M
EDEX
Medfusion 3500
Medex Operation Manual
Artwork GD000608 Revision 5
Page 8
Technical Definitions
Below is a table of technical definitions as required per international standards:
Term
Definition
Equipment in which protection against electrical shock relies on
double or reinforced insulation
instead of basic insulation. Accessible metal components of pump enclosure use this higher level of
insulation instead of safety grounding.
Equipment in which level of protection from electrical shock is defined by leakage current (C)
exposure and insulation by isolated or floating (F) metal of pump enclosure relative to earth
grounding. Under normal conditions, users are exposed to no more than 100 microamps – when
measured though the pump, and patients to no more than 10 microamps – when measured through IV
path.
Infusion Class 4
An infusion pump that combines the functions of continuous infusion flow, intermittent flow, and
discrete bolus delivery.
Infusion Class 5
An infusion pump that functions as a profile pump, providing a programmed sequence of delivery
rates.
IPX3
Equipment that is ingress protected from fluid spraying at vertical angle from above, and from angles
to 60
°
on either side of vertical.
V ~
Symbol for operating voltage range for alternating current (i.e. AC or mains) power source.
Symbol for infrared serial communications port on pump.
Symbol for external DC jack connection. Tip (negative sign) is for power ground and ring (positive
sign) is for positive power connection. [See warning below.]
Warning
!
External Power
must be
IEC 601-1
Certified
Any external power source connected to the DC jack must be IEC 601-1 certified for
medical equipment Type CF and meet Safety Class II. Connecting any external
power source to the pump creates a medical system. Therefore, the user is
responsible for compliance with IEC 601-1 standards. Refer all questions to the
Medex Technical Service Department.
Type
CF
Class
II
