BD INTRAOSSEOUS Powered Driver Instructions For Use page 2

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– 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 different 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

Temperature

instructions

Limitation

for use

Serial

IP33 – protection from solid

Number

objects and falling water

Caution: Federal law (USA) restricts this

device to sale by or on the order of a licensed

healthcare practitioner.

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.

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

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations IEC 61000-3-3

Complies

5 (continued)

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

Compliance Level

Level

Conducted RF

AC Mains

IEC 61000-4-6

80% AM at 1 kHz or

80% AM at 1 kHz

risk frequency

or risk frequency

150 kHz – 80 MHz

DC & I/O & Patient

DC & I/O &

Coupled (>3m)

Patient Coupled

(>3m)

3V with 6V ISM,

Home: 6V Amateur

3V with 6V

radio

ISM, Home: 6V

Amateur radio

80% AM at 1 kHz or

risk frequency

80% AM at 1 kHz

or risk frequency

150 kHz – 80 MHz

Radiated RF

10V/m,

(E1) = 10V/m

IEC 61000-4-3

80% AM at 1 kHz 80

MHz – 2700 MHz

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 affected 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.

7 (continued)

Humidity

Atmospheric

Limitation

Pressure

Limitation

Direct Current

Type BF

5V - 1 A

Applied Part

Manufacturer

Date of

manufacture

Electromagnetic Environment - Guidance

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.

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.

Electromagnetic Environment - Guidance

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

3,5

— —

d = [

]

√ P

V 1

3,5

— —

d = [

]

√ P

80 MHz to 800 MHz

E 1

— —

d = [

]

√ P

800 MHz to 800 MHz

E 1

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,

should be less than

the compliance level in each frequency range.

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

Electrostatic

± 8 kV for Contact Discharge

discharge

(ESD) IEC

±2 kV, ±4 kV , ±8 kV and

±2 kV, ±4 kV, ±8 kV and

61000-4-2

±15kV for Air Discharge

Electrical fast

±2kV for power supply lines

transient/burst

±1kV for input/output lines

IEC 61000-4-4

Surge IEC

AC Mains Line to Ground

61000-4-5

±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)

Voltage

<5% UT (100% dip in UT) for

dips, short

0.5 cycles

interruptions

0% UT (100% dip in UT)

and voltage

for 1 cycle

variations on

70% UT (30% dip in UT) for

power supply

25/30 cycles

input lines IEC

61000-4-11

<5% UT (100% dip in UT) for

250/300 cycles

Power

30 A/m

frequency

(50/60Hz)

magnetic field

IEC 61000-4-8

NOTE: UT is the a.c mains voltage prior to application of the test level.

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.

Separation distance according to frequency of transmitter (m)

Rated

maximum

150 kHz to 80 MHz

80 MHz to 800 MHz

output power

3,5

— —

of transmitter

d = [

]

√ P

V 1

(W)

0.01

0.12

0.1

0.38

1.2

3.8

100

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 affected 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.

This limited product warranty is in lieu of all other warranties, whether express or implied, (including, but not

limited to, any implied warranty of merchantability or fitness for a particular purpose). The liability and remedy

stated in this limited product warranty will be the sole liability of BD and remedy available to purchaser for this

product, whether in contract, tort (including negligence) or otherwise, and BD will not be liable to purchasers for

any indirect, special, incidental, or consequential damages arising out of its handling or use.

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

Electromagnetic Environment -

Guidance

Floors should be wood, concrete or

ceramic tile. If floors are covered

with synthetic material, the relative

humidity should be at least 30%.

Mains power quality should be that

of a typical commercial or hospital

environment.

Mains power quality should be that

of a typical commercial or hospital

environment.

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 magnetic fields

should be at levels characteristic

of a typical location in a typical

commercial or hospital environment.

6 (continued)

800 MHz to 2,7 GHz

3,5

— —

]

d = [

]

√ P

E 1

0.23

0.73

2.3

7.3

0754809 2022-02