Achieva User Manual Rev D

Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Achieva® and Puritan Bennett® are registered trademarks of Nellcor Puritan Bennett Incorporated. © 2007 Nellcor Puritan Bennett Corporation. All rights reserved. For further information, contact your Puritan Bennett representative, or contact Nellcor Puritan Bennett directly by calling 1-800-635-5267.

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CONTENTS 1 Safety Information

1-1

1.1 Definitions... 1-1 1.2 Warnings and Cautions ... 1-1

2 Overview

2-1 2.1 Intended Use ... 2-1 2.2 Role of Your Clinician ... 2-1 2.3 How the Ventilator Works... 2-1 2.3.1 Overview of Ventilation ... 2-1 2.3.2 Important Terms... 2-1 2.3.3 Modes of Ventilation ... 2-2 2.3.3.1 Assist/Control (A/C) Mode... 2-2 2.3.3.2 SIMV Mode ... 2-2 2.3.3.3 Spontaneous (SPON) Mode... 2-2

3 Description

3-1

3.1 Model Number... 3-1 3.2 Symbols ... 3-1 3.3 Front Panel ... 3-4 3.3.1 Top Panel ... 3-5 3.3.2 Door Panel ... 3-6 3.4 Rear and Side Panels... 3-9 3.5 Power Supply ... 3-9 3.5.1 AC Power ... 3-10 3.5.2 External Battery ... 3-10 3.5.3 Internal Battery ... 3-10 3.6 Patient Circuit... 3-11 3.7 Supplemental Oxygen ... 3-12 3.7.1 Oxygen Enrichment Kit... 3-12 3.7.2 90° Elbow with Oxygen Fitting ... 3-13 3.8 Humidification Devices ... 3-13

4 Set Up

4-1 4.1 Preparing the Ventilator... 4-1 4.2 Where to Place the Ventilator ... 4-2 4.2.1 Electrical Interference... 4-3 4.3 Mounting the Ventilator on a Wheelchair ... 4-3 4.4 Connecting the Patient Circuit ... 4-4 4.5 Connecting the Ventilator to an AC Power Outlet... 4-5 4.6 Using an External Battery... 4-6 4.7 Setting the Low Pressure Alarm ... 4-7 4.8 Configuring for Assist/Control Ventilation... 4-8

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Contents 5 Test

5-1 5.1 Completing the User Self Test ... 5-1 5.2 Testing the Ventilator’s Alarms ... 5-3 5.2.1 Low Pressure Test... 5-3 5.2.2 Apnoea Test ... 5-4 5.2.3 Power Failure Test ... 5-4 5.2.4 Continuing Pressure (Valley) Test ... 5-5 5.2.5 High Pressure Test... 5-5 5.3 Testing the Battery... 5-6 5.4 Monthly Safety Check ... 5-6

6 Operation

6-1 6.1 Turning on the Ventilator... 6-1 6.2 Displaying Settings... 6-1 6.3 Setting Parameters ... 6-1 6.4 Starting Ventilation ... 6-2 6.5 Stopping Ventilation ... 6-2

7 Alarms and Alerts

7-1

7.1 Alarm/Alert Conditions... 7-1 7.2 Resetting Alarms ... 7-4 7.3 Alarm Latching... 7-4 7.4 Pre-Silencing Audible Alarms ... 7-5

8 Cleaning and Maintenance

8-1

8.1 Cleaning the Ventilator ... 8-1 8.2 Cleaning the Accessories ... 8-1 8.3 Recharging the Internal Battery... 8-2 8.4 Cycling Internal and External Batteries ... 8-2 8.4.1 External Battery... 8-2 8.4.2 Internal Battery ... 8-2 8.5 Home Maintenance ... 8-2 8.5.1 Replacing the Air Inlet Filter... 8-2 8.5.2 Changing the Ventilator’s Fuses ... 8-3 8.6 Preventive Maintenance ... 8-5

9 Technical Reference

9-1

9.1 Introduction... 9-1 9.2 Ventilator Specifications ... 9-1 9.3 Alarm Conditions ... 9-6 9.4 Troubleshooting... 9-14

10 Warranty Information

10-1

10.1 Limited Warranty ... 10-1

Index

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Index-1

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FIGURES Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 3-8. Figure 4-1. Figure 4-2. Figure 4-3. Figure 5-1. Figure 8-1. Figure 8-2. Figure 8-3.

Front Panel... 3-4 Top Panel... 3-5 Door Panel General Controls... 3-7 Door Panel Setting Controls and Display... 3-8 Rear and Side Panels... 3-9 Patient Circuit... 3-11 Connecting the Oxygen Supply... 3-12 Achieva Ventilator Connected to a Humidifier... 3-14 Ventilator and Battery Placement on Wheelchair... 4-4 Connecting the Power Cord to the Ventilator... 4-5 Connecting the Power Cord to an AC Outlet... 4-6 Blocking the Exhalation Manifold... 5-2 Air Inlet Filter Assembly... 8-3 Removing the Fuse Holder... 8-4 Fuse Assembly... 8-4

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TABLES Table 3-1: Table 5-2: Table 7-1:

Symbols... 3-1 User Self Test Results... 5-2 Alarm and Alert Conditions... 7-2

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SECTION C H A PT E R

Safety Information

1.1

1

1

Definitions This manual uses three indicators to highlight information of particular importance. They are: Warning Indicates a condition that can endanger the patient or the ventilator operator.

Caution Indicates a condition that can damage the equipment.

NOTE:

Indicates points of particular emphasis that make operation of the ventilator more efficient or convenient.

1.2

Warnings and Cautions This section lists general warnings and cautions for your safety and that of the patient. Warning Warnings

• Read all of this manual before using the ventilator. • Anything that damages the ventilator may cause danger to the patient. • Do not use your ventilator until you have been properly trained by your clinician and have read and understand this manual. • Make sure you can hear the ventilator’s alarm from other areas of the house, and when you are using appliances such as a vacuum cleaner, dishwasher, clothes dryer, television, or radio. • Do not use the ventilator if you suspect it may not be working properly. Contact your clinician to have the ventilator tested or replaced. • If the patient’s condition warrants the use of an independent secondary alarm or a backup means of ventilation, the clinician should prescribe it. • Wash your hands thoroughly before and after handling patient connectors and other accessories. • Always check the ventilator’s breath delivery settings before using the ventilator with a patient. When adjusting settings, special care should be taken to ensure that the new settings are correct. The use of incorrect settings during ventilation can endanger the patient.

Achieva Ventilator User’s Manual

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1

Safety Information Warning • To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (such as flammable anesthetics and/or heaters) away from the Achieva ventilator system and oxygen hoses. • Do not use hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. • In case of a burning smell, immediately disconnect the ventilator from the oxygen supply, AC power, and backup power source. • All alarms indicate a potential risk to patient safety. When an alarm sounds, provide immediate attention, care, and support to the patient as dictated by the situation. • Any device is subject to unpredictable failures. To ensure patient safety, an appropriately trained caregiver should monitor ventilation. • If the patient’s condition warrants the use of an independent secondary alarm, remote alarm, or another external monitoring device, the physician should prescribe it. The physician should also determine if the patient requires an alternate means of ventilation. • Certain types of ventilators, including the Achieva Series, have a Low Inspiratory Pressure Alarm. The purpose of this alarm is to alert the clinician or caregiver when the pre-set alarm parameters are violated. As set forth in the Achieva Series Clinician’s and User’s Manuals, a number of environmental factors and circuit accessories/components can affect the pressure in the breathing circuit. These factors may prevent circuit pressure from violating the low-pressure parameters, even in the event of a circuit being disconnected from the patient. Therefore, it is important for the clinician to consider and monitor these environmental factors when establishing pressure alarm parameters. Depending on the specific clinical situation (such as when the risk of disconnect is perceived as high and the patient is ventilator-dependent), a secondary means of monitoring ventilation, such as pulse oximetry, should be considered.

Caution Cautions

• Do not attempt to make any repairs or otherwise service the ventilator. Contact an authorized service representative for any service needs. • Do not use or store this ventilator in the presence of strong electromagnetic fields, such as an MRI environment.

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Achieva Ventilator User’s Manual

SECTION C H A PT E R

Overview

2.1

2

2

Intended Use This device is intended to provide ventilatory support for pediatric and adult patients who require positive pressure mechanical ventilation. Patients should weight no less than 11 lbs (5 kg).This device is for use in home, institutional, and portable settings. This device is contraindicated for use with anesthetic gases. This device is intended to be used on the order, and under the supervision, of a physician.

2.2

Role of Your Clinician In this manual, the term clinician means the trained health-care professional who is helping you use the Achieva ventilator in your home. This may be a doctor or nurse who is treating your patient, or some other trained health-care professional. Your clinician will: • Order a ventilator for use in your home • Train you to use the ventilator • Help you to set up the ventilator • Select appropriate accessories to use with your ventilator • Show you how to respond to alarms • Answer your questions about using the ventilator • Follow up with you on a regular basis to make sure the ventilator is meeting your needs

2.3

How the Ventilator Works 2.3.1 Overview of Ventilation A ventilator - like the Achieva ventilator you are about to use - is a device that is designed to assist the patient by moving air into their lungs and providing adequate ventilation.

2.3.2 Important Terms You should be aware of the following terms that will appear frequently throughout this manual. Mode: The manner or method of ventilatory support provided by the ventilator. Volume: The amount of air delivered to the patient with each breath. Pressure: A measure of the pressure required to “push” air into the patient’s lungs. Respiratory Rate: The number of breaths per minute.

Achieva Ventilator User’s Manual

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2

Overview 2.3.3 Modes of Ventilation The following is a general description of the various modes of ventilation available with the Achieva ventilator. It is up to your clinician to determine which modes are appropriate for your patient. 2.3.3.1 Assist/Control (A/C) Mode In Assist/Control mode, machine-initiated breaths are delivered at a clinician-set volume or pressure, inspiratory time, and rate. If the patient triggers a spontaneous breath between machine breaths, the ventilator will deliver a breath based on the volume or pressure settings. Whether initiated by the patient or the ventilator, all breaths are delivered at the same pre-set volume or pressure. 2.3.3.2 SIMV Mode In SIMV (Synchronized Intermittent Mandatory Ventilation) Mode, machine-initiated breaths are delivered at a clinician-set volume, inspiratory time and rate. These mandatory breaths are synchronized with patient effort. If the patient triggers a spontaneous breath between machine breaths, the ventilator will deliver a spontaneous breath, which can be pressure-supported. Spontaneous breaths in SIMV do not have a pre-set volume or pressure. 2.3.3.3 Spontaneous (SPON) Mode In Spontaneous mode, breaths are delivered with a volume, pressure and rate that are determined by the patient. Spontaneous mode is most frequently used with either CPAP (Continuous Positive Airway Pressure) or a combination of PS (Pressure Support) +CPAP. 2.3.3.3.1 CPAP

In CPAP, the ventilator maintains a constant level of pressure in the patient’s airway. This can help to improve oxygenation, or the level of oxygen in the patient’s blood. If your clinician has prescribed CPAP, you should talk to him or her for a further explanation of how CPAP works. 2.3.3.3.2 PS+CPAP

Like CPAP, PS+CPAP maintains a constant level of pressure in the patient’s airway. In addition, the ventilator applies a clinician-set pressure to each of the patient’s breaths. This has the same benefits as CPAP, with the additional benefit of assisting the patient in moving air into the lungs.

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Achieva Ventilator User’s Manual

SECTION C H A PT E R

Description

3.1

3

3

Model Number The Achieva’s model number is printed on the front door panel. There are certain features described in this manual that only pertain to certain models.

3.2

Symbols Table 3-1 lists the symbols that are used on the Achieva system. Table 3-1: Symbols Symbol

Description Regulatory CE mark: This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Type BF equipment, degree of protection against electrical shock Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only in accordance with UL2601-1 Certified by Canadian Standards Association to meet CAN/CSA C22.2 No. 601.1-M90 Caution/Warning/Safety Attention, consult accompanying manual

Keep dry

Fragile Alarm Indicators Alarm indicator

Low Pressure/Apnoea LED alarm indicator

High Pressure LED alarm indicator

Setting Error LED alarm indicator

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3

Description Table 3-1: Symbols (continued) Symbol

Description Power Switch-Over LED alarm indicator

Low Power LED alarm indicator

O2 Fail LED alarm indicator Alarm Control LED indicator Power Indicators AC (alternating current) LED power source indicator

External Battery LED power source indicator

Internal Battery LED power source indicator

Battery Charging LED indicator Electrical Alternating current

Direct current

Volts

Amperes Keys Standby mode of operation

Alarm Silence/Reset key

Test Battery key

Mode selection key

Menu/Escape function selection key

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Achieva Ventilator User’s Manual

Description

3 Table 3-1: Symbols (continued) Symbol

Description Up Arrow key

Down Arrow key

Volume parameter setting key

Inspiratory Time parameter setting key

Breath Rate parameter setting key

Pressure Support parameter setting key

Positive End Expiratory Pressure parameter setting key

Low Pressure alarm setting key

High Pressure alarm setting key

Sensitivity parameter setting key

FlO2 (oxygen) parameter setting key Start/Enter function setting key

Ventilate function setting key Displays I/E Ratio LCD

Flow LCD Labels and Connectors Drip proof

External Battery power connector

Achieva Ventilator User’s Manual

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3

Description Table 3-1: Symbols (continued) Symbol

Description Miscellaneous Indicators Assist/Spontaneous LED indicator

3.3

Front Panel Figure 3-1. Front Panel A D E B C

F G

A. Top Panel B. Liquid Crystal Display (LCD) C. Door Panel (open to reveal Display and Controls) D. Patient Pressure Meter E. Exhalation Valve Port F. Patient Air Port G. Patient Pressure Port

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Achieva Ventilator User’s Manual

Description

3 3.3.1 Top Panel Figure 3-2. Top Panel G F

A B

E

C

D

A. Alarms Indicators B. Power Indicators C. Alarm Control Indicator D. Assist/Spontaneous Indicator E. Patient Pressure Meter F. Alarm Silence/Reset Key G. Test Battery Key

A. Alarms Indicators The ventilator’s Alarms Indicators will flash when an alarm condition is detected. The indicators are turned off only when the condition is corrected, and the ALARM SILENCE/RESET key is pressed. Alarms Indicators exist for the following alarm conditions: – Low Pressure/Apnoea – High Pressure – Setting Error – Power Switch-Over – Low Power – O2 Fail (Achieva PSO2 only) These alarm conditions will be explained later in this manual. For now, be sure to familiarize yourself with the location of the Alarms Indicators. NOTE:

For the Achieva and Achieva PS models that do not have the oxygen function, the O2 FAIL alarm indicator position is present; however, the position is empty and unlabeled.

Achieva Ventilator User’s Manual

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3

Description B. Power Indicators The ventilator’s Power Indicators show which electrical source the ventilator is currently using and if the internal battery is being charged. Power Indicators exist for the following power conditions: – AC – External Battery – Internal Battery – Battery Charging These power conditions will be explained later in this manual. For now, be sure to familiarize yourself with the location of the Power Indicators.

C. Alarm Control Indicator The ALARM CONTROL indicator flashes when the audible alarm has been presilenced, but is lit continuously when the nonlatching alarm feature is active. You will learn more about presilencing alarms later in this manual.

D. Assist/Spontaneous Indicator The ASSIST/SPONTANEOUS indicator lights when the patient’s breathing effort meets or exceeds the ventilator’s sensitivity setting.

E. Patient Pressure Meter The PATIENT PRESSURE meter (Figure 3-2, item “E”) shows the level of pressure that is currently in the patient circuit.

F. Alarm Silence/Reset Key The ALARM SILENCE/RESET key silences the audible alarm during an alarm condition and can be used to pre-silence the audible alarm for a period of 60 seconds. If an alarm condition occurs while the 60-second pre-silence period is in effect or while ALARM SILENCE/RESET is active, the front panel LCD (Figure 3-1, item “B”) will display the alarm condition, but the alarm will not sound. This key can also be used to reset an alarm after the alarm condition has been corrected.

G. Test Battery Key When the TEST BATTERY key is pressed and held, the PATIENT PRESSURE meter (Figure 3-2, item “E”) shows the charge level of the battery currently in use.

3.3.2 Door Panel The display and control panel is located behind the ventilator’s front door panel (Figure 3-3). This front door panel is magnetically latched to prevent tampering and accidental resetting when closed. The following is a brief explanation of each of the controls. Further information regarding how and when you should use the controls will be provided later in this manual.

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Achieva Ventilator User’s Manual

Description

3 General Controls Figure 3-3. Door Panel General Controls A

B

C

E

D A. Standby key

D. Up and Down Arrow keys

B. Ventilate key

E. Start/Enter key

C. Menu/Escape key

A. Standby When pressed and held for three (3) seconds, the STANDBY key causes the ventilator to stop delivering air.

B. Ventilate Pressing the VENTILATE key causes the ventilator to begin delivering air.

C. Menu/Escape Pressing the MENU/ESC key activates the menu options on the ventilator’s display.

D. Up Arrow and Down Arrow The UP ARROW and DOWN ARROW keys are typically used to move between values displayed in the ventilator’s LCD window (Figure 3-4, item “R”). While a ventilator setting is flashing, pressing the up and down arrow keys will increase or decrease the flashing setting’s value. While the ventilator’s menu options are active, pressing the up and down arrow keys allows you to move between menu levels. If none of the ventilator’s settings are flashing, and the menu

Achieva Ventilator User’s Manual

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3

Description options are not active, pressing the up or down arrow keys will cause the last alarm message to be displayed in the LCD window.

E. Start/Enter If the ventilator is in Standby, pressing the START/ENTER key (Figure 3-3, item “E”) will activate the display in the LCD window (Figure 3-4, item “R”). START/ENTER is also used to accept a flashing setting value.

Setting the Controls and Display You can select a setting by pressing the corresponding setting control key. Selecting a setting will cause the current setting value to flash in the LCD window (Figure 3-4, item “R”), allowing for adjustment of the setting value. Each setting value displayed in the LCD window corresponds with the control nearest it (above or below.) Values displayed in the top row correspond to the row of controls located directly above the LCD window. Values in the bottom row correspond to the controls directly below the window. Figure 3-4. Door Panel Setting Controls and Display F

G

H

I J R

K NOTE:

L

M

N

O

P

Q

The I:E Ratio and Flow settings do not have keys. These controls are labeled for display purposes only. Refer to Figure 3-4.

F. Mode key

L. Pressure key

G. Volume key

M. PEEP key

H. Inspiratory Time key

N. Low Pressure key

I.

Flow LCD

O. High Pressure key

J.

Sensitivity key

P. I:E Ratio LCD

K. Breath Rate key

Q. FiO2 key (Achieva PSO2 only) R. LCD Window

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Achieva Ventilator User’s Manual