Use Instructions

Instructions for Use – NightOwl
®
Sensor – Healthcare Professional Page 21 of 24
8 Technical Specifications
8.1 Device and accessories
Signals and
samples rates
Photoplethysmography of wavelengths 660nm (red) and 880nm (infrared) at 50
Hz.
Accelerometry at 25 Hz.
Recording time
30 hours (3 x 10 hours)
Power supply
Rechargeable lithium-ion battery (graphite layered metal oxide LiNi
x
Mn
y
Co
z
O
2
),
3.7V, 60mAh, cycle life (80%) >500.
UN 38.3, UL 1642, IEC 62133 passed.
Weight
Sensor:
7
/
32
oz (6 grams)
Charging cradle:
13
/
16
oz (23 grams)
Adhesives
biocompatibility
Combination of polyethylene foam and polyester film with acrylic adhesive layer.
Biocompatibility testing performed according to ISO 10993.
Environmental
conditions
Operating temperature: 41°F to 104°F (5°C to 40°C)
Operating humidity: 10% to 90% non-condensing
Storage and transport temperature1: -13°F to 158°F (-25°C to 70°C)
Storage and transport humidity: 10% to 95% non-condensing
Operating air pressure: 700 hPa to 1,060 hPa
Interfaces
Sensor: Bluetooth® Low Energy 5 (downward compatible with 4.2 and 4.1)
Charging cradle: USB-C
Dimension
Sensor (length x width x height): 1
1
/
16
” x
3
/
4
” x
25
/
64
” (27 x 19 x 10 mm)
Charging cradle (l x w x h): 1
15
/
16
” x 1
1
/
2
” x
9
/
16
” (4.9 x 3.8 x 1.4 cm)
System
compatibility
The NightOwl® Sensor device has been validated to work within the intended use
and conform two-way interfacing requirements of the software devices in the
NightOwl® Diagnostic System (see 3.4 Connection to the NightOwl® Diagnostic
System) under the below condition(s):
1. Restrict sensor placement to overnight recordings on the finger
EMC
This device meets the requirements of the Electromagnetic Compatibility (EMC),
pursuant to IEC 60601-1-
2 for residential, commercial, and light industry
environments.
FCC
This equipment complies with FCC radiation exposure requirement.
The device can be used in portable exposure conditions without RF restriction.
1. 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.