Watermark Medical ARES 610 User manual

www.watermarkmedical.com
ARES 610 PRODUCT GUIDE

CUSTOMER SUPPORT
MANUFACTURED FOR
If you have any questions regarding this product, please first refer to this guide. To
obtain warranty service, you must call Watermark Medical and speak with a Customer
Service Representative. Be prepared to provide: 1) your name, address and telephone
number, 2) the ARES model and serial numbers, and 3) an explanation of the problem.
Telephone: [phone]
Monday — Friday 8:00 AM to 5:00 PM Eastern Standard Time
Fax: [phone]
Web: www.watermarkmedical.com
Mailing: 1117 Perimeter Center West, Suite W514
Atlanta, GA 30338
Watermark Medical, Inc.
1117 Perimeter Center West, Suite W514
Atlanta, GA 30338

3
Contents
SAFETY INFORMATION AND INTRODUCTION ..............................1
A. About the Apnea Risk Evaluation System (ARES) .......................1
B. Safety..........................................................2
PREPARING THE ARES 610 FOR USE .....................................6
A. About Cleaning and Replacing Disposables ...........................6
B. Removing the Disposable Components with EEG ......................7
C. Cleaning the ARES & Forehead Sensor ...............................7
D. Replacing the Nasal Cannula ......................................10
E. Recharging the ARES Battery ..................................... 11
F. Replacing the Enclosure Strap and EEG Sensors ......................12
G. Placing the ARES in a Clean Resealing Bag ...........................12
ACQUIRING AND PROCESSING A SLEEP STUDY ..........................13
A. Initiating a Study ................................................13
B. Downloading Patient Data ........................................13
C. Reviewing Sleep Study Reports ....................................13
D. Dispensing the ARES to the Patient .................................14
ARES 610 SPECIFICATIONS ............................................15
General Compliance ................................................15
Audio Signals and Interpretation ......................................16
Table 204 .........................................................17
Table 201 .........................................................18
PATENT AND TRADEMARK ACKNOWLEDGEMENTS ........................18

1
SAFETY INFORMATION AND INTRODUCTION
A. About the Apnea Risk Evaluation System (ARES)
The Apnea Risk Evaluation System (ARESTM) provides an integrated approach to assist
in the diagnosis of obstructive sleep apnea (OSA). The ARES design combines existing
knowledge on sleep-disordered breathing with an easy-to-apply data acquisition
system. The ARES employs a multivariate approach combining physiological recordings
acquired during sleep with anthropomorphic and clinical information obtained from a
s t a n d a r d i z e d q u e s t i o n n a i r e . T h e A R E S in t e g r a te s : a ) a s e l f - a p p l i e d , s i n g l e s i te ( f o r e h e a d )
device to record continuous full-disclosure physiological signals during sleep in any en-
environment, b) a focused, validated questionnaire, c) automated software to recognize
and quantify abnormal respiratory events, and d) an expert system which utilizes this
information to identify levels of severity of OSA. By combining physiological data,
questionnaire responses, and expert pattern recognition software, the ARES is
designed to provide an accurate and valid assessment of sleep-disordered breathing
that is easily self-administered.
The ARES is a miniaturized recorder capable of recording oxygen saturation, pulse
rate, snoring level, head position/movement, and nasal pressure.
The ARES is easily placed on the forehead by the user and comfortably worn for 8-10
hours. The ARES provides sufficient battery capacity for two nights of recordings
(after seven continuous hours of recording the ARES conserves power by
automatically going into “sleep mode”). The battery must be recharged after
each use.
The ARES monitors signal quality during data acquisition, and notifies the user via a
voice prompt when adjustments are required. Several disposable components must be
replaced, and the forehead sensor cleaned before reuse.
The ARES Questionnaire is used to gather information about risk factors for sleep
apnea, including gender, body mass index, neck circumference, daytime drowsiness
(e.g., Epworth sleepiness score), frequency of snoring, observed apneas, and history of
hypertension or diabetes. The ARES applies patented algorithms to calculate SpO2 and
quantify the occurrence and severity of desaturation events and associated arousals
(based on changes in pulse rate, head movement, snoring sounds and/or airflow). The
ARES system software analyzes the ARES Questionnaire responses and assigns risk
levels of no, low, or high risk for OSA. A summary report provides information useful to
physicians in diagnosing obstructive sleep apnea.

2
B. Safety
The ARES should be prepared for patient use by a trained technician. Below are a
number of warnings and cautions. Read them carefully: they are important to the
effective and safe use of the product. The information in this guide has been carefully
reviewed and is based on our best judgment at this time. In the interest of continued
product development, Watermark Medical reserves the right to make changes and
improvements to this guide and the products it describes, at any time, without notice
or obligation.
CAUTION! Read this guide carefully before using the ARES.
Contraindications
1. Do not use the ARES in proximity to a Magnetic Resonance Imaging system.
2. Do not use the ARES as a substitute for clinical pulse oximetry.
The ARES is a recording device, not a monitoring device.
Warnings
1. Explosion Hazard. Do not use the ARES in the presence of or store near:
• Flammable anesthetics or gases
• High temperatures such as fire
• Enclosed areas in direct sunlight.
2. Warranty void if repairs/disassembly are performed by non-approved personnel.
Cautions - General
1. The ARES should be prepared for use by a trained technician.
2. U.S. Federal law restricts this device to sale by or on the order of a physician.
3. The ARES should only be worn by a patient after having read the written instructions
regarding product use provided by Watermark Medical.
4. Do not spray, pour, or spill any liquid on the ARES, its connectors, switches, or
openings. Such application of liquids may cause permanent damage and will void
the Warranty.
Warnings
CAUTION! Read this guide carefully before using the ARES.
Cautions - General

3
5. Do not use caustic or abrasive cleaning agents on the ARES, such use of cleaning
agents may cause permanent damage and will void the Warranty.
6. Do not introduce the device into an environment with pest issues (ex.: bedbugs).
Infestation of the device may cause permanent damage and will void the warranty.
NOTE: Replacement cost of devices returned due to bug infestation is the respon-
sibility of the customer.
7. Do not expose the device to patients with active infectious disease where the use
of barrier precautions is advised. The device cannot be used with any other patient
and must be returned to Watermark Medical for destruction. Replacement charges
are the responsibility of the customer.
8. This device has been tested and found to comply with the limits for medical
devices to the IEC 60601 standards. These safety standards are designed to
provide reasonable protection against harmful interference in a typical medical
installation.
9. Verify that the status indicator illuminates during the startup (initialization) sequence.
If any indicator is not lit, do not use the ARES. Contact Customer Support for repair
or replacement (877-710-6999).
10. For hygienic purposes, replace all disposable components, (i.e., the enclosure strap
and nasal cannula, etc.) after each patient use.
11. Always inspect and then disinfect the forehead sensor according to the recom-
mended guidelines. The forehead sensor is recommended for replacement after
approximately 60 nights of use. It should be replaced earlier if the inspection shows
that the surface that comes in contact with the forehead is cracked or pitted.
12. The ARES is a latex-free device and suitable for patients with latex allergy.
Cautions – Limitations of Use
1. The Apnea Risk Evaluation System (ARES) Model 610 is indicated for use in the diag-
nostic evaluation of adult patients with possible sleep apnea. The ARES can record
and score obstructive respiratory events during sleep (e.g., apneas, hypopneas,
mixed apneas, and flow-limited events). The device is designed for in-home screen-
ing of adults with possible sleep disorders.
2. The ARES is not recommended for unassisted use by patients with the following
conditions:
a. Deafness
b. Blindness
c. Severe arthritis which limits use of both hands
d. Dementia
Cautions – Limitations of Use

4
e. Supplemental oxygen use at night
f. Cardiac arrhythmia
g. Atrial fibrillation
h. Tics or tremors of the head
Unassisted use of the ARES by patients with any of these conditions may result in poor
signal quality that could lead to a misdiagnosis by the physician.
3. The ARES is not recommended for use by patients with the following conditions:
a. Sensitivity of skin or scalp and/or open wounds on the forehead or scalp
b. Allergic reactions to extended exposure to synthetic fabrics (e.g., polyester,
rayon)
c. Upper respiratory infection or congestion
d. Active, contagious, infectious disease (ex.: MRSA, C. diff) where barrier
precautions are advised.
NOTE: If a device is used with a person with active, infectious disease the
customer must alert Watermark Medical and arrange for the return of the
device through Customer Support. The device cannot be used on any other
patient and must be returned for destruction. The customer is responsible for
replacement charges.
e. Inability to sleep at least 5-hours per night or a total of 8-hours over two nights.
f. Inability to sleep with head reclined (less than 60 degree angle)
g. Head circumference less than 20 inches or greater than 25 inches
Use of the ARES by patients with any of these conditions may result in poor signal quality
that could lead to a misdiagnosis by the physician.
4. The proper use of the ARES requires patients to be dexterous in both hands, capa-
ble of reading and comprehending instructions, and able to see and hear the audio
and visual indicators. If the patient cannot meet these requirements the result may
be poor signal quality leading to a misdiagnosis by the physician. Such patients
require assistance to ensure that the ARES records accurate data.
5. ARES use under any of the following conditions may result in poor signal quality that
could lead to a misdiagnosis by the physician:
a. Strap not adjusted properly; too loose or too tight.
b. Forehead not prepared according to instructions (e.g., makeup, lotion or hair
under the sensor).
c. Loud snoring bed partner or significant ambient noise.
6. The ARES device is not to be used on children.

5
7. In less than 0.1% of cases, patients may experience a red mark appearing on the
forehead after the study. The mark is similar to a sore that sometimes occurs when
a patient wears a CPAP mask. This mark is normal and usually disappears in a few
hours. On rare occasions, it may remain for two or three days.
If the patient experiences ANY adverse reaction, they should discontinue use and consult
their health care professional.
Cautions - Battery
1. Device should be fully charged prior to first use. The green indicator light on the
ARES will switch off when fully charged.
2. Recharge the ARES batteries only using the wall charger provided.
3. Do not attempt to charge the ARES with a charger from another product.
4. Do not rely on the USB port on a computer for proper charging.
5. For optimal performance, use fully recharged batteries.
6. The wall charger should not be sent home with the patient.
7. Follow local ordinances and recycling instructions regarding disposal or recycling
of the device and device components, including the battery. The battery might leak
or explode if it is used or disposed of improperly.
Guide to Symbols:
Warnings are identified by the WARNING symbol shown to the left.
Cautions are identified by the CAUTION symbol shown to the left.
Attention – See “Instructions for Use” identified by the ATTENTION
symbol shown to the left.
Cautions - Battery

6
PREPARING THE ARES 610 FOR USE
A. About Cleaning and Replacing Disposables
The forehead sensor, enclosure pad, and ARES enclosure must be cleaned and the
enclosure strap, nasal cannula and EEG disposables must be replaced after each
patient use. After the disposables have been replaced the ARES must be placed in a
clean resealing bag. The following tasks should be performed after data has been suc-
cessfully downloaded from the ARES:
1. Unscrew the Nasal Cannula luer lock from the Enclosure luer lock.
2. Remove the EEG sensors, enclosure strap, and nasal cannula.
3. Initialize the ARES.
4. Recharge the batteries.
5. Apply non-latex gloves and clean the sensor.
6. Clean the enclosure.
7. Replace the strap.
8. Apply new EEG sensors.
9. Apply new nasal cannula.
10. Place the ARES in customized packaging.
11. Upload patient information.
COMPONENT DESCRIPTION
1. Enclosure Strap
2. Stabilizing Strap Snap
3. Cannula Tip
4. Cannula Clip
5. Stabilizing Straps
6. Enclosure Luer Lock
7. Nasal Cannula Luer Lock
8. Slip Tube
9. Forehead Sensor
10. On/Off Button
11. USB Cable Connector
12. EEG Flex Cable
13. EEG Sensor

7
B. Removing the Disposable Components with EEG
Remove the EEG sensors by grasping the Enclosure strap and the EEG flex cable with
one hand and pulling on the EEG sensor with the other.
1. Unsnap the Enclosure strap from the Stabilizing Straps.
2. Unscrew the Nasal Cannula from the Cannula Luer Lock on the Enclosure.
3. The disposable components are single use and must be discarded.
C. Cleaning the ARES & Forehead Sensor
Materials:
1. Alcohol-based hand sanitizer meeting CDC hand hygiene guidelines.
2. Two 70% Isopropyl Alcohol Pads
3. Non-latex or nitrile gloves
Parts Reference:
COMPONENT DESCRIPTION
1. Luer Lock
2. Forehead Sensor
3. Forehead Sensor Windows
4. Sensor Enclosure Pad

8
Procedure:
1. Remove the clear plastic sheet covering
the forehead sensor.
2. Apply a small amount of alcohol-based
hand sanitizer meeting CDC hand hygiene
guidelines to your index finger.
3. Push down the long edge of the forehead sensor closest to
the plastic Luer lock and gently lift up the other long side of
the forehead sensor. Thoroughly rub all exposed areas of the
sensor enclosure pad underneath the forehead sensor
and the underside of the forehead sensor for approximately
10 seconds. (Please see cautions on page 10 for information
on lifting the forehead sensor).
4. Push down the long edge of the forehead sensor closest to
the grid of speaker holes and gently lift up the other long side
of the forehead sensor. Thoroughly rub all exposed areas of
the sensor enclosure pad underneath the forehead sensor
and the underside of the forehead sensor for approximately
10 seconds. (Please see cautions on page 10 for information
on lifting the forehead sensor).
5. Thoroughly rub the top and side surfaces of the forehead sensor and the rim of
sensor enclosure pad surrounding the forehead sensor with your index finger
containing the gel for approximately 10 seconds. (Please see cautions on
page 10 for information on rubbing the sensor and sensor enclosure pad).
2
3
4
1
5

9
6. Perform Steps 1—5 again using a 70% alcohol pad instead of hand sanitizer. (See
photos below.
7. Let the unit air-dry; the alcohol drops will dry in approximately 30-60 seconds.
8. Look underneath the forehead sensor and ensure the cable is feeding directly
though the hole in the sensor enclosure pad. Gently press the forehead sensor into
the sensor enclosure pad cavity and apply a clean, clear plastic cover and place the
Unicorder in a clean plastic bag.
CAUTION:
• Vigorous rubbing of the sensor with sufficient moisture from cleansing gel and
isopropyl alcohol is required for proper cleaning.
• Do not tug on the forehead sensor when lifting it to clean sides of sensor and
sensor enclosure pad underneath forehead sensor.
• To avoid damaging the sensor, do not rub it with your finger when the sensor
is dry.
• Pulling upward too hard on the forehead sensor during cleaning can cause
permanent damage to the forehead sensor and/or Unicorder connector.

10
• The forehead sensor is recommended to be replaced after approximately
60 nights of use or when the sensor surface becomes pitted or cracked. The
forehead sensor is not covered by the warranty. Use care when cleaning to
maximize life of this sensor.
D. Replacing the Nasal Cannula
1. Place the ARES on a flat surface with the luer lock connector pointing upward.
2. Place the two cannula tips in front of the ARES with the tips curving toward the
device.
3. Begin affixing the cannula tubing into the four cannula clips on the strap. Pull down
slightly on the tubing on both sides of the clip until the tubing slides into the clip.
4. Attach the Nasal Cannula luer lock to the enclosure luer lock and rotate it clockwise
until it stops.
5. Check to be sure the Nasal Cannula luer lock is firmly connected to the enclosure
luer lock.

11
E. Recharging the ARES Battery
CAUTION: The ARES should only be recharged by trained staff.
CAUTION: Do Not Touch the metal snaps on the flex circuit during charging.
1. The batteries will need to be recharged within two weeks to complete a two-night
study, and every four weeks to complete a one-night study.
2. To recharge the ARES, plug the wall charger
into a power outlet and confirm the light on the
charger is illuminated.
3. Insert a USB cable into the wall charger and
into the ARES.
4. The ARES will switch on after the USB cable
is inserted. A voice message will indicate the
battery is charging and the green indicator light
on the ARES will blink once per second. The
green light on the front of the ARES will flash
rapidly during charging and will stop flashing
when charging is complete.
5. If there is a problem with the charging, the ARES
will provide a voice message or chirp 4 times a second.
6. The green indicator light on the ARES will switch off when charging is finished.
Remove the USB Cable from the ARES and it will shut off automatically.
7. Recharge the ARES with the USB charger supplied. Do not charge the ARES by
connecting it to the USB port on a computer.
Note: If the voice message does not sound and the ARES light is not flashing then the battery is
completely drained and the device must be trickle charged for 5 minutes. After 5 minutes, remove
the ARES from the cable and plug it back in, this time the voice message “the ARES is Charging”
will sound and normal charging will continue. Call Technical Support at [phone] if you have
additional questions.
CAUTION: The ARES should only be recharged by trained staff.
CAUTION: Do Not Touch the metal snaps on the flex circuit during charging.
2
3

12
F. Replacing the Enclosure Strap and EEG Sensors
CAUTION: If the Stabilizing Straps become damaged the result can be poor
signal quality with compromised test.
1. Each side of the Enclosure Strap is labeled with the letter L or the letter R. Each
Stabilizing Strap is also labeled with letters L and R.
2. Snap the L side of the Enclosure Strap to the L
Stabilizing Strap.
3. Snap the R side of the Enclosure Strap to the R
Stabilizing Strap.
4. Snap the EEG Sensor into the connector on the
EEG Flex circuit. Repeat for the other EEG Sensor
and Flex circuit.
G. Placing the ARES in a Clean Resealing Bag
After the ARES has been cleaned, the plastic sensor cover has been applied and new
disposable components have been applied, the ARES must be placed in a new reseal-
ing bag so as not to contaminate any of the ARES surfaces and to protect the silicone
forehead sensor during transportation.
CAUTION: If the Stabilizing Straps become damaged the result can be poor
Number Description of Component Number Description of Component
1 EEG Sensor Snap 3 EEG Flex Circuit
2EEG Sensor 4 EEG Flex Circuit Connector

13
ACQUIRING AND PROCESSING A SLEEP STUDY
The ARES device is operated through the Watermark Medical Website. The ARES
Portal is used to perform basic operations for completing a home sleep test, including
initializing the device for user, downloading and processing the study, and retrieving
study results. To login to the ARES Portal the user should navigate to the Watermark
website at www.watermarkmedical.com. User login information should be obtained
through your Sales Representative or customer service.
The ARES portal requires some custom files to be installed on each computer that will
initialize and process study information on the device. This software will automatically
be installed the first time the computer uses the website. Administrative rights on the
machine are required to do the install but after the install all users should be able to
process studies on the machine.
The ARES portal must be run in Microsoft’s Internet Explorer or Google Chrome and
requires the Microsoft .Net 3.5 framework or higher to be installed on the system.
A. Initiating a Study
1. The initialize device process checks the status of the device and writes some basic
patient identifiers on to the device before dispensing the device to the patient.
2. The device must be attached to the machine using the provided USB cable. From
the ARES portal main menu the user will click on the new study menu item. The user
completes the patient information and clicks the initialize device button.
B. Downloading Patient Data
1. From the ARES portal main menu the user will click on the process study item. The
device will be recognized and the initialization data will be pre-populated for the user.
The user will complete additional study information and then click on the upload
button.
2. The sleep study data will be retrieved from the device (this process takes several
minutes) and then uploaded to the Watermark Secure Servers. After successfully
uploading the data, the device will be formatted and ready for charging.
C. Reviewing Sleep Study Reports
1. Completed sleep studies will be posted to the ARES portal and can be retrieved in
a PDF format by clicking on the reports menu of the portal.

14
D. Dispensing the ARES to the Patient
1. Review the ARES Dispensing instructions with the patient.
2. Measure the head circumference of the patient
and adjust the strap according to the table. (See
the ARES Dispensing Instructions document for
measurement instructions.)
3. Show patient how to apply the ARES at home:
a. Thoroughly wash and dry your forehead.
b. Remove the plastic covers from the electrodes and the forehead sensor.
c. Center the ARES sensor to the forehead and gently pull the black strap into
place.
d. Remove hair from under the sensor.
e. Adjust the slip tube to tighten the cannula. Make sure the cannula tips cannot
be pulled more than 1⁄4 inch away from the nose.
f. When removing the ARES, gently peel the black sensor away from your
forehead prior to completely removing the ARES from your head. Failure to do
so may damage the sensor connector.
Problem to avoid: If the slip tube is not tight enough the airflow alert will sound during
the night. A 1⁄4 inch error in slip tube adjustment may cause poor signal quality.
Alerts: Communicate with the patient about the ARES device alerts. The different
alerts displayed by the device are described in the user guide provided to the patient.

15
ARES 610 SPECIFICATIONS
General Compliance
Item Compliant With
Environmental
Conditions Operation Transportation Storage
Temperature 5°C to 40°C
41°F to 104°F
-20°C to 70°C
-4°F to 140°F
-20°C to 70°C
-4°F to 140°F
Altitude -390m to 3,012m
-254 ft. to 9.882 ft.
-390m to 3,012m
-254 ft. to 9.882 ft.
-390m to 3,012m
-254 ft. to 9.882 ft.
Atmospheric
Pressure
70 kPa to 106 kPa
20.6 in. Hg to 31.3 in. Hg
70 kPa to 106 kPa
20.6 in. Hg to 31.3 in. Hg
70 kPa to 106 kPa
20.6 in. Hg to 31.3 in. Hg
Relative
Humidity
15% to 95%
non-condensing to be
compliant with
IEC 60601-1,
sub-clause 44.5
15% to 95%
non-condensing
15% to 95%
non-condensing
Equipment classification Safety Standards: IEC 60601-1, CSA 601.1
UL 2601-1, EN/IEC 60601-1-2 2nd edition
Type of protection Class II, internally powered by battery
Degree of protection against
electrical shock Type BF – Applied part
Mode of operation Continuous
Degree of Safety in presence of
flammable mixtures UL 2601-1, sub-clause 5.5, Not suitable
Applied sensor label to indicate
Type BF applied part IEC 60601-1 Symbol 2 of Table DII of Appendix D
Attention Symbol, consult
accompanying documentation IEC 60601-1 Symbol 9 of Table DII of Appendix D
External case made with
non-conductive plastic IEC 60601-1, sub-clause 16(b)
Case mechanically strong IEC 60601-1
Electromagnetic compatibility IEC 60601-1, sub-class 36 IEC/EN 60601-1-2 2nd edition
Electrostatic discharge immunity IEC 60601-1-1-2, EN 61000-4-2
Radiated magnetic field emissions IEC 60601-1-1-2, EN 61000-4-3
Magnetic field susceptibility IEC 60601-1-1-2, EN 61000-4-8

16
Audio Signals and Interpretation
Event Sound When Audio

17
Table 204
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
• 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 Model 610 is used
exceeds the applicable RF compliance level above, the Model 610 should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Model 610.
• Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3V/m.