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Infinity M300 series
Page 263 (Disposal)
Dräger Infinity M300 series - Disposal
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Instructions for
use – Infini
ty
®
M300 and M300+ series – VG3.0
263
Disposal
Disposal
Disposal of the medical d
evice
. . . . . . . . . . .
264
M300/M300
+, Bedsid
e Charge
r
, and
Central Charger
. . . . . . . . . . . .
. . . . . .
. . . . .
264
262
264
Table of Contents
Main Page
For Your Safety and that of Your Patients
7
Trademarks
4
Trademarks Owned by Third-Party Manufacturers
4
Trademarks Owned by Dräger
4
Open-Source Software
5
Safety Information Definitions
5
User Group Requirements
5
Duties of the Operating Organization
5
User Groups
6
Abbreviations and Symbols
6
Product Compatibility Information
6
Table of Contents
7
Training
8
Unauthorized Changes to Hardware or Software
8
Strictly Follow These Instructions for Use
8
Storing the Instructions for Use
8
Mandatory Reporting of Adverse Events
8
Maintenance
9
Accessories
9
Installing Accessories
10
Sterile Accessories
10
Environment of Use
10
Restrictions for Use
10
Restriction of Distribution
10
Devices
11
Connection to Hospital Network
11
Networking and Connection to Other Devices
11
Connected Devices
11
Connection to Other Devices
12
Safe Connection with Other Electrical
12
Equipment
12
Electrical Safety
12
Patient Safety
13
Patient Monitoring
13
General Safety Information
13
Not for Use in Areas of Explosion Hazard
15
Information on Electromagnetic Compatibility
15
Site of Operation
16
Defibrillator Precautions
17
Cybersecurity
19
Definition of Cybersecurity Terminology
20
Cybersecurity Safety Information
21
Cybersecurity Information and Recommendations
23
Recommendations
23
Passwords
25
Cybersecurity Incident Response
26
Product Security Information
26
Infinity Network Configuration
27
Security Modes of Operation
28
Conditions
29
Network Security Troubleshooting and Error Conditions
29
M300/M300+ Network Error Message
31
PSK Security Credential Expiration
31
Network Support Matrix
32
Table of Contents
33
Indications for Use
39
Contraindications
40
Indications for Use
40
System Overview
41
M300/M300
42
Overview of the ICS Relative to M300/M300
42
Infinity M300
43
Overview of the M300/M300
43
Infinity M300/M300+ Communications
44
Infinity M300/M300+ User Interfaces and Functions
44
Battery Status LED of the M300
45
Front Panel of the M300
45
Critical Battery Alarm
46
Low Battery Alarm
46
Power-Save Mode
46
Keys of the M300
47
Back Panel of the M300
48
Avoiding Charger and Adapter Damage
49
Overview of the Bedside Charger
49
M300 Screen Examples
50
Power On/Off
50
Overview of the Central Charger
51
Infinity M300
52
M300+ Front of the Device
52
M300+ Swappable Battery
53
Battery Safety Information
54
Swappable Battery Run Time on the M300
54
Battery
55
Caring for the M300+ Lithium-Ion Swappable Battery
55
Preventive Maintenance
55
Charge Status for Swappable Battery Attached to the M300
56
To Check the Charge Status on the Swappable Battery
56
To Insert the Swappable Battery into the M300
58
M300+ Battery Charging Station for Swappable Batteries
59
Inserting the Swappable Battery into the Charger
60
Removing the Swappable Battery from the Charger
60
Device Symbols
61
Abbreviations
66
Operating Concept
69
M300
70
M300 Terminology
70
Overview of M300 Operating Concept
70
ICS Components
71
Telemetry Monitoring
72
Ics
73
M300 Power
73
Volume Control
73
Minimum Alarm Volume
74
Communicating with the Infinity Network
75
Offline Condition Notification
75
Local ICS
76
M300
76
Remote ICS
76
Communication Management
77
Moving an M300/Patient from One Room (Viewport) to a Different Room (Viewport)
78
Supported Symbols
79
Electronic Patient Data Transfer
81
Transferring Patient Data
82
ICS and M300 Online Help
84
Standby Mode
85
Standby/ Discharge Page
86
Canceling Standby Mode
87
Enabling Standby Mode
87
M300 User Interface
89
M300 Header Bar
90
M300 Keypad
91
M300 Waveforms
91
Charging the M300 Battery
93
Battery Status LED
94
Overview
94
Using the Bedside Charger
95
Using the Central Charger
97
Getting Started
101
Overview of Monitoring a Patient
102
Turning the M300 On/Off
102
(Bedview in ICS)
103
Telemetry/Parameters Dialog Window
103
The Layout/ Parameters Page (in ICS)
103
M300 Demographics Screen
105
Admitting a Patient
106
Admitting a New M300 Patient
107
Admitting a Patient at the ICS
108
Admitting under Special Circumstances
108
Populating Patient Data over the Network
109
Discharging a Patient
110
Discharging an M300 Patient
110
Discharging an M300+ Patient
111
Patient Categories
112
Selecting a Different Patient Category
112
Alarms
115
Overview of Alarms
116
Alarm Priorities
117
Alarm Processing
117
High-Priority Alarm Conditions
117
ICS General Alarm Processing
117
Low-Priority Alarm Conditions
117
Medium-Priority Alarm Conditions
117
M300 Alarm Processing
118
Parameter Box Flashing Rate
119
Latching and Non-Latching Alarm
120
Activating or Deactivating Alarm Validation
121
Alarm Validation Times for the M300
121
Alarm Signals
122
ICS and M300 Audio Alarm Signals
122
Visual Alarm Indicators on the M300
122
M300 Speaker Alarm Tones
123
Adjusting the M300 Alarm Volume
124
Pausing Audio Alarms for the M300
125
Pausing Alarms for the M300
126
Pausing Audio Alarms for the M300 from a Remote Network Device
126
Alarm Setup for Multiple Parameters
127
Pausing Alarms for the M300 from a Remote Network Device
127
Configuring Alarm Settings for Multiple
128
Parameters
128
Alarm Setup for Arrhythmia Parameters
130
Configuring Arrhythmia Alarm Settings
131
Auto Setting All Alarm Limits
132
Recordings
132
Special Conditions for Alarm Event Recordings
132
Alarm Groups
133
Special Conditions for Alarm Event Storage
133
Storage
133
Defaults
134
M300 Alarm Ranges and Defaults
134
Parameter Ranges and Defaults
134
Arrhythmia Parameter Ranges and Defaults
135
Ecg, Arrhythmia, and St Segment Monitoring with M300
137
Monitoring with M300
137
ECG Signal Processing and Display
138
ECG, Arrhythmia, and ST Segment Monitoring with M300
138
Overview of Telemetry Defaults
138
Patient Preparation for ECG Monitoring
139
Supported Parameters
139
ECG Display
140
ECG Parameter Box in a Viewport of the ICS Main Screen
140
ECG Precautions
140
ECG Parameter Box in the ICS Bedview
141
ECG Parameter Box on the M300
141
ECG Waveform in a Viewport of the ICS Main Screen
141
ECG Waveform on a Bedview Page of the ICS
142
ECG Waveform on the M300
142
Ics
142
ECG Electrode Colors
143
Electrode Placement
144
Standard Configuration, Three Electrodes (IEC/AHA)
144
(Iec/Aha)
145
Standard Configuration, Five Electrodes
145
(Iec/Aha)
146
Pacer Configuration, Five Electrodes
146
(Iec/Aha)
147
Accessing the ECG Setup Page
147
ECG Parameter Setup Functions
148
Monitoring Paced Patients
149
Pacemaker Considerations
149
Pacemaker Precautions
149
Device Interference with Pacemaker
151
Monitoring
151
Pacer Fusion Mode
151
Overview of Arrhythmia Monitoring
152
M300/M300+ Arrhythmia Processing
153
Selecting Arrhythmia Leads
154
Arrhythmia Modes
157
Notifications
157
Recommended Remedies for Lead-Off
157
Arrhythmia Display
158
Arrhythmia Parameter Box on an ICS Bedview
158
Accessing the Arrhythmia Setup Page
159
Arrhythmia Parameter Setup Function
159
Overview of ST Monitoring
159
Connecting Lead Wire Sets for ST Monitoring
161
Monitoring
161
Standard ST Monitoring
161
12-Lead Trust Monitoring
162
ST Complex Pages
163
ST Display
163
ST Parameter Box on an ICS Bedview
163
Viewing All ST Complexes
164
Zooming in on an ST Complex
166
Adjusting ST Measuring and ISO Points
167
ST Measuring and ISO Points
167
Accessing the ST Setup Page
168
Saving ST Reference
168
ST Reference
168
Learning/Relearning QRS Pattern
169
ST Parameter Setup Functions
169
Spo and Pulse Rate Monitoring with Masimo and M3002
171
Masimo and M300
171
Masimo
172
Monitoring with Masimo
172
Spo and Pulse Rate Monitoring with Masimo and M300
172
Supported Parameters
172
Spo 2 Precautions
173
Starting Spo 2 Monitoring on a Patient
174
Cable to the M300
175
Connecting the Spo
175
Connecting the Spo 2 Cable to the M300
175
Monitoring
175
Patient Preparation for Spo
175
Patient Preparation for Spo 2 Monitoring
175
Applying the Sensor
176
Spo 2 Display
177
Turning Spo 2 Monitoring On/Off
177
Spo 2 Parameter Box in the ICS Bedview
178
Spo 2 Parameter Box on an M300
178
Accessing the Spo2 Page
179
Spo 2 Parameter Setup Functions
179
Spo and Pulse Rate Monitoring with Nellcor and M3002
181
Nellcor and M300
181
Monitoring with Nellcor
182
Overview of Spo 2 Monitoring with Nellcor
182
Spo and Pulse Rate Monitoring with Nellcor and M300
182
Supported Parameters
182
Spo 2 Precautions
183
Starting Spo 2 Monitoring on a Patient
184
Cable to the M300
185
Connecting the Spo
185
Connecting the Spo 2 Cable to the M300
185
Applying the Sensor
186
Monitoring
186
Patient Preparation for Spo Monitoring
186
Turning Spo 2 Monitoring On/Off
187
Spo 2 Display
188
Spo 2 Parameter Box on an ICS Bedview
188
Spo 2 Parameter Box on an M300
189
Accessing the Spo 2 Setup Page
190
Spo Parameter Setup Functions
190
Recordings/Reports
191
Overview
192
R50N Recorder
193
Recorder Setup
193
Initiating Manual Recordings
194
Processing of Strip Recordings
194
Requesting a Remote Recording
194
Setting up a Recording
194
Manual (Timed) Recordings
195
Canceling a Recording
199
Actions that Affect Recordings
200
M300 Offline Recordings
200
System Configuration
201
Biomed > Configure Telemetry Page
202
Overview
202
The Biomed Page
202
Telemetry Default Setup (System Setup)
206
Telemetry Setup (for each M300 Device)
206
Telemetry Setup Defaults
206
General Settings Setup Page
207
The General Settings Page
207
Alarms > Limits Page
209
The Alarms Page (Telemetry)
209
Changing Alarm Limits Settings
211
Alarms > Arrhythmia Page
212
Telemetry Defaults > Alarms > Device Settings Tab
214
Configuring the Alarm Settings of the Patient
215
Patient
215
The Layout/ Parameters Page
215
Layout/ Parameters > Layout Page
216
Layout/ Parameters > ECG Page
221
Layout/ Parameters > Spo2 Page
222
Layout/ Parameters > ST Page
222
The Device Setup Page
226
The Find Device Page
226
Device Setup > Status Page
227
Device Setup > Setup Page
228
Problem Solving
229
Overview of Problem Solving
230
M300 - Arrhythmia Alarm Messages
231
M300 - ECG Alarm Messages
232
M300 - ST Alarm Messages
234
M300 - Spo 2 Alarm Messages
236
M300 Messages
238
Maintenance
241
Overview
242
Definition of Maintenance Concepts
243
Inspection
244
Perform Annual Safety Checks
244
Safety Checks - Infinity M300
244
Preventive Maintenance
245
Reprocessing
247
Classification for Reprocessing
248
Classification of Medical Devices
248
Information on Reprocessing
248
Safety Information
248
Classification of Device-Specific Components
249
Components
249
Before Reprocessing
250
Observe before Disassembly
250
Consumables
251
Device-Specific Components
252
Overview of the Reprocessing Procedures of the Components
253
The Components
253
Validated Reprocessing Procedures
253
Cleaning
254
Surface Disinfection
254
Disinfectants
255
Other Agents and Reprocessing Procedures
255
Procedures
255
Supplementary Information
255
Accessories
257
Categorization of Accessories
257
Reprocessing of Patient-Specific Accessories
257
Reprocessing of the Categories ECG Monolead, Spo2 Intermediate Cable and Spo2
257
Sensor
257
Spo2 Sensor
257
Cleaning
258
Surface Disinfection
258
Other Agents and Reprocessing Procedures
259
Procedures
259
Reprocessing of the Category Pouch
259
Storage and Transport
259
After Reprocessing
260
Components
260
To Insert the Swappable Battery into the M300
260
Checking the Operational Readiness
262
Preparation before Next Use of Device
262
Disposal
263
Charger
264
Disposal of the Medical Device
264
Clause 14.13
265
Technical Specifications
269
Infinity R50N
270
Site of Operation
270
Infinity M300
271
Infinity M300 Bedside Charger (MS29558)
277
Infinity M300
278
Infinity M300 Central Charger (MS25699)
278
Infinity M300+ Battery Charging Station
283
M300/M300+ Performance Data
284
Electromagnetic Compatibility
285
Electromagnetic Compatibility (EMC)
290
Electromagnetic Environment
291
EMC Declaration for M300/M300
291
General Information
291
Operating Characteristics
292
Recommended Separation Distances from Wireless Communication Devices
292
List of Accessories
293
Accessories
294
M300 Accessories Overview
294
General M300 Accessories
295
System Components
295
ECG Monitoring - Reusable Leadsets
296
ECG Monitoring - Single-Patient Use Leadsets
298
Leadsets
298
ECG Monitoring - Monolead
300
ECG Monitoring - Telemetry
302
Connector
303
ECG-Leads Telemetry
303
Telemetry Cables with Single-Pin Connector
303
Masimo
304
Masimo
305
Masimo LNCS Disposable Sensors
305
Masimo LNCS Reusable Sensors
305
Masimo Spo2 Cables
305
Nellcor
306
Dräger Disposable Sensors
307
Dräger Reusable Sensors
307
Nellcor
307
Nellcor Disposable Sensors
307
Nellcor Reusable Sensors
307
Nellcor Spo2 Cables
307
M300+ System Components
308
M300/M300+ Accessories Overview
308
Masimo (for M300/M300+)
308
Index
311
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