MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020
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Product Description
In partnership with Masimo Corporation, Mdoloris Medical Systems has developed ANI
MOC-9 for a connectivity platforms and patient monitoring: Root monitor. By connecting the
ANI MOC-9 on the Root monitor from Masimo, it allows the visualization of the ANI index.
The Mdoloris Medical Module ANI MOC-9 and its sensors are designed to be used for adult
and paediatric patients from the age of 12 years.
ANI MOC-9 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 nurse anaesthetists) in a medical environment.
Intended Use
ANI MOC-9 allows monitoring of the tone of the parasympathetic nervous system by
computing the ANI parameter for conscious and unconscious patients. It may be used to
monitor the balance between analgesia and nociception.
ANI MOC-9 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.
Contraindications
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.)