Mdoloris ANI MONITOR V2 User manual

ANI Monitor V2 - Continuous analgesia monitoring system
MD/PRD/IN16.ANIV2 v.07 –29 SEP 2021
User manual
ANITechnology
ANI MONITOR V2
Software version: 2.2.2.0
1370
(CE mark first approved: February 2017)
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

ANI Monitor V2 - Continuous analgesia monitoring system
MD/PRD/IN16.ANIV2 v.07 –29 SEP 2021
©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.
Important information about the intended use of ANI MONITOR V2:
The Mdoloris Medical Systems’ ANI MONITOR V2 is designed to be used for adult and
paediatric patients from the age of 2 years.
ANI MONITOR V2 is intended for use under the direct supervision of a licensed
healthcare practitioner or by personnel specifically trained for its use in a medical
environment and non-sterile.
ANI MONITOR V2 allows monitoring the tone of the parasympathetic nervous system
on conscious patient.
It may be used to monitor the effects of certain analgesic agents.
ANI MONITOR V2 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. 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.
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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Contents
1Safety precautions......................................................................................................... 5
1.1 Warnings and safety instructions............................................................................ 5
1.2 Key to symbols......................................................................................................... 10
2ANI MONITOR V2.......................................................................................................... 11
3Installating the ANI MONITOR V2 ............................................................................ 11
3.1 Perfusion stand........................................................................................................ 11
3.2 Table.......................................................................................................................... 11
3.3 ANI-SENS-V1........................................................................................................... 12
3.4 ANI MONITOR V2 Connection.............................................................................. 13
4Beginning ANI monitoring V2................................................................................... 14
5Using the ANI MONITOR V2 and setting parameters......................................... 16
5.1 ECG Capture............................................................................................................ 16
5.2 Respiratory pattern.................................................................................................. 17
5.3 ANI index.................................................................................................................. 18
5.4 ANI navigation.......................................................................................................... 19
6ANI MONITOR V2 settings......................................................................................... 19
6.1 Language parameters............................................................................................. 19
6.2 Threshold.................................................................................................................. 20
6.3 Events ....................................................................................................................... 22
6.4 Expert mode and energy index............................................................................. 23
7Ending ANI monitoring............................................................................................... 26
7.1 Stopping the recording of a case.......................................................................... 26
7.2 Demo......................................................................................................................... 26
7.3 New patient............................................................................................................... 26
7.4 Maintenance............................................................................................................. 27
7.5 Deleting patient data............................................................................................... 27
7.6 Screen capture......................................................................................................... 27
7.7 Exporting data files.................................................................................................. 27
7.8 Updating events....................................................................................................... 31
7.9 Setting date and time.............................................................................................. 32
7.10 Updating monitor..................................................................................................... 33
7.11 Shutting down .......................................................................................................... 35
8Trouble shooting.......................................................................................................... 35
9Monitor disposal........................................................................................................... 36
10 Environment.................................................................................................................. 36

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10.1 Shipping and storage conditions........................................................................... 36
10.2Operating environment........................................................................................... 37
10.3 Power requirements and grounding..................................................................... 37
11 Cleaning and disinfection.......................................................................................... 37
11.1 Cleaning.................................................................................................................... 37
11.2 Maintenance............................................................................................................. 38
12 Specifications, warranty and software license contract................................... 39
12.1 Specifications........................................................................................................... 39
12.2 Accessories.............................................................................................................. 40
12.3 Warranty ................................................................................................................... 41
12.4 Software License Agreement................................................................................ 42

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1 Safety precautions
Caution: read this entire manual carefully before using the monitor in a clinical setting.
1.1 Warnings and safety instructions
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.
EXPLOSION HAZARD: DO NOT USE THE ANI MONITOR V2 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 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 ANI sensor to
minimize the effect of interference. Some ECT equipment may interfere with the ANI
monitor's 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.

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BE SURE THE MONITOR IS INSTALLED SECURELY TO AVOID INJURY TO
PERSONNEL OR PATIENTS.
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 V2 (MDOLORIS MEDICAL SYSTEMS) MAY
RESULT IN INCREASED ELECTROMAGNETIC EMISSIONS OR DECREASED
ELECTROMAGNETIC IMMUNITY OF THE ANI MONITOR V2 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 V2 MONITOR.
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-SENS-V1 ELECTRODES BETWEEN THE
SURGICAL SITE AND THE ELECTROSURGICAL UNIT'S RETURN ELECTRODE.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT CABLE MUST
BE CAREFULLY PLACED AND SECURED.

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DO NOT PLACE THE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADDLES
WHEN THEY ARE USE ON A PATIENT CONNECTED TO THE ANI MONITOR V2.
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 V2, 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 V2 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.

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IN OPERATING ROOMS, THE ANI MONITOR V2 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.
THE CHARACTERISTICS OF ANI MONITOR V2 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 V2 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 V2 MONITOR.
ANI MONITOR V2 THE SHOULD NOT BE USED ADJACENT TO OTHER DEVICES OR
STACKED WITH THEM ON PAIN OF CAUSINGMALFUNCTIONS. IN THE EVENT THAT
SUCH USE PROVES NECESSARY ANI MONITOR V2 SHOULD BE SUPERVIZED WITH
THE OTHER DEVICES IN ORDER TO CHECK THEY OPERATE IN THE NORMAL WAY.
STAFF SHOULD AVOID TOUCHING SIMULTANEOUSLY PATIENT AND ANI MONITOR
V2.
WHEN CHANGING THE POLE CLAMP, USE ONLY NYLON SCREWS TO ENSURE
INSULATION.

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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.
TO REMOVE POWER SUPPLY FROM THE MONITOR, UNPLUG THE POWER CABLE.
DO NOT AUTOCLAVE THE MONITOR. AUTOCLAVING WILL SERIOUSLY DAMAGE
BOTH COMPONENTS.
DO NOT BLOCK VENTILATION INLET HOLES OF MONITOR.
THIS MEDICAL EQUIPMENT, ITS COMPONENTS AND PACKAGING MUST BE
RECYCLED IN ACCORDANCE WITH LOCAL REGULATIONS ON THE ENVIRONMENT
AND DISPOSAL OF ELECTRIC WASTE.

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1.2 Key to symbols
Symbole
Description
Symbole
Description
Manufacturer +
Manufacturing Date
Fragile; handle with care
Serial number
Direct current, DC
Class II equipment
BF Type equipment, protects
against defibrillation
European compliance
Mark of compliance with
the European Medical
Device Directive
Caution: Federal law restricts
this device to sale by or on the
order of a (licensed healthcare
practitioner)
Consult operating manual
Needs special waste disposal
General safety sign
Upper and lower temperature
limits (Shipping and Storage
Environment)
Do not expose to
sunlight
Check the packaging quality
upon delivery
Keep dry
This way up