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 3 of 3) 5015 B.U.
S ECTION 5 Clinical Trials Actiware-CT (clinical trial) software is designed especially for customers who are concerned about data security and compliance with 21 CFR Part 11. New features have been included in the software that ● Restrict access to only authorized users. ● Embed electronic signatures in data files. ● Secure data files with digital signatures. ● Detect and report unauthorized access. ● Record all changes to subject and data properties, as well as analysis settings and results.
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.
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.
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 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.
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.
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.
5-8 Clinical Trials
A ppendix A SLEEP/WAKE ANALYSIS 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.
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 11:59 12:00 12:01 12:02 100 42 20 13 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.
A-4 Sleep/Wake Analysis
A ppendix B STATISTIC DEFINITIONS 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).
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.
Scored Total Wake Time (The total number of epochs between the Start Time and the End Time of the given interval scored as WAKE by Actiware software [or manually set as WAKE by the practitioner using Actiware software]) multiplied by the Epoch Length in minutes (so the Scored Total Wake Time is in minutes).
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.
Total Illuminance Exposure (The sum of all valid illuminance data, in Lux, from an Actiwatch-L [see Total Invalid Time (Illuminance), below] for all epochs from the Start Time to the End Time of the given interval) multiplied by the Epoch Length in minutes (so the Total Illuminance Exposure is in Lux-minutes). Average Illuminance The average of all valid illuminance data for all epochs from the Start Time to the End Time of the given interval.
Number of Scheduled Scores The number of Scheduled Scores entered by the subject while wearing Actiwatch-Score, and not manually excluded later by the practitioner using Actiware software, from the Start Time to the End Time of the given interval. Number of No Responses The number of No Responses to Scheduled Scores (that are not manually excluded by the practitioner using Actiware software), from the Start Time to the End Time of the given interval.
A ppendix C ACTIWATCH HARDWARE 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.
Actiwatch Details Accelerometer The shape of the accelerometer makes it most sensitive to motion changes in certain orientations. However, it is an omnidirectional sensor, resulting in sensitivity to motion changes in all directions. The Actiwatch stores an integration of movement (including directional aspects) as activity “counts”. The sampling frequency is 32 Hz.
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.
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.
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.
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.
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.
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. ActiwatchScore is unique in that the marker button allows the user to “score” an event.
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.
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.
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.
Battery Life The battery life for Actiwatch-Score is primarily affected by: • The number of score entries (whether prompted by an alarm or not) Score events entered by day • 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): C-12 Actiwatch Hardware Time taken to enter score 5 10 20 40 10 sec 139 days 123 days 100 days 73 days 20 sec 123 days 100 days 73 days 47
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.
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.
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.
• 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.
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.
C-18 Actiwatch Hardware
A ppendix D SPECIFICATION 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.
Specification for Actiwatch-16/64 ENVIRONMENTAL Temperature Relative Humidity Atmospheric Pressure Operating Storage 0° C to 40° C (32° F to 104° F) 0 to 95% RH -10° C to 50° C (14° F to 122° F) 0 to 95% RH 500 to 1060kPa (5600 feet to sea level) PHYSICAL Dimensions: Weight: Case Material: Frame and Battery Cover: Standard Wrist Band: 29 L x 37 W x 12 H (mm) 16 grams 22 grams Polyurethane/Polyester Alloy Titanium Nylon with buckle w/o band with standard band ELECTRICAL Battery Type: Battery Life:
FUNCTIONAL Parameter Value Accelerometer sensitivity Accelerometer bandwidth Sampling epochs 0.05 g-force 3 Hz to 11 Hz 15 and 30 seconds, 1, 2, 5, 10, and 15 minutes Memory 16 or 64 kB Note Actiware-PLM software configures Actiwatch to sample at 2 second epoch length.
Specification for Actiwatch-Score ENVIRONMENTAL Temperature Relative Humidity Atmospheric Pressure Operating Storage 0° C to 40° C (32° F to 104° F) 0 to 95% RH -10° C to 50° C (14° F to 122° F) 0 to 95% RH 500 to 1060kPa (5600 feet to sea level) PHYSICAL Dimensions: Weight: Case Material: Frame and Battery Cover: Standard Wrist Band: 37 L x 35 W x 12 H (mm) 19 grams 25 grams Glass-filled Nylon Titanium Nylon with buckle w/o band with standard band ELECTRICAL Battery Type: Battery Life: CR 2025 3
FUNCTIONAL Parameter Value Accelerometer sensitivity Accelerometer bandwidth Sampling epochs 0.
Specification for Actiwatch-L ENVIRONMENTAL Temperature Relative Humidity Atmospheric Pressure Operating Storage 0° C to 40° C (32° F to 104° F) 0 to 95% RH -10° C to 50° C (14° F to 122° F) 0 to 95% RH 500 to 1060kPa (5600 feet to sea level) PHYSICAL Dimensions: Weight: Case Material: Frame and Battery Cover: Standard Wrist Band: 29 L x 37 W x 11 H (mm) 16 grams 22 grams Glass-filled Nylon Titanium Nylon with buckle w/o band with standard band ELECTRICAL Battery Type: Battery Life: CR 2025 3 Mon
FUNCTIONAL Parameter Value Note Accelerometer sensitivity Accelerometer bandwidth Sampling epochs Memory Sensor Type Spectral response Wavelength window Minimum illuminance sensitivity Maximum illuminance sensitivity Linearity 0.05 g-force 3 Hz to 11 Hz 15 and 30 seconds, 1, 2, 5, 10, and 15 minutes 64 kB Photodiode CIE Y-curve 330 to 720 0.1 150,000 2% Resolution 2% of lux value On-board sensor Approximate nm lux lux Typical from 0.
Specification for ActiReader ENVIRONMENTAL Temperature Relative Humidity Atmospheric Pressure Operating Storage 0° C to 40° C (32° F to 104° F) 0 to 95% RH -10° C to 50° C (14° F to 122° F) 0 to 95% RH 500 to 1060kPa (5600 feet to sea level) PHYSICAL Dimensions: Weight: Case Material: 114 L x 72 W x 34 H (mm) 158 grams ABS plastic ELECTRICAL Data Port Battery Type: Battery Life: AC Voltage Source: DC Voltage Source: AC Current: DC Current: Protection Against Electric Shock: Degree of Protection Ag
STANDARDS COMPLIANCE Test Standard Description IEC60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests Information Technology Equipment - Safety - Part 1: General Requirements IEC60601
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).
A ppendix E EMC INFORMATION Guidance and Manufacturer’s Declaration – Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 This device uses RF energy only for its internal function.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge (ESD) ±6V contact ±6 kV contact ±8V air ±8 kV air Floors should be wood, concrete or ceramic tile.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
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.
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.
E-6
910-0025-01 Rev B JW 12/08/2006
FCC and Industry Canada Compliance Information Warning: Changes or modifications to this device not expressly approved by Respironics/Mini Mitter could void the user’s authority to operate the equipment. FCC: NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.