Medica EasyStat Manuel utilisateur

\EDIC@ EasyStat

Operator’s

Manual

ANALYZE QC

FLOWCHA RT 2

FLOWCHA RT 3

If all channels failed

If incorrect barcode scanned

1 *

2 *

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

HOME MENU

1 ANALYZE SAMPLE

2 ANALYZE QC

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

HOME MENU

1 STANDBY

2 REPLACE COMPONENTS

3 DIAGNOSTICS

4 STORED INFORMATION

5 SETUP MENU

6 ADJUST DISPLAY

SECOND MENU

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVEL 1

5 Hct LEVEL 2

6 PROFICIENCY

LIFT SAMPLER TO

ANALYZE

pH PCO2

PO2

Hct Na +

+Ca ++

CALIBRATE

CALIBRATING . . .

DAILY CLEANER

LIFT SAMPLER TO

USE CLEANER

1 REAGENT MODULE

2 ELECTRODES

3 PUMP TUBING

4 SENSOR MODULE/SAMPLER

5 VALVE MODULE

6 SWITCH TO Ca

/ Cl-

REPLACE COMPONENTS

1 TEST COMPONENTS

2 TEST FLUIDICS

3 SENSOR STATUS

4 PRIME FLUIDS

5 PRINT mV’s

DIAGNOSTICS

1 PATIENT RESULTS

2 QC RESULTS

3 REFERENCE LIMITS

4 CAL / SAMPLE # DATA

5 REAGENT MODULE

6 PRINTOUTS

STORED INFORMATION

PAT. TEMP 37.0

THb 14.5 g/dL

FIO2 21%

TIME DRAWN 00.00

ENTER PATIENT DATA 1/2

CONFIRM ?

1 BRIGHTNESS

2 BRIGHTNESS

3 REVERSE

ADJUST DISPLAY

QC HcT LEVEL 1

LOT # XXXXXX

LIFT SAMPLER TO

ANALYZE CONTROL

MANUAL STANDBY

CONFIRM ?

SECURITY CODE

* * * *

CONFIRM ?

QC LEVEL 1

LOT # XXXXXX

LIFT SAMPLER TO

ANALYZE CONTROL

QC LEVEL 1

LOT # XXXXXX

LIFT SAMPLER TO

ANALYZE CONTROL

1 USER OPTIONS

2 CONFIGURATION

3 PRINTER OPTIONS

4 SET REFERENCE LIMITS

5 PATIENT INFORMATION

6 DELETE DATA

SETUP MENU

1 PUMP

2 VALVE

3 SAMPLER SWITCHES

4 DOOR SWITCH

5 REAGENT READER

TEST COMPONENTS

1 REAGENT FLOW

2 SAMPLE FLOW

3 BUBBLE DETECTOR CAL

4 PUMP CAL

TEST FLUIDICS

1 ELECTRODE mV’s

2 BAROMETRIC PRESSURE

3 TEMPERATURES

SENSOR STATUS

pH 7.203

PCO

232.5 mmHg

PO2118 mmol/L

+ 140.9 mmol/L

K+ 4.50 mmol/L

++ 2.33 mmol/L

QC LEVEL 1

STORE RESULTS ?

SAMPLE TYPE ARTERIAL

SAMPLE SITE RADIAL

OPERATOR ID?

ENTER PATIENT DATA 2/2

CONFIRM ?

Cl-

MODE ?

QC HcT LEVEL 1

Hct 55 %

STORE RESULTS ?

1 CALIBRANT A mV’s

2 CALIBRANT B mV’s

3 CALIBRANT C mV’s

ELECTRODE mV’s

pH 7.203

PCO

232.5 mmHg

PO2118 mmol/L

Hct 45%

+ 140.1 mmol/L

K+ 4.02 mmol/L

++ 2.33 mmol/L

ANALYSIS RESULTS #001

PATIENT RESULTS

WILL BE LOST

CONFIRM ?

pH 23.99

PCO

234.00

PO299.99

Hct 87.34

+ 10.78

K+ 41.00

++ 10.00

SLOPES

pH XX.X

PCO

2XX.X

PO2XX.X

+XX.X

K+XX.X

++ XX.X

ELECTRODE mV’s

CALIBRANT A mV’s

THb XXX g/dL

pH (T) XXX

PCO

2(T) XXX mmHg

PO2

(T) XXX mmHg

TCO

2XXX mmol/L

HCO3XXX mmol/L

BEb

XXX mmol/L

CALCULATED VALUES 1/3

BEecf XXX mmol/L

SBC XXX mmol/L

%sO 2c XXX

ctO

2XXX mL/L

CALCULATED VALUES 2/3

CALCULATED VALUES 3/3

Hct XXX.X

ELECTRODE mV’s

CALIBRANT A mV’s

A-aDO

2XXX mmHG

RI XXX

++ (7.4)

XXX mmol/L

Flow Charts

Note: Ca++ will be replaced by Cl-in Cl-mode.

Ca++ (7.4) will be replaced by Anion Gap in Cl-mode

1 STANDBY

2 REPLACE COMPONENTS

3 DIAGNOSTICS

4 STORED INFORMATION

5 SETUP MENU

6 ADJUST DISPLAY

SECOND MENU

SECURITY CODE

* * * *

CONFIRM ?

1 USER OPTIONS

2 CONFIGURATION

3 PRINTER OPTIONS

4 SET REFERENCE LIMITS

5 PATIENT INFORMATION

6 DELETE DATA

SETUP MENU

1 ENGLISH

LANGUAGE

1 SET PARAMETERS

2 APPLY CORRELATION

CORRELATION

1 DATE / TIME

2 LANGUAGE

3 CORRELATION

4 REPORTED PATIENT DATA

5 BAROMETRIC PRESSURE

6 SECURITY CODE

USER OPTIONS

DATE / TIME

DEC - 05 - 2001; 15:30

CONFIRM ?

1 PO

2 / PCO2

/ BP mmHg

2 Na

K+

/ Ca

mmol/L

3 Hct %

4 Hb

g/dL

5 BC CHECKSUM OFF

CONFIRM ?

CONFIGURATION 1/2

PRINTER OPTIONS

1 PRINTER ON

2 CALC’D VALUES ON

3 PRINTOUTS 1

1 QC

2 NORMAL

3 CRITICAL

4 AMR

SET REFERENCE LIMITS

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVEL 1

5 Hct LEVEL 2

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVELS

SET Rili-BAK LIMITS

SET QC REFERENCE LIMITS

1 ANALYTES

2 CALCULATED VALUES

REPORTED PATIENT DATA

1 CAL FREQUENCY 8 HRS

2 AUTO STANDBY OFF

3 TEMPERATURE C

4 Rili-BAK OFF

5 AMR OFF

CONFIRM ?

CONFIGURATION 2/2

CURRENT READING

XXX.X mmHg

CONFIRM ?

BAROMETRIC PRESSURE

pH X.XXX

X.XXX

PCO2

XXX.X

XXX.X mmHg

2 XXX

XXX mmHg

CONFIRM ?

SET REFERENCE LIMITS 1/2

QC LEVEL 1

LOT #XXXXXXX

SET REFERENCE LIMITS

QC Hct LEVEL 1

LOT #XXXXXXX

Hct XX

XX %

QC Hct LEVEL 2

LOT #XXXXXXX

Hct XX

XX %

CONFIRM ?

pH = X.XXXX + X.XXX

PCO

2 = X.XXX + X.X mmHg

PO2 = X.XXX + X mmHg

Hct = X.XXX + X %

CONFIRM ?

CORRELATION 1/2

SET PARAMETERS

SLOPE INTERCEPT

1 pH ON

2 PCO

2 ON

3 PO

2 ON

4 Hct ON

CONFIRM ?

REPORTED PATIENT DATA 1/2

ANALYTES

1 PATIENT RESULTS OFF

2 QC RESULTS OFF

CONFIRM ?

APPLY CORRELATION

1 THb ON

2 pH (T) ON

3 PCO

2(T) ON

4 PO

(T) ON

5 TCO

2 ON

CONFIRM ?

REPORTED PATIENT DATA 1/3

CALCULATED VALUES

+ XXX.X

XXX.X mmol/L

K+ X.XX X.XX mmol/L

++ X.XX X.XX mmol/L

CONFIRM ?

SET REFERENCE LIMITS 2/2

QC LEVEL 1

LOT #XXXXXXX

SET REFERENCE LIMITS 1/6

Rili-BAK LEVEL 1

LOT #XXXXXXX

SET REFERENCE LIMITS

Rili-BAK LEVEL 1

LOT #XXXXXXX

Hct

SET REFERENCE LIMITS

Rili-BAK LEVEL 2

LOT #XXXXXXX

Hct

TARGET X.XXX mmHg

DEVIATION X.X %

RILIBAK X.XXX

X.XXX mmHg

CONFIRM ?

TARGET X.XXX mmHg

DEVIATION X.X %

RILIBAK X.XXX

X.XXX mmHg

CONFIRM ?

SET REFERENCE LIMITS 2/6

Rili-BAK LEVEL 1

LOT #XXXXXXX

pCO2

1 Na

+ ON

2 K+ ON

3 Ca

++ ON

CONFIRM ?

REPORTED PATIENT DATA 2/2

ANALYTES

+ = X.XXX + X.X mmol/L

K+ = X.XXX + X.XX mmol/L

++ = X.XXX + X.XX mmol/L

CONFIRM ?

CORRELATION 2/2

SET PARAMETERS

SLOPE INTERCEPT

1 HCO3 ON

2 BEb ON

3 BEecf ON

4 SBC ON

5 %s0

CONFIRM ?

REPORTED PATIENT DATA 2/3

CALCULATED VALUES

1 ctO

2 ON

2 A-aDO

2 ON

3 RI ON

4 Ca

(7.4)

CONFIRM ?

REPORTED PATIENT DATA 3/3

CALCULATED VALUES

TARGET XX %

DEVIATION XX %

RILIBAK

XX %

CONFIRM ?

TARGET XX %

DEVIATION XX %

RILIBAK

XX %

CONFIRM ?

SET AMR LIMITS 1/2

1 PATIENT ID OFF

2 PATIENT TEMP OFF

3 Hb OFF

4 FI O

2 OFF

5 TIME DRAWN OFF

CONFIRM ?

PATIENT INFORMATION 1/2

1 ALL QC LEVEL 1

2 ALL QC LEVEL 2

3 ALL QC LEVEL 3

4 ALL QC Hct LEVEL 1

5 ALL QC Hct LEVEL 2

6 ALL PATIENT RESULTS

DELETE DATA

pH X.XXX

X.XXX

PCO

2 XXX.X

XXX.X mmHg

PO2 XXX

XXX mmHg

Hct XX

XX %

CONFIRM ?

SET AMR LIMITS 2/2

1 SAMPLE TYPE OFF

2 SAMPLE SITE OFF

3 OPERATOR ID OFF

CONFIRM ?

PATIENT INFORMATION 2/2

pH X.XXX

X.XXX

PCO

2 XXX.X

XXX.X mmHg

PO2 XXX

XXX mmHg

Hct XX

XX %

CONFIRM ?

SET REFERENCE LIMITS 1/2

NORMAL

ARTERIAL

pH X.XXX

X.XXX

PCO

2 XXX.X

XXX.X mmHg

PO2 XXX

XXX mmHg

Hct XX

XX %

CONFIRM ?

SET REFERENCE LIMITS 1/2

CRITICAL

ARTERIAL

XXX.X

XXX.X mmol/L

K+

X.XX

X.XX mmol/L

++ X.XX

X.XX mmol/L

CONFIRM ?

1 ARTERIAL

2 MIXED VENOUS

3 VENOUS

SET NORMAL LIMITS

1 ARTERIAL

2 MIXED VENOUS

3 VENOUS

SET CRITICAL LIMITS

XXX.X

XXX.X mmol/L

K+

X.XX

X.XX mmol/L

++ X.XX

X.XX mmol/L

CONFIRM ?

SET REFERENCE LIMITS 2/2

NORMAL

ARTERIAL

XXX.X

XXX.X mmol/L

K+

X.XX

X.XX mmol/L

++ X.XX

X.XX mmol/L

CONFIRM ?

SET REFERENCE LIMITS 2/2

CRITICAL

ARTERIAL

1 PATIENT RESULTS

2 QC RESULTS

3 REFERENCE LIMITS

4 CAL/SAMPLE # DATA

5 REAGENT MODULE

6 PRINTOUTS

STORED INFORMATION

1 LAST

2 ALL

3 ENTER ID#

PATIENT RESULTS

1 LAST CONTROL

2 PRINT QC STATS

3 PRINT QC RESULTS

4 PLOT QC CHARTS

5 FAILED QC

QC RESULTS

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVEL 1

5 Hct LEVEL 2

LAST CONTROL

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVEL 1

5 Hct LEVEL 2

6 ALL LEVELS

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVEL 1

5 Hct LEVEL 2

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVEL 1

5 Hct LEVEL 2

1 LEVEL 1

2 LEVEL 2

3 LEVEL 3

4 Hct LEVELS

1 QC

2 NORMAL

3 CRITICAL

4 AMR

PRINT QC STATS

PLOT QC CHARTS

1 pH

2 PCO

3 PO2

4 Hct

5 Na+

6 K+

7 Ca

8ALL CHARTS

1 ARTERIAL

2 MIXED VENOUS

3 VENOUS

NORMAL LIMITS

1 ARTERIAL

2 MIXED VENOUS

3 VENOUS

CRITICAL LIMITS

pH X.XXX

X.XXX

PCO

2XXX.X

XXX.X mmHg

PO2XXX

XXX mmHg

REFERENCE LIMITS 1/2

AMR

REFERENCE LIMITS 2/2

AMR

REMOVE FROM STATS ?

DEC-16 13:57 1/XX

REMOVE FROM STATS ?

DEC-16 13:57 1/XX

pH X.XXX

PCO

2XXX.X

PO2XXX

+ XXX.X

K+ X.XX

++ X.XX

CONFIRM ?

DEC-16 13:57 1/XX

pH X.XXX

PCO

2XXX.X

PO2XXX

+ XXX.X

K+ X.XX

++ X.XX

DEC-12 16:25 2/XX

pH X.XXX

PCO

2XXX.X

PO2XXX

+ XXX.X

K+ X.XX

++ X.XX

pH X.XXX

X.XXX

PCO

2XXX.X

XXX.X mmHg

PO2XXX

XXX mmHg

REFERENCE LIMITS 1/2

QC LEVEL 1

LOT # XXXXXXX

XXX.X

XXX.X mmol/L

K+

X.XX

X.XX mmol/L

X.XX

X.XX mmol/L

REFERENCE LIMITS 2/2

QC LEVEL 1

LOT # XXXXXXX

TARGET XX %

DEVIATION X.X %

RILIBAK

XX %

TARGET XX %

DEVIATION X.X %

RILIBAK

XX %

REFERENCE LIMITS 1/6

Rili-BAK LEVEL 1

LOT #XXXXXXX

TARGET X.XXX mmHg

DEVIATION X.XX %

RILIBAK X.XXX

X.XXX mmHg

TARGET X.XXX mmHg

DEVIATION X.XX %

RILIBAK X.XXX

X.XXX mmHg

REFERENCE LIMITS 2/6

Rili-BAK LEVEL 1

LOT #XXXXXXX

pCO2

REFERENCE LIMITS

Rili-BAK LEVEL 1

LOT #XXXXXXX

Hct

REFERENCE LIMITS

Rili-BAK LEVEL 2

LOT #XXXXXXX

Hct

REFERENCE LIMITS

Rili-BAK LIMITS

FAILED QC

QC REFERENCE LIMITS

Hct LEVEL 1

X.XX %

Hct LEVEL 2

X.XX %

+XXX.X

XXX.X mmol/L

K+X.XX

X.XX mmol/L

++ X.XX

X.XX mmol/L

Hct XX

XX %

REFERENCE LIMITS 1/2

NORMAL

ARTERIAL

pH X.XXX

X.XXX

PCO

2XXX.X

XXX.X mmHg

PO2XXX

XXX mmHg

Hct XX

XX %

pH X.XXX

X.XXX

PCO

2XXX.X

XXX.X mmHg

PO2XXX

XXX mmHg

Hct XX

XX %

REFERENCE LIMITS 1/2

CRITICAL

ARTERIAL

+XXX.X

XXX.X mmol/L

K+X.XX

X.XX mmol/L

++ X.XX

X.XX mmol/L

REFERENCE LIMITS 2/2

NORMAL

ARTERIAL

+XXX.X

XXX.X mmol/L

K+X.XX

X.XX mmol/L

++ X.XX

X.XXX mmol/L

REFERENCE LIMITS 2/2

CRITICAL

ARTERIAL

REFERENCE LIMITS

QC Hct LEVEL 1

LOT #XXXXXXX

Hct XX

XX %

QC Hct LEVEL 2

LOT #XXXXXXX

Hct XX

XX %

CONFIRM ?

1 USER OPTIONS

2 CONFIGURATION

3 PRINTER OPTIONS

4 PATIENT LIMITS

5 QC LIMITS

6 PATIENT INFORMATION

PRINTOUTS

1 SLOPES

2 mV’s

3 PUMP / BUBBLE DETECTOR

4 SAMPLE COUNTER

CAL / SAMPLE # DATA

1 STATUS

2 CONCENTRATIONS

REAGENT MODULE

pH 23.99 PASS

PCO

234.00 PASS

PO299.99 PASS

Hct 87.34 PASS

+ 10.78 PASS

K+ 41.00 PASS

++ 30.00 PASS

SLOPES

CAL A CAL B CAL C

pH XX.X XX.X XX.X

PCO

2XX.X XX.X XX.X

PO2XX.X XX.X XX.X

Hct XX.X XX.X XX.X

CAL / SAMPLE # DATA 1/2

mv’S

REAGENT MODULE

STATUS

S/N 0001-0200-03-001

INSTALLED DEC-05-01

UNIT S/N 0123456789

98 %, 30 DAYS

Cal pH PCO2

mmHg mmHg

A X.XXX XXX.X XXX

B X.XXX XXX.X XXX

C X.XXX XXX.X XXX

REAGENT MODULE 1/3

CONCENTRATIONS

Cal Hct Na

% nmol/L nmol/L

A XX XXX.X XX.X

B XX XXX.X XX.X

C XX XXX.X XX.X

REAGENT MODULE 2/3

CONCENTRATIONS

Cal Ca ++

nmol/L

A X.XXX

B X.XXX

C X.XXX

REAGENT MODULE 3/3

CONCENTRATIONS

CAL A CAL B CAL C

XX.X XX.X XX.X

K+

XX.X XX.X XX.X

CAL / SAMPLE # DATA 2/2

mv’S

Operator’s Manual

\EDIC@ EasyStat

Ref. 7415

003770-901R1, 2015-07

No part of this manual may be reproduced in any form without prior consent in writing from Medica Corporation.

The Medica EasyStat® analyzer is for In Vitro Diagnostic Use.

Medica Corporation, 5 Oak Park Drive

Bedford, MA 01730-1413 USA

Emergo Europe, Molenstraat 15

NL-2513 BH The Hague, The Netherlands

EasyStat® and EasyQC® are registered trademarks of Medica Corporation.

The information in this manual was correct at the time of printing. However, Medica Corporation continues to improve products and reserves

the right to change specifications, equipment, and maintenance procedures at any time without notice.

If the system is used in a manner differently than specified by Medica Corporation, performance of the equipment may be impaired. See all

Hazards, Precautions and Warnings.

Preface

This Operator’s Manual will assist you in using the EasyStat analyzer. Easy-to-follow instructions guide

you through analyzer setup and operation. Display messages and flow charts are combined with the

written instructions for quick reference.

Symbols used throughout the manual

EasyStat display messages

important information

conditions which may cause data loss or analyzer malfunction

biohazard warning

sampler positioning required by operator

access door must be closed for proper operation

syringe sample mode

capillary sample mode

compression plate positioning required by operator

DISPLAY TYPE

Contents

Preface

1 Understanding the EasyStat Analyzer

Intended Use.....................................................................................................................................5

Operational Hazards and Precautions ................................................................................................6

2 Analyzer Layout

Front View ........................................................................................................................................8

Rear View.........................................................................................................................................9

Keypad...........................................................................................................................................10

Display ...........................................................................................................................................11

Fluid Path Description ......................................................................................................................12

3 Analyzer Installation

Unpacking ......................................................................................................................................14

Location..........................................................................................................................................15

Power Up........................................................................................................................................16

Date/Time.......................................................................................................................................17

Components....................................................................................................................................18

4 Operating the Analyzer

Calibrate.........................................................................................................................................22

Analyze Sample..............................................................................................................................24

Analyze QC....................................................................................................................................32

Daily Cleaner..................................................................................................................................40

Second Menu..................................................................................................................................42

Standby..........................................................................................................................................43

Replace Components .......................................................................................................................44

Analyzer Surface Cleaning/Storage.................................................................................................64

Diagnostics .....................................................................................................................................65

Stored Information...........................................................................................................................74

Setup Menu.....................................................................................................................................82

Adjust Display.................................................................................................................................93

5 Sample Handling and Collection

Syringe Sample...............................................................................................................................94

Capillary Sample ............................................................................................................................95

Interfering Substances......................................................................................................................95

6 Principles of Operation/Theory

pH, Na+, K+, Ca++, and Cl-Electrodes ...........................................................................................96

PCO2 Electrode .......................................................................................................................... 100

PO2Electrode.............................................................................................................................. 100

Hct Sensor .................................................................................................................................. 101

Electrode Measurement/Diagrams................................................................................................. 102

Tonometered Reagents .................................................................................................................. 103

Calculations ................................................................................................................................ 104

7 Specifications

............................................................................................................................................ 110

8 EasyStat Setup Defaults

............................................................................................................................................ 114

9 Troubleshooting

Introduction.................................................................................................................................. 115

Electrodes .................................................................................................................................... 117

Flow ............................................................................................................................................ 125

Reagent Module ........................................................................................................................... 134

Sensor Module............................................................................................................................. 136

Valve Module............................................................................................................................... 139

Printer.......................................................................................................................................... 141

Hardware .................................................................................................................................... 142

Quality Control ............................................................................................................................ 142

Computer Connection

............................................................................................................................................ 143

11 Replacement Schedule

............................................................................................................................................ 145

Appendices

Appendix A: Warranty ................................................................................................................ 147

Appendix B: Understanding the Symbols ...................................................................................... 149

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