Med Systems Electro Flo 5000 User Manual

Electro Flo
®
5000
Airway Clearance System
U.S. Patent No: US 8,777,880 B2
Canadian Patent No: 2,804,531
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User Manual
Rx only
Made in the USA
Electro Flo® 5000 – User Manual
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Electro Flo® 5000 – User Manual
Read this manual completely before using your
Electro Flo® 5000 System
Table of Contents
.
Definitions ..............................................................................4
How does the Electro Flo 5000 work? ...................................5
The Electro Flo 5000 ...............................................................5
Indications for Use .................................................................6
Contraindications ...................................................................6
Safety Instructions .................................................................7
Electro Flo® 5000 System Description ....................................8
Self-Administrator® - Personalized CPT ................................10
Operating Instructions .........................................................11
Step 1 – Setup ......................................................................11
Step 2 – Treatment ..............................................................13
Step 3 – Shutdown ...............................................................17
Cleaning Instructions ............................................................18
Maintenance ........................................................................19
Disposal ................................................................................19
Repairs ..................................................................................20
Warranty ..............................................................................21
Operating Environment........................................................22
Specifications .......................................................................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.
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Electro Flo® 5000 – User Manual

Definitions

This manual contains words and symbols that bring attention to specific statements.
WARNING Indicates a potentially hazardous
situation which, if not avoided, could result in death or serious injury.
CAUTIONIndicates a potentially hazardous
situation which, if not avoided, may result in minor or moderate injury, or failure or damage of the device.
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Electro Flo® 5000 – User Manual

How does the Electro F lo® 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 Electro Flo® 5000 with Force-Multiplying Technology tirelessly mimics hand percussion without user fatigue. The Electro Flo® 5000 System targets and loosens thick, sticky mucus so that it may be cleared by huffing, coughing and/or suction.
Gravity helps ensure effective outcomes by using postural drainage positions to aid in moving mucus from the lungs up to the throat for clearance.

The Electro Flo 5000

Is designed for convenient, personalized Chest
Physiotherapy (CPT)
May be self-administered over individual lobes Is automated, consistent, true percussion, not massage Precisely controls power and frequency of percussion
separately
Varies from light tapping to major impactDelivers deep, pulse percussionIs light weight, compact and portable Will quickly and easily help increase sputum
mobilization
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Electro Flo® 5000 – User Manual

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 Flo 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 lbs.
The Electro Flo 5000 should not be used on patients who
have severe calcium deficiencies or severe osteoporosis.
CAUTION – The Electro Flo 5000 should not be used on
patients who:
Have just eaten or are vomiting Have acute asthma or tuberculosisHave brittle bones, broken ribs or severe
osteoporosis
Are bleeding from the lungs or coughing up blood Are experiencing intense painHave increased pressure in the skullHave head or neck injuriesHave collapsed lungs or a damaged chest wall Have recently experienced a heart attack Have a pulmonary embolism or lung abscess Have an active hemorrhageHave injuries to the spine Have open wounds or burns Have had recent surgery
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Electro Flo® 5000 – User Manual

Safety Instructions

WARNINGTo reduce the risk of electrocution, fire,
or personal injury, follow these instructions:
Keep this device 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.
CAUTION
Electro Flo® 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.
Information regarding potential electromagnetic or
other interferences – If any interferences from a
television, computer, cell phone or other electronic device is experienced, you can move the percussor to another room or location. You can also turn off the device that is interfering with the percussor.
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Electro Flo® 5000 – User Manual
Control Box
Electro Flo
®
5000 System Description
The Electro Flo® 5000 System is composed of the following assemblies:
Power HeadCarrying CaseUser Manual Accessory
Self-Administrator® Strap
The power and speed of percussion may be increased by turning the knobs clockwise. There are 5 power settings and 6 speed settings, making 30 combinations available for individual percussive needs.
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Electro Flo® 5000 – Control Box and Power Head
Electro Flo® 5000 – User Manual
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.
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
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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.
Adjustable Straps
Refer to MED SYSTEMS website for a demonstrational
video of percussion treatment with the Self-Administrator.
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Electro Flo® 5000 – User Manual
c) Before plugging the unit in, fully turn both knobs
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.
counter clockwise on the Control Panel.
d) Unit has a three-
pronged Type B plug. Plug the unit DIRECTLY into a properly grounded three-pronged, 120 Volt, NEMA 5-15, receptacle.
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Self-Administrator Strap
be a snug fit.
The cooling fan must be running to
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 will
Electro Flo® 5000 – User Manual
g) Tighten the Velcro
closure securely.
CAUTION
ensure successful cooling of the percussor Power Head. If the cooling fan is not operating, unplug and contact MED SYSTEMS for repair.
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Electro Flo® 5000 – User Manual
neck.

Step 2 – Treatment

CAUTION
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
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 speed will be OFF and there will be no percussive action.
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Electro Flo® 5000 – User Manual
e) To achieve percussive
positions.
d) Start at the lowest
settings of power and speed as shown by the lines on the knobs.
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.
f) Adjust the Electro Flo
5000 Control Panel’s power and speed settings to desired
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.
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Electro Flo® 5000 – User Manual
Take deep breaths throughout the treatment.
CAUTION
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.
h) Treat each area to be
drained for approximately 3 minutes.
i) You may use the Self-
Administrator to reach lobes on the back or front.
j) You can leave the
Power Head in the Self­Administrator to easily apply to the front of the chest.
Coughing is a normal result and a benefit of
percussion.
Limit percussion to 20 minutes maximum per session
to avoid overheating the system.
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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 Self­Administrator during treatment, pulling the straps toward the chest will correct its position.
Electro Flo® 5000 – User Manual
CAUTION 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.
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Electro Flo® 5000 – User Manual

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.
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.
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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 needed.
CAUTION - DO NOT spray disinfectant on the Control Box and Power Head; this can cause fluid ingress and damage the system.
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 dirt 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.
CAUTION – DO NOT use bleach on fabric.
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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.
CAUTION – If the percussor filter becomes clogged with lint deposits, the unit will shut off permanently.
2. 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.
CAUTION – Do not insert extension tube into the opening as is it might damage the fan.
Disposal
Please dispose of your retired percussor by contacting your local landfill and requesting a designated e-waste drop off location. Alternatively, you may return the retired unit to Med Systems for disposal.
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Electro Flo® 5000 – User Manual

Repairs

NOTE – 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:
Cycle,  Have a running fan,  Show a green light while plugged in and the power
is switch on,
Show a blinking blue light when power is turned
above the Stand By position,
Have percussive action with a blinking blue light
and running fan,
Or, has a cracked or broken part.
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.
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Electro Flo® 5000 – User Manual

Warranty

Electro Flo 5000 & Self-Administrator
MED SYSTEMS warrants these products against defective materials or workmanship for three years from date of purchase, in the United States and Canada. MED SYSTEMS warrants the Electro Flo 5000 System for one year from date of purchase in other countries. 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 use 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 wayFailure to follow the fan vent dust removal procedure
listed on page 19.
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.
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Electro Flo® 5000 – User Manual
Storage & Transport Temperature
Medical Chest Percussor Durable Medical Equipment
Degree of Protection Against Water Ingress

Operating Environment

Operating Temperature 50°F to 95°F (10°C to 35°C)
32°F to 158°F (0°C to 70°C)
Relative Humidity MAX 95%, Non-Condensing

Specifications

Category Specification
Product Type
Model Model 5000
Electrical Classification
Type BF, Patient Contact Allowed
Ordinary (IPX0)
Operating Input Voltage 120 VAC, Single Phase
Supply Current Frequency 50/60 HZ
Nominal Operating Voltage 120 VAC, Single Phase
Duty Cycle 20 minutes on, 20 minutes off
Information/ Regulatory CLASS II Electrical System
Double Insulation
Medical Equipment with respect to Electric Shock, Fire and Mechanical Hazards only, in accordance with UL60601-1/CAN/CSA C22.2 NO. 601.1
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Electro Flo® 5000 – User Manual
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2631 Ariane Drive, San Diego, CA 92117, USA
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ISO 13485 Compliant Company
U.S. Toll Free 800-345-9061
Office 858-483-9671
Fax 858-483-9827
www.medsystems.com
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