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AlertIconTypeDescriptionPossible CauseAction
Automatic OffStatusDisplayed when 
therapy ends due to 
automatic off function.
The mask has been 
removed.
Put your mask back 
on, confirm good fit, 
and turn airflow on to 
resume therapy.
Inlet blocked. 
Check filter.
NotificationBlocked airwayBlockage at device 
inlet.
Check device air inlet 
is not obstructed.  
Check air filter(s) are 
installed properly and 
are clean; replace if 
needed.  
Low Leak: Check 
Mask and Tube
NotificationBlocked airwayBlockage at tube or 
mask.
Check tube is not 
crushed or folded 
such that air flow 
is restricted. Check 
mask is attached 
properly and without 
any obstruction.
Check Mask Fitn/aStatusDisplayed when 
Check Mask Fit 
function is enabled 
from Patient Menu.
n/aThis alert can be 
cleared by pressing 
the Control Dial. 
Otherwise it will time 
out after 60 seconds.
Loading Language 
and Rebooting
StatusDisplayed when a new 
language is selected 
from the menu.
n/aNo action needed.  
Times out when 
complete.
BusyStatusDisplayed when the 
device is temporarily 
inaccessible due to 
data communication.
n/aNo action needed.
“Sleep Progress”n/aStatusDisplays last 3 nights 
hourly use on first 
screen, and nights of 
use on second screen.
n/aPress Control Dial 
to acknowledge and 
clear each screen.  
Otherwise message 
times out after 30 
seconds.
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TroubleshootingYour device is equipped with a self-diagnostic tool call “Performance Check”. This tool can evaluate your device for certain errors. It also allows you to share key device settings with your Provider. Use Performance Check when directed by your provider.
The table below lists some of the problems you may experience with your \
device and possible solutions to those problems.
ProblemWhy It HappenedWhat To Do
Nothing happens when you apply power to the device. The backlights on the buttons do not light.
There’s no power at the outlet or the device is unplugged.
If you are using AC power, check the outlet and verify that the device is properly plugged in. Make sure there is power available at the outlet. Make sure the AC power cord is connected correctly to the power supply and the power supp\
ly 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, so they can determine if the problem is with the device or power supply.
If you are using DC power, make sure your DC power cord and battery adaptor cable connections are secure. Check your battery. It may need recharged or replaced. If the problem persists, check the DC cord’s fuse following the instructions supplied with your DC cord. The fuse may need to be replaced. If the problem still occurs, contact your home care provider. 
The airflow does not turn on.There may be a problem with the blower.
Make sure the device is powered correctly. Make sure the Home screen appears on the user interface. Press the Therapy button on top of the device to start airflow. If the airflow does not turn on, there may be a problem with your device. Contact your home care provider for assistance.
The device’s display is erratic.The device has been dropped or mishandled, or the device is in an area with high Electromagnetic Interference (EMI) emissions. 
Unplug the device. Reapply power to the device. If the problem continues, relocate the device to an area with lower EMI emissions (away from electronic equipment such as cellular phones, cordless phones, computers, TVs, electronic games, hair dryers, etc.). If the problem still occurs, contact your home care provider for assistance.
The Ramp feature does not work when you press the Ramp button.
Your home care provider did not prescribe Ramp for you, or your therapy pressure is already set to the minimum setting.
If Ramp has not been prescribed for you, discuss this feature with your home care provider to see if they will change your prescription. 
If your provider has enabled Ramp, but the feature still does not work, check the current pressure setting on the Therapy screen. If the therapy pressure \
is set to the minimum setting (4.0 cm H2O), or the Ramp starting pressure is the same as the therapy pressure, the Ramp feature will not work. Make sure that the ramp time setting is >0.
The airflow is much warmer than usual. 
The air filters may be dirty. The device may be operating in direct sunlight or near a heater. 
Clean or replace the air filters.
The temperature of the air may vary somewhat based on your room temperat\
ure. Make sure that the device is properly ventilated. 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.
If using the humidifier with the device, check the humidifier settings. Refer to the humidifier instructions to make sure the humidifier is working properly.
If the problem continues, contact your home care provider.
The airflow pressure feels too high or too low.
The Tubing type setting may be incorrect.
Make sure the Tubing type setting (22 or 15) matches the tubing that you are using (Philips Respironics 22 or 15 mm tubing).
If you are using the Heated Tubing, this setting will be 15H and you cannot change it.
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ProblemWhy It HappenedWhat To Do
Tube Temperature is turned on in “Setup” screen but Heated Tubing is not warm.
Incorrect power supply is being used.
Make sure the 80W power supply is being used or a compatible battery or DC cable is being used.
I’m having difficulty adjusting the heated humidifier setting or the heated tube temperature setting.
The blower is not turned on, or the humidifier or heated tube is not fully connected.
The humidifier setting and tube temperature settings can only be adjusted from the Therapy ON display screen. Confirm that the blower is turned on, and that the settings are visible on the right side of the screen, then adjust to desired comfort. If the blower is on but the humidifier settings are not displayed on the Therapy ON screen, then unplug the device. Confirm that the humidifier and/or heated tube electrical contacts are not obstructed or damaged. Then reconnect the humidifier and/or heated tube, and reconnect the device’s power supply. Turn the blower on; if the settings are still not visible, contact your provider for assistance.
The water in the water chamber runs out before morning.
Water chamber was not full at start of session. Mask leak is excessively high.  The ambient conditions are very dry/cool.
Under most conditions, a full water chamber should last for a typical sleep session. However, many factors impact water consumption, including: the ambient temperature and humidity in your bedroom, your humidifier or heated tube settings, the level of mask leak, and the duration of your sleep session. 
First, make sure that the water chamber is filled to the maximum fill line at the start of your sleep session. Check that your mask is fitted properly, and adjust as needed to reduce mask leak to normal levels. You may use the Check Mask Fit function to evaluate your mask fit. Also, confirm that the device, humidifier, humidifier seals and tube are connected properly and not leaking. You may also choo\
se to lower your humidifier and/or heated tube settings or change the humidification mode from Fixed to Adaptive humidification mode to increase the time that your humidifier water will last.
I hear a leak or whistling sound coming from my therapy device or humidifier (not related to mask leak).
The therapy device air inlet may be obstructed. The humidifier or tube is not fully connected. The humidifier seals are not fully seated or are missing.
Check therapy device air inlet is not obstructed, and filters are clean and properly inserted. Confirm that the device, humidifier, and tube are connected properly and not leaking. Confirm that the humidifier lid seal and dry box seal are present and properly seated; if needed, gently press around the perimeter of the seals to reseat them.
I accidentally spilled water into my humidifier basin.
The water chamber has been filled beyond the maximum fill line.
A small amount of water spilled in the basin of the humidifier will not harm your device. A small spill in the humidifier will evaporate under normal humidifier use. However, too much water in the humidifier basin could spill over the humidifier lid hinge and might damage your furniture. 
Disconnect power from the device. Remove the water chamber, pour out any excess water until the water level is at or below the maximum fill line and set the chamber aside. Separate the humidifier from the therapy device, and pour out the spilled water. Once the heater plate has cooled, wipe the inside of the humidifier with a paper towel or soft cloth. If needed, dry the underside of the humidifier and confirm that your table top is dry. Reconnect the humidifier and power supply, and reinstall the water chamber.
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Accessories
There are several accessories available for your DreamStation system such as a Humidifier, Cellular Modem, 
Wi-Fi Accessory or a Link Module. Contact your home care provider for additional information on the available 
accessories. When using optional accessories, always follow the instructions enclosed with the accessories.
 Caution: Pins of connectors should not be touched. Connections should not be made to these connectors 
unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up 
of electrostatic charge (e.g., air conditioning, humidification, conductive floor coverings, non-synthetic clothing), 
discharging one’s body to the frame of the equipment or system or to earth or a large metal object, and bonding 
oneself by means of a wrist strap to the equipment or system or to earth.
Adding a Humidifier with or without Heated Tubing
You can use the heated humidifier and the heated tube with your device. They are available from your home care 
provider.  A humidifier may reduce nasal dryness and irritation by adding moisture to the airflow. 
 Warning: For safe operation, the humidifier must always be positioned below the breathing circuit connection 
at the mask. The humidifier must be level for proper operation.
Note: Refer to the humidifier’s instructions for complete setup information.
Using the SD Card
The DreamStation system comes with an SD card inserted in the SD card slot on \
the side of the device to record 
information for the home care provider. Your home care provider may ask \
you to periodically remove the SD card 
and send it to them for evaluation.
Updating Software Using the SD card
To check which version of software is currently on your device, navigate to My Provider and select Device Info. 
You can update the device software using the SD card. The software updat\
e must be done when the therapy is off.
1 .  
Insert an SD card with the new software version into the device. A pop-up screen appears asking “Would you 
like to upgrade software?”
2 . Turn the control dial to select Yes and then press the control dial to s\
tart the upgrade. The busy icon appears 
while the upgrade is in progress. Do not remove power from the device.
3 .  
If the software update is successful, the Change Accepted icon appears on the screen. Removed the SD card 
from the device to restart the device and use the new software.
4 . If an SD card error is detected, the Change Rejected icon appears . Remove the SD card and reinsert. If the 
alert continues to occur, contact Philips Respironics at 1-800-345-6443 or 1-724-387-4000 for a new SD card.
Using the DreamStation Link Module
The Link Module is able to receive oximetry data and transfer it to the therapy device for home use or in a laboratory 
setting. For use in a laboratory setting, the Link Module also includes an RS-232 (or “DB9”) port to allow remote 
control of the DreamStation Sleep Therapy Device by a personal computer. 
 Note: Please consult the instructions that accompany the Link Module for installation and removal.
 Note: There are no SpO2 alarms available.
 Note: Oximetry data is not displayed.
To clean the module, remove the module from the therapy device. Wipe the outside of the device with a cloth 
slightly dampened with water and a mild detergent. Let the device dry completely before reinstalling into the 
therapy device.
Dispose of the module following the same disposal instructions for your therapy device.
Warnings:
•  If you notice any unexplained changes in the performance of this device, if it has been dropped or mishandled, 
if water is spilled into the enclosure, or if the enclosure is broken, discontinue use. Contact your home care 
provider.
•  Repairs and adjustments must be performed by Philips Respironics-authorized service personnel only. 
Unauthorized service could cause injury, invalidate the warranty, or result in costly damage.
•  Do not use any accessories, detachable parts, and materials not recommended by Philips Respironics. 
Incompatible parts or accessories can result in degraded performance.
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Adding Supplemental Oxygen
Oxygen can be added to the patient circuit. Please note the warnings listed below when using oxygen with the device\
.
Warnings:
•  When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.
•  Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
•  If supplemental oxygen is added at the exit of the flow generator or humidifier, a Philips Respironics Pressure Valve 
must be placed in-line with the patient circuit between the device and the oxygen source. The pressure valve helps 
prevent the backflow of oxygen from the patient circuit into the device when the unit is off. Failure to use the 
pressure valve could result in a fire hazard.
• When adding oxygen at the mask end of the hose, a Philips Respironics Pressure Valve is not required for oxygen 
flow rates of ≤4 liters per minute. However, the reusable and disposable filters must be in place on the flow 
generator. Failure to install both the reusable and disposable filters could result in a fire hazard.
 Note: Refer to the pressure valve’s instructions for complete setup information.
•  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.
•  Do not connect the device to an unregulated or high pressure oxygen source.
Supplying DC Power to the Device
A Philips Respironics DC power cord can be used to operate this device in a stationary recreational vehicle, boat, 
or motor home. In addition, a Philips Respironics DC battery adapter cable, when used with a DC power cord, 
allows the device to be operated from a 12 VDC free-standing battery. 
Caution: Always ensure that the DC power cord securely fits into your therapy device prior to use. Contact 
your home care provider or Philips Respironics to determine if you have the appropriate DC cord for your 
specific therapy device.
Caution: When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s 
engine is running. Damage to the device may occur.
Caution: Only use a Philips Respironics DC Power Cord and Battery Adapter Cable. Use of any other system 
may cause damage to the device.
Refer to the instructions supplied with the DC power cord and adapter cable for information on how to operate 
the device using DC power.
Traveling with the System
When traveling, the carrying case is for carry-on luggage only. The carrying case will not protect the system if it is put 
through checked baggage. If traveling with the optional humidifier, do not travel with water in the water tank.
For your convenience at security stations, there is a note on the bottom of the device stating that it is medical 
equipment and is suitable for airline use. It may be helpful to bring this manual along with you to help security 
personnel understand the DreamStation device.
If you are traveling to a country with a line voltage different than the one you are currently using, a different power 
cord or an international plug adaptor may be required to make your power cord compatible with the power outlets 
of the country to which you are traveling. Contact your home care provider for additional information.
Airline Travel
The device is suitable for use on airlines when the device is operating from an AC or DC power source. 
Note: It is not suitable for airline use with any of the modems or humidifiers installed in the unit.
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Cleaning the Device
 Warning: To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. 
DO NOT immerse the device in any fluids.
1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild 
detergent. Let the device dry completely before plugging in the power co\
rd.
2. Inspect the device and all circuit parts for damage after cleaning. Repl\
ace any damaged parts.
Cleaning or Replacing the Filters
Under normal usage, you should clean the reusable blue pollen filter at least once every two weeks and replace it 
with a new one every six months. The light-blue ultra-fine filter is disposable and should be replaced after 30 nights of 
use or sooner if it appears dirty. DO NOT clean the ultra-fine filter.
 Caution: Dirty inlet filters may cause high operating temperatures that may affect device performance. Regularly 
examine the inlet filters as needed for integrity and cleanliness.
This device has an automatic air filter reminder. Every 30 days, the device will display a message reminding you to 
check your filters and replace them as directed.
Note: This message is a reminder only.  The device does not detect the performance of the filters nor does it 
recognize when a filter has been cleaned or replaced.
1. If the device is operating, stop the airflow. Disconnect the device from the power source.
2. Remove the filter(s) from the device. Refer to the “Installing/Replacing the Air Filters” section of this manual. 
3. Examine the filter(s) for cleanliness and integrity.
4. To clean the reusable blue pollen filter, first detach the light-blue ultra-fine filter if a pplicable, and set aside or 
dispose of as needed. Then take the reusable filter to the sink, turn it upside down, and run warm tap water 
through the white filter media to rinse away any debris. Next, lightly shake the filter to remove as much water as 
possible. Allow the filter to air dry completely before reinstalling it. If the reusable blue pollen filter is torn, replace 
it. (Only Philips Respironics-supplied filters should be used as replacement filters.)
5. If the light-blue ultra-fine filter is dirty or torn, replace it.
6. Reinstall the filters. Refer to the “Installing/Replacing the Air Filters” section of this manual.
 Caution: Never install a wet filter into the device. You must ensure sufficient drying time for the cleaned filter.
Cleaning the Tubing
Hand wash the tubing and the mask adaptor (if included) before first use and daily. 
For daily cleaning, disconnect the tubing from the device and the mask, and, if included, disconnet the mask 
adaptor from the tubing. For the 12, 15, or 22 mm flexible tubing, gently wash the tubing and mask adaptor in a 
solution of warm water and a liquid dish soap. Rinse thoroughly. Air dry. Inspect the tubing and mask adaptor for 
damage or wear. Discard and replace if necessary.
Note: Refer to the humidifier manual for the instructions on how to clean the heated tube.
Caution: Do not clean the tubing and mask adaptor with bleach, alcohol, solutions containing bleach or alcohol, or 
solutions containing conditioners or moisturizers. 
Caution: Any deviation from these instructions may impact the performance of the \
product.
Service
The device does not require routine servicing. 
 Warning: 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.
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Additional Notices
Notice: The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and 
any use of such marks by Philips Respironics is under license. Other tra\
demarks and trade names 
are those of their respective owners. 
Notice: The DreamStation Therapy Device transmits data between the therapy devic\
e and a mobile 
device, but it does not store any of your personal data. This connection between the therapy 
device and a mobile device is encrypted.
Notice:  This device contains a FCC certified Bluetooth radio module (located on the main board). 
  Only the co-location of this Bluetooth radio with the radio transceivers of the DreamStation Wi-Fi 
Accessory and Cellular Modem has been FCC approved and is permitted. 
 For compliance with FCC RF exposure guidelines a minimum distance of 20 cm between the Wi-Fi 
Accessory or the Cellular Modem and the user’s body should be maintained during operation of one 
of those accessories together with the DreamStation.
Notice: FCC ID: THO1116426
Notice: THO1116426 is the FCC ID of the FCC certified Bluetooth module contained in this device.
Notice: Use of non-original manufacturer-approved accessories may violate your local RF exposure 
guidelines and should be avoided.
Notice:  This device complies with part 15 of the FCC Rules. 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.
  This equipment has been tested and found to comply with the limits for a Class B digital device, 
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection 
against harmful interference in a residential installation. This equipment generates, uses, and can 
radiate radio frequency energy and, if not installed and used in accordance with the instructions, 
may cause harmful interference to radio communications. However, there is no guarantee that 
interference will not occur in a particular installation. If this equipment does cause harmful 
interference to radio, TV reception, or other devices which can be determined by turning the 
equipment on and off, the user is encouraged to try to correct the interference by one or more 
of the following measures:
•  Reorient or relocate the receiving antenna (on the radio, TV, or other device).
•  Increase the separation between the equipment and receiver.
•  Connect the equipment into an outlet on a circuit different from that to which the receiver is 
connected.
•  Consult the dealer of the device for help.
Notice:  Any changes or modifications made to the device that are not expressly approved by Respironics 
may void the user’s authority to operate the equipment.
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Specifications
  Environmental Operating Temperature:  5° to 35° C (41° to 95° F) Storage Temperature:  -20° to 60° C (-4° to 140° F) Relative Humidity (operating & storage):  15 to 95% (non-condensing) Atmospheric Pressure:  101 to 77 kPa (0 - 2286 m / 0 - 7500 ft)
  Physical Dimensions:  15.7 x 19.3 x 8.4 cm (6.2” L x 7.6” W x 3.3” H) Weight (Device with power supply):  Approximately 1.33 kg (2.94 lbs)
  Service Life The expected service life of the DreamStation Therapy Device and Link Module is 5 years.
  Standards Compliance This device is designed to conform to the following standards: IEC 60601-1 General Requirements for Basic Safety and Essential Performance of Medical Electrical EquipmentISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment EN 60601-1-2 Electromagnetic Compatibility RTCA/DO-160G section 21, category M; Emission of Radio Frequency Energy
  IEC 60601-1 Classification Type of Protection Against Electric Shock: Class II Equipment Degree of Protection Against Electric Shock: Type BF Applied Part Degree of Protection against Ingress of Water:    Device:  Drip Proof, IP22   Link Module:  Drip Proof, IP22   80W power supply:  Drip Proof, IP22 Mode of Operation: Continuous
  Electrical AC Power Consumption (with 80W power supply):  100 – 240 VAC, 50/60 Hz, 2.0-1.0 A Note: Power supply is part of the medical electrical equipment. DC Power Consumption:  12 VDC, 6.67 A Fuses:  There are no user-replaceable fuses.
  Radio Specifications Operating Frequency Range:  2402 - 2480 MHz  Maximum Output Power:  4.0 dBm  Modulation:     GFSK, P/4 DQPSK, 8DQPSK
  Intake Port Filters
 Pollen Filter:  100% Polyester
      88% Efficient @ 7-10 micron size
 Ultra-fine Filter:  Blended Synthetic Fiber
      95% Efficient @ 0.5-0.7 micron size
  Declared Dual-Number Noise Emissions Values In accordance with ISO 4871 The A-weighted sound pressure level is:    Device:  26.1 dB(A) with and uncertainty of 2 dB(A).   Device with Humidifier:  27.3 dB(A) with and uncertainty of 2 dB(A). The A-weighted sound power level is:    Device:  34.1 dB(A) with an uncertainty of 2 dB(A).   Device with Humidifier:  35.3 dB(A) with an uncertainty of 2 dB(A).Note: Values determined according to noise test code given in ISO 80601-2-70:2015, using the basic standards ISO 3744 and ISO 4871.
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  Pressure Accuracy
Pressure Increments:  4.0 to 20.0 cm H2O (in 0.5 cm H2O increments)
Maximum static pressure accuracy, according to ISO 80601-2-70:2015: 
PressureStatic Accuracy
10 cm H2O± 0.3 cm H2O
Static pressure accuracy has a measurement uncertainty of 3.7%
Maximum dynamic pressure variation, according to ISO 80601-2-70:2015:  
Pressure10 BPM15 BPM20 BPM
< 10 cm H2O± 0.4 cm H2O± 0.5 cm H2O± 0.8 cm H2O
≥ 10.0 to 20 cm H2O± 0.5 cm H2O± 0.8 cm H2O± 1.0 cm H2O
Dynamic pressure accuracy has a measurement uncertainty of 4.3%
Note: All tests were performed with and without humidifier and with 22 mm and 12 mm standard 
tubes and 15 mm heated tube.
  Maximum Flow Rate (typical)
Test pressures (cm H2O)
4.08.012.016.020.0
22 mm tubingMeasured pressure at the patient connection port (cm H2O)3.77.711.214.918.9
Average flow at the patient connection port (l/min)85124131132128
15 mm tubing (heated or non-heated)
Measured pressure at the patient connection port (cm H2O)3.77.410.914.918.8
Average flow at the patient connection port (l/min)86127134133117
12 mm tubingMeasured pressure at the patient connection port (cm H2O)4.07.011.015.019.0
Average flow at the patient connection port (l/min)859594100102
Disposal
Separate collection for electrical and electronic equipment per EC Directive 2012/19/EU. Dispose of this device in 
accordance with local regulations.
EMC Information
Your unit has been designed to meet EMC standards throughout its Service Life without additional maintenance. There is always an opportunity to relocate your DreamStation Therapy Device within an environment that contains other devices with their own unknown EMC behavior. If you believe your unit is affected by locating it closer to another device, simply separate the devices to remove the condition.
Pressure and Flow Accuracy
The DreamStation Therapy Device is designed to perform within the pressure and flowrate accuracies specified in the user manual. If you suspect that the pressure and/or flow rate accuracy is affected by EMC interference remove power and relocate the device to another area. If performance continues to be affected discontinue use and contact your home care provider.
SpO2 and Pulse Rate Accuracy
The DreamStation Therapy Device is designed to capture the SpO2 and Pulse Rate oximetry data within the accuracy specification described in the sensor manufacture’s instructions for use. When 4 hours of successful oximetry data have been achieved the device indicates this to the user by displaying “Oximetry: Good Study”. If you suspect that your unit is affected by EMC interference remove power and relocate the device to another area. If performance continues to be affected discontinue use and contact your home care provider.
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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions – This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
Emissions TestComplianceElectromagnetic Environment - GuidanceRF emissionsCISPR 11Group 1The device 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 emissionsCISPR 11Class BThe device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network.Harmonic emissionsIEC 61000-3-2Class A
Voltage fluctuations/Flicker emissionsIEC 61000-3-3Complies
Emission of Radio Frequency EnergyRTCA/DO-160G Section 21Category MThis device is suitable for use onboard commercial airplanes inside passenger cabin.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
Immunity TestIEC 60601 Test LevelCompliance LevelElectromagnetic Environment - GuidanceElectrostatic Discharge (ESD)IEC 61000-4-2±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast Transient/burstIEC 61000-4-4±2 kV for power supply lines
±1 kV for input-output lines
±2 kV for supply mains
±1 kV for input/output lines
Mains power quality should be that of a typical home or hospital environment.
SurgeIEC 61000-4-5±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV for common mode
Mains power quality should be that of a typical home or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11
95% dip in UT) for 0.5 cycle at 45 degree increments
70% UT (30% dip in UT) for 0.5 seconds 95% dip in UT) for 5 seconds
95% dip in UT) for 0.5 cycle at 45 degree increments
70% UT (30% dip in UT) for 0.5 seconds
95% dip in UT) for 5 seconds
Mains power quality should be that of a typical home or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic fieldIEC 61000-4-8
30 A/m30 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment.NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
Immunity TestIEC 60601 Test LevelCompliance LevelElectromagnetic Environment - GuidanceConducted RFIEC 61000-4-6
Radiated RFIEC 61000-4-3
3 Vrms150 kHz to 80 MHz
6 VrmsAmateur Radio & ISM Bands between 150 kHz and 80 MHz
10 V/m80 MHz to 2.7 GHz
3 Vrms150 kHz to 80 MHz
6 VrmsAmateur Radio & ISM Bands between 150 kHz and 80 MHz
10 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended 30 cm separation distance.
Interference may occur in the vicinity of equipment marked with the following symbol:   
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