Related Manuals for Mdoloris ANI MOC-9
Summary of Contents for Mdoloris ANI MOC-9
- Page 1 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...
- Page 2 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.
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Page 3: Table Of Contents
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 .................... - Page 4 Service Instructions ......................25 Repair Policy ........................25 Warranty ........................... 26 4 | 30 MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020...
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Page 5: Product Description
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. -
Page 6: Warning And Caution Instructions
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. - Page 7 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.
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Page 8: 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. -
Page 9: Cleaning And Service Warnings And Cautions
• 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 9 | 30 MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020... - Page 10 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.
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Page 11: Chapter 1: Technology Overview
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. -
Page 12: Chapter 2: System Description
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 •... -
Page 13: Ani Moc-9
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. -
Page 14: Chapter 3: Setting Up Ani Moc-9 With Ani Sensors
Chapter 3: Setting Up ANI 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. -
Page 15: Connecting The Ani Moc-9 Module
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. 15 | 30... - Page 16 For more information on the ANI MOC-9 window, see The ANI MOC-9 Window section. 16 | 30 MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020...
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Page 17: Chapter 4: Operation
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. - Page 18 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.
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Page 19: Mode Of Operation
Réf Feature Description Slot 1 Displays the level and the value of the selected parameter Slot 2 Displays the value of the other parameters ANIm Averaged value of the ANI between 0 and 100 ANIi Instantaneous value of the ANI between 0 and 100 Energy Energy of the RR series Computation... - Page 20 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.
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Page 21: Chapter 5: Trouble Shooting
Too much noise on the Check that any other device can signal interfere. Power is not established Unplug the module then restart ANI MOC-9 module is not Root Monitor. recognized Module is not recognized 21 | 30 MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020... -
Page 22: Chapter 6: Specifications
Protect the ANI MOC-9 from sudden temperature changes that could lead to condensation within the instrument. To minimize condensation, avoid moving the system between heated buildings and outside storage. Once moved inside, allow the ANI MOC-9 to stabilize in the unopened shipping container at room temperature before unpacking and placing into service. -
Page 23: Regulatory Symbols
Regulatory Symbols The following symbols are on the product hardware or packaging Symbole Description Symbole Description Manufacturer Date of manufacture CE Marking of Conformity Serial number (93/42/EEC Directive) Defibrillation-proof type Refer to instruction manual CF applied part /booklet Caution: Federal law restricts this device to sale by or on the Fragile;... -
Page 24: Conformity
Conformity Safety conformity CEI 60601-1 :2005 + AMD1 :2011 EMC conformity CEI 60601-1-2, class A Safety Classification according to IEC 60601-1 Type of Protection Class II Degree of Protection against Electric Shock CF-type Degree of Protection against the Ingress of IP X1 according to Liquid IEC 60601-1... -
Page 25: Chapter 7: Service And Maintenance
Chapter 7: Service and Maintenance Cleaning and disinfection Cleaning of the ANI MOC-9 should be performed at regular intervals or in accordance with hospital, as well as local and governmental regulations. See Warning and caution instructions section. ANI MOC-9 is a reusable instrument which is supplied non-sterile. - Page 26 Mdoloris Medical Systems shall determine whether to repair or replace Products and parts covered by this warranty and all Products or parts replaced shall become Mdoloris Medical Systems’ property. In the course of warranty service, Mdoloris Medical Systems may but shall not be required to make engineering improvements to the Warranted Product or part thereof.
- Page 27 Mdoloris Medical Systems shall have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from normal wear and tear. Mdoloris Medical Systems makes no warranty (a) with respect to any products that are not Warranted...
- Page 28 Software License Agreement The computer software (“Licensed Software”) loaded on the ANI MOC-9 (“System”) is licensed, not sold, to you for use only under the terms of this license. Mdoloris Medical Systems reserves any rights not explicitly granted. You own the System, but Mdoloris Medical Systems retains all ownership rights and title to the Licensed Software itself.
- Page 29 Recycling electrical equipment helps preserve natural resources and prevents risk of pollution. In this respect, Mdoloris Medical Systems fulfils its obligations concerning the end- of-life of the ANI MOC-9 that it places on the market by financing the DEEE Pro recycling 29 | 30...
- Page 30 (For more information contact your Mdoloris agent) WARNING: to avoid any kind of contamination or infection to personnel, the environment or equipment, be sure you have properly disinfected and decontaminated the ANI MOC-9 before you dispose of your system.
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