Boscarol OB 2012 FA - Table of Contents

ED01_REV01-2020 IFU OB2012-2P_ENG
3 - 36
TABLE OF CONTENTS
TABLE OF CONTENTS .................................................................................................................................................. 3
0. MEANING OF SYMBOLS AND PICTOGRAMS ..................................................................................................... 4
0.1. Symbols used in these operating instructions to call the reader’s attention ................................................... 4
0.2. Symbols used on the device and accessories .................................................................................................... 4
0.3. Symbols used on battery and referred to in these operating instructions ....................................................... 5
1. INTENDED USE ................................................................................................................................................. 6
2. WARNINGS, PRECAUTIONS AND IMPORTANT INFORMTION ........................................................................... 7
3. INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE ........................................................................... 9
4. CONTRAINDICATIONS (DO NOT USE FOR) .......................................................................................................10
5. SIDE EFFECTS (POSSIBLE DURING ASPIRATION OPERATIONS) .........................................................................10
6. MEDICAL SUCTION UNITS OB 2012 .................................................................................................................10
6.1. Description of the suction unit ........................................................................................................................ 11
6.2. Controls, operations and control panel .......................................................................................................... 11
6.3. Indicator lights ................................................................................................................................................. 12
6.4. Periodic testing of suction units OB2012 ........................................................................................................ 12
6.4.1. Daily periodic testing of suction units OB2012 ............................................................................................... 12
6.4.2. Six-monthly/yearly test of suction units OB2012 ............................................................................................ 13
6.5. Periodic safety maintenance ........................................................................................................................... 15
6.6. Safety information to ensure user, patient and third part safety ................................................................... 15
7. JARS FOR OB2012 ...........................................................................................................................................15
7.1. Autoclavable jar OB-J FA ................................................................................................................................. 16
7.2. Antibacterial filter ........................................................................................................................................... 16
7.3. OB-J LINER: jars for SERRES® disposable liners ............................................................................................... 17
7.4. Connecting the jar ........................................................................................................................................... 17
7.5. Sterile, disposable Yankauer catheter with suction control system ............................................................... 17
7.6. Silicone suction tube and sterile Fingertip connection (conical connector) ................................................... 18
7.7. Warnings regarding the reuse of disposable parts ......................................................................................... 18
8. REUSE, CLEANING AND DISINFECTION ............................................................................................................18
8.1. Reuse of jar OB-J FA ........................................................................................................................................ 19
8.2. Cleaning, disinfection and/or sterilization of jar OB-J FA and silicone tube ................................................... 20
8.3. Assembling the jar and connecting the silicone suction tube ......................................................................... 21
8.4. Replacing the antibacterial filter ..................................................................................................................... 21
8.5. Cleaning the jar with SERRES® disposable liners ............................................................................................. 22
8.6. Disinfection and/or sterilization of jar OB-J and silicone tube ........................................................................ 23
8.7. Assembly of jar with SERRES® disposable liners ............................................................................................. 24
8.8. Disposal of contaminated parts ...................................................................................................................... 24
8.9. Suction unit cleaning and disinfection ............................................................................................................ 24
8.10. Cleaning and disinfection plan ........................................................................................................................ 26
9. ACCESSORIES AND OPTIONAL PARTS FOR OB2012 .........................................................................................26
10. INTERNAL BATTERY FOR SUCTION UNITS FOR OB2012 ...................................................................................27
11. SPECIAL USAGE CONDITIONS ..........................................................................................................................27
12. DEMOLITION OF THE SUCTION UNIT ...............................................................................................................27
13. ACCESSORIES, CONSUMABLES AND SPARE PARTS ..........................................................................................28
14. TECHNICAL SERVICE ........................................................................................................................................29
14.1. Troubleshooting .............................................................................................................................................. 29
15. TECHNICAL AND COMPLIANCE DATA FOR OB2012..........................................................................................30
16. INFORMATION ON ELECTROMAGNETIC COMPATIBILITY EMC FOR SUCTION UNITS OB2012 ..........................31
16.1. RISKS OF MUTUAL INTERFERENCE WITH OTHER DEVICES .............................................................................. 31
16.2. METHODS TO PREVENT ELECTROMAGNETIC INTERFERENCE ......................................................................... 32
16.3. MANUFACTURER GUIDELINES AND DECLARATION – ELECTROMAGNETIC EMISSIONS .................................. 32
16.4. MANUFACTURER GUIDELINES AND DECLARATION – ELECTROMAGNETIC IMMUNITY .................................. 32
17. DECLARATION OF CONFORMITY .....................................................................................................................34
18. WARRANTY .....................................................................................................................................................35