Weinmann MEDUCORE Standard2 User manual

MEDUCORE Standard2
Monitor/Defibrillator
Instructions for Use for Devices from Software Version 1.1

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Table of Contents
Table of Contents
1 Introduction 6
1.1 Intended use ................................................................................. 6
1.2 Function ........................................................................................ 6
1.3 Operator/user qualification ............................................................ 8
1.4 Contraindications for defibrillation ................................................. 8
1.5 Side effects ................................................................................... 9
2 Safety 10
2.1 Safety information ....................................................................... 10
2.2 General instructions .................................................................... 24
2.3 Warnings in this document .......................................................... 25
3 Description 26
3.1 Overview ..................................................................................... 26
3.2 Control panel .............................................................................. 27
3.3 Display ........................................................................................ 29
3.4 Symbols on the display ................................................................ 37
3.5 Battery and battery status indicator ............................................. 39
3.6 Components ............................................................................... 41
3.7 Accessories ................................................................................. 43
3.8 Transport options ........................................................................ 45
3.9 Options ....................................................................................... 45
3.10 Markings and symbols ................................................................. 46
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
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 SpO2settings ............................................................................ 132

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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
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 Alarms and faults 156
11.1 General instructions .................................................................. 156
11.2 Alarm messages ........................................................................ 158
11.3 Faults ........................................................................................ 165
12 Maintenance 170
12.1 General instructions .................................................................. 170
12.2 Intervals .................................................................................... 170
12.3 Sending in device ...................................................................... 171
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 Standard2is a mobile external defibrillator with
monitoring functions. It is used to measure and monitor vital
parameters and for defibrillation of emergency patients.
The following monitoring and diagnostic functions are available:
• 6-lead monitoring ECG
• Pulse oximetry
• Non-invasive blood pressure measurement
The following therapy functions are available:
• Manual defibrillation
• Semi-automatic defibrillation (from age 1)
1.2 Function
The device offers the following monitoring and diagnostic
functions:
• 6-lead monitoring ECG: The electrical activity of the heart is
derived and shown on the display. This allows the user to
interpret cardiac rhythms and the heart rate. The 6-lead
monitoring ECG does this by deriving the standard (Einthoven)
limb leads (I, II, III) and augmented (Goldberger) limb leads
(aVR, aVL, aVF) and displaying them in the curve view.

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1 Introduction
• Pulse oximetry: Pulse oximetry monitoring allows continuous,
non-invasive measurement of the arterial oxygen saturation
with the aid of different pulse oximetry sensors for different
application sites. At the same time, a photo sensor in the pulse
oximetry sensor registers the percentage of oxygenated
hemoglobin in the arterial blood (SpO2) using different light
wavelengths. In addition, the pulse oximetry sensor registers
the pulse rate. The values for SpO2and pulse rate are shown
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.
• 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 Standard2must 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 Introduction
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
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.
2.1.1 Qualification
Warning Risk of injury due to lack of knowledge and failure to follow
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 hirsute patients.
⇒Rub the patient's skindry.
⇒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.
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.