Covidien Puritan Bennett 560 User Manual
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User 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, 2017 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: www.medtronic.com/covidien/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
User Manual iii
iv
User Manual
Table of Contents
User Manual v
vi
Operational Verification Checklist
User Manual
List of Figures
User Manual vii
viii
User Manual
List of Tables
User Manual ix
Page Left Intentionally Blank x
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.
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.
xi
Preface
For online technical support, visit the SolvIT
SM
Center Knowledge
Base by clicking the link at www.medtronic.com/covidien/ support/solvit-center-knowledge-base/. 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
Technical service contacts:
Covidien Australia
52A Huntingwood Drive
Huntingwood, NSW 2148
Australia
Tel: +61 1800 350702
Fax: +612 9671 8118
Covidien Belgie S.A.-N.V.
Generaal De Wittelaan 9/5
Mechelen
2800
België
Tel: +32 220 08260
Fax: +32 270 06690
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 Chile
Lo Boza 107
Pudahuel
Santiago de Chile, Chile
Tel: 562 231 3411
Fax: 562 231 3527
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 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 Danmark A/S
Langebrogade 6E, 4. sal
1411 København K
Danmark
Tel: +45 43 68 21 71
Fax:+45 43 31 48 99
Covidien Austria GmbH
Campus21
Europaring F09402
Brunn am Gebrige
A-2345 Österreich
Tel: +43 1 20609 1143
Fax: +43 1 20609 2457
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 Costa Rica
Global Park, Parkway 50
La Aurora, Heredia, 40104
Costa Rica
Tel: 506 256 1170
Fax: 506 256 1185
Fax: 506 290 8173
Covidien Deutschland GmbH
Technisches Service Center
Raffineriestr. 18
93333 Neustadt / Donau
Germany
Tel: + 49 69 51 709670
Fax: + 49 69 29 9571608 xii User Manual
User Manual
Technical Support
Covidien ECE
Galvaniho 7/a
821 04 Bratislava
Slovenska Republika
Tel: +42 124 821 45 73
Fax: +42 124 821 45 01
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 Italia S.p.A.
Via S.Bovio 3
San Felice, 20090 Segrate (MI) Italy
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 182
Warszawa. 02-222
Polska
Tel: +48 22 279 04 05
Fax: +48 22 279 04 03
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
Technical service contacts:
Covidien Finland Oy
Rahtitie 3
FI-01530 Vantaa
Finland
Tel: +358 9 725 192 88
Fax: +358 9 725 192 89
Covidien Hungary
1095 Budapest
Mariassy u. 7
Magyarorszag
Hungary
Tel: + 36 1880 7975
Fax: + 36 1777 4932
Covidien Russia
53 bld. 5 Dubininskaya Street
Moscow
RUSSIA. 119054 Poccии
Tel: +70 495 933 64 69
Fax: +70 495 933 64 68
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 1 407 3173
Fax: +353 1 907 5668
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: +351 21 761 62 44
Fax: +351 800 781385
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
xiii
Preface
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 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: 656578 5187 / 8 / 9
Fax: 65 6515 5260
Email: [email protected]
xiv User 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 1.2, “
Warnings ,” as well as all warnings and cautions contained
throughout this manual.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance contact your clinician or equipment representative.
1.2
Warnings
1.2.1
General Warnings Regarding Use of Equipment
WARNING:
The ventilator must be used only under the responsibility and on the prescription of a doctor.
1-1
1-2
Safety Information
WARNING:
The ventilator must be used according to its intended use. Refer to section
WARNING:
Be aware this material describes how to respond to ventilator, but 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.
User Manual
Warnings
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.
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.
WARNING:
If the ventilator fails the alarm tests or if you cannot complete the tests, refer to Chapter
3 , “ Alarms and Troubleshooting ” 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 7 , “ Cleaning
. “
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.
User Manual 1-3
1-4
Safety Information
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
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.
User Manual
Warnings
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.
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:
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 (
68°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.
User Manual 1-5
1-6
Safety Information
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 8 ,
“ Routine Maintenance ”). This is particularly important when the ventilator is installed on a
wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
WARNING:
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 4.2
, “
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
User Manual
Warnings inscribed on the rear of the ventilator to ensure correct operation. Refer also to the electrical
specifications found in Appendix A , “ Specifications .”
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.
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 section
, “ 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.
User Manual 1-7
1-8
Safety Information
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.
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 7.3
, “
”). 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.
User Manual
Warnings
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.
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, Table F-2. on page F-2 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.
User Manual 1-9
Safety Information
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.
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
this manual; refer to Chapter 4 , “ Installation and Assembly ” 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 F , “ Parts and Accessories
” or 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.
1-10 User Manual
Warnings
WARNING:
Before using the Nurse Call system, ensure that its connections are secure and it operates properly.
For more information, contact Covidien or your equipment supplier.
WARNING:
To connect the ventilator to a Nurse Call device, contact Covidien or your equipment supplier 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.
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.
User Manual 1-11
Safety Information
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.
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 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 to ensure the Min 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.
1-12 User Manual
Warnings
WARNING:
Adjustable alarms should not be systematically canceled; instead, they should be adjusted according to the needs and condition of the patient.
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.
User Manual 1-13
Safety Information
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.
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.
1-14 User Manual
Warnings
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.
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 7.3
, “
”). 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.
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 ventilator) and Chapter 4 , “ Installation and Assembly .”
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 7 , “ Cleaning
.”
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 8
,
“ Routine Maintenance ”). This is particularly important when the ventilator is installed on a
wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
WARNING:
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
User Manual 1-15
Safety Information 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 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:
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.
1-16 User Manual
Warnings
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.
WARNING:
Strictly follow the instructions provided in section 4.8.2
, “ Connecting the Oxygen Supply
,” 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
A-3 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.
User Manual 1-17
Safety Information
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.
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.
1-18 User Manual
Symbols and Markings
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
“ Specifications .” In particular, the use of nearby mobile and portable communications equipment
using radio frequencies, such as mobile telephones or other systems exceeding the levels set in
the IEC 60601-1-2 standard, may affect its operation. Refer to section A.10
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.
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
item 9.
Alternating current, AC (IEC 60417-5032).
This symbol appears on the ventilator’s back panel and keyboard; see Figure 1-4. , item 8, and
Figure 2-2. on page 2-5 , item 10.
Internal battery.
This symbol appears on the ventilator’s keyboard; see Figure 2-3. on page 2-6
, item 10.
Insulation class II equipment (IEC 60417-5172).
A regulatory standard classification for protection against electric shock. Class II equipment relies on double insulation rather than protective earthing.
This symbol appears on the ventilator’s back panel; see
, item 5.
User Manual 1-19
Safety Information
Symbols
Table 1-1. Ventilator Symbols
Descriptions
Index of Protection rating for the ventilator’s enclosure, defined in IEC 60529 (BSEN60529:1991).
The first digit, 3, indicates protection against the intrusion of small foreign bodies (including fingers, tools, wires, etc. with a diameter greater than 2.5 mm) into the ventilator. The second digit, 1, indicates protection against water dripping or falling vertically, as well as an environment featuring water vapor condensation and/or light rain.
This rating appears on the ventilator’s back panel; see
CSA—Canadian Standards Association.
This symbol appears on the ventilator’s back panel; see
CE—Conformity European
Signifies compliance with the medical device directive 93/42/EEC as amended by 2007/47/EC.
This symbol appears on the ventilator’s back panel; see
This key is used to: move the LCD display’s cursor upwards, line-by-line; increase the value of displayed and selected parameter settings; restart (“unfreeze”) waveforms tracing.
This symbol appears on the ventilator’s front panel DOWN/FREEZE key; see
, item 6.
This key is used to: move the LCD display’s cursor downwards, line-by-line; decrease the value of displayed and selected parameter settings; stop (“freeze”) waveforms tracing.
This symbol appears on the ventilator’s front panel ENTER key; see Figure 2-3. on page 2-6 , item 5.
This key is used to confirm command actions.
This key is used to: cancel the audible portion of alarms for 60 seconds at a time; cancel an alarm.
For more information, see Appendix E , “ Alarms Tests .”
This symbol appears on the ventilator’s front panel MENU key; see Figure 2-2. on page 2-5 , item 7.
This key is used to access the ventilator’s menus via the ventilator’s front panel LCD display.
This symbol (IEC 60417– 5009) appears on the ventilator’s front panel VENTILATION ON/OFF button; see
, item 8.
This key is used to start and stop ventilation.
To patient port.
, 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
4.
Patient proximal pressure port.
and
1-20 User Manual
User Manual
Symbols
Symbols and Markings
Table 1-1. Ventilator Symbols
Descriptions
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
, and
, item 3.
Oxygen inlet.
item 2.
Nurse call connector.
This symbol appears on the back panel of the ventilator, adjacent to the nurse call connector; see
Switch in “Off” position (IEC 60417-5008).
This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator to indicate the switch’s “Off” position. See
Figure 2-2. on page 2-5 , item 2.
Switch in “On” position (IEC 60417-5007).
This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator to indicate the switch’s “On” position. See
, item 2.
Software lock enabled.
This symbol appears on the upper-left of the ventilator’s LCD display when the keyboard Locking key is enabled.
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
, item 1 and Chapter
, “
”, for more information.
Pressure rise times (inspiratory phase) parameter.
These symbols appear on the ventilation mode menu screens. In pressure ventilation modes, you can select one of four rise times with setting 1 representing the fastest rise time and setting 4 representing the slowest.
Flow shape (“flow distribution shape”, inspiratory phase) parameter.
These symbols appear on the ventilation mode menu screens; selectable for V A/C mode only. For more
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.
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).
1-21
Safety Information
Symbols
Table 1-1. Ventilator Symbols
Descriptions
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.
WEEE (Waste Electrical and Electronic Equipment).
This symbol means that this product must not be disposed of with household waste. Observe local ordinanc-
es for proper disposal. See Table 1-2.
, item 5.
Year of manufacture.
Manufacturer.
Audio Paused (alarm key once).
This symbol means the sounding of audible alarms is currently disabled.This period lasts 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 Preferences 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.”
1-22 User Manual
User Manual
Symbols
Symbols and Markings
Table 1-1. Ventilator Symbols
Descriptions
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.
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
Atmospheric pressure limitation.
Humidity limitations.
Temperature limitations.
Fragile
Keep dry.
Keep away from direct sunlight.
This side up.
1-23
Safety Information
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. to locate the labels in
Table 1-2. Ventilator Labels and Markings
1. Patient gas inlet label
(
2. Oxygen inlet marking and label (
)
3. Exhalation valve and patient pressure connection label (
4. From patient port, exhalation limb connection of patient circuit—single use exhalation block label
(
5. Air inlet label (
6. Exhaled gas outlet label
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
1-24 User Manual
Labels/Identification and Instruction Information
Table 1-2. Ventilator Labels and Markings (Continued)
10. PC connection marking
(
N/A
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
Figure 1-1. Locations of Labels—Top-Front View
User Manual 1-25
Safety Information
Figure 1-2. Locations of Labels—Front-Left View
Figure 1-3. Location of Labels and Markings—Rear View
1-26 User Manual
Labels/Identification and Instruction Information
Figure 1-4. Location of Labels—Bottom View
User Manual 1-27
Safety Information
Page Left Intentionally Blank
1-28 User 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 Appendix
, “ Standards Compliance and IEC Classification .” Patients traveling with
the Puritan Bennett 560 Ventilator may be required by their airline to demonstrate evidence of compliance with the RTCA/DO-160F standard, as well as other requirements. Contact your airline prior to travel to determine airline specific requirements and documentation.
WARNING:
Even though the Puritan Bennett™ 560 Ventilator meets current safety standards, the internal
Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the
Puritan Bennett™ 560 Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA:
International Air Transport Association), International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by
Road (ADR) for Europe. Private individuals who transport the device are excluded from these
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 the following caregivers:
Respiratory therapists
Doctors
Nurses
Homecare providers
• Patient and patient’s families
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 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 or 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)
Pressure Support Ventilation with apnea ventilation (PSV/ST)
User Manual
Device Classification
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 3 , “ Alarms and Troubleshooting .”
Settings
A software key, known as the Locking key, restricts access to ventilation parameter settings and ventilation mode changes in order to distinguish between clinician usage and patient usage.
Oxygen Enrichment
Oxygen may be supplied from an external, low pressure source, but the oxygen flow must be limited to 15 lpm (50 kPa, 500 mbar). The ventilator automatically compensates for the extra flow created by the external oxygen supply (see Chapter
4 , “ Installation and Assembly
.”)
Breathing Circuit
The ventilator can be used with a single- or double-limb patient circuit. If exhaled volume monitoring is required (such as ventilator 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
Device name.
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
.”
User Manual 2-3
Ventilator Overview
2.5
Front Panel
Figure 2-1. Front Panel
2-4
1 LCD display —Shows 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 Exhalation valve port —Nipple for providing piloting pressure to the exhalation valve. Controls the openclosed position of the exhalation valve.
2 Control panel —Features the controls for setting up and operating the ventilator, and LEDs to indicate the ventilator's power source, ventilation on/off status, and alarm priority level. Control functions include turning on and off the ventilation, configuring ventilation modes, pausing audible alarms, canceling alarms, and setting device and alarm parameters.
3 FiO
2
sensor connection —Connection for FiO
2 sensor, which monitors the amount of oxygen in the patient circuit.
7 Lateral and front openings— audible alarms.
WARNING:
Vents that allow for air circulation to cool the ventilator’s internal components. In addition, these openings function as sound ports for
Do not cover or obstruct these openings.
8 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
9 Exhaled gas outlet— Exhalation valve connects here.
4 Patient connection port —Provides an outlet for the gas to be delivered to the patient via the patient circuit.
5 Patient pressure monitoring port —Nipple for monitoring proximal patient pressure.
1.
If exhaled tidal volume monitoring is required, use the double-limb circuit.
User Manual
2.6
Back Panel
Figure 2-2. Back Panel
Back Panel
User Manual
1 Ergonomic carrying handle.
2 On/Off (I/O) switch with protective cover:
Device powered on in position I; device switched off in position 0.
3
4
5
AC power (“mains”) cable connector.
AC power (“mains”) cable holding system:
Secures AC power cable to avoid accidental disconnection.
Access cover for the internal battery.
6 DC power cable connector with key.
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 (see
”).
Nurse call output connector:
Used to connect the ventilator to the nurse call system.
10 USB memory device connection:
USB connection to be used with Puritan Bennett Respiratory Insight Software. There are two USB type A ports.
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 the waveform shown 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 menu shown. From the Ventilation menu screen, press this key to show the Alarm menu screen.
When a USB memory device is inserted into the ventilator, press this key to show the USB memory device screen.
3 Display screen:
Shows modes, ventilation settings, patient data and waveforms, configuration of the ventilator, and alarm management.
8 VENTILATION ON/OFF button:
• ON: Press briefly and release to start ventilation.
• OFF: Press and hold for 3 seconds, then press again to stop ventilation.
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.
9 Ventilation status indicator:
• Blue indicator illuminated: Device is turned on and ventilation is off (on standby).
• Blue indicator off: Ventilation is on.
10 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.
User Manual
2.8
Ventilation Menu
Figure 2-4. Ventilation Menu Display
Ventilation Menu
User Manual
Ventilation menu with ventilation on standby.
Ventilation menu during ventilation.
1 General information line:
Shows the current ventilation mode, along with the following:
• Battery symbol if the device is powered by the internal battery.
• Audio paused symbol if an alarm is currently inhibited.
2 Ventilation settings:
Shows the specific ventilation parameter values for the currently selected ventilation mode.
3 Preferences menu access line:
Highlight this line and press the
ENTER key to show the Preferences menu.
• Alarm paused symbol if an alarm has been canceled manually and the cause of the alarm remains.
• Apnea alarm deactivation
• Exhalation valve symbol.
• No exhalation valve symbol.
• Absolute ABS symbol.
• Relative REL symbol.
4 Bargraph:
Shows pressure generation during ventilation.
5 Status/monitored data window:
• Ventilation stopped (standby): shows the message, “PRESS
TO START VENTILATION.”
• Ventilation on: parameters are monitored and shown.
• 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, shows the last alarm along with its trigger date and end-of-event time.
See Chapter
, “
” for details.
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:
Shows ventilation mode and the following symbols:
• Battery symbol if the device is powered by the internal battery.
• Audio paused symbol if an alarm is currently inhibited.
• Alarm paused symbol if an alarm has been canceled manually and the cause of the alarm remains.
2 Alarm settings:
Shows 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 show the Preferences menu.
, “
.”
• Apnea alarm deactivation
• Exhalation valve symbol.
• No exhalation valve symbol.
4 Status/monitored data window:
• Ventilation stopped (standby): shows the message, “PRESS TO START
VENTILATION.”
• Ventilation on: parameters are monitored and shown.
• 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, shows the last alarm along with its trigger date and endof-event time.
See Chapter
3 , “ Alarms and Troubleshooting
” for details.
User Manual
User Manual
Waveforms Menu
2.10
Waveforms Menu
The display of waveforms (
Figure 2-6. ) is optional and can be selected using the Menu
The Waveform menu is only accessible when ventilation is active.
Figure 2-6. Waveforms Menu
key.
1 Title line:
Shows ventilation mode and the following symbols:
2 Graphic zone:
Shows the patient’s pressure and flow waveforms as a function of time.
• Battery symbol if the device is powered by the internal battery.
3 Numeric zone:
Shows monitored data.
• 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
• Exhalation valve symbol.
• No exhalation valve symbol.
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
3 , “ Alarms and Troubleshooting
.”
If you cannot determine the cause of a problem, contact your equipment supplier or Covidien.
See section
, “
2-10 User Manual
3 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.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance contact your Clinician or equipment representative.
Note:
Default alarm setting preferences should be entered prior to using 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
Some of the ventilator alarms are adjustable, depending on ventilation modes. Automatic, nonadjustable alarms also exist to create a safety net for safer patient ventilation.
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 nonvolatile internal memory, and are retained when powering down or in the event of a total loss of power.
3-1
3-2
Alarms and Troubleshooting
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).
3.1
Alarm Level of Priority
•
•
The alarm hierarchy for signaling the level of alarm criticality is listed as follows:
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:
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.
Note:
There are currently no low priority (LP) alarms.
3.2
Alarm Display
•
•
•
During operation, when an alarm is activated, the following events occur:
One of the red or yellow alarm indicators to the left of the ALARM CONTROL and flashes.
key illuminates
An alarm tone sounds.
A message is shown and flashes in reverse video at the bottom of the Ventilation menu or Alarm menu.
User Manual
Alarm Display
Ventilation Menu
1 Alarm Control key
Alarm Menu
1 Alarm messages
Note:
There are currently no low priority (LP) alarms.
Note:
When an alarm is triggered, if the current menu shown is not the Ventilation parameters or Alarm menu, the display automatically switches to one of these menus to show the alarm message.
Note:
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 shown, in the sequence in which they occurred.
User Manual 3-3
Alarms and Troubleshooting
3.3
Alarm Logs Menu
All alarms are recorded in the ventilator’s nonvolatile internal memory at the time of activation and are retained when powering down or in the event of a total loss of power. The Alarm Logs menu is used to show the last eight 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 shown).
2.
Press the DOWN key until the cursor is on the Alarm Logs line at the bottom of the page. The
display appears as shown in Figure 3-1. :
Figure 3-1. Accessing Alarm Logs Menu
3.
Press the ENTER key. The Alarm Logs screen is shown.
Figure 3-2. Alarm Logs Screen
3-4 User Manual
Pausing the Audible Portion of Alarms
Note:
When no alarm has been activated, NO DATA is shown on the screen (see Figure 3-3. ).
Figure 3-3. Alarm Logs Screen when No Alarm Activated
For more information on the User’s clear alerts line, see section 3.6
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.
3.4
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 shown at the top right of the screen while the audio pause function is active.
User Manual 3-5
Alarms and Troubleshooting
Figure 3-4. Pausing the Audible Portion of Alarms
3-6
If several alarms are activated at the same time, pressing the ALARM CONTROL affects all current alarms.
•
The audible portion of activated alarms is automatically reactivated if the following occurs:
After 60 seconds, if the cause or causes of the alarm or alarms persist
• Whenever a new alarm is activated
Note:
If a key is stuck or held down for 45 seconds a keypad alarm will occur.
3.5
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 (for example, HIGH PRESSURE). Some alarms can be paused manually even if the cause or causes of their activation remain.
To manually pause an alarm, proceed as follows:
Press the ALARM CONTROL key twice.
User Manual
Reactivating Alarms
• 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 which can be paused manually).
• The Alarm Paused symbol is shown at the top right of the Ventilation, Alarms, and Waveforms
Figure 3-5. Manually Pausing Alarms
When no other alarms are currently activated, the last alarm canceled is shown 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
, “
.”
To manually reset the High Pressure alarm, proceed as follows:
Press the ALARM CONTROL key twice. The visual alarms will be reset.
3.6
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 shown.
2.
Press the DOWN
See
key to position the cursor on the Alarm Logs line, if this is not already the case.
User Manual 3-7
Alarms and Troubleshooting
Figure 3-6. Reactivating Alarms
3.
Press the ENTER
4.
Press the UP
key, to confirm access to the Alarm Logs menu.
key to position the cursor on the User’s clear alerts line. See
:
Figure 3-7. Alarm Logs
3-8
5.
Press the ENTER
•
•
•
•
key for at least 3 seconds. The following events occur:
A “beep” sounds.
An audible alarm sounds.
An alarm indicator illuminates.
The messages of all active alarms are shown in a loop in the Ventilation and Alarm menus.
• The Audio Paused symbol disappears (if it was shown).
• The Alarm Paused symbol disappears.
User Manual
Overview of Alarms
3.7
Overview of Alarms
Note:
The message: “*IF PERSISTS RESTART/SRVC” will occur only if the alarm condition continues for longer than
30 seconds.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance, contact your clinician or equipment representative.
Table 3-1. Overview of Alarms
Cause/ventilator response Priority Alarm message Audio Paused available
Alarm Paused available
Yes Yes AC POWER
DISCONNECTION
APNEA
BATTERY FAULT1
RESTART/SRVC
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.
MP
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.
MP
MP Ventilator has detected an internal battery fault.
Consequence: the internal battery is disabled from use.
No internal battery detected.
MP
Yes
Yes
Yes
Yes (except for
CPAP)
Yes
No BATTERY FAULT2
RESTART/SRVC
BUZZER FAULT1
RESTART/SRVC
BUZZER FAULT2
RESTART/SRVC
Defective operation of the buzzers.
MP Yes
Yes
No
Yes
BUZZER FAULT3
RESTART/SRVC
Failure detected in the very high priority buzzer.
Consequence: no audible alarm in case of POWER SUPPLY LOSS alarm.
MP
Battery charge failure due to incorrect voltage. Contact your service representative for assistance.
HP Yes No
User Manual 3-9
Alarms and Troubleshooting
Alarm message
Table 3-1. Overview of Alarms (Continued)
Cause/ventilator response Priority Audio Paused available
Alarm Paused available
Yes Yes BUZZER LOW
BATTERY
CALIBRATE FiO
2
Buzzer battery failure. The battery buzzer voltage is too low.
Internal technical problem that prevents the battery sounding the POWER
SUPPLY LOSS alarm.
MP
An FiO
2
sensor is detected and has not been calibrated.
MP
CALIBRATION FAIL
CHECK BATTERY
CHARGE
IF PERSISTS RESTART/
SRVC
Failure of one calibration point of the internal exhaled flow sensor.
Consequence: failed calibration point is replaced by the default point.
MP
Internal battery charging failure.
Consequence: charging of the internal battery impossible.
MP
CHECK EXH VALVE*
*IF PERSISTS RESTART/
SRVC
Inspired tidal volume during exhalation
<20% of Inspired tidal volume and inspired tidal volume >20mL.
Exhalation valve obstructed.
HP
Yes
Yes
Yes
Yes
CHECK EXH VALVE
PRESSURE
Internal ventilation fault related to exhalation valve detection sensor (pressure sensor).
HP Yes
Yes CHECK FiO
SENSOR
2
CHECK PROXIMAL
LINE1*
*IF PERSISTS RESTART/
SRVC
FiO
2
measurement is less than 18%.
Recalibrate or change FiO
2 sensor.
Loss of signal from the proximal pressure sensor
Consequence: switch to internal pressure sensor for the pressure measurement.
Alarm activation occurs:
In the event of signal loss (1):
After one ventilation cycle or
In the event of signal loss (2) and after the 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
HP
MP Yes
CHECK REMOTE
ALARM
No activation of nurse call or remote alarm system when an alarm is in progress.
MP Yes
Yes
Yes
No
No
Yes
No
No
Yes
3-10 User Manual
User Manual
Overview of Alarms
Alarm message
Table 3-1. Overview of Alarms (Continued)
Cause/ventilator response Priority Audio Paused available
Alarm Paused available
Yes Yes CHECK
SETTINGS
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
MP
CONNECT VALVE
OR CHANGE PRESS
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.
CONTROLLED CYCLES The ventilator is delivering apnea ventilation at set back up rate.
NA
COOLING FAN
RESTART/SRVC
Ventilator cooling fan operating speed not suited to the internal ambient temperature of the device.
HP
MP
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.
MP
HP DEVICE FAULT3
RESTART/SRVC
DEVICE FAULT5
RESTART/SRVC
Detection of a fault in the electrical power supply system.
MP
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.
DEVICE FAULT7
RESTART/SRVC
DEVICE FAULT9
RESTART/SRVC
DEVICE FAULT10
RESTART/SRVC
DEVICE FAULT11
RESTART/SRVC
Consequence: the internal battery capacity is not shown 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.
HP
VHP
VHP
VHP
Yes
NA
Yes
Yes
Yes
Yes
Yes
No
No
No
No
NA
Yes
Yes
No
Yes
No
No
No
No
3-11
Alarms and Troubleshooting
Table 3-1. Overview of Alarms (Continued)
Alarm message Cause/ventilator response Priority Audio Paused available
Alarm Paused available
No No DEVICE FAULT12
RESTART/SRVC
DEVICE FAULT13
RESTART/SRVC
POST reference voltage error. 5 V or 10 V reference voltage error.
Software version error.
VHP
VHP No
E SENS FAULT OR CIRC
LEAK
At least four of the last six breaths within the last minute are terminated by time.
MP
EMPTY BATTERY
Yes
Internal battery capacity <10 minutes or
3%. (battery voltage <22.5V)
Consequence: Ventilation comes to a halt.
HP No
No
No
No
Yes No EXH VALVE
LEAKAGE
Abnormally high expired flow during the inspiratory phase of three consecutive breaths (in double-limb setup).
Alarm activation occurs:
After three consecutive breaths.
FiO
2
SENSOR MISSING No FiO
2
sensor detected and the FiO
2 alarm is active.
MP
HP Yes Yes
HIGH / LOW BATTERY
TEMP*
*IF PERSISTS RESTART/
SRVC
Battery temperature out of tolerance.
Consequence: battery charging stops.
HIGH FiO
2
HIGH INT TEMP COOL
VENT*
*IF PERSISTS RESTART/
SRVC
The level of oxygen delivered by the ventilator exceeds the Max FiO
2
level set.
Device internal ambient temperature out of tolerance range.
HIGH LEAKAGE The leak estimated by the ventilator exceeds the Max leak alarm threshold.
MP
MP
MP
MP
Yes
Yes
Yes
Yes
Yes
No
Yes
No
3-12 User Manual
User Manual
Overview of Alarms
Alarm message
HIGH PRESSURE
HIGH RATE
HIGH VTE
Table 3-1. Overview of Alarms (Continued)
Cause/ventilator response Priority
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 Pi + 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.
Yes
Audio Paused available
Alarm Paused available
No
(The visual portion of the alarm may be paused)
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.
MP
MP
Yes
Yes
No
No
No HIGH VTI 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.
HP Yes
INSP FLOW RESTART/
SRVC
Inspiratory flow is constant
(±1 lpm) with normal turbine temperature and speed conditions. Contact your service representative for assistance.
HP
Ventilation has been stopped voluntarily by the caregiver or patient.
HP
Yes
INTENTIONAL VENT
STOP
Yes
KEYPAD FAULT
RESTART/SRVC*
*IF PERSISTS RESTART/
SRVC
Keyboard key held down for more than
45 seconds.
HP No
No
Yes
No
3-13
Alarms and Troubleshooting
Alarm message
LOW BATTERY
LOW FiO
LOW VTE
LOW VTI
2
Table 3-1. Overview of Alarms (Continued)
Cause/ventilator response Priority Audio Paused available
Alarm Paused available
No Internal battery capacity <30 minutes or
8%.
HP Yes
The level of oxygen delivered by the ventilator is below the Min FiO
2
level set.
MP Yes No
Expired tidal volume less than Min VTE set during three consecutive breaths (in double-limb setup).
Alarm activation occurs:
After three consecutive breaths.
MP Yes No
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.
MP Yes No
NO PROXIMAL LINE2*
*IF PERSISTS RESTART/
SRVC
Proximal pressure < 0.6 mbar for 100 ms during inspiration phase of 3rd breath cycle.
Ventilator response: Switch to internal pressure sensor for pressure measurement.
MP Yes
OCCLUSION
CHECK CIRCUIT*
*IF PERSISTS RESTART/
SRVC
OCCLUSION
CHECK CIRCUIT
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 the tidal volume is less than 20 mL.
HP Yes
Occurs in leak configuration when the leak level is not sufficient to flush the
CO
2
from patient exhalation. The builtin leak in the mask may be obstructed.
The built-in leak for the mask is not sufficient for the settings.
HP Yes
No
No
No
3-14 User Manual
User Manual
Overview of Alarms
Table 3-1. Overview of Alarms (Continued)
Alarm message Cause/ventilator response Priority Audio Paused available
Alarm Paused available
No PATIENT
DISCONNECTION*
*IF PERSISTS RESTART/
SRVC
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.
HP Yes
POWER FAULT
RESTART/SRVC
POWER SUPPLY LOSS
(no message)
PRES SENS FLT1
RESTART/SRVC
PROX SENS FLT2
RESTART/SRVC
REMOVE VALVE
CPAP MODE
REMOVE VALVE OR
CHANGE PRES
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%.
Detection of a fault in the electrical power supply system.
MP Yes
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 or after restoration of the AC or DC supply in case 2.
VHP
Faulty internal pressure sensor signal.
Alarm activation occurs:
After 15 seconds.
No—Alarm cancel only
HP Yes
Yes Faulty proximal pressure sensor signal.
Alarm activation occurs:
After 15 seconds.
MP
The ventilation settings are not compatible with the type of patient circuit used.
Remove exhalation valve to start CPAP ventilation.
HP
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.
HP
Yes
Yes
Yes
No—Alarm cancel only
No
Yes
No
No
3-15
Alarms and Troubleshooting
Table 3-1. Overview of Alarms (Continued)
Alarm message Cause/ventilator response Priority Audio Paused available
Alarm Paused available
N/A N/A SOFTWARE VERSION
ERROR
Detection of a wrong software version.
N/A
TURB OVERHEAT
RESTART/SRVC
Turbine speed too low and temperature too high.
Consequence: ventilation stops immediately and O
2
supply stops.
HP No
UNKNOWN BATTERY The internal battery is not recognized as a Puritan Bennett product battery.
MP Yes
VALVE MISSING
CONNECT VALVE
Connect exhalation valve to start ventilation in V A/C or V SIMV / P SIMV modes.
HP Yes
No
No
No
VTI NOT
REACHED*
*IF PERSISTS RESTART/
SRVC
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.
HP Yes No
3.8
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.
3.8.1
Alarms
offers a guide to the most likely ventilator alarms, possible reasons for the alarms, and corrective actions.
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.
3-16 User Manual
Troubleshooting
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.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance, contact your clinician or equipment representative.
Table 3-2. Alarms and Corrective Actions
Possible reason for the alarm event Alarm message or symptom
AC POWER
DISCONNECTION
Corrective action
APNEA
BATTERY FAULT1
RESTART/SRVC
BATTERY FAULT2
RESTART/SRVC
BUZZER FAULT1
RESTART/SRVC
AC (“mains”) power source cut off.
Cancel the alarm, and then check the supply cable and the effective availability of a voltage on the AC power (“mains”) port.
Cancel the alarm.
Starting with 12–30 VDC external power supply.
Current-limiting fuse of the device blown.
Replace the ventilator and call for the maintenance technician.
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.
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 or components and call your customer service representative.
Battery problem that prevents it from operating.
Internal battery missing or not 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.
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.
User Manual 3-17
Alarms and Troubleshooting
Alarm message or symptom
BUZZER FAULT2
RESTART/SRVC
BUZZER FAULT3
RESTART/SRVC
BUZZER LOWBATTERY
CALIBRATE FiO
2
CALIBRATION FAIL
CHECK BATTERY
CHARGE
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Internal technical problem that prevents the very high priority POWER SUPPLY LOSS alarm from triggering.
Internal technical problem that prevents the battery from correctly charging.
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.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
Internal technical problem that prevents the battery warning buzzer from sounding POWER
SUPPLY LOSS alarm.
Connect the ventilator to an AC power source and power on using the I/O switch located on the rear of the ventilator.
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.
Calibrate FiO
2
sensor.
An FiO
2
sensor is detected and has not been calibrated.
Too large a difference between a calibration point and its tolerance range.
Restart calibration.
There may be a leak in the circuit. Ensure an approved circuit is in use (see circuit documentation).
Incorrect circuit type selected in the Preferences menu.
Verify the circuit selection in the Preferences menu matches the circuit in use.
Exhalation block defective or not properly aligned.
Reset alarm message and ensure all connections are secure, verify circuit integrity, and verify the exhalation block is properly seated.
Defective exhalation flow sensor.
Battery charging impossible.
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
4 , “ Installation and Assembly ,” so that
the power cable cannot be involuntarily disconnected.
In the event the internal battery capacity is low, use an alternate device to ventilate the patient.
Call your customer service representative.
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User Manual
Troubleshooting
Alarm message or symptom
CHECK
EXH VALVE
CHECK EXH VALVE
PRESSURE
CHECK FiO
2
SENSOR
CHECK PROXIMAL LINE1*
*IF PERSISTS
RESTART/SRVC
CHECK REMOTE ALARM
CHECK SETTINGS
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Obstruction or abnormal damage of the exhalation valve.
Excessive moisture in the exhalation block.
Clean or replace the exhalation valve, its control tube, or both.
Remove moisture from exhalation block and valve.
Verify exhalation valve is seated properly.
Reduce temperature of the humidifier.
Defective connection or defective exhalation valve tubing.
Defective inspiratory flow sensor.
Reconnect the valve or replace the exhalation valve, the exhalation valve pilot pressure tube, or both.
Have a qualified technician replace the defective component or components and call your customer service representative.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
The exhalation valve may not be detected by the ventilator when ventilation is started.
The exhalation valve may be falsely detected when ventilation is started.
FiO
2 measured is less than 18%.
Software versions have changed.
Check that FiO
2
sensor is properly connected, or
Recalibrate FiO
2
sensor, or
Replace FiO
2
sensor.
Reconnect the proximal pressure line.
No connection of the proximal pressure tube when ventilation starts.
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.
Nurse call or remote alarm system is disconnected.
Relay control voltage problem.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component or components and call your customer service representative.
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.
Loss of memorized parameters.
Check and adjust the prescribed parameters, if necessary.
Check and adjust the prescribed parameters, if necessary.
3-19
Alarms and Troubleshooting
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action Alarm message or symptom
CONNECT VALVE
OR CHANGE PRESS
CONTROLLED CYCLES
COOLING FAN
RESTART/SRVC
DC POWER
DISCONNECTION
DEVICE FAULT3 IF
PERSISTS RESTART/SRVC
DEVICE FAULT5 IF
PERSISTS RESTART/SRVC
DEVICE FAULT9 IF
PERSISTS RESTART/SRVC
DEVICE FAULT7 IF
PERSISTS RESTART/SRVC
DEVICE FAULT10 IF
PERSISTS RESTART/SRVC
DEVICE FAULT11 IF
PERSISTS RESTART/SRVC
DEVICE FAULT12 IF
PERSISTS RESTART/SRVC
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, and then check the supply wiring and the effective availability of voltage on the external source.
Ventilator’s current-limiting fuse blown.
24 V supply failure.
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.
Internal problem in the electrical power supply.
POST RAM error. RAM read/write does not match memory setting.
Internal technical problem.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
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.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
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.
POST EEPROM error. Startup EEPROM does not match memory setting.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
POST reference voltage error. 5 V or 10 V reference voltage error.
Restart ventilator to see if alarm clears. If not, replace the ventilator and call your customer service representative.
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Troubleshooting
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action Alarm message or symptom
DEVICE FAULT13 IF
PERSISTS RESTART/SRVC
EMPTY BATTERY
E SENS FAULT
OR CIRC LEAK
EXH VALVE LEAKAGE
FiO
2
SENSOR MISSING
Incorrect software version detected.
Internal battery capacity is less than
10 minutes (or 3%) —battery operation overextended.
Leak in the patient circuit, leak in patient artificial airway or vented mask interface.
E sensitivity setting not properly adjusted.
Large leakage detected on the patient circuit return limb during the inspiratory phase.
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, replace the ventilator and call your customer service representative.
Reconnect the device to an AC power outlet, connect it to an external DC power source, or replace the battery.
Reminder: the internal battery can be charged only when the ventilator connected to an AC power supply.
Note:
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 O
2
connector is removed.
Reduce inspiratory time.
Increase E-Sensitivity setting.
Check tracheotomy cuff.
Refit mask.
Use non-vented mask.
Check E Sensitivity setting
Note:
Always consult the clinician before changing PEEP, FiO
2
, pressure, volume or Rate settings.
Replace the exhalation valve and/or its control tube.
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.
3-21
Alarms and Troubleshooting
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action Alarm message or symptom
HIGH FiO
2
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:
Always consult the clinician before changing PEEP, FiO
2
, pressure, volume, or Rate settings.
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User Manual
Troubleshooting
Alarm message or symptom
HIGH INT TEMP
COOL VENT
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Internal ambient temperature of the device out of the tolerance ranges.
Defective internal temperature probe or any other technical anomaly.
Note:
Ensure that you are operating the ventilator within the proper temperature range (see 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.
3-23
Alarms and Troubleshooting
Alarm message or symptom
HIGH/LOW
BATTERY TEMP*
*IF PERSISTS RESTART/
SRVC
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Battery temperature out of the tolerance ranges.
Defective internal temperature probe or any other technical anomaly inside the battery.
Note:
Ensure that ventilator is being used according to the operating
instructions found in Appendix A
,
“
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.
HIGH LEAKAGE
Caution:
The leak estimated by the ventilator exceeds the Max leak alarm threshold.
Do not attempt to charge a defective battery; such a battery cannot be charged.
Readjust mask to reduce leakage or increase the alarm settings.
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User Manual
Troubleshooting
Alarm message or symptom
HIGH PRESSURE
HIGH RATE
HIGH VTE
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Adjustment of Max PIP too low (only for V A/C and V SIMV modes).
Note:
Airway obstruction.
Proximal pressure tube or patient circuit obstructed.
Coughing or other high-flow exhalation efforts.
Patient inspiratory resistance or compliance changes.
Defective internal circuits of the machine or pressure sensor.
Adjustment of the Max Rtot level too low.
Adjustment of the I Sens level too low.
Patient hyperventilating.
Always consult the clinician before changing PEEP, FiO
2
, pressure, volume, or Rate settings.
Increase the Max PIP threshold.
Check patient’s trachea and clear the obstruction. If the filter is obstructed, replace the filter.
Clean the proximal pressure tube or the patient circuit or replace them.
Treat patient’s cough.
Pause the audible alarm, if necessary.
Have physician determine if ventilator settings are appropriate for the patient.
Replace the ventilator and call your customer service representative.
Readjust Max Rtot.
Defective inspiratory flow sensor.
Adjustment of the Max VTE level too low.
Adjust I Sens according to the patient.
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 or components and call your customer service representative.
Note:
Always consult the clinician before changing PEEP, FiO
2
, pressure, volume, or Rate settings.
Modify the Max VTE level.
Inappropriate patient circuit.
Replace the patient circuit.
Ensure there is not excessive airflow near the exhalation block (such as a fan).
Exhalation flow sensor not calibrated properly. Calibrate the exhalation flow sensor.
Defective exhalation flow sensor.
Replace the exhalation block and calibrate the exhalation flow sensor. Call your customer service representative.
3-25
Alarms and Troubleshooting
Alarm message or symptom
HIGH VTI
INSP FLOW
RESTART/SRVC
INTENTIONAL
VENT STOP
KEYPAD FAULT
RESTART/SRVC
LOW BATTERY
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Adjustment of the Max VTI level too low (for
PSV, CPAP, P A/C, P SIMV, and V SIMV modes).
Adjustment of the pressure level too high for the volume required (for PSV, CPAP, P A/C,
P SIMV, and V SIMV modes).
Note:
Always consult the clinician before changing PEEP, FiO
2
, pressure, volume, or Rate settings.
Modify the Max VTI level.
Note:
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.
Defective flow sensor or internal leak in the machine.
Check and properly connect the patient circuit.
Replace the patient circuit.
Have a qualified technician replace the defective component or components 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 standby.
Check that the ventilation was switched off on purpose.
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 or keys, 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 minutes (or 8%)—battery operation overextended.
Immediately connect the ventilator to an AC power outlet or to an external DC power source.
Reminder: The internal battery can be charged only when the ventilator is connected to an AC power supply.
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User Manual
Troubleshooting
Alarm message or symptom
LOW FiO
2
LOW VTE
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
The level of oxygen being delivered to the patient is below the Min FiO
2
limit set.
Patient circuit obstructed.
Leak in the patient circuit.
Note:
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, or properly connect the patient circuit.
Check and properly connect the patient circuit connections.
May be caused by increased resistance across exhalation filter (such as excessive moisture).
Exhalation block missing or disconnected.
Restore or connect the exhalation block (see
, “ Exhalation Block ”). If the exhalation
block has been removed or replaced, calibrate the exhalation flow sensor. 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. Calibrate the exhalation flow sensor.
Defective exhalation flow sensor.
Adjustment of the Min VTE level too high.
Replace the defective component or components and calibrate the exhalation flow sensor.
(Call your customer service representative.
Modify the Min VTE level.
3-27
Alarms and Troubleshooting
Alarm message or symptom
LOW VTI
NO PROXIMAL LINE2
PATIENT
DISCONNECTION
*IF PERSISTS RESTART/
SRVC
OCCLUSION
CHECK CIRCUIT
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
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).
Patient circuit obstructed or disconnected.
Modify the Min VTI level.
Modify the pressure level according to the physician’s prescription.
Clean, unblock, and/or reconnect the patient circuit.
Replace the patient circuit.
Inappropriate patient circuit.
Defective flow sensor or internal leak in the machine.
The proximal pressure line is disconnected.
Adjustment of Min PIP too high.
Check patient, replace the device and call your technician or customer service representative.
Connect proximal pressure line.
Decrease the Min PIP threshold.
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.
Inspiratory flow exceeds 130 LPM.
Check Min PIP alarm setting.
Adjust Apnea alarm setting.
Inappropriate patient circuit.
Defective internal circuits of the machine or pressure sensor.
Patient circuit obstructed.
Replace the patient circuit.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component or components or call your customer service representative.
Clean, unblock, or properly connect the patient circuit.
*IF PERSISTS
RESTART/SRVC
OCCLUSION
CHECK CIRCUIT
POWER FAULT
RESTART/SRVC
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 patient or backup respiratory rate may not sufficiently flush out CO
2
in some vented pediatric masks.
Replace the nonvented 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.
3-28 User Manual
User Manual
Troubleshooting
Alarm message or symptom
POWER SUPPLY LOSS
(without message)
PRES SENS FLT1
RESTART/SRVC
PROX SENS FLT2
RESTART/SRVC
REMOVE VALVE OR
CHANGE PRES
Table 3-2. Alarms and Corrective Actions (Continued)
Possible reason for the alarm event Corrective action
Electrical power supply cut off by the main switch when ventilation is in progress.
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.Press the VENTILA-
TION ON/OFF key again to confirm stop (see
Chapter 5 , “ Operating Procedures ”).
The internal battery that supplies the ventilator is entirely discharged.
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.
Restart ventilator to see if alarm clears. If not, have a qualified technician replace the defective component or components and call your customer service representative.
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 or components and call your customer service representative.
The ventilation settings are not compatible with the type of patient circuit used.
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.
Remove exhalation valve to start CPAP ventilation.
Incorrect software version detected.
Call your customer service representative.
REMOVE VALVE
CPAP MODE
SOFTWARE VERSION
ERROR
TURB OVERHEAT
RESTART/SRVC
Turbine overheated because of blockage during operation.
UNKNOWN BATTERY
VALVE MISSING CONNECT
VALVE
Internal battery not recognized as a
Puritan Bennett product battery.
The ventilation settings are not compatible with the type of patient circuit used.
VTI NOT REACHED
*IF PERSISTS
RESTART/SRVC
Defective inspiratory flow sensor or internal leak of the machine.
I time is not long enough to deliver set VT.
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.
Call your customer service representative.
Connect exhalation valve.
Restart ventilator to see if alarm clears. If not, replace the defective device or devices and have a skilled technician check them.
Call your customer service representative.
3-29
Alarms and Troubleshooting
3.8.2
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.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance, contact your clinician or equipment representative.
Table 3-3. Additional Troubleshooting and Corrective Actions
Conditions
No access to the waveforms
Possible causes
The screen backlight never switches off during ventilation
Backlight set to YES in Preferences menu.
Corrective actions
Display waveform set to OFF in Preferences menu. Set Display waveform to YES in Preferences menu.
Set Backlight to OFF in Preferences menu.
Alarm sound level too low or too high
Poor visibility of the displays
Unusual display on the screen
Adjustment of the alarm sound level is incompatible with the patient’s environment.
Readjust sound level.
Readjust contrast. Contrast adjustment is incompatible with the luminosity of the environment.
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
Light noise
No external power source and the internal battery is completely discharged.
Connect the ventilator to the AC power source.
Turbine noise.
Replace the ventilator and call your customer service representative.
3-30 User Manual
Troubleshooting
Conditions
Whistling noise or vibrations
Excessive heat emitted
Condensation inside the device
Table 3-3. Additional Troubleshooting and Corrective Actions
Possible causes Corrective actions
Filter, turbine silencer, or both have deteriorated.
Replace the ventilator and call your customer service representative.
Valve membranes damaged.
Replace the ventilator and call your customer service representative.
Obstruction of main or secondary air inlets of the casings.
Liquid entered the device.
Remove obstructions from all blocked ventilator air inlets and outlets.
Replace the ventilator and call your customer service representative.
User Manual 3-31
Alarms and Troubleshooting
Page Left Intentionally Blank
3-32 User Manual
4 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 to Chapter
4.1
Installing the Ventilator
To install your Puritan Bennett™ 560 Ventilator:
1.
Choose an area where air can circulate freely. Avoid proximity to loose fabrics, such as curtains, and direct exposure to sunlight.
2.
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, personal injury, or both.
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.
4-1
4-2
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
Appendix A , “ Specifications .” In particular, the use of nearby mobile and portable communications
equipment using radio frequencies, such as mobile telephones or other systems exceeding the levels set in the IEC / EN 60601-1-2 standard, may affect its operation. Refer to section
,
“ Manufacturer’s Declaration .”
User 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.
4.2
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.
User Manual 4-3
Installation and Assembly
To prevent accidental disconnection of the AC power cable, use the power cable holder ( Figure 4-
1. , item 1) that is inserted into the notch ( Figure 4-1. , item 2) of the battery cover.
Figure 4-1. The Power Cable Holder
To secure the AC power cable:
1.
Insert the power cable holder (
Figure 4-2. , item 1) into the notch of the battery cover.
Figure 4-2. 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.
4-4 User Manual
Figure 4-3. 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 indicator on the top left corner of the ventilator illuminates.
• The indicator charged.
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).
User Manual 4-5
Installation and Assembly
Figure 4-4. Power Indicators
4-6
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.
4.3
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.
User 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 (
Figure 4-5. , item 1) that connects to the ventilator’s rear panel
DC power input connector ( Figure 4-5. , item 2). The DC power cable is optional; see Appendix
, “
power source as well.
Figure 4-5. 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 (
User Manual 4-7
Installation and Assembly
Figure 4-6. Connecting the DC Power Cable to the Ventilator
4-8
2.
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
Push the DC power cable onto the ventilator’s DC power connector ( Figure 4-6. , item 2).
•
• You will hear a locking “click”.
The
DC POWER indicator on the top left corner of the ventilator illuminates (see
To disconnect the DC power cable from the ventilator, slide the locking ring (
, 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.
4.4
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.
User Manual
Patient Circuit
WARNING:
For pediatric use, ensure that the patient circuit type fits, and, in all respects, is suitable for use with
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:
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 ventilator) and Chapter 4 , “ Installation and Assembly .”
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 4 , “ Installation and Assembly ” and Appendix
, “
Accessories .” 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.
User Manual 4-9
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.
4.4.1
Choosing the Patient Circuit Type
Single-limb circuits are used with breathing modes where spirometry measurements are not required, and double-limb circuits are used with breathing modes where spirometry is required.
Be sure to choose the appropriate circuit in the menu preferences; in particular, ensure that Pediatric Circuit Yes/No is set to YES when using a pediatric circuit (refer to Appendix
For information regarding validated circuits, visit the SolvIT
SM
Center Knowledge Base by clicking the link at www.medtronic.com/covidien/support/solvit-center-knowledge-base/ or contact your customer representative.
4.4.2
Installing the Patient Circuit
The patient circuit is mounted depending on the setup of the circuit used and the accessories used.
The following procedures describe the installation of the patient circuit with a humidifier. To add other accessories, refer to the installation instructions for the specific accessories used.
To connect a single-limb circuit 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).
4-10 User Manual
Patient Circuit
5.
Place a water trap (item 4) between the outlet port of the humidifier and the inlet of the exhalation valve (item 5).
6.
Ensure the exhalation valve (item 5) is placed as close as possible to the patient.
7.
Connect one end of the proximal pressure tubing (item 7) to the proximal pressure port on the exhalation valve (item 5) and the other end onto the ventilator patient pressure port (item 8).
8.
Connect one end of the exhalation valve tubing (item 6) to the exhalation valve port on the exhalation valve (item 5) and the other end onto the ventilator exhalation valve port (item 9).
9.
To protect the exhalation port (as it will not be used in this configuration), place the cap (if provided with the breathing circuit) over the exhalation port opening (item 10).
Figure 4-7. Single-Limb Patient Circuit With Exhalation Valve
See also Figure 4-9. on page 4-13 .
Note:
, 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.
To connect a double-limb circuit:
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.
3.
Attach one end of the short circuit tubing (item 4) to the filter (item 1).
User Manual 4-11
Installation and Assembly
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 14) 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 4-8. Double-Limb Patient Circuit
4-12 User Manual
Patient Circuit
Note:
, 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 4-9. Closeup of Exhalation Valve Tube and Proximal Pressure Tube
User Manual
1
2
Inhalation port
Exhalation valve tube
3 Proximal pressure tube
Figure 4-9. shows details of the connections of the proximal pressure tube (
, item 6) and the exhalation valve tube (
, item 8).
To connect a single-limb circuit without an exhalation valve (NIV only):
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 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).
4-13
Installation and Assembly
Figure 4-10. Single-Limb Patient Circuit Without Exhalation Valve
4-14
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.
User Manual
Filters
WARNING:
Resistance of the exhalation valve and accessories (water traps, filters, HMEs, etc.) must be as low as possible.
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.
4.5
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 8
,
“ Routine Maintenance ”). This is particularly important when the ventilator is installed on a
wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
•
The ventilator features two filter types:
Air inlet filter
Bacteria filter •
4.5.1
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.
User Manual 4-15
Installation and Assembly
Figure 4-11. Air Inlet Filter
4-16
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.
4.5.2
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
User Manual
Humidifier
Figure 4-12. Bacteria Filter
See the manufacturer’s instructions for more information about the use and maintenance of bacteria filters.
4.6
Humidifier
The 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.
User Manual 4-17
Installation and Assembly
Figure 4-13. Humidifier
4-18
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.
Seethe humidification device’s instructions for information on operating, cleaning, and sterilizing the humidifier.
4.7
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, change it every 4 months.
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.
The exhalation block requires calibration and should only be removed or cleaned by qualified personnel.
User Manual
Oxygen
Figure 4-14. Removing the Exhalation Block
4.8
Oxygen
4.8.1
Administering 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.
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
on page
A-3 for volume and sensitivity tolerances.
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.
Oxygen administered to the patient is introduced from an external source into the machine through the oxygen connector at the rear of the ventilator. It is then integrated into the total volume of delivered gas. Remove the oxygen inlet connector from the back of the ventilator when external oxygen is not in use.
User Manual 4-19
Installation and Assembly
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. As 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.
4.8.2
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.
A connector (
, 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).
Figure 4-15. Rear Panel Oxygen Connector
4-20 User Manual
Oxygen
WARNING:
Before connecting the oxygen supply, ensure that the stud on the oxygen connector ( Figure 4-15. ,
item 3) is protruding outwards.
WARNING:
Inspect the oxygen coupler (
, 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:
See
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.
Figure 4-16. Connecting the Oxygen Supply System
User Manual
To disconnect the oxygen supply system from the ventilator:
Ensure the oxygen source is turned off prior to placing the ventilator in standby or turning off the ventilator.
1.
Stop the oxygen flow from the oxygen supply.
2.
Press the locking tab of the ventilator’s oxygen connector, as shown in
oxygen connection.
4-21
Installation and Assembly
Figure 4-17. Disconnecting the Oxygen Supply System
4-22
3.
Disconnect the oxygen supply’s oxygen connector by pulling it towards you.
The ventilator’s oxygen connector’s locking stud (
Figure 4-16. , 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.
4.8.3
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.
Note:
The FiO
2
sensor requires calibration and should only be removed or cleaned by qualified personnel.
User Manual
Fitting the Ventilator into the Dual Bag
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.
To install the FiO
2
sensor:
Figure 4-18. 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).
4.
Install the adapter on the TO PATIENT
Fit the patient circuit after the adapter.
outlet port, as shown.
4.9
Fitting the Ventilator into the Dual Bag
The dual bag is a carrying bag with a dual function. It allows the Puritan Bennett 560 Ventilator to either be mounted onto a wheelchair or carried as a backpack (see
).
WARNING:
Ensure that the ventilator is switched off and disconnected from all external power supplies before installation.
To fit the ventilator into the dual bag, do the following:
1.
Open the rear panel of the dual bag.
User Manual 4-23
Installation and Assembly
2.
Slip the ventilator into the dual bag, pushing it in completely to ensure a snug fit.
3.
Shut the rear panel of the dual bag ensuring that the hook and loop fastener strips are securely fastened.
4.10
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 disconnection.
WARNING:
To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the ventilator.
Table F-1. , 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.
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.
4-24 User Manual
User Manual
Figure 4-19. Using the Dual Bag Accessory
Mounting the Ventilator on a Wheelchair
To install the dual bag onto a wheelchair, do the following:
1.
Unclip the two backpack straps from the side clips.
2.
Clip the suspension belt onto the central ring.
3.
Secure the dual bag on the wheelchair’s push handle.
4.
Attach the nonadjustable side of the maintaining belt to the side clip of the dual bag.
5.
Pass the maintaining belt around the back of the wheelchair.
6.
Adjust the length of the maintaining belt and attach the adjustable side of the belt to the clip on the other side of the dual bag.
4-25
Installation and Assembly
4.11
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.
4-26 User Manual
Connecting the Nurse Call Cable
4.12
Connecting the Nurse Call Cable
Connect the nurse call cable (
Figure 4-20. , item 1) to the nurse call monitor connector (item 2).
Figure 4-20. 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.
•
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 eight-pin female connector; allowable current is 100 mA at 24 VDC (max).
•
User Manual 4-27
Installation and Assembly
Page Left Intentionally Blank
4-28 User Manual
5 Operating Procedures
5.1
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
(
68°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.
5-1
5-2
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 section
“ Troubleshooting ” 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, as shown in
Figure 5-1. Turning on the Ventilator
User Manual
Turning on the Ventilator
•
•
•
•
•
•
The following events occur:
The ventilator is turned 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 shown 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 shown for about 5 seconds, which includes the machine counter and the patient counter, as shown in
Figure 5-2. 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 nonvolatile 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 screen is then shown.
User Manual 5-3
Operating Procedures
Figure 5-3. Ventilation Menu Parameters
5-4
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.
5.2
USB Menu Parameters
The USB menu is accessible even if the Locking key has been enabled. The USB menu is automatically shown 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 shown. The USB menu is not accessible from the Setup menu or Maintenance menu.
To access patient 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.
5.2.1
USB Memory Device Specifications
Characteristics
USB compatibility
Number of files
USB size
Table 5-1. USB Memory Device Specifications
Supported formats
USB flash memory USB 2.0 or USB 1.1, 32 bit format
Maximum 999 (sector size: 512-2048 bytes)
128 MB to 4Gb (To guarantee accuracy of transfer time, at least 10% of the
USB memory device capacity must be free).
User Manual
5.2.2
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 5-4. Selecting the USB Menu
USB Menu Parameters
•
•
In case of high priority alarm activation the ventilator will automatically show the alarm page. To return to the USB menu, press the MENU key.
•
The adjustable parameters in this menu include the following:
Transfer Continuously
Transfer Trends
Erase Key
5.2.3
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.
User Manual 5-5
Operating Procedures
Figure 5-5. Selecting Transfer Continuously
5-6
To transfer continuous data from a ventilator to a USB memory device:
1.
Use the UP DOWN 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.
Press UP DOWN to change the selected parameter’s value.
4.
Press ENTER to confirm the new parameter setting.
•
The new parameter setting is shown continuously.
The cursor is placed at the STOP position.
•
5.
To manually stop continuous transfer, press the ENTER key.
If a parameter change is not confirmed by pressing ENTER before 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 shown during the transfer time.
Note:
Other functions of the USB memory device are not available during continuous recording,
User Manual
USB Menu Parameters
Note:
If the memory capacity on the USB memory device is insufficient the message “TRANSFER NOT ALLOWED
- USB CAPACITY INSUFFICIENT” is shown and data transfer is not allowed. Delete the data on the USB memory device before restarting data transfer.
Note:
In case of USB memory device disconnection or transfer error, the message “TRANSFER ERROR - USB
DISCONNECTION” or “TRANSFER ERROR - TECHNICAL PROBLEM” is shown. In this case, restart the transfer process. If the problem persists, contact your technical service representative.
5.2.4
Transfer Trends
Up to 1 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 5-6. Selecting Transfer Trends
User Manual
To transfer trend data from a ventilator to a USB memory device:
1.
Use the UP DOWN 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.
Press UP DOWN to change the selected parameter’s value.
4.
Press ENTER to confirm the new parameter setting.
5-7
5-8
Operating Procedures
•
•
The new parameter setting is shown 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 before 7 seconds elapse, the ventilator resets the parameter to its previous value.
Table 5-2. Time taken to transfer trends data from the ventilator to a USB memory device
Amount of trends data
(in months)
Transfer time from ventilator to
USB memory device
3 months
6 months
Approximately 2 minutes
Approximately 4 minutes
9 months
12 months
Approximately 6 minutes
Approximately 8 minutes
Note:
The message “TRANSFER IN PROGRESS... REMAINING TIME” is shown 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 shown and data transfer is not allowed. Delete the data on the USB memory device before restarting data transfer.
Note:
In case of USB memory device disconnection or transfer error, the message “TRANSFER ERROR - USB
DISCONNECTION” or “TRANSFER ERROR - TECHNICAL PROBLEM” is shown. In this case, restart the transfer process. If the problem persists, contact your technical service representative.
5.3
Starting Ventilation
Before starting ventilation, see Appendix
C , “ Operational Verification Checklist ,” and set the param-
eter values in the Preferences menu.
WARNING:
Verify the functionality of the alarm conditions before connecting the patient to the ventilator.
User Manual
Starting Ventilation
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.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance, contact your clinician or equipment representative.
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
shown in the right-hand window of the Ventilation and Alarm menus ( Figure 5-7. ).
Figure 5-7. Prompt to Start Ventilation
User Manual
•
•
•
To start ventilation:
•
Press and release VENTILATION ON/OFF (
The blue light indicator, at the upper right of the VENTILATION ON/OFF key
(see
, item 2), turns off.
A “beep“ sounds.
The ventilation starts.
The values of the monitored parameters are shown in the right-hand window.
5-9
Operating Procedures
Figure 5-8. Starting Ventilation
5.4
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:
1.
Press and hold the VENTILATION ON/OFF key (
Figure 5-8. , item 1) for 3 seconds.
A message prompting the user to keep the button pressed appears on the monitoring window, as shown in
:
Figure 5-9. Stopping Ventilation (1)
5-10 User Manual
Turning Off the Ventilator
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
Figure 5-10. Stopping Ventilation (2)
•
A double “beep“ sounds.
3.
Release the VENTILATION ON/OFF key.
4.
Press the VENTILATION ON/OFF key within 5 seconds to confirm stop, otherwise ventilation will continue.
• Ventilation stops.
•
•
The blue LED located to the upper-right of the VENTILATION ON/OFF (
2) illuminates to indicate ventilation is on standby.
A prompt for a new start of ventilation is shown (see Figure 5-7. on page 5-9 ).
5.5
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 turn off the ventilator.
The blue LED to the right of the VENTILATION ON/OFF key turns off.
User Manual 5-11
Operating Procedures
• 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.
5-12 User Manual
6 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.
6.1
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.
6-1
6-2
Internal Battery
With a fully charged battery at a normal room temperature of 25ºC (± 5ºC), 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 standby mode or while providing ventilation) and read the percent charge level shown adjacent to the battery icon at the top of the ventilator's display screen.
Table 6-1. Internal Battery Reserve Capacity
Displayed values
Average operating time on internal battery power
1
Vt = 200 ml (±5 ml)
PIP = 10 mbar (±2 mbar)
Rate = 20 bpm
11 hours (–10%)
Vt = 300ml (±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 ventilation parameters)
9 hours (–10%)
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.
6.2
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.
Note:
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 shown at the top on the general information line.
•
User Manual
Battery Operation
•
•
Battery reserve capacity is shown on the right of the symbol.
Figure 6-1. Internal Battery Indicator
• A loss of external supply alarm is activated.
If ventilation is stopped, the internal battery reserve capacity is shown as a percentage of battery charge. See
Figure 6-2. Battery Reserve Capacity as a Percentage
User Manual
If the ventilator is running, the internal battery reserve is momentarily shown as a percentage.
Then, after the ventilator calculates the battery time remaining (which takes about 2 minutes,
6-3
Internal Battery depending on the power consumption of the ventilator), the internal battery reserve is then shown in hours and minutes (rounded to the nearest 10 minutes). See
Figure 6-3. Battery Reserve Capacity in Hours and Minutes
6-4
The LOW BATTERY and EMPTY BATTERY alarms (see Chapter
3 , “ Alarms and Troubleshooting ”) are
triggered when the internal battery reserve is reduced.
WARNING:
Due to its limited internal battery’s reserve capacity, the ventilator should only be operated on the internal battery when no other power source is available. Ensure that the internal battery never becomes fully discharged.
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.
6.3
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.
User Manual
Recharging the Battery
6.4
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 (
•
Figure 6-4. 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.
User Manual 6-5
6-6
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 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.
6.5
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.
Note:
If the battery is stored for more than 1 month at a temperature greater than 21°C (70°F), or for more than
1 or 2 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.
Note:
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”).
Note:
The battery should not be stored for more than 2 years, whatever the conditions.
User Manual
7 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.
WARNING:
To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
7.1
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.
7-1
7-2
Cleaning
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.
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 7-1. 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 warnings in this section.
4.
Dry the ventilator surface with a clean, soft, lint-free cloth.
7.2
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.
User Manual
Cleaning the Exhalation Block
7.3
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.
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.
Note:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance, contact your clinician or equipment representative.
User Manual 7-3
Cleaning
Page Left Intentionally Blank
7-4 User Manual
8 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.
8.1
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 ( Figure 8-1. , item 2) and discard it.
3.
Place the new filter in the device, while ensuring that:
8-1
Routine Maintenance a.
b.
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.
Figure 8-1. Replacing the Air Inlet filter
8.2
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:
Elements
Air inlet filter
(foam + fine particle)
Inspirited bacteria filter
Patient circuit
FiO
2
sensor
Table 8-1. Consumables and Replacement Intervals
Recommended replacement intervals
Once a month or more often, depending on the extent of soiling
See manufacturer’s recommendation
See manufacturer’s recommendation
Single use single patient
14 to 18 months or more often in case of persistent calibration failure
8-2 User Manual
Recommended Schedule of Maintenance
Elements
Exhalation block
Note:
Table 8-1. Consumables and Replacement Intervals (Continued)
Recommended replacement intervals
4 months(*) (and for each new patient)
For a list of parts and accessories, see Appendix
F , “ Parts and Accessories ” or contact your service
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 .
Note:
** This minimum replacement period is based on bench test validation performed under 24/24 continuous ventilation and active humidification conditions over a period of 3 months. (Test report
N°08DE265). Test report results show that no condensation or drops of water that would affect flow measurement were found in the exhalation block or the Piezzo valve.
Note:
For all additional accessories not necessarily considered as consumables consult the manufacturer’s recommendations.
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 7.3
, “
”). The exhalation block should be changed every 4 months and cannot be reused with any other patient.
User Manual 8-3
8-4
Routine Maintenance
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
, “ Battery Operation ”). Such a test is imperative after
opening the ventilator or after a prolonged period of non-use (1 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.
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.
8.3
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.
User Manual
Service Assistance
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
3 , “ Alarms and Troubleshooting .” If you
cannot determine the cause of the problem, contact your equipment supplier or Covidien.
For more information and local Covidien Technical Service contact details, see
in the Preface.
User Manual 8-5
Routine Maintenance
Page Left Intentionally Blank
8-6 User Manual
A Specifications
A.1
Physical
Ventilator weight
Ventilator dimensions
Connectors
Device airway volume
Breathing circuit volume
• Adult, dual limb
• Pediatric, dual limb
• Adult, single limb
• Pediatric, single limb
Air inlet filter
Table A-1. Physical Description (Excluding Accessories)
9.9 lb. (4.5 kg)
9.25 in wide x 12.40 in deep x 6.0 in high
(235 mm wide x 315 mm deep x 154 mm high)
Inspiratory limb connector: ISO 22 mm (OD) conical
Exhalation limb connector (on exhalation block): ISO 22 mm (ID) conical
Oxygen inlet: female connector with valve
2000 ml
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: 4mbar at 60 lpm
A.2
Electrical
Voltage
100 VAC to 240 VAC
12 VDC
30 VDC
Table A-2. AC Electrical Supply
Frequency Consumption
50 Hz / 60 Hz
N/A
N/A
180 VA max
8.3 A
3.3 A
A-1
Specifications
Voltage
Full-load capacity
Ampere-hour rating
Table A-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
124 Wh to 126 Wh
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 A-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 at 24 VDC
(maximum).
Nurse call pin-out (view from back of ventilator)
7
8
5
6
3
4
1
2
Pin Signal relay common normally open (NO) normally closed (NC) remote supply—(not used)
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
A-2 User Manual
Indicators and Alarms
A.3
Indicators and Alarms
Ventilation ON/OFF
• Blue in standby mode
• Not lit if ventilation is in progress.
Table A-5. Power Indicators
AC power
Green
DC power
Green
Internal battery
• Flashing if the battery charge is in progress.
• Continuously lit if the ventilator is powered by the internal battery.
Table A-6. Alarm Indicators
High priority
Red flashing LED
Medium priority
Yellow flashing LED
Audio paused
Table A-7. Audio Alarms
Alarm volume
60 s ±1 s 65 to 80 dBA ±10% at 1 meter
A.4
Performance
A.4.1
Specifications
Table A-8. Performance Parameter Specifications and Tolerances
1
Settings
Volume
Pressure
Time
Rate
Inspiratory Sensitivity
Exhalation Sensitivity
Range
50 to 2000 ml
5 to 55 mbar
0.3 to 6.0 s
1 to 60 bpm
0P to 5
5 to 95%
Tolerances
±(10 ml + 10%)
±(1 mbar +10%)
±10%
±1 bpm
N/A
±(4 lpm + 10% of target exhalation flow) based on E Sens within 50ms
Vt Sigh
I:E Ratio
I/T Ratio
Vt x1 to Vt x 2
1:4 to 1:1
20% to 50%
±(20ml + 20%)
Insp. time ±50 ms and Exh. time ±50 ms or I:E ratio ±10%, whichever is greater
Insp. time ±50 ms and Exh. time ±50 ms or I/T ratio ±10%, whichever is greater
1.
The ventilator parameters’ displayed values could vary based on patient settings.
User Manual A-3
Specifications
A.5
Monitored Parameters
Table A-9. Monitored Parameter Tolerance
Ventilator parameters
Peak Inspiratory Pressure (PIP)
Tolerances
±(2 mbar + 8%)
Positive End Expiratory Pressure (PEEP)
1
Inspiratory Tidal Volume (VTI)
±(2 mbar + 8%)
Exhalation Tidal Volume (VTE)
Total Breath Rate (Rtot)
I:E Ratio (I:E)
I/T Ratio (I/T)
±(10 ml + 10%) and ±(20 mL + 20%) in CPAP mode above 200 mL or in NIV configuration
±(10 ml + 10%)
±1 bpm
Inspiratory Time (I Time)
Exhalation Time (E Time)
Inspiratory Minute Volume (M VoI)
Insp. time ±50 ms and Exh. time ±50 ms or I:E ratio
±10%, whichever is greater
Insp. time ±50 ms and Exh. time ±50 ms or I/T ratio
±10%, whichever is greater
±100 ms
±100 ms
±(10 mL + 10% VTI) x Rate (with exhalation valve) and ±(20 mL + 20% VTI) x Rate in NIV configuration (without exhalation valve)
Vt Sigh
FiO
2
Leak
Apnea Index (AI)
Apnea Time
% Spontaneous (Spont)
Peak Airway Pressure (Paw)
±(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.
A.6
Range, Resolution, and Accuracy
patient data.
A-4 User Manual
Ventilator settings
Mode
Tidal volume (Vt)
Vt Target
Inspiratory Pressure (Pi)
Pressure support
(P Support)
I:E Ratio (I:E)
I/T Ratio (I/T)
Inspiratory time (Insp Time)
User Manual
Range, Resolution, and Accuracy
Table A-10. Ventilator Range, Resolution, and Accuracy
Range, resolution, and accuracy
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
Range: 50 mL to 2000 mL
Resolution: 10 mL
Accuracy: Vt target < VTI < Vt target + 20% if Max P is high enough to reach Vt target
Default value: OFF (100 mL)
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 in valve 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
Accuracy: Insp. time ±50 ms and Exh. time ±50 ms or I:E ratio ±10%, whichever is greater
Default value: 1/2
Range: 20% to 50%
Resolution: 1%
Accuracy: Insp. time ±50 ms and Exh. time ±50 ms or I/T ratio ±10%, whichever is greater
Default value: 33%
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: ±10%
Default value: 1.5 s
Depends on: R-Rate, Vt in V SIMV mode
Depends on: R-Rate in P SIMV mode
A-5
Specifications
Ventilator settings
Respiratory rate (R-Rate)
Inspiratory sensitivity (I Sens)
Exhalation sensitivity (E Sens)
Ramp (Flow Pattern)
PEEP
Rise time
Backup rate
Table A-10. Ventilator Range, Resolution, and Accuracy (Continued)
Range, resolution, and accuracy
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
Range: 0P-5
Resolution: 1
Accuracy: N/A
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 Pi 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
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)
A-6 User Manual
Range, Resolution, and Accuracy
Ventilator settings
Apnea time
Minimum Inspired Tidal Volume
(Min 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)
Minimum inspiratory time
(Min I time)
Table A-10. Ventilator Range, Resolution, and Accuracy (Continued)
Range, resolution, and accuracy
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 2000 mL
Resolution: 10 mL
Default value: 300
Depends on: Max VTI
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 in CPAP, P A/C, and V A/C modes and 17 bpm to 70 bpm in
PSIMV and VSIMV modes
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
Range: 0.1 to 2.8 s
Resolution: 0.1 s
Default value: AUTO (Rise time + 300 ms)
Depends on: Max I Time, Backup R, Rise time
User Manual A-7
Specifications
Ventilator settings
Maximum inspiratory time
(Max I time)
Maximum Fraction of Inspired Oxygen
(Max FiO
2
)
Table A-10. Ventilator Range, Resolution, and Accuracy (Continued)
Range, resolution, and accuracy
Range: 0.8 to 3 s
Resolution: 0.1 s
Default value: AUTO (minimum of 3 s or 30/monitored rate)
Depends on: Min I Time, R-Rate
Minimum Fraction of Inspired Oxygen
(Min FiO
2
)
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
A.7
Environmental
The following environmental conditions shall be observed:
Temperature
-40°C to +70°C (-40°F to
+158°F)
Table A-11. Environmental Conditions for Storage or Transport
Humidity
10% to 95% RH
Atmospheric pressure
500 hPa to 1060 hPa (7 psi to 15.4 psi)
Altitude
-152 m to 3964 m
(500 ft to 13 000 ft)
Temperature
+5°C to 40°C (+41°F to
104°F)
Table A-12. Environmental Conditions for Operation
Humidity
10% to 95% RH
Atmospheric pressure Altitude
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 nor endanger the user. However, operating the device for prolonged periods or repeatedly under such extreme conditions could result in premature aging of components and more frequent maintenance.
A.8
USB
Characteristics
USB compatibility
Memory file format
Table A-13. USB Memory Device Specifications
Supported formats
USB flash memory USB 2.0 or USB 1.1
USB 32 bit format (sector size: 512 - 2048 bytes)
A-8 User Manual
Characteristics
Number of files
USB size
Table A-13. USB Memory Device Specifications
Supported formats
Maximum 999
128 MB to 4 GB
Ventilator data description
Trends capacity
Table A-14. Data Transfer Characteristics
Capacity
86 MB
Events capacity
Monitoring capacity
512 KB or 5500 events
42 MB /48 hours
A.9
Pneumatic
Working pressure
5 mbar–
55 mbar
Inspiratory
Table A-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 A-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 A-17. Air Inlet Resistance (Filter)
1.1 cmH2O (1.079 mbar) at 30 lpm flow
Table A-18. Oxygen Inlet Specifications
Maximum pressure Maximum flow
50 kPa (7 psi) 15 lpm
Sound pressure level
Table A-19. Performance Specifications
Maximum pressure limit
Internal compliance
(ventilator)
30 dBA (per NF EN
ISO 17510-1 test conditions)
60 mbar 0.0001 l/mbar
Inspiratory triggering response time (Ttr)
100 ms
Pneumatic
User Manual A-9
Specifications
A.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
Table A-20. Electromagnetic Emissions
Group 1 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.
RF emissions
CISPR 11/EN 55011
Harmonic emissions
IEC/EN 61000-3-2
Voltage fluctuations/ flicker emissions
IEC/EN 61000-3-3
Class B
Class A
Complies
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.
Immunity test
Table A-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.
IEC/EN 60601 test level Compliance level Electromagnetic environment–guidance
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
Electrical fast transient/burst
IEC/EN 61000-4-4
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
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.
A-10 User Manual
Manufacturer’s Declaration
Immunity test
Table A-21. Electromagnetic Immunity (Continued)
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.
IEC/EN 60601 test level Compliance level Electromagnetic environment–guidance
Surge
IEC/EN 61000-4-5
±1 kV lines/lines ±1 kV lines/lines
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC/EN 61000-4-11
±2 kV lines/earth
<5% UT
(>95% dip in UT for 0.5 cycle)
40% UT
(60% dip in UT for 5 cycles)
70% UT
(30% dip in UT for 25 cycles)
±2 kV lines/earth
<5% UT
(>95% dip in UT for 0.5 cycle)
40% UT
(60% dip in UT for 5 cycles)
70% UT
(30% dip in UT for 25 cycles)
AC power (“mains”) power quality should be that of a typical commercial or hospital environment.
AC power (“mains”) power quality should be that of a typical commercial or hospital environment. If the user of the ventilator requires continued operation during power mains interruptions, it is recommended that the ventilator be powered from an uninterruptible power supply or a battery.
<5% UT
(>95% dip in UT for 5 s)
3 A/m
<5% UT
(>95% dip in UT for 5 s)
3 A/m Power frequency
(50/60 Hz) magnetic field
IEC/EN 61000-4-8
Note:
UT is the AC mains voltage prior to application of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
User Manual A-11
Specifications
Table A-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
Conducted RF
IEC/EN 61000-4-6
3 Vrms
150 kHz to 80 MHz outside
ISM bands
1
10 Vrms inside ISM bands
1
3 Vrms
150 kHz to 80 MHz outside ISM bands
10 Vrms inside ISM bands d = 0.35√P 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:
A-12 User Manual
User Manual
Manufacturer’s Declaration
Table A-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.
Table A-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 d = 0.35
P d = 1.2
P d = 1.2
P d = 2.3
P
0.01
0.1
1
10
100
0.035 m
0.11 m
.35 m
1.1 m
3.5 m
0.12 m
0.38 m
1.2 m
3.8 m
12 m
0.12 m
0.38 m
1.2 m
3.8 m
12 m
0.23 m
0.73 m
2.3 m
7.3 m
23 m
A-13
Specifications
Table A-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
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.
Table A-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
Australia 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)
1.8 m (5.9 ft)
A-14 User Manual
Standards Compliance and IEC Classification
Table A-24. Compliant Cables and Accessories (Continued)
Cable or accessory
Europe AC power cable assembly
Maximum length
1.8 m (5.9 ft)
Canada AC power cable assembly
Nurse call cable
12V DC car adapter cable
Oxygen inlet connector
1.8 m (5.9 ft)
5 m (16.4 ft)
-
5 m (16.4 ft)
A.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 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.
•
•
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.
User Manual A-15
Specifications
•
•
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 5356-
1:2004.
•
Air Transportation Standards
Environmental Conditions and Test Procedures for Airborne Equipment - RTCA/DO-160:2007.
A-16 User Manual
B Modes of Ventilation
B.1
Modes of Ventilation
This chapter is a general description of the various modes of ventilation and breath types available with the Device name.
Note:
The default ventilation mode setting is P A/C; for more information, see below.
B.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
B.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.
B-1
Modes of Ventilation
•
•
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
B.1.3
CPAP Mode
In CPAP, the ventilator maintains a constant level of pressure in the patient’s airway.
B.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.
B-2 User Manual
C Operational Verification Checklist
•
•
•
The operational verification and safety checks listed in
Table C-1. below should be performed
to ensure the ventilator is operating properly in the following circumstances:
Prior to using the ventilator with a patient
Monthly while the ventilator is in use
Following maintenance or changes in ventilator settings
If the ventilator fails any of the safety checks below, or if you cannot complete these checks, see section
” or call the equipment supplier or Covidien (see section 8.3
, “
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.
7
8
1
2
3
4
5
6
Table C-1. Operational Verification Checklist
Verify the proper appearance and cleanliness of the ventilator.
Verify all of the labels and markings on the ventilator are clear and legible.
Confirm the air inlet filter is clean and correctly installed.
Ensure the AC power cable does not exhibit any signs of damage, such as kinks, breaks, or damaged insulation.
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.
Perform the Functioning Alarms Test. See Appendix E , “ Alarms Tests
.”
Verify the alarm volume is adapted to the patient environment.
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
C-1
Operational Verification Checklist
9
10
Table C-1. Operational Verification Checklist (Continued)
Verify that the preventive maintenance schedule for the ventilator is followed. See
, “
.”
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
C-2 User Manual
D 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 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 Ventilator. See
.
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 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.
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.
D-1
Unpacking and Preparation
4.
Clean the ventilator with a mild soap solution, if necessary (see Chapter
5.
Ensure that the air inlet filter is installed.
Figure D-1. Puritan Bennett 560 Ventilator
D-2 User Manual
Figure D-2. Dual Bag
User Manual D-3
Unpacking and Preparation
Page Left Intentionally Blank
D-4 User Manual
E 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 3 , “ Alarms and Troubleshooting ”) of this manual or call
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:
Many of the functions of the ventilator are not accessible when the Locking key is enabled. For additional assistance contact your clinician or equipment representative.
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.
E.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.
E-1
Alarms Tests
2.
Press the VENTILATION ON/OFF key to start ventilation.
3.
Keep the patient‘s end of the breathing circuit open and allow ventilation to continue.
4.
Wait for (Apnea time + 2 seconds; Apnea time is not always 5 seconds), then ensure that:
•
•
• The High priority indicator (red color) lights up
The “PATIENT DISCONNECTION” alarm is shown
The audible alarm sounds
5.
Press the ALARM CONTROL key once to pause the alarm.
6.
Press and hold the VENTILATION ON/OFF key for 3 seconds, then release it. Press the VENTILA-
TION ON/OFF key again to confirm stop.The ventilator will switch to standby mode and cancel the alarms.
E.2
Circuit Check Test
E.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.
1.
Press and hold the MENU key during power up to access the circuit check test screen.
Figure E-1. Circuit Check Screen (Before Starting)
E-2
Note:
Before performing a circuit check, stop ventilation using the VENTILATION ON/OFF not
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.
User Manual
Circuit Check Test
2.
Verify that the proximal pressure tube of the patient circuit is properly connected to the proximal pressure port (see section
, “
Patient Circuit ,” on page 4-8 .)
3.
Verify that the exhalation valve tube is connected to the exhalation valve port.
4.
Block the patient connection port of the patient circuit (see
Figure E-2. Blocking the Patient End of a Single Limb Circuit
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
Show Test Status as RUNNING (see
Figure E-3. Circuit Check (Running)
User Manual d.
Increase pressure to 30 mbar (±10% with no leak)
E-3
Alarms Tests g.
h.
e.
f.
Display flow sensor measurement as Leak in Lpm (updated every 2 seconds)
Sound a short beep every time the flow measurement is updated
Sound a long audible beep once the check is complete
Show PASS or FAIL in the Test Status field
Figure E-4. Circuit Check (Complete, Passed)
Figure E-5. Circuit Check (Complete, Failed)
E-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.
E.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.
User Manual
Power Failure Test
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.
E.3
Power Failure Test
Note:
If the ventilator is operating on either the external power supply or the internal battery, you must plug it in to an AC power source before beginning this test.
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 INTER-
NAL BATTERY indicator illuminates
2.
Press the ALARM CONTROL key twice to reset the alarm.
3.
Reconnect the ventilator to its AC power supply.
E.4
Occlusion Test
Note:
Occlusion testing can only be done in Pressure modes.
1.
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 4.4
, “
”).
2.
Block the patient wye at the end of the patient circuit. See
User Manual E-5
Alarms Tests
Figure E-6. Blocking the Patient End of a Patient Circuit
E-6
3.
Press the VENTILATION ON/OFF key to start ventilation.
4.
Allow the ventilator to deliver three 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
key to pause the alarm.
5.
Press the ALARM CONTROL
6.
Unblock the patient wye.
•
The alarm is canceled.
7.
Press and hold the VENTILATION ON/OFF key for 3 seconds, then release it. Press the VENTILA-
TION ON/OFF key again to confirm stop.
• Ventilation stops.
E.5
Battery Test
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
User Manual
Involuntary Stop Test
• The BATTERY symbol is shown 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 symbol is no longer shown at the top of the screen
E.6
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 turn off 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 shown.
3.
Press the ALARM CONTROL key once to pause the audible alarm.
User Manual E-7
Alarms Tests
Page Left Intentionally Blank
E-8 User Manual
F Parts and Accessories
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 combination foam/ fine particle air inlet filters, one carrying bag, one O
2
connector, and one AC power cable.
Table F-1. List of Consumables and Accessories
Description
Carrying bag (grey)
Oxygen inlet connector
Ventilator cart
Dual bag (blue or pink)
delivered with:
Backpack padded straps, 2 each
Suspension belt
Carrying belt
WARNING:
To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the ventilator.
AC (mains) power cable
DC power cable (for connection to an external DC power source, such as a car 12 volt DC outlet)
Remote Alarm cable (5 meters)
Exhalation block, single-patient use (blue)
Inlet air combi-filter, fine (pack of 6)
Note:
This is the “foam plus fine particle” filter listed in
Replacement Intervals on page 8-2 ).
F-1
F-2
Parts and Accessories
Table F-1. List of Consumables and Accessories (Continued)
Description
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)
Table F-2. provides a list of consumable parts available for the ventilator.
Note:
To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this
manual; see Chapter 4 , “ Installation and Assembly
” and Appendix F , “ Parts and Accessories .” The total
specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 1.1 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.
Table F-2. List of Circuits
Description
DAR™ Double-limb patient circuit with exhalation valve, 180 cm, PVC, ADULT
DAR™ Double-limb patient circuit with exhalation valve, 180 cm, PVC, PEDIATRIC
5094000
5093900
Part number
User Manual
Table F-2. List of Circuits (Continued)
Description
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
Part number
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 www.covidien.com/rms/products.
User Manual F-3
Parts and Accessories
Page Left Intentionally Blank
F-4 User Manual
G Glossary
AC Power
Alternating current.
Alarm Pause
The audible and visual alarms cease and the symbol appears. The symbol will remain until the cause of the alarm is addressed. For example, when the ventilator is running on internal battery, the AC Disconnection alarm may be paused, and the alarm paused symbol will appear until the device is plugged into AC. The paused alarm will be captured in the alarm log screen and can be reactivated.
Alarm Reset
Used only for the High Pressure alarm, this function resets the visual alarm message.
Apnea
The absence of breathing or a breathing pattern capable of supporting an individual's respiratory needs.
Apnea Index (AI)
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.
G-1
Glossary
Audio Pause
Pauses the audible alarm for 60 seconds at a time and shows the symbol.
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.
G-2 User Manual
User Manual
Exhaled Tidal Volume (VTE)
Exhaled volume measured for all breath types through the exhalation block. Monitored value available only with double-limb patient circuit.
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 that 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.
G-3
Glossary
Inspiratory Tidal Volume (VTI)
Volume delivered to the patient at each inspiratory phase.
I Time (Inspiratory Time)
Inspiratory time measure.
Intentional Vent Stop Alarm
Ventilation has been switched off by the user/caregiver and the ventilator is in standby.
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 unexpected 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.
G-4 User Manual
User Manual
Mean Airway Pressure
Average patient pressure during each breath.
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).
Nurse Call
This function allows for remote alerts of ventilator alarm conditions (for example, when the ventilator is in an isolation room).
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.
G-5
Glossary
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 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 Puritan Bennett™560 Ventilator is flow-triggered, with sensitivity levels in the range from
0P 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 (for example, every 50 breaths).
Spont Cyc (Spontaneous Cycling)
This is the percentage of ventilation cycles initiated by the patient over the previous 24-hour period.
G-6 User Manual
User Manual
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.
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.
G-7
Glossary
Page Left Intentionally Blank
G-8 User Manual
Index
A
AC power
AC power cable
AC POWER DISCONNECTION alarm message . . . . . . . . . . . . . . 3-9, 3-17
Air Inlet filter
Air outlet (antibacterial) filter, replacement interval . . . . . . . . . . . . . 8-2
Air transport
Air transportation standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-16
rules for carry on baggage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
use on commercial aircraft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Alarm Logs menu
Alarm messages
AC POWER DISCONNECTION . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-17
BATTERY FAULT1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9, 3-17, 6-4
BATTERY FAULT2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-17
BUZZER LOW BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-18
CALIBRATE FIO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-18
CALIBRATION FAIL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-18
CHECK BATTERY CHARGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-18
CHECK EXH VALVE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-19
CHECK EXH VALVE PRESSURE . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-19
CHECK FIO2 SENSOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-19
CHECK PROXIMAL LINE1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-19
CHECK REMOTE ALARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10, 3-19
CHECK SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-19
CONNECT VALVE OR CHANGE PRESS . . . . . . . . . . . . . . . . . .3-11, 3-20
CONTROLLED CYCLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
COOLING FAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
DC POWER DISCONNECTION . . . . . . . . . . . . . . . . . . . . 3-11, 3-20, 4-8
DEVICE FAULT10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
DEVICE FAULT11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
DEVICE FAULT12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-20
DEVICE FAULT13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-21
DEVICE FAULT3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
DEVICE FAULT5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
DEVICE FAULT7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
DEVICE FAULT9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11, 3-20
E SENS FAULT OR CIRC LEAK . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-21
EMPTY BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 3-21, 6-4
EXH VALVE LEAKAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-21
FIO2 SENSOR MISSING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-21
HIGH INT TEMP COOL VENT . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-23
HIGH LEAKAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-24
HIGH PRESSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13, 3-25
HIGH/LOW BATTERY TEMP . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 3-24
INTENTIONAL VENT STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13, 3-26
LOW BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7, 3-14, 3-26, 6-4
NO PROXIMAL LINE2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14, 3-28
OCCLUSION CHECK CIRCUIT . . . . . . . . . . . . . . . . . . . . . . . . . 3-14, 3-28
PATIENT DISCONNECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-28
POWER FAULT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-28
POWER SUPPLY LOSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
PRES SENS FLT1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
PROX SENS FLT2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
REMOVE VALVE CPAP MODE . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
REMOVE VALVE OR CHANGE PRES . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
SOFTWARE VERSION ERROR . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
TURB OVERHEAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
UNKNOWN BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
VALVE MISSING CONNECT VALVE . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
VTI NOT REACHED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
Alarms
Alarms tests
APNEA alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-17
B
BATTERY FAULT1 alarm message . . . . . . . . . . . . . . . . . . . . . 3-9, 3-17, 6-4
BATTERY FAULT2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-17
Battery, internal
indicator, front panel (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
IN-1
BUZZER FAULT1 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-17
BUZZER FAULT2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-18
BUZZER FAULT3 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9, 3-18
BUZZER LOW BATTERY alarm message . . . . . . . . . . . . . . . . . . 3-10, 3-18
C
CALIBRATE FIO2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-10, 3-18
CALIBRATION FAIL alarm message . . . . . . . . . . . . . . . . . . . . . . . 3-10, 3-18
Carbon dioxide, risk of inhalation and suffocation . . . . . . . . . . . . . .5-10
CHECK BATTERY CHARGE alarm message . . . . . . . . . . . . . . . . 3-10, 3-18
CHECK EXH VALVE alarm message . . . . . . . . . . . . . . . . . . . . . . . 3-10, 3-19
CHECK EXH VALVE PRESSURE alarm message . . . . . . . . . . . . 3-10, 3-19
CHECK FIO2 SENSOR alarm message . . . . . . . . . . . . . . . . . . . . 3-10, 3-19
CHECK PROXIMAL LINE1 alarm message . . . . . . . . . . . . . . . . . 3-10, 3-19
CHECK REMOTE ALARM alarm message . . . . . . . . . . . . . . . . . 3-10, 3-19
CHECK SETTINGS alarm message . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-19
troubleshooting a failed check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Cleaning
CONNECT VALVE OR CHANGE PRESS alarm message . . . . . 3-11, 3-20
Connecting to
Consumables, replacement intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Contraindications against use of ventilator . . . . . . . . . . . . . . . . . . . . . 2-2
CONTROLLED CYCLES alarm message . . . . . . . . . . . . . . . . . . . 3-11, 3-20
COOLING FAN alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
D
DC power cable
connecting to ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
disconnecting from ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
DC POWER DISCONNECTION alarm message . . . . . . . . 3-11, 3-20, 4-8
DEVICE FAULT10 alarm message . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
DEVICE FAULT11 alarm message . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
DEVICE FAULT12 alarm message . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 3-20
DEVICE FAULT13 alarm message . . . . . . . . . . . . . . . . . . . . . . . . 3-12, 3-21
DEVICE FAULT3 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
DEVICE FAULT5 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
DEVICE FAULT7 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
DEVICE FAULT9 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-11, 3-20
Dual Bag, fitting the ventilator into . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23
E
E SENS FAULT OR CIRC LEAK alarm message . . . . . . . . . . . . . 3-12, 3-21
Electromagnetic emissions and use of accessories . . . . . . . . . . . . . A-10
Electromagnetic emsissions and use of accessories . . . . . . . . . . . . . 4-2
EMPTY BATTERY alarm message . . . . . . . . . . . . . . . . . . . . 3-12, 3-21, 6-4
Environment, suitability for use of ventilator . . . . . . . . . . . . . . . . . . . . 2-1
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8
EXH VALVE LEAKAGE alarm message . . . . . . . . . . . . . . . . . . . . .3-12, 3-21
F
FIO2 SENSOR MISSING alarm message . . . . . . . . . . . . . . . . . . .3-12, 3-21
H
Heat safety device, battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7, 4-2
HIGH FIO2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-22
HIGH INT TEMP COOL VENT alarm message . . . . . . . . . . . . . .3-12, 3-23
HIGH LEAKAGE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . .3-12, 3-24
HIGH PRESSURE alarm message . . . . . . . . . . . . . . . . . . . . . . . . .3-13, 3-25
HIGH RATE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13, 3-25
HIGH VTE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13, 3-25
HIGH VTI alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13, 3-26
HIGH/LOW BATTERY TEMP alarm message . . . . . . . . . . . . . . .3-12, 3-24
I
Indicator and alarm specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Indicators
INTERNAL BATTERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3, 6-5
INSP FLOW alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13, 3-26
INTENTIONAL VENT STOP alarm message . . . . . . . . . . . . . . . .3-13, 3-26
Internal battery
charging (Warning) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2, 6-5
maintenance (none required) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
INTERNAL BATTERY indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
K
Key, VENTILATION ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
IN-2
Index
KEYPAD FAULT alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13, 3-26
L
Liquids, avoiding ingress into ventilator (Warning) . . . . . . . . . . . . . . 1-5
LOW BATTERY alarm message . . . . . . . . . . . . . . . . . . 1-7, 3-14, 3-26, 6-4
LOW FIO2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14, 3-27
LOW VTE alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14, 3-27
LOW VTl alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14, 3-28
M
Maintenance schedule, recommended . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Manufacturer’s declaration specifications . . . . . . . . . . . . . . . . . . . . . A-10
Menu
Monitored parameters
N
NO DATA message, Alarm Logs screen . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
NO PROXIMAL LINE2 alarm message . . . . . . . . . . . . . . . . . . . . .3-14, 3-28
Nurse call system, connecting the cable to the ventilator . . . . . . 4-27
O
OCCLUSION CHECK CIRCUIT alarm message . . . . . . . . . . . . .3-14, 3-28
Operational verification checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Operator/Users, targeted for use of ventilator . . . . . . . . . . . . . . . . . . 2-2
O-ring, oxygen coupler (Caution) . . . . . . . . . . . . . . . . . . . . . . . .1-18, 4-21
Oxygen
connecting the supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
connector stud . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18, 4-21
disconnecting the supply from the ventilator . . . . . . . . . . . . . . . 4-21
special coupler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18, 4-20, 4-21
using medical-grade only (Warning) . . . . . . . . . . . . . . . . . .1-18, 4-20
P
double limb, connecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
length and internal volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
single limb, connecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
PATIENT DISCONNECTION alarm message . . . . . . . . . . . . . . . .3-15, 3-28
Patients targeted for use of ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
POWER FAULT alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-28
POWER SUPPLY LOSS alarm message . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
Precautions for use, cautions
Precautions for use, warnings
PRES SENS FLT1 alarm message . . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
PROX SENS FLT2 alarm message . . . . . . . . . . . . . . . . . . . . . . . . 3-15, 3-29
R
Range, resolution, and accuracy specifications . . . . . . . . . . . . . . . . . .A-4
rear panel connector (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
Recharging the internal battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
REMOVE VALVE CPAP MODE alarm message . . . . . . . . . . . . . 3-15, 3-29
REMOVE VALVE OR CHANGE PRES alarm message . . . . . . . . 3-15, 3-29
Repairing the ventilator, qualified personnel only (Warning) .8-1, 8-3
Replacement intervals
S
Safety, onboard alarm system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Service assistance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
SOFTWARE VERSION ERROR alarm message . . . . . . . . . . . . . 3-16, 3-29
Specifications
manufacturer’s declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10
monitored parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
range, resolution, and accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
standards compliance and IEC classification . . . . . . . . . . . . . . . . A-15
Standards, compliance, and IEC classification specifications . . . . A-15
Stud, oxygen connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18, 4-21
T
IN-3
Transfer continuously, USB Memory Device . . . . . . . . . . . . . . . . . . . . . 5-5
Transfer Trends USB Memory Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Transport, emergency, ventilator not intended for . . . . . . . . . . . . . . . 2-2
Troubleshooting
TURB OVERHEAT alarm message . . . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
U
UNKNOWN BATTERY alarm message . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
Unpacking and preparing the ventilator . . . . . . . . . . . . . . . . . . . . . . . D-1
USB Memory Device
USB Menu parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Utility cart, mounting the ventilator onto . . . . . . . . . . . . . . . . . . . . . .4-26
V
VALVE MISSING CONNECT VALVE alarm message . . . . . . . . . 3-16, 3-29
Ventilation
VENTILATION ON/OFF key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Ventilator
connecting the nurse call cable . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27
connections, proper (warning) . . . . . . . . . . . . . . . . . . . . . 1-5, 4-2, 4-9
fitting into the Dual Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23
mounting on a wheelchair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-24
mounting onto a utility cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26
potentially hot surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11
symbols and markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
unpacking and preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Ventilator and liquid ingress (Warning) . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
VTI NOT REACHED alarm message . . . . . . . . . . . . . . . . . . . . . . 3-16, 3-29
W
Warnings
Welcome Menu screen
Wheelchair, mounting the ventilator onto . . . . . . . . . . . . . . . . . . . . .4-24
IN-4
Part No. 10066883 Rev E 2017-05
© 201
1
Covidien.
Covidien llc
15 Hampshire Street, Mansfield, MA 02048 USA
Covidien Ireland Limited, IDA Business and Technology ParkTullamore.
www.covidien.com [T] 1 800 635 5267

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