User's Manual

7
The VENDYS® device is intended for use by competent healthcare professionals in
a clinical or research setting. It is intended to supplement, not substitute for, the
physician’sdecision making process, and it should be used inconjunction with the
patient’s history and other clinical findings.
Preparation and Optimal Conditions for VENDYS Test
Factors affecting vascular reactivity:
Ambient temperature
Time from food intake
Drugs
Sympatheticstimuli
Subjects preparation:
Rest for at least 6 hours before the TEST
Do not exercise for 6 hours before test
Do not exercise during the test
Betestedina quiet, temperature-controlled room
Withhold all vasoactive medications forat leastfourhalf-lives
Do not ingest substances that might affect vascular reactivity such as caffeine,
high-fat foods and vitamin C or use tobacco for at least 4 to 6 hours before the
test
Theoperatorshould be cognizantof thephase of the subject'smenstrual cyclewhich
mayaffect the response. These confoundingfactorsmust be considered inpreparinga
subjectforstudiesthat seek to determine the impactof asingle intervention.
Forobservationalcohortstudies, datamust be collected onthose factorsknown to
affectthemeasurementof response, and analysisshould addresstheirimpact.
Environmental Conditions:
Ambient roomtemperature should be keptconstant at/around 24°C.Bright lights,
movementofother people, fans, direct sunlight,or beingseated near an ACventmay
cause mental stressand affectthetestresults, sotheyshould beavoided. It may be
helpful todimthelightsor have the patient wearingheadphones. The
environmentshould be calmandstable.
VENDYS Assembly Instruction
Introduction to theJK001V device