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I. C. MEDICAL, INC.
Model 460
REF
ICM-460-0000
OPERATING AND INSTALLATION MANUAL
I. C. Medical, Inc.
15002 North 25th Drive
Phoenix, Arizona 85023 USA
Tel: +1(623) 780-0700 (USA)
Fax: +1(623) 780-0887 (USA)
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Made in USA
Copyright 1996-2020. All rights reserved.
Document#: ICM-460-9000 Rev: K Date: 2021-03
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Table of Contents
Summary of Contents for ICMedical 460
- Page 1 I. C. Medical, Inc. 15002 North 25th Drive Phoenix, Arizona 85023 USA Tel: +1(623) 780-0700 (USA) Fax: +1(623) 780-0887 (USA) MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Made in USA Copyright 1996-2020. All rights reserved. Document#: ICM-460-9000 Rev: K Date: 2021-03...
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Page 2: Table Of Contents
Table of Contents LIMITED WARRANTY: ............................III IMPORTANT SAFEGUARDS AND NOTICES ....................IV SERIOUS ADVERSE EVENTS ..........................IV GENERAL WARNINGS ............................V CONTRAINDICATIONS ............................V GENERAL CAUTIONS ............................V COMPATIBILITY ..............................VI SPECIFICATIONS ..............................1 INSTALLATION/OPERATIONS INSTRUCTIONS ....................3 FILTERS POWER CORD INSTALLATION: .................... - Page 3 Table of Figures Figure 1: Filters and Power Cord Installation ......................... 3 Figure 2: ESU and RF Sensor installation when used with an electrosurgical generator (ESU) ........4 Figure 3: UNIVERSAL BLUE RF Sensor installation when used with an electrosurgical generator (ESU)....5 Figure 4: UNIVERSAL BLUE RF Sensor installation when used with Harmonic Scalpel generator ......
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Page 4: Limited Warranty
LIMITED WARRANTY: For the periods and the conditions specified below, I.C. Medical, Inc. warrants to the original purchaser that I.C. Medical, Inc.’s products will perform to our published specifications when used and maintained in accordance with our written instructions. If due to a defect in materials or workmanship a Product fails to perform to our published specification, or if a Consumable is not free from defects in materials and workmanship when shipped from our factory, I.C. -
Page 5: Important Safeguards And Notices
Any serious adverse event or incident that occurs in relation to the device or accessory should be reported to the manufacturer, I.C. Medical, Inc., at complaints@icmedical.com and to the FDA. In addition, European customers should also report to the Authorized Representative at the address listed on the label... -
Page 6: General Warnings
GENERAL WARNINGS A warning indicates a possible hazard to personnel, which may cause injury. Observe the following general warnings when using or working on this equipment: Heed all warnings on the unit and in the operating instructions. Do not use this equipment in or near water. This equipment is grounded through the grounding conductor of the power cord. -
Page 7: Compatibility
This product should only be powered as described in the manual. To prevent equipment damage, select the proper voltage outlet. To prevent damage to the equipment, read the instructions in the equipment manual for proper input voltage. Keep unit at operating environment for at least 6(six) hours before use, if unit was exposed to extreme shipping and storage conditions. -
Page 8: Specifications
The Model 460 automatically activates when active (smoke producing) devices that are coupled to the Model 460 with special sensors are turned on. The Model 460 automatically turns off, at a time predetermined by the operator, after the active device turns off. - Page 9 OPEN Efficiency (%) >99.9999 >99.9999 >99.9999 LARGE COCONUT Re-usable: Change when noticeable odor is detected, or every three months, CHARCOAL OUTPUT whichever occurs first. FILTER: TURN OFF THE UNIT WHEN REPLACING THE FILTER. Filtration Efficiency: Mode Particles at: (in microns) 0.03 0.12 OPEN...
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Page 10: Installation/Operations Instructions
SINGLE USE ONLY. The CRYSTAL VISION ® Model 460 is intended to remove smoke created in any surgical procedure. The Model 460 can be used to remove smoke produced by lasers, electrosurgical devices, and other devices that create smoke during surgical procedures. -
Page 11: Esu, Rf, Or Universal Sensor Installation
ESU, RF, or UNIVERSAL SENSOR INSTALLATION: If you are going to use your CRYSTAL VISION® with an electrosurgical unit (ESU) monopolar or bipolar, ultrasonic device, harmonic scalpel, proceed with the following: RF SENSOR For use with all Crystal Vision® Models. INSTALLATION/OPERATION: RF Sensor when used with Monopolar Devices (Figure 2;... -
Page 12: Figure 3: Universal Blue Rf Sensor Installation When Used With An Electrosurgical Generator (Esu)
When not in use, put away the RF Sensor by attaching the Velcro side of the RF Sensor to the smoke evacuator. Perform first-time installation by peeling the back film from the Velcro loop tape, pressing it firmly to a clean and dry area on the side of the Smoke Evacuator. -
Page 13: Foot Switch Installation/Operation
UNIVERSAL BLUE™ RF Sensor when used with Harmonic Scalpel Generator (Figure 4; Placement 1 or 2): Plug the UNIVERSAL BLUE™ RF Sensor’s connector into Crystal Vision Smoke Evacuator’s ESU/Laser port. Place the UNIVERSAL BLUE™ RF Sensor on the hand piece cable, making sure the sensor is installed on top of the cable, facing down, to prevent capture of residual RF signal from surrounding devices. -
Page 14: Laser Sensor Installation
LASER SENSOR INSTALLATION If you are going to use your CRYSTAL VISION® with a laser, proceed with the following: 1. Attach the Sensor Cable (Figure 6) to the LASER connector on the CRYSTAL VISION ® and to the Sensor Connector Box. 2. -
Page 15: Figure 8: Sensors Should Be Positioned So That Any Movement Of The Pedal Interrupts The Beam
5. Keep the Sensors in the same position and press the Laser Foot Pedal down. The red light should go out. If it does not, reposition the Sensors until the red light goes out when the Laser Foot Pedal is depressed and it remains on when the pedal is not depressed. -
Page 16: Check Proper Operation Of The Crystal Vision
CHECK PROPER OPERATION OF THE CRYSTAL VISION ® 1. The CRYSTAL VISION ® . power switch (Figure 9) is located on the back panel, next to the power cord. Place this in the "ON" [I] position. When unit is turned ON, the FLOW SET, indicators and display for TIME and FLOW should illuminate. -
Page 17: Figure 11: Flow Adjustment Buttons
6. The FLOW SETTING buttons (Up and Down arrows), (Figure 11), adjusts the desired Flow level on the Flow Setting display. The Flow Reading digital meter indicates the actual Flow through the unit. Some RF noise may cause the Flow Set and Flow Reading to flicker; however, it will not affect the actual flow or the functionality of the CRYSTAL VISION ®... -
Page 18: Description Of Switches, Control Buttons & Indicators
DESCRIPTION OF SWITCHES, CONTROL BUTTONS & INDICATORS The Sensor Assembly and the Large Coconut Charcoal Output Filter should already be installed according to the INSTALLATION INSTRUCTIONS. 1. ON/OFF SWITCH is located on the back panel (Figure 12) next to the power cord. This switch controls the power to the CRYSTAL VISION ®... -
Page 19: Figure 15: Selecting The Desired Flow
6. FLOW SETTING control buttons (Figure 15) sets the maximum flow that is desired by the surgeon. This value is indicated on the FLOW SETTING display. 7. FLOW READING (Figure 15) is registering the amount of gas and vapor that is actually flowing at the present time. - Page 20 10. INPUT FILTER CONNECTOR (Figure 16) holds the SAFEGUARD BLUE Hydrophobic ULPA ® Filter with Built-in Fluid Trap. The metal ring is pushed down to allow the SAFEGUARD BLUE ® Hydrophobic ULPA Filter with Built-in Fluid Trap to be released. Replace cap on end of SAFEGUARD BLUE ®...
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Page 21: Operating Procedures
OPERATING PROCEDURES 1. Installation should already be completed according to the installation instructions. 2. Be familiar with all operating controls as described in description of switches, controls, and indicators. 3. Refer to Figure 18 or 19 for set-up. 4. Connect SAFEGUARD BLUE ®... - Page 22 Smoke Tubing: Smoke Tubing Accessories are intended to evacuate smoke plume produced during surgical procedures. Please refer to http://www.icmedical.com for further information. For a complete list of compatible finish product reference number, please contact I.C. Medical, Inc. CAUTIONS:...
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Page 23: Gynecology Procedures
GYNECOLOGY PROCEDURES: 1. Installation should already be completed according to the installation instructions. 2. Be familiar with all operating controls as described in description of switches, controls, and indicators. 3. Refer to Figure 20 for set-up. 4. Connect SAFEGUARD BLUE ®... -
Page 24: Troubleshooting Guide
TROUBLESHOOTING GUIDE SYMPTOM PROBLEM/RESOLUTION: CRYSTAL Be sure power cord is plugged in. Check power switch on back panel to see if it is turned on. VISION ® Blown Fuse. (Have technically qualified personnel replace as follows: Remove fuse cover with small screw driver, remove fuse holder, replace fuse with F4AH 250V fuse;... -
Page 25: Preventive Maintenance
PREVENTIVE MAINTENANCE has minimal routine preventive maintenance and calibration requirements. CRYSTAL VISION ® EVERY SIX MONTHS: Perform standard electrical leakage tests. Perform "Check Proper Operation of the Crystal Vision" as directed in a previous section. Perform "Hospital Level Calibration" only if the flow does not meet the specifications. The service personnel should be properly trained and have the correct test equipment. -
Page 26: Hospital Level Calibration Instructions
HOSPITAL LEVEL CALIBRATION INSTRUCTIONS Fully trained and knowledgeable individuals must only accomplish the following procedures with extensive experience in calibrating surgical and life support electromechanical devices. They should be aware of the importance of medical devices in the operating room environment, and physiological parameters of the patient during surgery. - Page 27 Declaration for Electromagnetic Immunity CRYSTAL VISION ® Model 460 is intended for use in the electromagnetic environment specified below. The user of the CRYSTAL VISION ® Model 460 should assure that the CRYSTAL VISION Model 460 is used in such environment.
- Page 28 CRYSTAL VISION ® Model 460 is intended for use in the electromagnetic environment specified below. The user of the CRYSTAL VISION ® Model 460 should assure that the CRYSTAL VISION ® Model 460 is used in such environment. IEC 60601-1-2 Requirements:...