Airbox Instructions for Use - Somnera

36
Airbox Instructions for Use

Transcript of Airbox Instructions for Use - Somnera

Page 1: Airbox Instructions for Use - Somnera

AirboxInstructions for Use

Page 2: Airbox Instructions for Use - Somnera
Page 3: Airbox Instructions for Use - Somnera

1

READ BEFORE USE:

This manual describes the operating methods, technical parameters and maintenance instructions of the device. For future reference, keep this manual in a convenient, easily accessible place.

Warning: Read this entire manual before using this device.

Caution: In the US, federal law restricts this device to sale by or on the order of a physician.

CAREFULLY INSPECT PACKAGE PRIOR TO USE

After unpacking, please check that all the parts are present and intact. If some ofthe parts are missing or damaged, please contact your supplier immediately.The parts are as follows:

• Airbox

• Power Adapter & cord

• User Manual

• Micro SD Card (already installed)

• Air Filter pack

• Travel Bag

• Quick Start Guide

Note: Please retain the packing material in the event the device needs to be returned.

Page 4: Airbox Instructions for Use - Somnera

2

TABLE OF CONTENTS

Chapter 1 Overview ....................................... 41.1 Model Introduction .............................. 41.2 Product Features ................................. 41.3 Structure and Components ................. 41.4 Device Description .............................. 51.5 Indications for Use .............................. 51.6 Contraindications ................................ 51.7 Warnings ............................................. 51.8 Precautions ......................................... 61.9 Adverse Events ................................... 71.10 Environmental Requirements ............. 81.10 Symbol Instructions ........................... 9

Chapter 2 How Does the Airbox Work ........ 102.1 Pneumatic Diagram ............................. 10

Chapter 3 System Setup ............................... 113.1 Connecting the System ....................... 113.2 Connecting the Hose .......................... 113.3 Connecting and Powering the Airbox . 123.4 Powering the Airbox On/Off ................ 12

Page 5: Airbox Instructions for Use - Somnera

3

TABLE OF CONTENTS (CONT.)

Chapter 4 Using the Airbox .......................... 144.2 Starting/Stopping Therapy ................. 144.3 Mask Options ...................................... 154.4 Settings ............................................... 164.5 Micro-SD Card Instructions ................ 23

Chapter 5 Storage and Cleaning ................. 245.1 Storage and Cleaning of the Device .... 245.2 Storing the Device ............................... 245.3 Cleaning the Airbox ............................. 255.4 Changing the Air Filter ......................... 255.5 Troubleshooting .................................. 26

Chapter 6 Product Service ........................... 276.1 Service Life .......................................... 276.2 Waste and Disposal ............................ 276.3 Transportation and Storage ................ 27

Chapter 7 Continued Service ....................... 27Chapter 8 Technical Requirements ............ 28

8.1 Safety Classification ............................ 288.2 Technical Specifications ..................... 28

Chapter 9 EMC Information ......................... 30

Page 6: Airbox Instructions for Use - Somnera

4

CHAPTER 1 OVERVIEW

1.1 Model Introduction 1.2 Product Features

• Low-flow breathing experience

• No humidifier needed

• Small elegant design

• Quiet operation

• Simple touchscreen interface

1.3 Structure and Components

• Airbox

• Plug and power cord

• Air-filter

• Travel bag

• User guide

• Micro-SD card

1. Ambient light sensor2. Display screen3. Display button4. Air outlet port (Hose connects here)5. Air inlet port (Air-filter installed here)6. Micro SD card port7. Power supply port

Somnera™ System AirboxPositive Airway Pressure Device

Model: A1

Airbox - Front View

Airbox - Back View

Page 7: Airbox Instructions for Use - Somnera

5

1.4 Device Description

The Somnera Airbox is used with the Somnera Patient Interface (refer to IFUs) to treat obstructive sleep apnea in the home environment by providing positive airway pressure to a patient during each sleep night. The Somnera Airbox delivers room air to the patient, at a selectable pressure, through the Somnera Patient Interface hose and mask (refer to IFUs). The Airbox is transportable but must be connected to an AC power supply during use using the power cord supplied with the Airbox.

1.5 Indications for Use

The Somnera Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).

1.6 Contraindications

• Severe bullous lung disease

• A pneumothorax

• Pathologically low blood pressure

• Dehydration

• Cerebrospinal fluid leak, recent cranial surgery or trauma

1.7 Warnings

• This device should only be used with the Somnera System mask, hose and accessories. The Airbox is not compatible with any other respiratory systems or accessories. Use of the Airbox with other systems or accessories could reduce the effectiveness of the treatment, result in improper operation or potential safety hazards.

• Do not use this device in an MR environment.

• A magnet is contained in the hose connector of the Airbox. Ensure that the Airbox is kept at least 4” (102 mm) away from any active medical implant (e.g., pacemaker, defibrillator) to avoid possible effects from localized magnetic fields. At this distance, the magnetic field strength is less than 0.5mT.

• Make sure you arrange the hose so that it will not twist around the head or neck.

Page 8: Airbox Instructions for Use - Somnera

6

1.7 Warnings (cont.)

• If you noticed unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled or if the case is broken, disconnect the power cord and discontinue use, then contact your care provider or supplier. Failure to do so could result in improper operation or potential safety hazards.

• Do not place the device directly on carpets, fabrics or other flammable materials.

• Do not place the device in a flammable environment.

• Do not open or modify the device.

• Beware of electrocution. Do not immerse the device or power adapter in water.

• Do not let any fluids enter the device. If liquids are spilled into or on the device, unplug the device and let the parts dry.

• Keep away from any heating appliances such as radiators, etc.so as not to increase the temperature of the air coming into the device.

• Do not use with oxygen.

• Do not place the device in a rich O2 environment. Any sources of oxygen must be located more than 1 m away from the device to avoid risk of fire and burns.

• Do not cover the device or stack with other equipment.

• The Airbox is not intended for use with a humidifier. Do not connect a humidifier to the Airbox.

• Do not insert or remove the SD Card while the Airbox is powered on.

1.8 Precautions

• Carefully inspect the package prior to use for damage to the contents. If the contents are damaged, DO NOT USE and contact your supplier.

• An acute upper respiratory tract infection, sinusitis or an ear infection may require temporary discontinuation of treatment. Consult your healthcare provider.

• Periodically check the power adapter and device for any signs of damage.

• Keep the device away from pets and children.

• Blocking the air hose and/or the inlet of the device while in operation could lead to overheating of the device.

• Orient the Airbox with the display screen face up during use.

• Keep the area around the device dry, clean and clear of anything (e.g., clothes, pillows, bedding) that could block the air inlet or cover the device.

• Remove the Airbox from any container when in use.

• The device should be powered off when not in use.

Page 9: Airbox Instructions for Use - Somnera

7

• Position the device so you can easily plug or unplug from the electrical outlet

1.9 Adverse Events

You should report unusual chest pain, severe headache or increased breathlessness to you prescribing physician. The following side effects may arise during the course of therapy with the device:

• Drying of the nose, mouth or throat

• Nosebleed

• Nasal congestion

• Ear or sinus discomfort

• Skin, nose or eye irritation

• Skin rash

• Headache

• Breathing difficulty or discomfort

• Bloating

• Difficulty sleeping

Page 10: Airbox Instructions for Use - Somnera

8

1.10 Environmental Requirements

Environmental Requirements Working Conditions Storage ConditionsTemperature 41ºF (5ºC) ~ 104ºF (40ºC) -4ºF (-20ºC) ~ 131ºF (55ºC)Relative Humidity 20% ~ 93% 10% ~ 93%, non-condensationAltitude Sea level to 8,500 ft. (2,591 m) N/AOther Requirements Do not use in in an

environment with corrosive, flammable or explosive gases

1. Long-term storage of the device should be in a ventilated room without corrosive gases.

2. Severe shock, vibration, and snow or rain should be avoided during transportation.

• Caution: User should only operate device under proper environmental conditions.

• Warning: The performance of this device may be degraded and the tolerance may exceed the specified value, when the environment and power supply (power or air supply) exceed the limits listed below:

—Ambient temperature: 41ºF (5ºC) ~ 104ºF (40ºC); —Relative humidity: 20% to 93%; —AC supply voltage: ±10% of the rated voltage;

Although it is beyond the requirements of IEC60601-1: 2005, the device does not pose a safety hazard to the patient or operator when it is operated within the above specified environmental and power or air supply conditions.

Page 11: Airbox Instructions for Use - Somnera

9

1.11 Symbol Instructions

Only for indoor use

Refer to instruction manual

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician

Manufacturer Class II equipment

CAUTION: Read all warnings and precautions in instructions for use

Type BF Applied Part

MR unsafe. Do not use in the vicinity of a MRI device.

Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC.

Recyclable Bluetooth Manufacture date

Temperature Range

Catalog number Serial Number

Atmospheric Pressure

Humidity RangeDo not use if package is damaged

Fragile handlewith care

Keep in a dry placeKeep away from sunlight

Drip proof equipment protection against ingress of solid foreign objects 12.5 mm diameter. Protection against ingress of water with harmful effects dripping (15° tilted).

Page 12: Airbox Instructions for Use - Somnera

10

CHAPTER 2 HOW DOES THE AIRBOX WORK?

The Airbox includes the main unit, the power adapter and the cord. The main unit is composed of a blower, control circuits and sensors, and should be used along with the Somnera System Patient Interface (Refer to IFUs). Based on the preset settings, the device delivers positive airway pressure through the hose and nasal mask, to the patient’ s upper respiratory tract to help keep the airway open.

2.1 Pneumatic Diagram

The pneumatic schematic diagram is shown below:

Page 13: Airbox Instructions for Use - Somnera

11

CHAPTER 3 SYSTEM SETUP

3.1 Connecting the System

• Caution: Please refer to the Somnera System Patient Interface Instructions for Use on how to set up the hose, mask, valve and headgear.

3.2 Connecting the Hose

Connect the end of the Hose to the magnetic air outlet port of the Airbox device. Connect the other end of the Hose to the Somnera System Patient Interface based on the usage instructions.

• Caution: While connecting the Hose, do not use excessive force to push or pull as it may damage the Hose and result in air leakage.

Page 14: Airbox Instructions for Use - Somnera

12

3.3 Connecting and Powering the Airbox

Plug the power adapter into the power socket on the back of the Airbox. Insert the power adapter plug into the power outlet. Ensure that you are using the power supply provided by the manufacturer

3.4 Powering the Airbox On/Off

To Power ON the Airbox, lightly tap and hold the oval Display Button until it illuminates, then release.

Page 15: Airbox Instructions for Use - Somnera

13

The LED Screen will illuminate, display Somnera System logo during boot up, and then display the HOME SCREEN.

Power OFF the Airbox from any illuminated screen by lightly depressing and holding the Display Button until the screen displays “Power Off”. Tap and release “Power Off”.

• WARNING: When powering off the Airbox, wait to unplug the Airbox until the Power Button is no longer illuminated. Failure to follow this sequence could result in incomplete transfer of sleep data to the SD Card.

• CAUTION: When any error message appears on the device’ s display screen, stop using the device and check it. Reuse only after the device returns to normal status.

HOME SCREEN

POWER OFF

Page 16: Airbox Instructions for Use - Somnera

14

CHAPTER 4 USING THE AIRBOX

4.2 Starting/Stopping Therapy

From the HOME SCREEN, tap “Therapy” to access the Therapy Screen

To start airflow, tap “Start Therapy” in the bottom left of the display screen.

To stop airflow, tap “Stop Therapy” in the bottom left of the display screen.

Page 17: Airbox Instructions for Use - Somnera

15

4.3 Mask Options

From the HOME SCREEN, tap “Mask Options” to access the Mask Options Screen

The Mask Options main screen displays the following options:

1. Mask Dry – Allows user the option to dry out the mask and valve after cleaning the components prior to using the device for therapy

Mask Dry

Tap “Start”

The device will blow air through the Patient Interface for 15 minutes and then stop. Repeat Mask Dry, as necessary, to dry the Patient Interface.

Tap “Exit” button to go back to the Mask Options screen.

Page 18: Airbox Instructions for Use - Somnera

16

4.4 Settings

From the HOME SCREEN, tap “Settings” to access the Settings Screen

Settings screen overview:

GoToSleep™ – Allows the user to set a timer to delay the start of the Airbox therapy while wearing the fully connected User Interface.

Ramp – Allows the user to set a timer to gradually increase the pressure to the set pressure.

Auto Start Therapy – Automatically starts therapy when breathing is detected.

Mask Type – Patient Interface selections

Hose – Displays the hose setting – 9mm

Airplane Mode – On/Off

Bluetooth - On/Off

Power Saving - On/Off optimizes power draw.

Display Settings – User programmable brightness on the display as well as the time it takes for the display to dim.

Device Info – Device serial number, hardware, firmware and software information

Page 19: Airbox Instructions for Use - Somnera

17

GoToSleep™ Setting

In the Settings menu, turn GoToSleep “ON” by tapping the white circle to the right (circle becomes blue).

Tap GoToSleep to open up the programmable menu.

GoToSleep™ Menu

Select a time between 1 and 45 minutes and then tap “Accept”.

When the therapy is started, the device will wait for the GoToSleep selected minutes before turning on the airflow.

NOTE: If a ramp is also selected, it will begin after the GoToSleep time.

Ramp Setting

In the Settings menu, turn Ramp “ON” by tapping the white circle to the right (circle becomes blue).

Tap Ramp to open up the programmable menu.

Page 20: Airbox Instructions for Use - Somnera

18

Ramp Setting

Select a time between 1 and 45 minutes and then tap “Accept”.

When the therapy is started, the device will gradually increase pressure over the selected time period to reach the prescribed pressure.

Auto Start Therapy

In the Settings menu, turn Auto Start Therapy “ON” by tapping the white circle to the right (circle becomes blue).

The Airbox will detect when the user starts breathing through the mask and will automatically start therapy without the user having to tap “Start Therapy” button.

(Note: If the User also selected GoToSleep, the device will be on but will delay starting airflow for the programmed GoToSleep time.)

Mask Setting

In the Settings menu, tap Mask.

Tap on the grey arrow > to open the Mask selection screen.

Page 21: Airbox Instructions for Use - Somnera

19

Mask Setting

Tap on the circle next to the mask type being used, then tap “Accept”.

Airplane Mode Setting

In the Settings menu, scroll down to Airplane Mode. To turn Airplane mode “ON”, tap the white circle to the right (circle becomes blue).Selecting Airplane Mode “ON” automatically turns Bluetooth “OFF”.

Note: After turning Airplane Mode “OFF”, turn Bluetooth back “ON” to allow sleep data to be added to your App.

Bluetooth Setting

In the Settings menu, turn Bluetooth “ON” by tapping the white circle to the right (circle becomes blue).

Refer to the instructions for your smart device to pair with your Airbox. Look for “Airbox” in your smart device. The serial number for your Airbox will also be displayed.

Page 22: Airbox Instructions for Use - Somnera

20

Power Saving Setting

In the Settings menu, scroll down to the Power Saving setting. Slide the button to the right to turn Power Saving to the “On” position to enable this feature.

Display Settings

In the Settings menu, tap on the grey arrow > to the right of Display Settings to open the programmable menu.

Display Settings

Tap on the grey arrow > to the right of Brightness or Display Dim Duration to open the programmable menus.

Page 23: Airbox Instructions for Use - Somnera

21

Display Brightness Setting

Your Airbox will come with this Auto feature pre-selected. To manually adjust the brightness, tap the white circle to the right (circle becomes blue).

Display Brightness Manual Setting

Select a level between 1-100 percent then tap “Accept”.

Display Dim Duration Setting

Select a time between for 1-10 minutes then tap “Accept”.

Page 24: Airbox Instructions for Use - Somnera

22

Device Info

Tap on the grey arrow to the right of Device Info to view the device information.

Device Information

On this screen, view the serial number, hardware, firmware and software information.

Note: This information cannot be changed.

Page 25: Airbox Instructions for Use - Somnera

23

4.5 Inserting and Removing the Micro SD Card

The Airbox has a slot on the back that accepts a micro SD card.

• Warning: Power off and then unplug the Airbox before removing or inserting the SD card

The micro SD card has a printed side and a metal contact side.

Insert the micro SD card into the Airbox slot with the printed side up and the notched side pointed toward the power cord receptacle.

Use a fingernail to push the micro SD card into the slot until you feel it click.

To remove, push the micro SD card into the slot until it releases/ejects.

Page 26: Airbox Instructions for Use - Somnera

24

CHAPTER 5 STORAGE AND CLEANING

5.1 Storage and Cleaning of the DeviceUnplug the Power Cord

1. After use, Unplug the power cord from the power outlet and from the rear panel of the Airbox.

• Warning: Wait to unplug the Airbox until the Display Button is no longer illuminated. Failure to follow this sequence could result in incomplete transfer of sleep data to the SD Card.

Separating the Hose

2. Hold the hub of the Hose that connects to the Airbox and gently pull the Hose away from the device.

5.2 Storing the DeviceWhen not in use, store device in a cool, dry environment.

Page 27: Airbox Instructions for Use - Somnera

25

5.3 Cleaning the Airbox

Gently wipe the Airbox by using a soft damp towel moistened with water, and then use a soft dry cloth to dry.

• Warning: Do not let any liquid enter the Airbox as permanent damage can occur.

• Warning: Always turn off the device and unplug the power cord from the power outlet before any cleaning.

5.4 Changing the Air Filter

1. Pull the filter cover down and remove the old air filter.

2. Insert a new air filter and close the filter cover.

Filters cannot be washed. Filter replacement is recommended every two weeks. Contact your supplier to order replacement filters.

• Caution: Make sure the air filter cover is closed at all times to help prevent water and dust from entering the device.

• Caution: Only use the air filters provided by the manufacturer.

Page 28: Airbox Instructions for Use - Somnera

26

5.5 Troubleshooting

Please refer to the table below for troubleshooting. If you cannot solve the problem yourself, please contact your supplier.

Problem Probable Cause What to Do

Display will not power on

Power cord connection is loose

Reconnect the power supply cord and ensure that the power supply is plugged into an outlet.

No airflow at the mask

GoToSleep setting is turned onWait for GoToSleep time to complete or change GoToSleep setting.

Airflow not turned on Tap “Start Therapy”

Hose not connected correctlyRecheck that both ends of the hose are correctly connected

Low airflow in the mask

Hose leak or blockageCheck for hose leaks and confirm hose is not kinked or positioned underneath your body.

Ramp is turned onWait for Ramp time to complete or change Ramp setting.

The air filter may be dirty Replace the air filter.

Hose not connected correctlyRecheck that both ends of the hose are correctly connected

Excessive noise

Improper Hose connectionInspect and reconnect the Hose correctly.

Improper Mask positionMake sure the mask is correctly positioned and held in place by the headgear

System failure Indication: E08 – Blower Fault

Component malfunction

Re-start device. If this persists, discontinue use of the device, power it off and contact your dealer or manufacturer.

Page 29: Airbox Instructions for Use - Somnera

27

CHAPTER 6 PRODUCT SERVICE

CHAPTER 7 CONTINUED SERVICE

6.1 Service Life

The service life of the Airbox is 5 years. After the product exceeds its service life, the Airbox should be disposed of per local laws and regulations.

6.2 Waste and Disposal

Dispose according to local and national laws and regulations.

6.3 Transportation and Storage

When not in use, the device should be stored in a cool, dry place.

The manufacturer warranty period of the Somnera Airbox is 2 years from the date of purchase as long as the following conditions are met:

1. Storage and working environments meet the national standards and requirements specification;

2. Airbox is commissioned only by manufacturer certified personnel.

3. Device is used in accordance with the operating instructions.

If any failure or damage occurs due to product quality problems within the limited warranty period, the company will provide free replacement.

Note: Air filters are considered consumable and are not within the scope of the warranty.

Product failure or damage caused by the following circumstances, are not within the scope of the manufacturer warranty:

1. Breakdown or damage caused by improper operation or failure to follow the instructions including any usage beyond the indication of the device.

2. Breakdown or damage caused by the repair, modification or inspection performed by unauthorized service personnel.

3. Breakdown or damage caused by natural disasters such as fire, flood, earthquake or lightning.

Note: Do not attempt to disassemble the product. This will void the warranty.

Page 30: Airbox Instructions for Use - Somnera

28

CHAPTER 8 TECHNICAL REQUIREMENTS

8.1 Safety Classification

• Type of Protection Against Electric Shock: Class II Equipment

• Degree of Protection Against Electric Shock: Type BF Applied Part (Patient Interface Hose only)

• Degree of Protection Against Ingress of Water: IP22

• Mode of Operation: Positive Airway Pressure

• Classification based on the safety degree when using flammable anesthetic mixture in combination with air, or in combination with oxygen or nitrous oxide: This device cannot be used with a flammable anesthetic mixture in combination with air, or in combination with oxygen or nitrous oxide

• Power supply: Power adapter: Input: 100-240V AC, 50/60Hz; Output: 12V DC.

• Input power: 3A

8.2 Technical Specifications

Model: A1Function Single-levelWorking Mode PAP, APAP

Setting Pressure regulation range

For PAP mode: Adjustable levels from 4cmH2O to 20cmH2O, with increments of 1 cmH2O; the upper limit should be less than or equal to 40cmH2O in single fault state.

For APAP mode: Adjustable range on Minimum and Maximum from 4cmH2O to 20cmH2O, with increments of 1 cmH2O; the upper limit should be less than or equal to 40cmH2O in single fault state.

NoiseWhen operating pressure is 10cmH2O, the device sound power should be less than or equal to 44 dBA with uncertainty of 2.5 dBA

Page 31: Airbox Instructions for Use - Somnera

29

Flow (maximum) at set pressures

PressurecmH2O (hPa)

Somnera SystemL/min

48121620

1523283336

Air Filter Polyester Fiber: 83% average dust weight arrestance per EN779Pressure Accuracy Maximum static pressure variation: ± (0.5cm + 2%) cm H2OWeight 0.6[kg] (1.3[lb])

Device Dimensions

Height = 68[mm] (2.7[in])Width = 88[mm] (3.5[in])Length = 133[mm] (5.2[in])

• Caution: MAX pressure at the patient connector in normal state: 20cmH2O in PAP or APAP mode; MAX pressure at the patient connector in single fault state should not exceed: 40cmH2O in PAP or APAP mode.

• Caution: Before the device is used for any patient, the healthcare provider should ensure compatibility and connection of only Somnera System parts and accessories.

• Caution: The healthcare provider should ensure that the patient’s treatment pressure is set correctly, and the therapeutic effect of the settings should be regularly assessed.

Note:

• The product does not contain PVC, DEHP or phthalates.

• This product is not made with natural rubber latex.

• The manufacturer reserves the right to change these specifications without notice.

Page 32: Airbox Instructions for Use - Somnera

30

CHAPTER 9 EMC INFORMATION

Note: This device fulfills the requirements of EN60601-1-2:2015, IEC 60601-1-2-2014, IEC 60601-1-11:2015.Note: Device should be used according to the file for electromagnetic compatibility.Note: It could cause electric shock or harm if the device is used with components or accessories that are not authorized by the manufacturer.

Guidance and manufacturer’s declaration – electromagnetic emissionsThe device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment – guidance

RF emissionsCISPR 11

Group 1The device uses RF energy for its function. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.

RF emissionsCISPR 11

Class B

The device is suitable for use in all establishments including domestic establishments and those directly connected tothe public low-voltage power supply network.

Harmonic distortionsIEC 61000-3-2

Class A

Voltage fluctuations/flicker emissionsIEC 61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunityThe device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.

IMMUNITY test IEC 60601 test level Electromagnetic environment – guidance

Electrostatic discharge (ESD)IEC 61000-4-2

± 2 kV, ± 4 kV, ± 6 kV,± 8 kV air, ± 15kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Page 33: Airbox Instructions for Use - Somnera

31

Radiated Immunity (IEC 610004-4-3)

80 MHz to 2700 MHz10V/m (rms)385 MHz 27V/m (rms)450 MHz 28V/m (rms)710 MHz, 745 MHz,780 MHz 9V/m (rms)810 MHz, 870 MHz,

930 MHz 28V/m (rms)1720 MHz,1845 MHz,1970 MHz 28V/m(rms)2450 MHz 28V/m(rms)5240 MHz, 5500 MHz,5785 MHz 9V/m (rms)

Electrical fast transient/burstIEC 61000-4-4

± 2 kV for power supply lines± 1 kV for input/output lines

Mains power quality should be that of a typical home environment.

SurgeIEC 61000-4-5

±0.5kV, ± 1 kV line(s) to line(s)± 2 kV line(s) to earth

Mains power quality should be that of a typical home environment.

Conducted Immunity (IEC 61000-4-6)

150KHz to 80MHz 3VrmsISM and amateur radio bands between 150KHz to 80MHz 6Vrms

Voltage dips, and InterruptionIEC 61000-4-11

0%, 70%, 0% of UT

Mains power quality should be that of a typical home 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 magnetic fieldIEC 61000-4-8

50Hz, 60 Hz 30A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical home environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Page 34: Airbox Instructions for Use - Somnera

32

The Somnera Airbox is capable of transmitting data to a mobile device through Bluetooth BLE connection. The Airbox contains a FCC certified Bluetooth radio module and complies with FCC PART 15 SUBPART C. The Bluetooth module uses Bluetooth BLE 4.1, operates within a frequency range of 2404 – 2480 MHz, uses GFSK, P/4 DQPSK, 8DQPSK modulation, and has a maximum RF power output of +10dBm.

The Airbox generates, uses, and can radiate radio frequency (RF) energy. Radiated RF electromagnetic fields were successfully tested to the IEC61000-4-3 standard from 80Mhz to 2.7GHz. These limits are designed to provide reasonable protection against interference in a typical residential environment.

There is no guarantee that interference will not occur from other portable and mobile RF communication equipment you may have in your home environment. If you believe your Airbox is being affected by other RF equipment, you are encouraged to try to correct the interference by one or more of the following measures:

• Increase the separation between the RF equipment and your Airbox.

• Reorient or move the RF equipment receiving antenna or cables

• Connect the RF equipment into an outlet on a circuit different from the one connected to your Airbox.

If you continue to have problems, consult your Airbox medical supplier for help.

03-5290 Rev BAugust 6, 2020

Manufacturer: Somnera, Inc., 1291 Puerta Del Sol, Suite 200, San Clemente, CA 92673

See www.somnera.com for other Somnera locations worldwide. For patent information, see www.somnera.com/ip.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.

SOMNERA is a trademark of Somnera Inc. All rights reserved. © 2020 Somnera Inc.

Page 35: Airbox Instructions for Use - Somnera
Page 36: Airbox Instructions for Use - Somnera