Puritan bennett руководство

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  User Manual Puritan Bennett 560 Ventilator…
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  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…

• Page 3: Table Of Contents

  Table of Contents Preface Purpose of This Manual …………xi Qualification of Personnel .

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  Table of Contents 2.11 USB Memory Device Menu ……….2-11 2.12 If Ventilator Failure Occurs .
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  Table of Contents Operating Procedures Turning on the Ventilator ……….. 5-1 USB Menu Parameters .
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  Table of Contents Indicators and Alarms …………A-2 Performance .
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  List of Figures Figure 1-1.   Locations of Labels—Top-Front View ……….. . 1-25 Figure 1-2.  …
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  List of Figures Figure 4-24.   Mounting the Ventilator on the Utility Cart……….4-29 Figure 4-25.  …
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  List of Tables Table 1-1.   Ventilator Symbols …………..1-19 Table 1-2.  …
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  Page Left Intentionally Blank…

• Page 11: Purpose Of This Manual

  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 addi- tional information.

• Page 12: Service Centers

  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.

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  Service Centers Covidien France SAS Covidien Hong Kong Covidien ECE s.r.o. Covidien India C-Mill Gebouw K Unit 12 — 16, 18/F Magyarországi Fióktelepe 10th Floor Building No 9B Jan Campertstraat 21-A BEA Tower Mariássy u.7. DLF Cyber City Phase III Gurgaon…
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  Preface Covidien Spain S.L. Covidien Sverige AB Covidien Switzerland Covidien Thailand C-Mill Gebouw K C-Mill Gebouw K C-Mill Gebouw K 99 Soi Rubia Jan Campertstraat 21-A Jan Campertstraat 21-A Jan Campertstraat 21-A Sukhumvit 42 Road 6416 SG Heerlen, Netherlands 6416 SG Heerlen, Netherlands 6416 SG Heerlen, Netherlands 13-14 Fl., Berli Jucker Building…

• Page 15: Safety Information

  1 Safety Information 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 con- venient.

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  Safety Information WARNING: The ventilator must be used according to its intended use. Refer to section 2.1, Indications for Use. WARNING: Be aware this manual describes how to respond to the ventilator, but does not tell you how to respond to the patient.
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  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.

• Page 18: Warnings Regarding Installation And Environment Of Use

  Safety Information WARNING: Do not connect the ventilator to any device other than a PC with a dedicated compatible Puritan Bennett™ software package. WARNING: The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of conditions.

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  Warnings 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 A, Specifications.
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  60°C (140°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.

• Page 21: Warnings Regarding Electrical Power Supplies

  Warnings WARNING: Exercise care to avoid any potential significant risks of reciprocal interference posed by the ventilator and accessories during specific investigations or treatments. Warnings Regarding Electrical Power Supplies 1.2.3 WARNING: The operator should connect the ventilator to an AC power source whenever available, for safer operation.

• Page 22: Warnings Regarding Hoses And Accessories

  Safety Information 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.

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  Warnings WARNING: The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically (refer to section 7.3, Cleaning the Exhalation Block).
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  (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…

• Page 25: Warnings Regarding Settings

  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.

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  Safety Information WARNING: Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths. WARNING: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient, based on clinical judgment, the condition and needs of the patient, and the benefits, limitations, and characteristics of the breath delivery options.
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  Warnings WARNING: The Apnea alarm should be set to YES for ventilator dependent patients. WARNING: Setting any alarm limits to OFF or 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 clinician to situations that may require intervention.

• Page 28: Warnings Regarding Pc Connection And Usb Memory Devices

  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.

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  Do not attempt to open, repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, or void your warranty. Only personnel authorized and qualified by Covidien should repair, open or service the ventilator. WARNING:…
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  Safety Information 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.

• Page 31: Warnings Regarding Oxygen

  Warnings 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. Warnings Regarding Oxygen 1.2.8 WARNING: The ventilator must not be used with flammable anesthetic substances.

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  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.

• Page 33: Warnings Regarding Electromagnetic Interference

  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…

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  Safety Information Table 1-1.  Ventilator Symbols (Continued) Symbols Descriptions 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 in Table 1-2.  …
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  Symbols and Markings Table 1-1.  Ventilator Symbols (Continued) Symbols Descriptions Exhalation valve pilot port. This symbol appears on the front right of the ventilator, adjacent to the exhalation valve and TO PATIENT ports, indicating the connection of the tubing between the patient circuit exhalation valve; see Figure 1-1, and item 3 in Figure 1-4.  …
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  Safety Information Table 1-1.  Ventilator Symbols (Continued) Symbols Descriptions 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 Pref- erences menu.
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  Table 1-1.  Ventilator Symbols (Continued) Symbols Descriptions PC connection. This symbol indicates a port that can be used by authorized Covidien product service personnel or Covidien service personnel for software maintenance. See item 10 in Figure 1-3.   Atmospheric pressure limitations. See section for specifications.

• Page 38: Labels (Identification And Instruction Information)

  Safety Information 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 Table and the figures on the following pages for illustrations of these labels and markings and their loca- tions on the ventilator.

• Page 39: Figure 1-1. Locations Of Labels-Top-Front View

  Labels (Identification and Instruction Information) Note: The item number callouts in the following figures correspond to those listed in Table 1-2.   Figure 1-1.  Locations of Labels—Top-Front View Figure 1-2.  Locations of Labels—Front-Left View User Manual 1-25…

• Page 40: Figure 1-3. Location Of Labels And Markings-Rear View

  Safety Information Figure 1-3.  Location of Labels and Markings—Rear View Figure 1-4.  Location of Labels—Bottom View 1-26 User Manual…

• Page 41: Ventilator Overview

  2 Ventilator Overview 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.

• Page 42: Target Operators

  Ventilator Overview 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.

• Page 43: Operational Use

  Operational Use 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;…

• Page 44: Device Classification

  Ventilator Overview WARNING: Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett™ 560 ventilator. Device Classification The ventilator’s IEC/EN 60601-1classification is as follows: Protection/insulation class (electric shock): Class II • Protection index of enclosure: IP32 •…

• Page 45: Front Panel

  Front Panel Front Panel Figure 2-1.  Front Panel LCD display—Shows information about the ventilator, including Exhalation valve port—Nipple for providing piloting patient hours and software version, ventilation modes and settings, pressure to the exhalation valve. Controls the open-closed and monitored and calculated patient data and waveforms. The position of the exhalation valve.

• Page 46: Back Panel

  Ventilator Overview Back Panel Figure 2-2.  Back Panel Ergonomic carrying handle. PC cable connector: USB mini-B connector used for Puritan Bennett™ ventilator test software. WARNING: Do not connect the ventilator to any device other than a PC with a dedicated compatible Puritan Bennett™ soft- ware package.

• Page 47: Control Panel

  Control Panel Control Panel Figure 2-3.  Control Panel Alarm indicators (two LEDs): DOWN/FREEZE key: Red indicator: • Moves the cursor down and decreases parameter values. • Continuous: Very high priority (VHP) alarm activated. • During ventilation, freezes the waveform shown in the Wave- form menu.

• Page 48: Ventilation Menu

  Ventilator Overview Ventilation Menu Figure 2-4.  Ventilation Menu Display (on standby at left; during ventilation at right) 1 General information line: 2 Ventilation settings: 3 Preferences menu access line: Shows the current ventilation mode, Shows the specific ventilation parameter Highlight this line and press the along with the following: values for the currently selected ventilation ENTER…

• Page 49: Alarm Menu

  Alarm Menu Alarm Menu Figure 2-5.  Alarm Menu (on standby at left; during ventilation at right) 1 Title line: 2 Alarm settings: 3 Access line to Alarm Logs menu. Shows ventilation mode and the follow- Shows the specific alarm parameter Highlight this line and press the ENTER ing symbols: values for the currently selected ventila- key to show the Alarm Logs menu.

• Page 50: Waveforms Menu

  Ventilator Overview Waveforms Menu 2.10 The display of waveforms (see Figure 2-6) is optional and can be selected using the Menu key. The Waveform menu is only accessible when ventilation is active. Figure 2-6.  Waveforms Menu 1 Title line: 2 Graphic zone: 3 Numeric zone: Shows ventilation mode and the follow- Shows the patient’s pressure and flow…

• Page 51: Usb Memory Device Menu

  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 8.7, Service Assistance.

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  Ventilator Overview Page Left Intentionally Blank 2-12 User Manual…

• Page 53: Alarms And Troubleshooting

  3 Alarms and Troubleshooting Overview The alarms or faults generated by the Puritan Bennett™ 560 ventilator are classified into two cat- egories: Ventilation (or utilization) alarms • Technical faults • Alarms indicate events likely to affect the ventilation in the short term and necessitate rapid inter- vention (see section 3.9, Troubleshooting).

• Page 54: Alarm Level Of Priority

  Alarms and Troubleshooting Note: Default alarm setting preferences should be entered prior to using the ventilator. 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. 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;…

• Page 55: Alarm Display

  Alarm Display Alarm Display Note: The alarm indicator LEDs to the left of the ALARM CONTROL key on the Puritan Bennett™ 560 ventilator are designed to be visible to the operator at any position where the ventilator is visible to the operator. Specific alarm detail (shown in the alarm message area) is designed to be readable from up to four meters from the screen, at a viewing angle of up to 30°.

• Page 56: Alarm Logs Menu

  Alarms and Troubleshooting 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;…

• Page 57: Figure 3-4. Alarm Logs Screen

  Alarm Logs Menu Figure 3-4.  Alarm Logs Screen Note: When no alarm has been activated, the message “NO DATA” is shown on the screen (see Figure 3-5). Figure 3-5.  Alarm Logs Screen (no alarm activated) For more information on the User’s clear alerts line, see section 3.7, Reactivating Alarms.

• Page 58: Pausing The Audible Portion Of Alarms

  Alarms and Troubleshooting Pausing the Audible Portion of Alarms WARNING: Do not pause, disable, or decrease the volume of the ventilator’s audible alarm if patient safety could be compromised. To pause the audible portion of activated alarms for 60 seconds at a time, press the ALARM CONTROL key.

• Page 59: Pausing And Resetting Alarms

  Pausing and Resetting Alarms Pausing and 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.

• Page 60: Reactivating Alarms

  Alarms and Troubleshooting Reactivating Alarms Alarms that have been paused and whose activation conditions continue to exist can be reactivated. To reactivate alarms, proceed as follows: Press the MENU key to access the alarm setting menu, if this is not the menu currently shown. Press the DOWN key to position the cursor on the Alarm Logs line, if this is not already the case.

• Page 61: Overview Of Alarms

  Overview of Alarms 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. • Overview of Alarms Note: The message: “*IF PERSISTS RESTART/SRVC”…

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  Alarms and Troubleshooting Table 3-1.  Overview of Alarms (Continued) Alarm message Cause/ventilator response Priority Audio Paused Alarm Paused available available BUZZER FAULT3 Battery charge failure due to incorrect voltage. Contact your service representative for assistance. RESTART/SRVC BUZZER LOW BATTERY Buzzer battery failure. The battery buzzer voltage is too low.
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  Overview of Alarms Table 3-1.  Overview of Alarms (Continued) Alarm message Cause/ventilator response Priority Audio Paused Alarm Paused available available CHECK SETTINGS Alarm activation occurs: • Systematically after software versions have changed. • Loss of memorized parameters Consequence: • Locking key disabled •…
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  Alarms and Troubleshooting Table 3-1.  Overview of Alarms (Continued) Alarm message Cause/ventilator response Priority Audio Paused Alarm Paused available available EMPTY BATTERY Internal battery capacity <10 minutes or 3%. (battery If AC power is voltage <22.5 V) not connected: Consequence: Ventilation comes to a halt. If AC power is connected: LP EXH VALVE LEAKAGE…
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  Overview of Alarms Table 3-1.  Overview of Alarms (Continued) Alarm message Cause/ventilator response Priority Audio Paused Alarm Paused available available INSP FLOW Inspiratory flow is constant (±1 lpm) with normal turbine temperature and speed conditions. Contact RESTART/SRVC your service representative for assistance. INTENTIONAL VENT STOP Ventilation has been stopped voluntarily by the care- giver or patient.
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  Alarms and Troubleshooting Table 3-1.  Overview of Alarms (Continued) Alarm message Cause/ventilator response Priority Audio Paused Alarm Paused available available PATIENT DISCONNECTION* Alarm activation occurs under the following condi- tions (time is in seconds): *IF PERSISTS RESTART/SRVC • Disconnection time or 60/R-Rate, whichever is great- er, in P A/C and V A/C mode •…

• Page 67: Troubleshooting

  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.

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  Alarms and Troubleshooting Table 3-2.  Alarms and Corrective Actions Alarm message or Possible reason for the alarm event Corrective action symptom AC POWER DISCONNECTION 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.
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  Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom CALIBRATION FAIL Too large a difference between a calibration point There may be a leak in the circuit. Ensure an approved and its tolerance range. circuit is in use (see circuit documentation).
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  Alarms and Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom CHECK PROXIMAL LINE1* No connection of the proximal pressure tube Reconnect the proximal pressure line. when ventilation starts. *IF PERSISTS RESTART/SRVC Note: The Check Proximal Proximal pressure line disconnected or obstruct- Reconnect the connection line or replace it if…
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  Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom DEVICE FAULT7 Internal technical problem. Restart ventilator to see if alarm clears. If not, replace the ventilator. Contact your customer service representa- IF PERSISTS RESTART/SRVC tive for assistance.
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  Alarms and Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom SENSOR MISSING There is no FiO sensor, and FiO alarms are active. Contact your customer service representative for assis- tance. HIGH FiO The level of oxygen being delivered to the patient Contact your customer service representative for assis-…
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  Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom HIGH LEAKAGE The leak estimated by the ventilator exceeds the Readjust mask to reduce leakage. Max Leak alarm threshold. Contact your customer service representative for addi- tional assistance.
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  Alarms and Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom HIGH VTI Adjustment of the Max VTI level too low (for PSV, Contact your customer service representative for assis- CPAP, P A/C, P SIMV, and V SIMV modes). tance.
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  Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom LOW VTE Patient circuit obstructed. Clean, unblock, or properly connect the patient circuit. Leak in the patient circuit. Check and properly connect the patient circuit connec- tions.
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  Alarms and Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom PATIENT DISCONNECTION Adjustment of Min PIP too high. Contact your customer service representative for assis- tance. *IF PERSISTS RESTART/SRVC Leak or loose connection in the patient circuit. Check the patient circuit connections to the ventilator;…

• Page 77: Additional Troubleshooting

  Troubleshooting Table 3-2.  Alarms and Corrective Actions (Continued) Alarm message or Possible reason for the alarm event Corrective action symptom VALVE MISSING CONNECT The ventilation settings are not compatible with Connect exhalation valve. VALVE the type of patient circuit used. VTI NOT REACHED Defective inspiratory flow sensor or internal leak of Restart ventilator to see if alarm clears.

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  Alarms and Troubleshooting Table 3-3.  Additional Troubleshooting and Corrective Actions (Continued) Conditions Possible causes Corrective actions Unusual display on the Problem with the display unit. Ensure that the ventilator is not exposed to direct screen radiation from the sun. Contact your customer service representative if the problem persists.

• Page 79: Installation And Assembly

  4 Installation and Assembly WARNING: Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter 1, Safety Information. 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.

• Page 80
  60°C (140°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.

• Page 81: Connecting To External Ac Power

  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…

• Page 82: Figure 4-1. The Power Cable Holder

  Installation and Assembly WARNING: Do not leave power cables lying on the ground where they may pose a hazard. To prevent accidental disconnection of the AC power cable, use the power cable holder that is inserted into the notch on the battery cover. See Figure 4-1. Figure 4-1.  The Power Cable Holder Power cable holder Notch on battery cover…

• Page 83: Figure 4-3. Power Cable Connected To The Ventilator

  Connecting to External AC Power Connect the female end of the ventilator’s AC power cable to the AC connector on the back of the ven- tilator. Figure 4-3.  Power Cable Connected to the Ventilator 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.

• Page 84: Connecting To An External Dc Power Source

  Installation and Assembly To disconnect the AC power cable: Disconnect the AC power cable from the AC power outlet. Disconnect the AC power cable from the ventilator’s AC connector at the rear of the device. 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.

• Page 85: Figure 4-5. Connecting The Dc Power Cable To The Ventilator

  Connecting to an External DC Power Source Figure 4-5.  Connecting the DC Power Cable to the Ventilator Red alignment dots Connector locking ring DC power cable connector To connect the DC power cable to the ventilator (see Figure 4-5): Line up the red alignment dots on the ventilator’s DC power receptacle and on the DC power cable. Push the DC power cable into the ventilator’s DC power receptacle.

• Page 86: Patient Circuit

  Installation and Assembly Connect the smaller connector on the DC power cable into the DC power input receptacle on the rear of the ventilator. Connect the larger connector on the DC power cable into the power source’s DC auxiliary receptacle. If connecting the ventilator to the Puritan Bennett™…

• Page 87: Choosing The Patient Circuit Type

  WARNING: To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this manual; refer to Chapter 4,…

• Page 88: Figure 4-7. Single-Limb Patient Circuit With Exhalation Valve (Including Accessories)

  Installation and Assembly Single-Limb Circuit (With Exhalation Valve) Figure 4-7.  Single-Limb Patient Circuit With Exhalation Valve (including accessories) Inspiratory bacteria filter Exhalation valve tubing Short circuit tubing Proximal pressure tubing Humidifier (optional accessory) Patient proximal pressure port Water trap Exhalation valve port Exhalation valve FROM PATIENT port Note:…

• Page 89: Figure 4-8. Closeup Of Exhalation Valve Tube And Proximal Pressure Tube

  Patient Circuit Connect the exhalation valve tubing to the exhalation valve port on the ventilator. See Figure for a detailed view. Figure 4-8.  Closeup of Exhalation Valve Tube and Proximal Pressure Tube TO PATIENT port Proximal pressure tube Exhalation valve tube Connect the inspiratory bacteria filter to the TO PATIENT outlet port on the ventilator. Connect one end of the short circuit tubing to the inspiratory bacteria filter.

• Page 90: Figure 4-9. Double-Limb Patient Circuit (Including Accessories)

  Installation and Assembly Double-Limb Circuit Figure 4-9.  Double-Limb Patient Circuit (including accessories) Inspiratory bacteria filter Exhalation valve tubing Humidifier (optional accessory) Exhalation valve assembly Water traps Exhalation (FROM PATIENT) port Short circuit tubing Exhalation bacteria filter Patient wye Patient proximal pressure port Proximal pressure tubing Exhalation valve port Double-limb circuit tubing…

• Page 91: Figure 4-10. Closeup Of Exhalation Valve Tube And Proximal Pressure Tube

  Patient Circuit Connect the proximal pressure tubing to the patient proximal pressure port on the ventilator. See Figure 4-10 for a detailed view. Connect the exhalation valve assembly to the exhaled gas outlet on the left side of the ventilator, near the left front corner.

• Page 92: Figure 4-11. Close-Up Of Exhalation Bacteria Filter Connection

  Installation and Assembly Using a circuit adapter, connect the exhalation bacterial filter to the FROM PATIENT inlet port. See Figure 4-11. Figure 4-11.  Close-up of Exhalation Bacteria Filter Connection Single-Limb Circuit (Without Exhalation Valve) Figure 4-12.  Single-Limb Patient Circuit Without Exhalation Valve Inspiratory bacteria filter Short circuit tubing Humidifier (optional accessory) Patient circuit tubing…

• Page 93
  Patient Circuit Connect the inspiratory bacteria filter to the TO PATIENT outlet port on the ventilator. Connect one end of the short circuit tubing to the inspiratory bacteria filter. Connect the other end of the short circuit tubing to the inlet port of the humidifier. If it is not already in place, connect a water trap to the outlet port of the humidifier and to the patient circuit tubing.

• Page 94: Filters

  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.

• Page 95: Bacteria Filter

  Filters WARNING: Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause serious damage to the ventilator. Bacteria Filter 4.5.2 It is highly recommended that you install a bacteria filter (see Figure 4-14) on both single- and double-limb circuits.

• Page 96: Humidifier

  Installation and Assembly Humidifier The humidifier (Figure 4-15) adds moisture (water vapor) and warms the gas in the patient circuit. It is inserted into the patient circuit between the TO PATIENT outlet port and the patient (see Figures 4-7, 4-9, and 4-12). Figure 4-15.  Humidifier WARNING: During invasive ventilation (when an artificial airway bypasses the patient’s upper respiratory system),…

• Page 97: Exhalation Block

  Exhalation Block See the humidification device’s instructions for information on operating, cleaning, and sterilizing the humidifier. Note: It is the user’s responsibility to verify that any humidification system selected for use is compatible with the Puritan Bennett™ 560 ventilator. Exhalation Block WARNING: The exhalation block is intended for single use by a single patient .

• Page 98: Oxygen

  Installation and Assembly Oxygen Administering Oxygen 4.8.1 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.

• Page 99: Connecting The Oxygen Supply

  Oxygen Connecting the Oxygen Supply 4.8.2 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.

• Page 100: Figure 4-18. Connecting The Oxygen Supply

  Installation and Assembly WARNING: Before connecting the oxygen supply, ensure that the stud on the oxygen inlet (Figure 4-17, item 3) is protruding outwards. WARNING: Inspect the oxygen coupler (Figure 4-17, item 2) before use to ensure it has its black O-ring (Figure 4-18, item 2) attached and in good condition.

• Page 101: Figure 4-19. Disconnecting The Oxygen Supply

  Oxygen Figure 4-19.  Disconnecting the Oxygen Supply Disconnect the oxygen supply by pulling the coupler out from the inlet port. The locking stud on the inlet port (Figure 4-18, 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.

• Page 102: Figure 4-20

  Installation and Assembly 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. Note: A clinician or medical professional should be present when calibrating the FiO sensor.

• Page 103: Using The Dual Bag

  Using the Dual Bag Using the Dual Bag The dual bag accessory allows the patient to carry the Puritan Bennett™ 560 ventilator on his or her back, and also allows it to be secured to the back of a wheelchair or to the seat of a personal vehicle. WARNING: Due to the internal battery’s limited reserve capacity, the ventilator should only be operated on the internal battery when no other power source is available.

• Page 104: Wearing The Dual Bag As A Backpack

  Installation and Assembly Slip the ventilator into the dual bag, front panel first. Push it in completely to ensure a snug fit. Shut the rear panel of the dual bag ensuring that the hook and loop fastener strips are securely fastened. If not mounting the dual bag on a wheelchair or in a personal vehicle, the patient circuit can be reconnected to the ventilator.

• Page 105: Figure 4-22

  Using the Dual Bag Figure 4-22.  Using the Dual Bag on a Wheelchair (with double-limb circuit on left; with single-limb circuit on right) To secure the dual bag onto a wheelchair with two push handles (see Figure 4-22): Facing the back of the wheelchair, loop each backpack strap over one of the push handles. Attach the nonadjustable side of the maintaining belt to the side clip of the dual bag.

• Page 106: Securing The Ventilator In A Personal Vehicle

  Installation and Assembly Securing the Ventilator in a Personal Vehicle 4.9.4 Figure 4-23.  Using the Dual Bag in a Personal Vehicle To secure the dual bag in a personal vehicle (see Figure 4-23): Unclip the two backpack straps from the side clips. Clip the suspension onto the central ring.

• Page 107: Mounting The Ventilator On A Utility Cart

  Mounting the Ventilator on a Utility Cart Mounting the Ventilator on a Utility Cart 4.10 As an alternative to using the dual bag for patient mobility, the Puritan Bennett™ 560 ventilator can be mounted on a utility cart. To mount the ventilator on the cart: Match the mounting holes on the bottom of the ventilator to the mounting studs on the top of the utility cart platform.

• Page 108: Figure 4-26. Puritan Bennett™ 560 Ventilator Mounted On Utility Cart

  Installation and Assembly Figure 4-26.  Puritan Bennett™ 560 Ventilator Mounted on Utility Cart 4-30 User Manual…

• Page 109: Operating Procedures

  5 Operating Procedures Turning on the Ventilator WARNING: Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter 1, Safety Information. WARNING: If the ventilator has been transported or stored at a temperature that differs more than 20°C (36°F) from the temperature in which it will be operating, the ventilator should be allowed to stabilize in its operating environment for at least 2 hours prior to use.

• Page 110: Figure 5-1. Turning On The Ventilator

  If the ventilator fails the alarm tests or if you cannot complete the tests, refer to section 3.9, Troubleshooting or call your equipment supplier or Covidien. WARNING: Due to the internal battery’s limited reserve capacity, the ventilator should only be operated on the internal battery when no other power source is available.

• Page 111: Figure 5-2. Ventilation On/Off Button And Standby Indicator

  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 •…

• Page 112: Usb Menu Parameters

  Only one USB memory device may be connected at any time; otherwise, an error message will be shown. To access patient data via a PC, the Puritan Bennett™ Respiratory Insight software package is avail- able for clinicians. Contact Covidien or your product representative for further information. User Manual…

• Page 113: Usb Memory Device Specifications

  USB Menu Parameters USB Memory Device Specifications 5.2.1 Table 5-1.  USB Memory Device Specifications Characteristics Supported formats USB compatibility USB flash memory USB 2.0 or USB 1.1, 32 bit format Number of files Maximum 999 (sector size: 512-2048 bytes) USB size 128 MB to 4GB (to guarantee accuracy of transfer time, at least 10% of the USB memory device capacity must be free) USB Memory Device Menu 5.2.2…

• Page 114: Figure 5-6. Selecting Transfer Continuously

  Operating Procedures 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 package.

• Page 115: Figure 5-7. Selecting Transfer Trends

  USB Menu Parameters Note: Other functions of the USB memory device are not available during continuous recording. 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.

• Page 116
  Operating Procedures Press ENTER to confirm the new parameter setting. The new parameter setting is shown continuously. • The cursor is placed at the STOP position. • To manually stop trend transfer, press ENTER. If a parameter change is not confirmed by pressing ENTER before 7 seconds elapse, the ventilator resets the parameter to its previous value.

• Page 117: Starting Ventilation

  Starting Ventilation Starting Ventilation Before starting ventilation, see Appendix C, Operational Verification Checklist, and set the parameter values in the Preferences menu. WARNING: Verify the functionality of the alarms before connecting the patient to the ventilator. WARNING: Before starting ventilation, ensure that the device is properly assembled and that the air inlet, cooling vents, and alarm sound diffusion holes are not obstructed.

• Page 118: Stopping Ventilation

  Operating Procedures Figure 5-9.  Starting Ventilation 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.

• Page 119: Turning Off The Ventilator

  Turning Off the Ventilator Figure 5-11.  Stopping Ventilation (2) A double beep sounds. • Release the VENTILATION ON/OFF button. Press the VENTILATION ON/OFF button again 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 button (Figure 5-9, item 2) illumi- •…

• Page 120
  Operating Procedures 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.

• Page 121: Internal Battery

  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™…

• Page 122: Battery Capacity

  Internal Battery 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 character- istics of the patient. With a fully charged battery at a normal room temperature of 25°C (±5°C), the ventilator can be expected to operate on internal battery power for the average durations shown in Table 6-1.  …

• Page 123: Battery Operation

  Battery Operation 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.

• Page 124: Figure 6-2. Battery Reserve Capacity As A Percentage

  Internal Battery If ventilation is stopped, the internal battery reserve capacity is shown as a percentage of battery charge. See Figure 6-2.   Figure 6-2.  Battery Reserve Capacity as a Percentage 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, 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).

• Page 125: Testing The Battery

  Testing the Battery 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.

• Page 126: Storage

  Internal Battery WARNING: Even if the internal battery indicator is off, charge of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 40°C (104°F). This is due to the characteristics of the battery’s internal heat safety device. Although it is not necessary to start the ventilator to charge the battery, charging the battery during operation will increase the time required to fully charge the internal battery.

• Page 127: Cleaning

  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.

• Page 128: Cleaning The Accessories

  Cleaning To clean the surface of the ventilator: Dip a clean, soft cloth into a mixture of mild soap and water, or other approved cleaning solution. For a list of approved cleaning solutions, see Table 7-1.   Table 7-1.  Approved Cleaning Solutions for Exterior Ventilator Surfaces Description Mild dishwashing detergent 70% isopropyl alcohol (rubbing alcohol)

• Page 129: Cleaning The Exhalation Block

  Cleaning the Exhalation Block 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.

• Page 130: Pneumatic System

  Cleaning Pneumatic System This section describes the components of the pneumatic system. Figure shows a pneumatic block diagram of the Puritan Bennett™ 560 Ventilator, including the patient circuit. The main pneumatic components that can potentially get contaminated during use are the air inlet filter (2); low pressure oxygen inlet /valve (36); oxygen solenoid valve (37); inlet and outlet silencers (not shown);…

• Page 131
  Pneumatic System Humidifier, nebulizer, or additional water traps (not shown) Power supply (located above power management PCBA) Inspiratory tubing Power switch Proximal pressure tube AC input Patient wye DC input Inspiratory pressure sensor PC port Proximal pressure sensor Type A USB ports (2) Exhalation valve pilot tube port (not used) Buzzer PCBA…
• Page 132
  Cleaning Page Left Intentionally Blank User Manual…

• Page 133: Routine Maintenance

  Do not attempt to open, repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, and/or void your warranty. Only personnel authorized and qualified by Covidien should repair, open or service the ventilator. WARNING: Ensure that the ventilator is powered off and not in use before performing routine maintenance.

• Page 134: Calibrating The Exhalation Flow Sensor

  Routine Maintenance Calibrating the Exhalation Flow Sensor Each time the exhalation block or circuit is removed and reinstalled or after installing a new exhala- tion block, the exhalation flow sensor must be recalibrated before using the ventilator. This process is automatic and does not require the use of a measurement device. Note: Perform calibration with either an adult or pediatric circuit.

• Page 135
  Calibrating the Exhalation Flow Sensor Figure 8-2.  Calibrating the Exhalation Flow Sensor (1) Press the UP or DOWN key. “YES” is shown instead of “OFF”. Figure 8-3.  Calibrating the Exhalation Flow Sensor (2) Press the ENTER key to start calibration. The message “…Exp. calib. Processing…” is shown in the window on the right while calibration is in •…

• Page 136: Calibrating The Fio2 Sensor

  Routine Maintenance A short beep sounds to confirm the second adjustment. • This process continues until adjustments are complete for all eight calibration points. • Note: The exhalation flow sensor calibration procedure, once initiated, must run to its conclusion. Note: No message is shown when the ventilator passes calibration;…

• Page 137
  Calibrating the FiO2 Sensor Press the ENTER key twice to access the Patient column (central column) of the FiO setup line. “OFF” flashes in the central column. • “OFF” flashes in the window on the right. • The message “FiO Calibration?”…

• Page 138: Replacing The Air Inlet Filter

  Routine Maintenance Figure 8-7.  Calibrating the FiO Sensor (3) A short beep sounds to confirm that the FiO sensor has been calibrated. • Press the ENTER key to exit the FiO setup line. Note: The FiO sensor calibration procedure, once initiated, must run to its conclusion. In the event of calibration errors, the following events occur: An alarm is activated and the message “FiO CALIBRATION FAIL”…

• Page 139: Figure 8-8. Replacing The Air Inlet Filter

  Replacing the Air Inlet Filter Figure 8-8.  Replacing the Air Inlet Filter To replace the air inlet filter (see Figure 8-8): Hold the filter between your fingers (view 1). Remove the filter (view 2) and discard it as instructed by the responsible organization. WARNING: Contact local authorities to determine the proper method to dispose of potentially hazardous parts and accessories.

• Page 140: Recommended Schedule Of Maintenance

  Routine Maintenance Recommended Schedule of Maintenance Preventive Maintenance Intervals 8.6.1 Table lists the periodic maintenance activities required for the Puritan Bennett™ 560 Ventilator. Total machine hours appear on the welcome screen that appears when turning on the ventilator with the power switch, in the Preferences menu during normal operation, and also when entering maintenance mode.

• Page 141
  For all additional accessories not necessarily considered as consumables consult the manufacturer’s recommendations. Note: To prevent any risk of cross contamination, Covidien recommends the use of DAR™ filters (Ref: 351/5856 or equivalent) to protect the patient outlet port and the exhalation block port. User Manual…

• Page 142: Maintenance Of The Internal Battery

  Routine Maintenance Failure to observe these recommendations may result in a loss of performance, excessive overheat- ing, a loss of certain functions and, in the long term, compromise the longevity of the ventilator. Maintenance of the Internal Battery 8.6.2 The internal battery does not need to be removed to verify its correct operation. Periodic Test of the Internal Battery 8.6.3 The ventilator continuously and automatically checks the state of the internal battery, even when…

• Page 143: Service Assistance

  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 Service Centers in the Preface.

• Page 144
  Routine Maintenance Page Left Intentionally Blank 8-12 User Manual…

• Page 145: Specifications

  A Specifications Physical Table A-1.  Physical Description (excluding accessories) Ventilator weight 9.9 lb. (4.5 kg) Ventilator dimensions 9.25 in wide x 12.40 in deep x 6.0 in high (235 mm wide x 315 mm deep x 154 mm high) Connectors Inspiratory limb connector: ISO 22 mm (OD) conical Exhalation limb connector (on exhalation block): ISO 22 mm (ID) conical Oxygen inlet: female connector with valve Device airway volume…

• Page 146: Indicators And Alarms

  Specifications Table A-3.  Internal Lithium Ion Battery Voltage 25.2 VDC Full-load capacity 4.8 Ah On standby: 1.5 Ah Ampere-hour rating During ventilation: 0.5 Ah Watt hour rating 124 Wh to 126 Wh Standby mode: 1.5 A/hr. (duration: <6 hr.) Charging current Ventilation mode: 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…

• Page 147: Performance

  Performance Performance Note: Performance specifications listed are applicable when dry gases are used in the patient system. Table A-7.  Performance Parameter Specifications and Tolerances Settings Range Tolerances Volume 50 to 2000 ml ±(10 ml +15%) Pressure 5 to 55 mbar ±(1 mbar +10%) Time 0.3 to 6.0 s ±10%…

• Page 148: Range, Resolution, And Accuracy

  Specifications Table A-8.  Monitored Parameter Tolerances (Continued) Ventilator parameter Tolerances Inspiratory Minute Volume (M VoI) ±(10 mL +15% VTI) ×Rate (with exhalation valve) and ±(20 mL +20% VTI) ×Rate in NIV configuration (without exhalation valve) Vt Sigh ±(20ml +20%) ±(2.5% +2.5% FiO Leak ±(3 lpm +20%) Apnea Index (AI)

• Page 149
  Range, Resolution, and Accuracy Table A-9.  Ventilator Range, Resolution, and Accuracy (Continued) Ventilator settings Range, resolution, and accuracy Pressure support Range: OFF or 5 mbar to 55 mbar in valve configuration (P Support) Range: 6 mbar to 30 mbar in leak configuration Resolution: 1 mbar Accuracy: ±(1 mbar +10%) of P Support + PEEP setting Default value: 15 mbar…
• Page 150
  Specifications Table A-9.  Ventilator Range, Resolution, and Accuracy (Continued) Ventilator settings Range, resolution, and accuracy Ramp Range: Square (SQ), descending ramp (D), sinusoidal (S) (Flow Pattern) Resolution: N/A Default value: Descending ramp (D) In V SIMV, flow pattern is set to square and is not adjustable PEEP Range: OFF (0.5 mbar) to 20 mbar Resolution: 1 mbar…
• Page 151
  Range, Resolution, and Accuracy Table A-9.  Ventilator Range, Resolution, and Accuracy (Continued) Ventilator settings Range, resolution, and accuracy Maximum Exhaled Tidal Volume Range: 80 mL to 3000 mL (Max VTE) Resolution: 10 mL Default value: 1000 Depends on: Min VTE Maximum Respiratory Rate Range: 10 bpm to 70 bpm in CPAP, P A/C, and V A/C modes and 17 bpm to 70 bpm in P SIMV and V SIMV modes (Max Rtot)

• Page 152: Environmental

  Specifications Environmental The following environmental conditions shall be observed: Table A-10.  Environmental Conditions for Storage or Transport Temperature Humidity Atmospheric pressure Altitude -40°C to +70°C 10% to 95% RH 500 hPa to 1060 hPa -152 m to 3964 m (-40°F to +158°F) (7.2 psi to 15.4 psi) (500 ft to 13 000 ft) Table A-11.  Environmental Conditions for Operation…

• Page 153: Pneumatic

  Pneumatic Pneumatic Table A-14.  Airway Resistances Inspiratory Exhalation 1.0 mbar at 30 lpm flow ±0.1 mbar 0.5 mbar at 30 lpm ±0.1 mbar 3.7 mbar at 60 lpm flow ±0.1 mbar 1.1 mbar at 60 lpm ±0.1 mbar Table A-15.  Patient Circuit Resistances Adult double limb Pediatric double limb 2 mbar at 30 lpm flow 2 mbar at 60 lpm flow…

• Page 154: Manufacturer’s Declaration

  Specifications Manufacturer’s Declaration A.10 Tables A-19 through A-22 contain the manufacturer’s declarations for the ventilator’s electromagnetic emissions and electromagnetic immunity, as well as a list of compliant cables. WARNING: Portable and mobile RF communications equipment can affect the performance of the Puritan Bennett™…

• Page 155
  Manufacturer’s Declaration Table A-19.  Electromagnetic Emissions 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. Phenomenon and standard Compliance Electromagnetic environment – guidance Conducted and radiated RF emissions Group 1 The ventilator uses RF energy only for its internal functions.
• Page 156
  Specifications Table A-21.  Electromagnetic Immunity—Conducted and Radiated RF Phenomenon Basic EMC standard or test Immunity test levels for Home Healthcare method environment Conducted disturbances induced by RF IEC/EN 61000-4-6 fields 0,15 MHz–80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz Radiated RF EM fields…

• Page 157: Standards Compliance And Iec Classification

  Standards Compliance and IEC Classification Table A-22.  Compliant Cables and Accessories (Continued) Cable or accessory Maximum length 12V DC car adapter cable 5 m (16.4 ft) Oxygen inlet connector Puritan Bennett™ power pack (4098100) Standards Compliance and IEC Classification A.11 General Standards A.11.1 Medical Electrical Equipment: General Requirements for Safety IEC 60601-1 •…

• Page 158: Particular Standards

  Specifications Particular Standards A.11.3 Particular requirement for basic safety and Essential performance of home healthcare environmental • ventilators for ventilator-dependent patients — EN ISO 80601-2-72. Anesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets EN ISO 5356-1. •…

• Page 159: Modes Of Ventilation

  B Modes of Ventilation Overview This chapter is a general description of the various modes of ventilation and breath types available with the Puritan Bennett™ 560 ventilator. Note: The default ventilation mode setting is P A/C; for more information, see below. 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.

• Page 160: Cpap Mode

  Modes of Ventilation CPAP Mode In CPAP, the ventilator maintains a constant level of pressure in the patient’s airway. PSV Mode PSV mode maintains a constant level of pressure in the patient’s airway during exhalation. In addi- tion, the ventilator applies a clinician-set pressure (Pressure Support) to each of the patient’s breaths.

• Page 161
  • If the ventilator fails any of the safety checks below, or if you cannot complete these checks, see section 3.9, Troubleshooting or call the equipment supplier or Covidien (see section 8.7, Service Assistance). WARNING: Provide the patient with an alternate means of ventilation before conducting these tests.

• Page 162: Operational Verification Checklist

  Operational Verification Checklist Table C-1.  Operational Verification Checklist Verify that the preventive maintenance schedule for the ventilator is followed. See Chapter 8, Routine Mainte- Pass nance. Ensure the patient breathing circuit is correctly attached to the ventilator, with all the necessary components, Pass and is free from any signs of damage and leaks.

• Page 163
  D Unpacking and Preparation The Puritan Bennett™ 560 ventilator is delivered with the items listed in Table D-1. Table D-1.  Items Included with Ventilator Item Quantity Printed user’s manual Clinician’s manual on CD Patient circuit and valve Set of six combination foam/fine particle air inlet filters Dual bag (carrying bag) Oxygen connector AC power cable…

• Page 164: Unpacking And Preparation

  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. Clean the ventilator with a mild soap solution, if necessary (see Chapter 7, Cleaning).

• Page 165
  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 8.7, Service Assistance). WARNING: The Min PIP alarm setting must be adjusted for the patient, but must also be set high enough to allow the Patient Disconnection alarm to trigger properly.

• Page 166: Alarms Tests

  Alarms Tests Low Pressure Test WARNING: The Min PIP alarm setting 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 that the Low PIP alarm is properly set.

• Page 167: Max Leak Test (Only Niv

  Max Leak Test (Only NIV) Max Leak Test (Only NIV) WARNING: The Max Leak alarm setting must be adjusted for the patient, but must also be set low enough to allow the High Leakage alarm to trigger properly. Perform the following test to ensure that the alarm is functioning properly.

• Page 168: Circuit Check

  Alarms Tests Press and hold the VENTILATION ON/OFF key for 3 seconds, then release it. Press the VENTILATION ON/OFF key again to confirm stop. Ventilation stops • 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.

• Page 169: Performing The Circuit Check

  Circuit Check Performing the Circuit Check E.3.2 To perform a circuit check: Verify that the proximal pressure tube of the patient circuit is properly connected to the proximal pres- sure port (see section 4.4, Patient Circuit). Verify that the exhalation valve tube is connected to the exhalation valve port. Block the patient connection port or patient wye of the patient circuit (see Figure E-4).

• Page 170: Figure E-6.   Circuit Check (Complete, Passed)

  Alarms Tests Increase pressure to 30 mbar (±10% with no leak) Show 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 (see Figure E-6) or FAIL (see Figure E-7) in the Test Status field Figure E-6.  Circuit Check (complete, passed) Figure E-7.  Circuit Check (complete, failed)

• Page 171: Troubleshooting A Failed Check

  Power Failure Test Troubleshooting a Failed Check E.3.3 If the circuit check fails, do the following: Ensure an approved circuit is in use. See Table F-2.   Check patient circuit connections to the ventilator, examining each for leakage and tightness. Replace the patient circuit if necessary. Rerun the circuit check.

• Page 172: Occlusion Test

  Alarms Tests The AC Power Disconnection alarm is shown • Figure E-8.  Ventilator Screen (AC Power Disconnection alarm shown) Press the ALARM CONTROL key twice to reset the alarm. Reconnect the ventilator to its AC power supply. Occlusion Test To perform an occlusion test: 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, Patient…

• Page 173: Battery Test

  Battery Test After two breaths or after 5 seconds, whichever takes longer, ensure that the following events occur: The high priority indicator (flashing red LED) illuminates • An audible alarm sounds • The Occlusion alarm is shown; the Low VTI alarm may also activate •…

• Page 174: Involuntary Stop Test

  Alarms Tests Figure E-11.  Ventilator Screen (AC Power Disconnection alarm shown) Press the ALARM CONTROL key twice to reset the alarm. Ensure that the following events occur: The internal battery indicator to the upper-left of the display illuminates • The battery symbol is shown at the top of the screen (along with its reserve capacity) •…

• Page 175: Table F-1.   List Of Consumables And Accessories

  Table provides a list of accessories that are available for the Puritan Bennett™ 560 ventilator. To order parts or accessories, contact your equipment supplier or Covidien representative. For a list of items delivered with the ventilator, see Appendix D, Unpacking and Preparation.

• Page 176: Parts And Accessories

  Adult-pediatric HME (formerly Hygrolife II) Table provides a list of consumable parts available for the ventilator. WARNING: To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this manual; see Chapter 4, Installation and Assembly and Appendix F, Parts and Accessories.

• Page 177
  G Glossary AC Power Alternating current. Alarm Pause The audible and visual alarms cease and the alarm paused 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.

• Page 178: Glossary

  Glossary Back Up Rate Rate of control cycles in PSV or SIMV modes during apnea phase. Battery Level Display of the remaining battery capacity; located adjacent to the battery symbol. Bias Flow Turbine flow during exhalation phase through the patient circuit to avoid rebreathing. An abbreviation for “breaths per minute,”…

• Page 179
  Exhalation Tidal Volume (VTE) Volume exhaled by the patient at each exhalation phase. Exhaled Tidal Volume (VTE) Exhaled volume measured for all breath types through the exhalation block. Monitored value avail- able only with double-limb patient circuit. Exhaled volume is computed using a five-breath average. Fraction of Inspired Oxygen (FiO Amount of oxygen delivered to the patient.
• Page 180
  Glossary 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. 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.
• Page 181
  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 × Rtot). Non-Invasive Ventilation (NIV) Patient ventilation without the use of an endotracheal tube;…
• Page 182
  Glossary Pressure Support (P Support) Augmentation of the patient’s ventilation synchronously with inspiratory effort until a preset pres- sure 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.
• Page 183
  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.
• Page 184
  Glossary Page Left Intentionally Blank User Manual…
• Page 185
  Index INTENTIONAL VENT STOP ……3-13, 3-22 KEYPAD FAULT ……..3-13, 3-22 AC power LOW BATTERY .
• Page 186
  Index Reserve capacity display Check Settings alarm Ventilation running ……..6-4 Cause &…
• Page 187
  Index High Internal Temperature alarm Device Fault 7 alarm Cause & response ………3-12 Cause &…
• Page 188
  Index Maintenance ……….8-10 Periodic test .
• Page 189
  Index Power Supply Loss alarm Single-limb patient circuit Cause & response ……… 3-14 Installing Corrective action .
• Page 190
  Index USB menu VTI Not Reached alarm Transfer continuously ……..5-5 Cause &…
• Page 192
  Part No. PT00106571 Rev A 2019-07 © 2019 Covidien. All rights reserved. Covidien llc 15 Hampshire Street, Mansfield, MA 02048 USA Covidien Ireland Limited, IDA Business and Technology Park, Tullamore, Ireland. www.Medtronic.com [T] 1 800 635 5267…

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1. Manuals
2. Brands
3. Medtronic Manuals
4. Fan
5. PURITAN BENNETT 980
6. Installation reference manual

• Page 1
  INSTALLATION & REFERENCE GUIDE – ADAPTER HAS NOT BEEN CLEARED BY US FDA |For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 2: Table Of Contents

  CLEANING THE PB980 EXHALATION FILTER ADAPTER …………….12 APPENDIX A. PERFORMING FLOW SENSOR CALIBRATION, AND SST …………. 14 | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 3: Preface

  THE PB980 EXHALATION FILTER ADAPTER’ on Page 10 of this guide. | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 4
  This feature may only be used in the event of a PB980 Pediatric-Adult Exhalation Filter not being available due to the unforeseen demand caused by COVID-19 pandemic. | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…
• Page 5
  INSTALLING THE PB980 EXHALATION FILTER ADAPTER PLATE AND ADAPTER | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 6: Preparing The Pb980 Exhalation Filter Adapter Plate And Adapter For Installation

  Dry Adapter Plate and Adapter per current site Sterilization Procedures. | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 7: Installing The Pb980 Exhalation Filter Adapter Plate And Adapter For Use

  PB980 Adapter Plate and Adapter are uninstalled. | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 8
  PB980 Exhalation Adapter Plate. Recommended hand-tightening with 5/64 Hex Driver. | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…
• Page 9
  SST on the PB980 Ventilator, following instructions provided in Appendix A (page 13). | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…
• Page 10
  USING PB980 VENTILATOR WITH THE PB980 EXHALATION FILTER ADAPTER | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 11: Filter Installation With Pb980 Exhalation Filter Adapter

  Note: More frequent inspections of the filters are needed to check for condensate and increased filter resistance. | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 12: Cleaning The Pb980 Exhalation Filter Adapter

  Local support can be obtained by Medtronic staff through your normal communication channels. © 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Agile P/N : RE00262677 | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been…

• Page 13
  APPENDIX A. PERFORMING FLOW SENSOR CALIBRATION, AND SST ON THE PB980 | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 14: Appendix A. Performing Flow Sensor Calibration, And Sst

  1. Put the PB980 into Service Mode by following the guidance in the Puritan Bennett 980 Series Ventilator Operator’s Manual below: | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…

• Page 15
  | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…
• Page 16
  2. Next, perform Flow Sensor Calibration as defined below: | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…
• Page 17
  SHORT SELF-TEST (SST) 3. Perform SST as defined below: | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…
• Page 18
  NOTE: All screenshots taken for Appendix A were from either (P/N: PT00102829A00) or (P/N: PT00101843A00) | For COVID-19 Response for Medtronic Customer & Hospital Only. PB980 Exhalation Filter Adapter Plate and Adapter have not been cleared by US FDA | RE00262677 | Rev. B…