Philips HH1600/03 Manuel utilisateur

User manual

SmartSleep

User manual

Manuel d’utilisation

3

Intended Use

SmartSleep is a biofeedback device intended to reduce daytime sleepiness associated

with short sleep duration in adults who do not get enough sleep due to lifestyle. It may

be used in the home environment and is indicated for single consumer use.

Note

SmartSleep does not work for everyone. Because it functions by providing tones during

your deep sleep phase, if you are not naturally reaching your deep sleep phase, or

are not staying in that phase very long, SmartSleep may not increase your slow wave

activity. It also may work for you on some nights but not others because of variability in

sleep patterns. Things that can impact your deep sleep duration include age, alcohol,

certain medications, or sleep disorders. To determine if SmartSleep is delivering

tones while you sleep, check your SleepMapper mobile app metrics. If you nd

that SmartSleep is not delivering tones, please call Philips Customer Care

at 1-844-463-8944.

Use the checklist below to help determine if SmartSleep is right for you.

• I am 18 years or older.

• I typically fall asleep within 30 minutes of trying to fall asleep.

• I typically sleep at least ve (5) hours, but less than seven (7) hours a night on

work or school nights.

• I have not been diagnosed with a sleep disorder (e.g., sleep apnea, insomnia).

• I don’t regularly wake up during the night and have trouble falling back asleep

(>30 minutes).

• I do not regularly use medications or alcohol to help me fall or stay asleep.

• I do not have hearing impairment preventing me from hearing 80 decibels.

A person’s slow wave amplitude naturally reduces with age. SmartSleep will not be

eective if you have low amplitude slow waves which occurs after age 50. SmartSleep is

recommended for people age 50 and under.

Warnings

• Never operate the device if any parts are damaged or if it is not working

properly. Periodically inspect the cables for damage or signs of wear.

Discontinue use and replace the USB cable and charger if damaged.

• If you notice any unexplained changes in the performance of the device,

discontinue use and contact Philips Customer Care for support.

• Do not open, disassemble, or modify the device. There are no user serviceable

components in the SmartSleep device.

• Keep device dry.

• Do not reach for a corded device that has fallen into water. Unplug immediately

from the power outlet.

• Use device only in a dry condition. Do not use while bathing or in a shower.

• Do not place or store the device where liquids may spill on it. Do not place or

drop the device into water or other liquid.

• After cleaning or if the device gets wet, allow the device and forehead sensor to

air dry completely before use.

English

4

• Unplug this device before cleaning.

• Always attach the USB cable and charger to the device rst, then to a power outlet.

• Do not use SmartSleep if your room temperature is warmer than 35°C (95°F). If

you wear SmartSleep in excessively warm environments, the device may cause

irritation or injury to your skin.

• The battery used in this device may present a re or chemical burn hazard if

mistreated. Do not disassemble, expose to temperatures above 60°C (140°F), or

incinerate.

• Portable and mobile RF communications equipment can aect Medical

Electrical Equipment.

• While charging or using the device, do not place it on top of or next to any other

electrical equipment as it may aect performance of the device or equipment.

• This device is considered medical electrical equipment and needs to be used in

accordance with the EMC information provided in this manual.

• Only use the USB cable and charger provided with your device. Use of a USB

cable and charger not approved by Philips may cause overheating, damage

to the device, increased emissions or decreased immunity, or aect EMC

performance and should be avoided.

• Do not stop any of your prescribed medicines while using the device.

• When charging, always ensure that the USB cable and charger is securely

connected to both an AC outlet and the device’s power inlet to prevent arcing.

Do not use extension cords with this device, and do not connect to a computer

to charge the device as it may cause damage.

• Keep the USB cable and charger away from heated surfaces.

• Never drop or insert any object into any opening.

• The device is not designed to work as indicated when the USB cable is

connected. The USB cable is only to be used for charging.

• Do not use the device in the presence of a ammable anesthetic mixture

in combination with oxygen or air, in the presence of nitrous oxide, or in an

oxygen-enriched environment.

• Do not use if there is any skin irritation, inammation, or redness.

• SmartSleep sensors may pose a choking hazard. Do not let children handle the sensors.

• Children should be supervised to ensure they do not play with the device.

• Close supervision is required when this device is used by, on, or near children, or

persons with limited physical, sensory, or mental capabilities or invalids.

Cautions

• Do not use or store this device outside of the specied environmental conditions

listed in this manual.

• This device contains a lithium ion battery. It is important to dispose of this

device in a safe manner in accordance with local regulations.

• If you do not intend to use the device for several weeks, it is important that you

fully charge the device before storing.

• Condensation may damage the device. If the device has been exposed to either

very hot or very cold temperatures, allow it to adjust to room temperature

(operating temperature) before using the device. Do not operate the device

outside of the operating temperature range shown in the Specications section

later in this manual.

5

• Do not submerge the headband in water. This will damage the internal electrical

components and speakers.

• Reseal the sensor pouch after opening to keep the remaining sensors from drying out.

Refer to page 14 for the Symbols Glossary.

Package Contents

The SmartSleep device consists of the components listed below.

SmartSleep Headband and Sensors

A

B

C

D

E

F

G

H

I

J

K

Letter Device Feature Letter Device Feature

A Power Button G Speaker

B Status Indicator Light H Forehead Sensor Connector

C Inner Lining I Forehead Sensor

D Forehead Sensor Band J Adjustability Slider

E SmartSleep Sensor Connector K Charging Port

F SmartSleep Sensor

SmartSleep Sensors (30)

USB Cable and

Charger

User Manual and

Quick Start Guide

SmartSleep Headband

6

First Time Setup

Read all provided instructions for use before proceeding.

1. Remove the SmartSleep headband, USB cable, and charger from the box. The

SmartSleep device will arrive partially charged, but not charged enough for the rst

night of use.

2. Connect the USB cable to the charging port on the device and the charger. Then, plug

the charger in to a wall outlet to charge for 2-3 hours. The indicator light will display

a pulsing orange light while charging and change to solid green when charging is

complete. The status indicator light will turn o and the device will enter power-save

mode 30 minutes after charging is complete.

Note

When charging the device, make sure the USB cable and charger are easily

accessible. The power button cannot be used to turn the device o while it is

charging. Unplugging the charger from the wall outlet is the only way to turn the

device o during charging.

Caution

Do not connect to a computer to charge the device as it may

cause damage.

Using the optional mobile application:

3. Download the SleepMapper application from the App Store or Google Play.

SleepMapper Icon

4. Follow the instructions on your screen to complete your registration.

5. While the device is still plugged in and charging, follow the instructions in the

application to pair your device. Your SmartSleep device will be automatically

detected by the app.

Notes

The status indicator light will turn o 30 minutes after charging is complete. If

this happens, press the headband power button for 1 second to “wake” it before

syncing.

Make sure Bluetooth® is turned on on your phone.

6. After the headband has nished charging, remove the USB cable and charger before

each use.

7

Nightly Use

1. Wash your face and the area behind your right ear with mild soap and water. Dry

completely.

2. Visually inspect the headband prior to use for any damage.

3. Remove a SmartSleep Sensor from its pouch. Reseal the pouch to keep the

remaining sensors from drying out.

Note

The gel in the middle of the SmartSleep Sensor is very important to its function.

If the gel comes dislodged, discard the sensor and start again with a new one.

4. Move your hair away from the area behind your right ear. There should be no hair

between your skin and the sensor.

5. Place the SmartSleep Sensor on the bone behind your right ear.

Comfort tip

Place the sensor close to the hairline.

6. Place the SmartSleep headband on your head so that the forehead sensor is straight

across your forehead.

7. If you have long hair, pull the SmartSleep headband over your head until it is around

your neck and under your hair. Then, pull it up onto your head like a headband. This

helps move your hair away from behind your ear.

8

8. Snap the SmartSleep Sensor connector onto the SmartSleep Sensor behind your

right ear.

9. Cover your ears with the fabric headband.

10. Position the movable integrated speakers so that they rest over your ears.

11. Adjust the sliders in the back so that the headband ts snugly, but comfortably, on

your head. It should not feel “tight” on your head.

9

12. Check that the forehead sensor band is positioned across your lower forehead, and

is not touching your eyebrows or hairline. There should be no hair between your skin

and the sensor. You can also put a dab of water on your forehead under the forehead

sensor to help it connect.

13. Turn on the device by pressing the power button for 1 second. This will enable the

start of your sleep session.

Note

Especially when seasons are changing, and the air tends to be dryer, it may be

more of a challenge to get your headband connected to use at night. Put a dab

of water on your forehead under the forehead sensor to help it connect.

Headband Set Up

After pushing the power button for 1 second, the headband will start to beep. The

headband will continue to beep, and the status indicator light will display a solid

orange light. This is indicating that you do not yet have a connection set up between the

headband and sensors. The headband should stop beeping before you to go sleep.

The headband may take 15-30 seconds to set up the connection to the sensors. If the

beeping does not stop and the indicator light does not turn green after this time, ensure

that there is no hair trapped between your skin and the sensors, and try putting a dab

of water on your forehead under the forehead sensor to help it connect. The headband

will continue trying to set up until you either make a connection with the sensors, run

out of battery, or turn it o. Consult the troubleshooting guide if you cannot set up the

headband.

Once your headband sets up successfully, it will stop beeping, and the status indicator

light will turn green. You are ready to sleep!

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What to Expect

• After headband set up, the green light will stay on for 1 minute, then turn o.

The headband is still working and connected.

• How to check that the headband is still working and connected:

Press the power button for 1 second and view the indicator light in a mirror or

hear the beeping.

• The headband and app are not connected during use.

The headband and app do not communicate with each other during the night.

Your phone could be turned o completely and the headband would still

function normally. The Bluetooth on the headband will not be functioning

until you remove it and sync your data in the morning.

• During sleep, you will not notice the tones.

The volume of the tones are specically calibrated to you, and will play more

quietly if they are disturbing your sleep. You should not expect to hear or

notice sounds during sleep.

• If you get up in the middle of the night, no action is required.

The device will continue to function normally. Simply, go back to sleep when

you are ready.

In the Morning

1. Unsnap the SmartSleep Sensor connector from behind your ear and lift the

headband o of your head.

2. Remove the SmartSleep Sensor from behind your ear. If the gel is still present and

the sensor is still sticking well, you can place the sensor back on the card and reseal

the pouch. Otherwise, discard it.

3. Connect the USB cable to the charging port on the device and the charger. Then, plug

the charger in to a wall outlet.

Notes

This step is important. It ends your sleep session so that you can sync your sleep

data with the app, and ensures that the headband is charged and ready to use

for the next night.

You should charge your headband after each sleep session.

Caution

Do not connect to a computer to charge the device as it may

cause damage.

11

Viewing your Sleep Data

Note

The status indicator light will turn o 30 minutes after charging is complete. If

this happens, press the headband power button for 1 second to “wake” it before

syncing.

4. To view your sleep data, press the power button on the headband for 1 second. Then,

open the mobile application on your phone.

5. Press the “sync” button on your phone screen to begin the data syncing. You

must be within Bluetooth range of your headband in order to sync.

If you miss syncing in the morning, your data will be saved and can sync with your app

the next time you have the device on and the app open at the same time.

Care and Maintenance

Cleaning

Caution

Do not submerge the headband in water. This will damage the internal electrical

components and speakers.

Weekly

Ensure the device is turned o and is not connected to the USB cable and charger before

cleaning.

1. Forehead Sensor Cleaning

a. Remove the forehead sensor from the forehead sensor band by untucking the

ends and unsnapping it from the band.

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b. Submerge the forehead sensor into a solution of dish soap and water. A soft

bristled brush may be used.

c. Rinse thoroughly.

2. SmartSleep Headband Cleaning

Using 3 pre-moistened facial/makeup remover towelettes, clean the wipeable inner

lining. Use a minimum of 3 towelettes to ensure fabric is cleaned.

3. Visually inspect the forehead sensor and the SmartSleep headband for cleanliness.

Repeat the cleaning steps as necessary until visibly clean. A soft bristled brush may

be used.

4. Allow the forehead sensor and the SmartSleep headband to air dry before next use.

Note

Do not place fabric parts into a washing machine, dishwasher, hairdryer, or

clothes dryer.

Caution

Any deviation from these instructions may impact the performance of the

device.

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Component Replacement:

Replacement parts and accessories may be purchased on our website:

www.philips.com/store.

Do not use each SmartSleep Sensor more than 3 nights because it could aect device

performance. The SmartSleep Sensor is considered a disposable component and should

be replaced at least every 3 nights.

Note

The gel in the middle of the SmartSleep Sensor is very important to its function.

If the gel becomes dislodged, discard the sensor and use a new one.

Routine Service

There are no user serviceable components in the SmartSleep device.

Device Firmware Version

To check your device’s current rmware version and update if necessary:

1. Open SleepMapper on your mobile device.

2. Navigate to the “My devices” screen by opening the “... More” tab, selecting “My

devices” (SmartSleep), and selecting the “My devices” screen.

3. If an update for your device is available, it will be indicated on the “My devices”

screen.

4. To update your device, select “SmartSleep update.” Then, click the “Update” button.

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SmartSleep - Headband Controls

Short press (1 second): Turns on the device or “wakes” it during a sleep session.

Extended press (3 seconds): Turns o the device.

Factory Reset: A factory reset will delete all existing data. With the USB cable

and charger connected, press and hold the power button for 15 seconds.

The indicator light will begin to ash green indicating the factory reset has

completed.

Audio and Visual Device Indicators

Charging Indicators

When the headband is connected to the USB cable and charger, and the charger is

plugged into a wall outlet, the headband will display one of the following indicators:

Indicator Light Meaning

Pulsing orange Headband is charging.

Double pulsing orange Headband battery is below the critical battery level. Continue

charging. Syncing cannot occur at this time.

Rapid ashing orange Headband is connected to an unapproved charger. Use the

charger supplied with your device.

Solid green Headband is fully charged.

Light is o while

headband is plugged in

Headband has been fully charged for at least 30 minutes and

has gone into “power-save mode.”

To check the power status of the headband when it is not connected to the USB cable

and charger, press the power button for 1 second. The headband will display one of the

following indicators during the button press:

Indicator Light Meaning

Solid orange Battery is not fully charged.

Solid green Battery is fully charged.

Double pulsing orange Headband battery is below the critical battery level. Charge

immediately. Syncing cannot occur at this time.

Battery status can also be checked while the headband is turned on using the mobile

app by opening the “Control” tab, pressing “My SmartSleep”, and viewing the Battery

level.

Headband Connection Indicators

To check the status of the headband connection to the sensors while wearing the

headband, press and release the power button. The headband will display one of the

following indicators:

Indicator Light Audio Meaning

Solid orange Continuous beeping Sensors are not making contact.

Solid green Beeping stops Sensors are making contact.

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Troubleshooting Guide

Problem Solution

Unable to sync the headband

with the app.

Check that Bluetooth is turned on on your phone.

Ensure that your phone and headband are in close

range to enable the Bluetooth to connect.

Turn the headband o (3 second press) and back on

(1 second press).

Try a factory reset. With the USB cable and charger

connected, press and hold the power button for 15

seconds. The indicator light will begin to ash green

indicating the factory reset has completed.

Headband does not turn on

when power button is pressed.

Ensure that the headband is charged by plugging

it in to the wall outlet. The status indicator light will

display a solid green light if it is fully charged.

Cannot achieve successful

connection for use.

Put a dab of water on your forehead under the

forehead sensor to help it connect.

Ensure that the device is fully charged and

powered on.

Check that the SmartSleep Sensor is placed on

the bone behind the right ear and that no hair is

underneath it. Check that the sensor connector is

snapped to the sensor.

Check that the sensor band is placed across the

middle of your forehead and that there is no hair

underneath it.

Headband indicator light pulses

green and orange.

A device error has occurred. If the green/orange

pulsing light is displayed for longer than 5 seconds,

press the power button to clear the error. If the green/

orange pulsing light continues, contact customer care

for support.

If you are not able to resolve your problem using this troubleshooting guide, or if you

require assistance setting up, using, or maintaining your device contact Philips Customer

Care for support.

Customer Care

For assistance, visit our website: www.philips.com/support or call toll free

1-844-463-8944. Online information is available 24 hours a day, 7 days a week.

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Disposal

Dispose of the device and accessories in accordance with local regulations. It is

recommended to factory reset your device before disposal.

• This product contains a rechargeable lithium-ion battery, which must be

disposed of properly.

• Contact your local town or city ocials for battery disposal information. You

can also call 1-800-822-8837 or visit www.call2recycle.org for battery drop-o

locations.

• For assistance, visit our website: www.philips.com/support or call

1-844-669-9935.

• Your product is designed and manufactured with high quality materials and

components, which can be recycled and reused. For recycling information,

please contact your local waste management facilities or visit

www.recycle.philips.com.

Symbols Glossary

Symbol Denition Symbol Denition

Power Button

X

Headband size indicator. Will

appear as M for medium or L

for large.

Consult instructions for use. Class II (Double Insulated)

Bluetooth symbol Type BF Applied Part

Complies with Part 15 of the FCC

rules.

Detachable battery charger

IP22

Drip Proof Equipment

Protection against ingress of solid

foreign objects ≥ 12.5 mm diameter.

Protection against ingress of water

with harmful eects dripping

(15° tilted).

USB connector

AC Power

DC Power

Refer to http://www.symbols.philips.com for more information.

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Electromagnetic elds (EMF)

This headband complies with all applicable standards and regulations regarding

exposure to electromagnetic elds.

Specications

Dimensions: 2.36” L x 5.12” W x 2.95” H (60 mm L x 130 mm W x 75 mm H)

Weight: Approximately 3.88 oz (110 g)

The expected useful life of the headband and battery is 2 years. The expected useful life

of the SmartSleep sensors is up to 3 uses.

Classications and Standards Compliance

Classications

Type of Protection Against

Electric Shock

Class II Equipment/Internally powered

Degree of Protection Against

Electric Shock

Type BF Applied part

Degree of protection against

harmful ingress of water

Device: IP22, Drip Proof

Charger: IP20

First characteristic numeral - 2 - Protection against

ingress of solid foreign objects ≥ 12.5 mm diameter.

Explanation: Protected against access to hazardous

parts with a nger and protected against solid foreign

objects of 12.5 mm diameter and greater.

Second characteristic numeral - 2- Protection against

ingress of water with harmful eects dripping (15° tilted).

Explanation: Protected against vertically falling water

drops when enclosure tilted up to 15°.

Mode of Operation Continuous operation

• Not suitable for use in the presence of a ammable anesthetic mixture in

combination with oxygen or air, in the presence of nitrous oxide, or in an

oxygen-enriched environment.

Standards Compliance

5010469

ETL Classied

Conforms to:

• AAMI STD ES60601-1

• IEC STDS 60601-1-6, 60601-1-11, & 62304

Certied to:

• CSA STD C22.2 # 60601-1

The SmartSleep device is designed to conform to the following standards:

• IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for

Basic Safety and Essential Performance

• IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements

for Basic Safety and Essential Performance – Collateral Standard:

Electromagnetic Disturbances – Requirements and Tests

• IEC 60601-1-11 Medical Electrical Equipment – Part 1-11: General Requirements

for Basic Safety and Essential Performance – Collateral Standard: Requirements

for Medical Electrical Equipment and Medical Electrical Systems Used in the

Home Healthcare Environment

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• IEC 60601-1-6 Medical Electrical Equipment – Part 1-6: General Requirements

for Basic Safety and Essential Performance – Collateral Standard: Usability

• IEC 62366-1 Medical Devices – Part 1: Application of Usability Engineering to

Medical Devices

• IEC 62304 Medical Device Software – Software Life Cycle Processes

Power Requirements

Input: 100-240 VAC, 50/60 Hz, 0.18 A

Output: 5.0 VDC, 1.0 A

Note

The USB cable and charger are part of the Medical Electrical Equipment.

Radio Specications

Operating Frequency Range: 2.400 - 2.4835 GHz

Typical Output Power: 2.5 dBm

Maximum Output Power: 4.0 dBm

Modulation: GFSK, P/4 DQPSK, 8DQPSK

Temperature and Storage Information

Operation Charging Storage and Transport

Temperature: 41°F to 95°F

(+5°C to +35°C)

50°F to 104°F

(+10°C to +40°C)

-4°F to 140°F

(-20°C to +60°C)

Humidity: 15% to 85% RH

non-condensing

15% to 85% RH

non-condensing

15% to 85% RH

non-condensing

Atmospheric Pressure: 101.3 to 76.7 kPa

(0 - 7500 feet)

101.3 to 76.7 kPa

(0 - 7500 feet)

101.3 to 76.7 kPa

(0 - 7500 feet)

Additional Notices

• 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 trademarks

and trade names are those of their respective owners.

• The SmartSleep device data is encrypted at rest and in transit with strong industry

standard encryption.

• This device contains a FCC/IC certied Bluetooth radio module (located on the main board).

FCC ID: WAP2005 IC: 7922A-2005

• This Class B digital apparatus complies with Canadian ICES-003. HMN: SmartSleep. PMN

and HVIN: HH1600/02 and HH1600/03.

• Use of non-original manufacturer-approved accessories may violate your local RF

exposure guidelines and should be avoided.

• 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 o,

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).

19

— Increase the separation between the equipment and receiver.

— Connect the equipment into an outlet on a circuit dierent from that to which the

receiver is connected.

— Consult the dealer of the device for help.

• Any changes or modications made to the device that are not expressly approved by

Respironics may void the user’s authority to operate the equipment.

EMC Information

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions - This device is

intended for use in the electromagnetic environment specied below. The user of this

device should make sure it is used in such an environment.

Emissions TEsT ComplianCE ElECTromagnETiC EnvironmEnT - guidanCE

RF emissions

CISPR 11 Group 1

The 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 emissions

CISPR 11

Class B

The device is suitable for use in all

establishments, including domestic

establishments and those directly connected to

the public low-voltage charger network.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage uctuations/

Flicker emissions

IEC 61000-3-3

Complies

Emission of Radio

Frequency Energy

RTCA/DO-160G

Section 21

Category M This 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 specied below. The user of this

device should make sure it is used in such an environment.

immuniTy TEsT iEC 60601-1-2

TEsT lEvEl

ComplianCE lEvEl ElECTromagnETiC EnvironmEnT -

guidanCE

Electrostatic

Discharge

(ESD)

IEC 61000-4-2

±8kV contact

±2kV, ±4kV,

±8kV, & ±15kV air

±8kV contact

±2kV, ±4kV, ±8kV,

& ±15kV air

Floors should be wood, concrete or

ceramic tile. If oors are covered with

synthetic material, the relative humidity

should be at least 30 %

Electrical Fast

Transient/Burst

IEC 61000-4-4

±2kV for powers

supply lines

±1 kV for input-

output lines

±2KV for Power

Supply Lines

NA - Device does

not have user

I/O lines that are

longer than 3 m in

length.

Mains power quality should be that of a

typical home or hospital environment.

Surge

IEC 61000-4-5

±1 kV Line to

Line

±2 KV Line to

Ground

±1 kV Line to Line

NA - The device

is a Class II device

and does not

connect to earth

ground.

Mains power quality should be that of a

typical home or hospital environment.

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immuniTy TEsT iEC 60601-1-2

TEsT lEvEl

ComplianCE lEvEl ElECTromagnETiC EnvironmEnT -

guidanCE

Voltage

dips, short

interruptions and

voltage variations

on charger input

lines

IEC 61000-4-11

0% U

T

0.5 cycle,

45 deg inc

0% U

T

1 cycle

70% U

T

25 cycles

(30 cycles if US)

0% U

T

5 sec

0% U

T

0.5 cycle,

45 deg inc

0% U

T

1 cycle

70% U

T

25 cycles

(30 cycles if US)

0% U

T

5 sec

Mains power quality should be that of a

typical home or hospital environment.

If the user of the device required

continued operation during power

mains interruptions, it is recommended

that the device be powered from an

uninterruptible power supply or battery.

Power Frequency

(50/60 Hz)

Magnetic Field

IEC 61000-4-8

30 A/m 30 A/m Power frequency magnetic elds should

be at levels characteristic of a typical

location in a typical home or hospital

environment.

Note: U

T

is the AC 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 specied below. The user of this

device should make sure it is used in such an environment.

immuniTy TEsT iEC 60601-1-2 TEsT

lEvEl

ComplianCE

lEvEl

ElECTromagnETiC EnvironmEnT -

guidanCE

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3V

150 kHz to 80 MHz

6V in ISM & amateur

radio bands between

150 kHz and 80 MHz

10 V/m

80 MHz to 2.7 GHz

Up to 28 V/m in

telecommunication

bands as specied

in clause 8.10 of IEC

60601-1-2:2014

3 V

6 V

10 V/m

28 V/m

Portable and mobile RF communications

equipment (including peripherals such as

antenna cables and external antennas)

should be used no closer to any part of

the device, including cables specied by

the manufacturer, than the recommended

separation distance. Otherwise,

degradation of the performance of this

equipment could result.

Recommended separation distance:

Minimum 30 cm (12 inches)

Interference may occur in the vicinity of

equipment marked with the following

symbol:

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