eFlow IFU

Transcription

eFlow IFU

Patent No.s: US 5,152,456; US 5,261,601; US 5,518,179
Additional Patents Pending

Electronic Nebulizer
Featuring
Instructions For Use
®
Specialists in effective inhalation
2
QUESTIONS CALL 888-eFLOW-INFO (335-6946)
TABLE OF CONTENTS
A
B
C
D
E
F
G
H
I
J
K
L
M
N
INTRODUCTION ................................................................................................................................. 4
SAFETY PRECAUTIONS AND IMPORTANT SAFEGUARDS ............................................................. 4-7
GETTING STARTED ......................................................................................................................... 8-9
USING “AA” BATTERIES .................................................................................................................. 10
USING OPTIONAL AC POWER SUPPLY .......................................................................................... 11
eFlow NEBULIZER HANDSET ASSEMBLY .................................................................................. 12-15
TAKING A TREATMENT ............................................................................................................... 16-19
eFlow NEBULIZER HANDSET CLEANING ................................................................................... 20-22
eFlow NEBULIZER HANDSET DISINFECTION .................................................................................. 23
CONTROL UNIT MAINTENANCE ...................................................................................................... 23
FUNCTIONALITY TEST ..................................................................................................................... 24
FREQUENTLY ASKED QUESTIONS AND TROUBLESHOOTING .................................................. 25-26
eFlow ACCESSORIES ....................................................................................................................... 26
SPECIFICATIONS ............................................................................................................................. 27
QUESTIONS CALL 888-eFLOW-INFO (335-6946) 3
A
INTRODUCTION
These Instructions For Use contain information and safety precautions for the eFlow® Electronic Nebulizer
(eFlow®). Save these Instructions For Use for future reference.
Before using your eFlow®, you should read and understand the entire Instructions For Use for the eFlow® .
Take special note of all safety precautions marked DANGER and WARNING.
The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
B
SAFETY PRECAUTIONS AND IMPORTANT SAFEGUARDS
READ ALL WARNINGS BEFORE USING
CAUTION U.S. Federal Law restricts this device to sale by or on the order of a physician.
DANGER
To reduce the risk of serious or fatal injury from electrocution:
1. Always unplug this product immediately after using.
2. DO NOT place or store the eFlow where it can be in water or fall into a bathtub, sink, or other liquid. Do
not place or drop into water or other liquid. Do not use while bathing.
3. DO NOT reach for the eFlow if it has fallen into water or other liquid. Unplug immediately. Retrieve
eFlow ONLY after it has been unplugged.
4
B
To reduce the risk of serious or fatal injury from electrocution, fire, burns and to reduce the risk of damage
and malfunction of the unit:
4. NEVER operate this product if:
a) it has damaged cords or plugs,
b) it is not working properly,
c) it has been dropped or damaged, or
d) it has been exposed to any liquids inside the case.
5. ALWAYS return the product to an Authorized eFlow Support Center (see back cover for details) for
replacement if the product has been damaged or is not operating properly. If you suspect that the
product has been damaged or is not working correctly, run the Functionality Test described in Section K.
WARNING
Use the eFlow ONLY when prescribed by a physician and ONLY with medications prescribed by a physician for
the eFlow. DO NOT use any medications that are not prescribed specifically for the eFlow. Use of unapproved
medications or medications prescribed for a different aerosol delivery device (e.g. nebulizer) may lead to
serious or fatal injury.
1. Use this product only for its intended use as described in these Instructions For Use. Improper use can
result in serious or fatal illness or injury, improper treatment or property damage.
2. DO NOT drop or insert any object into any opening on the eFlow.
3. Keep all electrical cords away from heated surfaces.
B
WARNING (Continued From Page 5)
4. DO NOT overload wall outlets or use extension cords.
5. DO NOT operate where oxygen is being administered in a closed environment such as an oxygen tent.
6. UNPLUG the Control Unit before cleaning or filling. Do not overfill.
7. DO NOT disassemble the Control Unit. Contact your Authorized eFlow Support Center (see back cover
for details) for all service needs.
8. Use ONLY adapters and accessories that are authorized for the eFlow. Use of unapproved adapters and
accessories can lead to improper treatment, injury, or damage to the Control Unit.
9. DO NOT spray liquids onto the housing of the Control Unit. Liquid may cause damage to the electrical
parts and could lead to a malfunction. In the event that liquids enter the Control Unit, return the product
to an Authorized eFlow Support Center for examination and repair.
10. eFlow is for single patient use only. DO NOT share your eFlow with other people.
11. To reduce the risk of an infection, illness, or injury from contamination, clean and dry all parts of the
eFlow after each treatment. Follow the instructions in Section H to clean the eFlow properly.
6
B
12. Cleaning the eFlow Nebulizer Handset properly will prevent the Aerosol Head from clogging. If the
Aerosol Head becomes clogged, the aerosol mist will be reduced or stopped, which may make the
treatment ineffective. If clogging occurs use the instructions in Section H to clean the Aerosol Head.
13. Cleaning the eFlow Nebulizer Handset after each treatment is not enough. To prevent serious or fatal
illness caused by contamination of the eFlow, YOU MUST ALSO DISINFECT THE eFlow NEBULIZER
HANDSET REGULARLY. See Section I for disinfection instructions.
14. This product contains small parts that may present a choking hazard to small children. The eFlow
Nebulizer Connection Cord also presents a strangulation hazard.
15. DO NOT LEAVE CHILDREN UNATTENDED DURING TREATMENT. ALWAYS USE CLOSE ADULT
SUPERVISION WHEN ADMINISTERING A TREATMENT TO A CHILD.
19. Close supervision is necessary when this product is used by or near children or the physically or
mentally impaired.
20. Before use, check your eFlow for proper assembly. All parts must be connected and firmly in place. Use
of an improperly assembled eFlow could diminish or eliminate the effectiveness of the treatment.
21. DO NOT use your eFlow while driving or in any situation which takes away your full attention.
C
GETTING STARTED
Check your eFlow package to ensure you have the following items:
1. Carrying Case
2. Control Unit
1
3. Nebulizer Connection Cord
4. “AA” Batteries
5. AC Power Supply

6a. Medication Cap with 6b. Cap Seal
7. Aerosol Head
8a. Medication Reservoir with 8b. Aerosol Chamber
9. Inspiratory Valve
10a. Mouthpiece with 10b. Expiratory Valve
If you do not have all the items, please call the number listed below.
Figure 1
8
GETTING STARTED
C
6a
2
7
6b
5
9
8a
4
8b
10b
10a
3
Figure 2
D
USING “AA” BATTERIES
1. The eFlow is designed to be used with “AA” batteries or with the
optional AC Power Supply. Four (4) new “AA” batteries will
provide approximately 1.5 hours of continuous treatment. You
may also use “AA” rechargeable batteries. Please see "Specifications" on page 27 for both types of batteries. NOTE: It is always
recommended to have an extra battery set with you at all times.
2. Open the battery door on the Control Unit by placing your thumb
on the tab of the battery door and firmly push the tab to open
the door (Figure 5).
Figure 5
3. Place the Control Unit on a flat, stable surface to load the batteries.
4. Each battery chamber has a small figure that shows the proper
position of each battery (Figure 6). Using the battery “tips” as
guides and starting left-to-right, insert the batteries: Tip Out, Tip
In, Tip Out, Tip In.
5. To close the battery door, push it closed until you hear it “click”
into place. NOTE: Rechargeable and Disposable Batteries vary
considerably in terms of storage life and output. Operating life of
1.5 hours of use is based on disposable batteries that meet the
specifications listed on page 27.
BATTERY LOW: The LED on the Control Unit will “FLASH” red at one
second intervals to indicate that battery power is low and it's time to
change the batteries. The eFlow will switch itself off shortly thereafter.
10
Figure 6
USING OPTIONAL AC POWER SUPPLY
E
1. eFlow can also be used with the optional AC Power Supply. The
AC Power Supply is especially useful as a back-up power supply
when the batteries are depleted. Insert the Plug Converter into
the AC Power Supply as shown (Figure 7).
Figure 7
2. The AC Power Supply (Figure 7) can be used with 100-240V and
will automatically adjust to the incoming voltage. It can be used
worldwide, but does require “Plug Converters” for use outside
the USA. Additional Plug Converters for the eFlow are available
as optional accessories. Call the number below for details. Make
sure you use the right Plug Converter for the AC outlet.
3. To connect the AC Power Supply to the Control Unit, place the
Control Unit on a flat, stable surface.
4. The plug inlet is located on the under side of the battery door.
Push the round end of the AC Power Supply cord in to the plug
port (Figure 8).
5. Plug the AC Power Supply into the wall outlet.
Figure 8
F
eFlow NEBULIZER HANDSET ASSEMBLY
1. IMPORTANT: The eFlow Nebulizer Handset is not sterile. Clean
the eFlow Nebulizer Handset before using for the first time and
after each treatment (see Section H for cleaning instructions).
Inspect all parts to ensure they are clean and are not visibly
damaged. Do not use dirty or damaged parts.
2. The Medication Reservoir and the Aerosol Chamber are attached
using a “hinge”. First, gently pull up on the tab of the Medication
Reservoir. This will release the Aerosol Chamber so that you
may open it (Figures 9 and 10).
Tab
Figure 9
12
Figure 10
F
3. Being careful to touch ONLY the plastic outer ring of the Aerosol
Head, press the two flexible plastic tabs on the side of the
Aerosol Head while firmly inserting it into the Medication
Reservoir. You should feel the plastic tabs “grab” as you insert it
(Figures 11, 11a and 11b). NOTE: It is important that you do not
touch the metal part of the Aerosol Head (Figure 12).
Figure 11
Figure 11a
Figure 11b
Figure 12
F
4. Attach the Inspiratory Valve by pressing into the groove on
the Aerosol Chamber. Note the correct orientation for the valve.
Using a single finger around the edge of the valve, press the
valve in place (Figure 13).
Figure 13
14
F
5. Close the eFlow Nebulizer Handset by pulling the Aerosol
Chamber together with the Medication Reservoir until you hear a
“snap” (Figure 14). If you do not hear a slight snap, open the
eFlow Nebulizer Handset and ensure that the Inspiratory Valve is
seated properly.
Figure 14
6. The Medication Cap consists of 2 parts: The Medication Cap and
the Cap Seal. To remove the Cap Seal from the Medication Cap,
hold the Medication Cap using both hands with the ridges facing
upward. Using your thumb, press the center of the Medication
Cap down (Figure 15). To re-insert, line up the four snap
locks with the 4 prongs and press using your fingers from
the underside of the cap. You should hear a snap. Set the
Medication Cap aside. NOTE: The rubber valve on the underside
of the Cap Seal should be facing up in a “bowl” shape. This
ensures a good seal to the Medication Reservoir.
Figure 15
G
TAKING A TREATMENT
IMPORTANT: Your medication should be at room temperature before
use to ensure that the eFlow operates properly.
1. Place the Control Unit on a clean, flat, stable surface. Slide the
eFlow Nebulizer Handset into the Control Unit “cradle” as far as
it will go (Figure 16).
2. Attach the Mouthpiece to the front of the Aerosol Chamber. The
blue expiratory valve should be facing upwards (Figure 16).
3. Pour only the medication prescribed by your physician specifically
for the eFlow into the Medication Reservoir (Figure 17). DO NOT
USE MEDICATIONS PRESCRIBED FOR OTHER NEBULIZERS IN
THE EFLOW.
Figure 17
4. Close the Medication Reservoir by aligning the tabs on the inside of
the Medication Cap with the tab slots in the Medication Reservoir.
Turn the cap clockwise as far as it will go (Figure 18).
Figure 16
16
Figure 18
TAKING A TREATMENT
Figure 20a
G
5. There are 2 ways that you can take your treatments with eFlow:
a. eFlow Attached To Control Unit: After filling the Medication
Reservoir, leave the eFlow in the cradle. Pick up the Control
Unit and hold the Mouthpiece to your mouth like a “sandwich” (Figure 19).
b. eFlow Attached To Nebulizer Connection Cord: Remove the
eFlow from the cradle before turning on the eFlow. Snap the
eFlow Nebulizer Connection Cord onto the rear underside of
the eFlow (Figures 20 and 20a). Slide the other end of the
Nebulizer Connection Cord into the cradle to make contact
with the metal power plates (Figure 21).
Figure 20
Figure 21
Figure 19
G
TAKING A TREATMENT
6. To begin your treatment, sit in a relaxed, upright position. Press
and hold the On/Off button for one second (Figure 22). You will
hear one “beep” and the status light will illuminate green. The
eFlow is now ON.
7. After a few seconds, aerosol mist will begin to flow into the
Aerosol Chamber.
8. Place the Mouthpiece on top of your bottom lip and tongue, and
close your lips around it (Figure 23). Hold the eFlow level. If held
at an angle over 45 degrees, nebulization may stop and the unit
will shut off after 30 seconds. If this occurs, hold the eFlow level
and press the start button to complete the treatment.
9. Take slow, deep breaths in and out through the Mouthpiece.
Each breath should be a little deeper than normal, quiet
breathing, but not to your full capacity. Do Not breathe through
your nose. Continue to inhale and exhale comfortably until the
treatment is finished.
Figure 22
18
TAKING A TREATMENT
G
10. When all of the medication has been delivered:
a) You will hear the “Treatment Complete Alarm” (2 beeps and 2
green lights).
b) The eFlow will automatically shut off.
11. If for any reason you must stop the treatment before completion, press
and hold the On/Off Button for one second. A 1 beep alarm will
sound with 1 red light. To re-start the treatment,
press and hold the On/Off Button for one second and then resume
the treatment.
12. After you have completed your treatment, disassemble the eFlow for
cleaning. See Section H for full cleaning instructions.
Figure 23
H
eFlow NEBULIZER HANDSET CLEANING
1. Clean the eFlow Nebulizer Handset after every treatment. DO
NOT wash the Control Unit, Nebulizer Connection Cord or Power
Adapters. Use liquid soap designed for washing dishes. Do not
use “white” liquid dish soaps (e.g. Ivory) or antibacterial liquid
soaps as these may contain additives harmful to the eFlow.
2. Remove the eFlow Nebulizer Handset from the cradle or
disconnect the eFlow Nebulizer Handset from the Nebulizer
Connection Cord.
3. Disassemble the eFlow parts:
Figure 24
Figure 25
a. Remove the Medication Cap from the Medication Reservoir
(Figure 24).
Tab
b. To remove the Cap Seal from the Medication Cap, hold the
Medication Cap using both hands with the ridges facing
upward. Using your thumb, press the center of the Cap Seal
down (Figure 25).
c. Remove the Mouthpiece from the Aerosol Chamber (Figure 26).
d. Gently pull up on the tab of the Medication Reservoir. This
will release the Aerosol Chamber so that you may open it
(Figure 27).
Figure 26
20
Figure 27
H
e) Being careful to only touch the outer ring of the Aerosol Head,
press the two flexible plastic tabs on the side of the Aerosol
Head and pull out gently”. DO NOT TOUCH THE METAL PART
OF THE AEROSOL HEAD (Figure 28).
f) Remove the Inspiratory Valve from the Aerosol Chamber.
(Figure 29).
Figure 28
g) There is no need to remove the Medication Reservoir from the
Aerosol Chamber for cleaning or disinfecting. This should
only be done if you need to replace one of the parts.
Figure 29
H
4. Add a few drops of the soap to a clean bowl or basin and add
warm tap water.
5. To wash the eFlow Nebulizer Handset, start by thoroughly
rinsing each of the disassembled parts under warm running tap
water for approximately 10 seconds. It is important to rinse both
sides of the Aerosol Head for at least 10 full seconds on each
side (Figure 30). NEVER USE A BRUSH OR ANY OTHER
OBJECT TO CLEAN THE AEROSOL HEAD (Figure 31). Thorough
rinsing of both sides of the Aerosol Head helps to prevent
clogging and ensure proper operation.
6. Gently wash each part in the soapy solution and rinse
thoroughly.
Figure 30
7. After cleaning, disinfect the eFlow parts (see Section I for
disinfection instructions).
8. Air dry the eFlow parts on a clean, lint-free towel.
9. After the eFlow parts are completely dry, reassemble the eFlow.
Figure 31
22
I
eFlow NEBULIZER HANDSET DISINFECTION
1. Clean the eFlow Nebulizer Handset as described in Section H.
2. Once a week (or as directed by your health care professional) disinfect the eFlow Nebulizer Handset
with a commercially available medical device disinfectant such as Control III (Control III Home Care
Kit or CIDEX Activated Dialdehyde Solution). Follow the disinfectant manufacturer’s directions for use.
3. After disinfecting, rinse all parts of the eFlow Nebulizer Handset thoroughly with warm tap water and
allow to air dry on a clean paper or lint-free towel.
4. To clean the Control Unit, wipe down the exterior housing with a damp cloth. DO NOT allow liquids to get
inside the battery compartment.
CONTROL UNIT MAINTENANCE
J
1. Never operate the eFlow Control Unit if it is improperly or incompletely assembled, or damaged.
DO NOT open or disassemble the Control Unit at any time.
2. There are no user serviceable parts inside the eFlow Control Unit. Repairs, service and maintenance
should only be performed by an Authorized eFlow Support Center.
3. If your eFlow is damaged or does not operate properly, contact your Authorized eFlow Support Center.
K
FUNCTIONALITY TEST
A functionality test should be performed on the eFlow prior to initial use to ensure that the unit was not
damaged during shipping. This test takes only a few minutes to complete and will verify that your eFlow is
working properly. This function test should also be performed any time that you suspect the eFlow has been
damaged or is not functioning correctly.
1. Assemble the eFlow as described in Section F, but do not attach the Mouthpiece (or exhalation filter,
if applicable).
2. Fill the Medication Reservoir with 1 ml of sterile water or sodium chloride 0.9%. Close the Medication
Reservoir with the Medication Cap (see page 16).
3. Press and hold the On/Off button for one second. You will hear one (1) beep and the status light will
illuminate green. The eFlow is now ON.
4. Use a stopwatch or timer to measure how long it takes to nebulize the liquid and automatically shut off.
5. After the eFlow has automatically shut off, remove the cap and check the amount of liquid in the
Medication Reservoir. Only a few drops of medication should remain in the Medication Reservoir. If
more than a few drops remains, clean the stainless steel Aerosol Head and repeat the test. If, after
proper cleaning, there are still more than a few drops remaining in the Medication Reservoir, contact an
Authorized eFlow Support Center.
6. If the time to nebulize 1 ml of liquid is less than three (3) minutes, the eFlow is functioning correctly. If
it takes more than three minutes to nebulize 1 ml of liquid, contact an Authorized eFlow Support Center.
24
FREQUENTLY ASKED QUESTIONS AND TROUBLESHOOTING
L
QUESTION 1: How much medication should be left in the Medication Reservoir at the end of a treatment?
Answer: Only a few drops of medication should remain at the end of a treatment. If more than a few
drops remains, clean the stainless steel Aerosol Head. If after proper cleaning, there is still more than a
few drops remaining in the Medication Reservoir, contact your Authorized eFlow Support Center.
QUESTION 2: How long should each treatment take?
Answer: With normal operation and proper cleaning the eFlow should deliver a 1 ml treatment within
3 minutes. If more than 3 minutes are required to complete your treatment with 1 ml, contact your
Authorized eFlow Support Center.
QUESTION 3: When I turn on my eFlow, nothing happens. There does not seem to be any power.
What is wrong?
Answer: If you are using batteries, use the figures in each battery compartment to verify that the
batteries are inserted correctly. If the batteries are positioned properly, check to see if the light is
blinking on the Control Unit signaling low battery power. If it is, replace the batteries or use the
AC Power Supply.
Answer: If you are using the AC Power Supply, check the adapter connection to be sure it is firmly
connected to the adapter port located underneath the battery compartment. Be sure that the adapter is
plugged into a working wall outlet.
QUESTION 4: How long will a new set of batteries last?
Answer: A new set of batteries will provide approximately 1.5 hours of continuous treatment.
L
FREQUENTLY ASKED QUESTIONS AND TROUBLESHOOTING
QUESTION 5: What if no mist is coming out of the eFlow?
Answer: First check to be sure that the eFlow has been assembled properly. Next check that there is
medication in the Medication Reservoir. If the eFlow is assembled properly and there is medication in
the cup, clean the stainless steel Aerosol Head as described in Section H. If after cleaning the Aerosol
Head the eFlow still does not function properly, call your Authorized eFlow Support Center.
QUESTION 6: What if liquid is leaking from the eFlow during the treatment?
Answer: Be sure that the Inspiratory Valve is properly attached to the Aerosol Chamber to prevent leaks.
Answer: Be sure that the Aerosol Chamber and Medication Reservoir are properly aligned when closing.
If they are properly aligned you will hear a “click” when you connect the pieces together at the hinge.
You will also hear a “click” when the white tab is firmly connected to the Aerosol Chamber.
M
eFlow ACCESSORIES
DESCRIPTION
PART #
12V DC Car Adapter ............................................. For part numbers, please call 1-888-eFlow Info (335-6946)
“AA” Rechargeable Battery Charger ...................................................................................................................
eFlow Mask Set, Size 2 ......................................................................................................................................
eFlow Mask Set, Size 3 ......................................................................................................................................
Mouthpiece ........................................................................................................................................................
International Plug Converter Set ........................................................................................................................
Filter/Valve Set ...................................................................................................................................................
Filter Pads, Pack of 30 .......................................................................................................................................
26
SPECIFICATIONS
N
Weight: Control Unit and eFlow .................................................................................................................. 6 oz
Weight: Control Unit, eFlow, and Batteries .............................................................................................. 9.5 oz
Dimensions .......................................................................................................................... 1.93" X 2.5" X 5.5"
Electrical Requirements .......................................................................................... 110 V - 240 V, 50 Hz/60 Hz
Power Wattage ..................................................................................................... 2.0 Watts under normal load
Aerosol Head Replacement .......................................................................................................... Every 90 days
Aerosol Output Rate .......................................................................................................................... >.4ml/min.
Mass Median Aerodynamic Diameter (MMAD) ............................................................................ 4.26 microns
Minimum Fill ............................................................................................................................................. .5 ml
Maximum Volume Fill ................................................................................................................................. 4 ml
AMBIENT OPERATION:
Temperature Range ..................................................................................................................... 15° C to 35° C
Humidity ......................................................................................................................................... 30% to 95%
RECHARGEABLE BATTERIES
Rechargeable Batteries ..................................................................................................... 1.2V-1.5V, 1500mAh
Rechargeable Battery Operation ....................................................... About 1.5 hours of continuous treatment
Rechargeable Battery Charge Time ...................................................................................................... 15 hours
DISPOSABLE BATTERIES
Panasonic Power Max 3, 1.5V or equivalent; Panasonic Power Digital, 1.5V or equivalent.

Electronic Nebulizer
Manufactured in Germany For:
PARI Innovative Manufacturers, Inc.
2943 Oaklake Blvd.
Midlothian, Virginia USA
1.800.FAST.NEB(327.8632)
Authorized eFlow Support Center: 888-eFLOW-INFO (335-6946)
US 5,152,456
US 5,261,601
US 5,518,179
Additional Patents Pending
Patent No.s:
© 2004 Copyright PARI Aerosol Research Institute
eFlow® is a registered trademark of PARI GmbH. All rights reserved.
Touchspray Technology is a "registered" trademark
Touchspray® is a trademark of The Technology Partnership. All rights reserved.
®
078D1004 Rev. 0 7-15-2004
Specialists in effective inhalation

eFlow IFU

Transcription

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