Cell Dynamics W8 User manual

ORIGINAL INSTRUCTIONS
ENGLISH / AMERICAN

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Table of Contents
1. Warnings and precautions................................................................................................................... 10
1.1. Intended use of the instrument .................................................................................................. 10
1.2. Limitations................................................................................................................................... 10
1.3. Required expertise of the operator............................................................................................. 11
1.4. Emergency stop procedure ......................................................................................................... 11
2. Safety labels, Hazards and Indicators.................................................................................................. 12
2.1. Safety instructions....................................................................................................................... 12
2.2. Delivery and Transportation........................................................................................................ 13
2.3. Area of Use and Positioning ........................................................................................................ 14
2.4. Electricity and fire hazards .......................................................................................................... 15
2.5. Electromagnetic compatibility (EMC).......................................................................................... 17
2.6. Acoustic emission ........................................................................................................................ 17
2.7. Liquid spillages and leakages....................................................................................................... 17
2.8. Temperature................................................................................................................................ 17
2.9. Mechanical hazards..................................................................................................................... 18
2.10. Chemical and Biological Hazards............................................................................................. 18
2.11. Service ..................................................................................................................................... 19
2.12. Disposal.................................................................................................................................... 20
3. Introduction and applications ............................................................................................................. 21
3.1. The W8 Physical Cytometer......................................................................................................... 21
3.2. Working principle ........................................................................................................................ 22
3.3. Applications ................................................................................................................................. 22
4. Schematic overview of the W8 Physical Cytometer............................................................................ 23
4.1. Component list ............................................................................................................................ 27
5. Installation of the W8 Physical Cytometer.......................................................................................... 28
5.1. Setting Up the W8 Physical Cytometer ....................................................................................... 28
5.2. PC requirements.......................................................................................................................... 28
5.3. LIBRA: software installation......................................................................................................... 28
6. Operative protocols............................................................................................................................. 29
6.1. Starting Up the W8 Physical Cytometer...................................................................................... 29
6.2. Filter connection.......................................................................................................................... 29

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6.3. Waste bottle positioning and connection ................................................................................... 30
6.4. W8 caps positioning .................................................................................................................... 30
6.5. Reservoirs: preparation and connection..................................................................................... 31
6.6. W8 chip information and insertion procedure............................................................................ 34
6.7. Cleaning Solution preparation..................................................................................................... 35
7. LIBRA: User Manual............................................................................................................................. 37
7.1. Experiment Settings..................................................................................................................... 37
7.2. Sorting Options............................................................................................................................ 40
7.3. Operative panel........................................................................................................................... 41
7.4. Control panel: FILL....................................................................................................................... 42
7.5. Control panel: MEASURE............................................................................................................. 44
7.6. Control panel: CLEAN................................................................................................................... 47
8. Troubleshooting: a short guideline on possible issues........................................................................ 51
8.1. Incompatible number and size of samples.................................................................................. 51
8.2. Out-of-scale liquids volumes ....................................................................................................... 51
8.3. Unsatisfactory W8 Chip status and positioning........................................................................... 51
8.4. Incorrect tubes positioning.......................................................................................................... 52
8.5. Incorrect naming of the LIBRA folder.......................................................................................... 52
8.6. Air Bubbles in the W8 Chip channel ............................................................................................ 52
8.7. Multiple samples in the W8 Chip channel................................................................................... 53
8.8. Impurities in the W8 Chip channel .............................................................................................. 53
8.9. Switching to a new sample.......................................................................................................... 53

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Copyright © 2021 CellDynamics. All rights reserved.
No part of this User Manual may be reproduced, stored in a retrieval system, transmitted, published, or distributed in
any form or by any means, electronically, mechanically, by photocopying, microfilming, recording, or otherwise, without
the prior written consent of CellDynamics.
However, notwithstanding the foregoing, the owners of the W8 Instrument may make copies solely for purposes of
training personnel in the use of the unit within their business or organization.
Maximal care has been taken by CellDynamics in the preparation of this User Manual. However, CellDynamics shall not
be liable for any technical or editorial errors or omissions contained herein or for incidental or consequential damages
in connection with the furnishing, performance, or use of this document. The information in this document are provided
“as is” without warranty of any kind, and they are subject to change without notice.
All other trademarks mentioned in this document are the property of their respective owners and are used for
identification purposes only. Unless otherwise specifically indicated, CellDynamics products and services are for
research use only and not for therapeutic or diagnostic use.
Revision Date:
June 8th, 2021

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Limited warranty
● The W8 Physical Cytometer Unit is warranted for 12 months from the date of delivery.
● The appropriate use of the device is specified in the W8 Physical Cytometer User Manual.
● If damage is due to the misuse of the W8 Physical Cytometer, all warranties shall be void. This includes
damage to the device itself as well as any consequential damages.
● Warranties are void if the damage is due to the use of analysis solutions that are not produced and/or
distributed by CellDynamics or its official commercial partners and/or distributors. This includes damage to
the device itself as well as any consequential damages.
● Under all circumstances, liability is limited to the value of the W8 Physical Cytometer. Any liability beyond
the value is excluded.
If the product proves defective during the warranty period, CellDynamics could decide one of the following
options:
(1) provide specialized technicians to repair the product at no charge for parts or labor;
(2) replace the product with a comparable product which may be new or refurbished;
(3) refound the re-evaluated value of the product based on the paid amount and the product condition.
To obtain service under this warranty the Customer must notify CellDynamics Support or its authorized
service representative of the encountered defect before the expiration of the warranty period.
In the maintenance of the product, CellDynamics may use new or equivalent-to-new parts, assemblies or
products for equal or improved quality. All defective parts, assemblies, and products become the property
of CellDynamics.
CellDynamics may require the return of parts, assemblies and products to a designated CellDynamics Depot
or the CellDynamics representative from which the part, assembly, or product was originally purchased.
Return and claims will be handled according to the current CellDynamics procedure.
These warranties shall not apply to any defect, failure or damage caused by improper use or inadequate
maintenance and care, done by personnel not authorized by CellDynamics.

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EC DECLARATION OF CONFORMITY
Referring to the Directive 2006/42/CE II.A on machinery, and amending Directive
DECLARATION IN THE ORIGINAL LANGUAGE
We: CellDynamics i.s.r.l.
Via Villa Clelia 62/d
40026 IMOLA (BO) - ITALIA
as manufacturer of the product, declare that the machine:
Physical cytometer for the analysis of mass density, size, shape of samples comprised between
50 and 500 μm:
MODEL : __W8 Physical Cytometer______
REFERENCE CODE: __W8-
FABRICATION YEAR: ___2020______
to which this declaration refers complies with the following legislative provisions:
- DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17
May 2006 on machinery, and amending Directive 95/16/EC (recast)
- DIRECTIVE 2014/30/UE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26
February 2014 on the harmonization of the laws of the Member States relating to electromagnetic
compatibility (recast)
- DIRECTIVE 2011/65/UE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8
June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic
equipment (recast)
The machine also complies with the provisions of the following harmonized standards :
EN ISO 12100:2010
Machinery safety - General design principles - Risk assessment and risk reduction
EN 61326-1:2013
Electrical equipment for measurement, control and laboratory - Electromagnetic
compatibility requirements

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1. Warnings and precautions
The instrument is conceived for safe use when the installation and operation procedures are
executed properly and in accordance with the instructions described in the present User Manual.
This section describes potential risks related to the installation and usage of this instrument and its software.
Moreover it provides guidelines and crucial safety information with the aim to avoid and/or minimize such
risks.
Follow the instructions carefully to prevent potential dangers and to protect yourself, others, and the
equipment. This instrument must be used only as specified by the manufacturer.
The safety instructions described in this document are considered as an implementation of the laboratory
policies, and local working area safety directives, in which the instrument is located, as well as standards for
health, safety and prevention of accidents.
Local authorities can provide safety details on the installation and operation of electrical power supply,
building constructions and maintenance for the correct placement of the device.
The W8 Physical Cytometer is for Research Use Only, not for use in Diagnostic Procedures.
A summary of the main concepts and procedures described in this User Manual, including the most
common issues that the operator may encounter while using the instrument (Troubleshooting), is available
on the attached QUICK START GUIDE document.
1.1.Intended use of the instrument
The W8 Physical Cytometer is conceived and tested for measuring the mass density, size and weight of
sphere-like samples (i.e. spheroids, organoids, organic or hybrid microparticles, etc.). Moreover, the
instrument is able to discriminate such samples based on the selected mass density or diameter range by the
operator. The instrument can operate for samples having sizes comprised between 50 and 500 micrometers
(μm) in diameter. Samples must be handled, introduced into the instrument, measured and sorted by
following the procedures described in this User Manual.
1.2.Limitations
DO NOT use the instrument for samples outside of the indicated size range of 50 - 500 μm in diameter.
Samples bigger than 500 μm may cause clogging of the fluidic system and lead to instrument malfunctions.
Samples smaller than 50 μm will prolong the analysis time and they are not accurately detectable. Moreover,
they may persist into the fluidic system even after the cleaning protocol, leading to biological contaminations
overtime.
DO NOT use nanosized materials or materials that can interact with Silicon or Poly(methyl methacrylate)
(PMMA). This can ruin or contaminate the internal fluidic system, as well as creating malfunctionsor leakages
over time.