Covidien Puritan BennettTM 540 Ventilator Manual
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Clinician’s Manual
Puritan Bennett
TM
540 Ventilator
To obtain information about a warranty, if any, contact Covidien Technical Services at
1.800.635.5267 or your local representative.
Purchase of this instrument confers no express or implied license under any Covidien patent to use the instrument with any ventilator that is not manufactured or licensed by Covidien.
Copyright information
Copyright 2011 Covidien. All rights reserved.
COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. All other brands are trademarks of a Covidien company.
The information contained in this manual is the sole property of Covidien and may not be duplicated without permission. This manual may be revised or replaced by Covidien at any time and without notice.
You should ensure that you have the most current applicable version of this manual; if in doubt, contact
Covidien’s Technical Support department or visit the Puritan Bennett™ product manual web page at: http://www.puritanbennett.com/serv/manuals.aspx
While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment.
The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator, and its use, is as stated in the limited warranty provided.
Nothing in this manual shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.
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Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
1
2
3
4
5
Safety Information 1–1
Ventilator Overview 2–1
Operating Parameters 3–1
Volume A/C Mode Parameters and Setting Ranges . . . . . . . . . . . . . . . . . . . . . . . . . 3–11
Volume SIMV Mode Parameters and Setting Ranges . . . . . . . . . . . . . . . . . . . . . . . . 3–20
For Various Oxygen and Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 3–26
Monitored Parameters 4–1
Alarms and Troubleshooting 5–1
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A iii
Contents
6
7
8
Installation and Assembly 6–1
Connecting the Oxygen Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6–14
Operating Procedures 7–1
Changing the SETUP Screen Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–3
Changing Modes While Ventilation is on Standby . . . . . . . . . . . . . . . . . . . . 7–11
Changing Modes During Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–12
Setting a Ventilation Parameter Linked to Other Ventilation Parameters . . . 7–15
Setting a Ventilation Parameter Linked to Alarm Thresholds . . . . . . . . . . . . 7–15
Internal Battery 8–1
iv 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Contents
A
B
9
Cleaning 9–1
10 Routine Maintenance 10–1
C
Patient/Caregiver Checklist A–1
Specifications B–1
Theory of Operation C–1
D
E
Modes and Breath Types D–1
Volume Breaths in Assist/Control Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . D–2
Pressure Control in Assist/Control Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . D–3
Volume Breaths in V SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D–4
Pressure Supported Breaths in SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . D–6
Operational Verification Checklist E–1
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A v
Contents
F
G
H
Alarms Tests F–1
Unpacking and Preparation
Parts and Accessories
I
Index
Glossary
G–1
H–1
I–1
Index–1
vi 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
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Figures
Close-up of Exhalation Valve Tube and Proximal Pressure Tube . . . . . . . . . . . . . . . . . . 6–9
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A vii
Figures
viii 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
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Tables
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A ix
Tables
Electromagnetic Immunity – Conducted and Radiated RF. . . . . . . . . . . . . . . . . . . . . . B–15
x 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
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Preface
Purpose of This Manual
This manual contains important information regarding the safe operation of your
Puritan Bennett™ 540 Ventilator. Your ventilator is an electrical device that can provide years of useful service with the proper care, as described in this manual.
Ensure that you read and understand the instructions contained in this manual before operating the ventilator.
Warning
Before operating the ventilator, read, understand, and strictly follow the information
contained in Chapter 1, “Safety Information”
.
Qualification of Personnel
Installation and maintenance of the device must be made by authorized and trained personnel.
In particular, training for the handling of products sensitive to electrostatic discharges must include the use of Electrostatic Discharge (ESD) protection devices and knowledge of the following symbol’s meaning: , as well as using original spare parts and respecting quality assurance and traceability rules approved by Covidien.
Warranty
Information regarding your product warranty is available from your sales representative or
Covidien.
Extended Service
The Puritan Bennett 540 Ventilator offers extended service contracts/warranties for purchase when the ventilator is purchased. Please contact your local Covidien Sales or Service
Representative for additional information.
Preface
For online technical support, visit the SolvIT SM
Center Knowledge Base by clicking the link at http://www.puritanbennett.com. Here, you will find answers to frequently asked questions about the
Puritan Bennett™ 540 Ventilator and other Covidien products 24 hours a day, 7 days a week. If you require further assistance, contact your local Covidien representative or call Covidien Technical Support at
1.800.255.6774.
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Safety Information
1.1
Definitions
This manual uses three indicators to highlight critical information: Warning, Caution, and Note.
They are defined as follows:
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.
It is essential to read, understand and follow these instructions before using the
Puritan Bennett™ 540 Ventilator.
In order to use the ventilator correctly and efficiently and to help prevent incidents, please pay particular attention to sections 1.2,
and 1.3,
as well as all warnings and cautions contained throughout this manual.
Safety Information
1.2
Warnings
General Precautions For Use
Warning
• Federal law restricts this device to sale by or on the order of a licensed physician.
• The ventilator must be used only under the responsibility and on the prescription of a doctor.
• Be aware this manual describes how to respond to ventilator alarms, but it does NOT tell you how to respond to the patient.
• While the ventilator is in use, an alternative means of ventilation should always be available in the event of a ventilator problem. This is particularly true for ventilator-dependent patients. Supplementary observation, appropriate for the patient's condition, is also recommended.
• To ensure that ventilation continues uninterrupted, ensure alternative power sources are available (AC power source, extra batteries, or an auxiliary DC car adapter). Be prepared for the possibility of power failure by having an alternative means of ventilation ready for use – particularly for ventilator-dependent patients.
• Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.
• The ventilator must not be used with flammable anesthetic substances.
• Do not start ventilation until you ensure that the device is suitably assembled, that the air inlet filter is properly installed and is not obstructed, and that there is proper clearance all around the unit. Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient circuit, including all hoses, is not damaged or obstructed.
• You must start the ventilator and allow it to complete one full breath cycle prior to connecting the patient. Do not connect the patient before this cycle completes.
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated occasionally while powered by its internal battery. Ensure that the internal battery never becomes fully discharged.
• A ventilator-dependent patient should always be monitored by trained and competent medical personnel. Ensure that the patient’s caregiver is able and prepared to take suitable action in the event the ventilator identifies an alarmed condition or experiences a problem.
• Before dispensing the ventilator to caregivers or the patient for home use, ensure the Locking Key is activated so that critical ventilator settings are not modified.
• Do not perform ventilator alarm tests while the patient is connected to the ventilator.
• Verify the functionality of the alarms conditions before connecting the patient to the ventilator.
or call your equipment supplier or Covidien.
• When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
• A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, the ventilation will resume without having to press the VENTILATION ON/OFF button.
• To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a
double-limb circuit is used – is recommended. Refer to chapter 9, “Cleaning”
.
• Handle the ventilator with care during and after use, particularly when room temperatures are high.
Some ventilator surfaces may become hot, even if safety specifications are not exceeded.
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Safety Information
General Precautions For Installation
Warning
Environment:
• Because the internal Lithium-ion battery of the Puritan Bennett™ 540 Ventilator contains more than 8g
(equivalent) lithium and has a power-rating greater than 100 Wh (watt-hour), it is categorized as
Hazardous Material (Dangerous Good), Class 9- Miscellaneous, even though the ventilator meets current safety standards.
The ventilator, because of this categorization, is subject to strict transport conditions under the
US Department of transportation (US DOT) regulations for the transport of hazardous materials (49 CFR
173.185).
As US DOT regulations cover commercial transportation only, there are two groups that can be exempted from these regulations. The first group consists of private individuals, providing that the goods are for their own personal use and measures have been taken to prevent leakage. The second group consists of persons that transport the goods because they need the product to execute their job(s). The later group is able to carry/transport certain hazardous materials, such as the Puritan Bennett 540 Ventilator and the associated Lithium-ion battery(ies), under the established Materials of Trade (MOT) provisions detailed in
49 CFR 173.6. For any other group or purpose, transport must be compliant with the applicable
Hazardous Materials/Dangerous Goods regulations specific to the origin/destination and mode of transport. Air transport of the Puritan Bennett 540 Ventilator in only allowed as carry-on baggage, which may include up to two (2) individually packaged spare Lithium-ion batteries (it is recommended that users verify specific requirements/limitations with the airline carriers as to which measures to take before the voyage).
• Even though the Puritan Bennett 540 Ventilator meets current safety standards, the internal Lithium-ion battery of this device contains more than 8g equivalent lithium and exceeds a power-rating of 100 Wh
(watt-hour) and therefore considered to be a Hazardous Material (Dangerous Good), Class 9 -
Miscellaneous when transported in commerce. As such, the Puritan Bennett 540 Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions established by the US
Department of Transportation (49 CFR 173.185) as well as other international transportation regulations.
This classification and regulatory requirements may vary depending upon the country and mode of transport. In addition, air transport of the Puritan Bennett 540 Ventilator is only allowed as carry-on baggage, which may include up to two (2) individually packaged spare Lithium-ion batteries. (it is recommended that users verify specific requirements/limitations with the airline carriers as to which measures to take before the voyage).
Table H-1, List of Consumables and Accessories
.
• The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately.
• To avoid damage to the ventilator, fluids must not be allowed to enter the device, particularly through the air inlet filter or the cooling apertures located in the side, rear, and bottom panels of the ventilator.
• To ensure correct and lasting operation of the device, ensure that the ventilator is installed and operated in the environmental conditions recommended in
Appendix B, “Specifications” .
• Do not operate the ventilator in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device.
• Ensure that the ventilator’s immediate surroundings allow for the proper operational connection of the device without folding, pinching, or damaging any of the required cables or tubes, and that the connection of the patient circuit to the patient provides for a secure, comfortable fit.
• Do not place the ventilator in a position where a child can reach it or in any position that might cause it to fall on the patient or someone else.
• To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes (main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains.
• If the ventilator has been transported or stored at a temperature that differs more than ± 36 °F (± 20 °C) from the temperature in which it will be operating, the ventilator should be allowed to stabilize in its operating environment for at least two (2) hours prior to use.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 1-3
Safety Information
Warning
Environment (Cont’d):
• If the room temperature where the device is operated is greater than 95 °F (35 °C), the flow supplied at the device outlet may exceed 106 °F (41 °C). This may lead to undesirable side effects for the patient. To avoid injury to the patient move the patient and the ventilator to a cooler location. For more information, contact Covidien.
• The default setting for altitude compensation is YES. Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations.
• 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 ventilator and oxygen hoses.
• If the ambient temperature is above 104 °F (40 °C), the battery's thermal cut-off circuit may prevent the battery from recharging fully – even if the INTERNAL BAT charging indicator indicates the battery is completely recharged.
• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary,
replace the filter before the recommended replacement period is over (see chapter 10, “Routine
). This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
• Handle the ventilator with care during and after use, particularly when room temperatures are high.
Some ventilator surfaces may become hot, even if safety specifications are not exceeded.
Electrical Power Supplies:
• Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off.
• For the AC (“mains”) power cable to be properly secured, the attachment located on the power cable must be fitted into the power cable holder incorporated in the battery access cover and located under the
AC (mains) power socket. Refer to section 6.2, “Connecting to External AC Power”
.
• The power supply to which the ventilator is connected (both AC and DC) must comply with all applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear
.
• Ensure that the ventilator’s internal battery is fully charged before connecting the ventilator to an external DC power source. Powering the ventilator using an external 12– 30 VDC power source (via the
DC power cable) does not enable charging of its internal battery.
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated occasionally while powered by its internal battery. Ensure that the internal battery never becomes fully discharged.
• When using a car auxiliary adapter (cigarette lighter) ensure the car has been started prior to plugging in the ventilator’s DC adapter.
• Even if the “INTERNAL BAT“ indicator is off, charge of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 104 °F (40 °C). This is due to the characteristics of the battery’s internal heat safety device.
• When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.
• When replacing the ventilator’s internal battery, the ventilator must be disconnected from all external power supplies and turned off.
• Batteries should be disposed of according to environmental legislation in your country and locality.
• Never expose any batteries to direct flame.
• Never touch the ventilator’s internal components, including the battery, and the patient simultaneously.
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Safety Information
Warning
Hoses and Accessories:
• The ventilator must not use, nor be connected to, any anti-static or electrically conductive hoses, tubing, or conduits. High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation.
• During invasive ventilation (when an artificial airway bypasses the patient’s upper respiratory system), the patient’s upper respiratory system cannot humidify the incoming air. For this reason, the use of a humidifier, to minimize drying of the patient’s airways and subsequent irritation and discomfort, must be used.
• If exhaled tidal volume or exhaled minute volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must be used in order to detect leaks. In this case, both the High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation.
• The patient circuit should always be positioned to avoid hindering the patient's movements, to prevent accidental disconnection, and to minimize the risk of patient strangulation.
• For pediatric use, ensure that the patient circuit type fits, and, in all respects, is suitable for use with a child. Use a pediatric circuit for patients that weigh under 53 lb. (23 kg).
See Table H-2, List of Circuits , on page H-3, for a list of recommended patient circuits.
• Resistance of the exhalation valve and accessories (water traps, filters, etc) must be as low as possible.
• Adding attachments to the ventilator breathing system can cause the pressure during exhalation at the patient connection port to increase.
• The exhalation valve must allow rapid discharge of the circuit pressure. Ensure that the exhalation valve is always clean and its evacuation aperture (exhaust port) is never obstructed.
• Users must always possess an additional breathing circuit and exhalation valve while using the
Puritan Bennett™ 540 Ventilator.
• Consult with your Customer Support representative before attempting to use a heated humidifier.
• Always position a humidification device so that it is lower than both the ventilator and the patient. Use water traps, if necessary, to limit water in the patient circuit and periodically empty these water traps.
• If a heated humidifier is used, you should always monitor the temperature of the air delivered to the patient. Air delivered from the ventilator that becomes too hot may burn the patient's airway.
• Adding accessories to the ventilator breathing circuit, such as a humidifier and water trap(s), may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory. Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration.
• The level of inspiratory resistance of the circuit and accessories (bacteria filter, humidifier, and so on) must be as low as possible. Settings – particularly the LOW PRESSURE DISCONNECT alarm, High inspired volume (High VTI), and Low inspired volume (Low VTI) settings – must be periodically adjusted according to changes in the patient circuit resistance – especially when filters are replaced.
• To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this
manual; refer to chapter 6, “Installation and Assembly”
and Appendix H, “Parts and Accessories”
. The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 3.6 feet (1.10 meters) to 6.6 feet (2.00 meters). The tubing must conform to all applicable standards and must be fitted with Ø 22 mm terminals that also conform to all applicable standards.
Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume: a corrugated tube of Ø 22 mm for adult patients, and a corrugated tube of Ø 15 mm for pediatric patients with a tidal volume lower than 200 ml.
• When using non-invasive ventilation (niv), use a non-vented nose or face mask.
• Before using the Nurse Call system, ensure that its connections are secure and it operates properly. For more information, contact Covidien.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 1-5
Safety Information
Precautions Regarding Settings
Warning
• Always verify that all settings are properly set before starting ventilation.
• Before starting ventilation, ensure that the device is properly assembled and that the air inlet, cooling vents, and alarm sound diffusion holes are not obstructed. Ensure also that the patient circuit is of the proper configuration (double or single limb), properly connected to the ventilator, and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies.
• The CPAP mode does not provide a set respiratory rate. Do not use this mode for ventilator-dependent patients.
• Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.
• Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. The audible alarm vents located at the front of the device should never be obstructed. The alarm can be paused with the Alarm Pause function by pressing the ALARM
CONTROL key twice once the alarm has been declared.
• Monitor the patient's state of health in order to ensure that the ventilator’s settings are always suited to the patient’s current physiological requirements.
• In the case of pediatric use, ensure that the adjusted tidal volume is compatible with the needs of the child.
• Ensure that the tidal volume setting in VC is compatible with the needs of the patient.
• When changing the mode during ventilation, significant transitions of pressure, flow or cycling rate might occur, depending on the difference between the modes. Before setting the new mode, first ensure that the settings between the different modes are compatible. This reduces the risk of discomfort and harm to the patient.
• Do not conduct the ventilator alarm test while the patient is connected to the ventilator. Switch the patient to an alternate means of ventilation before testing.
• The setting of the Low PIP alarm must be adjusted for the patient, but must also be set high enough to allow the LOW PRESSURE DISCONNECT alarm to trigger properly. Perform the Low Pressure Test (refer to
section F.1, “Low Pressure Test” ) to ensure the Low PIP alarm is properly set.
• If APNEA TIME is set to a value higher than 60/Control R then the APNEA alarm will not activate.
• Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
• Ensure the Insp Time setting is compatible with the physiological requirements of the patient.
• When the Inspiratory time exceeds the Expiratory time, an INVERSED I:E RATIO alarm will be activated.
Before confirming such a setting, first ensure that the setting is compatible with the physiological requirements of the patient. The Inverse I:E Ratio alarm can be silenced with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared.
• Adjustable alarms should not be systematically cancelled; instead, they should be adjusted according to the needs and condition of the patient.
• A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, the ventilation will resume without having to press the VENTILATION ON/OFF button.
1-6 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Safety Information
Maintenance Precautions
Warning
• Never use a ventilator or any components or accessories that appear to be damaged. If any signs of damage are evident, contact your equipment supplier or Covidien.
• If you cannot determine the cause of a problem with your ventilator, contact your equipment supplier. Do not use the ventilator until the problem has been corrected.
• Except for replacing the internal battery and performing the recommended maintenance described in
Chapters 8 through 10 of this manual, do not try to repair or otherwise service the ventilator yourself, or modify the ventilator, its components, or accessories. Doing so might endanger the patient, cause damage to the ventilator, and/or void your warranty. Only qualified service personnel should attempt repair of the ventilator.
• On a daily basis, ensure the proper connection and operation of the patient circuit.
• If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER. If necessary, remove the patient from the ventilator and provide an alternative means of ventilation.
• After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.
• Use all cleaning solutions and products with caution. Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator. Use only those solutions listed in
.
• Do not attempt to repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, and/or void your warranty. Only qualified service personnel should repair or service the ventilator.
• If the ventilator is damaged or its external housing is not correctly closed or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
• The exhalation block is intended for single use by a single patient. It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean
block should be changed every 3 months and cannot be reused with any other patient.
• Ensure that the exhalation block is completely dried after cleaning and prior to use.
• When an exhalation block is set up, each time it is removed, or after installing a new exhalation block on the machine, it is essential that the expiratory flow sensor be recalibrated before the exhalation block is
used. Refer to section 10.1, “Calibrating the Expiratory Flow Sensor”
).
• The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer’s recommendations. Refer to the instructions for use supplied by the manufacturer of the
patient circuit (included with the ventilator) and chapter 6, “Installation and Assembly” .
• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a
double-limb circuit is used – is recommended. Refer to chapter 9, “Cleaning”
.
• When replacing the ventilator’s internal battery, the ventilator must be disconnected from all external power supplies and turned off.
• Never touch the ventilator’s internal components, including the battery, and the patient simultaneously.
• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary,
replace the filter before the recommended replacement period is over (see chapter 10, “Routine
). This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
• For environmental protection, the ventilator and its components, whatever their respective conditions of operation, cannot be disposed of with household waste and must be submitted for suitable selective collection and possible recycling. Observe all applicable regulations when disposing of the ventilator and any of its components.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 1-7
Safety Information
Warning
Maintenance Precautions (Cont’d):
• If the device is damaged, its external housing is not correctly closed, or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
• After replacing the ventilator’s internal battery, push on the battery’s cover from the rear towards the front to take pressure off the cover mounting brackets, thereby avoiding breakage when the screws are tightened.
Precautions Regarding Oxygen
Warning
• The ventilator must not be used with flammable anesthetic substances.
• Oxygen therapy for patients with respiratory failure is a common and effective medical prescription.
However, be aware that excessive oxygen use is likely to lead to serious complications – including, but not limited to, patient injury.
• Strictly follow the instructions provided in section 6.8.2, “Connecting the Oxygen Supply”
, which include the use of a flow regulator and special coupler.
• To avoid injury to the patient and/or possible damage to the ventilator: before using the ventilator, use a flow meter (flow regulator) to regulate the oxygen supply to specifications before connecting the ventilator to the oxygen supply.
• The Puritan Bennett™ 540 Ventilator does not include an oxygen analyzer. Always measure the delivered oxygen with a calibrated oxygen analyzer that features a high and low concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
• Ensure that the oxygen supply pressure to the machine never exceeds 7.25 psi (49.99 kPa) or a flow of
15 lpm. Refer to Table B-8 on page B-3 for volume and sensitivity tolerances.
• In the event of an oxygen leak, shut down the supply of oxygen at its source. In addition, remove and/or keep any incandescent source away from the device, which may be enriched with oxygen. Air the affected room to bring the oxygen level down to normal.
• The hose connecting the ventilator to the oxygen source must be designed exclusively for use with medical-grade oxygen. Under no circumstances should the oxygen hose be modified by the user. In addition, the hose must be installed without the use of lubricants.
• Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical-grade oxygen.
• The coupler must not remain connected to the oxygen connector unless it also connected to a leak-proof, external oxygen gas source. When an oxygen supply is not being used with the ventilator, disconnect the oxygen source completely from the ventilator.
• To prevent any interference with the internal sensors of the ventilator, do not install a ventilator humidifier upstream of the ventilator.
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Safety Information
1.3
Cautions
General Precautions For Use
Caution
• To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator, only qualified personnel should attempt to service the Puritan Bennett™ 540 Portable Ventilator.
General Precautions For Installation
Caution
Environment:
• Avoid using the ventilator, if possible, in dusty environments. Dusty environments may require more vigilant monitoring, cleaning, and/or replacement of air intake and other filters.
Electrical Power Supplies:
• Before using the ventilator’s internal battery, ensure that the battery is fully charged and that the charge holds.
• Do not store the internal battery, either installed within or removed from the ventilator, for more than two (2) years.
• To connect the ventilator to an external power source, first ensure the ventilator’s I/O switch is off ( O ).
Then, connect the desired power cable to the ventilator. Finally, connect the power cable to the external power source.
• To disconnect the ventilator from an external power source, first power-down the ventilator. Then, disconnect the power cable from the external power source and, finally, the ventilator.
• Do not leave power cables lying on the ground where they may pose a hazard.
• Ensure that the AC power cable is in perfect condition and not compressed.
• To connect the ventilator to a Nurse Call device, contact Covidien to check the ventilator's compatibility with the
Nurse Call device and order a suitable connection cable. Do not use Nurse Call devices that operate based on the closure of an electrical circuit, because the devices often do not take into account possible cable disconnection or a total loss of power. Ensure that the Nurse Call device is always connected to the ventilator.
Caution
Hoses and Accessories:
• Before opening the packaging for the Patient Circuit, ensure that no damage is evident to the packaging or its contents. If evidence of damage exists, contact your supplier.
Maintenance Precautions
Caution
• Before cleaning the ventilator, first disconnect the ventilator and the circuit.
• Never use a liquid cleaner inside the patient circuit, or on any component of a gas pathway. Clean the patient circuit only as specified by the manufacturer's instructions.
• If the ventilator is used indoors, the condition of the air inlet filter should be checked monthly. If the ventilator is used outdoors or in a dusty environment, the filter should be checked weekly and replaced as necessary.
• The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.
• Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause serious damage to the ventilator.
• The SET UP menu is only accessible if ventilation is stopped and the ventilator is powered on while the
ALARM CONTROL key
is pressed. Refer to section 7.2, “Setup Screen Parameters.”
• Except for changing the battery (as required by qualified technicians or the Clinician), do not attempt to open the ventilator’s enclosure. Doing so might result in damage to the device and/or may void your warranty.
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Safety Information
Precautions Regarding Oxygen
Caution
• The oxygen supply hose ages even when it is not in use and should be replaced periodically. The expiration date may be located on the back of the hose end-piece.
• The oxygen supply must be regulated using a flow meter connected to the source gas outlet.
• The oxygen supply must be shut off when ventilation is interrupted. Before disconnecting the oxygen hose, allow the ventilator to continue for a few cycles without oxygen to flush the patient circuit of excess oxygen.
Precautions Regarding Electromagnetic Interference
Caution
• The Puritan Bennett™ 540 requires special precautions for electromagnetic compatibility and should be installed and
started according to the recommendations found in Appendix B, “Specifications.”
In particular, the use of nearby mobile and portable communications equipment using radio frequencies, such as mobile telephones or other systems exceeding the levels set in the IEC 60601-1-2 standard, may affect its operation.
Refer to section B.9, “Manufacturer’s Declaration”
.
• The use of any accessory other than those specified, with the exception of the power supplies or cables sold by
Covidien, may lead to an increase in electromagnetic emissions or a decrease in the equipment protection against electromagnetic emissions. If the ventilator is used adjacent to such accessories or stacked with such devices, the ventilator’s performance should be monitored to verify normal operation.
1.4
Symbols and Markings
Table 1-1. Ventilator Symbols
Symbols Descriptions
It is essential to read, understand, and follow these instructions before using the Puritan Bennett 540 Ventilator
(ISO 7000-0434A).
This symbol appears on the ventilator’s back panel, and internal battery; see
, item 11.
Type BF applied part (IEC 60417-5333).
A regulatory standard classification for protection against electrical shock for the part of the device that contacts the patient.
This symbol appears on the ventilator’s back panel; see Table 1-2
, item 6.
Direct current, DC (IEC 60417-5031).
This symbol appears on the ventilator’s back panel; see Figure 1-4
, item 10. Figure 6-5 on page 6-5.
Alternating current, AC (IEC 60417-5032).
This symbol appears on the ventilator’s back panel and keyboard; see Figure 1-4
, item 9, and
Figure 2-3 on page 2-6, item 10.
Internal Battery.
This symbol appears on the ventilator’s keyboard; see
Figure 2-3 on page 2-6, item 10.
Insulation class II equipment (IEC 60417-5172).
A regulatory standard classification for protection against electric shock. Class II equipment relies on double insulation rather than protective earthing.
This symbol appears on the ventilator’s back panel; see Table 1-2
, item 6.
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Safety Information
Table 1-1. Ventilator Symbols (Continued)
Symbols
IP31
Descriptions
Index of Protection rating for the ventilator’s enclosure, defined in IEC 60529 (BSEN60529:1991).
The first digit, 3, indicates protection against the intrusion of small foreign bodies (including fingers, tools, wires, etc. with a diameter greater than 2.5 mm) into the ventilator. The second digit, 1, indicates protection against water dripping or falling vertically, as well as an environment featuring water vapor condensation and/or light rain.
This rating appears on the ventilator’s back panel; see Table 1-2 , item 6.
CSA – Canadian Standards Association.
This symbol appears on the ventilator’s back panel; see
, item 6.
This key is used to: move the LCD display’s cursor upwards, line-by-line; increase the value of displayed and selected parameter settings; restart (“unfreeze”) waveforms tracing.
This symbol appears on the ventilator’s front panel DOWN/FREEZE key; see
Figure 2-3 on page 2-6, item 5.
This key is used to: move the LCD display’s cursor downwards, line-by-line; decrease the value of displayed and selected parameter settings; stop (“freeze”) waveforms tracing.
This symbol appears on the ventilator’s front panel ENTER key; see
Figure 2-3 on page 2-6, item 4.
This key is used to confirm command actions.
This symbol appears on the ventilator’s front panel ALARM CONTROL
key; see Figure 2-3 on page 2-6, item 3.
(See my notes, to the left and below, in red).
This key is used to: cancel the audible portion of alarms for 60 seconds at a time; cancel an alarm.
For more information, refer to section 5, “Alarms and Troubleshooting.”
This symbol appears on the ventilator’s front panel MENU key; see
Figure 2-3 on page 2-6, item 7.
This key is used to access the ventilator’s menus via the ventilator’s front panel LCD display.
This symbol (IEC 60417– 5009) appears on the ventilator’s front panel VENTILATION ON/OFF button; see
Figure 2-3 on page 2-6, item 8.
This key is used to Start and Stop ventilation.
Air outlet towards patient.
This symbol appears on the front right of the ventilator, adjacent to the TO PATIENT port; see
, item 2, and Figure 6-9 on page 6-9.
Air return from patient (double-limb option).
This symbol appears on the front-left of the ventilator, adjacent to the From Patient port ; see
Patient proximal pressure port.
This symbol appears on the front right of the ventilator, adjacent to the From Patient port; see
, item 4, and Figure 6-9 on page 6-9.
Exhalation valve pilot port.
This symbol appears on the front right of the ventilator, adjacent to the TO PATIENT port indicating the connection of the tubing between the patient circuit exhalation valve; see
, item 4, and Figure 6-9 on page 6-9.
Oxygen inlet.
This marking appears on the back panel of the ventilator, adjacent to the oxygen inlet port; see
, item 3, and Figure 6-14 on page 6-15.
Nurse Call connector.
This symbol appears on the back panel of the ventilator, adjacent to the nurse call connector; see
, item 3, and Figure 6-18 on page 6-19.
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Safety Information
Table 1-1.
Ventilator Symbols (Continued)
Symbols
O
I
Descriptions
Switch in “Off” position (IEC 60417-5008).
This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator
to indicate the switch’s “Off” position. See Figure 2-2 on page 2-5, item 2.
Switch in “On” position (IEC 60417-5007).
This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator
to indicate the switch’s “On” position. See Figure 2-2 on page 2-5, item 2.
Software Lock Enabled.
This symbol appears on the upper-left of the ventilator’s LCD display when the keyboard Locking Key is enabled;
see section 7.7, “Locking the Control Panel”
.
Internal Battery.
This symbol appears on the top-center of ventilator’s LCD display to indicate that the ventilator is being powered
by its internal battery. See Figure 2-4
on page 2-7, item 1 and refer to chapter 8, “Internal Battery”
, for more information.
Pressure rise times (inspiratory phase) parameter.
These symbols appear on the ventilation mode menu screens. For more information, refer to chapter 3,
. In pressure ventilation modes, you can select one of four rise times with setting 1 representing the fastest rise time and setting 4 representing the slowest.
Flow shape (“flow distribution shape”, inspiratory phase) parameter.
These symbols appear on the ventilation mode menu screens; selectable for Vol A/C mode only. For more
Square (SQ) or Descending (D) flow patterns.
Selected line (filled square).
Figure 7-3, Selecting the Preferences Menu , on page 7-7.
Non-selected line (empty square).
When making menu choices, this graphic indicates a line on which the cursor is currently not positioned.
Locked parameter line.
When making menu choices, this graphic indicates a line that cannot be selected (the Locking Key is enabled).
Active parameter line.
When making menu choices, this graphic indicates that the current parameter is selected and can be changed.
See chapter 7, “Operating Procedures”
.
Inspiratory Effort Detected.
This symbol appears in the front panel display’s Status window when the patient triggers a breath.
Parameter adjustment bar.
This graphic shows the current setting for parameters such as display contrast and alarm volume in the
Preferences menu. Refer to section 7.3, “Preferences Menu Parameters” .
WEEE (Waste Electrical and Electronic Equipment).
This symbol means that this product must not be disposed of with household waste. Observe local ordinances for proper disposal. Refer to
, item 6.
Year of Manufacture.
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Safety Information
Table 1-1. Ventilator Symbols (Continued)
Symbols Descriptions
Manufacturer.
Audio Paused.
5.4, “Silencing the Audible Portion of Alarms” .
Alarm Paused (reset/cancelled).
This symbol means one or more alarms have been paused, or reset/cancelled. For more information, refer to
section 5.5, “Pausing/Resetting Alarms”
.
Single patient use only (ISO 7000-1051).
This symbol means that the labeled device is for use by a single patient only. Refer to
, item 5.
Freeze Waveforms.
This symbol means the tracing of patient pressure and flow waveforms is currently paused or “frozen.”
For more information, refer to section 4.3, “Waveform Display”
.
Follow instructions for use (ISO 7000-1641).
This symbol directs the user to observe and adhere to the instructions contained in the product’s user manuals.
USB port.
This symbol indicates a communications port for interfacing with a USB connector.
, item 10. Not currently used.
PC connector.
This symbol indicates a port that can be used by authorized Covidien service personnel for software maintenance. See
Atmospheric pressure limitation.
Humidity limitations.
Temperature limitations.
Fragile.
Keep dry.
Keep away from direct sunlight.
This side up.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 1-13
Safety Information
1.5
Labels / Identification and Instruction Information
Various labels or specific markings are affixed to the ventilator that describe precautions to be taken for the
figures on the following pages for illustrations of these labels and markings and their locations on the
ventilator. Use the item numbers in the following tables to locate the labels in Figure 1-1 through
.
Table 1-2. Ventilator Labels and Markings
1.
Alarms Test Label ( Figure 1-1
,
2. Patient Gas Inlet Label
,
3. Oxygen Inlet Marking and Label
(
4. Exhalation Valve and Patient
Pressure Connection Label
,
,
)
5. Exhalation Limb
Connection of Patient Circuit –
Single Use Exhalation Block
Label
,
)
6.
Air Inlet Label
(
1-14 10071604 Rev. A
7.
Exhaled Gas Outlet Label
,
)
Puritan Bennett™ 540 Ventilator Clinician’s Manual
Safety Information
Table 1-2. Ventilator Labels and Markings (Continued)
Location of AC
Power Cable
Connector
Location of DC
Power Cable
Connector
8. Identification Label
(
)
9.
AC Power (Mains)
Cable Connector Marking
(
10. External DC Power
Cable Connector Marking
(
)
11. Direction of Installation of
Internal Battery Label
(
)
12.
Warning - Caution Label
(
13. Warning - Caution Label
,
)
14.
See Instructions For Use
Label
(
)
15.
PC Connection marking
(
16.
USB Port marking
(
)
17.
Nurse Call Cable
Connector Marking
(
)
18. ESD (Located inside the Device)
19. AC Mains Warning (Located Inside
Note:
The item number callouts in the following figures refer to those listed in
.
the Device)
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 1-15
Safety Information
1
5 4
Figure 1-1. Locations of Labels – Top-Front View
2
13
1-16 10071604 Rev. A
7
5
Figure 1-2. Locations of Labels – Front-Left View
Puritan Bennett™ 540 Ventilator Clinician’s Manual
Safety Information
4
16
2
Figure 1-3. Location of Labels – Front-Right View
1 9
15
6
17 3
10 13 7
Figure 1-4. Location of Labels and Markings – Back-Left View
12
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 1-17
Safety Information
4 2
5
8
NOTE: To view labels
(items 11 and 14),
Battery Cover and
Internal Battery must be removed. Refer to
section 8.6, “Replacing the Battery.”
11
Figure 1-5. Location of Labels – Bottom-Front View
14
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S ECTION
Ventilator Overview
2.1
Indications for Use
The Puritan Bennett™ 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 lb (5 kg) who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. It is essential to read, understand, and follow these instructions before using the Puritan Bennett 540 Ventilator.
Target Patients
Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:
• Positive Pressure ventilation
• Assist/Control, SIMV, or CPAP modes of invasive or non-invasive ventilation
• Breath types including Volume Control, Pressure Control, and Pressure Support
Target Environments
The ventilator is suitable for use in institutional, home, and portable settings. It is not intended for use as an emergency transport ventilator.
Target Operators
The ventilator may be operated by:
• Respiratory therapists
• Physicians
• Nurses
• Home care providers
• Patient and patient’s families
For more details on the knowledge and skill requirements for operating the Puritan Bennett
540 Ventilator, refer to Appendix A, “Patient/Caregiver Checklist”
.
Warning
Federal law restricts this device to sale by or on the order of a licensed physician.
Ventilator Overview
2.2
Contraindications
This ventilator is not for use with anesthetic gases, and is not intended for use as an emergency transport ventilator.
2.3
Operational Use
The Puritan Bennett™ 540 Portable Ventilator uses a micro-turbine and the patient circuit with integral exhalation valve to provide ventilatory support to patients. Clinicians may use a variety of interfaces to connect patients to the ventilator: nasal or full face masks; endotracheal or tracheotomy tubes. Userselectable ventilation modes are:
• Assisted Controlled Volume (VOLUME A/C)
• Assisted Controlled Pressure (PRESSURE A/C)
• Synchronous Intermittent Mandatory Ventilation Volume (V SIMV)
• Synchronous Intermittent Mandatory Ventilation Pressure (P SIMV)
• Continuous Positive Airway Pressure (CPAP)
• Pressure Support Ventilation (PSV)
Safety Net
Incorporated in the ventilator design is an alarm system that continuously monitors both patient and machine for signs of specific errors or faults that could lead to an unsafe condition. Should any of these errors or faults be detected, the alarm system announces the specific alarm condition both audibly and visually. The machine-related alarm conditions are factory set, whereas the patient-related alarm conditions are defined by alarm-threshold values selected by an operator (a clinician or a caregiver). For more
information, refer to chapter 5, “Alarms and Troubleshooting”
.
Settings
A software key, known as the “Locking Key,” restricts access to ventilation parameter settings and ventilation mode changes in order to distinguish between “clinician” usage and “patient” usage (refer to
section 7.7, “Locking the Control Panel” on page 7-18
).
Oxygen Enrichment
Oxygen may be supplied from an external, low pressure source, but the oxygen flow must be limited to 15 lpm at 7.25 psi (50 kPa, 500 mbar). The ventilator automatically compensates for the extra flow created by
the external oxygen supply (refer to chapter 6, “Installation and Assembly” .)
Breathing Circuit
The ventilator can be used with a single or double limb patient circuit. If exhaled volume monitoring is required (such as ventilator dependant patients), use the double-limb circuit for exhaled tidal volume or
Warning
Users must always possess an additional breathing circuit and valve while using the Puritan Bennett
540 Ventilator.
2-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
2.4
Device Classification
The ventilators IEC 60601-1classification is as follows:
• Protection/Insulation class (electric shock): Class II
• Protection index of enclosure: IP31
• Medical device directive classification: II B
• Degree of protection against risk of electric shock: BF
• Power: External (AC – mains, or DC – cigarette lighter) or internal (DC – battery)
• Operation mode: Continuous operation
For additional information, refer to
Appendix B, “Specifications” .
Ventilator Overview
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 2-3
Ventilator Overview
2.5
Front Panel
1
2
3
8
7
5
4
6
1 LCD Display – Displays information about the ventilator including patient hours and software version, ventilation modes and settings, and monitored and calculated patient data and waveforms. The display also allows the user to view and, using the
Control Panel, adjust the ventilator’s operating and alarm configuration settings.
2 Control Panel – Features the controls for setting up and operating the ventilator, and
LEDs to indicate the ventilator's power source, ventilation On/Off status, and alarm priority level. Control functions include turning the ventilation on and off, configuring ventilation modes, silencing and cancelling alarms, and setting device and alarm parameters.
5 Exhalation Valve Port – Nipple for providing piloting pressure to the exhalation valve. Controls the open-closed position of the exhalation valve.
6 Lateral and Front Openings – Vents that allow for air circulation to cool the ventilator’s internal components. In addition, these openings function as sound ports for audible alarms.
Warning
Do not cover or obstruct these openings.
3 Patient Connection Port – Provides an outlet for the air to be delivered to the patient via the patient circuit.
4 Patient Pressure Monitoring Port –
Nipple for monitoring proximal patient pressure.
7 From Patient Port – Exhaled volume measurements are taken from this port, through which a portion of the exhaled gas is diverted to the exhalation flow sensor. VTE is calculated from this flow measurement.
a
8 Exhaled Gas Outlet connects here.
– Exhalation Valve a. If exhaled volume monitoring is required, use the double-limb circuit for exhaled tidal volume or minute volume monitoring.
Figure 2-1. Front Panel
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Ventilator Overview
2.6
Back Panel
1
2
3
4
11
10 9
8 7 6 5
1 Ergonomic carrying handle.
2 On/Off (I/O) switch with protective cover:
Device powered on in position I; device switched off in position 0.
8
3
4
5
6
AC power (“Mains”) cable connector.
AC power (“Mains”) cable holding system:
Prevents accidental disconnection of the AC power cable.
Access cover for the internal battery.
DC power cable connector with key.
7
9
10
11
PC Cable Connector:
USB mini-B connector used for Puritan Bennett™
Ventilator Test Software.
O
2
Inlet Port:
Connects the ventilator to a low pressure oxygen source via an adaptor connected to the O
2
Inlet (refer
to section 6.8, “Oxygen” on page 6-14 ).
Nurse Call Output Connector:
Used to connect the ventilator to the nurse call
system. Refer to section 6.10, “Mounting the
Ventilator on the Utility Cart” on page 6-18
.
USB Key connection:
USB functionality to allow for system upgrades. Not currently used.
Air Inlet Filter:
Filters air as it enters the ventilator.
Figure 2-2. Back Panel
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 2-5
Ventilator Overview
2.7
Control Panel
10
9
1
2
3
4
5
8
7
6
1 Display screen:
Display of modes, ventilation settings, patient data and waveforms, configuration of the ventilator and alarm management.
6
2 Alarm indicators:
Red indicator:
• Continuous: Very High priority (VHP) alarm activated
• Flashing: High priority (HP) alarm activated
Yellow indicator:
• Medium priority (MP) alarm activated
3 ALARM CONTROL key:
• Press once to silence an audible alarm for
60 seconds.
• Press twice to halt visual and audible alarms. If alarm is remedied, the alarm is cancelled
4 UP/UNFREEZE Key:
• Moves the cursor up and increases parameter values.
• During ventilation reactivates waveform tracing in the Waveform menu.
5 ENTER key:
• Access to a setting value and validation of the modification of this setting.
• Access to a sub-menu.
7
8
9
10
DOWN/FREEZE key:
• Moves the cursor down and decreases parameter values.
• During ventilation, freezes displayed waveform in the Waveform menu.
MENU key:
Changes the displayed menu. From the Ventilation menu screen, press this key to display the Alarm menu screen.
VENTILATION ON/OFF button:
• Press briefly and release to start ventilation.
• Press for three (3) seconds to stop ventilation.
Ventilation status indicator:
• Blue indicator illuminated: device is powered on and ventilation is off (on standby).
• Blue indicator off: ventilation is on.
Electrical power source indicators:
• AC POWER indicator lit: AC power source connected.
• DC POWER indicator lit: DC power source connected.
• INTERNAL BAT indicator lit continuously: Internal battery in use (no external power source connected.)
• INTERNAL BAT indicator flashing: battery charging.
Figure 2-3. Control Panel
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Ventilator Overview
2.8
Ventilation Menu
1
Ventilation menu with ventilation on standby.
2
5
3
4
1
6
2
5
Ventilation menu during ventilation.
6
3
4
1 General information line:
Displays the current ventilation mode, along with the following:
• Battery symbol if the device is powered by the internal battery.
• Audio paused symbol if an alarm is currently inhibited.
• Alarm paused symbol if an alarm has been canceled manually and the cause of the alarm remains.
4 Bargraph:
Displays pressure generation during ventilation.
2 Ventilation settings:
Displays the specific ventilation parameter values for the currently selected ventilation mode.
Refer to chapter 3, “Operating
for more information.
3 Preference menu access line:
Highlight this line and press the
ENTER key to display the
Preference menu.
for more information.
5 Status/monitored data window: 6 Alarm conditions window:
• Ventilation stopped
(Standby): displays the message, “PRESS TO
START VENTILATION.”
• Ventilation on: parameters are monitored and displayed.
• The Inspiratory Effort
Detected symbol appears adjacent to the monitored I:E ratio when the patient actively triggers a breath.
• For Active alarms, scrolls through active alarm messages in flashing reverse video.
• For Inactive alarms, displays the last alarm along with its trigger date and end-ofevent time.
Refer to chapter 5, “Alarms and Troubleshooting” for
details.
Figure 2-4. Ventilation Menu Display
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Ventilator Overview
2.9
Alarm Menu
1
Alarm menu with ventilation on standby.
2
4
5
3
1
4
Alarm menu when not in standby.
2
5
3
1 Title line:
Displays ventilation mode and the following symbols:
• Battery if the ventilator is powered by the internal battery.
• Audio paused if an alarm is currently inhibited.
• Alarm paused if an alarm has been canceled manually and the cause of the alarm remains.
2 Alarm settings:
Displays the specific alarm parameter values for the currently selected ventilation mode, which are:
• Low and High alarm threshold settings, and
• Current monitored patient readings, or hyphen (-) when ventilation is in standby.
4 Status/monitored data window:
• Ventilation stopped
(Standby): displays the message, “PRESS TO
START VENTILATION.”
• Ventilation on: parameters are monitored and displayed.
• The Inspiratory Effort
Detected symbol appears adjacent to the monitored I:E ratio when the patient actively triggers a breath.
5 Alarm message window:
• For Active alarms, scrolls through active alarm messages in flashing reverse video.
• For Inactive alarms, displays the last alarm along with its trigger date and end-of-event time.
Refer to chapter 5, “Alarms and
for more information.
3 Access line to Alarm Log menu.
Highlight this line and press the
ENTER key to display the
Alarm Log menu.
Figure 2-5. Alarm Menu
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Ventilator Overview
2.10 Waveforms Menu
The display of waveforms ( Figure 2-6
) is optional and can be selected using the Menu key (refer to
1
2
3
1 Title line:
Displays ventilation mode and the following symbols:
• Battery if the ventilator is powered by the internal battery.
• Audio paused if an alarm is currently inhibited.
• Alarm paused if an alarm has been canceled manually and the cause of the alarm remains.
• Freeze Waveforms if the tracing of patient waveforms has
2 Graphic zone:
Displays the patient’s pressure and flow waveforms as a function of time.
For more information,refer to chapter 4, “Monitored
3 Numeric zone:
Displays monitored data.
Figure 2-6. Waveforms Menu
2.11 If Ventilator Failure Occurs
If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER. If necessary, remove the patient from the ventilator and provide an alternate means of ventilation.
Keep in mind that troubleshooting information is available in this manual to assist you in the event of a
problem. Refer to chapter 5, “Alarms and Troubleshooting” .
If you cannot determine the cause of a problem, contact your equipment supplier or Covidien.
Covidien Technical Services (USA):
1-800-255-6774
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S ECTION
Operating Parameters
This chapter describes ventilation and alarm parameters and their setting ranges for each ventilation mode. For a listing of operating parameters and monitored patient data, refer to
Table B-11 on page B-5. For further information about the different ventilation modes and
breath types provided by the Puritan Bennett™ 540 Ventilator, refer to
Appendix D, “Modes and Breath Types.”
Warning
• If APNEA TIME is set to a value higher than 60/Control R then the APNEA alarm will not activate.
3.1
PSV/CPAP Mode Parameters and Setting
Ranges
Menus and parameters for the following two modes are shown below:
• PSV - Pressure Support Ventilation
• CPAP - Continuous Positive Airway Pressure
Figure 3-1. Menus in PSV Mode
Operating Parameters
3-2
Figure 3-2. Menus in CPAP Mode
The ventilation parameters and setting ranges available in PSV/CPAP mode are listed in Table 3-1 .
Table 3-1. Ventilation Parameters in PSV/CPAP Menu
Name
P Support
PEEP a
Rise Time
Insp Sens b
Exh Sens c
PSV: Backup
Apnea Time
Low I Time d
High I Time
Units cmH
2
O cmH
2
O
–
–
% bpm s s s
Min. Value
5
0
1
1P
5
5
1
0.1
0.8
Max. Value
55
20
4
5
95
40
60
3
3
Adjustment
Resolution
1
1
1
1
5
1
1
0.1
0.1
Default
Value
15
OFF
2
2
25
OFF
Auto
Auto
Auto
Linked
Parameters
PEEP
P Support
Insp Time
–
–
Low I Time
Backup R
Backup R
High I Time
Rise Time
Low I Time
R-Rate a. Min value = 2 in CPAP b. In CPAP mode, Insp Sens cannot be adjusted. Its default value is set to 2.
c. In CPAP, Exh Sens cannot be adjusted. Its default value is set to 25 d. Low I Time and High I Time are set from the Alarm menu screen and, in CPAP mode, cannot be adjusted at all; instead, they are automatically set to their default setting (AUTO).
Table 3-2 lists the available alarm settings in PSV/CPAP mode.
Table 3-2. Alarm Parameters in PSV/CPAP Mode
Name
Low VTI
High VTI
Low VTE
High VTE
Low Min Vol
High Min Vol
High Rtot
Units ml ml ml ml l l bpm
Min. Value
30
80
30
80
0.5
2.0
10
Max. Value
2,000
3,000
1,900
3,000
50
99
70
Adjustment
Resolution
10
10
10
10
0.5
0.5
1
Default
Value
300
2,000
300
1000
4.0
13.0
OFF
Linked
Parameters
High VTI
Low VTI
High VTE
Low VTE
High Min Vol
VTI
R-Rate
Low Min Vol
VTI
R-Rate
Backup R
10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Operating Parameters
P Support – Pressure Support
P support allows you to determine pressure added to PEEP during the inspiratory phase.
The sum of Pressure support and PEEP must not exceed 55 cmH
2
O.
When P Support is set to OFF the ventilator displays the settings of CPAP parameters only (P Support,
PEEP, and Apnea Time).
Warning
The CPAP mode does not feature control cycles. Do not use this mode for ventilator-dependent patients.
PEEP – Positive End Expiratory Pressure
PEEP allows you to determine the level of pressure maintained during the expiratory phase.
P Support and PEEP are additive and their sum must not exceed 55 cmH
2
O.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 cmH
2
O when set to “OFF”).
In the CPAP mode, set PEEP to determine the level of pressure maintained during the inspiratory phase and the expiratory phase.
Rise Time
This parameter is used during the inspiration phase to determine how the target pressure will be reached.
This setting indirectly defines the minimum inspiratory time.
The different levels available are as follows:
Rise time
Rise time
Rise time
Rise time
= 200 ms
= 400 ms
= 600 ms
= 800 ms
These time ranges are determined by the pressure setting required, the breath rate , and the physiological condition of the patient.
Insp Sens – Inspiratory Trigger Sensitivity
Insp Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath.
The sensitivity levels decrease from 1P to 5: the lower the number, the more sensitive the trigger sensitivity.
These levels correspond to differences in flow compared to the bias flow. The flow levels fall linearly as shown below:
Table 3-3. AC Inspiratory Trigger Sensitivity
Insp Sens
5
5
5
PEEP
0 to 5
6 to 10
11 to 20
Minimum Flow (LPM)
Required to Trigger*
8
9
10
4
4
4
0 to 5
6 to 10
11 to 20
7
8
9
3
3
0 to 5
6 to 10
6
7
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-3
Operating Parameters
Table 3-3. AC Inspiratory Trigger Sensitivity (Continued)
3 11 to 20 8
2
2
2
0 to 5
6 to 10
11 to 20
5
6
7
1P
1P
1P
0 to 5
6 to 10
11 to 20
3
4
5
*Stated minimum trigger flow may vary +10%
The flow values in the table above are indicative values given for a particular test setup and are intended to show the sensitivity variation against the PEEP and insp sens setting configurations. They are not intended to be compared to simple flow-by threshold triggering commonly used by other ventilators.
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled air (CO
2
).
The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms, depending on the preceding peak inspiratory flow.
Caution
Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering. Level 1P, the most sensitive inspiratory trigger, is recommended for pediatric use. For an adult, this setting may result in ventilator autotriggering.
In CPAP mode, Insp Sens cannot be adjusted. Its default value is set to 2.
Exh Sens – Exhalation Trigger Sensitivity
Exh sens is available in the PSIMV, VSIMV, and PSV mode. In CPAP, exh sens is defaulted to 25% and is not adjustable.
Exh Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.
The end of inspiration will occur when Inspiratory Flow has decreased to the preset Exh Sens setting.
The expiratory trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.
If the flow drop is insufficient, exhalation is automatically triggered independently of the Exh Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time of three (3) seconds has elapsed, which corresponds to an I:E Ratio of 1:1.0, to ensure that the patient has enough time to exhale.
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The following graph describes exhalation trigger sensitivity:
Operating Parameters
Backup R
Backup R allows you to determine the frequency of ventilation breaths to be applied in the event of prolonged apnea – as long as no inspiratory trigger is detected.
The inspiratory time of the backup breaths applied in the event of apnea still depends on the detection of
Exhalation trigger (Exh Sens) and the safety maximum inspiratory time (see above comment on Exh Sens).
The rise time of these cycles is identical to the ventilation cycle previously set.
The controlled cycles following apnea are interrupted as soon as a new spontaneous inspiration of the patient is detected.
The Backup R is linked to the Low I Time so that the Low I Time setting cannot be greater than half the inspiratory phase of a ventilator controlled breath.
Backup R breath is delivered at the Pressure Support settings.
Setting a Backup Rate is not optional; it is always set.
In the CPAP mode (P Support set to OFF) the Backup R setting is not available.
Apnea Time
Apnea time allows the user to monitor and detect interruptions to the patient's spontaneous breathing pattern. The ventilator declares apnea when no breath has been delivered by the time that the operatorselected apnea interval elapses. The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (60/Backup Rate setting). In CPAP mode, the Apnea Time defaults to auto = 30 seconds.
Note:
• During apnea ventilation, the ventilator delivers machine controlled breaths according to a backup rate
(Backup R) – as long as no inspiratory trigger has been detected.
• The Backup R value applied depends on the R-Rate setting.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-5
Operating Parameters
Low and High I Time – LOW / HIGH INSPIRATORY TIME
Low I Time and High I Time are ventilation parameters that can be adjusted in the alarm menu.
Low I Time defines the minimum duration of time the inspiratory phase is maintained. It takes priority over activation of the expiratory trigger which can only be triggered after the Low I Time has expired.
The Backup R is linked to the Low I Time so that the Low I Time setting cannot be greater than half the inspiratory phase of a cycle triggered by the ventilator.
If Backup R is changed, Low I Time is, if necessary, automatically readjusted so that the difference between them is always maintained.
The minimum time by default if no parameter is set (Low I Time = AUTO) corresponds to the lower value in the range of the Rise Time to which an operating margin of 0.3 seconds is added (AUTO equals Rise Time
+ 0.3 seconds). See “Rise Time” on page 3-3 for details about Rise Time.
High I Time defines the maximum duration of time during which the inspiratory phase is maintained. The switch-over to exhalation occurs , at the latest , after this time has expired.
By default, if no parameter is set, the maximum time (High I Time = AUTO) is the shortest time between a fixed time of three (3) seconds and half the duration of the patient’s inspiratory breaths expressed in seconds. This default value will be applied if it is lower than the High I Time setting.
Low I Time and High I Time are related so that the High I Time cannot be set to a value lower than the Low I
Time.
In CPAP mode, High and Low I Time cannot be set and are automatically set to their default setting , which is AUTO.
VTI (Low and/or High Alarm Settings) – INSPIRATORY TIDAL VOLUME
It is possible to set a low and/or high Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.
This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW INSP VOLUME” alarm) or greater than the maximum threshold set (“HIGH INSP
VOLUME” alarm). Refer to chapter 5, “Alarms and Troubleshooting” .
Low VTI and High VTI are related, and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
VTE (Low and/or High Alarm Settings) – EXPIRATORY TIDAL VOLUME
Use a double limb patient circuit configuration when setting the low and/or high Expiratory Tidal Volume alarm parameters.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW EXH VOLUME” alarm) or greater than the maximum threshold set
(“HIGH VTE” alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
LOW VTE and HIGH VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
Although the patient's exhaled tidal volumes are always displayed when using a double limb patient circuit, it is not mandatory to set the low and high VTE alarm limits. When the low and high VTE alarm limits are not set, the display will read “OFF” for these settings.
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Operating Parameters
Min Vol (Low and/or High Alarm Settings) – MINUTE VOLUME
It is possible to set an alarm threshold for the average minimum and/or maximum Minute Volume inspired by the patient for one minute.
This setting is used to trigger an alarm if the average volume received by the patient is lower than the minimum threshold set (“LOW MINUTE VOLUME” alarm) or greater than the maximum threshold set
(“HIGH MINUTE VOLUME” alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
Low Min Vol and High Min Vol are related and their settings must be set to values that maintain a minimum difference between the two of 1 liter.
Setting Low VTE and High VTE is not mandatory (they can be set to “OFF”) , but the measured value is always displayed.
Rtot (High Rate Alarm Setting) – HIGH RATE
The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering.
The alarm setting is used to trigger the “HIGH RATE” alarm. Refer to chapter 5, “Alarms and
.
When set, the High Rtot threshold must always exceed the Backup Rate by 5 bpm. If the Backup Rate is readjusted, the High Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.
Setting the High Rtot is not mandatory (it can be set to “OFF”) , but the measured value is always displayed.
3.2
Pressure A/C Mode Parameters and Setting Ranges
The menus in PRES A/C (Assisted/Controlled Pressure) ventilation mode are shown in
.
Figure 3-3. Menus in PRES A/C Mode
The Ventilation parameters adjustable in PRES A/C mode are listed in
Table 3-4. Ventilation Parameters in PRES A/C Mode Menu
Name
P Control
PEEP
Rise Time
Units cmH
2
O cmH
2
O
–
Min.
Value
5
0 (OFF)
1
Max.
Value
55
20
4
Adjustment
Resolution
1
1
1
Default
Value
15
OFF
2
R-Rate
Insp Time
Insp Sens bpm s
–
5
0.3
1
60
6
5
1
0.1
1
13
1.5
2
Linked Parameters
PEEP
P Control
Insp Time
High Rtot
Insp Time
Vt
R-Rate
Vt
–
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-7
Operating Parameters
Table 3-5 lists the adjustable alarm parameters in PRES A/C mode.
Table 3-5. Alarm Parameters in PRES A/C Mode
Name
Low VTI
High VTI
Low VTE
High VTE
Low Min Vol
High Min Vol
High Rtot
Units ml ml ml ml l l bpm
Min.
Value
30
80
30
80
0.5
2
10
Max.
Value
2,000
3,000
1,990
3,000
50
99
70
Adjustment
Resolution
10
10
10
10
0.1
0.1
1
Default
Value
300
2000
300
1000
4.0
13.0
OFF
Linked Parameters
High VTI
Low VTI
High VTE
Low VTE
High Min Vol
Low Min Vol
R-Rate
P Control – PRESSURE CONTROL
P Control allows you to determine the pressure added to the PEEP during the inspiratory phase.
The sum of Pressure control and PEEP must not exceed 55 cmH
2
O.
PEEP – POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the level of pressure maintained during the expiratory phase.
P Control and PEEP are related and their sum must not exceed 55 cmH
2
O.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 cmH
2
O when set to “OFF”).
Rise Time
This parameter is used during the inspiration phase to adjust how the pressure setpoint will be reached. This setting indirectly defines the minimum inspiratory time.
The different levels available are as follows:
• Rise time
• Rise time
• Rise time
• Rise time
= 0.2 to 0.7 seconds
= 0.4 to 1.0 seconds
= 0.6 to 1.2 seconds
= 0.8 to 1.5 seconds
These time ranges are determined by the combination of the pressure setting required, the breath rate and the physiological conditions of the patient.
The pressure rise time built-up at each cycle depends on the inspiratory time corresponding to the combination of the rate setting and the Insp Time setting.
• Rise Time
• Rise Time
• Rise Time
• Rise Time
is always possible
is established only if Insp Time
≥
0.7 seconds
is established only if Insp Time
≥
0.9 seconds
is established only if Insp Time
≥
1.1 seconds.
R-Rate – RESPIRATORY RATE
R-Rate allows you to define the minimal frequency of mandatory ventilator breaths.
If the patient actuates the inspiration trigger, Total R may increase.
R-Rate and Insp Time are related so that the Insp Time must always be between 20% and 80% of the ventilation cycle duration , which is determined by R-Rate:
(0.2 x 60 / R-Rate < Insp Time < 0.8 x 60 / R-Rate)
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Operating Parameters
Insp Time – INSPIRATORY TIME
Insp Time allows you to determine the inspiratory phase duration of breaths triggered by the patient or by the ventilator.
R-Rate and Insp Time are related so that the Insp Time must always be between 20% and 80% of the ventilation cycle duration determined by:
(0.2 x 60 / R-Rate < Insp Time < 0.8 x 60 / R-Rate).
Warning
An INVERSED I:E RATIO alarm is triggered when the Insp Time exceeds exhalation time. Before confirming such a setting, ensure it is compatible with the physiological requirements of the patient.
Insp Sens – INSPIRATORY TRIGGER SENSITIVITY
Insp Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.
The sensitivity levels decrease from 1P to 5; the higher the index, the less sensitive the trigger sensitivity.
These levels correspond to differences in flow compared to the bias flow as shown below:
Table 3-6. AC Inspiratory Trigger Sensitivity
Insp Sens
5
5
5
PEEP
0 to 5
6 to 10
11 to 20
3
3
3
4
4
4
2
2
2
0 to 5
6 to 10
11 to 20
0 to 5
6 to 10
11 to 20
0 to 5
6 to 10
11 to 20
Minimum Flow (LPM)
Required to Trigger*
8
9
10
7
8
9
5
6
7
6
7
8
1P
1P
1P
0 to 5
6 to 10
11 to 20
3
4
5
*Stated minimum trigger flow may vary +10%
The flow values in the table above are indicative values given for a particular test setup and are intended to show the sensitivity variation against the PEEP and insp sens setting configurations. They are not intended to be compared to simple flow-by threshold triggering commonly used by other ventilators.
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled air (CO
2
).
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-9
Operating Parameters
The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow.
Caution
Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering. Level 1P, the most sensitive inspiratory trigger, is recommended for pediatric use. For an adult, this setting may result in ventilator autotriggering.
VTI (Low and/or High Alarm Settings) – INSPIRATORY TIDAL VOLUME
It is possible to set a Low and/or High Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.
This setting is used to trigger an alarm if the tidal volume inspired by the patient is lower than the minimum threshold set (“LOW INSP VOLUME” alarm) , or greater than the maximum threshold set (“HIGH INSP
VOLUME” alarm). Refer to chapter 5, “Alarms and Troubleshooting” .
Low VTI and High VTI are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
VTE (Low and/or High Alarm Settings) – EXPIRED TIDAL VOLUME
A Low and/or High Tidal volume expired by the patient can always be set but can only be used in a double limb circuit configuration.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW EXH VOLUME” alarm) or greater than the maximum threshold set
(“HIGH VTE” alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
LOW VTE and HIGH VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
Setting Low VTE and High VTE is not mandatory (they can be set to “OFF”) , but the display of the measured value is always active in double limb configuration.
Min Vol (Low and/or High Alarm Settings) – MINUTE VOLUME
It is possible to set an alarm threshold for the average minimum and/or maximum volume inspired by the patient for one minute (minute volume).
This setting is used to trigger an alarm if the average volume received by the patient is lower than the minimum threshold set (“LOW MINUTE VOLUME” alarm) or greater than the maximum threshold set
(“HIGH MINUTE VOLUME” alarm).
Low Min Vol and High Min Vol are related and their settings must maintain a minimum difference between them of 1 liter.
Setting Low Min Vol and High Min Vol is not mandatory (set to “OFF”); however, the display of the measured value is always active.
Rtot (High Alarm Setting) – HIGH RATE
The maximum rate threshold setting is used to warn of hyperventilation or autotriggering of the ventilator.
.
The High Rtot threshold must always be set at least 5 bpm higher than the R-Rate. If the R-Rate is readjusted, the High Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.
Setting the High Rtot is not mandatory (it can be set to “OFF”) , but the measured value is always displayed.
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Operating Parameters
3.3
Volume A/C Mode Parameters and Setting Ranges
The menus in the VOL A/C (Assisted/Controlled Volume) ventilation mode are shown in
.
Figure 3-4. Menus in the VOL A/C Mode
The ventilation parameters that are adjustable in the VOL A/C mode are shown in
Table 3-7. Ventilation Parameters in VOL A/C Ventilation Mode
Name Units
Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Vt
PEEP
Flow Pattern
R-Rate
Insp Time
Insp Sens ml cmH
2
O
– bpm s
–
50
0 (OFF)
SQ
5
0.3
1
2000
20
D
60
6
5
10
1
–
1
0.1
1
500
OFF
D
13
1.5
2
Linked Parameters
Insp Time
R-Rate
Low VTE
High VTE
Low Min Vol
High Min Vol
Low PIP
High PIP
–
Insp Time
Vt
High Rtot
Low Min Vol
High Min Vol
Vt
R-Rate
–
The alarm parameters adjustable in VOL A/C mode are as follows:
Table 3-8. VOL A/C Mode Alarm Parameters
Name Units
Min.
Value
Max.
Value
Adjustment
Resolution
Low PIP cmH
2
O 2 52 1
High PIP
Low VTE
High VTE cmH
2
O ml ml
12
30
80
60
1,900
3,000
1
10
10
Default
Value
2
40
300
1000
Linked Parameters
PEEP
High PIP
PEEP
Low PIP
Vt
High VTE
Vt
Low VTE
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-11
Operating Parameters
Table 3-8. VOL A/C Mode Alarm Parameters (Continued)
Name Units
Min.
Value
Max.
Value
Adjustment
Resolution
Low Min Vol
High Min Vol
High Rtot l l bpm
0.5
2
10
50
99
70
0.5
0.5
1
Default
Value
4.0
13.0
OFF
Linked Parameters
Vt
R-Rate
High Min Vol
Vt
R-Rate
Low Min Vol
R-Rate
Vt – VOLUME CONTROL
Vt allows you to set the tidal volume to be delivered to the patient at each inspiratory phase.
For physiological and safety reasons, the Vt setting is limited by the settings of Insp Time and R-Rate.
The ratio of Vt to Insp Time (Vt / Insp Time) is [3< (Vt x 60) / (InspTime x 1000) < 100].
The product of Vt x R-Rate must be between the Low Min Vol + 0.5 liter and High Min Vol - 0.5 liter:
Low Min Vol + 0.5 liter ≤ Vt x R-Rate / 1000 ≤ High Min Vol - 0.5 liter
Warning
Ensure that the patient circuit is appropriate for the tidal volume setting (tube Ø 22 mm for adults, and
Ø 15 mm for pediatric tidal volumes lower than 200 ml).
PEEP – POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the level of pressure maintained during the expiratory phase.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 cmH
2
O when set to “OFF”).
Flow Pattern – FLOW SHAPE
This parameter is used to adjust the flow distribution shape (or flow pattern) during the inspiratory phase.
The two flow patterns available are:
• Flow Pattern:
• Flow Pattern:
(square waveform) or constant flow
Decelerated (sawtooth waveform) or decreasing flow
R-Rate – RESPIRATORY RATE
R-Rate allows you to define the frequency of ventilation cycles triggered by the ventilator.
If the patient actuates the inspiratory trigger, Total R may increase.
For physiological and efficiency reasons, R-Rate setting is limited by the settings of Vt and Insp Time.
R-Rate and Vt are related so that the product of Vt x R-Rate must fall between the set limit of
Low Min Vol + 0.5 liters and High Min Vol - 0.5 liters:
Low Min Vol + 0.5 liters ≤ Vt x R-Rate / 1000 ≤ High Min Vol - 0.5 liters
R-Rate and Insp Time are related so that the Insp Time must always fall between 20% and 80% of the breath ventilation cycle , as determined by R-Rate:
0.2 x 60 / R-Rate < Insp Time < 0.66 x 60 / R-Rate
Insp Time – INSPIRATORY TIME
Insp Time allows you to determine the inspiratory breath phase duration.
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Operating Parameters
For physiological and safety reasons, its setting is limited by the settings of Vt and R-Rate.
The ratio of Vt to Insp Time (Vt / Insp Time) is [3 < (Vt x 60) / (InspTime x 1000) < 100].
R-Rate and Insp Time are related so that the Insp Time must always fall between 20% and 80% of the ventilator breath cycle duration , as determined by R-Rate:
0.2 x 60 / R-Rate < Insp Time < 0.66 x 60 / R-Rate
Warning
An INVERSED I:E RATIO alarm is triggered when the Insp Time exceeds exhalation time. Before confirming such a setting, ensure it is compatible with the physiological requirements of the patient.
Insp Sens – INSPIRATORY TRIGGER SENSITIVITY
Insp Sens allows you to set the level of patient inspiratory effort to initiate a machine control breath.
The sensitivity levels from 1P to 5 are decreasing: the higher the index, the less sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow as shown below:
Table 3-9. Volume A/C Inspiratory Trigger Sensitivity
Insp Sens
5
5
5
PEEP
0 to 5
6 to 10
11 to 20
Minimum Flow (LPM)
Required to Trigger*
8
9
10
3
3
3
4
4
4
2
2
2
0 to 5
6 to 10
11 to 20
0 to 5
6 to 10
11 to 20
0 to 5
6 to 10
11 to 20
6
7
8
7
8
9
5
6
7
1P
1P
1P
0 to 5
6 to 10
11 to 20
3
4
5
*Stated minimum trigger flow may vary +10%
The flow values in the table above are indicative values given for a particular test setup and are intended to show the sensitivity variation against the PEEP and insp sens setting configurations. They are not intended to be compared to simple flow-by threshold triggering commonly used by other ventilators.
The bias flow consists of turbine flow through the patient circuit that helps the patient avoid rebreathing exhaled air (CO
2
) during the exhalation phase.
The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-13
Operating Parameters
Caution
Set the trigger threshold carefully to minimize the risk of ventilator autotriggering. Level 1P, the most sensitive setting inspiratory trigger, is recommended for pediatric use. For an adult, this setting may cause ventilator autotriggering.
PIP (Low and High Alarm Settings) – PEAK INSPIRATORY PRESSURE
A minimum and maximum inspiratory pressure alarm threshold must be set.
The Low PIP (or Low Pressure) setting determines the trigger threshold for the “LOW PRESSURE
DISCONNECT“ alarm. Refer to chapter 5, “Alarms and Troubleshooting” . If this pressure level is not
reached during a fixed time, the alarm is triggered.
Warning
The setting of the Low PIP alarm must be adjusted for the patient, but must also be set high enough to allow the LOW PRESSURE DISCONNECT alarm to trigger properly. Perform the Low Pressure Test (refer to
section F.1, “Low Pressure Test,” on page F-1 ) to ensure the Low PIP alarm is properly set.
The High PIP or High Pressure setting determines the level of pressure which is not to be exceeded during the inspiratory phase. Once this level is reached, inspiration is terminated, ventilation switches to
exhalation, and a “High PIP“ alarm is triggered. Refer to chapter 5, “Alarms and Troubleshooting”
.
The difference between the Low PIP and High PIP settings is limited to a minimum of 8 cmH
2
O.
This setting is also limited by the setting of PEEP; thus, the Low PIP setting must exceed the PEEP setting by at least 2 cmH
2
O. In addition, the High PIP setting must exceed the PEEP setting by at least 10 cmH
2
O.
A change in the PEEP level may lead to automatic changes in the Low PIP and/or High PIP thresholds, in order to maintain these setting differences.
VTE (Low and/or High Alarm Settings) – EXPIRED TIDAL VOLUME
Low and/or high expired tidal volume settings are adjustable, but can only be used with a double limb circuit configuration.
These thresholds can be set to trigger an alarm if the tidal volume expired by the patient is lower than the minimum threshold set (“LOW EXH VOLUME“ alarm) or greater than the maximum threshold set
(“HIGH VTE“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
Low VTE and High VTE are linked to Vt so that Vt must be greater than Low VTE by at least 10 ml but lower than High VTE by at least 10 ml.
If Vt is changed, Low VTE and High VTE are automatically readjusted so that the difference between them is always maintained.
Setting Low VTE and High VTE is not mandatory (they can be set to “OFF“, which is the default setting), but the measured value is always displayed when using double limb configurations.
Min Vol (Low and/or High Alarm Settings) – MINUTE VOLUME
It is possible to set an alarm threshold for the average minimum and/or maximum Minute Volume inspired by the patient for one minute.
This setting is used to trigger an alarm if the average volume received by the patient is lower than the minimum threshold set (“LOW MINUTE VOLUME“ alarm) or greater than the maximum threshold set
(“HIGH MINUTE VOLUME“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
Low Min Vol and High Min Vol are related and there must be a minimum difference of 1 liter between the two settings.
Low Min Vol and High Min Vol are also related to Vt and R-Rate so that the product of Vt x R-Rate must be greater than or equal to High Min Vol - 0.5 liter.
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Operating Parameters
If Vt is changed, Low Min Vol and High Min Vol are automatically readjusted so that the difference between them is always maintained.
Setting Low Min Vol and High Min Vol is not mandatory (they may be set to “OFF“, which is the default setting), but the measured value is always displayed.
Rtot (High Alarm Setting) – HIGH RATE
The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering. Its setting
is used to trigger the “HIGH RATE“ alarm. Refer to chapter 5, “Alarms and Troubleshooting”
.
When set, the High Rtot threshold must always exceed the R-Rate setting by at least 5 bpm. If the
R-Rate is readjusted, the High Rtot is automatically readjusted to maintain a minimum difference of
5 bpm.
Setting the High Rtot is not mandatory (it can be set to “OFF“, the default setting), but the measured value is always displayed.
3.4
Pressure SIMV Mode Parameters and Setting Ranges
The menus in the P SIMV (Spontaneous Intermittent Mandatory Ventilation Pressure) ventilation mode are
Figure 3-5. Menus in P SIMV Ventilation Mode
shows the adjustable Ventilation parameters in P SIMV mode.
Table 3-10. Ventilation Parameters in P SIMV Ventilation Mode
Name
P Control
P Support
PEEP
Rise Time
Units cmH
2
O cmH
2
O cmH
2
O
–
Min.
Value
5
5
0 (OFF)
1
Max.
Value
55
55
20
4
Adjustment
Resolution
1
1
1
1
Default
Value
15
15
OFF
2
R-Rate bpm 1 40 1 13
Insp Time
Exh Sens
Insp Sens
Apnea Time s
%
– s
0.3
5
1
1
2.4
95
5
60
0.1
5
1
1
shows the adjustable alarm parameters in P SIMV mode.
1.5
25
2
Auto
Linked Parameters
PEEP
PEEP
P Control
P Support
Insp Time
High Rtot
Insp Time
R-Rate
Vt
–
–
Backup R
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-15
Operating Parameters
Table 3-11. Alarm Parameters in P SIMV Ventilation Mode
Name
Low VTI
High VTI
Low VTE
High VTE
Low Min Vol
High Min Vol
High Rtot
Units ml ml ml ml l l bpm
Min.
Value
30
80
30
80
0.5
2.0
17
Max.
Value
2,000
3,000
1,900
3,000
50
99
70
Adjustment
Resolution
10
10
10
10
0.5
0.5
1
Default
Value
300
2000
300
1000
4.0
13.0
OFF
Links
High VTI
Low VTI
High VTE
Low VTE
High Min Vol
Low Min Vol
R-Rate
P Control – PRESSURE CONTROL
P Control allows you to determine the target pressure above PEEP during the inspiratory phase of the controlled pressure ventilator cycles.
The sum of P Control and PEEP must not exceed 55 cmH
2
O.
P Support – PRESSURE SUPPORT
P Support allows you to determine the pressure added to the PEEP during the inspiratory phase of the spontaneous pressure cycles triggered by the patient.
The sum of P Support and PEEP must not exceed 55 cmH
2
O.
PEEP – POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the level of pressure maintained during the expiratory phase.
PEEP is related to P Support and P Control and their sum (P Support + PEEP or P Control + PEEP) should not exceed 55 cmH
2
O.
The ventilation mode can be adjusted without PEEP (PEEP is nearly equal to 0 cmH
2
O when set to “OFF“).
R-Rate – RESPIRATORY RATE
R-Rate is the rate at which the ventilator control pressure cycles are initiated, excluding apnea phases.
R-Rate and Insp Time are related so that if R-Rate is greater than 12 bpm, then Insp Time must be between
20% and 80% of the breath cycle duration as determined by R-Rate:
INSP Time < 0.33 x 60 /R Rate if Control R ≥ 8
INSP Time ≤ 2.4 if control R < 8
Note:
• During apnea ventilation, the ventilator delivers controlled breaths according to a Backup Rate (Backup R) as long as no inspiratory trigger has been detected.
• The Backup R value applied depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and is equal to the R-Rate value if R-Rate is greater than 8 bpm.
Insp Time - INSPIRATORY TIME CONTROLLED
Insp Time allows you to determine the duration of the inspiratory phase of controlled breaths triggered by the ventilator and is limited to a 1:2 or greater I:E ratio.
Backup R and Insp Time are related.
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Operating Parameters
Insp Sens – INSPIRATORY TRIGGER SENSITIVITY
Insp Sens sets the level of patient inspiratory effort required to trigger a machine breath.
The sensitivity levels decrease from 1P to 5: the higher the index, the less sensitive the trigger sensitivity.
These levels correspond to differences in flow as compared to the bias flow as shown below:
Table 3-12. Pressure SIMV Inspiratory Trigger Sensitivity
Insp Sens
5
5
5
PEEP
0 to 5
6 to 10
11 to 20
Minimum Flow (LPM)
Required to Trigger*
8
9
10
3
3
3
4
4
4
2
2
2
0 to 5
6 to 10
11 to 20
0 to 5
6 to 10
11 to 20
0 to 5
6 to 10
11 to 20
6
7
8
7
8
9
5
6
7
1P
1P
1P
0 to 5
6 to 10
11 to 20
3
4
5
*Stated minimum trigger flow may vary +10%
The flow values in the table above are indicative values given for a particular test setup and are intended to show the sensitivity variation against the PEEP and insp sens setting configurations. They are not intended to be compared to simple flow-by threshold triggering commonly used by other ventilators.
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled air (CO
2
).
The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow.
Caution
Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering. Level 1P, the most sensitive inspiratory trigger, is recommended for pediatric use. For an adult, this setting may result in ventilator autotriggering.
Apnea Time
Apnea time allows the user to monitor and detect interruptions to the patient's spontaneous breathing pattern. The ventilator declares apnea when no breath has been delivered by the time that the operatorselected apnea interval elapses. Apnea Time “AUTO” setting (in seconds) is calculated using the formula
(60/Backup Rate setting).
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Operating Parameters
Note:
• During apnea ventilation, the ventilator delivers machine controlled breaths according to a Backup Rate
(Backup R) – as long as no inspiratory trigger has been detected.
• The Backup R value applied depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the R-Rate value if R-Rate is greater than 8 bpm.
I Time (Low and High Settings)
The minimum (Low I) and maximum (High I) duration of the inspiratory phase cannot be set in V SIMV or
P SIMV mode. In both the P SIMV and V SIMV modes, the Low I Time defaults to a setting equal to RISE
TIME + 300 ms and the High I Time defaults to the lesser of 3 seconds or 30/R-Rate.
Rise Time
The Rise Time during the inspiratory phase can be set in P SIMV mode and the range is 1-4. The device is configured with a default Rise Time setting of two (2) (or a pressure rise time of 0.4 s to 1.0 s).
Exh Sens – Exhalation Trigger Sensitivity
Exh sens is available in the PSIMV, VSIMV, and PSV mode. In CPAP, exh sens is defaulted to 25% and is not adjustable.
Exh Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.
The end of inspiration will occur when Inspiratory Flow has decreased to the preset Exh Sens setting.
The expiratory trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.
If the flow drop is insufficient, exhalation is automatically triggered independently of the Exh Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time of three (3) seconds has elapsed, which corresponds to an I:E Ratio of 1:1.0, to ensure that the patient has enough time to exhale.
The following graph describes exhalation trigger sensitivity:
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Operating Parameters
VTI (Low and/or High Alarm Settings) – INSPIRATORY TIDAL VOLUME
It is possible to set a Low and/or High Tidal Volume alarm threshold for the patient’s inspired tidal volume.
This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW INSP VOLUME“ alarm) or greater than the maximum threshold set (“HIGH INSP
VOLUME“ alarm). Refer to chapter 5, “Alarms and Troubleshooting” .
Low VTI and High VTI are related and their setting must maintain a minimum difference of 20 ml between them.
VTE (Low and/or High Alarm Settings) – EXPIRED TIDAL VOLUME
A Low and/or High Tidal volume expired by the patient can be set but can only be used in a double limb circuit configuration.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW EXH VOLUME“ alarm) or greater than the maximum threshold set
(“HIGH VTE“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
LOW VTE and HIGH VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between them.
Setting Low VTE and High VTE is not mandatory (set to “OFF“), but the display of the measured value is always active in double limb configuration.
Min Vol (Low and/or High Alarm Settings) – MINUTE VOLUME
It is possible to set an alarm threshold for the average minimum and/or maximum Minute Volume inspired by the patient for one minute.
This setting is used to trigger an alarm if the average volume received by the patient is lower than the minimum threshold set (“LOW MINUTE VOLUME“ alarm) or greater than the maximum threshold set
(“HIGH MINUTE VOLUME“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
Low Min Vol and High Min Vol are related and their setting must maintain a minimum difference between them of 1 liter.
Setting Low Min Vol and High Min Vol is not mandatory (set to “OFF“), but the display of the measured value is always active.
Rtot (HIGH Alarm Setting) – HIGH RATE
The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering. Its setting
is used to trigger the “HIGH RATE“ alarm. Refer to chapter 5, “Alarms and Troubleshooting”
.
When set, the High Rtot threshold must always exceed the R-Rate setting by at least 5 bpm. If the R-Rate is readjusted, the High Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.
Setting the High Rtot is not mandatory (it can be set to “OFF“, the default setting), but the measured value is always displayed.
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Operating Parameters
3.5
Volume SIMV Mode Parameters and Setting Ranges
The menus in the V SIMV (Spontaneous Intermittent Mandatory Ventilation Volume) ventilation mode are
Figure 3-6. Menus in V SIMV Ventilation Mode
shows the adjustments and limits in the V SIMV mode.
Table 3-13. Ventilation Parameters in V SIMV Mode
Name Units
Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Vt
P Support
PEEP
Rise Time
R-Rate
Insp Time
Exh Sens
Insp Sens
Apnea Time ml cmH
2
O cmH
2
O
– bpm s
%
– s
50
5
0 (OFF)
1
1
0.3
5
1
1
2000
55
20
4
40
2.4
95
5
60
10
1
1
1
1
0.1
5
1
1
500
15
OFF
13
13
1.5
25
2
Auto
Links
R-Rate
Insp Time
Low VTE
High VTE
Low Min Vol
High Min Vol
Low VTI
High VTI
PEEP
Low PIP
High PIP
P Support
High PIP
Low PIP
Insp Time
Vt
High Rtot
Low Min Vol
High Min Vol
Insp Time
Vt
R-Rate
–
R-Rate
Backup R
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Operating Parameters
Alarm parameters that are adjustable in the V SIMV mode menu and their adjustment limits are listed in
.
Table 3-14. Alarm Parameters in the V SIMV Mode Menu
Name Units
Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Low PIP
High PIP
Low VTI
High VTI
Low VTE
High VTE
Low Min Vol
High Min Vol
High Rtot cmH
2
O cmH
2
O ml ml ml ml l l bpm
2
12
30
80
30
80
OFF
2
10
52
60
2000
3000
2000
3000
50
99
70
1
1
10
10
10
10
0.5
0.5
1
2
40
300
2000
300
1000
4.0
13.0
OFF
Links
P Support
PEEP
High PIP
P Support
PEEP
Low PIP
Vt
High VTI
Vt
Low VTI
Vt
High VTE
Vt
Low VTE
Vt
R-Rate
High Min Vol
Vt
R-Rate
Low Min Vol
R-Rate
Vt – VOLUME CONTROL
Vt allows you to set the tidal volume delivered to the patient at each inspiration phase of intermittent or successive controlled breath cycles (triggered by the ventilator) in the event of patient apnea.
For physiological and safety reasons, the Vt setting is limited by the settings of Insp Time and R-Rate.
The ratio of Vt to Insp Time (Vt / Insp Time) must be 3 lpm < (VOL CONTROL*60) / (Insp Time*1000)
< 100 lpm.
The product of Vt x Control R must be between the Low Min Vol + 0.5 liters and High Min Vol - 0.5 liters
(Low Min Vol + 0.5 liters
≤
Vt x Backup R / 1000
≤
High Min Vol - 0.5 liters).
Note:
The Backup R value applied depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the R-Rate value if R-Rate is greater than 8 bpm.
Warning
Ensure that the patient circuit is appropriate for the tidal volume setting (tube Ø 22 mm for adults, and
Ø 15 mm for pediatric tidal volumes lower than 200 ml) .
P Support – PRESSURE SUPPORT
P Support allows you to set a support pressure above PEEP delivered during the inspiratory phase of patient spontaneous breaths.
The sum of P Support and PEEP must not exceed 55 cmH
2
O.
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Operating Parameters
PEEP – POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the pressure level maintained during the expiratory phase.
The sum of P Support and PEEP must not exceed 55 cmH
2
O.
The ventilation mode can be adjusted without PEEP (PEEP is nearly equal to 0 cmH
2
O when set to “OFF“).
R-Rate – RESPIRATORY RATE
R-Rate is the rate at which ventilator controlled breaths are triggered, excluding apnea ventilation.
R-Rate and Vt are related so that the product of Vt x R-Rate must be between the setting limit of
Low Min Vol + 0.5 liters and High Min Vol - 0.5 liters (Low Min Vol + 0.5 liters
≤
Vt x R-Rate / 1000
≤
High Min Vol - 0.5 liters).
R-Rate and Insp Time are related so that if R-Rate is greater than 8 bpm, then Insp Time must be
0.2 x 60 / R-Rate < Insp Time < 0.8 x 60 / R-Rate.
Note:
• During apnea, ventilation, the ventilator delivers controlled breaths according to a Backup Rate (Backup R) as long as no inspiratory trigger has been detected.
• The Backup R value depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and becomes equal to the R-Rate value if R-Rate is greater than 8 bpm.
Insp Time – INSPIRATORY TIME
Insp Time allows you to determine the inspiratory phase duration of ventilator controlled breaths and is limited to a 1:2 or greater I:E ratio.
For physiological and efficiency reasons, its setting is limited by those of Vt and R-Rate.
The ratio Vt/Insp Time must be between 3 liters and 100 liters [3 < (Vt x 60) / (InspTime x 1000) < 100].
Note:
The Backup R value depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and becomes equal to the R-Rate value if R-Rate is greater than 8 bpm.
Insp Sens – INSPIRATORY TRIGGER SENSITIVITY
Insp Sens allows you to set the level of patient inspiratory effort required to initiate a machine controlled breath.
The sensitivity levels decrease from 1P to 5: the higher the index, the less sensitive the trigger sensitivity.
These levels correspond to differences in flow compared to the bias flow as shown below: fall for four (4) seconds with the following limits:
Table 3-15. Volume SIMV Inspiratory Trigger Sensitivity
Insp Sens
5
5
5
PEEP
0 to 5
6 to 10
11 to 20
Minimum Flow (LPM)
Required to Trigger*
8
9
10
4
4
4
0 to 5
6 to 10
11 to 20
7
8
9
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Operating Parameters
Table 3-15. Volume SIMV Inspiratory Trigger Sensitivity (Continued)
3
3
3
0 to 5
6 to 10
11 to 20
6
7
8
2
2
2
0 to 5
6 to 10
11 to 20
5
6
7
1P
1P
1P
0 to 5
6 to 10
11 to 20
3
4
5
*Stated minimum trigger flow may vary +10%
The flow values in the table above are indicative values given for a particular test setup and are intended to show the sensitivity variation against the PEEP and insp sens setting configurations. They are not intended to be compared to simple flow-by threshold triggering commonly used by other ventilators.
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled air (CO
2
).
The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow.
Caution
Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering. Level 1P, the most sensitive inspiratory trigger, is recommended for pediatric use. For an adult, this setting may cause ventilator autotriggering.
Apnea Time
Apnea time allows the user to monitor and detect interruptions to the patient's spontaneous breathing pattern. The ventilator declares apnea when no breath has been delivered by the time that the operatorselected apnea interval elapses. The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (60/Backup Rate setting).
Note:
• During apnea ventilation, the ventilator delivers machine controlled breaths according to a Backup Rate
(Backup R) – as long as no inspiratory trigger has been detected.
• The Backup R value applied depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the R-Rate value if R-Rate is greater than 8bpm.
I Time (Low and High)
The minimum (Low I) and maximum (High I) duration of the inspiratory phase cannot be set in V SIMV or
P SIMV mode. In both the P SIMV and V SIMV modes, the Low I Time defaults to a setting equal to RISE
TIME + 300 ms and the High I Time defaults to the lesser of 3 seconds or 30/R-Rate.
Flow Pattern
The distribution shape (or flow pattern) of the flow rate during the inspiratory phase cannot be set in
V SIMV mode. The device is configured by default with a square wave flow pattern that represents a constant flow rate ( ).
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Operating Parameters
Rise Time
The Rise Time during the inspiratory phase can be set in V SIMV mode and the range is 1-4. The ventilator has a default Rise Time of 2 (or a pressure rise time of 400 ms).
Exh Sens – Exhalation Trigger Sensitivity
Exh sens is available in the PSIMV, VSIMV, and PSV mode. In CPAP, exh sens is defaulted to 25% and is not adjustable.
Exh Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.
The end of inspiration will occur when Inspiratory Flow has decreased to the preset Exh Sens setting.
The expiratory trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.
If the flow drop is insufficient, exhalation is automatically triggered independently of the Exh Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time of three (3) seconds has elapsed, which corresponds to an I:E Ratio of 1:1.0, to ensure that the patient has enough time to exhale.
The following graph describes exhalation trigger sensitivity:
PIP (Low and High Alarm Settings) – PEAK INSPIRATORY PRESSURE
A minimum and maximum pressure alarm threshold must be set.
The Low PIP (or Low Pressure) setting determines the trigger threshold for the “LOW PRESSURE
DISCONNECT“ alarm. Refer to chapter 5, “Alarms and Troubleshooting” .
Warning
The setting of the Low PIP alarm must be adjusted for the patient, but must also be set high enough to allow the LOW PRESSURE DISCONNECT alarm to trigger properly. Perform the Low Pressure Test (refer to
section F.1, “Low Pressure Test,” on page F-1 ) to ensure the Low PIP alarm is properly set.
The High PIP or High Pressure setting determines the level of pressure which is not to be exceeded during the inspiratory phase. When this level is reached, inspiration is terminated, the device switches to
exhalation, and a “High PIP“ alarm is triggered. Refer to chapter 5, “Alarms and Troubleshooting”
.
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Operating Parameters
The difference between the Low PIP and High PIP settings is limited to a minimum of 8 cmH
2
O. Their settings are also limited by that of PEEP; thus, Low PIP must be greater than PEEP by at least 2 cmH
2
High PIP must be greater than PEEP by at least 10 cmH
2 changes in the Low PIP and/or High PIP thresholds so that these differences are always maintained.
O and
O. A change in the PEEP level may lead to automatic
VTI (Low and/or High Alarm Settings) – INSPIRATORY TIDAL VOLUME
It is possible to set a Low and/or High alarm threshold for the inspired tidal volume received by the patient.
VTI allows you to trigger an alarm during breath delivery if the tidal volume inspired by the patient is lower than the minimum threshold set (“LOW INSP VOLUME“ alarm) or greater than the maximum threshold set
(“HIGH INSP VOLUME“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
).
Low VTI and High VTI are related to Vt such that Vt must be higher than Low VTI by at least 10 ml, but lower than High VTI by at least 10 ml.
If Vt is changed, Low VTI and High VTI are, if necessary, automatically readjusted so that the difference between them is maintained.
Setting Low VTI and High VTI is not mandatory (set to “OFF“), but the display of the measured value is always active in a double limb configuration.
VTE (Low and/or High Alarm Settings) – EXPIRED TIDAL VOLUME
A double limb patient circuit configuration must be used when setting the Low and/or High Tidal volume alarm limits.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW EXH VOLUME“ alarm) or greater than the maximum threshold set (“HIGH
VTE“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
Low VTE and High VTE are linked to Vt such that Vt must be greater than Low VTE by at least 10 ml but lower than High VTE by at least 10 ml.
If Vt is changed, Low VTE and High VTE are, if necessary, automatically readjusted so that the difference between them is always maintained.
Setting Low VTE and High VTE is not mandatory (each can be set to “OFF“) , but the measured value is always displayed using a double limb patient circuit.
Min Vol (Low and/or High Alarm Settings) – MINUTE VOLUME
It is possible to set an alarm threshold for the average minimum and/or maximum Minute Volume inspired by the patient for one minute.
Min Vol allows you to trigger an alarm if the average volume received by the patient is lower than the minimum threshold set (“LOW MINUTE VOLUME“ alarm) or greater than the maximum threshold set
(“HIGH MINUTE VOLUME“ alarm). Refer to chapter 5, “Alarms and Troubleshooting”
.
Low Min Vol and High Min Vol are also related to Vt and R-Rate according to the following difference, expressed in liters, such that the product Vt x R-Rate must be higher than Low Min Vol + 0.5 liters and lower than High Min Vol - 0.5 liters (Low Min Vol + 0.5
≤
Vt x Backup R / 1000
≤
High Min Vol - 0.5 liters).
Note:
The Backup R value applied depends on the R-Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the R-Rate value if R-Rate is greater than 8 bpm.
If Vt is changed, Low Min Vol and High Min Vol are, if necessary, automatically readjusted so that the difference between them is always maintained.
Setting Low Min Vol and High Min Vol is not mandatory (set to “OFF“), but the display of the measured value is always active.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 3-25
Operating Parameters
Rtot (High Alarm Setting) – HIGH RATE
The maximum rate threshold set is used to monitor and alarm for ventilator autotriggering.
The alarm setting is used to trigger the “HIGH RATE” alarm. Refer to chapter 5, “Alarms and
.
When set, the High Rtot threshold must always exceed the Backup Rate by 5 bpm; the High Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.
Setting the High Rtot is not mandatory (it can set to “OFF”) , but the measured value is always displayed.
3.6
FIO
2
For Various Oxygen and Ventilator Settings
Inhalation flow (LPM) = Volume (L) x 60 / Inspiratory time (S)
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S ECTION
Monitored Parameters
During ventilation, ventilator parameters measured or calculated are highlighted in the menus used for setting the ventilation parameters, the alarms, and the waveforms.
In addition to the display of monitored ventilation parameters, ventilation is displayed graphically, as follows:
• Pressure bar chart, in the ventilation parameters setting menu
• Pressure and flow rate waveforms, according to time, in the graphic menu (if waveforms was selected in the preferences menu) .
Refer to chapter 7, “Operating Procedures”
.
Note:
To monitor patient Oxygen levels use an external sensor/alarm.
4.1
Digital Monitoring
The ventilation parameters monitored or calculated are highlighted in each of the main menus:
•
Ventilation menu (See Figure 4-1 )
•
•
Waveform menu (See Figure 4-3 )
Figure 4-1. Monitored Parameters in the Ventilation Menu
Monitored Parameters
Figure 4-2. Monitored Parameters in the Alarm Menu
Figure 4-3. Monitored Parameters in the Waveform Menu
Monitored parameter values are updated every two breath cycles and are displayed in the form of inserts,
(
).
1
2
3
1 Parameter name
2 Measured or calculated value
3 Unit of measure
Figure 4-4. Monitored Parameter Inserts
If the monitored value for a parameter is not applicable or available, the value is replaced by a hyphen “–”
).
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Monitored Parameters
Figure 4-5. Display Showing Unavailable Parameter Values
Inspiratory Trigger
During each inspiration phase triggered by the patient, the Inspiratory Effort Detected symbol is displayed
beside the cycling I:E ratio in the ventilation, alarm, or waveform menus (See Figure 4-6
).
The patient triggers the ventilator by inhaling the amount of flow and the ventilator responds by delivering either a pressure-based or volume-based breath.
Figure 4-6. Inspiratory Effort Detected Indicator
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 4-3
Monitored Parameters
Displayed Monitored Parameters
Table 4-1. Displayed Monitored Parameters
Monitored
Parameters Display Range
Inspiratory Tidal Volume
Exhaled Tidal Volume
Minute Volume
Peak lnspiratory
Pressure
PIP
Positive End Expiratory
Pressure
PEEP
0 to 99 cmH
2
O
0 to 99 cmH
2
O
Rate
Mean Airway Pressure
I:E Ratio
Inspiratory Time
Expiratory Time
VTI
VTE
Min V
Rtot
MAP
I:E
I Time
E Time
0 to 9995 ml
50 to 9995 ml
0 to 99.9 l
0 to 99 bpm
0 to 99 cmH
2
O
1:9.9 to 9.9:1
0 to 9.9 s
0 to 59.9 s
Description
Flow delivered by the ventilator to the patient at each inspiratory phase is measured by the inspiratory transducer and that measurement is used to calculate volume (the flow transducers do not directly measure volume).
The displayed value is updated at each inspiration.
When a Pressure Control or Pressure Support breath is delivered and a leak is present, the ventilator will increase flow to reach the pressure target. The monitored Pressure
Control or Pressure Support value reflects the amount of flow the ventilator delivers from the outlet port during inhalation. The monitored value will increase (possibly to an abnormally high number) when a leak is present. This displayed value does not represent what is delivered to the patient.
Patient exhaled flow is measured by the exhalation flow transducer and that measurement is used to calculate volume (the flow transducers do not directly measure volume).
The displayed value is updated at each inspiration, but is available only in the double limb patient circuit configuration.
Flow delivered at each breath to the patient is measured by the inspiratory transducer and that measurement is used to calculate minute volume (Vt x Rtot) (the flow transducers do not directly measure volume).
The displayed value is updated at each exhalation.
Highest circuit pressure during each inspiration phase measured with the proximal pressure sensor.
The displayed value is updated at each exhalation.
End expiratory pressure is measured by the proximal pressure sensor.
The displayed value is updated at each inspiration.
Total number of breaths measured per minute.
The displayed value is based on each breath and is updated at each inspiration.
Average patient pressure during each breath.
The displayed value is updated at each inspiration.
Ratio of inspiratory time measured to expiratory time measured.
The displayed value is updated at each inspiration.
Inspiratory time measured.
The displayed value (only in waveform menu) is updated at each exhalation.
Expiratory time measured.
The displayed value (waveform only) is updated at each inspiration.
4-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Monitored Parameters
Table 4-1. Displayed Monitored Parameters (Continued)
Monitored
Parameters Display Range
Inspiratory Minute
Volume
Expiratory Minute
Volume
Min VI
Min VE
0 to 99.9 l
0 to 99.9 l
Description
Volume delivered at each breath to the patient and converted to minute volume (Vt x Rtot).
The Min VI is measured by the inspiratory flow transducer.
The displayed value (waveform only) is updated at each exhalation.
Exhaled volume by the patient to the machine and measured by the exhalation flow transducer.
The displayed value (waveform only) is updated at each inspiration.
Available only in the double limb patient circuit configuration.
4.2
Bargraph Display
In the ventilation menu, the highlighted bargraph dynamically displays pressures established throughout the
breath cycle (See Figure 4-7 ).
1
2
Figure 4-7. Bargraph Display
, item 1) which remains displayed until the maximum value of the following cycle has been reached.
The PEEP value is represented by a line at the bottom of the bargraph (See Figure 4-7 , item 2).
4.3
Waveform Display
The waveform screen is only accessible during ventilation from the alarm parameters screen using the
MENU
key. Its display has been configured in the Preferences menu (refer to chapter 7, “Operating
• The Pressure waveform and the Flow waveform are referenced to Time. On these waveforms, the maximum Pressure and Flow lines are updated each time the graphic window is refreshed (every two breath cycles).
• The scales for Pressure and Flow automatically adjust according to the maximum levels measured over the last three cycles. The time scale also adjusts automatically according to the breath rate frequency, which allows the display of two consecutive cycles.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 4-5
Monitored Parameters
The waveform screen is shown in
1
2
3
4
1.
Ventilation Mode
2.
Pressure over last two
cycles
1
3.
Maximum Flow over
last two cycles
4.
Frozen waveform
symbol
5. Inspiratory trigger
symbol
1. Pressure and flow scales are adjusted over three cycles, but only two cycles are displayed.
5
Figure 4-8. Waveform Screen
Waveform tracing can be frozen at any time, which enables the analysis of pressure and flow waveforms, while continuing patient ventilation.
To freeze the waveform trace:
Press the DOWN key.
• The waveform display is frozen.
• The display of the last numerical monitored values remains fixed.
• The Freeze Waveform symbol is displayed in the upper part of the screen.
To unfreeze the waveform trace:
Press the UP key.
• Waveform tracing continues.
• The display of the numerical values monitored is refreshed.
• The Freeze Waveform symbol disappears.
The Freeze Waveform function remains active even when changing the ventilation or alarm menu, or stopping ventilation. Accessing the Preferences Menu or the Alarm logs screen while the Freeze Waveform function is active deactivates this function.
To dismiss the waveform screen manually:
Press the MENU key .
The waveform screen is automatically dismissed:
• When a High priority alarm is triggered.
• When you press the VENTILATION ON/OFF key to stop ventilation.
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S ECTION
Alarms and Troubleshooting
Warning
Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
The alarms or faults generated by your Puritan Bennett™ 540 Ventilator are classified into two categories:
• Ventilation (or utilization) alarms
• Technical faults
Some of the ventilator alarms are adjustable, depending on ventilation modes (refer to
chapter , “Operating Parameters”). Automatic, non-adjustable alarms also exist to create a
safety net for safe patient ventilation.
Alarms indicate events likely to affect the ventilation in the short term and necessitate rapid
intervention (refer to section 5.8, “Troubleshooting,” on page 5-13
).
Technical faults do not directly affect machine operation. Therefore, the user is not alerted to technical faults. Only authorized and trained technicians may consult the maintenance menu
(refer to the Puritan Bennett 540 Service Manual).
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
5.1
Alarm Level of Priority
The alarm hierarchy for signaling the level of alarm criticality is listed below.
• Very High Priority (VHP): Immediate critical situation; ventilation is impossible:
Continuous Sound Signaling / With or Without Continuous Red LED Illumination / With or Without Message / With or Without Display Lighting (it is possible for an alarm condition to occur that may not have both a message and lighting).
• High Priority (HP): Critical situation in the short term; ventilation is potentially compromised:
High Frequency Sound Signaling / Flashing Red LED Illumination / With Message / With
Display Lighting
Alarms and Troubleshooting
• Medium Priority (MP): Critical situation in the long term; ventilation is not affected in the short term:
Medium Frequency Sound Signaling / Flashing Yellow LED Illumination / With Message / With Display
Lighting
Note:
• There are currently no Low Priority (LP) Alarms.
• If there is no corrective action and if the audible alarm is not inhibited (Audio Paused) or reset (Alarm Reset) within 60 seconds, High Priority alarms will sound at the maximum level of 85 dB(A).
5.2
Alarm Display
During operation, when an alarm is activated:
• One of the red or yellow alarm indicators to the left of the ALARM CONTROL and flashes.
• An alarm tone sounds.
key illuminates
• A message is displayed and flashes in reverse video at the bottom of the Ventilation Menu or Alarm
Menu.
V ENTILATION M ENU
A LARM I NDICATORS
A LARM M ENU
5-2 10071604 Rev. A
A LARM M ESSAGES
Figure 5-1. Alarm Displays
Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Note:
There are currently no Low Priority (LP) Alarms.
When an alarm is triggered, if the current menu displayed is not the Ventilation parameters or Alarm menu, the display automatically switches to one of these menus to display the alarm message.
In the event several alarms are activated at the same time, the highest priority audible and visual alarm is highlighted; however, all active messages are displayed, in the sequence in which they occurred.
5.3
Alarm Logs Menu
All alarms are recorded in the internal memory of the ventilator at the time they are activated.
The Alarm Logs menu is used to display the last eight (8) alarms activated, along with their date and time of activation.
To access the Alarm Logs menu, do the following:
1. Press the MENU key to access the alarm setting menu (if this is not the menu currently displayed).
2. Press the DOWN key several times or press until the cursor is on the “Alarm Logs” line at the bottom of the page. The display appears as follows:
3. Press the ENTER key. The Alarm Logs screen is displayed.
Note:
When no alarm has been activated, “NO DATA” is displayed on the screen (see graphic below).
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-3
Alarms and Troubleshooting
To dismiss the Alarm Logs screen manually:
Press the ENTER key when the cursor is on the “Back” line.
The Alarm Logs screen is dismissed automatically:
• After 15 seconds if no keyboard action is detected
• When a High Priority alarm is triggered
Note:
Only qualified service personnel may access all alarms and events recorded by the ventilator. Qualified personnel should refer to the Puritan Bennett™ 540 Service Manual for further information.
5.4
Silencing the Audible Portion of Alarms
You may silence the audible portion of alarms for 60 seconds at a time. This is referred to as the Audio
Paused function.
To silence the audible portion of activated alarms:
Press the ALARM CONTROL key.
• The audible portion of all activated alarms is paused.
• The visual portions (light indicator and message) of activated alarms remain visible.
• The Audio Paused symbol function is active.
is displayed at the top right of the screen while the audio pause
If several alarms are activated at the same time, pressing the ALARM CONTROL current alarms.
key affects all
5-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
The audible portion of activated alarms is automatically reactivated:
• After 60 seconds, if the cause(s) of the alarm(s) persist(s)
• Whenever a new alarm is activated
Note:
If a key is stuck or held down for 45 seconds a keypad alarm will occur.
5.5
Pausing/Resetting Alarms
Warning
• Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. The audible alarm vents located at the front of the device should never be obstructed. The alarm can be paused with the Alarm Pause function by pressing the ALARM
CONTROL key twice once the alarm has been declared.
• When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
Some alarms are not automatically cancelled when the condition causing the alarm ceases; these can be paused manually even if the cause(s) of their activation remain(s).
To manually pause an alarm, proceed as follows:
Press the ALARM CONTROL key twice.
• The alarm is paused: the audible portion, light indicator, and message are all halted (for the alarms which can be paused manually).
• The Alarm Paused symbol is displayed at the top right of the Ventilation, Alarms, and
Waveforms screens. See the sample screen, below.
When no other alarms are currently activated, the last alarm cancelled is displayed continuously in the alarm message window in the Alarms menu, along with the date and time of its activation (as shown above).
.
To manually reset the High Pressure Alarm, proceed as follows:
Press the ALARM CONTROL key twice.
• The visual alarms will be reset.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-5
Alarms and Troubleshooting
5.6
Re-activating Alarms
Alarms that have been paused and whose activation conditions continue to exist can be reactivated.
To reactivate alarms, proceed as follows:
1. Press the MENU key to access the Alarm Setting menu, if this is not the menu currently displayed.
2. Press the DOWN key to position the cursor on the “Alarm Logs” line, if this is not already the case. The following graphic shows an example of the resulting display.
3. Press the ENTER key, to confirm access to the “Alarm Logs” menu.
4. Press the UP key to position the cursor on the “Reactivate Paused Alarm” line. The following graphic shows the resulting display.
5. Press the ENTER
• A “beep” sounds.
key for at least three (3) seconds. The following events occur:
• An audible alarm sounds.
• An alarm indicator illuminates.
• The messages of all active alarms are displayed in a loop in the Ventilation and Alarm menus.
• The Audio Paused symbol disappears (if it was displayed).
• The Alarm Paused symbol disappears.
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Alarms and Troubleshooting
5.7
Overview of Alarms
Note:
The message: “*IF PERSISTS RESTART/SRVC” will occur only if the alarm condition continues for longer than
30 seconds.
Table 5-1. Overview of Alarms
Alarm Message
Audio
Paused
Avail.
Alarm
Paused
Avail.
AC POWER
DISCONNECTION
APNEA
BATT FAULT1
CALL SERVICE
BATT FAULT2
CALL SERVICE
BATT FAULT3
CALL SERVICE
BATT FAULT4
RESTART/SRVC
BATT TEMP FAULT*
*IF PERSISTS
RESTART/SRVC
Cause/Ventilator Response
Cut-off of the AC (mains) power supply.
Alarm activation occurs:
• After 5 seconds if ventilation is stopped
• At the start of a ventilation cycle when ventilation is in progress.
Consequence: switch over to external DC power supply if present, otherwise to the internal battery.
No inspiratory trigger detected by the ventilator after the apnea time set in
PSV/CPAP, P SIMV and V SIMV modes.
Automatically clears itself after two successive patient breaths.
Ventilator has detected an internal battery fault.
Consequence: the internal battery is disabled from use.
No internal battery detected.
Priority
MP
MP
MP
MP
The internal battery is not recognized as a
Puritan Bennett™ battery.
Internal battery charging failure.
Consequence: charging of the internal battery impossible.
MP
MP
Battery temperature out of tolerance.
Consequence: battery charging stops.
MP
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes – except for CPAP
No
No
No
Yes
Yes
CAL FAULT
SEE USER MNL
Failure of one calibration point of the internal exhaled flow sensor.
Consequence: failed calibration point is replaced by the default point.
MP Yes Yes
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-7
Alarms and Troubleshooting
Table 5-1. Overview of Alarms (Continued)
Alarm Message
CHECK PROXIMAL
LINE1
*IF PERSISTS
RESTART/SRVC
CHECK PROXIMAL
LINE2
*IF PERSISTS
RESTART/SRVC
CHECK/CHANGE
EXH VALVE2
CHECK
SETTINGS
Cause/Ventilator Response
1. Loss of signal from the proximal pressure sensor
Consequence: switch to internal pressure sensor for the pressure measurement.
Alarm activation occurs:
• In the event of signal loss (1):
After one ventilation cycle or
In the event of signal loss(2) and after the 17 th breath cycle:
After 17 seconds for PRES A/C and VOL A/C modes, or after the maximum time between
17 seconds and Apnea Time + 4 seconds for
CPAP/PSV/ P SIMV, and V SIMV modes
Proximal pressure < 0.6 cmH during inspiration phase of 3
2 rd
O for 100 ms
breath cycle
Ventilator response: Switch to internal pressure sensor for pressure measurement.
Abnormally high expired flow during the inspiratory phase of three consecutive breaths
(in double-limb setup).
Alarm activation occurs:
After three consecutive breaths.
Alarm activation occurs:
• Systematically after software versions have changed.
• Loss of memorized parameters
Consequence:
• Locking Key disabled
• Out-of-range settings are replaced by their default values
Priority
MP
MP
MP
MP
CHK EXH VALV
RESTART VENT*
*IF PERSISTS
RESTART/SRVC
CHECK/CHANGE
EXH VALVE1*
*IF PERSISTS
RESTART/SRVC
CHK VOL/INSP TIME
SETTINGS*
*IF PERSISTS
RESTART/SRVC
• Faulty pressure valve sensor signal at ventilation start.
Inspired tidal volume during exhalation < 40% of Inspired Tidal volume and inspired tidal volume inspired tidal volume > 20mL
Measurement and calculation of tidal volume do not match Vt set during six consecutive breaths in VOL inspired and V SIMV modes.
Alarm activation occurs:
• After six consecutive breaths – once the ventilator has reached its performance limits.
Audio
Paused
Avail.
Yes
Yes
Yes
Yes
HP Yes
HP Yes
HP Yes
Alarm
Paused
Avail.
No
No
No
Yes
Yes
No
No
5-8 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-1. Overview of Alarms (Continued)
Alarm Message
DEVICE FAULT1
RESTART/SRVC
DEVICE FAULT2
RESTART/SRVC
DEVICE FAULT3
RESTART/SRVC
DEVICE FAULT4
RESTART/SRVC
DEVICE FAULT5
RESTART/SRVC
DEVICE FAULT6
RESTART/SRVC
DEVICE FAULT7
RESTART/SRVC
DEVICE FAULT8
RESTART/SRVC
DEVICE FAULT9
RESTART/SRVC
DEVICE FAULT10
RESTART/SRVC
DEVICE FAULT11
RESTART/SRVC
DEVICE FAULT12
RESTART/SRVC
DEVICE FAULT13
EMPTY BATTERY
EXHSENS FAULT OR
CRKT LEAK
HIGH DEVICE TEMP
COOL VENT*
*IF PERSISTS
RESTART/SRVC
Cause/Ventilator Response
Faulty internal pressure sensor signal.
Alarm activation occurs:
• After 15 seconds.
Faulty proximal pressure sensor signal.
Alarm activation occurs:
• After 15 seconds.
Failure in the 24 V power supply.
Ventilator cooling fan operating speed not suited to the internal ambient temperature of the device.
Detection of a fault in the electrical power supply system.
Consequence: the internal battery capacity is not displayed beside the battery symbol.
Turbine speed too low with high temperature.
Consequence: ventilation stops immediately and O
2
supply stops.
Detection of a fault in sensor voltage measurement.
Inspiratory flow is constant (± 1 lpm) with normal turbine temperature and speed conditions. Contact your service representative for assistance.
POST RAM Error. RAM Read/Write does not match memory setting.
POST FLASH Checksum Error. Startup FLASH computed checksum does not match memory setting.
POST EEPROM Error. Startup EEPROM does not match memory setting.
POST Reference Voltage Error. 5V or 10V reference voltage error.
Software Version Error
Internal battery capacity < 10 min. or 3%.
(battery voltage < 22.5V)
Consequence: ventilation comes to a halt.
At least four of the last six spontaneous breaths are terminated by time.
Priority
HP Yes
MP
HP
MP
MP
HP No
HP
HP
VHP
VHP
VHP
VHP
VHP
Audio
Paused
Avail.
No
No
HP No
MP
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
Yes
Device internal ambient temperature out of tolerance range.
MP Yes
Alarm
Paused
Avail.
No
Yes
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
Yes
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-9
Alarms and Troubleshooting
Table 5-1. Overview of Alarms (Continued)
Alarm Message
HIGH EXH
VOLUME
HIGH INSP VOLUME
HIGH MINUTE
VOLUME
HIGH PRESSURE
HIGH RATE
INVERSE I:E
RATIO
Cause/Ventilator Response
Expired tidal volume greater than High VTE set during three consecutive breaths (in double limb setup).
Alarm activation occurs:
• After three consecutive breaths.
Inspired tidal volume greater than High VTI set during three consecutive breaths in PSV/CPAP,
PRES A/C, P SIMV, and V SIMV modes.
Alarm activation occurs:
• After three consecutive breaths.
Minute volume higher than High MinVol set during three consecutive breaths.
Alarm activation occurs:
• After three consecutive breaths.
• In VOL A/C or V SIMV modes, if Inspiratory
Pressure is higher than High PIP during three consecutive cycles.
or
• In PSV/CPAP, PRES A/C, or P SIMV modes, if
Inspiratory Pressure is higher than
(P Support or P Control + PEEP) + 5 cmH
2 up to 29 cmH
2
30 cmH
2
O or + 10 cmH
2
O over
O
O during three consecutive cycles.
or
• In PSV/CPAP mode and P Support is set to off, if Inspiratory Pressure is higher than
PEEP + 10 cmH
2 cycles.
O during three consecutive
Alarm activation occurs:
• After three consecutive breaths.
Consequence:
• Switch to exhalation phase.
Rate measured greater than High Rtot set during three consecutive breaths.
Alarm activation occurs:
• After three consecutive breaths.
An Insp Time setting that results in an inspiratory time greater than the exhalation time.
Alarm activation occurs:
• Upon setting parameter values, such that the Insp Time value exceeds the limit described above.
Priority
MP
Audio
Paused
Avail.
Yes
HP Yes
MP
HP
Note:
When alarm condition becomes false, alarm priority indicator must be manually reset by pressing the
key.
MP
MP
Yes
Yes
Yes
Yes
KEYPAD FAULT CALL
SERVICE*
*IF PERSISTS
RESTART/SRVC
LOW BATTERY
Keyboard key held down for more than
45 seconds.
Internal battery capacity < 30 min. or 8%.
HP No
HP Yes
Alarm
Paused
Avail.
No
No
No
No
(The visual portion of the alarm may be paused)
No
Yes
No
No
5-10 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-1. Overview of Alarms (Continued)
Alarm Message
LOW EXH VOLUME
LOW INSP VOLUME
LOW MINUTE
VOLUME
LOW PRESSURE
DISCONNECT*
*IF PERSISTS
RESTART/SRVC
LOW SPKR/BATTERY
OCCLUSION CHECK
CIRCUIT*
*IF PERSISTS
RESTART/SRVC
ON INTERNAL
BATTERY
(with Periodic
Audible Signal)
POWER FAULT
RESTART/SRVC
Cause/Ventilator Response
Expired tidal volume less than Low VTE set during three consecutive breaths (in doublelimb setup).
Alarm activation occurs:
• After three consecutive breaths.
Inspired tidal volume less than Low VTI set during three consecutive breaths in PSV/CPAP,
PRES A/C, P SIMV and V SIMV modes.
Alarm activation occurs:
• After three consecutive breaths.
Minute volume lower than Low Min Vol set during three consecutive breaths.
Alarm activation occurs:
• After three consecutive breaths.
Flow is greater than 130 lpm during the inspiratory phase.
In VOL A/C and V SIMV modes:
If patient pressure is lower than Low PIP in
VOL A/C and V SIMV modes.
In PSV/CPAP, PRES A/C modes, and P SIMV:
If patient pressure is lower than (P Support +
PEEP) - 20% or (P Control + PEEP) - 20%
Alarm activation occurs if the above conditions remain:
• For more than 60/R-Rate in VOL AC and
PRES AC modes.
• For more than 60/R-Rate + Insp time in
VSIMV and PSIMV modes.
• For more than Apnea + 2 s in PSV / CPAP mode.
Occurs when the buzzer battery is too low to sound an alarm when ventilating using battery power. Connecting the ventilator to AC power for 15 minutes should clear the alarm.
Tidal volume measured negligible during three consecutive breaths for PSV/CPAP, PRES A/C and P SIMV modes.
Alarm activation occurs:
• After three consecutive breaths.
Cut-off of the external DC power supply.
Consequence: switch-over to the internal battery.
Detection of a fault in the electrical power supply system.
Priority
MP
MP
MP
HP
MP
HP
MP
MP
Audio
Paused
Avail.
Alarm
Paused
Avail.
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
Yes
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-11
Alarms and Troubleshooting
Table 5-1. Overview of Alarms (Continued)
Alarm Message
POWER SUPPLY LOSS
(no message)
REMOTE ALARM
FAULT
SOFTWARE VERSION
ERROR
SPKR FAULT1
RESTART/SRVC
SPKR FAULT2
RESTART/SRVC
SPKR FAULT3
RESTART/SRVC
SPKR FAULT4
RESTART/SRVC
Cause/Ventilator Response
1. Electrical power supply to the machine is interrupted with the I/O switch when ventilation is in progress or
2. Battery fully discharged when it was the only source of power to the ventilator.
Consequence: ventilation stops immediately.
Ventilation restarts immediately when the switch is pressed in case 1 (above) or after restoration of the AC or DC supply in case 2
(above).
No activation of Nurse Call when an alarm is in progress.
Detection of a wrong software version.
Defective operation of the buzzers.
Consequence: no audible tone when an alarm is activated.
Failure detected in the
Very High Priority buzzer.
Consequence: no audible alarm in case of involuntary stop of the ventilation.
Battery Charge Failure due to incorrect voltage. Contact your service representative for assistance.
Buzzer Battery Failure. The Battery Buzzer
Voltage is too low, disabling the buzzer.
Contact your service representative for assistance.
Priority
VHP
MP
NA
MP
MP
HP
MP
Audio
Paused
Avail.
Alarm
Paused
Avail.
No
Yes
NA
Yes
Yes
Yes
Yes
Yes
Yes
NA
No
Yes
No
Yes
5-12 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
5.8
Troubleshooting
Caution
• This manual tells you how to respond to ventilator alarms, but it does NOT tell you how to respond to the patient.
• To ensure proper servicing of the ventilator and reduce the possibility of physical injury, only qualified personnel should attempt to service the Puritan Bennett™ 540 Ventilator.
5.8.1 Alarms
Warning
When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
actions.
Warning
Except for replacing the internal battery and performing the recommended maintenance described in
Chapters 8 through 10 of this manual, do not try to repair or otherwise service the ventilator yourself, or modify the ventilator, its components, or accessories. Doing so might endanger the patient, cause damage to the ventilator, and/or void your warranty. Only qualified service personnel should attempt repair of the ventilator.
Note:
The ventilator screen must be unlocked before setting and parameters can be changed.
Table 5-2. Alarms and Corrective Actions
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
AC POWER
DISCONNECTION
AC (“mains”) power source cut off.
Starting with 12 – 30 VDC external power supply.
Current-limiting fuse of the device blown.
Corrective Action(s)
Cancel the alarm then check the power cord or availability of a voltage on the
AC power (“mains”) outlet.
Ensure the ventilator is not plugged into an electrical outlet controlled by a wall switch.
Alarm will sound once an hour to remind the user the internal battery is in use.
Cancel the alarm.
Replace the ventilator and call for the maintenance technician.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-13
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
AMBIENT TEMP.
ALERT
Internal ambient temperature of the device out of the tolerance ranges.
Corrective Action(s)
Caution
Ensure that you are operating the ventilator within the proper temperature
).
Put the device in a warmer environment
(if the ambient temperature is too low) or in a cooler environment (if the ambient temperature is too high). For example, ensure the ventilator is not in direct sunlight or next to an air conditioning vent.
Warning
In case of operation in a high ambient temperature, handle the ventilator with care; some portions of the device may have high surface temperatures.
Warning
In the case of high ambient temperatures, it may take a significant period of time to cool the internal temperature of the ventilator to the proper operating range. To avoid injury to the patient, ensure that the air inspired by the patient does not exceed 106 °F
(41 °C). If in doubt, replace the ventilator.
AMBIENT TEMP.
ALERT
APNEA
BATT FAULT1
CALL SERVICE
BATT FAULT2
CALL SERVICE
BATT FAULT3
CALL SERVICE
Defective internal temperature probe or any other technical anomaly.
Patient’s breathing effort less than the
Sensitivity control setting.
Patient apnea.
Defective sensors.
Battery problem that prevents it from operating.
Internal battery missing or not detected.
Internal battery not recognized as a
Puritan Bennett™ battery.
Replace the ventilator and call your customer service representative.
Ensure the patient is breathing and adjust the inspiratory setting appropriately based on patient’s respiratory needs.
Examine the patient for breathing effort and stimulate if necessary.
If patient status has changed adjust the ventilator settings based on patient’s respiratory needs.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Call your customer service representative.
5-14 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
BATT FAULT4
RESTART/SRVC
Battery charging impossible.
BATTERY TEMPERATURE
FAULT
Battery temperature out of the tolerance ranges.
Defective internal temperature probe or any other technical anomaly inside the battery.
Corrective Action(s)
Do not disconnect the ventilator from the AC power supply. Ensure that the power cable is installed according to the
instructions in chapter 6, “Installation and Assembly” , so that the power cable
cannot be involuntarily disconnected.
In the event the internal battery capacity is low, use an alternate device to ventilate the patient.
Call your customer service representative.
Caution
Ensure that ventilator is being used according to the operating instructions
found in Appendix B, “Specifications” .
If the ambient temperature is too low, place the device in a warmer environment.
If the ambient temperature is too high, place the ventilator in a cooler environment.
For example, ensure the ventilator is not in direct sunlight or next to an air conditioning vent.
The temperature fault alarm does not interfere with the operation of the ventilator.
Warning
In case of operation in a high ambient temperature, handle the ventilator with care; some portions of the device may have high surface temperatures.
Caution
If the alarm message persists, please call your service representative.
Do not attempt to charge a defective battery; such a battery cannot be charged.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-15
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
CALIBRATION FAULT
CHECK
EXH VALVE
RESTART VENT*
*IF PERSISTS
RESTART/SRVC
CHECK PROXIMAL
LINE1*
*IF PERSISTS
RESTART/SRVC
CHECK SETTINGS
CHECK/CHANGE
EXH VALVE1 *
*IF PERSISTS
RESTART/SRVC
Exhalation flow sensor did not pass all calibration points.
Incorrect circuit type selected in the
Preferences menu.
Exhalation block defective or not properly aligned.
Defective expiratory flow sensor.
Obstruction or abnormal damage of the exhalation valve.
Defective connection or defective exhalation valve tubing.
Excessive moisture in the exhalation block.
Defective inspiratory flow sensor.
No connection of the proximal pressure tube when ventilation starts.
Proximal pressure line disconnected or obstructed.
Defective proximal pressure sensor or internal leak of the machine.
Loss of memorized parameters.
Software versions have changed.
Large leakage detected on the patient circuit return limb during the inspiratory phase.
Contaminated or defective expiratory flow sensor.
Corrective Action(s)
Restart calibration.
There may be a leak in the circuit. Ensure a validated circuit is in use (refer to the
SolvIT SM Center at http://www.puritanbennett.com).
Verify the circuit selection in the
Preferences menu (Pediatric or Adult) matches the circuit in use.
Reset alarm message and ensure all connections are secure, verify circuit integrity, and verify the exhalation block is properly seated.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Clean or replace the exhalation valve and/or its control tube.
Reconnect the valve or replace the exhalation valve and/or the exhalation valve pilot pressure tube.
Switch to a heated wire circuit.
Remove moisture from exhalation block and valve.
Verify exhalation valve is seated properly.
Reduce temperature of the humidifier.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Reconnect the proximal pressure line.
Reconnect the connection line or replace it if obstructed.
Check for moisture or occlusion of the proximal line.
Reduce humidifier temperature.
Switch to a heated wire circuit.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Check and adjust the prescribed parameters, if necessary.
Replace the exhalation valve and/or its control tube.
Have a qualified technician replace the defective component(s) and call your customer service representative.
5-16 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
CHK VOL/INSP
TIMESETTINGS
*IF PERSISTS
RESTART/SRVC
DEVICE FAULT1
RESTART/SRVC
DEVICE FAULT2
RESTART/SRVC
DEVICE FAULT3
RESTART/SRVC
DEVICE FAULT4
RESTART/SRVC
DEVICE FAULT5
RESTART/SRVC
DEVICE FAULT6
RESTART/SRVC
DEVICE FAULT7
RESTART/SRVC
DEVICE FAULT8
RESTART/SRVC
DEVICE FAULT9
RESTART/SRVC
DEVICE FAULT10
RESTART/SRVC
DEVICE FAULT11
RESTART/SRVC
DEVICE FAULT12
RESTART/SRVC
DEVICE FAULT13
RESTART/SRVC
EMPTY BATTERY
Possible Reason(s) For The Alarm Event
Defective inspiratory flow sensor or internal leak of the machine.
Insp time is not long enough to deliver set VT.
Defective internal pressure sensor.
Defective proximal pressure sensor or internal leak of the machine.
24 V supply failure.
Operating speed of the cooling fan not properly adjusted for the internal ambient temperature of the device.
Internal problem in the electrical power supply.
Turbine overheated because of blockage during operation.
Internal technical problem.
Inspiratory flow is constant (± 2 lpm) with normal turbine temperature and speed conditions.
POST RAM Error. RAM Read/Write does not match memory setting.
POST FLASH Checksum Error. Startup
FLASH computed checksum does not match memory setting.
POST EEPROM Error. Startup EEPROM does not match memory setting.
POST Reference Voltage Error. 5V or 10V reference voltage error.
Incorrect software version detected.
Internal battery capacity is less than
10 min. (or 3%) – battery operation overextended.
Corrective Action(s)
Replace the defective device(s) and have a skilled technician check them.
Increase Insp time or decrease VT.
Minimize leaks and check circuit connections.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Ensure lateral and front openings are not obstructed.
Check air inlet filter.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
If patient has been disconnected, reconnect patient to reset the fault.
If persists, replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Call your customer service representative.
Reconnect the device to an AC power outlet, connect it to an external DC power source, or replace the battery.
Reminder: the internal battery can be charged only when the ventilator connected to an AC power supply.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-17
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
EXHSENS FAULT OR
CIRCUIT FAULT
HIGH EXH VOLUME
Leak in the patient circuit.
Uncuffed tracheostomy tube.
Vented mask interface.
Adjustment of the High VTE level too low.
Inappropriate patient circuit.
Expiratory flow sensor not calibrated properly.
Defective expiratory flow sensor.
Corrective Action(s)
Check and properly connect the patient circuit connections.
Minimize the leak.
Ensure O
2
connector is removed.
Reduce inspiratory time.
Increase E-Sensitivity setting.
Check tracheostomy cuff.
Use non-vented mask.
Modify the High VTE level.
Replace the patient circuit.
Ensure there is not excessive airflow near the exhalation block (such as a fan).
Calibrate the expiratory flow sensor
(refer to section 10.1, “Calibrating the
Expiratory Flow Sensor,” on page 10-1 ).
Replace the exhalation block and calibrate the expiratory flow sensor (see
section 10.1, “Calibrating the Expiratory
Flow Sensor,” on page 10-1 ). Call your
customer service representative.
Modify the High VTI level.
HIGH INSP VOLUME
HIGH MINUTE VOLUME
Adjustment of the High VTI level too low
(for PSV/CPAP, PRES A/C, PRES SIMV and
VOL SIMV modes).
Adjustment of the pressure level too high for the volume required (for
PSV/CPAP, PRES A/C, PRES SIMV and
VOL SIMV modes).
A leak in the patient circuit causing increased bias flow.
Inappropriate patient circuit.
Defective flow sensor or internal leak in the machine.
Adjustment of the High Min Vol level too low.
A leak in the patient circuit causing increased bias flow.
Inappropriate patient circuit.
Defective flow sensor or internal leak of the machine.
Modify the pressure level.
Check and properly connect the patient circuit.
Replace the patient circuit.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Modify the High Min Vol level.
Check and properly connect the patient circuit connections.
Replace the patient circuit with an appropriate one.
Have a qualified technician replace the defective component(s) and call your customer service representative.
5-18 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
Adjustment of High PIP too low (only for
VOL A/C and VOL SIMV modes).
Airway obstruction.
HIGH PRESSURE
Proximal pressure tube or patient circuit obstructed.
Coughing or other high-flow expiratory efforts.
Patient inspiratory resistance or compliance changes.
Defective internal circuits of the machine or pressure sensor.
Adjustment of the High Rtot level too low.
Adjustment of the Insp Sens level too low.
HIGH RATE
Patient hyperventilating
INVERSE
I:E RATIO
Defective inspiratory flow sensor.
Adjusted Insp Time inducing an inspiratory time higher than the expiratory time.
Corrective Action(s)
Increase the High PIP threshold.
Check patient’s trachea and clear the obstruction. If the filter is obstructed, replace the filter.
Clean the proximal pressure tube or the patient circuit or replace them.
• Silence the alarm, if necessary.
• Treat patient’s cough.
Have physician determine new ventilator settings.
Replace the ventilator and call your customer service representative.
Re-adjust High Rtot.
Adjust Insp Sens according to the patient.
Silence the alarm and call for a medical team if the symptoms persist.
Check for auto-cycling and adjust inspiratory sensitivity or manage leaks.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Decrease the adjustment threshold of
Insp Time.
If inverse ventilation is the intended patient setting, that alarm may be paused.
Warning
Ensure the Insp Time setting is compatible with the physiological requirements of the patient.
KEYPAD FAULT
CALL SERVICE
*IF PERSISTS
RESTART/SRVC
LOW BATTERY
Pressing a key for more than 45 seconds.
A key on the keyboard is stuck.
Internal battery capacity is less than
30 min. (or 8%) – battery operation overextended.
Press and release keys in the normal, prescribed manner. Do not press keys for
45 seconds or more.
Attempt to activate each key. If unsuccessful in releasing the stuck key(s), replace the device and call your customer service representative if the situation persists.
Immediately connect the ventilator to an
AC power outlet, or connect it to an external DC power source.
Reminder: the internal battery can be charged only when the ventilator is connected to an AC power supply.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-19
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
Patient circuit obstructed.
LOW EXH VOLUME
Leak in the patient circuit.
Exhalation block missing or disconnected.
Adjustment of a Low VTE threshold when the patient circuit is in a singlelimb configuration.
Corrective Action(s)
Clean, unblock, and/or properly connect the patient circuit.
Check and properly connect the patient circuit connections.
May be caused by increased resistance across exhalation filter (such as excessive moisture).
Restore or connect the exhalation block
(refer to section 6.7, “Exhalation Block,” on page 6-13
). If the exhalation block has been removed or replaced, calibrate
the expiratory flow sensor (see section
10.1, “Calibrating the Expiratory Flow
). Call your customer service representative.
Set the Low VTE alarm limit to OFF.
Warning
If exhaled volume monitoring is required, use the double-limb circuit for exhaled tidal volume or minute volume monitoring.
LOW INSP VOLUME
Inappropriate patient circuit.
Expiratory flow sensor not properly calibrated.
Defective expiratory flow sensor.
Adjustment of the Low VTE level too high.
Adjustment of the Low VTI level too high
(for PSV/CPAP, PRES A/C, PRES SIMV and
VOL SIMV modes)
Adjustment of the pressure level not enough to reach the volume required
(for PSV/CPAP, PRES A/C, PRES SIMV and
VOL SIMV modes).
Patient circuit obstructed or disconnected.
Inappropriate patient circuit.
Defective flow sensor or internal leak in the machine.
Replace the patient circuit with an appropriate one.
Calibrate the expiratory flow sensor
(refer to section 10.1, “Calibrating the
Expiratory Flow Sensor,” on page 10-1 ).
Replace the defective component(s) and calibrate the expiratory flow sensor (see
section 10.1, “Calibrating the Expiratory
Flow Sensor,” on page 10-1 ). Call your
customer service representative.
Modify the Low VTE level.
Modify the Low VTI level.
Modify the pressure level.
Clean, unblock, and/or reconnect the patient circuit.
Replace the patient circuit.
Have a qualified technician replace the defective component(s) and call your customer service representative.
5-20 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
Possible Reason(s) For The Alarm Event
Adjustment of the Low Min Vol level too high.
Inappropriate patient circuit.
LOW MINUTE VOLUME
Patient circuit obstructed or disconnected.
Defective flow sensor or internal leak of the machine.
Adjustment of Low PIP too high.
Leak or loose connection in the patient circuit.
Circuit disconnection from patient or ventilator.
LOW PRESSURE
DISCONNECT
*IF PERSISTS
RESTART/SRVC
Inspiratory flow exceeds 130 LPM.
Inappropriate patient circuit.
Defective internal circuits of the machine or pressure sensor.
OCCLUSION
CHECK CIRCUIT
*IF PERSISTS
RESTART/SRVC
Patient circuit obstructed.
12 – 30 VDC power supply cut off when there is no AC (“mains”) power supply.
ON INTERNAL BATTERY
POWER FAULT
RESTART/SRVC
Ventilator’s current-limiting fuse blown.
Internal problem in the electrical power supply.
POWER SUPPLY LOSS
(without message)
REMOTE ALARM FAULT
Electrical power supply cut off by the main switch when ventilation is in progress.
The internal battery that supplies the ventilator is entirely discharged.
Nurse Call is disconnected.
Relay control voltage problem.
Corrective Action(s)
Modify the Low Min Vol level.
Replace the patient circuit with an appropriate one.
Clean, unblock, and/or properly connect the patient circuit.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Decrease the Low PIP threshold.
Check the patient circuit connections to the ventilator; examine all connections for leakage and tightness.
Replace the patient circuit if necessary.
Manage leaks.
Adjust Apnea alarm setting.
Replace the patient circuit.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Clean, unblock, and/or properly connect the patient circuit.
Cancel the alarm then check the supply wiring and/or the effective availability of voltage on the external source.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Press the I/O switch to restore electrical power to the ventilator and allow ventilation to continue.
To stop ventilation, press the
VENTILATION ON/OFF key for three
seconds (refer to chapter 7, “Operating
).
Immediately connect the ventilator to an
AC power outlet or an external DC power source; otherwise, use an alternate device to ventilate the patient.
Connect the Nurse Call cord to the ventilator.
Call for the maintenance technician and carefully monitor the patient to detect possible alarm triggering.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-21
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Alarm Message or
Symptom
SOFTWARE VERSION
ERROR
SPKR FAULT1, SPKR
FAULT2
RESTART/SRVC
SPKR FAULT3
RESTART/SRVC
SPKR FAULT4
RESTART/SRVC
Possible Reason(s) For The Alarm Event
Incorrect software version detected.
Defective internal buzzers.
Internal technical problem that prevents the very high priority “POWER SUPPLY
LOSS” alarm from triggering.
Internal technical problem that prevents the buzzer battery from correctly charging.
Internal technical problem that prevents the battery warning buzzer from operating.
Corrective Action(s)
Call your customer service representative.
Replace the ventilator and call your customer service representative.
• Call your customer service representative.
• Ensure that the protective cover over the I/O switch located on the rear of the device is intact and functioning properly. This cover helps prevent accidental pressing of the I/O switch and stoppage of the ventilation.
• Ensure that the device is stabilized.
Replace the ventilator and call your customer service representative.
Connect ventilator to an AC power source and power on the unit for at least 15 minutes.
If persists call your customer service representative.
5.8.2 Other Problems
Table 5-3 provides other possible ventilator problems, causes, and corrective actions.
Warning
• If the device is damaged, its external housing is not correctly closed, or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
• If you cannot determine the cause of the problem, contact your equipment supplier. Do not use the ventilator until the problem has been corrected.
Note:
Speaker and battery alarms may occur when the unit is first powered on after the internal battery has been completely drained. Connect to an AC power source and recycle power.
5-22 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Alarms and Troubleshooting
Table 5-3. Additional Problems and Corrective Actions
Problems Possible Causes
No access to the waveforms
Display waveform set to NO in
Preference menu.
The screen backlight never switches off during ventilation
Alarm sound level too low or too high
Poor visibility of the displays
Backlight set to NO in Preference menu.
Adjustment of the alarm sound level is incompatible with the patient’s environment.
Contrast adjustment is incompatible with the luminosity of the environment.
Unusual display on the screen
Problem with the display unit.
Corrective Actions
Set Display waveform to YES in
Preference menu (refer to section 7.3,
).
Set Backlight to YES in Preference
).
Re-adjust sound level (refer to section
7.3, “Preferences Menu Parameters”
).
Re-adjust contrast (refer to section 7.3,
).
Call your customer service representative if the problem persists.
Caution
Do not expose the ventilator to direct radiation from the sun.
The ventilator does not operate after pressing
I/O switch
Light noise
Whistling noise or vibrations
Excessive heat emitted
Condensation inside the device
No external power source and the internal battery is completely discharged.
Turbine noise.
Filter and/or turbine silencer deteriorated.
Valve membranes damaged.
Obstruction of main or secondary air inlets of the casings.
Liquid entered the device.
Connect the ventilator to the AC power source.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Remove obstructions from all blocked ventilator air inlets and outlets.
Replace the ventilator and call your customer service representative.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 5-23
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5-24 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
S ECTION
Installation and Assembly
Warning
• The device must not be connected to anti-static tubes, conduits, or electrical conductors.
• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection.
Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a double-limb circuit is used – is recommended.
6.1
Installing the Ventilator
To install your Puritan Bennett™ 540 Ventilator correctly we recommend that you proceed in the following manner:
• Choose an area where air can circulate freely; avoid proximity to loose fabrics such as curtains.
• Avoid direct exposure to sunlight.
• Set the ventilator on a flat and stable surface so that its feet are all in contact with the surface. The ventilator may operate in any position, provided that the air inlets are not obstructed and the device cannot fall and possibly cause damage and/or personal injury.
Warning
• To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes
(main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains.
• Do not place the ventilator in a position where a child could reach it or in any position that might cause it to fall on the patient or someone else.
• Ensure that the ventilator’s immediate surroundings allow for the proper operational connection of the device without folding, pinching, or damaging any of the required cables or tubes, and that the connection of the patient circuit to the patient provides for a secure, comfortable fit.
• Do not operate the ventilator in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device.
Installation and Assembly
• If the room temperature at the device’s installed location is greater than 95 °F (35 °C), the flow supplied at the device outlet may exceed 106 °F (41 °C). This may lead to undesirable effects, such as excessive discomfort, for the patient. In this case, the device should be used with additional precautions, including installation in a cooler location.
Warning
• To reduce the risk of fire, keep matches, lighted cigarettes, and all other sources of ignition (such as flammable anesthetics and heaters) away from the ventilator and its oxygen supply and hoses.
• Even if the “INTERNAL BAT” charging indicator is off, charging of the battery may sometimes be incomplete if the ambient temperature is above 104 °F (40 °C) because of the battery’s internal heat safety device.
Caution
• The use of any accessory other than those specified by Covidien, may lead to an increase in electromagnetic emissions or a decrease in the equipment’s insulation against electromagnetic emissions.
• The Puritan Bennett™ 540 Ventilator requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations stated in
. In particular, the use of nearby mobile and portable communications equipment using radio frequencies (such as mobile telephones) or other systems exceeding the levels set in the IEC 60601-1-2 standard may affect the ventilator’s operation.
6.2
Connecting to External AC Power
Any of four power sources: AC power, 12 – 30 VDC power, Internal Battery power, or Auxiliary DC car adapter (cigarette lighter) can be used to power the ventilator. But when AC power is available, the ventilator will automatically select AC power as its operating power source.
Warning
• The power supply to which the ventilator is connected (both AC and DC) must comply with all current and applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear of the ventilator to ensure correct operation.
• Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off.
• To be held correctly, the AC power cable must be fitted into the cable holder incorporated in the battery access cover and located under the AC power socket. Refer to the following instructions.
Caution
• Connect the external electrical power source by first connecting the power cable to the ventilator and then to the external power source. Follow the reverse procedure to disconnect the device from electrical power sources.
• Ensure that the AC power cable is in perfect condition and not compressed.
• Do not leave power cables lying on the ground where they risk being stepped on and damaged.
To prevent accidental disconnection of the AC power cable, use the power cable holder (
page).
6-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Installation and Assembly
2
1
Figure 6-1. AC Power Cable Holder
To secure the AC power cable, proceed as follows:
1. Insert the power cable holder (
Figure 6-2 , item 1) into the notch of the battery cover.
1
2
Figure 6-2. Inserting the Power Cable Holder Into the Notch
2. Push the AC power cable into the power cable holder (
, item 2).
3. Connect the female end of the ventilator’s AC power cable to the AC connector on the back of the ventilator.
Figure 6-3. Power Cable Connected to the Ventilator
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 6-3
Installation and Assembly
4. Connect the male end of the AC power cable to the AC power outlet.
• The AC POWER indicator on the top left corner of the ventilator illuminates.
flashes while the battery charges and then turns off when the • The INTERNAL BAT indicator battery is fully charged.
Refer to Figure 6-4 on page 6-4.
If the AC power cable becomes disconnected or the AC power source fails, an “AC POWER
DISCONNECTION“ alarm signals an automatic switch to the external DC power source (if the DC power cable is connected) or to the ventilator’s internal battery.
One of three power indicators, located on the upper-left of the ventilator’s front panel, illuminates to signal
which of the three possible power sources are currently in use by the device (refer to Figure 6-4 ).
Note:
The only time the AC POWER and INTERNAL BAT indicators are illuminated at the same time is when the ventilator is connected to an AC supply and the battery is charging (INTERNAL BAT indicator is flashing).
Front Panel Keyboard
Figure 6-4. Power Indicators
To disconnect the AC power cable:
1. Disconnect the AC power cable from the AC power outlet.
2. Disconnect the AC power cable from the ventilator’s AC connector at the rear of the device.
3. Grasp the AC power cable at the level of the power cable holder and turn the cable counterclockwise while lifting it upwards and out of the holder.
6-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Installation and Assembly
6.3
Connecting to an External DC Power Source
Warning
• The use of the device on an external 12 – 30 VDC power source does not allow charging of its internal battery. Ensure that the internal battery is fully charged before connecting the DC power cable.
• When using a car auxiliary adapter (cigarette lighter) ensure the car has been started prior to plugging in the ventilator’s DC adapter.
Whenever AC power is unavailable, the ventilator can operate from a continuously powered external
12 – 30 VDC power source via a DC power cable (
Figure 6-5 , item 1) that connects to the ventilator’s rear
panel DC power input connector (
, item 2). The DC power cable is optional; refer to Appendix H,
a car as a power source as well. Ensure the car’s engine is started prior to connecting the ventilator.
Note:
• An alternative means of ventilation should always be available, particularly when the patient is in transit or away from wall power.
• While using the ventilator on external battery power it is vital that a qualified caregiver (capable of providing necessary corrective actions in the event of alarm conditions) is present.
• When AC power is not available use an external DC power prior to using internal battery power.
1
2
Figure 6-5. Connecting the Ventilator to an External DC Power Source
Caution
Connect the external DC power source by first connecting the power cable to the ventilator and then to the external DC source. Follow the reverse procedure to disconnect the device from the external DC power source.
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Installation and Assembly
To connect the DC power cable to the ventilator, proceed as follows:
1. Line up the red marker dot on the ventilator’s DC power connector with the marker on the DC power cable (
, item 1).
1
Align the red markers (dots and/or lines) before connecting the cable.
3
2
Push in to Connect the
DC Power Cable
Figure 6-6. Connecting the DC Power Cable to the Ventilator
2. Push the DC power cable onto the ventilator’s DC power connector ( Figure 6-6 , item 2).
• You will hear a locking “click”.
• The DC POWER indicator on the top left corner of the ventilator illuminates (see
To disconnect the DC power cable from the ventilator, slide the locking ring ( Figure 6-6
, item 3) back and pull the plug away from the ventilator’s rear panel to disengage it.
An “ON INTERNAL BATTERY“ alarm signals an automatic switch to the internal battery in case the external
DC power source fails or becomes disconnected.
6.4
Patient Circuit
Warning
• For pediatric use, ensure that the patient circuit type fits, and, in all respects, is suitable for use with a
• If exhaled volume monitoring is required (such as ventilator dependant patients), use the double-limb circuit for exhaled tidal volume or minute volume monitoring. In this configuration, the expired volume is monitored to ensure correct patient ventilation and identify any leaks or other problems in the patient circuit. Similarly, the Low VTE setting must be properly set to warn in the event of patient suffocation.
• The ventilator and patient circuit should always be placed so as not to hinder the patient's movements, prevent accidental disconnection, and to minimize the risk of patient strangulation by the circuit.
• The ventilator and patient circuit should always be placed so as to provide a secure, comfortable fit for the patient.
• The patient circuit should always be positioned to avoid hindering the patient's movements, to prevent accidental disconnection, and to minimize the risk of patient strangulation.
• The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer’s recommendations. Refer to the instructions for use supplied by the manufacturer of the patient circuit (included with the ventilator).
• Before assembling or reassembling the patient circuit – and on a daily basis – inspect the hoses and all other components to ensure that there are no cracks or leaks and that all connections are secure.
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Warning
• To ensure correct performance of the ventilator, the patient circuit used must be one of those recommended by Covidien in this manual. The connections of the outlet towards the patient and the return to the exhalation block (with a double limb circuit) must be made with a 3.6 feet (1.10 m) to
6.6 feet (2.00 m) long tube (between the ventilator and the patient). The tube must conform to applicable standards and be fitted with Ø 22 mm terminals that also conform to standards. Ensure that the length and the internal volume of the patient circuit are compatible with the patient’s tidal volume: a ringed tube Ø 22 mm for adults, and a ringed tube Ø 15 mm for pediatric patients with a tidal volume lower
• Adding accessories to the ventilator breathing circuit, such as a humidifier and water trap(s), may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory. Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration.
• Users must always possess an additional breathing circuit and valve while using the Puritan Bennett™
540 Ventilator.
6.4.1 Choosing the Patient Circuit Type
Single limb circuits are used with breathing modes where spirometry measurements are not required, and double limb circuits are used with breathing modes where spirometry is required. Be sure to choose the appropriate circuit in the menu preferences; in particular, ensure that Pediatric Circuit Yes/No is set to YES
validated circuits, visit the SolvIT
SM
Center Knowledge Base by clicking the link at http://www.puritanbennett.com.
6.4.2 Installing the Patient Circuit
The patient circuit is mounted depending on the setup of the circuit used and the accessories used.
The following procedures describe the installation of the patient circuit with a humidifier. To add other accessories, refer to the installation instructions for the specific accessories used.
To connect a single limb circuit do the following and refer to
Figure 6-7
:
1. Inspect the components of the patient circuit for any signs of damage, such as cracks (which might cause leakage). Do not use damaged components to assemble the patient circuit.
2. Install the bacteria filter (item 1) on the TO PATIENT outlet port, as shown.
3. Attach one end of the short circuit tubing (item 4) to the filter (item 1).
4. Attach the other end of the circuit tubing (item 4) to the inlet port of the humidifier (item 2).
5. Place a water trap (item 3) between the outlet port of the humidifier and the inlet of the exhalation valve (item 5).
6. Ensure the exhalation valve (item 5) is placed at the level of the patient.
7. Connect one end of the proximal pressure tubing (item 6) to the proximal pressure port on the exhalation valve (item 5) and the other end onto the ventilator patient pressure port (item 8).
8. Connect one end of the exhalation valve tubing (item 7) to the exhalation valve port on the exhalation valve (item 5) and the other end onto the ventilator exhalation valve port (item 9).
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Installation and Assembly
8
9
10
NOTE: Although shown here, the humidifier (item 2), water trap
(item 3), and tubes upstream of the single limb patient circuit are not included with the ventilator.
Contact your supplier for more information.
1
See also
5
LUNG
6
7
4
2
3
Figure 6-7. Single Limb Patient Circuit
9. To protect the exhalation port (as it will not be used in this configuration), place the cap (if provided with the breathing circuit) over the exhalation port opening (item 10).
To connect a double limb circuit, do the following and refer to Figure 6-8 :
1. Inspect the components of the patient circuit for any signs of damage, such as cracks (which might cause leakage). Do not use damaged components to assemble the patient circuit.
2. Install the bacteria filter (item 1) on the TO PATIENT outlet port.
3. Attach one end of the short circuit tubing (item 4) to the filter (item 1).
4. Attach the other end of the circuit tubing to the inlet port of the humidifier (item 2).
5. Place a water trap (item 3) between the outlet port of the humidifier and the patient wye (item 5) on the double limb circuit.
6. Place a water trap (item 3) between the patient wye and the inlet port of exhalation filter (item 5).
7. Connect one end of the small proximal pressure tubing (item 6) as close as possible to the patient at the level of the double limb patient wye circuit connection (item 5) and the other end on the ventilator patient pressure port.
Note:
When shipped, the proximal pressure tube may already be connected to the patient wye. If so, simply verify that the connection is secure and the tube shows no signs of damage, kinks, or obstructions.
8. Ensure that the water trap (item 3) on the expiratory limb of the patient circuit (item 7) is securely installed between the patient wye (item 5) and the exhalation valve (item 9).
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8
7
6
10
9
LUNG
5
See also
1
2
Installation and Assembly
NOTE: Although shown here, the humidifier (item 2), water traps
(item 3), and their connecting tubes are not included with the patient circuit or ventilator.
Contact your supplier for more information.
Contact your supplier for more information.
3
PB540_0001_A
4
Figure 6-8. Double Limb Patient Circuit
9. Place the exhalation valve (item 9) on the exhaust port.
10. Place a bacteria filter (item 10) between the exhalation valve (item 9) and the inlet port of the ventilator exhalation block (item 11).
11. Connect one end of the small exhalation valve tubing (item 8) to the exhalation valve port of the exhalation valve (item 11) and the other end onto the ventilator exhalation valve port.
shows details of the connections of the proximal pressure tube (
, item 6) and the exhalation valve tube (
Inhalation Port
Exhalation
Valve Tube
Proximal Pressure
Tube
Figure 6-9. Close-up of Exhalation Valve Tube and Proximal Pressure Tube
For both types of circuits, shown previously, you should connect the end of the proximal pressure tube as close as possible to the patient (at the mask or cannula entry, if possible) so that the ventilator can account for all load losses due to the circuit and its potential accessories. If this is not possible, it is best to modify the
LOW PRESSURE DISCONNECT triggering threshold by doing one of the following: set the high VTI alarm limit for pressure modes or set low VTE alarm limit for all ventilation modes if using a dual limb circuit.
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Installation and Assembly
Warning
In the SIMV mode we recommend using a double branch circuit and leaving the VTE Min setting active in the event that pressure losses are present on the patient circuit downstream from the proximal pressure link. This is because in such cases the “PATIENT DISCONNECTION” alarm would not be systematically activated in case of a disconnection of the circuit.
As a reminder: Ensure that the length and the internal volume of the patient circuit are compatible with the tidal volume: ringed tube Ø 22 mm for adults and ringed tube Ø 15 mm for pediatric patients with tidal volumes lower than 200 ml. Use, if necessary, a 22F-15M link on the outlet and a 15M-22M link on the expiratory block for a double limb circuit.
Warning
• When a nose mask or face mask is used in Non-Invasive Ventilation (NIV), the mask must NOT contain an expiration aperture or exhaust port (no leakage).
• The level of inspiratory resistance of the circuit and accessories (bacterial filter, humidifier, and so on) must be as low as possible. Settings – particularly the LOW PRESSURE DISCONNECT alarm, High inspired volume (High VTI), and Low inspired volume (Low VTI) settings – must be periodically adjusted according to changes in the patient circuit resistance – especially when filters are replaced.
• Resistance of the exhalation valve and accessories (water traps, filters, etc) must be as low as possible.
• The exhalation valve must allow rapid discharge of the circuit pressure. Ensure that the expiratory exhalation valve is always clean and its evacuation aperture (exhaust port) is never obstructed.
• Do not start ventilation until you ensure that the device is suitably assembled, and that there is proper clearance all around the unit. Ensure that the air inlet filter is properly installed and is not obstructed.
Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient circuit, including all hoses, is not damaged or obstructed.
• Adding accessories to the ventilator breathing circuit, such as a humidifier and water trap(s), may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory. Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration.
6.5
Filters
Warning
Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. Replace the filter as often as necessary to maintain cleanliness – even before the recommended replacement period is over (refer to
Appendix 10, “Routine Maintenance” ). This is critical particularly when the ventilator is
installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
The ventilator features two filter types:
• air inlet filter
• bacteria filter
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Air Inlet Filter
Consisting of foam and fine particle filter media and located at the rear of the ventilator, this filter cleans the air as it enters the ventilator.
Figure 6-10. Air Inlet Filter
Caution
The air inlet filter is not reusable. Do not attempt to wash, clean, or reuse the filter.
Bacteria Filter
It is highly recommended that you install a bacteria filter (see Figure 6-11
) on both single and double limb circuits. In a double limb configuration, two bacteria filters are used: one at the port labeled TO PATIENT, and the other at the port labeled FROM PATIENT.
• Connected to the TO PATIENT port:
This filter protects the ventilator from contamination by the patient (primarily, rebreathed air). Refer to
• Connected to the FROM PATIENT port:
This filter protects the internal expiratory flow sensor from the gases exhaled by the patient. Refer to
Figure 6-11. Bacteria Filter
Refer to the manufacturer’s instructions for more information about the use and maintenance of the bacteria filter(s).
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6.6
Humidifier
) adds moisture (water vapor) and warms the air in the patient circuit. It is
inserted into the patient circuit between the main outlet and the patient (refer to Figure 6-7
and
).
Warning
• During invasive ventilation, the patient’s upper airways may become dry and irritated, causing discomfort. For this reason, the use of a humidifier is strongly recommended.
• Always position any humidification device so that it is at a lower height than both the ventilator and the patient. Use water traps, if necessary, to limit water flow towards the ventilator and the patient and periodically empty these water traps.
• If a heated humidifier is used, you should always monitor the temperature of the air delivered to the patient. Air that becomes too hot may burn the patient’s airway.
• Consult with your Customer Support representative before attempting to use a heated humidifier.
• Adding accessories to the ventilator breathing circuit, such as a humidifier and water trap(s), may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory. Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration.
Figure 6-12. Humidifier
When a humidification device is used, any condensation that forms in the patient circuit is collected in the water trap. If you notice any moisture in the patient circuit, you need to replace the wet circuit components with dry ones.
Refer to the humidification device’s instruction for information on operating, cleaning, and sterilizing the humidifier.
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6.7
Exhalation Block
Warning
The exhalation block is for single use by a single patient. It may be periodically cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when the ventilator is in continuous use change it every three months.
Caution
Ensure that the exhalation block has been completely dried after it is cleaned.
The exhalation block can be easily removed from the device for inspection, cleaning, and replacement. No special tools are required. It is held in place by a single captive screw located on the bottom of the device.
To remove the exhalation block, do the following and refer to Figure 6-13
:
1. Ensure the ventilator is turned off.
2. Loosen the captive screw located on the bottom of the ventilator that secures the exhalation block
, item 1).
3. Grasp the exhalation port and slide the exhalation block to the left to remove it from its slot
, item 2).
1 2
Figure 6-13. Removing the Exhalation Block
After removal, the exhalation block can either be cleaned or, if required, replaced with a new one. For
information on cleaning, refer to section 9.3, ‘Cleaning the Exhalation Block”
.
To install either a cleaned or a new exhalation block, do the following and refer to
Figure 6-13
:
1. Slide the exhalation block into its slot.
2. Tighten the captive screw to secure the exhalation block in place.
Warning
Each time an exhalation block is installed, the expiratory flow sensor must be recalibrated before using
the ventilator. Refer to section 10.1, “Calibrating the Expiratory Flow Sensor,” on page 10-1 .
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6.8
Oxygen
Warning
The ventilator must not be used with flammable anesthetic substances.
6.8.1 Administering Oxygen
Warning
Oxygen therapy for patients with respiratory failure is a common and effective medical prescription.
However, oxygen therapy should always be used with the utmost care; too high an oxygen flow is likely to lead to serious complications for the patient.
Oxygen administered to the patient is introduced from an external source into the machine through the oxygen connector at the rear of the ventilator. It is then integrated into the total volume of delivered air.
Remove the oxygen inlet connector from the back of the ventilator when external oxygen is not in use.
The specific oxygen flow to the patient depends on the physiological characteristics of the patient and the ventilator settings.
The oxygen flow setting should be adjusted for each patient and established in relation to a calibrated oxygen monitor measurement. Since the factors that affect administered oxygen flow may change over time, you must ensure that these settings always correspond to the current oxygen therapy objectives
specified by the physician (refer to chapter 3.6, “FIO
For Various Oxygen and Ventilator Settings” ).
Note:
To monitor patient Oxygen levels use an external sensor/alarm such as a pulse oximeter.
Warning
• To avoid injury to the patient and/or possible damage to the ventilator: before using the ventilator, use a flow meter (flow regulator) to regulate the oxygen supply to specifications before connecting the ventilator to the oxygen supply.
• Ensure that the oxygen supply pressure to the machine never exceeds 7.25 psi (49.99 kPa) or a flow of
15 lpm. Refer to Table B-17 on page B-12.
• The Puritan Bennett™ 540 does not include an oxygen analyzer. Always measure the delivered oxygen with a calibrated oxygen analyzer that features a high and low concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
6.8.2 Connecting the Oxygen Supply
Warning
• Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical-grade oxygen.
• The hose connecting the ventilator to the oxygen source must be designed exclusively for use with medical-grade oxygen. Under no circumstances should the oxygen hose be modified by the user. In addition, the hose must be installed without the use of lubricants.
, item 1) for an external low pressure oxygen source is available at the rear of the ventilator. It is essential that you also use the special coupler (item 2) supplied with the ventilator to attach the external low pressure oxygen source to the connector. The connector is also fitted with a non-return airtight valve system. The non-return airtight valve system includes a stud (item 3) and a locking tab
(item 4).
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3 4
2
Figure 6-14. Rear Panel Oxygen Connector
Caution
protruding outwards.
• Inspect the oxygen coupler ( Figure 6-15
, item 2) before use to ensure it has its black O-ring attached and in good condition. Do not use an oxygen coupler with a missing, damaged, or worn O-ring.
To connect the oxygen supply system to the ventilator, proceed as follows and refer to
Figure 6-15
:
1. Inspect the oxygen supply’s connector ( Figure 6-15
, item 1) to ensure that connector’s black O-ring
(item 2) is not missing.
2. Push the oxygen supply’s oxygen connector (item 1) into the ventilator’s oxygen connector (
item 3).
• the ventilator’s oxygen connector’s locking stud (item 4) retracts.
• the ventilator’s oxygen connector’s locking tab (item 5) is released, ensuring that the oxygen connection is locked and secured in place.
2 3
1
4
5
Figure 6-15. Connecting the Oxygen Supply System
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Installation and Assembly
To disconnect the oxygen supply system from the ventilator, proceed as follows:
Note:
Ensure the oxygen source is turned off prior to placing the ventilator in Standby or turning off the ventilator.
1. Stop the oxygen flow from the oxygen supply.
2. Press the locking tab of the ventilator’s oxygen connector, as shown in
oxygen connection.
Figure 6-16. Disconnecting the Oxygen Supply System
3. Disconnect the oxygen supply’s oxygen connector by pulling it towards you.
is required before the oxygen connector can be reconnected.
Warning
• Never use the ventilator with an unregulated/unadjustable oxygen source.
• The connecting hose between the ventilator and the O
2
source must be designed for use exclusively with medical-grade oxygen. Under no circumstances should this hose be modified by the user, and it must be installed without the use of lubricants.
• Disconnect the oxygen supply’s oxygen connector from the ventilator whenever the oxygen supply is not in use or the connector is not connected to a leak-proof, external oxygen supply. Otherwise, a leak may occur and compromise the performance of the ventilator.
• In the event of an oxygen leak, immediately shut down the oxygen supply at its source and keep away from any incandescent source or other possible sources of ignition. Thoroughly air the room to bring the oxygen concentration down to normal.
• To prevent any interference with the internal sensors of the Puritan Bennett™ 540 Ventilator, do not install a humidifier upstream of the ventilator.
Caution
• The oxygen supply hose ages and degrades even when it not in use and should be replaced periodically. The expiration date of the hose is indicated on the back of the hose’s end piece.
• The oxygen supply must be shut off whenever ventilation is interrupted. Allow the ventilator to continue for a few cycles without oxygen whenever ventilation is stopped or started.
The external oxygen source must also have independent means of flow adjustment from the ventilator.
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6.9
Mounting the Ventilator on a Wheelchair
Warning
• Do not rely solely on the ventilator’s internal battery to sustain the ventilation. Always provide an alternative external power source.
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated occasionally while powered by its internal battery. Ensure that the internal battery never becomes fully discharged.
• Do not operate the ventilator in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device.
• Fluid or moisture of any kind must not be allowed to seep inside the ventilator. Particular areas of vulnerability include the air inlet filter and the cooling apertures located in the side, rear, and bottom panels of the ventilator.
• If exhaled tidal volume or exhaled minute volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must be used in order to detect leaks. In this case, both the High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation.
• To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the ventilator.
Caution
The Dual Bag accessory consists of a carrying bag that allows the Puritan Bennett™ 540 Ventilator
Ventilator to be both mounted onto a wheelchair and carried as a backpack (see
Refer to the Dual Bag’s instructions for further information.
Figure 6-17. Using the Dual Bag Accessory
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6.10 Mounting the Ventilator on the Utility Cart
Match the mounting holes (item 1) on the bottom of the Puritan Bennett™ 540 Ventilator to the mounting studs (item 2) on the top of the utility cart platform.
1
2
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6.11 Connecting the Nurse Call Cable
Connect the Nurse Call cable (
Figure 6-18 , item 1) to the Nurse Call Monitor Connector (item 2).
1
2
Figure 6-18. Connecting the Nurse Call Cable
Warning
Before using the Nurse Call system, ensure that its connections are secure and it operates properly. For more information, contact Covidien.
Caution
• To connect the Puritan Bennett™ 540 Ventilator to a nurse call device, first contact Covidien to verify device compatibility and to obtain a suitable connection cable.
• Do not use Nurse Call devices that operate based on the closure of an electrical circuit, because the devices often do not take into account possible cable disconnection or a total loss of power. Ensure that the Nurse Call device is always connected to the ventilator.
The Nurse call function provides for remote alerts of ventilator alarm conditions (for example, when the ventilator is used in an isolation room), and features the following:
• The ventilator signals an alarm using a normally open (NO) or a normally closed (NC) signal.
• A remote alarm is activated when an alarm condition occurs, unless either of the following is true:
• The audio paused function is active.
• The ventilator power switch is OFF.
• The remote alarm port is an 8-pin female connector; allowable current is 100mA at 24VDC (max).
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S ECTION
Operating Procedures
7.1
Turning On The Ventilator
Caution
After storage of the Puritan Bennett™ 540 Portable Ventilator in an atmosphere that differs significantly in temperature from where it is installed – typically, ± 68 °F (20 °C) – stabilize the device at room temperature for at least two (2) hours prior to starting it.
To turn the ventilator on, do the following:
Set the I/O switch (a covered, rocker-type switch located at the rear of the ventilator) to the
I
position, as shown in Figure 7-1 below.
NOTE: I/O switch cover not shown here.
Figure 7-1. Turning on the Ventilator
The following events occur:
• The ventilator is powered on.
• A Power On Self Test (POST) is carried out (when plugged in to an AC power source): the front panel indicators flash (except for the indicator showing the type of power supply in use, which remains lit) and the audible alarms briefly sound.
• The display’s backlight turns on.
• The PURITAN BENNETT™ logo is momentarily displayed.
Operating Procedures
• The blue VENT STDBY indicator to the right of the VENTILATION ON/OFF key illuminates, indicating the device is in standby mode.
• A Welcome Menu screen is displayed for about five (5) seconds, which includes the machine counter
and the patient counter, as shown in Figure 7-2
.
Figure 7-2. Welcome Menu Screen
Note:
• If the ventilator had been previously stopped by use of the I/O switch while ventilation was in progress, the ventilator starts directly in ventilation mode and does not show the Welcome Menu screen.
• The Alarm, Technical Fault, and Event logs are stored in non-volatile memory on the Main CPU PCB, ensuring that the information is retained when the ventilator is powered off and during power loss conditions.
To Skip the Welcome Menu Screen:
To skip the Welcome Menu screen, press the VENTILATION ON/OFF key to start ventilation immediately.
The Ventilation menu is then displayed, along with a prompt to press the VENTILATION ON/OFF key to start ventilation, as shown in the following graphic.
By default, the starting ventilation mode that follows the Welcome menu is the last one used; the settings are those that were active when the machine was last stopped. If the ventilator’s memory of the settings is faulty, a “CHECK SETTINGS” alarm is activated. If this occurs, the desired parameters should be reset and re-saved; otherwise the machine will operate on default parameter values.
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7.2
Setup Screen Parameters
7.2.1 Accessing Setup Configuration
Caution
The SETUP screen is only accessible if ventilation is stopped and the ventilator is powered on while the
ALARM CONTROL key is pressed. Refer to the following instructions.
Note:
1. Ensure the ventilator’s I/O switch is in the OFF ( O ) position.
2. Press and hold the ALARM CONTROL
ON ( I ) position. Continue holding the seconds), as shown in the following graphic.
key while simultaneously switching the I/O switch to the key until the Setup screen appears (approximately three
3. Release the ALARM CONTROL key.
7.2.2 Changing the SETUP Screen Parameters
The data handled on this screen are:
• Language
• Date
• Time
• Patient Hours
• Altitude Compensation
• Maintenance
Language
All messages and denominations are automatically displayed in the selected language, as follows:
• English (ENGLISH)
• Spanish (ESPANOL)
• French (FRANCAIS)
Date
The date is displayed in the format: MMM DD YYYY.
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Operating Procedures
Time
The time is displayed in the format: HH: MM: SS.
To change the language, date, or time, do the following:
1. Press the UP or DOWN key to position the cursor beside the parameter to be modified.
2. Press the ENTER key.
• The cursor changes to: .
• The selected parameter value flashes.
3. Press the UP or DOWN key to modify the value of the selected parameter.
4. Press the ENTER key to confirm the newly selected value.
Note:
• When a parameter contains several setup fields (such as Date and Time) press the ENTER key to move from one field to the next.
• If you do not confirm a change by pressing the ENTER key before seven (7) seconds has elapsed, the ventilator restores the setup field’s previous value.
Patient Hours
The value of this parameter is equal to the total number of hours that the patient has been ventilated.
To reset the Patient Hours counter to zero, proceed as follows:
1. Press the DOWN graphic.
key to place the cursor at the “Patient Hours“ line, as shown in the following
2. Press the ENTER key.
• The cursor is placed on the “Reset Hours line: OFF“.
3. Press the ENTER
• “OFF“ flashes.
key.
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4. Press the UP following graphic.
or DOWN
Operating Procedures
key to change the “OFF” message to “YES“, as shown in the
5. Press the ENTER key.
• “YES“ is displayed continuously.
• A long “beep“ sounds.
• The patient counter display indicates 00000h, as shown in the following graphic.
6. Press the UP or DOWN key.
• The display indicates “Reset Hours: OFF“, as shown in the following graphic.
Altitude Compensation
This feature corrects flow and delivered volume calculations when the ventilator is used at high altitudes.
Warning
The default setting for altitude compensation is YES. Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations.
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Operating Procedures
To change altitude compensation:
1. Press the DOWN key to place the cursor at the “Altitude compensation” position.
2. Press the ENTER
3. Press the UP
key.
or DOWN key to change the message to “YES” or “OFF,” as desired.
4. Press the ENTER key.
The parameters of the SETUP Screen remain in memory until they are modified.
Maintenance
This option is reserved solely for maintenance operators qualified by Covidien to ensure proper maintenance and correct operation of the device. For information on using the Maintenance option, refer to the Puritan Bennett™ 540 Ventilator Service Manual.
7.2.3 Exiting the Setup Screen
To exit the SETUP Screen, you must cycle the ventilator’s power.
1. Set the ventilator’s rear panel I/O switch to its OFF ( O ) position. Wait 30 seconds.
2. Set the ventilator’s I/O switch to its ON ( I ) position.
The ventilator will run through a Power On Self Test (POST) routine and return to Standby mode.
7.3
Preferences Menu Parameters
The Preferences menu is accessed from the Ventilation Parameters menu, when ventilation is either on or off.
Warning
Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
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7.3.1 Preferences Menu
To display the Preferences menu, do the following:
1. Press the DOWN key several times, or continue to press the DOWN on the “Preferences” line, as shown in the following graphic:
key, until the cursor is
2. Press the ENTER
Figure 7-3. Selecting the Preferences Menu
key. The Preferences menu is displayed.
To change the settings in the Preferences menu, proceed as follows:
1. Press the UP key to place the cursor on the parameter line to be modified.
2. Press the ENTER key.
• The cursor changes to the plus/minus symbol.
• The parameter selected to be modified flashes, or, for certain parameters featuring a bar graph, the indicator triangle under the bar graph becomes filled.
Refer to the following graphics.
Cursor: plus/minus symbol
Parameter value: flashing
Indicator triangle: filled
3. Press the UP or DOWN key to change the selected parameter’s value.
4. Press the ENTER key to confirm the new parameter setting.
• The new parameter setting is displayed continuously.
• The cursor returns to its initial form.
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If a parameter change is not entered before seven (7) seconds elapses, the ventilator resets the parameter to its previous value.
The adjustable parameters in this menu are:
• Pediatric Circuit
• Backlight
• Contrast
• Alarm Volume
• Key Sound
• Display Waveforms
To adjust the various Preferences menu parameters, refer to the instructions provided in this section.
To set up the ventilator for a pediatric circuit:
1. Use the UP or DOWN arrow keys to place the cursor at the “Pediatric Circuit” position.
2. Press the ENTER key.
3. Press the UP or DOWN arrow key to set the message to “YES.” Setting the ventilator to “NO” configures the device for an Adult circuit.
4. Press the ENTER key.
Note:
The default setting is “NO” (the ventilator is set for Adult use).
Machine Hours:
This counter records the total ventilation time in hours (rounded to the nearest hour) since manufacture.
Note:
The machine hour meter is reset when the CPU board is changed.
To exit manually from the Preferences menu, do the following:
• Press the ENTER key when the cursor is on the “Back to Ventilation“.
You will exit automatically from the Preferences menu when:
• No keyboard action is detected before 15 seconds elapse, or
• A High Priority alarm is triggered.
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7.3.2 Backlight
To set the Backlight, do the following:
1. Select the Backlight parameter on the display.
2. Set the backlight: a. To set the backlight to standby , select OFF .
The effect of this setting is that if no keyboard action occurs before one minute elapses, the display’s backlight fades almost to off. The display will illuminate instantly when the following occurs:
• Any one of the keys on the keyboard is pressed
• An alarm is triggered b. To set the backlight to light continuously , select YES . This setting ensures that the display is continuously lit.
3. Confirm the new Backlight setting before seven (7) seconds elapse.
The default setting for Backlight is YES (backlight lit continuously).
7.3.3 Contrast
To set the Contrast, do the following:
1. Select the Contrast parameter on the display.
2. Set the Contrast level: a. To increase the contrast, press the UP moves to the right:
key. This change is displayed visually, as the cursor
The display contrast progressively increases.
b. To decrease the contrast, press the DOWN moves to the left:
key. This change is displayed visually, as the cursor
The display contrast progressively decreases.
3. Confirm the new Contrast setting before seven (7) seconds elapse.
When ventilation is stopped, the contrast can also be changed directly from the currently displayed menu by pressing the ALARM CONTROL key continuously, while repeatedly pressing the UP or
DOWN key.
The default setting for Contrast is the medium setting (the middle of the bar graph).
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7.3.4 Alarm Volume
Warning
The sound level of the alarms should be adjusted according to the installation environment and the size of the area monitored by the patient’s caregiver. Ensure that the alarm sound apertures at the front of the device are never obstructed.
To set the Alarm Volume, do the following:
1. Select the Alarm Volume parameter on the display.
2. Set the Alarm Volume level: a. To increase the sound level of alarms, press the UP cursor moves to the right:
key. This change is displayed visually, as the
The buzzer activates and increases in sound level as the setting increases.
b. To decrease the sound level of alarms, press the as the cursor moves to the left:
DOWN key. This change is displayed visually,
The buzzer activates and decreases in sound level as the setting decreases.
3. Confirm the new Alarm Volume setting before seven (7) seconds elapse.
Current hospital standards require a minimum sound level of 55 dB(A) at a distance of 9.84
feet (three meters), which corresponds to the lowest possible volume setting. The alarm sound level range is 65 dB(A) to 85 dB(A) measured at 3.28
feet (1 meter). If a high priority alarm is not audio paused within 60 seconds of activation, the sound level automatically raises to 85 dB(A) regardless of the original setting.
The default setting for Alarm Volume is the medium level, corresponding to a sound level of 75 dB(A).
7.3.5 Key Sound
This setting is used to select the sound emitted when pressing keys on the ventilator’s keyboard.
To set Key Sound, do the following:
1. Select the Key Sound parameter on the display.
2. Select from among the following four possible options:
• OFF – No sound is emitted when a key is pressed
• Key tone – A “clock” sound is emitted when a key is pressed
• Accept tone – A “beep” sounds when the ENTER key is pressed to confirm a setting
• All tones on – A “clock” sound is emitted when all keys are pressed and a beep sounds when the
ENTER key is pressed to confirm a setting
3. Confirm the new Key Sound setting before seven (7) seconds elapse.
The default setting for Key Sound is Accept tone .
Note:
Whatever the selected Key Sound setting, pressing the VENTILATION ON/OFF key triggers a “beep” at ventilation start and a double “beep“ at ventilation stop.
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7.3.6 Display Waveforms
To set Display Waveforms, do the following:
1. Select the Display Waveforms parameter on the display.
2. Select from the following two options:
•
YES – Displays pressure and flow waveforms as a function of time (refer to section 4.3, ‘Waveform
• OFF – Results in no waveform display; hence, no waveform menu.
3. Confirm the new Display Waveforms setting before seven (7) seconds elapse.
The default setting for Display Waveforms is YES .
The waveform screen, on which the waveforms are displayed, is accessed using the MENU the Alarm Setting menu. This screen is available ONLY when ventilation is in progress.
key from
7.4
Setting the Ventilation Mode
The ventilation mode can be changed at any time from either the ventilation parameters menu or the alarm
Control Panel,” on page 7-18 , and section 7.8, “Unlocking the Control Panel,” on page 7-18 ).
Warning
In the SIMV mode the use of a double branch circuit is recommended. The VTE Min setting should remain active in the event that pressure losses are present on the patient circuit downstream from the proximal pressure link. In such cases the “PATIENT DISCONNECTION” alarm would not be systematically activated in case of a disconnection of the circuit.
Most breaths are triggered by the patient. You should carefully modify the inspiration trigger threshold in order to avoid the risk of false triggering or “autotriggering” of the ventilator. For example, Level 1P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.
7.4.1 Changing Modes While Ventilation is on Standby
To change ventilation modes while on standby:
1. Place the cursor on the first line of the menu (general information line) using the UP key.
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2. Press the ENTER key.
• The cursor changes to: .
• The mode name flashes.
3. Press the UP
4. Press the ENTER
or DOWN key until the required mode is displayed.
key to confirm the mode selected.
• The cursor returns to normal.
• The new mode is displayed with its ventilation parameters.
If the ventilation mode change is not entered before seven (7) seconds elapse, the ventilator restores the previous mode.
7.4.2 Changing Modes During Ventilation
Warning
When changing the mode during ventilation, significant transitions of pressure, flow or cycling rate might occur, depending on the difference between the modes. Before setting the new mode, first ensure that the settings between the different modes are compatible. This reduces the risk of discomfort and harm to the patient.
Changing ventilation modes during ventilation:
1. Place the cursor on the first line of the menu (general information line) using the UP key.
2. Press the ENTER key.
• The cursor changes to: .
• The mode name flashes.
3. Press the UP
4. Press the ENTER
or DOWN key until the required mode is displayed.
key to confirm the mode selected.
• The name of the new mode selected is displayed at the top left followed by the flashing “INACTIVE“ status indicator (figure below, item 1).
• The name of the mode in progress is displayed at the top right followed by the continuous
“ACTIVE“ status indicator (figure below, item 2).
• The settings for the new mode are displayed on the left (figure below, item 3) and the monitored values for the mode in progress on the right (figure below, item 4).
• The confirmation line “Accept Mode:YES“ is displayed on the bottom left (figure below, item 5).
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1
3
2
4
5
The Alarm menu screen is shown below that shows the same active and inactive mode information being displayed, along with the “Accept Mode:Yes” line, alarm parameter settings, and patient values.
5. Change the settings of the new mode, including alarms, if necessary.
6. Press the DOWN
7. Press the ENTER
key to place the cursor on the “Accept Mode:YES“ line.
key to confirm the mode change.
• The new mode selected is displayed with its settings and is applied at the beginning of the next exhalation phase if it occurs during inspiration or immediately if it occurs during exhalation.
It is not mandatory to change modes during ventilation (see steps 6 and 7, above). Thus, the settings of the next (“INACTIVE“) mode can be “prepared” while ventilation is in progress in the current (“ACTIVE”) mode. The modifications will be saved for this next mode, whether or not it is used immediately afterwards.
When setting the parameters of the future and currently inactive mode, the monitoring data for the mode in progress are displayed in the window to the right of the menu and also in the central (“Patient”) column of the table on the Alarm menu screen.
When changing the value of a parameter in this inactive mode, the monitoring data displayed in the window on the right side of the screen are temporarily hidden by the display of the value currently being changed. This is shown in the following figure, as the PEEP setting is adjusted in the inactive P SIMV mode.
If an alarm is triggered during the setting of an inactive mode, its message is displayed in the alarm message display.
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If, when the menu of an inactive mode is displayed, the keyboard is inactive for 14 seconds, the display of the active ventilation mode in use reappears on the screen and the “Accept Mode:YES“ line disappears.
The menu of the active mode can also be recalled without waiting for this delay by directly restoring the name of the mode on the general information line.
The ventilation parameters of the inactive mode and the current mode remain in memory until some or all of the parameters are modified again; this is true even after the machine is stopped.
7.5
Setting Ventilation Parameters
Ventilation parameters can be changed at anytime, as long as the Locking Key is not activated (refer to
section 7.7, “Locking the Control Panel,” on page 7-18
).
Warning
• In the case of pediatric use, ensure that the adjusted tidal volume is compatible with the needs of the child.
• An INVERSED I:E RATIO alarm is triggered when the Insp Time exceeds exhalation times. Before confirming such a setting, ensure it is compatible with the physiological requirements of the patient.
Ventilation is not interrupted by the adjustment of a value; rather, it continues according to previous settings. The new settings are applied ONLY after they are confirmed and synchronized in the next breath cycle, except for the Insp Sens setting, which is applied immediately.
To modify a ventilation parameter, do the following:
1. Place the cursor on the line of the parameter to be modified using the UP
2. Validate your intention to modify the parameters using the ENTER below.
or DOWN key.
button. Refer to the figure
• The cursor changes to: . (item 1, below)
• The parameter value flashes (item 2, below)
• A zoom of the parameter value is displayed in the right-side of the window (item 3, below).
2
1
3
Figure 7-4. Modifying a Ventilation Parameter
3. Press the UP or DOWN key to select the value desired for the parameter (continuing to press on these keys speeds up the progression of values displayed).
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4. Press the ENTER key to confirm the selected value.
• The new parameter value is displayed continuously
• The zoom disappears
• The cursor returns to normal
Note:
If a parameter change is not entered after seven (7) seconds, the ventilator restores the parameter’s previous value.
7.5.1 Setting a Ventilation Parameter Linked to Other Ventilation
Parameters
The adjustment ranges of certain parameters are limited in order to remain compatible with the levels of other previously set parameters. For additional information on the interdependence between ventilation
parameters, refer to chapter , “Operating Parameters”.
In this case, the message “Setting limited by...“ is displayed and identifies the parameter(s) that is (are) blocking the setting.
, item 1, shows that P Support cannot be set above 40; its value is limited by PEEP because their sum cannot exceed 55 cmH
2
O.
1
2
Figure 7-5. Setting Linked Parameters
Two possibilities exist in this case:
• Allow the PEEP setting to remain at 40
• Reduce PEEP below 15 so that the PEEP setting can be set higher than 40 and ensure that their sum is no greater than 55.
7.5.2 Setting a Ventilation Parameter Linked to Alarm Thresholds
Setting a ventilation parameter takes priority over an alarm threshold setting and leads to automatic readjustment of the alarm setting threshold so that the interdependence between the two remains unchanged.
Once the ventilator is in service at the patient’s home, you should use the Locking Key to block access to
changing any settings (see section 7.7, “Locking the Control Panel,” on page 7-18 ).
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7.6
Setting Alarm Parameters
Alarm parameters can be changed at any time from the Alarm menu, if the Locking Key is not enabled
).
Note:
• Adjustable alarms should not be systematically canceled; instead, they should be adjusted according to the needs and condition of the patient.
• Default alarm setting preferences should be entered prior to using the ventilator.
To modify an Alarm Parameter, do the following:
1. Ensure that the Alarm menu is displayed, showing a list of alarm parameters and columns for the low,
current, and high alarm parameter values ( Figure 7-6 on page 7-16).
2. Put the cursor next to the alarm parameter to be modified using the UP
3. Confirm your intention to modify the parameters using the ENTER key.
or DOWN key.
• The cursor changes to: (
, item 1).
• The parameter in the “Low“ column flashes (
, item 2)
• A zoom of the low parameter is displayed on the right side of the screen (
, item 3).
2
1
3
Figure 7-6. Modifying Alarm Parameters – Low Value
4. Press the UP
5. Press the ENTER
or DOWN key to modify the value of the parameter.
key to confirm the value selected .
• The new value for the “Low“ column is continuously displayed (
, item 1).
•
The value of the “High“ column flashes ( Figure 7-7 , item 2).
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•
A zoom of the high parameter value is displayed on the right side of the window ( Figure 7-7 ,
item 3).
1 2
3
Figure 7-7. Modifying Alarm Parameters – High Value
6. Press the UP
7. Press the ENTER
or DOWN key to modify the value of the parameter.
key to confirm the value selected .
• The new value is continuously displayed
• The zoom disappears
• The cursor returns to normal
If applicable, an alarm is set to “OFF“ (the alarm will not be triggered) automatically when its maximum setting limit (for the High value) or its minimum setting limit (for the Low value) is reached by successively or continuously pressing the UP or respectively.
If a parameter change is not confirmed before seven (7) seconds elapse, the ventilator restores the parameter’s previous value.
Blocking of an Alarm Threshold Linked to a Ventilation Parameter
Setting a ventilation parameter takes priority over an alarm threshold setting. Therefore, if a ventilation parameter is modified when linked to an alarm threshold, the alarm setting threshold is automatically adjusted so that the interdependences linking them are always maintained.
However, if the alarm setting threshold is modified, it cannot be changed beyond the limit of the interdependence with the ventilation parameter to which it is linked. When the alarm setting limit is reached, the message “Setting limited by...“ indicates the name of the linked ventilation parameter(s) that are limiting the parameter’s setting value.
Three possibilities exist in this case:
• The alarm parameter remains set to “OFF“.
• The alarm parameter setting is changed in relation to the value required at the start and the limits on the ventilation parameter(s) remain unchanged.
• The setting of the ventilation parameter(s) is changed to enable the alarm threshold to be set to the required value.
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Warning
• The level of inspiratory resistance of the circuit and accessories (bacteria filter, humidifier, and so on) must be as low as possible. Settings, in particular the disconnection alarm and maximum or minimum inspired volume settings, must be periodically adjusted according to changes in the patient circuit installation and particularly when installed filters are replaced.
• Adjustable alarms should not be systematically cancelled; instead, they should be adjusted according to the needs and condition of the patient.
7.7
Locking the Control Panel
When the machine is in service at a patient’s home, it is strongly recommended that you prevent accidental or unauthorized ventilator adjustments from occurring by enabling the Locking Key.
The Locking Key of your ventilator is a software function that prohibits access to the ventilation parameter settings and changes to the ventilation mode.
To enable the Locking Key, proceed as follows:
Simultaneously press the UP and the DOWN keys for at least six (6) seconds.
• The Locking Key
symbol ( Figure 7-8 , item 1) appears in the top left corner of the screen.
• Lines which are no longer accessible are preceded by a dash “–“ (
• Lines which remain operational keep their initial line access symbol.
1
2
Figure 7-8. Installing the Locking Key
7.8
Unlocking the Control Panel
To disable the Locking Key, proceed as follows.
Simultaneously press the UP and the DOWN keys for at least six (6) seconds.
• The Locking Key symbol disappears.
• The initial line access symbol is displayed in front of each line.
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7.9
Starting Ventilation
values in the Preferences menu (refer to section 7.3, “Preferences Menu Parameters,” on page 7-6 ).
Warning
• Verify the functionality of the main alarms before connecting the patient to the ventilator.
• Before starting ventilation, ensure that the device is properly assembled and that the air inlet, cooling vents, and alarm sound diffusion holes are not obstructed. Ensure also that the patient circuit is of the proper configuration (double or single limb), properly connected to the ventilator, and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies.
• You must start the ventilator and allow it to complete one full breath cycle prior to connecting the patient. Do not connect the patient before the first full breath cycle is completed.
When the ventilator is on standby (the ventilator is on, but ventilation has not started), a message that prompts the ventilator operator to press the VENTILATION ON/OFF key to start ventilation is displayed
in the right-hand window of the ventilation and alarm menus ( Figure 7-9 ).
Figure 7-9. Prompt to Start Ventilation
To start ventilation, proceed as follows:
Press and release the VENTILATION ON/OFF
• The blue light indicator, at the upper right of the VENTILATION ON/OFF key (see
item 2), turns off.
• A “beep“ sounds.
• The ventilation starts.
• The values of the monitored parameters are displayed in the right-hand window.
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1
2
Front Panel Keyboard
Figure 7-10. Starting Ventilation
7.10 Stopping Ventilation
Warning
Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.
You can stop your ventilator at any time, regardless of which menu is currently displayed.
To stop the ventilator, proceed as follows:
1. Hold down the VENTILATION ON/OFF
, item 1) for about three (3) seconds.
• A message prompting the user to keep the button pressed appears on the monitoring window, as shown in the graphic below:
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• While keeping the VENTILATION ON/OFF key pressed, a new message appears that directs the user to release the key to stop ventilation (shown in the graphic below).
• A double “beep“ sounds.
2. Release the VENTILATION ON/OFF key:
• Ventilation stops.
• The blue LED located to the upper-right of the VENTILATION ON/OFF key (
illuminates to indicate ventilation is on Standby.
•
A prompt for a new start of ventilation is displayed (see Figure 7-9 on page 7-19).
7.11 Turning Off the Ventilator
Warning
• When ventilation is in progress: if the ventilator is stopped using the I/O switch without previously stopping the ventilation, a continuous audible alarm is activated.
• When the ventilator is switched back on, it will immediately begin ventilating – without the user first having to press the VENTILATION ON/OFF key.
Set the I/O switch to the O position to power off the ventilator.
• The blue LED to the right of the VENTILATION ON/OFF key turns off.
• The ventilator screen switches off.
Note:
When the ventilator is completely stopped, but is still connected to the AC power source (the green AC POWER indicator is illuminated), the internal battery continues charging.
Warning
Handle the ventilator with care after use, particularly when room temperatures are high. Some ventilator surfaces may be very hot, even if safety specifications are not exceeded.
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S ECTION
Internal Battery
Warning
• Because the internal battery of the Puritan Bennett™ 540 Ventilator contains more than
8 grams (equivalent) lithium, it is categorized as Dangerous Goods (DG) Class 9 – even though the ventilator meets current safety standards.
The ventilator, because of this categorization, is subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA), Internal Maritime Dangerous
Goods code for sea, as well as the European Agreement concerning the International
Carriage of Dangerous Goods by Road (ADR) for Europe.
As ADR regulations cover commercial transport only, there are two groups that can be exempted from these regulations. The first group consists of private individuals, providing that the goods are for their own personal use and measures have been taken to prevent leakage. The second group consists of persons that transport the goods because they need the product to execute their job(s). For any other group or purpose, transport must be compliant with Dangerous Goods Regulations. In the case of air transport of the ventilator, whether as checked or carry-on baggage, it is recommended that the users ask the carrier which measures to take prior to transport.
• Ensure that the ventilator’s internal battery is fully charged before connecting the ventilator to an external DC power source. Powering the ventilator using an external 12–30 VDC power source (via the DC power cable) does not enable charging of its internal battery.
8.1
Battery Capacity
The reserve capacity offered by the internal battery depends on the level of adjustments made, the environmental conditions (primarily in terms of temperature,) and the physiological characteristics of the patient.
With a fully charged battery at a normal room temperature of 25 °C (± 5 °C), the ventilator can be expected to operate on internal battery power for the average durations shown in
Checking the battery charge level requires that the ventilator be running on battery power at the time of the battery check. To check the battery charge level, temporarily disconnect the ventilator from AC power (while in Stand By mode or while providing ventilation) and read the percent charge level displayed adjacent to the battery icon displayed at the top of the ventilator's display screen.
Internal Battery
Table 8-1. Internal Battery Reserve Capacity
Average Operating Time on Internal Battery Power a
Displayed Values
Vt
=
200 ml (± 5 ml)
PIP
=
10 cmH
2
O (± 2 cmH
2
Rtot
=
20 bpm
O)
Vt = 300 ml (± 5 ml)
PIP = 20 cmH
2
O (± 2 cmH
2
O)
Rtot = 15 bpm
Vt
=
500 ml (± 5 ml)
PIP
=
30 cmH
2
O (± 2 cmH
2
O)
Rtot
=
15 bpm
Vt = 750 ml (± 5 ml)
PIP = 45 cmH
2
O (± 2 cmH
2
O)
Rtot = 20 bpm
(Maximum Ventilation Parameters)
11 hours (–10%)
9 hours (–10%)
6.5 hours (–10%)
4.5 hours (–10%) a. Average durations shown are with a fully charged battery having less than 50 charge/recharge cycles.
8.2
Battery Operation
Caution
Before operating the ventilator on its internal battery, ensure that the battery is fully charged and that the charge
holds (see section 8.4, “Recharging the Battery,” on page 8-5 ).
Note:
Speaker and battery alarms may occur when the unit is first powered on after the internal battery has been completely drained. Connect to an AC power source and recycle power.
In the event of AC power interruption or disconnection of the external AC or DC power supply, the ventilator automatically switches to its internal battery and the following events occur:
• The Battery symbol is displayed at the top on the general information line.
• Battery reserve capacity is displayed on the right of the symbol.
• The “ INTERNAL BAT “ indicator at the top left of the ventilator’s front panel is continuously lit
(
).
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Figure 8-1. Internal Battery Indicator
• A loss of external supply alarm is activated.
• A “beep“ sounds every hour to remind the user that the ventilator is being powered by its internal battery.
If ventilation is stopped , the internal battery reserve capacity is displayed as a percentage of battery charge, as shown in the following graphic.
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Internal Battery
If the ventilator is running , the internal battery reserve is momentarily displayed as a percentage. Then, after the ventilator calculates the battery time remaining (which takes about two minutes, depending on the power consumption of the ventilator), the internal battery reserve is then displayed in hours and minutes
(rounded to the nearest fifteen minutes). See the following graphic.
The “LOW BATTERY“ and “EMPTY BATTERY“ alarms (refer to chapter , “Alarms and Troubleshooting”) are
triggered when the internal battery reserve is reduced.
Warning
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated occasionally while powered by its internal battery. Ensure that the internal battery never becomes fully discharged.
• When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.
From the time that an “EMPTY BATTERY“ alarm is activated, if no external supply is connected to the ventilator, other alarms may be triggered due to insufficient supply voltage.
In the final discharge phase, the “EMPTY BATTERY” alarm will become continuous, and ventilation may be interrupted at any time during this phase.
Note:
The “EMPTY BATTERY” alarm symbol may disappear shortly before the ventilator completely stops, but it always triggers a final, continuous alarm.
8.3
Testing the Battery
Your ventilator continuously and automatically checks the state of the internal battery, even when the battery is not used as the main source of energy. The “BATT FAULT1 CALL SERVICE“ alarm is activated whenever a problem is detected in the battery or the charger.
However, on a monthly basis you should disconnect the ventilator from the external power supply to check the integrity of the connections linking the internal battery to other ventilator components.
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8.4
Recharging the Battery
In the event that the battery charge level is considered insufficient, as per the reserve capacity display, recharge of the internal battery is necessary. In general, it is recommended that the ventilator be allowed to charge when the battery drops below 80%, and that the ventilator be recharged systematically after storage and before using it again.
Note:
To avoid cycling and extend battery life while connected to an AC power source, the battery will not begin charging until it has dropped below an 85%-90% charge.
To charge the internal battery, do the following:
Connect the ventilator to the AC power source.
•
The “AC POWER” indicator illuminates ( Figure 8-2 , item 1).
• The “INTERNAL BAT“ indicator flashes (
1
2
Figure 8-2. Power Indicators When Charging the Battery
When the battery charge is complete, the “INTERNAL BAT“ indicator turns off.
Warning
Even if the “INTERNAL BAT“ indicator is off, charge of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 104 °F (40 °C). This is due to the characteristics of the battery’s internal heat safety device.
Although it is not necessary to start the ventilator to charge the battery, charging the battery during operation will increase the time required to fully charge the internal battery.
When recharging a depleted internal battery, it may be necessary to leave the ventilator on charge for up to four (4) hours if the ventilator is on standby, and about 10 hours if ventilation is operating.
Warning
Using the ventilator on an external 12 –30 VDC power source does not enable charging of its internal battery.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 8-5
Internal Battery
8.5
Storing the Battery
If the device is to be stored for an extended period of time, it is not necessary to remove the battery.
However, the battery should be stored in cool, dry, well-ventilated environment, as follows:
• Temperature: approximately 70 °F (21 °C)
• Humidity: less than 80% RH
If the battery is stored for more than one month at a temperature greater than 70 °F (21 °C), or for more than one or two weeks at a temperature greater than 113 °F (45 °C), the reserve capacity of the battery may be affected. It will then be necessary to recharge the battery before using it again.
If the ventilator has been in stored for longer than 30 days connect it to an AC power source, turn the unit on, and let it charge for 15 minutes prior to use.
The battery should not be stored for more than two years, whatever the conditions.
8.6
Replacing the Battery
Warning
• When replacing the ventilator’s internal battery, the ventilator must be disconnected from all external power supplies and turned off.
• Batteries should be disposed of according to environmental legislation in your country and locality.
• Never expose any batteries to direct flame.
• Never touch the ventilator’s internal components, including the battery, and the patient simultaneously.
To replace the Battery, refer to Figure 8-3 and proceed as follows:
1. Place the ventilator on a work table.
2. Remove the three (3) screws (
, item 1) securing the battery cover with a Torx™* T10 screwdriver. These screws consist of two (2) Torx™* head screws on the rear panel and one (1) Torx™* head screw on the bottom of the ventilator, as shown – depending on the version of the device.
Torx™*
Head Screw
1
3 ea.
8-6 10071604 Rev. A
3
2
Figure 8-3. Replacing the Battery
Puritan Bennett™ 540 Ventilator Clinician’s Manual
Internal Battery
3. Slide the battery cover (
Figure 8-3 , item 2) off by pulling it towards the back of the ventilator.
4. Remove the old battery (
, item 3) from the battery cover.
5. Remove the replacement battery from its package and install it into the battery cover. Ensure that:
• You remove the protective “pull tabs” (if they are present) from the battery’s contacts.
• The battery’s contacts align with those of the ventilator, according to the drawing on the label on the back of the battery cover.
6. Place the battery cover containing the replacement battery back onto its slide rails within the ventilator.
Caution
When tightening the screws in the next step, push on the battery cover from the rear towards the front to take pressure off the cover mounting brackets; otherwise, the cover mounting brackets may break when the screws are tightened.
7. Install the three Torx™* screws (
, item 1) to secure the battery cover (
, item 2) to the ventilator and tighten the screws with the Torx™* T10 screwdriver.
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8-8 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
S ECTION
Cleaning
Warning
• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection.
Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a double-limb circuit is used – is recommended.
• To reduce the risk of infection, be sure to wash your hands thoroughly before and after handling the ventilator or its accessories.
9.1
Cleaning the Ventilator
Clean all external panels and surfaces before and after each patient use and as often as necessary to keep the ventilator clean. You should clean the ventilator periodically, whenever it is soiled or dirty, before any maintenance operation, and before storing the ventilator.
Warning
• Use all cleaning solutions and products with caution. Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator. Use only those
.
• To avoid damage to the ventilator, fluids must not be allowed to enter the device, particularly through the air inlet filter or the cooling apertures located in the side, rear, and bottom panels of the ventilator.
• The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately.
To clean the surface of the ventilator, do the following:
1. Dip a clean, soft cloth into a mixture of mild soap and water, or other approved cleaning
solution. Refer to Table 9-1 for a list of approved cleaning solutions.
2. Squeeze the cloth thoroughly to remove excess liquid.
3. Lightly wipe the external casing of the ventilator, taking care not to allow excess moisture to enter any of the openings on the ventilator’s surface. See the warning above.
4. Dry the ventilator surface with a clean, soft, lint-free cloth.
Cleaning
Table 9-1. Approved Cleaning Solutions for Exterior Ventilator Surfaces
Description Product Names
Tap water –
Saline –
70% isopropyl alcohol (rubbing alcohol)
10% chlorine bleach (90% tap water)
–
Clorox™* (or equivalent)
Hospital disinfectants
Hydrogen peroxide
15% ammonia (85% tap water)
Ammonia-based household cleaners
Household cleaners
• Professional Amphyl™*
• Cavicide™*
• Control III™*
–
–
Windex™*
Formula 409™*
9.2
Cleaning the Accessories
Follow the accessory manufacturer’s instructions for cleaning the ventilator’s accessories and components, including the patient circuit.
Warning
After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.
Caution
Never use a liquid cleaner inside the patient circuit, or on any component of a gas or air pathway.
9.3
Cleaning the Exhalation Block
Warning
• The exhalation block is for single use by a single patient . It can be cleaned with soapy water, but must NOT be disinfected or sterilized. To ensure that accurate measurements are maintained, the exhalation block must be cleaned periodically if it is used continuously.
• Ensure that the exhalation block is completely dried after cleaning and before installation and use.
The exhalation block can be removed easily from the device by first removing a captive screw, accessible
through the bottom of the device (refer to section 6.7, “Exhalation Block,” on page 6-13
).
Whenever the exhalation block is removed or after installing a new one, you must calibrate the exhalation
flow sensor. Refer to section 10.1, “Calibrating the Expiratory Flow Sensor,” on page 10-1
.
9-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
S ECTION
Routine Maintenance
Warning
• On a DAILY basis, inspect the patient circuit to ensure that it shows no signs of damage, is properly connected, and is operating correctly without leakage.
• Do not attempt to repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, and/or void your warranty. Only qualified service personnel should repair or service the ventilator.
10.1 Calibrating the Expiratory Flow Sensor
Each time the exhalation block or circuit is removed and reinstalled, or after installing a new exhalation block, the expiratory flow sensor must be recalibrated before the using the ventilator. This process is automatic and does not require the use of a measurement device.
Note:
Calibration may be done with either an adult or pediatric circuit; however, Pediatric YES/NO must be appropriately selected in the ventilator preference menu.
Routine Maintenance
To calibrate the exhalation flow sensor, refer to Figure 10-1
and proceed as follows:
1. Ensure the ventilator is on and in Standby mode.
).“
Figure 10-1. Blocking the Patient Wye (Double-Limb Circuit Shown)
3. Obstruct the patient wye’s open connector using the fleshy portion of your palm to make a good seal as shown in
key to access the alarm settings menu – if this is not the menu currently 4. Press the MENU displayed.
5. Press the UP or DOWN key to place the cursor on the VTE setup line.
6. Press the ENTER key twice to access the Patient column (central column) of the VTE setup line.
• “OFF“ flashes in the central column.
• A zoom of “OFF“ is displayed, flashing, in the window on the right.
• The message “Calibration Exp. Flow?“ is displayed in the window on the right.
10-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
7. Press the UP or DOWN key. “YES“ is displayed instead of “OFF“.
Routine Maintenance
8. Press the ENTER key to start calibration.
• The message “... Exp. calib. Processing …“ is displayed in the window on the right, while calibration is in progress.
• The ventilator adjusts the speed of the blower to reach the initial calibration point.
• A short beep sounds to confirm that the first point has been adjusted.
• The ventilator automatically increases and adjusts the speed of the blower to reach the next calibration point.
• A short beep sounds to confirm that the second calibration point has been adjusted.
• This process continues until all eight calibration points have been adjusted.
Note:
• The exhalation flow sensor calibration procedure, once initiated, must run to its conclusion.
• No message is displayed when the ventilator passes calibration; a message only is displayed if the calibration has failed.
In the event of calibration errors, the following events occur:
• The ventilator sounds a long beep at each point that fails calibration.
• An alarm is activated, and the message “CAL FAULT SEE USER MNL“ is displayed.
• The ventilator takes the previously saved value as the default and automatically switches to the next calibration point.
If a “CAL FAULT SEE USER MNL” alarm occurs perform the following:
1. Ensure the exhalation block is properly seated.
2. Ensure a validated circuit is in use (refer to the SolvIT
SM
Center at http://www.puritanbennett.com).
3. Check the integrity of the circuit and all connections.
4. Ensure the correct circuit type is selected in the ventilator preferences.
5. Repeat the calibration procedure keeping a tight seal over the end of the circuit during calibration.
For more information on the “CAL FAULT SEE USER MNL” alarm, refer to section 5.8, “Troubleshooting”
.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 10-3
Routine Maintenance
10.2 Replacing the Air Inlet Filter
Warning
Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary, replace the filter before the recommended replacement period is over. This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
Caution
• Failing to replace a dirty filter or operating the ventilator without a filter, may cause serious damage to the ventilator.
• The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.
If the ventilator is used indoors, the condition of the air inlet filter should be checked monthly. If the ventilator is used outdoors or in a dusty environment, the air inlet filter should be checked weekly and replaced as necessary.
To replace the air inlet filter, proceed as follows:
1. Hold the filter between your fingers (see
2. Remove the filter ( Figure 10-2 , item 2) and discard it.
3. Place the new filter in the device, while ensuring that: a. The fine particle side of the filter faces outwards , away from the ventilator.
b. The filter is properly installed in its housing. Proper installation of the filter prevents particles from entering the device.
1 2
Figure 10-2. Replacing the Air Inlet filter
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Routine Maintenance
10.3 Recommended Schedule of Maintenance
Consumables and Replacement Intervals
When used under normal circumstances – a relatively dust-free atmosphere, and without damage to the device and its components (shocks, cracks, significant dirt, and so on) – the intervals for replacing the ventilator’s consumable elements are as follows:
Table 10-1. Consumables and Replacement Intervals
Recommended Replacement Intervals Elements
Air Inlet Filter
(Foam + Fine Particle)
Inspiratory Bacteria Filter
Patient Circuit
Exhalation Block
Every two months or more often, depending on the extent of soiling
See manufacturer’s recommendation
See manufacturer’s recommendation
3 months (or for each new patient)
Note:
For a list of parts and accessories and their part numbers, refer to Appendix H
.
Warning
• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. Replace it when necessary – even before the recommended replacement period has elapsed, and particularly when the ventilator is installed on the wheelchair. Environmental conditions may cause the filter to become dirty more rapidly.
Failure to observe these recommendations may result in a loss of performance, excessive overheating, a loss of certain functions and, in the long term, compromise the longevity of the ventilator.
Maintenance of the Internal Battery
The internal battery does not need to be removed to verify its correct operation.
Periodic Test of the Internal Battery
Your ventilator continuously and automatically checks the state of the internal battery, even when the internal battery is not used as the main power source.
However, the battery charge status should be checked MONTHLY by disconnecting the ventilator from
external power supplies (refer to section 8.2, “Battery Operation” ). Such a test is
imperative after opening the ventilator or after a prolonged period of non-use (one month or more), in order to ensure the correct operation of internal connections linking the battery to other components.
Caution
Do not store the internal battery, either installed within or removed from the ventilator, for more than two (2) years. Storage here is taken to mean a period of continuous non-use.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A 10-5
Routine Maintenance
Replacement of the Internal Battery
The internal battery should be replaced when the battery capacity drops below 3450 mAh. Keep in mind that, for environmental protection, the ventilator and its components – including its internal battery – cannot be disposed of with household waste. You must submit the ventilator and its components for suitable selective collection and possible recycling and observe all applicable regulations.
Note:
As the total number of battery charge/discharge cycles approaches 300, a drop in potential of as much as 20% may be detected.
10.4 Service Assistance
Warning
• If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER. If necessary, remove the patient from the ventilator and provide an alternative means of ventilation.
• Do not attempt to repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, and/or void your warranty. Only qualified service personnel should repair or service the ventilator.
cannot determine the cause of the problem, contact your equipment supplier or Covdien.
Corporate Address:
Covidien
15 Hampshire Street
Mansfield, MA 02048
USA
Technical Service Phone Numbers:
Troubleshooting your portable ventilator: 1-800-255-6774
Servicing your portable ventilator: 1-800-255-6774
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S ECTION
Patient/Caregiver Checklist
What the Patient and Caregiver Must Understand
Table A-1 presents a summary of the topics that patients and caregivers must understand in
order to use the ventilator successfully. Some topics may not apply to some patients, while other patients may require additional information.
The Clinician’s Responsibility
It is the responsibility of the clinician or clinical educator to ensure that both the patient and the caregiver fully understand the topics listed below.
Table A-1. Patient/Caregiver Checklist
List of Topics
Need for ventilation.
Intended use of the ventilator.
The principles of operation for the ventilator.
Supplies required for ventilation, and their sources.
Schedule for ventilation.
How and why to monitor the patient’s condition.
The importance of coordinating care for the patient.
Resources for respite care.
Choices about future care.
The purpose of advanced directives.
How to check the patient’s vital signs.
The significance of the patient’s ease of breathing.
References
Clinician
Chapter , “Ventilator Overview”
Appendix C, “Theory of Operation”
Clinician; Appendix G, “Unpacking and
Clinician
Clinician
Clinician
Clinician
Clinician
Clinician
Clinician
Clinician
Patient/Caregiver Checklist
Table A-1. Patient/Caregiver Checklist (Continued)
List of Topics References
What to note about the patient’s skin, mucus membranes, and secretions, and their significance.
Clinician
How to recognize the signs of infection, and how to respond.
Clinician
Whom to contact for medical emergencies, equipment emergencies, or power emergencies.
Clinician; Section 10.4, “Service
Equipment and phone numbers to have available in cases of emergency.
How to contact other resources for assistance (health aides, attendants, therapists, and so on).
The importance of routine medical appointments and medical testing.
Clinician
Clinician
Power sources for the ventilator and how to connect them.
Section 6.2, “Connecting to External AC
and section 6.3, “Connecting to an External DC Power Source”
The meaning of keys and buttons.
The meaning of symbols and markings.
How to connect the patient to the ventilator via the patient breathing circuit.
The parts and purpose of the breathing circuit.
Section 1.4, “Symbols and Markings”
Section 6.4, “Patient Circuit”
Chapter , “Installation and Assembly”
How to install the humidifier.
How and when to inspect, clean, and replace the patient circuit.
How to recognize and respond to problems with the breathing circuit.
The parts and purpose of the nasal interface or mask.
Care of the nasal interface or mask.
How to recognize and respond to problems with the nasal interface or mask.
How to perform alarms tests, and how to respond if the alarms tests fail.
Chapter , “Safety Information”; Chapter
Clinician or manufacturer’s instructions for use.
Clinician or manufacturer’s instructions for use.
Clinician or manufacturer’s instructions for use.
;
How to change the Exhalation Block.
Replacement interval for outlet filters (per the filter manufacturer’s instructions).
Setting ventilation parameters and the importance of each.
Ventilator alarm settings; understanding the purpose and function of each.
Section 6.7, “Exhalation Block”
Section 10.3, “Recommended Schedule of Maintenance”
Section , “Operating Parameters”
Section 5.7, “Overview of Alarms”
A-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Patient/Caregiver Checklist
Table A-1. Patient/Caregiver Checklist (Continued)
List of Topics
Recognizing alarm priority level.
What to do in case of ventilator alarms and problems.
What to do if the ventilator alarms inappropriately.
The oxygen setting, and why it is required.
How to connect the oxygen source to the ventilator.
How to determine the quantity of oxygen being delivered, and how to adjust the quantity.
Safety rules for the use of oxygen.
How to recognize and respond to problems with the oxygen supply.
How to respond to dyspnea.
Techniques to prevent aspiration of vomit.
References
Section 5.1, “Alarm Level of Priority”
Section 5.8, “Troubleshooting”
Section 5.8, “Troubleshooting”
Clinician
Clinician; section 6.8, “Oxygen”
Clinician; section 6.8, “Oxygen”
Chapter , “Safety Information”;
Clinician
Clinician
Clinician
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A A-3
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A-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
S ECTION
Specifications
B.1
Physical
Table B-1. Physical Description (Excluding Accessories)
Ventilator Weight
Ventilator Dimensions
Connectors
9.9 lb. (4.5 kg)
9.25 in wide x 12.40 in deep x 6.0 in high
(235 mm wide x 315 mm deep x 154 mm high)
Inspiratory limb connector: ISO 22 mm (OD) conical
Expiratory limb connector (on expiratory block): ISO 22 mm (ID) conical
Oxygen inlet: Female Connector with valve
2000 ml Device airway volume
Breathing circuit volume
• Adult, dual limb
• Pediatric, dual limb
• Adult, single limb
• Pediatric, single limb
Air Inlet Filter
Inspiratory Bacteria
Filter Requirement
1150 ml
670 ml
550 ml
300 ml
Dimensions: 70 mm long x 60 mm wide
Composition: Polypropylene fiber electrostatic filter material, which is laminated onto polyurethane open-celled foam.
Efficiency: 99.54% at 24 lpm (filtering microbes 2.5 μm to 3 μm)
Maximum allowable flow resistance: 4 cmH
2
O at 60 lpm
B.2
Electrical
Table B-2. AC Electrical Supply
Voltage
100 VAC to 240 VAC
(for 240 VAC operation contact your Technical
Services representative)
12 VDC
30 VDC
Frequency
50 Hz / 60 Hz
NA
NA
Consumption
180 VA max.
8.3 A
3.3 A
Specifications
Table B-3. Internal Lithium Ion Battery
Voltage
Full-load capacity
Ampere-hour rating
25.2 VDC
4.8 Ah
On standby: 1.5 Ah
During ventilation: 0.5 Ah
Charging current
• Standby mode
• Ventilation mode
1.5 A/hr. (duration: < 6 hr.)
0.5 A/hr. (duration: < 13 hr.)
Average operating time at 25 °C (± 5 ºC) with a fully charged battery (having less than
50 charge/discharge cycles) at the following displayed values:
Vt = 200 ml (± 5 ml), PIP = 10 cmH
2
O (± 2 cmH
2
O), Rtot = 20 bpm
Vt = 300 ml (± 5 ml), PIP = 20 cmH
2
O (± 2 cmH
2
O), Rtot = 15 bpm
Vt = 500 ml (± 5 ml), PIP = 30 cmH
2
O (± 2 cmH
2
O), Rtot = 15 bpm
Vt = 750 ml (± 5 ml), PIP = 45 cmH
2
O (± 2 cmH
2
O), Rtot = 20 bpm
(maximum settings)
11 hr. (–10%)
9 hr. (–10%)
6.5 hr. (–10%)
4.5 hr. (–10%)
Table B-4. Remote Alarm
Remote Alarm Port:
Also known as the Nurse’s Call port, it provides for remote alerts of ventilator alarm conditions.
An example of a setting that requires such a feature is when the ventilator is used in an isolation room.
The ventilator signals an alarm using a normally open (NO) or a normally closed
(NC) signal.
A remote alarm is activated when an alarm condition occurs, unless either of the following is true:
• Audio paused function is active
• Ventilator power switch is turned off
The remote alarm port is an 8-pin female connector. Allowable current is 100 mA at
24 VDC (maximum).
4
2
3
1
5
7
6
8
Nurse call pin-out (view from back of ventilator)
5
6
7
8
Pin
1
2
3
4
Signal relay common normally closed (NC) normally open (NO) remote supply -
(not used)
RX Signal (not used)
TX Signal (not used) remote supply +
(not used) not used
Wire color black orange brown
B-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
B.3
Indicators and Alarms
Table B-5. Power Indicators
Ventilation ON/OFF
• Blue in standby mode
• Not lit if ventilation is in progress.
AC power
Green
DC power
Green
Table B-6. Alarm Indicators
High Priority
Red flashing LED
Medium Priority
Yellow flashing LED
Table B-7. Audio Alarms
Audio Paused
60 s ± 1 s
Alarm Volume
65 to 85 dBA ± 10% at 1 meter
B.4
Performance
B.4.1 Specifications
Table B-8. Performance Parameter Specifications and Tolerances
INTERNAL BAT
• Flashing if the battery charge is in progress.
• Continuously lit if the ventilator is powered by the internal battery.
Specifications
Volume
Pressure
Time
Rate
Inspiratory Sensitivity
Exhalation Sensitivity
50 to 2000 ml
5 to 55 cmH
2
O
0.3 to 6.0 s
1 to 60 bpm
1P to 5
5 to 95%
B.4.2 Test Results
Table B-9. Volume Performance Test Results
R-Rate (bpm)
Insp Time
(s)
C50 R5
VTI min. (ml)
VTI max. (ml)
C20 R20
C10 R50
C3 R50
VTI min. (ml)
VTI max. (ml)
VTI min. (ml)
VTI max. (ml)
VTI min. (ml)
VTI max. (ml)
5
4.0
220
2000
NA
NA
NA
NA
NA
NA
10
2.0
110
2000
110
1000
NA
NA
NA
NA
± (10 ml + 10%)
± (1 cmH
2
O ± 10%)
± 10%
± 1 bpm
N/A
N/A
15
1.3
80
1750
80
900
80
400
NA
NA
20
1.0
60
1200
60
700
60
350
60
170
30
0.7
60
700
60
400
60
250
60
140
40
0.5
NA
NA
NA
NA
60
90
60
90
50
0.4
NA
NA
NA
NA
NA
NA
60
70
60
0.3
NA
NA
NA
NA
NA
NA
NA
NA
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-3
Specifications
Note:
“NA” in
indicates data not applicable to the patient groups tested (represented by designators “C” and
“R”).
B.5
Monitored Parameters
Table B-10. Monitored Parameter Specifications and Tolerances
Ventilator Parameters
Peak Inspiratory Pressure (PIP)
Positive End Expiratory Pressure (PEEP) a
Inspiratory Tidal Volume (VTI)
Expiratory Tidal Volume (VTE)
Total Breath Rate (Rtot)
Mean Airway Pressure (MAP)
I:E Ratio (I:E)
Inspiratory Time (I Time)
Expiratory Time (E Time)
Inspiratory Minute Volume (Min VI)
Expiratory Minute Volume (Min VE)
Range
0 to 140 cmH
2
O
0 to 99 cmH
2
O
0 to 9995 ml
0 to 9995 ml
0 to 99 bpm
0 to 99 cmH
2
O
1:9.9 to 9.9:1
0 to 59.9 s
0 to 59.9 s
0 to 99.9 l
0 to 99.9 l
Tolerances
± (0.2 cmH
2
O + 8%)
± (0.2 cmH
2
O + 8%)
± (10 ml + 10%VTI)*Rate
± (10 ml + 10%VTE)*VTE
± 1 bpm
± (0.4 cmH
2
O + 8%)
± 50 ms or 10%, whichever is greater
± 50 ms or 10%, whichever is greater
± 50 ms or 10%, whichever is greater
± (10 ml + 10%)
± (20 ml + 20%) in CPAP mode above 200ml a. The PB 540 does not have the capability to reduce pressure below the PEEP pressure during the expiratory phase.
B-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
B.6
Range, Resolution, and Accuracy
lists the ranges, resolutions, and accuracies for ventilator settings, alarm settings, and patient data.
Table B-11. Ventilator Range, Resolution, and Accuracy
Setting or Monitored Parameter
Ventilator Settings
Tidal volume (Vt)
Range, Resolution, and Accuracy
Pressure control
(P Control)
Pressure support
(P Support)
Inspiratory time (Insp Time)
Respiratory rate (R-Rate)
Inspiratory sensitivity (Insp Sens)
Exhalation sensitivity (Exh Sens)
Mode
Flow Pattern (flow pattern)
Range: 50 mL to 2000 mL
Resolution: 10 mL
Accuracy: ± (10 ml + 10%) of setting
Default value: 500 mL
Depends on: Insp time, R-Rate
Range: 5 cmH
2
O to 55 cmH
2
O
Resolution: 1 cmH
2
O
Accuracy: ± (1 cmH
2
O + 10%) of P Control + PEEP setting
Default value: 15 cmH
2
O
Range: OFF or 5 cmH
2
O to 55 cmH
2
O
Resolution: 1 cmH
2
O
Accuracy: ± (1 cmH
2
O + 10%) of P Support + PEEP setting
Default value: 15 cmH
2
O
Range: 0.3 s to 6.0 s for VOL A/C and PRES A/C
0.3 s to 4.0 s for V SIMV and P SIMV
Resolution: 0.1 s
Accuracy: ± 10%
Default value: 1.5 s
Depends on: R-Rate, Vt
Range: 5 bpm to 60 bpm in VOL A/C and PRES A/C modes
1 bpm to 40 bpm in P SIMV and V SIMV modes
Resolution: 1 bpm
Accuracy: ± 1 bpm
Default value: 13
Depends on: High Rtot, Insp Time, Vt
Range: 1P-5
Resolution: 1
Accuracy: NA
Default value: 2
Range: 5% to 95% of peak flow
Resolution: 5%
Accuracy: ± (4 lpm +10%) of target exhalation flow based on
Exh Sens
Default value: 25%
In CPAP Exh Sens is fixed at 25% and is not adjustable.
Range: VOL A/C, PRES A/C, V SIMV, P SIMV, PSV/CPAP
Resolution: N/A
Accuracy: N/A
Default value: PRES A/C
Range: Square, descending ramp
Resolution: N/A
Default value: Square, descending ramp
In V SIMV, flow pattern is set to square and is not adjustable
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-5
Specifications
Table B-11. Ventilator Range, Resolution, and Accuracy (Continued)
Setting or Monitored Parameter
Ventilator Settings (Cont’d)
PEEP
Range, Resolution, and Accuracy
Rise time
Backup Rate
Apnea time
Range: OFF (0.5 cmH
2
O) to 20 cmH
2
O
Resolution: 1 cmH
2
O
Accuracy: ± (1 cm H
2
O + 10%) cmH
2
O
Default value: OFF
Range: 1-4
Resolution: 1
Default value: 2
Depends on: Insp time
Range: 5-40 bpm
Resolution: 1 bpm
Default value: 13
Depends on: Min Insp. time
In P SIMV and V SIMV, Backup Rate = Max (8, R-Rate)
Range: AUTO or 1-60 s
Resolution: 1 s
Default value: AUTO
Depends on: Backup R
In PSV, Apnea time: AUTO = 60/Backup R s, or
Apnea time: AUTO = 30 s
In V SIMV or P SIMV, Apnea Time: AUTO = 12
Alarm settings (based on breath mode)
Pressure A/C Mode
Low Inspired Tidal Volume
(Low VTI)
High Inspired Tidal Volume
(High VTI)
Low Exhaled Tidal Volume
(Low VTE)
High Exhaled Tidal Volume
(High VTE)
Low Minute Volume
(Low Min Vol)
High Minute Volume
(High Min Vol)
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: 300
Depends on: High VTI
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 2000 mL
Depends on: Low VTI
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: 300
Depends on: High VTE
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 1000
Depends on: Low VTE
Range: 0.5 L to 50.0 L
Resolution: 0.1 L
Default value: 4.0
Depends on: High Min vol
Range: 2.0 L to 99.0 L
Resolution: 0.1 L
Default value: 13
Depends on: Low Min vol
B-6 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
Table B-11. Ventilator Range, Resolution, and Accuracy (Continued)
Setting or Monitored Parameter
Pressure A/C Mode (Cont’d)
High Respiratory Rate
(High Rtot)
Range, Resolution, and Accuracy
Low Peak Inspiratory Pressure
(Low PIP)
High Peak Inspiratory Pressure
(High PIP)
PSV/CPAP Mode
Low inspired tidal volume
(Low VTI)
Range: 10 bpm to 70 bpm
Resolution: 1 bpm
Default value: OFF
Depends on: R-Rate
Range: PIP- 20% (not adjustable)
Resolution: N/A
Range: PIP+ 20% (not adjustable)
Resolution: N/A
High inspired tidal volume
(High VTI)
Low exhaled tidal volume
(Low VTE)
High exhaled tidal volume
(High VTE)
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: OFF
Depends on: High VTI
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 2000 mL
Depends on: Low VTI
Range: 30 mL to 2000 mL
Resolution: 10 mL
Default value: OFF
Depends on: High VTE
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: OFF
Depends on: Low VTE
Low Minute Volume
(Low Min Vol)
High Minute Volume
(High Min Vol)
High respiratory rate
(High Rtot)
Minimum inspiratory time
(Low I time)
Maximum inspiratory time
(High I time)
Range: 0.5 L to 50.0 L
Resolution: 0.5 L
Default value: OFF
Depends on: High Min vol, VTI, R-Rate
Range: 2.0 L to 99.0 L
Resolution: 0.5 L
Default value: OFF
Depends on: Low Min vol, VTI, R-Rate
Range: 10 bpm to 70 bpm
Resolution: 1 bpm
Default value: OFF
Depends on: Backup R
Range: 0.1 to 3 s
Resolution: 0.1 s
Default value: AUTO (Rise time + 300 ms)
Depends on: High I time, Backup R, Rise time
Range: 0.8 to 3 s
Resolution: 0.1 s
Default value: AUTO {Min [3 s; (30/R-Rate)]}
Depends on: Low I time, R-Rate
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-7
Specifications
Table B-11. Ventilator Range, Resolution, and Accuracy (Continued)
Setting or Monitored Parameter
PSV/CPAP Mode (Cont’d)
Low Peak Inspiratory Pressure
(Low PIP)
High Peak Inspiratory Pressure
(High PIP)
V SIMV Mode
Low PIP
Range, Resolution, and Accuracy
Range: PIP – 20% (not adjustable)
Resolution: N/A
Range: PIP + 20% (not adjustable)
Resolution: N/A
High PIP
Low Inspired Tidal Volume
(Low VTI)
High Inspired Tidal Volume
(High VTI)
Low Exhaled Tidal Volume
(Low VTE)
High Exhaled Tidal Volume
(High VTE)
Low Minute Volume
(Low min. vol)
High Minute Volume
(High min. vol)
High Respiratory Rate
(High Rtot)
Range: 2 cmH
2
O to 52 cmH
2
O
Resolution: 1 cmH
2
O
Default value: 2 cmH
2
O
Depends on: PEEP, P support, High PIP
Range: 12 cmH
2
O to 60 cmH
2
O
Resolution: 1 cmH
2
O
Default value: 40 cmH
2
O
Depends on: PEEP, P support, Low PIP
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: OFF
Depends on: Vt, High VTI
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 2000 mL
Depends on: Vt, Low VTI
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: OFF
Depends on: Vt, High VTE
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: OFF
Depends on: Vt, Low VTE
Range: 0.5 L to 50 L
Resolution: 0.5 L
Default value: OFF
Depends on: Vt, R-Rate, High Min vol
Range: 2 L to 99 L
Resolution: 0.5 L
Default value: OFF
Depends on: Vt, R-Rate, Low Min vol
Range: 10 bpm to 70 bpm
Resolution: 1 bpm
Default value: OFF
Depends on: R-Rate
Range: RISE TIME + 300 ms (not adjustable) Minimum inspiratory time
(Low I time)
Maximum inspiratory time
(High I time)
Range: Min [3s; (30/R-Rate)] (not adjustable)
B-8 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
Table B-11. Ventilator Range, Resolution, and Accuracy (Continued)
Setting or Monitored Parameter
P SIMV Mode
Low Inspired Tidal Volume
(Low VTI)
Range, Resolution, and Accuracy
High Inspired Tidal Volume
(High VTI)
Range: 30 mL to 2000 mL
Resolution: 10 mL
Default value: OFF
Depends on: High VTI
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 2000 mL
Depends on: Low VTI
Low Exhaled Tidal Volume
(Low VTE)
High Exhaled Tidal Volume
(High VTE)
Low Minute Volume
(Low Min Vol)
High Minute Volume
(High Min Vol)
High Respiratory Rate
(High Rtot)
Low Peak Inspiratory Pressure
(Low PIP)
High Peak Inspiratory Pressure
(High PIP)
Minimum inspiratory time
(Low I time)
Maximum inspiratory time
(High I time)
Volume A/C Mode
Low PIP
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: OFF
Depends on: High VTE
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: OFF
Depends on: Low VTE
Range: 0.5 L to 50 L
Resolution: 0.5 L
Default value: OFF
Depends on: High Min vol
Range: 2 L to 99 L
Resolution: 0.5 L
Default value: OFF
Depends on: Low Min vol
Range: 10 bpm to 70 bpm
Resolution: 1 bpm
Default value: OFF
Depends on: R-Rate
Range: PIP- 20% (not adjustable)
Resolution: N/A
Range: PIP+ 20% (not adjustable)
Resolution: N/A
Range: RISE TIME + 300 ms (not adjustable)
Range: Min [3 s; (30/R-Rate)] (not adjustable)
High PIP
Range: 2 cmH
2
O to 52 cmH
2
O
Resolution: 1 cmH
2
O
Default value: 2 cmH
2
O
Depends on: PEEP, High PIP
Range: 12 cmH
2
O to 60 cmH
2
O
Resolution: 1 cmH
2
O
Default value: 40 cmH
2
O
Depends on: PEEP, Low PIP
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-9
Specifications
Table B-11. Ventilator Range, Resolution, and Accuracy (Continued)
Setting or Monitored Parameter
Volume A/C Mode (Cont’d)
Low Exhaled Tidal Volume
(Low VTE)
Range, Resolution, and Accuracy
High Exhaled Tidal Volume
(High VTE)
Low Minute Volume
(Low Min Vol)
High Minute Volume
(High Min Vol)
High Respiratory Rate
(High Rtot)
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: OFF
Depends on: Vt, High VTE
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: OFF
Depends on: Vt, Low VTE
Range: 0.5 L to 50 L
Resolution: 0.5 L
Default value: OFF
Depends on: Vt, R-Rate, High Min vol
Range: 2 L to 99 L
Resolution: 0.5 L
Default value: OFF
Depends on: Vt, R-Rate, Low Min vol
Range: 10 bpm to 70 bpm
Resolution: 1 bpm
Default value: OFF
Depends on: R-Rate
Monitored Patient Data
Peak inspiratory pressure (PIP)
Positive end expiratory pressure (PEEP)
Inspiratory tidal volume (VTI)
Expiratory tidal volume (VTE)
Inspiratory minute volume (Min VI)
Expiratory minute volume (Min VE)
Total respiratory rate (R tot)
Mean airway pressure (MAP)
Range: 0 cmH
2
O to 99 cmH
2
O
Resolution: 1 cmH
2
O
Accuracy: ± (0.2 cmH
2
O+ 8%)
Range: 0 cmH
2
O to 99 cmH
2
O
Resolution: 1 cmH
2
O
Accuracy: ± (0.2 cmH
2
O + 8%)
Range: 0 mL to 9,995 mL
Resolution: 5 mL
Accuracy: ± (10 ml + 10%)
Range: 50 mL to 9,995 mL
Resolution: 5 mL
Accuracy: ± (10 ml + 10%) for volumes > 50 ml
A “—” symbol is displayed for volumes below 50 ml
Range: 0 L to 99.9 L
Resolution: 0.1 L
Accuracy: ± 20%
Range: 0 L to 99.9 L
Resolution: 0.1 L
Accuracy: ± 20%
Range: 0 bpm to 99 bpm
Resolution: 1 bpm
Accuracy: ± 1 bpm
Range: 0 cmH
2
O to 99 cmH
2
O
Resolution: 1
Accuracy: ± (0.2 cmH
2
O + 8%)
B-10 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
Table B-11. Ventilator Range, Resolution, and Accuracy (Continued)
Setting or Monitored Parameter
Monitored Patient Data (Cont’d)
I:E ratio (I:E)
Range, Resolution, and Accuracy
Inspiratory time (I time)
Expiratory time (E time)
Range: 9.9:1 to 1:9.9
Resolution: 0.1
Accuracy: ± 50 ms or 10% whichever is greater
Range: 0 s to 59.9 s
Resolution: 0.1 s
Accuracy: ± 50 ms or 5%, whichever is greater
Range: 0 s to 59.9 s
Resolution: 0.1 s
Accuracy: ± 50 ms or 10%, whichever is greater
B.7
Environmental
The following environmental conditions shall be observed:
Table B-12. Environmental Conditions for Storage or Transport
Temperature
-40 °F to +158 °F
(-40 °C to +70 °C)
Humidity
10% to 95% RH
Atmospheric pressure
7.2 psi to 15.4 psi
(50 kPa to 106 kPa)
Altitude
-500 ft to 13,000 ft
(-152 m to 3964 m)
Table B-13. Environmental Conditions for Operation
Temperature
+41 °F to 104 °F
(+5 °C to 40 °C)
Humidity
10% to 95% RH
Atmospheric pressure
8.7 psi to 16.0 psi
(60 kPa to 110 kPa)
Altitude
-500 ft to 13,000 ft
(-152 m to 3964 m)
Under extreme conditions of use that are beyond the recommendations above but within the limits of a supply voltage of –20%, compared to the nominal temperature or the combination of a temperature of
113 °F (45 °C) and humidity of 75% RH, the ventilator should not malfunction nor endanger the user.
However, operating the device for prolonged periods or repeatedly under such extreme conditions could result in premature aging of components and more frequent maintenance.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-11
Specifications
B.8
Pneumatic
Table B-14. Airway Resistances
Inspiratory
1.0 cmH
2
O at 30 lpm flow
3.7 cmH
2
O at 60 lpm flow
Expiratory
0.5 cmH
2
O at 30 lpm
1.1 cmH
2
O at 60 lpm
Table B-15. Patient Circuit Resistances a
Adult Double Limb
≤ 2 cmH
2
O at 60 lpm flow b
Pediatric Double Limb
≤ 2 cmH
2
O at 30 lpm flow a. Includes exhalation valve b. Values obtained from the manufacturer’s directions for use.
Table B-16. Air Inlet Resistance (Filter)
0.057 cmH
2
O (5.6 pascals) a
at 24 lpm flow a. All testing conducted on 3-inch diameter test piece
Table B-17. Oxygen Inlet Specifications
Maximum pressure
7 psi (50 kPa)
Maximum flow
15 lpm
Table B-18. Performance Specifications
Working pressure Sound pressure level
5 cmH
2
O –
55 cmH
2
O
30 dBA (per NF EN
ISO 17510-1 test conditions)
Maximum pressure limit
61.2 cmH
2
O
(60 mbar)
Internal compliance
(ventilator)
Inspiratory triggering response time (Ttr)
.0001 l/cm H
2 ms
B-12 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
B.9
Manufacturer’s Declaration
The following tables,
, contain the manufacturer’s declarations for the ventilator’s electromagnetic emissions, electromagnetic immunity, and recommended separation distances between the ventilator and portable and mobile RF communications equipment, as well as a list of compliant cables.
Warning
• Portable and mobile RF communications equipment can affect the performance of the Puritan Bennett™
540. Install and use this device according to the information contained in this manual.
• The ventilator should not be used adjacent to or stacked with other equipment, except as specified in this manual. If adjacent or stacked use is necessary, the ventilator should be observed to verify normal operation in the configurations in which it will be used.
Table B-19. Electromagnetic Emissions
The Puritan Bennett 540 is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment.
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
Complies
The ventilator uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The ventilator is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-13
Specifications
Table B-20. Electromagnetic Immunity
The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should ensure that it is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
IEC 60601 Test Level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV lines/lines
± 2 kV lines/earth
< 5% U
T
(> 95% dip in U
T
for 0.5 cycle)
40% U
T
(60% dip in U
T
for 5 cycles)
70% U
T
(30% dip in U
T
for 25 cycles)
Compliance Level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV lines/lines
± 2 kV lines/earth
< 5% U
T
(> 95% dip in U
T
for 0.5 cycle)
40% U
T
(60% dip in U
T
for 5 cycles)
70% U
T
(30% dip in U
T
for 25 cycles)
Electromagnetic
Environment–Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
AC power (“mains”) quality should be that of a typical commercial or hospital environment.
AC power (“mains”) power quality should be that of a typical commercial or hospital environment.
AC power (“mains”) power quality should be that of a typical commercial or hospital environment. If the user of the ventilator requires continued operation during power mains interruptions, it is recommended that the ventilator be powered from an uninterruptible power supply or a battery.
< 5% U
T
(> 95% dip in U
T
for 5 s)
3 A/m
< 5% U
T
(> 95% dip in U
T
for 5 s)
3 A/m Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note:
U
T
is the AC mains voltage prior to application of the test level.
B-14 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
Table B-21. Electromagnetic Immunity – Conducted and Radiated RF
The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment.
Immunity Test IEC 60601-1-2 Test Level Compliance Level
Electromagnetic Environment–
Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the ventilator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz outside
ISM bands a
3 Vrms
150 kHz to 80 MHz outside
ISM bands
Recommended separation distance d = 0.35 P
10 Vrms inside ISM bands a
10 Vrms inside ISM bands d = 1.2 P
Radiated RF
IEC 61000-4-3 d = 1.2 P 80 MHz to 800 MHz
20 V/m (per Draft Reviewer
Guidance for Ventilators,
July 1995)
80 MHz to 1.0 GHz
10 V/m
1.0 GHz to 2.5 GHz
20 V/m (per Draft Reviewer
Guidance for Ventilators,
July 1995)
80 MHz to 1.0 GHz
10 V/m
1.0 GHz to 2.5 GHz d = 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) b
.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey c
, should be less than the compliance level in each frequency range d
.
Interference may occur in the vicinity of equipment marked with the following symbol:
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-15
Specifications
Table B-21. Electromagnetic Immunity – Conducted and Radiated RF (Continued)
Note:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a b c d
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to
27.283 MHz; and 40.66 MHz to 40.70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ventilator is used exceeds the applicable RF compliance level above, the Puritan Bennett™ 540 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Puritan Bennett 540.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Table B-22. Recommended Separation Distances
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ventilator as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Transmitter (W)
150 kHz to 80 MHz
(outside ISM bands) d = 0.35 P
Separation Distance According to Frequency of Transmitter
150 kHz to 80 MHz
(in ISM bands) d = 1.2 P
80 MHz to 800 MHz d = 1.2 P
800 MHz to 2.5 GHz d = 2.3 P
0.01
0.1
1
10
0.035 m
0.11 m
.35 m
1.1 m
0.12 m
0.38 m
1.2 m
3.8 m
0.12 m
0.38 m
1.2 m
3.8 m
0.23 m
0.73 m
2.3 m
7.3 m
100 3.5 m 12 m 12 m 23 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
• An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Table B-23. Compliant Cables and Accessories
Cable or Accessory
AC power cable, North America (part no. 2971999)
Nurse call cable (part no. 3829800)
12V DC cables (3824600)
Maximum length
5.9 ft (1.8 m)
16.4 ft (5 m)
B-16 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Specifications
Warning
The use of accessories and cables other than those specified, with the exception of parts sold by
Covidien as replacements for internal components, may result in increased emissions or decreased immunity of the ventilator.
B.10 Standards Compliance and IEC Classification
General Standards
• Medical Electrical Equipment: General Requirements for Safety IEC60601-1 1990 and all its amends up to 1995.
• The ventilator will be constructed to comply with the following product Classifications as detailed in
Clause 5 of 60601-1:
• Class II Equipment
• Internally Powered Equipment
• Type BF Applied Parts
• IP31 with respect with respect to access to hazardous parts and ingress of moisture
• Not suitable for use in the presence of flammable anesthetic mixtures
• Not suitable for sterilization
• Suitable for continuous operation
• Detachable power supply cord
• Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment - Part 1:
General Requirements for Safety.
• UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety June 30, 2003.
Collateral Standards
• Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard
Electro-Magnetic Compatibility requirements and tests IEC 60601-1-2 2007.
• Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard:
Programmable Electrical Medical Systems IEC 60601-1-4 2000.
• Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard:
Usability IEC 60601-1-6 2006.
• General Requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8 2004.
Particular Standards
• Lung Ventilators for Medical Use- Particular Requirements for Basic Safety and Essential Performance
Part 2: Home Care Ventilators for Ventilator-Dependent Patient ISO10651-2 2004.
• Standard Specification for Ventilators Intended for Use in Critical Care ASTM F 1100 1997.
• Standard Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive Pressure
Ventilators and Ventilation Circuits ASTM F 1246 1991 (reapproved 2005).
• Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets ISO 5356-1.
Part 1 re-issued in 2004.
• Anaesthetic and Respiratory Equipment - Compatibility with Oxygen ISO 15001 2003.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A B-17
Specifications
FDA Guidances
• Reviewer Guidance for Premarket Notification Submissions, November 1993.
• Draft Reviewer Guidance for Ventilators, July 1995.
B-18 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
S ECTION
Theory of Operation
C.1
Architecture
The Puritan Bennett™ 540 Ventilator’s gas delivery system is primarily composed of an airflow generator and a three-way valve to control the patient circuit exhalation valve. The flow generator is a low-inertia, micro-turbine driven by a brushless DC electric motor, while the three-way valve is a proportional solenoid valve.
These two actuators are microprocessor-controlled and perform according to specific control algorithms. The microprocessor control circuit receives its data from the various servocontrolled pressure and feedback flow sensors that are built into the ventilator.
An electrical supply management system performs the energy conversions necessary for operation and switching between the available power sources and the regulated load of the internal battery.
A cooling fan helps maintain the proper operating temperature range for the internal environment of the ventilator. This fan is servo-controlled to maintain the proper temperature for the most heat-sensitive of the ventilator’s components.
C.2
Operation
The operation of the device is based on a self-adapting, closed loop drive system. The speed of the flow generator (turbine) is servo-controlled according to the patient pressure signal or the inspired flow signal.
The turbine speed control algorithms themselves are based on equations that vary according to the ventilation modes, settings, and the respiratory cycle phases. Thus, fixing the pressure rise time or flow pattern has an influence on the level of turbine acceleration at the start of the inspiration phase. The transition between the inspiration phase and expiration phase is controlled by a deceleration or braking algorithm proportional to the pressure difference between the two phases.
The expiratory solenoid valve (three-way valve) is fully closed during the inspiratory phase and is proportionally controlled during the expiratory phase to obtain the bias flow. The speed of the turbine adapts to the expiratory pressure threshold during the entire expiratory phase to maintain the operator-set PEEP.
The flow measurement completes the system by enabling detection of patient inspiratory effort and the triggering of inspiration phases. The flow measurement can also be used to determine the end of the inspiration phase in certain ventilation modes.
Theory of Operation
The flow measurement is automatically corrected as a function of the atmospheric pressure measured inside the ventilator with the Altitude Compensation feature
1
. The flow and volume are in Body Temperature
Pressure Saturated (BTPS) conditions. This necessitates that periodic inspections for calibrating the sensors be performed by maintenance technicians authorized by Covidien (refer to the Puritan Bennett™ 540
Ventilator Service Manual).
If the Altitude Compensation feature is active, a corrective algorithm is applied to the inspiration and exhalation flow for volume calculation and the flow set point in volume breath.
The sensor measurement range is software limited from 600 to 1100 hpa.
A cooling fan is provided to maintain the internal temperature of the ventilator within specified limits and to help ensure proper performance and longevity of the device.
Finally, the various measurement signals used in control and detection are protected and specifically filtered in order to limit any risk of disturbance to the device and possible problem.
Figure C-1 for an illustration of the ventilator’s gas delivery system.
O
2
Solenoi d
Nurse Call Cable
USB Cable (Intl only)
SpO
2
Cable (Intl only)
P C P ort Cable
Insp
Flow Sensor
Inspiratory Filter
Inspiratory Tubing
P roximal
P ressure Tube
Expiratory
Filter
Exhalation
Valve
P ilot Tube
Expiratory Tubing
Water Trap
Wye
Internal Battery
Exhalation
Valve
Figure C-1. Gas Delivery System
C-2
1. The Altitude Compensation feature is enabled (set to “YES” on the Setup Screen) by default and should remain at this setting.
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Modes and Breath Types
D.1
Modes of Ventilation
This chapter is a general description of the various modes of ventilation and breath types available with the Puritan Bennett™ 540 Ventilator.
Note:
The default ventilation mode setting is PRES A/C; for more information, see below.
D.1.1 Assist/Control (A/C) Modes
When set to an 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 and inspiratory time.
Whether initiated by the patient or the ventilator, all breaths are delivered at the same preset volume or pressure and inspiratory time.
The names of the Assist/Control modes are:
• VOL A/C, if the breaths are based on a volume setting
• PRES A/C, if the breaths are based on a pressure setting
D.1.2 SIMV Modes
When set to a SIMV (Synchronized Intermittent Mandatory Ventilation) Mode, machineinitiated breaths are delivered at a clinician-set volume or pressure, 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 is pressure-supported.
CPAP spontaneous breaths are not available in SIMV modes.
The names of the SIMV modes are:
• V SIMV, if mandatory breaths are based on a volume setting
• P SIMV, if mandatory breaths are based on a pressure setting
Modes and Breath Types
D.1.3 CPAP Mode
In CPAP, the ventilator maintains a constant level of pressure in the patient’s airway.
D.1.4 PSV/CPAP Mode
Like CPAP mode, PSV/CPAP mode maintains a constant level of pressure in the patient’s airway. In addition, the ventilator applies a clinician-set pressure (Pressure Support) 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 his or her lungs.
D.2
Breath Types
Breath types available from the ventilator are:
• Volume breaths in Assist/Control mode (in VOL A/C or V SIMV)
• Pressure controlled breaths in Assist/Control mode (in PRES A/C or P SIMV)
• Volume breaths and pressure-supported breaths in SIMV mode (V SIMV and P SIMV) or PSV
• CPAP
D.2.1 Volume Breaths in Assist/Control Mode
In VOL A/C each delivered breath will be of the selected volume (Vt), delivered over the selected inspiratory time (Insp Time). Inspiration is triggered by patient-generated flow (for assisted breaths) or by the ventilator.
For controlled breaths, breath rate (R-Rate) is the controlling parameter. For both controlled and assisted breaths, the inspiration is limited by the volume and is cycled by inspiratory time (Insp Time).
The shape of the flow waveform can be either a decelerated (D) ramp, or a (SQ) square wave, according to the Flow Pattern setting. See the waveforms at the top of the next page.
D-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Airway
Pressure
Start of Inspiration
Modes and Breath Types
End of Inspiration
Airway
Pressure
Start of Inspiration End of Inspiration
Flow Flow
Volume
Volume
Time
Time
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A D-3
Modes and Breath Types
A/C mode guarantees a maximum period between breaths, as determined by the Breath Rate setting. In the waveform below, the ventilator delivers a controlled (machine) breath, and calculates the time before another controlled breath must be delivered. The ventilator delivers a second controlled breath at the conclusion of the machine calculated breath time (for simplicity, we will use the term period for “machinecalculated breath time“). Following the second controlled breath, but before another period can elapse, the patient's effort triggers an assisted (or patient-initiated) breath. This restarts the period. At the conclusion of the period, the ventilator delivers another controlled breath.
Period Period Period
Airway
Pressure
Machine breath Machine breath Patient Initiated Breath
Time
Machine breath
D.2.2 Pressure Control in Assist/Control Mode
In Assist/Control mode (PRES A/C), each delivered breath will maintain the selected pressure (P Control) maintained over the selected inspiratory time (Insp Time). Inspiration is triggered by patient-generated flow
(for assisted breaths) or by the ventilator (for controlled breaths; breath rate [R-Rate] is the controlling parameter). For both controlled and assisted breaths, the inspiratory pressure is limited to the pressure
(P Control) setting, and is cycled by time.
The shape of the pressure waveform depends on the setting of the pressure rise time (Rise Time). Refer to the waveforms shown below.
Start of Inspiration End of Inspiration Start of Inspiration End of Inspiration
Airway
Pressure
Airway
Pressure
Flow
Flow
Time Time
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Modes and Breath Types
Pres A/C mode guarantees a maximum period between breaths, as determined by the Breath Rate setting.
In the next waveform (shown on the following page), the ventilator delivers a controlled (machine) breath, and calculates the time before another controlled breath must be delivered. The ventilator delivers a second controlled breath at the conclusion of the machine calculated breath time (for simplicity, we will use the term period for “machine-calculated breath time“). Following the second controlled breath, but before another period can elapse, the patient's effort triggers an assisted (or patient-initiated) breath. This restarts the period. At the conclusion of the period, the ventilator delivers another controlled breath.
Period Period Period
Airway
Pressure
Machine breath Machine breath Patient Initiated Breath
Time
Machine breath
D.2.3 Volume Breaths in V SIMV Mode
In V SIMV the mandatory volume breaths deliver the selected volume (Vt) over the selected inspiratory time
(Insp Time). Inspiration is triggered by patient-generated flow (for assisted breaths) or by the ventilator (for controlled breaths; breath rate [R-Rate] is the controlling parameter). For both controlled and assisted breaths, the inspiration is limited by the volume and is cycled by volume and time.
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Modes and Breath Types
The shape of the flow of volume cycles is of the Square type. See the waveforms below.
Airway
Pressure
Start of Inspiration End of Inspiration
Flow
Volume
Time
SIMV mode will also deliver pressure supported breaths (refer to the description for Pressure supported breaths). The SIMV mode is a combination of mandatory volume breaths and pressure supported breaths.
The alternation between them is determined by the setting of breath rate (R-Rate) or period.
In addition, the back up rate will enable the ventilator to ventilate in the case of patient apnea. The back up rate is equal to the maximum between 8 and the breath rate (R-Rate). The “controlled“ cycles following an apnea event will be volume cycles. These cycles end as soon as a new inspiration trigger is detected.
When the patient triggers a breathing effort, the volume and pressure cycles alternate between each other according to the breath rate setting (R-Rate). All the cycles are synchronized on inspiration triggers. A period always includes a volume cycle, plus as many pressure cycles as have been triggered by the patient; beyond the period the following inspiration trigger will initiate a new volume cycle, and so forth. Refer to the waveforms on the following page.
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Modes and Breath Types
Airway
Pressure
Flow
D.2.4 Pressure Supported Breaths in SIMV Mode
In P SIMV (or Spontaneous) modes, the supported breaths maintain the selected pressure (P Support).
Inspiration is triggered by patient-generated flow. The inspiration is terminated when inspiratory flow drops to the Exhalation Sensitivity (Exh Sens) setting.
In P SIMV, additional mandatory volume breaths will be delivered, dependent on the selected Breath Rate
(R-Rate).
The shape of the pressure waveform depends on the setting of the pressure rise time (Rise Time). Refer to the waveforms shown below.
End of Inspiration End of Inspiration
Airway
Pressure
Airway
Pressure
Flow
25%
Flow
Time
50%
Time
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Modes and Breath Types
D.2.5 CPAP
Continuous Positive Airway Pressure (CPAP) is available in Spontaneous modes. Inspiratory Pressure
(P Support) must be set to OFF. The ventilator maintains pressure at the selected PEEP over the entire breath cycle. Inspiration is triggered by patient-generated flow. Inspiration is limited by the pressure and is cycled by the patient when inspiratory flow drops to the Exhalation Sensitivity threshold (Exh Sens = 25%). Refer to the waveforms shown below.
Airway
Pressure
Start of Inspiration End of Inspiration
Flow
D.3
Ventilation Modes and Apnea
In SIMV mode with apnea time (Apnea Time) settings, the ventilator will sound an APNEA alarm if no patient effort occurs during the apnea time. During an APNEA alarm, the ventilator delivers breaths at a breath rate (Backup Rate) equal to the maximum of 8 and the breath rate setting (R-Rate). If the patient initiates a spontaneous breath, the ventilator will stop the controlled breaths and return to the previous operating parameters.
In PSV mode, the back-up rate is activated so that the ventilator will automatically begin to deliver breaths at the breath rate (Backup R) setting if no patient effort occurs for the Apnea Time setting. The pressure during a back-up breath is equal to the Pressure Support (P Support) setting before the apnea condition began. If the patient initiates a spontaneous breath while the back-up rate is in effect, the ventilator will return to the previous operating parameters.
In CPAP, a Backup Rate is not set, but the operator must still set an apnea time (Apnea Time). In that case, the ventilator will sound an APNEA alarm if no breath is triggered by the patient in the apnea time; however, no back up breaths will be generated.
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Operational Verification Checklist
The operational verification and safety checks listed in
below should be performed to ensure the ventilator is operating properly in the following circumstances:
• Prior to using the ventilator with a patient
• Monthly while the ventilator is in use
• Following maintenance or changes in ventilator settings
If the ventilator fails any of the safety checks below, or if you cannot complete these checks,
refer to section 5.8, “Troubleshooting,” on page 5-13
or call the equipment supplier or
Covidien (refer to section 10.4, “Service Assistance,” on page 10-6
).
Warning
• Provide the patient with an alternate means of ventilation before conducting these tests.
• To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
Table E-1. Operational Verification Checklist
7
8
3
4
1
2
5
6
9
Verify the proper appearance and cleanliness of the ventilator.
Verify all of the labels and markings on the ventilator are clear and legible.
Confirm the air inlet filter is clean and correctly installed.
Ensure the AC power cable does not exhibit any signs of damage, such as kinks, breaks, or damaged insulation.
Pass
Pass
Pass
Pass
Connect the AC power cable.
Ensure that all power supply indicators on the front panel flash, except for the
AC power supply (mains) indicator, which should remain lit.
Push the power switch I/O to the I position to activate the ventilator test:
Check that the two alarm indicators and the Standby indicator (located close to the VENTILATOR ON/OFF key) flash. Ensure also that the two alarm buzzers sound.
Pass
Pass
Perform the Functioning Alarms Test (refer to Appendix F, “Alarms Tests”
). Pass
Verify the alarm volume is adapted to the patient environment. Refer to section
7.3, “Preferences Menu Parameters,” on page 7-6 for instructions on changing
the alarm volume setting.
Ensure that you know how to charge the internal battery. Refer to chapter ,
Pass
Pass
Operational Verification Checklist
Table E-1. Operational Verification Checklist (Continued)
10
11
Verify that the preventive maintenance schedule for the ventilator is followed.
Refer to chapter , “Routine Maintenance”.
Ensure the patient breathing circuit is correctly attached to the ventilator, with all the necessary components, and is free from any signs of damage and leaks. If exhaled volume monitoring is required, use the double-limb circuit for exhaled tidal volume or minute volume monitoring.
Pass
Pass
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Alarms Tests
Before connecting the ventilator to the patient, perform the following tests to ensure the ventilator‘s alarms are working properly.
Warning
• Provide the patient with an alternate means of ventilation before conducting these tests.
• If the ventilator fails any alarm test or if you cannot complete these tests, see the
Troubleshooting section (refer to chapter , “Alarms and Troubleshooting”) of this manual or
.
• The setting of the Low PIP alarm must be adjusted for the patient, but must also be set high enough to allow the LOW PRESSURE DISCONNECT alarm to trigger properly. Perform the
Low Pressure Test (refer to section F.1, “Low Pressure Test,” on page F-1
) to ensure the Low
PIP alarm is properly set.
Note:
Most of these tests require that an approved patient circuit be connected to the ventilator. Ensure that your patient circuit is properly connected prior to performing these tests.
F.1
Low Pressure Test
Warning
The setting of the Low PIP alarm must be adjusted for the patient, but must also be set high enough to allow the LOW PRESSURE DISCONNECT alarm to trigger properly. Perform the following test to ensure the Low PIP alarm is properly set.
1. Before proceeding, set the ventilation parameters specified by the patient’s clinician and specify a single or dual circuit setup.
2. Press the VENTILATION ON/OFF key to start ventilation.
3. Keep the patient‘s end of the breathing circuit open and allow ventilation to continue.
4. Wait for (Apnea Time + 2 seconds; Apnea time is not always 5 seconds), then ensure that:
• the High priority indicator (red color) lights up
• the “LOW PRESSURE DISCONNECT” alarm is displayed
• the audible alarm sounds
Alarms Tests
5. Press the ALARM CONTROL key once to silence the alarm.
6. Press the VENTILATION ON/OFF key for three (3) seconds, then release it. The ventilator will switch to Standby mode and cancel the alarms.
F.2
Apnea Test
Apnea breaths only apply in a spontaneous and SIMV mode.
Note:
Testing of Apnea detection should be done in PSV/CPAP mode.
1. Connect the patient end of the patient circuit to a test lung.
2. Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on
3. Press the VENTILATION ON/OFF key to start ventilation.
The ventilator will deliver a mandatory breath. Before the second mandatory breath is delivered, verify that the following events occur:
• the Medium priority indicator (yellow color) illuminates
• the “APNEA“ alarm is displayed
• an audible alarm sounds
4. Press the ALARM CONTROL key twice to reset the alarm.
5. Press the VENTILATION ON/OFF key for three (3) seconds before releasing it. Ventilation stops.
F.3
Power Failure Test
Note:
If the ventilator is operating on either the external power supply or the internal battery, you must plug it in to an AC power source before beginning this test.
1. Disconnect the ventilator from its AC power supply. Ensure that the following events occur:
• the Medium priority indicator (yellow color) illuminates
• the “AC POWER DISCONNECTION“ alarm activates
• an audible alarm sounds
• the DC POWER indicator illuminates if the DC power source is connected; otherwise, the
INTERNAL BAT indicator illuminates
2. Press the ALARM CONTROL key twice to reset the alarm.
3. Reconnect the ventilator to its AC power supply.
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Alarms Tests
F.4
Occlusion Test
Note:
Occlusion testing can only be done in Pressure modes.
When using a single limb circuit do the following:
1. Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on
).
2. Block the exhalation port on the exhalation valve of the patient circuit. Refer to
Figure F-1. Blocking the Patient End of a Single Limb Circuit
3. Press the VENTILATION ON/OFF key to start ventilation.
4. Allow the ventilator to deliver three (3) consecutive breaths. At the beginning of the fourth breath, ensure that the following events occur:
• the High priority indicator (red color) illuminates
• the “Occlusion“ alarm activates
• an audible alarm sounds
5. Press the ALARM CONTROL key to silence the alarm.
6. Unblock the exhalation port.
• The alarm is canceled.
7. Press the VENTILATION ON/OFF key for three (3) seconds before releasing it.
• Ventilation stops.
F.5
High Pressure Test
1. Set the ventilator to VOL A/C mode and set the following parameter values:
• Vt: 250 ml
• PEEP: OFF
• Flow Pattern: D
• R-Rate: 30
• Insp Time: 0.4 seconds
• Insp Sens: 3
• High Pressure Alarm: 12 cmH
2
O
• Low Pressure Limit must be 4 or lower
2. Connect the patient end of the patient circuit to a Maquet™* test lung .
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A F-3
Alarms Tests
3. Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on
).
4. Press the VENTILATION ON/OFF key to start ventilation.
5. Allow the ventilator to deliver three (3) consecutive breaths. At the beginning of the fourth breath, ensure that:
• the High priority indicator illuminates
• the HIGH PRESSURE ALARM activates
• an audible alarm sounds
6. Press the ALARM CONTROL key once to silence the alarm.
7. Set the High Pressure parameter value to 40 cmH
2
O.
• The alarm is canceled.
8. Press the VENTILATION ON/OFF key for three (3) seconds.
• Ventilation stops.
F.6
Testing the Battery
determine which power source the ventilator is using by checking the power indicator, located on the top panel. The indicator light will be lit to indicate which power source is currently available.
1. Disconnect the AC power supply cable and the DC power cable (if it is connected) from the ventilator.
2. Press the ALARM CONTROL occur:
key twice to pause the alarm. Ensure that the following events
• the INTERNAL BAT indicator to the upper-left of the display illuminates
• the BATTERY symbol is displayed at the top of the screen (along with its reserve capacity)
• a single “beep” sounds every hour
3. Connect the AC (mains) power supply. Ensure that the following events occur:
• the AC POWER indicator to the upper-left of the display illuminates
• the INTERNAL BAT indicator to the upper-left of the display is flashing, which indicates that the battery is charging (this only occurs if the vent has run on battery power long enough to lose enough charge that the charger will turn on)
• the BATTERY to the upper-left of the display symbol is no longer displayed at the top of the screen
• a single “beep“ no longer sounds
F.7
Involuntary Stop Test
To verify proper functioning of the Very High Priority audible alarm, perform the following.
1. Press the VENTILATION ON/OFF key to start ventilation.
2. Set the I/O switch to the O (off) position to power-down the ventilator during ventilation. Ensure that the following events occur:
• An audible alarm sounds continuously
• The ventilator turns off. There should be no alarm indicators illuminated and no alarm messages displayed.
3. Press the ALARM CONTROL key once to silence the audible alarm.
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Unpacking and Preparation
The Puritan Bennett™ 540 Ventilator is shipped from the factory with the following items:
(1) Printed User's Manual
(1) Clinician's Manual on CD (a print copy is available upon request by the customer)
(1) Patient circuit and valve in one of the following configurations (as requested by the customer):
• Adult Single Limb
• Adult Double Limb
• Pediatric Single Limb
• Pediatric Double Limb
(1) Set of six (6) combination foam/fine particle air inlet filters
(1) Dual bag
(1) Oxygen connector
(1) AC power cable (US version)
Warning
• Users must always possess an additional circuit and valve while using the Puritan Bennett
540 Ventilator.
• To minimize the risk of damage, you must use the Dual Bag to transport the Puritan Bennett
540 Ventilator. Refer to
To unpack and prepare the ventilator, follow the steps below.
1. From the plastic bag, remove the following:
• Plastic pocket containing the User’s and Clinician’s Manual.
•
The ventilator and its components and/or accessories.
2. Remove the patient circuit, the AC (“Mains”) power cable, and the set of fine-particle air inlet filters (see
).
Unpacking and Preparation
3. Inspect the ventilator and ensure that:
• the ventilator’s outer casing and the I/O switch’s protective cover do not have any dents or scratches, which may indicate possible damage.
• the ventilator’s labels and markings are clear and legible.
• the AC power cable does exhibit any signs of damage, such as kinks, breaks, or cuts.
Warning
Never use a ventilator or any components or accessories that appear to be damaged. If any signs of damage are evident, contact your equipment supplier or Covidien.
4. Clean the ventilator with a mild soap solution, if necessary (refer to chapter , “Cleaning”).
5. Ensure that the air inlet filter is installed.
G-2 10071604 Rev. A
Figure G-1. Puritan Bennett™ 540 Portable Ventilator
Puritan Bennett™ 540 Ventilator Clinician’s Manual
Figure G-2. Dual Bag
Unpacking and Preparation
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Parts and Accessories
Table H-1 provides a list of accessories that are available for the Puritan Bennett™ 540
Ventilator.
To order parts or accessories, contact your equipment supplier or Covidien representative.
Note:
The ventilator is shipped from the factory with the following items: a printed User’s Manual; a CD with Clinician’s Manual (printed copy available upon request); one patient circuit with valve; one set of six (6) combination foam/fine particle air inlet filters; one dual bag; one O
2
connector; and one
AC power cable (US version).
Table H-1. List of Consumables and Accessories
Description
Carrying bag (grey)
Oxygen inlet connector
Carrying belt
Suspension belt
Backpack Padded Straps
Remote Alarm Box and Cable
Ventilator Cart
Dual Bag delivered with:
Backpack Padded Straps, 2 ea.
Suspension belt
Carrying belt
Warning
To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the
ventilator. See Figure G-2 on page G-3.
AC (mains) power cable
DC power cable (for connection to an external
DC power source, such as a car cigarette lighter)
Remote alarm cable (5 meters)
Parts and Accessories
Table H-1.
List of Consumables and Accessories (Continued)
Description
USB cable, mini B
Exhalation block, single-patient use (blue)
Inlet air combi-filter, fine (pack of 6)
Note:
This is the “foam plus fine particle” filter listed in
Table 10-1, Consumables and Replacement
Internal battery
External battery
DAR™ Inspiratory Bacteria Filters
Electrostatic Filter, Large (formerly Barrierbac)
Electrostatic Filter, Small (formerly Barrierbac S)
Electrostatic Filter; Small, Angled Port
(formerly Barrierbac S Angled)
Adult-Pediatric Electrostatic Filter HME, Large
(formerly Hygrobac)
Adult-Pediatric Electrostatic Filter HME, Small
(formerly Hygrobac S)
Adult-Pediatric Electrostatic Filter HME; Small,
Angled Port (formerly Hygrobac S Angled)
Infant-Pediatric Electrostatic Filter HME, Small
(formerly Hygroboy)
Adult-Pediatric Mechanical Filter HME, Large
(formerly Hygroster)
Adult-Pediatric Mechanical Filter HME, Compact
(formerly Hygroster Mini)
Mechanical Filter, Large (formerly Sterivent)
Mechanical Filter, Compact (formerly Sterivent S)
Mechanical Filter, Small (formerly Sterivent Mini)
Adult-Pediatric HME (formerly Hygrolife II)
Table H-2 provides a list of consumable parts available for the ventilator.
Warning
• To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this
tubing as measured from the ventilator outlet to the ventilator inlet is 3.6 feet (1.10 meters) to 6.6 feet
(2.00 meters).
The tubing must conform to all applicable standards and must be fitted with Ø 22 mm terminals that also conform to all applicable standards. Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume: a corrugated tube of Ø 22 mm for adult patients, and a corrugated tube of Ø 15 mm for pediatric patients with a tidal volume lower than 200 ml.
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Parts and Accessories
Table H-2. List of Circuits
Description
Double limb patient circuit with exhalation valve,
180 cm, PVC, sterile, ADULT
Double limb patient circuit with exhalation valve,
180 cm, PVC, sterile, PEDIATRIC
Single limb patient circuit with exhalation valve, 180 cm,
PVC, sterile, ADULT
Single limb patient circuit with exhalation valve, 180 cm,
PVC, sterile, PEDIATRIC
Hudson RCI™* single limb patient circuit, ADULT
Hudson RCI™* double limb patient circuit, ADULT
Allegiance™*/Cardinal™*/Airlife™* single limb patient circuit, ADULT
Part Number
5094000
5093900
5093600
5093500
1696
690-50
6463-H08
For an updated list of validated circuits or more information regarding parts and accessories for the
Puritan Bennett™ 540 Ventilator visit the SolvIT SM Center Knowledge Base by clicking the link at http://www.puritanbennett.com.
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Glossary
AC Power
Alternating current.
Alarm Pause
The audible and visual alarms cease and the symbol appears. The symbol will remain until the cause of the alarm is addressed. For example, when the ventilator is running on internal battery, the AC Disconnection alarm may be paused, and the alarm paused symbol will appear until the device is plugged into AC. The paused alarm will be captured in the alarm log screen and can be reactivated.
Alarm Reset
Used only for the High Pressure alarm, this function resets the visual alarm message.
Apnea
The absence of breathing or a breathing pattern capable of supporting an individual's respiratory needs.
Apnea Time
Time allowed between breath starts before APNEA alarm occurs when no patient effort is detected.
Assist/Control
In Assist/Control mode, the ventilator delivers an assisted breath of a set volume or set pressure when the patient's breathing effort creates a flow or pressure drop that is greater than the
SENSITIVITY setting. In absence of patient breathing effort, the ventilator will deliver a controlled breath of the set volume or pressure. (Does not apply in PSV/CPAP mode).
Assisted breath
A volume or pressure breath triggered by the patient but then controlled and terminated by the ventilator.
Audio Pause
Pauses the audible alarm for 60 seconds at a time and shows the to as “Alarm Silence.”
symbol; often referred
Glossary
I-2
Back Up Rate
Rate of control cycles in PSV or SIMV modes during apnea phase.
Battery Level
Display of the remaining battery capacity; located adjacent to the battery symbol.
Bias flow
Turbine flow during exhalation phase through the patient circuit to avoid rebreathing.
bpm
An abbreviation for “breaths per minute,” which is the unit of measure for breath rate (see below).
Breath Rate
The total number of breaths, both machine and spontaneous, delivered by a ventilator in one minute.
Caregiver
An individual who assists a patient with the tasks of daily living. This may be a family member, a live-in assistant, or the nursing staff of a health care facility.
cmH
2
O
An abbreviation for “centimeters of water,” which is a unit of measure for pressure.
Continuous Positive Airway Pressure (CPAP)
Continuous airway pressure maintained throughout a spontaneous breath cycle.
Controlled breath
A volume or pressure breath triggered, controlled and terminated by the ventilator.
Double Limb patient circuit
Patient circuit with a tube between the ventilator gas outlet and the patient for inspiratory gas and another tube between the patient and the expiratory block for expiratory gas.
Exhalation block
Part of the ventilator that allows the connection of the exhalation limb of the patient circuit. The exhalation block is for single-patient use only.
Exhalation phase
Phase of the breath cycle during which the patient exhales.
Exhaled Tidal Volume (VTE)
Exhaled volume measured for all breath types through the exhalation block. Monitored value available only with double limb patient circuit.
Expiratory minute volume (Min VE)
Volume exhaled by the patient at each expiratory phase and multiplied times the respiratory rate.
Exhalation sensitivity
The exhalation sensitivity (Exh Sens) level is a percentage of peak flow at which a pressure-supported breath will be terminated.
10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Glossary
Expiratory Tidal Volume (VTE)
Exhaled volume measured for all breath types through the exhalation block. Monitored value available only with double limb patient circuit.
Flow
Volume of gas delivered by the ventilator compared to time, expressed in liters per minute (lpm).
Freeze
Interruption of the waveform plot tracing on the ventilator’s display.
I:E ratio
Inspiratory time versus exhalation time ratio.
Inspiratory minute volume (Min VI)
Volume delivered to the patient at each inspiratory phase and multiplied times the respiratory rate.
Inspiratory Phase
Phase of the breath cycle during which the patient inspires.
Inspiratory Sensitivity
Level of inspiratory effort the patient has to provide during the initiation of a machine breath. The sensitivity levels (from 1 to 5) correspond to differences in flow compared to the bias flow. The level 1 is the most sensitive (for a pediatric use) and requires the least effort to trigger breath. The level 5 requires the most amount of effort to trigger a breath.
Inspiratory Tidal Volume (VTI)
Volume delivered to the patient at each inspiratory phase. In a leak condition the displayed VTI may reflect higher values than what is delivered to the patient.
I Time
Inspiratory time measure.
L
Liters (a unit of volume).
LED
Light Emitting Diode; used as indicator lights on the ventilator’s front panel.
lpm
Liters Per Minute (a unit of volume flow rate).
Machine Hours
Counter for the total ventilation time since manufacture or the last CPU board change.
Mains
AC power supply.
MAP
Mean Airway Pressure. Average pressure during a ventilation cycle.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A I-3
Glossary
Minimum Exhalation Time
Minimum exhalation time before allowing the patient inspiratory trigger.
Minimum Inspiratory Time
Minimum inspiratory time before allowing the patient to exhale.
Minute Volume
Minute Volume represents the total amount of gas volume moved into the lungs over a 60 second period. It is calculated by multiplying the average breath-to-breath inspired gas volume (Tidal Volume in liters or milliliters) by the respiratory rate (in breaths per minute). Minute volume is usually expressed in Liters per minute and is a better reflection of the patient's total ventilation status than either respiratory rate or tidal volume alone.
Pause
Waveforms freezing function.
Patient Breath
Breathing cycle initiated by the patient.
Patient Counter
Counter of ventilation time for the patient.
Patient effort
Inspiratory effort initiated by the patient.
Patient circuit
Tubing between the ventilator and the patient.
Peak Inspiratory Pressure (PIP)
The highest pressure measured in the patient circuit during the inspiration phase.
Positive End Expiratory Pressure (PEEP)
Pressure in the patient circuit at the end of expiration.
Pressure Control
Augmentation of the patient's ventilation synchronously with inspiratory effort until a preset pressure is met. Pressure is maintained throughout patient inspiratory flow, and is cycled to expiration by time
(controlled by the selected Inspiratory Time setting). Used in Assist/Control mode.
Pressure Support
Augmentation of the patient’s ventilation synchronously with inspiratory effort until a preset pressure is met. Pressure is maintained until inspiratory flow is reduced to a percentage of peak flow that depends on the expiratory sensitivity setting for the inspiration, when the ventilator cycles into exhalation. Available in
SIMV or Spontaneous modes.
PSI
Pounds Per Square Inch.
Rebreathing
The patient breathes his/her exhaled gas.
I-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Glossary
Respiration rate
The number of breath cycles (inspiration + expiration) completed within one minute
.
Normal resting adult respiratory rates are from 16 – 20 breaths per minute (bpm).
Rtot
Parameter measured by the ventilator equal to the total number of breaths per minute (bpm).
Volume breath
Inspiration of the selected volume, delivered over the selected inspiratory time.
Sensitivity
This adjustable parameter determines the amount of inspiratory effort required by the patient before the ventilator delivers an assisted breath, or demands flow in the case of a spontaneous breath.
The Puritan Bennett™ 540 Ventilator is flow-triggered, with sensitivity levels in the range from 1 to 5: the lower the number, the more sensitive the trigger.
Spontaneous
A ventilation mode that delivers assisted breaths only. Spontaneous mode does not provide breaths if the patient does not make an inspiratory effort greater than the sensitivity settings and there is no apnea backup rate.
Standby
The operational mode of the ventilator where it is powered (power supply I/O button set to the I position), but is not ventilating the patient.
Synchronous Intermittent Mandatory Ventilation (SIMV)
A ventilator mode which provides a mechanism for synchronizing the ventilator-delivered breaths with a patient's inspiration, as detected by the ventilator.
Tidal volume (Vt)
Volume of gas delivered to the patient in a breath.
Unfreeze
Resumption of the waveform plot tracing on the ventilator’s display.
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A I-5
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I-6 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
S ECTION
Index
A
AC power
AC power cable
AC POWER DISCONNECTION alarm message 5-7, 5-13
Accessories
ADR regulations
international transport of the ventilator (Europe) 8-1
Air circulation (Warning) 1-3, 6-1
checking regularly (Caution) 10-4
Air inlet filter, replacing (figure) 10-4
Air outlet (antibacterial) filter
Air transport of the ventilator (Warning) 8-1
Alarm Logs menu
dismissing automatically 5-4 dismissing manually 5-4
Alarm messages
AC POWER DISCONNECTION 5-7, 5-13
BATT FAULT1 CALL SERVICE 5-7, 5-14, 8-4
BATT FAULT2 CALL SERVICE 5-7, 5-14
BATT FAULT3 CALL SERVICE 5-7, 5-14
BATT FAULT4 RESTART/SRVC 5-7, 5-15
CHECK PROXIMAL LINE1 5-8, 5-16
CHECK/CHANGE EXH VALVE1 5-8, 5-16
CHK EXH VALV RESTART VENT 5-8, 5-16
CHK VOL/INSP TIME SETTINGS 5-8, 5-17
DEVICE FAULT1 RESTART/SRVC 5-9, 5-17
DEVICE FAULT2 RESTART/SRVC 5-9, 5-17
DEVICE FAULT3 RESTART/SRVC 5-9, 5-17
DEVICE FAULT4 RESTART/SRVC 5-9, 5-17
DEVICE FAULT5 RESTART/SRVC 5-9, 5-17
DEVICE FAULT6 RESTART/SRVC 5-9, 5-17
DEVICE FAULT7 RESTART/SRVC 5-9, 5-17
EXHSENS FAULT OR CRKT LEAK 5-9
HIGH DEVICE TEMP COOL VENT 5-9
INVERSED I:E RATIO 1-6, 3-9, 3-13, 5-10, 5-19, 7-14
KEYPAD FAULT CALL SERVICE 5-10, 5-19
LOW BATTERY 1-4, 5-10, 5-19, 8-4
LOW PRESSURE DISCONNECT 5-11, 5-21
OCCLUSION CHECK CIRCUIT 5-11, 5-21
ON INTERNAL BATTERY 5-11, 5-21, 6-6
POWER FAULT RESTART/SRVC 5-11, 5-21
POWER SUPPLY LOSS (no message) 5-12, 5-21
SOFTWARE VERSION ERROR 5-12, 5-22
SPKR FAULT RESTART/SRVC 5-12, 5-22
Alarm parameters
Alarm thresholds
and linked Ventilation parameters 7-15
Alarms
thresholds, blocking when linked to a ventilation parameter 7-17
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A Index-1
Index
Alarms and troubleshooting 5-1
Alarms tests
continuing pressure F-3 high pressure F-3
Altitude compensation feature C-2
Anti-static tubes
Apnea
Audible alarms
autotriggering (Caution) 3-14, 3-17, 3-23
B
Backlight, display
Backup Rate
and R-Rate setting 3-21, 3-22, 3-25
BATT FAULT1 CALL SERVICE alarm message 5-7, 5-14,
BATT FAULT2 CALL SERVICE alarm message 5-7, 5-14
BATT FAULT3 CALL SERVICE alarm message 5-7, 5-14
BATT FAULT4 RESTART/SRVC alarm message 5-7, 5-15
BATT TEMP FAULT alarm message 5-7
Battery
Battery, internal
indicator, front panel (figure) 8-3
reserve capacity display, ventilation running (figure)
reserve capacity display, ventilation stopped (figure)
reserve capacity, displayed 8-2 symbol 8-2
Blocking an alarm threshold 7-17
C
CAL FAULT SEE USER MNL alarm message 10-3
Calibrating
CALIBRATION FAIL alarm message 5-16
Carbon dioxide
risk of inhalation and suffocation 1-2, 1-6, 7-20
Carrying bag, ventilator (figure) G-2
Cautions
Changing ventilation modes 7-12
CHECK PROXIMAL LINE1 alarm message 5-8, 5-16
CHECK PROXIMAL LINE2 alarm message 5-8
CHECK SETTINGS alarm message 5-8, 5-16
CHECK/CHANGE EXH VALVE1 alarm message 5-8, 5-16
CHECK/CHANGE EXH VALVE2 alarm message 5-8
CHK EXH VALV RESTART VENT alarm message 5-8, 5-16
CHK VOL/INSP TIME SETTINGS alarm message 5-8, 5-17
Cleaning
Accessories 9-2 exhalation block 9-2
Cleaning solutions and products, approved 9-2
Clinician
Connecting the oxygen supply 6-14
Connecting to
Consumables
Contrast (display), setting 7-9
CPAP mode
D
Dangerous Goods Classification 8-1
DC power
DC power cable
connecting to ventilator 6-6 disconnecting from ventilator 6-6
DEVICE FAULT1 RESTART/SRVC alarm message 5-9, 5-17
DEVICE FAULT2 RESTART/SRVC alarm message 5-9, 5-17
DEVICE FAULT3 RESTART/SRVC alarm message 5-9, 5-17
DEVICE FAULT4 RESTART/SRVC alarm message 5-9, 5-17
DEVICE FAULT5 RESTART/SRVC alarm message 5-9, 5-17
DEVICE FAULT6 RESTART/SRVC alarm message 5-9, 5-17
Index-2 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Index
DEVICE FAULT7 RESTART/SRVC alarm message 5-9, 5-17
Display
setting the backlight 7-9 setting the contrast 7-9
Display Waveforms parameter 7-11
Displayed parameters
E
Electromagnetic compatibility
and mobile/portable communications equipment 6-2
Electromagnetic emissions
EMPTY BATTERY alarm message 5-9, 5-17, 8-4
Environmental specifications B-11
Exh Sens in PSV/CPAP mode 3-4, 3-18, 3-24
EXHSENS FAULT OR CRKT LEAK alarm message 5-9
Expiratory flow sensor
Expired Tidal Volume (VTE) 3-6
F
air inlet 6-11 antibacterial 6-11
Freeze function
G
Gas delivery system (diagram) C-2
H
Heat safety device, battery 6-2
HIGH DEVICE TEMP COOL VENT alarm message 5-9
HIGH EXH VOLUME alarm message 5-10, 5-18
HIGH INSP VOLUME alarm message 5-10, 5-18
HIGH MINUTE VOLUME alarm message 5-10, 5-18
HIGH PRESSURE alarm message 5-10, 5-19
HIGH RATE alarm message 5-10, 5-19
Holes, air circulation 1-3, 6-1
Hot surfaces
I
IATA regulations
air transport of the ventilator 8-1
Ignition sources (warning) 6-2
Indicator
Indicator and alarm specifications B-3
Indicators
Inhalation port closeup (figure) 6-9
Inserts
Insp Sens 3-3, 3-9, 3-13, 3-17, 3-22
in CPAP mode, non-adjustment 3-4
Installation 6-1 placing the ventilator 6-1
Internal battery
maintenance (none required) 10-5
replacement interval 10-5, 10-6
Internal battery, replacing (figure) 8-6
INVERSED I:E RATIO alarm message 1-6, 3-9, 3-13, 5-10,
K
Key sound
Keyboard
locking of 7-18 unlocking 7-18
KEYPAD FAULT CALL SERVICE alarm message 5-10, 5-19
Keys
L
Linked ventilation parameters
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A Index-3
Index
Liquids
avoid ingress into ventilator (Warning) 1-3, 9-1
Lithium
internal battery, Dangerous Goods classification 8-1
Locking key
Locking Key and SETUP screen 7-3
Logs menu
LOW BATTERY alarm message 1-4, 5-10, 5-19, 8-4
LOW EXH VOLUME alarm message 5-11, 5-20
LOW INSP VOLUME alarm message 5-11, 5-20
LOW MINUTE VOLUME alarm message 5-11, 5-21
LOW PRESSURE DISCONNECT alarm message 5-11, 5-21
M
Maintenance
Maintenance option
reserved for service personnel 7-6
Manufacturer’s declaration specifications B-13
Menu
Min Vol 3-7, 3-10, 3-14, 3-19, 3-25
Modes ventilation
Monitored parameter specifications B-4
Monitored parameters
N
NO DATA message, Alarm Logs screen 5-3
Non-Invasive Ventilation (NIV) 6-10
Nose or face mask
Notes
Nurse call system
connecting the cable to the ventilator 6-19
O
OCCLUSION CHECK CIRCUIT alarm message 5-11, 5-21
ON INTERNAL BATTERY alarm message 5-11, 5-21, 6-6
Operational verification checklist E-1
O-ring, oxygen coupler (Caution) 6-15
Oxygen
connecting the supply to the ventilator 6-15 connector stud 6-15
disconnecting the supply from the ventilator 6-16 flow adjustment 6-16
rear panel connector (figure) 6-15
shut off supply when ventilation stops (Caution) 6-16
supply hose expiration date (Caution) 6-16
using medical-grade only (Warning) 1-8, 6-14
P
P SIMV Mode Menu
Parameter values
Parameters
ventilation
modifying 7-14 setting of 7-14
Parameters, operating
CPAP/PSV mode
Inspiratory Trigger Sensitivity (Insp Sens) 3-3
Pres A/C mode
Expired Tidal Volume (VTE) 3-10
Inspiratory Tidal Volume (VTI) 3-10
Inspiratory Time (Insp Time) 3-9
Inspiratory Trigger Sensitivity (Insp Sens) 3-9
Positive End Expiratory Pressure (PEEP) 3-8
Pressure Control (P Control) 3-8
Expired Tidal Volume (VTE) 3-19
Inspiratory Tidal Volume (VTI) 3-19
Inspiratory Time Controlled (Insp Time) 3-16
Inspiratory Trigger Sensitivity (Insp Sens) 3-17
Index-4 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Index
Positive End Expiratory Pressure (PEEP) 3-16
Pressure Controlled (P Control) 3-16
Pressure Support (P Support) 3-16
exhalation trigger sensitivity (Exh Sens) 3-4, 3-18,
Expired Tidal Volume (VTE) 3-6
Inspiratory Tidal Volume (VTI) 3-6
Low/High Inspiratory Time (Low I Time/High I
Positive End Expiratory Pressure (PEEP) 3-3
Pressure support (P support) 3-3
Expired Tidal Volume Control (VTE) 3-14
Inspiratory Trigger Sensitivity (Insp Sens) 3-13
Peak Inspiratory Pressure (PIP) 3-14
Positive End Expiratory Pressure (PEEP) 3-12
Expired Tidal Volume (VTE) 3-25
Inspiratory Tidal Volume (VTI) 3-25
Inspiratory Time (Insp Time) 3-22
Inspiratory Trigger Sensitivity (Insp Sens) 3-22
Peak Inspiratory Pressure (PIP) 3-24
Positive End Expiratory Pressure (PEEP) 3-22
Pressure Support (P Support) 3-21
Patient
outlet port connections (figure) 6-9
Patient circuit
length and internal volume 6-10
Patient hours
Patient wye
blocking for expiratory flow sensor calibration (figure)
Patient/Caregiver Checklist A-1
Peak inspiratory flow 3-4, 3-18, 3-24
PEEP 3-3, 3-8, 3-12, 3-16, 3-22
Performance specifications B-3
Personnel
Placing the ventilator (installing) 6-1
POWER FAULT RESTART/SRVC alarm message 5-11, 5-21
POWER SUPPLY LOSS (no message) alarm 5-12, 5-21
Precautions for use, cautions
electromagnetic interference 1-10
installation
environment 1-9 maintenance 1-9
Precautions for use, warnings
installation
electrical power supplies 1-4 hoses and accessories 1-4
Preference menu
changing the settings in 7-7 displaying 7-7
PRES A/C Mode Menu
PSV/CPAP Mode Menu
R
Range, resolution, and accuracy specifications B-5
Recharging the internal battery 8-5
REMOTE ALARM FAULT alarm message 5-12, 5-21
Repairing the ventilator
qualified personnel only (Warning) 10-1, 10-5
Replacement intervals
air inlet filter 10-5 air outlet (antibacterial) filter 10-5
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A Index-5
Index
consumables 10-5 exhalation block 10-5 patient circuit 10-5
Replacing
Replacing the internal battery 8-6
Rise Time 3-3, 3-8, 3-18, 3-24
Rtot 3-7, 3-10, 3-15, 3-19, 3-26
S
Service assistance information 10-6
Setting ventilation parameters 7-14
Setup Configuration
SETUP screen
changing parameters 7-3 screen shot 7-3
Single patient use
SOFTWARE VERSION ERROR alarm message 5-12, 5-22
Specifications
manufacturer’s declaration B-13
range, resolution, and accuracy B-5
standards compliance and IEC classification B-17
SPKR FAULT RESTART/SRVC alarm message 5-12, 5-22
Standards, compliance, and IEC clasiification specifications B-17
Storing the internal battery 8-6
T
Testing
Tidal volume
and pediatric use (Warning) 1-6, 7-14
Trigger detections, excessive (Caution) 3-14
Trigger threshold setting 3-23
modifying (Caution) 3-4, 3-10, 3-14, 3-17
Troubleshooting
Turning off the ventilator 7-21
U
Unfreeze function
Unfreezing a waveform trace 4-6
Unpacking and preparing the ventilator G-1
V
V SIMV Mode Menu
Ventilation
changing during ventilation 7-12
changing while on standby 7-11 setting 7-11
Ventilation parameters
setting when linked to alarm thresholds 7-15 setting when linked to other parameters 7-15
Ventilator
connecting the nurse call cable 6-19
connections, proper (warning) 1-3, 6-1
operation (description of) C-1
patient outlet port connections (figure) 6-9
Ventilator, and liquid ingress (Warning) 1-3, 9-1
VOL A/C Mode Menu
VTE 3-6, 3-10, 3-14, 3-19, 3-25
Index-6 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
W
Warnings
ventilator-dependent patients 3-3
Waveform menu
monitored parameters (figure) 4-2
Waveforms
Welcome Menu screen
Wheelchair
mounting the ventilator onto 6-17
Index
Puritan Bennett™ 540 Ventilator Clinician’s Manual 10071604 Rev. A Index-7
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Index-8 10071604 Rev. A Puritan Bennett™ 540 Ventilator Clinician’s Manual
Part No. 10071604 Rev. A
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