Mini Mitter AWR1 ACTIREADER User Manual USERS MANUAL 3

Mini Mitter Co. Inc. ACTIREADER USERS MANUAL 3

Contents

USERS MANUAL 3

5015 B.U. Bowman Drive Buford, GA 30518 USA Voice: 770-831-8048 Fax: 770-831-8598
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FCC ID: JIAAWR1
IC: 6041A-AWR1
FCC Rule Part: 15.209
IC Radio Standards Specification: RSS-210
ACS Report Number 08-0085 - 15C
Manufacturer: Mini Mitter Company, Inc.
Model(s): ActiReader
Manual
(Part 3 of 3)
5-1
S
ECTION
5
ClINICAl TRIAlS
Actiware-CT (clinical trial) software is designed especially for customers who
are concerned about data security and compliance with 21 CFR Part 11. New
features have been included in the software that
 ●Restrictaccesstoonlyauthorizedusers.
 ●Embedelectronicsignaturesindatafiles.
 ●Securedatafileswithdigitalsignatures.
 ●Detectandreportunauthorizedaccess.
 ●Recordallchangestosubjectanddataproperties,aswellasanalysis
settings and results.
 ●Provideanaudittrailwindowtoviewversionsandelectronicsignatures.
Actiware-CT operates in the same manner as Actiware. Section 5 outlines
the security features in CT. Please refer to Getting Started in Section 2 for
information on using the software.
Note: Actiware-CT requires you to authenticate using your Windows or
Network username and password. Please contact your local administrator
with any issues or questions.
Note: Actiware-CT requires the Windows 2000 Professional or the
Windows XP Professional operating system.
5-2 Clinical Trials
Security Log on window
When you launch the Actiware-CT program, the Security Log on window will
appear. To access the program, you must log on with your User Name and
Password that you would normally use to access the Windows operating system.
Whenyouareaddinganewsubject,attemptingtosaveafile,ormakingany
changestoasubject,Actiwatchdata,oranalysis,Actiware-CTwillpromptyou
for your user name and password.
1. Enter User Name and Password.
2. Review the signature meaning.
3. Add any comments.
4. Click the Sign and Save button.
Authenticate
Sign and Save window
5. The file now carries your electronic signature and an Audit Trail is attached
to the data file. The meaning of the signature is also recorded in the data file.
5-3
The Audit Trail feature of Actiware 5.0 is designed to display all changes made
tosubjects,Actiwatchdataitemsandanalyses.Becausetherelationshipbetween
these items is hierarchical, the Audit Trail window will display all the parents of
any selected item.
If an analysis is selected for Audit Trail display, then the Audit Trail will show
allchangesforthatanalysis,it’sparentActiwatchdataitemandthesubjectthat
owns both of them.
If an Actiwatch data item is chosen for Audit Trail display, then that Actiwatch
dataitemandit’sparentsubjectwillbedisplayedintheAudit Trail window.
The picture below is the product of right-clicking on a saved analysis and
selecting the Audit Trail menu item. Each row in the left side of the window
represents either a record creation or a change to a record. In the screen shot
below,therearefiveaudittrailrecords:asubjectcreationandanedittothat
subject,anActiwatchdatarecordcreationandbothananalysiscreationandan
edittothesameanalysis.Notethattherowthatishighlightedisforasubject
creation and no value is listed in the right hand display for Prior Value as there is
no prior record.
Audit Trail
Results of right-clicking on a saved analysis and selecting the Audit Trail menu item.
5-4 Clinical Trials
When a highlighted row represents an edit, such as the second line below, then the
Prior Value column will contain the values before the edit.
Note that in the two previous pictures the buttons at the bottom of the screen
were not enabled. The most powerful feature of the Audit Trail window is the
ability to display all previous revisions of records. When an Actiwatch data
item is highlighted, the Show Graph button will be enabled. If you highlight
an analysis row, then all the buttons will be enabled and you can create an audit
version of an Actogram, statistics table or a data list.
Highlight the row to see prior and new values.
Audit Trail window provides the ability to view all previous revisions of the record.
5-5
If the analysis has been edited and saved, then multiple rows will be displayed,
such as the picture above. Highlighting the last row will reflect the most recent
version of the analysis. Pressing the Show Actogram button will display the
current Actogram in the normal display window except the title will be preceded
with the word Audit as shown below.
Note: Closing the Audit Trail window will close all Actograms, data lists
and statistics tables that were created by the Audit Trail window. To view
historical audit items, keep the Audit Trail window open and either move
it out of the way or minimize it.
To view a past revision of the analysis, highlight the desired row and click the
Show Actogram button etc. Only one audit Actogram can exist. If an audit
Actogram is open and a new audit Actogram is created, the open Actogram will
be closed and the new one will replace it. The same holds true for statistics tables
and data lists. Items created from the Audit Trail window cannot be edited.
Audit Actogram window
5-6 Clinical Trials
Introduction to Electronic Signatures
To use Actiware-CT you will be required to log on. The log on procedure is
part of the security Actiware-CT offers to protect the data that is acquired from
Actiwatch.
Each time a record is created or revised, the user must sign with their username
and password and an electronic signature is created and attached to the record.
The electronic signature in Actiware-CT is considered to be the equivalent of a
handwritten signature executed on paper. When the signature process has been
completed, the resulting secure record consists of three parts:
• Data
• Public Key
• Digital Signature
Upon signing and saving the data record, a secret, private key is used to encrypt
a special set of characters that represent the data. This is called a hash, or digest
of the data. The result of this encryption process is the digital signature. The
data in the record is saved along with the digital signature and a public key. The
public key is used to decrypt the digital signature when the record is read. When
the record is read and the signature verified, the result of decrypting the digital
signature (the original hash) is compared to a hash computed from the contents
read from the record. When the two hash results are found to be identical, this
means the signature is verified, and the file has not been altered or corrupted
(including the signature elements that identify the signer: user name and full
name, as well as the public key and digital signature).
Actiware-CT Provision Result
Authentication The identity of the signer can be determined by
anyone.
Integrity Any alteration can be detected.
Non-repudiation Verifies the origin or delivery of data. Protects
the signer because the recipient cannot change
the file. Protects the recipient because the signer
cannot deny they sent it.
Because integrity is assured and authentication and non-repudiation are
provided, the digital signature/public key/user name/full name inserted in every
digitally signed output file can be considered the legally binding equivalent of a
traditional handwritten signature.
Actiware-CT software does not provide the ability to change the contents of an
electronic record that has already been created. Instead, any change to a record
(subject,Actiwatchdata,oranalysis)isrecordedasanewrevisionwithanew
digital signature. Any attempt to change a data record manually will make the
file unusable by the software. Also, each time an electronic record is created, the
user must sign the document, and the user’s user name and full name, along with
date and time of signing are embedded in the record.
Note: Each revision to the data le is preserved and signed/hashed
separately.
5-7
The database is validated and automatically backed-up when
• Opening a database.
• Retrieving data from an Actiwatch.
• Closing a database and exiting Actiware-CT.
This means that each record’s digital signature is verified and each revision
history is checked. Hence, any attempt to delete or change data stored in an
Actiware database is detected, making the database inaccessible.
Database Validation and Back-up
Export Files
Export files created by Actiware, both individual and combined export files, are
signed with an electronic signature, including a digital signature. We do this to
assist our customers in complying with 21 CFR Part 11.
For assistance in verifying this signature for your validation purposes, please
contact technical support.
5-8 Clinical Trials
A-1
AppENdIx
A
S
lEEP/
W
AKE
A
NAlYSIS
Actiware scores all epochs as either sleep or wake. Whether a particular epoch
is scored as wake is determined by comparing activity counts for the epoch in
question and those immediately surrounding it, to a threshold value set by the
researcher. If the number of counts exceeds the threshold, the epoch is scored as
wake. If it falls below, or is equal to, the threshold, the epoch is scored as sleep.
Sleep = TotalActivityCounts≤Wake Threshold Value
Wake = Total Activity Counts > Wake Threshold Value
Calculating Total Activity Counts
Actiware calculates total activity counts based on the sampling epoch. Below are
four diagrams showing how this scoring calculation is done.
15-second
sampling
epochs
A-2 Sleep/Wake Analysis
30-second
sampling
epochs
1-minute
sampling
epochs
2-minute
sampling
epochs
A-3
For instance, assume a 1-minute sampling epoch and the following activity
values on/and surrounding the time 12:00.
Time Corresponding
Activity Data
11:58 100
11:59 42
12:00 20
12:01 13
12:02 67
The total activity value for the 12:00 epoch would be:
100 * (1/25) + 42 * (1/5) +20 + 13 * (1/5) + 67 * (1/25) = 37.68.
If this value is less than or equal to the wake threshold value (next paragraph)
then the epoch would be scored as sleep.
Wake
Threshold
Values
The total number of activity counts calculated above is compared to the wake
threshold value selected by the researcher. These thresholds are listed in the table
below.
Wake Threshold Selection Wake Threshold Value*
Low 20
Medium 40
High 80
Automatic Computed automatically based on activity
data
Custom User-selectable value
*The Automatic Wake Threshold Value calculation is this:
1. Sum the activity counts for all epochs of the data set;
2. Count the number of epochs scored as MOBILE for the data set (see below
for definition of MOBILE);
3. Compute the MOBILE TIME (number of epochs scored as MOBILE from
step 2 multiplied by the Epoch Length) in minutes;
4. Compute the Auto Wake Threshold = ( (sum of activity counts from step 1)
divided by (MOBILE TIME from step 3) ) multiplied by 0.88888
Definition of MOBILE:
An epoch is scored as MOBILE if the number of activity counts recorded in that
epoch is greater than or equal to the epoch length in 15-second intervals. For
example, there are four 15-second intervals for a 1-minute epoch length; hence,
the activity value in an epoch would have to be greater than or equal to four to be
scored as MOBILE.
A-4 Sleep/Wake Analysis
B-1
AppENdIx
B
S
TATISTIC
D
EFINITIONS
Statistic Definitions
(In the order, left to right, in which they appear in the statistics table window
when all are selected.)
Start Time
The time at the start of the given Rest, Active, Sleep, Custom, or Daily Interval
(the start of the first epoch in the given interval).
End Time
The time at the end of the given Rest, Active, Sleep, Custom, or Daily Interval
(the end of the last epoch in the given interval).
Interval Duration
The time elapsed between the Start Time and the End Time of the given interval,
in minutes.
Total Activity
The sum of all valid physical activity counts [see Total Invalid Time, below] for
all epochs from the Start Time to the End Time of the given interval.
Average Activity Per Minute
The average of all valid physical activity counts for all epochs from the Start
Time to the End Time of the given interval divided by the Epoch Length in
minutes.
Average Activity Per Epoch
The average of all valid physical activity counts for all epochs from the Start
Time to the End Time of the given interval.
Standard Deviation of Activity
The standard deviation of all valid physical activity counts for all epochs from
the Start Time to the End Time of the given interval. (The standard deviation is
computed with (n – 1) rather than (n) in the denominator of the variance.)
Maximum Activity
The largest of any valid physical activity count for all epochs from the Start Time
to the End Time of the given interval.
B-2 Statistic Definitions
Total Invalid Time (Activity)
(The total number of epochs between the Start Time and the End Time of the
given interval in which the physical activity count was found to exceed the
maximum possible value from a properly functioning Actiwatch [i.e., invalid data
due to rare hardware error, communication error, or data corruption] plus the total
number of epochs with valid physical activity counts manually excluded from
the data set by the practitioner using Actiware) software multiplied by the Epoch
Length in minutes (so the Total Invalid Time is in minutes).
Percent Invalid (Activity)
a) The percentage of Total Invalid Time (Activity) [see above] to the Interval
Duration [see above]. b) (Total Invalid Time (Activity) divided by Interval
Duration) multiplied by 100.
Total Invalid Time (Sleep/Wake)
(The total number of epochs between the Start Time and the End Time of the
given interval for which the sleep/wake scoring algorithm did not have enough
data to determine a SLEEP or WAKE score) multiplied by the Epoch Length in
minutes (so the Total Invalid Time is in minutes). Note: The insufficient data
condition can be caused by invalid or manually excluded physical activity data
at the epoch, and/or immediately before the epoch, and/or immediately after the
epoch – how much before and after being a function of the Epoch Length.
Percent Invalid (Sleep/Wake)
a) The percentage of Total Invalid Time (Sleep/Wake) [see above] to the Interval
Duration [see above]. b) (Total Invalid Time (Sleep/Wake) divided by Interval
Duration) multiplied by 100.
Sleep Onset Latency
a) The time elapsed between the Start Time of a given Rest Interval and the
following Sleep Start Time, in minutes. b) The time required for the onset
of sleep after first attempting to get to sleep (i.e, from the “lights out” time).
Calculated using the analysis setting made on Tools > Options > Analysis.
Snooze Time
a) The time elapsed between Sleep End Time and the End Time of a given Rest
Interval, in minutes. b) The time elapsed between the end of sleep and the time
lightsareswitchedonorthesubjectgetsoutofbed.
Sleep Efficiency
a) The percentage of Scored Total Sleep Time [see below] to (Interval Duration
[see above] minus Total Invalid Time (Sleep/Wake)), for the given Rest Interval.
b) (Scored Total Sleep Time divided by (Interval Duration minus Total Invalid
Time (Sleep/Wake)) of the given Rest Interval) multiplied by 100.
Wake After Sleep Onset (WASO)
The total number of epochs between the Start Time and the End Time of the
given Sleep Interval scored as WAKE by Actiware software (or manually set as
WAKE by the practitioner using Actiware software) multiplied by the Epoch
Length in minutes (so the Wake After Sleep Onset is in minutes). Note: Wake
After Sleep Onset is identical to Scored Total Wake Time [see below] when the
given interval is a Sleep Interval.
B-3
Scored Total Wake Time
(The total number of epochs between the Start Time and the End Time of the
given interval scored as WAKE by Actiware software [or manually set as WAKE
by the practitioner using Actiware software]) multiplied by the Epoch Length
in minutes (so the Scored Total Wake Time is in minutes). Note: In order to be
scoreable as SLEEP or WAKE, an epoch must have a valid physical activity
count [see Total Invalid Time (Sleep/Wake), above], and in addition there must
be a sufficient number of epochs before and after the epoch being scored that also
have valid physical activity counts.
Percent Wake
a) The percentage of Scored Total Wake Time to (Interval Duration minus Total
Invalid Time (Sleep/Wake)), for the given interval. b) (Scored Total Wake Time
divided by (Interval Duration minus Total Invalid Time (Sleep/Wake)) multiplied
by 100.
Number of Wake Bouts
The total number of continuous blocks, one or more epochs in duration, with each
epoch of each block scored as WAKE, between the Start Time and the End Time
of the given interval.
Average Duration of Wake Bouts
The Scored Total Wake Time [see above] divided by the Number of Wake Bouts
[see above], for the given interval.
Scored Total Sleep Time
(The total number of epochs between the Start Time and the End Time of the
given interval scored as SLEEP by Actiware software [or manually set as SLEEP
by the practitioner using Actiware software]) multiplied by the Epoch Length
in minutes (so the Scored Total Sleep Time is in minutes). Note: In order to be
scoreable as SLEEP or WAKE, an epoch must have a valid physical activity
count [see Total Invalid Time (Sleep/Wake), above], and in addition there must
be a sufficient number of epochs before and after the epoch being scored that also
have valid physical activity counts.
Percent Sleep
a) The percentage of Scored Total Sleep Time to (Interval Duration minus Total
Invalid Time (Sleep/Wake)), for the given interval. b) (Scored Total Sleep Time
divided by (Interval Duration minus Total Invalid Time (Sleep/Wake)) multiplied
by 100.
Number of Sleep Bouts
The total number of continuous blocks, one or more epochs in duration, with each
epoch of each block scored as SLEEP, between the Start Time and the End Time
of the given interval.
Average Duration of Sleep Bouts
The Scored Total Sleep Time [see above] divided by the Number of Sleep Bouts
[see above], for the given interval.
Scored Total Immobile Time
(The total number of epochs between the Start Time and the End Time of the
given interval scored as IMMOBILE by Actiware software) multiplied by the
Epoch Length in minutes (so the Scored Total Immobile Time is in minutes)
Note: In order to be scoreable as IMMOBILE or MOBILE, an epoch must have a
valid physical activity count [see Total Invalid Time (Activity), above].
B-4 Statistic Definitions
Percent Immobile
a) The percentage of Scored Total Immobile Time to (Interval Duration minus
Total Invalid Time (Activity)), for the given interval. b) (Scored Total Immobile
Time divided by (Interval Duration minus Total Invalid Time (Activity))
multiplied by 100.
Number of Immobile Bouts
The total number of continuous blocks, one or more epochs in duration, with
each epoch of each block scored as IMMOBILE, between the Start Time and the
End Time of the given interval.
Average Duration of Immobile Bouts
The Scored Total Immobile Time [see above] divided by the Number of
Immobile Bouts [see above], for the given interval.
Scored Total Mobile Time
(The total number of epochs between the Start Time and the End Time of the
given interval scored as MOBILE by Actiware software) multiplied by the Epoch
Length in minutes (so the Scored Total Mobile Time is in minutes). Note: In
order to be scoreable as IMMOBILE or MOBILE, an epoch must have a valid
physical activity count [see Total Invalid Time (Activity), above].
Percent Mobile
a) The percentage of Scored Total Mobile Time to (Interval Duration minus Total
Invalid Time (Activity)), for the given interval. b) (Scored Total Mobile Time
divided by (Interval Duration minus Total Invalid Time (Activity)) multiplied by
100.
Number of Mobile Bouts
The total number of continuous blocks, one or more epochs in duration, with
each epoch of each block scored as MOBILE, between the Start Time and the
End Time of the given interval.
Average Duration of Mobile Bouts
The Scored Total Mobile Time [see above] divided by the Number of Mobile
Bouts [see above], for the given interval.
Number of Immobile Bouts 1 Minute in Duration
The total number of continuous blocks 4 epochs in duration if Epoch Length = 15
seconds, 2 epochs in duration if Epoch Length = 30 seconds, 1 epoch in duration
if Epoch Length = 60 seconds (not applicable if Epoch Length is greater than
60 seconds), with each epoch of each block scored as IMMOBILE, between the
Start Time and the End Time of the given interval.
Percentage of Number of Immobile Bouts 1 minute in duration to the Number
of Immobile Bouts
a) The percentage of Number of Immobile Bouts 1 Minute in Duration to the
Number of Immobile Bouts [see above], for the given interval. b) (Number of
Immobile Bouts 1 Minute in Duration divided by Number of Immobile Bouts)
multiplied by 100.
Fragmentation Index
The sum of Percent Mobile [see above] and Percent Immobile Bouts Less Than
1-Minute Duration to the Number of Immobile Bouts, for the given interval. Also
known as the Index of Restlessness or Movement and Framentation Index.
B-5
Total Illuminance Exposure
(The sum of all valid illuminance data, in Lux, from an Actiwatch-L [see Total
Invalid Time (Illuminance), below] for all epochs from the Start Time to the End
Time of the given interval) multiplied by the Epoch Length in minutes (so the
Total Illuminance Exposure is in Lux-minutes).
Average Illuminance
The average of all valid illuminance data for all epochs from the Start Time to the
End Time of the given interval.
Standard Deviation of Illuminance
The standard deviation of all valid illuminance data for all epochs from the Start
Time to the End Time of the given interval. (The standard deviation is computed
with (n – 1) rather than (n) in the denominator of the variance.)
Maximum Illuminance
The datum of highest value (greatest average intensity of illumination during
an epoch) from the set of all valid illuminance data for all epochs from the Start
Time to the End Time of the given interval, i.e. the peak value in the data set
– the highest intensity of illumination the Actiwatch-L was exposed to during the
interval.
Time Above Illuminance Threshold
a) (The total number of epochs between the Start Time and the End Time of the
given interval with valid illuminance data greater than the given Illuminance
Threshold) multiplied by the Epoch Length in minutes (so the Time Above
Illuminance Threshold is in minutes). b) The total accumulation of time,
in minutes, during which the Actiwatch-L was exposed to an intensity of
illumination above the given Illuminance Threshold.
Total Invalid Time (Illuminance)
The total number of epochs between the Start Time and the End Time of the
given interval in which the illuminance datum was found to exceed the maximum
possible value from a properly functioning Actiwatch-L [i.e., invalid data due
to rare hardware fault, communication error, or data corruption] plus the total
number of epochs with valid illuminance data manually excluded from the data
set by the practitioner using Actiware software) multiplied by the Epoch Length
in minutes (so the Total Invalid Time is in minutes).
Percent Invalid (Illuminance)
a) The percentage of Total Invalid Time (Illuminance) [see above] to the Interval
Duration [see above]. b) (Total Invalid Time (Illuminance) divided by Interval
Duration) multiplied by 100.
Total Number of Scores
The Number of Manual Scores [see below] plus the Number of Scheduled Scores
[seebelow]enteredbythesubjectwhilewearingActiwatch-Score, and not
manually excluded later by the practitioner using Actiware software, from the
Start Time to the End Time of the given interval.
Number of Manual Scores
ThenumberofManualScoresenteredbythesubjectwhilewearingActiwatch-
Score, and not manually excluded later by the practitioner using Actiware
software, from the Start Time to the End Time of the given interval.
B-6 Statistic Definitions
Number of Scheduled Scores
ThenumberofScheduledScoresenteredbythesubjectwhilewearing
Actiwatch-Score, and not manually excluded later by the practitioner using
Actiware software, from the Start Time to the End Time of the given interval.
Number of No Responses
The number of No Responses to Scheduled Scores (that are not manually
excluded by the practitioner using Actiware software), from the Start Time to the
End Time of the given interval.
Average Score
(The sum of all Manual Score Values [that are not manually excluded] plus the
sum of all Scheduled Score Values [that are not manually excluded]) divided by
the Total Number of Scores [see above], for all epochs from the Start Time to the
End Time of the given interval.
Average Manual Score
The sum of all Manual Score Values [that are not manually excluded] divided by
the Number of Manual Scores [see above], for all epochs from the Start Time to
the End Time of the given interval.
Average Scheduled Score
The sum of all Scheduled Score Values [that are not manually excluded] divided
by the Number of Scheduled Scores [see above], for all epochs from the Start
Time to the End Time of the given interval.
Standard Deviation of All Scores
The standard deviation of all Manual Score Values [that are not manually
excluded] together with all Scheduled Score Values [that are not manually
excluded] for all epochs from the Start Time to the End Time of the given
interval. (The standard deviation is computed with (n – 1) rather than (n) in the
denominator of the variance.)
Standard Deviation of Manual Scores
The standard deviation of all Manual Score Values [that are not manually
excluded] for all epochs from the Start Time to the End Time of the given
interval. (The standard deviation is computed with (n – 1) rather than (n) in the
denominator of the variance.)
Standard Deviation of Scheduled Scores
The standard deviation of all Scheduled Score Values [that are not manually
excluded] for all epochs from the Start Time to the End Time of the given
interval. (The standard deviation is computed with (n – 1) rather than (n) in the
denominator of the variance.)
C-1
AppENdIx
C
A
CTIWATCH
H
ARDWARE
All communication with Actiwatch is accomplished using an ActiReader that
is connected to a computer via an RS-232 Serial Port. This connection to the
computer supplies power and communication instructions. Settings made prior to
the start of data collection, as well as all data values, are communicated through
this device. The Actiwatch and ActiReader communicate using short range radio
telemetry. Readers are not “unit specific,” i.e., any Actiwatch may communicate
with any ActiReader or Actiwatch Reader.
There are four models of Actiwatch currently available:
Actiwatch®-64
Actiwatch-64 contains 64 KB of on-board memory. Chronobiological studies
can be conducted over several weeks because intervals longer than five
minutes may be selected. An eventmarkerbuttonallowssubjectstomark
times at which important events occur.
Actiwatch®-16
Similar to the Actiwatch-64, but Actiwatch-16 has 16 KB of memory.
Actiwatch®-L
Actiwatch-L measures activity and ambient light exposure (illuminance).
Actiwatch-L does not have an event marker button.
Actiwatch®-Score
Actiwatch-Scoremeasuresactivityandsubjectiveweightingofspecifictimes
or events.
C-2 Actiwatch Hardware
Actiwatch
Details
Accelerometer
The shape of the accelerometer makes it most sensitive to motion changes
in certain orientations. However, it is an omnidirectional sensor, resulting
in sensitivity to motion changes in all directions. The Actiwatch stores an
integration of movement (including directional aspects) as activity “counts”.
Thesamplingfrequencyis32Hz.
Accelerometer orientation
Sensor Calibration and Reproducibility
EachActiwatchhasbeenprogrammedwithacalibrationcoefficienttonormalize
data between watches. During calibration at the factory, all Actiwatch devices are
normalizedtoremovemost,ifnotallvariationbetweendevices.Regardlessof
thisfeature,weemphasizethatrelativelevelsofactivitywithinadataset,oras
measured by the same device, should be used for drawing inference rather than
absolute values between units. This is due to the great variation in mounting the
device.
Note: To obtain the most repeatable results, it is important to develop a
standardized mounting and positioning protocol.
Time Keeping
The computer clock sets the Actiwatch start time. Within the device a crystal
oscillator keeps elapsed time. When a sampling epoch is chosen, Actiwatch waits
a specific number of oscillations before storing the number of activity counts.
This also applies to delayed starting times. The time-keeping circuitry does not
initiate until the device has been removed from the reader.
C-3
Note: For Actiwatch 16/64 (SN prior to V90xxxx) and Actiwatch-L, the
time-keeping function of the device will not start while on the ActiReader.
These Actiwatch devices cannot keep time while retrieving data. The
Actiwatch Score and Actiwatch 16/64 (SN V90xxxx and later) may
keep time while on the ActiReader for short durations. You should still
recongure the watch after retrieving data.
Telemetric Communications Link
Actiwatch requires no external communications port for configuration or data
retrieval. Communication between Actiwatch and ActiReader is established via a
wireless link.
Water Proof
Actiwatch-16, 64, and Actiwatch-L devices are waterproof to IEC Standard
60529 IPX7. They are water tight to a depth of 1 meter for 30 minutes. These
devices will tolerate normal daily experiences such as shower, spa (hot tub),
swimming, skiing, rain, household chores, etc. Actiwatch-Score is drip-tight
to IEC Standard 60529 IPX2. It is resistant to dripping and light splashing of
liquids.
CAUTION! Prolonged submersion or exposure exceeding the above limits
may cause damage to the device.
CAUTION! When replacing the battery, it is very important that the
rubber O-ring in the battery compartment also be changed. The back
mounting panel should be rmly screwed in place to achieve a waterproof
seal. The waterproof seals of all Actiwatch devices are checked before
leaving the factory. To preserve this integrity, it is imperative you follow
the procedures in the Change Battery Wizard.
C-4 Actiwatch Hardware
Standard Wrist Bands
Standard Actiwatch wrist bands are washable and disposable. Extra bands and
batteries are available from Mini Mitter. Bands may also be interconnected if
the device is to be worn on locations other than the wrist. Longer bands for use
around the ankle are also available from Mini Mitter, and a soft, nylon band with
hook and loop fastener. Other means to attach Actiwatch may be used as long as
the protocols of mounting and positioning are followed.
Marker Button
Actiwatch-16, Actiwatch-64, and Actiwatch-Score models are equipped with a
marker switch on the device’s front panel. When depressed this button provides
tacticfeedbackalertingthesubjecttoasuccessfulmarkingofthedateandtime.
A light sensor in Actiwatch-L replaces the marker button.
Animal Case
Both Actiwatch-16 and Actiwatch-64 can be fitted in the Actiwatch animal case.
This case protects Actiwatch from water, soil, shock, and gnawing. It does not
affect performance.
Actiwatch-L
The specifications and functions in this manual for Actiwatch-L pertain to those
devices manufactured on or after July 1, 1999. These devices are easy to identify
as they have a serial number that begins with the letter “P.” Actiwatch-L devices
manufactured before July 1, 1999 have serial numbers beginning with “L.” These
previous devices have different functional specifications and are not supported
by Actiware version 5 or later. If you have questions, contact Mini Mitter for
additional information.
Actiwatch-Score
Thisdeviceprovidesthemeanstosubjectively“score”bytwomethods.
• Auditory/flashing-display from device
 AnalarmsoundsandtheLEDdisplayflashesalertingtheusertosubjectively
weight the event. The annunciation times are chosen during the device
 configuration.Anexampleofthisusewouldbearequestoftheusertojudge
the level of sleepiness every half-hour during a long task.
• Arbitrary input from user
 Inthis“manual”modetheuserinputsalevelofsubjectiveweighting
commensurate with the event. An example of this use might be a level of
recurring headache pain through the day, or perhaps a level of depression.
Actiwatch-Score devices with serial numbers beginning with “N” are not
supported by Actiware version 5 or later. If you have questions, contact Mini
Mitter for additional information.
C-5
Actiwatch-L and Actiware combine hardware and software functions to
determinelight(illuminance)exposureforsubjectsmonitoredwiththe
Actiwatch-L. Actiware will configure and retrieve data from an Actiwatch-L.
When light (illuminance) data are available, Actiware will display them in the
Actogram, Graph, Data List, and Statistics Table.
Actiwatch-L does not include a marker button. It is replaced with a light sensor.
Hence no marker data are available in the analysis windows for Actiwatch-L
devices.
ACTIWATCH-L
Parameter Value Condition or Unit
Peak spectral sensitivity 580 nm (nanometers)
Wavelength window 330 to 720 nm
Minimum illuminance sensitivity 0.1 lux
Maximum illuminance sensitivity 150,000 lux
Linearity 2% Typical from 0.1 to 150,000 lux
Uncertainty <10% Typical from 400 to 800 nm
Resolution 2% of lux value Typical
Temperature variation of spectral sensitivity <0.1% From 400 to 800 nm
Angular response ±50 degrees to 1/2 power point
Active area 5.16 mm2
Light Sensor Type
Actiwatch-L has a photodiode for sensing incoming light (illuminance). This
optical sensor has a spectral sensitivity approximating that of the human eye.
Light Sensor Performance
The light-measuring performance of the AW-L is as follows:
C-6 Actiwatch Hardware
Recommended Calibration
We recommend factory calibration of Actiwatch-L every 12 months. Contact
Mini Mitter Technical Support for information.
Inuences
There are various factors that may influence the light (illuminance) data collected
by Actiwatch-L. The most likely to occur are as follows.
Sensor positioning
The angle at which light impacts Actiwatch-L can result in variations in readings.
This is true of all light sensing devices. It is important that researchers develop
astandardizedlocationonthesubjecttoenableActiwatch-Ltominimizethis
variable.
Condition of the lens
Light (illuminance) measurement varies greatly with a buildup of materials on
the lens. It is important to check for dirt, moisture, and other obscuring debris
prior to initiating data collection. Keeping the device clean will help avoid this
problem. Clean as you would eyeglasses, with a soft cloth moistened with water.
Inadvertently covering Actiwatch-L
The light sensor may inadvertently be covered by clothing or other items. The
unit may be detached from the band and used on a visor or other piece of clothing
tominimizethispossibility.Analysisofdatashouldalwaystakethesevariables
into account.
Illuminance Data
Illuminance data (“light data”) retrieved from Actiwatch-L are stored in the
Actiware database along with activity data. Illuminance data are expressed in the
SI (System International) unit of lux (see “Definitions for Actiwatch-L” on the
following page).
Light Analysis is integrated seamlessly into Actiware. Instead of having a
separatewindowforanalyzingilluminancedata,theActogram, Graph, Data List,
and Statistics Table can be used for light analysis.
Actiwatch-L Actogram Data
C-7
Illuminance data are displayed in the Actogram as an orange line graph
superimposed over the activity data. You can use the Actogram View toolbar to
adjusttheIlluminance Scale, the vertical height of the illuminance data.
Illuminance data are also shown in Graph as an orange line.
Per epoch Illuminance data can be seen in the Data List along with activity data,
and can be exported along with activity data and per epoch sleep analysis results.
The Illuminance column can be shown or hidden in the Data List or Export files
byadjustingsettingsintheTools > Options > Data List window.
To select illuminance statistics, use Tools > Options window, Statistics tab.
The selected illuminance statistics will be included for Rest, Active, Daily, and
Custom Intervals. This will cause these statistics to be included for Rest, Active,
Daily,andCustomIntervals.YoucancreateCustomIntervalsforanalyzing
periods of interest, without using or affecting sleep statistics. See Advanced
Usage, section 4 for help in creating intervals.
Definitions for Actiwatch-L
ThefollowingdefinitionsarespecificwhenanalyzingdatafromanActiwatch-L.
Illuminance
Intensity of illumination. The luminous flux incident on a given surface per unit
area. Measured in lux.
Luminous Flux
Rate of flow of radiant energy as evaluated by the luminous sensation that it
produces. The luminous flux is obtained from the radiant flux of the source
corrected according to the effect it has on the observer, i.e. according to the
spectral sensitivity of the receptor.
Lux
SI (System International) unit of illuminance. One lumen uniformly incident on
an area of one square meter.
Light
The agent that causes a visual sensation when it falls on the retina of the eye (a
narrow section of the electromagnetic spectrum).
C-8 Actiwatch Hardware
Actiwatch-Score is an activity monitor with an annunciator, an event marker
button, and an illuminated numerical display. It allows the application of
subjectivelevelstotimestampedevents.ThefrontpanelofActiwatch-Scorehas
a marker button, 2-digit, 7-segment direct-read LEDs, and an annunciator.
Actiwatch-Score activity data is identical to other Actiwatch models. Actiwatch-
Score is unique in that the marker button allows the user to “score” an event.
ACTIWATCH-SCORE
Actiwatch-Score main functions
Actiwatch-Score Setup
For all Actiwatch devices, the Actiwatch-Score is configured using the Configure
ActiwatchWizard.Thiswizardprovidesthemeanstoprogramthescoringrange
(any range from 0 through 15), and schedule audible alarms. Audible alarms are
usedtoremindthepatienttoenterasubjectivescorevalueintotheActiwatch.
Once the data have been downloading into Actiware using the Retrieve Data
fromActiwatchwizard,youcananalyzeyourScoreData.
Score Analysis
Score Analysis is integrated seamlessly into Actiware. Instead of having a
separatewindowforanalyzingscoredata,theActogram, Graph, Data List, and
Statistics Table can be used for score analysis.
C-9
Actiwatch-Score Actogram Data
There are three types of Score data.
Scheduled Scores
These are score values where the patient responded to the scheduled alarm you
programmed. These scores appear as magenta lines on the display.
Manual Scores
These scores were entered manually, without an alarm. They appear as green
lines on the display.
No Response
When the patient does not respond to a scheduled alarm, this is represented by a
small red triangle.
C-10 Actiwatch Hardware
Only one score can be recorded per epoch.
The score value and score type can be seen by placing your mouse over the
triangle at the top of the score value in the Actogram.
Per epoch score data can be seen in the Data List along with activity data, and
can be exported along with activity data and per epoch sleep analysis results. In
addition, a Marker/Score List is provided that includes only the score data. The
Score and Score Type columns can be shown or hidden in the Data List or Export
filesbyadjustingsettingsintheTools > Options > Data List window.
To generate statistics based on score data, use the Tools > Options window,
Statistics tab to include Score Statistics. This will cause these statistics to be
included for Rest, Active, Daily, and Custom Intervals. You can create Custom
Intervalsforanalyzingperiodsofinterest,withoutusingoraffectingsleep
statistics. See Getting Started in section 2 for help in creating custom intervals.
The annunciator is a miniature horn that generates a “chirp” form of audible
announcement. The annunciator sound exits through the side of the case. The
annunicator is water-resistant as well as the case.
Turning off the annunciator
1. Hold the marker button down 3 seconds.
2. The LED will display OF to verify the annunciator is off.
Turning on the annunciator
1. Hold the marker button down for 3 seconds.
2. The LED will display On to verify the annunciator is on.
Annunciator
Note: After setup, the annunciator is reset to On.
The marker button is a switch that is used to respond to an audible event and
enter a score to “weight” the event. It can also be used to turn the annunciator on
and off.
Marker
Button
C-11
Scheduled Events
During a scheduled event, if the marker button is pressed the annunciator
will silence, and the score range minimum value chosen during setup
will replace the two dashes. Each subsequent press of the marker will
increment the display until it reaches the score range maximum value
chosen during setup. If the marker button is pressed one more time, the
display will begin again at the minimum value.
Manual Event
During a “manual” event, i.e., when no alarm is sounded but a marker is
entered, the display will show two dashes. If the annunciator is enabled,
Actiwatch-Score will beep once per second for 10 seconds, or until the
event is scored.
Note: Once the marker button is pressed, released, and pressed
again and held, the LED will increment once per second.
LED Display The display is a 2-digit, 7-segment LED. In addition to displaying the
score (event weighting), there are other functions as well.
• When an event is to be scored, the annunciator will beep once per
second for 10 seconds. If the annunciator is disabled, only the LED
will activate.
• The display will show the annunciator status (on or off) after the
marker button is pressed and held for 3 seconds (refer to
Annunciator on preceding page).
Note: AW-Score will not acquire activity data during the brief time
the LEDs are lit, such as when setting score values.
C-12 Actiwatch Hardware
Battery Life The battery life for Actiwatch-Score is primarily affected by:
• The number of score entries (whether prompted by an alarm or not)
• Time taken to enter a score (when the LEDs are lit) The following table
is the battery life in days as a function of the average scores per day, and the
average score entry time (approximate):
Time taken to enter score
10 sec 20 sec 30 sec
5139 days 123 days 110 days
10 123 days 100 days 84 days
20 100 days 73 days 57 days
40 73 days 47 days 35 days
Score events
entered by day
C-13
Nearly all Actiwatch devices use the CR2025 coin-cell battery. The methods used
to change the battery are identical for all current devices. If you have an earlier
Actiwatch, refer to the Instruction Manual for that device, or read the Battery
Change Instructions included with the battery change kits available from Mini
Mitter.
Actiwatch Battery Replacement Procedure
CAUTION! The latest Actiwatch-Score models (serial numbers having
a D prex, e.g. Dxxxxx) use a CR 2025 battery. Earlier Actiwatch- Score
models (serial numbers having an N prex, e.g. Nxxxxx), use a CR 2032
battery. These batteries are not interchangeable, and may result in
electronic or mechanical destruction. Use of the improper battery will void
the warranty.
Battery Change Wizard
Actiware 5.0 contains a Change Battery Wizard.Thewizardwilltakeyou
through the process step-by-step, from replacing the battery to testing the
Actiwatch and changing the battery fitted date.
CAUTION! It is important that you thoroughly read the following
information prior to changing the battery. Failure to follow procedures
may result in immediate or subsequent damage to the product.
C-14 Actiwatch Hardware
CAUTION! To retain the integrity of the waterproof seal, it is
recommended that you change the O-ring in the battery compartment at the
same time you change the battery.
The Actiwatch battery is required for data collection, reading, and writing.
Actiwatch has a non-volatile memory, i.e., data stored are not lost after the
battery has run down. If you are attempting to read a device with a low battery,
the Ready LED will still light on the reader. It is recommended that you keep a
log of the battery changes for each Actiwatch.
The Actiwatch battery is a CR2025, 3-Volt, 220-mAmp-hour Lithium Manganese
cell. To properly install this battery, specific items may be required. These items
are included in the Battery Change Kit from Mini Mitter.
Typical Battery Replacement Kit
Description Quantity
O-ring 6
Battery, 3V lithium cell (CR2025) 6
Screwdriver, flat head 1
Screw, machine, 1.6 x 6 mm 24
Cotton swabs 12
Instructions 1 set
Additional materials that may be required:
Denatured alcohol
X-Acto® knife blade (flat tip) or similar sharp knife
1. Remove the band from the watch. Use the screwdriver supplied to loosen
(approximately five full turns) or remove the screws in the slots in the
battery cover of the Actiwatch.
C-15
2. Carefully remove the battery cover. If you have loosened the screws, press
down slightly and rotate the cover clockwise. If you have removed the
screws, simply lift the cover free from the frame.
3. Remove the battery and discard. See warning below!
WARNING! Dispose of lithium batteries appropriately. Do not incinerate
due to risk of explosion.
CAUTION! Use extreme care to avoid scratching the metal surface of the
device or battery cover. Scratches can cause the watch to leak.
4. Thoroughly clean the O-ring channel with alcohol.
CAUTION! Prior to assembling the Actiwatch, check carefully for lint,
hairs, or other debris which may compromise the seal integrity.
5. Place a new O-ring into the channel in the back cover as shown below.
Use the following technique:
• Pre-stretch the O-ring by gently flexing it in several directions.
• Place a portion of the O-ring in the channel and hold it with your
thumb or finger as shown below.
C-16 Actiwatch Hardware
• Use a finger on the other hand to guide the O-ring into the channel.
• Be sure that the O-ring is properly seated in the channel, and is not twisted
or deformed.
o-ring channel
6. Place a new battery into the Actiwatch case, positive (+) side up as shown
below.
7. Replace the back cover on Actiwatch and replace the screws. If the screws
have not been removed completely, rotate the back cover counterclockwise
until the slots in the back are firmly seated around the screws, and the back is
square with the case.
8. Tighten all four screws in an “X” pattern until all screws are snug. Take care
not to over-tighten to the extent of stripping the threads or twisting off the
heads.
CAUTION! DO NOT over tighten the screws. They can be easily stripped.
1
2
3
4
C-17
Actiwatch Cleaning Procedure
The Actiwatch and band may be cleaned by using a cloth moistened with a
mild detergent and warm water. Do not use bleach, alcohol, cleaning solutions
containing alcohol, or any strong household cleaners.
Cleaning the Actiwatch Band
Actiwatch bands can be washed and reused. However, it should be noted that
ActiwatchstudiesinvolvemountingActiwatchonthebody.Withsomesubjects,
this may raise particular sensitivities with respect to reusing the bands, and that
should be taken into consideration. Additional bands are inexpensive and are
available from the manufacturer. Clean the band as follows.
1 Remove the band from the device.
2 Hand wash the band in warm water with a mild detergent. Rinse.
3 Gently dry with a paper towel or soft cloth, or air dry.
Cleaning the Actiwatch Device
Only when the battery cover is installed and the fully sealed should Actiwatch be
cleaned.
CAUTION! Do not clean this device while the battery cover is off.
Clean the Actiwatch device as follows.
1 Clean with the battery cover on.
2 Wet a corner of a clean cloth with warm water. Add a drop or two of mild
detergent to the wet cloth and gently wipe the Actiwatch device. Wet another
corner with warm water and wipe away soap residue.
3 Gently dry with a paper towel or soft cloth.
4 Mount the Actiwatch back on the clean band.
C-18 Actiwatch Hardware
D-1
AppENdIx
D
S
PECIFICATION
All communication with Actiwatch is accomplished using an ActiReader that
is connected to a computer via an RS-232 Serial Port. This connection to the
computer supplies power and communication instructions. Settings made prior to
the start of data collection, as well as all data values, are communicated through
this device. The Actiwatch and ActiReader communicate using short range radio
telemetry. Readers are not “unit specific,” i.e., any Actiwatch may communicate
with any ActiReader or Actiwatch Reader.
There are four models of Actiwatch currently available:
Actiwatch®-64
Actiwatch-64 contains 64 KB of on-board memory. Chronobiological studies
can be conducted over several weeks because intervals longer than five
minutes may be selected. An eventmarkerbuttonallowssubjectstomark
times at which important events occur.
Actiwatch®-16
Similar to the Actiwatch-64, but Actiwatch-16 has 16 KB of memory.
Actiwatch®-L
Actiwatch-L measures activity and ambient light exposure (illuminance).
Actiwatch-L does not have an event marker button.
Actiwatch®-Score
Actiwatch-Scoremeasuresactivityandsubjectiveweightingofspecifictimes
or events.
D-2 Specifications
Specication for Actiwatch-16/64
ENVIRONMENTAL
Operating Storage
Temperature 0° C to 40° C
(32° F to 104° F) -10° C to 50° C
(14° F to 122° F)
Relative Humidity 0 to 95% RH 0 to 95% RH
Atmospheric Pressure 500 to 1060kPa
(5600 feet to sea level)
PHYSICAL
Dimensions: 29 L x 37 W x 12 H (mm)
Weight: 16 grams w/o band
22 grams with standard band
Case Material: Polyurethane/Polyester Alloy
Frame and Battery Cover: Titanium
Standard Wrist Band: Nylon with buckle
ELECTRICAL
Battery Type: CR 2025 Lithium
Battery Life: 6 Months Typical
Protection Against Electric
Shock: Internally powered
Degree of Protection Against
Electric Shock: Type BF Applied Part
Modes of Operation: Continuous
Electromagnetic Compatibility: The device meets the
requirements of EN 60601-1-2, second
edition (2001).
Fuses: There are no user-replaceable fuses.
Degree of Protection Against
Ingress of Water: Water tight to a depth of 1 meter for 30 minutes
IEC Standard IPX7
D-3
FUNCTIONAL
Parameter Value Note
Accelerometer sensitivity 0.05 g-force
Accelerometer bandwidth 3Hzto11Hz
Sampling epochs 15 and 30 seconds,
1, 2, 5, 10, and 15 minutes Actiware-PLM software
configures Actiwatch to
sample at 2 second epoch
length.
Memory 16 or 64 kB 16 kB in Actiwatch-16 only
STANDARDS COMPLIANCE
Test Standard Description
IEC60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety
IEC60601-1-1 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems
IEC60601-1-2 Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
IEC60950-1 Information Technology Equipment - Safety - Part 1:
General Requirements
DISPOSAL
When necessary, dispose of the device and accessories in accordance with local regulations.
D-4 Specifications
Specication for Actiwatch-Score
ENVIRONMENTAL
Operating Storage
Temperature 0° C to 40° C
(32° F to 104° F) -10° C to 50° C
(14° F to 122° F)
Relative Humidity 0 to 95% RH 0 to 95% RH
Atmospheric Pressure 500 to 1060kPa
(5600 feet to sea level)
PHYSICAL
Dimensions: 37 L x 35 W x 12 H (mm)
Weight: 19 grams w/o band
25 grams with standard band
Case Material: Glass-filled Nylon
Frame and Battery Cover: Titanium
Standard Wrist Band: Nylon with buckle
ELECTRICAL
Battery Type: CR 2025
Battery Life: 3 Months Typical
Protection Against Electric
Shock: Internally powered
Degree of Protection Against
Electric Shock: Type BF Applied Part
Modes of Operation: Continuous
Electromagnetic
Compatibility: The device meets the
requirements of EN 60601-1-2,
second edition (2001).
Fuses: There are no user-replaceable
fuses.
Degree of Protection Against
Ingress of Water: Dripping and light splashing of
liquids
IEC Standard 60529 IPX2
D-5
FUNCTIONAL
Parameter Value Note
Accelerometer sensitivity 0.05 g-force
Accelerometer bandwidth 3Hzto11Hz
Sampling epochs 15 and 30 seconds,
1, 2, 5, 10, and 15 minutes
Memory 32 kB
Scoring levels 0 to 15 User-selectable
Number of scores per epoch One
STANDARDS COMPLIANCE
Test Standard Description
IEC60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety
IEC60601-1-1 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems
IEC60601-1-2 Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
IEC60950-1 Information Technology Equipment - Safety - Part 1:
General Requirements
DISPOSAL
When necessary, dispose of the device and accessories in accordance with local regulations.
D-6 Specifications
Specication for Actiwatch-L
ENVIRONMENTAL
Operating Storage
Temperature 0° C to 40° C
(32° F to 104° F) -10° C to 50° C
(14° F to 122° F)
Relative Humidity 0 to 95% RH 0 to 95% RH
Atmospheric Pressure 500 to 1060kPa
(5600 feet to sea level)
PHYSICAL
Dimensions: 29 L x 37 W x 11 H (mm)
Weight: 16 grams w/o band
22 grams with standard band
Case Material: Glass-filled Nylon
Frame and Battery Cover: Titanium
Standard Wrist Band: Nylon with buckle
ELECTRICAL
Battery Type: CR 2025
Battery Life: 3 Months Typical
Protection Against Electric
Shock: Internally powered
Degree of Protection Against
Electric Shock: Type BF Applied Part
Modes of Operation: Continuous
Electromagnetic
Compatibility: The device meets the
requirements of EN 60601-1-2, second
edition (2001).
Fuses: There are no user-replaceable fuses.
Degree of Protection Against
Ingress of Water: Waterproof / Watertight to a depth of 1
meter for 30 minutes
IEC 60529 IPX7
DISPOSAL
When necessary, dispose of the device and accessories in accordance with local regulations.
D-7
FUNCTIONAL
Parameter Value Note
Accelerometer sensitivity 0.05 g-force
Accelerometer bandwidth 3Hzto11Hz
Sampling epochs 15 and 30 seconds,
1, 2, 5, 10, and 15 minutes
Memory 64 kB
Sensor Type Photodiode On-board sensor
Spectral response CIE Y-curve Approximate
Wavelength window 330 to 720 nm
Minimum illuminance sensitivity 0.1 lux
Maximum illuminance sensitivity 150,000 lux
Linearity 2% Typical from 0.1 to 150,000
lux
Resolution 2% of lux value Typical
STANDARDS COMPLIANCE
Test Standard Description
IEC60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety
IEC60601-1-1 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems
IEC60601-1-2 Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
IEC60950-1 Information Technology Equipment - Safety - Part 1:
General Requirements
Logging Capacity versus Amount of Memory
EPOCH LENGTH (minutes)
0.25 0.50 1.00 2.00 5.00 10.0 15.0
Bytes Logging Capacity (days) by Epoch Length
Actiwatch-16 (kB) 2.8 5.6 11.2 23 56 113 170
Actiwatch-64 (kB) 11.3 22 45 90 227* 365* 365*
Actiwatch-L (32 kB) 2.8 5.6 11.3 28 56 113 170
Actiwatch-Score (32 kB) 5.5 11.1 22 44 111+ 223+ 334+
Actiwatch-L (64 kB) 3.7 7.2 15 30 75 151 227*
*Limited by 180 day battery life.
+Limited by 90 day battery life.
D-8 Specifications
Specication for ActiReader
ENVIRONMENTAL
Operating Storage
Temperature 0° C to 40° C
(32° F to 104° F) -10° C to 50° C
(14° F to 122° F)
Relative Humidity 0 to 95% RH 0 to 95% RH
Atmospheric Pressure 500 to 1060kPa
(5600 feet to sea level)
PHYSICAL
Dimensions: 114 L x 72 W x 34 H (mm)
Weight: 158 grams
Case Material: ABS plastic
ELECTRICAL
Data Port DB9 Serial Port (a compatible USB to serial port
adapter can be used)
Battery Type: 9V Lithium (Eveready™ L522)
Battery Life: 6 Months
Typical (Turn off ActiReader when not being used)
AC Voltage Source: 100to240VAC,50/60Hz
DC Voltage Source: 9-12V DC (when operated with the external DC
power adaptor accessory)
AC Current: 0.4 A maximum
DC Current: 1.5 A maximum
Protection Against Electric
Shock: Internally powered
Degree of Protection Against
Electric Shock: Type BF Applied Part
Sterile Non-Sterile
Modes of Operation: Continuous
Electromagnetic Compatibility: The device meets the
requirements of EN 60601-1-2, second edition
(2001).
Fuses: There are no user-replaceable fuses.
Power Supply Model Nos: DSA-0151D-12
D-9
STANDARDS COMPLIANCE
Test Standard Description
IEC60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety
IEC60601-1-1 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems
IEC60601-1-2 Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
IEC60950-1 Information Technology Equipment - Safety - Part 1:
General Requirements
DISPOSAL
When necessary, dispose of the device and accessories in accordance with local regulations.
D-10 Specifications
Hereby,
Mini Mitter Company, Inc.
A Respironics, Inc. Company
20300 Empire Avenue, Building B-3
Bend, OR 97701,
declares that this class 1 radio equipment is in compliance with the essential requirements and other
relevantprovisionsofDirective1999/5/EEC.Itcomplieswiththefollowingharmonizedstandards
for radio equipment: EN 300 220-3 V1.1.1 (2000-09), EN 301 489-01 V1.4.1 (2002-08), and EN 301
489-03 V1.4.1 (2002-08).
Dan Burns Date
Manager, Quality Assurance
E-1
AppENdIx
E
EMC I
NFORMATION
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specified 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 This 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 This device is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies
E-2 EMC Information
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this
device should make sure it is used in such an environment.
Immunity
Test IEC 60601 Test
Level Compliance
Level Electromagnetic Environment -
Guidance
Electrostatic
Discharge
(ESD)
IEC 61000-4-2
±6V contact
±8V air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
Transient/burst
IEC 61000-4-4
±2kV for power
supply lines
±1kV for input/
output lines
±2kV for supply
mains
±1kV for input/
output lines
Mains power quality should be that of a
typical home or hospital environment.
It is noted certification to IEC 60601-
1-2isobtainedrecognizingthat
interruption of the download of data to
the reader due to EMI is not considered
to cause harm. When a download is
stopped, the user is prompted that
and error has occurred and the user
would then reinitiate the download.
Interference that would interrupt a
download is anticipated to be of short
duration such that the subsequent
download would be successful.
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
±1kV differential
mode
±2kV common
mode
Mains power quality should be that of a
typical home or hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
<5% UT
(>95% dip in UT )
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT (30%
dip in UT) for 25
cycles
<5% UT (>95%
dip
in UT) for 5 sec
<5% UT
(>95% dip in UT )
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT (30%
dip in UT) for 25
cycles
<5% UT (>95%
dip in UT) for 5
sec
Mains power quality should be that of a
typical home or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
E-3
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this
device should make sure it is used in such an environment.
Immunity test IEC 60601
Test Level Compliance
Level (FDA) Electromagnetic Environment -
Guidance
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical home or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150kHzto80
MHz
3 V/m
80MHzto
2.5GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
It is noted certification to IEC 60601-1-2
isobtainedrecognizingthatinterruption
of the download of data to the reader due
to EMI is not considered to cause harm.
When a download is stopped, the user is
prompted that and error has occurred and
the user would then reinitiate the download.
Interference that would interrupt a download
is anticipated to be of short duration such
that the subsequent download would be
successful.
Recommended Separation Distance
Pd 2.1=
Pd 2.1=
80MHzto800MHz
Pd 3.2=
800MHzto2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
E-4 EMC Information
Note1:At80MHzand800MHzthehigherfrequencyrangeapplies.
Note2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreectionfrom
structures,objectsandpeople
aFieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagneticenvironmentduetoxedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasured
eldstrengthinthelocationinwhichthedeviceisusedexceedstheapplicableRFcompliancelevelabove,thedeviceshould
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the device.
bOverthefrequencyrange150kHzto80MHz,theeldstrengthsshouldbelessthan3V/m.
E-5
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and This Device
This device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of this device can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communication equipment
(transmitters) and this device as recommended below, according to the maximum output power of the
communications equipment.
Rated
Maximum
Power Output
of Transmitter
(W)
Separation Distance According to Frequency of Transmitter
(m)
150 kHz to 80
MHz
Pd 2.1=
80 MHz to 800
MHz
Pd 2.1=
800 MHz to 2.5 GHz
Pd 3.2=
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
byabsorptionandreflectionfromstructures,objectsandpeople.
E-6
910-0025-01 Rev B
JW 12/08/2006
FCC and Industry Canada Compliance Information
Warning: Changes or modifications to this device not expressly approved by Respironics/Mini Mitter could
void the user’s authority to operate the equipment.
FCC:
NOTE: 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 or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Industry Canada:
The term “IC:” before the radio certification number only signifies that Industry Canada technical
specifications were met.
This Class B digital apparatus meets all requirements of the Canadian Interference Causing Equipment
Regulations. 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.
Cet appareillage numérique de la classe répond à toutes les exigences de l'interférence canadienne
causant des règlements d'équipement. L'opération est sujette aux deux conditions suivantes: (1) ce
dispositif peut ne pas causer l'interférence nocive, et (2) ce dispositif doit accepter n'importe quelle
interférence reçue, y compris l'interférence qui peut causer l'opération peu désirée.

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