Steris Xled Surgical Lighting / Xled Surgical Lights Operating instructions

Brand
Steris
Model
Xled Surgical Lighting / Xled Surgical Lights
Type
Operating instructions
User manual
[operation & maintenance] OM202-01EN 2021-06 REVA XLED
Surgical lighting systems
Système d’éclairage chirurgical
TABLE OF CONTENTS
1. Quality requirements ...................................................................................................................................................... 4
2. Safety instructions ......................................................................................................................................................... 5
3. Symbols used ................................................................................................................................................................. 6
4. Overview ......................................................................................................................................................................... 8
5. Characteristics ............................................................................................................................................................... 10
6. Installing the sterilizable handle ................................................................................................................................... 12
7. Operation ....................................................................................................................................................................... 14
8. Cleaning / Disinfection / Sterilization ........................................................................................................................... 18
9. List of recommended spare parts .................................................................................................................................. 19
10. Quick troubleshooting guide .......................................................................................................................................... 19
11. Environmental protection .............................................................................................................................................. 19
12. Maintenance schedule ................................................................................................................................................... 19
13. Electromagnetic environment ........................................................................................................................................ 20
STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE
STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE
1. QUALITY REQUIREMENTS
The STERIS quality system holds the following certification:
ISO 13485*
For the design, manufacture, sale, installation, and after-sales service of operating tables, tabletops, transfer trolleys, and their extensions
and accessories, lighting systems, washers and disinfection units.
The XLED® lighting range has been designed in compliance with international medical electrical equipment regulations:
• IEC 60601-2-41 (EN 60601-2-41)
Particular requirements for the basic safety and essential performance of surgical luminaires
• IEC 60601-1 (EN 60601-1)
General requirements for basic safety and essential performance applicable to medical electrical equipment
• IEC 60601-1-2 (EN 60601-1-2)
electromagnetic compatibility..
Intended use:
XLED® Surgical Lighting System is a medical device intended
to illuminate the body of a patient during surgical procedures.
Indication for use
XLED® Surgical Lighting System has no indication for use,
which means that this medical device is not used to diagnose,
prevent, monitor, treat, alleviate, compensate, replace, modify
or control any clinical condition of a patient.
Clinical benefit
XLED® Surgical Lighting System does not bring any direct
positive impact on the health of the patient which would be
measurable or meaningful.
By illuminating the body of a patient in a safe and appropriate
manner during a surgical procedure, then XLED® Surgical
Lighting System will facilitate the analysis work and the surgical
work on the different anatomical regions where the surgery will
be carried out: this will have a positive impact on management
of the patient by the medical staff during surgery.
Contraindication – Undesirable side-effect – Residual risks
There is no contraindication, undesirable side-effect or residual
risks associated with the use of XLED® Surgical Lighting
System. All safety instructions related to the use of this medical
device are listed in chapter 2.
Patient target group
XLED® Surgical Lighting Systems are not directed to a particular
patient population: they are supposed to suit any type of patient,
regardless of age, anatomy, gender, etc.
Intended user
XLED® Surgical Lighting System must be used only by qualified
personnel who are authorized to practice in the healthcare
facility. This medical device shall be operated in a controlled
environment by a professional familiar with appropriate
techniques with such equipment.
Product developed for surgeons, anesthetists, nurses etc.
which are working in operating rooms, pre- anesthesia rooms,
recovery rooms.
Essential performance
XLED® Surgical Lighting System shall deliver an illumination to
operating field while limiting the associated energy.
Intended lifetime
The intended lifetime of XLED® Surgical Lighting System is set
at 10 years, provided that the conditions of use, the cleaning
and maintenance instructions listed in this user manual are
correctly followed.
Placing on the market
XLED® surgical lighting system was launched in 2012, and the
portfolio was completed in 2013 and 2017
Any utilization going beyond the aforementioned conditions is deemed to be not for intended purposes. Only the user is liable for any loss or
damage arising from this.
XLED® surgical lighting system is a Class 1 medical device and is registered with ANSM (French National Agency for the Safety of Drugs and
Healthcare Products)
* According to the version in force
Dear Customers,
STERIS would like to thank you for choosing the XLED® surgical lighting range, which has been devised to cover all your needs.
Please read these instructions carefully, to enable you to use the product as efficiently and safely as possible
Surgical lighting systems - XLED
[5]
! Warning: This device cannot be modified without the manufacturer’s authorisation.
! Any serious incident that occurs in relation to this medical device
should be reported to STERIS and the competent authority of the
member state in which the user and/or patient is established.
Operation
! Light is an energy that can potentially dry out tissue dryness. The user should adapt the
lighting level to the needs of the procedure carried out, particularly in the case of the use of a
combination of multiple projectors.
! In case of combination of multiple projectors, the utraviolet radiation can exceed the autorized
levels. The user should adapt the quantity of projectors used to the needs of procedure carried
out.
! Do not look directly at the light source, given its high intensity and the blue light in the LED.
! Surgical interventions in the face with unprotected open eyes may result in damages to the
eyes. The eyes of the patients must therefore be closed or protected during procedures.
! During the procedure, only the surgical team may touch the sterilizable handle, in order to
ensure sterility.
! Do not use the light suspension to carry or lift objects. Do not hang from the light.
! Do not use the wall-mounted power supply units for storage.
! XLED® lights are not intended for up-lighting. Do not tilt the lights upside down.
! Do not press the touch screens and the keypad with too much force using unsuitable objects.
! In some configurations, due to the presence of several hinges on the suspensions, there is a
risk of fingers being caught. Avoid placing hands near the hinges and move the extension arms
with caution.
! Avoid handling the suspensions roughly, particularly excessive shocks against the stops. The
stops are only end of travel components. Take care of the risks of collisions with surrounded
equipments when moving the extension arms.
! Avoid handling the camera handles roughly during installation, operation or removal. When
installing or removing the video camera, be careful to place it in a secure location to prevent
it from rolling, dropping and breaking. Also, to avoid scratching the lens surface, do not stand
camera up with lens side facing down.
! Do not bump the lighthead into walls or other equipment. Always use handles when positioning
the lighthead during surgical procedures, or when cleaning or servicing the XLED® surgical
lighting systems.
Installation
! Installation and integration operations should only be assigned to STERIS technicians or
qualified technicians and should be carried out according to the installation instructions
prepared by STERIS..
To view the technical description of XLED® lights, contact the STERIS-approved after-sales
support department.
! XLED® surgical light shall be considered minor surgical light. It means that XLED® surgical
lights shall mandatory be installed in operating fields with at least a combination of two
surgical lights, in order to create a surgical lighting system. This combination is fail safe, as
a minimum illuminance will be always provided to the operating area in case of single fault
condition of surgical light.
! The lighting systems should not be installed in areas subject to an explosive risk (presence of
flammable anaesthetic gases).
! XLED® surgical lighting system may not be used in the vicinity of strong magnetic fields (MRI
environment)
! XLED® surgical lights are not intented to operate in an oxygen rich-environment.
! To prevent any risk of electric shock, this appliance should only be connected to an earthed
power supply system.
! Disconnect all utilities to the surgical light before servicing. Do not install the XLED® surgical
lighting unless all utilities have been properly locked out.
! The manufacturer warranty is subject to the use of the recommended power supplies.
! It is recommended to install a wall mounted unit control when a single surgical light is installed
in the room.
! One disconnect device accessible to operator and which have mains indicator, must be
provided during the installation.
Battery backup option operation
! As required, the power supplies can be fitted out to receive the operating suite 24V⎓ backup
system.
! In the event of a mains failure, only lights with power supplies connected to a backup power
supply system will remain operational for at least 1 hour.
Maintenance
! The safety, reliability and proper operation of the lighting system can only be ascertained and
guaranteed by STERIS. Repairs or adjustments should only be assigned to STERIS technicians
or approved technicians.
! Dismantling some sub-assemblies may impact operation and safety. For example:
-In the case of a procedure on the electrical power supply,
-In the case of a procedure on the suspension arms and the balancing system
! Observe the maintenance schedules set out by STERIS and described in this document.
! Never try to adjust the suspension yourself.
! During maintenance and repair, only original parts must be used.
! No interventions may be undertaken on XLED® surgical lighting system before all electrical
power is switched off and the supplies made safe.
! No part of XLED® surgical lighting system shall be serviced or maintained while in use with a
patient.
Cleaning / disinfection / Sterilization
! Check that power to the XLED® surgical light is OFF before cleaning
! Do not attempt to clean the lighthead unless lighthead has cooled sufficiently.
! Avoid infiltration of liquids inside the lighthead or the wall-mounted control panel. This type of
infiltration is liable to affect or damage the lighting system.
! Do not use any products based on chlorine or its derivatives, because this might cause
excessive corrosion.
! Do not dismantle the suspension components (spring arms, lighthead yoke) during cleaning
procedures. Only qualified STERIS maintenance personnel are authorised to dismantle these
components.
! To ensure satisfactory Sterilization, take care not to allow any dirt to penetrate inside the
handle.
! After each Sterilization and before each additional use of the sterilizable handle:
-Check that there is no cracking and that the latch works.
-Replace the handle if it shows crack or deformation.
-Refit the handle in the light and lock by turning (click).
! Sterilizable handles should be disposed of in a similar manner to that of other hazardous
hospital waste.
! After application of disposable sterile handle, inspect it for barrier integrity; in order to detect
any split or any tear that can lead to a breach in the sterility barre
Environmental conditions
• Transport / storage: temperature 0°C-65°C, humidity 10-85% non-condensing, pressure
500 to 1060hPa, do not store outside
• Operation: temperature 10°C-40°C, humidity 10-75%, pressure 800 to 1060hPa.
! XLED® surgical system is not intented for outdoor use, and shall not be exposed to high
humidity for extented periods.
Electrical safety
! The ON/OFF switch of the power supply (see section 7) only removes power from the load
side of the system. Any system wiring located between the switch and the facilities of the
healthcare center is still energized. The disconnection of the complete system before servicing
must be carried out with a circuit breaker positionned upstream from the power supply and
from the backup unit.
! The OFF position of the local light control (keypad) and of the wall mounted light control (see
section 7) turns off control to camera and lightheads, but the XLED® surgical system is still
energized. This mode is referred to as standby. It is necessary to press the keypad or the touch
screen to ensure that the system is powered or not and ready to be used.
2. SAFETY INSTRUCTIONS
Surgical lighting systems - XLED
[6]
Local light control (keypad)
XLED
keypad
Light On/Off Light intensity indication
Increase light intensity Decrease light intensity
Activate/Deactivate ambient lighting Backup power operation indicator
XLED
camera keypad
Camera On/Off Activate auto focus / brightness
Set zoom Rotate camera
XLED
color temp
Select color temperature
Artwork for the labelling for the XLED LIGHT
580001046 indice 02
coupole couleur température caméra
PANTONE 2728C
CMJN 0,73,94,0
CMJN 0,28,93,0
CMJN 49,0,1,0
CMJN 66,30,0,0
RAL 7036
RAL7035
RAL9010
5000K
4500K
4000K
3500K
color temperature indication (if ordered)
Wall-mounted control (touch screen) icons
Navigation / Settings
Select camera menu Select lighting menu
Select maintenance menu Indication of level of selected camera function (zoom, bright-
ness, focus) / lighting (intensity)
Increase level of selected function Decrease level of selected function
On/Off
Lights
Activate/Deactivate ambient lighting Identification of light(s) (1,2 or 3) on suspension
3500K 4000K
4500K 5000K
Set of color temperature (if ordered)
Camera
21
ALL
AUTO
SAVE
2
LOAD
2
ZOOM
ROTATE
Set zoom
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Freeze image
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Memory reminder buttons (LOAD1, LOAD2, etc.)
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Save to memory buttons (SAVE1, SAVE2, etc.)
Set light intensity
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
Set focus / autofocus
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
Set white balance (automatic/manual)
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
Set Gamma (pre-setting 1/ pre-setting 2)
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Pre-configuration
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Rotate camera
MODES
Mains operation Backup battery-powered operation
Touch screen active External light control active (RS232)
Local light control active
3. SYMBOLS USED
Surgical lighting systems - XLED
[7]
Caution: consult accompanying documents Direct current
REF
Product reference
Date of manufacture
(YYYY-MM-DD) Protective earth ground
SN
Serial number
WEEE Directive: the product must be recycled Hazardous voltage Alternating current
Name and address of manufacturer Compliance with essential requirements of
European legislation Caution
This way up
65°C
0°C
Temperature limit
MD
Medical device
Fragile, handle with care
1060
500
Atmosphere pressure limitation
Handle with care
85
10
Humidity limitation
Identification labels
Surgical lighting systems - XLED
[8]
The extensive modular XLED® range is suitable for the specific needs of all types of surgery.
XLED® surgical lights offer variable color temperature, field diameter and intensity, providing operating theatre staff with effective lighting of the
surgical field and patient.
They are equipped with built-in ambient lighting as standard..
An XLED® surgical lighting system consists of one or more lights among 4 different sizes, available in single and dual cardanic versions (according to the
specifications in the table below), with or without HD video wiring.
4. OVERVIEW
Fixed color temperature
Common range characteristics Single cardanic Dual cardanic
XLED® SINGLE SPOT
Technology White LEDs
Ambient lighting ≈100 Lx
Power supply 24V
XLDV1SS
Span 490 mm
Number of LEDs 20
Power consumption 25W
XLED® 2 SPOTS
XLDV2SF XLDV2SC XLDV2DF XLDV2DC
Span 665 mm
Number of LEDs 40
Power consumption 50W (+5W with camera)
Span 665 mm
Number of LEDs 40
Power consumption 50W (+5W with camera)
XLED® 3 SPOTS
XLDV3SW XLDV3SC XLDV3DW XLDV3DC
Span 695 mm
Number of LEDs 60
Power consumption 70W (+5W with camera)
Span 695 mm
Number of LEDs 60
Power consumption 70W (+5W with camera)
XLED® 4 SPOTS
XLDV4SW XLDV4DW
Span 785 mm
Number of LEDs 80
Power consumption 85W
Span 785 mm
Number of LEDs 80
Power consumption 85W
Surgical lighting systems - XLED
[9]
Fixed color temperature
Common range characteristics Single cardanic Dual cardanic
XLED® SINGLE SPOT
Technology White LEDs
Ambient lighting ≈100 Lx
Power supply 24V
XLDV1SS
Span 490 mm
Number of LEDs 20
Power consumption 25W
XLED® 2 SPOTS
XLDV2SF XLDV2SC XLDV2DF XLDV2DC
Span 665 mm
Number of LEDs 40
Power consumption 50W (+5W with camera)
Span 665 mm
Number of LEDs 40
Power consumption 50W (+5W with camera)
XLED® 3 SPOTS
XLDV3SW XLDV3SC XLDV3DW XLDV3DC
Span 695 mm
Number of LEDs 60
Power consumption 70W (+5W with camera)
Span 695 mm
Number of LEDs 60
Power consumption 70W (+5W with camera)
XLED® 4 SPOTS
XLDV4SW XLDV4DW
Span 785 mm
Number of LEDs 80
Power consumption 85W
Span 785 mm
Number of LEDs 80
Power consumption 85W
Variable color temperature
Common range characteristics Single cardanic Dual cardanic
XLED® SINGLE SPOT
Technology White LEDs
2 warm LEDs, 2 cold LEDs
Ambient lighting ≈100 Lx
Power supply 24V
XLDV1SST
Span 490 mm
Number of LEDs 20
Power consumption 20 W
XLED® 2 SPOTS
XLDV2SFT XLDV2SCT XLDV2DFT XLDV2DCT
Span 665 mm
Number of LEDs 40
Power consumption 30 W (+5W with camera)
Span 665 mm
Number of LEDs 40
Power consumption 30 W (+5W with camera)
XLED® 3 SPOTS
XLDV3SWT XLDV3SCT XLDV3DWT XLDV3DCT
Span 695 mm
Number of LEDs 60
Power consumption 55 W (+5W with camera)
Span 695 mm
Number of LEDs 60
Power consumption 55 W (+5W with camera)
XLED® 4 SPOTS
XLDV4SWT XLDV4DWT
Span 785 mm
Number of LEDs 80
Power consumption 60 W
Span 785 mm
Number of LEDs 80
Power consumption 60 W
Surgical lighting systems - XLED
[10]
Optical characteristics for fixed color temperature lightheads:
Characteristics (measured when the light is cold) Unit 1 spot 2 spots 3 spots 4 spots
Small
pattern
Fixed Pattern Wavelens (lens in phase)
Central illuminance measured at 1 m (Ec) (+/-10%)
Lux
90,000 110,000 160,000* 160,000*
Color temperature (+/-6%)
K
4,400
Ra Color rendering index (+/-6%)**
95
R9 Red rendering index (+/-6%)**
97
d50 light field diameter at 50% Ec min (+/-10%)
cm
8.8 13.5
d10 light field diameter at 10% Ec min (+/-10%)
cm
16 25
Spectral irradiance
W/m²
330 455 603 607
Depth of illumination (L1 + L2 at 60% Ec) (+/-6%)
cm
58 65.9 63.8 51.0
Depth of illumination (L1 + L2 at 20% Ec) (+/-6%)
cm
148 123 114 106
Shadow dilution with 1 mask (+/-10%)
%
11 44 51 65
Shadow dilution with 2 mask (+/-10%)
%
43 45 46 51
Shadow dilution with 1 tube (+/-10%)
%
100 94 93 78
Shadow dilution with 1 mask and 1 tube (+/-10%)
%
11 35 44 42
Shadow dilution with 2 masks and 1 tube (+/-10%)
%
43 42 42 33
Life span (L70 up to 30% loss of illumination)
hrs
50,000
*0/-10% ** Maximum 100
Camera characteristics:
Number of effective pixels Approx. 4.080.000 pixels
Video signal FULL HD: 1080i/60, 1080p/60
Digital zoom 16x (160x with optical zoom)
Recommended lighting levels 100 to 100,000 lux
S/N ratio 50 dB or more
Electronic shutter speed 1/1 to 1/10000 sec.
Focus Automatic / manual
White balance Auto WB/Manual WB
Gain Auto/Manual (-3 to +18 dB)
Video output HD: (Y/Pb/Pr)
Storage temperature/humidity -20 to +60°C (-4 to +140°F)/20 to 95%
Operating temperature/humidity 0 to 45°C (32 to 113°F)/20 to 80%
5. CHARACTERISTICS
Electrical characteristics:
(for XLED
®
surgical lights installed with XRP or XWP power supply)
Mains
100-120/220-240 VAC 50/60 Hz
500 VA max (power supply unit) - 150 VA (backup unit)
Protection
Class I
Fuse
(power supply
unit)
Mains: 1xT6.3A, 250V, 6.3x32 BC1500A
F1, F2: F16A, 6.3x32, 500V BC1500A (rectifier board)
F3, F4: F8A, 5x20, 250V BC1500A (rectifier board)
F5: T0.5A, 5x20, 250V BC1500A (rectifier board)
F6: F0.5A, 5x20, 250V BC1500A (rectifier board)
F1: FF10A, 6.3x32, 500V BC10 kA (switch board)
Fuse
(backup unit)
1xF16A, 230V, 10.3x25.8 BC 6kA (external)
1xF4A, 5x20, 250V BC1500A (charger board)
Batteries
2x12V 24Ah Sealed lead
Standalone
operation
Min. 1h30
Charge/discharge
indicator
Indicators on backup unit
Operation continuous
Liquid tightness IP63 (only for lighthead positioned in normal condition of use)
Surgical lighting systems - XLED
[11]
Characteristics (measured when the light is cold) Unit 1 spot 2 spots 3 spots 4 spots
Small
pattern
Fixed Pattern Wavelens (lens in phase)
Central illuminance measured at 1 m (Ec) (+/-10%)
Lux 90,000 110,000 160,000* 160,000*
Color temperature (+/-6%)
K 3,500 - 4,000 - 4,500 - 5,000
Ra Color rendering index (+/-6%)** 3500K
95
Ra Color rendering index (+/-6%)** 4000K
95
Ra Color rendering index (+/-6%)** 4500K
95
Ra Color rendering index (+/-6%)** 5000K
95
R9 Red rendering index (+/-6%)** 3500K
91
R9 Red rendering index (+/-6%)** 4000K
97
R9 Red rendering index (+/-10%)** 4500K
97
R9 Red rendering index (+/-10%)** 5000K
97
d50 light field diameter at 50% Ec min (+/-10%)
cm 7 10.5
d10 light field diameter at 10% Ec min (+/-10%)
cm 13 19
Spectral irradiance
W/m² 333 404 582 588
Depth of illumination (L1 + L2 at 60% Ec) (+/-6%)
cm 43 54,5 50 42
Depth of illumination (L1 + L2 at 20% Ec) (+/-6%)
cm 148 123 104 107
Shadow dilution with 1 mask (+/-10%)
% 7 43 49 59
Shadow dilution with 2 masks (+/-10%)
% 23 44 46 54
Shadow dilution with 1 tube (+/-10%)
% 100 95 93 78
Shadow dilution with 1 mask and 1 tube (+/-10%)
% 7 37 40,5 41
Shadow dilution with 2 masks and 1 tube (+/-10%)
% 37 42 42 41
Life span (L70 up to 30% loss of illumination)
hrs 60,000
*0/-10%
** Maximum 100
Optical characteristics for variable color temperature lightheads:
Surgical lighting systems - XLED
[12]
“Clic”
X2
“Clic”
X2
a b
cd
(4)
“Clic”
(1)
(1)
(1)
(2)
(2)
(1)
(3)
a) Installing / removing the sterilizable
handle
1) Set-up
Insert the sterilizable handle (1) onto its mount
(2) and orient it by turning it until you hear a
“click” indicating that the handle is in place.
2) Removal
To remove the sterilizable handle (1) from the
light, keep the push-button (3) pressed down
while pulling the handle downwards, to remove it
from its mount (2).
b) Installing a STERIS disposable handle
1) Insert the STERIS adapter (reference XADSTE)
(4) onto the light until you hear a “click”
indicating that it is securely in place.
2) Screw the STERIS handle (reference LB20)
completely onto the adapter.
3 - 4) Insert the disposable sterile handle onto
the STERIS light handle (reference LB53).
c) Installing a DEVON disposable handle
1) Insert the DEVON handle (reference
31146619) onto the light until you hear a “click”.
2) Screw the 2 DEVON handle securing screws
completely on the light.
3 - 4) Insert the disposable sterile handle
(reference LT-F01B) onto the DEVON light
handle.
NON-CAMERA-READY LIGHTHEADS
6. INSTALLING THE STERILIZABLE HANDLE
Surgical lighting systems - XLED
[13]
Montage poignée STERIS sur
adaptateur 2/3
c
Montage poignée STERIS sur
adaptateur 3/3
d
c.1) Installing a STERIS US handle
1) Insert the adapter (reference P136820088) onto the light by aligning the adapter pin (c)
with that of the
recess. (d)
2) Screw the top part (e) of the adapter completely.
3) Insert the STERIS handle and screw it onto the adapter to secure it in place.
4) Insert the STERIS disposable sterile handle (reference LB53).
4) Insert the disposable sterile handle.
c.2) Installing a DEVON handle
1) Insert the handle (reference 50001200) onto the light by aligning the handle pin with that of the recess.
2) Screw the handle completely.
3 and 4) Insert the disposable sterile handle (reference LT-F01B).
ergot STERIS
(d)
(c)
1) Align the vertical piece (a) with the recess (b)
; this ensures that the system connectors are aligned.
Then fit the camera onto the light.
2) Screw the camera completely.
3) For each procedure, insert the disposable sterile handle (reference LB54). Only use disposable sterile handles
supplied by STERIS.
ergot cam
(b)
(a)
(a)
a b c
a) Installing a STERIS sterilizable handle
1) Insert the STERIS adapter (supplied with the light) onto the light.
2) Screw the STERIS adapter completely.
3) Insert the sterilizable handle (supplied with the light) onto the adapter until you hear a “click” indicating that it is securely in place.
Montage poignée stérilisable
sur adaptateur 1/2
Montage poignée stérilisable
sur adaptateur 2/2
“Clic”
a b c
a
(c)
Montage poignée STERIS sur
adaptateur 1/3
b
Montage poignée DEVON sur
adaptateur 3/4
Montage poignée DEVON sur
adaptateur 4/4
Montage poignée DEVON sur
adaptateur 1/4
Montage poignée DEVON sur
adaptateur 2/4
a b c d
Montage poignée STERIS sur
adaptateur 1/3
(e)
CAMERA-READY LIGHTHEADS
b) Installing the camera (reference LMH0010X not supplied with the light)
Surgical lighting systems - XLED
[14]
7. OPERATION 1) Wall-mounted unit:
2) Remote power supply in service
room +Wall-mounted touch panel in
theatre
Service room
Op. theatre
Touch screen
27,82
25,81
280,95
R=9,49
132,70
115,41
425
351,12
73,92
55,84
147,64
175,54
117,50
Touch screen
On/Off
General light operation
Power
supply
Mains
sans camera 1 coupole sans camera 2 coupoles
fonctionnement sur secours
2 cameras, 3 coupoles
ambiance sur coupole 1
uniquement, les autres eteintes
commande en cours depuis la
coupole 1 seule allumée
ex. cam1 ex. cam2
autofocus (ON), Bright manuel
Auto white balance (ON)
commande en cours coupole
1depuis prise RS232
commande en cours coupole 1
depuis Bluetooth
éclairage sur coupole 1
uniquement sur secours
activation «bt+»
éclairage sur coupole 1 sur
secours
Batteries
Control
active
GUI
Light keypad
RS232
Operating fault
Camera connection
Navigation
Lighting
Lighting menu
On/Off
Number and position
of active lights:
1 lowest
2 middle
3 highest
(for a triple
configuration)
Ambient light on/off
Light settings
Double light version
Double light version + camera + temperature
adjusment color
1
2
1
2
3500K 4000K 4500K 5000K
Version with
single light
Version with
triple light
+camera
Temperature
adjustment color:
3500K
,
4000K
,
4500K
,
5000K
3500K 4000K
4500K 5000K
a) Use of wall-mounted light control
First of all, it is necessary to ensure that the light has been switched on. The On/Off switch is located
on the side of the wall-mounted unit if it is in the theatre (1); on the remote power supply in the service
room (2).
The light control is activated by pressing the touch screen: if the screen lights up, this indicates that
the power supply is in normal operating mode.
When you press , the light in question lights up progressively until it stabilises at the last value
stored in memory (illuminance value and color temperature (if option ordered) when light was last
switched off).
Lighting intensity is adjusted using / for the light in question. The bar graph indicates the
current lighting level .
It is possible to switch to ambient lighting mode by pressing ; to return to surgical lighting mode,
simply press again.
b) If adjustable color temperature
(if ordered)
The color temperature is adjusting using
3500K 4000K 4500K 5000K for the set of lights.
The cursor 4000K indicates the current selected
color temperature.
Surgical lighting systems - XLED
[15]
Zoom
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Freeze
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Auto focus, auto
brightness & zoom out
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Memories
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Rotate
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
21
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
ZOOM
ROTATE
Camera settings
Automatic setting
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
Brightness
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
White balance
Automatic/manual
AUTO
BRIGHT
21
AUTO Set
WB
WB
Gamma
AUTO
FOCUS
Focus
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
Gamma
Scroll through
3 pre-recorded values
AUTO
BRIGHT
21
AUTO
Set
WB
WB
Gamma
AUTO
FOCUS
Camera menu 2 (page 2/2)
Camera menu 1 (page 1/2)
ALL
AUTO
SAVE
2
LOAD
2
SAVE
1
LOAD
1
1
2
ZOOM
1/2
AUTO
BRIGHT
1
2
AUTO
WB
Set
WB
Gamma
AUTO
WB
FOCUS
2/2
Navigation
Camera
pages 1&2
1
2
1
2
3500K 4000K 4500K 5000K
c) Use of the service menu
If the option is installed, 2 separate buttons
can be used to test the backup battery system
connected to the light:
- Pressing automatically switches to backup
mode for 5 sec and returns to normal mode,
making it possible to check that the switch
works properly.
- Pressing switches to backup mode until it
is pressed again, making it possible to check the
battery standalone operating time. The system
must be returned manually to normal mode; the
user should take care to perform this procedure
at the end of the test, otherwise, the batteries
may be discharged excessively and the lighting
may be switched off even when the mains power
is present.
- During these tests, the indicator light
sans camera 1 coupole sans camera 2 coupoles
fonctionnement sur secours
2 cameras, 3 coupoles
ambiance sur coupole 1
uniquement, les autres eteintes
commande en cours depuis la
coupole 1 seule allumée
ex. cam1 ex. cam2
autofocus (ON), Bright manuel
Auto white balance (ON)
commande en cours coupole
1depuis prise RS232
commande en cours coupole 1
depuis Bluetooth
éclairage sur coupole 1
uniquement sur secours
activation «bt+»
éclairage sur coupole 1 sur
secours
switches to on the screen, and the yoke
control indicator light flashes orange.
- The operating setting button can be used to
edit the various data on the light and is intended
for STERIS qualified personnel.
Service menu
CHECK
1
2
Navigation
STERIS
service
sans camera 1 coupole sans camera 2 coupoles
fonctionnement sur secours
2 cameras, 3 coupoles
ambiance sur coupole 1
uniquement, les autres eteintes
commande en cours depuis la
coupole 1 seule allumée
ex. cam1 ex. cam2
autofocus (ON), Bright manuel
Auto white balance (ON)
commande en cours coupole
1depuis prise RS232
commande en cours coupole 1
depuis Bluetooth
éclairage sur coupole 1
uniquement sur secours
activation «bt+»
éclairage sur coupole 1 sur
secours
Backup battery
switch test
Backup battery
standalone
operation test
Access to operating
setting
Maintenance settings
d) Use of the camera menu
Surgical lighting systems - XLED
[16]
e) Use of local light control
In addition, direct local control of the light is possible using the keypad located on the light yoke.
The light is switched on by pressing (1)
The light intensity level is adjusted using (2) and (3): the light intensity level indicator (6) includes
5 LEDs, 4 of which light up to a half-level and then fully, indicating the 9 possible lighting levels for the
light. It is possible to set the level by pressing the button several times in succession or by holding the
button down until the desired lighting is obtained.
Pressing (4) switches to ambient lighting or returns to surgical lighting if previously switched off.
If the backup battery option is installed, the indicator light (5) lights up in the event of a mains outage
and switching to the backup battery.
The light performances are thus retained for at least 1 hour in this mode.
Controlling simultaneously several light heads
When two or three light heads are ON, all light heads are turned off by pressing shortly and simultaneously
on (1) and (3) on one of the light heads that is ON.
When two or three light heads are OFF, all light heads are turned on by pressing shortly and simultaneously
on (1) and (3) on one of the light heads that is OFF.
When two light heads (1 and 2) are on ambient light and the third one is on normal lighting, all light heads
return to normal lighting by pressing shortly and simultaneously on (1) and (4) on light head 1
or on light head 2.
When two light heads (1 and 2) are on normal lighting and the third one is on ambient lighting, all light
heads switch to ambient lighting by pressing shortly and simultaneously on (1) and (4) on light
head 1 or on light head 2.
3
4 1
5
2 6
The camera is switched on by pressing (13); this is indicated by the indicator light (7).When the
camera is switched on, it performs auto-focus, auto-brightness, and the zoom is at the same setting as
the last time the camera was switched off.
The zoom is adjusted using (9) and (10): the setting may be made by pressing several times in
succession or by pressing the button down until the desired zoom level is obtained.
Pressing (8) switches to auto focus/brightness and sets the zoom to minimum or restores manual
setting if previously switched off.
Rotation is adjusted using (11) and (12): the setting may be made by pressing several times in
succession or by pressing the button down until the desired tilt is obtained.
f) Use of the adjustment temperature color option (if ordered)
The color temperature is adjusted using (7) : the color temperature indicator (8) includes 4 LEDs, 4 of
which light up, indicating the 4 possible color temperature levels for the light. It is possible to set the level
by pressing the button several times in succession until the desired color temperature is obtained.
1
5 6
2
3
4 7 8 1113
12
9
10
5000K
4500K
4000K
3500K
Artwork for the labelling for the XLED LIGHT
580001046 indice 03
coupole couleur température caméra
PANTONE 2728C
CMJN 0,73,94,0
CMJN 0,28,93,0
CMJN 49,0,1,0
CMJN 66,30,0,0
RAL 7036
RAL7035
RAL9010
3 1 2 5 8 1113 9
7
6
412 1514
10
Artwork for the labelling for the XLED LIGHT
580001046 indice 02
coupole couleur température caméra
PANTONE 2728C
CMJN 0,73,94,0
CMJN 0,28,93,0
CMJN 49,0,1,0
CMJN 66,30,0,0
RAL 7036
RAL7035
RAL9010
5000K
4500K
4000K
3500K
2 3
6
5 7 8
4 1
g) Use of the HD Camera Ready option (if ordered)
h) Use of the adjustment temperature color option (if ordered)
The color temperature is adjusted using (14) : the color temperature indicator (15) includes 4 LEDs,
4 of which light up, indicating the 4 possible color temperature levels for the light. It is possible to set
the level by pressing the button several times in succession until the desired color temperature is
obtained.
Surgical lighting systems - XLED
[17]
It is important to pre-position the light prior to any procedure so as to minimise subsequent adjustments. Satisfactory pre-positioning suitable for
each operation will make it possible to reduce potential interactions with any obstacles (serum stand, equipment management system, etc.).
The light can be moved using the central handle on the light (1). The end of the light cradle (3) can also be used to handle the appliance outside
the sterile area.
The degree of freedom of the main arms (360° horizontally, except in the case of cameras or monitors) associated with the spring arms
(360° horizontally, 75° or 95° vertically), enables optimal three-dimensional movement of the light.
The recommended distance between the light and the surgical field should be approximately 1 m, to obtain optimal lighting.
i) Positioning the light
Handle blocked to the right,
Wavelens OFF, the spot size is
set to minimum.
Handle blocked to the left,
Wavelens ON, the spot size is
set to maximum.
At the end of each spot, an
ambiance LED provides low
ambient light suitable for working
with screens (endoscopic
procedures).
Press to switch on and return
to the previous mode.
In this mode, the other LEDs are
switched off.
Note: the Wavelens function
is maintained on the 3 spot
lightheads when the camera is in
position.
j) Adjusting the light
k) Adjusting the light spot size
XLED®3 and XLED®4 lightheads are equipped with the Wavelens system for varying the light spot size on the field by turning the central handle.
l) Switching on ambient lighting
>360°
>360°
310°
+45°
-50°
>360°
320°
XLED®4 spot dual cardanic lighthead
e.g. XLDV4DW
a
c
>360°
>360°
>360°
310°
+30°
-45°
c
XLED®1 spot single cardanic lighthead
e.g. XLDV1SS
a
Surgical lighting systems - XLED
[18]
The user should contact the sanitary specialists of the facility to ensure
compliance with national hygiene and disinfection requirements
(standards and directives). The recommended products and procedures
should be applied. If in doubt regarding of the compatibility of the active
substances to be used, contact the local STERIS after-sales support
department.
8.1 CLEANING AND DISINFECTING THE LIGHT:
Before any cleaning, check that the light has been switched off and
has cooled down.
Wear the recommended personal protective equipment (gloves,
goggles).
General cleaning, disinfection and safety instructions:
- Remove the sterilizable handles.
- Clean the lighting system and the suspension using a surface
detergent and follow the manufacturer’s dilution and temperature
recommendations.
- Rinse using a well-wrung cloth, wipe and leave to dry.
- Apply a disinfectant evenly, according to the manufacturer’s
recommendations.
- Leave to dry.
- Rinse using a moistened cloth, to remove any residual product.
Cleaning the lighting surface
- Check that the light has been switched off and has cooled down
sufficiently.
- Wear rubber gloves.
- Prepare a disinfectant or cleaning solution intended for plastic materials
(PC/PMMA).
- NEVER SPRAY ANYTHING directly onto the light. Moisten a soft cloth using
cleaning solution and squeeze out the excess moisture.
- Scrub the surfaces to be cleaned thoroughly.
- Rinse all the surfaces using a well-wrung clean soft cloth and clear water.
- Wipe all the surfaces with clean and dry soft cloth.
- Make sure that the sterilizable plastic handle (if used) is sterilized using a
standard hospital cycle.
Cleaning the touch screens
- Switch off the wall-mounted unit or the touch screen.
- Wipe it using a compress (or non-woven equivalent) soakedin a
detergent - disinfectant solution, and well wrung.
- Allow to dry.
Examples of recommended products
STERIS recommends the use of cleaning and disinfectant chemicals
whose compounds are based on isopropyl alcohol (<45%) or based on
a quaternary ammonium.
The use of cleaning chemicals not listed by STERIS is not recommended
because the compatibility and the effectiveness of the chemicals have
not been demonstrated.
Products which are not recommended
Glutaraldehyde, phenol, Iodine, bleach solution, ethanol, Betadine®.
8.2 CLEANING AND STERILIZING STERILIZABLE HANDLES
8.2.1 PREPARATION BEFORE CLEANING
Immediately after using the handle, take a soft cloth to clean external
dirt. Store the handles in a location allowing them to be kept moist,
to facilitate future cleaning. Take care to arrange so as to prevent any
internal soiling.
8.2.2 CLEANING
- Immerse the handles in a detergent solution.
- Follow the manufacturer’s recommendations.
8.2.3 INSPECTING CLEANLINESS
- During cleaning, regularly inspect the handles for cleanliness, toensure
that no internal or external soiling remains.
- Otherwise, repeat the cleaning process or use an ultrasonic cleaning
process.
- Rinsing: remove the detergent solution completely, rinsing with plenty of
clean water.
8.2.4 DRYING
- Wipe the handle using a lint-free clean cloth.
- Before use, the handles should undergo steam Sterilization.
8.2.5 STERILIZATION
The previously cleaned handles should undergo steam Sterilization,
according to the following instructions and cycles:
Country Sterilization cycle Temperature Time
[min]
USA &
Canada
Gravity 250°F
121°C
30
USA &
Canada
Pre-vacuum 270°F
132°C
4
USA &
Canada
Pre-vacuum 275°F
135°C
3
France ATNC (Prion) (Pre-vacuum) 134°C 18
Other
countries
Pre-vacuum Comply with national
regulations
- Ensure that each handle is clean before continuing the process.
- Wrap the handles in Sterilization wrap (double wrap or equivalent).
- The handles can also be packed in paper/plastic Sterilization bags,for
easier identification and reuse.,
- Place the handles, with the opening facing down, on the sterilizer trays.
- Attach the biological and/or chemical indicators for monitoring the
Sterilization process, according to current regulations.
- Start the Sterilization cycle, according to the sterilizer manufacturer’s
instructions.
This sterilizable plastic handle has a limited lifetime expectancy because
of the sterilization cycles it will undergo.
As a consequence, after each sterilization and before each additional
use of the sterilizable handle:
- Check that there is no cracking and that the latch works.
- Replace the handle if it shows crack or deformation.
- Refit the handle in the light and lock by turning (click)
8.3 CLEANING THE CAMERA MODULE
The compact camera is protected in an aluminium housing with urethane
moulding. A glass lens produces a clear video image while preventing
dust or fluids from entering.
The HD camera module contains sensitive electronic components liable
to be damaged if immersed in a liquid or exposed to temperatures in
excess of 50°C. The camera module is thus not suitable for Sterilization
using steam or using a liquid. However, the outer surface may be cleaned
with chemicals recommended by STERIS.
8. CLEANING / DISINFECTION / STERILIZATION
Surgical lighting systems - XLED
[19]
9. LIST OF RECOMMENDED SPARE PARTS
REFERENCES DESCRIPTIONS
XHAND5 Kit of 5 XLED® sterilizable handles
XADSTE STERIS Harmony disposable sterile handle mount adapter
LB20
STERIS Harmony disposable sterile handle mount for non
camera ready lightheads
LB53 4 packs of 30 STERIS Harmony disposable sterile handles
31146619 DEVON disposable sterile handle mount non camera ready
lightheads
REFERENCES DESCRIPTIONS
LT-F01B Pack of 100 DEVON disposable sterile handles
LMH0010X
STERIS HD camera handle
LB54 Pack of 30 STERIS HD camera disposable sterile handles
50001200 DEVON disposable sterile handle mount for camera-ready
lightheads
P136820088
LB20 disposable sterile handle mount for camera-ready
lightheads
FAULT OBSERVED POSSIBLE CAUSE CORRECTIVE ACTION
Light does not switch on
- Mains power outage
- Check that the On/Off switch is switched on
- Check whether another appliance is running on the same system
- Other cause - Call the STERIS servicing department
Not all the lights are switched on
- There is an individual control for each light - Check that the power supplies are switched on
The sterilizable handle does not insert into
the mount correctly
- Sterilization setting overshoot (temperature,
time)
- Check that the locking mechanism (audible click) and the handle
assembly are working
- The maximum service life has been exceeded/
the handle is deformed
- Replace the handle
Light deviation
- Suspension tube verticality defect
- Unstable ceiling structure
- The brakes are not fastened tightly enough
- Check the verticality and ceiling structure
- Call the STERIS servicing department
- Adjust the locks
Light too flexible or too hard to handle
- Incorrect brake setting
- Lack of lubrication
- Adjust the balancing system
- Call the STERIS servicing department
The video camera system is not responding to
controls on the wall-mounted lighting unit
- Incorrect wiring
- Faulty wiring
- Check the connection of the HD video cable
- Call the STERIS servicing department
Poor-quality video image
- Incorrect settings
- Poor connection
- Restore the default camera settings
- Check the connectors at the rear of the wall-mounted unit
- Check that the signal source is functioning
In the event of a repeated or major malfunction, contact the STERIS technical department. Any modification or repair to this device by personnel
notapproved by STERIS is prohibited.
Y
10. QUICK TROUBLESHOOTING GUIDE
11. ENVIRONMENTAL PROTECTION
Product recycling: this equipment should be disposed of with a licensed electrical and electronic component recycling authority.
12. MAINTENANCE SCHEDULE
12.1 PREVENTIVE MAINTENANCE
To retain the initial performances and reliability of your surgical light, maintenance
and inspection operations should be performed once a year as follows:
- During the warranty period, by a STERIS technician or a STERIS-approved agent,
- Outside the warranty period, by a STERIS technician or a STERIS-approved agent, or
the hospital technical department.
Before any maintenance, check that the light has been switched off and has cooled
down
12.2 LEVEL ONE MAINTENANCE
a) Daily inspection:
- Check that the sterilizable handle clicks into place and locks correctly.
- Check the position of the arm.
The daily inspection must be performed by qualified personnel, approved by the body
in charge of maintenance operations in the surgical facility.
b) Backup battery (if this option is applicable)
- Check that the light works in backup mode, in the event of a mains power outage.
Daily maintenance must be performed by qualified personnel, approved by the
body in charge of maintenance operations in the surgical facility.
c) Annual inspection (should be carried out by an approved technician):
- Check that the stops are present on the flat screen mount arms and on the lights.
c.1- Safety points
Check the following points:
-
Proper tightening of the securing screws on the suspension tube and position of the seals.
- Assembly of the arm(s).
- Additional light attachment stop segments, light disassembly and sleeve lubrication.
- Attachment of all caps and plugs.
- Presence of stop segments and check the wear of stop segment.
- Condition and tightness of brakes.
- Proper operation of the stops
c.2 - Other inspections
- Nominal lighting: see technical data.
- Suspension tube verticality.
- Balancing system setting.
- Sterilizable handle locking mechanism.
- Visual inspection inside and outside the surgical lighting system (connexion of
wiring harnesses, state of painted parts, general appearance and cleanliness of the
undercover, etc.)
- Control of the proper operation of the battery. (Any battery change shall be carried out
only by STERIS technicians or approved technicians)
- Control of the commands (keypad and wall-mounted touch screen, if any) proper
operation of the button, of the touch screen, etc
For this type of procedure, contact the STERIS-approved after-sales support
department. The circuit diagrams, component lists, technical descriptions or any
other useful information for the personnel assigned to install the XLED light are
available from STERIS on request.
Surgical lighting systems - XLED
[20]
Guidance and manufacturer’s declaration - Electromagnetic emissions
List of the cables & accessories in conformity with the
emissions and immunity testing
The surgical lighting XLED
®
is intended for use in an electromagnetic environment specified below. The customer or the user of XLED
®
surgical lighting should assure that it is used
in such environement.
-Power supply units XRP200/XRP100 and its associated cables
-Backup unit XBS200/XBS100 and its associated cables
-Wall mounted XCC003 and its associated cables
-Camera LHD0002 / LMH0010 and its associated cables
-Monitor VTS-24-HD0003
Or :
-Power supply unit XCP000
Emission test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Groupe 1
The XLED
®
surgical lighting uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11 Class A Equipment is suitable for use in all estabishments other than domestic and those directly connected to the public low-voltage power supply network that supplies building
used for domestic purposes.
NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment
(for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting the equipment..
Harmonic emissions IEC 61000-3-2 Not applicable
Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable
13. ELECTROMAGNETIC ENVIRONMENT
Essential performance of XLED® surgical lighting is the delivery of illumination and the limitation of energy to the operating field.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the XLED
®
surgical lighting, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result. Before connecting any equipment, the user should make sure that they respect the applicable regulations and that their connections comply with the manufacturers’ recommendations. XLED
®
surgical lighting needs
special precautions regarding electromagnetic compatibility and needs to be installed and put into service according to EMC information provided in this instruction of use.
The XLED
®
surgical lighting systems is compliant with standard IEC 60601-1-2 : 2014 (Ed.4)
Guidance and manufacturer’s declaration - Electromagnetic immunity
The surgical lighting XLED
®
is intended for use in an electromagnetic environment specified below. The customer or the user of XLED
®
surgical lighting should assure that it is used in such environement.
Immunity test IEC 60601-test level Compliance level Electromagnetic environment guidance
Electrostatic discharge (ESD)
IEC 61000-4-2 ±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Professional healthcare facility environment
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity
should be at least 30 %.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV on mains
±1 kV on inlet / outlet
±2 kV
±1 kV Professional healthcare facility environment
Mains power quality should be that of a typical commercial or hospital environment
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV
±2 kV
Voltage dips, short interruptions and voltage
variations on power supply input lines
IEC 6100-4-11
<5 % UT (>95% dip in UT) for 0,5 cycle
40 % UT(60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
<5 % UT (>95 % dip in UT) for 5 sec
<5 % UT (>95% dip in UT) for 0,5 cycle
40 % UT(60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
<5 % UT (>95 % dip in UT) for 5 sec
Professional healthcare facility environment
Mains power quality should be that of a typical commercial or hospital environment. If the user of XLED
®
surgical
lighting requires continued operation during power mains interruptions, it is recommended that the XLED
®
surgical
lighting be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Professional healthcare facility environment
Power frequency magnetic fields should beat at levels characteristic of a typical location in a typical commercial or
hospital environment.
RF Conducted IEC 61000-4-6 3V
150 kHz to 80MHz
6V in ISM bands between 0,15 MHz and 80 Mkz
0.8 MA at 1 kHz
3V
150 kHz to 80MHz
6V in ISM bands between 0,15 MHz and 80 Mkz
0.8 MA at 1 kHz
Professional healthcare facility environment
RF Radiated IEC 61000-4-3 3V/m
80 Mkz to 2,7 GHz
0.8 MA at 1 kHz
9V/m
710 MHz, 745 MHz
780 MHz, 5240 MHz
5550 MHz, 5785 MHz
27V/m
385 MHz
28V/m
450 MHz, 810 MHz
870 MHz, 930 MHz
1720 MHz, 1845 MHz
1970 MHz, 2450 MHz
3V/m
80 Mkz to 2,7 GHz
0.8 MA at 1 kHz
9V/m
710 MHz, 745 MHz
780 MHz, 5240 MHz
5550 MHz, 5785 MHz
27V/m
385 MHz
28V/m
450 MHz, 810 MHz
870 MHz, 930 MHz
1720 MHz, 1845 MHz
1970 MHz, 2450 MHz
Professional healthcare facility environment
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Steris Xled Surgical Lighting / Xled Surgical Lights Operating instructions

Brand
Steris
Model
Xled Surgical Lighting / Xled Surgical Lights
Type
Operating instructions
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