Guidance And Manufacturer's Declarations - BD PureWick PW200E Guía Del Usuario Y Garantía

Guidance and Manufacturer's Declarations

Table 1: Electomagnetic emissions
This equipment is intended for use in the electromagnetic
environment specified below. The user of the equipment should
assure that it is used in such an environment
Emissions Test
Radiated emissions
EN 55011
Conducted emissions
CISPR 11 / EN 55011
AC Power-line harmonics
IEC 61000-3-2
AC Power-line Flicker
IEC 61000-3-3
Table 2: Electomagnetic immunity
This equipment is intended for use in the electromagnetic
environment specified below. The user of the equipment should
assure that it is used in such an environment.
Immunity Test IEC 60601 test level
Electrostatic + 8 kV Contact,
discharge HCP & VCP
IEC 61000-4-2 +2 kV, +4 kV, +8 kV,
+ 15 kV Air
Radiated RF 80 MHz - 2.7 GHz,
Immunity 10 V/m, 80% 1 kHz AM
IEC 61000-4-3
Electrical Fast + 2 kV
Transient/Burst (100 kHz rep rate)
IEC 61000-4-4 AC mains
+ 1 kV
(100 kHz rep rate)
I/O > 3m
Surge Immunity +0.5 kV & + 1 kV
IEC 61000-4-5 line-line, AC mains
+0.5 kV, + 1 kV, + 2 kV
lineground, AC mains
Conducted RF 150 kHz to 80 MHz,
immunity 3 Vrms, 80% 1 kHz AM,
IEC 61000-4-6 power and I/O
6 Vrms (+modulation)
for ISM frequencies
Power Frequency 50 and 60 Hz, 30 A/m,
x-, y-, and z- axes
H-field
IEC 61000-4-8
Voltage Dips, 100% reduction for
Interrupts 0.5 cycles
IEC 61000-4-11 100% reduction for
1.0 cycle
30% reduction for
25/30 cycles
100% reduction for
250/300 cycles
Compliance
Complies (Group B, Group 1)
Complies
Complies
Complies
Compliance level
+ 8 kV Contact,
HCP & VCP
+2 kV, +4 kV, +8 kV,
+ 15 kV Air
80 MHz - 2.7 GHz,
10 V/m, 80% 1 kHz AM
+ 2 kV
(100 kHz rep rate)
AC mains
+ 1 kV
(100 kHz rep rate)
I/O > 3m
+0.5 kV & + 1 kV
line-line, AC mains
+0.5 kV, + 1 kV, + 2 kV
lineground, AC mains
150 kHz to 80 MHz,
3 Vrms, 80% 1 kHz AM,
power and I/O
6 Vrms (+modulation)
for ISM frequencies
50 and 60 Hz, 30 A/m,
x-, y-, and z- axes
100% reduction for
0.5 cycles
100% reduction for
1.0 cycle
30% reduction for
25/30 cycles
100% reduction for
250/300 cycles
The PureWick™ Urine Collection System bears the
following symbols:
Units
Catalog
Number
Lot
Number
Serial
Number
Use By
date
Humidity
Limitation
Medical
MD
Device
Authorized Representative
in the European
Community
IP21 Classification – Protection of equipment against ingress of
solid foreign objects which are greater than or equal to 12.5mm in
diameter and protection of equipment against harmful effects of
ingress from vertically dripping water.
BD, the BD Logo, and PureWick are trademarks of Becton, Dickinson
and Company. © 2021 BD and its subsidiaries. All rights reserved.
10
Non-sterile Class II
Do not use
Type BF
if package
Applied Part
is damaged
Consult
Instructions
Caution
For Use
eifu.bd.com
Temperature
Manufacturer
Limit
Caution, Risk
Date of
of Electric
Manufacture
Shock
Do not
Atmospheric
dispose of
Pressure
in garbage
Limitation
Degree of
Single patient -
Protection
multiple reuse
against harmful ingress
of water and particulate
matter.
Certified To CSA STD C22.2 NO. 60601-1
Conforms To Medical Electrical Equipment
STDS 60601-1, 60601-1-6 and 60601-1-11
BD Switzerland Sàrl
Terre Bonne Park – A4
Route de Crassier 17
1262 Eysins, Switzerland
Manufacturer:
C. R. Bard, Inc.
Covington, GA 30014 USA
1-800-526-4455
www.purewick.com