Alesi Surgical Ultravision User manual

User Manual
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Benutzerhandbuch
Manuel de l’utilisateur
Manual de usuario
Manuale Utente
Issue v7.0

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Foreword
This manual and the equipment it describes are for use only by qualied medical professionals who have been trained to use
electrosurgicalequipment.
Equipment covered in this manual:
Ultravision™ visual eld clearing system, comprising:
Item Part number
Ultravision™Generator DAD-001-010
Ultravision™ Battery(x2) DSD-001-034
Ultravision™Battery Recharging Station DAD-001-024
Ultravision™ Mains Converter Power Supply* DAD-004-009
Ultravision™ Mains Converter* DAD-004-012
Ultravision™ Power Supply Unit DSD-001-035
Ultravision™ Patient Return Adaptor (Solid) 0.75M DAD-001-006
Ultravision™ Patient Return Adaptor (Split) 0.75M DAD-001-007
Ultravision™ Patient Return Adaptor (Solid) 1.5M DAD-001-029
Ultravision™ Patient Return Adaptor (Split) 1.5M DAD-001-030
Ultravision™ Patient Return Adaptor (Euro) DAD-001-031
Ultravision™ 5mm Trocar* (single) DAD-003-013
Ultravision™ 5mm Trocar* (x6) DAD-003-014
Ultravision™ 5mm Trocar* (x60) DAD-003-015
Ultravision™ Ionwand™ Sterile Pack* DAD-001-003
*supplied separately or incorporated within a mains powered Ultravision™ visual eld clearing system starter pack variant
Patents pending
Worldwide patents are pending for the Ultravision™ system, including PCT/GB2010/051196 and PCT/GB2012/052707.
Trademarks
Ultravision™ and Ionwand™ are trademarks of Alesi Surgical Limited.
Manufacturer
Alesi Surgical Limited Cardiff Medicentre Heath Park
Cardiff, CF14 4UJ, U.K.
http://www.alesi-surgical.com
For information call [phone].
MEDICAL - GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-6 (2010, A1:2013) CAN/CSA-C22.2
No. 60601-1-6 (2011, A1:2015)
© Alesi Surgical Limited, 2018. All rights reserved.

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Terms Used in this Manual
Warning
Indicates a situation which, if not avoided, could result in death or serious injury.
Caution
Indicates a situation which, if not avoided, may result in minor or moderate injury.
Be aware
Indicates that the operator should be aware of a hazard that may damage the product.
Advice
Indicates advice to the operator to optimise performance of the system.
Statement on Electromagnetic Compatibility
The Ultravision generator and battery recharging station require special precautions regarding Electromagnetic Compatibility
(EMC) and need to be installed and put in to service according to the EMC information provided in Chapter 9.
Portable and mobile RF communications equipment can affect the Ultravision generator and battery recharging station.
Ultravision™ system warning
No modication of this equipment is allowed.
Warranty
Please consult term and conditions of sale for details of the warranty offered with the Ultravision system and its components.

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Table of contents
Foreword ....................................................................................................................................................................................2
Terms Used in this Manual..........................................................................................................................................................3
Statement on Electromagnetic Compatibility..............................................................................................................................3
Ultravision™ system warning......................................................................................................................................................3
Warranty......................................................................................................................................................................................3
Table of contents.........................................................................................................................................................................4
Chapter 1: Ultravision™ – overview and general features..........................................................................................................6
Indications for use...................................................................................................................................................................6
Contraindication ......................................................................................................................................................................6
Parts shipped with the Ultravision™ system ...........................................................................................................................6
The Ultravision™ system – principle of operation...................................................................................................................7
Operating Parameters.............................................................................................................................................................8
Transport and Storage.............................................................................................................................................................8
Patient, Operating Room and General Use Safety .................................................................................................................9
Maintenance..........................................................................................................................................................................10
Chapter 2: Controls, Sockets and Indicators ............................................................................................................................ 11
Ultravision™ generator – Front panel view ........................................................................................................................... 11
Ultravision™ generator – Side panel view ............................................................................................................................12
Ultravision™ generator – Rear view......................................................................................................................................13
Ultravision™ Battery Recharging Station Option – Top view .................................................................................................13
Ultravision™ Main Converter Option – Front panel view ......................................................................................................14
Chapter 3: Preparing the Ultravision™ system for use.............................................................................................................15
Periodic Inspection................................................................................................................................................................15
Charging the battery using the Ultravision™ Battery RechargingStation .............................................................................15
Inserting the battery into the Ultravision™ generator............................................................................................................16
Operation of the Ultravision™ Generator using the optional Ultravision™ Mains Converter................................................16
Inserting the Mains Converter into the Ultravision™ generator.............................................................................................16
Preparing Ultravision™ for use - Instruments requiring a patient returnelectrode................................................................17
Preparing Ultravision™ for use – Instruments that do not require a patient returnpath .......................................................17
Chapter 4: Using the Ultravision™system ...............................................................................................................................19
Inserting the Catheter, trocar and Ionwand ...........................................................................................................................19
Use of the Catheter, Trocar and Ionwand during surgery......................................................................................................20
End of surgery.......................................................................................................................................................................20
Insertion of the Ultravision 5mm Trocar .................................................................................................................................21
Use of the Ultravision 5mm Trocar during surgery ...............................................................................................................21
End of surgical procedure .....................................................................................................................................................21
Chapter 5: Aftersurgery............................................................................................................................................................23
Cleaning the Ultravision™ Patient ReturnAdaptor................................................................................................................23
Post surgery actions with the mains converter......................................................................................................................23
Cleaning the Ultravision™ Generator....................................................................................................................................23

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Cleaning the Ultravision™ Battery Rechargingstation..........................................................................................................23
Recharging the Ultravision™ battery.....................................................................................................................................24
Disposal ................................................................................................................................................................................24
Chapter 6:Troubleshooting.......................................................................................................................................................25
Chapter 7: Summary System Specications ............................................................................................................................27
Chapter 8: Accessories and replacement items........................................................................................................................29
Chapter 9: Electromagnetic guidance ......................................................................................................................................30
Symbols used on Ultravision ..................................................................................................................................................178

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Chapter 1: Ultravision™ – overview and general features
This section describes the indications for use for the Ultravision surgical smoke visual eld clearing system and its features.
Caution
Read all warnings, cautions, and instructions provided with the Ultravision system before use. Failure to do so could result in
death or serious injury to the patient or operator.
Read the following associated individual manuals as these contain safety relevant information.
Part No. Manual Description
DLU-001-002 Ionwand Pack IFU
DLU-001-003 Patient Return Adaptor IFU
DLU-001-004 Battery Recharging Station IFU
DLU-001-005 Battery IFU
DLU-001-009 Ultravision User Guide
DLU-003-001 Ultravision 5mm Trocar IFU
DLU-004-001 Mains Converter IFU
Indications for use
The Ultravision system is indicated for the clearance of smoke and other particulate matter that is created during laparoscop-
ic surgery by monopolar, bipolar and ultrasonic instruments.
Warning
Do not allow the Ionwand to come in to contact with the uninsulated portion of an electrosurgical instrument during opera-
tion. In such a situation the Ultravision generator issues a continual audio-visual proximity indication. Continued contact for
in excess of 10 minutes may result in an electrical discharge from the electrosurgical instrument that may be sufcient to
cause atrial brillation depending on proximity to the thoracic cavity.
Contraindication
The Ultravision system is an electrical energy-based system that must not be used on patients tted with a pacemaker or
implantable cardioverter debrillator (ICD).
Parts shipped with the Ultravision™ system
The Ultravision system comprises both reusable and single-use, sterile disposable items. The single-use, sterile dispos-
able items are supplied separately. Furthermore, the Mains Converter is an optional form of powering the generator that is
supplied separately or within an alternate Ultravision system starter pack variant. Contact your local sales representative in
order to establish a supply of these items. All other items required for Ultravision to function are shipped with the Ultravision
system.
Before use, conrm that the shipping carton contains the following items:
1. Generator x1
2. Battery x 2 (battery powered system only) x2
3. Recharging station (battery powered system only) x1
4. Mains Power supply unit for recharging station (battery powered system only) x1
5. Mains converter including power supply (mains powered system only) x1
6. Solid-plate patient return adaptor x1
7. Split-plate patient return adaptor x1
8. User manual x1
If any of the items listed above are not in the shipping carton, please contact your local sales representative before attempt-
ing to use the system.
Prior to use, inspect all of the above parts for any damage that may have occurred during shipping. If you have any con-
cerns, please contact your local sales representative before using the system.
The following reusable items will require replacement:

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Item Approximate number of uses before requiringreplacement
Battery First to occur of 2 years, 200 charging cycles at 20°C (68°F) or 1 year from last recharge
at 20°C (68°F).
Patient return adaptor (solid) 500 mating cycles with Ultravision generator and electrosurgical generator
Patient return adaptor (split) 500 mating cycles with Ultravision generator and electrosurgical generator
Battery recharging station 1000 mating cycles with Ultravision battery
Mains Converter 100 mating cycles with Ultravision generator
Replacement reusable items are available from Alesi Surgical or its local distributors.
The Ultravision™ system – principle of operation
The Ultravision system removes the particulate material that is created by energy-based instruments during laparoscopic
surgery from the visual eld. It achieves this by electrostatic precipitation, a process that transiently charges the particulate
matter and causes it to be rapidly precipitated inside the peritoneal cavity as it is created. The system has been specically
designed to improve the clarity of the visual eld and to minimise the release of particulate matter and gases into the operat-
ing theatre environment during laparoscopic surgery.
The Ultravision system requires a patient return pathway, similar to monopolar diathermy but at 5 orders less current magni-
tude. The system has been designed such it can be congured in two ways, depending upon the type of cutting instrument
that is used:
With monopolar instruments that require a patient returnelectrode
The Ultravision system is provided with a Patient Return Adaptor that allows the electrosurgical unit and the Ultravi-
sion generator to share a single patient return electrode with the monopolar instrument (Figure 1).
With bipolar and ultrasonic cutting instruments that do not require a patient returnpathway
The Ultravision patient return socket in the generator allows a standard patient return electrode to be used and con-
nected directly to the Ultravision generator (Figure 2).
The Ultravision system is not supplied with a patient return electrode but has been designed to be compatible with patient
return electrodes that have an “international” style connector. Please contact Alesi Surgical or your local distributor if you ex-
perience any problems with your preferred patient return electrode.
Figure 1: Ultravision™ set up for use with instruments that do
require a patient return electrode
Figure 2: Ultravision™ set up for instruments that do
not require a patient returnelectrode
The following components are required for Ultravision to function and are supplied with the system:
1. The generator unit
The generator unit is the source of the high voltage at low power. The output power is regulated automatically and cannot be
adjusted manually. The unit is operated with power provided by a removable and rechargeable battery or an optional.
mains converter.

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2. The battery
The generator is powered by a battery that allows approximately 10 hours of continuous generator operation. The system is
supplied with two batteries and a recharging station. As with all batteries of this type, the life will depend upon the number of
recharges. It is recommended that batteries should be replaced every 12 months or when a fully charged battery no longer
delivers six hours of generator power.
3. The mains converter
Depending on customer preference, the generator can also be powered by a mains converter that allows the unit to be pow-
ered the mains supply using its bespoke power supply unit. This power supply unit has a choice of four different plug styles
that allows it to be used in most countries and has a universal input allowing 90-264V AC. The Mains Converter is designed
so that it can be stored within the battery bay of the Ultravision generator when not in use.
4. Battery recharging station
The Ultravision system is supplied with a twin-bay recharging station and a mains power supply unit different from that de-
signed for use with the mains converter. The battery recharger mains power supply unit has four different plugs that allow it
to be used in most countries and has a universal input allowing 90-264V AC.
5. Patient return adaptor – solid plate
The Ultravision system requires a patient return electrode. The patient return electrode can be shared with the solid or split
plate return electrode of the electrosurgical generator if one is required, by using the patient return adaptor. The “solid plate”
patient return adaptor is used with solid plate patient return electrodes. The blue end of the adaptor plugs into the socket on
the front of the electrosurgical generator. The orange connector at the other end of the cable plugs into the front of the Ultra-
vision generator. These are available with 0.75 or 1.5M leads.
6. Patient return adaptor – split plate
This is the same as the solid plate patient return adaptor but is used with split plates. It has the same central pin that acti-
vates the sensing function of the electrosurgical generator (if present). The split plate adaptor end is red in colour. These are
available with 0.75 or 1.5M leads.
The following single-use, sterile disposable components are required for Ultravision to function and are supplied as separate
items:
7. Ionwand™
The Ionwand is the active cable that carries the current from the Ultravision generator to the patient. It terminates in an
atraumatic stainless steel brush that is responsible for the electrostatic charging of the particles created during surgery.
8. Catheter and trocar
The catheter allows the Ionwand to be inserted into the patient’s peritoneal cavity during surgery. It is introduced percutane-
ously using the trocar.
9. Ultravision 5mm Trocar
The Ultravsiion 5mm Trocar is an alternative to the Ionwand™, catheter and trocar and comprises a laparoscopic port that
can accept 5mm surgical instruments. This port also has a separate lumen that accepts a dedicated Ionwand™
Operating Parameters
The Ultravision system may be used within the following ranges
• Ambient temperature range 10°C to 40°C (50°F to 104°F)
• Relative humidity 20% to 75%, non-condensing operating room conditions
• Altitude below or equal to 3000m (above 70kPa)
Transport and Storage
• Ambient temperature range -10°C to 40°C (14°F to 104°F) except batteries
• Relative humidity 20% to 85%, non-condensing
• Battery ambient temperature range 0°C to 40°C (32°F to 104°F). Prolonged exposure to higher temperatures will
signicantly reduce battery shelf life.
• Battery shelf life – 1 year from last recharge at 20°C (68°F)
• Altitude below or equal to 3000m (above 70kPa)

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Patient, Operating Room and General Use Safety
Warning
Only surgical staff trained to use electrosurgical equipment may operate the Ultravision system.
During initial set up and before each use, inspect the Ultravision system and battery recharging station for any damage. If
damaged, do not use or attempt to repair. Call Alesi Surgical or your local distributor for assistance.
The enclosures for the Ultravision generator, Mains Converter and its Power supply units are plastic with internal isolation
barriers that provide complete insulation to the patient and operator from any internal electrical hazards. In addition, the
patient connections are Cardiac Floating. Consequently, the Ultravision system requires no connection to an equipotential
point or protective earth.
To maximise patient safety, contact between the Ionwand and metallic instruments should be minimised. Otherwise, the
metal instrument may be charged resulting in an electrostatic discharge to the patient or operator. This may be sufcient to
cause atrial brillation depending upon proximity to the thoracic cavity.
If the Ultravision generator, Mains Converter, Power supply units or battery recharging station become wet for any reason,
switch off and air-dry thoroughly before reusing.
Do not position the equipment so that it is difcult to disconnect the direct plug in Power Supply units from the mains.
Do not remove any covers or panels exposing the internal components of the Ultravision system and battery recharging
station. Removal of covers or panels will void any Warranty.
Ensure that the battery is correctly inserted into the Ultravision generator. Failure to do so may result in a re hazard.
Ensure that the UltravisionTM Mains Converter is always inserted into the Ultravision Generator in the correct orientation.
Failure to do so may damage the Mains Converter and equipment.
Do not use the Mains Converter to power equipment other than the Ultravision Generator. This may damage the Mains Con-
verter and equipment.
Do not use any other third party Power Supply to power the Ultravision Generator. This may cause damage to the Ultravision
generator and the third party power supply. The operator is also at risk of electrostatic shock or burn, due to charge build up
in external capacitances.
Do not mechanically shock or drop a Mains Converter. This may damage or reduce the life of the Mains Converter.
Do not hold or suspend the Mains Converter or its power supply by its cable – this may damage the equipment.
Do not operate this device in potentially explosive environments, such as in the presence of ammable anaesthetics.
The battery recharging station has only been certied for use outside the immediate operating theatre environment. It does
not have sufcient redundant voltage or current protection to allow safe contact with the patient.
Use the battery recharging station and the mains converter with their specic mains power supply units. They are not me-
chanically interchangeable and provide different types of electrical protection.
Plug the power cable directly into the power socket without any extension cords or adaptor plugs.
The power cable assembly should be checked periodically for damaged insulation or connectors. Do not use a damaged
power cable.
Do not connect a wet power cable to a power socket.
Inspect any sterile component for damage to the packaging before use. If any damage is present, do not use.
Do not reuse or re-sterilise the Ionwand, trocar, catheter or the Ultravision 5mm Trocar. Doing so may result in cross contam-
ination, infection or injury to the patient or medical staff and may damage the Ultravision system.
Caution
Read all warnings, cautions, and instructions provided with the Ultravision system before using. Do not stack equipment on
top of the Ultravision system.
To maximise patient safety, contact between the Ionwand and patient tissue should be minimised. Otherwise, performance

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will be compromised and visibility will be impaired.
Be aware of trip hazards with the cable of the Ultravision Mains Converter.
Be Aware
For battery powered operation:
• Using any unapproved battery with the Ultravision system may cause damage and will void the warranty.
• Connect the battery charger power cable to a wall socket having the correct voltage. Otherwise, product damage
to the recharger or battery may result.
• Power supply voltages below 90V AC will signicantly reduce the rate of recharging.
For Mains Converter Operation:
• Power supply voltages below 90Vac (to the Mains Converter Power Supply unit) will cause unpredictable genera-
tor behavior (low battery warning or no operation).
Maintenance
Warning
Inspect the Ultravision generator, battery recharging station or mains converter before each use. If there is evidence of dam-
age, do not use. Call Alesi Surgical or its local distributor for assistance.
Always turn off the Ultravision generator before cleaning.
Always unplug the battery recharging station before cleaning.
Always unplug the mains converter power supply unit and remove cable from the mains converter before cleaning.
Caution
Dispose of the Ionwand, trocar and catheter along with other operative waste materials, following the procedures for your
institution.
Be Aware
Use only detergents that are already routinely used in your hospital to clean non-sterile electrosurgical generators and ca-
bles to clean the Ultravision generator, battery recharging station and patient return adaptors. Do not apply alcohol, caustic,
corrosive, or abrasive cleaning or disinfectant compounds, solvents, or other materials that could cause damage.
Do not attempt to sterilise the Ultravision generator or patient return adaptors in any way.
Keep the Ultravision generator and battery recharging station away from liquid. These may damage internal components.