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Product Support

1-888-202-9831

•

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

Содержание 271

Страница 1: ...Directions for Use Model sam 271 ...

Страница 2: ...Product Support 1 888 202 9831 sam ...

Страница 3: ...play 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 Ele...

Страница 4: ...pling 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 de...

Страница 5: ...ted 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 Ul...

Страница 6: ...nal 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 d...

Страница 7: ...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 ...

Страница 8: ... 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 COUPLIN...

Страница 9: ...Model 271 Components AT 12 YB 12 UB 12 AT 12 YB 12 if included AT 12 YB 12 5 sam Components sam MODEL 271 COMPONENTS AT271 Ultrasound Applicators UB 14 Ultrasound Coupling Patches OM271 User Manual PC271 Power Controller CT271 Electrical Charger YB271 Y branch Adapter PC271 UB 14 AT271 YB271 CT271 AT271 ...

Страница 10: ...cator Connection Bottom Indicator LED 4 HRS 3 2 1 DONE B A T T E R Y C H E C K 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 Patches may be obtained by contacting the manufacturer 6 Operator Interface ...

Страница 11: ...f 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 att...

Страница 12: ...attery 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 Co...

Страница 13: ...trasonic 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 wi...

Страница 14: ...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 fr...

Страница 15: ...licators 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 u...

Страница 16: ... 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 ...

Страница 17: ...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 4 HR S 3 2 1 DO NE B A T T E R Y C H E C K figure 8 Connecting Y Adapter 45 Rotate Clockwise figure 8B Gently twist to Lock 45 Rotate Clockwise fi...

Страница 18: ... 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 e...

Страница 19: ... 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 ot...

Страница 20: ...or 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 treat...

Страница 21: ...e 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 Wa...

Страница 22: ...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 de...

Страница 23: ...tient 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 ...

Страница 24: ...infecting 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...

Страница 25: ... Temperature 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 Patches are one time...

Страница 26: ...c equipment Must not be disposed of in unsorted municipal waste Caution consult accompanying documents Diverging beam Continuous wave CW Use only with Watts ultrasonic power Frequency in megahertz Effective radiating area Beam non uniformity ratio Use by date Temperature limit Humidity limitation Serial number Catalogue Reorder Number Lot Number Atmospheric Pressure limitation Output Voltage Acous...

Страница 27: ... Individual 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 SINGOF 10U 050200 Input Voltage 100 240 V 50 60 Hz Input Current 0 12 0 3 A Output Voltage 4 75 5 25 V DC Output Current 2 0 A Max Output Power 10 5 W Power Controller Output Voltage 3 7 V DC 10...

Страница 28: ...SONIC 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 is intended to maintain calib...

Страница 29: ...29 ZetrOZ Systems Product Support 1 800 202 9831 D TECHNICAL INFORMATION figure A Ultrasound Field Scan Across Applicator Face figure B Ultrasound Field Scan Away From the Applicator Face ...

Страница 30: ... 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 domes...

Страница 31: ...at 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 I...

Страница 32: ...arated 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 ...

Страница 33: ...0MHz 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 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 discretio...

Страница 34: ...ng 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...

Страница 35: ...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 ...

Страница 36: ...sam ZetrOZ Systems LLC 56 Quarry Road Trumbull CT 06611 USA MDSS GmbH Schiffgraben 41 30175 Hannover Germany Toll Free Tel 1 888 202 9831 sam User Manual OM271 LL 4526 00 Rev A Published 04 04 2017 0086 ...

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