Weinmann MEDUCORE Standard2 Instructions For Use Manual
MEDUCORE Standard
2
Monitor/Defibrillator
Instructions for Use for Devices from Software Version 1.1
Table of Contents
3.10 Markings and symbols ................................................................. 46
Table of Contents
1 Introduction 6
1.1 Intended use ................................................................................. 6
1.2 Function ........................................................................................ 6
1.3 Operator/user qualification ............................................................ 8
1.4 Contraindications for defibrillation ................................................. 8
1.5 Side effects ................................................................................... 9
2 Safety 10
2.1 Safety information ....................................................................... 10
2.2 General instructions .................................................................... 24
2.3 Warnings in this document .......................................................... 25
3 Description 26
3.1 Overview ..................................................................................... 26
3.2 Control panel .............................................................................. 27
3.3 Display ........................................................................................ 29
3.4 Symbols on the display ................................................................ 37
3.5 Battery and battery status indicator ............................................. 39
3.6 Components ............................................................................... 41
3.7 Accessories ................................................................................. 43
3.8 Transport options ........................................................................ 45
3.9 Options ....................................................................................... 45
4 Preparation 53
4.1 Mounting the device ................................................................... 53
4.2 Connecting to a power supply ..................................................... 53
4.3 Using the rechargeable battery .................................................... 54
4.4 Connecting the trunk cable and defibrillation electrodes .............. 57
4.5 Connecting the pulse oximetry sensor .......................................... 60
4.6 Connecting the ECG cable and ECG electrodes ............................ 64
4.7 Attaching the NIBP cuff ............................................................... 68
4.8 Using the SD card ........................................................................ 73
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5 Operation 76
5.1 Switching the device on ............................................................... 76
5.2 Switching the device off .............................................................. 77
5.3 Navigating in the device .............................................................. 77
5.4 Selecting the patient group .......................................................... 78
5.5 Performing defibrillation .............................................................. 80
5.6 Performing pulse oximetry monitoring .......................................... 89
5.7 Performing ECG monitoring ......................................................... 90
5.8 Performing non-invasive blood pressure measurement (NIBP) ....... 92
5.9 Using the audio alarm output ...................................................... 97
5.10 Saving the event manually in the session data set ........................ 98
5.11 Reprocessing the device after use ................................................ 99
5.12 Saving session data/status log ................................................... 100
5.13 Analyzing sessions ..................................................................... 101
5.14 Enable options .......................................................................... 101
5.15 Transferring the device configuration to another device .............. 102
5.16 Updating the software ............................................................... 103
6 Application menu 106
6.1 Navigating the application menu ............................................... 106
6.2 Menu structure .......................................................................... 107
6.3 Settings ..................................................................................... 108
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7 User menu 109
7.1 Navigating the user menu ......................................................... 109
7.2 Menu structure .......................................................................... 110
7.3 Settings ..................................................................................... 111
8 Operator menu 116
8.1 Navigating the operator menu ................................................... 117
8.2 AED settings ............................................................................. 118
8.3 Alarm settings ........................................................................... 122
8.4 Manual mode settings (only with Manual mode option) ............. 128
8.5 ECG settings ............................................................................. 130
8.6 SpO
settings ............................................................................ 132
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10.1 Intervals .................................................................................... 148
10.2 Performing a function check ...................................................... 148
10.3 Checking the ECG cables ........................................................... 153
10.4 Checking the NIBP cuff and NIBP connecting tube ..................... 155
11.1 General instructions .................................................................. 156
11.2 Alarm messages ........................................................................ 158
11.3 Faults ........................................................................................ 165
12.1 General instructions .................................................................. 170
12.2 Intervals .................................................................................... 170
12.3 Sending in device ...................................................................... 171
8.7 NIBP settings ............................................................................ 134
8.8 System settings ......................................................................... 137
8.9 Device information .................................................................... 142
9 Hygienic reprocessing 144
9.1 General instructions .................................................................. 144
9.2 Intervals .................................................................................... 145
9.3 Hygienic reprocessing of the device ........................................... 145
10 Function check 148
11 Alarms and faults 156
12 Maintenance 170
13 Storage 172
13.1 General instructions .................................................................. 172
13.2 Storing the device ..................................................................... 172
13.3 Storing the battery .................................................................... 173
14 Disposal 174
14.1 Electronic waste ........................................................................ 174
14.2 Battery ...................................................................................... 174
15 Technical data 175
15.1 Device ....................................................................................... 175
15.2 Defibrillation electrodes ............................................................. 177
15.3 Battery ...................................................................................... 178
15.4 Power supply unit and charger .................................................. 178
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15.5 CARDIObiphasic defibrillation system ......................................... 179
15.6 ECG monitoring system ............................................................. 180
15.7 ECG analysis system CARDIOlogic .............................................. 181
15.8 Pulse oximetry monitoring ......................................................... 182
15.9 Non-invasive blood pressure (NIBP) monitoring .......................... 183
15.10 Operation/data management ..................................................... 184
15.11 Alarm delay times ...................................................................... 184
15.12 Saving of session data ............................................................... 185
15.13 Electromagnetic compatibility (EMC) .......................................... 185
15.14 The CARDIObiphasic shock impulse ........................................... 187
16 Scope of supply 190
16.1 Standard product ...................................................................... 190
16.2 Options ..................................................................................... 190
16.3 Accessories ............................................................................... 191
16.4 Replacement parts ..................................................................... 193
17 Appendix 193
17.1 Warranty ................................................................................... 193
17.2 Declaration of conformity .......................................................... 194
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1 Introduction
1 Introduction
1.1 Intended use
MEDUCORE Standard2 is a mobile external defibrillator with
monitoring functions. It is used to measure and monitor vital
parameters and for defibrillation of emergency patients.
The following monitoring and diagnostic functions are available:
• 6-lead monitoring ECG
• Pulse oximetry
• Non-invasive blood pressure measurement
The following therapy functions are available:
• Manual defibrillation
• Semi-automatic defibrillation (from age 1)
1.2 Function
The device offers the following monitoring and diagnostic
functions:
• 6-lead monitoring ECG: The electrical activity of the heart is
derived and shown on the display. This allows the user to
interpret cardiac rhythms and the heart rate. The 6-lead
monitoring ECG does this by deriving the standard (Einthoven)
limb leads (I, II, III) and augmented (Goldberger) limb leads
(aVR, aVL, aVF) and displaying them in the curve view.
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1 Introduction
• Pulse oximetry: Pulse oximetry monitoring allows continuous,
non-invasive measurement of the arterial oxygen saturation
with the aid of different pulse oximetry sensors for different
application sites. At the same time, a photo sensor in the pulse
oximetry sensor registers the percentage of oxygenated
hemoglobin in the arterial blood (SpO
) using different light
2
wavelengths. In addition, the pulse oximetry sensor registers
the pulse rate. The values for SpO
and pulse rate are shown
2
on the display numerically, the plethysmogram in the form of
a curve.
• Non-invasive blood pressure (NIBP) monitoring: NIBP
monitoring allows measurement of blood pressure on a limb in
adults, children, and infants. Safety and effectiveness have not
been proven in pregnant women. Effectiveness in neonates (up
to 28 days) has not been proven for arrhythmias.
Measurement is based on oscillometric blood pressure
measurement technology. Following performance of the
measurement, the systolic and diastolic blood pressures in
mmHg are shown numerically on the display.
The device offers the following therapy functions:
• Manual defibrillation: Based on the information of the
displayed ECG, the user decides whether it is necessary to
administer a shock. If a shock is necessary, the user can select
the shock energy, charge the device for shock delivery, and
deliver the shock manually.
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• Semi-automatic defibrillation (for patients aged 1 and
upwards): In the 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 performs an ECG analysis and, if necessary,
charges for electric shock delivery. The shock is administered
manually by the user.
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1 Introduction
1.3 Operator/user qualification
MEDUCORE Standard2 must only be used by persons who can
verify that they have the following qualifications:
• Medical qualification, including training in cardiac life support
• Training in advanced methods of treating emergency patients
using the manual mode (see "5.5.2 Manual defibrillation (only
with Manual defibrillation option)", page 86).
As the operator or user, you must be fully familiar with the
operation of this medical device. Follow the statutory requirements
for operation and use (in Germany, particularly the German
regulations governing owners/operators of medical devices
(Medizinprodukte-Betreiberverordnung)). General
recommendation: You should seek instruction on the correct
handling, use and operation of this medical device from a person
authorized by WEINMANN Emergency.
1.4 Contraindications for defibrillation
Defibrillation must only be performed in cases of:
• Ventricular fibrillation (VF)
• Pulseless ventricular tachycardia (VT)
Contraindications include:
• The patient is responsive
• The patient is breathing normally
• ECG is showing asystole
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1.5 Side effects
Possible side-effects of defibrillation are:
• Burns
• Arrhythmias triggered by defibrillation
• Ventricular fibrillation
• Failure of active implants
• Skin irritations
• Failure of external diagnostic or therapy devices
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2 Safety
2 Safety
2.1 Safety information
2.1.1 Qualification
Warning Risk of injury due to lack of knowledge and failure to follow
Read these Instructions for Use carefully. They form part of the
devices described, and must be available at all times.
Only use the device for the intended use (see "1.1 Intended use",
page 6).
For your own safety and that of your patients, and in accordance
with the requirements of Directive 93/42/EEC, please observe the
following safety instructions.
guidelines!
The use of the device by users without medical qualifications and
training in defibrillation and/or the failure to follow guidelines can
result in injury to the patient, user or bystanders.
⇒ Only use the device if the user has a medical qualification and
is familiar with defibrillation and the operation of the device.
⇒ Follow the defibrillation guidelines.
⇒ Observe national and regional provisions and organizational
defibrillation guidelines.
2.1.2 How to use the device
Warning Risk of injury if the device is used in damp or electrically
conductive surroundings!
Using the device in damp or electrically conductive surroundings
may result in an electric shock and injury to the patient, user or
bystanders.
⇒ Only use the device in a dry place.
⇒ Only use the device in surroundings that are not electrically
conductive.
⇒ Keep conductive parts of the electrodes and plugs away from
other conductive parts and the ground.
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Risk of injury due to device or component malfunction!
A damaged device or damaged components may result in injury
to the patient, user or bystanders.
⇒ Only operate the device and components if they are externally
undamaged.
⇒ Only operate the device and components if the function check
has been successfully completed.
⇒ Do not leave device and patient unsupervised.
⇒ In the event of device failure during resuscitation: Perform
cardiopulmonary resuscitation in line with the applicable
resuscitation guidelines and obtain a replacement device.
⇒ In the event of device failure during monitoring: Monitor
patient by monitoring breathing and taking pulse and obtain a
replacement device if required.
Risk of injury due to concealed alarm!
A concealed alarm light, loudspeaker and/or display will prevent
the user from noticing any alarms and reacting to dangerous
situations. This may result in injury to the patient.
⇒ Always keep the alarm (alarm light, loudspeaker and display)
free.
⇒ Do not operate the device in a closed bag if the alarms are then
concealed.
Risk of injury due to inaccessible device!
During use, the device requires the intervention of the user. An
inaccessible device may delay treatment and result in injury to the
patient.
⇒ Keep the device accessible at all times.
⇒ Position the device so that display and alarms are clearly visible
during use.
Risk of injury due to alarm limits which are too high or too
low!
Alarm limits which are either too high or too low can prevent the
device from emitting 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 can result in incorrect settings in the user
menu or too limited/too comprehensive device functions. This can
cause critical operating situations and injure the patient.
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⇒ The operator menu should only be used by operators who are
familiar with the settings in the operator menu and their
impacts 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 password.
Risk of injury from operating the device, accessories and
components outside of the prescribed ambient conditions!
Use of the device, accessories and components outside of the
prescribed ambient conditions may mean that tolerances are not
adhered to and result in device failure and injury to the patient.
⇒ Only operate the device within the prescribed ambient
conditions (see "15 Technical data", page 175).
⇒ Allow the device, components and accessories to acclimatize to
the operating temperature.
Risk of injury due to reuse of disposable items!
Disposable items are intended for single use. Disposable items
which are reused may be contaminated and/or impaired in their
function and therefore cause injury to the patient.
⇒ Do not reuse disposable items.
Risk of injury from using third-party accessories!
Accessories which have not been approved by
WEINMANN Emergency can result in electric shocks, incorrect
monitoring, negative impact on interference immunity and
emission or lead to damage to the device and injure the patient.
⇒ Only use accessories which have been approved by
WEINMANN Emergency.
Delay in treatment due to overly loud audio outputs!
When the defibrillator is used in conjunction with devices with
audio outputs (e.g. audible alarms, voice prompts), overly loud
audio outputs from one device can drown out the audio outputs
from the other device, and thus delay treatment.
⇒ When using multiple devices with audio outputs 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 can result in
treatment delays and thus to injury to the patient.
⇒ Always set the device volume to be louder than the ambient
noise level.
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⇒ Do not stack devices.
Notice Damage to the device caused by ingress of liquids!
The device is only protected from water jets as per IP55 when the
battery is inserted and the water jet protection of the SD card slot
is closed. Ingress of liquids and dust may damage the device,
components, and accessories.
⇒ Do not immerse the device, components, or accessories in
liquids.
⇒ Only operate the device with the battery inserted.
⇒ Always close the water jet protection of the SD card slot.
2.1.3 Power supply
Warning Risk of injury due to electric shock when the device is opened!
The device has a capacitor for shock energy. Opening the device
may result in electric shock and injure people.
⇒ Do not open the device.
⇒ The device should only be opened by WEINMANN Emergency
or persons 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 the latter.
Risk of injury due to electric shock when connecting an
incorrect power supply unit and charger to the 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 ECG filter not being correctly adapted to
the regional supply system!
An ECG filter which is not correctly adapted to the regional power
supply network can impair the ECG display and cause the device
to recommend a shock at the wrong point in time. This may result
in serious injury to the patient.
⇒ Adapt the ECG filter to the regional power supply network.
Risk of injury due to missing, discharged, or defective battery!
A missing, discharged or defective battery prevents treatment
functions.
⇒ Perform a function check before each use in order to check the
battery.
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⇒ Always have a charged, ready-to-use spare battery on hand.
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 can injure the user or
the patient.
⇒ Do not touch the contacts in the battery compartment and the
patient at the same time.
Risk of injury due to trailing power cord!
A trailing power cord is a trip hazard, which may cause injury and
hinder operation of the device being used.
⇒ During line operation, 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 due to inaccessible power plug!
An obstructed power plug cannot be pulled out in an emergency
and can thus result in injury.
⇒ Keep the power plug and line power accessible at all times.
Notice Damage to the device caused by removal of the battery
during shock delivery!
Removal of the battery during shock delivery can cause damage to
the device.
⇒ Always leave the battery in the device while the device is
delivering a shock.
Material damage due to prolonged storage of the battery
without recharging!
Storing the battery for a prolonged period of time without
recharging can 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 "13.3 Storing the
battery", page 173).
⇒ If the battery is not stored in the device: Charge battery every
5 months (see "13.3 Storing the battery", page 173).
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2.1.4 Defibrillation
Warning Risk of injury due to sparks during defibrillation in the
presence of oxygen and combustible materials!
During defibrillation in an oxygen-enriched atmosphere and in the
presence of combustible materials (e.g. textiles), sparks generated
by defibrillation may cause explosion and fire, which may result in
injury to the patient, user or bystanders.
⇒ When treating patients with oxygen masks, nasal tubes or
nasal cannulas: Switch off the oxygen supply or place the
inhalation points at least 1 m away from the patient during
defibrillation, and ensure that the oxygen/air mixture flows
away from the torso.
⇒ When treating patients with a resuscitator: Leave the
resuscitator securely in place on the patient tube or place it at
least 1 m away from the patient, and ensure that the oxygen/
air mixture flows away from the torso.
⇒ When connecting patients to a ventilator: Ensure that the
oxygen/air mixture coming from the exhalation valve flows
away from the torso.
⇒ When performing defibrillation in tight spaces with an oxygen-
enriched atmosphere, ensure that there is adequate
ventilation.
Risk of injury due to missing battery in the AED mode and in
manual mode!
Without a battery, the capacitor for shock energy in the device
cannot charge. This prevents defibrillation and delays treatment.
⇒ Insert a battery when using the AED mode or manual mode.
⇒ When using the AED mode or manual mode: Do not remove
the battery.
Risk of injury due to sparks during defibrillation in the
presence of flammable gases!
During defibrillation in the presence of flammable gases, sparks
may cause explosion, which may result in injury to the patient,
user or bystanders.
⇒ Do not use the device in the presence of flammable gases.
Risk of injury due to incorrect operation of the device!
Performing defibrillation on patients who are responding
normally, breathing normally or have a non-defibrillatable cardiac
rhythm will result in injury to the patient.
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⇒ Only perform defibrillation on patients who are not responding
normally, are not breathing normally and have a defibrillatable
cardiac rhythm.
Risk of injury due to unsuitable AED analysis algorithm in
children below one year of age!
The device's AED analysis algorithm is not designed for children
below one year of age and may result in injury to the child.
⇒ Do not use the AED mode on children below one year of age.
Risk of injury during resuscitation due to incorrect settings in
the operator menu!
Incorrect settings in the operator menu can result in undesirable
effects during resuscitation as well as injury to the patient.
⇒ Only allow persons with specialist knowledge of the latest
resuscitation recommendations to make settings in the
operator menu.
⇒ If you are unaware of the most recent recommendations for
resuscitation: Use the factory settings.
Delay in treatment due to movement artifacts during ECG
analysis!
Movement artifacts distort the ECG. They may result in the user or
the device incorrectly interpreting the ECG, and delay treatment.
During cardiac rhythm analysis:
⇒ Place the patient in a resting position.
⇒ Stand clear of the patient.
⇒ Do not resuscitate the patient.
⇒ Do not ventilate the patient.
⇒ Do not transport the patient.
Risk of injury due to incorrectly selected size of defibrillation
electrodes!
If the wrong size of defibrillation electrodes is selected, this can
result in sub-optimal defibrillation results or in burns.
⇒ Select the correct size of defibrillation electrodes pursuant to
the resuscitation guidelines and not based on the weight
specifications given on the packaging.
Risk of injury and delay in treatment due to incorrectly placed
defibrillation electrodes!
Incorrectly placed defibrillation electrodes may distort the ECG
and result in the user delivering an unnecessary shock, not
delivering a necessary shock or unsuccessful defibrillation on the
basis of the interpretation of an incorrect ECG.
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⇒ Place the defibrillation electrodes correctly as per the
Instructions for Use.
⇒ Always place defibrillation electrodes together on only one
person.
⇒ Prevent the defibrillation electrodes from being touched.
⇒ Keep the defibrillation electrodes away from other electrodes
and parts in contact with the patient.
Risk of injury due to air/moisture between defibrillation
electrodes and the patient's skin!
Air (e.g. in hirsute patients) or moisture between the defibrillation
electrodes and the patient's skin prevent correct shock delivery
and may result in burns to the skin and unsuccessful defibrillation.
⇒ Remove hair in hir
sute patients.
⇒ Rub the patient's skin dry.
⇒ Firmly press on the defibrillation electrodes.
Risk of injury due to non-functional defibrillation electrodes!
Non-functional defibrillation electrodes may result in injury and
unsuccessful defibrillation.
⇒ Only use defibrillation electrodes with undamaged packaging.
⇒ Do not use defibrillation electrodes with a dry gel layer,
damage or detached protective film.
⇒ Replace damaged defibrillation electrodes.
⇒ Observe the expiry date of the defibrillation electrodes and, if
necessary, replace the defibrillation electrodes.
⇒ Dispose of defibrillation electrodes after use, and do not reuse
them.
⇒ Only use defibrillation electrodes approved by
WEINMANN Emergency for the device.
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Risk of injury and delay in treatment due to implanted cardiac
pacemakers!
Impulses from implanted cardiac pacemakers may affect the
detection of defibrillatable cardiac rhythms, and delay treatment.
Performing defibrillation on patients with implanted cardiac
pacemakers may irreversibly damage the myocardium.
⇒ Position defibrillation electrodes at least 8 cm away from
cardiac pacemakers.
⇒ Choose alternative positions (e.g. anterior-lateral, anterior-
posterior) for the defibrillation electrodes.
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Risk of injury due to ECG misinterpretation if ECG is derived
from the defibrillation electrodes!
If the ECG is derived from the defibrillation electrodes, the device
shows a non-diagnostic ECG curve. The ECG curve is designed to
detect shockable cardiac rhythms and is not suitable for
differential diagnostics. This can result in ECG misinterpretation,
and thus in injury to the patient.
⇒ Do not use ECGs derived from defibrillation electrodes for
differential diagnosis.
Delay in treatment due to simultaneous voice prompts from
defibrillator and ventilator!
If the defibrillator in AED mode is used in conjunction with a
ventilator (MEDUMAT Easy CPR) which also guides the user
through cardiopulmonary resuscitation by means of voice
prompts, the simultaneous voice prompts from defibrillator and
ventilator may confuse the user, and delay treatment.
⇒ When using the defibrillator in AED mode and a ventilator at
the same time, switch off the ventilator voice prompts.
Risk of injury and treatment delay from connecting the device
to several patients!
Connection of the device to several patients may result in the ECG
being misinterpreted and thus to unsuccessful defibrillation. This
can injure the patient.
⇒ Only connect the device, components and accessories to one
patient.
Notice Damage to the device caused by the delivery of defibrillation
energy!
The charging and delivery of defibrillation energy may interfere
with the functioning of other electrical devices or damage devices
connected to the patient or in the vicinity of the defibrillator.
⇒ Disconnect from the patient any electrical devices without
defibrillation protection.
⇒ After using the defibrillator, check the function of the electrical
devices in its vicinity.
⇒ Maintain separation distances between the defibrillator and
portable and mobile radio-frequency communications devices.
Damage to the device caused by removal of the defibrillation
electrodes during shock delivery!
Removal of the defibrillation electrodes during shock delivery can
cause damage to the device.
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⇒ Always leave defibrillation electrodes connected to the device
during shock delivery.
2.1.5 ECG monitoring
Warning Risk of injury from incorrect, expired or damaged ECG
electrodes!
Incorrect, expired or damaged ECG electrodes impair the quality
of the ECG signal and falsify measurements. This can injure the
patient.
⇒ Use ECG electrodes WM 45201 which have been approved by
WEINMANN Emergency. If this is not possible: Only use ECG
electrodes which satisfy all the of the following points.
⇒ Only use ECG electrodes as per AAMI EC 12.
⇒ Only use high-quality ECG electrodes.
⇒ Observe the expiry date of the ECG electrodes and, if necessary,
replace the ECG electrodes.
⇒ Only use ECG electrodes with undamaged packaging.
⇒ Do not use ECG electrodes with a dry gel layer, damage or
detached protective film.
⇒ Do not remove ECG electrodes from the packaging until
directly before use.
⇒ Replace damaged ECG electrodes during use.
⇒ Do not use ECG electrodes for defibrillation.
⇒ Dispose of ECG electrodes after use, and do not reuse them.
Risk of injury from using the 6-lead ECG for more in-depth
diagnostics!
The ECG curve of the 6-lead ECG is not suitable for differential
diagnostics (e.g. infarction diagnostics). This can result in ECG
misinterpretation, and thus in injury to the patient.
⇒ Do not use the 6-lead ECG for differential diagnostics.
⇒ Additionally, use a 12-lead diagnostics ECG device for
differential diagnostics.
Risk of injury and delay in treatment due to implanted cardiac
pacemakers!
In the case of patients with cardiac pacemakers, the device detects
the pacemaker impulses and suppresses the heart rate display and
heart rate alarms. This may result in injury to the patient.
⇒ Monitor patients with pacemakers very closely.
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Caution Risk of injury due to ECG malfunction in the vicinity of
electrosurgical devices!
ECG functions may be affected by electrosurgical devices and
result in injury to the patient.
⇒ Only use approved ECG cables.
Risk of injury from burns during defibrillation!
ECG cables without defibrillation protection may result in injury to
the patient.
⇒ Only use approved ECG cables.
2.1.6 Pulse oximetry monitoring
Caution Risk of injury due to overly high pulse oximetry sensor contact
pressure!
High pulse oximetry sensor contact pressure over an extended
period of time can cause poor circulation or changes to the skin
and injury to the patient.
⇒ Do not attach the pulse oximetry sensor too tightly.
⇒ Check the pulse oximetry sensor every 4 hours and, if
necessary, reposition it.
⇒ Reposition the pulse oximetry sensor in the case of skin
changes.
Risk of injury from using the pulse oximetry sensor at high
temperatures!
At temperatures of > 41°C, the skin can be damaged from high
contact pressures causing injury to the patient.
⇒ Do not apply excessive pressure when attaching the pulse
oximetry sensor.
⇒ If necessary: Shorten the application time of the pulse oximetry
sensor.
Risk of injury due to incorrect use of the pulse oximetry
sensor!
The incorrect use of the pulse oximetry sensor may produce false
readings, and result in injury to the patient.
⇒ Keep the pulse oximetry sensor away from strong
electromagnetic sources (e.g. electrosurgical devices).
⇒ Do not use the pulse oximetry sensor in radiological areas
(e.g. with MRI devices).
⇒ Keep the pulse oximetry sensor away from strong and
fluctuating ambient light (including infrared and UV light). If
necessary: cover.
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2 Safety
⇒ Avoid strong movement of the pulse oximetry sensor. If
necessary: To relieve strain, loop the pulse oximetry sensor
cable and the pulse oximetry sensor connecting cable and fix to
the patient with a plaster.
⇒ Do not attach the pulse oximetry sensor to a limb on which
there is already an NIBP sleeve or catheter port.
⇒ Keep the pulse oximetry sensor away from nail polish and
artificial fingernails.
⇒ Keep the pulse oximetry sensor away from intravascular dyes.
⇒ Beware inaccurate readings in the case of elevated levels of
dysfunctional hemoglobins.
⇒ Note deviations from the measurement result in the case of
serious anemia, venous pulsation and high total bilirubin
values.
⇒ Note deviations from the pulse rate with an intra-aortic balloon
pump or certain arrhythmias.
If necessary: Compare the pulse rate with the heart rate
determined by ECG monitoring.
⇒ Note deviations from the measurement result during
defibrillation.
⇒ Only use undamaged pulse oximetry sensors.
⇒ Only use the pulse oximetry sensors and pulse oximetry sensor
connecting cables contained in the scope of supply and
mentioned in the accessories.
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2.1.7 Non-invasive blood pressure (NIBP) monitoring
Warning Risk of injury due to incorrect NIBP cuff!
An incorrectly selected or used NIBP cuff can lead to patient
injuries.
⇒ Attach the NIBP cuff so that the blood supply is not stopped.
⇒ Do not attach the NIBP cuff to a limb with an intravenous
infusion.
⇒ Do not attach the NIBP cuff to a limb with a shunt.
⇒ Do not attach the NIBP cuff to a limb with open wounds or
burns.
⇒ In the case of patients who have undergone a mastectomy, do
not attach the NIBP cuff to the affected side. In the case of
patients who have undergone double mastectomies, attach
the NIBP cuff to the non-dominant arm.
⇒ Do not attach the NIBP cuff to a limb with poor circulation.
MEDUCORE Standard
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EN 21
2 Safety
Caution Risk of injury from falsified measurement results during non-
invasive blood pressure monitoring!
An incorrectly selected or used NIBP cuff can falsify the results and
lead to patient injuries.
⇒ Always use the NIBP cuff which is best suited to the patient’s
limb. Selecting the right NIBP cuff is vital to ensuring goodquality results.
⇒ Attach the NIBP cuff level with the heart.
⇒ Avoid moving the NIBP cuff during NIBP measurements.
⇒ Do not bend or crush the NIBP cuff and the NIBP connecting
tube.
⇒ Repeat the NIBP measurement if the results appear
questionable. If the results of the repeated measurement are
still questionable, select an alternative method.
⇒ Do not attach the NIBP cuff to a limb on which there is already
a pulse oximetry sensor or another monitoring device.
⇒ Only use undamaged NIBP cuffs.
⇒ Only use the NIBP cuffs and NIBP connecting tubes contained
in the scope of supply and mentioned in the accessories.
⇒ Follow the Instructions for Use for the NIBP cuff
Risk of injury from overly frequent measurements
Overly frequent measurements can lead to circulation problems
and patient injury.
⇒ Select the measurement intervals so that sufficient perfusion is
guaranteed.
⇒ With long-lasting NIBP measurements, check the position of
the NIBP cuff regularly and, if necessary, reposition it
2.1.8 Electromagnetic compatibility
Warning Risk of injury from mutual influence of medical electrical
devices!
Medical electrical devices which are operated directly next to or on
top of each other can cause mutual interference to functionality
and thus patient injury.
⇒ Do not stack the device with other medical electrical devices.
⇒ Do not operate the device in the direct vicinity of other medical
electrical devices (exception: Approved combinations of
devices for MEDUCORE Standard
from WEINMANN Emergency).
22 EN MEDUCORE Standard
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on the portable systems
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2 Safety
⇒ If stacking or operation in the immediate vicinity cannot be
avoided: Closely monitor the functioning of all affected
medical electrical devices and do not use if functions are
disrupted.
Risk of injury from increased interference emissions or
reduced interference immunity!
Electronic accessories such as cables, sensors and power supply
units and chargers influence electromagnetic interference
emissions and immunity and can lead to malfunctioning of the
device or other medical electrical devices. This can injure the
patient.
⇒ Only use the articles defined by WEINMANN Emergency in the
scope of supply and accessories.
Risk of injury from portable radio-frequency communication
devices in the immediate vicinity of the device!
Portable radio-frequency communication devices (e.g. mobile
radios, antennae and antenna cables) in the direct vicinity of the
device can influence the functioning of the device and injure the
patient.
⇒ With portable radio-frequency communication devices,
maintain a minimum distance of 30 cm to the device,
components and accessories.
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Caution Delay in treatment due to interference caused by
electromagnetic fields!
Electromagnetic fields can impair the functioning of the device.
This can lead to incorrect analysis results, false measurements and
false alarms and thus delay treatment.
⇒ Maintain separation distances (see "15 Technical data", page
175).
Delay in treatment due to power supply network faults!
Transient or pulsed conducted interferences may cause the device
to malfunction. This can lead to false measurements and false
alarms and thus delay treatment.
⇒ If there is major interference in the power supply network, only
operate the device with a battery.
MEDUCORE Standard
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EN 23
2 Safety
2.2 General instructions
• If third-party items are used, malfunctions may occur and
fitness for use may be restricted. Biocompatibility requirements
may also not be met. Please note that in such cases, any
warranty claim and liability will be voided if neither the
accessories recommended in the Instructions for Use nor
original replacement parts are used. Third-party items may
increase the radiation output or reduce the interference
immunity.
• Repairs, servicing and maintenance should only be carried out
by the manufacturer WEINMANN Emergency or by a
technician expressly authorized by the latter.
• The manufacturer, WEINMANN Emergency, guarantees the
compatibility of the device and all components or accessories
connected to the patient prior to use. Only have modifications
to the device (exception: software update) carried out by the
manufacturer, WEINMANN Emergency, or by a technician
expressly authorized by the latter. Do not use any articles from
third parties.
• Any constructive changes made to the device may put the
patient and the user at risk and are not permitted.
• The power supply unit and charger is not intended for use in
vehicles or outdoors. Only use the power supply unit and
charger in closed rooms and observe the technical data (see
"15 Technical data", page 175).
• Please observe the section on hygienic reprocessing in order to
avoid infection or bacterial contamination (see "9 Hygienic
reprocessing", page 144).
• Also follow the respective Instructions for Use for the
components and the accessories.
• Always carry out a function check before using the device (see
"10 Function check", page 148).
• Risks due to software errors have been minimized by means of
extensive qualification measures.
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• This device’s software contains code which is subject to the
General Public License (GPL). You will receive the source code
and the GPL upon request.
2.3 Warnings in this document
Warnings are used to flag up safety-relevant information.
You will find a warning preceding any action that entails a hazard
for persons or equipment.
Warnings consist of
• the warning symbol (pictogram),
• a signal word designating the hazard level,
• information about the hazard, and
• instructions for avoiding the hazard.
The warnings appear in three hazard levels depending on the
degree of danger:
Danger!
Designates an extremely dangerous situation. Failure to observe
this warning may lead to serious,
irreversible injury or death.
2 Safety
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Warning!
Designates an extremely dangerous situation. Failure to observe
this warning may lead to serious, irreversible or fatal injury.
Caution!
Designates a dangerous situation. Failure to observe this warning
may lead to minor or moderately serious injury.
Note!
Indicates a harmful situation. Failure to observe this warning may
lead to damage to equipment.
Designates useful information relating to a particular action.
MEDUCORE Standard
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EN 25
3 Description
13
10 928
11
76
45
3 Description
3.1 Overview
3-1 Device
No. Designation Description
1 ECG connection for ECG cable Connects the device to the ECG cable.
2 Display
3 Alarm light Indicates high-priority alarms visually.
4 Power supply connection Connects the device to the power supply.
5 Security seal
6 Loudspeaker
7 SD card slot For inserting an SD card.
8 Pad connection for trunk cable
port for pulse oximetry sensor
SpO
9
26 EN MEDUCORE Standard
2
connecting cable
Displays settings and current values (see "3.4 Symbols
on the display", page 37).
Indicates whether the device has been opened without
authorization.
Emits audible voice prompts, alarms and heart rate
tones/pulse tones.
Connects the device via the trunk cable to the
defibrillation electrodes and the function test resistor.
Connects the device to the pulse oximetry sensor via
the pulse oximetry sensor connecting cable.
2
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No. Designation Description
1
2
3
7
5
6
12
10
11
8
9
4
10 Connection for NIBP connecting tube
Connects the device to an NIBP cuff via the NIBP
connecting tube.
11 Battery compartment with battery Houses the battery.
3.2 Control panel
3 Description
3-2 Controls
No. Designation Description
1 Line power indicator Indicates that the device is connected to line power.
• Steady green light: The battery is full or is not
being charged because it is outside the charging
2 Battery status indicator
temperature range.
• Flashing green light: The battery is being charged.
• Steady red light: The battery is defective or not in
the device.
• No light: The device is not connected to line
power.
3 Shock button Delivers an electric shock for defibrillation.
4 Shock standby indicator
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Flashing red light when the device is ready to deliver a
shock.
MEDUCORE Standard
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EN 27
3 Description
No. Designation Description
• Pauses the audio alarm output for a certain length
of time.
5 Alarm button
• Mutes the audio alarm output.
• Cancels audio alarm outputs.
• Deactivates muting of the audio alarm output and
alarm cancellation.
• In the start menu: Provides access to the operator
6 Menu button
menu.
• In a mode: Provides access to the user menu.
• Allows values to be selected (by turning).
7 Navigation knob
• Confirms selected values (by pressing).
• In a mode: Provides access to the application
menu (by pressing).
8 On/Off button Switches the device on or off.
• Provide access to the mode shown on the display.
9 Function buttons
• Activate/deactivate the functions shown on the
display.
• Activates the NIBP function mode (press NIBP
10 NIBP button
button < 2 s)
• Starts an NIBP measurement (press NIBP button
for >2s)
11 Event button Manually saves an event in the data set.
Switches between the following views:
12 View button
• Parameter view
• Curve view
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3.3 Display
12
4
5
6
3
3.3.1 Start menu
3-3 Start menu display
3 Description
No. Designation Description
1 Battery status Displays the charge level of the battery.
2 Time Displays the time.
3 Service reminder (if activated) Displayed when the service interval is ≤ 30 days.
4 Patient groups
5 Function check Provides access to the function check.
6 SD card indicator Indicates the status of the SD card.
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Starts the device with the presets specific to the
patient groups.
MEDUCORE Standard
2
EN 29
3 Description
123 45 7
8
9
13612 11
19
17
16
15
10
14
20
21
18
3.3.2 AED mode
3-4 Display in AED mode: Parameter view (top) and curve view
(bottom)
No. Designation Description
1 Battery status Displays the charge level of the battery.
2 Time Displays the time.
3 Session duration Displays the duration of the current session.
4 Number of shocks delivered
Displays the number of shocks delivered during the
current session.
5 Shock energy Shows the selected shock energy for the next shock.
30 EN MEDUCORE Standard
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WM 68201 12/2017
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