Mira CR4000 Quick start guide

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OPHTHALMIC CRYOUNIT

CR4000

OPERATIONAL

INSTRUCTION

MANUAL

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Mira, Inc.*414 Quaker Highway * Uxbridge, MA 01569 * Tel: 508-278-7877 * 800 847-6472 * Fax: 508-278-4555 p.

Table of Contents

Section Description Page

1.0 Introduction 3

2.0 System Components 3

2.1 BaseSystem 3

2.2 Accessories 3

3.0 General Component Descriptions 4

3.1 Console 4

3.1.1 FrontPanel 4

3.1.2 RearPanel 4

3.2 60" High Pressure Hose (CR4260) 5

3.3 Gas Cylinder Connector (CR43xx) 5

3.4 Micro-fiber Filter Assembly/Sintered Metal Filter Assembly 5

3.5 Microfiber Filter Element and O-Ring replacement procedure 6

3.6 25ft Scavenger Hose (CR4160){ 6

3.7 Cryo Equipment Carrier Single/Dual Cylinder capacity (CR4150) 7

3.8 CR4000 Instructional Video (CR40x) 8

3.9 Ophthalmic Probes 8

4.0 Initial Set Up Procedure 8

5.0 Foot Switch Operation 8

6.0 Test Procedure 9

7.0 Pressure Reduction Regulators 11

8.0 Probe Care 11

8.1Use 11

8.2Cleaning 11

8.3Storage 11

8.4Sterilization 11

9.0 Coolant Information 12

10.0 Safety Information 12

10.1 SafetyFeatures 12

10.2 GeneralSafetyPrecautions 13

11.0 Shipping Information 14

12.0 Product Specifications 14

13.0 Warranty Information 15

14.0 Certificate of Conformance 15

Figures and Tables

FIG. 1 Front and Rear Panels 5

FIG. 2 CryoUnit Equipment Carrier – Dual Cylinder CR 4150 7

Table I Gas Cylinder Connectors 6

Table II Cryo probe Model Numbers 8

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1.0 INTRODUCTION

This manual should be reviewed with all personnel involved with CR4000 systems to insure proper and

safe use.

The MIRA CR4000 and the interchangeable probes were designed to meet the exacting and practical

needs of Ophthalmologists who perform Cryosurgery. The system rapidly freezes or defrosts probe tips

while the ergonomically designed handles remain warm. It is non-electric, can be used with medical

grade CO

or N

O (non-siphon cylinders) and has three pre-selected temperature settings. The unique

design of the MIRA Cryo probe isolates the gas expansion chamber at the very tip of the probe, thereby

assuring that freezing and defrosting the probe, thereby assuring that freezing and defrosting occurs only

at the target area. Tip-only freeze also eliminates the need for an insulating boot, which can obscure the

surgeon’s view

The MIRA CR4000 has a rapid freeze and defrost cycle available, providing greater control of

application time.

Temperature settings for both CO

and N

O allow for pre-selected tip temperatures.

The choices of temperatures are -65, -35 and -5 (+/-5deg.C) for CO

and -85, -55 and -25 (+/- 5 C) for

2.0 SYSTEM COMPONENTS

See section 3 for expanded descriptions. Contact your distributor or MIRA, Inc.

for more information.

2.1 Base system

The MIRA CR4000 Ophthalmic Cryo System includes the Console, the Footswitch pedal

and the following:

CR40xx -CR4000 instruction video (specify NTSC.,PAL or SECAM)

CR4160 -25ft scavenger hose for system exhaust

CR4260 -60in. high-pressure hose for gas input

CR43xx -12 gas cylinder connector (section 3.3)

CR4350 -12 Replacement filters and 6 "O" rings

2.2 Accessories

CR40xx -CR4000 instruction video (specify NTSC, PAL or SECAM)

CR4150 -Dual Cylinder Cryo Carrier with switch-over valve, fittings, hoses and --

-filter assembly

CR4270 -Protective Probe Tip Cap for CR40xx (specify probe type)

CR4360 -30in. pressure hose (3)

CR4400 -Micro-fiber Filter Assembly

CR5400 -Sintered metal filter pack (3 plus 1 washer)

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3.0 GENERAL COMPONENT DESCRIPTIONS

3.1 Console

3.1.1. Front Panel (See Fig. 1)

The front panel has an “ON/OFF” switch, a gas supply pressure gauge, a tip

temperature selector and a probe receptacle.

Probes are connected to the console when the jack end is completely inserted into

the receptacle.

The “ON/OFF” switch controls the flow of the gas supply coming into the console.

The pressure gauge indicates supply pressure and not pressure to the probe.

When the “ON/OFF” switch is in the “OFF” position, the gas pressure gauge will

indicate zero. In the “ON” position, the gauge indicator should be in the green zone

(680-900psi) in order to achieve maximum efficiency. When cylinder pressure falls into

the yellow zone (below 680 psi), the probe tip temperature may vary or be warmer than

indicated. This indicates that the cylinder needs to be re-filled or changed. When a

cylinder is heated above room temperature it may exceed maximum pressure 900psi

(red zone). In this situation allow the cylinder to equilibrate to room temperature

(Approx. 70°F) before using*..

The three position temperature selector controls the tip temperature and offers a

choice of the following temperatures:

-65°, -35°and -5°(+/- 5°C) for CO

-85°, -55°and -25°(+/- 5°C) for N

* CAUTION: Do not exceed the following pressures when filling non-siphon gas

cylinders.

: 850psi max @70°F N

O: 730psi max. @ 70°F

3.1.2RearPanel

(See Fig. 1)

The rear panel has a barbed hose fitting for the exhaust system, a threaded fitting for

gas input and protected hoses which connect the consoles inner pneumatics for the

foot switch actuator mechanisms.

The exhaust system is for removing Nitrous Oxide (N

O) or Carbon Dioxide (CO

)

from the treatment area. Connect one end of the supplied 25ft. scavenger hose to the

barbed fitting and the other end to an aspiration system or operating room scavenger

system The gas input is for Nitrous Oxide or Carbon Dioxide coming into the system

from the cylinder. It is a 7/16-20 threaded fitting designed for use with the supplied

high-presssurehose

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Figure 1: Front and Rear panels of the CR4000 Ophthalmic Cryo Console

3.2

60"HighPressureHose(CR4260)

Both ends of the high pressure hose have 5/8 in. Hex nuts and 7/16-20 female pipe threads.

Connect one end to the Cryo Console “gas input” on the rear panel and the other end to the

gas cylinder filter connector assembly.

3.3 Gas Cylinder Connectors (CR43xx)

N²O and CO²gas cylinders come in a variety of sizes and with different connector

standards. Refer to ”Table 1" for the gas cylinder connector that suits your application. If

you are unsure or have any questions, contact your distributor or MIRA Inc.

MIRA gas cylinder connectors come in a choice of two configurations:

Without Filter assembly: For use with Dual Cylinder Cryo Carriers that come with factory

installed sintered metal filters.

With a Micro-fiber or sintered metal Filter assembly attached: For use with basic CR4000

systems.

IMPORTANT: Micro-fiber or sintered metal filters on the gas line will reduce the

introduction of particulates into the system, therefore reducing the chance of malfunction.

3.4 Micro-fiber Filter Assembly/Sintered Metal Filter Assembly

A choice of the above filter systems is supplied with each system either separately; as part

of a gas cylinder connector assembly; or factory installed in a Cryo carrier. These filter

assemblies are critical elements of the MIRA ophthalmic Cryo CR4000 system. A leading

cause of malfunction is the presence of particulates in the system. These particulates

originate from the gas supply and must be filtered in order to achieve proper system

performance. Replacement Filters; Micro fiber (packs of 12) or Sintered Metal (packs of 3)

along with replacement O-Rings are supplied with each system. Replacement filter packs

are available from MIRA or your distributor.

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Microfiber Filter Assembly (Cont’d)

O-Rings are available from MIRA or your distributor (CR4350). The filter element

should be changed every 30 to 45 days depending on use.

3.5 Microfiber Filter Element and O-Ring replacement procedure (CR4350)

1. Turn the gas cylinder valve OFF

2. Depressurize the CR4000 system. Turn “ON/OFF’ switch to an in-between setting. Gas can

be heard escaping from the exhaust port.

3. Unscrew, with a wrench, the bottom cylinder of the Micro-fiber Filter Assembly.

4. Remove the micro fiber filter element by sliding it off the metal core.

5. Inspect the O-Ring and replace if needed.

6. Install a new Micro-fiber Filter element (every 30 to 45 days depending on use).

7. Screw the bottom cylinder back on hand tight, then tighten no more than 1/4 turn.

Optional; Run test procedures as described in section 6.0.

Sintered metal Filter element and O-Ring replacement procedure (CR5350)

Proceed as in items 1, 2 and 3 above

4.Removethefilterelement

5.Inspectthesealingringandreplaceunlessitshows signs of damage.

6.Installanewfilterelement.Withnormalusethis should last up to twelve months.

7.Screwfiltercoverbackinplaceandtightenbyhand. Use a wrench to tighten a further

¼turn

Optional; Run test procedures as described in section 6.0

3.6 25ft Scavenger Hose (CR4160)

Connect one end of the 25ft. Scavenger hose to the barbed fitting on the console back panel and

the other end to an aspiration system or equivalent. The hose is used to remove exhausted gas

from the treatment area.

TABLE 1

Gas Cylinder Connectors.

Model No; Description

CR4210 Hand-tight N

O connector for “C” 8in. Cylinder (CGA Thread)

CR4310 Hand-tight N

O connector/Filter for “C” 8in cylinder (CGA Thread)

CR4220 Hand-tight CO

connector for “C” 8in cylinder (CGA Thread)

CR4320 Hand-tight N

O connector/filter for “C” 8in cylinder (CGA Thread)

CR4250 Universal T-Yoke connector for “E” 4in cylinder (not available in US)

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TABLE 1

(cont’d.)

CR4280 T-Yoke assembly for “E” 4in. Cylinder N

CR4380 T-Yoke assembly with Micro filter for “E” 4in. Cylinder N

CR4290 T-Yoke assembly for “E” 4in. Cylinder CO

CR4390 T-Yoke assembly with Micro filter for “E” 4in. Cylinder CO

3.7 Cryo Equipment Carrier Single/Dual Cylinder capacity (CR4150)

The CR4150 is specially designed to hold one or two gas cylinder tanks and the CR4000

Ophthalmic Cryo console at a convenient working height. It is

ideal for use in an operating

room or office treatment area. Contact your distributor or MIRA for more information.

Fig 2

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3.8 CR4000 Instructional Video (CR40x)

The CR4000 system instruction video is available in several formats: CD, NTSC, SECAM or

PAL. A videotape or CD is supplied with each CR4000 system. The format received is customer

specified. The video contains an overview of the CR4000 system and is intended to complement

this manual. It can also be used as an instructional aid.

3.9 Ophthalmic Probes

All probe shafts and tips are stainless steel. Refer to Table II for a listing of the MIRA

Ophthalmic Cryo Probes. The gas expansion chamber is at the very tip of the probes,

thereby assuring that freezing and defrosting occurs only at the target area. Warm high-

pressure gas insulates the shaft during freezing and defrosting cycles eliminating the need

for and insulating boot while reducing the danger of freezing adjacent tissues. The

handles present an unobstructed view of the probe shaft and remain comfortable to the

hand during use.

TABLE II Probe Model Numbers

Model No; Description

TipDiameterIceBallSize

CR4010 Curved Retinal 2.8mm 3.5mm

CR4015 Straight Retinal 2.8mm 3.5mm

CR4022StraightCataract 2mm 3.0mm

CR4023 Curved Cataract

2mm 3.0mm

CR4025 Mini Curved Cataract 1.5mm 2.0mm

CR4030 Curved Glaucoma 3.5.mm 4.0mm

CR4040 Vitreous 1.5.mm 2.5mm

CR4045 Mini Straight Vitreous 1.5 mm 1.5mm

CR4075 Curved Hammerhead 2.8mm x 6mm long 4.5mm

CR4080 Curved Baby Hammerhead 1.5mm x 4mm long 2.5mm

CR4085 Gaydon ROP 2mm 3.0mm

CR4090 Abramson Retinoblastoma 1.5mm 2.0mm

CR3095LashkariTrichiasis 2.8mm 2.5mm

4.0 INITIAL SET-UP PROCEDURE

IMPORTANT: To be performed or double checked each time an element of the CR4000

system is added, changed or disassembled.

Obtain a non-siphon gas cylinder of N

O or CO

. The type of cylinder and gas selected will

determine the connector needed. See table 1 for a complete selection of gas cylinder connectors.

WARNING; Siphon gas cylinders will vent gas in a liquid state when the valve is opened. Do

not use siphon gas cylinders

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Be sure that the gas cylinder is properly secured to a rack or the MIRA Equipment Carrier. It is

important to prevent the cylinder from tipping over. If the cylinder was not stored critically, set

aside for 24 hours. If it is hot or cold due to storage conditions, set it aside for 24hrs to equilibrate

to room temperature.

Make sure that the “ON/OFF” valve on the front panel of the console is in the “OFF” position.

Connect one end of the high-pressure hose to the “gas input” on the back of the console and the

other end to the gas supply through the Micro-Filter Assembly. Tighten both the 5/8 hex nuts by

hand then tighten them using an appropriate wrench. Attach cylinder connector to the gas supply

cylinder per the appropriate procedure below.

For CGA connector;

a. Place the adaptor against the mating outlet of the cylinder valve.

b. Engage the quick-coupling nut and tighten by hand.

For T-Yoke connector;

a. To ensure a tight seal, use the washer supplied with the cylinder.

b. Place the T-Yoke connector over the cylinder stub valve.

c. Tighten the “T” handle by hand.

Connect one end of the 25ft. Scavenger hose to the rear panel fitting labeled “System Exhaust”

Connect the other end to an aspiration system or equivalent.

Note; Use of the scavenger hose will result in quieter operation of the CR4000.

Check to be sure that the “ON/OFF’ valve on the front panel of the Cryo console is in the “OFF”

position. Then, completely open the valve on top of the gas cylinder by turning it counter-

clockwise. When the cylinder valve is completely open, turn it back (clockwise) one quarter-

turn.

This prevents the cylinder valve freezing and locking in the open position.

Listen and look for leaks at either end of the high-pressure hose. An audible hiss or frost on a

fitting identifies a leak. A leak can be corrected by tightening the appropriate 5/8 nut(s) on the

high-pressure hose. Any leak in the system will adversely affect the system performance,

particularly freezing and defrosting.

5.0 FOOT-SWITCH OPERATION

The foot-switch has approximately 12ft. (3.66metres) of reach in any direction.

A hissing sound is present each time the foot-switch is depressed or released.

Depressing the foot-switch pedal at any compass point will instantly freeze the probe tip.

Releasing the foot-switch pedal will instantly defrost the probe tip.

A popping sound may be heard from the relief valve if the foot-switch is depressed within 30

seconds of its last release. This is normal. The purpose is to lower the exhaust pressure so that

freezing can take place.

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6.0 TEST PROCEDURE -

To be performed prior to patient treatment

6.1 Select an Ophthalmic Cryo Probe and unscrew the protective cap from the probe jack.

6.2 Inserttheprobejackallthewayintothereceptacle on the front panel.

IMPORTANT: When the probe is not in use, the protective cap should be kept on the

probe jack to prevent foreign matter and moisture from entering the probe system during

handling, cleaning and sterilizing. (See section 8.0).

6.3 PRECONDITION PROBES - To assure proper probe operation, gas must be purged

from the probes prior to their use. To properly purge gas from a probe, follow the

procedure below,

6.3.1. Set the front panel valve “ON/OFF” switch to “ON”

6.3.2. Verifythereisaminimumof680psigaugeofpressure. Check the pressure gauge

Indicator, it should be in the green zone. (680-900psi gauge)

6.3.3. Select the -25º C temperature setting for Nitrous Oxide (N

Select the -5º C temperature setting for Carbon Dioxide (CO2)

6.3.4. Depress the foot pedal for 10 seconds and then release.

6.3.5. Wait 60 seconds while the exhaust gas is escaping from the rear scavenger port.

IMPORTANT;

Mostofthepurgingoccursduringthelast30seconds of the purge

cycle.

6.3.6. Repeat steps 6.3.4.and 6.3.5.twice.This will remove internal condensation as well

as restore ambient temperature to the system.

6.3.7. Thesystemisnowreadyforuse.

Shouldyouwishtoperforman“iceball”test,proceed as follows;

Remove probe tip cap. Submerge the tip into a solution of sterile saline and

depress the foot pedal for 10seconds, keeping the tip in the solution. After

ten seconds, with the foot pedal depressed, remove the probe tip from the

solution. An ice ball of 1.5 to 2.5 mm larger than the diameter of the probe

tip should have been formed. Release the foot pedal. In about 4 seconds, the

ice ball should be free to move when tipping the probe.

6.4. To remove the probe, allow the gas to dissipate for approximately 60 seconds. This

relieves the gas pressure in the system. If the probe must be removed quickly, turn the

“ON/OFF” valve to “OFF” while depressing the foot-switch. This action depressurizes

the system instantly.

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