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CEDTTS100
Instructions for Use
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Medtronic CEDTTS100 Instructions for Use

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DiamondTemp™
Irrigation Tubing Set
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

2 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4 Principle of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
8 Directions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
9 Device disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
10 How supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
11 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
12 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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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 Symbol title/Reference number Explanatory text
21 CFR 801.109
IEC 60601-1
EN 50419
ISO 7000
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
N/A Manufactured in/ manufacturing site Indicates where the device was manufac-
N/A Storage temperature limit Indicates the required temperature range for
N/A Transit temperature limit Indicates the required temperature range for
ISO 15223-1
N/A Package contents Indicates the components included in the
ISO 15223-1
N/A Irrigation tubing Indicates that tubing is included in the device
ISO 7000
ISO 15223-1
a
21 CFR 801.109: United States Code of Federal Regulations, Title 21, Food and Drugs
b
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
c
EN 50419: Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
d
ISO 7000: Graphical symbols for use on equipment
e
ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied
a
b
c
d
e
e
e
e
e
e
e
e
e
e
e
e
Prescription only USA Federal law restricts this device to sale by
Follow instructions for use (Table D2, Symbol 10)
or on the order of a licensed healthcare prac­titioner.
Refer to instruction manual/booklet (blue sym­bol).
Recycle: Electronic Equipment Do NOT throw in trash.
Defibrillation Proof Type CF Applied Part (symbol 5336)
Sterilized by ethylene oxide treatment (clause 5.2.3)
Catalog number (clause 5.1.6)
Batch code (clause 5.1.5)
Date of manufacture (clause 5.1.1)
Use by (clause 5.1.4)
Manufacturer (clause 5.1.1)
Keep Dry (clause 5.3.4)
Do not reuse (clause 5.4.2)
Do not re-sterilize (clause 5.2.6)
Do not use if package is damaged (clause 5.2.8)
Temperature limit (clause 5.3.7)
Consult instructions for use (clause 5.4.3)
To identify a defibrillation-proof type CF applied part complying with IEC 60601-1.
Indicates a medical device that has been steri­lized using ethylene oxide.
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 date when the medical device was manufactured.
Indicates the date after which the device is not to be used.
Indicates the medical device manufacturer.
Indicates a medical device that needs to be protected from moisture.
Indicates a medical device that is intended for one use or for use on a single patient during a single procedure.
Indicates a medical device that is not to be resterilized.
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.
Indicates the need for the user to consult the instructions for use at this website: www.medtronic.com/manuals
tured.
storing the device.
transporting the device.
e
Humidity limitation (clause 5.3.8)
Indicates the range of humidity to which the medical device can be safely exposed.
device package.
e
d
e
Atmospheric pressure limitation (clause 5.3.9)
Product documentation (symbol 0419)
Sterile barrier (clause 5.2.11)
Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
package. Indicates that product documentation is inclu-
ded in the device package.
Single sterile barrier system.
.
.

2 Device description

The Medtronic DiamondTemp irrigation tubing set is part of the DiamondTemp ablation system, which also includes the DiamondTemp ablation catheter, DiamondTemp RF generator (RFG), DiamondTemp catheter-to-RF generator cable, 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 DiamondTemp Model CEDTTS100 irrigation tubing set consists of the following components (Figure 1). The length of the tubing set assembly is 3.66 m ± 5.08 cm (144 in ± 2 in).
• A drip chamber with an intravenous (IV) spike for connection to an IV bag
• A pump head section with plastic retention clips that fit the slots for the air-bubble detectors (located inside the irrigation pump)
• An electrostatic discharge (ESD) pink sleeve that reduces electrogram artifacts caused by the peristaltic motion tribo-charge
• A catheter end that terminates in a standard luer lock connector and connects to the DiamondTemp catheter
• A 3-way stopcock (not shown)
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Figure 1. Tubing Set Components

1 - Catheter Luer 2 - Pump Head Section
3 - Drip Chamber with IV Spike

3 Indications for use

The DiamondTemp irrigation tubing set is designed for use with the DiamondTemp ablation system. 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 tubing set.

4 Principle of operation

The tubing set delivers saline (0.9%) with Heparin at 1 IU/mL to the catheter when used with the irrigation pump. The delivery action is based on a peristaltic mechanism employing rollers and mechanical fingers that push fluid through the tubing.
The tubing set is supplied sterile and is for single-use only.

5 Contraindications

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

6 Warnings and precautions

• Refer to the DiamondTemp catheter instructions for warnings and precautions related to the use of the DiamondTemp ablation system.
• The tubing set is designed for use with the DiamondTemp irrigation pump only.
• The tubing set is designed for use with the DiamondTemp catheter only.
• The tubing set includes an ESD pink sleeve, which is specially designed to minimize the noise that may be induced on electrograms by the tribo-charge caused by the pump head peristaltic motion. The irrigation pump should not be used with tubing other than that provided by Medtronic.
• The tubing set is designed for use with only heparinized normal saline solution. Specified flow rate accuracy may not be maintained when used with incompatible fluids or delivery devices.
• Use of fluid extension lines with the DiamondTemp irrigation tubing set may cause errors in the operation of the irrigation pump and can result in improper irrigation or air induction into the patient.
• It is the responsibility of hospital personnel to monitor and track the total saline load delivered to the patient to prevent overinfusion of saline to the patient.
• The tubing set must not be primed or purged while in-line with a catheter that is inside the patient because the air bubble detector is disabled during priming or purging.
• The tubing set should not be removed from the irrigation pump while in-line with a catheter that is inside the patient.
• Do not expose the tubing set to organic solvents.
• The contents are supplied sterile, using ethylene oxide (EtO). Do not use if the sterile barrier is damaged, as use of nonsterile devices may result in patient injury.
• Use the device before the “Use By” date on the device package.
• The tubing set is for single-use only. Do not reuse or re-sterilize. Adverse patient reactions, such as patient infection, may result from reuse of this device. Reuse may lead to device malfunction resulting in failure to complete the procedure or possibly patient injury.
• Store the tubing set in a cool, dry place.
• Before use, inspect the tubing set and packaging to verify that no damage has occurred. Do not use if damaged.
• To ensure proper performance, do not use the irrigation tubing set for more than 4 hours.
• Carefully load the irrigation tubing set into the irrigation pump head. Do not attempt to remove the ESD pink sleeve that is positioned over the tubing set.
• The tubing set uses an ESD pink sleeve to reduce triboelectric-charge artifacts. The ESD pink sleeve is located on the outer surface, between the retention clips. This section of the tubing must be seated smoothly under the pump head rollers, with no bends, twists, or kinks. Place the tubing snugly and smoothly over the two small metallic guides located to the right and over the one small metallic guide the left of the pump head rollers. Press the retention clips firmly into their respective slots. Confirm that the red warning lights, visible through the clips, turn off after proper positioning.
• The tubing set and irrigation pump should not be connected to any other infusion systems.

7 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.

8 Directions for use

1. Carefully remove the sterile tubing set from its packaging using standard hospital sterile technique practices and inspect for damage, rough surfaces, sharp edges, or protrusions before use. Discard if any defects are noted and contact a Medtronic representative.
2. Securely connect the 3-way stopcock to the catheter end of the tubing set and ensure that it is in the closed position before use.
3. Connect the tubing set to the IV solution container using standard hospital practices. Hang the IV container near the pump and fill the drip chamber to approximately 2/3 full.
4. Open the stopcock and fill the tubing set with the saline, maintaining aseptic technique for the patient end of the tubing set. Remove any trapped air by purging saline through the tubing until it flows freely and no bubbles are visible. Close the stopcock. To ensure proper operation of the air bubble detectors, the outer surface of the tubing set must be dry.
5. Refer to the DiamondTemp irrigation pump user manual for instructions on inserting the tubing set into the pump.

9 Device disposal

The tubing set does not contain any hazardous materials or residues that require special disposal of the device. Follow hospital and local regulations for proper disposal.

10 How supplied

The DiamondTemp tubing set is an accessory to the DiamondTemp irrigation pump and is supplied separately, along with the required documentation. The tubing set is provided sterile, provided that the packaging is unopened and undamaged at the time of use. If there is damage to the packaging, do not use the product and contact a Medtronic representative.

11 Storage

The tubing set should be stored in its original packaging. Take care to ensure that the device will not be damaged. Store in a cool and dry place, in a 15°C to 30°C (59°F to 86°F) noncondensing environment.

12 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 tubing set, hereafter referred to as Product:
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(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 not have been used for any other patient.
(4) 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.
*M005673C001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
© 2021 Medtronic M005673C001 A 2021-02-02
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