FreeHand 1.2 User manual

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: [phone]
Fax: [phone]
For customers in the USA
Mediflex Surgical Products
250 Gibbs Road
Islandia
NY
11749
USA
Phone: [phone]
For sales and support:
Tel
Fax
e-mail
UK
01483 408720
01483 452690
[e-mail]
USA
[phone]
[phone]
[email protected]
INT
+44 (0) 1483
408720
+44(0) 1483
452690
[e-mail]

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

FreeHand 1.2 User Manual Version 2.5 Page 10 of 61
FreeHand, surgeon interface
1.4 Sterile Zoom Module –single-use protection
The Sterile Zoom Module is intended for single use only. To
guard against inadvertent re-use of this item, a protection
system prevents the Zoom Module from being used a second
time –an internal electronic protection chip in the Zoom Module
will automatically mark the zoom as “used” after it has been
attached to the Robotic Motion Assembly. The following rules
must be followed when fitting and using the Zoom Module.
1. The Sterile Zoom Module will be marked as “used” when it
has been attached to the Robotic Motion Assembly. DO NOT
DISCONNECT THE ZOOM MODULE, OR TURN OFF THE
POWER TO FREEHAND, UNTIL THE COMPLETION OF
THE PROCEDURE.

FreeHand 1.2 User Manual Version 2.5 Page 11 of 61
2. Momentary power interruptions will not cause the Sterile
Zoom Module to be locked.
3. A Sterile Zoom Module has maximum usage duration of 8
hours. After this time it will be automatically locked. In the
event that a single patient case is expected to be of a duration
longer than 8 hours, a second Zoom Module should be made
ready and fitted prior to reaching 8 hours of use.
1.5 Application Specification
The intended medical indication for FreeHand is in general
laparoscopy, general thoracoscopy, general cardiothoracic
surgery, nasopharyngoscopy, ear endoscopy and sinuscopy,
(where a rigid laparoscope/endoscope is required) during, for
example, laparoscopic* cholecystectomy, hernia repair,
fundoplication, splenectomy, appendectomy, hemicolectomy,
sympathectomy, lymph node dissection, hysterectomy,
gastric banding, gastric bypass, nephrectomy, radical
prostatectomy, anterior spinal fusion, decompression fixation,
wedge resection, lung biopsy, pleural biopsy, internal
mammary artery dissection for coronary artery bypass,
coronary artery bypass grafting where endoscopic
visualization is indicated, examination of the evacuated
cardiac chamber during performance of valve replacement or
repair.
*In this context “laparoscopic” is taken to embrace the use of
a rigid endoscope in any part of the body.
At all sites on the body where FreeHand might be used, note
that FreeHand holds the ‘scope and does not directly contact
or interact with tissue.
The intended patient population (by age, weight, health or
condition) includes all patients deemed by the surgeon as
suitable for the relevant laparoscopic procedure.

FreeHand 1.2 User Manual Version 2.5 Page 12 of 61
The intended user profiles for FreeHand are surgeons and
operating room staff. Users, even before interacting with the
equipment, are presumed to have education, training and
general skills appropriate for the interacting with medical
equipment in an operating room environment.
The intended conditions of use are in a standard hospital
operating theatre with normal operating theatre environment
hygiene requirements with FreeHand being used several times
daily (with a new zoom and new sleeve for each patient).
Although FreeHand is attached to a storage cart when not in
use, it must be firmly attached to the operating table before
each procedure.
FreeHand is an electromechanical medical device whose
operating principle is to hold and manipulate an endoscope.
Selection of the direction of movement is effected by the
surgeon through head
movements. Motion is activated by depressing a pedal.
FreeHand provides the full range of scope motion required
during the procedure, including pan, tilt and zoom.
1.6 Contraindications
None known.
1.7 Precautions
The Sterile Zoom Module, Scope Clip, Positioning Template
and Sterile Sleeve are intended for single use only. Do not
attempt to re-sterilise or re-use.
Follow the correct cleaning instructions of the FreeHand
system to reduce the risk of cross infection.

FreeHand 1.2 User Manual Version 2.5 Page 13 of 61
1.8 Warnings
Warning. Only competent and trained persons should set
up and use this system; read this user manual completely
before attempting to set up or operate FreeHand.
Warning. FreeHand set up must be performed in
accordance with standard hospital infection control
procedures, especially regarding those elements that will
enter the sterile field.
Warning. Ensure that the Table Clamp Knob, Arm Clamp
Knob and Arm Positioning Knob are securely tightened
before removing manual support from arm.
Warning. To prevent it from falling onto the patient, the
torsion adjustment ring should always be at the maximum
pre-tension.
Warning. The Robotic Motion Assembly and Arm should
be manually supported whilst repositioning to prevent the
arm falling onto the patient.
Warning. Inspect all cables for twisting or strain prior to
each use of FreeHand. FreeHand should not be used if
cables are twisted or strained.
Warning. Inspect all cables for damage prior to each use
of FreeHand. FreeHand should not be used if cables are
damaged.
Warning. Ensure power cable and Footpedal cables are
routed to prevent damage and accidental tripping.
Warning. Place the Footpedal in a position on the floor
where it cannot be confused with any other pedals that
may be in use by the surgeon.
Warning. The Sterile Zoom Module is intended for single
use only. A new Sterile Zoom Module must be used for
each patient procedure.
Warning. The Sterile Sleeve must be fitted prior to use
of FreeHand.
Warning. The Sterile Sleeve is intended for single use
only. A new Sterile Sleeve must be used for each patient
procedure.
Warning. Do not attempt to re-use or re-sterilize any of
the sterile parts; they are intended for single use only.

FreeHand 1.2 User Manual Version 2.5 Page 14 of 61
Warning. The Sterile Zoom Module and Sterile Sleeve
must be fitted by a scrubbed person taking care to
maintain good sterile technique and ensuring that sterility
is not compromised.
Warning. Do not attempt to use the Sterile Zoom Module
or Sterile Sleeve if the packaging of these items appears
to have been pierced, damaged or torn.
Warning. Check that FreeHand is rigidly attached to the
operating table and all attachments are secure prior to
use.
Warning. When attaching the ‘scope to the Zoom Module
you should observe the monitor image and take care that
the ‘scope does not accidentally come into contact with
patient tissue. Adjust the position in the Scope Clip as
required.
Warning. Ensure that the desired direction of movement
is showing on the Indicator Unit before pressing the
Footpedal.
Warning. Do not use in the presence of flammable
anaesthetics, or flammable cleaning agents.
Warning. Connect only FreeHand system parts together
/ to the sockets on FreeHand’s control box.
Warning. Always select a movement speed that is at a
safe limit before operation.
Warning. Keep hands clear of driven parts when in
motion.
Warning. Check that the “coin cell” batteries are securely
in place in the Headset prior to use.
Warning. Do not remove covers. There are no user-
serviceable parts inside.
Warning. Protect all connections from liquid spills.
Warning. Refer servicing to qualified Freehand 2010 Ltd
service personnel.
Warning. Use only original system parts supplied by
Freehand 2010 Ltd.

FreeHand 1.2 User Manual Version 2.5 Page 15 of 61
1.9 Caution
Federal (USA)law restricts this device to sale by or on the order
of a medical practitioner licensed by the law of the State in
which that person practices to use or order the use of the
device.

FreeHand 1.2 User Manual Version 2.5 Page 16 of 61
1.10 Conformance to Standards
FreeHand has been certified in accordance with the following
standards:
ANSI/AAMI
ES60601-
1:2005/(R)2012
Medical electrical equipment - Part
1: General requirements for safety
IEC 60601-1:2005 +
A1:2012
BS EN 60601-
1:2006+A12:2014
CAN/CSA-C22.2
NO. 60601-1:14
IEC 60601-1-2:2014
Medical electrical equipment; Part
1-2: General requirements for basic
safety and essential performance;
Collateral standard:
Electromagnetic compatibility,
Requirements, and tests
BS EN 60601-1-2:
2015
FCC CFR 47: Part
15: B: 2012
Electromagnetic compatibility,
Requirements, and tests

FreeHand 1.2 User Manual Version 2.5 Page 17 of 61
Class of Device
The Control Box and Indicator Unit is equipment with external
power sources and the hands-free control unit is equipment
with an internal electrical power source.
Protection against the harmful ingress of water.
Hands-free Control Unit (Headset)
Indicator Unit
Sterile Zoom Module
Control box with Sterile Sleeve fitted
Note: the Sterile Sleeve must be fitted to
afford this protection.
Footpedal
IPX0
IPX0
IPX1
IPX1
IPX8
Rated for non-continuous operation. Duty cycle (over 4
minutes): total activation time 0.5 minutes maximum, total
deactivation time 3.5 minutes minimum.
1.11 Declaration of Conformity
FreeHand is in conformity with the essential requirements and
provisions of Council Directive 93/42/EEC and as amended,
concerning medical devices.
1.12 Adjustment and Replacement of Parts
FreeHand requires no routine calibration or adjustments to
maintain operation and must only be serviced or repaired by
Freehand 2010 Ltd or a Freehand Service and Repair Centre
and not by the user or the user’s agent. Circuit diagrams,
component listings and servicing instructions are not made
available to users.

FreeHand 1.2 User Manual Version 2.5 Page 18 of 61
Cleaning and Disinfection instructions are provided in section
3.1.
Details of User-replaceable parts and a list of system parts and
consumable items are provided at the end of this User Manual.
1.13 Defects and Abnormal Stresses
For continued safety FreeHand must not be maltreated or used
outside of its specified storage or operational conditions.
FreeHand contains protection against the effects of
electrostatic discharge, but it is not protected against the
currents produced by external heart defibrillators. To avoid
damage FreeHand must be disconnected and removed before
defibrillation.
Whenever it is likely that protection has been impaired,
FreeHand shall be made inoperative and secured against any
unintended operation. The protection is likely to be impaired if,
for example, the system:
(a) Shows visible damage.
(b) Has twisted or strained cables
(c) Fails to perform as intended.
(d) Has been subjected to prolonged storage under
unfavourable conditions.
(e) Has been subjected to severe transport stresses.
(f) Has been in contact with a patient during
defibrillation.
1.14 Modifications
WARNING: No modification of this equipment is allowed.

FreeHand 1.2 User Manual Version 2.5 Page 19 of 61
For continued safety, FreeHand must not be subjected to any
unauthorised modifications and must be used only for the
purpose for which it was originally supplied.
1.15 Explanation of Markings
Alternating Current
CLASS II EQUIPMENT (double insulated)
This equipment must not be disposed of
together with ordinary waste but either
returned to the manufacturer or transferred to
a specialist collector of used electrical and
electronic products
Caution, consult accompanying documents
Warning, consult accompanying documents
Follow Instructions For Use
Emergency stop
Keep dry