Roche OMNI C User manual

Roche OMNI C
Instructions for Use
POINT OF CARE
TESTING
Ident.Nr.: =PD0087=
Druckvorlage: ____.__A/M__J_
Änderungsstand: SP/0132
Bezeichnung: Titelblatt OMNI C
Instruction for Use
Druckvorlagenherstellung: fa. pupo

Roche Diagnostics GmbH
D-68298 Mannheim / Germany
www.roche.com
Copyright © 2002 Roche Diagnostics GmbH, all rights reserved
The contents of this document may not be reproduced in any form or communicated to any third party without the prior writ-
ten consent of Roche Diagnostics. While every effort is made to ensure its correctness, Roche Diagnostics assumes no respon-
sibility for errors or omissions which may appear in this document. Subject to change without notice.
REF/No. 03260992001
Rev. 4.0, December 2002
First edition: October 2001

– Important information! – Always follow! –
These Instructions for Use contain vital warning and safety information.
This instrument is intended to be used only for the specialized purpose described in the instructions. The
most important prerequisites for use, operation, and safety are explained to ensure smooth operation. No
warranty or liability claims will be covered if the instrument is used in ways other than those described or if
the necessary prerequisites and safety measures are not observed.
The instrument may be operated only by persons whose qualifications enable them to comply with the safety
measures that are necessary during operation of the instrument.
Adjustments and maintenance performed with removed covers and connected power may be attempted only
by a qualified technician who is aware of the associated dangers.
Instrument repairs are to be performed only by the manufacturer or qualified service personnel.
Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument.
These items are manufactured especially for use with this instrument and meet the highest quality require-
ments.
Operation of the instrument with solutions whose composition is not consistent with that of the original
solutions can negatively affect, above all, the long-term measurement accuracy. Deviations in the composi-
tion of the solutions can also decrease the service life of the electrodes.
The quality control requirements must be completed at least once daily for safety reasons. Because accurate
measurement results depend not only on the proper functioning of the instrument, but also on a number of
other factors (such as preanalytics), the results produced by the instrument should be examined by a trained
expert before subsequent decisions are reached that are based on the measurement values.
Explanation:
Meaning: "Caution, refer to accompanying documents“.
– Important information! – Always follow! –

– Operating safety information –
•The instrument has been constructed and tested according to the protective measures stipu-
lated by EN 61010-1: 1993 / IEC 1010-1 for electrical measurement, control, IVD, and labo-
ratory instruments and was delivered from the factory in flawless condition with regards to
safety features. In order to preserve this condition and ensure safe operation, the user must
respect the notices and warnings that are contained in these Instructions for Use.
•This instrument is classified under the protection class I according to EN 61010-1 / IEC
1010-1.
•The instrument meets the conditions for overvoltage category II.
•The instrument meets the conditions for contamination level 2.
•Do not operate the instrument in an explosive environment or in the vicinity of explosive
anesthetic mixtures containing oxygen or nitrous oxide.
•If an object or liquid enters the internal areas of the instrument, remove the instrument
from its power supply and allow an expert to check it thoroughly before using it again.
•The instrument is suitable for long-term operation indoors.
CAUTION:
•The power cord may be plugged into a grounded socket only. When using an extension
cord, make sure it is properly grounded.
•Any rupture of the ground lead inside or outside the instrument or a loose ground connec-
tion may result in hazardous operating conditions. Intentional disconnection of the
grounding is not permitted.
•The instrument is not suitable for operation with a direct current power supply.
Use only the original mains plug delivered with the Roche OMNI C.
– Operating safety information –

3 Calibration
2 Specifications
1 Introduction
4 Measurement
5 Quality Control
6 Maintenance
7 Trouble shooting
8 Operating Modes
9 Index

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-I
1 Introduction
1.1 General notes ................................................................................................................... 1-2
1.1.1 Application area.............................................................................................................................................1-2
1.1.2 Operating instructions.................................................................................................................................1-2
1.1.3 Symbols.............................................................................................................................................................1-3
Used in the Instructions for Use ...............................................................................................................................1-4
1.2 Measurement and calibration procedure .................................................................. 1-5
1.2.1 Measurement procedure............................................................................................................................1-5
1.2.2 Calibration procedure..................................................................................................................................1-5
1.3 Measurement evaluation .............................................................................................. 1-5
1.4 Safety instructions for specific dangers .................................................................... 1-6
1.4.1 Handling samples..........................................................................................................................................1-6
1.4.2 Disposal of waste water, bottles, electrodes, and the instrument ..............................................1-6
1.4.3 Decontamination ...........................................................................................................................................1-6
1.5 Handling solutions ..........................................................................................................1-6
1.6 Handling electrodes ....................................................................................................... 1-7
1.7 System description ......................................................................................................... 1-7
1.7.1 Visual identification ......................................................................................................................................1-7
1.7.2 Screen................................................................................................................................................................1-8
Parameter – Display on the "Ready" screen ........................................................................................................1-8
Parameter – notation of the measurement, input, and calculation values ...............................................1-9
Buttons ............................................................................................................................................................................ 1-12
1.7.3 Printer ............................................................................................................................................................. 1-13
1.7.4 Measurement chamber............................................................................................................................ 1-13
1.7.5 Pump ............................................................................................................................................................... 1-13
1.7.6 Flap .................................................................................................................................................................. 1-13
1.7.7 Bottle compartment................................................................................................................................... 1-13
1.7.8 Power supply................................................................................................................................................ 1-13
Position of the mains switch ................................................................................................................................... 1-13
1.7.9 Reverse side ................................................................................................................................................. 1-14
Interface .......................................................................................................................................................................... 1-14

1 Introduction
1-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
COM 1 ............................................................................................................................................................................. 1-14
COM 2 ............................................................................................................................................................................. 1-14
Barcode scanner ......................................................................................................................................................... 1-15
Warning and identification labels ......................................................................................................................... 1-15
1.8 Installation ...................................................................................................................... 1-16
1.8.1 Installation.....................................................................................................................................................1-16
Location .......................................................................................................................................................................... 1-16
Accessories ................................................................................................................................................................... 1-16
1. Attach power cord and barcode scanner ..................................................................................................... 1-17
2. Installing the AutoQC module (Automatic Quality Control Module) .................................................. 1-18
3. Switch on ................................................................................................................................................................... 1-20
4. Select language ...................................................................................................................................................... 1-20
5. Setting the date and time .................................................................................................................................... 1-20
6. Checking the barometer value .......................................................................................................................... 1-20
7. Checking the AutoQC module .......................................................................................................................... 1-20
8. Installation ................................................................................................................................................................. 1-21
9. Check tubes at V2 and V9 .................................................................................................................................. 1-21
10. Insert FMS tubes .................................................................................................................................................. 1-22
11. AutoQC module (option) ................................................................................................................................... 1-22
12. Attach pump tube ................................................................................................................................................ 1-22
13. Insert needle and fill port holder ................................................................................................................... 1-23
14. Insertion of printer paper .................................................................................................................................. 1-23
15. Insertion of bottles ............................................................................................................................................... 1-24
16. Insert electrodes ................................................................................................................................................... 1-25
17. Insertion of the reference electrode ............................................................................................................. 1-26
18. Begin installation routines ................................................................................................................................ 1-28
19. Quality control ....................................................................................................................................................... 1-28
1.9 Shutdown ........................................................................................................................ 1-29
1.9.1 Less than 24 hours.....................................................................................................................................1-29
1.9.2 Longer than 24 hours................................................................................................................................1-29
1. Remove bottles ........................................................................................................................................................ 1-29
2. Remove the V2 and V9 tube ends from the guides .................................................................................. 1-29
3. Insert the shutdown kit and connect it .......................................................................................................... 1-30
4. Remove the shutdown kit. .................................................................................................................................. 1-31
5. Remove the waste water bottle ........................................................................................................................ 1-31
6. Return the V2 and V9 tube ends to the guides .......................................................................................... 1-31
7. Remove the pump tube ....................................................................................................................................... 1-31
8. Remove the electrodes ......................................................................................................................................... 1-32
9. Remove needle and fill port ............................................................................................................................... 1-32
10. Remove the printer paper ................................................................................................................................. 1-33
11. Remove the tube under V1 and V2 ............................................................................................................... 1-33
12. Shutting down the AutoQC module ............................................................................................................. 1-34
13. Uninstall the AutoQC module ......................................................................................................................... 1-34

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-1
1 Introduction
Fig. 1
The Roche OMNI C is a modular analyzer for measuring blood gases, electrolytes, total
hemoglobin, oxygen saturation and hematocrit in whole blood, serum, plasma, acetate and
bicarbonate containing dialysis solutions, and QC materials.
It is possible to complete database procedures or to make simultaneous adjustments during
measurement or calibration.
The individual, mutually independent operating modes are defined as follows:
a) Analyzer: measuring, QC, system, calibration, commonly used functions
b) Database: data about patients, measurement, calibration, QC, and the instrument
c) Setup: instrument settings
d) Info: Roche info, version number, fill levels, help, sensor report
The Roche OMNI C is currently available in the following configuration:
•BG (pH, PO2, PCO2) / ISE (Na+, K+, Cl–, Ca2+) and tHb/SO2
A new and patented fluid calibration system eliminates the need for expensive calibration
gases. This change results in easier handling, a smaller footprint, and reduced costs.
An easily understood "Touch Screen" interface facilitates easy operation and saves costly
and time-consuming user training.
The patented electrodes are completely maintenance-free, and only require a very small
sample volume.

1 Introduction
1-2 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
1.1 General notes
1.1.1 Application area
The instrument is designed to measure BG / ISE / tHb/SO2in whole blood. The accuracy of
measurement values is checked accordingly.
In order to achieve accurate measurements of recommended aqueous control solutions
(with regards to deviations from biological samples), choose the proper components and
make the corresponding corrections in the QC measurement mode.
The accuracy of measurement values of undefined aqueous solutions cannot be guaranteed
(e.g. due to the possibility of interfering components and/or missing or insufficient buffer
systems, and/or differences in ionic strength and diffusion potential when compared to bio-
logical samples).
1.1.2 Operating instructions
The Roche OMNI C should be enabled at all times!
If the instrument will remain turned off for longer than 24 hours, it is necessary to carry out
shutdown procedures (for more information, please see chapter 1.8, "Installation" and 1.9
"Shutdown").
Prevent fluids leaking inside the analyzer.
Complete at least one quality control test every day (please see chapter 5, "Quality Control",
for more information) in order to quickly recognize error functions in the Roche OMNI C.

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-3
1.1.3 Symbols
This product fulfils the requirements of the Directive 98/79/EC on in vitro
diagnostic medical devices.
Lot number
Expiry date
Electrodes: use by..
(The electrode must be inserted before the indicated date, but
can remain in the instrument after the date)
Solutions: use by..
(The solution must be completely consumed by the indicated
date)
If a day is not indicated, apply the last day of the respective month.
Storage note:
The conditions necessary to preserve the product's shelf life before opening.
For in vitro diagnostic use
Danger symbol: "Irritant" (on the label and packaging of the C3 solution)
Rating: Although not corrosive, momentary, longer-lasting, or repeated
contact with skin or mucous membrane may result in inflammation. Danger
of sensitization during contact with skin (when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale vapours.
"GreenDot" (in Germany)

1 Introduction
1-4 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
Manufacturer—according to IVD guidelines
Store upright
(according to the standards IEC 61010-2-101)—Risk of Infection!
Reference and/or catalogue number
CAUTION: refer to accompanying documentation!
Please read pack insert / instructions for use
Serial number (model plate)
Used in the Instructions for Use
All sections / passages that are marked with this symbol (refer to Instructions for
Use) describe information to avoid possible potential for personal injury (for
patients, user or third person).
Risk of infection!
All sections / passages that are marked with this symbol describe procedures and/or
indicate conditions or dangers that could damage or lead to a malfunction in the
Roche OMNI C, and which therefore should never be attempted.
TIP: All sections / text locations marked with "TIP" describe safe procedures that are
intended to provide the user with additional "Help."
=

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-5
1.2 Measurement and calibration procedure
1.2.1 Measurement procedure
Use the following procedures to calculate the various measurement variables:
PO2: Use of the Clark measurement principle: measurement of current generated by the
reduction of oxygen
PCO2: Use of the Severinghouse principle: potentiometric measurement of the pH change
in the electrode caused by CO2.
pH-, Na+-, K+-, Ca2+- and Cl–are potentiometric electrodes. Special glasses are used as the
sensitive element for pH and Na+. The potassium and calcium membranes contain special
neutral carriers. A special ion exchanger is used for chloride membranes. Calculation of
these variables also requires the use of a reference electrode—a permanently contacted chlo-
ride electrode in the Roche OMNI C.
tHb /SO2: Light absorption in whole blood is measured at four different wavelengths,
whereby on one hand the sample is subjected to light radiation and on the other hand the
dispersed light is also evaluated.
Hematocrit : Measurement of the sample's conductivity
1.2.2 Calibration procedure
tHb and SO2are calibrated when the instrument is calibrated. Ambient air and a zero point
solution are used to calibrate oxygen. The remaining parameters are calibrated with the help
of two solutions, which are mixed in various ratios. Gas containers are not used. The use of
at least two calibration points for each measurement variable and constant internal moni-
toring of the calibrations ensures the accuracy and precision of the measurement values.
1.3 Measurement evaluation
The validity of the test results from the Roche OMNI C must be carefully examined by a clin-
ical-medical specialist who will take the patient's clinical condition into consideration
before any clinical decisions are reached based on the test results.
To ensure the quality of the measurement results, a quality control must be performed on
3 levels (low, normal, high) at least once daily, or more frequently depending on local reg-
ulations, after each electrode exchange and after the startup of the instrument (for detailed
information see chapter 5 "Quality Control").

1 Introduction
1-6 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
1.4 Safety instructions for specific dangers
1.4.1 Handling samples
Respect the necessary hygienic regulations when handling samples because samples may
contain dangerous viruses.
For more detailed information, please see chapter 4, "Measurement."
1.4.2 Disposal of waste water, bottles, electrodes, and the instrument
Dispose waste water, bottles, electrodes and the instrument according to local and/
or labour regulations (biologically contaminated—hazardous waste!)
1.4.3 Decontamination
The purpose of this procedure is to minimize risk when handling items that were in contact
with biological samples.
Roche recommends following a decontamination procedure in addition to regulations spe-
cific to the laboratory.
These decontamination procedures should be performed periodically to minimize the risk
of infections (incl. hepatitis virus and HIV).
Always wear gloves!
For more detailed information about decontamination, please see chapter 6, "Mainte-
nance."
1.5 Handling solutions
Store the OMNI C solutions according to the specified packaging requirements. The solu-
tions should be adapted to the ambient temperature before use.
The shelf life of the solutions is limited.
Please read the bottle label and the packaging for the correct storage temperature and the
maximum shelf life.
CAUTION! DO NOT FREEZE!
If frozen, the solution's concentration may change and cause calibration errors!
Do not use damaged C3 fluid packs! Do not mix the individual components!

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-7
1.6 Handling electrodes
Store the electrodes according to the packaging specifications.
The shelf life of the electrodes is limited.
Please see the electrode label and the packaging for the correct storage temperature and the
maximum shelf life.
TIP: IMPORTANT! Installation note for the PCO2electrode
Insert the electrode into the measuring chamber within 5 minutes of opening the ALU-
PE packaging.
A special protective gas atmosphere designed to condition the PCO2electrode during
storage is found inside the ALU-PE packaging.
This gas atmosphere ensures immediate potential stability during insertion of the elec-
trode into the measurement chamber and/or immediate readiness for measuring after
the 2 point calibration is completed.
If more than 5 minutes elapse after opening the ALU-PE packaging, the level of gas
conditioning could be lost and the time required for the first-time calibration could be
increased.
1.7 System description
1.7.1 Visual identification
Fig. 2
screen
reverse side
printer cover
flap
bottle compartment
cover
power pack /
mains switch
unlocking knob
for the AutoQC
module
contrast setting
measurement chamber with
electrodes and tHb/SO2module
Pump

1 Introduction
1-8 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
1.7.2 Screen
All information (results, error messages, warnings, etc.) is displayed on the screen. The
screen consists of a 5.7" colour LCD that is covered with a touch-sensitive film ("touch
screen").
Fig. 3
Please refer to the respective chapters in these Instructions for Use as well as the Reference
Manual for more detailed information about the operating modes.
Parameter – Display on the "Ready" screen
Depending on the settings and the status of the instrument, the parameter buttons may have
the following appearance:
* Pressing the parameter button produces a status report (see chapter 7, "Trouble shooting",
section "Electrode status").
Parameter activated and ready Parameter not ready
(not calibrated)*
Parameter temporarily deactiva-
ted (but calibrated)
Parameter not ready
(due to QC lock)
Parameter activated with QC
warning
Parameter not ready due to remote
lock
Parameter temporarily deactiva-
ted with QC warning
Parameter permanently deactiva-
ted (under "Setup")
operating mode
selection button
status line
additional
functions
parameter status
and selection

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-9
Parameter – notation of the measured, input, and calculated parameters1
Measured parameters
PO2Oxygen partial pressure
PCO2Carbon dioxide partial pressure
pH Negative logarithm of the hydrogen ion activity
Na+Sodium concentration
K+Potassium concentration
Cl–Chloride concentration
Ca2+ Calcium concentration
Hct Hematocrit
tHb Total hemoglobin concentration
SO2Functional oxygen saturation
Baro Air pressure
Calculated parameters
H+Hydrogen ion concentration
cHCO3–Bicarbonate concentration in plasma
ctCO2(P) Total CO2concentration in plasma
ctCO2(B) Total carbon dioxide concentration in blood
BE Base deviation of blood
BEact Base deviation of blood at current oxygen saturation
BEecf Base deviation of the extracellular fluid
BB Buffer bases
ctO2Total oxygen concentration
pHst Standard pH value
cHCO3–st Standard bicarbonate concentration in plasma
PAO2Alveolar oxygen partial pressure
RI Respiratory index
nCa2+ Standardized ionized calcium (pH = 7.4)
Qs/Qt Shunt—quotient between both oxygen concentration differences
Qt Difference of oxygen concentration between alveolar and mixed venous blood
P50 (c) Oxygen partial pressure at 50% oxygen saturation calculated with SO2as meas-
urement value
1. Details and calculation, see Reference Manual

1 Introduction
1-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
SO2(c) Functional oxygen saturation calculated with P50 as input value
AaDO2Alveolar-arterial oxygen partial pressure
a/AO2Alveolar-arterial oxygen partial pressure ratio
avDO2Arterial-venous oxygen level difference
AG Anion gap
MCHC Middle corpuscular hemoglobin concentration
Osm Osmolality
OER Oxygen extraction ratio
Hct(c) Hct calculated from tHb
P/F index PaO2/FIO2ratio
Calculated parameters at the patient's temperature
PAO2tAlveolar oxygen partial pressure at patient's temperature
RItRespiratory index at patient's temperature
AaDO2tAlveolar-arterial oxygen partial pressure at patient's temperature
a/AO2tAlveolar-arterial oxygen partial pressure ratio at patient's temperature
pHtpH at patient's temperature
PCO2tPCO2at patient's temperature
PO2tPO2at patient's temperature
H+t Hydrogen concentration at patient's temperature
Input parameters
P50 Oxygen partial pressure at 50% oxygen saturation
RI Gas exchange quotient
FIO2Proportion of inspiratory oxygen
tHb Total hemoglobine
Temperature Patient temperature
Additional
Operator ID Sample type Blood type
Specimen ID Puncture site ALLEN test
A/F (adult/fetal) Pat ID Last name
First name Middle initials Date of birth
Gender Pract. Pat ID Height
Weigh t

1 Introduction
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002 1-11
Input parameters—patient information
Input values—measurement information
Insurance code Suffix Title
Maiden name Color of skin Address
Phone no. Diagnosis Medication
Diet Admission date Admission time
Discharge date Discharge time Admission status
Location Diagnose code Relig. denom.
Marital status Isolation status Patient language
Hospital service (KH ser-
vice)
Hospital institute Dosage cat.
Remark
Physisian Remark Acceptor
Date drawn Time drawn Place drawn
Danger code Clinic info Container
24 hr. urine Ventilation mode VT
MV PIP Ti
Te SRATE ARATE
PEEP MAP Flow rate

1 Introduction
1-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
Buttons
return to the highest level of the operating mode "Analyzer"
operating mode "Analyzer"
operating mode "Setup"
operating mode "Database"
additional functions
move one line up / down
page to the left / right, additional selection possibilities
select the marked entry
move one level up / back
activate / deactivate
confirm
cancel
go to additional views
print
add
remove
password
data input
details
start