Users Manual
146 Pages
Preview
Page 1
Copyright information Copyright 2009 Nellcor Puritan Bennett LLC. All rights reserved. Puritan Bennett 540™ is a trademark of Nellcor Puritan Bennett LLC and/or its affiliates. COVIDIEN, COVIDIEN with Logo and ™ marked brands are trademarks of Covidien AG or an affiliate. The information contained in this manual is the sole property of Nellcor Puritan Bennett LLC and may not be duplicated without permission. This manual may be revised or replaced by Nellcor Puritan Bennett LLC at any time and without notice. You should ensure that you have the most current applicable version of this manual; if in doubt, contact Puritan Bennett’s Technical Support department or visit the Puritan Bennett product manual web page at: http://www.puritanbennett.com/serv/manuals.aspx While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The ventilator should be operated and serviced only by trained professionals. Nellcor Puritan Bennett LLC’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 Nellcor Puritan Bennett LLC’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, Nellcor Puritan Bennett LLC has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.
Contents Preface...
Preface–1
1 Safety Information... 1.1 1.2 1.3 1.4 1.5
1–1 Definitions... 1–1 Warnings... 1–2 Cautions... 1–9 Symbols and Markings... 1–10 Labels / Identification and Instruction Information... 1–14
2 Ventilator Overview... 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11
Indications for Use... Contraindications... Operational Use... Device Classification... Front Panel... Back Panel... Control Panel... Ventilation Menu... Alarm Menu... Waveforms Menu... If Ventilator Failure Occurs...
3 Alarms and Troubleshooting... 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8
Alarm Level of Priority... Alarm Display... Alarm Logs Menu... Silencing the Audible Portion of Alarms... Resetting/Pausing Alarms... Re-activating Alarms... Overview of Alarms... Troubleshooting... 3.8.1 Alarms... 3.8.2 Other Problems...
4 Installation and Assembly... 4.1 4.2 4.3
Installing the Ventilator... Connecting to External AC Power... Connecting to an External DC Power Source...
Puritan Bennett 540™ Ventilator User’s Manual
2–1 2–1 2–1 2–2 2–2 2–3 2–4 2–5 2–7 2–8 2–9 2–9 3–1 3–1 3–2 3–3 3–4 3–5 3–6 3–7 3–14 3–14 3–23 4–1 4–1 4–2 4–5
iii
Contents
4.4
Patient Circuit... 4.4.1 Choosing the Patient Circuit Type... 4.4.2 Installing the Patient Circuit... 4.5 Filters... 4.6 Humidifier... 4.7 Exhalation Block... 4.8 Oxygen... 4.8.1 Administering Oxygen... 4.8.2 Connecting the Oxygen Supply... 4.9 Mounting the Ventilator on a Wheelchair... 4.10 Mounting the Ventilator on the Utility Cart... 4.11 Connecting the Nurse Call Cable...
4–6 4–7 4–7 4–10 4–11 4–12 4–13 4–13 4–14 4–16 4–17 4–18
5 Operating Procedures...
5–1 5–1 5–2 5–4 5–5
5.1 5.2 5.3 5.4
Turning on The Ventilator... Starting Ventilation... Stopping Ventilation... Turning Off the Ventilator...
6 Internal Battery... 6.1 6.2 6.3 6.4 6.5 6.6
Battery Capacity... Battery Operation... Testing the Battery... Recharging the Battery... Storing the Battery... Replacing the Battery...
7 Cleaning... 7.1 7.2
Cleaning the Ventilator... Cleaning the Accessories...
8 Routine Maintenance... 8.1 8.2 8.3
Replacing the Air Inlet Filter... Recommended Schedule of Maintenance... Service Assistance...
A Specifications... A.1 A.2 A.3 A.4
A.5 A.6 A.7 A.8
iv
Physical... Electrical... Indicators and Alarms... Performance... A.4.1 Specifications... A.4.2 Test Results... Monitored Parameters... Range, Resolution, and Accuracy... Environmental... Pneumatic...
6–1 6–1 6–2 6–4 6–4 6–5 6–6 7–1 7–1 7–2 8–1 8–1 8–2 8–3 A–1 A–1 A–1 A–2 A–3 A–3 A–3 A–4 A–5 A–12 A–12
Puritan Bennett 540™ Ventilator User’s Manual
Contents
A.9 Manufacturer’s Declaration... A.10 Standards Compliance and IEC Classification...
A–13 A–17
B Operational Verification Checklist...
B–1
C Unpacking and Preparation...
C–1
D Modes and Breath Types... Modes of Ventilation... D.1.1 Assist/Control (A/C) Modes... D.1.2 SIMV Modes... D.1.3 CPAP Mode... D.1.4 PSV/CPAP Mode...
D–1 D–1 D–1 D–1 D–1 D–2
E Parts and Accessories...
E–1
F Glossary...
F–1
D.1
Index...
Puritan Bennett 540™ Ventilator User’s Manual
Index–7
v
This page intentionally blank
Figures Figure 1-1. Locations of Labels – Top-Front View... Figure 1-2. Locations of Labels – Front-Left View... Figure 1-3. Location of Labels – Front-Right View... Figure 1-4. Location of Labels and Markings – Back-Left View... Figure 1-5. Location of Labels – Bottom-Front View... Figure 2-1. Front Panel... Figure 2-2. Back Panel... Figure 2-3. Control Panel... Figure 2-4. Ventilation Menu Display... Figure 2-5. Alarm Menu... Figure 2-6. Waveforms Menu... Figure 3-1. Alarm Displays... Figure 4-1. AC Power Cable Holder... Figure 4-2. Inserting the Power Cable Holder Into the Notch... Figure 4-3. Power Cable Connected to the Ventilator... Figure 4-4. Power Indicators... Figure 4-5. Connecting the Ventilator to an External DC Power Source... Figure 4-6. Connecting the DC Power Cable to the Ventilator... Figure 4-7. Single Limb Patient Circuit... Figure 4-8. Double Limb Patient Circuit... Figure 4-9. Close-up of Exhalation Valve Tube and Proximal Pressure Tube... Figure 4-10. Air Inlet Filter... Figure 4-11. Bacteria Filter... Figure 4-12. Humidifier... Figure 4-13. Removing the Exhalation Block... Figure 4-14. Rear Panel Oxygen Connector... Figure 4-15. Connecting the Oxygen Supply System... Figure 4-16. Disconnecting the Oxygen Supply System... Figure 4-17. Using the Dual Bag Accessory... Figure 4-18. Connecting the Nurse Call Cable... Figure 5-1. Turning on the Ventilator... Figure 5-2. Welcome Menu Screen... Figure 5-3. Prompt to Start Ventilation... Figure 5-4. Starting Ventilation... Figure 6-1. Internal Battery Indicator... Figure 6-2. Power Indicators When Charging the Battery... Figure 6-3. Replacing the Battery... Figure 8-1. Replacing the Air Inlet Filter... Figure C-1. Puritan Bennett 540™ Portable Ventilator... Figure C-2. Dual Bag...
Puritan Bennett 540™ Ventilator User’s Manual
1–16 1–17 1–17 1–18 1–19 2–3 2–4 2–6 2–7 2–8 2–9 3–2 4–2 4–3 4–3 4–4 4–5 4–6 4–8 4–9 4–9 4–11 4–11 4–12 4–13 4–14 4–15 4–15 4–17 4–18 5–1 5–2 5–3 5–4 6–3 6–5 6–6 8–2 C–2 C–3
vii
This page intentionally blank
Tables Table 1-1. Ventilator Symbols... Table 1-2. Ventilator Labels and Markings... Table 3-1. Overview of Alarms... Table 3-2. Alarms and Corrective Actions... Table 3-3. Additional Problems and Corrective Actions... Table 7-1. Approved Cleaning Solutions for Exterior Ventilator Surfaces... Table 8-1. Consumables and Replacement Intervals... Table A-1. Physical Description (Excluding Accessories)... Table A-2. AC Electrical Supply... Table A-3. Internal Lithium Ion Battery... Table A-4. Remote Alarm... Table A-5. Power Indicators... Table A-6. Alarm Indicators... Table A-7. Audio Alarms... Table A-8. Performance Parameter Specifications and Tolerances... Table A-9. Volume Performance Test Results... Table A-10. Monitored Parameter Specifications and Tolerances... Table A-11. Ventilator Range, Resolution, and Accuracy... Table A-12. Environmental Conditions for Storage or Transport... Table A-13. Environmental Conditions for Operation... Table A-14. Airway Resistances... Table A-15. Patient Circuit Resistances... Table A-16. Air Inlet Resistance (Filter)... Table A-17. Oxygen Inlet Specifications... Table A-18. Performance Specifications... Table A-19. Electromagnetic Emissions... Table A-20. Electromagnetic Immunity... Table A-21. Electromagnetic Immunity – Conducted and Radiated RF... Table A-22. Recommended Separation Distances... Table A-23. Compliant Cables and Accessories... Table B-1. Operational Verification Checklist... Table E-1. List of Consumables and Accessories... Table E-2. List of Circuits...
Puritan Bennett 540™ Ventilator User’s Manual
1–10 1–14 3–7 3–14 3–23 7–1 8–2 A–1 A–1 A–2 A–2 A–3 A–3 A–3 A–3 A–3 A–4 A–5 A–12 A–12 A–12 A–12 A–12 A–12 A–13 A–13 A–14 A–15 A–16 A–16 B–1 E–1 E–2
ix
This page intentionally blank
Preface Purpose of This Manual This manual contains important information regarding the safe operation of your Puritan Bennett 540™ Ventilator. Your ventilator is an electrical device that can provide years of useful service with the proper care, as described in this manual. Ensure that you read and understand the instructions contained in this manual before operating the ventilator. WARNING Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter 1, “Safety Information”.
Qualification of Personnel Installation and maintenance of the device must be made by authorized and trained personnel. In particular, training for the handling of products sensitive to electrostatic discharges must include the use of Electrostatic Discharge (ESD) protection devices and knowledge of the following symbol’s meaning: , as well as using original spare parts and respecting quality assurance and traceability rules approved by Puritan Bennett.
Warranty Information regarding your product warranty is available from your sales representative or Puritan Bennett.
Extended Service The Puritan Bennett 540™ Portable Ventilator offers extended service contracts/warranties for purchase when the ventilator is purchased. Please contact your local Covidien/Puritan Bennett Sales or Service Representative for additional information.
Puritan Bennett 540™ Ventilator User’s Manual
Preface-1
Preface
For online technical support, visit the SolvITSM Center Knowledge Base by clicking the link at http://www.puritanbennett.com. Here, you will find answers to frequently asked questions about the Puritan Bennett 540™ Ventilator and other Puritan Bennett products 24 hours a day, 7 days a week. If you require further assistance, contact your local Puritan Bennett representative or call Puritan Bennett Technical Support at 1.800.255.6774.
Preface-2
Puritan Bennett 540™ Ventilator User’s Manual
1 Safety Information 1.1
Definitions This manual uses three indicators to highlight critical information: Warning, Caution, and Note. They are
defined as follows: WARNING Indicates a condition that can endanger the patient or the ventilator operator.
Caution Indicates a condition that can damage the equipment.
Note: Indicates points of particular emphasis, that make operation of the ventilator more efficient or convenient. It is essential to read, understand and follow these instructions before using the Puritan Bennett 540™ Ventilator. In order to use the ventilator correctly and efficiently and to help prevent incidents, please pay particular attention to sections 1.2, “Warnings” and 1.3, “Cautions” as well as all warnings and cautions contained throughout this manual.
Puritan Bennett 540™ Ventilator User’s Manual
1-1
Safety Information
1.2
Warnings General Precautions For Use WARNING • Federal law restricts this device to sale by or on the order of a licensed physician.
• The ventilator must be used only under the responsibility and on the prescription of a doctor. • The ventilator must be used according to its intended use. Refer to section 2.1, “Indications for Use”. • Be aware this manual describes how to respond to ventilator alarms, but it does NOT tell you how to respond to the patient.
• While the ventilator is in use, an alternative means of ventilation should always be available in the event of a ventilator problem. This is particularly true for ventilator-dependent patients. Supplementary observation, appropriate for the patient's condition, is also recommended.
• To ensure that ventilation continues uninterrupted, ensure alternative power sources are available (AC power source, extra batteries, or an auxiliary DC car adapter). Be prepared for the possibility of power failure by having an alternative means of ventilation ready for use-particularly for ventilatordependent patients.
• Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.
• The ventilator must not be used with flammable anesthetic substances. • Do not start ventilation until you ensure that the device is suitably assembled, that the air inlet filter is properly installed and is not obstructed, and that there is proper clearance all around the unit. Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient circuit, including all hoses, is not damaged or obstructed.
• You must start the ventilator and allow it to complete one full breath cycle prior to connecting the patient. Do not connect the patient before this cycle completes.
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated occasionally while powered by its internal battery. Ensure that the internal battery never becomes fully discharged.
• A ventilator-dependent patient should always be monitored by trained and competent medical personnel. Ensure that the patient’s caregiver is able and prepared to take suitable action in the event the ventilator identifies an alarmed condition or experiences a problem.
• Before dispensing the ventilator to caregivers or the patient for home use, ensure the Locking Key is activated so that critical ventilator settings are not modified.
• Do not perform ventilator alarm tests while the patient is connected to the ventilator. • Verify the functionality of the alarms conditions before connecting the patient to the ventilator. • 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 Puritan Bennett.
• When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.
• A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, the ventilation will resume without having to press the VENTILATION ON/OFF button.
• To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.
• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet-or both ports if a double-limb circuit is used-is recommended. Refer to chapter 7, “Cleaning”.
• Handle the ventilator with care during and after use, particularly when room temperatures are high. Some ventilator surfaces may become hot, even if safety specifications are not exceeded.
1-2
Puritan Bennett 540™ Ventilator User’s Manual
Warnings
General Precautions For Installation WARNING Environment:
• Because the internal Lithium-ion battery of the Puritan Bennett 540™ Ventilator contains more than 8g (equivalent) lithium and has a power-rating greater than 100 Wh (watt-hour), it is categorized as Hazardous Material (Dangerous Good), Class 9- Miscellaneous, even though the ventilator meets current safety standards. The ventilator, because of this categorization, is subject to strict transport conditions under the US Department of Transportation (US DOT) regulations for the transport of hazardous materials (49 CFR 173.185). As US DOT regulations cover commercial transportation only, there are two groups that can be exempted from these regulations. The first group consists of private individuals, providing that the goods are for their own personal use and measures have been taken to prevent leakage. The second group consists of persons that transport the goods because they need the product to execute their job(s). The later group is able to carry/transport certain hazardous materials, such as the Puritan Bennett 540™ Ventilator and the associated Lithium-ion battery(ies), under the established Materials of Trade (MOT) provisions detailed in 49 CFR 173.6. For any other group or purpose, transport must be compliant with the applicable Hazardous Materials/Dangerous Goods regulations specific to the origin/destination and mode of transport. Air transport of the Puritan Bennett 540™ Ventilator in only allowed as carry-on baggage, which may include up to two (2) individually packaged spare Lithium-ion batteries (it is recommended that users verify specific requirements/limitations with the airline carriers as to which measures to take before the voyage).
• Even though the Puritan Bennett 540™ Ventilator meets current safety standards, the internal Lithiumion battery of this device contains more than 8g equivalent lithium and exceeds a power-rating of 100 Wh (watt-hour) and therefore considered to be a Hazardous Material (Dangerous Good), Class 9 Miscellaneous when transported in commerce. As such, the Puritan Bennett 540™ Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions established by the US Department of Transportation (49 CFR 173.185) as well as other international transportation regulations. This classification and regulatory requirements may vary depending upon the country and mode of transport. In addition, air transport of the Puritan Bennett 540™ Ventilator is only allowed as carry-on baggage, which may include up to two (2) individually packaged spare Lithium-ion batteries. (it is recommended that users verify specific requirements/limitations with the airline carriers as to which measures to take before the voyage).
• To minimize the risk of damage, you must use the ventilator Dual Bag to transport the ventilator. • The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately.
• To avoid damage to the ventilator, fluids must not be allowed to enter the device, particularly through the air inlet filter or the cooling apertures located in the side, rear, and bottom panels of the ventilator.
• To ensure correct and lasting operation of the device, ensure that the ventilator is installed and operated in the environmental conditions recommended in Appendix A, “Specifications.”
• Do not operate the ventilator in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device.
• Ensure that the ventilator’s immediate surroundings allow for the proper operational connection of the device without folding, pinching, or damaging any of the required cables or tubes, and that the connection of the patient circuit to the patient provides for a secure, comfortable fit.
• Do not place the ventilator in a position where a child can reach it or in any position that might cause it to fall on the patient or someone else.
• To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes (main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains.
• If the ventilator has been transported or stored at a temperature that differs more than ± 36 °F (±20 °C) from the temperature in which it will be operating, the ventilator should be allowed to stabilize in its operating environment for at least two (2) hours prior to use.
Puritan Bennett 540™ Ventilator User’s Manual
1-3
Safety Information
WARNING Environment (Cont’d):
• If the room temperature where the device is operated is greater than 95 °F (35 °C), the flow supplied at the device outlet may exceed 106 °F (41 °C). This may lead to undesirable side effects for the patient. To avoid injury to the patient move the patient and the ventilator to a cooler location. For more information, contact Puritan Bennett.
• The default setting for altitude compensation is YES. Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations.
• To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (such as flammable anesthetics and/or heaters) away from the ventilator and oxygen hoses.
• If the ambient temperature is above 104 °F (40 °C), the battery's thermal cut-off circuit may prevent the battery from recharging fully-even if the INTERNAL BAT charging indicator indicates the battery is completely recharged.
• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary, replace the filter before the recommended replacement period is over (see chapter 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.
• Handle the ventilator with care during and after use, particularly when room temperatures are high. Some ventilator surfaces may become hot, even if safety specifications are not exceeded. Electrical Power Supplies:
• Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off.
• For the AC (“mains”) power cable to be properly secured, the attachment located on the power cable must be fitted into the power cable holder incorporated in the battery access cover and located under the AC (mains) power socket. Refer to section 4.2, “Connecting to External AC Power”.
• The power supply to which the ventilator is connected (both AC and DC) must comply with all applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear of the ventilator to ensure correct operation. Refer also to the electrical specifications found in Appendix A, “Specifications”.
• Ensure that the ventilator’s internal battery is fully charged before connecting the ventilator to an external DC power source. Powering the ventilator using an external 12– 30 VDC power source (via the DC power cable) does not enable charging of its internal battery.
• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated occasionally while powered by its internal battery. Ensure that the internal battery never becomes fully discharged.
• When using a car auxiliary adapter (cigarette lighter) ensure the car has been started prior to plugging in the ventilator’s DC adapter.
• Even if the “INTERNAL BAT“ indicator is off, charge of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 104 °F (40 °C). This is due to the characteristics of the battery’s internal heat safety device.
• When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.
•
When replacing the ventilator’s internal battery, the ventilator must be disconnected from all external power supplies and turned off.
• Batteries should be disposed of according to environmental legislation in your country and locality. • Never expose any batteries to direct flame. • Never touch the ventilator’s internal components, including the battery, and the patient simultaneously.
1-4
Puritan Bennett 540™ Ventilator User’s Manual
Warnings
WARNING
Hoses and Accessories:
• The ventilator must not use, nor be connected to, any anti-static or electrically conductive hoses, tubing, or conduits. High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation.
• During invasive ventilation (when an artificial airway bypasses the patient’s upper respiratory system), the patient’s upper respiratory system cannot humidify the incoming air. For this reason, the use of a humidifier, to minimize drying of the patient’s airways and subsequent irritation and discomfort, must be used.
• If exhaled tidal volume or exhaled minute volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must be used in order to detect leaks. In this case, both the High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation.
• The patient circuit should always be positioned to avoid hindering the patient's movements, to prevent accidental disconnection, and to minimize the risk of patient strangulation.
• For pediatric use, ensure that the patient circuit type fits, and, in all respects, is suitable for use with a child. Use a pediatric circuit for patients that weigh under 53 lb. (23 kg). See Table E-2, List of Circuits, on page E-2, for a list of recommended patient circuits.
• Resistance of the exhalation valve and accessories (water traps, filters, and so on) must be as low as possible.
• Adding attachments to the ventilator breathing system can cause the pressure during exhalation at the patient connection port to increase.
• The exhalation valve must allow rapid discharge of the circuit pressure. Ensure that the exhalation valve is always clean and its evacuation aperture (exhaust port) is never obstructed.
• Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett 540™ Ventilator.
• Consult with your Customer Support representative before attempting to use a heated humidifier. • Always position a humidification device so that it is lower than both the ventilator and the patient. Use water traps, if necessary, to limit water in the patient circuit and periodically empty these water traps.
• If a heated humidifier is used, you should always monitor the temperature of the air delivered to the patient. Air delivered from the ventilator that becomes too hot may burn the patient's airway.
• Adding accessories to the ventilator breathing circuit, such as a humidifier and water trap(s), may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory. Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration.
• The level of inspiratory resistance of the circuit and accessories (bacteria filter, humidifier, and so on) must be as low as possible. Settings-particularly the LOW PRESSURE DISCONNECT alarm, High inspired volume (High VTI), and Low inspired volume (Low VTI) settings-must be periodically adjusted according to changes in the patient circuit resistance-especially when filters are replaced.
• To ensure proper performance of the ventilator, use a patient circuit recommended by Puritan Bennett in this manual; refer to chapter 4, “Installation and Assembly”. The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 3.6 feet (1.10 meters) to 6.6 feet (2.00 meters). The tubing must conform to all applicable standards and must be fitted with Ø 22 mm terminals that also conform to all applicable standards. Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume: a corrugated tube of Ø 22 mm for adult patients, and a corrugated tube of Ø 15 mm for pediatric patients with a tidal volume lower than 200 ml.
• When using non-invasive ventilation (niv), use a non-vented nose or face mask. • Before using the Nurse Call system, ensure that its connections are secure and it operates properly. For more information, contact Puritan Bennett.
Puritan Bennett 540™ Ventilator User’s Manual
1-5
Safety Information
Precautions Regarding Settings 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.
• Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of expiratory gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.
• Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. The audible alarm vents located at the front of the device should never be obstructed. The alarm can be paused with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared.
• Monitor the patient's state of health in order to ensure that the ventilator’s settings are always suited to the patient’s current physiological requirements.
• In the case of pediatric use, ensure that the adjusted tidal volume is compatible with the needs of the child.
• Ensure that the tidal volume setting in VC is compatible with the needs of the patient. • 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.
• If APNEA TIME is set to a value higher than 60/Control R then the APNEA alarm will not activate. • Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction. • Adjustable alarms should not be systematically cancelled; instead, they should be adjusted according to the needs and condition of the patient.
• A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, the ventilation will resume without having to press the VENTILATION ON/OFF button.
1-6
Puritan Bennett 540™ Ventilator User’s Manual
Warnings
Maintenance Precautions WARNING • Never use a ventilator or any components or accessories that appear to be damaged. If any signs of damage are evident, contact your equipment supplier or Puritan Bennett.
• If you cannot determine the cause of a problem with your ventilator, contact your equipment supplier. Do not use the ventilator until the problem has been corrected.
• Except for replacing the internal battery and cleaning the device, do not try to repair or otherwise service the ventilator yourself, or modify the ventilator, its components, or accessories. Doing so might endanger the patient, cause damage to the ventilator, and/or void your warranty. Only qualified service personnel should attempt repair of the ventilator.
• On a daily basis, ensure the proper connection and operation of the patient circuit. • If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER. If necessary, remove the patient from the ventilator and provide an alternative means of ventilation.
• After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.
• Use all cleaning solutions and products with caution. Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator. Use only those solutions listed in Table 7-1.
• Do not attempt to repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, and/or void your warranty. Only qualified service personnel should repair or service the ventilator.
• If the ventilator is damaged or its external housing is not correctly closed or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
• The exhalation block is intended for single use by a single patient. It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, trained personnel should clean the exhalation block periodically. The exhalation block should be changed every 3 months and cannot be reused with any other patient.
• Ensure that the exhalation block is completely dried after cleaning and prior to use. • When an exhalation block is set up, each time it is removed, or after installing a new exhalation block on the machine, it is essential that the expiratory flow sensor be recalibrated before the exhalation block is used; refer to section 10.1, “Calibrating the Expiratory Flow Sensor” in the Clinician’s Manual.
• The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer’s recommendations. Refer to the instructions for use supplied by the manufacturer of the patient circuit (included with the ventilator) and chapter 4, “Installation and Assembly”.
• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet-or both ports if a double-limb circuit is used-is recommended. Refer to chapter 7, “Cleaning”.
• When replacing the ventilator’s internal battery, the ventilator must be disconnected from all external power supplies and turned off.
• Never touch the ventilator’s internal components, including the battery, and the patient simultaneously.
• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary, replace the filter before the recommended replacement period is over (see section 10, “Routine Maintenance in the Clinician’s Manual). This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.
Puritan Bennett 540™ Ventilator User’s Manual
1-7
Safety Information
WARNING Maintenance Precautions (Cont’d):
• For environmental protection, the ventilator and its components, whatever their respective conditions of operation, cannot be disposed of with household waste and must be submitted for suitable selective collection and possible recycling. Observe all applicable regulations when disposing of the ventilator and any of its components.
• If the device is damaged, its external housing is not correctly closed, or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.
• After replacing the ventilator’s internal battery, push on the battery’s cover from the rear towards the front to take pressure off the cover mounting brackets, thereby avoiding breakage when the screws are tightened.
Precautions Regarding Oxygen WARNING
• The ventilator must not be used with flammable anesthetic substances. • Oxygen therapy for patients with respiratory failure is a common and effective medical prescription. However, be aware that excessive oxygen use is likely to lead to serious complications-including, but not limited to, patient injury.
• Strictly follow the instructions provided in section 4.8.2, “Connecting the Oxygen Supply”, which include the use of a flow regulator and special coupler.
• To avoid injury to the patient and/or possible damage to the ventilator: before using the ventilator, use a flow meter (flow regulator) to regulate the oxygen supply to specifications before connecting the ventilator to the oxygen supply.
• The Puritan Bennett 540™ Ventilator does not include an oxygen analyzer. Always measure the delivered oxygen with a calibrated oxygen analyzer that features a high and low concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.
• Ensure that the oxygen supply pressure to the machine never exceeds 7.25 psi (49.99 kPa) or a flow of 15 lpm. Refer to Table A-8 on page A-3 for volume and sensitivity tolerances.
• In the event of an oxygen leak, shut down the supply of oxygen at its source. In addition, remove and/or keep any incandescent source away from the device, which may be enriched with oxygen. Air the affected room to bring the oxygen level down to normal.
• The hose connecting the ventilator to the oxygen source must be designed exclusively for use with medical-grade oxygen. Under no circumstances should the oxygen hose be modified by the user. In addition, the hose must be installed without the use of lubricants.
• Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical-grade oxygen.
• The coupler must not remain connected to the oxygen connector unless it also connected to a leakproof, external oxygen gas source. When an oxygen supply is not being used with the ventilator, disconnect the oxygen source completely from the ventilator.
• To prevent any interference with the internal sensors of the ventilator, do not install a ventilator humidifier upstream of the ventilator.
1-8
Puritan Bennett 540™ Ventilator User’s Manual
Cautions
1.3
Cautions General Precautions For Use Caution • To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator, only qualified personnel should attempt to service the Puritan Bennett 540™ Portable Ventilator.
General Precautions For Installation Caution Environment:
•
Avoid using the ventilator, if possible, in dusty environments. Dusty environments may require more vigilant monitoring, cleaning, and/or replacement of air intake and other filters.
Electrical Power Supplies:
• •
Before using the ventilator’s internal battery, ensure that the battery is fully charged and that the charge holds.
•
To connect the ventilator to an external power source, first ensure the ventilator’s I/O switch is off (O). Then, connect the desired power cable to the ventilator. Finally, connect the power cable to the external power source.
•
To disconnect the ventilator from an external power source, first power-down the ventilator. Then, disconnect the power cable from the external power source and, finally, the ventilator.
• • •
Do not leave power cables lying on the ground where they may pose a hazard.
Do not store the internal battery, either installed within or removed from the ventilator, for more than two (2) years.
Ensure that the AC power cable is in perfect condition and not compressed. To connect the ventilator to a Nurse Call device, contact Puritan Bennett to check the ventilator's compatibility with the Nurse Call device and order a suitable connection cable. Do not use Nurse Call devices that operate based on the closure of an electrical circuit, because the devices often do not take into account possible cable disconnection or a total loss of power. Ensure that the Nurse Call device is always connected to the ventilator.
Caution Hoses and Accessories:
•
Before opening the packaging for the Patient Circuit, ensure that no damage is evident to the packaging or its contents. If evidence of damage exists, contact your supplier.
Maintenance Precautions Caution Before cleaning the ventilator, first disconnect the ventilator and the circuit.
• •
Never use a liquid cleaner inside the patient circuit, or on any component of a gas pathway. Clean the patient circuit only as specified by the manufacturer's instructions.
•
If the ventilator is used indoors, the condition of the air inlet filter should be checked monthly. If the ventilator is used outdoors or in a dusty environment, the filter should be checked weekly and replaced as necessary.
• •
The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.
•
Except for changing the battery (as required by qualified technicians or the Clinician), do not attempt to open the ventilator’s enclosure. Doing so might result in damage to the device and/or may void your warranty.
Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause serious damage to the ventilator.
Puritan Bennett 540™ Ventilator User’s Manual
1-9