Medtronic CEDTEGM100 Instructions for Use

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

3