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
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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• 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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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.
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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
2
on the portable systems
WM 68201 12/2017
2
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.
WM 68201 12/2017
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
2
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.
24 EN MEDUCORE Standard
WM 68201 12/2017
2
• 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
WM 68201 12/2017
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
2
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
WM 68201 12/2017
Flashing red light when the device is ready to deliver a shock.
MEDUCORE Standard
2
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
28 EN MEDUCORE Standard
WM 68201 12/2017
2

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.
WM 68201 12/2017
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
2
WM 68201 12/2017
No. Designation Description
Shows the selected patient group:
6 Patient group
• for adults
•Child
7 Mode indicator Indicates the currently selected mode. 8 Alarm limits Displays the set alarm limits.
9 Alarm off indicator
10 AED instructions
Shows whether the alarm output is deactivated in AED mode.
Give instructions on performing cardiopulmonary resuscitation.
Switches the metronome algorithm between two settings:
11 Metronome switch
• 15:2 /30:2:
15/30 chest compressions with 2 mechanical breaths
• Intub.: Continuous chest compression
12 Monitor mode Provides access to the monitor mode.
13
14 ECG calibration mark
Manual mode (only with Manual defibrillation option)
Provides access to the manual mode.
Shows the curve corresponding to 1 mV of the ECG signal.
15 NIBP Shows blood pressure. 16 Pulse Shows the pulse rate. 17 SpO
2
Shows the oxygen saturation.
18 Middle curve field Shows the plethysmogram. 19 HR Shows the heart rate. 20 Top curve field Displays the ECG lead (pad, II). 21 SD card indicator Indicates the status of the SD card.
3 Description
WM 68201 12/2017
MEDUCORE Standard
2
EN 31
3 Description
12 345 78 9
24
15 14 13
18
16
23
22
21
19
20
10
11
12
6
17
3.3.3 Manual mode
3-5 Display in manual mode
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 Elapsed time since last defibrillation
5 Number of shocks delivered
6 Shock energy Shows the selected shock energy for the next shock.
7 Alarm indicator
8 Patient group
9 Mode indicator Indicates the currently selected mode. 10 Top curve field Shows the ECG lead (Pad, II). 11 Middle curve field Displays selected ECG lead (I, II, III, aVR, aVL or aVF). 12 Bottom curve field Shows the plethysmogram. 13 Energy Allows the shock energy to be set.
32 EN MEDUCORE Standard
Displays the elapsed device time since the last defibrillation.
Displays the number of shocks delivered during the current session.
Indicates the status of the audio alarm output:
• Audio alarm output active
• Audio alarm output muted/paused
• Audio alarm output canceled
Shows the selected patient group:
• for adults
•Child
•Infant
2
WM 68201 12/2017
No. Designation Description
Enables the user to select the type of ECG lead
14 ECG lead selection
displayed in the middle curve field (I, II, III, aVR, aVL or aVF).
15 Monitor mode Provides access to the monitor mode. 16 Charging Charges the defibrillation capacitor.
17 ECG calibration mark
Shows the curve corresponding to 1 mV of the ECG signal.
18 AED mode Provides access to the AED mode. 19 NIBP Shows blood pressure. 20 Alarm limits Displays the set alarm limits. 21 Pulse Shows the pulse rate. 22 SpO
2
Shows the oxygen saturation.
23 HR Shows the heart rate. 24 SD card indicator Indicates the status of the SD card.
3 Description
WM 68201 12/2017
MEDUCORE Standard
2
EN 33
3 Description
12
28
45 6
7
3
25
17
16
14 12
11
13
9
8
23
26
24
22
21
20
19
18
27
10
15
3.3.4 Monitor mode
3-6 Display in monitor mode: Parameter view (top) and curve
No. Designation Description 1 Battery status Displays the charge level of the battery.
view (bottom)
2 Time Displays the time.
Indicates the status of the audio alarm output:
4 Alarm indicator
34 EN MEDUCORE Standard
• Audio alarm output active
• Audio alarm output muted/paused
• Audio alarm output canceled
2
WM 68201 12/2017
3 Description
No. Designation Description
Shows the selected patient group:
5 Patient group
• for adults
•Child
•Infant
6 Mode indicator Indicates the currently selected mode. 7 Alarm limits Displays the set alarm limits.
8 History
Shows the time and values of the last NIBP measurements.
9 Top curve field Shows the ECG lead (Pad, II). 10 Middle curve field Displays selected ECG lead (I, II, III, aVR, aVL or aVF). 11 Bottom curve field Shows the plethysmogram. 12 Heart rate tone/pulse tone Switches the heart rate tone/pulse tone on and off.
Enables the user to select the type of ECG lead
13 ECG lead selection
displayed in the middle curve field (I, II, III, aVR, aVL or aVF).
14 ECG lead Displays selected ECG lead (I, II, III, aVR, aVL or aVF).
15
16 ECG calibration mark
Manual mode (only with Manual defibrillation option)
Provides access to the manual mode.
Shows the curve corresponding to 1 mV of the ECG signal.
17 AED mode Provides access to the AED mode. 18 NIBP Shows blood pressure. 19 Pulse Shows the pulse rate. 20 SpO
2
Displays the SpO2 curve (plethysmogram).
21 HR Shows the heart rate.
22 Duration of venous stasis
Shows the time during which the NIBP cuff maintains a venous stasis.
Shows the time between two consecutive NIBP
23 Interval duration
measurements when measurements are taken at intervals.
24 Initial NIBP cuff pressure
25 Alarm limits
26 SYS
27 DIA
Shows the pressure to which the device initially inflates the NIBP cuff.
Shows the alarm limits for the systolic and diastolic measured values.
Shows the systolic value following an NIBP measurement.
Shows the diastolic value following an NIBP measurement.
28 SD card indicator Indicates the status of the SD card.
WM 68201 12/2017
MEDUCORE Standard
2
EN 35
3 Description
1
23456
7
8
9
10
11
3.3.5 NIBP function mode
3-7 Display in monitor mode with superimposed NIBP function
mode
No. Designation Description
1 History
2 Start/stop
3 iv Starts venous stasis.
4 Duration of venous stasis
5 Interval
6 Interval duration
7 Initial Allows the initial NIBP cuff pressure to be changed.
8 Initial NIBP cuff pressure
Shows the time and values of the last three NIBP measurements.
• Starts or stops an NIBP measurement.
• Starts or stops an interval measurement.
• Stops venous stasis.
Shows the time during which the NIBP cuff maintains a venous stasis.
• Specifies whether the NIBP measurement is an individual NIBP measurement or an interval measurement.
• Specifies the time between two consecutive NIBP measurements when measurements are taken at intervals.
Shows the time between two consecutive NIBP measurements when measurements are taken at intervals.
Shows the pressure to which the device will inflate the NIBP cuff at the next NIBP measurement.
WM 68201 12/2017
36 EN MEDUCORE Standard
2
3 Description
No. Designation Description
9 Alarm limits
10 SYS Shows the systolic value with an NIBP measurement. 11 DIA Shows the diastolic value with an NIBP measurement.
Shows the alarm limits for the systolic and diastolic measured values.

3.4 Symbols on the display

Symbol Designation Description
Battery status symbol Battery status
SD card in SD card slot
• No SD card in SD card slot
SD card symbol
• SD card defective/not formated
•SD card full
Saving data to SD card
WM 68201 12/2017
Alarm symbol
Patient group symbol
Audio alarm output active
Audio alarm output canceled
Audio alarm output paused for the time set in the operator menu
Audio alarm output muted with no time limit
Alarm output deactivated in AED mode
Infant patient group
Child patient group
Adult patient group
MEDUCORE Standard
2
EN 37
3 Description
Symbol Designation Description
Heart rate tone/pulse tone function button
Function check symbols
Cardiac symbol
Signal bar
Heart rate tone/pulse tone on
Heart rate tone/pulse tone off
Requirements for function check met
Requirements for function check not met
Fault found during function check
Follow Instructions for Use
Service interval exceeded
• In the HR parameter field: Flashes at the measured heart rate.
• In the SpO
parameter field: Flashes at the
2
measured pulse rate.
Shows the signal quality of the SpO
2
measurement.
38 EN MEDUCORE Standard
WM 68201 12/2017
2

3.5 Battery and battery status indicator

12 3 4
3-8 Battery and battery status indicator
No. Designation Description 1 Battery Supplies power to the device. 2 Fault indicator (red) Lights up if the battery is defective. 3 Status LEDs (green) Show the battery status. 4 Status button Activated by pressing the status LEDs.
3 Description
Status indicator on the battery
WM 68201 12/2017
Status indicator on the device display
Meaning
Battery status > 90%
Battery status approx. 60 %-90 %
Battery status approx. 40 %-60 %
Battery status approx. 10%-40%
MEDUCORE Standard
2
EN 39
3 Description
Status indicator on the battery
Status indicator on the device display
Meaning
Battery status < 10% On the display:
• The last remaining segment in the battery status symbol is red.
• The message Battery weak appears in the display.
• The device outputs in AED mode: Battery weak.
Battery is deeply discharged. Charge battery in the device for 24 hours. After 24 hours:
• Green LED is lit: Battery fully charged and ready for use
• Red LED or no LED is lit: Battery defective. Replace battery.
Battery is empty Battery empty appears on the display and the device outputs in AED mode: Battery empty. The device can still be used for approx. 15 minutes.
Battery is defective. Replace battery.
• Battery is defective.
or
• No battery.
or
• Battery not at suitable temperature.
40 EN MEDUCORE Standard
Green arrow: Battery is charging
WM 68201 12/2017
2

3.6 Components

14325
6
7
8
9
10
12
11
3 Description
3-9 Components
No. Designation Description
1
SoftTip® pulse oximetry sensor, size M, reusable
Measures oxygen saturation.
2 Pulse oximetry sensor connecting cable Connects the pulse oximetry sensor to the device.
3 SpO
connector
2
4 ECG electrodes for adults and children Derive the electrocardiograms.
5 ECG connector
Connects the pulse oximetry sensor to the device via the pulse oximetry connecting cable.
Connects the ECG electrodes to the device via the ECG cable.
6 ECG cable Conducts the electrocardiograms to the device.
Conduct the electrocardiograms to the device and the defibrillation energy to the patient.
Connects the defibrillation electrodes to the trunk cable.
MEDUCORE Standard
2
EN 41
7 Defibrillation electrodes for adults
8 Pad connector
WM 68201 12/2017
3 Description
No. Designation Description
9 Trunk cable
Connects the defibrillation electrodes and the function test resistor to the device.
10 SD card Records session data. 11 NIBP connecting tube Connects the NIBP cuff to the device.
12
NIBP cuff, adult, for 23-33 cm upper arm circumference, reusable
For measuring patient’s blood pressure.
42 EN MEDUCORE Standard
WM 68201 12/2017
2

3.7 Accessories

1 2
12
3
4
5
9
6
8
7
10
11
3 Description
WM 68201 12/2017
3-10 Accessories
MEDUCORE Standard
2
EN 43
3 Description
No. Designation Description 1 Charging station for battery WM 45045 Allows external battery charging.
2 Protective transport bag
Protects the device against damage and facilitates transportation.
Conducts the electrocardiograms to the device.
3 ECG cable
Available in various designs (see "16.3 Accessories",
page 191).
4 DEFIview PC software Facilitates the read-out and analysis of session data.
5
6 Disposable pulse oximetry sensor
7 NIBP cuff
8 SoftTip
Adapter tube for connection of NIBP disposable cuffs for neonates
®
pulse oximetry sensor, reusable
Connects the NIBP cuffs for neonates (disposable).
Measures oxygen saturation. Available in various sizes
(see "16.3 Accessories", page 191)
Measures blood pressure. Available in various versions and sizes (see "16.3 Accessories", page 191)
Measures oxygen saturation. Available in various sizes
(see "16.3 Accessories", page 191)
9 Ear-clip pulse oximetry sensor, reusable Measures oxygen saturation. 10 Wrap pulse oximetry sensor, reusable Measures oxygen saturation.
11 Power supply unit and charger
Supplies the device or the charging station with power.
12 Defibrillation electrodes for children Allow the defibrillation of children.
44 EN MEDUCORE Standard
WM 68201 12/2017
2

3.8 Transport options

3-11 Transport options (examples)
In order to transport the device, carry accessories, provide a charging voltage and attach to a wall mounting, you can mount the device on one of the following portable systems:
• LIFE-BASE 3 NG
• LIFE BASE 1 NG XL
3 Description
WM 68201 12/2017
• LIFE BASE 1 NG XS
Protective transport bag (cannot be attached to the wall mounting)

3.9 Options

You can tailor the range of functions on the device to your needs with the optional functions. You need a release code to enable the optional functions. This device-specific code can be used to enable the options (see "5.14 Enable options", page 101).
Available options:
• Manual defibrillation
MEDUCORE Standard
2
EN 45
3 Description
54136
9
7
8
2
10
SN

3.10 Markings and symbols

3.10.1 Markings on the device
3-12 Markings on the product
No. Symbol Description Device information label
1
= 200 J Maximum energy generated
E
max
46 EN MEDUCORE Standard
Serial number
Input (12 V-15 V, 30 W)
Direct voltage
Do not dispose of device in household waste
Type of protection against electric shock: Protection class II device
2
WM 68201 12/2017
No. Symbol Description
Date of manufacture
Degree of protection against
IP55
1
• Ingress of solid objects
• Ingress of dust
• Ingress of water with harmful effect
Follow Instructions for Use
CE mark (confirms that the product complies with the applicable European directives)
Other labels and symbols
Safety check label (only in the Federal Republic of Germany): Indicates when
2
the next safety check in accordance with §11 of the Medizinprodukte­Betreiberverordnung [German regulations governing owners/operators of medical devices] is required.
Metrological check label (only in the Federal Republic of Germany): Indicates
3
M
when the next metrological check in accordance with §14 of the Medizinprodukte-Betreiberverordnung [German regulations governing owners/operators of medical devices] is required.
4 Follow Instructions for Use
3 Description
5 Follow Instructions for Use
6 Input voltage (12 V-15 V)
Pad Connection for trunk cable
7
SpO
8
Defibrillation-proof Type BF applied part
Connection for pulse oximetry sensor
2
Defibrillation-proof Type BF applied part
9 Defibrillation-proof Type BF applied part
ECG Connection for ECG cable
10
WM 68201 12/2017
Defibrillation-proof Type CF applied part
MEDUCORE Standard
2
EN 47
3 Description
3
1
76 54
2
3.10.2 Markings on the battery
3-13 Markings on the battery
No. Symbol Description
1 Battery fault, if fault indicator light is red
2 Battery status
3 7
4 Manufacturer
Follow Instructions for Use
5 Do not dispose of in household waste.
6
48 EN MEDUCORE Standard
China RoHS label (confirms that the product does not emit toxic substances for the number of years indicated)
2
WM 68201 12/2017
3.10.3 Markings on the pulse oximetry sensors
Symbol Description
Follow Instructions for Use
Do not dispose of in household waste.
Manufacturer
3.10.4 Markings on the ECG cable
Symbol Description
Follow Instructions for Use
Do not dispose of in household waste.
3 Description
WM 68201 12/2017
3.10.5 Markings on the defibrillation electrodes
Follow the Instructions for Use for the defibrillation electrodes.
3.10.6 Markings on the NIBP cuffs
Follow the Instructions for Use for the NIBP cuffs.
MEDUCORE Standard
2
EN 49
3 Description
15
SN
3.10.7 Markings on the packaging
Symbol Description Device packaging
REF
4
SN
Battery packaging
REF
Article number
Permissible storage temperature: -40 °C to +70 °C
Permissible storage humidity: 15 % to 95 % relative humidity
Keep dry
Fragile
Follow Instructions for Use
Serial number
CE mark (confirms that the product complies with the applicable European directives)
Manufacturer
Article number
Permissible storage temperature: -30 °C to +70 °C
Keep dry
Permissible storage humidity: Max. 95 % relative humidity
Serial number
Manufacturer
50 EN MEDUCORE Standard
WM 68201 12/2017
2
Symbol Description
SN
sensor packaging
SpO
2
Do not dispose of in household waste.
Non-sterile
Latex-free
Permissible storage humidity: Max. 95 % relative humidity
Permissible storage temperature: -40 °C to +70 °C
IPX7 Degree of protection against temporary immersion in water
IPX2
Degree of protection against water dripping at an angle, 15° relative to the normal operating position
Serial number
3 Description
WM 68201 12/2017
REF
Article number
CE mark (confirms that the product complies with the applicable European directives)
Date of manufacture
Manufacturer
Disposable item, do not reuse
Follow Instructions for Use
Expiration date
Production batch number
MEDUCORE Standard
2
EN 51
3 Description
SN
Symbol Description ECG cable packaging
4
REF
NIBP cuff packaging
Follow the Instructions for Use for the NIBP cuffs.
Defibrillation electrode packaging
Follow the Instructions for Use for the defibrillation electrodes.
ECG electrode packaging
Follow the Instructions for Use for the ECG electrodes.
Permissible storage temperature: -40 °C to +70 °C
Permissible storage humidity: Max. 95 % relative humidity
Do not dispose of in household waste
Article number
Serial number
Follow Instructions for Use
Manufacturer
Date of manufacture
52 EN MEDUCORE Standard
WM 68201 12/2017
2
4 Preparation

4.1 Mounting the device

The device is mounted on a portable system as standard and is ready for use. Follow the Instructions for Use for the portable systems.

4.2 Connecting to a power supply

Risk of injury due to missing battery!
During line operation, defibrillation is not possible without the battery. Line operation without the battery impairs the operational readiness of the device. Only operate the device with the battery inserted.
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, the water jet protection for the SD card slot is closed and the lines for the ECG, SpO 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, or accessories in
liquids.
Only operate the device with the battery inserted. Always close the water jet protection of the SD card slot. Always leave the lines for ECG, SpO
connecting tube including NIBP cuff connected.

4 Preparation

, trunk cable and NIBP
2
, trunk cable and NIBP
2
WM 68201 12/2017
1. Check battery status (see "3.5 Battery and battery status
indicator", page 39).
2. If necessary: Charge battery (see "4.3.2 Charging the battery
in the device", page 55).
MEDUCORE Standard
2
EN 53
4 Preparation
3. Slide the fully charged battery into the battery compartment until it clicks into place.
4. If necessary: If operating on the portable system, mount the portable system on a wall mounting with charging interface
or
Connect the device with its power supply unit and charger to the line power.
or
Connect the device to a vehicle electrical system with a 12 V cable.
Result The power supply is connected.
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).

4.3 Using the rechargeable battery

4.3.1 General instructions
• Always operate the device with the rechargeable battery WM 45045.
54 EN MEDUCORE Standard
WM 68201 12/2017
2
4 Preparation
• Note the methods of storing the battery and the charging
intervals for prolonged storage (see "13.3 Storing the battery",
page 173).
• The expected life of the battery is 2 years. Recommendation:
Replace the battery after 2 years. If battery life has substantially dropped before then, replace the battery earlier.
• If you receive a replacement battery, you need to fully charge
it before the first use.
4.3.2 Charging the battery in the device
Requirement • The portable system is mounted on a wall mounting with
charging interface.
or
• The device is connected to the line power via the power supply
unit and charger or via the 12 V network.
1. Insert battery into the battery compartment.
When doing so, please note:
• Charging starts automatically if the following conditions are met:
WM 68201 12/2017
Specification Description
External voltage At least 11 V Battery status <95% charged Battery temperature Between 0 °C and 45 °C
• If the device is switched on, the green arrow appears in the battery status symbol on the display (example: ) and the battery status indicator on the device flashes green.
• If the device is switched off, only the battery status indicator flashes green.
• The device remains fully ready for use.
If the battery is deeply discharged and you charge it in the device, the battery status indicator will light up red for a short period of time. It goes out again when the battery status progresses.
MEDUCORE Standard
2
EN 55
4 Preparation
2. When the battery status indicator lights up green and/or the symbol appears on the display: Disconnect the device from the charging interface or from the power supply unit and charger.
Result The battery is fully charged.
4.3.3 Charging the battery with the charging station
You can also charge the battery with the charging station WM 45190. Follow the Instructions for Use for the charging station.
4.3.4 Changing the battery
Requirement The replacement battery is fully charged.
1. If the device is not connected to the line power: Switch off the device (see "5.2 Switching the device off", page 77).
2. Take battery out of the battery compartment.
3. Slide the replacement battery into the battery compartment until it audibly clicks into place.
4. If necessary: Switch on the device (see "5.1 Switching the
device on", page 76).
The symbol appears on the display.
Result The battery is changed.
56 EN MEDUCORE Standard
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2
4 Preparation

4.4 Connecting the trunk cable and defibrillation electrodes

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, the water jet protection for the SD card slot is closed and the lines for the ECG, SpO 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, or accessories in
liquids.
Only operate the device with the battery inserted. Always close the water jet protection of the SD card slot. Always leave the lines for ECG, SpO
connecting tube including NIBP cuff connected.
The following section describes how to attach the defibrillation electrodes to the device and to the patient's torso. The specifications in the Instructions for Use provided by the manufacturer of the defibrillation electrodes and the information on the packaging of the defibrillation electrodes are decisive for the use of the defibrillation electrodes. Observe these Instructions for Use and packaging information.
, trunk cable and NIBP
2
, trunk cable and NIBP
2
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1. Plug the connector of the trunk cable into the pad connection
on the device.
MEDUCORE Standard
2
EN 57
4 Preparation
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 and patient burns. Select the correct size of defibrillation electrodes pursuant to
the resuscitation guidelines and not based on the weight specifications given on the packaging.
2. Select suitable adult (Adult) or child (Pediatric) defibrillation electrodes.
3. Attach the pad connector of the defibrillation electrodes to the trunk cable. When doing so, please note: The pad connector must be fully inserted.
4. Bare the patient's torso.
Risk of injury from incorrect positioning of the defibrillation electrodes!
Incorrect positioning of the defibrillation electrodes leads to a sub­optimal defibrillation result.
Select the electrode position according to the illustration.Maintain distance from ECG electrodes.
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2
4 Preparation
12
5. Select the required electrode position on the patient's torso:
• Position 1: Sternum-apex
• Position 2: Anterior-posterior (can also be used for adults)
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 hirsute patients.Rub the patient's skin dry.Firmly press on the defibrillation electrodes.Wipe down oily skin with an alcohol pad.
6. If necessary: Remove hair from the torso.
7. If necessary: Rub damp spots on the torso dry.
8. If necessary: Wipe down oily skin with an alcohol pad.
9. Tear open the defibrillation electrode packaging and take out
the defibrillation electrodes.
10. Remove the protective backing from the defibrillation
electrodes.
11. Stick on defibrillation electrodes and press firmly in place.
12. If necessary: Stroke out any trapped air from under the
defibrillation electrodes.
Result The trunk cable and defibrillation electrodes are connected.
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MEDUCORE Standard
2
EN 59
4 Preparation

4.5 Connecting the pulse oximetry sensor

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, the water jet protection for the SD card slot is closed and the lines for the ECG, SpO 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, or accessories in
liquids.
Only operate the device with the battery inserted. Always close the water jet protection of the SD card slot. Always leave the lines for ECG, SpO
connecting tube including NIBP cuff connected.
, trunk cable and NIBP
2
, trunk cable and NIBP
2
1. Connect the SpO2 connector of the pulse oximetry sensor connecting cable to the SpO
port on the device.
2
2. Select the appropriate pulse oximetry sensor for the patient group:
Pulse oximetry sensor Patient group Application site
SoftTip® sensor size S Ø 7.5 mm-12.5 mm finger diameter
®
sensor size M Ø 10 mm -19 mm finger diameter
®
sensor size L Ø 12.5 mm-25.5 mm finger diameter
SoftTip
Finger/large toeSoftTip
Wrap sensor > 10 kg body weight Finger/hand Ear-clip sensor > 30 kg body weight Ear
60 EN MEDUCORE Standard
2
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4 Preparation
Pulse oximetry sensor Patient group Application site
Disposable sensor for adults (Adult)
Disposable sensor for children (Pediatric)
Disposable sensor for infants (Infant)
> 30 kg body weight
10 kg-50 kg body weight
10 kg-20 kg body weight
Finger/large toe
3. Connect the selected pulse oximetry sensor to the pulse
oximetry sensor connecting cable.
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4. Press the lock until it clicks into place.
5. Switch on the device (see "5.1 Switching the device on", page
76).
6. Select the patient group in the start menu.
MEDUCORE Standard
2
EN 61
4 Preparation
7. Attach the pulse oximetry sensor:
Pulse oximetry sensor
SoftTip® sensor
Special feature: The finger mark must point upwards
Wrap sensor
Special feature: The sensor's transmitter and receiver must be aligned to face each other on one axis.
Attachment
Ear-clip sensor
62 EN MEDUCORE Standard
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2
4 Preparation
Pulse oximetry sensor
Disposable sensor
Special feature: The sensor's transmitter and receiver must be aligned to face each other on one axis.
Attachment
When doing so, please note:
• The site must have a good blood supply.
• When attaching to the finger: If possible, use the ring or middle finger of the non-dominant hand.
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8. Check whether the oxygen saturation values displayed on the device are plausible.
Result A pulse oximetry sensor is connected.
MEDUCORE Standard
2
EN 63
4 Preparation

4.6 Connecting the ECG cable and ECG electrodes

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, the water jet protection for the SD card slot is closed and the lines for the ECG, SpO 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, or accessories in
liquids.
Only operate the device with the battery inserted. Always close the water jet protection of the SD card slot. Always leave the lines for ECG, SpO
connecting tube including NIBP cuff connected.
, trunk cable and NIBP
2
, trunk cable and NIBP
2
1. Connect the ECG connector of the ECG cable to the ECG
connection for the ECG cable on the device.
2. Bare the patient's torso.
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4 Preparation
Risk of injury due to air/moisture between ECG electrodes and the patient's skin!
Air (e.g. in the case of hirsute patients) or moisture between the ECG electrodes and the patient's skin impair the quality of the ECG signal and falsify the measurement results. This can injure the patient.
Remove hair in hirsute patients.Rub the patient's skin dry.Wipe down oily skin with an alcohol pad.
3. If necessary: Remove hair from the torso.
4. If necessary: Rub damp spots on the torso dry.
5. If necessary: Wipe down oily skin with an alcohol pad.
6. Remove the protective backing from the ECG electrodes.
Risk of injury from incorrect positioning of the ECG electrodes!
Incorrectly positioned ECG electrodes impair the quality of the ECG signal and falsify measurements.
Select the electrode position according to the illustration.Position the ECG electrodes so that defibrillation is possible.Maintain distance from the defibrillation electrodes.Do not position ECG electrodes on tendons or muscle groups.
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MEDUCORE Standard
2
EN 65
4 Preparation
R/RA
N/RL
F/LL
L/LA
7. Stick and firmly press on the ECG electrodes as follows:
Code 1 (Europe) Code 2 (America) Electrode
marking
Color coding
Electrode marking
Color coding Application site
R Red RA White
L Yellow LA Black
F Green LL Red
N Black RL Green
Right arm; shortened: under right collarbone
Left arm; shortened: under left collarbone
Left leg; shortened: Left groin crease, centrally to leg axis
Right leg; shortened: Right groin crease, centrally to leg axis
4-1 Regular position for ECG electrodes
66 EN MEDUCORE Standard
2
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4 Preparation
R/RA
N/RL
L/LA
F/LL
4-2 Shortened position for ECG electrodes
8. If the ECG electrodes are used at the same time as the defibrillation electrodes: Do not allow ECG electrodes and defibrillation electrodes to overlap.
9. If necessary: Stroke out any trapped air from under the ECG electrodes.
10. Clip the ECG cable to the individual ECG electrodes.
11. Switch on the device (see "5.1 Switching the device on", page
76).
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12. Select the patient group in the start menu.
13. Check whether the ECG curves for ECG measurement displayed on the device are plausible.
Result The ECG cable and the ECG electrodes are connected.
MEDUCORE Standard
2
EN 67
4 Preparation

4.7 Attaching the NIBP cuff

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, the water jet protection for the SD card slot is closed and the lines for the ECG, SpO 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, or accessories in
liquids.
Only operate the device with the battery inserted. Always close the water jet protection of the SD card slot. Always leave the lines for ECG, SpO
connecting tube including NIBP cuff connected.
The following section describes how to attach the NIBP cuff. The Instructions for Use provided by the NIBP cuff manufacturer are binding for attachment. Follow these Instructions for Use.
2
, trunk cable and NIBP
, trunk cable and NIBP
2
1. Connect the NIBP connecting tube to the NIBP connection on the device.
68 EN MEDUCORE Standard
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2
4 Preparation
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.
2. Select the NIBP cuff which is suitable for the patient's limb as
per the following table.
Designation Color Limb circumference Thigh
Thigh Brown 38-50 cm
Upper arm
Large Adult plus Dark red 40-55 cm Adult plus Dark blue 28-40 cm Adult Dark blue 23-33 cm Small Adult Turquoise 17-25 cm Child Green 12-19 cm Infant Orange 8-13 cm
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MEDUCORE Standard
2
EN 69
4 Preparation
Select a
larger one
Right sizeSelect a
smaller one
RANGE
When doing so, please note:
• The index printed on the NIBP cuff must be within the
printed range.
• If the index marking does not extend into the printed
range: Select a larger NIBP cuff.
• If the index marking extends beyond the printed range:
Select a smaller NIBP cuff.
70 EN MEDUCORE Standard
• In the case of disposable cuffs for neonates, use adapter
tube (WM 45467).
3. Switch on the device (see "5.1 Switching the device on", page
76).
Risk of injury due to incorrectly selected patient group!
If the incorrect patient group is selected, the contact pressure of the NIPB cuff may be too high and injure the patient.
Adapt the patient group to the patient.If necessary: Change the patient group in the application
menu.
4. Select the patient group in the start menu.
2
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4 Preparation
5. Connect the NIBP connecting tube to the tube of the NIBP cuff.
6. Turn the two tubes towards each other until they lock into
place.
Risk of injury due to incorrectly attached NIBP cuff!
An incorrectly attached NIBP cuff can result in excessive contact pressure. This can stop the blood supply and injure the patient.
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 to which an SpO
sensor
2
is already attached.
Do not attach the NIBP cuff to a limb with open wounds or
burns.
With long-term NIBP monitoring, check the position of the
NIBP cuff regularly and, if necessary, reposition.
Do not attach the NIBP cuff to a limb with poor circulation.Do not bend or crush the NIBP cuff tube or the NIBP connecting
tube.
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MEDUCORE Standard
2
EN 71
4 Preparation
7. Attach the empty NIBP cuff to fit closely around the patient's limb.
When doing so, please note:
• The skin below the NIBP cuff must be undamaged.
• The NIBP cuff must fit tightly around the limb.
• The artery (“Artery”) marking of the NIBP cuff must be
positioned above the artery and point toward the hand/ foot.
• If the NIBP cuff is attached to the arm: The NIBP cuff must
be positioned level with the heart.
8. Once the NIBP measurement is complete: Remove the NIBP cuff.
Result An NIBP cuff which is suitable for the patient is attached.
72 EN MEDUCORE Standard
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2

4.8 Using the SD card

Loss of data due to incorrect SD card!
SD cards not purchased from WEINMANN Emergency may have reduced functionality or result in the loss of data.
Only use SD cards from WEINMANN Emergency.Do not use the SD card for third-party files.
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, the water jet protection for the SD card slot is closed and the lines for the ECG, SpO 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, or accessories in
liquids.
Only operate the device with the battery inserted. Always close the water jet protection of the SD card slot. Always leave the lines for ECG, SpO
connecting tube including NIBP cuff connected.
4.8.1 Inserting an SD card
4 Preparation
, trunk cable and NIBP
2
, trunk cable and NIBP
2
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The device has only a limited internal memory. To record session data over an extended period of time, you must insert an SD card:
1. Open the water jet protection of the SD card slot.
MEDUCORE Standard
2
EN 73
4 Preparation
2. Push the SD card into the SD card slot until it clicks into place. When doing so, please note: The beveled corner of the SD card must be at the front on the right during insertion.
3. Close the water jet protection to protect the device from the ingress of dust and water.
Result The SD card is inserted in the device and ready for use.
After the device is switched on, the symbol appears on the display.
4.8.2 Removing the SD card
Requirement An SD card is in the SD card slot.
1. Open the water jet protection of the SD card slot.
Incorrect use may result in loss of data!
If you remove the SD card while the symbol is displayed or during an ongoing session, data may be lost or the SD card damaged. Only remove the SD card if the device is switched off or the
following symbols or are displayed.
2. Briefly press in the SD card. The SD card is ejected slightly.
3. Remove SD card.
4. Close the water jet protection to protect the device from the ingress of dust and water.
74 EN MEDUCORE Standard
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2
Result The SD card is removed.
The symbol appears on the device display.
4 Preparation
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MEDUCORE Standard
2
EN 75

5 Operation

5 Operation

5.1 Switching the device on

Requirement • The ECG cable and the defibrillation electrodes are not
• A fully charged battery is inserted in the device.
1. Briefly press the On/Off button .
connected to the patient.
An automatic self-test starts, which runs through the following sequence:
• Alarm light flashes and test tone sounds
• The start screen appears
• Shock standby indicator is illuminated
The self-test is successful when all of the steps have been completed. When doing so, please note:
• If the device was switched off for ≥ 30 s: The start menu
appears. The device starts with the presets in the operator menu.
• If the device was switched off for < 30 s and, if whilst
switched on previously, patient measurements were taken or an event was saved manually: The device skips the start menu and starts in the preset start mode and with the preset start view. The settings in the user menu from the last session are retained and the device assigns the session data to the last session.
• If the ECG cable and the defibrillation electrodes were
already connected to the patient at the start of the self-test: The device skips the test of the ECG module and the defibrillation module.
2. If one or more conditions are not met: Do not operate the device.
3. Perform a function check (see "10.2 Performing a function
check", page 148).
76 EN MEDUCORE Standard
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2
Action
Press the function button
5 Operation
Result The device is switched on.

5.2 Switching the device off

1. Press and hold the On/Off button for at least 2 seconds.
Result The device is completely switched off.

5.3 Navigating in the device

Result
In a menu
The function is shown in the display, directly above the function button (e.g. AED or Back).
Within a menu item
In the start menu
In a mode
Turn the navigation knob counterclockwise
Turn the navigation knob clockwise
Press the navigation knob
Press the menu button
Press the view button
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Navigate upwards Decrease value Navigate upwards -
Navigate downwards
Select the menu item
Close the menu Close the menu
---
Increase value
Confirm the set value
Navigate downwards
Select the menu item
Activate the operator menu
MEDUCORE Standard
-
Activate the application menu
Activate the user menu
Switch view:
• Parameter view
•Curve view
2
EN 77
5 Operation
Action
Result
In a menu
Within a menu item
In the start menu
In a mode
Press event button
Press the NIBP button
Requirement The device is switched on (see "5.1 Switching the device on", page
---
---
Manually saves an event in the data set.
• Activate the NIBP
• Start NIBP

5.4 Selecting the patient group

When you select a patient group, the presets which the operator specified for this patient group are loaded. If the operator has not specified presets, the factory settings are loaded.
76).
function mode (press for < 2 s)
measurement (press for > 2 s)
1. When the start menu is active: Select the patient group with the navigation knob.
or
78 EN MEDUCORE Standard
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2
5 Operation
If the timer has expired: The device automatically selects the Adult patient group.
2. During ongoing operation: Open the application menu with
the navigation knob and change the patient group. When doing so, please note: The Infant patient group is not available in AED mode.
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Result The selected patient group is shown in the top right-hand
corner, next to the mode display.
MEDUCORE Standard
2
EN 79
5 Operation

5.5 Performing defibrillation

5.5.1 Semi-automatic defibrillation in AED mode
The defibrillation sequence in the AED mode described here corresponds to the device settings as delivered. The operator menu enables you to adapt the device to users’ qualification level and to provide optimal support to the latter during resuscitation measures whilst taking the regional features into account.
Requirement • The trunk cable and defibrillation electrodes are connected (see
"4.4 Connecting the trunk cable and defibrillation electrodes", page 57).
• The device is switched on (see "5.1 Switching the device on",
page 76).
• The patient group is selected (see "5.4 Selecting the patient
group", page 78).
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 before using the AED mode or the manual
mode.
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.
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 which also guides the user through cardiopulmonary resuscitation by means of voice prompts (e.g. MEDUMAT Easy CPR), 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.
80 EN MEDUCORE Standard
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2
5 Operation
1. Select AED mode with the AED function button.
When doing so, please note:
• Depending on the patient group selected, the AED settings from the operator menu which apply to this group are taken as the basis.
• Upon connection of the defibrillation electrodes for children, the shock energy is limited to 100 J. If a higher shock energy was preset in the device, the device reduces the shock energy to 100 J.
• The “Infant” patient group is not available since the AED analysis algorithm is not suitable for children under the age of 1 year.
• No alarms are displayed or emitted in AED mode.
Risk of injury due to incorrectly selected patient group!
With an incorrectly selected patient group in AED mode, the shock energy, the number of shocks in series, the energy curve and/or the metronome frequency, the ventilation pause and the compression/ventilation ratio may not be suitable for the patient and could result in patient injury.
Adapt the patient group to the patient.If necessary: Change the patient group in the application
menu.
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2. If necessary: Open the application menu with the navigation knob and change the patient group. When doing so, please note: In AED mode, only the adult and child patient groups are available in the application menu.
3. If necessary: Open the application menu with the navigation knob and change the device volume.
4. Follow the voice prompts and AED instructions.
MEDUCORE Standard
2
EN 81
5 Operation
If you operate the device via the line power and the inserted battery is defective or if the battery does not have sufficient capacity to charge the capacitor for shock energy in AED mode, the device guides you through cardiopulmonary resuscitation without creating a shock standby. If you subsequently insert an undamaged and sufficiently charged battery, the device starts the cardiac rhythm analysis immediately and prepares for a shock standby.
Result The device performs a cardiac rhythm analysis. The cardiac rhythm
analysis has one of two results:
• Shock required (see " Shock required", page 82)
or
• Shock not required (see " Shock not required", page 84)
Shock required
The device performs a cardiac rhythm analysis, charges for shock delivery and outputs the message:
Voice prompt AED instruction
Stand clear of the patient Stand clear of the patient Cardiac rhythm is being analyzed Analysis
If, based on the cardiac rhythm analysis, the device determines that a shock is required, the device outputs the message:
Voice prompt AED instruction
Shock required Shock required Press shock button Press shock button
The shock button flashes and an audio alarm sounds.
82 EN MEDUCORE Standard
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2
5 Operation
Risk of injury from electric shock!
The electric shock administered to the patient may result in injury to the patient, user or bystanders.
Stand clear of the patient.Keep patient away from liquids (e.g. blood, gel or saline
solution).
Do not touch parts in contact with the patient
(e.g. bed frames or stretchers).
Keep your distance from liquids in contact with the patient.Clearly warn bystanders to stand clear of the patient or parts in
contact with the patient and to keep their distance from liquids in contact with the patient.
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. Always leave defibrillation electrodes connected to the device
and the patient during shock delivery.
1. Deliver a shock with the shock button . When doing so, please note: If the shock button is not pressed, the capacitor for the shock energy discharges automatically after 15 seconds.
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Result The patient receives an electric shock. The shock energy
corresponds to the settings in the operator menu. Upon delivery, the device settings are as follows:
Patient group Setting
Child
for adults
First shock 75 J, subsequent shocks 75 J
First shock 150 J, subsequent shocks 200 J
The device guides you through cardiopulmonary resuscitation by means of voice prompts, AED instructions and the metronome
(see " Performing cardiopulmonary resuscitation", page 84). It
warns you again to stand clear of the patient after the preset time has elapsed (120 seconds when delivered), in order to perform another cardiac rhythm analysis.
MEDUCORE Standard
2
EN 83
5 Operation
Shock not required
The device performs a cardiac rhythm analysis, charges for shock delivery and outputs the message:
Voice prompt AED instruction
Stand clear of the patient Stand clear of the patient Cardiac rhythm is being analyzed Analysis
If, based on the cardiac rhythm analysis, the device determines that a shock is not required, the device outputs the message:
Voice prompt AED instruction
Shock not recommended Shock not recommended
1. Perform cardiopulmonary resuscitation (see " Performing
cardiopulmonary resuscitation", page 84).
Result The patient does not have a defibrillatable cardiac rhythm. The
device guides you through cardiopulmonary resuscitation by means of voice prompts, AED instructions and the metronome. It warns you again to stand clear of the patient after the preset time has elapsed (120 seconds when delivered), in order to perform another cardiac rhythm analysis.
Performing cardiopulmonary resuscitation
This section describes cardiopulmonary resuscitation in the AED mode. Upon delivery, the device performs cardiopulmonary resuscitation with the following parameters; these, however, can be adapted by the operator:
Setting
Duration of CPR phase 120 s 120 s Ventilation pause 5 s 5 s Compression/ventilation
ratio Start in intubation mode? No No CPR voice prompts No No Metronome frequency 100/min 100/min Start analysis automatically Yes Yes
84 EN MEDUCORE Standard
Patient group for adults Child
30:2 15:2
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2
5 Operation
After cardiac rhythm analysis and shock delivery (if necessary), the device instructs you to carry out cardiopulmonary resuscitation. A metronome provides a guide for chest compressions.
Voice prompt (optional) AED instruction
Carry out cardiopulmonary resuscitation
Cardiopulmonary resuscitation
1. Perform chest compressions:
• 30 chest compressions for the adult patient group
• 15 chest compressions for the child patient group
• Continuous chest compression with intubated patients
When doing so, please note: The metronome sets the ideal frequency.
After 30/15 metronome beats, there is a pause to allow for ventilation:
Voice prompt (optional) AED instruction
Ventilate twice Ventilate twice
2. Ventilate the patient twice.
The device outputs the message:
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Voice prompt (optional) AED instruction
Carry out cardiopulmonary resuscitation
Cardiopulmonary resuscitation
3. Repeat the cardiopulmonary resuscitation sequence.
4. If the patient is intubated: Press the Intub. function button.
The metronome sets a continuous frequency.
5. If the patients shows vital signs (breathing, response): Take
basic patient care steps.
6. After each cardiopulmonary resuscitation cycle: Check that the
defibrillation electrodes are positioned correctly.
Result Cardiopulmonary resuscitation has been performed.
MEDUCORE Standard
2
EN 85
5 Operation
5.5.2 Manual defibrillation (only with Manual defibrillation option)
This function is only available if it has been enabled and activated by the operator: Operator menu | System settings | Enable options | Manual mode (see "8.8 System settings", page 137).
If you are the operator of the device and have access to the operator menu, you can disable the manual mode: Operator menu | System settings | Disable functions | Manual mode (see "8.8
System settings", page 137).
Requirement • The trunk cable and defibrillation electrodes are connected (see
"4.4 Connecting the trunk cable and defibrillation electrodes", page 57).
• The device is switched on (see "5.1 Switching the device on",
page 76).
• The patient group is selected (see "5.4 Selecting the patient
group", page 78).
Risk of injury due to lack of knowledge and failure to follow guidelines in the manual mode!
The use of the manual mode by users without medical qualifications and training in defibrillation and/or failure to follow guidelines can result in injury to the patient, user or bystanders. Only use the manual mode if the user has a medical
qualification and is familiar with the operation of the device.
Follow the defibrillation guidelines.Observe national and regional provisions on defibrillation.Observe organizational guidelines on defibrillation.
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 before using the AED mode or the manual
mode.
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5 Operation
Risk of injury due to incorrectly selected patient group!
If the wrong patient group is selected, the shock energy may be insufficient or too high for the selected patient group and can injure the patient.
Adapt the patient group to the patient.If necessary: Change the patient group in the application
menu.
1. If necessary: Open the application menu with the navigation knob and change the patient group.
2. Select manual mode with the Manual function button. When doing so, please note:
• It is not possible to switch to the parameter view in manual
mode. If you activate the manual mode from the parameter view, there is an automatic switchover to curve view since, for manual shock delivery, the ECG evaluation on the display is required.
• Audio alarm output is deactivated in manual mode. To
activate the audio alarm output, press the alarm button briefly.
3. Evaluate the ECG lead.
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4. If necessary: Select another ECG lead by pressing the Lead function button.
5. If shock is required: Select shock energy by pressing the Energy function button. When doing so, please note: Upon connection of the defibrillation electrodes for children (Pediatric), the defibrillation energy is automatically restricted to 100 J. It is not possible to set a higher energy in manual mode.
6. Press the Charging function button. The charge progress bar appears. A rising charge tone sounds until the device is ready to deliver the shock. When the device is charged, a sequence of tones sounds which signalizes shock standby and the shock button flashes.
7. Check ECG derivations to ascertain whether a shock is still required.
MEDUCORE Standard
2
EN 87
5 Operation
Risk of injury from electric shock!
The electric shock administered to the patient may result in injury to the patient, user or bystanders.
Stand clear of the patient.Keep patient away from liquids (e.g. blood, gel or saline
solution).
Do not touch parts in contact with the patient (e.g. bed frames
or stretchers).
Keep your distance from liquids in contact with the patient.Clearly warn bystanders to stand clear of the patient or parts in
contact with the patient and to keep their distance from liquids in contact with the patient.
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. Always leave defibrillation electrodes connected to the device
and the patient during shock delivery.
8. Deliver a shock with the shock button . When doing so, please note: If the shock button is not pressed, the capacitor for the shock energy discharges automatically after 30 seconds.
9. If necessary: Cancel shock charging by pressing the Cancel function button or by switching to another mode.
Result The patient receives an electric shock.
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5 Operation

5.6 Performing pulse oximetry monitoring

Requirement • The device is switched on (see "5.1 Switching the device on",
page 76).
• A patient group is selected (see "5.4 Selecting the patient
group", page 78).
• A pulse oximetry sensor is connected (see "4.5 Connecting the
pulse oximetry sensor", page 60).
1. If necessary: Select another patient group (see "5.4 Selecting
the patient group", page 78).
2. If necessary: Select the monitor mode by pressing the Monitor
function button.
3. If necessary: Switch between parameter view and curve view
with the view button .
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4. In the parameter view: Read off the measured values for
arterial oxygen saturation (SpO
or
MEDUCORE Standard
) and pulse rate (Pulse).
2
2
EN 89
5 Operation
In the curve view: Evaluate the SpO the measured values for arterial oxygen saturation (SpO
curve (Pleth) and read off
2
) and
2
pulse rate (Pulse).
5. If necessary: Make the following SpO menu (see "7.3.3 SpO
settings", page 114):
2
settings in the user
2
• Adapt the feed speed of the plethysmogram
• Give the pulse tone output priority over the heart rate tone
output so that the tone pitch is output depending on oxygen saturation, even when the ECG cable or pad electrodes are connected to the patient.
6. If necessary: Set alarm limits in the user menu (see "7.3.1
Alarm settings", page 111).
or
Set automatic alarm limits in the application menu (see "6
Application menu", page 106).
7. If necessary: Deactivate the pulse tone with the heart rate tone/ pulse tone function button.
8. If there are artifacts in the SpO not sufficient (bar in the SpO
curve or if the signal quality is
2
parameter field): Reposition the
2
pulse oximetry sensor on the patient’s limb.
Result Pulse oximetry monitoring is performed.

5.7 Performing ECG monitoring

Requirement • The device is switched on (see "5.1 Switching the device on",
page 76).
• A patient group is selected (see "5.4 Selecting the patient
group", page 78).
• An ECG cable and the ECG electrodes are connected (see "4.6
Connecting the ECG cable and ECG electrodes", page 64).
1. If necessary: Select another patient group (see "5.4 Selecting
the patient group", page 78).
2. If necessary: Select the monitor mode by pressing the Monitor function button.
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5 Operation
3. If necessary: Open the application menu with the navigation
knob and change the device volume.
4. If necessary: Switch between parameter view and curve view
with the view button .
5. Evaluate the ECG leads and heart rate.
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6. If necessary: Select another ECG lead by pressing the Lead
function button.
7. If necessary: Make the following ECG settings in the user menu
(see "7.3.2 ECG settings", page 113):
• Adapt amplitude scaling in order to adapt the displayed height of the ECG curve to the ECG measuring signal.
• Activate autoscaling in order to have the height of the ECG curve automatically displayed adapted to the ECG measuring signal.
• Adapt the feed speed of the ECG curve.
• Activate the filter to filter disturbances caused by the line supply network out of the ECG display.
If necessary: Set alarm limits in the user menu (see "7.3.1
Alarm settings", page 111).
or
MEDUCORE Standard
2
EN 91
5 Operation
Set automatic alarm limits in the application menu (see "6
Application menu", page 106).
8. If necessary: Switch off the heart rate tone/pulse tone with the function button . The symbol appears.
9. If necessary: Open the application menu with the navigation knob and change the device volume.
Result ECG monitoring is performed.

5.8 Performing non-invasive blood pressure measurement (NIBP)

NIBP measurement technology has been optimized for measuring blood pressure with a normal sinus rhythm. Cardiac arrhythmias can impair the ability of the non-invasive blood pressure measurement module to record correct measured values.
Furthermore, arteriosclerosis, reduced circulation, diabetes, old age, pregnancy, preeclampsia, kidney disease, trembling, shivers and the use of a cardiac pacemaker can impair the ability of the non-invasive blood pressure measurement module to record correct measured values.
5.8.1 NIBP measurement
With an individual NIBP measurement, the device inflates the NIBP cuff to the set pressure (initial NIBP cuff pressure). The user can adapt the initial NIBP cuff pressure (Initial function button). To determine the patient’s systolic and diastolic blood pressure, the air is slowly released from the NIBP cuff whilst measuring the pressure of the pulse wave. The values for the diastolic and systolic blood pressure are determined from this and shown in the display. At the end of the NIBP measurement, the device releases the remaining air from the NIBP cuff.
The NIBP measurement can be influenced by various factors:
• Application site of the NIBP cuff
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5 Operation
• Patient position (ideal position: Sitting comfortably, legs not crossed, feet flat on the floor, back and arm supported, middle of the NIBP cuff level with the right heart atrium)
• Exertion (recommendation: Patient should rest for 5 minutes before the measurement, keep still during the measurement and not speak)
• Physiological condition.
Performing the NIBP measurement
Requirement • An NIBP cuff is connected to the NIBP connecting tube (see
"4.7 Attaching the NIBP cuff", page 68).
• The device is switched on (see "5.1 Switching the device on",
page 76).
• The patient group is set (see "5.4 Selecting the patient group",
page 78).
Risk of injury due to incorrectly selected patient group
The device only provides correct measured values if the appropriate patient group is selected. An incorrect patient group can lead to incorrect measurements and patient injuries. Select the suitable patient group for the patient (see "5.4
Selecting the patient group", page 78).
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Risk of injury due to incorrectly selected NIBP cuff
The device only provides correct measured values if the appropriate NIBP cuff is selected. An unsuitable NIBP cuff can lead to incorrect measurements and patient injuries. Select the suitable NIBP cuff for the patient (see "4.7 Attaching
the NIBP cuff", page 68).
1. Press the NIBP button for < 2 s. The device switches to NIBP function mode.
2. If necessary: Select another patient group (see "5.4 Selecting
the patient group", page 78).
The NIBP module is configured in the device accordingly with the selected patient group.
MEDUCORE Standard
2
EN 93
5 Operation
3. If necessary: Adapt the initial NIBP cuff pressure to the patient with the Initial function button and navigation knob. When doing so, please note: Following successful NIBP measurement, the initial NIBP cuff pressure adapts to the patient (approx. 30 mmHg above the systolic measured value of the previous NIBP measurement).
4. Press the Start function button.
or
Press the NIBP button for > 2 s. An NIBP measurement starts. At the end of the measurement, the device shows the systolic and diastolic arterial pressure.
5. Evaluate the NIBP measurement.
6. If implausible measured values are shown:
• Check whether the NIBP cuff is correctly selected and
attached.
• If necessary: Repeat the NIBP measurement.
7. If necessary: Cancel the NIBP measurement with the Stop function button. The device releases the pressure from the NIBP cuff.
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5 Operation
8. If necessary: Set alarm limits in the user menu (see "7.3.1
Alarm settings", page 111).
or
Set automatic alarm limits in the application menu (see "6
Application menu", page 106).
9. If necessary: Press the Back function button.
or
Press the NIBP button for < 2 s. The device ends the NIBP function mode and switches to the set mode.
Result Non-invasive blood pressure measurement has been performed.
5.8.2 Interval measurement
During an interval measurement (Interval function button), the device performs several successive NIBP measurements. The interval duration indicates the time between two successive NIBP measurements.
Performing the interval measurement
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Requirement • An NIBP cuff is connected to the NIBP connecting tube (see
"4.7 Attaching the NIBP cuff", page 68).
• The device is switched on (see "5.1 Switching the device on",
page 76).
• The patient group is set (see "5.4 Selecting the patient group",
page 78).
1. Press the NIBP button for < 2 s.
The device switches to NIBP function mode.
2. If necessary: Select another patient group (see "5.4 Selecting
the patient group", page 78).
The NIBP module is configured in the device accordingly with the selected patient group.
3. Press the Interval function button.
4. Set the interval duration using the navigation knob.
MEDUCORE Standard
2
EN 95
5 Operation
5. Press the Start function button.
or
Press the NIBP button for < 2 s. An NIBP measurement starts. At the end of the measurement, the device shows the systolic and diastolic arterial pressure, the timer expires and the next measurement starts automatically.
6. Evaluate the NIBP measurement.
7. If necessary: Cancel the NIBP measurement with the Stop function button. The device releases the pressure from the NIBP cuff.
8. If necessary: Set alarm limits in the user menu (see "7.3.1
Alarm settings", page 111).
or
Set automatic alarm limits in the application menu (see "6
Application menu", page 106).
9. If necessary: Press the Back function button.
or
Press the NIBP button for < 2 s. The device ends the NIBP function mode and switches to the set mode.
Result The interval measurement has been performed.
5.8.3 Venous stasis
With venous stasis (iv function button), the device inflates the NIBP cuff and maintains this pressure for the time preset in the operator menu. The venous blood return flow is impeded and the user can puncture one of the patient’s veins. The venous stasis function is only available to the Adult patient group.
If you are the operator of the device and have access to the operator menu, you can disable the Venous stasis function: Operator menu | System settings | Disable functions | Venous stasis
(see "8.8 System settings", page 137).
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5 Operation
Performing venous stasis
Requirement • An NIBP cuff is connected to the NIBP connecting tube (see
"4.7 Attaching the NIBP cuff", page 68).
• The device is switched on (see "5.1 Switching the device on",
page 76).
•The Adult patient group is set.
•A mode is set.
1. Press the NIBP button for < 2 s.
The device switches to NIBP function mode.
2. Press the iv function button.
The NIBP cuff is inflated to the pressure set in the operator menu. The timer displaying the duration of venous stasis expires. During the venous stasis time, the pressure of the NIBP cuff is maintained.
Risk of injury from deflating the pressure in the NIBP cuff too soon.
On expiry of the timer, the venous stasis ends automatically. If the intravenous access is not created during this time, this can injure the patient.
Create the access before the timer expires. If the access cannot be created before the timer expires: Abort
and provide medical treatment to the puncture site.
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3. Create the intravenous access.
4. Once the access has been created: Release the pressure from
the NIBP cuff with the Stop function button.
Result A venous stasis is created.

5.9 Using the audio alarm output

5.9.1 Canceling the audio alarm output
Requirement An alarm is active and is audible.
1. Briefly (< 2 s) press the alarm button .
MEDUCORE Standard
2
EN 97
5 Operation
Result The audio alarm output is canceled for this alarm. The symbol
appears on the display and no audio signal is output for this alarm.
5.9.2 Pausing/muting the audio alarm output
Requirement An alarm is active and is audible.
1. Press and hold the alarm button (> 2 s.).
Result The audio alarm output pauses for the time set in the operator
menu (Operator menu | Alarm settings | Pause audio). The symbol
appears on the display. If you set the time in the operator menu to (infinite), the audio alarm output is permanently paused (audio alarm output is muted). The symbol appears on the display.
If set, a reminder signal will remind you at certain intervals that the audio alarm output is paused or muted. You can set the reminder signal in the operator menu (Operator menu | Alarm settings | Reminder signal).
5.9.3 Canceling muting or pausing of audio alarm output
Requirement An alarm is active and is muted or paused.
1. Briefly (< 2 s) press the alarm button .
or
Switch modes.
Result Muting or pausing of audio alarm output is canceled.

5.10 Saving the event manually in the session data set

Measured values and the user actions performed on the device are saved in the internal memory and on the SD card.
With the event button , events which cannot be recorded by the device automatically (e.g. intubation, medication administration, etc.) can be saved in the data set in order to subsequently assign them chronologically during evaluation.
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5 Operation
Requirement • The device is switched on (see "5.1 Switching the device on",
page 76).
• The patient group is set (see "5.4 Selecting the patient group",
page 78).
1. Press event button .
Result The device saves an event with the designation Manual event in
the session data set and an acknowledgment tone is heard.

5.11 Reprocessing the device after use

1. Remove disposable articles from the patient and dispose of them:
• Defibrillation electrodes
• ECG electrodes
• Disposable pulse oximetry sensor
• Disposable NIBP cuff for neonates
2. Remove the short-term NIBP cuffs from the patient and check the duration of use.
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3. If necessary: Include new short-term NIBP cuffs with the device.
4. Include new disposable articles and, if necessary, a short-term NIBP cuff with the device.
5. Hygienically reprocess the device, components and accessories
(see "9 Hygienic reprocessing", page 144).
6. If necessary: Place components and accessories on the portable system or in the protective transport bag.
7. If necessary: Store the device, components and accessories (see
"13 Storage", page 172).
Result The device is reprocessed following use.
MEDUCORE Standard
2
EN 99
5 Operation

5.12 Saving session data/status log

The device always saves the session data and status log to its internal memory. The status log is required in order to be able to analyze the data should servicing be necessary.
If an SD card is inserted in the SD card slot, the device automatically saves the data to the SD card in addition. The symbol appears on the display. In the first minute after a new session is started, the device only saves the session data temporarily to the device memory, but not yet to the SD card. If you switch off the device during this time, the session data is lost. After the first minute, the device permanently saves the data to the internal device memory and to the SD card (provided that the SD card was inserted in the SD card slot before the start of the session). If the SD card is full, the symbol appears.
If you switch off the device and then switch it on again after < 30 s, the device continues saving the data.
If you switch off the device and then switch it on again after > 30 s, the device creates a new session data set.
Saving session data/status log to SD card
Requirement An SD card is in the SD card slot.
1. Switch on the device (see "5.1 Switching the device on", page
76).
The start menu appears.
2. Press the menu button to call up the operator menu.
3. Enable the operator menu with the access code.
4. Select System settings | SD card.
5. Select the menu item Export internal memory to SD card.
or
Select the menu item Export status log to SD card. The message Start export? appears.
6. Press the function button OK to start copying. The session data/status log are saved to the SD card. During the copying process, the symbol appears
100 EN MEDUCORE Standard
2
WM 68201 12/2017
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