CRYSTAL VISION Model 350-D Operating and Installation Manual Rev S Oct 2012

Table of Contents LIMITED WARRANTY: ... iv IMPORTANT SAFEGUARDS AND NOTICES ... v GENERAL WARNINGS ... vi GENERAL CAUTIONS... vi SPECIFICATIONS ... 1 WARNINGS ... 3 NOTES: ... 3 INSTALLATION/OPERATIONS INSTRUCTIONS ... 4 ESU SENSOR INSTALLATION: ... 5 LASER SENSOR INSTALLATION ... 6 CHECK PROPER OPERATION OF THE CRYSTAL VISION ... 8 DESCRIPTION OF SWITCHES, CONTROLS & INDICATORS ... 10 LAPAROSCOPIC OPERATION ... 14 NON-LAPAROSCOPIC GYNECOLOGY PROCEDURES: ... 16 OTHER NON-LAPAROSCOPIC PROCEDURES: ... 17 THEORY OF OPERATION ... 19 PNEUMATIC CIRCUITS ... 19 ELECTRONIC CIRCUITS ... 19 START PUMP: ... 19 STOP PUMP: ... 19 TIME CONTROL: ... 19 FLOW CONTROL: ... 20 HIGH (OPEN) FLOW RANGE: ... 20 LOW (LAP) FLOW RANGE ... 20 TROUBLE SHOOTING GUIDE ... 21 PREVENTIVE MAINTENANCE ... 23 CLEANING INSTRUCTIONS: ... 23 CRYSTAL VISION PARTS/ORDER INFORMATION ... 24 HOSPITAL LEVEL CALIBRATION INSTRUCTIONS ... 25

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Table of Figures Figure 1: Charcoal Output filter and power cord connections. ...5 Figure 2: ESU sensor connection to an electrosurgery unit and the Crystal VisionTM. ...5 Figure 3: Sensor assembly parts and connection to the Crystal VisionTM. ...6 Figure 4: Sensors are fastened to the SIDE of the laser foot switch HOUSING. ...6 Figure 5: Sensors should be positioned so that ANY movement of the pedal interrupts the beam. ...7 Figure 6: Power switch locations...8 Figure 7: Manual and Time Control locations. ...8 Figure 8: Flow adjustments. ...9 Figure 9: Location of power switches. ...10 Figure 10: Manual switch and sensor connectors...10 Figure 11: Adjustment for time setting. ...11 Figure 12: Setting the flow RANGE...11 Figure 13: Selecting the desired flow. ...12 Figure 14: Front Panel Indicators. ...12 Figure 15: Input Filter connectors. ...13 Figure 16: Laparoscopy set up when using the CRYSTAL VISIONTM with an electrosurgical unit and/or a laser. ..14 Figure 17: Set up for gynecology procedure for either ESU or CO2 laser delivered through a colposcope or Micromanipulator. ...16 Figure 18: Set up for using CRYSTAL VISIONTM with an ESU system during an open procedure. ...17 Figure 19: Using a CRYSTAL VISIONTM with a laser hand piece. ...17

ii

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. With respect to the Crystal VisionTM, the warranty period is one (1) year from delivery. 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. Medical, Inc. will, at its option, repair or replace the defective Product or Consumable without charge, using new or remanufactured parts. I. C. Medical, Inc. reserves the right to make a repair in its factory, at any authorized repair facility. The purchaser shall pay factory return shipping charges, if any. The warranty is null and void if the purchaser attempts to service or repair the product (other than the performance of routine maintenance as described in the Operator's Manual), or if service is performed by persons not authorized by I. C. Medical, Inc. In addition, the warranty is null and void if the Product or consumable is used other than as specified in the Operators Manual. Without limitation, the warranty does not cover damage caused by customer misuse of a Product. THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTIES EXPRESSED OR IMPLIED, AND ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS EXPRESSLY DISCLAIMED. Purchaser's exclusive remedy for any failure of any Product or Consumable is as provided in this Limited Warranty, and in no event shall I. C. Medical, Inc. be liable for any special, incidental, consequential, indirect or other similar damages arising from breach of warranty, breach of contract, negligence or any other legal theory.

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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. Warning: Any instructions in this manual that require opening the equipment cover or enclosure are for use by I. C. Medical, Inc. qualified service personnel only. To reduce the risk of electric shock, do not perform any other service than that contained in the operating instructions unless you are determined by I. C. Medical, Inc. to be qualified to do so. The exclamation point within an equilateral triangle is to alert the user/reader to the presence of important operating, warnings, and maintenance/service instructions.

The lightning flash with arrowhead symbol within an equilateral triangle alerts the user to the presence of electrical shock risks within the smoke evacuator’s enclosure. Always take precautions to protect users/qualified personnel from electrical shock risks. Indicates that the device is Class I, Type BF

The fuse symbol indicates that the fuse referenced in the text must be replaced with one having the ratings indicated. The Thermometer represents that during shipping and storage, the smoke evacuator can be left in an environment where temperatures range from -40ºC to +70ºC and pressures of 500 hPa to 1060 hPa

This symbol represents that during shipping and storage, the smoke evacuator can be left in an environment where Relative Humility can range from 10 to 100 percent.

Federal (USA) law restricts this device to sale by or on the order of a physician.

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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. To avoid electrical shock, plug the power cord into a properly wired receptacle before operating the equipment. Route power cords so they are not likely to be damaged. Disconnect power before cleaning the equipment. Do not use aerosol cleaners, use a damp cloth. Dangerous voltages may exist at several points in this equipment. To avoid injury, do not touch exposed connections and components while power is on. Do not wear rings or wristwatches when troubleshooting the equipment. To avoid fire hazard, use only specified fuse(s) with the correct type number, voltage, and current ratings as referenced on the equipment. Qualified service personnel should replace fuses. To avoid explosion, do not operate this equipment in an explosive atmosphere. Qualified service personnel should perform safety checks periodically and after any service. Keep the back of the unit away from the patient vicinity (which is commonly defined as the space within 1.8m/6 feet of the patient/operating table), or otherwise be generally inaccessible to the patient. Do not operate unit without Input Filter (ICM-000-0014; ICM-000-0434; ICM-000-0307). Do not operate machine without Output Filter (ICM-000-0025). Make sure the unit is in a safe and stable environment as to prevent falling or being dropped, which may cause damage.

GENERAL CAUTIONS A caution indicates a possible hazard to equipment that could result in equipment damage. Observe the following cautions when operating or working on this equipment.      

When installing this equipment, do not attach the power cord to building surfaces. To prevent damage to equipment when replacing fuses, locate and correct the problem that caused the fuse to blow before re-applying power. Use only specified replacement parts. Follow precautions for static sensitive devices when handling this equipment. 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.

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Crystal VisionTM Model 350-D SPECIFICATIONS INTENDED USE:

The CRYSTAL VISIONTM 350-D is intended to remove smoke created in any surgical procedure. It is especially useful during laparoscopy and thoracoscopy procedures. The Model 350-D 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. During internal surgical procedures such as laparoscopy, it helps to maintain the desired internal pressure (pneumoperitoneum). The smoke evacuator removes up to 20 liters-perminute of gases, vapors, or smoke that is produced, or introduced, by devices such as insufflators, lasers, electrosurgical generators, argon beam coagulators and other devices. The Model 350-D automatically activates when active (smoke producing) devices that are coupled to the 350-D with special sensors are turned on. The 350-D automatically turns off, at a time predetermined by the operator, after the active device turns off. The Model 350-D also automatically activates when the high pressure limit is exceeded in the pneumoperitoneum and it remains running to remove smoke, vapors, and gases until the internal pressure returns to levels below the preset maximum. The Model 350-D can also be used to evacuate CO2 gas from the pneumoperitoneum at the end of laparoscopic procedures.

PRODUCT DISPOSITION

At the end of useful life, dispose of product in accordance with your institutional protocol for capital equipment. I.C. Medical, Inc. has defined the useful life for the Crystal VisionTM as 20 years from date of manufacture.

SIZE:

7.25" H x 14.0" W x 12.0" D (18.4 cm H x 35.6 cm W x 30.5 cm D). Allow an additional 1.0" (2.5 cm) on both sides and 6.0" (15.2 cm) behind the device for the Charcoal Output Filter and adequate cooling.

WEIGHT:

Approximately 17 pounds (7.7 kg).

SHIPPING/STORAGE ENVIRONMENT

An ambient temperature range of -40ºC to +70ºC; A relative humidity range of 10% to 100%, including condensation; An atmospheric pressure range of 500 hPa to 1060 hPa.

OPERATING ENVIRONMENT

Temperature:

POWER REQUIREMENTS:

100-240 V~, single phase, 4.0 amp

LEAKAGE CURRENT:

<100 μamps, Conforms to IEC 60601-1

FUSE RATING:

4.0 Amperes 250 Volt

FLOW RATE: HIGH (OPEN) RANGE: LOW (LAP) RANGE: ACCURACY

Minimum: N/A Maximum: At least 90 Liters/Minute. Minimum: 4 (±1) lpm Maximum: (At least 18 Liters/Minute) ±10%

MAXIMUM VACUUM:

Will not be more negative than -528mmHg.

MANUAL START SWITCH:

YES

INDICATORS:

POWER ON HIGH (OPEN) FLOW ON LOW (LAP) FLOW ON OCCLUSION CHANGE FILTER NO PRESSURE OVER PRESSURE HIGH (OPEN) FLOW RATE LOW (LAP) FLOW RATE HIGH (OPEN) FLOW SET POINT LOW (LAP) FLOW SET POINT TIME SET

0o - 40o C Range of operating environment.

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Visual Indicator Visual Indicator Visual Indicator Visual & Audio Indicators Visual Indicator Visual Indicator Visual & Audio Indicators LED Meter LED Meter LED Barograph LED Barograph LED Meter

ULPA INPUT FILTER: WITH WATER TRAP:

Multiple Use: Change when CHANGE FILTER illuminates on front panel; replace cap on input connector when ULPA Input Filter with water trap not in use. 0.1 micron, ULPA rated filter 99.999954% Efficient

CHARCOAL OUTPUT FILTER:

RE-USABLE, REPLACE WHEN NOTICEABLE ODOR IS DETECTED, OR EVERY THREE MONTHS, WHICHEVER OCCURS FIRST. INITIAL REMOVAL EFFICIENCY OF 99.99% FOR THE FOLLOWING: OIL MIST, AEROSOLS, VAPORS HYDROCARBON VAPORS FAT VAPORS MOISTURE DROPLETS

INITIAL REMOVAL EFFICIENCY TO 0.5 micron FOR THE FOLLOWING: DIRT ATMOSPHERIC DUST FINE PARTICLES RUST SMOKE PARTICLES BACTERIA

THE FOLLOWING ARE REMOVED UNTIL ODORS ARE NOTICEABLE: ODORS ORGANIC SOLVENT VAPORS TRACE ORGANIC GASES TOXIC VAPORS

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WARNINGS: 

Use only under the direction of a licensed physician.



Do not exceed 27 mmHg of intraabdominal pressure. Do not use HIGH FLOW in Laparoscopic Procedure

 

Do not re-use, disposable Sterile Tubing Sets, PenEvacs, and Disposable ESU Shrouds that are SINGLE USE ONLY.



NOTES:



For best results during laparoscopic procedures, use with insufflators that deliver flow rates greater than six (6) liters/minute. For more information, see the notice on page 4.



Using the CRYSTAL VISIONTM with insufflators that deliver less than six (6) liters/minute will produce results that will not be satisfactory for most surgeons during most procedures.



Replace the Charcoal Output Filter (ICM000-0025) as soon as odors become noticeable, or every three months, whichever occurs first

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INSTALLATION/OPERATIONS INSTRUCTIONS

WARNINGS:

IMPORTANT NOTICE: During laparoscopic procedures, the CRYSTAL VISIONTM is designed to remove automatically smoke plume and water vapor from the peritoneal cavity while maintaining the pneumoperitoneal pressure that the surgeon has selected on the insufflator. Therefore, the volume of smoke that can be removed by the CRYSTAL VISIONTM is directly dependent on the flow rate of the insufflator. Insufflators that cannot deliver a flow of at least 6 Liters Per Minute will not permit results that are satisfactory for most surgeons during typical laparoscopic cases. They may be suitable for procedures that generate small amounts of plume. Insufflators that deliver flow rates of 6 Liters Per Minute will provide results that are satisfactory for most surgeons during a large majority of laparoscopic procedures. However, there may be a few occasions when very large quantities of smoke are generated over long periods and results will be marginal, or even unsatisfactory. Insufflators that deliver flow rates ABOVE 6 Liters Per Minute are recommended to be used by surgeons who frequently perform procedures that generate very large amounts of plume over extended amounts of time.

 Use only under the direction of a licensed physician.  Do not exceed 27-mmHg intraabdominal pressure.  Do not use HIGH FLOW in Laparoscopic Procedure  Do not re-use, disposable Sterile Tubing Sets, PenEvacs, and Disposable ESU Shrouds that are SINGLE USE ONLY. The CRYSTAL VISIONTM 350-D is intended to remove smoke created in any surgical procedure. It is especially useful during laparoscopy and thoracoscopy procedures. The Model 350-D 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. During internal surgical procedures such as laparoscopy, it helps to maintain the desired internal pressure (pneumoperitoneum). The smoke evacuator removes at least 18 liters-per-minute of gases, vapors, or smoke that is produced, or introduced, by devices such as insufflators, lasers, electrosurgical generators, argon beam coagulators and other devices. The Model 350-D automatically activates when active (smoke producing) devices that are coupled to the 350D with special sensors are turned on. The 350-D automatically turns off, at a time predetermined by the operator, after the active device turns off. The Model 350-D also automatically activates when the high pressure limit is exceeded in the pneumoperitoneum and it remains running to remove smoke, vapors, and gases until the internal pressure returns to levels below the preset maximum. The Model 350-D can also be used to evacuate CO2 gas from the pneumoperitoneum at the end of laparoscopic procedures.

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The following items will be needed and are available for use with your CRYSTAL VISIONTM:      

ESU Sensor Assembly (ICM-000-0009, ICM-0000009R) Laser Sensor Assembly with Cable (ICM-0000018) Hospital Grade Power Cord Charcoal Output Filter ICM-000-0025 Ulpa Filter w/water trap ICM-000-0014 and ICM000-0434 Installation and Operating Instructions Figure 1: Charcoal Output filter and power cord

Be sure that you have inspected them for any sign of damage. 1. 2. 3. 4.

connections.

Attach the Charcoal Output Filter to the connector on the back of the Crystal VisionTM. Attach the Ulpa filter w/water trap to the connector on the front of the Crystal VisionTM.. Attach the power cord to the Crystal VisionTM.. Refer to Figure 1.

ESU SENSOR INSTALLATION: If you are going to use your Crystal VisionTM.with an electrosurgical unit (ESU), proceed with the following: 1.

Plug the ESU sensor connector into the ESU connector on the Crystal VisionTM.front panel. (The Laser connector may also be used.)

2.

Hook the clip on the end of the ESU sensor over the electrical cord that is attached to the active ESU accessory (such as an ESU hand switching pencil) that is being used with the ESU generator. The sensor should be placed over the cord and as close to the ESU generator as possible.

3.

Figure 2: ESU sensor connection to an electrosurgery unit and the Crystal Vision.

The Crystal VisionTM.will now turn on any time that the accessory is activated.

5

LASER SENSOR INSTALLATION If you are going to use your Crystal VisionTM with a laser, proceed with the following: 1. Attach the Sensor Cable (Figure 3) to the LASER connector on the Crystal VisionTM and to the Sensor Connector Box. 2.

The Sensor Assembly has three parts: the Sensor Connector Box, the Transmit Sensor, and the Receive Sensor. Both Sensors have double-backed tape on one side and an infrared lens on the side opposite the tape. The Receive Sensor has a red indicator lamp that will light when the sensor assembly is plugged into the operating Crystal VisionTM. (NOTE: When the red light goes off, Crystal VisionTM will start to operate.)

LASER E.S.U.

RECEIVER

Test the Sensor Assembly for proper operation:  Plug the Sensor Cable into the Sensor Connector Box and the LASER connector of the Crystal VisionTM.  Plug the Crystal VisionTM into an AC outlet and turn on the Power Switch on the Control Box back panel and front panel.  Align the Transmit Sensor Lens and the Receive Sensor Lens until the red light goes off and the Crystal VisionTM starts.  Move the Sensor until the red light comes on. The pump in the Crystal VisionTM will stop operating sometime within 30 seconds after the light goes out. (NOTE: the actual amount of time that is required for the pump to cease operation is determined by the TIME adjustment on the Crystal VisionTM front panel). 3.

Place the foot switch for the laser on an easily accessible work surface (Figures 4 & 5).

4.

Inside the foot switch housing, position the Transmit Sensor and the Receive Sensor on opposite sides of the foot switch. Do not position the sensors on the sides of the foot switch.

SENSOR ASSEMBLY

SENSOR CABLE

TRANSMITTER

Figure 3: Sensor assembly parts and connection to the Crystal VisionTM.

WITHOUT REMOVING THE PROTECTIVE COVERING ON THE TAPE Position them so that the red light comes on.

Figure 4: Sensors are fastened to the SIDE of the laser foot switch HOUSING.

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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. THE LIGHT SHOULD GO OUT FOR THE SLIGHTEST MOVEMENT OF THE FOOT PEDAL. If it does not, move both sensors higher up the wall of the protective housing of the laser pedal. CAREFULLY MARK THE LOCATION OF BOTH SENSORS HOUSING

6.

Remove the protective backing from one Sensor and place it in the correct position on the side of the Laser Foot Switch Assembly. (NOTE: It is usually very helpful to only LIGHTLY position the sensors at first and only after you are certain that they are in the exact position press them firmly into place.)

FOOT PEDAL

BEAM

BEAM

WARNING- Repositioning either sensor after it has been firmly set in place can easily destroy it 7.

Repeat the process for the other Sensor.

8.

Move the Sensor Connector Box to a convenient location inside the Laser Foot Switch Assembly. Be sure that the cables from the Sensors to the Sensor Connector Box do not interfere with the operation of the foot switch or with the surgeon's foot. Carefully mark this location

9.

Remove the protective covering from the tape on the Sensor Connector Box and attach it to the previously marked location inside the Laser Foot Switch Assembly.

FOOT PEDAL

TRANSMITTER OR RECEIVER

(a)

(b)

Figure 5: Sensors should be positioned so that ANY movement of the pedal interrupts the beam.

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CHECK PROPER OPERATION OF THE CRYSTAL VISIONTM 1.

2.

Two switches (Figure 6) control power to the Crystal VisionTM. The main power switch is located on the back panel next to the power cord. Place this in the "ON" [I] position. Place the FRONT PANEL ON/OFF switch in the "ON" position. This switch controls the low voltage to the front panel and pump. When it is turned on the FLOW SET, indicators and the LEDs for TIME and FLOW should illuminate.

MAIN POWER SWITCH ON LOCATED ON BACK OFF

Adjust the TIME CONTROL (Figure 7) until the TIME display reads 2 SECONDS. The pump should operate when the ESU Sensor or Laser Foot Switch is activated and stops within approximately 2 seconds after the foot switch is released.

3.

The pump should operate when the MANUAL switch (Figure 7) on the Control Box front panel is depressed and stop operating within approximately 2 seconds after the switch is released.

4.

Turn the TIME CONTROL on the front panel fully clockwise. The TIME display should read 30 seconds. Press and release the MANUAL switch. The pump should start and then stop approximately thirty (30) seconds after the switch is released.

5.

Turn the TIME CONTROL fully counterclockwise. The TIME display should read 2 seconds. Press and release the MANUAL switch. The pump should start and then stop approximately 2 seconds after the switch is released.



I

0

USE ONLY WITH 250 V FUSES

FRONT PANEL ON/OFF SWITCH

ON

Figure 6: Power switch locations.

TIME CONTROL MANUAL

NOTE:

Figure 7: Manual and Time Control locations.

The FLOW CONTROL adjusts the desired flow rate on the appropriate BARGRAPH. The digital FLOW meter reads the actual flow through the Crystal Vision. The desired flow is not the same as the actual flow. The HIGH (OPEN)/LOW (LAP) switch changes the color of the FLOW and TIME displays. The displays are RED when the switch is in the HIGH (OPEN) FLOW position and are GREEN when it is in the LOW (LAP) FLOW position.

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6.

The FLOW CONTROL (Figure 8) adjusts the desired Flow level on the FLOW SET BARGRAPHS. The HIGH (OPEN) or LOW (LAP) bargraph is used depending on which Flow rate (HIGH (OPEN) or LOW (LAP) is selected by the HIGH (OPEN)/LOW (LAP) SELECTOR SWITCH. The digital meter above the FLOW CONTROL adjustment indicates the actual Flow through the unit. Some RF noise may cause the flow display to flicker, however it will not affect the actual flow or the functionality of the Crystal VisionTM.

7.

Place the HIGH (OPEN)/LOW (LAP) FLOW switch (Figure 8) to the HIGH (OPEN) FLOW position. Set the FLOW ADJUSTMENT control so that the HIGH (OPEN) FLOW BARGRAPH reads maximum. Press the MANUAL switch. The FLOW meter LEDs should read at least 90 litersper-minute.

8.

Figure 8: Flow adjustments.

9.

Turn the HIGH (OPEN)/LOW (LAP) FLOW switch to the LOW (LAP) FLOW position. Set the FLOW ADJUSTMENT control for minimum on the LOW (LAP) FLOW BARGRAPH. Press the MANUAL switch. The FLOW meter should read 4 (±1) lpm. Repeat the process for maximum Flow. The meter should read at least 18 liters-per-minute.

Place a finger over the ULPA Input Filter with water trap input and press the MANUAL switch. The CHANGE FILTER and OCCLUSION lamps should light. The OVER PRESSURE indicator requires special test equipment and should be tested only by trained qualified personnel.

10. If you have problems, or the CRYSTAL VISIONTM fails to perform as indicated, contact I. C. Medical, Inc. at (623) 780-0700.

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DESCRIPTION OF SWITCHES, CONTROLS & INDICATORS The Sensor Assembly and the Charcoal Output Filter should already be installed according to the INSTALLATION INSTRUCTIONS. 1.

2.

3.

MAIN POWER SWITCH ON LOCATED ON BACK OFF

MAIN POWER SWITCH is located on the back panel (Figure 9) next to the power cord. This switch controls the primary power to the Crystal VisionTM. International symbols are used. The [I] symbol indicates power "ON" and [O] indicates "OFF." This switch also controls the cooling fan.

5.

ESU CONNECTOR (Figure 10) is the input for the ESU SENSOR CABLE. This sensor can be used with a variety of devices to control the start and stop time of the CRYSTAL VISIONTM.

ON

Figure 9: Location of power switches.

MANUAL switch (Figure 10) is used to turn the CRYSTAL VISIONTM on when the surgeon is not activating a smoke-producing device. This is particularly helpful when insufflators are used that deliver 6 liters-perminute or less. The MANUAL control can be used to clear residual plume during these situations of LOW (LAP) flow. It can also be used to clear smoke and plume if more than one device is used and only one sensor is available. This frequently occurs during laser cases when a sensor is attached to the laser foot pedal and other sensors are not available to be attached to an Electrosurgical Unit (ESU). LASER CONNECTOR (Figure 10) is the input for the LASER SENSOR CABLE. In reality, both LASER & ESU connectors are identical and either will accept all standard I.C.Medical sensor assemblies.

USE ONLY WITH 250 V FUSES

FRONT PANEL ON/OFF SWITCH

FRONT PANEL ON/OFF SWITCH is located on the front panel (Figure 9). This switch controls all of the low voltage for the system. This switch controls the pump, Front panel lights, and meters.

4.

I 0

LASER

Figure 10: Manual switch and sensor connectors.

10

E.S.U.

6.

TIME ADJUST (Figure 11) varies the amount of time that the Crystal VisionTM continues to draw smoke, vapor, and gases from the surgical site. Many insufflators deliver CO2 at rates less than 6 liters-per-minute. These low flows into the pneumoperitoneum limit the amount of gas that can be evacuated from the pneumoperitoneum without causing the abdomen to deflate. In cases such as this, it is very useful to limit the flow rate to a value that can be supplied by the insufflator. To extend the amount of time that the Crystal VisionTM operates after the foot pedal (or hand switch) is released. This allows for a greater volume of gas to be eliminated from the abdomen and therefore reduces the amount of residual smoke that is left in the abdomen. The ideal situation is to increase the amount of flow into the abdomen. See the highlighted box titled "FOR BEST RESULTS" in the LAPAROSCOPIC OPERATION section that follows.

7.

TIME DISPLAY (METER) (Figure 11) indicates the amount of time that the Crystal VisionTM will operate after the foot switch, or hand switch, is deactivated

8.

HIGH (OPEN)/LOW (LAP) FLOW SWITCH (Figure 12) selects the flow range of the vacuum pump. The operator, according to the type of procedure selects the range. LOW (LAP) FLOW IS SELECTED FOR ALL LAPAROSCOPIC PROCEDURES and the readouts are GREEN. HIGH (OPEN) Flow is used during open and external cases when plume is being eliminated through a handpiece. Using HIGH (OPEN) FLOW during laparoscopy will quickly deflate the pneumoperitoneum. The HIGH (OPEN)/LOW (LAP) FLOW SWITCH also selects the corresponding FLOW SET BARGRAPH.

9.

Only one of the bargraph (Figure 13) is illuminated at a time. This eliminates confusion regarding which graph to read. It is very important to remember that these bargraph display the FLOW SET value. This will show the amount of Flow that is DESIRED by the surgeon.

Figure 11: Adjustment for time setting.

Figure 12: Setting the flow RANGE.

11

10.

FLOW SET ADJUSTMENT (Figure 13) sets the maximum flow that is desired by the surgeon. This value is displayed on the bar graph for the selected flow range. The value registering on the digital meter above this control is actual amount of flow at the current time.

11.

FLOW METER (Figure 13) reads the amount of gas and vapor that is actually flowing at the present time. This value should be zero, when the vacuum pump is not turned on. The FLOW METER is not adjusted by the FLOW SET ADJUSTMENT that is located just below the meter.

12.

CHANGE FILTER indicator is red (Figure 14). It illuminates when there is a reduced flow into the Crystal VisionTM. The ULPA Input Filter with water trap should be changed when this light first illuminates. Do not attempt to clean, or re-use the ULPA Input Filter with water trap. Dispose of the ULPA Input Filter with water trap according to your institution's biological waste protocol. This indicator will also come on when there is a total occlusion. If the OCCLUSION indicator is also lit, be sure to clear the obstruction that caused it first and then check the CHANGE FILTER indicator. If it is still illuminated and the OCCLUSION indicator is not, then the ULPA Input Filter with water trap needs to be changed.

13.

OCCLUSION indicates that flow into the Crystal VisionTM has stopped (Figure 14). The CHANGE FILTER light will also come on at this time. The operator should check for kinked tubing, stopcocks that are turned off, clogged insufflator output filters, or a completely clogged ULPA Input Filter with water trap. In order to prevent destruction of the pump, the Crystal VisionTM pump will not activate when this lamp is illuminated.

Figure 13: Selecting the desired flow.

Figure 14: Front Panel Indicators.

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14.

OVER PRESSURE indicates pressure exceeding 27 mmHg in the pneumoperitoneum (Figure 14). This condition causes the vacuum pump to start in order to reduce the pressure in the pneumoperitoneum. At pressures over 30 mmHg, a pressure relief valve opens. This situation can be caused by many factors. Frequently, the surgeon presses on the abdomen and this causes intra-abdominal pressure to rise. Correct the cause before continuing.

15.

The "NO PATIENT" indicator (Figure 14) turns on when the Crystal VisionTM is in the LOW (LAP) RANGE selection, when zero pressure, or atmospheric pressure, is present at the ULPA Input Filter with water trap. The tubing set may not be connected to the Trocar sheath or to the ULPA Input Filter with water trap; the valve on the Trocar sheath may be turned off; or the ULPA Input Filter with water trap may not be attached to the input filter connector.

16.

INPUT FILTER CONNECTOR (Figure 15) holds the ULPA Input Filter with water trap. The metal ring is pushed down to allow the ULPA Input Filter with water trap to be released. Replace cap on end of ULPA Input Filter with water trap between uses. Change ULPA Input Filter with water trap when CHANGE FILTER indicator illuminates. Charcoal OUTPUT FILTER CONNECTOR is not shown. It is located on the back panel of the Crystal VisionTM. The Charcoal Output filter- is reusable for several cases. The Charcoal Output filter has a functional life of three to four months depending on usage. Sometimes, it will require changing sooner. The Charcoal Output filter provides odor control. It also reduces vacuum pump noise. Do not operate the unit without a Charcoal Output filter.

17.

Figure 15: Input Filter connectors.

13

LAPAROSCOPIC OPERATION FOR BEST RESULTS:   



Use with insufflators that deliver more than 6 liter per minute. Insufflators that deliver only 6 liters per minute will provide satisfactory results during most procedures. Insufflators that provide less than 6 liters per minute will not provide satisfactory results in most cases. Read “Important Notice” on page 1 for more information.

6.

Plug Crystal VisionTM into power outlet.

7.

Insufflator should already be connected to the port on the laparoscope. IT SHOULD NEVER BE CONNECTED TO THE TROCAR SHEATH. Insufflator should be set for a flow of AT LEAST 6 LITERS-PER-MINUTE as directed by the surgeon. Connect Sterile Intra-Abdominal Plume Eliminator Tubing (ICM-000-0003)* to Trocar sheath and ULPA Input Filter with water trap assembly. NEVER connect the Crystal VisionTM to the laparoscope port. *ICM-000-0448 Non-sterile Intra-Abdominal Plume Eliminator Tubing Set is available.

8.

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 16.

4.

Connect ULPA Input Filter with water trap.

10. Set HIGH (OPEN)/LOW (LAP) FLOW SWITCH to LOW (LAP) FLOW

5.

Connect sensor cable from the LASER SENSOR and/or the ESU SENSOR, as desired, to the Crystal VisionTM front panel.

11. Set the TIME (maximum).

9.

Turn on MAIN POWER SWITCH on back of CRYSTAL VISION and be sure front panel ON SWITCH is turned on.

C I. C. MEDICAL, INC

.

CONTROL fully clockwise

Crystal Vision 350D - 16

FLOW 88

- 13

L/MIN

FLOW SET LOW MAXHIGH - 20 -

TIME 88

MANUAL

SEC

HIGH

FILTER

-

- 11 - 10

-

CRYSTAL VISION EBS ICM-350D

-9 -8

WARNING! FILTER & TUBING STERILIZE, OR RE-USE.

LOW

-7 MIN

-

-6 -4

LASER OCCLUSION CHANGE FILTER OVER PRESSURE NO PATIENT

ESU I/O

Remote Activation Device

Figure 16: Laparoscopy set up when using the Crystal VisionTM with an electrosurgical unit and/or a laser.

14