Medica EasyStat Operator's Manual

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Page 1

\EDIC@

Manual

EasyStat

Operator’s

Page 2

Flow Charts

HOME MENU

1 * 2 * 3 CALIBRAT E 4 DAILY CLEANER 5 SECOND MENU

HOME MENU

1 ANALYZE SAMPLE

2 ANALYZE QC 3 CALIBRAT E 4 DAILY CLEANER 5 SECOND MENU

LIFT SAMPLER TO

ANALYZE

pH PCO2 PO2

K+ Ca

Hct Na

ANALYZE QC

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVEL 1 5 Hct LEVEL 2 6 PROFICIENCY

CALIBRATE

CALIBRATING . . .

DAILY CLEANER

LIFT SAMPLER TO

USE CLEANER

SECOND MENU

1 STANDBY 2 REPLACE COMPONENTS 3 DIAGNOSTICS 4 STORED INFORMATION 5 SETUP MENU 6 ADJUST DISPLAY

ENTER PATIENT DATA 1/2

ID PAT. TEMP 37.0 THb 14.5 g/dL FIO

TIME DRAWN 00.00

21%

CONFIRM ?

QC LEVEL 1

LOT # XXXXXX

LIFT SAMPLER TO ANALYZE CONTROL

QC HcT LEVEL 1

LOT # XXXXXX

LIFT SAMPLER TO ANALYZE CONTROL

MANUAL STANDBY

CONFIRM ?

REPLACE COMPONENTS

1 REAGENT MODULE 2 ELECTRODES 3 PUMP TUBING 4 SENSOR MODULE/SAMPLER 5 VA LVE MODULE 6 SWITCH TO Ca

DIAGNOSTICS

1 TEST COMPONENTS 2 TEST FLUIDICS 3 SENSOR STATUS 4 PRIME FLUIDS 5 PRINT mV

/ Cl-

’s

ENTER PATIENT DATA 2/2

SAMPLE TYPE ARTERIAL SAMPLE SITE RADIAL OPERATOR ID?

CONFIRM ?

QC LEVEL 1

pH 7.203 PCO

32.5 mmHg

118 mmol/L

2 +

140.9 mmol/L

4.50 mmol/L

2.33 mmol/L

STORE RESULTS ?

QC HcT LEVEL 1

Hct 55 %

STORE RESULTS ?

If incorrect barcode scanned

If all channels failed

Cl- MODE ?

TEST COMPONENTS

1 PUMP 2 VA LVE 3 SAMPLER SWITCHES 4 DOOR SWITC H 5 REAGENT READER

ANALYSIS RESULTS #001

pH 7.203 PCO

32.5 mmHg

118 mmol/L

Hct 45%

140.1 mmol/L

4.02 mmol/L

2.33 mmol/L

SLOPES

pH 23.99

34.00

PCO

PO2 99.99 Hct 87.34

CONFIRM ?

10.78

41.00

10.00

K Ca

PATIENT RESULTS

WILL BE LOST

CALCULATED VALUES 1/3

THb XXX g/dL pH (T) XXX PCO

(T) XXX mmHg

TCO

XXX mmol/L

HCO

XXX mmol/L

BEb

CALCULATED VALUES 2/3

BEecf XXX mmol/L SBC XXX mmol/L %sO

c XXX

ctO

XXX mL/L

CALCULATED VALUES 3/3

A-aDO2 XXX mmHG RI XXX

(7.4) XXX mmol/L

QC LEVEL 1

LOT # XXXXXX

LIFT SAMPLER TO

ANALYZE CONTROL

STORED INFORMATION

1 PATIENT RESULT S 2 QC RESULT S 3 REFERENCE LIMITS 4 CAL / SAMPLE # DATA 5 REAGENT MODULE 6 PRINTOUTS

SECURITY CODE

* * * *

CONFIRM ?

ADJUST DISPLAY

1 BRIGHTNESS 2 BRIGHTNESS 3 REVERSE

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

TEST FLUIDICS

1 REAGENT FLOW 2 SAMPLE FLOW 3 BUBBLE DETECTOR CAL 4 PUMP CAL

SENSOR STATUS

1 ELECTRODE mV’s 2 BAROMETRIC PRESSURE 3 TEMPERATURES

FLOWCHA RT 3

SETUP MENU

1 USER OPTIONS 2 CONFIGURATION 3 PRINTER OPTIONS 4 SET REFERENCE LIMITS 5 PATIENT INFORMATION 6 DELETE DATA

ELECTRODE mV’s

1 CALIBRANT A mV 2 CALIBRANT B mV

3 CALIBRANT C mV

FLOWCHA RT 2

’s ’s ’s

ELECTRODE mV’s

CALIBRANT A mV’s

pH XX.X PCO

XX.X

ELECTRODE mV’s

CALIBRANT A mV’s

Hct XXX.X

XX.X

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SECOND MENU

1 STANDBY 2 REPLACE COMPONENTS 3 DIAGNOSTICS 4 STORED INFORMATION 5 SETUP MENU 6 ADJUST DISPLAY

SECURITY CODE

* * * *

CONFIRM ?

USER OPTIONS

1 DATE / TIME 2 LANGUAGE 3 CORRELATION 4 REPORTED PATIENT DATA 5 BAROMETRIC PRESSURE 6 SECURITY CODE

DATE / TIME

DEC - 05 - 2001; 15:30

CONFIRM ?

LANGUAGE

1 ENGLISH

SETUP MENU

1 USER OPTIONS 2 CONFIGURATION 3 PRINTER OPTIONS 4 SET REFERENCE LIMITS 5 PATIENT INFORMATION 6 DELETE DATA

CONFIGURATION 1/2

1 PO2 / PCO2 / BP mmHg

+ / K+

/ Ca

mmol/L

CONFIRM ?

g/dL

2 Na 3 Hct % 4 Hb 5 BC CHECKSUM OFF

PRINTER OPTIONS

1 PRINTER ON 2 CALC’D VALUES ON 3 PRINTO UTS 1

SET REFERENCE LIMITS

1 QC 2 NORMAL 3 CRITICAL 4 AMR

CORRELATION

1 SET PARAMETERS 2 APPLY CORRELATION

REPORTED PATIENT DATA

1 ANALYTES 2 CALCULATED VALUES

BAROMETRIC PRESSURE

CURRENT READING

XXX.X mmHg

CONFIRM ?

CONFIGURATION 2/2

1 CAL FREQUENCY 8 HRS 2 AUTO STANDBY OFF 3 TEMPERATURE C 4 Rili-BAK OFF 5 AMR OFF

CONFIRM ?

SET QC REFERENCE LIMITS

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVELS

SET Rili-BAK LIMITS

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVEL 1 5 Hct LEVEL 2

CORRELATION 1/2

SET PARAMETERS

SLOPE INTERCEPT

pH = X.XXXX + X.XXX

= X.XXX + X.X mmHg

PCO

= X.XXX + X mmHg

Hct = X.XXX + X %

CONFIRM ?

APPLY CORRELATION

1 PATIENT RESULTS OFF 2 QC RESULTS OFF

CONFIRM ?

REPORTED PATIENT DATA 1/2

ANALYTES

1 pH ON

2 PCO

3 PO

4 Hct ON

CONFIRM ?

REPORTED PATIENT DATA 1/3

CALCULATED VALUES

1 THb ON 2 pH (T) ON 3 PCO

(T) ON

4 PO

(T) ON

5 TCO

CONFIRM ?

SET REFERENCE LIMITS 1/2

QC LEVEL 1

LOT #XXXXXXX

pH X.XXX-X.XXX

XXX.X-XXX.X mmHg

PCO

XXX- XXX mmHg

CONFIRM ?

SET REFERENCE LIMITS

QC Hct LEVEL 1

LOT #XXXXXXX Hct XX

XX %

QC Hct LEVEL 2

LOT #XXXXXXX

Hct XX

CONFIRM ?

SET REFERENCE LIMITS 1/6

Rili-BAK LEVEL 1 LOT #XXXXXXX

TARGET X.XXX mmHg DEVIATION X.X % RILIBAK X.XXX

TARGET XX %

DEVIATION XX % RILIBAK

SET REFERENCE LIMITS

TARGET XX % DEVIATION XX % RILIBAK

CONFIRM ?

SET REFERENCE LIMITS

Rili-BAK LEVEL 1

LOT #XXXXXXX

Hct

XX-XX %

CONFIRM ?

Rili-BAK LEVEL 2

LOT #XXXXXXX

Hct

CONFIRM ?

XX %

X.XXX mmHg

XX %

CORRELATION 2/2 SET PARAMETERS SLOPE INTERCEPT

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

= X.XXX + X.XX mmol/L

CONFIRM ?

REPORTED PATIENT DATA 2/2

ANALYTES

1 Na+ ON

2 K

3 Ca

CONFIRM ?

REPORTED PATIENT DATA 2/3

CALCULATED VALUES

1 HCO3 ON 2 BEb ON 3 BEecf ON 4 SBC ON

5 %s0

CONFIRM ?

SET REFERENCE LIMITS 2/2

QC LEVEL 1

LOT #XXXXXXX

XXX.X

K Ca

SET REFERENCE LIMITS 2/6

TARGET X.XXX mmHg DEVIATION X.X % RILIBAK X.XXX

XXX.X mmol/L

X.XX X.XX mmol/L

CONFIRM ?

Rili-BAK LEVEL 1

LOT #XXXXXXX

pCO

X.XXX mmHg

CONFIRM ?

REPORTED PATIENT DATA 3/3

1 ctO2 ON 2 A-aDO 3 RI ON

4 Ca

CONFIRM ?

CALCULATED VALUES

(7.4)

PATIENT INFORMATION 1/2

1 PATIENT ID OFF 2 PATIENT TEMP OFF 3 Hb OFF 4 FI O

5 TIME DRAW N OFF

CONFIRM ?

DELETE DATA

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 RESULT S

SET AMR LIMITS 1/2

pH X.XXX-X.XXX PCO PO

Hct XX

SET NORMAL LIMITS

1 ARTERIAL 2 MIXED VENOUS 3 VENOUS

SET CRITICAL LIMITS

1 ARTERIAL 2 MIXED VENOUS 3 VENOUS

OFF

PATIENT INFORMATION 2/2

1 SAMPLE TYPE OFF 2 SAMPLE SITE OFF 3 OPERAT OR ID OFF

CONFIRM ?

XXX.X-XXX.X mmHg

XXX-XXX mmHg

XX %

CONFIRM ?

SET AMR LIMITS 2/2

Na+ XXX.X-XXX.X mmol/L

X.XX-X.XX mmol/L

CONFIRM ?

SET REFERENCE LIMITS 1/2

NORMAL

ARTERIAL

pH X.XXX-X.XXX PCO

XXX.X-XXX.X mmHg

XXX-XXX mmHg

Hct XX

CONFIRM ?

SET REFERENCE LIMITS 1/2

pH X.XXX-X.XXX PCO PO Hct XX

CONFIRM ?

XX %

CRITICAL

ARTERIAL

XXX.X-XXX.X mmHg

XXX-XXX mmHg

XX %

SET REFERENCE LIMITS 2/2

NORMAL

ARTERIAL

XXX.X mmol/L

XXX.X

X.XX-X.XX mmol/L

CONFIRM ?

SET REFERENCE LIMITS 2/2

CRITICAL

ARTERIAL

Na+ XXX.X-XXX.X mmol/L

X.XX-X.XX mmol/L

CONFIRM ?

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STORED INFORMATION

1 PATIENT RESULTS 2 QC RESULTS 3 REFERENCE LIMITS 4 CAL/SAMPLE # DATA 5 REAGENT MODULE 6 PRINTOUTS

PATIENT RESULTS

1 LAST 2 ALL 3 ENTER ID#

QC RESULTS

1 LAST CONTROL 2 PRINT QC STATS 3 PRINT QC RESULTS 4 PLOT QC CHARTS 5 FAILED QC

LAST CONTROL

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVEL 1 5 Hct LEVEL 2

REFERENCE LIMITS

1 QC 2 NORMAL 3 CRITICAL 4 AMR

PRINT QC STATS

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVEL 1 5 Hct LEVEL 2 6 ALL LEVELS

PLOT QC CHARTS

1 pH 2 PCO 3 PO 4 Hct

FAILED QC

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVEL 1 5 Hct LEVEL 2

QC REFERENCE LIMITS

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVELS

Rili-BAK LIMITS

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVEL 1 5 Hct LEVEL 2

5 Na

6 K

7 Ca 8 ALL CHARTS

DEC-16 13:57

pH X.XXX PCO PO Na

K Ca

REMOVE FROM STATS ?

DEC-16 13:57

XXX.X

XXX

2 +

XXX.X X.XX

X.XX

Hct LEVEL 1

X.XX %

1/XX

REMOVE FROM STATS ?

DEC-16 13:57

Hct LEVEL 2

1/XX

X.XX %

REMOVE FROM STATS ?

REFERENCE LIMITS 1/2

QC LEVEL 1

LOT # XXXXXXX

pH X.XXX

PCO PO

REFERENCE LIMITS 1/6

TARGET X.XXX mmHg DEVIATION X.XX % RILIBAK X.XXX

TARGET XX % DEVIATION X.X % RILIBAK

X.XXX

XXX.X-XXX.X mmHg

XXX-XXX mmHg

REFERENCE LIMITS

QC Hct LEVEL 1 LOT #XXXXXXX

Hct XX

XX % QC Hct LEVEL 2 LOT #XXXXXXX

Hct XX

XX %

CONFIRM ?

Rili-BAK LEVEL 1

LOT #XXXXXXX

X.XXX mmHg

REFERENCE LIMITS

Rili-BAK LEVEL 1 LOT #XXXXXXX

Hct

XX-

XX %

REFERENCE LIMITS

Rili-BAK LEVEL 2

LOT #XXXXXXX

Hct

XX-

XX %

DEC-16 13:57

pH X.XXX PCO PO

XXX

2 +

REFERENCE LIMITS 2/2

QC LEVEL 1

LOT # XXXXXXX

Na+ XXX.X-XXX.X mmol/L

X.XX-X.XX mmol/L

REFERENCE LIMITS 2/6

Rili-BAK LEVEL 1

LOT #XXXXXXX

TARGET X.XXX mmHg DEVIATION X.XX % RILIBAK X.XXX

XXX.X

XXX.X X.XX X.XX

CONFIRM ?

pCO2

1/XX

X.XXX mmHg

DEC-12 16:25

pH X.XXX PCO PO

2 +

REMOVE FROM STATS ?

XXX.X

XXX

XXX.X X.XX X.XX

2/XX

CAL / SAMPLE # DATA

1 SLOPES 2 mV’s 3 PUMP / BUBBLE DETECTOR 4 SAMPLE COUNTER

REAGENT MODULE

1 STATUS 2 CONCENTRATIONS

PRINTOUTS

1 USER OPTIONS 2 CONFIGURATION 3 PRINTER OPTIONS 4 PATIENT LIMITS 5 QC LIMITS 6 PATIENT INFORMATION

REFERENCE LIMITS 1/2

AMR

pH X.XXX-X.XXX PCO

XXX.X-XXX.X mmHg

XXX-XXX mmHg

NORMAL LIMITS

1 ARTERIAL 2 MIXED VENOUS 3 VENOUS

CRITICAL LIMITS

1 ARTERIAL 2 MIXED VENOUS 3 VENOUS

SLOPES

pH 23.99 PASS PCO

34.00 PASS

99.99 PASS

Hct 87.34 PASS

10.78 PASS

41.00 PASS

30.00 PASS

CAL / SAMPLE # DATA 1/2

mv’S

CAL A CAL B CAL C pH XX.X XX.X XX.X PCO

XX.X XX.X XX.X

PO2 XX.X XX.X XX.X Hct XX.X XX.X XX.X

REAGENT MODULE

STATUS

S/N 0001-0200-03-001

INSTALLED DEC-05-01 UNIT S/N 0123456789

98 %, 30 DAYS

REAGENT MODULE 1/3

CONCENTRATIONS

Cal pH PCO2 PO2 mmHg mmHg

A X.XXX XXX.X XXX B X.XXX XXX.X XXX C X.XXX XXX.X XXX

REFERENCE LIMITS 2/2

AMR

Na+ XXX.X-XXX.X mmol/L

X.XX-X.XX mmol/L

Hct XX

REFERENCE LIMITS 1/2

pH X.XXX-X.XXX PCO PO Hct XX

REFERENCE LIMITS 1/2

pH X.XXX-X.XXX PCO PO Hct XX

CAL / SAMPLE # DATA 2/2

Na K Ca

Cal Hct Na+ K+

% nmol/L nmol/L A XX XXX.X XX.X B XX XXX.X XX.X C XX XXX.X XX.X

XX %

NORMAL

ARTERIAL

XXX.X-XXX.X mmHg

XXX-XXX mmHg

XX %

CRITICAL ARTERIAL

XXX.X-XXX.X mmHg

XXX-XXX mmHg

XX %

mv’S

CAL A CAL B CAL C

XX.X XX.X XX.X

REAGENT MODULE 2/3

CONCENTRATIONS

REFERENCE LIMITS 2/2

NORMAL

ARTERIAL

Na+ XXX.X-XXX.X mmol/L

X.XX-X.XX mmol/L

REFERENCE LIMITS 2/2

CRITICAL

ARTERIAL

Na+ XXX.X-XXX.X mmol/L

X.XX-X.XX mmol/L

X.XX-X.XXX mmol/L

REAGENT MODULE 3/3

CONCENTRATIONS

Cal Ca++ nmol/L A X.XXX B X.XXX C X.XXX

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\EDIC@

EasyStat

Operator’s Manual

Ref. 7415

003770-901R1, 2015-07

Page 6

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.

Page 7

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

biohazard warning

sampler positioning required by operator

syringe sample mode

capillary sample mode

compression plate positioning required by operator

DISPLAY TYPE

conditions which may cause data loss or analyzer malfunction

access door must be closed for proper operation

Page 8

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

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6 Principles of Operation/Theory

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

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

PO2 Electrode .............................................................................................................................. 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

10 Computer Connection

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

11 Replacement Schedule

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

Appendices

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

Appendix B: Understanding the Symbols ...................................................................................... 14 9

Page 10

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1. Understanding the EasyStat Analyzer

Intended Use

The EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PO2 (partial pressure of oxygen), Hct (Hematocrit), Na+ (sodium), K+ (potassium), and Ca++ (ionized Calcium) or Cl- (chloride) on whole blood samples from syringes or capillary tubes.

Ca++ (ionized calcium) and Cl- (chloride) electrodes are interchangeable on the analyzer. The EasyStat can only measure Ca++ (ionized calcium) or Cl- (chloride) at one time. After switching to the EasyStat (Chloride) mode, the new Cl- electrode will occupy the same position as the Ca++ electrode.

This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid-base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall patient clinical condition before corrective/therapeutic action is taken.

The EasyStat analyzer also calculates the following parameters, based on the equations outlined under Calculations in Principles of Operation/Theory.

Total Hemoglobin: THb

•

• Temperature corrected pH: pH(T)

Temperature corrected PCO

•

Temperature corrected PO

•

Total Carbon Dioxide: TCO

•

Bicarbonate: HCO

•

Base Excess of blood: BE

•

Base Excess in extracellular fluid: BE

•

Standard Bicarbonate: SBC

•

Oxygen Saturation calculated at normal P

•

: PCO2(T)

: PO2(T)

ecf

: %SO2c

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u n d e r s t a n d i n g t h e a n a l y z e r

•

Total Oxygen Content: ctO

•

Alveolar-Arterial O

Respiratory Index: RI

•

Gradient: A-aDO

• Normalized calcium at pH = 7.4: Ca++ (7.4) when Ca++ channel is selected

• Anion Gap, when Cl- channel is selected

Operational Hazards and Precautions

Read the Operator’s Manual before setting up or operating the EasyStat analyzer.

Observe all Warnings, Notes, and Key Information in this manual.

Failure to leave the analyzer connected to power with a reagent module in place could damage the electrodes, sensor module, valve module, and pump tubing.

There are no operator serviceable parts inside the analyzer. When electromechanical problems beyond the scope of this Operator’s Manual are suspected, DO NOT open the back cover. Contact your EasyStat dealer.

Use only the supplied 3-wire (UL approved) power cord, or equivalent. The power cord of the analyzer must be connected to a matching grounded outlet supplying 110~VAC, 50/60 Hz or 220~VAC, 50/60 Hz. The analyzer contains sensitive electronics and must be properly grounded.

DO NOT plug the analyzer into a circuit protected by a Ground Fault Interrupter (GFI).

The safety protection provided by the analyzer may be impaired when the analyzer is used in any way other than as is outlined in this manual.

Page 13

u n d e r s t a n d i n g t h e a n a l y z e r

BIOHAZARD

All biological samples should be considered biohazardous.

Any replaceable component which comes in contact with biological samples, including the sample probe, electrodes, sensor module, pump tubing, valve module and reagent module may contain contaminated material. Treat all components, during use and disposal, as you would any biohazardous material.

To clean the outside surfaces of the EasyStat analyzer, use a cleaning agent consisting of a 10% bleach (0.4-0.6% NaClO) solution. Dampen a cloth with solution to wipe down all outside surfaces. Protective clothing and gloves are recommended. Refer to the Analyzer Surface Cleaning/Storage instructions outlined under Replace Components in Operating the Analyzer.

To clean any component, use only water or bleach (NaClO) solutions. DO NOT use solvents (examples: methyl alcohol, ethyl alcohol, isopropyl alcohol).

Page 14

2. Analyzer Layout

Front View

Page 15

Rear View

a n a l y z e r l a y o u t

Fuse

Voltage

Frequency

Current

Single phase alternating current

\EDI

See operator’s manual for instructions.

RS-232 serial interface connection.

Barcode reader connection. (Use only an

EasyStat barcode reader.)

Battery port connection. (Use only an

EasyStat battery module.)

Page 16

a n a l y z e r l a y o u t

Keypad

Press to correct an entry or return to the previous screen.

In addition to numerical inputs, the 0 and 9 keys each have one additional function.

Press to return to HOME MENU.

Press to advance printer paper.

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Display

To adjust the display, proceed to the SECOND MENU and select ADJUST DISPLAY. Press the number 1 or number 2 keys to

adjust the brightness. Press the number 3 key to reverse the contrast of the display.

a n a l y z e r l a y o u t

Page 18

a n a l y z e r l a y o u t

Fluid Path / Module Description

Ca++/Cl- ELECTRODE

s Cl

electrode should be installed when Cl- mode is selected.

Page 19

Reagent Module

Disposable module contains all reagents and a waste container. The reagent module is equipped with an electronic chip which contains

encoded information which is automatically read by the analyzer upon installation of the reagent module. This information includes:

calibrant concentrations for pH, PCO2, PO2, Hct, Na+, K+, Ca++,

and Cl-;

current reagent module serial number and installation date;

analyzer serial number that the reagent module was first installed

on;

reagent volume % remaining with the number of days remaining

before calibrants expire.

a n a l y z e r l a y o u t

Prior to installation, a reagent module must be stored at room temperature for a minimum of four hours. When the center of the indicator on the back of the reagent module becomes dark, the module has been exposed to excessive heat and must not be used.

After initial installation, the reagent module is functional for a limited number of days (see reagent module insert sheet). After each calibration, the reagent module % and days remaining are printed. When the reagent module has 0% remaining, RGNT MODULE EMPTY is displayed. If the reagent module has exceeded the allowable usage period, RGNT MODULE EXPIRED is displayed. Both of

these conditions require reagent module replacement.

Valve Module

Selects reagents from the reagent module, preheats and directs them through the probe.

Sensor Module

Thermostated housing for the electrodes. The sampler containing the probe is attached. A bubble detector above the electrodes detects fluid or air in the fluid path.

Page 20

3. Analyzer Installation

Unpacking

Carefully remove the EasyStat analyzer and accessories from the shipping containers and place them on a solid work surface. Visually inspect for any damage sustained during shipment. If damage is found, or if items are missing, promptly notify your dealer.

PO2 Electrode

PCO2 Electrode

pH Electrode

Na+ Electrode

K+ Electrode

Power Cord

Reagent Module

Ca++/Cl- Electrode

Reference Electrode

EasyStat Analyzer with Valve Module, Sensor Module, Pump Tubing

s Cl

electrode should be installed when Cl- mode is selected.

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a n a l y z e r i n s t a l l a t i o n

Location

The analyzer operates in the ambient (room) temperature range from 15° to 30°C (59° to 86°F) with a maximum relative humidity of 85%, and a barometric pressure range of 500-800 mmHg. The analyzer must operate in a normal atmosphere of 21% oxygen. Choose a location which provides good ventilation and is free from vibration and electrical interferences.

Troubleshooting Kit

Quality Controls

Hct Controls, Bi-Level

Daily Cleaning Solution Kit

Operatorʻs Manual

Operator’s Manual

Printer Paper

Page 22

tory-set

r Voltage Settin

a n a l y z e r i n s t a l l a t i o n

Power Up

Before connecting the analyzer to power, confirm that the factory set voltage (110V or 220V) of the EasyStat analyzer matches the grounded outlet supplying the power. When factory set to 110V, the installed fuses are 0.8 amp. When factory set to 220V, the installed fuses are

0.4 amp. If it is necessary to switch the EasyStat voltage setting, the correct fuses must be installed. Refer to Replace Components/Fuses, or contact your EasyStat dealer.

\EDIC@

use Holder

220

Power Cord Socket

HDo not install reagent module or electrodes at this time.

When the analyzer is powered up, the display will prompt you to set the correct date and time.

Page 23

1 QC 2 NORMAL 3 CRITICAL 4 AMR

REFERENCE LIMITS

1 PO2 / PCO2 / BP mmHg 2 Na

+ / K+

/ Ca

mmol/L 3 Hct % 4 Hb

g/dL

5 BC CHECKSUM OFF

CONFIRM ?

CONFIGURATION 1/2

1 CAL FREQUENCY 8 HRS 2 AUTO STANDBY OFF 3 TEMPERATURE C 4 Rili-BAK OFF 5 AMR OFF

CONFIRM ?

CONFIGURATION 2/2

a n a l y z e r i n s t a l l a t i o n

Date/Time

The EasyStat analyzer has a 24 hour internal clock. At the DATE/TIME display, press NO to change the month and YES to accept. Press the number keys to enter the day, year and time, accepting each with YES, or pressing NO to move to the left to correct an entry. Press YES to CONFIRM? to accept the DATE/TIME.

For optional operator-selected settings, proceed to SECOND MENU, SETUP MENU.

sCa

is replaced with Cl- when Cl- mode is selected.

Page 24

a n a l y z e r i n s t a l l a t i o n

Components

Press the raised dots on the access door to open, and familiarize yourself with the EasyStat analyzer components. The access door must remain closed during operation to maintain a temperature of 37.0º C.

Prior to installing the electrodes, select ELECTRODES under

REPLACE COMPONENTS in the SECOND MENU.

Electrodes

To install the electrodes, push the compression plate down until the latch locks into the open position.

Install the reference electrode first, pushing it in above the compression plate. The handle snaps into the sensor module.

Next, install the Ca++, K+, Na+, pH, PCO2 and PO2 electrodes, beginning from the bottom and proceeding upward. Each handle should snap into the sensor module. The electrodes are keyed to assure correct placement. DO NOT FORCE. Refer to the illustration and the access door label for correct electrode order and location.

Release the compression plate to compress the electrodes within the sensor module.

Page 25

Pump Tubing

Install the pump tubing.

a n a l y z e r i n s t a l l a t i o n

Push the two middle collars completely into the back of the slots on the pump shelf.

Page 26

a n a l y z e r i n s t a l l a t i o n

Reagent Module

Place the reagent module into the front of the analyzer. The guide arrow must point to the right side of the reagent module. Push the module straight back, then firmly to the right to lock it into place against the valve module. When correctly installed, the message RGNT MODULE IN is printed. When the reagent module is installed, press yes to CONFIRM?.

Page 27

a n a l y z e r i n s t a l l a t i o n

When the installed reagent module has less than 10% remaining, the HOME MENU display will flash the % remaining. Prepare to install a new reagent module when the % remaining reaches zero.

When all components are installed, confirm that the access door is closed. WARMING UP appears at the bottom of the HOME MENU display. When the sensor module reaches 37.0°C and the valve module reaches 39.0°C (approximately 30 minutes from a cold start) the WARMING UP message disappears. Calibration can now be performed. Refer to Calibrate in Operating the Analyzer for further instructions.

New electrodes require a short stabilization period to prevent drift errors. This stabilization is minimized by the analyzer, which performs calibrations every hour for 8 hours. After this stabilization period, the analyzer will calibrate at the calibration frequency selected under

CAL FREQUENCY in the CONFIGURATION section of the SETUP MENU.

Page 28

LIFT SAMPLER TO

ANALYZE

Hct Na

TIO

HOME MENU

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

HOME MENU

ANALYZE SAMPLE

ANALYZE QC

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

SLOPES

61.02

PCO253.17

Hct.88

58.98

61.50

24.62

CALIBRATION

BUBBLE

DETECTOR

CAL

air fluid

BD PASS 171 030

PUMP CAL

PUMP PASS 0799

REAGENT

MODULE

STATUS

021%, 15 DAYS

JUNE-05-20

;13:35

4. Operating the Analyzer

Calibrate

The EasyStat analyzer requires a two-point calibration after installation and warm-up. Automatic two-point calibrations occur at pre-selected intervals chosen under CAL FREQUENCY in the CONFIGURATION section of the SETUP MENU. Automatic Hct calibrations are included in each two-point calibration. Ondemand two-point calibrations can be initiated in the HOME MENU by choosing CALIBRATE. If not calibrated, the HOME MENU

3.0

only displays options 3, 4 and 5.

The ACCESS DOOR must be closed during warm-up, calibration, and sampling.

Select CALIBRATE to perform a two-point calibration and prepare the EasyStat analyzer for sample analysis. The analyzer displays the calibration status. Bubble detector and pump cal results are printed at completion. After a successful calibration, the analyzer displays and prints the slope of each electrode, the % of calibrants remaining, and the number of days before expiration. After completion of a successful calibration, the analyzer displays LIFT SAMPLER TO

ANALYZE pH PCO2 PO2 Hct Na+ K+ Ca++.

is replaced with Cl- when Cl- mode is selected.

Page 29

o p e r a t i n g t h e a n a l y z e r

In addition to calibration, analysis of quality control material is required to verify the performance of the EasyStat analyzer. This procedure is outlined under Analyze QC in this chapter.

The EasyStat analyzer is factory set to perform automatic twopoint calibrations every eight hours. To change the setting, proceed to the SECOND MENU and select SETUP MENU, then CONFIGURATION, and CAL FREQUENCY.

A two-point calibration can be interrupted to perform stat samples. Press NO and STOP CALIBRATION? is displayed. Press YES and SYSTEM CALIBRATION INTERRUPTED is displayed before returning to the HOME MENU for sample analysis. When the sampler is raised during calibration, the display prompts you to

RETURN SAMPLER

the closed position, the message SYSTEM INTERRUPTED HOME MENU.

appears for 10 seconds before returning to the

No more than three interruptions are permitted dur-

. When the sampler is returned to

CALIBRATION

ing a scheduled calibration.

When an electrode does not calibrate successfully, that parameter will not appear on the screen. A parameter will not be displayed or printed if PATIENT DATA is turned off under USER OPTIONS in the SETUP MENU. The reporting of specific analytes is disabled under REPORTED PATIENT DATA. No sample results (including dependent calculated results) are given for that electrode. Refer to ELECTRODES in Troubleshooting.

The analyzer will display any error detected during calibration. If an error occurs, the analyzer will automatically attempt a second twopoint calibration. If this fails, troubleshooting may be required.

During each sample analysis, the EasyStat analyzer performs a onepoint calibration.

Page 30

yes

SAMPLE # XXX

ANALYZING SAMPLE

SAMPLE # XXX

PROBE IN SAMPLE?

SAMPLE # XXX

REMOVE SAMPLE

RETURN SAMPLER

SAMPLER TO

LIFT SAMPLER TO

ANALYZE

Hct Na

K Ca

yes

HOME MENU

ANALYZE SAMPLE

2 ANALYZE QC

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

SAMPLE # XXX

ASPIRATING...

CALCULATED VALUES

SCREENS

RETURN SAMPLER

ONE MOMENT...

ANALYSIS RESULTS #001

7.403

PCO232.5 mmH

mmH

Hct45%

Na.1

mmol/L

4.02 mmol/L

Ca.33 mmol/L

o p e r a t i n g t h e a n a l y z e r

Analyze Sample

The ACCESS DOOR must be closed during sample analysis.

Select ANALYZE SAMPLE. The display shows LIFT

SAMPLER TO ANALYZE pH PCO2 PO2 Hct Na+ K+ Ca++. When an electrode does not calibrate successfully, that

parameter will not be displayed on the screen. No sample results (including dependent calculated results) are given for that electrode. Refer to ELECTRODES in Troubleshooting.

sCa

is replaced with Cl- when Cl- mode is selected.

Page 31

o p e r a t i n g t h e a n a l y z e r

The EasyStat sampler is designed for two separate sample entry modes. To select the sampling mode, place your thumb on the raised dots under the corresponding symbol, and push up to lift the sampler for syringe or capillary samples.

Thumb placement for syringe samples. Push up.

Thumb placement for capillary samples. Push up.

Page 32

o p e r a t i n g t h e a n a l y z e r

Syringe Mode

To analyze samples from blood gas syringes (120 µL minimum), lift the sampler until PROBE IN SAMPLE? is displayed.

When using a syringe, it is important that the sample probe does

not touch the plunger of the syringe. If this occurs, the resulting vacuum can damage the electrodes. The air in the syringe should be expelled immediately and completely upon sampling. Samples unexposed to air and preserved in ice water must be analyzed within 30 minutes.

Place the probe in the sample and press YES. Hold the syringe in place, keeping the probe submerged in the sample until REMOVE SAMPLE RETURN SAMPLER is displayed.

Push the sampler down into the closed position. If PATIENT INFORMATION settings are turned ON in the SETUP MENU, the ENTER PATIENT DATA? screen displays for 30 seconds. Press YES to enter patient information (2 minutes is allowed), or NO to continue. Analysis begins when the sample is automatically positioned inside the electrodes.

Page 33

o p e r a t i n g t h e a n a l y z e r

If the sampler is not returned within two minutes of aspiration the sample will be pumped to waste

Sample analysis can be interrupted by pressing NO. STOP

ANALYSIS? is displayed. Press YES and ANALYSIS INTERRUPTED is displayed before returning to the LIFT SAMPLER TO ANALYZE pH PCO2 PO2 Hct Na+ K+ Ca++ screen.

When analysis is complete, the measured results are printed with the current sample number. The measured results are reported in mmHg for blood gas parameters and mmol/L for electrolytes. When alternate units are on (refer to CONFIGURATION in the SETUP MENU), blood gas results are expressed in KPa and electrolytes are expressed in mEq/L.

Results are automatically printed after each analysis if the printer is turned on under CONFIGURATION in the SETUP MENU. The measured results are compared to the normal and critical limits set under SET REFERENCE LIMITS in the SETUP MENU. When analysis results are in the critical range, they are flagged as low (↓↓) or high (↑↑) on both the display and the printout. Patient results that are outside the normal range, and not in the critical range will be flagged as low (↓) or high (↑) on the display and printout. If any result is not within the analyzer’s measurement range, the result is displayed and printed as — e.g., pH < 6.50 ↓↓ or pH > 8.00 ↑↑. The display will show < 6.50 ↓↓ or > 8.00 ↑↑ blinking on and off. The analyzer displays CALCULATED VALUES?. The calculated results print with the measured results. View the calculated values by pressing YES.

sCa

is replaced with Cl- when Cl- mode is selected.

Page 34

o p e r a t i n g t h e a n a l y z e r

ecf

Calculated values for THb, pH(T), PCO2(T), PO2(T), TCO2, HCO and BE display screen. Press YES to view the calculated results for BE SBC, %SO2c, O2ct, A-aDO results use the following default values, if patient values were not entered (see PATIENT INFORMATION screen in the SETUP MENU):

Patient Temp 37°C Hb 14.5 g/dL FIO2 21%

User entered correlation values are applied to the measured results to provide the displayed and printed results. If correlations are applied, reported results will be printed as CORRELATION APPLIED results. Refer to CORRELATION under USER OPTIONS in

the SETUP MENU for more information.

are displayed. MORE DATA? appears at the top of the

RI and Ca++ (7.4). The calculated

s In Cl

mode, Ca++ (7.4) is replaced with Anion Gap.

Page 35

o p e r a t i n g t h e a n a l y z e r

Capillary Mode

To analyze samples from capillary tubes (95 µL minimum), lift the sampler until

CAPILLARY INSERTED?

is displayed.

Note: Use only the Medica capillary kit. Use of other capillary tubes may result in erroneous results or damage to the analyzer and electrodes.

The capillary should be filled entirely with no visible air bubbles.

Seal the ends with caps. Analyze the capillary sample within 10 minutes of sampling.

Insert the capillary tube into the capillary port. When inserted, press YES and the sample is aspirated.

RETURN SAMPLER is displayed.

REMOVE CAPILLARY

Push the sampler down into the closed position. If PATIENT

INFORMATION settings are turned ON in the SETUP MENU,

ENTER PATIENT DATA? screen displays for 30 seconds.

the Press YES to enter patient information (2 minutes is allowed), or NO to continue. Analysis begins when the sample is automatically positioned inside the electrodes.

Sample analysis can be interrupted by pressing NO.

ANALYSIS? is displayed. Press YES and ANALYSIS INTERRUPTED is displayed before returning to the LIFT SAMPLER TO ANALYZE pH PCO2 PO2 Hct Na

screen.

STOP

+ K+

sCa

is replaced with Cl- when Cl- mode is selected.

Page 36

o p e r a t i n g t h e a n a l y z e r

When analysis is complete, the measured results are printed with the current sample number. The measured results are reported in mmHg for blood gas parameters and mmol/L for electrolytes. When alternate units are on (refer to CONFIGURATION in the SETUP MENU ), blood gas results are expressed in KPa and electrolytes are expressed in mEq/L.

Page 37

o p e r a t i n g t h e a n a l y z e r

The analyzer displays CALCULATED VALUES?. The calculated results are printed with the measured results. View the calculated values by pressing YES. Calculated values for THb, pH(T), PCO

(T), TCO2, HCO

, and BEb are displayed. MORE DATA?

(T),

appears at the top of the display screen. Press YES to view the calculated results for BE

, SBC, %SO2c, O2ct, A-aDO2, RI, and Ca++

ecf

(7.4). In Cl- mode, Ca++ (7.4) is replaced with Anion Gap.The calculated results use the following default values, if patient values were not entered (see PATIENT INFORMATION screen in the SETUP MENU):

Patient Temp 37°C Hb 14.5 g/dL

21%

FIO

Page 38

yes

ANALYZE QC

LEVEL

2 QC LEVEL

3 QC LEVEL

4 Hct Level

5 Hct Level

6 PROFICIENCY

HOME MENU

ANALYZE SAMPLE

2 ANALYZE QC

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

QC LEVEL

LOT # XXXXXXXX

LIFT SAMPLER TO

ANALYZE CONTROL

QC LEVEL

LOT # XXXXXXXX

PROBE IN CONTROL?

QC LEVEL

LOT # XXXXXXXX

ASPIRATING...

QC LEVEL

LOT # XXXXXXXX

REMOVE CONTROL

RETURN SAMPLER

QC LEVEL

LOT # XXXXXXXX

ANALYZING CONTROL

ONE MOMENT...

RETURN SAMPLER

QC LEVEL

X.XXX

PCO

XXX.X mmol/L

X.XX mmol/L

STORE RESULTS?

o p e r a t i n g t h e a n a l y z e r

Analyze QC

XX.X mmH XXX mmH

The ACCESS DOOR must be closed during analysis.

Page 39

o p e r a t i n g t h e a n a l y z e r

As with all clinical instrumentation, the performance of the EasyStat analyzer must be monitored using quality control samples. Each laboratory should establish their own quality control program. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting.

Medica controls are designed to contain pH, PCO

, PO2, Na+, K+, Ca++,

and Cl- values that are within the typical patient population. Each lot of EasyStat control contains an insert sheet indicating the expected ranges for pH, PCO

, PO2, Na+, K+, Ca++, and Cl-. Using the 3 levels of controls as

part of the laboratory quality control program will aid in verifying analyzer performance. If controls have results outside the expected ranges, the performance of the analyzer may not be optimum. If necessary, corrective action should be taken before reporting patient results. Factors that can shift control results from the insert sheet ranges are:

l

control material temperature when ampule is opened (PO2 control values increase by 1.3% for every 1°C decrease in storage temperature from 23°C or PO2 control values decrease by 1.3% for every 1°C increase in storage temperature from 23°C)

l

elevation (PO2 control values decrease by 1% for every 1000 feet (305m) above sea level)

l

correlation factors applied to quality control samples

The hematocrit controls are assayed quality control materials used to monitor the measurements of hematocrit in the EasyStat analyzer. Electrical conductivity methodologies are used to determine hematocrit.

Medica hematocrit controls are designed to contain hematocrit values that are within the typical patient population. Each lot of control contains an insert sheet indicating the expected ranges for hematocrit. The values for each control analyte are based on multiple determinations performed on randomly selected samples from each lot. The expected range and mean values shown are provided as a guide in evaluating analyzer performance. The mean value established should fall within the expected value range shown on the chart provided.

As part of a good quality control program, each laboratory should establish their own ranges for each lot of controls over multiple days. The ranges must be examined for clinical significance.

Once established, enter the limits into the EasyStat analyzer under SET REFERENCE LIMITS in the SETUP MENU.

The EasyStat stores quality control results for 3 levels (a maximum of 93 for each level) when control samples are analyzed through ANALYZE QC. The results for pH, PCO

, PO2, Hct, Na+, K+, Ca++, and Cl- are compared

to the quality control reference limits previously entered for the chosen level of quality control. Levey-Jennings charts can be printed to document the performance of the stored quality control sample results over time.

Page 40

o p e r a t i n g t h e a n a l y z e r

QC REFERENCE LIMITS

1 LEVEL 1 2 LEVEL 2 3 LEVEL 3 4 Hct LEVELS

Quality Control Settings

Quality control limits and lot numbers must be entered for each new lot of quality controls, before selecting ANALYZE QC from the

HOME MENU. Proceed to the SECOND MENU and select SETUP MENU, then REFERENCE LIMITS. Select QC, then LEVEL 1, LEVEL 2, or LEVEL 3, or Hct Levels.

It is recommended that any stored quality control results be deleted prior to entering information for a new lot of quality controls. Refer to DELETE DATA in the SETUP MENU.

Select LEVEL 1, 2, 3, or Hct LEVELS to enter the limits and lot number each time a new lot of controls is introduced. The display lists pH, PCO then use the number keys to enter the new lot number and limits. Press YES to confirm each and move to the next entry. When all entries are complete, press YES to CONFIRM?. If NO is pressed as a response to CONFIRM?, the settings can be corrected. Repeat for each level of control. To proceed with quality control analysis, press to HOME MENU.

, PO2, Hct, Na+, K+, or Ca

limits.* Press NO,

to return

If RiliBAK feature is on, press NO and use the number keys to enter the lot number and the target from the package insert. The analyzer calculates the limits using the RiliBAK percent deviation and target value. The percent deviation or the RiliBAK limits can be changed manually using the number keypad. Press YES to confirm the entry and advance to the next entry.

To enter quality control information using the barcode reader, Medica quality controls must be used.

To enter quality control information using the barcode reader, Select LEVEL 1, 2, 3, or Hct LEVELS. LOT # is highlighted on the display. Using the barcode reader, scan in the lot number provided on the quality control insert sheet. Next, the parameter will be highlighted. Scan in the parameter range (verify that the displayed range matches the insert sheet). Repeat for remaining parameters. When all entries are complete, press YES to CONFIRM?. When NO is pressed as a response to CONFIRM?, the settings can be corrected. Repeat for each level of control. To proceed with quality

control analysis, press

to return to HOME MENU.

*Cl- limits will be listed for Cl- (Chloride) mode.

Page 41

Quality Control Analysis

o p e r a t i n g t h e a n a l y z e r

Follow the manufacturer’s storage and handling instructions for quality control material before proceeding with quality control analysis.

The Easy QC materials are aqueous solutions with gasses dissolved in them along with other components necessary to qualify the electrodes. Prior to the testing of these materials, careful attention needs to be paid to the instructions. If the ampules are not prepared and handles as instructed, erroneous readings may result.

Refer to the insert sheet enclosed in the Easy QC package for proper handling instructions.

The sampler must be in the syringe mode position.

Select ANALYZE QC for Level 1, 2, 3 or Hct. Select the desired level. Break open the quality control ampule and analyze immediately.

Lift the sampler and PROBE IN CONTROL? is displayed.

Place the probe in the quality control material and press YES. Hold the ampule in place, keeping the probe submerged in the ampule until REMOVE CONTROL RETURN SAMPLER is displayed. Push the sampler down into the closed position. The quality control is analyzed and results for each parameter are displayed and printed. Results falling outside the quality control limits are flagged as (↓) low or (↑) high.

Three quality control results for each level are automatically stored

each day when no errors are detected. When more than three of a control level are performed on the same day, the three most recent results replace the results previously stored for that day. The EasyStat analyzer stores up to 93 quality control results for each level.

If a result is outside the limits or an error occurs, a STORE RESULTS? prompt is displayed. Press YES to store quality control results, or NO to reject the results.

If selected, quality control correlation factors will be applied to results.

Page 42

o p e r a t i n g t h e a n a l y z e r

Proficiency

To analyze proficiency samples, select PROFICIENCY under ANALYZE QC. These samples are analyzed without applying cor-

relation values to the measured results, which enables the EasyStat results to be grouped together on the proficiency program’s interlaboratory reports. The proficiency results are not stored.

Stored QC Information

Select STORED INFORMATION from the SECOND MENU, then QC RESULTS to view the last quality control results, print QC statistics or plot QC charts. PRINT QC STATS prints the results by date, mean, standard deviation, and coefficient of variation for the stored quality control results. PLOT QC CHARTS prints the stored quality control results as a Levey-Jennings chart. The statistics are calculated according to the following definitions:

A minimum of 5 stored quality control results is required to calculate statistics.

Definitions

Mean: The mean (x) is the value derived by dividing the sum (Σ) of the observed values by the number of observations (n) stored in memory (between 5 and 93 values).

SD: The standard deviation (SD) measures dispersion within the distribution of data stored.

where: SD =

x =

Σ values

(x-x)

n-1

Σ(x-x)

n = number of observations

sum of the square of each difference from the mean

CV:

The coefficient of variation (CV) is a measure (as a percentage) of the variation from the mean within the set of stored data.

CV = 100 SD

Page 43

00000000

008

382

Levey-Jennings Chart:

o p e r a t i n g t h e a n a l y z e r

Levey-Jennings charts plot the measured quality control results for each day. The calculated mean value is shown by the solid, vertical center line. The +/- 2 SD values are shown by the dashed lines. The limits of the charts are the mean +/- 4 SD. The Levey-Jennings charts plot data for the last 31 days. (See example below.)

LOT#

2SD

7.44

The statistics reported above each chart require a minimum of 5 stored quality control results. The maximum number of stored results is 93 for each level.

Page 44

o p e r a t i n g t h e a n a l y z e r

Random Errors

An isolated result which falls outside the +/- 3 SD control limits is classified as a random error. When a single random error occurs, disregard the result. When there is an increase in the frequency of random errors, the quality control sampling technique should be reviewed.

Systematic Errors

A recurring measurable deviation from the mean is classified as a systematic error. One example of a systematic error is when a progressive increase or decrease in control results is noted. Possible causes are:

• aging or protein contaminated electrode

• bubbles beneath an electrode membrane

• a change in calibrant

• a change in temperature

• a change in quality control material

• aging reference electrode

If the sampling technique is acceptable and random errors continue, refer to ELECTRODES in Troubleshooting.

Page 45

o p e r a t i n g t h e a n a l y z e r

Users should follow applicable agency requirements for quality control testing.

Recommended Material

EasyQC Quality Controls:

Level 1 Level 2 Level 3

Hct Level 1 Hct Level 2

Do not use perfluorocarbon-based control materials on the EasyStat analyzer. This type of control material will damage the electrodes.

Precautions

Refer to the package insert provided with the quality control material.

Recommended Procedure

Run all control levels each day the analyzer is in use. future statistical analysis.

Data is stored for

Use Instructions

Refer to the package insert provided with the quality control material.

Storage and Stability

Refer to the package insert provided with the quality control material.

Handling

Refer to the package insert provided with the quality control material.

Expected Results

Refer to the package insert provided with the quality control material.

Page 46

HOME MENU

ANALYZE SAMPLE

2 ANALYZE QC

3 CALIBRATE

4 DAILY CLEANER

5 SECOND MENU

DAILY CLEANER

LIFT SAMPLER TO

USE CLEANER

o p e r a t i n g t h e a n a l y z e r

Daily Cleaner

Probe

The fluid path must be cleaned with daily cleaning solution to remove protein deposits. The analyzer will display CLEANER REQUIRED if more than 10 samples have been analyzed and more than 24 hours have elapsed since the last cleaning cycle.

Daily Cleaner

Select DAILY CLEANER. The display shows LIFT SAMPLER TO USE CLEANER. The sampler must be in the syringe mode position. Lift the sampler until PROBE IN CLEANER? appears. Insert the probe into the cleaning solution and press YES to aspirate. Hold the container in place until REMOVE CLEANER RETURN SAMPLER is displayed.

Push the sampler down into the closed position. The cleaning cycle is followed by an automatic two-point calibration to prepare the analyzer for sample analysis. LIFT SAMPLER TO ANALYZE pH PCO2 PO2 Hct Na+ K+ Ca++ is displayed when calibration is successful.

sCa

is replaced with Cl- when Cl- mode is selected.

Page 47

o p e r a t i n g t h e a n a l y z e r

When CLEANER REQUIRED is displayed, a cleaning cycle must be completed before calibration or sample analysis is permitted. Performing a cleaning cycle is the only daily maintenance required, and is essential to promote trouble-free analyzer operation.

As preventive maintenance or when a PCO replaced, a more aggressive cleaning procedure can be performed to remove accumulated protein within the sampler and preheater. The frequency of this procedure is dependent on the number and quality (high protein concentrations) of patient samples run. This procedure can be performed infrequently (once every 6 months) or as frequently as once per month. Each laboratory should establish their own preventative maintenance program. To perform this preventative maintenance, refer to the Sample probe/sensor module obstructions procedure found under FLOW in Troubleshooting.

or PO2 electrode is being

Page 48

o p e r a t i n g t h e a n a l y z e r

Second Menu

HOME MENU

1 ANALYZE SAMPLE 2 ANALYZE QC 3 CALIBRATE 4 DAILY CLEANER 5 SECOND MENU

SECOND MENU

1 STANDBY 2 REPLACE COMPONENTS 3 DIAGNOSTICS 4 STORED INFORMATION 5 SETUP MENU 6 ADJUST DISPLAY

Default off

MANUAL STANDBY

CONFIRM?

REPLACE COMPONENTS

1 REAGENT MODULE 2 ELECTRODES 3 PUMP TUBING 4 SENSOR MODULE/SAMPLER 5 VALVE MODULE 6 SWITCH TO Ca++/Cl

DIAGNOSTICS

1 TEST COMPONENTS 2 TEST FLUIDICS 3 SENSOR STATUS 4 PRIME FLUIDS 5 PRINTOUTS

STORED INFORMATION

1 PATIENT RESULTS 2 QC RESULTS 3 REFERENCE LIMITS 4 CAL/SAMPLE # 5 REAGENT MODULE 6 PRINTOUTS

SECURITY CODE

* * * *

CONFIRM?

ADJUST DISPLAY

1 BRIGHTNESS 2 BRIGHTNESS 3 REVERSE

↑ ↓

SETUP MENU

1 USER OPTIONS 2 CONFIGURATION 3 PRINTER OPTIONS 4 SET REFERENCE LIMITS 5 PATIENT INFORMATION 6 DELETE DATA

Page 49

STANDBY

yes

STANDBY IN 1 MIN

SECOND MEN

STANDBY

2 REPLACE COMPONENTS

3 DIAGNOSTICS

4 STORED INFORMATION

5 SETUP MENU

6 ADJUST DISPLAY

MANUAL STANDBY

o p e r a t i n g t h e a n a l y z e r

Standby

Standby is activated manually or automatically to conserve fluids during long periods of inactivity. When in STANDBY, the analyzer discontinues automatic calibrations. The sensor module remains at

37.0°C, the valve module remains at 39.0°C, and fluid maintenance is performed.

Manual Activation

Select STANDBY from the SECOND MENU. The display reads MANUAL STANDBY CONFIRM?. Press YES to CONFIRM?.

The display will read STANDBY IN 1 MIN. If NO is pressed, Standby is cancelled.

Automatic Activation

Turn AUTO STANDBY ON under CONFIGURATION in the SETUP MENU. The analyzer will enter STANDBY at the next

scheduled calibration if no patient or quality control samples have been analyzed since the last calibration.

During Standby, the display reads STANDBY or STANDBY NOT CALIBRATED. When STANDBY NOT CALIBRATED is displayed, a calibration is required before sample analysis, after deactivating Standby. When STANDBY is displayed, the analyzer remains calibrated and sample analyses can be performed after deactivating Standby.

CONFIRM

Deactivation

From the STANDBY or STANDBY NOT CALIBRATED display, press NO or to deactivate Standby. Press NO to continue Standby. Once Standby is deactivated, the HOME MENU is displayed. If ANALYZE SAMPLE is displayed in the HOME MENU, sample analysis can be performed. If ANALYZE SAMPLE is not displayed, a calibration is required before sample analysis.

. STANDBY OFF? is displayed. Press YES

Page 50

o p e r a t i n g t h e a n a l y z e r

Replace Components

SECOND MENU

1 STANDBY 2 REPLACE COMPONENTS 3 DIAGNOSTICS 4 STORED INFORMATION 5 SETUP MENU 6 ADJUST DISPLAY

REPLACE COMPONENTS

1 REAGENT MODULE 2 ELECTRODES 3 PUMP TUBING 4 SENSOR MODULE/SAMPLER 5 VALVE MODULE 6 SWITCH TO Ca++/Cl

The EasyStat analyzer contains components which require periodic replacement. These components include the electrodes (pH, PCO

, Na+, K+, Ca

replacement schedule below must be followed to properly maintain the EasyStat analyzer.

It is recommended that quality control material be analyzed after

component replacement to verify performance.

, Cl-, and Reference) and reagent module. The

Cl- MODE?

yes

PATIENT RESULTS

WILL BE LOST

CONFIRM?

yes

RESTART THE ANALYZER.

Switch to Ca++/Cl-, select SWITCH TO Ca++/Cl-. The display will show either Cl- MODE (if the analyzer is currently in Ca++) or Ca++ MODE (if the analyzer is currently in Cl- mode). Press YES to move to next screen. Then press YES to confirm. PATI ENT RESULTS WILL BE LOST. All the stored information will be erased. The analyzer will restart in the selected mode. Replace the correct electrode for the selected mode. Follow the instructions in this chapter to operate the analyzer.

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PUMP TUBING Replace every 6 months

VALVE MODULE Replace as required

SENSOR MODULE Replace as required

SAMPLER Replace as required

pH ELECTRODE Replace as required

PCO

ELECTRODE Replace as required

Na+ ELECTRODE Replace as required

K+ ELECTRODE Replace as required

Ca++ ELECTRODE Replace as required

Cl- ELECTRODE Replace as required

REFERENCE ELECTRODE Replace every 6 months

REAGENT MODULE Replace when empty or expired

PRINTER PAPER Replace as required

PROBE WIPER Replace every 3 months

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To replace EasyStat components, first select REPLACE COMPONENTS from the SECOND MENU, then proceed with

component replacement as described in this section. If any replacement procedure exceeds 20 minutes, the analyzer beeps and NEED MORE TIME? is displayed. Press YES to return to the previous screen. When all replacements are complete, press the to return to the HOME MENU.

After any component replacement procedure, the WARMING UP message may appear for up to 30 minutes. During this time, the EasyStat will not calibrate or analyze samples.

Failure to select the proper component from the REPLACE

COMPONENTS menu could result in multiple reliability issues, including flow problems and/or slope, noise or drift errors.

HOME key

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Reagent Module

If the EasyStat displays RGNT MODULE EMPTY or RGNT MODULE EXPIRED, it is necessary to install a new reagent module. Select REAGENT MODULE from the REPLACE COMPONENTS menu. Fluid is automatically purged from the sample path. The display prompts you to REMOVE REAGENT MODULE. Open the access door. Push in the reagent module release

lever while holding the reagent module on the left side. Pull the module to the left. When the guide arrow points to the edge of the reagent module, pull the module straight out from the front of the analyzer.

564

231

yes

564

120

yes

Used reagent module contains biohazardous waste.

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Prior to installation, a reagent module must be stored at room temper-

ature for a minimum of four hours. When the center of the indicator on the back of the reagent module becomes dark, the module has been exposed to excessive temperature and must not be used.

Place the new reagent module into the front of the analyzer. The guide arrow must point to the right side of the reagent module. Push the module straight back, then firmly to the right to lock it into place against the valve module. Press YES to REPLACEMENT COMPLETED?. The reagents are automatically primed from the reagent module. When priming is complete, the display indicates the detection of each fluid with PASS, then automatically returns to the REPLACE COMPONENTS screen.

The reagent module contains encoded information which is read by the analyzer upon installation of the reagent module. This information includes: reagent pH, PCO ues, and install by date of the reagent module.

, PO2, Hct, Na+, K+, Ca++, and Cl- val-

Electrodes

The best indicator that an electrode (pH, PCO2, PO2, Na+, K+, Ca++, Cl- or reference) requires replacement is when the EasyStat displays SLOPE ↑/↓ , mV OUT OF RANGE or DRIFT for a single electrode. These messages generally indicate that the electrode is not functioning correctly. For detailed information, refer to the Troubleshooting chapter of this manual.

To remove or replace an electrode, select ELECTRODES from the REPLACE COMPONENTS menu. Fluid is automatically purged from the sample flow path. When the purge cycle is complete, REPLACEMENT COMPLETED? is displayed. Proceed with electrode replacement.

Failure to select the proper component from the REPLACE COMPONENTS menu could result in multiple reliability issues, including flow problems and/or slope, noise or drift errors.

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To remove an electrode, push the compression plate down until latch locks into the open position.

Grip the desired electrode handle, squeeze, and pull it straight out from the sensor module.

To install a new electrode, push the electrode into its designated position. The handle snaps into the sensor module. Each electrode is keyed to assure correct placement. DO NOT FORCE. Refer to the illustration and the access door label for correct electrode order and location.

the

Release the compression plate to compress the electrodes within the sensor module.

Press YES to REPLACEMENT COMPLETED?. Reagents are automatically primed from the reagent module. When priming is complete, the display indicates the detection of each fluid with PASS, then automatically returns to the REPLACE COMPONENTS screen.

A WARMING UP message may appear for up to 30 minutes. During this time, the EasyStat will not calibrate or analyze samples.

CAL FREQUENCY in the CONFIGURATION section of the SETUP MENU.

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Pump Tubing

Replace the pump tubing every six months, or earlier if the pump tubing appears worn or flattened. Select PUMP TUBING. Fluid is automatically purged from the sample flow path. When the purge cycle is complete, proceed with pump tubing replacement.

Remove the pump tubing.

Install the new pump tubing.

Push the two middle collars completely into the back of the slots on the pump shelf.

Press YES to REPLACEMENT COMPLETED? Reagents are automatically primed from the reagent module. When priming is complete, the display indicates the detection of each fluid with PASS, then automatically returns to the REPLACE COMPONENTS screen.

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Probe Wiper Replacement

Probe wipers should be changed every 3 months. In some cases they may last longer, as the frequency of probe wiper replacement depends on the number and type of samples analyzed. If the motion of the sampler becomes difficult, wipe the probe with an oil wipe (provided in the probe wiper replacement kit). If the sampler’s motion continues to be difficult, the probe wiper may need replacement.

Raise the sampler to the capillary sample position.

Using the tool supplied in the probe wiper replacement kit, turn the probe wiper 90° to unlock. This will align the notches on the probe wiper with the notch on the sampler.

Use the tool to pry the used probe wiper from the sampler.

Push the sampler down into the closed position, then raise the sampler to the sample container mode. Wipe the probe with an oil wipe (provided in the probe wiper replacement kit).

Insert the new probe wiper with the notches aligned. With the tool, turn the probe wiper 90° into the locked position. Lower and raise the probe into the sample container mode several times to verify proper probe motion.

yes

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Sensor Module/Sampler

Sensor module or sampler replacement should be infrequent. Sensor Module replacement will be necessary only if certain display messages become chronic (refer to SENSOR MODULE in Troubleshooting). Sampler replacement is necessary if the sample probe is bent, damaged or obstructed (refer to FLOW in Troubleshooting), or if the sampler movement is defective.

Select SENSOR MODULE/SAMPLER. Fluid is automatically purged from the sample flow path. When the purge cycle is complete, proceed with sensor module and/or sampler replacement.

To remove the sensor module from the analyzer, first remove the pump tubing.

Disengage the sampler by slightly lifting the sampler until it unlocks from the valve module.

lightly Lift ampler

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Pull the release lever and the sensor module is disengaged.

Remove from the analyzer.

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Sampler Removal

To remove the sampler from the sensor module, place the sensor module on its side with the sampler side up. Using a coin or fingers, remove the retaining screw from the sensor module. Remove the screw mount (includes spring).

Rotate the sampler into the capillary mode position, then pull it out of the sensor module.

Installation

Install the new sampler (includes sample probe and wiper) in the sensor module. Insert the sampler alignment pin into the sensor module. Rotate the sampler into the closed position.

Install the screw mount (includes spring) into the sampler. Replace the retaining screw and tighten. DO NOT over tighten.

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After installing a new sampler, reinstall the complete sensor module. Lift the sampler up slightly. Place the sensor module on the alignment pin and, using your thumb, push it straight back into position.

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Reconnect the pump tubing to the valve module and sensor module. Push the sampler down into the closed position.

A WARMING UP message may appear for up to 30 minutes.

During this time, the EasyStat will not calibrate or analyze samples.

If the sampler was replaced, the sampler switches may be checked for proper function. Select the SAMPLER SWITCHES test outlined under Diagnostics in Operating the Analyzer.

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Valve Module

Valve Module replacement is necessary when VALVE ERROR or VALVE TEMPERATURE error messages become chronic (refer

to VALVE MODULE in Troubleshooting).

To remove or replace the valve module, select VALVE MODULE.

Fluid is automatically purged from the sample path. REMOVE REAGENT MODULE is displayed. Remove the reagent module. PURGE WITH AIR, READY? is displayed. Connect the tub-

ing from the troubleshooting kit to the valve module waste port with the open end placed into a waste receptacle. Press YES. Calibrant A, Calibrant B and Calibrant C are automatically purged from the valve module. When the purge cycle is complete, REPLACEMENT COMPLETED? is displayed. Proceed with valve module replacement.

Remove the pump tubing.

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Disengage the sampler by slightly lifting the sampler until it unlocks from the valve module.

lightly Lift ampler

Pull the release lever and the sensor module is disengaged.

Remove from the analyzer.

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Remove the valve module by pulling it straight out.

o p e r a t i n g t h e a n a l y z e r

To install a new valve module, place the valve module onto the alignment pin and push straight back.

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Reinstall the sensor module. Place the sensor module on the alignment pin and, using your thumb, push it straight back into position.

Reconnect the pump tubing to the valve module and sensor module. Push the sampler down into the closed position. Close the access door.

Reinstall the reagent module. Press YES to REPLACEMENT COMPLETED?. Reagents are automatically primed from the reagent module. When priming is complete, the display indicates the detection of each fluid with PASS, then automatically returns to the REPLACE COMPONENTS screen.

A WARMING UP message may appear for up to 30 minutes. During this time, the EasyStat will not calibrate or analyze samples.

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Compression Plate

Compression plate replacement is necessary when the latch, spring mechanism, or seal is damaged. Follow the previous instructions for electrode or sensor module replacement. To replace the compression plate, remove all the electrodes. This will ensure that all fluids are purged from the sample flow path.

Release the compression plate.

Grasp the compression plate and pull it out of the sensor module.

To install the compression plate, insert it into the sensor module. Make sure that the metal bar at the rear of the module is snapped inside the hinge tabs. Gently push down on the compression plate to engage the spring around the fluid path exit port. Reinstall the electrodes as described earlier in this section.

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Printer Paper

To install a new paper roll, cut the tape or adhesive off the beginning of the paper. Open the printer door. Push the paper lever up. Gently push the edge of the paper into the slot behind the printer. Push the paper lever down. The paper is automatically fed through the printer. The paper roll rests in the tray behind the printer. Close the printer door to protect the paper roll.

To advance the paper, press the

Operation of the printer without paper will damage the printer head. To operate the analyzer for extended periods without paper, the printer must be turned off. To turn the printer off, refer to PRINTER OPTIONS in the SETUP MENU.

button.

nter Door

Operation of the printer without Medica approved printer paper will result in the premature failure of the printer, voiding the warranty.

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Fuses

The EasyStat analyzer uses 250VAC fuses. When the voltage setting is 110V, 0.8 amp fuses must be installed. When set to 220V, 0.4 amp fuses must be installed. Correct fuses must be used with each voltage setting. To replace the fuse(s), remove the power cord, then push down on the fuse holder release tab and pull straight out.

The EasyStat analyzer will only accept slow blow or time delay fuses.

Remove the fuse(s) from the holder and insert the new fuse(s). Confirm that the fuse rating matches the voltage setting on the analyzer.

Reinstall the fuse holder, pushing in until it snaps into place. Connect the power cord.

Contact your EasyStat dealer when repeated fuse replacement is required.

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Analyzer Surface Cleaning/Storage/Moving

When complete chassis cleaning or analyzer storage is necessary, select VALVE MODULE from the menu. When the purge cycle is complete, remove the reagent module. PURGE WITH AIR, READY? is displayed. Connect the troubleshooting kit tubing to the valve module waste port with the open end placed into a waste receptacle. Press YES. Calibrant A, Calibrant B and Calibrant C are purged from the valve and sensor modules. Remove the electrodes, sensor module, valve module and pump tube from the analyzer.

Clean the analyzer with a 10% bleach (0.4-0.6% NaClO) solution. Apply the solution to a cloth to wipe down all outside surfaces.

REPLACE COMPONENTS

DO NOT use solvents (examples: methyl alcohol, ethyl alcohol, isopropyl alcohol) or cleaning agents containing benzalkonium chloride.

Failureto purge the flow path of air prior to storage could result in severe damage to the sensor and valve modules.

Clean the sample port of the sampler. Clean all valve module surfaces. DO NOT run bleach solution through the sample path.

Reinstall the valve module and sensor module. The analyzer can now be stored or moved. The pump tube, reagent module, electrodes, and power cord should be stored separately.

To resume operation, insert the power cord and install the electrodes, pump tube and reagent module.

A WARMING UP message may appear for up to 30 minutes. During this time, the EasyStat will not calibrate or analyze samples.

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Diagnostics

SECOND MENU

STANDBY

2 REPLACE COMPONENTS

3 DIAGNOSTICS

4 STORED INFORMATION

5 SETUP MENU

6 ADJUST DISPLAY

DIAGNOSTIC

TEST COMPONENTS

2 TEST FLUIDICS

3 SENSOR STATUS

4 PRIME FLUIDS

5 PRINT mV

TEST COMPONENTS

PUMP

2 VALVE

3 SAMPLER SWITCHES

4 DOOR SWITCH

5 REAGENT READER

TEST FLUIDICS

REAGENT FLOW

2 SAMPLE FLOW

3 BUBBLE DETECTOR CAL

4 PUMP CAL

SENSOR STATUS

ELECTRODE mV

2 BAROMETRIC PRESSURE

3 TEMPERATURE

PRIME FLUIDS

PRINT mV

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The tests and data in this section are available to examine the function and status of individual EasyStat components and fluidics. To identify component defects or fluidic problems, refer to the Troubleshooting chapter in this manual.

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TEST COMPONENTS

Select TEST COMPONENTS to test the operating status of the pump, valve, sampler switches, door switch and reagent reader.

PUMP

Select PUMP to verify pump function. The screen displays ROTATING..., then FULL ROTATION?. Look for pump

rotation. When full pump rotation occurs, press YES and PASS is displayed.

When there is no pump movement or partial pump movement, press NO and FAIL is displayed. Remove the pump tubing and repeat the PUMP test. If the test passes, install a new pump tubing, calibrate the analyzer and resume operation. If the test fails, contact your EasyStat dealer.

VALVE

Select VALVE to verify valve function. The screen displays ROTATING..., then FULL ROTATION?. Look for rotation

of the valve knob. When full valve knob rotation occurs, press YES and TESTING... is displayed. Internal testing verifies correct valve positioning for the Calibrant A, Calibrant B, Rinse, Air and Home positions. At test completion, PASS or FAIL is displayed.

When there is no valve knob movement or partial valve knob movement, press NO and FAIL is displayed. Repeat the VALVE test. If the test fails again, the valve may have an obstruction. Refer to VALVE MODULE in Troubleshooting and follow the instructions for valve module obstructions.

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SAMPLER SWITCHES

Select SAMPLER SWITCHES to verify the sampler positioning sensor and the sample mode switch.

CAPILLARY MODE? is displayed. Lift the sampler to the capillary mode and press YES.

SAMPLER CLOSED? is displayed. Push the sampler down into the closed position.

SYRINGE MODE? is displayed. Lift the sampler to the syringe mode and press YES.

RETURN SAMPLER is displayed. Push the sampler down into the closed position. POSITION PASS or FAIL and

MODE PASS or FAIL are displayed. When the SAMPLER SWITCHES test fails, refer to SENSOR MODULE in Troubleshooting.

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DOOR SWITCH

Select DOOR SWITCH to verify access door switch function. When DOOR OPEN? is displayed, open the access door and press YES.

When DOOR CLOSED? is displayed, close the access door and press YES. The screen displays PASS or FAIL. When the test fails, refer to SENSOR MODULE in Troubleshooting for further instructions.

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REAGENT READER

Select REAGENT READER to verify reagent reader function. REAGENT MODULE REMOVED? is displayed. Remove the reagent module and press YES. REAGENT MODULE INSTALLED? is displayed. Reinstall the same reagent module and press YES. PASS or FAIL is displayed.

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If the above test fails, remove the reagent module and clean the metal contacts on the analyzer with a damp cloth. Then dry the contacts thoroughly. Repeat the REAGENT READER test. If it fails again, contact your EasyStat dealer.

Prior to installation, a reagent module must be stored at room temperature for a minimum of four hours.

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Test Fluidics

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The sampler must be in the closed position for the following tests.

TEST FLUIDICS

Select TEST FLUIDICS to test the operating status of the reagent flow, sample flow, bubble detector and pump calibration.

REAGENT FLOW

Select REAGENT FLOW to verify the flow of Calibrant B, Calibrant A, and Calibrant C. When testing is complete,

CALIBRANT B PASS or FAIL, CALIBRANT A PASS or FAIL and CALIBRANT C PASS or FAIL is

displayed. When the test fails, refer to FLOW in Troubleshooting for further instructions.

SAMPLE FLOW

Select SAMPLE FLOW to verify the flow of the sample path. During testing, the screen will display LIFT SAMPLER TO TEST SAMPLE FLOW. Lift the Sampler in the Syringe Mode until PROBE IN TEST DYE? is displayed. Place the probe in the test dye and press YES. Hold the test dye in place, keeping the probe submerged in the test dye until REMOVE TEST DYE RETURN SAMPLER is displayed. Push the Sampler down in to the closed position. Testing will automatically occur. When testing is complete, SAMPLE FLOW PASS or SAMPLE FLOW FAIL is displayed. When the test fails, refer to FLOW in Troubleshooting for further instructions.

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BUBBLE DETECTOR CAL

Select BUBBLE DETECTOR CAL to verify proper air and fluid detection. During testing, the screen will display BUBBLE CAL. When testing is complete, BD PASS or BD FAIL is displayed with readings for both air and fluid. The difference between the air and fluid readings must be greater than or equal to 60 for the bubble detector. In the event of a failure, refer to FLOW in Troubleshooting for further instructions.

PUMP CAL

Select PUMP CAL to verify proper pump calibration. The pump calibration counts the number of steps required to move fluid from the valve module to the bubble detector. The screen displays PUMP CAL. When testing is complete, PASS or FAIL is displayed with the number of pumping steps for each test. The number of steps must be between 460 and 900 for the first value. Refer to FLOW in Troubleshooting for further instructions.

SENSOR STATUS

Select SENSOR STATUS to view the electrode millivolts, the measured barometric pressure, or the sensor, valve, and room temperatures.

ELECTRODE mV's

Select ELECTRODE mV’s to view the electrode millivolt readings for Calibrant A, Calibrant B or Calibrant C.

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BAROMETRIC PRESSURE

Select BAROMETRIC PRESSURE to view the barometric pressure. When the displayed barometric pressure does not match a reference barometer, set the analyzer’s barometric pressure by proceeding to the SETUP MENU and selecting USER OPTIONS, then BAROMETRIC PRESSURE.

Caution: The barometer is calibrated at the factory. The barometric pressure setting should only be changed to correlate it to a local reference barometer. The proper operation of the analyzer depends on a correct barometric pressure setting.

TEMPERATURE

Select TEMPERATURE to view the sensor, valve and room temperatures. The readings must be between:

Sensor 36.9° to 37.1°C

Valve 36.0° to 41.0°C

Room 15° to 30°C

If any temperature is not within range, refer to the Troubleshooting chapter in this manual.

PRIME FLUIDS

Prime the fluid path by pumping Calibrant B, Calibrant A and Calibrant C from the reagent module.

PRINT mV,S

Select PRINT mV,S to display and print millivolt readings for each parameter. This feature is useful when reporting problems to your EasyStat distributor.

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Stored Information

SECOND MENU

1 STANDBY 2 REPLACE COMPONENTS 3 DIAGNOSTICS 4 STORED INFORMATION 5 SETUP MENU 6 ADJUST DISPLAY

STORED INFORMATION

1 PATIENT RESULTS 2 QC RESULTS 3 REFERENCE LIMITS 4 CAL/SAMPLE # DATA 5 REAGENT MODULE 6 PRINTOUTS

PATIENT RESULTS

1 LAST

2 ALL 3 ENTER ID#

QC RESULTS

1 LAST CONTROL

2 PRINT QC STATS 3 PRINT QC RESULTS 4 PLOT QC CHARTS 5 FAILED QC

QC REFERENCE LIMITS

1 LEVEL 1

2 LEVEL 2 3 LEVEL 3 4 Hct LEVELS

CAL/SAMPLE # DATA

1 SLOPES 2 mV’s 3 PUMP/BUBBLE DETECTOR 4 SAMPLE COUNTER

REAGENT MODULE

1 STATUS 2 CONCENTRATIONS

PRINTOUTS

1 USER OPTIONS

2 CONFIGURATION 3 PRINTER OPTIONS 4 PATIENT LIMITS 5 QC LIMITS 6 PATIENT INFORMATION

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Select STORED INFORMATION from the SECOND MENU to obtain stored information on patient and quality control results, as well as view the reference limits, calibration, and reagent module information.

PATIENT RESULTS

View or print stored patient results. Up to 64 results are stored.

LAST

View and print the last patient’s measured results.

ALL

Print all patient results.

ENTER ID#

Print the measured results for a specific patient using the keypad or barcode reader.

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QC RESULTS

View the last quality control results, print quality control statistics, and plot quality control charts.

LAST CONTROL

View the results for the last control samples. Choose from QC Level 1, QC Level 2, QC Level 3, Hct Level 1 or Hct Level 2.

PRINT QC STATS

Print the statistics for stored quality control data by level.Printing can be cancelled by pressing NO.

PRINT QC RESULTS

Print the results for stored quality control data by level. Printing can be cancelled by pressing NO.

PLOT QC CHARTS

Print Levey-Jennings charts using stored quality control statistics. Plot three quality control levels for each measured parameter or plot all charts. Printing can be cancelled by pressing NO.

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REFERENCE LIMITS

View the limits for quality control, normal, critical and AMR limits.

QC LEVEL 1,2 or 3, Hct Level 1 or 2

View the current quality control reference limits set for each control level.

NORMAL

View the analyzer’s normal limits for arterial1, mixed venous3, or

venous

samples. The preset limits are:

Arterial Mixed Venous Venous pH 7.350-7.450 7.340-7.360 7.340-7.360 PCO2 35.0-45.0 mmHg 44.0-46.0 mmHg 44.0-46.0 mmHg PO2 83-108 mmHg 38-42 mmHg 38-42 mmHg Hct 35-50% 35-50% 35-50% Na+ 136.0-146.0 mmol/L 136.0-146.0 mmol/L 136.0-146.0 mmol/L K+ 3.5-5.1 mmol/L 3.5-5.1 mmol/L 3.5-5.1 mmol/L Ca++ 1.05-1.32 mmol/L 1.05-1.32 mmol/L 1.05-1.32 mmol/L Cl- 98.0–106.0 mmol/L 98.0–106.0 mmol/L 98.0–106.0 mmol/L

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CRITICAL

View the analyzer’s critical limits for arterial2, mixed venous3, or

venous

samples. These limits have been set to be equal to normal limits. The lab should determine and set their own critical limits which are consistent with the site of venous sampling and other clinical factors. The preset limits are:

Arterial Mixed Venous Venous pH <7.300, >7.600 <7.340, >7.360 <7.340, >7.360 PCO2 <20.0, >50.0 mmHg <44.0, >46.0 mmHg <44.0, >46.0 mmHg PO2 <45, >250 mmHg <38, >42 mmHg <38, >42 mmHg Hct <25, >70% <25, >70% <25, >70% Na+ <115.0, >150.0 mmol/L <115.0, >150.0 mmol/L <115.0, >150.0 mmol/L K+ <3.0, >7.5 mmol/L <3.0, >7.5 mmol/L <3.0, >7.5 mmol/L Ca++ <0.8, >3.0 mmol/L <0.8, >3.0 mmol/L <0.8, >3.0 mmol/L Cl- <90.0, >112.0 mmol/L <90.0, >112.0 mmol/L <90.0, >112.0 mmol/L

Proceed to SETUP MENU and select SET REFERENCE

LIMITS to enter new values.

AMR

AMR is available when the feature is turned on in

CONFIGURATIONS. View the analyzer limits for each electrode.

CAL/SAMPLE # DATA

View the slopes and millivolts for each electrode, and the calibration status for the pump and bubble detectors.

Tietz: Fundamentals of Clinical Chemistry, 4th edition, (1996)

B. Statland: Clinical Decision Levels for Lab Test, 2nd edition

Fink: Clinical Practice in Respiratory Care

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SLOPES

View the slope and calibration status for each electrode (PASS, FAIL or INVALID). Anelectrode with a PASS status indicates

the last calibration was successful and the electrode is currently calibrated. A FAIL status indicates that an error occurred during the last calibration. INVALID indicates that the calibration status has become invalid after the calibration; for example, the reagent module has expired.

The acceptable slope ranges are:

pH 55.00 - 65.00 PCO PO

46.50 - 60.00

1.00 - 5.00 Hct 13.00 - 22.00 Na

52.00 - 64.00 K+ 52.00 - 64.00 Ca++ 20.00 - 34.00 Cl- 43.00 - 59.00

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mV’s

View the Calibrant A, Calibrant B and Calibrant C mV’s for each electrode.

PUMP/BUBBLE DETECTOR

View the calibration status and values for the pump, and the calibration status for the bubble detectors, giving the air and fluid readings for both.

SAMPLE COUNTER

Number of samples that have been performed on analyzer.

REAGENT MODULE

Verify the status and the concentrations of the reagents in the reagent module.

STATUS

View the current reagent module serial number and installation date; the EasyStat analyzer serial number on which the reagent module was first installed; and the reagent volume (%) remaining with the number of days remaining before calibrants expire.

CONCENTRATIONS

View the calibrant concentration for Calibrant A, Calibrant B, and Calibrant C for each parameter.

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PRINTOUTS

Print the settings for User Options, Configuration, Patient Limits, QC Limits, and Patient Information.

USER OPTIONS

Print the User Options settings.

CONFIGURATION

Print the Configuration settings.

PRINTER OPTIONS

Print the Printer Options settings.

PATIENT LIMITS

Print the normal and critical patient reference limits.

QC LIMITS

Print the quality control reference limits by level for both controls.

PATIENT INFORMATION

Print the patient information settings.

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o p e r a t i n g t h e a n a l y z e r

Setup Menu

CONFIGURATION 1/2

1 PO2 / PCO2 / BP mmHg

+ / K+

2 Na 3 Hct % 4 Hb 5 BC CHECKSUM OFF

/ Ca

mmol/L

CONFIRM ?

g/dL

REFERENCE LIMITS

1 QC 2 NORMAL 3 CRITICAL 4 AMR

CONFIGURATION 2/2

1 CAL FREQUENCY 8 HRS 2 AUTO STANDBY OFF 3 TEMPERATURE C 4 Rili-BAK OFF 5 AMR OFF

CONFIRM ?

sCa

is replaced with Cl- when Cl- mode is selected.

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o p e r a t i n g t h e a n a l y z e r

Select SETUP MENU from the SECOND MENU to set the functional parameters of the EasyStat analyzer.

Enter the security code if SECURITY CODE is turned ON under USER OPTIONS. Turning the SECURITY CODE ON prevents unauthorized personnel from entering and changing the

SETUP MENU.

USER OPTIONS

Set:

DATE/TIME, LANGUAGE, CORRELATION, REPORTED PATIENT DATA, BAROMETRIC PRESSURE, SECURITY CODE

Make sure you remove the reagent Module when changing the

DATE/TIME.

DATE/TIME

Set the month, day, year and time (expressed as a 24 hour clock). Press NO to edit the current date and time. The cursor appears beneath the month. Each time NO is pressed, the month changes. When the correct month appears, press YES and the cursor moves to the day. Enter the correct day by pressing the number keys. Press YES to proceed to the year and time. Press NO to correct the previous entry and YES to advance. When all entries are confirmed, the display returns to USER OPTIONS.

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CORRELATION

SET PARAMETERS

2 APPLY CORRELATION

APPLY CORRELATION

PATIENT RESULTS OFF

2 QC RESULTS

OFF

CONFIRM?

o p e r a t i n g t h e a n a l y z e r

LANGUAGE

Select the language by pressing the number keys. Press YES to

CONFIRM?.

CORRELATION

The analyzer can be set to correlate with or match the results of another analyzer. To correlate the EasyStat analyzer to a reference analyzer, data must first be collected from samples run on both analyzers. The correlation values can be applied to patient and quality control results.

First, analyze a minimum of 10 patient samples in each of the low abnormal, normal, and high abnormal ranges for each of the analytes.

Each patient sample must be run on both analyzers. The EasyStat correlation equations must be set with the default (1.00x + 0.0) coefficients when analyzing the samples.

Next, determine the correlation factors by performing a regression analysis of the data. The EasyStat data must be the “x” data, and the reference analyzer must be the “y” data. The regression slope is entered as the correlation slope, and the regression intercept is entered as the intercept.

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o p e r a t i n g t h e a n a l y z e r

Next, select CORRELATION, then SET PARAMETERS to view the stored correlation equations. To change any of these values, press NO to CONFIRM?, and enter any new correlation slopes and/or intercepts for each analyte. The cursor highlights the selection. Press the number keys to set the slope and intercept, and press YES to confirm the correct individual values. Press NO to change “+” to “-”, then press YES.

When entries are complete, press YES and CONFIRM? is displayed. To correct mistakes, press NO to return to the top of the list, and re-enter numbers. Press YES to confirm your entries. The pH,

, PO2, Hct, Na+, K+, Ca++ and Cl- slope input range is 0.90 to

PCO

1.10. The acceptable intercept input range for pH is -0.020 to 0.020, PCO2 is +/-5 mmHg and PO2 is +/-10 mmHg, Na+ is +/-10 mM, K+ is +/- 0.6 mM, Ca++ is +/- 0.6 mM, Cl- is ± 10 mM, and Hct is +/- 4%. The default values are: slope =1.00 and intercept = 0.00.

Finally, analyze patient samples on each analyzer to confirm the correlation. Correlation values can be applied to patient and/or quality control results. Correlation is not applied to normal, critical, or quality control ranges.

CORRELATION 1/2

SET PARAMETERS

SLOPE INTERCEPT

pH = X.XX X+X.XXXX

= X.XXX+ X.X mmHg

PCO

= X.XXX+ X mmHg

CONFIRM?

CORRELATION 2/2

SET PARAMETERS

SLOPE INTERCEPT

Hct = X.XXX+ X%

= X.XXX+ X.Xmmol/L

= X.XXX+ X.XX

= X.XXX+ X.XXmmol/L

CONFIRM?

mmol/L

Using correlations does not change the measurement range, only the displayed range. The following is a detailed example for pH. The measurement range is 6.500 to 8.000. If the pH correlation is 1.00x + 0.020, the display range is: 1.00 (6.500) + 0.020 to 1.00 (8.000) + 0.020 or 6.520 to 8.020. Using this example, if a sample had a measured pH less than 6.500, the result would be reported as < 6.52↓↓.

sCa

is replaced with Cl- when Cl- mode is selected.

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o p e r a t i n g t h e a n a l y z e r

REPORTED PATIENT DATA

Select ANALYTES, then REPORTED DATA to enable or disable the reporting of specific analytes. A calibration is required after analytes are turned on or off under REPORTED DATA.

Select

CALCULATED VALUES

to enable or disable the

reporting of specific calculated values.

BAROMETRIC PRESSURE

View or set the measured barometric pressure. The barometric pressure is measured using a factory calibrated electronic sensor. When the displayed barometric pressure matches a reference barometer, press YES to CONFIRM?. When it does not match a reference barometer, press NO. Press the number keys to enter the actual barometric pressure. Press YES when the entry is complete. If the barometric pressure does not change, verify the accuracy of the reference barometer. When the error remains, contact your EasyStat dealer.

SECURITY CODE

To activate this feature, press YES when SECURITY ON? is displayed.

Enter up to a four digit code and press YES to CONFIRM?. The SETUP MENU is displayed. The security code will be required in the future for access to the SETUP MENU.

To turn the security code off, press YES when SECURITY OFF? is displayed. Answering NO to SECURITY OFF? will require entering the security code in the future for access to the SETUP MENU.

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o p e r a t i n g t h e a n a l y z e r

CONFIGURATION

Select CONFIGURATION to set analyzer options. Select from: PO2/PCO2/BP, Na+/K+/Ca++, Hct, Hb, CAL FREQUENCY, AUTO STANDBY, and TEMPERATURE.

PO2/PCO2/BP

Change the measurement units (select mmHg or SI units) for PO2, PCO2 and barometric pressure. Results for SI units are shown in KPa.

Na+/K+/Ca

or Cl

Change the measurement units (select mmol/L or mmEq/L units).

HCT

Change the measurement units (select % or V/V) for hematocrit.

Change the measurement units for Hb. Select mmol/L, g/L or g/dL.

BC Checksum

Turn the feature ON or OFF. When the feature is ON, the analyzer has the uses the last digit in the barcode to perform a barcode checksum calculation.

CONFIGURATION 1/2

1 PO2 / PCO2 / BP mmHg 2 Na 3 Hct % 4 Hb 5 BC CHECKSUM OFF

CONFIGURATION 2/2

1 CAL FREQUENCY 8 HRS 2 AUTO STANDBY OFF 3 TEMPERATURE C 4 Rili-BAK OFF 5 AMR OFF

/ K+ / Ca

CONFIRM ?

mmol/L

g/dL

CAL FREQUENCY

Press the number keys to select and change an option. Press YES to CONFIRM? all configuration settings.

Select the time interval between automatic two-point calibrations. Select from: 2 hours, 4 hours, 8 hours

sCa

is replaced with Cl- when Cl- mode is selected.

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o p e r a t i n g t h e a n a l y z e r

AUTO STANDBY

Select ON or OFF. When ON, the analyzer will enter standby automatically. Standby is available manually with either selection.

TEMPERATURE

Change the temperature unit. Select Fahrenheit (F) or Celsius (C).

RILIBAK

Turn RiliBAK ON or OFF to use the statistic-based method for performing QC analysis required in Germany.

AMR

Turn AMR (Adjustable Measurement Range) ON or OFF. When ON, the default values are the low and high instrument range for each parameter. The ranges can be changed to ranges within the default limits.

PRINTER OPTIONS

Select printing options.

PRINTER

Turn the printer ON or OFF. When the analyzer runs out of printer paper, turn the printer OFF to prevent damage to the mechanism.

CALC’ D VALUES

Turn printing of calculated values ON or OFF.

PRINTOUTS

Select up to four (4) sample printouts.

SET REFERENCE LIMITS

Select SET REFERENCE LIMITS to set the quality control limits for each level, and the normal and critical patient limits.

It is recommended that any stored quality control results be deleted prior to entering information for a new lot of quality control. Refer to DELETE DATA in the SETUP MENU.

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QC LEVEL 1, 2, 3, Hct

o p e r a t i n g t h e a n a l y z e r

Enter, by level, quality control lot numbers and set the minimum and maximum values for each parameter. Press the number keys to set the values. Press YES to confirm the individual values and move to the next parameter. When the limits are correct for a particular level, press YES to confirm and move to the next electrode. When NO is pressed as a response to CONFIRM?, entries can be corrected.

If RiliBAK is turned ON in CONFIGURATIONS, set the target and percent deviation for each parameter.

To enter quality control information using the barcode reader, EasyQC quality controls must be used.

To enter quality control information using the barcode reader, select QC LEVEL 1, 2, 3, Hct 1 or 2. LOT # is highlighted on the display. Using the barcode reader, scan in the lot number provided on the quality control insert sheet. Next, the parameter will be highlighted. Scan in the pH range (verify that the displayed range matches the insert sheet). Repeat for the remaining parameters. When all entries are complete, press YES to CONFIRM?. When NO is pressed as a response to CONFIRM?, the settings can be corrected. Repeat for each level of control. To proceed with quality control analysis, press

to return to HOME MENU.

Use the default limits as a guideline. Each laboratory should establish their own normal and critical limits. Press the number keys to select NORMAL or CRITICAL limits.

sCa

is replaced with Cl- when Cl- mode is selected.

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o p e r a t i n g t h e a n a l y z e r

NORMAL

Set the normal range for each parameter. Select arterial, mixed venous or venous. To change the ranges, press NO to CONFIRM?. Press the number keys to enter the desired limits, and YES to confirm each individual setting and advance to the next entry. When all limits are entered, press YES to CONFIRM? to accept all entries. When NO is pressed as a response to CONFIRM?, entries can be corrected.

When patient results fall within the normal range for the EasyStat analyzer, no arrows appear with the measured results. For example, when the normal pH range is 7.350 - 7.450, no flags are displayed/ printed for patient pH results greater than or equal to 7.350 and less than or equal to 7.450.

sCa

is replaced with Cl- when Cl- mode is selected.

Page 97

Na.0

150.0

mmol/L

Hct

SET REFERENCE LIMITS

CRITICAL

ARTERIAL

7.300

7.600

PCO220.0

PO260

250

CONFIRM?

SET REFERENCE LIMITS

CRITICAL

ARTERIAL

Ca++0.82

mmol/L

CONFIRM?

o p e r a t i n g t h e a n a l y z e r

CRITICAL

Set the critical ranges for each parameter. Select arterial, mixed venous, or venous. Press the number keys to enter the desired limits, and YES to confirm each individual setting and move to the next location. When all limits are entered, press YES to CONFIRM? to accept all entries. When NO is pressed as a response to CONFIRM?, entries can be corrected.

When analysis results are in the critical range, they are flagged as low (↓↓) or high (↑↑) on both the display and the printout. For example, when the critical pH limits are 7.300 and 7.600, a ↓↓ flag is displayed/printed for patient pH results less than or equal to 7.300 or a ↑↑ flag is displayed/printed for patient pH results greater than or equal to 7.600.

Patient results that are outside the normal range, and not within the critical range will be flagged as low (↓) or high (↑) on the display and printout.

-- 50.0mmH

-- 3.00

mmH

RILIBAK

Set the RiliBAK target, percent deviation and range for each parameter. To change the setting, press NO to CONFIRM?. Press the number keys to enter the desired limit and press YES to CONFIRM? to accept all entries. When NO is pressed as a response to

CONFIRM?, entries can be corrected.

AMR

Set the Adjustable Measurement Range for each parameter. To change the setting, press NO to CONFIRM?. Press the number keys to enter the desired limit and press YES to CONFIRM? to accept all entries. When NO is pressed as a response to CONFIRM?, entries can be corrected.

sCa

is replaced with Cl- when Cl- mode is selected.

REFERENCE LIMITS 1/6

Rili-BAK LEVEL 1

LOT #XXXXXXX

TARGET X.XXX mmHg DEVIATION X.XX % RILIBAK X.XXX

X.XXX mmHg

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PATIENT INFORMATION

PATIENT ID

OFF

2 PATIENT TEMP

OFF

3 Hb

OFF

4 FIO

OFF

5 TIME DRAWN

OFF

CONFIRM?

PATIENT INFORMATION

2/2

SAMPLE TYPE

OFF

2 SAMPLE SITE

3 OPERATOR ID

OFF

o p e r a t i n g t h e a n a l y z e r

PATIENT INFORMATION

Turn patient information options ON or OFF for all samples. The options are:

PATIENT ID, PATIENT TEMP Hb, FIO2, TIME DRAWN, SAMPLE TYPE, SAMPLE SITE, OPERATOR ID

Press the number keys to select and change an option. Press YES to CONFIRM?.

When any options are turned ON, the EasyStat displays ENTER PATIENT DATA? after sample aspiration. Press YES to enter patient information. Use the number keys to enter values, and press YES to advance to the next option. When all entries are correct, press YES to CONFIRM?.

When Hb is turned on under PATIENT INFORMATION, THb

is not displayed or printed as a calculated result.

When PATIENT ID is turned ON, a patient ID may be entered for each patient sample. A maximum of 14 digits is accepted. The barcode reader may be used to enter the patient ID.

When PATIENT TEMP, Hb and FIO2 are OFF, the default values (Patient Temp = 37°C, FIO2 = 21%) are used in the calculations.

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When TIME DRAWN is turned on, the operator will be prompted to enter the time the sample was drawn.

When SAMPLE TYPE is turned on, the operator is prompted to select arterial, venous or mixed venous.

When SAMPLE SITE is turned on, the operator is prompted to select brachial, femoral, arterial line cord or other.

When OPERATOR ID is turned ON, the operator will be prompted to enter an operator ID for each patient and quality control sample. A maximum of 14 digits is accepted. The barcode reader may be used to enter the operator ID.

DELETE DATA

Delete all stored patient or quality control results.

ALL PATIENT RESULTS

Delete all stored patient results. Press YES to confirm deletion of all patient results.

ALL QC LEVEL 1, 2 or 3, ALL HCT LEVEL 1, 2 ALL PATIENT RESULTS

Delete stored quality control results or patient results.

Adjust Display

Adjust the brightness by continuing to press the number 1 or number 2 keys until acceptable. Reverse the contrast of the display by pressing the number 3 key.

Page 100

5. Sample Handling and Collection

For complete sample handling and collection information, refer to a textbook of standard clinical chemistry procedures.

Biohazard: Human body fluid specimens may be contaminated with HIV or other pathogens. Treat all specimens, collection devices and tools as biohazardous.

The patient’s status is extremely important when preparing to draw an arterial blood specimen. Patients receiving certain drugs, such as anticoagulants and thrombolytics, are at a greater risk for hematoma or external bleeding. The correct puncture location and sample timing is important in preventing bleeding.

Blood gas samples must be collected into syringes/ capillary tubes containing heparin, including samples from patients receiving heparin treatments. A final heparin concentration of 15-50 IU/mL is recommended. Calcium balanced heparin is recommended. Ammonium heparin will shift the pH of the patient sample analyzed. Using sodium heparin will increase the sodium level of the patient sample.

Syringe Sample

1 Draw blood into a syringe which is pretreated with liquid heparin

or use a prepackaged syringe treated with dry lyophilized heparin. The syringe must be completely filled to assure the proper anticoagulation concentration. When preparing an untreated syringe, only 0.05 mL of liquid heparin (1000 IU/mL) is necessary to anticoagulate 1 mL of blood. Too much heparin can alter the blood gas values obtained. Make sure that no air bubbles are present before sealing the syringe with an airtight cap. Note the time of collection.

2 Mix the specimen with anticoagulant by gently inverting the

syringe several times. DO NOT SHAKE.

Failure to use the proper sampling materials and methods will result in microclots which will degrade the system and result in reliability issues such as PCO2 and PO2 electrode failures.

3 Analyze specimen within 5 minutes of collection, or immerse the syringe

barrel in an ice water bath. The ice water bath maintains an accurate sample for up to 2 hours at a temperature between 1 and 5°C.

Note: Use only the Medica Capillary Kit. Use of other capillary tubes may cause erroneous results, or damage to the analyzer and electrodes.