Omni C Analyzer Reference Manual

– 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 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 Operating modes 4 Performance data 5 Trouble shooting 6 Interfaces 7 Theoretical foundations 8 Appendix 9 Index

1 Introduction

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

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1 Introduction

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

1 Introduction

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 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

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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.

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

2 System description and functionality

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

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2 System description and functionality

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

2 System description

2

System description screen printer cover

contrast setting flap reverse side

instrument cover

power pack / mains switch unlocking knob for the AutoQC module

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: 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

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2 System description

2.1.2 Header line The header line contains the following elements: operating mode selection button

info button

general information window

button for "More functions"

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.

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

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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

More functions

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.

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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 1) (option available)

actual analyzer status

remote control logo 2)

current time

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

Fig. 7

1) Logo background: green: activated and ready

red: activated, not ready gray: not installed 2)

2.2

Logo background: green: connected gray: not connected

Printer 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.

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

2 System description

2.3

Measuring chamber The measuring chamber consists of the following components • • • • • • • •

• •

Electrical ground contact: grounds electrode amplifier's electrical currents. tHb/SO 2 module: see section 2.3.2! Valve V3, 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. Tubing 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 electrodes 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.

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 cap

contact bank

Fig. 9

Colours of the electrode contact caps:

tHb / SO2 Ref

MCon

Na+

Cl -

pH

MCon

Ca2+

K+

PO 2

PCO 2 TCon

Fig. 10

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

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2 System description

2.3.2 tHb/ SO 2 module 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.

Fig. 11

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

syringe

ampoule

Fig. 12

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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.

tension lever

pump head linear clamp

pump open

pump closed

Fig. 15

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

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2 System description

2.6

Bottle compartment Docking mechanism

C3 fluid pack

C2 calibration solution 2 W waste container

C1 calibration solution 1

Fig. 16

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"!

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

2 System description

2.8

2.9

Power rating 1 - power supply

Test No.

Voltage V

Frequency Hz

Current A

Power in W

Power in VA

Comments / operating conditions

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 conditions

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.

1

Taken from the report of VDE: Testing and Certification Institute

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

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2 System description

2.10 Tubing system

Peristaltic Pump Air

V6

V7

V5

Measuring Chamber Ref

MCon

MCon Na

Cl

pH

MCO MCC

Ca

K

MCM

O2

Needle

SS2 TCon

tHb/sO2

V3

SS1

CO2 MCI

Pa V4

V14 Air

FMS

V1

V2

V11

C3 W

Waste

C1

Solution C1

C2

Solution C2

V9

O2 Zero Point Solution Conditioning Solution Cleaning Solution Reference Solution

V13

Air

V12

Air V10

V8

AutoQC V17

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 SS1, SS2 ... Sample sensors If the AutoQC module has been installed: V12 ... AQC valve V13 ... AQC wash valve V17 ... AQC wash valve II

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