Digitrapper ph-z Monitoring System Facts & Features

Transcription

1 Digitrapper ph-z Monitoring System

2 Supported by the recognized Leader in GI Diagnostics Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam video capsules for the small bowel, esophagus and colon, industry-leading ManoScan high resolution manometry and Bravo wireless and Digitrapper ph and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. The Digitrapper ph-impedance Monitoring System The Digitrapper ph-z Monitoring System, featuring the new Digitrapper ph-z recorder, provides added insight for reflux monitoring by measuring both acid and non-acid reflux and supporting dual-channel ph testing. The Digitrapper system includes AccuView analysis software, which presents study data in a clear, anatomically-oriented fashion and rapidly generates reports using advanced analysis methods. The Digitrapper ph-z recorder is commonly recognized as a standard for ambulatory esophageal 24-hour ph monitoring and is used for catheter-based ph or ph-impedance monitoring. Given Imaging offers the only complete reflux monitoring solution! The latest version of the proven AccuView analysis software is now compatible with all current reflux recorders provided by Given Imaging and allows data upload from: Recorders Digitrapper ph-z Digitrapper ph 400 (Version 0203 & 0204) Bravo AccuTrac ph-z The software is also backward compatible supporting the import of existing studies created with the following software versions: Software AccuView TM (Version 4.1.1) Polygram.Net TM (Version 4.21) GastroTrac ph testing application (Version 4.4a and 5.0) RAPID ph (Version 1.0/1.1) If you are interested Given Imaging can provide you with the capsule-based Bravo ph monitoring system - the ideal solution for prolonged ph studies (up to 96h) or for patients who do not tolerate catheters to truly complete your reflux monitoring tools.

3 Recorder Digitrapper ph-z Recorder The Digitrapper ph-z recorder with combined ph-impedance provides total reflux monitoring. Dual capability: Volume: Weight: Power: Recording time: Display: Handling: Multiple languages: Technical Details ph: Number of ph channels: Recording rate range: Measurement range: Measurement accuracy: Catheter type: Impedance: Number of impedance channels: Measurement range: Measurement accuracy: Measuring frequency: Measuring current: Sampling rate: ph-impedance or ph-only Small, 200 ccm Lightweight with 150 g ABS plastic housing 2 x AA batteries Up to 48 hours Easy to read LCD Multiple event buttons/patient event buttons Yes 2 1 sample/sec to 1 sample/10 sec 1 to 10 ph 0.1 ph Antimony 6 100Ω to 10kΩ Better than ±5% above 200 Ω Between 1KHz and 2KHz Typically 15μA rms 64Hz

4 Catheters VersaFlex ph & ph-z Catheters VersaFlex reflux catheters set the worldwide standard for reliability and patient comfort in ph and ph-impedance monitoring. The small diameter of the Versaflex catheters makes them acceptable for use in pediatric as well as adult applications. ph-impedance: VersaFlex-Z Single Use Catheter Use: Material: Sensors: Sensor technology: Impedance: Impedance channels: Reference: Diameter: Connector: Calibration: Packaging: CE Mark: Storage: Shelf life: Versions: Single use Bio-compatible Polyurethane, latex free, X-ray visible Up to 2 ph sensors Antimony Sensor Technology Tin-plated copper 6 Internal Ag/AgCl 6.0 Fr 1 ph-impedance: Standard 10-pin RJ45 2 ph-impedance: Standard 10-pin RJ45 + standard 8-pin RJ45 Buffer set ph4.0 - ph7.0 5 or 10-pack Yes Catheter temperature and storage requirements are between 0 C and 30 C 12 months Multiple configurations including pediatric & infant version available ph-only: VersaFlex Single Use Catheter Use: Material: Sensors: Sensor technology: Reference: Diameter: Connector: Calibration: Packaging: CE Mark: Storage: Shelf life: Versions: Single use Bio-compatible Polyurethane, tan color & latex free, X-ray visible Single or dual ph sensors Antimony Sensor Technology Internal reference Ag/AgCl 4.7 Fr & 6.4 Fr Standard 8-pin modular RJ45 Buffer set ph7.0 - ph1.0 or Buffer set ph4.0 - ph pack Yes Catheter temperature and storage requirements are between 0 C and 30 C 18 months Multiple configurations available

5 ph-only: GeroFlex Multiple Use Catheter* Use: Material: Sensors: Sensor technology: Reference: Diameter: Connector: Calibration: Packaging: CE Mark: Storage: Shelf life: Multiple use up to five times Bio-compatible Polyurethane, latex free, X-ray visible Single or dual sensors Antimony Sensor Technology External Ag/AgCl 6.0 Fr Standard 8-pin modular RJ45 Buffer set ph7.0 - ph1.0 Single catheter Yes Catheter temperature and storage requirements are between 0 C and 30 C 18 months * only to be used in combination with Digitrapper ph 400 Software AccuView TM 5 Analysis Software The new AccuView software supports the upload and analysis of ph & ph-impedance data collected from multiple ambulatory reflux monitoring recorders in Given Imaging s portfolio. In addition it allows the migration of study data from previous software versions like Polygram.Net, RAPID ph, GastroTrac ph & AccuView. Upload: Temporal display: Anatomically aligned display: Patient data review: Analysis tools: Graphical tools: User-friendliness: Report creation: Allows upload from following recorders: Digitrapper ph-z, Digitrapper ph 400 (version 0203 & 0204), Bravo, AccuTrac ph-z High resolution color map plot with instant switching to conventional line traces Impedance profile and color bar modes superimposed on anatomy of esophagus Replay (video) and static (scroll through) file review modes; Analysis tools available in each mode Built-in functions provide quantitative measures of ph, impedance, reflux, symptom association and event periods Facilitate localization of sphincters and PIP; Detailed analysis can be calculated in either automated or manual modes Drag & drop functionality for easy & time-saving patient diary editing Customizable options allow for streamlined and professional patient reports (all common reflux scores) Benefits Combined ph-impedance system: Automated episode identification: Impedance color contour display: Playback feature: Unique software integration: Enables you to reliably distinguish between acid and non-acid episodes Improves event detection and reduces the guesswork in interpreting a study Provides a new clarity visualizing bolus movement and direction of flow For dynamic reflux study review in a video scrolling format Transfers patient data from ManoView HRM analysis for exact catheter position in anatomy

6 Computer Requirements Minimum System Requirements The Digitrapper ph-z Monitoring System can be used in conjunction with the ManoScan Modular Cart System which includes a computer that meets the below requirements and on any stand-alone computer/workstation that meets the below requirements. Minimum Hardware Requirements: For ph-impedance Studies Pentium CORE 2 DUO 1.6 GHz 1 GB RAM 1 GB available hard disk CD-ROM Minimum 24 bit color 1024 x 768 video adaptor USB 2.0 support For ph-only Studies Pentium IV 2.8 GHz 1 GB RAM 1 GB available hard disk CD-ROM Minimum 24 bit color 1024 x 768 video adaptor USB 2.0 support Recommended Hardware Requirements for Optimum Performance: For ph-impedance Studies Pentium CORE 2 DUO at 3.0 GHz or greater 2 GB RAM 1 GB available hard disk CD-ROM Minimum 24 bit color 1024 x 768 video adaptor USB 2.0 support For ph-only Studies Pentium CORE 2 DUO 2 GB RAM 1 GB available hard disk CD-ROM Minimum 24 bit color 1024 x 768 video adaptor USB 2.0 support Operating System Requirements: AccuView 5 is compatible with all of the following operating systems: Windows XP SP3 32 bit only Windows 7 32 and 64 bit Software Prerequisites: Minimum Microsoft Word 2003, recommended Word 2007 or Word 2010 with Microsoft save as PDF add-in Adobe Acrobat Reader

7 Notes/Questions:

8 Authorized distributor of Given Imaging Copyright Given Imaging Ltd. GIVEN, GIVEN & Design, PILLCAM, PILLCAM & Logo, PILLCAM EXPRESS, AGILE, RAPID, RAPID ACCESS, ICCE, ICCE Logos, International Conference on Capsule Endoscopy, BRAVO, BRAVO PH SYSTEM, VUESPAN, VERSAFLEX, GEROFLEX, REPHLUX TRACER, GASTROTRAC, BILITEC, DIGITRAPPER, PHERSAFLEX, MANOSCAN, MANOSHIELD, MANOVIEW, ACCUTRAC, ACCUVIEW, and POLYGRAF ID are Trademarks and/or Registered Trademarks of Given Imaging Ltd., its subsidiaries and/or affiliates in the United States and/or other countries. All other company or product names are the trademarks or registered trademarks of their respective holders. All rights not expressly granted are reserved