GBOSEN-CLSTelemetry Device

ST-R RAD-205000 Date: This docume transmitted in 1 St a FC Th i sub inte inte res by us e Dé Ce du 1) l acc un res mo con 0 Rev. : Written by Name: S ent is confidenti n any form or by atement CC and IC S is device c bject to th erference, erference sponsible f unauthoriz er’s author clarations dispositif règlemen t le dispositi cepter tout fonctionn sponsable odifications ntraindre l’ :A F C Signature: ial. Neither the w y any means (el consent fro Statement complies w he followin and (2) th that may for ANY int zed modific rity to opera s FCC et IC a été testé t de la FCC if concerné te interfére nement ind pour toute s non auto utilisateur CC RF Expo SENSIM Date: whole nor any p lectronic, mecha om the managem ts with ICC R g two con his device cause un d terference cations to ate the equ CC é et déclar C. Son fon é ne doit p ence reçue désirable. interféren orisées su à ne plus u osure inform ED Triggerf Approved b Name: part of this docu anical, or otherw ment of Sensim Rules and nditions: ( must acc desired op , for exam this equip uipment. ré conform nctionneme as causer e, y compr Remarqu nce (interfé ur le dispo utiliser son mation for fish® by Signature: ument may be re wise), or disclos med AG. All right part 15 of 1) This de cept any in peration. N mple RADIO pment. Suc me aux règ ent est sou d’interfére is les inter ue : le fa érences rad ositif. De t n équipeme Imple m Date: d Date: eproduced, store sed to any third ts reserved. f the FCC evice may nterference Note: The O OR TV i ch modifica glement IC umis aux c ences dang rférences r abricant n’ dio ou TV) telles mod ent mentation dd.mm.yyyy Authorize Name: SC red in any retriev party without th Rules. Op y not caus e received manufact u interferenc ations coul CC et à la s conditions gereuses, e risquant d’ ’est en a ), provoqué difications Page: ed by Signature: val system or he prior written peration is se harmful , including urer is not ce, caused ld void the section 15 suivantes: et 2) il doit engendrer aucun cas ée par des pourraient 1 / 2 s l g t d e 5 : t r s s t

SENSIMED Triggerfi sh ® User Manual Continuous IOP Monitoring SENSIMED Triggerfish ® User Manual November 2011 Because of continuous improvement of the product, prices and specifications are subject to change without notice. Changes to this manual are accomplished through reissue, either in response to user input or to continuous improvement of the product. Should errors, omissions or incorrect data be noted when using this manual normally, please contact SENSIMED Technical Support or your local SENSIMED representative. Issued by SENSIMED AG Route de Chavannes 37 Tel: +41 21 621 9191 1007 Lausanne Fax: +41 21 621 9193 Switzerland E-Mail: [email protected] Patents This product is manufactured and sold under one or more of the following global patents: US7137952, EP1401327, PCT/EP2007/061244. Trademarks SENSIMED, SENSIMED Triggerfish ® , and the stylized logos are trademarks of SENSIMED AG. Copyright © 2009-2011 SENSIMED AG. All rights reserved. Printed in Switzerland. Issued November 2011 Version: ST0001-16.EU.E-E 0344 SENSIMED AG Route de Chavannes 37 CH-1007 Lausanne Switzerland Not approved for sale in the U.S.A. Table of contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 SENSIMED Triggerfish ® . . . . . . . . . . . . . . . . . . . . . . . .6 Code No., Specification, Item, Quantity . . . . . . . . . . . . . . . . .8 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . 11 Wa r n i ngs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 SENSIMED Triggerfish ® Sensor. . . . . . . . . . . . . . . . . . .16 SENSIMED Triggerfish ® Antenna. . . . . . . . . . . . . . . . . .17 SENSIMED Triggerfish ® Recorder . . . . . . . . . . . . . . . . . 18 SENSIMED Triggerfish ® Data Cable . . . . . . . . . . . . . . . . 21 SENSIMED Triggerfish ® Software . . . . . . . . . . . . . . . . . 21 Sleeve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Directions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Preparations before using the SENSIMED Triggerfish ® . . . 27 Required Accessories for Sensor Fitting . . . . . . . . . . . . . . 27 Minimum Computer Configuration for SENSIMED Triggerfish ® Software . . . . . . . . . . . . . . . 27 Software Installation . . . . . . . . . . . . . . . . . . . . . . . . . . 28 How to Perform a Monitoring Session . . . . . . . . . . . . . . . 33 Activate the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . 33 Recorder Battery Check. . . . . . . . . . . . . . . . . . . . . . . . .33 Charge the Battery of the Recorder . . . . . . . . . . . . . . . . . . . 34 Switch off the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . 35 Prepare your Computer and Configure Patient Data. . . . . . .36 Configure Patient Data and enter Sensor ID . . . . . . . . . . . . . . 38 Place the Sensor in the Patient’s Eye . . . . . . . . . . . . . . . . 41 Fitting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Apply the Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . .44 Connect the Data Cable . . . . . . . . . . . . . . . . . . . . . . . . 48 Tighten the Sleeve on the Patient . . . . . . . . . . . . . . . . . . 50 Start of Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 End of Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Remove the Antenna . . . . . . . . . . . . . . . . . . . . . . . . . .54 Disconnect the Data Cable from the Antenna. . . . . . . . . . .55 Disconnect the Data Cable from the Recorder . . . . . . . . . . 55 Remove the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Retrieve Patient Monitoring Data . . . . . . . . . . . . . . . . . . 57 View Monitoring Data. . . . . . . . . . . . . . . . . . . . . . . . . .61 Legend. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62 Features and Use of the Software 2.0 . . . . . . . . . . . . . . . .64 Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Disposal of the Recorder . . . . . . . . . . . . . . . . . . . . . . . 66 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 67 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68 Errors displayed in the Software. . . . . . . . . . . . . . . . . . .68 Patient Preparation Errors. . . . . . . . . . . . . . . . . . . . . . .70 Compliance to Regulatory Standards. . . . . . . . . . . . . . . .71 Characteristics of the SENSIMED Triggerfish ® . . . . . . . . . 71 Electromagnetic Emissions and Immunity Information. . . . .72 Storage, Transport and Use conditions. . . . . . . . . . . . . . .78 Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Introduction6 Introduction This manual is written for clinical professionals familiar with moni- toring glaucoma patients and contact lens handling. You must read and understand this manual and all other information accompanying the SENSIMED Triggerfish ® . important This user manual is effective as of November 2011 and supersedes all prior manuals for the products described below. warning Please read this manual carefully before attempting to use the SENSIMED Triggerfish ® and keep this information for future use. SENSIMED Triggerfish ® The SENSIMED Triggerfish ® is a breakthrough solution to monitor fluctuations in intraocular pressure continuously up to 24 hours in order to aid the diagnosis and treatment of glaucoma. SENSIMED Triggerfish ® is: non-invasive and convenient, m…

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SAMPLE CONFIDENTIALITY FORM Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Gentlemen: This letter is to comply with Sections 0.457 and 0.459 pertaining to confidential material. Sensimed AG would like the following documents regarding this submission for FCC ID: GBOSEN-CLS to be kept confidential. Document: - Operational Description - Schematics - Block Diagram The above material contains trade secrets or technical data, which would customarily be guarded from competitors. We do not want these documents to be accessible to the general public. Sincerely, Sensimed AG Sacha Cerboni QA/RA Director

ST-RDC-ExternalPictures Recorder and Data Cable External Pictures Implementation Date: 22.05.2012 Page: 1 / 3 Written by Approved by Authorized by Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: SC This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 1 PURPOSE Number of photographs to clearly show the exterior appearance, the construction, the component placement on the chassis, and the chassis assembly. 2 EXTERNAL PICTURES ANTENNA ST-RDC-ExternalPictures Recorder and Data Cable External Pictures Implementation Date: 22.05.2012 Page: 1 / 3 Written by Approved by Authorized by Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: SC This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 3 EXTERNAL PICTURES RECORDER ST-RDC-ExternalPictures Recorder and Data Cable External Pictures Implementation Date: 22.05.2012 Page: 2 / 3 This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 4 EXTERNAL PICTURES DATA CABLE .

ST-RDC-IDLabel Recorder and Data Cable ID Label / Location Info Implementation Date: 22.05.2012 Page: 1 / 4 Written by Approved by Authorized by Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: SC This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 1 PURPOSE Picture or sketch showing label placement in sufficient detail so that the name and model number can be clearly read. A sample FCC ID Label showing the actual dimensions and material of the ID label. 2 RECORDER ID LABEL – LOCATION INFO & DIMENSIONS Label location (Rear face) ST-RDC-IDLabel Recorder and Data Cable ID Label / Location Info Implementation Date: 22.05.2012 Page: 2 / 4 This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 2.1 Recorder Label content with FCC ID number and logo location 2.2 Label actual dimensions and material Label material: Aluminium Dimension: Label high 21.75 mm Label lengh 34.75 mm ST-RDC-IDLabel Recorder and Data Cable ID Label / Location Info Implementation Date: 22.05.2012 Page: 3 / 4 This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 3 DATA CABLE ID LABEL – LOCATION INFO & DIMENSIONS 3.1 Label content with logo location Label location (Rear face) ST-RDC-IDLabel Recorder and Data Cable ID Label / Location Info Implementation Date: 22.05.2012 Page: 4 / 4 This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 3.2 Label actual dimensions and material Label material: Aluminium Dimension: Label high 14.00 mm Label lengh 29.00 mm

ST-RDC-InternalPictures Recorder and Data Cable Internal Pictures Implementation Date: 22.05.2012 Page: 1 / 3 Written by Approved by Authorized by Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: SC This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 1 PURPOSE To provide sufficient views of the internal construction to define component placement and chassis assembly. 2 INTERNAL PICTURES ANTENNA ST-RDC-InternalPictures Recorder and Data Cable Internal Pictures Implementation Date: 22.05.2012 Page: 2 / 3 Written by Approved by Authorized by Date: Name: Signature: Date: Name: Signature: Date: Name: Signature: SC This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 3 INTERNAL PICTURES RECORDER ST-RDC-InternalPictures Recorder and Data Cable Internal Pictures Implementation Date: 22.05.2012 Page: 3 / 3 This document is confidential. Neither the whole nor any part of this document may be reproduced, stored in any retrieval system or transmitted in any form or by any means (electronic, mechanical, or otherwise), or disclosed to any third party without the prior written consent from the management of Sensimed AG. All rights reserved. 4 INTERNAL PICTURES DATA CABLE

montena emc sa route de Montena 75 1728 Rossens Switzerland phone +41 26 411 93 33 fax +41 26 411 93 30 www.montena.com [email protected] montena emc ag Technopark Blumenegg Blumeneggstrasse 50 9403 Goldach Switzerland phone +41 71 278 41 92 fax +41 71 278 41 93 montena emc ag Ringstrasse 10 5432 Neuenhof Switzerland phone +41 56 290 30 35 montena emc ag Postfach 1315 3072 Ostermundigen Switzerland phone +41 79 256 21 55 1 / 21 Test laboratory accredited according to ISO 17025 by the Swiss Accreditation Service SAS Laboratoire d'essai accrédité selon ISO 17025 par le Service d’accréditation suisse SAS Prüflabor akkreditiert nach ISO 17025 durch die Schweizerische Akkreditierungsstelle SAS Registration number Numéro d'accréditation Akkreditierungsnummer STS 024 Schweizerischer Prüfstellendienst Service suisse d'essai Swiss testing service Report: Rapport: Bericht: Electromagnetic compatibility and Radio spectrum Matters Report no: Rapport no: Bericht Nr: 16'638 Product name: Nom du produit: Produktname Telemetry Set Mandate no: Mandat no: Auftrag Nr: 20119907 Serial no: No de série: Seriennummer: 2-R32-0011 Model number: Numéro de modèle: Modellnummer: ST5000 Customer: Client: Kunde: Sensimed AG Rte de Chavannes 37 1007 Lausanne Switzerland Date of test: Date de l'essai: Prüfdatum: September 26, 2011 Standards / Normes / Normen Result Résultat Ergebnis 47 CFR, Part 15 (Subpart C, Intentional radiator: §§ 15.207; 15.209, 15.227) Pass Industry Canada RSS-Gen, General Requirements and Information for the Certification of Radio Apparatus Pass RSS-310, Licence-exempt Radio Apparatus: Category II Equipment Pass Test performed by Essai effectué par : Prüfer Report prepared by Rapport préparé par : Berichterstatter Report controlled and approved by Rapport contrôlé et approuvé par : Bericht kontrolliert und genehmigt durch Mr E. de Raemy Mr E. de Raemy Mr A. Bieri Rossens, January 17, 2012 (Issue Date / Date d'édition / Ausstelldatum) V2011Avril19 Main language / Langue principale / Hauptsprache : english / français / deutsch The present document results from tests on a specimen and does not prejudge to the conformity of all the manufactured products. - Le présent document résulte d'essais sur un spécimen. Il ne préjuge pas de la conformité de l'ensemble des produits fabriqués à l'objet essayé. - Dieser Bericht beinhaltet die Prüfergebnisse des geprüften Gerätes und macht keine Aussage über die Konformität weiterer gleicher Geräte. q:\mandats\2011\20119907_sensimed_telemetry\rap_sensimed_16638_fcc.doc Page / Seite 2 / 21 No. / Nr. : 16'638 (20119907) montena emc sa CH-1728 Rossens - Switzerland / phone +41 26 411 93 33 / fax +41 26 411 93 30 / www.montena-emc.com / [email protected] Contents / Table des matières / Inhaltsverzeichnis Page/Page/Seite FOREWORD / AVANT-PROPOS / VORWORT.............................................................................................. 2 1. SUMMARY OF TEST RESULTS / RÉSUMÉ DES RÉSULTATS D'ESSAIS / ZUSAMMENFASSUNG DER PRÜFERGEBNISSE......................................................................................................................... 3 2. APPLIED STANDARDS / NORMES APPLIQUÉES / VERWENDETE NORMEN............................................ 3 3. CLIENT / CLIENT / KUNDE............................................................................................................... 4 4. EQUIPMENT UNDER TEST / EQUIPEMENT À L'ESSAI / PRÜFLING......................................................... 4 4.1 Identification / Identification / Identifikation ....................................................................... 4 4.2 Pictures of the EUT / Photos de l’EST / Fotos des Prüflings............................................ 5 4.3 Classification / Classification / Klassierung ...................................................................... 6 4.4 Ports / Accès / Anschlüsse ............................................................................................... 6 4.5 Modifications / Modifications / Angebrachte Änderungen ................................................6 5. TEST CONDITIONS / CONDITIONS D'ESSAI / TESTBEDINGUNGEN........................................................ 7 5.1 Climatic conditions, location and date / conditions climatiques, lieu et date / klimatische Bedingungen, Ort und Datum ........................................................................ 7 5.2 Test facility and methodology / Lieu d’essai et méthodologie / Prüfort und Methodik...... 7 5.3 Attendant persons / Personnes présentes / Anwesende Personen ................................. 7 5.4 Test configuration / Configuration d’essai / Prüfkonfiguration .......................................... 8 5.5 Operating conditions / Conditions de fonctionnement / Betriebszustand ......................... 8 5.6 Auxiliary equipment / Matériel auxiliaire / Zusatzgeräte ................................................... 9 6. EMISSION.................................................................................................................................... 10 6.1 Radiated emission - Magnetic field................................................................................. 11 6.2 Carrier - Radiated magnetic field .................................................................................... 14 6.3 Radiated emission - Electromagnetic field (30 MHz to 1 GHz) ...................................... 17 7. EMISSION, MODULATION, AND TRANSMISSION CHARACTERISTICS.................................................... 20 7.1 Designiation of emission ................................................................................................. 21 Foreword / Avant-propos / Vorwort The Telemetry Set has two functioning modes: 1) measuring and 2) battery charging. It is not possible to use both modes at the same time. As measuring is the main function of the system, it has been tested in this mode. Furthermore, in this mode only the short data cabl…

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ST- -RDC-TestS Date: This docume transmitted in 1 PU Dra em dra con wit 2 TE Setup Photo Written by Name: S ent is confidenti n any form or by URPOSE awings or mission and awings or ntained in hout glare ST CONFI s Re Signature: ial. Neither the w y any means (el consent fro photograp d showing photogra p the test or dark sp IGURATIO ecorder and Setu Date: whole nor any p lectronic, mecha om the managem phs showin the test s phs must s report. A pots and m ON d Data Cab up photos Approved b Name: part of this docu anical, or otherw ment of Sensim ng the tes set-up for show eno Any photog must clearly ble Test by Signature: ument may be re wise), or disclos med AG. All right st set-up f the highe ugh detail graphs use y show the Implem e Date: 08 Date: eproduced, store sed to any third ts reserved. or the hig est radiate l to confirm ed must b test config entation 8.05.2012 Authorize Name: SC red in any retriev party without th hest line ed emissio m other i n be focused guration us Page: 1 ed by Signature: val system or he prior written conducted n. These nformation d originals sed 1 / 4 d e n s ST- -RDC-TestS This docume transmitted in 3 AU Setup Photo ent is confidenti n any form or by UXILIARY E s Re ial. Neither the w y any means (el consent fro EQUIPME ecorder and Setu whole nor any p lectronic, mecha om the managem NT d Data Cab up photos part of this docu anical, or otherw ment of Sensim ble Test ument may be re wise), or disclos med AG. All right Implem e Date: 08 eproduced, store sed to any third ts reserved. entation 8.05.2012 red in any retriev party without th Page: 2 val system or he prior written 2 / 4 ST- -RDC-TestS This docume transmitted in 4 RA 4.1 An 5 CA 5.1 An Setup Photo ent is confidenti n any form or by ADIATED E echoic ch ARRIER – R echoic Ch s Re ial. Neither the w y any means (el consent fro EMISSION hamber (fe RADIATED hamber (fe ecorder and Setu whole nor any p lectronic, mecha om the managem N – MAGNE errites) D MAGNE errites) d Data Cab up photos part of this docu anical, or otherw ment of Sensim ETIC FIEL ETIC FIELD ble Test ument may be re wise), or disclos med AG. All right LD D Implem e Date: 08 eproduced, store sed to any third ts reserved. entation 8.05.2012 red in any retriev party without th Page: 3 val system or he prior written 3 / 4 ST- -RDC-TestS This docume transmitted in 6 RA 6.1 An Setup Photo ent is confidenti n any form or by ADIATED E echoic ch s Re ial. Neither the w y any means (el consent fro EMISSION hamber (fe ecorder and Setu whole nor any p lectronic, mecha om the managem N – ELECT errites) d Data Cab up photos part of this docu anical, or otherw ment of Sensim TROMAGN ble Test ument may be re wise), or disclos med AG. All right NETIC FIEL Implem e Date: 08 eproduced, store sed to any third ts reserved. LD (30 MH entation 8.05.2012 red in any retriev party without th Hz TO 1GH Page: 4 val system or he prior written Hz) 4 / 4