Salter 8350-1 User manual

Salter AIRE Elite™
Compressor
Instruction Manual
Part No: 8350-1 / 8352-1 / 8353-1
Thank you for selecting the Salter AIRE Elite Compressor.
Salter Labs is an innovative, industry-leading manufacturer
of respiratory care devices. Please contact your local Salter
Labs dealer for information about additional products.
SAVE THESE INSTRUCTIONS.
READ ALL INSTRUCTIONS BEFORE USE.
Contents
Important Safeguards………………………………….………………1
Introduction…………………………………………………………………2
Product Description…………………….……………………………..3
Operation……………………………………………………………..…….4
Cleaning……………………………………………..………………………..5
Storage……………………………………………………………………….6
Maintenance………………………………………………………………7
Expected Service Life…………………………………………………8
Troubleshooting…………………………………………………………9
Specifications.……………………………….……………………………10
Accessories….……………………………………………………………11
Appendix A………………………………………………………………12
1. Important Safeguards
NOTE, CAUTION, WARNING, AND SYMBOLS:
Important information is highlighted by using the following:
NOTE Indicates information that user should pay special attention
to.
CAUTION Indicates correct operating or maintenance procedures in
order to prevent damage to or destruction of the equipment or other
property.
WARNING Indicates potential danger that requires correct
procedures or practicesin order to prevent personal injury.
Symbols:
O
Off, disconnection from the mains
I
On, connection to the mains
～
Alternating Current (AC)
IP2X
Protected against solid foreign objects having a
diameter of 12.5 mm and greater. No protection against
vertically falling water drops, Keep dry !
Attention
Class II
Refer to instruction manual/ booklet
“BF” symbol, indicate this product is according to the
degree of protecting against electric shock for the type
BF equipment.
Temperature limitation
Disposal of Electrical & Electronic Equipment (WEEE):
This product should be handed over to an applicable
collection point for the recycling of electrical and
electronic equipment. For more detailed information
about the recycling of this product, please contact your
local city office, household waste disposal service or the
retail store where you purchased this product.
CAUTION U.S. Federal Law restricts this device to sale by or on the
order of a physician.
WARNING To reduce the risk of burns, electrocution, fire or
injury to persons:
1. Always unplug this product immediately after using.
2. Do not use while bathing, showering, dish washing, or close to
water sources of any kind.
3. Do not place or store product where it can fall or be pulled
into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug
immediately.
6. This product should never be left unattended when plugged in.
7. Close supervision is necessary when this product is used by,
on or near children or invalids. Choking accident may result
from a child swallowing a small part that has become detached
from the device or its accessories.
8. Use this product only for its intended use as described in this
manual. Use this product only under doctor’s direction. Do not
use attachments not recommended by the manufacturer.
9. Never operate this product if a) it has a damaged cord or plug,
b) it is not working properly, c) it has been dropped or
damaged, d) it has been dropped into water. Return the
product to a specified service center for examination and
repair.
10. Keep the cord away from heated surfaces.
11. Never block the air openings of this product or allow objects to
fall or be inserted into the air vent openings or place it on a
soft surface such as bed or couch, where the air openings may
be blocked.
12. Never use while sleeping or feeling drowsy.
13. Never drop or insert any object into any opening or hose.
14. No modification of this equipment is allowed.
15. Do not modify this equipment without authorization of the
manufacturer.
16. If this equipment is modified, appropriate inspection and
testing must be conducted to ensure continued safe use of the
equipment.
17. Do not use in outdoors or operate where aerosol (spray)
products are being used or where oxygen is being
administered in a closed environment such as an oxygen
reservoir.
18. Do not wrap the power cord around the compressor (main
unit).
19. Disconnect the power plug by pulling the plug, not by pulling
on the compressor (main unit), or the cord.
20. If the power cord or plug becomes frayed or otherwise
damaged, do not use.
21. Do not place heavy objects on the power cord, or bend and
pull the cord harder than necessary. These actions could cause
an electric shock or fire.
22. Potential allergic reactions to accessible materials used in the
Compressor Nebulizer equipment. If any signs of allergic
reaction or hypersensitivity happen, stop the treatment
immediately, and notify the doctor or nurse.
23. Potential contact injuries for patients used in the Compressor
Nebulizer equipment. If any contact injuries happen, stop the
treatment, and notify the doctor or nurse.
WARNING EMC Statement
This equipment has been tested and found to comply with the
limits for medical devices to the EN 60601-1:2007. These limits are
designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment
generates uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to
other devices, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from
that to which the other device(s) are connected.
Consult the manufacturer or field service technician for help.
CAUTION If there is a possibility of electro-magnetic interference
with mobile phones, please increase the distance (3.3m) between
devices or turn off the mobile phone.
2. Introduction
2.1 Intended Use
The Salter AIRE Elite Compressor System is intended to provide a
source of compressed air for aerosol therapy. It is used in
conjunction with a jet (pneumatic) nebulizer to produce medicated
aerosols for inhalation by pediatric and adult patients with
respiratory symptoms.
CAUTION Aerosolize liquid medication except Pentamidine for
inhalation by the patients. Indications for therapy include asthma,
chronic bronchitis, infection of the upper respiratory tract, chronic
obstructive pulmonary disease (COPD) and other respiratory
disorders in accordance with a medical doctor’s prescription. Except
the usage mentioned above, please do not use this product for any
other purpose. This device can be used with adults or pediatric
patients under physician’s prescription.
2.2 Safety Precaution Instruction
When using this electrical product, especially when children are
present, one should always follow basic safety precautions. Do not
install, maintain or operate this equipment without reading,
understanding and following the proper Salter AIRE Elite
Compressor System instruction manual, otherwise injury or
damage may result.
For 120V only-This appliance has a polarized plug (one blade is
wider than the other). To reduce the risk of electric shock, this plug
is intended to fit into a polarized outlet only one way. If the plug
does not fit fully into the outlet, reverse the plug. If it still does
not fit, contact a qualified electrician. Do not modify the plug in any
way.
3. Product Description
1. Power Switch 5. Power Cord
2. Filter Cap (disposable filter inside) 6. Nebulizer Cup Holder
3. Air-Outlet Connector 7. Cooling Air Openings
4. Integrated Carrying Handle
4. Operation
NOTE Before initial operation, the nebulizer cup assembly should
be cleaned following instructions described in the “Cleaning”
section.
WARNING Before connecting the power cord, make sure the I/O
(ON/OFF) switch is in the O (OFF) position.
The plug is also served to disconnect the device. Do not
position the equipment so that it is difficult to operate
the disconnecting device.
4.1 Daily Use Operation
CAUTION The Salter AIRE Elite Compressor System is designed for
intermittent use only. Do not operate it continuously for more than
30 minutes for a single use without turning it off and following a
cooling period for least 30 minutes.
1. Before each use inspect the Salter AIRE Elite Compressor
and nebulizer cup assembly for damage or wear, replace as
needed.
2. Place the Salter AIRE Elite Compressor on a table or other
flat stable surface. Be sure you can easily reach the controls
when seated. Do not use this device on the floor.
3. With the power switch in the O (OFF) position, plug the power
cord into an appropriate electrical wall outlet.
4. Connect one end of the tubing to the compressor air-outlet
connector.
5. Assemble the nebulizer cup and add indicated medication to
the nebulizer’s cup before use.
6. Attach the other end of the tubing into the air-inlet connector
founded at the bottom of the nebulizer cup.
7. Turn on the Salter AIRE Elite Compressor by pressing the
power switch to the I (ON) position and begin treatment.
8. If treatment needs to be interrupted, simply press power
switch to O (OFF) position.
9. When the treatment is complete, turn off the compressor by
pressing the power switch to O (OFF) position and unplug the
unit from the electrical outlet.
Equipment is not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or
nitrous oxide. This device has no AP or APG protection.
CAUTION During the treatment, the patient should not touch the
outer case due to expected rise in unit temperature.
4.2 Safety Overload
NOTE Do not exceed 30 minutes of continuous operation.
1. The motor of this device has a built-in thermal overload
protector. Should the motor overheat, the protector will
automatically shut off the motor. Should this occur, turn the
I/O (ON/OFF) switch to the O (OFF) position and allow the
motor to cool down for approximately 30 minutes before turn
it on again.
2. If the overload protector shuts off the motor frequently, you
may have an unstable voltage situation.
3. If the unit shuts down and cannot restart, it may need to be
replaced. Call your provider immediately.
5. Cleaning
5.1 Compressor Outer Case Cleaning
WARNING Electric shock hazard. Do not remove outer case of
this unit. All disassembly and maintenance of this unit must be
done by a qualified service technician. Refer servicing to
qualified service personnel.
WARNING This unit does not require oil. Do not attempt to
lubricate any internal parts.
WARNING Unplug unit before cleaning. Do not submerge in
water for cleaning.
1. Wipe the main unit with a damp cloth every few days to keep
it dust-free.
2. Do not use any powdered type cleaners or soap. Do not
submerge the unit into water.
5.2. Nebulizer Cup Cleaning
Clean the nebulizer after each use. Refer to the cleaning
instructions supplied with your nebulizer
800987 Rev D (Side 1) Printed on 15 April 2015

WARNING To prevent possible risk of infection from
contaminated medication, cleaning of the nebulizer is
recommended after each treatment.
NOTE The nebulizer kit is for single patient use only.
NOTE Please follow national requirements to dispose the unit
properly.
6. Storage
Keep the unit and accessories dry. Avoid direct sunshine. See
specifications in Section 10 for appropriate environmental storage
conditions.
7. Maintenance
7.1 General Information
1. This unit is oil-less. Do Not Lubricate.
2. Risk of electric shock. Do not disassemble the main unit.
7.2 Filter Change
NOTE Inspect the filter once every month and
replace as necessary or when filter turns gray.
Please follow the below instructions as right
figures.
1. Open the filter cap.
2. Inspect the filter and if dirty, remove filter
with a small, pointed object. Discard the
filter.
3. Replace with a clean filter. Additional filters
should be purchased from your provider.
4. Put the filter cap back.
CAUTION Do not use cotton or any other material as a filter. Do not
wash or reuse the filter. Do not operate the unit without a filter.
7.3 Service
Except for the above instructed user maintenance, all device
servicing must be performed by a Salter Labs®authorized service
representative. There are no serviceable parts inside the unit.
Contact your Salter Labs dealer or authorized service center if your
unit needs repair.
WARNING Do not tamper with or attempt to repair the device.
Refer servicing to qualified service personnel.
8. Expected Service Life
The products are intended to offer safe and reliable operation when
used or installed according to the instructions provided by Salter
Labs. Salter Labs recommends that the system be inspected and
serviced by authorized technicians if there are any signs of wear or
concerns with device function and indication on products.
Otherwise, service and inspection of the devices generally should
not be required.
9. Troubleshooting
If your Salter AIRE Elite Compressor fails to function, consult the
Troubleshooting guide below. If the problem persists, consult your
equipment provider.
Problem Cause and Solution
Device doesn’t
operate.
‧
Check if plug is properly fit into an appropriate
electrical outlet.
‧When device has been run continuously for over
30 minutes right before using, an auto shut down
may activate by built-in thermal protector, cool
down device for 30 minutes before next usage.
Weak
Nebulization
‧
Check for proper electrical voltage.
‧
Check tubing for blockage or air leakage at
connection to Salter AIRE Elite Compressor or
nebulizer cup, replace as needed.
‧Check the nebulizer cup if it is properly assembled
and not damaged. If there is any damage, replace
as needed.
‧
Check if filter is too dirty, replace as needed.
10. Specifications
(All specifications are subject to change without notice.)
Electrical Rating
(Note: Refer to the rating
label on the product)
120VAC,60Hz,1.2A
( For 120V System)
230VAC,50Hz,0.6A
( For 230V System)
Maximum Compressor
Pressure
≧30 psi
Nebulizer Flow Rate
≧5.5 lpm
≧5.0 lpm
Classification
Class II.
BF equipment.
IP2X
No AP/APG protection.
Applied part
Mouthpiece or Nasal mask
Dimensions (W x D x H)
14.6 × 20.3 × 9.5 cm /
5.7” × 7.9” × 3.7”
Weight (approx.)
1.8 kg / 4.0 lb
Fuse (non-user serviceable)
F5AL 250V
T1.6AL 250V
Warranty
5 Years
Environment
Temperature
Operation: 10℃to 40℃/ 50℉to 104℉
Storage: -15℃to 50℃/ 5℉to 122℉
Transport: -15℃to 70℃/ 5℉to 158℉
Humidity
Operation: 10% to 90%RH non-condensing
Storage: 10% to 90%RH non-condensing
Transport: 10% to 90% RH non-condensing
Atmospheric
pressure
Operation: 700-1060 hPa
11. Accessories
Mo del Description
8501-1-2 Salter AIRE Elite Replacement filters
8258-0-1 Compressor Carrying bag
8660 NebuTech® Nebulizer – Reusable
8960 NebuTech Nebulizer – Disposable
8967 NebuTech Nebulizer with Pediatric Mask
8984 NebuTech Nebulizer with Adult Mask
8900 Nebulizer with Tee Adapter
8906 Nebulizer with Pediatric Mask
8924 Nebulizer with Adult Mask
12. Appendix A: EMC Information
Guidance and Manuf acturer’s Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment
specified below. The user of this device should make sure it is used
in such an environment.
Emissions
Test Compliance Electromagnetic Environment-Guidance
RF emissions
CISPR 11
Group1
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic equipment
RF emissions
CISPR 11
Class B
The device is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network.
Harmonic
emissions
IEC61000-3-2
Class A
Voltage
fluctuations /
Flicker
emissions
IEC61000-3-3
Complies
Guidance and Manuf acturer’s Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment
specified below. The user of this device should make sure it is used
in such an environment.
Immunity Test IEC60601
test level Compliance Electromagnetic Environment-Gui da n ce
Electrostatic
Discharge (ESD)
IEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/ burst
IEC61000-4-4
±2kV for power
supply line
±1kV for
input/out line
±2kV for
power supply
line
±1kV for
input/out line
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s)
to
line(s)
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips ,
short
interruptions
and voltage
variations on
power supply
input lines
IEC61000-4-11
<5 % UT(>95
% dip in U
T
)for
0,5 cycle
40 % UT
(60 %
dip in UT)
for 5 c y c le s
70 % UT
(30 %
dip in UT)
for 25 cycles
<5 % UT
(>95
% dip in UT) for
5 sec
<5 % UT(>95
% dip in U
T
)
for 0,5 cycle
40 % UT
(60
% dip in UT
)
for 5 cycles
70 % UT
(30
% dip in UT
)
for 25 cycles
<5 % UT
(>95
% dip in UT)
for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
this device requires
continued operation
during power mains
interruptions, it is
recommended that the
device be powered from
an uninterruptible power
supply or a battery.
Power
frequency
(50/60Hz)
magnetic field
IEC61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: UTis the AC mains voltage prior to the application of the test level
Recommended separation distances between portable and
mobile RF communications equipment and this device:
This device is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or
the user of this device can help prevent electromagnetic
interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and this
device as recommended below, according to the maximum output
power of the communications equipment
Rated
maximum
output
power
Separation distance according to frequency of transmitter (
m)
150 kHz to 80 MHz
Pd 2.1
=
80 MHz to 800 MHz
Pd 2.1=
800 MHz to 2,5 GHz
Pd 3.2=
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance
d
in meters (m) can be estimated using
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 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects,
and people.
Guidance and Manuf acturer’s Declaration - E lec tro ma gnetic I mmuni ty:
This device is intended for use in the electromagnetic environment
specified below. The user of this device should make sure it is used
in such an environment.
Immunity
Test
IEC60601 test
le ve l
Compliance Electromagnetic
Environment-Gui da n ce
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3Vrms150 kHz
to 80 MHz
o u ts i de I S M
ba ndsa
3 V/m 80
MHz to 2.5 GHz
3 Vrms
3 V/m
Po rta b le a nd m ob ile R F
communications equipment
should be used no closer to any
part of this device, including
cables, than there commended
separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Pd 2.1=
150kHz to 80MHz
Pd 2.1=
150kHz to 80MHz
Pd 3.2=
80 MHz to 2.5G MHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).b
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey c,
should be less than the compliance
level in each frequency ranged.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
a/
The ISM (industrial, scientific and medical) bands between 150 kHz and
80 MHz are 6,765 MHz to 6,795 MHz;13,553 MHz to 13,567 MHz; 26,957
MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b/ The compliance levels in the ISM frequency bands between 150 kHz and
80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to
decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For
this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency
ranges.
c/ 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, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the device is used exceeds
the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
d/ Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.
100 W. Sycamore Rd.
Arvin, CA 93203 USA
Tel: [phone]
800-421-0024 (in CA)
800-235-4203 (outside CA)
Fax: [phone]
800-628-4690 (US & Canada)
Internet: www.salterlabs.com
Authorized Representative in the E.U.:
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert, Germany
NOTE Consult distributor(s) or EU representative(s) for
additional technical documents.
0086
800987 Rev D (Side 2) 666001-6720 V1.0