Hologic LOCalizer User manual

LOCalizer Reader and
RFID Localization System
User Manual
Manufactured for:
Health Beacons, Inc.
383 Lowell Rd.
Concord, MA 01742
Phone: [phone]
ML-0004 Rev 06

INDICATIONS FOR USE
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for
surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance
(RFLS), the RFID Tag is located and surgically removed with the target tissue.
The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a
lesion intended for surgical removal.
LOCALIZER READER OVERVIEW
The LOC alizer Reader (Figure 1) is composed of:
1 Handheld
LOC alizer Reader
2 AA Alkaline batteries (IEC-LR6)
The
LOC alizer Reader includes an integrated Loop Probe (A) that is used to locate and read Tags from the skin
surface. It can also be used with the
LOC alizer Surgical Probe attachment (D) to locate and read Tags within the
surgical incision. Probe details are included in Table 1. Subsequent sections of this manual describe in detail probe
and
LOC alizer Reader use.
CONTRAINDICATIONS
The RFID Localization System is not intended for use under conditions where breast lesion localization
is contraindicated.
The RFID Localization System is not intended for use in the heart, eyes, brain or spinal cord.
The Tag should not be placed in a tissue site with clinical evidence of infection.
The Tag should not be placed in muscle tissue.
Figure 1. LOCalizer Reader with Surgical Probe connected (Instrument Cover not shown)
A Loop Probe (integrated)
B Screen and Control Panel
C Battery Cover
D Surgical Probe
E Surgical Probe Connector
2
CAUTION:
Read all warnings, cautions, and instructions provided with this equipment before using.
Read the instructions, warnings, and cautions provided with the Tag Applicator and LOCalizer Surgical
Probe before using. Specific instructions pertaining to Tag implantation and preparation and use of the
Surgical Probe are not included in this Manual.
DESCRIPTION
RFID Localization System
System Component
LOC
alizer Reader RFID Reader HB100
HB110
Needle applicator with preloaded RFID Tag
Attachment probe for use with LOC
alizer RFID ReaderLOC alizer Surgical Probe
Tag Applicator
Description Part Number
* XX indicates the length of the applicator needle in cm. Contact distributor for available sizes in your area.
The LOCalizer Instrument Drape (HB120) is provided separately for use with the LOCalizer Reader in a
sterile environment.
LOCalizer Reader
The LOC alizer Reader locates and reads (RFID) Tags which have been implanted using the Tag Applicator.
The
LOC alizer Reader displays the distance between the Tag and the Probe under use.
Tag location is also indicated by an audible sound of which the pitch and volume increases in proportion to a decrease
in the “
LOC alizer to Tag” distance.
The
LOC alizer Reader is a portable, battery-operated system and is supplied non-sterile. The Tag Applicator and
LOC alizer Surgical Probe are provided sterile.
This manual includes guidelines for the use of the Probe in the sterile eld.
The Tag Applicator, LOCalizer™ Reader, and LOCalizer Surgical Probe are components of the RFID Localization
System. The Tag is intended to be placed in breast tissue, within 6 cm of the breast surface, using the Tag
Applicator. The Tags, when used in conjunction with the LOCalizer Reader and LOCalizer Surgical Probe, can
be used as a guide for the surgeon to follow in the excision of tissue.
RFID Localization System (RFLS) components are listed below:
1
HB200-XX*
HB300-XX*

Do NOT use if the package or LOCalizer Reader is damaged.
The LOCalizer Reader is a non-sterile device. Drape with the sterile LOCalizer Instrument Cover (Product HB120)
when using in a sterile environment. Do NOT sterilize the LOCalizer Reader as sterility cannot be guaranteed.
Cleaning, reprocessing and sterilization of this LOCalizer Reader could cause the LOCalizer Reader to malfunction
due to adverse effects on components.
Use of the LOCalizer Reader adjacent to or stacked with other equipment should be avoided because it could
result in improper functioning. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specied or provided by Health Beacons could result
in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
The LOCalizer Reader may suffer erroneous signal detection or degraded distance accuracy of an RFID Tag due
to electromagnetic interference from HF Surgical Equipment, other RFID readers, or wireless charging devices.
Portable RF communications equipment such as cell phones or tablets should be used no closer than 30 cm
(12 inches) to any part of the LOCalizer Reader to avoid degradation of the performance of this equipment.
With the exception of battery replacement, no modication or repair of this equipment by the user is allowed.
If the LOCalizer Reader stops working or is damaged it should be replaced.
The user is responsible to maintain FCC compliance. Any changes, modications, or use of non-Health Beacons
probes could void the user’s authority to operate the equipment.
LOCalizer Reader
The Tag Applicator with Tag and Surgical Probe have been designed for SINGLE USE only. Reusing this medical
device bears the risk of cross-patient contamination. The residue of biologic material can promote the
contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
DO NOT RESTERILIZE. After sterilization, the sterility of the product is not guaranteed because of an
indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious
complications. Cleaning, reprocessing and/or re-sterilization of the present medical device increases the
probability that the device will malfunction due to potential adverse effects on components that are inuenced
by thermal and/or mechanical changes.
4
Probe
Loop Probe (integrated) n/a
HB110
6 cm*
3 cm**Surgical Probe
Part No.
12 mm inner diameter
39 mm outer diameter
175 mm long
8 mm diameter
Probe Dimensions Max Reading Depth
* As measured from center of the Loop probe to end of Tag (Figure 3)
** As measured from end of the Surgical probe to end of Tag (Figure 4)
WARNINGS
The LOC alizer Reader is designed only for use with the LOC alizer Surgical Probe and Tags.
General
The Tag Applicator is intended for sterile use. Do NOT use this product on a non-sterile surface prior to use internally.
Caution should be exercised with using the device on patients with prostheses so as to not puncture the
prosthesis during placement.
If any resistance is felt during advancement of the Surgical Probe or Tag Applicator (during implantation), carefully
correct the orientation but never apply strong forces in order to overcome the obstacle.
Exercise caution when placing the Tag near the chest wall. Insert the Needle applicator parallel to the chest wall
so as to not puncture the chest wall during placement.
To avoid confusion between signals produced by both Tags, it is recommended that no more than one Tag is
implanted in the same operative breast.
Exercise caution during surgical excision of the lesion to avoid cutting or damaging the Tag. When using
electrosurgical tools, avoid direct contact with the Tag as thermal damage can result. If the Tag is inadvertently
damaged, ensure all parts of the Tag are retrieved from the surrounding tissue.
When using the Surgical Probe intraoperatively, avoid touching or moving the Tag with the Surgical Probe.
Do NOT use the Tag Applicator or Surgical Probe if the package is open or damaged.
Use the Tag Applicator and Surgical Probe prior to the expiration date shown on the product label.
Tag Applicator and Surgical Probe
Table 1. Probe Specifications
3

The LOCalizer Reader is a sensitive radio receiver operating at 134 kHz. Its operation may be affected by other
devices operating near this frequency.
The LOCalizer Reader is intended for use only in a hospital, except near active HF Surgical Equipment and other
RFID equipment or wireless battery chargers.
The LOCalizer transmits RF energy at 134 kHz and is sensitive to a receive bandwidth of 120kHz to 150khz.
The LOCalizer Reader transmits a weak unmodulated magnetic eld at 134 kHz (<200 microwatts ERP) to sense the
presence of the Tag. Modulation of the eld by the Tag is detected by the LOCalizer Reader. Other devices that
generate electromagnetic elds in this frequency region may interfere with the ability of the LOCalizer to sense the
location of the Tag. Interference may occur for example from other RFID readers, inductive chargers commonly used
for cell phones or other devices, or magnetic induction proximity detectors. Sensitive devices such as other Low
Frequency RFID readers may likewise be affected by the operation of the LOCalizer Reader in the same vicinity.
ADVERSE REACTIONS
None known.
HOW SUPPLIED
The LOCalizer Reader with its integrated Loop Probe is provided nonsterile and is intended for reuse.
The Tag Applicator and LOCalizer Surgical Probe are provided sterile and are intended for single use only.
The Tag is non-pyrogenic. The RFLS is not made with natural rubber latex.
6
PRECAUTIONS
Failure to thoroughly review and adhere to the information contained in this User Manual may pose a potential
hazard to the patient and/or user and may void the warranty.
This product should only be used by a physician who is completely familiar with the indications, contraindications,
limitations, typical ndings and possible side effects of using a system for lesion localization that employs a marker
at the site of the lesion and a reader for marker retrieval.
Handle all components in a manner that will prevent accidental contamination.
General
Do NOT use the Tag Applicator if needle is bent and/or tip is damaged.
Do NOT use the Surgical Probe if it is damaged.
Do NOT remove Safety Lock from applicator until needle has been advanced to desired location for Tag deployment.
Do NOT implant Tag greater than 6 cm deep from the breast surface to accommodate the
LOC alizer Reader
detection range.
Ensure the Tag is completely deployed in the breast tissue by depressing the plunger until it contacts the
Applicator barrel.
After use, the Tag Applicator, Tag, and Surgical Probe are biohazards. Dispose in accordance with your facility's
biohazardous waste procedures.
Do NOT immerse the Surgical Probe in liquid.
Tag Applicator and Surgical Probe
The LOCalizer Reader is designed to locate the low frequency 134 kHz Health Beacons Tags. Do NOT use the
LOCalizer Reader with RFID markers other than the Health Beacons Tags. Other markers may give some response
but the detection range and accuracy may be affected. Most markers at other frequencies will not be readable.
Metal Items, such as surgical tools, that block the path between the implanted Tag and LOCalizer Probe may alter
the LOCalizer Reader readings. Ensure these items are not in the path of the Tag being read.
Ensure the LOCalizer Reader battery is fully charged prior to use. A back-up LOCalizer Reader is recommended in
the case of instrument malfunction or battery depletion.
Do NOT immerse LOCalizer Reader in liquid.
The LOCalizer Reader is sensitive to electromagnetic interference during the operation of HF Surgical Equipment
such as Electrosurgery cutting tools and instruments, and should be used non-concurrently with such equipment.
LOCalizer Reader
5

Control/
Display
Name
Display - Tag ID
Display -
Unit Indicator
Description
Displays the unit of measurement as millimeters (mm)
Displays the Tag ID
Volume
Adjustment
Increases/decreases the volume of the audible signal
Brightness
Adjustment
Increases/decreases the brightness of the display
Active Probe
Icon
Displays which Probe is currently active: Loop (left icon) or Surgical Probe (right icon)
Battery
Indicator
Indicates current battery level
The battery level decreases as the battery discharges. The symbol ashes on and off
when the battery needs replacement. When the battery reaches a critical level, the
device is disabled
Intensity
Indicator
Indicates intensity of the signal between the Probe and the Tag
The Intensity Indicator can be used alternatively to the audio tone to assess location
The selected sound and display light levels are stored when the instrument is turned off and recalled when it is
turned on again.
When the battery is critically low, the sound level is automatically lowered to extend operating lifetime.
Sound and Backlight
TAG IMPLANTATION
Refer to the Tag Applicator Instructions for Use for details regarding Tag placement and removal methods.
8
04987
Distance to Tag
Active Probe Icon
Tag ID Number
Intensity Indicator
Unit Indicator
Battery Charge
Probe Toggle
Brightness
Volume
Power On/Off
LOCALIZER READER CONTROLS
The LOCalizer Reader contains the display and controls for the System and are located on the front face of the
instrument. The LOCalizer Reader allows the user to adjust the system’s settings, and produces signals in the form
of a displayed distance in millimeters and an audible pitch that represents the intensity of a Probe’s signal.
Figure 2. LOCalizer Reader Controls and Displays (described below)
Control/
Display
Name
Power
Probe Toggle
Description
Turns power ON/OFF
To switch ON, press the power button. The system performs a self-test before it is
available for use.
To switch OFF, press the ON/OFF button.
Toggles between the Loop Probe and Surgical Probe
Display -
Distance Output
Displays the distance to the Tag in millimeters
7

Use the up and down arrows on the volume control to adjust the audio tone to the desired volume.
If excising the Tag and lesion, plan and mark the surgical area with the approximate location of the Tag.
In preparation for surgery, place the sterile LOCalizer Instrument Cover over the LOCalizer Reader per the
Instrument Cover Instructions for Use.
NOTE: The LOCalizer Reader can be used on an un-breached breast surface in a non-sterile setting. In a sterile
setting, use of the Instrument Cover is required. The Surgical Probe is only intended for sterile use.
Connect the Surgical Probe into the receptacle on the LOCalizer Reader by introducing it through the cover
connector hole. When connected, the LOCalizer Reader automatically identies the Surgical Probe as the active
probe, performs a self-test and the LOCalizer Reader screen displays the Surgical Probe icon. When the Surgical
Probe is attached, the range of LOCalizer Reader is at least 30 mm.
During the surgical approach, the LOC alizer Reader may be toggled between the Loop Probe and Surgical Probe
by depressing the probe toggle switch. The active probe is indicated on the display.
Excise intended tissue with implanted Tag.
Conrm the Tag is present in the excised specimen using the
LOC alizer Reader or imaging (ultrasound or radiography).
Figure 4. Assessing Tag location/position with Surgical Probe using signal strength (not to scale)
NOTE: Readings will vary depending on the orientation of the Tag, because the signal emitted is directional along
the long axis of the Tag. The
LOC alizer Reader will receive the strongest response and most accurate distance
reading when the Surgical Probe is parallel with the Tag. Signal strength decreases as the Surgical Probe head
moves toward perpendicular to the Tag and the distance accuracy may decrease.
5
6
7
8
9
10
11
10
Direction of decreasing response
LOCalizer Surgical Probe
parallel with Tag
Strongest response and most
accurate distance reading
LOCalizer Surgical Probe
perpendicular to Tag
Weakest or no response
LOCALIZATION PROCEDURE
Power on the LOC alizer Reader.
The rmware version number is displayed.
There is a brief delay while the integrated loop probe is tested.
If the Surgical probe is installed, there is a corresponding delay while it is tested.
Use the up and down arrows on the brightness control to adjust the screen to the desired intensity.
Check the battery charge indicator to ensure there is adequate charge. It is highly encouraged to change the
batteries before each procedure.
Batteries can be replaced following directions in the “CARE AND MAINTENANCE” section.
NOTE: The
LOC alizer Reader may turn ON with a critically low battery, but will not continue operation normally.
Use the Loop Probe on the
LOC alizer Reader to identify the general location of the Tag from the surface of
the breast. The sound level and pitch increases as the
LOC alizer Reader approaches the Tag. The scale shows the
approximate distance to the nearest point of the Tag in millimeters. When using the Loop probe the range of the
LOC alizer Reader is at least 60 mm.
Figure 3. Assessing Tag location/position with Loop Probe using signal strength (not to scale)
NOTE: The sound and distance display rise to a maximum when the Tag is in line with and directly under the
sensing head surface (Figure 3). Identication of the Tag location can be rened by moving the Probe until both
ends of the Tag are detected.
NOTE: The Tag’s unique identication number is displayed once the probe is close enough to the implanted Tag.
1
2
3
4
Direction of decreasing response
LOCalizer Reader (Loop)
Probe in line with Tag
Strongest response and most
accurate distance reading
LOCalizer Reader (Loop)
Probe perpendicular to Tag
Weakest or no response
9

Low battery
The maximum audio volume is automatically reduced to extend remaining
operational time.
Replace Batteries.
An Internal error has occurred
This is generally a permanent fatal error, and the LOCalizer Reader must be
replaced. Before returning the LOCalizer Reader for service, try removing and
replacing the battery. This may clear an error.
Battery Icon Flashing
Display shows:
Display shows:
with Probe icon.
The Selected Probe does not pass self-test
For the Surgical probe, replace the Probe
For the Loop probe, replace the LOCalizer Reader
CARE AND MAINTENANCE
As needed, use a damp cloth or sponge, with mild detergent if necessary. Do NOT use abrasives or solvents, as
these may degrade the case. Do NOT submerge the LOCalizer Reader in liquid.
Surface Care
Periodic battery replacement is necessary for the unit to continue to operate correctly. To replace batteries, open
the battery compartment by holding the textured edges and pulling rmly off the device. Install commercially
available AA batteries following the battery polarity symbols on the inside of the case. Approximate battery life
expectancy under normal use conditions is 8 hours. These times may be slightly reduced at high display intensity
and audio volume. Use only good quality AA Alkaline cells (IEC-LR6).
Batteries
12
Display shows:
“?” over Probe icon
The Selected Probe has low signal strength
System may continue to function, the range accuracy for tag reading may be
impacted. Check environment for possible sources of interference and
remove. This may occur when Probe or Reader is placed on a metal surface;
moving the Probe or Reader away clears the “?”. Check the active probe icon
to ensure the correct probe is selected.
TROUBLESHOOTING
Little or No Tag Response
Tag distance reading is incorrect
The Tag is out of LOCalizer Reader detection range
Reposition the LOCalizer Loop or Surgical Probe until a signal is detected.
The Tag signal is receiving interference from another Tag or device
Remove alternative source of signal or use alternate imaging guidance such as
ultrasound or radiography to conrm Tag location.
The Tag is broken
An alternate imaging guidance such as ultrasound or radiography should be
used to ensure the entire Tag is removed with tissue removal.
Positioning of the Reader
Resolution of system allows discrimination of two ends of Tag. Reposition the
LOCalizer Loop or Surgical Probe and look for readings from both ends of Tag.
Readings at these positions have the highest accuracy.
Tag presence is indicated
and incorrect
Interference of transmitting equipment
If a Tag detection is indicated when no Tag is within the normal detection
distance, check for other RFID readers, wireless chargers or other nearby
equipment that may be transmitting in the region of 134 kHz.
Tag location cannot be determined
Readings are difficult to interpret
Resolution of system allows discrimination of two ends of Tag. Reposition the
LOCalizer Loop or Surgical Probe and look for readings from both ends of Tag
to determine Tag location.
The LOCalizer Reader
is unresponsive
The LOCalizer Reader has a critically low battery
Replace batteries.
If new batteries fail to work, the LOCalizer Reader may have suffered a fatal error.
Contact your supplier for replacement of the unit.
Tag ID is not displayed or display
shows “ #????? ”
The Tag ID is displayed only when the Loop probe is within 40mm of the Tag
and the Surgical Probe is within 20mm. If within these limits, there may be an
interfering signal from another RFID reader, tag or wireless charger.
Check for and remove other RFID readers, tags, wireless chargers or other nearby
equipment that may be transmitting in the region of 134 kHz.
This condition may occur if multiple Tags were placed in the same operative breast
and the LOCalizer Reader can’t discern one Tag signal from the other.
Re-position the Reader in multiple locations to identify more than one Identication
number. Use the identication numbers to determine each Tag’s placement.
11

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Consult the dealer or an experienced radio/TV technician for help.
MRI Safety Information
The LOCalizer Reader is MR Unsafe. Keep away from magnetic resonance imaging (MRI) equipment.
Electromagnetic Emissions and Immunity
14
REPLACEABLE / REPAIRABLE COMPONENTS
TECHNICAL INFORMATION
There are no repairable components. With the exception of battery replacement, (Refer to Care and
Maintenance) no modication or repair of this equipment by the user is allowed.
If the
LOC alizer Reader stops working or is damaged it should be replaced.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired operation.
The user is responsible to maintain FCC compliance. Any changes or modications not expressly approved by
Health Beacons could void the user’s authority to operate the equipment.
Use the
LOC alizer Reader only with a LOC alizer Surgical Probe and Tag.
Interference
LOCalizer Reader
*For best service life of AA Alkaline Cells used in LOC alizer Reader, storage temperature should be 5° - 30°C.
To avoid potential damage from cells leaking, remove battery if the
LOC alizer Reader will not be used within
2 months.
Store the Tag Applicator and Surgical Probe at ambient temperature 15° to 30°C (59° to 86°F).
Environmental, Storage, and Transportation Conditions
Operational Conditions
Ambient
Temperature
Relative
Humidity
Temporary Storage and Transport Conditions*
30% - 75%, non-condensing
5˚ - 30˚C (41˚- 86˚F)*
Atmospheric
Pressure
70 kPa – 102 kPa
15% - 93%, non-condensing
-20° - 50°C (-4°-122°F)
50kPa - 106kPa
1
2
13

The following symbols may be found on the product labeling for the RFID Localization System:
SYMBOLS
After following the cleaning recommendations above, and there are no biohazard risks involved, dispose of the
LOC alizer Reader at the end of the LOC alizer Reader’s useable life per Waste of Electrical and Electronic
Equipment (WEEE) directive [Directive 2002/96/EC]. Dispose of Tag Applicator, Surgical Probe, and Instrument
Cover per the device Instructions for Use.
DISPOSAL OF EQUIPMENT
Symbol
Use by Date
Caution
Manufacture Date
YYYY-MM-DD Expiration date is represented by the
following:
YYYY represents the year
MM represents the month
DD represents the day
Description
Follow instructions for use
Do NOT use if package is damaged
Sterilized using irradiation (Probe)
Do NOT resterilize
Single use only
Sterilized using Ethylene Oxide
(Tag Applicator)
U.S. Federal law restricts this device to
sale by or on the order of a physician
Symbol Description
Manufacturer
Catalog Number
Batch Code
Serial Number
Type B Equipment
Temperature limitation
Humidity limitation
Device is non-sterile
Do NOT dispose of the
LOC alizer Reader
by placing into trash receptacles.
Keep dry
Self test in process
Call for Service
The LOCalizer Reader is MR Unsafe.
Keep away from magnetic resonance
imaging (MRI) equipment.
16
MR
The LOCalizer Reader is compliant to applicable emissions and immunity standards listed below.
DescriptionStandards
IEC 60601-1-2:2014
Product Family Standard
Emissions and Immunity
EN55011:2009
+A1:2010, FCC
15.109(a) & ICES-003
Security Level or Limit Criteria Test Result
Medical electrical equipment - Part
1-2: General requirements for
basic safety and essential
performance - Collateral standard:
Electromagnetic compatibility -
Requirements and tests - Edition 4
Radiated Emissions: At any one
voltage & frequency (Per table 1)
Class B Group 1.
30MHz - 1 GHz
See
Below
Limit Complies
EN55011:2009
+A1:2010, FCC
15.107(a) & ICES-003
Conducted Emissions: At any one
voltage & frequency (Per table 1)
NA, NA.
EUT is battery operated only
Limit NA
EN61000-3-2:2006
+A1:2009+A2:2009
Power Harmonics: At 230 V, 50Hz
or 60 Hz (Per table 1)
NA EUT is battery operated only Limit NA
EN61000-4-2:2009
Basic test standard
Electrostatic Discharge Immunity:
At any one voltage & frequency
(Per tables 1 and 7)
±15 kV Air Discharge
±8 kV Contact Discharge, VCP, HCP
per Annex I Complies
EN61000-4-3:2006 +
A2:2010
Basic test standard
Radiated Electromagnetic Fields
Immunity: At any one voltage &
frequency (Per tables 1 and 4)
3V/m, 80-2700 MHz at
80% 1kHz AM Modulation
per Annex I Complies
EN61000-4-3:2006 +
A2:2010
Basic test standard
Radiated Electromagnetic and
Proximity Fields Immunity:
At any one voltage & frequency
(Per tables 4 and 9)
RF wireless communication elds on
Spot Frequencies from Table 9 at
50%, Square wave Modulation 9
to 28 V/w
per Annex I Complies
EN61000-4-4:2012
Basic test standard
Electrical Fast Transient/Burst
Immunity: 100kHz at any one
voltage & frequency (Per table 1)
NA on AC or DC Mains
±1 kV SIP/SOP
EUT is battery operated only
per Annex I Complies
EN61000-4-5:2006
Basic test standard
Surge Immunity: At any one
voltage & frequency (Per table 1)
NA CM Line-Gnd
NA, DM Line-Line
NA SIP/SOP Ports are not connected
directly to outdoor cables
NA NA
EN61000-4-6:2009
Basic test standard
Conducted Immunity: At any one
voltage & frequency (Per table 7)
3V rms, 0.15 - 80 MHz
6V rms, on ISM bands
on SIP/SOP port only
per Annex I Complies
EN61000-4-8:2010
Basic test standard
Power Frequency Magnetic Field
Immunity: At any one voltage at 50
or 60 Hz (Per table 1)
30A/m @ 50Hz or 60Hz
3 orthogonal orientations
per Annex I Complies
EN61000-4-11:2004
Basic test standard
Voltage Dips and Voltage
Interruptions: At min & max rated
input voltage at any rated power
frequency (Per table 1)
NA
NA
NA
NA
EUT is battery operated only NA NA
EN61000-3-3:2013
Voltage Fluctuation: At 230 V,
50Hz (Per table 1)
NA EUT is battery operated only Limit NA
CompliesThe requirements for use in the
Professional healthcare facility
environment were chosen by the
manufacturer.
See called out basic standards below
15