Hillrom Vest 205 Instructions For Use Manual
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Hillrom Vest 205 Instructions For Use Manual

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The Vest® Airway Clearance
System, Model 205
Instructions for Use

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  • Page 1 The Vest® Airway Clearance System, Model 205 Instructions for Use...
  • Page 3 EVISION © 2020 by Hill-Rom Services PTE Ltd. ALL RIGHTS RESERVED. 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.
  • Page 4 3M™ is a trademark of 3M Company. Cough Pause® and Hill-Rom® are registered trademarks of Hill-Rom Services, Inc. Hillrom™ is a trademark of Hill-Rom Services, Inc. Underwriters Laboratories Inc.® is a registered trademark of Underwriters Laboratories Inc. The UL logo is a registered trademark of Underwriters Laboratories, Inc.

  • Page 5: Table Of Contents

    Table of Contents Revision ............i Intended Use .
  • Page 6 Table of Contents Using the Program Mode ........26 Setting and Using a New Ramp Mode .
  • Page 7 Table of Contents An Air Hose Comes out of the Air Pulse Generator or Disposable Garments during Operation ..... . 67 Screen Shows “RESTARTING”...
  • Page 8 Table of Contents NOTES: The Vest® Airway Clearance System, Model 205 Instructions for Use (140643 REV 16)

  • Page 9: Intended Use

    Intended Use 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.

  • Page 10: Symbols

    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 data. • Boldface text—emphasizes a word or phrase. • NOTE:—sets apart special data or important instruction clarification. •...
  • Page 11 Symbols Symbol Definition OFF button—stops the Air Pulse Generator (stops therapy, deflates the disposable garment, pauses therapy, moves to previous screen during programming). 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.
  • Page 12 Symbols Symbol Definition Read the operating instructions. 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 51-XXXXX and 52-XXXXX are in compliance with these standards: Medical Equipment with respect to electrical shock, fire, mechanical, and other specified hazards only in accordance with...
  • Page 13 Symbols Symbol Definition Catalog number Batch number Serial number Medical Device 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 The Vest®...
  • Page 14 Symbols Symbol Definition Stacking limit. The maximum number of identical packages which may be stacked on the bottom package. Date of manufacture Manufacturer 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...
  • Page 15 Symbols Symbol Definition Mass of equipment weight The Vest® Airway Clearance System, Model 205 Instructions for Use (140643 REV 16)

  • Page 16: Safety Instructions

    Safety Instructions SAFETY INSTRUCTIONS ONTRAINDICATIONS WARNING: Warning—If 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.
  • Page 17 Safety Instructions • Rib fractures, with or without flail chest • Surgical wound, healing tissue, recent skin grafts, or flaps on thorax • Burns, open wounds, and skin infections on the thorax • Lung contusion • Osteomyelitis of the ribs •...
  • Page 18 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 use unauthorized parts or accessories with this device. • Warning—Use only Hill-Rom authorized hoses and vests to avoid allergic skin reactions.
  • Page 19 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 eat or drink during a therapy session. • Warning—Do not leave the garment on a patient for extended periods of time without a cloth barrier between the patient and the garment.
  • Page 20 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.

  • Page 21: Features

    Features 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 ULSE ENERATOR When correctly connected, the Air Pulse Generator controls the disposable garment and supplies pulsations to the chest wall.

  • Page 22: Push Bar

    Features The Push Bar permits the unit to be moved around in a room or from room to room. EMOTE ONTROL The Remote Control can be used instead of the ON/OFF button to pause or resume the Air Pulse Generator. EIGHT DJUSTMENT ELEASE...

  • Page 23: Assembly

    Assembly 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 basket is on.

  • Page 24: Instructions For Use

    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. (SPU) V UT ON THE ISPOSABLE INGLE ATIENT ESTS NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment to prevent static charge build-up.

  • Page 25: Full Spu Vest

    Instructions for Use Full SPU Vest NOTE: It is recommended that a single layer of cotton clothing be worn beneath the disposable garment to prevent static charge build-up. Separate the front flaps of the Full SPU Vest at the hook-and-loop fasteners.
  • Page 26 Instructions for Use Install the foam as follows: 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. Connect the Air Hoses to the disposable garment.
  • Page 27 Instructions for Use Slide the other end of each Air Hose into the disposable garment Air Hose slits at least 2" (5 cm). Use the hook-and-loop loops on the side of the disposable garment to hold the Air Hoses in position. NOTE: The garment can be worn with the Air Hose Connector Ports...

  • Page 28: Set Up The Air Pulse Generator

    Instructions for Use P THE ULSE ENERATOR 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. Plug the Power Cord into an applicable power outlet.

  • Page 29: Software Version

    Software Version SOFTWARE VERSION The software version is displayed on the opening screen when the unit is connected to AC power. X.XX is the software version; (XX) is the software revision. Software Version Instructions 1.20 Go to “Use The Vest® Airway Clearance System, Software Version 1.20”...
  • Page 30 Use The Vest® Airway Clearance System, Software Version 1.20 To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed treatment shows on the screen. The 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.

  • Page 31: Setting And Using A New Program Mode

    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. NOTE: Pressing the OFF button does not turn off the screen. When the OFF button is pressed, the disposable garment deflates and the...
  • Page 32 Use The Vest® Airway Clearance System, Software Version 1.20 NOTE: All the settings can be adjusted. You can program up to 8 different Programming Points, each with its own combination of Frequency, Pressure, and treatment Time. For Programming Point 1, if the settings match the prescribed treatment, continue to step 3.
  • Page 33 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. The unit will stop the pulsations, but the settings will continue to show on the screen.

  • Page 34: Using The Program Mode

    Use The Vest® Airway Clearance System, Software Version 1.20 Remove the disposable garment from the patient. SING THE ROGRAM Allows the caregiver the capability to use a previously created New Program Mode, See “Setting and Using a New Program Mode” on page 23. Press the Up arrow above PGM to run the previously created...

  • Page 35: Setting And Using A New Ramp Mode

    Use The Vest® Airway Clearance System, Software Version 1.20 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 Remain” message shows on the screen. You must press ON to continue to the main screen.
  • Page 36 Use The Vest® Airway Clearance System, Software Version 1.20 Press the ON button to advance to the next screen. Review the settings for Frequency and Pressure for the initial setting, Ramp Start. To adjust the Frequency setting, press the left Up or Down arrow buttons until the prescribed treatment shows on the screen.
  • Page 37 Use The Vest® Airway Clearance System, Software Version 1.20 Press the ON button. The disposable garment will inflate. Press the ON button again to begin the therapy. The screen will show the word Ramping during the ramp portion of the program. The total treatment Time shows as it counts down to zero.

  • Page 38: Using The Ramp Mode

    Use The Vest® Airway Clearance System, Software Version 1.20 12. 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. 13.
  • Page 39 Use The Vest® Airway Clearance System, Software Version 1.20 Press the ON button again to begin the program. The screen will show the word Ramping during the ramp portion of the program. The total treatment Time shows as it counts down to zero. NOTE: Therapy settings cannot be changed during Ramping stage.

  • Page 40: Check The Hour Meter Reading

    Use The Vest® Airway Clearance System, Software Version 1.20 When the treatment session is complete: The “Session Complete” message shows. The pulsations stop. The disposable garment deflates. d. Immediately unplug the system from its power source. Remove the Air Hoses from the Air Hose Ports on the disposable garment.

  • Page 41: Disable The Program Modes (Program And Ramp)

    Use The Vest® Airway Clearance System, Software Version 1.20 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.

  • Page 42: Set Facility Custom Default Settings

    Use The Vest® Airway Clearance System, Software Version 1.20 To accept all changes and exit out of the menu, press the right Down arrow button below the word ACCEPT. Once you have accepted the change, the system will automatically re-boot and go to the main screen of NORMAL Mode.
  • Page 43 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 press the ON button. To set default Frequency, Pressure, and Time settings, for Normal...

  • Page 44: Use The Vest® Airway Clearance System, Software Version 1.22

    Use The Vest® Airway Clearance System, Software Version 1.22 12. Adjust the Ramp Start, Frequency, and Pressure settings for default Ramp Mode by using the left and middle Up and Down arrow buttons, and press the ON button. 13. Adjust the Ramp End settings for default Ramp Mode, Frequency, Pressure, and Time using...

  • Page 45: Normal Mode

    Use The Vest® Airway Clearance System, Software Version 1.22 ORMAL Normal Mode is using one Frequency, Pressure and Time settings for the entire therapy session. Press the Up arrow button above NORMAL for the standard operation mode. The screen will show the previously programmed Frequency, Pressure, and treatment Time settings...
  • Page 46 Use The Vest® Airway Clearance System, Software Version 1.22 Press the ON button. The disposable garment will inflate. NOTE: If the unit is left in this mode for 10 minutes, it will turn off. Press the ON button again to begin the treatment. The set treatment Time shows as it counts down to zero.

  • Page 47: Set And Use The New Program Mode

    Use The Vest® Airway Clearance System, Software Version 1.22 When the treatment session is complete: The “Session Complete” message shows. The pulsations stop. The disposable garment deflates. Unplug the system from its power source. 10. Remove the Air Hoses from the Air Hose Ports on the disposable garment.
  • Page 48 Use The Vest® Airway Clearance System, Software Version 1.22 Do one of these: To program the Ramp mode, press the Down arrow under RAMP NEW and See “Set and Use the New Ramp Mode” on page To program Program A or Program B, press the Down arrow button below PGM A NEW, or PGM B NEW...
  • Page 49 Use The Vest® Airway Clearance System, Software Version 1.22 Programming Point, press the OFF button). Adjust the settings to match the prescription and repeat for all 8 Programming Points. NOTE: If the prescription does not call for all 8 Programming Points, after programming the last prescribed programming point, set the Time to 0 MIN for the following segment.
  • Page 50 Use The Vest® Airway Clearance System, Software Version 1.22 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 disposable garment will deflate. To resume treatment, press the ON button or the Remote...

  • Page 51: Use The Program Mode

    Use The Vest® Airway Clearance System, Software Version 1.22 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. 22.
  • Page 52 Use The Vest® Airway Clearance System, Software Version 1.22 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.
  • Page 53 Use The Vest® Airway Clearance System, Software Version 1.22 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.

  • Page 54: Set And Use The New Ramp Mode

    Use The Vest® Airway Clearance System, Software Version 1.22 14. When the treatment session is complete: 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.
  • Page 55 Use The Vest® Airway Clearance System, Software Version 1.22 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.
  • Page 56 Use The Vest® Airway Clearance System, Software Version 1.22 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.

  • Page 57: Use The Ramp Mode

    Use The Vest® Airway Clearance System, Software Version 1.22 NOTE: Pressing the OFF button does not turn off the screen. 14. When the OFF button is pressed twice, the disposable garment deflates and the “Incomplete X Min Remain” message shows on the screen.
  • Page 58 Use The Vest® Airway Clearance System, Software Version 1.22 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.

  • Page 59: Check The Hour Meter Reading

    Use The Vest® Airway Clearance System, Software Version 1.22 NOTE: When the unit is paused, the disposable garment will deflate. 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.

  • Page 60: Change The Language

    Use The Vest® Airway Clearance System, Software Version 1.22 and then press the OFF button. The Hour Meter Reading will show on the screen. 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 for a minimum of 3 seconds (or...

  • Page 61: Disable The Program Modes (Program And Ramp Modes)

    Use The Vest® Airway Clearance System, Software Version 1.22 ISABLE THE ROGRAM ODES ROGRAM AND ODES 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.

  • Page 62: Set Custom Default Settings

    Use The Vest® Airway Clearance System, Software Version 1.22 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 3.
  • Page 63 Use The Vest® Airway Clearance System, Software Version 1.22 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.
  • Page 64 Use The Vest® Airway Clearance System, Software Version 1.22 12. Press the Up or Down arrow to select the pause duration. This will set the duration the unit pauses for coughs. 13. Press ON to go to the next screen. 14.

  • Page 65: Move The Air Pulse Generator

    Use The Vest® Airway Clearance System, Software Version 1.22 Up and Down arrow buttons, and press the ON button. 20. Adjust the Ramp End settings for default Ramp Mode Frequency, Pressure and Time settings using the Up and Down arrow buttons, and press the ON button and return to step 8.
  • Page 66 Use The Vest® Airway Clearance System, Software Version 1.22 Press down on the brake release to set the brakes on all four casters. Adjust the height of the Air Pulse Generator to the desired position. Plug the Air Pulse Generator into an applicable power outlet.

  • Page 67: Raise Or Lower The Air Pulse Generator

    Use The Vest® Airway Clearance System, Software Version 1.22 AISE OR OWER THE ULSE ENERATOR 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.

  • Page 68: Cleaning

    Cleaning CLEANING WARNING: 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.

  • Page 69: General Cleaning

    Cleaning ENERAL LEANING WARNING: 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. Clean The Vest®...

  • Page 70: Disinfecting

    Maintenance ISINFECTING When there is visible soil and between patient use, we recommend that you disinfect the unit with an intermediate level, tuberculocidal disinfectant. 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.

  • Page 71: Disposal Instructions

    Disposal Instructions DISPOSAL INSTRUCTIONS Users must adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hill-Rom Technical Support for guidance on safe disposal protocols.

  • Page 72: Disposable Garments And Replacement Parts

    Disposable Garments and Replacement Parts DISPOSABLE GARMENTS AND REPLACEMENT PARTS NOTE: The disposable vests and air hoses are not made with natural rubber latex. Single-Patient Use, Disposable Wrap SPU Vest Part Number Description P300629000 X-Small package of 1 (19" to 23" (48 cm to 58 cm)) P300630000 Small package of 1 (>23"...
  • Page 73 Disposable Garments and Replacement Parts Single-Patient Use, Disposable Full SPU Vest Part Number Description P300200000 Child Medium (23" to 27" (58 cm to 69 cm)) P300205000 Child Large (>27" to 31" (>69 cm to 79 cm)) P300208000 Adult, Extra Small, slim (>27"...

  • Page 74: Size The Disposable Garments

    Service Calls IZE THE ISPOSABLE ARMENTS To size the disposable garment, do as follows: Have the patient take a deep breath and hold it. Using a tape measure, loosely measure around the patient at the largest part of their chest. Women should be measured at the bust line.

  • Page 75: Air Pulse Generator Does Not Power On

    Troubleshooting ULSE ENERATOR OWER Make sure the Power Cord is fully plugged into the electrical inlet on the rear panel of the Air Pulse Generator. If necessary, unplug the Power Cord from the Air Pulse Generator, and then plug it in again. Make sure the Power Cord is fully plugged into a known-good outlet.

  • Page 76: Specifications

    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) Stand weight 35 lb (16 kg) Alternate stand weight 22 lb (10 kg) Stand height—lowest position 29"...

  • Page 77: Classification And Standards

    Specifications LASSIFICATION AND TANDARDS Technical and Quality Assurance ANSI/AAMI ES60601-1 ANSI/AAMI HA60601-1-11 CAN/CSA-C22.2 No. 60601-1 CAN/CSA-C22.2 No. 60601-1-11 IEC/EN 60601-1 IEC/EN 60601-1-6 IEC/EN 60601-1-11 IEC/EN 62366-1 EN ISO 13485 Technical and Quality Assurance— UL/EN/IEC 60601-1 Devices with serial numbers CAN/CSA C22.2 No. 601.1 51-XXXXX and 52-XXXXX EN ISO 13485 Equipment Classification...
  • Page 78 Specifications Guidance and Manufacturer’s Declaration— Electromagnetic Emissions 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. Emissions Test Compliance Electromagnetic Environment—Guidance...
  • Page 79 Specifications 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. Immunity IEC 60601 Compliance...
  • Page 80 Specifications 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. Immunity IEC 60601 Compliance...
  • Page 81 Specifications Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and The Vest® Airway Clearance System, 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 Vest®...
  • Page 82 Specifications Guidance and Manufacturer’s Declaration— Electromagnetic Immunity to Wireless Communications Equipment 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.

  • Page 83: Frequently Asked Questions

    Frequently Asked Questions FREQUENTLY ASKED QUESTIONS • How does The Vest® Airway Clearance System effectively treat areas of the 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.
  • Page 84 Frequently Asked Questions NOTES: The Vest® Airway Clearance System, Model 205 Instructions for Use (140643 REV 16)

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