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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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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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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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- 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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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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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
High frequency peak tension (isolation): Over 5k V
High frequency peak current: Over 2 A
Material: Stainless steel AISI 316L, AISI 420 or for medical use
Standard Pen (Low Surgery): Selection made according to isolation and current
High frequency peak tension (isolation): Over 5k V
High frequency peak current: Over 2 A
Reusable Bipolar Cord: Selection made according to isolation and current
High frequency peak tension (isolation): Over 5k V
High frequency peak current: Over 2 A
Bipolar Nippers: Selection made according to isolation and current
High frequency peak tension (isolation): Over 5k V
High frequency peak current: Over 2 A
Material: Stainless steel AISI 316L , AISI 420 or for medical use
Electrodes: Selection made according to isolation, current and for each type of incision.
High frequency peak tension (isolation): Over 5k V
High frequency peak current: Over 2 A
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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Chapter 4- Care and maintenance____________________________________________
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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Chapter 4- Care and maintenance____________________________________________
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.
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Chapter 4- Care and maintenance____________________________________________
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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Chapter 4- Care and maintenance____________________________________________
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
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Chapter 4- Care and maintenance____________________________________________
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
Blend1: 50W Charge: 100 Ohms
Blend2: 30W Charge: 100 Ohms
Blend3: 20W 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
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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
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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
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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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:___________________________
Transmai Equipamentos Mdicos Hospitalares Ltda.
Av. Maria Estela, 33 - Jardim Maria EstelaCEP: 04180-010 - So Paulo SP - Brasil
+ 55 11 2335.1000
Fax extension 210