Bard CritiCore 000002 User manual

0 (0)

Bardº

CritiCore” Monitor

Service Manual

Model

Number: 000002

Issued: June 1, 1997

Pl 3336

[BANA

C.R. Bard, Inc.

Covington, GA 30014

 

Copyright

Notice to Service Personnel

РР

© 1997 C. R. Bard, inc. All rights reserved. Printed in the U.S.A.

Bard

and CritiCore are registered trademarks of C.R. Bard, Inc.

or an

affiliate.

This document and subject matter enclosed herein are proprietary information to which C.R. Bard, Inc. retains the exclusive right of dissemination, reproduction, manufacture, and sale. Any party accepting

this document agrees it shail not be duplicated in whole or in part, nor disclosed to others without written consent of C.R. Bard, Inc.

U.S. Patent Nos. 4,448,207, 4,658,834. Other patents applied for.

This manual will help you troubleshoot and service

the

Bard CritiCore

Monitor.

Use this

manual

in conjunction with

the Bard

CritiCore

Monitor

Operators

Manual.

 

 

 

 

 

 

 

 

 

Be sure to read these Manuais and become

familiar

with their

contents

before attempting

to disassemble or

repair

the

Bard

CritiCore

Monitor.

Please consult product labels and inserts for any indications,

 

 

contraindications,

hazards,

warnings,

cautions

and

directions

for

use.

The Bard CritiCore Monitor should be serviced by individuals with the credentials of a Certified Biomedical Equipment Technician (CBET) or equivalent only.

Caution:

Federal

(USA) law

restricts

this device

to sale by or on

the order

 

of physician.

 

 

 

 

 

 

Caution:

- The Bard

CritiCore

Monitor contains static sensitive electronic

 

devices. Do not attempt to disassemble the Monitor without the

 

proper

personal

and work station grounding apparatus.

Failure

 

to properly ground

both

your

body and your work station could

 

result

in

damage

to

the

Bard

CritiCore

Monitor.

 

Tabie of

Contents

NOS NY 2

Product

Description

 

 

 

Communications Module.

 

 

Functional

Checkout...

 

 

 

Troubleshooting

information

„13

Mechanical Testing and Repair Procedures.........

mens

20

Bezel

Enclosure

.

20

Bezel

Top

 

 

 

 

Membrane Switch..

 

 

 

Display

PCB

 

 

 

 

Temperature

Jack

 

 

 

Liquid

Crystal

Display

(LCD) ..

 

 

Front Enclosure Assembly Attraction Plates and Magnets .. Rear Enclosure

Battery Assembly... seen

Details of Electrical Operation. Fluid Output Electronics

Temperature Measurement Electronics Microcontroller Details

Display Electronics

 

 

Keyboard

Electronics ..

 

 

Power Management

sie

 

Electronic Testing and Calibration Procedures...

 

Power

Modules

 

 

Transducer .

 

 

 

Phototransistor ..

 

 

Tilt Sensor

 

 

 

 

Temperature

Electronics ....

 

 

Main

PCB.

 

 

 

 

CritiCore Communications

Module

 

Main PCB Component Map ......

 

Replacement

Parts List.

 

 

Product

Specifications ..

 

 

Measurement

Ranges and

Limits.

 

Instrument

Specifications ...

 

 

index

 

 

 

 

 

CritiCore Monitor Schematics.…….... "eos

73

Bard CritiCore Monitor Service Manual

Page 1

Introduction

Warranty Repairs

This manual provides the technical service information necessary to maintain

satisfactory operation of the Bard CritiCore Monitor. It is intended for use by qualified personnel who are familiar with electro-mechanical devices, and in particular, microprocessor-controlled patient monitors. Use this manual in conjunction with the Bard CrítiCore Monitor Operator's Manual.

The contents of this manual are summarized below.

1.Product Description—Description ot Bard CritiCore Monitor functions,

specifications, and product information.

2. Functional Checkout—Use this test procedure to verify correct

* operation

of the Monitor.

If

the

Monitor

fails

any

test

within

the checkout,

the CBET

will

be

referred

to

the

necessary

sections

of

this

manual

for

turther testing.

After repair

is made

(by

either Bard

or

the

CBET),

use

the Functional Checkout procedure to verify correct operation before

returning

the Bard

CritiCore

Monitor

for

general

use.

 

 

 

 

3.Troubleshooting Information—For monitors with an obvious or

predetermined failure, use this guide to identify the necessary tests to isolate the problem.

4. Mechanical Testing and Repair Procedures—Use these procedures

to

test,

disassemble

and reassemble

the Monitor.

After repair is made

(by

either Bard or the

CBET), use the

Functional

Checkout

procedure to

verify correct operation before returning the Bard

CritiCore

Monitor for

general

use,

 

 

 

 

5.Electronic Testing and Calibration Procedures—Use these

procedures to test and calibrate the

electronics of the

Monitor. After

repair is

made,

use the Functional

Checkout procedure to verify correct

operation

before

returning the Bard

CritiCore Monitor

for general use.

6.Replacement Parts Kit List—Listing of available Bard replacement parts.

Note:

The Bard

CritiCore Monitor

contains

many custom mechanical

 

and electronic components. To ensure safe and proper

 

operation of the Monitor, use only Bard replacement parts as

 

specified

in the replacement

parts kit

list.

7.Product Specifications—Measurement ranges and limits along with instrument specifications.

8.Schematics—Schematic diagrams for the CritiCore Monitor. Includes

control block diagrams and timing charts.

 

 

 

 

 

Bard provides a 90-day limited warranty on each Bard

CritiCore

Monitor. All

repairs on products under warranty

must

be

performed at

a Bard

designated

repair facility.

If there

is

any evidence of

unauthorized

service

the customer

may forfeit any warranty

provisions

and

may

be billed

for

the

repairs required

to return

the

Monitor

to

its original

condition.

 

 

 

 

 

To obtain technical support, product information, and

for

placing

orders

contact

Bard

Customer

Service at

1-800-526-4455.

 

 

 

 

Bard CritiCore Monitor Service Manual

Page 2

Non-Warranty Repairs

Contacting Bard

Monitors no longer under warranty may be repaired within the following constraints:

1. Only

components included in the replacement parts list are used to make

the

repair.

2.No component has been removed from the Monitor unless that

component is specified in the replacement paris list.

3.

Each

repaired

Bard

CritiCore Monitor

passes

the Functional Checkout

 

(see

page

7) before

it

is returned

for

general

use.

Call Bard Customer Service Department (1-800-526-4455) to order

components

necessary

to

complete

a repair.

 

For

orders

and

technical

support,

contact Bard

Customer Service at

1-800-526-4455 between 8:30AM and 4:30PM eastern time, Monday

through

Friday.

When

calling for technical support, please be prepared to

supply the following

information:

 

 

 

*

Your

Name

 

 

 

 

 

 

 

*

Hospital

Name

 

 

 

 

 

 

«+

Address

 

 

 

 

 

 

 

 

*

Telephone

Number

 

 

 

 

 

+

Unit

Model

Number

 

 

 

 

 

*

Unit

serial

number

 

 

 

 

 

* Description of the reported problem

+ Was ihe Monitor used on a patient when the problem occurred? ‚ Paiient status and type of intervention required (if applicable).

If you are advised to return the Monitor to a Bard-designated repair facility, a Return Authorization Label or detailed mailing instructions, with the name

and address of the repair facility, will be supplied to you by your Bard Customer Service Representative.

To return the Bard CritiCore Monitor for service: 1. Remove and dispose of 6 D-cell batteries.

2.Package the Monitor with adequate protection. if available, use the

original materials in which the Monitor was shipped.

8.

Include

a brief description of

the

problem

as well as

the name and phone

 

number

of the person to be contacted for

additional

information.

Note:

 

Apply a label with the return authorization number to the

 

 

 

shipping

carton.

 

 

 

 

3.

Ship

the

Monitor

Transportation

Prepaid

to the location specified by

 

your

Bard Customer Service

Representative.

 

4. If requested, Bard will evaluate the Monitor and provide an estimate before any repairs are made.

’ Bard CritiCore Monitor Service Manual

Page 3

Product Description

The Bard

CritiCore System consists

of a fluid

output

and

core temperature

 

monitor, a disposable collection system, and disposable temperature probes

 

(temperature-sensing Foley catheters).

 

 

 

 

Note:

Consult the Operators

Manual for

details

on

all Bard CritiCore

 

 

 

 

 

 

Monitor functions.

 

 

 

 

 

 

 

-

 

 

 

 

 

 

Fluid Ouput

The

Bard CritiCore Monitor electronically measures fluid output volume

 

utilizing

ultrasound

technology.

During

operation,

the

disposable

container

 

rests within the Monitor and sits on top of a silicone rubber transducer cap.

 

Underneath the silicone rubber cap is the transducer element, which will

 

periodically transmit a controlled burst of ultrasonic energy up through the

 

container.

 

Ultrasonic

energy

will

travel

through the fluid and reflect back

 

towards the transducer at the fluid/air interface.

The

transducer

also

 

 

functions as receiver, detecting the return of the transmitted

burst.

The

 

microcontroller within the CritiCore Monitor will

measure

the

time

the

energy

 

burst took

to make the round-trip. This

information

is

then

converted

into

 

container

volume.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Temperature Measurement

Bladder

Temperature

is

measured

by

a

 

temperature-sensing Foley catheter.

 

The

temperature sensor integral to the

disposable

catheter

 

is a “400-Series”

 

thermistor.

 

As

the

Bladder Temperature

changes,

so

does

 

the

resistance of

 

the

thermistor.

Sensitive

electronics

in

the Bard

CritiCore

Monitor

will detect

 

any

change

in

the

resistance

of

the

thermistor.

The resistive vaiue of

the

 

400-Series thermistor is converted into

a

corresponding

relative

temperature

 

reading.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The

CritiCore Monitor incorporates the following features:

 

 

 

 

 

 

+

|

Present

Interval Output

Calculation

 

 

 

 

 

 

 

 

 

 

 

 

+

©

Prior

 

Interval Output

Calculation

 

 

 

 

 

 

 

 

 

 

 

 

 

+

 

Cumulative

Output

Calculation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

»

 

Container

Volume

Measurement

 

 

 

 

 

 

 

 

 

 

 

 

 

*

 

Flow

 

Rate

Calculation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 1

Bard CritiCore Monitor Service Manual

Page 4

i

i

i

 

/ fee

ο i

Communications

 

Module

 

 

 

 

 

 

The Bard CritiCore Monitor was designed to accommodate the Bard

CritiCore

Communications

Module (highlighted

area

in Figure

2).

The

function

of the CritiCore Communications Module (CCM) is

to

permit

communications

between

a

computer or

patient

data

management

system

and the

CritiCore Monitor.

 

 

 

 

 

 

 

 

Note:

 

Consult

the

CCM

Operator's

Manual

for

details

on

all

CCM

 

 

functions.

 

 

 

 

 

 

 

 

 

With

the

CCM,

the user

may

configure the CritiCore

Monitor

to

transmit data

in one

of

four modes

(see

Figure 3):

 

 

 

 

 

 

*210 Emulation mode—Emulates the manner in which the Bard

 

Urotrack® Model 210 Monitor communicates its

data.

Flow

rate

and

 

container

volume are

transmitted

in this mode.

 

 

 

 

 

 

+

220 Emulation

mode—Emulates

the manner in

which

the

Bard

Urotrack

 

Model 220 and Urotrack Model 224 Monitors communicate their data.

 

Bladder temperature and container volume data

are

transmitted

in this

Figure 2

mode.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

*

Standard

mode—This

mode

is

designed

to

access

all

of the

information

 

-available from the Bard CritiCore

Monitor.

Flow

rate,

bladder

 

 

 

temperature

and

container

volume

data are

transmitted

in this

mode.

+

FlexPort”

mode—Allows

the

user

to set

up

communication

between the

 

Bard CritiCore Monitor and a

SpaceLabs

Medical

Patient Care

 

 

 

Management

System

(PCMS°)

Monitor.

 

 

 

 

 

 

 

у

Page

5

Bard CritiCore Monitor Service Manual

Figure 3—CritiCore Monitor with CCM Installed

Bard CritiCore Monitor Service Manual

Page 6

Functional

Chec t

Product

Identification

Self Test

The Functional Checkout procedure is designed to verify that the CritiCore

Monitor

is

functioning

properly

before

it

is

placed

 

into

service.

 

This

 

procedure

is available

 

in

the

Operator's

Manual,

which

is

supplied

with every

Monitor purchased. The Operator's Manual can also be purchased

 

separately

(see

the

Replacement

 

Parts

List

on

page

68).

The

 

Functional

Checkout

procedure is repeated here for

reference.

In

addition

to

the

Functional

Checkout

procedure

 

are

the

use

of

the

T,

- T, Monitor test modes.

The

use

of these

test

modes

will

be

discussed

in

 

the

Additional

Testing

Modes

section

on page

12.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.

the

Bard CritiCore Monitor has been turned on

recently, be sure it has

 

been

turned

off

for

at

least

10

minutes

 

before

 

initiating the

 

self

test.

2.

Hang

the Monitor from a stable levet bracket or set

it

on a

stable level

 

surface.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3.

Clean

both the cavity that holds the collection container and the silicone

 

rubber

transducer cap located at the

 

bottom

of the

cavity.

 

 

 

Note:

 

Use a soft non-abrasive cloth dampened

with

warm

water and

 

 

 

mild

detergent,

alcohol

or

a

non-staining

disinfectant.

 

4.

Open

the

rear

control

panel

 

door

 

to

reveal

the

rear

panel

switches

5. Setthe toggle and rotary switches as follows:

Set Format

 

 

Set Value

Test Switch

CLOCK

 

 

42 Hr.

Normal Operation

Normal Operation

TEMPERATURE

°F

 

 

BACKLIGHT

 

Of

 

 

FLOW

RATE

DISPLAY

Off

 

 

FLOW

RATE

ALARM

Disabled

 

 

TEMP.

ALARM

Disabled

 

 

BEEPER

 

Audible

 

 

6.

Press the

ON/OFF

switch

on

the

membrane switch

to

turn the Monitor

 

ON.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The

Monitor

will emit

a short

“beep” and

perform

a

self test.

This

self test

 

should take about 4 seconds.

After the self test the Monitor will

 

 

automatically enter the normal operation mode.

 

 

 

 

 

Note:

If

the

Monitor

fails

the

self

test,

an error

code

“PPPP”

will

appear

 

 

in

the top

display.

 

 

 

 

 

 

 

 

 

Once the self test is completed and successful, the display should resemble Figure 4 with the exception of Not Level Indicator.

Note:

The

current time of day, time of the previously selected interval

 

and

interval length may differ from Figure 4.

Bard CritiCore Monitor Service Manual

Раде?

Check Container Status

1.

Lift

the

display

assembly

and install

an empty disposable container into

 

 

the

Monitors

front

cavity.

 

`

 

2.

Lower

the

iid ensuring that it completely closes and traps the container

 

 

within

the

Monitor.

 

 

 

 

3.

Verify

that

the Check Container status indicator on the display is not lit,

 

 

and

“O

ML"

appears

in the

Present

Interval Output display.

Temperature

1. Install

a temperature-sensing

Foley

catheter or

a temperature

calibration

 

plug into the temperature jack on the

left side of the display

assembly.

 

Note:

A precision

(0.1% or better)

decade box set to 1954.70 and

 

 

connected

to a 3.6mm

mono

mini-phone plug may be

used

 

 

instead of a

calibration

plug.

See page

59 for table

of

calibration

plug resistances.

2.Verify that the Check Probe status indicator disappears and that a temperature reading appears in the Bladder Temperature display. If

employing a temperature calibration plug the value should be 98.6°F + 02Ε.

3.Remove the temperature calibration plug or temperature-sensing Foley

catheter

and

verify that the Bladder Temperature window displays “--.-”

and that

the

Check Probe status indicator is lit.

System Clock

1.

Tur

 

the

SET

VALUE

rotary switch on the rear

control

panel to

the

 

 

HOUR

position.

Verify that

the hour segment,

PM/AM

 

and

Set

Value

 

 

status

indicators

are

flashing.

 

 

 

 

 

 

 

 

2.

Use

the

Tl

switches

on

the

membrane

switch

to

set the

system

clock to

 

 

the

correct

hour..

 

 

 

 

 

 

 

 

 

 

 

 

3.

Turn

the

SET

VALUE

rotary switch on the rear

control

panel

to

the

 

 

MINUTE

position.

Verify

that the minute segment

and

 

Set

Value status

 

 

indicator

are

flashing.

 

 

 

 

 

 

 

 

 

 

 

4.

Use

the

T

switches

on

the

membrane

switch

to

set the

minutes

of the

 

 

clock

to

the

correct time

of

day.

 

 

 

 

 

 

 

5.Return the SET VALUE rotary switch to the NORMAL OPERATION

position

and

verify

that the correct

time

appears on the display. Verify

that the

Set

Value

status indicator

is not

lit.

Intervals

1.

Turn

the

SET VALUE

rotary switch

to

the

INTERVAL position. Verify

 

 

that

the

interval segment,

HA/MIN

and

Set

Value

status

indicators are

 

 

flashing.

 

 

 

 

 

 

 

 

 

2.

Use

the

Tl switches

onthe

membrane

switch to

display

the following

intervals: 5 MIN; 10 MIN, 15 MIN, 20 MIN; 30 MIN; 1HR; 2HR.

3. Set the

interval length to the preferred

interval and

return the SET

VALUE

rotary switch to the NORMAL

OPERATION

position.

Page 8

Bard CritiCore Monitor Service Manual

Patient Data Heset/Present

Interval Output/Container

Volume

Figure 5

Flow Rate

1. Filla disposable container with water (approximately 2100mi) and hang it so that it is higher than the Monitor.

Note:

A 60cc irrigation

syringe can be used to fill the collection

 

 

container

or two

CritiCore disposable containers can be used for

 

this

procedure.

These

containers

should

be

dedicated

for test

 

use

only.

 

 

 

 

 

 

 

 

tf an irrigation syringe is

used,

proceed to

step 5,

otherwise continue

with

step

2.

 

 

 

 

 

 

 

 

 

2. Cut

the inlet

tubing

of a

second

disposable

container

one inch

below

the

urine sample

port

connector.

 

 

 

 

 

 

jnstall ihe modified second empty container into the Monitor.

 

tnser

the

plastic

molded

Control

Fit

connector at

the end of the drain

 

tube on the filled container into the soft plastic tubing on the second

 

container

extending

from

the

Monitor

(see Figure

5).

5.

Press

the

ON/OFF

switch

to

tum

the

Monitor

ON.

 

6.

Using

either the

irrigation

syringe

or

a

second

disposable container,

 

allow approximately 100ML of water

to

drain

into

the container in the

 

Monitor.

 

 

 

 

 

 

 

 

 

 

7. Wait approximately 10 seconds after the water has drained into the Monitor and the surface of the water is steady. The Monitor should read approximately “100 ML" in the Present Interval Output display.

8.Press the Container Volume switch. The display should read

approximately

“100

ml"

Verify that

the container volume disappears 30

seconds

after the container

volume

switch

is

pressed.

 

 

9. Press and

hold

the

Patient

Data Reset

switch

until

a short “beep”

is

heard.

 

 

 

 

 

 

 

 

 

 

 

 

 

10. Press the Container Volume switch

a

second

time.

The

Container

 

Volume

display

should

read

within

3mi of the value noted in Step 8 and

the Present

Interval

Output

display

should

read between

“0” and

“3 ML”.

1. Set the FLOW RATE toggle switch to the ON position.

2.Set the Interval length to “1 HR.”

Note:

 

 

If

at least

 

15

minutes

remain

in

the

current

hour,

proceed

with

 

 

 

 

step

3.

If

less than

15

minutes

remain

in the current hour, wait

 

 

 

 

until

the

 

beginning

of

the

hour

before

proceeding

with

step 3.

3.

Press

and

hold

the

Patient

Data

Reset

switch

until

a short

“beep”

is

 

heard.

Verify

that

“0

ML”

appears

in

the

Present Interval

Output

display

 

and

that

dashes

 

“----”

appear

in the

Flow Rate

display.

 

 

 

 

4.

Allow

a

small

amount

of

water

to

drain

into

the

container

in

the

Monitor.

 

The

Present

Interval

Output

should

display a new

reading

within

15

 

seconds

after

the

water

flow has

stopped

and

the

water

surface

is

 

steady.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bard CritiCore Monitor Service Manual

Page 9

Not Level Indicator

5. Repeat step 4 after each minute increment for 10 consecutive minutes,

adding only a small amount

of water

each

time.

 

After exactly 10 minutes the

current

Flow

Rate

display

should change

from dashes *---” to a value

that is 6

times

the

value in

the Present

Interval Output display.

 

 

 

 

 

~

With the Monitor ON, tilt

the

Monitor.

 

 

Verify that the Not Level

status indicator

becomes lit.

3.

Return the Monitor to a

level

position and

verify that the Not Level

 

indicator disappears.

 

 

 

Full Container Alarm

1.

Open

the

drain

clamp

on

the

upper container or use an irrigation syringe

 

 

to fill

the

container

in

the

Monitor to 2050 mi of

water.

 

2.

Verify

that the

Full

Container

status indicator flashes and an audible

 

 

alarm

is

heard.

Note

that

the

BEEPER toggle

switch should be in the

 

 

AUDIBLE

position.

 

 

 

 

 

3.Press the Container Volume switch and verify that the Container Volume

displayed is greater than 2000mi and is flashing.

4.Drain about 200ml from the Monitor container and verify that the Full

Container status indicator is not lit and the audible alarm stops beeping.

5.Press the. Container Volume switch and verify that the Container Volume

 

displayed is

less

than

2000ml

and is

not flashing.

High Temperature Alarm

Before performing this procedure,

remove

any temperature probes or

 

calibration plugs

and

reset

the Monitor.

'

1.Set the TEMP ALARM toggle switch to the ENABLED position and the BEEPER toggle switch to the AUDIBLE position.

Verify that the bell icon appears in the upper right corer of the Bladder

Temperature display.

2.

Turn

the

SET

VALUE

rotary

switch

to the

HIGH

TEMP.

ALARM

position.

3.

Verify

that the Set

Value

status

indicator

and 101.0°F flashes

on

the

 

display.

The

High

Alarm

and

Check

Probe

status indicators should also

 

be lit.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note:

 

The

101.0°F

will

appear only if the temperature

alarm

default

 

 

 

limit

has not

been

reset

or

if

both

battery

packs

have

been

 

 

 

removed

for

an extended

period

of

time.

 

 

 

 

4. Use the Tl switches on the membrane switch to set the alarm limit to 98.4°F.

5.Turn the SET VALUE rotary switch to the NORMAL OPERATION

position.

Insert

a

98.6°F

calibration

plug. Verify that

the High Alarm

status

indicator

is

lit,

the

value in

the

Bladder

Temperature display is

98.6+

0.2

°F,:and

is

flashing and

the

audible

alarm is

beeping.

Page 10

Bard CritiCore Monitor Service Manual

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