CE-2000 Cryosurgical System

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CE-2000

™

A Low-Pressure, Non-Electric Fully Exhausted Cryosurgical System with Backlight Digital Temperature Display

Instructions for Use (English)

1

Table of Contents

Page

Identification/Specifications Illustrations: Front View (Figure 1), Rear View (Figure 2) ... 3

Introduction ... 4 Caution Statements ... 4 Information Statements ... 4 Unpacking/Set-up ... 4 Unpacking ... 4 Set-up ... 4 Installation of the Nitrous Oxide Cylinders ... 5 Installation of the Console ... 5 Checking the System ... 5 Gas Exhaust ... 5 Installation of Probes ... 5 Installation of Thermocouple Probes ... 5 Digital Temperature Display with Backlight ... 5 Operation of System ... 6 To Exchange Probes ... 6 To Exchange Cylinders ... 6 Shut Down ... 6 Care and Maintenance... 6 Cleaning ... 6 Probe Sterilization ... 6 Storage ... 6 Troubleshooting ... 7 User Information ... 8 Cryosurgical Probes... 9 Ophthalmology Probes ... 9 Pediatric Retinal ... 9 Trichiasis ... 9 Probe Sterilization ... 10 Cartridge Replacement ... 10 Warranty ... 11 Explanation of Symbols ... 12

2

Identification 22 14 7 8

6 5

9 10

4

15

13 12

21 17

16 11

18

19

3

23

2 1

Figure 1

Figure 2

Front View

Rear View

1. 2. 3. 4. 5. 6.

Foot Pedal Locking Casters Mobile Equipment Carrier Utility Drawer CE-2000™ Console Digital Temperature Indicator with Backlight (+75 ºC to -150 ºC) 7. Regulated Pressure Gauge 8. Probe Jack and Dust Cap 9. Probe 10. Probe Exhaust Connector Tube and Dust Cap

11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23.

Cylinder Yokes (2) System Exhaust Connector Foot Pedal Connection Pressure Regulator Control ON/OFF Control Identification Plate Cylinder Pressure Gauge (0-1000 psi) [0-70 kg/cm2] 30 in. (76.2 cm) Delivery Line Cylinder Retainer Straps Rear Exhaust Tube (not shown) Backlight Toggle Switch Battery Compartment: Two 9-volt Batteries Required Molding Trim

Specifications CE-2000 Console

Mobile Equipment Carrier

Size: 7 in. (17.8 cm) high, 12 in. (30.5 cm) wide, 11 in. (27.9 cm) deep Weight: 10.5 pounds (4.8 kg)

Size:

40.5 in. (102.9 cm) high, wide 19.5 in. (49.5 cm) wide 25 in. (63.5 cm) deep (with wheels)

Table Top:

19.5 in. (49.5 cm) wide 16.5 in. (41.9 cm) deep 58 pounds (26.3 kg)

Console Regulated Pressure: 400-625 psi (28-44 kg/cm2) Nitrous Oxide Gas Operated Weight:

Type “E” Nitrous Oxide Cylinders (2 required), or 20 pounds (9.1 Kg) Nitrous Oxide cylinder (2 required) NOTE: To convert psi to Kg/cm2 multiply by 0.07

3

Introduction The Frigitronics® CE-2000TM is a completely non-electric, (Battery Operated Display) low-pressure, fully exhausted cryosurgical system that uses readily available nitrous oxide gas.

Rapid freezing of the probe tip is started by depressing the foot pedal. Release of the foot pedal causes warm low pressure gas to flow through the probe for defrosting. The backlight display activates automatically when the foot pedal is depressed.

INDICATIONS FOR USE: The CE-2000 CryoSurgery System is designed to perform procedures in Ophthalmology, as well as Otolaryngology, Gynecology and Proctology. It is intended to destroy tissue during surgical procedures by applying extreme cold. The system provides controlled freezing temperature down to a maximum of -89 ºC. The complete CE-2000 Cryosurgical System consists of a control console with foot pedal, mobile equipment carrier, nitrous oxide cylinders and cryosurgical probes. The system operates on the Joule-Thomson principle where pressurized gas expands through a fine orifice, producing a rapid drop in temperature.

An automatic shut-off built into the system will stop the flow of nitrous oxide gas and will shut off the backlight and display approximately 4 minutes after the probe has been set aside. The system can be reactivated by simply depressing the foot pedal. A wide range of probes are available for use with the CE-2000 and are outlined on page 9.

Caution Statements any way. The hand-piece probe socket is intended to fit CooperSurgical probes. No others should be substituted. There are a number of probe tip configurations. It is highly recommended that the user consider the intended application and select from the options to achieve the desired outcome. Always ensure that the safety latch is engaged when inserting the probe plug into the probe jack on the front of the unit. Use CSI part number 20566 Front Exhaust Tube only for connection to probe. The foot pedal must be released to allow the tip to defrost before removing from tissue. The manufacturer has validated sterilization parameters. However, it is recommended that the user validate specific conditions under local protocol.

Rx ONLY: CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. Only health care professionals trained in use of Cryosurgical technique in the medical application in the field of Ophthalmology, Gynecology, Otorhinolaryngology and Proctology should use this device. Use only MEDICAL GRADE Nitrous Oxide in this Device. This device is supplied with indexed cylinder connectors specifically designed to prevent inadvertent use with other gases. This device is designed and shipped with cylinder fittings and yokes specified for Nitrous Oxide. Use of this device results in Nitrous Oxide gas exhaust, which must be properly vented. Do not restrict or limit the flow of gas in

Information Statements specifications far exceeding normal operating conditions. The equipment contains two 9-volt batteries. There is no EMI interference, certified to IEC60601-1-2:2001. The patient contact material is coin silver. Silver has been used successfully in medical devices for many years, and is a proven anti-microbial agent. The CE-2000 is Latex-Free.

This device operates by achieving rapid frost/defrost without directly exposing the surgeon or the surgical team to electrical or high pressure. It is recommended that the user pre-pressure test the device, prior to patient contact. The control console is equipped with a pressure regulator that cannot exceed 625 psi (44 kg/cm2). The control console is equipped with a safety latch, which locks the probe tube in place. All probes are pressure tested to

Unpacking and Set-up Set-up 1. Unwrap foot pedal and affix the CE-2000 console (5) to top of carrier by aligning the four pads on bottom of console to the pads on the top of the carrier, pushing down firmly on top corners to secure console. 2. Install two 9-volt batteries for backlight display: one for display, and one for backlight.

Unpacking The CE-2000 console is packaged with the following items: console with attached foot pedal (boxed), a delivery line, a front and rear exhaust hose, and two 9-volt batteries. The mobile equipment carrier is packaged with four locking casters, mobile equipment frame with attached cylinder harness, and two cylinder handles (“E” cylinders only). Check all packing material for accessories and components. Please read this operation manual carefully before using the system.

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handles on cylinders. Replace washers with each cylinder change. DO NOT OPEN CYLINDERS AT THIS TIME. 2c. Gas Purifier Filter (optional) Filters are available on all N2O opthalmic systems. Filters improve freeze capability because unwanted oils, water and other N2O contaminants are removed from gas prior to delivery to probe tips. NOTE: Replace filters with each cylinder change or as required.

For set-up of the console without the mobile equipment carrier, place the console on a secure surface and proceed with cylinder installation. Installation of Nitrous Oxide Cylinders Medical Grade nitrous oxide cylinders are locally available worldwide. Consult your local yellow pages under: GasMedical or Welding Supplies. Be sure to specify medical grade nitrous oxide gas. The CE-2000 TM System is designed to utilize nitrous oxide gas. Each system is shipped with nitrous oxide cylinder yokes.

Installation of the Console 1. With cylinders turned off, connect the rear console delivery hose to cylinder pressure gauge (17) on rear of carrier. Tighten hose fitting with a 5/8 in. (1.59 cm) or adjustable wrench.

1.

Position both cylinders onto mobile carrier base and secure in place by fastening buckles. Tighten straps as required. 2a. 20 pound (9.1 kg) Cylinder Connection Height - 25 in. (63.5 cm); circumference - 24 in. (61 cm) per tank (20 pounds [9.1 kg] cap. N2O per cylinder). Inspect seal for cuts, tears, etc., and replace if required. Hand tighten yoke onto cylinder. If leak exists, use wrench to secure. 2b. “E” Cylinder Connection Place optional “E” cylinder (6 pounds [2.2 kg] cap. N2O per cylinder) yokes and washers over both cylinder valves, positioning yoke indexing pins in cylinder valve holes, and hand tighten yokes. Place

2.

Attach rear exhaust tube (20) to console. Remove probe jack dust cap. Connect desired probe to console by inserting probe end plug into probe jack (8). Insert the plug while holding console firmly. Ensure that safety latch on plug is locked into groove on jack by gently tugging on probe end. To scavenge the N2O gas, remove dust cap from probe exhaust on front of console and connect 6 in. (15.2 cm) front exhaust tube from probe to front of console (10).

Checking the System Gas Exhaust Nitrous oxide gas can be exhausted in the following manner: 1. 2. 3.

Installation of Thermocouple Probes Plug desired thermocouple probe into probe jack (8) on front of console, remove dust cap on front exhaust connector (10) and connect 6 in. (15.2 cm) probe exhaust tube to front exhaust connector. The digital probe tip temperature indicator (6) will indicate the temperature at the probe tip once the foot pedal is activated.

Vent directly outside, via exhaust tube (10). Vent into the room exhaust ventilation system that vents directly outside. Connect to a vacuum/suction system that vents outside.

Digital Temperature Display with Backlight The CE-2000 is equipped with a backlight digital temperature display which operates on two 9-volt batteries (rear panel); one specific to the display and one for the backlight. To activate the backlight for low light procedures, place the toggle switch, located on the rear of the unit, in the ON position.

Important: Do not run the vent tube overhead to prevent accidental restriction of the exhaust gas flow. DO NOT RESTRICT THE GAS FLOW IN ANY WAY. Minimum System Capacity, 40 L/min. Use only exhaust hoses provided by CooperSurgical. If the probe exhaust tubing begins to expand due to back pressure, immediately remove vent hose from the probe and, if possible, turn the system off. The exhaust line should return to normal. Clear hose of all restrictions, and check for proper assembly.

Both the digital temperature display and the backlight (toggle in ON position) will automatically activate when the foot pedal is depressed, provided the gas supply is ON and operational. An internal pressure switch activates the backlight display. The display and backlight will automatically turn off in approximately four minutes as the flow of gas is automatically shut off.

Installation of Probes A few precautions should be followed when using cryosurgical probes: The regulated pressure gauge needle should touch the silver stop.

“LO BAT” will display when the batteries for the temperature display should be replaced. Replace the battery for the backlight when it begins to dim. The battery for the display has a longer expected life than the backlight battery.

Do not constrict, kink, bend, lay objects on, or otherwise damage or restrict probe or exhaust lines. Do not block exhaust holes at end of probe line where the probe plugs into console.

No Calibration is Required. Display is calibrated at CooperSurgical. The temperature meter is for reference only.

Do not attempt to insert or remove probe at the probe jack when the CE-2000 console is pressurized.

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Operation of System 1.

With probe and front and rear exhaust tubes TM connected to the CE-2000 console and desired probe in place, open cylinder valves. Turn On/Off control “ON” and adjust the Pressure Control (14) to obtain desired operating pressure. The operating pressure range of this system is 400-625 psi (28-44 kg/cm2). Recommended probe settings are listed on page 9. To decrease a pressure setting, depress foot pedal several times while adjusting.

2.

3.

load. As pressure is increased, temperature decreases, thus producing a larger ice ball. Precool the probe tip by depressing the foot pedal for 10 seconds and then release pedal defrosting for several minutes. A defrosted probe applied to target area provides maximum adhesion. Apply probe tip to target area; depress foot pedal to freeze, release foot pedal to defrost.

NOTE: A flow of gas can be heard in the probe during the freeze and defrost cycles. This is normal in a functioning system. After probe sterilization and prior to use, allow the probe to cool down at least 20 minutes. Then depress the foot pedal for a few seconds and release to allow the warm defrost gas to purge any moisture from the probe.

To activate the backlight for low light procedures, place toggle switch on the rear panel in “ON” position. The size of the ice ball at the probe tip is dependent on the pressure of the nitrous oxide gas and the heat

To Exchange Probes 1. 2.

Turn the On/Off control (15) OFF. Depress the foot pedal (1) several times to relieve the nitrous oxide gas in console, prior to removing probe.

3.

Regulated pressure gauge needle should touch the silver stop. Remove probe and exchange.

3.

Regulated pressure gauge needle should touch the silver stop. Exchange cylinders.

4. 5.

Turn backlight toggle switch to OFF. Remove probe.

To Exchange Cylinders 1. 2.

Turn cylinder valves off (clockwise). Depress the foot pedal several times to relieve the nitrous oxide gas in console, prior to removing probe.

Shut Down 1. 2.

3.

Turn cylinder valves off (clockwise). Depress the foot pedal several times to relieve the nitrous oxide gas in console, until front pressure gauge needle should touch the silver stop. Turn On/Off control to OFF.

Care and Maintenance The CE-2000 should be handled with the care appropriate to any precision instrument. Avoid dropping or mishandling the system and probes. Periodically inspect the hoses, fittings and probes for any damage or wear. Other than maintaining an adequate supply of medical grade nitrous oxide gas and two 9-volt batteries for the backlight display, the system is essentially maintenance-free.

Probe Sterilization All CE-2000 probes and insulating sleeves/boots can be steamed (Pre-Vacuum and Gravity Dispacement) for convenient sterilization between cases. Where possible, removable sleeves/boots should be sterilized separately. The probes and sleeves/boots can also be sterilized by ethylene oxide gas (ETO). Probe should be allowed to cool down at least 20 minutes prior to use. After sterilization and prior to use, the probe should be run in the defrost mode for several minutes to ensure that any moisture in the probe is removed.

Cleaning The control console, mobile equipment carrier and other exposed parts of the system may be wiped with any mild soap solution that is commonly used to clean equipment in the operating room. All surfaces with the exception of the pressure and temperature display may be wiped with alcohol.

Storage Store nitrous oxide cylinders, CE-2000 System and probes indoors at room temperature, 60-75 °F (15.5-23.8 °C)

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Troubleshooting CE-2000TM Cryosurgical System Problem A Probe does not freeze properly

Cause 1 On/Off valve OFF. 2 Cylinder valves closed. 3 Cylinder pressure below 600 psi. 2 (42 kg/cm ) 4 Cylinders are cold.

Remedy 1 Turn valve ON. 2 Open valves. 3 Replace cylinders. 4 Allow to warm to room temperature (70 °F) [21 °C]. 5 Depress foot switch completely. 6 Adjust regulated pressure to proper setting. 7 Ensure that probe plug is fully engaged and locked in position. 8 Refer to section D.

5 Foot switch not depressed. 6 Regulated pressure too low. 7 Probe plug not properly engaged. 8 Probe tip temperature not recording on digital temperature display. 9 Leaks in serviceable areas.

10 Moisture in probe or probe not cooled after autoclaving. 11 Contaminated Nitrous Oxide Gas. 12 Console or probe malfunction. B

C

Probe does not defrost properly

Premature defrost

1 2

Crimped probe or exhaust line. Dirty filter in probe line plug.

3

3 1

Probe does not defrost during operation. Foot switch not fully depressed for freeze mode. Moisture in probe or probe not cooled after autoclaving. Contaminated Nitrous Oxide Gas. No display.

2

No backlight.

2

3

3

1

Probe in use does not contain a thermocouple. Knob is loose on the shaft.

Allow defrost gas to flow through the probe to purge. Replace cylinders. Turn gas ON, insert probe and activate foot pedal. Replace 9-volt battery. Turn toggle to ON position, turn gas on and insert probe. Activate foot pedal. Replace 9-volt battery. Check that probe is thermocouple type.

1

Tighten knob with allen wrench.

1

No lubricant.

1

1 2

D

E

F

Digital Temperature Display - no temperature or backlight

On/Off valve or pressure regulator knob does not operate properly Difficult to insert probe into probe socket/or leaks

9 Tighten fittings and replace washer in cylinder yoke or replace probe jack “O” ring (P/N 20440). 10 Allow defrost gas to flow through the probe to purge. 11 Replace cylinders. 12 Connect a second probe to console and test. 1 Check lines for restrictions. 2 Remove surface contaminates with a nylon brush and retest probe. 3 Immediately flood tip area with sterile saline solution to defrost and shut console off. 1 Depress foot switch completely. 2 3 1

Apply a small amount of lubricant, e.g., syringe lubricant, to the probe shank that is inserted into the console. Do not place lubricant on gold plug. Twist probe shank while inserting to lubricate “O” ring (P/N 20440). 2 “O” ring damaged. 2 Replace with new “O” ring (P/N 20440). G Exhaust hose slips off 1 Exhaust line restricted. 1 Check exhaust lines for restriction and console or probe correct. 2 External exhaust source restricted or 2 Check venting or suction system for not adjusted correctly. restrictions and correct adjustment. NOTE: If above corrective action does not rectify the problem please contact the CooperSurgical Service Department for assistance at 203-601-9818 or 800-444-8456.

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User Information Replacement Parts for the CE-2000TM Console Part Number

Description

Item # (illustrated on Page 3)

20370-3

30 in. (76.2 cm) Delivery Line

18

20566

Front Exhaust Tube 6 in. (15.2 cm)

10

32873

Rear Exhaust Tube 20 ft. (610 cm)

20

22333

ON/OFF Knob

15

34029

Regulator Knob

14

20440

”O” Ring Probe Jack

8

32874

Cap, Plug, Front Panel Exhaust

10

Replacement Parts for all Mobile Carriers Part Number

Description

Item # (illustrated on Page 3)

20398

Casters Braking

2

30646

Base, Legs

2

21705

Hedlok Fasteners

20364

Tank Handles, “E” Cylinder

11

30740

Molding, Trim

23

20371

Washer, Nylon, Pin Index Yoke

11

20917

Yoke, Pin Index, “E” Cylinder

11

10978 and 21836

20-pound (9.1 kg) Cylinder Yoke

Not Shown

21837

20-pound (9.1 kg) Cylinder Yoke Seal

Not Shown

51875

Pressure gauge

17

20370-3

30 in. (76.2 cm) Delivery Line (2 required)

18

Not Shown

NOTE: There are no user-serviceable parts contained in the console. The CE-2000 Cryosurgical System and cryoprobes should be returned to CooperSurgical for servicing.

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Cryosurgical Probes CooperSurgical, Inc. provides a wide range of Frigitronics® cryosurgical probes for use with the CE-2000 Each slender, well-balanced, lightweight probe offers you the versatility for performing a wide variety of procedures. All probes contain thermocouples for probe tip temperature reading, unless noted. Standard Part Number

Supercool Part Number

Probe Description

Shaft Length

Shaft Diameter

Tip Length

Tip Diameter

TM

System.

Recommended Setting**

Ophthalmology Probes 124

162

Retinal, Straight

38 mm

2.5 mm

---

2.5 mm

600 to 625 psi

125

161

Retinal, Curved

38 mm

2.5 mm

---

2.5 mm

600 to 625 psi

708-4

Retinal, Straight w/fiber optic illumination

40 mm

4.0 mm

---

3.2 mm

600 to 625 psi

708-5

Retinal, Curved w/fiber optic illumination

40 mm

4.0 mm

---

3.2 mm

600 to 625 psi

126

Cataract, Straight

27 mm

1.8 mm

1.0 mm

1.8 mm

500 to 625 psi

127

Cataract, Curved

27 mm

1.8 mm

1.0 mm

1.8 mm

500 to 625 psi

128

Micro, Straight

27 mm

1.0 mm

---

1.0 mm

500 to 625 psi

Glaucoma (165 curved)

38 mm

3.5 mm

1.5 mm

3.5 mm

450 to 625 psi

147

Micro, Curved

27 mm

1.0 mm

---

1.0 mm

450 to 625 psi

134*

Vitreous, Intraocular (20-gauge)

35 mm

0.89 mm

---

0.89 mm

450 to 625 psi

Retinal, Spherical

28 mm

2.1 mm

---

3.0 mm sphere

600 to 625 psi

130

164

139

163

143

Retinal, Curved Hammerhead

40 mm

2.5 mm

6.5 mm wide

3.5 mm

600 to 625 psi

144

Retinal, Straight Hammerhead

40 mm

2.5 mm

6.5 mm wide

3.5 mm

600 to 625 psi

142

Retinal, Posterior

38 mm

2.7 mm

---

2.7 mm

600 to 625 psi

165

Retinal and Glaucoma

38 mm

3.5 mm

---

3.5 mm

600 to 625 psi

166

Oversized Retinal, Straight

38 mm

3.2 mm

---

3.2 mm

600 to 625 psi

Oversized Retinal, Curved

38 mm

3.2 mm

---

3.2 mm

600 to 625 psi

228

167

Cryoanalgesia, 17-gauge Trocar Tip

100 mm

2.5 mm

1.5 mm

2.5 mm

600 to 625 psi

237

Cryoanalgesia, 19-gauge Round Tip

100 mm

1.0 mm

1.0 mm

1.0 mm

600 to 625 psi

238

Cryoanalgesia, 19-gauge Angle Tip

100 mm

1.0 mm

1.0 mm

1.0 mm

600 to 625 psi

239

Cryoanalgesia, 19-gauge Trocar Tip

100 mm

1.0 mm

1.0 mm

1.0 mm

600 to 625 psi

121

2.08 mm Pediatric Retinal Curved

27 mm

2.84 mm

1.0 mm

2.08 mm

450 to 625 psi

120

1.88 mm Pediatric Retinal Curved

26 mm

2.54 mm

1.0 mm

1.88 mm

450 to 625 psi

148*

4 mm Hammerhead

34 mm

1.5 mm

4.0 mm

1.5 mm

450 to 625 psi

123*

3 mm Disc Probe

35 mm

1.5 mm

3.0 mm

1.5 mm

450 to 625 psi

Pediatric Retinal

Trichiasis 171

18-gauge Cone Probe

19 mm

1.3 mm

---

---

450 to 625 psi

172

3 mm Multi-Lash

19 mm

2.8 mm

5.0 mm

2.7 mm

450 to 625 psi

173

6 mm Multi-Lash

19 mm

2.8 mm

5.0 mm

2.7 mm

450 to 625 psi

* No thermocouple 2 ** NOTE: To convert psi to Kg/cm multiply by 0.07

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Probe Sterilization A: Recommended sterilization procedures for CE-2000™ probes: The CE-2000 probes can be sterilized with steam (Pre-Vacuum and Gravity Displacement) or ethylene oxide gas (ETO) sterilization process. For convenience, most users sterilize their operating room instruments where possible. CooperSurgical, Inc., recommends: Gravity Displacement 270–275 °F (132–135 °C) • 10-15 minutes 250 °F (121 °C) • 15-30 minutes Dry Time: 10.0 minutes Pre-vacuum Cycles 270–275 °F (132 –135 °C) • 3-4 minutes Dry Time: 10.0 minutes

RECOMMENDED HOSPITAL ETHYLENE OXIDE CYCLE Temperature 124–131 °F (51–55 °C) 50% RH (pre-humidity) 60 minutes -0/+10 minutes

Pre-vacuum Gas Pressure Exposure Time Post Vacuum Aeration

24 in. Hg ± 2 in. Hg (610 mm Hg ± 51 mm Hg) 6-8 psig (650-660 mg/L EO) 4 hours minimum 24 in. Hg 2X ± 2 in. Hg (610 mm Hg 2X ± 51 mm Hg) 12 -0/+1 hours at 124-131 °F (51-55 °C)

NOTE: The particular EO cycle should be validated per the equipment manufacturer’s requirements. It is recommended that each institution employ procedures which include the use of biological indicators in order to determine the effectiveness of the ethylene oxide process. Prior to sterilization, all probes must be “wiped” clean of blood and contaminants (alcohol recommended). Do not immerse probe in any solution. The above cycles and conditions will vary. The actual degree of sterility is dependent on the equipment, maintenance of equipment, cycle and product to be sterilized. Again, the above recommendations match those cycles presently used successfully on our products in the field. Sleeve Sterilization  It is recommended that sleeves (used with retinal probes Numbers 124, 125, 126, 127, 128, 130, 134-142, 143, 144,147, 708-4, 708-5, 161, 162, 163, 164, 165, 166, 167, 171, 172, 173, 228, 237, 238 and 239) be removed and cleaned before sterilization. Sleeves may be sterilized using same technique (sterilization methods) and parameters as mentioned above for probes. Use (sterile) alcohol to lubricate sleeve before reapplying to probe.  Do not remove sleeves from Pediatric Probes Numbers 123 and 148. Sleeves may be removed from Pediatric Probes Numbers 120 and 121.  Spherical probe Number 139 may be sterilized with sleeve.

Cartridge Replacement Filter assembly for nitrous oxide and carbon dioxide gases. Removal of oils and water. 1. 2. 3. 4. 5.

Shut off the valve or valves at all supply cylinders. Bleed off the gas in the lines until the pressure gauge needle touches the silver stop. Unscrew the shell casing from the assembly. Unscrew the cartridge from the assembly and discard. Each cartridge is supplied in a hermetically sealed container. Open the container and remove new cartridge. NOTE: Do not remove purifier cartridge from hermetically sealed container until ready to install in purifier. 6. Screw the new cartridge into the assembly, and screw the shell casing into place. Ensure that the “O” ring seal is properly seated. If difficulty is encountered when installing the shell casing due to the “O” ring, replace worn “O” ring with new replacement. “O” rings may have to be replaced with each cylinder change.

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7. After all fittings are secured, open valves at the cylinders and check the filter assembly for leaks. 8. It is recommended that the filter be replaced with each cylinder change. Reorder No. P191

Replacement Cartridge (package of 6)

WARRANTY The CooperSurgical product is warrantied against defective material and workmanship (under normal use and application) for a period of one year from date of invoice. Under the Warranty, CooperSurgical’s sole obligation is to repair or replace, at CooperSurgical’s discretion, the product or defective part thereof. Lamps, bulbs, filters, batteries, etc, and other expendable items are not covered by this Warranty. This Warranty applies only to new products and does not apply to a product which has been tampered with or altered in any way; or has been misused or damaged by accident or negligence; or which has the serial number removed, altered or effaced; nor shall this Warranty extend to a product installed or operated in a manner not in accordance with the applicable instruction manual; nor to a product which has been serviced or repaired, other than by CooperSurgical. All claims under this Warranty must be directed to CooperSurgical, 95 Corporate Drive, Trumbull, CT 06611, (203) 601-5200. Returns for repair or replacement under Warranty shall be shipped to the Service Department at CooperSurgical, 95 Corporate Drive, Trumbull, CT 06611 - freight or postage prepaid. Repaired or replacement units shall be returned to the customer prepaid. In consideration of the foregoing promises by seller, buyer agrees that this Warranty is in lieu of all Warranties implied or expressed, and no representative or person is authorized or allowed to make any obligation for CooperSurgical not in accordance with the above. This product represents years of progress in the design and manufacture of precision instruments and equipment. Its quality has been rigidly safeguarded by exacting inspections throughout manufacture.

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Explanation of Symbols Reorder Number Serial Number Consult instructions for use

Caution

Not made with natural rubber latex

Product conforms to the Medical Device Directive 93/42/EEC Authorized Representative in the European Community

Rx Only

U.S. Federal law restricts this device to sale by or on the order of a physician. Manufacturer

Date of Manufacture

Do not use if package is damaged or opened

Frigitronics® is a registered trademark of CooperSurgical, Inc. CooperSurgical is a registered trademark of CooperSurgical, Inc. CE-2000TM is a trademark of CooperSurgical, Inc.

© 2016 CooperSurgical, Inc.

CooperSurgical 95 Corporate Drive Trumbull, CT 06611 USA

95 Corporate Drive • Trumbull, CT 06611 USA Phone: (800) 243-2974 • Fax: (800) 262-0105 www.coopersurgical.com

International Phone: (203) 601-9818 Fax: (203) 601-4747

34771-IFU • Rev. A • 2/16

EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands

Made in the USA

12

CooperSurgical 95 Corporate Drive Trumbull, CT 06611 USA

95 Corporate Drive • Trumbull, CT 06611 USA Phone: (800) 243-2974 • Fax: (800) 262-0105 www.coopersurgical.com

34771-IFU • Rev. A • 2/16

International Phone: (203) 601-9818 Fax: (203) 601-4747

EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands

Made in the USA