Philips 1146562 User Manual Download

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1146562 R00

KGP 04/10/2020

EN-INTL

User manual

E30

Ventilation solution

REF

1146562

Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA

Respironics Deutschland GmbH & Co. KG
Gewerbestrasse 17
82211 Herrsching, Germany

Summary of Contents for 1146562

Page 1: ... KGP 04 10 2020 EN INTL User manual E30 Ventilation solution REF 1146562 Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA Respironics Deutschland GmbH Co KG Gewerbestrasse 17 82211 Herrsching Germany ...

Page 3: ...ings Device usage The Philips Respironics E30 ventilator is a multi patient use device but should only be used on a single patient at any given time Patient monitoring Prior to placing a patient on the ventilator a clinical assessment should be performed to determine The device alarm settings Needed alternative ventilation equipment If an alternative monitor i e an alarming Pulse Oximeter or Respi...

Page 4: ...ould be plugged into the facility s emergency backup power outlet orange outlet or a UPS should be used to provide battery back up in the event of loss of AC mains power Alarm indicators The high priority and medium priority alarms have the same auditory indication These two alarm priorities are differentiated by visual indications Red signals a high priority alarm and yellow signals a medium prio...

Page 5: ... UPS 18 3 5 Connecting the breathing circuit 19 3 6 Installing the O2 inlet port 19 3 7 Starting the device 19 3 8 Navigating the device screens 20 3 9 Menu navigation with therapy on and optional humidification settings 20 3 10 Provider mode with therapy off 22 3 11 Patient mode with therapy off 26 3 12 Altitude compensation 28 4 Alarms alerts and troubleshooting 29 4 1 Device alarms 29 4 2 Devic...

Page 6: ...ygen 44 5 6 SD card 44 6 Cleaning 45 6 1 Cleaning and replacing the device filters 45 6 2 Hospital and institution cleaning device and O2 inlet port exterior 45 6 3 Hospital and institution disinfection device and O2 inlet port exterior 46 6 4 Service 47 7 Specifications end of use and EMC 49 7 1 Specifications 49 7 2 End of use 51 7 3 Disposal 51 7 4 EMC information 52 Limited warranty 55 ...

Page 7: ...er cord Power cord cable clamp and screw Power supply O2 inlet port External alarm module kit or uninterruptible power supply UPS 1 2 Intended use The Philips Respironics E30 ventilator is intended to provide invasive and non invasive ventilatory support for individuals with Respiratory Insufficiency It is specifically for the care of adult and pediatric patients 7 years of age and 18kgs It is int...

Page 8: ...ould be prepared to providealternate therapy in the event of ventilator failure or inoperative equipment Personnel qualifications This manual serves as a reference The instructions in this manual are not intended to supersede your health care professional s instructions regarding the use of the device The prescription and other device settings should only be changed on the order of the supervising...

Page 9: ...e is turned on and operating properly The circuit s exhalation device should never be blocked Explanation of warning The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the exhalation device Howev...

Page 10: ...tering fixed flow supplemental oxygen the oxygen concentration may not be constant The inspired oxygen concentration will vary depending on the pressures patient flows and circuit leak Substantial leaks may reduce the inspired oxygen concentration to less than the expected value Appropriate patient monitoring should be used as medically indicated such as an alarming pulse oximeter When using oxyge...

Page 11: ...not working properly Replace damaged parts before continuing use Periodically inspect electrical cords cables tubing and accessories for damage or signs of wear Discontinue use and replace if damaged Cleaning To avoid electrical shock always unplug the power cord from the wall outlet and or external power supply module before cleaning the device Do not immerse the device in any fluids or spray the...

Page 12: ...the device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Do not operate the device outside of the operating temperature range shown in the Specifications chapter later in this manual Device Filters If not using the O2 inlet port a properly installed undamaged Philips Respironics blue pollen filter ...

Page 13: ...here the risk from allergic reaction outweighs the benefit of ventilatory assistance Epistaxis causing pulmonary aspiration of blood Hypotension When assessing the relative risks and benefits of using this equipment the health care professional should understand that this device can deliver the pressure ranges indicated in the Control Accuracy table in Chapter 7 In the event of certain fault condi...

Page 14: ...r Class II equipment For airline use Complies with RTCA DO 160G section 21 category M Not applicable to Philips Respironics E30 Separate collection for electrical and electronic equipment per EC Directive 2012 19 EU Bluetooth symbol Indicates the device has Bluetooth capabilities Not applicable to Philips Respironics E30 Non ionizing electromagnetic radiation Indicates that the equipment includes ...

Page 15: ...midity limitation Indicates the range of humidity to which the medical device can be safely exposed Temperature limit Indicates the storage temperature limits to which the medical device can be safely exposed Packaging unit To indicate the number of pieces in the package Manufacturer Indicates the medical device manufacturer CC Date of Manufacture To indicate the date on which a product was manufa...

Page 16: ...uring therapy Not applicable to Philips Respironics E30 4 Door SD card filter access This door lifts open for access to the SD card and filter area 5 LCD display screen This is the User Interface for the therapy device 6 Control dial Turn the dial to scroll between options on the screen Press the dial to choose an option and silence and acknowledge alarms 7 Door accessory access This door lifts op...

Page 17: ...ning the device or accessories please contact Philips Respironics To contact Philips Respironics directly call 1 724 387 4000 or go to www respironics com to find your local customer service contact information You can also use the following address 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 1 724 387 4000 Deutschland Gewerbestrasse 17 82211 Herrsching Germany 49 8152 93060 ...

Page 18: ...12 Introduction Philips Respironics E30 User Manual ...

Page 19: ... and EPAP settings PS IPAP EPAP S T Spontaneous Timed Pressure Support A therapy mode where each breath is patient triggered and patient cycled or machine triggered and machine cycled S T mode is similar to S mode except that the device also will enforce a set minimum breath rate by if necessary providing machine time triggered breaths For these breaths the inspiratory time is also a set value PC ...

Page 20: ...14 Therapy modes Philips Respironics E30 User Manual ...

Page 21: ...r screens out pollens while the light blue ultra fine filter provides more complete filtration of very fine particles The reusable blue filter must be in place at all times when the device is operating The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles The reusable blue filter is supplied with the device A disposable light blue ultra fine fi...

Page 22: ...he device on a firm flat surface within easy reach at a level lower than the patient s sleeping position Or attach to the DreamStation Roll Stand per the accompanying instructions Make sure the device is away from any heating or cooling equipment e g forced air vents radiators air conditioners Cautions Make sure the filter area on the side of the device is not blocked by bedding curtains or other ...

Page 23: ...dule the device should be plugged into the facility s emergency backup power outlet orange outlet or a UPS should be used to provide battery back up in the event of loss of AC mains power Note There is an accessory clip that can be used to secure the power cord and the external alarm module or UPS to prevent accidental disconnection Route the cord through the clip and secure the clip to the enclos...

Page 24: ...pter 4 Note The UPS is not intended to be used to power your E30 ventilator but for backup power purposes in the event of an unexpected loss of power The UPS must be placed at least 2 m 6 5 ft away from the Philips Respironics E30 ventilator and patient Be certain to plug the UPS power cord directly into a wall outlet and not into a surge protector The UPS outlets are powered whenever the UPS is s...

Page 25: ... may prompt you to set the time on the device The default setting is Greenwich Mean Time but you may adjust the time in 30 minute increments to match your local time zone If you choose to skip this initial time setting the time can always be adjusted under the My Setup menu Note This time setting is not displayed as a clock function on the device It is only used to align a patient s therapy data w...

Page 26: ...t setting 3 Rotate the control dial to change the setting The rotate dial icon on any screen indicates to rotate the dial to perform an action 4 Press the control dial again to save the setting change The click dial icon on any screen indicates to press the dial to perform an action Notes Pressing the dial when the down arrow appears on any screen will take you to a sub menu with more menu options...

Page 27: ... following therapy features will display here Humidifier I or E indicates IPAP or EPAP state Patient breath indication Provider Mode Unlocked When Provider mode is unlocked pressing the Therapy on off button when the Therapy screen is displayed will show the monitoring screen below with displayed parameters Therapy PC Leak 10 0 30 7 440 16 95 0 RR SpO2 Vt cmH2O MinVent Pressure Setting Circuit Lea...

Page 28: ...ovider mode to allow for modification of device settings You can choose between the following Provider mode screens in addition to My Provider and My Setup not shown below If locked Provider mode can be accessed by following these steps 1 Supply power to the device if not already 2 Once the device is powered press and hold both the control dial and the Ramp button on the device for at least 5 seco...

Page 29: ...ough 30 BPM Ti Ti Allows you to modify the Inspiratory Time setting You may adjust the setting from 0 5 to 3 0 seconds in 0 1 increments Only displays in PC mode and if BPM is not set to Off in S T mode Alarm settings Choosing this screen will take you to a sub menu where you can enable or disable the alarms described below Icon Text Description Patient Disconnect Alarm You can enable or disable t...

Page 30: ...ient conditions in the room and is designed to not allow condensation to occur in the tube Humidifier This setting allows you to choose the desired humidity setting for the humidifier 0 1 2 3 4 or 5 Tube Type This setting allows you to select the correct size diameter tubing that you are using with the device You can choose either 22 for the 22 mm tubing or 15 for the 15 mm tubing Tube Type Lock T...

Page 31: ...onfirm the reset Press the control dial again to reset data in the device Note Reset Data resets blower hours that are visible to the patient but it does not reset machine hours in the Provider Menu Reset Blower Hours Select Yes if you want to reset the blower hours e g to track device usage between patients Reset Therapy Hours Select Yes if you want to reset the therapy hours back to the default ...

Page 32: ...card error is detected the Change Rejected icon appears Remove the SD card and reinsert If the alert continues to occur contact Philips Respironics at 1 800 345 6443 for a new SD card Clearing patient data for multiple users To clear patient data from the device use the Reset Data option available through the Device menu See Device settings earlier in this document for more information 3 11 Patien...

Page 33: ...an 4 hours and a yellow bar indicates less than 4 hours of use 3 11 2 My Provider When you select My Provider you will be able to view the following screens You cannot change settings in the Provider menu These screens are only for reference Icon Text Description Therapy This screen displays your therapy settings Settings cannot be adjusted from this screen Alarms This screen displays your alarm s...

Page 34: ...ws you to select the correct size diameter tubing that you are using with the device You can choose either 22 for the 22 mm tubing or 15 for the 15 mm tubing Note Tubing is identified on the cuff with the tubing identifier symbol 15 or 22 Note If a lock icon is displayed on this screen it indicates that your provider has locked this setting and you cannot change it Language This feature allows you...

Page 35: ...attention but are not alarm conditions Most alerts do not appear while therapy is being delivered The different types of alerts are Status Message appears on the screen Notification Message appears on the screen Alert Message appears on the screen and audible sound beeps once while alert is displayed 4 3 Alarm and alert audible indicators An audible indicator sounds when any of the following occur...

Page 36: ...ced Alerts When an alert appears on screen a brief 1 beep audible indicator sounds 4 3 1 Silencing an alarm You can temporarily silence an alarm by pressing the control dial The alarm is silenced for 60 seconds and then sounds again if the cause of the alarm has not been corrected If another alarm occurs while the silence period is active the audible alarm portion of the new alarm will not sound u...

Page 37: ...il alarm When connected to the device the external alarm module or UPS will provide an alarm when there is a power failure If this alarm is triggered on the external alarm module first ensure that power supply is plugged into outlet and that power failure alarm is connected to device and power supply If using an UPS ensure that it is connected and plugged in See instructions accompanying your acce...

Page 38: ...uit is disconnected or has a large leak Press the control dial to silence the alarm Press the control dial again to acknowledge and remove the alarm from the screen Reconnect the patient circuit or fix the leak If the alarm continues contact Philips Respironics or the product support team Technical alarms Device inoperative Shuts down Press the control dial to silence the alarm Disconnect the devi...

Page 39: ... contact Philips Respironics or the product support team High Operates This could be caused by an excessive leak blockage or a device malfunction Press the control dial to silence the alarm Press the control dial again to acknowledge and remove the alarm from the screen Remove your mask Check for the following dirty inlet filters blocked air intake excessive leak in the patient circuit If the alar...

Page 40: ...act Philips Respironics or the product support team Medium Operates Press the control dial again to acknowledge and remove the alarm from the screen Remove your mask Remove power from the device Confirm a compatible external alarm module or UPS is attached is attached Switch to compatible power supply if needed 4 8 Alert summary table The following table summarizes the alerts See Alarm and alert a...

Page 41: ...message Disconnect the device from power Immediately remove patient from ventilator and connect them to alternate source of ventilation Contact Philips Respironics or the product support team SD Card Removed Notification or Alert Indicates SD card has been removed from therapy device and not reinserted before the start of the current therapy session Reinsert SD card or press the control dial to cl...

Page 42: ...ly check that electrical contacts are clear then reconnect humidifier and power cord If alert continues contact Philips Respironics or the product support team The attached power supply does not support humidification Alert Indicates that the attached power supply is not capable of supporting humidification Contact Philips Respironics or the product support team to obtain a compatible Philips Resp...

Page 43: ...e the AC power cord is connected correctly to the power supply and the power supply cord is securely connected to the device s power inlet If the problem continues to occur contact Philips Respironics or the product support team Return both the device and power supply so they can determine if the problem is with the device or power supply The airflow does not turn on There may be a problem with th...

Page 44: ...pironics or the product support team I m having difficulty adjusting the heated humidifier setting The blower is not turned on or the humidifier is not fully connected The humidifier settings can only be adjusted from the Therapy ON display screen Confirm that the blower is turned on and that the settings are visible on the right side of the screen then adjust to desired comfort If the blower is o...

Page 45: ... pour out the spilled water Once the heater plate has cooled wipe the inside of the humidifier with a paper towel or soft cloth If needed dry the underside of the humidifier and confirm that your table top is dry Reconnect the humidifier and power supply and reinstall the water chamber 4 10 System checkout procedure 4 10 1 Verifying the pressure Warning If the device fails to perform within the st...

Page 46: ...ssure setting does not match the measured value for the device contact Philips Respironics 10 Press the Therapy on off button The unit is ready for patient use 4 10 2 Verifying the alarms Use the test setup from the Verifying the Pressure instructions in Section 4 10 1 for the following tests Important The following steps assume that the steps in Section 4 10 1 have been run first When testing is ...

Page 47: ...o clear the alarm 9 Set the Apnea setting to Off and press the dial to accept the setting 10 Return to the Main Menu to exit Low Minute Ventilation Alarm Test 1 When in the Provider mode in Standby scroll between the options to the Therapy screen and set the mode to S T mode 2 Connect the device to an approved circuit Whisper Swivel II leak device and test lung Press the Therapy on off button 3 Ob...

Page 48: ...onics E30 User Manual Loss of Power Alarm Test 1 While the device is providing therapy unplug the power cord and verify that an alarm is triggered on the external alarm module or UPS 2 Reconnect power and verify that the device resumes providing therapy ...

Page 49: ...r Addendum to complete setup information 5 2 Link module The Link Module is able to receive oximetry data and transfer it to the therapy device For use in a laboratory setting the Link Module also includes an RS 232 or DB9 port to allow remote control of the device by a personal computer Warnings If you notice any unexplained changes in the performance of this device if it has been dropped or mish...

Page 50: ...se only Philips Respironics recommended SpO2 cables and pulse oximeter sensors Use of incompatible sensors can result in inaccurate pulse oximeter performance 5 4 DreamStation roll stand There is a roll stand available for use with your device Please see the instructions included with your roll stand for more information 5 5 Supplemental oxygen Oxygen may be added anywhere in the patient circuit u...

Page 51: ...en filter first detach the light blue ultra fine filter if applicable and set aside or dispose of as needed Then take the reusable filter to the sink turn it upside down and run warm tap water through the white filter media to rinse away any debris Next lightly shake the filter to remove as much water as possible Allow the filter to air dry completely before reinstalling it If the reusable blue po...

Page 52: ...tution cleaning and disinfection procedure listed in this guide is recommended by Respironics Use of other cleaning and disinfecting processes not specified by Respironics may affect the performance of the product Follow all instructions from the manufacturer of the disinfectant product Any deviation from these instructions the manufacturer s instructions or agents not listed in this guide may imp...

Page 53: ...dry completely before plugging in the power cord and re inserting the filter s 6 4 Service The device does not require routine servicing or preventative maintenance other than inspection for normal wear or damage and device cleaning Warning If you notice any unexplained changes in the performance of this device if it is making unusual or harsh sounds if it has been dropped or mishandled if water i...

Page 54: ...48 Cleaning Philips Respironics E30 User Manual ...

Page 55: ...terim Order for use in relation to COVID 19 and waiver of CE marking which authorize its use for the duration of the COVID 19 public health emergency unless terminated or revoked after which the products may no longer be used 7 1 4 Standards compliance This device is designed to conform to the following standards IEC 60601 1 General Requirements for Basic Safety and Essential Performance of Medica...

Page 56: ...2 O 2 5 cmH2 O Breath rate 0 to 30 BPM greater of 1 BPM or 10 of setting Inspiration time 0 5 to 3 seconds 10 of setting 0 1 second Pressure measured at the patient connection port with or without the integrated heated humidifer no patient flow 7 1 9 Pressure accuracy Pressure increments 4 0 to 30 0 cmH2 O in 0 5 cmH2 O increments Maximum static pressure accuracy according to ISO 80601 2 70 2015 P...

Page 57: ...Rate in Patient Circuit 0 lpm 10 lpm 20 lpm 25 lpm 30 lpm Adjusted for O2 Flow Rate mL Device Reading mL 200 300 400 500 600 700 800 900 1000 1100 200 400 600 800 1000 1200 1400 1600 7 2 End of use The Philips Respironics E30 Ventilator is provided globally for use under local emergency use authorizations such as the US Food and Drug Administration FDA Emergency Use Authorization EUA for ventilato...

Page 58: ...imetry data have been achieved the device indicates this to the user by displaying Oximetry Good Study If you suspect that your unit is affected by EMC interference remove power and relocate the device to another area If performance continues to be affected discontinue use and contact Philips Respironics Guidance and Manufacturer s Declaration Electromagnetic Emissions This device is intended for ...

Page 59: ...n UT for 0 5 cycle at 45 degree increments 70 UT 30 dip in UT for 0 5 seconds 5 UT 95 dip in UT for 5 seconds Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply Power frequency 50 60 Hz magnetic field IEC...

Page 60: ...54 Specifications Philips Respironics E30 User Manual ...

Page 61: ...ation of incidental or consequential damages so the above limitation or exclusion may not apply to you The Department of Health and Human Services Declaration Under the Public Readiness Act for Medical Countermeasures Against COVID 19 applies to the Philips Respironics E30 Ventilator in the United States This warranty is given in lieu of all other express warranties In addition any implied warrant...

Page 62: ...ty shall be limited at the option of Philips Respironics to the replacement or repair of the Product or the supply of an equivalent Product 5 To exercise your rights under this warranty contact your local authorised Philips Respironics dealer A list of all authorised dealers is available at the following link http www philips com au healthcare Alternatively you can make a claim under this warranty...

Page 63: ...Limited warranty 57 Philips Respironics E30 User Manual ...

Page 64: ...58 Limited warranty Philips Respironics E30 User Manual ...

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