CSM Monitor MKII - Manual
Contents
1. Cerebral State Monitor CSM DFU Page 9 47 Settings Parameter High Alarm Low Alarm High Limit Low Limit Language Contrast RF interface Set clock Back light AutoLNK The AutoLNK function When AutoLNK is set to Inactive Menu Alarm Alarm Alarm Alarm p Config p Config p y Con Config Config Descript Selects 1 Selects 1 Selects 1 Selects 1 Selects t Selects t Select r OFF the Sets cloi Month I Seconds Sets dis brightne Automat wireless approx CSM link n e CSI Alarm High Option e CSI Alarm Low Option e CSI High Alarm Level e CSI Low Alarm Level vice language splay contrast lio link active If turned nk is completely inactive Date Format Year ate Hours Minutes ay light and light S ally establishes a nk to any CSM link within 0 feet or to a specified Values Default ON OFF OFF ON OFF OFF 2 99 60 1 98 40 English 15 35 20 ON OFF ON 0 Off 1 Normal 1 2 Bright Inactive Active SN Inactive SN is only displayed if link is established 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 active CSM Link within range will automatically be connected to CSM monitor When AutoLNK is set to SN CSM monitor automatically connects to the dedicated CSM Link if w2. 7 Display Mode D Display Mode C Display Mode B Display Mode A Display 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 BS 0 CSI trend curve with event markers and BS curve EMG is displayed as a bar in the right panel Operation time and numeric value of the actual CSI and BS The time scale for the trend curve is 5 27 minutes and each tag is 60 seconds BS 0 Displays 3 seconds of EEG waveform Use Event key 8 to scale up and down EEG scales are 200uV 100yV default 50uV 20uV and 10pV BS 0 47 EMG 11 cs 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 44 LNK p cs Black 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 derives 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 EMG is shown in the display as a bar in the right hand side Operating time and numerical value for current CSI
3. Cerebral State Monitor makes it possible to record online data wireless via the CSM Link The following data is recorded e CSI e BS e EMG e Sensor impedance e SQI e EEG CSM automatically saves the last 18 hours of data and a maximum of 10 cases independent of the state of the wireless link on or off 72 CSM Link Link status indicator Power indicator Connector power adapter Description of CSM Link Indicators Power P wer Link Flashing Link Selected C astant Link established Cerebral State Monitor CSM DFU Page 19 Connecting CSM Monitor and CSM Link DSE Feo Na 8 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 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
4. 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 Artifact Sensor alarm CSI BS EMG SQI SQI value Cerebral State Monitor CSM DFU Page 8 4 6 Setup Menu General menu structure and menu selections Top Menu BS 0 47 CSI Menu Config Device information 1 How to select menu settings from Display Mode 1 2 3 4 Remove battery lid From any Display Mode press any arrow on the Control key 9 The top menu appears Note The last menu used is chosen How to set parameter values 1 OY avc om 7 Press the Control key 9a to select menu Press the Control key 9b to enter submenu Press the Control key 9a to select parameter Press the Control key 9b to highlight parameter value Press the Control key 9a to select parameter value Press the Control key 9b to accept setting or 9c to cancel the selection and return without any change Press the Control key 9c to go back in one menu level steps 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
5. 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 IEC EN 61000 4 5 1 kV differential mode Not Applicable Mains power quality should be that of a Cerebral State Monitor CSM DFU Page 30 Voltage dips short interruptions and voltage variations on power supply lines IEC EN 61000 4 11 X2 kV common mode lt 5 U gt 95 dip in 4 for 0 5 cydes 40 Ut 60 dip in 4 for 5 cycles 70 Ut 30 dip in Uf for 25 cycles lt 5 Ut 795 96 dip in 4 for 5 sec Not Applicable typical commercial or hospital environment 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 field IEC EN 61000 4 8 3 A m Not Applicable Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE amp is the a c power voltage prior to application of the test level Guidance and manufacturer s declaration electromagneti
6. 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 As required Every 12 months Routine Maintenance Procedure Clean the external surfaces of the monitor thoroughly before and after a prolonged period of storage 1 Inspect power adapter plug and cable r damage 2 Perform electrical safety checks includ g 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 following cleaning solutions Renu klenz 16ml L Steris corp USA Vesphene lise 8ml L Steris corp USA Warm water Isopropyl alcohol 99 Acetone 10 Hydrogen peroxide 3 Same solutions can be used for cleaning the patient cable 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 law
7. transmitters f the communications Rated maximum Separation distance according to frequency of transm ter output power m Mu 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 124 P d 124 P d 234P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 ug 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recomi ended separation distance din meters m can be estimated using the equation applicable to the frequenc is the maximum output power rating of the transmitter in watts W according tc manufacturer NOTE 1 NOTE 2 At 80 MHz and 800 MHz the separation distance for the higher fre These guidelines may not apply in all situations Electromagnetic pr absorption and reflection from structures objects and people of the transmitter where P the transmitter lency range applies agation is affected by Cerebral State Monitor CSM DFU Page 33
8. 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 CSM 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 ratios called alpha cx and beta B Both of these show a shift in energy content from the higher to the lower frequencies during anesthesia The relationship between these quantities is also analysed as a separate parameter B a In Es su P In E su ratio E ratio 6 12 Hz Ey og a 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 p i FUZZY LOGIC E EG CLASSIFIER Cerebral State Monitor CSM DFU Page 14 5 3 CSI Scale The CSI is a unit less sca
9. Cerebral State Monitor Model CSM 2 User Manual eB danmeter 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 com www danmeter com Rx only Table of Contents Abo tthis Manual s t ine tte tone tede tele tote fidere de titi 1 1 1 Device descriptio 4 raider ettet tert been ere io de et tired e 1 1 2 Indications for Se 2d deett iere certe eter ete tere tete ierat 1 1 3 List of Symbols Installation and PreparatioFi oett iet ente te tete e RR PA RR ERR neces 2 Skin Preparation and Sensor Positioning seen 3 Description of the Device 4 1 General OVetVieW ina retention rtet rene a aad 4 2 Keys and Controls OVelVleW ied cette teni dee i dee red eie eget 5 4 3 Light Indicators 4 4 Description OF KEYS sects asset aede tme iei e ran eiae ene serena ed 6 4 5 Operation Display Modes ettet itenim etel cnini retention 7 4 6 Setup Menu 47 4 8 4 9 Principle of Operation 5 1 High Quality Am plier 212 nen nt imet ten ien 5 2 Measurement Principle 5 3 CSSeale aec ettt e rede temi tee e lutei e te o A e 54 EMG mite iei ded aedes ibo ibd sends 5 5 Burst Suppression Indicator 5 6 Artifact and Noise Cohtrol iiit ite etienne ied rem aet CSM Battery CSM Power Operation ntes 6 1 Using CSM Power and CSM Rechargeable Batteries Data Recording via COM kink
10. SB IS 2 4 GHz Up to 10 meters 1 3x 0 7 High Low with user selectable lim Automatic 0 10kOhm measurement current 01 UA Rechargeable NiMH or 9V Alkaline 6AM6 IEC 6LR6 1 ANSI 1604A 30mA typical 30h stand alone 18h transmitting wireless See table in section 6 1 4 Hours CSMX04 only 4 6 ounces 130 g with battery 4 6x2 7x1 2 Internal power supply Class II typ BF continuous use Danmeter Neuro Sensors 77 with 14 split Velcro strip 1 7x0 9 Data recording 18 hours Temperature 50 104 F Rel humidity 30 75 Air pressure 700 1060 hPa Temperature 50 104 F Rel humidity 30 95 Air pressure 700 1060 hPa If transport without sensors 4 158 F Cerebral State Monitor CSM DFU Page 21 9 Accessories CSMX04 CSMX05 CSMX06 CSMX09 CSMX10 CSMX11 CSMX12 CSMX19 CSMX18 CSMX13 DMX004 DMX013 DMX005 DMX007 CSMIUS 10 Maintenance Routine Maintenance CSM rechargeable battery CSM Power Charger Patient cable Carrying case Service manual English CSM Link Software CSM Link RS232 CSM Link USB CSM Link PHILIPS VOI Velcro Strip 1 7x0 9 RS 232 cable USB cable CSM Procedure Pack Clip for patient cable User Manual 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
11. aser If any product requires service during the applicable warranty period the purchaser should communicate directly with the local Danmeter service center 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 judgment 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 warranty is in lieu of all other warranties expressed or imp
12. ate Monitor CSM is intended for use in the electromagnetic envii customer or the user of the CSM should assure that it is used in such an enviro nment specified below The ment Emissions test Compliance Electroma netic environment guidance RF emission Group 1 The Cerel al State Monitor CSM uses CISPR 11 RF energy nly for its internal function Therefore its RF emissions are very low and e not likely to cause any interferen gt in nearby electronic equipmen RF emission Class B The Cere ral State Monitor CSM is CISPR 11 suitable fi use in all establishments ess z including mestic establishments and RUMOR OUS DR Not Applicable those dire tly connected to the public IEC EN 61000 3 2 low voltac power supply network that Voltage fluctuations flicker emissions IEC EN 61000 3 3 Not Applicable supplies purposes Jildings used for domestic Guidance and manufacturer s declaration electromagnetic immunity The CSM is intended for use in the electromagneti c environment specified belov of the CSM should assure that it is used in such an environment The customer or the user 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 synthetic material the relative
13. c immunity The CSM is intended for use in the electromagnetic environment specified belov of the CSM should assure that it is used in such an environment The customer or the user Immunity test IEC EN 60601 test level Compliance level Electrc guidan lagnetic environment a Portab commt be use the Ce includi recom calcula applice trans and mobile RF iications equipment should no closer to any parts of bral State Monitor CSM j cables than the ended separation distance sd from the equation le to the frequency of the ter Cerebral State Monitor CSM DFU Page 31 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 3 Vrms 3 V m Recom MHz g 2 5 GH where power watts trans the rec distan Field s trans electrc should level ir Interfe vicinity the foll ended separation distance 2N P 2X P 80MHz to 800 34 P 800 MHz to is the maximum output ating of the transmitter in 1 according to the ter manufacturer and dis mmended separation in meters m engths from fixed RF ters as determined by an iagnetic site survey a e less than the compliance ach frequency range b ince may occur in the f equipment marked with wing symbol t9 NOTE1 At 80 MHz and 800 MHz the higher frequency range a
14. d 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 artifacts e Do not allow fluids to spill or drip on the monitor IN 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 artifacts or elevated CSI values Exclusion criteria are weight less than 70 or more than 130 of ideal body weight neurological disorder and recent use of psycho active medication including alcohol 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 from the date of delivery by Danmeter to the first purch
15. dance of the white or black sensors exceeds 1kQ the SQ will fall gradually Poor impedance conditions may cause the SQI to fall to 50 Artifacts 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 neuro 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 neuro sensors If possible move disturbing device away from the neuro 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 e CSI is higher than expected Check anesthetic 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 e Sl rises along with EMG High levels of facial muscular or electromyographic EMG activity can elevate the 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 re
16. ion of EEG signals of the anesthetized or sedated patient in all areas of the hospital Caution Federal law U S A restricts this device to sale distribution and use by or on the order of a physician Cerebral State Monitor CSM DFU Page 1 1 3 List of Symbols Type BF equipment 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 I Bl 2 Installation and Preparation The Cerebral State Monitor system CSM007 includes the following Cerebral State onitor CSM Wireless Link Patient Cable CSM Software CD Rechargeable Battery User manual this doct nent Power Adapter 2 pieces Power Cable 2 pieces RS 232 Cable l B Cable Carrying case Velcro strip 1 7x0 9 Clip for patient cable For replacement accessories refer to chapter 9 Note The performance of the CSM monitor by EEG acquisition processing and calculation of the CSM parameters and waveforms in the CSM monitor are ONLY guaranteed by the manufacture when using the CSM Procedure Pack part no DMX005 The possibility to use standard ECG electrodes is NOT RECOMMENDED Cerebral State Monitor CSM DFU Page 2 3 Skin Preparation and Sensor Positioning To ensure low sensor impedance clean skin with mild soap and water is recommended as a skin cleanser Note Alcohol is not recommended as a skin cleanser
17. it leaves a film layer that may cause high sensor impedance If alcohol is used ensure 30 second dry 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 Procedure 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 of the three sensors from your CSM Procedure Pack according the diagram below Middle of forehead Left side of forehead Mastoid left side Shown above is a left sided setup right sided is also acceptable Place sensors at the side farthest from the surgical area XS AS The advanced signal processing of the monitor ensures that a deviation 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 fibers are present in order to achieve the best quality signal Note Once the sensors have been secured on the skin attach the color coded wires on the patient cable to appropriate se
18. ithin range Cerebral State Monitor CSM DFU Page 10 Device Information Select submenu BS O ZS Device information 1 Info Link Log Info e Serial number e SWversion e CSlversion 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 total no running hours 48 Events Pressing the Set Event key 6 results in a continuously numbered event with no description displayed Pressing the Event Type key brings up the following selection menu BS 0 47 CSI Event types 1 Induction Intubation Maintenance The following options event descriptions 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 49 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 informa
19. laxation 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 artifacts are present the CSI should be interpreted with caution e 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 CSM Link are connected but no data appears on recording terminal Check that the RS 232 or USB cable 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 center See section 14 Together with the error code an audible alarm is activated 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 PEIN Turn off the CSM Disconnect patient cable Turn on the CSM When
20. le from 0 to 100 where 0 indicates a flat EEG and 100 indicates EEG activity corresponding to the awake state The range of adequate anesthesia 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 among the CSI the clinical state and the OAAS score is shown in the table below OAAS NW 4 Ul Clinical State Responds readily to name spoken in normal tone CSI Clinical State OAAS 90 100 Awake 5 80 90 Drowsy 4 60 80 Light anesthesia or sedation 3 Range considered as adequate for 2 1 40 60 surgical anesthesia Deep anesthesia in most cases 1 10 40 accompanied by burst suppression Close to coma BS burst suppression lt 1 0 10 larger than 75 When CSI is below 3 the EEG is practically iso electric The prediction probability Pk between the CSI and the OAAS was 0 92 The OAAS score correspond to 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 Observers Assessment of Alertness and Sedation Cerebral State Monitor CSM DFU Page 15 54 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
21. lied 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 center to obtain a unique Service ID number for the CSM e Before returning the device for service please carry out the following Carefully describe what is wrong with the monitor Clean the monitor before shipping it Use only original packaging for return shipment Include all accessories used when error occurred except used neuro sensors Return the Monitor to Danmeter A S or appropriate service or distribution center 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 Notes Cerebral State Monitor CSM DFU Page 29 15 Technical description Guidance and manufacturer s declaration electromagnetic emissions The Cerebral St
22. nsor 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 2 3 is Emoy GREEN Power g adapter On Off 4 Display area 2 6 Mute Set Event key key 7 8 Display Event Type key key Cerebral State Monitor CSM DFU Page 5 4 3 Light Indicators 2 RED Error light Lights up when neuro sensor error situations are detected 3 Lights when power adapter is connected 4 A 000000000000 Description of Keys 1 Power On Press once 1 Power Off Press and hold until Power Off bar disappears 1 Wireless Link connection disconnection or reconn tion Press twice within 1 second 5 Mute key Mutes alarms 6 Set Event key Set link 7 Display key Changes between graphical and information scree 7a For immediate impedance update Press down mly for one second 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 se values 9p 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 with display A Switch between display A B C D and E by pressing the Display key
23. 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 Reflex reactions to painful stimuli during surgery Lack of muscular relaxation Muscular rigidity caused by some opioids analgesics 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 interference 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 anesthetic 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 reado
24. on Connecting to CSM Link when the CSM radio is inactive 1 2 3 4 5 6 za 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 inactivated Cerebral State Monitor CSM DFU Page 20 8 Specifications EEG s nsitivity Noise CMRR Input npedance Samp rate CSI ar 1 update EMG BS Digita output Wirele s range Disple size Alarm Artifa rejection Sensc impedance range Batte Suppl current Max attery lifetime Alkaline Max attery lifetime Rech geable Reche ge time Weigh Dimer sions Classi zation Sensc s Cable 2ngth Moun ng options Memc y Envirc iment Operation Envirc iment Transport and s vrage 400yV lt 2UVp p lt 0 4UV RMS 1 250 H gt 140dB gt 50Mohm 2000 samples sec 14 bits equiv ent 0 100 Filter 6 42 Hz 1 sec upde 2 0 100 logarithmic Filter 75 85 Hz 1 sec update 0 100906 Filter 2 42 Hz 1 sec up ate Wireless to RS232 link or U
25. on of the manual was originally drafted approved and supplied by Danmeter A S in English Before 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 Device description The Cerebral State Monitor CSM is a non invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness LOC in all areas of the hospital Based on EEG an index CSI is calculated which is used in the estimation of LOC The CSM displays the CSI but does not perform any data interpretation i e all data interpretation is performed by a physician 1 2 Indications for Use The monitor is intended for use in monitoring the hypnotic state of the brain by data acquisit
26. pplies NOTE 2 These guidelines may not app y in all situations Electromagnetic pr absorption and reflection from structures objects and people pagation is affected by Cerebral State Monitor CSM DFU Page 32 a Field strengths from fixed transmitters such as base stations telephones and land mobile radios amateur radio AM and F broadcast cannot be predicted theoretically with accuracy To environment due to fixed RF transmitters an electromagnetic site If the measured field strength in the location in which the CSM Is RF compliance level above the CSM should be observed to verify r performance is observed additional measures may be necess relocating the CSM b Over the frequency range 150 kHz to 80 MHz field strengths shou yr radio cellular cordless radio broadcast and TV ssess the electromagnetic irvey should be considered sed exceeds the applicable rmal operation If abnormal y such as reorienting or be less than 3 V m Recommended separation distances between portable and mobile RF communi CSM ations equipment and the The CSM is intended for use in an electromagnetic environment in which radiate controlled The customer or the user of the CSM can help prevent electromagnt maintaining a minimum distance between portable and mobile RF communicatic and the CSM as recommended below according to the maximum output power RF disturbances are ic interference by s equipment
27. s a5 aeter ht Cena ra ODE OTt Data Recording via CSM Eink 3 endi oe hit ita a DERE DER Tal CSM Link Software 72 UN c Specifications crane eum ettet unte icut edm ee ten Accessories Maintenance oerte tr tea pedet eed Decii rta danced dun Troubleshiootilig s exces qu ar n eR eR read anat eread eire ier System and Error Messages Safety and Wart anty sists e rote em tni ana le eme tra Ha e id eu a GUT M D TQ dE Hae ia IUE Seivice and Contacts ac arters nitas nir tanta tanque dat tdi re Technical descriptiorizzs sitet tore prr toe pra tre Didi o ee tede tede 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 US English PN 561105003 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 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 CAN CSA C22 2 No 601 1S1 94 CSA 601 1 Amendment 2 1998 CAN CSA 601 2 26 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 versi
28. s 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 guide for biomeds Cerebral State Monitor CSM DFU Page 23 11 Troubleshooting e 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 e Rechargeable Battery seems to have a diminished user time 1 Turn on the monitor without patient cable and no CSM Power attached 2 Wait until the monitor turns off rechargeable battery discharged 3 Connect CSM Power for minimum 4 hours to fully recharge e Sensor alarm Red Error light turns on and CSI BS and EMG replaced by Check all neuro 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 neuro sensors are disconnected or badly connected Replace faulty sensor e Blanked index but why Sensor impedance too high If sensor impedance is gt 5kQ the CSI BS and EMG will be blanked displayed Check that neuro sensors are not dry Check that the skin has been cleaned properly Clean and prep skin as described in section 3 and attach new neuro sensors Signal Quality Index SQI low If the impe
29. te 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 at normal operation Wireless Link Backlight level Life time hours Note OFF OFF 10 5 Using 9V alkaline disposable OFF 1 9 0 batteries the battery life time OFF 2 7 0 indicated in the table can be ON OFF 10 0 multiplied by 2 to 3 ON 1 85 ON 2 6 5 Cerebral State Monitor CSM DFU Page 17 CSM Power c f Ww Connect to power cable Wi i EN Vu il AMAN Connect to CSM Power connection Insert the CSM rechargeable battery as indicated Connect power cable to outlet 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 operated while the CSM battery is charged If power is disconnected the CSM will continue running on the CSM battery Qu OO ISS 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 CSM rechargeable battery CSMX04 is used it will charge automatically while the electrical power is connected ONLY CSM Battery CSMX04 will be charged in the CSM monitor Cerebral State Monitor CSM DFU Page 18 Data Recording via CSM Link 71 CSM Link Software The real time data capturing software for the
30. the start up check has finished connect the patient cable for normal operation 13 Safety and Warranty Warnings Not to be used in the presence of flammable gases explosion risk When used with High Frequency HF surgery please note the positioning of the neuro sensors see page 3 In order to reduce the hazard of burns the neuro sensors should not be located between the surgical site and the electro surgical unit return neuro sensor 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 The conductive parts of neuro sensors and their connectors including the neutral neuro sensor should not contact other conductive parts including earth Precautions The monitor should be used in conjunction with other patient monitoring parameters and clinical signs This will ensure the optimum balance of the anesthesia sedation administration 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 in serious injury to persons and instrument component damage Disconnect from battery power when performing maintenance Should an instrument be dropped or severely shaken it should immediately be taken out of service and inspecte
31. 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 current CSI goes higher than 60 the CSM monitor alarm sounds Same functionality is present for Alarm Low 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 8 Battery about 50 percent charged EEA Battery charging when icon animates mE Battery fully charged if not animated Note ONLY CSM Battery CSMX04 will be charged in 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
32. tion 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 B 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 the number of artifacts during the last minute The electrode to skin impedance is included in the SQI calculation Higher electrode to skin impedances reduces the SQI Only electrode to skin impedances at 1 and 1 KQ will result in a SQI at 100 This quantity is displayed 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 1k 2 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
33. uts means that the EEG has been iso electric during 20 of the last 30 seconds 5 6 Artifact and Noise Control The artifact 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 artifact 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 CSM Power Operation 6 1 Using CSM Power and CSM Rechargeable Batteries The CSM can be operated in two different modes e Battery operated e CSM Power operated Marning Only standard CSM rechargeable battery CSMX04 or alkaline batteries must be used Battery operation Alkaline batteries e Always use new Alkaline batteries to ensure best results e Insert battery correctly CSM Power operation and CSM rechargeable batteries Warning Only for use with adapter CSMXO5 Ault Inc Model MW 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 dock 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 No
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