FreeHand 1.2 Manual de usuario
Freehand 2010 Ltd
USER MANUAL VERSION 2.5
Part Number: STDS-X-0116
Date of issue December 2020
FREEHAND 1.2
USER MANUAL
USER MANUAL
FreeHand 1.2 User Manual Version 2.5 Page 1 of 61
© Freehand 2010 Limited
No part of this document may be reproduced or transmitted in
any form or by any means, electronic or mechanical, for any
purpose without the express permission of Freehand 2010 Ltd.
The content of this document is furnished for informational use
only, is subject to change without notice and should not be
construed as a commitment by Freehand 2010 Ltd.
FreeHand® is a Registered UK & International Trademark of
Freehand 2010 Ltd.
All other trademarks and registered trademarks are the
properties of their respective companies or mark holders.
UK & International Patents have been granted and are pending
on the FreeHand® product.
EC Registered Community Design No 000996343-002.
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
FreeHand 1.2 User Manual Version 2.5 Page 3 of 61
4.4 Indicator Unit Symbols........................................................ 53
5. Troubleshooting................................................................... 57
6. Technical Specifications...................................................... 58
FreeHand 1.2 User Manual Version 2.5 Page 4 of 61
How to Contact Us:
The entire team at Freehand 2010 Ltd is dedicated to providing
you with the excellent support and service that you deserve.
Your local representative will provide the day-to-day contact
and support that you require.
For customers in the UK & EU
Freehand 2010 Limited
Unit 2, Weyvern Park
Portsmouth Road,
Guildford
GU3 1NA
United Kingdom
Phone: +44 (0) 1483 408720
Fax: +44 (0) 1483 452690
For customers in the USA
Mediflex Surgical Products
250 Gibbs Road
Islandia
NY
11749
USA
Phone: +1 631-582-6424
For sales and support:
Tel
Fax
e-mail
UK
01483 408720
01483 452690
orders@freehandsurgeon.com
USA
+1 631 582 6424
+1 631 582 4520
INT
+44 (0) 1483
408720
+44(0) 1483
452690
orders@freehandsurgeon.com
FreeHand 1.2 User Manual Version 2.5 Page 5 of 61
1. Introduction
Congratulations on choosing the FreeHand®robotic camera
controller. We are confident that your system will provide you
with years of trouble-free operation.
Ensuring your complete satisfaction is our highest priority. You
can be assured that our expert team and partner companies
will provide you with all the training and support that you need,
and the excellent service that you require.
We value your feedback and suggestions on ways in which we
can further improve our products and services. Please do not
hesitate to contact us; all the numbers and addresses are at
the front of this manual.
1.1 Training
As a new FreeHand customer, we want to ensure that you and
your team get up to speed as rapidly as possible. Following
receipt of your new system, a representative of Freehand 2010
Ltd, or of one of our certified partner companies, will carry out
a comprehensive program of in-service training. The objectives
of this program are as follows:
For Surgeons:
Optimal positioning of FreeHand for the required surgical
procedures.
Using FreeHand to position and move the endoscope.
For Nurses and operating room technical staff:
Set-up of FreeHand.
Fitting the Sterile Sleeve and Disposable Zoom Module.
Overview of FreeHand operation.
FreeHand 1.2 User Manual Version 2.5 Page 6 of 61
Routine maintenance and problem solving.
At the completion of this program, all surgeons and staff will be
confident in the routine setup, operation and use of FreeHand.
Following the program your representative will, of course, be in
regular contact to answer any additional questions that may
arise as you become fully familiar with your system.
1.1.1 Update Training Programs
From time-to-time you may feel that you need some update
training for one or more members of your staff. This may be
due to new surgeons or nurses joining your team, or perhaps
you wish to use FreeHand in a new range of endoscopic
procedures. Whatever the reason, just contact your local
representative and he or she will be pleased to arrange a
tailored Update Training Program to meet your needs.
1.2 System Description
FreeHand is an robotic camera controller which is fixed to the
operating table. FreeHand holds the ’scope, providing a rock
steady image throughout the surgical procedure, however long.
Selecting the direction of movement of the ‘scope is effected by
the surgeon through natural head movements, with motion
activated by depressing a Footpedal. FreeHand provides the
full range of ‘scope motion required during the procedure,
including pan, tilt and zoom. Comprehensive safety features
have been built into the design, which have been extensively
tested and certified by independent laboratories.
FreeHandprovides the following benefits for the user:
•Complete personal control of the camera position and
movement, eliminating any communication issues with
assistants, or inconsistencies in the standard of camera
control due to assistants of variable skill levels.
•Provides a rock-steady image, eliminating camera shake
or unnecessary movement, improving the surgeon’s view
and ensuring a stable, comfortable and safe environment.
FreeHand 1.2 User Manual Version 2.5 Page 7 of 61
•Removes the need for camera holding assistant.
1.3 FreeHand System Parts
FreeHandconsists of the following parts (see Figures):
1. The Control Box containing the main electronics and
power supply. There is a clamp on the rear surface of the
Control Box which is used to fix the equipment to the
operating table.
2. The Arm, bearing the Robotic Motion Assembly. The
Speed Control Panel is located on the Robotic Motion
Assembly.
3. The battery-powered Hands-Free Control Unit
(Headset). This is provided with a lanyard and is mounted
on the surgeon’s head.
4. The Indicator Unit that displays the direction of ‘scope
movement that has been selected by the user.
5. The Footpedal that enables the selected movement.
6. A sterile, single-use pack comprising:
•The Sterile Zoom Module. This holds the ‘scope and
contains the motor required to move it in and out of the
port (“zoom”). This must be attached to the Robotic
Motion Assembly before use.
•Scope Clip. This will accommodate rigid ‘scopes with
external diameters of between 5mm and 10mm. It
attaches to the main body of the Zoom Module.
FreeHand 1.2 User Manual Version 2.5 Page 8 of 61
•Positioning Template. May be used to confirm that the
Robotic Motion Assembly is at the correct distance from
the patient’s skin surface at the camera port.
7. A Sterile Sleeve to cover the Robotic Motion Assembly,
Arm and Control Box.
A custom-designed mobile cart is also available to help with
storage of the FreeHand system between patient cases, and
for ease of movement between operating rooms.
FreeHand System Parts
FreeHand 1.2 User Manual Version 2.5 Page 9 of 61
FreeHand Control Box
FreeHand Robotic Motion Assembly and Sterile Zoom Module
Este manual sirve para los siguientes modelos
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