ANI Monitor V2 - Continuous analgesia monitoring system
MD/PRD/IN16.ANIV2 v.07 - 12 MAR 2020
©Mdoloris Medical Systems. All rights reserved. Copying or other reproduction of this
document is prohibited without prior written consent of Mdoloris Medical Systems.
Mdoloris Medical Systems is registered trademark.
ANI is a protected trademark.
Important information about the intended use of ANI Monitor V2:
The
Mdoloris Medical Systems’ ANI Monitor V2 is designed to be used for adult and
paediatric patients from the age of 2 years.
ANI Monitor V2 is intended for use under the direct supervision of a licensed
healthcare practitioner or by personnel specifically trained for its use (resuscitators,
anaesthesiologists, state-registered nurses anaesthetists) in a medical environment,
non-sterile.
ANI Monitor V2 allows monitoring the tone of the parasympathetic nervous system.
It may be used to monitor the effects of certain analgesic agents.
ANI Monitor V2 is intended for use as an adjunct to clinical judgment.
Clinical judgment should always be used when interpreting the ANI index in
conjunction with other available clinical signs.
Reliance on ANI alone for interpreting analgesic management is not recommended. As
with any monitored parameter, artifacts and poor signal quality may lead to
inappropriate ANI values. Potential artifacts may be caused by muscle activity or
rigidity, patient motion, improper sensor placement or electrical interference.
Known contraindications where the ANI measurement cannot be interpreted:
•
arrhythmia
•
apnea (e.g. apnea induced by anesthesia)
•
respiratory rate lower than 9 cycles/min
•
electric noise during the measurement period (64 seconds)
•
irregular spontaneous ventilation (patient speaking, laughing or coughing)
•
pace maker (certain types)
•
heart transplant
•
drugs affecting the sinus node (atropine and other anticholinergic drugs, etc.)
