09060 Issue 1
3
Page
of 40
EN
Alpha - Instructions for Use
Contents
1. Main Components .................................................................................4
1.1. Features .....................................................................................5
2. Setting up the device ............................................................................5
3. Operating Instructions ...........................................................................5
3.1. Entering Subject Data ................................................................7
3.2. Conducting a Test ......................................................................8
3.3. Reporting .................................................................................11
3.4. Calibration Verification
............................................................14
3.5. Connection to Electronic Medical Records (EMR)
via Vitalograph Connect .........................................................15
4. Cybersecurity Considerations .............................................................19
4.1. Specification
............................................................................19
4.2. Security Recommendations ....................................................19
4.3. Interfaces .................................................................................20
5. Power Management ............................................................................20
5.1. Battery Pack .............................................................................20
5.2. Battery Power Indications ......................................................20
5.3. Power Save Mode ....................................................................21
6. Cleaning & Hygiene .............................................................................21
6.1. Preventing Cross-Contamination of Subjects ........................21
6.2. Inspection of the Vitalograph Model 6000 Alpha ..................22
7. Fault Finding Guide ..............................................................................23
7.1. Software Check ........................................................................24
7.2. Product Useful Life Checks .....................................................24
8. Customer Service ................................................................................25
9. Consumables and Accessories ..........................................................25
10. Disposal ...............................................................................................26
11. Explanation of Symbols ......................................................................26
12. Description of the Vitalograph Model 6000 Alpha ............................27
12.1. Indications for Use ..................................................................28
13. Technical Specification
.......................................................................28
14. Contraindications, Warnings, Precautions and
Adverse Reactions ...............................................................................30
15. CE Notice .............................................................................................32
16. FDA Notice ...........................................................................................35
17. EU Declaration of Conformity .............................................................35
18. Guarantee & Free Five Year Warranty .................................................36
