Covidien Puritan Bennett 560 Ventilator Clinician's Manual
The Puritan Bennett 560 Ventilator is a portable ventilator that provides non-invasive and invasive ventilation for patients with respiratory insufficiency. It offers a variety of modes and breaths to accommodate different patient needs, including pressure support ventilation (PSV), continuous positive airway pressure (CPAP), assist/control (A/C), and synchronized intermittent mandatory ventilation (SIMV).
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Clinician's Manual
Puritan Bennett
TM
560 Ventilator
Copyright information
COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. All other brands are trademarks of a Covidien company.
© 2012, 2015 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 product manuals web page at: http://www.covidien.com/rms/sales-support/product-manuals
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.
To obtain information about a warranty, if any, contact Covidien Technical Services at 1.800.635.5267 or your local representative.
Purchase of this instrument confers no express or implied license under any Covidien patent to use the instrument with any ventilator that is not manufactured or licensed by Covidien.
Table of Contents
Preface
3
2
Safety Information 1
Warnings Regarding Electrical Power Supplies
Warnings Regarding Hoses and Accessories
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Ventilator Overview
Operating Parameters
Clinician’s Manual i
ii
5
4
For Various Oxygen and Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Monitored Parameters
Alarms and Troubleshooting
6 Installation and Assembly
2
sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-23
Clinician’s Manual
Table of Contents
7 Operating Procedures
8
Internal Battery
Clinician’s Manual iii
iv
10
9
Cleaning
Routine Maintenance
C
A
B
Calibrating the Exhalation Flow Sensor
Patient/Caregiver Checklist
Specifications
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Theory of Operation
Clinician’s Manual
Table of Contents
D Modes and Breath Types
I
G
H
E
F
Operational Verification Checklist
Alarms Tests
Unpacking and Preparation
Parts and Accessories
Glossary
Clinician’s Manual v
Page Left Intentionally Blank vi
List of Figures
Figure 4-1. Ventilation Menu: Pressure Leakage Configuration Modes
Clinician’s Manual vii
viii
Figure 6-18. Connecting the FiO
2
sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Clinician’s Manual
List of Figures
Figure 10-5. Calibrating the FiO
sensor (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Figure 10-6. Calibrating the FiO
Sensor (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Figure 10-7. Calibrating the FiO
Sensor (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Figure 10-8. Calibrating the FiO
Sensor (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Clinician’s Manual ix
Page Left Intentionally Blank x
List of Tables
Clinician’s Manual xi
xii Clinician’s Manual
Preface
Purpose of This Manual
This manual contains important information regarding the safe operation of your Puritan Bennett™ 560 Ventilator. Your ventilator is an electrical device that can provide years of useful service with the proper care, as described in this manual.
Ensure that you read and understand the instructions contained in this manual before operating the ventilator.
WARNING:
Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter
, “
Qualification of Personnel
Installation and maintenance of the device must be made by authorized and trained personnel.
In particular, training for the handling of products sensitive to electrostatic discharges must include the use of Electrostatic Discharge (ESD) protection devices and knowledge of the following symbol’s meaning: , as well as using original spare parts and respecting quality assurance and traceability rules approved by Covidien.
Warranty
Information regarding your product warranty is available from your sales representative or Covidien.
xiii
Preface
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.
For online technical support, visit the SolvIT
SM
Center Knowledge Base by clicking the link at http://covidien.com/rms/sales-support/. Here, you will find answers to frequently asked questions about the product and other
Covidien products 24 hours a day, 7 days a week. If you require further assistance, contact your local Covidien representative.
Technical Support
Covidien Argentina
Vedia 3616
Buenos Aires
Argentina
Tel: (5411) 4863-5300
Fax: (5411) 4863-4142
Covidien Belgie S.A.-N.V.
Generaal De Wittelaan 9/5
Mechelen
2800
België
Tel +32 220 08260
Fax +32 270 06690
Covidien Chile
Lo Boza 107
Pudahuel
Santiago de Chile, Chile
Tel: (562) 231-3411
Fax: (562) 231-3527
Technical Service Contacts:
Covidien Australia
52A Huntingwood Drive
Huntingwood, NSW 2148
Australia
Telephone (+61) 1800 350702
Fax +612 9671 8118
Covidien Austria GmbH
Campus21
Europaring F09402
Brunn am Gebrige
A-2345 Österreich
+43 1 20609 1143
+43 1 20609 2457
Covidien Brazil
Praça Agrícola La Paz Tristante, 121
Osasco – São Paulo / CEP 06276-035
São Paulo, SP
Brasil 04795-100
Tel: (5511) 5683-8300
Fax: (5511) 5683-8349
Covidien Canada
19600 Clark Graham
Baie d'Urfe, QC, H9X 3R8
Canada
Tel: 1-877-664-8926, option 2
Fax: 1-514-695-7534
Covidien Colombia
Edificio Prados de la Morea
Carretera Central Del Norte
(Cra 7a)Kilometro 18,
Chia-Cundinamarca
Bogota, Colombia
Tel: (571) 619-5469
Fax: (571) 619-5425
Covidien Costa Rica
Global Park, Parkway 50
La Aurora, Heredia, 40104
Costa Rica
Tel: (506) 256-1170
Fax: (506) 256-1185
Fax: (506) 290-8173 xiv Clinician's Manual
Clinician's Manual
Technical Support
Covidien ECE s.r.o. organizační složka
Prosek, Prosecká 852/66
190 00 Praha 9
Tel.: +420 241 095 735
Fax: +420 239 016 856
Covidien ECE
Galvaniho 7/a
821 04 Bratislava
Slovenska Republika
Tel +42 124 821 45 73
Fax +42 124 821 45 01
Technical Service Contacts:
Covidien Danmark A/S
Langebrogade 6E, 4. sal
1411 København K
Danmark
Tel +45 43 68 21 71
Fax:+45 43 31 48 99
Covidien Finland Oy
Rahtitie 3
FI-01530 Vantaa
Finland
Te. +358 9 725 192 88
Fax +358 9 725 192 89
Covidien Hellas SA
8 Fragoklisias Street
Maroussi, 151 25
Greece
Tel +30 211 180 36 00
Fax +30 210 614 63 80
Covidien Israel
5 Shacham St.
North Industrial Park
Caesarea
38900 Israel
Tel +97 246 277 388
Fax +97 266 277 688
Covidien Hungary
1095 Budapest
Mariassy u. 7
Magyarorszag
Hungary
Tel + 36 1880 7975
Fax + 36 1777 4932
Covidien Italia S.p.A.
Via S.Bovio 3
San Felice , 20090 Segrate (MI) Italy
Tel +39 02 91483320 (option 3)
Fax +39 02 91294863
Covidien Mexico
Av. Insurgentes Sur 863, Pisos 15 y 16
Col. Nápoles
Del. Benito Juárez
México, D.F. 03810 México
Tel: (5255) 5804-1524
Fax: (5255) 5685-1899
Covidien Nederland BV
Hogeweg 105
5301 LL Zaltbommel
Nederland
Tel +31 202061470
Fax +31 707 709229
Covidien Panama
Parque Industrial Costa del Esta
Calle Primera, Edifio # 109
Panama City, Panama
Tel: (507) 264-7337
Fax: (507) 236-7408
Covidien Polska
Al. Jerozolimskie 162
Warszawa. 02-342
Polska
Tel +48 22 30 60034
Fax +48 22 30 60853
Covidien Deutschland GmbH
Technisches Service Center
Raffineriestr. 18
93333 Neustadt / Donau
Germany
Tel + 49 69 51 709670
Fax + 49 69 29 9571608
Covidien France SA
Parc d’affaires Technopolis
Bat. Sigma, 3 Avenue du Canada
LP 851 Les Ulis
91975 Courtaboeuf Cedex France
Tel +33 1 57 32 35 10
Fax +33 1 57 32 70 10
Covidien Ireland Commercial Ltd
Block G, Ground Floor,
Cherrywood Technology Park,
Loughlinstown
County Dublin
Ireland
Tel +353 1 4381613
Covidien Japan Inc.
Technical Support Center
83-1, Takashimadaira 1-Chome
Itabashi-ku, Tokyo 175-0082 Japan
Tel: +81 (0) 3 6859 0120
Fax: +81 (0) 3 6859 0142
Covidien Norge AS
Postboks 343
1372 Asker.
Norway
Tel +47 2415 9887
Fax +47 2302 4955
Covidien Portugal Lda.
Estrada do Outeiro de Polima, Lote
10-1° Abóboda
2785-521 S.Domingos de Rana
Portugal
Tel +35 21 761 62 44
Fax +35 800 781385
xv
Preface
Covidien Puerto Rico
Palmas Industrial Park
Road 869 Km 2.0 Bdlg. #1
Cataño, PR 00962
Tel. 787-993-7250
Ext. 7222 & 7221
Fax 787-993-7234
Covidien South Africa
Corporate Park North
379 Roan Crescent
Randjespark
Midrand, South Africa
Tel +27 115 429 500
Fax +27 115 429 547
Covidien Switzerland
Roosstr. 53
Wollerau
8832
Schweiz
Tel +41 44 511 82 71
Fax +41 44 511 16 34
Technical Service Contacts:
Covidien Russia
53 bld. 5 Dubininskaya Street
Moscow
RUSSIA. 119054 Poccии
Tel +70 495 933 64 69
Fax +70 495 933 64 68
Covidien Saglik A.S.
Maslak Mahallesi Bilim Sokak No: 5,
Sun Plaza Kat: 2-3
Sisli, Istanbul 34398
Turkey
Tel +90 212 366 20 00
Fax +90 212 276 35 25
Covidien Spain S.L.
Servicio Técnico
WTC Almeda Park
Plaça de la Pau, S/N - Edif. 7, 3ª Planta
08940 Cornellá de Llobregat
Barcelona, Spain
Tel +34 91 275 48 54 (Opción 3)
Fax +34 91 276 89 33
Covidien Sverige AB
Box 54
171 74 Solna
Sweden
Tel +46 8 517 615 73
Fax + 46 8 502 521 10
Covidien UK & Ireland
Unit 2, Talisman Business Park
London Road, Bicester
OX26 6HR, United Kingdom
Tel +44 20 3027 1757
Fax +44 20 3684 8869
Covidien Singapore
Singapore Regional Service Centre
15 Pioneer Hub, #06-04
Singapore 627753
Tel (65) 6578 5187 / 8 / 9
Fax (65) 6515 5260.
Email: [email protected]
xvi Clinician's Manual
1 Safety Information
1.1
Definitions
This manual uses three indicators to highlight critical information: Warning, Caution, and Note.
They are defined as follows:
WARNING
Indicates a condition that can endanger the patient or the ventilator operator.
Caution
Indicates a condition that can damage the equipment.
Note
Indicates points of particular emphasis, that make operation of the ventilator more efficient or convenient.
It is essential to read, understand and follow these instructions before using the Puritan Bennett™ 560 Ventilator.
In order to use the ventilator correctly and efficiently and to help prevent incidents, please pay particular attention to section
,” as well as all warnings and cautions contained throughout this manual.
1.2
Warnings
1.2.1
General Warnings Regarding Use
WARNING:
The ventilator must be used only under the responsibility and on the prescription of a doctor.
WARNING:
The ventilator must be used according to its intended use. Refer to section
1-1
1-2
Safety Information
WARNING:
Be aware this manual describes how to respond to ventilator, but it does NOT tell you how to respond to the patient.
WARNING:
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.
WARNING:
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.
WARNING:
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.
WARNING:
The ventilator must not be used with flammable anesthetic substances.
WARNING:
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.
WARNING:
A ventilator-dependent patient should always be monitored by trained and competent medical personnel. Ensure that the patient’s caregiver is able and prepared to take suitable action in the event the ventilator identifies an alarmed condition or experiences a problem.
WARNING:
Do not use a patient circuit with a leak accessory for ventilator-dependent patients.
WARNING:
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.
Clinician's Manual
Warnings
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.
WARNING:
Verify the functionality of the alarm conditions before connecting the patient to the ventilator.
Refer to Appendix
.”
WARNING:
If the ventilator fails the alarm tests or if you cannot complete the tests, refer to Chapter
,
” or call your equipment supplier or Covidien.
WARNING:
When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
WARNING:
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.
WARNING:
To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
WARNING:
A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a double-limb circuit is used – is recommended. Refer to Chapter
WARNING:
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.
1.2.2
Warnings Regarding Installation and Environment of Use
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
Clinician's Manual 1-3
1-4
Safety Information
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.
WARNING:
To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the ventilator.
,
List of Consumables and Accessories
WARNING:
Regularly clean the ventilator’s Dual Bag according to manufacturer’s recommendations.
WARNING:
The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately.
WARNING:
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.
WARNING:
To ensure correct and lasting operation of the device, ensure that the ventilator is installed and operated in the environmental conditions recommended in Appendix
WARNING:
Do not leave power cables lying on the ground where they may pose a hazard.
WARNING:
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.
WARNING:
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.
Clinician's Manual
Warnings
WARNING:
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.
WARNING:
Place the ventilator in a safe place when ventilating and according to the recommendations in this manual.
WARNING:
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.
WARNING:
To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes (main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains.
WARNING:
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 stabilize in its operating environment for at least two (2) hours prior to use.
WARNING:
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.
WARNING:
The default setting for altitude compensation is YES. Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations.
WARNING:
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.
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
,
”). This is particularly important when the ventilator is installed on a
wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
Clinician's Manual 1-5
1-6
Safety Information
WARNING:
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.
1.2.3
Warnings Regarding Electrical Power Supplies
WARNING:
Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off.
WARNING:
The operator should connect the ventilator to an AC power source whenever available, for safer operation.
WARNING:
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.
WARNING:
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.
WARNING:
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
, “
Connecting to External AC Power
WARNING:
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
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 its internal battery to recharge.
Clinician's Manual
Warnings
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.
WARNING:
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
Connecting to an External DC Power
.”
WARNING:
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.
WARNING:
When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.
WARNING:
Batteries should be disposed of according to environmental legislation in your country and locality.
WARNING:
Never expose any batteries to direct flame.
WARNING:
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.
1.2.4
Warnings Regarding Hoses and Accessories
WARNING:
The ventilator must not use, nor be connected to, any anti-static or electrically conductive hoses, tubing, or conduits.
WARNING:
Minimum and maximum VTE alarm parameters must be properly set to warn in the event of patient disconnection.
Clinician's Manual 1-7
1-8
Safety Information
WARNING:
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.
WARNING:
The patient circuit should not be changed during ventilation.
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.
WARNING:
Single Use accessories should not be reused.
WARNING:
The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when
used continuously, clean the exhalation block periodically (refer to section
”). The exhalation block should be changed every 4 months and cannot be reused with any other patient.
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 minimize drying of the patient’s airway and subsequent irritation and discomfort, must be used.
WARNING:
If exhaled tidal volume measurements are required to ensure correct patient ventilation a doublelimb 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.
WARNING:
Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause serious damage to the ventilator.
WARNING:
Before cleaning the ventilator, first disconnect the ventilator and the patient circuit.
Clinician's Manual
Warnings
WARNING:
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.
WARNING:
The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.
WARNING:
The patient circuit should always be positioned to avoid hindering the patient's movements, to prevent accidental disconnection or leakage, and to minimize the risk of patient strangulation.
WARNING:
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
, for a list of recommended patient circuits.
WARNING:
Resistance of the exhalation valve and accessories (water traps, filters, HMEs, etc.) must be as low as possible.
WARNING:
Adding attachments to the ventilator breathing system can cause the pressure during exhalation at the patient connection port to increase.
WARNING:
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.
WARNING:
Users must always possess an additional breathing circuit and exhalation valve while using the
Puritan Bennett™ 560 Ventilator.
WARNING:
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.
WARNING:
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.
Clinician's Manual 1-9
Safety Information
WARNING:
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.
WARNING:
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.
WARNING:
To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in
” and Appendix
.” The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 1.1 meters (3.6 feet) to 2.0 meters (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.
WARNING:
To ensure proper performance of the ventilator, use only accessories (including oxygen accessories) approved and recommended by Covidien. See Appendix
, “
contact your customer services.
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.
WARNING:
Before using the Nurse Call system, ensure that its connections are secure and it operates properly.
For more information, contact Covidien.
WARNING:
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.
1-10 Clinician's Manual
Warnings
WARNING:
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.
1.2.5
Warnings Regarding Settings
WARNING:
Before starting ventilation, always verify that all settings are properly set in accordance with the required prescription.
WARNING:
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.
WARNING:
The CPAP mode does not provide a set respiratory rate. Do not use this mode for ventilatordependent patients.
WARNING:
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.
WARNING:
Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. The audible alarm vents located at the front of the device should never be obstructed. The alarm can be paused with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared.
WARNING:
Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths.
WARNING:
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.
Clinician's Manual 1-11
Safety Information
WARNING:
In adult or pediatric use ensure that the adjusted tidal volume is compatible with the needs of the patient.
WARNING:
When changing the mode during ventilation, significant transitions of pressure, flow or cycling rate might occur, depending on the difference between the modes. Before setting the new mode, first ensure that the settings between the different modes are compatible. This reduces the risk of discomfort and harm to the patient.
WARNING:
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.
WARNING:
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
”) to ensure the Low PIP alarm is properly set.
WARNING:
If APNEA TIME is set to a value higher than 60/Control R then the APNEA alarm will not activate.
WARNING:
If an APNEA alarm is required, set the APNEA setting to YES in the Preferences Menu.
WARNING:
The Apnea Alarm should be set to YES for ventilator dependent patients.
WARNING:
Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
WARNING:
Ensure the Insp Time setting is compatible with the physiological requirements of the patient.
WARNING:
Adjustable alarms should not be systematically canceled; instead, they should be adjusted according to the needs and condition of the patient.
1-12 Clinician's Manual
Warnings
WARNING:
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:
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.
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 0P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.
WARNING:
The sound level of the alarms should be adjusted according to the installation environment and the size of the area monitored by the patient’s caregiver. Ensure that the alarm sound apertures at the front of the device are never obstructed.
1.2.6
Warnings Regarding USB Memory Device
WARNING:
Always verify the file ID before using a USB memory device to transfer data between the ventilator and a PC.
1.2.7
Warnings Regarding Maintenance
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.
WARNING:
To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator, only personnel authorized and qualified by Covidien should attempt to service or make authorized modifications to the Puritan Bennett™ 560 Ventilator.
Clinician's Manual 1-13
Safety Information
WARNING:
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.
WARNING:
To ensure proper performance of the ventilator, the preventative maintenance schedule should be followed. For further information contact Covidien.
WARNING:
On a daily basis, ensure the proper connection and operation of the patient circuit.
WARNING:
If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER.
If necessary, remove the patient from the ventilator and provide an alternative means of ventilation.
WARNING:
After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.
WARNING:
Use all cleaning solutions and products with caution. Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator. Use only those solutions listed in
WARNING:
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.
WARNING:
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 authorized and qualified by Covidien should repair, open or service the ventilator.
WARNING:
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.
1-14 Clinician's Manual
Warnings
WARNING:
The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically (refer to section
”). The exhalation block should be changed every 4 months and cannot be reused with any other patient.
WARNING:
Ensure that the exhalation block is completely dried after cleaning and prior to use.
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
Calibrating the Exhalation Flow Sensor
.”
WARNING:
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
.”
WARNING:
A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a double-limb circuit is used – is recommended. Refer to Chapter
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
,
”). 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:
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.
WARNING:
If the device is damaged, its external housing is not correctly closed, or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odour, alarms not triggered
Clinician's Manual 1-15
Safety Information
during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
WARNING:
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.
WARNING:
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.
WARNING:
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.
WARNING:
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.
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.
WARNING:
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.
1.2.8
Warnings Regarding Oxygen
WARNING:
The ventilator must not be used with flammable anesthetic substances.
WARNING:
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.
1-16 Clinician's Manual
Warnings
WARNING:
Strictly follow the instructions provided in section
,” which include the use of a flow regulator and special oxygen connector.
WARNING:
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.
WARNING:
The Puritan Bennett™ 560 Ventilator can be used with an optional oxygen analyzer with minimum and maximum concentration alarms. Always measure the delivered oxygen with a calibrated oxygen analyzer (FiO
2
kit) that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
WARNING:
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.
WARNING:
Ensure that the oxygen supply pressure to the machine never exceeds 7 psi (50 kPa) or a flow of
on page
for volume and sensitivity tolerances.
WARNING:
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.
WARNING:
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.
WARNING:
Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical-grade oxygen.
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.
Clinician's Manual 1-17
Safety Information
WARNING:
To prevent any interference with the internal sensors of the ventilator, do not install a humidifier upstream of the ventilator.
WARNING:
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).
WARNING:
The oxygen supply hose ages even when it is not in use and should be replaced periodically.
Follow the expiration date, if any.
WARNING:
The oxygen supply must be regulated using a flow meter connected to the source gas outlet.
WARNING:
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.
WARNING:
Before connecting the oxygen supply, ensure that the stud on the oxygen connector is protruding outwards.
WARNING:
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.
1.2.9
Warnings Regarding Electromagnetic Interference
WARNING:
The Puritan Bennett™ 560 requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix
“
.” In particular, the use of nearby mobile and portable communications equipment using radio frequencies, such as mobile telephones or other systems exceeding the levels set in
the IEC 60601-1-2 standard, may affect its operation. Refer to section
,”
.”
WARNING:
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
1-18 Clinician's Manual
Symbols and Markings
equipment protection against electromagnetic emissions. If the ventilator is used adjacent to such accessories or stacked with such devices, the ventilator’s performance should be monitored to verify normal operation.
1.3
Symbols and Markings
Symbols
Table 1-1. Ventilator 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
, 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
, item 5.
Direct current, DC (IEC 60417-5031).
This symbol appears on the ventilator’s back panel and keyboard; see
Alternating current, AC (IEC 60417-5032).
This symbol appears on the ventilator’s back panel and keyboard; see
Internal Battery.
This symbol appears on the ventilator’s keyboard; see
, item 10.
Insulation class II equipment (IEC 60417-5172).
A regulatory standard classification for protection against electric shock. Class II equipment relies on double insulation rather than protective earthing.
This symbol appears on the ventilator’s back panel; see
, item 5.
Index of Protection rating for the ventilator’s enclosure, defined in IEC 60529 (BSEN60529:1991).
The first digit, 3, indicates protection against the intrusion of small foreign bodies (including fingers, tools, wires, etc. with a diameter greater than 2.5 mm) into the ventilator. The second digit, 1, indicates protection against water dripping or falling vertically, as well as an environment featuring water vapor condensation and/or light rain.
This rating appears on the ventilator’s back panel; see
, item 5.
CSA – Canadian Standards Association.
This symbol appears on the ventilator’s back panel; see
, item 5.
CE – Conformity European
Signifies compliance with the medical device directive 2007/47/EC.
This symbol appears on the ventilator’s back panel; see
, item 5.
This symbol appears on the ventilator’s front panel UP/UNFREEZE key; see
on page
, 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.
Clinician's Manual 1-19
Safety Information
Symbols
Table 1-1. Ventilator Symbols (Continued)
Descriptions
This symbol appears on the ventilator’s front panel DOWN/FREEZE key; see
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
This key is used to confirm command actions.
This symbol appears on the ventilator’s front panel ALARM CONTROL key; see
This key is used to: cancel the audible portion of alarms for 60 seconds at a time; cancel an alarm.
For more information, see Appendix
.”
This symbol appears on the ventilator’s front panel MENU key; see
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
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
, 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
, item 4.
Patient proximal pressure port.
This symbol appears on the front right of the ventilator, adjacent to the From Patient port; see
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
Oxygen inlet.
This marking appears on the back panel of the ventilator, adjacent to the oxygen inlet port; see
, item 2.
Nurse Call connector.
This symbol appears on the back panel of the ventilator, adjacent to the nurse call connector; see
, item 2.
Switch in “Off” position (IEC 60417-5008).
This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator to indicate the switch’s “Off” position. See
Switch in “On” position (IEC 60417-5007).
This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator to indicate the switch’s “On” position. See
, item 2.
1-20 Clinician's Manual
Clinician's Manual
Symbols and Markings
Symbols
Table 1-1. Ventilator Symbols (Continued)
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
, “
.”
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
on page
, item 1 and Chapter
information.
Pressure rise times (inspiratory phase) parameter.
These symbols appear on the ventilation mode menu screens. For more information, see Chapter
.” In pressure ventilation modes, you can select one of four rise times with setting 1 represent-
ing 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 infor-
, “
.” 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
,
Selecting the Preferences Menu
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
.”
Inspiratory Effort Detected.
This symbol appears in the front panel display’s Status window when the patient triggers a breath.
Parameter adjustment bar.
This graphic shows the current setting for parameters such as display contrast and alarm volume in the Preferences menu. See section
, “
.”
WEEE (Waste Electrical and Electronic Equipment).
This symbol means that this product must not be disposed of with household waste. Observe local ordinanc-
, item 5.
Year of Manufacture.
Manufacturer.
1-21
Safety Information
Symbols
Table 1-1. Ventilator Symbols (Continued)
Descriptions
Audio Paused (alarm key once).
This symbol means the sounding of audible alarms is currently disabled. This period lasts for 60 seconds. For more information, see section
Pausing the Audible Portion of Alarms
Alarm Paused (alarm key twice).
This symbol means one or more alarms have been paused, or reset/canceled. The alarm is paused until the
alarm condition is corrected and the condition reoccurs. For more information, see section
.”
Alarm Off (Apnea Off).
This symbol means that the Apnea Alarm has been set to OFF in the Preference menu. For more information, see section
Exhalation Valve detected.
This symbol means that an exhalation valve has been detected during ventilation.
No Exhalation Valve detected.
This symbol means that no exhalation valve has been detected during ventilation.
Single patient use only (ISO 7000-1051).
This symbol means that the labeled device is for use by a single patient only.
Freeze Waveforms.
This symbol means the tracing of patient pressure and flow waveforms is currently paused or “frozen.”
For more information, see section
.”
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
, item 11.
PC connector.
This symbol indicates a port that can be used by authorized Covidien product service personnel or Covidien
service personnel for software maintenance. See
, item 10.
Atmospheric pressure limitation.
Humidity limitations.
Temperature limitations.
1-22 Clinician's Manual
Labels / Identification and Instruction Information
Table 1-1. Ventilator Symbols (Continued)
Descriptions Symbols
Fragile.
Keep dry.
Keep away from direct sunlight.
This side up.
1.4
Labels / Identification and Instruction Information
Various labels or specific markings are affixed to the ventilator that describe precautions to be taken for the correct use of the ventilator and contribute to the traceability of the product. See
and the figures on the following pages for illustrations of these labels and markings and
their locations on the ventilator. Use the item numbers in
Table 1-2.
Ventilator Labels and Markings
,
)
2. Oxygen Inlet Marking and Label
(
)
3. Exhalation Valve and Patient Pressure Con-
)
4. From Patient Port, Exhalation Limb
Connection of Patient Circuit – Single
Use Exhalation Block Label (
,
5. Air Inlet Label
(
)
6. Exhaled Gas Outlet Label
(
)
Clinician's Manual 1-23
Safety Information
Table 1-2.
Ventilator Labels and Markings (Continued)
7. Identification Label
)
1 Location of AC power cable connector
8. AC Power (Mains) Cable Connector Marking
(
1 Location of DC power cable connector
9. External Cable Connector Marking
11. USB Port marking (
12. Nurse Call Cable Connector Marking
13. FiO
2
Label (
)
Note:
The item number callouts in the following figures refer to those listed in
1-24 Clinician's Manual
Clinician's Manual
Labels / Identification and Instruction Information
Figure 1-1. Locations of Labels—Top-Front View
Figure 1-2. Locations of Labels—Front-Left View
1-25
Safety Information
Figure 1-3. Location of Labels and Markings—Rear View
Figure 1-4. Location of Labels—Bottom View
1-26 Clinician's Manual
2 Ventilator Overview
2.1
Indications for Use
•
•
The Puritan Bennett™ 560 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 lb (5 kg) who require mechanical ventilation.
The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a doctor. It is essential to read, understand, and follow these instructions before using the Puritan Bennett 560 Ventilator.
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. See Chapter
, “
Standards Compliance and IEC Classification
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
2-1
2-2
Ventilator Overview
•
•
•
•
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.
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
.”
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.
2.3
Operational Use
•
•
•
•
•
The Puritan Bennett 560 Portable Ventilator uses a micro-turbine to provide ventilatory support to patients. Clinicians may use a variety of interfaces to connect patients to the ventilator for continuous or intermittent ventilatory support. Some examples include mouthpieces; nasal masks or full face masks; endotracheal tubes and tracheotomy tubes. User-selectable ventilation modes are:
Assisted Controlled Volume (V A/C)
Assisted Controlled Pressure (P A/C)
Volume Synchronized Intermittent Mandatory Ventilation (V SIMV)
Pressure Synchronized Intermittent Mandatory Ventilation (P SIMV)
Continuous Positive Airway Pressure (CPAP)
Clinician's Manual
Device Classification
•
Pressure Support Ventilation with apnea ventilation (PSV/ST)
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, see Chapter
”
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
, “
” on page
).
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 (see Chapter
”).
Breathing Circuit
The ventilator can be used with a single or double-limb patient circuit. If exhaled volume monitoring is required (such as ventilator dependent patients), use the double-limb circuit for exhaled
tidal volume monitoring. For more information, see section
, “
.
WARNING:
Users must always possess an additional breathing circuit and exhalation valve while using the
Puritan Bennett™ 560 Ventilator.
2.4
Device Classification
•
•
The ventilator’s IEC / EN 60601-1classification is as follows: protection/insulation class (electric shock): class II protection index of enclosure: IP31
•
•
•
• medical device directive classification: II B degree of protection against risk of electric shock: BF power: external (AC – mains, or DC – cigarette lighter) or internal (DC – battery) operation mode: continuous operation
For additional information, see Appendix
.”
Clinician's Manual 2-3
Ventilator Overview
2.5
Front Panel
Figure 2-1. Front Panel
2-4
1
2
3
LCD Display—Displays information about the ventilator including patient hours and software version, ventilation modes and settings, and monitored and calculated patient data and waveforms. The display also allows the user to view and, using the Control Panel, adjust the ventilator’s operating and alarm configuration settings.
6
Control Panel—Features the controls for setting up and operating the ventilator, and LEDs to indicate the ventilator's power source, ventilation On/Off status, and alarm priority level. Control functions include turning on and off the ventilation, configuring ventilation modes, pausing audible alarms, canceling alarms, and setting device and alarm parameters.
7
FiO
2
Sensor Connection—Connection for FiO
2
sensor which monitors the amount of oxygen in the patient circuit.
8
Exhalation Valve Port—Nipple for providing piloting pressure to the exhalation valve. Controls the open-closed position of the exhalation valve.
Lateral and Front Openings—Vents that allow for air circulation to cool the ventilator’s internal components. In addition, these openings function as sound ports for audible alarms.
WARNING:
Do not cover or obstruct these openings.
From Patient Port—Exhaled volume measurements are taken from this port, through which a portion of the exhaled gas is diverted to the exhalation flow sensor. VTE is calculated from this flow measurement.
1
Exhaled Gas Outlet—Exhalation Valve connects here.
4
5
Patient Connection Port—Provides an outlet for the gas to be delivered to the patient via the patient circuit.
Patient Pressure Monitoring Port—Nipple for monitoring proximal patient pressure.
9
1.
If exhaled tidal volume monitoring is required, use the double-limb circuit.
Clinician's Manual
2.6
Back Panel
Figure 2-2. Back Panel
Back Panel
Clinician's Manual
1
2
3
Ergonomic carrying handle.
On/Off (I/O) switch with protective cover:
Device powered on in position I; device switched off in position 0.
AC power (“Mains”) cable connector.
7
8
9
PC Cable Connector:
USB mini-B connector used for Puritan Bennett™
Ventilator Test Software.
O
2
Inlet Port:
Connects the ventilator to a low pressure oxygen source via an adapter connected to the O
2
Inlet
” on page
Nurse Call Output Connector:
Used to connect the ventilator to the nurse call system.
4
AC power (“Mains”) cable holding system:
Secures AC power cable to avoid accidental disconnection.
10
USB Memory Device connection:
USB connection to be used with Puritan Bennett respiratory insight software. There are two USB type A ports.
5
Access cover for the internal battery.
6
DC power cable connector with key.
11
Air Inlet Filter:
Filters air as it enters the ventilator.
2-5
Ventilator Overview
2.7
Control Panel
Figure 2-3. Control Panel
2-6
1
Alarm indicators (two LEDs):
Red indicator:
• Continuous: Very High Priority (VHP) alarm activated
• High priority (HP) alarm activated.
Yellow indicator:
• Medium priority (MP) alarm activated.
6
DOWN/FREEZE key:
• Moves the cursor down and decreases parameter values.
• During ventilation, freezes displayed waveform in the Waveform menu.
2
ALARM CONTROL key:
• Press once to pause an audible alarm for
60 seconds.
• Press twice to halt visual and audible alarms. If alarm is remedied, the alarm is canceled (other than the high pressure alarm).
7
MENU key:
Changes the displayed menu. From the Ventilation menu screen, press this key to display the Alarm menu screen.
When a USB memory device is inserted into the ventilator, press this key to display the USB memory device screen.
3
Display screen:
Display of modes, ventilation settings, patient data and waveforms, configuration of the ventilator and alarm management.
4
UP/UNFREEZE Key:
• Moves the cursor up and increases parameter values.
• During ventilation reactivates waveform tracing in the Waveform menu.
5
ENTER key:
• Access to a setting value and validation of the modification of this setting.
• Access to a sub-menu.
8
9
Ventilation status indicator:
• Blue indicator illuminated: device is powered on and ventilation is off (on standby).
• Blue indicator off: ventilation is on.
10
VENTILATION ON/OFF button:
• ON: Press briefly and release to start ventilation.
• OFF: Press and hold for three (3) seconds, then press again to stop ventilation.
Electrical power source indicators:
• AC POWER indicator lit: AC power source connected.
• DC POWER indicator lit: DC power source connected.
• INTERNAL BATTERY indicator lit continuously: Internal battery in use (no external power source connected.)
• INTERNAL BATTERY indicator flashing: battery charging.
Clinician's Manual
2.8
Ventilation Menu
Figure 2-4. Ventilation Menu Display
Ventilation Menu
Ventilation menu with ventilation on standby.
Ventilation menu during ventilation.
1
General information line:
Displays the current ventilation mode, along with the following:
• Battery symbol if the device is powered by the internal battery.
2
Ventilation settings:
Displays the specific ventilation parameter values for the currently selected ventilation mode. See
, “
more information.
• Audio paused symbol if an alarm is currently inhibited.
• Alarm paused symbol if an alarm has been canceled manually and the cause of the alarm remains.
• Apnea Alarm deactivation .
3
Preferences menu access line:
Highlight this line and press the ENTER menu.
key to display the Preferences
” on page
for more information.
• Exhalation valve symbol.
• No exhalation valve
symbol.
• Absolute ABS symbol.
• Relative REL symbol.
4
Bargraph:
Displays pressure generation during ventilation.
5
Status/monitored data window:
• Ventilation stopped (Standby): displays the message, “PRESS TO
START VENTILATION.”
• Ventilation on: parameters are monitored and displayed.
• The Inspiratory Effort Detected symbol appears adjacent to the monitored I:E ratio when the patient actively triggers a breath.
6
Alarm conditions window:
For Active alarms, scrolls through active alarm messages in flashing reverse video.
For Inactive alarms, displays the last alarm along with its trigger date and
end-of-event time. See Chapter
,
” for details.
Clinician's Manual 2-7
Ventilator Overview
2.9
Alarm Menu
Figure 2-5. Alarm Menu
2-8
Alarm menu with ventilation on standby.
Alarm menu when not in standby.
1
Title line:
Displays ventilation mode and the following symbols:
2
• Battery if the ventilator is powered by the internal battery.
• Audio paused if an alarm is currently inhibited.
• Alarm paused if an alarm has been canceled manually and the cause of the alarm remains.
• Apnea Alarm deactivation .
• Exhalation valve symbol.
Alarm settings:
Displays the specific alarm parameter values for the currently selected ventilation mode, which are:
• Min and Max alarm threshold settings, and
• Current monitored patient readings, or hyphen (-) when ventilation is in standby.
3
Access line to Alarm Logs menu.
Highlight this line and press the ENTER
key to display the Alarm Logs menu.
, “
4
• No exhalation valve symbol.
Status/monitored data window:
• Ventilation stopped (Standby): displays the message, “PRESS TO
START VENTILATION.”
• Ventilation on: parameters are monitored and displayed.
• The Inspiratory Effort Detected symbol appears adjacent to the monitored I:E ratio when the patient actively triggers a breath.
5
Alarm message window:
• For Active alarms, scrolls through active alarm messages in flashing reverse video.
• For Inactive alarms, displays the last alarm along with its trigger date and
end-of-event time. See Chapter
“
” for more information.
Clinician's Manual
Waveforms Menu
2.10
Waveforms Menu
) is optional and can be selected using the Menu
key
”). The Waveform menu is only accessible when ventilation
is active.
Figure 2-6. Waveforms Menu
1
Title line:
• Displays ventilation mode and the following symbols:
• Battery if the ventilator is powered by the internal battery.
2
Graphic zone:
Displays the patient’s pressure and flow waveforms as a function of time.
For more information, see
3
Numeric zone:
Displays monitored data.
• Audio paused rently inhibited.
if an alarm is cur-
• Alarm paused if an alarm has been canceled manually and the cause of the alarm remains.
• Apnea Alarm deactivation .
• Freeze Waveforms if the tracing of patient waveforms has been halted during ventilation
.• Exhalation valve symbol.
• No exhalation valve symbol.
Clinician's Manual 2-9
Ventilator Overview
2.11
USB Memory Device Menu
Figure 2-7. USB Memory Device Menu
1
Title line
2
Ventilator serial number
3
USB Memory Device Menu
4
Dialogue box
2.12
If Ventilator Failure Occurs
If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER.
If necessary, remove the patient from the ventilator and provide an alternate means of ventilation.
Keep in mind that troubleshooting information is available in this manual to assist you in the
event of a problem. See Chapter
.”
If you cannot determine the cause of a problem, contact your equipment supplier or Covidien.
See section
.”
2-10 Clinician's Manual
3 Operating Parameters
This chapter describes ventilation and alarm parameters and their setting ranges for each ven-
tilation mode. For a listing of operating parameters and monitored patient data, see
. For further information about the different ventilation modes and breath types
provided by the Puritan Bennett™ 560 Ventilator, see Appendix
, “
.”
WARNING:
If APNEA TIME is set to a value higher than 60/Rate then the APNEA alarm will not activate.
3.1
PSV Mode Parameters and Setting Ranges
The menus for PSV – Pressure Support Ventilation mode are shown in
:
Figure 3-1. Menus in PSV Mode with exhalation valve configuration
3-1
Operating Parameters
Figure 3-2. Menus in PSV Mode with leakage configuration
3-2
The ventilation parameters and setting ranges available in PSV mode are listed in
Name
P Support
PEEP
Rise Time
I Sens
E Sens
1
Backup R
Apnea Time
Vt Target
Min I Time
Max P
Max I Time
Units
Table 3-1. Ventilation Parameters in PSV Menu
Min. Value Max. Value Adjustment
Resolution
cmH
2
O, mbar or hPa
Standby: 2
Valve configuration: 5
Leak configuration: 6
Standby: 55
Valve configuration: 55
Leak configuration: 30
1 cmH
2
O, m bar or hPa
–
–
%
Standby: OFF
Valve configuration:
1
0P
5 (-95)
OFF
Leak configuration: 4
20
4
5
95 (-5)
1
1
1
5 bpm s ml
4
1
50
40
60
2000
1
1
10
Default
Value
15
OFF s mbar s
0.1
8
0.8
2.8
55
3
1.
See Chapter
, “
” for information on positive and negative E Sens settings.
0.1
1
0.1
2
2
Auto
13
Auto
OFF =
100
Auto
Pi + 3
Auto
Linked
Parameters
PEEP
P Support
Max P
I Time
–
–
Min I Time
Backup R
–
Max I Time
–
Min I Time
Clinician's Manual
PSV Mode Parameters and Setting Ranges
lists the available alarm settings in PSV mode.
Name
Min VTI
Max VTI
Min VTE (with exhalation valve)
Max VTE (with exhalation valve)
Max Leak
(with leak configuration)
Max Rtot
Min FiO
2
Max FiO
2
Table 3-2. Alarm Parameters in PSV Mode
Units Min.
Value
Max.
Value
Adjustment
Resolution
ml 30 2000 10 ml ml
80
30
3000
1990
10
10 ml lpm
80
5
3000
200
10
5
Default
Value
300
2,000
300
1000
OFF
Linked
Parameters
Max VTI
Min VTI
Max VTE
Min VTE
– bpm
%
%
10
18
30
70
90
100
1
1
1
OFF
OFF
OFF
Backup R
Max FiO
2
Min FiO
2
P Support—Pressure Support
When Relative Pressure is set to YES in the Setup Menu, P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase.
In this configuration, the sum of P Support and PEEP must not exceed 55 mbar.
When Relative Pressure is set to OFF in the Setup Menu, P Support allows you to determine inspiratory Absolute pressure.
In this configuration, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
PEEP—Positive End Expiratory Pressure
PEEP allows you to determine the level of pressure maintained during the exhalation phase.
When Relative Pressure is set to YES in the Setup Menu, the sum of P Support and PEEP must not exceed 55 mbar.
When relative pressure is set to OFF, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.
In leak configuration, the minimum PEEP setting is 4 mbar.
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.
Clinician's Manual 3-3
3-4
Operating Parameters
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.
I Sens—Inspiratory Trigger Sensitivity
I Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath.
The sensitivity levels decrease from 0P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.
I Sens 0 (P) = Bias flow + (0.4 lpm to 0.6 lpm) (P = Pediatric use)
I Sens 1 (P) = Bias flow + (0.4 lpm to 0.8 lpm) (P = Pediatric use)
I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)
I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)
I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)
I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO
2
).
The inspiratory trigger is initiated after a time delay of between 300 ms to 2000 ms
,
depending on the preceding peak inspiratory flow.
WARNING:
Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths.
WARNING:
Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering. Level
0P, the most sensitive inspiratory trigger, is recommended for pediatric use. For an adult, this setting may result in ventilator autotriggering.
E Sens—EXHALATION SENSITIVITY
E sens is available in the PSIMV, VSIMV, and PSV modes.
E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.
Clinician's Manual
PSV Mode Parameters and Setting Ranges
The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting.
The exhalation trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.
If the flow drop is insufficient, exhalation is automatically triggered independently of the E Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time has elapsed. For more information about maximum inspiratory time, see Min and Max I Time - Minimum/Maximum Inspiration Time.
Figure 3-3. Exhalation Trigger Sensitivity y2 Exhalation x Seconds y1 Inspiration
Note:
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.
Clinician's Manual 3-5
3-6
Operating Parameters
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. 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.
Note:
The Backup R value applied depends on the Rate setting.
Note:
If the Apnea Alarm is set to OFF in the Preferences Menu, the Apnea Time setting will still be active.
Vt Target—TARGET TIDAL VOLUME
Vt Target allows the ventilator to deliver a target volume of gas to the patient.
When a Vt Target is set, the ventilator constantly adjusts the target inspiratory pressure between
Pi and Max P to ensure the inspired tidal volume remains as close as possible to the Vt target.
Vt Target should be more than 10 ml higher than Min VTE and more than 10 ml lower than Max
VTI to avoid triggering VTI or VTE alarms.
The minimum increase or decrease of target inspiratory pressure is 0.5 mbar and the maximum is
2 mbar.
Setting the Vt Target is not mandatory (it can be set to “OFF”).
Max P—MAXIMUM INSPIRATION PRESSURE
Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the Target Tidal Volume. (Vt Target)
P Support and Max P are related and the difference between them must be less than 20 mbar.
Max P is not displayed when Vt Target is set to OFF.
Min and Max I Time—MINIMUM / MAXIMUM INSPIRATION TIME
Min I Time and Max I Time are ventilation parameters that can be adjusted in the alarm menu.
Min I Time defines the minimum duration of time the inspiratory phase is maintained. It takes priority over activation of the exhalation trigger which can only be triggered after the Min I Time has expired.
Clinician's Manual
PSV Mode Parameters and Setting Ranges
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 cycle triggered by the ventilator.
If Backup R is changed, Min I Time is, if necessary, automatically readjusted so that the difference between them is always maintained.
The minimum time by default if no parameter is set (Min I Time = AUTO) corresponds to the Rise
Time to which an operating margin of 0.3 seconds is added.
on page
Rise Time.
Max I Time defines the maximum duration of time during which the inspiratory phase is maintained. The switch-over to exhalation occurs
,
at the latest
,
after this time has expired.
By default, if no parameter is set, the maximum time (Max I Time = AUTO) is the shortest time between a fixed time of three (3) seconds and half the duration of the patient’s inspiratory breaths expressed in seconds. (AUTO equals the lesser of 3 seconds or 30/Rate). This default value will be applied if it is lower than the Max I Time setting.
Min I Time and Max I Time are related so that the Max I Time cannot be set to a value lower than the Min I Time.
VTI (Min and/or Max Alarm Settings)—INSPIRATORY TIDAL VOLUME
It is possible to set a minimum and/or maximum Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.
This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI” alarm) or greater than the maximum threshold set (“HIGH VTI” alarm). See Chapter
Min VTI and Max VTI are related, and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.
VTE (Min and/or Max Alarm Settings)—EXHALATION TIDAL VOLUME
Use a double-limb patient circuit configuration when setting the minimum and/or maximum
Exhalation Tidal Volume alarm parameters.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE” alarm) or greater than the maximum threshold set
(“HIGH VTE” alarm). See Chapter
Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
VTE is displayed when ventilating with an exhalation valve.
It is not mandatory to set the minimum and maximum VTE alarm limits. When the minimum and maximum VTE alarm limits are not set, the display will read “OFF” for these settings.
Clinician's Manual 3-7
Operating Parameters
Max Leak (Max Alarm Settings)
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.
Max Leak is displayed when ventilating without an exhalation valve.
Setting the Max Leak is not mandatory (it can be set to “OFF”)
,
but the measured value is always displayed.
Max Rtot (Max Alarm Setting)—TOTAL BREATH RATE
The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering.
The alarm setting is used to trigger the “HIGH RATE” alarm. See Chapter
When set, the Max Rtot threshold must always exceed the Backup Rate by 5 bpm. If the Backup
Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of
5 bpm.
Setting the Max Rtot is not mandatory (it can be set to “OFF”)
,
but the measured value is always displayed.
FiO
2
– (Min and/or Max Alarm Settings)—FRACTION OF INSPIRED OXYGEN
An FiO
2
sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.
Min and Max FiO
2
thresholds can be set to trigger “LOW FiO
2
” or “HIGH FiO
2
” alarms.
Min FiO
2
and Max FiO
2
thresholds are related and their settings must maintain a minimum difference of 10% between the two.
Min and Max FiO
2
settings can be set to OFF if an FiO
2
sensor is not connected. Settings are automatically restored once a sensor is reconnected.
These settings are the same for all ventilation modes.
3-8 Clinician's Manual
CPAP Mode Parameters and Setting Ranges
3.2
CPAP Mode Parameters and Setting Ranges
The menus in CPAP (Continuous Positive Airway Pressure) ventilation mode are shown below:
Figure 3-4. Menus in CPAP Mode in leakage configuration
The ventilation parameters and setting ranges available in CPAP mode are listed in
Name
PEEP
Table 3-3. Ventilation Parameters in CPAP Menu
Units Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Linked
Parameters
4 20 1 10 Pi cmH
2
O, mbar or hPa s 1 60 1 Auto Backup R
Apnea Time
1
1.
Not available if Apnea Alarm is set to OFF in Preferences Menu.
lists the available alarm settings in CPAP mode.
Name
Min VTI
Max VTI
Max Leak
Max Rtot
Units
Table 3-4.
Alarm Parameters in CPAP Mode
Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
ml ml lpm bpm
30
80
5
10
2,000
3,000
200
70
10
10
5
1
300
2,000
OFF
OFF
Linked
Parameters
Max VTI
Min VTI
–
Backup R
% 18 90 1 OFF Min FiO
2
Max FiO
2
% 30 100 1 OFF Max FiO
2
Min FiO
2
WARNING:
The CPAP mode does not feature control cycles. Do not use this mode for ventilator-dependent patients.
Clinician's Manual 3-9
Operating Parameters
Note:
Only leak configuration is available in CPAP mode.
PEEP—Positive End Expiratory Pressure
PEEP allows you to determine the level of pressure maintained during the exhalation phase.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”).
A PEEP value can be set to determine the level of pressure maintained during the inspiratory phase and the exhalation phase.
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.
VTI (Min and/or Max Alarm Settings)—INSPIRATORY TIDAL VOLUME
It is possible to set a Min and/or Max Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.
This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI” alarm) or greater than the maximum threshold set (“HIGH VTI”
.”
Min VTI and Max VTI are related, and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.
Max Leak (Max Alarm Settings)
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.
It is not mandatory to set the maximum LEAK alarm limit. When the maximum LEAK alarm limit is not set, the display will read “OFF” for these settings.
Max Rtot (Max Alarm Setting)—TOTAL BREATH RATE
The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering.
The alarm setting is used to trigger the “HIGH RATE” alarm. See Chapter
When set, the Max Rtot threshold must always exceed the Backup Rate by 5 bpm. If the Backup
Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of
5 bpm.
3-10 Clinician's Manual
P A/C Mode Parameters and Setting Ranges
Setting the Max Rtot is not mandatory (it can be set to “OFF”)
,
but the measured value is always displayed.
I Sens—INSPIRATORY TRIGGER SENSITIVITY
The trigger threshold for switching to inhalation cannot be set in CPAP mode. The device is configured with a default I Sens of 2.
E Sens—EXHALATION TRIGGER SENSITIVITY
The trigger threshold for switching to exhalation cannot be set in CPAP mode. The device is configured with a default E Sens of 25%.
FiO
2
(Min and/or Max Alarm Settings)—Fraction of Inspired Oxygen
An FiO
2
sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.
Min and Max FiO
2
thresholds can be set to trigger “LOW FiO
2
” or “HIGH FiO
2
” alarms.
Min FiO
2
and Max FiO
2
thresholds are related and their settings must maintain a minimum difference of 10% between the two.
Min and Max FiO
2 settings can be set to OFF if an FiO
2
sensor is not connected. Settings are automatically restored once a sensor is reconnected.
These settings are the same for all ventilation modes.
3.3
P A/C Mode Parameters and Setting Ranges
The menus in P A/C (Pressure Assisted/Controlled) ventilation mode are shown in
Figure 3-5. Menus in P A/C Mode with exhalation valve configuration
Clinician's Manual 3-11
Operating Parameters
Figure 3-6. Menus in P A/C Mode with leakage configuration
3-12
The Ventilation parameters adjustable in P A/C mode are listed in
Name
Pi
PEEP
Rise Time
Rate
Insp Time
I Sens
Vt Target
Max P
Units
cmH
2
O, mbar or hPa cmH
2
O, mbar or hPa
– bpm s
– ml cmH
2
O, mbar or hPa
Table 3-5. Ventilation Parameters in PA/C Mode Menu
Min. Value Max. Value Adjustment
Resolution
Default
Value
Linked
Parameters
Valve configuration: 5
Leak configuration: 6
Standby: OFF
Valve configuration: OFF
Leak configuration: 4
1
Standby: 2 Standby: 55
Valve configuration: 55
Leak configuration: 30
20
4
1
1
1
15
OFF
2
PEEP
Pi
1
0.3
OFF
50
8
60
6.0
5
2000
55
1
0.1
1
10
1
13
1.5
2
OFF
Pi + 3
Rate
I/T
Max Rtot
Rate
Vt
Apnea Time
–
Min VTE
Max VTE
Min VTI
Max VTI
Pi
PEEP
Clinician's Manual
P A/C Mode Parameters and Setting Ranges
lists the adjustable alarm parameters in P A/C mode.
Name
Min VTI
Max VTI
Min VTE
(with exhalation valve)
Max VTE
(with exhalation valve)
Table 3-6. Alarm Parameters in PA/C Mode
Units Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Linked
Parameters
ml ml ml
30
80
30
2,000
3,000
1,990
10
10
10
300
2000
300
Max VTI
Min VTI
Max VTE ml 80 3,000 10 1000 Min VTE
Max Leak
(leakage configuration)
Max Rtot
Min FiO
2
Max FiO
2 ml bpm
%
%
5
10
18
30
200
70
90
100
5
1
1
1
OFF
OFF
OFF
OFF
–
Rate
Max FiO
2
Min FiO
2
Pi—Inspiratory Pressure
When Relative Pressure is set to YES in the Setup Menu, Pi allows you to determine inspiratory pressure added to PEEP during the inspiratory phase.
In this configuration, the sum of Pi and PEEP must not exceed 55 mbar.
When Relative Pressure is set to OFF in the Setup Menu, Pi allows you to determine inspiratory
Absolute pressure.
In this configuration, Pi and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
PEEP—Positive End Expiratory Pressure
PEEP allows you to determine the level of pressure maintained during the exhalation phase.
When Relative Pressure is set to YES in the Setup Menu, the sum of Pi and PEEP must not exceed
55 mbar.
When relative pressure is set to OFF, Pi and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.
In leak configuration, the minimum PEEP setting is 4 mbar.
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.
Clinician's Manual 3-13
Operating Parameters
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.
Rate—RESPIRATORY RATE
Rate allows you to define the minimal frequency of mandatory ventilator breaths.
If the patient actuates the inspiration trigger, Total Rate may increase.
Insp Time—INSPIRATORY TIME
This parameter allows the user to set the inspiratory time to 0.3-6.0 s. When changing Insp Time, the ventilator displays the corresponding I:E ratio or I/T% in the settings window. The maximum
I:E setting is constrained to 1:1.
I Sens—INSPIRATORY TRIGGER SENSITIVITY
I Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.
The sensitivity levels decrease from 0P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.
I Sens 0 (P) = Bias flow + (0.4 lpm to 0.6 lpm) (P = Pediatric use)
I Sens 1 (P) = Bias flow + (0.4 lpm to 0.8 lpm) (P = Pediatric use)
I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)
I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)
I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)
3-14 Clinician's Manual
P A/C Mode Parameters and Setting Ranges
I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO
2
).
The inspiratory trigger is initiated after a time delay of between 300 ms to 2000 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 0P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.
Vt Target—TARGET TIDAL VOLUME
Vt Target allows the ventilator to deliver a target volume of air to the patient.
When a Vt Target is set, the ventilator constantly adjusts the target inspiratory pressure between
Pi and Max P to ensure the inspired tidal volume remains as close as possible to the Vt target.
Vt Target should be more than 10 ml higher than Min VTE and more than 10 ml lower than
Max VTI to avoid triggering VTI or VTE alarms.
The minimum increase or decrease of target inspiratory pressure is 0.5 mbar and the maximum is
2 mbar.
Setting the Vt Target is not mandatory (it can be set to “OFF”).
Max P—MAXIMUM INSPIRATION PRESSURE
Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the Target Tidal Volume. (Vt Target)
Pi and Max P are related and the difference between them must be less than 20 mbar.
Max P is not displayed when Vt Target is set to OFF.
VTI (Min and/or Max Alarm Settings)—INSPIRATORY TIDAL VOLUME
It is possible to set a Min and/or Max Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.
This setting is used to trigger an alarm if the tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI” alarm)
,
or greater than the maximum threshold set (“HIGH VTI” alarm). See Chapter
Min VTI and Max VTI are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.
VTE (Min and/or Max Alarm Settings)—EXPIRED TIDAL VOLUME
A Min and/or Max Tidal volume expired by the patient can always be set but can only be used in a double-limb circuit configuration.
Clinician's Manual 3-15
Operating Parameters
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE” alarm) or greater than the maximum threshold set
(“HIGH VTE” alarm). See Chapter
, “
.”
Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.
VTE is displayed when ventilating with an exhalation valve.
Setting Min VTE and Max VTE is not mandatory (they can be set to “OFF”)
,
but the display of the measured value is always active in double-limb configuration.
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.
Max Rtot (Max Alarm Setting)—TOTAL BREATH RATE
The maximum rate threshold setting is used to warn of hyperventilation or autotriggering of the ventilator. This setting is used to trigger the “HIGH RATE” alarm. See Chapter
.”
The Max Rtot threshold must always be set at least 5 bpm higher than the Rate. If the Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.
Setting the Max Rtot is not mandatory (it can be set to “OFF”)
,
but the measured value is always displayed.
FiO
2
(Min and/or Max Alarm Settings)—FRACTION OF INSPIRED OXYGEN
An FiO
2
sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.
Min and Max FiO
2
thresholds can be set to trigger “LOW FiO
2
” or “HIGH FiO
2
” alarms.
Min and Max FiO
2
thresholds are related and their settings must maintain a minimum difference of 10% between the two.
Min and Max FiO
2 settings can be set to OFF if an FiO
2
sensor is not connected. Settings are automatically restored once a sensor is reconnected.
These settings are the same for all ventilation modes.
3-16 Clinician's Manual
V A/C Mode Parameters and Setting Ranges
3.4
V A/C Mode Parameters and Setting Ranges
The menus in the V A/C (Volume Assisted/Controlled) ventilation mode are shown in
Figure 3-7. Menus in the V A/C Mode
The ventilation parameters that are adjustable in the V A/C mode are shown in
Name
Table 3-7. Ventilation Parameters in V A/C Ventilation Mode
Units Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Linked
Parameters
Vt ml 50 2000 10 500
PEEP cmH
2 hPa
O, mbar or
OFF 20 1 OFF
Rate
Min VTE
Max VTE
Vt Sigh
Min PIP
Max PIP
Ramp Pattern
Rate
I:E
(I/T)
Insp Time
– bpm
–
(%) s
D
1
1/4
(20%)
0.3
SQ
60
1/1
(50%)
6.0
–
1
1/0.1
(1%)
0.1
D
13
1/2
(33%)
1.5
–
Max Rtot
–
I Sens
Sigh
1
Rate
Sigh Vt
– 0P
50
5
250
1
50
2
50
Rate
Vt
Apnea Time
–
–
– 1.0
2.0
0.1
1 –
1.
When set to YES, Sigh Vt and Sigh Rate are displayed. A Sigh Rate of 50 means a sigh is delivered every
50 breaths. Sigh can be set to YES for Rate values of 4 or more.
Clinician's Manual 3-17
Operating Parameters
The alarm parameters adjustable in V A/C mode are as follows:
Name
Table 3-8.
V A/C Mode Alarm Parameters
Units
Min PIP cmH
2
O, mbar or hPa
Max PIP cmH
2
O, mbar or hPa
Min VTE ml
Min.
Value
2
12
30
Max.
Value
52
60
1,990
Adjustment
Resolution
Default
Value
Linked
Parameters
1 2 PEEP
Max PIP
1
10
40
300
PEEP
Min PIP
Vt
Max VTE
Max Rtot
Min FiO
2
Max FiO
2 ml bpm
%
%
80
10
18
30
3,000
70
90
100
10
1
1
1
1000
OFF
OFF
OFF
Vt
Rate
Max FiO
2
Min FiO
2
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).
PEEP—POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the level of pressure maintained during the exhalation phase.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”).
Ramp Pattern—FLOW SHAPE
This parameter is used to adjust the flow distribution shape (or ramp pattern) during the inspiratory phase.
The three flow patterns available are:
Ramp Pattern: (square waveform) or constant flow
•
•
Ramp Pattern: Decelerated (sawtooth waveform) or decreasing flow.
•
Ramp Pattern: Sinusoidal flow
Rate—RESPIRATORY RATE
Rate allows you to define the frequency of ventilation cycles triggered by the ventilator.
3-18 Clinician's Manual
V A/C Mode Parameters and Setting Ranges
If the patient actuates the inspiratory trigger, Total Rate may increase.
For physiological and efficiency reasons, Rate setting is limited by the settings of Vt and I:E (I/T).
Insp Time—INSPIRATORY TIME
This parameter allows the user to set the inspiratory time to 0.3-6.0 s. When changing Insp Time, the ventilator displays the corresponding I:E ratio or I/T% in the settings window. The maximum
I:E setting is constrained to 1:1.
I Sens—INSPIRATORY TRIGGER SENSITIVITY
I Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.
The sensitivity levels decrease from 0P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.
I Sens 0 (P) = Bias flow + (0.4 lpm to 0.6 lpm) (P = Pediatric use)
I Sens 1 (P) = Bias flow + (0.4 lpm to 0.8 lpm) (P = Pediatric use)
I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)
I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)
I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)
I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO
2
).
The inspiratory trigger is initiated after a time delay of between 300 ms to 2000 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 0P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.
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.
PIP (Min and Max Alarm Settings)—PEAK INSPIRATORY PRESSURE
A minimum and maximum inspiratory pressure alarm threshold must be set.
The Min PIP (or Low Pressure) setting determines the trigger threshold for the “PATIENT DISCON-
NECTION“ alarm. See Chapter
.” If this pressure level is not reached during a fixed time, the alarm is triggered.
Clinician's Manual 3-19
Operating Parameters
WARNING:
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
) to ensure the LOW PIP alarm is properly set.
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. See Chapter
, “
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.
VTE (Min and/or Max Alarm Settings)—EXPIRED TIDAL VOLUME
Minimum and/or maximum expired tidal volume settings are adjustable, but can only be used with a double-limb circuit configuration.
These thresholds can be set to trigger an alarm if the tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE“ alarm) or greater than the maximum threshold set
(“HIGH VTE“ alarm). See Chapter
, “
.”
Min VTE and Max VTE are linked to Vt so that Vt must be greater than Min VTE by at least 10 ml but lower than Max VTE by at least 10 ml.
If Vt is changed, Min VTE and Max VTE are automatically readjusted so that the difference between them is always maintained.
VTE is displayed when ventilating with an exhalation valve.
Setting Min VTE and Max VTE is not mandatory (they can be set to “OFF“, which is the default setting), but the measured value is always displayed when using double-limb configurations.
Max Rtot (Max Alarm Setting)—TOTAL BREATH RATE
The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering.
Its setting is used to trigger the “HIGH RATE“ alarm. See Chapter
, “
When set, the Max Rtot threshold must always exceed the Rate setting by at least 5 bpm. If the
Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of
5 bpm.
Setting the Max Rtot is not mandatory (it can be set to “OFF“, the default setting), but the measured value is always displayed.
3-20 Clinician's Manual
P SIMV Mode Parameters and Setting Ranges
FiO
2
(Min and/or Max Alarm Settings)—FRACTION OF INSPIRED OXYGEN
An FiO
2
sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.
Min and Max FiO
2
thresholds can be set to trigger “LOW FiO
2
” or “HIGH FiO
2
” alarms.
FiO
2
Min and FiO
2
Max thresholds are related and their settings must maintain a minimum difference of 10% between the two.
Min and Max FiO
2
settings can be set to OFF if an FiO
2
sensor is not connected. Settings are automatically restored once a sensor is reconnected.
These settings are the same for all ventilation modes.
3.5
P SIMV Mode Parameters and Setting Ranges
The menus in the P SIMV (Synchronized Intermittent Mandatory Ventilation Pressure) ventilation
Figure 3-8. Menus in P SIMV Ventilation Mode
shows the adjustable Ventilation parameters in P SIMV mode.
Name
Table 3-9. Ventilation Parameters in P SIMV Ventilation Mode
Units Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
Linked
Parameters
5 55 1 15 PEEP Pi
P Support cmH
2
O, mbar or hPa
PEEP cmH
2
O, mbar or hPa cmH
2
O, mbar or hPa
5
OFF
55
20
1
1
15
OFF
PEEP
P Support
Pi
Clinician's Manual 3-21
Operating Parameters
Table 3-9. Ventilation Parameters in P SIMV Ventilation Mode (Continued)
Name
Rate
Units
bpm
Min.
Value
1
Max.
Value
40
Adjustment
Resolution
1
Default
Value
13
Linked
Parameters
Max Rtot
Insp Time
Insp Time s 0.3
2.4
0.1
1.5
Rate
Vt
Apnea Time
– E Sens
I Sens
Rise Time
Apnea Time
%
–
– s
5 (-95)
0P
1
1
95 (-5)
5
4
60
5
1
1
1
25
2
2
Auto
–
–
Backup R
I:E (I/T)
shows the adjustable alarm parameters in P SIMV mode.
Name
Min VTI
Max VTI
Table 3-10. Alarm Parameters in P SIMV Ventilation Mode
Units Min.
Value
Max.
Value
Adjustment
Resolution
Default
Value
ml ml
30
80
2000
3000
10
10
300
2000
Links
Max VTI
Min VTI
Min VTE
Max VTE ml ml
Max Rtot bpm
Min FiO
2
Max FiO
2
%
%
30
80
17
18
30
1990
3000
70
90
100
10
10
1
1
1
300
1000
OFF
OFF
OFF
Max VTE
Min VTE
Rate
Max FiO
2
Min FiO
2
Pi—INSPIRATORY PRESSURE
When Relative Pressure is set to YES in the Setup Menu, Pi allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of controlled breaths In this configuration, the sum of Pi and PEEP must not exceed 55 mbar.
When Relative Pressure is set to OFF in the Setup Menu, Pi allows you to determine inspiratory
Absolute pressure of controlled breaths. In this configuration, Pi and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
P Support—PRESSURE SUPPORT
When Relative Pressure is set to YES in the Setup Menu, P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of spontaneous breaths.
In this configuration, the sum of P Support and PEEP must not exceed 55 mbar.
3-22 Clinician's Manual
P SIMV Mode Parameters and Setting Ranges
When Relative Pressure is set to OFF in the Setup Menu, P Support allows you to determine inspiratory Absolute pressure of spontaneous breaths.
In this configuration, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
PEEP—POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the level of pressure maintained during the exhalation phase.
When Relative Pressure is set to YES in the Setup Menu, the sum of Pi or P Support and PEEP must not exceed 55 mbar.
When relative pressure is set to OFF, Pi or P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.
In leak configuration, the minimum PEEP setting is 4 mbar.
Rate—RESPIRATORY RATE
R-Rate is the rate at which the ventilator control pressure cycles are initiated, excluding apnea phases.
Rate and Insp Time are related so that if Rate is greater than 12 bpm, then Insp Time must be between 20% and 80% of the breath cycle duration as determined by Rate:
Insp Time < 0.33 x 60 /R Rate if Rate ≥ 8.
Insp Time ≤
2.4 if Rate < 8.
Note:
During apnea ventilation, the ventilator delivers controlled breaths according to a backup rate (Backup R) as long as no inspiratory trigger has been detected.
Note:
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.
Insp Time—INSPIRATORY TIME CONTROLLED
Insp Time allows you to determine the duration of the inspiratory phase of controlled breaths triggered by the ventilator and is limited to a 1:2 I:E ratio.
Backup R and Insp Time are related.
I Sens—INSPIRATORY TRIGGER SENSITIVITY
I Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.
Clinician's Manual 3-23
Operating Parameters
The sensitivity levels decrease from 0P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.
I Sens 0 (P) = Bias flow + (0.4 lpm to 0.6 lpm) (P = Pediatric use)
I Sens 1 (P) = Bias flow + (0.4 lpm to 0.8 lpm) (P = Pediatric use)
I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)
I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)
I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)
I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO
2
).
The inspiratory trigger is initiated after a time delay of between 300 ms to 2000 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 0P, 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. 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.
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.
3-24 Clinician's Manual
P SIMV Mode Parameters and Setting Ranges
I Time (Min and Max Settings)
The minimum (Min I Time) and maximum (Max I Time) duration of the inspiratory phase cannot be set in V SIMV or P SIMV mode. In both the V SIMV and P SIMV modes, the Min I Time defaults to a setting equal to RISE TIME + 300 ms and the Max I Time defaults to the lesser of 3 seconds or 30/
Rate.
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).
E Sens—EXHALATION SENSITIVITY
E sens is available in the P SIMV, V SIMV, and PSV modes. In CPAP, E Sens is defaulted to 25% and is not adjustable.
E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.
The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting.
The exhalation trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.
If the flow drop is insufficient, exhalation is automatically triggered independently of the E Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time has elapsed. For more information about maximum inspiratory time, see Min and Max I Time - Minimum/Maximum Inspiration Time.
Figure 3-9. Exhalation trigger sensitivity
Clinician's Manual x Seconds y1 Inspiration y2 Exhalation
3-25
Operating Parameters
Note:
See Chapter
, “
” for positive and negative E Sens settings.
VTI (Min and/or Max Alarm Settings)—INSPIRATORY TIDAL VOLUME
It is possible to set a Min and/or Max Tidal Volume alarm threshold for the patient’s inspired tidal volume.
This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI“ alarm) or greater than the maximum threshold set (“HIGH VTI“
.”
Min VTI and Max VTI are related and their setting must maintain a minimum difference of 20 ml between them.
It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.
VTE (Min and/or Max Alarm Settings)—EXPIRED TIDAL VOLUME
A Min and/or Max Tidal volume expired by the patient can be set but can only be used in a double-limb circuit configuration.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE“ alarm) or greater than the maximum threshold set
(“HIGH VTE“ alarm). See Chapter
, “
.”
Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between them.
VTE is displayed when ventilating with an exhalation valve.
Setting Min VTE and Max VTE is not mandatory (set to “OFF”), but the display of the measured value is always active in double-limb configuration.
Max Rtot (Max Alarm Setting)—TOTAL BREATH RATE
The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering.
Its setting is used to trigger the “HIGH RATE“ alarm. See Chapter
, “
When set, the Max Rtot threshold must always exceed the Rate setting by at least 5 bpm. If the
Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of
5 bpm.
Setting the Max Rtot is not mandatory (it can be set to “OFF“, the default setting), but the measured value is always displayed.
FiO
2
(Min and/or Max Alarm Settings)—FRACTION OF INSPIRED OXYGEN
An FiO
2
sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.
Min and Max FiO
2
thresholds can be set to trigger “LOW FiO
2
” or “HIGH FiO
2
” alarms.
3-26 Clinician's Manual
V SIMV Mode Parameters and Setting Ranges
Min and Max FiO
2
Max thresholds are related and their settings must maintain a minimum difference of 10% between the two.
Min and Max FiO
2
settings can be set to OFF if an FiO
2
sensor is not connected. Settings are automatically restored once a sensor is reconnected.
These settings are the same for all ventilation modes.
3.6
V SIMV Mode Parameters and Setting Ranges
The menus in the V SIMV (Synchronized Intermittent Mandatory Ventilation Volume) ventilation
Figure 3-10. Menus in V SIMV Ventilation Mode
shows the adjustments and limits in V SIMV mode.
Name
Vt
P Support
PEEP
Rate
Table 3-11. Ventilation Parameters in V SIMV Mode
Units
ml
Min.
Value
50
Max.
Value
2000
Adjustment
Resolution
10
Default
Value
500 cmH
2 cmH
2
O, mbar or hPa
O, mbar or hPa bpm
5
OFF
1
55
20
40
1
1
1
15
OFF
13
Links
Min VTE
Max VTE
Insp Time
PEEP
Min PIP
Max PIP
P
Support
Max PIP
Min PIP
Vt
Max Rtot
Insp Time
Clinician's Manual 3-27
Operating Parameters
Name
Insp Time
E Sens
I Sens
Rise Time
Apnea Time
– s
–
–
Table 3-11. Ventilation Parameters in V SIMV Mode
Units
s
Min.
Value
0.3
Max.
Value
2.4
Adjustment
Resolution
0.1
Default
Value
1.5
5 (-95) 95 (-5)
0P
1
1
5
4
60
5
1
1
1
25
2
2
Auto
Links
Vt
Rate
–
Rate
–
Backup R
Alarm parameters that are adjustable in the V SIMV mode menu and their adjustment limits are listed in
Name
Table 3-12. Alarm Parameters in the V SIMV Mode Menu
Units
Min PIP cmH
2
O, mbar or hPa
Min.
Value
2
Max.
Value
52
Adjustment
Resolution
1
Default
Value
2
Links
Pi
PEEP
Max PIP
Max PIP cmH
2
O, mbar or hPa
Min VTE ml
12
30
60
1990
1
10
40
300
Pi
PEEP
Min PIP
Vt
Max VTE
Max VTE
Max Rtot
Min FiO
2
Max FiO
2 ml bpm
%
%
80
17
18
30
3000
70
90
100
10
1
1
1
1000
OFF
OFF
OFF
Vt
Min VTE
Rate
Max FiO
2
Min FiO
2
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.
3-28 Clinician's Manual
V SIMV Mode Parameters and Setting Ranges
WARNING:
Ensure that the patient circuit is appropriate for the tidal volume setting (tube Ø 22 mm for adults, and Ø 15 mm for pediatric tidal volumes lower than 200 ml).
P Support—PRESSURE SUPPORT
When Relative Pressure is set to YES in the Setup Menu, P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of spontaneous breaths.
In this configuration, the sum of P Support and PEEP must not exceed 55 mbar.
When Relative Pressure is set to OFF in the Setup Menu, P Support allows you to determine inspiratory Absolute pressure of spontaneous breaths.
In this configuration, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
PEEP—POSITIVE END EXPIRATORY PRESSURE
PEEP allows you to determine the level of pressure maintained during the exhalation phase.
When Relative Pressure is set to YES in the Setup Menu, the sum of P Support and PEEP must not exceed 55 mbar.
When relative pressure is set to OFF, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.
The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.
In leak configuration, the minimum PEEP setting is 4 mbar.
Rate—RESPIRATORY RATE
Rate is the rate at which ventilator controlled breaths are triggered, excluding apnea ventilation.
Rate and Insp Time are related so that if Rate is greater than 8 bpm, then Insp Time must be 0.2 x
60 / Rate < Insp Time < 0.8 x 60 / Rate.
Note:
During apnea ventilation, the ventilator delivers controlled breaths according to a backup rate (Backup R) as long as no inspiratory trigger has been detected.
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.
Insp Time —INSPIRATORY TIME
Insp Time allows you to determine the inspiratory phase duration of ventilator controlled breaths.
For physiological and efficiency reasons, its setting is limited by those of Vt and Rate.
Clinician's Manual 3-29
Operating Parameters
The ratio Vt/Insp Time must be between 3 liters and 100 liters [3 < (Vt x 60) / (InspTime x 1000) <
100].
Note:
The Backup R value depends on the 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.
I Sens—INSPIRATORY TRIGGER SENSITIVITY
I Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath.
The sensitivity levels decrease from 0P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.
I Sens 0 (P) = Bias flow + (0.4 lpm to 0.6 lpm) (P = Pediatric use)
I Sens 1 (P) = Bias flow + (0.4 lpm to 0.8 lpm) (P = Pediatric use)
I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)
I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)
I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)
I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)
The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO
2
).
The inspiratory trigger is initiated after a time delay of between 300 ms to 2000 ms
,
depending on the preceding peak inspiratory flow.
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 0P, 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).
3-30 Clinician's Manual
V SIMV Mode Parameters and Setting Ranges
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.
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.
I Time (Min and Max)
The minimum (Min I Time) and maximum (Max I Time) duration of the inspiratory phase cannot be set in V SIMV or P SIMV mode. In both the V SIMV and P SIMV modes, the Min I Time defaults to a setting equal to RISE TIME + 300 ms and the Max I Time defaults to the lesser of 3 seconds or 30/
Rate.
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).
E Sens—EXHALATION SENSITIVITY
E Sens is available in the P SIMV, V SIMV, and PSV mode. E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.
The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting.
The exhalation trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.
If the flow drop is insufficient, exhalation is automatically triggered independently of the E Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time has elapsed. For more information about maximum inspiratory time, see Min and Max I Time - Minimum/Maximum Inspiration Time.
Note:
” for positive and negative E Sens settings.
Clinician's Manual 3-31
Operating Parameters
Figure 3-11. Exhalation trigger sensitivity
3-32 y2 Exhalation x Seconds y1 Inspiration
PIP (Min and Max Alarm Settings)—PEAK INSPIRATORY PRESSURE
A minimum and maximum pressure alarm threshold must be set.
The Min PIP (or Min Pressure) setting determines the trigger threshold for the “PATIENT DISCON-
NECTION“ alarm. See Chapter
.”
WARNING:
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
) to ensure the LOW PIP alarm is properly set.
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. See Chapter
, “
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.
VTI (Min and/or Max Alarm Settings)—INSPIRATORY TIDAL VOLUME
It is possible to set a Min and/or Max alarm threshold for the inspired tidal volume received by the patient.
VTI allows you to trigger an alarm during breath delivery if the tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI“ alarm) or greater than the maximum threshold set (“HIGH VTI“ alarm). See Chapter
.”
Clinician's Manual
V SIMV Mode Parameters and Setting Ranges
Min VTI and Max VTI are related to Vt such that Vt must be higher than Min VTI by at least 10 ml, but lower than Max VTI by at least 10 ml.
If Vt is changed, Min VTI and Max VTI are, if necessary, automatically readjusted so that the difference between them is maintained.
Setting Min VTI and Max VTI is not mandatory (set to “OFF“), but the display of the measured value is always active in a double-limb configuration.
VTE (Min and/or Max Alarm Settings)—EXPIRED TIDAL VOLUME
A double-limb patient circuit configuration must be used when setting the Min and/or Max Tidal volume alarm limits.
These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE“ alarm) or greater than the maximum threshold set
(“HIGH VTE“ alarm). See Chapter
Min VTE and Max VTE are linked to Vt such that Vt must be greater than Min VTE by at least 10 ml but lower than Max VTE by at least 10 ml.
If Vt is changed, Min VTE and Max VTE are, if necessary, automatically readjusted so that the difference between them is always maintained.
VTE is displayed when ventilating with an exhalation valve.
Setting Min VTE and Max VTE is not mandatory (each can be set to “OFF“)
,
but the measured value is always displayed using a double-limb patient circuit.
Max Rtot (Max Alarm Setting)—TOTAL BREATH RATE
The maximum rate threshold set is used to monitor and alarm for ventilator autotriggering.
The alarm setting is used to trigger the “HIGH RATE” alarm. See Chapter
.”
When set, the Max Rtot threshold must always exceed the Backup Rate by 5 bpm; the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.
Setting the Max Rtot is not mandatory (it can set to “OFF”)
,
but the measured value is always displayed.
FiO
2
(Min and/or Max Alarm Settings)—FRACTION OF INSPIRED OXYGEN
An FiO
2 sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.
Min and Max FiO
2 thresholds can be set to trigger “LOW FiO
2
” or “HIGH FiO
2
” alarms.
Min FiO
2
and Max FiO
2
thresholds are related and their settings must maintain a minimum difference of 10% between the two.
Min and Max FiO
2
settings can be set to OFF if an FiO
2
sensor is not connected. Settings are automatically restored once a sensor is reconnected. These settings are the same for all ventilation modes.
Clinician's Manual 3-33
Operating Parameters
3.7
FiO
2
For Various Oxygen and Ventilator Settings
Figure 3-12. Inhalation flow (LPM) = Volume (L) x 60 / Inspiratory time (S).
x y Inhalation flow (l/min) O
2 flow (l/min)
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 analyzer with minimum and maximum concentration alarms. Always measure the delivered oxygen with a calibrated oxygen analyzer (FiO
2
kit) that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
3-34 Clinician's Manual
4 Monitored Parameters
During ventilation, ventilator parameters measured or calculated are highlighted in the menus used for setting the ventilation parameters, the alarms, and the waveforms.
•
In addition to the display of monitored ventilation parameters, ventilation is displayed graphically, as follows:
Pressure bar chart, in the ventilation parameters setting menu
•
Pressure and flow rate waveforms, according to time, in the graphic menu (if waveforms was selected in the preferences menu). See Chapter
.”
Note:
To monitor patient oxygen levels use an external sensor/alarm.
4.1
Digital Monitoring
•
•
•
The ventilation parameters monitored or calculated are highlighted in each of the main menus:
Ventilation menu (
,
)
Alarm menu (
)
Waveform menu (
,
)
Figure 4-1. Ventilation Menu: Pressure Leakage Configuration Modes (CPAP, PSV S, PSV ST, PCV, P A/C)
4-1
Monitored Parameters
Figure 4-2. Ventilation Menu: Pressure Valve Configuration Modes (PSV S, PSV ST, PCV, P A/C)
Figure 4-3. Ventilation Menu: Volume Mode (CV, V A/C, SIMV)
Figure 4-4. Alarm Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV, P A/C)
4-2 Clinician's Manual
Clinician's Manual
Figure 4-5. Alarm Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C)
Digital Monitoring
Figure 4-6. Alarm Menu: Volume Modes (CV, V A/C, SIMV)
Figure 4-7. Waveform Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV, P A/C)
4-3
Monitored Parameters
Figure 4-8. Waveform Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C)
Figure 4-9. Waveform Menu: Volume Mode (CV, V A/C, SIMV)
Monitored parameter values are updated every two breath cycles and are displayed in the form
Figure 4-10. Monitored Parameter Inserts
4-4
1
Parameter name
2
Measured or calculated value
3
Unit of measure
Clinician's Manual
Digital Monitoring
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. Display Showing Unavailable Parameter Values
Inspiratory Trigger
During each inspiration phase triggered by the patient, the Inspiratory Effort Detected symbol is displayed beside the cycling I:E ratio in the ventilation, alarm, or waveform menus (see
The patient triggers the ventilator by inhaling the amount of flow and the ventilator responds by delivering either a pressure-based or volume-based breath.
Figure 4-12. Inspiratory Effort Detected Indicator
Clinician's Manual 4-5
Monitored Parameters
Displayed Monitored Parameters
Monitored Parameters Display
Exhaled Tidal Volume VTE
Table 4-1. Displayed Monitored Parameters
Description
Patient exhaled flow is measured by the exhalation flow transducer and that measurement is used to calculate volume (the flow transducers do not directly measure volume).
The displayed value is updated at each inspiration, but is available only in the double limb patient circuit configuration.
Exhalation Time
Fraction of Inspired
Oxygen
I:E Ratio
Inspiratory Tidal Volume
Inspiratory Time
Leak
Minute Volume lnspiratory
Pressure
Positive End Expiratory
Pressure
Rate
Peak Airway Pressure
E Time Exhalation time measured.
The displayed value (waveform only) is updated at each inspiration.
FIO
2
Percentage of oxygen inspired by the patient.
The displayed value (waveform only) is updated at each inspiration.
I:E
VTI
Ratio of inspiratory time measured to exhalation time measured.
The displayed value is updated at each inspiration.
Flow delivered by the ventilator to the patient at each inspiratory phase is measured by the inspiratory transducer and that measurement is used to calculate volume (the flow transducers do not directly measure volume).
The displayed value is updated at each inspiration.
Currently when a Pressure Controlled or Pressure Support breath is delivered in valve ventilation and a leak is present, the ventilator will increase flow to reach the pressure target. The monitored VTI in Pressure Controlled or Pressure Support breaths reflects the amount of flow the ventilator delivers from the outlet port during inhalation. The monitored value will increase (possibly to an abnormally high number) when a leak is present. This displayed value is not what is delivered to the patient.
I Time Inspiratory time measured.
The displayed value (only in waveform menu) is updated at each exhalation.
Leak Available only in the single-limb patient circuit in leak configuration.
The displayed value (only in waveform menu) is updated at each inspiration.
M Vol Flow delivered at each breath to the patient is measured by the inspiratory transducer and that measurement is used to calculate minute volume (Vt x Rtot) (the flow transducers do not directly measure volume).
The displayed value is updated at each exhalation.
Pi Highest circuit pressure during each inspiration phase measured with the proximal pressure sensor.
The displayed value is updated at each exhalation.
PEEP End exhalation pressure is measured by the proximal pressure sensor.
The displayed value is updated at each inspiration.
Rtot Total number of breaths measured per minute.
The displayed value is based on each breath and is updated at each inspiration.
Paw The average peak pressure during the inspiratory phase, measured by each cycle and over the previous 24 hour period.
4-6 Clinician's Manual
Bargraph Display
4.2
Bargraph Display
In the ventilation menu, the highlighted bargraph dynamically displays pressures established throughout the breath cycle (
).
Figure 4-13. Bargraph Display
The Pi value reached during a cycle is represented by a line at the top of the bargraph (
, 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 (
4.3
Waveform Display
•
The waveform screen is only accessible during ventilation from the alarm parameters screen using the MENU key. Its display has been configured in the Preferences menu (see Chapter
”).
The Pressure waveform and the Flow waveform are referenced to Time. On these waveforms, the maximum Pressure and Flow lines are updated each time the graphic window is refreshed (every two breath cycles).
•
The scales for Pressure and Flow automatically adjust according to the maximum levels measured over the last three cycles. The time scale also adjusts automatically according to the breath rate frequency, which allows the display of two consecutive cycles.
The waveform screen is shown in
Clinician's Manual 4-7
Monitored Parameters
Figure 4-14. Waveform Screen
4-8
•
1
Ventilation Mode
2
Pressure over last two cycles
1
3
Maximum Flow over last two cycles
4
5
Frozen waveform symbol
Inspiratory trigger symbol
1.
Pressure and flow scales are 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.
To freeze the waveform trace:
•
Press the DOWN key.
The waveform display is frozen.
The display of the last numerical monitored values remains fixed.
•
The Freeze Waveform symbol is displayed in the upper part of the screen.
•
To unfreeze the waveform trace:
•
Press the UP key.
Waveform tracing continues.
The display of the numerical values monitored is refreshed.
•
The Freeze Waveform symbol disappears.
The Freeze Waveform function remains active even when changing the ventilation or alarm menu, or stopping ventilation. Accessing the Preferences Menu or the Alarm logs screen while the Freeze Waveform function is active deactivates this function.
To dismiss the waveform screen manually:
Press the MENU key.
Clinician's Manual
Ventilation Report
•
The waveform screen is automatically dismissed:
When a High priority alarm is triggered.
•
When you press the VENTILATION ON/OFF key to stop ventilation.
4.4
Ventilation Report
The Ventilation Report is available in the Preferences Menu (see Chapter
The Ventilation Report updates daily at 8 a.m. and shows the average readings from the previous
24 hours. See
Figure 4-15. Ventilation Report
Note:
The values displayed in the Ventilation Report are reinitialized when the software is updated or the patient counter is reset to zero.
The following data is displayed in the Ventilation Report:
Vent Time—Ventilation Time
The ventilation duration data is based on the patient counter and shows the total ventilation time in hours and minutes over the previous 24 hour period.
VTI—Inspired Tidal Volume
When ventilating with an exhalation valve, the VTI is the average inspired tidal volume during each ventilation cycle over the previous 24 hour period.
When ventilating in leak mode, the VTI is the average volume delivered by the ventilator during each ventilation cycle over the previous 24 hour period.
Clinician's Manual 4-9
Monitored Parameters
VTE—Exhaled Tidal Volume
When ventilating with a double limb circuit configuration and an exhalation valve, the VTE is the average exhaled volume during each ventilation cycle over the previous 24 hour period.
In a single-limb circuit configuration this value is not measured.
Paw—Peak Airway Pressure
The Peak Airway Pressure is the average peak pressure during the inspiratory phase, measured by each cycle and over the previous 24 hour period.
Rate—Respiratory Rate
The Respiratory Rate is the average of the total respiratory frequency of the patient and the ventilator measured over the previous 24 hour period.
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.
Apnea Ti—Apnea Time
Accumulated apnea time over the previous 24 hour period.
Spont Cyc—Spontaneous Cycling
This is the percentage of ventilation cycles initiated by the patient and the ventilator over the previous 24 hour period.
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.
4-10 Clinician's Manual
5 Alarms and Troubleshooting
WARNING:
Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
WARNING:
When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
•
The alarms or faults generated by your Puritan Bennett™ 560 Ventilator are classified into two categories: ventilation (or utilization) alarms
• technical faults
Alarms indicate events likely to affect the ventilation in the short term and necessitate rapid intervention (see section
on page
).
Some of the ventilator alarms are adjustable, depending on ventilation modes (see Chapter
,
”). Automatic, non-adjustable alarms also exist to create a safety net for safer patient ventilation.
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
Note:
Setting any alarm limits to OFF or to extreme high or low values can cause the associated alarm not to activate during ventilation, which reduces its efficacy for monitoring the patient and alerting the caregiver to situations that may require intervention.
Note:
All configurable alarm settings are recorded in the ventilator’s non-volatile internal memory, and are retained when powering down or in the event of a total loss of power.
Technical faults do not directly affect machine operation. Therefore, the user is not alerted to technical faults. Only authorized and trained technicians may consult the maintenance menu
(see the Puritan Bennett 560 Service Manual).
5-1
5-2
Alarms and Troubleshooting
5.1
Alarm Level of Priority
•
•
•
The alarm hierarchy for signaling the level of alarm criticality is listed below.
Very High Priority (VHP): Immediate critical situation; ventilation is impossible:
Continuous Sound Signaling / With or Without Continuous Red LED Illumination / With or Without
Message / With or Without Display Lighting (it is possible for an alarm condition to occur that may not have both a message and lighting).
High Priority (HP): Critical situation in the short term; ventilation is potentially compromised:
High Speed Intermittent Sound Signaling / Flashing Red LED Illumination / With Message / With
Display Lighting
Medium Priority (MP): Critical situation in the long term; ventilation is not affected in the short term:
Medium Speed Intermittent Sound Signaling / Flashing Yellow LED Illumination / With Message / With
Display Lighting
Note:
There are currently no Low Priority (LP) Alarms.
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.
5.2
Alarm Display
•
•
•
During operation, when an alarm is activated:
One of the red or yellow alarm indicators to the left of the ALARM CONTROL key illuminates and flashes.
An alarm tone sounds.
A message is displayed and flashes in reverse video at the bottom of the Ventilation Menu or Alarm
Menu.
Clinician's Manual
Figure 5-1. Alarm Displays
Alarm Display
1 Alarm Control Key
1 Alarm Messages
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.
Clinician's Manual 5-3
Alarms and Troubleshooting
5.3
Alarm Logs Menu
All alarms are recorded in the ventilator’s non-volatile internal memory at the time they are activated, and are retained when powering down or in the event of a total loss of power.
The Alarm Logs menu is used to display the last eight (8) alarms activated, along with their date and time of activation.
To access the Alarm Logs menu, do the following:
1.
Press the MENU key to access the alarm setting menu (if this is not the menu currently displayed).
2.
Press the DOWN key until the cursor is on the “Alarm Logs” line at the bottom of the page. The display appears as follows:
Figure 5-2. Accessing Alarm Logs Menu
3.
Press the ENTER key. The Alarm Logs screen is displayed.
Figure 5-3. Displaying the Alarm Logs Screen
5-4
Note:
When no alarm has been activated, “NO DATA” is displayed on the screen (see graphic below).
Clinician's Manual
Pausing the Audible Portion of Alarms
Figure 5-4. Alarm Logs Display when No Alarm Activated
For more information on the “USER’S CLEAR ALERTS” line, see section
.
To dismiss the Alarm Logs screen manually:
Press the ENTER key when the cursor is on the “Back” line.
•
The Alarm Logs screen is dismissed automatically:
After 15 seconds if no keyboard action is detected
•
When a High Priority alarm is triggered
Note:
Only qualified service personnel may access all alarms and events recorded by the ventilator. Qualified personnel should see the Puritan Bennett™ 560 Service Manual for further information.
5.4
Pausing the Audible Portion of Alarms
•
You may pause the audible portion of alarms for 60 seconds at a time.
To pause the audible portion of activated alarms:
•
Press the ALARM CONTROL key.
The audible portion of all activated alarms is paused.
The visual portions (light indicator and message) of activated alarms remain visible.
•
The Audio Paused symbol is displayed at the top right of the screen while the audio pause function is active
Clinician's Manual 5-5
Alarms and Troubleshooting
Figure 5-5. Pausing the Audible Portion of Alarms
5-6
If several alarms are activated at the same time, pressing the ALARM CONTROL key affects all current alarms.
•
The audible portion of activated alarms is automatically reactivated:
After 60 seconds, if the cause(s) of the alarm(s) persist(s)
•
Whenever a new alarm is activated
Note:
If a key is stuck or held down for 45 seconds a keypad alarm will occur.
5.5
Pausing/Resetting Alarms
WARNING:
Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. The audible alarm vents located at the front of the device should never be obstructed. The alarm can be paused with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared.
WARNING:
When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
Some alarms are not automatically canceled 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).
Clinician's Manual
Reactivating Alarms
To manually pause an alarm, proceed as follows:
•
Press the ALARM CONTROL key twice.
The alarm is paused until the alarm condition is corrected and the condition reoccurs: the audible portion, light indicator, and message are all halted (for the alarms that can be paused manually).
•
The Alarm Paused symbol is displayed at the top right of the Ventilation, Alarms, and Waveforms screens. See
Figure 5-6. Manually Pausing Alarms
When no other alarms are currently activated, the last alarm canceled 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. See section
, “
” on page
To manually reset the High Pressure Alarm, proceed as follows:
Press the ALARM CONTROL key twice. The visual alarms will be reset.
5.6
Reactivating Alarms
Alarms that have been paused and whose activation conditions continue to exist can be reactivated.
To reactivate alarms, proceed as follows:
1.
Press the MENU key to access the Alarm Setting menu, if this is not the menu currently displayed.
2.
Press the DOWN key to position the cursor on the “Alarm Logs” line, if this is not already the case.
See the following graphic:
Clinician's Manual 5-7
Alarms and Troubleshooting
Figure 5-7. Reactivating Alarms
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. See the following graphic:
Figure 5-8. Alarm Logs
5-8
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.
Clinician's Manual
Overview of Alarms
5.7
Overview of Alarms
Note:
The message: “*IF PERSISTS RESTART/SRVC” will occur only if the alarm condition continues for longer than
30 seconds.
Table 5-1. Overview of Alarms
Cause/Ventilator Response Alarm Message Priority Audio
Paused
Avail.
Alarm
Paused
Avail.
AC POWER
DISCONNECTION
APNEA
Cut-off of the AC (mains) power supply.
Alarm activation occurs:
• After 5 seconds if ventilation is stopped
• At the start of a ventilation cycle when ventilation is in progress.
Consequence: switch over to external DC power supply if present; if not, to the internal battery.
No inspiratory trigger detected by the ventilator after the apnea time set in PSV, CPAP, P SIMV and V SIMV modes.
Automatically clears itself after two successive patient breaths.
Ventilator has detected an internal battery fault.
Consequence: the internal battery is disabled from use.
No internal battery detected.
BATTERY FAULT1
RESTART/SRVC
BATTERY FAULT2
RESTART/SRVC
BUZZER FAULT1
RESTART/SRVC
Defective operation of the buzzers.
BUZZER FAULT2
RESTART/SRVC
BUZZER FAULT3
RESTART/SRVC
BUZZER LOW
BATTERY
CALIBRATE FiO
2
CALIBRATION FAIL
Failure detected in the Very High Priority buzzer.
Consequence: no audible alarm in case of POWER
SUPPLY LOSS alarm.
Battery Charge Failure due to incorrect voltage. Contact your service representative for assistance.
Buzzer Battery Failure. The Battery Buzzer Voltage is too low.
Internal technical problem that prevents the battery sounding the POWER SUPPLY LOSS alarm.
An FiO
2
sensor is detected and has not been calibrated.
Failure of one calibration point of the internal exhaled flow sensor.
Consequence: failed calibration point is replaced by the default point.
MP
MP
MP
MP
MP
MP
HP
MP
MP
MP
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes – except for CPAP
Yes
No
No
Yes
No
Yes
Yes
Yes
Clinician's Manual 5-9
Alarms and Troubleshooting
Alarm Message
Table 5-1. Overview of Alarms (Continued)
Cause/Ventilator Response Priority
CHECK BATTERY
CHARGE
IF PERSISTS RESTART/
SRVC
Internal battery charging failure.
Consequence: charging of the internal battery impossible.
CHECK EXH VALVE*
*IF PERSISTS
RESTART/SRVC
CHECK EXH VALVE
PRESSURE
CHECK FiO
SENSOR
2
Inspired tidal volume during exhalation
< 20% of Inspired tidal volume and Inspired tidal volume
> 20 mL.
Exhalation valve obstructed.
Internal ventilation fault related to exhalation valve detection sensor (pressure sensor).
FiO
2
measurement is less than 18%.
Recalibrate or change FiO
2
sensor.
1. Loss of signal from the proximal pressure sensor
CHECK PROXIMAL
LINE1*
*IF PERSISTS
RESTART/SRVC
CHECK REMOTE
ALARM
Consequence: switch to internal pressure sensor for the pressure measurement.
Alarm activation occurs:
In the event of signal loss (1):
After one ventilation cycle or
In the event of signal loss (2) and after the 17th breath cycle:
After 17 seconds for P A/C and V A/C modes, or after the maximum time between 17 seconds and Apnea Time + 4 seconds for CPAP, PSV, P SIMV, and V SIMV modes
Failure of ventilator remote alarm relay circuit.
CHECK
SETTINGS
CONNECT VALVE
OR CHANGE PRESS
CONTROLLED
CYCLES
COOLING FAN
RESTART/SRVC
Alarm activation occurs:
• Systematically after software versions have changed.
• Loss of memorized parameters
Consequence:
• Locking Key disabled
• Out-of-range settings are replaced by their default values
No exhalation valve connected with PEEP set to less than
4 mbar or
Pi set to more than 30 mbar when relative pressure is set to OFF.
The ventilator is delivering apnea ventilation at set back up rate.
Ventilator cooling fan operating speed not suited to the internal ambient temperature of the device.
MP
MP
MP
MP
HP
NA
MP
HP Yes
HP Yes
HP Yes
Yes
Yes
Yes
Yes
NA
Yes
Audio
Paused
Avail.
Alarm
Paused
Avail.
Yes No
No
Yes
Yes
No
NA
Yes
No
Yes
No
5-10 Clinician's Manual
Overview of Alarms
Alarm Message
Table 5-1. Overview of Alarms (Continued)
Cause/Ventilator Response Priority
DC POWER
DISCONNECTION
Cut-off of the external DC power supply.
Consequence: switch-over to the internal battery.
Failure in the 24 V power supply.
DEVICE FAULT3
RESTART/SRVC
DEVICE FAULT5
RESTART/SRVC
DEVICE FAULT7
RESTART/SRVC
DEVICE FAULT9
RESTART/SRVC
DEVICE FAULT10
RESTART/SRVC
DEVICE FAULT11
RESTART/SRVC
DEVICE FAULT12
RESTART/SRVC
DEVICE FAULT13
RESTART/SRVC
E SENS FAULT OR
CIRC LEAK
Detection of a fault in the electrical power supply system.
Alarm activation occurs:
Once the ventilator is on for at least 3 seconds, and a power supply fault is detected for at least 5 seconds thereafter.
Consequence: the internal battery capacity is not displayed beside the battery symbol.
Detection of a fault in internal voltage measurement.
POST RAM Error. RAM Read/Write does not match memory setting.
POST FLASH Checksum Error. Startup FLASH computed checksum does not match memory setting.
POST EEPROM Error. Startup EEPROM does not match memory setting.
POST Reference Voltage Error. 5V or 10V reference voltage error.
Software Version Error
EMPTY BATTERY
EXH VALVE
LEAKAGE
At least four of the last six breaths within the last minute are terminated by time.
Internal battery capacity < 10 min. or 3%.
(battery voltage < 22.5V)
Consequence: ventilation comes to a halt.
Abnormally high expired flow during the inspiratory phase of three consecutive breaths (in double-limb setup).
Alarm activation occurs:
After three consecutive breaths.
No FiO
2
sensor detected and the FiO
2
alarm is active. FiO
2
SENSOR
MISSING
HIGH / LOW BATTERY
TEMP*
*IF PERSISTS
RESTART/SRVC
Battery temperature out of tolerance.
Consequence: battery charging stops.
HIGH FiO
2
The level of oxygen delivered by the ventilator exceeds the Max FiO
2
level set.
MP
HP
MP
MP
HP
MP
MP
Yes
VHP
VHP
MP
HP
VHP
VHP
VHP
HP No
No
No
Yes
Yes
No
No
No
Yes
Audio
Paused
Avail.
Yes
Alarm
Paused
Avail.
Yes
Yes No
Yes
No
Yes Yes
Yes Yes
Yes No
No
No
No
No
No
No
No
No
Clinician's Manual 5-11
Alarms and Troubleshooting
Alarm Message
Table 5-1. Overview of Alarms (Continued)
Cause/Ventilator Response Priority Audio
Paused
Avail.
HIGH INT TEMP
COOL VENT*
*IF PERSISTS
RESTART/SRVC
Device internal ambient temperature out of tolerance range.
MP
HIGH LEAKAGE
HIGH PRESSURE
The LEAK estimated by the ventilator exceeds the Max
LEAK alarm threshold.
MP
• 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, if Inspiratory Pressure is higher than (P Support or P Control + PEEP) +
5 mbar up to 29 mbar or + 10 mbar over 30 mbar during three consecutive cycles.
or
• In PSV or CPAP mode and P Support is set to off, if Inspiratory Pressure is higher than PEEP + 10 mbar during three consecutive cycles.
Alarm activation occurs:
• After three consecutive breaths.
Consequence:
• Switch to exhalation phase.
HP
Note:
When alarm condition clears, alarm priority indicator must be manually reset by pressing the key.
HIGH RATE
HIGH VTE
Rate measured greater than Max Rtot set during three consecutive breaths.
Alarm activation occurs:
• After three consecutive breaths.
Expired tidal volume greater than Max VTE set during three consecutive breaths (in double-limb setup).
Alarm activation occurs:
• After three consecutive breaths.
HIGH VTI
INSP FLOW RESTART/
SRVC
Inspired tidal volume greater than Max VTI set during three consecutive breaths in PSV, CPAP, P A/C, P SIMV, and V SIMV modes.
Alarm activation occurs:
• After three consecutive breaths.
Inspiratory flow is constant (
1 lpm) with normal turbine temperature and speed conditions. Contact your service representative for assistance.
INTENTIONAL VENT
STOP
Ventilation has been stopped voluntarily by the caregiver or patient.
Keyboard key held down for more than 45 seconds.
KEYPAD FAULT
RESTART/SRVC*
*IF PERSISTS
RESTART/SRVC
MP
MP
HP Yes
HP
HP
Yes
Yes
Yes
Yes
Yes
Yes
HP No
Yes
Alarm
Paused
Avail.
Yes
No
No
(The visual portion of the alarm may be paused)
No
No
No
No
Yes
No
5-12 Clinician's Manual
Overview of Alarms
Alarm Message
Table 5-1. Overview of Alarms (Continued)
Cause/Ventilator Response Priority
LOW BATTERY
LOW FiO
LOW VTE
LOW VTI
NO
2
PROXIMAL LINE2*
*IF PERSISTS
RESTART/SRVC
OCCLUSION
CHECK CIRCUIT*
Internal battery capacity < 30 min. or 8%.
The level of oxygen delivered by the ventilator is below the Min FiO
2
level set.
Expired tidal volume less than Min VTE set during three consecutive breaths (in double-limb setup).
Alarm activation occurs:
After three consecutive breaths.
Inspired tidal volume less than Min VTI set during three consecutive breaths in PSV, CPAP, P A/C, P SIMV and
V SIMV modes.
Alarm activation occurs:
After three consecutive breaths.
Proximal pressure < 0.6 mbar for 100 ms during inspiration phase of third breath cycle.
Ventilator response: Switch to internal pressure sensor for pressure measurement.
Occurs in VALVE configuration when the tidal volume is measured below 20 ml during three consecutive breaths for PSV, CPAP, PA/C and P SIMV modes.
Alarm activation occurs after three consecutive breaths if tidal volume is less than 20 mL.
*IF PERSISTS
RESTART/SRVC
OCCLUSION
CHECK CIRCUIT
PATIENT
DISCONNECTION*
*IF PERSISTS
RESTART/SRVC
Occurs in LEAK configuration when the LEAK level is not sufficient to flush the CO
2
from patient exhalation. The built-in LEAK in the mask may be obstructed.
The built-in leak for the mask is or not sufficient for the settings.
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 + Insp time) in
P SIMV and V SIMV mode.
If the flow is greater than 130 lpm 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 (Pi + PEEP) - 20%.
HP
MP
MP
MP
MP
Yes
Yes
Yes
HP Yes
HP Yes
HP Yes
Audio
Paused
Avail.
Yes
Yes
Alarm
Paused
Avail.
No
No
No
No
No
No
No
No
Clinician's Manual 5-13
Alarms and Troubleshooting
Alarm Message
Table 5-1. Overview of Alarms (Continued)
Cause/Ventilator Response Priority
POWER FAULT
RESTART/SRVC
Detection of a fault in the electrical power supply system.
POWER SUPPLY LOSS
(no message)
1. Electrical power supply to the machine is interrupted with the I/O switch when ventilation is in progress or
2. Battery fully discharged when it was the only source of power to the ventilator.
Consequence: ventilation stops immediately. Ventilation restarts immediately when the switch is pressed in case 1
(above) or after restoration of the AC or DC supply in case
2 (above).
PRES SENS FLT1
RESTART/SRVC
PROX SENS FLT2
RESTART/SRVC
REMOVE VALVE
CPAP MODE
Faulty internal pressure sensor signal.
Alarm activation occurs:
• After 15 seconds.
Faulty proximal pressure sensor signal.
Alarm activation occurs:
• After 15 seconds.
The ventilation settings are not compatible with the type of patient circuit used.
Remove exhalation valve to start CPAP ventilation.
REMOVE VALVE OR
CHANGE PRES
TURB OVERHEAT
RESTART/SRVC
The ventilation settings are not compatible with the type of patient circuit used.
With a valve circuit, the difference between Pi and PEEP should not be less than 5 mbar.
SOFTWARE VERSION
ERROR
Detection of a wrong software version.
Turbine speed too low and temperature too high.
Consequence: ventilation stops immediately and O2 supply stops.
UNKNOWN BATTERY
The internal battery is not recognized as a Puritan Bennett™ product battery.
VALVE MISSING
CONNECT VALVE
VTI NOT
REACHED*
*IF PERSISTS
RESTART/SRVC
Connect exhalation valve to start ventilation in V A/C or
V SIMV / P SIMV modes.
Measurement and calculation of tidal volume do not match Vt set during six consecutive breaths in VOL inspired and V SIMV modes.
Alarm activation occurs:
After six consecutive breaths – once the ventilator has reached its performance limits.
MP
VHP
HP Yes
MP
HP
HP
MP
HP
Audio
Paused
Avail.
Yes
No—
Alarm
Cancel
Only
Yes
Yes
Yes
NA NA
HP No
Yes
Yes
HP Yes
Alarm
Paused
Avail.
Yes
No—Alarm
Cancel Only
No
Yes
No
No
No
NA
No
No
No
5-14 Clinician's Manual
Troubleshooting
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.
WARNING:
To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator, only personnel authorized and qualified by Covidien should attempt to service or make authorized modifications to the Puritan Bennett 560 Ventilator.
5.8.1
Alarms
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.
WARNING:
When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
Note:
The ventilator screen must be unlocked before setting and parameters can be changed.
Table 5-2. Alarms and Corrective Actions
Possible Reason(s) For The Alarm Event Alarm Message or
Symptom
Corrective Action(s)
AC (“mains”) power source cut off.
AC POWER
DISCONNECTION Starting with 12 – 30 VDC external power supply.
Current-limiting fuse of the device blown.
Cancel the alarm then check the supply cable and/or the effective availability of a voltage on the AC power
(“mains”) port.
Cancel the alarm.
Replace the ventilator and call for the maintenance technician.
Clinician's Manual 5-15
Alarms and Troubleshooting
Alarm Message or
Symptom
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s)
APNEA
BATTERY FAULT1
RESTART/SRVC
BATTERY FAULT2
RESTART/SRVC
BUZZER FAULT1
RESTART/SRVC
BUZZER FAULT2
RESTART/SRVC
BUZZER FAULT3
RESTART/SRVC
BUZZER LOW
BATTERY
CALIBRATE FiO
2
Patient’s breathing effort less than the Sensitivity control setting.
Ensure the patient is breathing and adjust the inspiratory setting appropriately based on patient’s respiratory needs.
Patient apnea.
Defective sensors.
Battery problem that prevents it from operating.
Internal battery missing or not detected.
Examine the patient for breathing effort and stimulate if necessary.
If patient status has changed adjust the ventilator settings based on patient’s respiratory needs.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Defective operation of the buzzers.
Consequence: no audible tone when an alarm is activated.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Internal technical problem that prevents the very high priority “POWER SUPPLY LOSS” alarm from triggering.
Ensure that the protective cover over the I/O switch located on the rear of the device is intact and functioning properly. This cover helps prevent accidental pressing of the I/O switch and stoppage of the ventilation.
Ensure that the device is stabilized.
Call your customer service representative.
Internal technical problem that prevents the battery from correctly charging.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Connect the ventilator to an AC power source and power on using the I/O switch located on the rear of the ventilator.
Internal technical problem that prevents the battery warning buzzer from sounding POWER SUPPLY LOSS alarm.
Allow the ventilator to charge for a minimum of15 minutes and up to 2 hours.
If alarm persists, restart ventilator to see if alarm clears.
If not, contact Covidien or a local Covidien representative.
An FiO
2
sensor is detected and has not been calibrated.
Calibrate FiO
2
sensor.
5-16 Clinician's Manual
Troubleshooting
Alarm Message or
Symptom
CALIBRATION FAIL
Incorrect circuit type selected in the Preferences menu.
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event
Too large a difference between a calibration point and its tolerance range.
Restart calibration.
Corrective Action(s)
There may be a leak in the circuit. Ensure an approved circuit is in use (see circuit documentation).
Verify the circuit selection in the Preferences matches the circuit in use.
CHECK BATTERY
CHARGE
CHECK
EXH VALVE
Exhalation block defective or not properly aligned.
Defective exhalation flow sensor.
Battery charging impossible.
Obstruction or abnormal damage of the exhalation valve.
Excessive moisture in the exhalation block.
Defective connection or defective exhalation valve tubing.
Defective inspiratory flow sensor.
Reset alarm message and ensure all connections are secure, verify circuit integrity, and verify the exhalation block is properly seated.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Do not disconnect the ventilator from the AC power supply. Ensure that the power cable is installed according
to the instructions in Chapter
so that the power cable cannot be involuntarily disconnected.
In the event the internal battery capacity is low, use an alternate device to ventilate the patient.
Call your customer service representative.
Clean or replace the exhalation valve and/or its control tube.
Remove moisture from exhalation block and valve.
Verify exhalation valve is seated properly.
Reduce temperature of the humidifier.
Reconnect the valve or replace the exhalation valve and/ or the exhalation valve pilot pressure tube.
Have a qualified technician replace the defective component(s) and call your customer service representative.
CHECK EXH VALVE
PRESSURE
*IF PERSISTS
RESTART/SRVC
The exhalation valve may not be detected by the ventilator when ventilation is started.
Or the exhalation valve may be falsely detected when ventilation is started.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
CHECK FiO
2
SENSOR FiO
2
measured is less than 18%.
Check that FiO
2
sensor is properly connected or
Recalibrate FiO
2
sensor or
Replace FiO
2 sensor.
No connection of the proximal pressure tube when ventilation starts.
Reconnect the proximal pressure line.
CHECK PROXIMAL
LINE1*
Proximal pressure line disconnected or obstructed.
Reconnect the connection line or replace it if obstructed.
Check for moisture or occlusion of the proximal line.
Reduce humidifier temperature.
Switch to a heated wire circuit.
Defective proximal pressure sensor or internal leak of the machine.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component(s) and call your customer service representative.
Clinician's Manual 5-17
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s) Alarm Message or
Symptom
CHECK REMOTE
ALARM
CHECK SETTINGS
CONNECT VALVE
OR CHANGE PRESS
CONTROLLED
CYCLES
COOLING FAN
RESTART/SRVC
DC POWER
DISCONNECTION
Nurse Call or remote alarm system is disconnected.
Relay control voltage problem.
Loss of memorized parameters.
Software versions have changed.
The ventilation settings are not compatible with the type of patient circuit used.
No exhalation valve connected with PEEP set to less than 4 mbar or
Pi set to more than 30 mbar when relative pressure is set to OFF.
Connect exhalation valve
Decrease Pi to less than 30 mbar in absolute pressure.
Increase PEEP to more than 3 mbar.
Note:
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
The ventilator is delivering apnea ventilation at set back up rate.
Check that the patient circuit is correctly attached and the patient is correctly ventilated.
Operating speed of the cooling fan not properly adjusted for the internal ambient temperature of the device.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
12 – 30 VDC power supply cut off when there is no
AC (“mains”) power supply.
Cancel the alarm then check the supply wiring and/or the effective availability of voltage on the external source.
Replace the ventilator and call your customer service representative.
Ventilator’s current-limiting fuse blown.
Connect the Nurse Call or remote alarm cable to the ventilator.
Carefully monitor the patient to detect possible alarm triggering and call for the maintenance technician.
Check and adjust the prescribed parameters, if necessary.
Check and adjust the prescribed parameters, if necessary.
DEVICE FAULT3
IF PERSISTS RESTART/
SRVC
24 V supply failure.
DEVICE FAULT5
IF PERSISTS RESTART/
SRVC
Internal problem in the electrical power supply.
DEVICE FAULT7
IF PERSISTS RESTART/
SRVC
Internal technical problem.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
DEVICE FAULT9
IF PERSISTS RESTART/
SRVC
POST RAM Error. RAM Read/Write does not match memory setting.
If patient has been disconnected, reconnect patient to reset the fault.
If persists restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
DEVICE FAULT10
IF PERSISTS RESTART/
SRVC
POST FLASH Checksum Error. Startup FLASH computed checksum does not match memory setting.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
5-18 Clinician's Manual
Troubleshooting
Alarm Message or
Symptom
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event
DEVICE FAULT11
IF PERSISTS RESTART/
SRVC
POST EEPROM Error. Startup EEPROM does not match memory setting.
Corrective Action(s)
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
DEVICE FAULT12
IF PERSISTS RESTART/
SRVC
POST Reference Voltage Error. 5V or 10V reference voltage error.
DEVICE FAULT13
IF PERSISTS RESTART/
SRVC
Incorrect software version detected.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
EMPTY BATTERY
E SENS FAULT
OR CIRC LEAK
Internal battery capacity is less than 10 min. (or 3%)
– battery operation overextended.
Reconnect the device to an AC power outlet, connect it to an external DC power source, or replace the battery.
Reminder: the internal battery can be charged only when the ventilator connected to an AC power supply.
Note:
Leak in the patient circuit, leak in patient artificial airway or vented mask interface.
E sensitivity setting not properly adjusted
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Check and properly connect the patient circuit connections.
Minimize the leak.
Ensure O2 connector is removed.
Reduce inspiratory time.
Increase E-Sensitivity setting.
Check tracheotomy cuff.
Refit mask.
Use non-vented mask.
Check E Sensitivity setting
Note:
EXH VALVE LEAKAGE
FiO
2
SENSOR
MISSING
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Large leakage detected on the patient circuit return limb during the inspiratory phase.
Replace the exhalation valve and/or its control tube.
Contaminated or defective exhalation flow sensor.
There is no FiO
2
sensor and FiO
2
alarms are active.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component(s) and call your customer service representative.
If oxygen is to be delivered to the patient, connect FiO
2 sensor.
If no oxygen is to be delivered to the patient, deactivate
FiO
2
alarms.
Clinician's Manual 5-19
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s) Alarm Message or
Symptom
HIGH FiO
2
HIGH INT TEMP
COOL VENT
The level of oxygen being delivered to the patient is higher than the Max FiO
2
limit set.
Check the level of oxygen corresponds to the patient’s prescription or
Increase the FiO
2
alarm threshold.
Note:
Internal ambient temperature of the device out of the tolerance ranges.
Defective internal temperature probe or any other technical anomaly.
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Note:
Ensure that you are operating the ventilator within the proper temperature range (refer to
Appendix
”).
Put the device in a warmer environment (if the ambient temperature is too low) or in a cooler environment (if the ambient temperature is too high). For example, ensure the ventilator is not in direct sunlight or next to an air conditioning vent.
WARNING:
In case of operation in a high ambient temperature, handle the ventilator with care; some portions of the device may have high surface temperatures.
WARNING:
In the case of high ambient temperatures, it may take a significant period of time to cool the internal temperature of the ventilator to the proper operating range. To avoid injury to the patient, ensure that the air inspired by the patient does not exceed 41 °C
(106 °F). If in doubt, replace the ventilator.
Replace the ventilator and call your customer service representative.
5-20 Clinician's Manual
Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s) Alarm Message or
Symptom
HIGH/LOW
BATTERY TEMP*
*IF PERSISTS
RESTART/SRVC
HIGH LEAKAGE
Battery temperature out of the tolerance ranges.
Defective internal temperature probe or any other technical anomaly inside the battery.
The LEAK estimated by the ventilator exceeds the
Max LEAK alarm threshold.
Caution:
Ensure that ventilator is being used according to the operating instructions
If the ambient temperature is too low, place the device in a warmer environment.
If the ambient temperature is too high, place the ventilator in a cooler environment.
For example, ensure the ventilator is not in direct sunlight or next to an air conditioning vent. The temperature fault alarm does not interfere with the operation of the ventilator.
WARNING:
In case of operation in a high ambient temperature, handle the ventilator with care; some portions of the device may have high surface temperatures.
Restart ventilator to see if alarm clears. if the alarm message persists, please contact technical services.
Caution:
Do not attempt to charge a defective battery; such a battery cannot be charged.
Readjust mask to reduce leakage or
Increase the alarm settings.
Clinician's Manual 5-21
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s) Alarm Message or
Symptom
HIGH VTE
HIGH VTI
Note:
Adjustment of the Max VTE level too low.
Inappropriate patient circuit.
Exhalation flow sensor not calibrated properly.
Defective exhalation flow sensor.
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Modify the Max VTE level.
Replace the patient circuit.
Ensure there is not excessive airflow near the exhalation block (such as a fan).
Calibrate the exhalation flow sensor (see section
, “
Calibrating the Exhalation Flow Sensor
).
Replace the exhalation block and calibrate the exhalation flow sensor (see section
). Call your customer service rep-
resentative.
Note:
Adjustment of the Max VTI level too low (for PSV,
CPAP, P A/C, P SIMV and V SIMV modes).
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Modify the Max VTI level.
Note:
Adjustment of the pressure level too high for the volume required (for PSV, CPAP, P A/C, P SIMV and
V SIMV modes).
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Modify the pressure level.
A leak in the patient circuit causing increased bias flow.
Inappropriate patient circuit.
Check and properly connect the patient circuit.
Replace the patient circuit.
Defective flow sensor or internal leak in the machine.
Have a qualified technician replace the defective component(s) and call your customer service representative.
5-22 Clinician's Manual
Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s) Alarm Message or
Symptom
HIGH PRESSURE
HIGH RATE
INSP FLOW
RESTART/SRVC
INTENTIONAL
VENT STOP
KEYPAD FAULT
RESTART/SRVC
LOW BATTERY
Note:
Adjustment of Max PIP too low (only for V A/C and
V SIMV modes).
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Increase the Max PIP threshold.
Airway obstruction.
Proximal pressure tube or patient circuit obstructed.
Check patient’s trachea and clear the obstruction. If the filter is obstructed, replace the filter.
Clean the proximal pressure tube or the patient circuit or replace them.
Coughing or other high-flow exhalation efforts.
Treat patient’s cough.
Pause the audible alarm, if necessary.
Patient inspiratory resistance or compliance changes.
Have physician determine if ventilator settings are appropriate for the patient.
Defective internal circuits of the machine or pressure sensor.
Replace the ventilator and call your customer service representative.
Adjustment of the Max Rtot level too low.
Adjustment of the I Sens level too low.
Readjust Max Rtot.
Adjust I Sens according to the patient.
Patient hyperventilating.
Defective inspiratory flow sensor.
Pause the audible alarm and call for a medical team if the symptoms persist.
Check for auto-cycling and adjust inspiratory sensitivity, manage leaks or drain condensation from patient circuit.
Have a qualified technician replace the defective component(s) and call your customer service representative.
Inspiratory flow is constant (
1 lpm) with normal turbine temperature and speed conditions.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
The user / caregiver has stopped ventilation using the VENTILATION ON/OFF key. Ventilation is in stand-by.
Check that the ventilation was switched off on purpose.
This alarm can be deactivated. See Chapter
Changing the Setup Menu Parameters
Pressing a key for more than 45 seconds.
A key on the keyboard is stuck.
Press and release keys in the normal, prescribed manner.
Do not press keys for 45 seconds or more.
If unsuccessful in releasing the stuck key(s), restart ventilator to see if alarm clears. If not, replace the device and call your customer service representative if the situation persists.
Internal battery capacity is less than 30 min. (or 8%) – battery operation overextended.
Immediately connect the ventilator to an AC power outlet, or connect it to an external DC power source.
Reminder: the internal battery can be charged only when the ventilator is connected to an AC power supply.
Clinician's Manual 5-23
Alarms and Troubleshooting
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event Corrective Action(s) Alarm Message or
Symptom
LOW FiO
2
LOW VTE
LOW VTI
Note:
The level of oxygen being delivered to the patient is below the Min FiO
2
limit set.
Patient circuit obstructed.
Always consult the clinician before changing
PEEP, FiO
2
, pressure, volume or Rate settings.
Check the level of oxygen corresponds to the patient’s prescription or
Decrease the FiO
2
alarm threshold.
Clean, unblock, and/or properly connect the patient circuit.
Leak in the patient circuit.
Check and properly connect the patient circuit connections.
May be caused by increased resistance across exhalation filter (such as excessive moisture).
Exhalation block missing or disconnected.
Restore or connect the exhalation block (see section
,
” on page
). If the exhalation block has
been removed or replaced, calibrate the exhalation flow sensor (see section
Calibrating the Exhalation Flow
). Call your customer service representative.
Adjustment of a Min VTE threshold when the patient circuit is in a single-limb configuration.
Set the Min VTE alarm limit to OFF.
WARNING:
If exhaled tidal volume monitoring is required, use the double-limb circuit.
Inappropriate patient circuit.
Replace the patient circuit with an appropriate one.
Exhalation flow sensor not properly calibrated.
Defective exhalation flow sensor.
Calibrate the exhalation flow sensor (see section
, “
Calibrating the Exhalation Flow Sensor
).
Replace the defective component(s) and calibrate the exhalation flow sensor (see section
). Call your customer service representative.
Modify the Min VTE level.
Adjustment of the Min VTE level too high.
Adjustment of the Min VTI level too high (for PSV,
CPAP, P A/C, P SIMV and V SIMV modes).
Adjustment of the pressure level not enough to reach the volume required (for PSV, CPAP, P A/C,
P SIMV and V SIMV modes).
Modify the Min VTI level.
Modify the pressure level according to the physician’s prescription.
Patient circuit obstructed or disconnected.
Inappropriate patient circuit.
Clean, unblock, and/or reconnect the patient circuit.
Replace the patient circuit.
Defective flow sensor or internal leak in the machine.
Check patient, replace the device and call your technician or customer service representative.
5-24 Clinician's Manual
Troubleshooting
Alarm Message or
Symptom
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event
NO PROXIMAL LINE2 The proximal pressure line is disconnected.
Adjustment of Min PIP too high.
Corrective Action(s)
Connect proximal pressure line.
Decrease the Min PIP threshold.
PATIENT
DISCONNECTION
Leak or loose connection in the patient circuit.
Circuit disconnection from patient or ventilator.
Check the patient circuit connections to the ventilator; examine all connections for leakage and tightness.
Replace the patient circuit if necessary.
*IF PERSISTS
RESTART/SRVC
Inspiratory flow exceeds 130 LPM.
Check Min PIP alarm setting.
Adjust Apnea alarm setting.
Replace the patient circuit.
Inappropriate patient circuit.
Defective internal circuits of the machine or pressure sensor.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component(s) or call your customer service representative.
OCCLUSION
CHECK CIRCUIT
Patient circuit obstructed.
Clean, unblock, and/or properly connect the patient circuit.
*IF PERSISTS
RESTART/SRVC
OCCLUSION
CHECK CIRCUIT
POWER FAULT
RESTART/SRVC
REMOVE VALVE OR
CHANGE PRES
REMOVE VALVE
CPAP MODE
A non-vented configuration is being used or the built-in leak in the mask or in the circuit may be obstructed or insufficient for the settings. Note that a high respiratory rate or backup rate may not sufficiently flush out CO
2 in some vented pediatric masks.
Replace the non-vented circuit with a vented one. Clean, unblock the mask or the circuit of the vented system or switch to a vented system with a larger leak configuration. Try to reduce patient’s backup rate if possible.
Internal problem in the electrical power supply.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
POWER SUPPLY LOSS
(without message)
PRES SENS FLT1
RESTART/SRVC
PROX SENS FLT2
RESTART/SRVC
Electrical power supply cut off by the main switch when ventilation is in progress.
The internal battery that supplies the ventilator is entirely discharged.
Press the I/O switch to restore electrical power to the ventilator and allow ventilation to continue.
To stop ventilation, press the VENTILATION ON/OFF key for three seconds, then release it. Press the VENTILATION
ON/OFF key again to confirm stop. (see Chapter
Immediately connect the ventilator to an AC power outlet or an external DC power source; otherwise, use an alternate device to ventilate the patient.
Defective internal pressure sensor.
Defective proximal pressure sensor or internal leak of the machine.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component(s) and call your customer service representative.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component(s) and call your customer service representative.
The ventilation settings are not compatible with the type of patient circuit used.
Remove exhalation valve to start ventilation with less than
5 mbar of difference between PEEP and Pi or
Increase the difference between PEEP and Pi to a minimum of 5 mbar.
The ventilation settings are not compatible with the type of patient circuit used.
Remove exhalation valve to start CPAP ventilation.
Clinician's Manual 5-25
Alarms and Troubleshooting
Alarm Message or
Symptom
Table 5-2. Alarms and Corrective Actions (Continued)
Possible Reason(s) For The Alarm Event
SOFTWARE VERSION
ERROR
Incorrect software version detected.
Corrective Action(s)
Call your customer service representative.
TURB OVERHEAT
RESTART/SRVC
Turbine overheated because of blockage during operation.
Ensure lateral and front openings are not obstructed.
Check air inlet filter.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
UNKNOWN BATTERY
Internal battery not recognized as a
Puritan Bennett™ product battery.
VALVE MISSING
CONNECT VALVE
VTI NOT REACHED
*IF PERSISTS
RESTART/SRVC
The ventilation settings are not compatible with the type of patient circuit used.
Defective inspiratory flow sensor or internal leak of the machine.
I time is not long enough to deliver set VT.
Call your customer service representative.
Connect exhalation valve.
Restart ventilator to see if alarm clears. If not, replace the defective device(s) and have a skilled technician check them.
Increase I time or decrease VT.
5.8.2
Additional Troubleshooting
provides other possible ventilator problems, causes, and corrective actions.
WARNING:
If the device is damaged, its external housing is not correctly closed, or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
WARNING:
If you cannot determine the cause of the problem, contact your equipment supplier. Do not use the ventilator until the problem has been corrected.
Note:
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.
5-26 Clinician's Manual
Troubleshooting
Table 5-3. Additional Troubleshooting and Corrective Actions
Conditions
No access to the waveforms
Display waveform set to OFF in Preferences menu.
The screen backlight never switches off during ventilation
Possible Causes
Backlight set to YES in Preferences menu.
Corrective Actions
Set Display waveform to YES in Preferences menu (see
Set Backlight to OFF in Preferences menu (see section
,
Alarm sound level too low or too high
Adjustment of the alarm sound level is incompatible with the patient’s environment.
Readjust sound level (see section
, “
Poor visibility of the displays
Unusual display on the screen
Contrast adjustment is incompatible with the luminosity of the environment.
Readjust contrast (see section
, “
Problem with the display unit.
Adjust contrast or call your customer service representative if the problem persists.
Ensure that the ventilator is not exposed to direct radiation from the sun.
The ventilator does not operate after pressing
I/O switch
No external power source and the internal battery is completely discharged.
Connect the ventilator to the AC power source.
Light noise
Whistling noise or vibrations
Excessive heat emitted
Condensation inside the device
Turbine noise.
Filter and/or turbine silencer deteriorated.
Valve membranes damaged.
Obstruction of main or secondary air inlets of the casings.
Liquid entered the device.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Replace the ventilator and call your customer service representative.
Remove obstructions from all blocked ventilator air inlets and outlets.
Replace the ventilator and call your customer service representative.
Clinician's Manual 5-27
Alarms and Troubleshooting
Page Left Intentionally Blank
5-28 Clinician's Manual
6 Installation and Assembly
WARNING:
Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter
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
.”
6.1
Installing the Ventilator
•
To install your Puritan Bennett™ 560 Ventilator:
Choose an area where air can circulate freely. Avoid proximity to loose fabrics, such as curtains, and direct exposure to sunlight.
•
Set the ventilator on a flat and stable surface so that its feet are all in contact with the surface. The ventilator may operate in any position, provided that the air inlets are not obstructed and the device cannot fall and possibly cause damage and/or personal injury.
WARNING:
The operator should connect the ventilator to an AC power source whenever available, for safer operation.
WARNING:
To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes
(main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains.
WARNING:
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.
6-1
6-2
Installation and Assembly
WARNING:
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.
WARNING:
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.
WARNING:
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.
WARNING:
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.
WARNING:
Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off.
WARNING:
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.
WARNING:
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.
WARNING:
The Puritan Bennett™ 560 Ventilator requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in
, “
.” In particular, the use of nearby mobile and portable communications equipment using radio frequencies, such as mobile telephones or other systems exceeding the levels set in the IEC / EN 60601-1-2 standard, may affect its operation. Refer to section
,
“
” on page
.
Clinician's Manual
Connecting to External AC Power
WARNING:
The ventilator must not use, nor be connected to, any anti-static or electrically conductive hoses, tubing, or conduits.
6.2
Connecting to External AC Power
Any of four power sources: AC power, 12 – 30 VDC power, Internal Battery power, or Auxiliary DC car adapter (cigarette lighter) can be used to power the ventilator. However, when AC power is available, the ventilator will automatically select AC power as its operating power source.
WARNING:
The power supply to which the ventilator is connected (both AC and DC) must comply with all current and applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear of the ventilator to ensure correct operation.
WARNING:
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.
WARNING:
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.
WARNING:
Do not leave power cables lying on the ground where they may pose a hazard.
Clinician's Manual 6-3
Installation and Assembly
To prevent accidental disconnection of the AC power cable, use the power cable holder (
, item 1) that is inserted into the notch (
, item 2) of the battery cover.
Figure 6-1. The Power Cable Holder
To secure the AC power cable:
1.
Insert the power cable holder (
, item 1) into the notch of the battery cover.
Figure 6-2. Inserting the Power Cable Holder Into the Notch
2.
Connect the female end of the ventilator’s AC power cable to the AC connector on the back of the ventilator.
6-4 Clinician's Manual
Figure 6-3. Power Cable Connected to the Ventilator
Connecting to External AC Power
3.
Connect the male end of the AC power cable to the AC power outlet.
•
•
The AC POWER
The indicator charged.
indicator on the top left corner of the ventilator illuminates.
flashes while the battery charges and then turns off when the battery is fully
See
If the AC power cable becomes disconnected or the AC power source fails, an “AC POWER DIS-
CONNECTION“ 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 (see
).
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).
Clinician's Manual 6-5
Installation and Assembly
Figure 6-4. Power Indicators
6-6
To disconnect the AC power cable:
1.
Disconnect the AC power cable from the AC power outlet.
2.
Disconnect the AC power cable from the ventilator’s AC connector at the rear of the device.
3.
Grasp the AC power cable at the level of the power cable holder and turn the cable clockwise while lifting it upwards and out of the holder.
6.3
Connecting to an External DC Power Source
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.
WARNING:
When using a car auxiliary adapter (cigarette lighter) ensure the car has been started prior to plugging in the ventilator’s DC adapter.
Note:
An alternative means of ventilation should always be available, particularly when the patient is in transit or away from wall power.
Note:
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.
Clinician's Manual
Connecting to an External DC Power Source
Note:
When AC power is not available use an external DC power prior to using internal battery power.
To connect the ventilator to an external power source, do the following:
1.
Ensure the car’s engine is started prior to connecting the ventilator.
2.
Connect the DC power cable into the ventilator.
3.
Connect the DC power cable into the car auxiliary adapter.
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 (
, item 1) that connects to the ventilator’s rear panel
DC power input connector (
, item 2). The DC power cable is optional; see Appendix
,” for more information. It is possible to use the DC auxiliary port (cigarette lighter) in a car as a power source as well.
Figure 6-5. Connecting the Ventilator to an External DC Power Source
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.
To connect the DC power cable to the ventilator:
1.
Line up the red marker dot on the ventilator’s DC power connector with the marker on the DC power cable (
Clinician's Manual 6-7
Installation and Assembly
Figure 6-6. Connecting the DC Power Cable to the Ventilator
6-8
1 Align the red markers
(dots or lines) before connecting the cable.
3 Disconnect the cable by sliding the locking ring back and pulling the plug away from ventilator
2 Push in to connect the
DC power cable
2.
Push the DC power cable onto the ventilator’s DC power connector (
, item 2).
•
•
You will hear a locking “click”.
The DC POWER indicator on the top left corner of the ventilator illuminates (see
To disconnect the DC power cable from the ventilator, slide the locking ring
(
, 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.
6.4
Patient Circuit
WARNING:
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.
Clinician's Manual
Patient Circuit
WARNING:
For pediatric use, ensure that the patient circuit type fits, and, in all respects, is suitable for use with
a child. Use a pediatric circuit for patients that weigh under 53 lb. (23 kg). See
for a list of recommended patient circuits.
WARNING:
If exhaled tidal volume measurements are required to ensure correct patient ventilation, a doublelimb 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 suffocation.
WARNING:
The patient circuit should always be positioned to avoid hindering the patient's movements, to prevent accidental disconnection or leakage, and to minimize the risk of patient strangulation.
WARNING:
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.
WARNING:
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
WARNING:
After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.
WARNING:
To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this manual; refer to Chapter
.” The total specified length of the patient circuit tubing as measured from the
ventilator outlet to the ventilator inlet is 1.1 meters (3.6 feet) to 2.0 meters (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.
Clinician's Manual 6-9
Installation and Assembly
WARNING:
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.
WARNING:
Users must always possess an additional breathing circuit and exhalation valve while using the
Puritan Bennett™ 560 Ventilator.
6.4.1
Choosing the Patient Circuit Type
Single-limb circuits are used with breathing modes where spirometry measurements are not required, and double-limb circuits are used with breathing modes where spirometry is required.
Be sure to choose the appropriate circuit in the menu preferences; in particular, ensure that Pedi-
atric Circuit Yes/No is set to YES when using a pediatric circuit (see Appendix
For information regarding validated circuits, visit the SolvIT
SM
Center Knowledge Base by clicking the link at http://www.covidien.com/rms/sales-support/ or contact your customer representative.
6.4.2
Installing the Patient Circuit
The patient circuit is mounted depending on the setup of the circuit used and the accessories used.
The following procedures describe the installation of the patient circuit with a humidifier. To add other accessories, see the installation instructions for the specific accessories used.
To connect a single-limb circuit with an exhalation valve:
See
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.
6-10 Clinician's Manual
Patient Circuit
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).
Figure 6-7. Single-Limb Patient Circuit With Exhalation Valve
Note:
Although shown here, the humidifier (item 3), water trap (item 4), and tubes upstream of the single-limb patient circuit are not included with the ventilator. Contact your supplier for more information.
To connect a double-limb circuit:
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.
Clinician's Manual 6-11
Installation and Assembly
3.
Attach one end of the short circuit tubing (item 4) to the filter (item 1).
4.
Attach the other end of the circuit tubing to the inlet port of the humidifier (item 2).
5.
Place a water trap (item 3) between the outlet port of the humidifier and the patient wye (item 5) on the double-limb circuit.
6.
Place a second water trap (item 3) between the patient wye (item 5) and the inlet port of exhalation bacteria filter (item 12).
7.
Connect the exhalation bacterial filter (item 12) between the FROM PATIENT and the exhalation limb of the patient circuit.
inlet port (item 10)
8.
Connect one end of the small proximal pressure tubing (item 6) to the double-limb patient wye circuit connection (item 5) and the other end on the ventilator patient pressure port (item 13).
9.
Place the exhalation valve assembly (item 9) on the exhaust port.
10.
Connect the tubing (item 8) from the exhalation valve assembly to the exhalation valve port (item 13) of the ventilator.
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.
Figure 6-8. Double-Limb Patient Circuit
6-12 Clinician's Manual
Patient Circuit
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.
Figure 6-9. Close-up of Exhalation Valve Tube and Proximal Pressure Tube
1
2
Inhalation port
Exhalation valve tube
3 Proximal pressure tube
shows details of the connections of the proximal pressure tube (
and the exhalation valve tube (
, item 8).
To connect a single-limb circuit without an exhalation valve (NIV only):
1.
Inspect the components of the patient circuit for any signs of damage, such as cracks (which might cause leakage). Do not use damaged components to assemble the patient circuit.
2.
Install the bacteria filter (item 1) on the TO PATIENT outlet port, as shown.
3.
Attach one end of the short circuit tubing (item 4) to the filter (item 1).
4.
Attach the other end of the circuit tubing (item 4) to the inlet port of the humidifier (item 2).
5.
Place a water trap (item 3) between the outlet port of the humidifier and the patient end.
6.
Place a mouthpiece or vented (NIV) interface to the end of the patient circuit (item 5).
Clinician's Manual 6-13
Installation and Assembly
Figure 6-10. Single-limb Patient Circuit Without Exhalation Valve
6-14
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 mouthpiece, 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.
WARNING:
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.
WARNING:
Resistance of the exhalation valve and accessories (water traps, filters, HMEs, etc.) must be as low as possible.
Clinician's Manual
Filters
WARNING:
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.
WARNING:
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.
WARNING:
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
,
”). This is particularly important when the ventilator is installed on a
wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
•
The ventilator features two filter types: air inlet filter
• bacteria filter
Air Inlet Filter
Consisting of foam and fine particle filter media and located at the rear of the ventilator, this filters the air as it enters the ventilator.
Clinician's Manual 6-15
Installation and Assembly
Figure 6-11. Air Inlet Filter
6-16
WARNING:
The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.
WARNING:
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
) 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). See
, item 1.
•
Connected to the FROM PATIENT port:
This filter protects the internal exhalation flow sensor from the gases exhaled by the patient. See
, item 10.
Clinician's Manual
Humidifier
Figure 6-12. Bacteria Filter
See the manufacturer’s instructions for more information about the use and maintenance of the bacteria filter(s).
6.6
Humidifier
) adds moisture (water vapor) and warms the gas in the patient circuit.
It is inserted into the patient circuit between the main outlet and the patient (see
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 minimize drying of the patient’s airways and subsequent irritation and discomfort, must be used.
WARNING:
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.
WARNING:
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.
WARNING:
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.
Clinician's Manual 6-17
Installation and Assembly
Figure 6-13. Humidifier
6-18
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.
See the humidification device’s instruction for information on operating, cleaning, and sterilizing the humidifier.
6.7
Exhalation Block
WARNING:
The exhalation block is intended for single use by a single patient. It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically (refer to section
, “
). The exhalation block should be changed every 4 months and cannot be reused with any other patient.
WARNING:
Ensure that the exhalation block is completely dried after cleaning and prior to use.
The exhalation block can be easily removed from the device for inspection, cleaning, and replacement. No special tools are required. It is held in place by a single captive screw located on the bottom of the device.
To remove the exhalation block:
See
1.
Ensure the ventilator is turned off.
2.
Loosen the captive screw located on the bottom of the ventilator that secures the exhalation block
, item 1). Grasp the exhalation port and slide the exhalation block to the left to remove it
from its slot (
, item 2).
Clinician's Manual
Oxygen
Figure 6-14. Removing the Exhalation Block
3.
After removal, the exhalation block can either be cleaned or, if required, replaced with a new one. For information on cleaning, see section
To install either a cleaned or a new exhalation block:
1.
Slide the exhalation block into its slot.
2.
Tighten the captive screw to secure the exhalation block in place.
3.
Recalibrate the exhalation flow sensor. See section
Calibrating the Exhalation Flow Sensor
page
.
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
Calibrating the Exhalation Flow Sensor
” on page
6.8
Oxygen
WARNING:
The ventilator must not be used with flammable anesthetic substances.
6.8.1
Administering Oxygen
WARNING:
Oxygen therapy for patients with respiratory failure is a common and effective medical prescription. However, be aware that inappropriate oxygen use may potentially lead to serious complications, including, but not limited to, patient injury.
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
Clinician's Manual 6-19
Installation and Assembly 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. (See section
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.
WARNING:
Ensure that the oxygen supply pressure to the machine never exceeds 7 psi (50 kPa) or a flow of
15 lpm. Refer to
for volume and sensitivity tolerances.
WARNING:
The Puritan Bennett™ 560 Ventilatorcan be used with an optional oxygen analyzer with minimum and maximum concentration alarms. Always measure the delivered oxygen with a calibrated oxygen analyzer (FiO
2
kit) that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
6.8.2
Connecting the Oxygen Supply
WARNING:
Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical-grade oxygen.
WARNING:
The hose connecting the ventilator to the oxygen source must be designed exclusively for use with medical-grade oxygen. Under no circumstances should the oxygen hose be modified by the user.
In addition, the hose must be installed without the use of lubricants.
, item 1) for an external low pressure oxygen source is available at the
rear of the ventilator. It is essential that you also use the special coupler (item 2) supplied with the ventilator to attach the external low pressure oxygen source to the connector. The connector is also fitted with a non-return airtight valve system. The non-return airtight valve system includes a stud (item 3) and a locking tab (item 4).
6-20 Clinician's Manual
Figure 6-15. Rear Panel Oxygen Connector
Oxygen
WARNING:
Before connecting the oxygen supply, ensure that the stud on the oxygen connector (
item 3) is protruding outwards.
WARNING:
, item 2) before use to ensure it has its black O-ring
attached and in good condition. Do not use an oxygen coupler with a missing, damaged, or worn
O-ring.
To connect the oxygen supply system to the ventilator:
1.
Inspect the oxygen supply’s connector (
, item 1) to ensure that connector’s black O-ring
(item 2) is not missing.
2.
Push the oxygen supply’s oxygen connector (item 1) into the ventilator’s oxygen connector (
•
• the ventilator’s oxygen connector’s locking stud (item 4) retracts.
the ventilator’s oxygen connector’s locking tab (item 5) is released, ensuring that the oxygen connection is locked and secured in place.
Clinician's Manual 6-21
Installation and Assembly
Figure 6-16. Connecting the Oxygen Supply System
To disconnect the oxygen supply system from the ventilator:
Note:
Ensure the oxygen source is turned off prior to placing the ventilator in Standby or turning off the ventilator.
Stop the oxygen flow from the oxygen supply.
1.
2.
Press the locking tab of the ventilator’s oxygen connector, as shown in
, to unlock the oxygen connection.
Figure 6-17. Disconnecting the Oxygen Supply System
6-22
3.
Disconnect the oxygen supply’s oxygen connector by pulling it towards you.
Clinician's Manual
Oxygen
The ventilator’s oxygen connector’s locking stud (
, item 4) will then extend outwards,
which is required before the oxygen connector can be reconnected.
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.
WARNING:
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.
WARNING:
To prevent any interference with the internal sensors of the ventilator, do not install a humidifier upstream of the ventilator.
6.8.3
Connecting the FiO
2
sensor
When administering oxygen it is recommended to use a FiO
2
oxygen sensor that can be connected to the front of the apparatus by means of a FiO
2
measurement kit.
To install the FiO
2
sensor:
Figure 6-18. Connecting the FiO
2
sensor
1.
Remove the sensor from the airtight packaging.
2.
Install the FiO
2
connector to the FiO
2
socket on the ventilator (item 1)
3.
Connect the FiO
2
sensor (item 2) onto Ø15mm adapter (item 3).
Clinician's Manual 6-23
Installation and Assembly
4.
Install the adapter on the TO PATIENT outlet port, as shown.
Fit the patient circuit after the adapter.
Note:
When using a new sensor, allow its temperature to become stable for about 20 minutes in ambient air before installing it, calibrating it and starting ventilation.
6.9
Mounting the Ventilator on a Wheelchair
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.
WARNING:
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.
WARNING:
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.
WARNING:
If exhaled tidal volume measurements are required to ensure correct patient ventilation a doublelimb 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 suffocation.
WARNING:
To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the ventilator.
, “
List of Consumables and Accessories
.”
WARNING:
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 Dual Bag accessory consists of a carrying bag that allows the Puritan Bennett™ 560 Ventilator-
to be both mounted onto a wheelchair or carried as a backpack (see
See the Dual Bag’s instructions for further information.
6-24 Clinician's Manual
Mounting the Ventilator on the Utility Cart
Figure 6-19. Using the Dual Bag Accessory
6.10
Mounting the Ventilator on the Utility Cart
Match the mounting holes (item 1) on the bottom of the Puritan Bennett™ 560 Ventilator to the mounting studs (item 2) on the top of the utility cart platform.
Clinician's Manual 6-25
Installation and Assembly
6-26
6.11
Connecting the Nurse Call Cable
Connect the Nurse Call cable (
, item 1) to the Nurse Call Monitor Connector (item 2).
Figure 6-20. Connecting the Nurse Call Cable
Clinician's Manual
Connecting the Nurse Call Cable
WARNING:
Before using the Nurse Call system, ensure that its connections are secure and it operates properly.
For more information, contact Covidien.
WARNING:
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.
WARNING:
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.
Note:
The PB560 has been designed to accommodate connectivity with Nurse Call/monitoring systems. Because it is not possible to anticipate every configuration of hardware and software associated with Nurse Call/ monitoring system, it is the user’s responsibility to confirm proper functionality of the system when used in conjunction with the PB560. Verification of alarms, alerts, and patient data transmissions is required. If the system performance is not as expected, contact Technical Support for assistance troubleshooting the setup. Do not use the PB560 ventilator with a Nurse Call/monitoring system until the functionality of the ventilator/system combination has been confirmed.
Note:
Complete a self-test after the cable has been installed and at regular intervals to ensure the system is operating as intended. A self-test consists of inducing an alarm and confirming the Nurse Call/monitoring system unit emits an audio alarm, and also confirming the audio alarm ceases once the alarm in the ventilator has been reset.
•
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 alarm delay, once generated from the ventilator, to the nurse call output/input cable connectors is less than 100 ms.
The remote alarm port is an 8-pin female connector; allowable current is 100mA at 24VDC (max).
•
Clinician's Manual 6-27
Installation and Assembly
Page Left Intentionally Blank
6-28 Clinician's Manual
7 Operating Procedures
7.1
Turning on the Ventilator
WARNING:
Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter
WARNING:
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 stabilize in its operating environment for at least two (2) hours prior to use.
WARNING:
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.
WARNING:
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.
WARNING:
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.
WARNING:
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.
7-1
7-2
Operating Procedures
WARNING:
Users must always possess an additional breathing circuit and exhalation valve while using the
Puritan Bennett™ 560 Ventilator.
WARNING:
Verify the functionality of the alarm conditions before connecting the patient to the ventilator.
, “
WARNING:
Before starting ventilation, always verify that all settings are properly set in accordance with the required prescription.
WARNING:
If the ventilator fails the alarm tests or if you cannot complete the tests, refer to Chapter
“
” or call your equipment supplier or Covidien.
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.
•
To turn the ventilator on:
Set the I/O switch (a covered, rocker-type switch located at the rear of the ventilator) to the I position,
below.
Figure 7-1. Turning on the Ventilator
Clinician's Manual
Turning on the Ventilator
•
•
•
•
•
•
The following events occur:
The ventilator is powered on.
A Power On Self Test (POST) is carried out (when plugged in to an AC power source).
The front panel indicators flash (except for the indicator showing the type of power supply in use, which remains lit).
The audible alarms briefly sound.
The display’s backlight turns on.
The PURITAN BENNETT™ logo is displayed momentarily.
•
•
The blue VENT STDBY indicator to the right of the VENTILATION ON/OFF key illuminates, indicating the device is in standby mode.
A Welcome Menu screen is displayed for about five (5) seconds, which includes the machine counter and the patient counter, as shown in
Figure 7-2. Welcome Menu Screen
Note:
If the ventilator had been previously stopped by use of the I/O switch while ventilation was in progress, the ventilator starts directly in ventilation mode and does not show the Welcome Menu screen.
Note:
The Alarm, Technical Fault, and Event logs are stored in non-volatile memory on the Main CPU PCB, ensuring that the information is retained when the ventilator is powered off and during power loss conditions.
To skip the Welcome Menu:
Press VENTILATION ON/OFF to start ventilation immediately.
The Ventilation menu is then displayed.
Clinician's Manual 7-3
Operating Procedures
Figure 7-3. Ventilation Menu Parameters
7-4
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.
7.2
Setup Menu Parameters
7.2.1
Accessing Setup Configuration
Note:
The Locking Key prevents access to the Setup menu (see section
” on page
and section
Note:
The Setup menu cannot be accessed if the ventilator had been powered off, without first placing the device into standby.
Check the ventilator’s I/O switch is set to OFF (O) position.
1.
2.
Press and hold the ALARM CONTROL key while switching the I/O switch to the ON (I). Hold the
key until the Setup menu appears (approximately three seconds). See
Clinician's Manual
Figure 7-4. Setup Menu
Setup Menu Parameters
3.
7.2.2
Changing the Setup Menu Parameters
To change the Setup Menu settings:
1.
Press UP or DOWN to position the cursor beside the parameter to be modified.
2.
Press ENTER
•
•
.
The cursor changes to: .
The selected parameter value flashes.
3.
Press UP or DOWN to modify the value of the selected parameter.
4.
Press ENTER to confirm the newly selected value.
Note:
If you do not confirm a change by pressing ENTER restores the setup field’s previous value.
Note:
before seven (7) seconds elapse, the ventilator
When a parameter contains several setup fields (such as Date and Time) press ENTER one field to the next.
to move from
Clinician's Manual 7-5
7-6
Operating Procedures
•
•
•
•
•
•
•
•
•
•
•
The parameters in this menu are:
Machine Hours
Language
Date
Time
Intentional Vent Stop
Pressure Unit
Alarm Tone
Patient Hours
Restore Defaults
Maintenance
Next
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:
English (US)
English (UK)
German
Table 7-1. Languages
Finnish
Russian
Portuguese
Danish
Chinese
Polish
Norwegian
Turkish Dutch
Swedish Korean
Japanese
Italian
Greek
French
Spanish
–
–
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.
Clinician's Manual
Setup Menu Parameters
Intentional Vent Stop Alarm
Intentional Ventilation Stop Alarm is an alarm to warn that ventilation has been switched off by the user / caregiver and the ventilator is in stand-by.
To set the Intentional Vent Stop Alarm:
1.
Use the UP tion.
or DOWN arrows to place the cursor at the “Intentional Vent Stop” alarm posi-
2.
Press ENTER .
3.
Press UP or DOWN to set the message to “YES”.
Press ENTER
Pressure Unit
to confirm the selection.
The unit of pressure can be set here. It can be displayed as mbar, cmH
2
O or hPa.
Alarm Tone
Alarm tone options include Original (louder) or Compliant (softer). The default setting is Compliant. The audible sound of Compliant is softer than the Original tone, and meets the requirements of alarm standard 60601-1-8. Original refers to the alarm tone that was shipped with the ventilator from initial product launch until the LX010101/LX010023 software update.
To change the alarm tone:
1.
Use the UP arrows to place the cursor on Alarm Tone.
2.
Press ENTER .
3.
Use the UP arrows to select Compliant or Original.
4.
Press ENTER to confirm the selection.
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.
To reset the Patient Hours counter to zero:
Press DOWN to place the cursor at the “Patient Hours“ line, as shown in the following graphic:
1.
Clinician's Manual 7-7
Operating Procedures
Figure 7-5. Resetting Patient Hours to Zero (1)
2.
Press ENTER .
•
The cursor is placed on the “Reset Hours” line: OFF“.
3.
Press ENTER
•
“OFF“ flashes.
.
4.
Press UP ic:
or DOWN to change the “OFF” message to “YES“, as shown in the following graph-
Figure 7-6. Resetting Patient Hours to Zero (2)
7-8
5.
•
Press ENTER .
“YES“ is displayed continuously.
•
•
A long “beep“ sounds.
The patient counter display indicates 00000h, as shown in the following graphic:
Clinician's Manual
Figure 7-7. Resetting Patient Hours to Zero (3)
Setup Menu Parameters
6.
•
Press UP or DOWN .
The display indicates “Reset Hours: OFF“, as shown in the following graphic:
Figure 7-8. Resetting Patient Hours to Zero (4)
Restore Defaults
This allows the user to reset all settings back to the original manufacturer defaults except for the
Language, Date, and Time.
To restore settings back to the manufacturer defaults:
1.
Press UP or DOWN
to position the cursor beside “Restore Defaults,” as shown in
Clinician's Manual 7-9
Operating Procedures
Figure 7-9. Restoring Default Settings (1)
2.
Press ENTER
3.
. “OFF” flashes.
to change “OFF” to “YES,” as shown in
Figure 7-10. Restoring Default Settings (2)
7-10
4.
Press ENTER to reset all settings back to the manufacturer defaults except for Language, Date,
and Time. “OFF” will reappear, as shown in
Clinician's Manual
Figure 7-11. Restoring Default Settings (3)
Setup Menu Parameters
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.
Next
This allows the user access to Setup 2 menu. For more information, see section
.
7.2.3
Entering Setup 2 Menu
1.
Press UP or to position the cursor beside NEXT.
2.
Press ENTER .
The Setup 2 menu is displayed.
Figure 7-12. Setup 2 Menu
Clinician's Manual 7-11
Operating Procedures
•
•
•
•
The parameters in this menu are:
Cycling mode
Relative pressure
E Sens Setting
Back
Cycling Mode
The cycling mode is used to set which calculated value (I:E or I/T) appears in the parameter zoom window when changing Insp Time or Rate settings. It is also used to set the monitored data value
(I:E or I/T) displayed in the monitored data window and graphics screen.
The two cycling modes represent the relationship between inspiration time to exhalation time as follows:
1.
I/T is inspiratory time (Ti) as a percentage of total breath cycle time (Ti + Te).
I/T (%) = [Ti / (Ti+Te)] x 100
2.
I:E is the ratio of inspiratory time (Ti) to exhalation time (Te).
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.
Absolute and Relative Pressure
The relative pressure for the inspiratory pressure setting (P Control and P Support) in PSV, P A/C, and P SIMV, can be set to OFF or YES and allows the choice between setting the inspiratory pressure relative to PEEP or setting an absolute inspiratory pressure. The default value is absolute
(ABS).
If relative pressure is set to YES, the PEEP is added to the inspiratory pressure setting to determine the peak inspiratory pressure. If relative pressure is set to OFF, the inspiratory pressure setting will determine the peak inspiratory pressure regardless of the PEEP setting.
Relative pressure = YES: Inspiratory pressure setting + PEEP = Peak Inspiratory pressure
Relative pressure = OFF (ABS): Inspiratory pressure setting = Peak Inspiratory pressure
The symbol ABS for absolute or REL for relative will be displayed at the top of the screen as follows:
7-12 Clinician's Manual
Figure 7-13. Absolute and Relative Pressure
Setup Menu Parameters
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.
Figure 7-14. E Sens Settings
Clinician's Manual x Seconds y1 Inspiration y2 Exhalation
7-13
Operating Procedures
Back
Allows the user to return to the Setup menu.
7.2.4
Exiting the Setup Menu
To exit the Setup menu, you must cycle the ventilator’s power.
1.
Set the ventilator’s rear panel I/O switch to OFF (O). Wait 30 seconds.
2.
Set the ventilator’s I/O switch ON (I).
The ventilator will run through a Power On Self Test (POST) routine and then return to Standby mode.
7.3
Preferences Menu Parameters
The Preferences menu is only accessible if the Locking Key has not been enabled (refer to section
,
).
The Preferences menu is accessed from the Ventilation Parameters menu, when ventilation is either on or off.
WARNING:
Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
7.3.1
Preferences Menu
To display the Preferences menu:
1.
Press DOWN several times, or continue to press DOWN ences” line, as shown in the following graphic:
2.
Press ENTER . The Preferences menu is displayed.
, until the cursor is on the “Prefer-
7-14 Clinician's Manual
Figure 7-15. Selecting the Preferences Menu
Preferences Menu Parameters
Figure 7-16. Changing Settings in the Preferences Menu
To change the settings in the Preferences menu:
1.
Press UP to place the cursor on the parameter line to be modified.
2.
Press ENTER .
•
•
The cursor changes to the plus/minus symbol.
The parameter selected to be modified flashes, or for certain parameters featuring a bar graph, the indicator triangle under the bar graph becomes filled.
Refer to the following graphics.
Clinician's Manual 7-15
Operating Procedures
7-16
3 indicator triangle: filled 1
2
Cursor: plus/minus symbol
Parameter value: flashing
3.
to change the selected parameter’s value.
4.
•
Press ENTER to confirm the new parameter setting.
The new parameter setting is displayed.
•
The cursor returns to its initial form.
Note:
If a parameter change is not confirmed by pressing ENTER before seven (7) seconds elapse, the ventilator resets the parameter to its previous value.
•
The parameters in this menu are:
Backlight
•
•
•
•
•
•
•
•
Contrast
Alarm Volume
Key Sound
Apnea Alarm
Disconnection Alarm
Waveforms Display
Pediatric Circuit
Ventilation Report
•
To adjust the various Preferences menu parameters, or to view the Ventilation Report, refer to the instructions provided in this section.
To manually exit from the Preferences menu:
Press ENTER when the cursor is on the “Back to Ventilation“.
•
You will automatically exit from the Preferences menu when:
No keyboard action is detected before 15 seconds elapse, or
Clinician's Manual
Preferences Menu Parameters
•
A High Priority alarm is triggered.
7.3.2
Backlight
To set the Backlight:
1.
Select the Backlight parameter on the display.
2.
Set the backlight:
•
To set the backlight to standby, select OFF.
The effect of this setting is that if no keyboard action occurs before one minute elapses, the display’s backlight fades almost to off. The display will illuminate when the following occurs:
• Any one of the keys on the keyboard is pressed
• An alarm is triggered
•
To set the backlight to light continuously, select YES. This setting ensures that the display is continuously lit.
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.
Press ENTER to confirm the new Backlight setting.
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:
•
To increase the contrast, press UP right:
. This change can be observe as the cursor moves to the
The display contrast progressively increases.
Clinician's Manual 7-17
Operating Procedures
•
To decrease the contrast, press DOWN the left:
. This change can be observe as the cursor moves to
The display contrast progressively decreases.
3.
Press ENTER to confirm the new Contrast setting.
When ventilation is stopped, the contrast can also be changed directly from the currently displayed menu by pressing ALARM CONTROL continuously, while repeatedly pressing UP
or DOWN .
The default setting for Contrast is the medium setting (the middle of the bar graph).
7.3.4
Alarm Volume
WARNING:
The sound level of the alarms should be adjusted according to the installation environment and the size of the area monitored by the patient’s caregiver. Ensure that the alarm sound apertures at the front of the device are never obstructed.
To set the Alarm Volume:
1.
Select the Alarm Volume parameter on the display.
2.
Set the Alarm Volume level:
. This change can be observed as the cursor
•
To increase the sound level of alarms, press UP moves to the right:
•
The buzzer activates and increases in sound level as the setting increases.
To decrease the sound level of alarms, press DOWN cursor moves to the left:
. This change can be observed as the
7-18 Clinician's Manual
Preferences Menu Parameters
The buzzer activates and decreases in sound level as the setting decreases.
3.
Press ENTER to confirm the new Alarm Volume.
Current hospital standards require a minimum sound level of 55 dB(A) at a distance of 3 meters
(9.84 feet), which corresponds to the lowest possible volume setting. The alarm sound level range is described in section
.” If a high priority alarm is not paused within 60 seconds of activation, the sound level automatically raises to the maximum level, regardless of the original setting.
The default setting for Alarm Volume corresponds to a level of halfway between the minimum and maximum values.
7.3.5
Key Sound
This setting is used to select the sound emitted when pressing keys on the ventilator’s keyboard.
To set Key Sound:
1.
Select the Key Sound parameter on the display.
2.
Select one of the following four options:
•
•
OFF – No sound is emitted when a key is pressed
Key tone – A “clock” sound is emitted when a key is pressed
•
•
Accept tone – A “beep” sounds when ENTER is pressed to confirm a setting
All tones on – A “clock” sound is emitted when all keys are pressed and a beep sounds when
ENTER is pressed to confirm a setting
3.
Press ENTER to confirm the new Key Sound setting.
The default setting for Key Sound is Accept tone.
Note:
Whatever the selected Key Sound setting, pressing the VENTILATION ON/OFF key triggers a “beep” at ventilation start and a double “beep“ at ventilation stop.
7.3.6
Apnea Alarm
To set the Apnea Alarm:
1.
2.
Press ENTER .
arrow keys to place the cursor at the “Apnea Alarm” position.
Clinician's Manual 7-19
Operating Procedures
3.
to set the message to “YES”. Setting the key to “OFF” means the Apnea
Alarm will not sound when the ventilator is stopped.
4.
Press ENTER to confirm the selection.
WARNING:
The Apnea Alarm should be set to YES for ventilator dependent patients.
Figure 7-17. Setting the Apnea Alarm
7-20
Note:
This activates / deactivates the Apnea alarm but not the Apnea Time Setting. The Apnea Time Setting can be set in the Ventilation Menu.
7.3.7
Disconnection Alarm
To set Disconnection Alarm:
1.
arrow keys to place the cursor at the “Disconnection Alarm” position.
2.
Press ENTER .
3.
arrows to adjust the setting between 5 and 62 seconds.
4.
Press ENTER to confirm the selection.
Note:
Values set in the ventilation mode may supersede disconnection alarm values. Refer to Chapter
Clinician's Manual
Preferences Menu Parameters
7.3.8
Waveforms Display
To set Waveforms Display:
1.
Select the Waveforms Display parameter on the display.
2.
Select either:
•
•
YES – Displays pressure and flow waveforms as a function of time (refer to section
OFF – Results in no waveform display; hence, no waveform menu.
3.
Confirm the new Waveforms Display setting before seven (7) seconds elapse.
The default setting for Waveforms Display is OFF.
The waveform screen, on which the waveforms are displayed, is accessed using MENU from the Alarm Setting menu. This screen is available ONLY when ventilation is in progress.
7.3.9
Pediatric Circuit
To choose a pediatric circuit:
1.
2.
Press ENTER.
arrows to place the cursor at the “Pediatric Circuit” position.
3.
the device for an Adult circuit.
to set the message to “YES.” Setting the ventilator to “OFF” configures
4.
Press ENTER to confirm the selection.
Note:
The default setting is “OFF” (the ventilator is set for Adult use).
7.3.10
Ventilation Report
Accessing the Ventilation Report:
1.
arrows to place the cursor at the “Ventilation Report” position.
2.
Press ENTER .
Clinician's Manual 7-21
Operating Procedures
Figure 7-18. Accessing the Ventilation Report
7-22
Note:
The menu is displayed for five minutes then screen reverts to the Preferences Menu.
To exit the Ventilation report:
Press ENTER .
7.4
Setting the Ventilation Mode
The ventilation mode can be changed from the ventilation parameters menu or the alarm param-
eters menu, as long as the Locking Key is not enabled (refer to section
, and section
).
The procedure to change the ventilation mode depends on the ventilation status, as described in
and section
.
WARNING:
In the SIMV mode the use of a double limb circuit is recommended. The VTE Min setting should remain active in the event that pressure losses are present on the patient circuit downstream from the proximal pressure link. In such cases the “PATIENT DISCONNECTION” alarm would not be systematically activated in case of a disconnection of the circuit.
WARNING:
Most breaths are triggered by the patient. You should carefully modify the inspiration trigger threshold in order to avoid the risk of false triggering or “autotriggering” of the ventilator. For example, Level 0P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.
Clinician's Manual
7.4.1
Changing Modes While Ventilation is on Standby
To change ventilation modes while on standby:
1.
Figure 7-19. Changing Ventilation Modes While on Standby
Setting the Ventilation Mode
2.
Press ENTER .
•
•
The cursor changes to: .
The mode name flashes.
3.
until the required mode is displayed.
4.
•
Press ENTER to confirm the mode selected.
The cursor returns to normal.
•
The new mode is displayed with its ventilation parameters.
Note:
If the ventilation mode change is not confirmed by pressing ENTER before seven (7) seconds elapse, the ventilator restores the previous mode.
7.4.2
Changing Modes During Ventilation
WARNING:
When changing the mode during ventilation, significant transitions of pressure, flow or cycling rate might occur, depending on the difference between the modes. Before setting the new mode, first ensure that the settings between the different modes are compatible. This reduces the risk of discomfort and harm to the patient.
Clinician's Manual 7-23
Operating Procedures
Changing ventilation modes during ventilation:
1.
Figure 7-20. Changing Ventilation Modes During Ventilation (1)
2.
Press ENTER .
•
•
The cursor changes to: .
The mode name flashes.
3.
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).
7-24 Clinician's Manual
Figure 7-21. Changing Ventilation Modes During Ventilation (2)
Setting the Ventilation Mode
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.
Figure 7-22. Changing Ventilation Modes During Ventilation (3)
5.
Change the settings of the new mode, including alarms, if necessary.
6.
Press DOWN to place the cursor on the “Accept Mode: YES“ line.
7.
•
Press ENTER to confirm the mode change.
The new mode selected is displayed with its settings. It is applied at the beginning of the next exhalation phase if it occurs during inspiration or immediately if it occurs during exhalation.
It is not mandatory to change modes during ventilation (see steps 6 and 7, above). 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
(“current”) column of the table on the Alarm menu screen.
Clinician's Manual 7-25
Operating Procedures
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.
Figure 7-23. Changing Ventilation Modes During Ventilation (4)
7-26
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.
7.5
Setting Ventilation Parameters
Ventilation parameters can be changed as long as the Locking Key is not activated (refer to
” on page
).
WARNING:
In adult or pediatric use ensure that the adjusted tidal volume is compatible with the needs of the patient.
Ventilation is not interrupted by the adjustment of a value. It continues according to previous settings. The new settings are applied ONLY after they are confirmed and synchronized in the next breath cycle, except for the I Sens setting, which is applied immediately.
To modify a ventilation parameter:
1.
Clinician's Manual
Setting Ventilation Parameters
2.
Validate your intention to modify the parameters using the ENTER below.
•
•
•
button. Refer to the figure
The cursor changes to: . (item 1, below)
The parameter value flashes (item 2, below)
A zoom of the parameter value is displayed in the right-side of the window (item 3, below).
Figure 7-24. Modifying a Ventilation Parameter
3.
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 ventilator restores the parameter’s previous value.
before seven (7) seconds elapse, the
7.5.1
Links between Ventilation Parameters
The adjustment ranges of certain parameters are limited in order to remain compatible with the levels of other previously set parameters. For additional information on the interdependence between ventilation parameters, refer to Chapter
.”
The message “Setting limited by...“ is displayed and identifies the parameter(s) that is (are) blocking the setting.
Clinician's Manual 7-27
Operating Procedures
, item 1, shows that P Support cannot be set above 35 when PEEP is set to 20 and rel-
ative pressure is set to YES; this value is limited by PEEP because their sum cannot exceed 55 mbar.
Figure 7-25. Setting Links Between Ventilation Parameters
7-28
•
•
Two possibilities exist in this case:
Allow the PEEP setting to remain at 20, but the P Support cannot be increased.
Reduce PEEP so that the P Support setting can be set higher than 35 to ensure that their sum is no greater than 55.
7.5.2
Links between Ventilation and Alarm Parameters
Setting a ventilation parameter takes priority over an alarm threshold setting and leads to automatic readjustment of the alarm setting threshold so that the interdependence between the two remains unchanged.
Once the ventilator is in service at the patient’s home, you should use the Locking Key to block access to changing any settings (see section
, “
7.6
Setting Alarm Parameters
Alarm parameters can be changed from the Alarm menu, if the Locking Key is not enabled (refer
, “
).
Note:
Adjustable alarms should not be systematically canceled, they should be adjusted according to the needs and condition of the patient.
Note:
Default alarm setting preferences should be entered prior to using the ventilator.
Clinician's Manual
Setting Alarm Parameters
2.
3.
To modify an Alarm Parameter:
1.
Ensure that the Alarm menu is displayed, showing a list of alarm parameters and columns for the minimum, current, and maximum alarm parameter values (
).
•
•
•
The cursor changes to:
The parameter in the “Min“ column flashes (
A zoom of the min parameter is displayed on the right side of the screen
(
, item 3).
Figure 7-26. Modifying Alarm Parameters – Min Value
4.
to modify the value of the parameter.
5.
•
Press ENTER to confirm the value selected.
The new value for the “Min“ column is continuously displayed (
, item 1).
•
•
The value of the “Max“ column flashes (
, item 2).
A zoom of the Max parameter value is displayed on the right side of the window (
item 3).
Clinician's Manual 7-29
Operating Procedures
Figure 7-27. Modifying Alarm Parameters – Max Value
7-30
6.
to modify the value of the parameter.
7.
•
Press ENTER to confirm the value selected.
The new value is continuously displayed
•
The zoom disappears
•
The cursor returns to normal
An alarm is set to “OFF“ (the alarm will not be triggered) when its maximum setting limit (for the
Max value) or its minimum setting limit (for the Min value) is reached by successively or continu-
Note:
If a parameter change is not confirmed by pressing ENTER ventilator restores the parameter’s previous value.
before seven (7) seconds elapse, the
Blocking of an Alarm Threshold Linked to a Ventilation Parameter
Setting a ventilation parameter takes priority over an alarm threshold setting. Therefore, if a ventilation parameter is modified when linked to an alarm threshold, the alarm setting threshold is automatically adjusted so that the interdependences linking them are always maintained.
However, if the alarm setting threshold is modified, it cannot be changed beyond the limit of the interdependence with the ventilation parameter to which it is linked. When the alarm setting limit is reached, the message “Setting limited by...“ indicates the name of the linked ventilation parameter(s) that are limiting the parameter’s setting value.
•
Four possibilities exist in this case:
The alarm parameter remains set to “OFF“.
•
The alarm parameter setting is changed in relation to the value required at the start and the limits on the ventilation parameter(s) remain unchanged.
Clinician's Manual
USB Menu Parameters
•
The setting of the ventilation parameter(s) is changed to enable the alarm threshold to be set to the required value.
•
The alarm parameter is not set to OFF but the ventilation parameter change has no impact on the alarm setting.
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.
WARNING:
Adjustable alarms should not be systematically canceled; instead, they should be adjusted according to the needs and condition of the patient.
7.7
USB Menu Parameters
The USB menu is accessible even if the Locking Key has been enabled (refer to section
” on page
).
The USB menu is automatically displayed when the USB memory device is connected to the ventilator, when ventilation is either on or off.
Only one USB memory device shall be connected at any time, otherwise an error message will be displayed. The USB Menu is not accessible from the Setup Menu or Maintenance menu.
To access patent data via a PC, a dedicated software package, Puritan Bennett™ respiratory insight software, is available for Clinicians. Contact Covidien or your Puritan Bennett™ product representative for further information.
7.7.1
USB Memory Device Specifications
Characteristics
USB compatibility
Number of files
USB size
Table 7-2. USB Memory Device Specifications
Supported Formats
USB flash memory USB 2.0 or USB 1.1, 32 bit format
Maximum 999 (sector size: 512-2,048 bytes)
128 MB to 4GB (To guarantee accuracy of transfer time, at least 10% of the USB memory device capacity must be free).
Clinician's Manual 7-31
Operating Procedures
7.7.2
USB Menu
To access the USB menu when a USB memory device is connected:
Press the MENU key several times, until the USB Menu appears:
Figure 7-28. Selecting the USB Menu
7-32
•
•
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.
•
The adjustable parameters in this menu are:
Transfer continuously
Transfer trends
Erase key
7.7.3
Transfer Continuously
Up to 48 hours worth of data can be transferred from a ventilator to a USB memory device.
To record continuously, the USB memory device must be permanently connected to the ventilator and ventilation is active.
•
The following data will be recorded to the USB memory device:
Monitoring: pressure, inspired flow, exhaled flow and leak waveforms.
•
Trends: leaks, VTI, VTE, Rate, I:E, M. Vol, PIP, and PEEP measurements.
The data can be accessed by a doctor or service provider using the Puritan Bennett™ respiratory insight software.
Clinician's Manual
Figure 7-29. Selecting Transfer Continuously
USB Menu Parameters
To transfer continuous data from a ventilator to a USB memory device:
1.
arrow keys to place the cursor at the “Transfer Continuously” position.
2.
•
Press ENTER .
The cursor changes to the plus/minus symbol.
•
The parameter selected to be modified flashes.
3.
to change the selected parameter’s value.
4.
•
Press ENTER to confirm the new parameter setting.
The new parameter setting is displayed continuously.
•
The cursor is placed at the STOP position.
5.
To manually stop continuous transfer, press the ENTER key.
Note:
If a parameter change is not confirmed by pressing ENTER before seven (7) seconds elapse, the ventilator resets the parameter to its previous value.
Note:
All ventilator menus remain accessible during transfer time.
Note:
The message “TRANSFER IN PROGRESS... REMAINING TIME” is displayed during the transfer time.
Note:
Other functions of the USB memory device are not available during continuous recording,
Clinician's Manual 7-33
Operating Procedures
Note:
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 section
, “
Erase Data from the USB Memory Device
Note:
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.
7.7.4
Transfer Trends
Up to one year’s worth of trend data can be transferred from a ventilator to a USB memory device.
Ventilation trends such as leaks, VTI, VTE, Rate, I:E, M. Vol, PIP, and PEEP measurements can be transferred from the ventilator to a USB memory device.
The data can be accessed by a doctor or service provider using the Puritan Bennett™ respiratory insight software.
Figure 7-30. Selecting Transfer Trends
7-34
To transfer trend data from a ventilator to a USB memory device:
1.
arrow keys to place the cursor at the “Transfer Trends” position.
2.
•
Press ENTER .
The cursor changes to the plus/minus symbol.
•
The parameter selected to be modified flashes.
3.
to change the selected parameter’s value.
Clinician's Manual
USB Menu Parameters
4.
•
Press ENTER to confirm the new parameter setting.
The new parameter setting is displayed continuously.
•
The cursor is placed at the STOP position.
5.
To manually stop trend transfer, press ENTER .
Note:
If a parameter change is not confirmed by pressing ENTER ventilator resets the parameter to its previous value.
before seven (7) seconds elapse, the
Table 7-3. Time taken to transfer trends data from the ventilator to a USB memory device
Amount of trends data
(in months)
3 months
Transfer time from ventilator to USB memory device
Approximately 2 minutes
6 months
9 months
Approximately 4 minutes
Approximately 6 minutes
12 months Approximately 8 minutes
Note:
The message “TRANSFER IN PROGRESS... REMAINING TIME” is displayed during the transfer time.
Note:
Other USB memory device functions are available during transfer of trends.
Note:
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 section
Erase Data from the USB Memory Device
.”)
Note:
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.
7.7.5
Erase Data from the USB Memory Device
To erase data from the USB memory device:
1.
arrow keys to place the cursor at the “Erase key” position.
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Operating Procedures
2.
•
Press ENTER .
The cursor changes to the plus/minus symbol.
•
The parameter selected to be modified flashes.
3.
to change the selected parameter’s value.
4.
•
Press ENTER to confirm the new parameter setting.
The new parameter setting is displayed continuously.
•
The cursor is placed at the STOP position.
Figure 7-31. Erasing Data from the USB Memory Device
7-36
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.
Note:
The deletion time of a full USB memory device is less than one minute.
Note:
Other USB memory device functions are not available during deletion.
Note:
Once deletion of the USB memory device has been started, it cannot be paused, stopped or canceled.
Note:
All ventilator menus remain accessible during deletion.
Clinician's Manual
Locking the Control Panel
Note:
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 erase process. If the problem persists contact your technical service.
7.8
Locking the Control Panel
•
When the machine is in service at a patient’s home, it is strongly recommended that you prevent accidental or unauthorized ventilator adjustments from occurring by enabling the Locking Key.
The Locking Key is a software function that prohibits access to the ventilation and alarm parameter settings and changes to the ventilation mode.
To enable the Locking Key:
•
Simultaneously press the UP and the DOWN keys for at least six (6) seconds.
The Locking Key symbol (
, item 1) appears in the top left corner of the screen.
Lines which are no longer accessible are preceded by a dash “–“ (
•
Lines which remain operational keep their initial line access symbol.
Figure 7-32. Installing the Locking Key
7.9
Unlocking the Control Panel
To disable the Locking Key:
•
Simultaneously press the UP and the DOWN keys for at least six (6) seconds.
The Locking Key symbol disappears.
Clinician's Manual 7-37
Operating Procedures
•
The initial line access symbol is displayed in front of each line.
7.10
Starting Ventilation
Before starting ventilation, refer to Appendix
Operational Verification Checklist
parameter values in the Preferences menu (refer to section
” on page
WARNING:
Verify the functionality of the alarm conditions before connecting the patient to the ventilator.
WARNING:
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.
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 7-33. Prompt to Start Ventilation
7-38
•
•
•
•
To start ventilation:
Press and release VENTILATION ON/OFF (
, item 1).
A “beep“ sounds.
The ventilation starts.
The values of the monitored parameters are displayed in the right-hand window.
Clinician's Manual
Figure 7-34. Starting Ventilation
Stopping Ventilation
7.11
Stopping Ventilation
WARNING:
Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient.
In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.
You can stop your ventilator at any time.
To stop the ventilator:
Press and hold the VENTILATION ON/OFF key (
, item 1) for three (3) seconds.
1.
•
A message prompting the user to keep the button pressed appears on the monitoring window, as shown in the graphic below:
Clinician's Manual 7-39
Operating Procedures
Figure 7-35. Stopping Ventilation (1)
2.
While keeping the VENTILATION ON/OFF key pressed:
•
A new message appears that directs the user to press the key again to confirm ventilation stop as shown in the following graphic.
Figure 7-36. Stopping Ventilation (2)
7-40
•
A double “beep“ sounds.
3.
4.
Press the VENTILATION ON/OFF key again within 5 seconds to confirm stop, otherwise ventilation will continue.
•
Ventilation stops.
•
•
, item
2) illuminates to indicate ventilation is on Standby.
A prompt for a new start of ventilation is displayed (see
).
Clinician's Manual
Turning Off the Ventilator
7.12
Turning Off the Ventilator
WARNING:
When the ventilator is switched back on after it was switched off while ventilation was in progress, it will immediately begin ventilating—without the user first having to press the VENTILATION ON/
WARNING:
Handle the ventilator with care after use, particularly when ambient temperatures are high. Some ventilator surfaces may be very hot, even if safety specifications are not exceeded.
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.
Note:
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.
Clinician's Manual 7-41
Operating Procedures
Page Left Intentionally Blank
7-42 Clinician's Manual
8 Internal Battery
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.
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.
WARNING:
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.
WARNING:
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.
8.1
Battery Capacity
The reserve capacity offered by the internal battery depends on the level of ventilation parameters, the environmental conditions (primarily in terms of temperature) and the physiological characteristics of the patient.
8-1
8-2
Internal Battery
With a fully charged battery at a normal room temperature of 25 °C (± 5 °C), the ventilator can be expected to operate on internal battery power for the average durations shown in
Checking the battery charge level requires that the ventilator be running on battery power at the time of the battery check. To check the battery charge level, temporarily disconnect the ventilator from AC power (while in Stand By mode or while providing ventilation) and read the percent charge level displayed adjacent to the battery icon displayed at the top of the ventilator's display screen.
Table 8-1. Internal Battery Reserve Capacity
Displayed Values Average Operating Time on
Internal Battery Power
1
11 hours (–10%) Vt = 200 ml (± 5 ml)
PIP = 10 mbar (± 2 mbar)
Rate = 20 bpm
Vt = 300 ml (± 5 ml)
PIP = 20 mbar (± 2 mbar)
Rate = 15 bpm
9 hours (–10%)
Vt = 500 ml (± 5 ml)
PIP = 30 mbar (± 2 mbar)
Rate = 15 bpm
Vt = 750 ml (± 5 ml)
PIP = 45 mbar (± 2 mbar)
Rate = 20 bpm
(Maximum Ventilation Parameters)
6.5 hours (–10%)
4.5 hours (–10%)
1.
Average durations shown are with a fully charged battery having less than 50 charge/recharge cycles.
8.2
Battery Operation
WARNING:
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.
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.
•
Clinician's Manual
Battery Operation
•
•
Battery reserve capacity is displayed on the right of the symbol.
Figure 8-1. Internal Battery Indicator
•
A loss of external supply alarm is activated.
If ventilation is stopped, the internal battery reserve capacity is displayed as a percentage of battery charge. See
Figure 8-2. Battery Reserve Capacity as a Percentage
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,
Clinician's Manual 8-3
Internal Battery depending on the power consumption of the ventilator), the internal battery reserve is then dis-
played in hours and minutes (rounded to the nearest 10 minutes). See
Figure 8-3. Battery Reserve Capacity in Hours and Minutes
8-4
The “LOW BATTERY“ and “EMPTY BATTERY“ alarms (see Chapter
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.
WARNING:
When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.
From the time that an “EMPTY BATTERY“ alarm is activated, if no external supply is connected to the ventilator, other alarms may be triggered due to insufficient supply voltage.
In the final discharge phase, the “EMPTY BATTERY” alarm will become continuous, and ventilation may be interrupted at any time during this phase.
Note:
The “EMPTY BATTERY” alarm symbol may disappear shortly before the ventilator completely stops, but it always triggers a final, continuous alarm.
8.3
Testing the Battery
Your ventilator continuously and automatically checks the state of the internal battery, even when the battery is not used as the main source of energy. The “BATTERY FAULT1“ alarm is activated whenever a problem is detected in the battery or the charger.
However, on a monthly basis you should disconnect the ventilator from the external power supply to check the integrity of the connections linking the internal battery to other ventilator components.
Clinician's Manual
Recharging the Battery
8.4
Recharging the Battery
In the event that the battery charge level is considered insufficient, as per the reserve capacity display, recharge of the internal battery is necessary. In general, it is recommended that the ventilator be allowed to charge when the battery drops below 80%, and that the ventilator be recharged systematically after storage and before using it again.
Note:
To avoid cycling and extend battery life while connected to an AC power source, the battery will not begin charging until it has dropped below an 85%-90% charge.
To charge the internal battery, do the following:
•
Connect the ventilator to the AC power source.
The “AC POWER” indicator illuminates (
The “INTERNAL BATTERY“ indicator flashes (
, item 2).
•
Figure 8-4. Power Indicators When Charging the Battery
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.
Clinician's Manual 8-5
8-6
Internal Battery
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 maximize 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.
Clinician's Manual
9 Cleaning
WARNING:
A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a double-limb circuit is used – is highly recommended. Refer
.”
WARNING:
To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
9.1
Cleaning the Ventilator
Clean all external panels and surfaces before and after each patient use and as often as necessary to keep the ventilator clean. You should clean the ventilator periodically, whenever it is soiled or dirty, before any maintenance operation, and before storing the ventilator.
WARNING:
Use all cleaning solutions and products with caution. Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator. Use only those solutions listed in
WARNING:
The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately.
WARNING:
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.
9-1
9-2
Cleaning
To clean the surface of the ventilator:
1.
Dip a clean, soft cloth into a mixture of mild soap and water, or other approved cleaning solution. See
for a list of approved cleaning solutions.
2.
Table 9-1. Approved Cleaning Solutions for Exterior Ventilator Surfaces
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
Squeeze the cloth thoroughly to remove excess liquid.
3.
Lightly wipe the external casing of the ventilator, taking care not to allow excess moisture to enter any of the openings on the ventilator’s surface. See the warning, above.
4.
Dry the ventilator surface with a clean, soft, lint-free cloth.
9.2
Cleaning the Accessories
Follow the accessory manufacturer’s instructions for cleaning the ventilator’s accessories and components, including the patient circuit.
WARNING:
After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.
WARNING:
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.
Clinician's Manual
Cleaning the Exhalation Block
9.3
Cleaning the Exhalation Block
WARNING:
The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically. The exhalation block should be changed every 4 months and cannot be reused with any other patient.
WARNING:
Ensure that the exhalation block is completely dried after cleaning and prior to use.
The exhalation block can be removed easily from the device by first removing a captive screw, accessible through the bottom of the device (see section
“
Whenever the exhalation block is removed or after installing a new one, you must calibrate the exhalation flow sensor. See section
Calibrating the Exhalation Flow Sensor
Clinician's Manual 9-3
Cleaning
Page Left Intentionally Blank
9-4 Clinician's Manual
10 Routine Maintenance
WARNING:
On a DAILY basis, inspect the patient circuit to ensure that it shows no signs of damage, is properly connected, and is operating correctly without leakage.
WARNING:
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 authorized and qualified by Covidien should repair, open or service the ventilator.
10.1
Calibrating the Exhalation Flow Sensor
Each time the exhalation block or circuit is removed and reinstalled or after installing a new exhalation block, the exhalation flow sensor must be recalibrated before the using the ventilator. This process is automatic and does not require the use of a measurement device.
Note:
Calibration may be done with either an adult or pediatric circuit; however, Pediatric YES/NO must be appropriately selected in the ventilator Preferences Menu.
To calibrate the exhalation flow sensor:
See
1.
Ensure the ventilator is on and in Standby mode.
2.
Ensure the Locking Key is disabled (see section
).
10-1
Routine Maintenance
Figure 10-1. Blocking the Patient Wye (Double-Limb Circuit Shown)
10-2
7.
3.
Obstruct the patient wye’s open connector using the fleshy portion of your palm to make a good seal
4.
Press the MENU key to access the alarm settings menu – if this is not the menu currently displayed.
5.
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.
Figure 10-2. Calibrating the Exhalation Flow Sensor (1)
key. “YES“ is displayed instead of “OFF“.
Clinician's Manual
Calibrating the Exhalation Flow Sensor
Figure 10-3. Calibrating the Exhalation Flow Sensor (2)
8.
Press the ENTER key to start calibration.
•
The message “... Exp. calib. Processing …“ is displayed in the window on the right, while calibration is in progress.
Figure 10-4. Calibrating the Exhalation Flow Sensor (3)
•
•
•
•
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.
Note:
No message is displayed when the ventilator passes calibration; a message only is displayed if the calibration has failed.
Clinician's Manual 10-3
Routine Maintenance
•
•
•
In the event of calibration errors, the following events occur:
The ventilator sounds a long beep at each point that fails calibration.
An alarm is activated, and the message “CALIBRATION FAIL“ is displayed.
The ventilator takes the previously saved value as the default and automatically switches to the next calibration point.
If a “CALIBRATION FAIL” alarm occurs, do the following:
1.
Ensure the exhalation block is properly seated.
2.
Ensure an approved circuit is in use (see circuit documentation).
3.
Check the integrity of the circuit and all connections.
4.
Ensure the correct circuit type is selected in the ventilator preferences.
5.
Repeat the calibration procedure keeping a tight seal over the end of the circuit during calibration.
For more information on the “CALIBRATION FAIL” alarm, see section
10.2
Calibrating the FiO
2
sensor
Each time the FiO
2
sensor is removed and reinstalled, and on a weekly basis, the FiO
2
sensor must be recalibrated before using the ventilator. This process does not require the use of a measurement device.
To calibrate the FiO
2 sensor:
See
10-4 Clinician's Manual
Figure 10-5. Calibrating the FiO
2
sensor (1)
Calibrating the FiO2 sensor
1.
Ensure the ventilator is on and in Standby mode.
2.
Ensure the Locking Key is disabled (see section
, “
3.
Connect the FiO
2
sensor to the ventilator (see section
” on page
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 FiO
2
setup line.
6.
Press the ENTER key twice to access the Patient column (central column) of the FiO
2
setup line.
•
"OFF" flashes in the central column
•
•
A zoom of "OFF" is displayed flashing in the window on the right
The message “FiO
2
Calibration?” is displayed in the window on the right.
Clinician's Manual 10-5
Routine Maintenance
Figure 10-6. Calibrating the FiO
2
Sensor (2)
7.
Press the UP or DOWN key. “YES” is displayed instead of “OFF”.
Figure 10-7. Calibrating the FiO
2
Sensor (3)
8.
Press the ENTER key to start calibration.
•
The message “FiO
2
calib. Processing...” is displayed in the window on the right while calibration is in process.
Figure 10-8. Calibrating the FiO
2
Sensor (4)
10-6
•
A short beep sounds to confirm that the FiO
2
sensor has been calibrated.
Clinician's Manual
Replacing the Air Inlet Filter
9.
Press the ENTER key to exit the FiO
2
setup line.
Note:
The FiO
2
sensor calibration procedure, once initiated, must run to its conclusion.
•
In the event of calibration errors the following events occur:
An alarm is activated and the message “FiO
2
CALIBRATION FAIL” is displayed.
The ventilator takes the previously saved value as the default.
•
For more information on the “FiO
2
CALIBRATION FAIL” alarm (See Chapter
“
”).
10.3
Replacing the Air Inlet Filter
WARNING:
Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary, replace the filter before the recommended replacement period is over. This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
WARNING:
Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause serious damage to the ventilator.
WARNING:
The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.
If the ventilator is used indoors, the condition of the air inlet filter should be checked monthly. If the ventilator is used outdoors or in a dusty environment, the air inlet filter should be checked weekly and replaced as necessary.
To replace the air inlet filter:
1.
Hold the filter between your fingers (see
2.
Remove the filter (
, item 2) and discard it.
3.
Place the new filter in the device, while ensuring that:
•
•
The fine particle side of the filter faces outwards, away from the ventilator.
The filter is properly installed in its housing. Proper installation of the filter prevents particles from entering the device.
Clinician's Manual 10-7
Routine Maintenance
Figure 10-9. Replacing the Air Inlet filter
10-8
10.4
Recommended Schedule of Maintenance
Consumables and Replacement Intervals
When used under normal circumstances – a relatively dust-free atmosphere, and without damage to the device and its components (shocks, cracks, significant dirt) – the intervals for replacing the ventilator’s consumable elements are as follows:
Table 10-1. Consumables and Replacement Intervals
Elements Recommended Replacement Intervals
Air Inlet Filter
(Foam + Fine Particle)
Inspirited Bacteria Filter
Once a month or more often, depending on the extent of soiling
See manufacturer’s recommendation
Patient Circuit See manufacturer’s recommendation
Single use Single patient
FiO
2
Sensor 14 to 18 months or more often in case of persistent calibration failure
4 months(*) (and for each new patient) Exhalation Block
Note:
For a list of parts and accessories, see Appendix
representative or consult www.puritanbennett.com.
Note:
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
Clinician's Manual
Recommended Schedule of Maintenance 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.
Note:
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.
WARNING:
The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically (refer to section
”). The exhalation block should be changed every 4 months and cannot be reused with any other patient.
Failure to observe these recommendations may result in a loss of performance, excessive overheating, a loss of certain functions and, in the long term, compromise the longevity of the ventilator.
Maintenance of the Internal Battery
The internal battery does not need to be removed to verify its correct operation.
Periodic Test of the Internal Battery
Your ventilator continuously and automatically checks the state of the internal battery, even when the internal battery is not used as the main power source.
However, the battery charge status should be checked MONTHLY by disconnecting the ventilator from external power supplies (see section
”). Such a test is imperative after opening the ventilator or after a prolonged period of non-use (one month or more), in order to ensure the correct operation of internal connections linking the battery to other components.
WARNING:
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.
Clinician's Manual 10-9
Routine Maintenance
WARNING:
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.
Replacement of the Internal Battery
The internal battery should be replaced when the battery capacity drops below 3840 mAh. Keep in mind that, for environmental protection, the ventilator and its components – including its internal battery – cannot be disposed of with household waste. You must submit the ventilator and its components for suitable selective collection and possible recycling and observe all applicable regulations.
Note:
As the total number of battery charge/discharge cycles approaches 300, a drop in potential of as much as
20% may be detected.
10.5
Service Assistance
WARNING:
If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER.
If necessary, remove the patient from the ventilator and provide an alternative means of ventilation.
WARNING:
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 qualified service personnel should open, repair or service the ventilator.
In the event of a problem with the ventilator, see Chapter
, “
cannot determine the cause of the problem, contact your equipment supplier or Covidien.
For more information and local Covidien Technical Service Contact details, see the
section in Preface chapter.
10-10 Clinician's Manual
A Patient/Caregiver Checklist
What the Patient and Caregiver Must Understand
presents a summary of the topics that patients and caregivers must understand in
order to use the ventilator successfully. Some topics may not apply to some patients, while other patients may require additional information.
The Clinician’s Responsibility
It is the responsibility of the clinician or clinical educator to ensure that both the patient and the caregiver fully understand the topics listed below.
List of Topics
Need for ventilation
Table A-1. Patient/Caregiver Checklist
References
Clinician
Intended use of the ventilator Chapter
The principles of operation for the ventilator Appendix
”
Supplies required for ventilation, and their sources
Clinician; Appendix
;” Appendix
Schedule for ventilation Clinician
How and why to monitor the patient’s condition.
Clinician
The importance of coordinating care for the patient.
Resources for respite care.
Clinician
Clinician
Choices about future care.
The purpose of advanced directives.
How to check the patient’s vital signs.
Clinician
Clinician
Clinician
The significance of the patient’s ease of breathing. Clinician
What to note about the patient’s skin, mucus membranes, and secretions, and their significance.
Clinician
How to recognize the signs of infection, and how to respond.
Clinician
A-1
Patient/Caregiver Checklist
Table A-1. Patient/Caregiver Checklist (Continued)
List of Topics References
Whom to contact for medical emergencies, equipment emergencies, or power emergencies.
;”
”
Equipment and phone numbers to have available in cases of emergency.
, “
”
How to contact other resources for assistance
(health aides, attendants, therapists, and so on).
Clinician
The importance of routine medical appointments and medical testing.
Clinician
Power sources for the ventilator and how to connect them
” and section
”
The meaning of keys and buttons.
The meaning of symbols and markings.
How to connect the patient to the ventilator via the patient breathing circuit.
The parts and purpose of the breathing circuit.
”
”
”
How and when to inspect, clean, and replace the patient circuit.
,
How to recognize and respond to problems with the breathing circuit.
”
The parts and purpose of the nasal interface or mask.
Care of the nasal interface or mask.
Clinician or manufacturer’s instructions for use.
Clinician or manufacturer’s instructions for use.
How to recognize and respond to problems with the nasal interface or mask.
Clinician or manufacturer’s instructions for use.
How to install the humidifier.
”
How to perform alarms tests, and how to respond if the alarms tests fail.
Appendix
;”
”
How to change the Exhalation Block.
”
Replacement interval for outlet filters (per the filter manufacturer’s instructions).
, “
”
Setting ventilation parameters and the importance of each
Ventilator alarm settings; understanding the purpose and function of each.
Recognizing alarm priority level
What to do in case of ventilator alarms and problems
”
A-2 Clinician's Manual
List of Topics
Table A-1. Patient/Caregiver Checklist (Continued)
References
What to do if the ventilator alarms inappropriately. Section
”
The oxygen setting, and why it is required.
Clinician
How to connect the oxygen source to the ventilator
, “
How to determine the quantity of oxygen being delivered, and how to adjust the quantity.
, “
Safety rules for the use of oxygen.
Chapter
section
How to connect the FiO
2
sensor to the ventilator
, “
How to recognize and respond to problems with the oxygen supply.
Clinician
How to respond to dyspnea Clinician
Techniques to prevent aspiration of vomit.
Clinician
Clinician's Manual A-3
Patient/Caregiver Checklist
Page Left Intentionally Blank
A-4 Clinician's Manual
B Specifications
B.1
Physical
Ventilator Weight
Ventilator Dimensions
Table B-1. Physical Description (Excluding Accessories)
9.9 lb. (4.5 kg)
Connectors
9.25 in wide x 12.40 in deep x 6.0 in high
(235 mm wide x 315 mm deep x 154 mm high)
Inspiratory limb connector: ISO 22 mm (OD) conical
Exhalation limb connector (on exhalation block): ISO 22 mm (ID) conical
Oxygen inlet: Female Connector with valve
2000 ml
Device airway volume
Breathing circuit volume
• Adult, dual limb
• Pediatric, dual limb
• Adult, single limb
• Pediatric, single limb
Air Inlet Filter
1150 ml
670 ml
550 ml
300 ml
Inspiratory Bacteria Filter
Requirement
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)
Maximum allowable flow resistance: 4 mbar at 60 lpm
B.2
Electrical
Voltage
100 VAC to 240 VAC
12 VDC
30 VDC
Table B-2. AC Electrical Supply
Frequency Consumption
50 Hz / 60 Hz
NA
NA
180 VA max
8.3 A
3.3 A
B-1
Specifications
Voltage
Full-load capacity
Ampere-hour rating
Table B-3. Internal Lithium Ion Battery
25.2 VDC
4.8 Ah
Watt hour rating
Charging current
• Standby mode
• Ventilation mode
On standby: 1.5 Ah
During ventilation: 0.5 Ah
124Wh to 126Wh
1.5 A/hr. (duration: < 6 hr.)
0.5 A/hr. (duration: < 13 hr.)
Average operating time at 25 °C (± 5 °C) with a fully charged battery (having less than 50 charge/discharge cycles) at the following displayed values:
Vt = 200 ml (± 5 ml), PIP = 10 mbar (± 2 mbar), Rate = 20 bpm
Vt = 300 ml (± 5 ml), PIP = 20 mbar (± 2 mbar), Rate = 15 bpm
Vt = 500 ml (± 5 ml), PIP = 30 mbar (± 2 mbar), Rate = 15 bpm
Vt = 750 ml (± 5 ml), PIP = 45 mbar (± 2 mbar), Rate = 20 bpm
(maximum settings)
11 hr. (–10%)
9 hr. (–10%)
6.5 hr. (–10%)
4.5 hr. (–10%)
Table B-4. Remote Alarm
Remote Alarm Port:
Also known as the Nurse’s Call port, it provides for remote alerts of ventilator alarm conditions.
An example of a setting that requires such a feature is when the ventilator is used in an isolation room.
The ventilator signals an alarm using a normally open (NO) or a normally closed (NC) signal.
A remote alarm is activated when an alarm condition occurs, unless the audio paused function is active or the ventilator power switch is turned off.
The alarm delay, once generated from the ventilator, to the nurse call output/input cable connectors is less than 100 ms.
The remote alarm port is an 8-pin female connector. Allowable current is 100 mA at24 VDC
(maximum).
Nurse call pin-out (view from back of ventilator)
Pin Signal
5
6
7
1 relay common
2 normally open (NO)
3 normally closed (NC)
4 remote supply -
(not used)
8
RX Signal (not used)
TX Signal (not used) remote supply +
(not used) not used
Remote Alarm
Wire color
black brown orange
N/A
N/A
N/A
N/A
N/A
B-2 Clinician's Manual
B.3
Indicators and Alarms
Table B-5. Power Indicators
Ventilation ON/OFF
• Blue in standby mode
• Not lit if ventilation is in progress.
AC power DC power Internal Battery
Green Green • Flashing if the battery charge is in progress.
• Continuously lit if the ventilator is powered by the internal battery.
Table B-6. Alarm Indicators
High Priority Medium Priority
Red flashing LED Yellow flashing LED
Audio Paused
60 s ± 1 s
Table B-7. Audio Alarms
Alarm Volume
65 to 80 dBA ± 10% at 1 meter
B.4
Performance
B.4.1
Specifications
Table B-8. Performance Parameter Specifications and Tolerances
1
Volume
Pressure
Time
Rate
50 to 2000 ml
5 to 55 mbar
0.3 to 2.4 s
1 to 60 bpm
Inspiratory Sensitivity 0P to 5
Exhalation Sensitivity 5 to 95%
Vt Sigh
I:E
I/T
Vt x1 to Vt x 2
1:4 to 1:1
20% to 50%
± (10 ml + 10%)
± (1 mbar + 10%)
± 50 ms or 10%, whichever is greater
± 1 bpm
N/A
± (4 lpm +10%) of target exhalation flow based on E Sens within 50ms
± (20 ml + 20%)
± 50 ms or 10%, whichever is greater
± 50 ms or 10%, whichever is greater
1.
The ventilator parameters’ displayed values could vary based on patient settings.
Indicators and Alarms
Clinician's Manual B-3
Specifications
B.5
Monitored Parameters
Table B-9. Monitored Parameter Tolerances
Ventilator Parameters
Peak Inspiratory Pressure (PIP)
Positive End Expiratory Pressure (PEEP)
1
Tolerances
± (2 mbar + 8%)
± (2 mbar + 8%)
Inspiratory Tidal Volume (VTI)
Exhalation Tidal Volume (VTE)
Total Breath Rate (Rtot)
I:E Ratio (I:E)
I/T Ratio (I/T)
± (10 ml + 10%VTI) x Rate
± (10 ml + 10%VTE) x VTE
± 1 bpm
± 50 ms or 10%, whichever is greater
± 50 ms or 10%, whichever is greater
Inspiratory Time (I Time)
Exhalation Time (E Time)
Inspiratory Minute Volume (M VoI)
Vt Sigh
FiO
2
Leak
Apnea Index (AI)
Apnea Time
% Spontaneous (Spont)
Peak Airway Pressure (Paw)
± 100 ms
± 100 ms
± (10ml + 10%)
± (20ml + 20%)
± (2.5% + 2.5% FiO
2
± (3 lpm + 20%)
± 1 ev/h
± 1 s
± 1 %
± (2 mbar + 8%)
)
1.
The Puritan Bennett™ 560 Ventilator does not have the capability to reduce pressure below the PEEP pressure during the exhalation phase.
B-4 Clinician's Manual
Range, Resolution, and Accuracy
B.6
Range, Resolution, and Accuracy
lists the ranges, resolutions, and accuracies for ventilator settings, alarm settings, and patient data.
Mode
Ventilator Settings
Table B-10. Ventilator Range, Resolution, and Accuracy
Range, Resolution, and Accuracy
Tidal volume (Vt)
Range: V A/C, P A/C, V SIMV, P SIMV, PSV, CPAP
Resolution: N/A
Accuracy: N/A
Default value: P A/C
Range: 50 mL to 2000 mL
Resolution: 10 mL
Accuracy: ± (10 ml + 10%) of setting
Default value: 500 mL
Depends on: Insp time, R-Rate in V SIMV and P SIMV
Depends on: Rate and I:E (I/T) in V A/C
Inspiratory Pressure
(Pi)
Pressure support
(P Support)
I:E Ratio (I:E)
I/T Ratio (I/T)
Range: 5 mbar to 55 mbar in valve configuration
Range: 6 mbar to 30 mbar in leak configuration
Resolution: 1 mbar
Accuracy: ± (1 mbar + 10%) of Pi + PEEP setting
Default value: 15 mbar
Depends on PEEP when Relative Pressure is set to YES
Range: OFF or 5 mbar to 55 mbar in valve configuration
Range: 6 mbar to 30 mbar in leak configuration
Resolution: 1 mbar
Accuracy: ± (1 mbar + 10%) of P Support + PEEP setting
Default value: 15 mbar
Depends on PEEP when Relative Pressure is set to YES
Range: from 1:1 to 1:4
Resolution: 1/0.1 s
Accuracy: ± 50 ms or 10%, whichever is greater
Default value: 1/2
Range: 20% to 50%
Resolution: 1%
Accuracy: ± 50 ms or 10%, whichever is greater
Default value: 33%
Clinician's Manual B-5
Specifications
Respiratory rate (R-Rate)
Table B-10. Ventilator Range, Resolution, and Accuracy (Continued)
Ventilator Settings
Inspiratory time (Insp Time)
Range, Resolution, and Accuracy
Range: 0.3 s to 6.0 s in P A/C and V A/C modes; 0.3 s to 2.4 s in P SIMV and V
SIMV modes
Resolution: 0.1 s
Accuracy: ± 50 ms or 10%, whichever is greater
Default value: 1.5 s
Depends on: R-Rate, Vt in V SIMV mode
Depends on: R-Rate in P SIMV mode
Range: 1 bpm to 60 bpm in V A/C and P A/C modes
1 bpm to 40 bpm in P SIMV and V SIMV modes
Resolution: 1 bpm
Accuracy: ± 1 bpm
Default value: 13
Depends on: Insp Time and Vt in V SIMV mode
Depends on: Insp Time in P SIMV modes
Depends on: Vt in V A/C mode
Inspiratory sensitivity (I Sens)
Exhalation sensitivity (E Sens)
Ramp (Flow Pattern)
PEEP
Rise time
Range: 0P-5
Resolution: 1
Accuracy: NA
Default value: 2 in CPAP, I Sens is set to 2 and is not adjustable
Range: 5% to 95% of peak flow
Resolution: 5%
Accuracy: ± (4 lpm + 10%) of target exhalation flow based on E Sens within
50ms
Default value: 25%
In CPAP, E Sens is fixed at 25% and is not adjustable.
Range: Square (SQ), descending ramp (D), sinusoidal (S)
Resolution: N/A
Default value: Descending ramp (D)
In V SIMV, flow pattern is set to square and is not adjustable
Range: OFF (0.5 mbar) to 20 mbar
Resolution: 1 mbar
Accuracy: ± (1 mbar + 10%) mbar
Default value: OFF
Depends on: Pi in P A/C and PSV modes when Relative Pressure is set to YES
Depends on: P Support and P Control in P SIMV mode when Relative Pressure is set to YES
Depends on: P Support in V SIMV mode when Relative Pressure is set to YES
Range: 1-4
Resolution: 1
Default value: 2
Depends on: Insp time
B-6 Clinician's Manual
Clinician's Manual
Range, Resolution, and Accuracy
Table B-10. Ventilator Range, Resolution, and Accuracy (Continued)
Backup rate
Ventilator Settings Range, Resolution, and Accuracy
Range: OFF or 4-40 bpm
Resolution: 1 bpm
Default value: 13
Depends on: Min I time
In P SIMV and V SIMV, Backup rate = Max (8, R-Rate)
Apnea time
Minimum Inspired Tidal Volume
(Min VTI)
Range: AUTO or 1-60 s
Resolution: 1 s
Default value: AUTO
Depends on: Backup R
In PSV, Apnea time: AUTO = 60/Backup R
In V SIMV or P SIMV, Apnea Time: AUTO = 12
In CPAP, Apnea Time: AUTO = 30
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: 300
Depends on: Max VTI
Maximum Inspired Tidal Volume
(Max VTI)
Minimum Exhaled Tidal Volume
(Min VTE)
Maximum Exhaled Tidal Volume
(Max VTE)
Maximum Respiratory Rate
(Max Rtot)
Minimum Peak Inspiratory Pressure
(Min PIP)
Maximum Peak Inspiratory Pressure
(Max PIP)
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 2000 mL
Depends on: Min VTI
Range: 30 mL to 1990 mL
Resolution: 10 mL
Default value: 300
Depends on: Max VTE
Range: 80 mL to 3000 mL
Resolution: 10 mL
Default value: 1000
Depends on: Min VTE
Range: 10 bpm to 70 bpm
Resolution: 1 bpm
Default value: OFF
Depends on: R-Rate
Range: PIP- 20% (not adjustable in pressure breath)
Range: 2-52 (in volume breath)
Resolution: N/A
Range: PIP+ 20% (not adjustable in pressure breath)
Range: 12-60 (in volume breath)
Resolution: N/A
B-7
Specifications
Table B-10. Ventilator Range, Resolution, and Accuracy (Continued)
Ventilator Settings
Minimum inspiratory time
(Min I time)
Range: 0.1 to 2.8 s
Resolution: 0.1 s
Range, Resolution, and Accuracy
Default value: AUTO (Rise time + 300 ms)
Depends on: Max I Time, Backup R, Rise time
Maximum inspiratory time
(Max I time)
Minimum Fraction of Inspired Oxygen
(Min FiO
2
)
Maximum Fraction of Inspired Oxygen
(Max FiO
2
)
Range: 0.8 to 3 s
Resolution: 0.1 s
Default value: AUTO {Min [3 s; (30/R-Rate)]}
Depends on: Min I Time, R-Rate
Range: 18 to 90%
Resolution: 1%
Default value: OFF
Depends on: Max FiO
2
Range: 30 to 100%
Resolution: 1%
Default value: OFF
Depends on: Min FiO
2
B.7
Environmental
The following environmental conditions shall be observed:
Table B-11. Environmental Conditions for Storage or Transport
Temperature
-40 °C to +70 °C
(-40 °F to +158 °F)
10% to 95% RH 500 hPa to 1060 hPa (7.2 psi to 15.4 psi)
-152 m to 3964 m
(500 ft to 13,000 ft)
Temperature
+5 °C to 40 °C
(+41 °F to 104 °F)
Table B-12. Environmental Conditions for Operation
Humidity Atmospheric pressure Altitude
10% to 95% RH 600 hPa to 1100 hPa
(8.7 psi to 16.0 psi)
-152 m to 3964 m
(-500 ft to 13,000 ft)
Under extreme conditions of use, within the limits of a supply voltage of –20% and temperatures ranging from normal to 45 °C (113 °F) with ≤ 75% RH, the ventilator should not malfunction or 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 Clinician's Manual
USB
B.8
USB
B.9
Pneumatic
Table B-13. USB Memory Device Specifications
Characteristics
USB compatibility
Supported formats
USB flash memory USB 2.0 or USB 1.1
Memory file format
Number of files
USB size
USB 32 bit format (sector size: 512 – 2,048 bytes)
Maximum 999
128 MB to 4 GB
Table B-14. Data Transfer Characteristics
Ventilator data description
Trends capacity 86 MB
Capacity
Events capacity
Monitoring capacity
512 KB or 5,500 events
42 MB/ 48 hours
Inspiratory
Table B-15. Airway Resistances
Exhalation
1.0 mbar at 30 lpm flow ± 0.1 mbar
3.7 mbar at 60 lpm flow ± 0.1 mbar
0.5 mbar at 30 lpm ± 0.1 mbar
1.1 mbar at 60 lpm ± 0.1 mbar
Table B-16. Patient Circuit Resistances
1
Adult Double Limb
2 mbar at 60 lpm flow
2
Pediatric Double Limb
2 mbar at 30 lpm flow
1.
Includes exhalation valve
2.
Values obtained from the manufacturer’s directions for use.
Table B-17. Air Inlet Resistance (Filter)
1.1 cmH
2
O (1.079 mbar) at 30 lpm flow ± 0.1 cmH
2
O
Table B-18. Oxygen Inlet Specifications
Maximum pressure
50 kPa (7 psi)
Maximum flow
15 lpm
Clinician's Manual B-9
Specifications
Working pressure
5 mbar–
55 mbar
Table B-19. Performance Specifications
Sound pressure level
Maximum pressure limit
Internal compliance
(ventilator)
30 dBA (per NF
EN ISO 17510-1 test conditions)
Inspiratory triggering response time (Ttr)
B.10
Manufacturer’s Declaration
The following tables,
, contain the manufacturer’s declarations for
the ventilator’s electromagnetic emissions, electromagnetic immunity, and recommended separation distances between the ventilator and portable and mobile RF communications equipment, as well as a list of compliant cables.
WARNING:
Portable and mobile RF communications equipment can affect the performance of the
Puritan Bennett™ 560 Ventilator. Install and use this device according to the information contained in this manual.
WARNING:
The ventilator should not be used adjacent to or stacked with other equipment, except as specified in this manual. If adjacent or stacked use is necessary, the ventilator should be observed to verify normal operation in the configurations in which it will be used.
The Puritan Bennett 560 Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment.
RF emissions
CISPR 11 / EN 55011
RF emissions
CISPR 11 / EN 55011
Harmonic emissions
IEC / EN 61000-3-2
Voltage fluctuations/ flicker emissions
IEC / EN 61000-3-3
Table B-20. Electromagnetic Emissions
Group 1
Class B
Class A
Complies
The ventilator uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The ventilator is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
B-10 Clinician's Manual
Clinician's Manual
Manufacturer’s Declaration
Table B-21. Electromagnetic Immunity
The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should ensure that it is used in such an environment.
Immunity Test IEC / EN 60601 Test Level Compliance Level
Electrostatic discharge (ESD)
IEC / EN 61000-4-2
Electrical fast transient/burst
IEC / EN 61000-4-4
Surge
IEC / EN 61000-4-5
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV lines/lines
± 2 kV lines/earth
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV lines/lines
± 2 kV lines/earth
Electromagnetic
Environment–
Guidance
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material, the relative humidity should be at least 30%.
AC power (“mains”) quality should be that of a typical commercial or hospital environment.
AC power (“mains”) power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC / EN 61000-4-11
< 5% U
T
(> 95% dip in UT for 0.5 cycle)
40% U
T
(60% dip in UT for 5 cycles)
Power frequency
(50/60 Hz) magnetic field
IEC/ EN 61000-4-8
70% U
T
(30% dip in UT for 25 cycles)
< 5% U
(> 95% dip in UT for 5 s)
3 A/m
T
< 5% U
T
(> 95% dip in UT for 0.5 cycle)
40% U
T
(60% dip in UT for 5 cycles)
70% U
(30% dip in UT for 25 cycles)
< 5% U
3 A/m
T
T
(> 95% dip in UT for 5 s)
AC power (“mains”) power quality should be that of a typical commercial or hospital environment. If the user of the ventilator requires continued operation during power mains interruptions, it is recommended that the ventilator be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note:
UT is the AC mains voltage prior to application of the test level.
B-11
Specifications
Table B-22. Electromagnetic Immunity—Conducted and Radiated RF
The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment.
Immunity Test IEC / EN60601 -1-2 Test
Level
Compliance Level Electromagnetic Environment-
Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the ventilator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 0.35√P
Conducted RF
IEC / EN 61000-4-6
3 Vrms
150 kHz to 80 MHz outside
ISM bands
1
3 Vrms
150 kHz to 80 MHz outside ISM bands
10 Vrms inside ISM bands
1
10 Vrms inside ISM bands d = 1.2√P
Radiated RF
IEC / EN 61000-4-3
10 V/m 80 MHz to 2.5 GHz
10 V/m 80 MHz to 2.5
GHz d = 1.2√P80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)
2
.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey
3
, should be less than the compliance level in each frequency range.
4
Interference may occur in the vicinity of equipment marked with the following symbol:
B-12 Clinician's Manual
Clinician's Manual
Manufacturer’s Declaration
Table B-22. Electromagnetic Immunity—Conducted and Radiated RF (Continued)
Note:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
1.
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.
2.
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.
3.
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.
4.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
0.1
1
10
Table B-23. Recommended Separation Distances
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ventilator as recommended below, according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum
Output Power of
Transmitter (W)
150 kHz to 80 MHz
(outside ISM bands)
150 kHz to 80 MHz
(in ISM bands)
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01
d = 0.35 √P
0.035 m 0.12 m
d = 1.2 √P
0.12 m
d = 1.2 √P
0.23 m
d = 2.3 √P
0.11 m
.35 m
1.1 m
0.38 m
1.2 m
3.8 m
0.38 m
1.2 m
3.8 m
0.73 m
2.3 m
7.3 m
B-13
Specifications
Table B-23. Recommended Separation Distances (Continued)
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ventilator as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter
150 kHz to 80 MHz
(outside ISM bands)
150 kHz to 80 MHz
(in ISM bands)
80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 0.35 √P d = 1.2 √P d = 1.2 √P d = 2.3 √P
100 3.5 m 12 m 12 m 23 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note:
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.
Note:
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.
Note:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
B-14 Clinician's Manual
Standards Compliance and IEC Classification
Table B-24. Compliant Cables and Accessories
Cable or Accessory
UK AC power cable assembly
Maximum length
1.8 m (5.9 ft)
Japan AC power cable assembly
China AC power cable assembly
South Africa AC power cable assembly
India AC power cable assembly
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
Australia AC power cable assembly
Europe AC power cable assembly
Canada AC power cable assembly
Nurse call cable
12V DC car adapter cable
Oxygen inlet connector
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
5 m (16.4 ft)
5 m (16.4 ft)
–
B.11
Standards Compliance and IEC Classification
•
•
•
•
General Standards
Medical Electrical Equipment: General Requirements for Safety IEC 60601-1:1988 and all its amendments up to 1995 and EN 60601-1:1990.
The ventilator will be constructed to comply with the following product Classifications as detailed in
Clause 5 of 60601-1:
–
Class II Equipment
–
Internally Powered Equipment
–
Type BF Applied Parts
–
IP31 with respect with respect to access to hazardous parts and ingress of moisture
–
Not suitable for use in the presence of flammable anesthetic mixtures
–
Not suitable for sterilization
–
Suitable for continuous operation
–
Detachable power supply cable
Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment - Part 1: General
Requirements for Safety.
UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety: 2003.
Clinician's Manual B-15
Specifications
•
•
•
•
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 60601-1-8:2006 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).
Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets EN ISO 5306-
1:2004.
•
Air Transportation Standards
Environmental Conditions and Test Procedures for Airborne Equipment - RTCA/DO-160:2007.
B-16 Clinician's Manual
C Theory of Operation
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 conversion so the device can switch between the three available power sources to provide power to the internal electronics.
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.
C-1
Theory of Operation
The flow measurement is automatically corrected as a function of the atmospheric pressure measured inside the ventilator with the Altitude Compensation feature
*
. The flow and volume are in
Body Temperature Pressure Saturated (BTPS) conditions. This necessitates that periodic inspections for calibrating the sensors be performed by maintenance technicians authorized by Covidien (see 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.
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.
for an illustration of the ventilator’s gas delivery system.
Figure C-1. Gas Delivery System
C-2
1
2
3
Air filter
Screen
FiO
2 port
21
22
23
O
2
solenoid
Turbine control PCB
Power switch
*.
The Altitude Compensation feature is enabled (set to “YES” on the Setup Screen) by default and should remain at this setting.
Clinician's Manual
Clinician's Manual
4
5
6
7
8
9
Not shown with humidifier, nebulizer, or additional water traps
Inspiratory filter
Exhalation valve pilot tube
Expiratory filter
Water trap
Exhalation valve
10 Exhaust port
11 Display and graphic PCB
12 Keyboard
13 Int bat
14 Power mgt PCB
15 Power supply
16 Cooling fan
17 CPU board
18 Exp flow sensor
19 SpO
2
port - not used
20 Nurse call cable
24 AC input
25 DC input
26 Mini type B PC port
27 Type A USB ports (2)
28 Nurse call port
29 Low pressure O
2
inlet
30 Air inlet
31 Exp block
32 Inspiratory tubing
33 Proximal pressure tube
34 Expiratory tubing
35 Buzzer board
36 Exp valve solenoid
37 Exp valve pressure transducer
38 Insp flow sensor
39 Insp pressure transducer
40 Prox pressure transducer
Operation
C-3
Theory of Operation
Page Left Intentionally Blank
C-4 Clinician's Manual
D Modes and Breath Types
D.1
Modes of Ventilation
This chapter is a general description of the various modes of ventilation and breath types available with the Puritan Bennett™ 560 Ventilator.
Note:
The default ventilation mode setting is P A/C; for more information, see below.
D.1.1
Assist/Control (A/C) Modes
•
When set to an Assist/Control mode, machine-initiated breaths are delivered at a clinician-set volume or pressure, inspiratory time, and rate. If the patient triggers a spontaneous breath between machine breaths, the ventilator will deliver a breath based on the volume or pressure settings and inspiratory time.
Whether initiated by the patient or the ventilator, all breaths are delivered at the same preset volume or pressure and inspiratory time.
•
The names of the Assist/Control modes are:
V A/C, if the breaths are based on a volume setting
P A/C, if the breaths are based on a pressure setting
D.1.2
SIMV Modes
•
When set to a SIMV (Synchronized Intermittent Mandatory Ventilation) Mode, machine-initiated breaths are delivered at a clinician-set volume or pressure, inspiratory time, and rate. These mandatory breaths are synchronized with patient effort. If the patient triggers a spontaneous breath between machine breaths, the ventilator will deliver a spontaneous breath, which is pressuresupported.
CPAP spontaneous breaths are not available in SIMV modes.
•
The names of the SIMV modes are:
V SIMV, if mandatory breaths are based on a volume setting
P SIMV, if mandatory breaths are based on a pressure setting
D-1
Modes and Breath Types
D.1.3
CPAP Mode
In CPAP, the ventilator maintains a constant level of pressure in the patient’s airway.
D.1.4
PSV Mode
PSV mode maintains a constant level of pressure in the patient’s airway during exhalation. In addition, the ventilator applies a clinician-set pressure (Pressure Support) to each of the patient’s breaths. This has the same benefits as CPAP, with the additional benefit of assisting the patient in moving gas into his or her lungs.
D.2
Breath Types
•
•
•
•
Breath types available from the ventilator are:
Volume controlled breaths in Assist/Control mode (in V A/C or V SIMV)
Pressure controlled breaths in Assist/Control mode (in P A/C or P SIMV)
Pressure-supported breaths in SIMV mode (V SIMV and P SIMV) or PSV
CPAP
D.2.1
Volume Breaths in Assist/Control Mode
In V A/C each delivered breath will be of the selected volume (Vt), delivered over the selected inspiratory time. Inspiration is triggered by patient-generated flow (for assisted breaths) or by the ventilator. For controlled breaths, breath rate (R-Rate) is the controlling parameter. For both controlled and assisted breaths, the inspiration is limited by the volume and is cycled by inspiratory time (Insp Time).
The shape of the flow waveform can be either a decelerated (D), a (SQ) square, or sinusoidal (S) flow patterns according to the Flow Pattern setting:
D-2 Clinician's Manual
Breath Types x y1 y2
Time
Airway pressure
Flow y3 Volume
1 Start of inspiration
2 End of inspiration
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 patientinitiated) breath. This restarts the period. At the conclusion of the period, the ventilator delivers another controlled breath.
Clinician's Manual D-3
Modes and Breath Types x y
1
Time
Airway pressure
Period
2 Machine breath
3 Patient-initiated breath
D.2.2
Pressure Control Breaths in Assist/Control Mode
In Assist/Control mode (P A/C), each delivered breath will maintain the selected pressure (Pi) maintained over the selected inspiratory time. Inspiration is triggered by patient-generated flow
(for assisted breaths) or by the ventilator (for controlled breaths; breath rate [R-Rate] is the controlling parameter). For both controlled and assisted breaths, the inspiratory pressure is limited to the pressure (Pi) setting, and is cycled by time.
The shape of the pressure waveform depends on the setting of the pressure rise time (Rise Time).
D-4 Clinician's Manual
Breath Types x Time y1 Airway pressure y2 Flow
1 Start of inspiration
2 End of inspiration
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.
Clinician's Manual D-5
Modes and Breath Types x y
1
Time
Airway pressure
Period
2 Machine breath
3 Patient-initiated breath
D.2.3
Volume Breaths in V SIMV Mode
In V SIMV the mandatory volume breaths deliver the selected volume (Vt) over the selected inspiratory time (Insp Time). Inspiration is triggered by patient-generated flow (for assisted breaths) or by the ventilator (for controlled breaths; breath rate [R-Rate] is the controlling parameter). For both controlled and assisted breaths, the inspiration is limited by the volume and is cycled by volume and time.
The shape of the flow of volume cycles is of the Square type. See the waveforms below.
D-6 Clinician's Manual
Breath Types x y1 y2
Time
Airway pressure
Flow y3 Volume
1
2
Start of inspiration
End of inspiration
SIMV mode will also deliver pressure supported breaths (see 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 “con-
Clinician's Manual D-7
Modes and Breath Types trolled“ cycles following an apnea event will be volume cycles. These cycles end as soon as a new inspiration trigger is detected.
When the patient triggers a breathing effort, the volume and pressure cycles alternate between each other according to the breath rate setting (R-Rate). All the cycles are synchronized on inspiration triggers. A period always includes a volume cycle, plus as many pressure cycles as have been triggered by the patient; beyond the period the following inspiration trigger will initiate a new volume cycle, and so forth. See the waveforms on the following page.
D-8 y Flow y1 Airway pressure
D.2.4
Pressure Supported Breaths in SIMV and PSV Modes
In P SIMV (or Synchronized) and PSV modes, the supported breaths maintain the selected pressure (P Support). Inspiration is triggered by patient-generated flow. The inspiration is terminated when inspiratory flow drops to the Exhalation Sensitivity (E Sens) setting.
In P SIMV, additional mandatory pressure breaths will be delivered, dependent on the selected
Breath Rate (Rate).
The shape of the pressure waveform depends on the setting of the pressure rise time (Rise Time).
See the waveforms shown below.
Clinician's Manual
Breath Types x y
Time
Flow y1 Airway pressure
1 End of inspiration
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%). See the waveforms shown below.
Clinician's Manual D-9
Modes and Breath Types
D-10 y1 y2
Airway pressure
Flow
1
2
Start of inspiration
End of inspiration
D.3
Ventilation Modes and Apnea
In SIMV mode with apnea time (Apnea Time) settings, the ventilator will sound an APNEA alarm if no patient effort occurs during the apnea time. During an APNEA alarm, the ventilator delivers breaths at a breath rate (backup rate) equal to the maximum of eight (8) and the breath rate setting (R-Rate). If the patient initiates a spontaneous breath, the ventilator will stop the controlled breaths and return to the previous operating parameters.
In PSV mode, the back-up rate is activated so that the ventilator will automatically begin to deliver breaths at the breath rate (Backup R) setting if no patient effort occurs for the Apnea Time setting.
The pressure during a back-up breath is equal to the Pressure Support (P Support) setting before the apnea condition began. If the patient initiates a spontaneous breath while the back-up rate is in effect, the ventilator will return to the previous operating parameters.
In CPAP, a backup rate is not set, but the operator must still set an apnea time (Apnea Time). In that case, the ventilator will sound an APNEA alarm if no breath is triggered by the patient in the apnea time; however, no back up breaths will be generated.
Clinician's Manual
E Operational Verification Checklist
•
•
•
The operational verification and safety checks listed in
below should be performed to ensure the ventilator is operating properly in the following circumstances:
Prior to using the ventilator with a patient
Monthly while the ventilator is in use
Following maintenance or changes in ventilator settings
If the ventilator fails any of the safety checks below, or if you cannot complete these checks, see
” or call the equipment supplier or Covidien (see section
WARNING:
Provide the patient with an alternate means of ventilation before conducting these tests.
WARNING:
To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
Table E-1. Operational Verification Checklist
1 Verify the proper appearance and cleanliness of the ventilator.
2 Verify all of the labels and markings on the ventilator are clear and legible.
3 Confirm the air inlet filter is clean and correctly installed.
4
5
6
Ensure the AC power cable does not exhibit any signs of damage, such as kinks, breaks, or damaged insulation.
Connect the AC power cable.
Ensure that all power supply indicators on the front panel flash, except for the AC power supply (mains) indicator, which should remain lit.
Push the power switch I/O to the I position to activate the ventilator test:
Check that the two alarm indicators and the Standby indicator (located close to the
VENTILATOR ON/OFF key) flash. Ensure also that the two alarm buzzers sound.
7
Perform the Functioning Alarms Test (see Appendix
Pass
Pass
Pass
Pass
Pass
Pass
Pass
E-1
Operational Verification Checklist
8
9
10
Table E-1. Operational Verification Checklist (Continued)
Verify the alarm volume is adapted to the patient environment. See section
for instructions on changing the alarm volume setting.
Verify that the preventive maintenance schedule for the ventilator is followed. See
Chapter
, “
Ensure the patient breathing circuit is correctly attached to the ventilator, with all the necessary components, and is free from any signs of damage and leaks. If exhaled volume monitoring is required, use the double-limb circuit for exhaled tidal volume monitoring.
Pass
Pass
Pass
E-2 Clinician's Manual
F Alarms Tests
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.
WARNING:
If the ventilator fails any alarm test or if you cannot complete these tests, see the
Troubleshooting section (refer to Chapter
your equipment supplier or Covidien (refer to section
WARNING:
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
) 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.
F.1
Low Pressure Test
WARNING:
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 following test to ensure the Low PIP alarm is properly set.
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.
F-1
Alarms Tests
4.
Wait for (Apnea Time + 2 seconds; Apnea time is not always 5 seconds), then ensure that:
•
•
• the High priority indicator (red color) lights up the “PATIENT DISCONNECTION” alarm is displayed the audible alarm sounds
5.
Press the ALARM CONTROL key once to pause the audible alarm.
6.
Press and hold the VENTILATION ON/OFF key for three (3) seconds, then release it. Press the VEN-
TILATION ON/OFF key again to confirm stop. The ventilator will switch to Standby mode and cancel the alarms.
F.2
Circuit Check Test
F.2.1
Performing a Circuit Check
Perform a circuit check whenever replacing or altering a patient circuit. Ensure the patient is fully disconnected from the ventilator prior to starting this test.
Note:
Before performing a circuit check, stop ventilation using the VENTILATION ON/OFF key, not the I/O switch.
If the I/O switch was used to stop ventilation, the circuit check function cannot be used unless first stopping ventilation using the VENTILATION ON/OFF key.
Press and hold the MENU key during power up to access the circuit check test screen.
1.
Figure F-1. Circuit Check Screen (Before Starting)
F-2
2.
Verify that the proximal pressure tube of the patient circuit is properly connected to the proximal pres-
, “
.)
3.
Verify that the exhalation valve tube is connected to the exhalation valve port.
Clinician's Manual
4.
Block the patient connection port of the patient circuit (see
Figure F-2. Blocking the Patient End of a Single-Limb Circuit
Circuit Check Test
5.
Activate the circuit test by pressing the ENTER key.
6.
During the circuit check (which typically takes about 10 seconds to complete), the ventilator will do the following: a.
b.
c.
Sound a short beep close the exhalation valve
display Test Status as RUNNING (see
Figure F-3. Circuit Check (Running)
Clinician's Manual f.
g.
d.
e.
h.
increase pressure to 30 mbar (± 10% with no leak) display flow sensor measurement as Leak in Lpm (updated every two seconds) sound a short beep every time the flow measurement is updated sound a long audible beep once the check is complete display PASS or FAIL in the Test Status field.
F-3
Alarms Tests
Figure F-4. Circuit Check (Complete, Passed)
Figure F-5. Circuit Check (Complete, Failed)
F-4
7.
Review the results. A FAIL result indicates leak(s) of greater than 1 L/min exist.
To rerun circuit check test, press the ENTER key again. To cancel the circuit check while it is running, press the UP, DOWN, ENTER, VENTILATION ON/OFF, or MENU key.
F.2.2
Troubleshooting a Failed Check
If the circuit check fails, do the following:
1.
Ensure an approved circuit is in use. Reference
.
2.
Check patient circuit connections to the ventilator, examining each for leakage and tightness.
3.
Replace the patient circuit if necessary.
4.
Rerun the circuit check test.
5.
If the failure persists, have the ventilator evaluated by a qualified technician.
Clinician's Manual
Apnea Test
F.3
Apnea Test
Apnea breaths only apply in PSV, CPAP and SIMV modes.
1.
Connect the patient end of the patient circuit to a test lung.
2.
Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on
both the ventilator and the proximal pressure port (see section
” on page
3.
Press the VENTILATION ON/OFF key to start ventilation.
The ventilator will deliver a mandatory breath. Before the second mandatory breath is delivered, verify that the following events occur:
•
•
• the Medium priority indicator (yellow color) illuminates the “APNEA“ alarm is displayed an audible alarm sounds
4.
Press the ALARM CONTROL key twice to reset the alarm.
5.
Press and hold the VENTILATION ON/OFF key for three (3) seconds, then release it. Press the VEN-
TILATION ON/OFF key again to confirm stop.
•
Ventilation stops.
F.4
Power Failure Test
Note:
If the ventilator is operating on either the external power supply or the internal battery, you must plug it in to an AC power source before beginning this test.
Disconnect the ventilator from its AC power supply. Ensure that the following events occur:
1.
•
•
•
• the Medium priority indicator (yellow color) illuminates the “AC POWER DISCONNECTION“ alarm activates an audible alarm sounds the DC POWER indicator illuminates if the DC power source is connected; otherwise, the INTERNAL
BATTERY indicator illuminates
2.
Press the ALARM CONTROL key twice to reset the alarm.
3.
Reconnect the ventilator to its AC power supply.
Clinician's Manual F-5
Alarms Tests
F.5
Occlusion Test
Note:
Occlusion testing can only be done in Pressure modes.
When using a single-limb circuit, do the following:
1.
2.
Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on both the ventilator and the proximal pressure port (see section
, “
).
3.
Block the exhalation port on the exhalation valve of the patient circuit. See
Figure F-6. Blocking the Patient End of a Single-Limb Circuit
F-6
4.
Press the VENTILATION ON/OFF key to start ventilation.
5.
Allow the ventilator to deliver three (3) consecutive breaths. At the beginning of the fourth breath, ensure that the following events occur:
•
•
• the High priority indicator (red color) illuminates the “Occlusion“ alarm activates an audible alarm sounds
6.
Press the ALARM CONTROL
7.
Unblock the exhalation port.
•
The alarm is canceled.
key to pause the audible alarm.
8.
Press and hold the VENTILATION ON/OFF key for three (3) seconds, then release it. Press the VEN-
TILATION ON/OFF key again to confirm stop.
•
Ventilation stops.
Clinician's Manual
High Pressure Test
F.6
High Pressure Test
1.
Set the ventilator to V A/C mode and set the following parameter values:
•
•
Vt: 250 ml
PEEP: OFF
•
•
•
•
Flow Pattern: D
R-Rate: 30 bpm
I:E: 1/4 or I/T: 20%
Insp Sens: 3
•
•
High Pressure Alarm: 12 mbar
Low Pressure Limit must be 4 or lower
2.
Connect the patient end of the patient circuit to a Maquet™* test lung.
3.
Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on
both the ventilator and the proximal pressure port (see section
” on page
4.
Press the VENTILATION ON/OFF key to start ventilation.
5.
Allow the ventilator to deliver three (3) consecutive breaths. At the beginning of the fourth breath, ensure that:
•
•
• the High priority indicator (red color) illuminates the HIGH PRESSURE ALARM activates.
an audible alarm sounds
6.
Press the ALARM CONTROL key once to pause the audible alarm.
7.
Set the High Pressure parameter value to 40 mbar.
•
The alarm is canceled.
8.
Press and hold the VENTILATION ON/OFF key for three (3) seconds, then release it. Press the VEN-
TILATION ON/OFF key again to confirm stop.
•
Ventilation stops.
Clinician's Manual F-7
Alarms Tests
F.7
Battery Test
The ventilator is capable of testing the power of the battery (see Chapter
”). You can determine which power source the ventilator is using by checking the power indicator, located on the top panel. The indicator light will be lit to indicate which power source is currently available.
1.
Disconnect the AC power supply cable and the DC power cable (if it is connected) from the ventilator.
• a POWER DISCONNECTION alarm will trigger.
2.
Press the ALARM CONTROL occur:
•
key twice to pause the alarm. Ensure that the following events the INTERNAL BATTERY indicator to the upper-left of the display illuminates
• the BATTERY symbol is displayed at the top of the screen (along with its reserve capacity)
3.
Connect the AC (mains) power supply. Ensure that the following events occur:
•
• the AC POWER indicator to the upper-left of the display illuminates the indicator to the upper-left of the display is flashing, which indicates that the battery is charging
(this only occurs if the ventilator has run on battery power long enough to lose enough charge that the charger will turn on)
• the BATTERY is no longer displayed at the top of the screen
F.8
Involuntary Stop Test
To verify proper functioning of the Very High Priority audible alarm, perform the following.
1.
Press the VENTILATION ON/OFF key to start ventilation.
2.
Set the I/O switch to the O (off) position to power-down the ventilator during ventilation. Ensure that the following events occur:
•
•
An audible alarm sounds continuously.
The ventilator turns off. There should be no alarm indicators illuminated and no alarm messages displayed.
3.
Press the ALARM CONTROL key once to pause the audible alarm.
F-8 Clinician's Manual
G Unpacking and Preparation
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.
WARNING:
To minimize the risk of damage, you must use the Dual Bag to transport the Puritan Bennett 560
To unpack and prepare the ventilator, follow the steps below.
1.
From the plastic bag, remove the following:
•
•
•
•
Plastic pocket containing the Clinician’s Manual.
The ventilator and its components and/or accessories.
2.
Remove the patient circuit, the AC (“Mains”) power cable, and the set of fine-particle air inlet filters.
3.
Inspect the ventilator and ensure that:
• the ventilator’s outer casing and the I/O switch’s protective cover do not have any dents or scratches, which may indicate possible damage the ventilator’s labels and markings are clear and legible.
the AC power cable does not exhibit any signs of damage, such as kinks, breaks, or cuts.
G-1
Unpacking and Preparation
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 (see Chapter
, “
5.
Ensure that the air inlet filter is installed.
Figure G-1. Puritan Bennett™ 560 Ventilator
G-2 Clinician's Manual
Figure G-2. Dual Bag
Clinician's Manual G-3
Unpacking and Preparation
Page Left Intentionally Blank
G-4 Clinician's Manual
H Parts and Accessories
provides a list of accessories that are available for the Puritan Bennett™ 560 Ventila-
tor.
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 O
2
connector; and one AC power cable.
Description
Carrying bag (grey)
Oxygen inlet connector
Table H-1. List of Consumables and Accessories
Ventilator Cart
Dual Bag (blue or pink) delivered with:
Backpack Padded Straps, 2 ea.
Suspension belt
Carrying belt
WARNING:
To minimize the risk of damage, you must use the ventilator’s Dual Bag to
on page
.
AC (mains) power cable
DC power cable (for connection to an external DC power source, such as a car 12 volt DC outlet)
Nurse call cable (5 meters)
Exhalation block, single-patient use (blue)
H-1
Parts and Accessories
Table H-1. List of Consumables and Accessories (Continued)
Description
Inlet air combi-filter, fine (pack of 6)
Note:
This is the “foam plus fine particle” filter listed in
,
Internal battery
External battery
FiO
2
measurement kit
FiO
2
sensor
2-way and 3-way DAR™ valves
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)
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
” and Appendix
.” The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 1.1 meters (3.6 ft) to 2.0 meters (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.
H-2 Clinician's Manual
Table H-2. List of Circuits
Description
DAR™ Double-limb patient circuit with exhalation valve,
180 cm, PVC, ADULT
Part Number
5094000
DAR™ Double-limb patient circuit with exhalation valve,
180 cm, PVC, PEDIATRIC
5093900
DAR™ Single-limb patient circuit with exhalation valve, 180 cm, PVC, ADULT
5093600
DAR™ Single-limb patient circuit with exhalation valve, 180 cm, PVC, PEDIATRIC
5093500
DAR™ Single-limb patient circuit without exhalation valve,
180 cm, PVC, ADULT
5093300
DAR™ Single-limb patient circuit without exhalation valve,
180 cm, PVC, PEDIATRIC
5093100
For more information regarding parts and accessories for the Puritan Bennett™ 560 Ventilator contact your service representative or http://www.covidien.com/rms/products.
Clinician's Manual H-3
Parts and Accessories
Page Left Intentionally Blank
H-4 Clinician's Manual
I Glossary
AC Power
Alternating current.
Alarm Pause
The audible and visual alarms cease and the symbol appears. The symbol will remain until the cause of the alarm is addressed. For example, when the ventilator is running on internal battery, the AC Disconnection alarm may be paused, and the alarm paused symbol will appear until the device is plugged into AC. The paused alarm will be captured in the alarm log screen and can be reactivated.
Alarm Reset
Used only for the High Pressure alarm, this function resets the visual alarm message.
Apnea
The absence of breathing or a breathing pattern capable of supporting an individual's respiratory needs.
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 SEN-
SITIVITY 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.
I-1
Glossary
Back Up Rate
Rate of control cycles in PSV or SIMV modes during apnea phase.
Battery Level
Display of the remaining battery capacity; located adjacent to the battery symbol.
Bias flow
Turbine flow during exhalation phase through the patient circuit to avoid rebreathing.
bpm
An abbreviation for “breaths per minute,” which is the unit of measure for breath rate (see below).
Breath Rate
The total number of breaths, both machine and spontaneous, delivered by a ventilator in one minute.
Caregiver
An individual who assists a patient with the tasks of daily living. This may be a family member, a live-in assistant, or the nursing staff of a health care facility.
cmH
2
O
An abbreviation for “centimeters of water,” which is a unit of measure for pressure.
CPAP (Continuous Positive Airway Pressure)
Continuous airway pressure maintained throughout a spontaneous breath cycle.
Controlled breath
A volume or pressure breath triggered, controlled and terminated by the ventilator.
DC Power
Direct current.
Double-Limb Patient Circuit
Patient circuit with a tube between the ventilator gas outlet and the patient for inspiratory gas and another tube between the patient and the exhalation block for exhalation gas.
Exhalation Block
Part of the ventilator that allows the connection of the exhalation limb of the patient circuit. The exhalation block is for single-patient use only.
Exhalation Phase
Phase of the breath cycle during which the patient exhales.
Exhaled Tidal Volume (VTE)
Exhaled volume measured for all breath types through the exhalation block. Monitored value available only with double-limb patient circuit.
I-2 Clinician's Manual
Exhalation Sensitivity
The exhalation sensitivity (E Sens) level is a percentage of peak flow at which a pressure-supported breath will be terminated.
Exhalation Tidal Volume (VTE)
Volume exhaled by the patient at each exhalation phase.
Fraction of Inspired Oxygen (FiO
2
)
Amount of oxygen delivered to the patient.
FiO
2
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 liters per minute (lpm).
Flow Pattern (Ramp Setting)
This is the flow distribution shape during the inspiration phase. There are three flow patterns available: Square waveform or constant flow, Decelerated (sawtooth waveform) or decreasing flow and Sinusoidal flow.
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.
Inspiratory Pressure (Pi)
The operator-set inspiratory pressure during a pressure control (PC) mandatory breath.
Inspiratory Sensitivity (I Sens)
Level of inspiratory effort the patient has to provide during the initiation of a machine breath. The sensitivity levels (from 0P to 5) correspond to differences in flow compared to the bias flow. Level
0P is the most sensitive (for a pediatric use) and requires the least effort to trigger a breath. Level
5 requires the most amount of effort to trigger a breath.
Inspiratory Tidal Volume (VTI)
Volume delivered to the patient at each inspiratory phase.
Clinician's Manual I-3
Glossary
I Time (Inspiratory Time)
Inspiratory time measure.
Intentional Vent Stop Alarm
Intentional Ventilation Stop Alarm – Ventilation has been switched off by the user / caregiver and the ventilator is in stand-by.
I/T Ratio
Inspiratory time versus total breath time ratio.
L
liters (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
Liters Per Minute (a unit of volume flow rate).
Machine Hours
Counter for the total ventilation time since manufacture or the last CPU board change.
Mains
AC power supply.
Max Leak
The maximum alarm setting of a high leakage threshold. An alarm will be triggered in the event the calculated leakage flow exceeds this limit.
Max Rtot (Total breath rate)
The maximum alarm setting to prevent hyperventilation or ventilator autotriggering. The HIGH
RATE alarm will be triggered if the total breath rate exceeds the maximum limit set.
Max P (Maximum Inspiration Pressure)
Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the target tidal volume (Vt Target).
Mbar
An abbreviation for “millibar“ which is a unit of measure for atmospheric pressure.
Mean Airway Pressure
Average patient pressure during each breath.
I-4 Clinician's Manual
Minimum Exhalation Time
Minimum exhalation time before allowing the patient inspiratory trigger.
Minimum Inspiratory Time
Minimum inspiratory time before allowing the patient to exhale.
M Vol (Minute Volume)
Flow delivered at each breath to the patient is measured by the inspiratory flow sensor and that measurement is used to calculate minute volume (Vt x Rtot)
P A/C (Pressure Assist /Control)
A ventilator mode which provides machine-initiated breaths delivered at a clinician-set pressure, inspiratory time, and rate.
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.
Paw (Peak Airway Pressure)
The Peak Airway Pressure is the average peak pressure during the inspiratory phase, measured by each cycle and over the previous 24 hour period.
Peak Inspiratory Pressure (PIP)
The highest pressure measured in the patient circuit during the inspiration phase.
Positive End Expiratory Pressure (PEEP)
Pressure in the patient circuit at the end of expiration.
Pressure Control (P Control)
Augmentation of the patient's ventilation synchronously with inspiratory effort until a preset pressure is met. Pressure is maintained throughout patient inspiratory flow, and is cycled to expiration by time (controlled by the selected Inspiratory Time setting). Used in Assist/Control mode.
Pressure Support (P Support)
Augmentation of the patient’s ventilation synchronously with inspiratory effort until a preset pressure is met. Pressure is maintained until inspiratory flow is reduced to a percentage of peak flow
Clinician's Manual I-5
Glossary
I-6 that depends on the exhalation sensitivity setting for the inspiration, when the ventilator cycles into exhalation. Available in SIMV mode.
PSI
Pounds Per Square Inch.
PSV (Pressure Support Ventilation)
Pressure support ventilation.
Rebreathing
The patient breathes his/her exhaled gas.
Respiratory 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 NELL-1 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.
Spont Cyc (Spontaneous Cycling)
This is the percentage of ventilation cycles initiated by the patient over the previous 24 hour period.
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.
SIMV (Synchronized Intermittent Mandatory Ventilation)
A ventilator mode which provides a mechanism for synchronizing the ventilator-delivered breaths with a patient's inspiration, as detected by the ventilator.
Tidal volume (Vt)
Volume of gas delivered to the patient in a breath.
Clinician's Manual
Unfreeze
Resumption of the waveform plot tracing on the ventilator’s display.
V A/C (Volume Assist / Control)
A ventilator mode which provides machine-initiated breaths are delivered at a clinician-set volume inspiratory time, and rate.
Vent Time (Ventilation Time)
The ventilation duration data is based on the patient counter and shows the total ventilation time in hours and minutes over the previous 24 hour period.
Volume breath
Inspiration of the selected volume, delivered over the selected inspiratory time.
Clinician's Manual I-7
Glossary
Page Left Intentionally Blank
I-8 Clinician's Manual
Index
A
AC power
AC power cable
AC POWER DISCONNECTION alarm message . . . . . . . . . . . . . . 5-9, 5-15
Accessories
Air outlet (antibacterial) filter
Air transport
Air transportation standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-16
rules for carry on baggage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
use on commercial aircraft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Alarm Logs menu
Alarm messages
AC POWER DISCONNECTION . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9, 5-15
BATTERY FAULT1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9, 5-16, 8-4
BATTERY FAULT2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9, 5-16
BUZZER LOW BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9, 5-16
CALIBRATE FIO
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
CALIBRATION FAIL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-17, 10-4
CHECK BATTERY CHARGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK EXH VALVE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK EXH VALVE PRESSURE . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK FIO
SENSOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK PROXIMAL LINE1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK REMOTE ALARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-18
CHECK SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-18
CONNECT VALVE OR CHANGE PRESS . . . . . . . . . . . . . . . . . . 5-10, 5-18
CONTROLLED CYCLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-18
COOLING FAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-18
DC POWER DISCONNECTION . . . . . . . . . . . . . . . . . . . . .5-11, 5-18, 6-8
DEVICE FAULT10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
DEVICE FAULT12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
DEVICE FAULT13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
DEVICE FAULT3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
E SENS FAULT OR CIRC LEAK . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
EMPTY BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11, 5-19, 8-4
EXH VALVE LEAKAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
FIO
SENSOR MISSING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
HIGH FIO
2
HIGH INT TEMP COOL VENT . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-20
HIGH LEAKAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-21
HIGH PRESSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
HIGH/LOW BATTERY TEMP . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-21
INTENTIONAL VENT STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
KEYPAD FAULT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
LOW BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7, 5-13, 5-23, 8-4
LOW FIO
NO PROXIMAL LINE2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-25
OCCLUSION CHECK CIRCUIT . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-25
PATIENT DISCONNECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-25
POWER FAULT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
POWER SUPPLY LOSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
PRES SENS FLT1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
PROX SENS FLT2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
REMOVE VALVE CPAP MODE . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
REMOVE VALVE OR CHANGE PRES . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
SOFTWARE VERSION ERROR . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
TURB OVERHEAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
UNKNOWN BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
VALVE MISSING CONNECT VALVE . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
VTI NOT REACHED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
Alarm parameters
V SIMV Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Alarm parameters
P A/C Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
P SIMV Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
V A/C Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Alarm tests
Alarm thresholds
and linked Ventilation parameters . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28
Alarms
thresholds, blocking when linked to a ventilation parameter . 7-30
Alarms and troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarms tests
IN-1
Altitude compensation feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Apnea
and Backup Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29, 3-31
and ventilation modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
APNEA alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
Apnea Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6, 3-10, 3-24, 3-30
Audible alarms
B
Backlight, display
Backup Rate
and R-Rate setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28, 3-29, 3-30
Battery
BATTERY FAULT1 alarm message . . . . . . . . . . . . . . . . . . . . . 5-9, 5-16, 8-4
BATTERY FAULT2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
Battery, internal
indicator, front panel (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Blocking an alarm threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30
BUZZER FAULT1 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
BUZZER FAULT2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
BUZZER FAULT3 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
BUZZER LOW BATTERY alarm message . . . . . . . . . . . . . . . . . . . .5-9, 5-16
C
CALIBRATE FIO
2
alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9, 5-16
Calibrating
Calibrating the FIO
sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
CALIBRATION FAIL alarm message . . . . . . . . . . . . . . . . . . . 5-9, 5-17, 10-4
Carbon dioxide
risk of inhalation and suffocation . . . . . . . . . . . . . . . . . . . . . . .1-2, 7-39
Carrying bag, ventilator (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .G-2
Changing ventilation modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
CHECK BATTERY CHARGE alarm message . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK EXH VALVE alarm message . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK EXH VALVE PRESSURE alarm message . . . . . . . . . . . . . 5-10, 5-17
CHECK FIO
2
SENSOR alarm message . . . . . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK PROXIMAL LINE1 alarm message . . . . . . . . . . . . . . . . . 5-10, 5-17
CHECK REMOTE ALARM alarm message . . . . . . . . . . . . . . . . . . 5-10, 5-18
CHECK SETTINGS alarm message . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-18
troubleshooting a failed check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F-4
Cleaning
solutions and products, approved . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2
Clinician
CONNECT VALVE OR CHANGE PRESS alarm message . . . . . . 5-10, 5-18
Connecting to
oxygen supply (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Consumables
replacement intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Contraindications
CONTROLLED CYCLES alarm message . . . . . . . . . . . . . . . . . . . 5-10, 5-18
COOLING FAN alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-18
D
DC power cable
connecting to ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7
disconnecting from ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8
DC POWER DISCONNECTION alarm message . . . . . . . . .5-11, 5-18, 6-8
DEVICE FAULT10 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT11 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
DEVICE FAULT12 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
DEVICE FAULT13 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
DEVICE FAULT3 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT5 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT7 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
DEVICE FAULT9 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-18
Display
showing waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Display Waveforms parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
IN-2
Index
Displayed parameters
E
E SENS FAULT OR CIRC LEAK alarm message . . . . . . . . . . . . . . . . . . . 5-11
Electromagnetic compatibility
and mobile/portable communications equipment . . . . . . . . . . . .6-2
Electromagnetic emissions
EMPTY BATTERY alarm message . . . . . . . . . . . . . . . . . . . . .5-11, 5-19, 8-4
Environment
suitable for use of ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8
Erase Data, USB Memory Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-36
EXH VALVE LEAKAGE alarm message . . . . . . . . . . . . . . . . . . . . . 5-11, 5-19
Exhalation flow sensor
F
FIO
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8, 3-11, 3-16, 3-21, 3-26, 3-33
oxygen and ventilator settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
FIO
2
sensor
FIO
2
SENSOR MISSING alarm message . . . . . . . . . . . . . . . . . . . 5-11, 5-19
Fraction of Inspired Oxygen . . . . . . . . 3-8, 3-11, 3-16, 3-21, 3-26, 3-33
Freeze function
Freezing a waveform trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
G
Gas delivery system (diagram) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
H
Heat safety device, battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7, 6-2
HIGH FIO
alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11, 5-20
HIGH INT TEMP COOL VENT alarm message . . . . . . . . . . . . . . 5-12, 5-20
HIGH LEAKAGE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-21
HIGH PRESSURE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
HIGH RATE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
HIGH VTE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-22
HIGH VTI alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-22
HIGH/LOW BATTERY TEMP alarm message . . . . . . . . . . . . . . . 5-11, 5-21
Hot surfaces
I
Indicator
Indicator and alarm specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
Indicators
INTERNAL BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3, 8-5
Inhalation port closeup (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
INSP FLOW alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
Inspiratory Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14, 3-19, 3-23
INTENTIONAL VENT STOP alarm message . . . . . . . . . . . . . . . . 5-12, 5-23
Internal battery
maintenance (none required) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
replacement interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9, 10-10
INTERNAL BATTERY indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
K
Key sound
KEYPAD FAULT alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12, 5-23
Keys
VENTILATION ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
L
Linked ventilation parameters
Liquids
avoid ingress into ventilator (Warning) . . . . . . . . . . . . . . . . . . . . . . . 1-4
Locking key
Locking Key and SETUP menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Logs menu
IN-3
LOW BATTERY alarm message . . . . . . . . . . . . . . . . . . 1-7, 5-13, 5-23, 8-4
LOW FIO
alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-24
LOW VTE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-24
LOW VTl alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13, 5-24
M
Maintenance
option
reserved for service personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
schedule, recommended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Manufacturer’s declaration specifications . . . . . . . . . . . . . . . . . . . . . .B-10
Max P (Maximum inspiration pressure) . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Max Rtot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8, 3-10, 3-16, 3-26, 3-33
Maximum inspiration pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Menu
Preferences, parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Modes ventilation
Monitored parameters
Waveform menu (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
N
NO DATA message, Alarm Logs screen . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
NO PROXIMAL LINE2 alarm message . . . . . . . . . . . . . . . . . . . . 5-13, 5-25
Notes
Nurse call system
connecting the cable to the ventilator . . . . . . . . . . . . . . . . . . . . . .6-26
O
OCCLUSION CHECK CIRCUIT alarm message . . . . . . . . . . . . . 5-13, 5-25
OCCULSION CHECK CIRCUIT alarm message . . . . . . . . . . . . . . . . . . . 5-25
Operational verification checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Operator/Users
targeted for use of ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
O-ring, oxygen coupler (Caution) . . . . . . . . . . . . . . . . . . . . . . . 1-18, 6-21
Oxygen
connecting the supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
disconnecting the supply from the ventilator . . . . . . . . . . . . . . . 6-22
rear panel connector (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
special coupler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18, 6-20, 6-21
using medical-grade only (Warning) . . . . . . . . . . . . . . . . . . 1-17, 6-20
P
P A/C Mode Menu
P SIMV Mode Menu
Parameter values
Parameters
ventilation
Parameters, operating
Fraction of Inspired Oxygen (FIO
2
) . . . . . . . . . . . . . . . . . . . . . . . 3-11
Inspiratory Tidal Volume (VTI) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Inspiratory Trigger Sensitivity (I Sens) . . . . . . . . . . . . . . . . . . . . 3-11
Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . 3-10
Expired Tidal Volume (VTE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Fraction of Inspired Oxygen (FIO
2
) . . . . . . . . . . . . . . . . . . . . . . . 3-16
I Sens (Inspiratory Sensitivity) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Inspiratory Tidal Volume (VTI) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Max Rtot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-20, 3-33
Peak inspiratory pressure (PIP) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . 3-13
Respiratory Rate (Rate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
P A/C mode Max P (Maximum inspiration pressure) . . . . . . . . . 3-15
E Sens
Expired Tidal Volume (VTE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Fraction of Inspired Oxygen (FIO
2
) . . . . . . . . . . . . . . . . . . . . . . . 3-26
I Sens (Inspiratory Sensitivity) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Inspiratory Tidal Volume (VTI) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Inspiratory Time (Insp Time) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . 3-23
Pressure Support (P support) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Respiratory rate (Rate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Expired Tidal Volume (VTE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Fraction of Inspired Oxygen (FIO
2
) . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Inspiratory Tidal Volume (VTI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Inspiratory Trigger Sensitivity (I Sens) . . . . . . . . . . . . . . . . . . . . . .3-4
Min/Max Inspiration Time (Min I Time/Max I Time) . . . . . . . . . .3-6
Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . . .3-3
IN-4
Index
Pressure Support (P Support) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
PSV mode Exhalation sensitivity (E Sens)
Exhalation Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Expired Tidal Volume Control (VTE) . . . . . . . . . . . . . . . . . . . . . . 3-20
Flow Shape (Ramp) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Fraction of Inspired Oxygen (FIO
2
) . . . . . . . . . . . . . . . . . . . . . . . 3-21
I Sens (Inspiratory Sensitivity) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Peak Inspiratory Pressure (PIP) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . 3-18
Volume Control (Vt) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
E Sens
Expired Tidal Volume (VTE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Fraction of Inspired Oxygen (FIO
2
) . . . . . . . . . . . . . . . . . . . . . . . 3-33
I Sens
Inspiratory Tidal Volume (VTI) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Inspiratory Time (Insp Time) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Peak Inspiratory Pressure (PIP) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Positive End Expiratory Pressure (PEEP) . . . . . . . . . . . . . . . . . . 3-29
Pressure Support (P support) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Volume Control (Vt) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Patient
outlet port connections (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
double limb, connecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
length and internal volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
single limb, connecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
PATIENT DISCONNECTION alarm message . . . . . . . . . . . . . . . . 5-13, 5-25
Patient hours
changing the setting of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7
Patients
targeted for use of ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3, 3-10, 3-13, 3-18, 3-23, 3-29
Performance specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
Positive end expiratory pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
POWER FAULT alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
POWER SUPPLY LOSS alarm message . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
Precautions for use
electromagnetic interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Precautions for use, cautions
installation
Precautions for use, warnings installation
electrical power supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Preference menu
changing the settings in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
PRES SENS FLT1 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
PROX SENS FLT2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-25
PSV Mode Menu
R
Range, resolution, and accuracy specifications . . . . . . . . . . . . . . . . . . B-5
Recharging the internal battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
REMOVE VALVE CPAP MODE alarm message . . . . . . . . . . . . . 5-14, 5-25
REMOVE VALVE OR CHANGE PRES alarm message . . . . . . . . 5-14, 5-25
Repairing the ventilator
qualified personnel only (Warning) . . . . . . . . . . . . . . 10-1, 10-7, 10-9
Replacement intervals
Replacing
S
Safety
onboard alarm system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Service assistance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
Setting ventilation parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26
Setup Configuration
SETUP screen
IN-5
SOFTWARE VERSION ERROR alarm message . . . . . . . . . . . . . 5-14, 5-26
Specifications
manufacturer’s declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-10
range, resolution, and accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5
standards compliance and IEC classification . . . . . . . . . . . . . . . . .B-15
Standards, compliance, and IEC classification specifications . . . . .B-15
Stud, oxygen connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18, 6-21
T
Testing
Transfer continuously, USB Memory Device . . . . . . . . . . . . . . . . . . . . 7-32
Transfer Trends USB Memory Device . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Transport, emergency
ventilator not intended for . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Trigger threshold setting
Troubleshooting
TURB OVERHEAT alarm message . . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
U
Unfreeze function
Unfreezing a waveform trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
UNKNOWN BATTERY alarm message . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
Unpacking and preparing the ventilator . . . . . . . . . . . . . . . . . . . . . . . .G-1
USB Memory Device
USB Menu parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31
V
V A/C Mode Menu
V SIMV Mode Menu
VALVE MISSING CONNECT VALVE alarm message . . . . . . . . . 5-14, 5-26
Ventilation
VENTILATION ON/OFF key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Ventilation parameters
setting when linked to alarm thresholds . . . . . . . . . . . . . . . . . . . . 7-28
setting when linked to other parameters . . . . . . . . . . . . . . . . . . . 7-27
Ventilator
connecting the nurse call cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
connections, proper (warning) . . . . . . . . . . . . . . . . . . . . . . 1-5, 6-2, 6-9
mounting on a wheelchair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
operation (description of ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
patient outlet port connections (figure) . . . . . . . . . . . . . . . . . . . . 6-13
potentially hot surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-41
symbols and markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
unpacking and preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1
Ventilator, and liquid ingress (Warning) . . . . . . . . . . . . . . . . . . . . . . . . .1-4
VTI NOT REACHED alarm message . . . . . . . . . . . . . . . . . . . . . . . 5-14, 5-26
W
Warnings
ventilator-dependent patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
Waveform menu
monitored parameters (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Waveforms
Welcome Menu screen
IN-6
Index
Wheelchair
mounting the ventilator onto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
IN-7
Page Left Intentionally Blank
IN-8
Part No. 10071962 Rev C 2015-08
© 2014 Covidien.
Covidien llc
15 Hampshire Street, Mansfield, MA 02048 USA
Covidien Ireland Limited, IDA Business and Technology ParkTullamore.

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Key features
- Portability
- Non-invasive and invasive ventilation
- Variety of modes and breaths
- Pressure support ventilation (PSV)
- Continuous positive airway pressure (CPAP)
- Assist/control (A/C)
- Synchronized intermittent mandatory ventilation (SIMV)
- Built-in battery
- Alarm system
- Data logging