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.