BD INTRAOSSEOUS Powered Driver User manual
5 (continued)
7 (continued)
6 (continued)
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Non-life supporting ME Equipment
The BD™ Intraosseous Powered Driver is intended for use in the electromagnetic environment specified below. The customer
or the user of the BD™ Intraosseous Powered Driver should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance Level Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
AC Mains
3V
80% AM at 1 kHz or
risk frequency
150 kHz – 80 MHz
DC & I/O & Patient
Coupled (>3m)
3V with 6V ISM,
Home: 6V Amateur
radio
80% AM at 1 kHz or
risk frequency
150 kHz – 80 MHz
AC Mains
3V
80% AM at 1 kHz
or risk frequency
150 kHz – 80 MHz
DC & I/O &
Patient Coupled
(>3m)
3V with 6V
ISM, Home: 6V
Amateur radio
80% AM at 1 kHz
or risk frequency
150 kHz – 80 MHz
Portable and mobile RF communications equipment
should be used no closer to any part of the BD™
Intraosseous Powered Driver, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 800 MHz
d = [ ]
3,5
V1
—
—
√P
d = [ ]
3,5
E1
—
—
√P
d = [ ]
7
E1
—
—
√P
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,ashould be less than
the compliance level in each frequency range.b
Radiated RF
IEC 61000-4-3
10V/m,
80% AM at 1 kHz 80
MHz – 2700 MHz
(E1) = 10V/m
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the “Product Name” is used exceeds the applicable RF compliance
level above, the “Product Name” should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the BD™ Intraosseous Powered Driver.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Recommended separation distances between portable and mobile RF communications equipment and the
BD™ Intraosseous Powered Driver Non-life supporting ME Equipment
The BD™ Intraosseous Powered Driver is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the BD™ Intraosseous Powered Driver can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the BD™ Intraosseous Powered Driver as recommended below, according to the maximum
output power of the communications equipment.
Rated
maximum
output power
of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = [ ]
3,5
V1
—
—
√P
80 MHz to 800 MHz
d = [ ]
3,5
E1
—
—
√P
800 MHz to 2,7 GHz
d = [ ]
7
E1
—
—
√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reflection from structures, objects and people.
Warranty
BD warrants to the original purchaser that this product will be free from defects in material and workmanship for a period of two (2)
years from the date of purchase. IF this product proves to be so defective, purchaser may return same to BD for repair, replacement,
refund, or credit at BD’s option. All returns must be authorized in advance in accordance with BD’s Returned Goods Policy found in
its then current Price List. The warranty on the repaired or replaced unit continues from the purchase date of the original unit. The
liability of BD under this limited warrantly does not extend to any abuse, misuse, modification, improper storage, alteration, further
manufacture, packaging or processing of the product or repair by anyone other than a BD representative.
The following will also void this limited warranty:
• Opening or servicing any component of the BD™ Intraosseous Power Driver by anyone other than BD authorized service personnel.
• Removing system labels by anyone other than service personnel authorized by BD.
• Connecting the BD™ Intraosseous Power Driver to any AC adapter other than the system adapter.
T , , (,
, ). T
BD
, , ( ) , BD
, , , .
Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be
entitled to additional remedies under the laws of your state/country.
Manufacturer: Bard Access Systems, Inc., 605 North 5600 West, Salt Lake City, UT 84116 U.S. 801.522.5000
BD and the BD Logo are trademarks of Becton, Dickinson and Company or its aliates. ©2022 BD. All rights reserved.
0754809 2022-02
– Eliminate or reduce EMI with technical solutions (such as shielding).
– Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to EMI.
– Share relevant EMI information with others, particularly when evaluating new equipment purchases which may
generate EMI.
– Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
• This Equipment is designed to comply with IEC 60601-1-2. This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with instructions, may cause harmful interference to other devices in the
vicinity; however, there is no guarantee that interference will not occur in a particular installation. Harmful interference to
other devices can be determined by turning this equipment ON and OFF. Try to correct the interference using one or more
of the following:
– Reorient or relocate the receiving device.
– Increase the separation between the equipment.
– Connect the equipment to an outlet on a dierent circuit from that to which the other device(s) are connected and
consult the BD service technician for help.
– Consult BD for help.
Symbol Glossary
Consult
instructions
for use
Temperature
Limitation
Humidity
Limitation
Atmospheric
Pressure
Limitation
Serial
Number
IP33 – protection from solid
objects and falling water
Direct Current
5V - 1 A
Type BF
Applied Part
Caution: Federal law (USA) restricts this
device to sale by or on the order of a licensed
healthcare practitioner.
Manufacturer
Waste of electrical and electronic equipment must not be disposed as unsorted
municipal waste. It must be collected separately, and must be disposed as
per local regulations. Contact BD authorized representative for information
concerning the decommissioning of your equipment.
Date of
manufacture
Electromagnetic Compatibility (EMC) Tables For RF Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The BD™ Intraosseous Powered Driver is intended for use in the electromagnetic environment specified below.
The user of the BD™ Intraosseous Powered Driver should assure that it is used in such an environment.
Emissions Tests Compliance Electromagnetic Environment - Guidance
RF emissions CISPR 11 Group 1 The BD™ Intraosseous Powered Driver uses RF energy only for
its internal function; therefore, its RF emissions are very low
and are not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B The BD™ Intraosseous Powered Driver is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations IEC 61000-3-3 Complies
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The BD™ Intraosseous Powered Driver is intended for use in the electromagnetic environment specified below. The customer
or the user of the BD™ Intraosseous Powered Driver should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -
Guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
± 8 kV for Contact Discharge
±2 kV, ±4 kV , ±8 kV and
±15kV for Air Discharge
± 8 kV for Contact Discharge
±2 kV, ±4 kV, ±8 kV and
±15kV for Air Discharge
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1kV for input/output lines
±2kV for power supply lines
±1kV for input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC
61000-4-5
AC Mains Line to Ground
±0.5kV, ±1kV and ±2kV
AC Mains Line to Line ±0.5kV
and ±1kV
DC Input (>3m) Line to Line
±0.5kV and ±1kV
DC Input (>3m) Line to
Ground ±0.5kV, ±1kV and
±2kV
I/O, Line to Ground ±2kV
(Outdoor Line only)
AC Mains Line to Ground
±0.5kV, ±1kV and ±2kV
AC Mains Line to Line ±0.5kV
and ±1kV
DC Input (>3m) Line to Line
±0.5kV and ±1kV
DC Input (>3m) Line to
Ground ±0.5kV, ±1kV and
±2kV
I/O, Line to Ground ±2kV
(Outdoor Line only)
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT (100% dip in UT) for
0.5 cycles
0% UT (100% dip in UT)
for 1 cycle
70% UT (30% dip in UT) for
25/30 cycles
<5% UT (100% dip in UT) for
250/300 cycles
<5% UT (100% dip in UT) for
0.5 cycles
0% UT (100% dip in UT)
for 1 cycle
70% UT (30% dip in UT) for
25/30 cycles
<5% UT (100% dip in UT) for
250/300 cycles
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the BD™ Intraosseous Powered
Driver requires continued operation
during power mains interruptions,
it is recommended that the BD™
Intraosseous Powered Driver be
powered from an uninterrupted power
supply or a battery.
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE: UT is the a.c mains voltage prior to application of the test level.
