SALTERS LABS
AIRE Elite Compressor Model 8350 -1, 8352-1 and 8353-1 Instruction Manual Rev B Printed Oct 2014
Instruction Manual
2 Pages
Preview
Page 1
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.
Instruction Manual Part No: 8350-1 / 8352-1 / 8353-1
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.
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
800987 Rev B (Side 1)
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 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 Printed on 16 October 2014
instructions supplied with your nebulizer 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
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity:
10. Specifications
(All specifications are subject to change without notice.)
Electrical Rating (Note: Refer to the rating label on the product) Maximum Compressor Pressure Nebulizer Flow Rate
120VAC,60Hz,1.2A ( For 120V System)
230VAC,50Hz,0.6A ( For 230V System)
≧30 psi ≧5.5 lpm ≧5.0 lpm Class II. BF equipment. IP2X No AP/APG protection.
Keep the unit and accessories dry. Avoid direct sunshine. See specifications in Section 10 for appropriate environmental storage conditions.
Classification
7. Maintenance
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
7.1 General Information 1. 2.
This unit is oil-less. Do Not Lubricate. 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 Device doesn’t operate.
Weak Nebulization
Cause and Solution ‧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. ‧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.
800987 Rev B (Side 2)
Fuse (non-user serviceable) F5AL 250V Warranty
T1.6AL 250V
5 Years Operation: 10℃ to 40℃/ 50℉ to 104℉ Temperature Storage: -15℃ to 50℃ / 5℉ to 122℉ Transport: -15℃ to 70℃/ 5℉ to 158℉ Operation: 10% to 90%RH non-condensing
Environment Humidity
Storage: 10% to 90%RH non-condensing Transport: 10% to 90% RH non-condensing
Atmospheric Operation: 700-1060 hPa pressure
11. Accessories Model 8501-1-2 8258-0-1 8660 8960 8967 8984 8900 8906 8924
Description Salter AIRE Elite Replacement filters Compressor Carrying bag NebuTech® Nebulizer – Reusable NebuTech Nebulizer – Disposable NebuTech Nebulizer with Pediatric Mask NebuTech Nebulizer with Adult Mask Nebulizer with Tee Adapter Nebulizer with Pediatric Mask 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 Test
Compliance
RF emissions CISPR 11
Group1
RF emissions CISPR 11
Class B
Harmonic emissions
Class A
IEC61000-3-2 Voltage fluctuations / Flicker emissions IEC61000-3-3
Complies
Electromagnetic Environment-Guidance 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
The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network.
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
Electrostatic ±6kV contact Discharge (ESD) ±8kV air IEC61000-4-2
Compliance
Electromagnetic Environment-Guidance
±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%.
±2kV for ±2kV for power Mains power quality Electrical fast power supply supply line should be that of a typical transient/ burst line ±1kV for commercial or hospital IEC61000-4-4 ±1kV for input/out line environment. input/out line ± 1 kV line(s) to ± 1 kV line(s) Mains power quality Surge line(s) to should be that of a typical IEC61000-4-5 ± 2 kV line(s) to line(s) commercial or hospital earth environment. <5 % UT (>95 % <5 % UT (>95 Mains power quality dip in UT)for 0,5 % dip in UT) should be that of a typical Voltage dips, cycle for 0,5 cycle commercial or hospital short 40 % UT (60 % 40 % UT (60 % environment. If the user of interruptions dip in UT) dip in UT) for 5 this device requires and voltage for 5 cycles cycles continued operation variations on 70 % UT (30 % 70 % UT (30 % during power mains power supply dip in UT) dip in UT) for interruptions, it is input lines for 25 cycles 25 cycles recommended that the IEC61000-4-11 <5 % UT (>95 % <5 % UT (>95 device be powered from dip in UT) for 5 % dip in UT) an uninterruptible power sec for 5 sec supply or a battery. Power frequency magnetic Power fields should be at levels frequency characteristic of a typical (50/60Hz) 3 A/m 3 A/m location in a typical magnetic field commercial or hospital IEC61000-4-8 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 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 Separation distance according to frequency of transmitter (m) Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz power
d 1.2 P
d 1.2 P
d 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10 100
3.8 12
3.8 12
7.3 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 - 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-Guidance
Portable and mobile RF 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 Conducted 3Vrms150 kHz RF to 80 MHz outside ISM IEC a 61000-4-6 bands
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 Vrms
d 1.2 P 150kHz to 80MHz d 1.2 P 150kHz to 80MHz d 2.3 P 80 MHz to 2.5G MHz
3 V/m
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: 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 0086 D-66386 St. Ingbert, Germany NOTE Consult distributor(s) or EU representative(s) for additional technical documents. 666001-6720 V1.0