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Related Manuals for Somnetics Transcend Sleep Apnea Therapy
Summary of Contents for Somnetics Transcend Sleep Apnea Therapy
- Page 1 Sleep Apnea Therapy System User Manual...
- Page 2 ® ® Trademark Somnetics and Transcend are registered trademarks of Somnetics International, Inc.; all rights reserved. Copyright © Copyright 2013 Somnetics International, Inc.; all rights reserved. Contact Somnetics International, Inc. Corporate headquarters Somnetics International, Inc. Email info@somnetics.com http://www.mytranscend.com/ Telephone 651.621.1800 Toll-free telephone 877.621.9626...
- Page 3 Page iii Transcend Sleep Apnea Therapy User Manual About this user manual This user manual is designed to be duplex-printed (printed on both sides of each Note sheet). If not printed in this manner, you will find blank pages in your printout.
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Page 4: Table Of Contents
Page iv Transcend Sleep Apnea Therapy User Manual Contents Introduction ....................7 Indications for use ....................7 Contraindications ....................7 Precautions for use ....................7 Warnings ....................... 8 Cautions ......................9 Symbols ......................10 Components of the Transcend System ............11 What’s not included (all sold separately) ............ - Page 5 Page v Transcend Sleep Apnea Therapy User Manual Alert codes ....................... 33 Filter Media change reminder………………………………………….……………………………………………………………………………..33 Troubleshooting ..................34 Appendix: Part numbers ................34 Disposable parts ....................35 Accessories ...................... 35 Replacement parts .................... 35 Appendix: Specifications ................37 Transcend ....................... 37 AC power supply PSA2 ..................
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Page 7: Introduction
USB port are also incorporated into Transcend. Indications for use The Transcend Sleep Apnea Therapy System provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use. -
Page 8: Warnings
• The device should be used only with masks and connectors recommended by Somnetics or a health care professional. A mask should not be used unless the device is turned on and is properly delivering ramp or therapy pressure. The exhalation port(s) associated with the mask should never be blocked. -
Page 9: Cautions
Inspect the power cord for signs of wear or damage before each use. Replace the power cord if necessary. • Somnetics recommends replacing the air delivery tubing (hose) after every three months of use. • To protect the environment, some parts and accessories of the Transcend System, including optional batteries, must be disposed of in accordance with local regulations. -
Page 10: Symbols
Page 10 Transcend Sleep Apnea Therapy User Manual Symbols Attention: Consult accompanying documents Type BF Applied Part ETL Classified ETL Seal of Approval demonstrating quality, safety and professional manufacturing of medical product Upper and lower temperature limits Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC. –... -
Page 11: Components Of The Transcend System
Page 11 Transcend Sleep Apnea Therapy User Manual Components of the Transcend System Begin by unpacking all items from the Transcend travel bag and inspect them to ensure they were not damaged during shipment. Report any missing or damaged items to the home healthcare provider that provided the Transcend System to you. -
Page 12: What's Not Included (All Sold Separately)
Page 12 Transcend Sleep Apnea Therapy User Manual What’s not included (all sold separately) • B Waterless Humidification System • M Waterless Humidification System • Nasal seal (mask cushion for use with H B or H M Waterless Humidification Systems) •... -
Page 13: Description Of Transcend System Components
Page 13 Transcend Sleep Apnea Therapy User Manual Description of Transcend System components Transcend Device Transcend comes ready to generate and regulate continuous positive airway pressure therapy for delivery to the interface. An external power source connects to the Transcend to supply power to the device. -
Page 14: Power Connection Jack And Usb Port
Page 14 Transcend Sleep Apnea Therapy User Manual Power connection jack and USB port The power jack accepts the barrel plug of the output cable from a DC power source to operate the Transcend. A variety of power sources may be used to power the Transcend. -
Page 15: Air Inlet Filter
Page 15 Transcend Sleep Apnea Therapy User Manual Air Inlet Filter During therapy operation ambient air is drawn into the Transcend through an Filter Media. The Filter Media should be cleaned at least weekly according to the instructions provided in this User Manual and replaced minimally after 6 months of use. -
Page 16: Assembling The Transcend System
Page 16 Transcend Sleep Apnea Therapy User Manual Assembling the Transcend System The mask interface connects to Transcend via the air supply tube. One end of the air supply tube attaches to the outlet port of Transcend via the Universal Hose Adaptor. The opposite end of the tube attaches to a mating fitting on the interface. -
Page 17: Powering The Transcend
Page 17 Transcend Sleep Apnea Therapy User Manual Powering the Transcend There are three choices for powering your Transcend device: • Using the Multi-plug Universal Power Supply (PSA2) • Using the optional Transcend P or P Battery • Using the optional Transcend Mobile Power Adapter (MPA1) -
Page 18: Using The Multi-Plug Universal Power Supply
LED flash sequence is complete the LED lights will turn off. This sequence indicates that power is being supplied to the Transcend and that it has successfully entered Standby Mode. Use only the Somnetics-supplied Universal Power Supplies. Do not use a power Note converter or voltage transformer with the PSA2 Universal Power Supply. -
Page 19: Using The Transcend P Or P Battery
Page 19 Transcend Sleep Apnea Therapy User Manual Using the Transcend P or P Battery The Transcend P and P Batteries are optional power sources for Transcend. To use, connect the P or P battery outlet cable to the Transcend by inserting the barrel connector into the power jack on the Transcend. -
Page 20: Using The Transcend P Using The Transcend P
Page 20 Transcend Sleep Apnea Therapy User Manual Using the Transcend P or P Battery in conjunction with the Transcend Mobile Power Adaptor Use the battery in-line with the Mobile Power Adaptor when possible. Connecting Note the battery in-line with the Mobile Power Adaptor allows the battery to charge during therapy and provides backup power to provide uninterrupted therapy in the case of a power outage. - Page 21 Charge the battery fully before the first use. Do not connect the Battery to Note Transcend during the initial charge. To maintain maximum battery performance Somnetics recommends using the Note Battery in-line with the AC Power Supply or Mobile Power Adaptor during therapy even if the battery is fully charged.
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Page 22: Using The Optional Chest Or Arm Strap With A Transcend P Or P Battery
Page 22 Transcend Sleep Apnea Therapy User Manual Using the optional chest or arm strap with a Transcend P or P Battery Slide battery into the battery pouch and attach the Velcro strap to secure. Insert the buckle through the loop of the battery pouch with the Velcro facing towards the battery pouch. -
Page 23: Using The Transcend Mobile Power Adaptor (Mpa1)
Adaptor is supplied with two cables: one to connect the MPA1 to the Transcend device, and the other to connect the MPA1 to a mobile power receptacle Use only the Somnetics-supplied Transcend Mobile Power Adaptor. Note Connect both cables to the base of the Mobile Power Adaptor. -
Page 24: Using The Transcend
Page 24 Transcend Sleep Apnea Therapy User Manual Using the Transcend The control panel of the Transcend has two pushbuttons that activate the blower and initiate the pressure ramp feature. There are also two LED lights, including a green LED for indicating normal operational modes and a yellow LED for indicating fault conditions. -
Page 25: Starting Therapy
Page 25 Transcend Sleep Apnea Therapy User Manual Starting therapy The Transcend control panel has two pushbuttons to activate the blower and the pressure ramp feature. There are also two LED lights, including a green LED for indicating normal operational modes and a yellow LED that indicates fault conditions. -
Page 26: Ending Therapy
Page 26 Transcend Sleep Apnea Therapy User Manual Ending therapy To end the delivery of therapy while the blower is on, press the Power button to deactivate the blower and return the device to Standby Mode. It is recommended the user initiate the Drying Mode function after each therapy session to dry the device interior. -
Page 27: Replacing The Filter Media
Page 27 Transcend Sleep Apnea Therapy User Manual Replacing the Filter Media The Transcend Filter Media should be replaced every six months at minimum. Remove the Filter Frame by gently pressing the button release at the back of the Filter Frame towards the front of the device. Then pull the filter frame away from the device. -
Page 28: Caring For Your Transcend And Components
Page 28 Transcend Sleep Apnea Therapy User Manual Caring for your Transcend and components This section presents the following topics: • Cleaning the exterior • Cleaning of accessories • Cleaning the filter media and filter frame Warning: • Unplug the Transcend before cleaning. -
Page 29: Cleaning Of Accessories
Page 29 Transcend Sleep Apnea Therapy User Manual Cleaning of Accessories The following accessories should be cleaned with a 5% solution of mild liquid detergent in distilled water (1.6 fl oz liquid cleaning detergent per quart of distilled water). Mild detergent should contain biodegradable anionic surfactants and no phosphate. -
Page 30: Cleaning The Filter Media And Filter Frame
Page 30 Transcend Sleep Apnea Therapy User Manual 3. Clean the inside of the air supply tube by lifting, then lowering the ends of the tube while the tube is filled with cleaning solution. 4. Rinse accessories by immersing in distilled water. Move the accessory in a back and forth motion for approximately10 seconds to remove cleaning agent residue. - Page 31 Page 31 Transcend Sleep Apnea Therapy User Manual 10. Wring excess water from the cloth then wipe all surfaces of the Filter Media to remove any cleaning solution remaining on its surface. 11. Dry surfaces by wiping with a dry, lint-free cotton cloth.
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Page 32: Fault, Alert And Reminder Codes
Page 32 Transcend Sleep Apnea Therapy User Manual Fault, alert and reminder codes Fault codes When Transcend encounters a fault the processor resets and enters a fault loop. In this loop, the device repeatedly flashes the yellow fault LED to indicate the specific fault encountered. -
Page 33: Alert Codes
Page 33 Transcend Sleep Apnea Therapy User Manual Alert codes Alerts are similar to faults but they do not reset the processor when they occur (i.e., the device continues to deliver therapy pressure). Device LED Fault Error Comments Flashes Cannot regulate... -
Page 34: Troubleshooting
Page 34 Transcend Sleep Apnea Therapy User Manual Troubleshooting Problem Probable Cause Solution Discomfort due to a feeling Transcend device pressure may Breathe slowly through your nose with of high pressure. be set too high. your mouth closed. Use the ramp pressure, if available. -
Page 35: Appendix: Part Numbers
Page 35 Transcend Sleep Apnea Therapy User Manual Appendix: Part numbers This section presents three topics: • Disposable parts • Accessories • Replacement parts Disposable parts Item Part Item Part number number Air Inlet Filter (earlier generation) 503003 Base Pad (optional) -
Page 36: Appendix: Specifications
Page 36 Transcend Sleep Apnea Therapy User Manual Appendix: Specifications This section presents the following topics: • Transcend • AC power supply - PSA2 • Mobile power adaptor (optional) - MPA1 • Batteries • Transcend performance • Manufacturer’s declaration Transcend Transcend weight: Less than 1.0 lbs (454 gm) - Page 37 Page 37 Transcend Sleep Apnea Therapy User Manual Transcend performance Working pressure range: 4 to 20 cm H Accuracy of pressure setting: ±1 cm H O or ±10%, whichever is greater Maximum system shutdown pressure: 30 cm H Ramp time duration:...
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Page 38: Manufacturer's Declaration
Page 38 Transcend Sleep Apnea Therapy User Manual Manufacturer’s declaration This section presents the following topics: • Electromagnetic emissions • Electromagnetic immunity • IEC 60601-1 Compliance Electromagnetic emissions The Transcend system is intended for use in the electromagnetic environment specified below. - Page 39 Page 39 Transcend Sleep Apnea Therapy User Manual Immunity test IEC 60601 test Compliance level Electromagnetic level environment—guidance Surge ±1 kV differential ±0.5*, 1 kV differential Line power quality should be mode mode that of a typical commercial or IEC 61000-4-5 hospital environment.
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Page 40: Iec 60601-1 Compliance
Page 40 Transcend Sleep Apnea Therapy User Manual IEC 60601-1 compliance Protection against electric shock: Class II Type BF Degree of protection against ingress of IP22 water: Equipment not suitable for use in the presence of a flammable Use of flammable gasses: anesthetic mixture with air or oxygen, or with nitrous oxide. - Page 41 Page 41 Transcend Sleep Apnea Therapy User Manual Maximum flow rate Test Pressures (typical) 4 cm 8 cm 12 cm 16 cm 20 cm Measured pressure at the patient connection port (hPa) 11.0 15.0 19.0 Average flow at the patient...
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Page 42: Appendix: Limited Warranty
Page 42 Transcend Sleep Apnea Therapy User Manual Appendix: Limited 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:... - Page 43 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 Sleep Apnea Therapy System User Manual 103084 Rev M...
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