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MOVES SLC
Thornhill Medical MOVES SLC User Manual
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Part Number: 12482
6
Rev. J
20
April 2020
Caution: Federal law restricts this device to sale by or on the order of a physician.
© 2016 Thornhill Rese
arch Inc. All R
ights Reserved
Operator’s Manual
2
Table of Contents
Table of Contents
3
Notices
15
Contact Information
15
Manufacturer
15
Notified Body
15
Authorized Representatives
15
Patent Notice
15
Copyright Notice
15
Trademark Notices
16
EMC (Electromagnetic Compatibility) Notice
16
MRI (Magnetic Resonance Imaging) Notice
16
Phthalates Notice
16
Regulatory Notice
16
Classification
16
Declaration of Conformity Notice
17
Trade Name
17
Figure 9-4: MOVES
17
Figure 10-2: MOVES
17
MOVES ® SLC™ Quick Start Guide for Ventilated Patients
19
System Test Instructions
24
Figure 2-1: Battery Verify Test Screen
30
Further Information on Procedures
31
Table 1: Quick Reference to Information on Procedures
31
Introduction
35
General Information
35
Manufacturer's Information
35
Glossary of Terms and Abbreviations
35
Table 2: Glossary of Terms and Abbreviations
35
MOVES ® SLC™ Intended Use
37
Operating Environment
38
Target Population
38
Intended Operator
38
Regulatory Compliance
39
Regulatory Symbols
39
Regulatory Standards Compliance
39
Table 3: Regulatory Symbols Used and Description
39
Table 4: Regulatory Standards Compliance
39
MOVES SLC™ System Overview
41
General Overview
41
System Orientation and External Components
41
Theory of Operation
42
Breathing Circuit and Oxygen Supplement
42
Figure 5-1: MOVES SLC™ Upright System Orientation and Components
42
Oxygen Concentrator
43
Ventilator
43
Respiratory Gas Monitoring
43
Suction
45
Patient Monitoring
45
Power System
46
System Auto Resume on Power Loss
47
Safety Information
49
Manual Symbols and Messages
49
Notes, Cautions and Warnings
49
Table 5: Symbols and Messages Used in Manual
49
Operational Symbols
50
Label Warning Symbols
50
Product Labels Symbols
50
Table 6: Operational Symbols and Descriptions
50
Table 7: Label Warning Symbols and Descriptions
50
Table 8: Product Label Symbols and Descriptions
50
General Warnings
53
Table 9: General Warnings
53
Electrical Warnings
55
Table 10: Electrical Warnings
55
Patient-Specific Warnings
57
Table 11: Patient-Specific Warnings
57
Masimo Rainbow SET Pulse CO-Oximeter Warnings
59
Table 12: Masimo Rainbow SET
59
General Cautions
63
Table 13: General Cautions
63
Electrical Cautions
66
Patient-Specific Cautions
66
General Safety
66
Table 14: Electrical Cautions
66
Table 15: Patient-Specific Cautions
66
Electrical Safety
68
Preparing for Emergency Operation
68
Radio Interference
69
Battery Handling
69
Battery Disposal
69
Essential Performance
69
Oxygen Concentrator
69
Suction
70
80601-2-12 (General Ventilation)
70
80601-2-13 (Anesthetic Ventilation)
70
The Masimo Rainbow SET Pulse CO-Oximeter
73
No Implied License
73
Overview
73
Key Features
73
Indications for Use
73
Pulse Oximeter Technology Overview
74
Signal Extraction Technology (SET ® )
74
General Description for Oxygen Saturation (Spo )
74
Successful Monitoring for Spo , PR, and PI
74
Functional Oxygen Saturation
74
General Description for Pulse Rate (PR)
74
General Description for Perfusion Index (PI)
74
General Description for Pleth Variability Index (PVI)
75
Rainbow Pulse CO-Oximetry Technology
75
Figure 7-1: Absorption Spectra of Blood Components
75
Pulse CO-Oximetry Vs. Drawn Whole Blood Measurements
76
General Description for Total Hemoglobin (Sphb)
76
Figure 7-2: Leds and Detector
76
Successful Monitoring for Sphb
77
General Description for Spoc
77
General Description for Carboxyhemoglobin (Spco)
77
Successful Monitoring for Spco
77
General Description for Methemoglobin (Spmet)
77
Successful Monitoring for Spmet
77
Spco, Spmet, and Sphb Measurements During Patient Motion
78
Troubleshooting the Masimo Pulse Oximeter
79
Troubleshooting Measurements
79
Low Measurement Confidence
79
Low Perfusion
79
Low Signal Quality
79
Spo2 Values Do Not Correlate with Clinical Assessment or Arterial Blood Gas Measurements
80
Unexpected Spo2, Spco, Spmet, or Sphb Reading
80
Unexpectedly High Spco Reading
80
Difficulty Obtaining a Reading
80
Spco Reading Displays as Dashes
80
Getting Started
81
Moves Slc™ Accessories & Remote Screen Warnings and Cautions
81
Table 16: MOVES SLC™ Accessories Warnings and Cautions
81
MOVES ® SLC™ System Contents
82
MOVES ® SLC™ System Components
82
Table 17: MOVES
87
Table 18: MOVES
88
Table 19: MOVES
88
MOVES SLC™ Re-Usable Consumables
95
MOVES SLC™ Single Patient Use Consumables
98
MOVES SLC™ Standard System Contents
101
Lifting the MOVES SLC
102
Slc
103
Figure 9-2: Lifting Slot
104
Figure 9-3: Lifting Arch
104
Attaching the Shoulder Strap to MOVES
105
Slc
105
Attaching Clamps to the MOVES SLC
108
Attaching Clamps to Top Mount MOVES SLC
109
Attaching Clamps to Side Mount MOVES SLC
112
Using the MOVES ® SLC™ Stretcher Adapter Bar
118
Patient Monitoring Accessories
121
Table 20: Patient Connector Labels and Accessories
121
Figure 9-5 : Patient Connection Panel
121
Installing the Ventilator Cartridge and Breathing Circuit
122
About the Ventilator Cartridge
122
Figure 9-6: Ventilator Cartridge
123
Installing the Ventilator Cartridge
124
Installing the Hydrocarbon Filter
127
Installing the Ventilator Breathing Circuit
128
Figure 9-7: Ventilator Breathing Circuit
128
Delivering Supplementary Oxygen (O2)
132
Using an External Gas Supply
137
Installing Suction Accessories
139
Installing an IV Pole
143
Using an Optional Humidifier
144
Preparing MOVES SLC™ for Use
145
Checking the Charge
145
Figure 9-8: Battery with Condition Indicator Shown
145
Inspecting the Batteries
146
Figure 9-9: Condition Indicator Showing High Level Charge
146
Checking for Battery Installation
147
Figure 9-10: Visible Yellow Handle Indicates Battery Present
147
Installing the Batteries
148
Preparing the Power Supply / Battery Charger
151
Connecting MOVES SLC™ to the Power Supply / Battery Charger
152
Connecting AC Power
153
Battery Storage
153
Figure 9-11: Battery Disconnected (Compartment Open)
154
Figure 9-12: Battery Removed
154
10.0 Startup
155
Adjusting the Screen Display Orientation
155
User Interface (UI) Controls and Functions
157
Table 21: User Interface Controls and Functions
157
Figure 10-1: Flip Button
157
System Visual Indicators (Alarms / System Status)
160
Table 22: System Visual Indicator States and Explanations
160
Changing Settings and Data Views
161
Display of Settings and Views
162
Modifying a Setting
162
Confirming Display Validity
162
Table 23: Screen Buttons and Descriptions
162
Startup Sequence
163
Figure 10-3: Power Control Button
163
Figure 10-4: New Patient Screen
163
Figure 10-5: New Patient Screen - Restore Settings Unavailable
164
Figure 10-6: System Test Screen
165
Figure 10-7: Setup Screen
166
Moves Slc Tm
169
Status Bar
169
Table 24: MOVES
169
Figure 11-1: Status Bar
169
Battery Status Icon
171
Table 25: Battery Status Icon Table
172
System Test Screen
173
Figure 11-2: System Test Screen
173
Setup Screen
174
Overview
174
Figure 11-3: Configure for a New Patient Screen
174
Changing Settings
175
Setup Screen - Ventilate Mode
175
Setup Screen - O2 Supplement
175
Figure 11-4: Setup Screen - Ventilate Mode
175
Figure 11-5: Setup Screen - no Capnography Warning
176
Figure 11-6: Setup Screen - O2 Supplement
176
Setup Screen - Monitor Only
177
Setup Screen Options
177
Table 26: Setup Screen Options and Descriptions
177
Figure 11-7: Setup Screen - Monitor Only
177
Advanced Screen
180
Accessing the Advanced Screen
180
Figure 11-8: Accessing the Advanced Screen
181
The Advanced Screen
182
Table 27: Advanced Screen Options
182
Figure 11-9: the Advanced Screen
182
Spo2 Average Time
183
Spo2 Sensitivity Modes
183
Spo2 Alarm Delay
183
Spo2 Alarm Rapid Desat
183
PVI Display
184
PVI Average Mode
184
Sphb Arterial/Venous Mode
184
Sphb Average Mode
184
ECG EMG Filter
184
Line Filter
184
Masimo Supported Parameters
184
Info Screen
184
Accessing the Info Screen
184
Figure 11-10: Accessing the Info Screen
185
The Info Screen
186
Information Located on the Info Screen
186
Table 28: Info Screen Items
186
Figure 11-11: the Info Screen
186
Main Screen
187
Figure 11-12: Screen Items Drawn in Reverse
188
Figure 11-13: Screen Items Displaying Dashes
188
Figure 11-14: Screen Items Displaying the Fault Icon
188
Selection Order for Options
189
Figure 11-15: Main Screen with Dashes & Alarms
189
Main Screen Items
190
Table 29: Main Screen Items and Descriptions
190
Figure 11-16: ECG & IP Graph Options & Sub-Options
190
Additional Items Displayed with Masimo Sensors
196
Figure 11-17: Values Obtained Via Masimo DC-3 Sensor
196
Control Pressure, PEEP and PIP
197
Figure 11-18: Values Obtained Via Masimo DCI-Dc3 Sensor
197
Figure 11-19: Control Pressure & PEEP on Setup Screen
197
Figure 11-20: PIP & PEEP on Main Screen
197
Actual PEEP Higher than Set PEEP
198
Inverted Display of Patient Monitoring Values
198
Figure 11-21: Relations of PEEP to PIP to Control Pressure
198
Invasive Pressure (IP) Source Buttons
199
Zeroing a Channel
199
ECG Screen
199
Overview
199
Figure 11-22: Regular Temperature Display
199
Figure 11-23: Inverted Display of Temperature (Alarm Condition)
199
Figure 11-24: ECG Screen - Normal Mode
200
Figure 11-25: ECG Screen - Graphs Paused
200
Alarm Limits Screen
201
Overview
201
Limit List Active
201
Figure 11-26: Alarm Limits Screen - All at Default
201
Table 30: Alarm Limits and Defaults
202
Figure 11-27: Alarm Limits Screen Active
202
Alarm on / off Screen
204
Overview
204
Figure 11-28: Alarm on / off Screen
204
Alarm On/Off List Active
205
Figure 11-29: Alarm on / off Screen Active
205
12.0 Using the Remote Screen
207
Overview
207
Figure 12-1: MOVES
207
Replacing / Installing the Remote Screen Battery
208
Connecting the Remote Screen to Wall Power
213
Remote Screen Indicators
215
Figure 12-2: Remote Screen Indicators
215
Remote Screen Battery Status
216
Table 31: Remote Screen Indicators
216
Slc
217
Activating the Wired Connection
221
The Remote Screen User Interface (UI)
222
First Connecting
222
Figure 12-3: Initial Screen - Resources Loading
222
The Dashboard
223
Figure 12-4: Main Remote Screen - Connecting and Resources Loaded
223
Figure 12-5: the Status Bar
224
No System Test Screen
225
Figure 12-6: Remote Screen Alarm Audio Options
225
Figure 12-7: Alarm Volume Locked at Maximum
225
Figure 12-8: Setup Screen - Initializing
226
Figure 12-9: Setup Screen - Monitor Only Mode
227
Remote Screen Panel Buttons
228
Figure 12-10: Main Screen - on Remote Screen
228
Figure 12-11: Remote Screen - Panel Buttons at Bottom
228
Graphs Independently Configurable
229
Alarm Indicators
229
Table 32: Buttons on the Remote Screen
229
Table 33: Alarm Side Bar States and Explanations
230
Figure 12-12: Green Bars Indicating no Alarms Active
230
Figure 12-13: Red Bars Indicating High-Priority Alarm Active
231
Figure 12-14: Yellow Bars Indicating Low or Medium Priority Alarm Active
231
Remote Screen Software Version
232
Figure 12-15: Info Screen Showing Remote Screen Version
232
13.0 Connecting the Patient
233
Connection Overview
233
Connecting an Intubated Patient
233
Connecting a Spontaneously Breathing Patient
233
Attaching the Ear or Finger Clip Pulse CO-Oximeter Sensor
234
Table 34: CO-Oximeter Sensors
234
Figure 13-1: 1 of 5 Possible Sensor Finger Placements
236
Figure 13-2: Correct Ear Lobe Sensor Placement
236
Placement of the Heart Rate Electrodes
237
ECG Cable Color Coding and Naming Conventions
237
Figure 13-3: Color-Coded 12-Lead ECG Cable
237
Correct Electrode Placement
238
Table 35: ECG Cable Color Coding and Naming
238
Reducing Artifacts
239
Expiry Date of ECG Electrodes
239
Table 36: Proper Placement of Precordial Leads
239
Figure 13-4: Proper Limb Lead Electrode Placement
239
Figure 13-5: Precordial Leads: V1-V6
239
Zeroing the Pressure in the IP Transducer
240
Zeroing the Transducer Channel
240
Figure 13-6: Electrode Package
240
Figure 13-7: Electrode Use by Date
240
Figure 13-8: Transducer Stopcock in Running Position (Horizontal)
240
Figure 13-9: Transducer Stopcock in Open-To-Ambient-Air Position (Vertical) Zero Transducer
240
Transducer Warnings
241
Using the Suction Feature
241
Figure 13-10: Suction Wand Showing Control Vent
241
Shutdown Procedures
242
14.0 Using System Graphs / Trends
245
Overview
245
Figure 14-1: Plotting Graphs on Main Screen
245
Available System Graphs / Trends
246
System Graphs
246
Table 37: System Graphs and Parameters
246
System Trends
248
Table 38: System Trends and Parameters
249
15.0 Alarms
251
About Status Leds
251
Alarm Priorities and Characteristics
251
Standard Alarms
251
Table 39: Alarm Types and Descriptions
251
High Priority Communication Failure Alarm
252
Alarm Queue
252
Figure 15-1: no Alarms Message in Alarm Queue
252
Locked Alarms and Messages
253
Inhibitable and Latching Alarms
253
Inhibitable Alarms
253
Figure 15-2: Two Locked Alarms
253
Figure 15-3: Inhibitable Alarm Able to be Dismissed
253
Figure 15-4: Inhibitable Alarm Cleared
253
Latching Alarms
254
Alarms that Have Been Turned off
254
Figure 15-5: Latched Alarm Able to be Dismissed
254
Figure 15-6: Latched Alarm Cleared
254
Figure 15-7: Latched Alarm Able to be Dismissed
254
Auto Restoration of Alarm Settings Upon Power Loss
255
Testing Alarms
255
Testing Adjustable Alarms
255
Table 40: Adjustable Alarms, Test Procedures and Results
255
Testing Non-Adjustable Alarms
258
Table 41: Non-Adjustable Alarms, Test Procedures and Results
258
Alarm Conditions and Causes
260
Table 42: Alarm Conditions and Causes
260
System Test Failure Messages and Causes
303
Table 43: System Test Failure Messages and Causes
303
Safe Gas Mode
306
Figure 15-8: Status Bar Showing System in Safe Gas Mode
307
System Default Settings
309
Table 44: System Default Settings
309
System Cleaning
311
System Maintenance
312
User Serviceable Components
313
Replacing the Ventilator Filter
313
Replacing the Hydrocarbon Filter
315
Replacing the Ventilator Liner
317
Exercising the Oxygen Concentrator
320
Battery Charging
320
Other Maintenance / Repair Items
320
End of Life
320
Accessories Maintenance
321
Checking the Accuracy of the Temperature Probe
321
MOVES ® SLC™ Specifications
321
Model Number
321
Physical Properties
321
Table 45: Physical Properties of MOVES ® SLC
321
Oxygen Concentrator Specifications
323
Table 46: Oxygen Concentrator Specifications of MOVES
323
Table 47: Oxygen Concentrator Specifications of MOVES
323
Ventilator Specifications and Vent Mode Definitions
324
Table 48: Ventilator Specifications of MOVES ® SLC
326
Suction Specifications
328
Electrical Characteristics
328
Table 49: Suction Specifications of MOVES ® SLC
328
Table 50: Electrical Specifications of MOVES ® SLC
328
Environmental Specifications
329
Table 51: Environmental Specifications of MOVES ® SLC
329
Patient Monitoring Specifications
331
Heart Rate Monitoring Specifications
331
Table 52: Environmental Specifications of the Remote Screen
331
Table 53: Heart Rate Monitoring Specifications of MOVES ® SLC
331
Temperature Monitoring Specifications
332
Airflow Monitoring Specifications
332
Table 54: Temperature Monitoring Specifications of MOVES ® SLC
332
Table 55: Airflow Monitoring Specifications of MOVES ® SLC
332
CO 2 Monitoring Specifications
333
Respiratory Rate Monitoring Specifications
333
Table 56: CO 2 Monitoring Specifications of MOVES ® SLC
333
Table 57: Respiratory Rate Specifications of MOVES ® SLC
333
O 2 Monitoring Specifications
334
ECG Specifications
334
Table 58: O 2 Monitoring Specifications of MOVES ® SLC
334
Table 59: 12-Lead ECG Specifications of MOVES ® SLC
334
Table 60: 3-Lead ECG Specifications of MOVES ® SLC
335
NIBP Specifications
337
Invasive Pressure Specifications
337
Table 61: NIBP Specifications of MOVES ® SLC
337
Table 62: Invasive Pressure Specifications of MOVES ® SLC
337
Pulse Oximetry Specifications
338
Table 63: Pulse Oximetry Specifications of MOVES ® SLC
338
Equipment Response Time
339
Drift in Sensing Accuracy
339
Specifications of Masimo Rainbow SET
339
Pulse CO-Oximeter
339
Table 64: Pulse Oximetry Equipment Response Time
339
General Accessories Specifications
342
Approved Masimo Pulse Oximeter Accessories
342
Table 65: General Accessories Specifications of MOVES ® SLC
342
Table 66: Approved Masimo Pulse Oximeter Accessories
342
Masimo Pulse Oximeter Accessories Specifications
344
Table 67: Masimo Pulse Oximeter Accessories Specifications
344
Electromagnetic Conformity Information
347
IEC 60601-1-2:2014 (Ed 4.0) Table 1 Requirements
347
Table 68: 5.2.2.1C IEC 60601-1-2:2014 (Ed 4.0) Table 1 Requirements
347
IEC 60601-1-2:2014 (Ed 4.0) Table 2 Requirements
348
Table 69: 5.2.2.1F IEC 60601-1-2:2014 (Ed 4.0) Table 2 Requirements
348
IEC 60601-1-2:2014 (Ed 4.0) Table 3 Requirements
349
Table 70
349
IEC 60601-1-2:2014 (Ed 4.0) Table 5 Requirements
351
17.0 Appendix B - Pneumatic Diagram
353
Moves
353
18.0 Appendix C - End-User License Agreement
355
19.0 Index
357
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Thornhill Medical MOVES SLC Specifications
General
Brand
Thornhill Medical
Model
MOVES SLC
Category
Medical Equipment
Language
English
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