Limited Warranty Global Medical Holdings (GMH) warrants the MaxiCompressor for 1 year from the date of purchase due to faulty parts or workmanship. This warranty is limited to the original purchaser of the compressor. Any defective part(s) or assembly will be repaired or replaced, at the sole discretion and determination of GMH, if the unit has not been misused or tampered with during the warranty period. Normal maintenance items, as outlined in this manual, and disposable components are not covered by this warranty. Shipping charges, if any, shall be paid by the purchaser. NOTE: There is no other express warranty. Implied warranties, including those of merchantability and fitness for a particular purpose, are limited to the duration of the express limited warranty and to the extent permitted by law and all implied warranties are excluded. This warranty does not cover providing a loaner compressor, compensating for costs incurred for compressor rental, or labor costs incurred in repairing or replacing defective part(s). MaxiCompressor™ High Performance 50 PSI Compressor 501-S CAUTION: USA Federal law restricts this device to sale by or on the order of a physician. P/N 21447-S Rev B 12 MaxiCompressor Table of Contents Introduction To treat your respiratory disorder, liquid medication or humidification treatment was prescribed to you by your physician. To ensure high quality treatment, you have made the right choice by purchasing the MaxiCompressor, manufactured by Global Medical Holdings (GMH). This powerful compressor has an operating pressure of 50 PSI, delivering up to 19 LPM of flow. It is capable of servicing nebulizers and humidifiers to produce fine quality particle aerosol mist, giving maximum benefit to the specific medications. Appendix 2: Technical Information Introduction 2 Attention MaxiCompressor User 3 Features & Controls 4 Operating Instructions 5 Cleaning & Maintenance 6 Troubleshooting 7 Important Precautions 8 Appendix 1 Technical Description 9 Appendix 2 Technical Information 10 Warranty 12 GUIDANCE AND MANUFACTURER'S DECLARATION: ELECTROMAGNETIC IMMUNITY The MaxiCompressor is intended for use in the electromagnetic immunity specified below. The customer or the user of the MaxiCompressor should assure that it is used in such an environment. Immunitytest IEC60601 testlevel +6kV contact +8kV air Compliance level +15kV contact +8kV air Electric fast transient/burst IEC 61000-4-4 +2kV for power supply lines +1kV for input/output lines +2kV for power supply lines +1kV for input/output lines Surge IEC 6000-4-5 +1kV for +1 kV Electrostatic discharge (ESD) IEC 61000-4-2 differential mode differential mode + 2kV common +2kV common mode mode Electromagnetic environment/guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. NOTE: Carefully read this manual before operating this device. Distributed by: 2 MaxiCompressor MaxiCompressor 11 Appendix 2: Technical Information ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Portable and mobile radio frequency (RF) communications equipment can affect devices such as the MaxiCompressor. As such, the device should not be used adjacent to other equipment. If this is not practical, then observe the device to make sure it is operating properly at all times. Attention MaxiCompressor User Toensureyourunitisproperlyused,pleasefollowthese additionalsteps. 1. The door on the 501 was designed to be used for shipping, transporting and or storing the unit. GUIDANCE AND MANUFACTURER'S DECLARATION: ELECTROMAGNETIC EMISSIONS The MaxiCompressor is intended for use in the electromagnetic environment specified below. The customer or the user of the MaxiCompressor should assure that it is used in such an environment. Emissionstest RF emissions CISPR 14 Compliance Group 1 RF emissions Class B CISPR 14 Harmonic emissions Class A lEC 61000-3-2 Voltage fluctuations/ Complies flicker emissions lEC 61000-3-3 Electromagneticenvironment/guidance The MaxiCompressor 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 MaxiCompressor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 2. When using the machine, remove the door by simply lifting up on the pin from the top and set the door and pin aside. 3. To reduce noise, please ensure the latch on the side of the unit is the in the latched position. 10 MaxiCompressor Unlatched MaxiCompressor 3 Latched Features & Controls Appendix 1: Technical Description 6 1 Switch SIZE: 13.5"L x 7"W x 14.5"H (34.3 cm x 17.8 cm x 36.8 cm) WEIGHT: 18 lbs. (8.16 kg) POWER REQUIREMENTS: 120 VAC, 60HZ, 6A OPERATIONAL PRESSURE: Continuous @ 50 PSI. NOTE: 50 PSI regulator may allow pressures > 65 PSI OPERATIONAL FLOW RATE: Minimum 19 LPM @ 50 PSI OPERATING TEMPERATURE: 50°F to 104°F (10°C to 40°C) MODE OF OPERATION: Continuous 5 Filter Cap SAFETY SYSTEMS: Automatic Resetting Thermal Limit Switch and two inline fuses. 6 Air Pressure Gauge EQUIPMENT CLASSIFICATION WITH RESPECT TO PROTECTION FROM ELECTRICAL SHOCK: ClassI 1 0=Off l=On 2 2 Outlet 4 3 Cord 7 3 7 5 4 Regulator DEGREE OF PROTECTION FROM ELECTRICAL SHOCK: TypeB 7 Fuses DEGREE OF PROTECTION AGAINST INGRESS OF LIQUIDS: IPX0-Ordinary NOTE,CAUTION,WARNINGSTATEMENTSANDSYMBOLS NOTE: Statements that provide supplementary information. CAUTION: Indicates the possibility of minor injury or damage to equipment. WARNING: Indicates the possibility of serious injury or death to yourself or others. Attention, consult accompanying documents. Handle with care Storage and Transportation Temperature Range Keep Dry 4 MaxiCompressor CONTINUOUS OPERATION AT TEMPERATURES 50°F to 104°F (10°C to 40°C) STORAGE AND TRANSPORTATION TEMPERATURE: -4°F to 140°F (-20°C to 60°C) This equipment is listed with a nationally recognized testing laboratory and classified with respect to electrical shock, fire, and mechanical hazards in accordance with the following standards: • UL 60601-1: 2003/04/25 Ed. 1 UL Standard for Safety Medical Electrical Equipment, Part General Requirements for Safety • CAN/CSA C22.2 No 606.1-M90 including Update No 2, November 2003, Reaffirmed 2005 • IEC 60601-1-2:2007 • IEC 61000-3-2:2006 • IEC 61000-3-3:1995 +A1:2001 +A2:2006 MaxiCompressor 9 Important Precautions This product is an electrical device. Always follow basic safety precautions when using this device including but not limited to the following: READTHISSAFETYCARDBEFOREUSING WARNING: To reduce the risk of burns, fire, electrocution, or other bodily harm or injury to persons: 1. Always unplug this device after each use. 2. Never submerse this product in water. 3. Never use this product while bathing, showering, washing dishes, or around water source of any kind. 4. Never leave this product unattended. 5. Use this product only for its intended use as described in the operator manual. 6. Closely monitor and supervise use by invalids and children. 7. Never block the air vent openings or allow objects to fall or to be inserted into the air vent openings. 8. Observe caution when using this product where oxygen is being administered. 9. If this product is being used in a life threatening situation, a backup unit is necessary. WARNING: This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Operating Instructions NOTE: Before starting, make sure the power cord is unplugged and the power switch is in the OFF (0) position. NOTE During high humidity weather conditions condensation water build up can occur, so it is recommended that you run the compressor for 2 minutes before the device is connected to the unit. 1. Set the MaxiCompressor on a level, sturdy surface so the controls of the unit can be easily reached and adjusted. 2. Connect the delivery device (nebulizer, humidifier) to the chromed medical outlet. 3. Plug in the compressor and turn the switch to the ON (l) position. 4. To adjust the pressure, gently pull the pressure regulator knob out of its “lock” position. Move the regulator knob clockwise to increase pressure or counter-clockwise to decrease pressure. Observe the PSI level on the unit’s gauge. When desired pressure is reached, “lock” the pressure knob with a gentle push. 5. At conclusion of treatment, power off the machine. A condensation trap is available - for more information contact Global Medical Holdings. NOTE Cold temperatures may result in poor compressor performance. Bring device up to room temperature for best results. WARNING To avoid the risk of possible electrical shock and damage to the compressor, the MaxiCompressor must be operated on the specified power source. The door should be removed before operation. To remove the door, grasp the hinge pin with pliers or fingers and pull gently upwards. To replace the door, line up the hinges on the door and on the case and carefully re-insert the hinge pin. (See page 3) CAUTION Do not move the MaxiCompressor when the nebulizer or the humidifier are still connected. Liquids may flow back through the device resulting in damage of the compressor. WARNING: This device is equipped with a hospital-grade cord and plug. Grounding reliability can only be achieved when the power cord is connected to an equivalent receptacle marked "Hospital Only" or "Hospital Grade". 8 MaxiCompressor MaxiCompressor 5 Troubleshooting Cleaning & Maintenance COMPRESSOR CLEANING: 1. Make sure the ON/OFF switch is in the OFF (0) position. 2. Unplug the compressor from the wall outlet. 3. Wipe compressor with a clean, damp cloth every 2-3 days. This will keep the unit dirt and dust free. 4. Allow compressor to completely dry before plugging into wall outlet. WARNING Never submerge the MaxiCompressor in water, hold under running water or spray with water or other liquids. This will result in compressor damage and possibility of electrical shock/ electrocution. INLET FILTER CARE: 1. Pry off the inlet filter cap with a small screw driver. 2. Remove the filter sponge and rinse it in warm, soapy water. Rinse the filter sponge in clean water. 3. Squeeze excess water from the filter sponge and allow it to air dry. Insert the filter into the housing, and install the filter cap. This should be done weekly. NOTE Maintenance guide with technical information is available through GMH upon request. FUSE CHANGE Make sure the switch is in the OFF (0) position and the device is unplugged before changing the fuse! The fuses are located on the front of the device. They protect the device from power surges that can occur in the home and from exposing this device to a wrong power source. To replace a fuse, unscrew the fuse holder on the front of the device. Take out the old fuse, insert the new fuse and screw the holder back on. WARNING Do not remove compressor case. Failure to comply could result in electrical shock. All disassembly must be carried out by an authorized GMH service center. DEVICE REPAIR Do not attempt to repair the device. Contact GMH Customer Service for assistance. (see Troubleshooting on page 7). 6 MaxiCompressor Symptoms Reduced air output 1. Dirty inlet filter. 2. Regulator improperly set. 3. Air leak. Compressor does not work Remedies Possible causes 1. Clean inlet filter - refer to cleaning section of this manual. 2. Set regulator following operating instructions. 3. Contact your dealer or the GMH service center. 1. Power cord not plugged in. 2. Defective switch. 1. Plug in the power cord. Compressor labors when device is used Plugged tubing or nebulizer. Replace tubing and nebulizer. Compressor runs but gauge reads zero Gauge reads line pressure; nebulizer needs connected to the tubing Connect the nebulizer to tubing. 2. Contact your dealer or the GMH service center. 3. Backed up pressure 3. Disconnect any in the compressor. device(s) connected to the unit and turn the machine on. 4. Blown fuse(s). 4. Check and replace any blown fuses (See pg. 6, Cleaning & Maintenance). MaxiCompressor 7