Mdoloris ANI Monitor V1 User manual

Continuous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020
Analgesia Nociception Index
ANI Monitor V1
User manual
Software version 1.1.4.0
(CE mark first approved on April 2012)
MDOLORIS MEDICAL SYSTEMS SAS
Biocentre Fleming
Bâtiment C Epi de Soil
270 rue Salvador Allende
59120 LOOS (France)
Tel: [phone] - Fax: [phone]
www.mdoloris.com

Continuous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.14 - 12 MAR 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.
Important information about using the continuous analgesia
monitoring system:
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 system is intended
for use on adult and pediatric patients, in a facility providing patient
care by monitoring parasympathetic nervous tone activity.
The continuous analgesia monitoring system may be used to
monitor the effects of certain analgesic agents.
The Analgesia Nociception Index (ANI) is a complex monitoring
technology 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. As with any monitored parameter, artifacts and poor
signal quality may lead to inappropriate ANI values. Potential
artifacts may be caused by muscle activity or rigidity, patient
motion, improper sensor placement or electrical interference. The
essential performance identified for the ANI Monitor V1 is the
display of ANI index if the signal quality is good.
The ANI Monitor V1 needs special precautions regarding
environments. The ANI Monitor V1 has to be installed and put into
service in hospitals and away from the RF source magnetic
resonance imaging.
ANI is a protected trademark.

ANI Monitor V1 - Continuous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.12 - 08 MAR 2019
Contents
1Safety precautions .........................................................................................................1
1.1 Warning....................................................................................................................1
1.2 Caution.....................................................................................................................6
1.3 Notes ........................................................................................................................8
1.4 Key to symbols.........................................................................................................8
2ANI Monitor V1 ............................................................................................................9
3Installing the ANI Monitor V1....................................................................................11
3.1 Perfusion stand .......................................................................................................11
3.2 ANI Sensor V1 / ANI Sensor V2 / ANI Sensor V1 PLUS .......................................11
3.3 ANI Monitor V1 connection ...................................................................................13
3.4 Battery....................................................................................................................14
4Beginning ANI Monitoring .........................................................................................15
5Using the ANI Monitor V1 and setting parameters ...................................................17
5.1 ECG Capture ..........................................................................................................17
5.2 Respiratory pattern..................................................................................................18
5.3 ANI index...............................................................................................................19
5.4 ANI navigation.......................................................................................................19
6ANI Monitor V1 settings.............................................................................................20
6.1 Language parameters ..............................................................................................20
6.2 Threshold................................................................................................................20
6.3 Events.....................................................................................................................23
6.4 Expert mode and Energy index ...............................................................................23
7Ending ANI monitoring ..............................................................................................26
7.1 Stopping the recording of a case..............................................................................26
7.2 Demo......................................................................................................................27
7.3 New patient.............................................................................................................27
7.4 Maintenance ...........................................................................................................27
7.5 Deleting patient data...............................................................................................27
7.6 Screen capture ........................................................................................................28
7.7 Exporting data files.................................................................................................29
7.8 Updating events......................................................................................................30
7.9 Setting date and time...............................................................................................31
7.10 Updating monitor....................................................................................................32
7.11 Shutting down.........................................................................................................34
8Trouble shooting..........................................................................................................34

ANI Monitor V1 - Continuous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.12 - 08 MAR 2019
9Monitor disposal..........................................................................................................36
10 Environment................................................................................................................36
10.1 Shipping and storage conditions..............................................................................36
10.2 Operating Environment...........................................................................................37
10.3 Power requirements and grounding.........................................................................37
11 Cleaning and disinfection............................................................................................38
11.1 Cleaning .................................................................................................................38
11.2 Maintenance ...........................................................................................................39
12 Specifications, warranty and software license contract.............................................39
12.1 Specifications .........................................................................................................39
12.2 Warranty.................................................................................................................41
12.3 Software License Agreement ..................................................................................43

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MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020
1Safety precautions
INTRODUCTION
Caution: read this entire manual carefully before using the monitor in a clinical setting.
WARNING
A warning advises against certain actions or situations that could result in physical injury or
death. Accidents may result from the inability to avoid a hazardous situation. This is why it is
important to follow the instructions in these warnings, to prevent personal injury.
CAUTION
A caution advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure, when personal injury is unlikely.
NOTE
A note provides useful information regarding a function or procedure.
KEY TO SYMBOLS
A key to the symbols that may appear on the ANI Monitor V1 appears at the end of this
section.
1.1 Warning
GROUND LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED
BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS
OPENED.
PROTECTION AGAINST HEART DEFIBRILLATION SHOCK DEPENDS ON USING
THE APPROPRIATE CABLES.

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MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020
EXPLOSION HAZARD: DO NOT USE THE ANI Monitor V1 IN A FLAMMABLE
ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS
MAY OCCUR.
NEITHER THE MONITOR NOR THE ELECTRODES ARE DESIGNED FOR USE IN A
MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENT.
THIS ANI Monitor V1 CANNOT BE IN ANY CASE CONSIDERED AS AN ECG
MONITORING SYSTEM.
WHEN USING ELECTRO-CONVULSIVE THERAPY (ECT) EQUIPMENT DURING
ANI MONITORING: place ECT electrodes as far away as possible from the sensor to
minimize the effect of interference. Some ECT equipment may interfere with the ANI
Monitor V1 signal. Check for equipment compatibility during patient setup.
ONLY USE THE POWER CORD SUPPLIED BY THE MANUFACTURER. NEVER
ADAPT THE PLUG FROM THE MONITOR TO FIT A NON-STANDARD OUTLET.
IF THE INTEGRITY OF GROUNDING IS IN DOUBT, DO NOT USE THE ANI Monitor
V1.
BE SURE THE MONITOR IS INSTALLED SECURELY TO AVOID INJURY TO
PERSONNEL OR PATIENTS.

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MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE GROUND LEAKAGE SYSTEM CURRENT MUST BE CHECKED
AND MUST BE LESS THAN THE IEC 60601-1 LIMIT.
USING ACCESSORIES AND CABLES OTHER THAN SPECIFIED OR PROVIDED BY
THE MANUFACTURER OF THE ANI Monitor V1 (MDOLORIS MEDICAL SYSTEMS)
MAY RESULT IN INCREASED ELECTROMAGNETIC EMISSIONS OR DECREASED
ELECTROMAGNETIC IMMUNITY OF THE ANI Monitor V1 AND MAY RESULT IN
AN INAPPROPRIATE OPERATION.
CONSIDERATION RELATING TO THE CHOICE OF EQUIPMENT SHALL
INCLUDE:
- EVIDENCE THAT USING THE ACCESSORY IN THE PATIENT VICINITY AND OR
SURGERY VICINITY IS COMPLIANT
- EVIDENCE THAT THE ACCESSORY'S "CE" SAFETY CERTIFICATION
COMPLIES WITH STANDARD (IEC 60601-1) AND THAT THE ACCESSORY IS
COMPATIBLE WITH THE ANI Monitor V1
TO AVOID PATIENT INJURY DUE TO HIGH SURFACE TEMPERATURE, DO NOT
PLACE THE INTERFACE EQUIPMENT DIRECTLY IN CONTACT WITH SKIN.
THE CONDUCTIVE PARTS OF ELECTRODES OR 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 ELECTRODES BETWEEN THE
SURGICAL SITE AND THE ELECTROSURGICAL UNIT'S RETURN ELECTRODE.

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ENSURE PROPER CONTACT OF THE ELECTROSURGERY RETURN ELECTRODE
TO AVOID POSSIBLE BURNS ON THE PATIENT VIA ANI ELECTRODES.
THE CHARACTERISTICS OF ANI Monitor V1 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 Monitor V1 CANNOT GUARANTEE PROVISION OF ADEQUATE PROTECTION
OF RADIO FREQUENCY COMMUNICATION. THE USER MIGHT NEED TO
PERFORM CORRECTIVE ACTIONS, SUCH AS REIMPLANTATION OR
REORIENTATION OF THE ANI Monitor V1.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE MUST BE CAREFULLY PLACED AND SECURED.
DO NOT PLACE THE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADDLES
WHEN THEY ARE USE ON A PATIENT CONNECTED TO THE ANI Monitor V1.
REUSING A SENSOR ALREADY USED ON ANOTHER PATIENT COULD LEAD TO
CROSS-CONTAMINATION.
IF THE PATIENT DEVELOPS A SKIN REACTION OR OTHER UNUSUAL
SYMPTOMS, REMOVE THE ELECTRODES. IT IS IMPORTANT TO TAKE
PARTICULAR CARE WITH PATIENTS SUFFERING FROM DERMATOLOGICAL
PROBLEMS.
NEVER PUT ELECTRODES ON SKIN INJURIES.

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ELECTRICAL SHOCK:
-DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET
HANDS.
-DO NOT REMOVE MONITOR COVERS DURING OPERATION OR WHILE
POWER IS CONNECTED TO MONITOR.
-THE MANUFACTURER'S INSPECTION OF THIS APPARATUS VERIFIED
THAT THE GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY
CURRENT WERE BELOW THE LIMITS SPECIFIED BY THE APPLICABLE
SAFETY STANDARDS. AS A MATTER OF SAFE PRACTICE, THE FACILITY
MUST CONDUCT TESTS TO VERIFY THESE CURRENTS ESPECIALLY
WHEN A BIOMEDICAL ENGINEERING TECHNICIAN PERIODICALLY
PERFORMS MAINTENANCE.
WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR LIQUIDS
OCCURS ON THE ANI Monitor V1, RE-TEST GROUND LEAKAGE CURRENT
BEFORE FURTHER USE.
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.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA), AS
TOXIC GASES MAY RESULT.
THE ANI Monitor V1 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

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- CONTACT YOUR MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE.
IN OPERATING ROOMS THE ANI Monitor V1 MUST BE PLACED OUTSIDE THE
EXPLOSION HAZARD ZONE.
MAKE SURE THE MONITOR IS INSTALLED OUTSIDE THE LIQUID PROJECTIONS
HAZARD ZONE, E.G. PERFUSION BAG.
NEVER MODIFY THE MONITOR WHEN OPEN.
USE OF ANI Monitor V1 ADJACENT TO OR STACKED WITH OTHER EQUIPMENT
SHOULD BE AVOIDED BECAUSE IT COULD RESULT IN IMPROPER OPERATION.
IF SUCH USE IS NECESSARY, THIS EQUIPMENT AND THE OTHER EQUIPMENT
SHOULD BE OBSERVED TO VERIFY THAT THEY ARE OPERATING NORMALLY.
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 Monitor V1,
INCLUDING CABLES SPECIFIED BY THE MANUFACTURER. OTHERWISE,
DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT COULD RESULT.
1.2 Caution
Read this entire manual carefully before using the monitor in a clinical setting.
Before starting, ensure there are no USB devices (USB sticks for example) connected to
the monitor.
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.