Sepray CPAP 25/CPAP A25 User Manual MICOMME MEDICAL 0123
micomme, Sepray,, are registered trademarks of Micomme Medical Technology Development Co., Ltd. All rights reserved. Modes: Sepray CPAP 25,Sepray CPAP A25 Manufacturer: Micomme Medical Technology Development Co., Ltd. Website: http://www.micomme.com Hotline: +86-4000-2000-33 Fax: +86-0731-89916333 E-mail: info@micomme.com 1 / 34
Table of Contents INTRODUCTION...4 INTENDED USE...4 CONTRAINDICATIONS:...6 ADVERSE EFFECTS...6 SYSTEM CONTENTS... 6 ACCESSORIES LIST... 7 SYSTEM OVERVIEW... 7 SYMBOLS... 9 USING THE DEVICE... 9 DEVICE SETTING...10 NAVIGATING THE DEVICE SCREENS...11 USER MODE:... 11 STANDBY SCREEN... 11 TREATMENT SCREEN...12 INFORMATION SCREEN...13 SETTING SCREEN... 13 PROVIDER MODE...14 TREATMENT PARAMETER SETTING... 14 CPAP 25 TREATMENT PARAMETER SETTING...14 2 / 34
CPAP A25 TREATMENT PARAMETER SETTING:...16 HUMIDIFIER...18 HUMIDIFIER SPECIFICATIONS:...18 INSTALLATION HUMIDIFIER...18 DEVICE ALERT... 20 ALERT SUMMARY TABLE:... 21 DEVICE CLEANING AND MAINTENANCE... 23 CLEANING HUMIDIFIER WATER CHAMBER...24 TROUBLESHOOTING... 24 TECHNICAL SPECIFICATIONS...26 PERFORMANCE PARAMETERS:...26 HUMIDIFIER PARAMETERS:...26 ENVIRONMENTAL...27 PHYSICAL AND ELECTRICAL CLASSIFICATION... 27 DISPOSAL...27 EMC INFORMATION... 28 LIMITED WARRANTY...33 3 / 34
Introduction Intended Use The Sepray CPAP 25 and CPAP A25 are Continuous Positive Airway Pressure devices designed for the treatment of Obstructive Sleep Apnea in spontaneously breathing adult patients. The patients weight should over 30kg. It is for use in the home or hospital. These devices should only be used with guidance of trained medical staff. Mask should be compatible for use as manufacturer recommended with the device. The system can deliver CPAP therapy or Auto CPAP therapy. Your home care provider will make the correct pressure settings according to your health care professional s prescription. WARNINGS: A warning indicates the possibility of injury to the user or the operator. This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professional s instructions regarding the use of the device. The operator should read and understand this entire manual before using the device. This device is not intended for life support. The device should be used only with masks and connectors recommended by MICOMME Co. or with those recommended by the health care professional. A mask should not be used unless the device is turned on and operate properly. The mask is treated as the applied part, which is not intended to deliver heat, during normal user, the maximum temperature of applied part maybe up to 42 C. Never block the exhalation port(s) associated with the mask. Do not use accessories, detachable parts and materials that manufacturer NOT recommended. That will degrade the device s performance. Do not arbitrary interconnect the device to other equipment not described in the instructions for use. Do not connect the device to high pressure oxygen supply source. When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen. The device should keep 1meter distance from oxygen supply at least. When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen off before turning the device off. This will prevent oxygen accumulation in the device. Oxygen accumulated in the device enclosure will create a risk of fire. Do not use the device near a source of toxic or harmful vapors. Do not use this device if the room temperature is higher than 35 C (95 F). If the device is used at room whose temperatures higher than 35 C (95 F), the temperature of the airflow may exceed 43 C (109 F). This could cause irritation or injury to your airway. Do not operate the device in direct sunlight or near a heating appliance because these 4 / 34
conditions can increase the temperature of the air coming out of the device. Do not operate the device in dusty environment, dust should occlude input filter, case some person allergy. If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use. Contact your home care provider. Repairs and adjustments must be performed by MICOMME -authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage. The patient is an intended operator, the patient should adjust parameters under user for safety. Do not service or maintain the machine while in use with the patient. No modification of this equipment is allowed. Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue to use and replace if damaged. The plug is used as disconnect to the mains supply, do not position the device so that it is difficult to operate the disconnection device. The separate power supply is specified as part of the device. Be sure to route the power cord in a right way that will prevent the cord from being tripped over or interfered with by furniture, prevent power cord twine neck cause strangulation. If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed in-line between the device and the circuit tubing to prevent contamination. And one person just use one set of disposable mask and tube. For safe operation when using the humidifier, the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device. The humidifier must be level for proper operation. The device blower design life is 15,000 hours. The accessories service life, please refer to the provider s instruction in the isolated package. CAUTIONS: A Caution indicates the possibility of damage to the device. Do not use this device if the room temperature is out of 5 C-35 C. Do not place the device directly onto carpet, fabric, or other flammable materials. Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter. Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly examine the device as needed for integrity and cleanliness. Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information. Contact your home care provider regarding EMC installation information. Mobile RF communications equipment can affect medical electrical equipment. Any assistance in setting up, using, maintaining, or report events, unexpected operation, please contact manufacturer or local manufacturer s representative. 5 / 34
Contraindications: If you have severe respiratory failure and can not even breath spontaneously, please do not use this device. If any of the following situations matches with you, please contact your professional health care staff before you use this machine: Respiratory drive is not sufficient to withstand intermittent therapy; Acute sinusitis, otitis media; Unable to clear secretions; Low blood pressure or obviously insufficient endovascular blood volume; Pneumothorax or pneumomediastinum; Brain trauma or surgery; Airway colostomy surgery; Bullous lung disease. Adverse Effects The following side effects may arise during the course of therapy with the device: Drying of mouth, nose or throat; Bloating; Ear or sinus discomfort; eye irritation; Skin rashes; Chest discomfort; System Contents Sepray CPAP 25, CPAP A25 System include: Main unit User manual Power cord Power supply Micro SD Card Carrying case Reusable gray foam filter Humidifier chamber Flexible tubing Mask (optional) NOTES: If any of these items are missing, please contact your home care provider. 6 / 34
Accessories list Micro SD Card Carrying case Reusable gray foam filter Humidifier chamber Flexible tubing Mask (optional) System overview 1. Alarm reset button 2. Ramp button 3. LCD screen 4. Wheel/Push control button 5. Air outlet port 6. Humidifier chamber 7 / 34
7. Humidifier cover 8. Unit shell 9. Unit bottom 10. Micro SD card 11. Interface cover 12. Power inlet 13. Air inlet/filter 8 / 34
Symbols Symbols Description Caution Type BF Applied Part Class II (Double Insulated) IP21 Water proof level: no protection, no special protection Do not disassemble. DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary. Ramp COMF function Humidifier start Yellow LED, medium priority alarm Red LED, high priority alarm Alarm off Alarm pause Alarm reset Using the device 1. Install the filter 9 / 34
CAUTION: The filter must be in place at all times when the device is operating. 2. Put your device on a firm, flat surface. NOTES: Suggested the device position is lower than your sleeping position. WARNING: Never block the air inlet when the device is operating! 3. Input Micro SD card NOTES: Micro SD card can storage the therapy data. The device can works normally without Micro SD card. 4. Add water into humidifier chamber and keep water line below the Max limited line. 5. Connect the tubing firmly onto the device air out let port; and connect the other end of tubing to the mask. CAUTION: Please refer to your mask instructions. 6. Plug power cord to the device power inlet socket. 7. Press the Wheel/Push control button to start or off the device. Device setting Sepray CPAP 25 and CPAP A25 have two operating : user and provider. User : users can change some parameters related to COMF by themselves. Provider : medical professionals should use this adjust all therapy parameters. WARNING: 10 / 34
Only medical professionals should be allowed to use this to adjust pressure settings. Provider unlocks settings that cannot be modified by the user. Navigating the Device Screens User : 1. Make sure power is on, the device enter standby screen. 2. Use the Wheel/Push control button move the cursor on [Sys.] soft key to set parameters. 3. Use the Wheel/Push control button move the cursor on [Treat] soft key to start or off the device. Standby screen 11 / 34
Treatment screen : Real time display CPAP pressure 12 / 34
Information screen Setting screen 13 / 34
Provider 1. Make sure power is on, the device enter standby screen. 2. Use the Wheel/Push control button move the cursor on [Sys.] soft key. 3. Press the Ramp button and press the wheel button simultaneously, then, release all button, the device enters provider. NOTES: When you enter the provider, the [Treat] soft key display changes to [Back]. 4. Exit provider, move cursor on [Back], press wheel button exit to user. Treatment parameter setting CPAP 25 treatment parameter setting Parameter Range Description Mode BACK return to previous menu User /Provider Mode CPAP CPAP :Continuous Positive Airway Pressure CPAP 4 ~ 20 cmh2o Setting Continuous Positive Airway Pressure. COMF On/Off Turn on or turn off the COMF function Provider Provider User /Provider COMF Level 1 ~ 3 level Adjust COMF level from 1 to 3, COMF effect will increase synchronously. Note: The parameter is visible only User /Provider when COMF is ON. Ramp Time Off ~ 45 min Set pressure ramp time from User /Provider 14 / 34
0-45 min Ramp Pressure 4 cmh2o ~ CPAP Set ramp start pressure. User /Provider Humidifier OFF ~ 5 level This setting allows you to choose the desired humidity setting level. User /Provider Auto On Off/On ON: when you fit your mask and normal breath several times, the device will automatically turn the User /Provider airflow on. Auto Off Off/On ON: when you remove your mask 2 minutes, the device will automatically turn to standby status. User /Provider Mask Alert Off/On ON: When the circuit is disconnected or there is a large air leak in mask,mask alert function User /Provider available. LED Backlight Auto/On Auto: Display LCD automatics turn to dark, (Nobody touches any button in 5 minutes). User /Provider ON: Display LCD always lighting. Language English/Chinese Choose language User /Provider Reset Factory Set Off/On ON: Reset to Factory setting Provider Memory Space Micro SD Card Memory Space User /Provider Version Device soft version User /Provider 15 / 34
CPAP A25 treatment parameter setting Parameter Range Description Mode Back Return to previous menu User /Provider Mode CPAP Auto CPAP CPAP : Continuous Positive Airway Pressure Auto CPAP : Device adjusts CPAP pressure automatically based Provider Max Pressure Min Pressure ~ 20 cmh 2O on monitoring of patient s Obstructive Sleep Apnea, hypopnea, and snoring etc. events. Set highest limit of variable CPAP during auto CPAP Provider Min Pressure 4 cmh2o ~ Max Pressure Set lowest limit of variable CPAP during auto CPAP Provider COMF On/Off Turn on or turn off the COMF function User /Provider COMF Level 1 ~ 3 level Adjust COMF level from 1 to 3,COMF effect will increase synchronously. Note: The parameter is visible only User /Provider when COMF is on. Ramp Time Off ~ 45 min Set pressure ramp time from 0-45min User /Provider Ramp Start 4 cmh2o ~ Min Set ramp start pressure. User /Provider Pressure Humidifier Off ~ 5 level This setting allows you to choose the desired humidity setting level. User /Provider 16 / 34
Auto On Off/On ON: when you fit your mask and normal breath several times, the device will automatically turn the User /Provider airflow on. Auto Off Off/On ON: when you remove your mask 2 minutes, the device will automatically turn to standby status. User /Provider Mask Alert Off/On ON: When the circuit is disconnected or there is a large air leak in mask,mask alert function User /Provider available. LED Backlight Auto/On Auto: Display LCD automatics turn to dark, (Nobody touches any button in 5 minutes). User /Provider ON: Display LCD always light. Language English/Chinese Choose language User /Provider Reset Factory Set OFF/ON ON: Reset to Factory setting Provider Memory Space Micro SD Card Memory Space User /Provider Version Device soft version User /Provider 17 / 34
Humidifier Sepray CPAP 25, CPAP A25 standard configuration include humidifier. Humidifier specifications Voltage: 24 VDC Heated plate Max power: 45 W Chamber capacity: 270 ml Maximum pressure:30 cm H 2O Input air temperature s range: 15 to 30 C Static water temperature range: 35~45(±5) C Preheating time: less than 60 minutes Heating plate thermal fuse: 125±10 C Humidifying ability: more than 10 mg/l Leakage: less than 20 ml/min (maximum operating pressure: 20 cmh 2O) Installation humidifier 1. Rotate humidifier cover counterclockwise to unlock it. 18 / 34
2. Pull up the cover. 3. Push out the water chamber 19 / 34
4. Inject distilled water as the direction of arrow. 5. Push water chamber back into main unit, install and rotate cover clockwise to locked position, according to steps 1-4 in reverse operation. WARNING: Always ensure humidifier water level under the limited mark. Don t touch the humidifier heated plate. The heated plate working temperature sometimes over 80 C. It may scald your skin. CAUTION: When you want to add water in humidifier chamber, please removie the chamber outside the device first. Wipe the chamber housing outside water, keep it dry before you install it back to device. Device Alert High Priority: These alerts require immediate operator response. The alert signal consists of a high priority sound. Audible indicator is a continuous three-beep and two-beep pattern ( 20 / 34
). Visual indicator is red alarm symbol flash. Low Priority: These alerts require prompt operator response. No need audible indictor. Visual indicter is yellow prompt symbol illuminated. Alert Summary Table The following table summarizes the alerts Alert type Alert Error code Description Possible Cause Patient Action Turn off the device. Remove Blower failure E101 Blower problem Blower hall sensor can not detect blower is running the power cord from the device. Plug the cord back into the device s power inlet to restore power. If the alert continues to occur, contact your home care provider Humidifier Humidifier Turn off the device and High Priority Alert Humidifier failure E102 heated plate temperature too high heated plate temperature exceed 90 C. contact your home care provider Turn off the device. Remove the power cord from the Pressure sensor failure E103 Pressure sensor failure Pressure sensor failure device. Plug the cord back into the device s power inlet to restore power. If the alert continues to occur, contact your home care provider Flow sensor failure E104 Flow sensor failure Flow sensor detected wrong Turn off the device. Remove the power cord from the 21 / 34
data over 30 seconds. device. Plug the cord back into the device s power inlet to restore power. If the alert continues to occur, contact your home care provider Device Pressure sensor Turn off the device and High output detected output contact your home care pressure E105 pressure too pressure exceeds provider alert high 35 cmh 2O over 6 seconds. Check your mask and tubing. Tubing disconnect E106 Tubing disconnect Pressure sensor detects output pressure is less than 0.5 cmh 2O over 30 seconds. Check breathing circuit connections and reconnect the tubing if it has came loose. If the alert continues to occur, contact your home care provider. Flow sensor Check breathing circuit, Tubing obstruction E107 Tubing obstruction detect airflow is zero over 30 make sure no obstruction. seconds. Mask huge Check your mask and tubing Mask Alert E108 leakage Flow sensor detects airflow exceeds 80L/min if it has some damage. Maybe you should refit your mask. over 60 seconds. 22 / 34
Storage card Contact your home care Low Storage card full E201 full Storage card is full. provider to download therapy data, or exchange for Priority one new storage card. Alert Storage card removed E202 Storage card has been removed. No storage card Insert an available card. Device cleaning and maintenance Clean the flexible tubing before first use and daily use. Clean the mask first use and daily use. For the mask and flexible tubing, gently wash the tubing in a solution of warm water and a mild detergent. Rinse thoroughly. Air dry. Use soft cloth to clean the device surface. Clean the foam filter at least once every two weeks and replace it with a new one every six months. Clean the humidifier water chamber once every two weeks. Suggest replace the mask every 6 months to 12 months according to the smudgy degree, or follow your mask provider s instruction The device does not require routine servicing. CAUTION: Do not attempt to open the device. There are no user serviceable parts inside. WARNING: If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if water is spilled into the enclosure, if the enclosure is broken, disconnect the power cord and discontinue use. Contact your home care provider. The degraded sensors, electrodes, blower, or loosened connector should cause some problems, degrade device performance. Inspection and repair should only be performed by Micomme authorized agent or engineers. 23 / 34
Cleaning humidifier water chamber You can open the water chamber s cover and cleaning chamber inside. CAUTION: After refit the chamber, you should confirm the cover refit tightness. No air leakage. Troubleshooting The table below lists some of the problems you may experience with your device and possible solutions to those problems. 24 / 34
Problem Possible Cause Solution Make sure there is power available at the outlet. Make sure the AC power cord is connected Nothing happens when you apply power to the device. Display screen is dark. The airflow is much warmer than usual Device output air pressure cannot reach the set CPAP pressure. Huge leakage. The airflow pressure feels too high or too low. WARNING: No power at the outlet or the device is unplugged The air filter may be dirty. The device may be operating in direct sunlight or near a heater. Humidifier settings is not correct. Air leak Mask defect Device settings is not correct correctly to the power supply and the power supply cord is securely connected to the device s power inlet. If the problem continues to occur, contact your home care provider. Return both the device and power supply to your provider. Clean or replace the air filters. Keep the device away from bedding or curtains that could block the flow of air around the device. Make sure the device is away from direct sunlight and heating equipment. Check the humidifier settings. If the problem continues, contact your home care provider. Adjust or re-fit cushion and headgear. If necessary, change the mask. Check humidifier chamber leakage, refit the chamber cover. Replace the defected mask Contact your home care provider to ensure your correct therapy parameters. Inspection and repair should only be performed by Micomme authorized agent or engineers. 25 / 34
Technical Specifications Performance parameters Parameters Range Accuracy Factory default setting CPAP 4 cmh2o - 20 cmh2o ±2 cmh2o CPAP : 10 cmh2o Ramp Time 0-45 min ±10% 20 min Ramp Pressure Inspiratory Impedance Exhalation Impedance 4 cmh2o - 20 cmh2o (less than setting CPAP) <1 cmh 2O @30 L/Min; <6 cmh 2O @60 L/Min <1 cmh2o @30 L/Min; <6 cmh 2O @60 L/Min 4 cmh2o Maximum Pressure Flow 20cmH 2O 102 L/min @ 10 cmh2o 115 L/min @ 20 cmh 2O ± 2 cmh2o ±10 L/min Sound Pressure 30 db(a) ±5 db(a) Level Humidifier parameters Parameters Condition Range (accuracy) Humidifier Capability Air flow 20L/min 40 L/min >10 mg/l Pressure Drop 60 L/min < 2 cmh2o Humidifier Compliance N/A < 0.6 ml/kpa Maximum Temperature Maximum State Pressure N/A N/A < 125 (±10 ) 40 cmh 2O 26 / 34
Leakage 20 cmh 2O < 20 ml/min Environmental Parameters Operating Storage Temperature 5ºC ~ 35ºC -20ºC ~ 70ºC Relative Humidity 15% ~ 93%(Non condensing) 0~ 93% (Non condensing) Atmospheric Pressure 700 hpa ~ 1060hPa 500hPa ~ 1060hPa Physical and Electrical Classification Parameters Dimensions Weight AC Power AC current DC Power DC current Protection against electrical shock. Electric shock protection Degree of protection against liquids Sterilization requirement Category equipment Mode of operation Value 24.5 cm L x 16.0 cm W x 10.5cm H 1.82kg 100 ~ 240VAC, 50/60 Hz 1.8 A (Max) 24 V 3.33 A (Max)) II BF IP21 No AP/APG Continuous Disposal Do not dispose of electrical appliances as unsorted municipal waste, use separate collection facilities. Contact your local government for information regarding the collection systems 27 / 34
available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being. EMC information WARNING: The appliance needs special precaution regarding EMC and needs to be installed and put into service according to the EMC information provided in the below tables. The appliance needs to be installed and put into service in accordance with the information provided in the accompanying documents. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this applicable and should be kept at least a distance d away from the appliance. The distance d is calculated by the manufacturer from the 800 MHz to 2.5 GHz column of tables in the below. - Guidance and manufacturer s declaration electromagnetic immunity The l CPAP 25/A25 is intended for use in the electromagnetic environment specified below. The customer or the user of the l CPAP 25/A25 should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kv contact 6 kv contact Floors should be wood, concrete or discharge (ESD) 8 kv air 8 kv air ceramic tile. If floors are covered with IEC 61000-4-2 synthetic material, the relative humidity should be at least 30%. Electrical fast 2 kv for power 2 kv for power Mains power quality should be that of transient/burst supply lines supply lines a typical commercial or hospital IEC 61000-4-4 environment. 28 / 34
Surge 1 kv differential 1 kv differential Mains power quality should be that of IEC 61000-4-5 a typical commercial or hospital environment. Voltage dips, short <5% UT <5% UT Mains power quality should be that of interruptions and (>95 % dip in UT) (>95% dip in UT) a typical commercial or hospital voltage variations for 0,5 cycle for 0,5 cycle environment. If the user of the l on power supply CPAP 25/A25 requires continued input lines 40% UT 40 % UT operation during power mains IEC 61000-4-11 (60% dip in UT) (60% dip in UT) interruptions, it is recommended that for 5 cycles for 5 cycles the l CPAP 25/A25 be powered from an uninterruptible power supply 70% UT 70% UT or a battery. (30% dip in UT) (30% dip in UT) for 25 cycles for 25 cycles <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 5 sec for 5 sec Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 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 a.c. mains voltage prior to application of the test level. 29 / 34
Guidance and manufacturer s declaration electromagnetic immunity The l CPAP 25/A25 is intended for use in the electromagnetic environment specified below. The customer or the user of the l CPAP 25/A25 should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the l CPAP 25/A25, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 khz to 80 MHz 3 V d=1.2 P d=1.2 P 80MHz to 800MHz d=2.3 P 800MHz to 2.5 GHz Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a 30 / 34
should be less than the compliance level in each frequency range. b 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 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 l CPAP 25/A25 is used exceeds the applicable RF compliance level above, the l CPAP 25/A25 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the l CPAP 25/A25. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than [V1] V/m. Guidance and manufacturer s declaration electromagnetic emissions The l CPAP 25/A25 is intended for use in the electromagnetic environment specified below. The customer or the user of the l CPAP 25/A25 should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance The l CPAP 25/A25 uses RF energy only for its RF emissions CISPR 11 Group 1 internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. 31 / 34
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Class B Class A Complies The l CPAP 25/A25 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. Recommended separation distances between portable and mobile RF communications equipment and the l CPAP 25/A25. The l CPAP 25/A25 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the l CPAP 25/A25 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the l CPAP 25/A25 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m Rated maximum output power of transmitter 80 MHz to 800 MHz 800 MHz to 2,5 GHz W 150 khz to 80 MHz 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 32 / 34
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. Limited Warranty Micomme Co. warrants that the main system unit shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two (2) years from the date of sale by Micomme Co. to the dealer. If the product fails to perform in accordance with the product specifications, Micomme Co. will repair or replace the defective material or part. This warranty does not cover damage caused by accident, misuse, abuse, alteration, water ingress, or other defects not related to material or workmanship. This warranty period does not include the accessories which are not manufactured by Micomme Co. (Such as Mask, tubing etc.) This warranty claims on defective product must be made by the initial consumer at the point of purchase. Micomme disclaims all liability for economic loss, loss of profits, overhead, or consequential damages which may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not applicable to you. This warranty is given in lieu of all other express warranties. In addition, any implied warranties including any warranty of merchantability or fitness for the particular purpose are limited to two years. 33 / 34
Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region. To exercise your rights under this warranty, contact your local authorized Micomme Co. dealer or contact Micomme Medical Technology Development Co., Ltd. MANUFACTURER: Micomme Medical Technology Development Co., Ltd. Address: Room101-102, North 1 st Floor, Superstar Enterprise Center, No8, Lujing Road, High-Tech Zone, 410205, Changsha, Hunan, PEOPLE S REPUBILIC OF CHINA Website: http:/www.micomme.com Hot line: +86-4000-2000-33 Fax: +86-0731-89916333 E-mail: info@micomme.com EU AUTHORISED REPRESENTATIVE: Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726 34 / 34