B T L - 1 3 0 0
U S E R M A N U A L
M e d i c a l T e c h n o l o g i e s s . r . o .
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2 . 1 A P L I C A B L E S T A N D A R D S
No. Name
EN, ISO
1
Medical electrical equipment
Part 1: General requirements for safety
EN 60601-1
2
Amendments to EN 60601-1
A2
3
Medical electrical equipment
Part 1: General requirements for safety
2.Collateral Standard: Electromagnetic compatibility. Requirements and tests.
EN 60601-1-2
4
Medical devices – Risk Analysis
EN 1441
5
Biological evaluation of medical devices – Part 1: Evaluation and testing
EN ISO 10993-1
6
Medical electrical equipment
Part 2: Special requirements for safety electrical couches for hospital use
EN 60601-2-38
2 . 2 C L A S S I F I C A T I O N
Class according to NV 180 (93/42/EEC):
I
Type applied part
B
Class according EN 60601-1
II
2 . 3 I D E N T I F I C A T I O N O F T H E E Q U I P M E N T
1. Type of the product
BTL-1300
2. Name of the product
therapy
couch
3.
Region
of
use medical
device
2 . 4 O P E R A T I N G C O N D I T I O N S
1.
ambient
temperature
-10°C
to
+55°C
2.
relative
humidity
30%
to
75%
3.
atmospheric
pressure
700
to
1060hPa
4.
position
vertical
–
on
legs
5.
type
of
operation
continuous
2 . 5 T R A N S P O R T A N D S T O R A G E C O N D I T I O N S
1.
ambient
temperature
-10°C
to
+55°C
2.
relative
humidity
25%
to
85%
3.
atmospheric
pressure
650
to
1100hPa
4.
position
vertical
–
on
legs
5.
time
max.
1
year
2 . 6 P O W E R S U P P L Y
1.
Voltage
AC
230
V
2.
Frequency
50
Hz