CVRx BAROSTIMIPG1 Manual De Usuario
SPECIFICATIONS OF NONIMPLANTABLE COMPONENTS
BAROSTIM NEO LEGACY REFERENCE GUIDE
16-1
1
1
6
6
S
S
P
P
E
E
C
C
I
I
F
F
I
I
C
C
A
A
T
T
I
I
O
O
N
N
S
S
O
O
F
F
N
N
O
O
N
N
I
I
M
M
P
P
L
L
A
A
N
N
T
T
A
A
B
B
L
L
E
E
C
C
O
O
M
M
P
P
O
O
N
N
E
E
N
N
T
T
S
S
Programmer System
Specification
Value
Operating temperature
50° F to 95° F (10° C to 35° C)
If equipment has been stored at temperature extremes, then the equipment
should be placed at operating temperature for at least 1 hour prior to use.
should be placed at operating temperature for at least 1 hour prior to use.
Atmospheric pressure
525 mmHg to 760 mmHg (700 hPa to 1010 hPa)(10.2 psia to 14.7psia)
Vibration
0.5G, 10 to 500 Hz, 0.5 octave/min sweep rate
Storage/shipping
temperature
temperature
-4
o
F to 140
o
F (-20
o
C to 60
o
C)
Storage/shipping humidity
5% to 90% relative humidity
Programmer System Components
Component
Specification
Value
Programmer Interface
Power Supply Input
From computer
Programmer System
IEC60601-1-2 System
Clause
Clause
Additional equipment connected to medical electrical equipment must comply
with the respective IEC or ISO standards (e.g., IEC 60950 for data
processing equipment). Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16
of the 3rdEd. Of IEC 60601-1, respectively). 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.
with the respective IEC or ISO standards (e.g., IEC 60950 for data
processing equipment). Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16
of the 3rdEd. Of IEC 60601-1, respectively). 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
IEC60601-1-1 System
Clause
Clause
The Programmer Interface is suitable for use in the patient environment.
Computer
Specification
Value
Safety and EMC
Requirements
Requirements
•
EN 60950-1
•
UL 60950-1
•
EN 55022
•
EN 55024
•
FCC Part 15 Class B emissions