SKF Matrix Series User manual

Matrix
Linear Actuator
Read this manual before installing, operating
or maintaining this actuator. Failure to follow
safety precautions and instructions could
cause actuator failure and result in serious
injury, death or property damage.
Installation, operation
and maintenance manual

1 General information ............................. 5
1.1 Information on this manual ..................... 5
1.2 Explanation of symbols ........................ 6
1.3 Limitation of liability ........................... 6
1.4 Copyright ................................... 7
1.5 Spare parts ................................. 7
1.6 Warranty terms .............................. 7
1.7 Customer service ............................. 7
2 Safety ......................................... 8
2.1 Use ....................................... 8
2.1.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.1.2 Unintended and excluded use............... 9
2.1.3 Essential performance .................... 9
2.2 Responsibility of the owner and processor .......... 8
2.3 Personnel requirements ....................... 9
2.3.1 Qualifications ........................... 9
2.4 Specific dangers .............................. 10
2.5 Safety equipment ............................. 11
2.6 Safeguard against restart ...................... 13
2.7 Changes and to the device ...................... 13
2.7.1 Warning labels .......................... 15
2.7.2 Information labels ....................... 15
2.8 Manufacturer’s declaration of EMC compliance ...... 16
3 Technical data .................................. 24
3.1 Operating conditions .......................... 24
3.2 Product label ................................ 24
4 Structure and function ........................... 25
4.1 Overview ................................... 25
4.1.1 Matrix MAX1 and MAX3 .................. 25
4.1.2 Matrix MAX6 ........................... 25
4.2 Brief description ............................. 26
4.3 Special features .............................. 27
4.4 Construction group description .................. 28
4.5 Requirement for 3rd party power supply ........... 28
4.6 Connections ................................. 29
4.7 Operating elements ........................... 30
4.8 Options .................................... 31
4.8.1 Emergency lowering device ................ 31
4.8.2 Quick adjustment ........................ 31
4.8.3 Electrical pinch protection ................. 32
4.8.4 Life span display ........................ 33
4.8.5 Mechanical pinch protection ............... 33
4.8.6 Master slave actuator function .............. 33
4.8.7 Impulse transmitter ...................... 33
4.9 Accessories ................................. 34
Contents
5 Transport, packaging and storage . . . . . . . . . . . . . . . . . . . 35
5.1 Safety information for the transport . . . . . . . . . . . . . . . 35
5.2 Transport inspection .......................... 35
5.3 Return to the manufacturer ..................... 36
5.4 Packaging .................................. 36
5.5 Storage .................................... 37
6 Installation and first operation ..................... 38
6.1 Installation location ........................... 39
6.2 Inspections prior to first operation ................ 39
6.3 Installation .................................. 41
6.4 Connection to the control Unit ................... 44
6.5 Connection to operating element ................. 47
6.5.1 Connect MAX1 and MAX3 to operating element 47
6.5.2 Connect MAX6 to operating element ......... 47
6.6 Connect to power supply ....................... 51
6.6.1 Connect MAX1 and MAX3 to power supply .... 51
6.6.2 Connect MAX6 to energy supply ............ 51
6.7 Requirements concerning the installation of the
actuators with options ......................... 54
6.7.1 Emergency lowering device ................ 54
6.7.2 Quick adjustment ........................ 55
6.7.3 Electrical pinch protection ................. 55
6.7.4 Mechanical pinch protection ............... 56
6.7.5 Master-slave actuator function ............. 56
7 Operation ...................................... 59
7.1 Safety ..................................... 59
7.2 Turn on .................................... 60
7.3 Turn off .................................... 60
7.4 Action before Use ............................. 61
7.5 Action during the operation ..................... 62
7.5.1 Normal operation ....................... 62
7.5.2 Operate emergency lowering device ......... 62
7.5.3 Operate quick adjustment ................. 64
7.6 Disengagement in case of emergency ............. 67
7.6.1 Shut down MAX1 and MAX3 ............... 68
7.6.2 Shut down MAX6 ........................ 69
7.7 Action after use .............................. 69
2

8 Maintenance ................................... 70
8.1 Maintenance plan ............................ 71
8.2 Maintenance work ............................ 72
8.2.1 Cleaning .............................. 72
8.2.2 Inspections and readings .................. 72
8.2.3 Check Sealing function of plug .............. 73
8.2.4 Check of visual condition .................. 75
8.2.5 Check options .......................... 76
8.3 Measures after completed maintenance ........... 76
9 Malfunctions ................................... 77
9.1 Malfunction table ............................. 79
9.1.1 Matrix MAX1 and MAX3 .................. 79
9.1.2 Matrix MAX6 ........................... 80
9.2 Start of operation after fixed malfunction . . . . . . . . . . . 81
10 Dismantling ................................... 82
10.1 Dismantling ................................. 83
10.1.1 Dismantling of MAX1 and MAX3 ........... 83
10.1.2 Dismantle MAX6 ....................... 83
10.2 Disposal ................................... 86
3

4

1.1 Information on this manual
This manual provides important information on how to work with
the actuator (also called device) safely and efficiently.
The Manual is part of the device, must always be kept in the
device’s direct proximity and should be available for the personnel
at any time. All personnel working with the device must read and
understand this Manual before starting any work. Strict compliance
with all specified safety notes and instructions is a basic requirement
for safety at work.
Moreover, the accident prevention guidelines and general safety
regulations applicable at the place of use of the device must also
be complied with.
For better representation of circumstances, the illustrations used
are not necessarily to scale and may vary from the actual design of
the device.
1.2 Explanation of symbols and
signal words
Safety precautions
Warnings are identified by symbols and signal words. These signal
words indicate the severity of the hazard.
Adhere to these safety precautions and act cautiously in order to
avoid accidents, personal injuries and damage to property.
1 General information
!Note!
Emphasizes useful hints and rec-
ommendations as well as information
for efficient and trouble-free operation.
Indicates a dangerous situation, which
can lead to severe personal injury or
death, if the precautionary measures
are ignored.
WARNING
Indicates a dangerous situation, which
can lead to minor or moderate injury or
property damage, if the precautionary
measures are ignored.
CAUTION
Indicates a dangerous situation, which
will lead to death or severe personal
injury, if the precautionary measures
are ignored.
DANGER
5

1.3 Limitation of liability
All information and notes in this manual were compiled under due
consideration of valid standards and regulations, the present status
of technology and our years of knowledge and experience.
The manufacturer will not be liable for damage resulting from:
• disregarding this manual
• unintended use
• employment of untrained personnel
• unauthorized conversions
• technical modifications
• manipulation or removal of the screws on the device
• use of unapproved spare parts
In case the actuator is customised, the actual product delivered may
be different from what is described in the manual. In this case, ask
SKF for any additional instructions or safety precautions relevant to
these actuators.
We reserve the right to make technical modifications to the actua-
tor to improve usability.
1.4 Copyright
This Manual is protected by copyright law and exclusively to be
used for internal purposes.
Passing this Manual on to third parties, duplication of any kind
– even in form of excerpts – as well as the use and/or disclosure of
the contents without the written consent of the manufacturer is not
permitted, except for internal purposes.
Violations oblige to compensation. The right for further claims
remains reserved.
6

1.5 Spare parts
The Matrix linear actuator is not designed for repair work. All war-
ranty and service claims become void without notice if any screws
on the linear actuator have been manipulated.
The device must be dismantled and sent to the manufacturer. The
address is listed on the cover back.
1.6 Warranty terms
The applicable and effective warranty terms are those contained in
the manufacturer’s terms and conditions of sale.
1.7 Customer service
SKF Customer Service is always available to provide technical
information and answer questions.
The contact information for SKF Customer Service can be found
on www.skf.com.
Safety hazard caused by wrong spare parts
Wrong or faulty spare parts can adversely affect
safety and cause damage, malfunctions or total
failure.
Therefore:
• Use only genuine spare parts from the manufacturer.
• Spare parts in/on the device may only be replaced by the
manufacturer.
WARNING
7

2 Safety
This paragraph provides an overview of all important safety aspects
for optimal protection of personnel as well as safe and trouble-free
operation.
Disregarding this Manual and safety regulations specified therein
may result in considerable danger and possible serious injury or
death.
2.1 Use
2.1.1 Intended use
The device has been designed and built exclusively for its intended
purpose as described in these instructions.
The device is only used for the dynamic centric compression
or tensile-loaded lift. It is only intended for interior use and is
implemented in medical devices as well as in industrial and
construction technology.
range of environmental conditions:
• Ambient temperature: 0 °C to + 40 °C
• Relative humidity : 5% to 85%
• atmospheric pressure: 700 hPa to 1060 hPa
2.1.1.1 Product life time
the linear actuators MAX are designed for a service life of 10 years
or 10 000 double strokes at a stroke length of 200 mm.
Risk from misuse
Any utilization of this device beyond its intended purpose may
lead to potentially hazardous situations.
Therefore:
• Strictly adhere to all safety precautions and instructions in this
operating manual.
• Do not make this device subject to weather conditions, strong
UV rays, corrosive or explosive air media as well as other
aggressive media.
• Do not modify, retool or change the structural design or
individual components of the actuator.
• Never use the device outside of the technical application and
operational limits.
WARNING
8

2.1.2 Unintended use
Any use other that the intended use, or modifications to the device
without the manufacturer’s written agreement, or operation beyond
the technical limits, is considered unauthorized.
Specific application exemptions are:
• Flammable anaesthetic mixture with air
• Flammable anaesthetic mixture with oxygen or nitrous oxide
• Increased radiation
2.1.3 Essential performance
the essential performance of the linear actuator MAX is moving or
holding a load within the boundaries defined by the device specifica-
tions given in this operating manual and the datasheet.
Any injury, damage or loss caused by violation of these instructions
will be the responsibility of the customer.
2.2 Responsibility of the owner
and processor
The device is designed for personal use and is also used in
commercial applications by owner or processors.
The processor is the contracting partner of the reseller or the
manufacturer. The processor installs the device in a complete system
(application).
The owner or processor of the system is therefore subject to the
requirements of the Occupational Health and Safety Act.
In addition to the safety instructions in this Manual, the owner or
processor must do the following concerning these safety and acci-
dent prevention guidelines and environmental protection regula-
tions, applicable to the site of the system’s installation:
• Inform themselves of applicable industrial safety regulations and
determine additional hazards that arise due to the specific work-
ing conditions prevailing at the site where the device is installed
using risk assessment. The risk assessment must be implemented
in the form of work instructions for device operation.
• Must confirm that the work instructions created for the system
including the device satisfy current legal requirements and must
alter the instructions if they don’t.
• Clearly regulate and specify the responsibilities for installation,
operation, maintenance, and cleaning.
• Ensure that all employees who deal with the device have read and
understood this Manual.
• Provide personnel with the required protective equipment.
• In addition, owner must train personnel at regular intervals and
inform personnel of the hazards.
!Note!
Any unauthorized use of the device can cause personal
injury and property damage. Always adhere to the instructions
given in this manual.
9

In addition, owner or processors must ensure that the device is in
adequate working condition. They must do the following:
• Ensure that the maintenance intervals described in these instruc-
tions are complied with.
• Have all safety devices inspected regularly for function and
completeness.
2.3 Personnel requirements
2.3.1 Qualifications
The following qualifications are specified for different areas of
activity listed in the manual.
• An instructed person (Operator)
has been instructed by the customer in an orientation session on
the assigned tasks and possible dangers in case of improper
behaviour.
• Qualified personnel
based on their professional training, know-how and experience as
well as knowledge of the applicable standards and regulations is
able to perform assigned work activities and to detect and avoid
possible dangers on their own.
• A professional electrician
based on his/her professional training, know-how and experience
as well as knowledge of the applicable standards and regulations
is able to perform work on electrical systems and to detect and
avoid possible dangers on his/her own.
The professional electrician has been trained for the special
location where he/she works and knows the relevant standards
and regulations.
Only persons who are expected to perform their tasks reliably are
permitted as personnel. Persons whose reaction capability is
impaired, e.g. through drugs, alcohol or medication, are not
permitted.
Improper installation, operation and maintenance can result
in serious injury, death or property damage.
Use only qualified, instructed, or trained personnel (as described
below) who have read, understand and follow these instructions.
WARNING
10

2.4 Specific dangers
The following section lists the residual risks that have been deter-
mined by the risk assessment.
• Heed the safety instructions listed here, and the warnings in
subsequent chapters of this Manual, to reduce health hazards
and to avoid dangerous situations.
Danger to life caused by electric current
Touching conductive parts causes a direct danger to life.
Damage to insulation or individual components can cause dan-
ger to life.
Therefore:
• In the event of damage to insulation, switch off the power
supply immediately and have the defective parts repaired.
• Work on the electrical system must be carried out only by
skilled electricians.
• De-energize the machine for all work on the electrical system.
• Before maintenance, cleaning or repair work, switch off the
power supply and perform lockout procedures so it cannot be
turned on again.
• Do not bridge fuses or make them ineffective. When changing
fuses, make sure you use the correct amperage.
• Keep moisture away from conductive parts. If you do not, this
can cause short circuit.
DANGER
Electric current
Electric shock hazard
Ensure that cables cannot become pinched or damaged. Check
that the mains voltage corresponds to nominal values on the
product label. Ensure that the cabling is correctly installed in
the cable channel.
Beware of damage to actuator caused by splashing or
hose-directed water. The actuators are in accordance with IP66.
Exposure to risk of damage must be prevented at all times.
WARNING
Electric shock hazard
The linear actuator MAX do not have any on/off-switch and if
required to be switched off, for example in a emergency, the
actuator must be disconnected from the control unit or the
power supply. Only this measure will de-energize the actuator.
Applications where the actuators are built in, must provide an
emergency stop switch or isolation from the mains supply on all
conductors.
WARNING
11

Crush hazard
Do not let any object or person come in contact with the push
and / or protection tube on front and rear attachment.
Risk of damage to the linear actuator caused by static and
dynamic overloading of the actuator. Do not use the actuator
beyond the permissible operating data
WARNING
Pinch hazard
When the actuator runs into fixed objects, the driving force can
cause personal injury. If the actuator is left unattended, check
that the full stroke length is free of obstacles and that there is
nobody in the stroke area. Alternatively, provide a means of
disconnecting all conductors from the mains power supply.
WARNING
Injury due to cracks and related openings in the housing
of the actuator and / or its accessories:
If the housing is damaged due to stock, beakage or heavy wear,
cease using the device and follow the dismantling instructions.
WARNING
Any side-acting forces can destroy the actuator and pose a risk
of serious injury. During the stroke, do not manipulate any of the
elements connected to the actuator.
WARNING
Danger of injury caused by moving components
Rotating and/or linearly moving components can cause severe
injury.
Therefore:
•
Do not work on or place any of your body, hands, or arms near
moving components
WARNING Moving components
12

Overload safety cut-off
Thermal fuse protection
Overload protection (optional)
2.5 Safety equipment
Integration in an emergency-stop system required
(for certain applications)
The device is only intended for installation into an an application or
system. It does not have its own operating control elements and
does not have an independent emergency-stop-function.
Install the device so that it is part of an emergency shut-off
system and can be stopped if necessary.
The emergency shut-off system has to be connected in such a
way that a disruption of the power supply or the reactivation of the
power supply after a power disruption cannot cause a hazardous
situation for persons and objects.
The emergency shut-off systems must always be freely
accessible.
!Note!
The processor decides which applications require the
installation of an emergency shut-off system.
The following safety installations may have been installed:
Matrix MAX1/Matrix MAX3
In its standard version the device does not feature an overload safety
shut-off and must be turned off via an SKF control unit. MAX11 and
MAX31 are exceptions.
Matrix MAX6
The control unit with integrated power shut-off has been installed in
the motor housing.
Matrix MAX1/Matrix MAX3
In its standard version the device does not feature a thermal fuse
protection and can be destroyed through overheating. An SKF
control unit with integrated thermal switch turns the device off in
emergencies.
Danger due to malfunctioning safety equipment
For safe operation, be sure all safety equipment is in good
working order.
Therefore:
• Always check functionality of safety equipment according to
the maintenance plan.
• Never disengage safety equipment.
• Safety equipment may never be by-passed or modified.
WARNING
13

Matrix MAX6
A thermal fuse protection has been integrated in the motor housing.
A ball screw nut converts the rotation of the gear unit into a linear
motion. If an overload occurs when the actuator is operating, a ball
detent clutch will operate, thus stopping linear motion.
Information concerning emergency lowering function, quick adjust-
ment, electrical pinch protection and mechanical pinch protection
can be found in the chapter “Structure and Function”.
2.6 Safeguard against restart
Protect MAX1 and MAX3 against a restart.
Pull the power line plug of the SKF control unit out of the
power outlet.
Protect MAX6 against restart.
Pull the power line plug (connected with connection (1) out of the
power outlet.
To prevent damage from overheating, do not try to operate
actuator until its temperature has fallen below the threshold for
the switch to operate.
CAUTION
Life-threatening situation through unauthorized restart
For work in hazard zones, there is a risk that the power supply
is turned on without prior authorization. This presents a life-
threatening situation for people in the hazard zone.
Therefore:
• Follow the information concerning the safeguarding against
re-starting of the power supply in the chapters of this
operating manual.
• Always follow the process to safeguard against a restart as
described below.
DANGER
Fig. 1
1
Emergency lowering function (optional)
Quick adjustment (optional)
Electric pinch protection (optional)
Mechanical pinch protection (optional)
14

2.7 Modifications on the device
To avoid hazardous situations and to ensure optimal performance,
do not make any changes or modifications to the device unless they
have been specifically authorized by SKF.
2.7.1 Warning labels
The following symbols and information decals can be found in the
danger zone. They refer to the immediate vicinity around their
location.
Do not hold on to the device.
(part number 0120698)
The label will be attached for specific applications, e.g. for patient
lifters.
Do not hold on to the actuator or casing tube.
Do not put body parts and objects inbetween moving parts.
Keep body parts or objects away from moving parts.
Adhere to operation instructions and warnings.
Fig. 2
Danger of injury because of illegible symbols
Over the course of time stickers and decals may become dirty or
illegible for some other reason.
Therefore:
• Keep any safety, warning and operation related decals in
legible condition at all times.
• Replace damaged decals or stickers immediately.
WARNING
15

2.7.2 Information labels
Operating label emergency lowering function.
(part number 0112420)
Operation of emergency lowering function (†Chapter 7.5.2)
Fig. 3
2.8 Manufacturer’s declaration of
EMC compliance
IEC 60601-1-2:2014 Medical Electrical Equipment, Part 1-2:
General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements
and tests
2.8.1 Instructions for use
General
Professional healthcare facility environment
Physician offices, dental offices, clinics, limited care facilities,
freestanding surgical centers, freestanding birthing centers, multiple
treatment facilities, hospitals (emergency rooms, PATIENT rooms,
intensive care, surgery rooms, except near HF SURGICAL EQUIP-
MENT, an MR system outside a RF shielded room of an ME SYSTEM
for magnetic resonance imaging)
Essential performance
The essential performance about the actuator MAX ist to keep, hold
and move weights, loads.
Danger of injury because of illegible symbols
Over the course of time stickers and decals may become dirty
or illegible for some other reason.
Therefore:
• Keep any safety, warning and operation related decals in
legible condition at all times.
• Replace damaged decals or stickers immediately.
WARNING
16

The risk management (Document L5671,0012) identify the
functions of these linear actuators.
All features or functions are performed properly. Unacceptable
risks for patients, operators or others are performed and assessed
to prevent or reduce harm.
Warning against the stacking of equipment
List of cables, Length of cables, accessories
The use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.
WARNING
The use of accessories and cables other than those for which the
actuator MAX1, MAX3 and MAX64 was designed, can signifi-
cantly degrade electromagnetic EMISSIONS and IMMUNITY
performance
WARNING
Table 2
Power cables (MAX64)
Description Plug-Type Country Drawing-No Length Comment
Straight power cable Schuko DE 140306-3500 3,5 m
Straight power cable SEV CH 140316-3500 3,5 m
Straight power cable UL USA 140355-3500 3,5 m
Straight power cable Hospital grade USA 140360-3500 3,5 m
Straight power cable British standard UK 140350-3500 3,5 m
Coiled power cable Schuko DE 140342-1500 1,2/2,2 m
Coiled power cable SEV CH 140378-1200 1,2/2,2 m
Straight power cable SEV CH 140422-3500 3,5 m Polyurethane cable
Straight power cable Schuko DE 140426-3500 3,5 m Polyurethane cable
Table 1
Connection cables (MAX1, MAX3)
Description Drawing-No Type Length
Connection cable straight Jack plug 952329-1350 2 x AWG18 & 1 X AWG24 1,35 m
Connection cable straight Jack plug 952329-2650 2 x AWG18 & 1 X AWG24 2,65 m
Connection cable coiled Jack plug 952376-0001 2 x AWG18 & 1 X AWG24 0,78 m
Connection cable coiled DIN 8p 160618 2 x AWG18 0,78 m
Connection cable straight DIN 8p 160622-2650 2 x AWG18 & 5 X AWG24 1,5 m
17

RF communications equipment
Technical description
Requirements applicable to all ME equipment and ME Systems
a) Compliance for each Emissions and Immunity standards
Emission guidance
The Linear actuator MAX1, MAX3 and MAX64 is intended for use
in the electromagnetic environment specified below.
The customer or user of the actuator should ensure that they
are used in such an environment.
Table 3
Emission tests Compliance Electromagnetic environment- guidance
Radiated electromagnetic field
emissions CISPR 14 (EN 55014)
Group 1
Radiated electromagnetic field
emissions CISPR 14 (EN 55014)
Class B ME equipment class B
b) Deviations from Standards and allowances used (MAX1 and
MAX3 only) see table 4, page 19.
c) Instruction for maintaining BASIC Safety and Essential perfor-
mance for the expected Service life
One time approved in the final application not change is allowed
due to the EMC influence.
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30cm to any part of the ME equipment. Other-
wise, degradation of the performance of this equipment could
result
WARNING
!Note!
Do not change the once installed final application due to
EMC view
This product was tested against actual conditions of frequency
wireless environment present in Europe
WARNING
18

Table 5
Enclosure port
Phenomenon Basic EMC standard
or testmethod
Immunity test levels
Professional healtcare Home healthcare
facility environment environment
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM fieldsa) IEC 61000-4-3 3 V/mf) 10 V/mf)
80 MHz – 2,7 GHzb) 80 MHz – 2,7 GHzb)
80% AM at 1 kHzc) 80% AM at 1 kHzc)
Proximity fields from RF wireless
communication equipments
IEC 61000-4-3 (→ table 10 on page 23)(→ table 10 on page 23)
Rated power frequency
magnetic fieldsd), e)
IEC 61000-4-8 30 A/mg)
50 Hz or 60 Hz
30 A/mg)
50 Hz or 60 Hz
a) The interface between the patient physiological signat simulation, if used, and the ME equipment or ME system shall be located within 0,1 m of the vertical plane of uniform field area in one
orientation of the ME equipment or ME system
b) ME equipment and ME system that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing may be performed
at other modulation frequencies identified by the risk management process. This test assesses the basic safety and essential performance of an intentional receiver when an ambient
signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies identified by the risk management process.
d) Applies only to ME equipment an ME systems with magnetically sensitive components or circuitry.
e) During the test, the ME equipment or ME system may be powered at any nominal input voltage, but with the same frequency as the test signal (†IEC60601-1-2:2014 / table 1)
f) Before modulation is applied
g) This test level assumes a minimum distance between the ME equipment or the ME system and sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the
ME equipment or ME system will be used closer than 15 cm to sources of power frequency magnetic field, the immunity test level shall be adjusted as appropriate for the minimum expected
distance.
Table 4
Deviations from Standard 5.2.2.1b)
Test type Value Sample Remark
60601-1-2:2014 9.1 Interference voltage emission
requirement 0 dB QP margin
measurement –1,8 dB / 154 kHz MAX 30 FAIL
–0,9 dB /172 kHz MAX 30 FAIL
9.2 Discontinous disturbance (clicks) emission high click rate MAX 11, MAX 30 FAIL (both actuator types)
PASS with Control unit KOM
10.4 Surges immission
requirement L-L (AC) ±1 kV, ± 2 kV MAX 11, MAX 30
N/A (only product for 24 VDC)
requirement L-PE (AC) ±1 kV, ± 2 kV MAX 11, MAX 30 N/A (only product for 24 VDC)
requirement L-L (DC) ±0,5 kV
requirement L-PE (DC) ±0,5 kV
measurement ±0,5 kV MAX 11, MAX 30 PASS with DC power
61000-6-3 9.2 Discontinous disturbance (clicks) emission high click rate MAX 11, MAX 30 FAIL (both actuator types)
PASS with Control unit KOM
Action plan according the deviations:
In the applications the MAX1 and MAX3 are operated with a Control unit supplied by mains.
Therefore we accept the deviations.
The end user must secure compliance to the applicable EMC requirements.
Immunity Test levels (IEC 60601-1-2:2014)
19

Table 6
Input a.c. power port
Phenomenon Basic EMC
standard
Immunity test levels Immunity test levels
Professional healtcare Home healthcare
facility environment environment
Electrical fast
transients / burstsa), l), o)
IEC 61000-4-4 ±2 kV ±2 kV
Surgesa), b), j), o)
Line-to-line
IEC 61000-4-5 ±0,5 kV, ±1 kV ±0,5 kV, ±1 kV
Surgesa), b), j), k), o)
Line-to-ground
IEC 61000-4-5 ±0,5 kV, ±1 kV, ±2 kV ±0,5 kV, ±1 kV, ±2 kV
Conducted disturbances
induced by RF fieldc), d), o)
IEC 61000-4-6 3 Vm) 3 Vm)
0,15 MHz – 80 MHz 0,15 MHz – 80 MHz
6 Vm) in ISM bands between
0,15 MHz and 80 MHzn)
6 Vm) in ISM and amateur radio bands
between 0,15 MHz and 80 MHzn)
80% AM at 1 kHze) 80% AM at 1 kHze)
Voltage dipsf), p), r) IEC 61000-4-11 0% UT; 0,5 cycleg)
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315° q)
0% UT; 0,5 cycleg)
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315° q)
0% UT; 1 cycle and 70% UT; 25/30 cyclesh) 0% UT; 1 cycle and 70% UT; 25/30 cyclesh)
Single phase: at 0° Single phase: at 0°
Voltage interruptionf), i), o), r) IEC 61000-4-11 0% UT; 250/300 cycleh) 0% UT; 250/300 cycleh)
a) The test may be performed at any one power input voiltage within the ME equipment or ME system rated voltage range. If the ME equipment or ME system is tested at one power
input voltage, it is not necessery to re-test at additional voltages.
b) All ME equipment and ME system cables are attached during the test.
c) Calibration for current injection clamps shall be performed in a 150 Ωsystem.
d) If the frequency stepping skips over an ISM amateur band, as applicable, an additional test frequency shall be used in the IMS or amateur radio band. This applies to each ISM and radio band
within the specified frequency range.
e) Testing may be performed at other modulation frequencies identified by the risk management process.
f) ME equipment and ME system with a d.c. power input intended for use with a.c.-to-d.c. converters shall be tested using a converter that meets the specification of the manufacturer of the
ME equipment or ME system. The immunity test levels are applied to the a.c. power input of the converter.
g) Applicable only to ME equipment and ME systems connected to single-phase a.c. mains.
h) E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
i) ME equipment and ME systems with rated input current greater than 16 A/phase shall be interrupted once for 250/300 cycles at any angle and at all phases at the same time ( if applicable).
ME equipment and ME systems with battery backup shall resume line power operation after the test. or ME equipment and ME systems with rated input current not exceeding 16 A,
all phases shall be interrupted simultaneously.
j) ME equipment and ME systems that do not have a surge protection device in the primary power circuit may be tested only at ±2 kV line(s) to earth and ±1 kV line(s) to line(s)..
k) Not applicable to class II ME equipment and ME systems.
l) Direct coupling shall be used.
m)r.m.s., before modulation is applied.
n) The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 to 6,795 MHz; 13,553 to 13,567 MHz; 26,957 to 27,283 MHz; and 40,66 to 40,70 MHz.
The amateur radio bands between 0,15 and 80 MHz are 1,8 to 2,0 MHz; 3,5 to 4,0 MHz; 5,3 to 5,4 MHz; 7,0 to 7,3 MHz; 10,1 to 10,15 MHz; 14,0 to 14,2 MHz; 18,07 to 18,17 MHz;
21,0 to 21,4 MHz; 24,89 to 24,99 MHz; 28,0 to 29,7 MHz and 50,0 to 54,0 MHz;
o) Applicable to ME equipment and ME systems with rated input current less than or equal to 16 A/phase and ME equipment and ME systems with rated input current greater than 16 A/phase.
p) Applicable to ME equipment and ME systems with rated input current less than or equal to 16 A/phase.
q) At some phase angles, applying this test to ME equipment with transformer mains power input might cause an overcurrent protection device to open. This can occur due to magnetic flux saturation
of the transformer core after the voltage dip. If this occurs, the ME equipment of ME system shall provide basic safety during and after the test.
r) For ME equipment of ME systems that have multiple voltage settings or auto ranging voltage capability, the test shall be performed at the minimum and maximum rated input voltage.
ME equipment of ME systems with a rated input voltage range of less than 25% of the highest rated input voltage shall be tested at one rated input voltage within the range.
(†IEC60601-1-2:2014 / table 1, Note c) for examples calculations.
20