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Page 28

 

 

 

Electromagnetic Compatibility 

The Transcend Micro complies with all applicable electromagnetic compatibility 
requirements (EMC) according to IEC60601-1-2:2014 for residential, commercial and light 

industry environments. Portable and mobile RF communications equipment should be 
used no closer to any part of the device, including cables, than the recommended distance 

of separation (30CM). The Transcend Micro has been designed to meet EMC standards, 

however should you suspect the device performance is being affected by other equipment, 
move the device away from the potential cause of the interference. The Transcend Micro 

complies with Part 15 of the FCC rules and Industry Canada license-exempt RSS 
standards. Operation is subject to the following two conditions 1) this device may not 

cause harmful interference, and 2) this device must accept any interference received, 

including interference that may cause undesired operation. 
 

Electromagnetic Emissions 

The Transcend Micro is intended for use in the electromagnetic environment specified 

below. The customer or the user of the system should ensure that it is used in such an 
environment. 

 

Emissions test 

Compliance 

Electromagnetic environment

—

guidance 

RF radiated 

emissions 
CISPR 11 

Group 1 

The Transcend Micro uses RF energy only for its 

internal function. Therefore, its RF emissions are 
very low and are not likely to cause any 

interference in nearby electronic equipment. 

RF conducted 

emissions 
CISPR 11 

Class B 

The Transcend Micro 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. 

Harmonic 

distortion 
IEC 61000-3-2 

Class A 

Voltage 
fluctuations/

flicker emissions 
IEC 61000-3-3 

Complies 

 

Содержание Micro

Страница 1: ...Micro User Manual ...

Страница 2: ...tton and LED indicators 11 Using MySleepDash app 12 Connecting your smart device to the app 12 Connecting your Transcend Micro to the app 12 Starting Stopping Therapy 13 Using the Ramp Function 13 Using the EZEX Function 14 Ending Therapy 14 Drying Mode 14 Caring for your Device 14 Disconnecting Comfort Features 15 WhisperSoft muffler assembly 15 AirMist HME adapter assembly 15 Cleaning the Exteri...

Страница 3: ...ce data 27 Electromagnetic Compatibility 28 Electromagnetic Emissions 28 Electromagnetic Immunity 29 IEC 60601 1 Third Edition Classification 31 Performance 31 Pressure 31 Sound 32 Appendix 33 Part Numbers Disposables 33 Part Numbers Accessories 33 Part Numbers Replacements 33 Limited Warranty 34 Notices 36 Contact Transcend Inc 36 ...

Страница 4: ...thologically low blood pressure particularly if associated with intravascular volume depletion Pneumothorax or pneumomediastinum Pneumocephalus has been reported in some users using nasal PAP Caution should be used when prescribing PAP for susceptible users such as those with any of these conditions Cerebral spinal fluid CSF leaks Abnormalities of the cribriform plate A prior history of head traum...

Страница 5: ...m includes the following Transcend Micro Transcend Micro AirFlex 6 ft Hose Transcend Micro Quick Guide Transcend Travel Pouch Power supply 40W AC Transcend WhisperSoft Muffler Kit packaged separately Contact your CPAP supplier for a range of accessories available separately for use with the device including Transcend AirMist HME Kit Transcend PowerAway Battery Transcend Portable Solar Battery Char...

Страница 6: ...ooth button c Pressure ramp button d Dry cycle button e Air filter cover The Transcend Micro device uses a custom filter f Air outlet The Transcend Micro has a custom hose designed for the device g USB C data port h Power supply outlet b c d g h a f e ...

Страница 7: ...ntly insert at a slight angle and twist the air hose coupler clockwise until you feel it begin to insert Continue twisting until the air hose connector is seated securely into the device The image below indicates a fully secured hose with the hose arrow below the parting line of the device 4 Connect the mask to opposite end of the air hose NOTE The hose is the applied part and constitutes the air ...

Страница 8: ...AC adapter and a power outlet The battery will begin to charge automatically NOTE Do not connect the battery to the Transcend Micro during the initial charge 2 Once the battery is fully charged it is ready for use with the Transcend Micro It may take up to eight 8 hours to charge the PowerAway battery To use the Transcend PowerAway battery in conjunction with AC line power as a backup power supply...

Страница 9: ...ter assembly 1 Remove the HME cartridge from foil package Handle by the plastic shroud not the foam core 2 Unscrew the HME adapter bottom from the HME adapter top and place the HME cartridge inside the HME adapter bottom 3 Place the HME adapter top onto the HME adapter bottom and gently turn the top until the adapter compresses together on the HME cartridge 4 Securely attach the HME adapter bottom...

Страница 10: ... device will begin regulating to pressure Therapy Mode When the device is powered and in Therapy Mode The LED is off Pressing the power button transitions the device to Standby Mode o The LED glows green o The blower stops Bluetooth button and LED indicators Standby Mode Pressing the Bluetooth button toggles communication between enabled disabled Bluetooth indicator light is blue Bluetooth communi...

Страница 11: ...figured or Auto Ramp is disabled o If therapy is started when the ramp LED is off the device will begin at the starting therapy pressure Pressing the button when Ramp is not configured has no effect o See Transcend desktop software user guide to configure https mytranscend com customer care user guides Pressing the button when Ramp is configured toggles Auto Ramp between enabled and disabled Thera...

Страница 12: ...uetooth Open the MySleepDash app The first time you open the MySleepDash app you will be asked to login or create an account using your email You will be required to o Provide consent for the use of analytics o Accept Transcend s terms of use and privacy notice o Provide consent for the MySleepDash app to upload data to the cloud Additional information about terms and privacy policies are provided...

Страница 13: ... ramps to the prescribed therapy pressure NOTE Some masks are configured differently Due to this variability SleepStart may not function NOTE If therapy is interrupted by a power failure the device will automatically restart therapy once power is restored Using the Ramp Function The Ramp feature lets you acclimate to air flow by starting at a lower pressure and gradually increasing to the prescrib...

Страница 14: ... session it is recommended that the user initiate the Drying Mode function to dry the attached air hose and accessories To initiate Drying Mode Press the Drying Mode button When in Drying Mode the blower will run at a low speed for 30 minutes During Drying Mode the Drying Mode LED will continue to glow After 30 minutes the blower will turn off and the device will enter Standby Mode Caring for your...

Страница 15: ... following this Warning will not be covered by Transcend s limited warranty Disconnecting Comfort Features WhisperSoft muffler assembly 1 Remove the short air hose from the device by twisting the connector left or counterclockwise and pulling the hose away from the device Disconnect the other end of the hose from the muffler 2 Remove the muffler from one end of your long hose and your mask from th...

Страница 16: ...s using a gentle back and forth wiping motion Ensure contact with all accessible surfaces to adequately remove any soil buildup 4 Rinse the cloth in clear water to remove residual cleaning solution 5 Wring excess water from the cloth and wipe the Transcend Micro using a gentle front to back wiping motion to remove any detergent solution remaining on the surface 6 Wipe the device with a dry lint fr...

Страница 17: ...d forth motion for approximately 10 seconds to remove cleaning agent residue 5 Dry the outside of the accessory with a dry lint free cotton cloth Allow the accessory to air dry until the inside is dry Length of drying time will depend on ambient conditions Transcend batteries DO NOT immerse batteries in water or cleaning solution For long term storage which is any duration of time greater than thr...

Страница 18: ...anufacturer s instructions must be followed with regard to cleaning disinfecting and re use of patient interfaces masks Warning Only use bacterial viral filters that are commercially available and designed for use with CPAP machines Only use filters that are ISO 23328 1 2003 and ISO 23328 2 2002 approved Follow the manufacturer s instructions for use of the filter Only use those commercially avail...

Страница 19: ...nected to power disable Bluetooth enter airplane mode by pressing the Bluetooth button until the indicator light is white Do not use the MySleepDash app Use the Start Stop button on your machine to start therapy To reconnect Bluetooth after exiting the plane press the Bluetooth button and follow steps to connect to the app Troubleshooting Problem Possible Cause Solution Discomfort due to a feeling...

Страница 20: ...No airflow from the device Device motor failure or electronics failure Contact the homecare provider s technical service department All LEDs flash two times then pause then flash again Device detects an operating error Hold down the power button until all LEDs stops flashing Release the power button the device will reset and power up in Standby Mode Check hose mask and any accessories in the breat...

Страница 21: ...with the app phone function Verify app is downloaded and installed the phone supports Bluetooth Low Energy and has Bluetooth enabled SleepStart is not functioning Breathing circuit has excessive leaks Check hose mask and any accessories in the breathing circuit for air leaks and proper fit User not breathing deep enough to trigger SleepStart Ensure deep breath is taken with mask securely fitted or...

Страница 22: ...If the device is to be used by multiple patients a main flow bacteria filter should be installed in line between the device and the mask to prevent contamination Only use filters that are ISO 23328 1 2003 and ISO 23328 2 2002 approved The device should be used only with masks and connectors recommended by Transcend or a health care professional A mask should not be used unless the device is turned...

Страница 23: ...no closer than 30 cm 12 inches to any part of the Micro device Cautions Federal law in the US restricts this device to the sale by or on the order of a physician Power the Transcend Micro only with the Transcend supplied power supplies or batteries Discontinue use of the Transcend Micro and contact your physician if respiratory or skin irritations occur Do not introduce objects into the Transcend ...

Страница 24: ...tion where dust or pests insects can affect equipment safety and or performance o Do not position next to a curtain that blocks the flow of cooling air thereby causing the equipment to overheat o Do not block the air intake port thereby interfering with therapy ...

Страница 25: ... restricts this device to sale by or on the order of a physician or properly licensed practitioner Precedes reference or item number Batch code Date of Manufacture Manufacturer Fragile handle with care Keep dry Serial Number Bluetooth Regulatory Compliance Mark indicates compliance with Australian Radiocommunications Notice 2014 and Radiocommunications Act 1992 Wireless FCC part 15 compliant RTCA ...

Страница 26: ...end Micro Performance Working pressure range 4 to 20 cm H2O Accuracy of pressure setting 1 cm H2O or 10 whichever is greater Maximum system shutdown pressure 30 cm H2O Ramp time duration 0 45 min 25 time variance Operating temperature range 41 to 95 F 5 to 35 C Storage transport temperature range 4 to 140ºF 20 to 60ºC Operating humidity range 10 to 80 relative humidity non condensing Storage trans...

Страница 27: ...e license collectively Open Source Software Use of device data When you use this device it gathers and records data about your use and if your device connectivity is enabled the device sends certain data to Transcend via the cloud to enable Transcend to deliver various benefits to you and your care provider s Additionally some of that data may be used by Transcend 1 to comply with its legal obliga...

Страница 28: ...armful interference and 2 this device must accept any interference received including interference that may cause undesired operation Electromagnetic Emissions The Transcend Micro is intended for use in the electromagnetic environment specified below The customer or the user of the system should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment gui...

Страница 29: ...EC 61000 4 2 2 4 8 15kV air 8 kV contact Radiated RF EM fields IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Electrical fast transient burst IEC 61000 4 4 2 kV 100 kHz repetition frequency Surges Line to ground IEC 61000 4 5 1 0 5 kV 1kV Surges Line to ground IEC 61000 4 5 0 5 kV 1kV 2kV Voltage dips IEC 61000 4 11 0 5 cycle At 0 45 90 135 180 225 270 and 315 degrees 0 Ut 1 cycle and 70 Ut...

Страница 30: ... V 15 MHz 80 MHz 6V in ISM and amateur radio bands between 0 15 MHZ and 80 MHz 80 AM at 1kHz Test specifications for enclosure port immunity to RF wireless communications equipment Test frequency MHz Band MHz Service Modulation Maximum power Distance Immunity Test Level 385 380 390 TETRA 400 Pulse modulation 18Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5kHz deviation 1 kHz sine 2 0 3 28 710 704...

Страница 31: ...equal to 12 5 mm in diameter Vertically falling drops shall have no harmful effects Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or with nitrous oxide Performance Pressure Testing in accordance with ISO 80601 2 70 2020 for pressure accuracy and measurement uncertainty of manufacturer s test equipment Pressure type Accuracy Measurement uncertai...

Страница 32: ...atic 31 dBA with an uncertainty of 2 dBA Sound power level 10cm H20 pressure static 39 dBA with an uncertainty of 2 dBA Sound pressure level reported in a typical use environment Maximum flow rate typical Test Pressures 4 cm H2O 8 cm H2O 12 cm H2O 16 cm H2O 20 cm H2O Measured pressure at the patient connection port hPa 2 59 6 78 10 84 14 94 19 02 Average flow at the patient connection port l min 6...

Страница 33: ...PowerAway P8 Battery 503023 Transcend AirFlex Micro 4 505013 Transcend AirMist Humidification Kit 505009 Transcend Portable Solar Battery Charger 503056 Transcend WhisperSoft Micro 6 505029 Transcend WhisperSoft Micro 4 505028 Transcend SleepPak 505008 Part Numbers Replacements Item Part number Item Part number Transcend Micro 505000 Transcend Micro Power Supply PSA5 505010 Transcend Micro Filter ...

Страница 34: ...d instructions f lack of reasonable care or g other defects not related to material or workmanship This warranty is not transferable If Transcend finds that a product returned for service or the issue raised is not covered under this limited warranty Transcend may charge an evaluation fee and return shipping If a Product does not meet the warranty above Transcend will repair or replace the Product...

Страница 35: ...exclusions and limitations may not apply to you Warranty claims on a defective product must be made by the initial consumer at the point of purchase within 30 days after the discovery of the defect You may contact your authorized Transcend dealer or Transcend at 103 Osborne Road NE Fridley Minnesota 55432 USA 1 877 621 9626 or 1 651 621 1800 See also www MyTranscend com warranty to submit a claim ...

Страница 36: ...d Inc and Transcend are trademarks and or registered trademarks of Transcend Inc Copyright Copyright 2022 Transcend Inc all rights reserved Contact Transcend Inc Corporate headquarters Transcend Inc 103 Osborne Road NE Fridley Minnesota 55432 USA Email info Transcend com Web http www MyTranscend com Telephone 651 621 1800 Toll free telephone 877 621 9626 Fax 651 204 0064 Rx only 104149 REV A 2022 ...

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