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Patent

www.raindancetechnologies.com/patents

Trademarks

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.

Copyrights

© 2018 RainDance Technologies, Inc. All rights reserved. RainDance Technologies, Inc. owns
the copyright to the RainDance software.

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. 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:

[email protected]

For Research Use Only. Not for use in diagnostic procedures.

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Summary of Contents for RainDrop Sense

Page 1: ...RainDrop Sense Operator s Manual...

Page 2: ...nable 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...

Page 3: ...8 Product Labels 1 8 Safety Interlock 1 8 Packing and Transport 1 8 Chapter 2 Introduction 2 1 System Overview 2 2 RainDrop System Major Components 2 2 RainDrop Sense Major Components 2 3 RainDrop Se...

Page 4: ...og and Status Tabs 4 14 Chapter 5 Performing a Sense Run 5 1 Introduction 5 2 Gathering Supplies 5 2 Starting a Sense Run 5 3 Completing the ICS Setup 5 9 Checking the Status Indicators 5 9 Completing...

Page 5: ...System After a Failure 7 6 Support Agreement Information 7 6 Moving the System 7 7 Storing the System 7 7 Reinstalling Updating ICS Application 7 7 Error Messages 7 7 Troubleshooting 7 8 Chapter 8 Was...

Page 6: ...echanical Safety page 1 8 Gas Pressure Safety page 1 8 Product Labels page 1 8 Safety Interlock page 1 8 Packing and Transport page 1 8 About this Manual This manual is designed to serve the operators...

Page 7: ...rvice 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 ma...

Page 8: ...urce instrument contact your RainDance Support representative Chapter 7 of this manual includes a list of problems and possible solutions The information given is general Some applications may require...

Page 9: ...Important An Important note is similar to a regular Note except that it is meant to communicate greater weight to the issue at hand Warnings Warnings are represented by a red triangle with an exclama...

Page 10: ...accessing those areas reserved for trained service representatives Biohazard Safety Warnings A biohazard warning indicates that the user must use precautions for example gloves when handling biologica...

Page 11: ...injury from the lasers 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 contin...

Page 12: ...isconnect 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...

Page 13: ...instrument to another location contact RainDance Support Gas Pressure Safety Do not exceed a maximum input pressure of 120 psi at the instrument Product Labels Figure 1 2 shows the RainDrop Sense pro...

Page 14: ...age 2 2 RainDrop System Major Components page 2 2 RainDrop Sense Major Components page 2 3 RainDrop Sense Layout page 2 4 RainDrop Carrier and Drive Oils page 2 4 RainDrop Sense Barcode Reader page 2...

Page 15: ...Dance 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...

Page 16: ...l LCN 50 04344 Rev D 2 3 RainDrop Sense Major Components Figure 2 2 shows the major components of RainDrop Sense instrument Instrument control workstation monitor RainDrop Sense instrument Figure 2 2...

Page 17: ...se 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 surfact...

Page 18: ...the limits of supported barcode formats Figure 2 4 RainDrop Sense Barcode Reader Scanning Barcodes Scan items as follows 1 Click Scan in the ICS software The red scanner light pulses for 10 seconds 2...

Page 19: ...s where the Sense instrument identifies and counts the droplets Microfluidic chip Droplet detection region of interest ROI Fluid lanes Chip alignment hole Chip alignment hole Waste collection area Oil...

Page 20: ...eded 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 yo...

Page 21: ...e Connections USB 1 USB 3 0 and 1 USB 2 0 Required compressed gas input pressure range at the instrument 90 120 PSI 0 62 MPa 0 82 MPa Capacity 8 lanes per chip Maximum Sample Throughput per 8 hour shi...

Page 22: ...o 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...

Page 23: ...5 85 RH non condensing Atmospheric Pressure 101 81 kPa 1010 810 mbar or sea level to 1800 m Safety Compliance IEC 61010 1 2010 the international safety standard for laboratory equipment including USA...

Page 24: ...ntroller page 3 3 Connecting Cables to the RainDrop Sense Instrument page 3 3 Connecting Cables to the Instrument Controller page 3 4 Gas Pressure Quality page 3 7 Starting Up the RainDrop Sense Instr...

Page 25: ...es 71 1 cm Minimum Depth 19 inches 48 3 cm Bench Loading Weight 73 lb 26 4 kg Minimum Width 29 inches 74 cm Note Refer to the Pre Site Guide for any additional installation details Caution The RainDro...

Page 26: ...scribed 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...

Page 27: ...g 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...

Page 28: ...om the Sense USB port that connects to the right output from the Sense HDMI port that connects to the monitor Figure 3 2 Cable Connections to the IC Workstation The left USB output connects to the USB...

Page 29: ...eceiver 1 With the IC Workstation turned off plug the USB receiver for the keyboard and mouse into the IC Workstation 2 Plug the right USB output from the Sense instrument into the right USB in Figure...

Page 30: ...d gas system you use meets the following standards The input pressure must be regulated to a value at the system within the range of 90 120 psi In addition the quality must meet the ISO DIS8573 compre...

Page 31: ...to the Windows 7 operating system using the RDT account Note Logging on using any other account results in ICS failures User name RDT No password 4 Turn on the RainDrop Sense instrument located on the...

Page 32: ...e your instrument either within your laboratory or to another location contact RainDance Technologies Main Power LED Solid Instrument is powered on All LEDs except Main Power are rotating on and off I...

Page 33: ...page 4 2 Starting the ICS Application page 4 2 ICS Login Levels page 4 3 Changing the ICS Password page 4 5 The ICS Account Types page 4 6 ICS Initialization page 4 7 Status Indicators page 4 10 Usin...

Page 34: ...upper and lower case characters Note Do not use the RainDance Support Windows Logon This will result in ICS failure Starting the ICS Application The startup sequence works as follows 1 Power on each...

Page 35: ...oth usernames and passwords are case sensitive ICS Login Levels The ICS application supports two levels of access to the ICS program User and Administrator The ICS application is configured with two d...

Page 36: ...ount If this happens you must contact someone in your facility with an Administrator account who can either unlock or reset your password For details see Resetting Password or Unlocking an Account on...

Page 37: ...ords after initial use 1 Select Change Password from the Home menu The Change Password dialog opens Figure 4 3 Figure 4 3 Change Password Window 2 Enter the old password in the Old Password field the...

Page 38: ...ication Table 4 2 ICS Account Type Feature User Administrator Change Passwords X X Export Instrument Files X X View Runs X X Maintenance Actions X Add New Users X Edit Users X Reset Passwords X Unlock...

Page 39: ...login to the instrument the Initialization screen appears see Figure 4 4 Figure 4 4 Initialization Screen From the Initialization screen click Start Initialization to initialize the system A progress...

Page 40: ...e Click OK and contact RainDance Support See RainDance Support on page 1 3 This error is often the result of starting ICS right after you turn on the instrument RainDance recommends the following step...

Page 41: ...s are inactive until the initialization is finished Figure 4 7 Home Page From the home page you can Setup a Run see Chapter You can perform additional tasks by making selections from the drop down men...

Page 42: ...that some optional fields are blank The red X indicator means there is a problem that needs to be resolved before you can continue Table 4 3 shows the status indicators and describes their meanings Ta...

Page 43: ...s the status icon for that step is updated This section provides general information on what appears on the tabs and how to complete these processes Details on how to complete each of these processes...

Page 44: ...rious items If the green check mark is displayed the item is ready to go If an orange exclamation point is displayed it means that optional fields are blank If a red X is displayed there are errors or...

Page 45: ...Run on the bottom right side of the Run Data tab This starts the process on the RainDrop Sense instrument Figure 4 10 Start Run Button Using Scan Buttons The ICS allows you to scan barcodes to enter...

Page 46: ...sts instrument errors that exist in the system If an error appears the system is in a warning or error state Different errors occur during the setup of the instrument If an error does not clear when y...

Page 47: ...page 5 3 Completing the ICS Setup page 5 10 Checking the Status Indicators page 5 10 Completing the Run Data Tab page 5 12 Completing the Run Info Tab page 5 15 Completing the Run Tabs Using the Impo...

Page 48: ...n the ICS software see Chapter 4 and Chapter 6 Note Extraneous clusters have been noted in 50ul samples run in the FAST mode on the Sense instrument For the highest quality data we recommend limiting...

Page 49: ...how to start a run on the RainDrop Sense instrument 1 Launch the ICS software for the Sense instrument and log in Figure 5 1 Login Screen 2 Click Start Initialization Figure 5 2 Initialization Screen...

Page 50: ...5 4 Note If initialization fails the ICS returns to the Initialization screen after about fifteen minutes Contact RainDance Support for assistance See RainDance Support on page 1 3 3 Click Setup a Run...

Page 51: ...Following thermal cycling carefully remove the domed caps Axygen and replace with High Speed Caps Rock the caps back and forth to seat properly then press into place Ensure the cap is secured and the...

Page 52: ...RainDrop Sense Operator s Manual LCN 50 04344 Rev D 5 6 Figure 5 5 Improperly Covered PCR Tube Strip 7 Lift the door to the fully open position A bump in the cap...

Page 53: ...RainDrop Sense Operator s Manual LCN 50 04344 Rev D 5 7 Figure 5 6 Sense Door in Fully Open Position...

Page 54: ...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 Sense instrument If the scanner does...

Page 55: ...3 Place the Chip Compression Plate over the Sense chip as shown in Figure 5 9 When the plate is properly positioned its RainDance logo should be facing you the plate should be flat and it should not b...

Page 56: ...s Observe the status indicators in the software Table 5 1 System Status Indicators Indicator Meaning Pressure Ready Indicates the status of the instrument gas pressure When the pressure is sufficient...

Page 57: ...serted properly the ready indicator is displayed Note You must scan the chip prior to use otherwise the instrument will not detect it If you have scanned the chip before inserting it and it is still n...

Page 58: ...nstrument Figure 5 11 Run Data Tab Only the following fields on the Run Data tab are required for the run to proceed Run Name Sense Chip barcode lot and serial number At least one selected lane indica...

Page 59: ...in the fields in the above table to name the file It creates one file per lane in a folder named for the Run ID as follows The filename for one lane of a run looks like this Run ID Lane Letter Lane De...

Page 60: ...field limits entry to 96 characters Import the lane information as described in see Completing the Run Tabs Using the Import Function on page 5 16 4 Select the number of droplets you want from the Dr...

Page 61: ...the instrument is out of one of these types of oil Figure 5 12 Run Info Tab Your lab procedures determine how much of the information is necessary for your specific situation Enter the run information...

Page 62: ...en a run is finished so that you do not have to continually check the instrument Select Send Run Emails on the Run Info tab If email addresses have been entered by an Administrator they appear in the...

Page 63: ...provided by the RainDrop Sense instrument Description The comments entered by the user at run time if any Start Time The date and time the run was started End Time The date and time the run ended Samp...

Page 64: ...age Figure 5 13 Sense Run Screen The center of the screen displays information about which sample is being processed The right side of the screen displays information about the progress of the run 2 W...

Page 65: ...5 Click View Run Report to review the run data 6 Click Save and Close ICS saves the data from the run in a file in FCS format which can be read by the RainDrop Analyst software Note As stated above th...

Page 66: ...ling out the Run Data tab but before clicking Start Run click Cancel This brings you back to the Instrument Status and Setup a Run Screen see Figure 5 3 and blanks out any data you have entered for th...

Page 67: ...tab The Run ID is built on the date and time as follows YYMMDDHHMM In the above image the number 1302181529 represents 3 29 pm on February 18 2013 The Sense ICS creates the folder when you click Star...

Page 68: ...e Starting the ICS Application on page 4 2 2 Click Export Data The Export Data screen opens Figure 5 15 Export Data Screen 3 Use the Start Date and End Date fields to specify a range for the data Clic...

Page 69: ...le Consider developing a file management protocol The disk drive on the ICS is large but not infinite You may need to save files to an external storage device and remove some from the internal hard dr...

Page 70: ...ly files you need to move to the computer running RainDrop Analyst II are the FCS files They should appear at the top of the sorted list 5 Select only the FCS files Right click on the collection of fi...

Page 71: ...ystem This chapter covers the following topics Introduction page 6 2 Managing Users page 6 2 Adding a New User page 6 3 Editing a User page 6 5 Deleting a User page 6 7 Resetting Password or Unlocking...

Page 72: ...strator and User Chapter 4 provides detailed information on logins and account types Important To manage users you must be logged in with Administrator privileges This chapter describes several softwa...

Page 73: ...er 1 From the Actions menu select Add New User see Figure 6 1 The Add New User dialog opens see Figure 6 2 Figure 6 2 Add New User Dialog 2 Enter the information for the new user as required see Table...

Page 74: ...s first and last names Required Email Address Specifies the user s email address Required Address Specifies the user s address Required Contact Number Specifies the user s phone number Required Privi...

Page 75: ...th administrator privileges to edit the information for an existing user or remove an existing user from the database An administrator can also add a new user from this dialog 1 From the Actions menu...

Page 76: ...The Edit User Information dialog opens for the selected user see Figure 6 4 Figure 6 4 Edit User Dialog Box 3 Editing user information is essentially the same as adding new user information Edit the...

Page 77: ...e to login If this happens you must contact someone in your facility with Administrator privileges who can either reset or unlock your password To reset an account 1 Select the Reset Password check bo...

Page 78: ...ering a specific Start Date and an End Date inclusive on which the run was completed To view a run report 1 Select View Runs from the Actions menu see Figure 6 1 The View Run Report window opens see F...

Page 79: ...f a Sense Run Report Reports are divided into three sections The first section contains Run Name Operator RainDance ID machine name Tube Strip The second section contains a summary of how the run perf...

Page 80: ...t the report or export it to various formats such as a PDF file or an Excel file Figure 6 7 Report Menu 5 When you are done viewing the report close it by clicking on the Close box in the upper right...

Page 81: ...C Workstation page 7 2 Cleaning the RainDrop Sense page 7 2 Refilling the Oil Reservoir page 7 3 Service and Diagnostic Requirements page 7 6 Powering Off the System page 7 6 Powering On or Restarting...

Page 82: ...nance PM schedule and tasks are designed to be performed by RainDance Support personnel A number of PMs are conducted as part of the service contract agreement Contact RainDance Support for a recommen...

Page 83: ...ust be performed by RainDance Support personnel Refilling the Oil Reservoir The oil reservoir on the RainDrop Sense instrument must be refilled from time to time You will know that it is time to refil...

Page 84: ...syringe Refer to Scanning Barcodes on page 2 5 for more information on how to scan 3 Remove the cap from the tip of the syringe 4 Place a gloved finger over the end of the syringe to ensure that it do...

Page 85: ...nnected to the Fill Port 7 Continue to turn the syringe until it fits snugly Caution Do not overtighten the syringe onto the fill port 8 Press the end of the syringe and inject its contents until the...

Page 86: ...ess All technical maintenance or service is provided by RainDance Support Powering Off the System Follow this sequence to turn the system off 1 Exit the ICS application Wait 10 seconds 2 Power off the...

Page 87: ...than 30 days of the instruments Remove any RainDrop Chips and PCR tube strips from the instruments Leave the Carrier Oil and Drive Oil from the last run in the instruments Close the door Power off th...

Page 88: ...cannot start If you continue to have problems check the Alarms Tab first see Alarms Log and Status Tabs on page 4 14 Then contact RainDance Support See RainDance Support on page 1 3 The ready indicato...

Page 89: ...en I remove it from the instrument and there is liquid in the tube strip nest and the emulsion is not in the tube as expected Inspect the tube strip to see if there is a hole in the bottom of one of t...

Page 90: ...been run You must use a new chip for each run The ICS displays a message telling me that the barcode for samples is invalid You are attempting to use a barcode format for samples that is not supported...

Page 91: ...Sense The tube strip cap was not seated properly or the tube strip was not covered within 30 minutes of Source run completion Ensure that the tube strip cap is seated properly It should be even along...

Page 92: ...ignment pins The chip sensor will not detect the chip if there is an error in the barcode name If you have entered the barcode try scanning the chip then placing it in the instrument Shut down the sof...

Page 93: ...s issue in downstream analysis Use a multichannel pipettor in the future to reduce the risk of mixing up samples The Sense ICS displays a lower or higher than expected droplet count You have selected...

Page 94: ...the problem I am not receiving a text message at the end of a run even though I have entered my phone number into the email field The RainDrop Sense instrument does not support text messages You must...

Page 95: ...be strip caps Caps are pierced by the Sense instrument as part of the process Pierced tube strip caps allow evaporation and introduce the potential for cross contamination Clean the PCR tube strip nes...

Page 96: ...1 8 Chapter 8 Waste Management This chapter covers the following topics Introduction and Disclaimer page 8 2 Classification of Waste page 8 2 Anticipated Typical Waste Stream Composition page 8 3 Rec...

Page 97: ...icable environmental laws and regulations Classification of Waste Depending on applicable environmental laws and regulations the waste stream may be treated as hazardous chemical waste Depending on ap...

Page 98: ...stream is expected if all consumables and waste reagents are combined into a single waste stream Table 8 1 Solids Appearing in Waste Stream Material Sense Waste Amount wt Fluorocarbon oil from Carrier...

Page 99: ...drofluoric acid The incineration facility must be capable of handling halogenated particularly fluorinated materials Depending on applicable environmental laws and regulations the non infectious aqueo...

Page 100: ...Chapter 1 CHAPTER 9 LCN 50 04344 Rev D 9 1 9 Chapter 9 Customer Care Information This chapter covers the following topics General Care Information page 9 2 Consumables page 9 2...

Page 101: ...cetech com Contact RainDance Customer Care to Order a RainDrop System or other RainDance products Track a shipment Determine availability Check on installation Return products Issue a complaint or com...

Page 102: ...10 LCN 50 04344 Rev D 10 1 10 Chapter 10 Regulatory Information This chapter covers the following topics Sense Instrument Declaration of Conformity page 10 2 For Research Use Only Not for use in diag...

Page 103: ...RainDrop Sense Operator s Manual LCN 50 04344 Rev D 10 2 Sense Instrument Declaration of Conformity Figure 10 1 Sense Instrument Declaration of Conformity...

Page 104: ...RainDrop Sense Operator s Manual LCN 50 04344 Rev D 10 3 Figure 10 1 continued Sense Instrument Declaration of Conformity...

Page 105: ...RainDrop Sense Operator s Manual LCN 50 04344 Rev D 10 4 Figure 10 1 continued Sense Instrument Declaration of Conformity...

Page 106: ...Symbol Illustration Definition AC symbol Alternating current Ground symbol in circle Protected earth ground on Power Switch ON 0 on Power Switch OFF Fuse symbol Fuse Lightening bolt in triangle Dange...

Page 107: ...customer supplied consumables and equipment required to operate the RainDrop System Table A 1 provides a list of consumables their associated part numbers and other ordering information Caution Where...

Page 108: ...nDance 20 04410 kits RainDance P N 20 04411 0 2 mL 8 Tube PCR Tube Strips Clear Axygen P N PCR 0208 C 0 2 mL 8 tube PCR Tube Strips and Caps Axygen P N PCR 0208 CPC 0 2 mL 8 Tube PCR Tube Caps RainDan...

Page 109: ...p www coastpneumatics com KQF04 02 html 4 mm in line shut off valves In the US http www mcmaster com catalog 119 444 n4vr4p scroll down to PN4764K45 In the EU http www smc eu portal WebContent digital...

Page 110: ...uary 2018 RainDance Technologies Inc 749 Middlesex Turnpike Billerica MA 01821 Fax 978 528 6090 support Web www raindancetech com support Email customercare raindancetech com Copyright 2018 RainDance...

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