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Related Manuals for Somnetics Transcend
Summary of Contents for Somnetics Transcend
- Page 1 ® Sleep Apnea Therapy User Manual...
- Page 2 ® ® Trademark Somnetics and Transcend are registered trademarks of Somnetics International, Inc.; all rights reserved. Copyright © Copyright 2012 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 IEC 60950-1 safety standards. • Do not plug any devices into the Transcend USB port other than a computer that is compliant with 60950- 1 safety standards. Attaching any other device to the Transcend USB port may damage Transcend and may not be safe for the user.
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Page 4: Table Of Contents
Contraindications ..............................1 Precautions for use...............................2 Warnings ...............................2 Cautions.................................3 Symbols ................................4 Components of the Transcend Sleep Apnea Therapy System ......5 Transcend Sleep Apnea Therapy System Starter Package...................6 Transcend H B Waterless Humidification System ....................7 Transcend H M Waterless Humidification System .....................8 What’s not included (all sold separately)......................9... - Page 5 Replacing disposable parts................36 Replacing the base pad............................36 Replacing the forehead pad..........................36 Replacing the air inlet filter ..........................37 Replacing the HME............................38 Caring for your Transcend and components..........39 Cleaning the interior with drying mode ......................39 Cleaning the exterior............................39 Cleaning components............................40 Cleaning components ..........................41 Cleaning the air inlet filter ..........................41...
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Page 7: Introduction
Short breathing tube Indications for use The Transcend Sleep Apnea Therapy System is intended for the therapy of adults over 66 pounds (30 kg) with obstructive sleep apnea (OSA). The device delivers continuous positive airway pressure (CPAP), which prevents the collapse of the upper airway, thereby preventing obstructions that can interfere with spontaneous breathing. -
Page 8: Precautions For Use
• This device is not intended for life support. • The Transcend Sleep Apnea Therapy System must be set up and adjusted by a trained CPAP provider before being used for therapy ramp and pressure. • The air temperature produced by this device can be as much as 10ºF higher than the temperature of the room. -
Page 9: Cautions
Page 3 • The device should be used only with masks and connectors recommended by Somnetics or with those recommended by the health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked. -
Page 10: Symbols
Page 4 Sleep Apnea Therapy User Manual Symbols Attention: consult accompanying documents Type BF Applied Part 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. – Waste Electrical and Electronic Equipment (WEEE) Consult instructions for use Upper and lower humidity limits... -
Page 11: Components Of The Transcend Sleep Apnea Therapy System
Components of the Transcend Sleep Apnea Therapy System When you receive the Transcend Sleep Apnea Therapy System package, unpack all items from the 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 CPAP device to you. -
Page 12: Transcend Sleep Apnea Therapy System Starter Package
Transcend Sleep Apnea Therapy System Starter Package • • Transcend CPAP Travel bag • • Standard 6-foot hose- not HME compatible CD, DVD • • Universal hose adaptor Quick start guide • Universal AC power supply Components of the Transcend Sleep Apnea Therapy System... -
Page 13: Transcend H
Transcend H B Waterless Humidification System • • Mask shell assembly Headgear • • Adjustable arm bars (S,M,L) Transcend H B hose • • Forehead pad & holder 4 HMEs • Adaptor ring Components of the Transcend Sleep Apnea Therapy System... -
Page 14: Transcend H
Transcend H M Waterless Humidification System • • Mask shell assembly Headgear • • Adjustable arm bars (S,M,L) Transcend H M hose • • Forehead pad and holder 4 HMEs • Adaptor ring Components of the Transcend Sleep Apnea Therapy System... -
Page 15: What's Not Included (All Sold Separately)
What’s not included (all sold separately) • A nasal seal • Transcend mobile power adaptor • Transcend P Overnight Battery System • Transcend P Multi-night Battery System • Docking station • USB cord Components of the Transcend Sleep Apnea Therapy System... -
Page 16: Description Of Cpap System Components
This section presents the following topics:: • CPAP device • Interface for Transcend H6B and H9M Waterless Humidification Systems • Headgear for Transcend H6B and H9M Waterless Humidification Systems CPAP device The CPAP device contains all of the electromechanical hardware necessary to generate and regulate CPAP therapy for delivery to the interface. -
Page 17: Power Jack And Usb Port
Sleep Apnea Therapy User Manual Page 11 Power jack and USB port The power jack accepts the barrel plug of the output cable from a DC power source to operate the CPAP. The range of DC input voltage acceptable to the CPAP is 14VDC to 19VDC. -
Page 18: Data Card Receptacle And Air Inlet Filter
CPAP through an inlet filter. This filter is washable and should be washed with mild dishwashing detergent and dried at least monthly. Air inlet filter Interface for Transcend H B and H Waterless Humidification Systems The interface connects the therapy pressure delivered by the CPAP device to the patient. -
Page 19: Headgear For Transcend H
B Humidification System headgear The Transcend H B humidification system headgear holds the Transcend interface and H B hose in place with a set of straps and ball clips. The interface headgear should be adjusted so that the forehead pad rests just above the brow line and the mask fits snugly against the face. -
Page 20: Assembling The Transcend Cpap System
It is important that the pressure sensor line is connected properly to the pressure sensor ports on the CPAP and the interface. The procedures for connecting the Transcend CPAP system depend on which package you purchase. This section presents the following topics: •... -
Page 21: Assembling The Transcend H
Page 15 Assembling the Transcend H B Waterless Humidification System Follow these steps to assemble the Transcend H B waterless humidification system: Attach the adaptor ring to the mask shell. Connect the top clip first; then connect the bottom clips. Both must click firmly into place. - Page 22 Connect top headgear strap through the slot on the side of the headgear. Insert the heat moisture exchanger (HME) in Replacing the to the HME cartridge, refer to HME, page 38. Assembling the Transcend CPAP System...
- Page 23 Connect the Transcend H B hose to the mask shell. Secure the Transcend H B hose to the headgear using the fold over hook and loop strap. Connect the Transcend H B hose to the CPAP. Assembling the Transcend CPAP System...
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Page 24: Assembling The Transcend H
Sleep Apnea Therapy User Manual Assembling the Transcend H M Waterless Humidification System Follow these steps to assemble the Transcend H M Waterless Humidification System: Attach the adaptor ring to the mask shell. Connect the top clip first; then connect the bottom clips. - Page 25 Attach the headgear to the CPAP as shown. Attach the interface to the remaining headgear straps and place the forehead pad on the forehead piece. Insert the heat moisture exchanger (HME) into the HME cartridge, refer to Replacing the HME, page 38. Assembling the Transcend CPAP System...
- Page 26 Page 20 Sleep Apnea Therapy User Manual Connect the Transcend H M hose to the mask shell. Connect the Transcend H M hose to the CPAP. Assembling the Transcend CPAP System...
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Page 27: Fitting The Transcend H
Select another size arm bar and attach to the slide adjustment and forehead piece. Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems... - Page 28 Connect the headgear to the interface by inserting the ball clips into the notches on mask shell. Adjust the headgear straps until the interface feels secure. Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems...
- Page 29 B hose to the interface then attach the hose to the headgear with the fold over hook and loop strap. Attach the other end of the hose to the CPAP. Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems...
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Page 30: M Waterless Humidification System
, place Transcend on the head so that the rear head band fits at the nape of the neck. Fit the mask so the forehead pad rests just above the brow line. Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems... - Page 31 Gently squeeze the sides of the arm bar to slide the mask further from or closer to the face, so that it fits comfortably against the nose. Adjust the headgear straps until the interface feels secure. Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems...
- Page 32 The interface should feel secure while lying down, but the CPAP will shift slightly with movement of the head. Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems...
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Page 33: Powering The Cpap
(page 32) Using the universal AC power supply The Transcend Sleep Apnea Therapy System includes a universal AC power supply adaptor. It provides 19VDC for powering the CPAP device. A detachable power cord connects to the AC line (100-240VAC, 50/60Hz). -
Page 34: Using The Transcend P
To charge the battery without the CPAP device attached, connect the power supply to the battery. Insert the barrel plug from the universal AC power supply into the battery. Insert the barrel plug of the battery into the Transcend ™ power jack so that the plug and cord face upward. -
Page 35: Multi-Night Battery System With The Mobile Power Adaptor
Insert the barrel plug from the mobile power adaptor into the battery. Insert the barrel plug of the battery into the Transcend power jack so that the plug and cord face upward. Insert the second mobile power adaptor cable into the mobile power receptacle. -
Page 36: Overnight Battery System Or P
The battery will show a yellow or green LED light when it is used with an additional power source (AC power supply or mobile power adaptor) to power Transcend. Note The battery will show no LED light when it is used as the sole power source to power Transcend. Charging the Transcend P Overnight Battery System or P... - Page 37 Sleep Apnea Therapy User Manual Page 31 Using the chest or arm strap with a Transcend P Overnight Battery System or P Multi-night Battery System Insert the buckle through the strap loop of the battery pouch with the Velcro facing the battery.
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Page 38: Using The Mobile Power Adaptor
Using the mobile power adaptor The Transcend Sleep Apnea Therapy System may be powered with an optional 12VDC mobile power adaptor. The mobile power adaptor is supplied with two cables: one to connect to your CPAP, and the other to connect to a mobile power receptacle (e.g. -
Page 39: Using The Cpap
Sleep Apnea Therapy User Manual Page 33 Using the CPAP The control panel of the CPAP has two pushbuttons (one activates the blower and the other initiates the pressure ramp feature) and two LEDs (a green LED for indicating normal operational modes and a yellow LED for indicating fault conditions). -
Page 40: Starting Therapy
Power button Yellow LED Ensure that Transcend is completely connected to a power source and is in standby mode (when power is initially applied to the device, it enters Standby mode after a brief LED power-up flash sequence). Press the power button to turn Transcend on. Air flow will begin as the blower delivers your prescribed pressure. -
Page 41: Ending Therapy
If the blower is off while the power is applied, the device is in standby mode. It is recommended that you initiate drying mode function to clean the Transcend interior after completing each therapy session. Drying mode... -
Page 42: Replacing Disposable Parts
Page 36 Sleep Apnea Therapy User Manual Replacing disposable parts This section presents the following topics about replacing disposable parts: • Replacing the base pad • Replacing the forehead pad • Replacing the air inlet filter • Replacing the HME Replacing the base pad Replace the base pad (part number 503009) as needed. -
Page 43: Replacing The Air Inlet Filter
Page 37 Replacing the air inlet filter Transcend’s air inlet filter should be replaced every six months. Remove the pad from the bottom of the CPAP. Remove the filter plate by gently squeezing the tab at the back of the plate towards the front of the CPAP and pulling the plate away from the CPAP. -
Page 44: Replacing The Hme
Page 38 Sleep Apnea Therapy User Manual Replacing the HME The HME should be changed weekly. Disconnect the air supply tube from the mask shell by grasping the HME cartridge and release the lateral clips. To remove HME, pull out of the HME cartridge. -
Page 45: Caring For Your Transcend And Components
Cleaning the interior with drying mode Drying mode should be used daily to clean the Transcend interior. Set Transcend on a dry and stable surface (cloth surface is not recommended as it may get soiled). Do not wear Transcend while it is in drying mode. -
Page 46: Cleaning Components
Cleaning components The headgear, interface, device and forehead pads should be washed weekly. The tubing should be washed daily. This section presents the following topics: • Cleaning components • Cleaning the air inlet filter Caring for your Transcend and components... -
Page 47: Cleaning Components
Do not use harsh or abrasive cleaning agents to clean any CPAP components. • Do not sterilize the CPAP device. • Do not place cleaning materials, such as a cloth or liquid, into the CPAP air inlet or air outlet connector. Caring for your Transcend and components... -
Page 48: Fault, Alert And Reminder Codes
Page 42 Sleep Apnea Therapy User Manual Fault, alert and reminder codes This section describes four types of fault, alert and reminder codes: • Non-smartcard fault codes • Smartcard fault codes • Alert • Filter change reminder Non-smartcard fault codes When the CPAP encounters a non-smartcard fault, the processor resets and enters a fault loop. -
Page 49: Smartcard Fault Codes
Sleep Apnea Therapy User Manual Page 43 Device LED Fault LED Error Comments Flashes Blower over-temp The blower thermistor has reported an excessive temperature. 14 times* If this fault occurs, check all tubes and hoses to ensure that they are properly connected. If the fault occured during therapy, make sure the mask is properly fitted and not leaking. -
Page 50: Troubleshooting
Page 44 Sleep Apnea Therapy User Manual Troubleshooting Problem Probable Cause Solution Discomfort due to a feeling of CPAP device pressure may be set Breathe slowly through your nose with your high pressure. too high. mouth closed. Use the ramp pressure, if available. If the pressure remains problematic, contact your homecare provider. -
Page 51: Appendix: Part Numbers
Mobile power adaptor-MPA1 503029 Chest Strap 503024 Arm Strap 503027 Replacement parts Item Part number Item Part number Transcend Sleep Apnea Therapy 503042 Interface shell 503034 Starter System Transcend H B Waterless 303005 Transcend H B Hose 503039 Humidification System... -
Page 52: Appendix: Specifications
13.5 VDC nominal. 12 to 15.5 VDC Batteries Multi-night Battery System 14.4 VDC, 5,200 mAH (for therapy pressures of 4 to 18 cm H Transcend P Overnight Battery System 14.4 VDC, 2,600 mAH (for therapy pressures of 4 to 14 cm H Appendix: Specifications... -
Page 53: Cpap Performance
Sleep Apnea Therapy User Manual Page 47 CPAP 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: 0-45 min + 25% time variance Operating temperature range: 41 to 104°F (5 to 40°C) -
Page 54: Manufacturer's Declaration
Page 48 Sleep Apnea Therapy User Manual Manufacturer’s declaration This section presents the following topics: • Electromagnetic emissions (page 48) • Electromagnetic immunity (page 48) • EN 60601-1 compliance (page 50) Electromagnetic emissions The CPAP system is intended for use in the electromagnetic environment specified below. The customer or the user of the CPAP system should ensure that it is used in such an environment. - Page 55 Sleep Apnea Therapy User Manual Page 49 Immunity test IEC 60601 test level Compliance level Electromagnetic environment— guidance Voltage dips, short <5% U (>95% dip in <5% U (>95% dip in U ) for Linepower quality should be that of a interruptions, and voltage ) for 0.5 cycle 0.5 cycle...
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Page 56: En 60601-1 Compliance
Page 50 Sleep Apnea Therapy User Manual EN 60601-1 compliance Protection against electric shock: Class II Type BF Degree of protection against ingress of water: IPX0 Use of flammable gasses: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen, or with nitrous oxide. - Page 57 Sleep Apnea Therapy User Manual Page 51 Maximum flow rate (typical) Test Pressures 4 cm H 8 cm H 12 cm H 16 cm H 20 cm H Measured pressure at the patient connection port (hPa) 11.0 15.0 19.0 Average flow at the patient connection port (l/min)
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Page 58: Appendix: Limited Warranty
2 years from the date of sales by Somnetics to the dealer. The battery packs are similarly warranted for a period of 9 months from the date of sale by Somnetics to the dealer. - Page 59 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 Sleep Apnea Therapy User Manual 103084 Rev F...
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