Manual do Usuário BP-150 (ESU-150W) ingles

7/28/2019 Manual do Usurio BP-150 (ESU-150W) ingles

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BP-150ELECTROSURGICAL

USER MANUAL

Transmai Equipamentos Mdicos Hospitalares Ltda.

Av. Maria Estela, 33 - Jardim Maria Estela

CEP: 04180-010 - So Paulo SP - Brasil

+ 55 11 2335.1000

Fax extension 210


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I N D E X

Chapter 1 Introduction

Note of property ............................................................................................ . 3General precautions ........................................................................... . . 3

Operational precautions . . 3

Notices . 4

Basic care resume . . . 5

Symbology ........................................................................................................ 5

Danger ........................................................ . 6

Chapter 2 Recognizing Equipment

General information . . 8

Packing and transport . . 13

Selection and use of accessories .... . . 14

Accessories accompanying Electrosurgical BP-150 . . 15

Accessories Description .. . . 16

Biocompatibility . . . 18

Identifying front panel ................................................................... . . 19

Identifying rear panel .................................................................................... . 20

Knowing general functioning ... . 20

Chapter 3 Use Instructions

Instructions for use .. 23

Recommendations during surgical operation ... . 24

Remarks ............. 25

Chapter 4 Care and Maintenance

Cleaning .. . . 27

General care and sterilization ............................................................... . . 27

Interferences . . . . 29

Maintenance ...................................................................................................... 30

Inspection and preventive maintenance . 30Problems and solutions ........................................................................... . . 31

Conclusion .. . . 32

Technical specification ........................................................................... . . 32

Bibliography . 34

Guarantee 35

Certificate of Guarantee .......................................................................... . . 36


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Chapter 1

INTRODUCTION


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Chapter1 Introduction_______________________________________________________

NOTE OF PROPERTY

All information contained in this document is property of Transmai and no part of the whole

of this publication may be duplicated without permission in writing from Transmai. Until thedate of this publication all efforts were directed to make possible the most accurate

information in this manual.

Transmai reserves the rights of making any changes when necessary in handbook or product

without prior notice, aiming at improvement of product.

GENERAL PRECAUTIONS

ELECTRIC SHOCK RISK: Do not remove equipment lid. Besides dangerous inner

tensions, there exists the risk of damage to patient protection system. No inner part of

equipment could be repaired without knowledge, technical documentation and specific

training carried out by engineering section of the company.

This equipment must be used by qualified staff. Operator must be acquainted with

information contained in this manual before using this electrosurgical.

OPERATIONAL PRECAUTIONS

Safe and properly use of electro surgery depends so much on factors only under control of

operator.

Really important is that operating instructions coming with or any other equipment be read,

understood and followed judiciously.

Electro surgery uses RF (radio frequency) to cut and coagulate tissues and therefore there will

always be higher or lower intensity of sparks on the place, depending on power used.

Consequently it is inherently dangerous its use near anesthetics, fluids or flammable objects.

Precautions must be taken in the sense of restricting use of flammable material in places of

electro surgery, being them in form of anesthetic skin conditioners or those naturally

produced within cavities of body.

Electro surgery units must be carefully used when in presence of internal or external

pacemaker, since interference of electro surgery current may make them enter into

asynchronous mode or could block them completely. When doubts turn out, consultpacemaker manufacturer and/or cardiology department.

During surgery, do not let patient be in contact directly with ground connected metallic

objects, such as auxiliary table for instruments, surgery table structure, etc. Diverse probes

and electrodes used in monitoring devices of images and stimulation may provide way for

high frequency current, independently of their 60Hz isolation or whether operated by battery.

Risks of electro surgery burns can be reduced by placing these electrodes and probes as far as

possible from surgery place and neutral plate.

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Chapter 1 Introduction______________________________________________________

Contacts skin to skin, like arm to patient trunk for example, can be avoided placing a 10cm

piece dry bandage and by keeping always attention to points like this one, of easy

accumulation of liquids after asepsis of patient.

Before using active accessories, disposables and neutral plate, read instructions, care andprecautions which come with them.

Note: Keep active accessories far from patient, if they are not in use. Accessories

labeled as disposable, are of one way use. Do not use or sterilize them again.

When using coagulator vacuum cleaner, make sure that outer part of suction tube is free of

blood and mucus. Cleaning fault of suction tube could open way to conduction of electric

current, which may cause burns accidentally.

Note: To avoid possibility of burns to user, turn off scalpel always before flexing or

giving new form to suction tube. Do not dip tube into conducting liquids.

NOTICES

NOTICE 1: Electrical hazardous outlet. This equipment must be operated by qualified

professional only.

NOTICE 2: Check pens and neutral plate cords constantly. (KEEP ALWAYS A SPARE SET).

NOTICE 3: Activation tone is an important safety characteristic. Do not let it inaudible.

NOTICE 4: Check always perfect mechanical and electric contacts among

EQUIPMENTCORD/NEUTRAL PLATE AND PATIENT, this is of

fundamental importance for protection and prevention against accidents.

NOTICE 5: Put always conductive paste between neutral plate and patient and keep its whole

surface in firm contact with patient.

NOTICE 6: Potential conditions of risk may occur when similar accessories are used, mainly

monopole pens and tweezers.

NOTICE 7: Check always position of selector key: Cut, Blend 1, Blend 2 and Blend 3;

monopole or bipolar as one of these functions always inhibits any other.

NOTICE 8: Power cord has to be connected to socket with ground, no adapter plugs or

extensions must be used.

NOTICE 9: Despite our neutral plate has bigger area than those required by standards, NEVER

reduce size or contact area of neutral plate in order to ensure safety to patient.

NOTICE 10: Fails on local electric network or in scalpel may cause undesired increase or

decrease of power outlet.

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Chapter1- Introduction_______________________________________________________

NOTICE 11: While working, electrosurgical of high frequency may wrongly influence upon

other

electronic equipments.

NOTICE 12: Electrical hazard: Do not remove upper lld of equipment. Call our technicalservices authorized network.

BASIC CARE RESUME

TransmaiElectrosurgical BP-150, despite of its sophisticated technology, having three types

of electric current and several other resources, has an extremely simple handling, but working

together with other equipment may complicate its operation and every kind of care should be

taken in order to avoid accidents to both patient and user.

SYMBOLOGY

- Attention: Outlets which produce physiologic effects to patient and

user

- Risk of electric shock/dangerous tension

- CF type part / Outlet protected against defibrillator discharge

- Equipment with isolated outletF

- Neat cut

- Blend 1

-Blend 2

- Blend 3

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Chapter1- Introduction_______________________________________________________

- Fragile content Handle with care

- Maximum piling

- Right position for storing and transport (This side up)

- Should be transported and stored away from rain or high humidity

- Top temperature for transport and storing

- Case should not be exposed to direct sunlight (protected against sunlight)

- Maximum weight upon case during transport and storing

-20C

75C

3

17kg

DANGER

EXPLOSION HAZARD

DO NOT USE NEAR FLAMMABLE GASES AND ANESTHETICS

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Chapter 2

RECOGNIZING EQUIPMENT


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Chapter 2- Recognizing equipment______________________________________________

GENERAL INFORMATION

FUNCTION AND APPLICATION OF ELETROSURGICAL EQUIPMENT

Electrosurgical equipment is a generator of high frequency currents which are applied to makesurgical incisions, destroying cells of tissues by means of high frequency current. There is no

need of physical pressure, procedures are quicker, accurate and controlled. The aim of this

technique is to explode tissue cells by heating their intern liquids. Thence rupture occurs

and cutting effect of tissue is obtained.

Essentially, equipment generate outlets of three kinds, one that makes cuts of tissues, a second

one which makes coagulation of blood vessels and a third one combining cut and coagulation

(called blend) which makes possible cut on tissues and coagulation of vessels at the same

time.

As described above, for every application we have the respective operational mode whichpresents the best results in application and desired surgical effects.

Following items describe electro surgery principles, differences between electrosurgical

equipments, electricity effects on tissues, operating modes, monopole surgery, bipolar surgery

and surgical effects.

ELECTROSURGERY PRINCIPLE:

In electrosurgical equipment, electric power in inner main source is turned into an electric

current of radio frequency. This high frequency current flows through one cord till an active

electrode (pen). At contact point with tissue it occurs high concentration of energy within

small area, which produces desired electronic effect (cut tissue or carry out hemostasis). Thiscurrent passes through patient down to neutral plate, which has big area of contact to patient,

reducing current concentration (avoiding burns). Plate in connection with scalpel, circuit then

is closed.

High frequency is used, because frequency under 100kHz will stimulate muscles and nerves.

Too low frequency would electrocute patient. Frequencies above 4MHz could perfectly be

used in electro surgery, but electric phenomena like capacitive, inductive reactances and skin

effect become significant, making it difficult the use of cords for these applications.

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Chapter 2- Recognizing equipment_____________________________________________

DIFERENCE BETWEEN ISOLATED AND GROUND REFERRED ELECTROSURGICALS:

In ground referred electrosurgical, electric current passes from active electrode through

patient and returns through neutral plate, however it also could return through any grounded

object.

Isolated electrosurgical are safer than ground referred equipments, because current

theoretically returns by neutral plate to the negative part of inner isolator transformer of

equipment. If neutral plate is not duly connected, this current will not find a low resistance

way through other grounded objects. Practically, in isolated electrosurgical small escape

current will freely circulate through this alternative way.

Alternative ways are opened when patient leans against grounded objects. If these objects

have small contact area, this will provoke burns to patient, much more serious with ground

referred than with isolated electrosurgical.

EFFECTS OF ELECTRICITY ON TISSUES:

It is notorious that low frequencies cause several problems to patient; therefore

Electrosurgical BP-150 operates with frequencies four times above the range in which

stimuli to muscles and nerves do not happen.

Intensity and distribution of heat through tissues may be changed by varying operation mode,

cut, blend and coagulation. Electrosurgical provides adequate power for every resistance in

safe and efficient way. It should always be observed that different tissues have different

resistances and conductivities, and that he position of neutral plate in relation with active

electrode and contact with patient will also interfere on more effective power values.

Tissue Typical Resistance (Ohms)Blood 160

Muscle, Heart, Kidney 200

Liver, Spleen, Pancreas 300

Lung 1000

Adipose Tissue 3300

Tissue Resistance Table for Frequencies from 300kHz to 3MHz

ELECTROSURGICAL OPERATION MODES:

Cut: Resection or dissection of biologic tissues due to passage of a high frequencyand intensity current.

Blend: Combination of cut and coagulation effects.

Coagulation: Sealing of small blood vessels or biologic tissues due to high frequency current.

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MONOPOLE SURGERY: Patient mostly constitutes he electric circuit. Active lector de is

responsible for conduction of electric current, which goes

through patient body and returns to electrosurgical by neutral plate. In theory neutral plate

does not produce heating effect or burns to tissues because electric current is less concentratedin neutral plate.

BIPOLAR SURGERY: A nippers type electrode is mostly used in this surgery, where

both poles are isolated from ground (isolated scalpels) and act

directly on tissue. As active and neutral poles are placed in same nippers, when activated,

current only circulates by tissue located between poles.

ADVANTAGEOUS USE OF BIPOLAR OUTLET:

1 - Reduces risk to patient, since current does not go through patient body.2 - Reduces hurting of tissues around region where operation is being done. Important

its use in facial restoring surgery, neurosurgery, etc.

3 - Due to concentrated characteristics of dissipation and dissection, produces a more

efficient coagulation of blood vessels, because on humid tissues, with low resistance,

delivers more potency with lower tensions, when in perfect contact with tissue.

DISADVANTAGES:

1 - Contact of nippers with tissue, mainly with dry tissue, it could stick to nippers.

2 - Bipolar outlet always has a reduced potency, thus is less efficient when cutting and

also needs special electrode to cut and not coagulate.

Despite of smaller scape current in bipolar mode, the same cares should be

taken respecting patient isolation.

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BASIC SURGICAL EFFECTS MADE BY ELECTROSURGICAL EQUIPMENTS:

Cut, incision, resection (act of separating surgically): objective

is to heat cellules as quick as to transform them in steam,leaving a cavity in cellular matrix. Since heat is dissipated into

steam, this avoids that neighboring cellules undergo the same

effect. Therefore, it is important that adequate power be used to

obtain smooth cut, because as power increases, tension increases

the same way and the higher tension the more sparks and effects

will occur on neighboring cellules.

Drying, coagulation, hemostasis (act of stanching bleeding):

Drying could be provided with any of these modes: CUT,

BLEND 1 or BLEND 3. Current circulates by tissue, making

water evaporate slowly, differently from cut where cellule

evaporates faster. Normally BLEND 3 is used for drying

because electrode is in close contact with tissue avoids that

sparkling necroses tissue beyond the desired effect.

When CUT is used, work should be done with reduced power to avoid cutting tissue, and

when cutting with hemostasis is needed, BLEND mode will be more efficient.

BLEND 3 can be used to seal vessels, however in humid parts Bipolar outet, as already said,

could be more efficient.

Fulguration, coagulation: BLEND 3 being a short sinusoidal

pulse of peak high voltage, sparks to tissue without cutting

effect. This happens because heating effect is intermittent.

Temperature of water in cellules rises slowly until their

carbonization. Coagulation involves drying so as fulguration

which differs from drying in several aspects. One of them is

that fulguration produces necrosis any place where sparks are

discharged, while in drying sparkling is concentrated on the

area of contact with electrode.

NEUTRAL PLATE: When monopole outlet is in use, neutral plate functions as returningway for scalpel. Plate should be very much bigger than active

electrode and good contact should be kept with patient (whole plate), the nearest possible to

region where surgery will take place, smooth surface of body very well irrigated by blood

vessels. Same should not be placed near ECG electrodes, cables or places where liquids

could accumulate, metallic implants, skin bends, bone bulges, hair in excess, etc.

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BURNS: Intensity of burns will depend on density of escape current and happen if neutral

plate is too small, if there is no good contact to patient, if there are contacts

patient to ground or through a very high capacitance to ground, or patient wears earrings,necklaces or metallic objects entering in contact with any grounded part, if neutral plate is

placed on very haired area, it will not have good contact with patient.

Currently most of ECG monitors are isolated, reducing any possibilities of burns to patient,

but if monitor or cords are with escape to ground, as ECG electrodes are smaller than neutral

plate, burns may occur in region of ECG electrodes.

Synthetic underwear may produce sparks due to static electricity and subsequent ignition of

flammable anesthetics or fluids used for skin cleaning, or electric shock onto another

person.

A current will flow over surface of patient body if something facilitates way, thus when usingflammable liquids in patient disinfection, remove liquids completely. With obese people,

having skin bends or folds able to accumulate liquids, extra care should be taken. With slim

people may also happen above effect, for example, when hip bones press strongly patient skin

and form an isolated point where sweat and liquids accumulate and take long time to

evaporate.

USE OF LOOP TYPE ELECTRODE: When electrodes of this type are employed, some

effects can be obtained by changing loop

diameter or thickness of loop wire. Enlarging loop diameter will have smaller cutting effect,

while increasing diameter of loop wire will have advantage of not damaging easily (burn)

electrode. Nevertheless, to have same results of cutting when using electrode with thinnerwire, power will have to be slightly increased. Power increase should be soft, since high

power facilitates cutting, but can also burns electrode.

PATIENT WITH PACEMAKER: Electrosurgical units must be used with care if

internal or external pacemakers are present because

interference of electrosurgical current may mislead them into asynchronous mode, or could

block completely their effects. When any doubt comes up consult pacemaker manufacturer

and/or cardiology department.

1 Before beginning the surgery check again all connections of active cords, neutral plate, to

avoid sparkling between metals.

2 - Whenever possible, use original instruments always.

3 - If monopole instruments are employed, place neutral plate the nearest possible to surgery

area and always do not let pass the current which circulates from active to neutral

plate near heart.

Notice 1: Monitor always patients with pacemaker during surgery.

Notice 2: Keep always a defibrillator ready, during surgery of patient using

pacemaker.

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NEUROMUSCULAR ESTIMULATION:

Radio frequency is used to prevent neuromuscular stimulation. Since muscles and nerves

have no significant response ability to alternate currents, in frequencies above 100kHz, nevercould be imagined that muscles stimulation could ever be a problem with any scalpel

operating above said frequency, when drying tissue, this is essentially true. Nevertheless,

when making cut or fulguration, spark complicates the problem, as electronic noise producer.

Sparkling toward tissue is a random process and whenever power increases and decreases,

probability of spark jumping to tissue falls. This fault of sparkling and variation of sparkling

current produce low tensions in all DC spectrum, higher or lower than fundamental frequency

of scalpel. In case that this current flows through patient, it will cause stimulation.

In case of sparkling among metals on any point of outlet circuit, components of low frequency

will be generated. This could happen when there is no good contact in some connections

(active and neutral) and could result in contractions or even in pains to awake patient.

If any kind of neuromuscular stimulation happens, observe following items:

1- Check all scalpel connections, return and active electrodes, to find possible

sparkling among metals.

2- Check grounding of surgical center and other equipments.

PACKING AND TRANSPORT

Important:

Electrosurgical packing is appropriate for safe transport. Keep it for eventual transportation

in case of necessity.

Characteristics of packed product:

- Keep always packed product in right direction as indicated on case

- Keep always packed product in humidity protected place

- Keep always packed product in covered place

- Place maximum of 3 packed units above each case

- Storing temperature from 20C to +75C

- Maximum weight distributed over packed product of 17kg.

Packed product can be transported by any means of transportation, under Transmai

Equipamentos Mdicos Ltda. recommendations as above. Transportation of any kind should

be carried out complying with its original packing.

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SELECTION AND USE OF ACCESSORIES

Use always original accessories supplied or indicated by Transmai even those registered and

approved by standards.As to form of utilization of accessories, please see Chapter - Technical Information.

Neutral Plate Cord: Select according to patient, adult or infantile, preferably disposable type

High frequency peak tension (isolation): Over 5k V

High frequency peak current: Over 2 A

Neutral Plate: Select according to patient, adult or infantile



Material: Stainless steel AISI 316L, AISI 420 or for medical use

Standard Pen (Low Surgery): Selection made according to isolation and current



Reusable Bipolar Cord: Selection made according to isolation and current



Bipolar Nippers: Selection made according to isolation and current



Material: Stainless steel AISI 316L , AISI 420 or for medical use

Electrodes: Selection made according to isolation, current and for each type of incision.



Material: Stainless steel AISI 316L , AISI 316 or for medical use

Single Pedal: Should have IPX8 protection

Isolation tension: Over 5kV

Peak current (DC): Over 100mA

Operation tension (DC): from 12 to 24 Vdc

Power Cord: Double isolation with 3 pins (one for ground and protection)

Minimum operation temperature: 70C

Operation tension (minimum): 300Vac

Isolation between conductors (minimum): 750Vac

Minimum current: 12A

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ACESSORIES ACCOMPANYING ELECTROSURGICAL BP-150

01 Neutral Plate, Stainless steel (150 x 100 x 0,5) mm- Ref. PN-100

01 Neutral Plate Cord- Ref. CPN-400

01 Standard Pen - Low surgery Ref. CPB-100

01 Kit electrodes Low surgery Ref. KEB-100

01 Electrode, straight blade type, small size (67mm) Ref. EFR-67

01 Electrode, ball type (=2,1mm)- Ref. EB-2.1

01 Electrode, ball type (=4,2mm)- Ref. EB-4.2

01 Electrode, loop type, small size (=4,5mm)- Ref. EAL-4.5

01 Electrode, needle type (85mm)- Ref. EA-85

01 Electrode, depilation needle type (66mm)- Ref. EA-66

01 Pedal, single- Ref. PS-100

01 User Manual 01 Guarantee Certificate

OPTIONAL ACCESSORIES

Electrode, curve blade type, small size (67mm)- Ref. EFC-67

Electrode, curve blade type, big size (83mm)- Ref. EFC-83

Electrode, straight blade type, big size (100mm)- Ref. EFR-100

Electrode, ball type (=6,0mm)- Ref. EB-6

Electrode, ball type (=7,5mm)- Ref. EB-7.5

Electrode, loop type, big size (

=9,0mm)- Ref. EAL-9 Bipolar Cord, reusable- Ref. CB-400

Bipolar Nippers, isolated, bayonet type- Ref. PBB-400

Bipolar Nippers, isolated, curve type- Ref. PBC-400

Bipolar Nippers, isolated, straight type- Ref. PBR-400

Monopole Nippers, hemostatic- Ref. PMH-400

Services Manual

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ACESSORIES DESCRIPTION

Neutral Plate, Stainless (150x100x0,5)mm-Ref. PN-100 (Accompanying part)

Neutral Plate Cord Ref. CPN-400

(Accompanying part)

Kit of Electrodes, Low Surgery Ref. KEB

(Accompanying part)

A- Electrode, straight blade type, small (67mm)-

Ref. EFR-67B- Electrode, ball type (=2,1mm)- Ref. EB-2.1

C- Electrode, ball type (=4,2mm)- Ref. EB-4.2

D- Electrode, loop type, small (=4,5mm)-Ref. EAL-4.5

E- Electrode, needle type (85mm)- Ref. EA-85

F- Electrode, depilation needle type (66mm)- Ref. EA-66

Pedal, Single Ref. PS-100

(Accompanying part)

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Electrodes (Optional)

A- Electrode, curve blade type, small (67mm)- Ref. EFC-67B- Electrode, curve blade type, big (83mm)-Ref. EFC-83

C- Electrode, straight blade type, big (100mm)-Ref. EFR-100

D- Electrode, ball type (=6,0mm)- Ref. EB-6

E- Electrode, ball type (=7,5mm)- Ref. EB-7.5

F- Electrode, loop type, big (=9,0mm)- Ref. EAL-9

Standard Pen Low Surgery - Ref. CPB-100(Accompanying part)

Bipolar Cord, Reusable- Ref. CB-400

(Optional)

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Nippers (Optional):

Please verify whether case contents all these items and whether they are in good conditions. In case ofany visible damage regarding any above items, please contact Transmai.

BIOCOMPATIBILITY

All parts of equipment, applied parts, accessories, conductive gel, are materials and products

biocompatible. Until present were not detected nor even received information about any

problem of incompatibility. Technical information about incompatibility of materials used in

the manufacture of accessories belong to our technical patrimonial files and are available for

consultation of users.

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IDENTIFYING FRONT PANEL

Picture below shows front panel and functioning description of controls as follows:

ON/OFF SWITCH: Enables turning ON/OFF equipment. And have inbuilt light

signaling ON function.

MONOPOLE KNOB: Enables adjusting ideal intensity of power to make pure cut and

blend, according to position of four keys.

BIPOLAR KNOB: Enables adjusting ideal intensity of power to make pure cut and

blend, according to position of four keys.

MONO KEY: Defines operation mode, monopole (yellow led) or bipolar

(green led).

CUT KEY: Provides smooth cutting with little hemostasis.

BLEND 1 KEY: Inhibits former function and provides smooth cut with more

hemostasis (Mix of cut and coagulation).

BLEND 2 KEY: Inhibits former function and provides smooth cut with morehemostasis than Blend l.

BLEND 3 KEY: Inhibits former function and provides smooth cut with morehemostasis than Blend 2.

ACTIVE INSCRIPTION: Terminal where surgical pen is connected.

NEUTRAL PLATE INSCRIPTION: Connector for neutral plate cord.

PEDALCONNECTOR: To connect pedal plug completely.

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VOLUME KEY: Selects sound level to low, high or off.

BIPOLAR INSCRIPTION: Two terminals without polarity to be used with bipolar

nippers of high isolation. This outlet provides coagulation

of high efficiency and potency, because is only limited to the two poles of bipolar nippers. .

IDENTIFYING REAR PANEL

VOLTAGE SELECTOR SWITCH: Located on rear panel, enables equipment to work

with 110 or 220V network. (FOR SAFETY, EQUIPMENT COMES OUT FACTORY WITH 220V).

NETWORK CONNECTOR AND GENRAL FUSE: Connection for feeding cord and

general fuse holder with 2 fuses in use.

FUSE HOLDER LOW: With 1 fuse in each (phase) for logic circuit protection.

FEEDING CONNECTOR: To connect electrosurgical to electric network.

KNOWING GENERAL FUNCTIONING

GENERAL FUNCTIONING: Turning on equipment, wait for 1 second approx. so

that the whole system starts out. To increase or reduce

outlet power, turn knob as desired. Take care in moving knob, as scales correspond to 1/10 ofmaximum power outlet and little movements increase potency in significant manner.

When outlet is furnished by pedal, electrosurgical will not accept any command, change in

selection of operational mode (Monopole, Bipolar, Cut or Blends), thus to change operational

mode it is necessary that pedal is disabled during this process to the effect of protection to

patient and user.

Selection of Monopole or Bipolar modes is made by pressing once on MODE key and

respective led will turn on and remain switched on until operational mode changes.

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In any function of Monopole mode, when working with pedal yellow indicator led lights on

and respective sound will be heard (unless silenced). If Bipolar mode is selected, when pedal

is working green indicator led lights on and same sound as in monopole mode will be heard

(unless silenced).

To set power outlet, press pedal, then a characteristic sound is heard and the led related to

monopole or bipolar function will be lighted.

Electrosurgical BP-150 memorizes the last situation before turning off, that is, if bipolar

mode and blend 3 were selected when it was turned off, bipolar mode and blend 3 set again

when electrosurgical is on. This also happens in case of black-out.

ALARM:

Electrosurgical BP-150 has a protection circuit which limits power outlet of scalpel to safe

levels of operation. When alarm occurs, a sound signal shoots, ALARM signal winks andpower outlet falls to zero. To get out of this situation operator has to turn off equipment and

turn on it again.

Unique fail alarm happens in the occurrence of some kind of failure where outlet power

exceeds safe levels, or could not be limited. In this situation ALARM led winks and alarm

sound starts. To return to normal condition of work, operator has to turn off and turn on

electrosurgical again.

If in monopole mode any fail of connection of neutral plate occurs, sound signal shoots and

ALARM led winks. The reverse of power excess alarm, as above mentioned, when problem

of neutral plate is solved, sound is silenced, led ALARM stops winking and equipment returns

to normal functions.

SOUND:

Electrosurgical is furnished with two different sounds, one indicates that outlet was energized

(by pressing pedal) and another of alarm.

The volume of sound signal of energized outlet may be adjusted in 0, medium and maximum

by pressing VOLUME key, while sound signal of alarm can not be altered, that means fixed

volume adjusted by factory.

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Chapter 3

USE INSTRUCTIONS


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Chapter 3- Use Instructions____________________________________________________

INSTRUCTIONS FOR USE

1. Before connecting equipment, check whether power of network is the same as indicated by

voltage selector switch located at the rear of equipment. If power does not match, turn switchto right voltage and change protection fuses, caring about placing adequate fuses.

220Volts 3,15General

110Volts 5

2. For operator safety check whether equipment is connected to a real ground, in case of

doubt, this connection must be made preferably by authorized electrician.

3. Plug neutral plate cord pin to connector with inscription Neutral Plate. Next, place

neutral plate in contact with patient skin, if possible near the local of surgical operation. To

avoid bad contact of plate to patient, it is advisable the use ofTransmai Electro conductive

Paste which is conditioned in packing of easy handling. Spill paste all over plate surface and

next put same in contact with patient.

4. Avoid liquid concentrations on any part of body after asepsis and even in course of

surgery.

5. Check always PATIENT / NEUTRAL PLATE / EQUIPMENT perfect contact and avoid

patient contacts with metallic plates on bed or any surgical instrument during surgery.

6. Connect pen to terminal with inscription Active.

7. Connect pedal plug to front panel with inscription Pedal.

8. Select type if electric current in accordance with surgical operation: cut or blend.

9. Adjust current intensity in cut or blends in accordance with surgical operation, starting

always with intensity at zero level and increasing gradually to obtain desired results. Never

begin process with pre-selected level unless it be known for certain such level for such

operation.

10. Turn on equipment and check visual parts like pedal, pen cord, neutral plate, etc.

(Special attention to last two items, since they are not checked by the test circuit of equipment).

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Chapter 3- Use Instructions____________________________________________________

RECOMMENDATIONS DURING SURGICAL OPERATION

1. Check constantly perfect electric and mechanical contact between neutral plate and patient

and existence of conducting gel all over neutral plate surface.

2. Check quality of isolation between surgical table and patient, placing any isolating

material, like pillows of 3 or 4 cm thick between patient and all metallic parts (including

surgical room table, metallic rails, stirrups, etc.) except for neutral plate which never must be

isolated.

3. Avoid skin to skin contact (for example: arms to patient thorax. Dry well these points

and set pieces of dry bandage to avoid new accumulations during surgery).

4. Never connect cardiac monitor ground to neutral plate even if such procedure increases

quality of signal in screen, this is a safety measure for patient.

5. Keep power adjustments at the lowest possible level to increase safety for both patient and

user (since that the power be enough for that procedure).

6. Remove scabs (dark crusts resulting from mortification to parts of tissue), which stick to

electrode points. This will help to increase surgical effect without the need of increasing

power of equipment.

7. When using numerous accessories, keep conductor wires separated, do not interlace, pile

or tie them up together, this could be dangerous and causes interferences.

8. Keep active accessories away from patient when they are not in use.

9. Avoid unnecessary and extended activation of scalpel, as soon as any alteration is

perceived in power normally used (it may be caused by movement of patient over neutral

plate).

10. On simultaneous use of physiological monitoring equipments in same patient, any

monitoring electrodes should be placed as far as possible away from surgical electrodes.

Needle electrodes are not recommended.

11 In patients bearing cardiac pacemaker or other active implants, exist potential risks of

interferences in functioning or damages caused to them. Consult always and/or ask for

approval from qualified persons.

12. Occasional faults of electronic component parts may occur due to unwilling conduction

like overcharge, lightning, fall of equipment to floor, sterilization of accessories at

temperature above 130C and so on. It is important to have always available spare equipment

and accessories.

13. Use the shortest possible cord to avoid loops.

14. Surgeon must always wear isolating gloves, mainly when using manual command

scalpels, metallic instruments (scissors, nippers) and in bipolar surgery.

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Chapter 3- Use instructions________________________________________________

REMARKS

Effective and safe application of Transmai Electrosurgical BP-150 very much depends ongrade of operator experience with this equipment particularly and on diverse surgery

techniques.

Therefore, recommendation is made for utilization of one piece fresh and moist raw meat, left

to warm at ambient temperature (the nearest possible to human body temperature, as chilled

meat delays effects of electric current).

Place meat piece over neutral plate duly connected to scalpel.

Put electrode in contact with meat piece, to be cut or coagulated, only after this, pedal will

be set in motion, this way carbonization of tissue will be avoided.

Increase and decrease gradually between minimum and maximum on scale of power

intensity control in the eight electric current modalities.

MONOPOLE (Yellow knob): Cut, Blend1, Blend2 and Blend3

BIPOLAR (Green knob): Cut, Blend1, Blend2 and Blend3

Observe effects of each one over meat in diverse power ranges until becoming acquainted

with this electrosurgical model.

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Chapter 4

CARE AND MAINTENANCE


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Chapter 4- Care and maintenance____________________________________________

CLEANING

Equipment must be kept clean and dust free. Turn it off before cleaning. Use a soft cloth,

moistened with a solution of water and neutral soap or isopropyl alcohol (isopropanol)followed by a dry cloth.

Never use abrasive materials because they could compromise cabinet and principally

polycarbonate displays.

Never sink it in liquids.

Electrodes and nippers should be re-sterilized in autoclave at temperatures below 130C after

every surgical operation.

Do not try sterilization in autoclave of accessories such as neutral plate, pedal or any other not

indicated for this condition. Disinfect using specific products for this application, such as

isopropyl alcohol (blood and tissues), enzymatic detergents (blood and tissues) glutaricaldehydes (use for disinfection of rubber parts, PVC, ETC.). When using flammable

products for disinfection or sterilization, remove all excess and be certain that all is absolutely

dry to avoid combustion of product during use.

In the event of entering liquids in excess into electrosurgical, let it out of operation, for a

period of 24hs minimum, disconnected from electric network, in ventilated place away from

direct sunlight.

In case of fall, send it to authorized technical assistance for maintenance and/or general

inspection of equipment.

GENERAL CARE AND STERILIZATION

Transmai Electrosurgical BP-150 must be kept clean and dust free. Turn it off before

cleaning. Use a soft cloth, moistened with a solution of water and neutral soap,

followed by a dry cloth.

Never use abrasive materials because they could compromise cabinet and principally

polycarbonate displays.

Never disconnect accessories by pulling cord. Pull always by connector.

In case of disinfection by autoclave, verify whether accessory is appropriate forprocedure of this kind..

BP-150 accessories can be cleaned with a humid cloth or sponge. If necessary, pedal,

plate cord and standard pen could be disinfected by rubbing alcohol 70%, soft

bleaching solution or any other disinfectant. Optional pen, neutral plate and electrodes

can be sterilized in autoclave or with ethylene oxide (ETO).

Note: Standard pen should be sterilized with ethylene oxide (ETO).

Check all accessories before every surgical operation.

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Permanent Neutral Plate: Monopole outlet functions as a return of current

to scalpel. It should be much bigger that active

electrode and good contact with patient (plate in whole) should be kept, the

nearest possible of surgery work, an even part of body very well irrigated byblood vessels.

It should not be placed adjacently to ECG electrode and cord, places where

accumulation of liquids may occur, metallic implants, skin bends, bone bulges, hair in

excess, etc.

In case of using together with ECG monitors, it is advisable

that neutral plate be placed according to picture at left.

When monitoring with ECG electrodes, care should be taken

for application on coronary region.

Keep neutral plate and active electrode cords the shortest

possible and without contact with ECG cord.

During surgery operation it should be avoided that cords

remain rolled up and in contact with grounded metallic parts.

Blade type electrodes are more frequently used in cut

incision, resection (to separate surgically).

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Ball type electrodes are more frequently used in dissection, coagulation, hemostasis

(hemorrhage interruption) and fulguration.

Loop type electrodes are frequently used to dissection polyps and in need of takingsamples of tissues.

Needle type electrodes are frequently used in depilation.

Elimination of disposable products, equipment residues and accessories:

When using parts or accessories and residues enter in direct contact with blood (invasive) or

patients with infectious-contagious diseases, said parts must be discarded in recipients proper

for discarding cut/perforating objects.

In the event of doubts use always recipients proper for discarding cut-perforating objects or

consult competent persons to take a decision, but never cast those objects into commongarbage.

INTERFERENCES

Function principle of electrosurgical makes that same be an emitter source of noises. Armors

and filters were projected to minimize these effects. Nevertheless, during surgical operation,

contact of active electrode with patient tissue sparkling happen which will produce noise and

active electrode will function as an antenna irradiating it in all directions. Therefore, before

surgical operation, care should de taken in checking equipments more influenced by

interference.

INTERFERENCES IN PACEMAKERS

a) Before beginning surgical operation, check again all connections of active cords and

neutral plate to avoid sparkling among metals.

b) If possible, use always a ground specific for this equipment.

c) When using monopole instruments, put neutral plate in the nearest possible position

to local of surgery works, always avoiding that the current which circulates from

active to neutral plate do not pass by the proximities of heart.

_______________________________________________________________Transmai BP-150 29


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Notice 1: Monitor always patient with pacemaker during surgical operation.

Notice 2: Keep always a defibrillator, ready to use, during surgical operation in

patient with pacemaker.INTERFERENCE IN MONITOR (ECG):

a) Check chassis ground connections of both equipments.

b) Check all electric equipments in surgical room, respecting defective grounding.

c) When there are different equipments grounded to different grounds, a potential difference

may appear and monitor could respond to same.

MAINTENANCE

Electrosurgical BP-150 should be only repaired by Transmai technical Service or authorizedstaff.. Inadequate maintenance may compromise safety of patient.

Preventive maintenance and calibration of equipment must be done annually.

Check always correct work of all equipments involved in surgical operation and observe basic

rules recommended for electro surgery.

The factory is not responsible for wrong use of this equipment and advises against

manipulation by persons with lack of wide and total knowledge of electro surgery techniques.

Fuses replacement: General Fuse Turn off general key on front panel of equipment,

disconnect power cord from network and equipment, then unlock fuse holder with a

screwdriver and replace them in accordance with table below.

220Volts 3,15AGeneral

110Volts 5

After replacement carry out basic inspection of electrosurgical and in the event of doubts or

whether burning of fuses persists, contact authorized technical assistance or Transmai

directly.

INSPECTION AND PREVENTIVE MAINTENANCE

ACCESSORIES: Before any surgical proceeding all accessories should be submitted tovisual and operative review. This instrumental inspection should be

carried out by the company itself through maintenance staff.

Neutral Plate Cord and Permanent Neutral Plate:

Visual- Integrity of cord, connector and neutral plate. Instrumental- Adjust multimeter for

reading resistance at lowest scale. Resistance should remain below 10Ohms.

Operative- Connect to scalpel and alarm and alarm should not go off.

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Operating Pedal:

Visual- Entireness of cord and connector. Instrumental- With multimeter check continuity

and operating.

Operative- Connect to scalpel (adjusted at 0% in all modes), press and verify operatingthrough sound and visual signals concerning each operational mode.

Standard Pen, Autoclavable:

Visual- Entireness of cord and connector. Insert one of electrodes to pen and check its perfect

and firm setting. Fit in electrosurgical and check firmness of setting.

Cord and Nippers, Bipolar:

Visual- Entireness of cord and connector. Check perfect fitting (firm) of nippers to cord and

cord to electrosurgical.

Instrumental- With multimeter check continuity of cords.

ELECTROSURGICAL: Before any surgical proceeding equipment will be checked andpreventive maintenance is to be made every year.

Visual- Check entireness of cabinet, perfect fitting of power cord and accessories.

PROBLEMS AND SOLUTIONS

Problem Possible Cause Solution

Burning of fuse Replace fuse

Power cord Replace power cord1- Turned on it does not work /

no signals are lightedLack of electrical energy Solve problem

2- Turned on and light of

On/Off key is not on.Internal neon lamp Replace lamp

Power circuit

Control circuitContact Technical Assistance

3- Power is very weak

Pen cord rupture Replace pen cord

Control potentiometer Replace potentiometer

Accessories Replace accessories

4- Power very much reduced at

same point already selected

before

Power circuit Contact Technical Assistance

5- No sound Loudspeaker Loudspeaker

Keyboard Replace keyboard6- No current at outlet

Pedal Replace or repair pedal

Power circuit

Control CircuitContact Technical Assistance

_________________________________________________________________Transmai BP-150 31


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Note: Any other doubt or problem not mentioned above, please contact Transmai or

Authorized Technical Service.

CONCLUSION

Check always correct work of all equipments involved in surgical operation and observe basic

rules recommended for electro surgery.

The factory is not responsible for wrong use of this equipment and advises against

manipulation by persons with lack of wide and total knowledge of electro surgery techniques.

TECHNICAL SPECIFICATION

Monopole Power: Cut: 150W Charge: 300 Ohms

Blend1: 100W Charge: 300 Ohms

Blend2: 75W Charge: 300 OhmsBlend3: 20 Charge: 300 Ohms

Bipolar Power: Cut: 70W Charge: 100 Ohms




Potential could vary with regard to nominal values in 20% or 10W(at 110Vac), whatever be

higher.

Operating Frequency: 480 kHz

Feeding: 110/220 Vac (Automatic) 580VA - 50/60Hz

Adequate connection to electrical network CISPR 11

RF ESCAPE CURRENT: Bipolar :


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CLASSIFICATION OF PRODUCT:

Type of protection against electric shock: Class I Equipment

Grade of protection against electric shock: Applied part of CF type defibrillation-proof. Grade of protection against harmful water penetration: IPX0 Equipment

Grade of safe application in presence of flammable anesthetic mix with air, oxygen or

nitrous oxide: non adequate

Mode of operation: Continuous with intermittent charge Time ON = 10seconds

- Time OFF = 30seconds

Physiological effects: Equipment causer of physiological effects to patient and/or operator

Documentation: Through users request and under company regulations electrical diagrams

and component parts list will be available.

Ambient Temperature: 0 - 50o

C

Transport and storage:

Electrosurgical is packed with an extra protection of expanded polyurethane, to absorb

vibrations and impacts during transport. Keep this material for future transportation.

In the event of flakes as vibration and impact absorbers, the first packing should be a plastic

bag to avoid powder going inside of equipment and piling up and maximum weight upon case

would be lesser than specifications.

Specifications Electrosurgical only

Maximum piling 03 units

Transport and storing temperature -20 to +75C

Weight upon case during transport and storing 17kg

Relative humidity of storing 10 to 90%

OPEN TENSION X SCALE: BP-150

_______________________________________________________________Transmai BP-150 33


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Chapter 4- Care and maintenance________________________________________________

POTENTIAL x SCALE x CHARGE CURVES:

Measures: High: 14,4cmWidth: 23,0cm

Depth: 23,5cm

Weight: 3,5kg

BIBLIOGRAPHY

1- Patient Safety in the Use of Electro surgical Devices

U.Pohl

OR male-nurse, Westphalian Wilhelms University, Mnster

2- Patient Safety in the Use of Electro surgical Devices

Wiedner-Heil

DBfk Verband

3- Principles of Biomedical Instrumentation and Measurement

Richard Aston

Merrill Publishing Company

_______________________________________________________________Transmai BP-150 34


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Guarantee

GUARANTEE

MedGyn Products Inc. assures to owner-consumer of equipment herein identified, guarantee

against manufacturing defects as long as proved by technician authorized by Transmai, for aperiod of 365 days counted from date of purchase by first buyer-consumer on, for product

described on invoice.

Transmai Equipamentos Mdicos Ltda. declares this guarantee invalid for all intents and

purposes if this equipment suffers any damage caused by accidents, nature elements

(lightning, floods, collapses, fall, bad use, etc.), use disagreed with Instruction Manual, for

connection to unsuitable electric wiring or subjected to excessive fluctuations, or in the event

of presenting violation signals, repairs by technician non authorized by Transmai.

Note that guarantee will be invalid if purchaser does not present the invoice evidencing

purchasing equipment or if said document contents erasures or alterations.

Transmai Equipamentos Mdicos Ltda. is obliged to provide the services above referred.

Owner-consumer will only be responsible for cost and risks of transport (there and back) of

equipment to manufacturer.

___________________________________________________________________________

This product is exclusively destined to medic-hospital use


Av. Maria Estela, 33 - Jardim Maria Estela

CEP: 04180-010 - So Paulo SP - Brasil

+ 55 11 2335.1000

Fax extension 210

__________________________________________________________________Transmai BP-150 35


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Guarantee_________________________________________________________________

CERTIFICATE OF GUARANTEE

This equipment has guarantee valid for 1 (one) year, counted from date of acquisition on,

against manufacturing defects under following conditions:

A-) Devolution of duly filled in Notice-Card to factory, within 10 (ten) days after

purchase.

B-) Correct and careful use with specified voltage only.

C-) Repairs only by authorized distributors or manufacturer.

D-) Presentation of supporting bill of sale together with this certificate dully filled in

eventual need of repairs.

In the event of repairing in factory send together with equipment:

A-) Distributors: Consignment Note for repairs. (None other document will be accepted).

ATTENTION:

B-) Hospitals, Doctors, Clinics, Charities: Letter on heading paper containing name and

signature of owner or responsible officer, address, phone number, city and state, register

codes and indicating if previous budget is desired.

Distributor:__________________________________________________________________

Address:____________________________________________________________________

City:_____________________________________ State:_____________________________

Equipment:_____________________________________________ N__________________

Invoice:_____________________________________ Date:___________________________


Av. Maria Estela, 33 - Jardim Maria EstelaCEP: 04180-010 - So Paulo SP - Brasil

+ 55 11 2335.1000

Fax extension 210

Date post:	03-Apr-2018
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