Covidien Puritan Bennett 560 User Manual Download Page 124 | Manualshive

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Specifications

A-14

User’s Manual

Particular Standards

•

Lung Ventilators for Medical Use- Particular Requirements for Basic Safety and Essential
Performance Part 2: Home Care Ventilators for Ventilator-Dependent Patient EN ISO10651-
2:2009.

•

Lung ventilators for medical use – Particular requirements for basic safety and essential
performance – Part 2: Home care ventilators for ventilator – dependent patients YY 0600.2-
2007 (ISO 10651-2:2004, MOD).

•

Medical electrical equipment – Part 2: Particular requirements for the safety of lung
ventilators – Critical care ventilators GB 9706.28-2006 (IEC / EN 60601-2-12:2006, MOD)

•

Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets EN
ISO 5356-1:2004.

Air Transportation Standards

•

Environmental Conditions and Test Procedures for Airborne Equipment - RTCA/DO-
160:2007.

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Summary of Contents for Puritan Bennett 560

Page 1: ...User s Manual Puritan Bennett 560 Ventilator TM...

Page 2: ...itute for the exercise of professional judgment The ventilator should be operated and serviced only by trained professionals Covidien s sole responsibility with respect to the ventilator and its use i...

Page 3: ...11 USB Memory Device Menu 2 10 2 12 If Ventilator Failure Occurs 2 10 3 Alarms and Troubleshooting 3 1 3 1 Alarm Level of Priority 3 2 3 2 Alarm Display 3 3 3 3 Alarm Logs Menu 3 4 3 4 Silencing the A...

Page 4: ...g Ventilation 5 8 5 5 Turning Off the Ventilator 5 9 6 Internal Battery 6 1 6 1 Battery Capacity 6 1 6 2 Battery Operation 6 2 6 3 Testing the Battery 6 4 6 4 Recharging the Battery 6 4 6 5 Storage 6...

Page 5: ...odes B 1 B 1 3 CPAP Mode B 1 B 1 4 PSV Mode B 2 C Operational Verification Checklist C 1 D Unpacking and Preparation D 1 E Alarms Tests E 1 E 1 Low Pressure Test E 1 E 2 Power Failure Test E 2 E 3 Occ...

Page 6: ...This page intentionally blank iv User s Manual...

Page 7: ...ng the Ventilator to an External DC Power Source 4 5 Figure 4 6 Connecting the DC Power Cable to the Ventilator 4 6 Figure 4 7 Single Limb Patient Circuit With Exhalation Valve 4 8 Figure 4 8 Double L...

Page 8: ...rve Capacity as a Percentage 6 3 Figure 6 3 Battery Reserve Capacity in Hours and Minutes 6 3 Figure 6 4 Power Indicators When Charging the Battery 6 5 Figure 8 1 Replacing the Air Inlet filter 8 2 Fi...

Page 9: ...mance Parameter Specifications and Tolerances A 3 Table A 9 Monitored Parameter Tolerances A 3 Table A 10 Ventilator Range Resolution and Accuracy A 4 Table A 11 Environmental Conditions for Storage o...

Page 10: ...viii User s Manual This page is intentionally blank...

Page 11: ...ischarges 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...

Page 12: ...idien Costa Rica La Uruca 75 Metros al Oseste de Faco Oficentro La Virgen Edificio I San Jose Costa Rica Tel 506 256 1170 Fax 506 256 1185 Fax 506 290 8173 Covidien Czech Republic Vyskocilova 1410 1 1...

Page 13: ...21 S Domingos de Rana Portugal Tel 35 121 448 10 36 Fax 35 121 445 1082 Covidien Puerto Rico Palmas Industrial Park Road 869 Km 2 0 Bdlg 1 Cata o PR 00962 Tel 787 993 7250 Ext 7222 7221 Fax 787 993 72...

Page 14: ...4 User s Manual This page is intentionally blank...

Page 15: ...ing key is enabled For additional assistance contact your Clinician or equipment representative General Warnings Regarding Use of Equipment The ventilator must be used only under the responsibility an...

Page 16: ...ilation is in progress When the power switch is turned back on again ventilation will resume without having to press the VENTILATION ON OFF button To reduce the risk of infection wash your hands thoro...

Page 17: ...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...

Page 18: ...he internal battery when no other power source is available Ensure that the internal battery never becomes fully discharged When using a car auxiliary adapter cigarette lighter ensure the car has been...

Page 19: ...that the patient circuit type fits and in all respects is suitable for use with a child Use a pediatric circuit for patients that weigh under 53 lb 23 kg To ensure proper performance of the ventilator...

Page 20: ...sure that the Nurse Call device is always connected to the ventilator Warnings Regarding Settings Before starting ventilation always verify that all settings are properly set in accordance with the re...

Page 21: ...odified in order to avoid the risk of false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setti...

Page 22: ...ircuit 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 i...

Page 23: ...n with a calibrated oxygen analyser FIO2 kit that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient The Puritan...

Page 24: ...ons for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix A Specifications In particular the use of nearby mobile and portable commun...

Page 25: ...ventilator s enclosure defined in IEC 60529 BSEN60529 1991 The first digit 3 indicates protection against the intrusion of small foreign bodies including fingers tools wires etc with a diameter great...

Page 26: ...nection of the tubing between the patient circuit exhalation valve see Figure 1 1 on page 1 16 and Figure 1 4 on page 1 18 item 3 Oxygen inlet This marking appears on the back panel of the ventilator...

Page 27: ...tatus window when the patient triggers a breath Parameter adjustment bar This graphic shows the current setting for parameters such as display contrast and alarm volume in the Preferences menu WEEE Wa...

Page 28: ...re to the instructions contained in the product s user manuals USB port This symbol indicates a communications port for interfacing with a USB connector See Figure 2 2 item 11 PC connector This symbol...

Page 29: ...2 Ventilator Labels and Markings 1 Patient Gas Inlet Label Figure 1 1 Figure 1 4 2 Oxygen Inlet Marking and Label Figure 1 3 3 Exhalation Valve and Patient Pressure Connection Label Figure 1 1 Figure...

Page 30: ...al Figure 1 1 Locations of Labels Top Front View 13 FIO2 Label Figure 1 1 Figure 1 4 Table 1 2 Ventilator Labels and Markings Continued Note The item number callouts in the following figures refer to...

Page 31: ...Safety Information User s Manual 1 17 Figure 1 2 Locations of Labels Front Left View Figure 1 3 Location of Labels and Markings Rear View 6 4 2 12 2 8 5 11 10 9...

Page 32: ...Safety Information 1 18 User s Manual Figure 1 4 Location of Labels Bottom View 7 13 1 4 3...

Page 33: ...heir airline to demonstrate evidence of compliance with the RTCA DO 160F standard as well as other requirements Contact your airline prior to travel to determine airline specific requirements and docu...

Page 34: ...stem that continuously monitors both patient and machine for signs of specific errors or faults that could lead to an unsafe condition Should any of these errors or faults be detected the alarm system...

Page 35: ...EC EN 60601 1classification is as follows Protection Insulation class electric shock Class II Protection index of enclosure IP31 Medical device directive classification II B Degree of protection again...

Page 36: ...and off the ventilation configuring ventilation modes silencing and cancelling alarms and setting device and alarm parameters 7 Lateral and Front Openings Vents that allow for air circulation to cool...

Page 37: ...essure oxygen source via an adaptor connected to the O2 Inlet refer to section 4 8 Oxygen 3 AC power Mains cable connector 9 Nurse Call Output Connector Used to connect the ventilator to the nurse cal...

Page 38: ...evice screen 3 Display screen Display of modes ventilation settings patient data and waveforms configuration of the ventilator and alarm management 8 VENTILATION ON OFF button ON Press briefly and rel...

Page 39: ...n mode 3 Preferences menu access line Highlight this line and press the ENTER key to display the Preferences menu 4 Bargraph Displays pressure generation during ventilation 5 Status monitored data win...

Page 40: ...n and Max alarm threshold settings and Current monitored patient readings or hyphen when ventilation is in standby 3 Access line to Alarm Logs menu Highlight this line and press the ENTER key to displ...

Page 41: ...g symbols Battery if the ventilator is powered by the internal battery Audio paused if an alarm is currently inhibited Alarm paused if an alarm has been cancelled manually and the cause of the alarm r...

Page 42: ...tient from the ventilator and provide an alternate means of ventilation Keep in mind that troubleshooting information is available in this manual to assist you in the event of a prob lem Refer to chap...

Page 43: ...non adjustable alarms also exist to create a safety net for safer patient ventilation Alarms indicate events likely to affect the ventilation in the short term and necessitate rapid intervention refe...

Page 44: ...ing High Priority HP Critical situation in the short term ventilation is potentially compromised High Speed Intermittent Sound Signaling Flashing Red LED Illumination With Message With Display Lightin...

Page 45: ...u or Alarm Menu Note There are currently no Low Priority LP Alarms When an alarm is triggered if the current menu displayed is not the Ventilation parameters or Alarm menu the display automatically sw...

Page 46: ...g menu if this is not the menu currently displayed 2 Press the DOWN key several times or press until the cursor is on the Alarm Logs line at the bottom of the page The display appears as follows Figur...

Page 47: ...ons light indicator and message of activated alarms remain visible The Audio Paused symbol is displayed at the top right of the screen while the audio pause function is active Figure 3 4 Silencing the...

Page 48: ...nually even if the cause s of their activation remain s To manually pause an alarm proceed as follows Press the ALARM CONTROL key twice The alarm is paused until the alarm condition is corrected and t...

Page 49: ...dy the case Refer to the following graphic Figure 3 6 Reactivating Alarms 3 Press the ENTER key to confirm access to the Alarm Logs menu 4 Press the UP key to position the cursor on the USER S CLEAR A...

Page 50: ...otherwise to the internal battery MP Yes Yes APNEA No inspiratory trigger detected by the ventilator after the apnea time set in PSV CPAP P SIMV and V SIMV modes Automatically clears itself after two...

Page 51: ...halation valve obstructed HP Yes No CHECK EXH VALVE PRESSURE Internal ventilation fault related to exhalation valve detection sensor pressure sensor HP Yes Yes CHECK FIO2 SENSOR FIO2 measurement is le...

Page 52: ...in the 24 V power supply HP Yes No DEVICE FAULT5 RESTART SRVC Detection of a fault in the electrical power supply system Consequence the internal battery capacity is not displayed beside the battery...

Page 53: ...erature out of tolerance range MP Yes Yes HIGH LEAKAGE The LEAK estimated by the ventilator exceeds the Max LEAK alarm threshold MP Yes No HIGH PRESSURE In V A C or V SIMV modes if Inspiratory Pressur...

Page 54: ...e caregiver or patient HP Yes Yes KEYPAD FAULT RESTART SRVC IF PERSISTS RESTART SRVC Keyboard key held down for more than 45 seconds HP No No LOW BATTERY Internal battery capacity 30 min or 8 HP Yes N...

Page 55: ...and Apnea time 2 sec in CPAP and PSV mode disconnection time and 60 R Rate Insp time in P SIMV and V SIMV mode HP Yes No If the flow is greater than 130 lpm during the inspiratory phase In V A C and...

Page 56: ...s No SOFTWAREVERSION ERROR Detection of a wrong software version NA NA NA TURB OVERHEAT RESTART SRVC Turbine speed too low and temperature too high Consequence ventilation stops immediately and O2 sup...

Page 57: ...and parameters can be changed Many of the functions of the ventilator are not accessible when the Locking key is enabled For additional assistance contact your Clinician or equipment representative Ta...

Page 58: ...he ventilator I O Leave to charge for at least 15 minutes If persists restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative BUZZER LOW B...

Page 59: ...Check for moisture or occlusion of the proximal line Reduce humidifier temperature Switch to a heated wire circuit Defective proximal pressure sensor or internal leak of the machine Restart ventilato...

Page 60: ...isconnected reconnect patient to reset the fault If persists restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative DEVICE FAULT10 IF PER...

Page 61: ...the inspiratory phase Replace the exhalation valve and or its control tube Contaminated or defective exhalation flow sensor Restart ventilator to see if alarm clears If not have a qualified technicia...

Page 62: ...esentative HIGH LOW BATTERY TEMP IF PERSISTS RESTART SRVC Battery temperature out of the tolerance ranges Defective internal temperature probe or any other technical anomaly inside the battery Note En...

Page 63: ...just Max Rtot Adjustment of the I Sens level too low Adjust I Sens according to the patient Patient hyperventilating Silence the alarm and call for a medical team if the symptoms persist Check for aut...

Page 64: ...The user caregiver has stopped ventilation using the VENTILATION ON OFF key Ventilation is in stand by Check that the ventilation was switched off on purpose KEYPAD FAULT RESTART SRVC Pressing a key f...

Page 65: ...ify the Min VTI level Adjustment of the pressure level not enough to reach the volume required for PSV CPAP P A C P SIMV and V SIMV modes Modify the pressure level according to the physician s prescri...

Page 66: ...ES SENS FLT1 RESTART SRVC Defective internal pressure sensor Restart ventilator to see if alarm clears If not have a qualified technician replace the defective component s and call your customer servi...

Page 67: ...nit is first powered on after the internal battery has been completely drained Connect to an AC power source and recycle power Many of the functions of the ventilator are not accessible when the Locki...

Page 68: ...damaged Replace the ventilator and call your customer service representative Excessive heat emitted Obstruction of main or secondary air inlets of the casings Remove obstructions from all blocked ven...

Page 69: ...e operator should connect the ventilator to an AC power source whenever available for safer operation To ensure correct and lasting operation of the ventilator ensure that its air circulation holes ma...

Page 70: ...ons equipment using radio frequencies such as mobile telephones or other systems exceeding the levels set in the IEC EN 60601 1 2 standard may affect its operation Refer to section A 10 Manufacturer s...

Page 71: ...lder Figure 4 2 item 1 into the notch of the battery cover Figure 4 2 Inserting the Power Cable Holder Into the Notch 2 Push the AC power cable into the power cable holder Figure 4 2 item 2 3 Connect...

Page 72: ...C power cable 1 Disconnect the AC power cable from the AC power outlet 2 Disconnect the AC power cable from the ventilator s AC connector at the rear of the device 3 Grasp the AC power cable at the le...

Page 73: ...tilation should always be available particularly when the patient is in transit or away from wall power While using the ventilator on external battery power it is vital that a qualified caregiver capa...

Page 74: ...ts that weigh under 53 lb 23 kg See Table F 2 List of Circuits on page F 2 for a list of recommended patient circuits If exhaled tidal volume measurements are required to ensure correct patient ventil...

Page 75: ...rcuit in the menu preferences in particular ensure that Pediatric Circuit Yes No is set to YES when using a pediatric circuit refer to chapter F Parts and Accessories For information regarding validat...

Page 76: ...acteria filter item 12 7 Connect the exhalation bacterial filter item 12 between the FROM PATIENT inlet port item 10 and the exhalation limb of the patient circuit 8 Connect one end of the small proxi...

Page 77: ...h as cracks which might cause leakage Do not use damaged components to assemble the patient circuit 2 Install the bacteria filter item 1 on the TO PATIENT outlet port as shown 3 Attach one end of the...

Page 78: ...accessory When using non invasive ventilation NIV with an exhalation valve use a non vented mask The level of inspiratory resistance of the circuit and accessories bacteria filter humidifier and so on...

Page 79: ...filter media and located at the rear of the ventilator this filters the air as it enters the ventilator Figure 4 11 Air Inlet Filter Warning The air inlet filter is not reusable do not attempt to wash...

Page 80: ...humidifier to minimise drying of the patient s airways and subsequent irritation and discomfort must be used Always position a humidification device so that it is lower than both the ventilator and t...

Page 81: ...halation flow sensor be recalibrated before the exhalation block is used The exhalation block requires calibration and should only be removed or cleaned by qualified personnel Figure 4 14 Removing the...

Page 82: ...ond to the current oxygen therapy objectives specified by the physician 4 8 2 Connecting the Oxygen Supply Warning Ensure that the only gas supplied to the ventilator through the dedicated oxygen supp...

Page 83: ...nection is locked and secured in place Figure 4 16 Connecting the Oxygen Supply System To disconnect the oxygen supply system from the ventilator Note Ensure the oxygen source is turned off prior to p...

Page 84: ...a humidifier upstream of the ventilator 4 8 3 Connecting the FIO2 sensor When administering oxygen it is recommended to use a FIO2 oxygen sensor that can be connected to the front of the apparatus by...

Page 85: ...protection for the device 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 filt...

Page 86: ...lips 2 Clip the suspension belt onto the central ring 3 Secure the Dual Bag on the wheelchair s push handle 4 Attach the non adjustable side of the maintaining belt to the side clip of the Dual Bag 5...

Page 87: ...User s Manual 4 19 4 11 Mounting the Ventilator on the Utility Cart Match the mounting holes item 1 on the bottom of the Puritan Bennett 560 Ventilator to the mounting studs item 2 on the top of the...

Page 88: ...s 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...

Page 89: ...adapter Be prepared for the possibility of power failure by having an alternative means of ventilation ready for use particularly for ventilator dependent patients Do not start ventilation until you e...

Page 90: ...e PURITAN BENNETT logo is displayed momentarily The blue VENT STDBY indicator to the right of the VENTILATION ON OFF key illuminates indicating the device is in standby mode A Welcome Menu screen is d...

Page 91: ...cally dis played when the USB memory device is connected to the ventilator when ventilation is either on or off Only one USB memory device shall be connected at any time otherwise an error message wil...

Page 92: ...a can be transferred from a ventilator to a USB memory device To record continuously the USB memory device must be permanently connected to the ventilator and ventila tion is active The following data...

Page 93: ...vice provider using the Puritan Bennett Respiratory Insight Soft ware Figure 5 6 Selecting Transfer Trends To transfer trend data from a ventilator to a USB memory device 1 Use the UP or DOWN arrow ke...

Page 94: ...entilator to USB memory device 3 months Approximately 2 minutes 6 months Approximately 4 minutes 9 months Approximately 6 minutes 12 months Approximately 8 minutes Note The message TRANSFER IN PROGRES...

Page 95: ...d nor compressed and contain no obstructions or foreign bodies When the ventilator is in standby the ventilator is on but ventilation has not started a message that prompts the ventilator operator to...

Page 96: ...nt In some circumstances inhaling carbon dioxide may lead to under ventilation suffocation and serious injury or death You can stop your ventilator at any time To stop the ventilator 1 Press and hold...

Page 97: ...will immediately begin ventilating without the user first having to press the VENTILATION ON OFF key Handle the ventilator with care after use particularly when ambient temperatures are high Some ven...

Page 98: ...5 10 User s Manual This page is intentionally blank...

Page 99: ...e the voyage Ensure that the ventilator s internal battery is fully charged before connecting the ventilator to an external DC power source Powering the ventilator using an external 12 30 VDC power so...

Page 100: ...isplayed Values Average Operating Time on Internal Battery Powera Vt 200 ml 5 ml PIP 10 mbar 2 mbar Rtot 20 bpm 11 hours 10 Vt 300ml 5 ml PIP 20 mbar 2 mbar Rtot 15 bpm 9 hours 10 Vt 500 ml 5 ml PIP 3...

Page 101: ...rnal battery reserve is momentarily displayed as a percentage Then after the ventilator calculates the battery time remaining which takes about two minutes depending on the power consumption of the ve...

Page 102: ...TERY FAULT1 alarm is activated whenever a problem is detected in the battery or the charger However on a monthly basis you should disconnect the ventilator from the external power supply to check the...

Page 103: ...ase the time required to fully charge the internal battery When recharging a depleted internal battery it may be necessary to leave the ventilator on charge for up to six 6 hours if the ventilator is...

Page 104: ...f the battery may be affected It will then be necessary to recharge the battery before using it again If the ventilator has been in storage for longer than 30 days connect it to an AC power source tur...

Page 105: ...arning 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...

Page 106: ...easurement quality when used continuously clean the exhalation block periodically The exhalation block should be changed every 4 months and cannot be reused with any other patient Ensure that the exha...

Page 107: ...ularly important when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly Failing to replace a dirty air inlet filter or oper...

Page 108: ...tion Patient Circuit See manufacturer s recommendation Single use Single patient FIO2 Sensor 14 to 18 months or more often in case of persistent calibration failure Exhalation Block 4 months and for e...

Page 109: ...NTHLY by disconnecting the ventilator from exter nal power supplies refer to section 6 Battery Operation Such a test is imperative after opening the venti lator or after a prolonged period of non use...

Page 110: ...rwise service the ventilator yourself Doing so might endanger the patient damage the ventilator and or void your warranty Only qualified service personnel should open repair or service the ventilator...

Page 111: ...ice airway volume 2000 ml Breathing circuit volume Adult dual limb 1150 ml Pediatric dual limb 670 ml Adult single limb 550 ml Pediatric single limb 300 ml Air Inlet Filter Dimensions 70 mm long x 60...

Page 112: ...0 4 5 hr 10 Table A 4 Remote Alarm Remote Alarm Port Also known as the Nurse s Call port it provides for remote alerts of ventilator alarm conditions An example of a setting that requires such a featu...

Page 113: ...me 60 s 1 s 65 to 85 dBA 10 at 1 meter Table A 8 Performance Parameter Specifications and Tolerances Settings Range Tolerances Volume 50 to 2000 ml 10 ml 10 Pressure 5 to 55 mbar 1 mbar 10 Time 0 3 to...

Page 114: ...Ventilator Parameters Tolerances Table A 10 Ventilator Range Resolution and Accuracy Ventilator Settings Range Resolution and Accuracy Mode Range V A C P A C V SIMV P SIMV PSV CPAP Resolution N A Accu...

Page 115: ...SIMV mode Respiratory rate R Rate Range 5 bpm to 60 bpm in V A C and P A C modes 1 bpm to 40 bpm in P SIMV and V SIMV modes Resolution 1 bpm Accuracy 1 bpm Default value 13 Depends on Insp Time and Vt...

Page 116: ...ult value AUTO Depends on Backup R In PSV Apnea time AUTO 60 Backup R In V SIMV or P SIMV Apnea Time AUTO 12 In CPAP Apnea Time AUTO 30 Minimum Inspired Tidal Volume Min VTI Range 30 mL to 1990mL Reso...

Page 117: ...iratory time Min I time Range 0 1 to 2 8 s Resolution 0 1 s Default value AUTO Rise time 300 ms Depends on Max I Time Backup R Rise time Maximum inspiratory time Max I time Range 0 8 to 3 s Resolution...

Page 118: ...0 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 16 Patient Circuit Resistancesa a Includes exhalation valve Adult Double Limb Pedia...

Page 119: ...ry the ventilator should be observed to verify normal operation in the configurations in which it will be used Table A 20 Electromagnetic Emissions The Puritan Bennett 560 Ventilator is intended for u...

Page 120: ...es 2 kV lines earth 1 kV lines lines 2 kV lines earth AC power mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variation...

Page 121: ...bands 10 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the ventilator including cables than the recommended separation distance calcula...

Page 122: ...e A 23 Recommended Separation Distances The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ventilator...

Page 123: ...irements for Safety 2 Collateral standard Electro Magnetic Compatibility requirements and tests IEC 60601 1 2 2007 and EN 60601 1 2 2007 Medical Electrical Equipment Part 1 General Requirements for Sa...

Page 124: ...ety and essential performance Part 2 Home care ventilators for ventilator dependent patients YY 0600 2 2007 ISO 10651 2 2004 MOD Medical electrical equipment Part 2 Particular requirements for the saf...

Page 125: ...C if the breaths are based on a volume setting P A C if the breaths are based on a pressure setting B 1 2 SIMV Modes When set to a SIMV Synchronised Intermittent Mandatory Ventilation Mode machine ini...

Page 126: ...of pressure in the patient s airway during exhalation In addition the venti lator applies a clinician set pressure Pressure Support to each of the patient s breaths This has the same benefits as CPAP...

Page 127: ...clear and legible Pass 3 Confirm the air inlet filter is clean and correctly installed Pass 4 Ensure the AC power cable does not exhibit any signs of damage such as kinks breaks or damaged insulation...

Page 128: ...C 2 User s Manual This page is intentionally blank...

Page 129: ...er do not have any dents or scratches which may indicate possible damage the ventilator s labels and markings are clear and legible the AC power cable does not exhibit any signs of damage such as kink...

Page 130: ...Unpacking and Preparation D 2 User s Manual Figure D 1 Puritan Bennett 560 Ventilator Figure D 2 Dual Bag...

Page 131: ...DISCONNECTION alarm to trigger properly Perform the following test to ensure the Low PIP alarm is properly set 1 Before proceeding set the ventilation and alarm parameters specified by the patient s c...

Page 132: ...or and the proximal pressure port refer to section 4 4 Patient Circuit 2 Block the patient wye at the end of the patient circuit Refer to Figure E 1 on page E 2 Figure E 1 Blocking the Patient End of...

Page 133: ...TERY symbol is displayed at the top of the screen along with its reserve capacity 3 Connect the AC mains power supply Ensure that the following events occur the AC POWER indicator to the upper left of...

Page 134: ...E 4 User s Manual This page is intentionally blank...

Page 135: ...and Accessories Description Carrying bag grey Oxygen inlet connector Ventilator Cart Dual Bag blue or pink delivered with Backpack Padded Straps 2 ea Suspension belt Carrying belt Warning To minimise...

Page 136: ...l formerly Barrierbac S Electrostatic Filter Small Angled Port formerly Barrierbac S Angled Adult Pediatric Electrostatic Filter HME Large formerly Hygrobac Adult Pediatric Electrostatic Filter HME Sm...

Page 137: ...rage number of apnea events per hour of ventilation It is based on the Apnea Alarm Apnea Time Time allowed between breath starts before APNEA alarm occurs when no patient effort is detected Assist Con...

Page 138: ...ontaneous breath cycle Controlled breath A volume or pressure breath triggered controlled and terminated by the ventilator DC Power Direct current Double Limb Patient Circuit Patient circuit with a tu...

Page 139: ...e patient inspires Inspiratory Sensitivity I Sens Level of inspiratory effort the patient has to provide during the initiation of a machine breath The sensitivity levels from 1P to 5 correspond to dif...

Page 140: ...a maximum limit in order to reach the target tidal volume Vt Target Mbar An abbreviation for millibar which is a unit of measure for atmospheric pressure Mean Airway Pressure Average patient pressure...

Page 141: ...ntained throughout patient inspiratory flow and is cycled to expiration by time controlled by the selected Inspiratory Time setting Used in Assist Control mode Pressure Support P Support Augmentation...

Page 142: ...ent does not make an inspiratory effort greater than the sensitivity settings and there is no apnea backup rate Standby The operational mode of the ventilator where it is powered power supply I O butt...

Page 143: ...3 10 3 17 COOLING FAN 3 10 3 18 DC POWER DISCONNECTION 3 10 3 18 4 6 DEVICE FAULT10 3 10 3 18 DEVICE FAULT11 3 10 3 18 DEVICE FAULT12 3 10 3 18 DEVICE FAULT13 3 10 3 18 DEVICE FAULT3 3 10 3 18 DEVICE...

Page 144: ...ssories 7 2 exhalation block 7 2 solutions and products approved 7 2 ventilator 7 1 CONNECT VALVE OR CHANGE PRESS alarm message 3 10 3 17 Connecting to AC power 4 2 DC power 4 4 oxygen 4 14 oxygen sup...

Page 145: ...4 3 12 3 22 6 4 LOW FIO2 alarm message 3 12 3 22 Low pressure test E 1 LOW VTE alarm message 3 12 3 23 LOW VTl alarm message 3 12 3 23 M Machine counter 5 2 Maintenance schedule recommended 8 2 Manuf...

Page 146: ...electrical A 1 environmental A 7 indicators and alarms A 3 manufacturer s declaration A 9 monitored parameters A 3 performance A 3 physical A 1 pneumatic A 8 range resolution and accuracy A 4 standar...

Page 147: ...rfaces 5 9 specifications A 1 symbols and markings 1 11 turning off 5 9 turning on 5 1 unpacking and preparation D 1 Ventilator and liquid ingress Warning 1 3 VTI NOT REACHED alarm message 3 14 3 25 W...

Page 148: ...Index Index 6 User s Manual This page intentionally blank...

Page 149: ......

Page 150: ...ationally registered trademarks of Covidien AG Trademark of its respective owner Other brands are trademarks of a Covidien company 2012 Covidien Covidien llc 15 Hampshire Street Mansfield MA 02048 USA...

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