Dentsply Sirona X-Smart Pro User manual

New as of:
2023-05
X-Smart® Pro+
X-Smart® Pro
Instructions for Use
English

Table of contents Dentsply Sirona
Instructions for Use X-Smart
267 98 487 D3778
D3778.201.01.02.022023-05
Table of contents
1General information......................................................................................... 6
1.1 Dear customer,............................................................................................................ 6
1.2 Contact information ..................................................................................................... 6
1.3 General information about these instructions for use.................................................. 7
1.4 Structure of the document........................................................................................... 8
1.4.1 Identification of danger levels ....................................................................... 8
1.4.2 Formats and symbols used........................................................................... 8
1.5 Scope of these instructions for use ............................................................................. 9
1.6 Warranty and liability................................................................................................... 9
1.7 Intended use................................................................................................................ 10
1.8 Target group................................................................................................................ 10
1.9 Indications for Use....................................................................................................... 10
1.10 Contraindications......................................................................................................... 10
1.11 Obligation to notify authorities..................................................................................... 10
1.12 Cyber security ............................................................................................................. 10
2Safety notices.................................................................................................. 11
3System description.......................................................................................... 13
3.1 Design of the X-Smart Pro/Pro+.................................................................................. 13
3.2 Technical data............................................................................................................. 15
3.3 Standards and approvals ............................................................................................ 17
3.4 Electromagnetic compatibility...................................................................................... 19
3.4.1 Electromagnetic emission ............................................................................. 19
3.4.2 Interference immunity ................................................................................... 20
3.4.3 Working clearances ...................................................................................... 22
3.5 Product labeling........................................................................................................... 23
4Getting started................................................................................................. 25
4.1 Transport and unpacking............................................................................................. 25
4.2 Disposal of packaging materials.................................................................................. 25
4.3 Starting the unit ........................................................................................................... 25
4.4 Switching off the unit ................................................................................................... 26
5User interface.................................................................................................. 27
5.1 Main menu................................................................................................................... 27
5.1.1 Main dialogs.................................................................................................. 27
5.1.1.1 Treatment without apex location.................................................. 27
5.1.1.2 Manual apex location................................................................... 30
5.1.1.3 Treatment with apex location....................................................... 31

Dentsply Sirona
Instructions for Use X-Smart
Table of contents
67 98 487 D3778
D3778.201.01.02.022023-05 3
5.1.2 Header and footer ......................................................................................... 33
5.1.2.1 Header......................................................................................... 33
5.1.2.2 Footer .......................................................................................... 33
5.1.3 General operating keys................................................................................. 34
5.1.3.1 Selecting the file sequence.......................................................... 34
5.1.3.2 File selection................................................................................ 35
5.1.3.3 File settings.................................................................................. 36
5.1.3.4 Automatically changing the direction of rotation .......................... 37
5.2 Settings ....................................................................................................................... 37
5.2.1 Adapting the file library ................................................................................. 37
5.2.1.1 Systems....................................................................................... 38
5.2.1.2 Sequences................................................................................... 39
5.2.1.3 My sequences.............................................................................. 40
5.2.2 Apex locator settings..................................................................................... 42
5.2.3 General settings............................................................................................ 42
5.2.4 Update .......................................................................................................... 43
5.2.5 Selection of activation method ...................................................................... 43
5.2.6 Connecting the foot control ........................................................................... 43
5.2.7 Online resources........................................................................................... 43
6Before use....................................................................................................... 44
6.1 Initial start-up and longer breaks in use ...................................................................... 44
6.2 Before each patient ..................................................................................................... 44
7Operation......................................................................................................... 45
7.1 Changing handpiece sleeve........................................................................................ 45
7.2 Changing the contra-angle handpiece ........................................................................ 46
7.3 Attaching and removing a file...................................................................................... 47
7.4 Manage "My file sequences"....................................................................................... 47
7.4.1 Adding files from "Systems/sequences" ....................................................... 47
7.4.2 Adding new files/sequences ......................................................................... 48
7.4.3 Changing/restoring the file settings............................................................... 49
7.4.4 Removing files/sequences ............................................................................ 50
7.4.5 Changing the order of the files...................................................................... 51
7.4.6 Changing the sequence name ...................................................................... 51
7.5 Changing the file / file sequence during treatment...................................................... 51
7.6 Recommendation for the treatment procedure............................................................ 52
7.7 Calibrating the drive .................................................................................................... 53
7.8 Using the finger switch ................................................................................................ 53
7.9 Operating the foot control............................................................................................ 54
7.9.1 Charging the foot control............................................................................... 54
7.9.2 Pairing the foot control with the unit.............................................................. 54

Table of contents Dentsply Sirona
Instructions for Use X-Smart
467 98 487 D3778
D3778.201.01.02.022023-05
7.10 LED ............................................................................................................................. 55
7.10.1 Adjusting the brightness................................................................................ 55
7.10.2 LED functionality ........................................................................................... 55
7.11 Conducting a cable test............................................................................................... 56
7.12 Using the apex locator................................................................................................. 56
7.12.1 Connecting the apex locator set ................................................................... 56
7.12.2 Check apex locator system........................................................................... 57
7.12.3 Distance display............................................................................................ 57
7.12.4 Setting working length and function when it is reached ................................ 58
7.12.5 Performing apex location using a file clamp ................................................. 59
7.13 Switching the torque reverse function on/off ............................................................... 60
7.14 Changing the volume .................................................................................................. 61
7.15 Signal tones................................................................................................................. 61
7.16 Perform an update....................................................................................................... 62
7.17 Replacing the battery .................................................................................................. 63
7.17.1 Battery of the unit.......................................................................................... 63
7.17.2 Foot control battery ....................................................................................... 63
7.18 Replacing the motor .................................................................................................... 63
8After use.......................................................................................................... 64
8.1 After each treatment session....................................................................................... 64
8.2 At the end of the work day........................................................................................... 64
8.3 Once per work week.................................................................................................... 64
9Reprocessing .................................................................................................. 65
9.1 Overview of the parts to be reprocessed..................................................................... 65
9.2 Reprocessing methods................................................................................................ 66
9.2.1 General reprocessing instructions ................................................................ 66
9.2.2 Cleaning and disinfection.............................................................................. 66
9.2.3 Manual maintenance..................................................................................... 68
9.2.3.1 Maintenance of mechanical parts................................................ 68
9.2.3.2 Care of the push button chuck..................................................... 68
9.2.4 Sterilization ................................................................................................... 69
9.3 Inspection, maintenance and testing........................................................................... 69
10 Maintenance.................................................................................................... 70
10.1 Lubricate the lock washer............................................................................................ 70
10.2 Replacing O-rings........................................................................................................ 70

Dentsply Sirona
Instructions for Use X-Smart
Table of contents
67 98 487 D3778
D3778.201.01.02.022023-05 5
11 Interference ..................................................................................................... 71
11.1 Error messages........................................................................................................... 71
11.2 Troubleshooting and repair ......................................................................................... 71
11.2.1 For error messages related to insulation test................................................ 71
11.2.1.1 Fitting and removing an insulation sleeve ................................... 72
11.2.2 Remedy for pairing problems with the foot control........................................ 72
12 Storage and transport conditions .................................................................... 73
13 Disposal........................................................................................................... 74
13.1 Batteries ...................................................................................................................... 75
13.2 Accessories................................................................................................................. 75

1 General information
1.1 Dear customer,
Dentsply Sirona
Instructions for Use X-Smart
667 98 487 D3778
D3778.201.01.02.022023-05
1General information
1.1 Dear customer,
We are pleased that you have equipped your practice with the product
X-Smart Pro/Pro+.
You now have a motor with state-of-the-art endodontic technology
featuring a wide range of applications: Many endodontics file settings
have already been preset. Depending on the procedure, you can
change the settings or create your own treatment programs. The X-
Smart Pro/Pro+ endodontic motor can be operated either using the
finger switch on the handpiece or the optional wireless foot control.
The X-Smart Pro/Pro+ endodontic motor also has the latest in motor
technology and apex location. It also features a wide range of torque
and speed.
These instructions for use are designed to assist you prior to initial use
and whenever you require information later on. Also observe the safety
notices to prevent personal injury and material damage. Please perform
care and cleaning based on the corresponding instructions.
We wish you a great deal of success and hope you enjoy your X-Smart
Pro/Pro+.
Your X-Smart team
1.2 Contact information
Dentsply Sirona Product service Log in to register your units and make service requests:
https://dentsplysirona.service-pacemaker.com/
Manufacturer's address Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: +49(0) 6251/16-0
Fax: +49(0) 6251/16-2591
E-Mail: [email protected]
www.dentsplysirona.com

Dentsply Sirona
Instructions for Use X-Smart
1 General information
1.3 General information about these instructions for use
67 98 487 D3778
D3778.201.01.02.022023-05 7
1.3 General information about these instructions for
use
Follow the instructions for use Please familiarize yourself with the unit by reading through these
instructions for use before putting it into operation. It is essential that
you comply with the warning and safety information listed.
Retain documents Keep the instructions for use so that they are always at hand in case
you or another user requires information at a later point in time. Save
the instructions for use on the PC or print them out.
If you sell the unit, make sure that the instructions for use are included
with it either as a hard copy or on an electronic storage device so that
the new owner can familiarize himself with its functions and the
specified warning and safety information.
"Download Center" for technical
documents
We have set up a "Download Center" or the technical documents at
dentsplysirona.com/ifu. From here, you can download these instructions
for use along with other documents. Please complete the online form if
you would like a hard copy of the instructions for use or operator's
manual. We would be happy to send you a printed copy, free of charge.
Help If you need help despite having thoroughly studied the instructions for
use, please contact your dental depot.

1 General information
1.4 Structure of the document
Dentsply Sirona
Instructions for Use X-Smart
867 98 487 D3778
D3778.201.01.02.022023-05
1.4 Structure of the document
1.4.1 Identification of danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in these operating instructions.
Such information is highlighted as follows:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily
injury or death.
CAUTION
A possibly dangerous situation that could result in minor or moderate
bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the
product or an object in its environment.
IMPORTANT
Application instructions and other important information.
Tip: Information on making work easier.
1.4.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢ Individual action step
Request for action.
see “Formats and symbols used
[→8]”
Identifies a reference to another
text passage and specifies its
page number.
● List Identifies a list.
"Command / menu item" Indicates commands, menu items
or quotations.

Dentsply Sirona
Instructions for Use X-Smart
1 General information
1.5 Scope of these instructions for use
67 98 487 D3778
D3778.201.01.02.022023-05 9
1.5 Scope of these instructions for use
Equipment options This document describes the full version of your unit. It may therefore
cover components that are not included in the unit you purchased.
These instructions for use apply to:
● X-Smart Pro (without apex location function)
● X-Smart Pro+ (with apex location function)
File terminology In this instructions for use, the terms file and endodontic file are used
synonymously.
1.6 Warranty and liability
The manufacturer guarantees that the product delivered to you (X-
Smart Pro/Pro+) was subjected to a thorough quality test before it left
the factory.
The following warranty periods are granted for the X-Smart Pro/Pro+,
starting from the date of delivery:
● 3 years for the main unit incl. foot control
● 3 years for the handpiece and cable
● 2 years for the battery
● 1 year for the contra-angle handpiece
Warranty
The warranty does not cover defective products:
● That were serviced by service technicians not authorized by the
manufacturer
● If non-original spare parts have been used
● That have been handled improperly or have been damaged while in
transit
● That have been used in a way other than described in the
instructions for use
● For which the prescribed maintenance and care was not carried out
The manufacturer reserves the right to make changes/improvements of
any kind to the product manufactured or sold by the manufacturer
without being obligated to apply these changes to products that were
manufactured or sold by the manufacturer before this time.
Exclusion of liability
The manufacturer assumes no liability whatsoever in cases involving:
● Service or repairs made by other persons who are not authorized by
the manufacturer or dealer
● Use of the X-Smart Pro/Pro+ that does not comply with its intended
use

1 General information
1.7 Intended use
Dentsply Sirona
Instructions for Use X-Smart
10 67 98 487 D3778
D3778.201.01.02.022023-05
1.7 Intended use
The device is used in dentistry to drive endodontic instruments for the
mechanical preparation of the patient’s root canal and cavity.
Some models incorporate an electronic apex locator that assists the
operator to locate the file tip inside the root canal.
1.8 Target group
This product is intended for use only by trained dental personnel in
dental practices.
WARNING
Injury to user and patients caused by improper use or user's lack of
information.
This product is intended for use only by trained dental personnel in
dental practices.
1.9 Indications for Use
The device is indicated for use when endodontic procedures are
required.
1.10 Contraindications
None known.
1.11 Obligation to notify authorities
In the European Union, operators or users must report all serious
events related to medical devices to the competent authority of the
Member State in which they are established.
1.12 Cyber security
The device is protected against security threats via the network using
the following features:
● Network connections are only possible after the network (WLAN) is
actively turned on by the user at the device.
● Network connections to the server are password protected and
encrypted.
● The device will only allow software that is specific to the device, and
with a valid checksum, to be installed.
In addition, we recommend:
● Turning off the network connection when not in use.
● Restricting physical access to the IT infrastructure of your practice or
clinic.

Dentsply Sirona
Instructions for Use X-Smart
2 Safety notices
67 98 487 D3778
D3778.201.01.02.022023-05 11
2Safety notices
Obligations of the user ● Use only fault-free materials that do not deviate from the "specified
data".
● Protect yourself, the patient and any third parties from danger. To do
this, observe the safety information.
● Observe the "intended use [→10]".
● Keep these instructions for use within reach for further reference.
Preventing the spread of infections and
cross contamination
Prevent the spread of infections and cross contamination between
patients, users, and third parties. Sterilize equipment after each patient.
Take the appropriate hygiene measures, e.g. wear protective gloves.
The technical personnel must be trained in the reprocessing of medical
devices.
WARNING
Infections and cross contamination!
Prevent infections and cross contamination between patients, users
and third parties.
➢ Before initial start-up and after every treatment, the product must
be cleaned, disinfected, lubricated and sterilized.
➢ Before sending the unit for repairs, all parts must be properly
processed (cleaned/disinfected).
➢ Prior to disassembly/disposal of the unit, all parts must be
properly processed (cleaned/disinfected).
Heating of the head of the contra-angle
handpiece
If the contra-angle handpiece is defective, the area around the
instrument head may heat up. This leads to a risk of burning the
patient's oral mucosa.
Malfunction or damage WARNING
Malfunction or damage
Discontinue use immediately in case of malfunction, failure or no
reaction of the display, unusual or different sounds or damage.
Damaged products may cause injury. Notify your dental depot or the
manufacturer.
Repair WARNING
Do not attempt to repair X-Smart Pro/Pro+ yourself. Please contact
your local authorized DS customer service for repairs.
Spare parts and accessories Use only original Dentsply Sirona parts or parts approved by Dentsply
Sirona. Safe operation is not guaranteed for parts that have not been
approved by Dentsply Sirona.
Unapproved spare parts and accessories may lead to increased
emissions or to reduced immunity to interference.
DANGER
Electrical shock
Only the power supply delivered with the unit or an authorized spare
part may be used.

2 Safety notices Dentsply Sirona
Instructions for Use X-Smart
12 67 98 487 D3778
D3778.201.01.02.022023-05
Storage conditions: Temperature: -40°C – +70°C.
Humidity: 10% - 95%.
Air pressure: 50 – 106 kPa
Operating conditions: Temperature: +15°C – +35°C.
Humidity: <80%.
Air pressure: 60 – 106 kPa
No operation over 3000 m.
Disconnection from mains power The product can be disconnected from the mains power by removing
the power supply plug.
If you have any questions, please contact your dental depot or the
manufacturer.

Dentsply Sirona
Instructions for Use X-Smart
3 System description
3.1 Design of the X-Smart Pro/Pro+
67 98 487 D3778
D3778.201.01.02.022023-05 13
3System description
3.1 Design of the X-Smart Pro/Pro+
The full version of the X-Smart Pro+ is described below. It serves as an
example for both versions (X-Smart Pro and X-Smart Pro+).
Components that are relevant for apex location (H, I, J and K) are not
part of X-Smart Pro, as this product version is not equipped with this
function.

3 System description
3.1 Design of the X-Smart Pro/Pro+
Dentsply Sirona
Instructions for Use X-Smart
14 67 98 487 D3778
D3778.201.01.02.022023-05
A User interface
B Contra-angle handpiece
C Finger switch
D Rotating handpiece sleeve
E Integrated handpiece holder
F Handpiece
G Separate handpiece holder
H File clamp (including cable)
I Lip clip cable
J Lip clip
K Apex locator adapter
L ON/OFF button
M Apex locator socket
N Power supply socket
O Wireless foot control (optional) – separate product
P Power supply unit
Parts B/C/D/H/J are type BF applied parts.

Dentsply Sirona
Instructions for Use X-Smart
3 System description
3.2 Technical data
67 98 487 D3778
D3778.201.01.02.022023-05 15
3.2 Technical data
Endodontic unit
X-Smart Pro/Pro+
Large touchscreen in inches 7
Operation with
Finger switch x
Wireless foot control x
Power supply unit
1 manufacturer Meanwell
Model GEM60I12-P1J
Operating conditions No operation over 2000 m.
Atmospheric pressure 80-106 kPa
2 manufacturer Dongguan Shilong Fuhua
Electronic Co. LTD.
Model UES60LCP2-120500SPA
Operating conditions No operation over 5000 m.
Atmospheric pressure 50-106 kPa
Mains power supply units
Power connection in V AC 100 - 240
Output voltage V DC 12
Frequency in Hz 50/60 Hz
Wireless foot control interface
Type of wireless
module
802.11 b/g/n WiFi module +BT combo module
Manufacturer /
Model number
Telit / WE310F5
Transmission stan-
dard
Wifi IEEE
802.11 b/g/n
Bluetooth Low
Energy 5
Frequency band 2412.0 – 2462.0 MHz 2402.0 – 2480.0 MHz
Transmitting power < 54 mW < 3 mW
Maximum
range (approx.)
30 m 10 m
Modulation GFSK DBPSK, DQPSK,
CCK, OFDM, 16-
QUM, 64-QAM

3 System description
3.2 Technical data
Dentsply Sirona
Instructions for Use X-Smart
16 67 98 487 D3778
D3778.201.01.02.022023-05
Safety protocol WPA2, WPA3 1 to 1 pairing / binding
with proprietary proto-
col
Additional
Information
The WLAN interface
serves the user as a
convenient alternative
for updating the
firmware of the de-
vice. An update must
be actively started by
the user. The inter-
face does not allow
clinical function.
The BLE interface can
be used to connect to
an optional foot con-
trol. In the event of an
interrupted connection
due to a low battery
level or high-fre-
quency interference,
the unit stops and re-
mains in a safe state.
The device does not require any quality of service to perform its
intended use.
Contra-angle handpiece
X-Smart 5:1 AL
Gear ratio 5:1
Maximum motor speed in rpm 15 000
Maximum operating speed in rpm 3 000
Clamping system CA
Light function x
Apex measurement function x
Insulated contra-angle handpiece x
File
X-Smart 5:1 AL
Shank diameter in mm 2.334 - 2.350
Maximum total length in mm 25
Maximum working diameter in mm
(ISO 2157)
2.1
Gripping length in mm ≥ 11
Standard ISO 1797, Type 1

Dentsply Sirona
Instructions for Use X-Smart
3 System description
3.3 Standards and approvals
67 98 487 D3778
D3778.201.01.02.022023-05 17
3.3 Standards and approvals
The X-Smart Pro/Pro+ endodontic unit was developed in compliance
with the following standards:
● IEC 60601-1 (electrical, mechanical, and software safety)
● IEC80601-2-60 (safety of dental equipment)
● IEC 60601-1-2 (electromagnetic compatibility)
● IEC62366-1 (usability)
● IEC 62304 (software process)
● ISO10993-1 (biocompatibility)
● ISO17664-1 (hygiene)
● ISO14457 (dentistry – handpieces and motors)
● IEC62471 (photobiological safety)
● IEC14971 (risk management)
X-Smart Pro/Pro+ complies with the requirements of the RoHS Directive
2011/65/EU.
0123
This product bears the CE marking in accordance with the provisions of
the Regulation (EU) 2017/745 of April 5, 2017 concerning medical
devices.
This product is a medical device.
The unit meets the requirements in accordance with CAN/CSA- C22.2
No. 60601-1 and AAMI/ANSI ES 60601-1.
Wireless module
The wireless module complies with the requirements of the Federal
Communications Commission (Part 15 of the FCC Rules).
FCC ID: RI7WE310F5
Industry Canada The wireless module meets the requirements of Industry Canada
(RSS-247).
IC ID: 5131A-WE310F5
The wireless module complies with the RED Directive 2014/53/EU.
Standards:

3 System description
3.3 Standards and approvals
Dentsply Sirona
Instructions for Use X-Smart
18 67 98 487 D3778
D3778.201.01.02.022023-05
Harmonized and non-harmonized
standard reference
articles of Directive 2014/53/EU
EN62311, EN50665:17,
EN62368-1:2014+A11:2017
3.1 (a): Health and safety of the
user
Draft EN 301 489-1 V2.2.0,
Draft EN 301 489-,17 V3.2.0,
EN 55032:2015/AC:2016,
EN 55024:2010/A1:2015,
EN 55035:217
3.1 (b): Electromagnetic compatibil-
ity
EN 300 328 V2.2.2 3.2: Effective use of the allocated
spectrum
EU-Type Examination Certificate No. E1177-210296 with Module B+C
The Telit wireless module used is a qualified design according to the
Bluetooth Qualification Program Reference Document
Declaration ID: D053356
Qualified Design ID: 107942

Dentsply Sirona
Instructions for Use X-Smart
3 System description
3.4 Electromagnetic compatibility
67 98 487 D3778
D3778.201.01.02.022023-05 19
3.4 Electromagnetic compatibility
CAUTION
Under or over instrumentation due to electromagnetic interference!
The apex locator can be affected by electromagnetic fields. This may
lead to measurement errors. Strong influence is indicated by red
flashing of the distance display.
➢ Ensure that there are no sources of electromagnetic interference
close to the device.
The following information must be observed to ensure safe operation
regarding EMC aspects.
X-Smart Pro/Pro+ complies with the requirements for electromagnetic
compatibility (EMC) according to IEC 60601-1-2:2014/AMD1:2020
X-Smart Pro/Pro+ is designed for use in environments in professional
health care facilities.
X-Smart Pro/Pro+ is hereinafter referred to as UNIT.
Essential performance: The product has no clinical functions that are
not related to basic safety and whose loss or impairment would lead to
an unacceptable risk. (IEC 60601-1-2 sub-section 5.2.1.1b)
Environment: Professional healthcare environment (IEC 60601-1-2 sub-
section 5.2.1.1a )
3.4.1 Electromagnetic emission
The UNIT is intended for operation in the electromagnetic environment
specified below.
The customer or user of the UNIT should make sure that it is used in
such an environment.
Emission measurement Conformity Electromagnetic environment - guidelines
RF emissions according to CISPR11 Group 1 The UNIT uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interfer-
ence in nearby electronic equipment.
RF emissions according to CISPR11 Class B The UNIT is intended for use in all facilities,
including residential areas and in any facilities
connected directly to a public power supply
also providing electricity to buildings used for
residential purposes.
Harmonics according to IEC61000-3-2 ClassA
Voltage fluctuations / flicker according
to IEC61000-3-3
Conform

3 System description
3.4 Electromagnetic compatibility
Dentsply Sirona
Instructions for Use X-Smart
20 67 98 487 D3778
D3778.201.01.02.022023-05
3.4.2 Interference immunity
Enclosure
Phenomenon Basic EMC standard
or test method
Interference immunity test level for profes-
sional healthcare facilities
Electrostatic discharge IEC61000-4-2 ±8kV contact
±2kV, ±4kV, ±8kV, ±15kV air
RF electromagnetic fields IEC61000-4-3 3V/m
80MHz to 2.7GHz
80% AM at 1kHz
RF electromagnetic fields in the immedi-
ate vicinity of wireless communications
equipment
IEC61000-4-3 See table "Test specifications for the immunity
of enclosure ports to RF wireless communica-
tions equipment"
Rated power frequency magnetic fields IEC61000-4-8 30 A/m
50Hz or 60Hz
Magnetic fields in the vicinity IEC61000-4-39 65A/m – 134.2kHz (2.1kHz PM)
7.5A/m – 13.56MHz (50kHz PM)
Input AC power port
Phenomenon Basic EMC standard Interference immunity test level for profes-
sional healthcare facilities
Input AC power port IEC61000-4-4 ±2kV
100kHz repetition frequency
Surges
Line to line
IEC61000-4-5 ±0.5kV, ±1kV
Surges
Line to ground
IEC61000-4-5 ±0.5kV, ±1kV, ±2kV
Conducted disturbances induced by RF
fields
IEC61000-4-6 3 V
0.15 MHz to 80 MHz
6V in ISM bands between 0.15MHz and
80MHz
80% AM at 1kHz
Voltage dips IEC61000-4-11 0% UT; 1/2 cycle
at 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions IEC61000-4-11 0% UT; 250/300 cycles