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I. C. MEDICAL, INC.
®
CRYSTAL VISION
Model 450D
REF
ICM-450-0000
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-450-9000 Rev. N Date: 2021-03
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Summary of Contents for IC Medical CRYSTAL VISION 450D
- Page 1 I. C. MEDICAL, INC. ® CRYSTAL VISION Model 450D ICM-450-0000 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.
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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 ... - Page 3 Table of Figures Figure 1: Filters and Power Cord Installation ........................4 Figure 2: ESU and RF Sensor installation when used with an electrosurgical generator (ESU) ........5 Figure 3: UNIVERSAL BLUE RF Sensor installation when used with an electrosurgical generator (ESU) ....6 ...
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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
IMPORTANT SAFEGUARDS AND NOTICES The following pages provide important guidelines for operators and service personnel. Specific warnings and cautions appear throughout the manual where they apply. Please read and follow this important information, especially those instructions related to risk of electric shock or injury to patient or staff members. Any instructions in this manual that require opening the equipment cover or enclosure are for use by I.C. -
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. 8. 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
® Crystal Vision Model 450D SPECIFICATIONS INDICATION FOR USE: The CRYSTAL VISION® 450D is intended to remove smoke created in surgical procedure. USED FOR: ® The CRYSTAL VISION 450D is intended to remove smoke created in surgical procedure. The Model 450D can be used to remove smoke produced by lasers, electrosurgical devices, argon beam coagulators, LEEP devices, and other devices that create smoke during surgical procedures. - Page 9 SAFEGUARD BLUE ® Multiple Use: Change when CHANGE FILTER illuminates on front panel; replace cap on ® BLUE HYDROPHOBIC ULPA FILTER input connector when SAFEGUARD Hydrophobic ULPA Filter with Built-in Fluid Trap not in use. WITH BUILT-IN FLUID TRAP: Filtration Efficiency: Mode Particles at: (in microns) 0.03...
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Page 10: Installation/Operations Instructions
INSTALLATION/OPERATIONS INSTRUCTIONS During laparoscopic procedures, the CRYSTAL 1. Use only under the direction of a licensed ® VISION is designed to remove automatically physician. smoke plume and water vapor from the peritoneal 2. Do not exceed 27-mmHg intra-abdominal cavity while maintaining the pneumoperitoneal pressure. -
Page 11: Filters And Power Cord Installation
The following I.C. Medical’s accessories are compatible, and need to be use with your CRYSTAL VISION ® , be sure to inspect them for any sign of damage: 1. ESU Sensor 2. RF Sensor, Shielded 3. UNIVERSAL BLUE™ RF Sensor 4. -
Page 12: 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 ®... -
Page 13: 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 14: 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 15: 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 16: 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 HOUSING not, reposition the Sensors until the red light goes out when the Laser Foot Pedal is depressed and it remains on when FOOT PEDAL the pedal is not depressed. -
Page 17: 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 18: Figure 11: Flow 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 ®... -
Page 19: 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 20: Figure 14: Adjustment For Time Setting
5. TIME SETTING Buttons (Up and Down arrows) (Figure 14) varies the amount of time that the CRYSTAL VISION ® continues to draw smoke, vapor, and gases from the surgical site. The low flows into the pneumoperitoneum limit the amount of gas that can be evacuated from the pneumoperitoneum without causing the abdomen to deflate. -
Page 21: Figure 16: Selecting The Desired Flow
8. FLOW SETTING control buttons (Figure 16) sets the maximum flow that is desired by the surgeon. This value is indicated on the FLOW SETTING display. 9. FLOW READING (Figure 16) is registering the amount of gas and vapor that is actually flowing at the present time. -
Page 22: Large Coconut Charcoal Output Filter
14. INPUT FILTER CONNECTOR (Figure 18) 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®... -
Page 23: Laparoscopic Operation
LAPAROSCOPIC OPERATION Filter with Built-in Fluid Trap, filtered, and no bacteria and viruses will escape in OR. FOR BEST RESULTS: 1. Installation of Crystal Vision should already be completed according to the installation instructions. Connect SAFEGUARD BLUE ® Hydrophobic ULPA Filter with Built-in Fluid Trap to CRYSTAL VISION ®... - Page 24 Set the FLOW SETTING for a flow slightly LESS than the 5. OCCLUSION indicator lights when flow virtually ceases flow that the insufflator can provide. from the pneumoperitoneum. Check for kinked tubing, Push the MANUAL button. closed Luer lock on the Trocar sheath, severely clogged ®...
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Page 25: Non-Laparoscopic Gynecology Procedures
NON-LAPAROSCOPIC 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, Control Buttons, and Indicators. 3. Refer to Figure 21 for set-up. ® 4. Connect SAFEGUARD BLUE Hydrophobic ULPA Filter with Built-in Fluid Trap to the CRYSTAL VISION... -
Page 26: Other Non-Laparoscopic Procedures
OTHER NON-LAPAROSCOPIC 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, Control Buttons, and Indicators. 3. Refer to Figure 22 or 23 for set-up. 4. - Page 27 ® PENEVAC1 , NON-TELESCOPIC PenEvac and OTHER ACCESSORIES USED WITH CRYSTAL VISION: PenEvac Accessories: PenEvac ® accessories (PenEvac1 and Non-telescopic PenEvac) may also be used with the CRYSTAL VISION ® Model 450D. The PenEvac1 ® combines the function of an ESU pencil and smoke evacuator into a single hand-held ®...
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Page 28: Theory Of Operation
because increasing the flow rate would deflate the THEORY OF OPERATION pneumoperitoneal pressure. Instead, the flow TIME can The CRYSTAL VISION ® Model 450D was designed to be set to 30 seconds and if additional purging is required, effectively remove smoke during surgical procedures and to the MANUAL button will continue the evacuation. -
Page 29: Flow Setting
FLOW SETTING: LAP MODE: The FLOW SETTING control buttons vary the speed of the vacuum pump depending on the flow range in use. LAP flow range is used during laparoscopic (“closed”) OPEN Mode flow is adjustable to at least 90 lpm and LAP procedures, they are characterized by a limited amount of Mode flow from 4 + 1 to at least 18 lpm. -
Page 30: Trouble Shooting Guide
TROUBLE SHOOTING GUIDE SYMPTOM PROBLEM/RESOLUTION: Be sure power cord is plugged in. CRYSTAL 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, Won't Turn ON remove fuse holder, replace fuse with F4AH 250V fuse;... - Page 31 SYMPTOM PROBLEM/RESOLUTION: Airflow through the SAFEGUARD BLUE ® Hydrophobic ULPA Filter with Built-in Fluid Trap is being CHANGE FILTER reduced. Indicator Is ON This may indicate a partial obstruction for the following reasons depending upon the procedure, speculum port, partially obstructed smoke collection nozzle, or smoke tubing. Check and clean them, if necessary. ®...
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Page 32: 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 33: 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 34 OVER PRESSURE Threshold to Start Pump: 1. Set up unit according to SETUP FOR SECTION 3. 2. In the LAP MODE: set the flow at minimum, activate Test: the pump with the Manual push button. 1. Set up unit according to SETUP FOR SECTION 2. 3.
- Page 35 The CHANGE FILTER light should always come before OCCLUSION LAMP. 4. Repeat for medium and maximum flows in the OPEN MODE. Adjustment: Only make adjustments when necessary. 1. Set up unit according to SETUP FOR SECTION 4. 2. Activate the unit. 3.
- Page 36 Declaration for Electromagnetic Immunity ® ® CRYSTAL VISION Model 450D is intended for use in the electromagnetic environment specified below. The user of the CRYSTAL VISION Model 450D should assure that the CRYSTAL VISION ® Model 450D is used in such environment. IEC 60601-1-2 Requirements: Compliance Immunity Test...
- Page 37 ® ® CRYSTAL VISION Model 450D is intended for use in the electromagnetic environment specified below. The user of the CRYSTAL VISION Model 450D should assure that the CRYSTAL VISION ® Model 450D is used in such environment. IEC 60601-1-2 Requirements: Emissions test Compliance Electromagnetic environment - guidance...