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Analytik Jena 845-00003-03, User Manual

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2015

IX

 

Table of contents

1

General Information  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

1.1

General

 

User

 

Manual

 

Advice

 

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1.2

Target

 

Group

   

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1.3

Conventions

  

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1.3.1

Textual

 

Markups

 

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2

1.3.2

Warning

 

Signs .

 

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3

1.4

Intended

 

Purpose

   

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. 4

1.5

Conforming

 

Use

  

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. 4

1.6

Warranty

 

&

 

Liability

 

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. 6

1.7

Scope

 

of

 

Delivery

   

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. 7

2

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  9

2.1

InnuPure

®

 

C96

  

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. 9

2.2

Summary

 

Table

 

of

 

Operating

 

Data

 

&

 

Conditions

 

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3

Safety Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11

3.1

General

 

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3.2

Standards

 

&

 

Guidelines

 

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3.3

Safety

 

Labeling

 

Provided

 

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System

  

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3.4

Mechanical

 

Danger

 

Zones

 

&

 

Safety

 

Mechanisms

 

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3.5

General

 

Safety

 

Notes

 

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3.6

Requirements

 

for

 

Operating

 

Personnel

   

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. 16

3.7

Safety

 

Requirements

 

for

 

Transportation

 

&

 

Installation

 

16

3.8

Safety

 

Notes

 

for

 

Operation

  

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3.8.1

General

 

Advice

 

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3.8.2

Explosion

 

Proofness,

 

Fire

 

Prevention.

 

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3.8.3

Electrical

 

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3.8.4

Fundamental

 

Maintenance

 

&

 

Care

 

Rules

 

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3.8.5

Handling

 

of

 

Dangerous

 

Substances

 

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18

3.8.6

Chemical

 

Resistance.

 

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3.9

Rules

 

of

 

Conduct

 

in

 

Cases

 

of

 

Emergency

 

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. 20

4

Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21

4.1

Setup

   

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. 21

4.1.1

Basic

 

Unit.

 

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21

Summary of Contents for 845-00003-03

Page 1: ...InnuPure C96 User Manual ...

Page 2: ......

Page 3: ...duplicated photocopied saved to a storage system or transferred to electronic media without prior written permission of the publisher Publisher Analytik Jena AG Konrad Zuse Straße 1 D 07745 Jena Tel 49 36 41 77 70 Fax 49 36 41 77 92 79 Service Analytik Jena AG Konrad Zuse Straße 1 D 07745 Jena Tel 49 36 41 77 9411 Fax 49 36 41 77 767776 Ordering code number OL7022 120 26XBLE01 Document type Transl...

Page 4: ......

Page 5: ...se S D 07745ÅJe sÅdasÅnachst e that the p Å InnuPure C 30 7022 120 Å nÅderÅMasch timmungenÅ 4 108 EGÅüb Å uirements of the EC Direc ting to electr teÅNormen Å aschinenÅ ÅAllg tzeÅ ÅRisikobeu rungÅ mmungenÅfürÅ ÅSteuer ÅRege derungenÅanÅ dÅsemiautoma AnalysenÅundÅa ÅSteuer ÅRege MV Anforderun enstellungÅd mpile the re Herstelle ÅVerkehrÅgebrac berücksichtigt ÅD placedÅonÅtheÅm sÅnoÅmoreÅvalid Å g1 ...

Page 6: ......

Page 7: ...2015 VII ...

Page 8: ...VIII 2015 ...

Page 9: ... Standards Guidelines 11 3 3 Safety Labeling Provided at the System 12 3 4 Mechanical Danger Zones Safety Mechanisms 14 3 5 General Safety Notes 15 3 6 Requirements for Operating Personnel 16 3 7 Safety Requirements for Transportation Installation 16 3 8 Safety Notes for Operation 17 3 8 1 General Advice 17 3 8 2 Explosion Proofness Fire Prevention 17 3 8 3 Electrical 17 3 8 4 Fundamental Maintena...

Page 10: ...rage 33 5 1 Safety Notes 33 5 2 Description 34 5 2 1 Packaging 34 5 2 2 Storage 34 5 3 Transportation Packaging Instructions 35 5 3 1 Installation of Shipping Retainers 35 5 3 2 Packaging 36 6 Routine Start Up Procedure 37 6 1 Site Requirements 37 6 1 1 Installation Requirements 37 6 1 2 Footprint Requirements 37 6 1 3 Energy Supplies 38 6 2 Starting Up 39 6 3 Software Installation 40 7 Operation ...

Page 11: ...ty Notes 53 9 2 Maintenance Work 54 9 2 1 Overview 55 9 3 Maintenance Inspection Instructions 56 9 3 1 Clean System 56 9 3 2 Sealing Plate 57 9 3 3 Checking for Proper Front Door Function 58 10 Shutting Down 59 11 Accessories Spare Parts 61 11 1 Accessories 61 11 1 1 Upgrade Kits 61 11 2 Spare Parts 62 12 Waste Disposal 63 12 1 Consumables 63 12 2 Reagents 63 12 3 System Accessories 63 ...

Page 12: ...XII 2015 ...

Page 13: ...e appropriate measures for fault removal This User Manual must be readily available to operating and maintenance personnel at all times 1 2 Target Group This User Manual addresses Qualified and properly trained expert personnel who are able to operate the system and provide general care Requirements for Operating Personnel on page 16 Employees with responsibility for the planning of process sequen...

Page 14: ...e table below Table 1 Graphic design styles of cross references Type of cross reference Graphic style Explanatory note Reference to an illustration Fig 1 Illustration is on the same page Reference to an illustration and a page Fig 1 on page 17 Illustration is on another page Reference to a position within an illustration Pos 2 Fig 1 Provides reference to a position within a speci fied illustration...

Page 15: ...t in death or serious injury crippling if not avoided CAUTION Dangerous situation Potential consequences light or moderate physical injury NOTICE Dangerous situation Potential consequences material damage NOTE Useful application advice no potential danger involved NOTE Note regarding environmental protection ...

Page 16: ... stan dard SBS format Different tested extraction kits are available for use with the InnuPure C96 for example kit for isolation of genomic DNA kit for isolation of viral or bacterial nucleic acid kit for the processing of forensic samples System operation will be deemed as conforming if solely based on extraction kits that have been approved by the manufacturer and specified for use with the Innu...

Page 17: ...ronmental protection and waste disposal The user is advised to issue special operating instructions where the system is to be operated with the involvement of hazardous substances Accordingly this User Manual contains no safety note warning of personal injury or material damage caused by substances being examined Process control must rely on included software Alterations or damage to system softwa...

Page 18: ... not covered by warranty Any deviation from conforming use as defined in this User Manual operating requirements process sequences will result in restricted acceptance of warranty or liability claims in the event of damage In the event of personal injury or material damage no claim for warranty and liability will be accepted unless the system is operated as specified in section Conforming Use on p...

Page 19: ... configurations as listed below InnuPure C961 Transporting unit Stacker A Stacker B Cabling Line power cable USB cable Documentation User Manual Translation of original User Manual EC Conformity Declaration Accessories catalog Packaging Shipping case Shipping brackets fixtures 1 Basic unit with pipetting head 96 1000 μl ...

Page 20: ...8 2015 General Information ...

Page 21: ...mm Weight approx 50 kg Micro plate formats 96 Deep Well Micro plate SBS Standard Pipetting head Number of channels 96 Motion travel length Z direction motorized approx 85 mm Volume range 10 μl 1000 μl Tip types 1000 μl Deep Well DW Precision CV 25 μl 100 μl 2 100 μl 1000 μl 1 Stack Number Designation 2 Stack A and B Usable height approx 550 mm Transporting unit micro plate Function positions 4 pie...

Page 22: ...e fuses 5x20 mm T 6 3 A Power consumption operation 300 VA Interfacing points USB Airborne sound emission 70 db A Operating storage conditions Operation Permissible ambient temperature Permissible relative air humidity 15 C to 35 C 85 at 30 C no formation of condensate Storage transportation Permissible ambient temperature Permissible relative air humidity 10 C to 50 C 75 at 30 C no formation of c...

Page 23: ...d its components have been designed in accordance with basic safety and health requirements under applicable laws standards and guideline regulations CE labelling and a declaration of conformity are included to document the safety of the system and its components All specifications relating to safety reference the European Union regulations in their latest binding revisions Other specific national...

Page 24: ...nt such danger NOTE Affixed warning notes and safety symbols are an integral part of the system and its components and must be followed under any circumstances Check warning labels and safety symbols for intactness and completeness before you begin any kind of start up action Do not proceed to start up action if you have identified a missing or damaged warning note or safety symbol Safety symbol M...

Page 25: ...the system Warning note Meaning Comment Warns of dangerous electrical voltage Refrain from system shielding or cover part removal at all times Allow repair to be carried out only by qualified experts Replace defective fusing with a fuse of specified type in all cases ...

Page 26: ...rection shift motion Motion range of lifters motorized motion in Y direction Motion range of transporting unit motorized motion in X direction Follow these general rules Do not place your hands or fingers including objects you are holding into a mechanical motion path at any time during system operation Faulty action or mis operation may cause material damage or physical injury Always use software...

Page 27: ...e or with safety and protection devices installed in a nonconforming manner Operate the system only at a line voltage that complies with nameplate specifications Observe prescribed maintenance intervals Maintenance Care on page 53 Use only accessory items consumable materials and spare parts specified in this User Manual or provided or recommended by Analytik Jena AG Service and repair work and pr...

Page 28: ...l protective equipment should be applied if necessary Before a break in operation or on completion of work adequate measures should be taken for skin cleaning and skin protection 3 7 Safety Requirements for Transportation Installation You are prohibited from any kind of unauthorized mounting or installation work Faulty installation may create considerable danger Follow these general safety rules T...

Page 29: ...nces Operating personnel must be duly informed about the locations and the proper handling of fire extinguishing equipment in the operating room 3 8 3 Electrical Work on electrical and electronic parts of the system and its components may only be carried out by a suitably qualified electrician and in accordance with latest binding electrical regulations Refrain from start up action of any kind if ...

Page 30: ...AG Accessories Spare Parts on page 61 3 8 5 Handling of Dangerous Substances The system owner will be solely responsible for compliance with all safety requirements in place for the protection of persons and material goods during work involving radioactive infectious toxic etching combustible and other dangerous substances The system owner operator is advised to establish a special operating pract...

Page 31: ...e damage to shielding parts or the control panel Component Material Pipette tips PP Piston seals1 1 Aerosols are likely to establish indirect contact between substances and piston seals The pistons are made of stainless steel the piston seals of polyethylene high density PE HD Reagent vessels PP Substances1 1 This table is not exhaustive Hydrofluoric acid HF Highly concentrated acids Cleaning powd...

Page 32: ...nnel must be aware of the locations and the proper handling of safety devices accident and hazard alarms as well as first aid kits and emergency rescue equipment The system owner operator will be responsible for providing adequate training for operating personnel All first aid items medical chest eyewash bottles stretchers etc and fire fighting equipment fire extinguishers must be kept within easy...

Page 33: ...nsor with LED Touch Sensor with LED on page 27 2 Pipetting head 96 1000 μl Pipetting Head 96 1000 μl on page 25 3 Stacker B shaft Stackers on page 26 4 Stacker A shaft Stackers on page 26 5 Two place carriage 6 Heating magnet module Heating Magnet Module on page 28 7 Rotatable legs five for vertical adjustment 1 2 3 4 5 6 7 ...

Page 34: ...chnical Description 4 1 2 Nameplate Fig 4 Nameplate Nameplate specifications Manufacturer details Product designation details type designation tradename Identification code model serial number Year of manufacture ...

Page 35: ...2015 23 Technical Description 4 1 3 Directions Coordinates of Motion Fig 5 Directions and coordinates of motion Z Y X ...

Page 36: ...plate format according to the SBS standard The system s compactness makes it possible to pipette process liquids in a volume range of 10 μl 1000 μl per pipette tip Its working area is completely enclosed An integrated linear transporting unit carriage with two placement positions moves a given microplate in X direction from a given stacker shaft to the pipetting head and back again Located below t...

Page 37: ... within these air spaces They are powered by a common drive Piston motion occurs in steps of 0 1 μm thus achieving an accuracy resolution that corresponds to a fraction of a microliter Further main factors of influence on accuracy resolution performance are the wettability of tips dimensional accuracy of outlet openings way in which the system and liquid are handled NOTE Piston motion creates nega...

Page 38: ...hey retreat so a microplate can be retrieved from the given shaft to be placed down on the carriage This stack procedure is monitored by a sensor installed in the each stack shaft and runs in a fully automated process Single microplates or a whole stack of microplates can be loaded into a stacker Care should be taken to ensure that only such types of microplates are loaded which are actually inclu...

Page 39: ...ge from red to green light as you do this Power on condition will be reported by a green lighting LED During sleep mode the InnuPure C96 is not switched off completely but consumes power To switch off the InnuPure C96 completely switch off the device from the mains switch at the equipment backplate Switching off the touch sensor The touch sensor can be bypassed Then the device can no longer be swi...

Page 40: ... is necessary to prevent breaks in operation resulting from accidental triggering of the sensor CAUTION Dangerous situation Burn injury Hot surface while process is running Beware of physical contact Refrain from placing your hands or fingers into the inner system space immediately following a break in a running extraction protocol sequence The heating magnet module may have a temperature as high ...

Page 41: ...ical Description 4 3 6 Connection Points Fig 11 Connection terminals at the InnuPure C96 1 100 240 V 50 60 Hz power line inlet with power switch and power inlet fuse 2 Sliding switch stand by 3 USB 2 0 type B 1 3 2 ...

Page 42: ...ontinuous mixing throughout this working step will help the lysis process Lysis external For external lysis a sample plate is equally placed onto the left carriage position The automatic protocol routine begins with the workstep of binding 2 Binding The procedure of binding nucleic acids to the magnetic particles begins with the addition of binding buffer Once the binding buffer has been transferr...

Page 43: ... over effects of residue poten tially accumulating in the tips the tips are subjected to rinsing in between certain washing steps 7 Ethanol removal To remove residue of ethanol inside the wells a drying workstep follows This workstep consists in the heating plate of the heating magnet module being turned on and pressed against the bottom of the plate 8 Elution Elution buffer is supplied This is fo...

Page 44: ...32 2015 Technical Description ...

Page 45: ...nfluences mechanical shocks or formation of condensed water may destroy individual system components Adequate precautions should be taken to protect all components from environmental impacts mechanical shock or formation of condensed water during transportation or shipment Temporary open air storage of the system is forbidden NOTICE Improper packaging is likely to cause damage to the system NOTE U...

Page 46: ...from force impacts or improper performance of loading or unloading work Prevent formation of condensed water due to significant variations in temperature mechanical shock or vibration 5 2 2 Storage If the InnuPure C96 is not installed immediately after arrival of product shipment or not required for a longer period of time it should preferentially be stored in its original packing case Climatic re...

Page 47: ...ig 12 Overview 1 Two place carriage 2 Pipetting head 3 Stacker B 4 Stacker A Placement of shipping brackets retainers Prescribed shipping fixtures are duly installed 1 Check that pipetting head is actually secured 2 Check that all mechanically moving parts are properly secured with cable ties plastic foam pads or adhesive tape 1 2 3 4 ...

Page 48: ...m is in completely packed condition Phys dimensions approx 1000 x 740 x 800 mm 1 Place system onto the bottom of the shipping case as shown on the right so its back panel is located against the back end padding bar 2 Put on upper shaped piece 3 Safely store accessory items provide adequate padding for free spaces 4 Close shipping case and affix warning stickers and shock indicators ...

Page 49: ...e system directly at doors or windows nor close to sources of electromagnetic interference Prevent direct exposure to sunlight and radiation emitted by heaters Provide air conditioning for the room if necessary Provide easy access to all system parts at all times and do not obstruct ventilation slots by placing other equipment or fixtures on such inlet outlet positions Allow enough time for the sy...

Page 50: ...tective conductor wiring there is life threaten ding danger due to electrical shock Insert the main power plug only into a mains socket with a grounded PE contact Make sure that the protection effect is not rendered ineffective by extension cables without a PE conductor or by the use of a voltage regulating transformer CAUTION Operation at a mains voltage level or frequency other than specified on...

Page 51: ... power on state a Let the system run in idle mode for 1 hour or more with power on The system is ready for operation CAUTION There is danger of physical injury material damage Attention should be paid to the system s weight Carefully hold the system for retrieval from the packing case NOTE Store original packing for cases of necessary service NOTE The system must undergo acclimatization in order t...

Page 52: ...icking on WkRuntime exe Follow the instructions of WibuKey Setup 3 Installation of control software InnuPure C96 Application Studio Choose setup exe on the CD to install control software InnuPure C 96 Application Studio Follow further prompts of the installation program 4 Start Communication between PC and device Set COM Port After installing software check communication between PC and device firs...

Page 53: ... does not initialize close InnuPure C96 Application Studio and choose the next COM Port in the InnuPure C96 COM Port Configuration Try initializing process again Repeat this procedure until the device initilizes After initilizing the system software settings are finished Software requirements Windows XP SP3 Windows Vista Windows 7 Professional Enterprise or Ultimate Internet Explorer 6 0 7 0 or 8 ...

Page 54: ...42 2015 Routine Start Up Procedure ...

Page 55: ...On Off switch into position I Fig 13 Fig 13 On Off switch 4 Follow instructions and advice regarding stand by mode Touch Sensor with LED on page 27 5 Watch operating state indicator LED Green steady Reports completion of init routine and readiness for operation 6 Turn PC on and trigger starting routine The system is ready for action and to carry out commands of the computer controller ...

Page 56: ...n e g version number 5 Display of currently running protocol step with pictograms or pictures to illustrate the flow progress of a protocol 6 Operator prompts with active operation control elements 7 Start button for triggering extraction protocols filling routines or system functions 8 Stop button for haulting or terminating extraction protocols filling routines or system functions 9 Description ...

Page 57: ...lays pictures to illustrate required user action for operation control This preferentially concerns action for replacement of a tip magazine or for placement of plates and reservoirs Related instructions and prompts are displayed in screen area 6 Some active control elements take the user step by step through the entire processing sequence of a selected protocol or filling routine To trigger a pro...

Page 58: ... into collecting position Leak test To clean the silicone membrane and to check that the pipetting head is free from points of leakage First the protocol releases tips Remove tips and use a dustfree slightly moistened piece of cloth to clean the silicone membrane After 1 minute drying the silicone membrane a reservoir with 100 ml dye solution needs to be placed onto left car riage position Inserti...

Page 59: ...otocols Use the list of available protocols to select the extraction protocol that you find referenced in your kit manual Then press Start button 7 7 3 Turning Off To turn the system off proceed as follows 1 Wait for system to finish all currently running work routines 2 Take pipette tips off and install shipping retainer 3 Use On Off switch on the lateral side to turn the system off The operating...

Page 60: ...48 2015 Operation ...

Page 61: ...uct This may render potential claims for warranty null and void WARNING Danger as a result of electric voltage Observe all safety rules when you inspect cabling for possible faults Error Error code Cause Action for removal Product does not work although connected to line socket power Mains plug was inserted into the power socket or the product s combi seal in a non conforming manner Inspect line p...

Page 62: ...cket before you replace a fuse Check for absense of voltage in the pipettor Description Type Rated specs Line power fuse T 6 3 A 250V AC 5x20 mm 1 Turn power supply off 2 Detach line power cord from system inlet port and mains socket 3 Use a small screwdriver to extract the fuse holder from the combi seal Fig 16 4 Perform check to identify the defective fuse 5 Remove defective fuse from fuse holde...

Page 63: ...tion At first you should make sure that restoration to operating condition will imply no danger and carry out the following steps in this same order Turn power off Turn it on again after a short while Restore PC to operating condition if necessary and trigger empty method This sequence of actions is merely intended as a recommendation The correct sequence of actions is always conditional on the pa...

Page 64: ...52 2015 What to do if ...

Page 65: ...parts Maintenance repair or adjustment of system modules under electrical voltage may only be carried out by a qualified electrician CAUTION Penetrating liquid may cause material damage to electrical and electronic components Make sure that no liquid can penetrate into the inner space during any kind of maintenance or care NOTE Intervention to mechanical or electronic parts in the inner space may ...

Page 66: ... hence an increased probability of failure Check for signs of wear and tear on assemblies under mechanical strain and initiate necessary replacements promptly on identifying a case of wear and tear All systems parts capable of manual or motorized move are subject to natural wear Similarly electronic components have no unlimited lifetime NOTE Dirt e g dried on liquid may increase wear dramatically ...

Page 67: ...y Half yearly Clean System on page 56 x Replace used tips as neces sary or at least once in a week Clean all liquid holding vessels with disinfectant as neces sary Sealing Plate on page 57 x Checking for Proper Front Door Function on page 58 x Check electrical components and cabling test PE conductor only qualified electrician x ...

Page 68: ...em undergoes re initialization and becomes operational again NOTICE Never use cleaning powder paint thinner or solvents like ethanol gasoline acetone or isopropanol to clean the pipettor Substances of this type will attack the surface of enclosure panels for more details refer to Chemical Resistance on page 18 Use a soft piece of cloth slightly moistened with mild soap or disinfectant solution to ...

Page 69: ...stened cloth for cleaning Alternatively specific microplate adhesive tape nunc 236269 can be carefully affixed to and removed from the sealing plate again 4 Use particular care when cleaning in order to prevent accidental shifting of the sealing plate Otherwise there is danger of plate openings getting clogged with fluff balls 5 Do not tighten the tip magazine before the sealing plate has fully dr...

Page 70: ...roper Front Door Function To ensure safe system operation you should perform functionality checks as follows 1 Turn system power on 2 Actuate front door and check front doors for ease of movement general motion stop when any of the doors is opened ...

Page 71: ...urpose 5 Disconnect line power cable from socket bar or line power socket 6 Remove all microplates reservoirs and accessories 7 Clean and disinfect the pipettor and its components as described in handling instructions for the most recently used materials and substances 8 Protect the system from sedimentation of dust The system has been completely shut down CAUTION There is danger of physical injur...

Page 72: ...60 2015 Shutting Down ...

Page 73: ...commended by the manufacturer The manufacturer will refuse any warranty in the event of damage or function failure as a result of system operation with unspecified accessory items Accessories Ordering code number Comment Tip Transfer Tool 844 00191 3 1000 μl 8 Channel Magazine1 1 The time of printing in preparation 844 00189 3 1000 μl Tip Magazine 844 00190 3 1000 μl TipRack 844 70194 0 96 Tips Ra...

Page 74: ...62 2015 Accessories Spare Parts 11 2 Spare Parts Table 9 Spare parts Spare part Ordering code number Comment Electric fuse Replacement of Inlet Fuse s on page 71 ...

Page 75: ...rate into a sewage system or the soil The appropriate rules and practices must be closely followed for disposal of such substances NOTE Unless otherwise agreed the pipettor system including any of its components must be disposed in accordance with currently binding regulations of law on termination of use Action for disposal will be the responsibility of the system owner The procedures to be follo...

Page 76: ...64 2015 Waste Disposal ...

Page 77: ...nol 56 L Liability 6 Lysis 30 M Maintenance 18 Maintenance work 54 O Operation 43 P Packaging 36 Paint thinner 56 Piston seals 19 Protection Devices 14 Protocol routine 28 Protocol sequence 30 R Reagents 63 Red LED 27 Residue of ethanol 31 Restoring 51 S Safety Labeling 12 Safety notes 15 Safety symbol 12 Scope of delivery 7 Serial number III Setup exe 40 Site requirements 37 Sliding switch 27 Spa...

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