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The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer are indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

The unmodified device is Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer. Both are Goldman type tonometers to measure intraocular pressure to aid in the screening and diagnosis of glaucoma. In applanation tonometry the intraocular pressure (IOP) is calculated from the force required to flatten a constant area of the cornea. Goldmann tonometry is considered to be the gold standard test and is the most widely accepted method in current practice. The Keeler Tonomate is a flattening cone containing biprism that converts the circular image of the flattened cornea to two semicircles that touch and cross at the time of flattening the cornea. The force required to flatten the cornea is converted to millimeters of mercury (mmHg).

The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorized healthcare professionals

The Keeler Slit Lamp Z-series (modified device) exists in two variants: non-digital and digital. The Z-series variant of the product is introduced as a lower cost alternative of the H-series to meet expectations of the optometry market. The Keeler Slit Lamp Zseries includes bottom-illuminating tower assembly instead of top-illuminating Haagtype illuminating tower. The high percentage of components/assemblies used on cleared Keeler Slit Lamp H-series (unmodified device) will be utilized on the Z-series slit lamp. The modified device will come in a few different configurations assembled from the same components (022 Configurations of the Modified Device). High percentage of components shared between H-series and Z-series slit lamps are used on the cleared H-series device. Similar to the H-series slit lamp, the Z-series will offer a digital option for recording and storing images and a range of magnifications from x6 to x40. The Z-series slit lamp will only come with LED as a light source, the same as in cleared H-series device, but unlike the H-series slit lamp the bulb version will not be available for the Z-series. The modified device will offer converging and parallel viewing optics, the same options as available on the unmodified device.

The Keeler Slit Lamp is an AC-powered slit lamp bio-microscope and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorised healthcare professionals.

The Keeler Slit Lamp H-Series device is AC-powered slit lamp bio-microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. It is mounted on an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third party's table top {refraction unit} by suitably trained technicians. Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target. The patient is seated in front of the slit lamp with his/her chin in the adjustable chin rest and forehead against the forehead rest. With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. The digital option for the H-Series Slit Lamp enables digital photographs to be taken to capture the image being observed, for further viewing and record purposes. It comprises an additional USB camera module that can be fitted by the user between the binocular eyepiece assembly and the main body of the microscope, which is connected to a powered USB3 hub enclosed within the microscope base, for onward connection to a medically approved PC. Addition of this option necessitates modifications to the illumination tower to provide background lighting via a fibre optic light tube when capturing digital images. There are two variants of the H-Series Digital Slit lamp. The first variant uses an incandescent light source, which is used to illuminate the eye during examination and provide background illumination to aid digital photography. The bulb is more powerful than the bulb sited in the predicate 510(k) [K131589] due to the requirement for additional background illumination for digital photography. The quantity of light for illuminating the eye is comparable to the product sited in K131589, and therefore posses no additional risk to the safety and effectiveness of the product. The second product variant is an LED illumination option, which again provides light to illuminate the eye during examination and provides background illumination for digital photography. Both variants are factory fitted and comply with ISO 15004-2:2007.

The Keeler Kapture Software Package is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps

The Keeler Kapture software is an ophthalmic imaging system. The Kapture software package is intended to run on a PC and will allow the user to capture images from a digital slit lamp or other camera for review and storage. Images can have basic adjustments (such as colour, brightness and contrast) and images can be visually compared.

The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

The Digital Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is an active medical device, powered by a single AA battery. The operation principal is based on Goldmann applanation method.