The VentX Console Infiltration , Aspiration and Accessories Users Guide

Infiltration, Aspiration and Accessories User’s Guide

Table of Contents Preface and Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.0

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings, Cautions, Notices, and Symbols... 1 Contraindications... 10 Operator Warnings... 10 Operator Cautions... 11 Indications for Use... 12

2.0 Equipment Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Equipment List... 12 Using the VentX Console and Accessories with the VASER® Amplifier... 15 3.0 Using the VentX® Console and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Before Surgery... 19 During Surgery... 20 After Surgery... 20 4.0 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 5.0 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 6.0 Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Maintenance... 25 Suction Filter Replacement... 25 7.0 Specifications and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Technical Specifications... 28 Voluntary Standards... 34

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T h e Ve n t X ® C o n s o l e

8.0 Installation, Returns, and Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Installation Requirements... 34 Unpacking and Inspection... 35 Assembly of the Equipment... 36 When Installation also includes the VASER/VASER Pro Amplifier... 39 Installation Requirements:... 39 Unpacking and Inspection... 39 Assembly of the Equipment... 40 Performance Testing:... 41 Servicing the VentX Console and Accessories... 43 Return Material Authorization (RMA)... 43 Limited Warranty... 43 Exclusion of Other Warranties... 43

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Infiltration, Aspiration and Accessories User’s Guide

Preface and Introduction Solta Medical thanks you for your recent purchase of the VentX® Infiltration and Aspiration Console. The VentX Console is the industry leading choice for precision infiltration and aspiration for use during body contouring procedures. As an all-inclusive platform, the VentX Console is designed to optimize every step of the body sculpting procedure. Contained in one easy-to-maneuver unit, it requires only a minimum amount of space - and produces maximum results. The VentX Console is composed of the following main components: VentX Console Upright:

VentX Console Base:

•

Infiltration Volume Display and Bag Hook

•

Infiltration Pump

•

Suction Filter Housing

•

Infiltration Controls and Displays

•

Vacuum Gauge Display

•

Vacuum Pump

•

Canister/Utility Rack

•

Vacuum Controls and Displays

•

Footswitches (2)

The VASERlipo™ System includes the VentX Infiltration and Aspiration Console, and the VASER® Amplifier.

1.0

Safety

Warnings, Cautions, Notices, and Symbols Warning: Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury. Caution: Indicates a potentially hazardous situation that, if not avoided, could result in minor or moderate injury. Notice:

Indicates a potential hazard that may result in product damage.

BS EN ISO 15223-1: 2016 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements Symbol

Symbol Ref. No.

Symbol Title

5.1.1

Manufacturer

5.1.2

Authorized representative in the European Community

Additional Information The date of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol. Additional reference ISO 7000-3082.

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T h e Ve n t X ® C o n s o l e

BS EN ISO 15223-1: 2016 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements Symbol

Symbol Ref. No.

Symbol Title

Additional Information

Date of manufacture

This symbol can be filled or unfilled. If filled, the date of manufacture as well as the name and address of the manufacturer can be combined in one symbol. Additional reference ISO 7000-2497.

5.1.4

Use-by date

Synonym for “use-by date” is “use by.” Also called “expiration date”. Additional reference ISO 7000-2507.

5.1.5

Batch code

Synonyms for “batch code” are “lot number” and “batch number.” Additional reference ISO 7000-2492.

5.1.6

Catalogue number

Synonyms for “catalogue number” are “reference number” and “reorder number.” Additional reference ISO 7000-2493.

5.1.7

Serial number

Additional reference ISO 7000-2498.

5.2.4

Sterilized using irradiation

Additional reference ISO 7000-2502.

5.2.8

This symbol may also mean “Do not use Do not use if package if the product sterile barrier system or its is damaged packaging is compromised.” Additional reference ISO 7000-2506.

5.3.1

Fragile, handle with care

Additional reference ISO 7000-0621.

5.3.4

Keep dry

Additional reference ISO 7000-0626.

5.1.3

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Infiltration, Aspiration and Accessories User’s Guide

BS EN ISO 15223-1: 2016 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements Symbol

Symbol Ref. No.

Symbol Title

Additional Information

5.3.7

Temperature limit

Additional reference ISO 7000-0632.

5.3.8

Humidity limitation

Additional reference ISO 7000-2620

5.3.9

Atmospheric pressure limitation

Additional reference ISO 7000-2621.

5.4.2

Do not re-use

Synonyms for “Do not re-use” are “single use” and “use only once.” Additional reference ISO 7000-1051.

5.4.3

Consult instructions for use

Synonym for “Consult instructions for use” is “Consult operating instructions.” Additional reference ISO 7000-1641.

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IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

Additional Information

0033

Suction

To indicate the generation of an air current by the use of suction, for example the removal of dust or particulate matter, or lifting of light materials by suction.

0623

This way up

To indicate correct upright position of the transport package. Additional reference IEC 7000-0623.

Zero-point Motion

Scale Tare Button: press to “zero” reference the display. To identify the control for adjusting the zero point, for example on a measuring instrument.

“ON” (power)

To indicate connection to the mains, at least for mains switches, or their positions, and all those cases where safety is involved. Additional reference IEC 60417-5007 (2002-10).

5008

“OFF” (power)

To indicate disconnection from the mains, at least for main switches, or their positions, and all those cases where safety is involved. Additional reference IEC 60417-5008 (2002-10).

5016

Fuse

To identify fuse (fuse boxes) or their location Additional reference IEC 60417-5016 (2002-10).

Protective earth; protective ground

To identify any terminal this is intended for connection to an external conductor for protection against electric shock in case of fault, or the terminal of a protective earth (ground) electrode. Additional reference IEC 60417-5019 (2006-08).

Equipotentiality

To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding. Additional reference IEC 60417-5021 (2002-10).

0940

5007

5019

5021

4

Symbol Title

Infiltration, Aspiration and Accessories User’s Guide

IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

Symbol Title

Additional Information

Movement in both directions

Specific to Peristaltic Pump Direction To indicate that a control or an object, by means of a control, can be moved in both the indicated directions. Additional reference IEC 60417-5023 (2002-10)

5032

Alternating current

To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. Additional reference IEC 60417-5032 (2002-10).

5114

Foot switch

To identify a foot switch or the connection for a foot switch. Additional reference IEC 60417-5114 (2002-10)

5334

Type BF applied part

To identify a type BF part complying with IEC 60601-1. Additional reference IEC 60417-5334 (2002-10) Note 1 – B = Body. Note 2 – F = Floating applied part.

5448

Input/output

Ultrasound footswitch control. To identify a combined input/output connector or mode.

Power Plug

Power Plug: auxiliary outlet IEC 320 Sockets. To identify connection means (e.g. plug or cord) to the power source (mains) or to identify the storage place for the connecting means.

Door, open

To indicate that for the correct operation of a process the marked item, for instance a door, lid or flap, must be open. This symbol may also be used to identify the control for opening the door, lid or flap.

5023

5534

5624

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T h e Ve n t X ® C o n s o l e

IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

5713

Symbol Title Variation of ultrasound energy

Additional Information To identify the control or the indicator to increase or decrease the emitted ultrasound energy, typically in conjunction with footswitch control. Vacuum Level Control

ISO 7000-1364

Variability, for vacuum control

ISO 7000-2164

Variability, for infiltration rate, variability in steps

 he controlled quantity increases linearly T with clockwise rotation.

Infiltration Rate Control

- The controlled quantity increases in steps with clockwise rotation.

Stacking limit

To indicate that the items shall not be vertically stacked, either because of the nature of the transport packaging or because of the nature of the items themselves.

Packaging unit

To indicate the number of pieces in the package. Additional reference ISO 7000-2794 (2009-02) Note – A number is inserted in the symbol to indicate the number of parts in the package.

ISO 7010-W001 (2011-06)

General warning sign

To signify a general warning. Note - This safety sign cannot be used on its own and requires a supplementary sign to give further information about the hazard. IEC TR 60878 note: On medical equipment, this safety sign shall only be used if there is no other safety sign for the corresponding hazard. If possible, the hazard or the appropriate precaution should be indicated.

ISO 7010-W005 (2011-06)

Warning: Nonionizing radiation

To warn of non-ionizing radiation.

ISO 7000-2402 (2011-06)

ISO 7000-2794 (2011-06)

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Infiltration, Aspiration and Accessories User’s Guide

IEC TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice Symbol

Symbol Ref. No.

Symbol Title

ISO 7010-W012 (2011-06)

Warning: electricity

To warn of electricity.

ISO 7010

Warning: Pinch Point Hazard

Peristaltic Pump – Danger of crushing hand

Suction bottle

To indicate a reference to a suction bottle or suction bottle control.

60601-2-18:2009

Additional Information

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BS EN 50419:2006 Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE) Symbol

Symbol Title

WEEE wheeled bin

Additional Information This product contains electrical and electronic components that may contain materials which, if disposed with general waste, could be damaging to the environment. Residents of the European Union must follow specific disposal or recycling instructions for this product. Residents outside the European Union must dispose or recycle this product in accordance with local laws or regulations that apply.

Other Marks and Symbols Symbol

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Symbol Description

Additional Information

Push to open

Based on IEC 60878-5624 and 0096

Foot Pedal Interconnect

For Ultrasound Footswitch, based on IEC 60878-5712, 5448, and 5713.

Infiltration

To indicate water or water-base fluid

Suction Footswitch Connector

Based on IEC 60878-5114 and 60601-2-18 suction bottle.

Infiltration Footswitch Connection

Based on IEC 60878-5114

Universal Recycling Symbol U+2672

Recycling Symbol followed by the number or description of the recyclable material to indicate that the marked item or its material is part of a recovery or recycling process.

Infiltration, Aspiration and Accessories User’s Guide

Other Marks and Symbols Symbol

Symbol Description

Additional Information

For U.S. Only: Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician or licensed health care professional.

USA Code of Federal Regulations 21 CFR Part 801 § 801.109(b)(1)

European Conformity mark Notified Bodies: DEKRA (0344) TUV Rheinland (0197)

The product conforms to European Medical Directive 93/42/EEC and meets applicable health, safety and environmental requirements. If the mark is accompanied by a number, conformity is verified by the indicated notified body.

ETL Product Listing mark

Represents compliance to North American product safety standards as determined through independent testing and certification by Intertek Group plc.

MADE IN USA

Country of origin symbol

Contains or presence of phthalate: bis (2-ethylhexyl) phthalate (DEHP)

ESD Warning

This symbol is derived from ISO 7000-2725 (“Contains or presence of”). REF EN 15986:2011 Symbol for use in the labeling of medical devices – Requirements for labeling of medical devices containing phthalates.

MIL-STD-129 ESD Label Standard

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Solta Medical has determined that the VentX/VASERlipo System has been shown to comply with the applicable technical standards if no unauthorized change is made in the equipment and if the equipment is properly maintained and operated. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Contraindications Use of this device is contraindicated for patients with chronic medical conditions, such as obesity, diabetes, blood clotting disorders, heart, lung, or circulatory system disease, or vascular problems, including common circulation problems and coagulation problems with medication. The following conditions may affect the safety or effectiveness of this device: presence of collagen, scarring, or connective tissue disorders; presence of stretch marks or potential for stretch mark formation; Lupus Erythematosus; endocrine disorders; pregnancy or the possibility of pregnancy; or other active diseases that may affect the procedure outcome or increase risk.

Operator Warnings Warning:

This device will not, in and of itself, produce significant weight reduction.

Warning:

 he volume of blood loss and endogenous body fluid loss may adversely affect intra and/ T or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.

Warning:

The VentX/VASERlipo System is intended for use by healthcare professionals only.

Warning:

 he VentX/VASERlipo System may cause radio interference or may disrupt the operation T of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the VentX/VASERlipo System or shielding the location.

Warning: It is essential the VentX/VASERlipo System performs per the operators input settings. Placing the system in areas where intense electromagnetic disturbances could be present may affect the input settings and could possibility result in patient harm. Warning: The use of accessories, transducers and cables other than those specified or provided Solta could result in increased electromagnetic emissions or decreased electromagnetic immunity of the VentX/VASERlipo System and result in improper operation. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VentX/VASERlipo System, including cables specified by Solta. Otherwise, degradation of the performance of this equipment could result. Warning: The VentX/VASERlipo System should not be used adjacent to or stacked with other (nonSolta Medical) equipment. If adjacent or stacked use is necessary, the VentX/VASERlipo System should be observed to verify normal operation in the configuration in which it will be used. As part of normal operation, the following Solta Systems can be used at the same time in a stacking configuration. The VASER Pro Amplifier System, the VentX System, and the PowerX System have been tested in a stacking configuration and comply with the applicable emissions and immunity requirements specified in IEC 60601-1-2:2014 Warning: Do not block or cover the ventilation openings on the VentX/VASERlipo System. Overheating could occur, causing decreased functionality of the system.

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Infiltration, Aspiration and Accessories User’s Guide

Warning:

Suction tubing and collection canisters are for single patient use only. DO NOT REUSE.

Warning:

This device is not suited for use in and around a MRI environment.

Warning:

Suction and infiltration tubing are provided sterile. Do not use if the package is damaged.

Warning:

 onnecting electrical equipment to the auxiliary outlets leads to creating an ME (Medical C Equipment) System and the result can be a reduced level of safety. If connecting equipment that is not part of the ME system, have a trained service person evaluate the ME system to ensure safety leakage currents are maintained per IEC 60601-1.

Warning:

 o avoid the risk of electric shock, this equipment must only be connected to a supply mains T with protective earth.

Warning:

 se of this device is limited to those physicians who, by means of formal professional U training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty.

Operator Cautions Caution: The safe and effective use of this medical device depends to a large degree on factors solely under the control of the operator. It is important that all operators of this surgical system read, understand, and follow the operating instructions supplied with this equipment. Caution: U.S. Federal Law restricts this device to sale to or on the order of a physician. Caution: The VentX/VASERlipo System is intended to be used in a Professional healthcare facility environment (e.g.; hospitals or outpatient clinical surgical facility). It does not include areas where there are sources of intense electromagnetic disturbances, such as a RF shielded room of magnetic resonance imaging, or in operating rooms near active HF surgical equipment. Caution: This device is designed to contour the body by removing localized deposits of excess fat through small incisions. Caution:  If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation. Caution:  Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. Caution: The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. Caution: All reusable components of the device must be sterilized and all disposable components replaced before using the device on another patient. Note: The Emission characteristics of this equipment make is suitable for the use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential/domestic environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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T h e Ve n t X ® C o n s o l e

Indications for Use The VentX Console is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX Console is designed to operate with the VASER Amplifier or as a stand-alone system. The VASERlipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for aesthetic body contouring (modification of the anatomy). The VASERlipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: √

Neurosurgery

√

Orthopedic Surgery

√

Gastrointestinal and Affiliated Organ Surgery

√

Gynecologic Surgery

√

Urologic Surgery

√

Thoracic Surgery

√

Plastic and Reconstructive Surgery

√

Laparoscopic Surgery

√

General Surgery

2.0 Equipment Description Equipment List As an all-inclusive platform for infiltration and aspiration, the VentX Console is designed to optimize every step of the body sculpting procedure. Contained in one easy-to-maneuver unit, it requires only a minimum amount of space - and produces maximum results. The VentX Console is composed of the following main components: VentX Console Upright: •

Infiltration Volume Display and IV Bag Hook

•

Suction Filter Housing

•

Vacuum Gauge Display

•

Canister/Utility Rack

VentX Console Base: •

Infiltration Pump

•

Infiltration Controls and Displays

•

Vacuum Pump

•

Vacuum Controls and Displays

•

Footswitches (2)

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Infiltration, Aspiration and Accessories User’s Guide

Infiltration Volume Display and IV Bag Hook: Simplifies fluid tracking by measuring infiltrate volume. It has the ability to display volumes up to 4500mL. Suction Filter Housing: Houses the filter in an easy to access and read, yet aesthetically enhancing location for trapping any overflowing fat and fluids. Vacuum Gauge Display (upper): Displays the vacuum level on the upper part of the VentX Console to provide more visibility to the end user. There is also another gauge located at the base/lower part of the VentX Console for better control when adjusting specific vacuum levels. Canister/Utility Rack: This universal canister rack allows for up to four (4) 1,250 ml VentX Suction Canisters and most other industry-standard fat collection canisters. Other utilities and accessories can also be attached using the adaptable sliding slots. Infiltration Pump: Provides reversible, smooth, and adjustable infiltration. Infiltration Controls and Displays: A control for variable flow rates ranging from 50 mL per minute up to 550 mL per minute to customize infiltration rates for each patient and treatment area. A digital display clearly indicates the chosen flow rate. Vacuum Pump: Provides quiet, efficient removal of fatty tissue with precise vacuum control. The vacuum pump is positioned inside the bottom part of the unit. Vacuum Controls and Displays: There are three vacuum modes on the lower part of the VentX Console that are controlled by the Vacuum Mode Button: suction (S), ambient (A) or occlude (press and hold). The 4-turn vacuum level control allows the operator to adjust the vacuum level desired for fat removal and delicacy. These controls and displays are located on the lower part of the Console for better control when adjusting specific vacuum levels as well as on the upper to provide more visibility. Footswitches (2): Infiltration and aspiration can be activated electronically for easy control and precision utilizing an ergonomic, user-friendly design.

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T h e Ve n t X ® C o n s o l e

Figure 1. VentX Full System 1.

3.

VentX Console Upright: 1.

4.

Infiltration Volume Display

2. 2. IV Bag Hook 3. Suction Filter Housing

5.

4. Vacuum Gauge Display 5. Canister/Utility Rack

10.

VentX Console Base: 6.

9.

6. Infiltration Pump (not visible) 7. Infiltration Controls and Displays

7.

8. Vacuum Pump (not visible) 9. Vacuum Controls and Displays

8.

14

10. VASER® Amplifier (if applicable)

Infiltration, Aspiration and Accessories User’s Guide

Using the VentX Console and Accessories with the VASER® Amplifier The VASER Amplifier can be placed directly on top of the VentX Console so that both control panels are toward the front. There will be an additional VASER Back Cover included to hide cords and the VASER Power Cord will connect to the auxiliary power receptacle on the VentX Console (Figure 5).

Figure 2. VentX Upright 6. 3. 4.

1.

2.

1.

Suction Filter Housing

2. Vacuum Gauge Display (upper)

5.

3. Infiltration Volume Display (mL) 4. Volume Reset Button 5. IV Bag Hook 6. Wireless Footswitch Receiver

7.

(if applicable) 7. Canister/Utility Rack 8. VentX Console Upright

8.

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T h e Ve n t X ® C o n s o l e

Figure 3. VentX Console Display

4. 7. 2.

1.

5.

3. 1. 2. 3. 4.

Main AC power I/O switch Vacuum Level Control (in Hg) Vacuum Gauge Display (lower) Mode Indicator (suction/ambient/occlude)

6.

5. Vacuum Mode Reset Button 6. Infiltration Rate Indicator 7. Infiltration Rate Control

Figure 4. Back of VentX (Panel Closed) 1.

1.

Suction Filter Housing

2. Suction Filter (connection to canisters)

2.

3. Adjustable Canister/Utility Rack

4.

3. 4. Adjustment Knob for Canister/Utility rack (not visible) 5. Peristaltic Infiltration Pumphead 6. Infiltration Forward/Reverse Switch (not visible)

5. 6.

7. VentX Cooling Vents

7.

8. Access Panel (closed) 9.

8.

Power Entry Module

10. Non-Locking Casters (front)

10.

11.

9. 11.

16

Locking Casters (rear)

Infiltration, Aspiration and Accessories User’s Guide

Figure 5. Back of VentX (Panel Open)

7.

6. 1.

5.

2.

4.

a.

b.

c.

3.

1. 2. 3. 4.

Console Handles (Use to push only. Do not use to lift Console.) Access Panel (open) Main Power Cord Receptacles Footswitch Receptacles a. Suction (left) b. Infiltration (middle) c. VASER - if applicable (right)

5. Auxiliary Power Cord Receptacle(s) 6. VASER Back Cover 7. VentX Fuses

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