CRYSTAL VISION Model 450-D Operating and Installation Manual Rev C July 2016

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I. C. MEDICAL, INC.

CRYSTAL VISION®

Model 450D

REF

ICM-450-0000

OPERATING AND INSTALLATION MANUAL

I. C. Medical, Inc.

2340 W. Shangri La Road

Phoenix, Arizona 85029 USA

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

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

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

Made in USA

Copyright 1996-2005. All rights reserved.

Document#: ICM-450-9000 Rev: C Date: 2016-07

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Table of Figures

Figure 1: Filters and Power Cord Installation .................................................................................................................4

Figure 2: ESU sensor installation when used with an electrosurgical unit (ESU) ............................................................4

Figure 3: Laser Sensor Installation .................................................................................................................................5

Figure 4: Laser Sensor Installation to the SIDE of the laser foot switch HOUSING........................................................5

Figure 5: Sensors should be positioned so that ANY movement of the pedal interrupts the beam. ..................................6

Figure 6: ON/OFF power switch description. .................................................................................................................7

Figure 7: Manual and Time Control locations. ...............................................................................................................7

Figure 8: Flow buttons. ..................................................................................................................................................8

Figure 9: ON/OFF power switch location.......................................................................................................................9

Figure 10: Manual button and sensor connectors. ...........................................................................................................9

Figure 11: Adjustment for time setting. ........................................................................................................................10

Figure 12: Setting the flow RANGE.............................................................................................................................10

Figure 13: Selecting the desired flow. ..........................................................................................................................11

Figure 14: Front Panel Indicators. ................................................................................................................................11

Figure 15: Input Filter connector. Charcoal Output Filter .............................................................................................12

Figure 16: Laparoscopy set up when using the CRYSTAL VISION®. .......................................................................13

Figure 17: Set up for gynecology procedure for either ESU or CO2 laser delivered through a colposcope or

Micromanipulator .................................................................................................................................................15

Figure 18: Set up for using CRYSTAL VISION® with an ESU system during an open procedure. ..........................16

Figure 19: Set-up for using a CRYSTAL VISION® with a laser hand piece. ..............................................................16

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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 Vision®, 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

IC. Medical, Inc. to be qualified to do so.

Caution risk of danger or Attention, consult ACCOMPANYING DOCUMENTS

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.

The device is Class 1,

Type BF applied part

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%.

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.

 If the equipment is modified, appropriate inspection and testing must be conducted to ensure continued

safe use of equipment.

 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). Turn OFF the unit when replacing the

filter. Replace the Output Filter as soon as odors become noticeable, or every three months, whichever

occurs first.

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.

 Keep unit at operating environment for at least 6(six) hours before use, if unit was exposed to extreme

shipping and storage conditions.

 Make sure the unit is in a safe and stable environment as to prevent falling or being dropped, which may

cause damage.

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Crystal Vision® Model 450D

SPECIFICATIONS

INTENDED USE:

The CRYSTAL VISION® 450D is intended to remove smoke created in any surgical

procedure. It is especially useful during laparoscopy and thoracoscopy procedures. 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.

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 450D automatically activates when active (smoke producing) devices that are

coupled to the Model 450D with special sensors are turned on. The Model 450D

automatically turns off, at a time predetermined by the operator, after the active device

turns off. The Model 450D 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 450D can also be used to evacuate CO2 gas from the pneumoperitoneum at the

end of laparoscopic procedures.

PRODUCT DISPOSITION

At the end of service life, dispose of product in accordance with your institutional protocol

for capital equipment. I.C. Medical, Inc. has defined the service life for the Crystal Vision®

as 20 years from date of manufacture.

SIZE:

7.2"H x 14.07"W x 15.05"D (18.28cm H x 35.73cm W x 38.22cm 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

10o - 25o C, 30-75%RH, 700-1060hPa.

POWER REQUIREMENTS:

100-240 VAC, single phase, and 4.0 A, 47-63 Hz

LEAKAGE CURRENT:

<100 μamps, Conforms to IEC 60601-1

FUSE RATING:

F4AH 250V.

FLOW RATE:

OPEN RANGE:

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 -350mmHg.

MANUAL START SWITCH:

YES

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INDICATORS:

POWER ON

OPEN FLOW ON

LAP FLOW ON

OCCLUSION

CHANGE FILTER

NO PATIENT

OVER PRESSURE

OPEN FLOW RATE

LAP FLOW RATE

OPEN FLOW SET POINT

LAP FLOW SET POINT

TIME SETTING

FLOW READING

Visual Indicator

Visual Indicator

Visual Indicator

Visual & Audio Indicators

Visual Indicator

Visual Indicator

Visual & Audio Indicators

LED Meter

LED Meter

LED Display

LED Display

LED Meter

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

99.9975% Efficient

CHARCOAL OUTPUT FILTER:

RE-USABLE, REPLACE WHEN NOTICEABLE ODOR IS DETECTED, OR

EVERY THREE MONTHS, WHICHEVER OCCURS FIRST.

TURN OFF THE UNIT WHEN REPLACING THE FILTER.

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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INSTALLATION/OPERATIONS

INSTRUCTIONS

WARNINGS:

IMPORTANT NOTICE:

 Use only under the direction of a licensed

physician.

 Do not exceed 27-mmHg intra-abdominal

pressure.

 Do not use OPEN MODE in Laparoscopic

Procedure

 Do not re-use, disposable Sterile Tubing Sets,

PenEvac1®, and Disposable ESU Shrouds

that are SINGLE USE ONLY.

During

laparoscopic

procedures,

the

®

CRYSTAL VISION 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 VISION® 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.

The CRYSTAL VISION® Model 450D is intended to

remove smoke created in any surgical procedure. It is

especially useful during laparoscopy and thoracoscopy

procedures. 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.

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 450D automatically activates when active

(smoke producing) devices that are coupled to the Model

450D with special sensors are turned on. The Model 450D

automatically turns off, at a time predetermined by the

operator, after the active device turns off.

The Model 450D 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 450D 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 VISION®:

ESU Sensor Assembly ICM-000-0009

Laser Sensor Assembly with Cable (ICM-000-0018).

Hospital Grade Power Cord.

Charcoal Output Filter ICM-000-0025.

Ulpa Filter w/water trap ICM-000-0014 or ICM-000-0434.

Installation and Operating Instructions.

Be sure that you have inspected them for any sign of

damage.

FILTERS and POWER CORD

INSTALLATION:

1.

2.

3.

4.

Attach the Charcoal Output Filter to the connector on

the back of the CRYSTAL VISION®.

Attach the Ulpa filter w/water trap to the connector on

the front of the CRYSTAL VISION®..

Attach the power cord to the CRYSTAL VISION®.

Refer to Figure 1.

Figure 1: Filters and Power Cord Installation

ESU SENSOR INSTALLATION:

If you are going to use your CRYSTAL VISION® with an

electrosurgical unit (ESU), proceed with the following:

1.

Plug the ESU sensor connector into the ESU

connector on the CRYSTAL VISION® front panel.

(The Laser connector may also be used.)

2.

Place the ESU sensor on the sides of ESU Generator

as showed on Figure 2.

3.

The CRYSTAL VISION® will now turn ON any time

that the accessory is activated.

Figure 2: ESU sensor installation when used

with an electrosurgical unit (ESU)

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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 3) to the LASER

connector on the CRYSTAL VISION® 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

VISION®.

(NOTE: When the red light goes off, CRYSTAL

VISION® will start to operate).

Test the Sensor Assembly for proper operation:









Figure 3: Laser Sensor Installation

Plug the Sensor Cable into the Sensor

Connector Box and the LASER connector of

the CRYSTAL VISION®.

Plug the CRYSTAL VISION® 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 VISION® starts.

Move the Sensor until the red light comes on.

The pump in the CRYSTAL VISION® will

stop operating sometime within 35 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 VISION® 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 (Figure 4), 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.

Figure 4: Laser Sensor Installation to the SIDE

of the laser foot switch HOUSING.

WITHOUT REMOVING THE PROTECTIVE

COVERING ON THE TAPE, position them so

that the red light comes on.

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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

FOOT PEDAL

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.)

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.

(a)

FOOT PEDAL

TRANSMITTER

OR

RECEIVER

(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 VISION®

1.

The CRYSTAL VISION®. power switch (Figure 6) 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.

2.

Adjust the TIME by pressing the push buttons (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 push

button (Figure 7) on front panel is depressed and stop

operating within approximately 2 seconds after the

button was released.

4.

Adjust TIME by pressing the push button arrow Up to

maximum, it should read 35 seconds. Press the

MANUAL button. The pump should start and then

stop approximately 35 (thirty five) seconds after the

button was released

5.

Figure 6: ON/OFF power switch description.

Adjust TIME by pressing the push button arrow

Down until the TIME display reads 2 seconds. Press

and release the MANUAL button. The pump should

start and then stop approximately 2 seconds after the

button was released.



NOTE:

The Up and Down arrow buttons adjust the

desired FLOW rate on the Flow Setting display.

The digital FLOW READING displays the

actual flow through the Crystal Vision®.

The OPEN (Orange) button and LAP (Green)

button changes the operating mode of the unit

The operating mode of Crystal Vision® is

indicated by the LED situated above OPEN and

LAP push buttons.

Figure 7: Manual and Time Control locations.

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6.

The FLOW SETTING buttons (Up and Down

arrows), (Figure 8), adjusts the desired Flow level on

the Flow Setting display. The Flow Reading digital

meter indicates the actual Flow through the unit. Some

RF noise may cause the Flow Set and Flow Reading

to flicker, however it will not affect the actual flow or

the functionality of the CRYSTAL VISION®.

7.

Push OPEN Button. Orange LED indicator should

light up. Adjust Flow setting to maximum (95 l/min)

by pushing Flow Setting Up arrow button. Press

Manual button, pump should start. Flow Reading

display should indicate at least 90 l/min.

8.

Push LAP button. Green LED indicator should lit up.

Set the Flow Setting to minimum (4 l/min) by pushing

Flow Setting arrow button down. Press Manual

button, pump should start. Flow reading display

should indicate 4 (±1) l/min. Repeat the process for

maximum flow. The Flow Reading display should

indicate at least 18 l/ min.

9.

Place a finger over the ULPA Input Filter with water

trap input and press the MANUAL button. The

CHANGE FILTER and OCCLUSION LEDs should

lit up. The OVER PRESSURE indicator requires

special test equipment and should be tested only by

trained qualified personnel.

Figure 8: Flow buttons.

10. For any problems, or if the CRYSTAL VISION® fails

to perform as indicated, contact I. C. Medical, Inc.

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DESCRIPTION OF SWITCHES,

CONTROL BUTTONS &

INDICATORS

The Sensor Assembly and the Charcoal Output Filter

should already be installed according to the

INSTALLATION INSTRUCTIONS.

1.

ON/OFF SWITCH is located on the back

panel (Figure 9) next to the power cord. This

switch controls the power to the CRYSTAL

VISION®. International symbols are used.

The [I] symbol indicates power "ON" and [O]

indicates "OFF." This switch also controls the

cooling fan.

2.

MANUAL button (Figure 10) used to turn the

CRYSTAL VISION® ON when the surgeon is

not activating a smoke-producing device. This

is particularly helpful when insufflators are

used that deliver 6 liters-per-minute or less.

The MANUAL button can be used to clear

residual plume during these situations in (LAP)

procedures. 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).

3.

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.

4.

ESU CONNECTOR (Figure 10) is the input

for the ESU SENSOR CABLE. This sensor

can be used with a variety of devices to

activate the CRYSTAL VISION®.

Figure 9: ON/OFF power switch location.

Figure 10: Manual button and sensor connectors.

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5.

TIME SETTING Buttons (Up and Down

arrows) (Figure 11) varies the amount of time

that the CRYSTAL VISION® 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

VISION® 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.

Figure 11: Adjustment for time setting.

TIME DISPLAY (METER) (Figure 11)

indicates the amount of time that the

CRYSTAL VISION® will operate after the

foot switch, or hand switch, is deactivated (2

sec min- 35 sec max)

6.

OPEN and LAP buttons (Figure 12) selects the

flow range of the vacuum pump. The operator,

according to the type of procedure selects the

range. LAP MODE SHOULD BE

SELECTED FOR ALL LAPAROSCOPIC

PROCEDURES and the readouts are

GREEN. OPEN MODE should be used during

open and external cases when plume is being

eliminated through a handpiece. Using OPEN

MODE during laparoscopy will quickly deflate

the pneumoperitoneum. The OPEN and LAP

buttons also select the corresponding FLOW

SETTING.

7.

Only one of the LED mode indicators is

illuminated at a time. This eliminates

confusion of which mode is used.

Figure 12: Setting the flow RANGE.

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8.

FLOW SETTING control buttons (Figure 13)

sets the maximum flow that is desired by the

surgeon. This value is indicated on the FLOW

SETTING display.

9.

FLOW READING (Figure 13) is registering

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.

10.

CHANGE FILTER indicator is located above

filter (Fig. 14). It illuminates when there is a

reduced flow into the CRYSTAL VISION®.

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.

11.

Figure 13: Selecting the desired flow.

OCCLUSION indicates that flow into the

CRYSTAL VISION® 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 pump failure,

the CRYSTAL VISION® pump will not

activate when this lamp is illuminated.

Figure 14: Front Panel Indicators.

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12.

OVER PRESSURE indicates pressure

exceeding 27 mmHg in the pneumoperitoneum

(Figure 14). At pressures over 30 mmHg, the

vacuum pump starts in order to reduce the

pressure in the pneumoperitoneum. 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.

13.

The "NO PATIENT" indicator (Figure 14)

turns on when the CRYSTAL VISION® is in

the LAP MODE, 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.

14.

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 (connector not shown)

(Figure 15). The Charcoal OUTPUT FILTER

CONNECTOR is located on the back panel of

the CRYSTAL VISION®. The Charcoal

Output filter- is reusable for several cases. The

Charcoal Output filter has a functional life of

three months. The Charcoal Output filter

provides odor control and reduces vacuum

pump noise.

15.

Figure 15: Input Filter connector. Charcoal

Output Filter

Do not operate the unit without a

Charcoal Output filter.

12

Page 19

LAPAROSCOPIC OPERATION

6.

Plug CRYSTAL VISION® into power outlet.

FOR BEST RESULTS:

7.

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.

8.

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 VISION® to the

laparoscope port.

*ICM-000-0448 Non-sterile Intra-Abdominal

Plume Eliminator Tubing Set is available.

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 for set-up instructions.

10. Select LAP Mode on CRYSTAL VISION® by

pushing LAP button.

4.

Connect ULPA Input Filter with water trap.

11. Adjust TIME SETTING to maximum.

5.

Connect sensor LASER SENSOR and/or the ESU

SENSOR, as desired, to the CRYSTAL VISION®

front panel.

9.

Turn ON POWER SWITCH

CRYSTAL VISION®.

Figure 16: Laparoscopy set up when using the CRYSTAL VISION®.

13

on back of

Page 20

15.

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!

Set the FLOW SETTING for a flow slightly LESS than

the flow that the insufflator can provide.

Push the MANUAL button.

Observe the effect of a complete cycle by noting the

pneumoperitoneal

pressure

on

insufflator

gauge/indicator before the CRYSTAL VISION® 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

VISION® FLOW SETTING and repeat the process

until the pressure drops very slightly. It is important to

set the CRYSTAL VISION® flow as high as possible

without diminishing the pneumoperitoneal pressure.



16.

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 FLOW SETTING indicates the

desired maximum Flow. The FLOW

READING display indicates the actual

Flow occurring at that moment. The

meter will read zero when the pump is

off. The meters are ORANGE in OPEN

Mode and GREEN in LAP Mode.

 Leur lock on the cannula is open,

12.

The MANUAL button can be used to start the

vacuum pump if smoke still exists when the TIME

SETTING 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

SETTING, if necessary).

 Increase the TIME SETTING if there are no

leaks.

 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,

 If TIME SETTING 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.

OPERATIONAL HINT:

PROCEDURES WITH LARGE

QUANTITIES OF FLUIDS

The TIME SETTING 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.

13.

CHANGE FILTER illuminates when the

ULPA Input Filter with water trap needs to be changed.

14.

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

obstructions in the Trocar sheath. The CHANGE

FILTER indicator always lights when the OCCLUSION

indicator comes on.

.

14

Page 21

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 for set-up .

4.

Connect ULPA Input Filter with water trap to the

CRYSTAL VISION®.

5.

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

VISION®.

Figure 17: Set up for gynecology procedure for

either ESU or CO2 laser delivered through a

colposcope or Micromanipulator

®

7.

Plug CRYSTAL VISION into power outlet and

turn on POWER SWITCH on back panel.

8.

Push OPEN (Orange) button.

9.

Adjust FLOW SETTING for the desired flow rate

indicated on the display.

10. Push MANUAL button and observe the actual flow

indicated by FLOW READING display. Adjust

FLOW SETTING if necessary.

11. Adjust TIME SETTING for the desired amount of

time that the CRYSTAL VISION® runs after the

smoke producing equipment is shut off.

12. Increase the FLOW SETTING and/or the TIME

SETTING 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.

15

Page 22

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 for set-up.

4.

Connect ULPA Input Filter with Water Trap to

CRYSTAL VISION®.

5.

Connect Laser Hand piece Accessory or ESU

Handpiece Accessory to the ULPA Input Filter with

Water Trap.

6.

Connect ESU sensor to ESU port of the CRYSTAL

VISION® or Laser Sensor Cable to Sensor

Assembly and the CRYSTAL VISION®.

7.

Plug CRYSTAL VISION® into power outlet.

8.

Turn ON POWER switch on back panel.

9.

Push OPEN (Orange) button. Indicator should

illuminate.

Figure 18: Set up for using CRYSTAL VISION® with

an ESU system during an open procedure.

10. Adjust FLOW SETTING for the desired flow.

11. Push MANUAL button and observe that desired

flow is shown on the digital FLOW meter display

12. Adjust TIME SETTING for the desired amount of

time that the CRYSTAL VISION® runs after the

smoke producing equipment is deactivated.

IF SMOKE PERSISTS DURING THE

SURGICAL PROCEDURE, TRY THE

FOLLOWING.

13. Increase the FLOW SWTTING and/or the TIME

SETTING if smoke is not eliminated from the

surgical site.

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: Set-up for using a CRYSTAL VISION® with

a laser hand piece.

16

Page 23

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 SETTING if there are no

leaks.

Part number

Description

ICM-000-0021

Speculum Tubing, Non-Sterile

ICM-000-0027

Speculum Tubing, Sterile

ICM-000-0075

Smoke Evacuator Wand, Sterile

ICM-000-0098

Smoke Evacuator Tube, Sterile

ICM-000-0274

2’Tube with 10mm Swivel, NonSterile

ICM-000-0347

15 mm Smoke Tube, Sterile

Other options are available. Please refer to

http://www.icmedical.com for further information.

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.

PENEVAC1® ACCESSORIES:

PenEvac1® accessories 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 device.

The

PenEvac1® 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 PenEvac1® is available as

a disposable single-use.

Description

Part number

ICM-000-0450

PenEvac1®, SS Blade, Tube &

Holster, Sterile

ICM-000-0452

PenEvac1®, Non-Stick Blade, Tube

& Holster, Sterile

ICM-000-0458

PenEvac1®, Megadyne E-Z Clean

Blade, Tube & Holster, Sterile

Other options are available. Please refer to

http://www.icmedical.com for further information.

17

Page 24

THEORY OF OPERATION

The CRYSTAL VISION® Model 450D was designed to

effectively remove smoke during surgical procedures

and to eliminate problems associated with other types of

smoke evacuators.

The CRYSTAL VISION®

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 Model 450D

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 OPEN or LAP pneumatic circuits,

into the pump, then through the output charcoal 0.5

micron filter and finally delivered back into the

operating room.

2.

The Manual button also starts the pump if it is

pushed. This push button 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 35 seconds and if additional

purging is required, the MANUAL button will

continue the evacuation.

3.

An OVER PRESSURE condition: When the

evacuator is in the LAP Mode, 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 OPEN Mode because this range is not intended

to be used during laparoscopic procedures.

STOP PUMP:

ELECTRONIC CIRCUITS

When the smoke producing device is deactivated,

MANUAL button not pressed, or the OVER

PRESSURE condition is not present, the pump will

continue to operate for the amount time shown on the

TIME SETTING on the front panel.

START PUMP:

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 SETTING:

The TIME SETTING buttons are 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 35 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, to the Master

Board, and then to the motor controller.

18

Page 25

CHANGE FILTER light is illuminated. The pump is

not stopped unless the restrictions are allowed to

continue (filter gets fuller) and an occlusion is sensed.

FLOW SETTING:

The FLOW SETTING control buttons vary the speed

of the vacuum pump depending on the flow range in

use. OPEN Mode flow is adjustable to at least 90 lpm

and LAP Mode flow from 4 + 1 to at least 18 lpm.

LAP MODE:

LAP flow range is used during laparoscopic (“closed”)

procedures, they are characterized by a limited amount

of gas (air, carbon dioxide, etc.) being available for

evacuation. LAP MODE is used as many insufflators

can only provide 4 - 6 lpm to the cavity. If the FLOW

SETTING is set to evacuate much higher rates, the

pneumoperitoneum will collapse.

Therefore, the

operator needs to balance the FLOW and TIME

SETTINGS to optimize the amount of gas removed at

any one time.

The FLOW SETTING is used only as a general

indicator of what the flow will be when the pump is

started. The purpose of the display is to allow the

operator to preset the desired flow when the pump is

not running. The FLOW READING is meant to

provide a more accurate measure of the flow actually

occurring. There may be relatively large differences

between the FLOW SETTING and the FLOW

READING.

The FLOW READING display provides a good

measure of the actual flow when the pump is running.

The FLOW READING displays 00.0 (Zero) when the

pump is not running. Measuring flow is a very

complicated process. The actual flow through the

pump will vary significantly depending on the

accessories, and the measuring devices used. Be sure

to follow the procedures listed in the Calibration

section explicitly when trying to calibrate, or measure,

the flow through the evacuator.

The LAP MODE is also monitored for Occlusion and

Change Filter conditions. These are monitored by the

same vacuum sensor and uses parallel circuits to those

in the OPEN MODE. For more information, refer to

the OPEN MODE description.

The LAP MODE is also monitored for two other

conditions. The CRYSTAL VISION®, in LAP flow

only, monitors the pressure in the flow circuit when the

pump is NOT running. The NO PATIENT circuit

looks for the presence of a positive pressure to indicate

that the evacuator is attached to the pneumoperitoneum

correctly and that there are no occlusions (typically

closed stopcocks) in the circuit. If the circuit is not

attached to the patient, or a stopcock is closed, or the

filter is completely clogged, the positive pressure in

the pneumoperitoneum cannot be sensed by the

CRYSTAL VISION®. Under these circumstances, the

NO PATIENT lamp comes on. Whenever this light

comes on, it is important to correct the problem

because the evacuator will not be able to monitor the

pressure in the pneumoperitoneum for OVER

PRESSURE conditions nor will it be able to evacuate

smoke when it is generated.

OPEN MODE:

The OPEN MODE is used with the PenEvac1®, ESU

Pencil Shroud™, or other types of surgical smoke

collection 10mm or greater tubing sets.

These

procedures are considered “open” in that the flow of

air and vapor to the surgical site is not restricted like it

is during a laparoscopic or other “closed” procedure.

During the open procedures, higher flow rates are very

desirable to remove effectively all smoke from the site

and to keep it from permeating the operating room.

When the OPEN button is pushed, the high flow

solenoid is activated to select the high flow air circuit.

The flow circuit is monitored by a vacuum sensor in

order to detect an occluded air stream. If an occlusion

is detected, the pump immediately stops to prevent

tissue damage. Within a few seconds, the pump will

attempt to restart. If the occlusion has been cleared,

the pump will run. If the occlusion is still present the

pump will not start and will again attempt a restart in a

few seconds. The restart attempts will continue until

the occlusion is cleared, or until TIME SETTING

expires.

The pneumoperitoneal pressure is monitored (if the

circuit is connected properly and the NO PATIENT

light is out) when the pump is not running. If the

pressure sensed is approximately 27 mmHg, the

OVER PRESSURE light alert is activated until the

pressure drops to below 27 mmHg. If the pressure

exceeds approximately 30 mmHg, then the pump will

start and run for the set time.

.

The flow resistance is also monitored for changes in

restrictions in the air stream that do not represent an

occlusion.

When the set point is exceeded, sensing that the ULPA

filter is no longer effectively capturing particles, the

19