Integra VIAFLO 4011 VIAFLO 4012 User manual

D-ONE Single Channel Pipetting Modules Operating Instructions
128966_V01
for ASSIST PLUS

i/iii INTEGRA Biosciences AG
Declaration of conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the devices
comply with:
Description Models
VIAFLO Pipettes 4011, 4012, 4013, 4014, 4015, 4016, 4621, 4622, 4623, 4624,
4626, 4631, 4632, 4633, 4634, 4636, 4641, 4642, 4646
VOYAGER Pipettes 4721, 4722, 4723, 4724, 4726, 4731, 4732, 4736, 4743, 4744,
4763, 4764
D-ONE Module 4531, 4532
Accessories 3214, 3215, 3216, 3217, 3218, 4200, 4205, 4210, 4211, 4215,
4221
EU Directives Scope Date effective
2014/35/EU Low voltage directive (LVD) 20.04.2016
2014/30/EU Electromagnetic compatibility (EMC) 20.04.2016
2012/19/EC
Waste electrical and electronic equipment (WEEE) 14.02.2014
2011/65/EC Restriction of hazardous substances (RoHS) 03.01.2013
2006/66/EC Battery directive 26.09.2008
EU Regulations Scope Date effective
1907/2006
Registration, evaluation, authorisation and
restriction of chemicals (REACH)
01.06.2007
2019/1782 External power supply efficiency 01.04.2020
1103/2010 Capacity labelling of portable batteries 30.11.2010
EU Standards Scope
EN 9001:2015 Quality Management
EN 61010-1:2020 Safety general laboratory equipment
EN 61326-1:2013 Electromagnetic compatibility laboratory equipment
EN 60950-1:2013 Safety information technology equipment
EN 62368-1:2021 Safety information technology equipment
EN 62133-2:2017 Batteries containing non-acid electrolytes

www.integra-biosciences.com ii/iii
VIAFLO/VOYAGER/D-ONE – Declaration of conformity
GBR Regulations Scope Date effective
S.I. 2016/1101
Electrical equipment safety 08.12.2016
S.I. 2016/1091 Electromagnetic compatibility (EMC) 08.12.2016
S.I: 2008/2164 Batteries and accumulators regulations 26.09.2008
S.I. 2013/3113
Waste electrical and electronic equipment (WEEE) 01.01.2019
S.I. 2012/3032 Restriction of hazardous substances (RoHS) 02.01.2013
GBR Standards Scope
BS 61010-1:2010 Safety general laboratory equipment
BS 62368-1:2020 Safety information technology equipment
BS 63000:2018 Restriction of hazardous substances (RoHS)
USA Regulations Scope Date effective
47 CFR Part 15 (FCC)
Electromagnetic compatibility (EMC)
10 CFR Part 430 External power supply efficiency (CEC VI)
17 CFR Parts 240 & 249b Dodd frank “Conflict minerals”
27 CCR Parts 25102-
27001
Proposition 65: The safe drinking water and
toxic enforcement act
TSCA 40 CFR Part 751 Toxic substances control act
20 CCR Parts 1601-1608
CEC BCS, Battery charging efficiency 01.01.2017
USA Standards Scope
UL 61010-1:2012 Safety general laboratory equipment
CAN Standards Scope
CSA-C22.2
No. 61010-1
Safety general laboratory equipment

iii/iii INTEGRA Biosciences AG
VIAFLO/VOYAGER/D-ONE – Declaration of conformity
Zizers, May 2, 2022
CHN Regulations Scope Date effective
AQSIQ Order 5 /2001 (CCC) safety and EMC requirements for
electrical equipment
01.08.2003
Order 32/2016 Restriction of hazardous substances (RoHS) 01.07.2016
CHN Standards Scope
GB4943.1-2011 Information technology equipment safety
GB9254-2008 Information technology equipment radio
disturbance
GB17625.1-2012 EMC limits for harmonic current emissions
GB31241-2014 Safety for Lithium-ion batteries
SJ/T 11364-2014 Restriction of hazardous substances (RoHS)
JPN Regulations Scope Date effective
PSE (Denan) Law
Electrical appliance and material safety law 01.01.2014
EAC Технический регламент Таможенного союза
ТР ТС 004/2011 О
безопасности низковольтного оборудования
ТР ТС 020/2011 Электромагнитная совместимость технических средств
International Standards
ISO 8655-2 Piston pipettes
Urs Hartmann
CEO
Daniel Bächi
Head of Corporate Quality

www.integra-biosciences.com 5
D-ONE – Operating instructions V01
Table of Contents
Chapter 1 Introduction
1.1 Symbols used...................................................................................7
1.2 Intended use.....................................................................................7
1.3 Safety notes .....................................................................................8
Chapter 2 Description of the device
2.1 Scope of delivery............................................................................10
2.2 Overview of D-ONE module ...........................................................11
2.2.1 Module parts .......................................................................11
2.2.2 Back view............................................................................12
2.2.3 Display ................................................................................12
2.2.4 Touch wheel........................................................................13
2.2.5 PURGE button (only calibration).........................................13
2.2.6 RUN button (only calibration)..............................................13
2.2.7 Tip ejector ...........................................................................13
2.2.8 Reset button........................................................................13
Chapter 3 Installation
3.1 Operating environment...................................................................14
3.2 Charging the battery.......................................................................14
3.3 Exchanging the battery...................................................................15
3.4 Tip deck for D-ONE ........................................................................15
3.5 Toolbox - adapt your D-ONE module .............................................16
3.5.1 Preferences.........................................................................17
3.5.2 Calibration & Service ..........................................................18
3.5.3 Communications .................................................................19
3.5.4 Device Information ..............................................................20
3.5.5 Language ............................................................................20
3.5.6 Write protect........................................................................21
Chapter 4 Operation
4.1 Turn on/off the device.....................................................................22
4.2 Programming..................................................................................22
4.3 Running a program.........................................................................22
4.4 Troubleshooting/FAQ .....................................................................23
4.4.1 General ...............................................................................23
4.4.2 Electronic ............................................................................24

6 INTEGRA Biosciences AG
D-ONE – Operating instructions V01
Chapter 5 Maintenance
5.1 Maintenance schedule ...................................................................25
5.1.1 Daily ....................................................................................25
5.1.2 Periodical ............................................................................25
5.1.3 Yearly Maintenance ............................................................25
5.2 Cleaning .........................................................................................25
5.3 Decontamination ............................................................................26
5.4 Leak test.........................................................................................26
5.5 Servicing.........................................................................................27
5.5.1 Shipping to INTEGRA Biosciences.....................................27
5.5.2 Changing O-rings of tip fittings............................................28
5.6 Equipment disposal ........................................................................28
Chapter 6 Technical data
6.1 Environmental conditions ...............................................................29
6.2 Specification of the device..............................................................29
6.3 Pipetting speed...............................................................................30
6.4 Intellectual Property........................................................................31
6.5 D-ONE Specifications.....................................................................32
Chapter 7 Accessories
7.1 Accessories ....................................................................................33
7.2 Consumables .................................................................................33
7.3 GripTips..........................................................................................37
7.3.1 INTEGRA pipetting device ..................................................37
7.3.2 Package options .................................................................37
7.3.3 GripTip properties ...............................................................37
Imprint ...................................................................................................38

D-ONE – Operating instructions V01 Introduction
www.integra-biosciences.com 7
1 Introduction
These operating instructions contain all the information required for installation, operation
and maintenance of the D-ONE modules. This chapter informs about the symbols used in
these operating instructions, the intended use of D-ONE and the general safety
instructions.
1.1 Symbols used
The operating instructions specifically advise of residual risks with the following symbols:
WARNING
This safety symbol warns against hazards that could result in injury. It also
indicates hazards for machinery, materials and the environment.
It is essential that you follow the corresponding precautions.
CAUTION
This symbol cautions against potential material damage or the loss of data in
a microprocessor controller. Follow the instructions.
NOTE
This symbol identifies important notes regarding the correct operation of the
device and labor-saving features.
1.2 Intended use
This is a general-purpose laboratory instrument for use in research only. Any use of this
instrument in a medical or IVD setting is under the sole responsibility of the user.
This product may only be operated in a secure, protected network with validated,
trustworthy clients. The operator must ensure that network security measures are always
up-to-date and state-of-the-art. This product may not be directly exposed to the internet.
If the D-ONE modules are used in a manner not specified by INTEGRA Biosciences, the
protection provided by the D-ONE may be impaired.
D-ONE are microprocessor controlled and stepper motor driven pipetting modules with
two channels, one of which can be used at a time. They are used on the ASSIST PLUS
pipetting robot for aspirating and dispensing aqueous liquids in the volume range of 0.5 –
1250 μl using GripTip™ pipette tips only. Each D-ONE module is compatible with two
different GripTip sizes and provides pressure-based liquid level detection.

D-ONE – Operating instructions V01 Introduction
8 INTEGRA Biosciences AG
1.3 Safety notes
D-ONE comply to the recognized safety regulations and are safe to operate. D-ONE
should only be operated when in perfect condition and while observing these operating
instructions.
The device may be associated with residual risks if it is used or operated improperly by
untrained personnel. Any person operating D-ONE must have read and understood these
operating instructions, and particularly, the safety notes, or must have been instructed by
supervisors so that safe operation of the device is guaranteed.
WARNING
• Use only an original INTEGRA Li-ion battery (#4205) and charging
device.
• Old Li-ion batteries may cause a safety risk. We recommend to replace
the battery after 3 years of use. Also replace the battery if the charging
intervals are unusually short or if the charging takes much longer than
usual (4 hours or more). – These are indicators that the battery has
reached the end of its life-cycle.
If a lithium battery is never deep discharged and is always stored and
operated in the recommended temperature range and stored at 40-80%
charge level during long standby periods, it may live much longer than 3
years. If it shows no signs of physical damage or change, see 5.1.3, it is
a strong indication that you may continue to use the battery.
• Li-ion technology bears the risk of thermal runaway and cell rupture if the
battery was damaged. Do not expose the battery to heat (> 60°C) and
avoid mechanical stress. Batteries which were subject to deep dis-
charges may develop internal short circuits, leading to an increased self-
discharge rate and heating during battery charging. This may also result
in thermal runaway and cell rupture.
CAUTION
• To extend the battery life-cycle, it is recommended to charge the battery
every 2 months if D-ONE is not used regularly. If D-ONE is not used for
more than 6 months, unplug the battery.
WARNING
•Do not use D-ONE near flammable material or in explosive areas. Also,
do not pipette highly flammable liquids such as acetone or ether.
• When handling dangerous substances, comply with the material safety
data sheet (MSDS) and with all safety guidelines such as the use of pro-
tective clothing and safety goggles.

D-ONE – Operating instructions V01 Introduction
www.integra-biosciences.com 9
CAUTION
•Do not immerse D-ONE in liquid. The fluid can damage internal parts.
Avoid pipetting of liquids whose vapors could attack the materials PA
(polyamide), POM (polyoxymethylene), FPM (fluor-rubber), NBR (nitrile-
rubber), CR (chloroprene), silicone. Corrosive vapors could also damage
metallic parts inside the device.
• Do not modify D-ONE in any way. Repairs may only be performed by
INTEGRA Biosciences or by an authorized after-sales service member.
• Parts may be replaced with original INTEGRA Biosciences parts only.
NOTE
Prolonged exposure of D-ONE to UV-light can cause discoloration and/or
yellowing of D-ONE housing. However, this will not affect the performance of
the device in any way.
Regardless of the listed safety notes, additional applicable regulations and guidelines of
trade associations, health authorities, trade supervisory offices, etc. must be observed.
Please visit our website www.integra-biosciences.com on a regular basis for up to date
information regarding REACH classified chemicals contained in our products.

D-ONE – Operating instructions V01 Description of the device
10 INTEGRA Biosciences AG
2 Description of the device
2.1 Scope of delivery
• D-ONE single channel pipetting module
• Rechargeable battery (located inside the module, Li-ion, 3.7 V, 1050 mAh)
• Bag of spare O-rings
• O-ring removal tool
• Certificate of performance
• Trial pack 25 ml SureFlo™ reagent reservoir
• Quick start guide
CAUTION
Verify the scope of delivery when unpacking the device and check for
potential transportation damage. Do not operate a device that is damaged,
instead contact your local INTEGRA representative.
NOTE
The pipette communication module (#4221) is mandatory to use the D-ONE
module with the ASSIST PLUS and has to be ordered separately.