Puritan Bennett 560 302188388-Service-Manual PDF
Puritan Bennett 560 302188388-Service-Manual PDF
Puritan Bennett 560 302188388-Service-Manual PDF
TM
Puritan Bennett
560 Ventilator
Copyright information
COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for
life are U.S. and/or internationally registered trademarks of Covidien AG.
All other brands are trademarks of a Covidien company.
© 2012 Covidien.
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.
3 Operating Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3–1
3.1 PSV Mode Parameters and Setting Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . 3–1
3.2 CPAP Mode Parameters and Setting Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 3–7
3.3 P A/C Mode Parameters and Setting Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 3–9
3.4 V A/C Mode Parameters and Setting Ranges. . . . . . . . . . . . . . . . . . . . . . . . . 3–14
3.5 P SIMV Mode Parameters and Setting Ranges . . . . . . . . . . . . . . . . . . . . . . . . 3–18
3.6 V SIMV Mode Parameters and Setting Ranges. . . . . . . . . . . . . . . . . . . . . . . . 3–23
3.7 FIO2 For Various Oxygen and Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . 3–29
Clinician’s Manual i
Contents
ii Clinician’s Manual
Contents
9 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–1
9.1 Cleaning the Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–1
9.2 Cleaning the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–2
9.3 Cleaning the Exhalation Block. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–2
B Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–1
B.1 Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–1
B.2 Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–1
B.3 Indicators and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–3
B.4 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–3
B.4.1 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–3
B.5 Monitored Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–3
B.6 Range, Resolution, and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–4
B.7 Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–8
B.8 USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–8
B.9 Pneumatic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–9
B.10 Manufacturer’s Declaration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B–10
B.11 Standards Compliance and IEC Classification . . . . . . . . . . . . . . . . . . . . . . . . B–14
I Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I–1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index–1
iv Clinician’s Manual
Figures
Clinician’s Manual v
Figures
vi Clinician’s Manual
Figures
Clinician’s Manual ix
Tables
x Clinician’s Manual
Preface
Qualification of Personnel
Installation and maintenance of the device must be made by authorised 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 560 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.
Technical Support
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.
Warning
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™
560 Ventilator.
In order to use the ventilator correctly and efficiently and to help prevent incidents, please pay
particular attention to section 1.2, “Warnings”, as well as all warnings and cautions contained
throughout this manual.
1.2 Warnings
• The ventilator must be used according to its intended use. Refer to section 2.1, “Indications for
Use”.
• Be aware this manual describes how to respond to ventilator, 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 exhalation 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.
Safety Information
• 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.
• Do not use a patient circuit with a leak accessory for ventilator-dependent patients.
• 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. Provide
the patient with an alternate means of ventilation before conducting these tests.
• Verify the functionality of the alarm conditions before connecting the patient to the ventilator.
Refer to chapter F, “Alarms Tests”.
• If the ventilator fails the alarm tests or if you cannot complete the tests, refer to chapter 5.8,
“Troubleshooting” or call your equipment supplier or Covidien.
• 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, 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 ambient temperatures
are high. Some ventilator surfaces may become hot, even if safety specifications are not
exceeded.
• To minimise the risk of damage, you must use the ventilator’s Dual Bag to transport the
ventilator. See 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, in particular the batteries or electrical components, 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 leave power cables lying on the ground where they may pose a hazard.
• 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.
• 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.
• 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 to the patient provides for a secure, comfortable fit.
• Place the ventilator in a safe place when ventilating and according to the recommendations in
this manual.
• 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 ± 20 °C
(± 36 °F) from the temperature in which it will be operating, the ventilator should be allowed to
stabilise in its operating environment for at least two (2) hours prior to use.
• If the ambient temperature where the device is operated is greater than 35 °C (95 °F), the flow
supplied at the device outlet may exceed 41 °C (106 °F). 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 reduce the risk of 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.
• 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 Maintenance”). 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 ambient temperatures
are high. Some ventilator surfaces may become hot, even if safety specifications are not
exceeded.
• The operator should connect the ventilator to an AC power source whenever available, for safer
operation.
• The maximum recommended shelf life of the internal battery is two (2) years. Do not use a
battery that has been stored for two years prior to its first use.
• Periodic recharging is important to help maximize useful life of the battery. Do not store the
internal battery for extended periods, without recharging, as this may reduce the maximum life.
• 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 of the ventilator to ensure correct operation. Refer also to the electrical
specifications found in Appendix B, “Specifications”.
• 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 its internal battery to recharge.
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated on
the internal battery when no other power source is available. 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. Refer to chapter 6.3, “Connecting to an External DC
Power Source”.
• Even if the “INTERNAL BATTERY” charging indicator is off, charging of the battery may
sometimes be incomplete if the ambient temperature is above 40 °C (104 °F) because 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.
• Ensure that the AC power cable is in perfect condition and not compressed. The device should
not be turned on if the AC power cable is damaged.
• Minimum and maximum VTE alarm parameters must be properly set to warn in the event of
patient disconnection.
• Before opening the packaging for the Patient Circuit, ensure that no damage is evident to the
packaging or its contents. Do not use if evidence of damage exists.
• 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.
• The exhalation block is intended for single use by a single patient . It may periodically be
cleaned, but it cannot be disinfected or sterilised. To maintain good measurement quality when
used continuously, clean the exhalation block periodically (refer to section 9.3, “Cleaning the
Exhalation Block”). The exhalation block should be changed every 4 months and cannot be
reused with any other patient.
• During invasive ventilation (when an artificial airway bypasses the patient’s upper respiratory
system), the patient’s upper respiratory system cannot humidify the incoming gas. For this
reason, the use of a humidifier, to minimise drying of the patient’s airway and subsequent
irritation and discomfort, must be used.
• If exhaled tidal 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
minimum and maximum VTE alarm parameters must be properly set to warn in the event of
patient disconnection.
• Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause
serious damage to the ventilator.
• Before cleaning the ventilator, first disconnect the ventilator and the patient circuit.
• 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.
• The patient circuit should always be positioned to avoid hindering the patient's movements, to
prevent accidental disconnection or leakage, and to minimise 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). To ensure proper
performance of the ventilator, See Table H-2, List of Circuits, on page H-2, for a list of
recommended patient circuits.
• Resistance of the exhalation valve and accessories (water traps, filters, HMEs 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™ 560 Ventilator.
• Always ensure that the humidification device is positioned 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 gas delivered
to the patient. Gas 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, HMEs
etc) must be as low as possible. Settings – particularly the PATIENT DISCONNECTION alarm,
maximum inspired volume (Max VTI), and minimum inspired volume (Min 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 1.1 metres (3.6 feet) to 2.0 metres (6.6 feet). 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.
• To ensure proper performance of the ventilator, use only accessories (including oxygen
accessories) approved and recommended by Covidien. See Appendix H, “Parts and Accessories”
or contact your customer services.
• When using non-invasive ventilation (NIV) without an exhalation valve, use a vented nose or
face mask or a non vented combined with a leak accessory. When using non-invasive ventilation
(NIV) with an exhalation valve, use a non-vented mask.
• Before using the Nurse Call system, ensure that its connections are secure and it operates
properly. For more information, contact Covidien.
• 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.
• 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 exhalation gas, primarily carbon dioxide, may be inhaled by
the patient.
• 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.
• Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering
spontaneous breaths.
• 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 adult or pediatric use ensure that the adjusted tidal volume 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 PATIENT DISCONNECTION 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.
• If an APNEA alarm is required, set the APNEA setting to YES in the Preferences Menu.
• The Apnea Alarm should be set to YES for ventilator dependant patients.
• 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.
• 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.
• In the SIMV mode the use of a double limb circuit is recommended. The Min VTE 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.
• The inspiration trigger threshold should be carefully modified 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.
• 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 ensure proper servicing and avoid the possibility of physical injury to personnel or damage to
the ventilator, only personnel authorised and qualified by Covidien should attempt to service or
make authorised modifications to the Puritan Bennett™ 560 Ventilator.
• 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.
• To ensure proper performance of the ventilator, the preventative maintenance schedule should
be followed. For further information contact Covidien.
• 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
Table 9-1.
• 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.
• Do not attempt to open, repair or otherwise service the ventilator yourself. Doing so might
endanger the patient, damage the ventilator, and/or void your warranty. Only personnel
authorised and qualified by Covidien should repair, open 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 sterilised. To maintain good measurement quality when
used continuously, clean the exhalation block periodically (refer to section 9.3, “Cleaning the
Exhalation Block”). The exhalation block should be changed every 4 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 exhalation flow sensor be recalibrated before the
exhalation block is used. Refer to section 10.1, “Calibrating the Exhalation Flow Sensor”.
• The patient circuit is intended for single use by a single patient and should be changed
according to the manufacturer’s recommendations and according to the patient circuit lifetime.
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”.
• 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 Maintenance”). 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.
• 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 odour, alarms not
triggered during the start-up procedure), the oxygen and power supplies should be disconnected
and use of the device stopped immediately.
• Before using the ventilator’s internal battery, ensure that the battery is fully charged and that
the charge holds. Back up ventilators or those in storage should be connected to an AC power
source to protect the integrity of the battery.
• The maximum recommended shelf life of the internal battery is two (2) years. Do not use a
battery that has been stored for two years prior to its first use. Periodic recharging is important
to help maximize useful life of the battery. Do not store the internal battery for extended
periods, without recharging, as this may reduce the maximum life.
• 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.
• 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.
• 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.
• Oxygen therapy for patients with respiratory failure is a common and effective medical
prescription. However, be aware that inappropriate oxygen use may potentially 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 oxygen connector.
• To avoid injury to the patient and/or possible damage to the ventilator: before connecting the
ventilator to the oxygen supply, ensure a flow meter (flow regulator) is connected to the
ventilator to regulate the oxygen supply to the required specification.
• The Puritan Bennett™ 560 Ventilator can be used with an optional oxygen analyser with
minimum and maximum concentration alarms. Always measure the delivered oxygen with a
calibrated oxygen analyser (FIO2 kit) that features a minimum and maximum concentration
alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
• The Puritan Bennett 560 Ventilator is designed to deliver a percentage of oxygen equal or lower
than 50%. Do not exceed this value as this may cause the ventilator to malfunction and put the
patient at risk.
• Ensure that the oxygen supply pressure to the machine never exceeds 7 psi (50 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. Circulate fresh air into the 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 humidifier
upstream of the ventilator.
• To ensure stability, when the Puritan Bennett 560 Ventilator is mounted on a cart, the weight of
the oxygen bottle should not exceed 14 kg (30 lbs).
• 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.
• Before connecting the oxygen supply, ensure that the stud on the oxygen connector is
protruding outwards.
• Inspect the oxygen coupler 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.
• 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.
Symbols Descriptions
It is essential to read, understand, and follow these instructions before using the Puritan Bennett 560
Ventilator (ISO 7000-0434A).
This symbol appears on the ventilator’s back panel, see Table 1-2, item 5.
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 5.
Direct current, DC (IEC 60417-5031).
This symbol appears on the ventilator’s back panel and keyboard; see Figure 1-4, item 9.
CE – Conformity European
Signifies compliance with the medical device directive 2007/47/EC.
This symbol appears on the ventilator’s back panel; see Table 1-2, item 5.
Symbols Descriptions
This symbol appears on the ventilator’s front panel UP/UNFREEZE key; see Figure 2-3 on page 2-6,
item 4.
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 6.
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 5.
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 F, “Alarms Tests.”
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.
To patient port.
This symbol appears on the front right of the ventilator, adjacent to the To Patient port;
see Figure 1-1 on page 1-15, item 1.
From patient-port (double-limb option).
This symbol appears on the front-left of the ventilator, adjacent to the From Patient port; see Figure 1-1
on page 1-15, item 4.
Patient proximal pressure port.
This symbol appears on the front right of the ventilator, adjacent to the From Patient port;
see Figure 1-1 on page 1-15 and Figure 1-4 on page 1-17, item 3.
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 Figure 1-1 on page 1-15, and Figure 1-4 on page 1-17, item 3.
Oxygen inlet.
This marking appears on the back panel of the ventilator, adjacent to the oxygen inlet port;
see Figure 1-3 on page 1-16, item 2.
Nurse Call connector.
This symbol appears on the back panel of the ventilator, adjacent to the nurse call connector;
see Figure 1-3 on page 1-16, item 2.
Switch in “Off” position (IEC 60417-5008).
O 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).
I 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.
Symbols Descriptions
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 7.8, “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,
“Operating Parameters”. 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 V A/C mode only. For
more information, refer to chapter 3, “Operating Parameters”. In volume ventilation mode you can
select between Square (SQ), Descending (D) or Sinusoidal (S) flow patterns.
Selected line (filled square).
When making menu choices, this graphic indicates the line on which the cursor is currently positioned.
See Figure 7-11, Selecting the Preferences Menu, on page 7-10.
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.
Manufacturer.
Audio Paused.
This symbol means the sounding of audible alarms is currently disabled. For more information, refer to
section 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”.
Symbols Descriptions
Apnea Alarm Deactivated.
This symbol means that the Apnea Alarm has been deactivated. For more information, refer to section
5.5, “Pausing/Resetting Alarms”.
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.
See Figure 2-2, item 11.
PC connector.
This symbol indicates a port that can be used by authorised Covidien product service personnel or
Covidien service personnel for software maintenance. See Figure 2-2, item 10.
Humidity limitations.
Temperature limitations.
Fragile.
Keep dry.
Location of AC
Power Cable Location of DC
Connector Power Cable
Connector
Note:
The item number callouts in the following figures refer to those listed in Table 1-2.
1
13
4 3
6
4
11
10 9
8
5
12 2 2
3
4 1
13
Target Patients
Specifically, the ventilator is applicable for adult and pediatric patients who require the following
general types of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:
• Positive Pressure ventilation
• Assist/Control, SIMV, or CPAP modes of 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.
The Puritan Bennett 560 Ventilator is suitable for use on commercial aircraft, per FAA requirements.
Refer to chapter B.11, “Standards Compliance and IEC Classification”. Patients traveling with the
Puritan Bennett 560 Ventilator may be required by their airline to demonstrate evidence of
compliance with the RTCA/DO-160F standard, as well as other requirements. Contact your airline
prior to travel to determine airline specific requirements and documentation.
Warning
Even though the Puritan Bennett 560 Ventilator meets current safety standards, the internal
Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to
be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the
Puritan Bennett 560 Ventilator and/or the associated Lithium-ion battery are subject to strict
transport conditions under the Dangerous Goods Regulation for air transport (IATA:
International Air Transport Association), International Maritime Dangerous Goods code for sea
and the European Agreement concerning the International Carriage of Dangerous Goods by
Road (ADR) for Europe. Private individuals who transport the device are excluded from these
regulations although for air transport some requirements apply. For air transport; the
Puritan Bennett 560 Ventilator is permitted as checked-in or carry-on baggage. Two spare
batteries per person may be taken on board as carry-on luggage only, with the prior approval of
the airline. This classification and regulatory requirements may vary depending upon the
country and mode of transport. Therefore it is recommended that users verify with the carrier /
airline as to which measures to take before the voyage.
Ventilator Overview
Target Operators
The ventilator may be operated by:
• Respiratory therapists
• Doctors
• Nurses
• Homecare providers
• Patient and patient’s families
For more details on the knowledge and skill requirements for operating the Puritan Bennett™ 560
Ventilator, refer to Appendix A Patient/Caregiver Checklist.
Warning
This ventilator must be used only under the responsibility and on the prescription of a doctor.
2.2 Contraindications
This ventilator is not for use with anesthetic gases, and is not intended for use as an emergency
transport ventilator.
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 7.8, “Locking the Control Panel,” on page 7-28).
Oxygen Enrichment
Oxygen may be supplied from an external, low pressure source, but the oxygen flow must be
limited to 15 lpm (50 kPa, 7 PSI). 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 monitoring. For more information, refer to section 6.4, “Patient Circuit,” on
page 6-6.
Warning
Users must always possess an additional breathing circuit and exhalation valve while using the
Puritan Bennett™ 560 Ventilator.
7 7
9 3
4
8 7 6 5
1 LCD Display – Displays information about the 6 Exhalation Valve Port – Nipple for providing
ventilator including patient hours and software version, piloting pressure to the exhalation valve. Controls
ventilation modes and settings, and monitored and the open-closed position of the exhalation valve.
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 7 Lateral and Front Openings – Vents that allow
and operating the ventilator, and LEDs to indicate the for air circulation to cool the ventilator’s internal
ventilator's power source, ventilation On/Off status, components. In addition, these openings function
and alarm priority level. Control functions include as sound ports for audible alarms.
turning on and off the ventilation, configuring
ventilation modes, silencing and cancelling alarms, and Warning
setting device and alarm parameters. Do not cover or obstruct these openings.
3 FIO2 Sensor Connection – Connection for FIO2 sensor 8 From Patient Port – Exhaled volume
which monitors the amount of oxygen in the patient measurements are taken from this port, through
circuit. which a portion of the exhaled gas is diverted to
the exhalation flow sensor. VTE is calculated from
this flow measurement.a
4 Patient Connection Port – Provides an outlet for the 9 Exhaled Gas Outlet – Exhalation Valve connects
gas to be delivered to the patient via the patient circuit. here.
2
3
11
10 9 8 7 6 5
10 2
9
4
8 5
7 6
3 6
1 PB560C02
6
3
4
1 General information line: 2 Ventilation settings: 3 Preferences menu access
Displays the current ventilation mode, Displays the specific ventilation line:
along with the following: parameter values for the Highlight this line and press
• Battery symbol if the device is currently selected ventilation the ENTER key to
powered by the internal battery. mode. display the Preferences
• Audio paused symbol if an Refer to chapter 3, “Operating menu.
alarm is currently inhibited. Parameters” for more Refer to manual section 7.3,
• Alarm paused symbol if an information. “Preferences Menu
alarm has been cancelled manually Parameters,” on page 7-10
and the cause of the alarm for more information.
remains.
• Apnea Alarm deactivation
• Exhalation valve symbol.
• No exhalation valve symbol.
• Absolute ABS symbol.
• Relative REL symbol.
PB560C04
1
PB560C05
1
2
3
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-8. For further information about the different ventilation modes and breath
types provided by the Puritan Bennett™ 560 Ventilator, refer to Appendix D, “Modes and Breath
Types.”
Warning
If APNEA TIME is set to a value higher than 60/Rate then the APNEA alarm will not activate.
PB560C08 PB560C09
PB560C08A PB560C09A
The ventilation parameters and setting ranges available in PSV mode are listed in Table 3-1.
Operating Parameters
Linked
Adjustment Default
Name Units Min. Value Max. Value Para-
Resolution Value meters
P Support cmH2O, Standby: 2 Standby: 55 1 15 PEEP
mbar or Valve configuration: 5 Valve configuration: 55
hPa
Leak configuration: 6 Leak configuration: 30
PEEP cmH2O, Standby: OFF 20 1 OFF P Support
m bar or Valve configuration: OFF Max P
hPa
Leak configuration: 4
Rise Time – 1 4 1 2 Insp Time
I Sens – 1P 5 1 2 –
a
E Sens % 5 (-95) 95 (-5) 5 Auto –
Backup R bpm 4 40 1 13 Min I Time
Apnea Time s 1 60 1 Auto Backup R
Vt Target ml 50 2000 10 OFF = 100 –
Min I Time s 0.1 2.8 0.1 Auto Max I Time
Max P mbar 8 55 1 PIP + 3 –
Max I Time s 0.8 3 0.1 Auto Min I Time
a. Refer to chapter 7, “Operating Procedures” for information on positive and negative E Sens settings
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 = 200 ms
Rise time = 400 ms
Rise time = 600 ms
Rise time = 800 ms
These time ranges are determined by the pressure setting required, the breath rate, and the
physiological condition of the patient.
Note:
(Refer to chapter 7.2.2, “Changing the Setup Menu Parameters” for positive and negative E Sens
settings.)
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 (E Sens) and the safety maximum inspiratory time (see above
comment on E 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 Min I Time so that the Min 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.
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 operator-selected apnea interval elapses.
The APNEA TIME adjustment range shall be 1 to 60 seconds. The ventilator shall enable the
operator to set an auto-setting which shall automatically calculate the APNEA TIME according to
the following: APNEA TIME = 60 / BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV
modes.
The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (Auto = Maximum
value between 3 seconds and 60/Backup R or AUTO=30 in CPAP mode).
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 Rate setting.
If the Apnea Alarm is set to OFF in the Preferences Menu, the Apnea Time setting will still be active.
Min and Max FIO2 settings can be set to OFF if an FIO2 sensor is not connected. Settings are
automatically restored once a sensor is reconnected.
These settings are the same for all ventilation modes.
PB560C06 PB560C07
The ventilation parameters and setting ranges available in CPAP mode are listed in Table 3-3.
Warning
The CPAP mode does not feature control cycles. Do not use this mode for ventilator-dependent
patients.
Note:
Only leak configuration is available in CPAP mode.
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 operator-selected apnea interval elapses.
The Apnea Time “AUTO” setting is 30 seconds.
Apnea Time is not available if Apnea Alarm is set to OFF in the Preferences Menu.
PB560C10 PB560C11
PB560C10A PB560C11A
The Ventilation parameters adjustable in P A/C mode are listed in Table 3-5.
Table 3-5. Ventilation Parameters in P A/C Mode Menu
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 = 200 ms
Rise time = 400 ms
Rise time = 600 ms
Rise time = 800 ms
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 is always possible
• Rise Time is established only if Insp Time 0.7 seconds
• Rise Time is established only if Insp Time 0.9 seconds
• Rise Time is established only if Insp Time 1.1 seconds.
Note:
Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.
Note:
Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.
Note:
Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.
Max Leak
The setting of a high leakage threshold enables a “HIGH LEAKAGE” alarm to be triggered in the
event the calculated leakage flow exceeds this limit. The displayed value corresponds to the mean
parasite leakage flow observed during the exhalation phase.
The ventilation parameters that are adjustable in the V A/C mode are shown in Table 3-7 on
page 3-14.
Table 3-7. Ventilation Parameters in V A/C Ventilation Mode
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 Rate.
The ratio of Vt to Insp Time (Vt / Insp Time) is [3< (Vt x 60) / (Insp Time x 1000) < 100].
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).
Note:
Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.
Sigh VT
A sigh is an increased volume of gas delivered to the patient at a set rate. i.e. every 50 breaths. The
Vt multiplied by Sigh Vt gives the amount of volume delivered to the patient during a Sigh.
Sigh Rate
Sigh Rate is the frequency with which Sigh breaths are delivered.
The Max PIP or Max 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 Min PIP and Max PIP settings is limited to a minimum of 8 mbar.
This setting is also limited by the setting of PEEP; thus, the Min PIP setting must exceed the PEEP
setting by at least 2 mbar. In addition, the Max PIP setting must exceed the PEEP setting by at least
10 mbar. A change in the PEEP level may lead to automatic changes in the Min PIP and/or Max PIP
thresholds, in order to maintain these setting differences.
PB560C14 PB560C15
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 Rate setting. Hence, Backup R is at least equal to 8 bpm
and is equal to the Rate value if Rate is greater than 8 bpm.
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that
helps the patient avoid rebreathing exhaled gas (CO2).
The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms, depending on
the preceding peak inspiratory flow. I Sens can be set to OFF.
Warning
The inspiration trigger threshold should be carefully modified 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.
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 operator-selected apnea interval elapses.
The APNEA TIME adjustment range shall be 1 to 60 seconds. The ventilator shall enable the
operator to set an auto-setting which shall automatically calculate the APNEA TIME according to
the following: APNEA TIME = 60 / BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV
modes.
The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (Auto = Maximum
value between 3 seconds and 60/Backup R or Auto = 30 if Backup R = OFF).
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 Rate setting. Hence, Backup R is at least equal to 8 bpm
and takes the Rate value if Rate is greater than 8 bpm.
Rise Time
The Rise Time during the inspiratory phase can be set in P SIMV mode and the range is 1-5. The
device is configured with a default Rise Time setting of two (2) (or a pressure rise time of 200 ms to
800 ms).
Note:
Refer to chapter 7, “Operating Procedures” for positive and negative E Sens settings.
PB560C16bis PB560C17bis
Alarm parameters that are adjustable in the V SIMV mode menu and their adjustment limits are
listed in Table 3-12.
Table 3-12. Alarm Parameters in the V SIMV Mode Menu
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 Rate.
The ratio of Vt to Insp Time (Vt / Insp Time) must be 3 lpm < (Vt *60) / (60/Rate *I/T)
Insp Time*1000) < 100 lpm.
Note:
The Backup R value applied depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and
takes the Rate value if 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).
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 Rate setting. Hence, Backup R is at least equal to 8 bpm and
becomes equal to the Rate value if Rate is greater than 8 bpm.
Note:
The Backup R value depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and becomes
equal to the Rate value if Rate is greater than 8 bpm.
Warning
The inspiration trigger threshold should be carefully modified 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.
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 operator-selected apnea interval elapses.
The APNEA TIME adjustment range shall be 1 to 60 seconds. The Ventilator shall enable the
operator to set an auto-setting which shall automatically calculate the APNEA TIME according to
the following: APNEA TIME = 60 / BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV
modes.
The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (Auto = Maximum
value between 3 seconds and 60/Backup R or Auto = 30 if Backup R = OFF).
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 Rate setting. Hence, Backup R is at least equal to 8 bpm
and takes the Rate value if Rate is greater than 8 bpm.
Ramp
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 .
Rise Time
The Rise Time during the inspiratory phase can be set in V SIMV mode and the range is 1-5. The
ventilator has a default Rise Time of 2 (or a pressure rise time of 400 ms).
Note:
Refer to chapter 7, “Operating Procedures” for positive and negative E Sens settings.
The Max PIP or Max 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”.
The difference between the Min PIP and Max PIP settings is limited to a minimum of 8 mbar. Their
settings are also limited by that of PEEP; thus, Min PIP must be greater than PEEP by at least 2 mbar
and Max PIP must be greater than PEEP by at least 10 mbar. A change in the PEEP level may lead to
automatic changes in the Min PIP and/or Max PIP thresholds so that these differences are always
maintained.
Note:
Tests conducted in a valve configuration. Results can vary according to whether the circuit is configured
with or without a valve and patient lung characteristics.
Warning
The Puritan Bennett™ 560 Ventilator can be used with an optional oxygen analyser with
minimum and maximum concentration alarms. Always measure the delivered oxygen with a
calibrated oxygen analyser (FIO2 kit) that features a minimum and maximum concentration
alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
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.
PB560C18
Figure 4-1. Ventilation Menu: Pressure Leakage Configuration Modes (CPAP, PSV S, PSV ST, PCV, P A/C)
PB560C19
Figure 4-2. Ventilation Menu: Pressure Valve Configuration Modes (PSV S, PSV ST, PCV, P A/C)
Monitored Parameters
PB560C20
Figure 4-4. Alarm Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV, P A/C)
PB560C22
Figure 4-5. Alarm Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C)
PB560C23
PB560C24
Figure 4-7. Waveform Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV, P A/C)
PB560C25
Figure 4-8. Waveform Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C)
PB560C26
Monitored parameter values are updated every two breath cycles and are displayed in the form of
inserts, as shown in Figure 4-10.
PB560C26A
1
PB560C26
2
3
1 Parameter name
3 Unit of measure
If the monitored value for a parameter is not applicable or unavailable, the value is replaced by a
hyphen “–” as shown in Figure 4-11.
PB560C27
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 4-12).
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.
PB560C28 PB560C29
PB560C30
The PIP value reached during a cycle is represented by a line at the top of the bargraph
(Figure 4-13, 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 (Figure 4-13, item 2).
PB560C31
1 4 1. Ventilation Mode
2. Pressure over last two
2
cycles1
3. Maximum Flow over
last two cycles
4. Frozen waveform
3 symbol
5. Inspiratory trigger
symbol
1. Pressure and flow scales are
5 adjusted over three cycles,
but only two cycles are
displayed.
Waveform tracing can be frozen at any time, which enables the analysis of pressure and flow
waveforms, while continuing patient ventilation.
PB560C33
Note:
The values displayed in the Ventilation Report are reinitalised when the software is updated or the patient
counter is reset to zero.
Leak
When ventilating with a leak configuration circuit, it is the average parasitic leak during each cycle
and over the past 24 hour period. When ventilating with a single limb circuit there is no average
leak.
AI – Apnea Index
The Apnea index is average number of apnea events per hour of ventilation. It is based on the
Apnea Alarm.
Machine
Total time in hours that the ventilator has been switched on since manufacture.
Patient
Total time in hours and minutes that the current patient has been ventilated.
Warning
Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
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.
The alarms or faults generated by your Puritan Bennett™ 560 Ventilator are classified into two
categories:
• Ventilation (or utilisation) alarms
• Technical faults
Some of the ventilator alarms are adjustable, depending on ventilation modes (refer to chapter 3,
“Operating Parameters”). Automatic, non-adjustable alarms also exist to create a safety net for
safer 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 authorised and trained technicians may consult the maintenance menu (refer
to the Puritan Bennett 560 Service Manual).
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
Note:
There are currently no Low Priority (LP) Alarms.
Alarms and Troubleshooting
Note:
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).
ALARM INDICATORS
PB560C34 PB560C35
ALARM MESSAGES
Figure 5-1. Alarm Displays
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.
PB560C36
Note:
When no alarm has been activated, “NO DATA” is displayed on the screen (see graphic below).
PB560C43
For more information on the “USER’S CLEAR ALERTS” line, refer to section 5.6, “Re-activating
Alarms,” on page 5-6.
Note:
Only qualified service personnel may access all alarms and events recorded by the ventilator. Qualified
personnel should refer to the Puritan Bennett™ 560 Service Manual for further information.
PB560C38
If several alarms are activated at the same time, pressing the ALARM CONTROL key affects
all current alarms.
Note:
If a key is stuck or held down for 45 seconds a keypad alarm will occur.
Some alarms are not automatically cancelled when the condition causing the alarm clears e.g.
HIGH PRESSURE. Some alarms can be paused manually even if the cause(s) of their activation
remain(s).
PB560C40
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. The
High Pressure alarm must be manually reset. Refer to section 5.7, “Overview of Alarms,” on page
5-7.
To manually reset the High Pressure Alarm, proceed as follows:
Press the ALARM CONTROL key twice.
• The visual alarms will be reset.
PB560C39
3. Press the ENTER key, to confirm access to the “Alarm Logs” menu.
4. Press the UP key to position the cursor on the “USER’S CLEAR ALERTS” line. Refer to the
following graphic:
PB560C42
5. Press the ENTER key for at least three (3) seconds. The following events occur:
• A “beep” sounds.
• 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.
Note:
The message: “*IF PERSISTS RESTART/SRVC” will occur only if the alarm condition continues for longer
than 30 seconds.
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
Cut-off of the AC (mains) power supply.
Alarm activation occurs:
• After 5 seconds if ventilation is
stopped
AC POWER
• At the start of a ventilation cycle MP Yes Yes
DISCONNECTION
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 Yes –
APNEA PSV, CPAP, P SIMV and V SIMV modes. MP Yes except for
Automatically clears itself after two CPAP
successive patient breaths.
Ventilator has detected an internal
BATTERY FAULT1 battery fault.
MP Yes No
RESTART/SRVC Consequence: the internal battery is
disabled from use.
BATTERY FAULT2 No internal battery detected.
MP Yes No
RESTART/SRVC
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
Failure of one calibration point of the
internal exhaled flow sensor.
CALIBRATION FAIL MP Yes Yes
Consequence: failed calibration point is
replaced by the default point.
CHECK BATTERY Internal battery charging failure.
CHARGE Consequence: charging of the internal MP Yes Yes
IF PERSISTS battery impossible.
RESTART/SRVC
Inspired tidal volume during exhalation
CHECK EXH VALVE*
< 20% of Inspired tidal volume and
*IF PERSISTS Inspired tidal volume > 20 mL. HP Yes No
RESTART/SRVC
Exhalation valve obstructed.
Internal ventilation fault related to
CHECK EXH VALVE
exhalation valve detection sensor. HP Yes Yes
PRESSURE (pressure sensor)
CHECK FIO2 FIO2 measurement is less than 18%.
HP Yes No
SENSOR Recalibrate or change FIO2 sensor.
1. Loss of signal from the proximal
pressure sensor
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
CONTROLLED The ventilator is delivering apnea
NA No No
CYCLES ventilation at set back up rate.
HIGH / LOW
BATTERY TEMP* Battery temperature out of tolerance.
MP Yes Yes
*IF PERSISTS Consequence: battery charging stops.
RESTART/SRVC
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
The level of oxygen delivered by the
HIGH FIO2 ventilator exceeds the Max FIO2 level MP Yes No
set.
HIGH INT TEMP Device internal ambient temperature out
COOL VENT* of tolerance range.
MP Yes Yes
*IF PERSISTS
RESTART/SRVC
The LEAK estimated by the ventilator
HIGH LEAKAGE MP Yes No
exceeds the Max LEAK alarm threshold.
• In V A/C or V SIMV modes, if Inspiratory
Pressure is higher than Max PIP during
three consecutive cycles.
or
• In PSV, CPAP, P A/C, or P SIMV modes, HP
if Inspiratory Pressure is higher than Note:
(P Support or P Control + PEEP) + When alarm
5 mbar up to 29 mbar or + 10 mbar condition No
over 30 mbar during three consecutive clears, alarm (The visual
cycles. priority portion of
HIGH PRESSURE Yes
or indicator the alarm
• In PSV or CPAP mode and P Support is must be may be
set to off, if Inspiratory Pressure is higher manually paused)
than PEEP + 10 mbar during three reset by
consecutive cycles. pressing the
Alarm activation occurs: key.
• After three consecutive breaths.
Consequence:
• Switch to exhalation phase.
Rate measured greater than Max Rtot
set during three consecutive breaths.
HIGH RATE MP Yes No
Alarm activation occurs:
• After three consecutive breaths.
Expired tidal volume greater than Max
VTE set during three consecutive breaths
HIGH VTE (in double limb setup). MP Yes No
Alarm activation occurs:
• After three consecutive breaths.
Inspired tidal volume greater than Max
VTI set during three consecutive breaths
in PSV, CPAP, P A/C, P SIMV, and V SIMV
HIGH VTI modes. HP Yes No
Alarm activation occurs:
• After three consecutive breaths.
Inspiratory flow is constant ( 1 lpm)
INSP FLOW with normal turbine temperature and
HP Yes No
RESTART/SRVC speed conditions. Contact your service
representative for assistance.
INTENTIONAL VENT Ventilation has been stopped voluntarily
HP Yes Yes
STOP by the caregiver or patient.
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
Alarm activation occurs if conditions
remain for the maximum time between:
• disconnection time and 60/R-Rate in
P A/C and V A/C mode
• disconnection time and (Apnea time
+2 sec) in CPAP and PSV mode
• disconnection time and (60/R-Rate +
PATIENT Insp time) in P SIMV and V SIMV
DISCONNECTION* mode.
HP Yes No
*IF PERSISTS
If the flow is greater than 130 lpm
RESTART/SRVC during the inspiratory phase.
In V A/C and V SIMV modes, if patient
pressure is lower than Min PIP.
In PSV, CPAP, P A/C modes and P SIMV
if patient pressure is lower than
(P Support + PEEP) - 20% or
(P Control + PEEP) - 20%.
POWER FAULT Detection of a fault in the electrical
MP Yes Yes
RESTART/SRVC power supply system.
Audio Alarm
Alarm Message Cause/Ventilator Response Priority Paused Paused
Avail. Avail.
Turbine speed too low and temperature
TURB OVERHEAT too high.
HP No No
RESTART/SRVC Consequence: ventilation stops
immediately and O2 supply stops.
UNKNOWN The internal battery is not recognised as
MP Yes No
BATTERY a Puritan Bennett™ product battery.
5.8 Troubleshooting
Warning
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 and avoid the possibility of physical injury to personnel or damage
to the ventilator, only personnel authorised and qualified by Covidien should attempt to service
or make authorised modifications to the Puritan Bennett 560 Ventilator.
5.8.1 Alarms
Table 5-2 offers a guide to the most likely ventilator alarms, possible reasons for the alarms, and
corrective 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.
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.
Note:
The ventilator screen must be unlocked before setting and parameters can be changed.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
Cancel the alarm then check the supply
cable and/or the effective availability of a
voltage on the AC power (“mains”) port.
AC (“mains”) power source cut off.
Cancel the alarm then check the power
cable availability of a voltage on the AC
AC POWER
DISCONNECTION power (“mains”) outlet.
Starting with 12 – 30 VDC external power
Cancel the alarm.
supply.
Replace the ventilator and call for the
Current-limiting fuse of the device blown.
maintenance technician.
Ensure the patient is breathing and adjust
Patient’s breathing effort less than the
the inspiratory setting appropriately based
Sensitivity control setting.
on patient’s respiratory needs.
Examine the patient for breathing effort and
stimulate if necessary.
Patient apnea. If patient status has changed adjust the
APNEA
ventilator settings based on patient’s
respiratory needs.
Have a qualified technician replace the
Defective sensors. defective component(s) and call your
customer service representative.
Restart ventilator to see if alarm clears.
BATTERY FAULT1 Battery problem that prevents it from
If not, replace the ventilator and call your
RESTART/SRVC operating.
customer service representative.
Restart ventilator to see if alarm clears.
BATTERY FAULT2 Internal battery missing or not detected. If not, replace the ventilator and call your
RESTART/SRVC customer service representative.
Defective operation of the buzzers. Restart ventilator to see if alarm clears.
BUZZER FAULT1 If not, replace the ventilator and call your
RESTART/SRVC Consequence: no audible tone when an
alarm is activated. customer service representative.
Ensure that the protective cover over the I/O
switch located on the rear of the device is
Internal technical problem that prevents intact and functioning properly. This cover
BUZZER FAULT2 the very high priority “POWER SUPPLY helps prevent accidental pressing of the I/O
RESTART/SRVC switch and stoppage of the ventilation.
LOSS” alarm from triggering.
Ensure that the device is stabilised.
Call your customer service representative.
BUZZER FAULT3 Restart ventilator to see if alarm clears.
Internal technical problem that prevents
RESTART/SRVC If not, replace the ventilator and call your
the battery from correctly charging.
customer service representative.
Connect the ventilator to AC power and
switch on the device using the on/off at the
Internal technical problem that prevents rear of the ventilator (I/O). Leave to charge
BUZZER FAULT4 the battery warning buzzer from sounding for at least 15 minutes.
RESTART/SRVC
POWER SUPPLY LOSS alarm. If persists restart ventilator to see if alarm
clears. If not, replace the ventilator and call
your customer service representative.
Connect the ventilator to AC power and
Buzzer battery is too low to sound POWER switch on the device using the on/off at the
BUZZER LOW BATTERY SUPPLY LOSS alarm. rear of the ventilator (I/O). Leave to charge
for at least 15 minutes.
An FIO2 sensor is detected and has not
CALIBRATE FIO2 Calibrate FIO2 sensor.
been calibrated.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
Restart calibration.
Too large a difference between a There may be a leak in the circuit. Ensure an
calibration point and its tolerance range. approved circuit is in use (refer to circuit
documentation).
Incorrect circuit type selected in the Verify the circuit selection in the Preferences
Preferences menu. matches the circuit in use.
CALIBRATION FAIL Exhalation block defective or not properly Reset alarm message and ensure all
aligned. connections are secure, verify circuit
integrity, and verify the exhalation block is
properly seated.
Defective exhalation flow sensor. Have a qualified technician replace the
defective component(s) and call your
customer service representative.
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
CHECK BATTERY Battery charging impossible.
CHARGE 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.
Obstruction or abnormal damage of the Clean or replace the exhalation valve and/or
exhalation valve. its control tube.
Remove moisture from exhalation block and
valve.
Excessive moisture in the exhalation block.
Verify exhalation valve is seated properly.
CHECK Reduce temperature of the humidifier.
EXH VALVE
Reconnect the valve or replace the
Defective connection or defective
exhalation valve and/or the exhalation valve
exhalation valve tubing.
pilot pressure tube.
Defective inspiratory flow sensor. Have a qualified technician replace the
defective component(s) and call your
customer service representative.
The exhalation valve may not be detected Restart ventilator to see if alarm clears.
by the ventilator when ventilation is If not, replace the ventilator and call your
CHECK EXH VALVE started. customer service representative.
PRESSURE
Or the exhalation valve may be falsely
detected when ventilation is started.
Check that FIO2 sensor is properly
connected or
CHECK FIO2 SENSOR FIO2 measured is less than 18%.
Recalibrate FIO2 sensor or
Replace FIO2 sensor.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
No connection of the proximal pressure
Reconnect the proximal pressure line.
tube when ventilation starts.
Reconnect the connection line or replace it
if obstructed.
CHECK PROXIMAL Proximal pressure line disconnected or Check for moisture or occlusion of the
LINE1* obstructed. proximal line.
*IF PERSISTS Reduce humidifier temperature.
RESTART/SRVC Switch to a heated wire circuit.
Restart ventilator to see if alarm clears.
Defective proximal pressure sensor or If not, have a qualified technician replace
internal leak of the machine. the defective component(s) and call your
customer service representative.
Nurse Call or remote alarm system is Connect the Nurse Call or remote alarm
disconnected. cable to the ventilator.
CHECK REMOTE
ALARM Carefully monitor the patient to detect
Relay control voltage problem. possible alarm triggering and call for the
maintenance technician.
Check and adjust the prescribed
Loss of memorised parameters.
parameters, if necessary.
CHECK SETTINGS
Check and adjust the prescribed
Software versions have changed.
parameters, if necessary.
The ventilation settings are not compatible Connect exhalation valve
with the type of patient circuit used. Decrease PIP to less than 30 mbar in
No exhalation valve connected with PEEP absolute pressure.
set to less than 4 mbar Increase PEEP to more than 3 mbar.
CONNECT VALVE or
OR CHANGE PRESS Note:
PIP set to more than 30 mbar when
relative pressure is set to OFF. Always consult the clinician before changing
PEEP, FIO2, pressure, volume or Rate
settings.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
DEVICE FAULT9 If patient has been disconnected, reconnect
IF PERSISTS patient to reset the fault.
POST RAM Error. RAM Read/Write does
RESTART/SRVC not match memory setting. If persists restart ventilator to see if alarm
clears. If not, replace the ventilator and call
your customer service representative.
DEVICE FAULT10 POST FLASH Checksum Error. Startup Restart ventilator to see if alarm clears.
IF PERSISTS FLASH computed checksum does not If not, replace the ventilator and call your
RESTART/SRVC match memory setting. customer service representative.
Note:
Always consult the clinician before changing
PEEP, FIO2, pressure, volume or Rate
settings.
Note:
E sensitivity setting not properly adjusted Always consult the clinician before changing
PEEP, FIO2, pressure, volume or Rate
settings.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
If oxygen is to be delivered to the patient,
There is no FIO2 sensor and FIO2 alarms connect FIO2 sensor.
FIO2 SENSOR MISSING are active. If no oxygen is to be delivered to the
patient, deactivate FIO2 alarms.
Check the level of oxygen corresponds to
the patient’s prescription or
Increase the FIO2 alarm threshold.
The level of oxygen being delivered to the
HIGH FIO2 patient is higher than the Max FIO2 limit Note:
set.
Always consult the clinician before changing
PEEP, FIO2, pressure, volume or Rate
settings.
Note:
Ensure that you are operating the ventilator
within the proper temperature range
(refer to Appendix B, “Specifications”).
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 41 °C
(106 °F). If in doubt, replace the ventilator.
Defective internal temperature probe or Replace the ventilator and call your
any other technical anomaly. customer service representative.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
Warning
Caution
Ensure that ventilator is being used
according to the operating instructions
found in Appendix B, “Specifications”.
Note:
Always consult the clinician before changing
Adjustment of the Max VTE level too low. PEEP, FIO2, pressure, volume or Rate
settings.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
Note:
Adjustment of the Max VTI level too low Always consult the clinician before changing
(for PSV, CPAP, P A/C, P SIMV and V SIMV PEEP, FIO2, pressure, volume or Rate
modes). settings.
Note:
Adjustment of the pressure level too high Always consult the clinician before changing
HIGH VTI for the volume required (for PSV, CPAP, PEEP, FIO2, pressure, volume or Rate
P A/C, P SIMV and V SIMV modes). settings.
Note:
Always consult the clinician before changing
Adjustment of Max PIP too low (only for
PEEP, FIO2, pressure, volume or Rate
V A/C and V SIMV modes).
settings.
INSP FLOW Inspiratory flow is constant (1 lpm) with Restart ventilator to see if alarm clears.
normal turbine temperature and speed If not, replace the ventilator and call your
RESTART/SRVC conditions. customer service representative.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
The user / caregiver has stopped Check that the ventilation was switched off
ventilation using the VENTILATION on purpose.
INTENTIONAL ON/OFF key. Ventilation is in stand-
VENT STOP This alarm can be deactivated. Refer to
by. chapter 7.2.2, “Changing the Setup Menu
Parameters”.
Press and release keys in the normal,
Pressing a key for more than 45 seconds. prescribed manner. Do not press keys for 45
seconds or more.
KEYPAD FAULT If unsuccessful in releasing the stuck key(s),
RESTART/SRVC restart ventilator to see if alarm clears. If
A key on the keyboard is stuck. not, 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
Internal battery capacity is less than DC power source.
LOW BATTERY 30 min. (or 8%) – battery operation
overextended. Reminder: the internal battery can be
charged only when the ventilator is
connected to an AC power supply.
Note:
Always consult the clinician before changing
PEEP, FIO2, pressure, volume or Rate
The level of oxygen being delivered to the settings.
LOW FIO2 patient is below the Min FIO2 limit set.
Check the level of oxygen corresponds to
the patient’s prescription or
Decrease the FIO2 alarm threshold.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
Clean, unblock, and/or properly connect the
Patient circuit obstructed.
patient circuit.
Check and properly connect the patient
circuit connections.
Leak in the patient circuit. 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
Exhalation block missing or disconnected.
exhalation flow sensor (see section 10.1,
“Calibrating the Exhalation Flow Sensor,”
on page 10-1). Call your customer service
representative.
Set the Min VTE alarm limit to OFF.
LOW VTE
Adjustment of a Min VTE threshold when Warning
the patient circuit is in a single-limb
configuration. If exhaled tidal volume monitoring is
required, use the double-limb circuit.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
Adjustment of Min PIP too high. Decrease the Min PIP threshold.
Leak or loose connection in the patient Check the patient circuit connections to the
circuit. ventilator; examine all connections for
Circuit disconnection from patient or leakage and tightness.
PATIENT ventilator. Replace the patient circuit if necessary.
DISCONNECTION Check Min PIP alarm setting.
Inspiratory flow exceeds 130 LPM.
*IF PERSISTS Adjust Apnea alarm setting.
RESTART/SRVC Inappropriate patient circuit. Replace the patient circuit.
Restart ventilator to see if alarm clears.
Defective internal circuits of the machine If not, have a qualified technician replace
or pressure sensor. the defective component(s) or call your
customer service representative.
OCCLUSION
CHECK CIRCUIT Clean, unblock, and/or properly connect the
Patient circuit obstructed.
patient circuit.
*IF PERSISTS
RESTART/SRVC
A non-vented configuration is being used
Replace the non-vented circuit with a
or the built-in leak in the mask or in the
vented one. Clean, unblock the mask or the
circuit may be obstructed or insufficient
OCCLUSION circuit of the vented system or switch to a
for the settings. Note that a high
CHECK CIRCUIT vented system with a larger leak
respiratory rate or backup rate may not
configuration. Try to reduce patient’s
sufficiently flush out CO2 in some vented
backup rate if possible.
pediatric masks.
Restart ventilator to see if alarm clears.
POWER FAULT Internal problem in the electrical power
If not, replace the ventilator and call your
RESTART/SRVC supply.
customer service representative.
Press the I/O switch to restore electrical
power to the ventilator and allow
ventilation to continue.
Electrical power supply cut off by the main To stop ventilation, press the VENTILATION
switch when ventilation is in progress. ON/OFF key for three seconds, then release
POWER SUPPLY LOSS it. Press the VENTILATION ON/OFF key again
to confirm stop. (refer to chapter 7,
(without message) “Operating Procedures”).
Immediately connect the ventilator to an
The internal battery that supplies the AC power outlet or an external DC power
ventilator is entirely discharged. source; otherwise, use an alternate device
to ventilate the patient.
PRES SENS FLT1 Restart ventilator to see if alarm clears.
RESTART/SRVC If not, have a qualified technician replace
Defective internal pressure sensor.
the defective component(s) and call your
customer service representative.
PROX SENS FLT2 Restart ventilator to see if alarm clears.
RESTART/SRVC Defective proximal pressure sensor or If not, have a qualified technician replace
internal leak of the machine. the defective component(s) and call your
customer service representative.
Remove exhalation valve to start ventilation
The ventilation settings are not compatible with less than 5 mbar of difference between
REMOVE VALVE OR PEEP and PIP or
CHANGE PRES with the type of patient circuit used.
Increase the difference between PEEP and
PIP to a minimum of 5 mbar.
REMOVE VALVE The ventilation settings are not compatible Remove exhalation valve to start CPAP
CPAP MODE with the type of patient circuit used. ventilation.
Alarm Message or Possible Reason(s) For The Alarm Event Corrective Action(s)
Symptom
SOFTWARE VERSION
Incorrect software version detected. Call your customer service representative.
ERROR
Ensure lateral and front openings are not
obstructed.
TURB OVERHEAT Turbine overheated because of blockage Check air inlet filter.
RESTART/SRVC during operation. Restart ventilator to see if alarm clears. If
not, replace the ventilator and call your
customer service representative.
Internal battery not recognised as a
UNKNOWN BATTERY Call your customer service representative.
Puritan Bennett™ product battery.
VALVE MISSING The ventilation settings are not compatible Connect exhalation valve.
CONNECT VALVE with the type of patient circuit used.
Restart ventilator to see if alarm clears. If
VTI NOT REACHED Defective inspiratory flow sensor or
not, replace the defective device(s) and have
*IF PERSISTS internal leak of the machine.
a skilled technician check them.
RESTART/SRVC
I time is not long enough to deliver set VT. Increase I time or decrease VT.
Note:
Buzzer 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.
Warning
Before operating the ventilator, read, understand, and strictly follow the information contained
in chapter 1, “Safety Information”.
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 highly recommended. Refer
to chapter 9, “Cleaning”.
Warning
The operator should connect the ventilator to an AC power source whenever available, for safer
operation.
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 can 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.
If the ambient temperature where the device is operated is greater than 35 °C (95 °F), the flow
supplied at the device outlet may exceed 41 °C (106 °F). 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.
To reduce the risk of 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.
Never connect your ventilator to an electrical outlet controlled by a wall switch because the
power may be inadvertently turned off.
Installation and Assembly
Even if the “INTERNAL BATTERY” charging indicator is off, charging of the battery may
sometimes be incomplete if the ambient temperature is above 40 °C (104 °F) because of the
battery’s internal heat safety device.
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.
The Puritan Bennett™ 560 Ventilatorrequires 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 / EN 60601-1-2 standard, may affect its operation.
Refer to section B.10, “Manufacturer’s Declaration,” on page B-10.
The ventilator must not use, nor be connected to, any anti-static or electrically conductive
hoses, tubing, or conduits.
To prevent accidental disconnection of the AC power cable, use the power cable holder
(Figure 6-1, item 1) that is inserted into the notch (Figure 6-1, item 2) of the battery cover:
AC Power Cable Holder.
Figure 6-2. Inserting the Power Cable Holder Into the Notch
2. Push the AC power cable into the power cable holder (Figure 6-2, item 2).
3. Connect the female end of the ventilator’s AC power cable to the AC connector on the back of
the ventilator.
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.
• The indicator flashes while the battery charges and then turns off when the 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 indicators are illuminated at the same time is when the ventilator is
connected to an AC supply and the battery is charging (indicator is flashing).
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.
Note:
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 (Figure 6-5, item 2). The DC power cable is optional; refer to
Appendix H, “Parts and Accessories”, for more information. It is possible to use the DC auxiliary port
(cigarette lighter) in a car as a power source as well.
1 2
Warning
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.
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
Figure 6-4).
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 “DC POWER DISCONNECTION“ alarm signals an automatic switch to the internal battery in
case the external DC power source fails or becomes disconnected.
To connect a single limb circuit with an exhalation valve: (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 2) to the bacteria filter (item 1).
4. Attach the other end of the circuit tubing (item 2) to the inlet port of the humidifier (item 3).
5. Place a water trap (item 4) 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 as close as possible to the patient.
7. Connect one end of the proximal pressure tubing (item 7) 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 6) to the exhalation valve port on the
exhalation valve (item 5) and the other end onto the ventilator exhalation valve port (item 9).
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).
9
8 10
1
2
7
6
4
5
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.
10 14
9 13
1
8
12 4
7 2
5 3
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.
Inhalation Port
Exhalation
Valve Tube
Proximal Pressure
Tube
Figure 6-9. Close-up of Exhalation Valve Tube and Proximal Pressure Tube
Figure 6-9 shows details of the connections of the proximal pressure tube (Figure 6-8, item 6) and
the exhalation valve tube (Figure 6-8, item 8).
5
3
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 PATIENT DISCONNECTION triggering threshold by doing one of the
following: set a Max VTI alarm limit for pressure modes or a Min VTE alarm limit for all ventilation
modes if using a dual limb 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 exhalation block for a double limb circuit.
Warning
When using non-invasive ventilation (NIV), without an exhalation valve, use a vented nose or
face mask or a non vented combined with a leak accessory. When using non-invasive ventilation
(NIV), with an exhalation valve, use a non vented mask.
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 PATIENT DISCONNECTION 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, HMEs etc) must be as
low as possible.
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.
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.
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. If
necessary, replace the filter before the recommended replacement period is over (see
chapter 10, “Routine Maintenance”). This is particularly important when the ventilator is
installed on a wheelchair, because environmental conditions may cause the filter to become
dirty more rapidly.
Warning
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.
Bacteria Filter
It is highly recommended that you install a bacteria filter (see Figure 6-12) on both single and
double limb circuits. In a double limb configuration, two bacteria filters are used: one at the
TO PATIENT port, and the other at the FROM PATIENT port.
• Connected to the TO PATIENT port:
This filter protects the ventilator from contamination by the patient (primarily, rebreathed gas).
Refer to Figure 6-8, item 1.
• Connected to the FROM PATIENT port:
This filter protects the internal exhalation flow sensor from the gases exhaled by the patient.
Refer to Figure 6-8, item 10.
Refer to the manufacturer’s instructions for more information about the use and maintenance of
the bacteria filter(s).
6.6 Humidifier
The humidifier (Figure 6-13) adds moisture (water vapour) and warms the gas in the patient circuit.
It is inserted into the patient circuit between the main outlet and the patient (refer to Figure 6-7
and Figure 6-8).
Warning
During invasive ventilation (when an artificial airway bypasses the patient’s upper respiratory
system), the patient’s upper respiratory system cannot humidify the incoming gas. For this
reason, the use of a humidifier, to minimise drying of the patient’s airways and subsequent
irritation and discomfort, must be used.
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 gas delivered
to the patient. Gas 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.
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
sterilising the humidifier.
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.
1 2
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”.
Warning
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 exhalation flow sensor be recalibrated before the
exhalation block is used. Refer to section 10.1, “Calibrating the Exhalation Flow Sensor,” on
page 10-1).
6.8 Oxygen
Warning
The ventilator must not be used with flammable anesthetic substances.
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 gas. 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 3.7, “FIO2 For Various
Oxygen and Ventilator Settings”).
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 psi (50 kPa) or a flow of
15 lpm. Refer to Table B-8 on page B-3 for volume and sensitivity tolerances.
The Puritan Bennett™ 560 Ventilatorcan be used with an optional oxygen analyser with
minimum and maximum concentration alarms. Always measure the delivered oxygen with a
calibrated oxygen analyser (FIO2 kit) that features a minimum and maximum concentration
alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
A connector (Figure 6-15, 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).
3 4
Warning
Before connecting the oxygen supply, ensure that the stud on the oxygen connector
(Figure 6-15, item 3) is protruding outwards.
Inspect the oxygen coupler (Figure 6-16, 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.
2 3
4 5
Note:
Ensure the oxygen source is turned off prior to placing the ventilator in Standby or turning off the
ventilator.
Warning
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.
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. Circulate fresh air into the room to bring the oxygen level down to normal.
To prevent any interference with the internal sensors of the ventilator, do not install a
humidifier upstream of the ventilator.
2
1
3
The Dual Bag accessory consists of a carrying bag that allows the Puritan Bennett™ 560
Ventilatorto be both mounted onto a wheelchair or carried as a backpack (see Figure 6-19).
Refer to the Dual Bag’s instructions for further information.
1
2
Warning
Before using the Nurse Call system, ensure that its connections are secure and it operates
properly. For more information, contact Covidien.
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.
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).
PB560C50
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.
PB560C51
By default, the starting ventilation mode is the last one used, the settings being 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 saved; otherwise the machine will operate on
default parameter values.
Note:
When a parameter contains several setup fields (such as Date and Time) press ENTER to move
from one field to the next.
If you do not confirm a change by pressing ENTER before seven (7) seconds elapse, the
ventilator restores the setup field’s previous value.
Machine Hours:
The counter records the total ventilation time in hours (to the nearest hour) since manufacture.
Note:
The machine hour meter is reset when the CPU board is changed.
Language
The language can be set here. All messages and denominations are automatically displayed in the
selected language. The languages available are:
Table 7-1. Languages
Turkish Dutch –
Swedish Korean –
Date
The current date can be set here. The date is displayed in the format: DD MMM YYYY.
Time
The current time can be set here. The time is displayed in the format: HH: MM: SS.
Cycling Mode
The cycling mode determines the duration of inspiratory time in P A/C and V A/C. It can be set to
either I:E or I/T and enables the operator to set the duration of inspiratory and exhalation phases.
The two cycling modes represent the relationship between inspiration time to exhalation time as
follows:
1. I/T: Inspiratory time (Ti) as a percentage of the total breath cycle time (Ti + Te).
I/T (%) = [Ti / (Ti+Te)] x 100
2. I:E The inspiration time (Ti) to exhalation time (Te) ratio.
I:E = 1/(Te /Ti)
In P A/C and V A/C modes, the cycling ratio changes based on patient inspiration; however, the
inspiratory time remains constant and corresponds to the rate and cycling ratio settings.
Note:
When adjusting I:E or I/T ratio, the corresponding calculated Ti is displayed below the parameter zoom in
the monitoring and information window.
Pressure Unit
The unit of pressure can be set here. It can be displayed as mbar, cmH2O or hPa.
E Sens Settings
E Sens enables the operator to adjust the sensitivity of the expiratory trigger in pressure support
breaths in PSV, P SIMV and V SIMV modes which will cycle the breath into the expiratory phase.
During a Pressure Support inspiration the delivered flow will reach a peak value and then begin to
decelerate toward zero. The E Sens setting allows the operator to set the flow value, as a
percentage of peak flow, that will cycle the breath to exhalation.The E Sens setting can be set to
either POSITIVE or NEGATIVE.
If set to POSITIVE, E Sens is based on the percentage of inspiratory peak flow. If set to NEGATIVE,
E Sens is based on the percentage of inspiratory peak flow by which the flow must decrease before
exhalation is declared.
Patient Hours
The value of this parameter is equal to the total number of hours that the patient has been
ventilated.
Note:
Resetting the patient hours will also reset the trends stored in the device memory in preparation for a new
patient.
2. Press ENTER .
• The cursor is placed on the “Reset Hours” line: OFF“.
3. Press ENTER .
• “OFF“ flashes.
4. Press UP or DOWN to change the “OFF” message to “YES“, as shown in the
following graphic:
5. Press ENTER .
• “YES“ is displayed continuously.
• A long “beep“ sounds.
• The patient counter display indicates 00000h, as shown in the following graphic:
6. Press UP or DOWN .
• The display indicates “Reset Hours: OFF“, as shown in the following graphic:
Maintenance
This option is reserved for maintenance operators qualified by Covidien to ensure correct
maintenance and operation of the device. For information on using the Maintenance option, refer
to the Puritan Bennett™ 560 Ventilator Service Manual.
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
PB560C53
PB560C101 PB560C100
7.3.2 Backlight
To set the Backlight:
1. Select the Backlight parameter on the display.
Note:
If running the ventilator on its internal battery or on an external battery, we recommend keeping the
backlight setting to OFF to reduce power consumption.
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:
1. Select the Contrast parameter on the display.
2. Set the Contrast level:
a. To increase the contrast, press UP . This change can be observe as the cursor moves to
the right:
The buzzer activates and increases in sound level as the setting increases.
b. To decrease the sound level of alarms, press DOWN . This change can be observed as
the cursor moves to the left:
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 3 metres
(9.84 feet), which corresponds to the lowest possible volume setting. The alarm sound level range
is 65 dB(A) to 85dB(A) measured at 1 metre (3.28 feet). If a high priority alarm is not paused within
60 seconds of activation, the sound level automatically raises to 85 dBA regardless of the original
setting.
The default setting for Alarm Volume corresponds to a level of 75 dB(A).
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.
4.
Warning
The Apnea Alarm should be set to YES for ventilator dependant patients.
Note:
This activates / disactivates the Apnea alarm but not the Apnea Time Setting. The Apnea Time
Setting can be set in the Ventilation Menu.
Note:
Values set in the ventilation mode may supercede disconnection alarm values. Refer to chapter 5, “Alarms
and Troubleshooting”.
Note:
The menu is displayed for five minutes then screen reverts to the Preferences Menu.
2. Press ENTER .
• The cursor changes to: .
• The mode name flashes.
If the ventilation mode change is not confirmed by pressing ENTER before seven (7) seconds
elapse, the ventilator restores the previous mode.
2. Press ENTER .
• The cursor changes to: .
• The mode name flashes.
3. Press UP or DOWN until the required mode is displayed.
4. Press ENTER 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).
PB560C57
1 2
3
4
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.
PB560C58
It is not mandatory to change modes during ventilation (see steps 6 and 7, above). 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 I Sens setting is adjusted in
the inactive V A/C mode.
PB560C59
If an alarm is triggered during the setting of an inactive mode, its message is displayed in the alarm
message display.
When the menu of an inactive mode is displayed and no changes are made by the user on the
keyboard within 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.
3. Press UP or DOWN to select the value desired for the parameter (continuing to
press on these keys speeds up the progression of values displayed).
4. Press ENTER 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 confirmed by pressing ENTER before seven (7) seconds
elapse, the ventilator restores the parameter’s previous value.
PB560C61
Note:
• Adjustable alarms should not be systematically cancelled, 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.
2
PB560C62
1
3
1 2
PB560C62
Warning
The level of inspiratory resistance of the circuit and accessories (bacteria filter, humidifier) must
be as low as possible. Settings—particularly the PATIENT DISCONNECTION alarm, maximum
inspired volume (Max VTI), and minimum inspired volume (Min VTI) settings—must be
periodically adjusted according to changes in the patient circuit resistance—especially when
filters are replaced.
Adjustable alarms should not be systematically cancelled; instead, they should be adjusted
according to the needs and condition of the patient.
PB560C70
In case of high priority alarm activation the ventilator will automatically display the alarm page. To
return to the USB Menu, press the MENU key.
PB560C71 PB560C72
The message “TRANSFER IN PROGRESS... REMAINING TIME” is displayed during the transfer time.
Other functions of the USB memory device are not available during continuous recording,
If the memory capacity on the USB memory device is insufficient the message “TRANSFER NOT ALLOWED -
USB CAPACITY INSUFFICIENT” is displayed and data transfer is not allowed. Delete the data on the USB
memory device before restarting data transfer. Refer to deletion process. (Refer to chapter 7.7.5, “Erase Data
from the USB Memory Device”.)
In case of USB memory device disconnection or transfer error, the message “TRANSFER ERROR - USB
DISCONNECTION” or “TRANSFER ERROR - TECHNICAL PROBLEM” is displayed. In this case restart the
transfer process. If the problem persists contact your technical service.
PB560C73 PB560C74
Table 7-3. Time taken to transfer trends data from the ventilator to a USB memory device
Note:
The message “TRANSFER IN PROGRESS... REMAINING TIME” is displayed during the transfer time.
Other USB memory device functions are available during transfer of trends.
If the memory capacity on the USB memory device is insufficient the message “TRANSFER NOT ALLOWED -
USB CAPACITY INSUFFICIENT” is displayed and data transfer is not allowed. Delete the data on the USB
memory device before restarting data transfer. Refer to deletion process. (Refer to chapter 7.7.5, “Erase Data
from the USB Memory Device”.)
In case of USB memory device disconnection or transfer error, the message “TRANSFER ERROR - USB
DISCONNECTION” or “TRANSFER ERROR - TECHNICAL PROBLEM” is displayed. In this case restart the
transfer process. If the problem persists contact your technical service.
PB560C75 PB560C76
Warning
Deletion erases ALL files present on the USB memory device.
Note:
The message “ERASE IN PROGRESS... REMAINING TIME” is displayed during the deletion time.
The deletion time of a full USB memory device is less than one minute.
Other USB memory device functions are not available during deletion.
Once deletion of the USB memory device has been started, it cannot be paused, stopped or cancelled.
In case of USB memory device disconnection or deletion error, the message “TRANSFER ERROR - USB
DISCONNECTION” or “ERASE ERROR - TECHNICAL PROBLEM” is displayed. In this case restart the transfer
process. If the problem persists contact your technical service.
When the ventilator is in standby (the ventilator is on, but ventilation has not started), a message
that prompts the ventilator operator to press VENTILATION ON/OFF to start ventilation is
displayed in the right-hand window of the ventilation and alarm menus (Figure 7-29).
PB560C64
To start ventilation:
Press and release VENTILATION ON/OFF (Figure 7-30, item 1).
• The blue light indicator, at the upper right of the VENTILATION ON/OFF key
(see Figure 7-30, item 2), turns off.
• A “beep“ sounds.
• The ventilation starts.
• The values of the monitored parameters are displayed in the right-hand window.
• A new message appears that directs the user to press the key again to confirm ventilation
stop as shown in the following graphic.
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.
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.
Warning
Even though the Puritan Bennett™ 560 Ventilator meets current safety standards, the internal
Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to
be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the
Puritan Bennett 560 Ventilator and/or the associated Lithium-ion battery are subject to strict
transport conditions under the Dangerous Goods Regulation for air transport (IATA:
International Air Transport Association), International Maritime Dangerous Goods code for sea
and the European Agreement concerning the International Carriage of Dangerous Goods by
Road (ADR) for Europe. Private individuals who transport the device are excluded from these
regulations although for air transport some requirements apply. For air transport; the
Puritan Bennett 560 Ventilator is permitted as checked-in or carry-on baggage. Two spare
batteries per person may be taken on board as carry-on luggage only, with the prior approval of
the airline. This classification and regulatory requirements may vary depending upon the
country and mode of transport. Therefore it is recommended that users verify with the carrier /
airline as to which measures to take before the voyage.
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.
The maximum recommended shelf life of the internal battery is two (2) years. Do not use a
battery that has been stored for two years prior to its first use.
Periodic recharging is important to help maximize useful life of the battery. Do not store the
internal battery for extended periods, without recharging, as this may reduce the maximum
life.
Vt 200 ml (± 5 ml)
PIP 10 mbar (± 2 mbar) 11 hours (–10%)
Rtot 20 bpm
Vt300 ml (± 5 ml)
PIP 20 mbar (± 2 mbar) 9 hours (–10%)
Rtot 15 bpm
Vt500 ml (± 5 ml)
PIP 30 mbar (± 2 mbar) 6.5 hours (–10%)
Rtot 15 bpm
Vt750 ml (± 5 ml)
PIP 45 mbar (± 2 mbar)
4.5 hours (–10%)
Rtot 20 bpm
(Maximum Ventilation Parameters)
a. Average durations shown are with a fully charged battery having less than 50 charge/recharge cycles.
Note:
Buzzer 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 BATTERY“ indicator at the top left of the ventilator’s front panel is
continuously lit (Figure 8-1).
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). Refer to Figure 8-3.
The “LOW BATTERY“ and “EMPTY BATTERY“ alarms (refer to chapter 5, “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 on
the internal battery when no other power source is available. 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.
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.
When the battery charge is complete, the “INTERNAL BATTERY“ indicator turns off.
Warning
Even if the “INTERNAL BATTERY“ indicator is off, charge of the battery may sometimes be
incomplete regardless of charge time when the ambient temperature is above 40 °C (104 °F).
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 six (6) hours if the ventilator is on standby and about 13 hours if ventilation is operating.
Warning
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.
8.5 Storage
If the ventilator is to be stored for an extended period of time, it is not necessary to remove the
battery. However, the ventilator should be stored in cool, dry, well-ventilated environment, as
follows:
• Temperature: approximately 21 °C (70 °F)
• Humidity: less than 80% RH
Note:
When the device is in storage it should be recharged monthly to maximise battery life.
If the battery is stored for more than one month at a temperature greater than 21 °C (70 °F), or for
more than one or two weeks at a temperature greater than 45 °C (113 °F), 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 storage for longer than 30 days connect it to an AC power source, turn
on the unit by the I/O switch at the rear of the ventilator, and let it charge for 15 minutes prior to
starting ventilation.
Note:
Fully charge the internal battery prior to disconnecting from AC Power source (“mains”).
The battery should not be stored for more than two years, whatever the conditions.
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 highly recommended. Refer
to chapter 9, “Cleaning”.
To reduce the risk of infection, wash your hands thoroughly before and after handling the
ventilator or its accessories.
Description
Mild dishwashing detergent
70% isopropyl alcohol (rubbing alcohol)
10% chlorine bleach (90% tap water)
Glutaraldehyde
Hospital disinfectant cleaners
Hydrogen peroxide
15% ammonia (85% tap water)
Ammonia-based household cleaners
Household cleaners
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 Exhalation Flow Sensor,” on
page 10-1.
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 open, repair or otherwise service the ventilator yourself. Doing so might
endanger the patient, damage the ventilator, and/or void your warranty. Only personnel
authorised and qualified by Covidien should repair, open or service the ventilator.
Note:
Calibration may be done with either an adult or pediatric circuit; however, Pediatric YES/NO must be
appropriately selected in the ventilator Preferences Menu.
3. Obstruct the patient wye’s open connector using the fleshy portion of your palm to make a
good seal as shown in Figure 10-1.
4. Press the MENU key to access the alarm settings menu – if this is not the menu currently
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.
• 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.
• A short beep sounds to confirm that the FIO2 sensor has been calibrated.
9. Press the ENTER key to exit the FIO2 setup line.
Note:
The FIO2 sensor calibration procedure, once initiated, must run to its conclusion.
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.
1 2
Note:
For a list of parts and accessories, refer to Appendix H, “Parts and Accessories” or contact your service
representative or consult www.puritanbennett.com.
* The exhalation block replacement frequency may be 3 months (**) for patients ventilated by
tracheotomy > 12 hours / day. The replacement frequency may be extended to 6 months for patients
ventilated < 12hours / day depending on the frequency of technician visits.
** This minimum replacement period is based on bench test validation performed under 24/24
continuous ventilation and active humidification conditions over a period of 3 months. (Test report
N°08DE265). Test report results show that no condensation or drops of water that would affect flow
measurement were found in the exhalation block or the Piezzo valve.
Note:
For all additional accessories not necessarily considered as consumables consult the manufacturer’s
recommendations.
To prevent any risk of cross contamination we recommend the use of DAR™ filters (Ref: 351/5856 or
equivalent) to protect the patient outlet port and the exhalation block port.
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.
The exhalation block is intended for single use by a single patient . It may periodically be
cleaned, but it cannot be disinfected or sterilised. To maintain good measurement quality when
used continuously, clean the exhalation block periodically (refer to section 9.3, “Cleaning the
Exhalation Block,” on page 9-2). The exhalation block should be changed every 4 months and
cannot be reused with any other patient.
Note:
As the total number of battery charge/discharge cycles approaches 300, a drop in potential of as much as
20% may be detected.
In the event of a problem with the ventilator, refer to chapter 5, “Alarms and Troubleshooting”.
If you cannot determine the cause of the problem, contact your equipment supplier or Covidien.
For more information and local Covidien Technical Service Contact details, refer to the “Technical
Support” section in Preface chapter.
Equipment and phone numbers to have available in Clinician; Section 10.5, ”Service
cases of emergency. Assistance”
The meaning of symbols and markings. Section 1.3, ”Symbols and Markings”
The parts and purpose of the breathing circuit. Chapter 6, ”Installation and Assembly”
How to recognise and respond to problems with the Chapter 5, ”Alarms and
breathing circuit. Troubleshooting”
The parts and purpose of the nasal interface or mask. Clinician or manufacturer’s instructions
for use.
How to recognise and respond to problems with the Clinician or manufacturer’s instructions
nasal interface or mask. for use.
Replacement interval for outlet filters (per the filter Section 10.4, ”Recommended Schedule
manufacturer’s instructions). of Maintenance”
How to connect the oxygen source to the ventilator Clinician; section 6.8, ”Oxygen”
How to connect the FIO2 sensor to the ventilator Clinician; section 6.8, ”Oxygen”
B.1 Physical
Table B-1. Physical Description (Excluding Accessories)
Ventilator Weight 9.9 lb. (4.5 kg)
Ventilator Dimensions 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)
Connectors Inspiratory limb connector: ISO 22 mm (OD) conical
Exhalation limb connector (on exhalation block): ISO 22 mm (ID)
conical
Oxygen inlet: Female Connector with valve
Device airway volume 2000 ml
Breathing circuit volume
• Adult, dual limb 1150 ml
• Pediatric, dual limb 670 ml
• Adult, single limb 550 ml
• Pediatric, single limb 300 ml
Air Inlet Filter Dimensions: 70 mm long x 60 mm wide
Composition: Polypropylene fiber electrostatic filter material, which is
laminated onto polyurethane open-celled foam.
Efficiency: 99.999982% at 30 Lpm (filtering microbes 3.3 μm)
Inspiratory Bacteria Maximum allowable flow resistance: 4 mbar at 60 lpm
Filter Requirement
B.2 Electrical
Table B-2. AC Electrical Supply
Voltage Frequency Consumption
100 VAC to 240 VAC 50 Hz / 60 Hz 180 VA max
12 VDC NA 8.3 A
30 VDC NA 3.3 A
Specifications
B.4 Performance
B.4.1 Specifications
Table B-8. Performance Parameter Specifications and Tolerances
B.7 Environmental
The following environmental conditions shall be observed:
Table B-11. Environmental Conditions for Storage or Transport
Temperature Humidity Atmospheric Altitude
pressure
-40 °C to +70 °C 10% to 95% RH 500 hPa to 1060 hPa -152 m to 3964 m
(-40 °F to +158 °F) (7.2 psi to 15.4 psi) (500 ft to 13,000 ft)
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 45 °C (113 °F) 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.
B.8 USB
Table B-13. USB Memory Device Specifications
B.9 Pneumatic
Table B-15. Airway Resistances
Inspiratory Exhalation
1.0 mbar at 30 lpm flow ± 0.1 mbar 0.5 mbar at 30 lpm ± 0.1 mbar
3.7 mbar at 60 lpm flow ± 0.1 mbar 1.1 mbar at 60 lpm ± 0.1 mbar
< 5% UT < 5% UT
(> 95% dip in UT for 5 s) (> 95% dip in UT for 5 s)
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
IEC/ EN 61000-4-8 location in a typical
commercial or hospital
environment.
Note:
UT is the AC mains voltage prior to application of the test level.
Recommended separation
distance
Conducted RF 3 Vrms 3 Vrms
IEC / EN 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz
outside ISM bandsa outside ISM bands d =0.35√P
10 Vrms 10 Vrms
inside ISM bandsa inside ISM bands d=1.2√P
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
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.
b
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.
c
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™ 560 Ventilator 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 560 Ventilator.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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.
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 and
EN 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 and EN 60601-1-
4:2004.
• Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral
standard: Usability IEC 60601-1-6:2006 and EN 60601-1-6:2007.
• General Requirements, tests and guidance for alarm systems in medical electrical equipment
and medical electrical systems IEC 60601-1-8:2003 and EN 60601-1-8:2007.
Particular Standards
• Lung Ventilators for Medical Use- Particular Requirements for Basic Safety and Essential
Performance Part 2: Home Care Ventilators for Ventilator-Dependent Patient EN ISO10651-
2:2009.
• Lung ventilators for medical use – Particular requirements for basic safety and essential
performance – Part 2: Home care ventilators for ventilator – dependent patients YY 0600.2-
2007 (ISO 10651-2:2004, MOD).
• Medical electrical equipment – Part 2: Particular requirements for the safety of lung
ventilators – Critical care ventilators GB 9706.28-2006 (IEC / EN 60601-2-12:2001, MOD).
• Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
EN ISO 5306-1:2004.
C.1 Architecture
The Puritan Bennett™ 560 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 servo-controlled
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 exhalation solenoid valve (three-way valve) is fully closed during the inspiratory phase and is
proportionally controlled during the exhalation phase to obtain the bias flow. The speed of the
turbine adapts to the exhalation pressure threshold during the entire exhalation 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.
The flow measurement is automatically corrected as a function of the atmospheric pressure
measured inside the ventilator with the Altitude Compensation feature1. 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 authorised by
Covidien (refer to the Puritan Bennett 560 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.
1. The Altitude Compensation feature is enabled (set to “YES” on the Setup Screen) by default and should
remain at this setting.
Theory of Operation
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.
Note:
The default ventilation mode setting is P A/C; for more information, see below.
Flow Flow
Volume
Volume
Time Time
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 “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.
Airway Airway
Pressure Pressure
Flow Flow
Time Time
P 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.
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 synchronised 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.
Airway
Pressure
Flow
Time
Flow Flow
25%
50%
Time
D.2.5 CPAP
In Continuous Positive Airway Pressure (CPAP) 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 (E Sens = 25%). Refer to the waveforms shown below.
Flow
The operational verification and safety checks listed in Table E-1 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 10.5, “Service Assistance,” on page 10-8).
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.
2 Verify all of the labels and markings on the ventilator are clear and legible. Pass
3 Confirm the air inlet filter is clean and correctly installed. Pass
4 Ensure the AC power cable does not exhibit any signs of damage, such as kinks, Pass
breaks, or damaged insulation.
6 Push the power switch I/O to the I position to activate the ventilator test: Pass
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.
7 Perform the Functioning Alarms Test (refer to Appendix F, “Alarms Tests”). Pass
8 Verify the alarm volume is adapted to the patient environment. Refer to section Pass
7.3, “Preferences Menu Parameters,” on page 7-10 for instructions on changing
the alarm volume setting.
9 Verify that the preventive maintenance schedule for the ventilator is followed. Pass
Refer to chapter 10, “Routine Maintenance”.
10 Ensure the patient breathing circuit is correctly attached to the ventilator, with all Pass
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 monitoring.
This page intentionally blank.
Before connecting the ventilator to the patient, perform the following tests to ensure the
ventilator‘s alarms are working properly.
Warning
Do not perform ventilator alarm tests while the patient is connected to the ventilator. 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 5, “Alarms and Troubleshooting”) of this manual or
call your equipment supplier or Covidien (refer to section 10.5, “Service Assistance,” on
page 10-8).
The setting of the Min PIP alarm must be adjusted for the patient, but must also be set high
enough to allow the PATIENT DISCONNECTION alarm to trigger properly. Perform the Low
Pressure Test (refer to section F.1, “Low Pressure Test,” on page F-1) to ensure the Min 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.
1. Before proceeding, set the ventilation and alarm 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 colour) lights up
• the “PATIENT DISCONNECTION” alarm is displayed
• the audible alarm sounds
5. Press the ALARM CONTROL key once to silence the alarm.
6. Press and hold the VENTILATION ON/OFF key for three (3) seconds, then release it. Press
the VENTILATION ON/OFF key again to confirm stop. The ventilator will switch to Standby mode
and cancel the alarms.
Alarms Tests
1. Disconnect the ventilator from its AC power supply. Ensure that the following events occur:
• the Medium priority indicator (yellow colour) 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 BATTERY indicator illuminates
2. Press the ALARM CONTROL key twice to reset the alarm.
3. Reconnect the ventilator to its AC power supply.
The Puritan Bennett™ 560 Ventilator is delivered with the following items:
(1) Printed User's Manual (language as requested by the customer)
(1) Clinician's Manual on CD (a print copy is available upon request by the customer)
(1) Patient circuit and valve
(1) Set of six (6) combination foam/fine particle air inlet filters
(1) Carrying bag
(1) Oxygen connector
(1) AC power cable
Warning
Users must always possess an additional circuit and valve while using the Puritan Bennett 560
Ventilator.
To minimise the risk of damage, you must use the Dual Bag to transport the Puritan Bennett 560
Ventilator. Refer to Figure G-2.
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 9, “Cleaning”).
5. Ensure that the air inlet filter is installed.
Unpacking and Preparation
Table H-1 provides a list of accessories that are available for the Puritan Bennett™ 560 Ventilator.
To order parts or accessories, contact your equipment supplier or Covidien representative.
Note:
The ventilator is delivered 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 carrying bag; one O2 connector; and one AC power cable.
Description
Carrying bag (grey)
Oxygen inlet connector
Ventilator Cart
Dual Bag (blue or pink)
delivered with:
Backpack Padded Straps, 2 ea.
Suspension belt
Carrying belt
Warning
To minimise the risk of damage, you must use the ventilator’s Dual Bag to
transport the ventilator. See Figure G-2 on page G-2.
Note:
This is the “foam plus fine particle” filter listed in Table 10-1, Consumables and
Replacement Intervals, on page 10-7.
Internal battery
External battery
FIO2 measurement kit
FIO2 sensor
2-way and 3-way DAR™ valves
Parts and Accessories
Description
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 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 1.1 metres (3.6 ft) to 2.0 metres (6.6 feet). 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.
For more information regarding parts and accessories for the Puritan Bennett™ 560 Ventilator
contact your service representative or www.puritanbennett.com.
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.
AI – Apnea Index
The Apnea index is average number of apnea events per hour of ventilation. It is based on the
Apnea Alarm.
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 symbol; often referred to as
“Alarm Silence.”
Back Up Rate
Rate of control cycles in PSV or SIMV modes during apnea phase.
Glossary
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).
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.
cmH2O
An abbreviation for “centimetres of water,” which is a unit of measure for pressure.
Controlled breath
A volume or pressure breath triggered, controlled and terminated by the ventilator.
DC Power
Direct current.
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.
Exhalation Sensitivity
The exhalation sensitivity (E Sens) level is a percentage of peak flow at which a pressure-supported
breath will be terminated.
FIO2 Sensor
The sensor which measures the amount of oxygen being delivered to the patient.
Flow
Volume of gas delivered by the ventilator compared to time, expressed in litres per minute (lpm).
Freeze
Interruption of the waveform plot tracing on the ventilator’s display.
hPa
An abbreviation for “hectopascal“ which is a unit of measure for atmospheric pressure.
I:E ratio
Inspiratory time versus exhalation time ratio.
Inspiratory Phase
Phase of the breath cycle during which the patient inspires.
I/T Ratio
Inspiratory time versus total breath time ratio.
L
litres (a unit of volume).
Leak
When ventilating with a double limb circuit in leak configuration, it is the average parasitic leak
during each cycle and over the past 24 hour period. When ventilating with a single limb circuit
there is no average leak.
LED
Light Emitting Diode; used as indicator lights on the ventilator’s front panel.
lpm
Litres 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.
Max Leak
The maximum alarm setting of a high leakage threshold. An alarm will be triggered in the event the
calculated leakage is exceeded.
Mbar
An abbreviation for “millibar“ which is a unit of measure for atmospheric pressure.
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.
Pause
Waveforms freezing function.
PSI
Pounds Per Square Inch.
Rebreathing
The patient breathes his/her exhaled gas.
Respiration rate
The number of breath cycles (inspiration + expiration) completed within one minute. Normal
resting adult respiratory rates are from 12 – 20 breaths per minute (bpm).
Rise Time
This determines how the target pressure will be reached, and indirectly defines the minimum
inspiration time.
Rtot
Parameter measured by the ventilator equal to the total number of breaths per minute (bpm).
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™ 560 Ventilator is flow-triggered, with sensitivity levels in the range from 1 to
5: the lower the number, the more sensitive the trigger.
Sigh
A sigh is an increased volume of gas delivered to the patient at a set rate. i.e. every 50 breaths.
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.
Unfreeze
Resumption of the waveform plot tracing on the ventilator’s display.
Volume breath
Inspiration of the selected volume, delivered over the selected inspiratory time.
against use of ventilator . . . . . . . . . . . . . . . . .2-2 Erase Data, USB Memory Device . . . . . . . . . . . 7-27
Contrast (display), setting . . . . . . . . . . . . . . . . .7-12 EXH VALVE LEAKAGE alarm message . . . 5-9, 5-17
CONTROLLED CYCLES alarm message . . 5-9, 5-16 Exhalation block . . . . . . . . . . . . . . . . . . . . . . . 6-13
Cooling fan. . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
COOLING FAN alarm message . . . . . . . . 5-9, 5-16 replacement interval . . . . . . . . . . . . . . . . . . 10-7
CPAP mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7 Exhalation flow sensor
CPAP Mode Menu calibrating. . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Alarm parameters . . . . . . . . . . . . . . . . . . . . . .3-7 Expired Tidal Volume (VTE) . . . . . . . . . . . . . . . . 3-6
D F
DC power FAA requirements . . . . . . . . . . . . . . . . . . . . . . . 2-1
cable Faults, technical. . . . . . . . . . . . . . . . . . . . . . . . . 5-1
connecting to ventilator . . . . . . . . . . . . . . .6-5 Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
disconnecting from ventilator . . . . . . . . . . .6-5 air inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
connecting to . . . . . . . . . . . . . . . . . . . . . . . . .6-4 antibacterial . . . . . . . . . . . . . . . . . . . . . . . . 6-11
DC POWER DISCONNECTION alarm message . . 5-9, FIO2 . . . . . . . . . . 3-6, 3-9, 3-13, 3-17, 3-22, 3-28
5-16, 6-5 oxygen and ventilator settings. . . . . . . . . . . 3-29
Device classification . . . . . . . . . . . . . . . . . . . . . .2-3 FIO2 sensor
DEVICE FAULT10 alarm message. . . . . . . 5-9, 5-17 calibrating. . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
DEVICE FAULT11 alarm message. . . . . . . 5-9, 5-17 calibration. . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
DEVICE FAULT12 alarm message. . . . . . . 5-9, 5-17 FIO2 SENSOR MISSING alarm message . . . 5-9, 5-18
DEVICE FAULT13 alarm message. . . . . . . 5-9, 5-17 Fraction of Inspired Oxygen . 3-6, 3-9, 3-13, 3-17,
DEVICE FAULT3 alarm message. . . . . . . . 5-9, 5-16 3-22, 3-28
DEVICE FAULT5 alarm message. . . . . . . . 5-9, 5-16 Freeze function
DEVICE FAULT7 alarm message. . . . . . . . 5-9, 5-16 Freezing a waveform trace . . . . . . . . . . . . . . 4-7
DEVICE FAULT9 alarm message. . . . . . . . 5-9, 5-17 Front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Digital monitoring. . . . . . . . . . . . . . . . . . . . . . . .4-1
Display G
of alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2 Gas delivery system (diagram) . . . . . . . . . . . . . . C-2
setting the backlight . . . . . . . . . . . . . . . . . . .7-11
setting the contrast . . . . . . . . . . . . . . . . . . .7-12
showing waveforms . . . . . . . . . . . . . . . . . . .7-15
H
waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 Heat safety device, battery. . . . . . . . . . . . . 1-4, 6-2
Display Waveforms parameter. . . . . . . . . . . . . .7-15 HIGH FIO2 alarm message . . . . . . . . . . . 5-10, 5-18
Display, bargraph . . . . . . . . . . . . . . . . . . . . . . . .4-6 HIGH INT TEMP COOL VENT alarm message . . 5-10,
Displayed parameters 5-18
monitored . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4 HIGH LEAKAGE alarm message . . . . . . . 5-10, 5-19
Dual bag (accessory) . . . . . . . . . . . . . . . . . . . . .6-18 HIGH PRESSURE alarm message. . . . . . . 5-10, 5-20
Dual Bag (figure). . . . . . . . . . . . . . . . . . . 6-18, G-2 High pressure test . . . . . . . . . . . . . . . . . . . . . . . F-3
HIGH RATE alarm message . . . . . . . . . . 5-10, 5-20
HIGH VTE alarm message . . . . . . . . . . . 5-10, 5-19
E HIGH VTI alarm message . . . . . . . . . . . . 5-10, 5-20
E Sens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 HIGH/LOW BATTERY TEMP alarm message5-9, 5-19
exhalation sensitivity . . . . . . . . . . . . . . . . . . .3-26 Holes, air circulation . . . . . . . . . . . . . . . . . 1-3, 6-1
E Sens exhalation sensitivity . . . . . . . . . . . . . . .3-21 Hot surfaces
E SENS FAULT . . . . . . . . . . . . . . . . . . . . . . . . . .5-17 ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31
E SENS FAULT OR CIRC LEAK alarm message . . .5-9 Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Electrical specifications . . . . . . . . . . . . . . . . . . . .B-1
Electromagnetic compatibility
and mobile/portable communications equipment
I
6-2 I Sens . . . . . . . . . . . . . 3-3, 3-8, 3-12, 3-16, 3-20
Electromagnetic emissions I Sens Inspiratory Sensitivity . . . . . . . . . . . . . . . 3-25
and use of accessories . . . . . . . . . . . . . . . . . .6-2 I Time . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21, 3-26
EMPTY BATTERY alarm message . . . 5-9, 5-17, 8-4 I:E (I/T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Environment I/O switch (figure) . . . . . . . . . . . . . . . . . . . . . . . 7-2
suitable for use of ventilator . . . . . . . . . . . . . .2-1 I/T (I:E) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Environmental specifications . . . . . . . . . . . . . . . .B-8 Ignition sources (warning) . . . . . . . . . . . . . . . . . 6-1
L O
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14 OCCLUSION CHECK CIRCUIT alarm message. . 5-11,
Linked ventilation parameters 5-23
setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21 OCCULSION CHECK CIRCUIT alarm message. . 5-23
Liquids Operational verification checklist . . . . . . . . . . . . E-1
avoid ingress into ventilator (Warning) . . . . . .1-3 Operator/Users
Locking key targeted for use of ventilator. . . . . . . . . . . . . 2-2
disabling. . . . . . . . . . . . . . . . . . . . . . . . . . . .7-29 O-ring, oxygen coupler (Caution). . . . . . . 1-9, 6-15
enabling . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-28 Oxygen
Locking Key and SETUP menu . . . . . . . . . . . . . . .7-3 connecting the supply . . . . . . . . . . . . . . . . . 6-14
Locking the keyboard . . . . . . . . . . . . . . . . . . . .7-28 connector stud . . . . . . . . . . . . . . . . . . 1-9, 6-15
Logs menu disconnecting the supply from the ventilator 6-16
alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3 enrichment . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
LOW BATTERY alarm message1-4, 5-11, 5-21, 8-4 rear panel connector (figure) . . . . . . . . . . . . 6-15
LOW FIO2 alarm message . . . . . . . . . . . 5-11, 5-21 special coupler . . . . . . . . . . . . . 1-9, 6-14, 6-15
Low pressure test . . . . . . . . . . . . . . . . . . . . . . . . F-1 supply connection . . . . . . . . . . . . . . . . . . . . 6-14
LOW VTE alarm message . . . . . . . . . . . 5-11, 5-22 using medical-grade only (Warning) . . 1-9, 6-14
LOW VTl alarm message . . . . . . . . . . . . 5-11, 5-22
replacement interval . . . . . . . . . . . . . . . . . . .10-7 REMOVE VALVE CPAP MODE alarm message . 5-12,
single limb, connecting . . . . . . . . . . . . . 6-7, 6-9 5-23
Patient counter . . . . . . . . . . . . . . . . . . . . . . . . . .7-2 REMOVE VALVE OR CHANGE PRES alarm message .
PATIENT DISCONNECTION alarm message . . . 5-12, 5-12, 5-23
5-23 Repairing the ventilator
Patient hours qualified personnel only (Warning) . .10-1, 10-6,
changing the setting of . . . . . . . . . . . . . . . . .7-8 10-7
Patient/Caregiver Checklist . . . . . . . . . . . . . . . . A-1 Replacement intervals
Patients air inlet filter . . . . . . . . . . . . . . . . . . . . . . . . 10-7
targeted for use of ventilator . . . . . . . . . . . . .2-1 air outlet (antibacterial) filter . . . . . . . . . . . . 10-7
Peak inspiratory flow. . . . . . . . . . . . . . . . 3-4, 3-21 consumables . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Peak inspiratory pressure. . . . . . . . . . . . . . . . . .3-11 exhalation block . . . . . . . . . . . . . . . . . . . . . 10-7
PEEP . . . . . . . . . 3-3, 3-8, 3-11, 3-15, 3-19, 3-25 patient circuit . . . . . . . . . . . . . . . . . . . . . . . 10-7
Performance specifications . . . . . . . . . . . . . . . . .B-3 Replacing
Physical specifications . . . . . . . . . . . . . . . . . . . . .B-1 air inlet filter . . . . . . . . . . . . . . . . . . . . . . . . 10-6
PIP . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-16, 3-27 Resetting alarms . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Placing the ventilator (installing) . . . . . . . . . . . . .6-1 RESTART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Pneumatic specifications . . . . . . . . . . . . . . . . . . .B-9 Rise Time. . . . . . . . . . . . . . . 3-3, 3-11, 3-21, 3-26
Positive end expiratory pressure . . . . . . . . . . . .3-11 Risk of fire (warning) . . . . . . . . . . . . . . . . . . . . . 6-1
Power failure test . . . . . . . . . . . . . . . . . . . . . . . . F-2 Rtot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
POWER FAULT alarm message . . . . . . . 5-12, 5-23
Power On Self Test (POST). . . . . . . . . . . . . . . . . .7-2 S
POWER SUPPLY LOSS alarm message . . 5-12, 5-23 Safety
Precautions for use onboard alarm system . . . . . . . . . . . . . . . . . . 2-2
electromagnetic interference . . . . . . . . . . . .1-10 Service assistance information . . . . . . . . . . . . . 10-8
Precautions for use, cautions Setting ventilation parameters . . . . . . . . . . . . . 7-20
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10 Setup Configuration
installation SETUP menu . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
environment. . . . . . . . . . . . . . . . . . . . . . .1-10 SETUP screen
maintenance . . . . . . . . . . . . . . . . . . . . . . . .1-10 changing parameters . . . . . . . . . . . . . . . . . . 7-4
Precautions for use, warnings screen shot . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 Sigh Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
installation Sigh VT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
electrical power supplies. . . . . . . . . . . . . . .1-3 SOFTWARE VERSION ERROR alarm message . . 5-12,
maintenance . . . . . . . . . . . . . . . . . . . . . . . .1-10 5-24
oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10 Specifications
settings . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10 electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Preference menu environmental. . . . . . . . . . . . . . . . . . . . . . . . B-8
changing the settings in . . . . . . . . . . . . . . . .7-11 indicators and alarms . . . . . . . . . . . . . . . . . . B-3
displaying . . . . . . . . . . . . . . . . . . . . . 7-10, 7-24 manufacturer’s declaration . . . . . . . . . . . . . B-10
PRES SENS FLT1 alarm message. . . . . . . 5-12, 5-23 performance . . . . . . . . . . . . . . . . . . . . . . . . . B-3
Pressure bar chart . . . . . . . . . . . . . . . . . . . . . . . .4-1 physical. . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Principles of operation . . . . . . . . . . . . . . . . . . . C-1 pneumatic. . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-24 range, resolution, and accuracy . . . . . . . . . . . B-4
PROX SENS FLT2 alarm message . . . . . . 5-12, 5-23 standards compliance and IEC classification. B-14
PSV mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1 ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
PSV Mode Menu Standards, compliance, and IEC classification
Alarm parameters . . . . . . . . . . . . . . . . . . . . . .3-2 specifications . . . . . . . . . . . . . . . . . . . . . . B-14
Starting ventilation . . . . . . . . . . . . . . . . . . . . . 7-29
R Stopping ventilation . . . . . . . . . . . . . . . . . . . . 7-30
Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-26 Storing the internal battery . . . . . . . . . . . . . . . . 8-5
Range, resolution, and accuracy specifications . .B-4 Stud, oxygen connector. . . . . . . . . . . . . . 1-9, 6-15
Rate . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-20, 3-25
Rate (Respiratory Rate) . . . . . . . . . . . . . . . . . . .3-11 T
Reactivating alarms . . . . . . . . . . . . . . . . . . . . . . .5-6 Target Tidal Volume . . . . . . . . . . . . . . . . . . . . . 3-5
Recharging the internal battery . . . . . . . . . . . . . .8-4 Target tidal volume . . . . . . . . . . . . . . . . . 3-5, 3-12
V W
V A/C mode . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14 Warnings
V A/C Mode Menu definition of . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
alarm parameters . . . . . . . . . . . . . . . . . . . . .3-14 general list of . . . . . . . . . . . . . . . . . . . . . . . . 1-1
V SIMV mode . . . . . . . . . . . . . . . . . . . . . . . . . .3-23 ventilator-dependent patients . . . . . . . . . . . . 3-7
V SIMV Mode Menu Warranty . . . . . . . . . . . . . . . . . . . . . . . . . Preface-xi
Alarm parameters . . . . . . . . . . . . . . . . . . . . .3-24 Waveform menu
Ventilation parameters . . . . . . . . . . . . . . . . .3-23 monitored parameters (figure). . . . . . . . . . . . 4-2
VALVE MISSING CONNECT VALVE alarm message Waveform tracing . . . . . . . . . . . . . . . . . . . . . . . 4-7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-24 Freezing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
VENT STDBY indicator. . . . . . . . . . . . . . . . . . . . .7-2 unfreezing . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Ventilation Waveforms
menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7 display . . . . . . . . . . . . . . . . . . . . . . . . 4-6, 7-15
starting. . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-29 menu . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9, 4-6
stopping . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-30 Welcome Menu screen
Ventilation modes. . . . . . . . . . . . . . . . . . . 2-2, D-1 display of . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
and apnea . . . . . . . . . . . . . . . . . . . . . . . . . . D-6 skipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
changing during ventilation . . . . . . . . . . . . .7-17 Wheelchair
changing while on standby . . . . . . . . . . . . . .7-17 mounting the ventilator onto . . . . . . . . . . . 6-18
setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16
VENTILATION ON/OFF key . . . . . . . . . . . . . . . . . .7-2
Ventilation parameters
digital monitoring . . . . . . . . . . . . . . . . . . . . . .4-1
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Covidien llc,
15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited,
IDA Business & Technology Park,Tullamore.