Narcotrend Compact M, Operating Instructions Manual

Page 1: ...ion 3 2 MT MonitorTechnik GmbH Co KG Maienbass 27 24576 Bad Bramstedt Germany Copyright MT MonitorTechnik GmbH Co KG All rights reserved This document must not be reproduced edited or copied without t...

Page 2: ...nd the general recorded data quality which could affect the report data accuracy must also be taken into account It is the physician s responsibility to make the diagnosis or to obtain expert opinion...

Page 3: ...7 5 1 Title line 17 5 2 EEG 17 5 3 Stage Index 18 5 4 Additional parameters 19 5 4 1 EMG 19 5 4 2 BSR 19 5 4 3 STI 19 5 5 Diagrams 19 5 5 1 Cerebrogram 20 5 5 2 Relative Band Activities Power 20 5 5 3...

Page 4: ...checks 37 8 3 Error messages 38 8 4 Battery 40 8 4 1 Checking the battery 40 8 4 2 Changing the battery 40 8 5 Disposal 40 9 Technical data 41 9 1 Symbols 41 9 2 Classification and technical data 42...

Page 5: ...G on a scale ranging from stage A conscious to stage F very deep hypnosis This division of stages is refined by means of an EEG index 100 conscious 0 very deep hypnosis Fig 1 EEG index EEG stages und...

Page 6: ...otrend Compact M Narcotrend Compact M power supply Patient lead 1 channel PKM1 Patient lead 2 channel PKM4 optional Mounting clamp optional Use only the original Narcotrend Compact M power supply Fig...

Page 7: ...peration To switch off the device use the button QUIT on the screen 2 2 Battery operation The Narcotrend Compact M is equipped with an integrated battery that allows the device to be used for at least...

Page 8: ...lay the values on a Bluetooth enabled external device The reception of data from the external device is not provided The point to point connection enables just one device to connect with the Narcotren...

Page 9: ...2 RxD Narcotrend Compact M 5 RS232 Ground For further information see the document NAT_InterfaceSpecification_2017 09 26 Integrating the Narcotrend Compact M into a network can lead to previously unid...

Page 10: ...equirements and or harmonized national standards The use of a defibrillator is restricted The electrodes must not be placed between the defibrillator pads Before putting the device into operation chec...

Page 11: ...safety instructions included with the high frequency surgical device It is forbidden to continue to operate the system if the neutral electrode is defective During the use of diathermy high frequency...

Page 12: ...safety and proper condition of the device A damaged device must not be put into operation Do not block the ventilation inlet holes on the equipment s rear panel The touchscreen reacts very sensitively...

Page 13: ...l Electrodes made of different materials must not be used together Avoid placing the electrodes over bone gaps scars or skin lesions Whenever electrodes are placed on oedematous skin areas it is impor...

Page 14: ...thoroughly 3 Rub the skin dry with a dry gauze swab 4 Pull off the protective material from the electrode and then stick the electrode on the skin Avoid exerting pressure on the center of the electrod...

Page 15: ...of birth and the name of the last record in the corresponding input lines To start a recording the following requirements must be fulfilled patient lead is connected a valid date of birth has been en...

Page 16: ...Check Date Time To change the time or date change the corresponding values and confirm with the APPLY button Language The language used for the device can be set by selecting the corresponding button...

Page 17: ...birth and age in years months Date and time Bluetooth RS232 symbol when function is switched on Power supply symbol or battery symbol In the title bar also system messages such as information about t...

Page 18: ...classification In the ICU version not provided The current assessment always refers to Channel 1 If the raw EEG is not classified additional information e g recognized artifacts or atypical signal pat...

Page 19: ...suppression ratio quantifies the suppression percentage of a 60 s EEG epoch It is displayed on a scale from 0 no suppression detected to 100 isoelectric EEG 5 4 3 STI STI sharp transient intensity The...

Page 20: ...he stages A F with the corresponding sub stages and the right axis shows the index range 0 to 100 In an ongoing recording a white triangle at the upper margin of the cerebrogram indicates the current...

Page 21: ...and 0 5 3 5 Hz theta band 3 5 7 5 Hz alpha band 7 5 12 5 Hz beta band 12 5 Hz In the very deep stages E2 F0 and F1 the power spectrum is shown in gray Fig 11 Power Spectrum 1 channel and 2 channel 5 5...

Page 22: ...layed The scale of the cerebrogram is designed accordingly If there is an EEG without suppression lines the output is Undiff EEG This stands for undifferentiated EEG EEG classification among children...

Page 23: ...de check and shows the impedance values of each electrode The button text is changed to EEG Pressing the button again stops the manual electrode test and displays the EEG again Shows the menu for sett...

Page 24: ...Fig 13 Recording screen during the review mode In the review mode the current EEG and classification is not shown This is indicated by the red flashing message Review A vertical line in the diagrams...

Page 25: ...time independent of the automatic electrode checks Adherence to the limit values for the impedances is required in order to ensure proper operation of the device Furthermore it is important to make s...

Page 26: ...equirements OPTIONS button on the start screen Shows the list of predefined markers 1 10 Shows the list of predefined markers 11 20 Sets markers with self defined text Shows the list of all set marker...

Page 27: ...alogue is used to adjust several program options The preferences for the automatic electrode check and the diagram scales can be changed Fig 15 Menu Options The settings in this dialogue are valid onl...

Page 28: ...end Index NI Result of the automatic classification Only for IntelliBridge On the Philips IntelliVue patient monitor only the Narcotrend Index can be represented the stage is not visible The following...

Page 29: ...ssion ratio is the percentage of suppression lines in the EEG The value refers to the last 60 s and is issued as a value between 0 no suppression lines and 100 continuous suppression line STI STI STI...

Page 30: ...hreshold values 8 k 5 k 6 5 Error messages The following error messages are outputted INOP Description NARCOTR LEAD OFF Patient lead is not connected NARCOTR CHECK IMP One or more impedance values hav...

Page 31: ...recordings or screenshots that have been stored A recording or screenshot is selected by direct touch or via the buttons on the right hand side next to the list Only for recordings At the bottom of t...

Page 32: ...ecording screenshot and moves the selection bar down Marks all recordings screenshots Moves the selection bar down Displays the selected recording screenshot review Copies the selected recordings scre...

Page 33: ...ngs If recordings which are longer than 24 hours shall be displayed at first the recording period day has to be selected This day will then be shown completely Apart from the button bar the screen is...

Page 34: ...e displayed EEG and the related parameters It is possible to select any point on the time axis by tapping on the touchscreen or to navigate through the recording via the buttons Date and time in the t...

Page 35: ...torage medium will be accepted by the device Depending on the memory capacity the detection of a USB storage medium may take some minutes The USB port provides 500mA at 5V 7 3 Print For the selected o...

Page 36: ...hypochlorite or wipe the surfaces with disinfectant containing alcohol e g Meliseptol or disinfectant with the active ingredient chlorine dioxide e g Tristel Jet After cleaning disinfection dry all a...

Page 37: ...on of the plug in connections on the Narcotrend Compact M firmly seated in the housing pins not bent Condition of the patient lead sheath plug in connections undamaged Proper labeling type plates fitt...

Page 38: ...whose impedance levels are not displayed as green Connect 1 channel patient lead Without the additional option 2 channel 2 channel measurement cannot be started Connect a 1 channel patient lead and t...

Page 39: ...atient s head and the connections to the patient cable Press the pad gently or glue on a new electrode 50 Hz or 60 Hz AC artifacts occur In case of excessive artifact load the signal is not evaluated...

Page 40: ...parts and part numbers The following steps are to be carried out 1 Unplug the power supply from the Narcotrend Compact M 2 Open the battery box by loosening the 2 screws at the back side 3 Remove the...

Page 41: ...water vertically falling drops Expiration date Federal law U S A restricts this device to sale by or on the order of a physician For single use only MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL...

Page 42: ...ss A not life supporting IP Code IPX1 MEDCERT Zertifizierungs und Pr fungsgesellschaft f r die Medizin GmbH Kennnummer 0482 Operating conditions Operating mode Continuous operation Environmental tempe...

Page 43: ...ead PKM1 1 channel 3 electrodes EK 0306 Patient lead PKM4 2 channel 4 electrodes EE 0203 25 Narcotrend Electrode EE 0203 1 pouch 25 pcs EE 0203 250 Narcotrend Electrode EE 0203 10 pouches 25 pcs NC 01...

Page 44: ...mmunications equipment and the Narcotrend Compact M The Narcotrend Compact M is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the...

Page 45: ...ifferential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltag...

Page 46: ...ransmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference could occur in the vicinity of equipment marked with the follo...

Page 47: ...posable electrodes 2 channel PKM4 14 Fig 6 Start screen 15 Fig 7 Recording screen 17 Fig 8 Cerebrogram 20 Fig 9 Relative Band Activities Power 1 channel and 2 channel 20 Fig 10 Quantiles 1 channel and...