Use Instructions

49
Programmer System Components
Component
Specification
Value
Programmer Interface
Power Supply Input
From computer/tablet
Programmer System
IEC60601-1-2 System Clause
Additional equipment connected to medical
electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 62368-1
for information technology equipment).
Furthermore, all configurations shall comply with
the requirements for medical electrical systems
(see clause 16 of the 3
rd
Ed. Of IEC 60601-1).
Anybody connecting additional equipment to
medical electrical equipment configures a medical
system and is therefore responsible that the system
complies with the requirements for medical
electrical systems. Attention is drawn to the fact
that local laws take priority over the above-
mentioned requirements. If in doubt, consult your
local representative or the technical service
department.
Programmer Interface
IEC60601-1 System Clause
The Programmer Interface is suitable for use in the
patient environment.
System Installation and Maintenance
There are no Installation, Commissioning or
Modifications required for the proper use of the
Programmer System. No installation measurements
are required. Regular maintenance is also not
required.
Inspect the Programmer Interface, computer/tablet
and cables prior to each use. Notify CVRx
®
or your
CVRx representative of any items that need
replacement.
Computer/Tablet
Specification
Value
Safety and EMC Requirements
EN 60950-1
EN IEC 62368-1
UL 60950-1
EN 55022
EN 55024
FCC Part 15 Class B emissions