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MAC 5 A4
GE MAC 5 A4 User Manual
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Regulatory and Safety Information
Table 146: Serial Number Label F
ormat
Item
Description
1
Pr
oduct Par
t Number
2
Pr
oduct Mode
3
Date of Manufactur
e in YYYY-MM-DD Format
4
Device Serial Number
5
UDI Bar
code
Device Address Label and Rating Plate
The device address label and rating plate is in the format as follows:
5864335-001-1

MAC
â„¢
5 A4/MAC
â„¢
5 A5/MAC
â„¢
5 Lite

365
364
366
Table of Contents
Publication Information
2
Table of Contents
4
1: Product Overview
10
Front View
10
Side and Rear View
11
Acquisition Screen Overview
12
User Menu Options Description
16
Battery Status
18
Show Battery Status
19
Show Network Connection Status
20
Change the Brightness of the Screen
21
2: Equipment Setup
22
Insert the Battery
22
Connect the AC Power
23
Connect the External Barcode Reader
24
Adjust the Device for Paper Size
27
Insert the Paper
32
Lock and Unlock the Trolley Wheels
35
Attach the Device to the Trolley
36
Connect the LAN Cable
37
Configure the Device
38
Test the Device
38
3: Login and Security
39
Power on the ECG Device
39
Power off the ECG Device
39
User Authentication
40
Log on to the Device
41
Log on the Device as a STAT User
43
Access the Device Using a Technician ID
43
Log out of the Device
43
Change the User Password
44
Activate or Deactivate Privacy Mode
44
Lock the Device
45
Unlock the Device
45
Put the Device on Standby
46
Perform System Reset
46
4: Patient Information
48
Patient Information Screen Overview
48
Start a Test for a New Patient
51
Enter Patient Information
51
Update Patient Information with a Barcode Reader
52
Query Orders or ADT for Patient Demographics
53
Enter or Edit Patient Information Using the Software Keyboard
59
Enter or Edit Clinical Trial
60
5: Record an ECG or Rhythm
62
Hookup Advisor Overview
62
Acquire an ECG Based on the Hookup Advisor Status in Post-Acquisition Mode
65
Acquire an ECG Based on the Hookup Advisor Status in Pre-Acquisition Mode
65
Change Lead Sets and Lead Formats
65
Enable ACS Interpretation
66
Enable HD Pace
67
Change Speed, Gain, and Filter
68
ECG Acquisition Overview
69
Automatically Acquire an ECG
69
Manually Start an ECG Recording
70
Cancel an ECG
72
Accept or Reject an ECG Patient Report
72
Review an ECG Patient Report
76
Automatically Print an ECG Patient Report
78
Record a Rhythm
79
Review a Digital Rhythm Report
80
Transmit a Patient Report to a Configured Destination
82
Print a Patient Report
85
Edit Patient Information in a Patient Report
87
Delete a Patient Report
87
View the Patient Report
88
Close a Patient Report
88
Full Disclosure Overview
89
Record a Full Disclosure ECG
90
Review a Full Disclosure Report
91
6: Work with Orders
94
Automatically Update the Orders List
97
Manually Update the Orders List
97
Sort Orders in the Orders List
98
Filter Orders in the Orders List
98
Attach an Order When the Patient Test Is Not Started
101
Attach an Order to a New Patient Test
101
Attach an Order When the Patient Test Is Completed
102
Attach an Order that Is Attached to a Different Patient Test
103
Change the Order Attached to a Patient Test
104
Detach an Order from a Patient Test
104
Order Status
105
7: Work with the Files List
107
Review a Stored Patient Report
109
Transmit a Stored Patient Report to a Configured Destination
111
Print a Stored Patient Report
114
Print a List of Stored Records
115
Edit Patient Information in a Stored Patient Report
116
Delete Stored Patient Reports from the Files List
117
8: Work with the Queue List
119
Display the Report Queue
121
Delete Jobs from the Queue
122
Retry Transmission of a Patient Report
122
9: Work with the Patients List
124
Open the Patients List
126
Select a Patient from the Patients List
126
10: Configure Settings
127
Settings Screen Overview
127
Open the Settings Screen
128
Configure General Tasks
128
Configure ECG
129
Configure ECG Acquisition
129
Configure Filters, Gain, and Speed
132
Configure 12SL Interpretations
135
Configure Display Formats of ECG and Rhythm Leads
137
Configure Patient Reports
140
Configure Lead Sets
145
Configure Rhythm
148
Configure Critical Value Notifications
149
Configure Full Disclosure
151
Configure Patient Data
152
Configure Patient Information
152
Configure Clinical Trial
159
Configure Workflow
163
Configure Transmission Settings
164
Configure Network Printer
183
Configure Order Management
186
Patient Query Overview
198
Configure Remote Patient Query
199
User Account
200
Configure Security
201
Types of User Roles
206
Types of User Profiles
207
Configure User Roles
209
Configure User Profiles
213
Configure LDAP
216
Configure Network
226
Configure Shared Network Settings
227
Configure Device Host Name
228
Configure Wired Network
229
Configure Wireless Network
231
Configure Wireless Country of Operation
238
Install Wireless Certificates
239
Intermediate Certificates
242
Configure Proxy Settings
243
Show Network Connection Status
244
Configure System
246
Configure Device Parameters
246
Configure External Storage
247
Save and Restore Configuration Settings
248
Save and Restore User Settings
250
Restore to Factory Defaults
252
Configure Log Server
253
Delete TLS Encryption Certificate
255
Configure the Clock and Language
255
Configure the Date and Time
255
Configure NTP
258
Configure Region
259
Configure Hardware
260
Configure the Barcode
260
Configure the USB Ports
261
Configure Keyboard Tone and KISS Pump
261
Configure Standby Modes
262
11: Maintenance
265
Store Thermal Paper
265
Clean the Printhead
266
Charge the Battery
266
Replace the Battery
267
12: Cleaning and Disinfection
269
Inspect the Device
269
Care at the Point of Use
269
Preparation for Cleaning
269
Clean and Disinfect Guidelines
269
Visual Inspection, Cleaning and Disinfection Frequency
270
Clean and Disinfect the Device and Trolley
271
Pre-Clean Inspection and Functional Test
271
Clean the Device and Trolley
271
Post-Clean Inspection
272
Disinfect the Device and Trolley
272
Clean and Disinfect Leadwires and Reusable Electrodes
273
Storage
273
Other Cleaning and Disinfection Agents
273
Additional Information
274
13: Troubleshooting
275
System Errors
275
ECG Acquisition Errors
276
Printing Errors
277
Report Transmission Errors
280
Configuration File Errors
282
USB Flash Drive Errors
282
Shared Network Connection Errors
283
Errors While Installing Certificates
283
Wireless Network Connectivity Errors
284
LDAP Configuration Errors
286
A: Report Formats
287
ECG Report Formats
287
Rhythm Report Format
291
Full Disclosure (FD) Report Format
294
B: Patient Preparation
298
Prepare the Patient's Skin
298
Electrode Placement
299
Standard 12-Lead Electrode Placement
299
C: Patient Data Fields
301
Patient Information Text Box Names
301
Clinical Trial Text Box Names
310
D: Configure the MUSE System for Network Communication
312
MUSEAPI3 Installation
312
Before You Start
312
Install MUSEAPI3 on MUSE V8 Server
313
Install MUSEAPI3 on MUSE V9 Server
319
Change the MUSEAPI3 Service Protocol Configuration
323
Uninstall MUSEAPI3
324
Restore the MUSEAPI3 Configuration
325
MUSEAPI Test Client
325
Obtain the Thumbprint of the SSL Certificate for the MUSEAPI3 Port
326
Set up DCP Inbound Communication for MUSE V8.X or V9.X
328
Add the DCP Service and DCP Communication Option to the MUSE System
328
Set up the DCP Server Configuration in the MUSE System
329
E: Configure the Cardiosoft System for Network Communication
331
Cardiosoft V7 Installation
331
Set up DCP Port in Cardiosoft V7.0
331
F: System Checkout
332
DCP Transmission to the MUSE System
332
DCP Transmission to the Cardiosoft System
332
MUSE Order Download
332
G: Technical Specifications
333
System Specifications
333
ECG Specifications
335
Environmental Specifications
336
Safety Specifications
337
Network Specifications
338
H: Regulatory and Safety Information
339
Intended Use
339
Indications for Use
339
Contraindications
340
Clinical Benefits
340
Prescription Device Statement
340
Safety Conventions
340
Safety Hazards
341
Classification of Medical Device
344
Certification Information
345
Recording Ecgs During Defibrillation
345
Modulating Effects in Digital Systems
346
Electromagnetic Compatibility (EMC)
346
Guidance and Manufacturer's Declaration-Electromagnetic Emissions
347
Guidance and Manufacturer's Declaration-Electromagnetic Immunity
347
Essential Performance
348
Biocompatibility
349
Legal Notice
349
Supplies and Accessories
350
Responsibility of the Manufacturer
350
Responsibility of the Purchaser/Customer
350
Notification to Member States
350
Warranty Information
350
Product and Packaging Information
351
MAC 5 A4 Hardware Label Locations
351
MAC 5 A5 Hardware Label Locations
355
MAC 5 Lite Hardware Label Locations
360
Serial Number Label
364
Device Address Label and Rating Plate
365
Symbol Descriptions
366
Serial Number Format
370
Unique Device Identifier
371
Wireless Regulations
371
FCC Compliance
372
IC Compliance
372
RED Information
373
Declaration of Conformity
373
Glossary
374
4
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GE MAC 5 A4 Specifications
General
Brand
GE
Model
MAC 5 A4
Category
Measuring Instruments
Language
English
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