En Instructions For Use; Indications For Use - Philips 3 ECG Instrucciones De Uso

English

EN Instructions for Use

ASSOCIATED DOCUMENT
Refer to the Cables and Lead Sets Care, Cleaning, and Disinfection document that accompanies this
Instructions for Use (IFU) for validated lead set and cable cleaning/disinfecting agents and procedures.
INTENDED USE
Philips IntelliVue reusable ECG lead sets and trunk cables are limited by the indications for use of the
connected monitoring and diagnostic equipment, and are for use only by healthcare professionals. They are
designed for multiple patient use and indicated for monitoring cardiac signals for both diagnostic and
monitoring purposes in adult, pediatric, and neonatal patients. Philips operating room (OR) ECG trunk
cables are indicated for use to monitor patient ECG in an electrosurgery (ESU) environment when used in
combination with a compatible ECG patient lead set on adult, pediatric, infant, and neonatal ECG
applications.

Indications for Use

Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for
continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are
limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare
facilities. These devices are intended to interact with patient intact skin only.
Contraindications
There are no known contraindications.
PRODUCT DESCRIPTIONS
Tables on pages i and ii define physical characteristics and applications for all ECG lead set and trunk cable
products included in this IFU. Column headings within those tables are defined below.
AAMI Check mark
IEC Check mark
AAMI + IEC
Defines ECG trunk cables as being both AAMI and IEC compatible, with (x) or (x-x) identifying each trunk
cable's lead set connector pin configuration.
(x) or (x-x)
3
Indicates the total number of ECG leads in each lead set, and the type of electrode connector at the end of
ECG
each lead:
4
ECG
5
ECG
6
ECG
Identifies length(s) of lead set leads, or trunk cable.
Check mark
Check mark
Check mark
Defines the lead set or trunk cable catalogue reference number.
 indicates that the lead set is AAMI color coded.
 indicates that the lead set is IEC color coded.
= Grabber
= Snap
= Mini Clip
identifies lead sets that are appropriate for chest application.

 identifies lead sets that are appropriate for arm/leg application.
identifies lead sets and/or trunk cables that may be used in operating room environments.

1