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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 USER MANUAL The Vest Airway ® Clearance System, Model 205 From Hill-Rom Product No. P205 140643 REV 7...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11...
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Hill-Rom Services, Inc. (Hill-Rom). The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Hill-Rom. Seventh Edition First Printing 2006 Printed in the USA 3M®...
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Wex-Cide™ is a trademark of Wexford Labs, Inc. The information contained in this manual is subject to change without notice. Hill-Rom makes no commitment to update or keep current, the information contained in this manual. Hill-Rom reserves the right to make changes without notice in design, specifications, and models.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Table of Contents Document Symbols ........1 Precautions .
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Disable the Program Modes (Program and Ramp) ..25 Set Facility Custom Default Settings ....26 Use The Vest® Airway Clearance System, version 1.22 ..30 Normal Mode .
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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. • NOTE:—sets apart special data or important instruction clarification.
• Only authorized persons should service the unit. • If service is necessary, call Hill-Rom Technical Support. For contact information, refer to the back cover. For countries not listed on the back cover, contact your distributor.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 • When you use Dispatch® disinfectant or CSI disinfectant spray, make sure you wipe the unit dry. Failure to do so could result in the build-up of residue or equipment damage. • Do not eat or drink during a therapy session. To do so could cause a choking hazard.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Intended Use The Vest Airway Clearance System, Model 205 was developed to ® provide effective Airway Clearance Therapy. The system consists of a disposable garment attached to an Air Pulse Generator that rapidly inflates and deflates the disposable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Relative Contraindications If the patient has one or more of the conditions below, carefully consider and assess the patient’s case before you decide to use The Vest Airway ® Clearance System, Model 205. • Intracranial pressure (ICP) >20 mm Hg, or patients in whom increased intracranial pressure is to be avoided •...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Features Alternate Stand Air Pulse Generator Stand Push Bar Storage Basket Remote Control Air Hose Connector Ports Height Adjustment Release Air Hoses Lever Four Locking Casters Control Panel Air Pulse Generator When correctly connected, the Air Pulse Generator controls the disposable garment and supplies pulsations to the chest wall.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Remote Control Can be used instead of the ON/OFF button to pause or resume the Air Pulse Generator. Height Adjustment Release Lever Used to raise or lower the Air Pulse Generator to a comfortable working height.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Assembly Align the two posts on the rubber mat with the holes in the top of the stand. Align the holes on the bottom of the Air Pulse Generator with the posts on the rubber mat. NOTE: The screen on the Air Pulse Generator faces the side of the stand that the...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Instructions for Use Put on the Disposable, Single-Patient Use (SPU) Vests NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment. Wrap SPU Vest Turn the patient towards you. With the Wrap SPU Vest deflated, begin to lay it flat on the bed so it is perpendicular...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Full SPU Vest NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment. Separate the front flaps of the Full SPU Vest at the Velcro® fasteners. Turn the Full SPU Vest so the front flaps will meet in front of the patient.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Connect the Air Hoses to the disposable garment: For a Wrap SPU Vest, do as follows: Remove the tear label from the disposable garment. Slide the other end of each Air Hose into the disposable garment Air Hose slits at least 2"...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Set Up the Air Pulse Generator Install the Remote Control into the Air Pulse Generator. NOTE: Use of the Remote Control is optional. Plug the Power Cord into the power inlet on the back of the Air Pulse Generator.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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. Then it will show the model number and the total therapy hours for the unit.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 NOTE: It is not necessary to stop the treatment to adjust the settings. NOTE: If the backlight turns itself OFF, press any button to turn it back ON. Press the ON button. The disposable garment will inflate. NOTE: If the unit is left in this mode for 10 minutes, it...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 When the OFF button is pressed, the disposable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press ON to continue to the main screen. When the treatment session is complete: The “Session Complete”...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 For Programming Point 1, if the settings match the prescribed treatment, continue to step 3. Otherwise, adjust the settings to match the prescription by pressing the Up and Down arrows associated with Frequency, Pressure and treatment Time. Once you have Programming Point 1, proceed to...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 If it is necessary to pause the treatment during a session, do as follows: Press the OFF button or Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Using the Program Mode Allows the caregiver the capability to use a previously created New Program Mode, see “Setting and Using a New Program Mode” on page Press the Up arrow above PGM to run the previously created program, or selected default program.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 If it is necessary to end the treatment session before it is complete, press the OFF button. NOTE: Pressing the OFF button does not turn off the screen. When the OFF button is pressed, the disposable garment deflates and the “Incomplete X Min...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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 arrows.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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. This screen shows the summary of the ramp program you have just created.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 To resume treatment, press the ON button or the Remote Control again. 11. If it is necessary to end the treatment session before it is complete, press the OFF button. NOTE: Pressing the OFF button does not turn off the screen. 12.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Using the Ramp Mode Allows the caregiver to run a previously created Ramp Program, see “Set and Use the New Ramp Mode” on page 40. Press the Up arrow above RAMP to run the previously created ramp program.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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. NOTE: Pressing the OFF button does not turn off the screen. When the OFF button is pressed, the disposable garment...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Press the two outside Down arrow buttons for a minimum of 3 seconds (or until the screen changes). Press the Down arrow button below Spanish (it will turn Spanish to SPANISH). To accept the change, press the Down arrow button below ACEPTAR...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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 the word...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Press the left Up arrow button above Defaults. Press the right Up arrow button above default (default will change to DEFAULT). 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...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 10. Press the ON button to advance to the next default setting. 11. 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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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 15. Once you have accepted the change, it will automatically re- boot the system and go back to the main screen. 16. To switch back to previous patient default mode, repeat the steps and select prev pt instead of default.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Use The Vest Airway Clearance System, software ® version 1.22 Make sure the unit is set up correctly. Once power is connected, the unit will show a blank screen for up to 15 seconds. Then it will show the model number, the total therapy hours for the unit, and software revision.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed treatment Pressure shows on the screen. The Pressure may be set between 1 and 10. To adjust the treatment Time, press the right Up or Down arrow buttons until the prescribed treatment Time shows on the screen.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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. When the OFF button is pressed twice, the disposable garment...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 NOTE: All the settings can be adjusted. NOTE: You can program up to 8 different Programming Points, each with its own combination of Frequency, Pressure and treatment Time. WARNING: Consult your physician before you change the prescribed settings.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Press the Up or Down arrow for Cough Pause Reminder duration (time between cough pauses). A zero (0) time will turn off the Cough Pause® feature. Press On to go to the next screen. Press the Up or Down arrow to select the pause duration.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 10. Press the ON button. The disposable garment will inflate. 11. 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. 12.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Press the OFF button or 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 disposable garment will deflate. To resume treatment, press the ON button or...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 21. When the OFF button is pressed twice, the disposable garment deflates and the “Incomplete X Min Remain” message shows on the screen. You must press the ON button to continue to the Program and Ramp main screen.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Press the UP arrow button above CUSTOM. Press the Up arrow button above PGM A or PGM B to run the previously created program, or selected default program. Press the ON button. The disposable garment will inflate. Press the ON button again to begin the treatment program.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 To resume treatment, press the ON button or the Remote Control again. When the time for a cough pause is reached, these will happen: The unit will pause. The display will change to show the pause duration timer.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 The “Session Complete” message shows. The pulsations stop. The disposable garment deflates. 15. Unplug the system from its power source. 16. Remove the Air Hoses from the Air Hose Ports on the disposable garment. 17. Remove the disposable garment. Set and Use the New Ramp Mode Creates a new Ramp Program to ease the patient from a lower setting to a higher setting during a limited...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 To adjust the Pressure setting, press the middle Up or Down arrow buttons until the prescribed setting shows on the screen. Pressure may be set between the Ramp Start setting and 10. To adjust the treatment Time, press the right Up or Down arrow...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 To resume treatment, press the ON button or the Remote Control again. 13. 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. 14.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 WARNING: Consult your physician if not using the prescription as provided. Failure to do so can result in personal injury. Press the ON button. Press the UP arrow button above Custom. Press the Up arrow button above RAMP to run the previously created ramp...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 If it is necessary to pause the treatment during a session, do as follows: Press the OFF button or Remote Control once. The unit will stop the pulsations, but the settings will continue to show on the screen.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 11. Unplug the system from its power source. 12. Remove the Air Hoses from the Air Hose Ports on the disposable garment. 13. Remove the disposable garment. Change the Language Press the ON button. Press the Up arrow button above NORMAL.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Disable the Program Modes (Program and Ramp 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.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 To accept all changes and exit out of the menu, press the right Down arrow button below ACCEPT. 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.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Press the right Up arrow button above default (Defaults will change to DEFAULTS). 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...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 10. Press the Up or Down arrow for Cough Pause Reminder duration (time between cough pauses). A zero (0) time will turn off the Cough Pause® feature. 11. Press On to go to the next screen. 12.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 18. Adjust the Ramp Time Percent for the Default Ramp mode using the right Up and Down arrow buttons, and press the ON button. 19. Adjust the Ramp Start Frequency, and Pressure settings for default Ramp Mode by using the left and middle Up and Down arrow buttons, and...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Move the Air Pulse Generator Unplug the Air Pulse Generator from its power source. Stow the Power Cord on the holder on the back of the stand. CAUTION: Failure to lower the Air Pulse Generator to the lowest position could cause it to tip over during transport.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Raise or Lower the Air Pulse Generator Hold the Height Adjustment Release Lever on the side of the stand. Pull the Height Adjustment Release Lever upwards toward to the shelf. Push down, or pull up on the shelf, to adjust the height.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Cleaning WARNING: Follow the product manufacturer’s instructions. Failure to do so could cause personal injury or equipment damage. SHOCK HAZARD: Unplug the unit from its power source before you clean it. Failure to do so could cause personal injury or equipment damage. SHOCK HAZARD: Do not expose the unit to excessive moisture.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 General Cleaning WARNING: To help prevent cross-contamination, replace the single-patient use disposable garment between patients. Failure to do so could cause patient injury or equipment damage. NOTE: The disposable garments are single-patient use, latex-free, disposable products for use on individual patients over multiple treatment sessions.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Use the disinfectant as specified in the disinfectant manufacturer's instructions. Do not attempt to disinfect or sterilize the disposable garment for reuse with more than one patient. Maintenance WARNING: Only authorized persons should service The Vest Airway ®...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Disposable Garments and Replacement Parts Single-Patient Use, Disposable Wrap SPU Vest Part Number Description P300629005 X-Small package of 5 (19" to 23" (48 cm to 58 cm)) P300630005 Small package of 5 (>23" to 33" (58 cm to 84 cm)) P300631005 Medium package of 5 (>33"...
Model 205, call Hill-Rom Technical Support at 800-445-3720. If outside the US, refer to the back cover for contact information. When you contact Hill-Rom, be prepared to give the serial number from the product identification label. The product identification label is on the rear panel of the Air Pulse Generator.
Make sure the Power Cord is fully plugged into a known-good outlet. If the problem is not corrected, call Hill-Rom Technical Support. For contact information, refer to the back cover. No Air Pulses into the Disposable Garments If the Remote Control is in use, make sure it is firmly connected to the front panel of the Air Pulse Generator.
Connect the Air Hoses to the Air Pulse Generator and disposable garment (see “Set Up the Air Pulse Generator” on page 12). If the problem is not corrected, call Hill-Rom Technical Support. For contact information, refer to the back cover.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Product Symbols Symbol Definition Type B equipment with an F-type applied part, according to EN 60601-1. Dangerous voltage within the device may constitute a risk of electrical shock. ON button—starts the Air Pulse Generator (starts therapy, inflates the disposable gar- ment, moves to the next screen during pro- gramming, starts the unit after being paused) OFF button—stops the Air Pulse Generator...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Symbol Definition 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. Class II equipment (double insulated), according to EN 60601-1 IPX 0 Not protected against water ingress Medical Equipment with respect to electric...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Symbol Definition The Vest Airway Clearance System, Model ® 205 conforms to the European Medical Device Directive 93/42/EEC. Units made before May 2, 2008. The Vest Airway Clearance System, Model ® 205 conforms to the European Medical Device Directive 93/42/EEC.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 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) Stand weight 65 lb (29 kg) Alternate stand weight 32 lb (14.5 kg) Stand height—lowest position...
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Classification and Standards Technical and Quality Assurance UL/EN/IEC 60601-1 CAN/CSA C22.2 No. 601.1 ISO 13485 Equipment Classification Class II Degree of Protection Against Electric Shock BF with type F applied part Classification According to Directive 93/42/EEC Degree of Protection Against Ingress of IPX 0...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Guidance and Manufacturer’s Declaration— Electromagnetic Immunity The Vest Airway Clearance System, Model 205 is intended for use in the electromagnetic ® environment specified below. The customer or user of the Model 205 should make sure it is used in such an environment.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Guidance and Manufacturer’s Declaration— Electromagnetic Immunity The Vest Airway Clearance System, Model 205 is intended for use in the electromagnetic ® environment specified below. The customer or user of the Model 205 should make sure it is used in such an environment.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 The Vest Airway Clearance System, Model 205 is intended for use in the electromagnetic ® environment specified below. The customer or user of the Model 205 should make sure it is used in such an environment. Immunity IEC 60601 Compliance...
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Model 205 The Vest Airway Clearance System, Model 205 is intended for use in an electromagnetic ® environment in which radiated RF disturbances are controlled. The customer or user of the Model 205 can help prevent electromagnetic interference if they maintain the minimum distance between portable and mobile RF communications equipment (transmitters) and the Model 205.
PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 Frequently Asked Questions • Is The Vest Airway Clearance System as effective as chest ® physiotherapy (CPT)? – Research has shown that the system is nearly three times as effective as the use of chest physiotherapy to move airway secretions.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 • What will happen if a patient’s treatment session is skipped? – One missed treatment session of the system may or may not immediately impact the patient’s health. However, the key to help maintain the patient’s health is consistent, effective therapy.
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PROPRIETARY AND CONFIDENTIAL DRAFT 19-DEC-11 The Vest Airway Clearance System, Model 205 ® User Manual (140643 REV 7)
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Fax: +81 (0)3 5715 3425 Nederland New Zealand Nordic Region: Hill-Rom Medical Services BV c/o Hill-Rom Australia Pty. Ltd. Sverige, Denmark, Norge Tel: +31 (0)347 / 32 35 32 Tel: 61 (0)2 8814 3000 Hill-Rom AB Fax: +31 (0)347 / 32 35 00...
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