User's Manual

1-2 Introduction and Setup
Intended Use
Actiware / Actiware-CT is for use only in a clinical, research, or home care
provider setting.
Actiwatch-16/64
The Actiwatch
®
-16 or -64 is an ultra-compact, lightweight, wrist-worn activity
monitorthatcanbeusedtoanalyzecircadian rhythms, automatically collect
and score data for sleep parameters, and assess activity in any instance where
quantifiable analysis of physical motion is desirable. An Event Marker button is
availablethatallowsthesubject(patient)toentertime-stampedinformationand
events of significance.
Actiwatch-L
The Actiwatch
®
-L is an ultra-compact, lightweight, wrist-worn activity and
illuminancemonitorthatcanbeusedtoanalyzecircadianrhythms,automatically
collect and score data for sleep parameters, and assess activity in any instance
where quantifiable analysis of physical motion is desirable. The Actiwatch-L
does not have an Event Marker button.
Actiwatch-Score
The Actiwatch
®
-Score is a compact, lightweight, wrist-worn activity monitor
thatcanbeusedtoanalyzecircadianrhythms,automaticallycollectandanalyze
data for sleep parameters, and assess activity in any instance where quantifiable
analysis of physical motion is desirable. In addition, the Actiwatch-Score has
abuilt-inscorepadthatallowsthesubjecttosubjectivelyassignandentera
score from 0 to 15. The score pad can be used as a substitute or in addition to the
traditionalpatientdiaryusedinconjunctionwithactivitymonitoring.
This system is designed to conform to the following standards:
• IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements
for Safety
• IEC 60601-1-1 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety Requirements for
Medical Electrical Systems for Safety
• IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests
• IEC 60950-1 Information Technology Equipment - Part 1: General
Requirements for Safety
Indications for Use
Important! Actiwatch 16/64, -L, -Score are not intended for use as
diagnostic devices; they are intended for use as physiological parameter
recorders.