Corpuls 3 инструкция на русском

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Система мониторирования и дефибрилляции модели Corpuls-3 поставляется вместе с принадлежностями. В комплектацию поставки входит трансторакальный кардиостимулятор. Прибор может функционировать в автоматическом и ручном режиме; электрокардиограмма на 12 отведений; также кардиостимулятор оснащен принтером; зарядным устройством. Доступны пульсоксиметрия и плетизмография (SpO2), замеры неинвазивного АД (NIBP), функция капнографии (PetCO2).

Система модели Corpuls-3 — это новейшая модульная система, предназначенная для дефибрилляции (кардиоверсии), внешней кардиостимуляции и наблюдения за витальными функциями больного. Система модели Corpuls-3 оснащена принтером. Соответствует всем нормативам служб экстренной медпомощи на этапе лечения до госпитализации, а также при нахождении на стационаре. В случае надобности прибор может быть поделен на 3 автономных модуля, в числе которых следующие: экран витальных функций, модуль контроля состояния больного, дефибриллятор с кардиостимулятором. Модули можно использовать в автономном режиме или комбинированно с другими модулями. Это дает возможность врачу в случае возникновения непредвиденной ситуации наладить конфигурацию аппарата. Все модули системы мониторирования и дефибрилляции Corpuls-3 оснащены автономным источником электропитания. Они могут связываться с другими модулями прибора с помощью современной беспроводной технологии. Впервые стало достижимым долговременное беспрерывное беспроводное наблюдение за больным, также и в процессе проведения КТ.

Комплектация

• Монитор с принтером
• Модуль пациента с 12 –канальным ЭКГ и интерфейсом для карты
• Защитное покрытие для дисплея
• Модуль дефибриллятора/кардиостимулятора, шт.
• Электроды CorPatch easy для дефибрилляции/кардиостимуляции с кабелем
• Многоразовые электроды для дефибрилляции/кардиостимуляции 2 шт. с кабелем.
• Наплечный ремень для модуля Дефибриллятора/кардиостимулятора
• Литиево-ионовая батарея — 3 шт.
• 4-жильный кабель мониторинга ЭКГ
• 6-жильный кабель для снятия «диагностического» ЭКГ
• Зажимы для предотвращения скручивания жил кабеля — 8 шт.
• Карта памяти CompactFlash ТМ 2 Гб
• Сумка для принадлежностей PAX, черная для модуля пациента.
• Инструкция по использованию пользователя Corpuls-3
• Зарядное устройство с кабелем
• Удлинитель 1,8 м с изогнутым электрозащитным разъемом
• Программное обеспечение corView2
• Бумага для принтера – в упаковке10 рулонов
• Комплект одноразовых электродов для ЭКГ для взрослых-50 шт.
• Встроенный блок SpO2
• Промежуточный кабель для пальцевого датчика SpO2
• Многоразовый пальчиковый датчик MASIMO SpO2 для взрослых и детей от 30 кг. скабелем
• Встроенный блок измерения неинвазивного артериального давления
• Манжета для измерения НИАД для взрослых
• Шланг для манжеты НИАД 2,5 м
• Встроенный блок СО2
• Датчик СО2 capONE
• Одноразовый адаптер для подсоединения к эндотрахеальной трубки СО2 (уп. 30 шт)
• Промежуточный кабель для СО2 capONE

Технические характеристики

С этим товаром покупают

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corpuls

User Manual

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Contents User Manual corpuls

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ii ENG — Version 2.1 – P/N 04130.2

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User Manual corpuls

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Contents

This user manual has been compiled to provide users with information
necessary for safe and trouble-free operation, use on patients and maintenance

3

of corpuls

. All persons dealing with use, maintenance and troubleshooting

must read and implement this user manual.
In addition to this user manual, the currently applicable ordinances and the

generally accepted engineering principles as well as regulations for
occupational health and safety and accident prevention must be complied with.

The corpuls

«Medical Device Directive 93/42/EC of the Commission». The corpuls

3

complies with the basic standards as specified in Annex I of the

3

is a
medical product class IIb. In the UMDNS (Universal Medical Device
Nomenclature System) the corpuls

3

has the code 17-882.

GS Elektromedizinische Geräte
G. Stemple GmbH
Hauswiesenstrasse 26
86916 Kaufering
Germany

All rights reserved, particularly rights of reproduction and distributi on, in additi on to translation.
Technical modifications, errors or printing mistakes reserved.
The rights to the trademarks and registered trademarks remain with the originators and holders of

the respective trademarks.
No part of the user manual may be reproduced,

electronic systems in any form whatsoever without the written agreement of GS Elektromedizinische
Geräte G. Stemple GmbH.

ENG — Version 2.1 – P/N 04130.2 iii

saved, processed, copied or circulated by means of

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Service address

In case of enquiries, please contact:

3

Information on the authorised service and sales partners can also be found on
the following website:

www.corpuls.com

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User Manual corpuls

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Contents

Versions of the corpuls3 user manual

Issue Date User manual version Software version

1 06/2007 ENG V1.1 – 04130.2 1.1.0
2 08/2007 ENG V1.2 – 04130.2 1.2.0
3 11/2007 ENG V1.3 – 04130.2 1.3.0
4 07/2008 ENG V1.4 – 04130.2 1.4.1
5 07/2009 ENG V1.5 – 04130.2 1.5.0
6 12/2009 ENG V1.6 – 04130.2 1.6.0
7 11/2010 ENG V1.7 – 04130.2 1.7.0
8 07/2011 ENG V1.8 – 04130.2 1.8.0
9 10/2011 ENG V1.9 – 04130.2 1.9.0
10 07/2012 ENG V2.0 – 04130.2 2.0.0
11 06/2013 ENG V2.1 – 04130.2 2.1.0

Versions of the supplements
to the user manual corpuls

Version Date Description Version

A 04/2010 Supplement of

the alarm
messages

A 06/2010 New Defibrillator

Keyboard

A 03/2011 Interval

Measurement
NIBP

A 07/2011 NVG mode EN V1.8 – 04130.2 1.8.0

user manual

EN V1.4 — 04130.2
EN V1.5 — 04130.2
EN V1.6 — 04130.2

EN V1.7 — 04130.2 1.7.0

EN V1.7 — 04130.2 1.7.2

Version
Software

1.4

1.5

1.6

ENG — Version 2.1 – P/N 04130.2 v

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Contents User Manual corpuls

Contents

Safety ……………………………………………………………………………………… 1

1

1.1 General ………………………………………………………………………………. 1

1.2 Operating Staff …………………………………………………………………….. 1

1.2.1 Restrictions of Therapeutic Functions ………………………………… 1

1.2.2 Maintenance …………………………………………………………………… 2

1.3 Information and Warning Labels on the Device ………………………… 2

1.4 Warning Notices and Symbols ……………………………………………….. 3

1.5 Special Types of Risk …………………………………………………………… 3

2 Intended Use …………………………………………………………………………… 4

3 Introduction ……………………………………………………………………………. 6

3.1 Components ………………………………………………………………………… 6

3.2 Device Design ……………………………………………………………………… 8

3.2.1 Pairing (Connection Authorisation) …………………………………… 10

3.2.2 Monitoring Unit ………………………………………………………………. 12

3.2.3 Patient Box and Accessory Bag ………………………………………. 14

3.2.4 Defibrillator/Pacer ………………………………………………………….. 17

3.2.5 Defibrillator/Pacer SLIM ………………………………………………….. 18

3.2.6 Brackets ……………………………………………………………………….. 19

3.3 Description of the Monitoring, Diagnostic and Therapeutic

Functions …………………………………………………………………………… 20

3.3.1 Monitoring and Diagnostic F unctio ns ………………………………… 20

3.3.2 Therapeutic Functions ……………………………………………………. 21

3.4 Alarm management …………………………………………………………….. 23

3.4.1 Alarm Signals at the Monitoring unit …………………………………. 24

3.4.2 Alarm Signals at the Patient box ………………………………………. 26

3.5 Energy Management …………………………………………………………… 27

3.5.1 Battery Operation …………………………………………………………… 27

3.5.2 Mains Operation …………………………………………………………….. 29

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4 General Operating Instructions ……………………………………………… 31

4.1 Operating and Display Elements ………………………………………….. 31

4.1.1 Operating Elements and LEDs on the Monitoring Unit ………… 31

4.1.2 Basic Structure of the Display Pages on the

Monitoring Unit ………………………………………………………………. 35

4.1.3 Patient Box Display ………………………………………………………… 39

4.1.4 Control Keys and LEDs on the Patient Box ……………………….. 40

4.1.5 Control Key and LEDs on the Defibrillator/Pacer ……………….. 41

4.1.6 Control Key and LEDs on the Defibrillator /Pac er SLI M ……….. 42

4.2 Switching On and Off ………………………………………………………….. 43

4.2.1 Switching On …………………………………………………………………. 43

4.2.2 Switching Off …………………………………………………………………. 44

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Contents

4.3 Menu Control ……………………………………………………………………… 46

4.3.1 Softkey Context Menu…………………………………………………….. 46

4.3.2 Parameter Context Menu and Curve Context Menu …………… 47

4.3.3 Main Menu ……………………………………………………………………. 49

4.3.4 Configuration Dialogue …………………………………………………… 50

4.4 Disconnecting and Connecting Modules ……………………………….. 51

4.4.1 Disconnecting the Monitoring Unit from the

Defibrillator/Pacer ………………………………………………………….. 51

4.4.2 Disconnecting the Patient Box from the Monitoring

Unit ………………………………………………………………………………. 52

4.4.3 Connecting the Patient Box to the Monitoring Unit ……………… 53

4.4.4 Connecting the Monitoring Unit to the

Defibrillator/Pacer ………………………………………………………….. 54

4.4.5 Removing the Patient Box from the Compact Device …………. 55

4.5 Accessory Bag …………………………………………………………………… 56

4.5.1 Fitting the Accessory Bag ……………………………………………….. 56

4.5.2 Packing the Accessory Bag …………………………………………….. 57

4.6 Inserting the Device into the Brackets …………………………………… 60

4.6.1 Defibrillator/Compact Device Bracket ……………………………….. 60

4.6.2 Monitoring Unit Bracket…………………………………………………… 61

4.6.3 Patient Box Charging Bracket ………………………………………….. 62

5 Operation – Therapy ……………………………………………………………… 63

5.1 Therapy Electrodes for Defibrillation and Pacing …………………….. 63

5.1.1 Types of Therapy Electrodes …………………………………………… 63

5.1.2 Connecting the Electrode Cable ………………………………………. 65

5.1.3 Removing the Shock Paddles from their Holders and

Re-inserting them …………………………………………………………… 66

5.2 Preparing the Patient for Defibrillation, Cardioversion and

Pacer Therapy……………………………………………………………………. 67

5.3 Defibrillation in AED Mode …………………………………………………… 68

5.3.1 Information on the AED Mo de …………………………………………. 68

5.3.2 Defibrillation in AED mode with corPatch Electrodes ……….. 70

5.3.3 Defibrillation in AED Mode with Shock Paddles …………………. 71

5.4 Manual Defibrillation and Cardioversion ………………………………… 74

5.4.1 Information on Manual Defibrillation and

Cardioversion ………………………………………………………………… 74

5.4.2 Manual Defibrillation with corPatch Electrodes ……………….. 76

5.4.3 Manual Defibrillation and C ardio vers i on with Sh ock

Paddles ………………………………………………………………………… 77

5.4.4 Manual Defibrillation and C ardio vers i on with Sh ock

Spoons …………………………………………………………………………. 79

5.4.5 Manual Defibrillation and C ardio vers i on of Neona tes

and Children ………………………………………………………………….. 80

5.5 External Pacer……………………………………………………………………. 81

5.5.1 Information on the External Pacer ……………………………………. 81

5.5.2 Preparing the pacer function ……………………………………………. 83

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5.5.3 Starting the Pacer Function …………………………………………….. 85

5.6 Metronome ………………………………………………………………………… 89

5.6.1 Information on the Metronome …………………………………………. 89

5.6.2 Starting the Metronome ………………………………………………….. 90

5.7 CPR Feedback …………………………………………………………………… 91

5.7.1 Information on CPR Feedback ………………………………………… 91

5.7.2 Preparing CPR Feedback ……………………………………………….. 93

5.7.3 Working with CPR Feedback …………………………………………… 94

6 Operation – Monitoring and Diagnosis …………………………………… 95

6.1 Information on Monitoring and Diagnosis ………………………………. 95

6.2 ECG Monitoring………………………………………………………………….. 95

6.2.1 Information on ECG Monitoring ……………………………………….. 95

6.2.2 ECG Lead Colour Coding ……………………………………………….. 96

6.2.3 Preparing ECG Monitoring ………………………………………………. 97

6.2.4 Performing ECG Monitoring …………………………………………….. 98

6.2.5 Adapting the Representation of the ECG Curve ……………….. 100

6.2.6 Heart Rate Monitoring …………………………………………………… 102

6.3 Recording, Measuring, Printing and Interpreting a

Diagnostic ECG………………………………………………………………… 102

6.3.1 Information on Diagnostic ECG ……………………………………… 102

6.3.2 Preparing the Patient for a D-ECG …………………………………. 103

6.3.3 Recording and Measuring a Diagnostic ECG …………………… 106

6.3.4 Representative Cycle ……………………………………………………. 111

6.4 Longterm ECG …………………………………………………………………. 113

6.4.1 Information on Longterm ECG ……………………………………….. 113

6.4.2 Preparing Longterm ECG ……………………………………………… 114

6.4.3 Performing Longterm ECG ……………………………………………. 114

6.5 Oximetry Monitoring (Option) ……………………………………………… 115

6.5.1 Information on Oximetry Monitoring ………………………………… 115

6.5.2 Preparing Oximetry Monitoring ………………………………………. 117

6.5.3 Performing Oximetry Measurement ………………………………… 118

6.5.4 Adjusting the Representation of the Oximetry

Parameters …………………………………………………………………. 120

6.5.5 Monitoring Pulse Rate and Perfusion Index …………………….. 120

6.6 CO2 Monitoring (option) …………………………………………………….. 121

6.6.1 Information on CO2 Monitoring ………………………………………. 121

6.6.2 Preparing CO2 Monitoring ……………………………………………… 122

6.6.3 Performing CO2 Measurement……………………………………….. 124

6.6.4 Adjusting the Representation of the CO2 Values ………………. 125

6.6.5 Monitoring Respiratory Rate ………………………………………….. 125

6.7 Non-invasive Blood Pressure Monitoring (option) …………………. 126

6.7.1 Information on NIBP Monitoring ……………………………………… 126

6.7.2 Preparing Blood Pressure Monitoring ……………………………… 129

6.7.3 Performing Individual Blood Pressure Measurement ………… 129

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Contents

6.7.4 Performing Blood Pressure Interval Monitoring ………………… 131

6.8 Invasive Blood Pressure Monitoring (Option) ……………………….. 131

6.8.1 Information on IBP Monitoring ……………………………………….. 131

6.8.2 Preparing Invasive Blood Pressure Monitoring ………………… 132

6.8.3 Performing Invasive Blood Pressure Monitoring ………………. 134

6.9 Temperature Monitoring (Option) ………………………………………… 135

6.9.1 Information on Temperature Monitoring ………………………….. 135

6.9.2 Preparing Temperature Monitoring …………………………………. 135

6.9.3 Performing Temperature Monitoring ……………………………….. 136

7 Configuration ………………………………………………………………………. 137

7.1 Configuring the System ……………………………………………………… 137

7.1.1 General System Settings ………………………………………………. 137

7.1.2 Display Configuration ……………………………………………………. 140

7.1.3 Printer settings …………………………………………………………….. 143

7.1.4 Configuration of the Fax Transmission (Default User) ………. 148

7.2 Configuration of the Monitoring Functions ……………………………. 148

7.2.1 ECG Monitoring …………………………………………………………… 148

7.2.2 Oximetry ……………………………………………………………………… 150

7.2.3 CO2 ……………………………………………………………………………. 151

7.2.4 IBP …………………………………………………………………………….. 152

7.2.5 CPR Feedback …………………………………………………………….. 154

7.3 Alarm Configuration ………………………………………………………….. 155

7.3.1 Configuring Alarm Settings ……………………………………………. 155

7.3.2 Configuring Alarm Settings ……………………………………………. 156

7.3.3 Setting Alarm Limits for Monitoring Functions

Manually ……………………………………………………………………… 156

7.3.4 Setting the Alarm Limits for Monitoring Functions

Automatically ……………………………………………………………….. 158

7.4 Advanced Settings (Persons Responsible for the Device) …….. 159

7.4.1 Authorisation for Persons Responsible for the Device ………. 159

7.4.2 General System Settings (Person responsible for the

device) ……………………………………………………………………….. 160

7.4.3 Configuration of the Defibrillation Function (Persons

Responsible for the Device) …………………………………………… 163

7.4.4 Filter Settings (Persons Responsible for the Device) ………… 165

7.4.5 Alarm Configuration (Persons Responsible for the

Device) ……………………………………………………………………….. 166

7.4.6 Basic Configuration of the Views (Persons

Responsible for the Device) …………………………………………… 168

7.4.7 Configuration of Master Data (Persons Responsible

for the Device) ……………………………………………………………… 169

7.4.8 Configuration of Telemetry (Persons Responsible for

the Device) ………………………………………………………………….. 170

7.4.9 Bluetooth® data interface (Persons Responsible for

the Device) ………………………………………………………………….. 177

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7.4.10 Configuration of ECG Measurement and ECG

Interpretation (Persons Responsible for the Device) …………. 179

7.4.11 Demo Mode (Persons Responsible for the Device) ………….. 181

7.4.12 Data Protection Settings (Persons responsible for the

device) ……………………………………………………………………….. 182

7.4.13 Configuration of the Metronome (Persons

Responsible for the Device) …………………………………………… 183

7.4.14 Configuration of Non-I nv as i ve Blood Pres s ure
Measurement (NIBP) (Persons Responsible for the

Device) ……………………………………………………………………….. 184

8 Data Management ……………………………………………………………….. 186

8.1 Creating a Patient File ………………………………………………………. 186

8.2 Event Key ………………………………………………………………………… 187

8.3 Handling Data ………………………………………………………………….. 187

8.4 Master Data ……………………………………………………………………… 188

8.5 Browser Key …………………………………………………………………….. 189

8.5.1 Protocol ………………………………………………………………………. 189

8.5.2 Mission Browser …………………………………………………………… 192

8.6 Analysis of the Data with corView2 ……………………………………… 193

8.7 Screenshot ………………………………………………………………………. 194

8.8 Telemetry (Option) ……………………………………………………………. 194

8.8.1 Installing the SIM Card………………………………………………….. 196

8.8.2 Starting Fax Transmission …………………………………………….. 196

8.8.3 Starting Live Data transmission with corpuls.web ………… 198

8.9 Bluetooth® data interface …………………………………………………… 199

8.9.1 Establishing and interrupting a Bluetooth® connection ……… 201

8.10 Insurance card reader (option) ……………………………………………. 202

8.10.1 Data Transmission via Bluetooth® ………………………………….. 204

8.11 Insurance card reader (Option) …………………………………………… 204

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9 Maintenance and Tests ………………………………………………………… 206

9.1 General Information ………………………………………………………….. 206

9.2 Function Checks ………………………………………………………………. 207

9.2.1 Function check of the Device …………………………………………. 208

9.2.2 Function check of the Power Supply ………………………………. 213

9.2.3 Checking Accessories and Consumables ……………………….. 213

9.3 Automatic Self Test …………………………………………………………… 215

9.4 Regular Maintenance Work ……………………………………………….. 215

9.4.1 Safety-related Checks…………………………………………………… 215

9.4.2 Metrological Check ………………………………………………………. 216

9.4.3 Repair and Service ………………………………………………………. 216

9.5 Loading the Printer Paper ………………………………………………….. 217

9.6 Changing the Battery ………………………………………………………… 218

9.7 Cleaning, Disinfection and Sterilisat io n ……………………………….. 219

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Contents

9.7.1 Monitoring Unit, Patient Box and Defibrillator/Pacer …………. 219

9.7.2 Shock Paddles …………………………………………………………….. 221

9.7.3 Therapy Master Cable ………………………………………………….. 222

9.7.4 Cables for Monitoring Functions …………………………………….. 222

9.7.5 Oximetry Sensor ………………………………………………………….. 222

9.7.6 CO2 Sensor …………………………………………………………………. 223

9.7.7 NIBP Cuffs ………………………………………………………………….. 223

9.7.8 IBP Transducer Cable…………………………………………………… 223

9.7.9 Temperature Sensor …………………………………………………….. 223

9.7.10 Accessory Bag and Carrying Strap …………………………………. 223

9.8 Approved Accessories, Spare Parts and Consumables …………. 224

10 Procedure in Case of Malfunctions ………………………………………. 233

10.1 Device alarms ………………………………………………………………….. 233

10.2 Troubleshooting and Corrective Actions ………………………………. 250

10.3 Notifications Message Line and Inf ormation in the

Protocol …………………………………………………………………………… 263

Appendix ………………………………………………………………………………………….. 272

A Symbols ………………………………………………………………………….. 272

B Function Checklist …………………………………………………………….. 277

C Factory Settings ……………………………………………………………….. 278

D Technical Specifications ……………………………………………………. 286

E Biphasic Defibrillator …………………………………………………………. 300

F Saf et y Information …………………………………………………………….. 303

G ECG Analysis during Sem i-automatic Defibrillation (AED

mode) ……………………………………………………………………………… 307

H corpuls3 HYPERBARIC (HBO) …………………………………………… 310

I Guidelines and Manufacturer’s Declaration ………………………….. 311

J Warranty ………………………………………………………………………….. 316

K Protection Rights and Patents ……………………………………………. 317

L Disposal of the Device and Acc ess or ies ………………………………. 318

M Note on Data Protection …………………………………………………….. 319

N List of Illustrations …………………………………………………………….. 320

O List of Tables ……………………………………………………………………. 325

Index 328

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Conventions

The following conventions app l y in this user m anual:

3

Key

Key on monitoring unit, patient box and

defibrillator/pacer
[Softkey] Softkey on the monitoring unit
«Menu item» ► «Submenu item» Menu items of the main menu and

parameter and curve context menus
«Alarm message» Messages for physiological and

technical alarms on the monitoring unit

and patient box
VERBAL MESSAGE Spoken operating instructions and

alarm messages in the AED mode

Operating instructions and i nf ormation

information

in the message line of the monitoring

unit

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oxyg

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Safety

1 Safety

1.1 General

The corpuls

• in technically perfect condition;

• used as intended (see chapter 2 Intended Use, p. 4);

• the instructions of this user manual are followed.

Malfunctions must be eliminated immediately (see chapter 10 Pr oce dur e in
Case of Malfunctions, page 233).

For the product variant corpuls
Appendix H corpuls3 HYPERBARIC (HBO).

3

may only be operated if:

3

HYPERBARIC please read and understand

1.2 Operating Staff

The corpuls

hospitals, doctor’s offices and emergency medical services, as well as of
authorities and public safety organisations.

The qualified staff must be

• trained in proper handling, use and operation of the device and of the
approved accessories as well as be

• trained in basic and advanced resuscitatory measures (BLS and ALS).

The initial instruction and training on the device must be performed by the
manufacturer or by authorised personnel.

1.2.1 Restrictions of Therapeutic Functions

Use of the therapeutic functions (defibrillation, cardioversion and pacing) is
restricted to qualified and authorised staff.

The manufacturer recommends that persons who use the therapeutic functions
of the device should take part in refresher courses regularly. The operating
company/operator is responsible for offering such refresher courses.

3

may only be operated by trained medical staff of for example

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Intended Use

1.2.2 Maintenance

Maintenance work may only be performed by persons who are appropriately
trained and authorised by the manufacturer. Failure to observe this will result in
invalidation of claims under the warranty.

1.3 Information and Warning Labels on the Device

User Manual corpuls

l instructions in the user manual

3

the patient or patient’s heart

-proof):

component of this type is approved for

-proof):

NOT approved for operation in a hyperbaric

Fig. 1-1 Sample rating plate

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Warning

Caution

3

Safety

1.4 Warning Notices and Symbols

A number of actions during the operation of the corpuls
patients, users and third parties.

Such actions are indicated by warni ng not ices in this user manual.
The following symbols are used:

«Warning» denotes a dangerous situation.
If the warning is not heeded, extremely severe injuries or substantial material
damage may occur.

«Caution» denotes a possibly dangerous situation.
If not heeded, minor injuries or slight material damage may occur.

These paragraphs contain information which must be read and understood.

3

carry risks for

1.5 Special Types of Risk

The defibrillator emits powerful electrical energy. Severe injuries or death may
result if the defibrillator is not used in accordance with this user manual.

• Familiarise yourself with the device and this user manual.

The defibrillator must not be opened. Internal components may carry high
voltages.

• If a fault is suspected, have the device checked by the authorised sales
and service partner and, if necessary, repaired.

The defibrillator may cause electromagnetic interference, particularly during
charging and on triggering the defibrillation shock.

The functioning of devices operated in the vicinity may be compromised.

• Check the effects of the defibrillator on other devices, preferably before
an emergency occurs.

Electromagnetic fields of other devices may invalidate the ECG readings.
ECG analysis may be impaired. It may be impossible to trigger a defibrillation

shock or pacer pulse.

• Please read and follow the instructions for operation of the device in
chapter 2 Intended Use, p. 4 in addition to the safety warnings during use

It is essential to read and follow the safety information in the appendix F (from
page 272).

.

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2 Intended Use

The corpuls3 is intended

• for measurement and monitoring of vital functions in addition to

• defibrillation, cardioversion or cardiac pacing

of patients in the preclinical and clinical field by qualified medical staff trained in
the use of the device.

The following monitoring functions are available:

• ECG

• diagnostic ECG

Optional:

• oximetry (SpO

2,

• capnometry (CO

• temperature (T)

• non-invasive blood pressure monitoring (NIBP)

• invasive blood pressure monitoring (IBP)

The corpuls

3

is approved for monitoring in operating diagnostic X-ray units
(e. g. computed tomography). Exempt from this is the oximetry option, because
measured values might be falsified. When equipped with the HBO (hyperbaric
oxygen therapy) option, the corpuls
hyperbaric chamber up to 3 barg and an oxygen concentration of < 23%.

Intended use of corpuls

• approved by the manufacturer (see chapter 9.8 Approved Accessories,
Spare Parts and Consumables, p. 224) and

• appropriate for the function and patient.

Use of accessories on corpuls
is not considered to be intended use.

®,

SpCO

)

2

SpHb, SpMet®)

3

is approved for operation in a multiplace

3

includes employment of accessories which are

3

which are not approved by the manufacturer

4

Warning

Defibrillation protection for patients, user and third parties cannot be
guaranteed, if accessories other than those authorised by the manufacturer
are used.

The therapeutic functions of defibrillation, cardioversion and pacer must only be
performed with constant monitoring of the patient.

Performing the therapeutic functions without eye contact with the patient is not
considered to be intended use.

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User Manual corpuls

3

Intended Use

If monitoring functions are performed, the patient’s condition must also be
regularly monitored even when the alarm function is enabled.

The corpuls

3

is not intended for

• operation in the vicinity of readily inflammable substances,

• setup and operation under the influence of strong electromagnetic fields,

which occur in the direct vicinity of radio masts, switched-on nuclear
magnetic resonance tomography units, high voltage installations and
overhead power lines,

• operation in the vicinity of therapeutic radiation units (e.g. tumor
treatment),

• operation in connection with a high frequency surgical device,

• operation in a monoplace hyperbaric chamber (option HBO),

• operation in a multiplace hyperbaric chamber with more than 3 barg

and/or more than 23 % oxygen concentration (option HBO).

The pacer function must not be used near high frequency surgical devices or
microwave therapy devices .

Individual modules must not be used without batteries inserted.

Defibrillation and cardioversion must not be performed without protec t ive
measures (see chapter 5.3.1 Information on the AED Mode , p. 68 and 5.4.1
Information on Manual Defibrillation and Cardioversion, p. 74):

• on a metal surface;

• on a wet surface.

The defibrillator must only be used for defibrillation and cardioversion and must
not be used as a stimulation current device or as a pacer.

The pacer may only be used as a transcutaneous pacer.
The pacer must not be used as an intracardial defibrillator.

3

The corpuls

may not be used simultaneously on two or more patients.

The manufacturer cannot accept any liability for damage occurring as a result of
failure to use corpuls

3

as intended.

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Introduction

3 Introduction

3.1 Components

corpuls

The corpuls
functions for treatment of emergency and intensive-care patients. Especially as
part of the resuscitation of emergency patients, defibrillations, cardioversions or
pacer therapies can also be performed, in addition to monitoring of vital
parameters.

A maximum of six ECG curves can be displayed on the monitor at the same
time. A 12 lead ECG function allows the user a comprehensive ECG diagnosis,
which can be optionally supplemented by ECG analysis software.

Further monitoring functions include oxygen saturation measurement (pulse
oximetry), carbon dioxide measurement (capnometry) and temperature
measurement, in addition to non-invasive and invasive blood pressure
monitoring. The recorded measuring values can be displayed both numerically
and as a curve. Configurable alarms draw the user’s attention to current
changes in the patient’s condition. All measured values or logs can be printed
out on paper.

corpuls

events, alarms and logs. These can be transferred to external systems for
further processing and arch iving .

3

is a portable device with a modular structure which can be used

• as a defibrillator/monitor or

• as a full patient monitor in its own right.

3

provides comprehensive monitoring, diagnostic and therapeutic

3

has extensive documentation functions for internal recording of

User Manual corpuls

3

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User Manual corpuls

3

Introduction

Fig. 3-1 Compact device

1 Accessory bag
2 Shock paddles (2 x)
3 Printer

The corpuls

3

can be tilted vertically up to 30°.

Depending on the mission conditions, the monitor can be adjusted to the
appropriate visual angle.

The system can be divided into the following three modules :

• Monitoring unit

• Patient box

• Defibrillator/Pacer

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Fig. 3-2 Individual modules

1 Monitoring unit
2 Patient box
3 Defibrillator/Pacer

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Introduction

3.2 Device Design

The three modules monitoring unit, patient box and defibrillator/pacer can
operate via an infrared connection or, if separated, via radio connection.

The connection status is shown on the display of the monitoring unit (see Table
4-2, page 36) and the patient box (see Table 4-3, page 39).

Communication between the modules in semi-modular and modular use is
performed by radio up to a distance of 10 m in open terrain.

In the connected mechanically state, the modules communicate via an optical
infrared connection.

If the radio connection is interrupted, the modules have to be connected to each
other mechanically. The corpuls
connection to infrared connection in this case.

The antenna of the radio unit in the patient box is located at the top. In case the
antenna is shadowed, for example by metallic or metallised objects, the
maximal reach of the radio connection may be reduced. This may happen, for
example, when the patient box is placed between the patient’s legs on the
stretcher. If possible, choose a position for the patient box that allows
unimpeded view to the other modules.

The following combinations are possible:

User Manual corpuls

3

switches automatically from radio

3

Device Design Defibrillator-/pacer unit Defibrillator-/pacer unit

SLIM

1. Compact
device:

All three modules
are connected
mechanically

2. Semi-modular
use:

Monitoring unit
and patient box
are connected,
defibrillator/ pacer
is disconnected.

3. Semi-modular
use:

Monitoring unit
and
defibrillator/pacer
are connected,
patient box is
disconnected.

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User Manual corpuls

3

Introduction

4. Modular use:

Monitoring unit,
patient box and
defibrillator/pacer
are disconnected
mechanically

Fig. 3-3 Usage options of the modular corpuls3

The following combinations are possible when used as a stand-alone patient
monitoring system:

1. Compact monitor:

Monitoring unit and patient box are
connected mechanically

2. Modular monitoring mode:

Monitoring unit and patient box are
disconnected mechanically

3. Patient box:

Patient box in stand-alone use for
temporary initial monitoring

Fig. 3-4 Usage options of the modular corpuls3

as a patient monitoring system

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Introduction

3.2.1 Pairing (Connection Authorisation)

The modules of the corpuls
means of two procedures:

• Pairing and

• Ad-hoc connection

The corpuls

3

thus provides the option of substituting individual modules of one

compact device for in di vidu al modules of the same t ype f rom another corpuls

It is not possible to connect a monitoring unit to more than one patient box or
one defibrillator/pacer at the same time.

Pairing is a connection authorisation that enables the communication between
wirelessly connected modules.

An ad-hoc connection allows the use of mechanically connected modules
without having to perform a pairing beforehand.

For both procedures the following prerequisites apply:

1. For a pairing, monitoring unit, patient box and defibrillator/pacer have to be
equipped with radio modules of the same type (hardware version).

2. If this is not the case, if the hardware version of the radio modules is
different (1

st

and 2nd generation), those modules can only form an ad-hoc

connection.

3. For both a pairing and for an ad-hoc connection all modules have to be
equipped with an identical sof tware versio n.

As of July 2011 the corpuls3 comes equipped with a second generation radio
module. This new radio module is not compatible with those of the first
generation.

The corpuls

3

modules with the 2nd generation radio module are labelled with a

number symbol. This symbol is attached at the following places:

• Monitoring unit: at the front side, top left,

• Patient box: on top,

• Defibrillator/pacer: at the rear side, on top.

The number symbol also marks the position of the radio module in the modules.

3

can be connected to form a functional unit by

User Manual corpuls

3

3

.

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User Manual corpuls

3

Introduction

To star a pairing, proceed as follows:

1. Connect the monitoring unit, the patient box and, if present, the
defibrillator/pacer mechanically.

2. There are the following options:

a) The message Perform pairing? appears:

Confirm the message by pressing the softkey [Start].

b) The message Perform pairing? does not appear:

Select in the main menu «System“► «Start Pairing».

3. The message Pairing successful appears on the screen oft he
monitoring unit. The three modules now are paired. The corpuls

3

is ready

for operation via wireless connection.

To start an ad-hoc connection, proceed as follows:

1. Connect the modules mechanically.

2. Do not confirm the message Perform pairing?

The message Ad-hoc connection [Module], e.g. Ad-hoc
connection P-box or Ad-hoc connection Defib appears on the

screen of the monitoring unit. The corpuls

3

is ready for operation.

The connection status is shown by symbols in the status line in the upper right
corner of the monitoring unit (see Table 4-2 Module connection status, page 36
and Appendix A Symbols, page 272) .

If a new pairing is performed between a monitoring unit and a patient box or
with another compact device, the previously saved wireless connection
authorisation to the patient box or to the defibrillator/pacer is automatically
deleted.

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Caution

Caution

Warning

When connecting different patient boxes by ad-hoc connection, there can be
inconsistent entries in the data management.

During an ad-hoc connection a wireless connection to other modules is not
possible.

If two modules connected by an ad-hoc connection are separated, a radio
connection to the original patient box and defibrillator/pacer is automatically
re-established.

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Introduction

3.2.2 Monitoring Unit

User Manual corpuls

3

Fig. 3-5 Monitoring Unit

1 Display
2 Alarm and event function keys
3 Status LED power supply/charging status
4 On/Off key with operating status LED
5 Defibrillation mode function key s
6 Insurance card reader
7 Jog dial and alarm light
8 Function keys for navigation
9 Print key
10 Operating mode keys
11 Printer
12 Softkeys

The monitoring unit is the central user interface of corpuls

3

. The monitoring
unit comprises the display (item 1), the printer (item 11) and the insurance card
reader (item 6, option) , as wel l th e jog dial (item 7) , the f unc tion keys (items 2, 5,
8 and 9), the operating mode keys (item 10) and the softkeys (item 12).

The jog dial is used to navigate in the main menu, the parameter and curve
context menus and in the display areas on the display.

An alarm light is integrated into the jog dial.
The monitor, pacer and operation browser functions can be selected directly by

pressing the function keys.
Softkey assignment varies according to the selected function. Softkey

assignments are described in the chapters dealing with the respective functions.

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User Manual corpuls

3

Fig. 3-6 shows the interfaces on the monitoring unit

Introduction

Fig. 3-6 Monitoring unit, rear view

1 Cover for LAN interface (option)
2 SIM card slot (slot for SIM card tray)
3 Contact element with patient box
4 Infrared interface with patient box
5 Infrared interface with defibrillator/pacer
6 Charging cable magnetic plug socket
7 Contact element with defibrillator/pacer
8 Fold-out feet

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Introduction

3.2.3 Patient Box and Accessory Bag

Fig. 3-7 Patient Box (illustration may differ)

1 Sensor interfaces
2 Multifunction key
3 Multifunction LED operating status/HR/alarm
4 On/Off key
5 Status LED power supply/charging status
6 Display
7 Microphone
8 Acoustic alarm (pulse signal indicator)
9 Infrared interface with monitoring unit
10 Contact element

The patient box monitors and records the monitoring sensor signals. The
sensors of the various monitoring functions are connected to it.

The patient box can be used as a stand-alone unit (without the monitoring unit)
for patient monitoring. The display (item 6) on the patient box shows the
following:

• The monitoring function values

• Physiological and technical alarms.

• Heart rate is visually represented by an LED (item 3).

User Manual corpuls

3

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User Manual corpuls

3

Patient Box Interfaces

Fig. 3-8 Patient Box Interfaces, right hand side, ports for:

1 CO2: sensor for capnometry
2 NIBP: sensor for non-invasive blood pressure monitoring
3 Temp-1: temperature sensor
4 Temp-2: temperature sensor
5 P1 P2: sensor for invasive blood pressure monitoring (channels 1 and 2)
6 P3 P4: sensor for invasive blood pressure monitoring (channels 3 and 4)
7 CPR: CPR feedback sensor

Introduction

ENG — Version 2.1 – P/N 04130.2 15

Fig. 3-9 Patient Box Interfaces, left hand side, ports for:

1 USB interface (devices up to 09/2010)
2 Rainbow®: interface for oximetry sensor
3 CF: slot for CompactFlash® card for data back-up
4 ECG-D: complementary ECG diagnostic cable
5 ECG-M: ECG monitoring cable

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Introduction

Caution

At the moment, connecting USB devices or –cables to the USB slot is not
allowed.

Accessory Bag

An accessory bag is available for the patient box (P/N 04221.1).
The accessory bag is used to store the preconnected cables as well as the

sensors and ECG electrodes, so that they are quickly accessible during use.

User Manual corpuls

3

Fig. 3-10 Patient Box with Accessory Bag

1 Patient box
2 Accessory bag

Chapter 4.5 Accessory Bag, p. 56 contains information on installing and packing
the accessory bag.

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User Manual corpuls

3

3.2.4 Defibrillator/Pacer

Introduction

Fig. 3-11 Defibrillator/Pacer

1 Equipotential bonding pin with insu lat ing cap
2 Shock paddle
3 On/Off key
4 Therapy master cable with plug
5 Cable socket with test contact
6 Stand and storage compartments
7 Contact element with monitoring unit
8 Infrared interface with monitoring unit
9 Compartment for corPatch electrodes

The therapy electrodes have to be connected to the therapy master cable
(item 4). The therapy master cable can be wound around the socket (item 5).
The plug can be lodged in the socket.

Equipotential bonding can be performed during clinical use with the
equipotential bonding pin (item 1). For this, the insulating cap has to be
removed.

The shock paddle marked with the green label APEX must be positioned in the
right-hand shock paddle holder to ensure that the twistproof plug connector on
the therapy master cable is correctly aligned. For guidance, identical labels for
the APEX and STERNUM shock paddle are located on the side of the
defibrillator/pacer. The plug can be lodged in the socket.

The stand (item 6) additionally serves as a storage compartment for electrode
gel and razors, etc.

The angle of the defibrillator/pacer can be tilted vertically (30°) to achieve an
optimal view of the screen during use.

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Introduction

3.2.5 Defibrillator/P acer SLIM

The defibrillator/pacer SLIM differs from the previous defibrillator/pacer unit only
in terms of form and weight.
The basic functions are identical.

User Manual corpuls

3

Fig. 3-12 Defibrillator/Schrittmacher Slim

1 Carrying handle and lock
2 Therapy socket
3 Contact element with monitoring unit
4 Infrared interface with monitoring unit
5 Equipotential bonding pin with insu lat ing cov er
6 On/Off key

The therapy electrodes have to be connected to the therapy socket (item 2).
Equipotential bonding can be performed during clinical use with the
equipotential bonding pin (item 5). For this, the insulating cover has to be
removed.

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