USER MANUAL - The Vest® Airway Clearance System
Contents
1. Item Control Description A ON Press to fill the inflatable vest and start or pause the Air Pulse Generator B and C Frequency Up Press to adjust the Frequency setting until the and Down prescribed treatment session Frequency shows on the display D and E Pressure Up Press to adjust the Pressure setting until the and Down prescribed treatment session Pressure shows on the display F and G Treatment Press to adjust the treatment Time until the Time Up and prescribed treatment session Time shows on Down the display H OFF Press to stop the Air Pulse Generator 12 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 The display shows the current Frequency Pressure and treatment Time settings and system messages NOTE The display shows its messages in English For a translation of the messages in your language refer to Display Messages on page 47 Remote Control and Air Hoses The Remote Control can be used instead of the ON control to start or pause the Air Pulse Generator rrr Su Ml The Air Hoses ug A ZA MUM connect the inflatable E Ge S cam wm vest to the Air Pulse LINT D Generator lt Q TT Power Cord The Power Cord plugs into the Air Pulse Generator and a grounded outlet NOTE The Power Cord necessary for your country may be different than the one shown The Ves t Airway Clearance System M2. What will happen if a patient s treatment session 1s 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 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 45 therapy Try to follow the patient s care plan as closely as possible Is there a best time to do The Vest Airway Clearance System Model 104 therapy Establish a schedule that is satisfactory for the patient 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 Model 104 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 his or her present state of health Does The Vest Airway Clearance System Model 104 make patients feel better Patients often report that they are able to breathe better and have more energy after he or she receives therapy 46 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Display Messages storing no X Display Message French Italian German Total Use Total utilisation Uso totale Betriebsstunden XXXX X Hours XXXX X hrs XXXX X ore XXXX X Std In
3. fasteners 2 Turn the disposable vest so the front flaps will meet in front of the patient Then put the patient s arms through the arm openings in the disposable vest 3 With the disposable vest deflated use the Velcro fasteners to attach the front flaps of the disposable vest to each other 4 Make sure there is approximately 3 to 4 8 cm to 10 cm between the bottom edge of the front of the disposable vest and the patient 5 Adjust the Velcro fasteners at the shoulder straps so the bottom edge of the disposable vest is level with the top of the patient s hip bone 1 Velcro is a registered trademark of Velcro Industries BV a Dutch Corporation The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 33 Use The Vest Airway Clearance System Model 104 1 Make sure the unit is set up correctly see Set Up the Unit on page 25 2 Press the ON control The inflatable vest fills and the display shows the previously used Frequency and Pressure settings and the remaining treatment session Time 3 Look at the settings on the ape SSS display If the settings match your D prescribed treatment session iN wii continue to step 4 Otherwise ae ae a adjust the settings to match your prescription as follows UN 6 20 MIN Joe 4 a To adjust the Frequency setting press the left hand Up and Down arrow controls until your p
4. Do not immerse The Vest Airway Clearance System Model 104 in water or allow liquids to enter the Air Pulse Generator After you clean the system wipe it dry Steam Cleaning Do not use any steam cleaning device on the unit Excessive moisture can damage mechanisms in this unit Cleaning Hard to Clean Spots Air Pulse Generator 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 any component of The Vest Airway Clearance System Model 104 in water Disinfecting 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 Intended Use A WARNING Read and obey all of the instructions for setup use and maintenance for The Vest Airway Clearance System Model 104 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 104 Before you use the system carefully read all of this manual and make sure you obey the instructions for your safety and to get the best therapeutic benefit Most importantly obey all warnings cautions and notes in this manual The Ves t Air
5. d P M LJ current pati ent Ir NOTE The Power Cord necessary for your country may be different than the one shown The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 25 NOTE To temporarily turn on the backlight on the display press any one of the six Up or Down arrow controls A CAUTION Do not operate the Air Pulse Generator without the inflatable vest and Air Hoses attached Equipment damage could occur 4 Connect the Air Hoses to the air outlets on the front of the Air Pulse Generator AA CAUTION If it is difficult to connect the Air Hose to the Air Pulse Generator or inflatable vest do not use lubricant Equipment damage could occur 5 Slightly twist each Air Hose into its air outlet to help keep it in position If it is difficult to connect the Air Hose to the Air Pulse Generator do not use lubricant 6 Put on an inflatable vest see Put on the Inflatable Vest on page 29 26 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Connect the Air Hoses to the Air Hose ports on the inflatable vest If it is difficult to connect the Air Hose to the inflatable vest do not use lubricant Reusable or disposable Full Vest slide the end of each Air Hose over the inflatable vest Air Hose ports To help keep the Air Hoses in position slightly twist the Air Hoses as you push them over the inflatable vest Air Hose ports Reusable Ches
6. 104 User Manual USR150 REV 3 23 Instructions for Use Protocol for Use and Special Instructions for the Home Care Patient Your physician has prescribed The Vest Airway Clearance System Model 104 to be used times per day Additional Instructions NOTES If you have any questions or concerns call Hill Rom Technical Support For contact information refer to the back cover 24 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Set Up the Unit NOTE If your physician has prescribed aerosol therapy to be used during your treatment session set up the applicable equipment 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 SHOCK HAZARD Use a known good electrical outlet only Do not use the Air Pulse Generator with an extension cord or multiple use electrical outlet adapter Death serious injury or equipment damage could occur 3 Plug the Power Cord into a known good electrical outlet Once the unit is plugged in the display shows this data a Software revision p LO AN b Total number of hours the E E device has been used by the ee ee
7. not use this system near flammable anaesthetics A WARNING To reduce the risk of burns electrocution fire or personal injury obey these instructions Failure to do so could cause personal injury or equipment damage Patients that may have difficulty clearing secretions from the upper airway such as those with DMD or other advanced neuromuscular or neurological disorders may require specialized therapy regiments involving manually or mechanically assisted coughing or other techniques in conjunction with The Vest Airway Clearance System Model 104 therapy Please consult your physician to determine if additional therapy is appropriate 2 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Use close supervision throughout the treatment when this system is used by or near children or patients with physical limitations or impaired cognitive abilities Use this system only for its intended use Use only those attachments that are specified by the manufacturer Ifthis system has a damaged Power Cord or plug does not operate correctly or has been dropped or damaged do not operate it For test and repair call Hill Rom Technical Support For contact information refer to the back cover Keep the unit and its Power Cord away from heated surfaces Never drop or insert inappropriate objects into any opening on the unit Plug this system into a known good outlet only Read and obey all ins
8. of The Vest Airway Clearance System Model 104 do not use the system Death or serious injury could occur Do not use The Vest Airway Clearance System Model 104 if the patient has one or more of these conditions Head and or neck injury that has not been stabilised Active hemorrhage with hemodynamic instability Relative Contraindications If the patient has one or more of the conditions below before you use The Vest Airway Clearance System carefully consider and assess the patient s case in accordance with the American Association for Respiratory Care AARC Guidelines for Postural Drainage Intracranial pressure ICP 220 mm Hg or patients in whom increased intracranial pressure is to be avoided 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 Distended abdomen Recent esophageal surgery Active or recent gross hemoptysis Uncontrolled airway at risk for aspiration such as Air Hose feeding or a recent meal Subcutaneous emphysema The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 5 Recent epidural spinal infusion or spinal anesthesia Burns open wounds and skin infections on the thorax Transvenous or subcuta
9. the Air Hose e Air Hose ports on the inflatable vest e Air outlets on the Air Pulse Generator 3 Connectthe Air Hose to the Air Pulse Generator and inflatable vest see Set Up the Unit on page 25 4 Ifthe problem is not corrected call Hill Rom Technical Support For contact information refer to the back cover The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 43 Storage and Handling Storage Bag Home Care Environment To store or transport The Vest Airway Clearance System Model 104 put the unit in its storage bag 1 4 5 Put the Air Pulse Generator in the center of the storage bag Put each Air Hose ma separate compartment on each side of the Air Pulse Generator Put the inflatable vest in one side pocket Put the Remote Control and Power Cord in the other side pocket Close the top of the storage bag Shipping the Unit A CAUTION If shipping is necessary the original packing material protects the system during shipment Keep the original packing material for use if you need to ship the system Failure to adequately package the system for shipment could cause equipment damage If shipping is necessary ship the unit in its original packing material 44 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Frequently Asked Questions Is The Vest Airway Clearance System Model 104 as effective as chest physi
10. 0 ES Not protected against water ingress S SI d 15BF N a 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 a The UL logo is a registered trademark of Underwriters Laboratories Inc 16 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Symbol CE 0123 Definition Conforms to the European Medical Device Directive 93 42 EEC Identifies a replaceable fuse link in an elec tronic circuit Manufacturer or distributor complies with the Waste Electric and Electronic Equipment Directive 2002 96 EC The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 17 Specifications Feature Dimension Air Pulse Generator weight 17 lb 8 kg Air Pulse Generator height 9 5 24 1 cm Air Pulse Generator width 13 33 cm Air Pulse Generator depth 9 5 24 1 cm Inflatable vest material Reusable Chest Vest Polyvinyl chloride PVC coated polyester with polyurethane coated nylon Inflatable vest material Reusable Full Vest Polyurethane coated nylon Inflatable vest material Disposable Wrap and Full SPU Vest PVC coated thermally bonded nylon Electrical requirements 100 V AC to 230 V AC 50 Hz to 60 Hz 2 9 A at 100 V 2 0 A at 230 V Fuse requirement 2 eac
11. AS Tel 33 0 2 97 50 92 12 Service 33 0 820 01 23 45 Fax 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 ful Hong Kong Hill Rom Asia Ltd Tel 852 0 2297 2395 Fax 852 0 2297 0090 AA 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 02 8814 3000 Fax 61 0 2 8814 3030 Portugal Hill Rom Iberia S L Tel 434 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 Irel
12. To start the treatment session again press the ON control or the Remote Control again NOTE If the treatment session is stopped for 10 minutes the unit automatically turns off 6 fitis necessary to end the treatment session before it is complete press the OFF control NOTE The OFF control does not turn off the display 7 Whenthe OFF control is pressed the inflatable vest deflates and d REENEN fe QN k oa 1INGOMDLETE ANX MIN REMAIN asp the INCOMPLETE XX MIN REMAIN message shows briefly on the display hae NES NE RZ Z Gg The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 35 8 When the treatment session is complete these actions occur e The SESSION ore COMPLETE message f EA shows briefly and then the t vu SESSION COMPLETE lem TOTAL USE message Uara a ae Ji shows The pulsations stop sees EH s The inflatable vest deflates SS ARI GFF e The backlight on the display ee enu oeque J Wi oO c goes off NOTE The TOTAL USE message shows on the display until the system is unplugged from its power source 9 To temporarily turn the backlight on press any one of the six Up or Down arrow controls 10 When the treatment session is complete do as follows a Immediately unplug the system from its power source b Remove the Air Hoses
13. USER MANUAL The Vest Airway Clearance System Model 104 From Hill Rom USR150 REV 3 2007 by Hill Rom Services Inc ALL RIGHTS RESERVED Manufactured by HILL ROM 4349 CORPORATE ROAD CHARLESTON SC 29405 UNITED STATES Authorised European Union Representative HILL ROM SAS B P 14 ZI DU TALHOUET 56330 PLUVIGNER FRANCE TEL 33 0 2 97 50 92 12 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 Third Edition First Printing 2004 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 registered trademark of Hill Rom Services Inc Underwriters Laboratories Inc is a registered trademark of Underwriters Laboratories Inc Velcro is a registered trademark of Velcro Industries BV a Dutch Corporation 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 Hi
14. and Hill Rom Ltd Tel 353 0 1 413 6005 Fax 353 0 1 413 6030 dublin sales hill rom com negra 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 446 0 8 564 353 61 se marketing hill rom com South East Asia Hill Rom Singapore Tel 65 0 6391 1322 Fax 65 0 6391 1324
15. and Mobile RF Communications Equipment and the Model 104 The Vest Airway Clearance System Model 104 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Model 104 can help prevent electromagnetic interference if they maintain the minimum distance between portable and mobile RF communications equipment transmitters and the Model 104 The recommended distances in accordance are shown below Rated Maximum Separation Distance According to the Frequency of the Transmitter Output Power ofthe 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Transmitter ed EN JP ge 25 JP qm ln V E Ei 0 01 W 0 12m 0 12m 0 23 m 0 1 W 0 37m 0 37m 0 74m 1W 12m 12m 23m 10 W 37m 37m 7 4m 100 W 12m 12m 23 m applies For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated with the use of the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz to 800 MHz the separation distance for the higher frequency range NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The Ves t Airway Clearance System Model
16. complete Incomplet Reste Incompleto Unterbrochen XX Min Remain XX min XX Min XX Minuten rest rimanenti Session Session Sessione Anwendung Complete complete completata komplett Device Error X Erreur Mat riel Errore sistema X Geratefehler X N X Please Call For Contact Service Per favore Service Service Client chiamare per erforderlich assistenza Display Message Dutch Spanish Swedish Total Use Totaal gebruik Total Uso Total tid XXXX X Hours XXXX X uur XXXX X Horas XXXX X timmar Incomplete Incompleet XX Incompleto Ej klar XX min XX Min Remain min resteren XX Min aterstar Restantes Session Sessie compleet Sesion Behandling klar Complete completada Device Error X Materiaal Error de Enhetsfel X dispositivo X Please Call For Service Bel voor service AUB Llame al servicio Tecnico Kontakta service The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 47 48 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 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 NS Hill Rom Shanghai Tel 86 0 21 5396 6933 Fax 86 0 21 5383 3136 France Hill Rom S
17. cycles cycles lt 5 UT lt 5 UT 79595 dip in 79596 dip in Ur for 5 UT for 5 seconds seconds Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz magnetic field IEC 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Up is the AC mains voltage prior to application of the test level The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 21 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Vest Airway Clearance System Model 104 is intended for use in the electromagnetic environment specified below The customer or user of the Model 104 should make sure it is used in such an environment I it TEC 60601 li EH SH Compuance Electromagnetic Environment Guidance Test Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Model 104 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3V 3 5 IEC 61000 4 6 150 kHz to d Ka JP 80 MHz Radiated RF 3 V m 3 V m 3 5 80 MHz to IEC 61000 4 3 80 MHz to d Ed JP 800 MHz 2 5 GHz _ 77 800 MHz to d BH 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufac
18. from the Air Hose ports on the inflatable vest 11 For a unit in the home care environment do one of these after therapy e Full Vest disconnect the front connectors and remove the inflatable vest Chest Vest disconnect both back panel tabs from the main hook and loop connector and lift the inflatable vest over the head or If the Chest Vest can not be lifted over the head disconnect one of the shoulder straps and back panel tabs and remove the inflatable vest NOTE If a shoulder strap on a Chest Vest is disconnected the inflatable vest will have to be adjusted when it is next used or 36 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 For a unit in the acute care environment do as follows after each therapy a Remove the diaposable vest from the patient A WARNING To help prevent cross contamination replace the single patient use disposable vest between patients Failure to do so could cause patient injury or equipment damage b Ifone of these occurs discard the diaposable vest Airway Clearance Therapy is no longer necessary for the patient The diaposable vest is damaged e The diaposable vest is excessively soiled The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 37 Maintenance A WARNING Only authorized persons should service The Vest Airway Clearance System Model 104 Service by unauthorized persons could cause pers
19. h 4 A 5 x 20 mm Littelfuse part number FAAL250V Condition Temperature Environmental Conditions for Transport and Storage Range 40 F to 158 F 40 C to 70 C Relative humidity 95 non condensing Atmospheric pressure 500 hPa to 1060 hPa Environmental Conditions for Use Condition Temperature Range 50 F to 93 F 10 C to 34 C ambient temperature Relative humidity range Atmospheric pressure 30 to 75 non condensing 700 hPa to 1060 hPa 18 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 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 BF with type F applied Shock part Classification According to Directive IIa 93 42 EEC Degree of Protection Against Ingress of IPX 0 Water The Vest Airway Clearance System Model 104 is a continuous operation device classified with Underwriters Laboratories Inc UL in the United States and licensed with Health Canada 1 Underwriters Laboratories Inc is a registered trademark of Underwriters Laboratories Inc The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 19 Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding electromagnetic compat
20. ibility and needs to be installed and put into service according to the information provided in these tables Portable and mobile radio frequency RF communications equipment can affect medical electrical equipment Guidance and Manufacturer s Declaration Electromagnetic Emissions The Vest Airway Clearance System Model 104 is intended for use in the electromagnetic environment specified below The customer or user of the Model 104 should make sure it is used in such an environment flicker emissions IEC 61000 3 3 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The Model 104 uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Model 104 is suitable for use in all CISPR 11 establishments including domestic Harmonic emissions Class A establishments and those directly connected to IEC 61000 3 2 the public low voltage power supply network Voltage fluctuations Complies that supplies buildings used for domestic purposes 20 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Vest Airway Clearance System Model 104 is intended for use in the electromagnetic environment specified below The customer or user of
21. ll Rom reserves the right to make changes without notice in design specifications and models The only warranty Hill Rom makes is the express written warranty extended on the sale or rental of its products The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 To order additional copies of this manual USR150 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 1 November 2004 2 All September 2005 All September 2007 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Table of Contents Document Symbols 1 Safety KEE 2 Contraindications iles ene 5 Relative Contraindications 00 c eee eee eee 5 GCaNIT OS ae dE Ee we tetas 7 General Cleaning 8 Home Care Environment 8 Acute Care Environment 8 Steam Cleaning eese 9 Cleaning Hard to Clean Spots 9 Disintectilig 5 oV ee UEM 9 Intended Use 1 55 REIR ELE ERR ERREUR 9 T trod ction ee mr epe e Te dE d 11 Eeatures usto EP ss piers E E ie A pertes 12 Air Pulse Generator 2 0 eee eee eee 12 Adr Outlets EE 12 Display and Controls 0 0 0 e ee eee eee 12 Remo
22. lure to do so could cause in the build up of residue or equipment damage Bleach based disinfectants Quarternary ammonium based disinfectant cleaner General Cleaning Home Care Environment We recommend that you clean the Air Pulse Generator and inflatable vest with a soft cotton cleaning pad that is slightly moist from detergent and warm water Do not use excessive liquid or harsh cleansers Do not put The Vest Airway Clearance System Model 104 in water or let liquids enter the Air Pulse Generator After you clean the system wipe it dry Acute Care Environment AA WARNING To help prevent cross contamination replace the single patient use inflatable vest and Air Hoses between patients Failure to do so could cause patient injury or equipment damage NOTE In the Acute Care environment the inflatable vests and Air Hoses are single patient use latex free disposable products for use on individual patients over multiple treatment sessions Clean The Vest Airway Clearance System Model 104 between patients or when visibly soiled 1f used on the same patient Replace the inflatable vest and Air Hoses between patients or when it is damaged 8 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 We recommend that you clean the Air Pulse Generator and Remote Control with a soft cotton cleaning pad that is slightly moist from detergent and warm water Do not use excessive liquid or harsh cleansers
23. neous pacemaker Hemodynamic instability Suspected pulmonary tuberculosis Lung contusion Bronchospasm Osteoporosis or osteomyelitis of the ribs Coagulopathy Complaint of chest wall pain The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Cleaning A WARNING E 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 electrical use protocols may cause death or serious personal injury 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 Personal injury or equipment damage could occur A CAUTION Do not use harsh cleansers solvents or detergents Equipment damage could occur The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 7 The Vest Airway Clearance System Model 104 has been tested for compatibility with these detergents A CAUTION Frequent exposure to phenol based germicidal detergent may discolor the Air Pulse Generator Phenol based germicidal detergent Alcohol based disinfectants A CAUTION If you use bleach based NaOCl disinfectants or quarternary ammonium based disinfectant cleaners make sure you wipe the unit dry Fai
24. odel 104 User Manual USR150 REV 3 13 Inflatable Vests For use in the home care environment these reusable inflatable vests are available in several standard sizes of these two types Chest Vest Full Vest a om px ect es For use in an acute care facility these disposable single patient use inflatable vests are available in several standard sizes of these two types Wrap SPU Vest Full SPU Vest Disposable Wrap SPU Vest Disposable Full SPU Vest 14 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 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 lt gt ON ON control starts the Air Pulse Generator OFF V OFF control stops the Air Pulse Generator Frequency setting Pressure setting treatment Time setting The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 15 Symbol Hes Definition Up arrow control increases the Frequency Pressure or treatment Time setting PW Down arrow control decreases the Frequency Pressure or treatment Time set ting Remote Control port JN Attention Consult accompanying documents Class II equipment double insulated according to EN60601 1 IPX
25. onal injury or equipment damage Minimal routine maintenance is necessary for The Vest Airway Clearance System Model 104 Periodic cleaning is necessary see Cleaning on page 7 If service is necessary on The Vest Airway Clearance System Model 104 call Hill Rom Technical Support For contact information refer to the back cover Professional healthcare facilities should do these examinations and safety tests annually SHOCK HAZARD Unplug the unit from its power source Failure to do so could cause personal injury or equipment damage 1 Unplug the Air Pulse Generator from its power source 2 Examine The Vest Airway Clearance System Model 104 for damaged or lost parts 3 Examine the Power Cord and connectors for cuts scrapes or other damage 4 Do electrical safety tests in accordance with IEC 60601 5 Connect the Air Pulse Generator to the inflatable vest and to the power supply Make sure the The Vest Airway Clearance System Model 104 and all functions operate correctly 6 Clean and disinfect the The Vest Clearance System Model 104 see Cleaning on page 7 7 Putalabelon the Air Pulse Generator that shows this data Tested by e Date e Result of the examination and test 38 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Service Calls When you contact Hill Rom about The Vest Airway Clearance System Model 104 be prepared to give the serial numbe
26. otherapy 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 Model 104 effectively treat all areas of the lungs Yes Since the system oscillates the chest wall to create airflow it applies percussion to all lung areas to effectively treat all lobes of the lung at once How long should each 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 Refer to the physician s orders How often should treatment sessions be given The Frequency of treatment sessions depends on the patient s underlying disease age and state of health The patient s physician will prescribe a schedule for the individual patient schest physiotherapy still necessary Ina number of studies The Vest Airway Clearance System Model 104 has been shown to supply more effective Airway Clearance Therapy than conventional chest physiotherapy Typically it is not necessary to do chest physiotherapy along with therapy treatment sessions with The Vest Airway Clearance System Model 104 s postural drainage still necessary The 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
27. quipment damage could occur Before you clean the system unplug it from its power source Failure to do so could cause personal injury or equipment damage Do not expose the system to excessive moisture or immerse it in water Personal injury or equipment damage could occur Do not operate the Air Pulse Generator without the inflatable vest and Air Hoses attached Equipment damage could occur fitis difficult to connect the Air Hose to the Air Pulse Generator or inflatable vest do not use lubricant Equipment damage could occur e fitis difficult to connect the Remote Control to the Air Pulse Generator do not use lubricant Equipment damage could occur Do not use harsh cleansers solvents or detergents Equipment damage could occur Frequent exposure to phenol based germicidal detergent may discolor the Air Pulse Generator f you use bleach based NaOCT disinfectants or quarternary ammonium based disinfectant cleaners make sure you wipe the unit dry Failure to do so could cause the build up of residue or equipment damage fshipping is necessary the original packing material is designed to protect the unit during shipment Keep the original packing material so it can be used if it is necessary to ship the system KEEP THESE INSTRUCTIONS The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Contraindications A WARNING If the patient has a condition that prevents the use
28. r from the product identification label The product identification label is on the back of the Air Pulse Generator The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 39 Replacement Parts Reusable Chest Vest Home Care Environment Part Number P300230000 Description Small 28 to 35 71 cm to 89 cm P300231000 Medium gt 35 to 46 89 cm to 117 cm P300232000 Large gt 46 to 61 117 cm to 155 cm P300233000 Extra large gt 61 to 67 155 cm to 170 cm Reusable Full Vest Home Care Environment Part Number Description P300282001 Child Medium 23 to 27 58 cm to 69 cm P300284001 Child Large gt 27 to 31 69 cm to 79 cm P300286001 Adult Small 231 to 36 79 cm to 91 cm P300288001 Adult Medium gt 36 to 45 91 cm to 114 cm P300290001 Adult Large gt 45 to 52 114 cm to 132 cm Single Patient Use Disposable Wrap SPU Vest Acute Care Environment Part Number Description P300630005 Small Package of 5 23 to 33 58 cm to 84 cm P300631005 Medium Package of 5 gt 33 to 43 84 cm to 109 cm P300632005 Large Package of 5 743 to 53 109 cm to 135 cm P300633005 Extra Large Package of 5 gt 53 to 67 135 cm to 170 cm The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Single Patient Use Disposable Full SPU Vest Acute Care Environment Pa
29. rescribed treatment session Frequency shows on the display The Frequency or Hertz Hz may be set between 5 and 20 cycles per second b To adjust the Pressure setting press the middle Up and Down arrow controls until EE E the prescribed treatment session Pressure shows on the display The Pressure may be 6 set between 1 and 10 PAN MT c To adjust the treatment Time press the right hand Up and Down arrow controls until the prescribed treatment Time shows on the display The treatment session Time may be set between and 60 minutes NOTE It is not necessary to stop the treatment session to adjust the settings 34 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 4 To begin the treatment session press the ON control The remaining treatment Time shows as it counts down to zero or If you use the optional Remote Control do as follows a Make sure the Remote Control is plugged into the Remote Control port on the front of the Air Pulse Generator b Press and release the Remote Control Four seconds after the Remote Control is first pressed the inflatable vest inflates and automatically begins the treatment session 5 Ifit is necessary to temporarily stop the treatment session do as follows a Press the ON control or Remote Control once The unit will stop the pulsations but the display will continue to show the settings b
30. rt Number Description P300200000 Child Medium 23 to 27 58 cm to 69 cm P300205000 Child Large 727 to 31 69 cm to 79 cm P300210000 Adult Small 231 to 36 79 cm to 91 cm P300215000 Adult Medium 36 to 45 91 cm to 114 cm P300220000 Adult Large gt 45 to 52 114 cm to 132 cm The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 41 Troubleshooting AA WARNING Only authorized persons should service The Vest Airway Clearance System Model 104 Service by unauthorized persons could cause personal injury or equipment damage If service is necessary on The Vest Airway Clearance System Model 104 call Hill Rom Technical Support For contact information refer to the back cover Air Pulse Generator Does Not Power On l 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 If the problem is not corrected call Hill Rom Technical Support For contact information refer to the back cover Inflatable Vest No Longer Fits Home Care Environment I Adjust the inflatable vest to adapt to normal growth see Put on the Inflatable Vest on page 29 If the problem is not corrected call Hill Rom Technical Suppor
31. t For contact information refer to the back cover No Air Pulses into the Inflatable Vest l If the Remote Control is in use make sure it is firmly connected to the Remote Control port on the front panel of the Air Pulse Generator Make sure the Air Hoses are connected to the inflatable vest and Air Pulse Generator If the problem is not corrected call Hill Rom Technical Support For contact information refer to the back cover 42 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Display Alternates between Please Call for Service and Device Error X Messages The system has experienced an unexpected user input or the blower motor or diaphragm motor failed Do as follows 1 Unplug the Power Cord from the Air Pulse Generator and then plug it in again DEVICE ERROR X PN ESAE Kees ID e 8N PLEASE CALL FOR SERVICE ler J Ea SENEC TOS OVUNQUE JM Es a E ALL MEL d 2 Ifthe problem is not corrected call Hill Rom Technical Support 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 Hose from the Air Pulse Generator and the inflatable vest 2 Clean the inside and outside of these see Cleaning on page 7 e Ends of
32. t Vest slide the end of each Air Hose into the inflatable vest Air Hose ports To help keep the Air Hoses in position slightly twist the Air Hoses as you push them in the inflatable vest Air Hose ports Disposable Wrap SUP Vest slide the end of each Air Hose into the disposable vest Air Hose slits and then use the Velcro loops to hold the Air Hoses in position E 1 Velcro is a registered trademark of Velcro Industries BV a Dutch Corporation The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 27 A CAUTION If it is difficult to connect the Remote Control to the Air Pulse Generator do not use lubricant Equipment damage could occur 8 If the optional Remote Control is to be used instead of the ON control plug the Remote Control into the Remote Control port on the front of the Air Pulse Generator If it is difficult to connect the Remote Control to the Air Pulse Generator do not use lubricant 28 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Put on the Inflatable Vest NOTE For comfort a single layer of cotton clothing should be worn under the inflatable vest The inflatable vest should be adjusted so that it is comfortable Reusable Chest Vest Home Care Environment 1 Pull the back panel tabs from the main hook and loop fastener and separate the front and back panels of the inflatable vest T
33. te Control and Air Hoses 00 2000s 13 Power Gord sient ee hulk ahi te leis taeda ss 13 Inflatable Vests Zeg Sot sh ead ia sie as ages ot 14 Product Symbols 15 Specifications eos rre eee cin er Peete 18 Classification and Standards 19 Electromagnetic Compatibility 000 20 Instructions for Use eg etr DER ree eT qs 24 Protocol for Use and Special Instructions for the Home Care Patient 0 2 eee eee eee 24 Set Up the Unit 2 cic a n E Sere es 25 Put on the Inflatable Vest 0 0 00 eee eee ee 29 Reusable Chest Vest Home Care Environment 29 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 iii Reusable Full Vest Home Care Environment Disposable Wrap SPU Vest Acute Care Environment Disposable Full SPU Vest Acute Care Environment Use The Vest Airway Clearance System Model TUE ose a iA a EE E Maintenance 2 ee tac ase EE Shy hota tee bees Service Calls ert ack wey aes SNA Nae edo Replacement Parts 5 eee done ees Troubleshooting Air Pulse Generator Does Not Power On Inflatable Vest No Longer Fits Home Care Environment 2 0 00 ee eee eee No Air Pulses into the Inflatable Vest Display Alternates between Please Call for Service and Device Error X Messages An Air Hose Comes Out of the Air Pulse Generator or Inflatable Vest during Operation S
34. the Model 104 should make sure it is used in such an environment Immunity TEC 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 6 kV air 6 kV air with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for 2 kV for Mains power quality should be that transient burst power supply power supply ofa typical commercial or hospital IEC 61000 4 4 lines lines environment kV for kV for input output input output lines lines Surge 1 kV 1kV Mains power quality should be that IEC 61000 4 5 differential differential of a typical commercial or hospital mode mode environment x 2 kV SES 2 kV common common mode mode Voltage dips short lt 5 UT lt 5 UT Mains power quality should be that interruptions and 29596 dip in gt 95 dip in of a typical commercial or hospital voltage variations Ur for 0 5 UT 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 104 during power TEC 61000 4 11 40 UT 40 UT mains interruptions it is 60 dipin 60 dipin recommended that the Model 104 be UT for 5 UT for 5 powered from an uninterruptible cycles cycles power supply or a battery 70 UT 70 UT 30 dip in 30 dip in UT for 25 UT for 25
35. tly lift the back of the buckle and lengthen the strap 5 Iftoo much inflatable vest material is under the front connectors fold the material under itself to make sure the fit is correct a Loosen the front connectors b Fold the top of the material under itself c Tighten the front connectors The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 31 Disposable Wrap SPU Vest Acute Care Environment I 2 Turn the patient towards you With the disposable vest deflated begin to lay it flat on the bed so it is perpendicular with the patient s torso Roll the patient away from you and on the open portion of the Wrap SPU Vest Put the Wrap SPU Vest in position just beneath the patient s underarms and continue to pull the Wrap SPU Vest around the patient s torso Roll the patient to a supine position Pull both ends of the Wrap SPU Vest around the patient s chest and use the Velcro fasteners to temporarily attach both ends to each other Have the patient inhale deeply and then attach the ends of the Wrap SPU Vest so it fits close to the body but is not uncomfortable 1 Velcro is a registered trademark of Velcro Industries BV a Dutch Corporation 32 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Disposable Full SPU Vest Acute Care Environment 1 Separate the front flaps of the disposable vest at the Velcro
36. torage and Handling 0 0 eee eee ee ene Storage Bag Home Care Environment Shipping the Unit Frequently Asked Questions Display Messages The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 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 emphasises a word or phrase 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 ACAUTION identifies special procedures or precautions that persons must obey to help prevent equipment damage ELECTRICAL SHOCK HAZARD WARNING The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 1 Safety Tips When you use electrical products always obey safety precautions and these important safety tips READ ALL INSTRUCTIONS BEFORE PRODUCT USE A WARNING To reduce the risk of electrocution obey these instructions Failure to do so could cause personal injury or equipment damage Unplug this system immediately after you use it A WARNING Do not use the system near flammable anaesthetics To do so could cause personal injury or equipment damage Do
37. tructions for setup use and maintenance of the unit Failure to do so could cause patient injury or equipment damage fthe patient has a condition that prevents the use of the unit do not use the system Death or serious injury could occur 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 may cause patient injury To help prevent cross contamination replace the single patient use inflatable vest between patients Failure to do so could cause patient injury or equipment damage Only authorized persons should service the unit Service by unauthorized persons could cause personal injury or equipment damage The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 3 NOTE 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 The potential for electrical shock exists with electrical equipment Failure to follow electrical use protocols may cause death or serious personal injury Ifthe 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 Use a known good electrical outlet only Do not use the Air Pulse Generator with an extension cord or multiple use electrical outlet adapter Death serious injury or e
38. turer and d is the recommended separation distance in metres m 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 Dei 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 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 cannot 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 104 is used is more than the applicable RF compliance level above the Model 104 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 104 s position or location b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 22 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Recommended Separation Distances Between Portable
39. urn the inflatable vest so the Air Hose ports are in front Slide the inflatable vest over the head With the inflatable vest deflated temporarily attach both back panel tabs of the inflatable vest to the front panel Adjust the hook and loop fasteners on the shoulder straps so the bottom of each arm opening is comfortably close to the underarm Pull both back panel tabs from the front of the inflatable vest For the best fit inhale deeply and then attach both back panel tabs to the front panel The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 29 8 Make sure the inflatable vest is close to the body but not uncomfortably tight To tighten the fit at the bottom edge angle the back panel tabs upward e To loosen the fit at the bottom edge angle the back panel tabs downward 30 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Reusable Full Vest Home Care Environment 1 Put the Full Vest on so its connectors are in front 2 Attach the connectors so the inflatable vest is loose over the chest 3 Use the shoulder straps to adjust the length of the inflatable vest so the bottom edge is level with the top of the hip bone 4 Use the front connectors to adjust the inflatable vest to be close to the body but not uncomfortable Tighten hold the buckle and pull the end of the strap to the patient s right Loosen gen
40. way Clearance System Model 104 User Manual USR150 REV 3 9 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 Model 104 as prescribed by your physician 10 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 Introduction Hil Rom J The Vest Airway Clearance System Model 104 was developed to help supply effective Airway Clearance Therapy The system 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 which creates 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 The Ves t Airway Clearance System Model 104 User Manual USR150 REV 3 11 LH Features Air Pulse Generator When correctly connected the Air Pulse Generator controls the inflatable vest and supplies pulsations to the chest wall Air Air Outlets outlets 2 Air Hoses connect at the two air outlets on the front of the Air Pulse Generator Display and Controls
Download Pdf Manuals
Related Search