User Manuals: St. Jude Medical CardioMEMS CM3000 System

Manuals and User Guides for St. Jude Medical CardioMEMS CM3000 System. We have 3 St. Jude Medical CardioMEMS CM3000 System manuals available for free PDF download: System Manual, User Manual

St.Jude Medical CardioMEMS CM3000 System Manual (72 pages)

HF System

Brand: St.Jude Medical | Category: Medical Equipment | Size: 3 MB

Table of Contents
3
Description
5
Indications
5
Contraindications
5
Warnings
5
Precautions
6
Package Contents
6
Sterilization
7
Components and Setup
7
Patient and Hospital Electronics Systems
9
Antenna
9
Overview
10
- Implant Procedure Overview
  10
New Sensor Implant - Wireless Connection Available
10
- Step 1: Enter Information
  10
- Step 2: Acquire Signal
  12
- Step 3: Set Baseline
  12
- Step 4: Take Reading
  14
- Step 5: Transfer Data
  15
- Step 6: Shutting down the System
  15
New Sensor Implant - no Wireless Connection Available
16
- Step 1: Enter Information
  16
- Step 2: Acquire Signal
  18
- Step 3: Set Baseline
  18
- Step 4: Take Reading
  20
- Step 5: Transfer Data
  21
- Step 6: Shutting down the System
  21
Merlin.net Patient Care Network Heart Failure Management Application Setup
22
Patient Electronics System Setup
22
- Setup - Wireless Connection Available
  23
- Setup - no Wireless Connection Available
  24
Patient Training
26
Overview
27
- Follow-Up Reading Overview
  27
Follow-Up Reading - Wireless Connection Available
27
- Step 1: Retrieve Information
  27
- Step 2: Acquire Signal
  28
- Step 3: Take Reading
  28
- Step 4: Transfer Data
  29
- Step 5: Shutting down the System
  29
Follow-Up Reading - no Wireless Connection Available
29
Locating Sensor Signal
33
- Optimize Signal Strength
  33
- Technically Suspect Readings
  34
- Distance
  34
- Angulation
  35
- Solutions for Interference
  35
Troubleshooting the Patient Electronics System
35
Pulmonary Artery Catheter Setup
36
Manual Setup Instructions
36
- New Sensor Implant
  36
- Patient Electronics System Setup
  38
- Follow-Up
  40
Additional Hospital Electronics System Functions
42
- Wireless Connectivity Setup
  42
- Setting Baseline in Follow-Up Reading
  42
- Settings Screen
  43
- The Admin Screen
  43
- Software Update
  44
Additional Patient Electronics System Functions
44
- Patient Electronics System - Viewing Pressure Values During the Reading
  44
Guidelines for the Management of Hemodynamic Parameters
45
Elevated PA Pressures (Hyper-Volemic)
45
Low PA Pressures (Hypo-Volemic)
46
Recommended Frequency of Cardiomems HF System Review
46
Clinical Study Information
46
- Introduction
  46
- Purpose
  47
- Methods
  47
- Patient Demographics and Disposition
  47
- Primary and Secondary Endpoint Results
  48
- Results from the Entire Randomized Access Period
  49
Cleaning
65
Storage
66
User/Owner Responsibility
66
Electromagnetic Interference and Electromagnetic Compatibility
66
FCC Statement
68
EU REACH SVHC Disclosure
68
WEEE Compliance Statement
68
System Specifications
68
- Electrical Characteristics
  68
- Mechanical Characteristics
  69
- Environmental Information
  69
- Classification
  69
- Testing
  69
- EMI/EMC Testing
  69
- Wireless Testing
  69
Software
69
Technical Support
70
Symbols
70

St. Jude Medical CardioMEMS CM3000 System Manual (36 pages)

Brand: St. Jude Medical | Category: Medical Equipment | Size: 1 MB

Table of Contents
3
Description
5
Indications
5
Contraindications
5
Warnings
5
Precautions
6
Package Contents
6
Sterilization
6
The Patient and Hospital Electronics Systems
7
The Antenna
7
Components and Setup
7
Connect the System Cables
7
The Printer
8
The Pole Attachment
9
Hospital Electronics System Password Access
9
Take a Pressure Measurement
9
Enter the Patient and Sensor Information
9
Acquire the Sensor Signal
11
Set the Baseline
11
Take a Reading
12
Transfer the Data
13
Verify the Patient Setup on the Merlin.net Patient Care Network Heart Failure Management Application
13
Patient Electronics System Setup
13
Setup with a Wireless Connection
14
Setup Without a Wireless Connection
15
Patient Training
16
Pulmonary Artery Catheter Setup
17
Take a Follow-Up Reading
17
Retrieve the Patient Information
17
Acquire the Sensor Signal
18
Take a Reading
18
Transfer the Data
18
Locate the Sensor Signal
18
Optimize the Signal Strength
19
Technically Suspect Readings
19
Patient Position
20
Interference
20
Troubleshooting the Patient Electronics System
20
Manual Setup Instructions
21
Hospital Electronics System
21
Patient Electronics System
22
Hospital Electronics System Follow-Up
22
Additional Hospital Electronics System Functions
22
Wireless Connectivity Setup
22
Set the Baseline in a Follow-Up Reading
22
The Settings Screen
23
The Admin Screen
23
Software Update
24
Additional Patient Electronics System Functions
24
View the Pressure Values During a Reading
24
Guidelines for the Management of Hemodynamic Parameters
25
Elevated PA Pressures (Hyper-Volemic)
25
Low PA Pressures (Hypo-Volemic)
26
Recommended Frequency of Cardiomems HF System Review
26
Cleaning
26
Storage
26
User/Owner Responsibility
26
Electromagnetic Interference and Electromagnetic Compatibility
27
FCC and Industry Canada Statement
29
RTTE Statement
29
WEEE Compliance Statement
29
EU REACH SVHC Disclosure
29
System Specifications
30
Electrical Characteristics
30
Mechanical Characteristics
30
Environmental Information
30
Classification
30
Testing
30
EMI/EMC Testing
31
Wireless Testing
31
Software
31
Technical Support
31
Symbols
31

St. Jude Medical CardioMEMS CM3000 User Manual (32 pages)

HF System, PA Sensor and Delivery System

Brand: St. Jude Medical | Category: Medical Equipment | Size: 0 MB

Table of Contents
3
Description
4
Indications
5
Contraindications
5
Clinical Considerations for Patient Selection
5
Warnings
5
Precautions
6
MRI Information
7
Explant and Disposal
8
Potential Adverse Events
8
Instructions for Use
9
- Personnel Training
  9
- Accessories
  9
- Package Inspection
  9
- Package Contents
  9
- Sterilization
  9
- Pre and Post Procedure Antiplatelet Regimen
  10
Implantation Procedure
10
- Hospital Electronics System Setup
  10
- Right Heart Catheterization and Sensor Implant Procedure
  11
Patient Identification Card
12
Patient Counseling Information
12
Clinical Study Information
13
- Introduction
  13
- Purpose
  13
- Methods
  13
- Patient Demographics and Disposition
  14
- Primary and Secondary Endpoint Results
  15
- Primary Safety Endpoints
  15
- Primary Efficacy Endpoint
  16
- Secondary Endpoints
  16
- Medical Management
  17
- Results from the Entire Randomized Access Period
  17
- HF Hospitalizations
  17
- Mortality
  17
- Freedom from Death or First HF Hospitalization
  17
- All Cause Hospitalizations
  17
- Death or All Cause Hospitalizations
  18
- Results from the Open Access Period (Longitudinal Analysis)
  18
- Treatment Effects in Women
  18
- Adverse Events
  21
FCC Statement
31
Technical Support
31

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