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Summary of Contents for Electromed SmartVest SV2100
- Page 1 http://waterheatertimer.org/COPD-exercises.html ModelSV2100/SV2100-I Instruction Manual 070098-S-010 Rev N www.SmartVest.com...
- Page 3 Service Representative: 888-966-2525 Model SV2100/SV2100-I Instruction Manual 070098-S-010 Rev N © 2013 Electromed, Inc.
- Page 5 System use. Electromed, Inc. welcomes feedback on methods for improving the quality of our products and service. Whether this feedback is regarding information presented in this Manual, the operation of the System itself, or any other matter, we truly appreciate your input.
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Page 6: Table Of Contents
SmartVest Airway Clearance System Table of Contents ® What is High Frequency Chest Wall Oscillation (HFCWO)? ........1 Safety ..........................2 Warnings ........................2 Cautions ........................3 Equipment Classifications ..................4 Indications for Use ..................... 5 SmartVest Airway Clearance System ..............5 ®... - Page 7 SmartVest Airway Clearance System Table of Contents ® Wheeled Carrier and Accessory Bag ................18 Institutional Products ..................... 19 Single Patient Use (SPU) SmartVest ..............19 ® Single Patient Use (SPU) SmartVest Wrap ............19 ® SV2100-I and Mobile Pedestal .................. 19 Single Patient Use (SPU) Connecting Hose ............
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Page 9: What Is High Frequency Chest Wall Oscillation (Hfcwo)
SmartVest Airway Clearance System What is HFCWO? ® What is High Frequency Chest Wall Oscillation (HFCWO)? High Frequency Chest Wall Oscillation (HFCWO) has been an effective form of airway clearance therapy for more than 40 years. HFCWO, administered by the patented SmartVest , creates a “squeeze and release”... -
Page 10: Safety
SmartVest Airway Clearance System Safety ® Safety Warnings Attention! Read these Safety Instructions and the entire Instruction Manual before using this device. Consult instructions for use. Follow instructions for use. Dangerous voltage within the device may constitute a risk of electric shock. -
Page 11: Cautions
Do NOT attempt to repair the system yourself. If you experience any problems, contact your Service Representative. Use only compatible SmartVest Airway Clearance System components ® supplied by Electromed, Inc. Do NOT staple, sew, or apply any items to the SmartVest shell that ® could penetrate the inner bladder. -
Page 12: Equipment Classifications
SmartVest Airway Clearance System Safety ® Equipment Classifications Medical equipment with respect to electrical shock, fire and mechanical hazards only in accordance with: IEC 60601-1 (2005); EN 60601-1 (2006); CAN/CSA-C22.2 No. 60601-1 (2008); ANSI/AAMI ES60601-1 (2005); IEC 60601-1 (1988); UL60601-1 The SmartVest Airway Clearance System meets class 1 protection ®... -
Page 13: Indications For Use
Airway Clearance System ® ® Indications for Use Electromed, Inc. has received clearance to market from the FDA for the following indications: “The Electromed, Inc. SmartVest Airway Clearance ® System is designed to deliver High Frequency Chest Wall Oscillation (HFCWO) to promote airway clearance and improve bronchial drainage. -
Page 14: Smartvest ® Garments
SmartVest Airway Clearance System SmartVest Garments ® ® SmartVest Garments ® The SmartVest delivers full coverage air pulses to the front, back, and sides of the ® torso. It is made of a soft, breathable fabric that minimizes perspiration and itching (refer to section on Cleaning the SmartVest ®... -
Page 15: Fitting The Smartvest Wrap
SmartVest Airway Clearance System SmartVest Garments ® ® NOTE: If the front closure opens during treatment, it can be secured by opening the small strap on the left side of the SmartVest , lacing it through the D ring, and securing it with the Velcro-type closure. -
Page 16: Fitting Accessories
SmartVest Airway Clearance System SmartVest Garments ® ® Fitting Accessories Using the SmartVest Extender ® An extender is available for those using an adult size SmartVest and requiring ® additional chest circumference but not additional height. This accessory provides up to an additional 14 inches of chest coverage. Using a Foam Pad If you are experiencing tenderness from a new G-tube or central catheter, your Service Representative can provide you with a foam pad to help protect the... -
Page 17: Reinserting The Inner Bladder
SmartVest Airway Clearance System SmartVest Garments ® ® Reinserting the Inner Bladder NOTE: Prior to inserting the bladder, make sure the outer shell is completely dry. Steps: 1. Lay the outer shell on a flat surface. 2. Open the outer shell completely. 3. -
Page 18: Connecting Hose
SmartVest Airway Clearance System Connecting Hose ® Connecting Hose The single-hose transmits air pulses from the air pulse generator to the SmartVest . The hose connection point is the same on both ends. Therefore, ® whether connecting to the generator or the SmartVest garment, the insertion ®... -
Page 19: Sv2100/Sv2100-I Air Pulse Generator
SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® SV2100/SV2100-I Air Pulse Generator The air pulse generator creates air pulses that are transmitted to the chest via the connecting hose and vest. Its Soft Start technology reduces “squeeze ® effect” and “vest creep” on start-up. CAUTION: Do not start the generator until the hose and SmartVest ®... -
Page 20: Control Panel Overview
SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® Control Panel Overview All treatment sessions begin from the Home screen of the SmartVest Air Pulse ® Generator. The elements of the generator controls are described below. Up and Down Air Pressure Arrows Control Dial Power... -
Page 21: Setting Treatment Protocols
SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® Setting Treatment Protocols The SmartVest System has two operating modes, Manual and Program. ® • In Manual mode you set the prescribed protocol each time you perform a treatment. • In Program mode you can set and save three separate prescribed protocols (PROGRAM 1, PROGRAM 2, and PROGRAM 3). -
Page 22: Setting Program Mode
SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® Setting Program Mode Steps: 1. From the Home screen, press either next to PROGRAM 1, PROGRAM 2, or PROGRAM 3. 2. From the selected PROGRAM mode screen, press to select the first interval of the treatment protocol. - Page 23 SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® 4. Continuing with line A highlighted, use to the right of the display screen to set the required Frequency. NOTE: Frequency is adjustable in 1 Hz increments from 5 to 20 Hz. 5.
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Page 24: Starting The Treatment Protocol
SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® Starting the Treatment Protocol Select the desired treatment protocol from the Home screen and follow the steps below. Steps: 1. Press to begin your treatment interval. • To pause your treatment, press again. -
Page 25: Routine Care Of The Air Pulse Generator
SmartVest Airway Clearance System SV2100/SV2100-I Air Pulse Generator ® Routine Care of the Air Pulse Generator Cleaning the Air Pulse Generator WARNING: Always remove the power cord before cleaning or servicing the air pulse generator. The exterior of the air pulse generator and connecting hose may be cleaned with a damp cloth and a mild household disinfectant. -
Page 26: Wheeled Carrier And Accessory Bag
SmartVest Airway Clearance System Wheeled Carrier and Accessory Bag ® Wheeled Carrier and Accessory Bag The wheeled carrier and accessory bag make transporting your SmartVest ® Airway Clearance System easier. The wheeled carrier case is durable and the generator easily slides in and out, while the telescoping handle adjusts to your height needs. -
Page 27: Institutional Products
SmartVest Airway Clearance System Institutional Products ® Institutional Products The following items are intended to be used only in hospitals and other institutional settings. Single Patient Use (SPU) SmartVest ® The SPU SmartVest is intended for use by a single patient during a hospital or ®... -
Page 28: Troubleshooting
SmartVest Airway Clearance System Troubleshooting ® Troubleshooting In response to various environmental conditions, the generator screen will display an error message. Understanding these messages will help you quickly troubleshoot the problem. If the suggested actions below do not resolve the situation, contact your Service Representative. - Page 29 SmartVest Airway Clearance System Troubleshooting ® At times you may experience additional issues. If the suggested actions below do not resolve the issue, contact your Service Representative. Problem is… Take this action… There is no power to Confirm whether the device is in Sleep mode. the air pulse generator, Is the Power Indicator Light illuminated? or the vest does not...
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Page 30: Specifications
SmartVest Airway Clearance System Specifications ® Specifications Operational Parameters • Time: 0 – 30 minutes ± 2% • Frequency: 5 – 20 Hz ± 1 Hz Air Pulse Generator • Weight: 23 lbs (10.5 kg) • Dimensions: 15 3/4” x 15” x 7 1/4” (40 x 38 x 18.5 cm) Vest(s) Available in eight sizes for long-term and single patient use. -
Page 31: Electromagnetic Compatibility
SmartVest Airway Clearance System Electromagnetic Compatibility ® Electromagnetic Compatibility Guidance and Manufacturer’s Declarations – Electromagnetic Immunity The SmartVest Airway Clearance System Model SV2100/SV2100-I is intended for use in ® the electromagnetic environment specified below. The customer or the user of the Model SV2100/SV2100-I should assure that it is used in such an environment. - Page 32 SmartVest Airway Clearance System Electromagnetic Compatibility ® Guidance and Manufacturer’s Declarations – Electromagnetic Immunity The SmartVest Airway Clearance System Model SV2100/SV2100-I is intended for use ® in the electromagnetic environment specified below. The customer or the user of the Model SV2100/SV2100-I should assure that it is used in such an environment. Immunity IEC 60601 Compliance...
- Page 33 SmartVest Airway Clearance System Electromagnetic Compatibility ® Recommended separation distances between portable and mobile RF communications equipment and the SmartVest Airway Clearance System, Model SV2100/SV2100-I ® The SmartVest Airway Clearance System Model SV2100/SV2100-I is intended ® for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 34: Prescription Record
SmartVest Airway Clearance System Prescription Record ® Prescription Record Airway Clearance System Model SV2100/SV2100-I SmartVest ® Serial # _____________________________ Prescribed Protocols User One ____________ User Two ____________ User Three ____________ Date ________________ Date ________________ Date _________________ ______times/day ______times/day ______times/day ______minutes/treatment ______minutes/treatment ______minutes/treatment ______pressure setting ______pressure setting... - Page 35 Accreditedby TheJointCommission 502 Sixth Avenue NW New Prague, MN 56071 www.Electromed.com MDSSGmbH Made in USA Schiffgraben41 30175Hannover,Germany ISO 13485 / ISO 9001 Certified...
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