White Paper Tonosafe - 7 Pages

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Catalogue excerpts

White Paper Compliance of Tonosafe® disposable prisms for Goldmann Applanation Tonometry (GAT) with the relevant ISO Norm and with Haag-Streit internal quality standards. Author: Ulrich Nachbauer Company: Haag-Streit International Section: Product Management Core Products Date: March 2012 Version: 1.0 Abstract: Tonosafe® was tested by Haag-Streit and is recommended for use with all Haag-Streit Goldmann and Perkins applanation tonometers. The parameters correlate closely to the HAAG-STREIT quality standard and meet the ISO 8612 standard. The optical and mechanical quality of Tonosafe® is acceptable but not as good as the Haag-Streit reusable prism. An angle scale on the prism holder would significantly facilitate the horizontal adjustment and the angular IOP measurement on astigmatic corneas. HAAG-STREIT AG P.O. Box, Gartenstadtstrasse 10, 3098 Koeniz, Switzerland Phone: +41 31 978 01 11, Fax: +41 31 978 02 81, E-mail: info@haag-streit.com

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White Paper Compliance of Tonosafe® Date: 30.03.2012 1 Purpose To assess the quality of Tonosafe® disposable prims according to ISO 8612 and Haag- Streit quality standards for reusable Goldmann measuring prisms. 2 Methods Tonosafe® (Haag-Streit UK, Harlow, UK) from two different LOT numbers (A27336 - 08 (1), B28702-12 (2)) has been tested internally with Haag-Streit standard test methods. The front surface flatness was measured by an accredited test laboratory using a HeNe-Laser at a wavelength of λ = 633nm. The interference fringes were recorded on video and analyzed with computer systems. The...

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White Paper Compliance of Tonosafe® Date: 30.03.2012 casting poorly finished. dents). Outer edge smoothed. Holder (prism body) Nicely and smoothly finished. Finish OK but sometimes Angle scale (0–180°). fringed edges. No angle scale. Flatness front surface n = 30 n = 10 Mean peak to Mean peak to valley Mean P-V = 0.33 Mean P-V = 1.07 valley deviation deviation (P-V) (µm) Min/Max P-V = 0.12 / 0.46 Min/Max P-V = 0.7 / 1.6 over a central and min/max P-V over area of min. 4 mm a central area of 4 mm P-V < 3.0 Figure 1: Image quality of applanation semicircles during IOP measuring Haag-Streit reusable...

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White Paper Compliance of Tonosafe® Date: 30.03.2012 Haag-Streit reusable prism 4 4.1 Discussion Tonosafe Tonosafe® is designed as a disposable prism to eliminate the risk of cross infection. Tonosafe® is precision moulded and is intended for use with Goldmann and Perkins applanation tonometers. It fits to the workflow in daily clinical practice and avoids the necessity of cleaning and disinfecting of reusable applanation measuring prism [3]. Before each IOP measurement a prism, which is packed in a blister, must be placed precisely on the prism holder. 4.2 Haag-Streit reusable measuring prisms...

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White Paper Compliance of Tonosafe® Date: 30.03.2012 4.3.1 Tolerance of the weight The tolerance of the weight is defined by the reverse span, which means the change of force required to move the tonometer head of a calibrated tonometer in the opposite direction. Both Tonosafe® and Haag-Streit reusable prisms meet the ISO 8612 standard. 4.3.2 Diameter of the applanation circle The diameter of the applanation circle is critical, as during the IOP measurement, a diameter of 3.06 mm is to be applanated. On the Haag-Streit measuring prims, the diameter of the applanation circle is precisely controlled...

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White Paper Compliance of Tonosafe® Date: 30.03.2012 References [1] Eye (Lond). 2011 May;25(5):651-6. Epub 2011 Apr 1. Reliability of tonosafe disposable tonometer prisms: clinical implications from the Veterans Affairs Boston Healthcare System Quality Assurance Study. Thomas V, Daly MK, Cakiner-Egilmez T, Baker E. [2] Clin. Experiment Ophthalmol. 2004 Aug;32(4):364-7. Accuracy of the Tonosafe disposable tonometer head compared to the Goldmann tonometer alone. Kim P, Lertsumitkul S, Clark M, Gardner L, Macken P. [3] Eye (Lond). 2005 Jul;19(7):743-6. Use of disposable prism tonometry in routine...

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