PHILIPS Respironics Actiwatch Spectrum PRO User manual
Actiwatch
Technician Guide
2
Intended Use
The Actiwatch devices are wrist-worn activity data recorders that can record data relevant to
circadian rhythms and sleep parameters in any instance where quantifiable analysis of physical
motion is desirable.
In addition, the Actiwatch Spectrum PRO device has a built-in score pad that allows the
subject to subjectively assign and enter a numeric score.The score pad can be used as a
substitute or in addition to the traditional patient diary used in conjunction with activity data
recording.
Caution! US Federal law restricts this device to sale by or on the order of a physician.
Warnings
A warning indicates the possibility of injury.
• Discontinue use if the device wearer shows signs of skin reddening or inflammation.
• If the device becomes damaged, discontinue use and return it for replacement or repair.
• Do not connect the device to a computer while worn or handled by a patient.This could
......result in an unsafe condition.
Cautions
A caution indicates the possibility of damage to the device.
• Spectrum PRO and Plus devices should only be charged within the operating temperature
....range of 5° C (41° F) to 30° C (86° F).
• Do not attempt to take the device apart. No user-serviceable parts are inside.
......Unauthorized service or tampering could invalidate the warranty or result in costly damage.
• Use only with UL 60950-1, IEC 60950-1, EN 60950-1, or CSA C22.2#60950-1 certified
......IT equipment.
• Use of non-original manufacturer-approved accessories may affect EMC performance and
......should be avoided.
• Mobile RF communications equipment can affect performance of this device.
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System Contents
Your package may include some or all of the following for your appropriate system.
Spectrum PRO or Plus USB Cable
Actiware Software
Replacement Watchbands and Tool
Wearer Guide (10 pack)
Technician & Clinician Guides
Actiwatch Spectrum Communication Dock
Actiware Software
Replacement Watchbands and Tool
Wearer Guide (10 pack)
Technician & Clinician Guides
Actiwatch 2 Communication Dock
USB Wall Plug with Cable
Actiware Software
Replacement Watchbands and Tool
Wearer Guide (10 pack)
Technician & Clinician Guides
Symbol Key
The following symbols may appear on the device or in this manual.
USB Connection IP27 Protected against the effects of
temporary immersion in water
DC Power Type BF Applied Part
Consult Accompanying
Documents
Separate collection for electrical
and electronic equipment per
EC Directive 2002/96/EC.
Prescription Required
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Preparing Actiwatch for a Patient
1. Launch the Actiware software application. (See the Software Installation Guide for
system requirements and complete installation instructions.)
2. Open the database where the data will be stored by selecting File > Database > Open.
Then, select the desired database.
• You can create a new database by selecting File > Database > New...
3. For each new patient, create a new patient record with a unique Subject ID in the
database by selecting File > New Subject...
4. Connect your device to your computer with the provided USB cable as shown below.
Spectrum PRO and Plus
Actiwatch 2 and Actiwatch Spectrum
Note: The connection port on the device and communication dock is for a USB connection only and
should not be used for any other purpose.
5. Within the Actiware software, click the Console button ( ) to open the Actiwatch
Console.
6. Select the device you wish to configure.
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7. Click the Congure button at the bottom of the screen.
8. Select the desired configuration options from the communications wizard.
Note: For more information about configuration options, see Actiware’s online help.
9. After configuration is complete, confirm that the Actiwatch is clean and fully charged.
10. Show the patient the proper way to wear the device. Deliver the device to the patient
with the Wearer Guide.
Retrieving Actiwatch Data
1. Connect your device to your computer as shown on the previous page.
2. Within the Actiware software, click on the Console button ( ).
3. Select the appropriate device.
4. Then, click on the Retrieve button at the bottom of the window to retrieve the patient
data and store it in the database.
Recharging the Battery
Note: Only Actiwatch 2, Spectrum PRO, and Spectrum Plus devices are rechargeable. Return
Actiwatch Spectrum devices to Philips Respironics for battery replacement..
Actiwatch Spectrum PRO and Plus
Connect your device to your computer as shown on the previous page.The battery icon
( ) will animate on the display indicating that the device is charging.When the battery is
completely charged, the full battery icon ( ) will continuously blink.
Note: If the LCD display remains blank after connecting your device to the computer, your device
may have entered low power sleep mode due to a low battery condition. Press and release the
right button to wake up the device.
Actiwatch 2
Connect your communication dock to your computer, and then position the device on the
communication dock as shown on the previous page.
Note: For Actiwatch 2, Philips Respironics recommends fully charging before storage or use. Fully
charging may require 24 hours depending upon prior use.
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Cleaning
Make sure the Actiwatch device is clean before delivering it to the patient. It may be cleaned
with a soft cloth moistened in mild detergent and water to remove dirt and stains. Do not use
abrasives or alcohol as they may damage the device.
Maintenance
It is recommended that Actiwatch be returned to Philips Respironics after one year of field
use for preventative maintenance.The expected service life of Actiwatch is five years.
WEEE Recycling Directives
Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC.
Dispose of this device in accordance with local regulations.
Contacting Customer Service
For product support, call the Philips Respironics Customer Service department at
1-800-345-6443 (US and Canada only), 1-724-387-4000, or +49 815293060, or send an
You can also use the following addresses:
United States: Europe:
Respironics, Inc. Respironics Germany
1001 Murry Ridge Lane Gewerbestrasse 17
Murrysville, Pennsylvania 15668 USA 82211 Herrsching, Germany
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Specications
Temperature and Storage Information
Charging Operation Storage
Temperature: 5° C (41° F) to 30° C
(86° F)
5° C (41° F) to 40° C
(104° F)
-20 ° C (-4° F) to 60° C
(140° F)
Humidity: 15% to 95% RH
non-condensing
15% to 95% RH
non-condensing
15% to 95% RH
non-condensing
Actiwatch Spectrum PRO/Plus Power Input: 4.25 to 5.25 VDC, 100 mA
Standards Compliance
This device is designed to conform to the following standards:
IEC 60601-1: 2005 - Medical Electrical Equipment Part 1: General Requirements for Safety
IEC 60601-1-2: 2007 - Medical Electrical Equipment Part 1-2: General Requirements for Safety. Collateral
Standard: Electromechanical Compatibility - Requirements and Tests.
IEC 60601-1-11: 2010 - Medical electrical equipment Part 1-11: General Requirements for Safety.
Collateral standard: Requirements for Medical Electrical Equipment systems Used in the Home Healthcare
Environment (applies to Actiwatch Spectrum PRO & Plus devices only)
IEC 60601-1 Classication
Type of Protection Against Electric Shock: Internally Powered
Degree of Protection Against Electric Shock:Type BF Applied Part
Degree of Protection Against Ingress of Water: IP27
Mode of Operation: Continuous
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EMC Information
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
This Device is intended for use in the electromagnetic environment specified below.The user of the Device should assure that it is used in such
an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Radiated Emissions
CISPR 11 Group 1 Class B
This Device uses RF energy only for its internal function.Therefore,
its RF radiated emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF Conducted Emissions
CISPR 11
This Device is a battery operated device; therefore, these test requirements are not
applicable
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This Device is intended for use in the electromagnetic environment specified below.The user of the Device should assure that it is used in such
an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±6 kV Contact
±8 kV Air
±6 kV Contact
±8 kV Air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical Fast Transient/Burst
IEC 61000-4-4
This Device is a battery operated device and has no patient-coupled cables nor I/O cables
which are longer than 3 meters in length; therefore, this test requirement is not applicable.
Surge
IEC 61000-4-5 This Device is a battery operated device; therefore, these test requirements are not
applicable.
Voltage Dips, Short Interruptions and Voltage
Variations on Power Supply Input Lines
IEC 61000-4-11
Power Frequency (50/60 Hz) Magnetic Field
IEC 61000-4-8 3 A/m 3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical home or hospital environment.
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This Device is intended for use in the electromagnetic environment specified below.The user of the Device should assure that it is used in such
an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
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.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V
d=1.2√P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d=1.2√P80MHzto800MHz
d=2.3√P800MHzto2.5GHz
where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recom-
mended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electro-
magnetic site survey, ashould be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment marked with the
following symbol:
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 strength 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 abnor-
mal 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, field strengths should be less than 3V/m.
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Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Device.
The Device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.The user
of the Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communication equipment (transmitters) and the Device as recommended below, according to the maximum output
power of the communications equipment.
Rated Maximum
Output Power of
Transmitter (Watts)
Separation Distance According to Frequency of Transmitter (meters)
150 kHz to 80 MHz
d=1.2√P
80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 GHz
d=2.3√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 of
the transmitter manufacturer.
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.
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Warranty
Respironics warrants that the Actiwatch Spectrum PRO device, the Actiwatch Spectrum Plus device, the
Actiwatch 2 device and communication dock, and the Actiwatch Spectrum device and communication
dock (each a “Product”) will be free from defects in materials or workmanship for a period of one (1) year
from the date of delivery to the purchaser. During the warranty period, Respironics, at its option, will repair
or replace the defective Product, or issue a credit for the purchase price of the Product. Shipping costs to
Respironics are the responsibility of the purchaser.The foregoing repair, replacement or credit remedy will
be the sole remedy for breach of this warranty.
Without limiting the foregoing, this warranty does not cover damage to the Product caused by accident,
misuse, abuse, negligence, failure to operate under conditions of normal use and in accordance with the
terms of the user manual, failure to maintain in accordance with the applicable service manuals, alteration
or any defects not related to materials or workmanship.This warranty does not cover damage that may
occur in shipment.This warranty does not apply to any Product or individual parts that have been repaired
or altered by anyone other than Respironics or an authorized Respironics service center.This warranty does
not apply to any Product that is not purchased new.
RESPIRONICS DOES NOT MAKE AND HEREBY SPECIFICALLY DISCLAIMS,ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING,WITHOUT LIMITATION,ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
In no event shall Respironics be liable for lost prots, loss of good will, or incidental or consequential
damages, even if Respironics has been advised of the possibility of the same. No other person or entity
is authorized to make any warranties on behalf of Respironics, and Respironics disclaims any warranties
other than this warranty.
Laws vary from state to state and some states do not allow the exclusion or limitation of implied warranties
or the disclaimer of incidental and consequential damages. Accordingly, the laws of your state may give you
additional protections. In addition, if you are located outside of the United States, the laws of your country
may give you additional rights.
1104768
1104715 R01
JDH 04/24/2013
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