Weinmann MEDUCORE Standard2 User manual

MEDUCORE Standard2
Monitor/Defibrillator
Instructions for use of devices from software version 3.1
Read these instructions for use before using the product. Ignoring the
instructions for use may lead to serious injury or death.

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Table of contents
Table of contents
1 Introduction 8
1.1 About this document ..................................................................... 8
1.2 Explanation of warnings ................................................................ 9
1.3 Description of function .................................................................. 9
2 Safety 11
2.1 Intended purpose ........................................................................ 11
2.2 Intended areas of application ...................................................... 12
2.3 Possible side effects/complications ............................................... 12
2.4 Exclusions and limitations of the intended purpose ...................... 13
2.5 Requirements on the user ............................................................ 13
2.6 Safety information ....................................................................... 14
2.7 General instructions .................................................................... 33
3 Description 34
3.1 Overview ..................................................................................... 34
3.2 Control panel .............................................................................. 35
3.3 Display ........................................................................................ 37
3.4 Symbols in the display ................................................................. 54
3.5 Battery and battery status indicator ............................................. 57
3.6 Charging station ......................................................................... 59
3.7 Printer and printer display ........................................................... 60
3.8 Components and accessories ....................................................... 61
3.9 Transport options ........................................................................ 71
3.10 Options ....................................................................................... 72
4 Preparation 74
4.1 Mounting the device ................................................................... 74
4.2 Stowing components and accessories .......................................... 76
4.3 Connecting a power supply ......................................................... 83
4.4 Using the battery ......................................................................... 86
4.5 Using the charging station ........................................................... 89
4.6 Using an SD card ......................................................................... 92

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4.7 Preparing printer (only with Printing option) ................................. 94
5 Function check 103
5.1 Intervals .................................................................................... 104
5.2 Carrying out a function check .................................................... 104
5.3 Uploading function check to WEINMANN Connect ..................... 112
5.4 Checking ECG cables ................................................................. 113
5.5 Checking NIBP cuff and NIBP connecting tube ........................... 116
5.6 Carrying out a function check on the printer (only with
Printing option) ..........................................................................117
6 Operation 118
6.1 Switching on the device ............................................................. 118
6.2 Switching the device off ............................................................ 119
6.3 Navigating in the device ............................................................ 119
6.4 Selecting patient group ............................................................. 120
6.5 Preparing for shock delivery ....................................................... 122
6.6 Semi-automatic defibrillation in AED mode with defibrillation
electrodes ..................................................................................130
6.7 Manual defibrillation (only with Manual defibrillation option) ..... 137
6.8 Cardioversion (only with Cardioversion option) .......................... 145
6.9 Pulse oximetry monitoring ......................................................... 157
6.10 6-lead ECG monitoring .............................................................. 164
6.11 12-lead ECG recording and assessment (only with 12-lead
ECG option) ...............................................................................170
6.12 Non-invasive blood pressure measurement (NIBP measurement) 182
6.13 Using audio alarm output .......................................................... 193
6.14 Changing the volume of the device ............................................ 194
6.15 Saving event manually in the session data set ............................ 194
6.16 Printing ECGs and reports (only with Printing option) ................. 196
6.17 Analyzing sessions ..................................................................... 205
6.18 Reprocessing the device after use .............................................. 211
6.19 Uploading data to an external device via Bluetooth®
interface (only with Bluetooth®data transmission option) ...........212
6.20 Archiving session data ............................................................... 213

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6.21 Using service data ..................................................................... 216
7 Disassembling 218
7.1 Disassembling the power supply ................................................ 218
7.2 Disassembling defibrillation electrodes/paddles and master
cable ..........................................................................................221
7.3 Disassembling pulse oximetry sensor and pulse oximetry
sensor connecting cable .............................................................222
7.4 Disassembling ECG cable .......................................................... 224
7.5 Disassembling the NIBP cuff and NIBP connecting tube .............. 225
7.6 Disassembling the device from the protective transport bag
and the retaining plate ...............................................................227
7.7 Disassembling the device from the portable unit ........................ 229
8 Hygienic reprocessing 230
8.1 Intervals .................................................................................... 232
8.2 Preparing hygienic reprocessing ................................................. 232
8.3 Cleaning parts manually ............................................................ 233
8.4 Disinfecting parts by wiping ....................................................... 236
8.5 Subjecting bags to hygienic reprocessing ................................... 238
8.6 Preparing parts for reuse ........................................................... 238
8.7 Cleaning and disinfection plan ................................................... 240
9 Application menu 248
9.1 Navigating the application menu ............................................... 248
9.2 Menu structure .......................................................................... 249
9.3 Settings .................................................................................... 250
10 User menu 252
10.1 Navigating the user menu ......................................................... 252
10.2 Menu structure .......................................................................... 254
10.3 Settings .................................................................................... 255
11 Alarms and faults 268
11.1 General instructions .................................................................. 268
11.2 Alarm messages ........................................................................ 271
11.3 Faults ........................................................................................ 278

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12 Configuration by the operator 290
12.1 Enabling options ....................................................................... 290
12.2 Pair printer with device (only with Printing option) ..................... 290
12.3 Configuring default network ...................................................... 292
12.4 Registering the device with WEINMANN Connect ...................... 298
12.5 Configuring e-mail delivery 12-lead ECG (only with E-mail
delivery 12-lead ECG option) ......................................................299
12.6 Pairing the device with an external device via the
Bluetooth®interface (only with Bluetooth®data transmission
option) .......................................................................................302
12.7 Transferring the device configuration to another device .............. 303
12.8 Carrying out a software update ................................................. 304
13 Operator menu 306
13.1 Activating the operator menu .................................................... 307
13.2 Navigating the operator menu ................................................... 309
13.3 AED settings ............................................................................. 310
13.4 Alarm settings ........................................................................... 314
13.5 Manual mode settings (only with Manual defibrillation
option) .......................................................................................321
13.6 ECG settings ............................................................................. 324
13.7 SpO2settings ............................................................................ 327
13.8 NIBP settings ............................................................................ 329
13.9 Printer settings (only with Printing option) ................................. 332
13.10 12-lead ECG settings (only with 12-lead ECG option) ................. 335
13.11 Communication settings ............................................................ 338
13.12 System settings ......................................................................... 342
13.13 Device information .................................................................... 349
14 Maintenance 352
14.1 General instructions .................................................................. 352
14.2 Intervals .................................................................................... 352
14.3 Sending in the device ................................................................ 353
15 Storage 354
15.1 Storing the device ...................................................................... 354

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15.2 Storing the battery .................................................................... 355
15.3 Storing printer ........................................................................... 356
15.4 Storing printer battery ............................................................... 356
16 Disposal 357
16.1 Electronic waste ........................................................................ 357
16.2 Battery/printer battery ............................................................... 358
16.3 Plastics ..................................................................................... 358
16.4 Contaminated parts .................................................................. 358
17 Scope of supply 359
17.1 Version supplied (example) ........................................................ 359
17.2 Accessories and other parts ....................................................... 360
18 Technical data 367
18.1 Device ....................................................................................... 367
18.2 Defibrillation electrodes ............................................................. 370
18.3 Paddles ..................................................................................... 370
18.4 Master cable ............................................................................. 371
18.5 Battery ...................................................................................... 371
18.6 Power supply unit and charger .................................................. 371
18.7 Charging station ....................................................................... 372
18.8 Printer and printer paper ........................................................... 372
18.9 CARDIObiphasic defibrillation system ......................................... 374
18.10 6-lead ECG monitoring/12-lead ECG recording and
assessment ................................................................................375
18.11 CARDIOlogic ECG analysis system ............................................. 376
18.12 Pulse oximetry monitoring ......................................................... 379
18.13 Non-invasive blood pressure measurement (NIBP monitoring) .... 380
18.14 Operation/data management ..................................................... 380
18.15 Alarm delay times ..................................................................... 381
18.16 Saving of session data ............................................................... 382
18.17 Electromagnetic compatibility (EMC) .......................................... 382
18.18 The CARDIObiphasic shock pulse ............................................... 386
19 Labeling 389

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20 Warranty 393
21 EC Declaration of Conformity on Medical
Devices 393

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1 Introduction
1 Introduction
1.1 About this document
This document describes all possible versions of the device.
Depending on the version purchased, it may be that you do not
have available all the functions, components, and accessories
described in this document and shown in the illustrations.
If functions of the device can only be enabled by purchasing a
specific option, this document makes this clear by appending
“(optional)” and “(only with option XXXX)” to the text.
Illustrations in these instructions for use are for general
understanding, and may differ from the actual version. No claims
can be brought on the basis of any deviations.
Texts shown in the device display appear in this document in bold.
Example: Press the Charge function button.
The voice prompts of the device are shown in italics in this
document. Example: Stand clear of the patient.

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1 Introduction
1.2 Explanation of warnings
1.3 Description of function
The device offers the following monitoring and diagnostic
functions:
• 6-lead monitoring ECG: The electrical activity of the heart is
derived and displayed. This allows the user to interpret cardiac
rhythms and heart rate. To do so, the 6-lead monitoring ECG
derives the limb leads according to Einthoven (I, II, III) and
according to Goldberger (aVR, aVL, aVF) and displays these in
a curve view.
• 12-lead ECG: The electrical activity of the heart is derived and
displayed. This allows the user to carry out differentiated ECG
diagnosis. The 12-lead ECG derives the following leads for this
purpose:
• Limb leads acc. to Einthoven (I, II, III)
• Limb leads acc. to Goldberger (aVR, aVL, aVF)
• Chest wall leads acc. to Wilson (V1 to V6)
Danger!
DANGER indicates a dangerous situation which will result in death
or serious injury if not prevented.
Warning!
WARNING indicates a dangerous situation which may result in
death or serious injury if not prevented.
Caution!
CAUTION indicates a dangerous situation which may result in
minor injury if not prevented.
Notice!
NOTICE indicates risks which may possibly cause material or
environmental damage.
Designates useful tips relating to a particular sequence of actions.

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1 Introduction
• Pulse oximetry: Pulse oximetry monitoring allows continuous,
non-invasive measurement of arterial oxygen saturation with
the aid of different pulse oximetry sensors for different
application sites. At the same time, a photosensor in the pulse
oximetry sensor registers the percentage of oxygenated
hemoglobin in the arterial blood (SpO2) using different light
wavelengths. In addition, the pulse oximetry sensor registers
pulse rate. The values for SpO2and pulse rate are shown in the
display numerically, the plethysmogram in the form of a curve.
• Non-invasive blood pressure measurement (NIBP monitoring):
NIBP monitoring allows measurement of blood pressure on a
limb in adults, children, and infants. Measurement is based on
oscillometric blood pressure measurement technology. After
the measurement has been carried out, systolic and diastolic
blood pressures are shown numerically in the display in mmHg.
The device has the following therapy functions:
• Manual defibrillation and cardioversion: Based on the
information displayed by the ECG, the user decides whether it
is necessary to deliver a shock. If a shock is necessary, the user
can select the shock energy, charge the device for shock
delivery, and trigger the shock manually.
• Semi-automatic defibrillation: In AED mode, the device guides
the user through resuscitation by means of audio and visual
instructions. The device determines the resuscitation sequence.
The device automatically carries out an ECG analysis and, if
necessary, charges for electric shock delivery. The shock is
triggered manually by the user.

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2 Safety
2 Safety
The instructions for use are part of the device. If the instructions for
use and the following safety instructions are not followed in their
entirety, therapy may fail or be put at risk. This may cause the
patient, the user, and bystanders serious or life-threatening injury.
Follow instructions for use in their entirety.
Keep the instructions for use accessible and near the device at
all times.
Use the device only for the intended purpose (see “2.1
Intended purpose”, page 11).
Do not use the device if it is contra-indicated.
Follow the instructions for use of the components and
accessories.
2.1 Intended purpose
MEDUCORE Standard2is used as a mobile external defibrillator
with monitoring functions on patients who are exhibiting
symptoms of a cardiac arrest or cardiac arrhythmias.
MEDUCORE Standard2is also used when measured values of the
measuring functions integrated in the device are to be recorded.
Patient target groups
MEDUCORE Standard2is suitable for use with emergency patients
of any age (exception: semi-automatic defibrillation only from 1
year old upwards).
Intended users
Qualified medical personnel

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Contra-indications
• Defibrillation may not be carried out on patients with a body
temperature < 27 °C.
• Defibrillation may not be carried out on patients suffering
ventricular tachycardia with a pulse.
• Cardioversion may not be carried out on patients who have
overdosed on digitalis.
2.2 Intended areas of application
• Mobile use in emergency medicine or primary care in
emergency response
• Transport between hospital rooms and departments
• Transport between hospitals and other premises by
ambulance, aircraft, helicopter or ship
2.3 Possible side effects/complications
• Electrostimulation may cause burns, skin irritation and
arrhythmias.
• Electrostimulation may damage implanted medical devices or
those connected to the patient externally.

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2 Safety
2.4 Exclusions and limitations of the
intended purpose
The device has not been approved for the following applications:
• Operation in hyperbaric chambers
• Operation in conjunction with magnetic resonance imaging
machines (MRI, MRT, NMR)
• Operation in conjunction with high-frequency electrosurgical
equipment
• Electrostimulation in an electrically conductive and damp
surroundings
• Electrostimulation in an oxygen-enriched atmosphere with
simultaneous presence of combustible materials
• Electrostimulation in an atmosphere with flammable gases
2.5 Requirements on the user
The user must meet the following requirements:
• The user is medically trained and has the necessary technical
knowledge and experience in the emergency medical
treatment of patients.
• On the basis of this technical knowledge and experience, the
user is in a position to perform the tasks assigned to him or her
safely, and independently to recognize, assess and avoid
potential risks to him or herself, to the patient or to bystanders.
• The user has been trained and has received instruction in the
use of the device.
• The user is trained in extended measures to treat emergency
patients and is able to use manual mode, cardioversion and
interpretation of 12-lead ECGs as a function of the options
purchased.

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2.6 Safety information
2.6.1 Qualification
Warning Risk of injury due to lack of knowledge and failure to follow
guidelines!
Use of the device by users without medical qualifications and
training in defibrillation/cardioversion and/or the failure to follow
guidelines may result in injury to the patient, user or bystanders.
Only use the device if the user meets the requirements on the
user (see “2.5 Requirements on the user”, page 13).
Only use the device if the user is familiar with defibrillation/
cardioversion and the operation of the device.
Only use the device if the user is familiar with the enabled
options.
Follow currently applicable guidelines on defibrillation/
cardioversion.
Observe national and regional provisions on defibrillation/
cardioversion.
Observe organizational guidelines on defibrillation/
cardioversion.
Include the patient condition when deciding on treatment.
2.6.2 How to use the device
Warning Risk of injury if the device, components, and accessories are
used in damp or electrically conductive surroundings!
Using the device, components, and accessories in damp or
electrically conductive surroundings may result in an electric shock
and injure the patient, user, and bystanders.
Only connect the device, components, and accessories in dry
surroundings.
Only use the device, components, and accessories in
surroundings that are not electrically conductive.
Keep conductive parts of the electrodes and plug connections
away from other conductive parts and the ground.

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2 Safety
Risk of injury due to ingress of liquids!
The device is only protected from water jets according to IP55
when the battery is inserted, the water jet protection for the SD
card slot is closed, the cables and the NIBP connecting tube
including NIBP cuff are connected. Ingress of liquids and dust may
damage the device, components, and accessories.
Do not immerse the device, components, and accessories in
liquids.
Only operate the device with the battery inserted.
Always close the water jet protection of the SD card slot.
Always leave cables connected.
Leave the NIBP connecting tube including NIBP cuff connected
during use.
Risk of injury from malfunctions of the device, the
components, and the accessories!
A damaged device, damaged components or damaged
accessories may injure the patient, user, and bystanders.
Only operate the device, components, and accessories if they
have no external damage.
Only operate the device, components, and accessories if the
function check has been passed.
Do not leave the device and patient unsupervised.
In the event of device failure during resuscitation: Carry out
cardiopulmonary resuscitation in accordance with currently
applicable guidelines and obtain a replacement device.
In the event of device failure during a monitoring session:
Monitor patient by monitoring breathing and taking pulse and
obtain a replacement device if required.
Risk of injury due to device being inaccessible or alarm being
hidden!
An inaccessible device or hidden alarm (alarm light, loudspeaker
and display) mean that the user may not notice alarms and
consequently react belatedly to hazardous situations. This may
delay therapy and injure the patient.
Keep the device accessible at all times.
Always keep the alarm (alarm light, loudspeaker and display)
clear.
Do not operate the device in a closed bag if this conceals the
alarms.

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Risk of injury due to alarm limits which are too high or too
low!
Alarm limits which are either too high or too low may prevent the
device triggering an alarm, thereby putting the patient at risk.
Always set alarm limits which have been adapted to the
patient.
Risk of injury due to incorrectly set parameters or too few/too
many enabled functions in the operator menu!
Incorrectly set parameters or too few/too many enabled functions
in the operator menu may result in incorrect settings in the user
menu or too limited/too extensive device functions. This may
cause critical operating situations and injure the patient.
The operator menu should only be used by operators familiar
with the settings in the operator menu and their impact on the
user menu and device functions. Otherwise use the device with
factory settings.
Adapt the device functions to the user’s know-how.
Protect the operator menu with a secure access code (at least
one letter and one number).
Risk of injury from incorrectly secured access to functions!
Too simple an access code gives the user access to functions with
which he or she is not familiar or in which he or she is not trained.
This may cause the patient or the user serious or life-threatening
injury.
Protect functions with a secure access code (at least one letter
and one number).
Risk of injury from operating the device, accessories, and
components outside the prescribed ambient conditions!
Use of the device, accessories, and components outside the
specified ambient conditions may lead to incorrect results to the
extent that the device fails, injuring the patient.
Only operate the device within the prescribed ambient
conditions (see “18 Technical data”, page 367).
Allow the device, components, and accessories to acclimatize
to operating temperature.

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2 Safety
Disrupted and failed therapy due to incorrect use of
disposables!
Reusing and reprocessing disposables might induce unpredictable
reactions as a result of aging, embrittlement, wear, thermal stress,
and chemical action. This may put the functionality and safety of
the device at risk, and cause the patient and user serious or life-
threatening injury.
Do not reuse disposables.
Do not subject disposables to hygienic reprocessing.
Risk of injury from using third-party accessories!
Accessories which have not been approved by
WEINMANN Emergency may result in explosions, electric shocks,
incorrect monitoring, impaired functions and a negative impact on
interference immunity and interference emission or lead to
material damage and injure the patient.
Only use accessories which have been approved by
WEINMANN Emergency (see “17.2 Accessories and other
parts”, page 360).
Delay in treatment due to overly loud audio output!
When the defibrillator is used in conjunction with devices with
audio output (e.g. alarm tones, voice prompts), overly loud audio
output from one device may drown out audio output from the
other device and thus delay treatment.
When using multiple devices with audio output at the same
time, set the volume on the devices to the same level.
Risk of injury and treatment delay due to imperceptible alarm
signals!
Alarm signals which are quieter than the ambient noise level
prevent alarm situations from being detected. This may result in
delayed treatment and thus in injury to the patient.
Always set device volume to be louder than ambient noise
level.
Do not stack devices.
Therapy at risk due to inadequate patient monitoring!
If the patient and the device are not observed and monitored
during therapy, delayed response by medical personnel to alarms
and faults may result in severe or life-threatening injury to the
patient and incorrect therapy.
Continuously observe and monitor the patient and device
during therapy.

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Disrupted or failed therapy due to modifications to the design
of the device or accessories!
Modifications to the design of the device may result in disrupted
or failed therapy. This may cause serious or life-threatening injury
to the patient.
Do not make any modifications to the design of the device,
components or accessories.
Risk of injury and delayed treatment from connecting the
device, the components, and the accessories to several
patients!
Connecting the device to several patients simultaneously may lead
to measured values and shock delivery being incorrectly assigned.
This may injure the patient.
Only connect the device, components, and accessories to one
patient.
2.6.3 Power information
Danger Risk of injury due to electric shock when the device is opened!
The device contains a shock capacitor. Opening the device leads
to severe injuries or death from electric shock.
Do not open the device.
The device should only be opened by WEINMANN Emergency
or by technicians authorized by WEINMANN Emergency.
Measures such as repairs and maintenance should only be
carried out by the manufacturer or by a technician expressly
authorized by it.
Warning Risk of injury due to electric shock when connecting an
incorrect power supply unit and charger to line power!
The power supply unit and charger contains a safety device to
prevent electric shock. The use of an unsuitable power supply unit
and charger may result in injury to the user.
Only operate the device on line power using the power supply
unit and charger recommended by WEINMANN Emergency.
Risk of injury due to missing, discharged or defective battery!
A missing, discharged or defective battery impedes the therapy
functions.
Carry out a function check before each use in order to check
the battery.
Always have a charged, ready-to-use spare battery on hand.

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2 Safety
No therapy due to extended storage of the battery without
recharging!
Storing the battery for an extended period of time without
recharging may result in the rapid shutdown of and irreparable
damage to the battery.
When the battery is stored in the device without a power
supply: Charge battery every 3 months (see “15.2 Storing the
battery”, page 355).
If the battery is not stored in the device: Charge batteries with
serial numbers < 20,000 every 5 months and batteries with
serial numbers ≥20,000 every 9 months (see “15.2 Storing the
battery”, page 355).
Risk of injury from damaged power supply unit and charger!
When used in emergency vehicles, the power supply unit and
charger may be damaged and fail to charge the battery properly.
This may injure the patient.
Do not use the power supply unit and charger in emergency
vehicles.
Use the power supply unit and charger only in indoor spaces.
Observe the technical data for the power supply unit and
charger (see “18.6 Power supply unit and charger”, page 371).
Disrupted or failed therapy due to removal of the battery
during shock delivery!
Removing the battery during shock delivery may cause damage to
the device and thus put therapy at risk.
Always leave the battery in the device while the device is
delivering a shock.
Risk of injury due to inaccessible power plug!
An obstructed power plug cannot be pulled out in an emergency
and may thus result in injury.
Keep the power plug and line power accessible at all times.
Risk of injury due to using the charging station in damp or
electrically conductive surroundings!
Using the charging station in damp or electrically conductive
surroundings or outside indoor areas may lead to electric shock
and injure the user.
Only use the charging station in dry surroundings.
Only use the charging station in surroundings that are not
electrically conductive.
Protect the charging station from ingress of liquids.
Only use the charging station indoors.

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Impaired readiness for use as a result of a defective power
cord or defective power supply unit and charger!
A defective power cord or a defective power supply unit and
charger prevent the battery charging in the charging station and
thus the readiness of devices operated with the battery.
Check the power cord and the power supply unit and charger
regularly.
Risk of injury from electric shock!
The contacts in the battery compartment of the charging station
are live. Touching the contacts may lead to electric shock and
injure the user.
Do not touch the contacts in the battery compartment of the
charging station.
Caution Risk of injury from touching the contacts in the battery
compartment and the patient at the same time!
The contacts in the battery compartment are live. Touching the
contacts and the patient at the same time may injure the user or
the patient.
Only operate the device with the battery inserted.
Risk of injury due to trailing power cord!
Trailing power cords are a trip hazard, which may hinder operation
and cause injuries.
During operation with line power, position the power cord so
that it does not present a hindrance.
During 12 V operation, position the power cord so that it does
not present a hindrance.
Risk of injury as a result of falsified measurement results
when the line filter is not set correctly!
An incorrectly set line filter may falsify the measurement results of
the ECG and lead to misinterpretations. This may injure the
patient.
Adapt the line filter to suit the regional power supply network.
When assessing the ECG, take account of an activated line
filter.