Use and Care Instructions

Transcription

1 Precision Surgical Instruments, Inc. Use and Care Instructions Rings Document UCI-RF Rev /2018

2 The Mastel line of rings offers an abundance of choices. Each ring type has unique features and sizes to accommodate specific needs of the surgeon. All rings feature highly-tuned fixation teeth which provide superior fixation as well as a high degree of safety. Product Application The rings provide primary meridian marking based upon pre-operative corneal references and can perform as a scalpel guide ring (except the Osher/Nichamin model) for the following procedures: Astigmatic Keratotomy (AK) Corneal Relaxing Incisions (CRI) Limbal Relaxing Incisions (LRI) Peripheral Corneal Relaxing Incisions (PCRI) Toric Intraocular Lenses Surgical Use The ring is placed directly on the cornea. Typically the 0/180 reference is aligned with pre-operative horizontal cardinal reference marks (Figure 1). Figure 1. Align ring with horizontal pre-marks. 2 Use and Care Instructions Rings Product Number(s): See page 6

3 A Bores Two Ray (paired marks) or a Bahr or Wright Hook (single marks) is employed to mark the steep meridian. These become the reference points for performing AK or Toric lens alignment (Figure 2). Figure 2. Mark AK or Toric lens meridian (Gimbel/Mendez Ring and Bores Two-Ray shown). Jarvi/Olson models do not have the full 360º engraving, but AK specific arc lengths. Example: An incision from 40 to 40 would be 40 degree arcuate as shown in Figure 3. Figure 3. Jarvi pattern for arcuate cuts (Gimbel/Mendez Ring with Jarvi pattern shown). The Olson Guide Ring simply has non-numerical marks at 90º and every ten degrees (Figure 4). Figure 4. Olson Guide Ring. Use and Care Instructions Rings 3 Product Number(s): See page 6.

4 All beveled rings (excluding the Osher/Nichamin model) provide additional functionality by acting as a guide ring for making arcuate incisions with Mastel scalpels. When placing the scalpel footplate on the beveled surface, one can create a more curvilinear arc. Additionally, the bevel helps maintain a more perpendicular relationship between the scalpel and corneal surface. When using beveled rings as guides, always place the diamond centrally with footplate against the ring, as shown in Figure 5. Figure 5. Using ring as a scalpel guide. Diamond is pointed centrally and footplate glides along the ring. Additional Product Information: Your ring comes from one of these bevel/body styles (except the Olson model). Bakewell/Olson Fixation and Guide Ring 9.75 mm ID mm OD mm ID mm OD Gimbel/Mendez Fixation and Guide Ring mm ID mm OD Osher/Nichamin Fixation Only mm ID mm OD Cionni Fixation and Guide Ring mm ID mm OD 4 Use and Care Instructions Rings Product Number(s): See page 6

5 Handle location can be at 0/180º or 90º on all models. Handle location can be at 0/180º, 90º or 135º on Gimbel/Mendez and Osher/Nichamin models. 0/180º is typically preferred if holding ring temporally. 90º typically preferred if holding inferior. The 135º handle location provides an inferior offset placement. Use and Care Instructions Rings 5 Product Number(s): See page 6.

6 Product Numbers Product Number Description RFBC RING - FIXATION, MM, FIXED BORES RFTC RING - FIXATION, MM, FIXED THORNTON RSBC RING - FIXATION, MM, SWIVEL, BORES RSTC RING - FIXATION, MM, SWIVEL, THORNTON RSBC RING - FIXATION, MM, SWIVEL, BORES RSTC RING - FIXATION, MM, SWIVEL, THORNTON RFBO NF1400 RING - FIXATION, FTR MM, FIXED BORES RFTO NF1400 RING - FIXATION, FTR MM, FIXED THORNTON RFBO NF1475 RING - FIXATION, FTR MM, FIXED BORES RFTO NF1475 RING - FIXATION, FTR MM, FIXED THORNTON RSBO NF1400 RING - FIXATION, FTR MM, SWIVEL, BORES RSTO NF1400 RING - FIXATION, FTR MM, SWIVEL, THORNTON RSBO NF1475 RING - FIXATION, FTR MM, SWIVEL, BORES RSTO NF1475 RING - FIXATION, FTR MM, SWIVEL, THORNTON RFBG MG1116 GIMBEL MENDEZ RING (90 ) BORES (11.75X16.00) RFTG MG1116 GIMBEL MENDEZ RING (90 ) THORNTON (11.75X16.00) RFBG KM1116 GIMBEL MENDEZ RING (KOCH 135 VERSION), BORES (11.75X16.00) RFTG KM1116 GIMBEL MENDEZ RING (KOCH 135 VERSION), THORNTON (11.75X16.00) RFBG GM1116 GIMBEL MENDEZ RING, (0/180 ) BORES (11.75X16.00) RFTG GM1116 GIMBEL MENDEZ RING, (0/180 ) THORNTON (11.75X16.00) RFBG CR1216C 0 GUIDE RING CIONNI BORES, Febbraro (0/180) RFTG CR1216C 9 GUIDE RING CIONNI THORTON 90, Febbraro (90) RFTG CR1216C 0 GUIDE RING CIONNI THORTON, Febbraro (0/180) RFBG JO1116 JARVI MENDEZ RING, BORES (11.75X16.00) RFTG JO1116 JARVI MENDEZ RING, THORNTON (11.75X1600) RFBG OG1215 OLSON GUIDE RING, BORES RFTG OG1215 OLSON GUIDE RING, THORNTON RFBM ON1215G OSHER/NICHAMIN, BORES (12.75X15.00) (0/180º) RFBM ON1215K OSHER/NICHAMIN, BORES (12.75X15.00) (135º) RFBM ON1215M OSHER/NICHAMIN, BORES (12.75X15.00) (90º) RFTM ON1215G OSHER/NICHAMIN, THORNTON (12.75X15.00) (0/180º) RFTM ON1215K OSHER/NICHAMIN, THORNTON (12.75X15.00) (135º) RFTM ON1215M OSHER/NICHAMIN, THORNTON (12.75X15.00) (90º) RFBM ON1215J OSHER/NICHAMINN, BORES (12.75X15.00) (JARVI) RFTM ON1215J OSHER/NICHAMINN, THORNTON (12.75X15.00) (JARVI) 6 Use and Care Instructions Rings Product Number(s): See page 6

7 Use and Care After use, adequate cleaning is required to maintain the ring s continued proper function. As an intraoperative instrument, sterilization between cases is necessary. Mastel rings can be sterilized along with other surgical instruments. Standard cleaning and sterilization procedures apply. Sterilized products should be stored in a dry environment. Apart from this, no special conditions are necessary as far as storage is concerned. When reprocessing manually, care must be taken that no damage is caused by the use of metal brushes, scouring agents or by the exertion of too much force. Products must be stored appropriately during sterilization (not on top of each other and fixed in place with sterilization strips or sterilization plates). The use of distilled or deionized water for all reprocessing cycles (including pre-cleaning) is recommended because tap water can cause the concentrations of ions on the surface of the steels to increase. Sterilization instructions continued on Page 8. Use and Care Instructions Rings 7 Product Number(s): See page 6.

8 Sterilization The times and temperatures specified are minimum requirements. Should the user select other forms of sterilization, the user must validate these. The use of gravity displacement process must be approved by means of additional validation (longer sterilization times may be necessary). A steam sterilizer in accordance with DIN EN and DIN EN 285 and validated in accordance with DIN EN 554/ANSI AAMI ISO (valid selection and product-specific performance qualification) Maximum sterilization temperature 137 C (279 F) (plus tolerance range in accordance with DIN EN 554/ANSI AAMI ISO 11134) Drying times as recommended by the sterilizer manufacturer. Prevacuum high temperature steam sterilizer four minutes at 132 C/134 C (270 F/273 F), or twenty minutes at 121 C (250 F) wrapped Gravity displacement autoclave five minutes at 132 C / 134 C (270 F / 273 F), or twenty minutes at 121 C (250 F) unwrapped thirty minutes at 121 C (250 F) wrapped Statim steam sterilizer with radiant heat drying three and one half minutes at 135 C (275 F) for unwrapped, or ten minutes at 135 C (275 F) wrapped For official documentation on cleaning and sterilization, visit mastel.com/faq/ 8 Use and Care Instructions Rings Product Number(s): See page 6

9 Certifications and Licenses Mastel is CE listed and FDA registered. Certifications: ISO 13485:2003 EN ISO 13485:2012 Licenses: Health Canada Mastel and its team of craftsmen, engineers and service representatives strive to provide you with the very best in ophthalmic surgical instruments. Our products are delivered to you with pride. If for any reason you need further assistance, please call one of our service representatives. They will provide the help you seek. Thank You! Contact Us 2843 Samco Rd. Ste. A Rapid City, SD Main Toll Free Fax Use and Care Instructions Rings 9 Product Number(s): See page 6.