an objective approach to colposcopy Technical Specifications Open software application and start new session Enter patient details Prepare patient for colposcopy Examine cervix with colposcope Remove handset from docking station and fit single use EIS sensor Visual assessment of cervix for presence of HG-CIN Application of 3–5% acetic acid Confirm patient ID and cytology on handset Take EIS reading Was reading OK? YES Take EIS reading at next site Does CI indicate HG-CIN? Does ZedScan™ indicate HG-CIN? YES See & Treat or Biopsy suggested S&T Use ZedScan™ to identify best biopsy site? Select single point mode Take biopsy based on clinical judgement and local practice Identify best site for biopsy Take single biopsy Description Pack size ZedScan™ system 1 System Includes 1 x handset, 1 x docking station, 1 CD containing software application with 1 user licence, Instructions for use. Single use EIS sensor x 120 individually wrapped sensors 1 • Seamless integration into colposcopic practice Zilico Limited The MedTECH Centre • Rutherford House Pencroft Way • Manchester Science Park Manchester M15 6SZ t +44 (0)161 826 7840 • e [email protected] www.zilico.co.uk Colposcopy plays a significant role in the management of women with abnormal cervical cytology. The performance of colposcopy can however vary widely with reported sensitivity and specificity for the detection of HG-CIN ranging from 30    9% and 39    2% respectively. –9 –9 Colposcopy is a subjective procedure with clinical decisions on whether to offer treatment, return to routine surveillance or retain the patient for follow up formed on the ability to assess the extent of disease based on visual colposcopic indicators. However, as not all HG-CIN exhibits aceto-whitening and changes in acetowhiteness and vascularity are not specific to HG-CIN, inaccurate colposcopy can lead to inappropriate or over-treatment, diagnostic delays pending histological confirmation, or repeated colposcopic examination to avoid a missed diagnosis. ZedScan™ uses Electrical Impedence Spectroscopy (EIS) to identify and differentiate cervical tissue types according to their electrical properties. These properties are known to change during the development of neoplasia, with more dysplastic cells exhibiting a reduced resistance to the flow of current as a result of structural changes. ZedScan™ is a multi-component system comprising a portable handset, docking station, single use EIS sensor and analysis software. ZedScan™ is used as an adjunct to colposcopy, providing an objective assessment of cervical epithelial tissue and supporting better patient management by enabling clinicians to make a more informed decision at first visit. EIS spectra Key Squamous Immature metaplasia High grade CIN Columnar Objective assessment ZedScan™ surveys the cervix by taking EIS readings at multiple points around the transformation zone. Each reading is given a nominal value and characterized by comparison with a reference, providing a non-visual semi-quantitative, reproducible assessment of the epithelial tissue. • Non-visual diagnosis ZedScan™ Components • Rapid real-time results ZedScan™ consists of a portable hand-held device, docking station, single use sensor and analysis software. The docking station connects to a laptop or PC via a USB port enabling rapid data transfer when the handset is docked. Versatile, easy to use software allows the clinician to add comments to the results with the option to print for inclusion into the patient file, as required. • Improved accuracy ZedScan™: A quantitative assessment of the cervix Ordering Information Does ZedScan™ indicate HG-CIN? Return to follow up or routine surveillance according to local clinical practice Handset Technical Specification Dimensions (D x W X H) 49mm x 323mm x 157mm Operating Voltage 4.75V to 5.25V dc at 500mA (max) from the docking station only. Operating temperature range 5°C–35°C Storage temperature range -10°C–55°C Operating and storage humidity 0–90% The device does not contain parts which are likely to be sensitive to humidity. Operating and storage pressure 900–1100 mbar The device does not contain parts which are likely to be sensitive to atmospheric pressure. Level of ingress protection IPX0 Operating range 76Hz – 20kHz 0–1500Ω 20kHz – 100kHz 0–500Ω 100kHz – 625kHz 0–250Ω Docking Station Technical Specification Dimensions (D x W x H) 125mm x 276mm x 76mm 125mm x 276mm x 117mm (with docked handset) Operating Voltage 4.75V to 5.25V dc at 500mA (max) from a USB type A host or USB charger only. Operating temperature range 5°C – 35°C Storage temperature range -10°C – 55°C Operating and storage humidity 0    0% –9 The device does not contain parts which are likely to be sensitive to humidity. Operating and storage pressure 900  1100 mbar – The device does not contain parts which are likely to be sensitive to atmospheric pressure. Level of ingress protection IPX0 process flow chart • Better patient management • Simple, easy to use system • rgonomic wireless handset E • asy-to-use software for analysis E • equires minimal space R

increasing accuracy, informing decisions confidence to treat: reassurance to release when less means more when less means more Positive economic impact P • ortable hand-held device and docking station can C • ost savings associated with a 40% be easily transported between colposcopy suites Rapid, reliable, real-time results S – • urveys the cervix by taking 10   12 readings from Supplements colposcopy R • eferral cytology and colposcopic impression are qualify are identified for treatment, reducing the incidence of over-treatment using Single Point Mode Non-visual diagnostic C • onvenient single...