醫療器材安規測試儀

MI 6601 MediTest是一款新型Metrel測試儀，用於按照IEC / EN 60601標准在醫療設備生命週期的任何階段測試醫療設備的電氣安全。它對於開發工作來說足夠精確，為定型測試提供詳細的測量，它可以嵌入到生產線中，並且便於攜帶，可以根據 IEC 60601 或 IEC 62353 進行定期測試。此外，它還可以幫助診斷服務部門的問題或用於現場排除故障。

MI 6601 MediTest可作為獨立測試儀使用，現場無需PC或筆記本電腦。在辦公室和實驗室使用時，該測試儀可與Metrel醫用電氣安全管理器（MMESM）結合使用。它支持按照 IEC/EN 60601 和資產管理創建和執行測試序列。通過整合的線上服務Metrel Cloud Reports和Metrel Cloud Storage建立報告。符合IEC/EN 60601標準是一個被廣泛接受的標竿，亦為全球電氣醫療設備商業化的要求。在Metrel，我們相信我們新的MI 6601 MediTest是市場上最快和最容易使用的電氣安全符合性測試儀，它完全涵蓋了規定的標準測試程序，沒有任何妥協或簡化。

測量與檢驗

• 200 mAAC 和 25 AAC 下的PE電阻。
• 測試電壓 250 Voc 或 500 Voc 時的絕緣電阻。
• 支持符合IEC 62353標準的所有測試配置。
• 漏電流測量解析度為1 μA。
• 漏電流的AC、DC和TRMS值。
• IEC 60601-1 標準中定義的所有漏電流測量（患者、輔助、接地、觸摸）。
• IEC 62353 中定義的所有漏電流測量（設備和應用部分；替代法、直接法、差分法）。
• 根據可攜式設備標準 EN 50678 和 EN 50699 進行測量。
• 點對點、觸摸和電源電壓測試。
• 設備功率。
• IEC引線測試。
• 預設或可配置的目視和功能檢查。

主要特點

• 市場上最完整的IEC 60601測試儀。
• 110 種通用可配置連接。它們可以配置為應用部分、非接地部分、接地部分。
• 用於連接功能接地和信號輸入/輸出連接的專用測試埠。。
• 所有可能的配置均符合IEC 60601和IEC 62353標準。
• 測試可直接在儀器上進行，也可通過電腦進行。
• 通過Auto Sequences®實現全自動測試流程。
• 根據醫療設備的設定配置自動設置測試和限制值。
• 測試序列經過最佳化，可實現最快速的工作流程。
• 支持IEC/EN 60601（第2版和第3版）、IEC/EN 62353、ANS/NZS 3551、EN 50678和EN 50669標準的測量。。
• 使用單一測試即可輕鬆診斷問題。 
• 用於測試 PE 連接連續性的高電流：最高 25 A。
• 流經患者之漏電流和流經患者輔助電流的交流和直流電流值。
• 通過USB、RS232和乙太網通訊。
• 以任意方式輸入數據：觸控式螢幕、條碼/二維條碼掃描器、無線鍵盤、電腦軟體。。
• 選購的列表機或 NFC 寫入器用於創建標籤和標記。。
• 新的訂購型軟體解決方案，包括MMESM、Metrel雲端報告和Metrel雲端存儲。
• IP40防護等級 ( 外蓋打開時 )，IP65防護等級可 ( 外蓋 閉合時 )。
• 攜行箱和附件袋。

應用

• 醫療設備在研發、生產、服務和定期驗證過程中的安全性。
• 醫療設備的故障排除。
• 標準可攜式設備的安全性。
• 可攜式設備的故障排除。

MI 6601 MediTest is a new Metrel tester for testing the electrical safety of medical equipment in the accordance with the IEC / EN 60601 standard in any stage of medical equipment life cycle. It is accurate enough for development work, offers detailed measurements for type testing, it can be embedded into the production line and is portable enough for recurrent testing in accordance with IEC 60601 or IEC 62353. In addition it can help with diagnosing problems in service departments or can be used for troubleshooting in the field.

The MI 6601 MediTest can be used as stand-alone tester without a PC or laptop in the field. For office and laboratory use, the tester can work in combination with Metrel Medical Electrical Safety Manager (MMESM). It supports creation and execution of test sequences in accordance with IEC/EN 60601 and asset management. Reports are created with integrated online services Metrel Cloud Reports and Metrel Cloud Storage. Compliance with IEC/EN 60601 is a widely accepted benchmark and a requirement for commercialisation of electrical medical equipment around the world. In Metrel we believe that our new MI 6601 MediTest is the fastest and easiest-to-use electrical safety compliance tester on the market, which entirely covers prescribed standard test procedures, without any compromises or simplifications.

MEASUREMENTS AND INSPECTIONS

• PE resistance with 200 mAAC and 25 AAC .
• Insulation resistance with test voltage 250 Voc or 500 Voc.
• All test configurations acc. to IEC 62353 are supported.
• Leakage current measurements with 1 μA resolution.
• AC, DC and TRMS value of leakage currents.
• All leakage current measurements as defined in IEC 60601-1 standard (patient, auxiliary, earth, touch).
• All leakage current measurements as defined in IEC 62353 (equipment and applied part; alternative, direct, differential method).
• Measurement according to portable appliance standards EN 50678 and EN 50699.
• Point-to-point, touch and mains voltage tests.
• Equipment power.
• IEC lead test.
• Pre-set or configurable visual and functional inspections.

KEY FEATURES

• The most complete IEC 60601 tester on the market.
• 10 universal configurable connections. They can be configured as applied parts, non-earthed parts, earthed parts.
• Dedicated test ports for connection to functional earthing and signal I/O connections.
• All possible configurations acc. to the IEC 60601 and IEC 62353 standards.
• Tests can be run on the instrument directly or via a PC.
• Fully automatic test flow with Auto Sequences®.
• Tests and limits are automatically set acc. to the set configuration of medical equipment.
• Test sequences are optimized for fastest work flow.
• Supports measuring by standards IEC/EN 60601 (2nd and 3rd editions), IEC/EN 62353, ANS/NZS 3551, EN 50678 and EN 50669.
• Use of single tests to diagnose problems easily.
• High current for testing continuity of PE connections: up to 25 A.
• AC and DC values of patient leakage and patient auxiliary current.
• Communication over USB, RS232 and Ethernet.
• Input data in any desired way: touchscreen, barcode/QR code scanner, wireless keyboard, PC SW.
• Optional printers or NFC writers for creating labels and tags.
• New subscription-based software solution including MMESM, Metrel Cloud Reports and Metrel Cloud storage.
• IP 40 case open, IP 65 case closed.
• Carrying case and bag for accessories.

APPLICATIONS

• Safety of medical equipment during development, production, service, periodic verification.
• Troubleshooting of medical equipment.
• Safety of standard portable appliances.
• Troubleshooting portable devices.