Baylis RFP-100A

To Next Page

To Previous Page

PREFACE

For the user’s convenience, the Baylis Medical Company Inc. (BMC, or “Baylis Medical”)

Radiofrequency Puncture Generator (model: RFP-100A) will be referred to in this Operator’s

Manual as the “Generator”. The Generator is to be used only with BMC radiofrequency (RF)

devices that have been separately cleared for use with the Generator. These separately cleared

BMC radiofrequency devices include, but are not limited to, the Nykanen Radiofrequency Wire,

the PowerWire

Radiofrequency Guidewire, the NRG

Transseptal Needle, and the VersaCross

Radiofrequency Wire - they will generally be referred to in this Operator’s Manual as the “BMC

RF Device”. The BMC RF Device is connected to the Generator through the appropriate BMC

connector cable. The DuoMode

Cable serves as an extension cable that is used with the

Generator, BMC RF devices and diagnostic equipment. The footswitch is an accessory to the

BMC Radiofrequency Puncture Generator.

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.

User specifically agrees that Baylis Medical shall not indemnify the Buyer for claims resulting in

damages, personal injury or death if the RF Generator is used in conjunction or with any

unauthorized products, items, consumables, disposables, equipment orparts.

User will not resell or redistribute the Generator to entities or persons, except with Baylis

Medical’s prior written consent.

The use of the BMC Radiofrequency Puncture Generator is fully described in this manual,

including a description of the Generator, its controls, displays, and a sequence for its operation.

In addition, other information of importance to the user is supplied. For specific instructions

pertaining to the use of any one of the separately cleared BMC RF Devices, please refer to the

instructions for use for the respective BMC RF Device.

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Baylis RFP-100A - Preface