Sales and Service: Ziemer Ophthalmic Systems AG, CH
Contents
1. DCT may offer some clinically relevant advantages over conventional Goldmann 03 01 2005 AW PAS_ProdDescr_v8B doc O 2005 Ziemer Ophthalmic Systems AG www pascaltonometer com How the PASCAL Tonometer works PASCAL is always ready for operation just swivel it into place before the patients eye activate it with a single touch of the Blue Knob advance it to touch the patient s eye pull back after a few seconds and immediately see the numerical result mem precise and unambiguous on the unit s matched contact surface illuminated LCD display When the PASCAL SENSORTIP touches the corneal surface a solid state piezoresistive pressure sensor built into the center of the contoured concave tip surface directly measures IOP The contour surface has been calculated to generate minimum dis tortion of the cornea contour matching meze and hence minimize tension forces within through slit lamp microscope the cornea The device can be mounted on any slitlamp and is advanced towards the patient s eye by using the slitlamp s joystick The SENSORTIP is mounted on a spring loaded Cantilever which provides a constant appositional force The pressure detected by the sensor is digitized and stored in the device s memory A built in microprocessor determines the intra ocular pressure IOP and its pulsatile fluctuations ocular pulse amplitude OPA caused by cardiac activity IOP and OPA are displayed as numeric values on an LCD2. PASCA DYNAMIC CONTOUR TONOMETER www pascal tonometer com tei ima Na gt B EF A pre ads ia zrinka PRP pi ren a i gt we u a The Precision Tonometer ZIEMER OPHTHALMIC SYSTEMS OF SWITZERLAND Q 4 SOCAL JAN DYAM T CONTOUR TONCMETEE The New Device for Ocular Precision Tonometry o The PASCAL Dynamic Contour Tonometer is a third generation digital contact tonometer for ophthalmological applications The slitlamp mounted device furnishes a numeric output of intra ocular pressure IOP and of ocular pulse amplitude OPA upon touching the cornea for a few seconds It measures pulsatile IOP directly and continuously dynamically Features Clinical Benefits m Slitlamp mounted same easy operation as the familiar applanation tonometer Disposable tip cover prevents contamination and potential infection safe and convenient o NANNA MG E LE Direct measurement of pressure Fs pe kh a i no systematic errors from force to pressure conversion Numerical display of result avoids operator bias and reading errors Self calibrating no calibration required Battery operated no cabling Transparent tip provides for visual control of corneal interface All functions are accessed with the unique Blue Knob easy single button operation PASA mat component SENSORTIP O Cantilever spring loaded arm Unlike applanation tonometers whi
3. Systems AG CH 2562 Port Switzerland phone 41 32 332 7050 vision ziemer ophthalmics com Manufactured by Swiss Microtechnology AG a Ziemer Ophthalmics Group Company phone 41 32 332 7080 vision smitag ch Technical Data Class Ila medical device CE marked FDA 510 k cleared Device mounts on tonometer bracket or accessory footplate of slitlamp Dimensions Housing 170 mm H x 88 mm W x 40 mm D Weight ca 210 grams Display of results backlit LCD 58 x 24 mm 2 2 by 1 Detection range IOP 5 200 mmHg OPA gt 1 0 mmHg numerical precision 0 2 mmHg Analog digital conversion 100 Hz sampling rate 12 bit resolution Recording time ca 3 secs up to 180 secs Calibration self calibrating automatic compensation of atmospheric pressure Optional Test Kit is available for checking tonometer calibration and performance Appositional force 1 gram SensorTip diameter 7 mm pressure sensor 1 2 mm Contact surface concave shaped to match corneal contour Cleaning sterilization SensorTip is protected from direct eye contact by sterile single use SensorCap covers Power battery operated 3V battery pack Product Information E 0297 Caution Federal U S law restricts this device to sale by or on the order of a physician Manufacturer SMT Swiss Microtechnology AG CH 2562 Port Switzerland a Ziemer Ophthalmic Systems Group Company ui Sales amp Service Ziemer Ophthalmic Systems AG CH 2562 Port Switzerland and i
4. ase contact your local distributor or consult the PASCAL Tonometer website for address information Regular performance checks are recommended and may be performed by the user by means of the optional Test Kit or by service centers and distributors If the test reveals a need for re calibration the device must be sent to a Service Center for maintenance Convenient Maintenance and Service Contracts are available Warranty The PASCAL Dynamic Contour Tonometer comes with a 12 month limited warranty on parts and workmanship Please consult Ziemer Ophthalmic Systems Warranty Terms for details Ordering Information Accessories 311 761 001 Rechargeable Battery Kit Battery charger and 2 rechargeable batteries 311 001 00x PASCAL Dynamic Contour Tonometer System 311 761 005 Rechargeable Batteries package of 2 Part Nbr System System includes Main Unit one SENSORTIP carrying case and the following starter set of consumables SENSORCAPS 24 ea in APPLIPACK packaging Battery Packs disposable 2 ea 311 620 001 Test Kit for checking calibration and system performance 311 510 002 SENSORTIP 311 510 003 SENSORTIPS package of 3 311 640 005 Adapter kit for mounting the PASCAL Main Unit on Haag Streit type slitlamps using central base post 311 640 006 Base plate with fixation pins and locking key for mounting PASCAL on bottom 311 640 007 Footplate A standard 311 640 008 Footplate B special for non HS slit
5. ch are influenced by corneal thickness Mounting bracket and other characteristics of the cornea and hence may produce misleading Control switch Blue Knob estimates of IOP a contour tonometer provides an accurate direct measurement of true IOP which is independent of inter individual variations LCD Display in corneal properties Wireless printer optional IOP measurement works correctly even on post LASIK eyes mine a O PASCAL detects and accurately measures the dynamic pulsatile fluctuations War ia in IOP and thus permits a more detailed assessment parent of the pressure range to which the eye is subjecied due to pulsatile ocular blood flow No fluorescein staining is required for the measurement Convenient documentation with optional wireless printer Prints all the values shown on the LCD display and the actual IOP curve In summary we found IOP measurements taken with the new DCT Dynamic Contour Tonometer to have an excellent concordance with measurements obtained by the GAT Goldmann Applanation Tonometer In the subjects studied IOP or axial length type applanation tonometers for screening and management of patients with suspected or known glaucoma Comparison of Dynamic Contour Tonometry with Goldmann Applanation Tonometry Kaufmann C Bachmann LM Thiel MA IOVS 2004 Vol 45 No 9 3118 3121 measurements with the DCT did not depend on corneal thickness corneal curvature
6. display The part of the tip touching the eye is protected by a single use disposable cover the SENSORCAP The unit is battery operated This is what the PASCAL tonometer measures and this is the result presented on the LCD m ees es ee mn vo Viva Vava vAVAVA rai Nila i L 1 above result displayed immediately after measurement below result recalled from list of stored results _ gt time Original ocular pulse curve detected in real time by PASCAL IOP P mmHg average of pulse minima 3 6 minima are detected 100Hz sampling freguency in a curve range optimized for data guality Yellow cursors range of optimum curve guality as determined by OPA A mmHg difference between mean minimum and mean software maximum of pulse curve Blue line level of mean diastolic IOP The pressure level G Ouality of data and of result 1 is optimum 2 and 3 are corresponding to this line is displayed as IOP acceptable 4 and 5 are unacceptable and should be discarded Green line level of mean systolic IOP The difference between and measurement repeated green and blue line is displayed as OPA nnn displayed only in list of stored results measurement Note This curve representing raw data as collected by the PASCAL SAN Kumoa device is only visible if an optional printer or PC is connected H displayed only in list of stored results cardiac pulse rate beats min Sales and Service Ziemer Ophthalmic
7. lamps 311 011 00x PASCAL Dynamic Contour Tonometer System as described above but with wireless printer interface Consumables SENSORCAPS 240 sterile disposable tip covers in APPLIPACK packaging 311 751 002 1 751 002 Replacement Batteries not rechargeable package of 5 Printer 311 701 201 311 951 101 PASCAL User Manual on CDROM in English 311 660 001 German French Italian and Spanish Wireless portable thermal printer battery operated uses 58mm roll paper 311 660 010 Thermal roll paper 58mm width 311 951 201 PASCAL Quick Reference Sheet in English also available in German French Italian and Spanish Actual product characteristics specifications and prices are subject to change
8. ts network of established ophthalmic equipment distributors www pascal tonometer com Availability Europe CE marked USA FDA 510 k cleared For other countries availability may be restricted due to local registration requirements please contact Ziemer Ophthalmics for details a Configuration single unit completely assembled self installed by user screws onto available tonometer bracket or fits onto pivotal axis of most Haag Streit type slilamps Adapter Kits for other slitlamps Zeiss Rodenstock are available SENSORTIP may be detached for cleaning Basic configuration includes attachment kit for mounting the unit on swiveling bracket of slitlamp swiveling bracket not supplied two battery packs and initial supply of sterile single use SENSORCAPs With aluminum carrying case and operating manual Accessories Consumables e Slitlamp adapter kit required for different types of slitlamp attachment please check with your distributor e Additional detachable SensorTips e Wireless interface for connecting to an optional printer or to a Personal Computer Test Kit for checking tonometer calibration and performance e Sterile SENSORCAP disposable tip covers in APPLIPACK packaging package of 240 ea e Disposable Battery Packs standard or Rechargeable Battery Pack with battery charger optional u Service Regular Maintenance and Repair Service is available from the manufacturer and from local certified Service Centers ple
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