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Baylis RFP-100A User Manual

Radiofrequency puncture generator
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BAYLIS MEDICAL COMPANY RADIOFREQUENCY
Carefully read all instructions prior to use.
precautions noted in these instructions. Failure to do so may result in patient complications.
Manufacturer:
EU Authorized
Representative:
PowerWire, NRG, VersaCross, DuoMode and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company
Inc. in the United States of America and/or other countries. All other trademarks or registered trademarks are property of their respective owners.
© 2012-2019 Baylis Medical Company Inc.
PUNCTURE GENERATOR
RFP-100A
ENGLISH
User's Manual
Baylis Medical Company Inc
5959 Trans-Canada Highway
Montreal, Quebec
Canada
H4T 1A1
Phone: +1 (514) 488-9801
Fax:
+1 (514) 488-7209
Quality First International
20 Eversley Road
Bexhill-on-Sea
East Sussex
TN40 1HE
United Kingdom
Phone: +44-(20)-8-522-1937
Fax:
+44-(20)-8-522-1937
Patents pending and/or issued.
1 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
Observe all contraindications, warnings and
1639

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Amy Iams
July 9, 2025

Is there an MIFU for RFP 100A connector cable? Specifically how many times can you re-sterilize this item before discarding?

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Summary of Contents for Baylis RFP-100A

  • Page 1 +44-(20)-8-522-1937 PowerWire, NRG, VersaCross, DuoMode and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the United States of America and/or other countries. All other trademarks or registered trademarks are property of their respective owners.
  • Page 2 © 2012-2019 Baylis Medical Company Inc. 2 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 3 This page is intentionally left blank © 2012-2019 Baylis Medical Company Inc. 3 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 4: Table Of Contents

    ACTIVATE RF ENERGY DELIVERY ....................28 7.11. DEACTIVATE RF POWER DELIVERY ....................29 7.12. RE-APPLY RF POWER .......................... 29 7.13. PROCEDURE COMPLETE ........................29 SECTION 8: SERVICE AND MAINTENANCE ..............30 © 2012-2019 Baylis Medical Company Inc. 4 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 5 ALERT CODES ............................36 9.5. IEC ELECTRICAL SAFETY AND EMC SPECIFICATIONS ............... 39 9.6. LABELING AND SYMBOLS ......................... 43 SECTION 10: LIMITED WARRANTIES AND DISCLAIMER......... 46 © 2012-2019 Baylis Medical Company Inc. 5 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 6: List Of Figures

    Table 9.5-2 IEC EMC Specifications (Emissions) ............... 39 Table 9.5-3 IEC EMC Specifications (Immunity) ................ 40 Table 9.5-4 IEC Recommended Separation of RF Communication Equipment ......42 © 2012-2019 Baylis Medical Company Inc. 6 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 7: Preface

    User covenants not to use the Generator in conjunction with any unauthorized products, items, consumables, disposables, equipment or parts. User specifically agrees that Baylis Medical shall not be liable for damages, personal injury or death if the RF Generator is used in conjunction or with any unauthorized products, items, consumables, disposables, equipment orparts.

  • Page 8: Device Description

    SECTION 1: DEVICE DESCRIPTION The Generator is a component of the Baylis Medical Company Radiofrequency (RF) Puncture System. The Generator is operated in conjunction with separately cleared BMC RF Devices, BMC connector cables such as (but not limited to) the RFX-BAY-TS, RFX-BAY-TS-12-SU or RFX-...

  • Page 9: Indications/Contraindications

    SECTION 2: INDICATIONS/CONTRAINDICATIONS 2.1. INDICATIONS FOR USE The Baylis Medical Company Radiofrequency Puncture Generator & Footswitch is to be used with separately approved radiofrequency devices in general surgical procedures to cut soft tissues. 2.2. CONTRAINDICATIONS The BMC Radiofrequency Puncture Generator is not recommended for uses other than the indicated use.

  • Page 10: Warnings, Precautions, And Adverse Events

    The use of needle monitoring electrodes (or other small area electrodes) during RF output is not recommended. In all cases, incorporating high frequency current limiting devices are recommended. © 2012-2019 Baylis Medical Company Inc. 10 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 11: Precautions

    • It is recommended not to exceed the specified number of RF energy applications per BMC RF Device, as indicated within the BMC RF Device’s specific instructions for use. © 2012-2019 Baylis Medical Company Inc. 11 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 12 • Baylis Medical Company relies on the physician to determine, assess, and communicate to each individual patient all foreseeable risks of the Generator.

  • Page 13: Adverse Events

    The BMC RF Device Instructions for Use should be consulted for any other adverse events that may be associated with use of that separately cleared device. © 2012-2019 Baylis Medical Company Inc. 13 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 14: Unpackaging And Repackaging

    Generator and accessories carefully and visually inspect the front panel, chassis, or cover for damage. If any physical damage is found, DO NOT USE THE GENERATOR. CONTACT Baylis Medical Company for a replacement. Notify the carrier immediately if the shipment carton is damaged.

  • Page 15: Controls, Displays, And Connections

    NOT connected to the generator OR when the measured impedance of a monitoring (dual foil) return electrode is greater than 150 ohm, indicating poor patient contact. Note: Only use return electrodes that meet or exceed IEC 60601-2-2:2017 requirements. © 2012-2019 Baylis Medical Company Inc. 15 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 16 (dual foil) electrodes can be used. (13) Connector Cable Connection: This patient isolated connection is for the attachment of the RFP-100A connector cable. The user shall refer to the BMC RF Device instructions- for-use to select the proper connector cable model.

  • Page 17: Rear Panel Displays, Controls, And Connections

    (5) FOOTSWITCH Connection: This connection is for the attachment of the FOOTSWITCH. Like the RF ON/OFF button, the FOOTSWITCH initiates and terminates RF energy delivery. However, its action is different than the RF ON/OFF © 2012-2019 Baylis Medical Company Inc. 17 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 18 (8) TUV Product Service (c-us) Mark Label (9) Device Label: This label indicates the model number, serial number, and manufacturer contact information. Symbols found on this label are described in Section 9.6. © 2012-2019 Baylis Medical Company Inc. 18 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 19: Generator States Flow Chart

    5.3. GENERATOR STATES FLOW CHART Figure 5-3 – Generator States Flow Chart © 2012-2019 Baylis Medical Company Inc. 19 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 20: Displays

    • A tone is sounded once POST is successfully completed. • If the Generator does not enter POST, then it will be considered as an error (see FAULT state). Figure 6-2- POST Display © 2012-2019 Baylis Medical Company Inc. 20 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 21: Standby State

    • TIME and CUT settings can be adjusted with the left and right soft keys beside the arrows. • RF energy delivery can be initiated by either pressing the RF ON/OFF button or pressing and holding FOOTSWITCH. Figure 6-4a- READY State Display © 2012-2019 Baylis Medical Company Inc. 21 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 22: On State

    ALERT or ERROR condition. Figure 6-5- ON State Display 6.5. ALERT • An ALERT is presented when an alert condition is met in STANDBY, READY, or ON States. © 2012-2019 Baylis Medical Company Inc. 22 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 23: Fault (Error) State

    • The user must record the error code and cycle main power (off-on) to the Generator to attempt recovery from a system error. Contact Baylis Medical Clinical support if error persists. • A tone is sounded, “ERROR” is displayed in a red status bar, an error code is displayed, and the FAULT Indicator flashes red.

  • Page 24: Figure 6-9- Setup State Display

    1 – 10 SETTINGS - TIME Generator is powered up STARTUP Value for CUT mode setting Device Pulse SETTINGS – CUT when Generator is powered up Dependent © 2012-2019 Baylis Medical Company Inc. 24 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 25: Figure 6-10- Setup State Display

    Generator number. Also found on rear device label. Not adjustable. Standard Displays Generator time Time and Time / Date and date. Adjustable by Date user. Increment © 2012-2019 Baylis Medical Company Inc. 25 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 26: Directions For Use

    Do not twist the connector of the BMC Connector Cable while inserting or removing it from the Generator receptacle. Doing so may damage the pin connections. © 2012-2019 Baylis Medical Company Inc. 26 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 27: Connect The Dispersive (Return) Electrode

    IEC 60601-2-2:2017 requirements (such as ConMed MacroLyte Dual Dispersive Electrode), loss of safe contact between the dispersive electrode and the patient may not result in an auditory alarm. © 2012-2019 Baylis Medical Company Inc. 27 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 28: Turn The Generator "On

    If the Generator fails again, the Generator will not function properly and the error code should be recorded. Baylis Medical Company should be contacted for service. The Generator will NOT operate unless the power on self-tests have been successfully completed.

  • Page 29: Deactivate Rf Power Delivery

    If other connectors were used (e.g. footswitch, USB, etc), they should be disconnected as necessary to ensure safe storage of the Generator and accessories. © 2012-2019 Baylis Medical Company Inc. 29 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 30: Service And Maintenance

    WARNING: Using different rated fuses than specified can result in permanent damage to the Generator! 8.3. DISPOSAL For disposal of the Generator at the end of its service life, please contact Baylis Medical. © 2012-2019 Baylis Medical Company Inc. 30 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 31: Specifications

    Keyed Quick Connect female 4 pin Return Electrode Connection: Standard male 2-pin for commercial pads Recommended Dispersive ® ® Electrode: ConMed MacroLyte 400-2100 Footswitch Connection: Metal Keyed Quick Connect 4pin © 2012-2019 Baylis Medical Company Inc. 31 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 32 Enclosure Leakage (Ground Open, Power Reversed) < 300 uA Dielectric Withstand (Hi-Pot) Test: Mains to Chassis (1500VAC, 1min) PASS Mains to Applied Parts (4,000 VAC, 1min) PASS © 2012-2019 Baylis Medical Company Inc. 32 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 33: Generator Mode Settings

    Table 9.2-1- CUT and TIME settings for each Generator Mode Mode CUT setting Max Output Pulse Duty Pulse max TIME Voltage (V Cycle (%) Frequency (Hz) Constant Pulse Constant Pulse STX Low STX High © 2012-2019 Baylis Medical Company Inc. 33 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 34: Output Energy Figures

    Figure 9-1 Maximum Power Ouput for Mode 10 Constant Maximum Power Output vs. Load: Mode 10, 400Vrms, Pulse Load Impedance (Ω) Figure 9-2 Maximum Power Ouput for Mode 10 Pulse © 2012-2019 Baylis Medical Company Inc. 34 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 35 Figure 9-3 Maximum Power Ouput for Mode 12 Constant Maximum Power Output vs. Load, Mode 12 270Vrms, Pulse Load Impedance (Ω) Figure 9-4 Maximum Power Ouput for Mode 12 Pulse © 2012-2019 Baylis Medical Company Inc. 35 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 36: Alert Codes

    Contact Baylis Clinical Support. channel configuration. A018 Device not connected Either connector cable is not functioning or not connected when attempting to © 2012-2019 Baylis Medical Company Inc. 36 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 37 A029 Invalid device detected. Invalid connector cable connected to the Record alert code and contact Generator. Replace connector cable. Baylis Clinical Support. © 2012-2019 Baylis Medical Company Inc. 37 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 38 Summary of Alert Codes, Displayed Text, and Description Alert Code Displayed Text Description A030 Record Alert Code and Handswitch Fault contact Baylis Clinical Support. © 2012-2019 Baylis Medical Company Inc. 38 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 39: Iec Electrical Safety And Emc Specifications

    Class A Harmonic emissions voltage power supply network that supplies buildings used for domestic purposes. IEC 61000-3-2 Complies Voltage fluctuations/ flicker emissions IEC 61000-3-3 © 2012-2019 Baylis Medical Company Inc. 39 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 40: Table 9.5-3 Iec Emc Specifications (Immunity)

    30 A/m 30 A/m commercial or hospital magnetic field environment. IEC 61000-4-8 NOTE U is the a.c. mains voltage prior to application of the test level. © 2012-2019 Baylis Medical Company Inc. 40 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 41 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. © 2012-2019 Baylis Medical Company Inc. 41 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 42: Table 9.5-4 Iec Recommended Separation Of Rf Communication Equipment

    NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. © 2012-2019 Baylis Medical Company Inc. 42 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 43: Labeling And Symbols

    Dispersive (Return) Electrode connection; High Frequency Isolated Patient Circuit Connector Cable connection RF Output OFF RF Output ON AC Mains Power USB-A Port Set Time TIME Cut mode Down © 2012-2019 Baylis Medical Company Inc. 43 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 44 Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Follow Instructions for Use Consult Instructions for Use Storage Conditions Temperature Limit © 2012-2019 Baylis Medical Company Inc. 44 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...
  • Page 45 Use of this symbol indicates that the product must be disposed of in a way that complies with local and national regulations. For questions regarding recycling of this device please contact your distributor. © 2012-2019 Baylis Medical Company Inc. 45 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx...

  • Page 46: Section 10: Limited Warranties And Disclaimer

    The customer shall obtain a return authorization number before shipping the unit back. Baylis Medical at its sole discretion can repair the unit or ship a new one. The units are to be shipped freight pre-paid for both the warranty period and out of warranty.
  • Page 47 THESE PRODUCTS ARE BEING SOLD ONLY FOR THE PURPOSE DESCRIBED HEREIN, AND SUCH WARRANTY ONLY RUNS TO THE PURCHASER. IN NO EVENT SHALL BAYLIS MEDICAL BE LIABLE FOR ANY BREACH OF WARRANTY IN ANY AMOUNT EXCEEDING THE PURCHASE PRICE OF THE PRODUCT. SELLER'S MAXIMUM...
  • Page 48 Buyer will not resell or redistribute Products to entities or persons, except with Baylis Medical’s prior written consent. No agent, employee or representative of Baylis Medical has the authority to bind the Company to any other warranty, affirmation or representation concerning the product.

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