Mdoloris ANI-MR User manual

MD/PRD/IN16.ANIMR V.04 – 14/12/2021
ANI-MR
ANI computation version: ANI OEM v2.8
ECG processing version: 3.1.0.0
Instruction for use

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©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.
The MDoloris Medical Systems continuous analgesia monitoring system is intended
for use in a medical environment and under the direct supervision of a licensed
healthcare practitioner or by personnel specifically trained for its use. The essential
performance identified for the ANI-MR is the display of ANI index if the signal quality
is good.
General knowledge of parasympathetic nervous system, an understanding of the
features and functions of the ANI-MR are prerequisites for proper use.
This instructions for use intend to provide the necessary information for proper
operation of the ANI-MR.
Do not operate the ANI-MR without completely reading and understanding these
instructions.
This user's manual describes how ANI-MR information is displayed when used with
BeneVisionTM monitor (N22/N19/N17/N15/N12/N12C), including display details as
well as accessing and changing user-configurable settings. For additional
information related to BeneVision TM monitor, refer to the instruction of use for
BeneVision TM.
For further information contact:
MDOLORIS MEDICAL SYSTEMS SAS
Biocentre Fleming
Bâtiment C - Epi de Soil
270, rue Salvador Allende
59120 LOOS
Tel: [phone] - Fax: [phone]
www.mdoloris.com

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Summary
Summary .................................................................................................................. 5
About this manual ................................................................................................... 7
Product Description ................................................................................................ 8
Intended Use ....................................................................................................... 8
Indication for use ................................................................................................. 9
Contraindications ................................................................................................. 9
Side-effects ......................................................................................................... 9
Warning and cautions ........................................................................................... 10
Safety warnings and cautions ........................................................................... 10
Performance warnings and cautions ................................................................. 12
Cleaning and service warnings and cautions .................................................... 13
Compliance warnings and cautions ................................................................... 13
Chapter 1: Technology overview ......................................................................... 15
Chapter 2: System description ............................................................................ 17
BeneVisionTM monitor ........................................................................................ 17
Mindray ANI single slot communication module ................................................ 18
ANI-MR 18
ANI Sensor V1 PLUS ........................................................................................ 19
Chapter 3: Setting Up ANI-MR with ANI Sensors ............................................... 20
Unpacking and inspecting the system ............................................................... 20
Preparation for use ............................................................................................ 20
Connecting ANI Sensor V1 PLUS to the ANI-MR module ................................ 21
Connecting the ANI-MR module ........................................................................ 22
Chapter 4: Operation ............................................................................................ 24
The ANI-MR window ......................................................................................... 24
Mode of operation ............................................................................................. 25
Chapter 5: Troubleshooting ................................................................................. 27

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Chapter 6: Specifications ..................................................................................... 29
Performance Characteristics ............................................................................. 29
Environmental specifications ............................................................................. 30
Mechanical specifications .................................................................................. 31
Electrical specifications ..................................................................................... 31
Regulatory Symbols .......................................................................................... 32
Conformity ......................................................................................................... 34
Chapter 7: Service and Maintenance .................................................................. 35
Cleaning and disinfection .................................................................................. 35
General maintenance ........................................................................................ 35
Repair Policy ..................................................................................................... 36
Warranty 37
Software License Agreement ............................................................................ 38

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About this manual
This manual explains how to set and use the ANI-MR. Important
safety instructions for the general use of the ANI-MR are presented in
this manual. Read and observe all warnings throughout this manual.
The following information is a security explanation and warning.
A warning is given when an action may result in a serious outcome
(e.g. injury, serious adverse reaction, death) for the patient or user.
WARNING : this is an example of a warning.

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Product Description
In partnership with Shenzhen Mindray Bio-Medical Electronics,
MDoloris Medical Systems has developed the ANI-MR device for the
supervision and monitoring of patients with the BeneVisionTM Mindray
monitor. Connecting the ANI-MR module on the BeneVisionTM monitor
allows the visualization of the ANI index.
The ANI-MR device and its sensors are designed to be used for adult
patients and for paediatric patients from 12 years old.
ANI-MR is intended for use under the direct supervision of a licensed
healthcare practitioner or by personnel specifically trained for its use
(anaesthesiologist-resuscitators and anaesthesiologists nurses) in a
medical environment.
Intended Use
ANI-MR allows the 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-MR is intended for use as a complement to clinical judgment.
Clinical judgment should always be used when interpreting the ANI
index in conjunction with other available clinical signs.
WARNING: Reliance on ANI alone for interpreting analgesic
management is not recommended.

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Indication for use
Clinical benefits are as follows:
• Predictivity of haemodynamic reactivity
• Better than rate and blood pressure variations to detect
nociception
• Helpful to diagnose the aetiology of a haemodynamic event
• Refines opioids titration
• Reduces per-operative opioid consumption
• Reduces post-operative pain
• Predicts post-extubation pain
• Reduce length of stay in outpatient surgery units
Contraindications
ANI measures cannot be performed in case of:
• Arrhythmia or heart rate out of the range 30 – 150 bpm
• Apnoea (e.g., apnoea induced by anaesthesia)
• Respiratory rate lower than 9 cycles/min or higher than 30
• Electric noise during the measurement period (64 seconds)
• Irregular spontaneous ventilation (patient speaking, laughing,
or coughing)
• Pacemaker (some types)
• Heart transplant
• Drugs affecting the sinus node (atropine and other
anticholinergic drugs, etc.)
Side-effects
No undesirable side-effects up to date, the use of the sensor with the
ANI-MR may lead to undesirable side-effects. Please refer to Sensor
Manual for more information.

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Warning and cautions
Caution: read this entire manual carefully before using the ANI-
MR in a clinical environment.
Safety warnings and cautions
WARNING : Do not use the ANI-MR if it appears or is suspected to be
damaged.
WARNING : Always use ANI-MR in conjunction with BeneVisionTM
monitor. Do not use parts from other systems. Injury to personnel or
equipment damage could occur.
WARNING : Always use ANI-MR with device compliant with 60601-1
and CF type applied parts.
WARNING : Do not adjust, repair, open, disassemble, or modify the
ANI-MR. Injury to personnel or equipment damage could occur.
WARNING : Do not use ANI-MR and the sensors during magnetic
resonance imaging (MRI) or in an MRI environment.
WARNING : Explosion hazard: Do not use the ANI-MR in the presence
of flammable anaesthetics or other flammable substance in
combination with air, oxygen-enriched environments, or nitrous oxide.
WARNING : To protect against injury, follow the instructions below:
• Avoid placing the device on surfaces with visible liquid
spills
• Do not soak or immerse the device in liquids
• Use cleaning solutions only as instructed in this User’s
Manual
• Do not attempt to clean ANI-MR while monitoring patient.
WARNING : As with all medical equipment, carefully route patient
cabling to reduce the risk of patient entanglement or strangulation.
WARNING : Ground leakage current must be checked by a qualified
biomedical engineering technician whenever the instrument case is
opened.