- Frank`s Hospital Workshop
Contents
1. According to the above guideline the unit falls under the risk class IIa In order to protect both patient and personal the unit must be grounded The unit complies with the protection class I This way it will be grounded through the protective conduc tor Any usage of mains connecting facilities which can cause the protective conductor to be interrupted is forbidden The unit is defibrillation proof provided the patient s cable supplied with the accessories is used During defibrillation one must not touch the patient the equipment or the bed In case that the unit is used for ECG acquisition from patients with heat pacemakers or if a further electri cal simulator is used simultaneously the is no kind of endangering Naturally simulator should be used in a reasonable distance from the electrodes In case of doubt the patient should be disconnected from the elec trocardiograph The unit should be operated inside rooms protected against vibrations and corrosive gases and should not be exposed to direct sun radiation or heat from other sources The unit works at ambient temperatures of 10 C 40 C For the safe operation to obtain keep the unit free from condensation water In order to prevent that make the unit acclimate after relevant temperature alterations Once temperature and atmospheric humidity have compensated the unit can be operated The unit is not intended to be run inside explosion hazardous locations I2. As a variant the unit can be supplied with automatic ECG measurement function or automatic measurement interpretation using the HES analysis program by the Medizinische Hochschule Hanover If desired itis also possible to unlock the ECG measurement interpretation function in the client s house BIOSET 9000E is foreseen for ECG recording in the ambulant practice and clinical routine Owing to its small dimensions low weight and possible battery operation it is suitable for home visits and emergency medicine 1 2 Unit Design BIOSET 9000E is a compact unit with horizontal upper side The casing consists of two plastic shells with easy to clean surface The lower part is the chassis which includes the most significant components The main components of BIOSET 9000E are Lower casing part with circuit board with the entire electronic system recording unit as a separate module Upper casing part with keypad including LEDs The power pack is inside the unit it is a plug in type and can easily be exchanged The software is installed in a flash ROM memory Through the RS 232 interface it can easily be updated PATIENT S AND UNITS SAFETY 2 Patien s and Unit s Safety BIOSET 9000 is in accordance with the Medical Products Act MPG and the Directive 93 42 EEC on Medical Devices MDD and meets thus the safety requirements as per EN 60 601 1 IEC 601 1 and the anti interference requirements as per EN 60 601 1 2 EMC act
3. C max 95 at 40 C 25 C to 55 C 10 76 to 100 thermoreactive thermoline 210 mm wide 8 dots per mm gt 40 mm channel 8 dots per mm 20 dots per mm at 50 mm s 40 dots per mm at 25 mm s 200 dots per mm at 5 mm s automatic write centring 0 05 120 Hz 5 30 96 recording paper paper type recording speeds 9 3 ECG Section electrode inlets Einthoven Wilson Nehb electrode test number of channels lead programmes PR 1 PR2 PR 3 PR 4 PR 5 progr sequence for AUTOMATIC Mode recording duration per lead programme application unit input resistance time constant overload protection rejection factor IMMR equivalent interference voltage p p superposed DC voltage transmission range sensitivities muscle filter mains frequency filter drift filter ADS AD conversion pacemaker TECHNICAL CHARACTERISTICS continuous stationary 400 sheets 210 mm wide 60 m long with grid imprint red side logo sheet control marks thermoreactive order No 2700 000 021 5 25 50 mm s 5 R L F N C1 C2 C3 C4 C5 C6 C12CNI C2 CN2 C3 CN3 monitoring before and during ECG acquisition 12 6 I IL III aVR aVL aVF V1 V6 12 standard leads I IL HII aVR aVL aVF limb leads V1 V6 chest wall leads aVL I aVR II aVF III Cabrera I IL WI D A J limb and NEHB leads PR2 and PR 3 time synchronous optional 1 4 sheets to be selected in the unit Setup
4. 9 oon O ak wh TECHNICAL CHARACTERISTICS 9 Technical Characteristics BIOSET 9000E 9 1 General Data operation mains voltage range power drain mains frequency range mains connection battery safety degree electrical safety application class potential equalisation connection classification acc to Directive 93 42 EEC MDD mains and battery 230 V 10 AC 22 W 50 Hz 60 Hz mains lead plug in type power pack nickel metal hybride 12 V 2 1 Ah IP 20 acc to DIN 40050 protective class I unit with internal power supply CF type at the ECG unit class Ila Design according to the anti interference requirements as per EN 60601 1 2 EMC act including radio anti interference filter dimensions w x d x h weight with battery modes of operation mains operation battery operation operating time with battery Application conditions acc to DIN IEC 721 ambient temperature max permissible humidity Transportation temperature range relative humidity Long term storage temperature range relative humidity 9 2 Recording Unit writing method writing element writing width resolution of registration in Y direction resolution of registration in X direction zero adjustment frequency range 358 x 340 x 98 mm approx 5 5 kg permanent operation short time operation min 1 h for 6 channel recording at 25 mm s 10 C to 40 C 95 without condensation 25 C to 70
5. F insulated 22 x 50 MOhms 3 2s for voltage pulses from defibrillators and cautery apparatuses automatic intermediate settlement gt 100 dB lt 20 uV lt 0 3 V 0 05 150 Hz 5 10 20 mm mV x 5 fg 35 Hz slope 4 6 dB Okt adaptive digital filter 50 60 Hz 2 damping gt 20 dB high pass limit frequency 3dB 0 6 Hz 0 1 Hz signal delay 1 1s enabled default can be disabled in the unit Setup scanning frequency 1000 Hz resolution 13 bit recognition marking pacemaker voltage on body surface 700 mV pacemaker pulse width 2 ms also double chamber pacemakers TECHNICAL CHARACTERISTICS heart frequency indication measuring range 30 240 min recording paper print out of average QRS sound can be switched off 9 4 Operation Section keyboard plastic foil keypad wipe resistant LED indicators 9 5 Standard Interfaces signal inlet TTL level registration mode mode 1 L registration start H registration stop mode 2 L registration start automatic registration acc to time or number of sheet selected 9 6 Optional Interfaces Analogous signal outlets number of outlets 3 outlets short circuit resistant asymmetric frequency range 0 05 250 Hz sensitivity 1 00V 1mV 0 50 V 1mV 0 25 V 1 mV sensitivity change synchronous to inlet sensitivity channels time synchronous DA converter 8 bits modulation range 4V QRS trigger digital outlet signal 5 V 150 ms time syn
6. a hint on TACHYCARDIA Global measured values P duration P Q interval QRS duration Q T interval QTc as the Q T interval corrected acc to BAZETT as well as this relative Q T interval in percent normalised to a Q T duration of 0 39 sata heart frequency of 60 beats per minute acc to HOLZMANN Intervals marked by a star differ from the normal values Frontal vectors in the frontal plain longest vectors for P wave QRS complex and T wave in the Cabrera circle indication of the position type for the QRS vector Rhythm Indication of rhythm with hints e g for sinus rhythm sinus arrhythmia ventricular extrasystoles arterial fibrillation The rhythm analysis considers R R distances P and T wave forms morphology of QRS complex and coupling relations Rhythm diagram brief survey on the beat sequence of ECG cycles with a statement on how many beats have been in cluded by the 10 s recording into the evaluation meaning of the characters letters y normal beats included in the mean taking process for the representative cycle Not included in the message 72 3 4 the respective beat is an extrasystole or an aberrant complex each figure stands for a different type B base line fluctuation PT aberrations of P or T contours O aberrations of P and T contours PR too short intervals towards the preceding and following cycle x other variations vr position at the beginning or end of the 10 sec ECG U
7. aberrant complex complex with spikes coy pacemaker triggered beat The distance between characters represents in the roughened grid the R R distance Findings found disturbance in the raw data ECG including qualification slight medium or heavy Indication of QRS waves occurred in limb EX leads I II HI aVR aVL aVF and chest wall BW leads V1 V6 interpretation of significant ECG measured values for morphologic individualities e g Q wave in certain leads R losses Delta waves ST changes repolarisation disturbances by inner and outer layer type as well as graduation 6 2 ECG MEASUREMENT AND INTERPRETATION QT Dispersion In the HES ECG the QT dispersion is indicated as the dispersion of earlier repolarisation measured from the QRS beginning up to the extrema of the T wave QT peak dispersion The QT dispersion shows the standard deviation of the moments of T extrema together with the absolute value of the maximum time difference of these values as well as the number of the leads used for calculation applied to the 8 measuring leads QRS T Evalation Interpretation of the representative cycle after diagnosis of infarction hypetrophy bundle branch block etc ECGs of children under 14 are not subjected to QRS T evaluation in order to avoid misunderstandings Finally the ECG is subjected to an overall evaluation In addition to the analysis results lead II of the analysed ECG is shown in unf
8. after 10 seconds of trouble free ECG recording This is the case if after the indicator s blinking in rhythm with the heart rate one waits another 10 sec M9 before starting the mesurement or until the LED in the indication field O stops blinking As long as a 10 sec ECG which can be evaluated has not been recorded the analysis cannot be started i e the analysis key is locked acoustic signal on pressing within the rejection time Subsequently the right hand LED will blink and the patient s sex must be entered 12male 2 female Pressing the key starts the automatic analysis The progress of the automatic analysis is indicated by the PR1 LED later by PR2 and PR3 The analysis takes 4 to 5 seconds After completion of the measurement the results are printed out automatically Depending on the unit setup chapter 7 the measured value table and the analysed ECG can be printed out in various formats ECG MEASUREMENT AND INTERPRETATION 6 2 Analysis results The following information is given out after the patient s data Heart frequency in beats per min In case of adults for a heart rates of more than 100 beats per min a hint on TACHYCARDIA will be inserted and for rates of less than 60 beats per min a hinton BRADYCARDIA For children a hart rate 60 beats per min gives a hint on BRADYCARDIA a hart rate 60 to 70 beats per min gives a hint on AGE CONDITIONED BRADYCARDIA a hart rate gt 120 beats per min gives
9. regularly clean it by means of a soft and non fuzzy cloth using a mild soap solution for a necessary disinfection use Gigasept or the like Sterilisation by steam hot water or air is inadmissible Note do not use ether petrol propyl alcohol or acetone prevent fluids from getting into instrument or connecting sockets 10 1 11 Maintenance Checks MAINTENANCE CHECKS In the interest of the instrument s permanent availability and in order to guarantee the required safety for both patient and operating personnel in handling the BIOSET9000 inspections and checks are specified If deficiencies concerning safety and serviceability are thereby detected inform your service partner In case of defects or function deficiencies of the unit which may impair the safety of both patient and operator the unit may be used only after elimination of these faults Service partners can get a service manual from von Berg Medizinger te GmbH Checking when Putting into Operation Daily Checks Periodic Checks new instruments are installed checked and handed over in a functional and safe condition by the manufacturer or his service partner prior to using the unit make a visual check of unit cables and electrodes for damages and other defects a close functional test should be accomplished every 12 months perform a safety check as per IEC 601 1 and IEC 601 2 25 for a function test advantageously use an ECG simul
10. to be entered in the following way ddmmyyhhmmss Use the following keys to enter the digits F Tro l for 2 for 3 for 4 for 5 for 6 for 7 for 8 for 9 for 0 Every input is confirmed by a beep In any case it must be 12 digits Changes and corrections require complete reinput of the digits Optional print outs of measurement and interpretation Settings for print outs in addition to the measurement interpretation results rep cycles Eposa 4 PRI yes permanent light of active condition meas val table Ejpbsanuy 7 PR2 yes permanent light of active condition Programming of the also printed ECG acc to measurement interpretation results print ECG Eposa 4PR3 yes permanent light if ON number of chann Esk sanuyf 7 EPRA PRI I2ch permanent light if ON PR243 6ch ECG recording using the PR1 12 channels or successively using PR2 and PR3 blinking LEDs speed sensitivity UNIT SETUP parameter key blinking variant selection change LEDs accepted number of sheets E esas 9 4 PRS 1 sh each 2 sh each 3 sh each permanent light if ON 4 sh each Since the ECG memory can store max 10 seconds it is advisable to select only 1 or 2 sheets for recording at 25 mm sec and only 1 sheet for 5 mm sec speed Ejhbsanuy 4PRI PR5 curr speed 7 5 mm sec 25 mm sec permanent light if ON 50 mm sec sensitivity E bsanuy 77 4PRI PR5 currsty 5 mm m
11. 6 ECG Measurement and interpretation The ECG measurement and interpretation is executed by means of ht HES analysis program By the buyer s desire it can be unlocked either in his premises or before despatch ECG evaluation requires the I II and V1 to V6 leads were acquired over a period of 10 seconds the III aVR aVL and aVF leads are calculated To obtain reliable analysis results take care that ECG recording is performed without interference Further more analysis is not possible with leads according to Nehb and in case of electrode faults or intermediate settlements nclusion of filters is as a rule the worst way of elimination of disturbances because this is most likely to falsify the ECG Only the unfiltered signal is analysed With muscle and mains filter on there would be differences between the representative cycles unfiltered and the ECG filtered The analysis program considers the patient s age and sex 6 1 Measurement and interpretation Before starting the analysis the patient s age and sex must be entered as patient s data use the keys 1 0 Therefore press key On blinking of the left hand LED below Y enter the age in years and confirm by repeated pressing this key For children under 4 years the LED below M will now start blinking and the months of life of the unfinished year must be entered Confirm this input by press ing key as well The measurement can be started
12. OPERATING MANUAL 6 12 Channel Electrocardiograph BIOSET 9000E C 0123 von Berg Medizinger te GmbH E 0802 TABLE OF CONTENTS Table of Contents 1 GENERAL yasni nu 1 1 1 1 Application iiu ete tae Ec ida 1 1 1 2 Unit design teret ec e eife tees 1 1 2 PATIENT S AND UNITS SAFETY eerte 2 1 3 OBERATINGELBMENTS an 3 1 3 1 bu EET 3 1 3 2 Keypad and key functions eese ener 3 2 4 PUTTING INTO OPERATION 25 22 4 1 4 1 Insertion of recording paper sssessssesssssseessesseseesseessssssresseesressesseeses 4 1 4 2 Application of electrodes sese 4 1 4 2 1 Resing EEG ini ie 4 1 42 2 Exercise ECG ande ae beret be iet tte e estates 4 3 4 3 Switching the unit on and off sss 4 4 4 3 1 Mains Operation neina a n i Beinahe deal 4 4 4 3 2 Battery Opetatlon sioe eec decet Heat Hep 4 4 4 3 8 Switching ON and OFF esses eene nennen nnne 4 4 3 ECG RECORDING 2 u en 5 1 5 1 Recording in manual mode eee 5 1 5 2 Recording in automatic mode seen 5 2 5 3 Recording with ergometry remote start eene 5 3 5 4 Recording a test REG 5 4 6 ECG MEASUREMENT AND INTERPRETATION 6 1 6 1 Measurement and interpretation esuesseessessennnesnesnnennnennennnennnn nenn 6 1 6 2 Analysis results 4 iie p eee te RR e eed ictus 6 2 7 UNLDSEBUP a ae tatione docct Du Sob e
13. V 10 mm mV permanent light if ON 20 mm mV blinking LEDs speed sensitivity As long as the system is in SETUP mode any changes can be made Setup is closed by simultaneous pressing of Closing saves all parameters settings After that all settings are automatically printed out o The indication stops blinking The printout of the unit setup gives a detailed overview of all settings and if existing special variants Preferably it should be kept with the operating manual INTERFACES 8 Interfaces A It must be provable that any additional equipment to be connected to the unit s analogue and digital interfaces are in accordance with the relevant EN specifications i e EN 60950 for data processing equipment and EN 60601 1 for electro medical equipment Furthermore all combinations must be in accordance with the system standard EN 60601 1 1 All non medical units must be connected to the same circuit In case of questions please contact your local dealer or the technical service 8 1 Analogous 1V Outlets Connection scheme seen onto socket d 2 GND 9 o iu 3 outlet 2 8 o 9 4 QRS triggeroutlet o 3 7 o 2 5 6 o E 1 6 7 outlet 1 8 outlet 3 9 Allocation of outlets of programmes 1 5 is desribed in chapter 5 3 8 2 Serial Interface RS 232 Connection scheme seen onto plug i 2 RxD Received Data 3 TxD Transmitted Data 4 5 GND Ground 6 Jg 8
14. ammes number of sheets for AUTOMATIC programme every individual lead sequence in MANUAL mode start stop operation or selectable number of sheets or recording time muscle filter ON OFF AC filter ON OFF QRS sound ON OFF drift filter ON OFF language for paper margin imprint and measurement results RS232 mode OFF remote control data transfer from ergometer PC linkage PC Link is an online data transfer format 0002 of HOERMANN ECG recording at change of load stage remote start ergometry date and time setup of optional measurement and interpretation Operation The Setup is opened by simultaneous pressing of Apply these setting only in ready to work condition i e with loaded paper As soon as is blinking the unit is in SETUP mode The individual parameters are set up as follows parameter key blinking variant change LEDs accepted programme programme PR1 speed speed Smm s sensitivity sensitivity Smm mV PR2 PR3 PR4 permanent light of sel programme PR5 25mm s permanent light of selected speed 50mm s l0mm mV permanent light of sel sensitivity 20mm mV 9 E 3 z 3 3 3 e 2 2 a E 2 2 E Ql Ql e Ql Ql Ql 6 e ci o 5 UNIT SETUP parameter key blinking variant selection change LEDs accepted no of sheets AUT e speed 25 Isheet 2sheets 3sheets Asheets Since the ECG memory accepts a maximum of 10 seconds it is re
15. at 25mm s Discharge of the power pack is indicated by both acoustic and optical warning Once the charge is low 20 96 the indication will change into permanent light and a warning sound comes in certain intervals After these signals have come there is only a few time left for recording Once the power pack is discharged a short permanent sound comes and the indicator blinks After that the unit goes automatically off In order to get a maximum operation time per power pack charge the unit has a sleep mode That means that after an acoustic warning the unit will always get off automatically after no key was pressed for 4 minutes If the recording process lasts longer the unit of course remains on 4 3 3 Switching ON and OFF o Use the key to switch the unit on After completion of a switch on routine the selected programme usually PR1 is activated provided that the electrodes have been properly arranged For information on electrode faults refer to chapter 5 1 Use the key to switch the unit off ECG RECORDING 5 ECG Recording ECGs can be recorded under MANUAL with PR1 PR5 and AUTOMATIC After switching on with electrodes applied the programme selected in the setup usually PR1 is indicated by permanent light of the relevant green LED 5 1 Recording in Manual Mode The following parameters can be changed prior to or during recording The active selection is indicated by the relevant LED Use the k
16. ator if using the internal simulator patient cables and ECG input section must be connected before starting the check Check the following patient cable and electrodes visual inspection all printed curves and parameters simulate the external start function and monitor signals full functionality of the patient cable Therefore remove each electrode one after the other from the simulator An electrode fault must be indicated in every case Evaluate the recording test see below itis also possible to check recording quality Therefore open and close the unit Setup as described in chapter 7 This will record the settings plus three parallel oblique test lines which allow assessment of the printing quality In case that national regulations require more extensive checks these must be performed Thermoline Power Pack in case of contamination of the thermoline the printing edge may be cleaned with utmost care using an alcohol soaked cotton swap Make sure that the unit is unplugged and no patient is connected the power pack is service free If with battery operation a reasonable recording time is not longer achieved contact a service partner Te T ENVIRONMENTAL PROTECT WASTE REMOVAL 12 Environmental Protection Waste Removal Neither the use of the units nor of its accessories causes harmful emissions of waste substances The following information applies to all equipment manufactured by us so
17. chronous to ECG inlet Computer interfaces type RS 232 C 9 pole function PC Link for PC coupling data communication with SECA 100 Ergometrics 900 Variobike550 Variotrainer500 update programming TECHNICAL CHARACTERISTICS 9 6 Measurement Software HES MWZ EKG Evaluation program for analysis of resting ECGs time synchronous acquisition of the 12 standard leads ECG measurement analysis of rhythm and form rhythm analysis based on leads II V1 V6 output of complete analog curves or representative cycles with measurement marks output of the measure value report output of the ECG interpretation Cleaning Disinfection 10 Cleaning Disinfection Only clean and disinfect the instrument in switched off condition and disconnected from the mains Make sure that cleaning and disinfectant agents are only used in compliance with the manufacturers provisions e g in due dilution Electrodes patient cable and accessories Unit to be cleaned after use acc to in house specifications General rules clean electrodes with running hot water after use disinfect electrodes and cables by means of a disinfectant soaked cloth e g Cidex Gigasept Note do not dip plug connectors of cables into fluids the use of acetone alcohol chloroform or strong solvents results in flexibility loss of and damage to cable gas sterilisation is possible sterilisation by hot air and steam is inadmissible
18. commended to select only or 2 sheets for a recording speed of 25 mm s or sheet for 5 mm s MAN recording speed 5 lsheet 2sheets se 10s selectable recording speed without sheet control i e recording must be stopped manually 1 2 sheets sheet control i e recording stops automatically after selected number of sheets 5 10s time control i e recording stops automatically after selected recording time tL O muscle filter ae muscle filter on permanent light if ON or AA O AC filter pA AC filter on permanent light if ON or QRS sound QRS sound on permanent light if ON or drift filter speed 50 on or language D a Q sensitivity 5 1 German 2 English 3 Russian 3 4 French 5 Czech Instead of 3 Russian the unit having the unit No includes according to page 0 1 Slovak Romanian Instead of 4 French the unit having the unit No includes according to page 0 1 Slovak Romanian Instead of 5 Czech the unit having the unit No includes according to page 0 1 Slovak Romanian with interpretation texts in English UNIT SETUP parameter key blinking variant selection change LEDs accepted RS 232 mode sensitiv 20 off remote contr SECA100 Ergometrics PC Link Erg y recording oHe speed 525 0 lsheet 2sheets 10s date and time I HET PRI PR2 Date and time day month year hour minute second have
19. connector 6 Data exchange is the recording of the concerned load for Ergometrics 900 additionally the last measured blood pressure The following ergometers can be connected Unit Cable Item No Ergometer SECA 100 from YOM 99 starter cable SM 2700 050 000 Ergometer Ergometrics 900 connecting cable EL 2100 068 000 Ergometer Variobike 550 connecting cable BO 2100 062 000 Connection of a Monitor Additionally it is possible to connect a monitor using a monitor cable to the 1 V outlet p 3 1 connector 7 unit designation item No EMC 1000 monitor elmed monitor cable EM 2500 072 000 The 1 V outlets are allocated to the following recording channels standard outlet 1 outlet 2 outlet 3 PR 1 channel 8 10 12 PR 2 channel 1 2 3 PR 3 channel 2 4 6 PR 4 channel 2 4 6 PR 5 channel 1 2 3 RECORDING A TEST ECG 5 4 Recording a Test ECG For demonstration purposes the unit includes an ECG simulator The simulator can be opened at any time by simultaneous pressing and Now it is possible to record manually or automatically and to easily demonstrate setup variants particularly the effect of filters For safety purposes the recording strip includes the marking Test ECG The simulator can be closed by simultaneous pressing and If a test ECG is desired to demonstrate measurement interpretation proceed as described in chapter 6 1 Input of patient s data 30 years old male ECG MEASUREMENT AND INTERPRETATION
20. el as well In case of use of an ECG suction electrode system please refer to the advice given in chapter 4 2 2 In the following there is an overview on the standard arrangement of electrodes APPLICATION OF ELECTRODES Einthoven and Goldberger Limb Leads Electrode Code Colour Electrode Position Lead Linkage of Electrodes R L LF L F 2 N F RF R F 2 RL R L 2 Wilson Chest Wall Leads Electrode Code Colour Electrode Position white amp red 4th interspace RH sternal border white amp yellow 4th interspace LH sternal borde white amp green between C2 and C4 white amp brown 5th interspace LH midclavicular line white amp black LH anterior axillary line on altitude of C4 white amp violet LH central axillary line on altitude of C4 Lead Linkage of Electrodes CI CT C2 CT C3 CT CT R L F C4 CT C5 CT C6 CT a APPLICATION OF ELECTRODES Nehb Leads Electrode Code Colour Electrode Position CNI C1 white amp red 2nd rib RH sternal border CN2 C2 white amp yellow LH posterior axillary line on altitude of apex beat CN3 C3 white amp green above apex beat Lead Linkage of Electrodes 4 2 2 Exercise ECG The exercise ECG is acquired using either a suitable ECG suction type electrode system or adhesive electrodes and connected patient cables Defibrillation protection of unit will only be effective if that patient cable specified in accessories is used For use of an ECG suctio
21. eys T to select the lead programmes The following standard 12 or 6 channel programmes can be selected PR 1 I IL III aVR aVL aVF V1 6 12 standard leads PR2 I IL II aVR aVL aVF limb leads PR 3 V1 V6 chest wall leads PR 4 aVL I aVR II aVF III Cabrera PR 5 I IL IIL D A J limb and NEHB leads Change the recording speeds of 5 25 50 mm s using the key Change the sensitivities of 5 10 20 mm mV using the key f Use the key to switch the muscle filter ON and OFF Use the key to switch the AC filter ON and OFF The drift filter for reduction of the zero line variation is usually ON however it can be switched OFF in the unit setup Muscle AC and drift filters act simultaneously for all channels Since the task of filters is it to filter out certain frequency ranges this will result in a change of the ECG curve Therefore one should always try to eliminate the source of fault before switching muscle or AC filter ON Use the key to switch the QRS sound i e the acoustic signal per QRS complex ON and OFF Recording can be started once the indicator blinks in rhythm with the heart rate or if the QRS sound is on the heart rhythm can be heard After electrode application there are polarisation voltages They have first to stabilise before a properly centred recording can be made Start recording by pressing During registration the 1 mV test pulse can be indicated at any t
22. f inflammable gas mixtures e g ether are present explosion hazard cannot be excluded Connection of a PC to the RS232 interface requires the fulfilment of the standards by both PC and periph eral units As per the IEC 601 1 1 compound operation of electrical medical equipment and electrical non medical equipment the PC set must be located in a distance of 1 5 m to the patient In case that the unit s instruction manual does not indicate whether a certain compound operation or cou pling with other equipment is possible any kind of danger a relevant information must be obtained from the manufacturer supplier or from an expert in order to ensure that the total safety of all included units is not affected A situation of danger might arise if more than one unit are connected to the patient or at the electrocardio graph and the sum of all discharge currents would be beyond the permissible limits The units are allowed to be used only by persons who due to their education knowledge and practical ex perience can guarantee proper handling and who have been made familiar with the unit in consideration of the operating manual Only those persons who due to their knowledge and practical experience are fit for briefing people on the handling of the device are allowed to instruct them c This operating manual is part of the electrocardiograph and must always be on hand Strict observa tion of itis precondition for proper use on which b
23. hows a changed signal form being marked additional by a 1 mm marking at the lower paper margin Defibrillation during ECG recording will lead to overload of the ECG inlet To eliminate this overload there is an automatic settlement without time limitation after defibrillation The ECG curve being now visible again shows owing to the switched over time constant a different signal form which is marked additionally by marks at the lower and upper margin of the paper strip After completion of the intermediate settlement the ECG is again recorded with normal time constant Once defibrillation was made this can be done approx 30s after the defibrillation depending on the defibrillation energy This mode can activate itself automatically in case of loose electrodes or other significant artefacts ncase of heavy artefacts or electrode drop the heart rate found may not be correct in every case For pacemaker patients it cannot be fully excluded that the SM pulses for heart rate measurement are taken for ventricular complexes or ventricular complexes are suppressed In any case additional ECG testing is required 5 2 Recording in Automatic Mode In AUTOMATIC MODE 12 standard leads limb leads PR2 and chest wall leads are registered with the registration length 1 to 4 sheets per programme selected in the Setup Recording can be started once the indicator blinks in rhythm with the heart rate or if the QRS sound is on the hear
24. i toon 7 1 8 INTERPA C ES at ans nal 8 1 8 1 Analogous 1V outlets essere nnne 8 1 8 2 serialinterface RS 232 ite cte iet Hs ei b d dud 8 1 9 TECHNICAL CHARACTERISTICS erect 9 1 9 1 General data 3 nu EPA RR eateries 9 1 9 2 Recording nit i ient nein EM Heer oit 9 1 9 3 ECG SectiOn 2 nere elt m d eem eons ite 9 2 9 4 Operation Section u et guru e bee eei eet eid 9 3 9 5 Standard interfaces uo tu Phe e ep tiis b tege A He e et rio eris a 9 3 9 6 ECG analysis Software s iret sa aul hee ts 9 4 10 CLEANING DISINFECTION Gene 10 1 11 MAINTENANCE CHECKS ein 11 1 12 ENVIRONMENTAL PROTECTION W ASTE REMOVAL 12 1 Annex 1 Unit symbols used Annex 2 Advice on handling thermoreactive recording paper MANUFACTURER S LIABILITY Manufacturer s Liability The manufacturer can only be made liable for possible effects concerning safety reliability and performance of the unit if installation works extensions resettings changes or repair works are executed by persons authorised by the manufacturer the electric installation of the room meets the requirements of the applicable regulations theunit is applied in accordance with this operating manual This unit may only be operated with accessories and other parts supplied from us Otherwise it may come to defects or false information APPLICATION 1 General 1 1 A Application BIOSET 9000E is a 6 12 channel electrocardiograph
25. iltered condition at 10 mm sec Representative Cycles optionally selectable shows the mean value of the normal beats with markings for P beginning P end QRS beginning QRS end and T end 50 mm s unfiltered additional recording of the measured ECG lead II at 10mm sec unfiltered Measurement Results optionally selectable Out of the 12 standard leads it will be put out measured values of QRS range Q R S duration Q R S amplitude ratio of Q R and R S amplitudes as well as the integral of the QRS range measured values of ST T range ST amplitudes positive and negative T amplitudes as well as the integral of the T wave measured values of P range positive and negative amplitudes of P wave as well as the integral of the range Any computer aided evaluation or interpretation must be checked and be given remarks if need be and signed by a physician More detailed explanations about the analysis results and the algorithm of the ECG analysis are given in the HES MWZ ECG manual for the Hanover ECG program Unit SETUP 7 Unit Setup The unit Setup allows customisation according to the user s desire Unit setup means that the unit start with changed parameters All parameters to be selected by function keys marked with can of course be changed during operation Can following parameters can be customised the lead programme made default recording speed of all programmes sensitivity of all progr
26. ime Stop recording by pressing once more If sheet or time control according to chapter 7 is selected recording stops automatically RECORDING IN MANUAL MODE Electrode Faults Every ECG acquisition includes a permanent test of all electrodes In case that electrode fault occur those LEDs start blinking the programmes of which include faulty elec trodes That means in particular If the electrodes R L F or N are faulty LEDs PRI PR5 start blinking If the electrodes C1 C2 and C3 are faulty the LEDs of the programmes with chest wall leads and or NEHB leads i e PRI PR3 and PRS start blinking If the electrodes C4 C5 and C6 are faulty the LEDs of the programmes with chest wall leads i e PR1 and PR3 start blinking The selected programme lights again after the sources of electrode faults were eliminated In case that electrodes drop off in the course of further ECG acquisition the above mentioned fault indica tion will take place Incase that the ECG is recorded despite of indication of electrode faults only those leads the electrodes of which are in proper condition are recorded Intermediate settlement Dropped off electrodes distinct artefacts or insufficient waiting time after electrode application may be the reason of zero line fluctuations during ECG acquisition An jntermediate settlement can be initiated by pressing the same key once more The ECG curve caused by the time constant switched over s
27. n type electrode system consider possible pieces of advice of the instructions Apply the electrodes to the skin areas specially prepared in advance Compared with the resting ECG a modified positioning of the extremity electrodes will be required due to muscle exercises Ergometry Leads acc to Rosenkranz and Drews position further electrodes on the thorax acc to Wilson classic application points in the scapula area change paravertebral SWITCHING THE UNIT ON AND OFF 4 3 Switching the Unit on and off The unit can be energised using either the included rechargeable power pack or the main supply 4 3 1 Mains Operation Connect the mains inlet chapter 3 1 item 8 and the grounded mains socket of the room using the mains cable the charge indicator green LED glows Depending on its charge the power pack is automatically and permanently recharged The unit can be per manently plugged in without damages occurring to it or its power pack Recharging of a completely discharged power pack would take approx 2 h 4 3 2 Battery Operation The mains inlet of the unit is not connected to the mains socket the charge indicator green LED does not glow In case that the battery is to be used not so much battery operation should be selected only when an electrocardiogram must be registered very quickly and a mains socket is not available A completely charged battery provides a minimum of 1 h of 6 channel recording
28. ndustrial waste 12 2 Annex 1 Unit symbols el ECG inlet type CF Ah IMPORTANT see accompanying documents operating manual Xy connection of potential equalisation ex 1V outlet RS RS 232C interface 232C remote start inlet acc 93 42 EEC MDD CE 0123 Notified Body T V Produktservice M nchen Keypad is described in chapter 3 2 Annex 2 Advice on Handling Thermoreactive Recording Paper In order to achieve best recording quality and to fulfil the requirements for long term storage of ECG records make sure that following is guaranteed storage of both fresh paper and records at an ambient temperature of lt 30 C and humidity lt 65 do not expose it to direct sunlight or neon light for longer time preferably store the paper in a dark room avoid longer contact of it with plastics like PVC e g PVC envelops or self adhesive foils for filling we recommend paper envelops do not use glues which contain alcohol or ether do not rub or scratch the paper friction heat will cause colour changes In order to achieve best recording quality and exact paper run we strongly recommend to use only company s von Berg Medizinger te GmbH original recording paper Company von Berg Medizinger te GmbH shall not be held responsible for malfunctions and defects which may arise from the use of recording paper other than from us Malfunctions and defects of this type might be essential deterioration
29. ofthe writing quality improper paperrun contamination or even destruction of the thermoline von Berg Medizinger te GmbH Bahnhofstra e 62 D 08297 Zw nitz 03 77 54 3 13 33 Fax 03 77 54 31301 e mail info von berg medizingeraete de internet www von berg medizingeraete de von Berg Medizinger te GmbH intends to continue developing this unit in order to provide the user with the latest state of technology That is why technical information and illustrations contained herein are subject to change for the purpose of technical development
30. oth patient s and operating personnel s safety are depending 3 Operating Elements 3 1 View Upper Side OPERATING ELEMENTS cover opening button cover of paper chamber keypad ECG inlet EY EY EI BABS Rear side m RS282C e 9 7 Jo 9 7 Jo or 6 7 remote start inlet RS 232C interface 1 V outlet mains cable socket potential equalisation connection NO 00 10 tA PE Sess Ed ci A aa es a as KEYPAD AND KEY FUNKTIONS 3 2 Keypad and Key Funktions Keypad a De S 25 5015 10 20 p oool ooo OJ OJ Ol ENEEEZEEE ABA 6 7 8 9 0 unit on unit off lead programmes QRS sound on off Q speed selector D a sensitivity selector mV test pulse AC filter on off muscle filter on off Automatic recording programme Manual recording proramme START STOP Bl 8 S 3 EE Start analysisorbereitung Enter patient s data i INSERTION OF RECORDING PAPER 4 Putting into Operation 4 1 Insertion of Recording Paper The unit requires thermoreactive recording paper as a block of continuous stationary of 400 sheets with a width of 210mm and a total length of 60 m To ensure good recording quality and proper paper run it is recommended to use only original recording paper it can be ordered from company von Berg Medizinger te GmbH order No 2700 000 021 New recording paper should be loaded when a red marking stri
31. p appears at the lower paper margin If all paper is out recording is stopped and the indicating lamp gt lights Recording paper must be inserted as follows press the cover opening button to release the cover bring the cover into upright position and put it aside insert the paper block into the chamber place properly press it slightly inward and pull some paper out before reinserting the cover nsertthe block in such a manner that the imprint side gets visible if the paper and is pulled to the left The black paper marks must be downside towards the operator reinsert cover bring the recording paper into a symmetric position toward the cover close the cover by slightly pressing its left verge For advice on handling thermoreactive recording paper refer to annex 2 4 2 Application of Electrodes 4 2 1 Resting ECG Connect the delivered patient cable to the inlet marked as ECG INLET ref to p 3 1 and fix it using the two screws Defibrillation protection of unit will only be effective if that patient cable specified in accessories is used The accessories include 4 clamp electrodes for limb leads and 6 chest wall suction electrodes Depending on the patient prepare the application points i e remove hairs and clean with alcohol For ap plication at the chest wall slightly apply electrode gel to the skin areas For the limb electrodes the their clamps should be prepared with electrode g
32. t rhythm can be heard Use key o to start automatic registration The AUTOMATIC programme runs with filter setting speed and sensitivity as selected before starting it After completion of the automatic registration the system returns to that programme which has been se lected before starting it RECORDING WITH ERGOMETRY Recording of both programmes runs time synchronously Time synchronous means that 12 leads are acquired simultaneously and a maximum of 10 seconds of an electrocardiogram are saved Hence programme 2 is registered directly and programme 3 time synchro nous to PR 2 from the memory All settings with regard to speed sensitivity Muscle and AC filter as well as QRS sound are made accord ing to chapter 5 1 Using the key the programme can be cancelled at any time 5 3 Recording with Ergometry Remote Start The remote start facilitates automatic ECG recording on change of load stage The start of recording is induced by the ergometer Recording is made for the currently selected lead program Recording stops automatically when the selected recording time is up The duration of recording can be sheet or time controlled and is made in the Setup chapter 7 Also in the setup the interface is set for the ergometer to be used If one of the ergometers mentioned below is used the control of ECG recording and data exchange by means of the appropriate cable is accomplished through the RS 232 interface p 3 1
33. te GmbH local collecting centres authorised removers NiCd Power Packs Classification batteries waste for recycling being subject to control Exhausted NiCd power packs must not be removed as normal waste They include highly poisonous cad mium and have to be recycled considering the local regulations or to be removed in an environmentally friendly way by manufacturer von Berg Medizinger te GmbH local collecting centres authorised removers Lithium Batteries Classification dry batteries hazardous waste Exhausted lithium batteries must not be removed as normal waste They have to be removed in an environ mentally friendly way by von Berg Medizinger te GmbH local collecting centres authorised removers l2 il ENVIRONMENTAL PROTECT WASTE REMOVAL Timer Modules Classification electronic waste waste for recycling If the customer desires von Berg Medizinger te GmbH takes electronic waste back for removal In case that the customer wants to remove the unit by himself he may obtain a list of authorised German waste removers Accessories Cables Electrodes Patient s Cables Classification electronic waste waste for recycling As far as possible these components are repaired by our service Removal can be accomplished in the same way as of used units Electrode Cream Classification normal waste Depending on local regulations it can be removed through normal waste bins or as i
34. that parts of it may not apply to this unit Used Units Classification electronic waste waste for recycling If the customer desires von Berg Medizinger te GmbH takes used units back for removal Reasonably individual assemblies are regenerated to be used as spare parts All other components separated by types of materials are transferred to authorised enterprises for removal In case that the customer wants to remove the unit by himself he may obtain a list of authorised German waste removers Computers and Components of It Classification electronic waste waste for recycling of waste for recycling being subject to control Computer and components of it boards etc do for power supply often include batteries of power packs which are either replaceable or fixed Since in the course of technical development it happens that suppliers of computer components change from power packs to batteries and vice versa from soldered to replaceable types or change the types to be used the appropriate way of removal may only be selected after having seen the components Also refer to the USED UNITS section NiMH Power Packs Classification batteries waste for recycling Exhausted NiMH power packs must not be removed as normal waste They include nickel II hydroxide classified as hazardous waste and have to be recycled considering the local regulations or to be removed in an environmentally friendly way by von Berg Medizinger
Download Pdf Manuals
Related Search