Act I Watch Software

Instruction Manual
Actiwatch Communication and

Sleep Analysis Software
Actiware® 5.0 and Actiware-CT 5.1
Actiwatch-16, -64, -Score, -L
Actireader
Actiwatch -16 / Actiwatch -64 ® ®
Actiwatch -L / Actiwatch -Score ® ®
Actiware 5.0 / Actiware -CT 5.1 ® ®
Actiwatch Communication and

Sleep Analysis Software
Instruction Manual
Respironics, Mini-Mitter, Actiwatch, and Actiware are registered trademarks of Respironics, Inc. and its affiliates.
Windows is a registered trademark of Microsoft Corporation.
Pentium is a registered trademark of Intel.
ActiReader is covered by the following US patent numbers: 6,129,663. Other patents pending.
© 2006 Respironics, Inc. and its affiliates. All rights reserved.

Mini Mitter, a Respironics Company
WARRANTY POLICY
1. WARRANTY : Mini Mitter, a Respironics Company, warrants that upon delivery the goods sold hereunder will be free of defects
in materials and workmanship, and such goods will substantially conform to the specifications furnished by the Seller, and to any
drawings or specifications furnished to the Buyer by the Manufacturer (Mini Mitter, a Respironics Company) if approved by the
Manufacturer.
a) Commencement of Warranty – The warranty period begins on the date of delivery.
b) Duration of Warranty – The goods sold hereunder are warranted for a period of twelve months, except PDT-4000 and PDT-
4000HR, which are warranted for two years.
c) Third Party Product Warranty – Third party products purchased by Buyer through the Manufacturer are covered by the third
party’s warranty and ARE NOT COVERED BY THE MANUFACTURER WARRANTY.
d) Place of Repair or Replacement. Buyer must return the defective or nonconforming goods upon request to Mini Mitter, a
Respironics Company, at 20300 Empire Avenue, Building B-3; Bend, OR 97701, 800-685-2999 (US or Canada only) or 1-541-598-
3800, not later than 15 days after the Manufacturer’s receipt of notice of the alleged defect or nonconformance. Buyer shall
prepay transportation charges. The Manufacturer shall pay for the return of the goods to Buyer. No goods are to be returned to
the Manufacturer without prior authorization and a valid Return Authorization (RA) number.
e) Limitation of Warranty – The foregoing warranty shall not apply to defects resulting from (a) improper or inadequate
maintenance by Buyer; (b) unauthorized modification of the goods; (c) operation of the goods outside of the environmental
specifications for the goods; (d) neglect, misuse or abuse of the goods or (e) modification or integration with other goods not
covered by a Mini Mitter, a Respironics Company, warranty when such modification or integration increases the likelihood of
damage to the goods.
f ) Technical assistance – The warranty set forth above shall not be enlarged, diminished or affected by and no obligation or
liability shall arise from the Manufacturer’s rendering of technical advice, assistance or services in connection with Buyer’s order
of the goods furnished hereunder. The Buyer is not relying on the Manufacturer’s skill or judgment to select or furnish suitable
goods.
THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND THE MANUFACTURER GIVES NO OTHER WARRANTY WRITTEN
OR VERBAL, EXPRESS OR IMPLIED. MINI MITTER, A RESPIRONICS COMPANY, SPECIFICALLY DISCLAIMS THE IMPLIED
WARRANTIES OF MERCHANT-ABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THE MANUFACTURER’S STANDARD
WARRANTY POLICY COVERING ANY OF THE MANUFACTURER’S PRODUCTS SHALL BE NULL, VOID, AND OF NO EFFECT IF THE
BUYER OR ANY THIRD PARTY USES THAT PRODUCT FOR ANY USE OTHER THAN THE INTENDED USE OF THAT PRODUCT.
2. LIMITATION OF REMEDIES AND LIABILITY. The remedies provided herein are Buyer’s sole and exclusive remedies.
The Manufacturer shall have no responsibility other than, at the Manufacturer’s option, to repair or replace defective or
nonconforming goods or to refund the purchase price of defective or nonconforming goods in the event of breach of
any warranty. IN NO EVENT SHALL THE MANUFACTURER BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS) WHETHER BASED ON CONTRACT, TORT OR ANY OTHER LEGAL
THEORY. In the event that any limitation of warranty or disclaimer of liability is found to be unlawful or inapplicable, or to have
failed of its essential purpose, the Manufacturer’s liability shall be limited to the amount paid by the Buyer for the specific goods
that caused such liability.
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MINI MITTER, a Respironics Company
SOFTWARE LICENSE AGREEMENT

NOTICE TO USER: BY CLICKING THE “I ACCEPT THE TERMS IN THE LICENSE AGREEMENT” BUTTON, THE USER (“YOU”) AGREE(S) TO BE
BOUND BY THE TERMS OF THIS SOFTWARE LICENSE AGREEMENT (“AGREEMENT”). BY CLICKING YES YOU ACCEPT ALL THE TERMS
AND CONDITIONS OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, THE RESTRICTIONS ON: USE CONTAINED IN SECTION
2; TRANSFERABILITY IN SECTION 4; WARRANTY IN SECTION 6; AND LIABILITY IN SECTION 7. YOU AGREE THAT THIS AGREEMENT IS
ENFORCEABLE LIKE ANY WRITTEN NEGOTIATED AGREEMENT SIGNED BY YOU. IF YOU DO NOT AGREE TO BE BOUND TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT, YOU MAY OBTAIN A REFUND OF ANY AMOUNT YOU ORIGINALLY PAID IF YOU: (A) DO NOT USE THE
SOFTWARE AND (B) RETURN THE SOFTWARE, WITH PROOF OF PAYMENT, TO THE LOCATION FROM WHICH IT WAS OBTAINED WITHIN
THIRTY (30) DAYS OF THE PURCHASE DATE.
1. Definitions. “Software” means (a) all of the contents of the files, disk(s), CD-ROM(s) or other media with which this Agreement
is provided, including but not limited to (i) MINI MITTER or third party computer information or software; (ii) related explanatory
written materials or files (“Documentation”); and (b) upgrades, modified versions, updates, additions, and copies of the Software,
if any, licensed to you by MINI MITTER (collectively, “Updates”). “Use” or “Using” means to access, install, download, copy or
otherwise benefit from using the functionality of the Software in accordance with the Documentation. “Permitted Number”
means one (1) unless otherwise indicated under a valid license (e.g. volume license) granted by MINI MITTER. “Computer” means
an electronic device that accepts information in digital or similar form and manipulates it for a specific result based on a sequence
of instructions. “MINI MITTER” means MINI MITTER, a Respironics Company, 20300 Empire Ave., Bldg B-3, Bend, Oregon 97701.
2. Software License.
2.1 Grant. MINI MITTER owns all intellectual property in the Software. MINI MITTER hereby grants you a limited, non-exclusive
license to Use the Software only in accordance with the terms of this Agreement and for the purposes described in the
Documentation. Use of some third party materials included in the Software may be subject to other terms and conditions found
in a separate license agreement.
2.2 General Use. You may install and Use a copy of the Software on your compatible Computer, up to the Permitted Number of
Computers.
2.3 Backup Copy. You may make one backup copy of the Software, provided your backup copy is not installed or used on
any Computer. You may not transfer the rights to a backup copy unless you transfer all rights in the Software as provided under
Section 4.
2.4 No Modification. You may not alter or modify the Software or create a new installer for the Software. The Software is
licensed and distributed by MINI MITTER for Use with its data collection hardware products.
3. Intellectual Property Ownership and Copyright Protection. The Software and any authorized copies that you make are the
intellectual property of and are owned by MINI MITTER. The structure, organization and code of the Software are the valuable
trade secrets and confidential information of MINI MITTER. The Software is protected by law, including without limitation, the
copyright laws of the United States and other countries, and by international treaty provisions. Except as expressly stated
herein, this Agreement does not grant you any intellectual property rights in the Software and all rights not expressly granted
are reserved by MINI MITTER. You hereby recognize that MINI MITTER retains all intellectual property rights in the Software,
Documentation and all MINI MITTER confidential information, including without limitation, all corrections, modifications and
other derivative works to the Software. You hereby assign to MINI MITTER all intellectual property rights you may now or hereafter
possess in the Software, Documentation and MINI MITTER confidential information, and all derivative works thereof and you
agree to execute all documents, and take all actions, that may be necessary to confirm such rights. You agree to observe complete
confidentiality with respect to the MINI MITTER confidential information; not to disclose, or permit any third party or entity access
to, the MINI MITTER confidential information (or any portion thereof ) without prior written permission of MINI MITTER, and to
insure that any employees, or any third parties who receive access to the MINI MITTER confidential information, are advised of the
confidential and proprietary nature thereof and are prohibited from copying, utilizing or otherwise revealing the MINI MITTER
confidential information. You agree to employ with regard to the MINI MITTER confidential information commercially reasonable
procedures that are no less restrictive than the strictest procedures used by it to protect its own confidential and proprietary
information.
4. Restrictions.

4.1 Notices. You shall not copy the Software except as set forth in Section 2. Any copy of the Software that you make must
contain the same copyright and other proprietary notices that appear on or in the Software, indicating that the Software are
owned by MINI MITTER.
4.2 No Modifications. You shall not modify, adapt or translate the Software. You shall not reverse engineer, decompile,
disassemble or otherwise attempt to discover the source code of the Software.
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4.3 Transfer. You may not, rent, lease, sublicense, assign or transfer your rights in the Software, or authorize all or any portion of
the Software to be copied onto another user’s Computer except as may be expressly permitted herein. You may, however, transfer
all your rights to Use the Software to another person or legal entity provided that: (a) you also transfer (i) this Agreement, and (ii)
the Software and all other software bundled or pre-installed with the Software, including all copies, Updates and prior versions,
to such person or entity; (b) you retain no copies, including backups and copies stored on a Computer; and (c) the receiving party
accepts the terms and conditions of this Agreement and any other terms and conditions upon which you legally purchased a
license to the Software. Notwithstanding the foregoing, you may not transfer education, pre-release, or not for resale copies of the
Software.
5. Updates. If the Software is an Update to a previous version of the Software, you must possess a valid license to such previous
version in order to Use such Update. All Updates are provided to you on a license exchange basis. You agree that by Using an
Update you voluntarily terminate your right to Use any previous version of the Software. As an exception, you may continue to
Use previous versions of the Software on your Computer after you Use the Update but only to assist you in the transition to the
Update, provided that: (a) the Update and the previous versions are installed on the same computer; (b) the previous versions
or copies thereof are not transferred to another party or Computer unless all copies of the Update are also transferred to such
party or Computer; and (c) you acknowledge that any obligation MINI MITTER may have to support the previous versions of the
Software may be ended upon availability of the Update. All Updates will be provided to you in the sole discretion of MINI MITTER.
6. LIMITED WARRANTY.
6.1 Limited Warranty. MINI MITTER warrants for a period of twelve (12) months after the date of delivery to you (the “Warranty
Period”), the following: (a) that the Software will perform in substantial compliance with the Documentation, provided that it is
used with the data collection hardware, Computer hardware and with the operating system for which it was designed, (b) that
the media on which the Software is distributed is substantially free from significant defects in materials and workmanship. MINI
MITTER shall have no obligation to provide warranty services if the defect in the Software is caused by malfunction of non-MINI
MITTER hardware or software, by modification of the Software not made by MINI MITTER, by operator error, or by use of the
Software that is not in accordance with the operating instructions and Documentation for the Software.
6.2 Disclaimer. EXCEPT AS PROVIDED IN SECTION 6.1, MINI MITTER AND ITS SUPPLIERS MAKE NO WARRANTIES OR
REPRESENTATIONS, WHETHER EXPRESS OR IMPLIED WHETHER BY STATUTE, COMMON LAW, CUSTOM, USAGE OR OTHERWISE,
AS TO ANY MATTER INCLUDING WITHOUT LIMITATION NONINFRINGEMENT OF THIRD PARTY RIGHTS, MERCHANTABILITY,
INTEGRATION, SATISFACTORY QUALITY, OR FITNESS FOR ANY PARTICULAR PURPOSE. The provisions of Section 6 and Section 7
shall survive the termination of this Agreement, howsoever caused, but this shall not imply or create any continued right to Use
the Software after termination of this Agreement.
6.3 Warranty Claims. Warranty claims must be made in writing during the Warranty Period and within seven (7) days of the
observation of the defect, accompanied by evidence satisfactory to MINI MITTER. All Software should be returned to MINI
MITTER or the MINI MITTER distributor from which it was purchased and shall be shipped by the returning party with freight and
insurance paid.
7. LIMITATION OF LIABILITY. IN NO EVENT WILL MINI MITTER OR ITS SUPPLIERS BE LIABLE TO YOU FOR ANY DAMAGES, CLAIMS
OR COSTS WHATSOEVER OR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL DAMAGES, OR ANY LOST PROFITS OR LOST SAVINGS,
EVEN IF A MINI MITTER REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS, DAMAGES, CLAIMS OR COSTS
OR FOR ANY CLAIM BY ANY THIRD PARTY. THE FOREGOING LIMITATIONS AND EXCLUSIONS APPLY TO THE EXTENT PERMITTED
BY APPLICABLE LAW IN YOUR JURISDICTION. MINI MITTER’S AGGREGATE LIABILITY AND THAT OF ITS SUPPLIERS UNDER OR IN
CONNECTION WITH THIS AGREEMENT SHALL BE LIMITED TO THE AMOUNT PAID FOR THE SOFTWARE, IF ANY. MINI MITTER is acting
on behalf of its suppliers for the purpose of disclaiming, excluding and/or limiting obligations, warranties and liability as provided
in this Agreement, but in no other respects and for no other purpose.
8. Export Rules. You agree that the Software will not be shipped, transferred or exported into any country or used in any manner
prohibited by the United States Export Administration Act or any other export laws, restrictions or regulations (collectively the
“Export Laws”). In addition, if the Software is identified as export controlled items under the Export Laws, you represent and
warrant that you are not a citizen, or otherwise located within, an embargoed nation (including without limitation Iran, Iraq, Syria,
Sudan, Libya, Cuba, North Korea, and Serbia) and that you are not otherwise prohibited under the Export Laws from receiving the
Software. All rights to Use the Software are granted on condition that such rights are forfeited if you fail to comply with the terms
of this Agreement.
9. Governing Law. This Agreement will be governed by and construed in accordance with the substantive laws in force in the State
of Oregon, USA, without regards to its conflicts of laws principles.
10. Term. The term of this Agreement shall begin on your acceptance and continue until the Agreement is terminated.
10.1 Termination for Cause. In the event of any material breach of this Agreement, the non-breaching party may terminate this
Agreement by giving thirty (30) days’ prior written notice to the other party; provided, however, that this Agreement shall not
terminate if the other party has cured the breach prior to the expiration of such thirty (30) day period.
10.2 Termination for Insolvency. Either party may terminate this Agreement, without notice, (i) upon the institution by or
against the other party of insolvency, receivership or bankruptcy proceedings, (ii) upon the other party’s making an assignment
for the benefit of creditors, or (iii) upon the other party’s dissolution or ceasing to do business.

10.3 Return of Materials. Upon termination of this Agreement for any reason, you shall return to MINI MITTER all copies of the
Software, confidential information, Documentation and all other tangible materials related to the Software, including without
limitation, all modifications and derivative works thereof.
11. General Provisions. If any part of this Agreement is found void and unenforceable, it will not affect the validity of the balance of
this Agreement, which shall remain valid and enforceable according to its terms. This Agreement shall not prejudice the statutory
rights of any party dealing as a consumer. This Agreement may only be modified by a writing signed by an authorized officer of
MINI MITTER. Updates may be licensed to you by MINI MITTER with additional or different terms. This is the entire Agreement
between MINI MITTER and you relating to the Software and it supersedes any prior representations, discussions, undertakings,
communications or advertising relating to the Software.
12. Notice to U.S. Government End Users. The Software and Documentation are “Commercial Items,” as that term is defined at
48 C.F.R. §2.101, consisting of “Commercial Computer Software” and “Commercial Computer Software Documentation,” as such
terms are used in 48 C.F.R. §12.212 or 48 C.F.R. §227.7202, as applicable. Consistent with 48 C.F.R. §12.212 or 48 C.F.R. §§227.7202-
1 through 227.7202-4, as applicable, the Commercial Computer Software and Commercial Computer Software Documentation
are being licensed to U.S. Government end users (a) only as Commercial Items and (b) with only those rights as are granted to all
other end users pursuant to the terms and conditions herein. Unpublished-rights reserved under the copyright laws of the United
States. Manufacturer is MINI MITTER, a Respironics. Company, 20300 Empire Ave., Bldg B-3, Bend, Oregon 97701, USA. For U.S.
Government End Users, MINI MITTER agrees to comply with all applicable equal opportunity laws including, if appropriate, the
provisions of Executive Order 11246, as amended, Section 402 of the Vietnam Era Veterans Readjustment Assistance Act of 1974
(38 USC 4212), and Section 503 of the Rehabilitation Act of 1973, as amended, and the regulations at 41 CFR Parts 60-1 through
60-60, 60-250, and 60-741.
13. Compliance with Licenses. You agree that upon request from MINI MITTER or MINI MITTER’s authorized representative, you will
within thirty (30) days fully document and certify that Use of any and all Software at the time of the request is in conformity with
your valid license from MINI MITTER.
14. Specific Exceptions.
14.1 Pre-release Product Additional Terms. If the product you have received with this license is pre-commercial release or beta
Software (“Pre-release Software”), then the following Section applies. To the extent that any provision in this Section is in conflict
with any other term or condition in this Agreement, this Section shall supersede such other term(s) and condition(s) with respect
to the Pre-release Software, but only to the extent necessary to resolve the conflict. You acknowledge that the Software is a pre-
release version, does not represent final product from MINI MITTER, and may contain bugs, errors and other problems that could
cause system or other failures and data loss. Consequently, the Pre-release Software is provided to you “AS-IS”, and MINI MITTER
disclaims any warranty or liability obligations to you of any kind. WHERE LIABILITY CANNOT BE EXCLUDED FOR PRE-RELEASE
SOFTWARE, BUT IT MAY BE LIMITED, MINI MITTER’S LIABILITY AND THAT OF ITS SUPPLIERS SHALL BE LIMITED TO THE SUM OF
FIFTY DOLLARS (U.S. $50) IN TOTAL. You acknowledge that MINI MITTER has not promised or guaranteed to you that Pre-release
Software will be announced or made available to anyone in the future, MINI MITTER has no express or implied obligation to you to
announce or introduce the Pre-release Software and that MINI MITTER may not introduce a product similar to or compatible with
the Pre-release Software. Accordingly, you acknowledge that any research or development that you perform regarding the Pre-
release Software or any product associated with the Pre-release Software is done entirely at your own risk. During the term of this
Agreement, if requested by MINI MITTER, you will provide feedback to MINI MITTER regarding testing and use of the Pre-release
Software, including error or bug reports. If you have been provided the Pre-release Software pursuant to a separate written
agreement, your use of the Software is also governed by such agreement. You agree that you may not and certify that you will
not sublicense, lease, loan, rent, assign or transfer the Pre-release Software. Upon receipt of a later unreleased version of the Pre-
release Software or release by MINI MITTER of a publicly released commercial version of the Software, whether as a stand-alone
product or as part of a larger product, you agree to return or destroy all earlier Pre-release Software received from MINI MITTER
and to abide by the terms of the license agreement for any such later versions of the Pre-release Software. Notwithstanding
anything in this Section to the contrary, if you are located outside the United States of America, you agree that you will return
or destroy all unreleased versions of the Pre-release Software within thirty (30) days of the completion of your testing of the
Software when such date is earlier than the date for MINI MITTER’s first commercial shipment of the publicly released (commercial)
Software.
If you have any questions regarding this Agreement or if you wish to request any information from MINI MITTER please use the address
and contact information included with this product to contact us.
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Thank You! ... for purchasing products from Mini Mitter, a Respironics Company. If
you need assistance with Actiwatch; remember, support continues after
the purchase. If you have any problems or questions, please call our
Technical Support staff of technicians, engineers, and scientists. We are
available by telephone, fax, e-mail, or web site.
Contacting Technical Support
Mailing and Mini Mitter, a Respironics Company

20300 Empire Avenue, Bldg. B-3
Shipping Bend, OR 97701 USA
Address
Telephone (800) 685-2999 (US and Canada only)

(541) 598-3800
Fax (541) 322-7277
E-Mail mm@respironics.com
Web site www.minimitter.com

www.respironics.com
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Table of Contents
Software License Agreement.........................................................................................................................................iv
Contacting Technical Support.......................................................................................................................................vii
INTRODUCTION AND SETUP .....................................................................................................................................1-1

Indications for Use........................................................................................................................................................1-2
Intended Use..................................................................................................................................................................1-2
Warnings and Cautions................................................................................................................................................1-3
Symbols.........................................................................................................................................................................1-5
Installation Prerequisites..............................................................................................................................................1-6
Installing from a CD.......................................................................................................................................................1-7
Uninstallation Procedures . .......................................................................................................................................1-11
ActiReader Setup........................................................................................................................................................1-14
Actiwatch Reader........................................................................................................................................................1-20
ActiReader Battery Replacement Procedures..........................................................................................................1-21
GETTING STARTED . ...................................................................................................................................................2-1

Main Window..................................................................................................................................................................2-2
Actogram........................................................................................................................................................................2-8
Setting Intervals..........................................................................................................................................................2-10
Viewing Statistics........................................................................................................................................................2-17
Exporting Data.............................................................................................................................................................2-19
Print Report..................................................................................................................................................................2-21
New Subject.................................................................................................................................................................2-22
Deleting/Hiding Subjects............................................................................................................................................2-23
COMMUNICATIONS .....................................................................................................................................................3-1
Configure Actiwatch......................................................................................................................................................3-1
Retrieve Data from Actiwatch.......................................................................................................................................3-7
ADVANCED USAGE ....................................................................................................................................................4-1

Program Options...........................................................................................................................................................4-2
Analysis Parameter Definitions...................................................................................................................................4-4
Data List.......................................................................................................................................................................4-10
Text File Batch Export.................................................................................................................................................4-11
Import AWD Files.........................................................................................................................................................4-14
Graph............................................................................................................................................................................4-16
CLINICAL TRIALS..........................................................................................................................................................5-1
Audit Trail.......................................................................................................................................................................5-3
Introduction to Electronic Signatures.........................................................................................................................5-6
Database Validation and Back-up................................................................................................................................5-7
Export Files....................................................................................................................................................................5-7
SLEEP/WAKE ANALYSIS . .......................................................................................................................................... A-1

STATISTIC DEFINITIONS.............................................................................................................................................. B-1
ACTIWATCH HARDWARE ........................................................................................................................................... C-1
ACTIWATCH-L............................................................................................................................................................... C-5
ACTIWATCH-SCORE.................................................................................................................................................... C-8
Actiwatch Battery Replacement Procedure............................................................................................................. C-13
Actiwatch Cleaning Procedure................................................................................................................................. C-17
SPECIFICATION............................................................................................................................................................ D-1
EMC INFORMATION..................................................................................................................................................... E-1
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S ECTION
INTRODUCTION AND SETUP

1
Actiware / Actiware-CT
Actiware and Actiware-CT are Windows® based application software packages
that are designed to do the following:
● Manage subject (patient) information
● Configure Actiwatch devices for data collection
● Retrieve clinical data from Actiwatch devices
● View clinical data
● Analyze data for sleep parameters and rhythmicity
● Export raw data or statistics for external analysis or archive
Actiware-CT is also capable of clinical trial tracking and auditing in accordance

with 21 CFR Part 11.
This manual describes the functions of the Actiwatch and outlines the data
analysis and file management features available in the Actiware and Actiware-
CT software applications. Both applications are part of the Actiwatch activity
monitoring system. You can view and analyze the rhythmicity of long-term
activity-rest patterns.
1-1
Indications for Use
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
Important! Actiwatch 16/64, -L, -Score are not intended for use as
diagnostic devices; they are intended for use as physiological parameter
recorders.
1-2 Introduction and Setup

Warnings and Cautions
CAUTION! US federal law restricts this device to sale by or on the order of a physician.
WARNING! WARNING:
• The provider should read and understand this entire manual before using
A warning this device.
indicates the
• This manual serves as a reference. The instructions in this manual are not
possibility intended to supersede the health care professional’s instructions regarding
of injury to the use of this device.
the user or • Do not dispose of lithium batteries in fire or flame. An explosion may
operator. result. Only dispose in accordance with manufacturer’s recommendation or
local regulations.
• Operation of the device may be adversely affected by:

— Electromagnetic fields exceeding the level of 10 V/m in the test
conditions of EN 60601-1-2
— Operation of high frequency (diathermy) equipment
— Defibrillators or short wave therapy equipment
— Radiation (e.g., x-ray, CT)
— Magnetic fields (e.g., MRI)
• Do not use this device in the presence of a flammable anaesthetic mixture

in combination with oxygen or air, or in the presence of nitrous oxide.
• If you notice any unexplained changes in the performance of this device, if

it is making unusual or harsh sounds, if it has been dropped or mishandled,
or if the enclosure is broken, discontinue use. Contact Mini Mitter/
Respironics Technical Support and replace any damaged parts before
continuing use.
• ActiReader Only - To avoid electrical shock, disconnect the AC power

supply before cleaning. DO NOT immerse the AC power supply in any
fluids.
1-3
CAUTION! CAUTION:
• Repairs and adjustments must be performed by Mini Mitter/Respironics
A caution authorized service personnel only. Unauthorized service could cause injury,
indicates the invalidate the warranty, or result in costly damage.
possibility of • Dispose of these devices in accordance with local regulations.
damage to the
device.
Note
Note: Additional Warnings, Cautions, and Notes may appear
throughout this manual.
Places
emphasis on
an operating
characteristic.

Symbols
Symbol Meaning
Attention, consult accompaning documents
DC Power
Type BF Applied Part
Canadian/US Safety Certification
Protected against vertically falling water drops when

IPX2 enclosure tilts up to 15 degrees.
Protected against the effects of temporary immersion in
IPX7 water (Actiwatch 64, Actiwatch 16, Actiwatch-Light)
Alignment Indicator (ActiReader)
European Declaration of Conformity (conformance to

Radio and Telecommunications Terminal Equipment
(RTTE) Directive)
European Declaration of Conformity (conformance to
Medical Device Directive (MDD))
On (Power)
Off (Power)
9V
Lithium only Use 9V Lithium battery only
1-5
Installation Prerequisites
System • Microsoft Windows® 2000 or XP operating system

Windows XP Professional required for Actiware-CT
Requirements
• Computer with 2 GHz or higher process clock speed recommended;
500 MHz minimum requirement
• 512 MB RAM; 128 MB RAM minimum requirement
• 300 MB or higher recommended; 50 MB required for installation
• Super VGA (1280 x 1024) resolution video adapter and display

recommended; SVGA (800 x 600) minimum requirement
• CD-ROM or DVD drive (for installation)
• Keyboard and Microsoft Mouse or compatible pointing device
• 9-pin or 25-pin RS-232 communications serial port
• UL 1950, IEC 60950, or EN60950 approved computer
• Printer (optional)
• Note: Data for use by Actiware must reside on the local hard drive. It is not
recommended to install the program files or data on a network drive.
Note: Actiware / Actiware-CT was created for use with Windows®.

Windows is a registered trademark of the Microsoft® Corporation.
Note: Before beginning the installation procedure, make sure that no

other applications are currently running on the computer. This includes
Microsoft Office® and any other utilities. These can interfere with proper
installation, resulting in software conflicts.

First Time If this is the first time Actiware will be installed, please continue to Installing
Actiware later in this section.
Installation
Upgrading If you are upgrading from a previous version of Actiware (or Sleepwatch or
Rhythmwatch) you should remove any previously installed versions.
See Uninstallation Procedures later in this section.
CAUTION! Before proceeding, back up any previously gathered data

prior to installation. Store in a secure location, either on a floppy disk,
CD-ROM, or within a separate drive space.
Installing Actiware / Actiware-CT
Note: You must be a member of the Administrator’s group in order to

install this software.
Note: Users of Actiware (Research Version) must be a member of the

Power User or Administrator’s group in order to run the software.
Actiware-CT (version 5.1 or greater) users do not need to be a member of
the Power User or Administrative group.
Installing from a CD
1. Insert the CD-ROM into the CD/DVD drive and wait a moment for the
Installation Menu to appear. If the CD/DVD drive does not accommodate the
autorun function, then select Start > My Computer and select the CD/DVD
drive from the list and double-click to access the files.
Select CDMENU.EXE and double-click.
2. Select Install Actiware Version 5 from the menu.

Installation Menu provides several options: Install Actiware, Install Adobe Reader, View Manual,
Contact Mini Mitter.
1-7
3. The InstallShield™ Wizard will guide you through the installation process.
4. Check the radio button for I accept the terms in the license agreement.
Click the Next button to continue.
End-User License Agreement
Important! The Software License Agreement must be accepted before

installation will occur.
Note: Actiware-CT requires the user to authenticate using their Windows

or Network username and password. Please contact your local
administrator with any issues or questions.

Registering Actiware
Both versions of Actiware have a “try it before you buy it” feature. You may
download or otherwise obtain an evaluation copy of Actiware and use the
software prior to purchasing it. An activation key cannot be obtained without
first paying for a license; however this does not prevent you from installing and
running a full featured copy of Actiware for 30 days or 50 uses. Even if you have
purchased Actiware, it is not necessary to immediately register Actiware. Please
press the Continue Unregistered button to access Actiware software and contact
technical support via e-mail (mm@respironics.com) at a convenient time to
obtain your activation key.
NOTE: Registration is not needed for Actiware-CT 5.1 or greater.
Actiware activation window
When you purchase Actiware, a Proof of Purchase certificate will be shipped

with the installation CD. There will be a Proof of Purchase code printed on the
certificate. This code will always begin with “POP-xxxx-xxxx…” and cannot be
entered into the software and applied as an activation key. To obtain an activation
key, you will need to contact Mini Mitter/Respironics and give the Proof of
Purchase code to a customer service associate. The best and most efficient
method to contact technical support is via e-mail (mm@respironics.com). You
may also call technical support at 800.685.2999 during normal business hours of
8 am to 5 pm PST. The associate will then generate an activation key and e-mail
it to you. Once the activation key is applied to Actiware, it will never expire and
will be valid for all future versions of Actiware 5.x. The key however, will not
work in a future version 6.0 or greater.
1-9
Note: To deter the misuse of activation keys, the key can only be applied
for 7 days after it is generated.
There are two parts to an activation key: the e-mail address of the registered user
and the key itself. A key is very long and will look something like the following:
sleepdoctor@sleeplab.com
000016-BEMQ97-ZKNNYC-Z19ZG9-G11W7U-0TWCZT-U8W8C4-Z0WRG4-
ZBJXKT-NC20CA
When you receive your activation key, cut and paste the Registered User’s e-mail
and key as shown and press Enter Key.
Enter the Activation Key
Registration entitles the registered user access to technical support. When

contacting technical support, you may be required to provide your registration
information.

Uninstallation Procedures
CAUTION! Before uninstalling, back up any previously gathered data

and store in a secure location, either on a floppy disk, CD-ROM, or within
a separate drive space.
Automatically Uninstalling Previous Actiware Versions

1. Select Start > Control Panel > Add or Remove Programs.
2. Review the list for any Actiware application currently installed (Actiware-
Rhythm, Actiware-Sleep, RhythmWatch, SleepWatch). Select the Actiware
version from the list. If the Actiware software is not in the list, a manual
uninstallation will be required.
3. Click the Remove button.
4. When the confirmation pop-up window appears, select Yes to remove

Actiware.
This completes the automatic uninstall process. Delete any desktop or toolbar
icon shortcuts you may have created.
Manually Uninstalling RhythmWatch 2.82 or earlier

1. Using Windows Explorer, review the contents of the RhythmWatch
installation folder (commonly C:\RHYTHMW). Copy any .AWD data files
to a secure location such as a floppy disk or separate drive space.
2. Delete the installation folder (C:\RHYTHMW) and its contents.
3. Remove the RhythmWatch program folder from the Start menu. This can be
accomplished using the Start > Settings > Taskbar and Start Menu item, or
by right-clicking on the Start button and selecting Open. Also, delete any
desktop icon shortcuts you may have created.
This completes the uninstall process for RhythmWatch 2.82 or earlier.
1-11
Manually Uninstalling SleepWatch 2.82 or earlier
1. Using Windows Explorer, review the contents of the SleepWatch installation
folder (commonly C:\SLEEPW). Copy any .AWD and .AWS data files to a
secure location such as a floppy disk or separate drive space.
2. Delete the installation folder (C:\SLEEPW) and its contents.
3. Remove the SleepWatch program folder from the Start menu. This can be
accomplished using the Start > Settings > Taskbar and Start Menu item, or
by right-clicking on the Start button and selecting Open. Also, delete any
desktop icon shortcuts you have created.
This completes the uninstall process for SleepWatch 2.82 or earlier.
Manually Uninstalling Actiware-Rhythm or Actiware-Sleep 3.0

1. Using Windows Explorer, review the contents of the Actiware installation
folder (commonly C:\ACTIWARE for version 3.0). Copy any .AWD and
.AWS data files to a secure location such as a floppy disk or separate drive
space.
2. Delete the installation folder (C:\ACTIWARE) and its contents.
3. Remove the Actiware-Sleep or Actiware-Rhythm program folder from the

Start menu. This can be accomplished using the Start > Settings > Taskbar
and Start Menu item, or by right-clicking on the Start button and selecting
Open. In addition, delete any desktop icon shortcuts you have created.
This completes the uninstall process for Actiware 3.0.

or later
folder (commonly C:\Program Files\Actiware). Copy any .AWD, .AWS and
.SWS data files to a secure location such as a floppy disk or separate drive
space.
2. Remove the installed version of Actiware using the Add/Remove Programs

icon in Control Panel. An item labeled Actiware – Sleep or Actiware
– Rhythm should be listed here. Select it and click the Add/Remove button.
3. Follow the online instructions. Once the uninstall program has completed, all
program files and shortcuts will have been removed. Also, delete any desktop
icon shortcuts you created.
This completes the uninstall process for Actiware 3.1 or later.

or later
folder (commonly C:\Program Files\Actiware). Copy any .AWD, .AWS and
.SWS data files to a secure location such as a floppy disk or separate drive
space.
2. Remove the installed version of Actiware using the Add/Remove Programs

icon in Control Panel. An item labeled Actiware – Sleep or Actiware
– Rhythm should be listed here. Select it and click the Add/Remove button.
3. Follow the online instructions. Once the uninstall program has completed, all
program files and shortcuts will have been removed. Also, delete any desktop
icon shortcuts you created.
This completes the uninstall process for Actiware 4.0 or later.
Automatically Uninstalling Actiware / Actiware-CT 5.0 or later

1. Select Start > Control Panel > Add or Remove Programs.
2. Select Actiware Version 5 from the list. Click the Remove button.
3. When the confirmation pop-up window appears, select Yes to remove

Actiware.
This completes the uninstall process for Actiware 5.0 or later. Also, delete any
desktop icon shortcuts you created.
1-13
ActiReader Setup
Connecting ActiReader
ActiReader or an Actiwatch Reader is necessary to communicate with an
Actiwatch. Connection to a desktop computer or a laptop computer is very
similar to any other peripheral device. Upon starting Actiware, you will be
prompted to set up the COM port to recognize the ActiReader.
Note: Follow the recommendations supplied with your computer when

connecting peripheral devices. Most manufacturers suggest powering
down the computer while connecting hardware.
Computer with ActiReader
Note: If you have an earlier design of Actiwatch Reader, refer to

Actiwatch Reader later in this manual.

ActiReader
1. Connect the serial communication cable (supplied) to a COM port on your
computer. Actiware’s Select COM Port Wizard will assist in determining and
setting up the appropriate COM port. The COM port can be changed at
anytime.
2. Connect the other end of the communication cable to ActiReader.

ActiReader power must be ON and the red LED Power light should be
blinking. If the Power light is not blinking, the battery must be replaced (See
Replacing the ActiReader Battery later in this manual) or the external power
supply must be used.
• External Power Source

ActiReader can be powered from an external power source (supplied).
When plugged in, it will disconnect the battery to conserve it.
• Power ON/OFF switch
This switch will disconnect ActiReader from its power source, whether
AC or battery.
• POWER (Red LED)
Whether using external power or the internal battery, the red LED will
light when the Power switch is ON.
ActiReader Features
Power indicator
Aligned or Ready (Red LED)
(Green LED)
Communication
Pad
External
power input
RS-232 port
Power ON/OFF
1-15
• ALIGNED (Green LED)
When the Actiwatch is aligned properly and the communication wizard is
active, this green LED will light.
• Communication Pad
This slot ensures Actiwatch is placed properly. On the back of the
Actiwatch is a green dot in one corner. When the dot is aligned with the
green dot on ActiReader, the green LED on the ActiReader will light. This
indicates that communication between the two devices is possible.
• Serial Port
This is where the serial cable connects to ActiReader. The other end
connects to the COM port on the computer.
Note: The “back” of the Actiwatch is metal. The “front” or “face” of the
device is plastic.
Note: The ‘ALIGNED’ green LED will not light until appropriate portions
of the Communications Wizard are in use when the COM port is on (see
page 3-1, later in this manual).
Selecting the COM Port

1. Open the Actiware software program.
2. From the menu toolbar, select Communications > Select COM Port.
This will start the COM Port Wizard which will assist you in searching for an
available serial communication port on the computer (See illustration on next
page).
Start the COM Port Wizard

COM Port Wizard Welcome window
3. Click the Next button and the Wizard will search for available COM ports
When the search is completed, use your mouse to highlight the COM port to
which you connected the ActiReader.
1-17
Select the COM port from the list provided by the Automatic Search Results
4. Click Next to proceed to the Communications Port Test.
Note: The ActiReader must be functioning correctly and be connected to

the computer to complete the COM port selection. The Actiwatch must be
metal side up (Serial Number up) to successfully communicate with the
ActiReader.
5. Verify that ActiReader is connected correctly using the 3-point checklist.

If correct, select the Next button. You can also use the Skip Test button, but
the connection between the computer and ActiReader will not be tested.
If using a white Actiwatch Reader, click the appropriate button in the wizard or
see Actiwatch Reader later in this section.

3-point check list and Actiwatch Reader differences are embedded in the COM Port Wizard
If the Communications Test fails, a help window will appear to assist with
troubleshooting potential causes. Review each possible explanation.
When ActiReader is successfully connected to the computer, the Finished!

window will appear.
6. Select Finish to exit the wizard.
Upon completing the COM Port Wizard, you can configure an Actiwatch for
subject use or retrieve collected data (see Communications in Section 3 of this
manual).
1-19
Actiwatch Reader
Actiwatch Reader and ActiReader are very similar in their operation. Installation
and setup are the same.
However, please keep the following in mind when using the Actiwatch Reader:
• The Actiwatch Reader is white. The ActiReader is black.
• Instead of a slot for aligning the Actiwatch, place the Actiwatch over the
image and slide it up and down until the Ready LED is lit.
• The small dot on Actiwatch must be in the same corner as the small dot
on the reader.
• Researchers with laptop computers may switch the Actiwatch Reader to

Battery Power for proper function.
• If using battery power, you may need to replace the reader battery
periodically (see Replacing ActiReader Battery later in this section).
• As with the ActiReader, the COM port selection in the software must be
correct, and the communications wizard must be running, for the Ready
LED to be lit.
Actiwatch Reader top panel with orientation dot
Green dot
Actiwatch Reader
Power Toggle Switch
Serial I/O Port

ActiReader Battery Replacement Procedures
CAUTION! The black ActiReader model uses a 9V Lithium battery. The

white Actiwatch Reader uses a standard 9V battery. These batteries are
not interchangeable, and may result in damage to your device. Use of the
improper battery will void the warranty.
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 device.
Battery Replacement
1. Disconnect the AC electrical supply and set the Power toggle switch to OFF.
2. Turn the ActiReader over so the battery cover is facing up.
3. Slide the battery cover in the direction of the arrow.
4. Carefully remove the battery from the housing unit and gently disconnect
the battery terminals.
5. Replace the battery.
6. Slide the battery cover back into place on the ActiReader.
7. Set the Power toggle switch to the ON position.
8. Verify the red LED Power light is blinking.
WARNING! Do not dispose of lithium batteries in fire or flame. An

explosion may result. Only dispose in accordance with manufacturer’s
recommendation or local codes.
1-21
S ECTION
GETTING STARTED
2
WARNING! Actiware / Actiware-CT is for use only in a clinical, research,
or home care provider setting.
The workspace of the Actiware program is similar to many software applications.

Dockable windows give the user direct access to the Actiwatch or subject data
stored in the selected database. They also provide control over analysis viewing
and exports.
The Database Viewer and the Properties Viewer are docked at the left side of the
main Actiware window by default. The Actogram View toolbar is shown on the
right side of the main Actiware window.
Actiware databases are organized in a hierarchical fashion. The top level is the
subject level. The second level is the Actiwatch data for that subject. The third
level is for saved analyses of the Actiwatch data. You can navigate through this
hierarchy by clicking on the + (plus sign) or – (minus sign) buttons to the left of
the subject or Actiwatch data icons.
• Subjects are sorted by subject ID.

• Actiwatch Data entries are sorted by data collection start time.
• Analyses are sorted by saved name.
2-1
Main Window
Actiware workspace, full-window
The main Actiware window can be broken into three main sections:
• Toolbars
• Database Viewer
• Properties viewer
Toolbars
The Menu Bar is similar to most software applications. Keyboard shortcuts,

actuated by pressing the ALT key plus the hotkey letter, (identified by an
underscore) can be used to navigate through the toolbar menus.
2-2 Getting Started

The Standard toolbar, just below the Menu Bar, includes shortcuts to associated
functions within the Actiware software program. Hover your mouse over the icon
for a short text description.
Standard Toolbar Icons
Create A New Subject Edit Subject, Data, or Analysis
Configure My Actiwatch Show Audit Trail
Retrieve Data from My Actiwatch Open the Database Viewer
Import an .awd File Open the Properties Viewer
The following four icons determine how the data are shown in the Analysis
window.
Display Data as an Actogram Display the Data List
Display Statistics within an Interval Display Data as a Graph
Print an Actiware Report Create a New Analysis File
Export a Data File Open an Analysis File
Copy Export Text to the Clipboard Save an Analysis File
The Graph toolbar provides access to functions that are available only when
viewing a graph.
Print a Graph Copy Graph to the Clipboard
Edit the Graph Display Properties
2-3
The Actogram View toolbar is used for adjusting the viewing properties of an
Actogram, and is available only when an Actogram is present. Changes made to
this toolbar are immediately visible in the currently selected Actogram.
Actogram View Toolbar
• Days Displayed: controls how many days are displayed in the visible part
of the Actogram window. Use the scroll bar on the right of the Actogram to
see the remaining days. Pull down or type directly into this control to set the
number of days.
• Visibility: these buttons hide and show the data items in the Actogram:
2-4 Getting Started

• Activity Scale: adjusts the maximum value of activity counts displayed on
the Actogram. Pull down or type directly into this control to set the activity
scale.
• Illuminance Scale: adjusts the maximum illuminance value displayed on the
Actogram. Pull down or type directly into this control to set the scale.
• Light/Dark Bar: use these controls to show or hide the bar at the top of the
Actogram, to set the light on/light off time, or to set the light to all on (24
hours of light) or all off (24 hours of dark).
• Interval Legend: provides a convenient reminder of the color scheme used
for displayed intervals. Click the keyboard controls link to display quick
reminders on how to set intervals. See Setting Intervals later in this section.
To save your current Actogram View settings as default settings, click View >
Save Current Actogram View as My Default View. Or, to restore your default
view settings, click View > Restore My Default Actogram View.
Database Viewer
The Database Viewer is used to provide a hierarchical tree view of the data
in your currently selected database. Below is an example view from the
Demonstration Database that is provided with Actiware.
Database Viewer
2-5
Subjects, Actiwatch data, and Analyses are shown as indicated below:
Level Content
1st Level Subject Identity
(Subject) (Sorted
Alphabetically or
Numerically)
2nd Level Local Start Time

(Actiwatch Data) (Sorted by Date)
3rd Level Analysis Name

(Analysis) (Sorted
Alphabetically)
Commonly used functions can be accessed by right-clicking on an item in the

Database Viewer and using the popup menu.
Actiware automatically loads the last used database or when run for the first time,
the Demonstration Database. To create a new database, click File > Database >
New and use the Windows file selection to select a filename and location. Other
database functions (such as Open, Save As, Backup, and Export) can be accessed
from the File > Database menu.
The Database Viewer can be undocked or docked by clicking and dragging the
window title bar. In addition, it can be resized or closed. To show again, use the
View > Database Viewer menu.
2-6 Getting Started

Properties Viewer
The Properties Viewer displays information for the database item that is currently
selected in the Database Viewer; hence the Database Viewer and Properties Viewer
are linked.
Click the + or – next to the Subject, Actiwatch Data, or Analysis to expand or

collapse the properties related to that database item. Left-click on an item to see
a description of the property in the notes area at the bottom of the window. For
instance, the properties related to the Rest & Excluded Intervals analysis are
desplayed. Note that the Subject and Actiwatch data properties are also displayed.
Properties Viewer window
Items in the Properties Viewer can be edited by double-clicking the item.
The Properties Viewer can be undocked or docked by clicking and dragging the
window title bar. In addition, it can be resized or closed. To show again, use the
View > Properties Viewer menu.
2-7
Actogram
An Actogram is a graphic view of the rest/activity history of a subject. Data are
displayed in stackable 24-hour periods which allow the user to immediately
determine sleep/wake patterns.
The Actogram provides the ability to select periods of time, known as intervals,
and to provide statistics for these times of interest. (See Setting Intervals later in
this section.)
There are multiple ways to open an Actogram. The most direct way is:
1. In the Database Viewer, click the + sign next to a Subject to expand.
2. Click the + sign next to the Actiwatch Data record to expand.
3. Double-click on New Analysis. An Actogram will be displayed.
This process can be repeated for any analysis (such as Custom Intervals) shown
in the Database Viewer.
2-8 Getting Started

You can also open an Actogram by clicking the View > Actogram menu, or by clicking
the icon on the Standard toolbar at the top of the window.
Use the Actogram View toolbar (displayed on the right side of the window) to adjust the
view settings for the Actogram.
Note: The sleep/wake scoring algorithm is applied automatically to the activity in

the entire data set. Epochs scored as wake are indicated by a red mark below the
X axis, whereas epochs scored as sleep have no mark below the X axis.
2-9
Setting Intervals
Adding an Interval Selection to an Actogram
An interval is a user-defined selection of time that allows you to graphically

select and analyze data for statistical calculations. For calculation of statistics for
specific periods of time, it is necessary to select intervals and assign an interval
type to them. The Interval feature in Actiware provides a robust data selection,
exclusion and quantitative tool. The interval types that are available:
• Rest – user defined

• Sleep – automatically determined from Rest intervals
• Active – automatically determined from Rest intervals
• Excluded – user defined
• Forced Wake Score – user defined
• Forced Sleep Score – user defined
Rest intervals
These are intervals of data that contain periods of time when the subject activity
is low and the subject is likely to be at rest. They must be set by the user and are
indicated on the Actogram by light blue shading. Typically this will be used for
the In Bed Period. By setting a Rest Interval you are directing the program to
apply the Sleep Interval Detection algorithm for generating Sleep Periods.
This algorithm will use the first data point in the rest interval as the Bed Time
and the last data point as the Get up Time. From these points, the Sleep Onset
and Sleep End will be set using the Analysis parameter values that are indicated
on the Analysis tab of the Tools > Options window. Once you have set a Rest
Interval, a Sleep Interval will automatically be created within it.
2-10 Getting Started

Sleep Intervals
Data in these intervals represent periods of time in which the subject is likely to
be asleep. These intervals are created automatically by the program once a Rest
Interval has been set. They represent the period of time between Sleep Onset and
Sleep End but are not indicated by any shading.
Active Intervals
Data in these intervals represent periods of time in which subject activity

indicates that they are alert and engaged in physical activity. These intervals
contain all those data that are outside of Rest Intervals. Active Intervals are
created automatically when Rest Intervals are set. No shading is used to indicate
these intervals.
Excluded Intervals
Data in these intervals are excluded from all analytical calculations. These
intervals are designed for use when subjects remove the Actiwatch or for other
invalid periods of data. These must be set by the user and are indicated by dark
blue shading.
Custom Intervals
These are intervals of data that are of some interest for any reason. Typically
these are used for illuminance calculations when using an Actiwatch-L or
numerical rating scale values when using the Actiwatch Score. They may also be
used for assessing activity during specific periods of the day. They are indicated
on the Actogram by a blue bar above the activity data, and must be set by the
user.
Forced Wake
These intervals are periods of time for which the Sleep/Wake score has been
forced by the user to Wake. This is typically used if the subject is known to be
awake, but very inactive, or as an alternative to excluding data. Epochs included
in this type of interval are indicated by a magenta mark below the X axis of the
Actogram.
Forced Sleep
These intervals are periods of time for which the Sleep/Wake score has been
forced by the user to Sleep. This typically is used if the subject is known to
be sleeping but there is significant movement. Epochs included in this type of
interval are indicated by a gray mark below the X axis of the Actogram.
Note: Custom, Excluded, Forced Wake and Forced Sleep intervals can
be overlapped. However, due to the automatic creation of Sleep intervals,
Rest intervals cannot be overlapped. If you attempt to overlap Rest
intervals, they will be combined into one interval.
2-11
There are three ways to set intervals. The quick method uses the mouse and
hotkey combinations:
Quick Method
1. Hold down the CTRL key on the keyboard.
2. Click the left mouse button where you want the start of the interval to be.
Interval Start Time
3. While still holding down the CTRL key, click the right mouse button
where you want the end of the interval.
Interval End Time
If you set an interval flag in the wrong location and want to move it,
repeat the above process. Also, by holding down the CTRL key and the
mouse button, you can drag the flag to the precise location you want.
4. Using one of the following hotkey combinations, set the type of interval
you want:
CTRL + R Insert REST interval

CTRL + C Insert CUSTOM interval
CTRL + E Insert EXCLUDED interval
CTRL + W Insert Forced WAKE interval
CTRL + S Insert Forced SLEEP interval
The new interval will be automatically drawn in the Actogram display. See the
legend on the right side of the window (on the Actogram View toolbar) to see
how the intervals are indicated on the Actogram.
Note: During the interval creation process you can press the keyboard
Escape key to clear the markers.

Fine Control Method
To set your intervals graphically to the nearest epoch, use the following
procedure:
1. Click the left mouse button on the Actogram to place the epoch label.
2. Use the keyboard arrow keys (←, →, ↑, ↓) to move the epoch label to
the desired interval start time.
Close-up of Interval Markers on Actogram
3. To place the interval start marker, press one of the following keys based
on the interval type you want to create:
R Set REST interval start

C Set CUSTOM interval start
E Set EXCLUDED interval start
W Set Forced WAKE interval start
S Set Forced SLEEP interval start
4. Once again, click the left mouse button on the Actogram to place the
epoch label, and use the arrow keys to place the epoch label at the
desired interval end time.
5. To place the interval end marker, press one of the following hotkey
combinations based on the interval type you’re creating:
SHIFT + R Set REST interval end

SHIFT + C Set CUSTOM interval end
SHIFT + E Set EXCLUDED interval end
SHIFT + W Set Forced WAKE interval end
SHIFT + S Set Forced SLEEP interval end
If you set an interval flag in the wrong location and want to move it, repeat the
above process.
2-13
6. As with the Quick Method above, use one of the following hotkey
combinations to set the type of interval you want:
CTRL + R Insert REST interval

CTRL + C Insert CUSTOM interval
CTRL + E Insert EXCLUDED interval
CTRL + W Insert Forced WAKE interval
CTRL + S Insert Forced SLEEP interval
Note: During the interval creation process you can press the keyboard
Escape key to clear the markers.
Menu and Sleep Diary Methods
If you prefer to type in the date and time values for the interval start and end
times, such as if you have a patient sleep diary, use the following procedure:
1. Click Interval > Add Interval.
This will launch the Add Interval window.
2. Select the Interval Type
• Rest
• Excluded
• Custom
• Forced Sleep
• Forced Wake
3. Set the Interval Start Time (date and time).
You can type in the date or use the interactive calendar to select the date.
You can type in the time or use the arrows to scroll to the appropriate
time
4. Set the Interval End Time (date and time).
Note: If you want to create this interval for all days, check the Repeat for
all days check box. This will create an interval every 24 hours starting
with the interval start time, with the duration equal to the configured
interval.

5. Click the Add Interval(s) button to add the interval, or Close to cancel.
You can repeat steps 2 through 5 for each interval without closing the Add
Interval window.
Note: You can also click the right mouse button in the Actogram, or use
other sub-menus under the Interval main menu to set interval markers or
insert intervals.
Interval Quick Start Help
The Interval Quick Start Help message provides an overview of the interval
functions. To display this message, click the keyboard controls link on the
bottom of the Actogram View toolbar, or click Help > Quick Start > Interval
Selection.
Interval Quick Start pop-up message. To access, Help > Quick Start > Interval Selection
2-15
Removing Intervals
To remove a single interval simply click the left mouse button in the interval you
want to delete, then press the Delete key.
To remove all intervals, right click on the Actogram and select Clear All
Intervals (also accessible from the Interval menu)
To remove all intervals of a specific interval type, use the Interval menu, or the
corresponding keyboard shortcuts (such as CTRL + ALT + C to clear all custom
intervals).

Viewing Statistics
The Statistics Table is one of two main ways to display the calculated sleep/wake
output. Interval, activity, mobility, sleep, illuminance, and score statistics are
automatically calculated for intervals that are set by the user.
1. View > Statistics Table
Click on the tabs at the top of the window to view calculated statistics for
different types of intervals. Use the scrolling tools to move through the list of
intervals or to view different columns of statistics.
Statistics Table
Controlling the Content of the Statistics Table
1. Tools > Options
This will launch the Options pop-up window.
2-17
2. Statistics
Select the Statistics tab (mouse-click) to view the available statistic properties.
Check those statistics that you want to include. Actiware includes Select All,
Deselect All, and Restore Defaults buttons for ease of use.
3. Click OK to save your selections or Cancel to unaccept.
Your selections will appear in the Statistics Table and be included in exported and
printed data.
Tools > Options > Statistics
See Advanced Usage in Section 4 for statistic definitions.
Note: The selections that you make here will impact the content of
exported files and printed reports.

Exporting Data
Once you have added intervals and analyzed your data, you can export the
retrieved raw data or statistical results to a text file that can be easily loaded into
Microsoft Excel, FAST, or a database program of your choice.

There are three types of export files that can be created using Actiware:
Standard Individual Export File
This is a comma delimited ASCII text file (.csv) that can be opened directly by
Microsoft Excel. It contains the data and analysis results for one analysis.

To create this file, click File > Export menu or click the button on the
Standard toolbar. You will be prompted for a file name using the standard
Windows dialog box.
Note: The contents of the export file can be customized using the Tools >
Options window. Use the Statistics, Data List and Export tabs to select
what content you would like in the export file.
Instead of creating a file, you can copy the file contents directly to the Windows
clipboard by clicking Copy > Export Text. Then paste into your program of
choice using the Clipboard paste function (commonly CTRL + V keyboard
hotkey).
FAST™ Export File
This is a tab delimited ASCII text file (.txt) designed specifically for importing
into the Fatigue Avoidance Scheduling Tool™ Software. A short header, sleep/
wake scores, and per epoch time stamps for the currently selected analysis are
included in this export file.
To create this file, click File > FAST Export. You will be prompted for a file
name using the standard Windows dialog box.
FAST™ is a trademark of NTI, Inc.

2-19
Combined Export File

This is a comma delimited ASCII text file (.csv) that can be opened directly
by Microsoft Excel. It contains the data and analysis results for intervals
from multiple analyses. These analyses can be from any number of subjects or
Actiwatch data records in the currently opened database.
Use the Text File Export Batch Wizard, accessible from the Tools > Text File
Export Batch menu to create this file (or many Standard Individual Export
Files).
See Batch Export in Advanced Usage, Section 4, for details.
Note: Actiware-CT does not allow Copy > Export Text or File > FAST
Export because these are unsecured outputs that do not contain an
electronic or digital signature.

Print Report
You can generate a printed report of your Actogram and statistical results for the
currently selected analysis.

To generate the report, click File > Print Report, or click the button on the
Standard toolbar. You will be presented with a Windows printer dialog where you
can select the printer, number of copies, and paper orientation (such as Portrait or
Landscape).
Note: The contents of the printed report can be customized using the Tools
> Options window. Use the Statistics and Print Report tabs to select what
content you would like for the printed report.
2-21
New Subject
Once a database exists it can be populated with subjects and subject collected
data. To add or edit a subject, first open the database. Select File > Database >
Open, as described on the previous page.
To add a new subject to a database, do the following:
1. Click File > New Subject.
This will open a New Subject window to allow for the capture of demographic
data.
2. Fill in the three required fields: Identity, Date of Birth and Gender
For Identity, we suggest using a blind descriptor or nickname of the subject.

Notice that Age is automatically computed.
Important! Because you can import subjects from other databases,

Actiware allows more than one subject with the same ID. Therefore, you
need to be sure you choose a subject ID that does not already exist in the
currently open database.
3. If you desire, fill in the remaining fields.
For HIPAA considerations, these fields are optional.
When USA or Canada is entered into the Country field, a dropdown list for the
State/Province area will become available. Additionally, the Phone field will be
optimized for the (###) ###-#### format. To enter a non-US or non-Canadian
state code or phone number, enter the Country first.

Deleting/Hiding Subjects
For purposes of data tracking, you cannot delete subjects from a database. You
can hide them by checking the Hide Subject box. Once hidden, a subject will not
appear in the Database Viewer. Hidden subjects may be revealed by right clicking
in the Database Viewer and selecting View Hidden Subjects.
2-23
S ECTION
COMMUNICATIONS
3
The Actiware software is used to configure the Actiwatch device and retrieve
data from the Actiwatch through the use of the ActiReader.
To set up the ActiReader, see Installation and Setup in Section 1 of this manual.
Configure Actiwatch
Overview
This wizard will configure an Actiwatch for data collection. This wizard assumes
that the ActiReader or Actiwatch Reader is connected to the computer and the
appropriate COM port is selected. Please refer to Section 1 of this manual for
setting up the ActiReader and selecting a COM port.
The Configure Actiwatch Wizard will guide you through several windows. As
with other Actiware wizards, you can make changes at each window. You can
also travel between windows using the Back and Next buttons, or Cancel to
close the wizard.
Use the Show/Hide Actiwatch Details button to view additional information

associated with the watch.
CAUTION! The Configure Actiwatch wizard will delete all setup

information and data stored in the Actiwatch. To stop this wizard, select
the Cancel button. To retrieve data, proceed to Retrieve Data from
Actiwatch later in this section.
3-1
Configure Actiwatch Wizard Welcome window
Configure Configure Actiwatch

Actiwatch
1. Communications > Configure Actiwatch
This will launch the Configure Actiwatch Wizard.
2. Remove the wrist/foot bands from the Actiwatch (optional).
The bands may interfere with proper Actiwatch placement.
3. Place the Actiwatch on the reader.
The green dot on the metal side of the Actiwatch must align with the green dot
on the ActiReader. Verify that the metal side is facing up, the green dots are
adjacent and the green LED ‘ALIGNED’ light is on.
4. Click Next to continue.
The wizard will check the Actiwatch serial number and battery life. If a Low
Battery Warning appears, please choose one of the three options from the pop-
up window. If the warning does not appear, proceed to step 6.
• Change Battery—wizard will guide you through the battery replacement

process (see Actiwach Battery Replacement later in this manual).
• Changed Battery, update—wizard will update the database with the new
battery information.
• Ignore—wizard will ignore the Low Battery Warning.
3-2 Communications
Edit Subject Information
Select subject from the dropdown list or use the ‘New Subject’ button to add a new subject to the
database.
6. Select a current subject from the dropdown list and then click Edit Subject
to make updates.
When an existing subject is selected from the dropdown menu, the areas below
(Subject Name, Subject DOB, Age, and Gender) will pre-populate with the
information stored in the database.
Note: The subject must be in the current data file to be accessible from the
dropdown menu.
Click New Subject to configure Actiwatch for a new subject.
7. Click Next when you have completed editing/adding subject information.
3-3
Data Collection Setup
During the Data Collection Setup, you can configure the Actiwatch setup items,
including start time, epoch length, and time zone with a simple mouse click.
Expanded window displaying the Actiwatch Details.
Epoch length
The period of time Actiwatch will accumulate activity counts before saving the
sample to memory. Select the epoch length by clicking in this field. The choices
will appear sequentially.
When selecting epoch length:
• If actual recording time is in red, then the battery may need to be changed.
• Time zone selection should be where the data will be collected, not the
current time zone of the computer location.
• When configuring the Actiwatch for sleep analysis, use an epoch length of
2 minutes or less, otherwise sleep analysis statistics will not be calculated.
3-4 Communications
Epoch Length Number of Maximum Delay
Epochs per Day in Start Time
15 seconds 5760 5 days
30 seconds 2880 11 days
1 minute 1440 22 days
2 minutes 670 49 days
Note: For sleep analysis it is recommended you select an interval of one

minute or less. Data with sampling epochs of greater than two minutes
cannot be analyzed using Actiware-Sleep analysis.
Recording Time
Displays the time at which the activity monitor will fill its memory with samples
based on the epoch length selected.
Recording Time Table (for epochs > 0.25 minutes)

Memory 0.25 min 0.5 min 1 min 2 min 5 min 10 min 15 min
AW-16K 2.8 5.6 11.2 22.5 56.4 112.8 169.3
AW-64K 11.3 22.7 45.4 90.8 227 454 681
AW-L 3.7 7.5 15.1 30.2 75.7 151 225
AW-Score 5.6 11.2 22.4 44.9 112 224 336
NOTE: AW-L devices manufactured before July 1st, 1999 have 32K memory and shorter recording
times.
NOTE: Maximum battery life is 180 days for AW16, AW64, and AW-L, and 90 days for AW-Score.
8. Click Next when you have completed editing/adding data collection

information.
If you are configuring an Actiwatch-Score, continue below. If configuring an

Actiwatch-16/64 or Actiwatch-L, skip ahead to step 10.
Actiwatch-Score
If you are configuring an Actiwatch-Score, a Score Range window will appear

and you will now be required to set the minimum and maximum score ranges.
Set the ranges by typing in the numeric value (0-15) or use the scroll arrows.
3-5
Actiwatch-Score Alarm
Click the Enable Alarm Scheduling box and format the Score Alarms with the
following actions.
• Add Manual Alarm

• Add Recurring Alarm
• Delete Alarms (select item in list)
• Clear List
• Print List
After establishing the Actiwatch-Score Alarm schedule, you can print a listing.
Actiwatch-Score Alarm window
CAUTION! Do not remove the Actiwatch from the ActiReader during the
Configure Actiwatch Wizard process until instructed to do so.
The Configure Actiwatch process is in operation. When prompted, remove the

Actiwatch.
11. Click Finish to complete the Configure Actiwatch Wizard.
3-6 Communications
Retrieve Data from Actiwatch
Overview
This wizard will assist you in retrieving the physiological data from an Actiwatch
device. When the retrieval process is complete, the resulting data will be written
to your selected database for analysis and export.
This wizard assumes that the ActiReader or Actiwatch Reader is connected to the
computer and the appropriate COM port is selected. Please refer to Installation
and Setup in Section 1 of this manual.
CAUTION! The Actiwatch cannot collect data while on the reader.

Consequently, do not put the Actiwatch on the reader until you are ready
to stop data collection and retrieve the data from the Actiwatch.
Retrieve Data from Actiwatch Wizard Welcome window
3-7
Retrieve Retrieve Data from Actiwatch
Data from 1. Communications > Retrieve Data from Actiwatch.
Actiwatch
Start the Retrieve Data from Actiwatch Wizard. Click Next to continue.
2. Remove the wrist/foot bands from the Actiwatch (optional).
The bands may interfere with proper Actiwatch placement.
3. Place the Actiwatch on the reader.
The green dot on the metal side of the Actiwatch must align with the green dot
on the ActiReader. Verify that the metal side is facing up, the green dots are
adjacent and the green LED ‘ALIGNED’ light is on.
Actiware will communicate with the Actiwatch device and retrieve the data. If
you receive a Duplicate data, retrieve anyway message, you have the option to
abort the retrieve process by selecting the No button, or create a duplicate record
by selecting the Yes button and continue retrieving the data.
Duplicate data window
3-8 Communications
5. When the Retrieval Successful! message appears, click the OK button.
6. Check the Launch Actogram when the wizard finishes box to view the
Actogram data immediately.
7. Click the Finish button to exit the wizard.
Retrieve Data Complete window
Note: Actiware-CT requires the user to ‘Sign and Save’ the data by using a
Windows or Network username and password. Please contact your local
administrator with any issues or questions.
Note: Actiwatch-Score may occasionally make a short “chirping” sound

during communications. This is normal. DO NOT remove the device from
the reader until instructed.
3-9
3-10 Communications
S ECTION
ADVANCED USAGE
4
Actiware provides greater flexibility to researchers and clinicians when viewing
and analyzing data. Advanced users can take advantage of the Actiware Toolbars
to manipulate how the data is viewed and exported.
Items covered in this section:
• Program Options (Tools > Options)
• Data List
• Batch Export
• Import AWD files
• Graph
Your input is vital to us. Please explore the program fully and give us your
feedback. Please feel free to contact us with any questions or comments on this
software.
4-1
Program Options
Customize the Actiware software and data properties through the program
options window. Select Tools > Options from the main menu bar to access the
option tabs.
Tools > Options
Note: After you have finished making all of your changes in the options
window, click OK to accept or Cancel to not accept.
General Tab (Tools > Options > General)
Select the COM port from the dropdown menu. To reset all Help Window
reminders, check the Reset Reminder Notes button.
Tools > Options > General
4-2 Advanced Usage

Analysis Tab (Tools > Options > Analysis)
An analysis includes parameter settings and interval settings as inputs. Use the
Analysis tab for setting parameter values (see Section 2 for how to set intervals).
Definitions of each analysis parameter are given on the next few pages. You can
also see the definitions of each parameter on screen when running the Actiware
software by holding your mouse cursor over the parameter names on the left side
of the Analysis tab.
Active Analysis refers to the currently selected analysis, so the analysis parameter
settings shown in the Active Analysis frame are those of the currently selected
analysis.
New Analysis refers to a newly created analysis, so the analysis parameter settings
shown in the New Analysis frame are default values. These default values are
unique to each Windows logon username and are used each time a New Analysis
window is opened.
Click the << button to set Active Analysis parameter settings equal to New
Analysis parameter settings.
Click the >> button to set New Analysis parameter settings equal to those of the
Active Analysis.
Click the Restore Defaults button to reset to the factory released parameter
settings.
Tools > Options > Analysis
4-3
Analysis Parameter Definitions
Wake Threshold Selection
Selected level or method of setting the Wake Threshold. If Automatic is selected, the
Wake Threshold will be computed automatically based on activity data.
Wake Threshold Value

The number of activity counts used to define wake. Detail: Level of activity that is
compared to a value (x) generated by the Actiware sleep algorithm for each epoch. If
(x) is above the Wake Threshold, then the epoch is scored as wake. The higher the Wake
Threshold, the fewer the number of epochs scored as wake (See Appendix A for further
information).
Sleep Interval Detection Algorithm

This determines the basis for calculating sleep onset and sleep end. The first option
uses the number of minutes scored as immobile. By selecting this option, the parameter
settings for epochs for sleep onset and sleep end can be edited. The second option uses
a number of epochs scored as sleep. By selecting this option, the parameter settings for
immobile minutes for sleep onset and epochs for sleep end can be edited. Note: This is a
means of automatically setting sleep onset and sleep end intervals, not rest intervals.
Immobile Minutes for Sleep Onset

After the start of each rest interval, the start of each sleep interval will be automatically
set to the first epoch of the first section of consecutive epochs “THIS” many minutes
long with all but one epoch in the section scored as immobile. Note: This parameter is
only applied if the Immobile Minutes option is selected as the sleep interval detection
algorithm.
Immobile Minutes for Sleep End

Prior to the end of each rest interval, the end of each sleep interval will be automatically
set to the last epoch of the last section of consecutive epochs “THIS” many minutes
long with all but one epoch in the section scored as immobile. Note: This parameter is
only applied if the Immobile Minutes option is selected as the sleep interval detection
algorithm.
Epochs for Sleep Onset

After the start of each rest interval, the start of each sleep interval will be automatically
set to the first epoch of the first section of consecutive epochs scored as sleep “THIS”
many epochs long. Note: This parameter is only applied if the Sleep Epochs option is
selected as the sleep interval detection algorithm.
Epochs for Sleep End

Prior to the end of each rest interval, the end of each sleep interval will be automatically
set to the last epoch of the last section of consecutive epochs scored as sleep “THIS”
many epochs long. Note: This parameter is only applied if the Sleep Epochs option is
selected as the sleep interval detection algorithm.
Actogram Start Hour

The hour at which Actogram rows and daily intervals begin. This setting affects daily
interval statistics.
Illuminance Threshold
Level of illuminance, in lux, that is compared to the intensity of illumination the
Actiwatch-L is exposed to, for the purpose of calculating the Time Above Illuminance
Threshold statistic for given time intervals (Actiwatch-L only).
4-4 Advanced Usage

Actogram Tab (Tools > Options > Actogram)
These are the default Actogram viewing properties. Each time an Actogram is
opened, it will be displayed with these properties. Adjusting these properties
will not affect any open Actograms. To view the changes, close and reopen the
Actogram.
Click the Restore Defaults button to reset to the factory released settings.
Tools > Options > Actogram
4-5
Statistics Tab (Tools > Options > Statistics)
Select the items of data displayed from the analysis. Changes made here will
impact exported and printed data, and the statistics table window contents. Place
your cursor over an item to get a brief definition of that item.
Click Select All to include all items in your statistical analysis. Click Deselect
All to remove all items from your statistical analysis. Click the Restore Defaults
button to reset to the factory released settings.
Tools > Options > Statistics
See Appendix B for a definition of each statistic.
4-6 Advanced Usage

Data List Tab (Tools > Options > Data List)
Select the columns to be displayed in the Data List window. Changes made on
this tab will impact the content of exported files and printed reports.
Click Select All to include all items in the Data List. Click Deselect All to
remove all items from the Data List. Click Restore Defaults to return the settings
to the factory presets.
Changes made in the Tools > Options > Data List window will be immediately
displayed in the View > Data List window.
Tools > Options > Data List
4-7
Export Tab (Tools > Options > Export)
Select the items you want to include in your export file (also applies to the Copy
> Export Text to windows clipboard function in the non-CT version of Actiware).
Use the Statistics tab to select individual statistics. Use the Data List tab to
select individual columns of data.
Click Select All to select all of the types of data. Click Deselect All to uncheck
all of the types of data. Click Restore Defaults to return the settings to the
factory presets.
Tools > Options > Export
4-8 Advanced Usage

Print Report Tab (Tools > Options > Print Report)
Select the items you want to include in your printed report. Click the Full
Header box to include a first page of header information (recommended). Click
the Actogram box to include the Actogram graphic in the report. You can select
the number of Actogram days to print per page. Click the Statistics box (and sub-
boxes) to include statistics for various types of intervals (by default the report
will include Summary Statistics only). Use the Statistics tab to select individual
statistics.
Click Select All to select all of the types of data. Click Deselect All to uncheck
all of the types of data. Click Restore Defaults to return the settings to the
factory presets.
Tools > Options > Print Report
4-9
Data List
1. View > Data List
You have selected to view a listing of the currently active data as a function of
time (epoch-by-epoch).
2. Click the Epoch-by-Epoch List tab or the Marker/Score List tab to view
the data list for that type.
Use the scroll bars to move up and down each List and to pan across data
columns as necessary. You may want to maximize the window size by clicking
the ‘Maximize’ button in the upper right corner.
View > Data List
4-10 Advanced Usage

Text File Batch Export
This option is used when you want to export data from multiple analyses for the
currently open database. You can elect to send these data to individual text files
or to the same composite file.
Text File Export Batch Wizard Welcome window
1. Tools > Text File Export Batch
This will launch the Export Batch Wizard. Confirm that the currently active
database is the one you want to export from.
2. Click Next.
Select the type of output you require (individual files for each analysis, or a
combined file for multiple analyses).
Select destination of the exported data
4-11
3. Click Browse.
Use this button to determine the destination for any export output using the
Browse button and the Windows File Dialog.
4. Click the Options button to make any changes.
5. Click Next.
6. Select the data that you want to include in the export file by checking the
boxes.
Select data to export
Note: The controls for this window are hierarchical. If you select a
subject, or Actiwatch data entry all analyses associated with that subject
or Actiwatch data set will be included in the export file.
Note: Hidden subjects are shown in the display.
Hidden data is indicated by the red circle and the diagonal line.
4-12 Advanced Usage

7. Suppress Errors Messages box.
When this box is checked, you will not be prompted if an error occurs during the
batch process. If a file alrady exists, an automatic filename will be created.
8. Overwrite Existing Files box.
Indicate if you want to overwrite existing export file(s) without being prompted.
9. Click Next to process your data and create the export.
More options are available when using the Text File Export Batch Wizard
10. Click OK when the batch process is completed.
If any errors occur, you have the option to view the log file for details. You can
also Restart the batch process. If you restart the process you may choose to
overwrite the existing file or rename the file.
11. Click Finish to complete the Export Batch Wizard.
Batch Completed! pop-up window
4-13
Import AWD Files
Note: .AWS files cannot be imported. Only .AWD (Actiwatch) files can be
imported.
Import AWD
You can import data files collected with previous versions of Actiware (Actiware-
Sleep/Rhythm v3.4 and earlier).
1. Left mouse click to highlight the subject you want to import the AWD file to.
If you do not already have a subject created, use File > New Subject menu.
2. Click File > Import AWD.
File > Import AWD
3. Use Windows File Dialog to Browse to the location of the AWD files.
Select the file and click OK to import. When the file is successfully imported
a pop-up window will appear.
Note: The identity from the AWD file is not imported. You must select or
create the correct subject when importing.
4-14 Advanced Usage

4. Click Yes to edit the Actiwatch Data properties or click No to bypass.
5. The data is ready for analysis.
Edit Actiware Data
4-15
Graph
View View
The Actiware toolbars provide many new features to assist you with the data.
Graph
1. View > Graph
This is the Graph window for viewing Actiwatch data along a single axis.
View > Graph
Graph Icons
2. View > Toolbars > Graph
When viewing a graph, the Graph Icons are available in the standard toolbar.
These icons allow you to
1. Print the graph.

2. Edit Graph Display Properties.
3. Copy a picture of the graph to the Windows Clipboard.
4-16 Advanced Usage

Graph Help
The Graph Help window provides useful information when using the Graph
view.
Edit Graph Display Properties

1. Tools > Edit Graph
This more advanced feature allows you to edit the Graph GUI, display and
printing features, and plotting parameters of the graph.
4-17
4-18 Advanced Usage
S ECTION
Clinical Trials
5
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.
5-1
Authenticate 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.
Security Log on window
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.

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.
5-2 Clinical Trials

Audit Trail
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.
Results of right-clicking on a saved analysis and selecting the Audit Trail menu item.
5-3
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.
Highlight the row to see prior and new values.
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.
Audit Trail window provides the ability to view all previous revisions of the record.
5-4 Clinical Trials

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.
Audit Actogram window
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.
5-5
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 file is preserved and signed/hashed

separately.
5-6 Clinical Trials

Database Validation and Back-up
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.
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.
5-7
5-8 Clinical Trials
A ppendix
SLEEP/WAKE ANALYSIS
A
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-1
30-second
sampling
epochs
1-minute
sampling
epochs
2-minute
sampling
epochs
A-2 Sleep/Wake Analysis

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 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
Threshold below.
Values
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-3
A-4 Sleep/Wake Analysis
A ppendix
STATISTIC DEFINITIONS
B
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-1
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)

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
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-2 Statistic Definitions

Scored Total Wake Time
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

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

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-3
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

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
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.

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
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
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-5
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
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
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
Standard Deviation of Scheduled Scores

The standard deviation of all Scheduled Score Values [that are not manually

A ppendix
ACTIWATCH HARDWARE
C
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-1
Actiwatch Accelerometer
Details 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-2 Actiwatch Hardware

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
reconfigure 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 firmly 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-3
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.

ACTIWATCH-L
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.
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:
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
C-5
Recommended Calibration
We recommend factory calibration of Actiwatch-L every 12 months. Contact
Mini Mitter Technical Support for information.
Influences
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

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-7
ACTIWATCH-SCORE
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 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.

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-9
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.
Annunciator 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.
Note: After setup, the annunciator is reset to On.
Marker 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
Button and off.

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-11
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
entered by day
10 sec 20 sec 30 sec
Score events
5 139 days 123 days 110 days

Actiwatch Battery Replacement Procedure
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.
CAUTION! The latest Actiwatch-Score models (serial numbers having

a D prefix, e.g. Dxxxxx) use a CR 2025 battery. Earlier Actiwatch- Score
models (serial numbers having an N prefix, 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-13
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.

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-15
• 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.
1 3
4 2
CAUTION! DO NOT over tighten the screws. They can be easily stripped.

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-17
A ppendix
SPECIFICATION
D
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-1
Specification for Actiwatch-16/64
ENVIRONMENTAL
Operating Storage
Temperature 0° C to 40° C -10° C to 50° C
(32° F to 104° F) (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 Internally powered
Shock:
Degree of Protection Against Type BF Applied Part
Electric Shock:
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 Water tight to a depth of 1 meter for 30 minutes
Ingress of Water: IEC Standard IPX7
D-2 Specifications
FUNCTIONAL
Parameter Value Note

Accelerometer sensitivity 0.05 g-force
Accelerometer bandwidth 3 Hz to 11 Hz
Sampling epochs 15 and 30 seconds, Actiware-PLM software
1, 2, 5, 10, and 15 minutes 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
IEC60601-1-1 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety
Requirements for Medical Electrical Systems
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-3
Specification for Actiwatch-Score
ENVIRONMENTAL
Operating Storage
(32° F to 104° F) (14° F to 122° F)
PHYSICAL
Case Material: Glass-filled Nylon
ELECTRICAL
Battery Type: CR 2025

Shock:
Electric Shock:
Electromagnetic The device meets the
Compatibility: requirements of EN 60601-1-2,
second edition (2001).
Fuses: There are no user-replaceable
fuses.
Degree of Protection Against Dripping and light splashing of
Ingress of Water: liquids
IEC Standard 60529 IPX2
D-4 Specifications
FUNCTIONAL

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

DISPOSAL
D-5
Specification for Actiwatch-L
ENVIRONMENTAL
Operating Storage
(32° F to 104° F) (14° F to 122° F)
PHYSICAL
Case Material: Glass-filled Nylon
ELECTRICAL
Battery Type: CR 2025

Shock:
Electric Shock:
Electromagnetic The device meets the
Compatibility: requirements of EN 60601-1-2, second
edition (2001).
Degree of Protection Against Waterproof / Watertight to a depth of 1
Ingress of Water: meter for 30 minutes
IEC 60529 IPX7
DISPOSAL
D-6 Specifications
FUNCTIONAL

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

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-7
Specification for ActiReader
ENVIRONMENTAL
Operating Storage
(32° F to 104° F) (14° F to 122° F)
PHYSICAL

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 V AC , 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
Shock:
Electric Shock:
Sterile Non-Sterile
Electromagnetic Compatibility: The device meets the
requirements of EN 60601-1-2, second edition
(2001).
Power Supply Model Nos: DSA-0151D-12
D-8 Specifications

DISPOSAL
D-9
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
D-10 Specifications
A ppendix
EMC INFORMATION
E
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 Group 1 This device uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B This device is suitable for use in all

CISPR 11 establishments, including domestic
establishments and those directly connected
Harmonic emissions Class A to the public low-voltage power supply
IEC 61000-3-2 network.
Voltage fluctuations/ Complies

Flicker emissions
IEC 61000-3-3
E-1
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity IEC 60601 Test Compliance Electromagnetic Environment -

Test Level Level Guidance
Electrostatic ±6V contact ±6 kV contact Floors should be wood, concrete or

Discharge ceramic tile. If floors are covered with
(ESD) ±8V air ±8 kV air synthetic material, the relative humidity
should be at least 30%.
IEC 61000-4-2
Electrical fast ±2kV for power ±2kV for supply Mains power quality should be that of a
Transient/burst supply lines mains typical home or hospital environment.
±1kV for input/
IEC 61000-4-4 output lines ±1kV for input/ It is noted certification to IEC 60601-
output lines 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 ±1kV differential ±1kV differential Mains power quality should be that of a
mode mode typical home or hospital environment.
IEC 61000-4-5
±2kV common ±2kV common
mode mode
Voltage <5% UT <5% UT Mains power quality should be that of a

dips, short (>95% dip in UT ) (>95% dip in UT ) typical home or hospital environment.
interruptions for 0.5 cycle for 0.5 cycle
and voltage 40% UT 40% UT
variations on (60% dip in UT) (60% dip in UT)
power supply for 5 cycles for 5 cycles
input lines 70% UT (30% 70% UT (30%
dip in UT) for 25 dip in UT) for 25
IEC 61000-4- cycles cycles
11 <5% UT (>95% <5% UT (>95%
dip dip in UT) for 5
in UT) for 5 sec sec
Note: UT is the a.c. mains voltage prior to application of the test level.
E-2 EMC Information

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity test IEC 60601 Compliance Electromagnetic Environment -

Test Level Level (FDA) Guidance
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of a typical location
magnetic field in a typical home or hospital environment.
IEC 61000-4-8
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

Conducted RF 3 Vrms 3 Vrms is obtained recognizing that interruption
IEC 61000-4-6 150 kHz to 80 of the download of data to the reader due
MHz 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.
Radiated RF 3 V/m 3 V/m Interference that would interrupt a download
IEC 61000-4-3 80 MHz to is anticipated to be of short duration such
2.5 GHz that the subsequent download would be
successful.
Recommended Separation Distance
d = 1. 2 P
d = 1. 2 P 80 MHz to 800 MHz
d = 2 .3 P 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-3
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 reflection from
structures, objects and people
a Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field 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.
b Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
E-4 EMC Information

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 Separation Distance According to Frequency of Transmitter

Maximum (m)
Power Output 150 kHz to 80 80 MHz to 800
of Transmitter MHz
800 MHz to 2.5 GHz
MHz
(W) d = 2.3 P
d = 1.2 P d = 1.2 P
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-5
E-6
910-0025-01 Rev B
JW 12/08/2006

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Instruction Manual

Actiwatch Communication and

Actiwatch-16, -64, -Score, -L

Actiwatch -L / Actiwatch -Score ® ®

Actiware 5.0 / Actiware -CT 5.1 ® ®

Actiwatch Communication and

© 2006 Respironics, Inc. and its affiliates. All rights reserved.

a) Commencement of Warranty – The warranty period begins on the date of delivery.

SOFTWARE LICENSE AGREEMENT

14. Specific Exceptions.

Contacting Technical Support

Mailing and Mini Mitter, a Respironics Company

Telephone (800) 685-2999 (US and Canada only)

Fax (541) 322-7277

Web site www.minimitter.com

INTRODUCTION AND SETUP .....................................................................................................................................1-1

GETTING STARTED . ...................................................................................................................................................2-1

ADVANCED USAGE ....................................................................................................................................................4-1

SLEEP/WAKE ANALYSIS . .......................................................................................................................................... A-1

INTRODUCTION AND SETUP

● Manage subject (patient) information

● Configure Actiwatch devices for data collection

● Retrieve clinical data from Actiwatch devices

● View clinical data

● Analyze data for sleep parameters and rhythmicity

● Export raw data or statistics for external analysis or archive

Actiware-CT is also capable of clinical trial tracking and auditing in accordance

This system is designed to conform to the following standards:

• IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements

1-2 Introduction and Setup

• Operation of the device may be adversely affected by:

• Do not use this device in the presence of a flammable anaesthetic mixture

• If you notice any unexplained changes in the performance of this device, if

• ActiReader Only - To avoid electrical shock, disconnect the AC power

1-4 Introduction and Setup

Type BF Applied Part

Canadian/US Safety Certification

Protected against vertically falling water drops when

Alignment Indicator (ActiReader)

European Declaration of Conformity (conformance to

System • Microsoft Windows® 2000 or XP operating system

• 512 MB RAM; 128 MB RAM minimum requirement

• 300 MB or higher recommended; 50 MB required for installation

• Super VGA (1280 x 1024) resolution video adapter and display

• Keyboard and Microsoft Mouse or compatible pointing device

• 9-pin or 25-pin RS-232 communications serial port

• UL 1950, IEC 60950, or EN60950 approved computer

Note: Actiware / Actiware-CT was created for use with Windows®.

Note: Before beginning the installation procedure, make sure that no

1-6 Introduction and Setup

CAUTION! Before proceeding, back up any previously gathered data

Installing Actiware / Actiware-CT

Note: You must be a member of the Administrator’s group in order to

Note: Users of Actiware (Research Version) must be a member of the

2. Select Install Actiware Version 5 from the menu.

End-User License Agreement

Important! The Software License Agreement must be accepted before

Note: Actiware-CT requires the user to authenticate using their Windows

1-8 Introduction and Setup