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3M™ is a trademark of 3M Company. C3® and The Vest® are registered trademarks of Hill-Rom Services PTE Ltd. Hillrom™ is a trademark of Hill-Rom Services, Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc. Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories, Inc.
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Table of Contents Revision ............i Intended Use .
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Table of Contents Use the Ramp Mode......... 38 Check the Hour Meter Reading .
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Table of Contents Shipping the Unit..........74 Specifications .
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Table of Contents NOTES: The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21)
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Intended Use INTENDED USE The Vest® Airway Clearance System, Model 105 was developed to provide effective Airway Clearance Therapy. The system consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs.
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Introduction NDICATIONS FOR USE The Vest® Airway Clearance System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician’s choice of treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy.
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Symbols SYMBOLS OCUMENT YMBOLS This manual contains different typefaces and symbols to make the content easier to read and understand: • Standard text—used for regular information. • Boldface text—emphasizes a word or phrase. • NOTE:—sets apart special data or important instruction clarification. •...
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Symbols Symbol Definition Frequency setting Pressure setting Time setting Up arrow button—increases the Frequency, Pressure, or Time setting. Down arrow button—decreases the Frequency, Pressure, or Time setting. Remote Control port Attention: Consult accompanying documents. (Applicable to UL60601-1 compliant units.) Class II equipment (double insulated), according to EN60601-1.
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Symbols Symbol Definition Medical— General Medical Equipment as to Electrical Shock, Fire, and Mechanical Hazards Only in Accordance with: ANSI/AAMI ES60601-1(2005) +AMD (2012) CAN/CSA-C22.2 No. 60601-1:14 E336914 Devices with serial numbers 61-XXXXX and 62-XXXXX are in compliance with these standards: Medical Equipment with respect to electrical shock, fire, mechanical, and other specified hazards only in accordance with UL/EN/IEC...
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Symbols Symbol Definition No chlorine bleach. Tumble dry. Bladder removal procedure (child small through adult sizes). Bladder installation procedure (child extra small size). Catalog number Batch number Serial number Medical Device The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21)
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Symbols Symbol Definition Authorized Representative in the European Community Unique Device Identification 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.
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Symbols Symbol Definition Manufacturer and date of manufacture Non sterile For multiple use on a single patient Physician prescription required (for US only). (Only for products to the Federative Republic of Brazil) InMetro Net Connection Corporation (NCC) logo Tear open here (Only for products to the People's Republic of China) China RoHS2 (Standard No SJ/T 11364-2014)
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Safety Instructions SAFETY INSTRUCTIONS ONTRAINDICATIONS WARNING: Warning—If the patient conditions exist that cause the use of The Vest® Airway Clearance System to present a risk to the patient, do not use the unit except as directed by a physician. Death or serious injury could occur.
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Safety Instructions • Recent placement of transvenous or subcutaneous pacemaker • Suspected pulmonary tuberculosis • Lung contusion • Bronchospasm • Osteoporosis or osteomyelitis of the ribs • Coagulopathy • Complaint of chest wall pain READ ALL INSTRUCTIONS BEFORE USING NOTE: When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following important safeguards.
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Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: • 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.
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Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: • Warning—Only authorized personnel should service The Vest® Airway Clearance System. Servicing by unauthorized personnel could cause personal injury or equipment damage. NOTE: If service is necessary, use this contact information: –...
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Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: • Warning—Do not run the Air Pulse Generator without the inflatable garment and Air Hoses attached. •...
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Safety Instructions WARNING: (Warnings continued) Obey all warnings throughout the manual and also the safety information below to help prevent injury and/or equipment damage: • Warning—Some patients may experience nausea, dizziness or headache when using the therapy. It is recommended that patients refrain from doing any therapy for a period of time after eating.
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Features FEATURES Air Pulse Generator Air Pulse Generator Remote Control Air Hose Connection Ports Control Panel Air Hoses When correctly connected, the Air Pulse Generator controls the inflatable garment and supplies pulsations to the chest wall. ONTROL ANEL Pressing the ON or OFF controls or the 6 Up and Down arrow buttons, activates or deactivates features/functions...
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Features ONNECTOR ORTS The Air Hoses connect to the Air Pulse Generator at the two Air Hose Connector Ports on the face of the Air Pulse Generator. OSES The Air Hoses connect the inflatable garment to the Air Pulse Generator. NON LOCKING LOCKING EMOTE...
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Features NFLATABLE ARMENT The garment that you have will look like one of these: • Chest Vest • Full Vest • Wrap Vest Chest When connected to the Air Pulse Generator by the Air Hoses, the inflatable garment is controlled by the Air Pulse Generator to provide pulsations to the chest wall.
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Instructions for Use INSTRUCTIONS FOR USE WARNING: Warning—Changing prescribed settings, an unadjusted or ill-fitting garment may cause an ineffective therapy or lead to patient injury. Protocol for Use and Special Instructions Your physician has prescribed The Vest® Airway Clearance System to be used __________ times per day.
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Instructions for Use ETTING P THE Inspect the Air Pulse Generator and Garments before each use. In addition, after each cleaning cycle, visually inspect each component for any wear, tear, or deformity. If you have any concern about a component, do not use it, and replace that component before the next therapy session.
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Instructions for Use NOTE: Once the unit is plugged in or the ON button is pressed, the following will show on the screen: The Model number. The total number of hours the device has been used. The software revision. NOTE: To temporarily illuminate the backlight on the display, press any one of the six Up or Down arrow buttons.
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Instructions for Use NOTE: The contour foam is not sterile. Cut out a center hole to form a “donut” shape in the foam. Put the open hole of the “donut” directly over the port site. Fit the inflatable garment: NOTE: The Vest®...
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Instructions for Use Connect the Air Hoses to the ports on the inflatable garment. Slightly twist the Air Hoses into the Air Hose Connector Ports to help secure the Air Hoses in position. NOTE: The connection of the Air Hoses to the Ports is the same for the locking and the non-locking hoses.
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Instructions for Use Adjust the hook-and-loop fasteners on the shoulder straps so the bottom of each arm opening of the Chest Vest is comfortably close to the underarm. Detach both back panel tabs from the front of the Chest Vest. For the best fit, inhale deeply, and then secure both back panel tabs to the front panel.
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Instructions for Use Close the zipper on the bottom of the outer garment. To assemble the Child Extra Small Size: Lay the outer garment flat. Open the flap on the bottom of the outer garment. Put the inflatable bladder into the outer garment.
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Instructions for Use Using the front closures, adjust the garment to fit close to the body without being uncomfortably snug: • To tighten the front closures, hold the buckle, and pull the end of the strap to the patient’s right. •...
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Instructions for Use Adjust the garment to fit close to the body without being uncomfortably snug: • To tighten the fit at the bottom edge, angle the front panel tabs upward. • To loosen the fit at the bottom edge, angle the front panel tabs downward.
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Software Version SOFTWARE VERSION The software version is displayed on the start screen when the unit is connected to AC power. Software Version Instructions 1.20 X.XX is the software version; (XX) is the software revision. Go to “Use The Vest® Airway Clearance System, Software Version 1.20”...
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Use The Vest® Airway Clearance System, Software Version 1.20 USE THE VEST® AIRWAY CLEARANCE SYSTEM, SOFTWARE VERSION 1.20 Make sure the unit is set up correctly. Once power is connected, the unit will show a blank screen for up to 15 seconds.
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Use The Vest® Airway Clearance System, Software Version 1.20 Frequency or Hertz (Hz) may be set between 5 and 20 cycles per second. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen.
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Use The Vest® Airway Clearance System, Software Version 1.20 before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain”...
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Use The Vest® Airway Clearance System, Software Version 1.20 Press the UP arrow button above OPTIONS. Press the Down arrow button below New Pgm to create a new program. The screen will show the Frequency, Pressure, and treatment Time settings for the first Programming Point.
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Use The Vest® Airway Clearance System, Software Version 1.20 Therapy will automatically end after it has gone through each Programming Point. If it is necessary to pause the treatment during a session, do as follows: Press the OFF button or the Remote Control once.
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Use The Vest® Airway Clearance System, Software Version 1.20 12. When the treatment session is complete: The “Session Complete” message shows. The pulsations stop. The inflatable garment deflates. 13. Unplug the system from its power source. 14. Remove the Air Hoses from the Air Hose Ports on the inflatable garment.
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Use The Vest® Airway Clearance System, Software Version 1.20 Press the ON button again to begin the treatment program. The set treatment Time shows as it counts down to zero for each Programming Point. The therapy will automatically end after it has gone through each of the Programming Points.
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Use The Vest® Airway Clearance System, Software Version 1.20 press the ON button to continue to the Program and Ramp main screen. 10. When the treatment session is complete: The “Session Complete” message shows. The pulsations stop. The inflatable garment deflates. 11.
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Use The Vest® Airway Clearance System, Software Version 1.20 Look at the settings on the screen. Ramp Time Percent is the portion of the treatment Time required to increase from the initial settings (Ramp Start) to the final settings (Ramp End). To adjust the percent to the prescribed therapy, press the right Up or Down arrow buttons.
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Use The Vest® Airway Clearance System, Software Version 1.20 To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen. The treatment Time may be set between 1 and 60 minutes. Press the ON button to advance to the next screen.
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Use The Vest® Airway Clearance System, Software Version 1.20 NOTE: Pressing the OFF button does not turn off the screen. 14. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain” message shows on the screen.
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Use The Vest® Airway Clearance System, Software Version 1.20 Press the UP arrow button above OPTIONS. Press the Up arrow button above RAMP to run the previously created ramp program. The programmed points will be shown. Press the ON button to advance to the next screen.
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Use The Vest® Airway Clearance System, Software Version 1.20 To resume treatment, press the ON button or the Remote Control again. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen.
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Use The Vest® Airway Clearance System, Software Version 1.20 HANGE THE ANGUAGE Press the ON button. Press the Up arrow button above NORMAL. The Normal mode screen shows. Press the two -outside Down arrow buttons at the same time for a minimum of 3 seconds (or until the screen changes).
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Use The Vest® Airway Clearance System, Software Version 1.20 ISABLE THE ROGRAM ODES ROGRAM AND AMP MODES Disable the Program modes allows the unit to operate in Normal mode only, and removes access to custom modes by the user. Press the ON button. Press the left Up arrow button above NORMAL.
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Use The Vest® Airway Clearance System, Software Version 1.20 Once you have accepted the change, the system will automatically re- boot and go to the main screen of NORMAL mode. You will no longer be able to see the Program or Ramp mode programs. To switch back to Program mode, repeat the steps starting at step 2.
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Use The Vest® Airway Clearance System, Software Version 1.20 To accept the change, press the right Down arrow button below ACCEPT. To adjust the Maximum Run Time use the Up and Down arrow buttons above and below MIN and then press the ON button. To set default Frequency, Pressure, and Time settings for Normal mode,...
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Use The Vest® Airway Clearance System, Software Version 1.20 12. Adjust the Ramp Time Percent for the Default Ramp mode using the right Up and Down arrow buttons, and press the ON button. 13. Adjust the Ramp Start Frequency, and Pressure settings for default Ramp mode by using the left and middle Up and Down...
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher USE THE VEST® AIRWAY CLEARANCE SYSTEM, SOFTWARE VERSION 1.22 OR 2.00 AND HIGHER Make sure the unit is set up correctly. Once power is connected, the unit will show a blank screen for up to 15 seconds.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Frequency or Hertz (Hz) may be set between 5 and 20 cycles per second. To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher To resume treatment, press the ON button or the Remote Control again. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher WARNING: Warning—Consult your physician prior to changing prescribed settings. Failure to do so can cause personal injury. Press the ON button. Press the UP arrow button above CUSTOM. Do one of these: To program the Ramp mode, press the...
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Press the Up or Down arrow to select the pause duration. This will set the duration the unit pauses for coughs. Press On to go to the next screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Press the OFF button or the Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen. NOTE: When the unit is paused, the inflatable garment will deflate. To resume treatment, press the ON button or the Remote Control...
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher press the ON button to continue to the Program and Ramp main screen. 19. When the treatment session is complete: The “Session Complete” message shows. The pulsations stop. The inflatable garment deflates.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Press the ON button. The inflatable garment will inflate. Press the ON button again to begin the treatment program. The set treatment Time shows as it counts down to zero for each Programming Point.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher To resume treatment, press the ON button or the Remote Control again. 12. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 17. When the treatment session is complete: The “Session Complete” message shows. The pulsations stop. The inflatable garment deflates. d. Unplug the system from its power source. Remove the Air Hoses from the Air Hose Ports on the inflatable garment.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Look at the settings on the screen. Ramp Time Percent is the portion of the treatment Time required to increase from the initial settings (Ramp Start) to the final settings (Ramp End).
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen. The treatment Time may be set between 1 and 60 minutes. Press the ON button to advance to the next screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher NOTE: Pressing the OFF button does not turn off the screen. 14. When the OFF button is pressed twice, the inflatable garment deflates and the “Incomplete X Min Remain”...
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Press the UP arrow button above Custom. Press the Up arrow button above RAMP to run the previously created ramp program. The programmed points will be shown. Press the ON button to advance to the next screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher To resume treatment, press the ON button or the Remote Control again. If it is necessary to end the treatment session before it is complete, press the OFF button twice. NOTE: Pressing the OFF button does not turn off the screen.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher HECK THE ETER EADING The Hour Meter Reading will show on the screen when you first plug your device in. You can also access the Hour Meter Reading as follows: •...
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher To accept the change, press the far right Down arrow button. Once you have accepted the change, the system will automatically re-boot and go back to the main screen in the applicable language.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Press the right Up arrow button above pgm disable (it will turn to PGM DISABLE). To accept the change, press the right Down arrow below ACCEPT. To accept all changes and exit out of the menu, press the right Down arrow button below...
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher Press the two outside Down arrows for a minimum of 3 seconds, or until the screen changes. Press the left Up arrow button above Defaults. Press the right Up arrow button above default (Defaults will change to DEFAULTS).
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher To set default Frequency, Pressure, and Time settings for Normal mode, adjust each by using the respective Up and Down arrow buttons, press the ON button and return to step 8.
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Use The Vest® Airway Clearance System, Software Version 1.22 or 2.00 and higher 17. Press the ON button to advance to the next default setting, and return to step 8. 18. Adjust the Ramp Time Percent for the Default Ramp mode using the right Up and Down arrow buttons, and press the ON button.
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Cleaning CLEANING WARNING: When you clean and disinfect the device, follow these safety instructions; otherwise, personal injury or equipment damage could occur: • Warning—The potential for electrical shock exists with electrical equipment. Failure to follow facility protocols may cause death or serious injury.
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Cleaning —A ENERAL LEANING ULSE ENERATOR AND LASSIC ARMENT NOTE: The non-washable garments are referred to as the Classic Line, and the washable garments are referred to as the C3® Garment Line. We recommend that you wipe clean the Air Pulse Generator and inflatable garment with detergent and warm water.
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Cleaning C3® G ARMENT LEANING Only the outer piece of the C3® Garment Line can be machine washed. The bladder is cleaned in the same manner as the Classic garment above. Remove the bladder assembly as follows: Open up the buckles or hook and loop connections and lay the garment flat on a table.
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Maintenance MAINTENANCE WARNING: Warning—Only authorized personnel should service The Vest® Airway Clearance System. Servicing by unauthorized personnel could cause personal injury or equipment damage. The Vest® Airway Clearance System requires minimal routine maintenance. Periodic cleaning is required (see “Cleaning” on page 67). If service is necessary, use this contact information: •...
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Expected Life EXPECTED LIFE The expected service life for the air pulse generator is two years from date of purchase. The expected service life of the hoses and the remote control is thirty days from date of purchase. Hill-Rom will repair or replace a defective unit as part of a warranty package specified at the time of purchase of the device, which may extend beyond the expected service life specified above based on servicing and warranty costs.
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Troubleshooting TROUBLESHOOTING WARNING: Warning—Only authorized personnel should service The Vest® Airway Clearance System, Model 105. Servicing by unauthorized personnel could cause personal injury or equipment damage. Do not modify this device without the authorization of the manufacturer. To do so could cause personal injury or equipment damage.
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Troubleshooting “P ” M CREEN HOWS LEASE ALL FOR ERVICE ESSAGE The system has experienced an unexpected event. Do as follows: Unplug the Power Cord from the Air Pulse Generator, and then plug it in again. If the problem is not corrected, contact Hill-Rom. OMES OUT OF THE ULSE ENERATOR OR...
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Storage and Handling STORAGE AND HANDLING To store or transport The Vest® Airway Clearance System, do as follows: Put the Air Pulse Generator in the roller bag. Put the Air Hoses in either of the end compartments. Put the inflatable garment in the other end compartment along with the Remote Control and Power Cord.
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Specifications SPECIFICATIONS Feature Dimension Air Pulse Generator weight 17 lb (8 kg) Air Pulse Generator height 9.5" (24.1 cm) Air Pulse Generator width 13" (33 cm) Air Pulse Generator depth 9.5" (24.1 cm) Inflatable garment Polyvinyl chloride (PVC)-coated material—Chest polyester with polyurethane-coated nylon Inflatable garment Polyurethane-coated nylon...
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Specifications Classification and Standards Classification Standards Technical and Quality ANSI/AAMI ES60601-1 Assurance—Devices with serial ANSI/AAMI HA60601-1-11 numbers CAN/CSA-C22.2 No. 60601-1 63-XXXXX, 64-XXXXX, and CAN/CSA-C22.2 No. 60601-1-11 65-XXXXX IEC/EN 60601-1 IEC/EN 60601-1-6 IEC/EN 60601-1-11 IEC/EN 62366-1 EN ISO 13485 Technical and Quality UL/EN/IEC 60601-1 Assurance—Devices with serial CAN/CSA C22.2 No.
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Specifications LECTROMAGNETIC OMPATIBILITY UIDANCE The Vest® Airway Clearance System, Model 105 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. WARNING: To help prevent injury and/or equipment damage, obey these warnings: •...
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Specifications Guidance and Manufacturer’s Declaration— Electromagnetic Emissions The Vest® Airway Clearance System, Model 105 is intended for use in the electromagnetic environment specified below. The customer or user of the Model 105 should make sure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment—Guidance...
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Specifications Guidance and Manufacturer’s Declaration— Electromagnetic Immunity The Vest® Airway Clearance System, Model 105 is intended for use in the electromagnetic environment specified below. The customer or user of the Model 105 should make sure it is used in such an environment. Immunity IEC 60601 Compliance...
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Specifications Guidance and Manufacturer’s Declaration— Electromagnetic Immunity The Vest® Airway Clearance System, Model 105 is intended for use in the electromagnetic environment specified below. The customer or user of the Model 105 should make sure it is used in such an environment. Immunity IEC 60601 Compliance...
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Specifications Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and The Vest® Airway Clearance System, Model 105 The Vest® Airway Clearance System, Model 105 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of The Vest®...
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Specifications Guidance and Manufacturer’s Declaration— Electromagnetic Immunity to Wireless Communications Equipment The Vest® Airway Clearance System, Model 105 is intended for use in the electromagnetic environment specified below. The customer or user of the Model 105 should make sure it is used in such an environment.
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Frequently Asked Questions FREQUENTLY ASKED QUESTIONS • How does The Vest® Airway Clearance System effectively treat areas of my lungs? – The system is designed to oscillate the chest wall to create airflow by applying percussion to the lung area to treat the lobes of the lung.
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Frequently Asked Questions NOTES: The Vest® Airway Clearance System, Model 105 Instructions for Use (145330 REV 21)
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