infinity_central_station__telemetry_system_and_infi.pdf
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Instructions for Use
Infinity® CentralStation
WARNING
For a full understanding of the performance characteristics of this medical
device, the user should carefully read
this manual before use of the medical
device.
Infinity CentralStation
Infinity Telemetry System
Infinity M300
Software VF8
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This page intentionally left blank
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Instructions for Use Infinity CentralStation SW VF8
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Contents
Contents
Before You Begin . . . . . . . . . . . . . . . . . . . . . .
9
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . .
Documentation Features . . . . . . . . . . . . . . . . .
Warnings, Cautions, and Notes . . . . . . . . .
Applicability. . . . . . . . . . . . . . . . . . . . . . . . .
Device Symbols . . . . . . . . . . . . . . . . . . . . . . . .
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For Your Safety and That of Your Patient. . . 15
Strictly follow these Instructions for Use . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . .
Restriction of Distribution . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . .
General WARNINGS and CAUTIONS . . . . . . .
EU Directive 2002/96/EC (WEEE) . . . . . . .
Note on EMC/ESD risk for the devices
function . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Site of Operation. . . . . . . . . . . . . . . . . . . . .
Networking . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Safety . . . . . . . . . . . . . . . . . . . . .
Defibrillator Precautions . . . . . . . . . . . . . . .
Electrosurgery. . . . . . . . . . . . . . . . . . . . . . .
Maintenance, Modifications, and Repairs . .
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Infinity CentralStation . . . . . . . . . . . . . . . . . . 21
General Description/Product Option &
Accessory Information . . . . . . . . . . . . . . . . . . .
Infinity CentralStation . . . . . . . . . . . . . . . . .
Infinity M300 . . . . . . . . . . . . . . . . . . . . . . . .
Infinity Telemetry. . . . . . . . . . . . . . . . . . . . .
Infinity Network . . . . . . . . . . . . . . . . . . . . . . . . .
Local and Remote Patient Monitoring. . . . .
Interacting with the Infinity CentralStation Keys
User Interface . . . . . . . . . . . . . . . . . . . . . . . . .
Online Help. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Using Online Help . . . . . . . . . . . . . . . . . . .
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29
Infinity M300 . . . . . . . . . . . . . . . . . . . . . . . . . . 31
About Infinity M300. . . . . . . . . . . . . . . . . . . . . .
User Controls . . . . . . . . . . . . . . . . . . . . . . .
Starting up Infinity M300 . . . . . . . . . . . . . . . . . .
Infinity M300 Power . . . . . . . . . . . . . . . . . .
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36
36
Instructions for Use Infinity CentralStation SW VF8
Infinity M300 Parameter Displays . . . . . . . 39
Other Infinity M300 Displays . . . . . . . . . . . 40
Infinity M300 Alarm Processing . . . . . . . . . 41
Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Setting up Infinity M300 at the Infinity
CentralStation . . . . . . . . . . . . . . . . . . . . . . . . . 42
Infinity M300 Setup Screens . . . . . . . . . . . 42
Infinity M300 Setup . . . . . . . . . . . . . . . . . . . . . 43
Recordings . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Recording Types . . . . . . . . . . . . . . . . . . . . 44
Monitoring a Patient Using Infinity M300. . . . . 45
ECG Monitoring . . . . . . . . . . . . . . . . . . . . . 45
SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . 45
Infinity M300 Messages. . . . . . . . . . . . . . . . . . 46
Message Area . . . . . . . . . . . . . . . . . . . . . . 46
Infinity M300 Status Messages . . . . . . . . . 47
Infinity Telemetry Transmitter . . . . . . . . . . .
49
Transmitter Components . . . . . . . . . . . . . . . . .
Infinity TruST Telemetry Transmitter . . . . .
Lead Connector . . . . . . . . . . . . . . . . . . . . .
Programming Port Connector/Interface . .
Transmitter Buttons . . . . . . . . . . . . . . . . . .
Transmitter LED Error Patterns
(Normal Mode). . . . . . . . . . . . . . . . . . . . . .
Transmitter Operating Modes . . . . . . . . . .
Transmitter Battery . . . . . . . . . . . . . . . . . . . . .
Installing or Replacing the Battery . . . . . . .
Transmitter Setup . . . . . . . . . . . . . . . . . . . . . .
Accessing the Transmitter Setup Screen .
Received Transmitter Status Information. .
Transmitter Setup Screen Functions . . . . .
Attaching the Transmitter to the Patient . . . . .
Transmitter Messages . . . . . . . . . . . . . . . . . . .
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Infinity CentralStation Setup . . . . . . . . . . . .
59
Accessing the Setup Screens . . . . . . . . . . . . .
Password-Protected Screens . . . . . . . . . .
Setup - Central Screen . . . . . . . . . . . . . . . . . .
Setup - Recorder Screen. . . . . . . . . . . . . . . . .
Setup - Central Layouts Screen . . . . . . . . . . .
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Contents
Infinity M300 System Setup . . . . . . . . . . . . . . 65
Patient Setup - Bed View . . . . . . . . . . . . . . . 107
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessing the Telemetry Setup Screens . .
Changing the System Default Patient
Category . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infinity M300 System Setup Screen . . . . . . . . .
Infinity M300 Patient View Defaults Setup
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infinity M300 ST Defaults Setup . . . . . . . . . . . .
Infinity M300 Alarm Limits Defaults Screen . . .
Infinity M300 Arrhythmia Defaults Screen . . . .
Available Functions on the Arrhythmia
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infinity M300 Find Device . . . . . . . . . . . . . . . . .
General Bed View Setup . . . . . . . . . . . . . . . . .
Accessing a Patient’s Bed View Screen . . . . .
Bed View Screen Layout . . . . . . . . . . . . . . . . .
Waveform Assignment. . . . . . . . . . . . . . . .
Bed View Menu Bar . . . . . . . . . . . . . . . . . .
Bed View Submenu Selections . . . . . . . . .
Information Area . . . . . . . . . . . . . . . . . . . .
Waveform Area . . . . . . . . . . . . . . . . . . . . .
Putting Monitoring Into Standby Mode. . . .
Parameter Areas in Bed View . . . . . . . . . . . . .
Bed View Screen Display . . . . . . . . . . . . . . . .
Selecting the Bed View . . . . . . . . . . . . . . .
Bed View Review Screens . . . . . . . . . . . . . . .
Alarm Limits and Arrhythmia Setup. . . . . . . . .
Configuring Alarm Limits . . . . . . . . . . . . . .
Configuring Arrhythmia Setup . . . . . . . . . .
Telemetry Setup Screens . . . . . . . . . . . . . . . .
Accessing the Telemetry Setup Screens . .
Infinity TruST 12-Lead Monitoring Option . . . .
Use of TruST Reference ECG . . . . . . . . . .
Patient View Setup Chest Lead Selection .
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79
Infinity Telemetry System Setup . . . . . . . . . . 81
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Accessing the Telemetry Setup Screens . . 82
Changing the System Default Patient
Category . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Infinity Telemetry System Setup Screen . . . 83
Infinity Telemetry Patient View Defaults Setup
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Infinity Telemetry ST Defaults Setup . . . . . . . .
Infinity Telemetry Recordings Setup Screen . .
Recordings Setup Screen Functions . . . . .
Infinity Telemetry Alarm Limits Defaults Screen
Infinity Telemetry Arrhythmia Defaults Screen .
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90
Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Main Screen Layout . . . . . . . . . . . . . . . . . . . . . 94
Split vs. Full Main Screen . . . . . . . . . . . . . . . . . 94
Selecting a Main Screen Layout . . . . . . . . . 95
Main Screen Setup. . . . . . . . . . . . . . . . . . . . . . 95
Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Waveform Area - Patient Window. . . . . . . . 96
Stopping Waveforms. . . . . . . . . . . . . . . . . . 99
Waveform Color . . . . . . . . . . . . . . . . . . . . . 99
Telemetry Waveform Dropout Display
(Infinity Telemetry only). . . . . . . . . . . . . . . . 100
Parameter Areas. . . . . . . . . . . . . . . . . . . . . 100
Notes Area . . . . . . . . . . . . . . . . . . . . . . . . . 102
Status Area . . . . . . . . . . . . . . . . . . . . . . . . . 102
Manual Waveform - Configuration Mode . . . . . 103
Main Screen - Status Area Messages . . . . . . . 104
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Admit/Discharge/Transfer. . . . . . . . . . . . . . . 119
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Admitting a Patient . . . . . . . . . . . . . . . . . . . . .
Entering Patient Demographics. . . . . . . . . . . .
Changing Patient Category . . . . . . . . . . . .
Admitting Wireless Monitor Patients . . . . . . . .
Moving Between Wired and Wireless
Communication . . . . . . . . . . . . . . . . . . . . .
Wireless Transmission Interruption . . . . . .
Admitting Under Special Conditions . . . . . . . .
Discharging a Patient . . . . . . . . . . . . . . . . . . .
The Patient Transfer Function . . . . . . . . . . . . .
Special Data Transfer Conditions . . . . . . .
Transferring Data to the Infinity
CentralStation . . . . . . . . . . . . . . . . . . . . . .
Transferring Data From the Infinity
CentralStation . . . . . . . . . . . . . . . . . . . . . .
Transfer Messages . . . . . . . . . . . . . . . . . .
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Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pacemaker and TENS Precautions . . . . . .
About the Arrhythmia Template . . . . . . . . . . . .
Relearning the Template . . . . . . . . . . . . . . . . .
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Instructions for Use Infinity CentralStation SW VF8
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Contents
Customizing a Patient’s Arrhythmia Setup . . . . 133
Accessing the Arrhythmia Setup Table . . . . 133
Available Functions on the Arrhythmia
Setup Table. . . . . . . . . . . . . . . . . . . . . . . . . 133
Available Bedside Event Settings. . . . . . . . . . . 135
Arrhythmia Beat and Rhythm Classification . . . 136
Telemetry Pulse Oximetry and NIBP
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Pulse Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . 140
Sensor Application . . . . . . . . . . . . . . . . . . . . . . 141
Turning Pulse Oximetry Monitoring On/Off. . . . 142
Display of Pulse Oximeter Information . . . . 142
Vital Connection Cable . . . . . . . . . . . . . . . . . . . 142
Getting an NIBP or SpO2 measurement . . . 143
Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . 145
Alarm Messages. . . . . . . . . . . . . . . . . . . . . . . . 145
SpO2 Alarm Messages via Infinity
Telemetry and Infinity M300 . . . . . . . . . . . . 145
Telemetry ST Analysis Option. . . . . . . . . . . . 149
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
ST Segment Morphology . . . . . . . . . . . . . . 150
Parameter Display . . . . . . . . . . . . . . . . . . . . . . 151
Relearning ST. . . . . . . . . . . . . . . . . . . . . . . . . . 151
ST Points Setup Screen . . . . . . . . . . . . . . . . . . 151
Hexaxial (Cabrera) Lead Support . . . . . . . . 151
Accessing the ST Points Setup Screen . . . 152
Display Order of ST Complexes . . . . . . . . . 153
Available Functions on ST Points Setup
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Telemetry ST Setup Screen . . . . . . . . . . . . . . . 155
Accessing the Telemetry ST Setup Screen 155
ST Alarm Messages . . . . . . . . . . . . . . . . . . . . . 156
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Alarm Validation - Infinity Telemetry . . . . . . 158
Alarm Validation - Infinity M300 . . . . . . . . . 159
Alarm Grades . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Latching alarms . . . . . . . . . . . . . . . . . . . . . 160
Non-latching Alarms . . . . . . . . . . . . . . . . . . 160
The Surveillance Feature . . . . . . . . . . . . . . . . . 161
Display of Surveillance Alarm Messages . . 161
Audible Alarm Signals. . . . . . . . . . . . . . . . . 162
MIB Ventilator Alarms . . . . . . . . . . . . . . . . . . . . 163
Instructions for Use Infinity CentralStation SW VF8
Alarm Groups . . . . . . . . . . . . . . . . . . . . . . . . .
Silencing Alarms . . . . . . . . . . . . . . . . . . . . . . .
Silencing Local Alarms . . . . . . . . . . . . . . .
Configuring a Patient’s Alarm Setup . . . . . . . .
Opening the Alarm Limits Setup Screen . . . . .
Pausing Alarms . . . . . . . . . . . . . . . . . . . . .
Changing a Parameter’s Alarm Limits . . . .
Turning Alarm Recordings ON/OFF. . . . . .
Turning Event Storage On/Off . . . . . . . . . .
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170
Recordings / Reports . . . . . . . . . . . . . . . . . . 171
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Laser Printers . . . . . . . . . . . . . . . . . . . . . . . . .
Processing of Strip Recordings . . . . . . . . . . . .
Active Recordings . . . . . . . . . . . . . . . . . . .
Pending Recordings . . . . . . . . . . . . . . . . .
Requesting a Remote Recording. . . . . . . .
Recorder Setup . . . . . . . . . . . . . . . . . . . . . . . .
Replacing the Recorder Paper . . . . . . . . .
Setting up a Recording . . . . . . . . . . . . . . .
Recording Types . . . . . . . . . . . . . . . . . . . . . . .
Timed Recordings . . . . . . . . . . . . . . . . . . .
Continuous Recordings . . . . . . . . . . . . . . .
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Simultaneous ECG Report . . . . . . . . . . . .
Full Disclosure Strip Report . . . . . . . . . . . .
Full Disclosure Hour Report. . . . . . . . . . . .
Full Disclosure 24 Hour Report . . . . . . . . .
Event Disclosure Strip Reports . . . . . . . . .
Shift Report . . . . . . . . . . . . . . . . . . . . . . . .
Graphical Trend Report . . . . . . . . . . . . . . .
Selected Strip Report. . . . . . . . . . . . . . . . .
Selected Events Report . . . . . . . . . . . . . . .
ECG Caliper Report. . . . . . . . . . . . . . . . . .
Ventilator Report . . . . . . . . . . . . . . . . . . . .
Requesting Recordings and Reports . . . . . . .
Canceling a Recording . . . . . . . . . . . . . . . . . .
Actions that Affect Recordings . . . . . . . . . . . .
Recording Status Messages . . . . . . . . . . . . . .
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Trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessing a Patient’s Trends . . . . . . . . . . . . .
Trend Graphs . . . . . . . . . . . . . . . . . . . . . . . . .
Parameter Trend Scale Defaults for
Telemetry Patients . . . . . . . . . . . . . . . . . . .
Trend Table . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trend Cursor . . . . . . . . . . . . . . . . . . . . . . . . . .
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Contents
Representation of Special Conditions . . . . . . . 207
Full/Event Disclosure. . . . . . . . . . . . . . . . . . . 209
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Full/Event Disclosure Census Operations . . . . 210
Accessing the Census Screen . . . . . . . . . . 210
Admitting a Patient to Full/Event Disclosure . . 213
Data Collection Rules . . . . . . . . . . . . . . . . . 213
Admitting a Patient on the Census screen . 214
Accessing Disclosure History . . . . . . . . . . . . . . 214
Locking a Full/Event Disclosure Record . . . 214
Accessing the Full/Event Disclosure Review
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Full Disclosure Review Screen. . . . . . . . . . . . . 216
Event Disclosure Review Screen . . . . . . . . . . . 217
Full/Event Disclosure Review Screen
Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Annotating Events. . . . . . . . . . . . . . . . . . . . 222
Viewing Events . . . . . . . . . . . . . . . . . . . . . . 223
Deleting Events. . . . . . . . . . . . . . . . . . . . . . 224
Viewing Parameter Values . . . . . . . . . . . . . 224
Renaming/Reclassifying Events . . . . . . . . . 225
Disclosure Review Screen Cursor . . . . . . . 226
ECG Caliper Tool . . . . . . . . . . . . . . . . . . . . . . . 227
Caliper Measure Screen . . . . . . . . . . . . . . . 228
Caliper Review Screen . . . . . . . . . . . . . . . . 231
Full and Event Disclosure Reports . . . . . . . . . . 233
Exporting Full/Event Disclosure Data . . . . . . . . 234
Exporting Full Disclosure Data to a
Third-Party Device . . . . . . . . . . . . . . . . . . . 234
Exporting Events from Event Disclosure . . 234
Special Conditions . . . . . . . . . . . . . . . . . . . . . . 235
VentCentral Option. . . . . . . . . . . . . . . . . . . . . 237
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
The Ventilator Screen. . . . . . . . . . . . . . . . . . . . 239
Accessing the Ventilator Screen . . . . . . . . . 240
Waveform Area in Ventilator Screen. . . . . . 240
Loops Area in Ventilator Screen . . . . . . . . . 240
Trend Area in Ventilator Screen . . . . . . . . . 241
The Ventilator Settings Review Screen . . . . . . 242
Accessing the Ventilator Settings Review
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Parameter and Settings Order . . . . . . . . . . 243
Special Conditions . . . . . . . . . . . . . . . . . . . 243
Ventilator View Setup Screen . . . . . . . . . . . . . . 244
Accessing the Ventilator View Setup
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
6
Selecting Waveforms for Display. . . . . . . .
Selecting Waveforms for the Trend
Display. . . . . . . . . . . . . . . . . . . . . . . . . . . .
MIB Ventilator Alarms . . . . . . . . . . . . . . . . . . .
Ventilator Report . . . . . . . . . . . . . . . . . . . . . . .
VentCentral Messages . . . . . . . . . . . . . . . . . .
Ventilator and Device Messages/Labels . . . . .
Dräger Cato Anesthesia System . . . . . . . .
Dräger Cicero Series Anesthesia
Systems . . . . . . . . . . . . . . . . . . . . . . . . . .
Dräger Julian Anesthesia System . . . . . . .
Dräger Primus Anesthesia System . . . . . .
Dräger Narkomed 6000/64000 System . . .
Dräger Fabius Tiro / GS Anesthesia
Systems. . . . . . . . . . . . . . . . . . . . . . . . . . .
Dräger Fabius CE Anesthesia System . . .
Dräger Zeus Anesthesia System . . . . . . . .
Dräger Babylog 8000 Ventilator. . . . . . . . .
Dräger Evita 2 Ventilator . . . . . . . . . . . . . .
Dräger Evita 2 Dura/4/XL Ventilator . . . . .
Dräger Savina Ventilator . . . . . . . . . . . . . .
Ohmeda Modulus CD Anesthesia
System. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Puritan-Bennett 7200/840 Ventilators . . . .
Taema Horus Ventilator . . . . . . . . . . . . . . .
Hamilton Galileo Ventilator . . . . . . . . . . . .
Maquet SV 300/SV 300A/Servoi Ventilator
Maquet SV 900 Ventilator . . . . . . . . . . . . .
Viasys Bear 1000 Adult Ventilator . . . . . . .
Viasys BearCub Infant Ventilator . . . . . . . .
Baxter Vigilance/Vigilance II Cardiac
Output Monitor . . . . . . . . . . . . . . . . . . . . . .
etCO2/Respiratory Mechanics Pod . . . . . .
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247
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248
249
250
251
252
255
256
258
259
262
264
266
271
274
274
276
278
279
281
282
284
286
287
Biomed Functions . . . . . . . . . . . . . . . . . . . . . 289
Biomed Screen Selections . . . . . . . . . . . . . . .
Accessing the Biomed Screens . . . . . . . . .
Show Devices Screen . . . . . . . . . . . . . . . . . . .
Configure Central Screen . . . . . . . . . . . . . . . .
Editing Event Class Names . . . . . . . . . . . .
Modifying the Configure Central
selections. . . . . . . . . . . . . . . . . . . . . . . . . .
Configure Locked Options Screen . . . . . . . . .
Enabling Available Options . . . . . . . . . . . .
Raid Option . . . . . . . . . . . . . . . . . . . . . . . . . . .
System Console . . . . . . . . . . . . . . . . . . . . . . .
Rest ECG Reports. . . . . . . . . . . . . . . . . . . . . .
Available Report Formats . . . . . . . . . . . . .
290
290
290
291
293
293
294
294
294
295
295
296
Instructions for Use Infinity CentralStation SW VF8
Page 7
Contents
Accessing the Rest ECG Report
Selection Menu . . . . . . . . . . . . . . . . . . . . . . 297
Viewing Logs . . . . . . . . . . . . . . . . . . . . . . . . . . 298
Copying Logs . . . . . . . . . . . . . . . . . . . . . . . 298
Telemetry System Set Up . . . . . . . . . . . . . . . . . 299
Infinity M300 Set Up . . . . . . . . . . . . . . . . . . 299
Infinity Telemetry Set Up. . . . . . . . . . . . . . . 301
Radio Frequency Diagnostics . . . . . . . . . . . . . 304
Available Information on the RF
Diagnostics Screen. . . . . . . . . . . . . . . . . . . 304
Patient Preparation. . . . . . . . . . . . . . . . . . . . . 305
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306
ECG Electrode Placement . . . . . . . . . . . . . . . . 306
Lead Wire Color Codes . . . . . . . . . . . . . . . 308
Attaching the Pulse Oximeter . . . . . . . . . . . . . . 308
Technical Specifications . . . . . . . . . . . . . . . . 309
Infinity CentralStation . . . . . . . . . . . . . . . . . . . . 310
Site of Operation. . . . . . . . . . . . . . . . . . . . . 310
Touch Screen Display . . . . . . . . . . . . . . . . . . . 312
Uninterruptible Power Supply . . . . . . . . . . . . . . 313
Uninterruptible Power Supply (Japan) . . . . . . . 315
Infinity M300 . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
Infinity M300 Bedside Charger . . . . . . . . . . . . . 321
Infinity M300 Central Charger . . . . . . . . . . . . . 322
Infinity TruST Telemetry System. . . . . . . . . . . . 323
Electromagnetic Compatibility . . . . . . . . . . . . . 327
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335
Cleaning the Infinity CentralStation . . . . . . . . . 336
Cleaning and Disinfecting Infinity Telemetry
and Infinity M300 . . . . . . . . . . . . . . . . . . . . . . . 336
Recommended Cleaning Agents . . . . . . . . 336
Patient Cables . . . . . . . . . . . . . . . . . . . . . . 336
Reusable ECG Electrodes . . . . . . . . . . . . . 337
Reusable SpO2 Sensor . . . . . . . . . . . . . . . 337
Cleaning the MicrO2/MicrO2+® Oximeter . . . . 337
Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . 337
Reusable Sensor . . . . . . . . . . . . . . . . . . . . 337
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339
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8
Instructions for Use Infinity CentralStation SW VF8
Page 9
Before You Begin
Before You Begin
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Documentation Features . . . . . . . . . . . . . . . . 12
Warnings, Cautions, and Notes . . . . . . . . . . . . 12
Applicability. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Device Symbols . . . . . . . . . . . . . . . . . . . . . . . 13
Instructions for Use Infinity CentralStation SW VF8
9
Page 10
Before You Begin
Intended Use
The Infinity CentralStation is intended for use by
healthcare professionals for the purpose of centralized monitoring within the hospital or clinical environment of adult, pediatric and neonatal patient
monitor data on the Infinity patient monitoring network. The Infinity CentralStation is intended to
measure and produce visual and audible alarms for
one or more physiological parameters. The Infinity
CentralStation with Rest ECG can provide interpretive diagnostic statements and reports for adults
and pediatric patients when connected to a monitor
with ECG monitoring capability.
Infinity M300 Telemetry System is intended to be
used by healthcare professionals for the purpose of
monitoring ECG and pulse oximetry parameters of
ambulatory and non-ambulatory adult and pediatric
patients in healthcare facilities. Infinity M300 is
intended to operate with the Infinity CentralStation
using wireless communication over the Infinity
patient monitoring network.
NOTE
The Infinity CentralStation, Infinity Telemetry
receiver, and Infinity M300 Central Charger are not
intended for use in the patient vicinity.
This device complies with part 15 of the FCC rules.
Operation is subject to the following two conditions:
– This device may not cause harmful interference.
– This device must accept any interference
received, including interference that may
cause undesired operation.
Infinity Telemetry System is intended for use in an
environment where patient care is provided by
healthcare professionals (physicians, nurses, technicians) when the professional determines that a
device is required to measure and produce visual
and audible alarms for adult and pediatric patient
populations. Infinity Telemetry System transmits via
radio frequency physiological signals for display
and/or measurement at the Infinity CentralStation.
The Infinity CentralStation Telemetry System with
TruST is intended for 12-Lead ECG monitoring with
a reduced set of electrodes. Reconstructed leads
are intended for real-time assessment of ST segment changes.
CAUTION
All Dräger hardware and screen shots shown in
this manual are examples only. Actual product or
screens may differ slightly.
10
Instructions for Use Infinity CentralStation SW VF8
Page 11
Before You Begin
Introduction
Before using all Dräger devices, read all provided
documentation carefully.
WARNING
Using software not approved by Dräger on the
CPU of the Infinity CentralStation may
adversely affect operation of the Infinity Network.
Diagnosis based on interpretation of 12-lead
monitoring results should only be done by
qualified personnel. Prior to final interpretation and diagnosis, qualified physicians
should review suggested diagnostic statements and all other available information.
Trademarks
Infinity®, MultiMed®, Pick and Go®, VentCentral®,
TruST®, ACE® (Arrhythmia Classification Expert),
and DrägerService® are registered trademarks of
Dräger Medical GmbH.
Unpublished rights reserved under the copyright
laws of the United States
RESTRICTED RIGHTS LEGEND Use duplication
or disclosure by the Government is subject to
restrictions as set forth in subparagraph (c)(1)(ii) of
the Rights in Technical Data & Computer Software
clause at DFARS 252 227:7013
All other brand or product names are trademarks or
registered trademarks of their respective companies.
Instructions for Use Infinity CentralStation SW VF8
11
Page 12
Before You Begin
Documentation Features
Warnings, Cautions, and Notes
Definitions
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 information about a potentially hazardous situation which,
if not avoided may result in minor or moderate
injury to the user or patient, or in damage to the
equipment or other property.
NOTE
A note provides additional information intended to
avoid inconvenience during operation.
Applicability
For applicability of discontinued product names,
(e.g. Infinity SC 7000, Infinity SC 8000, Infinity SC
9000XL) see the current Infinity Network Software
Compatibility Chart.
12
Instructions for Use Infinity CentralStation SW VF8
Page 13
Before You Begin
Device Symbols
Marking on various Infinity CentralStation hardware
components may include the following:
Consult accompanying documents
Display On/Off button
CPU On/Off LED
IPX7
Protected against the effects of immersion
IPX4
Protected against splashing water
IPX1
Protected against dripping water
IPX0
Non-protected against water
Defibrillator-proof equipment, type CF
IC: 267I-ABTU4
Canadian certification (The term “IC:” before the radio certification number only signifies that Industry Canada technical specifications were met.)
Observe WEEE (Waste Electrical and Electronic Equipment) disposal
requirements (12)
Complies with the European Medical Device Directive 93/42/EEC for
medical devices
Instructions for Use Infinity CentralStation SW VF8
13
Page 14
Before You Begin
Danger: Risk of explosion if used in presence of flammable anesthetics
Tested to comply with FCC standards
USB connector
14
Instructions for Use Infinity CentralStation SW VF8
Page 15
For Your Safety and That of Your Patient
For Your Safety and That of Your Patient
Strictly follow these Instructions for Use . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restriction of Distribution . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
16
16
16
16
General WARNINGS and CAUTIONS . . . . . . 16
EU Directive 2002/96/EC (WEEE) . . . . . . . . . .
Note on EMC/ESD risk for the devices
function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Site of Operation. . . . . . . . . . . . . . . . . . . . . . . .
Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . .
Defibrillator Precautions . . . . . . . . . . . . . . . . . .
Electrosurgery . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance, Modifications, and Repairs. . . . .
Instructions for Use Infinity CentralStation SW VF8
17
17
17
18
18
19
19
19
15
Page 16
For Your Safety and That of Your Patient
Strictly follow these Instructions for Use
WARNING
To maintain patient safety, adhere to all
WARNINGS and CAUTIONS listed in these
Instructions for Use and on equipment labels.
Accessories
WARNING
These Instructions for Use list the accessories
that have been tested and are approved for
use with the device. Using any other accessories may adversely affect the operation of the
device. Contact your local Dräger representative for a current list of approved accessories.
Restriction of Distribution
The Infinity Telemetry System complies with the
Radio Equipment and Telecommunications Terminal Equipment Directive (1999/5/EC).
Patient monitoring equipment, however sophisticated, should never be used as a substitute for the
human care, attention, and critical judgment that
only trained health care professionals can provide.
CAUTION
Federal Law (U.S) restricts these devices to sale
by or on the order of a physician.
CAUTION
These devices are for use in health care facilities
only and exclusively by persons with specific
training and experience in its use.
Patient safety
The design of the equipment, the accompanying literature, and the labeling on the equipment consider
that the purchase and use of the equipment is
restricted to trained professionals, and that certain
inherent characteristics of the equipment are
known to the trained operator. Instructions, warning, and caution statements are limited, therefore,
largely to the specifics of the Dräger design.
This publication excludes references to various
hazards which are obvious to a medical professional and operator of this equipment, to the consequences of product misuse, and to potentially
adverse effects in patients with abnormal conditions. Product modification or misuse can be dangerous.
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to
general operation of the devices. WARNINGS and
CAUTIONS specific to subsystems or particular
features appear with those topics in later sections
of the manual.
WARNING
For the devices to be properly grounded, connect the power cord to a hospital-grade outlet.
16
WARNING
To avoid explosions, devices should not be
used in the presence of flammable anesthetic
mixture including oxygen, ether, nitrous
oxide, or cyclopropane.
WARNING
To minimize the risk of patient strangulation,
carefully place and secure all patient cables
away from the patient’s neck and face.
Instructions for Use Infinity CentralStation SW VF8
Page 17
For Your Safety and That of Your Patient
CAUTION
Follow local regulations for safe disposal of batteries. To prevent fire or explosion, never dispose
of batteries in fire.
EU Directive 2002/96/EC (WEEE)
These devices are subject to EU Directive
2002/96/EC (WEEE). They are not registered for
use in private households, and may not be disposed of at municipal collection points for waste of
electrical and electronic equipment. Dräger Medical
has authorized a firm to dispose of these devices in
the proper manner. For more detailed information,
please contact your local Dräger Medical organization.
Note on EMC/ESD risk for the devices
function
Electromedical devices are subject to special precautionary measures concerning EMC and must be
installed and put into operation in accordance with
the EMC information described on page 327. Additional information is available from DrägerService
on request.
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING
Do not operate the devices in areas such as:
magnetic resonance imaging (MRI) environments, aircraft, ambulance, home or hyperbaric chambers.
Instructions for Use Infinity CentralStation SW VF8
WARNING
Connector pins with an electrostatic discharge (ESD) warning
sign should not be touched and no
connections should be made
between these connectors without
implementing ESD protective measures. Such
precautionary procedures may include antistatic clothing and shoes, the touch of a
ground stud before and during connecting the
pins or the use of electrically isolating and
antistatic gloves. All staff involved in the
above should receive instruction in these ESD
precautionary procedures.
CAUTION
To prevent equipment failure, do not use wireless
phones and radios within 33 feet (10 m) of the
equipment.
Site of Operation
Only use devices (monitor, pods, modules and
accessories) in areas that meet the environmental
requirements outlined in the section beginning on
page 309.
WARNING
Do not operate medical devices (monitor,
pods, modules and accessories) in close
proximity to equipment that emits microwave
or other high-frequency emissions which may
interfere with the medical devices’ operation.
WARNING
To avoid electric shock, inspect all cables
before use. Never use cables that appear
cracked, worn, or damaged in any way (doing
so may compromise performance or put the
patient at risk).
17
Page 18
For Your Safety and That of Your Patient
CAUTION
When placing devices, make sure adequate ventilation exists and prevent overheating by positioning the devices with at least 2 inches (5 cm) of
space around all sides, if possible.
CAUTION
To avoid short-circuiting and otherwise damaging
the devices, do not allow fluids to come in contact
with the device when it is connected to a power
outlet. If fluids are accidentally spilled on the
equipment, remove the affected unit from service
as soon as possible and contact the service personnel to verify that patient safety is not compromised.
Networking
When networking with electrical devices, the operator is responsible for ensuring that the resulting
system meets the requirements set forth by the following standards:
–
IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
–
IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
–
IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
–
IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Electrical Safety
WARNING
Because of the danger of electric shock, never
remove the cover of a device while it is in
operation or connected to a power outlet.
WARNING
Any connected devices, or combination of
devices, not complying with the requirements
in these Instructions for Use may adversely
affect the operation of the Infinity CentralStation and/or Infinity M300. Before using the
Infinity CentralStation and/or Infinity M300
with other devices, consult the accompanying
documentation of all connected devices.
Only equipment tested and approved by
Dräger should be connected to the Infinity
Network. Failure to do so may adversely affect
operation of the Infinity Network.
CAUTION
Electrical connections to equipment not listed in
these Instructions for Use should only be made
following consultation with the respective manufacturers. Equipment malfunction may result with
the risk of patient injury.
CAUTION
To avoid injuring the patient, do not touch any connector or mounting screw on the device when you
are touching the patient. In addition, do not allow
the conductive parts of electrodes and cables to
contact other conductive parts or ground.
Strictly follow the Instructions for Use for each networked device.
18
Instructions for Use Infinity CentralStation SW VF8
Page 19
For Your Safety and That of Your Patient
Defibrillator Precautions
Maintenance, Modifications, and Repairs
The Infinity M300 and Infinity Telemetry transmitter
are protected against high-frequency interference
from defibrillators and electrosurgical units and
against 50- and 60-Hz power line interference.
WARNING
Operation of the device should be in accordance with part 15.242 sections A, D, E, F, G,
and H of the FCC rules.
WARNING
To protect the monitor from damage during
defibrillation, for accurate ECG information,
and to protect against noise and other interference, use only ECG electrodes and cables
specified by Dräger. Other sensors may not
provide adequate protection against defibrillation.
Safety requires regular equipment inspection and
maintenance. Be sure that devices are used and
serviced in accordance with Dräger Service Documentation: “Preventative Maintenance Procedure”
and “Preventative Maintenance Schedule.”
CAUTION
To prevent burns and electric shock due to rerouting of electrical current through electrodes, do not
position the defibrillator pads near any electrodes
or sensors.
CAUTION
Only defibrillate across the chest.
Electrosurgery
Observe the following precautions during electrosurgery to minimize electrosurgical unit (ESU)
interference and maximize operator and patient
safety.
WARNING
For better performance and to reduce the hazard of burns during surgery, always use
accessories designed for ESU environments.
Do not use skin temperature probes.
WARNING
To reduce the hazard of burns during electrosurgery, keep the sensor or transducer (ECG,
pressure, SpO2) and their associated cables
away from the surgical site, the ESU return
electrode, and earth ground.
Instructions for Use Infinity CentralStation SW VF8
CAUTION
Using accessories beyond the life span recommended by the manufacturer may compromise
patient safety due to device failure.
This service documentation and a full technical
description of the Infinity Network are available
from your local Dräger representative.
An effective maintenance schedule should be
established for your monitoring equipment and
reusable supplies. This should include inspection,
as well as general cleaning, on a regular basis. The
maintenance schedule must comply with the policies of your hospital infection control department or
biomedical department. Check with your biomedical maintenance to be sure preventative maintenance and calibration is complete.
Once a year, check all cables, devices, and accessories for damage, ground resistance, chassis and
patient leakage currents, and all alarm functions.
Also, ensure that all safety labels are legible. Maintain a record of safety inspections. Safety checks,
device verification, calibration, and maintenance
should be carried out and verified by properly
trained personnel.
19
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For Your Safety and That of Your Patient
WARNING
Repair of the device may only be carried out
by trained service personnel. Regular annual
maintenance (functional and safety test)
according to IEC 60601-1 is recommended,
regardless of national regulations or laws (for
example, accident prevention regulations).
Connecting this medical device to other medical devices could result in additional maintenance requirements. Consult the
documentation for these other devices or software to identify additional requirements.
Dräger recommends contracting with
DrägerService for any repairs. Use only
authentic Dräger repair parts during maintenance. Using non-Dräger repair parts may
adversely affect the operation of the device
(see the “Maintenance” chapter).
Maintenance Intervals
Task
Interval
By whom
Device Service
2 years
and Maintenance
Authorized
technician
Replace Hard
Drives (without
RAID option)
4 years
Authorized
technician
Replace Hard
Drives (with
RAID option)
When
necessary
Authorized
technician
M300 Battery
1 year
Technical
Personnel
Clean Optional
ICS Air Filters
2 months
Medical or Tech
Personnel
20
Instructions for Use Infinity CentralStation SW VF8
Page 21
Infinity CentralStation
Infinity CentralStation
General Description/Product Option &
Accessory Information. . . . . . . . . . . . . . . . . . 22
Infinity CentralStation . . . . . . . . . . . . . . . . . . . . 22
Infinity M300 . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Infinity Telemetry. . . . . . . . . . . . . . . . . . . . . . . . 24
Infinity Network. . . . . . . . . . . . . . . . . . . . . . . . 24
Local and Remote Patient Monitoring . . . . . . . 26
Interacting with the Infinity CentralStation
Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . 27
Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Using Online Help. . . . . . . . . . . . . . . . . . . . . . . 29
Instructions for Use Infinity CentralStation SW VF8
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Page 22
Infinity CentralStation
General Description/Product Option & Accessory Information
Infinity CentralStation
Infinity CentralStation provides centralized monitoring and critical care management for bedside and
telemetry monitored patients. From the Infinity CentralStation, clinicians can gain access to patient
information for patients on the Infinity Network. The
Infinity CentralStation displays waveforms, parameters, and alarm status of Infinity bedside monitors,
Infinity M300, Infinity Telemetry, and ventilators (via
an etCO2 pod or an MIB interface) for up to 16
patients on a single screen or up to 32 patients
using two screens. The standard Infinity CentralStation includes the following features:
–
Central Processing Unit (CPU)
–
Configurable Main Screen display
–
Audio alarm annunciation
–
2-hour storage of 4-waveform Full Disclosure
–
2-hour storage of up to 1000 events per patient
–
Export of waveforms
–
24- or 72-hour graphical and tabular trends
–
Accessory Kit
–
Instructions for Use (paper and online .PDF in
application)
–
one or two PC displays, or touch screens
–
external speakers,
–
mouse and keyboard
–
optional remote displays
–
2-channel R50-N recorder
–
network laser printer
–
uninterruptible power supply
–
Infinity Network components
22
Options for the Infinity CentralStation include:
–
Second video
–
RAID 1 for storage disk
–
CPU mounting package
–
Patient licenses to support 32-patients
–
28-, 48-, or 72-hour Full and Event Disclosure
–
Expanded Full Disclosure
–
VentCentral™
–
Patient Census
–
Rest ECG Analysis
–
Infinity Telemetry
–
Infinity M300
–
ST Analysis
–
TruST 12-lead
–
Infinity Paging Interface for alarm notification
via Infinity Gateway Suite
–
Infinity Symphony for web-based review of
stored data
–
Infinity WebViewer and Infinity Pocket WinView
for near real-time review of patient data
–
HL7 bi-directional interfacing via Infinity Gateway Suite
Instructions for Use Infinity CentralStation SW VF8
Page 23
Infinity CentralStation
Infinity M300
Infinity M300 is a patient worn transceiver that uses
the Infinity CentralStation as the primary patient
monitoring display and primary alarm source. The
Infinity M300 device includes a color display, local
alarm alerts and rechargeable internal battery.
Infinity M300 use is restricted to one patient at a
time. The standard Infinity M300 includes the following features:
–
Infinity M300 patient worn device
–
Infinity M300 Bedside Charger
–
Infinity M300 Central Charger
–
Infinity M300 programming kit
–
ECG lead sets
–
Infinity CentralStation
Instructions for Use Infinity CentralStation SW VF8
Options for the Infinity M300 include:
–
Infinity CentralStation options, as indicated on
page 22
–
Pulse Oximetry software enabled at Infinity
CentralStation
–
Pulse Oximetry cables and sensors
–
Infinity M300 Replacement battery
–
Infinity M300 disposable pouches
–
Infinity M300 shower pouches
–
Infinity M300 bedside clips
23
Page 24
Infinity CentralStation
Infinity Telemetry
Infinity Telemetry is a patient worn transmitter that
uses the Infinity CentralStation as the primary
patient monitoring display and primary alarm
source. The Infinity Telemetry device is lightweight,
water resistant, and uses disposable 9V batteries.
Infinity Telemetry use is restricted to one patient at
a time. The standard Telemetry includes the following features:
Options for the Infinity Telemetry include:
–
Infinity CentralStation options, as indicated on
page 22
–
MicrO2+ Pulse Oximeter and connection cable
–
VitalConnection cable for Non-invasive Blood
pressure
–
Non-invasive Blood pressure hoses and cuffs
–
Infinity Telemetry Receiver CPU
–
SpO2 measurements
–
Infinity Telemetry Receiver Expansion Kits
–
Analog ECG cable
–
Infinity Telemetry UHF or VHF antenna components
–
Pulse Oximetry cables and sensors
–
Infinity Telemetry Transmitters
–
9V disposable batteries or disposable lithium
ion batteries
–
Infinity Telemetry programming kit
–
Infinity Telemetry disposable pouches
–
ECG lead sets
–
Infinity CentralStation
Infinity Network
The Infinity Network is a standards-based network
providing connectivity and data access among
Infinity devices.
The Infinity Network can include wired and wireless
components.
For detailed information about the configuration,
installation and operation of components in the
Infinity Network, contact your local Dräger
representative.
WARNING
Loss of communication between the Infinity
CentralStation and the bedside monitor is
possible. Dräger recommends using the bedside monitor for primary diagnosis and the
Infinity CentralStation for patient viewing.
NOTE
Please refer to manufacturer’s documentation for
hazards associated with wireless components.
24
Instructions for Use Infinity CentralStation SW VF8
Page 25
Infinity CentralStation
WARNING
– The Infinity CentralStation CPU and its display(s) must always stay on. Never press
any of the On/Off buttons to turn the CPU
or the display(s) off.
–
The Infinity CentralStation CPU must be
placed so that it can be heard easily if the
external speakers become non-functional.
You must keep the Infinity CentralStation
external speakers connected at all times.
–
KeyboardVideoMouse (KVM) extenders
tested to be compatible with the Infinity
CentralStation may be used. KVM extenders, as with any peripheral of the Infinity
CentralStation, require good judgement
and maintenance checks to ensure that all
peripherals are connected properly and in
working condition. When using a KVM
extender, the internal speakers within the
Infinity CentralStation CPU may not be
heard in the event of a KVM disconnection.
When using a KVM extender, it is recommended that the hospital implement a routine maintenance procedure to check the
integrity of the KVM extender audio cable
connection. In the event a visual alarm is
present without an audible alarm, check
the Infinity CentralStation speaker volume
setting and all speaker connections.
Instructions for Use Infinity CentralStation SW VF8
25