VentCheck™ Model 101 Users Manual April 2000

About this manual This manual is written for clinical personnel using the VENT✔ (VentCheck™) Handheld Respiratory Mechanics Monitor, Model 101, and the flow 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. VentCheck and the VENT✔ logo are trademarks of Novametrix Medical Systems Inc.

VENT✔ Technical Description Per requirements of IEC 601-1, VENT✔ is classified as class II equipment, internally powered, with type BF applied part, and an enclosure protection rating of IPX1. Transport/Storage: -10 to +55° C (14-131° F), 10-95% R.H. non-condensing Operating Conditions: +10 to +40° C (50-104° F), 10-90% R.H. non-condensing The VENT✔ (VentCheck™) Handheld Respiratory Mechanics Monitor, Model 101, contains no user serviceable parts. Refer servicing to qualified service personnel. (See “Accessories” on page 21 for listings of the Service Manual and Service Test kit for use by technical personnel.)

Declaration of Conformity with European Union Directive The Authorized Representative for Novametrix equipment is: D.R.M. Green European Compliance Services Limited, Oakdene House, Oak Road, Watchfiled Swindon, Wilts SN6 8TD United Kingdom

Manual Revision History 31-Jul-97 Release at Rev. 00. 17-Oct-97 Rev. 01. Including software release version 1.1. 30-Oct-97 Rev. 02. Including software release 1.2. 13-Apr-00 Rev. 03. R-N746

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Table of Contents General Description... 5 Indications for Use... 5 Contra-indications... 5 Principles of Operation... 5 Patient Safety... 6 Warnings... 6 Cautions... 7 Notes... 7 Preparation for Use... 8 Getting Acquainted... 8 Keypad Controls and Indicators... 9 Symbols... 9 Power supply options... 9 Battery Installation... 10 External Battery Charger... 11 Features Connector

... 11

Monitor Operation... 12 Power On/Off... 12 Flow Sensor... 12 Patient Connection... 13 Patient Disconnect... 14 Screen Display Flowchart

... 14

DATA Display Screens... 15 GRAPH Display Screens... 16 System Errors... 16 Parameter Alerts... 17 Battery Alert... 17 Cleaning and Disinfecting... 17 Parameter List

... 18

Specifications... 19 Accessories... 21 Warranty... 22

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General Description The VENT✔ (VentCheck™) Handheld Respiratory Mechanics Monitor, Model 101, from Novametrix Medical Systems Inc., is an easy-to-operate stand-alone respiratory mechanics monitor. It is intended to be used in patient monitoring environments by technically skilled clinical personnel.

Indications for Use

VENT✔ is indicated for use by technically skilled clinical personnel as a mechanics monitor for mechanically ventilated or spontaneously breathing persons in monitoring environments including the intensive care unit (ICU), the operating room (OR) and in emergency/transport care. The device is intended for shortterm use (nominally 1 hour) and is NOT intended for continuous monitoring. VENT✔ compatible flow sensors are a single patient use devices having fittings that comply with ISO 5356-1 and may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the specification. Pediatric/adult flow sensors are indicated for use with endotracheal tubes with internal diameters of t6 mm. Neonatal flow sensors are indicated for use with endotracheal tubes with internal diameters of d4 mm. Further, for endotracheal tubes with internal diameters of 4.5 to 5.5 mm, in general, neonatal sensors are indicated if the patient weight <10 kg or tidal volume <100 ml, and pediatric/ adult sensors are indicated where patient weight t10 kg and tidal volume t100 ml.

Contraindications

VENT✔ is intended for short-term use (nominally 1 hour) and is NOT intended as a continuous monitoring device. VENT✔ does NOT compensate for the presence of high oxygen concentrations, anesthetic gases or helium-oxygen mixtures. When such mixtures are present, errors in flow measurements may exist.

Principles of Operation

VENT✔ measures the respiratory parameters of flow and pressure. Many other parameters are calculated from the flow and pressure signals, including: volume (tidal and minute), airway resistance, and lung compliance. VENT✔ uses fixedorifice, differential pressure pneumotachs. The pneumotach is the airway flow sensor that converts volumetric flow rate into a differential pressure signal. Gas flowing through the flow sensor causes a small pressure drop across the two ports connected to the sensor. This pressure drop is transmitted through the tubing to the monitor where differential and absolute pressure transducers are located. This pressure drop is correlated to flow according to the factory stored calibration. (The relationship between the volumetric flow-rate and the resulting differential pressure is governed by standard fluid mechanics equations.) User calibration is not required because of the ability of the plastic injection mold to produce precision flow sensors. Empirical calibration for the specific pneumotach type (pediatric/adult, neonatal, etc.) is performed at the factory and is stored in the monitor. The pressure transducer is automatically "zeroed" to correct for changes in ambient temperature, electronics and position (gravity effects).

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Patient Safety

• Keep the VENT✔ and its accessories clean. Do not operate the VENT✔ when it is wet due to spills or condensation. • Connect only Novametrix Series 3 Flow Sensors to the VENT✔. For maximum performance; keep the pressure sensor ports oriented upward, and keep the sensor clear of moisture and secretions by proper breathing circuit maintenance. • Connect the sensor first to the VENT✔ and then to the patient breathing circuit in order to limit circuit volume loss and to avoid excessive moisture build-up in the flow sensor tubing. • VENT✔ has electrically isolated inputs. Patient leakage current flowing from the instrument to ground is limited to less than 50 PA at 120 V, 60 Hz. Patient isolation is greater than 10 M:, 2500 V rms at 60 Hz. • Where electromagnetic devices (i.e., electrocautery) are used, patient monitoring may be interrupted due to electromagnetic interference. Electromagnetic fields up to 3 V/m will not adversely affect system performance. • VENT✔ contains no user serviceable parts. Refer servicing to qualified service personnel. (See “Accessories” on page 21 for listings of the Service Manual and Service Test kit for use by technical personnel.) • This product and its accessories which have patient contact are latex free.

Warnings

!

WARNING: Indicates a potentially harmful condition that can lead to personal injury.

• Explosion Hazard: Do NOT use the VENT✔ in the presence of flammable anesthetics. Use of this instrument in such an environment may present an explosion hazard. • Electrical Shock Hazard: Always turn the monitor off before cleaning it. Do NOT use a damaged monitor or sensor. Refer servicing to qualified service personnel. • Fire Hazard: The VENT✔ should not be exposed to elevated oxygen levels at elevated pressures. Use in such an environment may present a fire hazard. • Failure of Operation: If the monitor fails to respond as described, do not use it until the situation has been corrected by qualified personnel. • Do not apply tension to the sensor tubing while connected to a patient breathing circuit, as accidental extubation may result. • Do not position the flow sensor’s tubing in any manner that may cause entanglement or strangulation. • Use the optional external battery charger in non-patient areas only.

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Cautions

!

CAUTION: Indicates a condition that may lead to equipment damage or malfunction.

• Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner. • Electrical Shock Hazard: Always turn the monitor off before cleaning. Do NOT use a damaged monitor. • Do NOT use a damaged flow sensor. • Do NOT immerse the monitor or sensors in liquids. • Do NOT sterilize the monitor or the sensors. • No user serviceable parts inside. Refer servicing to qualified service personnel. • Operate at temperatures between +10° C to +40° C (50-104° F), < 90% relative humidity (non-condensing). • Avoid storing the monitor at temperatures less than -20q C or greater than +55q C (<-4q F or >131q F).

Notes NOTE Indicates points of particular interest or emphasis and intended to provide for more efficient or convenient operation. • The VENT✔ operates with Novametrix Series 3 Flow Sensors only. • The VENT✔ performs an automatic zero (self calibration) periodically and as needed. During this time, monitoring is interrupted for less than three seconds. • The automatic zero can be manually initiated by simultaneously pressing the DATA and GRAPH keys. After changing the sensor from Adult to Neonatal (while the VENT✔ is operational), wait 30 seconds then perform an automatic zero. • This product and its accessories which have patient contact are free of latex. • The C20/C Compliance Ratio (neonatal) parameter is not supported. • To determine the VENT✔ software version, turn the monitor on. During the self test performed at power up, the software level is shown on the third line as “main-101-xx”, where “xx” is the software version. • Some VENT✔ monitors were produced with the statement “Use only Novametrix approved devices, 13 VDC, 1A” located on the label at the Flow Sensor Input Connector. This erroneous statement does NOT apply to the VENT✔ monitor and should be ignored.

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Preparation for Use Getting Acquainted

The VENT✔ Handheld Respiratory Mechanics Monitor, Model 101 is shown below.

Front View

Keypad & Display

Top View

Connect Series 3 Flow Sensor

Flow Sensors

nt tie Pa o T or lat t ni e V To Neonatal Sensor #6718/6720

Pediatric/Adult Sensor #6717

Side/Bottom View

Features Connector Quick Guide

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Battery Access Compartment

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Keypad Controls and Indicators

1 2 3 4

POWER

GRAPH

DATA

NEO

B

A

#

Key

Action

Function

1

POWER

Press

Turns VENT✔ on/off.

2

GRAPH

Press

Display Graph Screens. Additional presses causes VENT✔ to sequence through available Graph Screens.

3

DATA

Press

Display Data Screens. Additional presses causes VENT✔ to sequence through available Data Screens.

Press

Turns display backlight on/off.

4

Press & Hold

Adjusts contrast/viewing angle of display (1 step/sec.)

A

None

Illuminated if powered from battery Green; battery charged Yellow flashing slowly; capacity getting low Red flashing quickly; exhausted in 10-15 min.

None

Illuminates when a Neonatal sensor is connected.

B

NEO

Symbols Symbol

Description Patient Isolation Identifies patient isolation connection as type BF.

!

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Attention Consult manual for detailed information.

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Power supply options

The VENT✔ can be powered from seven “AA” disposable alkaline batteries, or a rechargeable battery. Battery capacity is shown in the chart below; it may be reduced in colder temperatures or with power cycling, and slightly increased if VENT✔ is operated with its backlight off. Standard AA alkaline batteries (7 ea. - disposable)

Optional Rechargeable battery, (NiMH 7.2 vdc)

8 hours

12 hours

Recharge Time

n/a

4.5 hours

Catalog Number

400038 (battery) 6862-00 (case)

400043

Power Source

Capacity, continuous

AA Alkaline Batteries. To power VENT✔ from AA alkaline batteries, insert seven disposable alkaline batteries (Panasonic AM3X or equivalent) into the Battery Case (Cat. No. 6862-00) following the polarity markings on the case.

!

WARNING: Do not recharge or incinerate alkaline batteries. Attempting to do so may cause the batteries to leak or explode.

Rechargeable Battery. VENT✔ can operate from the optional NiMH rechargeable battery. If a rechargeable battery has not been used for three months or more, recharge it before use.

!

WARNING: Battery can explode, leak or catch on fire if heated or exposed to fire or high temperatures.

NOTE: • New batteries, or batteries stored for extended periods of time may need to be fully charged and discharged up to five (5) times before performing to full capacity. • With a new battery, or a battery that has not been used for 30 days, charge the battery for 24 hours prior to use. • Refer to instructions packaged with rechargeable battery for complete operating instructions. Additional Battery Information. • Dispose of batteries in accordance with local laws. • Do not mix battery types (e.g. disposable and rechargeable AA batteries).

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• VENT✔ may not power up if the batteries are nearly depleted.

Battery Installation

To install or remove the battery, grasp the finger grips on each end of the VENT✔ battery cover. Squeeze together and pull so that the hinged cover opens. The battery is keyed and can be installed in only one orientation (see illustration inside battery compartment). The contacts should go in first and be located toward the top left of the monitor. Close the battery cover before operating the monitor. Connect only Novametrix approved devices

Hinged Battery Compartment Cover

Swing battery cover open

Finger Grips

External Battery Charger

An optional external charger for the NiMH rechargeable battery is available. The external charger allows the battery to be recharged outside of the VENT✔ monitor. • The external charger is for use with the rechargeable NiMH battery only. • In a non-patient area, connect the external charger to an AC source. Remove the battery from the VENT✔ and insert it into the external charger. The battery will be fully charged in approximately 4.5 hours. • Refer to the instructions supplied with the charger for additional information.

! Features Connector

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WARNING: The external battery charger should NOT be operated near or in close proximity to patients and/or other medical equipment in operation.

The VENT✔ features connector is for use only with future optional Novametrix accessories. The connector meets the patient safety requirements set forth by the safety agencies as labelled on the VENT✔ monitor.

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Monitor Operation Prior to operating the VENT✔ monitor, please note the following; • VENT✔ is intended for short-term use (nominally 1 hour) and is NOT intended as a continuous monitoring device. • VENT✔ does NOT compensate for the presence of high oxygen concentrations, anesthetic gases or helium-oxygen mixtures. When such mixtures are present, errors in flow measurements may exist. • The VENT✔ performs an automatic zero (self calibration) periodically and as needed. During this time, monitoring is interrupted for less than three seconds. The instructions below assume the VENT✔ has a charged battery installed and that no flow sensor is connected. Use of equipment other than mentioned here may yield different results.

Power On/Off

1. Press the POWER key to turn VENT✔ on (or off). 2. Verify both the NEO and battery indicators illuminate as part of the self-test performed at power up. 3. Press and hold the LAMP key to adjust the contrast/viewing angle of the display. 4. If desired, press the LAMP key to turn the display backlight on/off.

POWER

GRAPH

DATA

NEO

5. Verify INSERT FLOW SENSOR message appears.

Flow Sensor

6. Select a Series 3 Flow Sensor based on the patient type. - #6717, Pediatric/Adult sensor adds approximately 6.5 cc of deadspace. - #6718/6720, Neonatal sensors add approximately 0.8 cc of deadspace. ET Tube Size t6 mm 4.5 to 5.5 mm

d4 mm

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Series 3 Flow Sensor • Pediatric/Adult • Pediatric/Adult if weight t10 kg and VT t100 ml • Neonatal if weight <10 kg or VT <100 ml Neonatal

Neonatal Sensor #6718/6720

Pediatric/Adult Sensor #6717

t en a ti P To or t tila en V To

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7. Remove the sensor from the package. Verify the sensor is clean, dry and physically intact with no broken edges or disconnected tubing. 8. Connect the Flow sensor to the VENT✔. • Verify VENT✔ briefly displays the selected sensor type. • Verify the NEO indicator is illuminated only if a neonatal sensor is in use.

Patient Connection

9. After connecting the flow sensor to the VENT✔, place the flow sensor into the breathing circuit proximal to the patient.

NOTE Connect the sensor first to the monitor and then to the patient breathing circuit in order to limit circuit volume loss and to avoid excessive moisture build-up in the flow sensor tubing. • The sensor is best placed between the endotracheal tube and the ventilator circuit wye. • Do NOT position the sensor between the ET tube and the elbow (pediatric/ adult circuit), as this may allow patient secretions to build up in the sensor. • If other airway appliances (e.g., suction adapter, elbow, heat moisture exchanger (HME), CO2 adapter, etc.) are in use, place the flow sensor in the more distal position-away from the patient-closer to the circuit wye. • To prevent “rain-out” and moisture from draining into the sensor, do NOT place the sensor in a gravity dependent position where moisture and secretions may accumulate. • Periodically check the flow sensor and tubing for excessive moisture and/or secretion build-up. • After changing the sensor from Adult to Neonatal (while the VENT✔ is operational), wait 30 seconds then perform an automatic zero by simultaneously pressing the DATA and GRAPH keys. To VENT✔ To ventilator Point tubing upward To VENT✔ Pediatric/Adult Flow Sensor

Point tubing upward

To ventilator

Neonatal Flow Sensor To patient

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Patient Disconnect

VENT✔ does NOT provide audible alarms and will not alert the user to inadvertent disconnection of the flow sensor from either the breathing circuit of the monitor’s sensor input connector.

NOTE To limit circuit volume loss and avoid excessive moisture build-up in the flow sensor tubing, disconnect the flow sensor from the breathing circuit before disconnecting the flow sensor from the monitor. Screen Display Flowchart

10. Press the GRAPH or DATA keys and the most recently viewed data or graph screen appears in the display. Additional key presses cause VENT✔ to sequence through the available data screens as shown below.

1

1 GRAPH

2

DATA

2 GRAPH

3

DATA

3 GRAPH

4

DATA

4 GRAPH

5

5 GRAPH

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DATA

DATA Display Screens

Each of the data screens is shown below.

1 DATA

VOLUME DATA • Spon - spontaneous breath, Mech - mechanical breath. • Values from rolling 8-breath average. • Activity bar is breath-by-breath using Volume Graph scale. PRESSURE DATA • Breath-by-breath reporting.

2 DATA

• If auto-PEEP is detected, the word “auto” appears under PEEP and the display reflects total PEEP present. • Activity bar is breath-by-breath using Pressure Graph scale. TIMING DATA • Breath-by-breath reporting.

3 DATA

• Activity bar is breath-by-breath using Flow Graph scale.

FLOW/VOLUME DATA • Breath-by-breath reporting.

4 DATA

MECHANICS DATA • Breath-by-breath reporting.

5 DATA

• RSBI - Pediatric/Adult sensor in use, blank when Neonatal sensor in use. • Activity bar is breath-by-breath using Flow Graph scale.

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GRAPH

GRAPH Display Screens

Each of the graph screens is shown below. VOLUME GRAPH • Automatically scaled.

1 GRAPH

• Breath-by-breath reporting.

PRESSURE GRAPH • Automatically scaled.

2 GRAPH

• Breath-by-breath reporting.

FLOW GRAPH • Automatically scaled.

3 GRAPH

• Breath-by-breath reporting.

GRAPH

FLOW/VOLUME GRAPH • Automatically F scaled.

4

• 4 breaths overlayed then cleared.

V

• Breath-by-breath.

5 GRAPH

PRESSURE/VOLUME GRAPH • Automatically V scaled. • 4 breaths overlayed then cleared.

P

• Breath-by-breath. • RSBI - Pediatric/ Adult sensor in use, blank when Neonatal sensor in use.

System Errors

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If VENT✔ detects that a system error has occurred, patient monitoring is interrupted and an error me ssage is d isp layed. Co rre cting the e rror condition will clear the error message from the display and monitoring will resume. The CALL SERVICE messages cannot be cleared from the display without power cycling the monitor.

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The following errors are possible;

Error Message

Possible Cause

Corrective Action

CALL SERVICE

Faulty monitor or sensor.

Remove monitor and flow sensor from use. Contact qualified service personnel and note number shown in triangle.

INVALID SENSOR TYPE

Incorrect sensor type connected.

Replace sensor with a valid sensor type, pediatric/adult or neonatal.

Damaged sensor.

Connector is damaged. Replace sensor.

Damaged monitor.

Monitor’s sensor connector is damaged. Remove from use and contact qualified service personnel.

FLOW OUT OF RANGE

Flow rate greater than 180 L/min.

VENT✔ does not operate with flow rates in excess of 180 L/min.

PRESSURE > 120 CM H2O

Pressures >120 cm H2O were detected.

Do not expose monitor/sensor to pressures in excess of 120 cm H2O.

Parameter Alerts

VENT✔ does not provide audible or visible parameter alerts.

Battery Alert

VENT✔ monitors, and indicates to the user, the remaining battery capacity. The battery indicator illuminates GREEN to indicate a charged battery, slowly flashes YELLOW to indicate capacity is getting low, and quickly flashes RED to i nd i ca te t he b at te r y w i l l b e c o m e exhausted within 10-15 minutes. When the battery indicator flashes RED, VERY LOW BATTERY appears in the title stripe area of the display (example at right).

Cleaning and Disinfecting

POWER

GRAPH

DATA

NEO

• Turn VENT✔ off before cleaning. Do not immerse the monitor. Do not attempt to sterilize the monitor. • The monitor can be cleaned and disinfected with solutions such as isopropyl alcohol 70% solution, 2% glutaraldehyde solution, or bleach 10% solution, then wiped with a clean water dampened cloth to rinse and dry before use. • Treat Series 3 Flow Sensor in accordance with established protocol for single-patient use items.

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Parameter List Parameters reported by the VENT✔ are summarized below. Abv.

Units

Cdyn

ml/cmH2O

I:E MAP

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Parameter Dynamic Compliance Inspiratory:Expiratory Ratio

cmH2O

Mean Airway Pressure

MV

Liters

Minute Volume

NIP

cmH2O

Negative Inspiratory Pressure

PEEP

cmH2O

Positive End Expiratory Pressure

PEF

LPM (L/min)

Peak Expiratory Flow

PIF

LPM (L/min)

Peak Inspiratory Flow

PIP

cmH2O

Peak Inspiratory Pressure

Plat

cmH2O

Plateau Pressure

Raw

cmH2O/L/sec

Airway Resistance

RR

br/min

Respiratory Rate

RSBI

br/min/L

Rapid Shallow Breathing Index

Te

sec

Expiratory Time

Ti

sec

Inspiratory Time

VT

ml

Tidal Volume (Averaged)

VTi

ml

Tidal Volume Inspiratory

VTe

ml

Tidal Volume Expiratory

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Specifications Below are specifications for the Novametrix VENT✔ Handheld Respiratory Mechanics Monitor, Model 101. These specifications are listed for informational purposes only, and are subject to change without notice.

Principle of Operation

Fixed orifice differential pressure pneumotach. No calibration required.

Flow Sensors

Series 3 Flow Sensors, Single Patient Use ET Tube Size t6 mm 4.5-5.5 mm d4 mm

Series 3 Flow Sensor

Catalog No.

Pediatric/Adult

6717

Pediatric/Adult if weight t10 kg and VT t100 ml Neonatal if weight <10 kg or VT <100 ml

6717 6718/6720

Neonatal

6718/6720

Flow: • Range: Adult Sensor: r 2 to 180 L/min. Range: Neonatal Sensor: r 0.25 to 35 L/min. Accuracy: Greater of r 0.5 L/min or 5% of reading (pediatric/adult sensor). Greater of r 0.125 L/min or 5% of reading (neonatal sensor). Pressure: • Range: 120 to 120 cmH2O Accuracy: Greater of r 0.5 cmH2O or 2% of reading. Respiratory Rate • Range: 0 to 120 br/min Accuracy: r1 br/min Resolution: 1 br/min Sensor Type Identification: Automatic. Automatic Barometric Pressure Compensation: 400-800 mmHg.

Physical

VENT✔ monitor • Size (maximum height, width, depth): 20 u 9.5 u 4.8 cm (8 u 3.75 u 1.875 in.). • Weight (typical): without battery: 370 grams, (13 oz.), with alkaline battery pack: 595 grams (21 oz.), with rechargeable battery: 710 grams (25 oz.). • Operating Environment: +10 to +40° C (50-104° F), 10 to 90% relative humidity non-condensing. • Transport/Storage Environment: -10 to +55° C (14-131° F), 10 to 95% relative humidity non-condensing.

Display

Liquid Crystal Display • 128 u 64 pixels, 2.5 u 1.25 inches. • Adjustable contrast with backlight and plastic shield.

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Indicators

LED indicators • Remaining battery capacity (green, yellow, red). • Neonatal flow sensor connected (green).

Alerts

Alerts for measured patient parameters: None. Very low battery alert: audible and visual.

AA Alkaline batteries

Panasonic AM3X or equivalent, (7 required). • Type: AA, Alkaline, 1.5 vdc, 1500 mAH. • Continuous battery life: 8 hours minimum at 21 qC (70 qF). • Up to 85% capacity remaining after 4 years storage at 21 qC (70 qF). • Recharge: Disposable, do not recharge.

Rechargeable Battery:

NiMH • Type: Nickel-Metal-Hydride (NiMH), 7.2 vdc, 2400 mAH, >250 cycles. • Continuous battery life: 12 hours minimum at 21 qC (70 qF). • Up to 70% capacity remaining after 30 days storage at 21 qC (70 qF). • Charge Conditions: 0 to 45 qC (32 to 113 qF). • Discharge Conditions: -20 to 50 qC (-4 to 122 qF). • Recharge time: 1.5 hr with external charger.

External Battery Charger:

Charger compatible with NiMH rechargeable battery • Storage Conditions: -40 to +70 qC (-40 to 158 qF). • Operating Conditions: 0 to 50 qC (32 to 122 qF); optimum +25qC (77 qF). • Recharge time: 1.5 hour typical

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