Omni C Analyzer Instructions for Use Rev 4.0 Dec 2002

– 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 requirements. 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 composition 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 stipulated by EN 61010-1: 1993 / IEC 1010-1 for electrical measurement, control, IVD, and laboratory 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 connection 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 –

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

1 Introduction

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

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

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1 Introduction

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

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Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

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, P O 2 , P CO 2 ) / ISE (Na + , K + , Cl – , Ca 2+ ) and tHb/ S O 2 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.

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1-1

1 Introduction

1.1

General notes

1.1.1 Application area The instrument is designed to measure BG / ISE / tHb/SO 2 in 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 biological 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.

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Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

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)

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

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1 Introduction

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:

1-4

All sections / text locations marked with "TIP" describe safe procedures that are intended to provide the user with additional "Help."

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

1.2

Measurement and calibration procedure

1.2.1 Measurement procedure Use the following procedures to calculate the various measurement variables: PO 2 : Use of the Clark measurement principle: measurement of current generated by the reduction of oxygen PCO 2 : Use of the Severinghouse principle: potentiometric measurement of the pH change in the electrode caused by CO 2 . pH-, Na + -, K + -, Ca 2+ - 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 chloride electrode in the Roche OMNI C. tHb /SO 2 : 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 SO 2 are 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 monitoring 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 clinical-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 regulations, after each electrode exchange and after the startup of the instrument (for detailed information see chapter 5 "Quality Control").

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1-5

1 Introduction

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 specific 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, "Maintenance."

1.5

Handling solutions Store the OMNI C solutions according to the specified packaging requirements. The solutions 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!

1-6

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

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 PCO 2 electrode Insert the electrode into the measuring chamber within 5 minutes of opening the ALUPE packaging. A special protective gas atmosphere designed to condition the PCO 2 electrode during storage is found inside the ALU-PE packaging. This gas atmosphere ensures immediate potential stability during insertion of the electrode 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 printer cover

screen contrast setting

Pump

flap

reverse side measurement chamber with electrodes and tHb/SO 2 module power pack / mains switch unlocking knob for the AutoQC module

bottle compartment cover

Fig. 2

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

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1 Introduction

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"). operating mode selection button

additional functions

parameter status and selection

status line 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: Parameter activated and ready

Parameter not ready (not calibrated)*

Parameter temporarily deactivated (but calibrated)

Parameter not ready (due to QC lock)

Parameter activated with QC warning

Parameter not ready due to remote lock

Parameter temporarily deactivated with QC warning

Parameter permanently deactivated (under "Setup")

* Pressing the parameter button produces a status report (see chapter 7, "Trouble shooting", section "Electrode status").

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Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

Parameter – notation of the measured, input, and calculated parameters 1 Measured parameters PO2

Oxygen partial pressure

P CO 2

Carbon dioxide partial pressure

pH

Negative logarithm of the hydrogen ion activity

Na K

+

Sodium concentration

+

Cl

Potassium concentration

–

Chloride concentration

2+

Calcium concentration

Ca

Hct

Hematocrit

tHb

Total hemoglobin concentration

SO2

Functional oxygen saturation

Baro

Air pressure

Calculated parameters H+

Hydrogen ion concentration

cHCO 3

–

Bicarbonate concentration in plasma

ctCO 2 (P)

Total CO 2 concentration in plasma

ctCO 2 (B)

Total carbon dioxide concentration in blood

BE

Base deviation of blood

BE act

Base deviation of blood at current oxygen saturation

BE ecf

Base deviation of the extracellular fluid

BB

Buffer bases

ctO 2

Total oxygen concentration

pH st

Standard pH value –

cHCO 3 st

Standard bicarbonate concentration in plasma

P AO 2

Alveolar oxygen partial pressure

RI

Respiratory index

nCa

2+

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

P 50 (c)

Oxygen partial pressure at 50% oxygen saturation calculated with SO 2 as measurement value

1. Details and calculation, see Reference Manual

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

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1 Introduction

SO 2 (c)

Functional oxygen saturation calculated with P 50 as input value

AaDO 2

Alveolar-arterial oxygen partial pressure

a/AO 2

Alveolar-arterial oxygen partial pressure ratio

avDO 2

Arterial-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

PaO 2 /FIO 2 ratio

Calculated parameters at the patient's temperature P AO 2 t

RI

Alveolar oxygen partial pressure at patient's temperature

t

Respiratory index at patient's temperature

AaDO 2 a/AO 2 pH

t

t

PO 2

Alveolar-arterial oxygen partial pressure at patient's temperature Alveolar-arterial oxygen partial pressure ratio at patient's temperature pH at patient's temperature

PCO 2 H

t

t

t

+t

PCO 2 at patient's temperature PO 2 at patient's temperature Hydrogen concentration at patient's temperature

Input parameters P 50

Oxygen partial pressure at 50% oxygen saturation

RI

Gas exchange quotient

F IO 2

Proportion 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

Weight

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Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

Input parameters-patient 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 service)

Hospital institute

Dosage cat.

Remark

Input values-measurement information 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

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

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1 Introduction

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

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Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

1 Introduction

1.7.3 Printer The low-noise 2" thermal printer with integrated paper cutter for roll paper is located underneath the printer cover.

1.7.4 Measurement chamber The measurement chamber with the electrodes and the tHb/SO 2 module are located underneath the instrument cover. The electrodes are flow-through electrodes with a visible sample channel. The tHb / SO 2 -module is an optical sensor module for determining the levels of total hemoglobin (tHb) and oxygen saturation (SO 2 ) in whole blood.

1.7.5 Pump A peristaltic pump transports the sample and the operating fluids inside the instrument.

1.7.6 Flap When opening the flap, notice two definitive locking positions: • •

Flap position 1 (half opened) – Syringe mode-for syringes and ampoules Flap position 2 (completely opened) – Capillary mode-for capillaries and microsamplers

1.7.7 Bottle compartment The calibration solutions and the waste container are located behind the bottle compartment cover.

1.7.8 Power supply This unit contains the mains power switch and the mains power connector. Position of the mains switch

Off

On

Fig. 4

Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002

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1 Introduction

1.7.9 Reverse side Interface Only data processing units manufactured according to the standards IEC 950 (UL1950) may be attached to the interface connections!

COM 1

COM 2

network connection

barcode scanner Fig. 5 • • • •

COM 1* COM 2* Barcode Network

*TIP:

RS 232 interface RS 232 interface PS/2 DIN-6p jack 10 BaseT Ethernet (RJ45)

Always use a filter adapter when using the serial interface. Please order this part from your customer service representative!

COM 1 This interface can be assigned to a ticket printer and Host FMT. For an exact description of the assignment, see the section "Settings > Interfaces > COM 1" in chapter 3, "Operating modes," of the Reference Manual.

COM 2 This interface can be assigned as serial interface to ASTM. For an exact description of the assignment, see the section "Settings > Interfaces > COM 2" in chapter 3, "Operating modes," of the Reference Manual.

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Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002