3M Sarns TCM II Bedienungsanleitung

TERUMO 1005

Sarnsm

TCM

OperatOrs

Manual

System

Software

Version

2.0

Remote

Software

Version

Health

are

TERUMO

1005

Sarnsw

TCM

Operators

Manual

4415

115

with

Cardioplegia

(3M

ID.

No.

98—0702-0629-1)

4416

220-240

with

Cardioplegia

(3M

ID.

No.

98-0702-0627-5)

Cautions

Caution:

FEDERAL

UJ.S.A.)

LAW

RESTRICTS

THIS

DEVICE

SALE,

DISTRIBUTION

AND

USE

THE

ORDER

PHYSICIAN.

Proper

surgical

procedures

and

techniques

are

the

responsibility

the

medical

profession.

the

operator’s

responsibility

use,

check,

and

maintain

this

device

according

the

labels

the

product,

accompanying

instruction

manuals,

and

any

revisions

the

labeling

instruc~

tions

that

may

subsequently

issued.

Service

Policy

Contact

Sarns

Service,

your

local

subsidiary

your

authorized

Sarns

distributor

and

describe

the

problem

before

attempting

service

return

this

device.

Instructions

will

then

given

for

correcting

the

problem

returning

the

device

and

Returned

Goods

(RG)

number

will

issued,

Returned

devices

must

packaged

with

adequate

protection

against

shipping

damage.

Include

note

describing

theproblem,

stating

the

number,

and

giving

the

name,

address,

and

tele-

phone

number

person

contact

for

additional

information.

the

United

States,

contact

the

Sarns

Service

Department:

Sarns

Health

Care

6200

Jackson

Road

Ann

Arbor,

Michigan

48103

USA.

Telephone:

(800)

521—281

Telex:

4930455

SARSVC

Outside

the

United

States,

please

contact

your

local

subsidiary,

your

authorized

Sarns

distributor

the

International

Department

Sarns.

Telephone:

(313)

663

-5

123

Telex:

4930456

SARINC

Facsimile:

(313)

741-6449

Table

Contents

LAU‘IU'ILIIUI

\0000\

Product

Definition

Description

Indications

Contraindications

Warnings

Precautions

Controls

And

Displays

Main

Unit

Cardioplegia

Water

Supply

Temperature

DisplayModule

Preparation

Checking

Ice

And

Water

Connecting

Equipment

Starting

And

Priming

The

System

Operation

Using

The

System

Resolving

Alarm

Conditions

Correcting

Equipment

Problems

Using

The

Ice

Maker

Maintenance

Setup

Sanitization

Procedure

Cleaning

and

Sanitizing

Procedure

Clean

the

Coils

Descaling

Procedure

Decontamination

Procedure

Periodic

Operator

Checks

Sarns

Service

Checks

Accessories

Inspection

And

Repair

Record

Product

Description

Specifications

Functional

Description

Theory

Operation

Product

Definition

Description

The

SarnsTM

TCM

(system)

source

tempera-

tum-controlled

water

for

blood

heat

exchangers

used

extracorporeal

circuit

and

for

blankets

externally

heat

cool

the

patient.

also

freezes

water

for

ice

supply,

monitors

temperatures

the

patient

and

extracorporeal

circuit,

and

allows

gradient

rewarming

relative

venous

blood

temperature.

The

SarnsTM

TCM

also

features

Cardioplegia

System

which

will

supply

cooling

water

for

cardioplegia.

Note:

For

complete

description,

see

the

Specifica-

tions,

Functional

Description,

and

Theory

Operation

the

Product

Description

section

this

manual.

Indications

The

SarnsTM

TCM

indicated

for

controlling

and

monitoring

patient

temperature.

Contraindications

This

device

not

designed

sold,

intended

for

use

except

indicated.

Warnings

the

operator’s

responsibility

use

the

SarnsTM

TCM

and

any

attached

equipment

according

the

manufacturer’s

instructions

and

good

medical

prac—

tices.

The

SarnsTM

TCM

not

completely

automatic;

responsibility

for

monitoring

patient

temperatures

and

rate

temperature

change

remains

with

the

operator.

obtain

accurate

temperature

readings,

use

only

probes

specified

Sarns

for

use

with

the

Temperature

Probe

Module.

Take

care

when

displaying

the

alarm

setting.

Depress-

ing

the

alarm

switch

for

than

second

will

change

the

alarm

setting,

control

bacteria,

maintain

chlorine

level

between

ppm.

Observe

proper

safety

precautions

when

using

S-Klenz

this

phosphoric

acid

detergents

not

mix

S-AKlenz

(acid

descaler)

with

the

Process

LCS

(chlorine

sanitizer)

exothermic

reaction

will

occur,

creating

harmful

chlorine

gas.

Precautions

The

system

must

properly

primed;

running

the

pumps

and

heaters

with

the

device

dry

will

damage

them.

The

water

level

the

large

tank

must

never

rise

above

the

maximum

level

water

may

damage

the

inside

the

unit;

this

water

level

should

not

drop

below

the

minimum

level

there

may

loss

system

performance

(see

maximum-minimum

label).

The

SarnsTM

TCM

requires

dedicated

Amp

power

source

for

the

115

volt

model

and

dedicated

Amp

power

source

for

the

220-240

volt

model.

Grounding

reliability

can

only

achieved

when

this

equipment

connected

to'an

equivalent

receptacle

marked

“Hospital

Use”

“Hospital

Grade”

which

has

been

inspected

for

proper

grounding.

Use

care

when

handling

the

Temperature

Display

Module;

the

controls,

displays,

circuitry

may

damaged

the

module

dropped,

struck>

immersed

water.

Use

only

Cage

Klenz

[00,

Process

LCS

and

S—Klenz

cleaning

agents,

following

the

manufacturer’s

direc-

tions

and

safety

precautions.*

not

exceed

the

recommended

strength

prevent

corrosion

damage.

avoid

corrosion,

not

allow

the

chlorine

level

exceed

ppm.

not

use

chemical

solvents

such

alcohol,

ether,

acetone,

etc.

any

part

the

system

such

solvents

may

destructive

the

device.

not

spill

anesthetics

the

system

accessories

chemicals

such

Foranc

(isofluoranc)

may

destructive.

Remove

any

lint

from

the

refrigeration

coils

prevent

damaging

the

ice

maker.

Take

care

when

cleaning

the

refrigeration

coils

the

coils

have

sharp

edges.

‘Cage

Klee:

100.

Process

LCS

and

S-Klenz

are

products

Calgon

Vestal

Laboratories.

St.

Louis.

Missmri,

U.S.A.

Controls

and

Displays

Main

Unit

Figure

Side

Panel

System

Power

Switch

turns

the

system

power

and

off

and

serves

circuit

breaker

for

the

system.

Ice

Maker

Switch

turns

the

ice

maker

and

off

and

serves

circuit

breaker

for

the

compressor.

When

the

ice

maker

switch

on,

the

compressor

cycles

and

offas

needed

make

and

maintain

ice

block.

Controls

and

Displays

Main

Unit

(Continued)

Modes

are

started

depressing

the

mode

switch;

modes

are

stopped

selecting

another

mode.

The

Defrost

mode

unique

that

may

entered

only

from

the

Standby

mode

and

stopped

returning

the

Standby

mode.

All

select

switches

must

depressed

for

least

1/2

second

green

LED

lights

indicate

which

functions

are

selected.

STANDBY

CDDLDOWN

ICE

MAKING

GRADIENT

A6“

_\10’

CAR

DIOPLEGIA

H20

‘C

Figure

Front

Panel

ICE

NIAKING

Indicator

Lamp

fights

when

the

ice

making

fimction

active.

Water

Temperature

Display

shows

the

output

water

temperature

Cardioplegia

Water

Switch

allows

momentary

display

the

cardiopleg'ia

outlet

water

temperature

the

Water

Temperature

display.

STANDBY

(Mode)

Switch

selects

neutral

mode

which

temperatures

may

read

but

valves,

pumps,

and

heaters

are

not

operating

(except

during

startup

when

the

valves

open

allow

internal

priming).

COOLDOWN

(Mode)

Switch

opens

valves

circulate

cold

Water

from

the

large

tank.

MAINTAIN

(Mode)

Switch

begins

warming

water

adding

cold

Water

attain

and

maintain

operator—

selected

temperature.

Maintain

Temperature

Display

shows

the

selected

maintain

temperature.

During

startup,

this

display

shows

the

software

version

and

then

25°C.

MAINTAIN

TEMPERATURE

Switches

raise

lower

the

maintain

temperature

setting

within

range

O“-42"C.

REWARM

ode)

Switch

activates

the

heaters

warm

water

maximum

rate

42°C

and

circulates

the

warm

water.

Gradient

Switch

limits

the

water

temperature

Maintain

Rewarrn

modes

than

6°C

10°C

above

the

temperature

read

Probe

This

switch

designed

for

use

with

venous

temperature

probe.

When

the

Gradient

switch

inactive,

the

maximum

rewarrn

temperature

automatically

42°C.

DEFROST

Mode)

Switch

circulates

warm

water

through

the

large

tank

until

the

water

reaches

20°C;

then

the

unit

automatically

reverts

Standby

mode.

The

following

alarms

have

specific

warning

indications:

red

LED

lights

indicate

the

specific

alarm

condition

and,

except

for

the

Low

Flow

Blanket

warning,

two-second

buzzer

sounds.

H10

42°C

LED

lights

warn

that

the

water

tempera—

ture

above

425°C.

The

heaters

are

automatically

turned

off.

The

light

and

bumer

warnings

will

continue

until

the

temperature

below

42°C.

Pump

Not

Primed

LED

lights

warn

that

the

main

pump

not

primed.

The

light

and

buzzer

warnings

will

continue

(or

reoccur)

until

the

pump

primed

and

restarted

pressing

Cooldown,

Maintain,

Rewarm

Defrost.

Low

Flow

Blanket

LED

lights

warn

that

the

water

flow

for

the

blanket

low.

Service

LED

lights

warn

that

the

temperature

display

and

temperature

control

malfunctioning.

Controls

and

Displays

Cardioplegia

Water

Supply

LARGE

SMALL

LARGE

use

RPM

TANK

SMALL

@@Q

7”

”2/

Figure

Cardioplegia

Panel

Cardioplegia

Switch

(CPG)

starts

stops

the

SMALL

TANK

Switch

sets

the

system

deliver

water

Circulating

pump.

Flow

parameters

are

water

from

the

small

tank

the

cardioplegia

water

determined

the

speed

and

water

circuit

selected.

outlet.

Speed

Switch

(RPM)

selects

the

cardioplegia

LARGE

SMALL

Switch

sets

the

system

pump

Speed.

LED

lights

for

low

speed,

LED

recirculate

water

from

the

large

tank

the

small

lights

for

medium

speed,

and

LED

lights

for

high

tank.

speed.

display

the

water

temperature,

use

the

Cardioplegia

LARGE

TANK

Switch

sets

the

system

deliver

Water

switch

the

main

panel.

water

from

the

large

tank

the

curdioplegia

water

outlet.

Controls

and

Displays

Temperature

Display

Module

Probe

LED

lights

identify

which

probe’s

information

being

displayed.The

LEDs

for

Probes

also

flash

indicate

alarms.

lithe

alarm

limits

for

two

probes

are

exceeded,

both

probe

LEDs

will

flash;

one

these

probes

also

selected

for

display,

its

LED

will

flash

higher

rate.

Probe

Labels

identify

the

probes.

The

labels

are

alphabetically

marked

correspond

with

the

probe

outlets

the

back

the

main

unit;

erasable

writing

space

available

mark

the

probe

location

the

patient

extracorporeal

circuit.

Probe

labeled

“Gradient.”

h‘.

HIGH

and

LOW

Alarm

Switches

display

set

tem—

perature

limit

alarms

for

probes

When

alarm

switch

depressed

for

less

than

one

second,

the

alarm

setting

for

the

selected

probe

displayed.

When

alarm

switch

depressed

for

than

one

second,

the

display

cycles

through

the

selection

range;

releasing

the

alarm

switch

will

set

the

last

displayed

number

the

new

alarm

limit.

the

temperature

exceeds

the

alarm

limit,

warning

buzzer

will

sound

once

and

the

probe

LED

will

flash.

IIEDMPLEBM

'l‘ES’l'

Switch

initiates

test

verify

that

the

Temperav

ture

Probe

Module

functioning

correctly.

During

this

test,

the

top

display

pertains

the

first

Temperature

Probe

Module,

the

middle

display

pertains

the

middle

Temperature

Probe

Module,

and

the

bottom

display

‘

Figure

Module

Panel

pertains

the

last

Temperature

Probe

Module.

When

the

test

switch

depressed,

the

display

must

indicate

:t:

.4°C;

the

display

will

blank

module

con—

nected.

Releasing

the

test

switch

will

return

the

display

its

prior

state.

the

top

this

module

are

the

controls

and

displays

for

temperature

monitoring

and

the

bottom

are

remote

controls

and

displays

for

the

Status”

TCM

II.

The

system

will

respond

the

most

recently

entered

information

regardless

Whether

entered

the

main

panel

the

remote

panel.

The

remote

control

switches

firnction

the

same

manner

their

counterparts

the

main

unit.

Probe

Display

Switch

selects

which

probe’s

information

will

displayed.

Selections

are

marked

the

switch.

The

probe

LED

lights

indicate

the

probe

selected.

Temperature

Display

shows

the

probe

tempera-

ture

and

the

following

information:

---

Indicates

that

there

probe

connected

that

the

temperature

below

-.4°C.

99.9

Indicates

that

the

temperature

over

50°C.

Blank

Indicates

that

there

temperature

conversion

module

that

the

module

not

functioning

correctly.

The

top

display

also

displays

the

selection

range

and

settings

for

the

temperature

limit

alarms.

Preparation

Checking

Ice

and

Water

See

that

the

System

Power

OFF.

Check

that

there

adequate

ice

supply.

lb.

supply

ice

should

sufficient

for

one

case.

make

additional

ice,

see

“Using

the

Ice

Maker”

the

Operation

section.

Add

fresh

cold

water

the

maximum

water

level

for

each

tank.

The

maximum

water

level

for

the

large

tank

indicated

the

label

located

near

the

pressure

switch

the

large

tank.

The

maxi—

mum

water

level

for

the

small

tank

attained

when

water

begins

overflowing

from

the

small

tank

the

large

tank.

Connecting

Equipment

Connect

the

Heat

Exchangers

and

Blanket

(Figure

Use

new

sections

PVC

tubing

connect

equipment.

Prepare

drainage

line

for

cardioplegia

and

arterial

water

Out

lines:

insert

ball—type

valve

(A)

into

the

middle

drainage

line.

the

valve.

Attach

the

drainage

line

tubing

section

with

tee

(B).

Figure

Water

Connections

Connect

the

Display

Module

(Figure

Select

any

5/8

in.(4,l

cm)

upright

pole

that

within

7.5

ft.

(2,3

the

main

unit.

Lower

the

support

bracket

(A)

over

the

pole

until

the

bracket

the

.v’—\

‘ ‘

desired

position;

tighten

the

thumbscrew

(B).

Position

A1130}!

the

water

fittings

(C)

the

tubing

SGCUODS

the

back

the

module

that

its

slot

directly

over

and

secure

the

connection

with

tubing

clamps

(D).

the

desired

support

tab

(C);

pull

the

module

downward

until

securely

the

tab.

Attach

the

tubing

sections

the

heat

exchangers

and

blanket.

Connect

the

Temperature

Display

Module

the

main

unit

before

the

System

Power

turned

on.

Insert

the

Insert

the

water

fittings

into

the

appropriate

and

module

plug

into

the

socket

which

located

the

Out

ports

the

system:

CPG

H20

for

the

pocket

the

main

unit.

sure

that

this

plug

cardioplegia

heat

exchanger,

ART

H20

for

the

securely

connected,

arterial

heat

exchanger,

and

BKT

H20

for

blanket.

Note:

During

use,

keep

the

drain

valves

closed

and

not

drain

attached

equipment.

The

system

ports

are

internally

connected

common

water

source

such

that

draining

the

attached

equipment

may

drain

the

entire

system.

Figure

Bracket

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