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Hill-Rom Volara PVL1, User Manual

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Volara™ System, Model PVL1 User Manual (196286 REV C) 

 99

Specifications

C

LASSIFICATION AND 

S

TANDARDS

E

SSENTIAL 

P

ERFORMANCE

The essential performance of the Volara™ System, Model PVL1 is defined 
as: 

•

Therapy air pressure not to exceed 120 cmH2O.

Security Authentication/ 
Encryption

WPA/WPA2-Personal, WEP 64/128 bits

Classification

Standards

Safety Standards

ANSI/AAMI ES60601-1: 2005 + C1: 09 + 
A2: 10 + A1: 12
ANSI/AAMI HA60601-1-11:2015
CAN/CSA-C22.2 No. 60601-1: 14
CAN/CSA-C22.2 No. 60601-1-11:15
IEC 60601-1: 2005 + A1: 2012 
EN 60601-1: 2006 + A12:2014
IEC 60601-1:1988 + A1:1991 + A2:1995
IEC 60601-1-11: 2015-01 
EN 60601-1-11: 2015
IEC 60601-1-6: 2010 + A1:2013 
EN 60601-1-6: 2010 + A1:2015
IEC 62366-1: 2015-02
EN 62366-1: 2015

EMC Standards

FCC Part 15 Subpart B
EN 301 489-1 V 1.9.2:2011
EN 301 489-17 V 2.2.1:2011
IEC 60601-1-2: 2014 
EN 60601-1-2: 2015
RTCA DO-160G Section 21 

Radio Standards

FCC Part 15 Subpart C (2.4 GHz)
FCC Part 15 Subpart E (5.0 GHz)
ETSI EN 300 330 

Bio-compatibility

ISO 10993-1: 2009
ISO 18562-1: 2017 

Feature

Dimension

196654__C_2019-Apr-29_Cleaned

Summary of Contents for Volara PVL1

Page 1: ...Volara System Model PVL1 User Manual Product No PVL1 Rx only Federal USA law restricts this device to sale by or on the order of a physician 196654 REV C 196654__C_2019 Apr 29_Cleaned ...

Page 2: ...196654__C_2019 Apr 29_Cleaned ...

Page 3: ... written permission from Hill Rom Services Inc Hill Rom The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill Rom The information in this manual is subject to change without notice Hill Rom makes no commitment to update or keep current the information in this manual Hill Rom reserves the right to make changes without noti...

Page 4: ...lara is a trademark of Hill Rom Services PTE Ltd Replace this manual 196654 if it is damaged and or can not be read For product support or to order additional copies of this manual 196654 contact your distributor local Hill Rom representative or go to www hill rom com Reference Documents Maximus Volara and Synclara Airway Clearance Systems Service Manual 194922 196654__C_2019 Apr 29_Cleaned ...

Page 5: ... 8 Safety Instructions 9 Features 13 Control Unit 13 Front 13 Back 14 Volara Single Patient Use Circuit 15 Assemble and Connect the Patient Circuit 16 Connect the Volara Patient Circuit 17 Connect the Volara Patient Circuit for In line Ventilation Therapy 20 Assemble the Nebulizer Kit and Add Medication 22 Set up and Power on the Control Unit 24 Power off the Control Unit and Store the System 25 V...

Page 6: ...tness 46 Adjust Date and Time settings 47 Change the System Language 47 Enable or Disable Clinical Access 48 Set the Pressure Ceiling Limit 49 Connect a Barcode Reader or Pulse Oximeter 51 Connect to a WIFI Network 52 Connect to a Local WIFI Network 52 Connect to a Public Network 54 Connect to an Enterprise Network 55 Configure Network Settings 56 Test the Connection to VisiView Health portal 58 T...

Page 7: ...ng 79 Clean the Control Unit and Stand with Cart 80 Clean the Pulse Oximeter 81 Clean the Single Patient Use Circuit 81 Disinfect 84 Maintenance 85 Inlet Filter 85 Nebulizer Filter 86 Fuse 86 Expected Life 87 Service calls 87 Troubleshooting 88 Control Unit Does Not Power On 88 On screen Help 88 Information Indicators 89 Audio Alerts 89 Notification Messages 89 Warning Messages 90 Caution Messages...

Page 8: ...Use 97 Environmental Conditions for Transport and Storage 97 System Cool Down 98 Wireless Communication 98 Classification and Standards 99 Essential Performance 99 Federal Communications Commission FCC Compliance Statement 100 Electromagnetic Compatibility Guidance 102 Electromagnetic Immunity to Wireless Communications 106 196654__C_2019 Apr 29_Cleaned ...

Page 9: ...ons for setup use and maintenance of the Volara System Model PVL1 Before you operate the system make sure you have read and understand in detail the contents of this manual It is important that you read and strictly obey the safety aspects contained in this manual NOTE To identify the revision of your system see the serial number label on the back of the control unit IMPORTANT INFORMATION This sec...

Page 10: ...ways With both therapy the system can also deliver aerosolized medications and supplemental oxygen The nebulizer kit of the Volara patient circuit is designed to aerosolize medication approved for nebulization and prescribed by a physician INDICATIONS FOR USE The Volara System is indicated for but is not limited to patients with these conditions Difficulty in clearance of secretions Pulmonary atel...

Page 11: ...istory of pneumothorax Pulmonary air leak Recent pneumonectomy Pulmonary hemorrhage Myocardial infarction Vomiting POSSIBLE ADVERSE CONDITIONS When using the Volara System patients may experience one or more of these effects Hyperventilation Gastric distension Decreased cardiac output Increased intracranial pressure Increased air trapping Hyperoxygenation Pneumothorax Pulmonary air leak Pulmonary ...

Page 12: ...ions or actions that may have an effect on patient safety A WARNING identifies situations or actions that may have an effect on patient or user safety To ignore a warning could cause patient or user injury A CAUTION identifies special procedures or precautions that persons must obey to help prevent equipment damage PRODUCT SYMBOLS The following symbols may or may not be used on your Volara System ...

Page 13: ...th an F type applied part according to EN 60601 1 Class II equipment double insulated according to EN60601 1 Manufacturer or distributor complies with the Waste Electric and Electronic Equipment Directive 2002 96 EC Manufacture date Manufacturer Serial number Identifies a replaceable fuse link in an electronic circuit Catalog number Non sterile Symbol Definition 196654__C_2019 Apr 29_Cleaned ...

Page 14: ...of the medical equipment Mass of the medical equipment including the mass of the control unit accessories patient circuits and the pole clamp assembly Warning Read the User Manual for safety information for the battery Physician prescription required This system is certified for use on aircrafts Complies with RTCA DO 160G Section 21 Category M Nebulizer port USB port Power On Off control Symbol De...

Page 15: ...powered by the battery The system is connected to a WiFi network The system is transmitting data to the connected WiFi network The system is connected to a cellular network A Bluetooth device is connected to the system A USB drive is connected to the system Clinical Access is enabled The user is able to access all features on the system Clinical Access is disabled Some features are not available t...

Page 16: ...the cough flow Tidal volume delivered to the patient during the therapy Acronym Meaning CHFO Continuous High Frequency Oscillation CPEP Continuous Positive Expiratory Pressure HPP Highest Programed Pressure PC Pressure Ceiling PCF Peak Cough Flow SpO2 Blood Oxygen Saturation Vt Tidal Volume Symbol Description 196654__C_2019 Apr 29_Cleaned ...

Page 17: ...rning We recommend your first use of this product be in a supervised setting such as a doctor s office or at home with a clinical trainer Warning This system should only be used by trained persons Warning Use this product only for its intended use as described in this manual Do not use attachments not recommended by the manufacturer Warning Do not operate this system if it shows any signs of physi...

Page 18: ...e control unit Warning Do not use the system near flammable chemicals or products including flammable anesthetics Warning Keep the hoses tubings and power cord away from toddlers and children to avoid strangulation Warning Keep the small parts provided with this product away from children to avoid swallowing and causing a choking effect Warning Do not connect any equipment or accessories to the US...

Page 19: ... the supplied nebulizer kit in the patient circuit Warning Do not use this system without a bio filter Warning Do not use the system in a dusty environment Warning This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm Warning The Volara System is MR Unsafe Do not expose the system to any magnetic resonance MR environment NOTES...

Page 20: ...product Caution Use the Volara System only with the Hill Rom approved pulse oximeter 196694 The data from the pulse oximeter is for information purposes only Caution Use the Volara System only with the Hill Rom approved replaceable battery 194566S Caution Do not open crush puncture or incinerate the battery Do not immerse the replaceable battery in water or heat it over 140 F 60 C NOTE Caution If ...

Page 21: ...er Manual 196286 REV C 13 Features FEATURES CONTROL UNIT Front Item Description Item Description A Control unit D Therapy port B Touchscreen E Nebulizer port C Power On Off button F Therapy port cap 196654__C_2019 Apr 29_Cleaned ...

Page 22: ...em Description Item Description F Patient circuit hook K USB port G Handle L Foot switch port Not applicable on Volara Systems H Replaceable battery optional M Fuse holder I Ventilation fan N Air inlet filter J Power inlet O Nebulizer filter 196654__C_2019 Apr 29_Cleaned ...

Page 23: ...l B Breathing hose I Mouthpiece C Handset J Clear spontaneous breathing adapter optional D Adapter 22 mm x 22 mm K Oxygen bleed in adapter optional E Nebulizer kit L Blue ventilator adapter optional F Nebulizer tubing M Handset plug optional G Flexible tracheostomy adapter optional N In line ventilator adapter 22 mm x 15 mm optional 196654__C_2019 Apr 29_Cleaned ...

Page 24: ...otocols Warning Do not attempt to sterilize the circuit for reuse NOTES Each patient circuit is for use by a single patient and intended for 30 days of treatment or a maximum of 90 treatment sessions If the circuit and or bio filter are damaged or visibly soiled replace them See Replacement Parts Kits on page 78 The system keeps a log of the number of use cycles for the patient circuit If a patien...

Page 25: ...h one end of the breathing hose A to the smaller end of the bio filter B 2 Align the larger end of the bio filter C with the therapy port on the control unit 3 Gently turn the bio filter C to secure it to the therapy port NOTE Make sure the frosted part of the bio filter covers the therapy port entirely 4 Connect the other end of the breathing hose D to the inlet port of the handset E 5 Connect th...

Page 26: ...ut port of the clear spontaneous breathing adapter H Face mask L a Insert and gently twist the adapter M into the output port of the clear spontaneous breathing adapter H b Connect the other end of the adapter N to the face mask L Flexible tracheostomy adapter O a Insert and gently twist the adapter M into the output port of the clear spontaneous breathing adapter H b Connect the other end of the ...

Page 27: ...User Manual 196286 REV C 19 Assemble and Connect the Patient Circuit NOTE If the nebulizer kit is not used make sure the handset plug is installed tightly to cover the nebulizer port on the handset 196654__C_2019 Apr 29_Cleaned ...

Page 28: ... of the breathing hose A to the smaller end of the bio filter B 2 Align the larger end of the bio filter C with the therapy port on the control unit 3 Gently turn the bio filter C to secure it to the therapy port NOTE Make sure the frosted part of the bio filter covers the therapy port entirely 4 Connect the other end of the breathing hose D to the inlet port of the handset E NOTE If the clear spo...

Page 29: ... pressure oxygen source Warning The patient circuit is for single patient use only Always use a new patient circuit when using the system on a new patient Failure to do so could cause cross contamination CAUTION Caution When using oxygen with this system power on the system before you turn on the oxygen source Before you power down the system turn off the oxygen source This helps to prevent oxygen...

Page 30: ...ication out of the limits stated above NOTE A fill volume of 2 5 ml of medication is expected to last 10 minutes of nebulization 1 Remove the lid from the nebulizer cup 2 Fill the nebulizer cup with the prescribed medication 3 Replace the lid 4 Attach one end of the nebulizer tubing to the nebulizer port on the control unit 5 Attach the other end of the tubing to the base of the nebulizer cup 1966...

Page 31: ...ect the adapter 22 mm x 22 mm to the nebulizer port of the clear spontaneous breathing adapter or blue ventilator adapter 7 Connect the nebulizer kit to the adapter attached to the nebulizer port 8 The nebulizer kit is now connected to the patient circuit and control unit 196654__C_2019 Apr 29_Cleaned ...

Page 32: ...nt of 68 F 20 C for at least 80 minutes when removed from a storage temperature of 140 F 60 C or warmer If the control unit is on the cart make sure the casters are set For instructions on mounting the control unit on the cart see page 71 1 Set the control unit on a dry flat and hard surface Make sure the control unit is away from curtains blankets or any heat generating devices 2 Follow the steps...

Page 33: ...ers into sleep mode If the system is operating on battery it powers off NOTE If the system is in sleep mode and a battery is installed the system will charge the battery if it is not fully charged 2 Detach the patient circuit and accessories from the control unit 3 Clean the control unit patient circuit and accessories Follow the instructions in Cleaning and Disinfecting on page 79 or according to...

Page 34: ...ara System Model PVL1 User Manual 196286 REV C Volara Therapy VOLARA THERAPY ABOUT THE HOME MENU Item Description Item Description A Automatic Therapy mode B Manual Therapy mode 196654__C_2019 Apr 29_Cleaned ...

Page 35: ... view of a therapy summary C Care Plan Access the preset therapy settings D Device Settings Access the device control settings enable clinical access retrieve logs and configure connections to accessories available only if enabled E Help View on screen help information to guide you in using the system F Pull tab Access or exit the Options menu 196654__C_2019 Apr 29_Cleaned ...

Page 36: ...herapy put the patient interface into position on the patient Make sure the patient maintains a tight seal on the face mask or mouthpiece during the therapy Face mask Tightly but comfortably cover the mouth and nose of the patient Make sure the narrow end of the mask is over the patient s nose Mouthpiece Put the mouthpiece lightly in the patient s mouth Make sure that the patient maintains a tight...

Page 37: ...96286 REV C 29 Volara Therapy 4 Follow the steps that apply to the prescribed therapy mode Automatic mode see Volara Therapy in Automatic Mode on page 30 Manual mode see Volara Therapy in Manual Mode on page 34 196654__C_2019 Apr 29_Cleaned ...

Page 38: ...TOMATIC MODE Basic View in Automatic Mode Item Description Item Description A Name of the preset therapy selected D Heart rate and pulse oximeter readings available only if a pulse oximeter is connected B Digital manometer E Start stop control C Therapy status 196654__C_2019 Apr 29_Cleaned ...

Page 39: ...See Step 7 on page 18 1 Press Automatic If prompted scan the patient s ID barcode with the paired barcode reader For pairing instructions see page 51 The last used preset therapy is selected 2 To continue with this therapy press Start Or follow these steps to select another preset a Swipe the Options tab left and press the Care Plan menu control b Select the preferred preset therapy plan c Review ...

Page 40: ...herapy will stop and a warning message will show Follow the on screen instructions When the therapy is stopped or complete the therapy summary shows Note the number of treatment sessions carried out with the connected patient circuit 3 Press Back to go to the initial therapy screen Number of times the patient circuit has been used Maximum number of treatment sessions the patient circuit can be use...

Page 41: ... therapy swipe the Options tab left and select the Care Plan menu control 2 Select a preset therapy plan and press Options 3 Slide Cough Pause to ON 4 To modify the interval and duration of the cough pause therapy press the setting a Press the keypad control and enter the required setting or use or controls to adjust the setting b Press Save to save the changes Or press Cancel 5 When you have made...

Page 42: ...erapy swipe the Options tab left and select the Advanced View control The Advanced View shows 2 Press Start to begin the therapy Item Description Item Description A Digital manometer D Start stop control B Therapy status and control E CHFO frequency control C Heart rate and pulse oximeter readings available only if a pulse oximeter is connected 196654__C_2019 Apr 29_Cleaned ...

Page 43: ... reader For pairing instructions see page 51 The manual therapy screen shows the last used therapy settings 2 Use the or control to select the pressure settings Or use the keypad control to enter the required setting 3 Press Enter to confirm the setting NOTE The maximum pressure that can be set depends on the pressure ceiling limit defined in the Clinical Access settings See page 49 If required pr...

Page 44: ...s a Encourage the patient to exhale slowly 3 4 seconds b Encourage the patient to gently cough up secretions as they mobilize into the upper airways If required take extra care to appropriately suction secretions 6 When the therapy is complete press Stop The therapy summary shows NOTE Note the number of treatment sessions carried out with the connected patient circuit Number of times the patient c...

Page 45: ...he manual therapy screen 8 To go to the Home menu swipe the Options tab left and press the Home menu control NOTES The system does not allow a CPEP or CHFO stage to last for more than 30 minutes If the system is not used for more than 3 minutes a warning message shows 196654__C_2019 Apr 29_Cleaned ...

Page 46: ...ge 48 1 Press Automatic 2 Swipe the Options tab left and select the Care Plan menu control 3 Select an empty preset plan and press Create 4 Press Add to add a new stage after the current stage Or press Del to delete the current stage When a confirmation message shows select Proceed to continue or press Cancel NOTE Default pressure limits for each new stage are CPEP 25 cmH2O CHFO 70 cmH2O or the li...

Page 47: ... and or adjust the duration of use with a nebulizer 6 Press the setting to adjust the pressure setting 7 Use the or control to select the pressure settings Or use the keypad control to enter the required setting NOTE The maximum pressure that can be set depends on the pressure ceiling limit defined in the Clinical Access settings See page 49 8 Press Save to save the changes Or press Cancel If Coug...

Page 48: ...initial therapy screen shows NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 10 To start a therapy with the new Care Plan swipe the Options tab left and press the Care Plan menu control 11 Select the new Care Plan and press Start The therapy begins 1 Press Aut...

Page 49: ...ress the down arrow and select the option to modify CPEP Modifythetherapypressure therapy duration and enable or disable the use of a nebulizer CHFO Modify the therapy pressure therapy duration frequency of continuous high frequency pressure and enable or disable the use of a nebulizer NEB Enable or disable the therapy with the use of a nebulizer and or adjust the duration of use with a nebulizer ...

Page 50: ... Cancel If Cough Pause is enabled press Options a Press the setting to adjust the interval and duration of the cough pause b Press the keypad control and enter the required setting or use the or control to adjust the setting c Press Save to save the changes Or press Cancel 11 When you have completed the changes press Done The initial therapy screen shows NOTE To prevent unauthorized persons from a...

Page 51: ...rapy plan until the on screen keyboard shows 3 Use the on screen keyboard to enter any 5 alphanumeric characters for the new name 4 When complete press Enter when complete Or press Cancel The new name is saved NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 19...

Page 52: ...are Plan menu control 3 Select a preset therapy plan and review the therapy settings 4 Press Edit 5 When prompted press Delete The initial care plan screen shows and the selected preset therapy is removed NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 196654_...

Page 53: ...ly as determined by the patient s response to the therapy There is no need for CPEP as this therapy can be accomplished with the ventilator Procedures 1 Make sure that the system operates correctly 2 If possible the patient should be in a position such that the head of the bed is at an angle greater than 30 degrees 3 Assemble the patient circuit according to the instructions in Connect the Volara ...

Page 54: ...s screen shows You can view or adjust these settings Screen brightness Date and time 12 hour or 24 hour clock format Wireless connection WiFi Bluetooth Internet connection Logs and firmware upgrade 1 Press Device and press Controls 2 At Screen Brightness press and move the slider to adjust the brightness of the screen 3 When complete press the Home menu control to exit 196654__C_2019 Apr 29_Cleane...

Page 55: ... each item a To change the time zone press Modify b Scroll up or down to select the correct time zone and press Save 3 When complete press the Home menu control to exit 1 Press Device and press Language 2 Select the preferred language The languages available may differ depending on the country you are in 3 To confirm your selection press Save To cancel press Cancel 4 When complete press the Home m...

Page 56: ... Bluetooth devices such as a barcode reader or pulse oximeter Upgrade of the system firmware See the service manual for details NOTE Import of the Health Level 7 HL7 standard file 1 Press Device and press Controls 2 Slide the setting for Clinical Access to ON To disable slide the setting to OFF The user will not be able to access the manual modes or modify the preset therapy plans 3 Enter the key ...

Page 57: ...efined in the device settings WARNING Warning To avoid patient injury this setting should only be configured by facility authorized persons NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings 1 Press Control then slide Clinical Access to OFF 2 Press the Home menu control to exit NOTE Available only if Clinical Access is ena...

Page 58: ...system 2 Press the or controls to select the required PC setting NOTES Each press of the control increases decreases the PC setting by five 5 units The PC ranges between 5 70 cmH2O and is limited to the HPP gathered from the system The PC must be equal or greater than the HPP For example If HPP equals 45 cmH2O then PC must be equal to or greater than 45 cmH2O The user can not select a PC setting o...

Page 59: ...r Barcode Detection to ON 4 Press Connect 5 Slide the setting for Bluetooth to ON 6 Select SpO2 to add a pulse oximeter or Barcode to add a barcode reader To automatically detect and pair the Bluetooth device nearby press Scan A list of devices shows To manually add a device press Manual Setup a Use the on screen keyboard to enter the MAC address then press Enter to confirm the entry 7 When prompt...

Page 60: ...ting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 8 When complete press the Home menu control to exit 1 Swipe the Options tab left then press the Options menu control 2 Press the Device Settings menu control 3 Press Connect 4 Press WiFi 5 Slide the setting for WiFi to ON 6 Press Scan to locate the wireless n...

Page 61: ...rd to enter the Password 9 To confirm the entries press Proceed To cancel press Cancel 10 When the connection is successful a green check mark shows next to the access point name If the connection is unsuccessful an error message shows Press Return to go to the previous screens and make your entries again 11 To view the status of the connection press Status 12 When complete press the Home menu con...

Page 62: ...t to a public WiFi if any log on Terms and Conditions must be accepted to use that public WiFi 1 Swipe the Options tab left then press the Options menu control 2 Press the Device Settings menu control 3 Press Connect 4 Press WiFi 5 Slide the setting for WiFi to ON 6 Press Scan to locate the wireless networks available Depending on the networks available the scan will take a few minutes When comple...

Page 63: ...tatus of the connection press Status 9 Press the Home menu control to exit 1 Swipe the Options tab left then press the Options menu control 2 Press the Device Settings menu control 3 Press Connect 4 Press WiFi 5 Slide the setting for WiFi to ON 6 Press Scan to locate the wireless networks available Depending on the networks available the scan will take a few minutes When complete a list of wireles...

Page 64: ...e UserID and Password 9 To confirm press Proceed To cancel press Cancel 10 When the connection is successful a green check mark shows next to the access point name NOTE To enter specific server settings see page 56 If the connection is unsuccessful an error message shows Press Return to go to the previous screens and make your entries again 11 Press the Home menu control to exit 1 After the Volara...

Page 65: ...keypad 5 To test the entries made press Test Connections If the test is complete a confirmation screen shows If the test is unsuccessful try again later If the test continues to fail contact Hill Rom Press Return to exit the test connection screen 6 To connect to the server slide WiFi to OFF then ON again The network settings entered are submitted to the server 7 When complete press the Home menu ...

Page 66: ...he connection to VisiView portal before you start the therapy 1 After the Volara System is connected to a WiFi network press Settings 2 Slide the server option to Visiview 3 To test the connection press Test Connection 4 If the test is complete a confirmation screen shows If the test is unsuccessful try again later If the test continues to fail contact Hill Rom 5 Press the Home menu control to exi...

Page 67: ...ara System is connected to the WiFi network press Settings 2 Slide the server option to EMR 3 Press on each of the empty field and use the on screen keypad to enter the settings for Server IP Port Number NTP IP 4 After all entries are made press on the last entered yellow highlighted field to close the keypad 5 To test the entries made press Test Connections 6 If the test is complete a confirmatio...

Page 68: ... page 48 Retrieve the Therapy Logs 7 To confirm the settings entered slide WiFi to OFF then ON again 8 Press the Home menu control to exit 1 Swipe the Options tab left and press the Options menu control 2 Press the Device Settings menu control 3 Press Data NOTE Not all options are available at the same time 4 To view the Therapy Log press Review A list of therapy sessions shows 5 Select the date a...

Page 69: ... to go to the Data screen NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 10 Press the Home menu control to exit 1 Swipe the Options tab left and press the Options menu control 2 Press the Device Settings menu control 3 Press Data Not all options are available...

Page 70: ...nnect the USB drive to the port on the back of the control unit 8 At Error Log press Export Exporting begins When the export is complete a confirmation screen shows 9 Press Return to go to the Data menu NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 10 Press ...

Page 71: ...ss is enabled See page 48 1 Swipe the Options tab left and press the Options menu control 2 Press the Device Settings menu control 3 Press Data Not all options are available at the same time 4 Connect the USB drive to the USB port on the back of the control unit To export settings at Device Settings press Export When complete remove the USB drive To import settings a At Device Settings press Impor...

Page 72: ... NOTE To prevent unauthorized persons from adjusting the settings made disable Clinical Access after you have made the settings Press Device then press Control Slide Clinical Access to OFF 1 Swipe the Options tab left and press the Device Settings menu control The Device Information shows 196654__C_2019 Apr 29_Cleaned ...

Page 73: ... Item Part Number Replaceable Battery See page 66 194566S Pulse Oximeter Bluetooth See page 70 196694 WiFi Module USB 198658 Pole Clamp Assembly See page 71 M08235 Stand and Cart Assembly with Pole Clamp See page 71 M08177 Power Cord 3 m 10 181995 196654__C_2019 Apr 29_Cleaned ...

Page 74: ...harge Warning If the battery charge is below 20 you may not be able to complete your therapy session Warning If the battery is stored for a long period of time make sure to charge the battery at least once every 5 months CAUTION Obey these cautions to help prevent equipment damage Caution Do not open crush puncture incinerate immerse in water or heat over 140 F 60 C the battery Caution Use only th...

Page 75: ...stomer service Install the Battery NOTE These images show how to check that the battery is locked into position If you see an orange colored section in the latch area then the battery is not fully locked into position Press down on the battery until the orange colored section is no longer visible 1 Turn the patient circuit hook aside to get access to the battery compartment 2 Remove the battery co...

Page 76: ...tery symbol shows on the touchscreen Symbol Battery status The battery charge is low The battery is charging The battery is 25 charged The battery is 50 charged The battery is 75 charged The battery is fully charged The control unit has lost communication with the battery and is not powered by the battery 196654__C_2019 Apr 29_Cleaned ...

Page 77: ...nt damage NOTE The power cord supplied for your country may differ from the illustration shown 1 Plug the power cord into the back of the control unit 2 Plug the other end of the power cord into the applicable power outlet LED indicator Battery status Four green bars The battery is fully charged Blinking bars The battery charge is low Blinking bars when the control unit is connected to AC power Th...

Page 78: ...lse oximeter 196694 The pulse oximeter is connected to the Volara System by Bluetooth The pulse oximeter monitors the patient s blood oxygen level and heart rate pulse When the pulse oximeter is connected you can view the readings collected from the patient on the control unit touchscreen 196654__C_2019 Apr 29_Cleaned ...

Page 79: ...nstall the Stand 1 Lock the casters to prevent the stand base from moving Install the pole with cart into the stand base 2 Lay the stand base on its side 3 Install the screw and washer to secure the stand base to the pole 4 Turn the hex wrench clockwise to tighten the screw 196654__C_2019 Apr 29_Cleaned ...

Page 80: ...User Manual 196286 REV C Accessories 5 Install the top pole into the stand base Make sure the groove is aligned with its opening in the bottom pole 6 Use the hex wrench to tighten the pole connection 196654__C_2019 Apr 29_Cleaned ...

Page 81: ...anual 196286 REV C 73 Accessories Install the Tray and Pole Clamp 1 Note the guide on the back of the tray 2 Turn the tray over and attach the pole clamp to the tray with the supplied parts from the kit 196654__C_2019 Apr 29_Cleaned ...

Page 82: ...tion to install the tray 2 Turn the knob on the pole clamp clockwise to hold the tray in position on the cart 3 Put the control unit on the tray Make sure the screw holes on the bottom of the control unit are aligned with the screw holes on the tray 4 Attach the control unit to the tray with the supplied thumb screws 196654__C_2019 Apr 29_Cleaned ...

Page 83: ...ected to the oxygen source Caution Do not pull the control unit using the breathing hose or circuit tubing during transportation 1 Disconnect the oxygen hose from the facility connection and put the hose around the patient circuit hook 2 Unlock the locking casters 3 Move the stand to the applicable location 4 Lock the casters 5 Connect the oxygen hose to the facility connection 196654__C_2019 Apr ...

Page 84: ... is 25 by 10 mm Caution Make sure the safe working load of the mounting structure medical rail or IV pole system is able to support the weight of the control unit and pole clamp assembly See Product Specifications on page 96 1 Find the preferred position to mount the pole clamp assembly 2 Turn the knob on the pole clamp assembly clockwise to hold the tray in position 3 Put the control unit on the ...

Page 85: ...Volara System Model PVL1 User Manual 196286 REV C 77 Accessories 196654__C_2019 Apr 29_Cleaned ...

Page 86: ...D adult small 188341 Face mask 22 mm ID child 188340 Face mask 22 mm ID adult regular inflatable 183158 Foam air inlet filter 203923 Foam nebulizer filter 202909 Fuse 4 A 250 V 207914 Handset with clear spontaneous breathing adapter M08020 Mouthpiece 197068 Nebulizer kit 206705 Blue ventilator adapter with handset plug M07937 Oxygen bleed in adapter 206704 Patient circuit hook kit 203425S Stand as...

Page 87: ...vents or detergents Harmful cleaning solutions may cause skin rash and or irritation upon contact Warning Use cleaning and disinfectant products in accordance with the manufacturer s instructions Warning Fluid spills on to the unit electronics could cause a hazard If such a spill occurs unplug the unit and remove it from service When fluid spills occur outside of what is seen in normal use immedia...

Page 88: ...on Do not use bleach as your primary everyday cleaner disinfectant The system has been tested for compatibility with the following cleaning and disinfecting solutions Compatible cleaning and disinfecting solutions CLEAN THE CONTROL UNIT AND STAND WITH CART NOTES Clean the control unit and stand between therapy sessions when visibly soiled or according to facility protocols Do not spray the cleaner...

Page 89: ...IMETER CAUTION To help prevent equipment damage obey these cautions and cleaning instructions Caution Clean the pulse oximeter between patient to patient use or when visibly soiled Caution Avoid using any alcohol based solution to clean the display screen of the pulse oximeter This can damage the screen and cause clouding 1 Between patient use clean the finger probe area of the pulse oximeter with...

Page 90: ...isconnect the nebulizer tubing from the medicine cup b Remove the lid from the medication cup c Discard any unused medication in accordance with facility protocol 3 Disconnect the mouthpiece face mask adapters handset breathing hose and bio filter 4 Examine the inside of the bio filter for any damage and or soilage If there is soilage or damage replace the bio filter immediately For examples of da...

Page 91: ... next use of the system follow these instructions Examine the components of the circuit for cracks or other damage If there is damage replace the circuit See Replacement Parts Kits on page 78 For units with use of a nebulizer assemble the nebulizer first See page 22 196654__C_2019 Apr 29_Cleaned ...

Page 92: ... DISINFECT When there is visible soilage and also between patient use we recommend that you disinfect the unit with an EPA registered US only tuberculocidal disinfectant Dilute and use the disinfectant as shown on the manufacturer s label Soiled Filter Mucus or liquid is attached to the membrane Damaged Filter External casing of the filter has cracks or pieces missing Punctured Filter Membrane of ...

Page 93: ... Replace the inlet filter every twelve 12 months To clean the filter do as follows 1 Power off the control unit 2 Remove the inlet filter from the back of the control unit NOTE If the filter is damaged replace it See Replacement Parts Kits on page 78 3 Wash the filter with mild detergent and warm water and then rinse it with clean water 4 Allow the filter dry completely and then install it into th...

Page 94: ... follows 1 Power off the control unit 2 Remove the inlet filter from the back of the control unit NOTE If the filter is damaged replace it See Replacement Parts Kits on page 78 3 Wash the filter with mild detergent and warm water and then rinse it with clean water 4 Allow the filter to dry completely and then install it into the control unit FUSE If a fuse needs to be replaced do as follows 196654...

Page 95: ...WARNING Warning Only authorized persons should service the Volara System Service by unauthorized persons could cause personal injury or equipment damage If service is necessary use this contact information In the USA call a Hill Rom representative at 800 426 4224 Outside the USA contact your distributor or a local Hill Rom representative or go to www respiratorycare hill rom com NOTE When contacti...

Page 96: ... Make sure the power cord is fully plugged into an AC power Examine the fuse If necessary replace the fuse see page 86 If the problem continues contact a Hill Rom representative If the control unit is powered by a battery Make sure the battery is correctly installed in the control unit If necessary remove and install it See page 66 Press the battery indicator button next to the LED indicator on th...

Page 97: ...e next action required Follow the on screen instructions Alert Pattern Status One beep Indicates that an activity is successful Three beeps Indicates that attention is needed and you should look at the touchscreen Three beeps repeating every minute Indicates that attention is needed Read the Caution message shown on the touchscreen and follow the on screen instructions Three beeps followed by two ...

Page 98: ...er off the control unit then power it on again 009 1 Make sure only the Hill Rom approved battery 194566S is used 2 Press return after reading the on screen message 3 Make sure the battery is correctly installed in the control unit If necessary remove the battery and install it Remove the battery and install it See Install the Battery on page 67 010 1 Power off the control unit 2 Make sure the neb...

Page 99: ...ck of the control unit If necessary disconnect the power cord from the control unit and then connect it 2 Make sure the power cord is securely plugged into an AC power 3 Press return after you read the on screen message 014 1 Make sure the correct patient circuit is set up for the required therapy For details see Assemble and Connect the Patient Circuit on page 16 2 Press return after you read the...

Page 100: ...e 16 2 Make sure a tight seal is maintained on the face mask or mouthpiece 3 Examine the connections between the patient circuit components tubings and the control unit for any source of leakage If necessary disassemble the patient circuit and assemble it again If you see cracks on the patient circuit components replace the parts See Replacement Parts Kits on page 78 4 Press return after you read ...

Page 101: ...io filters near the control unit other than the one that is connected to the control unit 2 Press return after you read the on screen message 026 1 Replace the current bio filter with a new one See Replacement Parts Kits on page 78 2 Press return after you read the on screen message 029 1 Press return after you read the on screen message 2 Power off the control unit and leave the system to warm up...

Page 102: ...atient circuit components into a clean plastic bag 4 Pack the power cord replaceable battery patient circuit and other accessories into the compartments of the carry case 5 Close the carry case to secure the product inside 6 Store the system in a safe location within the recommended environmental conditions See Environmental Conditions for Transport and Storage on page 97 NOTE For long term storag...

Page 103: ...it in its original packing material When the system has reached the end of its useful life discard the system in accordance with local and federal standards SHIPPING FOR REPAIR When the control unit is shipped for repair follow these shipping and packaging instructions Request and get a return material authorization RMA number from Hill Rom You will get a return kit in the mail 1 Clean and disinfe...

Page 104: ...izer 5 cmH2O Per Stage Duration 1 sec to 5 minutes CHFO Frequencies Low medium and high Pressure Accuracy 5 cmH2O CHFO Frequency Accuracy 1 Hz Control Unit Depth 8 8 22 3 cm Width 9 2 23 3 cm Height 10 6 27 cm Weight 11 lb 5 kg Stand Optional Height to top of pole 39 4 100 cm Pole diameter Top pole 1 3 3 2 cm Pole diameter Bottom pole 1 5 3 9 cm Pole total length Base height 5 6 14 2 cm Base width...

Page 105: ...t CHFO pressure setting of 65 cmH2O and above Fuse rating Fuse 4 A H 250 V Feature Description Lithium ion Battery A new and fully charged battery can support 6 sessions of typical Volara therapy or 9 sessions of typical Synclara therapy Output 24 V DC 1 5 V DC Capacity 2700 mAh Condition Range Temperature 41 F to 95 F 5 C to 35 C ambient temperature Relative humidity 10 to 90 non condensing Press...

Page 106: ...nuously for 5 minutes at CHFO pressure setting of 65 cmH2O and above At least 20 minutes Feature Dimension Bluetooth Specification Optional Configuration Bluetooth compliance Bluetooth V4 0 BT Classic Frequency 2 40 to 2 48 GHz Transmit Power 8 dBm max 0 5 dBm Receive Sensitivity 90 dBm typical Modulation Frequency shift keying Frequency hopping spectrum WiFi Optional Configuration WLAN IEEE 802 1...

Page 107: ...15 CAN CSA C22 2 No 60601 1 14 CAN CSA C22 2 No 60601 1 11 15 IEC 60601 1 2005 A1 2012 EN 60601 1 2006 A12 2014 IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 1 11 2015 01 EN 60601 1 11 2015 IEC 60601 1 6 2010 A1 2013 EN 60601 1 6 2010 A1 2015 IEC 62366 1 2015 02 EN 62366 1 2015 EMC Standards FCC Part 15 Subpart B EN 301 489 1 V 1 9 2 2011 EN 301 489 17 V 2 2 1 2011 IEC 60601 1 2 2014 EN 60601 1 2 201...

Page 108: ... B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that in...

Page 109: ...86 REV C 101 Specifications To see the FCC ID of this system 1 Swipe the Options tab left and press the Device Settings menu control The device information screen shows 2 Find the FCC ID in the system information 196654__C_2019 Apr 29_Cleaned ...

Page 110: ...d result in improper operation Guidance and Manufacturer s Declaration Electromagnetic Emissions The Volara System Model PVL1 is intended for use in the electromagnetic environment specified below The customer or user of the Volara System Model PVL1 should make sure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Vo...

Page 111: ... s to line s 1 kV line s to line s Mains power quality should be that of a typical home environment 2 kV line s to earth Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT for 0 5 cycle at 00 450 900 1350 1800 2250 2700 and 3150 0 UT for 1 cycle 70 UT 25 30 cycles single phase at 00 0 UT for 250 300 cycles 0 UT for 0 5 cycle at 00...

Page 112: ...000 4 3 10 V m 80 MHz to 2 7 GHz 10 V m 80 MHz to 800 MHz 800 MHz to 2 7 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recom mended separation in meters m Field strengths from fixed RF transmitters as deter mined by an electromag netic site surveya should be less than the compliance level in each frequency range ...

Page 113: ...ference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to800 MHz 800 MHz to 2 7 GHz 0 01 W 0 12 m 0 04 m 0 07...

Page 114: ...Hz 0 3 Front back left right 710 9 V m 50 PM 217 Hz 0 3 Front back left right 745 9 V m 50 PM 217 Hz 0 3 Front back left right 780 9 V m 50 PM 217 Hz 0 3 Front back left right 810 28 V m 50 PM 18 Hz 0 3 Front back left right 870 28 V m 50 PM 18 Hz 0 3 Front back left right 930 28 V m 50 PM 18 Hz 0 3 Front back left right 1720 28 V m 50 PM 217 Hz 0 3 Front back left right 1845 28 V m 50 PM 217 Hz 0...

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