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Advanced Brain Monitoring NIGHTSHIFT Manual de início rápido

Night Shift Features

Device Enclosure

Yellow LED

Green LED

Starting the Night

• Hold the On-Button down for 1-second.

• The LED indicator and vibration feedback patterns will confirm if there

is sufficient battery capacity to record and provide feedback for the

entire night:

Battery charge

LED indicator

sufficient for

pattern

3 nights

Green - 3 blinks

2 nights

Green - 2 blinks

1 night

Green - 1 blink

Yellow - 1 blink per

Needs charging

second

• When the device is powered on for a study, the LED indicator will blink

green for 5 min. After 5 min. the LED will become solid green.

• Place the device on the neck and go to sleep.

• Vibration feedback will not begin for the first 15 minutes to allow

adequate time to fall asleep.

• To turn the Device off, quick-press the On-Button and the Green LED

will turn off.

• Note: if the device has not been charged for a few weeks, the date and

time may be incorrect; connect the device to the portal and follow the

on-screen instructions to adjust the date and time.

Explanation of symbols:

5°C

Follow Instructions

Adults

Dispose

Keep Dry

Operating

for Use

Only

Properly

Temperature

IP22

0482

Limit Objects,

Charge

European

Type BF

Water Ingress

Between Uses

Conformity

Applied Part

Advanced Brain Monitoring, Inc.

2237 Faraday Ave, Suite 100, Carlsbad, CA, USA 92008

P 760.720.0099 | F 760.476.3620 | [email protected]

Manufacturer

European Represenative:

NS27-1005

MPS Medical Products Service GmbH,

Borngasse 20, 35619 Braunfels, Germany

For technical support, or to obtain a replacement neck strap, please contact your

Night Shift healthcare provider.

www.NightShiftTherapy.com

Charging the Night Shift:

• See Warnings associated with charging the device.

USB Port

• Remove the black USB cover and then insert the small cable

connector into the USB port of the device.

• Connect the large cable connector into a computer or

recommended USB wall charger.

• If the device does not appear to charge or hold a charge, try using

a new USB cable.

LED Indicators while Night Shift is charging

On-Button

Charging

error

Device

failure

Vibration

feedback

Cleaning the Night Shift:

3 times

The Night Shift should be cleaned regularly. When cleaned as described

below, the Night Shift can be reused on the same or different patients.

2 times

Strap: Detach the straps from the device. Wash each strap separately

1 time

by submerging in solution of 1 teaspoon (5 ml) of mild dish detergent

1 time every 5

(e.g. Dawn) per gallon (4 liters) of water. Agitate slightly for one to two

seconds

minutes. Rinse with clear warm tap water for one minute. Dry with a

clean paper towel.

Device: Wipe all surface areas of the device enclosure with a 70%

isopropyl alcohol wipe. All surface areas should remain wet for at

least 15 seconds. Using a new alcohol wipe, repeat the cleaning; allow

to remain wet for 15-seconds. If any visible soil remains, repeat as

needed. Allow to air-dry.

Using www.NightShiftTherapy.com:

Go to www.NightShiftTherapy.com and click the Portal link for

additional information and to register the device. Then you can:

• Generate and print daily, monthly, or annual reports to monitor

90%

106kPa

40°C

how often you're sleeping on your back, how well you are

15%

70kPa

Operating

sleeping, and how loudly you are snoring.

Humidity

Pressure

• Update date, time, and firmware on your device

Only

• Change the delay of delivery of positional feedback from

USA

Catalog

Serial

15-minutes after the device is powered on to 30-minutes.

Only

Number

The treatment efficacy of Night Shift was demonstrated in a study of 27 patients diagnosed with positional obstructive sleep apnea with a pre-treatment non-

supine apnea-hypopnea index < 20. The results showed:

Treatment outcome

AHI >50% decrease, % (n)

AHI >35% decrease, % (n)

Non-responder, % (n)

Green on – for up to three hours and LED will

turn off when charging is complete

Green and yellow on - check power supply and

cable connections

Yellow on - return the devices for servicing

Pre-treatment

>5 AHI <15

>15 AHI < 30

n = 11

n = 10

81.8 (9)

80.0 (8)

9.1 (1)

0.0 (0)

9.1 (1)

20.0 (2)

Indications for Use:

The Night Shift is indicated for prescription use for the treatment

of adult patients with positional obstructive sleep apnea with a

non-supine apnea-hypopnea index <20, and to reduce or alleviate

snoring. It records position, movement, and sound so that positional

changes in sleep quality and snoring can be assessed.

Warning: Do not wear the device while it is being charged. To

avoid permanent damage: a) charge with a medical IEC 60601.1

compliant wall charger (maximum 5 volts and 1.5 amps), b) avoid

use of rapid or fast wall chargers, and c) do not use USB cables

with exposed wires or bent pins.

Cautions:

• Night Shift users should NOT:

◦ have Cardiac Arrhythmia corrected with an artificial

pace-maker;

◦ have skin sensitivity or an open wound around their neck;

◦ have a neck size that is very small (less than 12 inches/30 cm) or

very large (greater than 22 inches/55 cm);

◦ sleep with their head in a near-upright position;

◦ suffer from tics or tremors of the head.

• You may initially feel more tired during the day if your sleep

is disrupted while you learn to respond to the vibrations.

• The measured signal will be influenced by a loud snoring bed

partner.

• Do not wear the Night Shift upside down – the reported sleep

time on your left and right sides will be reversed.

• Do not wear the strap too loose – position feedback will be

inaccurate if the device is NOT on the center of your neck.

• Do not wear the strap too tight – the strap may become detached

during the night.

• US Federal law restricts this device to sale by or on the order of a

physician.

• Dispose of the device that includes a Lithium Polymer battery

properly.

• To avoid damage not covered by warranty, keep the device dry

and clean, and out of reach of children and pets.

• Selection of an appropriate pillow for non-supine sleep

may reduce the occurrence of neck, shoulder, or back pain.

Discontinue use of the device and contact your physician or the

device manufacturer in case of any significant pain.

Warranty:

: Twenty-four (24) month warranty for assembly workmanship and

electronic components, twelve (12) month warranty for haptic motors and battery,

and six (6) month warranty for strap. Warranty does not cover damage attributed

to improper use by the customer. The warranty will be voided if an attempt is

made to open the enclosure or change the battery. The strap should be inspected

regularly for signs of deterioration due to normal wear and tear. It is recommended

that the strap be replaced every six months.

95%

Confidence Interval

AHI > 30

Total

n = 6

n = 27

100.0 (6)

85.2 (23)

71.8–98.6

0.0 (0)

3.7 (1)

-3.4–10.8

0.0 (0)

11.1 (3)

-0.8–23.0

US and International Patents, Patents-Pending