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Regulatory compliance

D-7

So, in addition to selection of RFID systems and medical electrical equipment
and systems, EMC management includes maintaining adequate separation
distances between them.

For medical electrical equipment and systems that meet this standard, the
minimum necessary separation distances are shown in Annex J of the AIMS
standard 7351731, as well as the guidance required by standards such as IEC
60601-1-2.

For medical electrical equipment and systems that do not meet this standard,
the minimum necessary separation distances can be determined using the
guidance required by standards such as IEC 60601-1-2.

In general, the recommended minimum separation distance (d) is of the form:

where E is the RF immunity of the medical electrical equipment or system, P is
the maximum rated RF output power of the RFID system, and k is an antenna
efficiency factor. In Edition 3 of IEC 60601-1-2 [23] and earlier editions, k was
assumed to be 3.5 for frequencies less than 800 MHz and 7 at frequencies
greater than or equal to 800 MHz. In Edition 4 [24], k is assumed to be 6 for
all frequencies.

Cables That May
Affect IEC 60601-1-2
Compliance

Cables, such as remote alarm cables, longer than 3.05-m may affect the
compliance of the ventilator system with the emissions and immunity
requirements of IEC 60601-1-2.

WEEE recycling
directive

Waste electrical and electronic equipment (WEEE) recycling directive.

Waste electrical and electronic equipment must not be disposed of as unsorted
municipal waste at the end of its expected service life. It must be collected
separately and must be disposed of per local regulations. Contact your Philips
authorized representative for information concerning the decommissioning of
your equipment.

Compliant with the WEEE recycling directive.

If you are subject to the WEEE directive, refer to www.philips.com/
recycling for the passport for recycling this product.

Dispose of this device in accordance with local collections and recycling
regulations. For more information, visit www.philips.com/recycling.

This device contains a lithium ion battery that cannot be recycled. Please
contact customer service for safe disposal instructions of this part.

d

k

E

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P

=

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Содержание Respironics V60

Страница 1: ...Respironics V60 V60 Plus Ventilator User Manual ...

Страница 2: ......

Страница 3: ... 3 2 General description 3 3 Physical description 3 4 Patient circuits masks patient interfaces and accessories 3 4 Ventilator unit 3 6 About the backup battery 3 10 About the graphical user interface 3 12 Navigating the graphical user interface 3 13 Starting up the ventilator 3 15 Shutting down the ventilator 3 15 Training 3 15 4 Principles of operation 4 1 System operational overview 4 1 Pneumat...

Страница 4: ...atient Disconnect 5 10 Patient Circuit Occluded 5 10 Using the ventilator for intra hospital transport 5 11 Storing the ventilator between patient use 5 13 MRI safety information 5 13 Security and Privacy Information 5 13 6 Operation 6 1 Changing the mode 6 2 Changing control settings 6 3 Making batch setting changes 6 3 Changing individual ventilator settings 6 4 Using the Ramp Time function 6 5 ...

Страница 5: ...ing the waveform axes 8 2 Freezing and unfreezing waveforms 8 3 9 Alarms messages and troubleshooting 9 1 Responding to alarms 9 1 Setting alarm loudness 9 4 Silencing alarms 9 5 Resetting alarms 9 5 Manually resetting alarms 9 5 Clearing autoreset alarms from the Alarms list 9 5 Hiding displaying alarm messages 9 6 Symptom based troubleshooting 9 6 Alarms and other messages 9 7 10 Care and mainte...

Страница 6: ...ng the battery A 4 Installing oxygen inlet connector and AC power cord A 7 Installing the oxygen manifold kit A 9 Verifying ventilator operation and audible alarm A 9 Configuration and screen calibration A 9 B Communications interface B 1 RS 232 serial port B 2 Supported communication protocols B 2 Using Philips IntelliBridge or VueLink B 2 Using Philips monitors and the IntelliBridge or VueLink O...

Страница 7: ...ling directive D 7 Classification D 8 Safety D 8 Applied parts D 9 Accessible parts D 9 Detachable components D 9 Essential performance D 9 E Diagnostic mode E 1 Entering the diagnostic mode E 1 System settings E 3 Language E 4 Date Time E 6 Pressure Units E 7 Restore Default Settings E 8 Software Options E 9 Baud Rate E 10 Alarm Volume Escalation E 11 Service E 12 Significant Event Log E 12 Touch...

Страница 8: ...viii ...

Страница 9: ... Always have immediate access to an alternative means of ventilation If there is a ventilator failure immediately remove the ventilator from use and secure an alternative means of ventilation such as a self inflating manually powered resuscitator and mask Failure to do so can result in patient injury or death WARNING Use the Respironics V60 V60 Plus Ventilator on spontaneously breathing patients o...

Страница 10: ...se the ventilator in well ventilated areas away from flammable anesthetics Do not use in a hyperbaric chamber or other similarly oxygen enriched environments Do not use near an open flame WARNING To reduce the risk of electric shock from liquid entering the device do not put a container filled with a liquid on the ventilator WARNING To reduce patient risk of oxygen toxicity keep free flowing oxyge...

Страница 11: ...millibar equals 1 hPa which equals 1 016 cmH2O the units may be used interchangeably NOTE The ventilator is not intended for use as an ambulance transport ventilator or as an Automatic Transport Ventilator as described by the American Hospital Association and referenced by the FDA It is intended to allow the patient to be transported within the hospital setting using a cart to move the ventilator ...

Страница 12: ...d WARNING Do not use the ventilator with helium or helium mixtures The ventilator is not intended to be used with helium or heliox Connecting helium to the ventilator may affect ventilator performance gas mixtures and measurements due to the lower density of helium WARNING Do not use the ventilator with nitric oxide WARNING To prevent possible asphyxia and to reduce the risk of CO2 rebreathing tak...

Страница 13: ...WARNING To prevent possible patient injury and equipment damage do not turn the humidifier on until the gas flow has started and is regulated Starting the heater or leaving it on without gas flow for prolonged periods may result in heat build up causing a bolus of hot air to be delivered to the patient Circuit tubing may melt under these conditions Turn the heater power switch off before stopping ...

Страница 14: ... s operation time is approximate and is affected by ventilator settings discharge and recharge cycles battery age and ambient temperature WARNING Always check the status of the oxygen cylinders before using the ventilator during transport WARNING Provide external oxygen monitoring to minimize patient risk in case of O2 supply loss or ventilator failure WARNING To ensure the ventilator s safe opera...

Страница 15: ...ilters When using a nebulizer or humidifier monitor the breathing system filter frequently for increased resistance and blockage WARNING Using a jet nebulizer can cause inadvertent alarms and affect the accuracy of delivered FiO2 To reduce patient risk use only an approved nebulizer Operation in high flow therapy HFT WARNING When transitioning from a high flow therapy interface to an NIV mask ensu...

Страница 16: ...amination inspect and replace the main flow bacteria filter between patients and at regular intervals or as stated by the manufacturer WARNING To prevent possible patient injury inspect and verify the proper operation of the exhalation port regularly during use WARNING To reduce the risk of fire explosion leakage or other hazard take these precautions with respect to the battery Do not attempt to ...

Страница 17: ...ling fan filter should be cleaned CAUTION To prevent possible damage to the ventilator always ship it with the original packing material If the original material is not available contact Philips to order replacements First time installation WARNING Never attempt to disconnect or connect the battery during operation CAUTION To prevent possible damage to the ventilator always secure it to its stand ...

Страница 18: ...y remote alarm device before use WARNING To ensure the functionality of the remote alarm connect only Respironics approved cables to the remote alarm port CAUTION The remote alarm port is intended to connect only to an SELV safety extra low voltage and ungrounded system with basic insulation to ground in accordance with IEC 60601 1 To prevent damage to the remote alarm make sure the signal input d...

Страница 19: ...nce of flammable an esthetics Attention consult the accompanying documents Read the user manual before using the ventilator Symbol may be accom panied by the web address www Philips com IFU to indicate access to electronic IFUs Electronic instructions for use Indicates that relevant information for use of the product is available in electronic form Blue It is mandatory for the operator to consult ...

Страница 20: ...ting current AC Degree of fluid ingress protection provided by the enclosure drip proof Degree of solid object protection and fluid ingress protection provided by the enclosure drip proof Caution Federal law restricts this device to sale by or on the order of a physician Alarm and remote alarm Two states of control ON and Shutdown Battery European Conformity Symbol is on rear panel of ventilator T...

Страница 21: ... of manufacture Symbol accompanied by date Country of Manufacture Symbol accompanied by country code and op tionally manufacture date and or manufacturer s name and address Manufacturer Symbol accompanied by manufacturer s name and address EC representative Serial number Order number Lot or batch number Model number Use by date RS 232 serial input output USB port Table 2 1 Symbols used on ventilat...

Страница 22: ... Do not disassemble Refer to authorized service personnel Product must be disposed of in accordance with the WEEE directive Noninvasive ventilation patient with mask Invasive ventilation intubated patient The V60 V60 Plus Ventilator is MR Unsafe and presents a projectile haz ard Keep the ventilator outside MRI scan room Zone IV Table 2 1 Symbols used on ventilator labels battery and packaging Symb...

Страница 23: ...ntilator stand and accessories Hospital grade Packaging unit Symbol accompanied by a number indicating the number of pieces in the package Recycle Recycle Taiwan RoHS China Administrative Measure on the Control of Pollution Caused by Electronic Information Products Contains RoHS substances with 50 years environmentally friendly use period EFUP uR UL recognition symbol Direct current DC Symbol is o...

Страница 24: ...ceptable upper and lower limits of relative humidity for transport and storage Temperature limit Indicates the maximum and minimum temperature limits at which the item shall be stored or transported Battery included C Flex feature AVAPS mode included PPV software option Auto Trak software option High flow therapy Note 3 00 software and above HFT is optional for model V60 and included with model V6...

Страница 25: ...essage is displayed Touch to hide alarm messages Alarm message is hidden Touch to display alarm messages Do not use an NIV mask during high flow therapy 3 00 software and above and V60 Plus Increase and decrease adjustment arrow buttons Adjusts a setting or selects a value Accept button Accepts set values Cancel button Cancels set values 2 00 minutes button Adds two minutes to 100 O2 delivery ...

Страница 26: ...on Vertical autoscale button Autoscales the Y axis of the graphs to fit the data currently displayed Pause button Freezes waveforms in the Waveform window Pause in progress Resume button Resumes all waveform graphs from a paused state Time base adjust button Rescales the X axis of the graph display data at 3 6 12 and 24 second increments VE Estimated minute ventilation VT Estimated exhaled tidal v...

Страница 27: ...er minute BTPS compensated Volume milliliters User set Ramp Time Ramp graphic fills in as Ramp Time progresses Ramp Time is OFF no ramp time set Intentional leak The number corresponds to the leak symbol printed on Philips Respironics masks Table 2 2 Symbols used on graphical user interface continued Symbol Description ...

Страница 28: ...2 10 Symbols ...

Страница 29: ...dren and adolescents weighing 20 Kg 44 lb or greater and adult patients It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications The ventilator is intended to be used by qualified medical professionals such as physicians nurses and respiratory therapists The ventilator is intended to be used only with various combinations of Philips recommended...

Страница 30: ...tilation Increase EPAP to decrease the potential for CO2 rebreathing Higher pressures produce more flow through the exhalation port which helps to purge all CO2 from the circuit to prevent rebreathing Be aware that the potential for CO2 rebreathing increases as inspiratory time increases A longer inspiratory time decreases exhalation time allowing less CO2 to be purged from the circuit before the ...

Страница 31: ...which modes therapies and features are included or optional for the V60 and V60 Plus models High flow therapy HFT High flow therapy provides a set flow of mixed air and oxygen Flow and O2 percentage settings are selected by the clinician HFT is available for 3 00 software and above as well as for the V60 Plus Auto Trak Sensitivity allows the ventilator to automatically compensate for intentional a...

Страница 32: ...ptional cylinder holder the stand can accommodate two E size oxygen cylinders An oxygen manifold kit is available which allows two oxygen cylinders and one wall oxygen supply line to be used as inputs to the ventilator Communications interface The ventilator can output data through the RS 232 serial port upon receiving a command from a host computer or bedside monitoring system The ventilator is e...

Страница 33: ...General information 3 5 Figure 3 2 Respironics V60 V60 Plus Ventilator with accessories Oxygen monitor Humidifier Oxygen cylinder Patient circuit Mask Bacteria filter ...

Страница 34: ...ike this Legacy versions have both the navigation ring and Accept button and look like this The photos and illustrations throughout this manual reflect the newer version of the ventilator Accept button without navigation ring For more information on the functionality differences see Navigating the graphical user interface on page 3 13 Figure 3 3 through Figure 3 5 show the controls indicators and ...

Страница 35: ... in prescribed pressures to the patient 5 Alarm speakers beneath ventilator 6 Alarm LED Flashes during a high priority alarm On continuously during a venti lator inoperative condition 7 Battery charged LED Flashes when battery is charging On continuously when battery is charged Off when ventilator is running on battery when a battery er ror or failure is detected or when the ventilator is off and ...

Страница 36: ...eral information Figure 3 4 Side view Number Description 1 Ventilation vents Allow intake of air for delivery to the patient 2 Air inlet filter under side panel Filters the air for delivery to the patient 1 2 ...

Страница 37: ...ctor 3 Reserved for future use 4 Power cord retainer 5 Power cord 6 RS 232 serial connector female DB 25 Connects to hospital information systems and other serial devices Connects Respi Link remote diagnostic system gateway for software updates 7 Cooling fan filter 8 High pressure oxygen inlet connector 9 Option labels 8 3 1 7 3 6 5 4 3 2 9 ...

Страница 38: ... discharged The internal backup battery protects the ventilator from low or failure of AC mains power If AC power fails the ventilator automatically switches to operation on backup battery with no interruption in ventilation The battery powers the ventilator until AC power is again adequate or until the battery is depleted For electrical specifications see Table 11 10 on page 11 8 As a safeguard t...

Страница 39: ... connected to an AC outlet Figure 3 6 Power indicators ON Shutdown LED On continuously AC power is connected Battery charged LED Flashes Battery is charging On continuously Battery is charged 90 to 100 Off Ventilator is running on battery or the ventilator is off and AC power is not connected Power source symbol The ventilator is powered by AC and the battery is installed The ventilator is powered...

Страница 40: ...veforms and alarm and informational messages The lower screen lets you access modes and other ventilator settings display help information and see the power status Figure 3 7 Parts of graphical user interface 15 Window window tabs see page 6 1 Help button see page 6 22 Waveforms window see page 8 1 Patient data window see page 8 1 Power symbols see page 5 2 Alarm status bar see page 9 2 Compressed...

Страница 41: ...tilator To open a window touch the window tab To cancel a function and close the window either select Cancel or touch another window tab To adjust a parameter touch the arrow button or select the value with the navigation ring legacy versions Each touch changes the value in single increments or for parameters with wide ranges press and hold the arrow key to make faster changes The slider flag move...

Страница 42: ...acy versions also lets you adjust the position of the cursor in the waveforms window while the screen is frozen See Freezing and unfreezing waveforms on page 8 3 for more information Adjustment arrow button Slider flag Setting range scale Proposed value ...

Страница 43: ...ntilator Shut down the ventilator as follows 1 Press and release the ON Shutdown key The Shutdown window opens 2 Select Ventilator Shutdown The ventilator shuts down NOTE Improper shutdown may cause a Power has been restored message the next time the ventilator is turned on NOTE If the screen is blank and the dialogue box cannot be displayed shut down the ventilator by pressing the ON Shutdown key...

Страница 44: ...3 16 General information ...

Страница 45: ...aphical user interface The ventilator s gas delivery and monitoring functions are cross checked This cross checking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of system failure A comprehensive system of visual and audible alarms helps ensure the patient s safety Clinical alarms can indicate an abnormal physiological condition Technical alarms ...

Страница 46: ...sk or ET tube A pressure tap proximal to the patient is used to monitor patient pressure The exhalation port continually exhausts gas from the circuit during inspiration and exhalation to minimize rebreathing and ensure CO2 removal Breath delivery characteristics Control variable Breaths delivered by the Respironics V60 V60 Plus Ventilator are pressure controlled In the AVAPS mode the ventilator s...

Страница 47: ...sence of leaks This is called Auto Trak Sensitivity The following subsections describe this function in detail Triggering Breaths are patient flow triggered in all modes typically when patient effort causes a certain volume of gas to accumulate above baseline flow volume method An inspiration is also triggered when the patient inspiratory effort distorts the expiratory flow waveform sufficiently s...

Страница 48: ...low signal crosses the shape signal this results in a trigger or a cycle As a result a sudden decrease in expiratory flow from an inspiratory effort will cross the shape signal and create a signal for ventilator triggering Figure 4 2 Shape signal SET method of cycling Patient flow reaches the spontaneous exhalation threshold SET see Figure 4 3 The SET represents the intersection of the flow wavefo...

Страница 49: ...entilator adjusts its baseline flow Because the unintentional part of the leakage may constantly change the ventilator recalculates the baseline flow each breath at the end of exhalation The ventilator uses two main mechanisms to update its baseline flow expiratory flow adjustment and tidal volume adjustment Expiratory flow adjustment Every breath at end exhalation the ventilator updates its flow ...

Страница 50: ...iple trigger and or cycle thresholds simultaneously retaining all the auto adaptive features of Auto Trak Sensitivity The Normal Auto Trak settings work well for most patients Pediatric patients however may benefit from more sensitive trigger settings while some adult patients may benefit from more or less sensitive cycle settings High flow therapy High flow therapy HFT enables delivery of a humid...

Страница 51: ...aracteristics of these modes Note that on the ventilator the Timed breath indicator means the breath is ventilator triggered while the Spont breath indicator means the breath is patient triggered Table 4 1 Characteristics of Respironics V60 V60 Plus ventilation modes Mode Timed breaths Spont breaths Trigger A trigger variable starts inspiration Limit A limit variable can reach and maintain a prese...

Страница 52: ...entilator s Auto Trak Sensitivity algorithms The control settings active in the CPAP mode are shown in Figure 4 6 Figure 4 7 shows CPAP mode waveforms The C Flex feature setting enhances traditional CPAP by reducing the pressure at the beginning of exhalation a time when patients may be uncomfortable with CPAP and returning it to the set CPAP level before the end of exhalation Figure 4 6 CPAP cont...

Страница 53: ...nes the applied inspiratory pressure for all breaths If the patient fails to trigger a breath through Auto Trak within the interval determined by the rate setting the ventilator triggers a mandatory breath The I Time setting is the cycle criterion for all breaths Figure 4 9 shows a PCV mode pressure waveform Figure 4 8 PCV controls Figure 4 9 PCV pressure waveform Pressure EPAP IPAP I Time 1 Rate ...

Страница 54: ...nterval determined by the Rate setting the ventilator triggers a mandatory breath with the set I Time The patient triggers and cycles based on the ventilator s Auto Trak Sensitivity algorithms The control settings active in the S T mode are shown in Figure 4 10 Figure 4 11 shows an S T mode pressure waveform Figure 4 10 S T controls Figure 4 11 S T pressure waveform Pressure EPAP IPAP I Time 1 Rat...

Страница 55: ...pontaneous breaths If the patient fails to trigger a breath within the interval determined by the Rate control the ventilator triggers a mandatory breath with the set I Time Mandatory and spontaneous breaths are delivered at a pressure that is continually adjusted over a period of time to achieve the volume target VT Min P and Max P define the minimum and maximum pressures that can be applied The ...

Страница 56: ...4 12 Principles of operation Figure 4 13 AVAPS waveforms Volume Flow Pressure Max P Min P VT EPAP 1 Rate I Time Mandatory Timed breath Patient triggered Spont spontaneous breath Rise Time ...

Страница 57: ... airway pressure is the net result of this contraction of these muscles it is the force of the inspiratory muscle contraction minus both the pressure needed to generate air flow overcome respiratory system resistance and the pressure generated to inflate the lungs overcome respiratory system elastance How PPV works The delivery of a PPV breath is controlled by the maximum elastance volume assist M...

Страница 58: ...14 Figure 4 14 PPV controls Figure 4 15 shows PPV mode waveforms Note how volume and pressure increase as does the ventilatory demand of the patient Max V PPV maximum volume limit and Max P PPV maximum pressure limit are used to prevent the delivery of excessive pressure or volume More information about these limits is provided in About Max V and Max P alarms and alarm limits on page 6 7 Figure 4 ...

Страница 59: ... flow the ventilator provides additional air flow from the blower to ensure the target pressure is met Under such conditions the accuracy of delivered oxygen may be affected Figure 4 16 shows the effect on the delivered oxygen concentration as the maximum oxygen system flow is exceeded This graph assumes a continuous flow demand Normally the higher peak flow is only needed during inspiration so th...

Страница 60: ...4 16 Principles of operation ...

Страница 61: ...wing oxygen away from air inlet of ventilator CAUTION To prevent possible damage to the ventilator ensure that the connection to the oxygen supply is clean and unlubricated and that there is no water in the oxygen supply gas Connect the oxygen hose to an appropriate high pressure oxygen source using country specific O2 connectors as applicable Use of SIS connectors and supplemental oxygen accessor...

Страница 62: ...ilator on The retainer is designed to hold the connector end of the Philips supplied cord securely in place WARNING To reduce the risk of electric shock regularly inspect the AC power cord and verify that it is not frayed or cracked WARNING To reduce the risk of strangulation route the power cord to avoid entanglement CAUTION For 120 V equipment grounding reliability can only be achieved when it i...

Страница 63: ... ventilation patient exhalate is released into room air Use of a patient circuit with a filter on its exhalation port is recommended WARNING To reduce the risk of bacterial contamination or damage handle bacteria filters with care WARNING Avoid adding any components to the patient circuit that are not absolutely necessary Additional components installed in the patient circuit can change the pressu...

Страница 64: ...ation or high flow therapy For details on high flow therapy setup see High flow nasal cannula setup on page 7 2 Figure 5 2 and Figure 5 3 show circuit configurations for noninvasive and invasive ventilation Follow the manufacturers instructions for use for the individual parts Installing the nebulizer For installation of the Aerogen nebulizer follow the manufacturer s instructions that came with t...

Страница 65: ... high flow therapy when using the AC611 high flow nasal cannula with FEP Connector to block the exhalation port Figure 5 1 Patient circuit with heated wire and humidification for noninvasive ventilation or high flow therapy Proximal pressure line Ventilator outlet Bacteria filter Proximal pressure port Humidifier Oxygen sensor tee ...

Страница 66: ...or use NOTE This circuit setup is recommended for noninvasive ventilation Figure 5 2 Noninvasive patient circuit without humidification Proximal pressure line Ventilator outlet Bacteria filter Proximal pressure port Oxygen sensor tee ...

Страница 67: ...lator can communicate with a Philips patient monitor using the IntelliBridge Open Interface See Using Philips monitors and the IntelliBridge or VueLink Open Interfaces on page B 2 The ventilator also supports the VueLink Open Interface VueLink has been replaced by IntelliBridge but information is included in this manual for backwards compatibility See Data display on page B 3 For more information ...

Страница 68: ...ended to be a primary power source NOTE We recommend that the ventilator s batteries be fully charged before you ventilate a patient If the batteries are not fully charged and AC power fails always pay close attention to the level of battery charge Verify ventilator operation 1 Ensure that the ventilator is connected to AC power 2 Power on the ventilator The ventilator automatically runs a test of...

Страница 69: ... always return alarm settings to hospital standard values after verifying ventilator operation Preparation 1 Set the ventilator up as for normal ventilation complete with breathing circuit PN 582073 or the equivalent and a 1 liter test lung assembly PN 1021671 2 Set the mode to S T and make the following control settings Rate 4 BPM IPAP 10 cmH2O EPAP 6 cmH2O I Time 1 sec Rise 1 Ramp Off O2 21 3 Ma...

Страница 70: ...ct the test lung 2 VERIFY that the Patient Disconnect alarm is activated 3 Reconnect the test lung 4 VERIFY that the alarm resets and that the ventilator automatically resumes ventilation Patient Circuit Occluded 1 Disconnect the patient circuit including bacteria filter from the ventilator outlet and block the ventilator outlet 2 VERIFY that the Patient Circuit Occluded alarm is activated 3 Unblo...

Страница 71: ...175 SLPM WARNING Do not leave the ventilator unattended when stationed on an incline Do the following to conserve oxygen during transport with the ventilator Make sure all cylinders are full 13 790 kPa 2000 psig or more Make sure the cylinder regulators are turned off while the ventilator is connected to wall oxygen Never turn the cylinder regulator on until you are ready to begin transport Only t...

Страница 72: ...O Leak of 10 L min Leak of 20 L min Leak of 30 L min Leak of 40 L min FIO2 0 10 20 30 40 50 60 70 80 90 Duration min 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 b VT 500 mL Rate 20 BPM EPAP 6 cmH2O IPAP 18 cmH2O 20 40 60 80 100 120 140 0 Duration min Leak of 10 L min Leak of 20 L min Leak of 30 L min Leak of 40 L min Leak of 50 L min 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 FIO2 ...

Страница 73: ...entilator MRI safety information WARNING The V60 V60 Plus Ventilator is MR Unsafe Keep it outside the MRI scan room Zone IV It represents a projectile hazard Security and Privacy Information To develop a security strategy related to the use of the ventilator refer to the Hospital Respiratory Care product security guide Download it from www philips com hrcmanuals ...

Страница 74: ...5 14 Setting up the ventilator for use ...

Страница 75: ...the ventilator as instructed in Chapter 5 NOTE Any mode and settings can be used for closed suctioning After power on the ventilator starts up in the mode and with the settings that were active before last power down Check these settings and adjust as required You must be familiar with using the touchscreen and navigation ring legacy versions to select adjust activate and confirm parameters For de...

Страница 76: ...reen Change the mode as follows For details on modes see Ventilation modes on page 4 7 1 Open the Modes window 2 Select the desired mode 3 Adjust settings as desired see Changing individual ventilator settings on page 6 4 Newly adjusted setting values are shown in yellow 4 Select Activate Mode to apply Active mode ...

Страница 77: ...s on page 4 7 Making batch setting changes The ventilator allows you to make multiple changes a batch of changes at once NOTE During a batch setting change you cannot change the Ramp Time setting when a ramp is active This process applies to ventilation settings only not to alarm settings 1 Open the Modes window 2 Select the active mode 3 Adjust settings as desired see Changing individual ventilat...

Страница 78: ...he Settings window 1 Open the Settings window 2 Select the desired setting As an example we will show the IPAP adjustment 3 The setting window opens Adjust the setting Select Accept to apply Adjustment arrow button Current settings area Setting range scale Additional information Proposed value ...

Страница 79: ...w these instructions to use the Ramp Time function 1 Select the Ramp Time button in the Settings window The ramp starts As the ramp progresses the Ramp Time button graphic fills in 2 To change the ramp interval or to end the ramp select the Ramp Time button again The Ramp in Progress window opens 3 To end the ramp and apply the full IPAP and EPAP CPAP immediately select End Ramp 4 To end the ramp ...

Страница 80: ...n to the patient It is available during Screen Lock status Follow these instructions to use the 100 O2 function 1 Select the 100 O2 button in the main GUI window 2 The ventilator delivers 100 oxygen for two minutes A countdown timer displays While 100 oxygen delivery is active you can press the 2 00 button to add two minutes more Press Cancel to stop ...

Страница 81: ...mit and Max P PPV maximum pressure limit are used to prevent the delivery of excessive pressure or volume WARNING PPV limits are not intended to be the primary ventilator alarms and should not be substituted for the alarms found in the Alarm Settings window WARNING To prevent the delivery of excessive pressure or volume set the PPV limits appropriately Delivery of excessive pressure or volume can ...

Страница 82: ...ved patient status It may however indicate that the patient is more actively breathing possibly due to agitation or a change in the patient s level of sedation It may also indicate an increase in leakage The VT estimated exhaled tidal volume measurement may remain below the set Max V limit even though the inspired volume exceeds Max V This results from variable leakage which reduces the exhaled vo...

Страница 83: ...tance Titrate both Max R and Max E settings Suggested titration procedure Follow this procedure to titrate settings to optimize patient comfort while avoiding overassisting See also the flow chart in Figure 6 3 NOTE You may also need to adjust PPV according to patient response as you do for the other PPV settings described below Mask leakage especially a sudden increase is interpreted as patient e...

Страница 84: ...t is reached The mask leak has suddenly increased b If none is true increase Max E in increments of 2 cmH2O L while continuing to evaluate the patient s response c If any is true decrease Max E by 2 cmH2O L and re evaluate Repeat to optimize patient comfort 3 Repeat the process above adjusting Max R increasing and decreasing in increments of 1 cmH2O L s to optimize patient comfort 4 Repeat adjustm...

Страница 85: ... suddenly increased No No No Increase Max E by 2 cmH2O L Yes Yes Yes No Does the patient say the air is coming too fast Is the patient using accessory muscles to ac tively stop inspiration Was the Max V or Max P limit reached Has the mask leak suddenly increased No No Increase Max R by 1 cmH2O L s Reduce Max R by 1 cmH2O L s for patient comfort Yes Yes Yes Yes No End Titrate PPV downward as tolera...

Страница 86: ...tings window 2 Select the desired setting adjust it and select Accept to apply The ventilator annunciates an alarm when a monitored value goes out of the range bounded by the alarm limits Selecting the mask and exhalation port To be able to display full leakage data plus accurate tidal and minute volumes the ventilator must know the intentional leak characteristics of the specific mask patient int...

Страница 87: ...symbol is printed on Respironics masks Description ET Trach ET or tracheostomy tube Leak 1 Mask with minimal intentional leak characteristics En ter Leak 1 for any of these Philips Respironics masks Contour Deluxe nasal mask PerformaTrak mask AF531 AF541 EE Leak 2 Mask with medium intentional leak characteristics En ter Leak 2 for this mask Philips Respironics PerforMax oro nasal mask EE AF531 AF5...

Страница 88: ...rt that is not compatible with the selected mask Not allowed with current mask is displayed NOTE In ventilation modes ET tracheostomy tubes and most Philips Respironics masks require the use of an exhalation port If you selected ET Trach or Leak 1 as a mask patient interface you may not select None as an exhalation port ...

Страница 89: ... 6 2 Exhalation port selections Port type Exhalation port test recommended FEP Philips Respironics Filtered Exhalation Port No DEP Philips Respironics Disposable Exhalation Port No Whisper Swivel Philips Respironics Whisper Swivel No PEV Philips Respironics Plateau Exhalation Valve Yes Other Exhalation port not supplied by Philips Respi ronics Yes None No inline circuit exhalation port NOTE If you...

Страница 90: ...ts window is automatically displayed when PEV or Other is selected Procedure Run the test as follows 1 Disconnect the patient circuit from the mask patient interface 2 Occlude the circuit outlet Select Start Test 3 Wait while the test runs 4 Verify that Test Passed is displayed Progress bar ...

Страница 91: ...s the Menu window From the Menu window you can adjust user preferences Brightness Use Brightness to adjust the screen for optimum daytime or nighttime viewing Loudness WARNING Set the alarm loudness above the ambient level Setting the alarm loudness too low may prevent recognition of alarm conditions WARNING Avoid blocking the alarm speakers beneath the ventilator Use Loudness to adjust the volume...

Страница 92: ...p Tabs are grayed out as in this example This message bar is displayed at the top of the screen To unlock the screen press the Accept button on the top right front of the ventilator NOTE If Screen Lock is active the touchscreen remains locked even if an alarm becomes active Auto Trak The Normal Auto Trak settings work well for most patients Pediatric patients however may benefit from more sensitiv...

Страница 93: ... to the pressure time graphic which represents the effect on I Time Select Accept to apply When Auto Trak is active when either Trigger or E Cycle is set to a value other than Normal the ventilator setting window displays Auto Trak Additionally after power on the Messages list displays the Auto Trak settings for 5 minutes Proposed value Auto Trak active ...

Страница 94: ...ffective when you exit standby Enter standby as follows 1 Select Standby The Entering Standby window opens NOTE Remove the mask patient interface in order to enter standby The ventilator will not enter standby with a patient connected If the patient is not disconnected the ventilator continues breath delivery while waiting for the patient to be disconnected The standby mode request cancels in 60 s...

Страница 95: ...r enters standby and displays the Standby screen 3 To resume ventilation reconnect the patient When the ventilator senses a patient breathing effort ventilation automatically resumes in the previous mode NOTE You can also manually resume ventilation with the Restart Mode button ...

Страница 96: ...6 22 Operation Help function Select the help button to display additional information Help messages are displayed Help message ...

Страница 97: ...iratory Cycle Sensitivity Auto Trak employs several algorithms to determine the point at which the ventilator cycles into exhalation This setting adjusts all algorithms simulta neously At the lowest setting 2 inspiration terminates later resulting in the longest in spiratory time At the highest setting 6 inspiration terminates earlier resulting in the shortest inspiratory time Normal is the Auto T...

Страница 98: ...olume set the PPV limits appropriately Delivery of excessive pressure or volume can occur from a sudden increase in mask leak inappropriate settings or a plugged or kinked proximal pressure line Conversely insufficient treatment may result if limits are set too low 5 to 40 cmH2O Max R The maximum resistance flow assist value used by the PPV mode to overcome pulmo nary resistance See also PPV setti...

Страница 99: ...nt anxi ety OFF 5 to 45 min Rate Respirato ry Rate Respiratory frequency or number of breaths per minute Inverse ratio ventilation is not allowed 4 to 60 BPM Rise Rise Time Speed with which inspiratory pressure rises to the set target pressure If the Rise Time is insufficient to reach the target IPAP pressure adjust the Rise Time or I Time setting 1 to 5 1 is fast est Table 6 3 Modes and control s...

Страница 100: ...olume to be delivered during inspiration The ventilator meets this target by adjusting the inspiratory pressure with each breath Applies in AVAPS mode only 200 to 2000 mL Table 6 3 Modes and control settings with ranges continued Setting Description Range Table 6 4 Alarm settings Setting Description Range Hi Rate High Rate Alarm High total breath rate 5 to 90 BPM Lo Rate Low Rate Alarm Low total b...

Страница 101: ...wo pressure levels It will also alert the clinician to pressure degradation due to excessive leaks See figure below LIP T Low Inspiratory Pres sure Delay Time The interval from the detec tion of low inspiratory pres sure until the alarm becomes active 5 to 60 secs Lo E Low Minute Ventila tion Alarm Low expiratory minute vol ume OFF to 99 0 L min Table 6 4 Alarm settings continued Setting Descripti...

Страница 102: ...6 28 Operation ...

Страница 103: ...rcarbia due to the inability to provide pressure support WARNING Patient alarms are not available during high flow therapy HFT as the therapy uses an open system A high flow nasal cannula occupies only a portion of the nares and patients can breathe through their mouth which prevents estimation of patient parameters such as tidal volume respiratory rate pressure and minute ventilation Provide exte...

Страница 104: ...High flow nasal cannula setup 1 Insert the AC611 high flow nasal cannula with FEP Connector into the FEP making sure the perforations in the port are completely blocked Figure 7 1 High flow nasal cannula using the FEP Connect 2 Disconnect the proximal pressure line from the ventilator port 3 Leave the other end of the proximal pressure line connected to the FEP and anchor the tubing to the breathi...

Страница 105: ...uctions in this chapter Immediately after starting HFT disconnect the proximal pressure line from the ventilator Changing from high flow therapy HFT to ventilation Follow the instructions in this chapter Immediately before activating ventilation reconnect the proximal pressure line to the ventilator Proximal pressure line Proximal pressure port FEP Tubing clips ...

Страница 106: ...ging from an NIV mode to high flow therapy Follow these instructions to use the V60 V60 Plus Ventilator for high flow therapy HFT 1 Select Standby The Entering Standby window opens 2 Remove the patient mask or ET interface to enter Standby 3 Install a Philips approved high flow nasal cannula Figure 7 1 and Figure 7 3 above or a high flow tracheostomy interface on the patient circuit 4 Select HFT F...

Страница 107: ...ive message is displayed during HFT 8 Apply the HFT interface to the patient 9 Note the low priority alarm stating that patient alarms are disabled during HFT Press alarm reset to confirm this message Viewing and pausing the HFT graph A flow graph is displayed during high flow therapy Press the Pause button to view an event ...

Страница 108: ... mask 6 Review patient settings and alarms 7 Install the appropriate interface on the patient 8 Verify that the ventilator detects the patient s breath to activate ventilation or press the Start Mode button HFT alarms and messages Table 7 1 is a list of alarms and other messages displayed by the ventilator along with descriptions suggested corrective actions and other information The ID identifier...

Страница 109: ...onfirm and clear the audible alarm Low Infor mation 68 Yes No Yes Patient Circuit Oc cluded Displays when HFT high flow therapy is active Gas flow to the patient is obstructed Check the patient Check that an occlusive interface is NOT in use a cannula fully sealed within the na res an NIV mask or direct connect to an ETT trach Check for an occlusion kink or liquid in the pa tient circuit If proble...

Страница 110: ...7 8 High flow therapy ...

Страница 111: ...re 8 1 Patient data and waveform window Display conventions The following symbols may be displayed in place of numeric values Data is not valid and or ventilator is in standby mode or disconnected Data is over range Data is under range Numeric patientdata window Vertical autoscale button Pause button Time base adjust button Waveform window Cursor Time scale adjustable Breath phase trigger indicato...

Страница 112: ...hs over the last 15 minutes Rate Respiratory rate or total breathing frequency Moving average over the last 6 breaths or 15 seconds TI TTOT Inspiratory duty cycle or inspiration time divided by total cycle time Moving average over the last 8 breaths Tot Leak Estimated total leak Average during the previous breath cycle Displayed before a suitable exhalation port and mask patient interface are sele...

Страница 113: ...s symbol The graphic display is then frozen and the cursor is visible in the middle of the display Figure 8 2 Reposition the cursor by touching the waveform screen or with the navigation ring legacy versions Data values at cursor location for pressure flow and volume are displayed in the white boxes Unfreeze the waveforms with the resume button Figure 8 2 Waveform window with frozen screen Resume ...

Страница 114: ...8 4 Patient monitoring ...

Страница 115: ...nciates for at least 2 minutes Immediately discontinue ventilator use and secure an alternative means of ventilation As in most ventilators with passive exhalation ports when power is lost sufficient air is not provided through the circuit and exhaled air may be rebreathed NOTE If an alarm persists for no apparent reason discontinue ventilator use and contact Philips Respond to an alarm as follows...

Страница 116: ...ve Autoreset alarm strikeout line through message Alarms Messages list Up to 7 entries prioritized from high to low and with any informational messages on the bottom Alarm status bar active alarm status Up arrows indicate that you can hide message in Alarms Messages list Alarm LED Alarm status bar nonalarm status No active alarms Active alarms Active mode feature bar ...

Страница 117: ...olor Alarm icon Repeating se quence of 5 tones Respond immediately to ensure patient safety Trou bleshoot as per Table 9 3 On High prior ity alarm Check Vent Respond immediately to ensure patient safety Do not use equipment that is malfunctioning or that indi cates a potential problem until the problem is cor rected Troubleshoot as per Table 9 4 High prior ity alarm Vent Inop erative On contin uou...

Страница 118: ...9 4 Alarms messages and troubleshooting Figure 9 2 Vent Inoperative screen Setting alarm loudness You can set the alarm loudness from the Menu window see Loudness on page 6 17 ...

Страница 119: ...ated the following is shown Resetting alarms Most alarms reset themselves autoreset when the alarm triggering condition is removed but you must manually reset others Table 9 3 specifies whether an alarm is autoreset Manually resetting alarms Manually reset an alarm by selecting Alarm Reset When an alarm is manually reset the message is cleared from the Alarms list any other alarm indications are r...

Страница 120: ...operative alarm see Table 9 5 on page 9 16 The touchscreen is unresponsive or does not respond properly The ventilator continues to function at the selected settings Patient settings and patient data continue to be visible and ac curate and alarms continue to be annunciated Check the patient If the patient requires a setting change provide alternative ventilation Have the ventilator serviced NOTE ...

Страница 121: ... 62 No Yes N A Bacteria filter must be installed onto gas outlet An inspiratory bacteria fil ter must be installed on the patient gas outlet port Confirm that a bacteria fil ter is installed Install a bacteria filter if one is not present Infor mation 67 Yes N A N A Cannot Reach Target Flow Displays when HFT high flow therapy is active In dicates that flow target is not achieved Check the patient ...

Страница 122: ...ings are appropriate If problem persists provide alternative ventilation Have the ventilator ser viced High 46 Yes Yes Yes Low Internal Battery Battery can provide oper ating power for only an ad ditional 15 minutes under nominal conditions Au toresets when ventilator is connected to AC power Connect ventilator to AC power Provide alternative ventilation High 43 No Yes No Low Leak CO2 Re breathing...

Страница 123: ...ating to a high priority alarm in 60 sec A high priority alarm from the start if The Lo Rate setting is 4 BPM and there are no breaths for 60 Lo Rate setting The Lo Rate setting is 4 BPM and there are no breaths for 15 sec Check the patient Con firm ventilator and alarm settings are appropriate If problem persists provide alternative ventilation Have the ventilator ser viced Low High 55 Yes Yes Ye...

Страница 124: ...ilation Have the ven tilator serviced High 40 Yes Yes Yes Patient Circuit Oc cluded Displays when HFT high flow therapy is active Gas flow to the patient is obstructed Check the patient Check that an occlusive interface is NOT in use a cannula fully sealed within the na res an NIV mask or direct connect to an ETT trach Check for an occlusion kink or liquid in the pa tient circuit If problem persis...

Страница 125: ...e is great er than the PPV maximum volume alarm limit Possi ble causes are excessive patient inspiratory effort a significant change in the leak around the patient in terface or high PPV Max E or Max R setting Ventilator cycles to exha lation At first an information message If condition per sists for three consecu tive PPV inspirations this escalates to a high priority alarm Check the patient Con ...

Страница 126: ...as re quired Infor mation 61 Yes Yes N A Vent Inoperative x description of failure See Table 9 5 on page 9 16 Table 9 4 Check Vent alarm messages summary and troubleshooting Message Description Corrective Action Priority type ID Manually resettable Autores ettable Silence able Check Vent 1 8 V Supply Failed Technical failure Check the patient Provide alternative ventilation Have the ventilator ser...

Страница 127: ...igh 5 Yes No No Check Vent Barome ter Calibration Data Error Default barometric pressure of 686 0 mmHg approximately 900 m 2953 ft above sea level used in cal culations Check the patient Provide alternative ventilation Have the ventilator serviced High 18 Yes No No Check Vent Barome ter Sensor Range Er ror Default barometric pressure of 686 0 mmHg approximately 900 m 2953 ft above sea level used i...

Страница 128: ...nt Provide alternative ventilation Have the ventilator serviced High 37 Yes No No Check Vent Internal Temperature High CPU Technical failure Check the patient Check for causes of overheating such as high room temperature blocked vents clogged air inlet filter or nonfunctional fan Provide alternative ven tilation Have the ventilator serviced High 30 Yes No No Check Vent Internal Temperature High Da...

Страница 129: ...ent Provide alternative ventilation Have the ventilator serviced High 17 Yes No No Check Vent OVP Circuit Failed Technical failure Check the patient Provide alternative ventilation Have the ventilator serviced High 38 Yes No No Check Vent Oxygen Device Failed Continues to ventilate with air only Check the patient Provide alternative ventilation Have the ventilator serviced High 16 Yes No No Check ...

Страница 130: ...tilator is in the ven tilator inoperative state Check the patient Provide al ternative ventilation Have the ventilator serviced High 2 No No No Vent Inoperative 1001 12 V Supply Failed Technical failure The ventilator is in the ven tilator inoperative state Check the patient Provide al ternative ventilation Have the ventilator serviced High 3 No No No Vent Inoperative 1002 Blower Tempera ture Too ...

Страница 131: ...cal failure The ventilator is in the ven tilator inoperative state Check the patient Provide al ternative ventilation Have the ventilator serviced High 10 No No No Vent Inoperative 1009 Pressure Regula tion High Technical failure The ventilator is in the ven tilator inoperative state Check the patient Provide al ternative ventilation Have the ventilator serviced High 11 No No No Vent Inoperative 1...

Страница 132: ...9 18 Alarms messages and troubleshooting ...

Страница 133: ...TE Cleaning and disinfection are most effective if soiling is not allowed to dry on a medical device 1 NOTE Disinfection is most effective on medical devices that were previously cleaned 1 NOTE For all V60 V60 Plus hardware accessories recommended by Philips follow the cleaning and disinfection guidelines in this chapter For multi patient interface and circuit accessories consult the product instr...

Страница 134: ... NOTE Use of unapproved cleaning and disinfecting agents may cause damage to the enclosure touchscreen or parts of the ventilator Approved cleaning agents The following cleaning agent is acceptable for use on the touchscreen and exterior surfaces of the ventilator Medivators Intercept Detergent per manufacturer s recommendation at 1 3 oz 10 mL per gallon of warm tap water Cleaning instructions 1 A...

Страница 135: ...or parts of the ventilator Approved disinfecting agents The following disinfecting agents are acceptable for use on the touchscreen and exterior surfaces of the ventilator Disinfection instructions 1 Ensure that cleaning was done per the procedure in Exterior and touchscreen cleaning on page 10 2 2 Apply disinfecting agent to a soft lint free cloth or use a disposable wipe The cloth or wipe should...

Страница 136: ...regular intervals or as stated by the manufacturer WARNING To prevent possible patient injury inspect and verify the proper operation of the exhalation port regularly during use CAUTION Because some environments cause a quicker collection of lint and dust than others inspect the filters more often when needed The air inlet filter should be replaced the cooling fan filter should be cleaned CAUTION ...

Страница 137: ...0 2 Schedule of preventive maintenance Frequency Component Maintenance Between patients and per institu tional guidelines Patient circuit Per manufacturer recommendations Main flow bacteria filter Replace per institutional guidelines Every month Cooling fan filter Inspect for occlusions dust lint etc If discol ored or dirty remove and wash or rinse thor oughly and let dry completely before reinsta...

Страница 138: ...e 2 Turn the captive D ring fastener counter clockwise one quarter turn and release Remove the side panel 3 Remove the inlet filter by pinching it out of the recess in the bracket 4 Install a new air filter by tucking it into the recessed area Replace the side panel and push in and turn the D ring fastener one quarter turn until it locks Figure 10 1 Replacing the air inlet filter Air inlet filter ...

Страница 139: ...oam filter and the filter retaining cover Figure 10 2 2 Gently pry the filter cover from the back of the ventilator Do not remove the fan retaining pins 3 Wash or rinse the filter Let it dry completely before reinstalling 4 Replace the filter then snap the filter cover into place Figure 10 2 Replacing the cooling fan filter Filter cover Foam filter Fan Do not remove Fan retaining pin Do not remove...

Страница 140: ...ctions of this part Storage between patient use Follow the steps below when storing the ventilator between patient use 1 Ensure that the patient circuit is assembled and installed properly as described in Installing the patient circuit on page 5 3 2 Plug the ventilator into an AC outlet and verify that the power source symbol is displayed 3 Adjust settings to hospital defaults 4 Check oxygen cylin...

Страница 141: ...not available contact Philips to order replacements NOTE Transport of lithium ion batteries is strictly controlled by international regulations and laws Do not ship the battery either in the ventilator or separately by sea or air Remove the battery from the ventilator before shipping the ventilator See Installing the battery on page A 4 for more information Ship the battery and ventilator separate...

Страница 142: ...10 10 Care and maintenance ...

Страница 143: ...H2O 2 cmH2O 4 of target 4 cmH2O Flow High flow therapy 3 00 software and above and V60 Plus 10 to 80 L min 5 L min N A 35 L min IPAP 4 to 40 cmH2O 1 cmH2O 2 cmH2O 4 of target 12 cmH2O I Time Inspiratory Time 0 30 to 3 00 sec 0 05 sec 0 03 sec 1 00 sec Max E 0 to 100 cmH2O L 1 cmH2O L N A 15 cmH2O L Max P PPV Maximum Pressure Limit 5 to 40 cmH2O 1 cmH2O 2 cmH2O 4 of target 20 cmH2O Max P AVAPS Maxi...

Страница 144: ...tting ranges resolutions and accuracies continued Parameter Range Resolution Performance Accuracy Factory default Table 11 2 Controls active in Respironics V60 V60 Plus ventilation modes CPAP S T PCV AVAPS PPV Timing Rate Rate I Time I Time Baseline pressure CPAP EPAP Inspiratory pres sure IPAP Max P Max P Min P IPAP Rise Time Rise Rise O2 O2 Volume VT Max V Ramp feature Ramp Time Mode specific C ...

Страница 145: ...mH2O Pt Leak 0 to 200 L min BTPS 1 L min N A Pt Trig 0 to 100 1 10 Rate 0 to 90 BPM 1 BPM 1 BPM TI TTOT 0 to 91 1 5 Tot Leak 0 to 200 L min BTPS 1 L min N A E 0 to 99 0 L min BTPS 0 1 L min 15 or 0 3 L min whichev er is greater VT 0 to 3500 mL BTPS 1 mL 15 for volumes above 200 mL Note Accuracy specification was measured with patient circuit PN 582073 Waveform window P waveform 0 to 50 cmH2O Time ...

Страница 146: ...O 1 cmH2O 50 cmH2O LIP Low Inspiratory Pressure Alarm OFF 1 to 40 cmH2O 1 cmH2O OFF Lo E Low Minute Ventilation Alarm OFF 0 1 to 99 0 L min BTPS 0 1 L min OFF LIP T Low Inspiratory Pressure Delay Time Alarm 5 to 60 sec 1 sec 20 secs V Table 11 5 Menu window settings and ranges Parameter Range Brightness 1 to 5 Loudness 1 to 10 Mask ET Selection ET Trach 1 2 3 4 Other Exhalation Port Selection FEP ...

Страница 147: ...nçais Deutsch Italiano Por tuguês Español Dansk Suomi Norsk Svenska Chi nese Japanese Türkçe Date Time Pressure Units cmH2O hPa Restore Default Settings Software Options Baud Rate 9 600 19 200 115 200 Alarm Volume Escalation Available in Revision 2 30 software and above Enable Disable default Significant Event Log Touch Screen Calibration ...

Страница 148: ...ircuit with mask O2 mani fold with hoses remote alarm cable and power cord Weight 64 kg 142 lb Maximum load Mass weight of the V60 V60 Plus ventilator stand including its safe working load 70 5 kg 155 lb 39 4 cm 15 5 in 42 9 cm 16 5 in 33 7 cm 13 3 in Table 11 8 Environmental specifications Parameter Specification Temperature Operating 5 to 40 ºC 41 to 104 ºF Storage transport 20 to 50 ºC 4 to 122...

Страница 149: ...e oxygen supply using V60 V60 Plus manifold Connector DISS male DISS female NIST Pressure 3 10 to 6 00 bar 310 to 600 kPa 45 to 87 psig Flow 175 SLPM Connector SIS Pressure 3 66 to 6 00 bar 366 to 600 kPa 53 to 87 psig Flow 175 SLPM Air supply Integrated blower Inspiratory outlet to patient port Connector ISO 15 mm female 22 mm male conical Maximum limited pressure PLIMmax 64 cmH2O Maximum working...

Страница 150: ... 14 4 V 11 0 Ah 163 Wh Maximum system current draw 11 A Charge voltage 16 9 V maximum Operating time 360 minutes 6 hours under normal conditions Table 11 11 Accessory Requirements Parameter Specification Compliance For volume accuracy requirements the patient circuit compliance should be 0 98 mL cmH2O For all other performance requirements except volume accuracy the maximum compliance of the circu...

Страница 151: ...t alarm 15 s Low Inspiratory Pressure LIP alarm user configurable from 5 to 60 s Check vent Blower temperature high 10 minutes Mean delay or the sum of mean delays from the triggering event to the generation of an alarm sig nal All alarms except those listed below 5 s Cooling fan failure alarm 10 s Blower temperature alarm 10 s ADC wraparound 6 s Audio alarm loudness In accordance with 3rd Edition...

Страница 152: ...Maximum time required for the O2 concentration in the deliv ered volume to change from a volume fraction of 21 to 90 using the worst case ventilator breathing system or using the maximum internal volume venti lator breathing system The ventilator adjusts O2 within one breath FiO2 within the gas delivery system and entire breath ing circuit adjusts at the following rate Up to 18 seconds for deliver...

Страница 153: ...bed in this chapter Unpacking and inspection Unpack the ventilator and inspect it for damage Inspect the exterior cabinet of the ventilator for cracks scratches or blemishes Inspect the front panel for scratches or abrasions Correct and or report any problems found to Philips before using the ventilator Before using the ventilator the first time we recommend wiping the exterior clean and disinfect...

Страница 154: ...tilator to a stand make sure the stand is approved by Philips The ventilator may be mounted to the optional stand or placed on a flat stable clean surface Figure A 2 shows the installed ventilator Align the ventilator above the stand as shown in Figure A 1 Make sure the four feet at the base of the ventilator are aligned to slide into the grooves at the top of the stand Ensure that the locking lev...

Страница 155: ...e installed ventilator Use the brakes to lock and unlock the wheels as needed Make sure the wheels are unlocked before moving the ventilator Figure A 2 Respironics V60 V60 Plus Ventilator on stand Power cords can be stored on stand hooks Wheel lock ...

Страница 156: ...Respironics V60 V60 Plus Ventilator only Install the battery as follows Figure A 3 1 Shut down and then unplug the ventilator NOTE Failure to properly shut down the ventilator before battery installation may result in erroneous alarms after power on 2 Remove the side panel by turning the captive fastener a turn and releasing 3 Using a 3 mm hex wrench remove the battery bracket by removing two scre...

Страница 157: ...alarm occurs when verifying ventilator operation discontinue use of the ventilator immediately and contact Philips The Vent Inoperative alarm occurs if AC power is disconnected and a battery is not installed or if the battery is fully discharged NOTE A new battery must be charged for at least 5 hours before being placed into service Based on the age and state of the battery it may take up to 16 ho...

Страница 158: ...A 6 First time installation Figure A 3 Installing the battery Captive fastener Bracket Battery cable Battery Orient with vent hole on top and Philips logo facing out ...

Страница 159: ...to other countries may require installation of the power cord and oxygen inlet connector 1 Install the oxygen inlet connector as follows Figure A 4 a Gently fit connector into the hole provided with flat sides to the left and right b Install the oxygen inlet connector retaining plate Tighten the two screws with a 2 5 mm hex wrench Figure A 4 Installing the oxygen inlet connector Retaining plate Ox...

Страница 160: ...ioned in a way that makes it difficult to disconnect from mains power if necessary Disconnect from supply mains by removing the power cord from the wall outlet The AC mains plug is used as disconnection device 2 Secure the power cord with the power cord retainer Figure A 5 a Remove the power cord retainer by removing two screws b Connect the power cord that is appropriate to your region into the A...

Страница 161: ... 3 Disconnect the proximal pressure airway pressure line from the ventilator connector and verify that the Proximal Pressure Line Disconnect alarm is annunciated audio visual and flashing alarm LED 4 Reconnect the proximal pressure line and manually reset the alarm 5 Turn the ventilator off 6 Remove the patient circuit The ventilator is ready to be set up for use as described in Chapter 5 Configur...

Страница 162: ...A 10 First time installation ...

Страница 163: ...is not currently available for use DO NOT connect or attempt to power any equipment from the USB port WARNING It is the responsibility of the end user to validate the compatibility and use of information transmitted from the ventilator to the device to be connected to the ventilator WARNING The data provided through the communications interface is for reference only Decisions for patient care shou...

Страница 164: ...unications interface VRPT SNDA Developers Guide 1147828MC available at www philips com IFU Using Philips IntelliBridge or VueLink Using Philips monitors and the IntelliBridge or VueLink Open Interfaces NOTE Data displayed on the IntelliBridge or VueLink systems is for reference purposes only Decisions for patient care should not be based solely on the data obtained through the IntelliBridge system...

Страница 165: ... the documentation for your IntelliBridge or VueLink module and patient monitor Philips patient monitor IntelliBridge EC10 module PN 865115 A01 or VueLink module PN M1032 A02 IntelliBridge interface cable Part of EC5 module or VueLink interface cable PN M1032 61654 EC5 module PN 865114 Option 105 for EC10 only Table B 1 Ventilator data displayed on Philips monitor Monitor label Ventilator label Wa...

Страница 166: ...sRisTi Rise Rise Time sRmpTi Ramp Time sRppv Max R sRRaw Rate Respiratory Rate sTV VT AVAPS Target Tidal Volume sVmax Max V PPV Maximum Volume Limit sVMode Ventilation mode Alarm messages HIGH INSP PRESS High Inspiratory Pressure HIGH O2 SUPPLY High O2 Supply Pressure HIGH RESP RATE High Rate HIGH EXH TV High Tidal Volume LOW INSP PRESS Low Inspiratory Pressure LOW BATTERY Low Internal Battery LOW...

Страница 167: ...xample when the ventilator is in an isolation room The ventilator sends alarm signals to a remote alarm through the connector at the rear of the ventilator Figure B 1 on page B 1 Figure B 4 shows the pin assignments for this connector The connector is a standard inch female audio ring tip sleeve connector The ventilator signals an alarm using either a normally open NO or normally closed NC relay c...

Страница 168: ...ctor and cable Table B 2 Remote alarm cable kits Description System Part Number Remote alarm cable kit alarm state open Use on Normally Closed nurse call systems system expects to see open contacts when ventilator alarms For jack 1003741 Remote alarm cable kit alarm state closed Use on Normally Opened nurse call systems system expects to see closed contacts when ventilator alarms For jack 1003742 ...

Страница 169: ...n include but are not limited to HMEs proximal flow sensors a filter at the patient connection or a narrow diameter circuit attached to a mask NOTE To ensure the correct performance of the ventilator and the accuracy of patient data we recommend you use only Respironics approved accessories with the ventilator For the most current list of approved accessories plus comprehensive ordering informatio...

Страница 170: ... monitor Description Type Respironics Contour Deluxe Nasal Respironics AP111 Respironics PerformaTrak Oro nasal Respironics AF541 over the nose Respironics AF541 under the nose Respironics AF531 Respironics PerforMax adult only Total Description Respironics AC611 high flow nasal cannula Respironics AC611 high flow nasal cannula with filtered exhalation port FEP connector Description Part number Or...

Страница 171: ...e limb non heated filtered exhalation port FEP proximal pressure line single use 22 mm ID 10 1065830 with inspiratory and exhalation port filters 1065832 with inspi ratory port filter only 1069210 with no filters 989805621311 989805621321 989805634871 Patient circuit single limb non heated disposable exhalation port DEP proximal pressure line single use 22 mm ID 10 582073 989805609611 Patient circ...

Страница 172: ...e use 1 1002362 453561517101 Description Quantity Part number Order number Aerogen Solo nebulizer for inline applications Refer to the V60 ordering and accessories guide NIVO generator for mask elbow applications 5 1076302 989805634301 Description Quantity Part number Order number Cooling fan filter 5 1054280 453561507301 Air inlet filter 5 1054279 453561505991 Description Part number Order number...

Страница 173: ...igher immunity test levels than those specified in IEC 60601 1 2 2014 Table 9 are used the minimum separation distance may be lowered Lower minimum separation distances shall be calculated using the equation specified in chapter 8 10 of the standard WARNING Do not use the ventilator near radio frequency identification RFID or electromagnetic security systems The ventilator may disrupt the operatio...

Страница 174: ...pment or system for magnetic resonance imaging where the intensity of electromagnetic EM disturbances is high These devices may degrade the performance of the ventilator Electromagnetic emissions NOTE The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A Guidance and manufacturer s declaration electromagnetic emissions The V60 V...

Страница 175: ...ge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical hospital environ ment Voltage dips short interruptions and voltage variations on power supply in put lines IEC 61000 4 11 0 UT for 0 5 cycles 0 UT for 1 0 cycle 70 UT for 25 cycles 50 Hz 30 cycles 60 Hz 0 UT for 250 cycles 50 Hz 300 cycles 60 Hz 0 UT for ...

Страница 176: ...magnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 7 GHz...

Страница 177: ...0 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 7 GHz to decrease the likelihood that...

Страница 178: ...l equipment or system should operate safely when it experiences field strength E that is equal to or lower than its specified RF immunity In general the field strength falls off proportional to 1 d although care must be taken because some environments where large metallic objects such as HVAC ducts and cabinetry are present can cause reflections such that field strength in certain close in ranges ...

Страница 179: ... frequencies greater than or equal to 800 MHz In Edition 4 24 k is assumed to be 6 for all frequencies Cables That May Affect IEC 60601 1 2 Compliance Cables such as remote alarm cables longer than 3 05 m may affect the compliance of the ventilator system with the emissions and immunity requirements of IEC 60601 1 2 WEEE recycling directive Waste electrical and electronic equipment WEEE recycling ...

Страница 180: ...2013 Ed 3 1 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance collateral standard usabil ity IEC 60601 1 8 2012 Ed 2 1 Medical electrical equipment Part 1 8 General requirements for basic safety and essential requirements collateral standard alarm systems IEC 62366 1 2015 Ed 1 1 Medical devices Application of usability engineering to medical devi...

Страница 181: ...m includes these detachable components see Figure 3 4 and Figure 3 5 Left side panel Right side panel Air inlet filter under side panel Essential performance Per ISO EN 80601 2 12 2011 Medical electrical equipment Part 2 12 Particular requirements for basic safety and essential performance of critical care ventilators the ventilator s essential performance requirements are given in Control setting...

Страница 182: ...D 10 Regulatory compliance ...

Страница 183: ...ures Entering the diagnostic mode WARNING To prevent possible patient injury do not enter the diagnostic mode while a patient is connected to the ventilator Verify that the patient is disconnected before proceeding Enter the diagnostic mode as follows 1 Make sure the patient is disconnected and the ventilator is powered off 2 Press and hold the Accept button on the top right front of the ventilato...

Страница 184: ...E 2 Diagnostic mode 3 Within less than 5 seconds release and press the Accept button again The Diagnostics Menu Figure E 1 is displayed Figure E 1 Diagnostics Menu 4 Select the desired function ...

Страница 185: ...Diagnostic mode E 3 System settings From the System Settings screen Figure E 2 you can perform the functions below Figure E 2 System Settings screen ...

Страница 186: ...ic mode Language The Language function lets you set the language of software display 1 From the System Settings screen select Language to display the Set Language screen Figure E 3 Figure E 3 Set Language screen 1 ...

Страница 187: ...ge is shown in white type Select the new language 3 A second Set Language screen is displayed Figure E 4 Select Ventilator Shutdown to apply the change The change is effective after you restart the ventilator Figure E 4 Set Language screen 2 ...

Страница 188: ... function lets you verify date and time settings 1 From the System Settings screen select Date Time to display the Set Date and Time screen Figure E 5 Figure E 5 Set Date and Time screen 2 Adjust the date and time with the and buttons then Apply ...

Страница 189: ...r pressure display 1 From the System Settings screen select Pressure Units to display the Set Pressure Units screen Figure E 6 Figure E 6 Set Pressure Units screen 2 The active pressure unit is shown in white type Select the desired pressure unit The change is effective after you restart the ventilator ...

Страница 190: ...you return ventilator settings to factory defaults The factory defaults are listed in Chapter 11 1 From the System Settings screen select Restore Default Settings to display the Restore Default Settings screen Figure E 7 Figure E 7 Restore Default Settings screen 2 Select Restore Defaults ...

Страница 191: ... 6 18 If the serial numbers do not match contact Philips 1 From the System Settings screen select Software Options to display the Enable Software Options screen Figure E 8 Figure E 8 Enable Software Options screen 2 Use the onscreen keypad to enter the code then select Enter The screen displays Enabled followed by the name of the software option 3 Repeat as needed to enable additional options 4 Ve...

Страница 192: ...for serial communications 1 From the System Settings screen select Baud Rate to display the Set Baud Rate for Serial Communications screen Figure E 9 Figure E 9 Set Baud Rate for Serial Communications screen 2 The active baud rate is shown in white type Select the desired baud rate ...

Страница 193: ...he alarm volume to the user setting 1 From the System Settings screen select Alarm Volume Escalation to display the Set Alarm Volume Escalation screen Figure E 10 Figure E 10 Set Alarm Volume Escalation 2 The current setting is shown in the Information box at the top of the screen If Alarm Volume Escalation is currently Disabled you will see a selectable Enable button If Alarm Volume Escalation is...

Страница 194: ...Significant Event Log The Significant Event Log contains data about clinically relevant ventilator occurrences including alarms and setting changes The time date and an identifier for event classification are included A maximum of 2 000 event records are retained The oldest events are overwritten first to allow recording of new events 1 From the Service screen select the Misc tab 2 The Miscellaneo...

Страница 195: ...Diagnostic mode E 13 3 The Significant Event Log opens Figure E 12 Use the buttons on right side to navigate through the log Figure E 12 Significant Event Log screen ...

Страница 196: ... Screen Calibration The Touch Screen Calibration screen is displayed Figure E 13 NOTE If the Touch Screen Calibration button does not respond press the Accept button on the top right front of the ventilator to begin Figure E 13 Calibrate Touch Screen screen 2 Follow the steps shown Press on the middle of each target with a blunt narrow object ...

Страница 197: ...hen prompted touch the screen to exit calibration If the calibration is not successful have the ventilator serviced Exiting the diagnostic mode Exit the diagnostic mode by turning off ventilator power with the ON Shutdown key ...

Страница 198: ...E 16 Diagnostic mode ...

Страница 199: ...de enhanced sensitivity in the presence of leaks and changing breathing patterns AVAPS Average volume assured pressure support A ventilation mode in which pressure support is automatically adjusted to maintain the user defined target tidal volume AVAPS Maximum IPAP Pressure See Max P AVAPS Minimum IPAP Pressure See Min P AVAPS Target Tidal Volume See VT Average volume assured pressure support See ...

Страница 200: ... the reciprocal of compliance EPAP Expiratory positive airway pressure A control setting The application and maintenance of pressure above atmospheric at the airway throughout the exhalation phase of positive pressure mechanical ventilation Estimated exhaled tidal volume See VT Estimated minute ventilation See E Estimated patient leak See Pt Leak Estimated total leak See Tot Leak ET Endotracheal E...

Страница 201: ...c at the airway throughout the inspiration phase of positive pressure mechanical ventilation ISO International Organization for Standardization a worldwide federation of national standards bodies I Time Inspiratory time The duration of inspiration during mechanical ventilation L Liter LCD Liquid crystal display LED Light emitting diode Limit To prevent from exceeding a specified maximum value duri...

Страница 202: ...ventilation mode that provides mandatory and spontaneous breaths with a set frequency pressure and inspiratory time Peak inspiratory pressure See PIP Percentage of patient triggered breaths See Pt Trig PIP Peak inspiratory pressure The peak pressure for the previous inspiration PPV A control setting in PPV The percent of proportional pressure ventilation supplied by the ventilator PPV proportional...

Страница 203: ...ircuit tubing for a unit of flow when the volume of the device remains constant i e cmH2O mL sec Respiratory Rate Rate Respiratory frequency a control setting Rise Time Rise The time required for a pressure supported or pressure controlled breath to reach its target pressure a control setting RS 232 Serial data communications protocol SIS Sleeve Indexed System Australia A connector for high pressu...

Страница 204: ...ed parameter shown when the mask leak and type of exhalation port are not known Trigger To begin inspiration Trigger Trigger Sensitivity a control setting in Auto Trak Trigger Sensitivity See Trigger Unintentional leakage Unpredictable leakage that cannot be quantified V Volt a unit of electrical potential or volume Flow E Estimated minute ventilation The product of tidal volume spontaneous and ti...

Страница 205: ...Average volume assured pressure support mode See AVAPS mode B Backup alarm 3 10 Backup battery See Battery backup Bacteria filter must be installed onto gas outlet message 9 7 Baseline pressure description 4 2 Batch settings how to make 6 3 6 19 Battery backup description 3 10 3 11 how to install A 4 A 6 location 3 9 operation time 3 10 part number C 4 specifications 11 8 Baud rate for ventilator ...

Страница 206: ...tive airway pressure setting defini tion 6 23 D Date and time how to change E 6 Default factory settings how to restore E 8 Definitions F 1 F 6 Delivered pressure specifications 11 10 Diagnostic mode E 1 E 15 how to calibrate touchscreen E 14 E 15 how to change baud rate E 10 how to change date and time E 6 how to change language E 4 E 5 how to change pressure unit E 7 how to enable or disable Ala...

Страница 207: ... 6 27 Lo VT Low Tidal Volume Alarm setting definition 6 26 Locking and unlocking the screen 6 18 Log event how to view E 12 E 13 Loudness how to set alarm 6 17 Low Inspiratory Pressure alarm 9 8 Low Inspiratory Pressure Alarm setting See LIP Low Inspiratory Pressure Delay Time setting See LIP T Low Internal Battery alarm 9 8 Low Leak CO2 Rebreathing Risk alarm 9 8 Low Minute Ventilation alarm 9 9 ...

Страница 208: ...herapy HFT 1 7 7 1 operation 1 7 packing and shipping 10 9 preparing for ventilation 1 4 1 7 preventive maintenance 10 4 remote alarm B 5 Preparing for ventilation 5 1 5 13 Pressure Regulation High alarm 9 11 Pressure unit how to change E 7 Pressure baseline description 4 2 Pressure controlled ventilation mode See PCV Preventive maintenance 10 4 10 8 schedule 10 5 Principles of operation 4 1 4 15 ...

Страница 209: ... Supply Failed alarm 9 16 Vent Inoperative 1002 Blower Temperature Too High alarm 9 16 Vent Inoperative 1003 Internal Temperature High alarm 9 16 Vent Inoperative 1004 Internal Temperature High alarm 9 16 Vent Inoperative 1005 Internal Temperature High alarm 9 17 Vent Inoperative 1006 Data Acquisition PCBA ADC Failed alarm 9 17 Vent Inoperative 1007 Machine and Proximal Pressure Sen sors Failed al...

Страница 210: ...Index Index 6 ...

Страница 211: ......

Страница 212: ...d the most current electronic copy of this user manual at www philips com IFU This manual documents software versions 2 30 3 00 and 3 10 All rights are reserved Reproduction or transmission in whole or in part in any form or by any means electronic mechanical or otherwise is prohibited without the prior written consent of the copyright owner 2009 2021 Koninklijke Philips N V Printed in USA 1047358...

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