Страна: Беларусь
Язык: русский
Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
IRIDEX Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
IRIDEX Corporation
2023-03-01
P/N: 14979 Rev E 06.2022 1 ENGLISH INSTRUCTIONS FOR USE INDICATIONS: This product, when used with an Iridex infrared laser, is indicated for transscleral cyclophotocoagulation (TSCPC) of the ciliary processes using CW-Pulse, MicroPulse ® , and/or LongPulse™. DIRECTIONS FOR USE: Remove probe from package and unwind with care. This product contains a glass optical fiber that can be damaged with improper handling. Connect probe to a compatible Iridex laser console. Consult your operator manual for additional instructions, contraindications, warnings, and cautions. Anesthesia Administer local anesthetic block: Retrobulbar and/or peribulbar injections, or subconjunctival anesthesia with, for example, 2% mepivacaine, or equivalent agent. Treatment may be done with patient supine or seated at the slit lamp. G-Probe and Eye Moistness Keep the G-Probe tip and the eye surface moist throughout TSCPC. Apply a drop of methylcellulose solution to the G-Probe device’s fiber optic tip, or close the patient’s eyelids to ensure moisturizing with the natural tear film. If you use a lid speculum, apply artificial tears to the eye; repeat topical lubricant method of choice after every four laser applications. Placement (Fig. 1) Hold the G-Probe parallel to the visual axis with the shorter edge of the footplate firmly between the anterior border and the middle of the limbus. Laser delivery is transscleral. Fig.1: Placement Applications (Fig. 2) Successive applications are spaced one- half the width of the G-Probe footplate apart by aligning a side of the probe over the indented center of the adjacent application. Fig. 2: Applications Treatment (Fig. 3) Administer 18-21 laser applications per treatment session over 270° (three quadrants, six or seven applications per quadrant), usually omitting the temporal quadrant. Fig. 3: Treatment G-Probe treatment parameters are suggested by Iridex and are based on recommendations by experienced clinicians (Table 1). Ultimately, it is the physician’s responsibility to determine appropr Прочитать полный документ