Mdoloris ANI MOC-9 User manual

MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020
ANI MOC-9
OEM version: ANI OEM v2.5
IHM version: 3.1.0.0
Instruction for use

MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020
©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.
Masimo is registered trademark.
MOC-9 is a registered trademark.
The Root Logo is a proprietary mark owned solely and exclusively by Masimo.
General knowledge of parasympathetic nervous system and an understanding of the
features and functions of the ANI MOC-9 are prerequisites for proper use.
These operating instructions intend to provide the necessary information for proper
operation of the ANI MOC-9.
Do not operate the ANI MOC-9 without completely reading and understanding these
instructions.
This User's Manual describes how ANI MOC-9 information is displayed when used
with Root®, including display details as well as accessing and changing user-
configurable settings. For additional information related to Root, refer to the
Operator's Manual for Root.
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
1370
First CE mark: 16/04/2019

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Contents
Contents................................................................................................................................3
Product Description.............................................................................................................5
Intended Use......................................................................................................................5
Contraindications................................................................................................................5
Warning and caution instructions.......................................................................................6
Safety warnings and cautions.............................................................................................6
Performance warnings and cautions...................................................................................8
Cleaning and service warnings and cautions......................................................................9
Compliance warnings and cautions ....................................................................................9
Chapter 1: Technology overview.......................................................................................11
Chapter 2: System description..........................................................................................12
Root 12
ANI MOC-9.......................................................................................................................13
ANI Sensor V1 PLUS .......................................................................................................13
Chapter 3: Setting Up ANI MOC-9 with ANI Sensors .......................................................14
Unpacking and inspecting the system...............................................................................14
Preparation for use...........................................................................................................14
Connecting the ANI Sensor V1 PLUS to the ANI MOC-9 module.....................................14
Connecting the ANI MOC-9 module..................................................................................15
Chapter 4: Operation..........................................................................................................17
The ANI MOC-9 window...................................................................................................17
Mode of operation.............................................................................................................19
Chapter 5: Trouble shooting..............................................................................................21
Chapter 6: Specifications...................................................................................................22
Environment.....................................................................................................................22
Physical Characteristics of the module.............................................................................22
Regulatory Symbols .........................................................................................................23
Conformity........................................................................................................................24
Chapter 7: Service and Maintenance ................................................................................25
Cleaning and disinfection..................................................................................................25
General maintenance .......................................................................................................25

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Service Instructions..........................................................................................................25
Repair Policy....................................................................................................................25
Warranty...........................................................................................................................26

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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.)

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Warning and caution instructions
Caution: read this entire manual carefully before using the ANI MOC-9 in a clinical
setting.
Safety warnings and cautions
Do not use the ANI MOC-9 if it appears or is suspected to be damaged.
Always use ANI MOC-9 in conjunction with Root. Do not use parts from other systems.
Injury to personnel or equipment damage could occur.
Do not adjust, repair, open, disassemble, or modify the ANI MOC-9. Injury to
personnel or equipment damage could occur.
Do not use ANI MOC-9 and the sensors during magnetic resonance imaging (MRI) or
in an MRI environment.
Explosion hazard: Do not use the ANI MOC-9 in the presence of flammable
anaesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
To protect against injury, follow the directions 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 MOC-9 while monitoring patient.
As with all medical equipment, carefully route patient cabling to reduce the possibility
of patient entanglement or strangulation.
Ground leakage current must be checked by a qualified biomedical engineering
technician whenever instrument case is opened.

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Protection against heart defibrillation shock depends on using the appropriate cables.
The conductive parts of sensors and connectors should not contact other conductive
parts, including earth.
To minimize the risk of patient burns from the neutral electrode for HF surgery, do not
put the ANI sensors between the surgical site and the electrosurgical unit's return
electrode.
Not place the ANI sensors between defibrillator paddles when they are use on a
patient connected to the ANI MOC-9.
Observe universal precautions to prevent contact with blood or other potentially
infectious materials. Contaminated materials must be handled in accordance with the
facility's applicable health and safety regulations.
Never modify the ANI MOC-9 when open.
Staff should avoid touching simultaneously patient and ANI MOC-9.
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.
In operating rooms, the ANI MOC-9 must be placed outside the explosion hazard
zone.
Reusing a sensor already used on another patient could lead to a risk of cross-
contamination.
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.

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Never put sensors on skin injuries.
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.
Reusing a sensor could reduce adhesion, leading to a possible decrease in ECG
signal acquisition performance.
Reusing a sensor could reduce its adhesive strength due to an initial application,
withdrawal and a new application.
Performance warnings and cautions
The ANI MOC-9 may be used during electrosurgery, but this may affect the accuracy
or availability of the parameters and measurements.
The ANI MOC-9 may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
The ANI MOC-9 may be used during defibrillation; however, the display may require
up to 15 seconds to return to normal operation.
The ANI MOC-9 is intended only as an adjunct device in patient 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.
Inaccurate ANI readings or no ANI readings may be caused by:
•Moisture on the skin.
•Excessive motion.
•Muscle activity
•Metal plate or other foreign object in sensor path.
•Electrosurgical interference.
•Improperly applied sensor.
•Adjacent placement of any sensor that is not connected to the same ANI
MOC-9.

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Cleaning and service warnings and cautions
Do not mix disinfecting solutions (e.g., bleach and ammonia), as toxic gases may
result.
Make sure the ANI MOC-9 is installed outside the liquid projections hazard zone, e.g.
Perfusion bag.
Do not autoclave the ANI MOC-9. Autoclaving will seriously damage both components.
Compliance warnings and cautions
When using electro-convulsive therapy (ECT) equipment during ANI monitoring: place
ECT sensors as far away as possible from the ANI sensor to minimize the effect of
interference. Some ECT equipment may interfere with the ANI MOC-9 signal. Check
for equipment compatibility during patient setup.
Using accessories and cables other than specified or provided by the manufacturer of
the ANI MOC-9 (Mdoloris Medical Systems) may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the ANI MOC-9 and may result in
an inappropriate operation.
The ANI MOC-9 complies with the electromagnetic compatibility requirements of EN
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.
The characteristics of ANI MOC-9 emissions allow it to be used in industrial areas and
hospitals (CISPR 11 class A). When used in residential environments (for which
CISPR 11 class B is required), ANI MOC-9 cannot guarantee provision of adequate

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protection of radio frequency communication. The user might need to perform
corrective actions, such as reimplantation or reorientation of the ANI MOC-9.
This medical equipment, its components and packaging must be recycled in
accordance with local regulations on the environment and disposal of electric waste.
Changes or modifications not expressly approved by Mdoloris Medical Systems shall
avoid the warranty for this equipment.

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Chapter 1: Technology overview
ANI (Analgesia Nociception Index) is a standardized continuous measurement of the relative
pΣ tone (parasympathetic tone). Each respiratory cycle (spontaneous and artificial) induces a
fast, temporary decrease of the pΣ 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 quantity" of pΣ 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 between 0 and 100. Each ANI value is computed on one time window
of 64 sec. This number shows the relative pΣ activity as a part of ANS activity: it expresses
the relative amount of pΣ tone present as compared to sum of sympathetic and pΣ activities.
ANI MOC-9 displays two averaged ANI measurements: ANIi results from the average of ANI
measured over the previous 56 sec, and ANIm results from the average of ANI measured
over the previous 176 sec.
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.

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Chapter 2: System description
The ANI MOC-9 system is composed of three (3) components:
• Root
• ANI MOC-9
• ANI Sensor V1 PLUS
Root
Root displays the following parameters:
•Instantaneous ANI
•Average ANI
•Quality of the measure
•Energy.
For more information about Root, see Operator’s Manual for Root.

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ANI MOC-9
The ANI MOC-9 computes ANI using signals acquired from the ANI Sensors. In turn, these
measurements are displayed on the Root.
ANI Sensor V1 PLUS
NOTE:
The ANI MOC-9 has been designed to work with specific disposable sensors. It is
inadvisable to use another kind of electrode.
The maximum consecutive period that the sensors can adhere to the skin is 24
hours.
The shelf life of the sensors is indicated on their 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, see the documentation provide with
the sensor.

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Chapter 3: Setting UpANI MOC-9 with ANI Sensors
For initial use of ANI MOC-9 module, the following setup instructions must be followed.
Unpacking and inspecting the system
1. Remove the components from the shipping carton and examine them for signs of
shipping damage.
2. Check all materials against the packing list. Save all packing materials, invoice and
bill of lading. These may be required to process a claim with the carrier.
3. If anything is missing or damaged, contact the Mdoloris Medical Systems Technical
Service Department.
Preparation for use
Prior to using ANI MOC-9 for monitoring
1. Confirm that you have all system components:
•Root
•ANI MOC-9
•ANI Sensor V1 PLUS
2. Confirm that Root holds adequate battery power.
Connecting the ANI Sensor V1 PLUS to the ANI MOC-9 module
1. Position the sensor as describe on the picture below.
Sensors’ positionning
2. Connect the sensors to the sensor cable.

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Before connecting, carefully align the notches on the connection sheet to make the pins
correspond perfectly. To disconnect the sensors, grasp the plastic portion while pressing on
the locking mechanism and pull gently to disengage it. Do not pull by grasping the
sensors itself.
Locking mechanism
Connecting the ANI MOC-9 module
1. Identify the Masimo Open Connect connector on the module, as illustrated in the
image below.
2. Insert the MOC-9 connector securely into a MOC-9 Port on Root, as illustrated in the
image below.
3. The module is now activated. This is verified when the ANI MOC-9 window displays
on Root.

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For more information on the ANI MOC-9 window, see The ANI MOC-9 Window section.

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Chapter 4: Operation
The following sections describe how ANI MOC-9 information is displayed when used with
Root, including display details. For additional information on Root, see Operator’s Manual for
Root.
The ANI MOC-9 window
When an ANI MOC-9 is connected to Root, ANI parameters and measurements display in
the ANI Module window as numeric values with graphical representation.
When multiple technologies are connected to Root, each technology’s parameters are
displayed in an individual window. The relative size of each window can be configured using
the Layout feature, which is accessible by pressing the Layout icon in the Main Menu. For
more information, see Operator's Manual for Root. In the image below, O3parameters and
measurements are displayed in their own windows; and ANI MOC-9 parameters and
measurements are displayed in a separate ANI Module window.

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The ANI module window shows information about measurement proceed by ANI MOC-9.
Four parameters are provided by the module:
•ANIi
•ANIm
•Quality
•Energy.
The window is composed by 2 slots:
1. slot with trend line and value of a selected parameter and,
2. slot with the values of the other parameters.
Only one trend can be displayed on the first slot. You can choose this parameter by dragging
and dropping the corresponding value from the slot 2 to the slot 1.
The window is outlined in the illustration and each part is explained in more detail in the table
below.
3
1
2
6
4
5

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Réf
Feature
Description
1
Slot 1
Displays the level and the value of the selected parameter
2
Slot 2
Displays the value of the other parameters
3
ANIm
Averaged value of the ANI between 0 and 100
4
ANIi
Instantaneous value of the ANI between 0 and 100
5
Energy
Energy of the RR series
6
Computation
quality
Quality of the measurement. Values ranging from 0 to1
•0 = bad quality
•1 = good quality
Mode of operation
Once the module is connected to the patient with the sensor and to the root, the calculation
algorithm will automatically begin.
Note: The ANI technology can be used with both conscious and unconscious patients,
whenever the physician wishes to use it.
ECG acquisition
Check for good computation in the lower part of the Root screen.
If the indication shows poor measurement quality (Value equal to 0) the data displayed
cannot be consider, the ANI index is not displayed anymore, the curve freezes. In that case,
check the proper position of the sensor and their adhesion to the skin. If necessary,
reposition or change them.
WARNING: always check the quality parameter. The ANI index will not be reliable if the
signal quality is bad.

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ANI index
We have developed calculation algorithms based on the amplitude measurement of the
respiratory modulation of RR interval time series.
A continuous index is displayed (each basic measurement is performed on 64 seconds of
data with a sliding window every second) that reflects the parasympathetic tone of the
patient. A calculation is made every second and then averaged over two time periods: a
short average (average on 56 seconds) and a longer average (average on 176 seconds).
The Root monitor displays two parameters: the orange one is the value of the longer average
(marked as “m”) and the yellow one is the instantaneous ANI (marked as “i”), resulting from
the short average. These indexes can anticipate a hemodynamic reactivity during the
nociceptive stimuli. “.