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CEDTC100
Instructions for Use
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Medtronic CEDTC100 Instructions for Use

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DiamondTemp™
Catheter-to-RF Generator Cable
Instructions for Use
Caution: Investigational device. Limited by Federal law (USA) to investigational use.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
DiamondTemp™

Contents

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1 Glossary of symbols

The following table defines symbols that are used on packaging and product labeling. Refer to the labels to determine which symbols apply to this product and for the product-specific information, such as the date of manufacture.
Symbol
Standard/Standard Title or Reference
21 CFR 801.109
a
Symbol Title/Reference Number Explanatory Text
Prescription only USA Federal law restricts
this device to sale by or on the order of a licensed healthcare practitioner.
EN 50419
b
Recycle: Electronic Equip-
Do NOT throw in trash.
ment
ISO 15223-1
d
Consult instructions for use (clause 5.4.3)
Indicates the need for the user to consult the instruc­tions for use at this website: www.medtronic.com/man­uals
IEC 60601-1
ISO 15223-1
c
d
Follow instructions for use (Table D2, Symbol 10)
Date of manufacture (clause 5.1.3)
Refer to instruction man­ual/booklet (blue symbol).
Indicates the date when the medical device was manu­factured
ISO 15223-1
d
Catalog number (clause 5.1.6)
Indicates the manufactur­er’s catalog number so the device can be identified
ISO 15223-1
d
Batch code (clause 5.1.5)
Indicates the manufactur­er’s batch code so that the batch or lot can be identified
ISO 15223-1
d
Use by (clause 5.1.4)
Indicates the date after which the device is not to be used
ISO 15223-1
ISO 15223-1
d
d
Manufacturer (clause 5.1.1)
Keep Dry (clause 5.3.4)
Indicates the medical device manufacturer
Indicates a medical device that needs to be protected from moisture
ISO 15223-1
d
Do not use if package is damaged (clause 5.2.8)
Indicates a medical device that should not be used if the package has been dam­aged or opened
ISO 15223-1
d
Sterilized using ethylene oxide (clause 5.2.3)
Indicates a medical device that has been sterilized using ethylene oxide
N/A N/A Device can be re-sterilized
for the number of times indi­cated
ISO 15223-1
d
Temperature limit (clause 5.3.7)
Indicates the temperature limits to which the medical device can be safely exposed
N/A Storage temperature limit Indicates the required tem-
perature range for storing the device
N/A Transit temperature limit Indicates the required tem-
perature range for trans­porting the device
ISO 15223-1
d
Humidity limitation (clause 5.3.8)
Indicates the range of humidity to which the medi­cal device can be safely exposed
ISO 15223-1
d
Atmospheric pressure limi­tation
Indicates the range of atmospheric pressure to
(clause 5.3.9)
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Symbol
Standard/Standard Title or Reference
Symbol Title/Reference Number Explanatory Text
which the medical device can be safely exposed
N/A Package contents Indicates the components
included in the device pack­age
N/A Catheter-to-RFG cable Indicates that a cable is
included in the device pack­age
ISO 7000
e
Product documentation (symbol 0419)
Indicates that product doc­umentation is included in the device package
ISO 15223-1
d
Sterile barrier
Single sterile barrier system
(clause 5.2.13)
a
21 CFR 801.109: United States Code of Federal Regulations, Title 21, Food and Drugs
b
EN 50419: Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
c
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
d
ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied
e
ISO 7000: Graphical symbols for use on equipment

2 Device description

The Medtronic DiamondTemp catheter-to-RF generator (RFG) cable is part of the DiamondTemp ablation system, which also includes the DiamondTemp ablation catheter, DiamondTemp RF generator, DiamondTemp irrigation tubing set, DiamondTemp GenConnect cable, DiamondTemp EGM cable, and DiamondTemp irrigation pump.
The DiamondTemp ablation system is designed to deliver radiofrequency (RF) energy to the cardiac anatomy via the DiamondTemp catheter.
The Model CEDTC100 catheter-to-RFG cable is used to connect the DiamondTemp catheter to the RF generator. The distal end of the cable has a 19-pin connector that connects to the DiamondTemp catheter. The proximal end of the cable has a 26-pin connector that connects to the RF generator. The length of the cable is 2.5 m (8.2 ft).

3 Indications for use

The DiamondTemp catheter-to-RF generator cable is designed for use with the DiamondTemp ablation system. The cable provides connection between the DiamondTemp generator and the DiamondTemp catheter. Refer to the DiamondTemp catheter instructions for the indications for use. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with the DiamondTemp catheter before using the cable.

4 Contraindications

The contraindications listed in the DiamondTemp catheter instructions apply to the use of the DiamondTemp catheter-to-RFG cable. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with the DiamondTemp catheter before using the catheter-to-RFG cable.

5 Warnings and precautions

• Refer to the DiamondTemp catheter instructions for warnings and precautions related to the use of the DiamondTemp ablation system.
• Do not expose the cable to organic solvents.
• The cable is designed for use with the DiamondTemp catheter and generator only.
• Use of improper cables may cause errors in the operation of the generator and can result in hazards to the patient.
• The cable is supplied sterile, by ethylene oxide (EtO). Do not use if the sterile barrier is damaged. Use of non-sterile devices may result in patient injury.
• Use the cable before the “Use By” date on the device package. Do not use past the “Use By” date regardless of the number of times the cable has been resterilized.
• Do not pull on the cable to disconnect the cable from either the RF generator or the catheter.
• Sterilize after use; do not reuse without sterilizing. The cable may be resterilized up to ten (10) times via Autoclave sterilization (see section 9). Do not reuse more than ten times. Reusing the cable more than ten times may lead to device malfunction, resulting in failure to complete the procedure or possibly patient injury.
• Store in a cool, dry place.
• Before use, inspect the cable and packaging to verify that no damage has occurred. Do not use if the cable or packaging is damaged.
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• All devices that are connected to the RF generator must be safe for patients per specifications in IEC 60601-1 and IEC 60601-2-2. Improper use may be dangerous for the patient.
• Position connecting cables to avoid contact with the patient and other electrical leads.
• If used in the presence of other electrical equipment, noise could be introduced into the cable. Position the cable as far away as possible from sources of potential electromagnetic interference.
• Do not clean the cable by using automated cleaning processes.
• Do not immerse the cable connectors in fluids.

6 Potential adverse events

The potential adverse events that may be associated with ablation procedures can vary greatly in frequency and severity and may necessitate additional medical intervention, including surgery. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each DiamondTemp catheter, before using the DiamondTemp ablation system.

7 Directions for use

Note: Refer to the DiamondTemp catheter instructions for use and DiamondTemp RF generator user manual for
detailed operating instructions of the DiamondTemp ablation system.
1. Carefully remove the sterile cable from its packaging using standard hospital practices. Inspect the cable for damage or rough surfaces, sharp edges, or protrusions before use. Connect the sterile cable to the sterile catheter. To do this, align the blue strain-relief end of the catheter-to-RFG cable connector key to the catheter receptacle key, and then push the connector into the catheter receptacle firmly until it stops. Do not force connectors or pin damage can occur. To disconnect, pull the connector body until it separates from the receptacle.
2. Pass the RF generator end of the cable out of the sterile field.
3. Connect the cable to the generator or GenConnect cable. To do this, align the green strain-relief end of the catheter-to-RFG cable connector key to the generator or catheter-to-RFG receptacle key, and then push the connector into the receptacle firmly until it stops. Do not force connectors or pin damage can occur. To disconnect, pull the connector body until it separates from the receptacle.
4. Refer to the connectivity diagrams in Figure 1 and Figure 2. Figure 1 illustrates how to connect the cable to the catheter and directly to the RF generator. Figure 2 illustrates how to connect the cable to operate the catheter and system in conjunction with a compatible mapping and navigation system (such as the Abbott EnSite™ system). Refer to the respective instructions for detailed information.
5. Connect the DIP electrode directly to the generator.

Figure 1. Connectivity diagram between catheter and RF generator

1 RF generator 2 26-pin male connector to RF generator 3 DiamondTemp cath-to-RFG cable
4 19-pin male connector to DiamondTemp ablation
catheter
5 DiamondTemp ablation catheter
6

Figure 2. Connectivity diagram between catheter and RF generator when using a mapping and navigation system

1 DiamondTemp ablation catheter 2 Catheter-to-RFG cable 3 9-pin quick connector 4 GenConnect cable 5 DiamondTemp RF generator
Verify that the generator does not show any errors or warnings. When used with a mapping and navigation system, follow the respective instructions to confirm correct operation. Construct an anatomic map of the region of interest only after all mapping catheters, the DiamondTemp catheter, and all respective cables and neutral electrodes (including the ablation return pad) are completely and properly connected. The addition of catheters or electrodes may lead to inaccurate anatomic maps and may require re-mapping.
6 Ablation return pad 7 14-pin twist connector 8 GenConnect box (oriented upside down, for
purposes of illustration)
9 Amplifier

8 Device removal and disposal

Disconnect the cable from the generator by gently pulling on the outer housing of the RF generator connector. Do not pull on the cabling, as this may damage the cable or the generator.
After cleaning or decontamination, the cable may be resterilized and reused up to ten times or disposed of according to standard procedures for electrical cables and in accordance with local laws and regulations.

9 Cleaning

The cable should be cleaned by wiping with enzymatic concentrates, such as Prolystica 2x Concentrate, at 1/8 oz per gallon of tap water (0.94 g per 1 L).
1. If soiling is present on the external portion of the connector previously shielded by the receptacle, use clean, lint-free cloths to dip into the prepared detergent solution and wipe the area until all visible soil is removed.
2. Apply Parafilm over the connectors at both ends of the cable.
3. Use clean, lint-free cloths to dip into the prepared solution and wipe the cable until all visible soil is removed.
4. Thoroughly rinse the cable with reverse osmosis/deionized (RO/DI) water for a minimum of 30 s, ensuring the connectors remain dry.
5. Dry the cable with a clean, lint-free cloth. Remove the Parafilm.
6. Visually inspect each cable to ensure there is no visible soil.
Note: The cable connectors should not be immersed in fluids. Automated cleaning of the cable is not recommended.

10 Resterilization

The cable may be resterilized for reuse up to ten times. Medtronic recommends using autoclave sterilization methods. If using autoclave sterilization, the following method is recommended:
• Double wrap individual cables in sterile wraps.
• Condition using a prevacuum cycle of 4 pulses.
• Sterilize at 134°C for 3 to 18 min.
• Dry for 30 min.
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11 How supplied

The cable is supplied separately from the generator, along with the required product documentation. The contents are sterile if the packaging is unopened and undamaged at the time of use. If the packaging is damaged, do not use the product and contact a Medtronic representative.

12 Storage

13 Limited warranty

The following Limited Warranty applies to customers within the United States only:
A. This Limited Warranty provides the following assurance to the purchaser of a Medtronic DiamondTemp catheter-to-RFG cable, hereafter referred to as Product:
(1) Should the Product fail to function within normal tolerances due to a defect in materials or workmanship on or before its “Use By” or "Use Before" date, Medtronic will at its option: (a) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A(2), against the purchase of the replacement product or (b) provide a functionally comparable replacement product at no charge.
(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or replacement product.
B. To qualify for this Limited Warranty, these conditions must be met:
(1) The Product must be used on or before its “Use By” or "Use Before" date.
(2) The Product must be returned to Medtronic within 60 days and shall be the property of Medtronic.
(3) The Product must be used in accordance with the labeling and not altered or subjected to misuse, abuse, accident, or improper handling.
C. This Limited Warranty is limited to its express terms. In particular:
(1) Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE Product, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.
(2) This Limited Warranty is made only to the purchaser of the Product.
AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM, OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.
(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights which vary from state to state.
(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this Limited Warranty. This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty.
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Medtronic, Inc.
*M005671C001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
© 2021 Medtronic M005671C001 A 2021-02-02
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