Roche Cobas C111 Installation manual
R
Installation Manual
Version 3.0
29-Sep-2009
04906900001
INSTALLATION-MANUAL cobas c 111
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cobas c 111 Installation Manual
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CONTENT:
1. Preface ......................................................................................................................4
1.1 Revision history ...............................................................................................4
1.2 Copyrights and trademarks.............................................................................4
1.3 Manufacturer ...................................................................................................5
1.4 Intended use.....................................................................................................5
2. About this manual ...................................................................................................6
2.1 Conventions used in this manual ...................................................................6
2.1.1 Symbol listing ..............................................................................................6
2.1.2 Abbreviations...............................................................................................6
Units .....................................................................................................................6
Acronyms .............................................................................................................7
3. Safety information...................................................................................................7
3.1 Safety classifications.........................................................................................7
3.2 Safety notices....................................................................................................7
4. Overview.................................................................................................................11
4.1 Introduction...................................................................................................11
4.2 Instrument internal layout............................................................................12
4.3 Technical specifications.................................................................................13
5. Delivery, unpacking and set-up of the analyzer..................................................16
5.1 Delivery ..........................................................................................................16
5.1.1 Packing list .................................................................................................16
5.2 Additional items required .............................................................................16
5.3 Unpacking......................................................................................................17
5.3.1 Unpacking procedure for instrument with ISE: ......................................17
5.3.2 Unpacking procedure for instrument without ISE: ................................19
5.4 Location of switches and connectors............................................................21
Main switch........................................................................................................21
Power cable ........................................................................................................21
Location of fuses ................................................................................................21
Fluid Connections:.............................................................................................21
USB connection .................................................................................................21
RS232 Serial connectors ....................................................................................22
6. Start-up of the Instrument....................................................................................23
6.1 Instrument with ISE unit ..............................................................................23
6.1.1 Instrument placement & preparation: .....................................................23
6.1.2 Starting the instrument & setup of ISE ....................................................23
6.2 Instrument without ISE unit.........................................................................26
6.2.1 Instrument placement & preparation: .....................................................26
6.2.2 Starting the instrument .............................................................................27
6.3 Single ISE unit................................................................................................29
6.3.1 Attaching the ISE unit to the base instrument (if applicable) ................29
7. Running the analyzer and everyday tasks............................................................34
8. Shutting down........................................................................................................34
9. Preparing for transportation ................................................................................34
9.1 Drain the instrument with ISE of water and cleaner. ..................................34
9.2 Drain the instrument without ISE of water and cleaner. ............................34
9.3 Packing procedure for instrument with ISE:................................................35
9.4 Packing procedure for instrument without ISE:..........................................39
10. Disposal of the instrument ...................................................................................42
10.1 Disposal of external components..................................................................42
11. Installation Report Form ......................................................................................42
12. Installation Report cobas c 111 ............................................................................43
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1. Preface
1.1 Revision history
Version Revision date Comments
0.1 May 2005 Draft version
0.2 June 2005 Improved draft
0.5 January 2006 Improved draft 2
0.9 May 2006 Improved draft 3
1.0 June 2006 First release version
1.1 July 2006 Corrected version (procedure)
1.2 August 2006 Regulatory corrections
1.3 March 2007 Update of procedures
1.4 October 2007 Update of procedures
2.0 April 2008 Update of procedure for deinstallation ISE
2.1 Sep 2008 Update of instrument placement & prep.
2.2 April 2009 New transport protection
Installation procedure ISE adjusted
3.0 September
2009
Document Part Number 04906900001
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
CH- 6343 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.
Generally remarks concerning Data base
and applications added (empty Database)
1.2 Copyrights and trademarks
cobas c
cobas c 111, and the R® logo are registered trademarks of F. Hoffmann- La Roche
cobas ccobas c
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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The following trademarks are acknowledged:
Adobe Acrobat, Linux, Microsoft Windows.
2008, F. Hoffmann- La Roche Ltd. All rights reserved.
1.3 Manufacturer
Manufacturer
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.
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz
Switzerland
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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 Volt- Amperes
VAC Volts (alternating current)
MΩ Megohm (106 ohms)
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Caution
Warning
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
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:
Indicates a direct danger that, if not avoided, may result in death or
Danger
General warning symbol on the analyzer
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.
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.
3.2 Safety 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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Danger
Warning
Warning
Electrical 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
Biological safety
Software virus warning
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
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.
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.
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
Diagnostics!
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
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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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Warning
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.
Any break in the electrical ground wire, whether inside or outside the analyzer, or disconnection of the electrical ground connection, may create a
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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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
handling
Memory DM- Module
Memory RT-CPU
Communication between
Communication between
Mass Storage
Interfaces (external)
Display 5.7 in. color LCD, (¼ VGA -
Printer Internal thermal printer (112
Samples
Incubation time Max. 12 min. / 40 cycles
Typical time to result ABS: 4 min. to 12 min.
Instrument cycle time 18 sec.
Reagent bottles
Calibration
Use of recommended QC
Cuvette handling
Measuring Unit
12 Wavelengths 340 nm ... 659 nm
Sensor Photosensitive diode array
Operating System LINUX
VX Works
32 MB Flash ROM
PXA 255
32 MB DRAM
32 MB Flash ROM
PXA 255
32 MB DRAM
2 MB SRAM
10/100 BaseT Ethernet
DM and RT
(for internal use only)
TegiLink Bus (RS485)
RT-CPU and µC boards
internal Flash ROM
external (data share) USB Memory Stick
2 x USB 1.1/2.0 Memory stick, Modem
2 x RS-232 - Host
- Barcode Reader
320 x 240 pixels); passive
matrix touch screen.
mm paper width)
Sample handling Direct tube placement
manually by user
ISE: 90 sec. (Na, K, Cl)
Content 20 ml maximum
Identification Barcode 2-d,
Format PDF417
Number of tests 50-200 depending of test
Use of Roche test-specific
CFAS, ISE Calibrator, etc.
calibrator fluids
PreciNorm, PreciPath, etc.
material
6 segments of 10 cuvettes
each. Single use only
Manual handling of cuvette
segments during standby.
Incubation Temperature 37°C ± 0.2°C
Absorbance photometer 20 W halogen lamp
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