User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
54
The “Body Guardian” Control Unit is intended from adult without race exclusion.
Patient with implanted device are excluded to wear this
device.
Applied Standards
Standard
Edition /
year
Description
IEC 60601-1
Ed. 2 + A1 + A2
+ Deviation
UL/CSA
Medical Electrical Equipment – General requirement for safety
IEC 60601-1-1
Ed. 2
Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2
Ed. 2 + A1
Collateral standard: Electromagnetic compatibility
Requirements and tests
IEC 60601-1-4
Ed. 1
Collateral standard: Programmable electrical medical systems
IEC 60601-1-6
Ed. 1
Collateral standard: Usability
IEC 60601-2-47
Ed. 1
Particular requirements for the safety, including essential performance,
of ambulatory electrocardiographic systems
IEC 60601-2-49
Ed 1 + Ec1
Particular requirements for the safety of multifunction patient
monitoring equipment
IEC 60529
Ed. 2 + A1
Degrees of protection provided by enclosures (IP Code)
EC38
2007
Particular requirements for the safety, including essential
performance, of ambulatory electrocardiographic systems
EC57
Ed. 2
Testing and reporting performance results of cardiac rhythm
and ST-segment measurement algorithms
UL 60601-1
Ed. 1
Safety of Medical Electrical Equipment Part 1 – General requirements
for Safety
CAN/CSA C22.2
Ed. 2 + A1 + A2
Medical Electrical Equipment Part 1 – General requirements for Safety
Type of protection against electric shocks
Internal powered equipment.
Protection level against electrical direct and indirect contacts
BF type (patient inputs)
Protection level against inflow of solids and liquids
IPX4 Device protected against
Operational mode
Continuous, within the specified limits
Environmental conditions for usage
- Temperature: from +10°C to +45°C
- Relative humidity: from 10% to 95% RH
- Atmospheric pressure: from 700hPA to 1060hPA
Environmental conditions for storage (max. 15 weeks )