Sam sam-12 Directions For Use Manual Download Page 25 | Manualshive

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26

Product Support

203-349-2798

17. Appendix

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. Must not

be disposed of in unsorted municipal waste.

Caution, consult accompanying documents

Diverging

beam

Continuous wave (CW)

Watts, ultrasonic power

Frequency in megahertz

Eﬀ ective radiating area

Beam non uniformity ratio

Use by date

Temperature

limits

Humidity

limitation

Serial

number

Catalogue/Reorder

Number

Lot

number

A. SYMBOLS

Li-ion

W

MHz

ERA

BNR

SN

LOT

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Summary of Contents for sam-12

Page 1: ...Model sam 12 Ultrasonic Diathermy Device Directions for Use ...

Page 2: ... 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 a...

Page 3: ... 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 ...

Page 4: ...is 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 trea...

Page 5: ...ls 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 t...

Page 6: ...ormance 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 ...

Page 7: ...w 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 sa...

Page 8: ... 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 ...

Page 9: ... Connection Bottom Lock Switch Indicator LED HRS DONE 20 1 0 0 80 60 40 3 2 1 3 5 4 2 5 1 5 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 ...

Page 10: ...ndicator 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 attach...

Page 11: ...D 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 APPLICATO...

Page 12: ...URATION 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 recomme...

Page 13: ...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 fro...

Page 14: ...ors 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 use...

Page 15: ... 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...

Page 16: ... 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 DON E 20 100 80 60 40 3 2 1 3 5 4 2 5 1 5 ﬁgure 8 Connecting Y Adapter Rotate Clockwise ﬁgure 8B Gently twist to Lock 45 ﬁgure 8A Insert...

Page 17: ...el 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 a...

Page 18: ... 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 o...

Page 19: ...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...

Page 20: ...uration 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...

Page 21: ...ator See Figure 12 C Throw away the sam Bandages Warning NEVER use a sam Ultrasound Coupling Bandage for more than one use Misuse of sam Ultrasound Coupling Bandages 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 ...

Page 22: ...ment duration concludes 13 2 ON LOCKED MODE Once the device is powered ON the user may lock the control panel settings by sliding the Lock Switch on the sam Power Controller Module to the locked position as indicated by the lock symbol on the sam Power Controller Module This will prevent the device from unintentional shutoﬀ during treatment While locked the Power Button and the Toggle Button canno...

Page 23: ...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 remember to move the lock switch to the unlocked posi...

Page 24: ...rature 1 44 C Humidity 10 80 Atmospheric pressure range 700 1060 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 Bandages are one time use ...

Page 25: ...adiation Separate collection for electrical and electronic equipment Must not be disposed of in unsorted municipal waste Caution consult accompanying documents Diverging beam Continuous wave CW Watts ultrasonic power Frequency in megahertz Eﬀective radiating area Beam non uniformity ratio Use by date Temperature limits Humidity limitation Serial number Catalogue Reorder Number Lot number A SYMBOLS...

Page 26: ...ividual Transducer Dimension 5 cm2 emitting surface area circular BNR 5 1 ERA 6 cm2 20 Maximum Treatment Duration 4 hours Other Electrical Ratings for the sam Device Components Electrical Charger Model GS2U 006 050 A Input Voltage 100 240 V 50 60 Hz Input Current 0 2 A Output Voltage 5 V DC Output Current 1 2 A Max Output Power 6 W Power Controller Output Voltage 3 7 V DC 10 Max Output Amperes 700...

Page 27: ...ONIC INFRASONIC AND ULTRASONIC RADIATION EMITTING PRODUCTS The sam Device meets IEC 60601 1 3 ed 2012 IEC 60601 1 2 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 Module is intended to maintain...

Page 28: ...ct Support 203 349 2798 D TECHNICAL INFORMATION ﬁgure A Ultrasound Field Scan Across Applicator Face ﬁgure B Ultrasound Field Scan Away From the Applicator Face ﬁgure B Ultrasound Field Scan Away From the Applicator Face ...

Page 29: ...ches 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...

Page 30: ...of a typical commercial or hospital environment Surge 1kV Diﬀerential 1kV Diﬀerential Mains power quality should be IEC 61000 4 5 2kV Common Common N A 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 61000 4 11 60 Dip for 60 Dip hospital environment If the...

Page 31: ...rated from the sam by no less than the distances calculated listed below Conducted RF 3 Vrms V1 3 Vrms D 3 5 V1 Sqrt P IEC 61000 4 6 150 kHz to 150 kHz to 80 MHz 80 MHz Radiated RF 3V m D 3 5 Eq Sqrt P IEC 61000 4 3 80 MHz to E1 3 V m 80 to 800 MHz 2 5 GHz D 7 E1 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 ﬁ...

Page 32: ... 80MHz 80 to 800MHz 800MHz to 2 5GHz D 3 5 V1 Sqrt P D 3 5 E1 Sqrt P D 3 5 E1 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 Inc oﬀers a 1 year manufacturer s warranty for the sam Device If the sam Device fails due to defects in material or workmanship ZetrOZ Inc at its discretion will ...

Page 33: ...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 a...

Page 34: ...losed 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 w...

Page 35: ...sam Manufactured by ZetrOZ Inc 56 Quarry Road Trumbull CT 06611 USA Toll Free Tel 1 888 202 9831 USA User Manual OM 12 LL 2535 01 Rev B Published 06 04 2014 0086 ...

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