R
Installation Manual
Version 3.0
29-Sep-2009
04906900001 INSTALLATION-MANUAL cobas c 111 |
Last printed: 7 January 2010 |
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cobas c 111 Installation Manual
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04906900001 INSTALLATION-MANUAL cobas c 111 |
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cobas c 111 Installation Manual
CONTENT: |
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1. |
Preface ...................................................................................................................... |
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4 |
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1.1 |
Revision history ............................................................................................... |
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1.2 |
Copyrights and trademarks............................................................................. |
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1.3 |
Manufacturer ................................................................................................... |
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1.4 |
Intended use..................................................................................................... |
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2. |
About this manual................................................................................................... |
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2.1 |
Conventions used in this manual ................................................................... |
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2.1.1 |
Symbol listing .............................................................................................. |
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2.1.2 |
Abbreviations............................................................................................... |
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Units ..................................................................................................................... |
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Acronyms ............................................................................................................. |
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3. |
Safety information................................................................................................... |
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3.1 |
Safety classifications......................................................................................... |
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3.2 |
Safety notices.................................................................................................... |
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4. |
Overview................................................................................................................. |
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4.1 |
Introduction................................................................................................... |
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4.2 |
Instrument internal layout............................................................................ |
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4.3 |
Technical specifications................................................................................. |
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5. |
Delivery, unpacking and set-up of the analyzer.................................................. |
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5.1 |
Delivery .......................................................................................................... |
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5.1.1 |
Packing list ................................................................................................. |
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5.2 |
Additional items required ............................................................................. |
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5.3 |
Unpacking...................................................................................................... |
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5.3.1 Unpacking procedure for instrument with ISE: ...................................... |
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5.3.2 Unpacking procedure for instrument without ISE: ................................ |
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5.4 |
Location of switches and connectors............................................................ |
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Main switch........................................................................................................ |
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Power cable ........................................................................................................ |
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Location of fuses ................................................................................................ |
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Fluid Connections:............................................................................................. |
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USB connection ................................................................................................. |
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RS232 Serial connectors .................................................................................... |
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6. |
Start-up of the Instrument.................................................................................... |
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6.1 |
Instrument with ISE unit .............................................................................. |
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6.1.1 Instrument placement & preparation: ..................................................... |
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6.1.2 Starting the instrument & setup of ISE |
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6.2 |
Instrument without ISE unit......................................................................... |
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6.2.1 Instrument placement & preparation: ..................................................... |
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6.2.2 |
Starting the instrument ............................................................................. |
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6.3 |
Single ISE unit................................................................................................ |
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6.3.1 Attaching the ISE unit to the base instrument (if applicable) ................ |
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7. |
Running the analyzer and everyday tasks............................................................ |
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8. |
Shutting down........................................................................................................ |
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9. |
Preparing for transportation ................................................................................ |
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9.1 |
Drain the instrument with ISE of water and cleaner................................... |
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9.2 |
Drain the instrument without ISE of water and cleaner. ............................ |
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9.3 |
Packing procedure for instrument with ISE:................................................ |
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9.4 |
Packing procedure for instrument without ISE:.......................................... |
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10. |
Disposal of the instrument ................................................................................... |
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10.1 |
Disposal of external components.................................................................. |
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11. |
Installation Report Form ...................................................................................... |
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42 |
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12. |
Installation Report cobas c 111 ............................................................................ |
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43 |
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04906900001 INSTALLATION-MANUAL cobas c 111 |
Version 3.0 |
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cobas c 111 Installation Manual
1. |
Preface |
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1.1 |
Revision history |
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Version |
Revision date |
Comments |
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0.1 |
May 2005 |
Draft version |
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0.2 |
June 2005 |
Improved draft |
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0.5 |
January 2006 |
Improved draft 2 |
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0.9 |
May 2006 |
Improved draft 3 |
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1.0 |
June 2006 |
First release version |
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1.1 |
July 2006 |
Corrected version (procedure) |
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1.2 |
August 2006 |
Regulatory corrections |
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1.3 |
March 2007 |
Update of procedures |
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1.4 |
October 2007 |
Update of procedures |
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2.0 |
April 2008 |
Update of procedure for deinstallation ISE |
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2.1 |
Sep 2008 |
Update of instrument placement & prep. |
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2.2 |
April 2009 |
New transport protection |
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Installation procedure ISE adjusted |
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3.0 |
September |
Generally remarks concerning Data base |
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2009 |
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and applications added (empty Database) |
Document Part Number |
04906900001 |
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Published by Roche Diagnostics, a division of F. Hoffmann-La Roche; 4070 Basel, Switzerland.
Questions or comments regarding the contents of this Manual can be directed to the address below or to your Roche representative.
Roche Diagnostics Ltd.
Global Systems Support
Forrenstrasse
CH6343 Rotkreuz
Switzerland
Every effort has been made to ensure that all the information contained in the cobas c 111 Installation Manual is correct at the time of printing.
However, Roche Diagnostic Ltd. reserves the right to make any changes necessary without notice as part of ongoing product development.
1.2 Copyrights and trademarks
cobas c 111, and the R® logo are registered trademarks of F. HoffmannLa Roche Ltd.
Canada:
The above trademarks are owned by Roche Diagnostic Systems, a division of HoffmannLaRoche Limited/Limitee; used under License.
Other countries:
The above trademarks are either owned by or used under license by the Roche affiliate distributing this product.
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cobas c 111 Installation Manual
The following trademarks are acknowledged:
Adobe Acrobat, Linux, Microsoft Windows.
©2008, F. HoffmannLa Roche Ltd. All rights reserved.
1.3 Manufacturer
Manufacturer
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
1.4 Intended use
The cobas c 111 instrument is a continuous random-access analyzer intended for the invitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood. (Only HbA1c application)
It is important that the operators read this manual thoroughly before using the system. Any disregard of the instructions in this or the Operator’s Manual may result in a safety risk.
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cobas c 111 Installation Manual
2. About this manual
This manual is to be used for unpacking, installing and registering the cobas c 111. For detailed instrument information, see the cobas c 111 Operator’s Manual.
2.1 Conventions used in this manual
The conventions used in this manual are as follows:
1., 2., 3., represents sequential steps in a procedure. You should follow these steps in order.
2.1.1 Symbol listing
Caution: Refer to accompanying documents.
Manufacturer of device
These symbols are provided on the type plate of the instrument
Electrical and electronic equipment marked with this symbol are covered by the European directive WEEE. The symbol denotes that the equipment must not be disposed of in the municipal waste system.
(WEEE = Directive 2002/96/EC of the European Parliament and the council of 27 January 2003 on waste electrical and electronic equipment.)
2.1.2 Abbreviations
The following abbreviations are used:
Units
cm |
Centimeters |
in |
Inches |
Ib |
Pounds (weight) |
psi |
Pounds per square inch |
VA |
VoltAmperes |
VAC |
Volts (alternating current) |
M |
Megohm (106 ohms) |
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cobas c 111 Installation Manual
Acronyms
UL |
Underwriters Laboratories Inc. |
IEC |
International Electro technical Commission |
CSA |
Canadian Standard Association |
LED |
Light emitting diode |
CB |
Certification body |
FCC |
Federal Communications Commission |
EN |
European Norm |
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3. Safety information
Before operating the cobas c 111, it is essential that you read and understand the safety information listed here.
3.1 Safety classifications
The safety precautions and important user notes are classified according to ANSI Z535 resp. ISO 3864 standards. You must familiarize yourself with following signs and their meanings:
Danger
Warning
Caution
Indicates a direct danger that, if not avoided, may result in death or serious injury.
Indicates a possibly hazardous situation that, if not avoided, may result in death or serious injury.
Indicates a possibly hazardous situation that, if not avoided, may result in slight or minor injury or may result in damage to
equipment.
General warning symbol on the analyzer
The triangular warning symbol on the analyzer is a general reminder that users should read the safety information contained in this manual. Users must be able to identify specific hazards and take appropriate action to avoid them.
3.2Safety notices
Read the Roche Diagnostics safety notices carefully and make sure you understand them. This information should be made available to new employees and kept for future reference.
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cobas c 111 Installation Manual
Electrical safety
Danger
Biological safety
Danger of electric shock. Keep the side panels closed while the analyzer is connected to the main power supply!
The cobas c 111 is designed in accordance with safety standard EN/IEC 61010-1. Grounding of the instrument and those surfaces
the user can come into contact with is provided by a grounded cable in accordance with protection class 1 (IEC). Users should not perform any servicing except as specifically stated in the cobas c 111 Operator’s Manual.
Liquid waste and cuvette waste are potentially biological hazardous. Always wear gloves when handling those materials. Do not touch parts of the analyzer other than those specified. If sample is spilled on the analyzer, wipe up immediately and apply disinfectant. Consult your laboratory protocol for handling biohazard materials.
Software virus warning
Roche does not provide any anti-virus Software. Therefore, it is essential to take precautions to ensure that any software loaded
onto the system is virus-free.
Do not load any software that is not approved by Roche Warning Diagnostics!
Recommendations
Check any data carrier (e.g. USB memory stick) with an anti-virus program (on another computer) to ensure that they are virus free before using them on the cobas c 111.
Optical Safety
Loss of sight! The intense light of the LEDs may severely damage your eyes. Do not stare into the LEDs! Scanning equipment using LED technology is covered by the international standard IEC 60825-1 LED safety: Class 1
Warning
Instrument Service & Maintenance
The cobas c 111 is an electromechanical device that has no internal electrical parts serviceable by the user. For preventive maintenance, contact your Roche Service representative who is trained and qualified to perform the necessary maintenance.
Any unauthorized modification to the system shall render the warranty or service agreement null and void.
User safety
Read the following list to familiarize yourself with the potential hazards and the precautions for operating the cobas c 111.
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cobas c 111 Installation Manual
Electrical safety
Danger of electric shock if you touch any power supply parts.
Do not access any electrical parts while the analyzer is connected to the main power supply.
Users may replace fuses if they follow the procedures described in this manual. Any other electrical modification is not allowed and may render any warranties on the cobas c 111 null and void.
Fire risk
Danger of explosion through sparks. Keep all potentially flammable or explosive material (for example, anesthetic gas) away from the analyzer.
Spraying liquid on the power supply parts can cause a short circuit and result in a fire. Keep the cover closed while the analyzer is connected to the main power supply and do not use sprays in the vicinity of the cobas c 111.
During fire-fighting operations disconnect the cobas c 111 from the main power supply.
Analyzer in use
Danger of hands injury by moving parts. Keep all covers closed during initialization or operation.
Samples
Danger from infectious sample material can cause severe illness. Avoid direct contact with sample material. Clean contaminated surfaces immediately and dispose of waste according to local regulations. Please refer to your local safety regulations regarding handling sample material.
Waste
Danger from infectious waste material can cause severe illness. Avoid direct contact with waste. Dispose of the waste according to local regulations.
Quality control
Danger of false results. Patients can be put at risk if false results lead to incorrect diagnosis and therapy. Carry out quality controls according to the local regulations.
Correct use
Use the cobas c 111 only for measuring liquid sample material with the specified Roche reagents. Sample material can be serum, plasma, urine.
User qualification
Danger from incorrect operation. The cobas c 111 should only be used by a qualified operator experienced in the use of such equipment.
Environmental conditions
Incorrect location can cause incorrect results and damage to the equipment parts. Follow the installation instructions carefully. Moving the cobas c 111 must be performed only by qualified personnel.
Location
The cobas c 111 is designed for indoor use and the instrument must be located on a stable and level surface that is not subject to vibration. The instrument should not be placed in a position where strong or variable light conditions exist (e.g. direct sunlight). Avoid locations where other equipment may create interference from high frequency or high voltage electromagnetic fields.
Allow sufficient space around the instrument for convenient working.
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Environmental conditions
The cobas c 111 is designed to operate in a controlled environment. In particular the room temperature, relative humidity and atmospheric pollution conditions must be maintained within the limits specified above (par. 4.3). Operation outside of the specified ranges may cause erratic operation or, in exceptional circumstances, component failure.
Protective grounding
The protective grounding is done via the mains power cord. There are no special provisions for protective grounding required.
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Any break in the electrical ground wire, whether inside or outside the ana- |
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lyzer, or disconnection of the electrical ground connection, may create a |
Warning |
hazardous condition. |
Under no circumstances should the user attempt to modify or deliberately override the safety features of this system.
Risk of infection from contaminated samples!
Fluid and cuvette waste is potentially biologically hazardous.
Samples containing material of human origin must be treated as potentially infectious. Always wear protective gloves when handling this material.
Do not touch parts of the analyzer other than those specified.
The whole inside of the system may be contaminated with potentially infectious or toxic material.
Always wear protective gloves when cleaning the following parts: Waste area, Sample Area, Pipetting System e.g., probes,
Battery may explode if mistreated!
Do not recharge, disassemble or dispose of the battery in fire.
Servicing of the battery circuit and replacement of the lithium battery must not be done by the user.
Only authorized persons are allowed to replace the lithium battery. Replace Battery with type Sonnenschein SL-360/S only.
Use of another battery may present a risk of fire or explosion.
User maintenance actions and internal cleaning
All internal cleaning must be performed according to the instructions given in the cobas c 111 Operator’s Manual.
Danger of damaging the Touch-Screen Display
Excessive use of liquid cleaner may damage the Touch-Screen display! Do not spray any cleaner liquid directly onto the screen! Please clean the surface of the monitor with a cloth that is moistened with cleaner liquid.
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cobas c 111 Installation Manual
4. Overview
4.1 Introduction
The cobas c 111 analyzer is intended for in vitro quantitative or qualitative determination of a wide range of analytes in serum, plasma and urine. (Whole blood only with HbA1c application.)
The cobas c 111 is intended for professional use only.
The primary functions of the cobas c 111 analyzer include:
∙Manual loading of various primary and secondary sample tubes onto the instrument providing 8 positions.
∙Sample volume per test from 2 ... 15 µl
∙Manual and/or computer-interfaced test ordering
∙Cooled storage area for Roche reagents. 27 reagent bottles per reagent disk and up to 8 reagent disks can be handled. Using reagents manufactured by Roche Diagnostics ensures best quality of stable and reliable results.
∙Bar-coded reagent bottles for easy handling.
∙Absorbance Photometry measurements with 12 wavelengths ranging from 340 nm up to 659 nm
∙Ion Selective Electrode (ISE) measurements for Na, K, and Cl, using the indirect method. Dilution of the sample 1:6.
∙Result memory can keep up to 300 patient results.
∙Optional formats for data interchange via RS-232 (ASTM-protocol)
∙Sample identification with handheld barcode scanner
∙Internal thermal printer (112 mm paper width)
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4.2 Instrument internal layout
The major components of the analyzer are shown below in fig 1.
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4.3 Technical specifications
Software and data |
Operating System |
LINUX |
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handling |
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VX Works |
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Memory DMModule |
32 MB Flash ROM |
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PXA 255 |
32 MB DRAM |
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Memory RT-CPU |
32 MB Flash ROM |
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PXA 255 |
32 MB DRAM |
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2 MB SRAM |
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Communication between |
10/100 BaseT Ethernet |
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DM and RT |
(for internal use only) |
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Communication between |
TegiLink Bus (RS485) |
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RT-CPU and µC boards |
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Mass Storage |
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internal |
Flash ROM |
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external (data share) |
USB Memory Stick |
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Interfaces (external) |
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2 x USB 1.1/2.0 |
Memory stick, Modem |
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2 x RS-232 |
- Host |
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- Barcode Reader |
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Display |
5.7 in. color LCD, (¼ VGA - |
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320 x 240 pixels); passive |
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matrix touch screen. |
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Printer |
Internal thermal printer (112 |
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mm paper width) |
Samples |
Sample handling |
Direct tube placement |
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manually by user |
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Incubation time |
Max. 12 min. / 40 cycles |
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Typical time to result |
ABS: 4 min. to 12 min. |
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ISE: 90 sec. (Na, K, Cl) |
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Instrument cycle time |
18 sec. |
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Reagent bottles |
Content |
20 ml maximum |
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Identification |
Barcode 2-d, |
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Format PDF417 |
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Number of tests |
50-200 depending of test |
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Calibration |
Use of Roche test-specific |
CFAS, ISE Calibrator, etc. |
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calibrator fluids |
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Use of recommended QC |
PreciNorm, PreciPath, etc. |
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material |
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Cuvette handling |
6 segments of 10 cuvettes |
Manual handling of cuvette |
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each. Single use only |
segments during standby. |
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Incubation Temperature |
37°C ± 0.2°C |
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Measuring Unit |
Absorbance photometer |
20 W halogen lamp |
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12 Wavelengths |
340 nm ... 659 nm |
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Sensor |
Photosensitive diode array |
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Version 3.0 |
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