The contents of this document may not be reproduced in any form or communicated to any third party without the prior written consent of Roche Diagnostics. While every effort is made to ensure its correctness, Roche Diagnostics assumes no responsibility for errors or omissions which may appear in this document. Subject to change without notice.
REF/No. 03273199001
Rev. 3.0, September 2002
First edition: October 2001
£*NQPSUBOUJOGPSNBUJPO£"MXBZTGPMMPX£
5IJTService ManualDPOUBJOTWJUBMwarning and safety information
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 1-I
1 Introduct ion
1-IIService Manual, Roche OMNI C, Rev. 3.0, September 2002
1 Introduction
1.1 General notes
This man ual con tains all of the information required for the maintenance and repair of the OMNI C.
You must be familiar with the fun ction and operation of the instrument to full y understand the
processes described here. Please refer to the OMNI C Instructions for Use or OMNI C Reference
Man ual for th is in forma tion .
Obser ve the s ervi ce an d repair pr ocedur es descr ibed i n th is manu al and use onl y genuin e Roche
replacement parts an d Roche-approved materials to guarantee the full functionality of your OMNI C.
For th e order number s of rep lacem ent part s, plea se ref er t o the OMNI C spar e part l ist.
Chapter 2 of this manual contains an overview of possible revisions and available software version s.
1.2 Symbols
1 Introduct ion
All sections or text passage s marked wi th this symbol describe
procedures that may involve risk of infection.
Sections marked wi th this symbol contain information that must be observed for the
prevention of personal injury to patients, users or third parties.
All sections or text passage s that are marked with this symbol describe procedures
and/or indicate conditions or dangers that could damage or lead to malfunctions in the
Roche OMNI C.
All sections or text passage s marked wi th this symbol refer to situations and/or
potential dangers affecting personne l performing the se rvicing or repair work.
All sections or text passage s marked wi th this symbol refer to components t hat require
special precautions related to e lectrostatic discharge. Pack aging marked wit h this
symbol may only be ope ned by trained personnel (also see page 1-6, section 1, ESD
protection measures)
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 1-1
1 Introduct ion
1.3 Importa nt note s and warni ngs
•Never use the analyzer near highly inflammable or explosive gasses (anaesthetic
gasses, e tc.).
• Use only 2-pin, grounded AC power sockets for the instrument.
• Ensure that the A C power cable and plug are in good condition.
Damaged AC cables or plugs must be replaced immediately.
•Switch the instrume nt off and unplug the AC power cabl e before opening its rear
panel.
• Be sure to replace blo wn fuses with new fuses of the same type.
• Always follow the i nstructions in this manual when servicing or repairing the
instrume nt.
• Always use suitable tools and testing equi pment for servicing or re pairs.
• To avoid damage t o the instrument's e lectronic components, prevent l iquids from
entering it.
•To clean the instrument, use lightly moistened tissue or cotton swabs.
1-2Service Manual, Roche OMNI C, Rev. 3.0, September 2002
1.4 Disinfectants
Use only liquid disinfectant suc h as Roche Deprote inizer or an alcohol -based (about
70%) surface disinfectant.
Do not use sprays, as they may enter the instrument and cause its electronic
components to malfunction.
Do not attempt to decont aminate any part of the instrument before shutting it down and
unplugging it from the AC power socket.
Before plugging the instrume nt back in and turning it on, always wait 15 minutes to
allow the disinfectant to ev aporate.
There is the risk of f ire or explosion especi ally in the vicinity of the power supply!
1.4.1 Roche Deproteinizer
1 Introduct ion
Composition
Aqueous NaOCl solution with active chlorine (≤ 2%)
Potential da ngers
Due to the alkaline and oxidizing character of this prepar ation, we cannot rule out local irritation to
the skin, eyes, and mucous membranes.
First aid measures
After in ha lati on: Fr esh a ir, drink larg e amount s of water
After skin con tact: Wash with large amounts of water, remove contaminated cloth ing
After eye con tact: Rinse with large amounts of water , con sult an eye specialist
After swallowing: Drink large amounts of water, do not induce vomiting, consult a physician
1.4.2 Commercial disinfectants
Use a comm erci al alcohol -based (70% ) di sinfect an t as a sur face dec ont amin ant. P lease ob serv e th e
relevant product information!
Do not use commercial disinfectants to decontaminate the tubing under any
circum stances!
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 1-3
1 Introduct ion
1.5 Decontamination
Use the following decontamination procedures to minimize the risk of infection (including hepatitis
and HIV) when r epla ci ng pa rt s th at h ave c ome i n con tact wit h bl ood or ot h er bi olog ica l l i qui ds.
Always wear gloves!
Observe section 1.4, Disinfect ants, on page 1-3.
1.5.1 Surfaces
Decon taminate all outside surfaces, including all covers (e.g. the measuring chamber cover, bottle
compartment cover , instrument cover) as well as the outside surfaces of the AutoQC module if
presen t, with a cl oth m oisten ed with disin fecta nt.
1.5.2 Touch screen
1. Select
"Mo re functio ns – System – Wash and clean – Clean screen".
The touch screen will be disabled for 30 seconds.
The remaining number of seconds will be displayed on the screen.
2. You may n ow clean th e screen with a cl oth m oist ened wit h dis infecta n t.
3. After 30 seconds have elapsed, the menu will reappear.
1.5.3 Barcode scanner
Decont am inat e the outer sur faces of t he ba rcode sca nn er wi th a cl oth moi sten ed with disin fecta nt.
1-4Service Manual, Roche OMNI C, Rev. 3.0, September 2002
1.5.4 Sample port module
1. Select
"Mo re functio ns – System – Wash and clean – Clean sampl e port modul e".
2. Open the flap completel y (capillary position).
3. Remove t he sa mple dr ip tr ay and decont amin ate i t usin g a cotton swab dip ped i n di sinfect an t.
If the sample drip tray is heavily contaminated, replace it with a new one.
Before r epl acin g it, decont amin ate th e samp le dr ip tray with a cott on swa b dipp ed in
disinfectant.
4. Open the bottle compartment cover.
5. Remove t he red tube con nect or fr om th e wash p late.
6. Push the wash plate down to unlock and pull it out.
(The was h pla te is l ocked a nd cann ot be r emoved when the pl ug is in sert ed.)
7. Decontaminate the wash plate with a cotton swab dipped in disin fectant.
8. Push the wash plat e back in complet el y and at tach the tube p lug.
9. Push the drip tray in.
10. Decontaminate the fill port and the visible part of the needle with a cotton swab dipped in
disinfectant.
11. Close the flap to the syringe position (half-opened position).
12. C lean the ti p of the n eedle.
13. C lose th e fla p.
14. Close the bottle compartment cover.
1 Introduct ion
1.5.5 Measuring chamber
1. Remove t he in str ument cover an d open the mea surin g ch amber co ver.
2. Open th e elect r ode locki ng lever an d rem ove the el ectr odes.
3. Clean the mea surin g ch amber wi th a t owel soak ed in disin fecta nt ( e.g. Roch e Depr otein iz er).
4. Reinser t th e el ectr odes.
5. Close th e mea sur ing cha mber cover an d repl ace th e inst rum ent cover .
1.5.6 Tubing paths
To decontaminate the tubing system, use Roche Deproteinizer only!
Press
"Mo re functio ns – System – Wash and clean – Automatic rou tin es – Decontaminat e all
tubes" and follow th e on- screen instr uct ion s.
For a detailed descr iption of this procedure, please refer to section 6.1, Decontamination,
in th e Roche OMNI C Ins tru ction s for Use.
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 1-5
1 Introduct ion
1.6 ESD pr otec tion me asur es
ESD protection measures are designed to prevent electronic components from being
damaged or destroyed by uncont rolled electrostatic discharges.
1.6.1 Causes of electrostatic charges
The most frequent causes of electrostatic charges are friction or the separation of various materials
such a s pla sti cs, synt h eti c fi bre s, har d ru bber or p ap er, or el ectr on bea ms i n CRT uni ts .
They can also be ca used with in an object by flexur e or pressu re – such a s the fr icti on of in dividu al
fibr es with in a pi ece of fa bric.
The resu ltin g el ectri cal voltag es ma y become a h azar d when "char ged" bodi es or com pon en ts do not
have a conductive connection permitting a discharge (poten tial equalization).
The resulting charges generally do not have high energy, but nevertheless may have differences in
poten tial of several thousan d volts, resulting in perceptible electr ic shocks or visible sparks.
Example:
•Shoes with rubber soles:
The friction of walking charges th e per son wearing the shoes in relation to the floor. A
disch arg e occurs when the per son tou ches an object.
•Cloth ing made of syn thetic fabrics:
Audibl e disch ar ge; sp arks vi sible i n th e dark.
• The formation of electrostatic charges through friction is promoted by dry air.
• This tendency is reduced in high humidity, especially in saturated air.
• The occurrence of electrostatic phenomena is thus especially pronounced in the
winter (northern hemisphere) in centrally heated rooms with low humidity.
1.6.2 Effects of ESD on electronic components
When an electr osta ti cally cha r ged per son t ouches an electr on ic devi ce, th e disch ar ge may ta ke pl ace
via t he pin s of an IC or a s emi con du ctor com pon ent . If a di scha rg e t o grou n d is p ossi ble, t he
resulting voltage may damage the component.
This would be th e case, for ex amp le, if th e uni t has a conn ecti on t o a protect ive g roun d – thi s
therefore also applies to uni ts that are switch ed off, but have th eir AC cables pl ugged in.
Critical situations may also occur when repairing or testing electronic assemblies if they are placed
on a mor e or less condu ctive su rfa ce (e.g . ta ble top ) and ar e touch ed b y an elect rost ati call y char ged
person . In this case, the discharge may also take place via a critical component con nection.
1-6Service Manual, Roche OMNI C, Rev. 3.0, September 2002
1.6.3 Why is ESD protection so important today?
In th e past, cu rren t-con tr ol semi condu ctor s (TTL, norma l trans istor s, etc. ) wer e most com monl y
used.
Toda y, the pr inci pl e of volta ge cont rol is used a lmost exclus ivel y in MOS an d CMOS comp onen ts
that are thus highly sensitive to the effects of externally applied voltages.
The voltages occurring in electrostatic discharges (up to sever al kV!) damage or destroy t he
sensitive component inputs.
An additional factor is the shrinking in ternal dimensions of ICs.
With the decreasing size of the internal con ductor s, the permissible maximum input voltages are
also becoming lower and the effects of electrostatic disch arges th us becoming ever more critical.
1.6.4 How can ESD protection be guaranteed?
A contin uous disch ar ge must be ensur ed when han dling el ectr oni c assem blies.
This can be accomplished as follows:
•When tran spor tin g electr on ic assem blies, be sur e to use E SD prot ecti on pa ckag ing
sui ta ble s tor ag e/ shi pp ing pa ck ag ing ( i. e. th e or ig ina l pac ka gin g ma ter ia l).
• Test and r epair elect roni c ass embli es onl y on tabl es wi th ESD mats
• Wear a grou nded ESD wri st str ap.
• Han dle electronic components/assemblies by the edges only. Avoid touch ing printed circuits or
compon ent p ins .
•Do n ot wear shoes with r ubber soles or items of cloth ing containing syn thetic fibres in facilities
in whi ch elect r onic equ ipm ent is ser viced .
• If necessa ry, u se a hu midi fier to en sur e optimal humidity (>20% rel.) in the room.
• Take care not to touch assemblies or individual compon ents directly with your han d after
testing.
•When sen ding el ectr onic com ponen ts or assem blies i n for r epair s, alwa ys use E SD pr otecti on
packaging
of the fault.
1
to preven t fur th er dama ge that ma y resul t in an incorr ect int erpret ati on of th e cau se
1 Introduct ion
1
or oth er
1
.
1.6.5 Conclusion
Natur all y, not al l prin ted circu it boar ds and elect roni c assem blies requ ire s uch car eful trea tment . An
assembly that featur es simple plug con nectors, for example, is insensitive to electrostatic discharge
and th erefor e does n ot n eed ES D protecti on p acka gin g.
When in doubt , however, always take ESD pr ecautions!
1
These a re materi als w ith a ve ry lo w , defined co nduc tivity (10
cannot damage components.
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 1-7
12
ohms), which do not accumulate charges with friction and thus
1 Introduct ion
1-8Service Manual, Roche OMNI C, Rev. 3.0, September 2002
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 2-I
2 Revisions
2-IIService Manual, Roche OMNI C, Rev. 3.0, September 2002
2 Revisions
2 Revisions
2.1 Software
Version Nr. Date of Release Remark Installed from OMNI C Serial Nr.
1.01 15.10.2001 First Release
1.22 15.02.2002
1.33 06.12.2002
≥1000
≥1251
≥1558
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 2-1
2 Revisions
2.2 Service Manual
2.2.1 Revision 1.0
Revision Nr. Date of Release Modified Chapters Applicable from Software Version
1.0 October 2001 First Release 1.01
2.2.2 Revision 2.0
Revision Nr. Date of Release Modified Chapters Applicable from Software Version
2.0 January 2002 2, 3, 6, 8, 9 1.22
Chapter-Page Modifica tion / Addition
Cover Page Revision No. and Dat e
2-I Table of contents
2-1 Revision List
3-II Table of contents
3-34 Changi ng the MBX board battery
6-I Table of contents
6-1 Password
6-3 Delete databases
6-3 – 6-4 Reset set tings
6-12 Consequence ac tion delay
6-13 – 6-14
6-15 Boot parameters
6-16 Database
8-I – 8-II Table of contents
8-1 – 8-9 System Stops
8-10 – 8-18 Error Messages
8-21 Leaks in the Sample port / Needle / Barex tube area
8-22 Electrode limit values
8-22 – 8-23 Contact path limi t values
9-1 – 9-6 Index
Log unit
2-2Service Manual, Roche OMNI C, Rev. 3.0, September 2002
2 Revisions
2.2.3 Revision 3.0
Revision Nr. Date of Release Modified Chapters Applicable from Software Version
3.0 September 2002 2, 5, 6, 8, 9 1.33
Chapter-Page Modifica tion / Addition
Cover Page Revision No. and Dat e
2-I Table of contents
2-3 Revision List
5-I Table of contents
5-13 Cal ibrating the Sample Sensors
5-15 Calibration Flow Chart
5-19 Measurement procedure
5-21 System c alibration procedure
6-I Table of contents
6-2 Roche Servic e 1 – new Screenshot
6-5 AQC XY adjustment
6-7 Calibration of tHb temperature sensor
6-15 Start button for measurement
6-20 O2 zero interval
8-II Tabl e of c ontents
8-10 Error Messages
8-10 Li st of error messages (sorted by Inf o No.)
8-23 Electrode calibration limit values
8-23 Conductivity calibration limit values
8-24 Conductivity calibration limit values
8-25 Power-up component test
9-1 – 9-6 Index
Additional page Start button for measurem ent
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 2-3
2 Revisions
2-4Service Manual, Roche OMNI C, Rev. 3.0, September 2002
3.19.1 General Information.........................................................................................3-53
3.19.2 Testing the barcode scanner ............................................................................3-54
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 3-III
3 Components
3-IVService Manual, Roche OMNI C, Rev. 3.0, September 2002
3 Components
3.1 Important Instructions
Components of the OMNI C (sample port, tubing, Waste container, et c.) contain
remnants of biological fluids afte r use, resulting in possible risk for infections.
Handle these components with care and avoid skin contact.
Wear rubber gloves while working on the analyzer!
The tubes may drip a little after being disconnected.
Remove excess fluids with a clean, absorbent cloth.
After changing components, cali bration parameters coul d have changed or some values
have to be entered again.
After finishing modifications, a system calibration must be performed to adapt the
calibration parameters to the new conditions.
3 Components
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 3-1
3 Components
3.2 Shutdown
Switch off the OMNI C before you begin with the modifications!
Determined by the time the analyzer was switched off, one of the following procedures
has to be performed:
3.2.1 The OMNI C stays switched off shorter th an 24 hours
• Perf orm th e decont amin ati on pr ocedur e accor din g to secti ons 1.5. 1 to 1.5.6 on page 1-4.
• Press „More - Syst em – Tools– S oftware communi cation – Shu t down software“
and swi tch off the an alyzer
If the Docking mechanisms C1, C2 or C3 have been opened while the analyzer was
switched off, the respective soluti ons have to be prepared again under „More - System – Tools– Fluid actions – Auto preparation routines“ to avoid improper
operation!
3.2.2 The OMNI C stays switched off longer than 24 hours
• Perf orm th e decont amin ati on pr ocedur e accor din g to secti ons 1.5. 1 to 1.5.5 on page 1-4.
• Press „More - Syst em – Tools- Shutdown“ an d foll ow the in str ucti ons on the scr een.
Only Roche Deproteinizer may be used for the decontamination of the tubing.
3-2Service Manual, Roche OMNI C, Rev. 3.0, September 2002
3.3 Dismounting the rear panel
1. Switch off the OMNI C (please pay atten tion to section 3.2 Sh utdown on page 3-2!).
2. Pull off the power cord from the power supply unit.
3. Remove t he thr ee m ountin g scr ews from the r ear pan el (s ee Fig. 3-1 ) and pul l off th e rear p anel
from the analyz er (if needed, remove the power supply unit from the rear panel; a certain
amoun t of force i s n eeded beca us e of th e mount ing wit h Vel cro t ape).
1
3 Components
2
3
Fig. 3- 1 O MNI C r ear p anel mou nti ng scr ews
4. Pull off the plug of the power supply cable from the PC tower (see Fig. 3-2).
Fig. 3-2 Plug of the power supply cable
Assembly is done in reverse order.
Service Manual, Roche OMNI C, Rev. 3.0, September 2002 3-3
3 Components
When installing the rear panel, please pay attention to the correct routing of the power
supply cable inside the OMNI C (see Fig. 3-3)!
Fig. 3- 3 R out ing of t he p ower su ppl y c able
3-4Service Manual, Roche OMNI C, Rev. 3.0, September 2002
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