Home

Manual - PMS (Instruments)

1. pols oduct information u Devices Lead system Lead selection Standard Cabrera Nehb Left precordial Right precordial Right leg General Print Position Right arm Left arm leRfoot o 4th intercostal space at the right sternal margin 4th intercostal space at the left sternal margin 5th rib between C2 and C4 5th intercostal space on the left medioclavicular line Height C4 on the left anterior axillary line Height C4 on the left mesial axillary line AAAs dl OF X umeo j 2 2 Ae ee Message Neuer Anwender 00 38 41 In the Lead selection field select the desired lead system by clicking in the check box in front of the respective designation Standard and Cabrera Lead selection Standard Cabrera gt Nehb gt Left precordial Right precordial Electroden position Electrode o Position __ Right arm bo Left arm Fo Left foot es C1 s amp h intercostal space at the right sternal margin c2 th intercostal space at the left sternal margin c3 Sth rib between C2 and C4 o C4 Sth intercostal space on the left medioclavicular line cS Height C4 on the left anterior axillary line c Height C4 on the left mesial axillary line N Rightleg FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Lead selectio n Standard Cabrer
2. 06 Feb 1919 19 Aug 1981 12 0 Hansen MEME 18 Dec 1940 11 Nov 1988 12 0 Survey Hansen Klaus 18 Dec 1940 10 Aug 1983 12 0 Finding Medi Medset 25 May 1951 02 Dec 2003 15 53 performed Print out Medi Medset 25 May 1951 02 Dec 2003 15 53 performed Tools Medi Medset 25 May 1951 02 Dec 2003 15 54 performed Program settings Medi Medset 25 May 1951 02 Dec 2003 15 55 performed Tools i Medi Medset 25 May 1951 02 Dec 2003 15 57 performed ee Fee EEE A TE Medi Medset 25 May 1951 26 May 1981 12 0 evaluated 4 PAA R RR R R R a 2 e Evaluation Delete Export Import Status GDI export Message Neuer Anwender 01 04 59 Any Rest ECG recording to be evaluated deleted exported or imported can be selected by clicking on it The buttons at the bottom part of the window perform the following actions Evaluation Opens the ECG view directly and where the recording can begin to be evaluated The ECG window can be directly opened for evaluation by double clicking on the ECG recording re quired Delete Individual recordings can be deleted but this does not delete the patient from the database This will however delete the recording irretrievable if it has not been previously exported Export Recordings saved in the PEF file format can be exported Please read the section Patient sheet in the PADSY user s manual Import Files saved in the PEF format can be imported into the list of sa
3. FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 36 Operation Se Survey Navigation tree x uF PADSY Patients 8 6 Examination Holter ECG Long Term BP Rest ECG Recording Evaluation ECG Medset Medi Finding ba tait Dextrocardia type Tools RR 692ms P gi Stress Test ECG P 142ms QRS 93 Tools PQ 164ms T 78 Product information QRS 106ms QT 356ms QTr H 110 Io 100 mm s QTc B 426ms QTc F 402ms I V4 ae H II r III V6 100 mmis II 4 KE I en oe S sells IL al Ales p a N d Xx eO Message Neuer Anwender 00 22 38 Zoom Window In this window the average cycle of the selected lead as well as its measuring points are shown The measurements can be performed with a two dimensional caliper Move the mouse pointer to the position desired as the first measurement point Keeping the left hand mouse button pressed the calipers can be opened Move the mouse to the desired final point The opened calipers can be made larger or smaller by placing the mouse pointer at the final point of a side and moving the mouse while keeping the left hand mouse button pressed The calipers can be moved keeping the left hand mouse button pressed provided you have positioned the mouse pointer on the blue area of the calipers before clicking The respective measured values are shown in gray letters on the upper right The cal
4. D As well as checking the wave point marks a short visual check on the rhythm bar and its main cy cles should also be a permanent feature of quality control during automatic evaluation eo D 3 5 2 Finding NEO sich Medset Medi Navigation tree x PADSY Patients Examination Holter ECG Long Term BP Rest ECG Recording Evaluation ECG Survey Print out Tools Stress Test ECG Tools Product information 180 0 Vertical type 692ms P 80 142ms QRS 89 164ms T 84 104ms 336ms QTr H 104 402ms QTc F 379ms 100 mmis 3 ENN y SSS i Message Neuer Anwender jo00 39 26 This window allows the findings to be compiled To enter the medical data click on the light blue Finding window Its color will turn dark blue and the findings can be edited using the keyboard The data entered is included directly in the printout To avoid having to spend the time to type commonly used passages of text repeatedly it is possible to insert text templates To get more information about the creation of text templates please see the user s manual for PADSY The Patient Diagnostic System The button HES finding is inactive in this view This function is a software option of the Auto matic interpretation The other 3 windows are identical to the Measurement window 3 5 3 Automatic Interpretation Software Option In contrast to the Finding without Automatic Int
5. Sys p mmHg Dia pn mmHg nox ji Cancel In order to enter recording data press the following button or use the keyboard shortcut lt M gt The following window will appear in which a note about the patient s comments during the recording can be saved ye Recording data x Comment Avon Confirm the entry by clicking on the Accept button Clicking the Cancel button will close the window without saving the comment The channels are reset using Deblock Deblock The channels are also automatically reset after the electrodes are re attached however this automat ic control can be considerably accelerated by resetting the sensor with the Deblock button The selected recording time and the state of examination progress are also shown FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 30 Operation _ 80 seconds ci In order to save the ECG recording left click on the following button Alternatively the lt Space bar gt on the keyboard will also actuate the saving process FLASHLIGHT PADSY has a ring memory at its disposal allowing the ECG data to be continuously saved over the set period When the save button is actuated the last 10 20 30 60 or 180 seconds from the ring memory are permanently stored If at least one ECG channel over modulates or the serial data flow is interrupted this time period is marked across all ECG channels with a grey background Nothing shou
6. Q amplitude pV 180 200 350 Table 96 quantile of Q amplitude and Q time in normal groups When these limits are exceeded there is a high probability that an abnormal situation exists for this criterion It is important to note however that there can be individual cases 4 in which a nor mal ECG can take on these values Further information is given to describe bundle branch blocks in cluding information on a second R wave in the QRS complex M form etc With this information however the limit values are set so high that they are exceeded only in the relevant blocks References to the P wave 1 Atrial lead interference PD gt 126ms 2 Abnormal P vector Angle lt 30 or Angle gt 90 3 P Sinistro atrial 4 P Dextro atrial 5 P Bi atrial For this reference the P amplitudes gt 250uV the predominance of the first or second peak and the Morris index are checked and a score produced from this check References criteria and threshold values for the QRS complex e Widened QRS This reference appears when the QRS time exceeds 115 ms in a man and 105 ms in a woman e M Form in An M form is present when two R waves exist in a lead which have an amplitude of at least 300 pV e Qin No reference is made to a Q wave for the AVR lead because of its negative polarity For the other leads a reference to Q waves occurs when the amplitude and Q time are above the 96 quantile from NORMAL See table 96 quantile
7. type Grade 3 Isoelectric ST deflection with transition into terminal negative T wave of less than 0 5 mV Compat ible with later stage slight re polarization disturbances of the outer layer type Grade 4 Isoelectric ST deflection with transition into terminal negative T wave of more than 0 5 mV Compat ible with later stage severe re polarization disturbances of the outer layer type FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Appendix Page 57 8 3 EC Declaration of Conformity EC Declaration of Conformity Document No Month Year QKE 13 00 002 04 02 05 Manufacturer Medset Medizintechnik GmbH Curslacker Neuer Deich 66 D 21029 Hamburg Germany We hereby declare that the product FLASHLIGHT PC ECG System consisting of FLASHLIGHT SENSOR type SE USB with FLASHLIGHT PADSY ECG amplifier module Rest ECG Software from version A for version 3 5a and higher in the following models ECO SCOPE and FLASHLIGHT ERGO PADSY Stress Test ECG Software from version 1 0a in folgenden Ausf hrungen E T ER TR with the following accessories FLASHLIGHT patient cable 10 leads complies with European Directive 93 42 EEC of the Council of 14th June 1993 concerning medical products It bears the mark C 0124 Hamburg 28th February 2005 Medset Medizintechnik GmbH Legally binding signature Klaus Kophstahl Managing Director The technical documentation is kept in quality department
8. FLASHLIGHT Rest ECG application can only be started under PADSY Perform the following steps 1 Start PADSY as described in the PADSY The Patient Diagnostic System user s manual 2 Select the navigation tree Examination and then Rest ECG Patients Examination Holter ECG Long Term BP Recording Evaluation Tools L Program settii Tools L Product information The following screen appears p gt Rest ECG Nav gation tree ole x Patients Examination Holter ECG Long Term BP Rest ECG Recording evaluation Tools L Program setti Tools Product information medset MEDIZINTECHNIK From this screen the Recording window may be opened by clicking on Prepare Rest ECG record ing or the Evaluation window may be opened by clicking on List of all Rest ECG recordings FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 16 System Elements and Components 2 8 Configuration of Rest ECG settings Once the software has been installed please continue with the configuration of the settings Rest ECG settings Select the Program settings bullet in the navigation tree from the Rest ECG Tools window The following window appears in the Devices register N Program settings Navigation tree x gt Devices Eia SY atients amination Long Term BP Here you can select the devices you need for Rest ECG recording To be able to carry out Rest ECG recording you must Rest
9. S amplitude in I Q amplitude in III e Left anterior hemiblock Q amplitude in I Initial QRS frontal angle Maximum QRS frontal angle S in II and III simultaneous and S amplitude in II S in II and III simultaneous and S amplitude in III Q amplitude in AVR S amplitude in AVR QRS start to ENB in AVL S amplitude in V5 S amplitude in V6 e Trifascicular block Possible and certain incomplete RSB Possible left anterior and left posterior hemiblock Possible and certain incomplete LSB PQ interval gt 200 AV block e Left bundle branch block QRS start to ENB in I QRS start to ENB in AVL QRS start to ENB in V5 QRS start to ENB in V6 Pre excitation syndrome Every lead is checked for 4 waves or slow QRS rise and appropriate information given A reference is however made to pre excitation syndrome only if the PQ segment interval P end QRS start is shorter than 30 ms FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 56 Appendix there is no atrial fibrillation flutter present because then no PQ can be defined there is no anterior myocardial infarction present Information on re polarization disturbance In principle the re polarization phases are checked in all leads Special information however is only provided for the leads I AVL and V3 V6 Inner layer and outer layer damage are distin guished according to different degrees of intensity Inner layer damage Grade 1 Flattened T
10. Safety This user s manual forms an integral part of the FLASHLIGHT Rest ECG system and must therefore be kept in the vicinity of the product at all times Precise compliance with the user s manual is an essen tial condition for normal use correct application and thus safety of patients and users The FLASHLIGHT Rest ECG system must only be used by personnel who due to their training know ledge and practical experience are inclined to use the system correctly eo D FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Application and Function Page 9 The FLASHLIGHT Rest ECG system user s manual must be kept in the vicinity of the system at all times for reference purposes They are an integral part of the system Precise compliance with the user s manual is an essential condition for correct application use and guarantees the safety of patients and users eo D The FLASHLIGHT Rest ECG system is a type BF appliance with increased voltage spike protection It is not intended for direct application to the heart eo D When a defibrillator is used on the patient all safety precautions for defibrillator use should be complied with D The FLASHLIGHT sensor module is a type BF defibrillation protected applied unit eo D All parts of the system particularly electrodes and leads may only be applied to healthy skin on a patient eo D Please note that the conductive sections of the electrode cabl
11. Z gt button or to the the left the with lt Ctrl gt and lt Z gt buttons The calipers can be closed by pressing ix Information and operating field The Channels field enables selection of the number of channels shown By activating the appropri ate buttons 3 6 or 12 channels can be selected to be displayed By clicking on the arrow keys the leads to be shown on the monitor can be selected u Channels The respective filter can be turned on or off by clicking on the check box in the Filter field Filter l Dnft et Muscle Power If the patients blood pressure has not yet been measured for the examination the blood pressure value can be entered using the following button W In order to enter recording data click on the following button The following window will appear in which a note about the patient s comments during the recording can be saved Sf Recording data x Comment Confirm the entry by clicking on the Accept button Clicking the Cancel button will close the window without saving the comment FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 35 In the lower part of the information and operating field there is a navigation field with the following functions which can be activated using the left mouse button By activating the arrow keys the current ECG recording page can be moved forwards AF and backwards Sprint Window The sprint window is
12. be switched on or off by clicking on the check box control box in the field Filter Filter e Dintt Muscle lJ Power The antidrift or baseline filter serves to equalize fluctuations in the ECG signal around the baseline The 35 Hz muscle filter suppresses muscle artefacts The 50 and 60 Hz supply filter compensates for noise which is generated by the PC power supply The electrode display in the software has an electrode recognition function with the following color coded meanings 9 red The electrode is not correctly attached If the electrode is correctly positioned and the display is nev ertheless still red the electrode should be re attach after repeating the skin preparation procedure green The electrode is properly attached The following window appears by clicking on the electrode display FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 29 Electrode status X The Electrode status window shows electrodes that are not correctly applied and specifies the pos itions where the electrodes are to be attached properly In order to initiate a blood pressure measurement press the following button Keyboard shortcut lt Enter gt For manual blood pressure monitoring an interactive dialogue box is available to enter the systolic and diastolic blood pressure values by Manual blood pressure measurement X Please note the values measured
13. located below the ECG signal window Rig ER gSRL See ee a 158648 Yop yy Cy ee 15 56 14 165627 ee se eee In this view an overview of up to 3 minutes per page of the ECG can be seen The control pointers make it possible to scroll within in the sprint window The individual symbols have the following functions Scroll backwards line by line Scroll forwards page by page Scroll forwards line by line Scroll backwards page by page Clicking the right hand mouse button allows the settings for the sprint window to be configured a 25 O K Fo Yo G 100 o ETE Ya Amplitude Speed Lead The signal amplitude can be changed from 25 150 by clicking on the desired value under Am plitude In the Speed menu the time shown per page can be chosen 10 seconds 3 minutes Under Leads the ECG leads to be shown in the sprint window can be selected Measurement is made using the HES program integrated in PADSY The Hannover ECG program sys tem for computer assisted evaluation of electrocardiograms The representative cycles also called average value cycles of the normal ECG complexes are auto matically created with their characteristics by the program A typical ECG complex for the patient being examined will thus be shown The Survey view is allocated in the following windows Zoom Window Measurement Window Single Complex Selection Rhythm Strip ST Overview and Histogram
14. outlet eo D Mechanical stresses on supply cables can be further reduced by coiling them loosely and prefer ably hanging them up eo D If a non stationary multiple socket power bar is used connection of equipment may only be possible with the help of tools or the non stationary multiple socket power bar has to be supplied by an isolating transformer The norm DIN EN 60601 1 1 should be observed eo D If the system is connected via an isolating transformer all other parts of the system must also be operated via this transformer otherwise the electrical isolation will be ineffective eo D FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 12 System Elements and Components 2 System Elements and Components 2 1 PC with peripherals lt lt mE PC with monitor keyboard and mouse E 7 aN STOTT a D k AAMAS AAA AAAA A A 2 2 Z A Printer 2 2 Sensor with PC interface cable FLASHLIGHT ECG TRANSFER POWER 1 Rest ECG sensor FLASHLIGHT SENSOR Type SE or Type USB FLASHLIGHT Rest ECG System for PADSY from Version 3 5b System Elements and Components Page 13 2 Socket for patient cable There is a Sub D socket at the top of the unit for connecting a 10 pole patient cable with a Sub D plug 3 ECG transfer indicator ECG TRANSFER The red LED lights up when ECG data is transferred via the PC interface cable 5 4 Status indic
15. strip can be seen beside their representative cycles FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 43 Sp Measurement Medset Medi Navigation tree x DSY Patients Examination HF bpm Patient Meviset Medi Recording frome 02 Dec 2003 15 55 31 Practise Clinic Medset Medizantecarik GmbH Carsten Florian Date of birth 25 May 1951 52 Years Blood pressure mmHg Street Curslacher Never Deich 66 Holter ECG Patient ZIP Town 21029 Hamburg 86 Sex Size Weight female cm bg Recorder Neuer Anwender Pacemaker Nein Finder Long Term BP Rest ECG Finding RS RS Evaluation Snr theme a ee wa FECG 1 Hb tL va thy Peros erse Pa l me Me 279 m hohes Rin III ORS 104 ms Olr 104 Survey britesSin I ee EEB E EOR ps tiefesSin AYL Y3 4 W5 6 Finding i gt ST Senkung in II III AVF pa unspezifische ST Seqment Yeranderungenin 4 YS Y6 Q Print out t f P sinistm atnale wahrscheinlich ECG Il v2 ey ORS T BEWERTUNG z i i echtsventrikul e Hyperto phie HN e easurement GESAMIBEURTETLUNG Tools eer gee QRS RS abnormates EKG NIY Stress Test ECG Ill v3 Ss Tools Feeders RHR l i Wer tical Product information ER Se RSR RS P 80 T 84 QRS 89 aVR staat BABE En V4 Duration ms max amplitude mV mV s a R S Poon Prog a R 5 Tron Treg J ST sT t t f t f t I 42 58 0 05 0 27 041 0 04 0 01 RS
16. 04 Demo Rest Sinusarrhy n 06 May 1938 1 13 Apr 20 13 Apr 2004 Tools Demo Rest VHF Hypertro 13 Feb 1925 1 13 Apr 20 13 Apr 2004 Program settil Tools Product information X lt ra E Start New patient Delete Message Neuer Anwender 01 08 52 All patients existing in the PADSY patient diagnostic system are shown in the patient list The fol lowing information is displayed for each patient first name surname last change last examiner the number of recordings which have already been made of the patient GDT ID Identification and date of birth The Table configuration window may be displayed by pressing the lt F10 gt key or via the right mouse button menu The settings for the patient list can be configured in this menu Start the recording of a Rest ECG by first selecting a patient from the list with a double click Alterna tively a single click on the patient record followed by clicking on the Start button in the lower part of the window will start the recording To find patients more quickly the patient list can be filtered and sorted as described in the PADSY The Patient Diagnostic System user s manual A patient can be deleted from the list simply by marking the record with a click and then clicking on the Delete button To include a new patient on the list click the button New patient The following window appears In the New Patient view the data for a patient not yet listed in P
17. 4 V5 and V6 Einthoven Goldberger and Wilson V1 V2 V3 V7 V8 and V9 Einthoven Goldberger and Wilson VR5 VR4 VR3 V4 V5 V6 optionally via electrode C1 C2 or C3 Lower limit 1 Hz no upper limit Averaging over 4 beats from all channels Notch filter with a frequency of either 50 or 60 Hz for the suppres sion of power line hum Low pass filter with a cut off frequency of 35 Hz to suppress mus cle artifacts High pass filter with a cut off frequency of 1 Hz to suppress fluctu ations in polarization at the electrodes FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Accessories and Consumables Page 49 7 Accessories and Consumables 7 1 Accessories Order Code Article Designation FLASHLIGHT set of accessories Delivery schedule 1 patient cable 10 lead with 4mm banana plug FL ZU 4 extremity clip electrodes 6 chest wall suction electrodes 1 250 ml bottle of electrode cream FLASHLIGHT patient cable eee 10 lead with 4 mm banana plug FLASHLIGHT patient cable ee 10 lead with clip adapters FLASHLIGHT patient cable 10 lead with push button connection Set of chest wall suction electrodes FLZ BWS Delivery schedule 6 electrodes with banana Cl sensor Set of extremity clip electrodes FLZ KO Delivery schedule 4 electrodes with banana Type KO 9F C Ag AgCl sensor a ooo FLZ GPSE please state version when ordering 7 2 Consumables Order Code ARBO disposable electrodes CVE H92 with pushbutton conne
18. ADSY may be entered To do this click on the required field The fields can be changed with the key combination lt l gt or lt Ctrl gt lt gt to select the next field or lt t gt lt l gt to select the previous field or using a mouse click FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 27 Sy New patient Identification a Name First name Sex unknown Date of birth Street Height cm Address Weight poo kg Pacemaker m Doo start orreee For clear identification of the patient a minimum of Name and First name along with Date Of Birth in the format DD MM YYYY or DD MM YY must be entered in the appropriate fields Field assignment i e patient identification number address with road street and place name pacemaker i e whether the patient is fitted with a pacemaker or not sex height in cm weight in kg and comments e g on the patient s case history must be entered as necessary In the appropriate field on the right there is a pull down menu available for selecting standard en tries for the Pacemaker and Sex data When the Sex field is highlighted the keyboard can be used to select lt M gt or lt F gt After entering the data in the patient sheet confirm the input with the Start button In doing so the Start Window will be loaded directly Click the Cancel button to exit the window without making any changes 3 4 1 Start The rec
19. DIN EN 60601 1 and DIN EN 60601 1 1 Connection of the FLASHLIGHT SENSOR The Type SE sensor should be connected to the PC as follows The Rest ECG sensor FLASHLIGHT SENSOR Type SE may only be installed with the PC switched off 1 Remove the keyboard connection plug Now plug in the Rest ECG sensor power supply by inserting the plug of the PS 2 adapter into the keyboard socket of the PC If necessary use the adapter components for the connection 3 Insert the keyboard plug into the socket of the PS 2 adapter Connect the 9 pole plug of the PC interface cable to a vacant serial interface COM port on the PC ECG data is transferred to the PC via this connection and can be displayed with the FLASHLIGHT ECO and SCOPE software 5 Connect the patient cable to the Sub D socket of the FLASHLIGHT sensor located at the top of the equipment The Type USB sensor may be connected as follows Connect the USB plug to a vacant USB port on the computer If the Type USB drivers have not been installed yet the new hardware found message will be displayed Clicking on this message opens the New Hardware assistant that will perform the driver installation Follow the assistants instruc tions The required drivers are found in the installation CD in the Windows Flashlight Sensor USB directory The Type SE and Type USB FLASHLIGHT SENSOR Rest ECG sensors have integral defibrillation protec tion The patient cable therefore does not need to be provide
20. ECG can be de fined A recording time of 10 20 30 60 and 180 seconds can be selected by clicking on the appropriate check boxes Furthermore it can be selected whether or not to switch directly into evaluation after the Rest ECG has been recorded For this purpose select on or off by clicking the respective but ton Filter settings to be used for the evaluation analysis and recording can be defined The antidrift or baseline filter serves to equalize fluctuations in the ECG signal around the baseline The 35 Hz muscle filter suppresses muscle artefacts The 50 and 60 Hz supply filter compensates for noise that is gener ated by the PC power supply Likewise select the frequency for the supply filter of 50 or 60 Hz by clicking on the respective but tons Settings for pacemaker recognition may also be defined in this view Select whether no recognition should be made or whether C1 C2 or C3 should be recognized by clicking on the appropriate buttons Print The following display appears FLASHLIGHT Rest ECG System for PADSY from Version 3 5b System Elements and Components Page 21 gp Y Program settings PEMA Devices Lead system General Prt SY atients amination Holter ECG Long Term BP Rest ECG Recording Evaluation Tools Program settings pols i oduct information Selection iG GS Measurement 4 m Ess D Xx lt o EE ee eee 7 Message Neuer Anwender 00 54 32 In this view the pri
21. ECG select an amplifier and a sphygmomanometer Recordin g Note If you cannot select any devices here you have presumably not yet installed any devices To install devices please Evaluation use the device manager under the PADSY tools Tools Program settings z gi ECG sensor amp gt FLASHLIGHT Sensor Typ SE Stress Test ECG ie Sphygmomanometer Manual sphygmomanometer Holter ECG oduct information Raneral Pont eal General l CORE SSD x Message New user 00 38 54 4 This window allows the equipment required for recording the Rest ECG to be selected It is necessary to select an sensor and a blood pressure monitoring device A drop down menu is available for the ECG sensor and the blood pressure monitoring device from which already installed devices can be selected If no equipment appears in this menu then no equipment has been installed In order to install equipment use the device manager under PADSY tools which is the second to the last bullet in the PADSY navigation tree Follow the instructions in the PADSY The Patient Diagnostic System user s manual 2 8 1 Lead system The following window is displayed FLASHLIGHT Rest ECG System for PADSY from Version 3 5b System Elements and Components Page 17 Sg Program settings Navigation tree SY atients amination Holter ECG Long Term BP Rest ECG Recording Evaluation Tools Program settings
22. FLASHLIGHT Rest ECG System for PADSY from Version 3 5b
23. INSTRUCTIONS FOR USE i EN English FLASHLIGHT Rest ECG System for PADSY from Version 3 5b CE 0124 LU medset ee MEDIZINTECHNIK We have sound ideas PADSY General Information Note D This user s manual contains essential safety information in addition to information on the oper ation care and maintenance of your FLASHLIGHT Rest ECG system for PADSY The safety inform ation must be read and fully understood before installation and start up Only in this manner will the safety of patients and staff be guaranteed This user s manual must always be kept with the equipment and accessible to all users All rights particularly translation rights to the text and illustrations are reserved All manner of re production is permitted only with the approval of Medset Medizintechnik GmbH All and any reprint ing including extracts and all and any reproduction of the illustrations including in a modified state are prohibited Due to continual development equipment specifications and graphics are subject to change without notice The following pictograms are used Safety notes non compliance with which represents a danger to patients operators or the equip ment and visually emphasized by the adjacent graphic symbol Attention Refer to the User s Manual Defibrillation protected applied part type BF General Information GBA 13 00 002 06 Instructions for Use FLASHLIGHT Rest ECG syst
24. MmponentS sessessesoececsecoecoecsecoecoecocsocsecoecoecsecoecoesoesocsecsecsessesse Le 241 PC with peripherals sessscscevscscasscecsscevecndasiecsesedscassnaceetstwacees ues aeaa a ara a asiaa aaa 12 2 2 Sensor With PC interface Cad les siscasecescecscadsiescseccscacesweveaesescdoussssasececdesesesiceeeedececsssucsccesins 12 2 3 Bringing EQUIPMENT into USC iiss ccicsascccacescteseisedesecscesetassesaseeceesesaceseseecensodesssusecessevasessenede 13 2 4 Connection of the FLASHLIGHT SENSOR sssccccccsscccccscccecssescscsceseceesescscevesccessessesevesecesssstceese 14 2 5 Installation of the FLASHLIGHT Rest ECG Softwar e sccccccsscsccssscccccsscscccsscsccccscscscsees 14 2 0 Hardware INSCALLALION wiswceseese cescvonadedsocssluocedssusceusvenecdeiss ccsedesgensdvedevedsnusceessussevetecwenccdsveus 14 2 7 Starting FLASHLIGHT Rest EC Gucscssicccssiccescccececdshecesvesecwsetscseseeceewcovecsosed covetosessuecsesssenstesses 15 2 6 Contiguration Of Rest ECG Settings cccsscceccscesdscscdeecssccoecessceesesssscesccouseseddscesseoedsessoccesecsess 16 28s ECAC Syste Me a a a cl sesaeeedeeasdeul soewadeane vauduaeecsad teeeeconemeseudselates 16 CEO ue OIC Mall wag atccceen see a catateoadeuawanm cae acuebnas seater stom seaceeeauonaus 19 SB OU CRALION soxccuderstecusais AE N E ENN ELS Bed Generaler ieai a a aat 23 3 2 Window SED AlALON cescscscccises cousins bases sctccnsecsusussevexstecesdssccesxeevodssexcessaeededeasacensseteacesseceesssuss 23 Bed SOUUI
25. NGSccccseciseudecsscesuessocsvacsecsecisoccueeceasessecedesecocsuocecccusosessussedeauseesses sveasduscesstecedssaseseseaes 23 3 4 Recording a Rest ECGs seseecssccatscveceseccevisestetcvsstvawscesestesseesdoecoesvenceutveneuadetateoouscseesiescevaseves 26 o NA de SU 1 a EE E EE A A EAN E E O E O AE I A E EE T A ten aes 27 3 4 2 Recording an emergency EU Gates aiecsecascecescinccudabuwesocadunsasne Ea 30 3 5 EVAL AUT OMe oree oaae EE EENEN EAEE EONA EE TEE E A ETES 31 Oe EC G iura E a a a a aes 33 PL PINGING eai E E A 38 3 5 3 Automatic Interpretation Software Option ssssssssssososossssssesesesesescsosososososossssss 38 FOA POU ei a o a E E N deenenusaseleact 40 A Cleaning and MaintenanCenccesccscictesccsccsssicudicecatascaacsieetscaeniseeddiceieveacessliseiscasdesaveseieadene OD 4 1 ECG SENSOR MOGUIC ss sesecdstesevesieeds cs viseccecescecsccevessvaentetuaenesseeseeviesuvessesesvasesdsccsussoveseseseceese 45 4 2 Electrode and interface CADIS sissecessccecsssesscedecees cs dene ceseuneses susecendusveds seceetsues sess vcsvededessecees 45 ZZ PMN e CE cctutccsceeseesnue sic eu wate tue cee E a a nates maaeeeutans 45 5 Function Testing and Troubleshooting ccccccccccccccccccscsscsccscsccscscscscscscscccccscccccccscscecs 40 S1 FUNGCHION testare rears n nA E E 46 Delo FeOStING the sensor connectoren ie a a NN 46 512 Testing therecord TUNC ON srera snaa ia A RTE N 46 Sedea AOSTA ENa CODY arrana A E RAR 46 5 2 Troubleshooting ss ccoccesecerce
26. RS n 22 42 40 0 26 0 17 1 72 0 24 0 06 0 12 vi EN ys RENEE m 28 40 36 0 21 0 20 1 76 0 05 0 04 0 13 p i avr 44 40 0 15 0 24 0 94 0 04 0 05 avi 30 74 0 08 0 12 0 98 0 07 av 24 42 38 0 23 0 18 1 71 0 14 0 04 0 12 vi 32 72 0 09 0 14 40 73 0 03 0 06 al ORS ear Fees ORS v2 34 70 0 08 0 28 1 02 0 06 v3 42 62 0 08 1 08 2 67 0 15 0 09 avF v6 v 50 54 0 14 1 56 2 12 0 11 0 02 v5 52 52 0 14 1 76 1 12 0 02 0 10 0 04 v 14 36 48 0 12 0 06 1 22 040 0 03 0 05 30 mm s 3mm m 30 mm s Smm m I 23mm s Smm m FLASHLIGHT 3 00 PADGY 5 ta 12 Kana KG Verse Madset Ned izin tach nik GH Automatic HES analysis Paceraber detection ci Pago of Message Neuer Anwender 00 40 40 The complex detected for each lead is shown in the display of representative cycles The measured values above or under the Cabrera circle are marked with an asterisk if the limits are ex ceeded If the measuring points are changed in the Zoom Window of the Measurement the HES value ta ble display is extinguished and the Automatic HES analysis label in the base line of the printout changed to Manually Edited The table of values with the original HES values can be superimposed again using the upper settings bar The Manually Edited label also appears after editing of the finding in the Automatic Interpreta tion software option Short explanations on the individual measurements are given in the Appendix under
27. Representative Cycles and Intervals The following window appears after recalling the print settings Settings for Measurement Ea Speed Complex Table Lead system O CO Yes Standard w 50 mm s w No o Gyl Amplitude Complex Amplitude Strip DI Ove 3 20 mm m 2 20 mm mv O IH COG 10 mm m 2 10 mm m ao oe 2 afl 5 5 mm mif w 5 mm mi Ci aF 2 V6 2 mm ni C2 mm m FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 44 Operation The settings for the feed and the amplitude for the representative cycles can be specified in this win dow Additionally the table with the measurement values can be faded in and out Similarly a drop down menu is available for selecting the lead systems The amplitude and the leads of the rhythm strip may also be chosen FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Cleaning and Maintenance Page 45 4 Cleaning and Maintenance 4 1 ECG sensor module The ECG sensor module can be cleaned with a damp cloth with a mild household detergent and any standard hospital detergents and disinfectants containing alcohol lt 70 Abrasive substances and disinfectants with a phenol base and peroxide compounds are not suitable for surface disinfection and cleaning Please pay attention to the information written in the instruc tions included in the detergent and disinfectant packaging eo D During cleaning and disinfecting ensure that no liquids enter the ele
28. S complex Notes on ventricular stimulus disturbance and Notes on repolarization disturbance QRS T evaluation In this section the ECG is assigned to the groups Normal Right ventricular hypertrophy Left ventricular hypertrophy Biventricular hypertrophy Anterior myocardial infarction Infarc tion as well as any combination of infarction and left ventricular hypertrophy Interpretation of the representative ECG cycle is made using complex logic and statistical decision functions This involves checking the ECG recorded for Similarity to normal and pathological elec trocardiograms To accomplish this the isolated Q waves or large R S intervals in addition to a large number of parameters from the depolarization and repolarization phases are evaluated Overall assessment Here the program produces an overall assessment from the rhythm obtained the information on find ings and the QRS T evaluation e g normal ECG Further information can be found in the Appendix under Automatic Interpretation Please note that every Automatic Interpretation must be checked by a physician and will only be recorded as the medical finding after manual entry of the evaluated status eo D 3 5 4 Print out Selecting the Print out view from the navigation tree causes the following window to appear F r Sp V Print out Astrid Muhrmann Navigation tree x f PADSY Patients Examination Re
29. V3 to V6 Table 05 represents the minimum S time in ms which when exceeded produces this information FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 54 Appendix R time ms Minimum S time for message Wide S Low S in If the 96 quantile in normal groups is exceeded the following information appears automatically 480 480 950 1500 900 500 96 quantile of the S amplitude in normal groups Information on ventricular stimulus disturbances bundle branch blocks Every ECG is investigated for ventricular stimulus disturbances during ventricular depolarization The primary criterion for a reference to a delayed conduction is the QRS complex not necessarily a R R configuration e g in AVR or V1 V2 if the QRS complex is not simultaneously extended The previ ously published criteria are neither uniformly nor quantitatively defined accurately enough for a com puter evaluation Therefore in the HES program several at least four criteria measured variables are therefore checked for each type of block and a score determined according to intensity Then depending on the score value a reference is made to incomplete complete bundle branch block hemiblock or in mixed symptoms to intraventricular stimulus disturbances The possible bundle branch block data of the HEW program with the variables tested are listed below In addition the QRS complex is measured as an additional criterio
30. a o Nato gt Left precordial Right precordial Left precordial Lead selection gt Standard O Cabrera C Nehb Left precordia Right precordial Page 18 System Elements and Components Electroden positio n Electrode ae ae a a a r T On un Bs aaa ma ee Position Right arm Left arm Left foot 2nd intercostal space at the right sternal margin Sth intercostal space at the left posterior axillary line 5th rib between left sternal margin and left medioclavicular line 5th intercostal space on the left medioclavicular line Height C4 on the left anterior axillary line Height C4 on the left mesial axillary line Right leg Electroden position Electrode 2 CajyCajec aye a E E Oy Um Bs lag Po ee Position Right arm Lett arm Left foot 4th intercostal space at the right sternal margin 4th intercostal space at the left sternal margin Sth rib between left sternal margin and left medioclavicular line 6th Rib on the left hinteren axillary line Height C5 on the scapular linie shoulder blade line Height C5 on the paravertebral line line at the side of the vertebral co Right leg FLASHLIGHT Rest ECG System for PADSY from Version 3 5b System Elements and Components Page 19 Right precordial Lead sel le ctio n gt Standard C Cabrera O Nehb gt Left precordial Right precordia User defined Position Right arm Left arm Left foot Sth intercosta
31. ads down lt Page down gt The respective filter can be switched on or off by clicking on the check box in the field Filter Filter je Dnitt e Muscle ll Power The feed rate of the signals to be shown on the monitor can be selected in the Feed field Feed 100 mm s 50 mm s 25 mm s 12 5 mm s FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 25 In the Amplitude field the amplitude of the signals shown on the monitor can be set Amplitude 25 mm mv O 20 mm m 15 mm mv O 10 mm mv 5 mm mV O 2 mm mv Confirm the choice by clicking on the Save button These settings will be saved when exiting PADSY e Raster adjustment In the ECG settings window under the Raster tab adjustments to the grid can be made The following window appears Recalibration This setting only needs to be performed once and does not have to be reset every time PADSY is star ted The grid can be expanded or compressed by moving the arrows next to the grid horizontally or vertically The grid adjustment serves to set the grid exactly to 1 cm x 1cm In order to make the adjustment please use a ruler as a guide The new setting of the grid adjustment is shown immediately by click ing on Recalibration button Settings in the ECG signal window There are also a wide range of adjustment capabilities in the ECG signal window of the Rest ECG sys tem Shifting ECG channel
32. anged via the 1mV calibrating peak and the ECG channel can be moved vertically using the ECG channel designation Measurement Window The measurement window contains the Cabrera circle showing the vector diagram of the ECG the au tomatically assigned position type and all measured values Explanations relating to the individual measurements can be found in the Appendix under Represen tative Cycles and Intervals 405 Vertical type RR 692ms F BO Er 142ms ORS 8gs P l ms T 84e QRS 104ms OT 336ms QTr H 104 QTc B 402ms QTc F 379ms Single Complex Selection In the Single complex selection window all averaged QRS complexes for the individual leads can be viewed Clicking on a QRS complex will cause it to appear in the zoom window The settings can be edited in the Single complex selection using the right mouse button The amplitude and the feed for individual complexes can be selected here Rhythm bar FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 38 Operation The rhythm bar shows the last 10 seconds of the ECG bar for the selected channel in which cycles which may be evaluated are shown in black and cycles which may not be evaluated are shown in gray The amplitude can be changed using the amplitude setting in the selection window The last 10 seconds of the ECG are used for measurement in the HES analysis There must be at least 3 cycles capable of evaluation eo
33. ation POWER The green LED lights up when the Rest ECG sensor is supplied with power from the PS 2 ad apter 7 5 PC interface cable The PC interface cable is used to transfer ECG data to the PC and is hard wired to the sensor 6 PC interface cable plug Type SE The 9 pole plug connects to a RS232 interface COM 1 to 4 on the PC Type USB The USB plug connects to a USP port The sensor is then powered by the USB port Components 7 8 and 9 are not present on the Type USB sensor 7 PS 2 adapter Type SE The FLASHLIGHT sensor is supplied with power from the PS 2 adapter 8 PS 2 plug Type SE The PS2 plug of the adapter 7 is connected to the PS 2 socket keyboard connection of the PC 9 PS 2 socket Type SE The PS 2 plug of the keyboard is inserted into the PS 2 socket of the adapter 7 2 3 Bringing Equipment into use eo D PC monitor and printer required for the FLASHLIGHT PADSY application are classified as office equipment under IEC 950 The regulations contained in IEC 950 manufacturing requirements for of fice equipment do not meet the higher safety requirements for electromedical equipment To ensure safe operation of equipment that draws its power from the building supply a ground fault detection and disconnect system has been incorporated into the ECG sensor module because accord ing to IEC 950 a ground leakage current and a chassis leakage current in the event of an initial fault of gt 0 5 mA is permi
34. ction and foam plastic support Type H92LZ AgCl sensor FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 50 Appendix 8 Appendix 8 1 Measurement 8 1 1 Representative cycles To produce the representative cycles the individual ECG complexes are first extracted from the recor ded ECG A complex is then analyzed to determine which of the recorded ECG cycles is suitable for producing an average Representative Cycle The following must be determined e Which cycles have the same QRS T morphology e Which cycles have the same P morphology e Which cycles are extrasystoles and which correspond to a normal beat e Which cycles are unsuitable for the evaluation due to excessive base line fluctuations or other disturbances e Which RR intervals are between the cycles e This ensures that no ECG cycles are evaluated which do not actually have the same mor phology e All cycles are shown in relation to one another in the Evaluation gt Measurement window under the various cycles A section shown in gray here at the beginning shows that this has not been included in the algorithm e The following criteria lead to the exclusion of individual cycles from the representative cycle e Base line fluctuations e Interference e g hum e Interval to the previous and or subsequent beat too short e Deviation from the main type in the QRS morphology e Deviation from the main type because of deviatin
35. ctrode through its apertures 4 2 Electrode and interface cables Cleaning Connectors patient cables and connecting cables can be cleaned with lukewarm soapy water or a neutral detergent Disinfection All hospital standard disinfectants free of phenol and peroxide compounds containing alcohol up to 70 can be used for disinfection Leads must not be autoclaved since this could damage the insulation Leads with damaged insulation are extremely dangerous for all persons who knowingly or unknow ingly come into contact with them Defective leads also endanger the electronic circuitry of the connected electrode D Leads with damaged insulation cannot be used for further operation of the electrical electrode Plug and socket connections must always be kept well away from live sources of electricity D Never immerse cables or connectors in liquids Protect cables against strong UV radiation 4 2 1 Maintenance The FLASHLIGHT Rest ECG system does not require regular calibration or safety checks However immediate repair work will be necessary if e the electrode has been subjected to extreme mechanical stress e liquid enters the electrode eo D e cables case and or connectors suffer damage or e covers are missing FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 46 Function Testing and Troubleshooting 5 Function Testing and Troubleshooting This chapter describes a complete test
36. d with additional defibrillation protec tion Installation of the FLASHLIGHT Rest ECG Software The PC ECG software is an application of the PADSY Patient Diagnostic System For this reason carry out the installation according to the PADSY The Patient Diagnostic System user s manual After the license file has been installed the FLASHLIGHT Rest ECG software is ready to operate The li cense file allows the applications ordered and listed on the delivery note to be operated Hardware installation Once the software has been successfully installed the FLASHLIGHT sensor and optionally a blood pressure monitor must be installed This installation is described in the PADSY The Patient Dia gnostic System user s manual in the Installation of Hardware Components section FLASHLIGHT Rest ECG System for PADSY from Version 3 5b System Elements and Components Page 15 Before the completion of the installation set the serial port for the device This setting must only be made once as long as the device is always connected to the same serial port 2 7 Starting FLASHLIGHT Rest ECG Using The FLASHLIGHT Rest ECG Software displays the recorded ECG signals on the screen in real time To prevent any display delays occurring ensure before starting the software that e no other Windows application is activated on your PC in addition to the practice DP system e no screen saver has been set up under Windows display options The
37. e later one has an amplitude of at least 300 pV the following information appears Late R in The information is given for the leads AVR V1 and V2 A QR configuration is required and in lead AVR a Q time gt 30 ms Q amplitude lt 200 uV and R amplitude gt 200 uV or in lead V1 V2 a Q time gt 30 ms Q amplitude lt 200 uV and R amplitude gt 300 pV A reference to a late R also occurs if the QRS configuration not only consists of a Q wave and a R wave but also when either a small R wave with an amplitude lt 50 uV appears in front of the Q wave or with an amplitude gt 50 uV at the end of a S wave Abnormal R S in The R S ratio is investigated only in the leads V1 and V2 This information is given only if the amp litudes of the waves exceed 500uV and if in lead V1 the R amplitude is gt 0 85 S amplitude in men or the R amplitude is gt 0 65 S amplitude in women and in lead V2 the R amplitude is gt 1 80 S amplitude in men or the R amplitude is gt 1 50 S amplitude in women Small S in This information also applies only to the leads AVR V1 and V2 for which the following criteria must be met in lead AVR S amplitude gt 500 uV or in lead V1 S amplitude gt 300 uV or in lead V2 S amplitude gt 300 uV Wide S in S waves play a major role in the detection of infarctions right bundle branch blocks and left anterior hemiblocks They are checked only in leads I II AVL and
38. em for PADSY Rest ECG from version 3 5b Version 6 Modified 01 2006 GBA FL 3_5 EN odt Copyright 2006 Medset Medizintechnik GmbH PADSY and SCANLIGHT are registered trademarks of Medset Medizintechnik GmbH Windows is a registered trademark of Microsoft Corporation Medset Medizintechnik GmbH Curslacker Neuer Deich 66 D 21029 Hamburg Deutschland Telefon 4 49 0 40 725 822 0 Fax 49 0 40 725 822 11 e mail info medset com http www medset com FLASHLIGHT Rest ECG System for PADSY from Version 3 5b General Information General Information The FLASHLIGHT Rest ECG System for the Patient Diagnostic System PADSY bears the CE mark C 0124 according to Directive 93 42 EEC of the Council with respect to medical products and complies with the fundamental requirements of Annex I of this Directive The CE mark includes only those parts listed in the section Accessories and in the EC Declaration of Conformity FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Contents LAPpucatiOn and FUNC ON wessesceteveicecsecesssccedeuuecsieesvoscsindeceetecackccuestiesectavesacciaie O Bed BASIC PFINCIPlES sascssiicacveccensecsceaddesvcscusducscecsaceedeeceusustceusevsscesscseus dues ESE 8 1 2 Rest ECG INGicat On s icusccsiesscccccesccsuceseceuswacsecenssssocecessswaecssdenccstwabcededscevsdestevdecevennensucedseedes 8 WS SAT OLY sxesevestceivaccisuavecwsvise ses TT EEEE E T OE EET TEOST testes 8 2 System Elements and Com
39. en Compliance is required with the stated ambient conditions D Magnetic and electrical fields can influence the recorder function Ensure that during opera tion all non Medset equipment operating in the vicinity complies with the relevant EMC require ments X ray equipment tomographs etc can cause interference in other equipment asa result of their authorized higher emission of electromagnetic interference D FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Application and Function Page 11 Equipment shall be interconnected or connected to parts of systems only when it is ensured that the safety of patients personnel and the environment is not endangered by this connection Where safe connection is not directly indicated in the equipment data sheet the user must ensure for ex ample by checking with the manufacturers involved or by consulting an expert that the safety of the patient personnel and the environment is not endangered by the intended connection Compli ance is required in all cases with the standard IEC 601 1 1 EN 60601 1 1 eo D Coupling of several appliances can lead to a summation of leakage currents and thereby repres ents a possible danger to the patient The ECG signal can be corrupted in this fashion eo D Avoid pulling on the electrical supply cables Electrical supply cables should never be unplugged by pulling on the cable but by gripping the plug to pull it out of the socket
40. erpretation the evaluated data must not be manually entered After the ECG has been analyzed under PADSY by HES a finding for this ECG is automatically produced and displayed FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 39 An Automatic Interpretation takes place only in use of the standard lead system If another lead system than the standard is used non automatic interpretation takes place i e the text field for the interpretation remains empty Se Finding Medset Medi Navigation tree gt IP PADSY Patients Examination Holter ECG Long Term BP Rest ECG Recording Start Evaluation ECG Survey 90 gs Print out Tools Stress Test ECG Tools Product information Vertical type 692ms P 142ms QRS 89 164ms T 84 104ms 336ms QTr H 104 402ms QTc F 379ms 100 mmis Df I Message Neuer Anwender 00 00 52 This software option checks all easily visually detectable ECG criteria important for diagnosis and makes them available as analytical indications together with the rhythm overall assessment and QRST T evaluation With the help of the keyboard the finding can be further extended To do this click in the evaluation window Click the HES finding button in the information and operating field to reset the finding This is made automatically by the analytical software An attempt has been made to
41. ersion includes the measurement function and automatic interpreta tion of the ECG according to HES This can lead to false readings for measurements and incorrect interpretation by the analytical software For this reason the attending physician must perform a quality check to validate the results eo D Medset Medizintechnik accepts responsibility for its products in respect of their safety reliability and function only when the products are used according to the instructions outlined in this user s manual o D FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 10 Application and Function Disposal of the equipment and accessories at the end of its life must be performed according to lo cal electronics disposal regulations or by sending the old equipment to Medset at the customer s cost where Medset will dispose of the equipment appropriately eo D Liquids must never penetrate the interior of electrical equipment If liquid has entered the recorder it must be returned to Medset customer service for testing before it is used again eo D eo D Dispose of packaging material appropriately Ensure that it is out of reach of children The user is responsible to ensure that before each use the functional safety and operating condi tion of the equipment is checked eo D These products are not intended for operation in explosion hazard designated areas resulting from anaesthetic skin cleaning
42. es 57 FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 8 Application and Function 1 Application and Function 1 1 Basic principles The the ECO and SCOPE versions of the FLASHLIGHT Rest ECG System consists of an ECG sensor mod ule with a serial interface cable a patient cable and evaluation software The ECG is recorded using a 10 core patient cable attached to the patient s skin and processed by the ECG sensor module for transmission to the PC The FLASHLIGHT SENSOR Type SE ECG sensor module conveys the surface ECG to a USB port using a PC interface cable The ECG amplifier FLASHLIGHT SENSOR USB transmits the surface ECG through a interface cable to the USB interface of a computer The 3 6 or 12 channels of the ECG signal can be shown on the monitor The FLASHLIGHT Rest ECG Software for PADSY is an application of the patient diagnosis system PADSY FLASHLIGHT cannot be used without the PADSY software Please refer to the PADSY The Patient Diagnostic System user s manual supplied together with the FLASHLIGHT PADSY for all rel evant information ECO and SCOPE versions of the FLASHLIGHT Rest ECG System The ECO and SCOPE versions of the FLASHLIGHT Rest ECG system is used by medical personnel and doctors It is used for in patient and out patient diagnosis and treatment monitoring The ECO and SCOPE versions of the FLASHLIGHT Rest ECG system is attached to patients by doctors and medical personnel and is used f
43. es must not be allowed to contact any electrical equipment electrical sockets conductive or grounded objects Check that the electrodes are safely separated from all electrical devices and sockets before the patient is connected to the recorder via the electrode cables D When electrodes are applied RF equipment e g electrosurgical equipment must not be operated There is an elevated risk of localized burns to the patient D Patient safety maintenance of equipment function and optimum interference immunity are ensured exclusively with original Medset accessories or with the accessories and consumables recommended by Medset Medset cannot guarantee the safe and accurate operation of equipment used with differ ent accessories and consumables eo D Only use accessories that are listed in this user s manual because they have been tested in con junction with the equipment If non Medset accessories are used Medset cannot guarantee their safe operation and function D No claims under warranty can be validated for damage resulting from the use of non Medset ac cessories and consumables D Software programs can conflict with one another Where it is not absolutely beyond doubt from the documents supplied with the program that such conflicts are not possible the user must avoid such conflicts by for example consulting the manufacturers concerned or an expert D The software for the SCOPE v
44. ey Finding Print out L Measuremel amp Tools Stress Test ECG Tools Product information 23mm s Smm my j i 1 Lic Lm FLASHLIGHT 3 00 PAOSY Sta 12 Kata KG Vastihko Nadsat Nalk ntxchnik Gebel E Ansett syste H Nusclo Sitor H 50 650 Hr Siir Message Neuer Anwender 00 11 14 The header of the printout consists of heart rate patient data recorded data and practice or hospital data including the name of the examiner and analyst HF bpm Patient leiet Feii Recording from 02 Dec 2003 15 55 31 Practise Oimc Heiset Meditedank GmbH Carsten Florian Date of birth 25 May 1951 52 Years Blood pressure mmbg Steet Curslacker Never Deich 66 Patient AP r Town 21029 Hamburg 86 Sea Size Weight female cm kg Reco mer Heuer Anwender Pace maker Hein Finder The following window appears when the print settings are recalled Y Print settings Speed setting 25 mm s 2 50 mm s Amplitude setup 20 mm m 10 mm m 5 mm m O 2 mm m It allows the settings for feed and amplitude to be changed For this purpose click on the field in front of the desired parameter with the left mouse button The changes are directly visible in the print preview Measurement Selecting the Measurement window automatically loads the associated print preview In this window the findings the type of cardiac position the tabulated ECG values obtained with the HES analysis as well as the rhythm
45. g P contour and or T contour e At least three cycles of the main type are necessary to create a representative cycle 8 1 2 Intervals Global measurements are determined i e those jointly valid for the leads such as Q R and S times in milliseconds as well as spatial values e g frontal vectors After selection of the Printout gt Measurement view these measured values will be found under the Cabrera circle Interval measurements are marked with a if they deviate from the following values P time gt 128 ms PQ interval gt 128 ms QRS time gt 100 ms The so called frequency corrected QT times shown are determined using the following formulae QT QTc B JRRIs following Bazett QT QTc F YRR Is following Fridericia T QTr H __ l 100 following Holzmann 0 39 RR ms FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Appendix Page 51 8 1 3 Amplitudes The maximum amplitudes are output for Q R S J and ST For better differentiation the maximum amplitudes obtained for the P wave and T wave are output separately for the positive and negative value ranges 8 2 Interpretation All visually easily recordable ECG criteria important for diagnosis are investigated in the program and made available to the user as evaluation information The P Q R and S times and amplitudes are measured in each of the twelve leads and compared with the associated 96 limits in normal groups
46. he system 1 Shut down the PC 2 Check whether the sensor has been connected to the PC in accordance with the section Con necting the FLASHLIGHT sensor Start up the PC and the FLASHLIGHT software for PADSY Check that the sensor has been set up on the PC according to the section Hardware Installa tions FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Technical Description Page 47 6 Technical Description 6 1 Classification Hardware Protective class Safety class DIMDI UMDNS No Electrical data Status display Measuring interface Frequency response Sampling rate Accuracy Sensitivity Common mode rejection Input resistance Calibration Calibration voltage Electrical isolation Power supply Power consumption PC interface Transmission rate Transmission indication Immobilization Physical data Dimensions Weight Operating conditions Temperature Relative humidity Atmospheric pressure Storage conditions Temperature Relative humidity Atmospheric pressure Class IIa medical product with measuring function according to EU Directive 93 42 EEC Annex II Regulation 10 Protective Class II equipment according to EN 60601 BF according to EN 60601 for ECG sensor module without acces sories defibrillation protected according to EN 60601 10 981 Green LED 8 AD channels with 12 bit resolution 0 05 to 150 Hz approx 1 400 Hz with 4 channe
47. ipers are closed again by clicking the left hand mouse button twice in quick succession in the zoom window Furthermore the measuring points set by the system can be moved in the lower part of the zoom window The changes to the resulting measuring points are visible at the same time in the measure ment window The changed measuring points are shown in red for easy comparison with the original points shown in black 150 mmis Please note that the statement Automatic HES analysis in the lower part of the printout will only appear if the measuring points have not been changed eo D Using the right mouse button the amplitude and feed can be set and all cycles can be superimposed over each other The original values of the HES analysis can also be restored FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 37 The right mouse button will open the Zoom window settings menu Using the settings menu in the zoom window all of the representative cycles can be displayed in addition to the known settings Amplitude O 25 o Speed HO 50 Lead bm 76M G 100 a O 150 Selecting All will superimpose all representative cycles The selected cycle appears in black all oth ers in gray 150 mmis If the measuring points set by the system in the lower part of the zoom window were moved they can be reset by clicking on Original values As in the Start window the amplitude can be ch
48. l ECG approx 500 Hz with 12 channel ECG 2 44 uV per bit with a sensitivity of 5 mV 4 88 uV per bit with a sensitivity of 10 mV automatic 5 mV or 10 mV gt 100 dB with power line filter selected gt 10 MOhm Automatic detection of zero voltage 1 mV Via optocoupler with an insulation voltage of 4 kV Via keyboard interface with a PS 2 adapter approx 400 mA at 5 V RS 232 or USB approx 115 000 baud Yellow LED Automatic rapid discharge of block capacitors e g after defibrillation approx W 67 mm H 45 mm D 158 mm approx 440 g incl PC interface cable 10 C to 40 C 25 to 95 without condensation 700 hPa to 1 060 hPa 20 C to 50 C 15 to 95 without condensation 500 hPa to 1 060 hPa FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 48 Technical Description 6 2 Software Display Immobilization Electrode detection Overload display Lead systems Standard Cabrera Nehb Left precordial Right precordial Pacemaker spike detection Detection Heart rate display Frequency range Calculation Filter Power line filter Muscle filter Antidrift filter Manual rapid discharge of block capacitors e g after defibrillation Automatic display of electrode status Superimposition of all ECG channels with a red bar Einthoven Goldberger and Wilson V1 to V6 Einthoven Goldberger and Wilson V1 to V6 Einthoven Goldberger Nehb and Wilson V
49. l space on the right anterior axillary line Height C1 on the right medioclavicular line Sth rib between left sternal margin and left medioclavicular line 5th intercostal space on the left medioclavicular line Height C4 on the left anterior axillary line Height C4 on the left mesial axillary line Right leg The electrode system for the User defined lead system corresponds to the standard electrode sys tem 2 8 2 General The following display appears under the General tab FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 20 System Elements and Components A Program settings Navigation tree x E l evap er stem General SY atients i amination Recording duration Frequency settings for notch filter maneu 7 10 seconds 50 Hz Recording Evaluation 20 seconds 60 Hz Tools a mrrogram settings amp 30 seconds Stress Test ECG F 2 60 seconds Long Term BP Filter settings for evaluation ols i 7 120 seconds iw Antidrift oduct information me 180 seconds ivi Muscle Ivi 50 60 Hz filter Switch to evaluation Filter settings for execution s On ICa Antidrift Off ivi Muscle i 50 60 Hz filter Pacemaker detection Filter adjustments for analysis No detection I Antidrift C1 Muscle TEE 50 60 Hz filter C3 x 7 Message Heidi Kabel 00 03 53 In this display the settings that are preselected for performing and evaluating a Rest
50. ld be saved at this time D To exit the Start window click the following button to interrupt the connection XJ Or use the following keyboard shortcut lt Q gt 3 4 2 Recording an emergency ECG An emergency ECG is already integrated in the system This means that FLASHLIGHT PADSY is able to produce and print a Rest ECG recording in the shortest possible time Please read the previous section for a more detailed description The procedure for an emergency ECG after starting the Rest ECG is as follows 1 In the navigation tree switch directly to the Start view or press the Start button in the Record view 2 Carry out the standard electrode placement 3 Click on the memory button The ECG recording can be saved according to the presettings 4 The following window appears FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 31 by Assign the recording to a patient Patient data Name First name Sex unknown Date of birth Street Height cm Address Weight kg Pacemaker Comment List of all stored Records 9 of 9 not filtered Name First name GOT No Identification a a First name Identification Big AVB I RSB evtlL Demo Rest Dilatation Pre Post Demo NIBP Hypertonie Demo NIBP Kammerrhy LSB evt Demo Rest Pri nt o ut The following actions are carried out by clicking on the buttons at the bottom of the windo
51. ls Stress Test ECG Filte Tools Product information wi Drift lz Muscle Power eer 25 mm s Filter Drift Muscle Power line 15 57 01 CO a a a a aS 155709 kY Aine Ce Zed Tn cn Dae Dae ae Aan ae hae 15 57 18 imara AAA RRR RRR f A 15 57 26 y y n y if Y na Y E li re eH i PERTEN St 4 gt LSL 15 57 35 iana Ir l 15 57 44 vE nt Me See ae eed A eee eee eee eee eee en gt X a 15 57 52 ha i g a a m g a i ai aa Seema Ga Message Neuer Anwender 00 02 06 Measuring the ECG signal Calipers are used to measure the ECG signal which can be called up in the ECG signal field Move the mouse pointer to the position which desired to be the first measuring point Keeping the left hand mouse button pressed the calipers can be opened by moving the mouse horizontally and thus defin ing further measuring points In order to allow exact positioning the calipers are divided into three parts The caliper appears as follows FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 34 Operation Il i With the left mouse button pressed the calipers can be moved provided that the mouse pointer is placed on the measuring range of the calipers when the button is first clicked Clicking outside of the calipers on the ECG signal causes the calipers to jump in the direction of the mouse pointer Alterna tively the calipers can also be folded to the right with the lt
52. n and accordingly a rising number of points added for a time of over 100 ms In the case of a QRS complex of over 134 ms information is provided on infarctions and left ventricu lar hypertrophy with a reduced confidence value uncertain check Bundle branch block data and variables tested e Complete right bundle branch block QRS start to ENB in Amplitude of the negative T maximum in V R amplitude in V1 R1 amplitude in V1 gt RO amplitude in V1 R1 amplitude in AVR Sum of S time in V5 S amplitude in V1 Sum of S time in V6 FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Appendix Page 55 S amplitude in V6 QRS frontal angle e Complete left bundle branch block Q time SO time and S1 time in V1 Amplitude of the negative T maximum in V 5 Amplitude of the negative T maximum in V6 QRS start to ENB in I Q time in V5 0 Q time in V6 0 QRS start to ENB in AVL QRS start to ENB in V5 QRS start to ENB in V6 e Incomplete right bundle branch block R1 amplitude in V1 R1 amplitude in AVR R1 tIme in AVR S time in V5 S time in V6 e Incomplete left bundle branch block QRS start to ENB in I QRS start to ENB in AVL QRS start to ENB in V5 QRS start to ENB in V6 ENB Start of final negativity movement RO R1 here represent R R etc e Left posterior hemiblock Q amplitude in I 0 Q amplitude in AVF Initial QRS frontal angle Maximum QRS frontal angle S amplitude in I Q amplitude in II
53. nt settings can be configured The printouts which should always be made may be selected by clicking on the appropriate buttons These will then always be selected in the evaluation for new recordings Furthermore presettings for the individual printouts can be selected The following window appears by clicking on the ECG button Speed setting g 50 mm s Amplitude setup O 20 mm m O 10 mm m 5 mm m O2 mm m 0K Presettings for the feed and amplitude of the printout can be defined here The following window appears by clicking on the button Measurement button FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 22 System Elements and Components Speed Complex Table Lead system 2 Standard 50 mm s No 1 Ov Amplitude Complex Amplitude Strip DI Ove i 20 mmm 2 20 mm mv C111 COG O 10 mm m 2 10 mm m zie mae 2 aL V5 5 mm mif w 5 mm mi C aVF Co V6 D2 mm mif 2 mm m Settings for the feed and amplitude of the representative cycles can be made here In addition the table with the measurement values can be faded in and out A drop down menu to select the lead sys tem is also available Furthermore the amplitude and the leads of the rhythm strip can be selected Confirm all changes to the settings by clicking on the OK Button FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 23 3 3 1 3 2 3 3 Operation The basis for working
54. of Q amplitude and Q time in nor mal groups FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 52 Appendix e QSin This information is provided in the case of a missing R wave if the negative amplitude is be low 500 pV e R loss in This information does not indicate a missing R wave but refers to a R amplitude below 100 uV It is thus adding emphasis to the reference for a small R wave Small R in A deviation of 4 quantile of the R amplitude in normal groups is checked in the leads not in AVR lead as with Q waves R amplitude pV 250 350 50 50 50 50 150 290 450 750 550 4 quantile of the R amplitude in normal groups Wide R in This information appears if the R time exceeds the limits stated below R time ms I 80 ITI 80 AVR 55 AVF 80 V1 45 V2 60 V3 80 V4 80 V5 80 V6 80 96 quantile of the R time in normal groups High R in This information appears if the R amplitude exceeds the limits stated below FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Appendix Page 53 R amplitude pV 1500 2100 1700 360 1100 1900 96 quantile of the R amplitude in normal groups Wide R in The 3 leads AVR V1 and V2 are checked This information appears if in lead AVR the R time is gt 55ms_ or in lead V1 the R time is gt 45ms or in lead V2 the R time is gt 60ms High R in If two R waves exist in a lead and if th
55. of the FLASHLIGHT Rest ECG system for PADSY which is recom mended after the installation phase The Troubleshooting section looks at typical errors 5 1 Function test The procedure for a complete test of the FLASHLIGHT Rest ECG system for PADSY is as follows Refer to the relevant sections in Chapter 4 Operation to carry out individual functions if unfamiliar with them 5 1 1 Testing the sensor connection 1 Connect the sensor to the PC 2 Start the FLASHLIGHT software 3 Set up the sensor in the system 4 Open the Record view and check that the sensor connected has the status Ready to operate 5 1 2 Testing the record function 1 Click on the Record view and then the Start view in the navigation tree 2 Record a Rest ECG while pressing the red memory button 3 Save the Rest ECG under a test name 5 1 3 Testing the hard copy 1 Select the Evaluation view and then the recording saved 2 Switch on the printer 3 Select the Hard copy view in the navigation tree 4 Click on the Instant Print button and check the hard copy 5 2 Troubleshooting If the software does not function at any time the following problem solutions are suggested The Medset customer service will be pleased to provide additional support if these suggestions do not solve the problems Please refer to the Troubleshooting chapter in the PADSY The Patient Diagnostic System users manual as well No sensor is detected by t
56. or disinfectant substances or in areas with flame promoting atmospheres as a result of gt 25 oxygen in the ambient air or nitrous oxide in rooms used for medical pur poses D Mains operated equipment must only be connected to grounded socket outlets Extension cords and multiple socket outlets must not be used with medical equipment D Before connecting the equipment it must be ensured that the mains voltage and frequency cor respond to the specifications on the nameplates fitted to all mains operated equipment eo D Mains connections and cables must be checked before connection Damaged cables represent an extreme danger to all persons who knowingly or unknowingly come into contact with them They also endanger the electronic circuitry of the connected equipment Damaged cables and mains con nections must therefore no longer be used for the operation of electrical equipment They must be returned to Medset for exchange eo D Disconnect the equipment from the mains supply before removing the connecting cables from the equipment by first removing the plug from the socket outlet Only then remove the connecting cables from the equipment Otherwise there is a danger of personal contact with the mains voltage resulting from accidental introduction of metal parts into the sockets of the equipment connecting cables eo D There must be no obstruction to equipment cooling air circulation Air vents must remain op
57. or recording and evaluation of 12 lead Rest ECG tests Once started the system records a 12 lead superficial ECG of the patient through the patient cable and electrodes for a period of up to 180 seconds and saves the data The saved ECG is immediately made available to the doctor for interpretation evaluation on monit or viewing and printing out The evaluation software can be run on all standard PCs with a Windows operating system or MACOSX The results of evaluation can be printed out on a standard Windows printer The SCOPE version includes an additional ECG analysis program based on the HES system The Han nover ECG program system for computer assisted evaluation of electrocardiograms with automatic complex formation and ECG measurement The SCOPE version can also be expanded with the HES in terpretation module which can be used to automatically suggest evaluation hints and diagnostic opinions These hints and opinions naturally must be verified by the physician and corrected if ne cesSary It is assumed that attending physicians have adequate specialist knowledge to interpret and diagnose ECG results correctly The patient does not influence the recording 1 2 Rest ECG Indication The Rest ECG is an important source of information in cardiac diagnosis The Rest ECG is used for the clarification of thoracic pain and to diagnose cardiac arrhythmias lesions in the coronary arteries and enlargement of the heart muscle 1 3
58. ording of a Rest ECG begins by changing to the Start window LAE Ss Medset Medi 56 2 En LL ee Channels i KA Filter li Dnft ze b S P R E 6 E ines s Power ny 10Seconds 9 lX 50 mm s Filter Drift Muscle Power line Message Neuer Anwender jo1 1 2 43 e Information and operating field The information and operating field shows the currently measured heart rate FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 28 Operation The heart rate that is displayed can be di tion eart pacemaker impulses or by atrial fibrilla eo D The field Channels allows selection of the number of channels to display E Channels Boe ba ma me a e l n E By activating the buttons it is possible to directly select 3 6 or 12 channels If 3 channels were se lected to be shown one below the other 9 channels can be displayed in the field Channels by click ing on the arrow keys The arrow pointing upwards displays the previous set of channels and the ar row pointing downwards displays the next set of channels Furthermore the following display appears in the ECG signal field 50 mm s Filter Drift Muscle This displays the feed rate and filter that have been selected By clicking on the arrow keys the leads shown may be changed when 3 or 6 channels are displayed The respective filter can
59. provide the user with the essential information about the special fea tures of the ECG in a condensed form The findings are divided into the following 4 different sections Rhythm In this section Rhythm analysis are made e g the extent to which a rhythm is regular or irreg ular and whether it is determined by the sinus nodes or by a different excitation center The rhythm analysis takes into account the RR intervals the P wave and PQ interval the morphology of the QRS complex and coupling relationships Information on findings The information on findings should draw the attention of the physician to abnormalities In many cases therefore the subsequent QRS T evaluation will be simplified or confirmed Specific information is provided on retardations incomplete as well as complete bundle branch blocks preexcitation prob lems WPW hemiblocks and non specific intraventricular disturbance to ventricular stimulus With an abnormal ST T wave repolarization disturbance of the inner or outer layer type is assigned accord ing to grades 1 4 The findings are provided on the basis of time and amplitude of P Q R and S for all 12 leads and their deviations from normal values FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 40 Operation These limits or normal values are tabulated in the Appendix The information on findings briefly ex plained in the Appendix consists of Notes on the P wave Notes on the QR
60. r off The antidrift or baseline filter serves to equalize fluctua tions in the ECG signal around the baseline The 35 Hz muscle filter suppresses muscle artefacts The 50 and 60 Hz main filter compensates for noise which is generated by the PC power supply Settings Choose Settings in this menu or press lt F10 gt in order to select the channels displayed switch fil ters on or off or to specify the feed rate and amplitude The following window appears FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 24 Operation yo ECG settings Signal Raster pa Filter Channels Ou ud Drift IJ Muscle I Power line Feed Amplitude 100 mm s 25 mm mvV 50 mm s 20 mm mvV 3 25 mm s 15 mm mV 312 5 mm s 10 mm mvV 5 mm mV 2 mm mvV The field Channels allows the selection of the number of channels displayed F Channels YOu By activating the buttons it is possible to directly select 3 6 or 12 channels If 3 channels were se lected to be shown one below the other 9 channels can be displayed by clicking on the arrow keys in the Channels field The arrow pointing upwards causes the previous set of channels to be dis played and the arrow pointing downwards causes the next set of channels to be displayed Keyboard abbreviations for the settings of the channels Display 3 leads lt 1 gt Display 6 leads lt 2 gt Display 12 leads lt 3 gt Leads up lt Page up gt Le
61. s After positioning the mouse pointer on an ECG channel designation you can drag the ECG channels horizontally with the left hand mouse button pressed FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 26 Operation 3 4 Re establishing the arrangement Press the lt F9 gt key on the keyboard Changing the amplitude Position the mouse pointer on the 1 mV calibration waveform in front of the ECG signal You can now increased or reduce the amplitude of all ECG channels simultaneously with the left hand mouse button pressed Recording a Rest ECG Selecting the menu option Recording causes the following display to appear on the monitor a 5 Sg Recording Medset Medi Navigation tree x ser Records 9 of 9 not filtered Patients Name First name GDT No Identification Examination Holter ECG Long Term BP Rest ECG Identific Name First name Date of birth tecordings GDI ID Created Last change fecording Demo Rest Big AVB I RS 18 Nov 1925 13 Apr 20 13 Apr 2004 Demo NIBP Dilatation Pre 03 Jul 1961 13 Apr 20 13 Apr 2004 Evaluation Demo NIBP Hypertonie 11 Aug 1956 1 13 Apr 20 13 Apr 2004 Demo Rest Kammerrhy L 06 Feb 1919 1 13 Apr 20 13 Apr 2004 Hansen Klaus 1a Dec Ekan 5 13 Apr ace 13 Apr 2004 Medi edset lay 1951 8 13 Apr 20 12 May 2004 Demo Holter Schetimacier TENE 1919 1 13 Apr 20 13 Apr 20
62. sesesceweseves sdeoweseieoedeeceneeseus saveceew ees tee ICETA Ea 46 6 Techical DESCHID TION civissecacesciawcewsancevtesadenibiceseciniocceseenecclcsweaswinscchateieveaseteustiateaieavee cE 6L HAL WaAl Cece dessecsevenesaceascssvcatecaconseasessasehcnnsesesnsdcnswaesccaenssanesaveasensedeaeceseece saceaeesesecuscusadeeses 47 O52 SOPLWAl Criss cencosscsucsacesnvasacSususedesenedes venavesuenedenecnauesseueesecnieus sasdccescbuveveensndveseseaneeasesawseedaees 48 T Accessories ANG CONSUIMADLES vindiessscesiccsescsvessesesncseteesecesseceseessvesdeacsiasseteccecssneseseesseeseseece 49 TEV ACCESS OMICS vaiesipsic ce ries ea IEE ESEESE ces ccQiecbveavenueaslebicucdeswtedeetusn deus veendstecevestes 49 1 2 CONSUMADIES sssscssuccsceesehedcevasscceusna seas sceessspnaaesusecesacnuecesuvaceetevadeubevedestavacsesssacevevsaccesaxese 49 SPD DEIN sere csvceucervacseacveescsvcacese de seaccetavcus cae cosucdses cave vaecdetwiseceu costal ssteessusesetvassareseouseesue OU 8 1 Measurement csc ccccccconsccecunodednwsseossanecasaedcnseocdsscadeseancsavencedenseeseuedsncrsocssdcedsetoonseassaseseousss 50 Gade E Representative Cycle Senei a E 50 Se IMEA oa e a a A 50 S E AMPUESSA Gan aude taGuea ae seegesenmereesaneewlans 51 9 2 INLERPVETAU OM sxecdvedwenssdvesnteesoruseseus sieeve cba cuasedusadevaucsadeneousedacestveascvetuscssssavesiececeveuseesueiads 51 8 3 EC Declaration OF Conformity iiss cs siicetscesscesecdsccssebecdesiesecsedsececcicedescdosceecendceseasvesetsedceseced
63. st ECG Recording Evaluation ECG Survey Measuremer Tools Stress Test ECG 7 Selection Number of pages Long Term BP a Product information Measurement Measurement Total x lt Generating PDF Report Instant print Message OEN 00 01 01 Clicking the fields under Selection allows to select the sections that are to be printed The fields signify the following This section is selected for printing een This section is not selected for printing FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 41 The number of pages of a section are shown on the right hand side of the window and the total number of pages are found at the bottom The report print out can be made in two ways It can be created either as a hard copy from a printer or as a pdf file To start the report printing from a printer select the Instant Print button at the bottom of the window To save the report as a pdf file click on the Create PDF report button at the bottom of the window By clicking Instant print at the bottom of the window the marked section is printed without clos ing the data record The user must wait until all pages have been transferred to the Windows print manager before closing the application Selecting Create PDF report opens a window that allows the user to select the folder where the pdf report is to be saved To open a pdf file Acrobat reader is required Buttons
64. tted Following DIN EN 60601 1 all types of Recorder Opto Interface Cables have been designed so that they can be operated fully isolated and with complete electrical decoupling from the PC This meas ure in conjunction with the following method of installation see illustration below allows PC Supported online monitoring of the ECG signal from the patient in rooms used for medical purposes PATIENT ae oO l I Nn lt u FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 14 System Elements and Components 2 4 eo D eo D 2 5 2 6 PC monitor and printer must be installed so as to maintain a minimum distance of 1 5 m from the patient If the ECG sensor module with the PC interface cable is operated solely within the patient environ ment and a distance to the patient is maintained of at least 1 5 m to the PC or to other office equip ment connected to it no further measures are necessary to ensure the safety of the patient If it is not possible to comply with the distance of 1 5 m between patient and office equipment ac ceptable measures for reducing the case leakage current are required These measures include e additional grounding conductor connecting parts or e an isolating transformer with safe electrical isolation or e equipotential bonding or e an additional non conductive case All these measures should be carried out strictly according to the regulations of
65. ved recordings Status The status list of the selected recording is displayed This will be discussed further in the next section Setting the status GDT export Recording information can be exported via the practice EDP program Note the settings for the GDT interface described in the PADSY The Patient Diagnostic System user s manual or in the help system Setting the status Exiting one of the windows in Evaluation view for a higher level or selecting the Print window the following status query appears The status is set by clicking on the check box The settings become effective by clicking OK FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Operation Page 33 Please select examination status AET Ok I Details With Details the User and the Date corresponding to the current status is shown When a recording is marked as evaluated the relevant user appears in the printout with the desig nation Examiner and no further status query appears eo D Please note that a status once set cannot be reset 3 5 1 ECG The ECG window is used for retrospective observation of Rest ECG recordings It differs only slightly from the Start window m Navigation tree x HF PADSY 7 Patients Examination Holter ECG Long Term BP Medset Medi 8 Rest ECG Recording Evaluation vii Channels Survey D Finding Print out Too
66. w e Prnt Direct printing of the ECG recording using the standard windows specified printer e Save Before saving the minimum data Name First Name and Date Of Birth for the patient must be entered in the Patient Data field If the patient s data is already present in the system select it from the List of Stored Patients with the scrollbar and mouse e Reject The ECG recording is neither saved nor printed The user is returned to the Start view en abling a further ECG recording if necessary 3 5 Evaluation Selecting Evaluation from the navigation tree a list of all Rest ECG recordings that have been stored on the system appears The recordings are sorted by patient For multiple name entries a corresponding number of Rest ECG recordings have been made with this patient FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 32 Operation amp Evaluation Klaus Hansen as Z Records 12 of 12 not filtered Patients First name GDT No Identification Status Period Examination B Aat v au O o o v Holter ECG Long Term BP Rest ECG sor ID Identifica Name Z First name D ate of birth Start of the reco l Status Recording Demo Rest Sinusarrhy normal 06 May 1938 03 Jun 1983 12 01 evaluated Start Demo Rest VHF Hypertrophie 13 Feb 1925 14 Sep 1981 12 01 Demo Rest Big AVB I RSB evt 18 Nov 1925 12 Dec 1988 12 01 ECG Demo Rest Kammerrhy LSB e
67. waves When this finding is present for an ECG alone then the overall assessment of normal is possible Grade 2 I point reduced by less than 0 1mV with a slightly trough shaped ST segment with a transition into predominantly positive T waves Compatible with slight re polarization disturbances of the inner layer type Grade 3 I point reduced by at least 0 1mV with horizontal or descending ST segment with a transition into a T wave inverted by greater than 0 5mV which does not rise again above the iso electric Compatible with medium severe re polarization disturbances of the inner layer type Grade 4 I point reduced by at least 0 1mV of which the ST segment descends more steeply with complete T inversion by more than 0 5mV Compatible with severe re polarization disturbances of the inner layer type Outer layer damage Re polarization disturbance of the outer layer type are graded according to the development stage Grade 1 Slightly sagging ST deflections rising out of the descending R deflection with a transition into exclus ively positive T waves ST deflections raised by at least 0 2 mV in the chest lead and 0 1 mV in the extremities lead Compatible with early stage re polarization disturbances of the outer layer type Grade 2 Raised outgoing ST deflections from the descending R deflection with transition into a slightly ter minal T negativism Compatible with transitional stage re polarization disturbances of the outer layer
68. with FLASHLIGHT Rest ECG is the PADSY Patient Diagnostic System First famili arize yourself with PADSY by reading its user s manual before Rest ECG recordings are made General Window separator In the ECG view there is a window separator under the ECG signal window with which the window size can be increased or decreased The window size can be changed by operating the window separator with which the width of the navi gation tree can be altered the height of the window above and below the window separator is deter mined by shifting the gray bar with the mouse Settings In windows where additional setting options are available such as the Start and ECG windows a menu is available which makes function selection or quick settings changes possible e Right mouse button Once the right hand mouse button in the ECG signal field has been pressed the mouse pointer can be positioned at the desired attribute and the selection can be confirmed by clicking the left mouse button If an arrow appears in the right hand margin of the menu as it does for example in the ECG signal window in the Start display next to the attribute Amplitude an additional menu opens from which the desired selection e g 5 10 15 20 25 or 30 mm mV can be made H Britt H Muscle I Power hne settings F10 For setting the feed rate please proceed similarly to what was done to set the amplitude Here the filters can be switched on o
69. with the following meanings are located in the lower part of the various print preview screens Save the page as a PDF file format The folder in which the file is to be saved can be se lected as with the import and export of data records If you scale more or less then 100 the mm Raster of the ECG print out is not correct any longer Save the page as a file in JPG format The image file may be viewed later in a graphics processing program The folder in which the file is to be saved can be selected as with the import and export of data records Print the page displayed Show first page One page back One page forward Show last page Show entire page width T Show entire page height Print window zoom in Print window zoom out 5 Call up print settings fy pp g ECG Selecting this window will load the ECG print preview FLASHLIGHT Rest ECG System for PADSY from Version 3 5b Page 42 Operation NERD ECG Medset Medi Navigation tree x PADSY Patients to Examination HF bpm Patient Mexiset Medi Recording frome 02 Dec 2003 15 55 31 Practise Climic Medset Medizartecinik GmbH Carsten Florian Date of birth 25 May 1951 52 Years Blood pressure mmHg Street Curslacher Neuer Deich 66 Holter ECG Patient ZIP Town 21029 Hamburg Long Term BP 86 Sen Size Weight one cm bg eat Neuer Anwender Rest ECG Recording Evaluation ECG Surv

Manual - PMS (Instruments)

Contents

Download Pdf Manuals

Related Search

Related Contents