Service Manual APM 235288500

Respironics® 5000S APM Operation/Service ManualRespironics® 5000S APM Operation/Service Manual 1

5000SAirway Pressure Monitor

Operation/Service Manual

48

235288500HM 1/2/03

Respironics® 5000S APM Operation/Service ManualRespironics® 5000S APM Operation/Service Manual2

SECTION TITLE PAGE

I Introduction to the Airway Pressure Monitor 4Warnings, Cautions and Notes 5

II Receiving Inspection 9Battery Installation 9

III Description of Controls 10Recommended Tubing and Filter 17Monitor Connections 17Pre-installation Checkout 18Installation Instructions 21Location/Mounting 22Sensor Hookup 22

IV Controls and Displays 24Monitoring Applications 24Preoperational Check 25Routine Operation 26Suggested Operational Parameters 28Alarm Interpretation 29

V Operational Maintenance 30Periodic Checks 30Cleaning 30Storage 31Battery Replacement 31Pressure Gauge Zero Adjustment 32Disposal 32Sensing Accuracy Check 32Zero Span Adjustment 33

VI Specifications 35Glossary 37

TABLE OF CONTENTS

47

Respironics, Inc.® warrants that the Airway Pressure Monitor shall be freefrom defects of workmanship and materials and will perform in accordancewith the product specifications for a period of one (1) year from the date ofsale by Respironics, Inc. to the dealer. If the product fails to perform inaccordance with the product specifications, Respironics, Inc. will repair orreplace, at its option, the defective material or part. Respironics, Inc. willpay customary freight charges from Respironics, Inc. to the dealer locationonly. This warranty does not cover damage caused by accident, misuse,abuse, alteration and other defects not related to material or workmanship.

RESPIRONICS, INC. DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS,LOSS OF PROFITS, OVERHEAD OR CONSEQUENTIAL DAMAGESWHICH MAY BE CLAIMED TO ARISE FROM ANY SALE OR USE OFTHIS PRODUCT. SOME STATES DO NOT ALLOW THE EXCLUSION ORLIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THEABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.

THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WAR-RANTIES. IN ADDITION, ANY IMPLIED WARRANTIES, INCLUDING ANYWARRANTY OF MERCHANTABILITY OR FITNESS FOR THE PARTICU-LAR PURPOSE ARE LIMITED TO ONE YEAR. SOME STATES DO NOTALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS,SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WAR-RANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSOHAVE OTHER RIGHTS WHICH VARY FROM STATE TO STATE.

To exercise your rights under this warranty, contact your local, authorizedRespironics, Inc. dealer or Respironics at 800-345-6443 (US or Canada), or+01-724-387-4000.

LIMITED WARRANTY

SECTION VIII


SECTION TITLE PAGE

VII Service 38Circuit Description 39Calibration 40APM Circuit Board Schematic 43APM LED Wiring Diagram 44APM Pulse PWB Assembly 45APM Wiring Diagram 46

VIII Warranty 47

46

9 V

OLT

BA

TT

ER

YW

ITH

CLI

P C

ON

NE

CT

OR

RE

D

BLA

CK

BLA

CK

RE

DA

C- + BLA

CK

RE

D

+-

"RE

MO

TE

OU

T"

SH

ELL

RIN

GT

IPJ3

R33

5.62

K

BR

IDG

ER

EC

TIF

IER

BLA

CK

PS

W1

BR

OW

N

RE

D

BLA

CK

GR

EE

NB

LUE

RE

DB

LAC

K

GR

EY

BLU

E

VIO

LET

YE

LLO

WY

ELL

OW

OR

AN

GE

VIO

LET

GR

EE

NG

RE

EN

GR

EE

N

WH

ITE

BR

OW

N

OR

AN

GE

WH

ITE

YE

LLO

W

MA

IN P

WB

PN

B V+

L H

LH

HV

LD

TR

J2-1

0J2

-11

J2-8

J2-7

J2-1

J2-2

J2-3

J2-5

J2-6

J2-4

J2-9

"HIG

H P

RE

SS

UR

E"

LED

3

"LO

W P

RE

SS

UR

E"

LED

2

"RE

PLA

CE

BA

TT

ER

Y"

LED

1

"LO

W D

ISA

BLE

"

ON

S2

FR

ON

T P

WB

"IN

AD

VE

RT

EN

T O

FF

"LE

D 4

ON

OF

F

ON

OF

F

S1

"ON

/OF

F"

N.C

.

R29

1M "LO

W D

EL

AY

""Z

ER

OA

DJU

ST

"

AP

M W

IRIN

G D

IAG

RA

M

NO

TE

S:

1. A

LL C

AP

AC

ITA

NC

E V

ALU

ES

AR

E IN

FA

RA

DS

UN

LES

S O

TH

ER

WIS

E S

PE

CIF

IED

.2.

ALL

RE

SIS

TA

NC

E V

ALU

ES

AR

E IN

OH

MS

UN

LES

S O

TH

ER

WIS

E S

PE

CIF

IED

.

-+ R14

10K

"LO

WS

ET

"

"HIG

HS

ET

"

R13

10K

R10

20

K

U10

M0C

8020

N.C

.6 4

1 25

T1

VIO

LET

PA

D1

R1

10K

Q1

PA

D2

BLA

CK

LED

1

R3

1K

D1

R2

2.

21K

P1-

4

P1-

3

PU

LS

E P

WB

SECTION VII


AIRWAY PRESSURE MONITOR

The Airway Pressure Monitor (APM) is a stand-alone accessory designedto supplement patient monitoring during ventilation. Its purpose is to notifythe medical personnel and/or user of undesirably LOW (as in a disconnectsituation) or HIGH pressures at a specific point in the breathing cycle.

The APM is especially suited to the needs of low pressure ventilatingsystems. Because the APM is scaled from -30 to +120 cm H2O, it giveshigh resolution within its intended operating range.

Before operation of the APM, you should read this Operation/Service Manualto familiarize yourself with the proper operating techniques. You should alsobe aware of all Warnings, Cautions, and Notes.

You should also review the Operation/Service Manual in order to fullyinstruct the patient on the proper use of the APM.

A 9-volt alkaline battery is installed in the APM.

SECTION I

INTRODUCTION

45

AP

M P

UL

SE

PW

B A

SS

EM

BL

Y

P1-

4

AP

M P

ULS

E P

WB

AS

SY

.P

/N 2

3526

5500

TO

"N

" O

N A

PM

MA

IN P

WB

TO

PIN

2 O

F U

10 (

M0C

8020

) O

N A

PM

MA

IN P

WB

P1-

3

(NO

TE

3)

R2

2.21

KD

1

1N41

48

R3

1K LED

1E

SP

Y57

01

Q1

PN

100

R1

10K

PA

D2

PA

D1(PU

LSE

D V

DD

)

TO

GR

OU

ND

TE

RM

INA

LO

F R

EM

OT

E O

UT

CO

NN

EC

TO

R(4

" B

LAC

K W

IRE

)

TO

Q1

CO

LLE

CT

OR

ON

MA

IN A

PM

PW

B(4

" V

IOLE

T W

IRE

)

SECTION VII


Below are the definitions of Warnings, Cautions, and Notes used in thismanual:

WARNING: Means there is the possibility of personal injury to yourself orothers.

CAUTION: Means there is the possibility of damage to the instrument orother property.

NOTE: Indicates points of particular interest for more efficient andconvenient operation.

This symbol on a medical device means “Attention, consultaccompanying documents”.

This symbol means Direct Current.

WARNINGS

• The 5000S should NOT be used to monitor Neonatal Ventilators, Highfrequency Jet Ventilators, Oscillation Ventilators, or ANY SYSTEMproviding rates above 60 bpm.

• For the following reasons, constant attention by qualified medicalpersonnel is required whenever a patient is attached to a ventilator :

1. Some malfunctions require immediate corrective action.

2. Any monitor, or any combination of monitors, does not give absoluteassurance of warning in the event of any and every form of malfunc-tion of the ventilator or gas delivery system.

Qualified personnel should be able to respond in a timely mannerto alarm conditions. The attention level required when a patient isattached to an assist ventilator must be determined by theprescribing physician based on the requirements of the patient.

• DANGER - Explosion Hazard. DO NOT USE in the presence of flam-mable anesthetics.

SECTION I

WARNINGS, CAUTIONS & NOTES

44

P2-

10P

2-11

P2-

8P

2-7

"IN

AD

VE

RT

EN

T O

FF

"LE

D 4

P2-

4P

2-9

"HIG

H P

RE

SS

UR

E"

LED

3

"LO

W P

RE

SS

UR

E"

LED

2

"RE

PLA

CE

BA

TT

ER

Y"

LED

1

"LO

W D

ISA

BLE

"

ON

S2

P2-

6

P2-

5

P2-

3

P2-

2

P2-

1

AP

M L

ED

WIR

ING

DIA

GR

AM

S1

"ON

/OF

F"

ON

OF

F

ON

OF

F

SECTION VII


WARNINGS (Continued)

• Only qualified personnel should set up and operate the Airway PressureMonitor.

• Use only smooth lumen transparent tubing with a 1/8 inch (.317 cm) I.D.and thick walls for the proximal pressure line. Use of non-transparenttubing may allow tubing blockage without operator awareness. Smoothlumen tubing must be used for a leak-free connection.

• The Airway Pressure Monitor does not give a warning alarm for sustainedairway pressure if that pressure is greater than the LOW SET thresholdand less than the HIGH SET threshold.

• Performance Verification should be performed before each:1. sale or rental of the APM (when used in the home environment) and/

or2. application of the Airway Pressure Monitor.

Refer the unit for service if it fails any portion of the Performance Verifica-tion test.

• Each time a change is made to the circuit configuration, the deliveredpressures and APM settings must be monitored at the patient interfacewith the unit cycling to validate pressure delivery.

• Verify the correct operation of the Airway Pressure Monitor BEFOREUSE when in the vicinity of radio frequency sources such as MagneticResonance Imaging Devices, Diathermy, Electrosurgery, X-Ray Genera-tors, or similar types of equipment.

• Repairs to the APM must be performed by an authorized service center.

• Failure to calibrate the APM every three months may cause failure of theunit to alarm at the desired settings.

SECTION I

43

NO

TE

S:

1. A

LL C

AP

AC

ITA

NC

E V

ALU

ES

AR

E IN

FA

RA

DS

UN

LES

S O

TH

ER

WIS

E S

PE

CIF

IED

.2.

ALL

RE

SIS

TA

NC

E V

ALU

ES

AR

E IN

OH

MS

UN

LES

S O

TH

ER

WIS

E S

PE

CIF

IED

.3.

TH

E E

XA

CT

VA

LUE

OF

C6

MA

Y B

E P

AD

DE

D T

O A

CH

IEV

E S

PE

CIF

IED

TIM

ING

AC

CU

RA

CY

.

AP

M C

IRC

UIT

BO

AR

D S

CH

EM

AT

IC

B V+

H L

HL

HV

LDT

RP

N

C2

100N

R31

250K

R32

10K

R20

100

18

2 3 4

57

6

TP

1C

310

M+

TP

5

T1

MP

SA

64

U2D

LM32

4N 75 6

+ -

R21

2.74

KU

10M

0C80

501 2

456N

.C.

N.C

.N

.C.

U9

ICL7

665

R16

825K

VS

S

VD

D

R15

10K

C8

1N1

U7B

4528

TP

4

1 2 3 5 4

7 6

-CX

SE

L

RE

S-T

R+

TR

Q Q

R18

1M

C9

330P

FR

1946

4K

VS

SV

DD

VS

SV

DD

VS

SV

DD

9 10 6 5 3 2 1 13 12

MO

DE

MR

AR

RS

CT

CR

TC

B A

Q8

TP

2

U6

4541

R25

10K

U3

4541

SE

LV

SS

VS

S

VD

D

VD

D

9 10 6 5 3 2 1 13 12

MO

DE

MR

AR

RS

CT

CR

TC

B A

Q8

R26

27.4

KR

2746

4K

VD

D

C4

2M2

+

R24

1M C5

820P

FR

231M

R22

511K

S5

Low

Dis

able

UP

= 6

0 S

EC

.D

OW

N =

20

SE

C.

SE

LV

SS

VS

S

VD

D

VD

D

9 10 6 5 3 2 1 13 12

MO

DE

MR

AR

RS

CT

CR

TC

B A

Q8

VD

D

U4

4541

TP

12

TP

11

U5

4501

1 2 3 4 11 12 5 6 7 9

VD

DV

DD

VS

SV

SS

VS

SV

SS

1A 2A 3A 4A 1C 2C 1B 2B 3B 4B

13 14 15 10

A0

C0

C0

B0

TP

13

R30

1M

C6

(Not

e 3)

820P

FR

2810

0

C7

1N1

R17

274K

VD

D

U7A

4528

15 14 13 11 12V

SS

+C

X

-CX

RE

S-T

R+

TR

+C

X

TP

3

9 10

Q Q

VS

S

VS

SV

SS

VS

S

TP

9

TP

10

U8A

4013

1 2

4

356 8

12139 11

1 0

PR

D CQQ

CL

U8B

4013

PR

D CQQ

CL

R3

4.75

KR

810

0K

R2

4.75

K

U2B

LM32

4N

R5

4.75

K

R4

4.75

K

R7

100K U

2CLM

324N

10 9 12 13148

TP

7

TP

8

TP

6

+ -+ -

C1

100N

"PU

LSE

D V

DD

"R

11

R12

200K

200K

Hig

h C

alT

rimpo

t

Low

Cal

Trim

pot

R9

1.65

K

U2A

LM32

4N3 2

+ -1

R6

665K

R1

4.75

K

32

41

U1

MP

X10

DP

SECTION VII


CAUTIONS

• US federal law restricts this device to sale by or on the order of aphysician.

• DO NOT apply pressure greater than 120 cm H2O to the Airway PressureMonitor. Pressure in excess of 120 cm H2O will damage the AirwayPressure Monitor.

• DO NOT allow moisture to enter the AIRWAY CONNECTION port.Accumulated water may cause damage.

• It is not necessary to use a proximal pressure line filter for performanceverification.For patient application, the use of a proximal pressure line filter isrecommended.

• DO NOT immerse the Airway Pressure Monitor. DO NOT gas sterilize.DO NOT expose to acetone or other solvents. DO NOT allow liquids toenter the AIRWAY CONNECTION.

• DO NOT put the Airway Pressure Monitor into service if the “ReplaceBattery” Alarm is active. The alarm condition must be resolved beforethe Airway Pressure Monitor is used.

• Use only the recommended battery (9-volt alkaline).

• A transparent proximal pressure line filter should be used if the AirwayPressure Monitor is used with a circuit delivering gas at room tempera-ture. A transparent proximal pressure line filter must be used if theAirway Pressure Monitor is used with a circuit delivering heated, humidi-fied gas.

The filter must be of a type designed for use in proximal pressure lines.Use of a non-transparent filter may allow filter blockage without operatorawareness. Filter resistance should increase minimally when exposedto moisture. To protect the internal pressure sensor, follow the filtermanufacturer’s instructions when connecting the transparent proximalpressure line filter. Inappropriate placement may cause the filter to fillwith water, blocking the proximal pressure line. The proximal pressureline filter should be replaced every time the circuit is replaced or cleaned,or if there is evidence of moisture in the filter.

SECTION I

42

NOTE: The HIGH PRESSURE Alarm will activate if the airway pressureis above HIGH SET. The LOW PRESSURE Alarm will activate ifthe airway pressure is below the LOW SET for over 0.5 seconds.

STEP 9 Set the LOW SET Control to 2. Slowly lower the pressure to 2cm H2O. Observe the alarm activation point. Adjust the ZEROADJUST Potentiometer accordingly.

STEP 10 Repeat Steps 7-9, verifying the alarm activation points throughthe entire range of operation, until the HIGH SET AND LOW SETare correct.

STEP 11 Set the LOW SET Control to 20 cm H2O. Set the DELAYControl fully CCW. Pulse the pressure to check the DELAYtimer (60 ± 5 sec.).

STEP 12 Check the DISABLE function. When S5 is: UP = 60 (± 5) sec., DOWN = 20 (± 2) sec. Adjust the disable function to thedesired position.

STEP 13 Turn the APM OFF. Remove the battery. Use an adjustablepower supply (10.0 VDC max. and note the proper polarity) tosubstitute for the battery. Turn the APM ON. Slowly reduce thepower supply voltage to 6.0 VDC. The REPLACE BATTERYalarm should be on at 6.6 ± .2 VDC. Adjust the VOLT ADJ.potentiometer to set this value. Turn the APM OFF. Removethe connector and replace the battery.

STEP 14 Slowly apply pressure to the pressure port. Verify that theINADVERTENT OFF alarm sounds at 5 (± 1) cm H2O. If not,refer the APM for servicing.

SECTION VII


NOTES

• The suggestions given under Alarm Interpretation are for guidance and forfamiliarizing the operator with the Airway Pressure Monitor. Onlyqualified medical personnel can make the appropriate choices of actionrequired for the patient's safety.

• The maximum recommended distance between the proximal pressurefilter and the point to be monitored is 60 inches (150 cm).

SECTION I

41

VOLTAGEADJUST Pot

LOWDISABLESWITCH

HIGH CALPot

LOW CALPot

S5

STEP 4 Set the front panel controls;

a. Set the HIGH SET Control to maximum (CW - 100 cm H2O).b. Set the LOW SET Control to minimum (CCW - 2 cm H2O).c. Set the DELAY Control to minimum (CCW - 0.5 sec.).

STEP 5 Zero the mechanical pressure gauge with a small slotted screw-driver.

STEP 6 Attach sphygmomanometer bulb or syringe capable of delivering100 cm H2O to the Airway Connection pressure port. Turn theAPM ON.

STEP 7 With the HIGH SET control at 100, slowly apply pressure to thepressure port to produce 0 - 120 cm H2O. Observe the alarmactivation point. Adjust the HIGH CAL potentiometer accordingly.

CAUTION: Do not apply pressure greater than 120 cm H2O to the APM.Pressure in excess of 120 cm H2O will cause damage to theAPM.

STEP 8 With the LOW SET control at 50, slowly lower the pressure to50 cm H2O. Observe the alarm activation point. Adjust theLOW CAL potentiometer accordingly.

SECTION VII


STEP 1 Verify that the contents are complete. The original packagingshould contain the Airway Pressure Monitor, and Operation/Service Manual.

STEP 2 Visually inspect the pressure sensing port, labeled “AIRWAYCONNECTION,” on the rear of the APM to verify that it is cleanand unobstructed.

STEP 3 Visually inspect the APM for any damage.

STEP 4 Visually inspect the PRESSURE GAUGE on the front of theAPM. If the needle is outside of the range from +5 cm to -5 cmH2O, the APM may have been damaged. Follow the procedurefor “Pressure Gauge Zero Adjustment” in Section IV, OperationalMaintenance. If the PRESSURE GAUGE cannot be calibrated,notify the sender.

STEP 5 Notify the sender of any damages or shortages and the possiblecause (container damage, etc.).

The Airway Pressure Monitor comes with a 9V alkaline battery included.To replace the battery, see the section on “Battery Replacement.”

RECEIVING INSPECTION

BATTERY INSTALLATION

SECTION II

40

Subsection 3

U9 is an analog voltage detector I.C. (ICL7665), one half of which is usedto monitor battery condition. It is active only when the APM is turned ON.The voltage divider (R31) allows setting the alarm switching point to 6.0VDC to indicate the need for battery replacement. Note that this is theboard voltage. The battery voltage is approximately 0.6 Volts greater.Note that the U3 RC network may have values for R of 1.0M (60 sec.) or333K (20 sec.) as selected by the PCB switch S5.

Complete calibration is recommended before each patient set-up and onceeach year. The ZERO ADJUST, HIGH CAL, and LOW CAL potentiometersprovide an adjust level with a wide ranging adjust network to allow calibra-tion after component aging or replacement. The voltage drops across thisnetwork set the range of adjustment of the LOW SET and HIGH SETpotentiometers to levels equivalent to airway pressures of 2 - 50 cm and 2 -100 cm H2O respectively. As the current path is through the HIGH CAL,LOW CAL, and ZERO ADJUST potentiometers, changing one potentiom-eter will affect the voltage drops through the others. Use a calibrateddigital manometer or a water column manometer to verify the pressuregauge readings.

Warning: Failure to calibrate the APM every three months may causefailure of the unit to alarm at the desired settings.

Caution: Electronic components used in this unit are subject to damageby static electricity. Use proper static discharge and groundingprecautions when servicing the equipment. Service only in astatic-free area.

STEP 1 Remove the TOP cover of the APM by first removing the twoscrews from the bottom of the APM and then gently lifting thetop cover.

STEP 2 Test the battery voltage on the battery clip with a Digital VoltMeter (DVM) (9 VDC nom.).

STEP 3 Locate the PCB potentiometers:Low Cal: Near U2 Pin 1 (LM324)High Cal: Near U2 Pin 14 (LM324)Volt. Adj.: Near U9 Pin 5 (ICL7665)

CALIBRATION

SECTION VII


FRONT PANEL

AIRWAYPRESSUREMONITOR

ON

OFF

LOWDISABLE

LOWSET

HIGHSET

DELAY

HIGHPRESSURE

LOWPRESSURE

INADVERTENTOFF

REPLACEBATTERY

®

80

60

0

40

20 -20

100120

CENTIMETERS OF WATER

POSITIVE NEGATIVE

2

105020

30 40

2

20

10040

60 80

ON

OFF

POWER CONTROL SWITCH

Description: ON/OFF Control (in combinationwith INADVERTENT OFF alarm).

Purpose: ON position enables all of thealarms to be active; OFF positiondisconnects the power except to theINADVERTENT OFF circuit. OFFposition also restarts delay time andresets low disable timers.

INADVERTENT OFF ALARM

Description: Alarm indicator light accompanied byan alarm tone. Activates instantly.

Purpose: To warn the operator of an unsatisfac-tory condition, (e.g., the pressuresensed at the monitored point is abovethe preset threshold while the powercontrol switch is in the OFF position).Activates from a preset internal thresh-old of +4 to +6 cm H2O.

SECTION III

DESCRIPTION OF CONTROLS

INADVERTENTOFF

39

The following service information is provided for conformance with varioushospital, accreditation agency, and government regulations. For thepurpose of illustration, the Airway Pressure Monitor is made up of threeelectronic subsections on the main printed circuit board:

1. Circuitry that converts airway pressure to a pulsed analog voltagewhich is then compared to preset pulsed analog levels represent-ing high and low pressure alarm points.

2. Digital circuitry that latches the output of the comparators, triggersappropriate delays, and generates visible and audible alarms.

3. Analog circuitry that protects the unit from reversed batterypolarity and signals when battery replacement is required.

Subsection 1

U6 is a CMOS 14541 timer I.C. oscillating at 2840 Hz. in the astablemode. An 11 Hz. output (pin 8) triggers U7A and U7B, a CMOS 14528dual monostable I.C.U7B generates a 600 uSec. wide negative pulse (pin7) every 91 mSec. which drives T1 to generate a “pulsed Vdd.” Thepressure transducer U1, the quad op amp U2, and the level adjust networkare all powered from this pulsed Vdd. The pulsed output from U2B (pin 8)indicates when airway pressure is above HIGH SET. The pulsed outputfrom U2C (pin 14) indicates when airway pressure is above LOW SET.U7A generates a 300 uSec. wide negative pulse every 91 mSec. (pin 9) tolatch circuitry in subsection 2.

Subsection 2

U8 is a CMOS 14013 dual D Flip Flop that latches the state of the com-parator outputs (U2B, C) via a positive edge pulse from U7A. If the ampli-fied transducer signal is greater than “HIGH SET”, U8 (pin 2) sinks currentthrough the “HIGH PRESSURE” LED and the audio alarm. If the trans-ducer signal is greater than “LOW SET,” U8 (pin 13) goes high to reset U4.U4 is a CMOS 14541 timer operating in the monostable mode (DELAY 0.5-60 sec.) which inhibits the output of U5 (pin 15), a CMOS 14501 gate, frombeing activated by the output from U4 (pin 8).

CIRCUIT DESCRIPTION

SECTION VII


HIGH SET CONTROL

Description: HIGH PRESSURE alarm thresholdcontrol.Range: 2 - 100 cm H2O

Purpose: To set the HIGH PRESSURE alarm atthe maximum acceptable pressure atthe monitored point.

HIGH PRESSURE ALARM

Description: Alarm indicator light accompaniedby an alarm tone. Activatesinstantly.

Purpose: To warn the operator of an unsatisfac-tory pressure condition. Will soundand light only while the pressuresensed at the monitored point isabove the threshold indicated by theHIGH SET control. Self-cancels atthe end of each alarm condition. Canonly be silenced by correction ofalarm condition or resetting of HIGHSET alarm threshold.

LOW SET CONTROL

Description: LOW PRESSURE alarm thresholdcontrol.Range: 2 - 50 cm H2O

Purpose: To set the LOW PRESSURE alarm atthe minimum acceptable pressure atthe monitored point.

HIGHSET 2

20

10040

60 80

HIGHPRESSURE

LOWSET

2

10

5020

30 40

SECTION III

38

Servicing of the Respironics Airway Pressure Monitor should only beperformed by qualified personnel. By referring to the following schematicand circuit description, sufficient information is provided for calibration ofthe unit.

CAUTION: Respironics, Inc. reserves the right to conduct all AirwayPressure Monitor repairs. Any field repair attempted may voidthe warranty. Field calibration of the unit may be conducted atservice centers equipped with static protected work stations.If service is required, contact Respironics, Inc. directly at:

RESPIRONICS INC.1001 Murry Ridge Lane

Murrysville, Pennsylvania15668 USA

Technical Service: 800-345-6443International Customer Service: 1-724-387-4000

SERVICE

SECTION VII


LOW PRESSURE ALARM

Description: Alarm indicator light accompa-nied by an alarm tone. Activatesbased on the DELAY setting.

Purpose: To warn the operator of an unsatis-factory pressure condition. Willsound and light only while thepressure sensed at the monitoredpoint is below the threshold indicatedby the LOW SET control for theinterval set by the DELAY control.Self-cancels at the end of each alarmcondition. Can be temporarilysilenced by LOW DISABLE. Canonly be silenced by correction ofalarm condition or resetting of LOWSET alarm threshold.

DELAY CONTROL

Description: Variable delay from minimum (0.5sec.) to maximum (60 sec.).Cannot be turned OFF or set forless than 0.5 seconds.

Purpose: To prevent the LOW PRESSUREalarm indicator light and alarm tonefrom turning ON until the low pres-sure condition lasts longer than theselected DELAY setting.

LOWPRESSURE

DELAY

SECTION III

37

BPM breaths per minute

cm centimeter

cm H2O centimeter(s) of water

CMV Continuous Mandatory Ventilation

CPAP continuous positive airway pressure

CW clockwise

CCW counterclockwise

CO2 carbon dioxide

IMV Intermittent Mandatory Ventilation

in inch (1 in. = 2.54 cm)

I.D. internal diameter

kg kilogram (1 kg = 2.20458 pounds)

LED light emitting diode

LIP low inspiratory pressure

LOP loss of pressure

lpm liters per minute

APM Airway Pressure Monitor

PEEP positive end expiratory pressure

PIP peak inspiratory pressure

PS Pressure Support

sec second(s)

GLOSSARY

SECTION VI


LOW DISABLE CONTROL

Description: Push button control. Rangeselected by internal (20/60 sec.)switch.

Purpose: To disable the LOW PRESSUREindicator light and alarm tone. Effec-tive for 20/60 seconds unless manu-ally reset by turning the power controlswitch OFF and then ON again. TheDISABLE period can be extended bydepressing the push button near theend of the 20/60 second period. TheDISABLE period cannot be extendedby repeated activation of the DISABLEcontrol (i.e., depressing the controltwice in sequence does not double theDISABLE period).

REPLACE BATTERY WARNING

Description: Continuous alarm indicator lightand alarm tone. Activates in-stantly.

Purpose: To warn the operator that the batteryvoltage is below the recommendedoperating level (6.6 volts). Can only besilenced by either replacing ordisconnecting the battery or turningthe APM OFF.

LOWDISABLE

REPLACEBATTERY

SECTION III

36

Remote Out: Optically Isolated semiconductor switch (not applicable tohome care). Allows connection to Monaghan®* MedicalCM 5000R Remote Indicator, and the Monaghan MedicalCM 7000 Central Monitoring Station.

Operating Temperature: 60 to 95° Fahrenheit (16° - 35° Celsius)Operating up to 95% Relative HumidityNon-condensing

Storage/Transport Conditions: -40° C to 60° C (-40° F to 140° F), 10%to 100% RH, Condensing.

* Monaghan is a registered trademark of Monaghan Medical Corporation

SECTION VI


PRESSURE GAUGE &CALIBRATION PORT

Description: Pressure gauge with calibra-tion port which allows accessto set screw.

Purpose: Pressure Gauge displays circuitpressure. Set screw allows thegauge to be mechanically zeroed.

Caution: Do not apply pressure greater than120 cm H2O to the AirwayPressure Monitor. Pressure inexcess of 120 cm H2O will dam-age the Airway Pressure Monitor.

80

60

0

40

20 -20

100120

CENTIMETERS OF WATER

POSITIVE NEGATIVE

SECTION III

35

Dimensions: 7.5 x 6.0 x 4.0 in (19 x 15 x 10 cm)

Weight: 34 oz (1.0 kg)

Pressure Gauge: -30 to +120 cm H2O

Pressure Gauge Mechanical Zero: ± 5 cm H2O

LOW SET: +2 to +50 cm H2O

LOW SET Accuracy: ± 2.5 cm H2O

HIGH SET: +2 to +100 cm H2O

HIGH SET Accuracy: ± 5.0 cm H2O

DELAY: 0.5 to 60 seconds

DELAY Accuracy: ± 10% of setting

LOW DISABLE:Internal adjustment; 20 or 60 seconds

Power Source: 9-volt alkaline battery

Battery Life: Expected minimum operating life 8 - 12 weeks continuousoperation with occasional alarm activation.

Replace Battery Warning: Activates when the battery discharges to 6.6(± 0.2) VDC. Capable of remaining activatedfor approx. 8 hours before depleting batterylife.

Audible Tone: Approximately 64 db(A) @ 2 ft., on axis, at 2900 ± 500 Hz.

Electrical: CSA Standard C22.2 No. 125 Certification; Risk Class 2.

SPECIFICATIONS

SECTION VI


ZERO ADJUST CONTROL

Description: Recessed port accessed with 3/16 inch or smaller screwdriver.

Purpose: Allows adjustment of the pressurerange minimum for both the LOW andHIGH SET controls. Allows user tocompensate for electronic drift due tocomponent aging.

AIRWAY CONNECTION PORT

Description: Barbed fitting.

Purpose: Attach proximal pressure line here.Clear, thick walled tubing with an I.D.of 1/8 inch (.317 cm) is recom-mended. DO NOT use thin-walled,oxygen tubing.

REAR PANEL

AIRWAYCONNECTION

REMOTE OUT

ZEROADJUST

COMPATIBLE WITH CM7000CENTRAL MONITORING SYSTEM

ZEROADJUST

AIRWAYCONNECTION

SECTION III

34

CAUTION: Do not allow the pressure gauge to exceed 120 cm H2O whileapplying pressure.

STEP 6 If the alarm points are out of calibration (± 3.0 cm H2O for LOWSET, ± 5 cm H2O for HIGH SET), adjustment is necessary.Insert a narrow bladed screwdriver into the ZERO ADJUSTCONTROL on the rear of the unit. Slowly turn clockwise to raisethe alarm points and counterclockwise to lower them.

a. Adjust LOW SET to 5 cm H2O and apply 0 - 7.5 cm H2O.Adjust the ZERO ADJUST CONTROL so that the LOWPRESSURE alarm function is triggered within specifications.

b. Repeat Steps 5 and 6 until HIGH and LOW SET are correct.If adjustment of the ZERO SPAN will not correct HIGH/LOWset, recalibration is needed. Refer to the Calibration proce-dure.

STEP 7 Verify with a calibrated digital manometer or a water columnmanometer. Compare this with the APM gauge manometer. Ifthere is an error of more than 5 cm H2O, the gauge will need tobe replaced. Refer the APM for servicing.

SECTION V


REMOTE OUT REMOTE OUT CONNECTION

Description: Optically isolated semiconductorswitch (not applicable to homecare).

Purpose: Allows connection to the Monaghan®

Medical CM 5000R Remote Indicator.Remote Out allows connection to theMonaghan® Medical CM7000 CentralMonitoring System, if indicated on theAPM unit.

AUDIO INDICATOR

Description: Audio outlet port.

Purpose: Source of audible tone for alarmconditions.

BATTERY COMPARTMENT

Description: Where battery is connected.

Purpose: To secure battery for safe operation.Use only 9-volt alkaline batteries.

SECTION III

33

c. After adjustment of Zero Span, repeat Steps 1 & 2 above. Ifadjustment of Zero Span failed to correct the condition, theAPM must be referred for servicing.

STEP 3 Gradually increase circuit pressure above 10 cm H2O, observingthe pressure gauge reading. Compare the gauge reading to theHIGH SET at the moment the HIGH PRESSURE warning alarmsare activated. Repeat by gradually decreasing the pressure todeactivate the alarms.

a. If the APM performs within specification, the unit may be putinto service. If there appears to be a discrepancy greater than± 5 cm H2O between the HIGH SET and the gauge reading atthe point of alarm, adjust the Zero Span setting of the APMper the procedure following this section.

b. After adjustment of Zero Span, repeat Step 3a above. Ifadjustment of Zero Span failed to correct the condition, theAPM must be referred for servicing.

WARNING: If the APM fails to operate as specified, refer it for servicing.Using a monitor that is not operating properly may allow apatient's ventilation problem to go undetected.

Perform Sensing Accuracy Check. If the unit fails, perform Zero SpanAdjustment.

STEP 1 Install a new battery into the battery compartment.

STEP 2 Set front panel controls: HIGH SET: maximum, 120 cm H2OLOW SET: maximum, 50 cm H2ODELAY: minimum, 0.5 sec.

STEP 3 Zero mechanical gauge per instructions in Section IV, Opera-tional Maintenance.

STEP 4 Attach sphygmomanometer bulb or syringe capable of delivering120 cm H2O.

STEP 5 Turn the APM ON. Slowly apply pressure up to 0 - 120 cm H2Oto view the alarm activation points.

SECTION V

ZERO SPAN ADJUSTMENT


A clear, transparent tubing of 1/8 inches (0.125 inches) internal diameter withthick walls is recommended for use with the APM. A short 6 inch (15 cm)length of tubing is to be used between the filter and the pressure port. Themaximum recommended length between the filter and the point to be moni-tored is 60 inches (150 cm).

A clear and transparent bacteria filter that connects to the tubing withoutleaking is recommended for use with the APM.

WARNING: DANGER - Explosion Hazard. DO NOT USE in the presenceof flammable anesthetics.

WARNING: Use only smooth lumen transparent tubing with 1/8 inch(.317 cm) I.D. with thick walls for the proximal pressure line.Use of non-transparent tubing may allow tubing blockagewithout operator awareness. Smooth lumen tubing must beused for a leak-free connection.

WARNING: Only qualified personnel should set up and operate the APM.

WARNING: • A transparent proximal pressure line filter should be used ifthe Airway Pressure Monitor is used with a circuit deliveringgas at room temperature. A filter must be used if the AirwayPressure Monitor is used with a circuit delivering heated,humidified gas.

• The transparent proximal pressure line filter must be of atype designed for use in proximal pressure lines. Use of anon-transparent filter may allow filter blockage withoutoperator awareness.

• The transparent proximal pressure line filter resistance mayincrease minimally when exposed to moisture.

• The transparent proximal pressure line filter must beconnected close to the Airway Pressure Monitor to protectthe internal pressure sensor. Inappropriate placement maycause the filter to fill with water, blocking the proximalpressure line.

• The transparent proximal pressure line filter should bereplaced every time the circuit is replaced or cleaned, or ifthere is evidence of moisture in the filter.

MONITOR CONNECTIONS

SECTION III

RECOMMENDED TUBING AND FILTER

32

With the proximal pressure line disconnected from the APM, the APMneedle should point to “0.” To adjust the needle position, first remove thecap from the calibration port at the top of the APM crystal (front cover).Carefully insert a small, flat screwdriver through the hole and slowly turnthe adjustment screw to obtain a zero reading. Do not over adjust;maximum adjustment range is approximately ± 5 cm H2O. Replace theport cap.

At the end of product life, dispose of APM in accordance with local regula-tions.

DISPOSAL

PRESSURE GAUGE ZERO ADJUSTMENT

This check is performed to ensure that the LOW SET alarm points areaccurate to within stated accuracy when compared to the actual gaugereading at the point of alarm. Before performing this function, verify thatthe pressure gauge is properly zeroed.

STEP 1 Set the DELAY Control to minimum, HIGH SET to 10 cm H2O,and the LOW SET to 5 cm H2O.

STEP 2 Turn the APM ON and pressurize the circuit to a level lower thanthe LOW SET point. The audible and visual alarm indicatorsshould be active. Gradually increase circuit pressure, observingthe pressure gauge reading. Compare the gauge reading to theLOW SET at the moment the LOW PRESSURE warning alarmceases. Repeat by decreasing circuit pressure to cause theLOW PRESSURE alarm to reactivate.

a. Activate LOW DISABLE. Set DELAY to maximum and LOWSET to minimum.

b. If the APM performs within specification, proceed to Step cand continue with check. If there appears to be a discrep-ancy of greater than ± 3.0 cm H2O between the LOW SETand the gauge reading at the point of alarm, adjust the ZeroSpan setting of the APM per the procedure following thissection.

SECTION V

SENSING ACCURACY CHECK


WARNING: • For Performance Verification it is not necessary to use atransparent proximal pressure line filter. For patient applica-tion, the use of a proximal pressure line filter is recom-mended.

• The maximum recommended length between the transpar-ent proximal pressure line filter and the point to be moni-tored is 60 inches (150 cm).

CAUTION: DO NOT apply pressure greater than 120 cm H2O to theAirway Pressure Monitor. Pressure in excess of 120 cm H2Owill damage the Airway Pressure Monitor.

When installing the Airway Pressure Monitor, follow the instructionsprovided with the specific mounting method chosen and observe thefollowing considerations:

• The APM must be positioned as to be clearly visible to the caregiver and/or patient.

• The APM must be securely mounted.• The APM must be situated within 60 inches (150 cm) from the point where

the pressure is being monitored.• For the most accurate reflection of the patient's ventilating environment,

the pressure line should be connected proximal to the patient airway(e.g., mask port).

• In order to minimize problems with condensation when in-line humidifica-tion is used, the monitored point should be at least 10 inches (25.4 cm)lower than both the APM and the filter at all times.

Before installation, check the 5000S APM for operation as follows:

NOTE: This procedure may be used to check a new APM or one that hasbeen stored. If new, the battery must be installed to the unit.

STEP 1 If the APM was received from the factory, install the battery asinstructed in the Battery Installation section.

STEP 2 Turn the DELAY knob fully counterclockwise until set to 2seconds.

STEP 3 Turn the LOW SET knob fully counterclockwise until set to 2 cmH2O.

PRE-INSTALLATION CHECKOUT

SECTION III

31

Whenever the APM is removed from active service for extended periods oftime (e.g., 10 days or more), prepare it for storage according to thefollowing guidelines.

STEP 1 Disconnect and dispose of the proximal pressure line and filter.

STEP 2 Verify that the Power Control Switch is OFF.

STEP 3 If storing for an indefinite period, remove the battery to preventpossible damage from leakage of the cell.

STEP 4 Seal the AIRWAY CONNECTION Port with plastic tape.

STEP 5 Place the APM in a plastic bag.

STEP 6 Store in a clean, dry area. The temperature and humidity shouldbe maintained within the storage/transport conditions specifiedper Section VI.

CAUTION: Use only the recommended battery (9-volt alkaline).

STEP 1 Open the door of the battery compartment on the rear panel ofthe APM. The door is secured with a locking tab and may takeslight force to open.

STEP 2 Disconnect the battery by grasping the connector and thebattery. Do not try to disconnect the battery by pulling on thewires.

STEP 3 Fasten a 9-volt alkaline battery to the connector.

STEP 4 Place the new battery into the battery compartment. Close thecompartment door securely, ensuring that the locking tab isengaged.

Dispose of old battery in accordance with local regulations.

STORAGE

BATTERY REPLACEMENT

SECTION V


SECTION III

STEP 4 Turn the HIGH SET knob fully clockwise until set to 100 cm H2O.

STEP 5 Turn on the APM.

STEP 6 If the REPLACE BATTERIES indicator illuminates and the audiblealarm sounds, turn off the unit. Check the battery and/or install anew battery as instructed in the Battery Replacement section.

STEP 7 If the LOW PRESSURE indicator does not illuminate and theaudible alarm does not sound, leave the unit on and wait for twoseconds (as set by the DELAY knob). Since the pressure port atthe rear of the APM is not connected to a source of pressureabove atmospheric, the LOW PRESSURE indicator illuminatesand the audible alarm sounds.

STEP 8 If the alarm indicators specified in step 7 fail to occur, turn off theunit. Check the battery and/or install a new battery as instructed inthe Battery Replacement section, and repeat Steps 2 through 8.

WARNING: If the LOW PRESSURE test still fails, do not use the 5000SAPM. Return the unit for servicing.

STEP 9 When Step 7 successfully produces both the visual and audioalarms, connect a 6 inch (15 cm) length of tubing to the pressureport marked “AIRWAY CONNECTION” on the rear panel. Useonly the recommended tubing as suggested in the Recom-mended Tubing and Filters section.

STEP 10 Connect the bacteria filter to the other end of the 6” tube. Useonly recommended filter as suggested in the RecommendedTubing and Filters section.

STEP 11 Attach a long pressure sensor tube to the filter inlet side (markedINLET). Use only the recommended tubing as suggested in theRecommended Tubing and Filters section. The maximum lengthof tubing that may be used is 60 inches (150 cm).

STEP 12 With the APM off, carefully apply pressure to the pressuresensor tube. Observe the manometer of the APM while slowlyincreasing the pressure from 0 to 10 cm H2O. A ventilator with atest lung, or a manually controlled syringe is an acceptablepressure source.

30

The Airway Pressure Monitor is designed to give long and reliable servicewith a minimum of maintenance. However, because of the serious nature ofthe situations in which the APM is used routine maintenance is essential.

At minimum, the following periodic checks and procedures are required toensure continued, reliable service:

1. Before use with a new patient, clean per Section V. Install a cleanproximal pressure line and bacteria filter per Preoperational Check,Section IV.

2. Perform a Sensing Accuracy Check per Section V before each patientsetup and once each month as part of routine maintenance.

3. Before restarting equipment after overnight shutdown, clean perSection V and perform Preoperational Check per Section IV.

4. When the REPLACE BATTERY warning is activated, change batteryimmediately per Section IV.

5. Perform CALIBRATION PROCEDURE before each patient set-up andonce each year as part of routine maintenance.

Using a cloth slightly dampened with water and a mild detergent, alcohol,or bactericidal agent, wipe the outside of the APM. All other parts of theAPM system are disposable (tubing and filters). The length of time acircuit is used should be determined by the appropriate personnel basedon accepted infection control procedures. The APM should be cleanedbefore each patient setup and once each year as part of routine mainte-nance.

CAUTION: DO NOT clean the APM by steam autoclave or gas steriliza-tion. DO NOT clean any parts of the APM with acetone orother solvents. DO NOT immerse the APM or allow any liquidto enter the Airway Connection Port.

CLEANING

SECTION V

OPERATIONAL MAINTENANCE

PERIODIC CHECKS


CAUTION: Do not attach a high pressure source to the pressure port ofthe APM. Pressure in excess of 120 cm H2O will damage theunit. Do not allow moisture to enter the pressure port. Accu-mulated water may cause damage.

STEP 13 With the APM off, note the rising pressure indicated on themanometer. When the indicated pressure exceeds the presetlevel of 4 to 6 cm H2O, the INADVERTENT OFF indicatorilluminates and the audible alarm sounds.

WARNING: If this test is not successful, do not use the 5000S APM.Return the APM for servicing.

STEP 14 Turn on the APM, and slowly reduce the pressure to less thanthe LOW SET level. After the DELAY period, the LOW PRES-SURE indicator illuminates and the audible alarm sounds.

a.Check that the minimum LOW SET level is set from 2 to 3 cmH2O (turn the knob fully counterclockwise).

b.Turn the LOW SET control to maximum (fully clockwise) andapply 60 cm H2O. Slowly reduce the pressure.

c.Check that the maximum LOW SET level is set to 50 cm H2O.

STEP 15 Using a stopwatch, time the DELAY period when the pressuredrops below the LOW SET level to when the LOW PRESSUREalarm sounds.

a.Check that the minimum DELAY time is 2 seconds.

b.Turn the DELAY knob fully clockwise and check that themaximum DELAY time is 60 seconds.

c.Turn the DELAY knob fully counterclockwise.

STEP 16 Increase the pressure to greater than the LOW SET level andthe LOW PRESSURE alarm ceases.

SECTION III

29

NOTE: The suggestions given are for guidance and for familiarizing theoperator with the APM. Only a trained caregiver can make theappropriate choices of action required for the patient's safety.

ALARM INTERPRETATION

SECTION IV

Warning Indication

INADVERTENT OFF

HIGH PRESSURE

LOW PRESSURE

REPLACE BATTERY

Meaning

APM power controlswitch is off whilepressure is sensed.

Pressure is sensed atmonitored location isgreater than the HIGHSET threshold.

Pressure is sensedat monitored locationis less than the LOWSET threshold for aperiod that exceedsthe DELAY CONTROLsetting.

Battery voltage is lessthan the allowablelevel.

Suggested Action

Turn APM on. APM shouldremain on at all times whenproximal pressure line is in anactive circuit.

1. Asses the patient.2. Check the ventilator system.3. Check the HIGH SET

threshold setting of the APM.4. Check the proximal pres-

sure line from the APM to themonitored point for conden-sation, blockage or otherimpairment.

5. If the problem persists whilethe patient and ventilator areotherwise satisfactory, referthe APM for servicing.

1. Asses the patient.2. Press LOW DISABLE.3. Check the ventilator system.4. Check the LOW SET thresh-

old and the DELAY settingsof the APM.

5. Check the proximal pres-sure line from the APM to themonitored point for discon-nection, leakage condensa-tion, blockage or other im-pairment.

6. If problem persists whilepatient and ventilatorsystem are otherwisesactisfactory, refer the APMfor servicing.

1. Replace Battery.2. If the problem persists after

installing a new battery, re-fer the APM for servicing.


STEP 17 Continue to increase the pressure (maximum 120 cm H2O);

a.If the manometer pressure is greater than the HIGH SET level(100 cm H2O) then both the HIGH PRESSURE indicatorilluminates and the audible alarm sounds.

b.If the manometer pressure is less than the HIGH SET levelthen both the HIGH PRESSURE indicator shuts off and theaudible alarm ceases immediately.

WARNING: If steps 14 to 18 are not successful do not use the 5000SAPM. Return the APM for servicing.

STEP 18 Reduce the pressure to less than the LOW SET level andmaintain for the DELAY period of two seconds. When the LOWPRESSURE indicator illuminates and the audible alarmsounds, press the LOW DISABLE switch. Both the LOWPRESSURE indicator turns off and the audible alarm ceasesfor an internally preset interval of either 20 or 60 seconds, (thefactory setting is 20 seconds). Check that the disable periodrequired has been selected by accurately timing the LOWDISABLE period.

WARNING: If the LOW DISABLE interval time is not what is expected bythe medical attendant, then return the APM for servicing.

Both the LOW PRESSURE indicator illuminates and theaudible alarm sounds after the LOW DISABLE interval unlessthe pressure increases to greater than the LOW SET level.

The 5000S APM is intended for use in conjunction with lung ventilatorsystems that operate in the 0 - 120 cm H2O pressure range.

WARNING: To avoid the risk of fire or explosion, do not use the 5000SAPM in the presence of flammable gases, anesthetics, etc.

Installation of the 5000S involves two considerations;

a. Placing the unit in a secure and convenient location for the unitthat is clearly visible to attendants.

b. Connecting the unit to the point at which pressure is to be sensed.

The following instructions detail these considerations:

SECTION III

INSTALLATION INSTRUCTIONS

28

STEP 7 Proceed with ventilation operation, reacting to any 5000Swarning alarms as suggested in the Alarm Interpretationsection.

WARNING: Verify the correct operation of the 5000S APM during extendedoperation of the unit by repeating Steps 4 through 7.

SUGGESTED OPERATIONAL PARAMETERS

LOW PRESSURE

Application

Controlled ventilationCMVIMVCMV with PEEPIMV with PEEPAssist ventilationPressure Support

CPAPPEEP

DELAY Selection

Not less than onebreathing cycle (60 sec./bpm) or longer than asafe period of pressureloss.

LOW SET

Slightly less than thePeak InspiratoryPressure (PIP).*

Not less than one breath-ing cycle (60 sec./bpm) orlonger than a safe periodof pressure loss.

Slightly less than thePeak InspiratoryPressure (PIP).*

HIGH PRESSURE

Application

Controlled ventilationCMVIMVCMB with PEEPIMV with PEEPAssist ventilationPressure Support (PS)

CPAPPEEP

HIGH SET Threshold Selection

Slightly greater than the PeakInspiratory Pressure (PIP).*

Slightly greater than the requiredbaseline pressure.*

SECTION IV

* Initially these pressures may be estimated a few cm H2O on the low side (LOWSET) and a few cm H2O on the high side (HIGH SET). After the system is inoperation, the actual pressures may be observed on the 5000S. The pressurethresholds should then be adjusted accordingly.


The 5000S must be situated in a secure position within 5 feet (1.6 meters)of the point at which the pressure is monitored. In order to minimizeproblems with condensation, the monitored point should be at least 10inches (25.4 cm) lower than both the unit and the filter at all times.

The alarm unit may be placed on a shelf. However, when monitoring aportable system, attach the shelf to the equipment and secure the unit toavoid accidental disconnection of the pressure sensor line. The preferredmethod of installation is to mount the unit on a pole or column attached tothe monitored equipment.

After the 5000S is securely positioned, connect the APM to the point atwhich the pressure is to be monitored. This is usually a point as close to thepatient as possible. Connect the APM as follows:

NOTE: Only qualified personnel should set up the 5000S APM.

STEP 1 Visually check that the “AIRWAY CONNECTION” fitting on therear panel of the unit is clear, clean, and dry.

STEP 2 Connect a 6 inch (15 cm) length of pressure sensor tubing tothis fitting. Use only the recommended tubing as described inthe Recommended Tubing and Filter section.

STEP 3 Connect the outlet side of the bacteria filter to the other end ofthe short pressure sensor tube. This positions the filter nearthe unit. Use only recommended bacteria filters as described inthe Recommended Tubing and Filters section. The filterprotects the internal components of the 5000S.

CAUTION: The filter must be connected close to the 5000S to protect thepressure sensor. Inappropriate placement may cause the filterto fill with water, blocking the pressure sensor tubing.

STEP 4 Connect the pressure sensor tubing to the INLET side of thefilter. Use only the recommended tubing as described in theRecommended Tubing and Filters section no more than themaximum length of 60 inches (150 cm).

LOCATION/MOUNTING

SENSOR HOOKUP

SECTION III

27

STEP 2 Turn on the 5000S APM.

STEP 3 Turn on the ventilator.

STEP 4 Set the LOW SET threshold to the LOW PRESSURE warningas required, e.g. for Assist, Controlled and IMV procedures setthe pressure for LIP; and for PEEP or CPAP set it for LOP, seethe Suggested Operational Parameters section.

Initially these pressures may be estimated a few cm H2O onthe low side of the LOW SET and a few cm H2O on the highside of the HIGH SET. After the system is operating, the actualpressures may be observed on the 5000S APM manometer.Adjust the pressure thresholds accordingly.

WARNING: Pressure thresholds should be set as close to the PIP orbaseline as possible.

WARNING: Verify the accuracy of the LOW SET knob against that of themanometer in the APM by observing the pressure required tocause the LOW PRESSURE warning to cease. If a discrep-ancy is noted, carefully disconnect the unit and replace it witha spare. Using a monitor that is not operating properly mayallow a patient’s ventilation problem to go undetected.

STEP 5 Set the DELAY knob for the maximum acceptable apneic period.

WARNING: Verify the DELAY setting by manually pinching the pressuresensor tubing, causing the pressure to remain less than theLOW SET pressure, while timing the delay period before theLOW PRESSURE warnings activate.

STEP 6 Set the HIGH SET knob for the threshold at which the 5000SHIGH PRESSURE warning is required, e.g. for Assist, Controland IMB procedures, set the pressure for slightly above thePeak Inspiratory Pressure (PIP), and for PEEP or CPAP, set itfor slightly above the baseline pressure.

WARNING: Verify the accuracy of the HIGH SET knob against that of themanometer in the APM by observing the pressure required tocause the HIGH PRESSURE warning to cease. If a discrep-ancy is noted, carefully disconnect the unit and replace it witha spare. Using a monitor that is not operating properly mayallow a patient’s ventilation problem to go undetected.

SECTION IV


STEP 5 Connect the free end of the long pressure sensor tubing to thepoint to be monitored in the patient circuit.

STEP 6 Check the installation by repeating the pre-installation proce-dure.

CAUTION: Use transparent tubing only. Use of non-transparent tubingmay allow tubing blockage without operator awareness.

SECTION III

26

b.If there is no INADVERTENT OFF indicator and audible alarmand the ventilator pressure is over the preset threshold, returnthe 5000S for servicing.

c.If the INADVERTENT OFF indicator illuminates and theaudible alarm sounds, proceed with STEP 4.

STEP 4 Turn on the 5000S.

a.If the REPLACE BATTERIES indicator illuminates and theaudible alarm sounds, replace the battery in accordance withthe Battery Replacement section, and repeat STEP 4. If anew battery does not correct the condition, return the 5000Sfor servicing.

STEP 5 Press the LOW DISABLE switch to disable the LOW pressurealarm.

If the preceding preoperational check meets all requirementsunder the specified conditions, proceed with the RoutineOperation section.

When properly installed and maintained, the operation of the 5000S APMis virtually automatic. After the APM is turned on, the attendant is onlyrequired to interpret and react to warnings provided by the 5000S’s visibleand audio alarms.

The Alarm Interpretation section lists probable causes of most alarms atdifferent times during the ventilation procedure. Responsive actions arealso suggested.

The following procedural sequence is suggested for the orderly operation ofa respiratory support system in which the 5000S APM is used.

STEP 1 Before turning on the equipment, set the parameters of theventilator as required for the intended application, and initiallyset the 5000S parameter to the following settings:

a. Set the LOW SET knob fully counterclockwise (minimum).

b. Set the DELAY knob fully counterclockwise (minimum).

c. Set the HIGH SET knob fully clockwise (maximum).

SECTION IV

ROUTINE OPERATION


All displays and those controls used by the attendant are located on thefront panel of the 5000S APM.

The essential purpose of the 5000S APM is to warn the medical attendantwhenever:

a. Airway pressure drops below a selected lower threshold for anunacceptable length of time.

b. Airway pressure exceeds a selected upper threshold.

Select the minimum acceptable pressure (threshold) by setting the LOWSET knob. The graduation marks on the LOW SET knob represent 5 cm H2Oincrements from 5 - 50 cm H2O with a 2 cm H2O mark at the minimumsetting. Set the LOW SET threshold by aligning the desired pressure on theknob with the mark on the protective guard of the APM.

The knob range is electrically limited by the ZERO ADJUST control on therear panel for the low end (2 cm H2O) and an internal adjustment for thehigh end (50 cm H2O). Refer to the Suggested Operational Parameterssection for suggestions on determining the appropriate LOW alarm thresh-old value.

The DELAY settings correspond to an estimation of an acceptable periodof time during which the pressure may be below the selected threshold.Since the 5000S monitor is a backup device, the DELAY is usually set atthe maximum end of the acceptable period. This minimizes the possibilityof false LOW PRESSURE alarms. However, no general guideline can takethe place of professional evaluation in each patient’s case. The 5000Sprovides a low pressure DELAY range of 0.5 - 60 seconds. Set the delayperiod by using the DELAY knob.

Select the maximum acceptable pressure (threshold) by setting the HIGHSET knob. The graduation marks on the HIGH SET knob represent 10 cmH2O increments from 10 - 100 cm H2O with a 2 cm H2O mark at theminimum setting. Set the HIGH SET threshold by aligning the desiredpressure on the knob with the mark on the protective guard of the APM.

SECTION IV

CONTROLS AND DISPLAYS

MONITORING APPLICATIONS

25

The knob range is electrically limited by the ZERO ADJUST control on therear panel for the low end (2 cm H2O) and an internal adjustment for thehigh end (100 cm H2O). Refer to the Suggested Operational Parameterssection for suggestions on determining the appropriate HIGH alarmthreshold value.

Conduct the following procedure before using a ventilator that is equippedwith a 5000S series APM. It is assumed that the 5000S has been installedand connected to the ventilator as instructed in Section III. Complete thefollowing procedure before turning on the ventilator.

WARNING: If the unit fails to operate as specified in this procedure,disconnect the APM from the ventilator and replace it with aspare. Using any monitor that is not operating properly mayallow a patient’s ventilation problem to go undetected.

STEP 1 Verify that the pressure sensor tubing to the 5000S is clean,dry and is free of kinks and loops. If not, correct the condition.Refer to the Sensor Hookup section.

NOTE: If the ventilator has been activated, skip to STEP 3.

STEP 2 With the ventilator off, turn on the 5000S APM. If the REPLACEBATTERIES indicator illuminates and the audible alarmsounds, replace the battery in accordance with the BatteryReplacement section, and repeat STEP 2. If a new batterydoes not correct the condition, return the 5000S for servicing.

If there is no immediate visible or audible alarm, proceed toSTEP 3.

STEP 3 With the ventilator running and connected to a patient or testlung, turn off the APM. The INADVERTENT OFF indicatorilluminates and the audible alarm sounds to signify that themonitored pressure is over the preset threshold while the5000S is off.

a.If there is no INADVERTENT OFF indicator and audiblealarm, verify that there is normal ventilator pressure at themonitored point is present. If not, check the ventilatoroperation.

SECTION IV

PREOPERATIONAL CHECK

Documents

Service Manual APM 235288500