Medtronic CEDTGC100 Instructions for Use
DiamondTemp™
GenConnect Cable
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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
1 Glossary of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
7 Directions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
8 Device removal and disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
9 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
10 How supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
11 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
12 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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 Symbol title/Reference number Explanatory text
ISO 15223-1
21 CFR 801.109
EN 50419
d
a
b
Consult instructions for use
(clause 5.4.3)
Prescription only USA Federal law restricts this device to sale by or on
Consult instructions for use at this website:
www.medtronic.com/manuals
the order of a licensed healthcare practitioner.
Recycle: Electronic Equipment Do NOT throw in trash.
IEC 60601-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
c
d
d
d
d
d
d
d
Follow instructions for use
(Table D2, Symbol 10)
Catalog number
(clause 5.1.6)
Batch code
(clause 5.1.5)
Manufacturer
(clause 5.1.1)
Date of manufacture
(clause 5.1.3)
Keep Dry
(clause 5.3.4)
Do not use if package is damaged
(clause 5.2.8)
Temperature limit
(clause 5.3.7)
N/A Storage temperature limit Indicates the required temperature range for storing
N/A Transit temperature limit Indicates the required temperature range for trans-
ISO 15223-1
ISO 15223-1
d
d
Humidity limitation
(clause 5.3.8)
Atmospheric pressure limitation
(clause 5.3.9)
N/A Package contents Indicates the components included in the device
N/A GenConnect cable Indicates that a GenConnect cable is included in the
e
ISO 7000
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
Product documentation
(symbol 0419)
Refer to instruction manual/booklet (blue symbol)
Indicates the manufacturer’s catalog number so the
device can be identified
Indicates the manufacturer’s batch code so that the
batch or lot can be identified
Indicates the medical device manufacturer
Indicates the date when the medical device was
manufactured
Indicates a medical device that needs to be protected from moisture
Indicates a medical device that should not be used if
the package has been damaged or opened
Indicates the temperature limits to which the medical
device can be safely exposed
the device
porting the device
Indicates the range of humidity to which the medical
device can be safely exposed
Indicates the range of atmospheric pressure to which
the medical device can be safely exposed
package
device package
Indicates that product documentation is included in
the device package
2 Device description
The Medtronic DiamondTemp GenConnect cable is part of the DiamondTemp ablation system, which also includes the DiamondTemp ablation catheter, DiamondTemp RF generator,
DiamondTemp irrigation tubing set, DiamondTemp catheter-to-RF generator (RFG) 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 distal end of the nonsterile GenConnect cable (model CEDTGC100) has a 26-pin female connector that connects to the catheter-to-RFG cable and the proximal end has a 26-pin male
connector that connects to the generator. The length of the cable is 1.8 m (6.0 ft).
3
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