Sam sam-12 Manual

Model sam-12
Ultrasonic
Diathermy
Device
Directions
for Use

3ZetrOZ, Inc.
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

4Product Support 203-349-2798
1. Introduction
Thank you for choosing the sam Ultrasonic Diathermy Device! 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 Bandages.
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 decals placed on the device. Periodically review the operation procedures
and safety precautions outlined in this manual.
1.2. 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.

5ZetrOZ, Inc. Product Support 203-349-2798
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.
• If the Lock Switch is in the locked position it must be placed in the unlocked
position to disable the power. Locking the treatment settings is optional and not
required for treatment.
• ALWAYS administer treatment using a new sam Ultrasound Coupling Bandage.
Use one sam Ultrasound Coupling Bandage per applicator. Use of the sam
Ultrasound Applicator without a new sam Ultrasound Coupling Bandage MAY
RESULT IN BURN and/or REPEATED SHUTOFF of the sam Applicator.
• The sam Device should be kept out of the reach of children.

6Product Support 203-349-2798
• DO NOT apply the sam Applicator with alternative coupling media as a
replacement for the sam Ultrasound Coupling Bandage. Use of alternative
coupling media in lieu of the sam Ultrasound Coupling Bandages may reduce
the effectiveness of treatment, lead to automatic shutoff of the applicator, or
cause a burn.
• DO NOT administer treatment if the applicator is not connected to a sam
Ultrasound Coupling Bandage.
• Applicators and sam Ultrasound Coupling Bandages are not sterile. DO NOT
apply this device over an open wound or inflamed skin.
• DO NOT use the sam Ultrasound Coupling Bandage if the sam Ultrasound
Media is dried out. Indications of a dried out bandage 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 bandage 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 Bandage, 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

7ZetrOZ, Inc. Product Support 203-349-2798
3.5. ELECTRONICS AND BATTERY
WARNINGS
• This device is rated IPX0; 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.

8Product Support 203-349-2798
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 BANDAGES
The sam Device utilizes ultrasound coupling bandages which are manufactured with
ultrasound coupling media sealed inside. The ultrasound coupling bandages 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.
4.6. LOCK SWITCH
The sam Power Controller Module includes a slide lock switch that allows the locking
of treatment settings so that they cannot be inadvertently modified during a 1 – 4 hour
treatment session. Locking the sam Power Controller Module will disable both the
treatment time toggle button and the power ONOFF button. To disable the device or
modify treatment time once in locked mode, the lock switch must be moved to the
unlocked position. Similarly, the device cannot be turned on while in locked mode and
must be unlocked first. The use of the locking feature is OPTIONAL.

9ZetrOZ, Inc. Product Support 203-349-2798
HRS
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figure 1: sam Model-12 Components
AT-12
YB-12
if included
AT-12
5. sam Components
sam MODEL 12 COMPONENTS
AT-12: Ultrasound Applicators
UB-12: Ultrasound Coupling Bandages
OM-12: User Manual
PMC-12: Power Controller Module
CT-12: Electrical Charger
YB-12: Y-branch Adapter
PMC12 UB12
AT12
YB12
CT12
AT12

10 Product Support 203-349-2798
3
3.5
2.5
Front
Indicator LED
Treatment
Timer LED
Power Button
Battery
Indicator LED
Side
Toggle
Button
Charge Port Applicator
Connection
Bottom
Lock Switch
Indicator LED
HRS
DONE
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figure 2: sam Interface Components
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 Bandages may be obtained by contacting
the manufacturer
6. Operator Interface

11ZetrOZ, Inc. Product Support 203-349-2798
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

12 Product Support 203-349-2798
8.2. CONTROL PANEL
The front face of the sam Power Controller Module 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 and
will count down in 30 minute 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

13ZetrOZ, Inc. Product Support 203-349-2798
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 MODULE
A. Plug the micro USB end of the sam
Electrical Charger into the charging port on
the bottom of the sam Power Controller.
B. Plug the electrical charger into a 120/230
VAC wall outlet. The sam Power Controller
Module indicator LED will be amber. When
the device is fully charged the top right
indicator LED will change from amber
to green.
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 module if needed.
Bottom of sam Power Controller
Micro USB
Wall Charger
Outlet
figure 3B
figure 3A
9. Initial Setup Instructions

14 Product Support 203-349-2798
10.2. TREATMENT LOCATIONS
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.
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. SINGLE-APPLICATOR 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.
Knee
Shoulder
figure 4A: Single Shoulder Application
figure 5A: Dual Shoulder Application
figure 5B: Dual Knee Application
figure 4B: Single knee Application

15ZetrOZ, Inc. Product Support 203-349-2798
10.3.2. DUAL-APPLICATOR 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 Bandages
simultaneously, the sam Ultrasound Coupling Bandages should be positioned so that
their footprints do not overlap.
Caution: DO NOT overlap sam Ultrasound Coupling Bandages (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 Bandages (one for
each applicator) and the Y-adapter must be used for the treatment.
figure 6: NO Bandage Overlap

16 Product Support 203-349-2798
11.1. CHECK DEVICE CHARGE
A. To prevent accidental activation during
shipping, the device will arrive to the user
in the ‘locked’ position. To unlock the
device, slide the Lock Switch on the sam
Power Controller ‘up’ into the ‘unlocked’
position (Figure 7A).
B. 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 7B). 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.
Lock
Switch
figure 7A: Check Device Charge
figure 7B: Check Device Charge
Toggle
Button
11. Application Instructions

17ZetrOZ, Inc. Product Support 203-349-2798
11.2. CONNECT APPLICATOR TO POWER CONTROLLER
* 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).
HRS
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figure 8*: Connecting Y-Adapter
Rotate Clockwise
figure 8B: Gently twist to Lock
45
figure 8A: Insert power controller wire at 450angle

18 Product Support 203-349-2798
11.3. ATTACH APPLICATOR TO BANDAGE
A. Remove the circular seal from the top of
the bandage to reveal the coupling media
within the gel cup (Figure 9A).
B. Attach the applicator, face down, into the
coupling media (Figure 9B).
C. 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 bandage.
Note: When the applicator is pressed down onto
the gel cup, 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.
Note: Ensure the applicator is fully attached to
the bandage.
figure 9A: Removing Foil Seal
figure 9B: Attach Applicator
figure 9C: Press Applicator Down

19ZetrOZ, Inc. Product Support 203-349-2798
11.4. APPLY ULTRASOUND
COUPLING BANDAGE TO
TREATMENT LOCATION
A. Hold the applicator so the bottom of the
bandage faces up. Remove the paper liner
from the back of the bandage, revealing
the bandage adhesive (Figure 10A).
i. The circular seal should peel off the
bottom of the gel cup along with the
paper bandage liner. If it does not peel
with the paper, be sure to peel away
the circular seal so the coupling media
is completely uncovered.
ii. Add more sam Coupling Media
as needed.
B. Turn the bandage over and adhere the
bandage 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 bandage and applicator to the
second treatment site.
Note: When applying bandages, 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
Knee
figure 10B: Adhere Bandage to Site

20 Product Support 203-349-2798
11.5. TURN THE DEVICE ‘ON’
A. Check to make sure the Lock Switch is in
the ‘unlocked’ position (Figure 11A).
B. Press and hold the Power Button on
the sam Power Controller for at least 1
second to turn the device ‘ON’ (Figure 11B).
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.
C. Press the Toggle Button to select 1, 2, 3 or
4 hour treatment duration (as allowed by
current battery charge) (Figure 11C).
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.
Lock
Switch
Toggle
Button
Lock
Switch
figure 11A: Slide to Unlocked Position
figure 11C: Select Duration
Toggle
Button
Power Button
1
2.5
1.5
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figure 11B: Press Power Button

21ZetrOZ, Inc. Product Support 203-349-2798
11.6. PREVENT UNINTENTIONAL SHUTOFF
Once satisfied with the treatment settings, the
settings may be locked to prevent unintentional
shutoff during treatment by sliding the Lock Switch
down into the ‘locked’ position as indicated by
the symbols on the sam Power Controller (see
Figure 11A). In this state the settings cannot be
changed until the Lock Switch is moved back to the
‘unlocked’ position.
Note: The system is not required to be locked in
order to operate. Always be aware of how
to disable a locked device. Always notify the
patient if their device is locked.
11.7. TREATMENT DELIVERY
Treatment will be delivered for the duration set by
the user. The treatment timer LEDs will count down
in 30 minute 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: If the sam Lock Switch is in the locked position, the sam Power Button will
not turn off the device until the sam Lock Switch is placed into the
unlocked position.
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.