Transcend Heated Humidifier™ User Manual
Contents
1. dip In Ur for 5 cycles User Manual Compliance N A The HH does not have conductive Surfaces t2 4 6 8 KV air 2 kV for power Supply lines 1 kV for input output lines 0 5 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ut for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ut 30 dip in Ur for 25 cycles Page 18 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 Line power quality should be that of a typical commercial or hospital environment Line power quality should be that of a typical commercial or hospital environment Line power quality should be that of a typical commercial or hospital environment If the user of the CPAP system requires continued operation during power line interruptions it is recommended that the CPAP system be powered from the battery Note Ur is the A C line voltage before application of the test level Page 19 Immunity test Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 test level 70 Ur 30 dip in Ut for 25 cycles lt 5 gt 95 dip in Ur for 5 sec 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Compliance lt 5 Ur gt 95 dip in Utfor 5 sec 3 Vr2. 100 240V 50 60Hz Water Reservoir Volume up to maximum 325 mL fill level Working Pressure Range 4 to 20 cm H O Warm up time Up to 1 hour depending on heat setting Inspiratory Expiratory Pressure Drop 0 375 cmH20 50 LPM Liters per Minute Gas Leakage of the Humidification 4 85 LPM System at max operating pressure Maximum Gas Temperature 77 F 25 C Sound power level 10 cmH gt 0 pressure static 37 0 dB Sound pressure level 10 cmH gt 0 pressure static 29 0 dB Maximum heater plate temperature 131 F 55 C Humidifier Performance Testing Completed at 20 C Elevation 800 ft CPAP Pressure Relative Humidity Nominal System Setting Output mg L 4 cmH gt 0 12 cmH gt 0 M Page 15 Transcend Heated Humidifier User Manual 20 cmH20 This device was not evaluated up to 8000 feet of elevation Storage and Transport Temperature Range 4 140 F 20 60 C Humidity Range 10 90 RH Caution Empty the water reservoir before traveling with the heated humidifier Operating Conditions Ambient Temperature Range 41 95 F 5 35 C Gas Inlet Temperature Range 41 95 F 5 35 C Humidity Range 10 80 RH Caution Humidity performance may be compromised if used outside the defined ambient temperature range and humidity range Troubleshooting Problem Probable Cause Solution Humidifier does not Incorrect setup 1 Ensure that you have the fully seated the PAP turn on device into the
3. therapy General warnings Note Specific warnings and cautions appear throughout the manual within relevant sections e Use the Humidifier only for its intended use as defined in this User Manual e Only use Transcend positive airway pressure devices and a 6 foot air supply tube with the Humidifier e The Humidifier is for single patient re use and must not be re used on another person This is to avoid the risk of cross infection e Always place the Humidifier lower than the level of the patient If it is placed at or above the level of the patient heated water may flow down the air tubing and into the mask e Take care when handling the Humidifier The water in the reservoir may be hot e If liquids are spilled on the Humidifier disconnect the power cord immediately discontinue use and contact your service provider e Do not modify this equipment without authorization of the manufacturer e The Humidifier Water Reservoir must be completely drained of water prior to transport Water remaining in the Water Reservoir may leak during transport damage the electrical circuitry of the device and create a potential electrical shock hazard Transcend Heated Humidifier User Manual Page 4 e Do not use a modified sine wave power inverter to power the humidifier e Do not use the Humidifier in the presence of flammable or explosive materials e Medical electrical equipment including this device require special precautions regarding ele
4. Heated Humidifier and that you have pressed the PAP power button Be sure the PAP device and Heated Humidifier are connected to power Humidifier does not Incorrect setup Ensure that you have followed the correct heat the Water setup The middle green LED will indicate that Reservoir the Heated Humidifier is warming the Water Reservoir It may take up to 45 seconds to reach the desired temperature M Transcend Heated Humidifier User Manual Page 16 Problem Probable Cause Solution PAP device turns on but Massive air 1 Ensure that the air supply hose is fully then stops working The red LED is illuminated on the Humidifier Water is splashing on your face Air does not feel moist Air feels too moist Leaking Water Reservoir leak causing system to shut down Water supply is low or water reservoir IS detached from the humidifier The Water Reservoir is overfilled The settings knob is set too high causing condensation to form in the air tube and mask The settings knob is set too low The heater is not working The settings knob is set too high Water Reservoir may be cracked or damaged The lid may not be on correctly connected to the Heated Humidifier and to your mask Securely fit the mask to your face before powering up the PAP device Be sure the Water Reservoir gasket is in place and the Water Reservoir cover is fully seated Ensure the PAP dev
5. Minnesota 55112 USA 1 877 621 9626 or 1 651 621 1800 Somnetics International Inc 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA http www mytranscend com Phone 651 621 1800 Toll free 877 621 9626 Fax 651 204 0064 Transcend Heated Humidifier User Manual 103404 Rev G
6. TEE T 1 EE NE 8 EB ED NG 8 alia tugi g S M ETT S LO LL ILLI LM 10 and EE EE NE MN 10 SJELA CO NN MN MMS ME EE ENE 13 FEN 13 Tecno SCE COONS NE EE 13 AE FN NENNE 14 9 2G Tran 20 EE EE EE ER ER 15 ODIO Eae pees ae EE NE 15 ide islam a en NE ee GUN UN 15 Electromagnetic eg EE EE ET 17 Eie c Tomo sea EE EE EE eer T 17 Wa EEE EE E E E E EE a 20 M Page 3 Transcend Heated Humidifier User Manual Introduction Thank you for choosing the Transcend Heated Humidifier Humidifier designed to be used with Transcend positive airway pressure PAP therapy devices to humidify the air delivered during therapy Dry air may cause nasal congestion or dryness of the nose mouth or throat during sleep apnea therapy especially in dry or cold climates and in cases of air leakage through the mouth Humidifying the air may help relieve these symptoms and make therapy more comfortable Please read all instructions prior to use Intended use The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend PAP therapy device The Humidifier is intended for single patient re use in the home and hospital institutional environment The Humidifier is for use only as recommended by a physician Contraindications Please refer to the Transcend User Manual provided with your PAP device for contraindications associated with positive airway pressure
7. TRANSCEND Transcend Heated Humidifier User Manual M Page 1 Transcend Heated Humidifier User Manual S t i Revised Transcend Heated Humidifier User Manual 103404 Rev G Published August 26 2014and supersedes all previous versions Notice The information contained in this document is subject to change without notice Trademark Somnetics and Transcend are registered trademarks of Somnetics International Inc all rights reserved Copyright Copyright 2014 Somnetics International Inc all rights reserved Contact Somnetics International Inc Corporate headquarters Somnetics International Inc Email info somnetics com Web http www mytranscend com Telephone 651 621 1800 Toll free telephone 877 621 9626 Fax 651 204 0064 Somnetics International Inc 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA Authorized Representative MDD 93 42 EEC Atlantico Systems Ltd 0086 34 Oldfield Kingston Galway Ireland TEL 35391443609 Transcend Heated Humidifier User Manual Page 2 Contents MT 3 E T I NE E E OE EE 3 COE O EE UTENTE 3 ATNA 3 PN NN 5 Transcend Heated Humidifier comiDbolel Tlaxcala maken Using the Transcend Heated Humidifier Larsnes RU UNE S 7 Setting up your FTO ANE keen ESSO dn ER IR Far 7 Filling the water 7 se the a
8. ctromagnetic compatibility EMC and needs to be installed placed and used according to EMC information e Radiofrequency RF communications equipment can effect medical electrical equipment including this device e Other cables and accessories may affect EMC performance e careful when placing or stacking this humidifier close to or on top of other equipment M Page 5 Transcend Heated Humidifier User Manual Symbols Attention consult accompanying documents Type BF Applied Part TYPE BF ETL Classified ETL Seal of Approval demonstrating quality safety and professional manufacturing of medical product Listed Intertek Upper and lower temperature limits Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Waste Electrical and Electronic Equipment WEEE 7 Consult instructions for use 7 Upper and lower humidity limits d Non condensing E Class II medical electrical equipment Caution Federal Law United States restricts this device to sale by on the order of O a Physician nly Precedes reference or item number Transcend Heated Humidifier User Manual Page 6 Transcend Heated Humidifier Components ITEM DESCRIPTION WATER RESERVOIR HUMIDIFIER BODY SETTINGS KNOB POWER INPUT FILL CAP 2 PRONG POWER CORD RESERVOIR DRAIN PLUG M Page 7 Transcend Heated Humidifier User Manual Using the Transcend Heated H
9. erial or workmanship Somnetics will pay customary freight charges from Somnetics to dealer location only Somnetics 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 its products Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including warranty of merchantability or fitness for the particular purpose are limited to the period noted in the table above for the individual product Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty gives you specific legal rights and you may also have rights which vary from state to state To qualify for repair replacement or refund the defective device must be returned to Somnetics within 30 days after the discovery of the defect Proof of purchase including proff of the date of purchase is required Any repair replacement or refund obligation would not apply if the device has been repaired or otherwise altered in a facility not authorized in writing by Somnetics To exercise your rights under this warranty contact your local authorized Somnetics dealer or Somnetics at 33 5th Avenue New Brighton
10. g the Humidifier from the power source and remove the Transcend PAP device before cleaning the humidifier Allow the Humidifier to dry completely before plugging it back into a power source Warning The Water Reservoir is the only part of the Heated Humidifier that should be submerged in water Never submerge any other part of the Humidifier in water Do not allow water to enter the interior of the Humidifier Body In the event water enters the interior of the Humidifier Body wipe the surfaces dry of water using a lint free cotton cloth and allow to fully air dry before plugging it back in to a power source Servicing No further maintenance is required Do not open the Humidifier Body There are no serviceable parts inside Repairs and servicing should only be performed by a service agent authorized by the manufacturer It is recommended the water reservoir P N 503080 be replaced every 6 months Replacement Parts and Accessories Item Part Item Part Number Number Water Reservoir Assembly 503080 US 2 Prong Power Cord 503074 Transcend Heated 503064 UK 2 Prong Power Cord 503076 Humidifier EU 2 Prong Power Cord 503075 AU 2 Prong Power Cord 503077 Water Reservoir Drain Plug 503083 HEN ROET ANE gg Travel Bag Technical Specifications Dimensions LxWxH 9 in x 5 5 in x 4 7 in Weight 2 2 Ibs 998g empty 3 1 Ibs 14069 with water to the max fill line Transcend Heated Humidifier User Manual Page 14 AC Supply Input
11. green to indicate that the Humidifier is heating the Water Reservoir and is delivering humidification Image 7 Note The Humidifier temperature setting must be in the range of 1 to 5 to initiate warming A temperature setting of O will turn off the heating function of the Humidifier Transcend Heated Humidifier User Manual Page 10 Note The Humidifier will not begin warming the Water Reservoir until the PAP device power button has been pressed and the PAP device is in Therapy Mode It may take up to 60 minutes to reach the set Humidifier temperature depending upon the selected heat setting Note If a fault has occurred with the humidifier all three LEDs will begin to flash Please refer to the troubleshooting section of this user manual for more information 5 Adjust the heat setting by using the dial located on the back of the Humidifier Image 8 Note Heated humidification can be adjusted to a level of 0 to 5 The 0 setting will turn the heating function to off A setting of 5 provides the highest level of humidification If a heat setting has been recommended by your physician begin at that setting and then adjust the dial up or down to reach your humidification comfort level Warning Place the Humidifier at a level that is lower than your sleeping position to prevent condensation from collecting in air supply tubing and patient interface Avoid using a heat setting that may result in the collection of condensat
12. h a solution of 5 Image 11 mild liquid detergent in distilled water 1 6 fl oz liquid detergent per quart of distilled water Image 12 e Replace Fill Cap e Cover the output port with your hand and gently shake the Reservoir back and forth for 10 seconds M Transcend Heated Humidifier User Manual Page 12 e Remove the Drain Plug and drain the solution Image 13 e Replace the Drain Plug e Open the Fill Cap and rinse the inside of the Reservoir thoroughly with clean water Image 13 e Remove the Drain Plug to empty the Reservoir Note Repeat steps as needed to remove excess solution e Return the reservoir to the Humidifier Body Image 14 e To fully dry the Reservoir turn on Drying mode by pressing and holding the ramp button then the power button on the Transcend PAP device Drying mode will last for 30 minutes and turn off automatically Image 15 Note Ensure that power is supplied to the Transcend PAP device and Humidifier e Refill the Reservoir with distilled water before the next use c Weekly Maintenance Inspect the Water Reservoir and Fill Cap for wear or deterioration If the Water Reservoir begins to leak replace it immediately with a new Reservoir Contact your home medical equipment provider or call Somnetics customer service at 1 877 621 9626 for assistance M Page 13 Transcend Heated Humidifier User Manual Warning To avoid the potential for electric shock unplu
13. humidifier system is used exceeds the applicable RF compliance level above the humidifier system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the system Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m EN 60601 1 compliance Protection against electric shock Class II Type BF Degree of protection against ingress of water IP21 Warranty Somnetics warrants its products to be free of defects in materials and workmanship and will perform in accordance with the product specifications for a period specified in the following table Product Warranty Period Transcend Starter System Transcend Auto System Transcend EZEX System Transcend Heated Humidifier Transcend P4 and P8 Batteries Transcend Portable Solar Charger Transcend Mobile Power Adaptor Transcend LCD Programming Base 2 years Station From date of user purchase Except water reservoir which is warranted for 6 months M Page 21 Transcend Heated Humidifier User Manual If the product fails to perform in accordance with the product specifications Somnetics will repair or replace at its option any materials or parts of the product which upon Somnetics examination appear defective This warranty does not cover damages caused by accident misuse abuse alteration and other defects not related to mat
14. ic environment specified below Ensure the Heated Humidifier is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF radiated emissions Group 1 The Heated Humidifier system uses RF energy CISPR11 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 conducted emissions Class B The Heated Humidifier system is suitable for use E in all establishments and those directly connected to the public low voltage power Harmonic emissions Class A supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Electromagnetic immunity The Transcend Heated Humidifier is intended for use in the electromagnetic environment specified below Ensure the Heated Humidifier is used in such an environment Transcend Heated Humidifier Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 M IEC 60601 test level 2 4 6kV contact 8 kV air 2 kV for power Supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 gt 95 dip in Ur for 0 5 cycle 40 Ur 60
15. ice is fully seated in the Heated Humidifier Ensure that the water reservoir is properly attached to the humidifier body The reservoir has guides that will help to secure it in place Check the water supply inside of the water reservoir If the water is low then the red LED will illuminate to signal a refill Empty some water from the Water Reservoir Adjust the setting to a lower setting Adjust the setting to a higher setting If the problem persists contact your home medical equipment provider or Somnetics customer service at 1 877 621 9626 Adjust the setting to a lower setting Ensure that the reservoir cover is fully attached to the reservoir base Refer to reassembling the water reservoir section Inspect the Water reservoir for damage or cracks If there are signs of damage contact your home medical equipment provider or Somnetics customer service at 1 877 621 M Page 17 Transcend Heated Humidifier User Manual Problem Probable Cause Solution 9626 to order replacement All three LEDs at the Humidifier is in Unplug the Humidifier power supply back of the Humidifier a fault state are flashing Wait for 10 seconds Reattach the power supply to the Humidifier If the problem continues contact your home medical equipment provider or Somnetics customer service at 1 877 621 9626 Electromagnetic emissions The Transcend Heated Humidifier is intended for use in the electromagnet
16. ion in the air tubing Ending therapy 1 To stop therapy at any time press the power button the Transcend PAP device Image 9 Note It may take up to 60 seconds for the middle green LED to turn off M Page 11 Transcend Heated Humidifier User Manual Cleaning and maintenance 1 Unplug the Humidifier from the wall outlet and allow it to cool to the touch 2 Remove the PAP device by pulling it backward sliding it out of the guide slots of the Humidifier Image 10 a Periodic Cleaning Clean the exterior of the Humidifier as needed Use a mix of 5 mild liquid detergent in distilled water 1 6 fl oz liquid detergent per quart of distilled water This will clean away surface residue e Submerge a lint free cotton cloth into the detergent solution e Wipe the exterior of the Humidifier using a gentle back and forth wiping motion from the front to back of the device e Rinse the cloth in clear water to remove residual cleaning solution e Wring excess water from the cloth then wipe the Humidifier using a gentle front to back wiping motion to remove any detergent solution remaining on its surface e Wipe the device with a dry lint free cotton cloth until the device is fully dry b Daily Cleaning Follow the instructions below to clean the Water Reservoir e Remove Water Reservoir from the Humidifier Body and open the Fill Cap Image 11 e Fill the Reservoir to the maximum water mark wit
17. ms 10 KHz to 100 MHz 10 V m compliance level adjusted to meet FDA limits 26 MHz to 2 5 GHz Note At 80 MHz and 800 MHz the higher frequency range applies Transcend Heated Humidifier M User Manual Electromagnetic environment guidance Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment Recommended separation distance d 1 17 VP Recommended separation distance d 0 35 P 80 MHz to 800MHz Recommended separation distance d 0 70 P 800MHz to 2 5 GHz 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 Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol M Transcend Heated Humidifier User Manual Page 20 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
18. nd replacing the Water Reservoir Warning After use take care when removing the Water Reservoir from the Humidifier as the water and the Water Reservoir may be hot Warning Do not overfill the reservoir Overfilling may allow water to enter the air supply tubing Do not fill the reservoir above the indicated maximum fill level Warning Re insert the Water Reservoir slowly as water may spill into the air supply tubing if the Water Reservoir is not handled carefully Powering the Humidifier The Humidifier is supplied with a power E that connects to a wall outlet This power source is for the Humidifier only The PAP device must be powered separately using any of the available Transcend power options described in the PAP device User Manual To power the Humidifier plug the power supply cord into the back of the device then connect the power supply to a wall main power outlet Image 4 Note When looking at the back of the device the leftmost LED will turn solid green indicating that the Humidifier has power Note The Humidifier may only be powered by the AC power supply Caution Do not use a power converter or voltage transformer with Transcend products as it may damage them Do not use a modified sine wave power inverter to power the humidifier Caution Transcend automatically converts voltage but may require a plug adaptor for use in another country It is recommended you use the interchangeable plug adapto
19. rs supplied with the Transcend power supply Use only the Somnetics supplied Universal Power Supplies and accessories M Page 9 Transcend Heated Humidifier User Manual Starting therapy 1 Connect one end of the air supply tubing onto the air outlet of the Humidifier Connect the other end of the tubing to your user interface Image 5 Note Standard 6 foot air tubing is supplied with the Transcend PAP device If you have been using the PAP device without the Humidifier the universal hose adaptor must be removed from the 6 foot air tubing prior to use Air tubing is not included with the Humidifier 2 Place the PAP device into the corresponding slots located at the top of the Humidifier then slide the device forward until the nose cone is inside the humidifier body Image 6 Note The Transcend PAP device has arm bars which help to guide it into the Humidifier port 3 Power the Transcend PAP device as described in the corresponding User Manual The PAP device may be powered via wall main power Transcend battery or Transcend Mobile Power Adaptor as appropriate Nose Cone Note Be sure that the user interface is fit firmly in place before initiating therapy 4 Initiate therapy by pressing the power button on the PAP device Air flow from the PAP device will turn on the Humidifier automatically and it will begin warming the Water Reservoir The middle LED on the back of the humidifier will turn solid
20. umidifier Please follow the sections below to set up use and clean your Humidifier Setting up your Humidifier Place the Humidifier on a firm level surface near your bed It is recommended that the Humidifier not be placed on a surface that could be damaged by water Place the Humidifier at a level that is lower than your sleeping position Caution Do not position the Humidifier where it may be stepped on or accidentally overturned Filing the Water Reservoir 1 Remove the Water Reservoir by pulling it forward and out of the Humidifier Body Image 1 2 Pull up on the Fill Cap to open the Water Reservoir Image 2 3 Carefully fill the Water Reservoir with distilled water to the MAX fill line Image 3 4 Replace the Fill Cap ensuring it is tightly sealed Note When carrying a filled Water Reservoir ensure that the Fill Cap is sealed and the air outlet is tilted slightly upward Take precaution not to tilt the air outlet at a downward angle as water may spill out of the reservoir 5 Carefully re insert the Water Reservoir into the Humidifier Body Transcend Heated Humidifier User Manual Page 8 Note The base of the Humidifier Body has guides to help position the Humidifier Reservoir during reinsertion Caution If the Water Reservoir is not fully inserted the heater will not activate and the rightmost LED will turn red Warning Disconnect power from the Humidifier prior to removing filling a
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