CSM Monitor MKII - Manual
Contents
1. BS Digital output Wireless range Display size Alarms Artefact rejection Sensor impedance range Battery Supply current Max battery lifetime Alkaline Max battery lifetime Rechargeable Charging time Weight Dimensions Classification Sensors Cable length Mounting options Memory Environment Operation Environment Transport and storage 400pV lt 2UVp p lt O 4pV RMS 1 250 Hz gt 140dB gt 50Mohm 2000 samples sec 14 bits equivalent 0 100 Filter 6 42 Hz 1 sec update 0 100 logarithmic Filter 75 85 Hz 1 sec update 0 100 Filter 2 42 Hz 1 sec update Wireless to RS232 link or USB ISM 2 4 GHz Up to 10 meters 32x17 mm High Low with user selectable limit Automatic 0 10kOhm measurement current 0 01 U QV Alkaline or rechargeable NiMH GAM6 IEC 6LR61 ANSI 1604A 25mA typical 30h stand alone 18h transmitting wireless See table in section 6 4 Hours CSMX04 only 130 g with battery 114x60x31 mm Internal power supply Class Il type BF continuous use Danmeter Neuro Sensors 195 cm 77 with 35 cm 14 split Velcro strip 42mm x 25mm Data recording 18 hours Temperature 10 40 C 50 104 F Rel humidity 30 75 Air pressure 700 1060 hPa Temperature 10 40 C 50 104F Rel humidity 30 95 Air pressure 700 1060 hPa If transport without sensors 20 70 C 4 158 F Cerebral State Monitor CSM DFU Page 21 9 ccessories CSMX042. CSI under certain circumstances When this happens attention must be paid to the stimuli received by the patient during surgery When the patient is asleep EMG activity can increase due to reflex reactions to painful stimuli during surgery lack of muscular relaxation or muscular rigidity caused by some opioids analgesics In the presence of hypnotically unrelated EMG administration of a neuromuscular blocking agent may cause the CSI to decrease Note Facial muscles will recover sooner than skeletal muscles When these artefacts are present the CSI should be interpreted with caution Communication POWER indicator on CSM Link does not turn on when power is connected Check power connection Replace power cable or try alternate outlet If POWER indicator is still not on send CSM Link for service LINK indicator on CSM Link Does not turn on Check that this actual CSM Link is chosen on the CSM If CSM cannot find the CSM Link Relocate CSM Link to obtain better signal quality Turn on RF communication in the CSM CSM and Link are connected but no data appears on recording terminal Check that the RS 232 or USB is connected Check that the recording terminal has the right setup Cerebral State Monitor CSM DFU Page 25 12 System and Error Messages For error codes 1 10 and 14 shown in the display contact the appropriate service or distribution centre See section 14 Together with the error code an audible alarm is activa
3. Event key 8 and the indicator Link flashes or choose skip in order not to establish a connection The radio is reactivated by pressing the Power On key 1 twice or the next time the CSM is switched on Accept the CSM Link by pressing the Set Event key 6 When link has been established the indicator Link will show a constant light Disconnecting CSM Monitor and CSM Link 1 2 3 Press Power On key twice within one second Highlight release using Event key 8 Press Set Event key 6 to disconnect CSM radio is inactive The radio is reactivated by pressing the Power On key 1 twice or the next time the CSM is switched on Connecting to CSM Link when the CSM radio is inactive 1 2 3 4 5 6 EN Note Turn on the CSM Link Power indicator shows a constant light Link indicator is off Press Power On key twice within one second The CSM monitor shows a list of CSM Links found Select CSM Link ID Serial No with the Event key 8 and the indicator Link flashes or choose skip in order not to establish a connection Accept the CSM Link by pressing the Set Event key 6 When link has been established the indicator Link will show a constant light If wireless has been active for more than five minutes without any connection to CSM Link the radio is deactivated Cerebral State Monitor CSM DFU Page 20 8 Specifications EEG sensitivity Noise CMRR Input impedance Sample rate CSI and update EMG
4. affected by absorption and reflection from structures objects and people Cerebral State Monitor CSM DFU Page 31 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Cerebral State Monitor CSM Is used exceeds the applicable RF compliance level above the Cerebral State Monitor CSM should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Cerebral State Monitor CSM Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the Cerebral State Monitor CSM The Cerebral State Monitor CSM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Cerebral State Monitor CSM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Cerebral State Monitor CSM as recommended below according
5. in serious injury to persons and instrument component damage e Disconnect from battery power when performing maintenance e Should an instrument be dropped or severely shaken it should immediately be taken out of service and inspected by qualified service personnel to ensure its proper function prior to use Cerebral State Monitor CSM DFU Page 26 e Operating the monitor close to equipment radiating high energy radio frequencies electrosurgical cauterizing equipment portable radios cellular telephones etc may cause Signal Disturbance If this happens reposition the monitor away from the source of interference See section 5 6 for additional information on artefacts e Donot allow fluids to spill or drip on the monitor A e Do not use the monitor when cardiac defibrillator is used e Patient cables are not protected against defibrillation Special Patient Populations The monitor will not render accurate readings when used on patients with severe neurological disorders and patients under 2 years of age The use of pacemakers might cause either long periods of artefacts or elevated CSI values Warranty DANMETER warrants that e The monitor is free from defects in material and workmanship under normal use and service for a period of 24 months from the date of delivery by Danmeter to the first purchaser e Accessories are free from defects in material and workmanship under normal use and service for a period of ninety 90 days
6. is below 3 the EEG is practically iso electric The prediction probability Pk between the CSI and the OAAS was 0 92 The OASS score correspond to OASS Clinical State Responds readily to name spoken in normal tone Lethargic response to name spoken in normal tone Responds only after name called loudly and or repeatedly Does not respond to mild prodding or shaking Does not respond to noxious stimulus PW AB o 1 Observers Assessment of Alertness and Sedation Cerebral State Monitor CSM DFU Page 15 5 4 EMG High levels of facial muscular or electromyographic EMG activity can interfere with the CSI under certain circumstances The monitor incorporates an EMG filter that removes most of the potential interfering EMG activity The EMG bar shows the energy of the EMG level in the 75 85 Hz frequency band 0 100 logarithmic The bar is located on the right side of the display EMG activity is expected to be present when the patient is awake When the patient is asleep EMG activity can increase due to e Reflex reactions to painful stimuli during surgery e Lack of muscular relaxation e Muscular rigidity caused by some opioids analgesics e Presence of large external electrical fields e g diathermy The EMG bar should be checked frequently especially in case of a sudden increase in the CSI If the increase in CSI is accompanied by an increase in muscular activity there is a risk that EMG is causing interfere
7. CSM rechargeable battery CSMXO5 CSM Power Charger CSMX06 Patient cable CSMX09 Carrying case CSMX10 Service manual English CSMX1 1 CSM Link Software CSMX12 CSM Link RS 232 CSMX19 CSM Link USB CSMX18 CSM Link PHILIPS VOI CSMX13 Velcro Strip 42mm x 25mm DMX004 RS 232 cable DMX013 USB cable DMX005 CSM Procedure Pack DMX007 Clip for patient cable CSMIUK User manual 10 Maintenance Routine Maintenance To ensure the monitor remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below There are no serviceable parts in this instrument and all service is to be carried out by the manufacturer Note If the monitor is dropped damaged or subjected to excessive moisture or high temperature it should immediately be taken out of service for examination by qualified service personnel Interval Routine Maintenance Procedure As required Clean the external surfaces of the monitor thoroughly before and after a prolonged period of storage Every 12 months 1 Inspect power adapter plug and cable for damage 2 Perform electrical safety checks including leakage current measurement Cerebral State Monitor CSM DFU Page 22 Cleaning Clean the monitor periodically by wiping the outer case with a lint free cloth lightly moistened with warm water and a mild non abrasive cleaning solution or 70 isopropyl alcohol Note The monitor case is resistant to the follow
8. Cerebral State Monitor Model CSM 2 User Manual Care Taf S t spray Monito ER danmeter i t Re Danmeter A S Kildemosevej 13 DK 5000 Odense C Denmark Tel 45 63 11 29 30 Fax 45 63 11 29 31 e mail info danmeter dk www danmeter dk 0543 Table of Contents 1 1 1 1 2 2 3 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 5 1 5 2 5 3 5 4 5 5 5 6 7 1 7 2 10 11 12 13 14 About this Man W A seta esti rena a ek a a a ee a OE YA E ea de 1 Indications tor US ea tat tan an a a E EE ene err mere ean 1 MISE OU A NO 2 Installation and Reparan parado odias 2 Skin Preparation and Sensor Positioning lia 3 Description Or the DEVIC isis 4 Gee ral OVERVIEW acc sorger rd a kd ee oe e 4 Keys and Controls Ve Ia da ists isisisi 5 Light Indicators ii 6 D scription OU KEYS ket de Cabarete a aa eldre a a base 6 Operation Display MOUNES inicia chet ay aste ve boy veso A iii 7 SEU Men litis a kap ik doo 9 SOM IS ina a hin cio a as 10 EMI o ii iia cas 11 CSM Parametros nia 12 Principleof Operation ennuis s srania a pat a pa at tt pa kek an n ka ofon fat dal 14 High Quality Amplifier ic TOT ty ka cent ee Po a e ek aa bn 14 Measurement PARE ka pite kwa len ave te ka kn ke si sa ea dio ana don ie kodenn 14 A settee eta ad a ete a E E 15 EMO 00 sen NN ake e kes a a SE a ta casas 16 Burst Suppression Indicator arrasa 16 Artefact and Noise Control ierann on A 16 CSM Battery Mains Operation bot fa
9. OFF ON OFF the link is completely inactive Set clock Config Sets clock Date Format Year Month Date Hours Minutes Seconds Back light Config Sets display light and light 0 Off brightness 1 Normal 1 2 Bright AutoLNK Contig Automatically establishes a Inactive Active SN wireless link to any CSM link within Inactive SN is approx 3 meters or to a specified only displayed if CSM link link is established The AutoLNK function When AutoLNK is set to Inactive e active CSM Link s within range will pop up in the Link display Select the CSM Link serial number you would like to connect to When AutoLNK is set to Active e active CSM Link within range will automatically be connected to CSM monitor When AutoLNK is set to SN e SM monitor automatically connects to the dedicated CSM Link if within range Cerebral State Monitor CSM DFU Page 10 Device Information Select submenu BS 0 47 CSI Device information 1 Info Link Log Info e Serial number e SW version e CSI version e AD version Link e indicates no CSM Link connected e f CSM Link connected the CSM Link serial number and software version will be shown Log e Serial number e 1 total no of CSM sessions e 2 totalno running hours 4 8 Events Pressing the Set Event key 6 results in a continuously numbered event with no description being displayed Pressing the Event Type key brings up the following selection menu BS 0 47 CSI Event
10. ak op e kak an n n eta pon ke ka pan open aa a a ie jak oka ee 17 Data Recording via CSM LAI si e REE a A es eee ek aou 19 CSM Link SONWA NE ON MONA ti at pan pol bs an ka nin a ot a rate 19 ESMERO pape 19 Speciation S 3 diz a ay a l ek RE ap er ab e kob a ak aye a skoba pa laaa en 21 AGCOSSOMIES inicie 22 A ka kas oo e ga e n ka ka ak a Ba pa pk ata rs pad de 22 TOUDE SEO OIG sik te e sa a ok kd sy ai E Hee A an a kak ao ase n a ede 24 System and Error MES SASS riada 26 Safety and WTA 26 Service and LANM SO Fi ah vi ta ik kai Pi kk is a a a a e e is a e a a n ob ki ken e ekite 28 This manual is published by Danmeter A S who reserves the right to improve and modify the contents without prior notice Modifications will however be published in future editions All rights reserved Cerebral State Monitor CSM amp CSI are trademarks of Danmeter A S Products manufactured by Danmeter A S Kildemosevej 13 DK 5000 Odense C Denmark English PN 561100006 04 Declaration of Conformity Danmeter A S hereby declares that the Cerebral State Monitor complies with the following standards EN IEC 60601 1 EN IEC 60601 1 2 EN IEC 60601 2 26 Following the provisions of 93 42 EE 1 About this Manual This manual is intended to assist the user in operating the Cerebral State Monitor CSM in a safe and effective manner This version of the manual was originally drafted approved and supplied by Danmeter A S in English Bef
11. arranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of Danmeter and Danmeter does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of Danmeter any other liability in connection with the sale of Danmeter products DANMETER DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION 14 Service and Contacts For service please contact Danmeter or the appropriate service or distribution centre to obtain a unique Service ID number for the CSM Before returning the device for service please carry out the following e Carefully describe what is wrong with the monitor e Clean the monitor before shipping it e Use only original packaging for return shipment e Include all accessories used when error occurred except used sensors Return the Monitor to Danmeter A S or appropriate service or distribution centre Note The Cerebral State Monitor CSM can only be returned with assigned Service ID number Head office Danmeter A S Kildemosevej 13 DK 5000 Odense C Denmark Tel 45 63 11 29 30 Fax 45 63 11 29 31 Email info danmeter dk www danmeter dk Cerebral State Monitor CSM DFU Page 28 Technical description Guidance and manufacturer s declaration electromagnetic emissions The Cerebral State Monitor CSM
12. dance too high If sensor impedance is gt 5kQ the CSI BS and EMG will be blanked displayed Check that sensors are not dry Check that the skin has been cleaned properly Clean skin as described in section 3 and attach new sensors Signal Quality Index SQI low If the impedance of the white or black sensors exceeds 1kQ the SQI will fall gradually Poor impedance conditions may cause the SQI to fall to 50 Artefacts can have many causes diathermy EMG etc are typical causes If SQI falls because of extensive use of diathermy it will rise as soon as the diathermy is stopped Check that all sensors and cable connections are correctly connected Has the use of any mechanical device that could generate high frequency activity e g patient warmer been initiated or is any such device in close proximity to the CSM sensors If possible move disturbing device away from the sensors Check grounding of disturbing device Reduce the influence from disturbing device by disconnecting CSM Power to let the CSM run from the battery Cerebral State Monitor CSM DFU Page 24 CSI is higher than expected Check anaesthetic delivery systems IV lines and status of vaporizers Some patients require a higher dose of drugs due to interpatient variability Adequate dosing for maintenance may not be sufficient for increased stimulation CSI rises along with EMG High levels of facial muscular or electromyographic EMG activity can elevate the
13. edure Pack is used Dry abrade the skin gently using the skin prep product or with a dry wash cloth or gauze to remove the non conductive skin layer See diagram below Caution Make sure no part of the sensors is in contact with any other conductive parts including earth ground If skin rash or other unusual symptoms develop remove sensors from patient Change sensors every 24 hours to check skin integrity Position the three sensors from your CSM Procedure Pack according to the diagram below Middle of forehead Left side of forehead Mastoid left side The diagram above shows a left sided setup right sided is also acceptable Place sensors at the side furthest from the surgical area The advanced signal processing the monitor ensures a a ONE in the positioning of the sensors up to 2 cm 0 78 in has no significant influence on the index However it is recommended to place the sensors on an area of the skull where only a few muscle fibres are present in order to achieve the best quality signal Note Once the sensors have been secured to the skin attach the colour coded wires on the patient cable to the appropriate sensor Cerebral State Monitor CSM DFU Page 3 4 Description of the Device 4 1 General Overview On Off CSM Patient cable power charge connection connection Battery lid Battery compartment Cerebral State Monitor CSM DFU Page 4 4 2 Keys and Controls Overview RED Erro
14. erated while the CSM battery is charged If power is disconnected the CSM will continue running on the CSM battery MR ar a Electrical Operation Only The CSM can be operated on mains with the CSM Power with or without any type of approved battery inserted Note When a CSM rechargeable battery CSMX04 is used it will charge automatically while the electrical power is connected ONLY a CSM Battery CSMX04 is to be charged in the CSM monitor Cerebral State Monitor CSM DFU Page 18 7 Data Recording via CSM Link 7 1 CSM Link Software Optional The real time data capturing software for the Cerebral State Monitor makes it possible to record online data wireless via the CSM Link The following data is recorded e Sl e BS e EMG e Sensor impedance e SA e EFG CSM automatically saves the last 18 hours of data and a maximum of 10 cases regardless of the state of the wireless link on or off 7 2 CSM Link Link status indicator Power indicator lt lt Connector for PC Terminal Connector power adapter Description of CSM Link Indicators Power Power Link Flashing Link selected Constant Link established Cerebral State Monitor CSM DFU Page 19 Connecting CSM Monitor and CSM Link See ee ki Turn on the CSM Link Power indicator shows a constant light Link indicator is off Turn on the CSM monitor The CSM monitor shows a list of CSM Links found Select CSM Link ID Serial No with the
15. ew alkaline batteries to ensure best results e Insert battery correctly Mains operation and CSM rechargeable batteries Warning Only for use with adapter CSMXO5 Ault Inc Model MW1 17 Note There is no alarm if the battery is not connected If no battery is inserted the monitor is switched off when the external CSM Power is removed There is no internal back up battery in the monitor Note The clock is powered by an internal battery with a limited life minimum 6 years from date of manufacture When the battery is used up the clock will be reset and the clock will blink on start up The monitor should then be sent for service Note To maintain and fully maximize the rechargeable battery lifetime always connect the monitor to the CSM Power when the device is not in use Battery Lifetime Fully charged CSMX04 only Wireless Link Backlight level Lifetime hours OFF OFF 10 5 Note OFF 1 9 0 IF 9V alkaline disposable batteries OFF 2 7 0 are used the battery lifetime ON OFF 10 0 indicated in the table can be 2 to ON 85 3 times longer ON 2 6 5 Cerebral State Monitor CSM DFU Page 17 CSM Power a Connect to power cable E Connect to CSM Power connection Insert the CSM rechargeable battery as indicated Connect mains cable to mains and turn on power Green indicator 3 lights up Turn on monitor When the CSM is connected to an electrical outlet and turned on the CSM can be op
16. from the date of delivery by Danmeter to the first purchaser If any product requires service during the applicable warranty period the purchaser should communicate directly with the local Danmeter service centre to determine the appropriate repair facility Repair or replacement will be carried out at Danmeter s expense subject to the terms of this warranty The product requiring service should be returned promptly properly packed and postage prepaid Loss or damage in return shipment to Danmeter shall be at purchaser s risk In no event shall Danmeter be liable for any incidental indirect or consequential damages in connection with the purchase or use of any Danmeter product This shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Danmeter shall not be responsible for any loss arising in connection with the purchase or use of any Danmeter product that has been e repaired by anyone other than an authorized Danmeter service representative e altered in any way so as in Danmeter s judgement to affect its stability or reliability e subject to misuse or negligence or accident or which has had the serial or lot number altered effaced or removed or e improperly maintained or used in any manner other than in accordance with the instructions furnished by Danmeter Cerebral State Monitor CSM DFU Page 27 This w
17. ing cleaning solutions e Renu klenz 16ml L Steris corp USA e Vesphene lise 8ml L Steris corp USA e Warm water e Isopropyl alcohol 99 e Acetone 10 e Hydrogen peroxide 3 Storage If the monitor is to be stored for a longer period it should first be cleaned and the battery removed Store in a clean dry atmosphere at room temperature and if available use the original packaging for protection Fuses Caution No user replaceable fuses in the monitor or CSM power Disposal The monitor should be disposed of taking into consideration environmental factors local laws and regulations All components can be safely disposed of in the approved manner as per hospital or locally regulated guidelines Remove battery if any before disposal Test Routines Refer to Service manual CSMX10 Cerebral State Monitor CSM DFU Page 23 11 Troubleshooting CSM does not turn on when power key is pressed Change to a new battery or a fully recharged battery If changing the battery does not help send the CSM for service Sensor alarm Red Error light turns on and CSI BS and EMG replaced by Check all sensors and their connections This alarm can also be caused by diathermy see section 5 6 Check the patient cable If not connected then connect it If faulty replace patient cable Check if either of the sensors are disconnected or badly connected Replace faulty sensor Blanked index but why Sensor impe
18. is intended for use in the electromagnetic environment specified below The customer or the user of the Cerebral State Monitor CSM should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emission Group 1 The Cerebral State Monitor CSM uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission Class B The Cerebral State Monitor CSM is CISPR 11 suitable for use in all establishments i including domestic establishments and Harmonic emission Not Applicable those directly connected to the public IEC EN 61000 3 2 low voltage power supply network that Voltage fluctuations Not Applicable supplies buildings used for domestic ae urposes flicker emissions PSR IEC EN 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The Cerebral State Monitor CSM is intended for use in the electromagnetic environment specified below The customer or the user of the Cerebral State Monitor CSM should assure that it is used in such an environment Immunity test IEC EN 60601 Compliance level Electromagnetic test level environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be discharge ESD 8 KV air 8 KV air wood concrete or IEC EN 61000 4 2 ceramic tile If floors are covered with syn
19. layed numerically as a percentage 0 100 100 equals best signal quality in Display Mode A If the impedance of the white or black sensors exceeds 1kQ the SQI will fall gradually Poor impedance conditions may cause the SQI to fall to 50 Sensor Impedance The impedance of the white and black sensors is continuously measured and displayed in Display Mode E Low sensor impedance values typically between 1 and 3 kQ are essential for good monitor operation A lt 1kQ readout means that sensor impedance is optimal Sensor Alarm The Sensor Alarm signals the interruption of reliable CSI calculation due to corrupted or interrupted EEG This is usually caused by the use of diathermia or a faulty sensor connection high sensor impedance or disconnection of sensor leads Should any of these situations occur the Red Error light 2 will turn on The CSI is not calculated during these periods but is replaced by Alarms High Low Alarms can be set to signal the moment when the CSI rises above and or falls below preset limits The High and Low Alarms can be turned on or off from the Alarm Menu where the High and Low Alarm limits can also be set The High Alarm is ONLY activated when the current CSI has been lower than the High Alarm value This is convenient when the High Alarm is set in the awake patient If High Alarm is set to 60 and High Alarm ON then the CSI must be lower than 60 once before the High Alarm is activated If the c
20. n How to select menu settings from Display Mode 1 Remove battery lid 2 From any Display Mode press any arrow on the Control key 9 3 The top menu appears 4 Note The last menu used is chosen How to set parameter values 1 Press the Control key Press the Control key Press the Control key 9 9a to select menu Press the Control key 9 to enter submenu to select parameter to highlight parameter value to select parameter value to store setting or 9c to cancel the selection and return 9 9 Press the Control key 9 Press the Control key 9 without any change 7 Press the Control key 9c to go back in one menu level steps Sx eo e ee a a b a b a b PAS gon If the Control key has not been activated in 20 sec the CSM returns to Operation Display Mode and stores the settings Note The change of settings will only be stored for future use after returning to Operation Display Modes Cerebral State Monitor CSM DFU Page 9 4 7 Settings Parameter Menu Description Values Default High Alarm Alarm Selects the CSI Alarm High Option ON OFF OFF Low Alarm Alarm Selects the CSI Alarm Low Option ON OFF OFF High Limit Alarm Selects the CSI High Alarm Level 2 99 60 Low Limit Alarm Selects the CSI Low Alarm Level 1 98 40 Language Contig Selects device language English Contrast Config Selects display contrast 15 35 20 RF interface Config Select radio link active If turned ON
21. nce When this happens attention must be paid to the stimuli received by the patient during surgery In the presence of hypnotically unrelated EMG administration of a neuromuscular blocking agent will cause the CSI to decrease Since patients receiving neuromuscular blocking agents cannot exhibit movement as a sign of arousal the CSI is a valuable tool in their anaesthetic management 5 5 Burst Suppression Indicator The monitor includes a Burst Suppression indicator to show periods when the EEG is iso electric or flat The indication appears in the upper left hand side of the graph window in the display and shows the percentage of burst suppression over the last 30 seconds of the EEG signal A BS 20 readouts means that the EEG has been iso electric during 20 of the last 30 seconds 5 6 Artefact and Noise Control The artefact rejection algorithm ensures that the incoming EEG is not contaminated with noise When excessive noise is detected the signal quality index is reduced reflecting the disturbance The artefact rejection algorithm will be active especially when diathermy and equipment creating external interference is used Cerebral State Monitor CSM DFU Page 16 6 CSM Battery Mains Operation The CSM can be operated in two different modes e Battery operated e Mains operated Warning Only standard alkaline batteries or CSM rechargeable battery CSMX04 must be used Battery operation alkaline batteries e Always use n
22. ore operating the monitor read this manual thoroughly with particular attention to all warnings and cautions Note Although the monitor is built and tested to exacting specifications it is not intended to replace the supervision of level of consciousness monitoring by medical personnel The user should become thoroughly familiar with the features operations and accessories of the monitor and exercise vigilance in its utilization WARNINGS are directions which if not followed could cause fatal or serious injury to an operator patient or any other person CAUTIONS are directions which if not followed could cause damage to the equipment described in this manual and or any other equipment or goods and or cause environmental pollution NOTES are intended to highlight unusual points as an aid to the operator 1 1 Indications for Use The monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital The monitor is a non invasive measurement tool to be used by a trained professional to measure the level of consciousness during general anaesthesia and sedation by use of variations in the frequency content of the spontaneous EEG It analyses the frequency shifts that take place in the EEG signal as the level of consciousness changes Based on this principle the monitor calculates the Cerebral State Index CSI which is used to e
23. r ight GREEN Power light 1 On Off 4 Display area a i ke Set Event y key 7 8 Display Event Type key key 9 Control key Cerebral State Monitor CSM DFU Page 5 4 3 Light Indicators 2 RED Error light Lights up when sensor error situations are detected 3 Lights when mains is connected 4 4 Description of Keys COLLECT 1 Power On Press once 1 Power Off Press and hold until Power Off bar disappears 1 Wireless Link connection disconnection or reconnection Press twice within 1 second 5 Mute key Mutes alarms 6 Set Event key Set link accessory 7 Display key Changes between graphical and information screen 7a For immediate impedance update 8 Event key Select event type Select link accessory 9 Control key Used for menu selection of parameter settings 9a Use the Control key to scroll in the menus or set values 9b Select a submenu or function 9c Go back one menu level Cerebral State Monitor CSM DFU Page 6 4 5 Operation Display Modes The CSM always starts up with display A Switch between displays A B C D and E by pressing the Display key 7 Mode D Mode C Mode B Mode A Mode E CSI trend histogram with 5 minute interval showing average lowest and highest CSI values within the interval EMG is displayed as a bar in the right panel CSI trend curve with event markers and BS curve EMG is displayed as a bar in the right panel Operation time and n
24. ratios called alpha and beta B Both of these show a shift in energy content from the higher to the lower frequencies during anaesthesia The relationship between these quantities is also analysed as a separate parameter B a E E Q ratio In i Pou In SENE 6 12Hz 11 21Hz The monitor also on line evaluates the amount of instantaneous burst suppression BS in each thirty second period of the EEG This measurement quantifies the amount of silent or flat EEG periods characteristic of the deepest levels of hypnosis These four parameters are used as input to a fuzzy logic classifier system that calculates the Cerebral State Index EEG 4 Pat FR CS Cerebral State Monitor CSM DFU Page 14 5 3 CSI Scale The CSI is a unit less scale from O to 100 where 0 indicates a flat EEG and 100 indicates EEG activity corresponding to the awake state The range of adequate anaesthesia is designed to be between 40 and 60 All values in the table are approximate values based on the mean values of the patient behaviour The relationship between the CSI the clinical state and the OASS score is shown in the table below CSI Clinical State 90 100 OAAS 5 80 90 Drowsy 4 60 80 Light anesthesia or sedation 3 i 2 1 1 yi ai 40 60 Range considered as adequate for surgical anesthesia Deep anesthesia in most cases 10 40 accompanied by burst suppression Close to coma BS burst suppression 0 10 larger than 75 When CSI
25. stimate the level of consciousness of the patient Cerebral State Monitor CSM DFU Page 1 1 2 List of Symbols Type BF equipment Stand by operation On Off Attention consult accompanying documents Do not dispose of in refuse collection Dispose of at a recycling station or equivalent in accordance with directive 2002 96 EC WEEE Ix gt 99 PP 2 Installation and Preparation The Cerebral State Monitor system consists of The Cerebral State Monitor User manual this document Rechargable 9V battery CSM Power Patient cable Carrying case Velcro strip 42mm x 25mm Clip for patient cable For further equipment please refer to the accessories list in chapter 9 Note The CSM monitor s EEG acquisition performance and its processing and calculating of the CSM parameters and waveforms are ONLY guaranteed by the manufacturer when using the CSM Procedure Pack part no DMX005 Using standard ECG electrodes is NOT RECOMMENDED Cerebral State Monitor CSM DFU Page 2 3 Skin Preparation and Sensor Positioning To ensure low sensor impedance cleanse skin using mild soap and water Note Alcohol is not recommended as a skin cleanser it leaves a film layer that may cause high sensor impedance If alcohol is used ensure 30 seconds drying time The CSM Procedure Pack contains a skin preparation product and 3 neuro sensors Note The performance of the CSM is only guaranteed by the manufacturer when the CSM Proc
26. tate Monitor CSM is intended for use in the electromagnetic environment specified below The customer or the user of the Cerebral State Monitor CSM should assure that it is used in such an environment Immunity test IEC EN 60601 Compliance level test level Cerebral State Monitor CSM DFU Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any parts of the Cerebral State Monitor CSM including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Page 30 Conducted RF IEC EN 61000 4 6 Radiated RF IEC EN 61000 4 3 3 Vrms 150kHz to 80 MHz 3 V m 80 MHz to 2 5 MHz Recommended separation distance d 1 2VP d 12 P 80 MHz to 800 MHz d 2 34 P 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is
27. ted Error codes 11 12 and 13 can occur if the patient cable or the electrodes are connected while the CSM is performing the start up check Take the following action 1 Turn off the CSM 2 Disconnect patient cable 3 Turn on the CSM 4 When the start up check has finished connect the patient cable for normal operation 13 Safety and Warranty Warnings e Not to be used in the presence of flammable gases explosion risk e When used with High Frequency HF surgery please note the positioning of the sensors see page 3 In order to reduce the hazard of burns the sensors should not be located between the surgical site and the electro surgical unit return sensor e Pay attention if the monitor is connected to a patient connected to other equipment The total of leakage current may exceed the allowable limit and cause a possible hazard to the patient e The conductive parts of sensors and their connectors including the neutral sensor should not contact other conductive parts including earth Cautions e The monitor should be used in conjunction with other patient monitoring parameters and clinical signs This will ensure the optimum balance of the anaesthesia sedation administration e Do not open the instrument case There are no user serviceable parts inside The case should only be opened by qualified service personnel using proper grounding techniques When the case is opened an electrical shock hazard exists which can result
28. thetic material the relative humidity should be at least 30 Electrical fast 2 kV for power Not Applicable Mains power quality transient burst supply lines should be that of a IEC EN 61000 4 4 1 kV for typical commercial or input output lines hospital environment Surge 1 kV differential Not Applicable Mains power quality IEC EN 61000 4 5 mode should be that of a Cerebral State Monitor CSM DFU Page 29 Voltage dips short interruptions and voltage variations on power supply lines IEC EN 61000 4 11 2 kV common mode lt 5 li gt 95 dip in 4 for 0 5 cycles Not Applicable 40 Li 60 dip in 4 for 5 cycles 70 Li 30 dip in 4 for 25 cycles lt 5 Wi gt 95 dip in W for 5 sec typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the CSM requires continued operation during power mains interruptions it is recommended that the CSM be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic filed IEC EN 61000 4 8 3 A m Not Applicable NOTE dis the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment The Cerebral S
29. to the maximum output power of the communications Rated maximum Separation distance according to frequency of transmitter output power m ocu 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 23JP For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Cerebral State Monitor CSM DFU Page 32
30. types 1 Induction Intubation Maintenance The following event description options can be selected Induction Intubation Maintenance Surgery Injection Note End Maintenance and Movement When the desired option has been selected press the Set Event key 6 to confirm If no selection is made within 5 seconds the system returns to the current Display Mode Only the event numbers are visible on Display Mode C Event names will only be displayed when using the CSM Link option Events can be set with intervals of 3 seconds Cerebral State Monitor CSM DFU Page 11 4 9 CSM Parameters BS Indicator The amount of Burst Suppression very low amplitude or flat EEG is displayed in all Display Modes at the top left hand side Please refer to Section 5 5 for further information on the BS measurement EMG and EMG bar The EMG level is displayed either as a numerical percentage 0 100 value in Display Mode A or graphically as a bar at the right hand side in Display Mode C and D Please refer to Section 5 4 for further information on the EMG measurement Signal Quality Indicator SQI SQI measures the quality of the acquired EEG signal The calculation is based on a number of artefacts during the last minute The electrode to skin impedance is included in the SQI calculation Higher electrode to skin impedances reduce the SQI Only electrode to skin impedances at 1 kQ and 1 kQ will result in a SQI of 100 This quantity is disp
31. umeric value of the actual CSI and BS The time scale for the trend curve is 5 27 minutes and each tag is 60 seconds Displays 3 seconds of EEG waveform Use Event key 8 to scale up and down EEG scales are 200uV 100uV default 50uV 20uV and 10pV BS 0 47l EMG 11 csi SQI 100 10 12 05 BAT E 0 47 11 Main information window with CSI BS EMG SQI clock operation time and battery operation BS 0 LNK a csi Black lt 1kQ 10 12 05 White lt 1kQ 0 47 11 Sensor impedance CSI BS clock and operation time When display E is active the sensor impedance is updated every 60 seconds Press Display key 7a firmly for immediate impedance update Cerebral State Monitor CSM DFU Page 7 The EEG waveform is derived from the signal recorded between the frontal and mastoid electrodes The frequency content is 2 35 Hz If the EEG amplitude is low then in some conditions the ECG might be detectable in the EEG waveform Operating time and numerical value for current CSI and BS The time scale for the histogram graph is 180 min The interval between each tag is 60 min The high low bar in the current time interval high low bar to the far right is updated dynamically Special display features Artefact Sensor alarm Cerebral State Monitor CSM DFU Page 8 4 6 Setup Menu General menu structure and menu selections Top Menu BS 0 47 CSI Menu 1 Alarm Config Device informatio
32. urrent CSI goes higher than 60 the CSM monitor alarm sounds The same functionality is present for the Low Alarm Cerebral State Monitor CSM DFU Page 12 Battery Symbol An icon labelled BAT in Display Mode A indicates the remaining battery capacity For further information on battery operation of the CSM please see section 6 Mi Battery about 50 percent charged IL Battery charging when icon animates a Battery fully charged if not animated Note ONLY a CSM Battery CSMX04 is to be charged in the CSM Monitor LINK Signal Symbol An icon labelled LNK in Display Mode E indicates the state of the data transfer connection via the CSM Link For further information on the CSM Link feature please see section 7 Acoustic signals Start up 3 beeps Event 1 beep Alarm High Low 2 beeps per sec Mute mute 60 sec Low Battery 2 beeps per sec Mute mute 60 sec Cerebral State Monitor CSM DFU Page 13 5 Principle of Operation 5 1 High Quality Amplifier An instrumentation amplifier collects ongoing EEG with a high Common Mode Rejection Ratio ensuring a high quality EEG acquisition Special artifact detection algorithms are used to eliminate their effects on subsequent CSI calculations 5 2 Measurement Principle The performance of the CSI is based on the analysis of the frequency content of the EEG signal The energy of the EEG is evaluated in specific frequency bands These are used to define two energy
Download Pdf Manuals
Related Search