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1. mode Page 18 P80Six 06 2001 General Settings Defining Lead Sequence amp Printout The required settings can be selected as follows Sequences amp Print Entry Key Sequence Definition Confirm 1 Standard Lead Sequence 2 Cabrera Lead Sequence 3 Simultaneous Print Press SHIFT 7 STOP 4 Sequential Print Key 5 Auto Centering ON 6 Auto Centering OFF Confirm the selection by pressing STOP The selectable lead groups for the P80Six are Lead Groups Standard Cabrera l V1 IH V4 aVL V1 ll V4 Il v2 aVF V5 l V2 aVF V5 I V3 IH V6 aVR V3 ll V6 aVR V4 v2 V7 ll V4 V2 V7 aVL V5 V4 V8 aVF V5 V4 V8 aVF V6 V5 V9 Ii V6 V5 V9 Leads V7 V8 and V9are only available when leads V1 V2 and V3 resp are moved to the corresponding positions manual mode Page 18 P80Six 06 2001 General Settings x The selectable printout forms are 7 a o Simultaneous All ECG leads are printed in the same time segment in ai automatic mode only Sequential Each group is a contiguous time segment of approximately 2 5 or 5 seconds in automatic mode only Auto Centering ON All ECG traces are centred dynamically for optimal use of paper width Auto Centering OFF ECG traces are set to a fixed baseline position and may possibly overlap Acoustic QRS Indication QRS BEEP The acoustic QRS indication can be switched on or off at any time by pressing the key P80Six Page
2. Page 12 P80Six 06 2001 General Settings The defined formats and settings can be checked as follows Setup Printout Entry Key Sequence Action SHIFT 0 1 1 Printout of programmed settings A printout of the defined settings will be produced and gives the following information depending on the installed software Unit designation P80Six Software option installed C Interpretation and Software version Serial number For service use Leads Standard S or Cabrera C ECG Format Long 000 Short o or Suppressed MECG Average cycles as defined in auto ECG recording setup e g 4 3 25 mm s 2 Measurements Enabled or Suppressed Marks Enabled or Suppressed Interpretation Enabled or Suppressed Selected Rhythm leads Leads selected for R1 R2 resp Automatic Centering Enabled or Suppressed Printout of signals Sequential or Simultaneous Page 12 P80Six 06 2001 General Settings I Baseline Filter 0 05 0 15 or 0 30 Hz 7 d Mains Filter 50 60 Hz or OFF 9 Myogram Filter 25 or 35 Hz ON or OFF Ww Interpretation settings N A normal abnormal is written or suppressed U unconfirmed report is written or suppressed A30 pa tient age is assumed to be lt 30 or gt 30 S low or high sensitivity To reset the unit to the basic default settings proceed as follows
3. Reset Setup Entry Key Sequence Action SHIFT 0 6 6 Reset to default base settings P80Six Page 13 06 2001 General Settings I Baseline Filter 0 05 0 15 or 0 30 Hz z Mains Filter 50 60 Hz or OFF S Myogram Filter 25 or 35 Hz ON or OFF ul Interpretation settings N A normal abnormal is written or suppressed U unconfirmed report is written or suppressed A30 pa tient age is assumed to be 30 or gt 30 S low or high sensitivity To reset the unit to the basic default settings proceed as follows Reset Setup Entry Key Sequence Action SHIFT 0 6 6 Reset to default base settings P80Six Page 13 06 2001 General Settings Language The language is selected as follows Select Language Entry Key Sequence Language Confirm German English French Swedish SHIFT 0 2 American Italian Spanish Portuguese oo Oo o AJOJN Russian Press STOP Key Confirm the selection by pressing STOP Notes Once selected the language remains active However when the unit is reset to the default settings the default language will be English Page 14 P80Six 06 2001 General Settings Language The language is selected as foll
4. With this the 2 automatic mode formats are defined as detailed on the following pages The ECG format is set as follows ECG Format Entry Key Sequence Output Format Confirm o Leads are printed in format 4 x 3 1 Rhy 1 page 12 leads 25mm s 2 1 page 12 leads 8 leads 5s 4 leads 10s 1 5 No leads are printed Press SHIFT or 1 STOP 2 6 Leads are printed in short form 1 sheet Key 7 Leads are printed in long form 2 sheets 8 Chart speed is 25 mm s 9 Chart speed is 50 mm s Confirm the selection by pressing STOP Note Lead selection for the rhythm lead is defined on page 26 P80Six Page 21 06 2001 Settings for Automatic Mode Two separate formats for the automatic ECG output can be selected as follows m a Automatic ECG Format S Entry K nir y sey Setup Format Sequence 1 Setup Format 1 SHIFT 2 Setup Format 2 With this the 2 automatic mode formats are defined as detailed on the following pages The ECG format is set as follows ECG Format Entry Key Sequence Output Format Confirm o Leads are printed in format 4 x 3 1 Rhy 1 page 12 leads 25mm s 2 1 page 12 leads 8 leads 5s 4 leads 10s 1 5 No leads are printed Press SHIFT or 1 STOP 2 6 Leads are printed in short form 1 sheet Key 7 Leads are printed in long form 2 sheets 8 Chart speed is 25 mm s 9 Chart speed is
5. With a tissue dampened with alcohol gently rub the print head to remove the ink residue If the printhead is badly soiled the colour of the grid ink will show on the tissue P80Six 06 2001 Page 35 I o iS z ui I o Rr 9 z ii Replacing the Recording Paper The recording paper must be replaced as soon as the end of the paper is indicated by a red stripe on the lower edge After the indication first appears there are about 8 pages left However we recommend that the paper be replaced immediately If no paper is left the printing process is interrupted and the paper warning lamp starts to blink After the paper has been replaced the printout is restarted by pressing COPY or MAN START or AUTO START A step by step description of how to change the paper is given on the next page Page 36 Replacing the Recording Paper P80Six 06 2001 The recording paper must be replaced as soon as the end of the paper is indicated by a red stripe on the lower edge After the indication first appears there are about 8 pages left However we recommend that the paper be replaced immediately If no paper is left the printing process is interrupted and the paper warning lamp starts to blink After the paper has been replaced the printout is restarted by pressing COPY or MAN START or AUTO START A step by step description of how to change the paper is given on the next page Page 36 P80Six 0
6. Functional tests according to the Service Handbook The test results must be documented Cleaning the Print Head If the printer is used a lot a residue of printers ink from the grid on the printer paper can build up on the print head This can cause the print quality to deteriorate We recommend therefore that every month the print head is cleaned with alcohol as follows Remove the paper tray The printhead is found under and in from the paper tray release catch With a tissue dampened with alcohol gently rub the print head to remove the ink residue If the printhead is badly soiled the colour of the grid ink will show on the tissue P80Six 06 2001 Care amp Maintenance Page 35 12 Monthly Check The unit should undergo a technical safety check every 12 months This safety check should extend to include the following e Visual inspection of the unit and cables Electrical safety tests according to IEC 601 1 and IEC 601 2 25 Functional tests according to the Service Handbook The test results must be documented Cleaning the Print Head If the printer is used a lot a residue of printers ink from the grid on the printer paper can build up on the print head This can cause the print quality to deteriorate We recommend therefore that every month the print head is cleaned with alcohol as follows Remove the paper tray The printhead is found under and in from the paper tray release catch
7. GREEN P80Six Page 29 06 2001 Patient Cable Connections x Standard Leads D a 9 zZ W C3 GREEN C4 BROWN C1 RED C6 VIOLET IEC AHA N Black RL Green C5 BLACK x Ca VERON R Red RA White RIGHT ARM RED LerTaRM vewow C White Red vi Brown Red C2 White Yellow V2 Brown Yellow C3 White Green V3 Brown Green C4 White Brown V4 Brown Blue C5 White Black V5 Brown Orange C6 White Violet V6 Brown Violet L Yellow LA Black Green LL Red RIGHT LEG BLACK LEFT LEG GREEN P80Six Page 29 06 2001 Recording an ECG in Automatic Mode In automatic mode a full 12 lead ECG is printed in one of two predefined formats with a sensitivity of 10 mm mV These two formats are selected by the user to suit his specific needs and requirements as detailed previously AUTO GAIN When the key is pressed before recording in automatic mode the unit detects very large waveform amplitudes and sets the sensitivity for the extremity and or precordial leads to 5 mm mV to reduce the overlapping of traces AUTO START To start the automatic ECG recording in Format 1 simply press SHIFT AUTO START To start the automatic recording in the second format press followed by Page 30 P80Six 06 2001 Recording an ECG in Automatic Mode In automatic mode a full 12 lead ECG is printed in one of two predefined formats with a sensitivity of 10 mm mV These two formats are selected by the user to suit his specific needs and
8. cooononnccnnnnncnnnccnncnccocnnncccnnrnnanancnn nana eene 9690029100 Carrying CASS EE To be defined Sr Troll A 9704250100 lt Patient Cable Holder inn iii 9101341000 ES crei 974044001 1 Ser Guide GB ME m 9740440015 P80Six Page 39 06 2001 Technical Data Technical data subject to change without notice Dimensions 399 x 104 x 338 mm Weight 4 25 kg 5 05 kg with full paper tray Mains Supply 100 to 115 220 to 240 VAC 50 60 Hz Baitery Built in 12 V lead acid battery rechargeable Power Consumption Recording 28 VA max Leads Standard Cabrera Paper Speed 5 25 50 mm s direct Sensitivity 5 10 20 mm mV either automatically adjusted or manually selected Chart Paper Thermoreactive Z folded 210 mm wide perforation 280 mm Printing Process High resolution thermal print head 8 dots per mm Recording Tracks man 6 channels automatic baseline adjustment Automatic Lead Programs 12 channel representation P80Six 06 2001 Technical Data Technical data subject to change without notice Dimensions 399 x 104 x 338 mm Weight 4 25 kg 5 05 kg with full paper tray Mains Supply 100 to 115 220 to 240 VAC 50 60 Hz Baitery Built in 12 V lead acid battery rechargeable Power Consumption Recording 28 VA max Leads Standard Cabrera Paper Speed 5 25 50 mm s direct Sensitivity 5 10
9. IN THE EVENT OF ACCIDENTAL LCD BREAKAGE AND RESULTANT LEAKAGE OF FLUID DO NOT INHALE INGEST OR MAKE CONTACT WITH THE SKIN IF CONTACT IS MADE RINSE IMMEDIATELY THIS PRODUCT IS NOT DESIGNED FOR STERILE USE THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE SWITCH THE UNIT OFF BEFORE CLEANING AND DISCONNECT FROM THE MAINS DO NOT UNDER ANY CIRCUMSTANCES IMMERSE THE UNIT OR CABLE ASSEMBLIES IN LIQUID THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER IF THE EARTH CONNECTION IS SUSPECT OR IF THE MAINS LEAD IS DAMAGED OR SUSPECTED OF BEING DAMAGED DO NOT USE HIGH TEMPERATURE STERILISATION PROCESSES SUCH AS AUTOCLAVING DO NOT USE E BEAM OR GAMMA RADIATION STERILISATION DO NOT USE SOLVENT CLEANERS USE ONLY ACCESSORIES AND OTHER PARTS RECOMMENDED OR SUPPLIED BY ESAOTE USE OF OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULT IN INJURY INACCURATE INFORMATION AND OR DAMAGE TO THE UNIT THE PS0SIX COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICH AFFORDS PROTECTION AGAINST EMISSIONS AND ELECTRICAL INTERFERENCE HOWEVER SPECIAL CARE MUST BE EXERCISED WHEN THE UNIT IS USED WITH HIGH FREQUENCY EQUIPMENT IT MUST BE ENSURED THAT NEITHER THE PATIENT NOR THE ELECTRODES INCLUDING THE NEUTRAL ELECTRODE COME INTO CONTACT WITH OTHER PERSONS OR CONDUCTING OBJECTS EVEN IF THESE ARE EARTHED THERE IS NO DANGER WHEN USING THE ECG UNIT FOR A PACEMAKER PATIENT OR WITH SIMULTANEOUS USE OF OTHER ELECTRICAL STIMULATION EQUIPMENT HOWEVER THE STIMULAT
10. 000 MECG none Format 2 ECG 25 mm s long 000 Measurements disabled Marks enabled Interpretation disabled Rhythm Leads V1 ECG V1 II MECG V1 ECG V1 Il MECG Autom Centering Enabled Enabled Printout of Signals Sequential Sequential Baseline Filter Setting 0 05 Hz 0 05 Hz Mains Filter Setting 50 Hz USA 60Hz 50 Hz USA 60Hz Myogram Filter Setting 35 Hz OFF 35 Hz OFF Interpretation Settings N A U A30 S P80Six Page 11 06 2001 I o E 9 z ui ENGLISH General Settings The defined formats and settings can be checked as follows Setup Printout Entry Key Sequence Action SHIFT 0 1 1 Printout of programmed settings A printout of the defined settings will be produced and gives the following information depending on the installed software Unit designation P80Six Software option installed C Interpretation and Software version Serial number For service use Leads Standard S or Cabrera C ECG Format Long 000 Short o or Suppressed MECG Average cycles as defined in auto ECG recording setup e g 4 3 25 mm s 2 Measurements Enabled or Suppressed Marks Enabled or Suppressed Interpretation Selected Rhythm leads Automatic Centering Printout of signals Enabled or Suppressed Leads selected for R1 R2 resp Enabled or Suppressed Sequential or Simultaneous
11. 20 mm mV either automatically adjusted or manually selected Chart Paper Thermoreactive Z folded 210 mm wide perforation 280 mm Printing Process High resolution thermal print head 8 dots per mm Recording Tracks man 6 channels automatic baseline adjustment Automatic Lead Programs 12 channel representation P80Six 06 2001 Technical Data Data Record Listing of ECG recording data Version C ECG measurement results intervals amplitudes electrical axes Sokolow Index average complexes with optional measurement reference markings and interpretation ECG Storage Memory for 10 s 12 lead ECG Circular input memory for 10 s 12 lead ECG Frequency Range of Digital Recorder 0 to 150 Hz IEC 0 to 150 Hz AHA P80Six Page 41 06 2001 Technical Data Data Record Listing of ECG recording data Version C ECG measurement results intervals amplitudes electrical axes Sokolow Index average complexes with optional measurement reference markings and interpretation ECG Storage Memory for 10 s 12 lead ECG Circular input memory for 10 s 12 lead ECG Frequency Range of Digital Recorder 0 to 150 Hz IEC 0 to 150 Hz AHA P80Six Page 41 06 2001 I o E 9 z ui I o Rr 9 z ii Technical Data ECG Amplifier Simultaneous synchronous registration of all 9 active electrode signals 12 standard
12. Equalisation RECORDING AN ECG IN MANUAL MODE 32 KEYBOARD 5 tret r reU ri RUP e rro 8 CARE 8 MAINTENANCE eene INDICATORS 9 Pi d FOON GENERAL SETTINOS corran 10 12 Monthly Check ieissar Defaults inre entire 11 Cleaning the Print Head szeirnt 35 Ez gre Hz To adi 14 Baseline Filter ene cds nico abuelita 15 REPLACING THE RECORDING PAPER 36 Mains Filter enn 16 TROUBLE SEIOOTING citi pau ra sean 38 Myogram Filter rne iine nnn 17 Defining Lead Sequence amp Printout 18 ORDERING INFORMATION eeeeeneeen 39 EM A eee tae 19 TECHNICAL DATA al 40 Time Date ricino 20 Available Configurations eeee 44 P80Six Page 1 06 2001 Contents User Guide P80Six rI o 3 INTRODUCTION 2 reir tev oe ir Paese ces 2 SETTINGS FOR AUTOMATIC MODE se 21 2 Average Cycles 22 z OPERATION MODES ear eagle ame fi Measurements and Markings usssss 23 Automatic Mode rris 4 Interpretation cnc Manual Mode rri 5 Interpretation Settings LOCATION amp POWER sees 6 Selecting Rhythm Leads Loc tian PATIENT CABLE CONNECTIONS see 27 Power S pply saisie ct eoe e een ases 6 Standard Leads s s 29 BASIC INFORMATION ua oa i n T RECORDING AN ECG IN AUTOMATIC MODE 30 Switching On and Off seen 7
13. Full details of the interpretation option are given in the ECG Measurement and Interpretation booklet Page 24 P80Six 06 2001 Settings for Automatic Mode Interpretation Settings The Interpretation settings enable the user to determine whether or not certain comments will be added to the interpretation statements on the ECG printout Furthermore the patient s age can be defined lt or gt 30 and if low or high sensitivity should be applied Low sensitivity will suppress certain nonspecific ECG diagnosis this may be advisable when carrying out ECGs for screening Interpretation Settings Entry Key Sequence Setting Confirm 1 Normal abnormal is not printed 2 Normal abnormal is printed Unconfirmed report is not printed Unconfirmed report is printed Press STOP Patient age is assumed to be 30 Key SHIFT 6 Patient age is assumed to be 30 Low sensitivity o NI oO oO AJ O High sensitivity P80Six 06 2001 Page 25 Settings for Automatic Mode Interpretation Settings The Interpretation settings enable the user to determine whether or not certain comments will be added to the interpretation statements on the ECG printout Furthermore the patient s age can be defined lt or gt 30 and if low or high sensitivity should be applied Low sensitivity will suppress certain nonspecific ECG diagnosis this may be advisable
14. Italy Tel 39 055 4229 238 Fax 39 055 414 899 ESAOTE S p a Via di Caciolle 15 50127 Firenze Italy Tel 39 055 42291 Fax 39 055 4229 208 Internet Web Site http www esaote com Disclaimer The Information in this guide has been carefully checked for reliability however no guarantee is given as to the correctness of the contents and SCHILLER makes no representations or warranties regarding the contents of this manual We reserve the right to revise this document and make changes in the specification of the product described within at any time without obligation to notify any person of such revision or change Copyright Notice Copyright 1996 amp 1998 by SCHILLER AG All rights reserved You may not reproduce transmit transcribe store in a retrieval system or translate into any language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise any part of this publication without express written permission of SCHILLER AG Terms of Warranty The ESAOTE P80Six is warranted against defects in material and manufacture for the duration of one year as from date of purchase Excluded from this guarantee is damage caused by an accident or as a result of improper handling The warranty entitles free replacement of the defective part Any liability for subsequent damage is excluded The warranty is void if unauthorized or unqualified persons attempt to make repairs In case
15. Manual Mode Manual mode provides a direct printout of the real time ECG with full control of parameter selection The following can be freely chosen during or before the recording e Lead Group by means of the y and A keys The following lead groups are selectable 1 II HI aVR aVL aVF Cabrera aVL I aVR Il aVF III V1 V2 V3 V4 V5 V6 Il aVF Ill V2 V4 V5 V4 V5 V6 V7 V8 V9 Leads V7 V8 and V9 are only available when leads V1 V2 and V3 resp are moved to the corresponding positions Chart Speed by means of the i and E keys e Sensitivity by means of the and keys Filter see page 17 Page 32 P80Six 06 2001 Recording an ECG in Manual Mode MAN START To start the manual recording of a real time ECG press the key I o iS z ui The printout provides you with the following information The group of the six selected leads with lead identification On the lower edge chart speed sensitivity and filter settings if on are given At the top the heart rate as current average of 4 beats is shown 1mV To re centre the ECG traces press the key during operation STOP Finish the recording by pressing the key WARNING AFTER HEAVY ARTEFACTS OR LEAD OFF THE INDICATION OF THE HEART RATE MAY NOT BE RELIABLE P80Six Page 33 06 2001 Recording an ECG in Manual Mode MAN START To start the manual recording of a real time ECG pr
16. Potential Equalisation eere 7 RECORDING AN ECG IN MANUAL MODE 32 KEYBOARD 5 usa OE RERO e e ratios 8 CARE amp MAINTENANCE eene f P p dec MM INDICATORS voten diat benc de RR 9 po a a d oM AD GENERAL SETTINGS ccoo 10 12 Monthly Check Detaulls aut ta 11 Cleaning the Print Head LANJUAQE atc a Ta ea 14 REPLACING THE RECORDING PAPER 36 Baseline Filter oa eremi 15 DIETS EMail ge ia 16 TROUBLE SHOOTING wie snide 38 Myogram Filter nnne itte nnn 17 Defining Lead Sequence amp Printout mom 18 ORDERING INFORMATION 0 0 c cceeeeeeteeeeeeeeeeeeeeeee 39 Acoustic QRS Indication sse 19 TECHNICAL DATA eese tentnnents 40 Time Date sssssssseeeeeeennennnes 20 Available Configurations eese 44 P80Six Page 1 06 2001 Introduction MAINS AND POTENTIAL EQUALISATION CONNECTORS PAPER RELEASE CATCH PATIENT CABLE CONNECTOR LEAD INDICATORS POWER INDICATORS SYSTEM INDICATORS Page 2 P80Six 06 2001 Introduction MAINS AND POTENTIAL EQUALISATION CONNECTORS PATIENT CABLE CONNECTOR LEAD INDICATORS POWER INDICATORS SYSTEM INDICATORS Page 2 P80Six 06 2001 Introduction The P80Six is a 12 channel ECG recorder All ECG signals are simultaneously p
17. leads Sampling frequency 1000 Hz Digital resolution 5 uv Dynamic range 10 mVAC Max electrode potential 300 mVDC Time constant 3 28 Frequency response 0 05 to 150 Hz 3 dB Input impedance gt 10 MQ Myogram Filter muscle tremor filter 25 Hz or 35 Hz programmable not active on averaged waveform The stored ECGs can be printed with or without filter Line Frequency Filter Distortion free suppression of superimposed 50 or 60 Hz sinusoidal interferences by means of an adaptive digital filter Patient Input Fully floating and isolated defibrillation protected Patient Leakage Current 5 uA Page 42 P80Six 06 2001 Technical Data ECG Amplifier Simultaneous synchronous registration of all 9 active electrode signals 12 standard leads Sampling frequency 1000 Hz Digital resolution 5 uv Dynamic range 10 mVAC Max electrode potential 300 mVDC Time constant 3 28 Frequency response 0 05 to 150 Hz 3 dB Input impedance gt 10 MQ Myogram Filter muscle tremor filter 25 Hz or 35 Hz programmable not active on averaged waveform The stored ECGs can be printed with or without filter Line Frequency Filter Distortion free suppression of superimposed 50 or 60 Hz sinusoidal interferences by means of an adaptive digital filter Patient Input Fully floating and isolated defibrillation protected Patient Leakage Current l
18. m Measurements and Markings Interpretation Option only Entry Key Sequence Output Format Confirm Detailed table of measurement results is omitted 5 However the values of electrical axes intervals and heart rate are not suppressed 1 6 Detailed table of measurement results is printed Press SHIFT or 3 STOP 2 7 Reference markings beginning and end of P wave and Key QRS as well as end of T wave are omitted 8 Reference markings beginning and end of P wave and QRS as well as end of T wave are added to ECG cycles Confirm the selection by pressing STOP P80Six Page 23 06 2001 Settings for Automatic Mode Interpretation Option To print or suppress interpretation statements on the printout proceed as follows Interpretation Entry Key Sequence Output Format Confirm 1 5 Interpretation is omitted Press SHIFT or 4 STOP 2 6 Interpretation is printed Key Confirm the selection by pressing STOP Full details of the interpretation option are given in the ECG Measurement and Interpretation booklet Page 24 P80Six 06 2001 Settings for Automatic Mode Interpretation Option To print or suppress interpretation statements on the printout proceed as follows Interpretation Entry Key Sequence Output Format Confirm 1 5 Interpretation is omitted Press SHIFT or 4 STOP 2 6 Interpretation is printed Key Confirm the selection by pressing STOP
19. manual mode only V1 v2 V3 o Indicator lamp for selected lead group Standard in manual V4 V5 V6 mode only IH aVF Ii O Indicator lamp for selected lead group in manual mode only V2 V4 V5 V4 V5 V6 O Indicator lamp for selected lead group in manual mode only V7 V8 V9 P80Six Page 9 06 2001 Indicators Oo Mains indicator lit when mains connected o E5 Battery lamp lit when running on battery power mains not connected blinking when battery capacity is limited o A INOP Warning lamp for loose electrode connection or poor electrode contact o 2 PAPER Warning lamp for end of paper or paper jam O X FILTER Myogram filter lit when filter ON T Il o Indicator lamp for selected lead group Standard aVR aVL aVF Cabrera aVL l aVR Il aVF III in manual mode only V1 v2 V3 o Indicator lamp for selected lead group Standard in manual V4 V5 V6 mode only II aVF Ii O Indicator lamp for selected lead group in manual mode only V2 V4 V5 V4 V5 V6 O Indicator lamp for selected lead group in manual mode only V7 V8 V9 P80Six Page 9 06 2001 I E 9 z ui I o Rr 9 z ii General Settings Each parameter is set by means of acode This code comprises a combination starting with the SHIFT key followed by a number of keys and is always confirmed with the STOP key As soon as the SHIFT key is pressed the keyboard is dedicated to the programming function The setting is remembered and the keyboard is only released for ot
20. of a defect contact your dealer or the manufacturer The manufacturer can only be held responsible for the safety reliability and performance of the apparatus if e assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by him and the P80Six and approved attached equipment are used in accordance with the manufacturers instructions THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH EXTEND BEYOND THE WARRANTIES HEREINABOVE SET FORTH ESAOTE MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCT OR PARTS THEREOF About this Handbook The philosophy of the manufacturer is one of continuous improvement Our aim is to provide the user with the most up to date information and the latest technological developments Your suggestions and comments are welcome on all ESAOTE documentation Please contact the ESAOTE Cardiology Corporate Marketing Department Disclaimer The Information in this guide has been carefully checked for reliability however no guarantee is given as to the correctness of the contents and SCHILLER makes no representations or warranties regarding the contents of this manual We reserve the right to revise this document and make changes in the specification of the product described within at any time without obligation to notify any person of such revision or change Copyright Notice Copyright 1996 amp 1998 by SCHI
21. when the unit is switched on When the filter is active the FILTER lamp on the unit is lit Myogram Filter Entry Key Sequence Setting Confirm 2 Myogram Filter 25 Hz 3 Myogram Filter 35 Hz Press SHIFT 8 4 Myo Filt ON when switching on unit STOP marked on printout with Key 8 Myo Filt OFF when switching on unit marked on printout with Confirm the selection by pressing STOP An ECG recorded in auto mode is stored unfiltered Itis therefore possible to print the stored ECG either with or without passing the myogram filter P80Six Page 17 06 2001 General Settings Defining Lead Sequence amp Printout The required settings can be selected as follows Sequences amp Print Entry Key Sequence Definition Confirm 1 Standard Lead Sequence 2 Cabrera Lead Sequence 3 Simultaneous Print Press SHIFT 7 STOP 4 Sequential Print Key 5 Auto Centering ON 6 Auto Centering OFF Confirm the selection by pressing STOP The selectable lead groups for the P80Six are Lead Groups Standard Cabrera l V1 ll VA avL V1 Il V4 ll V2 aVF V5 l V2 aVF V5 ll V3 Hi V6 aVR V3 Ill V6 aVR V4 V2 V7 Il VA V2 V7 avL V5 VA V8 aVF V5 V4 V8 aVF V6 V5 V9 Ill V6 V5 V9 Leads V7 V8 and V9 are only available when leads V1 V2 and V3 resp are moved to the corresponding positions manual
22. 02 DIN ENISO 9001 2000 DIN EN 46001 1996 Gl 010341505001 Annex II Section 3 of the Directive 93 42 EEC Medical Devices Valid date 02 2004 CE 0123 Baar Switzerland 21 03 2001 KM ur SL Markus B tler Quality Assurance Manager Donde Obtener Servicio y Asesoramiento Comcercial Onde obter Assist ncia T cnica e de Vendas USA Russia Italy All other Countries BIOSOUND Inc 8000 Castleway Drive PO Box 50858 Inianapolis Indiana 46250 0858 Tel 1 317 849 1793 Fax 1 317 841 8616 ESAOTE S p a Moscow Representative Office Khlebniy per 27 121063 Moscow Russia Tel 7 095 232 1833 Fax 7 095 232 0205 ESAOTE S p a Via di Caciolle 15 50127 Firenze Italy Tel 39 055 4229 238 Fax 439055414 899 ESAOTE S p a Via di Caciolle 15 50127 Firenze Italy Tel 39 055 4229 1 Fax 39 055 4229 208 Internet Web Site http www esaote com Where to Obtain Service and Sales Advice Donde Obtener Servicio y Asesoramiento Comcercial Onde obter Assist ncia T cnica e de Vendas USA Russia Italy All other Countries BIOSOUND Inc 8000 Castleway Drive PO Box 50858 Inianapolis Indiana 46250 0858 Tel 1 317 849 1793 Fax 1 317 841 8616 ESAOTE S p a Moscow Representative Office Khlebniy per 27 121063 Moscow Russia Tel 7 095 232 1833 Fax 7 095 232 0205 ESAOTE S p a Via di Caciolle 15 50127 Firenze
23. 1 Operation Modes Manual Mode I o E 9 z ul Manual Mode provides a real time printout of 6 leads that are selected and indicated on the keyboard The following can be freely selected before or during recording Lead Group Chart Speed Sensitivity Myogram Filter For further information see paragraph ECG Recording in Manual Mode P80Six Page 5 06 2001 Operation Modes Manual Mode I o Rr 9 z ii Manual Mode provides a real time printout of 6 leads that are selected and indicated on the keyboard The following can be freely selected before or during recording Lead Group Chart Speed Sensitivity Myogram Filter For further information see paragraph ECG Recording in Manual Mode P80Six Page 5 06 2001 Location amp Power Location Do not keep or operate the apparatus in a wet moist or dusty environment Also avoid exposure to direct sunlight or heat from other sources Do not allow the unit to come into contact with acidic vapours or liquids as such contact may cause irreparable damage The unit should not be placed near X ray or diathermy units large transformers or motors The unit must be placed on a flat surface The unit should not be operated in areas where there is any danger of explosion Power Supply The unit can either be operated from the built in rechargeable battery or from the mains The mains connection is on t
24. 19 06 2001 General Settings I The selectable printout forms are z gt Simultaneous All ECG leads are printed in the same time segment in W automatic mode only Sequential Each group is a contiguous time segment of approximately 2 5 or 5 seconds in automatic mode only Auto Centering ON All ECG traces are centred dynamically for optimal use of paper width Auto Centering OFF ECG traces are set to a fixed baseline position and may possibly overlap Acoustic QRS Indication QRS BEEP The acoustic QRS indication can be switched on or off at any time by pressing the key P80Six Page 19 06 2001 General Settings Time Date CHANGE TIME DATE Time SHIFT 9 1 1 HHMMSS beep Date SHIFT 9 2 2 DDMMYY beep Wintertime to Summertime 1 Hr SHIFT 9 4 4 Summertime to Wintertime 1 Hr SHIFT 9 5 5 Page 20 P80Six 06 2001 General Settings Time Date CHANGE TIME DATE Time SHIFT 9 1 1 HHMMSS beep Date SHIFT 9 2 2 DDMMYY beep Wintertime to Summertime 1 Hr SHIFT 9 4 4 Summertime to Wintertime 1 Hr SHIFT 9 5 5 Page 20 P80Six 06 2001 Settings for Automatic Mode Two separate formats for the automatic ECG output can be selected as follows o d Automatic ECG Format 9 W pii Key Setup Format Sequence 1 Setup Format 1 SHIFT 2 Setup Format 2
25. 5 7 1998 b 11 2000 c 6 2001 Associated Documents Guide to the Interpretation and Measurement Program E D Article Number 9740440008 Distributed by ESAOTE S P A Via Di Caciolle 15 50127 Firenze Italy TEL 39 0 55 42291 FAX 39 0 55 4229 208 Manufactured by SCHILLERAG Altgasse 68 CH 6340 Baar Switzerland 93 42 EEC Medical Devices CE 0123 0123 Notified Body T V P 8 SAG 2 510286 c DECLARATION OF CONFORMITY Electrocardiograph ESAOTE P 80 Six We the undersigned hereby declare that the medical device class II a specified above conforms with the Essential Requirements listed in Annex I of EC Directive 93 42 EEC This declaration is supported by TUV Product Service GmbH Management Service D 80339 Munich Certificate of approval No Q1Z 01 0341505 002 DIN ENISO 9001 2000 DIN EN 46001 1996 G1 010341505001 Annex II Section 3 of the Directive 93 42 EEC Medical Devices Valid date 02 2004 CE 0123 Baar Switzerland 21 03 2001 KM er EAS Markus B tler Quality Assurance Manager DECLARATION OF CONFORMITY Electrocardiograph ESAOTE P 80 Six We the undersigned hereby declare that the medical device class II a specified above conforms with the Essential Requirements listed in Annex I of EC Directive 93 42 EEC This declaration is supported by TUV Product Service GmbH Management Service D 80339 Munich Certificate of approval No Q1Z 01 0341505 0
26. 50 mm s 2 Rhy 25 mm s The average complexes are printed out in four groups of three leads with 2 rhythm leads at a chart speed of 50 mm s 2 6 50 mm s 2 Rhy 25 mm s The average complexes are printed out in two groups of six leads with two rhythm leads at a chart speed of 50 mm s Press STOP Key Confirm the selection by pressing STOP Note Lead selection for the 2 rhythm leads is defined on page 26 Page 22 P80Six 06 2001 Settings for Automatic Mode lt 4 Measurements and Markings a O To define the measurements and markings proceed as follows Z Measurements and Markings Interpretation Option only Entry Key Sequence Output Format Confirm Detailed table of measurement results is omitted 5 However the values of electrical axes intervals and heart rate are not suppressed 1 6 Detailed table of measurement results is printed Press SHIFT or 3 STOP 2 7 Reference markings beginning and end of P wave and Key QRS as well as end of T wave are omitted 8 Reference markings beginning and end of P wave and QRS as well as end of T wave are added to ECG cycles Confirm the selection by pressing STOP P80Six Page 23 06 2001 Settings for Automatic Mode lt o Measurements and Markings d To define the measurements and markings proceed as follows
27. 50 mm s Confirm the selection by pressing STOP Note Lead selection for the rhythm lead is defined on page 26 P80Six Page 21 06 2001 Settings for Automatic Mode Average Cycles The Average cycles are defined as follows Average Cycles Interpretation Option only Entry Key Sequence Output Format Confirm No average cycles are printed 4 3 25 mm s 2 Rhy 25 mm s The average complexes are printed out in four groups of three leads with 2 rhythm leads at a chart speed of 25 mm s SHIFT or 2 4 8 50 mm s 2 Rhy 25 mm s The average complexes are printed out in four groups of three leads with 2 rhythm leads at a chart speed of 50 mm s 2 6 50 mm s 2 Rhy 25 mm s The average complexes are printed out in two groups of six leads with two rhythm leads at a chart speed of 50 mm s Press STOP Key Confirm the selection by pressing STOP Note Lead selection for the 2 rhythm leads is defined on page 26 Page 22 Settings for Automatic Mode P80Six 06 2001 Average Cycles The Average cycles are defined as follows Average Cycles Interpretation Option only Entry Key Sequence Output Format Confirm No average cycles are printed 4 8 25 mm s 2 Rhy 25 mm s The average complexes are printed out in four groups of three leads with 2 rhythm leads at a chart speed of 25 mm s SHIFT or 2 4 8
28. 6 2001 Replacing the Recording Paper e Place fingers under the retaining bar and pull directly upwards The paper tray cover releases e Withdraw the cover from the unit DO NOT FORCE THE PAPER TRAY COVER RUNS FREELY OVER THE DEDICATED RUNNERS e Remove any remaining paper from the paper tray e Place a new paper pack into the paper tray with the printed grid side facing upwards e Place the beginning of the paper over the black paper roller on the paper tray cover XY Return the paper tray cover in position and press firmly until secure e Press the STOP key to transportthe paper tothe lt start position c7 ESAOTE canonly guarantee perfect printouts when ESAOTE original chart paper or chart paper of the same quality is used P80Six 06 2001 Replacing the Recording Paper Page 37 e Place fingers under the retaining bar and pull directly upwards The paper tray cover releases e Withdraw the cover from the unit DO NOT FORCE THE PAPER TRAY COVER RUNS FREELY OVER THE DEDICATED RUNNERS Remove any remaining paperfromthe papertray e Place a new paper pack into the paper tray with the printed grid side facing upwards e Place the beginning of the paper over the black paper roller on the paper tray cover N N Return the paper tray N cover in position and press firmly until secure e Press the STOP key to transportthe paper to th
29. HECK ELECTRODE CONTACT As much as possible ensure Noisy traces that patient is relaxed and warm Activate myogram filter to reduce y d muscle tremor Check mains filter to 50 or 60 Hz according to local power supply ECG trace wanders away from Baseline drift check electrode contact Press 1mV key to reset centre baseline Select a higher baseline frequency Poor quality printout ECG Thermal print head dirty clean printhead with alcohol Possible f i faulty printhead contact local service centre Ensure that the traces breaking up S paper tray cover is clicked into place Connect unit to the mains supply Ensure that the paper tray cover No printout MUN is clicked into place Check paper level Page 38 P80Six 06 2001 Ordering Information Your local representative stocks all the disposables and accessories available for the P80Six In case of difficulty or to obtain the address of your local dealer please contact the head office Our staff will be pleased to help process your order or to provide any details for all ESAOTE products Complete Units P80Six Basic 230 V Complete with standard accessories ssseeeeees 9840400110 P80Six Interpretation 230 V Complete with standard accessories sssssse 9840400120 Standard Accessories Patient cable EURO colours pack of paper set of ten electrodes ECG gel User Guide P80Six Basic 115 V Complete with standard accessorie
30. ION UNITS SHOULD ONLY BE USED AT A SUFFICIENT DISTANCE FROM THE ELECTRODES IN CASE OF DOUBT THE PATIENT SHOULD BE DISCONNECTED FROM THE RECORDER THIS UNIT IS CF CLASSIFIED ACCORDING TO IEC 601 1 THIS MEANS THAT THE PATIENT CONNECTION IS FULLY ISOLATED AND DEFIBRILLATION PROTECTED THE MANUFACTURER CAN ONLY GUARANTEE PROTECTION AGAINST DEFIBRILLATION VOLTAGE HOWEVER WHEN THE ORIGINAL ESAOTE PATIENT CABLE IS USED IF SEVERAL UNITS ARE COUPLED THERE IS A DANGER OF SUMMATION OF LEAKAGE CURRENT DO NOT TOUCH THE CASING DURING DEFIBRILLATION IF THE PATIENT CABLE SHOULD BECOME DEFECTIVE AFTER DEFIBRILLATION LEAD OFF WILL BE DISPLAYED AND AN ACOUSTIC ALARM GIVEN Contents User Guide P80Six rI o 3 INTRODUCTION irita e inaa Rei 2 SETTINGS FOR AUTOMATIC MODE 2 z OPERATION MODES 4 Average Cycles seeecennnnnn 22 E Automatic Mode 4 Measurements and Markings sud CRIA Interpretation sss 24 Manual ida 5 Interpretation Settings seee 25 LOCATION amp POWER iie bri eere ees 6 Selecting Rhythm Leads sssssssssss 26 ee A PATIENT CABLE CONNECTIONS 27 Vs enn D DM MED standard Leads rte Rene 29 BASIC INFORMATION c cccccceceeeeeeeeeeeeeeeeeeeeeeeeeaeeeeees Switching On and Off RECORDING AN ECG IN AUTOMATIC MODE 30 Potential
31. IONS AND ELECTRICAL INTERFERENCE HOWEVER SPECIAL CARE MUST BE EXERCISED WHEN THE UNIT IS USED WITH HIGH FREQUENCY EQUIPMENT IT MUST BE ENSURED THAT NEITHER THE PATIENT NOR THE ELECTRODES INCLUDING THE NEUTRAL ELECTRODE COME INTO CONTACT WITH OTHER PERSONS OR CONDUCTING OBJECTS EVEN IF THESE ARE EARTHED THERE IS NO DANGER WHEN USING THE ECG UNIT FOR A PACEMAKER PATIENT OR WITH SIMULTANEOUS USE OF OTHER ELECTRICAL STIMULATION EQUIPMENT HOWEVER THE STIMULATION UNITS SHOULD ONLY BE USED AT A SUFFICIENT DISTANCE FROM THE ELECTRODES IN CASE OF DOUBT THE PATIENT SHOULD BE DISCONNECTED FROM THE RECORDER THIS UNIT IS CF CLASSIFIED ACCORDING TO IEC 601 1 THIS MEANS THAT THE PATIENT CONNECTION IS FULLY ISOLATED AND DEFIBRILLATION PROTECTED THE MANUFACTURER CAN ONLY GUARANTEE PROTECTION AGAINST DEFIBRILLATION VOLTAGE HOWEVER WHEN THE ORIGINAL ESAOTE PATIENT CABLE IS USED IF SEVERAL UNITS ARE COUPLED THERE IS A DANGER OF SUMMATION OF LEAKAGE CURRENT DO NOT TOUCH THE CASING DURING DEFIBRILLATION IF THE PATIENT CABLE SHOULD BECOME DEFECTIVE AFTER DEFIBRILLATION LEAD OFF WILL BE DISPLAYED AND AN ACOUSTIC ALARM GIVEN Safety Notices TO PREVENT ELECTRIC SHOCK DO NOT DISASSEMBLE THE UNIT NO SERVICEABLE PARTS INSIDE REFER SERVICING TO QUALIFIED PERSONNEL ONLY DO NOT USE THIS UNIT IN AREAS WHERE THERE IS ANY DANGER OF EXPLOSION OR THE PRESENCE OF FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS
32. LLER AG All rights reserved You may not reproduce transmit transcribe store in a retrieval system or translate into any language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise any part of this publication without express written permission of SCHILLER AG Terms of Warranty The ESAOTE P80Six is warranted against defects in material and manufacture for the duration of one year as from date of purchase Excluded from this guarantee is damage caused by an accident or as a result of improper handling The warranty entitles free replacement of the defective part Any liability for subsequent damage is excluded The warranty is void if unauthorized or unqualified persons attempt to make repairs In case of a defect contact your dealer or the manufacturer The manufacturer can only be held responsible for the safety reliability and performance of the apparatus if s assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by him and the P80Six and approved attached equipment are used in accordance with the manufacturers instructions THERE ARE NO EXPRESS OR IMPLIED WARRANTIES WHICH EXTEND BEYOND THE WARRANTIES HEREINABOVE SET FORTH ESAOTE MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCT OR PARTS THEREOF About this Handbook The philosophy of the manufacturer is one of con
33. O OBTAIN EXPERT OPINION ON THE RESULTS AND TO INSTITUTE CORRECT TREATMENT IF INDICATED FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Safety Notices TO PREVENT ELECTRIC SHOCK DO NOT DISASSEMBLE THE UNIT NO SERVICEABLE PARTS INSIDE REFER SERVICING TO QUALIFIED PERSONNEL ONLY DO NOT USE THIS UNIT IN AREAS WHERE THERE IS ANY DANGER OF EXPLOSION OR THE PRESENCE OF FLAMMABLE GASES SUCH AS ANAESTHETIC AGENTS IN THE EVENT OF ACCIDENTAL LCD BREAKAGE AND RESULTANT LEAKAGE OF FLUID DO NOT INHALE INGEST OR MAKE CONTACT WITH THE SKIN IF CONTACT IS MADE RINSE IMMEDIATELY THIS PRODUCT IS NOT DESIGNED FOR STERILE USE THIS PRODUCT IS NOT DESIGNED FOR OUTDOOR USE SWITCH THE UNIT OFF BEFORE CLEANING AND DISCONNECT FROM THE MAINS DO NOT UNDER ANY CIRCUMSTANCES IMMERSE THE UNIT OR CABLE ASSEMBLIES IN LIQUID THE DEVICE MUST ONLY BE OPERATED USING BATTERY POWER IF THE EARTH CONNECTION IS SUSPECT OR IF THE MAINS LEAD IS DAMAGED OR SUSPECTED OF BEING DAMAGED DO NOT USE HIGH TEMPERATURE STERILISATION PROCESSES SUCH AS AUTOCLAVING DO NOT USE E BEAM OR GAMMA RADIATION STERILISATION DO NOT USE SOLVENT CLEANERS USE ONLY ACCESSORIES AND OTHER PARTS RECOMMENDED OR SUPPLIED BY ESAOTE USE OF OTHER THAN RECOMMENDED OR SUPPLIED PARTS MAY RESULT IN INJURY INACCURATE INFORMATION AND OR DAMAGE TO THE UNIT THE PS0SIX COMPLIES WITH EMC REGULATIONS FOR MEDICAL PRODUCTS WHICH AFFORDS PROTECTION AGAINST EMISS
34. Pa Control Panel Rubber keys Technical data subject to change without notice P80Six 06 2001 Page 43 I o iS z ul I o Rr 9 z ii Technical Data Available Configurations The P80Six is available in two versions Standard Version Unit with ECG recording and printout capabilities Version C Unit with additional ECG Interpretation program including measurements Page 44 P80Six 06 2001 Technical Data Available Configurations The P80Six is available in two versions Standard Version Unit with ECG recording and printout capabilities Version C Unit with additional ECG Interpretation program including measurements Page 44 P80Six 06 2001
35. Page 8 P80Six 06 2001 Keyboard ON QRS BEEP Switch unit on Cancel or enable QRS beeper OFF e AUTO GAIN O Switch unit off mv e Automatic ECG sensitivity adjustmentfrom Em 10to5 mm mV in order to avoid overlapping Le Copy stored ECG traces in automatic mode only va A Da Start automatic recording me ECG sensitivity selector b 10 or 20 mm Oa Bun mV manual recording only art manual recording Stop recording move paper to start position Chart speed selector 5 25 or 50 mm s TER manual recording only ex 1mV Switch myogram filter muscle tremor filter on or off Lead group selector forward Lead group selector backward Key for 1 mV indication mark on output during manual recording Use this key also for baseline recentering SHIFT Key for initiation of setups and selection of second format for printout Page 8 P80Six 06 2001 Indicators or o N INOP o 2 PAPER O FILTER Mains indicator lit when mains connected Battery lamp lit when running on battery power mains not connected blinking when battery capacity is limited Warning lamp for loose electrode connection or poor electrode contact Warning lamp for end of paper or paper jam Myogram filter lit when filter ON Indicator lamp for selected lead group Standard IH aVR aVL aVF 9 Cabrera aVL I aVR Il aVF III in
36. SECA Ct6i User Manual P80 Siz 12 Channel Electrocardiograph User Guide English Electrocardi grafo de 12 Canales Guia para el Usuario Espa ol Electrocardi grafo de 12 Canais Manual do Utilizador Portugu s ESAOTE ESAOTE S PA Via Di Caciolle 15 50127 Firenze Italy Tel 39 0 55 4229 1 Fax 439 0 55 4229 208 Internet Web Site http www esaote com P80 Siz 12 Channel Electrocardiograph User Guide English Electrocardi grafo de 12 Canales Gu a para el Usuario Espa ol Electrocardi grafo de 12 Canais Manual do Utilizador Portugu s ESAOTE ESAOTE S PA Via Di Caciolle 15 50127 Firenze Italy Tel 39 0 55 4229 1 Fax 39 0 55 4229 208 Internet Web Site http www esaote com P80Six User Guide English Guia para el Usuario del P80Six Espa ol Manual do Utilizador de P80Six Portugu s Article Number 9740440015 7 1998 b 11 2000 c 6 2001 Associated Documents Guide to the Interpretation and Measurement Program E D Article Number 9740440008 Distributed by ESAOTE S P A Via Di Caciolle 15 50127 Firenze Italy TEL 39 0 55 4229 1 FAX 39 0 55 4229 208 Manufactured by SCHILLERAG Altgasse 68 CH 6340 Baar Switzerland 93 42 EEC Medical Devices CE 0123 ON it 0123 Notified Body TUV P 8 SAG 2 510286 c P80Six User Guide English Gu a para el Usuario del P80Six Espa iol Manual do Utilizador de P80Six Portugu s Article Number 974044001
37. The 2 rhythm leads are defined as follows The rhythm leads are printed out as defined Two separate rhythm leads can be selected The following formats can be set Extremity Leads Precordial Leads Entry Key Sequence Lead Confirm Entry Key Sequence Lead Confirm 1 l 1 vi 2 Il 2 v2 3 3 I Press 3 3 V3 Press SHIFT or 8 STOP SHIFT or 9 STOP 4 4 aVR Key 4 4 V4 Key 5 aVL 5 V5 6 aVF 6 V6 Confirm the selection by pressing STOP Page 26 P80Six 06 2001 Patient Cable Connections The accessory kit of the electrocardiograph includes a 10 lead patient cable This cable is plugged into the patient cable socket on the right hand side of the unit and secured with the two screws The P80Six is CF rated The patient connection is fully isolated and defibrillation protected Protection against defibrillation voltage is however only ensured if the original ESAOTE patient cable Part no 9740410001 USA 9740410002 is used Make sure that during ECG recording neither the patient nor the conducting parts of the patient connection or the electrodes including the neutral electrode come into contact with other persons or conducting objects even if these are earthed P80Six 06 2001 Patient Cable Connections Page 27 The accessory kit of the electrocardiograph includes a 10 lead patient cable This cable is plugged into the patient c
38. able socket on the right hand side of the unit and secured with the two screws The P80Six is CF rated The patient connection is fully isolated and defibrillation protected Protection against defibrillation voltage is however only ensured if the original ESAOTE patient cable Part no 9740410001 USA 9740410002 is used Make sure that during ECG recording neither the patient nor the conducting parts of the patient connection or the electrodes including the neutral electrode come into contact with other persons or conducting objects even if these are earthed P80Six 06 2001 Page 27 I o iS z ui I o Rr 9 z ii Patient Cable Connections The quality of the ECG is dependent on the preparation and the resistance between the skin and the electrode To ensure a good quality ECG and minimise the skin electrode resistance remember the following points ll Ensure that the patient is warm and relaxed 2 Shave electrode area before cleaning 3 Thoroughly clean the area with alcohol 4 Place the C4 electrode first in the fifth intercostal space on midclavicular line Then place C1 in fourth intercostal space at the right sternal border C2 in fourth intercostal space at the left sternal border C3 between and equidistant to C4 and C2 C6 on left midaxillary line on the same level as C4 C5 between and equidistant to CA and C6 Following these simple guidelines will ensure good results ev
39. and the patient cable is not connected Potential Equalisation If the P80Six is used in conjunction with other patient connected equipment we recommend that the potential equalisation stud xy on the rear of the unit is connected to the hospital building common ground with the yellow green ground cable When working from an emergency vehicle the vehicle common ground can be used P80Six 06 2001 Page 7 I o iS z ul I o Rr 9 z ii Keyboard ON OFF o COPY AUTO START oe MAN START or FILTER D gt lt Switch unit on Switch unit off Copy stored ECG Start automatic recording Start manual recording Stop recording move paper to start position Switch myogram filter muscle tremor filter on or off Lead group selector forward Lead group selector backward QRS BEEP Cancel or enable QRS beeper AUTO GAIN mm mV Automatic ECG sensitivity adjustment from 10to5 mm mV in order to avoid overlapping traces in automatic mode only LA Im HUI ECG sensitivity selector b 10 or 20 mm mV manual recording only ESE ES Chart speed selector 5 25 or 50 mm s manual recording only Key for 1 mV indication mark on output during manual recording Use this key also for baseline recentering SHIFT Key for initiation of setups and selection of second format for printout
40. battery operation When the battery capacity is limited the indicator flashes To recharge the battery connect the apparatus to the mains supply by means of the supplied power cable A totally discharged battery needs less than 15 hours to be fully recharged 60 in less than 3 hours 90 in less than 7 hours A fully charged battery lasts approximately 6 hours of normal use The unit can remain connected to the mains supply without any danger of damage to either the battery or the unit Page 6 P80Six 06 2001 Basic Information Switching On and Off OFF ON The P80Six is switched on by means of the on key and off by means of the off L key The unit is switched off after 5 minutes 30 seconds if battery capacity is limited if no key is pressed and the patient cable is not connected Potential Equalisation If the P80Six is used in conjunction with other patient connected equipment we recommend that the potential equalisation stud xy on the rear of the unit is connected to the hospital building common ground with the yellow green ground cable When working from an emergency vehicle the vehicle common ground can be used P80Six 06 2001 Basic Information Page 7 Switching On and Off ON OFF The P80Six is switched on by means of the on key and off by means of the off key The unit is switched off after 5 minutes 30 seconds if battery capacity is limited if no key is pressed
41. d quality thermal printer e Built in rechargeable battery for mains independent use Simple one key operation e Automatic or manual recording modes Selectable printing formats e ECG memory for easy copying Interpretation program option including measurements P80Six Page 3 06 2001 I o iS z ul I o Rr 9 z ii Operation Modes Automatic Mode Automatic Mode provides a printout giving 10 seconds of ECG recording of all 12 leads in 2 different formats The following can be programmed freely in each of the formats before recording e Lead Format e Chart Speed e With the optional interpretation program installed it is also possible to select the measurement table average cycles with optional markings and interpretation statements for the printout For further information see paragraph Settings for Automatic Mode P80Six Page 4 06 2001 Operation Modes Automatic Mode Automatic Mode provides a printout giving 10 seconds of ECG recording of all 12 leads in 2 different formats The following can be programmed freely in each of the formats before recording e Lead Format e Chart Speed e With the optional interpretation program installed it is also possible to select the measurement table average cycles with optional markings and interpretation statements for the printout For further information see paragraph Settings for Automatic Mode Page 4 P80Six 06 200
42. e start position ESAOTE can only guarantee perfect printouts when ESAOTE original chart paper or chart paper of the same quality is used P80Six 06 2001 Page 37 I o iS z ui I o iS z iwi Trouble Shooting Problem What to Check Unit does not switch On Mains Indicator Lamp is not lit Check if mains cable is plugged in Call your local ESAOTE dealer if problem is still present Noisy traces CHECK ELECTRODE CONTACT As much as possible ensure that patient is relaxed and warm Activate myogram filter to reduce muscle tremor Check mains filter to 50 or 60 Hz according to local power supply ECG trace wanders away from centre Baseline drift check electrode contact Press 1mV key to reset baseline Select a higher baseline frequency Poor quality printout ECG traces breaking up Thermal print head dirty clean printhead with alcohol Possible faulty printhead contact local service centre Ensure that the paper tray cover is clicked into place Connect unit to the mains supply Ensure that the paper tray cover No pantout is clicked into place Check paper level Page 38 P80Six 06 2001 Trouble Shooting Problem What to Check Unit does not switch On Mains Check if mains cable is plugged in Indicator Lamp is not lit Call your local ESAOTE dealer if problem is still present C
43. ery time Page 28 P80Six 06 2001 Patient Cable Connections The quality of the ECG is dependent on the preparation and the resistance between the skin and the electrode To ensure a good quality ECG and minimise the skin electrode resistance remember the following points f Ensure that the patient is warm and relaxed 2 Shave electrode area before cleaning 3 Thoroughly clean the area with alcohol 4 Place the C4 electrode first in the fifth intercostal space on midclavicular line Then place C1 in fourth intercostal space at the right sternal border e C2 in fourth intercostal space at the left sternal border C3 between and equidistant to C4 and C2 C6 on left midaxillary line on the same level as C4 C5 between and equidistant to C4 and C6 Following these simple guidelines will ensure good results every time Page 28 P80Six 06 2001 Patient Cable Connections Standard Leads z 9 zZ W C3 GREEN C4 BROWN C1 RED C6 VIOLET IEC AHA N Black RL Green C5 BLACK CE VEDLOW R Red RA White RIGHT ARM RED LEFT ARM YELLOW C1 White Red V1 Brown Red C2 White Yellow v2 Brown Yellow C3 White Green V3 Brown Green C4 White Brown V4 Brown Blue C5 White Black V5 Brown Orange C6 White Violet V6 Brown Violet L Yellow LA Black F Green LL Red RIGHT LEG BLACK LEFT LEG
44. es are described in detail STOP NOTE THAT THE SETTINGS ARE ALWAYS CONFIRMED BY PRESSING THE KEY Page 10 P80Six 06 2001 General Settings Defaults Default Settings Setting P80Six P80Six with Interpretation Option Language English English Leads Standard S Standard S ECG 25 mm s short 0 MECG 2 x 6 50 mm s 2 Format 1 ECG 25mm s short 0 Measurements suppressed Marks enabled Interpretation enabled ECG 25 mm s long 000 MECG none Format 2 ECG 25 mm s long 000 Measurements disabled Marks enabled Interpretation disabled Rhythm Leads V1 ECG V1 II MECG V1 ECG V1 Il MECG Autom Centering Enabled Enabled Printout of Signals Sequential Sequential Baseline Filter Setting 0 05 Hz 0 05 Hz Mains Filter Setting 50 Hz USA 60Hz 50 Hz USA 60Hz Myogram Filter Setting 35 Hz OFF 35 Hz OFF Interpretation Settings N A U A30 S P80Six Page 11 06 2001 General Settings Defaults Default Settings Setting P80Six P80Six with Interpretation Option Language English English Leads Standard S Standard S ECG 25 mm s short 0 MECG 2 x 6 50 mm s 2 Format 1 ECG 25mm s short 0 Measurements suppressed Marks enabled Interpretation enabled ECG 25 mm s long
45. ess the key I o Rr 9 z ii The printout provides you with the following information The group of the six selected leads with lead identification On the lower edge chart speed sensitivity and filter settings if on are given At the top the heart rate as current average of 4 beats is shown 1mV To re centre the ECG traces press the key during operation STOP Finish the recording by pressing the key WARNING AFTER HEAVY ARTEFACTS OR LEAD OFF THE INDICATION OF THE HEART RATE MAY NOT BE RELIABLE P80Six Page 33 06 2001 Care amp Maintenance Care of your P80Six The patient cable should not be exposed to excessive mechanical stress Whenever disconnect ing the leads hold the plugs and not the cables Align the leads in such a way as to prevent anyone stumbling over them or any damage caused by the wheels of instrument trolleys The cable can be wiped with soapy water Sterilization if required should be done with gas only and not with steam To disinfect wipe the cable with any standard hospital disinfectant The casing of the P80Six should be cleaned with a soft cloth on the surface only DISCONNECT THE UNIT BEFORE CLEANING DO NOT UNDERANY CIRCUMSTANCES IMMERSE THE APPARATUS INTO A CLEANING LIQUID OR STERILIZE WITH HOT WATER STEAM OR AIR Self test Initiate a self test of the P80Six as follows Initiate Self Test Entry Key Sequence Action SHIFT 0 3 3 Pr
46. ff will be pleased to help process your order or to provide any details for all ESAOTE products Complete Units P80Six Basic 230 V Complete with standard accessories cccceseseeeeeesseeeeeeeesteeeeeees 9840400110 P80Six Interpretation 230 V Complete with standard accessories ssssssse 9840400120 Standard Accessories Patient cable EURO colours pack of paper set of ten electrodes ECG gel User Guide P80Six Basic 115 V Complete with standard accessories oocconoocccccnncoccnnononancnnnonarnnononnns 98404001 1 1 P80Six Interpretation 115 V Complete with standard accessories sssssse 9840400121 Standard Accessories Patient cable USA colours pack of paper set of ten electrodes ECG gel User Guide Accessories 10 lead Patient Cable Euro oooooococooonononononcnononononononononononononononorononoronnnnonononononononononononos 9740410001 10 lead Patient Cable USA ssessseseseeeeeeeeeeeeeeeeneeneennnnrnnn nennen enne eren ener 9740410002 4 Extremity clamp electrodes ec cccceseseeeeseeceeeeeeneeeeseeceeesenseneeneeseeeeseeeeenseseenenenateesaees 9610020000 4 Extremity clamp electrodes USA colour ssessseeneeeenen enn 9610020001 16 Suction electrodes ient id ba 9610054000 ECG electrode cream 100 ml ssssssssssseeeeeeeeneeeneeen nennen nnne 9210091133 Recording Paper Z folded 1 Pack
47. he rear of the unit The mains indicator lamp is always lit when the unit is connected to the mains supply A battery indicator lamp confirms battery operation When the battery capacity is limited the indicator flashes To recharge the battery connect the apparatus to the mains supply by means of the supplied power cable A totally discharged battery needs less than 15 hours to be fully recharged 60 in less than 3 hours 90 in less than 7 hours A fully charged battery lasts approximately 6 hours of normal use The unit can remain connected to the mains supply without any danger of damage to either the battery or the unit Page 6 Location amp Power P80Six 06 2001 Location Do not keep or operate the apparatus in a wet moist or dusty environment Also avoid exposure to direct sunlight or heat from other sources Do not allow the unit to come into contact with acidic vapours or liquids as such contact may cause irreparable damage The unit should not be placed near X ray or diathermy units large transformers or motors The unit must be placed on a flat surface The unit should not be operated in areas where there is any danger of explosion Power Supply The unit can either be operated from the built in rechargeable battery or from the mains The mains connection is on the rear of the unit The mains indicator lamp is always lit when the unit is connected to the mains supply A battery indicator lamp confirms
48. her functions when the STOP key is pressed Once the settings have been confirmed they are stored in the memory even when the unit is switched off As an example if you want to set the language on your P80Six to English proceed as follows SHIFT SHIFT STOP MAW TT Key 0 Key 2 Key 2 Program sequence Start programming Switch to numerical keyboard CONFIRM SETTING On the following pages the programmable parameters and the programming sequences are described in detail STOP NOTE THAT THE SETTINGS ARE ALWAYS CONFIRMED BY PRESSING THE KEY Page 10 P80Six 06 2001 General Settings Each parameter is set by means of a code This code comprises a combination starting with the SHIFT key followed by a number of keys and is always confirmed with the STOP key As soon as the SHIFT key is pressed the keyboard is dedicated to the programming function The setting is remembered and the keyboard is only released for other functions when the STOP key is pressed Once the settings have been confirmed they are stored in the memory even when the unit is switched off As an example if you want to set the language on your P80Six to English proceed as follows SHIFT SHIFT STOP 2 Wwe LT Key 0 Key 2 Key 2 Program sequence Start programming Switch to numerical keyboard CONFIRM SETTING On the following pages the programmable parameters and the programming sequenc
49. intout of Self test A table giving information for the service staff is printed out Page 34 P80Six 06 2001 Care amp Maintenance Care of your P80Six The patient cable should not be exposed to excessive mechanical stress Whenever disconnect ing the leads hold the plugs and not the cables Align the leads in such a way as to prevent anyone stumbling over them or any damage caused by the wheels of instrument trolleys The cable can be wiped with soapy water Sterilization if required should be done with gas only and not with steam To disinfect wipe the cable with any standard hospital disinfectant The casing of the P80Six should be cleaned with a soft cloth on the surface only DISCONNECT THE UNIT BEFORE CLEANING DO NOT UNDERANY CIRCUMSTANCES IMMERSE THE APPARATUS INTO A CLEANING LIQUID OR STERILIZE WITH HOT WATER STEAM OR AIR Self test Initiate a self test of the P80Six as follows Initiate Self Test Entry Key Sequence Action SHIFT 0 3 3 Printout of Self test A table giving information for the service staff is printed out Page 34 P80Six 06 2001 Care amp Maintenance 12 Monthly Check The unit should undergo a technical safety check every 12 months This safety check should extend to include the following e Visual inspection of the unit and cables Electrical safety tests according to IEC 601 1 and IEC 601 2 25
50. llows Mains Filter Entry Key Sequence Filter Setting Confirm 5 Mains Filter 50 Hz Press SHIFT 6 Mains Filter 60 Hz STOP A Key 9 Mains Filter off Page 16 P80Six 06 2001 General Settings Myogram Filter I o E 9 z ui The Myogram filter suppresses disturbances caused by strong muscle tremor The cutoff frequency of the myogram filter is set to 25 or 35 Hz The myogram filter is switched on and off manually with the FILTER key Switching on or off can also be programmed as default when the unit is switched on When the filter is active the FILTER lamp on the unit is lit Myogram Filter Entry Key Sequence Setting Confirm 2 Myogram Filter 25 Hz 3 Myogram Filter 35 Hz Press SHIFT 8 4 Myo Filt ON when switching on unit STOP marked on printout with Key 8 Myo Filt OFF when switching on unit marked on printout with Confirm the selection by pressing STOP An ECG recorded in auto mode is stored unfiltered Itis therefore possible to print the stored ECG either with or without passing the myogram filter P80Six Page 17 06 2001 General Settings Myogram Filter I o iS z ii The Myogram filter suppresses disturbances caused by strong muscle tremor The cutoff frequency of the myogram filter is set to 25 or 35 Hz The myogram filter is switched on and off manually with the FILTER key Switching on or off can also be programmed as default
51. ows Select Language Entry Key Sequence Language Confirm 1 German 2 English 3 French 4 Swedish Press SHIFT 0 2 5 American STOP Key 6 Italian 7 Spanish 8 Portuguese 9 Russian Confirm the selection by pressing STOP Notes Once selected the language remains active However when the unit is reset to the default settings the default language will be English Page 14 P80Six 06 2001 General Settings There are three different filters which can be set individually as follows Baseline filter Mains filter Myogram filter The setting for each filter is given on the setup printout Baseline Filter The digital Baseline filter suppresses excessive baseline drifts The setting options are as follows Baseline Filter Entry Key Sequence Filter Setting Confirm 0 0 05 Hz Default Pross SHIFT 5 1 0 15 Hz STOP Ke 3 0 30Hz y The set value is the lower limit of the frequency range and is normally set to 0 05 Hz The settings 0 15 and 0 30 Hz should only be used when absolutely necessary as the possibility exists that they could affect the original ECG signal especially the ST segments Confirm the selection by pressing STOP P80Six 06 2001 General Settings Page 15 There are three different filters which can be set individually as follows e Baseline filter Mains filter Myogram filter The setting for each filter is given on the setup printout Ba
52. recording of all leads in either Standard or Cabrera format according to selection T Sensitivity i Heart Rate Speed Filter Settings Patient Data field to manually insert patient data and if set Average Cycles Interpretation option only Intervals Interpretation option only Axis Interpretation option only Sokolow Index ECG index for hypertrophy Interpretation option only Detailed Measurement Table Interpretation option only Interpretation Interpretation option only COPY To obtain an extra printout of the ECG recording in Format 1 simply press SHIFT COPY To obtain an extra printout of the second format press 2 followed by P80Six Page 31 06 2001 Recording an ECG in Manual Mode Manual mode provides a direct printout of the real time ECG with full control of parameter selection The following can be freely chosen during or before the recording e Lead Group by means of the y TA keys The following lead groups are selectable 1 IL Hl aVR aVL aVF Cabrera aVL I aVR Il aVF III V1 V2 V3 V4 V5 V6 Il aVF Ill V2 V4 V5 V4 V5 V6 V7 V8 V9 Leads V7 V8 and V9 are only available when leads V1 V2 and V3 resp are moved to the corresponding positions Chart Speed by means of the and keys Sensitivity by means of the i and keys Filter see page 17 Page 32 P80Six 06 2001 Recording an ECG in
53. requirements as detailed previously AUTO GAIN When the key is pressed before recording in automatic mode the unit detects very large waveform amplitudes and sets the sensitivity for the extremity and or precordial leads to 5 mm mV to reduce the overlapping of traces AUTO START To start the automatic ECG recording in Format 1 simply press s SHIFT AUTO START To start the automatic recording in the second format press followed by Page 30 P80Six 06 2001 Recording an ECG in Automatic Mode x The printout provides you with the following information 2 l o ECG recording of all leads in either Standard or Cabrera format according to selection T Sensitivity Heart Rate Speed Filter Settings Patient Data field to manually insert patient data and if set Average Cycles Interpretation option only Intervals Interpretation option only Axis Interpretation option only Sokolow Index ECG index for hypertrophy Interpretation option only Detailed Measurement Table Interpretation option only Interpretation Interpretation option only COPY To obtain an extra printout of the ECG recording in Format 1 simply press SHIFT COPY To obtain an extra printout of the second format press followed by P80Six Page 31 06 2001 Recording an ECG in Automatic Mode x The printout provides you with the following information z i9 ECG
54. rocessed to provide instant ECG recordings Two automatic recording modes can be individually preset to enable one button ECG recording of preferred print formats Individual lamps are provided to give power paper error filter lead group and lead off indications In addition any detected disturbance i e loose electrode or end of paper gives an audible alarm and the corresponding indicator lamp flashes The P80Six includes the following features Low weight and compact dimensions Large A4 size printout from integrated quality thermal printer e Built in rechargeable battery for mains independent use Simple one key operation e Automatic or manual recording modes Selectable printing formats ECG memory for easy copying Interpretation program option including measurements P80Six Page 3 06 2001 Introduction The P80Six is a 12 channel ECG recorder All ECG signals are simultaneously processed to provide instant ECG recordings Two automatic recording modes can be individually preset to enable one button ECG recording of preferred print formats Individual lamps are provided to give power paper error filter lead group and lead off indications In addition any detected disturbance i e loose electrode or end of paper gives an audible alarm and the corresponding indicator lamp flashes The P80Six includes the following features Low weight and compact dimensions Large A4 size printout from integrate
55. s sssseeeeeeee 98404001 11 P80Six Interpretation 115 V Complete with standard accessories ssssssse 9840400121 Standard Accessories Patient cable USA colours pack of paper set of ten electrodes ECG gel User Guide Accessories 10 lead Patient Cable Euro oooooccccocononononononononononononononononononononoro nono ron nono nono nnn nnne n enne nnn 9740410001 O lead Patient Cable USA 5 1 ertet soe Ie tet ee sedaan aiia ra sta tool o rnai ges 9740410002 4Extremity clamp electrodes oococconcccinnnncccnnnoncncnnnnrecnnnnenennnne rene nennen nnne nnne 9610020000 4 Extremity clamp electrodes USA colour eesssseeneeneeneneen 9610020001 G SUCTION SIOCIIODES sieren levees devin ae i e aiaia gidi oari haaie 9610054000 ECG electrode cream 100 M kesisi ernie eaae a 9210091133 Recording Paper Z folded 1 Pack enne 9690029100 AO To be defined Uu U u 9704250100 Patient Cable Holder etie cte rri ei it te alain 9101341000 User Guide lh F staat 9740440011 UserGuide GBE Pruna ii dt 9740440015 P80Six Page 39 06 2001 Ordering Information Your local representative stocks all the disposables and accessories available for the P80Six In case of difficulty or to obtain the address of your local dealer please contact the head office Our sta
56. seline Filter The digital Baseline filter suppresses excessive baseline drifts The setting options are as follows Baseline Filter Entry Key Sequence Filter Setting Confirm 0 0 05 Hz Default Pr ss SHIFT 5 1 0 15 Hz STOP Ke 3 0 30Hz The set value is the lower limit of the frequency range and is normally set to 0 05 Hz The settings 0 15 and 0 30 Hz should only be used when absolutely necessary as the possibility exists that they could affect the original ECG signal especially the ST segments Confirm the selection by pressing STOP P80Six 06 2001 Page 15 I o iS z ul I o Rr 9 z ii General Settings Mains Filter The Mains filter is an adaptive digital interference filter designed to suppress AC interference without attenuating or distorting the ECG Set the mains filter in accordance with the frequency of your local mains supply as follows Mains Filter Entry Key Sequence Filter Setting Confirm 5 Mains Filter 50 Hz Press SHIFT 6 Mains Filter 60 Hz STOP E Key 9 Mains Filter off Page 16 P80Six 06 2001 General Settings Mains Filter The Mains filter is an adaptive digital interference filter designed to suppress AC interference without attenuating or distorting the ECG Set the mains filter in accordance with the frequency of your local mains supply as fo
57. t 5 uA Page 42 P80Six 06 2001 Technical Data Safety Standard CF according to IEC and complying with the following RL 93 42 EEC EN 60601 1 1990 IEC 601 1 IEC 601 2 25 1993 pr EN 1441 1994 EMC CISPR 111 1985 EN 55011 1992 IEC 801 2 1991 IEC 801 3 1984 IEC 801 4 1988 IEC 801 5 Safety Class according to IEC 601 1 with internal power supply lla according to RL 93 42 EEC CE 0123 Environmental Conditions Temperature Operating 10 to 40 C Temperature Storage 10 to 50 C Relative humidity 25 to 95 non condensing Atmospheric pressure 700 to 1060 hPa Control Panel Rubber keys Technical data subject to change without notice P80Six 06 2001 Technical Data Page 43 Safety Standard CF according to IEC and complying with the following RL 93 42 EEC EN 60601 1 1990 IEC 601 1 IEC 601 2 25 1993 pr EN 1441 1994 EMC CISPR 111 1985 EN 55011 1992 IEC 801 2 1991 IEC 801 3 1984 IEC 801 4 1988 IEC 801 5 Safety Class according to IEC 601 1 with internal power supply lla according to RL 93 42 EEC CE 0123 Environmental Conditions Temperature Operating 10 to 40 C Temperature Storage 10 to 50 C Relative humidity 25 to 95 non condensing Atmospheric pressure 700 to 1060 h
58. tinuous improvement Our aim is to provide the user with the most up to date information and the latest technological developments Your suggestions and comments are welcome on all ESAOTE documentation Please contact the ESAOTE Cardiology Corporate Marketing Department PHYSICIAN S RESPONSIBILITY THE P80SIX ELECTROCARDIOGRAPH IS PROVIDED FOR THE EXCLUSIVE USE OF QUALIFIED PHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION THE NUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BE EXAMINED WITH RESPECT TO THE PATIENTS OVERALL CLINICAL CONDITION THE RECORDING PREPARATION QUALITY AND THE GENERAL RECORDED DATA QUALITY WHICH COULD EFFECT THE REPORT DATA ACCURACY MUST ALSO BE TAKEN INTO ACCOUNT IT IS THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS OR TO OBTAIN EXPERT OPINION ON THE RESULTS AND TO INSTITUTE CORRECT TREATMENT IF INDICATED FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN PHYSICIAN S RESPONSIBILITY THE P80SIX ELECTROCARDIOGRAPH IS PROVIDED FOR THE EXCLUSIVE USE OF QUALIFIED PHYSICIANS OR PERSONNEL UNDER THEIR DIRECT SUPERVISION THE NUMERICAL AND GRAPHICAL RESULTS FROM A RECORDING MUST BE EXAMINED WITH RESPECT TO THE PATIENTS OVERALL CLINICAL CONDITION THE RECORDING PREPARATION QUALITY AND THE GENERAL RECORDED DATA QUALITY WHICH COULD EFFECT THE REPORT DATA ACCURACY MUST ALSO BE TAKEN INTO ACCOUNT IT IS THE PHYSICIANS RESPONSIBILITY TO MAKE THE DIAGNOSIS OR T
59. when carrying out ECGs for screening Interpretation Settings Entry Key Sequence Setting Confirm 1 Normal abnormal is not printed 2 Normal abnormal is printed Unconfirmed report is not printed Unconfirmed report is printed Press STOP Patient age is assumed to be 30 Key SHIFT 6 Patient age is assumed to be 30 Low sensitivity o NI OD a A Q High sensitivity P80Six 06 2001 Page 25 I E 9 z ul I o Rr 9 z ii Settings for Automatic Mode Selecting Rhythm Leads Rhythm Leads Entry key Setup Lead Sequence 3 Setup Rhythm Lead 1 SHIFT 4 Setup Rhythm Lead 2 The 2 rhythm leads are defined as follows The rhythm leads are printed out as defined Two separate rhythm leads can be selected The following formats can be set Extremity Leads Precordial Leads Entry Key Sequence Lead Confirm Entry Key Sequence Lead Confirm 1 l 1 vi 2 Il 2 v2 3 3 I Press 3 3 v3 Press SHIFT or 8 STOP SHIFT or 9 STOP 4 4 aVR Key 4 4 V4 Key 5 aVL 5 V5 6 aVF 6 V6 Confirm the selection by pressing STOP Page 26 P80Six 06 2001 Settings for Automatic Mode Selecting Rhythm Leads Rhythm Leads ey Rey Setup Lead Sequence 3 Setup Rhythm Lead 1 SHIFT 4 Setup Rhythm Lead 2

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