sense Chip
Figure 2-5: RainDrop Sense Chip
Handle the Sense Chip as follows:
Grasp the chip by its sides.
Do not touch the clear microfluidic chip and its droplet detection region of interest.
Save the bag the chip comes in for later disposal of the chip.
LCN 50-04344 Rev. D2-6
RainDrop Sense Chip Compression Plate
The RainDrop Sense Compression Plate is needed for smooth operation of the RainDrop
Sense Instrument. Position the plate over the Sense chip prior to start of the run. When the
plate is properly positioned, its RainDance logo should be facing you, the plate should be flat,
and it should not be movable left to right or front to back.
RainDrop Sense Operator’s Manual
Figure 2-6: RainDrop Sense Chip Compression Plate
LCN 50-04344 Rev. D2-7
Specifications
Table 2-1 shows the specifications for the RainDrop Sense instrument. Table 2-2 shows the
specifications for the Instrument Control (IC) Workstation.
Table 2-1: RainDrop Sense Hardware Specifications
Requirement or
Spec
ificationDescription
RainDrop Sense Operator’s Manual
Width
Depth17 inches (43.2 cm)
Height
Weight~65 lbs (~29 kg)
Power Source (Electrical)Voltage: 100 to 240 VAC, 35 W max
Clearance2 inches (5 cm) in rear
Fuses2 fuses, 2 Amperes Medium Acting
Cable ConnectionsUSB: 1 USB 3.0 and 1 USB 2.0
Required compressed gas
input pressure range at the
instrument
Capacity8 lanes per chip
Maximum Sample
Throughput per 8 hour shift
11 inches (27.9 cm)
15 inches (38.1 cm)
1 standard grounded outlet, within 6 ft (2 m) of the
instrument
90-120 PSI (0.62 MPa – 0.82 MPa)
24 samples per shift in Standard Mode
56 samples per shift in Fast Mode
Detection Time~8 lanes in 4 hours for Standard Mode (for 25 µL
sample)
~8 lanes in < 2 hours for Fast Mode (for 25 µL sample)
Droplet IdentificationPrecise control of relative pressure and oil flow rate
creates ideal spacing of the thermal cycled emulsion to
allow for proper droplet identification and analysis.
Droplet ProcessingDroplets are processed on a chip that has no moving
parts or valves. Samples have minimal contact with
either walls or air. In addition, one-time-only chip use
prevents sample cross-contamination.
LCN 50-04344 Rev. D2-8
RainDrop Sense Operator’s Manual
Table 2-2: Instrument Control (IC) Workstation Specifications
Requirement or Specification
Instrument Control (IC) Workstation
PowerVoltage: 100-240 VAC
DimensionsWidth: 1.36 inches (3.45 cm)
Weight
Clearance2 inches (5 cm) in rear
Network Connection
Description
Intel Computer: 19 V, 65 W
Standard grounded outlet within 6 ft (2 m) of the
instrument
TCP/IP connectivity (i.e., Internet) using a standard
Ethernet connector. Instruments must be placed near
an active Ethernet port so the computers can be
networked. The Instrument Control Software has the
ability to email notifications to customers if it is
networked. In addition, RainDance has software that
allows us, with customer permission, to access the
computers to look at log files to assist in
troubleshooting and to assess instrument performance.
Without Internet access, support is compromised.
Instrument Control (IC) Monitor
PowerVoltage: 100 to 240 VAC
View Sonic Monitor: 22 W max, 20 W typical
grounded outlet within 6 ft (2 m) of the instrument
Safety ComplianceIEC 61010-1:2010, the international safety standard for
Data BackupRainDance suggests using a standard backup
Description
15-30°C
<0.3°C per minute
101-81 kPa (1010-810 mbar) or sea level to 1800 m
laboratory equipment, including USA (UL), Canadian
(CSA), and European (CENELEC/EN) differences
dure for any computer system.
proce
LCN 50-04344 Rev. D2-10
Chapter 1:
CHAPTER 3
Chapter 3:
Installation and Setup
This chapter covers the following topics:
Space Requirementspage 3-2
Connecting RainDrop Sense and Instrument Controllerpage 3-3
Connecting Cables to the RainDrop Sense Instrumentpage 3-3
Connecting Cables to the Instrument Controllerpage 3-4
Gas Pressure Qualitypage 3-7
Starting Up the RainDrop Sense Instrumentpage 3-8
Relocating RainDroppage 3-9
3
Important: Only train
RainDrop
®
Sense instrument from its packaging and install it.
ed and certified RainDance Service Representatives may remove the
LCN 50-04344 Rev. D3-1
Space Requirements
Caution: The RainDrop Sense instrument is sensitive to vibration and should be
placed on a bench top that is free from vibration.
The RainDrop® Sense instrument is designed to be placed on a standard laboratory bench.
The Instrument Controller (IC) Workstation can be located on either the left or right side of the
instrument.
Table 3-1: RainDrop Sense Dimensions (Including the IC Workstation)
Minimum Height (door open)28 inches (71.1 cm)
RainDrop Sense Operator’s Manual
Minimum Depth
Bench Loading Weight73 lb (26.4 kg)
Minimum Width29 inches (74 cm)
Note: Refer to
Gas Connectivity
Gas source should be located in proximity to the instrument because the gas supply
connection is located on the back of the instrument. Use 4mm OD polyurethane tubing with
an in-line shutoff valve. See Appendix A for information on suppliers.
19 inches (48.3 cm)
the Pre-Site Guide for any additional installation details.
LCN 50-04344 Rev. D3-2
RainDrop Sense Operator’s Manual
Power switch
AC power
cable
Gas pressure
USB connections
Connecting RainDrop Sense and Instrument
Controller
Before powering on the RainDrop Sense instrument and its IC Workstation, make sure all
cables are properly connected as described in “Connecting Cables to the RainDrop Sense
Instrument” on page 3-3 and “Connecting Cables to the Instrument Controller” on page 3-4.
Connecting Cables to the RainDrop Sense Instrument
The RainDrop Sense instrument has three cable connections (AC Power Cable and two
USB) and a gas pressure connection as shown in Figure 3-1.
Figure 3-1: Cable Connections on RainDrop Sense
LCN 50-04344 Rev. D3-3
RainDrop Sense Operator’s Manual
To plug cables into the back of the Sense instrument:
1. Plug one end of the AC Power Cable into the Power Cable Connection and the other
end into a standard grounded wall outlet.
Important: The Detachable Main AC Power Cable for North America or other
countries with 120 VAC 50/60 Hz supply voltage provided for the RainDrop Sense
instrument is a 3-wire cord, 18 AWG, 10 A, 125 VAC. Never substitute a Detachable
Main AC Power Cable with a lower current or voltage rating.
2. Plug the two USB Cables into the USB Connections on the Sense instrument as
shown in
Figure 3-1.
Connecting Cables to the Instrument Controller
The RainDrop IC Workstation has USB connections used for:
The mouse
The keyboard
The RainDrop Sense instrument
Both the Source and Sense instruments connect to their IC Workstations via USB
connections.
Figure 3-2 illustrates the USB cable connections on the IC Workstation.
Note: It is important that all the USB cables on the instruments are connected to USB ports
on the workstations. Failure to connect the USB cable correctly can result in a loss of
communication with the RainDrop instrument. In addition, the USB connections on your
workstation may differ from those shown in
Figure 3-2.
LCN 50-04344 Rev. D3-4
RainDrop Sense Operator’s Manual
USB port that connects to
the left output from the
Sense
USB port that connects to
the right output from the
Sense
HDMI port that connects to
the monitor
The left USB/output connects to the USB port furthest from the gas inlet and the right USB/output
Figure 3-2: Cable Connections to the IC Workstation
connects to the other available USB port.
LCN 50-04344 Rev. D3-5
RainDrop Sense Operator’s Manual
USB receiver
LCN 50-04344 Rev. D3-6
Figure 3-3: USB Receiver
1. With the IC Workstation turned off, plug the USB receiver for the keyboard and mouse
into the IC Workstation.
2. Plu
3. Plu
g the right USB output from the Sense instrument into the right USB in Figure 3-2.
g the left USB output from the Sense instrument into left USB in Figure 3-2.
Gas Pressure Quality
You may use compressed argon or nitrogen. Ensure that the compressed gas system you
use meets the following standards.
RainDrop Sense Operator’s Manual
The input pressure must be regulated to a value, at the system, within the
120 psi.
In addition, the quality must meet the ISO/DIS8573 compressed gas qu
Class 2 for instrument quality gas, as follows:
Table 3-2:
Oil (ppm)0.1
Water (dew point)
Dirt (µ)1.0
GasPressure Quality
-40°F
ality standard,
range of 90-
LCN 50-04344 Rev. D3-7
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