Iridex Cyclo G6 Manuale utente

IRIDEX Cyclo G6™Laser System

Operator Manual

IRIDEX Cyclo G6™Laser System Operator Manual

66294-EN Rev D 2018

IRIDEX, the IRIDEX logo, IRIS Medical, MicroPulse, and SmartKey are registered trademarks; CW-Pulse,

FiberCheck, FlexFiber, G-Probe, Cyclo G6, LongPulse, MilliPulse, PowerStep, are trademarks of IRIDEX

Corporation. All other trademarks are the property of their respective holders.

66294-EN Rev D

iii

Contents

1Introduction.............................................................................................................1

Compatible Delivery Devices.............................................................................................1

Pulse Types.........................................................................................................................2

References...........................................................................................................................4

Indication for Use ...............................................................................................................5

References...........................................................................................................................7

Warnings and Cautions.......................................................................................................8

IRIDEX Corporation Contact Information .........................................................................9

2Setup.......................................................................................................................10

Unpacking the System ......................................................................................................10

Choosing a Location.........................................................................................................11

Connecting the Components.............................................................................................11

3Operation...............................................................................................................13

Front Panel Controls.........................................................................................................13

Powering the Laser On and Off ........................................................................................13

Treating Patients...............................................................................................................14

Using the Laser System ....................................................................................................15

4Troubleshooting ....................................................................................................22

General Problems..............................................................................................................22

Error Messages .................................................................................................................23

5Maintenance..........................................................................................................25

Inspecting and Cleaning the Laser....................................................................................25

Inspecting and Cleaning the Footswitch...........................................................................25

Verifying the Power Calibration.......................................................................................25

6Safety and Compliance.........................................................................................28

Protection for the Physician..............................................................................................28

Protection for All Treatment Room Personnel..................................................................28

Safety Compliance............................................................................................................30

Labels................................................................................................................................31

Symbols (As Applicable)..................................................................................................33

Specifications....................................................................................................................35

7Wireless Footswitch and EMC ............................................................................36

Setting Up the Wireless Footswitch..................................................................................36

Testing the Batteries .........................................................................................................36

EMC Safety Information...................................................................................................37

EMC Requirements for Console and Accessories ............................................................38

66294-EN Rev D

Contents

66294-EN Rev D

Introduction 1

Introduction

The IRIDEX Cyclo G6™ Laser System is a semiconductor diode laser that delivers true continuous wave

infrared (810 nm) laser light for ophthalmic applications. Improper use of the laser system can result in adverse

effects. Follow the instructions for use described in this operator manual.

Compatible Delivery Devices

These IRIDEX Familiesof ProbeDelivery Devices are compatible with the Cyclo G6 laser system:

•MicroPulse® Family

–MicroPulse P3: A single-use, RFID, fiber-optic handheld delivery device that when used with the

Cyclo G6, transmits 810 nm MicroPulse laser energy transsclerally to the ciliary processes for the treatment

of glaucoma. The fiber-optic tip of the MicroPulse P3 is 600-μm diameters and protrudes 0.4 mm from the

handpiece which allows accurate positioning of the fiber-optic tip at 3 mm posterior to the limbus.

–The MicroPulse Family may also include additional probes.

•G-Probe™Family

–G-Probe: A single-use, RFID, fiber-optic handheld delivery device that when used with the Cyclo G6,

transmits continuous-wave infrared laser transsclerally to the ciliary processes for the treatment of

glaucoma. The fiber-optic tip of the G-Probe is 600-μm diameter and protrudes 0.7 mm from the

handpiece which allows accurate positioning of the fiber-optic tip at 1.2mm posterior to the limbus.

–G-Probe™ Illuminate: Identical to the G-Probe with the addition of transillumination.

Transillumination aids the physician in identifying the location of the ciliary processes.

–The G-Probe Family may also include additional probes.

NOTE: Refer to the appropriate delivery device “Instructions For Use” for indications for use,

contraindications, precautions, and adverse effects information.

Illumination Control and Light Regulation

The IRIDEX Cyclo G6 Laser System includes a white light illumination source for augmenting visualization of

target tissue during treatment. Compatible delivery devices, such as G-Probe Illuminate, contain illumination

fibers for carrying white light from the console to the distal tip of the device. The light source is a white (broad

spectrum) LED that is driven from 0 –5 mW; the power level (and therefore the amount of illumination) is

adjustable by the user via the touch screen interface on the console and remote control. Power to the white LED

is normally OFF; power ON is managed automatically by the console when a compatible connector is inserted

into the light source orifice. An optical microswitch in the light source orifice detects proximity of a compatible

connector and triggers the ON/OFF function of the illumination source.

2 IRIDEX Cyclo G6™Laser System Operator Manual

66294-EN Rev D

Pulse Types

Two pulse types are available: CW-Pulse™ and MicroPulse® mode.

CW-Pulse™

Laser emission is continuous during the entire timed exposure.

MicroPulse®

MicroPulse (P) is a laser delivery consisting of a group of microsecond bursts.

Duty Cycle%= P Duration × 100

P +

Duration P

Interval

P

Interval MicroPulse

Pulse Envelope

Duration

P

Duration

Pulse Envelope

Interval Time (ms)

Interval

Pulse Duration

Time (ms)

Power (W)

66294-EN Rev D

Introduction 3

MicroPulse® is typically used to administer subvisible threshold laser treatments to macular and perimacular

targets. When used here, the terms “subvisible”, “subvisible threshold” or “subthreshold” denote that the desired

endpoint is one in which treated tissue offers no ophthalmoscopically observable laser effects. Nevertheless,

studies using 810 nm lasers have confirmed that subvisible laser treatment strategies can be clinically effective

while inducing no changes discernible by slit lamp observation, fluorescein angiography (FA), fundus

autofluorescence (FAF), or at any time postoperatively.1,2

Tissues receiving subvisible MicroPulse® laser treatment show no such changes because:

•MicroPulse® laser delivery is being used instead of CW, and

•The total laser energy of such doses is only a percentage (often chosen by clinicians to be 20-70%) of that

energy needed to produce a visible endpoint.

Energy (J) is equal to [Laser Power (W)] × [Exposure Duration(s)] × [Duty Factor (%/100)]. Duty Factor is often

5% to 15% when using MicroPulse® mode, and is 100% when using CW mode. Clinicians have reported various

strategies to adjust these parameters relative to suprathreshold burns in order to achieve clinically effective

subvisible endpoints.1-4

Additional parameters to consider in any laser treatment protocol, and particularly during MicroPulse®, is

spacing between laser treatment spots, and the total number of treatment spots administered. Due to the limited

thermal spread of MicroPulse® exposures, subvisible treatments often call for the administration of a greater

number of treatment spots with denser spacing than that used for threshold laser grid treatments.4

4 IRIDEX Cyclo G6™Laser System Operator Manual

66294-EN Rev D

References

1. Sasoh M, Smiddy W: Diode Laser Endophotocoagulation. Retina 1995;15(5):388-393.

2. Akduman, L, Olk, RJ: Diode Laser (810 Nm) Versus Argon Green (514 Nm) Modified Grid Photocoagulation

for Diffuse Diabetic Macular Edema. Ophthalmology 1997;104(9):1433-41.

3. Ulbig MW, McHugh DA, Hamilton AM: Diode Laser Photocoagulation for Diabetic Macular Oedema.

Br J Ophthalmol 1995;79(4):318-21.

4. Luttrull JK, Sramek C, Palanker D, Spink CJ, Musch DC: Long-Term Safety, High-Resolution Imaging, and

Tissue Temperature Modeling of Subvisible Diode Micropulse Photocoagulation for Retinovascular Macular

Edema. Retina 2012;32(2):375-86.

5. Vujosevic S, Bottega E, Casciano M, Pilotto E, Convento E, Midena E: Microperimetry and Fundus

Autofluorescence in Diabetic Macular Edema: Subthreshold Micropulse Diode Laser Versus Modified Early

Treatment Diabetic Retinopathy Study Laser Photocoagulation. Retina 2010;30(6):908-916.

6. Agarwal HC, Poovali S, Sihota R, Dada T: Comparative Evaluation of Diode Laser Trabeculoplasty Vs.

Frequency Doubled Nd : YagLaser Trabeculoplastyin PrimaryOpenAngleGlaucoma.Eye2006;20(12):1352-6.

7. Chung PY, Schuman JS, Netland PA, Lloyd-Muhammad RA, Jacobs DS: Five-Year Results of a Randomized,

Prospective, Clinical Trial of Diode Vs Argon Laser Trabeculoplasty for Open-Angle Glaucoma.

Am J Ophthalmol 1998;126(2):185-90.

8. Panarelli, JF, Banitt, MR, Sidoti, PA: Transscleral Diode Laser Cyclophotocoagulation after Baerveldt

Glaucoma Implant Surgery. J Glaucoma 2012.

9. Wilensky, JT, Kammer, J: Long-Term Visual Outcome of Transscleral Laser Cyclotherapy in Eyes with

Ambulatory Vision. Ophthalmology 2004;111(7):1389-92.

10. Schlote T, Derse M, Rassmann K, Nicaeus T, Dietz K, Thiel HJ: Efficacy and Safety of Contact Transscleral

Diode Laser Cyclophotocoagulation for Advanced Glaucoma. J Glaucoma 2001;10(4):294-301.

11. Haller JA, Blair N, de Juan E Jr, De Bustros S, Goldberg MF, Muldoon T, Packo K, Resnick K, Rosen R,

Shapiro M, Smiddy W, Walsh J: Transscleral Diode Laser Retinopexy in Retinal Detachment Surgery: Results

of a Multicenter Trial. Retina 1998;18(5):399-404.

12. Kapran Z, Uyar OM, Bilgin BA, Kaya V, Cilsim S, Eltutar K: Diode Laser Transscleral Retinopexy in

Rhegmatogenous Retinal Detachment Surgery. Eur J Ophthalmol 2001;11(4):356-60.

13. Odergren, A, Algvere, PV, Seregard, S, Kvanta, A: A Prospective Randomised Study on Low-Dose

Transpupillary Thermotherapy Versus Photodynamic Therapy for Neovascular Age-Related Macular

Degeneration. Br J Ophthalmol 2008;92(6):757-61.

14. Sharma, T, Krishnan, T, Gopal, L, Nagpal, A, Khetan, V, Rishi, P: Transpupillary Thermotherapy for

Circumscribed Choroidal Hemangioma: Clinical Profile and Treatment Outcome. Ophthalmic Surg Lasers

Imaging 2011;42(5):360-8.

15. Shields CL, Shields JA, Perez N,SinghAD, Cater J: PrimaryTranspupillaryThermotherapyforSmallChoroidal

Melanoma in 256 Consecutive Cases: Outcomes and Limitations. Ophthalmology 2002;109(2):225-34.

16. Banach, MJ, Berinstein, DM: Laser Therapy for Retinopathy of Prematurity. Curr Opin Ophthalmol

2001;12(3):164-70.

17. Axer-Siegel, R, Snir, M, Cotlear, D, Maayan, A, Frilling, R, Rosenbaltt, I, Weinberger, D, Kremer, I, Sirota, L:

Diode Laser Treatment of Posterior Retinopathy of Prematurity. Br J Ophthalmol 2000;84(12):1383-6.

18. Manayath, GJ, Narendran, V, Arora, S, Morris, RJ, Saravanan, VR, Shah, PK: Graded Subthreshold

Transpupillary Thermotherapy for Chronic Central Serous Chorioretinopathy. Ophthalmic Surg Lasers

Imaging 2012;43(4):284-90.

19. Chen SN, Hwang JF, Tseng LF, Lin CJ: Subthreshold Diode Micropulse Photocoagulation for the Treatment

of Chronic Central Serous Chorioretinopathy with Juxtafoveal Leakage. Ophthalmology2008;115(12):2229-34.

20. LanzettaP,Furlan F, MorganteL,Veritti D, Bandello F: NonvisibleSubthresholdMicropulse Diode Laser(810

Nm) Treatment of Central Serous Chorioretinopathy. A Pilot Study. Eur J Ophthalmol 2008;18(6):934-40.

21. Koss MJ, Beger I, Koch FH: Subthreshold Diode Laser Micropulse Photocoagulation Versus Intravitreal

Injectionsof Bevacizumab in the Treatment of Central Serous Chorioretinopathy. Eye (Lond) 2012;26(2):307-14.

22. Parodi MB, Spasse S, Iacono P, Di Stefano G, Canziani T, Ravalico G: Subthreshold Grid Laser Treatment of

Macular Edema Secondary to Branch Retinal Vein Occlusion with Micropulse Infrared (810 Nanometer) Diode

Laser. Ophthalmology 2006;113(12):2237-42.

66294-EN Rev D

Introduction 5

Indication for Use

This section provides information on the use of the laser in clinical specialties. Information is provided by

specialty and includes procedural recommendations along with specific indications and contraindications. This

information is not intended to be all-inclusive and is not intended to replace surgeon training or experience. The

regulatory information provided is applicable only in the United States. If the laser is used for indications not

included herein, the user will be subject to 21 CFR Part 812, the Food and Drug Administration’s Investigational

Device Exemption (IDE) regulations. For information regarding the regulatory status of indications other than

those listed in this manual, contact IRIDEX Regulatory Affairs.

IRIDEX does not make recommendations regarding the practice of medicine. References in literature are

provided as a guide. Individual treatment should be based on clinical training, clinical observation of laser tissue

interaction, and appropriate clinical endpoints.

Indication for Use

The Family of IRIDEX IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm],

IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces, delivery devices & accessories that are

used with them to deliver laser energy in either CW-pulse, MicroPulse® or LongPulse™ mode. Intended for soft

and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel

hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and

ophthalmology as follows:

810nm (The IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe, G-Probe Illuminate, &

MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (μP) treatment mode

and indicated for the treatment of Glaucoma:

DELIVERY

DEVICE

Condition

(Indicated for)

Treatment

(Intended Use)

CW/μP

MicroPulse® P3

Device

For the treatment of Glaucoma

including:

•Primary Open-Angle

•Closed-Angle

•Refractory

Transscleral cyclophotocoagulation

(TSCPC) of the ciliary processes

μP

G-Probe

G-Probe Illuminate

For the treatment of Glaucoma

including:

•Primary Open-Angle

•Closed-Angle

•Refractory

Transscleral cyclophotocoagulation

(TSCPC) of the ciliary processes

Procedural Recommendations

The user is directed to review the “Instructions For Use” for the compatible delivery devices prior to treatment.

6 IRIDEX Cyclo G6™Laser System Operator Manual

66294-EN Rev D

Contraindications

•Any situation where the target tissue cannot be adequately visualized or stabilized.

•Do not treat albino patients who have no pigmentation.

Potential Side Effects or Complications

•As with any surgical procedure, there is the potential risk of infection, inflammation, and post-operative pain.

Specific Warnings and Precautions

It is essential that the surgeon and attending staff be trained in all aspects of the use of this equipment. Surgeons

should obtain detailed instructions for proper use of this laser system before using it to perform any surgical

procedures. For additional Warnings and Cautions, see “Warnings and Cautions” in this chapter. For clinical

information, see “References” at the end of this manual. Proper eye protection must be utilized for the specific

treatment laser wavelength in use (810 nm).

Laser Settings

CAUTION: The following treatment parameters are those reported by physicians using IRIDEX products, or

like products, either in published literature or reported directly to IRIDEX. These treatment

parameters are presented as guidance ultimately it is the physician’s responsibility to determine

safe treatment parameters that will be used on patients on a case by case basis.

The laser energy is recommended to be administered via the probe optical fiber delivery handpiece which is used

intra-ocularly.

Beginning at low power with short duration exposures, the surgeon should note the surgical effect and increase

power, power density, or exposure duration until the desired surgical effect is obtained. The information in the

following tables is intended to provide guidance only for treatment settings, which are not prescriptive for any

condition. The operative needs of each patient should be individually evaluated based on the indication,

treatment location, and on the patient’s medical and wound healing history. If uncertain of expected clinical

response, always start with a conservative setting and increase the setting in small steps.

810 nm Typical Laser Treatment Parameters for Ocular Photocoagulation

810 nm Continuous-Wave*

Application

Delivery Device

Power

(mW)

Exposure

Duration (ms)

Treatment Application

Sites

Total Energy (J)

Transscleral

Cyclophotocoagulation

G-Probe™

1250-1500

3500 –4000

18-20

79-120

Transscleral

Cyclophotocoagulation

G-Probe™

Illuminate

1250-1500

3500 –4000

18-20

79-120

810 nm MicroPulse®**

Application

Delivery Device

Power

(mW)

Duty Cycle

(500 Hz)

Exposure Duration (ms)

Total Energy (J)

Transscleral

Cyclophotocoagulation

MicroPulse® P3

2000-2250

31.3%

50,000-180,000 Superior

50,000-180,000 Inferior

31-126

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