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14-6 CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Integra Service Center

Integra LifeSciences

Plainsboro, NJ, 08536

USA

Ph: 303-530-2300

Toll Free: 800-654-2873

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00 CUSA UG.I+D2
- User’s Guide2
- CUSAEXcel™ Ultrasonic Surgical Aspirator System2
- CUSAEXcel™ Ultrasonic Surgical Aspirator System User’s Guide3
- Preface4
00 CUSA UG.I+DLOF8
- List of Figures8
00 CUSA UG.I+DTOC10
- Table of Contents10
01 CUSA UG.I+D19
- Patient and Operating Room Safety19
- Indications for Use19
  - The CUSA EXcel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures w...19
- Safety Information19
  - The safe and effective use of ultrasonic surgery depends to a large degree on factors solely unde...19
  - Physicians have used ultrasonic equipment safely in numerous procedures. Before starting any surg...19
- Warnings, Cautions, and Notices20
  - To promote the safe use of the CUSAEXcel ultrasonic surgical aspirator, this section presents th...20
01 Part 1 CUSA UG.I+D18
- Safety18
02 CUSA UG.I+D27
- Introduction to the Console27
03 CUSA UG.I+D33
- Console Components33
- For Your Information33
- Console Overview and Structural Features34
- Control Panel36
- Console Body – Front Panel40
- Console Body – Side Panel42
- Console Body – Rear Panel44
- Symbols on the Control Panel48
04 CUSA UG.I+D49
- Using CUSAEXcel ConsoleControls49
05 CUSA UG.I+D67
- Setting Up the CUSAEXcel System67
06 CUSA UG.I+D84
- Shutting Down theCUSAEXcelSystem84
07 CUSA UG.I+D91
- Introduction to Handpieces91
- For Your Information91
- Description92
- Functions92
- Configurations93
- Wide Variety of Tips93
08 CUSA UG.I+D95
- Handpiece Components95
09 CUSA UG.I+D105
- Assembling the Handpiece inaNonsterile Area105
10 CUSA UG.I+D115
- Sterilizing Handpieces and Accessories115
11 CUSA UG.I+D119
- Completing Handpiece Setup ontheSterile Field119
12 CUSA UG.I+D128
- Disassembling Handpieces128
13 CUSA UG.I+D135
- Troubleshooting theCUSAEXcelSystem135
13 Part 4 CUSA UG.I+D134
- Troubleshooting and Maintenance134
14 CUSA UG.I+D150
- Maintaining theCUSAEXcelSystem150
1A CUSA UG.I+D156
- Technical Specifications156
  - Console Dimensions156
    - CUSAEXcel Console156
- Height156
- 1.32 m (52 in.)156
- Width156
- 55.88cm (22 in.)156
- Depth156
- 71.12cm (28 in.)156
- Weight156
- 95.3kg (210 lb.)156
  - Footswitch156
- Height156
- 5.08cm (2 in.)156
- Width156
- 30.48cm (12 in.)156
- Cable length156
- 4.575m (15 ft)156
  - Console Subsystems157
    - Ultrasonic157
- Nominal Frequency157
- 23kHz157
- 35.75kHz157
- Maximum Tip Amplitude (23kHz)157
- Up to 355microns for straight handpiece157
- Up to 183microns for angled handpiece157
- Maximum Tip Amplitude (36kHz)157
- Up to 210microns157
  - Fluidic System157
- Cooling System157
- Cooling water flow is 35 – 50cc/min.157
- Irrigation Rate157
- The irrigation rate display shows digits 1 – 10157
- The irrigation rate is approximately 1 – 10cc/min., normal; 25–30cc/min., Fast Flush157
- Suction System157
- Up to 660mm (26 inches) mercury at the pump intake at sea level157
- The suction level will be lower at higher altitudes.157
  - Electrical Requirements158
    - Input Power Source158
- Power Ratings158
- The CUSAEXcel system operates on one of the following voltage ranges:158
- 95 - 120 Volt158
- 220 - 240 Volt158
- Frequencies158
- 60 Hz ± 2 Hz158
- 50 Hz ± 2 Hz158
- Line fusing resides in fuse receptacles on the rear panel. The fuse values for 95–120volt operat...158
  - Power Cords158
- Cord158
- UL listed 3-conductor158
- Connector158
- Hospital grade, three-prong, 95-120Van connector158
- If a facility intends to use the CUSAEXcel system in an operating room with another type of rece...158
  - Low Frequency Leakage158
- Enclosure leakage current158
- <300µA158
- Patient leakage current158
- <100µA158
  - Duty Cycle158
- Under maximum loading conditions, the CUSAEXcel console is suitable for ultrasonics activation t...158
  - Environment159
- Operating temperature range159
- 10°C (50°F) to 40°C (104°F)159
- Operating humidity range159
- 15 to 80%, relative humidity, non-condensing159
- Operating atmospheric pressure range159
- 70 CPA to 106 CPA (10.15 to 15.38 psi)159
- Storage and shipping temperature159
- -34°C (-29°F) to 65°C (149°F)159
- Storage and shipping humidity159
- 25 to 85% relative humidity, non-condensing159
- The system requires a minimum of one hour exposure at its operating temperature range before you ...159
  - Standards and IEC Classifications159
- ATTENTION Consult accompanying documents.159
- DANGER Explosion risk if used with flammable anesthetics.159
- EQUIPOTENTIAL GROUND Connect equipotential ground cable here.159
- POWER ON Applies power at the AC Main Switch and the System Power Switch.159
- POWER OFF Removes power at the AC Main Switch.159
- Protective earth ground159
- CAUTION To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualifi...159
- Classified with respect to electrical shock, fire, mechanical, and other specified hazards only i...159
  - Class I Equipment (IEC 601-1)160
- Accessible conductive parts cannot become live in the event of a basic insulation failure because...160
  - Type BF Applied Part Equipment (IEC 601-1)160
- The CUSAEXcel console provides a high degree of protection against electric shock, particularly ...160
  - IPX - 8 (IEC 529, UL60601) Footswitch160
- The CUSAEXcel footswitch includes protection against the effects of continuous immersion in water.160
  - Electromagnetic Interference160
- The CUSAEXcel console minimizes electromagnetic interference to other equipment used in the oper...160
- Note that other devices in the operating room may generate electromagnetic interference. Use caut...160
  - System Power Off / Standby160
- When you turn off the System Power Switch, the system automatically drains water from the cooling...160
  - Pinch Point in the Suction Pinch Valve160
- The suction pinch valve may pose a hazard during normal use.160
  - Fuse Replacement160
- Indicates the location of the fuse drawer on the rear panel.160
  - Footswitch Symbols161
- The following symbols appear on the CUSAEXcel footswitch:161
- Activate vibration.161
- Activate fast flush (irrigation).161
  - Voluntary Standards161
- The CUSAEXcel system meets the following standards:161
  - EMC Compatibility161
  - Handpieces162
    - Nominal Frequencies162
- 23kHz Straight162
- 23kHz162
- 23kHz Angled162
- 23kHz162
- 36kHz Straight162
- 35.75kHz162
  - Dimensions162
- Length162
- 22.2cm (8.74 in.)162
- Diameter162
- 20.8mm (0.82 in.)162
- Length162
- 22.2cm (8.74 in.)162
- Diameter162
- 20.8mm (0.82 in.)162
- Length162
- 13.9cm (5.47 in.)162
- Diameter162
- 16.4mm (0.65 in.)162
  - Tip Specifications162
- The table on pages A8 shows specifications for tips that attach to the 23kHz handpiece.162
- The table on pages A9 shows specifications for tips that attach to the 36kHz handpiece.162
  - 23kHz163
  - Table A-1. Tip Specifications—23kHz163
    - 36kHz164
  - Table A-2. Tip Specifications—36kHz164
1A Part 5 CUSA UG.I+D166
- Appendix166
1B CUSA UG.I+D168
- Warranty168
1S CUSA UG Sup.I+D172
- Assembling or Changing Tipsonthe Sterile Field172

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