Roche Omni C Reference manual

POINT OF CARE TESTING

Roche OMNI C

Reference Manual

Roche Diagnostics GmbH D-68298 Mannheim / Germany

www.roche.com

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 occur in this document. Subject to change without notice.

REF/No. 03261018001

Rev. 5.0, Juli 2003

First edition: October 2001

– Important information! – Always follow! –

This Reference Manual contains 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 machine.

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 only to be performed 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 stipu-

lated 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 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 –

1 Introduction

2 Specifications

3 Operating modes

4 Performance data

5 Trouble shooting

6 Interfaces

7 Theoretical foundations

8 Appendix

9 Index

1 Introduction

1.1 General notes ................................................................................................................... 1-1

1.1.1 General operating instructions.................................................................................................................1-1

1.1.2 Symbols.............................................................................................................................................................1-1

1.2 Safety instructions for specific dangers .................................................................... 1-2

1.2.1 Disposal of waste water, bottles, electrodes, and the instrument ..............................................1-2

1.2.2 Decontamination ...........................................................................................................................................1-2

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 1-I

1 Introduction

1-II

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

1 Introduction

1.1 General notes

1.1.1 General operating instructions

The Roche OMNI C should be enabled at all times!

Always perform shutdown procedures when the instrument will remain switched off for a longer period of time (longer than 24 hours). For additional information, please see the Instructions for Use, chapter 1 "Introduction", section "Shutdown").

Avoid leakage of fluids inside the analyzer.

Complete at least one quality control test every day (please see the Instructions for Use, chapter 5 , "Quality control", for more information) in order to quickly recognize error functions in the Roche OMNI C.

1.1.2 Symbols

1 Introduction

Reference manual

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."

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 1-1

1 Introduction

1.2 Safety instructions for specific dangers

1.2.1 Disposal of waste water, bottles, electrodes, and the instrument

Dispose of the waste container in accordance with local regulations for hazardous waste.

1.2.2 Decontamination

After use, components of the Roche OMNI C, including tubing, waste container, filling port, etc., contain biological fluids and represent therefore a possible infectious risk. Handle these components with care and avoid contact with skin.

Always wear gloves!

The purpose of this procedure is to minimize risk when replacing 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.

For more detailed information about decontamination, see the chapter "Maintenance" in the Instructions for Use.

1-2

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

2 System description and functionality

2.1 Screen ............................................................................................................................... 2-1

2.1.1 Screen arrangement.....................................................................................................................................2-1

2.1.2 Header line.......................................................................................................................................................2-2

2.1.3 Parallel operating modes............................................................................................................................2-3

2.1.4 Status line.........................................................................................................................................................2-4

2.2 Printer ................................................................................................................................ 2-4

2.3 Measuring chamber ....................................................................................................... 2-5

2.3.1 Electrodes.........................................................................................................................................................2-5

2.3.2 tHb/SO2 module.............................................................................................................................................2-6

2.4 Sample port module ....................................................................................................... 2-6

2.5 Pump .................................................................................................................................. 2-7

2.6 Bottle compartment ........................................................................................................ 2-8

2.6.1 Bottle compartment cover..........................................................................................................................2-8

2.7 Reverse side ..................................................................................................................... 2-8

2.8 Instrument cover ............................................................................................................. 2-9

2.9 Tubing system .................................................................................................................. 2-9

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 2-I

2 System description and functionality

2-II

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

2System description

screen

flap

2 System description

printer cover

contrast setting

instrument cover

bottle compartment cover

Fig. 1

2.1 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.

2.1.1 Screen arrangement

The Roche OMNI C screen is divided into three main areas:

reverse side

power pack / mains switch

unlocking knob for the AutoQC module

header line

operating mode area

status line

Fig. 2

This screen division applies to all areas of the Roche OMNI C software. The header and status lines are always available in the same division, the operating mode area depicts the status of the currently active operating mode and serves the interaction of the operating modes with the user.

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 2-1

2 System description

2.1.2 Header line

The header line contains the following elements:

operating mode selection button

general information window

Fig. 3

The operating mode selection button enables switching between the individual operating modes: Analyzer, Database, and Setup.

Pressing one of these buttons initiates a switch to the desired operating mode.

The menu times out after 5 seconds. In other words, when the user does not take any action, the menu disappears automatically after this length of time. Pressing the operating mode selection button again while the menu is visible closes the menu. Upon selection of an operating mode, the display switches to the corresponding side of the screen.

info button

button for "More functions"

The info button activates the Info operating mode. The Info operating mode has a special status because it is virtually superimposed on top of the other operating modes. The Info operating mode contains information on everything that could be associated with the instrument, specifically all status information (fill levels, electrodes, log entries), user information, and on-line help. Upon exit, the Info operating mode terminates completely.

Cancel

Fig. 4

2-2

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

2 System description

The button calls up a window with which the following functions may be activated:

Fig. 5

The keys are used for navigation through various operating modes or to functions in the current view. The "Cancel" button or a timeout closes the window without action.

The currently active operating mode uses the general information window to display navigation notes and/or detailed information about the displayed window.

2.1.3 Parallel operating modes

Analyzer

Database

Setup

Information, Help

Fig. 6

For more detailed information about the operating modes, please see the respective chapters in this Reference Manual or in the Instructions for Use.

More functions

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 2-3

2 System description

2.1.4 Status line

The status line permanently displays information about the Analyzer operating mode. The following information is displayed :

AutoQC logo (option available)

Fig. 7

Logo background: green: activated and ready

Logo background: green: connected

2.2 Printer

remote control logo

actual analyzer status current time

red: activated, not ready gray: not installed

gray: not connected

time and type of the next action that will interrupt the "Ready" status

Low-noise 2" thermal printer with integrated paper cutter.

Fig. 8

TIP: The printer paper is heat sensitive on one side only.

Please be certain that you insert the thermal paper correctly! Observe the instructions on the label on the inside of the printer cover.

2-4

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

2.3 Measuring chamber

The measuring chamber consists of the following components

• Electrical ground contact: grounds electrode amplifier's electrical currents.

• tHb/SO

• Val ve V 3, V5 : these valves serve to control the transport of fluid.

• Sample sensors SS1, SS2: these two sensors are located under the black sample sensor

covering plate. They detect the operating fluids and the sample.

• Tubi ng

• Measuring chamber trough: this is held at 37 °C. The electrodes are pushed through the

spring contacts against the retainers into the socket.

• Measuring chamber cover: it is held at 37 °C, contains the electrode window and the

switching magnet for the measuring chamber cover sensor.

• Contact bank: the contact bank contains the replaceable spring contacts for the elec-

trodes and the cover sensor. The electrode amplifiers are located behind the contact bank. A colour-coded strip is located above the contact bank and is used to identify the electrodes.

• Left retainer: serves to secure the electrodes as well as the tubes used with the reference

electrode.

• Locking lever: movable part of the left retainer.

module: see section 2.3.2!

2 System description

2.3.1 Electrodes

The correct positions of the various electrodes are easy to determine by the colours on their contact caps and/or by their labelling (see "Contact bank").

contact bank

Fig. 9

Colours of the electrode contact caps:

MCon pH MCon K

Ref

Na+Cl

contact cap

tHb / SO

PCO

TCon

Fig. 10

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 2-5

2 System description

2.3.2 tHb/SO2 module

The tHb/SO2 module is an optical sensor module for determining the levels of total hemoglobin (tHb) and oxygen saturation (SO

Fig. 11

The complete module is sealed and calibrated at the factory ("Factory setting") and may be exchanged only as a complete unit.

) in whole blood.

Never open the module!

2.4 Sample port module

The sample port module consists of the flap, the fill port holder (including fill port), the needle and the sample drip tray.

Flap

When opening the flap, notice two definitive locking positions:

• Flap position 1 (half opened) – syringe mode—for syringes and ampoules

2-6

Fig. 12

syringe

ampoule

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

2 System description

• Flap position 2 (completely opened) – Capillary mode—for capillaries and

Roche MICROSAMPLERS

Fig. 13

Needle, fill port holder with fill port and sample drip tray

suction tube fill port holder and fill port sample drip tray

Fig. 14

2.5 Pump

The peristaltic pump transports the sample and the operating fluids inside the instrument.

pump open

Fig. 15

tension lever

pump head

linear clamp

pump closed

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 2-7

2 System description

2.6 Bottle compartment

Docking mechanism

C3 fluid pack

C2 calibration solution 2

W waste container

Fig. 16

C1 calibration solution 1

2.6.1 Bottle compartment cover

A microswitch detects the status of the cover (open / closed).

The following image appears when the cover is opened (bottle exchange):

Fig. 17

2.7 Reverse side

See Instructions for Use, chapter 1 "Introduction"!

2-8

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

2.8 Power rating1- power supply

2 System description

Comments /

operating

conditions

Test No.

VoltageVFrequencyHzCurrentAPower in WPower in

1 90 50 2.01 145 174 warm-up

2 100 50 1.78 145 175 warm-up

3 240 50 0.78 133 188 warm-up

4 264 50 0.72 137 191 warm-up

5 90 60 2.18 148 196 warm-up

6 100 60 1.95 142 194 warm-up

7 120 60 1.67 138 200 warm-up

8 132 60 1.54 139 203 warm-up

9 240 60 0.97 133 233 warm-up

10 264 60 0.89 131 235 warm-up

11 240 50 0.29 44 70 Standby / normal

operating conditi-

ons

2.9 Instrument cover

The instrument cover provides mechanical protection for the measuring chamber, pump and valves. The cover is removable, but must remain closed while the unit is in operation.

Taken from the report of VDE: Testing and Certification Institute

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 2-9

2 System description

2.10 Tubing system

Peristaltic Pump

Air

V6 V7

Ref MConMCon

FMS

Waste Solution C1

Measuring Chamber

Na Cl pH Ca K

MCMMCCMCO

Air

O2 Zero Point Solution

C2C1

Conditioning Solution

Solution C2

Fig. 18

V1 ........ C1/C2 mixing valve

V2 ........ Air mixing valve

V3 ........ MC wash valve

V4 ........ MC bypass valve

V5 ........ Wash needle

V6 ........ MC out

V7 ........ Conditioner

V8 ........ Reference solution

V9 ........ Ventilation

V10 ...... Cleaning solution

V11 ...... Zero point solution

V14 ...... Bypass

Cleaning Solution

Reference Solution

O2 CO2

SS2

TCon

tHb/sO2

MCI

SS1

V11

Air

V10 V8

Needle

V14

V13

V12

AutoQC

V17

2-10

SS1, SS2....... Sample sensors

If the AutoQC module has been installed:

V12 ...... AQC valve

V13 ...... AQC wash valve

V17 ...... AQC wash valve II

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

3 Operating modes

3.1 Analyzer ............................................................................................................................ 3-1

3.1.1 "Ready" screen...............................................................................................................................................3-1

Parameter – depiction and buttons ................................................................. 3-1

Mandatory input ............................................................................................ 3-2

Password ........................................................................................................ 3-2

3.1.2 System ...............................................................................................................................................................3-3

Wash and clean .............................................................................................. 3-4

Tools .............................................................................................................. 3-6

Test .............................................................................................................. 3-13

Calibrations ................................................................................................. 3-26

3.1.3 Quick access ................................................................................................................................................ 3-26

3.1.4 QC measurement........................................................................................................................................ 3-26

3.2 Setup ................................................................................................................................ 3-27

3.2.1 Parameter ...................................................................................................................................................... 3-27

Miscellaneous settings .................................................................................. 3-28

Reference / critical ranges ............................................................................. 3-31

Correlations ................................................................................................. 3-32

3.2.2 Times & intervals ........................................................................................................................................ 3-33

Date and time ............................................................................................... 3-33

Calibration intervals ..................................................................................... 3-34

QC times ...................................................................................................... 3-34

Economy mode ............................................................................................. 3-34

Timeouts ...................................................................................................... 3-38

3.2.3 QC material................................................................................................................................................... 3-39

Set ranges ..................................................................................................... 3-39

AutoQC mat setup ........................................................................................ 3-39

3.2.4 Interfaces....................................................................................................................................................... 3-40

Network ....................................................................................................... 3-40

ASTM communication .................................................................................. 3-42

COM 1 ......................................................................................................... 3-42

COM 2 ......................................................................................................... 3-44

3.2.5 Displays & reports ...................................................................................................................................... 3-45

Measuring data ............................................................................................. 3-46

Parameter: display ranges ............................................................................. 3-54

QC ............................................................................................................... 3-54

Calibration ................................................................................................... 3-54

Patient database ........................................................................................... 3-54

Instrument data ............................................................................................ 3-55

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 3-I

3 Operating modes

3.2.6 Instrument ..................................................................................................................................................... 3-56

Language ...................................................................................................... 3-57

Roche info .................................................................................................... 3-58

Brightness level ............................................................................................. 3-59

Speaker ......................................................................................................... 3-59

Automatic patient ID .................................................................................... 3-60

Other units ................................................................................................... 3-60

Clinic info .................................................................................................... 3-61

Cleaning counter .......................................................................................... 3-61

AutoQC ........................................................................................................ 3-62

Ext. patient query ......................................................................................... 3-62

3.2.7 Password........................................................................................................................................................ 3-63

Security level ................................................................................................ 3-63

User management ......................................................................................... 3-63

Group administration ................................................................................... 3-64

3.2.8 Service area (password protected)...................................................................................................... 3-64

3.3 Database ......................................................................................................................... 3-65

3.3.1 Patient data................................................................................................................................................... 3-65

3.3.2 Measuring data ........................................................................................................................................... 3-66

3.3.3 Calibration data ........................................................................................................................................... 3-67

3.3.4 QC data .......................................................................................................................................................... 3-67

3.3.5 Instrument data ........................................................................................................................................... 3-68

3.3.6 Data export ................................................................................................................................................... 3-69

3.3.7 Delete data....................................................................................................................................................3-70

3-II

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

3 Operating modes

The Roche OMNI C is a combined bloodgas, electrolyte, and tHb/SO2 analyzer. It is possible to complete database procedures or to make adjustments simultaneously during measurement or calibration.

The individual, mutually independent operating modes are defined as follows:

a) Analyzer: measuring, QC, system, calibration, quick access b) Setup: instrument settings c) Database: contains data on patients, measuring, calibration, QC, and the instrument d) Info: Roche info, version numbers, fill levels, help, sensor status

3.1 Analyzer

The Analyzer operating mode has a special status among the operating modes.

3.1.1 "Ready" screen

3 Operating modes

The Ready screen is the central starting point for all operations.

Fig. 1

Parameter – depiction and buttons

For a description of the parameter depiction and buttons, please see Instructions for Use, chapter 1, "Introduction."

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 3-1

3 Operating modes

Mandatory input

Furthermore, the "Ready" screen can be modified by the activation of a "Mandatory input" field. If this function is activated in the "Setup" mode, a measurement can be started only when the entry has been completed. In the following example, the access code has been defined as a mandatory entry.

Fig. 2

Password

If the measurement is equipped with password protection, the "Ready" screen is covered by the password window but the parameter section remains visible (parameter information).

Fig. 3

3-2

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

3.1.2 System

The system section can be reached directly and only from the "Ready" screen.

This occurs by pressing the button.

This button calls up a window with which the following functions may be activated:

Fig. 4

3 Operating modes

more functions

pressing this button or a defined timeout closes the window without action

The following main menus are available:

Fig. 5

highest level of the Analyzer mode

select / deactivate

move one line up

move one line down

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 3-3

3 Operating modes

Wash and clean

System

Wash & Clean

Clean screen

Decont. sample

port module

Decontaminate

all tubes

Automatic

routines

Wash sample

path

Wash AutoQC

Internal cleaning

of sample path

Fig. 6

Clean screen

Upon entry into this function, the screen clears (white) and the touch screen deactivates for 30 seconds. A counter on the screen indicates the remaining number of seconds. After expiration of the 30 seconds, the next highest level menu appears again. Please see chapter "Maintenance" in the Instructions for Use for instructions on this cleaning procedure.

3-4

Decontaminate sample port module

This function assists in the decontamination of the sample port module, which consists of flap, needle, filling port holder, filling port, and wash plate.

Please see chapter "Maintenance" in the Instructions for Use for instructions on this cleaning procedure.

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

3 Operating modes

Decontaminate all tubes

Follow the instructions on the screen. Confirm every step with ! The shutdown kit gives instructions on decontaminating all tubing.

For a description, please see Instructions for Use, chapter 6, "Maintenance", section "Decontamination – Tubing paths."

Automatic routines

Wash sample path

This function washes out the sample path. It is not possible to interrupt this routine.

Wash AutoQC (option)

This function washes the optional AutoQC module if it is installed. It is possible to interrupt this sequence.

Internal cleaning of sample path

This function cleans the sample path. It is not possible to interrupt this sequence.

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003 3-5

3 Operating modes

Tools

System

Tools

Fluid actions

Tubing

exchange

Software

communication

Manual

economy mode

Software

shutdown

Shutdown

Installation

Conditioning

cycle

Replace PP

tubing

Software update

Auto

preparation

routines

Fill reference

electrode

Prepare

Calibration

Solution C1

Prepare

Calibration

Solution C2

Prepare

conditioning

solution

Prepare O2 zero

solutiom

Prepare

cleaning

solution

3-6

Export log data

Maintenance

PCMCIA-card

Fig. 7

Reference Manual, Roche OMNI C, Rev. 5.0, Juli 2003

+ 162 hidden pages