MISONIX

BoneScalpel System Model BCM-SY Instructions for Use Rev G

Instructions for Use

54 Pages

Instructions For Use  BoneScalpel™ with SonicOne® Technology  Table of Contents 1. General Safety Statements... 3 1.1. EMC Statement ... 3 1.2. Electrical Safety Statement ... 6 1.3. Environmental Statement ... 6 1.4. Summary Of Safety Notices ... 7 1.5. Trademark Information ... 10 1.6. Explanation Of Symbols ... 11 2. Indications And Contra Indications ...12 2.1. Indications ... 12 2.2. Contra Indications ... 12 3. Adverse Effects ...13 4. Considerations During Clinical Use ...14 4.1. HARD Tissue Use ... 15 4.2. SOFT Tissue Use ... 16 5. System Overview ...17 5.1. Principle Of Operation ... 17 5.2. Reusable System Components ... 18 5.3. Single-use, Sterile Components ... 19 6. Console ...21 6.1. Receptacles, Controls And Indicators ... 21 6.2. Menu Functions ... 22 6.3. Main Functions... 24 6.4. Alerts And Indicators ... 26 7. System Set-up ...28 7.1. Installation ... 28 7.2. Console Set-up – Part I (Non-sterile) ... 29 7.3. Handpiece Assembly (Sterile)... 29 7.4. Console Set-up – Part II (Non-sterile) ... 30 7.5. Perform System Check ... 32 8. Handpiece Assembly And Disassembly By Application ...33 8.1. Handpiece Assembly - HARD Tissue Use ... 33 8.2. Handpiece Disassembly - HARD Tissue Use ... 35 8.3. Handpiece Assembly - SOFT Tissue Use ... 36 8.4. Handpiece Disassembly - SOFT Tissue Use ... 38 9. Cleaning And Sterilization ...40 9.1. Disassembly ... 40 9.2. Cleaning ... 40 9.3. Sterilizing By Steam Autoclave ... 42 9.4. Expected Life, Reusable Components ... 43 9.5. Deviations From Decontamination, Cleaning And Sterilization Instructions ... 43 10. Troubleshooting ...44 11. Specifications ...47 12. Service, Repair And Technical Correspondence ...49 12.1. Fuse Replacement ... 49 12.2. Pump Head Replacement... 50 12.3. Repair, Service and Replacement Parts ... 50 12.4. Important Notice... 51  BCM-UM Rev G  Page 2
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File Name: MISONIX - BoneScalpel System Model BCM-SY Instructions for Use Rev G.pdf

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