Hillrom Volara System Instructions for Use PDF

Volara System Instructions for Use Product No. PVL1 Hillrom is a part of Baxter Baxter PATENTS / PATENT hillrom.com/patents May be covered by one or more patents. See the Internet address above...

Volara System Instructions for Use Product No. PVL1 Hillrom is a part of Baxter Baxter PATENTS / PATENT hillrom.com/patents May be covered by one or more patents. See the Internet address above. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. FOSS This product may contain software known as “free” or “open source” software (FOSS). Hill-Rom uses and supports the use of FOSS. We believe that FOSS makes our products more robust and secure, and gives us and our customers greater flexibility. To learn more about FOSS that may be used in this product, please visit our FOSS website at hillrom.com/opensource. Where required, a copy of FOSS source code is available on our FOSS website. (For products that include a Heart and Respiration Rate monitoring system, please also visit earlysense.com/med-hrbedots to learn more about FOSS and third party software that may also be used in those products. Manufactured by: HILL-ROM SERVICES PRIVATE LIMITED 1 YISHUN AVENUE 7 SINGAPORE 768923 Authorized European Union Representative and Importer: WELCH ALLYN LIMITED NAVAN BUSINESS PARK DUBLIN ROAD NAVAN, COUNTY MEATH, C15 AW22 IRELAND No part of this text shall be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information or retrieval system without written permission from Hill-Rom Services PTE Ltd. (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. Volara System Instructions for Use (196654 REV 8) i Hill-Rom reserves the right to make changes without notice in design, specifications, and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products. Notice to Users and/or Patients in EU—Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. This manual (196654) was originally released and supplied in English. For a list of available translations, contact Hill-Rom Technical Support. Product images and labels are for illustrative purposes only. Actual product and label may vary. Eighth Edition, 2022-08 First Printing, 2019 Bluetooth is a registered trademark of Bluetooth SIG, Inc. Baxter, Cough Pause, Hillrom, Maximus, Smart-Filter, Synclara, and Volara are trademarks of Baxter International, Inc. or its subsidiaries. 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): In the USA, call Hill-Rom at 800-426-4224 Outside of the USA, contact your distributor, local Hill-Rom representative, or go to respiratorycare.hill-rom.com. Reference Documents Maximus, Volara, and Synclara Airway Clearance Systems Service Manual (194922) Volara System Single Patient Use Circuit Instruction Sheet (206703) Maximus, Volara, and Synclara Systems—Stand and Pole Clamp (M08177) Assembly Instructions (209109) Maximus, Volara, and Synclara—Systems Pole Clamp (M08235) Assembly Instructions (208011) ii Volara System Instructions for Use (196654 REV 8)  Table of Contents Indications for Use................................................ 1 Patient Population............................................ 1 Intended Users............................................... 1 Introduction...................................................... 1 Important Information............................................ 2 Theory of Operation.......................................... 2 Contraindications............................................ 3 Absolute Contraindications................................... 3 Relative Contraindications.................................... 3 Possible Adverse Conditions.................................. 3 Symbols and Acronyms........................................... 4 Document Symbols.......................................... 4 Product Symbols............................................. 4 Common Screen Symbols..................................... 8 Acronyms.................................................... 9 Safety Instructions............................................... 10 Features......................................................... 14 Control Unit................................................. 14 Front................................................... 14 Back.................................................... 15 Single Patient Use Circuit.................................... 16 Assemble and Connect the Patient Circuit........................ 17 Connect the Patient Circuit.................................. 18 Assemble the Nebulizer Kit and Add Medication......... 22 Using a Bacterial Filter In-line with the Volara System..... 23 Set Up and Power On the Control Unit............................ 24 Power Off the Control Unit and Store the System................. 26 Volara Therapy.................................................. 27 About the Home Menu...................................... 27 About the Options Menu.................................... 28 Start a Therapy.............................................. 29 Volara Therapy in Automatic Mode........................... 31 Basic View in Automatic Mode........................... 31 Start a Therapy in Automatic Mode...................... 32 Volara System Instructions for Use (196654 REV 8) iii Table of Contents Adjust In-Therapy Settings in Automatic Mode........... 34 Adjust the Cough Pause Settings........................ 36 Volara Therapy in Manual Mode............................. 37 Basic View in Manual Mode............................. 37 Start a Therapy in Manual Mode......................... 38 Volara Therapy with an In-line Ventilator..................... 41 Frequency of Use....................................... 41 Procedures............................................. 41 Advanced Volara Therapy Settings........................... 43 Create a New Preset Therapy Plan....................... 43 Modify a Preset Therapy Plan............................ 46 Rename a Preset Therapy Plan........................... 49 Delete a Preset Therapy Plan............................ 50 Device Settings.................................................. 51 Adjust the Screen Brightness................................ 51 Adjust the Date and Time settings........................... 52 Change the System Language............................... 52 Enable or Disable Clinical Access............................. 53 Enable or Disable Manual Mode Access...................... 54 Set the Pressure Ceiling Limit (Pressure Management)........ 55 Connect a Barcode Reader or Pulse Oximeter................ 56 Connect to a WiFi Network (Available Only in the US)......... 58 Connect to a Local WiFi Network........................ 58 Connect to a Public Network............................ 59 Connect to an Enterprise Network....................... 61 Configure the Network Settings......................... 62 Test the Connection to Electronic Medical Records (EMR) 63 Retrieve Logs............................................... 64 Retrieve the Therapy Logs............................... 65 Retrieve the Error Log................................... 66 Import and Export Device Settings........................... 67 View the Firmware Version and System Information.......... 68 Accessories...................................................... 69 Replaceable Battery......................................... 70 Install the Battery....................................... 71 iv Volara System Instructions for Use (196654 REV 8)  Table of Contents Charge the Battery...................................... 73 Pulse Oximeter.............................................. 74 Mobile Stand and Pole Clamp Assembly...................... 75 Install the Stand......................................... 75 Install the Tray and Pole Clamp.......................... 77 Install the Control Unit on the Cart and Stand Assembly.. 78 Move the Stand......................................... 79 Install the Control Unit on a Medical Rail or IV pole....... 79 Replacement Parts and Kits....................................... 81 Control Unit Parts............................................ 81 Patient Circuits.............................................. 81 Optional Parts........................................... 81 Cleaning and Disinfecting........................................ 82 Clean the Control Unit and Stand............................ 82 Clean the Single Patient Use Circuit—Institutional and Hospital Use.......................................................... 83 Clean the Single Patient Use Circuit—Home Use.............. 84 Clean the Nebulizer Kit....................................... 86 Clean the Pulse Oximeter.................................... 86 Maintenance..................................................... 87 Inlet Filter................................................... 87 Nebulizer Filter.............................................. 88 Fuse......................................................... 88 Automatic Firmware Update (Available Only in the US)....... 89 Expected Life.................................................... 90 Service Calls..................................................... 90 Troubleshooting................................................. 91 Control Unit Does Not Power On............................. 91 On-Screen Help.............................................. 91 Information Indicators....................................... 92 Audio Alerts............................................. 92 Notification Messages................................... 92 Warning Messages...................................... 92 Caution Messages....................................... 93 Storage and Handling............................................ 96 Volara System Instructions for Use (196654 REV 8) v Table of Contents Shipping and Packaging..................................... 97 Shipping for Repair.......................................... 97 Specifications................................................... 98 Product Identification....................................... 98 Product Specifications....................................... 98 Dimensions................................................. 98 Power Requirements........................................ 99 Replaceable Battery (Optional).......................... 99 Environmental Conditions for Use........................... 99 Environmental Conditions for Transport and Storage......... 99 System Cool Down......................................... 100 Wireless Communication................................... 100 Bluetooth.............................................. 100 WiFi (Optional)......................................... 101 Standards and Compliance................................. 101 Essential Performance...................................... 102 Federal Communications Commission (FCC) Compliance Statement................................................. 102 Electromagnetic Compatibility Guidance................... 104 Nebulizer Performance......................................... 108 CHFO Mode................................................ 109 CPEP Mode................................................ 110 Aerosol Mode.............................................. 111 vi Volara System Instructions for Use (196654 REV 8) INDICATIONS FOR USE The Volara System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply. PATIENT POPULATION The Volara System is intended to deliver therapy to adults and children over the age of 2 in the acute care setting. The Volara System is intended to deliver therapy to adults and children over the age of 5 in the home care setting. INTENDED USERS The intended users of the Volara System are the clinicians in the acute care environment. The intended users of the Volara System are the caregivers and patients in the home care environment. The patients are required to be at least 15 years of age and are trained in using the device by Hill-Rom trainers. INTRODUCTION This manual includes instructions for setup, use, and maintenance of the Volara System. Before you operate the system, make sure you have read and understood 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. Volara System Instructions for Use (196654 REV 8) 1 Important Information IMPORTANT INFORMATION This section contains information about the Volara System: Theory of operation (See page 2) Contraindications (See page 3) It is important that you read and understand the information in this section before you use the system. THEORY OF OPERATION The Volara System provides a therapy that enhances secretion mobilization and helps prevent or resolve patchy atelectasis. The system delivers therapy in two modes: CHFO (Continuous High Frequency Oscillation)—a pneumatic form of chest physiotherapy that delivers medicated aerosol while oscillating the airways with continuous pulses of positive pressure. CPEP (Continuous Positive Expiratory Pressure)—supplies continuous positive pressure to help hold open and expand the airways. With both modes, 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. 2 Volara System Instructions for Use (196654 REV 8)  Important Information CONTRAINDICATIONS CONTRAINDICATION: Contraindication—If patient conditions exist that cause the use of the system to be a risk to the patient, do not use the unit. Death or serious injury could occur. ABSOLUTE CONTRAINDICATIONS The Volara System is contraindicated if this patient condition exists: Untreated tension pneumothorax RELATIVE CONTRAINDICATIONS When you use the Volara System, patients with these conditions should be carefully evaluated before a decision is made to use the therapy: History of pneumothorax Pulmonary air leak Recent pneumonectomy Pulmonary hemorrhage Myocardial infarction Vomiting POSSIBLE ADVERSE CONDITIONS When you use 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 hemorrhage Volara System Instructions for Use (196654 REV 8) 3 Symbols and Acronyms SYMBOLS AND ACRONYMS DOCUMENT SYMBOLS This manual contains different typefaces and symbols to make the content easier to read and understand: Standard text—used for regular data. Boldface text—emphasizes a word or phrase and trademarks. NOTE:—sets apart special data or important instruction clarification. CONTRAINDICATION, WARNING or CAUTION – A CONTRAINDICATION identifies situations 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 These symbols may or may not be used on your Volara System: Symbol Definition WARNING Use with Inline Ventilation ONLY Conforms to AAMI STD ES 60601-1, IEC STD 60601-1-6, AAMI STD HA 60601-1-11; Certified to CSA STD C22.2 NO. 60601-1, CSA STD C22.2 NO. 60601-1-11 Follow the operating instructions 4 Volara System Instructions for Use (196654 REV 8)  Symbols and Acronyms Symbol Definition Rating for ingress protection in accordance with IEC 60259 Unique Device Identification information Unique Device Identification Type B equipment with an F-type applied part, according to EN 60601-1 Class II equipment (double insulated), according to EN60601-1 The Volara System conforms to the European Medical Devices Directive 93/42/EEC. Environmental Protection: Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your Local Authority or a retailer for recycling advice. Date of manufacture Manufacturer Serial number Authorized Representative in the European Community Volara System Instructions for Use (196654 REV 8) 5 Symbols and Acronyms Symbol Definition Medical Device Identifies a replaceable fuse link in an electronic circuit Catalog number Non-sterile For multiple use on a single patient Physician prescription required Safe Working Load—includes the weight of control unit and accessories such as patient circuits Mass of the medical equipment Mass (in kilograms (kg)) of the medical equipment including the mass of the control unit, accessories, patient circuits, and the pole clamp assembly Warning—Read the Instructions for Use for safety information on the battery Complies with RTCA/DO-160G Sections 20 and 21 Category M (Applicable only in battery mode.) 6 Volara System Instructions for Use (196654 REV 8)  Symbols and Acronyms Symbol Definition Nebulizer port USB port On/off control Not made with natural rubber latex Temperature for transport and storage Relative humidity for transport and storage Atmospheric pressure for transport and storage Fragile This way up Keep Dry Stacking limit. The maximum number of identical packages which may be stacked on the bottom package. Volara System Instructions for Use (196654 REV 8) 7 Symbols and Acronyms COMMON SCREEN SYMBOLS These symbols may or may not be shown on the touchscreen. Symbol Description The system is connected to the AC power and not powered by the battery. The system is powered by the battery. The system is connected to a WiFi network. The system is transmitting data to the connected WiFi 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 to the user. Heart rate of the patient. Oxygen saturation level of the patient’s blood. 8 Volara System Instructions for Use (196654 REV 8)  Symbols and Acronyms ACRONYMS Acronym Description CHFO Continuous High Frequency Oscillation CPEP Continuous Positive Expiratory Pressure HPP Highest Programed Pressure PC Pressure Ceiling SpO2 Blood Oxygen Saturation Volara System Instructions for Use (196654 REV 8) 9 Safety Instructions SAFETY INSTRUCTIONS When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following important safeguards. READ ALL INSTRUCTIONS BEFORE USING Training is provided by a Hill-Rom qualified trainer or respiratory therapist before the user uses the system for therapy delivery. WARNING: Obey all warnings throughout the manual and also those below to help prevent injury and/or equipment damage: Warning—Only facility-authorized persons should open and service this system. Warning—Federal USA law restricts this product to sale by or on the order of a physician. Sale by or on the order of unauthorized persons can cause patient injury. Warning—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 physical damages, faulty conditions, or malfunction (such as damaged power cord or plug, dropped, dropped in water, or if the touchscreen does not operate). Warning—Do not use the system near to any heat source or ignition source such as a fireplace or radiant heater. Warning—Never drop or insert any object into any opening or hose. Warning—Adult supervision is required to use the therapy on children. Warning—Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities. 10 Volara System Instructions for Use (196654 REV 8)  Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also those below to help prevent injury and/or equipment damage: Warning—Make sure the position of the control unit is such that you can quickly, without obstruction, disconnect the power cord from the power outlet on the wall, if required. Warning—If it is necessary to disconnect/isolate the product from the main power supply, disconnect the power cord plug from the power inlet on the back of the control unit or disconnect the power cord from the power outlet on the wall. Warning—No modification of this product is permitted. Warning—Do not operate the system under harsh conditions (such as extreme temperature, excessive moisture, strong magnetic fields). See Environmental Conditions for Use in “Specifications” on page 98. Warning—Do not operate the system if fluid is spilled on the 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 USB port on the system, except for Hill-Rom approved accessories (See “Accessories” on page 69). The USB port on the back of the system is only for retrieving information as described in this Instructions for Use. Warning—Use only Hill-Rom authorized air hoses and accessories to avoid allergic skin reactions. Warning—Do not store or use the system around pets, pests, or unsupervised children. Warning—Keep the unit, battery, AC/DC power adapter, and power cord away from heated surfaces. Warning—Remove the rechargeable battery from the control unit if the control unit is not going to be used for an extended period of time. Warning—Before cleaning, unplug the system from its power source and remove the battery. Volara System Instructions for Use (196654 REV 8) 11 Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also those below to help prevent injury and/or equipment damage: Warning—Do not allow any metallic conductive objects to contact the battery terminals. Do not short circuit a battery or throw it into the fire; it can explode and cause severe personal injury. Warning—Improper battery use may result in a fire, explosion, or other hazard. Warning—Use only the supplied nebulizer kit in the patient circuit. Always use medication or saline during the Volara therapy to avoid discomfort in the patient’s throat. Warning—Do not use this system without a Smart-Filter. Warning—Do not use the system in a dusty environment. Warning—This product can expose you to chemicals including Nickel and Acrylonitrile which are known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov. Warning—The Volara System is MR Unsafe. Do not expose the system to any magnetic resonance (MR) environment. NOTES: The system may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core. The system may not function properly due to the strong magnetic and radio frequency fields generated by the MR equipment. 12 Volara System Instructions for Use (196654 REV 8)  Safety Instructions CAUTION: Obey all cautions throughout the manual and also those below to help prevent equipment damage: Caution—Read this Instructions for Use before use. Caution—Do not block the air openings of the system or place it on a soft surface, such as a bed or couch, where the air openings may be blocked. Keep the air openings free of lint, hair, and the like. Caution—If there is an ingress of liquids through the case or as a result of not using a Smart-Filter, return the system for factory service. Caution—Use only parts and accessories from Hill-Rom. Do not use any unauthorized parts or accessories with this 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). Caution—If the replaceable battery is used, fully charge the battery to 100% before first time use. Allow up to 8 hours for the initial full battery charge to take place. SAVE THESE INSTRUCTIONS Volara System Instructions for Use (196654 REV 8) 13 Features FEATURES CONTROL UNIT Front Item Description Item Description A Control unit D Therapy port B Touchscreen E Nebulizer port C On/off button F Therapy port cap 14 Volara System Instructions for Use (196654 REV 8)  Features Back Item Description Item Description G Handle L Fuse holder H Replaceable battery M Air inlet filter (optional) I Ventilation fan N Nebulizer filter J Power inlet O Patient circuit holder K USB port Volara System Instructions for Use (196654 REV 8) 15 Features SINGLE PATIENT USE CIRCUIT Item Description Item Description A Smart-Filter H Face mask (optional) B Breathing hose I Mouthpiece C Handset J Clear spontaneous breathing adapter 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 N In-line ventilator adapter, adapter (optional) 22 mm x 15 mm (optional) NOTE: Optional parts are provided according to the configuration you have ordered. 16 Volara System Instructions for Use (196654 REV 8)  Assemble and Connect the Patient Circuit ASSEMBLE AND CONNECT THE PATIENT CIRCUIT WARNING: To help prevent injury and/or equipment damage, obey these warnings: Warning—Do not operate the system unless a Smart-Filter is attached to the system. Warning—Do not use excessive force when assembling or disassembling the patient circuit. This helps to avoid damage to the components. Warning—To avoid cross-contamination, always use a new patient circuit when using the system on a new patient. Warning—Discard the circuit in accordance with facility protocols. 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 Smart-Filter are damaged or visibly soiled, replace them. See “Replacement Parts and Kits” on page 81. The system keeps a log of the number of use cycles for the patient circuit. If a patient circuit is used beyond its recommended usable life, the system notifies the user and will not operate further. Replace the patient circuit with a new circuit to continue with the therapy. Connect the correct patient circuit for each form of therapy. See page 18. Volara System Instructions for Use (196654 REV 8) 17 Assemble and Connect the Patient Circuit CONNECT THE PATIENT CIRCUIT WARNING: 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. NOTE: Make sure the Smart-Filter is always kept dry. 1. Attach one end of the breathing hose (A) to the smaller end of the Smart- Filter (B). NOTE: Make sure the breathing hose (A) fits to the position shown on the Smart-Filter (B). Avoid inserting the breathing hose (A) beyond the marked line as this makes it difficult to disconnect the parts for cleaning later. 18 Volara System Instructions for Use (196654 REV 8)  Assemble and Connect the Patient Circuit 2. Align the larger end of the Smart-Filter (B) with the therapy port on the control unit. 3. Gently turn the Smart-Filter (B) to secure it to the therapy port. NOTE: Make sure the frosted part of the Smart- Filter covers the therapy port entirely. 4. Connect the other end of the breathing hose (A) to the inlet port of the handset (E). 5. Connect the other side of the handset (E) to the front of the clear spontaneous breathing adapter (G). Expiratory ports WARNING: Warning—During the therapy, make sure the expiratory ports on the clear spontaneous breathing adapter are not blocked. This helps prevent carbon dioxide from accumulating in the system. 6. Align the arrow on the clear spontaneous breathing adapter to the “unlocked” symbol on the handset adapter. Connect and twist the parts until they lock into position. 7. Connect the applicable patient interface: Mouthpiece (H)—Insert and twist the mouthpiece (H) into the output port of the clear spontaneous breathing adapter (G). Volara System Instructions for Use (196654 REV 8) 19 Assemble and Connect the Patient Circuit Face mask (J)— a. Insert and gently twist the adapter (I) into the output port of the clear spontaneous breathing adapter (G). b. Connect the other end of the adapter (I) to the face mask (J). NOTE: It may be difficult to connect the adapter to the face mask. If needed, apply more pressure when you are connecting the two parts. Flexible tracheostomy adapter (K)— a. Insert and gently twist the adapter (I) into the output port of the clear spontaneous breathing adapter (G). b. Connect the other end of the adapter (I) to the flexible tracheostomy adapter (K). c. Connect the other end of the flexible tracheostomy adapter to the tracheostomy tube (patient’s own). 8. Assemble the nebulizer kit and add the prescribed medication or saline. See page 22. WARNING: Warning—Make sure the Volara therapy is always administered with medication or saline to avoid discomfort to the patient’s throat. NOTE: If the nebulizer kit is not used, make sure the handset plug (L) is installed tightly to cover the nebulizer port on the handset (G). 20 Volara System Instructions for Use (196654 REV 8)  Assemble and Connect the Patient Circuit Connect the Patient Circuit to an Oxygen Source WARNING: To help prevent injury and/or equipment damage, obey these warnings: Warning—Do not connect the system to an unregulated or high- 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 prevent oxygen from accumulating in the system. 1. Connect the patient circuit. Do Step 1 through Step 6 on page 18. 2. Connect the smaller end of the oxygen bleed-in adapter (M) to the output port of the clear spontaneous breathing adapter (G). 3. Connect the applicable patient interface to the other end of the oxygen bleed-in adapter (M). 4. Connect the oxygen bleed-in adapter (M) to the oxygen tubing from the oxygen source (for example, a flow- meter or oxygen concentrator). Volara System Instructions for Use (196654 REV 8) 21 Assemble and Connect the Patient Circuit Assemble the Nebulizer Kit and Add Medication CAUTION: Caution—The fill volume of the nebulizer cup is 2 to 10 ml. Do not fill the cup outside of these limits. 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 or saline. 3. Replace the lid. 4. Attach one end of the nebulizer tubing to the nebulizer port on the control unit. 22 Volara System Instructions for Use (196654 REV 8)  Assemble and Connect the Patient Circuit 5. Attach the other end of the nebulizer tubing to the base of the nebulizer cup. 6. Connect the nebulizer lid attached with the cup to the nebulizer port of the clear spontaneous breathing adapter or blue ventilator adapter. 7. If you are using a mouthpiece, face mask, or connecting the patient circuit directly to a tracheostomy tube— connect the nebulizer kit to the nebulizer port of the clear spontaneous breathing adapter. The nebulizer kit is now connected to the patient circuit and control unit. Using a Bacterial Filter In-line with the Volara System The recommendations in this section should be used in a supportive manner and are not intended to be used as the primary instructions for use of the device or the therapy. You can use a bacterial filter in-line with the Maximus and Volara Systems with the patient circuit configuration shown below. Specifications of the bacterial filter that can be used are: Bacterial Filtration efficiency: ≥ 99% Viral Filtration efficiency: ≥ 99% Low Flow Resistance: ≤ 2.0 cm H20 at 60 LPM Dead Space: ≤ 45 mL ISO 5356 connector: One end: 15 mm inside diameter / 22 mm outside diameter Opposite end: 22 mm inside diameter NOTES: Follow the methods of use recommended by the filter manufacturer (such as the number of treatments or days of use). Before you start, make sure the patient circuit is assembled. See “Assemble and Connect the Patient Circuit” on page 17. Volara System Instructions for Use (196654 REV 8) 23 Set Up and Power On the Control Unit SET UP AND POWER ON THE CONTROL UNIT CAUTION: Caution—Never block the air openings of the system or set it on a soft surface, such as a bed or couch, where the air openings may be blocked. Keep the air openings free of lint, hair, and the like. Otherwise, equipment damage could occur. NOTES: If the control unit is taken out from storage, do the following before use: – Allow the control unit to warm up in an ambient environment of 68°F (20°C) for at least 45 minutes when removed from a storage temperature of -4°F (-20°C) or colder. – Allow the control unit to cool down in an ambient environment 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 75. 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 that apply to the power source to use: AC power— a. Connect the power cord to the back of the control unit. b. Connect the other end to an applicable power outlet. NOTE: The power cord shown is for illustrative purposes and may differ from the one required for your country. 24 Volara System Instructions for Use (196654 REV 8)  Set Up and Power On the Control Unit Battery power— a. Turn the patient circuit holder aside to get access to the battery compartment. c b. Remove the battery cover (if installed). d c. Insert the right side of the battery (with LED indicator) into the battery compartment first. d. Insert the left side of the battery until the battery locks into position. 3. Press and hold the On/Off button on the control unit for at least 5 seconds. The Hillrom screen shows. 4. To start a therapy, see “Volara Therapy” on page 27. Volara System Instructions for Use (196654 REV 8) 25 Power Off the Control Unit and Store the System POWER OFF THE CONTROL UNIT AND STORE THE SYSTEM When the therapy is complete, do these steps: 1. Press and hold the On/Off button for at least 5 seconds. If the system is operating on AC power, the system enters into sleep mode. If the system is operating on battery power, the system 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. Disconnect the patient circuit and accessories from the control unit. 3. Clean the control unit, patient circuit, and accessories. Follow the instructions in “Optional Parts” on page 81, or according to facility protocols. 4. Store the control unit, patient circuit, and accessories. See “Storage and Handling” on page 96. 26 Volara System Instructions for Use (196654 REV 8)  Volara Therapy VOLARA THERAPY ABOUT THE HOME MENU Item Description A Automatic therapy mode B Manual therapy mode Volara System Instructions for Use (196654 REV 8) 27 Volara Therapy ABOUT THE OPTIONS MENU Item Option Description A Home—Go to the Home menu. B Care Plan—Access the preset therapy settings. C Device Settings—Access the device control settings, enable clinical access, retrieve logs, and configure connections to accessories. D Help—See information to guide you in using the system. E Options tab Access or exit the Options menu. 28 Volara System Instructions for Use (196654 REV 8)  Volara Therapy START A THERAPY NOTES: Always use the settings prescribed by the physician. Avoid operating the touchscreen with wet fingers as this will reduce the screen response time. For home use, the maximum pressure setting is 50 cmH2O. Volara therapy is available in both automatic and manual modes. 1. Select a therapy mode. If possible, have the patient sit in an upright position. 2. Before you start the therapy, 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. WARNING: Warning—The use of a face mask may result in discomfort, vomiting, or breathlessness in some patients. Face mask—tightly, but comfortably, cover the sides of the patient’s mouth, bridge of the nose, and below the lower lip. 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 Volara System Instructions for Use (196654 REV 8) 29 Volara Therapy sure that the patient maintains a tight seal on the mouthpiece during the therapy. Flexible tracheostomy adapter—if the patient has a tracheostomy tube or endotracheal tube, use the flexible tracheostomy adapter to connect the tracheal tube to the system. See Step 7 on page 19. 3. Follow the steps for each therapy mode: Automatic mode—see “Volara Therapy in Automatic Mode” on page 31. Manual mode—see “Volara Therapy in Manual Mode” on page 37. 30 Volara System Instructions for Use (196654 REV 8)  Volara Therapy VOLARA THERAPY IN AUTOMATIC MODE Basic View in Automatic Mode Item Description Item Description A Name of the preset F Options tab therapy selected B Digital manometer G Remaining therapy time C Therapy status H Current stage of total stages set in the preset therapy D Heart rate and pulse I In-Therapy edit control oximeter readings (Available only if Clinical (Available only if a pulse Access is enabled.) oximeter is connected.) E Start/stop/resume/ pause controls Volara System Instructions for Use (196654 REV 8) 31 Volara Therapy Start a Therapy in Automatic Mode NOTE: Before you start a therapy, make sure you have connected the applicable patient circuit to the system. See “Connect the Patient Circuit” on page 18. 1. Press Automatic. When prompted, scan the patient’s ID barcode with the paired barcode reader. For pairing instructions, see page 56. The last used preset therapy shows. 2. Place the patient interface in position on the patient. See Step 7 on page 19. 3. To continue with this therapy, press Start. Or, do these steps to select another preset: a. Swipe the Options tab left, and press Care Plan. b. Select the preferred preset therapy plan. c. Examine the therapy settings t o make sure they match the prescription.. d. Press Start. The therapy starts. 32 Volara System Instructions for Use (196654 REV 8)  Volara Therapy During the therapy, you can pause or stop a therapy. Or, press Resume to continue a paused therapy session. NOTE: If a therapy is paused for more than 5 minutes, the therapy stops and a warning message shows. Follow the on-screen instructions. When the therapy is stopped or complete, the therapy summary shows. Note the number of treatment sessions completed with the connected patient circuit. Number of times the patient circuit has been used Maximum number of times the patient circuit can be used 4. Press Back to go to the initial therapy screen. Volara System Instructions for Use (196654 REV 8) 33 Volara Therapy Adjust In-Therapy Settings in Automatic Mode NOTE: Available only if Clinical Access is enabled. See page 53. When a therapy is in progress, you can use the In-Therapy Edit control to adjust these therapy settings— pressure frequency (in CHFO stage) turn on or off the nebulizer 1. During the therapy, press the In- Therapy Edit control to adjust the therapy settings. The In-Therapy Edit screen shows. WARNING: Warning—Do not increase the pressure settings beyond the physician’s prescription. Exceeding the prescribed pressure settings could cause lung collapse or pneumothorax. Limit the use of excessive pressures that exceed 50 cmH2O on pediatric patients. 2. Use the + or - control to adjust the pressure setting. NOTE: The maximum pressure that can be set depends on the pressure ceiling limit defined in the Pressure Management settings. See page 55. Nebulizer—Slide the setting to ON or OFF to turn on or off the nebulizer. 3. Adjust the Frequency in CHFO stage of the therapy. 34 Volara System Instructions for Use (196654 REV 8)  Volara Therapy If required, press Low, Med, or High to toggle between different intensities of frequency during the therapy. 4. Press Done to go to the therapy screen. 5. Press Apply to All to apply the new settings to all the remaining CPEP or CHFO stages in the therapy. A blue check mark shows when all the new settings are applied. NOTE: The new settings are applied to the related stage on which the adjustment is done. NOTES: If the remaining stage time is less than 10 seconds, then the In- Therapy Edit screen closes automatically and the In-Therapy Edit control becomes unavailable. When the next stage starts, the In-Therapy Edit control is available again. Volara System Instructions for Use (196654 REV 8) 35 Volara Therapy Adjust the Cough Pause Settings NOTE: Applicable only to preset therapy plans. 1. Press Automatic. When prompted, scan the patient’s ID barcode with the paired barcode reader. For pairing instructions, see page 56. 2. Before you start the therapy, swipe the Options tab left, and press Care Plan. 3. Select a preset therapy plan, and press Options. 4. Slide Cough Pause to ON. 5. To modify the interval and duration of the Cough Pause therapy, select each setting and do these steps: a. Use the + or – control to adjust the setting. Or, select the setting and use the keypad control to enter the required setting. b. Press Save to save the changes. Or, press Cancel. 6. When you have made all adjustments, press Therapy to exit. 7. Press Start. The therapy starts. 36 Volara System Instructions for Use (196654 REV 8)  Volara Therapy VOLARA THERAPY IN MANUAL MODE WARNING: Warning—Due to the complexity of the device, the manual mode is locked by default and only intended for advanced users who demonstrate device competency after receiving clinical training. NOTE: Only advanced users with the Clinical Access key code can unlock the manual mode. See “Enable or Disable Manual Mode Access” on page 54. Basic View in Manual Mode Item Description Item Description A Digital manometer F Options tab B Therapy status and G Total therapy time control C Heart rate and pulse H Number of stages oximeter readings delivered for each CPEP or (Available only if a pulse CHFO stage oximeter is connected.) D Start/stop control I Therapy time for the current CPEP or CHFO stage E CHFO frequency control Volara System Instructions for Use (196654 REV 8) 37 Volara Therapy Start a Therapy in Manual Mode NOTE: Before you start a therapy, make sure you have connected the applicable patient circuit to the system. See “Connect the Patient Circuit” on page 18. 1. Press Manual. When prompted, scan the patient’s ID barcode with the paired barcode reader. For pairing instructions, see page 56. The last used therapy settings show. WARNING: Warning—Do not increase the pressure settings beyond the physician's prescription. Exceeding the prescribed pressure settings could cause lung collapse or pneumothorax. Limit the use of excessive pressures that exceed 50 cmH2O on pediatric patients. 2. Use the + or – control to adjust the setting. Or, select the setting and 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 Pressure Management settings. See page 54. 3. Press Enter to confirm the setting. 38 Volara System Instructions for Use (196654 REV 8)  Volara Therapy If required, press the CHFO Freq. control and select the preferred frequency. GUI Map Pg 49 BM1.11 If a nebulizer is used, press the nebulizer icon to enable therapy with a nebulizer. The nebulizer icon lights up. 4. Place the patient interface in position on the patient. See Step 7 on page 19. 5. Press Start. NOTE: This does not start the therapy, but starts the air pump in the control unit. 6. When the system is ready, the CPEP and/or CHFO controls light up. To start the therapy, press CPEP or CHFO. NOTE: During the therapy, follow these guidelines: 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. Volara System Instructions for Use (196654 REV 8) 39 Volara Therapy 7. When the therapy is complete, press Stop. The therapy summary shows. Note the number of treatment sessions completed with the connected patient circuit. Number of times the patient circuit has been used Maximum number of times the patient circuit can be used 8. Press Back to go back to the manual therapy screen. 9. To go to the Home menu, swipe the Options tab left, and press Home. 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 5 minutes, a warning message shows. 40 Volara System Instructions for Use (196654 REV 8)  Volara Therapy VOLARA THERAPY WITH AN IN-LINE VENTILATOR WARNING: Obey these warnings to help prevent patient injury and/or equipment damage: Warning—Only persons trained to use the Volara System and ventilators should provide therapy to ventilated patients. Warning—Do not deliver any other modes of therapy except CHFO during in-line use with a ventilator. There is no need for CPEP as this therapy can be delivered by the ventilator alone. Frequency of Use In-line use of the Volara System with a ventilator ranges in frequency from 4 to 8 times daily as determined by the patient’s response to the therapy. Procedures 1. Before you start a therapy session, make sure that the system operates correctly. If possible, the patient should be in a position such that the head of the bed is at an angle greater than 30 degrees. 2. Assemble the patient circuit. Do steps Step 1 to Step 4 in “Connect the Patient Circuit” on page 18. 3. Connect the handset (E) to the front of the blue ventilator adapter (F) and twist the parts until they lock into position. 4. Connect the in-line ventilator adapter (G) to the output port of the blue I ventilator adapter (F). NOTE: If required, attach the oxygen bleed-in adapter to the output port of the blue ventilator adapter (F). 5. Fill the nebulizer with the prescribed medication or saline, as applicable. See “Assemble the Nebulizer Kit and Add Medication” on page 22. If the nebulizer is not used, make sure the handset plug is installed tightly to cover the nebulizer port on the blue ventilator adapter. Volara System Instructions for Use (196654 REV 8) 41 Volara Therapy 6. Connect a spring-valve “tee” adapter (N—patient’s own) into the inspiratory limb of the ventilator breathing circuit. 7. Start the therapy. See “Volara Therapy in Automatic Mode” on page 31 or “Volara Therapy in Manual Mode” on page 37. 8. Connect the other end of the in-line ventilator adapter to the port of the spring-valve “tee” adapter (N). NOTE: When delivering the Volara therapy on ventilated patients, start the therapy before you connect the patient circuit in-line. You may see an increase in the pressure reading when the patient circuit is initially placed in-line. 42 Volara System Instructions for Use (196654 REV 8)  Volara Therapy ADVANCED VOLARA THERAPY SETTINGS These settings allow you to create, modify, rename, and delete a preset therapy. Create a New Preset Therapy Plan NOTE: Available only if Clinical Access is enabled. See page 53. 1. Press Automatic. 2. Swipe the Options tab left, and press Care Plan. 3. Select an empty preset plan, and select 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, press Proceed to continue, or press Cancel. NOTE: Default pressure limits for each new stage are: CPEP—25 cmH2O CHFO—50 cmH2O or the limit set in Clinical Access NEB—5 cmH2O Volara System Instructions for Use (196654 REV 8) 43 Volara Therapy 5. Press the down arrow and select the preferred option: CPEP—Set the therapy pressure, therapy duration, and enable or disable the use of a nebulizer. CHFO—Set 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. 6. Press the setting to adjust the pressure setting. GUI Map Rev 6 Page 46 TP1.13 WARNING: Warning—Do not increase the pressure settings beyond the physician's prescription. Exceeding the prescribed pressure settings could cause lung collapse or pneumothorax. Limit the use of excessive pressures that exceed 50 cmH2O on pediatric patients. 7. Use the + or – control to adjust the setting. Or, select the setting and use the keypad control to enter the GUI Map Rev 6 Page required setting. 46 TP1.13 44 Volara System Instructions for Use (196654 REV 8)  Volara Therapy NOTE: The maximum pressure that can be set depends on the pressure ceiling limit defined in the Pressure Management settings. See page 54. 8. Press Save to save the changes. Or, press Cancel. 9. To add more stages, do Step 4 to Step 8. 10. If Cough Pause is required in this therapy— a. Press Options. b. Slide Cough Pause to ON. c. Select the setting to adjust the interval and duration of the cough pause therapy. d. Use the + or – control to adjust the setting. Or, select the setting and use the keypad control to enter the required setting. e. Press Save to save the changes. Or, press Cancel. 11. When you have completed the changes, press Done. The therapy screen shows. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. See page 53. Press Device, and press Controls. Slide Clinical Access to OFF. 12. To start a therapy with the new preset therapy, swipe the Options tab left, and press Care Plan. Volara System Instructions for Use (196654 REV 8) 45 Volara Therapy 13. Select the new preset therapy, and press Start. The therapy starts. Modify a Preset Therapy Plan 1. Press Automatic. 2. Swipe the Options tab left, and press Care Plan. 3. Select a preset therapy plan to modify. 4. Press Edit. 5. When prompted, press Modify. 6. Swipe right or left to select the stage to modify. 7. Press the down arrow, and select the option to modify: CPEP—Modify the therapy pressure, therapy duration, and enable or disable the use of a nebulizer. 46 Volara System Instructions for Use (196654 REV 8)  Volara Therapy 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. 8. Select the pressure setting to adjust. GUI Map Rev 6 Page 46 TP1.13 WARNING: Warning—Do not increase the pressure settings beyond the physician's prescription. Exceeding the prescribed pressure settings could cause lung collapse or pneumothorax. Limit the use of excessive pressures that exceed 50 cmH2O on pediatric patients. 9. Use the + or – control to adjust the setting. Or, select the setting and use the keypad control to enter the required GUI Map Rev 6 Page setting. 46 TP1.13 NOTE: The maximum pressure that can be set depends on the pressure ceiling limit defined in the Pressure Management settings. See page 54. 10. Press Save to save the changes. Or, press Cancel. Volara System Instructions for Use (196654 REV 8) 47 Volara Therapy To turn Cough Pause on or off, press Options and slide the setting to ON or OFF. If Cough Pause is enabled, select the setting to adjust the interval and duration of the cough pause. a. Use the + or – control to adjust the setting. Or, select the setting and use the keypad control to enter the required setting. b. Press Save to save the changes. Or, press Cancel. c. When all adjustments are made, press Therapy to exit. 11. To confirm all changes, press Done. The therapy screen shows. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. See page 53. Press Device, and press Controls. Slide Clinical Access to OFF. 48 Volara System Instructions for Use (196654 REV 8)  Volara Therapy Rename a Preset Therapy Plan 1. Select the preset therapy plan to rename. 2. Press and hold the therapy plan until the on-screen keyboard shows. 3. Use the on-screen keyboard to enter any 5 alphanumeric characters for the new name. 4. Press Enter when complete. Or, press Cancel. The preset therapy is renamed. Volara System Instructions for Use (196654 REV 8) 49 Volara Therapy Delete a Preset Therapy Plan NOTE: Available only if Clinical Access is enabled. See page 53. 1. Press Automatic. 2. Swipe the Options tab left, and press Care Plan. 3. Select the preset therapy plan to delete. 4. Press Edit. 5. When prompted, press Delete.. 6. Press Proceed to delete the plan. Or, press Cancel. The Care Plan screen shows and the selected preset therapy is removed. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. See page 53. Press Device, and press Controls. Slide Clinical Access to OFF. 50 Volara System Instructions for Use (196654 REV 8)  Device Settings DEVICE SETTINGS Swipe the Options tab left, and press Device Settings. In Device Settings, you can— Adjust the screen brightness Adjust the date and time Change the system menu language Enable or disable Clinical Access Enable or disable Manual Mode Access Connect to a Bluetooth device Connect to a wireless connection (WiFi) Retrieve logs View the firmware version and system information ADJUST THE SCREEN BRIGHTNESS 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 Home to exit. Volara System Instructions for Use (196654 REV 8) 51 Device Settings ADJUST THE DATE AND TIME SETTINGS 1. Press Device, and press Date-Time. 2. Move the slider to select the preferred setting for 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 Home to exit. CHANGE THE SYSTEM LANGUAGE 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, press Save. Or, press Cancel. 4. When complete, press Home to exit. 52 Volara System Instructions for Use (196654 REV 8)  Device Settings ENABLE OR DISABLE CLINICAL ACCESS Clinical Access allows facility-authorized persons to access and set up these features: Set the maximum pressure ceiling setting available to the user Modify preset therapy settings Import and export device settings Enable or disable Manual Mode Access Set up and pair Bluetooth devices, such as a barcode reader or pulse oximeter Import the Health Level 7 (HL7) standard file Adjust the In-Therapy settings during the Volara therapy (Only available in automatic mode.) 1. Press Device, and press Controls. 2. Slide Clinical Access to ON. To disable, slide the setting to OFF. The user will not be able to access the manual modes or modify any preset therapy plans. 3. Enter the access key code, and press Enter. If applicable, contact your facility administrator for the key code. 4. When complete, press Home to exit. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. 1. Press Controls, and slide Clinical Access to OFF. 2. Press Home to exit. Volara System Instructions for Use (196654 REV 8) 53 Device Settings ENABLE OR DISABLE MANUAL MODE ACCESS WARNING: Warning—Due to the complexity of the device, the manual mode is locked by default and only intended for advanced users who demonstrate device competency after receiving clinical training. NOTE: Available only if Clinical Access is enabled. See page 53. 1. Press Device, and press Controls. 2. Slide Clinical Access to ON. 3. Enter the access key code, and press Enter. 4. Slide Manual Mode Access to ON. The user can now access manual modes. To disable the access, slide the setting to OFF. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. See page 53. 1. Press Controls, and slide Clinical Access to OFF. 2. Press Home to exit. 54 Volara System Instructions for Use (196654 REV 8)  Device Settings SET THE PRESSURE CEILING LIMIT (PRESSURE MANAGEMENT) The Pressure Management feature allows facility-authorized persons to control the maximum pressure selection by setting a pressure ceiling limit. The user is prevented from setting a therapy pressure that exceeds the limit defined in the device settings. WARNING: Warning—To avoid patient injury, this setting should only be configured by facility-authorized persons. NOTE: Available only if Clinical Access is enabled. See page 53. 1. Press Device, and press Controls. 2. Slide Clinical Access to ON. 3. Enter the access key code, and press Enter. The default pressure ceiling shows on- screen. NOTE: The pressure management settings show: Pressure Ceiling (PC)—the maximum therapy pressure that can be selected by the user in manual mode or when modifying a preset plan. Highest Programed Pressure (HPP)—the highest therapy pressure that has been programed in both automatic and manual modes in this system. Volara System Instructions for Use (196654 REV 8) 55 Device Settings 4. 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 to 70 cmH2O and is limited to the HPP gathered from the system. The PC must be equal to 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 of 44 cmH2O or lower. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. See page 53. Press Controls, and slide Clinical Access to OFF. Press Home to exit. CONNECT A BARCODE READER OR PULSE OXIMETER NOTES: Available only if Clinical Access is enabled. See page 53. For Bluetooth detection, have the barcode reader or pulse oximeter within one meter (3') of the system. 1. Power on the control unit and the device for pairing. 2. Press Device, and press Controls. 3. Slide the setting for Barcode Detection to ON. 56 Volara System Instructions for Use (196654 REV 8)  Device Settings 4. Press Connect. 5. Slide the setting for Bluetooth to ON. 6. Press 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. – Use the on-screen keyboard to enter the MAC address, then press Enter to confirm the entry. 7. When prompted to pair the new device, press Proceed. Or, press Cancel. When the device is paired, a check mark shows next to the device name in the list of Available Devices. NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. See page 53. Press Device, and press Controls. Slide Clinical Access to OFF. 8. When complete, press Home to exit. Volara System Instructions for Use (196654 REV 8) 57 Device Settings CONNECT TO A WIFI NETWORK (AVAILABLE ONLY IN THE US) This feature is only available on systems ordered with WiFi capability. NOTES: After the first time connection, the WiFi will automatically connect when the Volara System is turned on and within the range of the WiFi network. Data will transmit automatically at the end of each therapy session, or when the Volara System is powered up the next time. Connect to a Local WiFi Network 1. Swipe the Options tab left, and press Device Settings. 2. Press Connect. 3. Press WiFi, and slide the setting to ON. 4. Press Scan to search for available wireless networks. Depending on the number of networks available, the scan may take a few minutes. When complete, a list of wireless networks shows. 58 Volara System Instructions for Use (196654 REV 8)  Device Settings 5. Select the network to join. 6. Use the on-screen keyboard to enter the network Password. 7. To confirm the entry, press Enter. Or, press Cancel. 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. 8. To view the status of the connection, press Status. 9. When complete, press Home to exit. Connect to a Public Network NOTE: Do not connect to a public WiFi if any Terms and Conditions must be accepted to use the public WiFi. 1. Swipe the Options tab left, and press Device Settings. Volara System Instructions for Use (196654 REV 8) 59 Device Settings 2. Press Connect. 3. Press WiFi, and slide the setting to ON. 4. Press Scan to locate the wireless networks available. Depending on the number of networks available, the scan may take a few minutes. When complete, a list of wireless networks shows. 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. 5. To view the status of the connection, press Status. 6. Press Home to exit. 60 Volara System Instructions for Use (196654 REV 8)  Device Settings Connect to an Enterprise Network 1. Swipe the Options tab left, and press Device Settings. 2. Press Connect. 3. Press WiFi, and slide the setting to ON. 4. Press Scan to search for wireless networks available. Depending on the number of networks available, the scan may take a few minutes. When complete, a list of wireless networks shows. 5. Select the network to join. 6. When prompted, use the on-screen keyboard to enter the User ID and Password. 7. To confirm, press Proceed. Or, press Cancel. When the connection is successful, a green check mark shows next to the access point name. NOTE: To enter specific server settings, see “Configure the Network Settings” on page 62. Volara System Instructions for Use (196654 REV 8) 61 Device Settings If the connection is unsuccessful, an error message shows. Press Return to go to the previous screens and make your entries again. 8. Press Home to exit. Configure the Network Settings 1. After the Volara System is connected to the WiFi network, press Settings. 2. Depending on the configuration, do one of these settings: For assignment of automatic IP address by the DHCP server, slide the setting to DHCP. For configuration of the manual IP address, slide the setting to Static. 3. Select each field and use the on-screen keypad to enter the settings for: IP Address Gateway Subnet DNS 4. After all entries are made, press on the yellow highlighted field of your last entry to close the keypad. 62 Volara System Instructions for Use (196654 REV 8)  Device Settings 5. Slide WiFi to OFF and back to ON again to reset the WiFi connection. The network settings are applied. 6. Press Home to exit. Test the Connection to Electronic Medical Records (EMR) If you have an EMR account assigned by the medical facility, you can submit the therapy data from the Volara System to update your EMR. Before you start the therapy, make sure to test the connection and connect the system to the EMR portal. 1. After the Volara System is connected to the WiFi network, press Settings. 2. Slide the server option to EMR. Volara System Instructions for Use (196654 REV 8) 63 Device Settings 3. Select each 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 yellow highlighted field to close the keypad. 5. To test the entries made, press Test Connection. 6. When 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. 7. Press Return to exit. 8. To confirm the settings entered, slide WiFi to OFF, then ON again. 9. Press Home to exit. RETRIEVE LOGS You can retrieve therapy logs and error logs from this system. NOTE: Before you start, format the USB drive to FAT16 or FAT32 format on your computer. This action deletes all information currently stored on the USB drive. 64 Volara System Instructions for Use (196654 REV 8)  Device Settings Retrieve the Therapy Logs 1. Swipe the Options tab left, and press Device Settings. 2. Select Data. NOTE: Not all options are available at the same time. 3. To view the Therapy Log, select Review. A list of therapy sessions shows. 4. Select the date and time of the session on the left hand panel. The session information shows on the right panel. 5. Press Back to go to the Data screen. 6. To export all the therapy logs, connect the USB drive to the port on the back of the control unit. 7. At Therapy Log, select Export. Exporting starts. When exporting is complete, a confirmation screen shows. 8. Press Return to go to the Data screen. 9. Press Home to exit. Volara System Instructions for Use (196654 REV 8) 65 Device Settings Retrieve the Error Log 1. Swipe the Options tab left, and press Device Settings. 2. Select Data. NOTE: Not all options are available at the same time. 3. To view the Error Log, select Review. A list of errors shows. 4. Select the date and time of the session on the left hand panel. Errors that occurred at that time show on the right panel. 5. Press Back to go to the Data screen. 6. To export the Error Log, connect the USB drive to the port on the back of the control unit. 7. At Error Log, select Export. Exporting begins. When exporting is complete, a confirmation screen shows. 8. Press Return to go to the Data screen. 9. Press Home to exit. 66 Volara System Instructions for Use (196654 REV 8)  Device Settings IMPORT AND EXPORT DEVICE SETTINGS You can export the settings from one system and import the settings into another system. NOTES: Before you start, format the USB drive to FAT16 or FAT32 format on your computer. This action deletes all information currently stored on the USB drive. Available only if Clinical Access is enabled. See page 53. 1. Swipe the Options tab left, and press Device Settings. 2. Select Data. NOTE: Not all options are available at the same time. 3. Connect the USB drive to the USB port on the back of the control unit. To export settings—at Device Settings, press Export. When the exporting is complete, remove the USB drive. To import settings— a. At Device Settings, press Import. b. When the settings are successfully imported, a confirmation message shows and the system restarts. Volara System Instructions for Use (196654 REV 8) 67 Device Settings NOTE: To prevent unauthorized persons from adjusting the settings, disable Clinical Access after you have adjusted the settings. Press Device, and press Controls. Slide Clinical Access to OFF. VIEW THE FIRMWARE VERSION AND SYSTEM INFORMATION Swipe the Options tab left, and press Device Settings. The Device Information shows. 68 Volara System Instructions for Use (196654 REV 8)  Accessories ACCESSORIES Item Part Number Replaceable Battery 194566S See page 70. Pulse Oximeter, Bluetooth 196694 See page 74. WiFi Module, USB 198658 Pole Clamp Assembly M08235 See page 75. Stand and Cart Assembly M08177 (with Pole Clamp) See page 75. Carrying Case 209558 Volara System Instructions for Use (196654 REV 8) 69 Accessories REPLACEABLE BATTERY Use only the Hill-Rom approved battery (194566S). The Volara System can be powered by a Lithium-ion battery when AC power is not available. A fully charged new battery can support 6 sessions of a typical Volara therapy. WARNING: Obey these warnings to help prevent patient injury and/or equipment damage: Warning—Do not ship the battery with over a 30% charge. 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 the Hill-Rom approved battery (194566S). Caution—Fully charge the battery to 100% before the first time use. Allow for up to 8 hours to fully charge the battery. Subsequent battery recharge periods will take less time. NOTE: If the replaceable battery is unable to support at least 2 therapy sessions, replace the battery with a new and freshly charged battery. See “Replacement Parts and Kits” on page 81. For disposal of the battery, consult your local regulations to safely discard or recycle the battery. If you return the control unit for repairs, do not return the battery unless specifically requested by customer service. 70 Volara System Instructions for Use (196654 REV 8)  Accessories Install the Battery 1. Turn the patient circuit holder aside to get access to the battery compartment. 2. Remove the battery cover (if installed). 3. Insert the right side of the battery (with LED indicator) into the battery compartment first. 4. Insert the left side of the battery until the battery locks into position. 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. Fully Locked Unlocked Volara System Instructions for Use (196654 REV 8) 71 Accessories When the replaceable battery is installed in the control unit, the battery symbol shows on the touchscreen. The battery symbol shows the battery status: 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 contact with the battery and is not powered by the battery. 72 Volara System Instructions for Use (196654 REV 8)  Accessories You can also check the battery charge at the battery. To do so, press the button next to the LED indicator. LED indicator Battery Status Four green bars The battery is fully charged. Blinking bars The battery charge is low. Blinking bars when the control The battery is charging. unit is connected to AC power. Charge the Battery CAUTION: Caution—Charge the battery only with the control unit to prevent equipment 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 an applicable power outlet. Volara System Instructions for Use (196654 REV 8) 73 Accessories PULSE OXIMETER NOTE: Use only the Hill-Rom approved pulse 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 on the control unit touchscreen. 74 Volara System Instructions for Use (196654 REV 8)  Accessories MOBILE STAND AND POLE CLAMP ASSEMBLY NOTE: Use only the Hill-Rom approved mobile stand and pole clamp assembly (M08177). Install 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 attach the stand base to the pole. 4. Turn the hex wrench clockwise to tighten the screw. Volara System Instructions for Use (196654 REV 8) 75 Accessories 5. Install the top pole into the stand base. Make sure the groove is aligned with its opening on the bottom pole. 6. Use the hex wrench to tighten the pole connection. 76 Volara System Instructions for Use (196654 REV 8)  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. Volara System Instructions for Use (196654 REV 8) 77 Accessories Install the Control Unit on the Cart and Stand Assembly 1. Find the preferred position 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. 78 Volara System Instructions for Use (196654 REV 8)  Accessories Move the Stand CAUTION: Obey these cautions to help prevent equipment damage: Caution—Do not apply force or pull the control unit when it is connected to the oxygen source. Caution—Do not pull the control unit using the breathing hose or circuit tubing during transportation. 1. Power off the control unit and unplug the power cord from the power outlet. Stow the power cord on the basket of the stand. 2. Disconnect the oxygen tubing from the facility connection (if connected). 3. Unlock the locking casters. 4. Move the stand to the applicable location. 5. Lock the casters. 6. Plug the power cord into the power outlet. Install the Control Unit on a Medical Rail or IV pole CAUTION: Obey these mounting structure cautions to help prevent equipment damage: Caution—Make sure the diameter of the pole for mounting the pole clamp assembly is between 16 and 35 mm. Caution—Make sure the dimension of the medical rail 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 98. 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 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. Volara System Instructions for Use (196654 REV 8) 79 Accessories 80 Volara System Instructions for Use (196654 REV 8)  Replacement Parts and Kits REPLACEMENT PARTS AND KITS CONTROL UNIT PARTS Description Part number Battery compartment cover 194779 Foam kit, air inlet filter 203923S Foam kit, nebulizer filter 202909S Fuse, 4 A 250 V 207914 Patient circuit hook kit 203042S Therapy port cap 196680 Power Cord, 3 m (10') 181995 PATIENT CIRCUITS Description Part number Single Patient Use Circuit for Volara therapy M08268 Optional Parts Description Part number Face mask: 15 mm OD—infant 188339 Face mask: 22 mm ID—adult large 188343 Face mask: 22 mm ID—adult medium 188342 Face mask: 22 mm ID—adult small 188341 Face mask: 22 mm ID—child 188340 Face mask: 22 mm ID—adult, regular, inflatable 183158 Blue ventilator adapter Adapter, in-line, 22 mm/15F-15F M07937 Handset plug (for connection without a nebulizer kit) Oxygen bleed-in adapter 206704 Flexible tracheostomy adapter 206707 Pole Clamp Assembly M08235 Stand and Cart Assembly (with Pole Clamp). See M08177 page 75. Volara System Instructions for Use (196654 REV 8) 81 Cleaning and Disinfecting CLEANING AND DISINFECTING CAUTION: Caution—Use only Environmental Protection Agency (EPA) registered chemicals for the cleaning or disinfection of the Volara System (US only). CLEAN THE CONTROL UNIT AND STAND WARNING: Warning—Failure to disconnect the unit from its power source during cleaning could cause injury or equipment damage. CAUTION: To help prevent equipment damage, obey these cautions: Caution—Do not use harsh cleansers, solvents, or detergents. Caution—Do not steam or spray clean the unit. Pressure and excessive moisture could damage the product and its electrical components. 1. Clean the control unit, stand, and foot switch between therapy sessions, when visibly soiled, or according to facility protocols. 2. Power off the control unit and unplug it from its power source. 3. Disconnect any accessories attached to the control unit. 4. Disconnect the patient circuit from the control unit and put the therapy port cap over the therapy port. 5. Thoroughly wipe down the parts with a clean cloth dampened in a compatible bactericidal cleaning solution or compatible disinfectant wipes until no visible soil remains. 6. When using between multiple patients, disinfect the control unit by ensuring that all surfaces remain wetted with the disinfectant for the contact time specified below. 7. Allow the parts to dry completely before use. 82 Volara System Instructions for Use (196654 REV 8)  Cleaning and Disinfecting Compatible Cleaning and Disinfecting Solutions Contact Chemical Class Active Ingredient Time Phenolic Ortho-Phenylphenol 10 min Ortho-Benzyl-para-Chlorophenol Alcohol Isopropyl alcohol 5 min Quaternary Didecyl dimethyl ammonium 10 min ammonium chloride chloride Alkyl dimethyl benzyl ammonium chloride Alcohol/ Diisobutylphenoxyethoxyethyl 3 min Quaternary Dimethyl Benzyl Ammonium ammonium Chloride chloride Isopropanol CLEAN THE SINGLE PATIENT USE CIRCUIT—INSTITUTIONAL AND HOSPITAL USE WARNING: To help prevent patient infection and/or equipment damage, obey these warnings: Warning—Replace the circuit and the Smart-Filter between patients. Warning—If the Smart-Filter is damaged, visibly soiled or wet, replace it. For typical examples of soiled and damaged Smart-Filters™, see page 85. Warning—Make sure that the circuit is not used on more than one patient. Warning—Do not soak or wash the Smart-Filter. 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. Always keep the Smart-Filter dry and clean. Volara System Instructions for Use (196654 REV 8) 83 Cleaning and Disinfecting CLEAN THE SINGLE PATIENT USE CIRCUIT—HOME USE WARNING: To help prevent patient