Vitalograph Products and Services Guide

Transcription

1 Vitalograph Products and Services Guide

2 Vitalograph is a world leading provider of outstanding quality respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning half a century we continue to make valuable contributions to effective medical care and enhanced quality of life. Vitalograph have been pioneers since our earliest days when we first made it possible to take spirometry out of laboratories and bring it into GPs surgeries. Our continuous investment in product development reflects our pioneering spirit and demonstrates our commitment to supporting respiratory professionals and those they care for. CONTENTS MONITORING ASTHMATICS A asma-1 1 A asma-1 usb 2 SCREENING FOR COPD A copd-6 3 A copd-6 usb 4 SMOKING CESSATION A lung age 6 MONITORING CYSTIC FIBROSIS AND TRANSPLANT PATIENTS A lung monitor 7 A lung monitor usb 8 FOR HIGH QUALITY SPIROMETRY TESTING A Spirotrac V 10 A Pneumotrac 11 A In2itive 14 A Alpha 15 A Compact 18 A Micro 19 A Precision Syringe 21 RESPIRATORY DISPOSABLES 22 Managing Director, Vitalograph Ltd. SPIROTRAC OVER-READ SERVICE 26 RESPIRATORY CLINICAL TRIALS SERVICES 27

3 Vitalograph asma-1 Electronic asthma monitor The Vitalograph asma-1 is an easy to use, yet sophisticated, electronic asthma monitor that makes the monitoring of asthma simpler and more accurate than ever before. By measuring FEV1, as well as peak flow, the asma-1 gives a clear picture of lung health. The asma-1 stores up to 600 test sessions and automatically assesses test quality. A Measures FEV1 and peak flow A Simple to use A Large, easy to read display A No need for record cards A Quality of blow indicator A Suitable for multi-subject use with standard size SafeTway mouthpieces A Uses long life AAA batteries A Variants with communications capability available Vitalograph asma-1 usb Electronic asthma monitor The asma-1 usb links to your PC to produce electronic and hard copy PDF reports for archiving or printing. The reports include: A Subject ID and name A Age, height, gender and optional weight field A Best PEF and FEV1 fields automatically populated A BMI calculated (from height and weight) A Personal best FEV1, PEF and zones as set in asma-1 A Indications of blow quality, number of blows and diurnal variation A Device ID automatically transmitted with the data A Ability to add comments to the report A Trend graphs of FEV1 and PEF A Optionally separate graphs of am and pm sessions A Information presented in tabular and graphical form A Time/date stamp for each session Order Number: Order Number: Monitoring asthmatics Monitoring asthmatics 1 2

4 Vitalograph copd-6 COPD screening monitor The Vitalograph copd-6 is an accurate and cost effective case selection or screening device that identifies potential cases of COPD. A Identifies those at risk of COPD at the pre-symptomatic stage A Screens out those who do not have COPD A Displays the key parameters for clinical interpretation including FEV1, FEV6, ratio and % predicted A Displays the obstructive index and COPD GOLD classification (normal and stage I IV and lung age) A Detachable flowhead makes cleaning simple A Built-in quality of blow indicator A Designed for multi-subject use A Variants with communications capability available Order Number: Vitalograph copd-6 usb COPD screening monitor The copd-6 usb links to your PC to produce electronic and hard copy PDF reports for archiving or printing. The reports include: A Subject ID and name (weight field optional) A Add comments to the report A Age, height, gender, device ID, time/date fields automatically populated A Predicted values, 3 test results, best test, % predicted and lung age automatically tabulated A Obstructive index and COPD (GOLD) Classification A BMI calculated A Blow quality indicator A Interpretation of results A Automatically names the.pdf file using subject name and date A Ability to customise report headers Order Number: Screening for COPD Screening for COPD 3 4

5 Vitalograph lung age A motivational tool for smoking intervention by healthcare professionals The Vitalograph lung age is a motivational tool for smoking intervention by healthcare professionals. A Quick and simple to use A Interprets lung age to help illustrate the impact of smoking on the subject s lungs A Measures FEV1 and displays FEV1 as a % of predicted values A Colour zones indicate abnormality level A Automatically calculates the best FEV1 from multiple blows A Can be used with hygienic SafeTway mouthpieces A Easy to clean flowhead A Language independent A Can be custom branded Order Number: Smoking cessation 5 6

6 Vitalograph lung monitor For simple, accurate lung function monitoring at home This easy to use home monitoring device is designed to record key lung function parameters for those with respiratory conditions including cystic fibrosis and transplant patients. A Measures FEV1, FEV6 and the ratio A Displays % of personal best FEV1 A Suitable for multi-subject use in clinic with SafeTway mouthpieces A Simple to use with a large, easy to read display A Electronic record no need for record cards A Stores 200 test sessions A Automatically stores best values in a test session A Quality of blow indicator A Easy to clean flowhead A Uses long life AAA batteries A Meets ATS/ERS:2005 Spirometry Guidelines A Variants with communications capability available Order Number: Vitalograph lung monitor usb For simple, accurate lung function monitoring at home The lung monitor usb links to your PC to produce electronic and hard copy PDF reports for archiving or printing. The reports include: A Subject ID and name A Age, height, gender and weight fields optional A Best FEV1, FEV6, FEV1/FEV6 ratio and FEF automatically populated A Personal best FEV1 set in the lung monitor A Device ID and time/date fields automatically populated A BMI calculated A Blow quality and number of blows indicated A Ability to add comments to the report A Uses long life AAA batteries A Information presented in tabular and graphical form A Report headers can be customised Order Number: Monitoring cystic fibrosis and transplant patients 7 Monitoring cystic fibrosis and transplant patients 8

7 Vitalograph Spirotrac V Power & sophistication made simple Combines the power of your Windows PC and your network with Vitalograph s proven measuring technology for early detection of respiratory disease and improved management of COPD and asthma. A Intuitive user interface with workflow orientated presentation A Automatic FEV1 trend chart of actual and normal range data as subject is selected A Open session, f/v and v/t curves, all test data and test quality in one view A Automatic storage of all test data and events, including calibration log A Built-in test quality checks (daily accuracy check can be forced if required) A Choice of attractive incentives A Comprehensive, configurable reports for spirometry sessions and trending A Fully scalable database capacity using powerful Microsoft SQL server technology A Links to Vitalograph Over-Read Spirometry QA Service and practice management systems Order Number: For high quality spirometry testing 9 10

8 Vitalograph Pneumotrac Simple PC spirometry A Vitalograph Pneumotrac simply plugs into a PC s USB port A Unlock the power of your PC for a low-cost spirometry solution A Simply plug into any Windows PC and run the install wizard A Adaptable, interactive, user friendly software for full automation A Network ready, standardised communications with other databases A Proven spirometry software with automatic test quality control and trending A Accurate, robust and linear Fleisch pneumotachograph A Hygienic drying fan to inhibit micro-organism survival A Automatic log of accuracy checks and calibration updates A Spirotrac software is simple to use and has an installed base of thousands Order Number: Vitalograph Pneumotrac (including Spirotrac V Software) For high quality spirometry testing 11 12

9 Vitalograph In2itive For high quality spirometry on the move Vitalograph In2itive combines the benefits of full spirometry, data integration and mobility in a small lightweight handheld spirometer. A Features Fleisch flow measuring technology and simple icon driven menu A Storage for subjects A Subject data from Spirotrac V may be downloaded automatically saving time and eliminating data entry errors A Session can be automatically transferred to, and synchronised with, Spirotrac V A Colour touch screen A Battery life for a full day of off-site testing A Over 50 test parameters A Choice of child incentives with sound effects A Remote flowhead option enables the subject to view incentives while performing the test A Print via your PC (Spirotrac V or Vitalograph Reports) or print direct to USB printer (using optional print cradle) Order Number: In2itive & Spirotrac V Software or In2itive with USB Printer Cable For high quality spirometry testing 13 14

10 Vitalograph ALPHA Effective spirometry pure & simple The Vitalograph ALPHA is a dedicated all in one desktop spirometer featuring the proven Vitalograph Fleisch Pneumotachograph to provide unparalleled accuracy and outstanding performance. A Dedicated all-in-one desktop unit A Simple to use A Rapid and cost effective testing A Clear and bright colour screen A Accurate Fleisch pneumotachograph A Measures VC, FVC, FEV1, FEV1 %, PEF, FEF25-75 A On-screen visualisation of volume/ time and flow/volume curves A Tests can be stored for serial and pre/post testing A Presents the test information in clear, easy to read format Order Number: For high quality spirometry testing 15 16

11 Vitalograph COMPACT A powerful and sophisticated spirometer for the expert user A It stores thousands of subjects and trends their lifetime test data A Full flexibility and communication options as standard A Packed with features including colour touch-screen operation, accurate Fleisch pneumotachograph, integral printer which prints 200 tests per roll and on-screen visualisation of volume/time and flow/volume curves A Selection of patient incentives and trend graphs A Wide range of selectable parameters A Best test selection available A Automatically stores every test and recalls prior test data along with the current test A Internal storage facility for thousands of subjects and their lifetime of test data A Archives all test data while data management will trend over 70 years of test results and plot against the normal predicted changes A Real time clock A Links to PC A Autoclaveable flowhead Order Number: For high quality spirometry testing 17 18

12 Vitalograph micro Pocket spirometer with PC spirometry reports A Single breath evaluation of FVC, FEV1, FEV1%, PEF A Complete with Vitalograph Reports PC software creating PDF reports A Report includes f/v and v/t curves with test quality, predicted values and interpretation A Parameters FVC, FEV1, FEV1%, PEF, FEV6, PEF, FEF25, FEF50, FEF75, FEF25-75 A Low cost yet robust with highly stable calibration and accuracy check facility A Solid-state Fleisch technology with no moving parts A Tested and certified to ATS/ERS:2005 Spirometry Guidelines A Uses standard size SafeTway disposable mouthpieces for assured hygiene A Fleisch technology flow sensor gives low back pressure A High visibility liquid crystal display with large numerals and icons Order Number: For high quality spirometry testing 19 20

13 Vitalograph Precision Syringe Spirometry guidelines jointly published by the European Respiratory Society and the American Thoracic Society advocate the use of a 3-L precision syringe for daily accuracy checks. Vitalograph has designed an extremely accurate, robust and lightweight 3-L precision syringe to give you the ultimate confidence in your spirometry measurements. A Available in 1-L and 3-L volumes A Accurate, robust and lightweight A Can be used with other manufacturers equipment. Adaptors may be required Order Number: Respiratory Disposables Vitalograph s wide range of respiratory consumables, which are designed to fit most respiratory devices, offer exceptional protection against cross infection, support effective spirometry and represent great value for money. PF Test Kits A White BVF Bacterial/Viral Filters, Bite-On Mouthpiece and Noseclip Order Number: A Clear BVF Bacterial/Viral Filters, Oval Mouthpiece, Noseclip and Elbow Order Number: For high quality spirometry testing 21 22

14 BVF Bacterial/Viral Filters Single use filters for effective filtration of bacteria, viruses and expectorated matter. Suitable for inspiratory and expiratory spirometry testing. SafeTway Mouthpieces Expiratory SafeTway Mouthpieces for use with Spirometers and PEF Meters A SafeTway Mouthpieces (200) A Blue BVF (50) Fits: Vitalograph Micromedical M.I.R A Teal BVF (50) Fits: MedGraphics Order Number: A Mini SafeTway Mouthpieces (50) Order Number: Order Number: Order Number: Bite-On Mouthpieces Order Number: A White BVF (50) Fits: Sensormedics PK Morgan Collins Order Number: A Green BVF (50) Fits: KoKo PDS nspire Fits all BVF filters except blue Cat No A Disposable Bite-On Mouthpiece Medium (50) Order Number: A Disposable Oval Mouthpiece (50) Order Number: Order Number: A Clear BVF (50) Fits: Jaeger Order Number: A Grey BVF (50) Fits: Chest Fukuda Minato Disposable Noseclips Fits all BVF filters except blue Cat No A Disposable Noseclips (200) Order Number:

15 Vitalograph Spirotrac Over-Read Service Spirotrac Over-Read Spirometry QA Service is a custom solution designed to utilise locally appointed and devolved expert over-reading to ensure that the quality of spirometry performed in general practice, occupational health and clinical trials meets acceptable and agreed standards. This sophisticated system enables prompt identification of shortfalls in spirometry quality arising from poor test acceptability, deficiencies in device accuracy or calibration, inappropriate use of test protocols or training issues. A Locally controlled, expert over-reading of primary care spirometry A Spirotrac Over-Read is provided as either a standard or customised service A Spirometry testing is conducted as normal A Spirometry session sent securely to your locally appointed over-reader or to Vitalograph appointed experts A Over-reader logs on to perform fast, efficient quality reviews A Tests accepted or rejected by the over-reader enabling prompt feedback (by exception) to users 25 26

16 Respiratory Clinical Trials Services As a global provider of respiratory related services Vitalograph has undertaken multi-centre clinical trials for many of the world's foremost pharmaceutical companies, biotechs and CROs. With a 50 year heritage of service in the respiratory field, and through our dedicated and motivated team of professionals, we bring the same commitment to excellence to all our clinical trials services. Our wide range of services includes: A Centralised spirometry with QA review A E-PEF/FEV1 Diaries A Project management A Data management A Customisation of software and manuals A Custom reports and web portals A Training of Monitors and Investigators A Site visits and 24/7 support A Translations A Protocol review Our Rigorous Systems & Processes We have developed a wide range of sophisticated systems and processes to protect the security and success of your trial including: A Mirrored data management system at a second Vitalograph location everything is automatically backed up and continues to operate seamlessly in the unlikely event that the primary system fails, with a generator taking over in the event of a mains electrical failure A Automatic data backup memory card in all site laptop PCs making it simple to change a PC in the event of a fault A Encrypted Internet data transmission system highly secure, fast and cost effective via local Internet Service Providers A Web-based access to data and reports a powerful tool for monitoring the progress of your study using VIEWER web portal Our Project Management Our project management expertise ensures that studies run to specification and schedule and that all steps involved in successful completion are conducted in a timely way with ongoing analysis and management of risks to GCP. Each study is assigned a dedicated Project Manager with several years experience in respiratory clinical trials. Project managers ensure that the following activities are tailored to suit the needs of each study: A Study Management of the respiratory data collection including liaison with, and reporting to, sites, monitors and sponsor teams A Spirometry Consultation including protocol enhancements, customisation specifications and user acceptance testing A Centralised Data Management with QA review service and provision of data sets to sponsors, CROs and EDC companies 27 28

17 AUSTRALIA Ph: Fax: UK Sales Vitalograph Ltd. Maids Moreton Buckingham MK18 1SW England Tel: Fax: Vitalograph GmbH Rellinger Straße 64a Hamburg Germany Tel: (040) Fax: (040) Export Sales Vitalograph Ltd. Maids Moreton Buckingham MK18 1SW England Tel: Fax: Vitalograph Inc West 99th Street Lenexa Kansas USA Tel: (913) Fax: (913) Vitalograph (Ireland) Ltd. Gort Road Business Park Ennis Co Clare Ireland Tel: (065) Fax: (065) Vitalograph, asma-1, copd-6, Pneumotrac, Spirotrac, In2itive, ALPHA, COMPACT, SafeTway and BVF are trademarks of Vitalograph Ltd. PRINT REF: 14629_1