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Electro Flo® 5000 Airway Clearance System

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1. P N 5011 V 11 12 13 a Electro Flo 5000 User Manual Self Administrator Strap Setup e When using the Self Administrator Strap place it on a flat surface with the opening toward you and the Med Systems logo away from you f Open the Velcro closure and insert the Electro Flo 5000 Power Head as shown Placing the bottom of the Power Head in first will help with insertion It willbe a snug fit g Tighten the Velcro closure securely A CAUTION The cooling fan must be running to ensure successful cooling of the percussor Power Head If the cooling fan is not operating unplug and contact MED SYSTEMS for repair P N 5011 V 11 12 13 12 Electro Flo 5000 User Manual Step 2 Treatment serie Do not percuss over bare skin Do not percuss directly on the shoulder blade collar bone spine breast bone sternum or breasts Do not place Self Administrator over head or around neck a At this time the patient may assume a postural drainage position Techniques and settings may vary with each treatment Follow Postural Drainage Therapy guidelines as directed by your physician b Turn on Unit Press the upper part of the switch on the back of the Control Box to turn the unit ON The green indicator light will come on the Control Panel showing power is on and the fan is running The unit may cycle once This is normal c The blue indicator light for spe
2. The Electro Flo 5000 has no user serviceable parts contact MED SYSTEMS if it appears to be malfunctioning 1 DO NOT DISASSEMBLE THE UNIT AT ANY TIME 2 Any unit needing repair must be returned to MED SYSTEMS directly Return any unit for repair which does not o Cycle o Have a running fan o Show a green light while plugged in and the power is switch on o Show a blinking blue light when power is turned above the Stand By position o Have percussive action with a blinking blue light and running fan 3 For any of the above criteria please contact MED SYSTEM Customer Service for processing your return at the following numbers U S Toll Free 800 345 9061 Outside U S 858 483 9671 4 MED SYSTEMS will ship a loaner unit to you 5 Carefully pack the percussor that you are returning in the box provided 6 Product exchange instructions will be included with the loaner unit P N 5011 20 Electro Flo 5000 User Manual EEE Warranty Electro Flo 5000 amp Self Administrator MED SYSTEMS warrants the products against defective materials or workmanship for three years from date of purchase MED SYSTEMS shall replace or repair any product deemed defective upon receipt of written claim of defect at its option The user of this product shall have the sole responsibility for any malfunction which results from improper use Note This warranty does not cover ordinary wear and tear arising from the normal u
3. out of the reach of children Do not use the Electro Flo 5000 with or in water Do not use near flammable anesthetics or near fire A CAUTION P N 5011 V 11 12 13 Electro Floe 5000 is a prescription restricted device intended for the person for whom it was ordered and only for the use for which it was intended Never immerse the unit in any liquid Product is to be used only as described in this manual and only as prescribed by a physician Inspect power cord and unit prior to use Do not use this product if any damage has occurred to power cord or any part of the system Do NOT insert any object into any opening on the system Always observe ALL warnings cautions and notes listed in this manual Electro Flo 5000 User Manual EEE Er Electro Floe 5000 System Description The Electro Floe 5000 System is composed of the following assemblies Control Box Power Head Self Administrator Strap Carrying Case Operator Manual The power and speed of the percussor may be increased by turning the knobs clockwise There are 5 power settings and 6 speed controls making 30 combinations available for individual percussive needs Ras Sees ELECTRO FLO FPERCUSSOR NDOBL sooo Vo Electro Flo 5000 Control Box and Power Head There is a 10 foot power cord to connect the Control Box to an outlet and a 6 foot cord between the Control Box and the Power Head P N 5011 V 11 12 13 8 Elec
4. MEDSYSTEMS N 7 Electro Flo 5000 Airway Clearance System User Manual www medsystems com Rx only Patents Pending Made in U S P N 5011 V 11 12 13 Electro Flo 5000 User Manual Page Intentionally Left Blank P N 5011 V 11 12 13 Electro Flo 5000 User Manual TE ZA Read this guide completely before using your Electro Flo 5000 System Table of Contents Definitions PEN E T E E E E 4 How does the Electro Flo 5000 work sssseesssssssseeeesssssssen 5 The BlectroF 05 ya ae 5 indications TOM se 6 Contraindications zn 6 SALELVINSTLUCLON ee 7 Electro Flo 5000 System Description cuesneseeesesseesneneeenenen 8 Self Administrator Personalized CPT c ccsssssseseseseeeeeees 10 Operating Instructions cccceecseccsccsececcseceeccueesecesceseeseees 11 STEH Le E o ae een ee ee er er ree re 11 Step 2 TreatMent scscsarcwssveaceoneencumsinmsctanestenmerscanomantennven 13 Step 3 SNUTGOW re ee ei 17 Cleaning INSTFUCTIONS cccccccssecccesececeesceeceseeeeeeecesseeeeeeees 18 AEE DELE E T ae re een 19 RODA See ee E EE E 20 WY I a eek 21 Operating EnvironmMent ssssessesessesesrrsesresessesesseserseseeseeses 22 PEIE ITO ee ee ae T 22 Federal law restricts this device to be sold by or on the order of a physician or on the order of a licensed practitioner P N 5014 V 14 12 13 3 Electro Flo 5000 User Manual Definitions This manual contains words and symbols that b
5. P N 5011 V 11 12 13 22 Electro Flo 5000 User Manual Page Intentionally Left Blank P N 5011 V 11 12 13 a MEDSYSTEMS 2631 Ariane Drive San Diego CA 92117 USA U S Toll Free 800 345 9061 Office 858 483 9671 Fax 858 483 9827 www medsystems com P N 5011 V 11 12 13
6. ed mon DO NOT spray disinfectant on the Control Box and Power Head this can cause fluid ingress and damage the system A CAUTION DO NOT autoclave DO NOT gas sterilize with ETO DO NOT clean with aromatic hydrocarbons Self Administrator To disinfect use an alcohol pad or disinfectant wipe Clean by wiping down with cool water and mild detergent or hand wash and allow to air dry out of direct sunlight Clean Velcro area on straps using a comb or brush to remove any debris or dirty from the Velcro Carrying Case Clean by wiping down with a cool water and mild detergent or disinfectant wipe Allow to air dry out of direct sunlight A caution DO NOT use bleach on fabric P N 5011 V 11 12 13 o Electro Flo 5000 User Manual Maintenance 1 The percussor cooling fan draws in 4 cubic feet per minute of air Therefore considerable dust and lint can be drawn into the percussor filter Amon If the percussor filter becomes clogged with lint deposits the unit will shut off permanently Inspect the percussion fan vent regularly Use compressed canned air once a month or as needed to clean and remove lint from the fan located in the Power Head Spray air onto the fan opening following usage directions on the can caunon Do not insert extension tube into the opening as is it might damage the fan P N 5011 V 11 12 13 gh Electro Flo 5000 User Manual EEE ZH FEED Repairs NOTE
7. ed will be OFF and there will be no percussive action P N 5011 V 11 12 13 o B Electro Flo 5000 User Manual EE O o d Start at the lowest settings of power and speed as shown by the lines on the knobs e To achieve percussive action turn the power knob one step from Stand By to 1 This will begin low power slow speed percussive action The blue light will blink at the speed rate of percussion SPEED f Adjust the Electro Flo 5000 Control Panel s power and speed settings to desired positions g Pressing against area being treated while applying pressure to the top cover will multiply the applied force and intensify the treatment Electro Flo s Force Multiplying Technology is activated when pressure is applied onto the top of the Power Head cover P N 5011 V 11 12 13 14 Electro Flo 5000 User Manual A CAUTION h Treat each area to be j Percussion should not hurt If it does STOP Reduce the pressure applied to the rear cover and or reduce the power setting on the Control Box Do not block the fan vent with your hand or fingers drained for approximately 3 minutes You may use the Self Administrator to reach lobes on the back or front You can leave the Power Head in the Self Administrator to easily apply to the front of the chest Take deep breaths throughout the treatment Coughing is a normal result and a benefit of percussion Limit percussion t
8. o 20 minutes maximum per session to avoid overheating the system P N 5011 V 11 12 13 a Electro Flo 5000 User Manual k Positioning the Power Head firmly between your back and a desk chair allows for a hands free treatment NOTE If the Power Head slips out of the Self Administrator during treatment pulling the straps toward the chest will correct its position canon Avoid using the unit in a dusty environment or laying the Power Head on a blanket as the lint from the blanket may be drawn in by the fan and damage the unit P N 5011 16 Electro Flo 5000 User Manual a a n a n Step 3 Shutdown a After use turn the power knob counter clockwise to the Stand by position This will stop percussion and cycling power but allow the unit to cool with the fan running b If using the Self Administrator remove the Power Head from the strap and place it on a lint free surface for COOL DOWN A CAUTION Do not unplug or switch off the unit until COOL DOWN is complete c To turn off the unit press the lower half of the power switch The GREEN LED will turn off and the fan will stop Unplug the power cord from the outlet P N 5011 V 11 12 13 17 Electro Flo 5000 User Manual Cleaning Instructions Control Box and Power Head While system is turned off and unplugged wipe the outside of the Power Head and Control Box using an isopropyl alcohol IPA wipe or a disinfecting wipe as need
9. ring attention to specific statements VARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury or failure or damage of the device P N 5011 V 11 12 13 4 Electro Flo 5000 User Manual EEE Er How does the Electro Flo 5000 work Percussion has long been held as the best method for loosening trapped mucus within the lungs Historically the first and still the most effective percussion method used for respiratory therapy is the rhythmic striking with human hands on the chest wall The MED SYSTEMS Electro Flo 5000 with Force Multiplying Technology tirelessly mimics hand percussion without user fatigue Airway Clearance Therapy ACT loosens thick sticky mucus so that it may be cleared by huffing and coughing Gravity helps to ensure effective outcomes so use postural drainage positions to aid in moving mucus from the lungs up to the throat The Electro Flo 5000 Is designed for convenient personalized Chest Physiotherapy CPT May be self administered over individual lobes s automated consistent true percussion not massage Precisely controls power and frequency of percussion separately Varies from light tapping to major impact Delivers deep pulse percussion Is light weight compact and portable Will quickly and easil
10. se of the product The user of this product shall have the sole responsibility for any malfunction which results from improper use The following conditions will cause the warranty to be null and void Plugging the unit into an outlet that supplies more than 120 VAC Submersing the unit in water Operating the unit in an environment outside the specifications Disassembling the unit in any way Any maintenance performed outside the factory The foregoing warranty is in lieu of all other warranties whether expressed or implied including but not limited to any warranty of merchantability of fitness for a particular purpose not existing in connection with sale or use of this product P N 5011 V 11 12 13 a Electro Flo 5000 User Manual DEE Operating Environment Operating Temperature 50 F to 95 F 10 C to 35 C Storage amp Transport ee Temperature 32 F to 158 F 0 C to 70 C Relative Humidity MAX 95 Non Condensing Specifications Product Type Medical Chest Percussor yP Durable Medical Equipment B EEE Type BF Patient Electrical Classification se ROE J R Duty Cycle 20 minutes on 20 minutes off Information Regulatory CLASS II Electrical System Medical Equipment with respect to Electric Shock l canteen TO Fire and Mechanical Hazards I ee l UL STD 60601 1 only in accordance with Intertek UL60601 1 CAN CSA C22 2 4001061 CERTIFIED TO NO 601 1 CAN CSA C22 2 STD NO 601 1
11. tro Flo 5000 User Manual POWER PR SPEED 00o 9996 1 ud 5 Ja 1 Orast Electro Flo 5000 Control Panel Green Light POWER ON Blue Light SPEED RATE The power switch is located on the back of the unit on the lower right side ON and OFF Switch P N 5011 V 11 12 13 g Electro Flo 5000 User Manual Self Administrator Personalized CPT The Self Administrator is a strap that holds the Electro Flo 5000 Power Head to allow a patient to CPT directly on their back unassisted and precisely where needed for immediate relief The Self Administrator The Self Administrator can be used by anyone with manual dexterity It has adjustable straps that can be adjusted to fit anyone s reach and for the treatment position being used Adjusta ble Stra ps Refer to MED SYSTEMS website for a demonstrational video of percussion treatment with the Self Administrator P N 5011 10 Electro Flo 5000 User Manual Bere EEE Operating Instructions Step 1 Setup a Begin by gathering all necessary materials such as tissues pillows and towels b Remove equipment from carrying case and set up on a stable horizontal surface c Before plugging the unit in fully turn both knobs counter clockwise on the Control Panel POWER SPEED CORD TO 895 Y 999 5 N C 5 AT 1 C 6 IES d Plug the unit DIRECTLY into a properly grounded three pronged 120 volt electrical outlet
12. y help increase sputum mobilization P N 5011 V 11 12 13 5 Electro Flo 5000 User Manual BEE Indications for Use The Electro Flo 5000 is intended to assist in airway clearance therapy when the physician s choice of therapy is external manipulation of the thorax Additionally the Electro Flos 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage Contraindications The Electro Flo 5000 is not intended for infants or children less than 50 Ibs The Electro Flo 5000 should not be used on patients who have severe calcium deficiencies or severe osteoporosis mon The Electro Flo 5000 should not be used on patients who Have just eaten or are vomiting Have acute asthma or tuberculosis Have brittle bones broken ribs or severe osteoporosis Are bleeding from the lungs or coughing up blood Are experiencing intense pain Have increased pressure in the skull Have head or neck injuries Have collapsed lungs or a damaged chest wall Have recently experienced a heart attack Have a pulmonary embolism or lung abscess Have an active hemorrhage Have injuries to the spine Have open wounds or burns Have had recent surgery P N 5014 V 11 12 13 a 6 Electro Flo 5000 User Manual Safety Instructions A WARNING To reduce the risk of electrocution fire or personal injury follow these instructions Keep this device

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