Vitalograph copd-6 4000, Instructions For Use Manual

Page 1: ...copd 6 Instructions for Use MODEL 4000 Copyright Vitalograph 2020 Current Edition Issue 1 28 Jan 2020 Cat No 09780...

Page 2: ...t vitalograph de Vitalograph Inc 13310 West 99th Street Lenexa Kansas 66215 USA Toll Free 800 255 6626 Tel 913 730 3200 Fax 913 730 3232 E mail contact vitalograph com www vitalograph com Technical Su...

Page 3: ...Vitalograph COPD 6 Early detection of COPD Displays FEV1 FEV6 ratio and predicted obstructive index COPD classification stage I IV and lung age Identifies risk of COPD at pre symptomatic stage Screens...

Page 4: ...lograph intends that a new Bacterial Viral Filter Eco BVF be used for every subject to prevent cross contamination Using a new Eco BVF provides a significant level of protection of the subject the dev...

Page 5: ...h the correct height Height increases decreases in values of 1 If the button is kept depressed the values scroll faster Press to save the height Note if height values are set below 100 the device assu...

Page 6: ...a Breathe in as deeply as possible b Hold the breath c Place the mouthpiece into the mouth biting the mouthpiece lightly and sealing the lips firmly around it d Blow out as HARD and FAST as possible...

Page 7: ...ssing again will toggle between best and last blow 13 Pressing the button shows the FEV6 and FEV6 Predicted results 14 Pressing the button again shows the FEV1 FEV6 and FEV1 FEV6 Predicted results 15...

Page 8: ...lour systems for each zone type are pre set as follows FEV1 Pred Obstructive Index COPD Classification FEV1 FEV6 Ratio and FEV Pred 80 0 Green Not COPD FEV1 FEV6 0 7 Top Boundary Stage I FEV1 FEV6 0 7...

Page 9: ...bottom boundary by pressing the or button and releasing when the value is reached The values increase decrease in values of 1 If the button is kept depressed the values scroll faster 8 Press to save...

Page 10: ...used Weekly cleaning of the mouthpiece outside surfaces and flowhead of the device is recommended A cloth impregnated with 70 isopropyl alcohol may be used The plastic mouthpiece may be washed in warm...

Page 11: ...ting up using or maintaining the device or to report unexpected operations or changes in performance contact Vitalograph using the contact information at the start of this manual Also contact the heal...

Page 12: ...product end of life Do not dispose of these products as unsorted municipal waste The pouch can be disposed of in unsorted municipal waste Used Eco BVFs and SafeTways constitute minimally soiled waste...

Page 13: ...evice Order Number Use by Date Date format yyyy mm dd Keep Dry Do not re use Non sterile Recycle QR code matrix bar code All information in the bar code is included in the text under it Other Labels B...

Page 14: ...ce displays some key parameters for clinical interpretation FEV1 and FEV1 Predicted FEV6 and FEV6 Predicted FEV1 FEV6 and FEV1 FEV6 Predicted If an abnormal result is indicated arrows on the display s...

Page 15: ...batteries Battery Life 3 months of use 3 tests per day Batteries near the end of their shelf life will have reduced capacity Bad Test Criteria Slow start of test Vext 5 or a cough detected in the firs...

Page 16: ...F be used for every subject to prevent cross contamination Using a new Eco BVF provides a significant level of protection of the subject the device and the user against the risk of cross contamination...

Page 17: ...enna cables and external antennas which emit electromagnetic fields should be used no closer than 30 cm 12 inches to any part of the device including cables specified by Vitalograph Otherwise degradat...

Page 18: ...The customer or the user of the COPD 6 should assure that it is not used in such an environment The Model 4000 COPD 6 has been tested in accordance with EN60601 1 2006 A1 2013 Medical electrical equi...

Page 19: ...tablishments EN 60601 1 2 Immunity tests Immunity test Test level Compliance level Reached Electrostatic discharge ESD EN 61000 4 2 Contact 8 kV Air 2 kV 4 kV 8kV 15 kV Contact 8 kV Air 2 kV 4 kV 8kV...

Page 20: ...nterference is suspected or possible switching off the offending device is the normal solution as is required in aircraft and medical facilities Medical electrical equipment needs special precautions...

Page 21: ...mended This device is classified as IIa per Annex IX of the MDD also meets the provisions of the Essential Requirements Annex I via compliance with Annex II of the Medical Devices Directive as per Art...

Page 22: ...akes to rectify at no expense to the customer any software failure notified within the period stated above provided that the failure can be recreated and the software has been installed and used in ac...

Page 23: ...y consequential damages arising out of the use of or inability to use any Vitalograph equipment 8 This Guarantee is offered as an additional benefit to the Consumer s statutory rights and does not aff...

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