Model 7300 NICO2 Non Invasive Cardiac Output Monitor Users Manual

Thank you … Thank you for purchasing the NICO® Non-Invasive Cardiac Output monitor from Novametrix. NICO® measures cardiac output through respiratory gas analysis based on the well accepted Fick Principle, providing continuous and accurate display of cardiac output. The monitor also operates in Respiratory Mechanics-only mode, providing the clinician with a respiratory profile of the patient through a combination of capnography, airway flow and pressure, and pulse oximetry. We expect that you will find the application and use of NICO® extremely simple, making it easy to adopt this exciting technology into your clinical practice. NICO® can provide accurate cardiac output values without the need for invasive procedures, benefitting the patient, the clinician, and the health care system in general. We appreciate your patronage and look forward to developing a long-term relationship with you and your institution. Sincerely,

USA TOLL FREE 1-800-243-3444 PHONE 205-265-7701 FAX 205-284-0753 WORLD WIDE WEB: http://www.novametrix.com E-MAIL: Customer Service [email protected] Technical Service [email protected]

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Introduction About this manual

This manual is written for clinical personnel using the Novametrix NICO® Non-Invasive Cardiac Output Monitor, Model 7300, and the sensors and accessories intended for use with the monitor. This document contains information which is proprietary and the property of Novametrix Medical Systems Inc., and may not be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means, without the prior explicit written permission of Novametrix Medical Systems Inc. Novametrix reserves the right to change specifications without notice.

NICO® Monitor Technical Description

Per requirements of IEC 601-1, the NICO® monitor is classified as class II equipment, internally powered, with type BF applied part, and an enclosure protection rating of IPX0. The NICO® monitor is Year 2000 compliant. Transport/Storage: -10 to +55° C (14-131° F), 10-95% R.H. non-condensing Operating Conditions: 10 to +40° C (50 to 104° F), 10-90% R.H. non-condensing The NICO® monitor, Model 7300, contains no user serviceable parts. Refer servicing to qualified service personnel. A technical Service Manual is available for use by technical personnel.

Manufacturing Quality & Safety

The Novametrix Medical Systems Inc. manufacturing facility is certified to both ISO 9001 and EN46001 (MDD93/42/EEC Annex II). Novametrix’ products bear the “CE 0086” mark. The product is certified by Underwriter’s Laboratories (UL) to bear the UL mark; and tested by TÜV Rheinland to IEC 601-1/EN60601-1.

Declaration of Conformity with European Union Directive

The Authorized Representative for Novametrix equipment is:

Trademarks and Patents

CAPNOSTAT CO2 Sensor and NICO are registered trademarks (®); NICO2 and the stylized NICO2 with CO 2 shadow, NICO Sensor, NICO Loop and CObar (cardiac output confidence bar), SuperBright and Y-Sensor are trademarks (™) of Novametrix Medical Systems Inc. Other trademarks and registered trademarks are the property of their respective owners.

D.R.M. Green European Compliance Services Limited, Oakdene House, Oak Road, Watchfield Swindon, Wilts SN6 8TD United Kingdom

NICO ® and its sensors and accessories are covered by the following USA patents: 4,859,858, 4,859,859, 4,914,720, 5,146,092, 5,153,436, 5,190,058, 5,206,511, 5,251,121, 5,347,843, 5,369,277, 5,379,650, 5,398,680, 5,535,633, 5,616,923, 5,693,944, 5,789,660, 5,793,044, 5,820,550, 5,891,026, 5,999,834, 6,098,622, 6,126,610, D424,193, 6,179,784. Other patents pending.

Manual Revision History

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11-Mar-99 Release at Rev. 00. 23-Mar-99 Revision 01. 05-Oct-99 Revision 02. R-N677 20-Mar-00 Revision 03. R-N741 19-Oct-00 Revision 04, R-N807 01-Feb-01 Revision 05, R-N850

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Table of Contents Welcome to NICO®... 1 General Description... 1 Front Panel... 1 Rear Panel... 2 Symbols... 3 AC/Battery Operation... 4 NICO® Parameter List... 5 Principles of Operation... 8

Navigating in Cardiac Output mode... 10 Areas of the Display... 10 Navigating the Display System... 10 KNOB selectable Monitoring Screens... 11 MENU key Screen Displays... 13 DATA ENTRY key Screen Displays... 14

Navigating in Respiratory Mechanics mode... 16 Areas of the Display... 16 Navigating the Display System... 16 KNOB selectable Monitoring Screens... 17 MENU key Screen Displays... 18 DATA ENTRY key Screen Displays... 19

Safety... 21 Monitoring Cardiac Output... 24 Preparing for Use... 24 Begin NICO® monitoring... 25 Entering Patient Data... 28 Entering ABG Data... 29 C.O. Averaging... 31

Respiratory Monitoring... 32 Preparing for Use... 32 Begin Respiratory Monitoring... 34 Entering Patient Data... 34 Entering ABG Data... 36

Monitoring and Setup Screens... 39 Cardiac Output mode... 39 Respiratory Screens (Optional)... 41 Respiratory Mechanics mode... 46

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Notes on Patient Monitoring... 53 Automatic Purging... 53 Manual Purging... 53 Intra-Aortic Balloon Pump... 54 Configuration Menu... 55 Reference Handbooks... 55

Alerts... 56 NICO® Alert Priorities... 56 Responding to Alert Audio... 56 Parameter Limit Alerts... 57 No Respiration Alert... 58

NICO Sensor™... 59 Disposable NICO Sensors™... 59

CO2/Flow Sensors... 62 Choosing a CO2/Flow Sensor... 63 Connecting a CO2/Flow Sensor... 63

CAPNOSTAT® CO2 Sensor... 65 The CAPNOSTAT® CO2 Sensor... 65 CAPNOSTAT® Adapter Zero... 66

Pulse Oximetry Sensors... 67 Oximetry Sensors... 67 Finger Sensor... 68 Y-Sensor™... 68 Single Patient Use Sensors... 71

Messages... 73 Message Areas - Cardiac Output mode... 73 Message Areas - Respiratory Mechanics mode... 78

External Devices... 82 GE Medical Systems Solar® Interface... 82 Agilent Technologies VueLink Interface... 83 ASCII Output... 85 Analog Output... 86 Alerts and Messages... 87

Maintenance... 88 Cleaning and Sterilization... 88 Monitor Maintenance Schedules... 89 Battery Maintenance... 89

Specifications... 90 NICO® Accessories... 92 Warranty... 94

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General Description

Welcome to NICO® General Description NICO ®, a Non-Invasive Cardiac Output monitor from Novametrix Medical Systems Inc., noninvasively measures and displays cardiac output (C.O.). The NICO® monitor, Model 7300, also displays cardiac index and stroke volume, as well as various respiratory monitoring parameters including CO 2 elimination (VCO2) and alveolar minute ventilation. In Respiratory Mechanics mode, NICO® can be used as a respiratory profile monitor, without cardiac output displayed. In either mode, NICO® provides the clinician with important information to aid in precise and efficient patient management.

Indications

The NICO ® monitor is indicated for use by technically skilled clinical personnel. In Cardiac Output mode, the monitor is used for the monitoring of cardiac output and various respiratory parameters of adult patients receiving mechanical ventilation. In Respiratory Mechanics mode, the NICO® monitor is used for monitoring the respiratory parameters of adult, pediatric and neonatal patients. NICO® is not intended for any other purpose.

Contraindications

In Cardiac Output mode, use of the NICO® monitor is contraindicated in patients in whom a small rise (3-5 mmHg, 0.4-0.67 kPa) in their PaCO2 level cannot be tolerated.

Front Panel The NICO ® monitor’s front panel includes a display screen, sensor input connectors, a control knob, and operational push button keys and indicators that are explained below.

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Rear Panel

1

Display Screen. The screen displays NICO® data, respiratory mechanics, trends, waveforms and messages, along with setup and configuration data.

2

CAPNOSTAT® CO2 Sensor Input Connector. Connect only a Novametrix CAPNOSTAT® CO2 Sensor, Catalog Number 9567-00 here.

3

Connector Isolation Icon. Identifies the connector to either side of this icon as a type BF patient isolation connection.

4

Pulse Oximetry Sensor Input Connector. Connect only Novametrix pulse oximetry sensors and extension cables approved for use with the NICO® monitor.

5

NICO Sensor™ Input Connector. Connect only Novametrix NICO Sensors™, Catalog Number 8950-00, 8951-00 and 8952-00 or Novametrix CO2/Flow sensors, Catalog Number 9765-00, 9766-00 and 9767-00.

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KNOB. The KNOB is used to select monitoring screens, scroll through menus and to change or enter values. The KNOB is generally turned to access different monitoring screens and to highlight menu options, and pressed to accept or change those selections.

7

DATA ENTRY key. Press to activate the DATA ENTRY screen and illuminate the key’s green icon. Press the key again to return to the previously displayed screen. From the DATA ENTRY screen, you can enter patient information including height, weight and respiratory gas mixture, and access the ABG DATA ENTRY screen.

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MENU key. Press to activate the SELECT A SCREEN menu and illuminate the key’s green icon. Press the key again to return to the previously displayed screen. From the SELECT A SCREEN menu you can, by turning the knob, highlight the screen you wish to display. Press the MENU key or the KNOB to display that selected screen.

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SILENCE key. The SILENCE key is used to mute/prevent audible alerts. It also visually indicates the presence of a “High Priority Alert”. The Silence feature operates in two modes; a temporary “2 Minute Silence” mode and an “Audio Disabled” mode. • 2 Minute Silence - Press and release to activate or deactivate the two minute silence. The key’s icon illuminates amber when active and audible alerts will be muted for two minutes, after which the icon turns off and any audible alert will sound. • Audio Disabled - Press and hold for one second to prevent or allow any audible alerts. The key’s icon illuminates and flashes amber to indicate that all audible alerts are being suppressed. • High Priority Alerts - (See “NICO® Alert Priorities” on page 56) The SILENCE key’s icon illuminates and flashes red to indicate High Priority Alert is active. The icon alternately flashes red and amber if the audio is disabled and a High Priority Alert is active.

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STOP/CONTINUE REBREATHING key. Press to start NICO® monitoring and the automatic rebreathing process. Subsequent presses will stop (amber indicator illuminated) or continue (amber indicator off) the rebreathing process. Press and hold for two seconds to reset the NICO® algorithm; the C.O. value and averaging filter will be cleared. The STOP/CONTINUE REBREATHING key will be amber and inactive in Respiratory Mechanics mode.

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AC Mains Power Indicator. This icon illuminates green to indicate AC Mains power is applied to the monitor. To illuminate the icon, the monitor must be plugged into the AC outlet and the monitor’s rear panel power switch must be on (“|”).

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OPERATE/STANDBY key. Press this key to turn the monitor on. If connected to the AC outlet, the monitor uses AC power, otherwise it powers up using its internal battery (provided the battery is charged). Press the OPERATE/STANDBY key again to put the monitor into Standby mode (if using AC power) or to turn it off (if using battery power).

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Kickstand (front and rear). The NICO® monitor can be positioned for better viewing from above or below by extending the kickstand at the front or rear of the monitor.

Rear Panel The NICO ® monitor’s rear panel includes an AC Mains power input module, three RS232 serial communications ports, an analog input/output port, equipotential connector, fan and ventilation slots, and the monitor’s serial number label. These are explained below.

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Symbols

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15

19

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21

18

22

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AC Mains Power Cord Connection. Connect only approved hospital-grade line cords to this connector.

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AC Mains Power Switch. This switch controls the flow of AC current into the NICO® monitor. Press the “|” portion of the switch to supply the monitor with AC power, or the “O” portion of the switch to interrupt the flow of AC power. If supplied with AC power, the monitor illuminates the front panel AC Mains Power Indicator, energizes the fan and recharges the internal battery.

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RS232 Communications Ports. Three 9-pin serial communications ports provide for digital communications with the NICO® monitor. (See “RS232 Communications” ).

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Fan. The fan draws air in through the monitor. Do not block the fan’s air intake slots.

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Serial Number Label. The NICO® monitor’s serial number is shown here. Refer servicing to qualified personnel.

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Power cord retaining clip. If desired, remove the screw, slip the cord through the clip and insert and tighten the screw. Use only the supplied screw to secure the clip.

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Equipotentiality. Connection to the monitor’s chassis (earth ground system).

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Analog Input/Output Port. This 15-pin connector provides analog signal output capability for the NICO® monitor (Input reserved for future use).

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Ventilation Slots. Do not block the air ventilation slots.

Symbols Th es e sy mb ols ma y b e f ound on t he N I CO ® mon it or, i ts se ns ors, a cc es sori es a nd documentation.

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Patient Isolation Identifies the patient isolation connection as type BF.

Single Patient Use Treat in accordance with protocol for “single patient use” items.

AC Mains Power Switch “|” ON-connection to mains; “O” OFF-disconnection from mains

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AC/Battery Operation

Mains Fuse Rating Mains rating for replacement fuses

Equipotentiality Connection to monitor’s chassis.

Separate collection Take appropriate steps to ensure that spent batteries are collected separately when disposed of. This symbol is found on the internal battery and the monitor enclosure.

Heavy Metal Content Indicates heavy metal content, specifically lead. This symbol is found on the internal battery and the monitor enclosure.

250V

Pb

Recyclable item This symbol is found on the internal battery and the monitor enclosure.

AC/Battery Operation The NICO ® monitor is designed to be operated from AC Mains power. An internal battery provides uninterrupted monitoring and trending capability for short periods (no more than 45 minutes) if the AC power is removed.

AC Mains Operation

To operate NICO® from AC Mains power:

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Plug the line cord into the rear panel connector and the AC Mains power outlet.

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Set the rear panel power switch to the On “|” position. • The front panel AC Mains Power indicator illuminates. • The monitor’s fan turns on. • The internal battery starts to recharge. Operate /Standby

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Battery Operation

Press the front panel Operate/Standby key to turn the monitor on and off.

The NICO® monitor automatically switches to battery power from AC Mains power if the AC source is removed. A fully charged battery will power the monitor for up to 45 minutes. While on battery power, NICO® displays a battery icon that “drains” as power is consumed.

Battery icon shows capacity

full

half

depleted

The battery icon starts to flash when approximately 5 minutes of battery power remain. An audible alert tone also sounds. Re c on n e ct to A C M ai ns pow e r o r the m on it or w i ll automatically shut off. A depleted battery may require 12-16 hours to fully recharge. To operate NICO® on battery power:

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Unplug the line cord or set the rear panel power switch to the Off “O” position. • The front panel AC Mains Power indicator turns off.

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Press the front panel Operate/Standby key to turn the monitor on and off.

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NICO® Parameter List

NICO® Parameter List Cardiac Output mode

The NICO® monitor displays the parameters described in this table.

Label

Parameter

Range/Units

Description

Screen Display

C.O.

Cardiac Output

0.5-19.9 L/min

Volume of blood pumped by the heart each minute

All

CO-a

Average Cardiac Output

0.5-19.9 L/min

C.O. averaged value, displayed when the fast-mode cardiac output mode is chosen for large display.

Last Completed Cycle rebreathing curve & Tabular Data

CO-f

Fast-mode Cardiac Output

0.5-19.9 L/min

C.O. unaveraged value, displayed when the average cardiac output mode is chosen for large display.

Last Completed Cycle rebreathing curve & Tabular Data

Cdyn

Dynamic Compliance

0-500 ml/cmH2O

Volume the lungs expand for a given pressure

Numerics & Tabular Data

Note that if the ventilator is set for an inspiratory pause that is detected by NICO, Cdyn becomes Cstat. CI

Cardiac Index

0-9.9 L/min/m2

C.O. divided by body surface area

All

ETCO2

End Tidal Carbon Dioxide

0-150 mmHg 0-20.0 % 0-20.0 kPa

Maximum CO2 plateau value at the end of the breath (reflects alveolar CO2)

Numerics, Respiratory Numerics, CO2/SpO2, SBCO2, Tabular Data & rebreathing curves

Insp CO 2

Inspired Carbon Dioxide

3-50 mmHg 0.4-6.7 % 0.4-6.7 kPa

Maximum CO2 value observed during the baseline portion of the Inspiratory phase of the breath (baseline shift above zero point)

General Message Area (if above 3 mmHg for 10 sec (0.4 % or kPa))

MAP

Mean Airway Pressure

0-100 cmH2O

Mean (average) pressure in the airway throughout the breath

Numerics & Tabular Data

MV

Minute Volume

2-40 L/min Adult

Volume (in liters) of gas delivered to the patient per minute

Numerics, Respiratory Numerics & Tabular Data

MV alv

Alveolar Minute Volume

0.05-16 L/min

MV less deadspace (wasted) ventilation

Numerics, Respiratory Numerics & Tabular Data

PCBF

Pulmonary Capillary Blood Flow

0.5-19.9 L/min

Portion of the cardiac output that is effective in gas exchange

3 min Cycle in Progress rebreathing curve & Tabular Data

PeCO2/ FeCO2

Mixed expired CO2

0-100 mmHg, 0-13.2 kPa or %

Volume weighted average CO2 in the breath

Respiratory Numerics & Tabular Data

PEEP

Positive End Expiratory Pressure

0-99 cmH2O

Pressure in the lungs at the end of expiration

Numerics, Flow/ Pressure & Tabular Data

PEF

Peak Expiratory Flow

2-180 L/min

Highest absolute flow rate during expiration

Tabular Data

PIF

Peak Inspiratory Flow

2-180 L/min

Highest absolute flow rate during inspiration

Tabular Data

PIP

Peak Inspiratory Pressure

0-120 cmH2O

Peak (highest) pressure in the airway during inspiration

Numerics, Flow/ Pressure & Tabular Data

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NICO® Parameter List

Label

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Parameter

Range/Units

Description

Screen Display

Pulse Rate

30-250 bpm

Number of pulse beats per minute

Numerics, CO2/SpO2 & Tabular Data

Raw

Airway Resistance

0-100 cmH2O/L/sec

Pressure required to cause gas flow at a given rate

Numerics & Tabular Data

RR

Respiration Rate

2-120 br/min

Number of breaths per minute

Numerics, CO2/SpO2 & Tabular Data

RSBI

Rapid Shallow Breathing Index

0-1000 br/min/L

Respiratory rate divided by average spontaneous tidal volume (only calculated when RR < 57)

Respiratory Numerics & Tabular Data

SpO2

Oxygen Saturation

0-100 %

Oxyhemoglobin as a percentage of total hemoglobin less dysfunctional hemoglobin

Numerics, CO2/SpO2, Tabular Data & rebreathing curves

SV

Stroke Volume

0-250 ml

Volume of blood pumped by the heart each beat

All

SVI

Stroke Volume Index

0-125 ml

Stroke volume divided by body surface area

Tabular Data

SVR

Systemic Vascular Resistance

0-5000 dynes sec/ cm5

Resistance exerted by the blood vessels on blood flow and is an indicator of left ventricular afterload.

SVR Calculation & Tabular Data

SVRI

Systemic Vascular Resistance Index

0-5000 dynes sec/ cm5

SVR normalized to body surface area

Tabular Data

VCO2

Carbon Dioxide Elimination

0-3000 ml/min

Volume of CO2 eliminated through the breath each minute

Numerics, Respiratory Numerics, SBCO2, Tabular Data & rebreathing curves

Vd Aw

Airway deadspace

0-500 ml

Includes added mechanical deadspace proximal to the flow sensor

Respiratory Numerics, SBCO2, Tabular Data

Vd/Vt

Deadspace to tidal volume ratio

0-1.00 ml

(PaCO2-PeCO2)/PaCO2

Respiratory Numerics & ABG Data Entry

Vd alv

Alveolar deadspace

0-500 ml

Difference between physiologic and airway deadspace

Respiratory Numerics & ABG Data Entry

Vt alv

Alveolar tidal volume

0-2400 ml

Tidal volume less airway deadspace

Respiratory Numerics, SBCO2 & Tabular Data

Vte

Expired Tidal Volume

200-3000 ml

Volume of gas exhaled per breath

Respiratory Numerics, Flow/Pressure & SBCO2

Vte-m

Expired Tidal Volume mechanical

200-3000 ml

Volume of mechanically exhaled gas, per breath

Tabular Data

Vte-s

Expired Tidal Volume spontaneous

200-3000 ml

Volume of spontaneously exhaled gas, per breath

Tabular Data

Vti

Inspired Tidal Volume

200-3000 ml

Volume of gas inhaled per breath

Respiratory Numerics, Flow/Pressure & SBCO2

Vti-m

Inspired Tidal Volume mechanical

200-3000 ml

Volume of mechanically inhaled gas, per breath

Tabular Data

Vti-s

Inspired Tidal Volume spontaneous

200-3000 ml

Volume of spontaneously inhaled gas, per breath

Tabular Data

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NICO® Parameter List

Respiratory Mechanics mode

The NICO® monitor displays the parameters described in this table.

Label

Parameter

Range/Units

Description

Screen Display

Cdyn

Dynamic Compliance

0-500 ml/cmH2O

Volume the lungs expand for a given pressure

Numerics & Tabular Data

ETCO2

End Tidal Carbon Dioxide

0-150 mmHg 0-20.0 % 0-20.0 kPa

Maximum CO2 plateau value at the end of the breath (reflects alveolar CO2)

All

I:E

I:E Ratio

1:9.9 or 4:1

Ratio of inspiratory time (ti) to expiratory time (te)

Flow/Pressure

MAP

Mean Airway Pressure

0-100 cmH2O

Mean (average) pressure in the airway throughout the breath

Numerics & Tabular Data

MV

Minute Volume

0.4-40 L/min adult 0.06-30 L/min pedi. 0.01-5 L/min neonatal

Volume (in liters) of gas delivered to the patient per minute

All except Flow/ Pressure & Loops

MV alv

Alveolar Minute Volume

0-16 L/min adult 0-8 L/min pediatric 0-4 L/min neonatal

MV less deadspace (wasted) ventilation

Numerics & Tabular Data

NIP

Negative Inspiratory Pressure

0 to -120 cmH2O

Maximum negative pressure during inspiratory cycle

Loops

PeCO2/ FeCO2

Mixed expired CO2

0-100 mmHg, 0-13.2 kPa or %

Volume weighted average CO2 in the breath

Numerics, SBCO2 & Tabular Data

PEEP

Positive End Expiratory Pressure

0-99 cmH2O

Pressure in the lungs at the end of expiration

Numerics, Flow/ Pressure & Tabular Data

PEF

Peak Expiratory Flow

2-180 L/min adult 0.5-100 L/min pedi. 0.25-25 L/min neo.

Highest absolute flow rate during expiration

Loops & Tabular Data

PIF

Peak Inspiratory Flow

2-180 L/min adult 0.5-100 L/min pedi. 0.25-25 L/min neo.

Highest absolute flow rate during inspiration

Loops & Tabular Data

PIP

Peak Inspiratory Pressure

0-120 cmH2O

Peak (highest) pressure in the airway during inspiration

Numerics, Flow/ Pressure & Tabular Data

Pulse Rate

30-250 bpm

Number of pulse beats per minute

All

Airway Resistance

0-100 cmH2O/L/sec adult/pediatric

Pressure required to cause gas flow at a given rate

Numerics & Tabular Data

Raw

0-500 cmH2O/L/sec neonatal RR

Respiration Rate

2-120 br/min adult 2-150 br/min pedi. 10-150 br/min neo.

Number of breaths per minute

All

RSBI

Rapid Shallow Breathing Index

0-1000 br/min/L (adult only)

Respiratory rate divided by average spontaneous tidal volume (only calculated when RR < 57)

Loops

SpO2

Oxygen Saturation

0-100 %

Oxyhemoglobin as a percentage of total hemoglobin less dysfunctional hemoglobin

All

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Principles of Operation

Label

Parameter

Range/Units

Description

Screen Display

VCO2

Carbon Dioxide Elimination

1-3000 ml/min adult/pediatric

Volume of CO2 eliminated through the breath each minute

All except Flow/ Pressure & Loops

0-300 ml/min neonatal Vd Aw

Airway deadspace

0-500 ml

Includes added mechanical deadspace proximal to the flow sensor

Numerics, SBCO2, Tabular Data

Vd/Vt

Deadspace to tidal volume ratio

0-1.00 ml

(PaCO2-PeCO2) / PaCO2

Numerics, SBCO2 & ABG Data Entry

Vd alv

Alveolar deadspace

0-500 ml

Difference between physiologic and airway deadspace

Numerics, SBCO2 & ABG Data Entry

Vt alv

Alveolar tidal volume

0-2400 ml adult 0-1200 ml pediatric 0-160 ml neonatal

Tidal volume less airway deadspace

Numerics, SBCO2 & Tabular Data

Vte

Expired Tidal Volume

200-3000 ml adult 30-400 ml pediatric 1-100 ml neonatal

Volume of gas exhaled per breath

All except Flow/ Pressure & Loops

Vte-m

Expired Tidal Volume mechanical

200-3000 ml adult 30-400 ml pediatric 1-100 ml neonatal

Volume of mechanically exhaled gas, per breath

Tabular Data

Vte-s

Expired Tidal Volume spontaneous

200-3000 ml adult 30-400 ml pediatric 1-100 ml neonatal

Volume of spontaneously exhaled gas, per breath

Tabular Data

Vti

Inspired Tidal Volume

200-3000 ml adult 30-400 ml pediatric 1-100 ml neonatal

Volume of gas inhaled per breath

All except Flow/ Pressure & Loops

Vti-m

Inspired Tidal Volume mechanical

200-3000 ml adult 30-400 ml pediatric 1-100 ml neonatal

Volume of mechanically inhaled gas, per breath

Tabular Data

Vti-s

Inspired Tidal Volume spontaneous

200-3000 ml adult 30-400 ml pediatric 1-100 ml neonatal

Volume of spontaneously inhaled gas, per breath

Tabular Data

Principles of Operation Non-Invasive Cardiac Output (NICO)

NICO® calculates cardiac output (C.O.) non-invasively based on respiratory gas analysis, using a technique known as “differential Fick partial rebreathing.” The key to this technique is a NICO Sensor™, consisting of a rebreathing valve and a combined CO 2/Flow sensor placed in the breathing circuit. The NICO Sensor™ is placed into the ventilator circuit between the patient elbow and ventilator wye. The rebreathing valve is automatically controlled by the monitor. When the valve is activated, the flow of the inspired and expired gas is diverted through a rebreathing NICO Loop.™ When the valve is deactivated, this additional rebreathing volume is bypassed and normal ventilation resumes. Every three minutes, a baseline, rebreathing and stabilization phase occurs. (See “The NICO® Cycle” on page 27.) A non-invasive cardiac output calculation is made following the end of each three minute cycle. The calculation is based on the changes induced in CO2 elimination and end tidal CO2 in response to the rebreathing volume. The increase in end tidal CO2, which reflects the increase in PaCO2, is usually 3-5 mmHg (0.40.67 kPa) and returns to baseline in less than 30 seconds. The Fick equation using CO 2 as an indicator states that cardiac output is equal to CO2 elimination divided by the venous-arterial difference in the CO2 content: VCO2/(CvCO2-CaCO2). The partial rebreathing method yields a differential form of the Fick equation, eliminating the need to measure mixed venous CO 2 (assumed constant during the rebreathing period and therefore cancels out of the equation). This indirect Fick method is then corrected for shunt,

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based on the Nunn’s iso-shunt curves using SpO2 (or entered PaO2) and a user-entered value for FiO2 (INSP O2).

Carbon Dioxide (CO2)

NICO ® uses the CAPNOSTAT® CO 2 Sensor to measure CO2 by using the infrared absorption technique. The principle is based on the fact that CO 2 molecules absorb infrared (IR) light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO 2 concentration. When an IR beam is passed through a gas sample containing CO2 , the electronic signal from the photodetector (which measures the remaining light energy) can be obtained. This signal is then compared to the energy of the IR source and calibrated to accurately reflect CO2 concentration in the sample. To calibrate, the photodetector’s response to a known concentration of CO2 is stored at the factory in the monitor’s memory. A reference channel accounts for optical changes in the sensor, allowing the system to remain in calibration without user intervention.

Flow and Pressure

Flow and pressure measurements in the NICO® monitor are made by a fixed orifice differential pressure pneumotachometer. Respired gas flowing through the flow sensor causes a small pressure drop across the two tubes connected to the sensor. This pressure drop is transmitted through the tubing to a differential pressure transducer located inside the monitor, and is correlated to flow according to the factory stored calibration. User calibration is not required due to the ability of the plastic injection mold to repeatedly produce precision flow sensors. The pressure transducer is automatically “zeroed” to correct for changes in ambient temperature and electronics. The NICO ® monitor system software compensations allow accurate flow and volume measurements in the presence of high oxygen concentrations, anesthetic gases and helium-oxygen mixtures. When compensated, gas density and viscosity effects do not cause significant errors in flow measurement.

Carbon Dioxide Elimination (VCO2)

Carbon dioxide elimination (VCO2) is a key measurement for NICO® calculations. It is calculated based on a mathematical integration of the measured flow and CO2 signals. These signals are obtained from practically the same point at the patient’s airway, thereby insuring optimal accuracy. Both the flow and CO2 sensors are integral components of the NICO Sensor™.

Oxygen Saturation (SpO2) & Pulse Rate

Oxygen saturation (SpO2) is used by the NICO® monitor to calculate the shunt correction of the NICO® calculation, and the pulse rate is used to calculate stroke volume. SpO2 is determined using sensors containing red and infrared light emitting diodes (LEDs). The light from each LED is beamed through a pulsating vascular bed such as the patient’s finger or toe. The remaining light not absorbed by the tissue reaches a photodiode light receptor in the sensor. Oxygen saturated blood absorbs different amounts of light at each wavelength as compared to unsaturated blood. Therefore, the amount of light absorbed by the blood in each pulse can be used to calculate oxygen saturation. NICO ® is calibrated to display “functional” saturation. This differs from the “fractional” saturation value displayed by most co-oximeters. Functional saturation represents the amount of oxyhemoglobin as a percentage of the hemoglobin that can be oxygenated. Dysfunctional hemoglobins, (COHb and METHb) are not included in the measurement of functional saturation. • Functional Saturation = HbO2/100-(COHb+METHb); HbO2 is fractional hemoglobin, COHb is carboxyhemoglobin, and METHb is methemoglobin. Pulse Rate, derived from the pulse oximetery sensor, is calculated by measuring the time interval between the peaks of the infrared light waveform. The inverse of this measurement is displayed as pulse rate.

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Areas of the Display

Navigating in Cardiac Output mode Areas of the Display The major sections of the Cardiac Output mode screen are identified below. Stroke Volume (SV) and Cardiac Index (CI) are displayed in all views. A battery icon also appears if on battery power.

Cardiac Output (C.O.) value is displayed in all views. The CObar™ confidence indicator is replaced by FAST MODE when in fast mode.

A General Message area for status, alert and error information. Displayed in all views (here shown blank). A Cardiac Output Message area for C.O. information is displayed in all views. The Rebreathing Bar is displayed during the rebreathing portion of the cycle.

The lower half of the display presents trend, waveform, respiratory and numeric data to the user. Various data entry, setup and alert menus are also presented here. Use the KNOB and the MENU and DATA ENTRY keys to select the various displays.

Navigating the Display System Use the KNOB, MENU, and DATA ENTRY keys to navigate the NICO® display system (as outlined in the following sections).

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KNOB selectable Monitoring Screens

KNOB selectable Monitoring Screens The KNOB is used to page through monitoring screens, scroll through menus and make selections, and to change or enter values. The KNOB is generally turned to access different monitoring screens and to highlight menu options, and pressed to accept or change selections. C.O. Trend Screen

TURN

PUSH

Rebreathing Curves Screen

PUSH

CO2/SpO2 Screen (No Options)

Flow/Pressure Screen (No Options)

Numerics Screen (No Options)

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KNOB selectable Monitoring Screens

KNOB Selectable Respiratory Screens

The following Respiratory Screens are available in the monitoring mode only when activated. Press the MENU key and select RESP SCREENS from the SELECT A SCREEN menu by turning and then pressing the KNOB. From the ADD RESPIRATORY SCREENS menu, highlight and then select which screens will appear in the base monitoring mode by turning and then pressing the KNOB. When enabled, selected screens can be displayed by turning the KNOB while viewing any monitoring screen.

Respiratory Numerics TURN

Flow Volume Loop and Pressure Volume Loop

Single Breath CO2 Waveform

VCO2/MValv Trend

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MENU key Screen Displays

MENU key Screen Displays Press the MENU key to activate the SELECT A SCREEN menu and illuminate the key’s green icon. Press the key again to return to the previously displayed screen. From the SELECT A SCREEN menu turn the KNOB to highlight the screen you wish to display. Press the MENU key or the KNOB to display that selected screen.

1 PUSH

3

PUSH

2 TURN

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DATA ENTRY key Screen Displays

DATA ENTRY key Screen Displays Press the DATA ENTRY key to activate the DATA ENTRY screen and illuminate the key’s green icon. Press the key again to return to the previously displayed screen. From the DATA ENTRY screen, you can enter patient information including height, weight and respiratory gas mixture, and access the ABG DATA ENTRY screen. (See “Entering Patient Data” on page 28 for details.)

1 PUSH

2

3 TURN

PUSH

4

5 TURN TO ADJUST

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PUSH TO ACCEPT

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DATA ENTRY key Screen Displays

ABG Data Entry Screens

From the DATA ENTRY screen, select ABG DATA ENTRY. Turn and press the KNOB to enter PaCO2, PaO2, and Hemoglobin entry screens. (See “Entering Patient Data” on page 28 for details.)

1

PUSH

3

2 TURN

PUSH

4

5 TURN TO SELECT

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