Page 1
Directions
for Use
Model sam-271
Page 2
sam
Product Support 1-888-202-9831
Page 3
Contents
1. Introduction .............................................................................................................................................. 4
2. Indications for Use ................................................................................................................................ 4
3. Safety .......................................................................................................................................................... 5
3.1. Contraindications ................................................................................................................................... 5
3.2. Warnings .................................................................................................................................................... 5
3.3. Precautions ............................................................................................................................................... 6
4. Features of the sam Device ............................................................................................................. 8
5. sam Components ............................................................................................................................... 9
6. Operator Interface ............................................................................................................................... 10
7. Accessories ............................................................................................................................................ 10
8. LED Display .............................................................................................................................................. 11
9. Initial Setup Instructions ................................................................................................................... 13
10. Treatment Options ............................................................................................................................... 13
11. Application Instructions .................................................................................................................... 16
12. Device Power Down and Removal ............................................................................................... 22
13. Modes of Operation ........................................................................................................................... 23
14. Cleaning and Maintenance ............................................................................................................. 24
15. Storage and Operating Conditions ............................................................................................. 24
16. Disposal of Waste Products ........................................................................................................... 25
17. Appendix ................................................................................................................................................. 26
A. Symbols ........................................................................................................................................ 26
B. Specifications ............................................................................................................................. 27
C. Notice of Compliance, Calibration and Operational Period .................................. 28
D. Technical Information ............................................................................................................. 29
E. Electrical Immunity and Emissions ................................................................................... 30
F. Warranty ........................................................................................................................................ 33
G. Troubleshooting ....................................................................................................................... 34
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1. Introduction
Thank you for choosing sam! This manual contains general instructions for operation,
application, precautions, and maintenance. In order to obtain maximum life and
efficiency from the sam Device and to assist in the proper operation of the device,
please read and understand this manual thoroughly. This device is only to be used as
directed in this manual.
sam was developed as a next generation wearable ultrasound therapy system which
combines miniaturization technology into a small and portable ultrasound therapy
system. It is designed to work with the human body and maximize the safe and effective
delivery of long-duration therapeutic ultrasound. Simple to administer and operate on
a broad range of body types, sam allows the delivery of ultrasound treatment for up to
four hours. It operates at a preset frequency and allows the use of up to two applicators
simultaneously. Applicators are applied and secured to the surface of the body using
convenient sam Ultrasound Coupling Patches.
The specifications put forth in this manual were in effect at the time of publication.
1.1. GENERAL SAFETY
Thoroughly read and understand the precautionary and operating instructions before
attempting to operate the sam Ultrasonic Diathermy Device. Know the limitations and
hazards associated with using any ultrasound device. Observe the precautionary and
operational information on the device. Periodically review the operation procedures and
safety precautions outlined in this manual.
1.2. USA: PRESCRIPTION USE ONLY
Caution: Federal law restricts this device to sale by or on the order of a practitioner
licensed by the law of the state in which he/she practices to use or order the
use of the device.
This device complies with 21 C.F.R. § 1050.10
2. Indications for Use
The sam Ultrasonic Diathermy Device is intended to apply ultrasonic energy to
generate deep heat within body tissues for the treatment of selected medical
conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint
contractures and the local increase of circulation.
The sam Ultrasonic Diathermy Device is a prescription use device. sam should only be
administered and monitored by a licensed healthcare practitioner.
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3. Safety
3.1. CONTRAINDICATIONS
Contraindications for the use of ultrasound include:
• Over an area of the body where a malignancy is known to be present
• Over the eyes
• Over or near growth centers until bone growth is complete
• Over the reproductive organs
• Over the pregnant uterus
• Over a healing bone fracture
• On the thoracic area if the patient is using a cardiac pacemaker
• Over an active implanted medical device such as an implanted deep brain
stimulation device
• On the brain, spinal cord, or large subcutaneous peripheral nerves
• Ischemic tissues in individuals with vascular disease where the blood supply
would be unable to follow the increase in metabolic demand and tissue necrosis
might result
3.2. WARNINGS
• If the treatment is reported as painful or too hot at any point during treatment,
turn off device and remove the device from the skin.
• Instruct the patient to inform the practitioner if the patient feels any pain or
burning during treatment.
• Instruct the patient how to turn off the sam Device and remove the sam
Applicator if the patient feels any pain or burning during treatment.
• ALWAYS administer treatment using a new sam Ultrasound Coupling Patch. Use
one sam Ultrasound Coupling Patch per applicator. Use of the sam Ultrasound
Applicator without a new sam Ultrasound Coupling Patch MAY RESULT IN BURN
and/or REPEATED SHUTOFF of the sam Applicator.
• The sam Device should be kept out of the reach of children.
• DO NOT apply the sam Applicator with alternative coupling media as a
replacement for the sam Ultrasound Coupling Patch. Use of alternative
coupling media in lieu of the sam Ultrasound Coupling Patches may reduce the
effectiveness of treatment, lead to automatic shutoff of the applicator, or cause a
burn.
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• DO NOT administer treatment if the applicator is not connected to a sam
Ultrasound Coupling Patch.
• Applicators and sam Ultrasound Coupling Patches are not sterile. DO NOT apply
this device over an open wound or inflamed skin.
• DO NOT use the sam Ultrasound Coupling Patch if the sam Ultrasound Media
is dried out. Indications of a dried out Patch include: the cup is not full of gel,
there is dry residue or film in the cup, or there is any cut, break, or opening in
the Patch or seals.
• DO NOT apply directly over a bone that is near the skin surface.
3.3. PRECAUTIONS
Precaution should be taken when using the device:
• Over an area of the spinal cord following a laminectomy, i.e. when major covering
tissues have been removed
• On patients with hemorrhagic diatheses
• Over areas where metal prosthesis or other metallic implants are embedded
in tissue which may form a reflective surface to the ultrasound energy causing
unintended irradiation of tissue and excessive heating
• Over an acute infection or sepsis
• On patients with peripheral artery disease
• Over a deep vein thrombosis
• Over an anesthetized area or in conjunction with a condition that causes
impairment of sensation, such as caused by chemotherapy
• When using the sam Ultrasound Coupling Patch, ensure the top and bottom
seals have been completely removed before attaching the applicator to the skin
3.4. INFLAMMABLE GASES AND ANESTHETICS
• Warning: Explosion hazard if used in the presence of flammable anesthetics,
open flame, or oxygen-rich environment
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3.5. ELECTRONICS AND BATTERY
WARNINGS
• This device is rated IPX0; therefore, it is Not Waterproof. DO NOT apply a direct
stream of any liquid onto the device, submerge the device, or allow any liquid to
pool on the surface of the device. DO NOT use if device has been submerged
in water.
• This device contains a rechargeable lithium-ion battery. DO NOT disassemble,
DO NOT heat above 100°C, DO NOT incinerate or expose to water and
DO NOT ingest.
• The use of accessories, transducers and/or cables other than those specified,
with the exception of those sold by the manufacturer as replacement parts for
internal components, may result in increased emissions or decreased electrical
immunity of the equipment or system.
• DO NOT open or modify any component of the sam Device. Hazards such
as shock, burn or inappropriate functionality can result from unauthorized
modification of the sam Device.
• Use of the sam Device around electromagnetic interference may negatively
affect the output performance and safety of the device. Do not use the device if
any abnormal functionality occurs.
PRECAUTIONS
• Only recharge the sam Device using the sam Electrical Charger. Use with any
other recharging device may result in damage to the system and void
all warranties.
• When not in use, power ‘OFF’ the device to protect the functionality of
the components.
• Avoid dropping the applicator or power controller and avoid scratching the
lens of the applicator. Rough handling may reduce the device’s acoustic output
power, thereby reducing the effectiveness of therapy.
• The power controller and applicators should be routinely checked for cracks and
other damage before each use to determine that the device functions normally.
• DO NOT place the device in a location where the power charging cord could be
a trip hazard.
• DO NOT use sharp objects such as a pencil point or ball point pen to operate the
buttons on the control panel as damage may result.
• Prevent potential electromagnetic or other interference. DO NOT open the sam
Device or connect the device or components of the device to any non-sam
part. Keep the device clean and make sure no exposed non-insulated wires are
visible. If damage is present, do not administer treatment.
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4. Features of the sam Device
4.1. PRESET TREATMENT
The sam Device is preconfigured to provide continuous ultrasonic output at a preset
frequency and intensity which cannot be modified by the user. The user can set the
treatment duration to be 1, 2, 3, or 4 hours.
4.2. sam ULTRASOUND APPLICATORS
The sam Ultrasound Applicators serve as the ultrasound transducers of the
sam Device. The applicators offer low-profile design with light emitting diode (LED) on/
off notification. The ergonomic plastic housing and smooth contours provide
enhanced comfort.
4.3. sam SENSING
sam is designed to work with the human body and maximize the safe and effective
delivery of long-duration therapeutic ultrasound. Each sam Applicator is equipped
with closed-loop continuous temperature monitoring which maintains treatment site
temperatures below 44°C during normal operation. See section 13.4 on page 24 for
more information.
4.4. sam ULTRASOUND COUPLING Patches
The sam Device utilizes ultrasound coupling Patches which are manufactured with
ultrasound coupling media sealed inside. The ultrasound coupling Patches ARE
REQUIRED to secure the sam Applicators to the body.
4.5. BATTERY OPERATION
Powered by a rechargeable lithium-ion battery, the sam Device can provide
4 hours of therapy on a single battery charge.
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UB-12
AT- 1 2
5. sam Components
PC271 UB14
4 HRS
K
C
E
H
C
Y
R
E
T
T
A
B
3
2
1
DONE
CT271
YB271
YB-12
if included
AT271
AT-1 2
figure 1: sam Model 271 Components
sam MODEL 271 COMPONENTS
AT271: Ultrasound Applicators
UB14: Ultrasound Coupling Patches
OM271: User Manual
PC271: Power Controller
CT271: Electrical Charger
YB271: Y-branch Adapter
AT271
AT-1 2
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6. Operator Interface
Battery
Indicator LED
Power Button
K
C
E
H
C
Y
R
E
T
T
A
B
Treatment
Timer LED
Front
Charge Port
Indicator LED
4 HRS
3
2
1
DONE
figure 2: sam Interface Components
Side
Bottom
Toggle
Button
Indicator LED
Applicator
Connection
7. Accessories
The sam Device may be used with any of the following accessories:
sam Belt Clip
sam Armband
sam Carrying Case
* Additional sam Ultrasound Coupling Patches may be obtained by contacting
the manufacturer
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8. LED Display
The sam Device contains Light Emitting Diode (LED) displays that indicate the
functions of the device (see Figure 2).
8.1. POWER CONTROLLER INDICATOR LED
The Indicator LED provides power, charging and error checking information.
Color of Indicator LED Meaning
Opaque (absence of light) Power Controller is OFF.
No power is being generated
Blue Power Controller is ON. Note – Ultrasonic
energy is generated only when the Power
Controller is connected to the sam
Applicator(s)
Green Power Controller battery is fully charged
Amber Power Controller battery is charging
Red Too many applicators are attached. A
maximum of two applicators may be
attached to a single power controller at
any time
Table 1. Power Controller LED Color Definitions
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8.2. CONTROL PANEL
The front face of the sam Power Controller contains a control panel. The LEDs on the
control panel are divided into a field for Battery Indicator and a field for Treatment Timer.
The operator is able to make selections by pressing the Power Button and the Toggle
Button.
Color of Battery Indicator LED* Meaning
Red Only Low Battery, Re-Charge required
Blinking Red Re-Charge required
Amber Power Controller is partially charged
Green Power Controller fully charged
*These lights remain on for 4 seconds and subsequently turn off
Table 2. Battery Indicator LED Color Definitions
Treatment Time Indicator LED Meaning
Blue Treatment time remaining. Treatment
timer is set in one hour increments.
Amber Treatment complete. This single “done”
light will activate only when a treatment
cycle has completed and will remain
illuminated for 8 hours, then turn off
Table 3. Treatment Time Indicator LED Color Definitions
8.3. APPLICATOR INDICATOR LED
LED Color Meaning
Opaque (absence of light) Applicator is not receiving power
Blue Applicator is receiving power from the
Power Controller. Ultrasonic energy is
being generated at all times this light
is illuminated
Red (accompanied by vibration) sam Sensing Mode. No Ultrasonic energy
is being generated from this applicator
while this light is illuminated
Table 4. Applicator LED Color Definitions
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Bottom of sam Power Controller
Micro USB
Bottom of sam Power Controller
Micro USB
Wall Charger
Outlet
9. Initial Setup Instructions
Remove the sam Device components (Figure
1) from the packaging and inspect for any damage
that may have occurred during shipment. Charge
the device for up to 6 hours or until the Power
Controller Indicator LED is Green. The sam Device
arrives only partially charged due to generally
accepted shipping practices.
9.1. CHARGING THE POWER
CONTROLLER
A. Peel back the dust cover on the bottom
of the sam Power Controller and plug
the micro USB end of the sam Electrical
Charger into the charging port.
B. Plug the electrical charger into a 120230
VAC wall outlet. The sam Power Controller
indicator LED will be amber. When the
device is fully charged the top right indicator
LED will change from amber
to green.
figure 3A
10. Treatment Options
10.1. TREATMENT DURATION
The sam Ultrasonic Diathermy Device provides
ultrasound therapy at a preset frequency and
intensity. The user can program the treatment
duration to be 1, 2, 3, or 4 hours. The maximum
treatment duration setting on the sam Device
is 4 hours. Treatment duration should be set to
the minimum increment required for effective
therapy. Due to individual differences in skin type
and tolerance, it is recommended to begin with a
1 hour treatment. Increase treatment duration in
subsequent applications only as tolerated. Maximum
usage time is 4 hours per day per treatment area.
The sam Device may be used while charging.
Charging the device during treatment has no impact
on device frequency or intensity output settings. If
using sam while charging, position the device in
such a way that the charger cable is easily removed
from the power Controller if needed.
figure 3B
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10.2. TREATMENT LOCATIONS
Knee
Shoulder
Figures 4 and 5 depict examples of device
placement on two treatment locations. Figure
4A and 4B illustrates using the sam Device with
one applicator on the shoulder and knee. Figure
5A and 5B illustrates using the sam Device with
two applicators on the shoulder and knee. When
determining treatment location, consider that
the maximum diathermic effect will occur directly
under the applicator face; therefore, placing
the applicator near or directly over the target
area while following all warning and cautionary
instructions is advised.
Note: These figures are examples and are not
intended to be the suggested or only
allowable applicator configurations for those
body locations.
Warning: Do Not apply directly over a bone that is
near the skin surface.
figure 4A: Single Shoulder Application
10.3. ONE OR TWO APPLICATORS
The sam Device may be used with one or two
applicators simultaneously. The decision to use
one or two applicators is dependent on the
size and anatomical area of treatment. Using
two applicators allows a larger area of tissue to
receive ultrasound treatment. For example, large
anatomical regions, such as the shoulder could
benefit from two applicators, whereas smaller
treatment areas such as the forearm may only
require one.
10.3.1. SINGLEAPPLICATOR MODE
Connect the power controller wire to a single
applicator by inserting the power controller wire
jack into the matching cavity at the base of the
applicator. The port for the power controller wire is
described as ‘Applicator connection’ on the Power
Controller drawing shown in Figure 2, page 10.
figure 4B: Single knee Application
figure 5A: Dual Shoulder Application
figure 5B: Dual Knee Application
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10.3.2. DUALAPPLICATOR MODE
The Y-adapter (optional) may be used to power two Applicators simultaneously. As
shown in Figure 8, connect the Y-adapter directly to the Power Controller wire and then
connect each Applicator to a wire jack at the other end of the Y-adapter.
When using two sam Applicators and two sam Ultrasound Coupling Patches
simultaneously, the sam Ultrasound Coupling Patches should be positioned so that
their footprints do not overlap.
Caution: DO NOT overlap sam Ultrasound Coupling Patches (Figure 6).
Caution: DO NOT use the Y-adapter when using only one applicator for treatment.
Caution: Do NOT attach more than one Y-adapter to the sam Device.
Note: If two applicators will be used, two sam Ultrasound Coupling Patches (one for
each applicator) and the Y-adapter must be used for the treatment.
figure 6: NO Patch Overlap
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11. Application Instructions
11.1. CHECK DEVICE CHARGE
A. Check to make sure the Power Controller
holds enough charge to provide the
desired duration of treatment. Press
the Toggle Button on the sam Power
Controller to view the battery indicator
lights (Figure 7). The lights will illuminate to
show how much battery life is remaining
in the device. If the device is not fully
charged it may not be able to deliver
treatment for 4 hours. The device will only
permit the user to set a treatment duration
for which the battery charge is capable
of fulfilling.
i. To check the treatment duration for
which the battery charge is capable of
fulfilling, simply continue to press the
Toggle Button sequentially to view all
timer settings allowed by the current
battery charge. See section 9 for
charging instructions.
figure 7: Check Device Charger
Toggle
Button
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11.2. CONNECT APPLICATOR TO POWER CONTROLLER
4
HRS
3
2
1
DONE
B
A
T
T
E
R
Y
C
H
E
C
K
45
Rotate Clockwise
45
* If using 2 applicators: first connect the Y-adapter directly to the power controller
wire jack and then connect each applicator to a wire jack at the other end of the
Y-adapter (Figure 8*).
A. Insert the power controller wire into the matching cavity at the base of the
applicator at a 45 degree angle (Figure 8A).
B. Gently twist the wire jack clockwise until the applicator edge is flush with the
wire jack (Figure 8B).
figure 8*: Connecting Y-Adapter
figure 8B: Gently twist to Lock
figure 8A: Insert power controller wire at 450 angle
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11.3. ATTACH APPLICATOR TO PATCH
A. Remove the circular seal from the top of
the Patch to reveal the coupling media
within the gel cup (Figure 9A).
B. While supporting the edges of the cup
with your fingers, align the applicator, face
down, above the cup and coupling media
(Figure 9B).
C. While continuing to support the edges
of the cup, firmly press the applicator
down onto the center of the gel cup
until a clicking noise is heard or clicking
sensation is felt
(Figure 9C).
If using dual applicators, repeat these steps with
the second applicator and the second Patch.
Note: When the applicator is pressed down onto
the gel cup, keep your fingers on the back of
the patch, keeping them on the edges of the
cup and NOT at the center of the Gel pack.
Note: Do not be concerned if coupling media
flows out the edges of the gel cup. Wipe any
excess coupling media away with a tissue or
towel
figure 9A: Removing Foil Seal
figure 9B: Attach Applicator
Note: Ensure the applicator is fully attached to the
Patch.
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figure 9C: Press Applicator Down
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11.4. APPLY ULTRASOUND
Knee
COUPLING PATCH TO TREATMENT
LOCATION
A. Hold the applicator so the bottom of the
Patch faces up. Remove the circular foil
seal, revealing the gel.
B. Remove the paper liner, revealing the
Patch adhesive (Figure 10A).
i. Add more sam Coupling Media
as needed.
C. Turn the Patch over and adhere the Patch
to the desired treatment location (Figure
10B).
i. The sam Coupling Media must be in
direct contact with the skin.
If using dual applicators, repeat these steps to
adhere the second Patch and applicator to the
second treatment site.
Note: When applying Patches, both sides of
the ultrasound coupling media should be
uncovered. One side should be in contact
with the skin. The other side should be in
contact with the face of the applicator.
figure 10A: Removing Paper Liner
figure 10B: Adhere Patch to Site
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11.5. TURN THE DEVICE ‘ON’
4
HRS
3
2
1
DONE
Power Button
A. Press and hold the Power Button on the
sam Power Controller for at least 1 second
to turn the device ‘ON’ (Figure 11A).
i. As confirmation that the device is ‘ON’,
the LEDs on the sam Power Controller
will illuminate blue (treatment timer and
indicator LEDs) and the indicator LED
on the applicator will illuminate blue.
ii. The battery indicator LEDs will remain
‘ON’ for about 4 seconds after turning
‘ON’ the device.
iii. The treatment timer LEDs and blue
indicator LEDs (power controller and
applicator) will remain ‘ON’ for the
duration of treatment.
B. Press the Toggle Button to select 1, 2, 3 or
4 hour treatment duration (as allowed by
current battery charge) (Figure 11B).
i. If the Toggle Button is pressed up to
the 4 hour setting and a decreased
treatment time is desired, pressing it
again will return the treatment timer to
the 1 hour setting.
figure 11B: Press Power Button
Toggle
Button
figure 11B: Select Duration
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11.6. TREATMENT DELIVERY
Treatment will be delivered for the duration set by
the user. The treatment timer LEDs will count down
in hour increments as treatment progresses. Upon
completion, the device will automatically shut off
and the ‘treatment complete’ LED will illuminate
for approximately 8 hours before turning off. See
section 12 for how to manually power ‘OFF’
the device.
Warning: ALWAYS instruct the patient to alert the practitioner in the event of discomfort
during treatment.
Warning: As an additional safety measure, ALWAYS instruct the patient how to turn off
the sam Device and remove the sam Applicator in the event of discomfort
or emergency.
Warning: ALWAYS keep the sam Power Controller within easy reach so that power may
be ceased at any time.
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12. Device Power Down and Removal
MODEL
AT-12
Pull Tab
12.1. POWER OFF THE POWER CONTROLLER
Press and hold the Power Button on the sam Power Controller for at least 1 second to
turn the device ‘OFF’ (See Figure 11A for device diagram).
12.2. REMOVE DEVICE FROM SKIN
A. Remove the Patch(s) from the skin.
B. Remove the applicator from the sam Ultrasound Coupling Patch by pulling the
tab on the side of the gel cup. This unlocks the cup from the applicator (See
Figure 12).
C. Throw away the sam Patches.
Warning: NEVER use a sam Ultrasound Coupling Patch for more than one use.
Misuse of sam Ultrasound Coupling Patches or use for more than the
intended treatment duration MAY RESULT IN BURN OR REPEATED SHUTOFF
of the applicator.
12.3. CLEAN THE APPLICATORS
Clean any residual ultrasound coupling media off of the applicator and off of the skin.
See section 14 for ‘Cleaning and Maintenance’ details.
12.4. RECHARGE THE DEVICE
Connect the sam Power Controller to the sam Electrical Charger for recharging. Prior
to the next use, allow up to 6 hours to recharge the battery to 100% charge. See section
9 for charging instructions.
figure 12: Removing Applicator
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13. Modes of Operation
13.1. ON MODE
To turn the device ‘ON’ press and hold the Power Button for at least 1 second. Press
the Toggle Button on the right side of the sam Power Controller to set the treatment
duration. The treatment duration may be set for 1, 2, 3 or 4 hours. The battery indicator
LED and treatment timer LED will be displayed on the control panel (see section 8: LED
Display). The applicator indicator LED will be displayed on each attached applicator
(See Figure 2, page 10). Each connected applicator will emit ultrasound energy
immediately upon the sam Power Controller entering the ‘ON’ mode of operation. A
powered sam Applicator will always emit ultrasonic energy unless it enters the sam
Sensing Mode or the treatment duration concludes.
13.2. OFF MODE
When the device is ‘OFF’, the LEDs on the applicator will not be illuminated, the LEDs
on the sam Power Controller will not be illuminated, and no ultrasound energy will
emanate from the device. Always turn the device ‘OFF’ when not in use or if pain or
uncomfortable heating is indicated by the patient.
13.3. SAM SENSING MODE
In the event that the treatment site underneath the applicator reaches the temperature
threshold, the applicator will pause ultrasound output and vibrate once with a red LED
notification to signify that the device has begun a cooling or rest cycle. sam Applicator
will automatically resume treatment with a blue LED notification after the site
has cooled.
Warning: Should the patient ever report discomfort or a painful sensation from the site
under the sam Applicator, the applicator should be removed immediately.
Caution: At no time during treatment should the applicator be covered by thick
insulating material such as a coat, blanket or sports wrap. This may cause
sam to disable and remain disabled throughout the therapy session.
13.4. END OF TREATMENT MODE
At the end of treatment, an amber-colored “Treatment Complete” LED will illuminate
on the sam Power Controller and all other displays (battery indicator, treatment timer,
indicator LED, and applicator LEDs) will be inactive. All ultrasound emissions from
the applicator will cease. The “Treatment Complete” LED will remain illuminated for
approximately 8 hours after completion of therapy, at which point it will time out and
turn off. To set the sam Device for a new treatment, assess whether the sam Device
requires recharging.
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14. Cleaning and Maintenance
The exterior of the sam Power Controller and the applicator surfaces may be cleaned
with a soft cloth, tissue, or towel and one of the following cleaning agents: mild
detergent and water or disinfecting medical wipes.
Caution: Properly clean the applicator between treatments.
Caution: The device is not waterproof. Do not apply a direct stream of liquid onto the
device, submerge the device, or allow any liquid to pool on the surface of
the device.
Caution: DO NOT USE: Phenolic-based disinfectants, quaternary ammonium, chlorine-
based disinfectants, solvent-based cleaners, or abrasive materials. Doing so
may damage the plastic housing and void the warranty.
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15. Storage & Operating Conditions
15.1. STORAGE
Store the sam Device in the following conditions:
Temperature: 557°C;
Humidity: 1080%;
Atmospheric pressure range: 7001060 hPa
Store the sam Ultrasound Coupling Patches in the following conditions:
Temperature: 530°C;
Humidity: 1080%;
Atmospheric pressure range: 7001060 hPa
15.2. OPERATION
Only operate the sam Device in the following conditions:
Temperature: 144°C;
Humidity: 1080%;
Atmospheric pressure range: 7001060 hPa
Caution: Do not keep the device in extreme hot or cold temperatures (above 50°C or
below 0°C). Do not leave the sam Device in a hot or freezing car. Do not leave
the device in direct sunlight for extended periods. UV light may damage or
discolor the device.
16. Disposal of Waste Products
sam Ultrasound Coupling Patches are one time use and may be disposed of in regular
sanitation trash. No special disposal procedures are necessary.
Old, damaged or expired sam Power Controllers and applicators should be recycled or
returned to the manufacturer for proper disposal.
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17. Appendix
Li-ion
LOT
A. SYMBOLS
Consult User Manual/Instructions for Use
Manufacturer/Date of Manufacture
Lithium-ion battery inside
Class BF Applied Part
Do not use if package is damaged
Do not reuse
Non-ionizing radiation
Separate collection for electrical and electronic equipment.
be disposed of in unsorted municipal waste.
. Caution, consult accompanying documents
Diverging beam
Continuous wave (CW)
Use only with
W
Watts, ultrasonic power
MHz
Frequency in megahertz
ERA
Effective radiating area
BNR
Beam non uniformity ratio
Must not
Use by date
Temperature limit
Humidity limitation
SN
Serial number
Catalogue/Reorder Number
Lot Number
Atmospheric Pressure limitation
VO
Output Voltage
P
Acoustic Power
Ie
Average Intensity
f
awf
Frequency
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B. SPECIFICATIONS
The sam Device does not contain microprocessor or software to control function
Maximum Acoustic 0.65 W +20% per transducer
Power Output 1.3 W +20% for 2 transducers
Maximum Intensity 0.132 W/cm2 +20%
Frequency 3 MHz +20%
Duty Cycle 100% - continuous wave
Beam Form Wide Beam – 5 degree diverging lens
Individual Transducer Dimension 5 cm2 emitting surface area (circular)
BNR <5:1
2
ERA 6 cm
Maximum Treatment Duration 4 hours
Other Electrical Ratings for the sam Device Components
Electrical Charger (Model SINGOF10U050200)
Input Voltage 100240 V, 5060 Hz
Input Current 0.120.3 A
Output Voltage 4.755.25 V DC
Output Current 2.0 A
Max Output Power 10.5 W
+
20 %
Power Controller
Output Voltage 3.7 V DC +10%
Max Output Amperes 700 mA
Battery Protection Max Current: 2 Amps
Max Voltage: 4.2 V
Min Voltage: 3.1 V
Cable Voltage Rating 300 V
Cable 20°C Resistance: 94/km
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Applicator
Input Voltage: 3.7 V DC +10%
Ultrasound Frequency: 3 MHz +20%
Ultrasonic Output Power: 1 Transducer: 0.65 W +20%
2 Transducers Together: 1.3 W +20%
Max Input Current: 400 mA
YAdapter
Voltage Rating 300 V
20°C Resistance 94/km
C. NOTICE OF COMPLIANCE, CALIBRATION AND
OPERATIONAL PERIOD
The sam Device meets performance standards under 21 C.F.R. § 1050.10 PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATIONEMITTING PRODUCTS. The sam Device meets IEC 606011, 3 ed. (2012); IEC 6060112, 3 ed. (2007); Medical Electrical Equipment, General Requirements for Safety;
Electromagnetic Compatibility. The sam Device is calibrated to provide 3 MHz +20%
ultrasound diathermy at 0.65 W +20% per ultrasound applicator.
Operational Period:
The sam Power Controller is intended to maintain calibration for up to 300 charging
cycles and each ultrasound applicator is intended to withstand 1500 hours of run time,
after which the system should be recycled or returned to the manufacturer for proper
disposal.
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D. TECHNICAL INFORMATION
figure A. Ultrasound Field Scan Across Applicator Face
figure B. Ultrasound Field Scan Away From the Applicator Face
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E. ELECTRICAL IMMUNITY AND EMISSIONS
The following components of the sam Ultrasonic Diathermy Device are
compliant with the requirements of IEC 6060112 ed 3.0 (200703):
sam Model 271
Cable Length
AT271: Ultrasound Applicators
PC271: Power Controller 48 inches +1.2
CT271: Electrical Charger 70.8 inches +3.8
YB271: Y-branch Adapter 8 inches +.6 x 2
Guidance and Manufacturer’s Declaration – Emissions
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions Group 1 The sam uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF Emissions Class B The sam is suitable for use in all establishments,
CISPR 11 including domestic, and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Harmonics Class A
IEC 6100032
Flicker
IEC 6100033
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Guidance and Manufacturer’s Declaration – Immunity All
ME Equipment and ME Systems
The sam is intended for use in the electromagnetic environment
specified below. The customer or user of the sam should ensure
that it is used in such an environment.
Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level Environment - Guidance
ESD
IEC 6100042 +8kV Air
EFT 2kV Mains
IEC 61000044 +1kV IOs
or hospital environment.
Surge
IEC 6100045 +2kV Common Common NA that of a typical commercial or
(no ground) hospital environment.
Voltage >95% Dip for >95% Dip for Mains power quality should be
Dips/Dropout 0.5 Cycle 0.5 Cycle that of a typical commercial or
IEC 61000411 60% Dip for 60% Dip hospital environment. If the user
5 Cycles 5 Cycles of the sam requires continued
30% Dip for 30% Dip for operation during power mains
25 Cycles 25 Cycles interruptions, it is recommended
>95% Dip for >95% Dip for that the sam be powered from
5 Seconds 5 Seconds an uninterruptible power supply
or battery.
Power 3A/m 3A/m Power frequency magnetic fields
Frequency should be that of a typical
5060Hz commercial or hospital
Magnetic Field environment.
IEC 6100048
+
6kV Contact +6kV Contact Floors should be wood, concrete
+
8kV Air or ceramic tile. If floors are
synthetic, the r/h should be at
least 30%.
+
2kV Mains Mains power quality should be
+
1kV IOs that of a typical commercial
+
1kV Differential +1kV Differential Mains power quality should be
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Guidance and Manufacturer’s Declaration – Immunity
The sam is intended for use in the electromagnetic environment
specified below. The customer or user of the sam should ensure
that it is used in such an environment.
Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level Environment - Guidance
Portable and mobile communications
equipment should be separated from
the sam by no less than the distances
calculated/listed below:
Conducted RF 3 Vrms (V1) = 3 Vrms D = (3.5V1)(Sqrt P)
IEC 6100046 150 kHz to 150 kHz to 80 MHz
80 MHz
Radiated RF 3V/m D = (3.5Eq)(Sqrt P)
IEC 6100043 80 MHz to (E1) = 3 V/m 80 to 800 MHz
2.5 GHz
D=7E1)(Sqet P)
800 MHz to 2.5 GHz
Where P is the max power in watts and D
is the recommended separation distance
in meters.
Field strength from fixed transmitters,
as determined by an electromagnetic
site survey, should be less than the
compliance levels (V1 and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
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Recommended Separation Distances between portable and
mobile RF Communications equipment and the sam ME Equipment and
ME Systems that are NOT Life-supporting
The sam is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the sam can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF Communications Equipment and the sam as recommended below,
according to the maximum output power of the communications equipment.
Max Output Separation (m) Separation (m) Separation (m)
Power (Watts) 150kHz to 80MHz 80 to 800MHz 800MHz to 2.5GHz
D=3.5V1)(Sqrt P) D=3.5E1)(Sqrt P) D=3.5E1)(Sqrt P)
0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1.0 1.1667 1.1667 2.3333
10.0 3.6894 3.6894 7.3785
100.0 11.667 11.667 23.333
F. WARRANTY
ZetrOZ Systems offers a 1-year manufacturer’s warranty for the sam Device. If the
sam Device fails due to defects in material or workmanship, ZetrOZ Systems, at its
discretion, will:
1. REPAIR the sam Device OR
2. REPLACE the sam Device with another sam Device
THIS LIMITED WARRANTY AND ANY IMPLIED WARRANTIES THAT MAY EXIST UNDER
STATE LAW APPLY ONLY TO THE ORIGINAL PURCHASER OF THE sam DEVICE AND ARE
NONTRANSFERABLE.
Extent of Limited Warranty
This limited warranty does not cover damages due to external causes, including,
without limitation, accident, usage not in accordance with product instructions, misuse,
neglect, alteration or repair.
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G. TROUBLESHOOTING
Question or Problem Solution
1. How to determine if As confirmation that the device is delivering ultrasound,
the device is delivering the LEDs on the Power Controller will illuminate blue
treatment (treatment timer and indicator LEDs) and the indicator LED
on the applicator will illuminate blue. See section 8 on
LED Display.
2. The indicator LED on Ensure that the applicator is fully connected to the power
the Applicator does not controller wire jack and/or the Y-adapter wire jack. If
illuminate when the recently in sam Sensing Mode, ensure that the applicator
device is turned ON has had time to reach normal operating temperature and
the indicator LED on the applicator has turned from red
back to blue. If the applicator LED still fails to illuminate
blue, contact the manufacturer with serial and model
number details.
3. How to observe the The Battery Indicator display can only be viewed when
Battery level during the device is powered ON or OFF by pressing the Power
treatment Button, or when the Toggle Button is pressed. (See section
1 1.1) The lights remain illuminated for approximately 4
seconds after the device is turned ON or OFF. The Battery
Indicator LEDs do not remain illuminated during treatment.
The treatment duration is indicated by the blue treatment
timer LEDs (See section 8 on LED display).
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G. TROUBLESHOOTING
Question or Problem Solution
4. The Applicator is Turn off the device. Remove the sam Ultrasound Coupling
not staying secured Patch from the applicator. Replace with new sam
during treatment Ultrasound Coupling Patch. See section 11.3 for gel cup
application instructions.
5. The Applicators are The device has entered ‘sam Sensing Mode’ (See section
vibrating and red 13.4) Each sam Applicator is equipped with closed-loop
continuous temperature monitoring which maintains
treatment site temperatures below 44°C during normal
operation. In the event that the treatment site underneath
the applicator reaches the temperature threshold, the
applicator will pause ultrasound output and vibrate once
with a red LED notification that the device has begun
a cooling or rest cycle. sam will automatically resume
treatment with a blue LED notification after the site has
cooled. Caution: At no time during treatment should the
applicator be covered by thick insulating material such
as a coat, blanket or sports wrap. This may cause sam to
disable and remain disabled throughout the
therapy session.
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sam
0086
ZetrOZ Systems, LLC
56 Quarry Road
Trumbull, CT 0661 1
USA
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Toll Free Tel 18882029831
sam User Manual (OM271) — LL452600 Rev. A
Published 04042017
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