Mallinckrodt GEM-STAT User manual

—GEM

O

mm

MANUAL

STAT

all

ae)

mo

SENSOR

ウラ

SYSTEMS,

ククル

?

INC

GEM®-STAT

Operator’s

Manual

1230

Eisenhower

Ann

Arbor,

MI

48108

(800)

262-3654

(313)

973-7000

Place

350056A August,

1989

Table

PRODUCT А.

Intended

B.

Principles

C.

System

D.

Specifications

CONTROLS,

А.

Instrument

B.

Display

C.

Printouts

INSTALLATION

A.

Inspection

System

s

of

DESCRIPTION

Use

of

Operation

Components

DISPLAYS,

Displays

messages

of

Components

Installation

Contents

and

Features

AND

PRINTOUTS

and

AND

Keypad

PREPARATION

Functions

17

Installing Setting

gn

Inserting

™

CALIBRATION

A.

Calibration

B.

Quality Control

C.

Value

OPERATION A.

Summary

B.

2.

the

Limit

Running a Sample:

1.

Collecting

Entering

3.

Aspirating

4

Interpretation

Printer

Paper

Date

and

GEM-STATPAK

AND

Checking

of

Operation

Step

the

Blood

Patient

the

Sample

of

Time

QUALITY

by

Step

and

Operator

Results

CONTROL

Procedure

Identification

Numbers

17

18

19

21

24

25

26

26 26 27 28

C.

Other 中

D.

Cartridge

E.

Power

VI.

MAINTENANCE,

A.

Maintenance

B.

QC

C.

General

D.

Service

Instrument

Temperature

Duplicating

ya

E

Determining

^

Initiating

Initiating a two-point Data

Retrieval

Nou

Active

a

Standby

Keys

vs.

Functions

Correction

Printout

Cartridge

Removal

Interruption

and

TROUBLESHOOTING,

Troubleshooting

and

Returned

Mode

System

Goods

of

the

Last

Status

Calibration

Transport

Policy

Sample

Analysis

AND

SERVICE

30 30

31 31 32

33 33 35

36

37

39

39 40 41 45

VII.

ADDITIONAL

А. B.

Ordering Summary

INFORMATION

Information of

Cautions

and

Warnings

47

47 48

Product

A.

INTENDED

FEDERAL THE

ORDER

THE

GEM-STAT CHANGEABLE ONLY TIONS OPERATING

The

GEM-STAT

with

the

GEM-STATPAK,

crit

of

critically

Because

operate.

bedside,

try

The

control

at

of

Simple

thereby

measurement.

GEM-STAT

solutions

any

time.

LAW

OF A PHYSICIAN

BY

MALLINCKRODT

FOR

USE

THIS

patientside

ill

its

self-contained

operation

significantly

incorporates

so

USE

(USA)

COMPONENTS.

patients.

that

RESTRICTS

SYSTEM

PROVIDED

SYSTEM.

Blood

is

used

allows

the

system

CONSISTS

and

reducing

automatic

Description

THIS

OR

OTHER

WARNING:

USE SENSOR WITH

EACH

Chemistry

to

measure

automated

blood

samples

the

calibration

accuracy

DEVICE

LICENSED

OF

SEVERAL

COMPONENTS

SYSTEMS.

COMPONENT

Analyzer,

blood

gases,

design,

total

the

to

be

turnaround

and

can

be

TO

SALE

PRACTITIONER.

NON-INTER-

MANUFACTURED

READ

THE

when

used

electrolytes

GEM-STAT

analyzed

time

includes

verified

by

BY

OR

ON

INSTRUC-

BEFORE

in

conjunction

and

is

simple

at

the

patient

of a blood

end-user

the

system

|

hemato-

to

chemis-

quality

operator

Instructions

for

Use

B.

PRINCIPLES

The

purpose

results,

No

extraneous

electrodes cartridge. instrument, system Operating

Accuracy

calibrations

intervals. the

use

In

many

pumps, to

insure

nents

are

rejects

which degraded waste

life

of

with a minimum

and

Set-up

which

performs a 2-point

properly.

is

maintained

that

Any

time

of

independent

blood

and

valves

consistent

within

the

cartridge

is

long

before

performance

bag

that

the

STATPAK

OF

OPERATION

the

GEM-STAT

equipment

calibrating

consists

System

amount

or

reagents

of

solutions

of

inserting

initiates a completely

calibration

throughout

have

been

pre-programmed

during

gas/electrolyte

must

operation,

quality

control

analyzers,

be

regularly

performance.

the

disposable

when

any

due

automatically

cartridge.

GEM-STATPAK.

its

sample

of

the

individual

to

use.

collects

is

to

provide

user

preparation

are

required

are

contained

the

STATPAK

automated

and

numerous

the

life

of

accuracy

solutions.

the

checked

With

the

GEM-STAT

capacity

cartridge

Biohazard

used

blood

the

and

for

within

cartridge

warm-up.

self-checks

the

cartridge

to

occur

automatically

can

be

electrode

and

maintained

The

instrument

or

total

operating

components

has

been

and

flush

operator

maintenance.

calibration,

the

with

since

disposable

into

the

During

to

verify

via

one-

verified

membranes,

System,

by

the

by

the

all

of

automatically

life

would

minimized

by a sealed

solutions

fast,

accurate

ail

of

the

STATPAK

GEM-STAT

warm-up,

that

it

and

two-point

at

fixed

time

operator

solutions,

user

these

is

exceeded,

via

in

order

compo-

show

throughout

the

is

the

GEM-STAT

C.

SYSTEM

COMPONENTS

AND

FEATURES

GEM-STAT

Electronic and

*

+

GEM-STATPAK

Disposable flush

* *

+

©

(Prod.

instrument

hematocrit.

Measures Derives

Hard

copy

complete Front

Panel

analyte. Alphanumeric

prompts, Keyboard Temperature

solutions, Disposable Provides

Self-contained

and

waste

48

hour

No.

4300)

PO,,

PCO,

Base

Excess,

printout

sample

and

allows

(Prod.

cartridge

up

container.

standby

identification.

Display

additional

command

Correction

No.

containing

and

waste

to

50

tests

cartridge

period

for

analyzing

pH,

HCO;

automatically

provides

parameter

capability

4301)

container.

or

includes

extends

blood

K*,

Na*,

TCO,,

numeric

instrument

and

data

electrochemical

24

hours

sensors,

total

gases,

iCa**

and

O,

SAT.

provided

displays.

via

of

with

readout

status

entry.

entry

sampling

calibration

cartridge

electrolytes,

Het.

each

analysis

for

each

measured

information,

of

patient

sensors,

use

temperature.

calibrating

capability.

and

flush

life

to

72

assures

keyboard

and

solutions,

hours.

GEM-SAMPLER

Disposable attachment GEM-STATPAK

Instructions

for

(Prod.

cartridge.

Use

No.

4305)

that

allows

introduction

of

blood

samples

to

the

GEM-CHECK

Aqueous

permit

system

Low,

+

Allows

(Prod.

solutions

quality

Normal,

user

to

and

comply

No.

2306)

containing

control

High

values

with

known

checks

values

of

pH, PO,,

provided

laboratory

QC

of

gases

and

electrolytes

PCO,,

K*,

in

each

package.

requirements.

iCa**,

and

that

Na".

GEM-CRIT

Aqueous

system 4

Low

@

Allows

CHECK

solutions

quality control

and

Normal

user

to

(Prod.

simulating

checks

values

comply

No.

2309)

provided

with

known

of

values

Hct.

in

each

laboratory

QC

of

hematocrit

package.

requirements.

that

permit

6

GEM-STAT

D.

SPECIFICATIONS

WHILE SYSTEM THIS SPECIFICATIONS ANY

MALLINCKRODT

TO

MANUAL,

PARTICULAR

1.

PARAMETERS

MEASURED

PO,

pH

PERFORM

PARAMETERS

PCO,

Na*

Kt

iCa*

Het

DERIVED

PARAMETERS

HCO;

TCO,

Base

Excess

O,

SAT

SENSOR

WITHIN

IT

IS

THE

RESPONSIBILITY

AND

DETERMINE

APPLICATION.

CAUTION

THE

0

TO

6.80

5

to

99

100

to

0.1

to

0.1

to

5

to

60%

3.0

to

3.0

to

-30

to

30

to

SYSTEMS

SPECIFICATION

OF

THE

SUITABILITY

RANGE

400

mmHg

TO

7.80

mmHg

200

mM/L

9.9

mM/L

5.0

mM/L

RANGE

60

mM/L

60

mM/L

+30

mM/L

99%

WARRANTS

THE

USER

THE

LIMITS

OF

TO THE

STATED

REVIEW

RESOLUTION

1

mmHg

-01

1

mmHg

„1

mm/L

А

mM/L

.1

mM/L

.01

mM/L

1%

RESOLUTION

-1mML

„1

mWL

mL

1%

GEM-STAT

IN

THE.

SYSTEM

on

display

on

printout

FOR

e

2.

PHYSICAL

GEM-STAT

GEM-STATPAK

3.

OUALITY GEM-CHECK

GEM-crit

nstructions

for

SPECIFICATIONS

CONTROL

CHECK

Use

IN

INCHES

WIDTH

9.12

[23.2]

2.00 8.06 5.00 (5.1]

SOLUTIONS

3

levels

per

ampule

pH,

Low

Normal

High 2

ampule Het.

Low

Normal

contains

PO,,

Level:

levels

per

contains 3 ml

Level:

PCO,,

[CM]

DEPTH

18.25

[46.4]

[20.5]

package,

ml

3

K*,

10

Na*,

Lower

Normal

Higher

package,

Lower

Normal

I

of

than

15

of

than

HEIGHT

8.38 27.7

[21.3]

[12.7]

ampules solution

and

each pre-analyzed

iCa**.

normal

blood

values

normal

ampules

solution

each

pre-analyzed

normal

blood

values

Lr

WEIGHT

(12.6

level.

blood

level.

blood

re

lb. kg.)

25

oz.

(7

kg.)

Each

for

values

Each

for

values

E

II

IZ

N

4.

ADDITIONAL

Sample

Volume

SPECIFICATIONS

0.5

ml

Sampling

Response

Rate

Time

Measurement Methodology

Calibration

Temperature

Time

Power

Method

Control

and

Date

Requirements

Maximum

110

11

seconds

samples/hour

from

sample

PO,—Polarographic pH,

Na*,

K*,

iCa**,

PCO,—Potentiometric

Hct—Conductivity

Two-point

One-point

Electrode

Internal

Domestic

100

Export

instrument.

calibration

chamber

24

hour

Version:

Watts.

Version:

maintained

calendar

120

will

introduction

every

between

clock,

VAC

vary,

refer

60

minutes.

samples.

at

37°C,

battery

+10%

to

back

+0.2°C.

powered.

/-15%

panel

60

Hz,

of

Produa

Data

Sample

*

Safety

Output

type

Domestic

Port

version

only

UL

Listed

IEC

601.

RS

232

Whole units/ml

blood

Na

under

with

Heparin

UL-544*.

addition

or

Li

Designed

of

to

approximately

Heparin.

comply

with

25

GEM-STAT

USP

Controls,

Displays,

Il

&

A.

(Fig.

Printouts

INSTRUMENT

1.)

FRONT

PANEL

DISPLAYS

CONTROL

AND

&

KEYPAD

DISPLAYS

FUNCTIONS

|

°

1.

FRONT

DISPLAYS/KEYPADS

a.

Γ

PANEL

Numeric Na’,

K*,

pH,

PCO,,

[ом

PAPER

DISPLAYS

Window

iCa*,

PO,

FEED.

Displays;

на

AND

TEMP

KEYPADS

PG.

REF.

9

al

MENU

7! 8)

Displays last

parameter

blood

gl

FUNCTIONS

sample

PRINT

analyzed.

é

9

values

=

STATUS

for

ORİN

2

5

Instructions

Se

Cus

for

Use

|

E

EI

2

DISPLAYS/KEYPADS

b.

Alphanumeric

Display

c.

Sample Keypad

d.

Identification

e.

Paper

feed

f.

Enter

Keypad

g

Cancel

h.

Numeric

Secondary By

pressing

function

i.

1/STBY

j.

3/QC

k.

7/Temp

|.

8/Мепи

m.

9/Print

n.

0/Status

Keypad

Keypads

Keypad

SHIFT,

printed

(Standby)

(Quality

(Temperature)

Window

Keypad

Functions and

on

the

Control)

then

the

keypad,

PG.

REF.

Shows

RINSE,

user-supplied nos.,

26 26

17

26

appropriate

defined

31 21

30

33-36

31

Press

Press changing

Used

numerical or

operator

Press

return

Used

as

ID

numeric

follows,

as

Press

procedure.

Press previously

Press

menu. Press

of

sample. Press

vides STATPAK

FUNCTIONS

system

etc).

to

prior

to

to numbers.

to

most

to

information

status

STANDBY,

data

aspirate

feed

store

abort

will

initiate

temperature

select

obtain

initiate

blood

to

entering

paper

paper).

values

keypad,

ID,

temperature,

current

numeric

keypad,

occur:

Standby

QC

analyzed

option(s)

duplicate

recently

printout

cartridge

(READY,

etc.),

and

(Identification

sample.

ID

numbers.

(used

when

entered

such

mode.

the

Test

correct

sample.

analyzed

regarding

life.

on

as

patient

etc.

function and

data,

such

mode.

a

from

printout

blood

that

pro-

GEM-

2.

REAR

PANEL

CONTROL

Fig.

2.

Controls circuit

power

breaker.

to

instrument

(Fig.

2)

and

functions

GEM-STAT

as

B.

DISPLAY

BAD

MESSAGES

DATE:

LOT

NUM!

TIME

CANCELLING

CRC

FAILED

DATE/TIME?

EXITING

STBY

GOING 2 STBY

HTR

BLK

FAIL

INSERT LN

MUST

NO

OP

PA

PLEASE

PRINT

CART

000000000

DO

QC

GOOD

DATA

000000000

WAIT

ALL

MESSAGES

PG.

REF.

18

22

18

10

43

18

32

43

19

22

44

26

44

34

Invalid

Current

Indicates

again.

date

has

lot

number

time

has

function

hardware

Contact

been

is

customer

continues. Accessed

CARTRIDGE

view

return Occurs

pressing

system

Indicates

STANDBY

1/STBY Instrument

correct

through

or

set

date

to

the

SHIFT,

is

in

STANDBY).

that

mode

keypad

heater

operating

IS

NOT

and/or

the

instrument

(after

while

temperature.

Department. Instrument

A

prompt Controi Solution SHIFT,

QC

has

check

first

blood

Data calculation.

Operator

ID

number

otherwise entered

Patient number wise

Patient

A

request

ated

ing

another

Instrument

samples

is

ready

asking

then

QC

not

been

must

be run

sample

is

unavailable

ID

Number.

has

0's

will

ID

numbers.

ID

number.

has

not

0’s

will

be

ID

numbers.

has

been

because

the

task.

is

duplicating

via

request

that be

keypad).

run

not

previously

replaced

instrument

DESCRIPTION

entered.

has

been

entered.

being

fail;

MENU

INSERTED.

time,

mode

exiting

then

pressing

system

block

to

accept

the

entered

on

prior

on a new

to

complete a reguested

“0’s”

previously

be

replaced

“0's”

made

from

Try

entered.

Try

aborted.

turn

OFF,

service

of

1/STBY

has

lot

cartridge.

to

appear

all

if

keypad

or

CANCEL

WHEN

Press

operation.

STANDBY

keypad

is

going

the

is

in

READY).

failed

Contact

cartridge.

number

(after

pressing

analyzing

cartridge.

appear

been

by

previously

if a patient

been

entered,

by

previously

that

cannot

is

“busy”

QC

and

user.

again.

then

problem

SHIFT

to

At

if

Try

again.

ON.

Try

ENTER

to

(after

while

to

enter

then

maintain

Service

of

Quality

least 1 QC

the

an

operator

entered,

ID

other-

entered

be

initi-

perform-

patient

to

the

nt

DISPLAY

MESSAGES

PG.

REF.

DESCRIPTION

PRINT

PROCESS

*QC

R

READY

*RECOVERING*

REMOVE

SAMP

ALL

ALL?

Q-C?

1:49

READY*

YOU

SURE?

37.0

CART

CART?

SAMPLE

RINSE

M:SS

CANCEL *SAMPLING* *SELF

TEST

QC

C

34

27

22

36

25

37

36

27

15 27 25

Instrument

request

Accessed

operator

should CANCEL next

Accessed

operator

cated. or

8/MENU

Follows

remaining Quality

and Appears

cartridge. open

SERTED

The any

other

37.0° C unless

is

duplicating

from

user.

through

if

all

QC

be

duplicated.

to

abort,

request.

through

if

all

QC

Press

ENTER

to

continue

SAMPLING;

to

complete

Control

QC

solution

following

Press

door.

CARTRIDGE

IF

ENTER

instrument

commands.

manually

CANCEL

is

temperature.

Instrument Heater

readjust

RINSE

Cartridge hour

reached),

than

Accessed operator

access

or

CANCEL

User

Always

ING,

RETRIEVAL. amount

User

System

Occurs

power

is

recovering

block

will

to

correct

M:SS.

has

been

use

life

or

the

or,

power

30

minutes.

through

if

door

to

cartridge.

to

return

pressed

STANDBY,

CANCEL

occurs

following

The

of

time

pressed

CANCEL

is

aspirating a sample.

immediately

ON

and

all

MENU

and

or

MENU

keypad.

patient

Press

ENTER

8/MENU

keypad.

print-outs

to

print,

to

sample

Lot

Number

is

ready

to

be

operator

request

to

abort

CAN

IS

PRESSED.

ready

to

accept

Samples

corrected

from a power

take

up

to

temperature.

used

to

full

50

sample

was

disconnected

No

more

sampling

MENU

should

be

Press

ENTER

to

unlocked

during

SAMPLE

RECOVERING,

count

down

remaining

lasts for

in

during

following

about

QC

print

outs

Asking

sample

to

should

CANCEL

printouts

to

print,

continue

Asking

be

dupli-

to

request.

indicates

abort,

processing.

has

been

entered

analyzed.

to

remove

or

ENTER

NOT

BE

REIN-

samples,

are

analyzed

to

patient

failure.

4-1/2

minutes

Followed

capacity

(the

has

for

can

occur.

Asking

to

provide

to

unlock

mode.

“SAMPLING.”

PROCESS-

and

DATA

indicates

the

“PROCESSING.”

GEM-STAT

10

the

rinse

cycle.

seconds.

via

to

time

to

and

at

to

by

24

been

more

door,

12

ee

A

GEM-STAT

II

DISPLAY

MESSAGES

PG.

REF.

DESCRIPTION

"STANDBY"

*T=XX.X

2

PT

2

PT.

VALVE

WARMUP

*3/22/89*

"14:22:33"

CAL

CAL?

FAILED

C.

M:SS

43:00

32

30

25

33

25

Instrument

gramming Prompt

temperature

Occurs Instrument

The

countdown remaining following

is

in

or

sampling

asking

for a temperature

correction

after

pressing

is

performing a 2-point

in

the

WARMUP

thereafter. Accessed

operator

initiated. calibration,

to

continue

Indicates

ment. ment

disappear,

Indicates

pling

Countdown

Date

after pressed

Time

in

through

if a two-point

Press

CANCEL

to

an

May

be

OFF,

then

cail

that

and

performing

indicates

to

which

the

SHIFT

during

to

which

military,

or

corrected

the

24-hour,

the

STANDBY

can

take

can

7/TEMP.

indicates

the

calibration.

and

once

MENU

ENTER

ON

the

system

instrument

and INSERT

instrument

keypad.

calibration

to

perform

to

abort,

request.

problem

by

again.

Service

is

internal time

is

8/MENU

CART

format.

turning If

Department.

preparing

to

is

mode.

No

place.

input

so

be

performed.

calibration.

amount

Occurs

per

of

20

hour

time

minutes

Asking

should

two-point

or

8/MENU

with

the

instru-

the

instru-

message

does

for

calibrations.

complete

set;

keypads

warmup.

appears

have

mode.

set;

always

appears

pro-

be

not

sam-

only

been

Instructions

μον

for

ος

Use

Ἐ

ὁσ

κ

.

C.PRINTOUTS

The

following

are

examples

of

the G

EM-STAT

printouts.

1.

PATIENT

Sample

(Sequentially

Time

Date

Sample

Patient

Operator

Temperature are

reported

Blood

SAMPLE

Number 一一

numbered)

Sample

was

Identification

at

Values

PRINTOUT

analyzed

Number

which

values

ーー

Number

HSEM-ETAT+

(SAMPLE L

TIME:

DATE:

PAT.

OPER.

SA

HC03 TCD2 BE

K+

Ca++

NUMBER

В

a

ID:

ID

„Z

-

3.3

4.1

1.2immolsL

Fig,

3

ор

mmolsl

4

mmoleL mmol-«L

ot

2

し

2.

QUALITY

Sample

(Sequentially

Indicates

Control

Time

QC

Date

QC

Operator

Lot

Number

QC

Ampule

Level

of

QC

Test

CONTROL

Number

numbered)

that

sample

Sample

QC

(not a blood

solution

identification

corresponding

test

Values

PRINTOUT

ma

is a Quality

is

analyzed

is

analyzed

Number

solution

sample).

to

BEM

IN

MPLE AL.

CONTROL TIME: DATE: OPER. LOT

HUM:

LOW

LEVEL

PH

PCO2

202

Na+

K+ Datt

KK

==

TAT

HUMBER

A

ID:

+

CHEC

GEM-STAT

Mallinckrodt GEM-STAT User manual

Specifications and Main Features

Frequently Asked Questions

User Manual