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Acessa

ProVu System User’s Guide

PL-01-0040

CO 20-131 Revision: C

20.

Glossary of Symbols and Product Graphics

20.1.

Symbols

Symbol

Standard

Symbol

Reference

Number

Symbol Title

/Description

Symbol

Standard

Symbol

Reference

Number

Symbol Title/ Description

EN 50419

Recycle: Electronic

Equipment

/ Do Not

Throw Away.

IEC 60417-

5032:2002

Alternating Current

/ To indicate on

the rating plate that the equipment is

suitable for alternating current only;

to identify relevant terminals.

US 21 CFR

801.109

Prescription Only

Device restricted to use

by or on the order of a

physician.

IEC 60417-

5140:2003

Radio Frequency

/To indicate

generally elevated, potentially

hazardous, levels of nonionizing

radiation, or to indicate equipment or

systems e.g. in the medical electrical

area that include RF transmitters or

that intentionally apply RF

electromagnetic energy for diagnosis

or treatment.

IEC 60601-

1:2012

Table D.1,

Symbol 20

BF Type Applied Part

To identify a type BF

applied part complying

with IEC 60601-1.

IEC 60417-

5021:2002

Potential Equalization Terminal

/ 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.

IEC 60417-

5331: 2002

Not Anesthetic Proofed

/ Not suitable for use

with flammable

anaesthetics!

IEC 60601-

1:2012

Table D.2,

Symbol 10

Follow Instructions for Use

/ Refer

to instruction manual/booklet.

IEC 60417 -

5036

Warning: Electricity

Warning dangerous

voltage.

ISO 15223-

1:2016

5.1.3

Date of Manufacture

/ Indicates the

date when the medical device was

manufactured.

ISO 15223-

1:2016

5.4.2

Single Use only

Indicates medical device

that is intended for one

use, or for use on a

single patient during a

single procedure.

IEC 60417-

5016: 2002

Fuse Rating

/ To identify fuse boxes

or their location.

ISO 15223-

1:2016

5.1.5

Lot Identification

Indicates the

manufacturer's batch

code so that the batch

or lot can be identified.

ISO 15223-

1:2016

5.1.6

Catalogue or Model Number

Indicates the manufacturer's

catalogue number so that the

medical device can be identified.

ISO 15223-1:

2016

5.1.7

Serial Number

Indicates

manufacturer's serial

number so specific

medical device can be

identified.

IEC 60417-

505: 2002

Monitor

/ To identify the terminals

and controls for a television monitor.

USB

Implementors

Forum, Inc.

USB Port

/External

interface to support

data transfer to

peripheral devices.

ISO 15223-

1:2016

5.1.4

Use by

/ Indicates the date after

which the medical device is not to be

used (YYYY-MM-DD).

50C

-10C

ISO 15223-1,

Clause 5.3.8

Storage temperature

range

/ Indicates range

of temperature the

medical device can be

safely exposed.

ISO 15223-

1, Clause

5.3.7

Storage humidity range

Indicates

range of humidity to which the

medical device can be safely exposed.

Содержание Acessa ProVu

Страница 1: ...Acessa ProVu System User s Guide PL 01 0040 CO 20 131 Revision C 1 USER S GUIDE Release Date 2 5 2021...

Страница 2: ...eration of System During Coag 19 10 13 After the Procedure 19 10 14 Shutting Down the System 19 11 Special Considerations General Ablation Procedures 20 11 1 Highly Vascularized Tissue 20 11 2 One or...

Страница 3: ...ling 31 17 Care and Maintenance 31 17 1 Software Upgrades and Installation 31 17 2 Maintenance 31 17 3 Cleaning and Disinfecting the Console 31 17 4 Calibration Verification 31 18 Specifications 31 18...

Страница 4: ...he ablation throughout the procedure The Acessa ProVu System must be used under laparoscopic ultrasound guidance The basic function of ultrasound is to acquire ultrasound echo data and to display the...

Страница 5: ...Acessa ProVu System User s Guide PL 01 0040 CO 20 131 Revision C 4...

Страница 6: ...the patient may result in burns Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts such as tissue smoke plume and aerosols protective eyewear filtration mask...

Страница 7: ...ses within body cavities or originate in surgical drapes tracheal tubes or other materials ASPIRATE fluid from the area before activating the instrument Conductive fluids e g blood or saline in direct...

Страница 8: ...f monopolar electrosurgery particularly in the prevention of burns Follow directions and recommended practices for the preparation placement surveillance removal and use of the Pads Use with the syste...

Страница 9: ...communications equipment can affect the Acessa ProVu Systemfunctionality Do not expose the Handpiece or Transducer with Sensorto a high magnetic field such as a Magnetic Resonance Imaging MRI scanner...

Страница 10: ...use Clean and disinfect the Pad Cable in accordance with the recommended process in the Instructions for Use accompanying the cable Ensure that the Pad cable interconnections are clean and dry prior t...

Страница 11: ...r Connector Accepts the connector from either the Table Top Field Generator or Planar Field Generator K Handpiece Connector Accepts either end of the Handpiece Cable L Return Pad Connector Accepts the...

Страница 12: ...ed R is connected to the wye marked R and similarly L to L for the other pad Affix the Return Pads to the patient per the Pad IFU PL 01 0015 Consult Pads Instruction for Use for prep of patient and pr...

Страница 13: ...ssories can be connected before or after the systemhas been powered ON except TTFG cable and power cord which must be connected prior to system power ON 9 4 Energizing The System Place the power switc...

Страница 14: ...atient s feet surgeon is on the patient s right The left side shows Guidance and the right side shows the ultrasound The screen layout is most efficient if the ultrasound side is closest to the laparo...

Страница 15: ...evision C 14 10 3 User Interface Upper Left Deployment Ablation Coag Center Top Expected Ablation Size Upper Right Ultrasound Settings Center Middle Proximity Meter Lower Left Menu Selections Lower Ce...

Страница 16: ...tions are 3cm 4cm 5cm 6cm 7cm 8cm and 9cm Frequency The Frequency penetration resolution options are 5MHz 6MHz 9MHz and 12MHz Gain The Gain brightness options are 0 100 in 1 increments Focus The Focus...

Страница 17: ...al to the level setting The user slowly withdraws the Handpiece while visually monitoring the coag laparoscopically adjusting level setting as necessary to achieve optimal results Turn off RF power wh...

Страница 18: ...ot be taken using them If the Handpiece is inserted out of plane do not use the meter reference the 2D display Handpiece ultrasound Target Zone The software provides a prediction of the Handpiece s pa...

Страница 19: ...advance the Handpiece until the tip is at the serosa of the uterus viewed on the laparoscopic monitor After the tip penetrates the serosa view image on the ultrasound monitor Corrections to the path...

Страница 20: ...e last setting chosen The Handpiece tip should be allowed to cool for 60 seconds after the ablation has stopped prior to removing it from the target tissue When ready to Coag turn the RF energy on by...

Страница 21: ...emperature for stated target time for the last deployment stage to allow for complete tissue destruction If a fibroid is densely concentrated with calcium to the degree that there is abnormal resistan...

Страница 22: ...tatus was gravida 2 8 2 0 and para 2 1 1 6 At the time of screening 81 of the subjects reported having regular menstrual cycles and 77 reported having heavy to very heavy bleeding volume Nearly 85 of...

Страница 23: ...nths Subjects were required to have a normal coagulation profile a normal Pap smear and pass a preoperative health examination American Society of Anesthesiologists ASA physical status I III Subjects...

Страница 24: ...In cases where deployment of the electrode array was performed the array was deployed so that the electrode tips were at least 1 cm away from the fibroid margin in all three planes Laparoscopic ultra...

Страница 25: ...at 12 months post treatment Subject Disposition at 12 Months Post Treatment n Total Treated 137 100 Evaluable for Menstrual Blood Loss Using Alkaline Hematin 124 90 5 Withdrew prior to 12 months 2 Lo...

Страница 26: ...8 Efficacy Menstrual Blood Flow as Assessed by Alkaline Hematin AH In the evaluable subjects n 124 the mean reduction in menstrual blood flow at 12 months post treatment was 103 6 ml One hundred four...

Страница 27: ...oncern Activities Energy Mood Control Self Consciousness and Sexual Function Scores at 3 6 12 24 and 36 Months Post Treatment 16 25 38 44 60 50 40 30 20 10 0 Month 3 Month 12 Change From Baseline Uter...

Страница 28: ...ecame pregnant in the second year of follow up One pregnancy resulted in a spontaneous abortion in the first trimester one progressed normally resulting in a vaginal delivery and two subjects had a C...

Страница 29: ...Sites 14 sites in the United States and Canada enrolled participants in the study 14 4 Total Number of Enrolled Subjects and Follow up Rate A total of 110 participants were enrolled Five 5 subjects w...

Страница 30: ...ts who participated in that follow up visit For the acute serious complication rate the null hypothesis was that the acute serious complication rate for the Acessa procedure is no different than the o...

Страница 31: ...n mild intra operative bleeding transient urinary retention or urinary tract infection adhesion formation post procedural discomfort cramping pelvic pain and transient amenorrhea The risk of skin burn...

Страница 32: ...ld be given reasonable care and be kept clean and sanitary To clean the Console Foot Pedal and Field Generators wipe down the devices with a 70 isopropyl alcohol wipe Clean surfaces until all visible...

Страница 33: ...ad Port Transducer Port Transducer Sensor Port Field Generator Port USB Port Video Port HDMI Power Entry Module with internal fuses Protection Class I Type BF Applied Part Rated for ordinary Continuou...

Страница 34: ...5 0 5kV 1 kV for line to line 0 5kV 1 kV 2kV for line to ground 0 5kV 1kV line to line 0 5kV 1kV 2kV line to ground Mains power quality should be that of a typical commercial or hospital environment...

Страница 35: ...e level above the system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the system b Over the...

Страница 36: ...ation lower levels may be more effective Watts of Power vs Rload Ablate Modes Note The unit is limited at low load impedances by maximum available current and is limited at high load impedances by max...

Страница 37: ...d Errors The system detects and displays fault and error conditions A fault is a correctible condition that produces an Alert screen while an error is irreversible and requires system reboot to clear...

Страница 38: ...unplugged Yes 1 Press Acknowledge Check Button 2 Check Pad or cable connection 3 If connections are good replace Cable 4 If Cable was good replace Pad Fewer than 4 valid functioning Handpiece TCs Han...

Страница 39: ...ds and then release it 2 Then turn off the rear power switch 3 Wait at least 10 seconds and then restart the Console 4 If it happens again call Acessa Health with failure number Instrument encounters...

Страница 40: ...Not suitable for use with flammable anaesthetics IEC 60601 1 2012 Table D 2 Symbol 10 Follow Instructions for Use Refer to instruction manual booklet IEC 60417 5036 Warning Electricity Warning danger...

Страница 41: ...needs to be protected from moisture IP2X IEC 60529 IP2X Protection against approach by fingers ISO 60601 2 1 2009 IEC 1193 06 Figure 201 102 2009 HF Isolated Patient Circuit High Frequency Isolate Pat...

Страница 42: ...ring or unauthorized servicing may void any manufacturer s warranties LIMITATIONS and OBLIGATIONS THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER EXPRESS WARRANTIES AND IMPLIED WARRANT...

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