ICMedical CRYSTAL VISION 450D Specification sheet

I. C. MEDICAL, INC.
CRYSTAL VISION®
Model 450D
ICM-450-0000
OPERATING AND INSTALLATION MANUAL
I. C. Medical, Inc.
15002 North 25th Drive
Phoenix, Arizona 85023 USA
Tel: [phone] (USA)
Fax: [phone] (USA)
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Made in USA
Copyright 1996-2020. All rights reserved.
Document#: ICM-450-9000 Rev. N Date: 2021-03
REF

i
Table of Contents
LIMITED WARRANTY: ........................................................................................................................................ III
IMPORTANT SAFEGUARDS AND NOTICES................................................................................................... IV
SERIOUS ADVERSE EVENTS.............................................................................................................................. IV
GENERAL WARNINGS ...........................................................................................................................................V
CONTRAINDICATIONS..........................................................................................................................................V
GENERAL CAUTIONS ............................................................................................................................................V
COMPATIBILITY................................................................................................................................................... VI
SPECIFICATIONS .....................................................................................................................................................1
INSTALLATION/OPERATIONS INSTRUCTIONS ..............................................................................................3
FILTERS AND POWER CORD INSTALLATION: ...............................................................................................4
ESU, RF, OR UNIVERSAL SENSOR INSTALLATION: ......................................................................................5
FOOT SWITCH INSTALLATION/OPERATION..................................................................................................7
LASER SENSOR INSTALLATION .........................................................................................................................8
CHECK PROPER OPERATION OF THE CRYSTAL VISION®.......................................................................10
DESCRIPTION OF SWITCHES, CONTROL BUTTONS & INDICATORS ....................................................12
LAPAROSCOPIC OPERATION ............................................................................................................................16
NON-LAPAROSCOPIC GYNECOLOGY PROCEDURES: ...............................................................................18
OTHER NON-LAPAROSCOPIC PROCEDURES: ..............................................................................................19
THEORY OF OPERATION ....................................................................................................................................21
PNEUMATIC CIRCUITS ........................................................................................................................................21
ELECTRONIC CIRCUITS......................................................................................................................................21
START PUMP:........................................................................................................................................................21
STOP PUMP:...........................................................................................................................................................21
TIME SETTING:.....................................................................................................................................................21
FLOW SETTING: ...................................................................................................................................................22
OPEN MODE: .........................................................................................................................................................22
LAP MODE:............................................................................................................................................................22
TROUBLE SHOOTING GUIDE.............................................................................................................................23
PREVENTIVE MAINTENANCE............................................................................................................................25
CLEANING INSTRUCTIONS: ...............................................................................................................................25
HOSPITAL LEVEL CALIBRATION INSTRUCTIONS .....................................................................................26

ii
Table of Figures
Figure 1: Filters and Power Cord Installation ................................................................................................................4
Figure 2: ESU and RF Sensor installation when used with an electrosurgical generator (ESU).....................................5
Figure 3: UNIVERSAL BLUE RF Sensor installation when used with an electrosurgical generator (ESU) ................6
Figure 4: UNIVERSAL BLUE RF Sensor installation when used with Harmonic Scalpel generator...........................7
Figure 5: Foot Switch Installation .................................................................................................................................7
Figure 6: Laser Sensor Installation................................................................................................................................8
Figure 7: Laser Sensor Installation to the SIDE of the laser foot switch HOUSING. .....................................................8
Figure 8: Sensors should be positioned so that ANY movement of the pedal interrupts the beam..................................9
Figure 9: ON/OFF power switch description...............................................................................................................10
Figure 10: Manual and Time Control locations. ..........................................................................................................10
Figure 11: Flow buttons. .............................................................................................................................................11
Figure 12: ON/OFF power switch location. ................................................................................................................12
Figure 13: Manual button and sensor connectors.........................................................................................................12
Figure 14: Adjustment for time setting........................................................................................................................13
Figure 15: Setting the flow RANGE. ..........................................................................................................................13
Figure 16: Selecting the desired flow. .........................................................................................................................14
Figure 17: Front Panel Indicators. ...............................................................................................................................14
Figure 18: Input Filter Connector holds SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-in Fluid Trap.
Large Coconut Charcoal Output Filter..................................................................................................................15
Figure 19: Laparoscopy Set up when using ESU and Crystal Vision.........................................................................16
Figure 20: Laparoscopy Set up when using CO2 Laser and Crystal Vision ................................................................16
Figure 21: Set up for gynecology procedure for either ESU or CO2laser delivered through a colposcope or
Micromanipulator.................................................................................................................................................18
Figure 22: Set up for using CRYSTAL VISION® with an ESU system during an open procedure. .........................19
Figure 23: Set-up for using a CRYSTAL VISION®with a laser hand piece..............................................................19

iii
LIMITED WARRANTY:
For the periods and the conditions specified below, I.C. Medical, Inc. warrants to the original
purchaser that I.C. Medical, Inc.’s products will perform to our published specifications when used
and maintained in accordance with our written instructions.
If due to a defect in materials or workmanship a Product fails to perform to our published
specification, or if a Consumable is not free from defects in materials and workmanship when
shipped from our factory, I.C. Medical will, at its option, repair or replace the defective Product
or Consumable without charge, using new or remanufactured parts. I.C. Medical reserves the right
to make a repair in its factory, at any authorized repair facility, or at the purchaser's premises.
Factory return shipping charges, if any, shall be paid by the purchaser.
With respect to the Crystal Vision, the warranty period is one (1) year from delivery. The warranty
for the Crystal Vision smoke evacuator is null and void if 1) the purchaser, including any I.C.
Medical, Inc. authorized service provider, attempts to service or repair the smoke evacuator (other
than the performance of routine maintenance as described in the Operator’s Manual), 2) the smoke
evacuator is used other than as specified in the Operator’s Manual, or 3) the smoke evacuator is
used without I.C. Medical’s SAFEGUARD BLUE®Hydrophobic ULPA (Ultra Low Penetration
Air) Filter with Built-in Fluid Trap*. Without limitation, this warranty does not cover damage
caused by customer misuse of the smoke evacuator.
*WARNING: This warranty will only apply when the smoke evacuator is used in conjunction
with I.C. Medical’s SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-in Fluid
Trap. I.C. Medical’s SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-in Fluid Trap
includes a hydrophobic filtration media, and advanced sealing methods, to prevent contaminated
fluid and air from leaking into, and out of, the smoke evacuator. Use of the Crystal Vision smoke
evacuator without I.C. Medical’s SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-
in Fluid Trap can result in particle, air, and fluid leakage that contaminates the smoke evacuator
and affects the efficiency and operation of the smoke evacuator. In addition, particle, fluid and air
leakage resulting from use of the smoke evacuator without I.C. Medical’s SAFEGUARD BLUE®
Hydrophobic ULPA Filter with Built-in Fluid Trap can compromise user and patient safety,
especially in laparoscopy where maintaining patient intra-abdominal pressure is critical. I.C.
Medical’s limited warranty applies to all I.C. Medical branded smoke evacuators and those for
which I.C. Medical is the original equipment manufacturer (OEM). In no event will I.C. Medical
repair any of its smoke evacuators that have been contaminated by using non- I.C. Medical
Hydrophobic ULPA filters either during or after the warranty period.
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 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.

iv
IMPORTANT SAFEGUARDS AND NOTICES
The following pages provide important guidelines for operators and service personnel. Specific warnings and cautions
appear throughout the manual where they apply. Please read and follow this important information, especially those
instructions related to risk of electric shock or injury to patient or staff members.
Any instructions in this manual that require opening the equipment cover or enclosure are for use by I.C.
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.
Symbol Description:
“ON” (power)
“OFF” (power)
Caution
The device is Class 1,
Type BF applied part
Fuse
Earth (ground)
SERIOUS ADVERSE EVENTS
Any serious adverse event or incident that occurs in relation to the device or accessory should be reported
to the manufacturer, I.C. Medical, Inc., at [email protected] and to the FDA. In addition,
European customers should also report to the Authorized Representative at the address listed on the label
or IFU and to the competent authority in the member state.

v
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:
1. Heed all warnings on the unit and in the operating instructions.
2. Do not use this equipment in or near water.
3. This equipment is grounded through the grounding conductor of the power cord. To avoid the risk of electric
shock, this equipment must only be connected to a supply mains with protective earth.
4. Route power cords so they are not likely to be damaged.
5. Disconnect power before cleaning the equipment. Do not use aerosol cleaners, use a damp cloth.
6. Dangerous voltages may exist at several points in this equipment. To avoid injury, do not touch exposed
connections and components while power is on.
7. Do not wear rings or wristwatches when troubleshooting the equipment.
8. 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.
9. Not intended to be used in an Oxygen Rich Environment. Not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
10. Qualified service personnel should perform safety checks periodically and after any service.
11. If the equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use
of equipment.
12. 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.
13. Use only smoke evacuator accessories manufactures by I.C. Medical, as SAFEGUARD BLUE®Hydrophobic
ULPA Filter with Built-in Fluid Trap, Large Coconut Charcoal Output Filter, RF Sensor(s), smoke tubing
disposable and other accessories.
14. Using any other filters, sensors, or accessory, not manufactured or supplied by I.C. Medical, may cause
damage and/or cause the system to be inoperable and may void the warranty.
15. Do not operate unit without SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-in Fluid Trap (for a
complete list of products contact I.C. Medical sales representative).
16. To prevent contamination and for proper operation I.C. Medical SAFEGUARD BLUE®Hydrophobic ULPA
Filter must be properly installed and used at all times.
17. Do not operate machine without Large Coconut Charcoal Output Filter.
18. Turn OFF the unit when replacing the Large Coconut Charcoal Output Filter. Replace the Large Coconut
Charcoal Output Filter as soon as odors become noticeable, or every three months, whichever occurs first.
19. Do not block exhaust.
CONTRAINDICATIONS
A contraindication is a specific situation in which a drug, procedure, or surgery should not be used because it may be
harmful to the person. Observe the following contraindications when using or working on this equipment.
DO NOT use this device for the suction of liquids.
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.
1. When installing this equipment, do not attach the power cord to building surfaces.
2. To prevent damage to equipment when replacing fuses, locate and correct the problem that caused the fuse to
blow before re-applying power.
3. Use only specified replacement parts.
4. Use only smoke evacuator accessories manufactured by I.C. Medical, as SAFEGUARD BLUE® Hydrophobic
ULPA Filter with Built-in Fluid Trap, Large Coconut Charcoal Output Filter, RF Sensor(s), smoke tubing
disposable and other accessories. Using any other filters, sensors, or accessory, not manufactured or supplied by
I.C. Medical, may cause damage and/or cause the system to be inoperable and may void the warranty.
5. Follow precautions for static sensitive devices when handling this equipment.

vi
6. This product should only be powered as described in the manual. To prevent equipment damage, select the proper
voltage outlet.
7. To prevent damage to the equipment, read the instructions in the equipment manual for proper input voltage.
8. Keep unit at operating environment for at least 6(six) hours before use, if unit was exposed to extreme shipping
and storage conditions.
9. Make sure the unit is in a safe and stable environment as to prevent falling or being dropped, which may cause
damage.
COMPATIBILITY
Refer to below compatibility information, Specifications Section, and Installation/Operations Instructions to confirm
that this Crystal Vision Model is compatible with the accessories being used.
The Smoke Evacuator was tested electrically to meet the requirements ANSI/AAMI ES 60601-1 Medical electrical
equipment— Part 1: General requirements for basic safety and essential performance. This unit is compatible with
other IEC 60601-1 certified units.
Electrosurgical equipment (ESU) connected to the auxiliary Mains outlet must be certified according to IEC60601-1,
including Medical Electrical System aspects. Everybody who connects additional equipment to the auxiliary mains
outlet configures a medical system and is therefore responsible that the system complies with the requirements of IEC
60601-1.
For the electromagnetic compatibility (EMC), this smoke evacuator complies with EMC standard for medical
electrical equipment (IEC 60601-1-2).
List of compatible I.C. Medical products:
1. ESU Sensor
2. RF Sensor, Shielded
3. UNIVERSAL BLUE™ RF Sensor
4. Laser Sensor
5. Foot Switch
6. SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-in Fluid Trap
7. Large Coconut Charcoal Output Filter
8. Intra-Abdominal Plume Eliminator Tubing Set
9. Speculum Tubing
10. Smoke Evacuator Wand
11. Smoke Evacuator Tube
12. ESU Shroud
13. PenEvac1
14. Non-Telescopic PenEvac
15. The power cords for smoke evacuator units should be grounded, medical-grade type
In addition, new products released after the introduction of this product may also become compatible with this Crystal
Vision Model. For further details, contact I.C. Medical.
WARNING
If combinations of equipment other than those shown within this manual are used, the full responsibility is assumed
by the medical facility.
Connecting additional equipment, other than one found compatible with, to the auxiliary mains outlet or other inputs
(ESU, Laser) will increase chassis leakage.
Using incompatible equipment can result in patient injury and/or equipment damage.

1
Crystal Vision®Model 450D
SPECIFICATIONS
INDICATION FOR USE: The CRYSTAL VISION® 450D is intended to remove smoke created in surgical procedure.
USED FOR: The CRYSTAL VISION®450D is intended to remove smoke created in surgical procedure.
The Model 450D can be used to remove smoke produced by lasers, electrosurgical devices,
argon beam coagulators, LEEP devices, and other devices that create smoke during surgical
procedures.
During internal surgical procedures such as laparoscopy, it helps to maintain the desired
internal pressure (pneumoperitoneum). The smoke evacuator removes up to 20 liters-per-
minute of smoke produced.
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 CO2gas from the pneumoperitoneum at the end
of la
p
arosco
p
ic
p
rocedures.
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 10
y
ears 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 Large Coconut
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 atmos
p
heric
p
ressure ran
g
e 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
FUSE RATING: F4AH 250V.
FLOW RATE:
OPEN RANGE:
Minimum: N/A Maximum: At least 90 Liters/Minute.
LAP RANGE: Minimum: 4 (±1) lpm Maximum: At least 18 Liters/Minute
ACCURACY:
±10%
MAXIMUM VACUUM: Will not be more negative than -350mmHg.
MANUAL START SWITCH: YES
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

2
SAFEGUARD BLUE®
HYDROPHOBIC ULPA FILTER
WITH BUILT-IN FLUID TRAP:
Multiple Use: Change when CHANGE FILTER illuminates on front panel; replace cap on
input connector when SAFEGUARD BLUE®Hydrophobic ULPA Filter with Built-in
Fluid Trap not in use.
Filtration Efficiency:
Mode Particles at: (in microns)
0.03 0.12 0.3
LAP Efficiency (%) >99.9999 >99.9999 >99.9999
OPEN Efficiency (%) >99.9999 >99.9999 >99.9999
LARGE COCONUT
CHARCOAL OUTPUT FILTER:
Re-usable: Change when noticeable odor is detected, or every three months,
whichever occurs first.
TURN OFF THE UNIT WHEN REPLACING THE FILTER.
Filtration Efficiency:
Mode Particles at: (in microns)
0.03 0.12 0.3
LAP Efficiency (%) 99.86 94.38 91.58
OPEN Efficiency (%) 98.39 85.34 86.80
Studies shows that approximately 77% of the particulate matter in the plume was
less than 1.1 microns in size.
(Mihashi, Ueda, Hirano, Tomita, & Hirohata, 1975);
(Coronaviruses: An Overview of Their Replication and Pathogenesis, Helena Jane
Maier, Erica Bickerton, and Paul Britton; 2015 Feb 12);
The following particulates has a typical size of:
0.01 to 0.1 micron for viruses;
0.01 to 1.0 microns for tabacco smoke;
0.01 to 3.0 microns for combustion gases;
0.06 to 0.14 microns for SARS-CoV-2;
0.1 to 1.0 microns for fumes;
0.1 to 1.0 microns for dust mite feces;
0.1 to 10.0 microns for insecticide dust;
0.1 to 50.0 microns for face powder;
0.4 to 15.0 microns for bacteria;
0.8 to 9.0 microns for lung-damaging dust;
1.0 to 10.0 microns for skin flakes;
1.0 to 10.0 microns for dust mites;
8.0 to 100.0 microns for human hair;
9.0 to 15.0 microns for spores;
10.0 to 100.0 microns for sneezes;
10.0 to 15.0 microns for pollen;

3
INSTALLATION/OPERATIONS
INSTRUCTIONS
1.Use only under the direction of a licensed
physician.
2.Do not exceed 27-mmHg intra-abdominal
pressure.
3.Do not use OPEN MODE in Laparoscopic
Procedure
4.Do not re-use, disposable Sterile Tubing Sets,
PenEvac1®, and Disposable ESU Shrouds that
are SINGLE USE ONLY.
The CRYSTAL VISION®Model 450D is intended to remove
smoke created in surgical procedure. The Model 450D can be
used to remove smoke produced by lasers, electrosurgical
devices, argon beam coagulators, LEEP devices, and other
devices that create smoke during surgical procedures.
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 smoke produced.
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 CO2gas from
the pneumoperitoneum at the end of laparoscopic procedures.
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.

4
The following I.C. Medical’s accessories are compatible, and
need to be use with your CRYSTAL VISION
®
, be sure to
inspect them for any sign of damage:
1. ESU Sensor
2. RF Sensor, Shielded
3. UNIVERSAL BLUE™ RF Sensor
4. Laser Sensor
5. Foot Switch
6. SAFEGUARD BLUE® Hydrophobic ULPA Filter with
Built-in Fluid Trap
7. Large Coconut Charcoal Output Filter
The power cords for smoke evacuator units should be
grounded, medical-grade type
For a complete list of compatible finish product reference
number, please contact I.C. Medical, Inc.
CAUTIONS: Use only smoke evacuator accessories
manufactured by I.C. Medical, Inc. as SAFEGUARD
BLUE
®
Hydrophobic ULPA Filter with Built-in Fluid
Trap, Large Coconut Charcoal Output Filter, RF Sensor(s),
smoke tubing disposable and other accessories.
Using any other filters, sensors, or accessory, not
manufactured or supplied by I.C. Medical, Inc. may cause
damage and/or cause the system to be inoperable and may
void the warranty.
FILTERS and POWER CORD
INSTALLATION:
1. Attach the Large Coconut Charcoal Output Filter to the
connector on the back of the CRYSTAL VISION
®.
2. Attach the SAFEGUARD BLUE
®
Hydrophobic ULPA
Filter with Built-in Fluid Trap to the connector on the front
of the CRYSTAL VISION
®
.
3. Attach the power cord to the CRYSTAL VISION
®
.
4. Refer to Figure 1.
Figure 1: Filters and Power Cord Installation

5
ESU, RF, or UNIVERSAL SENSOR
INSTALLATION:
If you are going to use your CRYSTAL VISION
®
with an
electrosurgical unit (ESU) monopolar or bipolar, ultrasonic
device, harmonic scalpel, proceed with the following:
RF SENSOR
For use with all Crystal Vision
®
Models.
INSTALLATION/OPERATION:
RF Sensor when used with Monopolar Devices
(Figure 2; Option 2; Placement 1 or 2):
1. Plug the RF Sensor’s connector into Crystal Vision Smoke
Evacuator’s ESU/Laser port.
2. Place the RF Sensor, on the monopolar device’s cable (e.g.
PenEvac), by running it through the sensor’s wire clip.
3. Make sure the sensor is installed on top of the wire, with
the clip side facing down, close to the monopolar device’s
plug, to prevent capture of residual RF signal from
surrounding devices.
4. Plug the monopolar device (e.g. PenEvac), into the
Monopolar port of the ESU Generator.
5. Select the “Monopolar” option on ESU Generator.
6. Set ESU Generator’s Cut and Coag value.
7. Activate the monopolar device by depressing cut or coag
button. When the monopolar device activates, the RF
Sensor should turn ON the Crystal Vision Smoke
Evacuator, automatically.
8. When not in use, put away the RF Sensor by attaching the
Velcro side of the RF Sensor to the smoke evacuator.
Perform first-time installation by peeling the back film
from the Velcro loop tape, pressing it firmly to a clean and
dry area on the side of the Smoke Evacuator.
To reuse the RF Sensor simply pull it off from the Smoke
Evacuator’s side.
RF Sensor when used with Bipolar Devices
(Figure 2; Option 1; Placement 1 or 2):
1. Plug the RF Sensor’s connector into Crystal Vision
Smoke Evacuator’s ESU/Laser port.
2. Place the RF Sensor, on the bipolar device’s cable, by
running it through the sensor’s wire clip.
3. Make sure the sensor is installed on top of the wire, with
the clip side facing down, close to the bipolar device’s
plug, to prevent capture of residual RF signal from
surrounding devices.
4. Plug the bipolar device into the Bipolar Port of the ESU
Generator.
5. Select the “Bipolar” option on ESU Generator.
6. Activate the bipolar device. When the bipolar device
activates, the RF Sensor should turn ON the Crystal
Vision Smoke Evacuator, automatically.
Figure 2: ESU and RF Sensor installation when used
with an electrosurgical generator (ESU)

6
7. When not in use, put away the RF Sensor by attaching
the Velcro side of the RF Sensor to the smoke
evacuator. Perform first-time installation by peeling the
back film from the Velcro loop tape, pressing it firmly
to a clean and dry area on the side of the Smoke
Evacuator.
To reuse the RF Sensor simply pull it off from the Smoke
Evacuator’s side.
UNIVERSAL BLUE RF SENSOR
For use with all Crystal Vision® Models
INSTALLATION/OPERATION:
UNIVERSAL BLUE™ RF Sensor when used with
Monopolar Devices
(Figure 3; Option 2; Placement 1 or 2):
1. Plug the UNIVERSAL BLUE™ RF Sensor’s connector
into Crystal Vision Smoke Evacuator’s ESU/Laser port.
2. Place the UNIVERSAL BLUE™ RF Sensor, on the
monopolar device’s cable (e.g. PenEvac), making sure the
sensor is installed on top of the cable, facing down, to
prevent capture of residual RF signal from surrounding
devices.
3. Use both of the self-adhering Velcro straps to wrap around
the sensor and over the monopolar device’s cable, to secure
the cable to the sensor at both ends of the sensor.
4. Plug the monopolar device (e.g. PenEvac), into the
Monopolar port of the ESU Generator.
5. Select the “Monopolar” option on ESU Generator.
6. Set ESU Generator’s Cut and Coag value.
7. Activate the monopolar device by depressing cut or coag
button. When the monopolar device activates, the RF
Sensor should turn ON the Crystal Vision Smoke
Evacuator, automatically.
UNIVERSAL BLUE™ RF Sensor when used with
Bipolar Devices
(Figure 3; Option 1; Placement 1 or 2):
1. Plug the UNIVERSAL BLUE™ RF Sensor’s connector
into Crystal Vision Smoke Evacuator’s ESU/Laser port.
2. Place the UNIVERSAL BLUE™ RF Sensor, on the
bipolar device’s cable, making sure the sensor is installed
on top of the cable, facing down, to prevent capture of
residual RF signal from surrounding devices.
3. Use both of the self-adhering Velcro straps to wrap
around the sensor and over the bipolar device’s cable, to
secure the cable to the sensor at both ends of the sensor.
4. Plug the bipolar device into the ESU Generator.
5. Select the “Bipolar” option on ESU Generator.
6. Activate the bipolar device. When the bipolar device
activates, the RF Sensor should turn ON the Crystal
Vision Smoke Evacuator, automatically.
Figure 3: UNIVERSAL BLUE RF Sensor installation
when used with an electrosurgical generator (ESU)

7
UNIVERSAL BLUE™ RF Sensor when used with
Harmonic Scalpel Generator
(Figure 4; Placement 1 or 2):
1. Plug the UNIVERSAL BLUE™ RF Sensor’s
connector into Crystal Vision Smoke Evacuator’s
ESU/Laser port.
2. Place the UNIVERSAL BLUE™ RF Sensor on the
hand piece cable, making sure the sensor is installed on
top of the cable, facing down, to prevent capture of
residual RF signal from surrounding devices.
3. Use both of the self-adhering Velcro straps to wrap
around the sensor and over the hand piece cable, to
secure the cable to the sensor at both ends of the sensor.
4. Plug the handpiece into the Harmonic Scalpel Generator.
5. Set the Harmonic Scalpel Generator
6. Activate the handpiece. When the handpiece is
activated, the UNIVERSAL BLUE™ RF Sensor
should turn ON the Crystal Vision Smoke Evacuator
automatically.
CAUTIONS: Use only smoke evacuator accessories
manufactured by I.C. Medical, Inc. as SAFEGUARD
BLUE
®
Hydrophobic ULPA Filter with Built-in Fluid Trap,
Large Coconut Charcoal Output Filter, RF Sensor(s), smoke
tubing disposable and other accessories. Using any other
filters, sensors, or accessory, not manufactured or supplied
by I.C. Medical, Inc. may cause damage and/or cause the
system to be inoperable and may void the warranty.
FOOT SWITCH
INSTALLATION/OPERATION
If you would like to use your Smoke Evacuator independent
to other devices, proceed with the following:
1.Plug the Foot Switch’s connector into the Smoke
Evacuator’s ESU/Laser port as per Figure 5.
2.Depress/Release Foot Switch to activate/deactivate the
Smoke Evacuator.
Figure 4: UNIVERSAL BLUE RF Sensor installation
when used with Harmonic Scalpel generator
Figure 5: Foot Switch Installation

8
LASER SENSOR INSTALLATION
If you are going to use your CRYSTAL VISION® with a
laser, proceed with the following:
1. Attach the Sensor Cable (Figure 6) to the LASER
connector on the CRYSTAL VISION® and to the
Sensor Connector Box.
2. 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:
a) Plug the Sensor Cable into the Sensor
Connector Box and the LASER connector of the
CRYSTAL VISION®.
b) Plug the CRYSTAL VISION® into an AC
outlet and turn on the Power Switch on the Control
Box back panel and front panel.
c) Align the Transmit Sensor Lens and the
Receive Sensor Lens until the red light goes off and
the CRYSTAL VISION® starts.
d) Move the Sensor until the red light comes on.
The pump in the CRYSTAL VISION
®
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 VISION
®
front panel).
3. Place the foot switch for the laser on an easily accessible
work surface (Figures 7 & 8).
4. Inside the foot switch housing (Figure 8), 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.
WITHOUT REMOVING THE PROTECTIVE
COVERING ON THE TAPE, position them so that the
red light comes on.
Figure 6: Laser Sensor Installation
Figure 7: Laser Sensor Installation to the SIDE of the
laser foot switch HOUSING.

9
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.
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.)
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.
Figure 8: Sensors should be positioned so that ANY
movement of the pedal interrupts the beam.
HOUSING
FOOT PEDAL
FOOT PEDAL
BEAM
BEAM
TRANSMITTER
OR
RECEIVER
(a) (b)

10
CHECK PROPER OPERATION OF
THE CRYSTAL VISION®
1. The CRYSTAL VISION
®
. power switch (Figure 9) is
located on the back panel, next to the power cord. Place
this in the "ON" [I] position. When unit is turned ON, the
FLOW SET, indicators and display for TIME and FLOW
should illuminate.
2. Adjust the TIME by pressing the push buttons (Figure 10)
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 10) 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 30 seconds. Press the MANUAL
button. The pump should start and then stop approximately
30 seconds after the button was released
5. 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.
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 9: ON/OFF power switch description.
Figure 10: Manual and Time Control locations.

11
6. The FLOW SETTING buttons (Up and Down arrows),
(Figure 11), adjusts the desired Flow level on the Flow
Setting display. The Flow Reading digital meter indicates
the actual Flow through the unit. Some RF noise may cause
the Flow Set and Flow Reading to flicker; however, it will
not affect the actual flow or the functionality of the
CRYSTAL VISION
®
.
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 SAFEGUARD BLUE
®
Hydrophobic ULPA Filter with Built-in Fluid 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.
10. For any problems, or if the CRYSTAL VISION® fails to
perform as indicated, contact I. C. Medical, Inc.
Figure 11: Flow buttons.

12
DESCRIPTION OF SWITCHES,
CONTROL BUTTONS &
INDICATORS
The Sensor Assembly and the Large Coconut Charcoal
Output Filter should already be installed according to the
INSTALLATION INSTRUCTIONS.
1. ON/OFF SWITCH is located on the back panel (Figure
12) next to the power cord. This switch controls the
power to the CRYSTAL VISION
®
. 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 13) used to turn the
CRYSTAL VISION
®
ON when the surgeon is not
activating a smoke-producing device. 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 13) 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 13) is the input for the
ESU SENSOR CABLE. This sensor can be used to
activate the CRYSTAL VISION®.
Figure 12: ON/OFF power switch location.
Figure 13: Manual button and sensor connectors.

13
5.
TIME SETTING Buttons (Up and Down arrows) (Figure
14) varies the amount of time that the CRYSTAL VISION
®
continues to draw smoke, vapor, and gases from the
surgical site. The low flows into the pneumoperitoneum
limit the amount of gas that can be evacuated from the
pneumoperitoneum without causing the abdomen to
deflate. 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.
TIME DISPLAY (METER) (Figure 14) indicates the
amount of time that the CRYSTAL VISION
®
will operate
after the foot switch, or hand switch, is deactivated (2 sec
min- 30 sec max)
6. OPEN and LAP buttons (Figure 15) select 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 14: Adjustment for time setting.
Figure 15: Setting the flow RANGE.