Advanced Brain Monitoring NIGHTSHIFT User manual

The Night Shift strap
should be just tight
enough to prevent it from
sliding around the neck.
Two ngers on each side
should t between the
strap and the neck without
causing the magnets to release.
Re-fasten the
magnetic clasp and
tighten both sides of the
strap evenly, keeping the
enclosure centered on the
back of your neck and the
magnetic clasp centered
on the front.
Loop the strap back
and slide it through
the retention band. Pull the
strap through the band just
enough to hold it in place.
Repeat the process with
the other side.
Begin by feeding one end of the strap through one of
the slots on the side of the enclosure. The strap should
be fed through from the back to the front of the device, and
with the ridged side facing out.
NIGHTSHIFT
Sleep Positioner
TM
Intelligent, Interactive Monitoring
With the blue label
right-side up, center
the Night Shift on the back
of your neck. The blue
label must be facing away
from the neck and the On/
O button facing down.
Fitting the Night Shift: Step-by-Step
Use the numbers provided on the strap as a guide
to help even out each side.
15
15
With the straps
evened out, try
the Night Shift on again
and verify the t is still
comfortable and snug.
Once a good t is determined, excess length can be
trimmed o the ends of the strap. Leave at least 2
extra sizes in case you need to loosen the strap later. The
Night Shift is now properly t.
Unclasp the strap by bending at a 90° angle, like
snapping a stick. To avoid damage, do not pull apart.
Trimmed after 17Sized at 15
The Strap
a. Retention Band
b. Magnetic Clasp
Using the Night Shift:
• Prior to rst use, completely charge the device.
• Fit the strap so it is adjusted evenly on both sides. If
worn too tight, the magnetic clasp will detach during
the night. If worn too loose, incorrect positional
feedback will occur when not centered on the back of
your neck.
• Just after you turn the device on, it will provide
feedback to conrm sucient battery capacity to
record and provide feedback for at least eight hours.
Remember to recharge the battery at least once every
three days.
• When the Night Shift recognizes you are sleeping on
your back, it will vibrate with increasing intensity until
you change position.
• Night Shift records your position, sleep quality, and
snoring so you can print reports to monitor your
response to positional feedback.
Caution: Replace the strap immediately if the
clasps become demagnetized and do not retain
during the night.
www.nightshifttherapy.com
On/O button down
Blue label facing out
Night Shift is worn around the neck; it uses and measures
the eectiveness of vibration feedback to discourage
back-sleeping.
a
ab

Starting the Night
• Hold the On-Button down for 1-second.
• The LED indicator and vibration feedback patterns will conrm if there
is sucient battery capacity to record and provide feedback for the
entire night:
• 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 rst 15 minutes to allow
adequate time to fall asleep.
• To turn the Device o, quick-press the On-Button and the Green LED
will turn o.
• 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.
Night Shift Features
Battery charge
sucient for
LED indicator
pattern
Vibration
feedback
3 nights Green - 3 blinks 3 times
2 nights Green - 2 blinks 2 times
1 night Green - 1 blink 1 time
Needs charging Yellow - 1 blink per
second
1 time every 5
seconds
LED Indicators while Night Shift is charging
Charging Green on – for up to three hours and LED will
turn off when charging is complete
Charging
error
Green and yellow on - check power supply and
cable connections
Device
failure
Yellow on - return the devices for servicing
Green LED On-Button
USB Port
Yellow LED
Night Shift Features
Device Enclosure
Charging the Night Shift:
• See Warnings associated with charging the device.
• 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.
Cleaning the Night Shift:
TheNight Shift shouldbecleanedregularly. When cleaned asdescribed
below, the Night Shift can be reused on the same or dierent patients.
Strap: Detach the straps from the device. Wash each strap separately
by submerging in solution of 1 teaspoon (5 ml) of mild dish detergent
(e.g. Dawn) per gallon (4 liters) of water. Agitate slightly for one to two
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
how often you’re sleeping on your back, how well you are
sleeping, and how loudly you are snoring.
• Update date, time, and rmware on your device
• Change the delay of delivery of positional feedback from
15-minutes after the device is powered on to 30-minutes.
Serial
Number
Limit Objects,
Water Ingress
Catalog
Number
Keep Dry
Manufacturer
Type BF
Applied Part
USA
Only
Operating
Temperature
5°C
40°C
Operating
Humidity
15%
90%
Operating
Pressure
70kPa
106kPa
Adults
Only
Dispose
Properly
European
Conformity
Charge
Between Uses
Follow Instructions
for Use
IP22
Explanation of symbols:
European Represenative:
MPS Medical Products Service GmbH,
Borngasse 20, 35619 Braunfels, Germany
NS27-1005
For technical support, or to obtain a replacement neck strap, please contact your
Night Shift healthcare provider.
Cautions:
• Night Shift users should NOT:
◦have Cardiac Arrhythmia corrected with an articial
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;
◦suer 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 inuenced 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 signicant 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.
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.
www.NightShiftTherapy.com US and International Patents, Patents-Pending
© 2012-2019 Advanced Brain Monitoring, Inc. D27-8101-2 Rev 12
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.
0482
Advanced Brain Monitoring, Inc.
2237 Faraday Ave, Suite 100, Carlsbad, CA, USA 92008
P 760.720.0099 | F 760.476.3620 | [email protected]
Only
The treatment ecacy 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:
Pre-treatment 95%
Condence Interval
>5 AHI <15 >15 AHI < 30 AHI > 30 Total
Treatment outcome n = 11 n = 10 n = 6 n = 27
AHI >50% decrease, % (n)
AHI >35% decrease, % (n)
Non-responder, % (n)
81.8 (9)
9.1 (1)
9.1 (1)
80.0 (8)
0.0 (0)
20.0 (2)
100.0 (6)
0.0 (0)
0.0 (0)
85.2 (23)
3.7 (1)
11.1 (3)
71.8–98.6
-3.4–10.8
-0.8–23.0