Vitalograph - Lung monitor

Lung monitor

Vitalograph lung monitor is a easy to use home monitoring device which records lung function parameters

Easy to use device for monitoring of lung function parameters for those with respiratory conditions including cystic fibrosis and transplant patients. The lung monitor measures FEV1, FEV6 & the ratio with electronic and hard copy reports. The device is simple to use and stores over 200 test sessions.

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For simple, accurate lung function monitoring at home
Measures FEV1, FEV6 and the ratio
Displays % of personal best FEV1
Large, easy to read display
Electronic record – no need for record cards
Automatically stores best values in a test session
Quality of blow indicator
Easy to clean flowhead
Suitable for multi-subject use in clinic with SafeTway mouthpieces
Uses long life AAA batteries
Language independent
Meets ATS/ERS:2005 Spirometry Guidelines

Product	Vitalograph lung monitor
Model Number	4000
Part Number	40500, 40400, 40750, 40950
Description	Vitalograph lung monitor, Vitalograph lung monitor usb, Vitalograph lung monitor bluetooth, Vitalograph lung monitor serial
Parameters Displayed	FEV1, FEV6 , FEV1/FEV6 ratio and FEF
Memory	FEV1, FEV6 , FEV1/FEV6 ratio and FEF
Quality of Blow Indicator	Yes
Accuracy	Better than +/- 3%
Range	0 - 9.99 L BTPS
Sensor	Stator rotor
Flow Impedance	Better than 0.15 kPa/L/s at 14 L/s
Power Supply	AAA batteries
Display	Custom liquid crystal display
Size	113 x 63 x 48mm
Weight	55g net
Performance standards	ISO 26782:2009 ISO 23747:2007 ATS/ERS Guidelines 2005
Operating Temperature Range	17 - 37°C
Management Zones	Factory set 3 zones Green/Yellow threshold 95% Yellow/Red threshold 90% Zones may be changed by the user And number of zones increased to 4
Safety Standards	IEC 60601-1:2005
Medical Safety Standard	Medical Devices Directive 93/42/EEC
Designed and manufactured to following QA/GMP standards	ISO 13485:2003 FDA 21CFR820 CMDR

40550	Lung monitor
20242	2024 SafeTway Mouthpieces
20980	2024 Mini SafeTway Mouthpieces
20303	2030 Disposable NoseClips

Centralized 12-Lead Holter data can be collected via the Mortara H12, 12-Lead Holter Monitor. The H12+ is capable of recording 24-hours of ECG data on Compact Flash Cards. Holter data is transmitted to a central database via a web-based data transfer application eliminating the need to send cards via courier and minimizing any potential for data compromise. The holter data is reviewed in accordance with the requirements of the study protocol by trained cardiac experts. Holter test results are available to site/CRO/Sponsor staff via a web-based data reporting portal.

The BT-12 12-lead ECG enables Full 12-lead electrocardiography with very low occurrence of lead artefact. Analysis and interpretation come as standard using the world class University of Glasgow interpretation algorithm which provides detailed diagnostic suggestions and evaluation of results. ECG measurements are captured and transmitted wirelessly for display in real-time and data is automatically saved for recall, reporting or printing. Transmitting ECG traces wirelessly is fast and safe with no leads to trip over or create artefacts from movement or electrical sources. The built-in display provides information on electrode contact problems, heart rate, battery status, communication status and digital pacemaker detection. The 12-lead resting ECG data is reviewed in accordance with the requirements of the study protocol by trained cardiologists.

Operator controlled selection of a 10-s sample trace, but can capture and store several minutes of 12-lead ECG recording
Visual electrode contact indication to assist operator
Wireless data transmission via Bluetooth (range:approx. 10m)
High quality multi-channel and 12-lead overview for viewing and printing
Print configurable 1 or 2 page reports

View traces as 1 x 12; 2 x 6 or 3 x 4 plus rhythm strip
Calculation of the heart rate with acoustic and visual signal
Full range of parameters are available (e.g. P duration,PQ interval, QRS period)
Automatic pacemaker detection
Rhythm analysis