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Sam 271 Directions For Use Manual

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Directions
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Model sam-271

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Summary of Contents for Sam 271

  • Page 1 Directions for Use Model sam-271...
  • Page 2 Product Support 1-888-202-9831...

  • Page 3: Table Of Contents

    Contents Introduction .............................. 4 Indications for Use ..........................4 Safety ................................5 3.1. Contraindications ........................... 5 3.2. Warnings ..............................5 3.3. Precautions ............................... 6 Features of the Device ......................8 Components ..........................9 Operator Interface ..........................10 Accessories ............................10 LED Display ..............................

  • Page 4: Introduction

    1. Introduction Thank you for choosing ! This manual contains general instructions for operation, application, precautions, and maintenance. In order to obtain maximum life and efficiency from the 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.

  • Page 5: Safety

    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 •...

  • Page 6: Precautions

    • DO NOT administer treatment if the applicator is not connected to a Ultrasound Coupling Patch. • Applicators and Ultrasound Coupling Patches are not sterile. DO NOT apply this device over an open wound or inflamed skin. • DO NOT use the Ultrasound Coupling Patch if the Ultrasound Media is dried out.
  • Page 7 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.

  • Page 8: Features Of The Sam Device

    44°C during normal operation. See section 13.4 on page 24 for more information. 4.4. sam ULTRASOUND COUPLING Patches Device utilizes ultrasound coupling Patches which are manufactured with ultrasound coupling media sealed inside. The ultrasound coupling Patches ARE REQUIRED to secure the Applicators to the body.

  • Page 9: Sam Components

    UB-14 DONE YB271 YB-12 CT271 if included AT271 AT271 AT-12 AT-12 YB-12 YB-12 figure 1: sam Model 271 Components sam MODEL 271 COMPONENTS AT271: Ultrasound Applicators UB-14: Ultrasound Coupling Patches OM271: User Manual PC271: Power Controller CT271: Electrical Charger YB271:...

  • Page 10: Operator Interface

    Connection Bottom figure 2: sam Interface Components 7. Accessories Device may be used with any of the following accessories: Belt Clip Armband Carrying Case * Additional sam Ultrasound Coupling Patches may be obtained by contacting the manufacturer Product Support 1-888-202-9831...

  • Page 11: Led Display

    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 Too many applicators are attached.
  • Page 12 Applicator is receiving power from the Power Controller. Ultrasonic energy is being generated at all times this light is illuminated sam Sensing Mode. No Ultrasonic energy Red (accompanied by vibration) is being generated from this applicator while this light is illuminated Table 4.

  • Page 13: Initial Setup Instructions

    Device arrives only partially charged due to generally accepted shipping practices. Micro USB 9.1. CHARGING THE POWER Bottom of sam Power Controller CONTROLLER figure 3A A. Peel back the dust cover on the bottom Wall Charger Bottom of sam Power Controller...
  • Page 14 10.2. TREATMENT LOCATIONS Figures 4 and 5 depict examples of device placement on two treatment locations. Figure Shoulder 4A and 4B illustrates using the Device with one applicator on the shoulder and knee. Figure 5A and 5B illustrates using the Device with two applicators on the shoulder and knee.
  • Page 15 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 Applicators and two Ultrasound Coupling Patches...

  • Page 16: Application Instructions

    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 Power Controller to view the battery indicator lights (Figure 7). The lights will illuminate to show how much battery life is remaining Toggle in the device.
  • Page 17 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.
  • Page 18 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).
  • Page 19 11.4. APPLY ULTRASOUND 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 Coupling Media as needed.
  • Page 20 11.5. TURN THE DEVICE ‘ON’ Power Button A. Press and hold the Power Button on the 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 Power Controller will illuminate blue (treatment timer and DONE...
  • Page 21 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.

  • Page 22: Device Power Down And Removal

    12. Device Power Down and Removal 12.1. POWER OFF THE POWER CONTROLLER Press and hold the Power Button on the 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.

  • Page 23: Modes Of Operation

    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.

  • Page 24: Cleaning And Maintenance

    14. Cleaning and Maintenance The exterior of the 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.

  • Page 25: Storage And Operating Conditions

    15.1. STORAGE Store the sam Device in the following conditions: Temperature: 5-57°C; Humidity: 10-80%; Atmospheric pressure range: 700-1060 hPa Store the sam Ultrasound Coupling Patches in the following conditions: Temperature: 5-30°C; Humidity: 10-80%; Atmospheric pressure range: 700-1060 hPa 15.2. OPERATION Only operate the sam Device in the following conditions: Temperature: 1-44°C;...

  • Page 26: Appendix

    17. Appendix A. SYMBOLS Consult User Manual/Instructions for Use Manufacturer/Date of Manufacture Lithium-ion battery inside Li-ion 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.

  • Page 27: Specifications

    B. SPECIFICATIONS Device does not contain microprocessor or software to control function 0.65 W + 20% per transducer Maximum Acoustic 1.3 W + 20% for 2 transducers Power Output + 20% Maximum Intensity 0.132 W/cm 3 MHz + 20% Frequency Duty Cycle 100% - continuous wave Beam Form...

  • Page 28: Notice Of Compliance, Calibration And Operational Period

    Applicator 3.7 V DC + 10% Input Voltage: 3 MHz + 20% Ultrasound Frequency: 1 Transducer: 0.65 W + 20% Ultrasonic Output Power: 2 Transducers Together: 1.3 W + 20% Max Input Current: 400 mA Y-Adapter Voltage Rating 300 V 20°C Resistance 94/km C.

  • Page 29: Technical Information

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

  • Page 30: Electrical Immunity And Emissions

    E. ELECTRICAL IMMUNITY AND EMISSIONS The following components of the sam Ultrasonic Diathermy Device are compliant with the requirements of IEC 60601-1-2 ed 3.0 (2007-03): sam Model 271 Cable Length AT271: Ultrasound Applicators 48 inches + 1.2 PC271: Power Controller 70.8 inches + 3.8...
  • Page 31 Guidance and Manufacturer’s Declaration – Immunity All ME Equipment and ME Systems is intended for use in the electromagnetic environment specified below. The customer or user of the should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic...
  • Page 32 Guidance and Manufacturer’s Declaration – Immunity 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...

  • Page 33: Warranty

    Recommended Separation Distances between portable and mobile RF Communications equipment and the ME Equipment and ME Systems that are NOT Life-supporting is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the...

  • Page 34: Troubleshooting

    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.
  • Page 35 G. TROUBLESHOOTING Question or Problem Solution 4. The Applicator is Turn off the device. Remove the Ultrasound Coupling not staying secured Patch from the applicator. Replace with new during treatment Ultrasound Coupling Patch. See section 11.3 for gel cup application instructions. 5.
  • Page 36 ZetrOZ Systems, LLC 56 Quarry Road Trumbull, CT 06611 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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