Integra D-ONE 4531 User manual

D-ONE Single Channel Pipetting Modules Operating Instructions
128961_V00
for ASSIST PLUS

www.integra-biosciences.com
Declaration of conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the devices
comply with:
Description Models
D-ONE Pipetting
Module
4531, 4532
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
1103/2010 Capacity labelling of portable batteries 30.11.2010
EU Standards Scope
EN 9001:2015 Quality Management
EN 61010-1:2010 Safety general laboratory equipment
EN 61326-1:2013 Electromagnetic compatibility laboratory equipment
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 63000:2018 Restriction of hazardous substances (RoHS)

INTEGRA Biosciences AG
D-ONE – Declaration of conformity
Zizers, September 10, 2021
USA Regulations Scope Date effective
47 CFR Part 15 (FCC)
Electromagnetic compatibility (EMC)
17 CFR Parts 240 & 249b Dodd frank “Conflict minerals”
27 CCR Parts 25102-
27001
Proposition 65: The safe drinking water and
toxic enforcement 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
CHN Regulations Scope Date effective
Order 32/2016 Restriction of hazardous substances (RoHS) 01.07.2016
CHN Standards Scope
SJ/T 11364-2014 Restriction of hazardous substances (RoHS)
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
Thomas Neher
Quality Manager

4 INTEGRA Biosciences AG
D-ONE – Operating instructions V00
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 Toolbox - adapt your D-ONE module .............................................15
3.4.1 Preferences.........................................................................16
3.4.2 Calibration & Service ..........................................................17
3.4.3 Communications .................................................................18
3.4.4 Device Information ..............................................................19
3.4.5 Language ............................................................................19
3.4.6 Write protect........................................................................20
Chapter 4 Operation
4.1 Turn on/off the device.....................................................................21
4.2 Programming..................................................................................21
4.3 Running a program.........................................................................21
4.4 Troubleshooting/FAQ .....................................................................22
4.4.1 General ...............................................................................22
4.4.2 Electronic ............................................................................23

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D-ONE – Operating instructions V00
Chapter 5 Maintenance
5.1 Maintenance schedule ...................................................................24
5.1.1 Daily ....................................................................................24
5.1.2 Periodical ............................................................................24
5.1.3 Yearly Maintenance ............................................................24
5.2 Cleaning .........................................................................................24
5.3 Decontamination ............................................................................25
5.4 Leak test.........................................................................................25
5.5 Servicing.........................................................................................26
5.5.1 Shipping to INTEGRA Biosciences.....................................26
5.5.2 Changing O-rings of tip fittings............................................27
5.6 Equipment disposal ........................................................................27
Chapter 6 Technical data
6.1 Environmental conditions ...............................................................28
6.2 Specification of the device..............................................................28
6.3 Pipetting speed...............................................................................29
6.4 Intellectual Property........................................................................30
6.5 D-ONE Specifications.....................................................................31
Chapter 7 Accessories
7.1 Accessories ....................................................................................32
7.2 Consumables .................................................................................32
7.3 GripTips..........................................................................................36
7.3.1 INTEGRA pipetting device ..................................................36
7.3.2 Package options .................................................................36
7.3.3 GripTip properties ...............................................................36

D-ONE – Operating instructions V00
6 INTEGRA Biosciences AG
Imprint
© 2022 INTEGRA Biosciences AG
All rights to this documentation are reserved. In particular the rights of reproduction,
processing, translation and the form of presentation lie with INTEGRA Biosciences AG.
Neither the complete documentation nor parts thereof may be reproduced in any way, or
stored and processed using electronic media or distributed in any other way without the
written consent of INTEGRA Biosciences AG.
This operating instruction manual has part number 128961, the version is V00. It applies
as of (see Toolbox - Device information):
of D-ONE single channel pipetting modules until a newer revision is released.
VIALAB and GripTip are trademarks of INTEGRA Holding, Switzerland.
Manufacturer
Customer service
Please contact your local INTEGRA Biosciences representative.
To find out name and address go to www.integra-biosciences.com.
Further information and operating instructions in other languages are available on
www.integra-biosciences.com or on request [email protected].
Serial number 7 000000 or higher
(Firmware) FW version 5.01 or higher
INTEGRA Biosciences AG
CH-7205 Zizers, Switzerland
T [phone]
F [phone]
INTEGRA Biosciences Corp.
Hudson, NH 03051, USA
T [phone]
F [phone]
[email protected]
www.integra-biosciences.com

D-ONE – Operating instructions V00 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 V00 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 V00 Introduction
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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 V00 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.

D-ONE – Operating instructions V00 Description of the device
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2.2 Overview of D-ONE module
2.2.1 Module parts
1Display
2Back button, to navigate backward
3Touch wheel, spin to scroll and move the cursor
4OK button, to make a selection
5Left and right arrow buttons, for selections
6PURGE button, to empty GripTips, for calibration
only
7RUN button, to start operations
8Tip ejector
9Finger hook
10 Volume indicator label (purple/green or yellow/
blue), colors match GripTip rack inserts
11 Tip ejector
12 Tip fittings, for 0.5/300 µl or 5/1250 µl GripTips
2
5
6
7
8
3
4
9
10
1
11
12

D-ONE – Operating instructions V00 Description of the device
12 INTEGRA Biosciences AG
2.2.2 Back view
2.2.3 Display
The Display shows under ASSIST PLUS all available VIALAB programs.
13 Power connector
14 Reset button
15 Communication/charging cable interface
16 Battery
Battery life indicator
select a
VIALAB
Program
Instruction
Options
14 13
15
16
K
Program Name
OK
OK

D-ONE – Operating instructions V00 Description of the device
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2.2.4 Touch wheel
The touch wheel is fully operational with only one hand. Rotational finger movements
translate into up and down cursor movement on the display. The touch wheel is fully
functional with the use of latex gloves.
2.2.5 PURGE button (only calibration)
During pipetting, you can interrupt the current pipetting protocol and purge all remaining
liquid currently in the GripTips. To do so, press PURGE (6).
2.2.6 RUN button (only calibration)
Press and release the RUN button (7) to initiate pipetting operations. This button is
centrally located for left- or right-handed actuation.
During dispense, you can press and hold RUN to perform a two-step blowout, see “4.4
Troubleshooting/FAQ” on page 22.
2.2.7 Tip ejector
The Tip Ejector easily ejects tips from the tip fitting.
2.2.8 Reset button
The reset button (13) is located on the back of D-ONE. It is used to reset the RAM in the
module. The programs stored in memory are maintained. Once pressed, the startup
screen will be displayed.
Press any key to continue and allow the instrument to initialize and home. The routine
ends by displaying the Main Menu.
The module will display a prompt:
To proceed, press and release RUN (7). Upon completion of the
dispense, the first step in the current program will be displayed.
The serial number can be found beneath the tip ejector. Press and
hold the tip ejector in the down position to see the 7-digit serial
number.

D-ONE – Operating instructions V00 Installation
14 INTEGRA Biosciences AG
3 Installation
3.1 Operating environment
The D-ONE have been designed for use in a laboratory. They shall be operated in a dry
and dust-free location with a temperature of 5– 40 °C and a maximal (non-condensing)
relative humidity of 80 %.
3.2 Charging the battery
D-ONE contains a rechargeable Li-ion battery. Charge the battery completely before first
use. A full charge takes 2.5 hours (max. 4 hours) and will provide approximately 1500
cycles.
A battery indicator is provided on D-ONE display (2.2.3) indicating different states:
• Blinking red icon: Battery is low and needs to be recharged. If not connected to the
mains adapter, the D-ONE module will turn off soon.
• Green icon: D-ONE module is connected to the mains adapter.
• Blinking bars: D-ONE module is recharging.
• Two static and one blinking bar on the right: D-ONE module is recharging and battery
is 80% charged.
• Three static bars: Battery is fully charged.
Use the charging/communication stand (#4211), the USB cable (#4226) or the charging
cable (#4549) to charge the battery, see “7.1 Accessories” on page 32).
CAUTION
Use only the approved INTEGRA battery, charging cable or stand with the
correct mains adapter. Use of an incompatible power transformer can
damage the D-ONE module.
The D-ONE module will turn on when placed on the stand and turn off when the Turn Off
Time is reached. The display may dim or show the start up screen, but it will continue to
show the battery life indicator. When the Standby Time is reached, the display is turned
off. When the Turn Off Time is reached, the instrument will shut off.
For disconnecting simply lift the D-ONE module up from the stand.
Place the D-ONE module on the charging/communication stand by
fitting the power receptacle (15, on the top back of the module) over
the four pin prong connector on the top of the stand.
Plug the power cable of the adequate power supply to the socket.

D-ONE – Operating instructions V00 Installation
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3.3 Exchanging the battery
After exchanging the battery, a protective switch is active. The D-ONE module can only
be started after connecting it to the mains power supply.
WARNING
D-ONE module use Li-ion batteries, see “1.3 Safety notes” on page 8.
3.4 Toolbox - adapt your D-ONE module
The Toolbox provides options to adapt the device to appropriate applications, setting
personal preferences, calibration, computer connectivity and storing device information.
Help information is available for each mode.
To exchange the battery, loosen the screw to detach the D-ONE
module backing. Disconnect the power plug of battery (16).
Connect the power plug of the new battery to the D-ONE module's
socket and reassemble the D-ONE module backing.
Toolbox mode Description
ASSIST PLUS Programs available in combination with ASSIST PLUS.
Preferences Customizes the system parameters.
Calibration & Service Sets calibration and service history options.
Communications Enables communication between your D-ONE module and a
PC.
Device Information View your D-ONE module’s serial number and set a personal ID.
Language Sets language.
Write Protect Protects programs or menu options from modification.
Time/Date Sets current time and date.

D-ONE – Operating instructions V00 Installation
16 INTEGRA Biosciences AG
3.4.1 Preferences
Preferences customizes your system parameters. Select a preference and press OK to
access.
After changing desired settings, press to save.
Preference Description Range
Sound Simple tones indicate completion of operations and
errors. Select an option and press OK to change the
status of the beep tone between On and Off:
•Program Complete: At program completion
•PURGE button: When PURGE is pressed.
•Messages: When a message appears.
•Error Message: When an error message appears or
when illegal data entry is attempted.
•Touch Wheel: When using the touch wheel.
/
(On/Off)
Display Customizes your display. Press OK to select an option,
use the touch wheel to display the desired value.
•Start up Screen: Select the startup display at one of
the following: None or Custom (up to two, uploaded
with VIALINK). Press to save your selection.
•Brightness: Use the touch wheel to change the
brightness: 1 (dim) to 10 (bright). Press OK.
•Dim Time: The display will dim after a set number of
minutes. A shorter dim time helps preserve battery
life. Press OK to save your selection.
•Standby Time: The display will turn off after a set
number of minutes and allows you to continue work-
ing where you have left. A shorter standby time helps
preserve battery life.
•Turn Off Time: The D-ONE module will turn off after
a set number of hours. You can change this setting.
Press OK to save your selection.
None,
Custom 1 or 2
1-10
Never,
1-20 min
5-60 min
(default 5 min)
1-24 hours
(default 8 h)
Touch
Wheel
Adjust your touch wheel sensitivity. Press to save. Low, Medium,
High

D-ONE – Operating instructions V00 Installation
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3.4.2 Calibration & Service
These options enable you to set calibration features, review service history and check the
number of pipetting moves performed.
Calibration
& Service Description Range
Calibration Allows for re-calibration of the D-ONE module to restore
accuracy (calibration has to be performed by INTEGRA).
Choose the channel. The calibration factors for Pipette
and Repeat type are displayed.
To edit the calibration volumes, press Edit.
•Target Volume: This is the volume you are interested
in using for the calibration.
•Actual Volume: This is the measured volume
obtained when dispensing the target volume.
•Current Factor: Displays the factor currently in use.
•Factory Reset: Resets the correction factor back to
the original factory setting. Press to apply the
factory setting.
-
Calibration
Reminder
Time or
Cycles
Sets a calibration reminder based on a specified time
frame or number of pipetting cycles. When the calibration
reminder is displayed, press any key to confirm.
However, the reminder will reappear every time the D-
ONE module is turned on until you change the reminder
time or use the reset option.
•Reminder: Press OK to turn the reminder timer On or
Off.
•Days/Cycles: Use the touch wheel to set a reminder
interval for calibration (time in days or in thousands of
cycles). Press to set the timer to the defined cali-
bration interval.
•Remind in/Total Cycles: Displays the residual time
or amount of cycles respectively before calibration is
required.
•Reset: Resets the timer to the defined calibration
interval. Press to enable.
Press to save.
/
(On/Off)
1-365 days
or 1k - 240k
cycles
Service
History
Displays notes of any service that took place on the D-
ONE module listed newest entry first.
-

D-ONE – Operating instructions V00 Installation
18 INTEGRA Biosciences AG
After changing desired settings, press to save.
3.4.3 Communications
D-ONE must be programmed from a PC via a charging/communication stand (#4211), the
USB cable #4226 or charging/communication station for linear stand (#3218).
VIALAB is a pipetting automation software for the PC. It allows to create automated
pipetting programs for a variety of applications on ASSIST PLUS. It can be downloaded
from the INTEGRA website in the product section. A detailed description of the software,
along with the operating instructions, can be found on the website as well.
Select one connection type and press OK to allow communication with the PC. VIALAB
will detect the D-ONE module automatically.
Move
Counter
Displays the number of completed moves.
• Piston Moves: One piston move is defined as one full
start and stop cycle of the piston.
• Y Moves: One tip spacing move is defined as one full
start and stop cycle of the spacing motor.
-
Communi-
cations Description
USB Place the D-ONE module on a charging/communication stand (#4211), or
connect the device to the USB cable (#4226) and connect it to the USB
port of your PC.
ComModule Each pipette needs its own pipette communication module (#4221).
Using the communication module enables a communication with an open
field connectivity of about 10 meters. If a paring code is required: 12345.
Via ASSIST
PLUS
Activate this communication for live position teaching on ASSIST PLUS.
ASSIST PLUS needs to be connected with USB to the PC.
PC Control
(A+)
To control the pipette by an external device, e.g. laptop or PC. This allows
to start a VIALAB program directly from VIALAB itself.
Calibration
& Service Description Range

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3.4.4 Device Information
This menu displays information about your D-ONE module, such as volume range,
number of channels, serial number, firmware (FW) and hardware (HW) version.
Go to the next pages with Next .
3.4.5 Language
Device
Information Description
Edit Owner • Press Edit Owner to enter the user name for your D-ONE module.
Use the touch wheel to highlight a character and press OK. You can
press to Delete the last character entered. After entering the
desired text, press to Save.
The last page displays the compliance screen, which is also shown
during start up. It lists the standards the D-ONE modules comply with.
Language Description
Language You can choose the language in which all screens are displayed. Scroll to
the desired language, press OK and to Save.

D-ONE – Operating instructions V00 Installation
20 INTEGRA Biosciences AG
3.4.6 Write protect
Select this option to protect programs and menu options from inadvertent modification.
The pipetting programs can still be used.
Keep the password in a safe place. Should you lose your password, contact
INTEGRA Biosciences for assistance in retrieving it.
Write
Protect Description Range
Select an option and press OK to switch protection on or
off:
•Custom Programs
•Password Protection: Protect the access to the
write protect menu by selecting “”.
•Edit Password, if password protect is switched on.
To enter a password use the touch wheel to highlight
a character and press OK. Press to save the pass-
word. The password must be entered before you can
access the write protect menu.
/
On/Off