Revision Rev S

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I. C. MEDICAL, INC.

CRYSTAL VISION 

Model 350-D

REF

ICM-470-0000

OPERATING AND INSTALLATION MANUAL

I. C. Medical, Inc.

2340 W. Shangri La Road

Phoenix, Arizona 85029 USA

Phone: +1(623) 780-0700 (USA)

Fax: +1(623) 780-0887 (USA)

Made in USA,

Copyright 1996-2005. All rights reserved.

Label: ICM-470-9004 Rev: S Date: 10-2012

Page 3

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

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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.

1

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

Page 8

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.

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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.

Page 17

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

Page 18

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.

12

Page 19

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

Page 20

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

Page 21

12.

Set the FLOW ADJUSTMENT for a flow

slightly LESS than the flow that the insufflator can

provide.

Push the MANUAL control button and adjust FLOW

ADJUSTMENT control for the desired flow as

indicated on the SET FLOW BAR GRAPH.

Observe the effect of a complete cycle by noting the

pneumoperitoneal

pressure

on

insufflator

gauge/indicator before the Crystal VisionTM starts to

operate and immediately after the pump stops. The

intra- abdominal pressure should not drop more than 1-2

mmHg. If it does, reduce the flow on the Crystal

VisionTM FLOW ADJUSTMENT and repeat the

process until the pressure drops very slightly. It is

important to set the Crystal VisionTM flow as high as

possible without diminishing the pneumoperitoneal

pressure.

obstructions in the Trocar sheath. The CHANGE

FILTER indicator always lights when the OCCLUSION

indicator comes on.

16.

OVER PRESSURE occurs when a pressure

more than 27 mmHg (±10% and 1 digit) is detected by

the CRYSTAL VISION. When this happens, the

OVER PRESSURE lamp and audio indicators turn on.

If the pressure exceeds 30 mmHg (±10% and 1 digit)

the CRYSTAL VISION pump starts and attempts to

reduce the over pressure situation. DO NOT EXCEED

30 mmHg PRESSURE!

17.

NO PRESSURE indicator illuminates when

the Trocar sheath is turned off, the tubing set is not

connected to the Trocar sheath, or the ULPA Input

Filter with water trap is not connected to the input filter

connector.

IF SMOKE PERSISTS WHEN

THE PUMP STOPS BE SURE

THAT

NOTE:

The BARGRAPHS indicate the desired

maximum Flow. The DIGITAL FLOW

METER indicates the actual Flow

occurring at that moment. The meter

will read zero when the pump is off.

The meters are RED in HIGH (OPEN)

FLOW and GREEN in LOW (LAP)

FLOW.

 Leur lock on the cannula is open,

 Tubing is not crimped,

 ULPA Input Filter with water trap is clean,

may need to be replaced if it is clogged,,

 Inspect for leaks at the Trocar sheaths, tubing,

or instruments:

13.

The MANUAL control can be used to start the

vacuum pump if smoke still exists when the TIMER

CONTROL is set for the maximum amount of time. Be

sure to monitor the pneumoperitoneal pressure so that it

does not fall more than a few mmHg (adjust the FLOW

ADJUSTMENT, if necessary).

 Increase the TIME CONTROL if there are no

leaks.

 If TIME CONTROL is set to maximum time,

use the MANUAL button until the abdominal

cavity is smoke free. Do not use it excessively,

or the pneumoperitoneum will collapse.

PROCEDURES WITH LARGE

QUANTITIES OF FLUIDS

OPERATIONAL HINT:

The TIME CONTROL can be used to

conserve insufflator gas by reducing

the amount of time that the Crystal

Vision pumps after lasing stops. This

process requires more attention from

the circulating nurse, or the laser

operator.

Suctioning large quantities of fluids will shorten the life

of the ULPA Input Filter with water trap. To extend the

ULPA Input Filter with water trap life, use a suction

canister and non-sterile suction tubing set. Connect the

sterile ESU shroud to the canister and then connect the

non-sterile suction tubing set between the canister and

the ULPA Input Filter with water trap. The canister and

non-sterile suction tubing sets are available from I. C.

Medical.

14.

CHANGE FILTER illuminates when the

ULPA Input Filter with water trap needs to be changed.

.

15.

OCCLUSION indicator lights when flow

virtually ceases from the pneumoperitoneum. Check for

kinked tubing, closed Leur lock on the Trocar sheath,

severely clogged ULPA Input Filter with water trap,

heavy fluid accumulation in the water trap, or

15

Page 22

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, controls, and indicators.

3.

Refer to Figure 17.

4.

Connect ULPA Input Filter with water trap to the

Crystal VisionTM.

Crystal Vision

350D

C

.

I. C. MEDICAL, INC

FLOW SET

HIGH LOW

MAX

- 20

- 16

-

- 13

-

FILTER

-

-

WARNING!

FILTER & TUBING

ARE SINGLE

PATIENT USE

ONLY. DO NOT

WASH,

STERILIZE, OR

RE-USE.

Connect Disposable Sterile Tubing Set to laser

speculum port and to the ULPA Input Filter with

water trap.

6.

Connect ESU and/or LASER SENSOR CABLE to

SENSOR ASSEMBLY and the Crystal VisionTM.

7.

Plug Crystal VisionTM into power outlet and turn

on MAIN POWER SWITCH on back panel. Turn

on front panel ON/OFF SWITCH.

8.

Set HIGH (OPEN)/LOW (LAP) FLOW SWITCH

to HIGH (OPEN) FLOW

9.

Set FLOW ADJUSTMENT for the desired flow as

indicated on the HIGH (OPEN) FLOW BAR

GRAPH.

TIME

88

88

L/MIN

MANUAL

HIGH

SEC

-8

-

CRYSTAL VISION EBS MIN ICM-350D

5.

FLOW

- 11

- 10

-9

-7

-6

-4

LOW

OCCLUSION

LASER

ESU

CHANGE FILTER

I/O

OVER PRESSURE

NO PATIENT

Figure 17: Set up for gynecology procedure for either ESU

or CO2 laser delivered through a colposcope or

Micromanipulator.

10. Push MANUAL button and observe that desired

flow is shown on the DIGITAL FLOW METER.

11. Set TIME CONTROL for the desired amount of

time that the Crystal VisionTM runs after the smoke

producing equipment is shut off.

12. Increase the FLOW ADJUSTMENT and/or the

TIME CONTROL if smoke is not eliminated from

the uterus.

13. CHANGE FILTER light may indicate a partially

obstructed speculum port or smoke tubing. Check

and clean them, if necessary. The ULPA Input

Filter with Water Trap may also need to be

changed.

14. OCCLUSION alarm indicates obstructed speculum port,

kinked, or obstructed tubing. Check and clean as

necessary. It may also mean that the ULPA Input

Filter with Water Trap has become extremely filled

with smoke particles. Replace it, if required.

16

Page 23

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, controls, and indicators.

3.

Refer to Figure 18 or 19.

4.

Connect ULPA Input Filter with Water Trap to

Crystal VisionTM.

5.

Connect Laser Hand piece Accessory or ESU

Handpiece Accessory to the ULPA Input Filter with

Water Trap.

6.

Connect ESU to the Crystal VisionTM connector or

Laser Sensor Cable to Sensor Assembly and the

Crystal VisionTM.

TM

7.

Plug Crystal Vision

8.

Turn on main POWER switch on back panel. Turn

on front panel ON/OFF switch.

9.

Set HI/LOW flow switch to HIGH (OPEN) flow

Crystal Vision

350D

C

FLOW SET

.

HIGH LOW

MAX

- 20

- 16

-

I. C. MEDICAL, INC

88

SEC

MANUAL

HIGH

- 10

-9

-

-8

ARE SINGLE

PATIENT USE

ONLY. DO NOT

WASH,

STERILIZE, OR

RE-USE.

LOW

-7

-6

-

CRYSTAL VISION EBS MIN ICM-350D

Smoke Plume

Collection Tube

TIME

88

L/MIN

- 11

-

WARNING!

FILTER & TUBING

FLOW

- 13

-

FILTER

LASER

OCCLUSION

ESU

I/O

CHANGE FILTER

OVER PRESSURE

-4

NO PATIENT

INPUT

ULPA

FILTER

Smoke

Plume

Remote Activation Device

PATIENT

into power outlet.

Figure 18: Set up for using Crystal VisionTM with an ESU

system during an open procedure.

10. Set FLOW adjustment for the desired flow as

indicated on the HIGH (OPEN) flow bar graph.

11. Push MANUAL button and observe that desired

flow is shown on the digital FLOW meter.

C .

I. C. MEDIC AL, INC

Crystal

Vision

350D

FLOW

SET - 16

HIGH LOW

MAX

- 20

-

- 13

FILT ER

FLOW

TIME

88

88

L/MIN

MANUAL

SEC

HIGH

-

- 11

- 10

-9

WARN ING!

FILT ER &

ARE

TUBING

PAT IENT

SINGLEDO

ONLY.

USE

WASH,

NOT

STER ILIZE,

REOR

USE.

CRYST

AL VISION EBS

MIN ICM-350D

12. Set TIME control for the desired amount of time

that the Crystal VisionTM runs after the smoke

producing equipment is deactivated.

Smoke

Collection

plume

tube

-8

-7

-6

-4

LOW

LASER

OCCLU SIO

CHANGE

N

FILT ER

OVER

NO

PRESSUR

E

PAT IENT

ESU

I/O

INPU

TULPA

FILTE

R

Laser

Handpiece

IF SMOKE PERSISTS DURING THE

SURGICAL PROCEDURE, TRY THE

FOLLOWING.

Laser smoke

collection

plume

STYLIZE

accessory

D

13. Increase the FLOW ADJUSTMENT and/or the

TIME CONTROL if smoke is not eliminated from

the surgical site.

Laser foot

switch

SMOKE

PLUME

PATIEN

T

14. CHANGE FILTER light may indicate a partially

obstructed speculum port or tubing. Check and

clean them, if necessary. The ULPA Input Filter

with Water Trap may also need to be changed.

Figure 19: Using a Crystal VisionTM with a laser

hand piece.

17

Page 24

15. OCCLUSION alarm indicates an obstructed smoke

collection nozzle, kinked or obstructed smoke

tubing. Check and clean as necessary. It may also

mean that the ULPA Input Filter with Water

Trap has become extremely filled with smoke

particles. Replace it, if required.









OTHER ACCESSORIES

IF SMOKE PERSISTS WHEN

THE PUMP STOPS BE SURE

THAT:

Tubing is not crimped

ULPA Input Filter with Water Trap is clean,

may need to be replaced if it is clogged

Be sure there are no leaks in the tubing, or

instruments:

Increase the TIME CONTROL if there are no

leaks.

PROCEDURES WITH LARGE QUANTITIES OF

FLUIDS:

Suctioning large quantities of fluids will shorten the life

of the ULPA Input Filter with Water Trap. To extend

the ULPA Input Filter with Water Trap life, use a

suction canister and non-sterile suction tubing set.

Connect the sterile ESU shroud to the canister and then

connect the non-sterile suction tubing set between the

canister and the ULPA Input Filter with Water Trap.

The canister (ICM-000-0082) is available from I. C.

Medical.

PENEVAC ACCESSORIES:

PenEvac accessories may also be used with the Crystal

VisionTM Model 350-D, 360, or 250-D. The PenEvac

combines the function of an ESU pencil and smoke

evacuator into a single hand-held device. The PenEvac

also has a telescoping tip that enables the surgeon to

change the length of the electrode without actually

replacing the electrode. Several styles of electrodes are

available. The PenEvac is available as a disposable

single-use.

18

Part number

Description

ICM-000-0021

Non-Sterile Speculum Tubing

ICM-000-0027

Sterile Speculum tubing

ICM-000-0075

Sterile Smoke Evacuator Wand

ICM-000-0098

Sterile PenEvac Smoke Tube

ICM-000-0274

Non-Sterile 2’ Smoke Tube with 10mm

Swivel Connector

ICM-000-0347

Sterile 15 mm Smoke Tube

Page 25

THEORY OF OPERATION

The Crystal VisionTM 350-D was designed to effectively

remove smoke during surgical procedures and to

eliminate problems associated with other types of smoke

evacuators. The Crystal VisionTM automatically turns on

when the surgeon activates a smoke-producing device

and it turns itself off when it is not needed to remove

surgical smoke. The 350-D has two flow ranges to

provide optimal performance under a variety of surgical

conditions. In addition, the evacuator notifies the

operator of conditions that may limit the effective

removal of smoke.

PNEUMATIC CIRCUITS

Surgical Smoke collection devices are used to remove

smoke from the surgical site and deliver it through the

fluid trap and into the ULPA rated 0.1 micron input

filter. The filtered air then travels from the input filter,

through either the HIGH (OPEN) Flow or LOW (LAP)

Flow pneumatic circuits, into the pump, then through

the output charcoal 0.5 micron filter and finally

delivered back into the operating room.

ELECTRONIC CIRCUITS

2.

The Manual switch also starts the pump if it is

pushed. This switch is used during procedures to

activate the pump if a remote sensor is not used

with all of the active smoke producing devices.

The switch can also be used when very low flow

insufflators are used during laparoscopic

procedures. It is helpful in this circumstance

because increasing the flow rate would deflate the

pneumoperitoneal pressure. Instead, the flow

TIME can be set to 30 seconds and if additional

purging is required, the MANUAL switch will

continue the evacuation.

3.

An OVER PRESSURE condition: When the

evacuator is in the LOW (LAP) FLOW range,

the pressure in the pneumoperitoneum is

monitored.

When the pressure reaches

approximately 27 mmHg, a light alert is activated.

If the pressure continues to build to 30 mmHg,

the pump is started and it continues to operate

until the pressure drops below 30 mmHg. The

pressure is not monitored in HIGH (OPEN)

FLOW because this range is not intended to be

used during closed (laparoscopic) procedures.

STOP PUMP:

START PUMP:

When the smoke producing device is deactivated, the

manual switch released, or the OVER PRESSURE

condition ceases, the pump will continue to operate for

the amount time shown on the TIME readout on the

front panel.

There are three ways to start the pump: trigger a

remote sensor, push the MANUAL button on the front

panel, or an OVER PRESSURE condition.

1. Remote Sensors: Remote sensors are attached to

the front panel at the ESU or LASER plug. Both

plugs are electrically identical and can be used

interchangeably with either sensor.

a) The LASER sensor consists of an infrared

transmitter and receiver that are carefully

positioned on a foot switch that activates a

surgical laser. Placement is critical because it

is very important to position the infrared

beam so that it is interrupted at the first

movement of the foot pedal. In this manner,

the evacuator is started before the laser

actually activates and the air stream is already

moving when the laser beam first strikes

tissue.

Whenever an OCCLUSION condition is sensed, the

pump will stop. After a brief period of time, if any

start condition exists, it will attempt to restart to see if

the occlusion has been cleared. If it has not, the pump

will again stop. This will continue until the occlusion

is cleared, or until TIME expires.

TIME CONTROL:

The TIME control is used to adjust the amount of time

that the evacuator continues to pump after the active

smoke producing device (laser, ESU, etc.) is

deactivated. This lag in the deactivation of the

evacuator is necessary in order to remove any residual

smoke from the surgical site. The control is variable

from approximately 2 to 30 seconds.

b) The ESU sensor is placed on, or near the

input connector of the electrocautery pencil

cable and the other end is plugged into the

evacuator front panel. Activation of the ESU

pencil is detected by the sensor. The remote

sensor (ESU or Laser) sends a trigger,

through the front panel board, the logic board,

and then to the motor controller.

19