Dräger Infinity Acute Care System M540 Bedienungsanleitung

Instructions for Use

Infinity Acute Care System

M540 Patient Monitor

Software VG2

WARNING

To properly use this medical device,

read and comply with these Instruc-

tions for Use.

2Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2

Typographical conventions

Any text shown on the screen and any labeling on

the device are printed in bold and italics, for exam-

ple, Alarms, or Menu.

The "greater than" symbol >indicates the naviga-

tion path in a dialog window, for example, Menu >

Patient setup > Admit date. In this example,

Menu represents the fixed key, Patient setup rep-

resents a horizontal tab, and Admit date a menu

selection.

Screen images

Schematic renderings of screen images are used,

which may differ in appearance or in configuration

from the actual screen images.

1Consecutive numbers indicate steps of action,

with the numbering restarting with "1" for each

new sequence of actions.

zBullet points indicate individual actions or differ-

ent options for action.

– Dashes indicate the listing of data, options, or

objects.

(A) Letters in parentheses refer to elements in the

related illustration.

ALetters in illustrations denote elements referred

to in the text.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 3

Trademarks and patents

– Acute Care SystemTM

– DrägerService®

– Infinity®

– Hemo4®

– Hemo2®

– Innovian®

–MCable

– Medical CockpitTM

–MPod

– MonoLead®

–TruST

are trademarks of Dräger.

–Masimo

– Masimo SET®(Signal Extraction Technology)

– Masimo Rainbow®SET

– PVI®

–SpCO

–SpHb

–SpMet

–SpOC

are registered trademarks of the Masimo corpora-

tion.

– DurasensorTM

– Nellcor®

– OxiMax®

– OxiCliqTM

–OxiBand

–SoftCare

– SatSeconds®

are trademarks of Nellcor Puritan Bennett, LLC.

– ComplianceTM

is a trademark of Cardinal Health, Inc.

– Dismozun®pur

is a trademark of BODE Chemie GmbH.

– Sporox II®

is a trademark of Sultan Healthcare, Inc.

4Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2

Safety information definitions

Abbreviations and symbols

Please refer to "Device symbols" on page 26 and to

"Abbreviations" on page 28 for explanations.

WARNING

A WARNING statement provides important

information about a potentially hazardous

situation which, if not avoided, could result in

death or serious injury.

CAUTION

A CAUTION statement provides important infor-

mation about a potentially hazardous situation

which, if not avoided, may result in minor or mod-

erate injury to the user or patient or in damage to

the medical device or other property.

NOTE

A NOTE provides additional information intended

to avoid inconvenience during operation.

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 5

Contents

For your safety and that of your patients. . . 9

General safety information . . . . . . . . . . . . . . . . 13

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Infinity M540 . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

System overview . . . . . . . . . . . . . . . . . . . . . . 19

Overview of Infinity M540 . . . . . . . . . . . . . . . . . 20

Infinity M500 docking station . . . . . . . . . . . . . . 23

Additional hardware . . . . . . . . . . . . . . . . . . . . . 24

Device symbols . . . . . . . . . . . . . . . . . . . . . . . . 26

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Operating concept . . . . . . . . . . . . . . . . . . . . . 31

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

M540 wireless mode . . . . . . . . . . . . . . . . . . . . 32

Function keys . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Monitoring area. . . . . . . . . . . . . . . . . . . . . . . . . 38

Adjusting the display. . . . . . . . . . . . . . . . . . . . . 41

Battery power . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Power-saving mode . . . . . . . . . . . . . . . . . . . . . 43

Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Standby mode. . . . . . . . . . . . . . . . . . . . . . . . . . 45

Privacy mode . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Docking/undocking the M540 . . . . . . . . . . . . . . 49

Locking/unlocking the M540. . . . . . . . . . . . . . . 50

Connecting the system cables in an IACS

configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Connecting the system cable in an M540

stand-alone configuration . . . . . . . . . . . . . . . . . 51

Mounting the Infinity MCable – Masimo SET

and Masimo Rainbow SET/Nellcor OxiMax

MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Getting started . . . . . . . . . . . . . . . . . . . . . . . . 55

Overview of monitoring a patient . . . . . . . . . . . 56

Turning the M540 on/off . . . . . . . . . . . . . . . . . . 56

Admitting a patient . . . . . . . . . . . . . . . . . . . . . . 57

Discharging a patient . . . . . . . . . . . . . . . . . . . . 58

Patient categories . . . . . . . . . . . . . . . . . . . . . . 58

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Overview of alarms . . . . . . . . . . . . . . . . . . . . . 62

Alarm priorities . . . . . . . . . . . . . . . . . . . . . . . . 62

Alarm processing. . . . . . . . . . . . . . . . . . . . . . . 63

Activating or deactivating alarm validation . . . 64

Visual alarm signals . . . . . . . . . . . . . . . . . . . . 65

Acoustic alarm signals. . . . . . . . . . . . . . . . . . . 67

Testing visual and acoustic alarm signals . . . . 68

Special alarm behavior . . . . . . . . . . . . . . . . . . 68

Pre-silencing alarms . . . . . . . . . . . . . . . . . . . . 70

Pausing acoustic alarm signals . . . . . . . . . . . . 70

Pausing alarm monitoring temporarily . . . . . . . 71

Activating or deactivating alarm monitoring. . . 72

Configuring a patient’s alarm settings . . . . . . . 73

Event recall . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Viewing a snapshot of a single event . . . . . . . 77

Alarm management setup (password-

protected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

The Code function key . . . . . . . . . . . . . . . . . . 78

Alarm groups . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Alarm ranges and defaults . . . . . . . . . . . . . . . 79

ECG, arrhythmia, and ST segment. . . . . . . . 87

Overview of ECG and heart rate monitoring . . 89

ECG precautions . . . . . . . . . . . . . . . . . . . . . . . 90

Connecting the 3-, 5-, 6-lead wire sets for

ECG monitoring. . . . . . . . . . . . . . . . . . . . . . . . 90

Connecting the lead wire set for 12-lead ECG

monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Connecting the lead wires for neonatal ECG

monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Patient preparation for ECG monitoring . . . . . 93

ECG display . . . . . . . . . . . . . . . . . . . . . . . . . . 94

ECG electrode colors . . . . . . . . . . . . . . . . . . . 95

Electrode placement . . . . . . . . . . . . . . . . . . . . 95

12-lead monitoring. . . . . . . . . . . . . . . . . . . . . . 98

Accessing the ECG dialog window . . . . . . . . . 99

ECG parameter setup functions . . . . . . . . . . . 99

Monitoring paced patients . . . . . . . . . . . . . . . . 102

Pacemaker precautions. . . . . . . . . . . . . . . . . . 103

Optimizing pacer processing . . . . . . . . . . . . . . 105

Arrhythmia monitoring overview . . . . . . . . . . . 105

Contents

6Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2

Selecting ARR leads . . . . . . . . . . . . . . . . . . . . 106

ARR modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

ARR display . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Accessing the ARR dialog window . . . . . . . . . . 110

ARR parameter setup functions . . . . . . . . . . . . 110

Monitoring ST overview . . . . . . . . . . . . . . . . . . 111

Standard ST monitoring . . . . . . . . . . . . . . . . . . 111

TruST 12-lead monitoring. . . . . . . . . . . . . . . . . 112

12-Lead ST monitoring. . . . . . . . . . . . . . . . . . . 112

Connecting lead wire sets for ST monitoring . . 113

ST display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

ST complex dialog windows . . . . . . . . . . . . . . . 114

ST measuring points . . . . . . . . . . . . . . . . . . . . 115

ST reference. . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Accessing the ST dialog window . . . . . . . . . . . 116

ST setup functions . . . . . . . . . . . . . . . . . . . . . . 116

Learning/relearning QRS pattern . . . . . . . . . . . 118

Impedance respiration (RRi) . . . . . . . . . . . . . 119

Overview of RRi monitoring . . . . . . . . . . . . . . . 120

RRi precautions . . . . . . . . . . . . . . . . . . . . . . . . 120

Connecting the 3-, 5-, 6-lead wire sets for RRi

monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Connecting the lead wire set for 12-lead RRi

monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Connecting the lead wires for neonatal RRi

monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Patient preparation for respiration monitoring . 123

RRi display . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

RRi measuring modes . . . . . . . . . . . . . . . . . . . 126

Accessing the RRi dialog window . . . . . . . . . . 126

RRi parameter setup functions . . . . . . . . . . . . . 127

SpO2and Pulse CO-Ox monitoring with

Masimo SET MCables . . . . . . . . . . . . . . . . . . 129

Overview of SpO2monitoring . . . . . . . . . . . . . . 130

SpO2and Pulse CO-Ox precautions . . . . . . . . 132

Connecting the Masimo SET MCable . . . . . . . 134

Connecting the Masimo Rainbow SET

MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Patient preparation . . . . . . . . . . . . . . . . . . . . . . 136

SpO2and Pulse CO-Ox display . . . . . . . . . . . . 137

Accessing the SpO2dialog window . . . . . . . . . 139

SpO2parameter setup functions . . . . . . . . . . . 139

Accessing the Pulse CO-Ox dialog window . . . 141

Pulse CO-Ox parameter setup functions . . . . . 141

Password-protected Masimo Rainbow SET

setup functions . . . . . . . . . . . . . . . . . . . . . . . . . 144

SpO2and pulse rate with Nellcor OxiMax

MCable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Overview of SpO2monitoring . . . . . . . . . . . . . 146

SpO2precautions . . . . . . . . . . . . . . . . . . . . . . 147

Connecting the Nellcor OxiMax MCable . . . . . 148

Patient preparation for SpO2monitoring . . . . . 149

SpO2display . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Accessing the SpO2dialog window. . . . . . . . . 151

SpO2parameter setup functions . . . . . . . . . . . 151

Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . 153

Overview of temperature monitoring . . . . . . . . 154

Connecting the temperature sensors . . . . . . . 154

Temperature display . . . . . . . . . . . . . . . . . . . . 157

Accessing the temperature dialog window . . . 158

Temperature parameter setup functions . . . . . 158

Non-invasive blood pressure (NIBP) . . . . . . 159

Overview of NIBP monitoring . . . . . . . . . . . . . 160

NIBP precautions . . . . . . . . . . . . . . . . . . . . . . 161

Connecting the NIBP hose and cuff . . . . . . . . 162

Patient preparation for NIBP monitoring . . . . . 163

NIBP display . . . . . . . . . . . . . . . . . . . . . . . . . . 164

NIBP measurement modes . . . . . . . . . . . . . . . 165

Venous stasis . . . . . . . . . . . . . . . . . . . . . . . . . 167

Accessing the NIBP dialog window . . . . . . . . . 168

NIBP parameter setup functions . . . . . . . . . . . 168

Invasive blood pressure (IBP) . . . . . . . . . . . 169

Overview of IBP monitoring. . . . . . . . . . . . . . . 170

IBP precautions. . . . . . . . . . . . . . . . . . . . . . . . 172

Connecting the Hemo4 and Hemo2 pods . . . . 173

Connecting the MPod – QuadHemo . . . . . . . . 174

Connecting the Dual Hemo MCable . . . . . . . . 175

Patient preparation for IBP monitoring . . . . . . 176

IBP display . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Labeling IBP pressure channels . . . . . . . . . . . 177

Standard pressure labels. . . . . . . . . . . . . . . . . 178

Pressure label conflicts . . . . . . . . . . . . . . . . . . 179

Zeroing an IBP transducer . . . . . . . . . . . . . . . 179

Pulmonary wedge pressure. . . . . . . . . . . . . . . 181

Accessing the IBP dialog window . . . . . . . . . . 181

IBP parameter setup functions . . . . . . . . . . . . 181

Cardiac Output (C.O.) . . . . . . . . . . . . . . . . . . 183

Overview of Cardiac Output (C.O.)

monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 7

Contents

C.O. precautions. . . . . . . . . . . . . . . . . . . . . . . . 184

Connecting the C.O. hardware. . . . . . . . . . . . . 185

Patient preparation for C.O. monitoring . . . . . . 187

Carbon Dioxide Concentrations (CO2). . . . . 189

Overview of CO2monitoring. . . . . . . . . . . . . . . 190

CO2precautions. . . . . . . . . . . . . . . . . . . . . . . . 190

Connecting the CO2sensor . . . . . . . . . . . . . . . 192

Patient preparation for CO2monitoring . . . . . . 193

CO2display . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Accessing the CO2dialog window . . . . . . . . . . 196

CO2parameter setup functions . . . . . . . . . . . . 196

System configuration. . . . . . . . . . . . . . . . . . . 199

System configuration overview. . . . . . . . . . . . . 200

Configuring general settings. . . . . . . . . . . . . . . 201

Configuring the patient settings . . . . . . . . . . . . 202

Configuring the system settings . . . . . . . . . . . . 203

Viewing the system information . . . . . . . . . . . . 205

Configuring the biomed settings . . . . . . . . . . . . 206

Configuring the screen setup . . . . . . . . . . . . . . 208

Configuring alarm settings . . . . . . . . . . . . . . . . 210

Problem solving. . . . . . . . . . . . . . . . . . . . . . . 211

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Device communication messages . . . . . . . . . . 212

M540 battery messages . . . . . . . . . . . . . . . . . . 213

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

ST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

ARR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Respiration (RRi) . . . . . . . . . . . . . . . . . . . . . . . 218

SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

IBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

CO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 235

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236

Maintenance of the IACS components . . . . . . . 237

Safety inspections . . . . . . . . . . . . . . . . . . . . . . 238

Cleaning and disinfection . . . . . . . . . . . . . . . 239

Overview of cleaning and disinfecting the

M540 and its accessories . . . . . . . . . . . . . . . . . 240

Approved cleaning agents . . . . . . . . . . . . . . . . 241

Cleaning and disinfecting the M540, M500,

and PS50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242

Cleaning and disinfecting MCables and

MPods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

Cleaning and disinfecting patient cables . . . . . 244

Cleaning and disinfecting reusable ECG lead

wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

Cleaning and disinfecting temperature

sensors and cables . . . . . . . . . . . . . . . . . . . . . 245

Cleaning NIBP cuffs . . . . . . . . . . . . . . . . . . . . 246

Cleaning and disinfecting IBP transducers

and hemodynamic pods . . . . . . . . . . . . . . . . . 246

Cleaning and disinfecting mainstream CO2

sensors and airway adapters . . . . . . . . . . . . . 247

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249

Technical data . . . . . . . . . . . . . . . . . . . . . . . . 251

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252

Infinity M540 . . . . . . . . . . . . . . . . . . . . . . . . . . 252

Infinity M500 . . . . . . . . . . . . . . . . . . . . . . . . . . 255

Power supply (PS50). . . . . . . . . . . . . . . . . . . . 256

Infinity MCable – Mainstream CO2. . . . . . . . . 257

Infinity MCable – Masimo SET and Infinity

MCable – Masimo SET Rainbow . . . . . . . . . . 258

Infinity MCable – Nellcor OxiMax . . . . . . . . . . 259

Infinity Hemo2 and Hemo4 pods . . . . . . . . . . . 260

Infinity MPod – Quad Hemo . . . . . . . . . . . . . . 261

Infinity MCable – Dual Hemo. . . . . . . . . . . . . . 262

Analog Sync MCable. . . . . . . . . . . . . . . . . . . . 263

Infinity MCable – Nurse Call . . . . . . . . . . . . . . 265

Parameter monitoring specifications . . . . . . . . 266

Electromagnetic compatibility . . . . . . . . . . . . . 281

8Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2

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Instructions for Use Infinity Acute Care System – M540 Patient Monitor SW VG2 9

For your safety and that of your patients

Strictly follow these Instructions for Use. . . . . . 10

Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Safety inspections and maintenance . . . . . . . . 10

Safety inspections . . . . . . . . . . . . . . . . . . . . . . 10

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Installing accessories . . . . . . . . . . . . . . . . . . . . 11

Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 11

Restrictions for use. . . . . . . . . . . . . . . . . . . . . . 11

Connected devices. . . . . . . . . . . . . . . . . . . . . . 11

Safe connection with other electrical

equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Networking and connection to other devices . . 11

Connection to hospital network . . . . . . . . . . . . 12

Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 12

General safety information . . . . . . . . . . . . . . 13

Not for use in areas of explosion hazard or in

oxygen-enriched areas . . . . . . . . . . . . . . . . . . . 13

Information on electromagnetic compatibility . . 14

Site of operation . . . . . . . . . . . . . . . . . . . . . . . . 14

Defibrillator precautions . . . . . . . . . . . . . . . . . . 14

Electrosurgery . . . . . . . . . . . . . . . . . . . . . . . . . 15

10 Instructions for Use Infinity Acute Care System – M540 Patient MonitorSW VG2

For your safety and that of your patients

Strictly follow these Instructions for Use

Training

Training for users is available from the responsible

Dräger organization. See www.draeger.com for

more information.

Safety inspections and maintenance

Safety inspections

The medical device must be subject to regular

safety inspections. See the chapter "Maintenance".

WARNING

Any use of the medical device requires full

understanding and strict observation of all

sections of these Instructions for Use. The

medical device must only be used for the pur-

pose specified under "Intended use"

on page 17 and in conjunction with appropri-

ate patient monitoring. Strictly observe all

WARNING and CAUTION statements through-

out these Instructions for Use and all state-

ments on medical device labels. Failure to

observe these safety information statements

constitutes a use of the medical device that is

inconsistent with its intended use.

WARNING

Every medical device must be inspected regu-

larly to ensure it remains safe to use.

This medical device must be inspected and

serviced regularly by trained technical per-

sonnel. Trained technical personnel should

also perform any repairs that are necessary.

Only authentic Dräger repair parts should be

used for maintenance. Using non-Dräger

repair parts may adversely affect the opera-

tion of the device (see the "Maintenance"

chapter). Dräger also recommends obtaining

a service contract so that all repairs are per-

formed by DrägerService.

Andere Handbücher für Infinity Acute Care System M540

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DERMAPEN

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HiB

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Carex

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Roper Rhodes

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Interacoustics

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Beurer

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ACP

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