Baylis Medical Company
Reusable RFP-100A Connector Cable Instructions for Use
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Instructions for Use Reusable RFP-100A Connector Cable English... Français... Español... Português... Nederlands... Italiano... Deutsch... Čeština... Dansk... Suomo... Norsk... Svenska...
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Baylis Medical Company Inc. 5959 Trans-Canada Highway Montreal, Quebec, Canada, H4T 1A1 Tel: (514) 488-9801/ (800) 850-9801 Fax: (514) 4887209 www.baylismedical.com EU Authorized Representative: Quality First International OÜ Laki 30, 12915 Tallinn Estonia Telephone: +372 610 41 96 Email: [email protected]
© Copyright Baylis Medical Company Inc., 2009-2022 Baylis Medical and the Baylis Medical logo are trademarks of Baylis Medical Technologies Inc. All other trademarks or registered trademarks are property of their respective owners.
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. I. DEVICE DESCRIPTION The Reusable RFP-100A connector cable connects the Baylis Medical Company RFP-100A Radiofrequency Puncture Generator (RFP-100A Generator) to Baylis Medical approved radiofrequency puncture devices. This Cable enables radiofrequency (RF) power to be delivered from the Generator to the puncture device. Detailed information concerning the RFP-100A Generator is contained in a separate manual that accompanies the Generator (RFP-100A Generator Instructions for Use). In addition, detailed information concerning the RF puncture devices is contained in separate manuals that accompany these devices. The dimensions for the Reusable RFP-100A connector cable can be found on the device label and in section VII “Product Specifications.” The Reusable RFP-100A connector cable has a four-pin connector on one end that mates with the RFP100A Generator and a connector at the other end, which mates with the puncture device. II. INDICATIONS FOR USE The intended use of the Reusable RFP-100A connector cable is to connect the RFP-100A Generator to Baylis Medical approved puncture devices (RF puncture devices).
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III. CONTRAINDICATIONS The Reusable RFP-100A connector cable is not recommended for use with any other RF generator or any other device. IV. WARNINGS • The Reusable RFP-100A connector cable is a reusable device. Only use the validated cleaning and sterilization methods as described in section XI “Cleaning and Sterilization Instructions” to clean and sterilize the Connector Cable. No other cleaning and sterilization methods have been tested. Failure to properly clean and sterilize the device can cause patient injury and/or the communication of infectious disease(s) from one patient to another. • The Reusable RFP-100A connector cable must only be used with the RFP100A Generator and RF puncture devices. Attempts to use it with other RF Generators and devices can result in electrocution of the patient and/or operator. • Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency puncture procedures due to the continuous usage of fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure. V. PRECAUTIONS • Do not attempt to use the Reusable RFP-100A connector cable or ancillary equipment before thoroughly reading the accompanying Instructions for Use. • Puncture procedures should be performed only by physicians thoroughly trained in the techniques of radiofrequency powered puncture in a fully equipped catheterization laboratory. • The sterile packaging should be visually inspected prior to use to detect any compromise. Ensure that the packaging has not been damaged. Do not use the equipment if the packaging has been compromised. • Visually inspect the cable to ensure there is no cracking or damage to the insulating material. Do not use the cable if there is any damage. • The Reusable RFP-100A connector cable is intended for use with RF puncture devices only. • Never disconnect the Reusable RFP-100A connector cable from the RFP100A Generator while the Generator is delivering RF power. • Never disconnect the Reusable RFP-100A connector cable from the RFP100A Generator by pulling on the cable. Failure to disconnect the cable properly may result in damage to the cable. • Do not twist the Reusable RFP-100A connector cable while inserting or removing it from the Isolated Patient Connector on the Generator. Twisting the cable may result in damage to the pin connectors. • Do not bend the cable. Excessive bending or kinking of the cable may damage the integrity of the cable and may cause patient injury. Care must be taken when handling the cable. • Take precautions to limit the effects that the electromagnetic interference (EMI) produced by the Generator may have on the performance of other equipment. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the Generator. • Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during radiofrequency power applications. • During power delivery, the patient should not be allowed to come in contact with ground metal surfaces. • In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application. Baylis Medical Company relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of the Baylis Medical Radiofrequency Puncture System. VI. ADVERSE EVENTS Adverse events associated with the use of this device are similar to those indicated for the Baylis Medical Radiofrequency Puncture System. VII. PRODUCT SPECIFICATIONS Model Number Strain Relief Colour Overall Useable Length Generator Connector Device Connector
RFX-BAY-TS Black at device end, blue at generator end 10 feet (3m) 4-pin (Plug) 4-pin (receptacle)
VIII. INSPECTION PRIOR TO USE Perform the following checks before the patient is presented for the procedure. These tests will allow you to verify that the equipment you will use is in proper working order. Do these tests in a sterile environment. Do not use defective equipment. KEY ITEMS
QUESTION?
Sterility
Is the connector cable sterile?
Visual Check
Have you done a visual check on the entire system?
WARNINGS AND EXPLANATIONS The Reusable RFP-100A connector cable is supplied sterile for its initial use. Inspect the packaging to ensure the package has not been damaged and sterility has not been compromised. Prior to each subsequent use it must be cleaned and sterilized.
Ensure connectors and the cable have no visible damage, such as discoloration, cracks, label fading, cable splice, or kinks. Do not use damaged equipment.
IX. EQUIPMENT REQUIRED Puncture procedures should be performed in a specialized clinical setting which may be equipped with a fluoroscopy unit, radiographic table, physiologic recorder, emergency equipment and instrumentation for gaining vascular access. X. DIRECTIONS FOR USE Once the RF puncture device is properly positioned at the puncture site, and the Generator is properly set up (following the instructions in the RFP-100A Generator
DMR RFX 3.3 V-12 15-Sep-2022
Instructions for Use), the Reusable RFP-100A connector cable can be used to connect the catheter or wire to the Generator. 1. Connect the generator connector end of the cable to the isolated patient connector port on the RFP-100A Generator as per the Generator Instructions for Use. The generator connector end of the cable can be identified by the blue strain relief (the device connector end has a black strain relief). The Reusable RFP-100A connector cable uses a circular connector, keyed for proper alignment. Gently line up the connector pins with the socket and push in until the connector fits firmly into the socket. Any attempt to connect the cable otherwise will damage the pins on the connector. 2. Do not use excessive force in connecting the cable to the generator. Use of excessive force may result in damage to the connector pins. 3. Connect the device connector end of the cable to the RF Puncture Device. The Reusable RFP-100A connector cable uses a circular connector, keyed for proper alignment. Gently line up the connector pins with the RF Puncture Device connector and push in until the connector fits firmly into the plug. 4. To disconnect the puncture device from the Connector Cable: Firmly grasp the catheter connector (receptacle) end of the cable in one hand and gently pull it straight out of the device connector. 5. To disconnect the cable from the generator, grasp the connector firmly and gently pull it straight out of the socket.
PROBLEM Generator Alert Messages
COMMENTS In order to successfully puncture tissue using radiofrequency energy, the entire system must be connected and all devices must be in good working order.
Connector Cable does not fit into the Isolated Patient Connector on the front panel of the generator
The connectors are designed to connect in a specific way for safety reasons. If the connector “keys” are out of line, the connectors won’t fit together
XI. CLEANING AND STERILIZATION INSTRUCTIONS DANGER The Reusable RFP-100A Connector Cable is supplied sterile, however it must be cleaned and sterilized before each subsequent use as described in this Instructions for Use document. Failure to properly clean and sterilize the device can cause patient injury and/or the communication of infectious diseases from one patient to another. IMPORTANT The manufacturer recommends the user follow a quality control program for each sterilization cycle that meets or exceeds American Operating Room Nurses (AORN) Standards, Recommended Practices & Guidelines - 2000. This program includes, but is not limited to recording: • Type of sterilizer and cycle used • Lot control number • Load contents • Exposure time and temperature, if not provided by a recording chart • Operator’s name • Results of sterilization process monitoring (i.e. chemical, mechanical, biological) Cleaning and Decontamination 1. Ensure that blood and other contaminates do not dry on the Reusable RFP100A connector cable. 2. Visually inspect the cable for defect. 3. Rinse the cable with de-ionized water until colourless run-off water occurs. Once the water runs clear, soak the cable (except for the connectors at the ends of the cable) in de-ionized water at 22°C-48°C for 1 minute. Remove the cable from the water and scrub it with a soft bristle brush until it is visually clean. Note: Do not let the connectors soak. Wipe them as necessary until they are visually clean. 4. Soak the cable (except for the connectors) in an enzymatic cleaning solution (such as Terg-A-Zyme) for 20 minutes. Ensure that the temperature of the solution is below 55°C. Scrub again with a soft bristle brush, and rinse thoroughly using de-ionized water until all traces of detergent residue are removed. 5. Visually inspect the parts for debris. If any is present repeat steps 3 and 4. 6. Dry the cable with a clean, dry, lint free towel. 7. Place the cable on a sterilization tray. 8. Consult referenced standards for proper packaging and storage of sterilized product. Sterilization For a prevacuum sterilizer: WRAPPED: 132°C-135°C (270°F-275°F) FOR 3-4 MIN. UNWRAPPED: “FLASH’ STERILIZATION 132°C FOR 4 MIN. NOTE: Only the above cleaning and sterilization methods have been validated for the Reusable RFP-100A connector cable. Single Use RFP-100A connector cables are not meant for re-sterilization. No other cleaning and sterilization methods have been tested. Failure to follow these instructions can cause patient injury and/or the communication of infectious disease(s) from one patient to another. 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. Ensure that any product being returned to Baylis Medical has been cleaned, decontaminated and sterilized as per user instructions before returning it for warrantied service. XIII. TROUBLESHOOTING The following table is provided to assist the user in diagnosing potential problems.
XIV.
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TROUBLESHOOTING Ensure that all connections are made: - puncture device to connector cable - connector cable to generator - generator to power outlet - generator to grounding pad Visually inspect the catheter/wire or cable for damage. Immediately discard any damaged equipment. If the problem persists discontinue use. For error/alert messages encountered while attempting puncture, refer to the operator’s manual that accompanies the Generator. If errors persist, attach a new connector cable. If this solves the problem, discard the damaged connector cable. Check that the connector keys are lined up in the proper orientation. Ensure that the connectors are clean and unobstructed.
LABELING AND SYMBOLS Manufacturer
Use By
Consult Instructions for Use
Caution
Model number
Lot Number
Sterile using ethylene oxide
Keep Away From Sunlight
Do Not Use if Packaging is Damaged
EU Authorized Representative
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. 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
XV. LIMITED WARRANTY – Disposables and Accessories Baylis Medical Company Inc. (BMC) warrants its Disposable and Accessory products against defects in materials and workmanship. BMC warrants that sterile products will remain sterile for a period of time as shown on the label as long as the original package remains intact. Under this Limited Warranty, if any covered product is proved to be defective in materials or workmanship, BMC will replace or repair, in its absolute and sole discretion, any such product, less any charges to BMC for transportation and labor costs incidental to inspection, removal or restocking of product. The length of the warranty is: (i) for the Disposable products, the shelf life of the product, and (ii) for the Accessory products, 90 days from shipment date. This limited warranty applies only to new original factory delivered products that have been used for their normal and intended uses. BMC’s Limited Warranty shall not apply to BMC products which have been resterilized, repaired, altered, or modified in any way and shall not apply to BMC products which have been improperly stored or improperly cleaned, installed, operated or maintained contrary to BMC’s instructions. DISCLAIMER AND LIMITATION OF LIABILITY THE LIMITED WARRANTY ABOVE IS THE SOLE WARRANTY PROVIDED BY SELLER. SELLER DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. THE REMEDY SET FORTH HEREIN SHALL BE THE EXCLUSIVE REMEDY FOR ANY WARRANTY CLAIM, AND ADDITIONAL DAMAGES, INCLUDING CONSEQUENTIAL DAMAGES OR DAMAGES FOR BUSINESS INTERRUPTION OR LOSS OF PROFIT, REVENUE, MATERIALS, ANTICIPATED SAVINGS, DATA, CONTRACT, GOODWILL OR THE LIKE (WHETHER DIRECT OR INDIRECT IN NATURE) OR FOR ANY OTHER FORM OF INCIDENTAL, OR INDIRECT DAMAGES OF ANY KIND, SHALL NOT BE AVAILABLE. SELLER'S MAXIMUM CUMULATIVE LIABILITY RELATIVE TO ALL OTHER CLAIMS AND LIABILITIES, INCLUDING OBLIGATIONS UNDER ANY INDEMNITY, WHETHER OR NOT INSURED, WILL NOT EXCEED THE COST OF THE PRODUCT(S) GIVING RISE TO THE CLAIM OR LIABILITY. SELLER DISCLAIMS ALL LIABILITY RELATIVE TO GRATUITOUS INFORMATION OR ASSISTANCE PROVIDED BY, BUT NOT REQUIRED OF SELLER HEREUNDER. ANY ACTION AGAINST SELLER MUST BE BROUGHT WITHIN EIGHTEEN (18) MONTHS AFTER THE CAUSE OF ACTION ACCRUES. THESE DISCLAIMERS AND LIMITATIONS OF LIABILITY WILL APPLY REGARDLESS OF ANY OTHER CONTRARY PROVISION HEREOF AND REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY) OR OTHERWISE, AND FURTHER WILL EXTEND TO THE BENEFIT OF SELLER'S VENDORS, APPOINTED DISTRIBUTORS AND OTHER AUTHORIZED RESELLERS AS THIRD-PARTY BENEFICIARIES. EACH PROVISION HEREOF WHICH PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF WARRANTY OR CONDITION OR EXCLUSION OF DAMAGES IS SEVERABLE AND INDEPENDENT OF ANY OTHER PROVISION AND IS TO BE ENFORCED AS SUCH. IN ANY CLAIM OR LAWSUIT FOR DAMAGES ARISING FROM ALLEGED BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, PRODUCT LIABILITY OR ANY OTHER LEGAL OR EQUITABLE THEORY, THE BUYER SPECIFICALLY AGREES THAT BMC SHALL NOT BE LIABLE FOR DAMAGES OR FOR LOSS OF PROFITS, WHETHER FROM BUYER OR BUYER’S CUSTOMERS. BMC’S LIABILITY SHALL BE LIMITED TO THE PURCHASE COST TO BUYER OF THE SPECIFIED GOODS SOLD BY BMC TO BUYER WHICH GIVE RISE TO THE CLAIM FOR LIABILITY.
DMR RFX 3.3 V-12 15-Sep-2022