SAFETV INFORMATION
SAFETV INFORMATION
Technical Bulletin No. 006
GS Elektromedizinische Geräte
G. Stemple GmbH
Hauswiesenstraße 26
0-86916 Kaufering
Tel. +49819165722-0
Fax +498191 65722-22
[email protected]
www.corpuls.com
Target audience
No .
Date
Numbor 01 pages
All users
2010-04-06
7
006
- - - - - - - - - - - ----t--:-------------,---------f-c------"------/>.ffected products
Serial numbers / Lot identification
Software / Firmware
corpuls 3
User Manual
Pertaining to software version
1.4.0 ; 1.5.0 und 1.6.0
Dear Sir or Madam,
we would like to inform you via this letter about an amendment to the user manual of the corpuls 3
defibrillator/monitoring system.
This letter will contain information on:
•
•
the reason for the amendment and on possible consequences,
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
corpuls3 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.
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translation date:
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U:\AlIgemein\Technische
Bulletins\TB 006 eng 01.doc
2010-03-16
Corinna Gaubatz
Page
1017
Re lease date.:
Release name:
2010-04 -06
Klaus Stemple
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SAFETY INFORMATION
Technical Bulletin No. 006
1.
.... corpuls®
Error description
There has been one reported case 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 corpuls3 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 corpuls3 (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. Qescription 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 3 is
not switched off. The message "Check modules" always appears if the patient box or the defibrillator
unit are still in operation while the monitoring unit is al ready 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 corpuls3 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.
Doeument na me
and loeation:
trans lation date:
1 rans1ator na me:
U:IA llgeme i nlT eehnisehe
l1ulletinslTB 006 eng Oi. ooe
Page
2017
20 10-03-16
Re lease date.:
Release name:
2010·04 ·06
Corinna Gaubatz
Klaus Stemp le
a
~
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~
SAFETY INFORMATION
Technical Bulletin No. 006
5.
.... corpuls®
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:
•
•
The correct procedure when integrating new modules in the device combination,
possible errors that can occur doing so and how to remedy them,
•
•
the importance of the message "Check modules" when switching off the corpuls 3 and
the necessity to check the modules for correct switch-off, if the message was displayed.
For further improvement and to ass ist the 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 ).
lJocu ment na me
and loeation:
trans lation date:
1 rans lator na me:
U :\Allge mei nlTechn ische
Bulietinsl TB 006 eng 01. doc
2010-03-1 6
Corinna Gaubatz
Page
3017
Re lease date. :
Re lease na me:
2010-04 -06
Klaus Stemple
~
,~
.... @i
~~
SAFETY INFORMATION
.... corpuls®
Technical Bulletin No. 006
Contact person of the manufacturer for questions:
Dipl.-Ing. (FH) Axel Bischoff
VP Product Management
Leiter Produktmanagement
+49 (0) 81 91 657220
+49 (0) 81 91 6 57 22 22
[email protected]
Tel. :
Fax:
E-Mail :
Kind regards
GS Elektromedizinische Geräte G. Stemple GmbH
Managing Director
Geschäftsführer
Doeu '"<1ent name
and loeation:
translation date:
1 rans lato r name:
G nera Manager R&D/Production
Ge
ftsführer F&E/Fertigung
U:\AlI ge mein\Teehn isehe
Bul 'etins\Tß 006 eng 01 .doe
2010-03-1 6
Corinna Gaubatz
Page
4017
Release date.:
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Klaus Stemp le
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, ..,,1 @i
,~
SAFETY INFORMATION
Technical Bulletin No. 006
.... corpuls®
Annex A
Illustration of the device combination corpuls3
1 - Monitoring unit
2 - Patient box
3 - Defibrillator
Rating ptates with position of the seriat numbers
System - Info 1
Monitoring Unit
Patient box
REL-1.6,0_C3_BD
REL-1.6,0_C3_BD
2000000036760305
D7000000366AD105
Defibrillator
REL-1.6,0_C3 BD
DA000000366E5A05
Info 1
L
(aneel
OK
•
System - Info 2
_! t, r I
- -,'t,
~I "" • t:'
1_' I _ t : ' I 1:.1
Biphasic module
M:v2,00V/S:v2,00L
ECG
1K
996lvO,3,14,5/V0,3,14,6 --
Sp02
NIBP
C02
LM3,390/SM V220/0829 --
18P
v 13/V7/V7
Temp
GSM
ECG-Interpretation
v31V31V4
MC55 04.00
18,24-03
Data Interface
0212
4
Info 2
Document name
and loeation:
translation date:
Trans lator name:
Jlll
Il
I"-
00:18:da:00:b4:bd
•
aneel
U:\Allgemein\1 eenn isehe
Bul iei ins\TB 006 eng 01.doe
2010·03-1 6
Corinna Gaubatz
OK
Page
5 of 7
Re lease date.:
Release na;ne:
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Klaus Stemple
a
..,;,:.~$
~
QM
~
SAFETY INFORMATION
Technical Bulletin No. 006
.... 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 Geräte G.
Stemple GmbH 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/MsfTitle:
Fax:
Company stamp:
Phone:
E-Mail:
Date/Signature:
Please return this confirmation form until 2010-04-30 at the latest to:
GS Elektromedizinische Geräte G. Stemple GmbH, Hauswiesenstrasse 26, D-86916 Kaufering
Fax: + 49 8191 65722 - 22
Docu ment name
and location:
trans lation date:
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U:\Allge meinITechnische
Bulletinsl Tß 006 eng 01.doc
2010·03-1 6
Co rinna Gaubatz
Page
6017
Release date.:
Re lease na me:
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Klaus Stemple
~~-'
r
~2
SAFETY INFORMATION
Technical Bulletin No. 006
Annex C
Authorised corpuls®sales and service partners
Please consult our homepage for international sales and service addresses:
www.corpuls.com
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trans läon date:
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tt'~
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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/measuresErläuterung/Maßnahme
Alarm confirmed; [TEXT]
Event with time stamp in the protocol that an occurred alarm has
been confirmed by the user.
Alarm suspension:
[NUMBER] sec
The alarm suspension is activated. The count-down shows the
remaining time in seconds until the alarm suspension ends
automatically.
Biphasic module selftest
error
 The corpuls3 is possibly not functioning correctly and must not be
used.
Defib selftest error (P-Box)
 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 corpuls3as 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.
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 corpuls3 is possibly not functioning correctly and must not be
used.
 Check respiration.
 Contact sales and service partners.
Defibrillator temperature
high
 The defibrillator was very frequently charged within a short period.
 Avoid too frequent internal discharges.
Defib temp. high (P-Box)
Error SpO2 mod(ule)
Error CO2 module
Error temp. mod.
 The module mentioned is faulty.
 Contact sales and service partners.
Error IBP module
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/measuresErläuterung/Maßnahme
Failure HES data
transmission
 An error occurred during data transmission of the ECG measuring
®
and interpretation software HES .
HES failure (P-box)
 Data transmission was not successful.
 Repeat procedure.
 If 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 corpuls3 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 corpuls3 is not functioning correctly and must not be used.
Error in device (PIF)
 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)
 The corpuls3 is possibly not functioning correctly and must not be
used.
Replace battery (P-Box)
 Contact sales and service partners.
Self test failed
 The corpuls3 is possibly not functioning correctly and must not be
used.
Self test failed (P-Box)
 Contact sales and service partners.
Self test failed
 The corpuls3 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
SYND CLK error (P-Box)
SYND CLK error (Defib)
Version 1.6
 Automatic synchronisation in manual defibrillation mode does not
work. No shock can be delivered.
 The corpuls3 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 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 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.
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 defibrillation 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;
>>> Shock not recommended
Event in the protocol, saving the result of the
ECG analysis.
Defibrillator analysis result;
>>> 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 a new access code.
Error GSM module
 The GSM module is probably faulty.
 Contact sales and service partners.
Error in device (BIM)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (DEFI)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (MAN-BIM)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (PIF)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (PIF)
 The corpuls3 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
 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 corpuls3 and switch on again.
 If 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.
 If 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.
 If 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)).
 If 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
GSM error: Wrong GSM PIN
Version 1.6
 The personal identification number (PIN)
entered is wrong.
 Repeat.
High impedance
 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 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.
Logging onto 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.
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 1.6 – 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 corpuls3as 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 corpuls3as 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
pole ECG monitoring cable has to be connected
to the patient and to the corpuls3.
Pacer active
The pacer is stimulating.
Pacer active - Continue?
Confirmation prompt asking if the stimulation
should be interrupted and the corpuls3 should
switch to manual or AED defibrillation mode.
Pacer active - D-ECG not available
 The pacer of the corpuls3 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.
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Pacer ON [NUMBER]/min, [NUMBER] mA,
mode [TEXT]
Version 1.6
 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 corpuls3 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 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.
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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 cardiopulmonary 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 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 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
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Amendment User Manual corpuls3
10
Version 1.5
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
 The corpuls3 is possibly not functioning correctly and must not be
used.
Defib selftest error (P-Box)
 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 corpuls3as 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.
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.
 Check respiration.
 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 corpuls3 is possibly not functioning correctly and must not be
used.
 Contact sales and service partners.
Defibrillator temperature
high
 The defibrillator was very frequently charged within a short period.
 Avoid too frequent internal discharges.
Defib temp. high (P-Box)
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Error GSM module
Version 1.5
 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.
Module restarts
 Alarm message shown on the display of the patient box.
 Contact sales and service partners.
 The patient box restarts due to a software error.
No ECG cable
 The corpuls3 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 corpuls3 is not functioning correctly and must not be used.
 Contact sales and service partners.
Replace battery (defib)
Replace battery (monitor)
 The corpuls3 is possibly not functioning correctly and must not be
used.
Replace battery (P-Box)
 Contact sales and service partners.
Self test failed
 The corpuls3 is possibly not functioning correctly and may no
longer be used.
Self test failed (P-Box)
 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
 Defibrillation was performed on the test contacts too frequently in
succession.
Resistor temp. high (P-Box)
 Avoid further defibrillations on the test contacts.
Therapy electrodes loose
Check the correct placement of the corPatch electrodes on the
patient.
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Time/Date inv. (P-Box)
Version 1.5
 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
Amendment 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
Explanation/measure
[Monitoring unit]
powered off
Event in the protocol indicating that the
respective module has been switched off.
[Patient box]
powered off
[Defibrillator/pacer]
powered off
[Monitoring unit]
powered on
Event in the protocol indicating that the
respective module has been switched on.
[Patient box]
powered on
[Defibrillator/pacer]
powered 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.
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Charging not possible
Version 1.5
 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 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.
 If possible, improve reception according to
location.
 Repeat procedure, possibly at a later time.
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D-ECG ([NUMBER]) saved
Version 1.5
 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]
 Event in the protocol indicating that the
defibrillator mode has been activated.
 Meaning of the parameter:
manual or AED
Defibrillator analysis result;
>>> Shock not recommended
Event in the protocol, saving the result of the
ECG analysis.
Defibrillator analysis result;
>>> 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 a new access code.
Error in device (BIM)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (DEFI)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (MAN-BIM)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Event recorded
Confirmation that an event has been recorded.
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Amendment User Manual corpuls3
Event recorded ([NUMBER].wav)
Version 1.5
 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 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)
GSM error: Connection not possible
Confirmation that the fax has been successfully
transferred with the indicated amount of pages.
 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 corpuls3 and switch on again.
 If 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.
 If 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.
 If 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)).
 If the SIM card cannot be unlocked, contact
first the mobile communications operator and
then the sales and service partners.
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GSM error: Wrong GSM PIN
Version 1.5
 The personal identification number (PIN)
entered is wrong.
 Repeat.
High impedance
 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 ([NUMBER])
 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 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.
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.
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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 corpuls3as 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 corpuls3as 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 corpuls3.
No SIM card
--
Pacer active
The pacer is stimulating.
Pacer active - Continue?
Confirmation prompt asking if the stimulation
should be interrupted and the corpuls3 should
switch to manual or AED defibrillation mode.
Pacer active - D-ECG not available
 The pacer of the corpuls3 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 the switch
between the pacer modes FIX and DEMAND.
Pacer OFF
Confirmation that the pacer has been switched
off and is not stimulating.
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Amendment User Manual corpuls3
Pacer ON [NUMBER]/min, [NUMBER] mA,
mode [TEXT]
Version 1.5
 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 corpuls3 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
successfully.
 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 corpuls3.
 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.
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Amendment User Manual corpuls3
Sending fax (page [NUMBER])...
Version 1.5
 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.
Shock not recommended
Shock performed
 Indication of the defibrillation mode used.
 The result of the ECG analysis indicates that a
shock is not recommended.
 Take measures as needed. If necessary,
continue cardio-pulmonary resuscitation.
 Defibrillation energy has been released.
 Check vital signs and continue cardiopulmonary 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
Stop ECG
Starting time of the recorded ECG in the
protocol.
By confirming, a new data record is created on
the CF card.
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.
Start new mission?
Table 10-22
Amendment to notifications in the message line
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Amendment User Manual corpuls3
10
Version 1.4
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/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
 The device is possibly not functioning correctly and must not be
used.
Defib selftest error (P-Box)
 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 corpuls3 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.
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.
Defib(rillator) failure (X)
 The “X” stands for a failure number from 1 to 3
 Check respiration.
 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.
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Version 1.4
Alarm message/Notification
Explanation/measure
Defibrillator temperature high
 The defibrillator was very frequently charged within a short
period.
Defib temp. high (P-Box)
 Avoid too frequent internal discharges.
ECG cable (4 pole) loose
4-pole cable loose (P-Box)
ECG cable (6 pole) loose
Check if the 4 pole ECG cable is connected correctly to the
patient box.
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 ECG
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)
No ECG cable
Connect corPatch electrodes or shock paddles to the therapy
master cable of the corpuls3.
 The corpuls3 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)
Pacemaker failure (P-Box)
Connect the corPatch cable to the corpuls3 therapy master
cable and place the corPatch electrodes on the patient.
 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.
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Alarm message/Notification
Explanation/measure
Pacer high impedance
 Make sure that the corPatch electrodes have full contact with
the patient’s skin.
High impedance (P-Box)
 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 (monitor)
 The device is possibly not functioning correctly and must not be
used.
Replace battery (P-Box)
 Contact sales and service partners.
Self test failed
The device is possibly not functioning correctly and may no longer
be used.
Replace battery (defib)
Self test failed (P-Box)
Contact sales and service partners.
SPO2 error (P-Box)
 The module mentioned is faulty.
CO2 error (P-Box)
 Contact sales and service partners.
IBP error (P-Box)
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.
Test-resistor temperatur high
 Defibrillation was performed on the test contacts too frequently
in succession.
Resistor temp. high (P-Box)
 Check temperature sensor and its correct placement on the
patient.
 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.
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Alarm message/notification
Version 1.4
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.
 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.
 The therapy electrodes are not connected
correctly to the therapy master cable.
Check therapy electrodes
 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
Code mismatch - retry?
Confirmation that the access code has been
successfully changed.
 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
Check the connecting plug of the therapy master
cable. If necessary, connect the therapy electrodes
with the connecting plug.
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 Status message during fax transmission
Connected, Sending fax
 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; >>> [TEXT]
Event in the protocol, saving the result of the ECG
analysis.
Defibrillator is charging
Notification that the defibrillator is charging.
DEMO Mode ON
Dialing... (signal level: [NUMBER] %)
 The DEMO mode is active.
 Check if curves and parameters are displayed.
 Dialing process of the fax option.
 Display of the signal strength of reception.
 The ECG analysis is being performed.
Do not touch or move patient
 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 corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (DEFI)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (MAN-BIM)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Error in device (PIF)
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
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Error in device (PIF)
Version 1.4
 The corpuls3 is not functioning correctly and
must not be used.
 Contact sales and service partners.
Event recorded
Event recorded ([NUMBER].wav)
Failure HES data transmission
HES failure
Confirmation that an event has been recorded.
 Event in the protocol that an event has been
recorded.
 There is a voice recording pertaining to the
respective event.
 An error has 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.
 An error has occurred during the fax transmission.
FAX transfer failure
 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 corpuls3 and switch on again.
 If 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.
 If 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.
 If the error cannot be eliminated, contact the
mobile communications operator or the sales and
service partners.
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GSM error: SIM card locked
Version 1.4
 Check SIM card.
 Enter safety code for unlocking the SIM card (see
instructions of operating company, e.g. Personal
Unblocking Key (PUK)).
 If the SIM card cannot be unlocked, contact first
the mobile communications operator and then the
sales and service partners.
GSM error: Wrong GSM PIN
 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.
High impedance
 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 excessive
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?
- Status message of fax transmission.
Logging onto the network
 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.
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New Code invalid - retry?
Version 1.4
User prompt to re-enter the new access code, if the
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]
([NUMBER]) mmHg
Result of the NIBP measurement in the protocol.
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 corpuls3as 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 dirty.
No connection to P 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 corpuls3as 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.
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 corpuls3.
No PIN available
For operating the SIM card in the GSM module it is
necessary to enter a 4 figure PIN in the
configuration menu.
No SIM card
- A technical error occurred.
Overheated - pacing impossible
 The temperature of the generator has exceeded a
limit value.
 Allow the system to cool down in rest periods.
If the error persists, contact sales and service
partners.
Pacer active
The pacer is stimulating.
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Pacer active - continue anyway?
Pacer active - D-ECG not available
Version 1.4
Confirmation prompt asking if the stimulation should
be interrupted and the device should switch to
manual or AED defibrillation mode.
 The pacer of the corpuls3 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
- An error occurred during pacer therapy.
Pacer error - pacing OFF
 The pacer is switched off. Stimulation is
interrupted.
 Treat patient and take measures as needed.
 Contact sales and service partners.
Pacer off
Pacer on [NUMBER] /min, [NUMBER] mA,
mode [TEXT]
Pacing
Confirmation that the pacer has been switched off
and is not stimulating.
 Status indication of a performed pacer therapy in
the protocol.
 The stimulation frequency, intensity and the
selected pacer mode are indicated.
Stimulation via the pacer is active.
 Connection authorisation (Pairing) has failed.
 Pairing has to be performed again so that the
modules can be used together.
Pairing failed - retry?
 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 device is possibly
not functioning correctly and must not be used.
Contact sales and service partners.
 Connection authorisation (Pairing) has failed.
 The required modules cannot be connected due
to different software versions.
Pairing failed - Software version conflict
 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:
Pairing successful
Status message after connection authorisation
(Pairing) in the protocol.
 The connection authorisation has been issued
successfully.
The modules can be used together.
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Pause pacing?
Confirmation prompt asking if the stimulation should
be interrupted.
Perform CPR
Perform ventilation and cardiac massage (cardiopulmonary 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 be
shut down..
Ready for shock
Message that the corpuls3 is ready to deliver a
shock in defibrillation mode.
 Data recording is not possible.
Recording failed - Check CF card
 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
--
Select frequency
--
Select intensity
--
Select intensity/frequency
--
Select mode
User prompt to select the pacer mode.
®
 Status indication during fax transmission.
Sending fax (page [NUMBER])...
 The number of already sent pages is shown in
brackets.
Sending fax...
Status indication during fax transmission.
 Time stamp and status indication of a performed
defibrillation in the protocol.
Shock [NUMBER] J ([NUMBER] J),
[NUMBER] Ohm (%s)
 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 energy has been released.
Check vital signs and continue CPR if necessary.
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Shock recommended
Short circuit - check electrodes
Version 1.4
 Defibrillation is recommended.
 Perform defibrillation immediately.
 The therapy electrodes have to be placed at a
sufficient distance from each other.
 Make sure that the therapy electrodes do not
touch.
 Status message of fax transmission.
SIM card authorisation...
 Wait for authorisation of the SIM card in the
mobile communications network.
 Repeat procedure.
 If the error occurs again, check if the SIM card is
inserted correctly.
SIM error
 If 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
Starting time of the recorded ECG in the protocol.
Start new mission record?
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 in
seconds until the system shuts down.
Therapy electrodes loose
Connect corPatch electrodes or shock paddles to
the therapy master cable of the corpuls3.
Unlock keyboard?
--
User [TEXT] logged in successfully
Confirmation that the user has successfully logged
in.
Wrong therapy electrodes
Connect the corPatch cable to the therapy master
cable of the corpuls3 and place the corPatch
electrodes on the patient’s skin.
Table 10-22
Amendment to notifications in the message line
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