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.

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WARNING : Protection against heart defibrillation shock depends on
the use of appropriate cables.
WARNING : The conductive parts of sensors and connectors should
not contact other conductive parts, including earth.
WARNING : To minimize the risk of patient burns from the neutral
electrode using a diathermy knife, do not put the ANI sensors between
the surgical site and the electrosurgical unit's return electrode.
WARNING : Not place the ANI sensors between defibrillator paddles
when they are used on a patient connected to the ANI-MR.
WARNING : Observe universal precautions to prevent any contact
with blood or other potentially infectious materials. Contaminated
materials must be handled in accordance with the facility's applicable
health and safety regulations.
WARNING : Never modify the ANI-MR when opened.
WARNING : The staff should avoid touching simultaneously patient
and the ANI-MR.
WARNING : The patient should not be able to reach the equipment
directly or indirectly; avoid for instance placing equipment on top of
another equipment with a metal casing.
WARNING : In operating rooms, the ANI-MR must be placed outside
the explosion hazard zone.
WARNING : Reusing a sensor already used on another patient could
lead to a risk of cross-contamination.
WARNING : If the patient develops a skin reaction or other unusual
symptoms, remove the sensors. It is important to take particular care
with patients suffering from dermatological problems.
WARNING : Never put sensors on skin injuries.
WARNING : Using sensors other than those specified by MDoloris
Medical Systems can damage the device or result in a risk of harm to
the user or the patient.
WARNING : Reusing a sensor could reduce adhesion, leading to a
possible decrease in ANI input signal acquisition performance.
WARNING : Reusing a sensor could reduce its adhesive strength due
to an initial application, removal, and a new use.

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WARNING : Protect the ANI-MR against sudden temperature changes
that could lead to condensation inside the device.
WARNING : To minimize condensation, avoid moving the system
between heated buildings and outside storage. Once moved inside,
allow the ANI-MR to stabilize in the unopened shipping container at
room temperature before unpacking and placing into service.
WARNING : Before operating the system, wipe down all visible
condensation and allow the system to reach equilibrium at room
temperature.
WARNING : The ANI-MR is not designed for use in areas containing
flammable gases or vapours.
WARNING : Do not pull on the patient cable, it may tear and you will
no longer be able to use it.
WARNING : Do not pull on the communication cable, it may tear and
you will not be able to use it anymore.
Performance warnings and cautions
WARNING : The ANI-MR may be used during electrosurgery, but this
may affect the accuracy or availability of the parameters and
measurements.
WARNING : The ANI-MR may be used during defibrillation, but this
may affect the accuracy or availability of the parameters and
measurements.
WARNING : The ANI-MR may be used during defibrillation; however,
the display may require up to 15 seconds to return to normal
operation.
WARNING : The ANI MR is intended only as an adjunct device in the
patient’s assessment. It should not be used as the sole basis for
diagnosis or therapy decisions. It must be used in conjunction with
clinical signs and symptoms.

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WARNING : Inaccurate ANI readings or no ANI readings may be
caused by:
• Moisture on the skin
• Excessive motion
• Muscle activity
• Metal plate or another foreign object in sensor path
• Electrosurgical interference
• Sensor improperly applied
• Adjacent placement of any sensor that is not connected
to the same ANI-MR.
Cleaning and service warnings and cautions
WARNING : Do not mix disinfecting solutions (e.g., bleach and
ammonia), as toxic gases may result.
WARNING : Make sure the ANI-MR is installed outside the liquid
projections hazard zone (e.g., Perfusion bag).
WARNING : Do not autoclave the ANI-MR. Autoclaving will seriously
damage the components.
WARNING : To avoid any kind of contamination or infection of the
personnel, the environment or equipment, be sure you have properly
disinfected and decontaminated the ANI-MR before you dispose of
your system. Respect local regulations regarding electric and
electronic items.
WARNING : Do not throw the device into the household trash, see
the procedure at the end of the user manual.
Compliance warnings and cautions
WARNING : When using electro-convulsive therapy (ECT) equipment
during ANI monitoring: place ECT sensors as far as possible from the
ANI sensor to minimize the effect of interferences. Some ECT
equipment may interfere with the ANI-MR signal. Check the
equipment compatibility during patient preparation.

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WARNING : Using accessories and cables other than specified or
provided by the manufacturer of the ANI-MR (MDoloris Medical
Systems) may result in increased electromagnetic emissions or
decreased electromagnetic immunity of the ANI-MR and may result in
an inappropriate operation.
WARNING : The ANI-MR complies with the electromagnetic
compatibility requirements of IEC 60601-1-2. Operation of this device
may affect or be affected by other equipment in the vicinity due to
electromagnetic interference (EMI). If this occurs:
• Increase separation between devices
• Change the orientation of device cabling
• Plug devices into separate outlets
• Contact your MDoloris Medical Systems
representative
WARNING : The use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in an
improper operation. If such use is necessary, this equipment should
be observed to verify that it operates normally.
WARNING : The use of accessories, transducers, and cables other
than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in
an improper operation.
WARNING : Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the ANI-MR,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
WARNING : This medical equipment, its components and packaging
must be recycled in accordance with local regulations on the
environment and disposal of electric waste.
WARNING : Changes or modifications not expressly approved by
MDoloris Medical Systems shall avoid the warranty for this
equipment.
WARNING : The use of the monitor cannot be done without prior
training. If training is needed, please contact your MDoloris Medical
Systems interlocutor.

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Chapter 1: Technology overview
ANI (Analgesia Nociception Index) is a standardized continuous
measurement of the relative pΣ tone (parasympathetic tone).
The ANI technology is intended to acquire and analyse
electrocardiographic information and to measure heart rate variability.
ANI calculation is based on R-R interval variability in ECG. Since the
monitors are not an ECG monitor, the ANI Sensor products have been
designed to retrieve information related to QRS complexes. The
acquisition of cardiac vector is enough to get an ANI calculation.
Each respiratory cycle (spontaneous and artificial) induces a fast,
temporary decrease of the parasympathetic tone, which accounts for
Respiratory Sinus Arrhythmia, and leads to a transient shortening of
the R-R intervals (increased heart rate). ANI quantifies these
“respiratory patterns” in order to measure the “relative quatity” of
parasympathetic tone.
The series of normal, non-ectopic, R-R intervals is processed after
normalization, resampling and filtering. The amount of pΣ tone is
measured in relation to the total window surface through the area
comprised between the lower and the upper envelope of the RR series.
The higher the pΣ, the higher the shaded surface is, and reciprocally.
The ANI is expressed and displayed on a scale of 0 and 100. However,
the lower limit attainable is 12 due to the algorithm design. The raw
ANI value is computed on a time window of 64 sec. This number shows
the relative parasympathetic activity as a part of ANS activity: it
expresses the relative amount of parasympathetic tone present as
compared to sum of sympathetic and parasympathetic activities.
ANI-MR provides two averaged ANI measurements: ANIi results from
the average of the raw ANI measured over the previous 56 sec, and
ANIm results from the average of the raw ANI measured over the
previous 176 sec.

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There are multiple ways of interpreting an ANI value. One is
probabilistic, as this index has been developed in order to predict
hemodynamic reactivity during nociceptive stimulation. When surgical
stimulation was constant, all hemodynamic reactivity episodes (20%
increase of heart rate or systolic blood pressure compared to a
reference) were associated with a decreased ANI up to 10 min
beforehand. The predictive thresholds need yet to be established, but
preliminary studies suggest:
- That an ANIm measure between 50 and 70 during surgery
makes a hemodynamic reactivity episode unlikely in the
following 10 minutes.
- That an ANIm lower than 50 makes hemodynamic reactivity
very likely in the following 10 minutes.
In the particular context of surgery under general anaesthesia or
intensive care unit:
- ANIm is related to the imbalance between analgesia and
nociception
- ANIi is related to the acute parasympathetic response to
stimulus
- Energy is an index related to the amount of total ANS activity
a short period (64 second).

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Chapter 2: System description
The use of the ANI-MR involves:
• BeneVisionTM Mindray monitor
• Mindray ANI single slot module
• ANI-MR module
• ANI Sensor V1 PLUS
BeneVisionTM monitor
BeneVisionTM monitor displays the following parameters:
• ANIi (Instantaneous)
• ANIm (Averaged)
• Energy
The ANI-MR is compatible with the N22/N19/N17/N15/N12/N12C
BeneVisionTM monitor from Mindray.
For more information about the Mindray monitor, please read
Operator’s Manual for BeneVisionTM monitor.

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Mindray ANI single slot communication module
This Mindray ANI single slot communication module allows you to
obtain the ANI data through the connection between the ANI-MR
module and the Mindray monitor.
ANI-MR
The ANI-MR computes the ANI with signals acquired from the ANI
Sensors. In turn, these measurements are displayed on the
BeneVisionTM monitor.
Connection to
Mindray monitor
Connection to the ANI
Sensor V1 PLUS

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ANI Sensor V1 PLUS
NOTE:
The ANI-MR has been designed to work with specific
disposable sensors. It is inadvisable to use another kind
of electrode.
The sensors can adhere to the skin for a maximum
period of 24 hours.
The shelf life of the sensors is indicated on the
packaging.
The ANI Sensor V1 PLUS allows the acquisition of signal in order to
process the algorithm.
For more information about the ANI Sensor V1 PLUS, please read
User’s manual of ANI V1 PLUS sensors.

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Chapter 3: Setting Up ANI-MR with ANI Sensors
For initial use of ANI-MR module, the following setup instructions must
be followed.
Unpacking and inspecting the system
1. Remove the components from the shipping box and
examine them to find signs of shipping damage.
2. Check that all materials listed on the packing list are
present. Keep all packing materials, invoice. These may be
required to process a claim with the carrier.
3. If any element is missing or damaged, contact the MDoloris
Medical Systems Technical Service.
Preparation for use
Prior to using ANI-MR for monitoring:
1. Check that you have all system components:
• BeneVisionTM Mindray monitor
• Mindray ANI single slot communication module
• Module ANI-MR
• ANI Sensor V1 PLUS
2. Check that BeneVisionTM monitor has a sufficient battery
power level.