Weinmann MEDUCORE Standard2 User manual

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

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

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

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

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

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

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

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

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

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