Integra Cusa Excel - User Guide Manual

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Distributed By:

Integra LifeSciences Corporation

Plainsboro, NJ 08536 USA

Integra LifeSciences (Ireland) Limited

IDA Business and Technology Park

Sragh

Tullamore, County Offaly, Ireland

Printed in USA

945102217ILS

Cusa EXcel Ultrasonic Surgical Aspirator User’s Guide

USER’S GUIDE

Main Page

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

Integra Cusa Excel - User Guide Manual

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