Zimmer SonoOne Instructions For Use Manual
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使用說明書
Instructions for Use
SonoOne
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EN
中文

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Summary of Contents for Zimmer SonoOne

  • Page 1 使用說明書 Instructions for Use SonoOne 中文...
  • Page 2: Explanation Of Symbols

    The instructions for use are valid as of June 2018. 用途 Indended Use SonoOne 是一款超聲波治療儀器,利用超聲波將組織加熱,以治療肌肉骨骼系統的疾病。 SonoOne is an ultrasound therapy device for application of ultrasound in order to heat tissue for purposes of treatment of diseases of the musculoskeletal system.
  • Page 3: Indications / Contraindications

    適應症 / 禁忌症 Indications / Contraindications 適應症 · Indications 為患有肌肉骨骼系統疾病 (例如肌腱病變、關節疾病) 的組織進行熱療。 Heating tissue in cases of diseases of the musculoskeletal system e.g. Epicondylopathy, Joint diseases. 禁忌症 · Contraindications • 有不明痛症的人士 • Vague pain symptoms • 不能使用熱療的疾病,例如急性炎性 • Diseases where heat should not be used, for example, acute inflammatory diseases 疾病...
  • Page 4: Application Information

    使用資訊 Application information Caution 注意 為避免觸電,保養或清潔工作前,請拔除插頭,切斷電源。 To avoid the risk of electric shock, disconnect the device from the mains supply by pulling the plug before carrying out any maintenance or cleaning work. 使用前,請確保使用有接地的插座及插頭為儀器供電 (根據DIN VDE 0100-710的電器安裝)。 必須使用附設的電源線來操作儀器,並必須保護電源線免受機械壓力。 Before use, ensure that the device is powered via a properly earthed plug with a grounded outlet (electrical installation according to DIN VDE 0100 Part 710).
  • Page 5 使用資訊 Application information 只可使用Zimmer MedizinSysteme GmbH提供的配件。 Only accessories provided by Zimmer MedizinSysteme GmbH are to be used. 本儀器可能會導致附近的儀器故障或干擾其運作。 你可能需要採取相應的應對措施,例如 重新擺放或調整本儀器或加設屏障。 The device may cause malfunctions or may interfere with the operation of equipment in the vicinity. It may be necessary to take appropriate remedial action, such as realignment, re-arrangement of the device or installation shielding.
  • Page 6 警告 Warnings 必須按照本說明書指定的設定及用途使用,否則可能會導致超聲波能量不受控制地釋放, 而造成危險。 The use of this product with settings or for applications other than those specified in the user manual may lead to hazards resulting from the uncontrolled release of ultrasound energy. 任何有關治療位置、時間及強度的治療指引,必須遵守本說明書的指引使用。 Strictly follow the instructions in this manual for any treatment instructions regarding treatment location, duration and intensity.
  • Page 7: Display Views

    顯示視圖 Display views 圖1 程式介面 圖2 治療介面 Fig. 1 Programme Screen Fig. 2 Therapy Screen 圖3 配置介面 圖4 參數介面 Fig. 3 Configuration screen Fig. 4 Parameter screen...
  • Page 8: Description Of The Functions

    功能說明 Description of the functions 圖5 開關及連接插頭 圖6 超聲波頭 圖7 超聲波頭連插座 Fig. 5 Switches and connector sockets Fig. 6 Ultrasound head Fig. 7 Ultrasound head with holder 屏幕、顯示器、視窗及按鈕說明 Description of screens, displays, windows, buttons 注意:直接用手指在屏幕上操作所有視窗和按鈕。 Note: Activate all windows and buttons by pressing directly on the screen with your finger. 程式介面...
  • Page 9 功能說明 Description of the functions 耦合 調整極限耦合值 上/下聲量 調整訊號聲量 Coupling Adjustment of the limit Up / down sound Adjustment of signal coupling value sound 顯示設置 (W, W /cm² 強度 訊息 顯示軟件版本 Information Displays the software 或W + W /cm²) version Intensity Setting of display (W, W /cm²...
  • Page 10: Technical Information

    技術資料 Technical information 100-240 V / 50 Hz / 60 Hz Mains voltage 100 - 240 V / 50 Hz / 60 Hz 電源電壓 220 V / 60赫茲 220 V / 60 Hz 60 VA Power Consumption max. 60 VA 耗電功率...
  • Page 11: Cleaning / Disinfection

    清潔 / 消毒 Cleaning / Disinfection 保養和清潔前,必須關掉儀器的總掣,並且拔除電線。 Before starting any maintenance and cleaning measures the device must always be switched off at the main switch and the mains cable must be disconnected. 清潔或消毒過程中,須確保沒有液體滲入儀器。不要使用噴霧劑。 Make sure that during cleaning or disinfection no liquid penetrates the device. Do not use sprays. 萬一清潔或消毒過程中,有液體滲入儀器,請立即停止使用,不要再啟動儀器,並聯絡顧...
  • Page 12 清潔 / 消毒 Cleaning / Disinfection 消毒:建議每周至少進行一次消毒,以及檢查是否有受污染跡象,詳情請諮詢衞生專家。 請先清潔表面再進行消毒。 可以使用消毒濕巾消毒外殼及所有電線。請使用市面上不含酒精,且有殺菌、消毒及殺真 菌功效的金屬及塑料消毒劑。 請遵守製造商的使用說明。 參考生產商的指引,選擇消毒劑,將軟布浸入消毒劑,但注意不要過濕,拭擦整個表面, 或使用消毒濕巾拭擦。 請遵守風乾或清潔後的要求 (如適用)。 Disinfection: We recommend that disinfection is to be carried out at least once a week, as well as if there is any indication of contamination. Consult with your hygiene specialist when doing so. Always perform cleaning prior to disinfection.
  • Page 13 歐洲合格認證 CE mark The devices have a CE mark 本儀器持有CE標誌 0123 0123 in accordance with the EC directive on medical 符合醫療設備93/42/EEC指令。 devices 93/42/EEC.
  • Page 14: Scope Of Delivery / Accessories

    3 MHz, 5 cm² 1條電線 53 601 100 1 holder for ultrasound head 1瓶SonoPlus 1 mains cable 10 102 642 1使用說明 1 bottle SonoPlus 10 102 642 1 instructions for use 組合方式 Combinations SonoOne不適用於與其他儀器組合。 SonoOne is not intended for combination with other devices.
  • Page 15 錯誤訊息 / 功能測試 / 法律聲明 / 棄置 Error Messages / Functional test / Legal Notices / Disposal 錯誤代碼列表 224/1通訊錯誤 402/2超聲波治療頭過熱 407/2 PLL故障 406/2超聲波頭未接觸 410/2輸出電壓異常 某些情況下,重新啟動電源可解決問題。只能由專業人員維修。另提供服務手冊。 功能測試 用耦合凝膠覆蓋超聲波頭,設定強度,開始治療,耦合值必須達90 %以上。 Error Code list 224/1 Communication Error 402/2 Ultrasound applicator has overheated 407/2 PLL fault 406/2 Ultrasound head not connected 410/2 Output Voltage abnormal In some cases switching the device on an off may solve the problem.
  • Page 16 棄置時,必須將本儀器連同原廠包裝退還給Zimmer MedizinSysteme。 在國外使用 (德國以外),請參照國家的棄置法例。如有必要,請聯絡分銷商。 SonoOne is not listed in Annex 1 of MPBetreibV. The device is not listed in Annex 2 of MPBetreibV. In Germany, the DGUV regulation 3 (Electrical Systems and Equipment) in its current version must also be observed.
  • Page 17: Manufacturer's Emc Declaration

    文件中包含的EMC訊息進行安裝和調試。 Medical electrical equipment such as the SonoOne are subject to special precautions with regard to EMC (electromagnetic compatibility) and must be installed and commissioned in accordance with the EMC information contained in the user manual or the accompanying documents.
  • Page 18 Recommended separation distances between portable and mobile RF communications equipment and the SonoOne device The SonoOne device is intended for use in an electromagnetic environment in which RF disturbances are controlled. The customer or the user of the SonoOne device can thus help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SoleoOne device –...
  • Page 20 SonoOne 使用說明書 Instructions for Use * 如中、英文兩個版本有任何抵觸或 不相符之處,應以英文版本為準。 * If there is any inconsistency or ambiguity between the English version and the Chinese version, the English version shall prevail. 電子產品網上保養登記請到: Online Warranty Registration for Electrical Product at: http://www.healthcarehk.com 服務熱線 Service Hotline:(852) 2810 4868 地址:香港新界葵涌工業街23-31號美聯工業大廈21樓B室...

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