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Declaration-Electromagnetic Emissions
The EZ-IO® Power Driver is intended for use in the electromagnetic environment
specified below. The customer or the user of the EZ-IO® Power Driver should assure
that it is issued in such an environment.
Emission Test
Compliance
Compliance
The EZ-IO® Power Driver uses RF energy only for
its internal function. Therefore, its RF emissions
RF Emissions CISPR 11
Group 1
are very low and are not likely to cause
interference in nearby electronic equipment.
RF Emissions CISPR 11
Class B
The EZ-IO® Power Driver is suitable for use
in all establishments, including domestic
Harmonic emissions IEC
Not
establishments and those directly connected
applicable
61000-3-2
to the public low voltage power supply
network that supplies buildings used for
Voltage fluctuations/flicker
Not
applicable
domestic purposes.
emissions IEC 61000-3-3
Declarations – Electromagnetic Immunity
The EZ-IO® Power Driver is intended for use in the electromagnetic environment specified
below. The customer or the user of the EZ-IO® Power Driver should assure that it is issued
in such an environment.
Immunity test
IEC 60601 test level
Compliance Level Electromagnetic Environment-Guidance
Electrostatic
Floors should be wood, concrete or
discharge
+/- 6 kV Contact
+/- 6 kV Contact
ceramic tile. If floors are covered
(ESD)
+/- 8 kV air
+/- 8 kV air
with synthetic material the relative
IEC 61000-4-2
humidity should be at least 30%.
Not applicable
+/- 2 kV for power
Electrical fast
(battery
Mains power quality should be that
supply lines
Transient/burst
powered)
of a typical commercial or hospital
+/- 1 kV for input.
IEC 61000-4-4
Not applicable
environment.
output lines
(no I/O lines)
+/- 1 kV differential
Not applicable
Mains power quality should be that
Surge
mode
(battery
of a typical commercial or hospital
IEC 61000-4-5
+/- 2 kV common mode
powered)
environment.
Mains power quality should be that
< 5% Ur (>95% dip in
Voltage
of a typical commercial or hospital
Ur) for 0.5 cycles
dips, short
environment. If the user of the EZ-IO®
40% Ur (60% dip in
interruptions and
Not applicable
Power Driver requires continued
Ur) for 5 cycles
voltage variations
(battery
operation during power mains
70% Ur (30% dip in
on power supply
powered)
interruptions, it is recommended that
Ur) for 25 cycles
input lines IEC
the power driver be powered from
<5% Ur (95% dip in
61000-4-11
an uninterruptible power supply or
Ur) for 5 sec
a battery.
Power frequency
Power frequency magnetic fields
(50/60Hz)
should be at levels characteristic
3 A/m
3 A/m
magnetic field
of typical location in typical
IEC 61000-4-8
commercial or hospital enviroment.
NOTE: Ur is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration — Electromagnetic Immunity
The EZ-IO® Power Driver is intended for use in the electromagnetic environment
specified below. The customer or the user of the EZ-IO® Power Driver should assure
that it is used in such an environment.
IEC 60601
Compliance
Electromagnetic
Immunity test
test level
Level
environment — guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the driver including
cables, than the recommended
separation distance calculated
from the equation applicable
to the frequency of the
transmitter. Recommended
separation distance
d = 3,5
P
V
1
d = 3,5
P
E
1
Conducted RF
3 Vrms
d = 7
P
Not applicable
IEC 61000-4-6
150 kHz to 80 MHz
E
(battery powered)
1
Radiated RF
3 V/m
3 V/m
where P is the maximum output
IEC 61000-4-3
80 MHz to 2,5 GHz
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, a should be less than
the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
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 EZ-IO® Power Driver is used exceeds the applicable RF
compliance level above, the EZ-IO® Power Driver should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the EZ-IO® Power Driver. b Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3 V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EZ-IO® Power Driver
The EZ-IO® Power Driver is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the EZ-IO®
Power Driver can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the EZ-IO® Power Driver recommended below, according to the maximum output
power of the communications equipment.
Separation distance according to frequency of transmitter m
Rated maximum
output power of
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
transmitter
d = 3,5
P
d = 3,5
P
d = 7
W
V
E
E
1
1
1
.01
0.12
0.12
0.23
.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
affected by absorption and reflection from structures, objects, and people.
• Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service accordingly to the EMC information provided in this manual.
• Portable and mobile RF communications can affect medical electrical equipment.
• The use of accessories, transducers, and cables other than those specified by the
manufacturer, may result in increased emissions or decreased immunity of the EZ-IO®
Power Driver.
• The EZ-IO® Power Driver should be observed to verify normal operation in the
configuration it will be used.
• The EZ-IO® Power Driver is designed and tested to run intermittently with a duty cycle of
30 seconds on, 1 minute off for 5 consecutive cycles. Allow 1 hour cool down time.
Equipment Classification
Type of protection against electric shock
NA internal powered equipment
Degree of protection against electric shock
Type BF applied part
Degree of protection against ingress of water
IPXO Ordinary protection
Equipment not suitable for use in the presence
Degree of safety or application in the presence of
of a flammable anesthetic mixture with air or
a flammable anesthetic mixture
with oxygen or nitrous oxide
Warranty InformatIon
TELEFLEX LIMITED EXPRESS WARRANTY AND DISCLAIMERS
Teleflex warrants to the original end user of the Products only ("End User") that during the applicable Warranty
Period: (a) the hardware Products will conform with Teleflex's written product specifications for such Products
in all material respects for the shorter of (i) one year after shipment to End User or (ii) the number of uses of
such hardware Product as are specified by Teleflex in its written product specifications, and (b) the disposable
P
Products will conform with Teleflex's written product specifications for such Products in all material respects
until the expiration date designated therefor on such disposable Products (collectively, the "Warranty
Period"), unless the Products have been subjected to physical abuse, misuse, abnormal use, use not consistent
with Teleflex's published directions and instructions for use, fraud, tampering, unusual physical stress,
negligence or accidents ("Express Warranty"). Teleflex does not guarantee that the operation of a hardware
Product will be uninterrupted or error-free. Teleflex will, in its discretion, repair, replace or refund the purchase
price to End User for Product determined by Teleflex to be non-conforming ("Remedies"), provided that End
User returns the nonconforming Product to Teleflex during the applicable Warranty Period, at End User's
expense and first gives prompt written notice to Teleflex so that Teleflex can issue a Return Material
Authorization ("RMA") number. Products sent to Teleflex for warranty replacement without a valid RMA number
displayed on the outside of the shipping container may, in Teleflex's discretion, be returned to End User at End
User's expense. All returned nonconforming Product become the property of Teleflex. To the extent permitted
by law, Teleflex may repair or replace nonconforming hardware Products (a) with new or previously used
Products or parts equivalent to new in performance and reliability, or (b) with equivalent Products to an
original Product that has been discontinued. Replacement Products (or parts thereof) are warranted for the
remainder of the Warranty Period of the Product they are replacing. THE REMEDIES DESCRIBED HEREIN SHALL
BE END USER'S SOLE AND EXCLUSIVE REMEDY FOR A FAILURE OF A PRODUCT TO CONFORM TO THE EXPRESS
WARRANTY. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE EXPRESS WARRANTY IS THE SOLE
AND EXCLUSIVE WARRANTY AND GIVEN IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR
STATUTORY, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-
INFRINGEMENT, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY OR SUITABILITY. IF THE
DISCLAIMER OF ANY IMPLIED WARRANTY IS NOT PERMITTED BY APPLICABLE LAW, SUCH EXPRESS WARRANTY
IS LIMITED TO NINETY (90) DAYS FROM THE DATE OF ORIGINAL PURCHASE. OTHER THAN THE EXPRESS
WARRANTY, THE PRODUCTS ARE PROVIDED "AS IS" AND ARE DESIGNED FOR USE SOLELY BY QUALIFIED
HEALTHCARE PERSONNEL USING REASONABLE MEDICAL DISCRETION IN MEDICALLY NECESSARY SITUATIONS.
TELEFLEX DISCLAIMS ALL LIABILITY WITH RESPECT TO THE PRODUCTS ARISING FROM ANY USE OF THE
PRODUCTS THAT IS INCONSISTENT WITH TELEFLEX'S PUBLISHED DIRECTIONS AND INSTRUCTIONS FOR USE. IN
NO EVENT SHALL TELEFLEX BE LIABLE TO END USER, ANY CUSTOMER OR ANY OTHER THIRD PARTY ("CLAIMANT")
IN ANY MANNER FOR ANY SPECIAL, NON-COMPENSATORY, CONSEQUENTIAL, INDIRECT, INCIDENTAL, STATUTORY
OR PUNITIVE DAMAGES OF ANY KIND, WHETHER ARISING UNDER CONTRACT OR TORT LAW (INCLUDING
NEGLIGENCE AND STRICT PRODUCT LIABILITY),REGARDLESS OF THE FORM OF LEGAL ACTION EVEN IF TELEFLEX
IS AWARE OF THE POSSIBILITY OF ANY SUCH DAMAGES IN ADVANCE. TELEFLEX'S TOTAL AGGREGATE LIABILITY
IN CONNECTION WITH THE PURCHASE OR USE OF THE PRODUCTS SHALL NOT EXCEED THE SUM OF THE AMOUNTS
PAID BY CLAIMANT TO TELEFLEX DURING THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE DATE OF THE
EVENT GIVING RISE TO A CLAIM AGAINST TELEFLEX.
EZ-IO
INTRAOSSEOUS VASCULAR ACCESS
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