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Summary of Contents for SMT BM 170
- Page 1 Electrosurgical Unit ELECTROCOAGULATOR SMT BM 170 BM 125 BM 100 BM 75 Instructions for Use...
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Page 3: Table Of Contents
2.1. How electrosurgery works ............4 2.2. Main advantage of using electrosurgery ........4 2.3. Operation mode ................. 4 2.4. Operation output ................ 4 ELECTROCOAGULATOR SMT SYSTEM ........6 3.1. Control Unit ................6 3.2. Applicator (holder of operation electrode) ......7 3.3. -
Page 4: Introduction
Manufacturer: Speciální Medicínská Technologie, s.r.o. Zbraslavská 1113, 252 42, Jesenice, Czech Republic Phone: +420 233 320 201 E-mail smt-praha@smt-praha.com URL: http://www.smt-praha.com Class of medical device: II b Device service life: 7 years (Date of the end of service life is on manu- facturer´s label in format: yyyy-mm) -
Page 5: Warning
1.1. Warning: Visual inspection of all parts of the device is required before each use of the device. When the output power is activated the device may generate electromagnetic interference, which may affect the operation of other electrical devices. The device can be operated only by persons who have been trained by the manufacturer or authorized person. -
Page 6: General Information
2. GENERAL INFORMATION 2.1. How electrosurgery works Electrosurgery works on principle of increase the heat during electric current flow. In place of contact with tissue is increased the heat proportional to the current density, that mean, that smaller tool surface (the electrodes) mean the higher the heat of tissue. - Page 7 2.4.2. Coagulation (COAG) The Coagulation is created by modulate sinus output signal, which causes increase the temperature into the cells to 60°C, that causes to desiccation of cells and start haemostasis. It is used with electrosurgical electrodes with bigger area like for example balls.
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Page 8: Electrocoagulator Smt System
( BM 75 have footswitch without metal stand) 3.1. Control Unit Control Unit is main part of Electrocoagulator SMT using like generator of high frequency electric current. Allows set one of 4 operation outputs (Cut, Coag, Blend, Micro) in both modes (Mono or Bipo). -
Page 9: Applicator (Holder Of Operation Electrode)
Applicator is used to connection of operation electrode to control unit in mono- polar mode. Designated accessories: Applicator SMT 2.4 ................REF 160 60 Applicator SMT 1.6 ................REF 160 61 3.3. Operation electrode (Active) Operation electrodes are used to targeting high frequency current to the tis- sue. -
Page 10: Bipolar Accessories
In case using the neutral electrode with more than one electric circle (standard are two) is automatically monitored the quality of connection between the pa- tient and the neutral electrode. That means if the neutral electrode isn´t con- nected to the patients (or is connected only small parts of electrode) the con- trol unit blocks the output and start alarm. -
Page 11: General Technical Parameters
4. GENERAL TECHNICAL PARAMETERS 4.1. General parameters Input voltage ................~ 230 V, 50 Hz Power consumption in load: BM 170 ....................250 VA BM 125 ....................190 VA BM 100 ....................140 VA BM 75 ....................105 VA Power consumption in stand by ..............27 VA... - Page 12 Transformer ..................Prim. = 230V ............sec. 1 = 57V / 3A (45V / 2A in type 75 MB) ................... sec. 2 = 16V / 0.5A Operating conditions: ................ 10°C to 40°C Temperature Relative humidity ..............30% to 75% Atmospheric pressure ..........
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Page 13: Request About Electromagnetic Compatibility (Emc)
4.2. Request about Electromagnetic Compatibility (EMC) The device is source of electromagnetic interference........Caution: Device malfunction may cause increases the output power. Caution: It is important to avoid using the device next to or with other devices, because it may cause malfunctions. If such use is required, the instruments should be monitored to verify that they are functioning normally. -
Page 14: Use, Operation And Maintenance
5. USE, OPERATION AND MAINTENANCE 5.1. Description of front panel Signalization of operation output Signalization of active mode Signalization of problem with NE Switch to switching mode Signalization switch ON/OFF Socket to connect applicator Switcher of operation outputs Socket to connect NE Regulator of output power Sockets to connect bipolar forceps Display... -
Page 15: Before Use
5.3. Before use Caution: All accessories are supplied by the manufacturer non-sterile and non-cleaned unless on the accessory packaging isn´t specifies otherwise. Pri- or to first use, it is necessary to clean and sterilize according to this Instruc- tions for Use (5.5). 1. -
Page 16: Use
In case using bipolar mode: Connect the fork of bipolar cable to the connector on the front panel of control unit (5.1. - 11). To the second end of the bipolar cable put bipolar forceps, pean or other bipolar accessories. 5. -
Page 17: Re-Use
Caution: Electrosurgical cables should be situated as far as possible from control unit and should not form loops around metal objects. Temporarily de- posed electrodes must be separated from the patient. Caution: Don´t use flammable substances. Watch out for disinfection on alco- holic base and medical gas (N O and oxygen). -
Page 18: Services
5.7. Services Speciální Medicínská Technologie, s.r.o Zbraslavská 1113, 252 42, Jesenice, Czech Republic, EU Phone: +420 233 320 201, E-mail: obchod@smt-praha.com www.smt-praha.com 5.7.1. Periodic control Periodic safety and technical inspection must be performed at least once a year (but it also depends on country regulations). The control may be per- formed by authorized service facility or manufacturer. -
Page 19: Guarantee
Notified Body No. 1014 – Electrotechnical Testing Institute (EZU) - Pod Lisem 129, Prague 8, 171 02. No materials prohibited by Directive 2011/65 / EU have been used to produce the SMT BM Electrocoagulator and not contain active substances, human blood derivatives, phthalates, or any other similar substances. -
Page 20: Used Labels
8. USED LABELS Isolated Manufac- Atmospher- electric turer ic pressure circle Defibrilla- Service General tion-proof life warning applied parts BF Serial Applied CE Mark number parts BF The device contains On / Off RF trans- Catalog mitter. May number STAND-BY interfere mode with other... -
Page 21: Indemnity Agreement
9. INDEMNITY AGREEMENT Product: ELECTOCOAGULATOR SMT Type: BM 75 BM 100 BM 125 BM 170 Serial number: Date of sale: Stamp and signature of expedition: Guarantee Condition: At observing Instructions for Use the manufacturer guarantees that the product shall have characteristics assessed by the relevant technical conditions and standards for the duration of 24 months from the date of sale. -
Page 22: End User Registration Card
10. END USER REGISTRATION CARD We will pleasure if we you fill this Registration Card and send it (in scan form) on e-mail address: obchod@smt-praha.com Type: Serial Number: User: Address: Contact (phone or e-mail): Suggestions for improvements Please share your impressions from this device that we can continue to improve it as effectively as possible. - Page 24 Speciální Medicínská Technologie, s.r.o. Zbraslavská 1113 252 42 Jesenice Czech Republic, EU Phone: +420 233 320 201 E-mail: obchod@smt-praha.com www.smt-praha.com N00 100.09 The last revision and issue of this Instruction for Use: 12.2.2021...
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