Salter AIRE Elite 8353-1, AIRE Elite 8352-1, AIRE Elite 8350-1, 8350-1, AIRE Elite Instruction Manual

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Salter AIRE Elite
Compressor
Instruction Manual
Part No: 8350-1 / 8352-1 / 8353-1
Thank you for selecting the Salter AIRE Elite C ompressor. Salter Labs is an innovative, industry-leading manufacturer of respiratory care devices. Please contact your local Salter Labs dealer for information about additional produc ts.
SAVE THESE INSTRUCTIONS.
READ ALL INSTRUCTIONS BEFORE USE.
Contents
Important S afeguards………………………………….………………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 b y using the following:
NOTE Indicates information that user should pay special attention
to.
CAUTION Indicates correct operating or maint enance 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 p ersonal injury.
Symbols:
O
Off, disconnection from the mains
I
On, connection to the mains
Alternating Current (AC)
IP2X
Protected against solid f oreign objects having a diameter of 12.5 mm and greater. No protecti on against vertically falling water drops, Keep dr y !
Attention Class II
Refer to instruction manual/ booklet
“BF” symbol, indicate this product is accord ing to the degree of protecting against electric sho ck for the type BF equipment.
Temperature limitation
Disposal of Electrical & Electronic Equip ment (WEEE):
This product should be handed over to an appli cable collection point for the recycling of electr ical and electronic equipment. For more deta iled information about the recycling of this product, please contact your
local city office, household waste dispo sal service or the retail store where you purchased this p roduct.
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 immediate ly after using.
2. Do not use while bathing, showering, di sh washing, or close to
water sources of any kind.
3. Do not place or store product where it can fall o r 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 unatten ded 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 b ecome 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 docto r’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 prope rly, c) it has been dropped or damaged, d) it has been dropped into water. Re turn 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 ope nings 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 authoriza tion 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, no t by pulling
on the compressor (main unit), or the cord.
20. If the power cord or plug becomes frayed or otherwi se
damaged, do not use.
21. Do not place heavy objects on the power cord, or bend and
pull the cord harder than necessary. These a ctions could cause an electric shock or fire.
22. Potential allergic reactions to accessible materials used in the
Compressor Nebulizer equipment. If a ny signs of allergic reaction or hypersensitivity happe n, 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 injur ies happen, stop the treatment, and notify the doctor or nurse .
WARNING EMC Statement
This equipment has been tested and foun d to comply with the limits for medical devices to the EN 60601-1: 2007. These limits are designed to provide reaso nable 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 i nstructions, may cause harmful interference to other device s in the vicinity. However, there is no guarantee that interferen ce 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 co rrect 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 serv ice technician for help.
CAUTION If there is a possibility of electro-magneti c interference
with mobile phones, please increase the distance (3.3 m) 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) ne bulizer to produce medicated aerosols for inhalation by pediatric an d 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 respir atory tract, chronic obstructive pulmonary disease (COPD) and other respiratory disorders in accordance with a medical doctor’s pres cription. Except the usage mentioned above, please do not use this product f or any other purpose. This device can be used with adults or pediatr ic patients under physician’s prescription.
2.2 Safety Precaution Instruction
When using this electrical product, espec ially when children are present, one should always follow bas ic safety precautions. Do not install, maintain or operate this equipme nt 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 polarize d 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 on ly one way. If the plug does not fit fully into the outlet, reverse the plug. If it still does not fit, contact a qualified electricia n. 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 ne bulizer 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 difficu lt to operate the disconnecting device.
4.1 Daily Use Operation
CAUTION The Salter AI RE Elite Compressor Syst em 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 S alter 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 r each the controls when seated. Do not use this device on the flo or.
3. With the power switch in the O (OFF) positio n, plug the power
cord into an appropriate electrical wa ll outlet.
4. Connect one end of the tubing to the compresso r air-outlet
connector.
5. Assemble the nebulizer cup and add indi cated 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 beg in treatment.
8. If treatment needs to be interrupted, si mply 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) positio n 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 s hould not touch the
outer case due to expected rise in unit temperatur e.
4.2 Safety Overload
NOTE Do not exceed 30 minutes of continuous operation.
1. The motor of this device has a built-in thermal ove rload
protector. Should the motor overheat, the p rotector will automatically shut off the motor. Should thi s occur, turn the I/O (ON/OFF) switch to the O (OFF) position and allow the motor to cool down for approximately 30 minute s before turn it on again.
2. If the overload protector shuts off the moto r 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 immedia tely.
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 da ys 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
Page 2
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 nationa l 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 mon th and
replace as necessary or when filter turns gray. Please follow the below instructions a s right figures.
1. Open the filter cap.
2. Inspect the filter and if dirty, remove fi lter
with a small, pointed object. Discard the filter.
3. Replace with a clean filter. Additional f ilters
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 filt er.
7.3 Service
Except for the above instructed user main tenance, all device servicing must be performed by a Salter Lab s
®
authorized service representative. There are no serviceable parts inside the unit. Contact your Salter Labs dealer or authoriz ed service center if your unit needs repair.
WARNING Do not tamper with or attemp t to repair the device.
Refer servicing to qualified service per sonnel.
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 prob lem 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 dow n
may activate by built-in thermal protecto r, 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 E lite 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 chang e 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 Ra te
≧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: 10to 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-co ndensing
Storage: 10% to 90%RH non-condensing
Transport: 10% to 90% RH non-condensing
Atmospheric pressure
Operation: 700-1060 hPa
11. Accessories
Mo del Descrip tion
8501-1-2 Salter AIRE Elite Replacement filters 8258-0-1 Comp ressor 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 Manufacturer’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 Tes t
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 netw ork .
Harmonic emissions
IEC61000-3-2
Class A
Volta ge fluctuations /
Flicker
emissions
IEC61000-3-3
Complies
Guidance and Manufacturer’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-Guida nc e
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 .
Volta ge dip s, short interruptions and voltage variations on power supply input lines IEC61000-4-11
<5 % UT (>95 % dip in UT)for
0,5 cycle 40 % UT
(60 %
dip in UT) for 5 c yc les 70 % U
T
(30 %
dip in UT) for 25 cycles <5 % U
T
(>95 % dip in UT) for 5 sec
<5 % UT (>95 % dip in UT)
for 0,5 cycle 40 % UT
(60
% dip in U
T
)
for 5 cycles 70 % UT
(30
% dip in U
T
)
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: UT is 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 co ntrolled. The customer or the user of this device can help prevent electromagneti c interference by maintaining a minimum distance between portable and mobile RF communications equip ment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipmen t
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 Manufacturer’s Declaration - Elec trom agn eti c I mmu nity :
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 lev el
Compliance Electromagnetic
Environment-Guida nc e
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms150 kHz to 80 MHz ou tsi de IS M ba nds
a
3 V/m 80 MHz to 2.5 GHz
3 Vrms
3 V/m
Po rta b le a nd mo bi le 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 si te survey
c
, should be less than the compliance level in each frequency range
d
.
Interference may occur i n 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 additio nal factor of 10/3 is used in calcula ting 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: 661-854-3166 800-421-0024 (in CA) 800-235-4203 (outside CA) Fax: 661-854-3850 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 docume nts.
0086
800987 Rev D (Side 2) 666001-6720 V1. 0
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