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cobas c

 111 Installation Manual 

 

 

 

 

04906900001  

INSTALLATION-MANUAL 

cobas c

 111

 

Version 3.0 

Page 8 of 43

 

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 
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. 

 

Biological safety 

 

 

Liquid  waste  and  cuvette  waste  are  potentially  biological  hazar-
dous.  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  dis-
infectant. 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 
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 

 

 

Instrument Service & Maintenance 

The 

cobas c

 111 is an electromechanical device that has no internal electrical parts ser-

viceable by the user. For preventive maintenance, contact your Roche Service represen-
tative 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. 

 

Danger

 

Warning 

Warning 

Содержание Cobas C111

Страница 1: ...04906900001 INSTALLATION MANUAL cobas c 111 Last printed 7 January 2010 Page 1 of 43 R Installation Manual Version 3 0 29 Sep 2009...

Страница 2: ...cobas c 111 Installation Manual 04906900001 INSTALLATION MANUAL cobas c 111 Version 3 0 Page 2 of 43 This page has been left empty intentionally...

Страница 3: ...ation 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...

Страница 4: ...0001 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...

Страница 5: ...gnostics Ltd Forrenstrasse CH 6343 Rotkreuz Switzerland 1 4 Intended use The cobas c 111 instrument is a continuous random access analyzer intended for the in vitro determination of clinical chemistry...

Страница 6: ...bol 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 ar...

Страница 7: ...lowing signs and their meanings 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...

Страница 8: ...vide 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 Diagn...

Страница 9: ...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...

Страница 10: ...aining 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 wh...

Страница 11: ...lume per test from 2 15 l 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 reag...

Страница 12: ...cobas c 111 Installation Manual 04906900001 INSTALLATION MANUAL cobas c 111 Version 3 0 Page 12 of 43 4 2 Instrument internal layout The major components of the analyzer are shown below in fig 1...

Страница 13: ...D VGA 320 x 240 pixels passive matrix touch screen Printer Internal thermal printer 112 mm paper width Samples Sample handling Direct tube placement manually by user Incubation time Max 12 min 40 cycl...

Страница 14: ...e con This unit must be connected to a grounded mains outlet nected to a grounded mains outlet nected to a grounded mains outlet nected to a grounded mains outlet Insulation coordination Category II I...

Страница 15: ...Union EU Directive 98 79 EC in vitro medical device FCC This equipment complies with the requirement in part 15 of FCC rules for a class A computing device Operation of this equipment in a residential...

Страница 16: ...f this document 5 1 1 Packing list The actual version of the analyzer as delivered together with a list of the accessories for your configuration are detailed in the accompanying packing list That lis...

Страница 17: ...he warranty on the analyzer The original shipping containers must be transferred unopened to the installation site Unpack the instrument and check that all items mentioned on the packing list are pres...

Страница 18: ...ON MANUAL cobas c 111 Version 3 0 Page 18 of 43 2 Remove the standard accessories 3 Lift the carton off the pallet to get access to the instrument 4 Remove the upper cardboard cover 5 Remove the plast...

Страница 19: ...111 on flat and stable surface Notice Keep the packing pieces in a safe place to use again whenever the instru ment has to be transported any significant distance 5 3 2 Unpacking procedure for instrum...

Страница 20: ...on off the pallet to get access to the instrument 4 Remove the upper cardboard cover 5 Remove the plastic transport protection covering the instrument 6 Lift the cobas c 111 instrument from the pallet...

Страница 21: ...the rear of the instrument Important Only use an approved power supply cord in good condition Do not touch mains cables if your hands are wet Do not attempt to connect or disconnect the mains cables...

Страница 22: ...22 of 43 RS232 Serial connectors There are 2 serial interface connectors intended for use with a Barcode scanner and Host interface respectively Please refer to the cobas c 111 Operator Manual and the...

Страница 23: ...Operator s Manual Notice If there is a Reagent Disk inside but is not detected by the software then check for correct identification by the flags Exactly one of these flags needs to be broken away for...

Страница 24: ...p watch the valves to operate correctly 18 Check if the peristaltic pump cover is closed 19 Use the maintenance action Prime ISE calibrator and reference to prime the tubing 20 Use the maintenance act...

Страница 25: ...ation report form Any factory set calibration data found on the instrument may be outdated and therefore cause wrong results Cross check the calibration results and the application producing correct r...

Страница 26: ...ide of the instrument Place a new bottle of cleaner fill the Water Container with de ionized water CLSI Grade II and check that the Waste Container is empty 7 As next step Connect the Cleaner Protecti...

Страница 27: ...ter when delivered eventually an error message Air detected in the fluid system will appear Ignore it until you performed step 6 Otherwise you have to check the fluid tubing for leaks 5 Check the Reag...

Страница 28: ...tion result for the CHECK test that is stored in the database can not be deleted as it is always used as reference 10 Reset Maintenance Counter Please choose Utilities Diagnostics Analyzer Installatio...

Страница 29: ...cover 5 Remove the screws on the left and right side that holds the rear service flap and fold it backwards 6 Remove the complete ISE Cover and left side panel of the ISE unit 7 Route the flat ribbon...

Страница 30: ...INSTALLATION MANUAL cobas c 111 Version 3 0 Page 30 of 43 9 Connect the flat ribbon cable to the PCB ISE Controller J2 10 Remove the power box guard plate ISE Module fixation screws Flat ribbon cable...

Страница 31: ...0001 INSTALLATION MANUAL cobas c 111 Version 3 0 Page 31 of 43 11 Connect the ground strap using the provided screw and serrated lock washer 12 Connect the waste tube to the corresponding plug ISE gro...

Страница 32: ...ap into normal position and fix it with the 2 screws 16 Put the right side panel back into place 17 If not yet mounted fix the air tube to the mixtower socket Mount the sample inlet tube to the socket...

Страница 33: ...to the rear connector of the internal waste tank 20 Finally mount the waste tube to ISE tower mount the tower itself and lock the ring Apply the overflow adapter at the end 21 Connect the ISE power s...

Страница 34: ...9 1 Drain the instrument with ISE of water and cleaner 1 Perform the Diagnostic function Drain ISE Unit follow its instructions 2 Store the valve caps and clamps and the electrodes in separate bags a...

Страница 35: ...age 35 of 43 9 3 Packing procedure for instrument with ISE Notice Use only the original packing pieces to prevent any damage of the instrument Notice The packing instructions are also shown on a label...

Страница 36: ...strument and place it into the cellular material Caution The instrument weighs around 38 kg 80 lbs 3 Apply the protection plastic foil and the plastic bag over the transfer head 4 Set up the left and...

Страница 37: ...L cobas c 111 Version 3 0 Page 37 of 43 5 Impose on the surrounding carton 6 Put on the cardboard cover Packed in surrounding carton Transfer head protection Make sure to have the transfer head protec...

Страница 38: ...ttles into the other box 8 If the TIP N TELL indicator applied on the cardboard cover iniside box and outside are still ok leave them otherwise cancel the corresponding one with a pen 9 If possible ap...

Страница 39: ...es to prevent any damage of the instrument Notice The packing instructions are also shown on a label outside of the box 1 Start with preparing the palette 2 Lift the cobas c 111 instrument and place i...

Страница 40: ...sfer head Set up the left and right protection pieces just turn the one on the left side by 180 degrees 4 Impose on the surrounding carton 5 Put on the cardboard cover Instrument with protection plast...

Страница 41: ...fluid bottles into the other box 7 If the TIP N TELL applied on the cardboard cover inside box and outside are still ok leave them otherwise cancel the corresponding one with a pen 8 If possible appl...

Страница 42: ...d out wheeled bin symbol are covered by the European directive 2002 96 EC WEEE These items must be disposed of via designated collection facilities appointed by government or local authorities WEEE Di...

Страница 43: ...Date Country City Responsible FSE Main Power Supply Voltage Frequency Subject Not OK OK Comments Package Accessories Chassis Housing Robotic Transfer Fluid Pipetting Internal Printer Analyzer Assembly...

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