USER MANUAL - The Vest® Airway Clearance System
Contents
1. 56 Shipping the Unit 56 Frequently Asked Questions 57 Specifications 4 nesso ene Pye 59 Regulations Codes and Standards 60 Page iv The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 DOCUMENT SYMBOLS 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 e NOTE sets apart special data or important instruction clarification WARNING or CAUTION A 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 CAUTION identifies special procedures or precautions that persons must obey to help prevent equipment damage ELECTRICAL SHOCK HAZARD WARNING The Vest Airway Clearance System Model 105 Page 1 User Manual 145330 REV 1 IMPORTANT SAFEGUARDS 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 DANGER To reduce the risk of electrocution follow these instructions Failure to do so could cause personal injury or equipment damage Always unplug this2. treatment press the ON button or the Press ON To Resume Remote Control again 10 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 11 When the OFF button is pressed twice the Incomplete 5 Min Remain inflatable vest Press ON for Main Menu deflates and the Incomplete 32 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Min Remain message shows on the screen You must press the ON button to continue to the Program and Ramp main screen 12 When the treatment session is complete a The Session Complete message Session Complete shows Press ON for Main Menu b The pulsations stop c The inflatable vest deflates d Unplug the system from its power source e Remove the Air Hoses from the Air Hose Ports on the inflatable vest f Remove the inflatable vest NOTE With a Chest Vest if a shoulder strap is unfastened the inflatable vest will have to be refitted for each use The Vest Airway Clearance System Model 105 Page 33 User Manual 145330 REV 1 USING THE PROGRAM MODE Runs a previously created New Program Mode WARNING Consult your physician prior to changing prescribed settings Failure
3. Page 26 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 a 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 b To adjust the Pressure setting press OFF KJ the middle Up nus or Down wo ee x Z arrow buttons until the prescribed treatment pressure shows on the screen The pressure may be set between 1 and 10 c 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 and 60 minutes NOTE It is not necessary to stop the treatment to adjust the settings 3 Press the ON button The inflatable vest will inflate Start Therapy Press ON NOTE If the unit is left in this mode for 10 minutes it will turn off 7 Hz 6 5 MIN The Vest Airway Clearance System Model 105 Page 27 User Manual 145330 REV 1 4 Press the ON button again to begin the treatment The set treatment Time shows as it counts down to zero 5 fitis necessary to pause the treatment during a session do as follows a Press the OFF button or Remote 7 Hz 6 5 MIN Control once Statt tee ees
4. USER MANUAL The Vest Airway Clearance System Model 105 From Hill Rom 145330 REV 1 2007 by Hill Rom Services Inc ALL RIGHTS RESERVED Manufactured by HILL ROM COMPANY INC 4349 CORPORATE ROAD CHARLESTON SC 29405 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 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 First Edition First Printing 2007 Printed in the USA Hill Rom is a registered trademark of Hill Rom Services Inc The UL logo is a registered trademark of Underwriters Laboratories Inc The Vest is a trademark of Hill Rom Services Inc Underwriters Laboratories Inc is a registered trademark of Underwriters Laboratories 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 The Vest Airway Clearance System Model 105 Pagei User Manual 145330 REV 1 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 prod
5. 2 Press the UP arrow button above OPTIONS 3 Press the Down arrow button below New Ramp to adjust the program settings 4 Look at the settings on the screen Ramp Time Percent is 25 Pct f ON Ramp Time Percent the portion of the Sor 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 OFF KJ 5 Press the ON button to advance to the next screen The Vest Airway Clearance System Model 105 Page 37 User Manual 145330 REV 1 6 Review the settings for Frequency and Pressure for the initial setting Ramp Start a 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 x setting press T 3 the middle Up er Ramp Start OFF lt 9 j or Down C E arrow buttons until the prescribed treatment Pressure shows on the screen Pressure may be set between 1 and 10 7 Press the ON button to advance to the next screen 8 Review the settings on the
6. Product Symbols 14 Instructions for Use 17 Protocol for Use and Special Instructions 17 Setting Up the Unit 18 Fitting the Chest 21 Fitting the Pull Vest 23 The Vest Airway Clearance System Model 105 Page iii User Manual 145330 REV 1 Quick start instructions 24 Using The Vest Airway Clearance System Model 105 dene eoe aM sot eS E La eM ET 26 Using the Normal Mode 26 Setting and Using the New Program Mode 30 Using the Program Mode 34 Setting and Using the New Ramp Mode 37 Using the Ramp Mode 42 Changing the Language 45 Disabling the Program Modes Program and Ramp modes 46 Setting Custom Default Settings 48 ary nie dey ri 52 Service Calls ci oe et Esa 52 Troubleshooting 53 Air Pulse Generator Does Not Power On 53 No Air Pulses into the Vest 53 Screen Shows Please Call for Service hioc Sule he oes 54 An air HOSE Comes out of the Air Pulse Generator or inflatable Vest during Operation 54 Screen Shows RESTARTING 55 The inflatable Vest No Longer Fits 55 Storage and
7. Remote Control bulb one time 10 To end treatment press the OFF button or squeeze the Remote Control bulb one time 11 Unplug the unit 12 Remove the inflatable vest 7 Hz 4 5 MIN Press ON To Resume The Vest Airway Clearance System Model 105 Page 25 User Manual 145330 REV 1 USING THE VEST AIRWAY CLEARANCE SYSTEM MODEL 105 Make sure the unit is set up correctly Once power is connected the unit will show a pres ones j blank screen for up to wr a gt 15 seconds Then it will show the model number and the total therapy hours for the unit This screen will show for 10 seconds or until you press the ON button NOTE To show the total therapy hours press the OFF button when the unit is on the main menu USING THE NORMAL MODE MODEL 105 xxxxx x HRS 1 Press the Up arrow button S above NORMAL NORMAL OPTIONS for the standard operation mode The screen will show the previously programmed Frequency Pressure and treatment Time settings either factory settings or settings programmed by your clinical trainer based on your doctors prescription 2 Confirm the settings on the screen If the settings match the prescribed treatment continue to step 3 Otherwise adjust the settings to match the prescription
8. The unit will stop the pulsations but the settings will continue to show on the screen NOTE When the unit is paused the inflatable vest will deflate b To resume treatment press the ON gt button or the Press To Resume Remote Control again 6 Ifit 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 7 When the OFF button is pressed twice the Incomplete 5 Min Remain inflatable vest Press ON tor Main Menu deflates and the Incomplete X Min Remain message shows on the screen You must press the ON button to continue to the main screen Page 28 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 8 When the treatment session is complete a The Session Complete message Session Complete Press ON for Main Menu shows b The pulsations stop c The inflatable vest deflates d Unplug the system from its power source e Remove the Air Hoses from the Air Hose Ports on the inflatable vest f Remove the inflatable vest NOTE With a Chest Vest if a shoulder strap is unfastened the inflatable vest will have to be refitted for each use The Vest Airway Clearance System Model 105 Page 29 User Manual 145330 REV 1 SETTIN
9. or equipment damage could occur 15 Use a correctly grounded electrical outlet only Failure to do so could cause equipment damage 16 Before cleaning unplug the unit from its power source Failure to do so could cause personal injury or equipment damage 17 Do not expose the unit to excessive moisture or immerse it in water Personal injury or equipment damage could occur 18 Do not run the Air Pulse Generator without the inflatable vest and Air Hoses attached Equipment damage could occur 19 Do not use harsh cleansers solvents or detergents Equipment damage could occur 20 Retain the original packaging material If shipping is required the original packing material provides the best protection for The Vest Airway Clearance System SAVE THESE INSTRUCTIONS Page 4 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 CONTRAINDICATIONS WARNING If conditions exist that prohibit using The Vest Airway Clearance System do not use the unit Death or serious injury could occur If the following conditions exist The Vest Airway Clearance System is not appropriate for use Head and or neck injury that has not yet been stabilized Active hemorrhage with hemodynamic instability RELATIVE CONTRAINDICATIONS According to the American Association for Respiratory Care AARC Guidelines for Postural Drainage Therapy the decision to use the unit for airway clearance therapy re
10. 105 Page 51 User Manual 145330 REV 1 MAINTENANCE A 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 7 If service is required on The Vest Airway Clearance System contact Hill Rom Customer Service For contact information refer to the back cover SERVICE CALLS When you contact Hill Rom about The Vest Airway Clearance System be prepared to give the serial number from the product identification label The product identification label is located on the back of the Air Pulse Generator When you give the serial number the Hill Rom representative can identify your unit and give you the information you need more quickly Page 52 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 TROUBLESHOOTING WARNING Only authorized personnel should service The Vest Airway Clearance System Servicing by unauthorized personnel could cause personal injury or equipment damage If service is required on The Vest Airway Clearance System contact Hill Rom Customer Service For contact information refer to the back cover AIR PULSE GENERATOR DOES NOT POWER ON 1 Make sure the Power Cord is securely plugged into the electrical inlet on the
11. AIR HOSES The Air Hoses connect the inflatable vest to the Air Pulse Generator REMOTE CONTROL The Remote Control can be used instead of the ON OFF control to pause or resume the Air Pulse Generator Page 12 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 INFLATABLE VEST The inflatable vest is available in two models the standard Chest Vest and the optional Full Vest When connected to the Air Pulse Generator by the Air Hoses the inflatable vest is controlled by the Air Pulse Generator to provide pulsations to the chest wall The Full Vest is available in a number of standard sizes and two neckline sizes The most appropriate size will be provided to you with the Air Pulse Generator and other accessories POWER CORD The Power Cord plugs into the Air Pulse Generator and a grounded outlet The Vest Airway Clearance System Model 105 Page 13 User Manual 145330 REV 1 PRODUCT SYMBOLS The following symbols are used on The Vest Airway Clearance System Symbol Definition e Type B equipment with an F type applied part according to 60601 1 Dangerous voltage within the device may constitute a risk of elec trical shock ON button starts the Air Pulse q O N Generator starts therapy inflates the inflatable vest starts the unit after being paused OFF button stops the Air Pulse Q Generator stops therap
12. Cord away from heated surfaces 7 Never drop or insert any inappropriate object into any opening on the unit Plug this product into a correctly grounded outlet only 9 Read and follow all instructions for setup use and maintenance of The Vest Airway Clearance System Failure to do so could cause patient injury or equipment damage 10 If conditions exist that prohibit using The Vest Airway Clearance System do not use the unit Death or serious injury could occur 11 Federal USA law restricts this device to sale by or on the order of a physician Sale by or on the order of unauthorized persons can cause patient injury 12 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 required in the United States contact Hill Rom Customer Service For contact information refer to the back cover Outside of the United States refer to the back cover for contact information For countries not listed on the back cover contact your distributor The Vest Airway Clearance System Model 105 Page 3 User Manual 145330 REV 1 13 The potential for electrical shock exists with electrical equipment Failure to follow protocols may cause death or serious personal injury 14 If the Air Pulse Generator is wet or damp do not plug it into a power source or use it Patient injury personal injury
13. Customer Service For contact information refer to the back cover For countries no listed on the back cover contact your distributor The Vest Airway Clearance System Model 105 Page 17 User Manual 145330 REV 1 SETTING UP THE UNIT NOTE If your physician has prescribed aerosol therapy to be used during the treatment set up the appropriate equipment W SHOCK HAZARD If the Air Pulse Generator is wet or damp do not plug it into a power source or use it Patient injury personal injury or equipment damage could occur 1 Make sure the Air Pulse Generator is not wet or damp 2 Plug the Power Cord into the back of the Air Pulse Generator A CAUTION Use a correctly grounded electrical outlet only Failure to do so could cause equipment damage 3 Plug the Power Cord into a correctly grounded outlet NOTE The Power Cord required for your country may be different than shown Page 18 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 NOTE Once the unit is plugged in the following will show on MODEL 105 xxxxx x HRS the screen or the ON ote button is pressed a The Model number b The total number of hours the device has been used NOTE To temporarily illuminate the backlight on the display press any one of the six Up or Down arrow buttons A CAUTION Do not run the Air Pulse Generator without
14. in of a typical commercial or hospital voltage variations for 0 5 for 0 5 environment If it is necessary for on power supply the user to have continued operation input lines cycle cycle of the Model 105 during power IEC 61000 4 11 40 UT 40 UT mains interruptions it is 60 dip in 60 dip in recommended that the Model 105 be for 5 for 5 powered from an uninterruptible cycles cycles power supply or a battery 70 UT 70 30 dip in 30 dip in for 25 UT for 25 cycles cycles lt 5 UT lt 5 UT 295 dip in gt 95 dip in for 5 for 5 seconds seconds Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz magnetic field 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC mains voltage prior to application of the test level The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Page 61 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 Test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GH
15. product immediately after using A WARNING To reduce the risk of burns electrocution fire or personal injury follow these instructions Failure to do so could cause personal injury or equipment damage 1 It may be necessary for patients who find it difficult to remove secretions from the upper airway such as those with DMD or other advanced neuromuscular or neurological disorders to include specialized therapy procedures along with use of The Vest Airway Clearance System These procedures may include manually or mechanically assisted coughing or other therapies Please consult your physician to determine if additional therapy is necessary 2 Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities 3 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 Page 2 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 4 Use this product only for its intended use as described in this manual Do not use attachments not recommended by the manufacturer 5 If this product has a damaged Power Cord or plug is not working properly or has been dropped or damaged do not operate it For examination and repair contact Hill Rom Customer Service For contact information refer to the back cover 6 Keep the unit and its Power
16. rear panel of the Air Pulse Generator If necessary unplug the Power Cord from the Air Pulse Generator and then reconnect 2 Make sure the Power Cord is securely plugged into an appropriate power source 3 If the problem still exists contact Hill Rom Customer Service For contact information refer to the back cover NO AIR PULSES INTO THE VEST 1 If using the Remote Control make sure it is securely connected to the Remote Control Port on the front panel of the Air Pulse Generator 2 Make sure the Air Hoses are connected to the inflatable vest and Air Pulse Generator 3 Ifthe problem still exists contact Hill Rom Customer Service For contact information refer to the back cover The Vest Airway Clearance System Model 105 Page 53 User Manual 145330 REV 1 SCREEN SHOWS PLEASE CALL FOR SERVICE MESSAGE The system has experienced an unexpected event Do as follows 1 Unplug the Power Cord from the Air Pulse Generator and then plug it in again If the problem is not corrected call Hill Rom Customer Service For contact information refer to the back cover AN AIR HOSE COMES OUT OF THE AIR PULSE GENERATOR OR INFLATABLE VEST DURING OPERATION 1 Fully disconnect the Air Hoses from the Air Pulse Generator and the inflatable vest Clean the inside and outside of these e Ends of the Air Hose Connection Ports on the inflatable vest e Air Hose Connector Ports outlets on the Air Pulse G
17. screen Frequency and Pressure for the final setting Ramp End are shown as treatment Time a To adjust the Frequency setting press the left Up or Down arrow buttons until the prescribed setting shows on the screen Frequency or Hertz Hz may be set between the Ramp Start setting and 20 cycles per second 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 Page 38 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 c 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 9 Press the ON button to advance to the next screen 05212Hz 01704 25 12Min This screen shows MCI CHOIR TNI ACTU the summary of the ramp program you have just created 10 Press the ON button The inflatable vest will inflate 11 Press the ON button again to begin the therapy EI a The screen will E show word Ramping during the ramp portion of the program The total treatment Time shows as it counts down to zero NOTE Therapy settings can not be changed during Ramping stage 12 If it is necessary to pause the treatment
18. the inflatable vest and Air Hoses attached Equipment damage could occur 4 Connect the Air Hoses to the Air Hose Connector Ports on the front of the Air Pulse Generator 5 Slightly twist the Air Hoses into the Air Hose Connector Ports to help secure the Air Hoses in position 6 Fit the inflatable vest Chest Vest Trefer to Fitting the Chest Vest on page 21 e Full Vest refer to Fitting the Full Vest on page 23 NOTE For patient comfort it is recommended that a single layer of cotton clothing be worn beneath the inflatable vest The Vest Airway Clearance System Model 105 Page 19 User Manual 145330 REV 1 7 Connect the Air Hoses to the ports on the inflatable vest Slightly twist the Air oF Hoses into the Air Hose J Connector Ports to help C a j Sfl BV secure the Air Hoses in position To use the optional Remote Control instead of the ON button plug the Remote Control into the port on the front of the Air Pulse Generator Page 20 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 FITTING THE CHEST VEST 1 Unfasten the back panel tabs from the main hook and loop fastener and separate the front and back panels of the Chest Vest 2 Turn the Chest Vest so the Air Hose Connector Ports are in front and slide the Chest Vest over the head 3 With the Chest Vest deflated temporarily attach both back panel tabs of the Chest Ve
19. to do so can cause personal injury Press the ON button 2 Press the UP arrow button above OPTIONS 3 Press the Up arrow button above PGM to run the previously created program or selected default program 4 Press the ON button The inflatable vest will inflate Press the ON button again to begin the A 12 Hz 4 7 MIN Press ON to Inflate treatment program The set treatment Time shows as it counts down to zero for each Programming Point Page 34 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 6 The therapy will automatically end after it has gone 12 Hz 4 7 MIN through each of the Programming Points 7 Ifitis necessary to pause the treatment during a session do as follows a Press the OFF button or Remote gt Control once Press ON To Resume The unit will stop the pulsations but the settings will continue to show on the screen NOTE When the unit is paused the inflatable vest will deflate b To resume treatment press the ON 2 gt button or the Press ON To Resume Remote Control again 8 Ifitis necessary to end the treatment session before it is com
20. 3 6030 dublin sales hill rom com Heas c o Hill Rom Japan Tel 81 0 3 5715 3420 Fax 81 0 3 5715 3425 Nordic Region Sverige Denmark Norge Hill Rom AB Tel 46 0 8 564 353 60 Fax 46 0 8 564 353 61 se marketing hill rom com South Fast Asia Hill Rom Singapore Tel 65 0 6391 1322 Fax 65 0 6391 1324
21. G AND USING THE NEW PROGRAM MODE New Program Mode allows the programming of up to eight 8 points with various settings within a single therapy session A WARNING Consult your physician prior to changing prescribed settings Failure to do so can cause personal injury 1 Press the ON button 2 P a 7 Hz 6 5 MIN Program Point 1 CREE NORMAL OPTIONS M OFF KJ 2 Pressthe UP arrow button above OPTIONS 3 Press the Down arrow button below New Pgm to create a new program The d screen will show the Frequency RAMP PGM k ON New Ramp New Pgm OFF v SN lt 7 wi A Pressure and treatment Time settings for the first Programming Point 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 Page 30 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 4 For Programming Point 1 if the settings match the fe prescribed Cc d treatment continue A to step 3 Otherwise adjust the settings to match the prescription by pressing the Up and Down arrow buttons associated with Frequency Pressure and treatment Time 5 Once you have set Pro
22. al packing material provides the best protection for The Vest Airway Clearance System Retain the original packaging material Failure to do so could cause equipment damage If shipping is required ship the unit in its original packing material Page 56 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 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 Does The Vest Airway Clearance System effectively treat all areas of my lungs Yes The system oscillates the chest wall to create airflow to all lung areas to effectively treat all lobes of the lung at once How long should my Airway Clearance Therapy treatment session last Common prescriptions specify a treatment session time to be between 10 and 30 minutes Prescribed treatment session times may be different How often should my treatment sessions be given The frequency of treatment sessions depends on your underlying disease age and state of health Your physician will prescribe a schedule for your individual needs s chest physiotherapy still necessary Ina number of studies The Vest Airway Clearance System has been shown to supply more effective Airway Clearance Therapy than conventional chest physiot
23. bacterial soap or solution Dilute the disinfectant as specified on the manufacturer s label ACRONYMS Acronym Meaning AARC American Association for Respiratory Care AWG American Wire Gauge CSA Canadian Standards Association HFCWO High Frequency Chest Wall Oscillation ICP Intercranial pressure PVC Polyvinyl chloride UL Underwriters Laboratories Inc a Underwriters Laboratories Inc is a registered trademark of Underwriters Laboratories Inc Page 8 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 INTENDED USE WARNING Read and follow all instructions for setup use and maintenance of The Vest Airway Clearance System Failure to do so could cause patient injury or equipment damage This manual includes instructions for setup use and maintenance of The Vest Airway Clearance System Model 105 Before setting up the The Vest M Airway Clearance System carefully read all of this manual Following these instructions helps make sure the unit is used safely and helps maximize the therapeutic benefit of your treatment Most importantly obey all warnings cautions and notes in this manual NOTE This manual is not intended as a substitute for information you receive from your physician or other healthcare providers Use The Vest Airway Clearance System as intended for use as prescribed by your physician The Vest Airway Clearan
24. ce System Model 105 Page 9 User Manual 145330 REV 1 INTRODUCTION The Vest Airway Clearance System was developed to help provide effective airway clearance The unit has an inflatable vest attached by Air Hoses to an Air Pulse Generator The Air Pulse Generator rapidly inflates and deflates the inflatable vest to gently compress and release the chest wall creating airflow within the lungs This process which mimics coughing moves mucus toward the large airways where it can be cleared by coughing or suctioning This type of airway clearance therapy is referred to as High Frequency Chest Wall Oscillation HFCWO Page 10 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 FEATURES A Air Pulse Generator D Remote Control B Air Hose Connection E Control Panel Ports C Air Hoses AIR PULSE GENERATOR When correctly connected the Air Pulse Generator controls the inflatable vest and supplies pulsations to the chest wall CONTROL PANEL Pressing the ON or OFF controls or the 6 Up and Down arrow buttons activates or deactivates the Air Pulse Generator The Vest Airway Clearance System Model 105 Page 11 User Manual 145330 REV 1 AIR HOSE CONNECTOR PORTS The Air Hoses connect to the Air Pulse Generator at the two Air Hose Connector Ports on the face of the Air Pulse Generator
25. during a session do as follows a Press the OFF button or Remote Control once The unit will stop the pulsations but the settings will continue to show on the screen The Vest Airway Clearance System Model 105 Page 39 User Manual 145330 REV 1 NOTE When the unit is paused the inflatable vest will deflate b To resume treatment press the ON AE 1 B MIN button or the Press ON To Resume 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 When the OFF button is pressed twice the Incomplete 5 Min Remain inflatable vest Press ON for Main Menu deflates and the Incomplete X Min Remain message shows on the screen You must press ON to continue to the main screen 15 When the treatment session is complete a The Session Complete message Session Complete shows Press ON for Main Menu b Thepulsations stop The inflatable vest deflates d Unplug the system from its power source e Remove the Air Hoses from the Air Hose Ports on the inflatable vest Page 40 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 f Remove the inflatable vest NOTE With a Chest Vest if a shoulder strap is unfastened
26. en NOTE When the unit is paused the inflatable vest will deflate 7 Hz 4 5 MIN Press ON To Resume b To resume treatment press the ON ETE n S MIN button or the Press To Resume Remote Control again 8 Ifit 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 The Vest Airway Clearance System Model 105 Page 43 User Manual 145330 REV 1 9 When the OFF button is pressed twice the inflatable vest noo en deflates and the Incomplete X Min Remain message shows on the screen You must press the ON button to continue to the main screen Incomplete 5 Min Remain 10 When the treatment session is complete a The Session Complete message Session Complete shows Press ON for Main Menu b Thepulsations stop The inflatable vest deflates d Unplug the system from its power source e Remove the Air Hoses from the Air Hose Ports on the inflatable vest f Remove the inflatable vest NOTE With a Chest Vest if a shoulder strap is unfastened the inflatable vest will have to be refitted for each use Page 44 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 CHANGING THE LANGUAGE 1 Pr
27. enerator Connect the Air Hoses to the Air Pulse Generator and the inflatable vest see Setting Up the Unit on page 18 If the problem is not corrected call Hill Rom Customer Service For contact information refer to the back cover Page 54 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 SCREEN SHOWS RESTARTING 1 The system has experienced an unexpected event and is restarting 2 If the problem is not corrected call Hill Rom Customer Service For contact information refer to the back cover THE INFLATABLE VEST NO LONGER FITS 1 Adjust the inflatable vest to accommodate normal growth e To fit a Chest Vest refer to Fitting the Chest Vest on page 21 To fit a Full Vest refer to Fitting the Full Vest on page 23 2 If the problem still exists contact Hill Rom Customer Service For contact information refer to the back cover The Vest Airway Clearance System Model 105 Page 55 User Manual 145330 REV 1 STORAGE AND HANDLING To store or transport The Vest Airway Clearance System do as follows 1 Put the Air Pulse Generator in the roller bag 2 Put the Air Hoses in either of the end compartments 3 Put the inflatable vest in the other end compartment along with the Remote Control and Power Cord 4 Close the roller bag to secure the unit inside SHIPPING THE UNIT CAUTION If shipping is required the origin
28. ess 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 until the screen changes Press the Down arrow button below Spanish it will turn Spanish to ESPANOL To accept the change press the Down arrow button below ACEPTAR ACCEPT in English 2 4 NORMAL Kl ON 7 Hz 4 Press ON To Res e a Defaults Pr ograms ACCEPT OFF ENGLISH Spanish S Predeter Ky ingl s ESPA OL ACEPTAR or R 2 j I T 29 you have accepted change the system will automatically re boot and go back to the main screen in Spanish The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Page 45 7 Once the main screen is visible unplug the unit and plug it back in The unit will automatically reconfigure in Spanish 8 To switch back to English repeat the steps and choose ingles instead of Spanish DISABLING THE PROGRAM MODES PROGRAM AND RAMP MODES 1 Press the ON button 2 Press the left Up arrow button above NORMAL The Normal mode scree
29. gramming Point 1 proceed to Programming Point 2 by pressing the ON button to move to a previous 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 Point 2 set the Time to 0 MIN for the following segment NOTE Once you change the Programming Point Time to 0 MIN and press the ON button it will take you to the start of the program to begin therapy 6 Press the ON button The inflatable vest will inflate Press ON to Inflate 7 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 7 Hz 6 5 MIN The Vest Airway Clearance System Model 105 Page 31 User Manual 145330 REV 1 8 Therapy will automatically end after it has gone through each a Programming S Point 12 Hz 4 7 MIN 9 fitis necessary to pause the treatment during a session do as follows a Pressthe OFF button or lt os Pd Remote 7 Hz 4 5 MIN Control once Press ON To Resume The unit will stop the pulsations but the settings will continue to show on the screen NOTE When the unit is paused the inflatable vest will deflate b Toresume
30. he unit is Type B equipment with an F type applied part 1 Underwriters Laboratories Inc is a registered trademark of Underwriters Laboratories Inc Page 60 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 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 60601 Compliance Electromagnetic Environment Test Test Level Level Guidance Electrostatic 6kV 6kV Floors should be wood concrete or discharge ESD contact contact ceramic tile If floors are covered IEC 61000 4 2 8 air 8 air with synthetic material the relative humidity should be at least 30 Electrical fast 2 for 2 for Mains power quality should that transient burst power supply power supply of a typical commercial or hospital 61000 4 4 lines lines environment 1 for 1 for input output input output lines lines Surge t1kV 1kV Mains power quality should be that TEC 61000 4 5 differential differential of a typical commercial or hospital mode mode environment 2 2 mode mode Voltage dips short lt 5 UT lt 5 Mains power quality should be that interruptions and 59596 dip in gt 95 dip
31. herapy Typically it is not necessary to do chest physiotherapy along with therapy treatment sessions with The Vest Airway Clearance System The Vest Airway Clearance System Model 105 Page 57 User Manual 145330 REV 1 Is postural drainage still necessary The Vest Airway Clearance System moves mucus by generating airflow within the lungs It works in any position so generally it should not be necessary to do postural drainage Refer to the physician s order What will happen if I miss a treatment session One missed treatment session of the system may or may not affect your health However the key to help maintain your health is consistent effective therapy Follow the doctor s care plan as closely as possible Consult your doctor if a treatment session is missed Is there a best time to do a therapy with The Vest Airway Clearance System Establish a schedule that works for you and your family and lets you do the therapy consistently Usually it is best to do therapy before meals Do all patients receive the same benefits from The Vest Airway Clearance System Almost all patients will experience an increase in the amount of mucus that is moved The overall benefit depends on many factors which include the underlying disease patient s age and present state of health Will The Vest Airway Clearance System make me feel better Patients often report that they are able
32. ld it under itself to make sure the Full Vest fits correctly a Loosen the front closures b Fold the top flap under itself c Tighten the front closures The Vest Airway Clearance System Model 105 Page 23 User Manual 145330 REV 1 QUICK START INSTRUCTIONS 1 Make sure the inflatable vest is put on correctly 2 Make sure the unit is set up correctly Press the ON button The display will come on 4 Press the UP arrow button pi above NORMAL AAT KM ON 5 Press the ON button to inflate the inflatable vest ym a The current Press ON to Inflate Frequency N Pressure and Time settings will be shown 6 Use the Up and Down arrows to adjust the setting to match your prescription 6 5 MIN OFF KJ ress ON 9 j Fm 7 7 Press the ON button to begin treatment a Start Therapy Press ON Page 24 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 8 To pause treatment press the OFF button or squeeze the Press To Pause Remote Control bulb one time 7 Hz 6 5 MIN 9 To resume treatment press the ON button or gt squeeze the Press To Resume
33. n shows 3 Press the two outside Down arrow buttons for a minimum of 3 seconds or until the screen changes Defaults Programs 4 Press the right Up ENGLISH Spanish ACCEPT arrow button above Programs 5 Press the right Up arrow button above PGM ENABLE pgm disable disable It will ACCEPT turn to PGM DISABLE Page 46 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 6 To accept the change press the right Down arrow below ACCEPT 2 S a a lt a pgm enable PGM E 7 accept all changes and exit out of the menu press the right Down arrow button below ACCEPT 8 Once you have accepted the change the system will automatically re boot and go to the main screen of NORMAL You will no longer be able to see the Program or Ramp mode programs 9 To switch back to Program Mode repeat the steps starting at step 2 NOTE Press the Up arrow button above pgm enable at step 4 to enable the Program Mode It will change pgm enable to PGM ENABLE The Vest Airway Clearance System Model 105 Page 47 User Manual 145330 REV 1 SETTING CUSTOM DEFAULT SETTINGS 1 Press the ON button 2 Press the Up arrow bu
34. plete press the OFF button twice NOTE Pressing the OFF button does not turn off the screen 9 When the OFF button is pressed twice the Incomplete 5 Min Remain inflatable vest Press ON tor Main Meng deflates and the Incomplete X The Vest Airway Clearance System Model 105 Page 35 User Manual 145330 REV 1 Min Remain message shows on the screen You must press the ON button to continue to the Program and Ramp main screen 10 When the treatment session is complete a The Session Complete message shows Press ON for Main Menu Session Complete b The pulsations stop The inflatable vest deflates d Unplug the system from its power source e Remove the Air Hoses from the Air Hose Ports on the inflatable vest f Remove the inflatable vest NOTE With a Chest Vest if a shoulder strap is unfastened the inflatable vest will have to be refitted for each use Page 36 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 SETTING AND USING THE NEW RAMP MODE Creates a new Ramp Program to ease the patient from lower setting to a higher setting during a limited period of the therapy session WARNING Consult your physician if not using the prescription as provided Failure to do so can cause personal injury 1 Press the ON button
35. quires careful consideration and assessment of the individual patient s case if the following conditions exist Intracranial pressure ICP greater than 20 mm Hg Recent spinal surgery or acute spinal injury Bronchopleural fistula Pulmonary edema associated with congestive heart failure Large pleural effusions or empyema Pulmonary embolism Rib fractures with or without flail chest Surgical wound or healing tissue or recent skin grafts or flaps on the thorax Uncontrolled hypertension The Vest Airway Clearance System Model 105 Page 5 User Manual 145330 REV 1 Distended abdomen Recent esophageal surgery Active or recent gross hemoptysis Uncontrolled airway at risk for aspiration such as tube feeding or a recent meal e Subcutaneous emphysema Recent epidural spinal infusion or spinal anesthesia Burns open wounds and skin infections on the thorax Recent placement of transvenous or subcutaneous pacemaker e Suspected pulmonary tuberculosis Lung contusion Bronchospasm Osteoporosis or osteomyelitis of the ribs Coagulopathy Complaint of chest wall pain Page 6 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 CLEANING A WARNING Follow the product manufacturer s instructions Failure to do so could cause personal injury or equipment damage SHOCK HAZARD The potential for electrical shock exists with electrical equipment Failure to follow protocol
36. s may cause death or serious personal injury W SHOCK HAZARD Unplug the unit from its power source Failure to do so could cause personal injury or equipment damage W SHOCK HAZARD Do not expose the unit to excessive moisture or put it in water or any solution Personal injury or equipment damage could occur A CAUTION Do not use harsh cleansers solvents or detergents Equipment damage could occur GENERAL CLEANING We recommend that you clean the Air Pulse Generator and inflatable vest with detergent and warm water Do not use excessive liquid or harsh cleansers and do not put The Vest Airway Clearance System in water or any solution STEAM CLEANING Do not use any steam cleaning device on the unit Excessive moisture can damage mechanisms in this unit The Vest Airway Clearance System Model 105 Page 7 User Manual 145330 REV 1 CLEANING HARD TO CLEAN SPOTS To remove difficult spots or stains we recommend that you use standard household cleansers and a soft bristle brush To loosen heavy dried on soil you may first need to saturate the spot Do not put The Vest Airway Clearance System in water or any solution DISINFECTING When there is visible soilage and also between patient use in multi patient care environments we recommend that you disinfect the unit Use an Environmental Protection Agency EPA registered US only tuberculocidal disinfectant or standard household mild anti
37. st to the front panel 4 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 eo 5 Detach both back panel tabs from m 0 the front of the Chest Vest D 6 For the best fit inhale deeply and N then secure both back panel tabs to the front panel j The Vest Airway Clearance System Model 105 Page 21 User Manual 145330 REV 1 7 Make sure the Chest Vest fits close to the body without being uncomfortably snug tighten the fit at the bottom edge angle the back panel tabs upward e loosen the fit at the bottom edge angle the back panel tabs downward Page 22 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 FITTING THE FULL VEST 1 Put the Full Vest on so the closures are in front 2 Connect the closures so the Full Vest fits loosely over the chest 3 Using the shoulder straps adjust the length of the Full Vest so its bottom edge is level with the top of the hip bone 4 Using the front closures adjust the Full Vest to fit close to the body without being uncomfortably snug tighten the front closures hold the buckle and pull the end of the strap to the patient s right To loosen the front closures gently lift the back of the buckle and lengthen the strap 5 If any excess material is under the front closures fo
38. structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters the electromagnetic site used should be considered If the measured field strength in the location in which the Model 105 is used is more than the applicable RF compliance level above the Model 105 should be monitored to make sure it operates correctly If it operates incorrectly additional measures may be necessary such as a change in the Model 105 s position or location b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m The Vest Airway Clearance System Model 105 Page 63 User Manual 145330 REV 1 Page 64 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Hill Rom Global Headquarters US Hill Rom Company Inc 1069 State Route 46 E Batesville IN 47006 9167 Tel 800 445 3720 www hill rom com US Rental Therapy Hill Rom Company Inc Tel 800 638 2546 Australia Hill Rom Australia Pty Ltd Tel 61 0 2 8814 3000 Fax 61 0 2 8814 3030 E Hill Rom Shanghai Tel 86 0 21 5396 6933 Fax 86 0 21 5383 3136 France Hill Rom SAS Tel 433 0 2 97 50 92 12 Service 33 0 820 01 23 45 Fa
39. the inflatable vest will have to be refitted for each use The Vest Airway Clearance System Model 105 Page 41 User Manual 145330 REV 1 USING THE RAMP MODE Coa Runs a previously created Ramp Program WARNING Consult your physician if not using the prescription as provided Failure to do so can cause personal injury 1 Press the ON button 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 p05 gt 12Hz 01204 25 12Min ON button to Press ON to Inflate advance to the gt next screen Press the ON button The inflatable vest will inflate Page 42 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 6 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 can not be changed during Ramping stage 7 Ifitis necessary to pause the treatment during a session do as follows a Press the OFF button or Remote Control once The unit will stop the pulsations but the settings will continue to show on the scre
40. to breathe better and have more energy after therapy Page 58 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 SPECIFICATIONS material Chest Vest Feature Dimension Air Pulse Generator 17 Ib 8 kg weight Air Pulse Generator 9 5 24 1 cm height Air Pulse Generator 13 33 cm width Air Pulse Generator 9 5 24 1 cm depth Inflatable vest Polyvinyl chloride PVC coated polyester with polyurethane coated nylon Inflatable vest Polyurethane coated nylon material Full Vest Electrical 100 V AC to 230 V AC 50 Hz requirements to 60 Hz 3 4 A 100 VAC 2 0 A 230 VAC Fuse requirement 2 each 4 A 5 x 20 mm Littel fuse part number F4AL250V Environmental Conditi ons for Transport and Storage Condition Range Temperature 40 F to 158 F 40 C to 70 C Relative humidity 95 non condensing Atmospheric pressure 500 hPa to 1060 hPa The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Page 59 Environmental Conditions for Use Condition Range Temperature 50 F to 93 F 10 C to 34 C ambient temperature Relative humidity range 30 to 75 non condensing Atmospheric pressure 700 hPa to 1060 hPa REGULATIONS CODES AND STANDARDS The Vest Airway Clearance System is listed with Underwriters Laboratories Inc UL to US and Canadian product safety standards T
41. to the next default e 2 gt setting Program Point 4 10 MIN OFF KJ ings lt j The Vest Airway Clearance System Model 105 Page 49 User Manual 145330 REV 1 12 Adjust the Ramp Time Percent for the Default Ramp aN a 25 Pct ON OFF KJ mode using the Ramp Time Percent 9 o 2 j right Up and gt z 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 arrow buttons and press the ON button 14 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 15 To accept all of the changes press the right Down arrow below ACCEPT Page 50 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 16 Once you have accepted the change it will automatically re boot the system and go back to the main screen 17 To switch back to previous patient default mode repeat the steps and select prev pt instead of default The Vest Airway Clearance System Model
42. tton above NORMAL The Normal mode screen shows 3 Press the two outside Down arrows for a minimum of 3 seconds or until the screen changes 4 Press the left Up arrow button f above Defaults Defaults Programs ENGLISH Spanish ACCEPT 5 Press the right Up arrow button above default Defaults will change to DEFAULTS 6 To accept the change press the right Down arrow button below ACCEPT prev pt DEFAULT OFF IV 2 x Page 48 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 7 To adjust the Maximum Run Time use the Up and Down arrow buttons above and below MIN and then press the ON button 8 To set default Frequency Pressure and Time settings for ings TT Normal Mode adjust each by using the respective Up and Down arrow buttons and press the ON button 9 To adjust the default settings for Program Mode set each Program Point sequentially Press the ON button to advance to the next Programming Point 10 Adjust Frequency Pressure and Time for each Program Point 1 thru 8 or change the time to zero after Program Point 3 to make the previous point the last point 11 Press the ON button to advance
43. ucts To order additional copies of this manual 145330 refer to the back cover for contact information For countries not listed on the back cover contact your distributor NOTE The back cover is a comprehensive list of Technical Support contact information for Hill Rom The product discussed in this manual may not be available in all of the countries listed Revision Pages Affected Date Original Issue February 2007 Page ii The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Table of Contents Document Symbols 1 Important Safeguards 2 Contraindications 5 Relative Contraindications 5 1 ed ee eh ee pees ee peer waa 7 General Cleaning 7 steam Cleant g xri ee REA VE 7 Cleaning Hard to Clean Spots 8 Disinfecting i 4 e the Rein be eae 8 ACDOBIBS phe ee petiit aud t ea eee SY 8 Intended Use scope e qus honor E Pee R 9 Introductio sen oe CE 7 ass ue Trag 10 Beatutes cesa ev E ahaa 11 Air Pulse Generator 11 Control Panel ser Vs uv vests ws 11 Air Hose Connector Ports 12 Air HOSES sso eh ERE S 12 Remote Control 12 Inflatable Vesti ete eed 13 POWER Cord cdita c mod LI mS 13
44. x 33 0 2 97 50 92 00 Italia Hill Rom S p A Tel 39 0 02 950541 Fax 39 0 02 95328578 Nederland Hill Rom Medical Services BV Tel 31 0 347 32 35 32 Fax 31 0 347 32 35 00 Osterreich Hill Rom Austria GmbH Tel 43 0 2243 28550 Fax 43 0 2243 28550 19 austria hill rom com Suisse Schweiz Hill Rom SA Tel 41 0 21 706 21 30 Fax 41 0 21 706 21 33 hrch info G hill rom St Paul MN Hill Rom Company Inc Tel 651 490 1648 or 800 426 4224 www thevest com Belgique Belgi Hill Rom Medical Services BV Tel 31 0 347 32 35 32 Fax 31 0 347 32 35 00 Deutschland Hill Rom GmbH Tel 49 0 211 16450 0 Fax 49 0 211 16450 182 ie Hong Kong Hill Rom Asia Ltd Tel 852 0 2297 2395 Fax 852 0 2297 0090 AAS Hill Rom Japan Tel 81 0 3 5715 3420 Fax 81 0 3 5715 3425 New Zealand c o Hill Rom Australia Pty Ltd Tel 61 0 2 8814 3000 Fax 61 0 2 8814 3030 Portugal Hill Rom Iberia S L Tel 34 0 93 685 6009 Fax 34 0 93 666 5570 United Kingdom Hill Rom Ltd Tel 44 0 1530 411000 Fax 44 0 1530 411555 International Hill Rom Company Inc International Department Tel 1 0 812 934 8173 Fax 1 0 812 934 7191 www hill rom com international hill rom com Canada Hill Rom Canada Tel 800 267 2337 Espa a Hill Rom Iberia S L Tel 34 0 93 685 6009 Fax 34 0 93 666 5570 Ireland Hill Rom Ltd Tel 353 0 1 413 6005 Fax 353 0 1 41
45. y pauses therapy Frequency setting Pressure setting Page 14 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 Definition 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 Class equipment double insu lated according to EN60601 1 Not protected against water ingress The Vest Airway Clearance System User Manual 145330 REV 1 Model 105 Page 15 15BF Definition Medical Equipment with respect to electric shock fire mechanical and other specified hazards only in accordance with UL EN IEC 60601 1 and CAN CSA C22 2 No 601 1 NO OO Conforms to the European Medical Device Directive 93 42 EEC Manufacturer or distributor com plies with the Waste Electric and Electronic Equipment Directive 2002 96 EC Page 16 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 INSTRUCTIONS FOR USE PROTOCOL FOR USE AND SPECIAL INSTRUCTIONS Your physician has prescribed The Vest Airway Clearance System to be used times per day Additional Instructions NOTES If you have any questions or concerns contact Hill Rom
46. z Compliance Level 3 V m Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Model 105 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 80 MHz to 800 MHz 800 MHz to d JP 3 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Page 62 The Vest Airway Clearance System Model 105 User Manual 145330 REV 1 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 Test Test Level Level Electromagnetic Environment Guidance Field strengths from fixed RF transmitters as found by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with this symbol NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from
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