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DMR RFA-FS 3.3 V-9 19-May-2021
EU Importer:
MedEnvoy
Prinses Margrietplantsoen 33 – Suite 123
2595 AM The Hague
The Netherlands
© Copyright Baylis Medical Company Inc., 2011-2021
The Baylis Medical logo is a trademark and/or a registered trademark
of Baylis Medical Company Inc.
in the United States of America and/or other countries.
English
Carefully read all instructions prior to use. Observe all contraindications, warnings and
precautions noted in these instructions. Failure to do so may result in patient complications.
Caution:
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Notice (EU):
Any serious incident as defined in the EU Medical Device Regulation (2017/745)
that has occurred in relation to the RFP-100A Footswitch should be reported to Baylis Medical
Company Inc. and the competent authority of the EU Member State in which the physician and/or
patient is established.
I.
DEVICE DESCRIPTION
The RFP-100A Footswitch (Footswitch) is used with the RFP-100A Baylis Medical Company
Radiofrequency Puncture Generator (RFP-100A Generator) for RF energy delivery. The
Footswitch is provided with redundant micro switches and is used as an alternative to the RF
On/Off button on the RFP-100A Generator for RF energy delivery.
II.
INDICATIONS FOR USE
The Footswitch is to be used with the RFP-100A Generator.
III.
CONTRAINDICATIONS
The Footswitch is not recommended for uses other than the indicated use. The RFP-100A
Generator Instructions for Use should be consulted for any other contraindications that may be
associated with use of the RFP-100A Generator.
IV.
WARNINGS
•
Only physicians with a thorough understanding of radiofrequency powered puncture
procedures should use this device.
•
Do not alter this device in any way.
•
The Footswitch must be used with the RFP-100A Generator only. Attempts to use it with
other radiofrequency puncture generators can result in serious electrical injury of the
patient and/or operator.
V.
PRECAUTIONS
•
Do not attempt to use the Footswitch before thoroughly reading the accompanying
Instructions for Use and RFP-100A Generator Instructions for Use manual.
•
Visually inspect the Footswitch prior to use. Do not use the Footswitch if there is any
damage.
•
Regularly inspect and maintain the Footswitch according to section VII. and X.
VI.
ADVERSE EVENTS
The RFP-100A Generator Instructions for Use should be consulted for any adverse events.
VII.
INSPECTION PRIOR TO USE
Prior to use all the individual components including the RFP-100A Generator and the Footswitch
should be carefully examined for damage or defects, as should all equipment used in the
procedure. Do not use defective equipment.
VIII.
DIRECTIONS FOR USE
The Footswitch serves as an actuator for the connected device. When connected to the RFP-
100A Generator, the Footswitch can be used as an alternative to the RF ON/OFF button on the
RFP-100A Generator to activate or terminate RF energy delivery.
For Footswitch procedure and connections to the RFP-100A Generator please refer to the RFP-
100A Generator Instructions for Use manual.
IX.
CLEANING INSTRUCTIONS
The outer surface of the Footswitch may be cleaned with a mild soapy solution. DO NOT
immerse the Footswitch in any liquid. Avoid caustic or abrasive cleaners. If disinfecting is
required, 70% isopropyl alcohol or 5% solution of household bleach may be used to clean the
outer surfaces. The Footswitch cannot be sterilized.
X.
MAINTENANCE
Regular checks or maintenance is recommended according to ambient conditions and
application frequency:
Check actuating elements for mechanical function. To perform this test, disconnect the
footswitch from RFP-100A Generator. Press on the footswitch and release force. Confirm that
the footswitch returns to its rest position (released state).
Check housing and connecting cable for damage and harmful dirt.
XI.
DISPOSAL OF WASTE
The Footswitch is reusable. However, when the Footswitch is determined to be unusable,
dispose of the Footswitch in compliance with standard hospital procedures.
XII.
CUSTOMER SERVICE AND PRODUCT RETURN INFORMATION
If you have any problems with or questions about Baylis Medical Equipment contact our
technical support personnel.
NOTES:
1.
In order to return products you must have a return authorization number before shipping
the products back to Baylis Medical Company.
2.
Baylis Medical will not accept any piece of used equipment without a sterilization
certificate. .
XIII.
LABELING AND SYMBOLS
Manufacturer
Consult
Instructions
for Use
Medical Device
Model
number
Caution
Serial
Number
Only for EU member states:
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
Federal (U.S.A.) law restricts this device to sale by or on
the order of a physician.
Date of
Manufacture
Footswitch
EU Authorized Representative
Use with: BMC RFP-100A generators
only
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: (514) 488-9801/ (800) 850-9801 Fax: (514)
488-7209
www.baylismedical.com
EU Authorized Representative:
Quality First International OÜ
Laki 30, 12915 Tallinn
Estonia
Telephone: +372 610 41 96
Email: [email protected]
Instructions for Use
RFP-100A Footswitch