Certification Exhibit FCC ID: JIAAWR1 IC: 6041A-AWR1 FCC Rule Part: 15.209 IC Radio Standards Specification: RSS-210 ACS Report Number 08-0085 - 15C Manufacturer: Mini Mitter Company, Inc. Model(s): ActiReader Manual (Part 1 of 3) 5015 B.U.
Instruction Manual Actiwatch Communication and Sleep Analysis Software Actiware® 5.0 and Actiware-CT 5.
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.
Mini Mitter, a Respironics Company WARRANTY POLICY 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. 1.
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.
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.
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.
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 Shipping Address Telephone Fax Mini Mitter, a Respironics Company 20300 Empire Avenue, Bldg.
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Table of Contents Software License Agreement.........................................................................................................................................iv Contacting Technical Support.......................................................................................................................................vii INTRODUCTION AND SETUP .....................................................................................................................................
S ECTION 1 INTRODUCTION AND SETUP 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 auditi
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.
Warnings and Cautions CAUTION! US federal law restricts this device to sale by or on the order of a physician. WARNING! A warning indicates the possibility of injury to the user or operator. WARNING: • The provider should read and understand this entire manual before using this device. • This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professional’s instructions regarding the use of this device.
CAUTION! A caution indicates the possibility of damage to the device. Note Places emphasis on an operating characteristic. CAUTION: • Repairs and adjustments must be performed by Mini Mitter/Respironics authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage. • Dispose of these devices in accordance with local regulations. Note: Additional Warnings, Cautions, and Notes may appear throughout this manual.
Symbols Symbol Meaning Attention, consult accompaning documents DC Power Type BF Applied Part Canadian/US Safety Certification IPX2 Protected against vertically falling water drops when enclosure tilts up to 15 degrees.
Installation Prerequisites System Requirements • Microsoft Windows® 2000 or XP operating system Windows XP Professional required for Actiware-CT • 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) • Keybo
First Time Installation If this is the first time Actiware will be installed, please continue to Installing Actiware later in this section. 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.
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.
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-Z0WRG4ZBJXKT-NC20CA When you receive your activation key, cut and paste the Registered User’s e-mail and key as shown and press Enter Key.
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 (ActiwareRhythm, Actiware-Sleep, RhythmWatch, SleepWatch). Select the Actiware version from the list.
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.
Manually Uninstalling Actiware-Rhythm or Actiware-Sleep 4.0 or later 1. Using Windows Explorer, review the contents of the Actiware installation 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.
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.
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.
• 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.
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.
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.
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.
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.
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.
1-22 Introduction and Setup
