Nellcor N-3100 Service manual

SERVICE MANUAL

NELLCOR SYMPHONY

®

N-3100 Blood Pressure Monitor

To contact Nellcor Puritan Bennett’s representative: In the United States, call 1-800-NELLCOR or 510 463-4000; outside the

United States, call your local Nellcor Puritan Bennett representative.

Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.

© 1998Nellcor Incorporated. All rights reserved. 034134B-0298

Corporate Headquarters

Regional/Local Offices

Nellcor Puritan Bennett Inc.
4280 Hacienda Drive
Pleasanton, California 94588 U.S.A.
Tel. [phone] or
1-800-NELLCOR
Fax [phone]

U.S. Service Repair Center

Nellcor Puritan Bennett Inc.
2200 Faraday Avenue
Carlsbad, California 92008
U.S.A.
Tel. [phone]

European Office

Nellcor Puritan Bennett Europe BV
Hambakenwetering 1
5231 DD ’s-Hertogenbosch
The Netherlands
Tel. [phone]

Asia/Pacific Office

Nellcor Puritan Bennett HK Ltd.
Room 1602 Evergo House
38 Gloucester Road
Wanchai
Hong Kong
Tel. [phone]

Nellcor Puritan Bennett UK Ltd.
10, Talisman Business Centre
London Road
Bicester
Oxfordshire OX6 0JX
United Kingdom
Tel. [phone]

Nellcor Puritan Bennett Belgium
NV/SA
Interleuvenlaan 62/8, Zone 2
B-3001 Heverlee
Belgium
Tel. [phone]

Nellcor Puritan Bennett France
3 Avenue du Canada, Bâtiment
Sigma
LP851
91975 Courtaboeuf Cedex
France
Tel. [phone]

Nellcor Puritan Bennett Germany
GmbH
Black-&-Decker-Strasse 28
65510 Idstein
Germany
Tel. [phone]

Nellcor Puritan Bennett Italia
Via Edison, 6
20090 Assago (MI)
Italy
Tel. [phone]

Nellcor Puritan Bennett Finland Oy
Kappelitie 8
02200 Espoo
Finland
Tel. [phone]

To obtain information about a warranty, if any, for this product, contact Nellcor
Puritan Bennett’s Technical Services Department or your local Nellcor Puritan
Bennett representative.

NELLCOR SYMPHONY and the Nellcor knob configuration are trademarks of Nellcor
Puritan Bennett Inc.

TABLE OF CONTENTS

List of Figures
List of Tables

Section 1: Introduction

1.1 Manual Overview.......................................................................... 1-1

1.2 Warnings, Cautions, and Notes.................................................... 1-1

1.2.1 Warning........................................................................... 1-1

1.2.2 Caution............................................................................ 1-1

1.2.3 Note................................................................................. 1-1

1.3 N-3100 Blood Pressure Monitor Description ................................ 1-1

1.4 Related Documents...................................................................... 1-2

Section 2: Routine Maintenance

2.1 Cleaning ....................................................................................... 2-1

2.2 Periodic Safety and Functional Checks........................................ 2-1

2.3 Batteries ....................................................................................... 2-1

Section 3: Performance Verification

3.1 Introduction................................................................................... 3-1

3.2 Equipment Needed....................................................................... 3-1

3.3 Performance Tests....................................................................... 3-1

3.3.1 Power-up......................................................................... 3-1

3.3.1.1 Power-On Self-Test ........................................................ 3-1

3.3.1.2 Power-On Defaults for Adult-Pediatric Alarm Limits

3.3.1.3 Power-On Defaults for Neonatal Alarm Limits

3.3.2 Verification of Pneumatic System ................................... 3-10

3.3.2.1 Pressure Transducer Accuracy....................................... 3-11

3.3.2.2 Pneumatic Leakage —Adult............................................ 3-12

3.3.2.3 Pneumatic Leakage—Neonate....................................... 3-12

3.3.2.4 Cuff Inflation Rate ........................................................... 3-13

3.3.2.5 Cuff Deflation Rate.......................................................... 3-13

3.3.2.6 High-Pressure—Adult ..................................................... 3-14

3.3.2.7 High-Pressure—Neonate................................................ 3-14

3.3.3 Pulse Rate Accuracy Tests............................................. 3-15

3.3.3.1 Pulse Rate Accuracy Test —Adult.................................. 3-15

3.3.3.2 Pulse Rate Accuracy Test —Neonate ............................ 3-16

3.4 Safety Tests ................................................................................. 3-16

3.4.1 Ground Integrity .............................................................. 3-16

3.4.2 Electrical Leakage........................................................... 3-17

3.4.2.1 Earth Leakage Current.................................................... 3-17

3.4.2.2 Patient Leakage Current ................................................. 3-18

3.4.2.3 Patient Leakage Current (MOAP)................................... 3-18

............................................................................... 1-1

................................................................ 2-1

.......................................................... 3-1

and Ranges................................................................. 3-3

and Ranges.................................................................. 3-7

iii

Table of Contents

Section 4: Configuration and Service Modes

........................................... 4-1

4.1 Introduction................................................................................... 4-1

4.2 Configuration Mode...................................................................... 4-1

4.2.1 Adult-Pediatric/Neonatal Mode Default........................... 4-3

4.2.2 Systolic Upper Alarm Limit.............................................. 4-3

4.2.3 Systolic Lower Alarm Limit.............................................. 4-3

4.2.4 Diastolic Upper Alarm Limit............................................. 4-3

4.2.5 Diastolic Lower Alarm Limit............................................. 4-3

4.2.6 Mean Upper Alarm Limit ................................................. 4-4

4.2.7 Mean Lower Alarm Limit ................................................. 4-4

4.2.8 Pulse Rate Upper Alarm Limit......................................... 4-4

4.2.9 Pulse Rate Lower Alarm Limit......................................... 4-4

4.2.10 Alarm Volume ................................................................. 4-5

4.2.11 Alarm Silence Duration ................................................... 4-5

4.2.12 Auto Measurement Cycle Interval................................... 4-5

4.2.13 Configuration Menu......................................................... 4-6

4.3 Service Mode................................................................................ 4-7

4.3.1 Menu Item 1: Software Version Report........................... 4-10

4.3.2 Menu Item 2: Lamp Test Mode....................................... 4-10

4.3.3 Menu Item 3: Button Test Mode...................................... 4-10

4.3.4 Menu Item 4: Speaker Test Mode................................... 4-11

4.3.5 Menu Item 5: Internal Configuration

Code (ICC) Report..................................................... 4-12

4.3.6 Menu Item 6: Total Operating Hours Report................... 4-12

4.3.7 Menu Items 7-16: Error Log Record Report.................... 4-12

4.3.8 Menu Item 17: Instrument Identification (IID) Report ...... 4-13

4.3.9 Menu Item 18: Power and Battery Status Report ........... 4-13

4.3.10 Menu Item 19: Persistent Time Sense Report................ 4-14

4.3.11 Menu Item 20: Reset to Factory Defaults........................ 4-14

4.3.12 Menu Item 21: Initial Cluster Instrument Number

(CIN) Selection.......................................................... 4-14

4.3.13 Menu Item 23: Enable/Disable Alarm

Silence Reminder....................................................... 4-15

4.3.14 Menu Item 24: Pressure Calculation

Algorithm Selection.................................................... 4-15

4.3.15 Menu Item 29: Instrument Compatibility Report.............. 4-16

4.3.16 Menu Item 30: Pressure Transducer

Accuracy Test Mode .................................................. 4-16

4.3.17 Menu Item 31: Inflation Time Test Mode ........................ 4-17

4.3.18 Menu Item 32: Deflation Rate Test Mode ....................... 4-17

4.3.19 Menu Item 33: Adult Leak Test Mode ............................. 4-18

4.3.20 Menu Item 34: Neonate Leak Test Mode........................ 4-18

4.3.21 Menu Item 35: Adult Maximum Pump

Pressure Test Mode................................................... 4-19

4.3.22 Menu Item 36: Neonate Maximum Pump

Pressure Test Mode................................................... 4-19

4.3.23 Menu Item 37: Blood Pressure Module

Self-Check Report...................................................... 4-20

iv

Table of Contents

Section 5: Troubleshooting

5.1 Introduction................................................................................... 5-1

5.2 How to Use this Section ............................................................... 5-1

5.3 Who Should Perform Repairs....................................................... 5-1

5.4 Replacement Level Supported..................................................... 5-1

5.5 Obtaining Replacement Parts ...................................................... 5-1

5.6 Troubleshooting Guide................................................................. 5-2

5.6.1 AC Power........................................................................ 5-3

5.6.2 Error Codes..................................................................... 5-4

5.6.2.1 User-Correctable Error Codes ........................................ 5-4

5.6.2.2 Failure Error Codes......................................................... 5-5

5.6.3 Buttons ............................................................................ 5-7

5.6.4 Display/Alarms ................................................................ 5-7

5.6.5 Operational Performance................................................ 5-8

5.6.6 Stacked Configuration..................................................... 5-8

Section 6: Disassembly Guide

6.1 Introduction................................................................................... 6-1

6.2 Fuse Replacement ....................................................................... 6-1

6.3 Monitor Disassembly .................................................................... 6-2

6.3.1 Replacing the Piezo Speaker.......................................... 6-3

6.3.2 Replacing the Monitor Speaker....................................... 6-4

6.3.3 Replacing the Hose Fitting.............................................. 6-5

6.3.4 Removing the UIF Board................................................. 6-5

6.3.5 Removing the Pump Module........................................... 6-7

6.4 Lithium Battery Replacement ....................................................... 6-8

6.5 Reassembly.................................................................................. 6-8

Section 7: Spare Parts

7.1 Introduction................................................................................... 7-1

Section 8: Packing for Shipment

8.1 General Instructions ..................................................................... 8-1

8.2 Repacking in Original Carton ....................................................... 8-2

8.3 Repacking in a Different Carton ................................................... 8-3

Section 9: Specifications

9.1 General......................................................................................... 9-1

9.2 Electrical....................................................................................... 9-1

9.3 Physical Characteristics ............................................................... 9-1

9.4 Environmental .............................................................................. 9-1

9.5 Alarms .......................................................................................... 9-2

9.6 Factory Defaults ........................................................................... 9-2

9.7 Performance................................................................................. 9-3

Appendix

...................................................................................................... A-1

A1 Integrity Test................................................................................. A-1

A2 Error Types................................................................................... A-2

A3 User-Correctable Error Codes...................................................... A-3

A4 Failure Error Codes...................................................................... A-4

A5 Internally Corrected Error Codes.................................................. A-4

........................................................................ 5-1

................................................................... 6-1

................................................................................ 7-1

............................................................... 8-1

............................................................................ 9-1

v

Table of Contents

LIST OF FIGURES

Technical Supplement

................................................................................ S-1

S1 Introduction................................................................................... S-1

S2 Overview ...................................................................................... S-1

S3 Stackbus Interconnect.................................................................. S-2

S4 Circuit Analysis............................................................................. S-3

S4.1 Functional Overview ....................................................... S-3

S4.2 Detailed Circuit Analysis ................................................. S-5

S4.2.1 UIF/Power Supply Module .............................................. S-5

S4.2.2 Blood Pressure Module................................................... S-9

S4.2.3 Display Board.................................................................. S-10

S5 Schematic Diagrams .................................................................... S-11

1-1 N-3100 Front Panel (North American) .............................................. 1-2

1-2 N-3100 Front Panel (International) ................................................... 1-2

3-1 Self-Test Display .............................................................................. 3-2

6-1 Fuse Replacement............................................................................ 6-2

6-2 N-3100 Corner Screws ..................................................................... 6-2

6-3 Separating the Monitor and Disconnecting the Cables .................... 6-3

6-4 Removing the Monitor Speaker Assembly........................................ 6-4

6-5 Removing UIF and Display PCBs..................................................... 6-6

6-6 Removing Pump Module................................................................... 6-7

6-7 Installing the Handle ......................................................................... 6-9

7-1 N-3100 Expanded View .................................................................... 7-2

8-1 Repacking the N-3100 ..................................................................... 8-2

S2-1 Oscillatory Blood Pressure Measurement ........................................ S-2

S4-1 N-3100 Functional Block Diagram................................................... S-4

S4-2 Internal/External Bus Connections ................................................... S-5

S4-3 Speaker Driver and Volume Control Block Diagram ........................ S-8

S4-4 Display Board Block Diagram........................................................... S-10

LIST OF TABLES

3-1 Earth Leakage Current Limits........................................................... 3-17

3-2 Patient Leakage Current Limits ........................................................ 3-18

3-3 Patient Leakage Current Test Configurations................................... 3-19

4-1 Configuration Mode Menu ................................................................ 4-2

4-2 Service Mode Menu.......................................................................... 4-9

5-1 Problem Categories.......................................................................... 5-2

5-2 Power Problems................................................................................ 5-3

5-3 N-3100 User-Correctable Error Codes ............................................ 5-4

5-4 N-3100 Failure Error Codes.............................................................. 5-5

5-5 Button Problems ............................................................................... 5-7

5-6 Display/Alarms Problems ................................................................. 5-7

5-7 Operational Performance Problems ................................................. 5-8

5-8 Stack Problems................................................................................. 5-8

A-1 Error Types....................................................................................... A-2

A-2 N-3100 Failure Error Codes.............................................................. A-4

A-3 N-3100 Internally Corrected Error Codes ........................................ A-5

S4-1 J1 Connector..................................................................................... S-8

S4-2 J5 Upper Inter-Stack Connector ....................................................... S-9

S4-3 J2 Speaker Connector...................................................................... S-9

vi

SECTION 1: INTRODUCTION

1.1 Manual Overview

1.2 Warnings, Cautions, and Notes

1.3 N-3100 Blood Pressure Monitor Description

1.4 Related Documents

1.1 MANUAL OVERVIEW

This manual contains information for servicing the NELLCOR SYMPHONY
N-3100 blood pressure monitor. Only qualified service personnel should
service this product. Before servicing the N-3100, read the operator’s manual
carefully for a thorough understanding of operation.

1.2 WARNINGS, CAUTIONS, AND NOTES

This manual uses three terms that are important for proper operation of the
monitor: Warning, Caution, and Note.

1.2.1 Warning

A warning precedes an action that may result in injury or death to the
patient or user. Warnings are boxed and highlighted in boldface type.

1.2.2 Caution

A caution precedes an action that may result in damage to, or malfunction of,
the monitor. Cautions are highlighted in boldface type.

1.2.3 Note

A note gives information that requires special attention.

1.3 N-3100 BLOOD PRESSURE MONITOR DESCRIPTION

The N-3100 is a noninvasive blood pressure monitor that measures systolic,
diastolic, and mean arterial blood pressure. It also derives the patient’s pulse
rate at the time of blood pressure measurement. The N-3100 is intended for
hospital use to monitor adult, pediatric, or neonatal patients. The N-3100 can
be used in mobile environments when stacked with the N-3000, the N-3200,
or both. When used in mobile environments, the N-3100 must be protected
from excessive moisture such as direct rainfall.

The N-3100 can operate as a standalone monitor or it can be connected to
(stacked with) other NELLCOR SYMPHONY instruments, such as the
N-3000 pulse oximeter, the N-3200 display/printer, or both.

The physical and operational characteristics of the monitor are described in
the operator’s manual and Section 9, Specifications, of this manual.

Figures 1-1 and 1-2 depict the North American and International front panels
of the N-3100 and the names of its displays and controls.

1-1

Section 1: Introduction

Note: All graphics presented in this manual relevant to the monitor are

depicted in the International symbol format. Refer to your operator’s
manual and Figures 1-1 and 1-2 of this manual for applicable
translations.

1 2

SYSTOLIC

mmHg

NEONATAL

20

DIASTOLIC

mmHg

3

PULSE

RATE

19

MEAN

mmHg

CYCLE

18

17

4

567

AUTO

MANUAL

LIMITS

START

STOP

16

9

8

PULSECYCLE

STAT

15

Figure 1-1: N-3100 Front Panel (North American)

MAN

9

8

1 2

SYS

mmHg

NEO

DIA

mmHg

3

MAP

mmHg

567

4

AUTO

10

PRINT

14

10

11

13

11

12

12

1 SYSTOLIC display 11 POWER ON indicator
2 DIASTOLIC display 12 BATTERY IN USE/BATTERY LOW indicator
3 MEAN/PULSE RATE display 13 PRINTER IN USE/STACKED indicator
4 UPPER ALARM LIMIT button 14 PRINT button
5 CYCLE button 15 STAT MODE button
6 AUTOMATIC MODE indicator 16 START/STOP MEASUREMENT button
7 MANUAL MODE indicator 17 LOWER ALARM LIMIT button
8 PULSE button 18 CYCLE indicator
9 AUDIBLE ALARM OFF indicator 19 PULSE RATE indicator
10 ON/STANDBY button 20 NEONATAL MODE indicator

1.4 RELATED DOCUMENTS

To perform test and troubleshooting procedures and to understand the
principles of operation and circuit analysis sections of this manual, you must
know how to operate the monitor. Refer to the N-3100 operator’s manual. To
understand the various Nellcor Puritan Bennett cuffs and hose that work
with the monitor, refer to the individual cuff and hose directions for use.

20

19

18

Figure 1-2: N-3100 Front Panel (International)

1314151617

1-2

SECTION 2: ROUTINE MAINTENANCE

2.1 Cleaning

2.2 Periodic Safety and Functional Checks

2.3 Batteries

2.1 CLEANING

Caution: Do not immerse the N-3100 or its accessories in liquid or use
caustic or abrasive cleaners. Do not spray or pour any liquid on the
monitor or its accessories.

To clean the N-3100, dampen a cloth with a commercial, nonabrasive cleaner
and wipe the instrument exterior surfaces lightly. Do not allow any liquids to
come in contact with the power connector, fuse holder, or switches. Do not
allow any liquids to penetrate connectors or openings in the instrument cover.
For cuffs and hoses, follow individual directions for use.

2.2 PERIODIC SAFETY AND FUNCTIONAL CHECKS

The following safety checks should be performed by a qualified service
technician after any repair or opening of the case, upon return of the
instrument from any use outside your institution’s control, or at least every 2
years.

1. Inspect the exterior of the N-3100 and verify that there is no evidence of
damage. Refer to Section 5, Troubleshooting for repair. If the N-3100
cannot be repaired, contact Nellcor Puritan Bennett’s Technical Services
Department or your local Nellcor Puritan Bennett representative.

2. 3 BATTERIES

2. Inspect safety labels for legibility. If labels are not legible, contact
Nellcor Puritan Bennett’s Technical Services Department or your local
Nellcor Puritan Bennett representative.

3. Verify that the monitor performs properly as described in paragraph 3.3.

4. Perform the electrical safety tests detailed in paragraph 3.4. If the unit
fails these electrical safety tests, do not attempt to repair, contact Nellcor
Puritan Bennett’s Technical Services Department or your local Nellcor
Puritan Bennett representative.

5. Inspect fuse(s) for proper rating (AC inlet fuse: 0.8 Amp, 250 Volt). If
necessary, replace as described in paragraph 6.2.

Nellcor Puritan Bennett recommends replacing all instrument batteries at
least every 2 years. To replace the batteries, refer to Section 6, Disassembly
Guide.

If the N-3100 has been stored for more than 30 days and has not been
connected to an SPS power supply, charge the battery before use. A fully
discharged battery requires a 14-hour charge for a full charge. A 6-hour
charge is required for 1 hour of operating time. Connect the N-3100 to an SPS
external power supply during storage to ensure that the battery remains fully
charged and the N-3100 is ready for immediate use.

2-1

SECTION 3: PERFORMANCE VERIFICATION

3.1 Introduction

3.2 Equipment Needed

3.3 Performance Tests

3.4 Safety Tests

3.1 INTRODUCTION

This section discusses the tests used to verify performance of the monitor. All
tests are accomplished through the control panel.

3.2 EQUIPMENT NEEDED
Equipment Description

AC Power Adapter SPS-I or SPS-I1 (International) or

SPS-N or SPS-N1 (North American)

Electrical Safety Analyzer Must meet current AAMI

specifications

Blood Pressure Simulator Bio-tek “BP Pump” Noninvasive

Blood Pressure Analyzer or
equivalent

3.3 PERFORMANCE TESTS

The following tests are used to verify performance of the N-3100 and should
be performed following troubleshooting and repairs. If the N-3100 fails any
test, refer to Section 5, Troubleshooting.

3.3.1 Power-up

The power-up tests (paragraphs 3.3.1.1 through 3.3.1.3) verify the following
monitor functions:

• Power-On Self-Test

• Power-On Defaults for Adult-Pediatric Alarm Limits and Ranges

• Power-On Defaults for Neonatal Alarm Limits and Ranges

3.3.1.1 Power-On Self-Test

1. Connect the monitor to model SPS-I (or SPS-I1) or model SPS-N (or

SPS-N1) external power supply or, if stacked with the N-3200, connect
AC power to the N-3200.

2. Do not connect any hoses or cuffs to the monitor.

3-1

Section 3: Performance Verification

3. Observe the monitor front panel. With the N-3100 in STANDBY (turned

off), press the ON/STANDBY button. In order to successfully complete
the self-test, the monitor must perform the following sequence.

a. The monitor emits three consecutively higher-pitched beeps.
b. All indicators light momentarily as illustrated in Figure 3-1. Verify

that “8.8.8.” is shown in the SYSTOLIC, DIASTOLIC, and
MEAN/PULSE RATE displays.

Note: Slight differences in the brightness of display segments and

indicators are normal and acceptable.

SYS

mmHg

NEO

DIA

mmHg

MAP

mmHg

AUTO

MAN

Figure 3-1: Self-Test Display

c. All displays (except the POWER ON indicator) turn off briefly.
d. Each segment in the digital displays lights individually in sequence

in a scanning, or firefly, test pattern and all indicators light
momentarily.

e. The sequence of steps b and c will be repeated until all internal tests

are complete.

Note: The number of times the sequence of steps b and c is

repeated is dependent on the amount of information stored
in trend memory. Typically, you will see two cycles of the
sequence.

f. A single, 1-second beep is produced and all displays again illuminate

momentarily, indicating the automatic Power-On Self-Test is
complete.

3-2

g. The POWER ON indicator and the MANUAL MODE indicator are

illuminated. A “–” is displayed in each window of the SYSTOLIC,
DIASTOLIC and MEAN/PULSE RATE displays. This is referred to
as the normal mode steady state.

SYS

mmHg

DIA

mmHg

MAP

mmHg

Section 3: Performance Verification

Caution: Pressing and holding the NEW PATIENT/NEONATAL
button (3 seconds or more) until three beeps sound clears all
previously stored patient data.

h. Press and hold the NEW PATIENT/NEONATAL button (located on

the rear panel) for approximately 3 seconds until you hear three
beeps to indicate that stored patient data is cleared.

3.3.1.2 Power-On Defaults for Adult-Pediatric Alarm Limits and Ranges

Note: The following procedure is written using Nellcor Puritan Bennett

factory-set power-on default settings. If your institution has other
custom power-on default settings, those values will be displayed and
should be substituted in the following procedure. The N-3100 can be
reset to factory power-on defaults using the service mode procedure
described in Paragraph 4.3.11, Menu Item 20, or configuration mode,
as described in Paragraph 4.2.13, Configuration Menu (item 3).

In the following procedures, each time the UPPER ALARM LIMIT
button or the LOWER ALARM LIMIT button is pressed, the N-3100
will emit a beep.

When observing or changing default limits, a 3-second timeout is in
effect, that is, if no action is taken within 3 seconds, the monitor
automatically returns to the normal operating mode steady state.

The following procedures use the N-3100 UP and DOWN ARROW
buttons located on the top of the monitor. When the N-3100 is
stacked with the N-3000, the N-3200, or both, the Nellcor knob on
either of these units can be used to perform the function of the
N-3100 UP and DOWN ARROW buttons. Turning the Nellcor knob in
a clockwise direction is equivalent to pressing the N-3100 UP
ARROW button. Turning the knob in a counterclockwise direction is
equivalent to pressing the N-3100 DOWN ARROW button. There will
be no sounds or beeps associated with turning a Nellcor knob. When
the N-3100 is stacked with the N-3000, the UP and DOWN ARROW
buttons are not accessible and the Nellcor knob must be used.

1. Press the ON/STANDBY button to turn the unit on. Verify that the

N-3100 is in adult-pediatric mode, which is indicated by the NEONATAL
MODE indicator being off. If the indicator is lit, quickly press and
release the NEW PATIENT/NEONATAL button twice to place the
N-3100 in the adult-pediatric mode. When the unit is in the normal mode
steady state, press and release the UPPER ALARM LIMIT button.
Verify that the monitor emits a single beep when you press the button.
Verify that the SYSTOLIC display indicates the default alarm limit
value of “240” for a few seconds and verify that the other displays show
dashes while the “240” is displayed as shown below. Do not press any
buttons for at least 3 seconds and all displays will change to show a dash
in the center of each character (normal mode steady state).

SYS

mmHg

DIA

mmHg

MAP

mmHg

3-3

Section 3: Performance Verification

2. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button. Press and hold the DOWN ARROW button until
a value of “70.” is shown in the SYSTOLIC display.

Note: A period (“.”) following a displayed alarm limit value is an

3. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Verify that the monitor emits a single beep when
you press the button. Within 3 seconds, verify the SYSTOLIC display
indicates an alarm limit value of “70” and verify that the other displays
show a dash at the bottom while the “70” is displayed as shown below.

indication that the alarm limit value has been changed from the
power-on default value previously set in the N-3100.

SYS

mmHg

DIA

mmHg

MAP

mmHg

4. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Within 3 seconds, press and hold the DOWN
ARROW button until “60.” is displayed in the SYSTOLIC display. Verify
“60.” is the lowest value to which the lower alarm limit can be adjusted.

5. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Within 3 seconds, press and hold the UP
ARROW button and verify that the upper alarm limit setting of “70.” is
the highest value to which the lower systolic alarm limit can be adjusted.

6. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button twice. Verify that the monitor emits a single beep
each time you press the button. Verify that the DIASTOLIC display
indicates default alarm limit value of “210” for a few seconds and verify
that the other displays show dashes at the top while the “210” is
displayed.

7. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button twice. Press and hold the DOWN ARROW button
until “50.” is shown in the DIASTOLIC display

8. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button twice. Verify that the monitor emits a single beep
each time you press the button. Within 3 seconds, verify that the
DIASTOLIC display indicates an alarm limit value of “50” and verify
that the other displays show dashes at the bottom while the “50” is
displayed.

3-4

9. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button twice. Within 3 seconds, press and hold the
DOWN ARROW button until “40.” is displayed in the DIASTOLIC
display. Verify that “40.” is the lowest value to which the lower alarm
limit can be adjusted.

10. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button twice. Within 3 seconds, press and hold the UP
ARROW button and verify that “50.” is the highest value to which the
lower alarm limit can be adjusted.

Section 3: Performance Verification

11. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button three times. Verify that the monitor emits a
single beep each time you press the button. Verify that the
MEAN/PULSE RATE display indicates an alarm limit value of “225” for
a few seconds and verify that the other displays show dashes at the top
while the “225” is displayed.

12. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button three times. Press and hold the DOWN ARROW
button until “55.” is displayed in the MEAN/PULSE RATE display.

13. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button three times. Verify that the monitor emits a
single beep each time you press the button. Within 3 seconds, verify that
the MEAN/PULSE RATE display indicates the default alarm limit value
of “55” and verify that the other displays show dashes at the bottom
while the “55” is displayed.

14. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button three times. Within 3 seconds, press and hold the
DOWN ARROW button until “55.” is shown in the MEAN/PULSE RATE
display. Verify that “55.” is the lowest value to which the lower alarm
limit can be adjusted.

15. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button three times. Within 3 seconds, press and hold the
UP ARROW button and verify that “55.” is the highest value to which
the lower alarm limit can be adjusted.

16. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button four times. Verify that the monitor emits a single
beep each time you press the button. Verify that the PULSE RATE
indicator is lit and the MEAN/PULSE RATE display indicates the
default alarm limit value of “170” for a few seconds and verify that the
other displays show a dash at the top of each display character while the
“170” is displayed.

17. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button four times. Press and hold the DOWN ARROW
button until “40.” is shown in the MEAN/PULSE RATE display.

18. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button four times. Verify that the monitor emits a single
beep each time you press the button. Within 3 seconds, verify that the
PULSE RATE indicator is lit and the MEAN/PULSE RATE display
indicates the default alarm limit value of “40” and verify that the other
displays show dashes at the bottom while the “40” is displayed.

19. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button four times. Within 3 seconds, press and hold the
DOWN ARROW button until “30.” is displayed in the MEAN/PULSE
RATE display. Verify that “30.” is the lowest value to which the lower
alarm limit can be adjusted.

20. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button four times. Within 3 seconds, press and hold the
UP ARROW button and verify that “40.” is the highest value to which
the lower alarm limit can be adjusted.

3-5

Section 3: Performance Verification

21. Press the ON/STANDBY button to turn the monitor off. Verify that the

monitor emits three consecutively lower-pitched beeps.

22. Press the ON/STANDBY button to turn the monitor on. The monitor

performs the Power-On Self-Test described in 3.3.1.1, steps 3a.
through 3g.

23. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button. Verify that the monitor emits a single beep and
the SYSTOLIC display indicates an alarm limit of “240” for a few
seconds.

24. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Verify that the monitor emits a single beep and
that the SYSTOLIC display indicates an alarm limit of “70” for a few
seconds.

25. From the normal mode steady state, press the UPPER ALARM LIMIT

button two times rapidly. Verify that the monitor emits two beeps and
that the DIASTOLIC display indicates an alarm limit of “210” for a few
seconds.

26. From the normal mode steady state, press the LOWER ALARM LIMIT

button two times rapidly. Verify that the monitor emits two beeps and
that the DIASTOLIC display indicates an alarm limit of “50” for a few
seconds.

27. From the normal mode steady state, press the UPPER ALARM LIMIT

button three times rapidly. Verify that the monitor emits three beeps
and that the MEAN/PULSE RATE display indicates an alarm limit of
“225” for a few seconds.

28. From the normal mode steady state, press the LOWER ALARM LIMIT

button three times rapidly. Verify that the monitor emits three beeps
and the MEAN/PULSE RATE display indicates an alarm limit of “55” for
a few seconds.

29. From the normal mode steady state, press the UPPER ALARM LIMIT

button four times rapidly. Verify that the monitor emits four beeps, the
PULSE RATE indicator lights and that the MEAN/PULSE RATE display
indicates an alarm limit of “170” for a few seconds.

30. From the normal mode steady state, press the LOWER ALARM LIMIT

button four times rapidly. Verify that the monitor emits four beeps, the
PULSE RATE indicator lights, and the MEAN/PULSE RATE display
indicates an alarm limit of “40” for a few seconds.

31. Press the ON/STANDBY button to place the N-3100 in the standby

mode. Verify that the monitor emits three consecutively higher-pitched
beeps.

3-6

3.3.1.3 Power-On Defaults for Neonatal Alarm Limits and Ranges

Note: The following procedure is written using Nellcor Puritan Bennett

factory-set power-on default settings. If your institution has other
custom power-on default settings, those values will be displayed and
should be substituted in the following procedure. The N-3100 can be
reset to factory power-on defaults using the service mode procedure
described in Paragraph 4.3.11, Menu Item 20, or configuration mode,
as described in Paragraph 4.2.13, Configuration Menu (item 3).

In the following procedures, each time the UPPER ALARM LIMIT
button or the LOWER ALARM LIMIT button is pressed, the N-3100
will emit a beep.

When observing or changing default limits, a 3-second timeout is in
effect, i.e., if no action is taken within 3 seconds, the monitor
automatically returns to the normal operating mode steady state.

The following procedures use the N-3100 UP and DOWN ARROW
buttons located on the top of the monitor. When the N-3100 is
stacked with the N-3000, the Nellcor knob on this unit can be used to
perform the function of the N-3100 UP and DOWN ARROW buttons.
Turning the Nellcor knob in a clockwise direction is equivalent to
pressing the N-3100 UP ARROW button. Turning the knob in a
counterclockwise direction is equivalent to pressing the N-3100
DOWN ARROW button. There will be no sounds or beeps associated
with turning the knob. When the N-3100 is stacked with the N-3000,
the UP and DOWN ARROW buttons are not accessible and the
Nellcor knob must be used.

Section 3: Performance Verification

1. Press the ON/STANDBY button to turn the unit on. Verify that the

N-3100 is in the neonatal mode, which is indicated by the NEONATAL
MODE indicator being lit. If the indicator is not lit, quickly press and
release the NEW PATIENT/NEONATAL button twice to place the
N-3100 in the neonatal mode. When the unit is in the normal mode
steady state, press and release the UPPER ALARM LIMIT button.
Verify that the monitor emits a single beep when you press the UPPER
ALARM LIMIT button. Verify that the SYSTOLIC display indicates an
alarm limit value of “120” for a few seconds and verify that the other
displays show dashes at the top while the “120” is displayed. Do not
press any buttons for at least 3 seconds and all displays will change to
show a dash in the center of each character (normal mode steady state).

2. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button. Press and hold the DOWN ARROW button until
“50.” is displayed the SYSTOLIC display.

Note: A period (“.”) following a displayed alarm limit value is an

indication that the alarm limit value has been changed from the
power-on default value previously set in the N-3100.

3. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Verify that the monitor emits a single beep when
you press the button. Within 3 seconds, verify that the SYSTOLIC
display indicates an alarm limit value of “50” (the default systolic lower
alarm limit) and verify that the other displays show dashes at the bottom
while the “50” is displayed.

3-7

Section 3: Performance Verification

4. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Within 3 seconds, press and hold the DOWN
ARROW button until “40.” is displayed in the SYSTOLIC display. Verify
that “40.” is the lowest value to which the lower alarm limit can be
adjusted.

5. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Within 3 seconds, press and hold the UP
ARROW button and verify that “50.” is the highest value to which the
lower alarm limit can be adjusted.

6. From the normal mode steady state, press the UPPER ALARM LIMIT

button twice. Verify that the monitor emits a single beep each time you
press the button. Verify that the DIASTOLIC display indicates a default
alarm limit value of “80” for a few seconds and verify that the other
displays show dashes at the top while the “80” is displayed.

7. From the normal mode steady state, press the UPPER ALARM LIMIT

button twice. Press and hold the DOWN ARROW button until “30.” is
shown in the DIASTOLIC display.

8. From the normal mode steady state, press the LOWER ALARM LIMIT

button twice. Verify that the monitor emits a single beep each time you
press the button. Within 3 seconds, verify that the DIASTOLIC display
indicates a default alarm limit value of “30” (the default diastolic lower
alarm limit) and verify that the other displays show dashes at the bottom
while the “30” is displayed.

9. From the normal mode steady state, press the LOWER ALARM LIMIT

button twice. Within 3 seconds, press and hold the DOWN ARROW
button until “20.” is displayed in the DIASTOLIC display. Verify that
“20.” is the lowest value to which the lower alarm limit can be adjusted.

10. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button twice. Within 3 seconds, press and hold the UP
ARROW button and verify that “30.” is the highest value to which the
lower alarm limit can be adjusted.

11. From the normal mode steady state, press the UPPER ALARM LIMIT

button three times. Verify that the monitor emits a single beep each time
you press the button. Verify that the MEAN/PULSE RATE display
indicates an alarm limit value of “95” (the default mean upper alarm
limit) for a few seconds, and verify that the other displays show dashes
at the top while the “95” is displayed.

12. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button three times. Press and hold the DOWN ARROW
button until “45.” is shown in the MEAN/PULSE RATE display.

13. From the normal mode steady state, press the LOWER ALARM LIMIT

button three times. Verify that the monitor emits a single beep each time
you press the button. Within 3 seconds, verify that the MEAN/PULSE
RATE display indicates an alarm limit value of “45” and verify that the
other displays show a dash at the bottom of each display character while
the “45” is displayed.

3-8

Section 3: Performance Verification

14. From the normal mode steady state, press the LOWER ALARM LIMIT

button three times. Within 3 seconds, press and hold the DOWN
ARROW button until “35.” is displayed in the MEAN/PULSE RATE
display. Verify that “35.” is the lowest value to which the lower alarm
limit can be adjusted.

15. From the normal mode steady state, press the LOWER ALARM LIMIT

button three times. Within 3 seconds, press and hold the UP ARROW
button and verify that “45.” is the highest value to which the lower alarm
limit can be adjusted.

16. From the normal mode steady state, press the UPPER ALARM LIMIT

button four times. Verify that the monitor emits a single beep each time
you press the button. Verify that the PULSE RATE indicator is lit and
the MEAN/PULSE RATE display indicates an alarm limit value of “230”
(the default pulse rate upper alarm limit) for a few seconds and verify
that the other displays show dashes at the top while the “230” is
displayed.

17. From the normal mode steady state, press the UPPER ALARM LIMIT

button four times. Press and hold the DOWN ARROW button until “40.”
is shown in the MEAN/PULSE RATE display.

18. From the normal mode steady state, press the LOWER ALARM LIMIT

button four times. Verify that the monitor emits a single beep each time
you press the button. Within 3 seconds, verify that the PULSE RATE
indicator is lit and the MEAN/PULSE RATE display indicates an alarm
limit value of “40” and verify that the other displays show dashes at the
bottom while the “40” is displayed.

19. From the normal mode steady state, press the LOWER ALARM LIMIT

button four times. Within 3 seconds, press and hold the DOWN ARROW
button until “30.” is displayed in the MEAN/PULSE RATE display.
Verify that “45.” is the lowest value to which the lower alarm limit can be
adjusted.

20. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button four times. Within 3 seconds, press and hold the
UP ARROW button and verify “40.” is the highest value to which the
lower alarm limit can be adjusted.

21. Press the ON/STANDBY button to turn the monitor off. Verify that the

monitor emits three consecutively lower-pitched beeps.

22. Press the N-3100 ON/STANDBY button to turn the monitor on. The

monitor performs the Power-On Self-Test described in 3.3.1.1, steps 3a.
through 3g.

23. From the normal mode steady state, press and release the UPPER

ALARM LIMIT button. Verify that the monitor emits a single beep and
that the SYSTOLIC display indicates an alarm limit of “120” for a few
seconds.

24. From the normal mode steady state, press and release the LOWER

ALARM LIMIT button. Verify that the monitor emits a single beep and
that the SYSTOLIC display indicates an alarm limit of “50” for a few
seconds.

3-9

Section 3: Performance Verification

25. From the normal mode steady state, rapidly press the UPPER ALARM

LIMIT button twice. Verify that the monitor emits two beeps and that
the DIASTOLIC display indicates an alarm limit of “80” for a few
seconds.

26. From the normal mode steady state, rapidly press the LOWER ALARM

LIMIT button twice. Verify that the monitor emits two beeps and that
the DIASTOLIC display indicates an alarm limit of “30” for a few
seconds.

27. From the normal mode steady state, rapidly press the UPPER ALARM

LIMIT button three times. Verify that the monitor emits three beeps and
that the MEAN/PULSE RATE display indicates an alarm limit of “95”
for a few seconds.

28. From the normal mode steady state, rapidly press the LOWER ALARM

LIMIT button three times. Verify that the monitor emits three beeps and
that the MEAN/PULSE RATE display indicates an alarm limit of “45”
for a few seconds.

29. From the normal mode steady state, rapidly press the UPPER ALARM

LIMIT button four times. Verify that the monitor emits four beeps, the
PULSE RATE indicator lights and that the MEAN/PULSE RATE display
indicates an alarm limit of “230” for a few seconds.

30. From the normal mode steady state, rapidly press the LOWER ALARM

LIMIT button four times. Verify that the monitor emits four beeps, the
PULSE RATE indicator lights, and the MEAN/PULSE RATE display
indicates an alarm limit of “40” for a few seconds.

31. Press the ON/STANDBY button to place the N-3100 in the standby

mode. Verify that the monitor emits three consecutively higher-pitched
beeps.

3.3.2 Verification of Pneumatic System

Tests in paragraphs 3.3.2.1 through 3.3.2.7 verify the functionality of the
N-3100 pneumatic system. These tests were designed to use the Bio-Tek “BP
Pump” noninvasive blood pressure (NIBP) simulator. The internal test
volume of the Bio-Tek simulator is 250 cm3, which is used to calculate the
inflation/deflation rate periods. The Bio-Tek simulator or an equivalent NIBP
simulator is required to perform these tests.

The N-3100 should be placed in the service mode for each of these tests. For a
detailed explanation of the service mode, refer to Section 4, Configuration
and Service Modes.

Note: The N-3100 cannot be placed in the service mode while it is stacked

with the N-3000. Disconnect the N-3000 from the N-3100 before
performing the verification tests.

Perform all of the following tests to verify the pneumatic system functionality:

3-10

• Paragraph 3.3.2.1 Pressure Transducer Accuracy

• Paragraph 3.3.2.2 Pneumatic Leakage - Adult

• Paragraph 3.3.2.3 Pneumatic Leakage - Neonate

• Paragraph 3.3.2.4 Cuff Inflation Rate

• Paragraph 3.3.2.5 Cuff Deflation Rate

• Paragraph 3.3.2.6 High Pressure - Adult

• Paragraph 3.3.2.7 High Pressure - Neonate

Section 3: Performance Verification

These tests can be performed individually (in any order) or sequentially.
However, all of the tests must be performed to verify the pneumatic system
functionality. Prior to performing any of these tests, perform the following
setup procedure. If these tests are performed in sequence, this procedure
needs to be performed once prior to the first test.

1. Turn on the Bio-Tek simulator and press the MODE button three times

to place the simulator in the tests mode. The simulator screen will
indicate “Internal Cuff” and “Pressure Gauge.”

2. Connect the simulator hose to the hose connector on the right side panel

of the N-3100.

3. With the N-3100 in the standby mode (off) and connected to AC power,

while simultaneously pressing and holding the UPPER ALARM LIMIT
button, the LOWER ALARM LIMIT button, and the PRINT button,
press and release the ON/STANDBY button. Continue to hold down the
UPPER ALARM LIMIT, LOWER ALARM LIMIT and PRINT buttons
until the Power-On Self-Test is complete. “SEr” will flash in the
MEAN/PULSE RATE display.

4. Within 15 seconds, press and release the PRINT button to place the

N-3100 in the service mode steady state. “SEr” is continuously displayed
in the MEAN/PULSE RATE display.

Note: To exit any test and return to the service mode steady state,

press the LOWER ALARM LIMIT button.
To exit the service mode steady state at any time, press the

ON/STANDBY button to turn the N-3100 off.
If there is no button activity for 5 minutes, the N-3100 will shut

itself off and exit the service mode.

3.3.2.1 Pressure Transducer Accuracy

Perform the following test to verify the pressure accuracy of the N-3100
pressure transducer. Prior to performing this procedure, the setup procedure
in paragraph 3.3.2, “Verification of Pneumatic System” must be completed.

1. Press the UP/DOWN ARROW buttons until menu item 30 is displayed in

the SYSTOLIC display.

2. Press the UPPER ALARM LIMIT button.

3. Press the START/STOP button. The simulator begins to pressurize. The

current pressure in mmHg is displayed in the DIASTOLIC display.

4. Allow 30 seconds for the pressure to stabilize.

5. The numbers displayed by the simulator and in the DIASTOLIC display

should be within 4 mmHg of each other to successfully complete the test.

6. Manually stop the test with the START/STOP button.

Note: If the test is not stopped manually within 10 minutes, the

N-3100 will automatically stop the test.

7. Return to the service mode steady state by pressing the LOWER ALARM

LIMIT button.

3-11

Section 3: Performance Verification

3.3.2.2 Pneumatic Leakage—Adult

The pneumatic leakage test verifies the integrity of the pneumatic system in
the adult mode. Prior to performing this procedure, the setup procedure in
paragraph 3.3.2 must be completed.

1. Press the UP/DOWN ARROW buttons until menu item 33 is displayed in

the SYSTOLIC display.

2. Press the UPPER ALARM LIMIT button.

3. Press the START/STOP button. The simulator begins to pressurize. The

current pressure reading will be displayed in the DIASTOLIC display
until the test is completed.

4. Approximately 4 to 5 minutes later, the simulator will depressurize. The

SYSTOLIC display indicates menu item “33.0.” The DIASTOLIC display
indicates the change in pressure in mmHg from the reference pressure
reading until the end of the 4 to 5 minute period.

5. A reading of 6 mmHg or less indicates successful completion of the test.

6. Return to the service mode steady state by pressing the LOWER ALARM

LIMIT button.

3.3.2.3 Pneumatic Leakage—Neonate

The pneumatic leakage test verifies the integrity of the pneumatic system in
the neonate mode. Prior to performing this procedure, the setup procedure in
paragraph 3.3.2 must be completed.

1. Press the UP/DOWN ARROW buttons until menu item 34 is displayed in

the SYSTOLIC display.

2. Press the UPPER ALARM LIMIT button.

3. Press the START/STOP button. The simulator begins to pressurize. The

current pressure reading will be displayed until the test is completed.

4. Approximately 4 to 5 minutes later, the simulator will depressurize. The

SYSTOLIC display indicates menu item “34.0.” The DIASTOLIC display
indicates the change in pressure in mmHg from the reference pressure
reading until the end of the 4 to 5 minute period.

5. A reading of 6 mmHg or less indicates successful completion of the test.

6. Return to the service mode steady state by pressing the LOWER ALARM

LIMIT button.

3-12

3.3.2.4 Cuff Inflation Rate

The cuff inflation rate test verifies the inflation rate of the N-3100. Prior to
performing this procedure, the setup procedure in paragraph 3.3.2 must be
completed.

1. Press the UP/DOWN ARROW buttons until menu item “31” is displayed

2. Press and release the UPPER ALARM LIMIT button.

3. Press and release the START/STOP button. The simulator begins to

4. At the end of the test cycle, the simulator depressurizes and the

5. Press the UP ARROW button to display menu item “31.1” in the

Section 3: Performance Verification

in the SYSTOLIC display.

pressurize. The current pressure in mmHg is displayed in the
DIASTOLIC display.

SYSTOLIC display indicates submenu item number “31.0.” The
DIASTOLIC display indicates the time in seconds, to the nearest tenth,
required to pressurize to 250 mmHg. A reading of 3.0–9.0 seconds
indicates successful completion of the test.

SYSTOLIC display. The DIASTOLIC display indicates the time in
seconds, to the nearest tenth, required to pressurize to 300 mmHg. A
reading of 4.0–9.0 seconds indicates successful completion of the test.

6. Return to the service mode steady state by pressing the LOWER ALARM

3.3.2.5 Cuff Deflation Rate

The cuff deflation rate test verifies the deflation rate. Prior to performing this
procedure, the setup procedure in paragraph 3.3.2 must be completed.

1. Press the UP/DOWN ARROW buttons until menu item “32” is displayed

2. Press the UPPER ALARM LIMIT button.

3. Press the START/STOP button. The simulator begins to pressurize. The

4. At the end of the test cycle, the simulator depressurizes and the

5. Press the UP ARROW button to display menu item 32.1 in the

LIMIT button.

in the SYSTOLIC display.

current pressure in mmHg is displayed in the DIASTOLIC display.

SYSTOLIC display indicates submenu item number “32.0.” The
DIASTOLIC display indicates the rate in mmHg per second, to the
nearest tenth, required to depressurize from 260 to 180 mmHg. A
reading of 4.6–6.2 seconds indicates successful completion of the test.

SYSTOLIC display. The DIASTOLIC display indicates the rate in mmHg
per second, to the nearest tenth, required to depressurize from 180 to
100 mmHg. A reading of 4.6–6.2 seconds indicates successful completion
of the test.

6. Press the UP ARROW button to display menu item 32.2 in the

SYSTOLIC display. The DIASTOLIC display indicates the rate in mmHg
per second, to the nearest tenth, required to depressurize from 100 to
60 mmHg. A reading of 3.3–5.2 seconds indicates successful completion
of the test.

3-13

Section 3: Performance Verification

7. Press the UP ARROW button to display menu item 32.3 in the

SYSTOLIC display. The DIASTOLIC display indicates the rate in mmHg
per second, to the nearest tenth, required to depressurize from 60 to
30 mmHg. A reading of 2.6–4.4 seconds indicates successful completion
of the test.

8. Return to the service mode steady state by pressing the LOWER ALARM

LIMIT button.

3.3.2.6 High Pressure—Adult

The high-pressure test verifies the functionality of the high-pressure relief
valve in the adult mode. Prior to performing this procedure, the setup
procedure in paragraph 3.3.2 must be completed.

1. Press the SELECT button on the Bio-Tek simulator until Over Pressure

Test is displayed.

2. From the N-3100 service mode steady state, press the UP/DOWN

ARROW button until menu item 35 is displayed in the SYSTOLIC
display.

3. Press and release the UPPER ALARM LIMIT button.

4. Press and release the START/STOP button. As soon as the N-3100 pump

begins to operate, press the START TEST button on the simulator. The
current pressure in mmHg is displayed in the DIASTOLIC display. The
simulator begins to pressurize until the high-pressure relief valve opens.
If the pressure relief valve does not open by the time 331 mmHg is
reached, the test is unsuccessful.

5. The SYSTOLIC display indicates menu item 35. The DIASTOLIC

display indicates the maximum pressure achieved. If the high-pressure
relief valve does not open, the DIASTOLIC display flashes. A reading of
330 mmHg or less indicates successful completion of the test.

6. Return to the service mode steady state by pressing the LOWER ALARM

LIMIT button.

3.3.2.7 High-Pressure—Neonate

The high-pressure test verifies the functionality of the high-pressure relief
valve in the neonate mode. Prior to performing this procedure, the setup
procedure in paragraph 3.3.2 must be completed.

1. Press the SELECT button on the Bio-Tek simulator until Over Pressure

Test is displayed.

2. From the service mode steady state, press the UP/DOWN ARROW

buttons until menu item 36 is displayed in the SYSTOLIC display.

3. Press and release the UPPER ALARM LIMIT button.

4. Press and release the START/STOP button. As soon as the N-3100 pump

begins to operate, press the START TEST button on the simulator. The
current pressure in mmHg is displayed in the DIASTOLIC display. The
simulator begins to pressurize until the high-pressure relief valve opens.
If the pressure relief valve does not open by the time 166 mmHg is
reached, the test is unsuccessful.

3-14

5. The test is complete when the pressure has increased, deflated, and the

MANUAL indicator turns off.

6. The SYSTOLIC display indicates menu item 36. A nonflashing

DIASTOLIC display indicates the maximum pressure achieved. If the
high-pressure relief valve does not open, the DIASTOLIC display flashes.
A reading of 165 mmHg or less indicates successful completion of the
test.

7. Return to the service mode steady state by pressing the LOWER ALARM

LIMIT button.

3.3.3 Pulse Rate Accuracy Tests

The following tests verify the functionality of pulse rate detection. A Bio-Tek
“BP Pump” Noninvasive Blood Pressure Simulator or equivalent is required.
The N-3100 will be used in the manual mode.

3.3.3.1 Pulse Rate Accuracy Test—Adult

This test verifies the accuracy of the blood pressure and pulse rate detection
in the adult mode.

1. Turn on the Bio-Tek simulator and press the MODE button three times

to place it in the Tests mode. The simulator screen will indicate “Internal
Cuff” and “Pressure Gauge.”

Section 3: Performance Verification

2. Connect the simulator hose to the hose connector on the right side panel

of the N-3100.

3. Place the simulator in the Adult Internal Cuff mode and return to Tests

mode.

4. Press the MODE button on the simulator until Simulation mode is

displayed.

5. Using the SELECT and ARROW buttons on the simulator, set the

systolic/diastolic values to 180/120, with a heart rate value of 100.

6. Turn the N-3100 on and ensure it is in the manual mode (the MANUAL

indicator is lit).

7. Set the N-3100 to the adult-pediatric mode (the NEONATAL MODE

indicator is not lit).

8. Press and release the START/STOP button on the N-3100.

9. After completion of the blood pressure test cycle, press the PULSE

button on the N-3100. The measured pulse rate appears in the
MEAN/PULSE RATE display.

10. A reading between 95–105 bpm indicates successful completion of the

test.

3-15

Section 3: Performance Verification

3.3.3.2 Pulse Rate Accuracy Test—Neonate

This test verifies the functionality of the pulse rate detection in the neonate
mode.

1. Turn on the Bio-Tek simulator and press the MODE button three times

to place it in the Tests mode. The simulator screen will indicate “Internal
Cuff” and “Pressure Gauge.”

2. Connect the simulator hose to the hose connector on the right side panel

of the N-3100.

3. Place the simulator in the Neonate Internal Cuff mode and return to

Tests mode.

4. Press the MODE button on the simulator until Simulation mode is

displayed.

5. Using the SELECT and ARROW buttons on the simulator, set the

systolic/diastolic values to 70/40, with a heart rate value of 140 and a
pulse volume of 35%.

6. Turn the N-3100 on and ensure that it is in the manual mode (the

MANUAL indicator is lit).

3.4 SAFETY TESTS

3.4.1 Ground Integrity

7. Set the N-3100 to the neonatal mode (the NEONATAL MODE indicator

is lit).

8. Press and release the START/STOP button on the N-3100.

9. After completion of the blood pressure test cycle, press the PULSE

button on the N-3100. The measured pulse rate appears in the
MEAN/PULSE RATE display.

10. A reading between 135–145 bpm indicates successful completion of the

test.

WARNING: To ensure the safety of the operator and patient when
the N-3100 is stacked with and powered by an N-3200, also perform
the safety tests in the N-3200 service manual. Failure to comply could
result in serious injury or death.

N-3100 safety tests consist of:

• Ground Integrity

• Electrical Leakage

This test verifies the integrity of the power cord ground wire from the AC
plug and the connection with the SPS external power supply chassis ground.

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1. Set up the electrical safety analyzer as follows:

Function: Ground Resistance Test
Range: mΩ (milliohms)

2. Connect the monitor’s AC plug to the analyzer as recommended in the

analyzer operating instructions.

3. Connect the analyzer resistance input lead to the equipotential terminal

(grounding stud) on the external power supply. Verify that the analyzer
indicates 150 milliohms or less.

3.4.2 Electrical Leakage

The following tests verify the electrical leakage of the monitor:

• Earth Leakage Current

• Patient Leakage Current

• Patient Source Current (Mains on Applied Part)

3.4.2.1 Earth Leakage Current

This test is in compliance with IEC 601-1 and AAMI Standard ES1,
paragraph 3.3.1, Chassis Source Current, between the power ground and
(Part B) exposed conductive hardware.

1. Configure the electrical safety analyzer as follows:

Section 3: Performance Verification

Function: Leakage
Range: µA

2. Connect the monitor AC plug to the electrical safety analyzer as

recommended by the analyzer operating instructions.

3. Connect the electrical safety analyzer "leakage" input lead to the

monitor's equipotential terminal.

4. The equipotential terminal is not connected to ground.

5. All functional earth terminals are not connected to ground.

Table 3-1: Earth Leakage Current Limits

AC LINE
POLARITY

NEUTRAL
LINE

POWER LINE
EARTH

LEAKAGE
CURRENT

Normal Closed Closed 100 µA
Normal Closed Open 300 µA

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Section 3: Performance Verification

3.4.2.2 Patient Leakage Current

This test is in compliance with AAMI Standard ES1, paragraph 3.3.2 and
IEC 601-1. Patient Leakage Current is measured between any individual
patient connection and power (earth) ground.

1. Configure the electrical safety analyzer as follows:

Function: Patient Leakage
Range: µA

2. Connect the monitor AC plug to the electrical safety analyzer as

recommended by the analyzer operating instructions for Patient Leakage
Current.

3. Connect the electrical safety analyzer patient leakage input lead to the

monitor's patient connector.

4. The equipotential terminal is not connected to ground.

5. All functional earth terminals are not connected to ground.

6. The leakage current must not exceed the values shown in the table

below:

Table 3-2: Patient Leakage Current Limits

AC LINE

POLARITY

NEUTRAL

LINE

POWER LINE

GROUND

CABLE

Normal Closed Closed 10 µA
Normal Open Closed 10 µA

Normal Closed Open 10 µA
Reverse Closed Closed 10 µA
Reverse Open Closed 10 µA
Reverse Closed Open 10 µA

3.4.2.3 Patient Leakage Current (Mains Voltage on the Applied Part)

This test is in compliance with AAMI Standard ES1, paragraph 4.4 and IEC
601-1. Patient Leakage Current is the measured value in a patient
connection if a source of 240 Volts, 50 Hz with respect to power (earth)
ground, is connected to that patient connection.

Warning: AC mains voltage will be present on the patient applied
part terminals during this test. Exercise caution to avoid electrical
shock hazard.

LEAKAGE
CURRENT

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1. Configure the electrical safety analyzer as follows:
Function: Patient Leakage (MOAP)

Range: µA

Section 3: Performance Verification

2. Connect the monitor AC plug to the electrical safety analyzer as

recommended by the operating instructions for patient sink (leakage)
current.

3. Connect the electrical safety analyzer patient leakage input lead to the

patient connector on the monitor's sensor input.

4. The equipotential terminal is not connected to ground.

5. All functional earth terminals are not connected to ground.

6. The analyzer leakage current must not exceed 10 µA for any of the

conditions shown below.

Table 3-3: Patient Leakage Current Test Configurations —

Mains Voltage on the Applied Part

AC LINE
POLARITY

NEUTRAL LINE POWER LINE

GROUND CABLE

Normal Closed Closed
Reverse Closed Closed

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