Mdoloris PTA Monitor User manual

MD/PRD/IN16.PTA v.06 - 12 MAR 2020
User manual
PTATM monitor
Software version: V2.3.0.0
Société Mdoloris Medical Systems SAS
270, rue Salvador Allende
Biocentre Fleming, Bâtiment C
Parc Eurasanté - Epi-de-Soil
59120 LOOS
Tél : [phone] - Fax : [phone]
www.mdoloris.com
Continuous analgesia monitoring system

PTA monitor User manual
MD/PRD/IN16.PTA v.06 - 12 MAR 2020
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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 a commercial registered trademark.
Important information about the use of PTA monitor:
The Mdoloris Medical Systems’ PTA monitor 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 PTA monitor is intended to be used on animals (dogs,
cats, horses) in a veterinary clinic or in research center, in order to
monitor the parasympathetic tone thanks to the ECG signal
acquisition.
The PTA monitor can be used to monitor the effects of certain
analgesic agents.
PTA is a complex monitoring technology intended to be used as an
adjunct to clinical judgment and to clinical experience. The
interpretation of the PTA value must always be submitted to the
clinical judgment and with other available clinical signs observed. It
is advisable to not rely only on the PTA index for monitoring the
patient’s analgesia level. As with all monitored parameters, artifacts
and poor signal quality may lead to inappropriate PTA values. The
potential artifacts can be caused by high impedance from the
source ECG collection device, by muscle activity or rigidity, patient
motion, improper sensor placement or electrical interference.
PTA is a protected trademark.

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Table of contents
1Safety precautions............................................................................................................4
1.1 Warnings..................................................................................................................4
1.2 Caution.....................................................................................................................8
1.3 Notes........................................................................................................................8
1.4 Key to symbols.........................................................................................................9
2PTA monitor introduction.............................................................................................10
2.1 PTA index..............................................................................................................11
2.2 Position of sensors and ECG acquisition.................................................................11
2.3 Monitor setting.......................................................................................................12
2.4 Demo mode............................................................................................................12
3Start the PTA monitoring..............................................................................................13
4Use and settings..............................................................................................................15
4.1 Languages..............................................................................................................15
4.2 Thresholds..............................................................................................................15
4.3 Events ....................................................................................................................18
4.4 Expert mode and Energy index...............................................................................18
4.5 Snapshot.................................................................................................................20
5End of the PTA monitoring...........................................................................................21
5.1 Quit the current recording.......................................................................................21
5.2 New patient............................................................................................................21
5.3 Maintenance...........................................................................................................21
5.4 Export the data recorded.........................................................................................22
5.5 Deletion of patient’s data........................................................................................22
5.6 Events update.........................................................................................................22
5.7 Date and time settings ............................................................................................23
5.8 Update monitor.......................................................................................................24
5.9 Shut down..............................................................................................................24
6 Troubleshooting.............................................................................................................25
7Monitor disposal ............................................................................................................25
8Environnement...............................................................................................................26
8.1 Shipping and Storage Environnement.....................................................................26
8.2 Operating Environnement.......................................................................................27
8.3 Power Requirements and System Grounding..........................................................27
9Cleaning and disinfection ..............................................................................................27
9.1 Cleaning.................................................................................................................27
9.2 Leakage Current.....................................................................................................28
10Specifications, warranty and software license agreement............................................29
10.1 Specifications.........................................................................................................29
10.2 Warranty ................................................................................................................30
10.3 Software Licence Agreement..................................................................................32

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1Safety precautions
INTRODUCTION
Caution: carefully read this entire manual before using the monitor in a clinical
environment.
WARNING
A warning of this level of danger advises against potentially dangerous situation that could
results in physical injury or death. Accidents may be caused by the inability to avoid
dangerous situation. That is why it is important to follow guidelines in this warning, to avoid
physical injuries.
, CAUTION
A caution of this level of danger advises actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is unlikely.
NOTE
A note provides useful information regarding a function or procedure.
DEFINITION OF SYMBOLS
Symbols used with the PTA monitor are explained at the end of this section (section 1.4, page
09).
1.1 Warnings
IT IS FORBIDDEN TO KEEP CONNECTED THE PTA MONITOR ON ANIMAL
WHEN A DEFIBRILLATOR DEVICE IS USED.
LEAKAGE CURRENT MUST BE CHECKED BY A TECHNICIAN QUALIFIED IN
BIOMEDICAL ENGINEERING WHENEVER INSTRUMENT CASE IS OPENED.

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EXPLOSION HAZARD: DO NOT USE THE PTA MONITOR IN A FLAMMABLE
ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE
ANESTHETICS MAY OCCUR.
THIS MONITOR IS NOT DESIGNED FOR USE IN THE MRI ENVIRONMENT.
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 THE EXTERNAL PROTECTIVE EARTH GROUND IS IN
DOUBT, THE PTA MONITOR SHOULD NOT BE USED.
BE SURE THE MONITOR IS INSTALLED SECURELY TO AVOID ANY INJURY
FOR THE STAFF OR FOR THE PATIENT.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS
SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING GROUND
LOOP.

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ON ELECTRICAL SHOCK HAZARD :
-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 OF THIS DEVICE HAS VERIFIED THAT THE
GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY CURRENT
WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY THE
APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE PRACTICE,
THE INSTITUTION SHOULD ALSO CONDUCT TESTS TO VERIFY THESE
CURRENTS ESPECIALLY WHEN A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN PERIODICALLY OPENS THE
INSTRUMENT CASE.
-WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS
OCCURS, RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER
USE.
IN CASE OF EMERGENCY FOR INTERRUPTING THE ELECTRICAL POWER, IT
IS NECESSARY TO USE THE MALE END OF THE POWER CORD OR THE WALL
SOCKET. THE ACCESS OF THE POWER PLUG AND THE WALL SOCKET HAVE
TO STAY REACHABLE DURING THE NORMAL USE.
CURRENT PRECAUTIONS SHALL BE OBSERVED TO PREVENT ANY CONTACT
WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS.
CONTAMINATED MATERIALS MUST BE DEALT IN ACCORDANCE WITH ALL
APPLICABLE HYGIENE STANDARDS AND REGULATIONS.

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DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA).
HAZARDOUS GASES MAY RESULT.
THE PTA MONITOR COMPLIES WITH ELECTROMAGNETIC COMPATIBILITY
REQUIREMENTS OF EN 60601-1-2. THE OPERATION OF THIS DEVICE MAY
AFFECT OR BE AFFECTED BY OTHER EQUIPMENTS IN THE VICINITY DUE
TO ELECTROMAGNETIC INTERFERENCE (EMI). IF THIS OCCURS:
- INCREASE THE SEPARATION BETWEEN DEVICES
-CHANGE THE ORIENTATION OF DEVICE CABLING
-PLUG DEVICES INTO SEPARATE CIRCUIT OUTLET
IN CASE OF PERSISTENT DYSFUNCTION, PLEASE CONTACT YOUR
MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE.
THE PTA MONITOR IN OPERATING SURGICAL ROOM MUST BE PLACED
OUTSIDE THE SAFETY CONE OF EXPLOSION RISK.
BE SURE THAT THE MONITOR IS PLACED OUT OF AN AREA PRESENTING A
RISK OF PROJECTION OF LIQUID (E.G.: UNDER AN I.V. BAG).
ANY MODIFICATION IN THE MONITOR IS STRICTLY FORBIDDEN.
THE USB PLUG MUST NOT BE CONNECTED TO ANY OTHER EQUIPMENT
THAN A USB STICK.

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1.2 Caution
The equipment should not be reachable by the patient, directly or indirectly, like placed on a
metallic material reachable by the patient.
The patient and the equipment should not be touched simultaneously by the doctor.
Do not put the monitor in an autoclave. Putting the monitor in an autoclave will seriously
damage the PTA monitor.
It is forbidden to use accessories other than those specified (e.g.: ECG cable, power cord)
because it may result in increased electromagnetic emissions or decreased electromagnetic
immunity of the monitor.
The PTA Monitor should not be used adjacent or stacked on other equipment. If adjacent or
stacked use is necessary, check regularly that the functioning is normal in this configuration.
Only staff of Mdoloris Medical Systems is allowed to perform maintenance operations or
repairs. Only the following elements can be replaced or substituted by an untrained staff to
the technical maintenance (respecting the manufacturer references):
-ECG cable and associated accessories (e.g.: crocodile clips) ;
-The power cord ;
-The power supply box.
The recycling of this medical equipment, its components and packaging must be done in
accordance with the national laws of the country on electronic wastes and environment.
1.3 Notes
The “NOTES”can be found at the end of each related chapter.

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1.4 Key to symbols
Symbol
Description
Symbol
Description
Consult the operating
manual
Manufacturer’s serial number
Do not expose to liquids
European conformity. Mark of
conformity to European medical
device directive
Do not expose to sunlight
General hazard symbol
Do not use if the
packaging is damaged
This symbol indicates that
electric and electronic wastes
must not be disposed as
unsorted household waste and
must be collected separately.
The device has a
functional electrical
insulation with a ground
terminal and an
equipotential connection
Direct current
Reference
Temperature range
Manufacturer (company’s
name and date of
production)
Symbol of package handling
(Fragile, to handle with caution)
Symbol of package
handling (keep in dry
conditions)
Symbol of package handling
(handle with caution)
to handle with caution
(keep in upright position)
BF equipment

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2PTA monitor introduction
PTA (Parasympathetic Tone Activity) is a normalized and continuous measure of the
parasympathetic tone (p) which is a part of the autonomous system (ANS). It uses the
punctual and quick increase of pƩ tone induced by each respiratory cycle (spontaneous or
artificial) to measure the “relative quantity” of pƩ tone.
These rapid changes in pƩ tone express in the sinus node of the heart by changes in the time
intervals between two R waves of the electrocardiogram. The normal next RR series
(stemming from a cardiac cycle and not from an extrasystole) establish the RR series. After
filtering, normalization and resampling, the pƩcompound of the RR series is obtained by
measuring the generated surface by the respiratory cycles (figure 15). More important is the
pƩ tone, bigger is the measured area.
PTA measurement cannot be interpreted in the following situations:
•arrhythmia
•lack of breathing (e.g.: apnea due to the intubation)
•respiratory rate lower than 8 cycles/min
•variable tidal volume during the period of measurement for calculations, that is to say
64 seconds
•irregular breathing (when the patient sneezes/coughs, or produces a noise [e.g.: a
growl])
•Use of medicine having an impact on the sinus node activity (atropine or others
catecholamines)
The PTA index is expressed on a scale between 0 and 100. It reflects the activity of the
parasympathetic nervous system. It gives a reading of the proportion of pƩ tone compared to
the Ʃ tonus in the autonomous nervous system. The PTA displayed represents the successions
of computed measures: each elementary measure is carried out on 64 seconds, with a 1 second
moving window.