Model 800 EasyNeb Series Operators Manual

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Copyright ©2003 Puritan-Bennett Corporation. 800 Series and EasyNeb are trademarks of Puritan-Bennett Corporation. All rights reserved. The EasyNeb nebulizer is manufactured in accordance with Puritan-Bennett proprietary information. The information contained in this manual is the sole property of Puritan-Bennett and may not be reproduced or copied without the permission of the company. This manual may be revised or replaced by Puritan-Bennett at any time and without notice. Users should always ensure that they have the most current version applicable to their equipment. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The equipment described in this document should only be used by trained professionals. Puritan-Bennett’s sole responsibility with respect to such equipment, and its use, is as stated in the limited warranty provided with such equipment. Nothing in this manual shall limit or restrict in any way Puritan-Bennett’s right to revise or otherwise change or modify the equipment described herein, without notice. In the absence of an express, written agreement to the contrary, Puritan-Bennett has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment described herein.

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Preface

Warnings, Cautions, and Notes 1 Warnings, cautions, and notes Warning • Certain aerosolized medications may contain alcohol, which can ignite in air enriched with oxygen under high pressures. In case of fire or a burning smell, immediately disconnect the nebulizer and ventilator from the oxygen supply and electrical power source. • To avoid a fire hazard, do not use the nebulizer in an incubator. • To ensure optimum nebulizer operation and drug administration, consult the drug manufacturer regarding suitability for nebulization. • Do not leave the patient unattended during nebulization. • Do not use the nebulizer for long term continuous nebulization. • The user is responsible for the correct operation and maintenance of the EasyNeb nebulizer according to these instructions. • To avoid an electrical hazard, do not expose the power supply AC input area to liquid. If liquid splashes onto the power supply, remove the power cord from the wall outlet. Completely dry the power supply, cords, and connections before returning to service.

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Warnings, Cautions, and Notes Caution • To avoid mechanical or electrical damage, do not drop or hit the nebulizer or timer system. To minimize the probability of damage or disconnection, position the nebulizer assembly close to the ventilator during transport, and do not pull on the nebulizer assembly to transport the ventilator. In case of impact, inspect the nebulizer and do not use if damage is visible. • To avoid damage to the piezoelectric crystal, do not operate the nebulizer without buffer water and do not touch the crystal with any metal objects. • If necessary to ensure that the nebulizer is operating properly, run the functional test described in this manual. • Do not immerse the nebulizer in liquid. • Federal law (US) restricts the sale of this device to, or by the order of, a physician. • In case of equipment malfunction, return the nebulizer to Puritan-Bennett. Do not attempt to use, repair, or make unauthorized modifications to the nebulizer. • Do not apply adhesive labels to the transparent plastic parts of the nebulizer: adhesives can cause the plastic to become brittle. NOTE: Due to bias flow in the patient circuit during exhalation, a portion of nebulized medication may be lost to atmosphere through the exhalation valve. This effect is generally greater during flow triggering and minimal during pressure triggering.

Customer assistance For further assistance contact Puritan-Bennett Technical Service or your local Puritan-Bennett representative.

Preface This manual provides information needed to operate the 800 Series EasyNeb nebulizer and is intended for use by qualified healthcare personnel. ii

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Contents 1 Warnings, Cautions, and Notes...i 1 Introduction...1-1 1.1 Intended use... 1-1 1.2 Technical description... 1-1 1.3 Controls and signals... 1-2 1.4 Symbols and equipment labels... 1-2

2 Assembly and installation...2-1 2.1 Installing the timer system... 2-2 2.2 Assembling the nebulizer... 2-3 2.3 Assembling the nebulizer to the breathing circuit... 2-6

3 Operation...3-1 3.1 Setting nebulization time... 3-1 3.2 Functional test... 3-1 3.3 Restarting the nebulizer... 3-2

4 Cleaning and inspection...4-1 4.1 Cleaning the nebulizer... 4-1 4.2 Inspection... 4-3

5 Troubleshooting...5-1 A Specifications... A-1 A.1 Particle size distribution... A-4

2 Parts list... B-1

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Figures Figure 2-1: Attaching timer system to support arm socket... 2-2 Figure 2-2: Adding buffer water... 2-3 Figure 2-3: Assembling nebulizer components... 2-4 Figure 2-4: Placing the nebulizer into the holder... 2-5 Figure 2-5: Installing the nebulizer into the ventilator breathing circuit... 2-6 Figure A-1: EasyNeb particle size distribution curve... A-4 Figure B-1: EasyNeb parts... B-3

Tables

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Table 1-1:

EasyNeb nebulizer symbols and labels... 1-2

Table 4-1:

EasyNeb cleaning, disinfection, and sterilization... 4-2

Table 4-2:

EasyNeb inspection points... 4-3

Table 5-1:

EasyNeb troubleshooting procedures... 5-1

Table A-1:

EasyNeb specifications... A-1

Table A-2:

Particle size distribution test results... A-5

Table B-1:

Parts list: 800 Series EasyNeb Nebulizer... B-1

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Introduction

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1.1 Intended use The 800 Series EasyNeb nebulizer is designed to deliver aerosol medications to mechanically-ventilated patients in continuous mode only. EasyNeb is intended for use with 800 Series Ventilator lung ventilation (not anesthetic) breathing systems only. The EasyNeb nebulizer is intended for use by qualified healthcare personnel only.

1.2 Technical description The EasyNeb nebulizer contains a piezoelectric crystal that generates ultrasonic energy, which is transmitted through a buffer water medium to a medication cup. The liquid medication is converted into an aerosol for delivery to the patient. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication. The gas in the ventilator breathing circuit passes through the nebulizer tee, conducting the nebulized medication aerosol plume to the patient. Because no compressed gas is used to deliver aerosolized medication, ventilator settings and monitored patient data parameters are not affected by the nebulizer. A baffle in the tee deflects the larger aerosol particles back down to the medication cup, where they can be re-aerosolized into smaller therapeutic-sized particles. The nebulizer is controlled by a timer system that receives its 24 V DC power from a wall power module. Nebulization time is adjustable using a separate spring-wound mechanical timer that can be set from 10 to 60 minutes. The nebulizer LED is green when the nebulizer is functioning normally. Because operating the nebulizer without buffer water can overheat the crystal, the nebulizer includes protective circuitry that turns off power to the crystal when no buffer water is present. Interruptions to ac power cause the nebulizer to enter an off-line safe mode. The LED on the nebulizer turns red when power to the nebulizer is on, but protective circuitry has temporarily turned off nebulization due to overheating or power interruption.

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Introduction

1.3 Controls and signals •

LED: When green, normal nebulization is in progress. When red, nebulizer is attached to a functioning power source, but protective circuitry has temporarily turned off nebulization.

•

Timer: The timer sets continuous nebulization time 10 to 60 minutes. The timer can be adjusted during nebulization.

1.4 Symbols and equipment labels Table 1-1 summarizes the symbols and labels that appear on the EasyNeb nebulizer and its accessories. Table 1-1: EasyNeb nebulizer symbols and labels Indicates the degree of protection provided by nebulizer enclosure (drip-proof).

IPX1 7-00403

Refer to operator’s manual. 8-00400

Type B equipment per IEC 601-1. Medical Electrical Equipment; Part 1: General Requirements for Safety. 8-00445

CSA certified with National Recognized Test Laboratory approval for Canada and the United States. 8-00417

G-yyyy03xxxx

Serial number, where yyyy is the year of manufacture. Maximum and minimum fill levels for buffer water indicated by black lines on nebulizer vial.

MAX MIN 7-00404

_____________

1-2

Maximum fill level of medication cup indicated by a line molded in the cup.

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Introduction Table 1-1: EasyNeb nebulizer symbols and labels (continued) Part number 7-00400

Lot code 7-00401

SN

Serial Number

Single patient use only

7-00402

CE marking, indicating compliance with the Medical Device Directive, 93/42/EEC.

012 3

C

RU US

Underwriters Laboratory recognized component for North America (United States and Canada) (power supply only)

For indoor use only

Timer

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Introduction Medication cup label

Timer system label

Nebulizer label

061846

Timer dial label

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Assembly and installation

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This section tells you how to install the EasyNeb timer system, assemble the nebulizer, and install the nebulizer into the ventilator breathing circuit. Warning • To prevent buffer water from entering the ventilator breathing circuit, ensure the integrity of the seal inside the tee when reassembling the nebulizer. • Medication cups are for single patient use only and are shipped ready to use. Check package seals, and do not use parts whose packaging seal is damaged. • To ensure proper nebulization and medication particle size, turn off heated humidifiers during nebulization. Do not operate the nebulizer without medication in the medication cup. • To avoid the possibility of leaks due to an improper fit between the nebulizer and unauthorized components, use the EasyNeb only with the parts recommended in these instructions. • Position all hoses and wires so they do not interfere with equipment operation or present a hazard to those working nearby.

NOTE: • Run short self test (SST) on the 840 Ventilator each time you attach or remove the EasyNeb to check for leaks and changes in circuit resistance and compliance. • Prior to each use, check the condition of the medication cup for visible signs of damage as defective cups can affect nebulizer output rates. • Before each patient use, clean nebulizer components as described in these instructions. • To minimize mineral buildup, use only distilled or sterile buffer water.

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Assembly and installation

2.1 Installing the timer system The timer system includes a power supply, timer, and mounting bracket. Figure 2-1 shows how to attach the timer system to a ventilator. Ensure that timer is off (0) before connecting to power. Install into support arm socket (either side of ventilator)

To ac (wall) power

Mounting bracket swivels for convenient installation

To power supply

8-01107

Figure 2-1. Attaching timer system to support arm socket

2-2

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Assembly and installation

2.2 Assembling the nebulizer 1. At each patient use, add buffer water to between the maximum and minimum fill lines (Figure 2-2).

Fill buffer water to between MIN and MAX lines at each patient use

Buffer water should contact tip of medication cup

7-00012

Figure 2-2. Adding buffer water 2. Remove a disposable medication cup from its packaging and place it in the buffer vial. The buffer water should cover the tip of the medication cup. 3. Add up to 10 mL of medication into the medication cup. 4. Install the tee onto the nebulizer and turn it clockwise one full turn to secure the tee to the nebulizer (Figure 2-3). 5. Install the silicone coupling and 22-mm adapter to the tee port without the arrow.

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Assembly and installation

Nebulizer tee

Arrow shows direction of flow to patient

Silicone coupling

22-mm adapter

Medication cup

Nebulizer

8-01103

Figure 2-3. Assembling nebulizer components Warning • To ensure that medication reaches the patient, do not install a heat-moisture exchanger (HME) or filter between the nebulizer and the patient. • To ensure proper nebulization and prevent medication from spilling into the ventilator breathing circuit, mount the nebulizer to maintain a vertical position (maximum tilt 15° from vertical). 6. Set the nebulizer into the holder and connect to timer system (Figure 2-4). Position the arm and bracket so that the nebulizer LED is visible and proper operation can be verified.

2-4

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Assembly and installation

Install into support arm socket (either side of ventilator)

Mounting bracket swivels for convenient installation

To patient wye

Nebulizer

Holder Connection to timer system From ventilator 8-01106

Figure 2-4. Placing the nebulizer into the holder

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Assembly and installation

2.3 Assembling the nebulizer to the breathing circuit Install the nebulizer into the inspiratory limb (Figure 2-5), downstream of any humidification system. Align arrow with direction of flow to patient Patient wye

Inspiratory limb (standard length)

LED visible on other side of holder

Silicone coupling (suspend from tube hanger to support inspiratory limb)

22-mm adapter

From ventilator and humidifier (if any)

Connection to timer system 8-01104

Figure 2-5. Installing the nebulizer into the ventilator breathing circuit

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Operation

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This section tells you how to set nebulization time (up to 60 minutes), perform a functional test for correct nebulization, and restart the nebulizer if its protective circuitry has turned it off. Warning • To ensure that the patient receives the specified amount of medication and avoid spraying medication, do not disconnect the nebulizer tee or remove the nebulizer from the ventilator breathing circuit during operation. • To avoid the risk of injury, do not allow the nebulizer to touch the patient during operation. • Follow accepted precautions and institution protocol to avoid cross-contamination. • Always carefully monitor the airway pressure during nebulization: increased airway pressure can be caused by an occluded exhalation filter. • Do not touch the medication cup or buffer water during operation.

3.1 Setting nebulization time To set nebulization time, turn timer dial past 10, then turn to select the nebulization time up to 60 minutes. The LED lights green to indicate normal operation.

3.2 Functional test Follow these steps to verify correct nebulizer operation: 1. Assemble the nebulizer (including buffer water) and connect to the timer system connected to wall (ac) power. 2. Put 5 mL of water in the medication cup. 3. Turn the timer dial past 10 to turn the nebulizer on, and verify that the nebulizer produces mist continuously and that its LED is green. 066218B (01/03)

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Operation 4. Turn the timer dial to the OFF position to turn nebulizer power off, and verify that the LED turns from green to off. 5. Discard the medication cup and empty the buffer water.

3.3 Restarting the nebulizer If the nebulizer overheats (due to a low buffer water level) or power is interrupted, the nebulizer LED turns red to indicate that power to the nebulizer is on (when the timer is selected), but that protective circuitry has temporarily turned off nebulization. Follow these steps to restart normal operation: 1. Verify that buffer water level is between the MIN and MAX lines. If not, turn off power to the nebulizer, refill buffer water, then wait two minutes to restart. 2. If a power interruption has occurred, turn the timer knob to 0 and wait for two minutes. 3. Turn the timer knob past 10, then to the selected nebulization time, verifying that the LED is green.

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