FreeHand 1.2 User Manual Version 2.5 Page 2 of 61
Table of Contents
1. Introduction ............................................................................ 5
1.1 Training............................................................................ 5
1.1.1 Update Training Programs...................................... 6
1.2 System Description.......................................................... 6
1.3 FreeHand System Parts .................................................. 7
1.4 Sterile Zoom Module –single-use protection................. 11
1.5 Application Specification................................................ 11
1.6 Contraindications......................................................... 122
1.7 Precautions.................................................................... 12
1.8 Warnings ....................................................................... 13
1.9 Caution.......................................................................... 15
1.10 Conformance to Standards............................................ 16
1.11 Declaration of Conformity.............................................. 17
1.12 Adjustment and Replacement of Parts .......................... 17
1.13 Defects and Abnormal Stresses .................................... 18
1.14 Modifications.................................................................. 18
1.15 Explanation of Markings ................................................ 19
1.16 Manufacturer ................................................................. 21
2. Preparing and Setting up FreeHand ................................... 22
2.1 Before using FreeHand for the first time........................ 24
2.2 Setting up FreeHand...................................................... 24
2.2.1 During Patient Preparation –FreeHand Initial setup. 24
2.2.2 Re-setting the Control System………………………...29
2.2.3 Fitting the Sterile Sleeve ........................................... 29
2.2.4 Connecting the Zoom Module and the ’scope ........... 32
2.2.5 Positioning FreeHand at the camera port.................. 34
3. Using FreeHand.................................................................... 38
3..1 Setting the speed of movement ............................ 38
3..2 Controlling movement with the Headset ............... 38
3.2.1 Selecting the direction of movement……………....39
3.2.2 Selecting direction of movement in Tilt mode…….40
3.2.3 Selecting direction in Zoom mode………………….41
3.3 Activating movement………………………………..43
3.4 Changing direction of movement while moving..... 43
3.5 Temporarily disconnecting the ‘scope................... 44
3.6 Stop Switch........................................................... 45
3.7 Removal of FreeHand from the operating table.... 46
3.8 Using the FreeHand Storage Cart......................... 47
4. Maintenance.......................................................................... 49
4.1 Cleaning and Disinfection.............................................. 49
4.2 User Replaceable Parts/Routine Inspection.................. 50
4.3 Consumable and other Parts......................................... 51