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Mdoloris ANI MOC-9, Instructions For Use Manual, Page: 24 / 30

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Mdoloris ANI MOC-9 Instructions For Use Manual Download Page 24

MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020 

24 | 30

 

 

 

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 
Liquid  

IP X1 according to 
IEC 60601-1 

Mode of Operation  

Continuous 

 

Summary of Contents for ANI MOC-9

Page 1: ...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...

Page 2: ...OC 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 rea...

Page 3: ...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...

Page 4: ...MD PRD IN16 ANIMOC9 V 02 12 03 2020 4 30 Service Instructions 25 Repair Policy 25 Warranty 26...

Page 5: ...NI 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 analges...

Page 6: ...sonance 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 en...

Page 7: ...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...

Page 8: ...ers 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...

Page 9: ...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 AN...

Page 10: ...s 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...

Page 11: ...d on one time window of 64 sec This number shows the relative p activity as a part of ANS activity it expresses the relative amount of p tone present as compared to sum of sympathetic and p activities...

Page 12: ...ription 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 Energy...

Page 13: ...gned to work with specific disposable sensors It is inadvisable to use another kind of electrode The maximum consecutive period that the sensors can adhere to the skin is 24 hours The shelf life of th...

Page 14: ...king materials invoice and bill of lading These may be required to process a claim with the carrier 3 If anything is missing or damaged contact the Mdoloris Medical Systems Technical Service Departmen...

Page 15: ...locking mechanism and pull gently to disengage it Do not pull by grasping the sensors itself Locking mechanism Connecting the ANI MOC 9 module 1 Identify the Masimo Open Connect connector on the modul...

Page 16: ...MD PRD IN16 ANIMOC9 V 02 12 03 2020 16 30 For more information on the ANI MOC 9 window see The ANI MOC 9 Window section...

Page 17: ...e 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 The relative siz...

Page 18: ...composed by 2 slots 1 slot with trend line and value of a selected parameter and 2 slot with the values of the other parameters Only one trend can be displayed on the first slot You can choose this pa...

Page 19: ...patient with the sensor and to the root the calculation algorithm will automatically begin Note The ANI technology can be used with both conscious and unconscious patients whenever the physician wish...

Page 20: ...ery second that reflects the parasympathetic tone of the patient A calculation is made every second and then averaged over two time periods a short average average on 56 seconds and a longer average a...

Page 21: ...ted Check the patient cable is correctly connected to the sensor Cable and connectors are damaged Check that the cables and connectors are in good working order Sensors are misplaced Check that sensor...

Page 22: ...ndensation 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 unpacki...

Page 23: ...mity 93 42 EEC Directive Serial number Defibrillation proof type CF applied part Refer to instruction manual booklet Fragile handle with care Caution Federal law restricts this device to sale by or on...

Page 24: ...5 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 aga...

Page 25: ...Safety checks should be performed at regular intervals or in accordance with hospital as well as local and government regulations The following is a checklist for the general maintenance of the ANI M...

Page 26: ...s under this warranty shall be borne by the party shipping the Product Products shipped by Purchaser under this warranty shall be packaged in the original shipping container or equivalent packaging to...

Page 27: ...cal Systems makes no warranty a with respect to any products that are not Warranted Products b with respect to any products purchased from a person other than Mdoloris Medical Systems or its official...

Page 28: ...l Systems The Licensed Software contains trade secrets and to protect them you may not decompile reverse engineer disassemble or otherwise reduce the Licensed Software to a human perceivable form If y...

Page 29: ...reement will be construed under French laws If any provision of this License Agreement shall be held by a court of competent jurisdiction to be contrary to law that provision will be enforced to the m...

Page 30: ...arding electric and electronic items The ANI MOC 9 can be dismantled All of the electrical parts meet the RoHS2 standard If you have to dispose of old electrical equipment make sure it is recycled saf...

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