BD PureWick PW200E - Guidance and Manufacturers Declarations

10
BD, the BD Logo, and PureWick are trademarks of Becton, Dickinson
and Company. © 2022 BD and its subsidiaries. All rights reserved.
Manufacturer:
C. R. Bard, Inc.
Covington, GA 30014 USA
1-800-526-4455
www.purewick.com
The PureWick ™ Urine Collection System bears the
following symbols:
Units
Use By
date
Do not use
if package
is damaged
Non-sterile
Manufacturer
Type BF
Applied Part
Class II
Caution
Date of
Manufacture
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 eects of
ingress from vertically dripping water.
Humidity
Limitation
Temperature
Limit
Atmospheric
Pressure
Limitation
Caution, Risk
of Electric
Shock
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 Compliance
Radiated emissions
EN 55011
Complies (Group B, Group 1)
Conducted emissions
CISPR 11 / EN 55011
Complies
AC Power-line harmonics
IEC 61000-3-2
Complies
AC Power-line Flicker
IEC 61000-3-3
Complies
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 Compliance level
Electrostatic
discharge
IEC 61000-4-2
+ 8 kV Contact,
HCP & VCP
+2 kV, +4 kV, +8 kV,
+ 15 kV Air
+ 8 kV Contact,
HCP & VCP
+2 kV, +4 kV, +8 kV,
+ 15 kV Air
Radiated RF
Immunity
IEC 61000-4-3
80 MHz - 2.7 GHz,
10 V/m, 80% 1 kHz AM
80 MHz - 2.7 GHz,
10 V/m, 80% 1 kHz AM
Electrical Fast
Transient/Burst
IEC 61000-4-4
+ 2 kV
(100 kHz rep rate)
AC mains
+ 1 kV
(100 kHz rep rate)
I/O > 3m
+ 2 kV
(100 kHz rep rate)
AC mains
+ 1 kV
(100 kHz rep rate)
I/O > 3m
Surge Immunity
IEC 61000-4-5
+0.5 kV & + 1 kV
line-line, AC mains
+0.5 kV, + 1 kV, + 2 kV
lineground, AC mains
+0.5 kV & + 1 kV
line-line, AC mains
+0.5 kV, + 1 kV, + 2 kV
lineground, AC mains
Conducted RF
immunity
IEC 61000-4-6
150 kHz to 80 MHz,
3 Vrms, 80% 1 kHz AM,
power and I/O
6 Vrms (+modulation)
for ISM frequencies
150 kHz to 80 MHz,
3 Vrms, 80% 1 kHz AM,
power and I/O
6 Vrms (+modulation)
for ISM frequencies
Power Frequency
H-field
IEC 61000-4-8
50 and 60 Hz, 30 A/m,
x-, y-, and z- axes
50 and 60 Hz, 30 A/m,
x-, y-, and z- axes
Voltage Dips,
Interrupts
IEC 61000-4-11
100% reduction for
0.5 cycles
100% reduction for
1.0 cycle
30% reduction for
25/30 cycles
100% reduction for
250/300 cycles
100% reduction for
0.5 cycles
100% reduction for
1.0 cycle
30% reduction for
25/30 cycles
100% reduction for
250/300 cycles
Becton Dickinson Ireland Ltd.
Donore Road, Drogheda
Co. Louth, A92 YW26
Ireland
Catalog
Number
Lot
Number
Authorized Representative
in the European
Community
MD
Medical
Device
Do not
dispose of
in garbage
Single patient -
multiple reuse
Serial
Number
Consult
Instructions
For Use
eifu.bd.com
Certied To CSA STD C22.2 NO. 60601-1
Conforms To Medical Electrical Equipment
STDS 60601-1, 60601-1-6 and 60601-1-11
Degree of
Protection
against harmful ingress
of water and particulate
matter.