Use and Care Instructions. Bakewell BubbleLevel

Transcription

1 Precision Surgical Instruments, I nstruments, Inc. Use and Care Instructions Bakewell BubbleLevel UCI-MRMT BB Rev /2018

2 Product Application Used and maintained in the pre-operative area, the Bakewell BubbleLevel simplifies marking a true horizon. Pre-Operative Use Patient should be in an upright position, either on a gurney or in the lane. Approach the patient directly from the front, covering partner eye to avoid cross fixation (Figure 1). We recommend that all lidocaine jelly be removed before marking. As to not intimidate the patient, bring the marker in from the side (Figure 2). Once close to the eye, begin to level the bubble and align with the marking fins. Figure 1. Cover partner eye to prevent cross fixation. Figure 2. Bring the marker in from the side. Keep the patient focused on a distant point, centration light (such as the Mastel Zero Parallax Axis Glasses) or your (the practitioner's) eye (Figure 3). You can gauge centration by looking through the center of the marker. Figure 3. Patient is focused on a centration light. Apply gentle pressure to ensure marking. A gentle rocking motion can help once the marker is seated on the eye. Remove the marker from the eye by pulling straight away from the patient. Return the marker to its dedicated case for sterilization. The Bakewell BubbleLevel can be used with or without ink. When using without ink, hold on the eye for an additional amount of time. A five count is recommended. 2 Use and Care Instructions Bakewell Bubblelevel

3 Product Features Our newly designed Bakewell BubbleLevel was engineered to meet the needs of sterilization. The replaceable bubble levels are simple to remove and replace. As with our previous non-removable bubble version, the plastic bubble level will not survive the autoclave. Please be certain to remove the level from the marker prior to placing the instrument in your autoclave. You may reuse the same level as many times as it will hold securely in its channel. When the level fits loosely into its channel, we recommend using a new level. Each new marker is provided with three additional levels for your needs. Bubble levels are stocked and available at Mastel Precision. Please allow 3 to 5 business days to receive replacement levels. How to distinguish your marker as the new removable version from the previous, permanent version: The new removable version has only one noticeable difference the added center set screw on the bottom of the marker (provides a more secure mounting). Center set screw Figure 4. Old bubble level marker has no center screw. Figure 5. New bubble level marker has a center screw. To remove your level, gently apply a rolling pressure on the ends of the level with your forefinger and thumb. The level should come free with slight, but firm pressure. Be certain to avoid the marker fins with your hand when the bubble releases to avoid bending the 2-ray out of alignment. If the bubble does not remove easily, be absolutely certain that you have the latest version of our Bakewell BubbleLevel. If you are unsure, please contact our service department for assistance! Figure 6. Bubble level removal. Use and Care Instructions Bakewell Bubblelevel 3

4 Positioning your new bubble level is very important (Figures 7-9), as a misaligned level may appear skewed when viewed during marking. There are two alignment notches in the ridge of the saddle, assisting you as you position the level. Once certain that the level is centered properly, apply steady firm pressure to seat the level in the bottom of the channel. It is imperative the channel is clean to guarantee reliable, level performance. Be certain the level has seated completely in the bottom of its holder by looking for any unwanted space on either side of the level from the end view. Inspect the final alignment. A very small amount of error may cause confusion when aligning for marking with the patient. You may be tempted to compensate for this error while viewing at a distance from the handle orientation. Simply roll the level out, properly align and press back into position. Figures 7-9. Positioning bubble level. 4 Use and Care Instructions Bakewell Bubblelevel

5 Use and Care Mechanical sterilization between uses is recommended for the Bakewell BubbleLevel. We recommend sterilizing the marker in its own dedicated tray apart from other instruments. Remove the bubble level PRIOR to sterilization (Refer to Figures 7-9 and Figure 10). Figure 10. Bubble level must be removed before sterilization. Sterilization instructions continued on Page 6. Use and Care Instructions Bakewell Bubblelevel 5

6 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/ 6 Use and Care Instructions Bakewell Bubblelevel

7 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 Bakewell Bubblelevel 7