DiamondTemp™ CEDTEGM100
EGM 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™
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
ISO 15223-1
c
Symbol title/Reference
number Explanatory text
Consult instructions for use
(clause 5.4.3)
21 CFR 801.109
EN 50419
a
b
Prescription only USA Federal law restricts this
Recycle: Electronic Equipment
ISO 15223-1
c
Reorder/catalog number
(clause 5.1.6)
ISO 15223-1
c
Batch code
(clause 5.1.5)
ISO 15223-1
c
Manufacturer
(clause 5.1.1)
ISO 15223-1
c
Date of manufacture
(clause 5.1.3)
N/A Manufactured in / manufac-
turing site
Consult instructions for use
at this website:
www.medtronic.com/manuals
device to sale by or on the
order of a licensed healthcare practitioner.
Do NOT throw in trash.
Indicates the manufacturer’s
reorder 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 where the device
was manufactured
ISO 15223-1
c
Keep Dry
(clause 5.3.4)
Indicates a medical device
that needs to be protected
from moisture
ISO 15223-1
c
Fragile, handle with care
(clause 5.3.1)
Indicates the device is fragile
and should be handled with
care
ISO 15223-1
c
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
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
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Symbol
Standard/Standard title or
reference
ISO 15223-1
c
Symbol title/Reference
number Explanatory text
Humidity limitation
(clause 5.3.8)
Indicates the range of humidity to which the medical
device can be safely
exposed
ISO 15223-1
ISO 15223-1
c
c
Medical device
(clause 5.7.7)
Model number
(clause 5.1.10)
Indicates the device is a
medical device
Indicates the model number
of the device
N/A Package contents Indicates the components
included in the device package
ISO 7000
d
Product documentation
(symbol 0419)
Indicates that product documentation is included in the
device package
N/A EGM cable Indicates that a cable is inclu-
ded in the device package
EU medical device directive/regulation
CE mark of conformity Signifies European technical
conformity to applicable
European Union acts
ISO 15223-1
c
Authorized representative in
European Community
(clause 5.1.2)
Indicates the authorized representative in the European
Community
N/A For US audience only Indicates that the information
is only intended for the U.S.A.
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
ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be
supplied
d
ISO 7000: Graphical symbols for use on equipment
2 Device description
The Medtronic DiamondTemp EGM cable (CEDTEGM100) connects the RF generator to a hospital’s compatible
EP recording system. This feature is used with the DiamondTemp ablation catheters. (Note: Any electronic
recording or stimulation equipment used with the catheter must be compliant with the applicable standards, such
as IEC 60601-1.)
The DiamondTemp EGM cable is supplied separately for use with the DiamondTemp RF generator. The EGM
cable should be used only with the DiamondTemp ablation system.
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Figure 1. DiamondTemp EGM cable
1 Male, 9-pin connector
2 Male, 2.0 mm shrouded pin connectors (x4)
3 D1 pin connector
4 D2 pin connector
5 R1 pin connector
6 R2 pin connector
3 Contents of package
The cable is supplied nonsterile. The package contains the following items:
• One model CEDTEGM100 EGM cable
• Product documentation
4 Indications for use and contraindications
Refer to the instructions for use for the compatible DiamondTemp catheter being used for the indications for use
and contraindications.
5 Intended use
The DiamondTemp EGM cable is intended to connect the DiamondTemp RF generator to an external EP recording
system.
6 Warnings and precautions
Review the system documentation – The EGM cable is part of the DiamondTemp ablation system. Review the
DiamondTemp catheter instructions for use and other DiamondTemp system instructions for use for warnings and
precautions, adverse events, and instructions.
Product compatibility – For use only with the DiamondTemp RF generator. Use with other ablation systems has
not been assessed, and may compromise patient or operator safety.
Inspect the package – Carefully inspect the package before opening. If the package has been damaged or
opened, do not use and contact a Medtronic representative.
Inspect the cable – Inspect the cable thoroughly. Check for insulation damage, such as brittleness, cracking, or
bare spots. Do not use the cable if it appears to be damaged.
Connection to generator – 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.
Cable integrity – Do not use the cable if it is kinked or damaged. If the cable becomes kinked or damaged while
in use, remove it and use a new cable.
5
Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 60601-1 Type CF
equipment or equivalent) or patient injury or death may occur. Leakage current from any connected device to the
patient must not exceed 10 micro Amps (µA) under any circumstances.
Do not modify – Do not modify this equipment. Modifications may reduce system effectiveness and impact
patient health.
Cleaning – Do not immerse in any liquid. Do not use an automated cleaning or disinfection process with this
component.
Disposal – Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product
according to local regulations.
Sterilization and reuse – The cable is provided nonsterile and is not intended for sterilization. The cable can be
reused up to ten (10) times. Reusing the cable more than ten times may lead to device malfunction, resulting in
failure to complete the procedure or possibly patient injury.
Serious incident – If a serious incident related to the device occurs, immediately report the incident to Medtronic
and the applicable competent authority or regulatory body.
Technical manual information – If you find information in this manual that is incorrect or illegible, contact your
Medtronic representative or your local competent medical authority.
7 Adverse events
For potential adverse events, see the instructions for use for the compatible DiamondTemp catheter being used.
8 Directions for use
Note: Inspect the cable before use. Do not use this cable if it appears to be damaged.
To connect the EGM cable, use the following steps:
1. Insert the connector on the cable into the EGM output (ECG/Pace) on the DiamondTemp RF generator.
2. Connect the four 2 mm shrouded pins on the end of the cable to the EP recording system (D1, D2, R1, R2 as
shown in Figure 1). The D1 pin corresponds to the most distal tip electrode.
To disconnect the cable, pull back on the locking ring to release the cable and then detach the cable from the
generator.
For additional information on using the cable with the RF generator, see the DiamondTemp RF Generator User
Manual.
9 Cleaning and disposal
After use, the cable may be reused (up to 10 times) or disposed per standard procedures for electrical cables and
in accordance with local laws and regulations.
The cable is not required to be cleaned before use, but it may be cleaned between uses. To clean the cable, use
the following steps:
1. Clean the cable by wiping it with a damp cloth. If necessary, use a mild detergent solution.
Caution: Do not immerse the cable. Do not allow any fluid or moisture into any connector. The cable and
attached devices may not function correctly if the connectors get wet.
Caution: Do not clean the cable with aggressive solvents or the cable may be damaged.
6
2. Dry thoroughly.
Caution: Inspect this component thoroughly after cleaning and before reuse. Check for insulation damage,
such as brittleness, cracking, or bare spots. Do not use this component if it appears to be damaged.
10 Specifications
Length 3.0 m (9.8 ft)
Environmental conditions
Operational 15°C to 30°C (59°F to 86°F), 30% to 75% relative humidity (non-
condensing)
Storage 15°C to 30°C (59°F to 86°F)
Transit -30°C to 60°C (-22°F to 140°F), 15% to 90% relative humidity (non-
condensing)
Safety information Compliance to IEC 60601-1, IEC 60602-2-2
11 Limited warranty
The following limited warranty applies to customers within the United States only:
A. This limited warranty provides the following assurance to the customer of the Medtronic DiamondTemp RF
generator, irrigation pump, GenConnect cable, and EGM cable, with reusable parts (foot switch, ethernet cable,
and power cord), hereafter collectively referred to as the DiamondTemp ablation system. Subject to the limitations
herein, Medtronic warrants the DiamondTemp ablation system sold to the customer will be free from defects in
materials and workmanship under normal usage for a period of 12 months from the delivery date at the customer’s
facility.
B. Should the DiamondTemp ablation system fail to meet the above warranty, Medtronic will at its option, repair or
replace such DiamondTemp ablation system, or any portion thereof. For the limited warranty to apply, the following
conditions must be met:
(1) Medtronic must be notified of and confirm the failure of the alleged defect within 60 days after discovery of the
defect.
(2) The DiamondTemp ablation system must not have been repaired or altered outside of authorized personnel at
Medtronic.
(3) THE DIAMONDTEMP ABLATION SYSTEM MUST BE USED IN ACCORDANCE WITH LABELING AND NOT
ALTERED OR SUBJECTED TO MISUSE, ABUSE, IMPROPER HANDLING, OR ACCIDENT, INCLUDING, BUT
NOT LIMITED TO, FIRE, FLOOD OR NATURAL DISASTERS.
C. At the discretion of Medtronic, parts or assemblies used or installed as part of the DiamondTemp ablation
system may be either new or rebuilt of equal or improved quality. All parts removed or replaced during maintenance
become the property of Medtronic.
D. This limited warranty is limited to its express terms. In particular:
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(1) Except as expressly provided by this limited warranty, MEDTRONIC EXPRESSLY DISCLAIMS ANY
REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WHETHER AS TO
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE REMEDIES
SET FORTH IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE TO THE CUSTOMER OR
ANY THIRD PARTY FOR BREACH OF WARRANTY. MEDTRONIC SHALL HAVE NO LIABILITY TO ANY
PERSON FOR INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY DESCRIPTION,
WHETHER ARISING OUT OF WARRANTY, OTHER CONTRACT, TORT, OR OTHERWISE.
(2) Except as expressly provided by this limited warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY
DIRECT, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT,
MALFUNCTION, OR FAILURE OF THE DEVICE TO FUNCTION WITHIN NORMAL TOLERANCE, WHETHER
THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.
E. 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 customer specific legal rights. The customer may also have other rights that vary from state to state.
F. No person has any authority to bind Medtronic to any representation, condition, or warranty except this limited
warranty.
G. This limited warranty is not applicable to accessories or products used with the DiamondTemp ablation system
unless specifically noted.
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Medtronic, Inc.
*M008961C001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
© 2021 Medtronic
M008961C001 A
2021-02-02
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