Analytic Jena InnuPure C16 User manual

InnuPure C16
Extraction system
Operating manual

Manufacturer
CyBio AG
Goeschwitzer Strasse
07745 Jena
Germany
Phone:
Hotline: + 49 (0) 3641 / 351-0
Fax: + 49 (0) 3641 / 351-409
Email:
[e-mail]
Service:
Analytik Jena AG
Life Science
Konrad
-Zuse-Str. 1
07745 Jena
Germany
Phone:
Hotline: + 49 (0) 3641 / 77-94 11
Fax: + 49 (0) 3641 / 77-76 77 76
Email:
[e-mail]
General information about Analytik Jena AG
on the internet: http://www.analytik-jena.de
Copyrights and Trademarks
Microsoft and Windows are registered trademarks of Microsoft Corp.
The identification with ® or TM is omitted in this manual.
Documentation number: 30-7115-002-23
Edition – June 2016
Implementation of the Technical Documentation:
Analytik Jena AG
This publication describes the state of this product at the time of publishing. It need not necessarily
agree with future versions of the product.
Modifications reserved!
© Copyright 2016 Analytik Jena AG

Contents
InnuPure C16 Edition 06/2015 1
Contents
1Basic information ........................................................................................................ 5
1.1 User manual notes .............................................................................................. 5
User manual conventions.................................................................................... 5
1.2 Intended use........................................................................................................ 5
1.3 Warranty and liability........................................................................................... 6
2Technical data.............................................................................................................. 7
3Safety instructions ...................................................................................................... 9
3.1 General notes...................................................................................................... 9
3.2 Symbols and signal words used in the user manual........................................... 9
3.3 Safety markings on the InnuPure C16 .............................................................. 10
3.4 Technical condition............................................................................................ 11
3.5 Requirements for the operating personnel........................................................ 11
3.6 Safety instructions, transport and installation.................................................... 11
3.7 Safety instructions - operation........................................................................... 12
3.8 Handling hazardous substances....................................................................... 12
3.9 Chemical resistance of the device..................................................................... 13
3.10 Behavior during emergencies............................................................................ 13
3.11 Standards and directives................................................................................... 14
4Technical description................................................................................................ 15
4.1 Basic system design.......................................................................................... 15
4.2 Design, connections, indications....................................................................... 15
4.3 Principle of operation......................................................................................... 19
5First commissioning.................................................................................................. 22
5.1 Site requirements .............................................................................................. 22
5.1.1 Installation conditions........................................................................................ 22
5.1.2 Space requirement............................................................................................ 22
5.1.3 Energy supply.................................................................................................... 23
5.2 Connecting the InnuPure C16 and switching it on/off ....................................... 23
Connecting the InnuPure C16........................................................................... 23
Switching on the InnuPure C16......................................................................... 23
Switching off the InnuPure C16......................................................................... 24
Switching off the touch sensor .......................................................................... 24
6Operation.................................................................................................................... 25
6.1 Preparation of the buffers and solutions............................................................ 25
6.2 Preparing the sample trays and inserting them into the InnuPure C16 ............ 25
6.3 Operating InnuPure C16 with HID-Pro 320....................................................... 29
6.3.1 Overview of the InnuPure C16 program............................................................ 29

Contents
2 Edition 06/2015 InnuPure C16
6.3.2 Starting and executing an extraction protocol ................................................... 30
6.3.3 Copying, moving or deleting extraction protocols.............................................. 34
6.3.4 Checking and executing individual device functions with tools......................... 36
6.3.5 Using the sample setup tool .............................................................................. 37
Creating and saving a sample setup via the HID-Pro 320 ................................ 37
Creating a sample setup via an external PC..................................................... 39
Loading a sample setup via the HID-Pro 320.................................................... 41
6.3.6 Recording, downloading and displaying logfiles................................................ 42
Recording logfiles.............................................................................................. 42
Downloading logfiles to a USB stick.................................................................. 42
Viewing logfiles.................................................................................................. 42
6.3.7 Working with user management........................................................................ 44
User rights ......................................................................................................... 44
Creating/changing/deleting a user profile.......................................................... 45
Switching user login at start on/off..................................................................... 46
Logging in a different user................................................................................. 46
6.3.8 Enabling the interior light and the touch sensor................................................ 46
6.3.9 Configuring the time .......................................................................................... 47
7Fault removal.............................................................................................................. 48
7.1 Error messages ................................................................................................. 48
7.2 General information and tips for preventing problems ...................................... 49
8Maintenance and care ............................................................................................... 51
8.1 Cleaning the InnuPure C16............................................................................... 51
8.2 Changing fuses.................................................................................................. 52
8.3 Software update................................................................................................. 53
9Transport and storage............................................................................................... 54
9.1 Transport ........................................................................................................... 54
9.1.1 Preparing the device for transport..................................................................... 54
9.1.2 Transport notes.................................................................................................. 57
9.1.3 Moving the device in the laboratory................................................................... 57
9.2 Storage .............................................................................................................. 58
10 Disposal...................................................................................................................... 59
11 EC Declaration of Conformity................................................................................... 60

Figures
InnuPure C16 Edition 06/2015 3
Figures
Figure 1 Safety symbols at the front and rear of the InnuPure C16 .................................. 10
Figure 2 Front view of the InnuPure C16........................................................................... 16
Figure 3 Rear connections and switches at the InnuPure C16.......................................... 16
Figure 4 Device view with open front door......................................................................... 17
Figure 5 Sample tray.......................................................................................................... 17
Figure 6 Priming station and optionally available perforation tool ..................................... 18
Figure 7 HID-Pro 320......................................................................................................... 18
Figure 8 Start window......................................................................................................... 24
Figure 9 Program overview of the InnuPure C16............................................................... 29
Figure 10 Assignment of the sample positions .................................................................... 37
Figure 11 Empty sample setup in the PC program.............................................................. 40
Figure 12 Sample setup created by PC/laptop .................................................................... 41
Figure 13 Example logfile of a demo protocol run ............................................................... 43
Figure 14 Switching the interior light/enabling the touch sensor.......................................... 46
Figure 15 Window for configuring the date and time ........................................................... 47
Figure 16 Open fuse holder.................................................................................................. 52

Figures
4 Edition 06/2015 InnuPure C16

Basic information
InnuPure C16 Edition 06/2015 5
1 Basic information
1.1 User manual notes
The InnuPure C16 is intended for operation by qualified specialist personnel observing this
user manual.
The user manual informs about the design and operation of the InnuPure C16 and provides
the personnel familiar with the isolation and purification of nucleic acid with the necessary
know-how for the safe handling of the equipment and its components. The user manual fur-
ther includes notes on the maintenance and service of the equipment and information on
potential causes and remedies of any faults.
User manual conventions
Instructions for action which occur in chronological order are numbered and combined into
action units and furnished with the corresponding results.
Lists which are not in chronological order are shown as itemized lists, sub-listings as bullet
points.
Safety notes are indicated by pictographs and signal words. The type and source of the
danger, as well as the consequences, are stated together with notes on preventing the dan-
ger. The meaning of the pictographs and signal words used is explained in the chapter
"Safety notes".
The elements of the control program are indicated as follows:
Program terms are identified with SMALL CAPS.
Buttons are shown by square brackets (e.g., [OK] button)
Menu items are separated by arrows (e.g., FILE OPEN).
1.2 Intended use
The InnuPure C16 is a flexible and efficient extraction system for the fully automated isola-
tion and purification of nucleic acid in chemical and biological laboratories. In the field of
medicine and diagnostics its use is limited to research.
The InnuPure C16 including its original accessories must only be used for the applications
described in this instruction manual. The manufacturer does not accept liability for any other
use, including that of any individual modules or components.
The device must only be operated by qualified and trained personnel.
The device must only be used in accordance with this instruction manual. This ap-
plies in particular to the adherence to the connection values, conditions of use and
notes on maintenance, service, transport and disposal.
The safety notices in this instruction manual must be observed.
It is not permissible
to work with explosive substances in this device.

Basic information
6 Edition 06/2015 InnuPure C16
to operate this device in an explosive environment.
to use consumables that are not recommended for the InnuPure C16 and the cor-
responding kits.
to use overfilled consumables.
The operator is responsible for the use of the equipment as intended.
1.3 Warranty and liability
The warranty and liability periods comply with the legal requirements and the provisions in
the general terms and conditions of Analytik Jena AG.
Deviations from the intended use described in this user manual will result in limitations of
warranty and liability in the event of a claim. Damage to wearing parts or breakage of glass
are not included in the warranty.
Warranty and liability claims are excluded for personal injury and property damage due to
one or several of the following causes:
use of the InnuPure C16 other than intended
improper commissioning, operation and servicing of the device
modifications to the equipment without prior consultation with Analytik Jena AG
unauthorized intervention in the equipment
operation of the device with faulty safety equipment or improperly fitted safety and
protection equipment
inadequate monitoring of the equipment components subject to wear
use of other than original spare parts, wearing parts or consumables
improper repairs
faults due to the non-observance of this user manual

Technical data
InnuPure C16 Edition 06/2015 7
2 Technical data
System parameters
Extraction principle based on surface-functionalized magnetic or paramagnetic parti-
cles
Extraction duration from 28 min (dependent on the source material)
Drive 5 low-noise long-life servomotors
Device operation stand-alone via HID-Pro 320 with 5.7” touchscreen (color)
Maintenance maintenance-free through the use of non-wearing stainless steel
pistons
Cleaning system components easily accessible through the front door
Temperature control heating up to 80°C
Application parameters
Consumables completely contained in the required kit
sealed, pre-filled reagent strips or plates
Lysis step automated in the device (dependent on the source material)
Extraction routines pre-installed protocols (optimized for the most varied source mate-
rials)
Piercing function removing the sealing film from the reagent strips and plates not
necessary
Cross contamination completely excluded through sealed reagent strips and plates
Tips max. 32 per preparation each with a capacity of 1000 µl
Samples
Sample capacity up to 16 preparations in parallel
processing of different source materials possible with identical pi-
petting protocols
Sample preparation pre-insertion of the pipette tips, samples and elution tubes into the
sample tray
insertion of pre-filled reagent strips/plates into the sample tray
Sample volume up to 2 ml or up to 50 mg
Elution separate storage vessels with cover
Elution volume adjustable from 20 - 500 µl or 50 – 500 µl depending on the proto-
col
Accessories and kits
Sample tray carrier for the pre-insertion of all consumables and samples
Priming station rack for easy preparation of the sample tray
Kits DNA extraction and RNA extraction from different source materials
Piercing tool(optional) tool for manually opening the strips and plates at the tip ejection
positions 1 and 3
Adapter for reagent
strips (optional) adapter for accepting a maximum of 4 reagent strips
Barcode scanner reading the sample names from barcode labels
Other technical data
Weight approx. 35 kg
Dimensions
(W x H x D) 380 mm x 435 mm x 530 mm

Technical data
8 Edition 06/2015 InnuPure C16
Electrical variables
Power supply 110 – 230 V AC, 50 – 60 Hz
Protection 2 x T 4A H 250V
Max. power consump-
tion 160 VA
PC interface USB
Interference suppres-
sion
(electromagnetic
compatibility)
interference suppression in compliance with the requirements of
BMPT Vfg. 243/1991 and EN 55022 Class A
Environmental conditions
Temperature during
operation 5 – 35 °C
Humidity during op-
eration max. 80% at +30 °C
Temperature during
storage -10 – 55 °C
Humidity during stor-
age max. 80% (use desiccant)

Safety instructions
InnuPure C16 Edition 06/2015 9
3 Safety instructions
3.1 General notes
For your own safety and to ensure error-free and safe operation of the InnuPure C16, please
read this chapter carefully before using the appliance.
Comply with all safety instructions contained in this user manual and pay careful attention to
all messages and notes which are displayed on the screen by the program.
You must also comply with the safety instructions on the labels as well as the information on
handling, storage and disposal of the kits.
Besides the safety instructions contained in this user manual and the local safety regulations
that apply to the operation of the device, the general applicable regulations regarding acci-
dent prevention, occupational health and safety and environmental protection have to be
observed and complied with.
References to potential dangers do not replace the work protection regulations which must
be observed.
3.2 Symbols and signal words used in the user manual
The user manual uses the following symbols and signal words to indicate hazards or instruc-
tions. The safety instructions are always placed before an action.
CAUTION
Indicates a potentially hazardous situation.
If it is not prevented, it may result in light or minor injuries and material damage.
ATTENTION
Indicates a potentially hazardous situation.
If it is not prevented, it may cause damage to the device or items in its vicinity.
IMPORTANT
Indicates application hints and other especially useful information without any resulting haz-
ardous or damaging situations.
ENVIRONMENTAL PROTECTION
Indicates application hints and information to aid the proper disposal and handling of the
substances and materials used.

Safety instructions
10 Edition 06/2015 InnuPure C16
3.3 Safety markings on the InnuPure C16
Safety and notice symbols have been attached to the InnuPure C16 whose content must
always be observed.
Damaged or missing safety and notice symbols can cause incorrect actions leading to per-
sonal injury or material damage! The symbol labels must not be removed! Damaged symbol
labels must be replaced without delay!
Figure 1 Safety symbols at the front and rear of the InnuPure C16
Warning sym-
bol Meaning Remark
Warning against a hazard
location Warning against mechanical danger from moving equipment parts
Biological hazard Warning against damage from biological sub-
stances Observe the corresponding protection
instructions!
Reaching inside the de-
vice prohibited during
operation
Warning against crushing by moving parts.
Notice symbol Meaning Remark
Always disconnect the
plug from the power sup-
ply before opening the
device
Before opening the device:
Switch off the device and disconnect the
mains plug from the mains socket and the de-
vice.
Observe the instructions
for use. Read the instructions for use before com- mencing work.
WEEE identification of
electrical and electronic
equipment
The device must be disposed of separately
from household waste as electrical and elec-
tronic waste after its useful life has expired.
2x4 AT, 250V Identification of the inter-
nal fuse Only use the specified fuses!

Safety instructions
InnuPure C16 Edition 06/2015 11
3.4 Technical condition
The InnuPure C16 corresponds in its design and construction with the current state-of-the-art
technology. Unauthorized modifications or changes, especially such that affect the safety of
staff and the environment, are not allowed.
Observe the following notes:
The operator must only operate the device in a sound and operationally safe condi-
tion. The technical condition must always comply with the legal requirements and
regulations.
Prior to every use the device must be checked for damage and sound condition.
Any changes in the device affecting its safety must be reported by the operating
personnel to the operator without delay.
3.5 Requirements for the operating personnel
Observe the following notes:
The InnuPure C16 must only be commissioned, operated and serviced by trained
personnel instructed in technical safety.
The operation or servicing of the device by minors or individuals under the influ-
ence of alcohol, drugs or medication is not permitted.
It must be ensured that only authorized personnel works at the device.
The operating personnel must be familiar with the dangers arising from the sub-
stances used. Appropriate protective equipment must be used.
3.6 Safety instructions, transport and installation
Observe the following notes:
Only transport the device in its original packaging! Ensure that all transport protec-
tions have been fitted and the device is completely empty, cleaned and decontami-
nated.
The InnuPure C16 may only be installed by service personnel from Analytik Jena
AG or by persons authorized by Analytik Jena AG.
To prevent damage to health, the following must be observed when moving the
device in the laboratory (lifting and carrying):
– For reasons of safety, two persons are required to transport the device and
must position themselves on both sides of the equipment.
– Since the device does not have handles, grip the device firmly with both hands
at the lower end, lifting it simultaneously. Make sure the door is closed. Do not
use the door area to hold the device.
– The guide values and statutory limits for lifting and carrying loads without aux-
iliary equipment must be observed and adhered to.

Safety instructions
12 Edition 06/2015 InnuPure C16
3.7 Safety instructions - operation
Observe the following notes:
The operator of the InnuPure C16 must make sure before each commissioning that
the condition of the device including the safety equipment is sound. This applies in
particular after each modification or extension of the device or its repair.
The device may only be operated if all protective equipment (e.g., doors) are in
place, properly installed and fully operational.
Free access to the device switch on the back of the enclosure must always be en-
sured during operation.
During operation and after aborting an extraction protocol, the operator must not
reach with his hands into the device chamber. Otherwise the operator may get
burned at the magnet heating adapter (max. 80°C).
The ventilation equipment on the device must be in good working condition. Cov-
ered vents or ventilation slits etc. may cause the device to break down or may
cause damage to it.
The mains plug must only be plugged into a power outlet with protective ground
connection. The device may only be connected to power sources whose nominal
voltage is the same as that on the nameplate of the equipment. The protective ef-
fect must not be invalidated by the use of an extension line which does not have a
protective conductor.
Do not introduce any objects into the device and prevent fluids from entering the
device through openings or gaps.
Do not short circuit the device and only use fuses in accordance with the specifica-
tions in the technical data.
3.8 Handling hazardous substances
Even when the device is used as intended, the risk of damage to health when handling haz-
ardous substances cannot be excluded. The operator is solely responsible for ensuring
compliance with all safety requirements to protect individuals and property when handling
radioactive, infectious, toxic, caustic, flammable and other hazardous substances.
Control the handling of hazardous substances in accordance with the safety cate-
gory of the lab, the details in the manufacturer safety data sheets and additional
national and international regulations (WHO, "Laboratory Biosafety Manual").
Wear personal protective equipment when working at the device.
Observe all notices on the cleaning and decontamination of the device.

Safety instructions
InnuPure C16 Edition 06/2015 13
3.9 Chemical resistance of the device
Aggressive substances may damage the device. Although the materials used are resistant to
most commonly used substances, material damage from aggressive substances cannot be
excluded.
Before using aggressive substances (e.g., acids, bases or organic solutions),
check whether the materials that are in direct contact with the substances are re-
sistant to them.
Only use substances that are compatible with the materials listed.
If in doubt, contact Analytik Jena AG.
Components Material
Filter tips PP
Piston seal Aluminum, stainless steel, PTFE, rubber (NBR 70).
The pistons are not contaminated with sample if the filter tips
are used.
Reagent cups PP or PTFE
Overview 1 Components and materials in direct contact with the sample
The above-mentioned components are not resistant to the following substances:
Hydrogen fluoride (HF/hydrofluoric
acid)
Highly concentrated acids
Cleaning powder
Paint thinner
Naphtha
Gasoline
Acetone
Cleaning spray
Ozone
Salt-containing detergent
(NaCIO/sodium hypochlorite)
3.10 Behavior during emergencies
If there is no immediate danger of injury, immediately switch the device switch of
the InnuPure C16 to the "0" position during dangerous situations or accidents when
possible and/or disconnect the mains plugs from the mains outlets!
A rapid response can save lives during an emergency, therefore the following has to be en-
sured:
The operating staff must be familiar with the location of safety equipment, accident
and danger alarms as well as first aid and rescue equipment as well as their han-
dling.
The operator is responsible for ensuring the operating staff are properly trained.
All first aid equipment (first-aid kit, eyewash bottles, stretcher, etc.) as well as fire-
fighting equipment (fire extinguishers) must be within reach and always easy to ac-
cess. All equipment has to be in a sound condition and must be checked regularly.

Safety instructions
14 Edition 06/2015 InnuPure C16
3.11 Standards and directives
The device was manufactured according to the currently valid technology regulations and the
approved safety related regulations.
When constructing the device, the relevant safety and health requirements of the applicable
laws, standards and regulations were applied. The safety of the device is confirmed by the
CE mark and the declaration of conformity.
All the information regarding safety corresponds to the currently valid regulations of the Eu-
ropean Union. In other countries, the applicable laws and country specific regulations have
to be complied with.
Besides the safety instructions contained in this user manual and the local safety regulations
that apply to the operation of the device, the general applicable regulations regarding acci-
dent prevention, occupational health and safety and environmental protection have to be
observed and complied with.
References to potential dangers do not replace the work protection regulations which must
be observed.

Technical description
InnuPure C16 Edition 06/2015 15
4 Technical description
4.1 Basic system design
The InnuPure C16 is a flexible and efficient extraction system for the fully automated isola-
tion and purification of nucleic acid. The system, developed and produced in Germany, has
been designed for low sample throughput. A large selection of different source materials can
be used. The system combines a unique fluid handling technology with an extremely fast
walk-away principle.
The InnuPure C16 is equipped with pre-installed extraction protocols to prevent time-
consuming programming. The high degree of flexibility offered by the InnuPure C16 enables
the parallel isolation of DNA and RNA from up to 16 samples. The work-intensive process of
sample lysis which so far mostly had to be performed separately is now part of the automatic
extraction process (dependent on the source material).
The nucleic acids to be isolated adsorb at surface-functionalized magnetic particles. The
necessary extraction chemicals are added manually as necessary and enable the purifica-
tion of ultra-pure nucleic acids with excellent yields.
The extraction principle effectively prevents cross contamination, a problem often occurring
in vacuum-based extraction methods. The isolated nucleic acids can then be used immedi-
ately for further downstream applications.
Different specially optimized extraction kits are available for the InnuPure C16:
isolation of genomic DNA
viral or bacterial nucleic acids
processing of forensic samples
processing of food samples
processing of plant samples
PME-Extraction of cell free fluids
Extraction with bisulfite conversion
Depending on the application, the extractions take between 28 and 128 minutes.
4.2 Design, connections, indications
The InnuPure C16 is a stand-alone device. The operation and device control take place via
the control unit HID-Pro 320 attached to the front. Sample processing follows pre-installed
protocols tailored to the extraction kits. The kits include all reagents necessary for extraction,
permitting extraction to run fully automated. During operation the front door of the InnuPure
C16 is closed. For the status control of the device the touch sensor has been equipped with
an LED strip. This illuminates dependent on the operating state green or red or indicates the
use of the touch sensor by alternating green/red flashing.

Technical description
16 Edition 06/2015 InnuPure C16
1
Control unit HID-Pro 320
2
Front door
3
Sample tray adapter
4
LED status indication
5
Touch sensor
Figure 2 Front view of the InnuPure C16
1
Mains switch
2
Fuse holder
3
Mains connection
4
RS 232 interface
5
Bridging switch of the touch sensor (standby switch)
6
Type plate
Figure 3 Rear connections and switches at the InnuPure C16

Technical description
InnuPure C16 Edition 06/2015 17
1 Tip ejector
2 Cones for accepting tips
3 Guide rails for the sample tray
4 Drip tray
5 Magnet heating elements (only visible when
extended)
Figure 4 Device view with open front door
All pre-manufactured reagent packs necessary for the extraction process (including all buffer
solutions), the filter tips and the elution vessels are placed onto the sample tray. Depending
on the number of samples, reagent plates (deep well plates) with eight sample positions or
reagent strips for individual samples will be used. Thus, within a single extraction protocol,
one sample in a reagent strip up to a maximum of 16 samples in two deep well plates can be
processed. Optionally available adapters are used to accept the reagent strips. Reagent
plates are placed directly into the sample tray. For populating the sample tray, the tray must
be placed into the priming station supplied.
Positions 1 and 3 of the strips and plates are used as an ejection location for used tips later
in the process. To ensure correct operation of the tip ejection, it is absolutely necessary that
these positions are fully opened (at least 7 mm in diameter) with the optional piercing tool or
another suitable tool before starting.
The loaded sample tray is inserted into the adapter in the front door (3 in Figure 2, p. 16) and
then automatically pulled into the correct position in the InnuPure C16.
1
Filter tips
2
Elution vessels for purified
samples
3
Tip block
4
Holding-down clamp
5
Sample block for reagent
plates or adapter for reagent
strips
6
Serrated guide rail
7
Adapter for reagent strips
Figure 5 Sample tray

Technical description
18 Edition 06/2015 InnuPure C16
Figure 6 Priming station and optionally available piercing tool
The InnuPure C16 uses the flexible and portable control unit HID-Pro 320 with the large 5.7‘‘
touchscreen. The integrated computer based on Windows CE enables the use of typical
Windows functions with a clearly structured menu interface. Thus, the entire system be-
comes a stand-alone device. For the review of the running extraction, the status of the cur-
rent step is displayed in real-time. The user can thus follow every routine clearly and contin-
ually. The USB port enables the transfer of new extraction protocols and customized sample
setups as well as the implementation of a simple software update. In addition, the USB port
can also be used to download the logfiles of individual extraction runs.
1
Interface to connect to the InnuPure
2
Network connection
3
USB port
Figure 7 HID-Pro 320