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SAFETV INFORMATION

1. Amendment User Manual corpuls Version 1 4 Alarm message notification Explanation measure The temperature of the generator has exceeded a limit value due to a high amount of discharges Allow the system to cool down in rest periods f the error persists contact sales and service partners Check modules f there is no connection between the monitoring unit and the patient box and or the defibrillator pacer at the time of switch off or if there is a timing problem between the modules this is communicated to the user by a message on the display In this case disconnect the the modules and check if all modules are switched off If this is not so switch off the respective modules via the On Off key Check therapy electrodes The therapy electrodes are not connected correctly to the therapy master cable Check the connection of the plugs and adjust if necessary If the message persists contact sales and service partners Circuit open check pacer electrodes The corPatch electrodes are not connected correctly to the patient or have a too high resistance to the skin of the patient A stimulation is not possible Check if the electrodes are dried out or expired and if they are applied correctly to the patient Code changed Confirmation that the access code has been successfully changed Code mismatch retry The verification of the new access code did not m
2. Avoid too frequent internal discharges Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 1 of 10 Amendment User Manual corpuls3 Version 1 5 Error GSM module The GSM module is probably faulty Contact sales and service partners Error SpO2 mod ule Error CO2 module Error temp mod Error IBP module The module mentioned is faulty Contact sales and service partners Module restarts Alarm message shown on the display of the patient box The patient box restarts due to a software error No ECG cable The corpuls is in AED mode with connected shock paddles and the 4 pole ECG monitoring cable is not connected to the patient box Connect the 4 pole ECG monitoring cable No ECG cable PACER The pacer is stimulating but there is no 4 pole ECG monitoring cable connected or individual ECG electrodes are loose Check if the 4 pole ECG monitoring cable is connected correctly to the patient box Check ECG electrodes Make sure that all contact clips are connected correctly to the electrodes and or all ECG electrodes are correctly placed on the patient s skin No GSM PIN configured The PIN belonging to the SIM card has not been configured No SIM card present Insert a SIM card and configure the PIN Paddle interface error The corpuls is not functioning correctly and must not be used Contact sales and service partners
3. Replace battery defib Replace battery monitor Replace battery P Box The corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Self test failed Self test failed P Box The corpuls is possibly not functioning correctly and may no longer be used Contact sales and service partners SYND CLK error Defib SYND CLK error P box Automatic synchronisation in manual defibrillation mode does not work No shock can be delivered Contact sales and service partners Temperature measurement failed Temperature measurement could not be performed correctly Check temperature sensor and its correct placement on the patient Test resistor temperatur high Resistor temp high P Box Defibrillation was performed on the test contacts too frequently in succession Avoid further defibrillations on the test contacts Therapy electrodes loose Check the correct placement of the corPatch electrodes on the patient Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 2 of 10 Amendment User Manual corpuls3 Version 1 5 Time Date inv P Box Alarm message shown on the display of the patient box The configured time or the date is invalid Set the correct time date Time Date invalid The configured time or the date is invalid Set the correct time date Table 10 21 Amendme
4. Contact sales and service partners The pacer is stimulating but there is no connection between the monitoring unit and the defibrillator pacer The wireless communication between the patient box and the monitoring unit defibrillator has been interrupted or could not be established Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the wireless connection If necessary use the corpuls as compact device Communication between the patient box and the monitoring unit defibrillator has been interrupted or could not be established Check if one of the two infrared interfaces is covered or dirty CO2 apnoea CO2 apnoea P Box An apnoea has been detected Check respiration Confirm alarms After the user has acknowledged the alarm messages contained in the following alarm list and has taken corresponding measures on the patient those can be confirmed Defibrillator failure 4 The device is possibly not functioning correctly and must not be used Contact sales and service partners Defibrillator failure X Defib failure X P box The X stands for a failure number from 1 to 3 The corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Defibrillator temperature high Defib temp high P Box The defibrillator was very frequently charged within a short period
5. Kind regards GS Elektromedizinische Gerate G Stemple GmbH Managing Director Genera Manager R amp D Production Gesch ftsf hrer Geseh ftsf hrer F amp E Fertigung VP Product Management Leiter Produktmanagemen 40f7 pion Yon s ee cor SAFETY INFORMATION Technical Bulletin No 006 5 corpuls Annex A Illustration of the device combination corpuls 1 Monitoring unit 2 Patient box 3 Defibrillator asin Vere sa uiavocipsow Deren U s2v0c P 30W dm 24 Ao iM AR Rating plates with position of the serial numbers System Info 1 Monitoring Unit REL 1 6 0_C3_BD 2000000036760305 Patient box REL 1 6 0_C3_BD 07000000366AD 105 Defibrillator REL 1 6 0_C3_BD DA000000366ESA05 Info 1 System Info 2 Biphasic module M v2 00V S v2 00L 1K 996 v0 3 14 5 v0 3 14 6 LM3 390 SM V220 0829 V13 V7 v7 vafva vd MCSS 04 00 ECG Interpretation 18 24 03 Data Interface 0212 00 18 da 00 b4 bd Document name 14 Aligemein Technische Page 507 and location Bulietins TB_006_eng_0i coc translation date 12010 03 16 Release daie ALT 0 04 06 Translator name Corinna Gaubat z SAFETY INFORMATION Technical Bulletin No 006 cS corpuls Annex B Confirmation form Please mark with a cross ALL fields that apply to your company O We have read and understood the safety information of GS Elektromedizinische Ger te G Stemple GmbH
6. Pairing has to be performed again so that the modules can be used together Confirmation of the question if the pairing should be performed again is necessary Confirm in order to repeat pairing For further details see chapter 3 2 1 If pairing fails repeatedly the corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Pairing failed Software version conflict Connection authorisation Pairing has failed The required modules cannot be connected due to different software versions For further details see chapter 3 2 1 Contact sales and service partners Pairing successful The connection authorisation has been issued successfully The modules can be used together Perform CPR Perform cardio pulmonary resuscitation CPR Follow the instructions on the display Recording failed Check CF card Data recording is not possible Check if the CompactFlash card is inserted correctly Re enter new code NUMBER NUMBER NUMBER NUMBER User prompt to re enter the new access code Reset user code Confirmation prompt asking if the access code of the user level should be reset to factory settings Select Energy Sending fax page NUMBER Status indication during fax transmission The number of already sent pages is shown in brackets Sending fax Status indication during fax
7. in the following alarm list and has taken corresponding measures on the patient those can be confirmed Defib rillator failure X The X stands for a failure number from 1 to 3 The device is possibly not functioning correctly and must not be used Contact sales and service partners Defibrillator failure 4 The device is possibly not functioning correctly and must not be used Contact sales and service partners Defibrillator failure P Box The device is possibly not functioning correctly and must not be used Contact sales and service partners Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 1 of 11 Amendment User Manual corpuls Version 1 4 Alarm message Notification Explanation measure Defibrillator temperature high Defib temp high P Box The defibrillator was very frequently charged within a short period Avoid too frequent internal discharges ECG cable 4 pole loose 4 pole cable loose P Box Check if the 4 pole ECG cable is connected correctly to the patient box ECG cable 6 pole loose 6 pole cable loose P Box Check if the complementary 6 pole ECG diagnostic cable is connected correctly to the patient box ECG electrodes off More than one ECG electrode is not connected to the patient Check ECG electrodes EKG Kabel lose Check if the 4 pole ECG cable or the complementary 6 pole EC
8. DEFI The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device MAN BIM The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device PIF The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device PIF The corpuls is not functioning correctly and must not be used Contact sales and service partners Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 5 of 10 Amendment User Manual corpuls3 Version 1 6 Notification in the message line and information in the protocol Explanation measure Event recorded Confirmation that an event has been recorded Failure HES data transmission HES failure P box An error occurred during data transmission of the ECG measuring and interpretation software HES Data transmission was not successful Repeat procedure If the data transmission fails repeatedly contact sales and service partners Fax transfer failure An error has occurred during the fax transmission The fax has not been transferred Repeat fax transfer Fax transfer finished NUMBER page s sent Confirmation that the fax has been successfully transferred with the indicated amount of pages GSM error Connection not possible
9. Indication of the defibrillation mode used Shock not recommended The result of the ECG analysis indicates that a shock is not recommended Take measures as needed If necessary continue cardio pulmonary resuscitation Shock performed Defibrillation energy has been released Check vital signs and continue cardio pulmonary resuscitation if necessary Shock recommended Defibrillation is recommended Perform defibrillation immediately Short circuit Check electrodes The therapy electrodes have an electric connection short circuit Make sure that the therapy electrodes do not touch SIM card authorisation Status message of fax transmission Wait for authorisation of the SIM card in the mobile communications network Start ECG Starting time of the recorded ECG in the protocol Start new mission By confirming a new data record is created on the CF card Stop ECG Ending time of the recorded ECG in the protocol Switch off pacer System Power Down in NUMBER sec Count down indicating the remaining time until the system shuts down Unlock keyboard Confirmation prompt asking if the keyboard lock should be disengaged Table 10 22 Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 Amendment to notifications in the message line 10 of 10 Amendment User Manual corpuls Version 1 4 10 Procedur
10. SIM card locked Check SIM card Enter safety code for unlocking the SIM card see instructions of operating company e g Personal Unblocking Key PUK f the SIM card cannot be unlocked contact first the mobile communications operator and then the sales and service partners Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 6 of 10 Amendment User Manual corpuls3 Version 1 5 GSM error Wrong GSM PIN The personal identification number PIN entered is wrong Repeat High impedance IBP calibration failed INUMBER The electrical resistance of the patient impedance is to high for the selected settings An intensity for stimulation has been selected that cannot be reached with the impedance present To perform a pacer therapy adaequate for the patient a higher stimulation intensity must be selected Increase intensity Perform medical measures as needed Event in the protocol indicating that the calibration of the invasive pressure channel has failed Repeat calibration of the indicated pressure channel Initialising GSM modem Status indication during fax transmission Invalid Retry Keyboard locked Keyboard lock has been engaged Keyboard locked Keep key HOME pressed to unlock Keyboard unlocked Keyboard lock has been disengaged Line is busy The dialed fax line is busy Logging onto netw
11. again so that the modules can be used together Confirmation of the question if the pairing should be performed again is necessary Confirm in order to repeat pairing For further details see chapter 3 2 1 f pairing fails repeatedly the device is possibly not functioning correctly and must not be used Contact sales and service partners Pairing failed Software version conflict Connection authorisation Pairing has failed The required modules cannot be connected due to different software versions For further details see chapter 3 2 1 The device is not functioning correctly and must not be used Contact sales and service partners Pairing result Status message after connection authorisation Pairing in the protocol Pairing successful The connection authorisation has been issued successfully The modules can be used together Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 9 of 11 Amendment User Manual corpuls Version 1 4 Pause pacing Confirmation prompt asking if the stimulation should be interrupted Perform CPR Perform ventilation and cardiac massage cardio pulmonary resuscitation for as long as the device shows the message Perform CPR User prompt to switch off the device Power down After confirmation the device shuts down completely Power OFF Confirmation prompt asking if the system shold b
12. is charging DEMO Mode ON The DEMO mode is active Check if curves and parameters are displayed Dialing signal level NUMBER Dialing process of the fax option Display of the signal strength of reception Do not touch or move patient The ECG analysis is being performed Do not touch or move patient Follow the instructions on the display Enter code NUMBER NUMBER NUMBER NUMBER User prompt to enter the access code Enter new Code NUMBER NUMBER NUMBER NUMBER User prompt to enter a new access code Error in device BIM The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device DEFI The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device MAN BIM The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device PIF The corpuls is not functioning correctly and must not be used Contact sales and service partners Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 5 of 11 Amendment User Manual corpuls Version 1 4 Error in device PIF The corpuls is not functioning correctly and must not be used Contact sales and service partners Event recorded Confirmation that an event has been re
13. mode does not work No shock can be delivered Contact sales and service partners Temperature measurement failed Temperature measurement could not be performed correctly Check temperature sensor and its correct placement on the patient Test resistor temperatur high Resistor temp high P Box Defibrillation was performed on the test contacts too frequently in succession Avoid further defibrillations on the test contacts Table 10 21 Amendment to alarm messages and notifications 10 4 Amendment to Notifications and Information in the Protocol The notifications marked with do not require further explanation as they are self explanatory The measure to be taken is to follow the instruction given in the notification The following notification texts can be shown on the display or are printed out in the protocol in alphabetical order Due to translation the sequence of the alarm messages in English differs from that in German Alarm message notification Explanation measure activated AED Time stamp and status indication in the protocol that the defibrillator has been activated in AED mode activated MANUAL Time stamp and status indication in the protocol that the defibrillator has been activated in manual mode Charging not possible A technical error occurred Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 3 of 11
14. of 2010 04 06 O We have informed our users in an appropriate way about the contents of this safety information and the amendment to the user manual To be filled in by the customer please print Organisation Address Location Country Name First Name Mr Ms Title Fax Phone Company stamp E Mail Date Signature Please return this confirmation form until 2010 04 30 at the latest to GS Elektromedizinische Ger te G Stemple GmbH Hauswiesenstrasse 26 D 86916 Kaufering Fax 49 8191 65722 22 Document name U Aligemein Tecnnische Page 60f7 ra onen and localien Bulleiins TB_CO amp _eng_01 coc u u qo oe Goran tanslation date 2010 0316 Release daisy 2070 04 06 nu at QM Transletoi name Corinna Gaubaiz u Release name Klaus Stemple nt SAFETY INFORMATION Technical Bulletin No 006 c5 corpuls Annex C Authorised corpuls sales and service partners Please consult our homepage for international sales and service addresses www corpuls com Amendment User Manual corpuls3 10 Version 1 6 Procedure in Case of Malfunctions 10 3 Amendment to Alarm Messages The following alarm messages can be shown on the display in alphabetical order Due to translation the sequence of the alarm messages in English differs from that in German Alarm meldungmessage Explanation measuresErl uterung Ma nahme Alarm confir
15. transmission Connection to required number has been established Fax transmission is running Connection not possible The number selected with the fax option cannot be dialed f possible improve reception according to location Repeat procedure possibly at a later time Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 4 of 10 Amendment User Manual corpuls3 Version 1 5 D ECG NUMBER saved Event in the protocol indicating that a D ECG has been saved The number of the D ECG is shown in brackets D ECG fax sent Confirmation that the D ECG has been sent via fax D ECG recorded Confirmation that the D ECG has been fully displayed in the preview and saved Defibrillation only possible in manual defi mode User prompt to switch from AED mode to manual defibrillation mode The therapy electrodes used are not authorised for use in the AED mode Defibrillator activated TEXT Defibrillator analysis result gt gt gt Shock not recommended Defibrillator analysis result gt gt gt Shock recommended Event in the protocol indicating that the defibrillator mode has been activated Meaning of the parameter manual or AED Event in the protocol saving the result of the ECG analysis Event in the protocol saving the result of the ECG analysis Defibrillator deactivated Event in the protocol indicating that the def
16. unit patient box is interrupted or could not be established Make sure that the distance between the modules is no more than 10 m and that no obstacles impede the wireless No connection to defibrillator unit communication If needed use the corpuls as a compact device The communication between the connected modules defibrillator and monitoring unit patient box is interrupted or could not be established Check if one of the infrared interfaces is covered ooo iy The wireless communication between patient box and monitoring unit defibrillator is interrupted or could not be established Make sure that the distance between the modules is no more than 10 m and that no obstacles impede the wireless communication If needed No connection to P box use the corpuls as a compact device The communication between the connected modules patient box and monitoring unit defibrillator is interrupted or could not be established Check if one of the infrared interfaces is covered or dirty For operation of the pacer in DEMAND mode the 4 No ECG cable in DEMAND mode pole ECG monitoring cable has to be connected to the patient and to the corpuls For operating the SIM card in the GSM module it is No PIN available necessary to enter a 4 figure PIN in the configuration menu No SIM card zu A technical error occurred The temperature of the generator has exceeded a limit value Allow the system to cool down in rest per
17. 1 5 Charging not possible A technical error occurred The temperature of the generator has exceeded a limit value due to a high amount of discharges Allow the system to cool down in rest periods If the error persists contact sales and service partners Check modules If there is no connection between the monitoring unit and the patient box and or the defibrillator pacer at the time of switch off or if there is a timing problem between the modules this is communicated to the user by a message on the display In this case disconnect the the modules and check if all modules are switched off If this is not so switch off the respective modules via the On Off key Check therapy electrodes The therapy electrodes are not connected correctly to the therapy master cable Check the connection of the plugs and adjust if necessary If the message persists contact sales and service partners Code changed Confirmation that the access code has been successfully changed Code mismatch Retry The verification of the new access code did not match the earlier entry To repeat the process confirm the prompt and enter the access code again Configuration loaded Configuration reset Configuration stored Connect ECG cable Connect pacer cable User prompt to connect the therapy master cable to the therapy electrodes Connected Sending fax Status message during fax
18. G diagnostic cable is connected correctly to the patient box GSM module comm failure The GSM module is probably faulty Contact sales and service partners IBP calibration error The calibration of one pressure channel has failed because a higher pressure than atmospheric pressure was measured at one transducer Repeat calibration Module restarts Alarm message shown on the display of the patient box The patient box restarts due to a software error No defibrillation electrodes corPatch missing P box Connect corPatch electrodes or shock paddles to the therapy master cable of the corpuls No ECG cable The corpuls is in AED mode with connected shock paddles and the 4 pole ECG monitoring cable is not connected to the patient box Connect the 4 pole ECG monitoring cable No ECG cable PACER The pacer is stimulating but there is no 4 pole ECG cable connected or individual ECG electrodes are loose Check if the 4 pole ECG cable is connected correctly Check ECG electrodes Make sure that all contact clips are connected correctly to the electrodes and or all ECG electrodes are correctly placed on the patient s skin No GSM PIN entered The PIN belonging to the SIM card has not been configured or no SIM card is present Insert a SIM card and configure the PIN No pacer cable corPatch missing P box Connect the corPatch cable to the corpuls th
19. GSM error Line is busy Possibly a wrong fax number has been dialed Repeat dialing The dialed fax line is busy Try to establish the fax connection at a later point in time GSM error Lost modem control Switch off the corpuls and switch on again f the message text is displayed permanently contact sales and service partners GSM error Network not available Signal strength of reception is too low No connection can be established to the mobile communications network f possible improve reception according to location Repeat procedure possibly at a later time GSM error No SIM card Check SIM card Insert SIM card GSM error SIM card error Check SIM card Try re inserting SIM card f the error cannot be eliminated contact the mobile communications operator or the sales and service partners GSM error SIM card locked Check SIM card Enter safety code for unlocking the SIM card see instructions of operating company e g Personal Unblocking Key PUK f the SIM card cannot be unlocked contact first the mobile communications operator and then the sales and service partners Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 6 of 10 Amendment User Manual corpuls3 Version 1 6 GSM error Wrong GSM PIN The personal identification number PIN entered is wrong Repeat High impedance Th
20. SAFETY INFORMATION Technical Bulletin No 006 cS corpuls 5 Troubleshooting Conspicuous Devices If the message Pairing failed is shown repeat the pairing procedure If this does not remedy the problem check the infrared interfaces of the device for foreign bodies and start the pairing procedure again Please take notice that the monitoring unit and the patient box have to be paired first The pairing procedure is then repeated with the defibrillator unit and this module combination If the device shows the message Check modules when switching off separate the individual modules and check if all modules have been switched off correctly If this is not the case each module can be switched off correctly by keeping the green On Off key depressed for 3 seconds If this does not work the switch off can be forced by keeping the green On Off key depressed for 8 seconds and thus interrupting the power supply of the module However a forced switch off may result in data loss on the CF card 6 Immediate measures Please inform all users in your organisation once again about e The correct procedure when integrating new modules in the device combination e possible errors that can occur doing so and how to remedy them e the importance of the message Check modules when switching off the corpuls and e the necessity to check the modules for correct switch off if the message was displayed For further improvement and to assist th
21. SAFETY INFORMATION Technical Bulletin No 006 eh corpuls GS Elektromedizinische Ger te G Stemple GmbH Hauswiesenstra e 26 D 86916 Kaufering Tel 49 8191 65722 0 Fax 49 8191 65722 22 info corpuls com www corpuls com No Targel audience Date Number 0 pages 006 All users En 2010 04 06 7 Atfecied pmduets Seria numbers Lot identitication Software Firmware corpuls User Manual Pertaining to software version 1 4 0 1 5 0 und 1 6 0 Dear Siror Madam we would like to inform you via this letter about an amendment to the user manual of the corpuls defibrillator monitoring system This letter will contain information on e the reason for the amendment and on possible consequences e the measures you have to take as user of the device to reduce implications of the problem This applies to user manuals pertaining to the software versions 1 4 0 1 5 0 and 1 6 0 of the corpuls series independent of the configuration of the devices Please find the amendment as a separate annex to this letter or on our homepage Please read this customer information carefully and return the filled in and signed confirmation letter Annex B to GS until 2010 04 30 at the latest end locetion translation dale 12010 3 7 ransietor name Corinna Gaubatz ay i is SAFETY INFORMATION Technical Bulletin No 006 5 corpuls 1 Error description There has been one reported case
22. SIM card Insert SIM card GSM error SIM card error Check SIM card Try re inserting SIM card f the error cannot be eliminated contact the mobile communications operator or the sales and service partners Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 6 of 11 Amendment User Manual corpuls Version 1 4 GSM error SIM card locked Check SIM card Enter safety code for unlocking the SIM card see instructions of operating company e g Personal Unblocking Key PUk f the SIM card cannot be unlocked contact first the mobile communications operator and then the sales and service partners GSM error Wrong GSM PIN High impedance The personal identification number PIN entered is wrong Repeat The electrical resistance of the patient impedance is to high for the selected settings An intensity for stimulation has been selected that cannot be reached with the impedance present To perform a pacer therapy adaequate for the patient a higher stimulation intensity must be selected Increase intensity Perform medical measures as needed IBP calibration failed Event in the protocol indicating that calibration of the invasive pressure channel has failed Repeat calibration of the indicated pressure channel Impedance high Make sure that the corPatch electrodes have full contact with the patient s skin In case of exce
23. atch the earlier entry To repeat the process confirm the prompt and enter the access code again Configuration loaded Configuration reset Configuration stored Connect ECG cable Connect pacer cable User prompt to connect the therapy master cable to the therapy electrodes Connect therapy electrodes Check the connecting plug of the therapy master cable If necessary connect the therapy electrodes with the connecting plug Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 4 of 11 Amendment User Manual corpuls Version 1 4 Connected Sending fax Status message during fax transmission Connection to required number has been established Fax transmission is running Connection not possible The number selected with the fax option cannot be dialed Improve reception Repeat procedure possibly at a later time Continue pacing Confirmation prompt asking if the stimulation should be continued D ECG fax sent Confirmation that the D ECG has been sent via fax Defibrillation only possible in manual defi mode User prompt to switch from AED to manual defibrillation mode The therapy electrodes used are not authorised for AED mode Defibrillator analysis result gt gt gt TEXT Event in the protocol saving the result of the ECG analysis Defibrillator is charging Notification that the defibrillator
24. corded Event recorded NUMBER wav Event in the protocol that an event has been recorded There is a voice recording pertaining to the respective event Failure HES data transmission HES failure An error has occurred during data transmission of the ECG measuring and interpretation software HES Data transmission was not successful Repeat procedure f the data transmission fails repeatedly contact sales and service partners FAX transfer failure An error has occurred during the fax transmission The fax has not been transferred Repeat fax transfer Fax transfer finished INUMBER page s sent Confirmation that the fax has been successfully transferred with the indicated amount of pages GSM error Connection not possible Possibly a wrong fax number has been dialed Repeat dialing GSM error Line is busy The dialed fax line is busy Try to establish the fax connection at a later point in time GSM error Lost modem control Switch off the corpuls and switch on again f the message text is displayed permanently contact sales and service partners GSM error Network not available Signal strength of reception is too low No connection can be established to the mobile communications network f possible improve reception according to location Repeat procedure possibly at a later time GSM error No SIM card Check
25. e l shut down Ready for shock Message that the corpuls is ready to deliver a shock in defibrillation mode Recording failed Check CF card Re enter new Code NUMBER NUMBER NUMBER NUMBER Data recording is not possible Check if the CompactFlash card is inserted correctly User prompt to re enter the new access code Reset user code Confirmation prompt asking if the access code of the user level should be reset to factory settings Select Energy Select frequency Select intensity Select intensity frequency Select mode User prompt to select the pacer mode Sending fax page NUMBER Status indication during fax transmission The number of already sent pages is shown in brackets Sending fax Status indication during fax transmission Shock NUMBER J NUMBER J NUMBER Ohm s Time stamp and status indication of a performed defibrillation in the protocol The selected energy the effectively released energy in brackets and the impedance in Ohm are indicated Indication of the defibrillation mode used Shock aborted The shock could not be delivered If necessary repeat shock release Shock not recommended The result of the ECG analysis indicates that a shock is not recommended Take measures as needed If necessary continue cardio pulmonary resuscitation Shock performed Defibrillation ener
26. e electrical resistance of the patient impedance is to high for the selected settings An intensity for stimulation has been selected that cannot be reached with the impedance present To perform a pacer therapy adaequate for the patient a higher stimulation intensity must be selected Increase intensity Perform medical measures as needed IBP calibration failed Event in the protocol indicating that the calibration of the invasive pressure channel has failed Repeat calibration of the indicated pressure channel Initialising GSM modem Status indication during fax transmission Invalid Retry Keyboard locked Keyboard locked Keep key HOME pressed to unlock Keyboard lock has been engaged Keyboard unlocked Keyboard lock has been disengaged Logging onto network Mission end Status message of fax transmission The GSM module is logging onto the mobile communications network Event in the protocol indicating the ending time of the device mission Mission start Event in the protocol indicating the starting time of the device mission New code invalid Retry User prompt to re enter the new access code if the repetition was wrong New module Start pairing Two modules have been connected that do not have a connection authorisation Pairing Confirm if these modules are to receive a connection authorisation and the existing connection autho
27. e in Case of Malfunctions 10 3 Amendment to Alarm Messages The following alarm messages can be shown on the display in alphabetical order Due to translation the sequence of the alarm messages in English differs from that in German Alarm message Notification Explanation measure Alarm suspension NUMBER s The alarm suspension is activated The count down shows the remaining time in seconds until the alarm suspension ends automatically Biphasic module selftest error Defib selftest error P Box The device is possibly not functioning correctly and must not be used Contact sales and service partners Check pacer The pacer is stimulating but there is no connection between the monitoring unit and the defibrillator pacer The wireless communication between the patient box and the monitoring unit defibrillator has been interrupted or could not be established Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the wireless connection If necessary use the corpuls as compact device Communication between the patient box and the monitoring unit defibrillator has been interrupted or could not be established Check if one of the two infrared interfaces is covered or dirty CO2 apnoea CO2 apnoea P Box An apnoea has been detected Check respiration Confirm alarms After the user has acknowledged the alarm messages contained
28. e user the short manual should be carried along with the device 7 Corrective Measures of the Manufacturer Complementing the user manual in chapter 10 Procedure in Case of Malfunctions with the missing alarm messages their meaning and possible corrective measures to be taken Please file this amendment into your user manual version 1 4 0 1 5 0 and 1 6 0 8 Deadline Briefing the users should be effected immediately by appropriate measures e g via e mail or by posting this letter and the user manual amendment at the bulletin board Please return the filled in confirmation letter Annex B to GS until 2010 04 30 at the latest We thank you for your understanding for the realisation of these corrective measures and apologise for the inconveniences For further questions please contact your authorised corpuls sales and service partner see also annex C or www corpuls com Document name Us Allgermein echinische j Page 307 o Re I ane tocetion BulelinsiTB_DUG_eng Ucoz Release daie 2010 04 08 QM Sal aA 2 u yaen Release name Klaus Stemale CAA WKanslallon date 2910 Trangisiar name Con SAFETY INFORMATION Technical Bulletin No 006 5 corpuls Contact person of the manufacturer for questions Dipl Ing FH Axel Bischoff VP Product Management Leiter Produktmanagement Tel 49 0 81 91657 220 Fax 49 0 81 91 6 57 22 22 E Mail md vigilance corpuls com
29. ectly and must not be used Contact sales and service partners Defibrillator temperature high Defib temp high P Box The defibrillator was very frequently charged within a short period Avoid too frequent internal discharges Error SpO2 mod ule Error CO2 module Error temp mod Error IBP module The module mentioned is faulty Contact sales and service partners Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 1 of 10 Amendment User Manual corpuls3 Version 1 6 Alarm meldungmessage Explanation measuresErl uterung Ma nahme Failure HES data transmission HES failure P box An error occurred during data transmission of the ECG measuring and interpretation software HES Data transmission was not successful Repeat procedure f the data transmission fails repeatedly contact sales and service partners FAX transmission failed d Fax transmission was not successful Repeat procedure Contact sales and service partners Module restarts Alarm message shown on the display of the patient box The patient box restarts due to a software error No ECG cable The corpuls is in AED mode with connected shock paddles and the 4 pole ECG monitoring cable is not connected to the patient box Connect the 4 pole ECG monitoring cable No ECG cable PACER The pacer is stimulating but there is no 4 pole ECG monit
30. ed in successfully Confirmation that the user has successfully logged in Wrong therapy electrodes Connect the corPatch cable to the therapy master cable of the corpuls and place the corPatch electrodes on the patient s skin Table 10 22 Amendment to notifications in the message line Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 11 of 11
31. efibrillation mode The therapy electrodes used are not authorised for use in AED mode Defibrillator activated TEXT Event in the protocol indicating that the defibrillator mode has been activated Meaning of the parameter manual or AED Defibrillator analysis result gt gt gt Shock not recommended Event in the protocol saving the result of the ECG analysis Defibrillator analysis result gt gt gt Shock recommended Event in the protocol saving the result of the ECG analysis Defibrillator deactivated Event in the protocol indicating that the defibrillator mode has been deactivated DEMO mode ON The DEMO mode is active Check if curves and parameters are displayed Dialing signal level NUMBER Dialing process of the fax option Display of the signal strength of reception Do not touch or move patient The ECG analysis is being performed Do not touch or move patient Follow the instructions on the display Enter code NUMBER NUMBER NUMBER NUMBER User prompt to enter the access code Enter new code NUMBER NUMBER NUMBER NUMBER User prompt to enter anew access code Error GSM module The GSM module is probably faulty Contact sales and service partners Error in device BIM The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device
32. erapy master cable and place the corPatch electrodes on the patient Pacemaker failure P Box The device is possibly not functioning correctly and must not be used Contact sales and service partners Pacer active The pacer is stimulating Check if pacer therapy can be ended and if required shut off pacer Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 2 of 11 Amendment User Manual corpuls Version 1 4 Alarm message Notification Explanation measure Pacer high impedance High impedance P Box Make sure that the corPatch electrodes have full contact with the patient s skin In case of excessive hair on the patient shave the required area Paddle interface error The device is not functioning correctly and must not be used Contact sales and service partners Replace battery defib Replace battery monitor Replace battery P Box The device is possibly not functioning correctly and must not be used Contact sales and service partners Self test failed Self test failed P Box The device is possibly not functioning correctly and may no longer be used Contact sales and service partners SPO2 error P Box CO2 error P Box IBP error P Box SYND CLK error Defib SYND CLK error P box The module mentioned is faulty Contact sales and service partners Automatic synchronisation in manual defibrillation
33. fully The modules can be used together Paper jam Perform CPR Perform ventilation and cardiac massage cardio pulmonary resuscitation for as long as the device shows the message Perform CPR Power OFF User prompt to switch off corpuls After confirmation the system shuts down Recording failed Check CF card Data recording is not possible Check if the CompactFlash card is inserted correctly Re enter new code NUMBER NUMBER NUMBER NUMBER User prompt to re enter the new access code Refill printer paper Reset user code Confirmation prompt asking if the access code of the user level should be reset to factory settings Select Energy Select frequency Select intensity Select intensity frequency Select mode User prompt to select the pacer mode Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 9 of 10 Amendment User Manual corpuls3 Version 1 5 Sending fax page NUMBER Status indication during fax transmission The number of already sent pages is shown in brackets Sending fax Status indication during fax transmission Shock NUMBER J NUMBER J NUMBER Ohm TEXT Time stamp and status indication of a performed defibrillation in the protocol The selected energy the effectively released energy in brackets and the impedance in Ohm are indicated
34. gy has been released Check vital signs and continue CPR if necessary Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 10 of 11 Amendment User Manual corpuls Version 1 4 Shock recommended Defibrillation is recommended Perform defibrillation immediately Short circuit check electrodes The therapy electrodes have to be placed at a sufficient distance from each other Make sure that the therapy electrodes do not touch SIM card authorisation Status message of fax transmission Wait for authorisation of the SIM card in the mobile communications network SIM error Repeat procedure f the error occurs again check if the SIM card is inserted correctly f the error occurs again check the SIM card in another device Contact sales and service partners Start analysis User prompt to start ECG analysis in AED mode Start ECG Start new mission record Starting time of the recorded ECG in the protocol By confirming a new data record is created on the CF card Stop ECG Ending time of the recorded EGG in the protocol Switch off pacer System Power Down in NUMBER sec Count down indicating the remaining time in seconds until the system shuts down Therapy electrodes loose Connect corPatch electrodes or shock paddles to the therapy master cable of the corpuls Unlock keyboard User TEXT logg
35. ibrillator mode has been deactivated DEMO mode ON The DEMO mode is active Check if curves and parameters are displayed Dialing signal level NUMBER Dialing process of the fax option Display of the signal strength of reception Do not touch or move patient The ECG analysis is being performed Do not touch or move patient Follow the instructions on the display Enter code NUMBER NUMBER NUMBER NUMBER User prompt to enter the access code Enter new code NUMBER NUMBER NUMBER NUMBER User prompt to enter a new access code Error in device BIM The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device DEFI The corpuls is not functioning correctly and must not be used Contact sales and service partners Error in device MAN BIM The corpuls is not functioning correctly and must not be used Contact sales and service partners Event recorded Confirmation that an event has been recorded Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 5 of 10 Amendment User Manual corpuls3 Version 1 5 Event recorded NUMBER wav Event in the protocol that an event has been recorded There is a voice recording pertaining to the respective event Failure HES data transmission HES failure P box An error occurred du
36. iods If the error persists contact sales and service partners Overheated pacing impossible Pacer active The pacer is stimulating Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 8 of 11 Amendment User Manual corpuls Version 1 4 Pacer active continue anyway Confirmation prompt asking if the stimulation should be interrupted and the device should switch to manual or AED defibrillation mode Pacer active D ECG not available The pacer of the corpuls is activated and the selected intensity is more than 0 mA A D ECG cannot be performed under these circumstances Pacer active Power OFF Confirmation prompt asking if the system should shut down although the pacer is stimulating Pacer continue Pacer error pacing OFF An error occurred during pacer therapy The pacer is switched off Stimulation is interrupted Treat patient and take measures as needed Contact sales and service partners Pacer off Confirmation that the pacer has been switched off and is not stimulating Pacer on NUMBER min NUMBER mA Status indication of a performed pacer therapy in the protocol mode TEXT The stimulation frequency intensity and the selected pacer mode are indicated Pacing Stimulation via the pacer is active Pairing failed retry Connection authorisation Pairing has failed Pairing has to be performed
37. irty No connection to Patient Box The wireless communication between patient box and monitoring unit defibrillator is interrupted or could not be established Make sure that the distance between the modules is no more than 10 m and that no obstacles impede the wireless communication If needed use the corpuls as a compact device The communication between the connected modules patient box and monitoring unit defibrillator is interrupted or could not be established Check if one of the infrared interfaces is covered or extremely dirty No ECG cable No ECG cable in DEMAND mode For operation of the pacer in DEMAND mode the 4 pole ECG monitoring cable has to be connected to the patient and to the corpuls No SIM card Pacer active The pacer is stimulating Pacer active Continue Confirmation prompt asking if the stimulation should be interrupted and the corpuls should switch to manual or AED defibrillation mode Pacer active D ECG not available The pacer of the corpuls is activated and the selected intensity is more than 0 mA A D ECG cannot be performed under these circumstances Pacer continue Pacer error Pacing OFF An error occurred during pacer therapy The pacer is switched off Stimulation is interrupted Treat patient and take measures as needed Contact sales and service partners Pacer mode TEXT selected Event in the protocol recording
38. med TEXT Event with time stamp in the protocol that an occurred alarm has been confirmed by the user Alarm suspension NUMBER sec Biphasic module selftest error Defib selftest error P Box The alarm suspension is activated The count down shows the remaining time in seconds until the alarm suspension ends automatically The corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Check pacer The pacer is stimulating but there is no connection between the monitoring unit and the defibrillator pacer The wireless communication between the patient box and the monitoring unit defibrillator has been interrupted or could not be established Make sure that the distance between the modules is not more than 10 m and that no barriers are compromising the wireless connection If necessary use the corpuls as compact device Communication between the patient box and the monitoring unit defibrillator has been interrupted or could not be established Check if one of the two infrared interfaces is covered or dirty CO2 apnoea CO2 apnoea P Box An apnoea has been detected Check respiration Confirm alarms After the user has acknowledged the alarm messages contained in the following alarm list and has taken corresponding measures on the patient those can be confirmed Defibrillator failure 4 The corpuls is possibly not functioning corr
39. nt to alarm messages 10 4 Amendment to Notifications and Information in the Protocol The notifications marked by do not require further explanation as they are self explanatory The measure to be taken is to follow the instruction given in the notification The following notification texts can be shown on the display or are printed out in the protocol in alphabetical order Due to translation the sequence of the alarm messages in English differs from that in German Notification in the message line and information in the protocol Monitoring unit powered off Patient box powered off Defibrillator pacer powered off Explanation measure Event in the protocol indicating that the respective module has been switched off Monitoring unit powered on Patient box powered on Defibrillator pacer powered on Event in the protocol indicating that the respective module has been switched on activated AED Time stamp and status indication in the protocol that the defibrillator has been activated in AED mode activated MANUAL Time stamp and status indication in the protocol that the defibrillator has been activated in manual mode Alarm confirmed TEXT Event with time stamp in the protocol that an occurred alarm has been confirmed by the user Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 3 of 10 Amendment User Manual corpuls3 Version
40. ole ECG monitoring cable has to be connected to the patient and to the corpuls Pacer active The pacer is stimulating Pacer active Continue Confirmation prompt asking if the stimulation should be interrupted and the corpuls should switch to manual or AED defibrillation mode Pacer active D ECG not available The pacer of the corpuls is activated and the selected intensity is more than 0 mA A D ECG cannot be performed under these circumstances Pacer active Power OFF Pacer continue Pacer error Pacing OFF An error occurred during pacer therapy The pacer is switched off Stimulation is interrupted Treat patient and take measures as needed Contact sales and service partners Pacer mode TEXT selected Event in the protocol recording the switch between the pacer modes FIX and DEMAND No alarm Pacer OFF Confirmation that the pacer has been switched off and is not stimulating Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 8 of 10 Amendment User Manual corpuls3 Version 1 6 Pacer ON NUMBER min NUMBER mA mode TEXT Status indication of a performed pacer therapy in the protocol The stimulation frequency intensity and the selected pacer mode are indicated Pairing failed Retry The connection between the modules could not be established Connection authorisation Pairing has failed
41. oring cable connected or individual ECG electrodes are loose Check if the 4 pole ECG monitoring cable is connected correctly to the patient box Check ECG electrodes Make sure that all contact clips are connected correctly to the electrodes and or all ECG electrodes are correctly placed on the patient s skin No GSM PIN configured The PIN belonging to the SIM card has not been configured No SIM card present Insert a SIM card and configure the PIN Paddle interface error Error in device PIF The corpuls is not functioning correctly and must not be used Contact sales and service partners Pairing result Status message in the protocol after connection authorisation Pairing has taken place Paper jam Refill printer paper Replace battery defib Replace battery monitor Replace battery P Box The corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Self test failed Self test failed P Box The corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Self test failed The corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 2 of 10 Amendment User Manual corpuls3 Version 1 6 SYND CLK error P Box A
42. ork Status message of fax transmission The GSM module is logging onto the mobile communications network Mission end Event in the protocol indicating the ending time of the device mission Mission start Event in the protocol indicating the starting time of the device mission New code invalid Retry User prompt to re enter the new access code if the repetition was wrong New module Start pairing Two modules have been connected that do not have a connection authorisation Pairing Confirm if these modules are to receive a connection authorisation and the existing connection authorisation should be deleted NIBP result NUMBER NUMBER NUMBER mmHg Result of the NIBP measurement in the protocol Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 7 of 10 Amendment User Manual corpuls3 Version 1 5 No connection to Defibrillator Unit The wireless communication between defibrillator and monitoring unit patient box is interrupted or could not be established Make sure that the distance between the modules is no more than 10 m and that no obstacles impede the wireless communication If needed use the corpuls as a compact device The communication between the connected modules defibrillator and monitoring unit patient box is interrupted or could not be established Check if one of the infrared interfaces is covered or extremely d
43. rement failed Temperature measurement could not be performed correctly Check temperature sensor and its correct placement on the patient Test resistor temperatur high Resistor temp high P Box Defibrillation was performed on the test contacts too frequently in succession Avoid further defibrillations on the test contacts Therapy eletrodes loose Check the correct placement of the corPatch electrodes on the patient Unlock keyboard Confirmation prompt asking if the keyboard lock should be disengaged User TEXT logged in successfully Notification which user level has been logged in Table 10 23 Amendment to notifications in the message line Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 10 of 10 Amendment User Manual corpuls3 Version 1 5 10 Procedure in Case of Malfunctions 10 3 Amendment to Alarm Messages The following alarm messages can be shown on the display in alphabetical order Due to translation the sequence of the alarm messages in English differs from that in German Alarm message Explanation measures Alarm suspension NUMBER s The alarm suspension is activated The count down shows the remaining time in seconds until the alarm suspension ends automatically Biphasic module selftest error Defib selftest error P Box Check pacer The corpuls is possibly not functioning correctly and must not be used
44. ring data transmission of the ECG measuring and interpretation software HES Data transmission was not successful Repeat procedure f the data transmission fails repeatedly contact sales and service partners Fax transfer failure An error has occurred during the fax transmission The fax has not been transferred Repeat fax transfer Fax transfer finished NUMBER page s sent Confirmation that the fax has been successfully transferred with the indicated amount of pages GSM error Connection not possible Possibly a wrong fax number has been dialed Repeat dialing GSM error Line is busy The dialed fax line is busy Try to establish the fax connection at a later point in time GSM error Lost modem control Switch off the corpuls and switch on again f the message text is displayed permanently contact sales and service partners GSM error Network not available Signal strength of reception is too low No connection can be established to the mobile communications network f possible improve reception according to location Repeat procedure possibly at a later time GSM error No SIM card Check SIM card Insert SIM card GSM error SIM card error Check SIM card Try re inserting SIM card f the error cannot be eliminated contact the mobile communications operator or the sales and service partners GSM error
45. risation should be deleted NIBP result NUMBER NUMBER NUMBER mmHg Result of the NIBP measurement in the protocol Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 7 of 10 Amendment User Manual corpuls3 Version 1 6 No connection to Defibrillator Unit The wireless communication between defibrillator and monitoring unit patient box is interrupted or could not be established Make sure that the distance between the modules is no more than 10 m and that no obstacles impede the wireless communication If needed use the corpuls as a compact device The communication between the connected modules defibrillator and monitoring unit patient box is interrupted or could not be established Check if one of the infrared interfaces is covered or extremely dirty No connection to Patient Box The wireless communication between patient box and monitoring unit defibrillator is interrupted or could not be established Make sure that the distance between the modules is no more than 10 m and that no obstacles impede the wireless communication If needed use the corpuls as a compact device The communication between the connected modules patient box and monitoring unit defibrillator is interrupted or could not be established Check if one of the infrared interfaces is covered or extremely dirty No ECG cable in DEMAND mode For operating the pacer in DEMAND mode the 4 p
46. s appears if the patient box or the defibrillator unit are still in operation while the monitoring unit is already switched off This is supposed to avoid unintended and unobserved draining of the batteries in the device The measures to be taken in case of this error message are described below Fig 4 10 Fig 4 11 in version 1 5 in chapter 4 2 2 Switching Off of the user manual These are necessary and correctly functioning error messages of the device It is essential that the user either knows the necessary corrective actions or has quick access to these in the user manual 3 Potential Risk The device cannot be operated correctly due to the missing or incorrectly transmitted device data The transmission of medical data to the monitoring unit is faulty 4 Safety Information The users should be trained in the exchange of modules if this is provided for in the mission procedure After the corpuls has been serviced the user should at least perform the daily check Obviously this has not been done as described in chapter 9 Maintenance and Tests of the manual If the connection test of the modules had been performed for details see Table 4 1 in chapter 4 1 2 the device would have requested a new correctly performed pairing procedure Doctuumer name UNAllgomeln Te cnnische Pe ge 207 E pan a Relezse dale eciood06 QM _ t e m tn L se name Klaus Stemple Mena
47. ssive hair shave the required area on the patient s skin Initialising GSM modem Status indication during fax transmission Invalid retry Keyboard locked Keyboard lock has been engaged Keyboard locked press and hold HOME to unlock Keyboard unlocked Keyboard lock has been disengaged Line is busy The dialed fax line is busy Lock keyboard Logging onto the network Status message of fax transmission The GSM module is logging onto the mobile communications network Mission end Event in the protocol indicating the ending time of the device mission Mission start Event in the protocol indicating the starting time of the device mission Module restarts The module restarts due to an internal error Amendment to User Manual corpuls3 EN Version 1 4 P N 04130 2 7 of 11 Amendment User Manual corpuls Version 1 4 User prompt to re enter the new access code ifthe New Code invalid retry BP repetition was wrong Two modules have been connected that do not have a connection authorisation Pairing New Module start pairing Confirm if these modules are to receive a connection authorisation and the existing connection authorisation should be deleted NIBP result NUMBER NUMBER Result of the NIBP measurement in the protocol INUMBER mmHg The wireless communication between defibrillator and monitoring
48. tch Retry The verification of the new access code did not match the earlier entry To repeat the process confirm the prompt and enter the access code again Configuration loaded Configuration reset Configuration stored Connect ECG cable Connect pacer cable User prompt to connect the therapy master cable to the therapy electrodes Connect therapy electrodes Connected Sending fax Status message during fax transmission Connection to required number has been established Fax transmission is active D ECG NUMBER not saved NUMBER The recorded D ECG could not be saved because the CF card is possibly full the CF card is possibly not inserted correctly the CF card is possibly faulty or the writing process onto the CF card has failed After deleting or exchanging the CF card repeat the process If the error persists contact sales and service partners D ECG NUMBER saved A D ECG has been saved The number of the D ECG is shown in brackets D ECG fax sent Confirmation that the D ECG has been sent via fax Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 4 of 10 Amendment User Manual corpuls3 Version 1 6 Notification in the message line and information in the protocol Explanation measure Defibrillation only possible in manual defi mode User prompt to switch from AED mode to manual d
49. that the user did not react correctly to the message Pairing failed and that this faulty module combination was used on a patient Cause for the pairing request of the device was a new module combination after servicing the device Consequently the patient box did not start correctly At the attempt to switch off the corpuls as a compact device the message Check modules was not interpreted correctly neither There is no information available about the possible effects of this incident on the patient Missing instructions in the summary list of the user manual might be the cause for the wrong reaction of the crew to the warning messages 2 Precondition for the Ooccurrence of the Error When a new module is integrated into the device combination of the corpuls e g the patient box is transferred with the patient into another vehicle device data have to be exchanged via the infrared interface so that the radio connection can function properly If this procedure was carried out correctly the message Pairing successful appears If errors have occurred e g due to foreign bodies on the infrared interfaces the message Pairing failed is shown on the monitoring unit Description in chapter 3 2 1 Connection Authorisation Pairing of the user manual If the error is not eliminated it may occur that the patient box or the defibrillator unit of the corpuls is not switched off The message Check modules alway
50. the switch between the pacer modes FIX and DEMAND Pacer OFF Confirmation that the pacer has been switched off and is not stimulating Amendment to User Manual corpuls3 EN Version 1 5 P N 04130 2 8 of 10 Amendment User Manual corpuls3 Version 1 5 Pacer ON NUMBER min NUMBER mA mode TEXT Status indication of a performed pacer therapy in the protocol The stimulation frequency intensity and the selected pacer mode are indicated Pairing failed Retry The connection between the modules could not be established Connection authorisation Pairing has failed Pairing has to be performed again so that the modules can be used together Confirmation of the question if the pairing should be performed again is necessary Confirm in order to repeat pairing For further details see chapter 3 2 1 If pairing fails repeatedly the corpuls is possibly not functioning correctly and must not be used Contact sales and service partners Pairing failed Software version conflict Connection authorisation Pairing has failed The required modules cannot be connected due to different software versions For further details see chapter 3 2 1 Contact sales and service partners Pairing result NUMBER Status message after connection authorisation Pairing in the protocol Pairing successful The connection authorisation has been issued success
51. transmission Shock NUMBER J NUMBER J NUMBER Ohm TEXT Time stamp and status indication of a performed defibrillation in the protocol The selected energy the effectively released energy in brackets and the impedance in Ohm are indicated Indication of the defibrillation mode used Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 9 of 10 Amendment User Manual corpuls3 Version 1 6 Shock not recommended The result of the ECG analysis indicates that a shock is not recommended Take measures as needed If necessary continue cardio pulmonary resuscitation Shock performed Defibrillation energy has been released Check vital signs and continue cardio pulmonary resuscitation if necessary Short circuit Check electrodes The therapy electrodes have an electric connection short circuit Make sure that the therapy electrodes do not touch SIM card authorisation Status message of fax transmission Wait for authorisation of the SIM card in the mobile communications network Start ECG Starting time of the recorded ECG in the protocol Start new mission By confirming a new data record is created on the CF card Stop ECG Ending time of the recorded ECG in the protocol System Power Down in NUMBER sec Count down indicating the remaining time until the system shuts down Temperature measu
52. utomatic synchronisation in manual defibrillation mode does not SYND CLK error Defib work No shock can be delivered The corpuls is not functioning correctly and must not be used Contact sales and service partners Time Date inv P Box Alarm message shown on the display of the patient box The configured time or the date is invalid Set the correct time date Time Date invalid The configured time or the date is invalid Set the correct time date Table 10 22 Amendment to alarm message 10 4 Amendment to Notifications and Information in the Protocol The notifications marked by do not require further explanation as they are self explanatory The measure to be taken is to follow the instruction given in the notification The following notification texts can be shown on the display or are printed out in the protocol in alphabetical order Due to translation the sequence of the alarm messages in English differs from that in German Notification in the message line and information in the protocol Explanation measure activated AED Time stamp and status indication in the protocol that the defibrillator has been activated in AED mode activated MANUAL Time stamp and status indication in the protocol that the defibrillator has been activated in manual mode Charging not possible A technical error occurred The temperature of the generator has exceeded a limit
53. value due to a high amount of discharges Allow the system to cool down in rest periods If the error persists contact sales and service partners Check modules If there is no connection between the monitoring unit and the patient box and or the defibrillator pacer at the time of switch off or if there is a timing problem between the modules this is communicated to the user by a message on the display In this case disconnect the the modules and check if all modules are switched off If this is not so switch off the respective modules via the On Off key Amendment to User Manual corpuls3 EN Version 1 6 P N 04130 2 3 of 10 Amendment User Manual corpuls3 Version 1 6 Notification in the message line and information in the protocol Explanation measure Check therapy electrodes The therapy electrodes are not connected correctly to the therapy master cable Check the connection of the plugs and adjust if necessary If the message persists contact sales and service partners Circuit open Check pacer electrodes The corPatch electrodes are not connected correctly to the patient or they have a too high resistance to the patient s skin Stimulation is not possible Check the expiry date of the electrodes if they are dried out and if they are placed correctly on the patient Code changed Confirmation that the access code has been successfully changed Code misma

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