BIOTRONIK SE & Co. KG ICSPGH Manual De Usuario
6
Safety Instructions
Accessories
•
Use only accessories that have been approved by
BIOTRONIK. BIOTRONIK-approved device
combinations can be used if the device to be
connected complies with the IEC 601 / EN 60601 / VDE
0750 standards series and this conformity is
substantiated by CE certification conducted by an
independent, Notified Body.
BIOTRONIK. BIOTRONIK-approved device
combinations can be used if the device to be
connected complies with the IEC 601 / EN 60601 / VDE
0750 standards series and this conformity is
substantiated by CE certification conducted by an
independent, Notified Body.
Caution!
Using unapproved accessories can impair the
electromagnetic compatibility, cause leakage
currents to exceed permissible levels, reduce the
dielectric strength, and cause functional disturbances
in both the hardware and software.
electromagnetic compatibility, cause leakage
currents to exceed permissible levels, reduce the
dielectric strength, and cause functional disturbances
in both the hardware and software.
Cables
Caution!
The plugs of the patient cable may not touch any
conductive or grounded components! Secure any
unused patient cable connectors. Never
simultaneously touch the patient and connector
components that conduct safety extra-low voltage.
conductive or grounded components! Secure any
unused patient cable connectors. Never
simultaneously touch the patient and connector
components that conduct safety extra-low voltage.
PK-222
Device: Redel, P series, 14-pin, 40° coded
— Defibrillation protection: 5 kV,
according to EN 60601-2-25 voltage limitation
to nominal 15 V nominal, 100 V maximum
to nominal 15 V nominal, 100 V maximum
— Maximum energy consumption:
l 10%; based
on defibrillation energy
— Contact resistance: 10 k
z
— Weight 0.2 kg
Patient: 4 color-coded banana plugs
PK-199 Oesophagus
Patient: 4-pin Redel plug for the esophageal lead and
four 4 mm- banana plugs for the surface leads
four 4 mm- banana plugs for the surface leads
Device: Redel, P series, 14-pin, 40° coded
NK-3
Device: Right-angle cold device socket
Power supply: Shockproof right-angle plug
422U/311
422U/311