AAMI EC53 pdf free download

AAMI EC53 pdf free download.ECG trunk cables and patient leadwires.
3.4 FLEX RELIEF : The portion of the TRUNK CABLE or PATIENT LEADWIRE assembly at the junction of the connector to the assembly that prevents flexure of the assembly from damaging the assembly or the connector. NOTE—F LEX RELIEF may be part of the strain relief. Strain relief is the part of a connector/cable that supports the connection and prevents forces that are applied to the cable from being transferred to the contacts and wires within the connector housing. 3.5 INSTRUMENT CONNECTOR : The connector on a TRUNK CABLE that mates to an INSTRUMENT CONNECTOR RECEPTACLE on an ECG DEVICE . 3.6 INSTRUMENT CONNECTOR RECEPTACLE : The connector on an ECG DEVICE that mates to an INSTRUMENT CONNECTOR . 3.7 MULTI – PATIENT USE : Products specifically not labeled for SINGLE USE or SINGLE – PATIENT USE . 3.8 PATIENT – END TERMINATION : The connector on a PATIENT LEADWIRE that connects to an electrode on the PATIENT . 3.9 PATIENT LEADWIRE CONNECTOR : The connector on a PATIENT LEADWIRE that allows the leadwire to mate to a CABLE YOKE (or directly to the ECG DEVICE having an integrated CABLE YOKE ). 3.10 PATIENT LEADWIRE : A cable that ends with a PATIENT – END TERMINATION and a PATIENT LEADWIRE CONNECTOR . 3.11 SINGLE USE : Products specifically labeled as being for a single use on a single PATIENT . 3.12 SINGLE – PATIENT USE : Products specifically labeled as being for longer term use on a single PATIENT only. 3.13 TRUNK CABLE : The portion of the CABLE ASSEMBLY within which all wires are bundled together into one jacket or are in some way bound permanently together. Typically, this has a CABLE YOKE at one end with connectors for PATIENT LEADWIRES , and an INSTRUMENT CONNECTOR at the other end for connecting to the ECG DEVICE.5.1.2 C ABLE YOKE labeling The CABLE YOKE shall have each PATIENT LEADWIRE position permanently marked (e.g., molded or engraved) with the appropriate electrode designation and color code per ANSI/AAMI/IEC 60601-2-27 or ANSI/AAMI/IEC 60601-2-47 Labeling of connection polarity is not required, but is customary for products such as ambulatory ECG recorders. 5.1.3 P ATIENT LEADWIRE termination labeling If the entire wire is not appropriately color-coded, the terminations on both ends of the PATIENT LEADWIRE shall be color-coded per ANSI/AAMI/IEC 60601-2-27or ANSI/AAMI/IEC 60601-2-47. If the PATIENT LEADWIRE CONNECTOR is not separable from the CABLE YOKE , then only the PATIENT – END TERMINATION shall be color-coded. The PATIENT – END TERMINATION should include nomenclature that reinforces the color designation (i.e., R, L). 5.1.4 *Labeling to identify the location of current-limiting devices C ABLE ASSEMBLIES or ECG DEVICES that incorporate current-limiting devices (e.g., for defibrillation protection) shall be permanently marked to indicate that current-limiting devices are present. Also see subclause 5.2.2. When current-limiting devices are intentionally positioned as close to the patient as possible, the unit package supplied to the clinical OPERATOR that is associated with the component that contains the current-limiting devices shall be permanently marked to indicate that current-limiting devices are present.5.2.1 *P ATIENT LEADWIRE to TRUNK CABLE interconnection Connector stems (see the 4.5 mm dimension in Figures 1 and 2) may include features intended to ensure proper retention forces for PATIENT LEADWIRE CONNECTORS in the CABLE YOKE provided that interchangeability is not affected. For CABLE ASSEMBLIES in which non-shielded PATIENT LEADWIRES are separable from the TRUNK CABLE as single leadwires, the connection between PATIENT LEADWIRE CONNECTORS and the CABLE YOKE should meet the tolerances of Figure 1 and the CONDUCTIVE CONNECTION requirements of IEC 60601-1 and IEC 60601-2-49.AAMI EC53 pdf download.