Surgical

Système lighting systems

d’éclairage chirurgical

User manual
[operation & maintenance] OM202-01EN 2021-06 REVA XLED
 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
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

STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE

STERIS SAS
1. QUALITY REQUIREMENTS 116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE
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: Patient target group

XLED Surgical Lighting System is a medical device intended
®
XLED® Surgical Lighting Systems are not directed to a particular
to illuminate the body of a patient during surgical procedures. patient population: they are supposed to suit any type of patient,
regardless of age, anatomy, gender, etc.
Indication for use
XLED® Surgical Lighting System has no indication for use, Intended user
which means that this medical device is not used to diagnose, XLED® Surgical Lighting System must be used only by qualified
prevent, monitor, treat, alleviate, compensate, replace, modify personnel who are authorized to practice in the healthcare
or control any clinical condition of a patient. facility. This medical device shall be operated in a controlled
environment by a professional familiar with appropriate
Clinical benefit techniques with such equipment.
XLED® Surgical Lighting System does not bring any direct Product developed for surgeons, anesthetists, nurses etc.
positive impact on the health of the patient which would be which are working in operating rooms, pre- anesthesia rooms,
measurable or meaningful. recovery rooms.
By illuminating the body of a patient in a safe and appropriate
manner during a surgical procedure, then XLED® Surgical Essential performance
Lighting System will facilitate the analysis work and the surgical XLED® Surgical Lighting System shall deliver an illumination to
work on the different anatomical regions where the surgery will operating field while limiting the associated energy.
be carried out: this will have a positive impact on management
of the patient by the medical staff during surgery. Intended lifetime
The intended lifetime of XLED® Surgical Lighting System is set
Contraindication – Undesirable side-effect – Residual risks at 10 years, provided that the conditions of use, the cleaning
There is no contraindication, undesirable side-effect or residual and maintenance instructions listed in this user manual are
risks associated with the use of XLED® Surgical Lighting correctly followed.
System. All safety instructions related to the use of this medical
device are listed in chapter 2. 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

 Surgical lighting systems - XLED
2. SAFETY INSTRUCTIONS
! Warning: This device cannot be modified without the manufacturer’s authorisation. 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
! Any serious incident that occurs in relation to this medical device or approved technicians.
should be reported to STERIS and the competent authority of the
member state in which the user and/or patient is established. ! Dismantling some sub-assemblies may impact operation and safety. For example:
- In the case of a procedure on the electrical power supply,
Operation - In the case of a procedure on the suspension arms and the balancing system
! Light is an energy that can potentially dry out tissue dryness. The user should adapt the ! Observe the maintenance schedules set out by STERIS and described in this document.
lighting level to the needs of the procedure carried out, particularly in the case of the use of a
combination of multiple projectors.
! Never try to adjust the suspension yourself.
! In case of combination of multiple projectors, the utraviolet radiation can exceed the autorized ! During maintenance and repair, only original parts must be used.
levels. The user should adapt the quantity of projectors used to the needs of procedure carried
out. ! No interventions may be undertaken on XLED® surgical lighting system before all electrical
power is switched off and the supplies made safe.
! 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 ! No part of XLED® surgical lighting system shall be serviced or maintained while in use with a
eyes. The eyes of the patients must therefore be closed or protected during procedures. patient.

! During the procedure, only the surgical team may touch the sterilizable handle, in order to
ensure sterility. Cleaning / disinfection / Sterilization
! Do not use the light suspension to carry or lift objects. Do not hang from the light. ! Check that power to the XLED® surgical light is OFF before cleaning
! Do not use the wall-mounted power supply units for storage. ! Do not attempt to clean the lighthead unless lighthead has cooled sufficiently.
! XLED® lights are not intended for up-lighting. Do not tilt the lights upside down. ! 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 press the touch screens and the keypad with too much force using unsuitable objects.
! Do not use any products based on chlorine or its derivatives, because this might cause
! In some configurations, due to the presence of several hinges on the suspensions, there is a excessive corrosion.
risk of fingers being caught. Avoid placing hands near the hinges and move the extension arms
with caution. ! Do not dismantle the suspension components (spring arms, lighthead yoke) during cleaning
procedures. Only qualified STERIS maintenance personnel are authorised to dismantle these
! Avoid handling the suspensions roughly, particularly excessive shocks against the stops. The components.
stops are only end of travel components. Take care of the risks of collisions with surrounded
equipments when moving the extension arms. ! To ensure satisfactory Sterilization, take care not to allow any dirt to penetrate inside the
handle.
! 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 ! After each Sterilization and before each additional use of the sterilizable handle:
it from rolling, dropping and breaking. Also, to avoid scratching the lens surface, do not stand
camera up with lens side facing down. - Check that there is no cracking and that the latch works.
! Do not bump the lighthead into walls or other equipment. Always use handles when positioning - Replace the handle if it shows crack or deformation.
®
the lighthead during surgical procedures, or when cleaning or servicing the XLED surgical
lighting systems. - Refit the handle in the light and lock by turning (click).
Installation ! Sterilizable handles should be disposed of in a similar manner to that of other hazardous
hospital waste.
! Installation and integration operations should only be assigned to STERIS technicians or
qualified technicians and should be carried out according to the installation instructions ! After application of disposable sterile handle, inspect it for barrier integrity; in order to detect
prepared by STERIS.. any split or any tear that can lead to a breach in the sterility barre
To view the technical description of XLED® lights, contact the STERIS-approved after-sales
support department.
Environmental conditions
! 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 • Transport / storage: temperature 0°C-65°C, humidity 10-85% non-condensing, pressure
surgical lights, in order to create a surgical lighting system. This combination is fail safe, as 500 to 1060hPa, do not store outside
a minimum illuminance will be always provided to the operating area in case of single fault
condition of surgical light. • Operation: temperature 10°C-40°C, humidity 10-75%, pressure 800 to 1060hPa.

! The lighting systems should not be installed in areas subject to an explosive risk (presence of ! XLED® surgical system is not intented for outdoor use, and shall not be exposed to high
flammable anaesthetic gases). humidity for extented periods.

! XLED® surgical lighting system may not be used in the vicinity of strong magnetic fields (MRI
environment) Electrical safety
! XLED® surgical lights are not intented to operate in an oxygen rich-environment. ! 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
! To prevent any risk of electric shock, this appliance should only be connected to an earthed 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
power supply system.
from the backup unit.
! 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 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
! The manufacturer warranty is subject to the use of the recommended power supplies. 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.
! 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.

[5]
 Surgical lighting systems - XLED
3. SYMBOLS USED
Local light control (keypad)

Light On/Off Light intensity indication

keypad
XLED

Increase light intensity Decrease light intensity

Activate/Deactivate ambient lighting Backup power operation indicator

Camera On/Off Activate auto focus / brightness

camera keypad

580001046 indice 02
XLED

Set zoom Rotate camera

color temp
XLED

Select color temperature color temperature indication (if ordered)

5000K

CMJN 0,73,94,0
4500K

4000K
3500K
CMJN 0,28,93,0

CMJN 49,0,1,0

Wall-mounted control (touch screen) icons

CMJN 66,30,0,0

PANTONE 2728C

Select camera
RAL7035 menu Select lighting menu
Navigation / Settings

RAL 7036

RAL9010 Indication of level of selected camera function (zoom, bright-

Select maintenance menu
coupole couleur température caméra ness, focus) / lighting (intensity)
Artwork for the labelling for the XLED LIGHT

Increase level of selected function Decrease level of selected function

On/Off

Activate/Deactivate ambient lighting Identification of light(s) (1,2 or 3) on suspension

Lights

3500K 4000K
1 2 Set of color temperature (if ordered)
4500K 5000K 1 2
ZOOM 1 2 1 2
ALL
AUTO ZOOM
ZOOM Set zoom ZOOM ALL
AUTO
ALL
Freeze image
ROTATE SAVE SAVE ALL
1 2 AUTO AUTO
ROTATE SAVE SAVE
1 2
LOAD
1
LOAD
2 ROTATE
SAVE
1
Memory
SAVE
2
reminder buttons (LOAD1, LOAD2, etc.)
1 2 ROTATE SAVE
1
SAVE
2
Save to memory buttons (SAVE1, SAVE2, etc.)
1LOAD
12 2
LOAD
LOAD LOAD LOAD LOAD
1 2
Camera

1 2
1 2 Set light intensityBRIGHT BRIGHTFOCUS
WB
FOCUS Set focus / autofocus
WB AUTO AUTO1 WB 2 AUTO
Set
BRIGHT FOCUS
AUTO AUTO
Set AUTO
WB WB Gamma

1 AUTO
2 AUTO
Set
WB
AUTO Set white balance (automatic/manual) ZOOM
1 2 ALL
Set Gamma (pre-setting 1/ pre-setting 2)
Gamma AUTO
Gamma
ZOOM
ZOOM ROTATE SAVE SAVE
ALL
1 2
ALL
AUTO Pre-configuration AUTO
LOAD LOAD
Rotate camera
ROTATE SAVE 1
SAVE 2
SAVE SAVE 1 2
ROTATE
1 2 LOAD LOAD

LOAD LOAD Mains operation 1 2

Backup battery-powered operation
1 2
MODES

Touch screen active External light control active (RS232)

Local light control active

[6]
 Surgical lighting systems - XLED
Identification labels
Caution: consult accompanying documents Direct current REF Product reference

Date of manufacture Protective earth ground SN Serial number

(YYYY-MM-DD)

WEEE Directive: the product must be recycled Hazardous voltage Alternating current

Compliance with essential requirements of

Name and address of manufacturer Caution
European legislation
65°C

This way up 0°C

Temperature limit MD Medical device

1060

Fragile, handle with care Atmosphere pressure limitation

500

85

Handle with care Humidity limitation

10

[7]
Surgical lighting systems - XLED
4. OVERVIEW
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.

Fixed color temperature

Common range characteristics Single cardanic Dual cardanic
XLDV1SS
XLED® SINGLE SPOT

Span 490 mm
Number of LEDs 20
Power consumption 25W

XLDV2SF XLDV2SC XLDV2DF XLDV2DC

XLED® 2 SPOTS

Span 665 mm Span 665 mm

Number of LEDs 40 Number of LEDs 40
Power consumption 50W (+5W with camera) Power consumption 50W (+5W with camera)

XLDV3SW XLDV3SC XLDV3DW XLDV3DC

Technology White LEDs

Ambient lighting ≈100 Lx
Power supply 24V 
XLED® 3 SPOTS

Span 695 mm Span 695 mm

Number of LEDs 60 Number of LEDs 60
Power consumption 70W (+5W with camera) Power consumption 70W (+5W with camera)

XLDV4SW XLDV4DW
XLED® 4 SPOTS

Span 785 mm Span 785 mm

Number of LEDs 80 Number of LEDs 80
Power consumption 85W Power consumption 85W

[8]
 Surgical lighting systems - XLED
Variable color temperature
Common range characteristics Single cardanic Dual cardanic
XLDV1SST
XLED® SINGLE SPOT

Span 490 mm
Number of LEDs 20
Power consumption 20 W

XLDV2SFT XLDV2SCT XLDV2DFT XLDV2DCT

XLED® 2 SPOTS

Span 665 mm Span 665 mm

Number of LEDs 40 Number of LEDs 40
Power consumption 30 W (+5W with camera) Power consumption 30 W (+5W with camera)

XLDV3SWT XLDV3SCT XLDV3DWT XLDV3DCT

Technology White LEDs
2 warm LEDs, 2 cold LEDs

Ambient lighting ≈100 Lx

24V 
XLED® 3 SPOTS

Power supply

Span 695 mm Span 695 mm

Number of LEDs 60 Number of LEDs 60
Power consumption 55 W (+5W with camera) Power consumption 55 W (+5W with camera)

XLDV4SWT XLDV4DWT
XLED® 4 SPOTS

Span 785 mm Span 785 mm

Number of LEDs 80 Number of LEDs 80
Power consumption 60 W Power consumption 60 W

[9]
Surgical lighting systems - XLED

5. CHARACTERISTICS
Electrical characteristics: (for XLED® surgical lights installed with XRP or XWP power supply)
Mains 100-120/220-240 VAC 50/60 Hz Standalone Min. 1h30
500 VA max (power supply unit) - 150 VA (backup unit) operation
Protection Class I Charge/discharge Indicators on backup unit
indicator
Fuse Mains: 1xT6.3A, 250V, 6.3x32 BC1500A
F1, F2: F16A, 6.3x32, 500V BC1500A (rectifier board) Operation continuous
(power supply F3, F4: F8A, 5x20, 250V BC1500A (rectifier board)
unit) F5: T0.5A, 5x20, 250V BC1500A (rectifier board) Liquid tightness IP63 (only for lighthead positioned in normal condition of use)
F6: F0.5A, 5x20, 250V BC1500A (rectifier board)
F1: FF10A, 6.3x32, 500V BC10 kA (switch board)
Fuse 1xF16A, 230V, 10.3x25.8 BC 6kA (external)
1xF4A, 5x20, 250V BC1500A (charger board)
(backup unit)
Batteries 2x12V 24Ah Sealed lead

Optical characteristics for fixed color temperature lightheads:

Characteristics (measured when the light is cold) Unit 1 spot 2 spots 3 spots 4 spots
Small Fixed Pattern Wavelens (lens in phase)
pattern
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%

[10]
 Surgical lighting systems - XLED
Optical characteristics for variable color temperature lightheads:
Characteristics (measured when the light is cold) Unit 1 spot 2 spots 3 spots 4 spots
Small Fixed Pattern Wavelens (lens in phase)
pattern
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

[11]
Surgical lighting systems - XLED
6. INSTALLING THE STERILIZABLE HANDLE
NON-CAMERA-READY LIGHTHEADS

(2)
a) Installing / removing the sterilizable “Clic”
handle
(1) (1)
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
(2)
To remove the sterilizable handle (1) from the (3)
light, keep the push-button (3) pressed down
while pulling the handle downwards, to remove it (1)
from its mount (2).
(1)

b) Installing a STERIS disposable handle a b

“Clic”
1) Insert the STERIS adapter (reference XADSTE)
(4) onto the light until you hear a “click”
indicating that it is securely in place.
(4)

2) Screw the STERIS handle (reference LB20)

completely onto the adapter.
c d
3 - 4) Insert the disposable sterile handle onto
the STERIS light handle (reference LB53).

X2
c) Installing a DEVON disposable handle X2

1) Insert the DEVON handle (reference “Clic”

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.

[12]
 Surgical lighting systems - XLED
CAMERA-READY LIGHTHEADS

t cam a) Installing a STERIS sterilizable handle

1) Insert the STERIS adapter (supplied with the light) onto the light.
Montage poignée stérilisable
2) Screw the STERIS adapter completely.
sur adaptateur
3) Insert the sterilizable handle (supplied with the light) onto1/2
Montage poignée stérilisable
suruntil
the adapter adaptateur
you hear a “click”2/2
indicating that it is securely in place.

a b c

“Clic”

b) Installing the camera (reference LMH0010X not supplied with the light)

t STERIS (b)
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.

Montage poignée STERIS sur

a b c
(a)

adaptateur 1/3
(a)

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 Montage poignée
screw it onto the STERIS
adapter to secureMontage sur poignée STERIS
it in place. sur
4) Insert the STERIS disposable sterile handle (reference LB53).
(d) 4) Insert the disposable sterileadaptateur
handle. 1/3 adaptateur 2/3
a b c

Montage poignée STERIS sur

(c) (e) adaptateur 3/3
(c)
d

c.2) Installing a DEVON handle

Montage poignée
1) Insert the DEVON
Montage
handle (reference 50001200)surontopoignée DEVON
Montage
the light by aligning surpinpoignée
the handle DEVON
with that of theMontage
recess. surpoignée DEVON sur
2) Screw the handle completely.
adaptateur 1/4
3 and 4) Insert the disposableadaptateur 2/4LT-F01B).adaptateur 3/4
sterile handle (reference adaptateur 4/4
a b c d

[13]
 5
115,41
351,12

280,95
Surgical lighting systems - XLED

R=
9,4
132,70

9
27,82

1) Wall-mounted unit:

25,81
7. OPERATION
a) Use of wall-mounted light control On/Off
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). Touch screen
The light control is activated by pressing the touch screen: if the screen lights up, this indicates that 2) Remote power supply in service
the power supply is in normal operating mode. room + Wall-mounted touch panel in
theatre
When you press , the light in question lights up progressively until it stabilises at the last value Service room
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 Op. theatre
current lighting level .
It is possible to switch to ambient lighting mode by pressing ; to return to surgical lighting mode,
simply press again. Touch screen

General light operation Lighting menu Navigation

Power Mains Lighting
supply
Batteries
Light settings
Control GUI
active
On/Off
Light keypad
Number and position
RS232 of active lights:
1 lowest
Operating fault 2 middle
3 highest
Camera connection
Double light version (for a triple
2 cameras, 3 coupoles sans camera 1 coupole
configuration)
Ambient light on/off

Version with Version with

single light triple light
+camera

b) If adjustable color temperature

(if ordered)
The color temperature is adjusting using
1 2
for the set of lights.
1 2
3500K 4000K 4500K 5000K

The cursor ambiance

indicates the current
color temperature.
4000K selected sur coupole 1 éclairage sur coupole 1
uniquement, les autres eteintes uniquement
Temperature sur secours 3500K 4000K

adjustment color: 4500K 5000K

3500K 4000K 4500K 5000K 3500K, 4000K,

4500K, 5000K
Double light version + camera + temperature
adjusment color

[14]
 Surgical lighting systems - XLED
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: Navigation
- Pressing automatically switches to backup STERIS
mode for 5 sec and returns to normal mode, service
making it possible to check that the switch Service menu
works properly.
- Pressing switches to backup mode until it Maintenance settings
is pressed again, making it possible to check the 1 2 Backup battery
battery standalone operating time. The system
switch test
must be returned manually to normal mode; the
user should take care to perform this procedure CHECK
Backup battery
at the end of the test, otherwise, the batteries standalone
may be discharged excessively and the lighting operation test
may be switched off even when the mains power
Access to operating
is present.
setting
- During these tests, the indicator light
switches to on the screen, and the yoke
2 cameras, 3 coupoles
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.

d) Use of the camera menu

Camera settings
1 2
2 cameras, 3 1coupoles
Camera menu (page 1/2) sans camera 1 coupole
BRIGHT FOCUS

Automatic setting AUTO

WB
AUTO
Navigation
1 2
1 2
Set
AUTO WB

Brightness BRIGHT
1 2
WB
Gamma
FOCUS
Camera
pages 1&2
1 2
BRIGHT FOCUS
AUTO AUTO WB
Set AUTO
White balance AUTO 1 WB Set
AUTO
2 AUTO
Gamma
ZOOM 1 2
1 2
Automatic/manual WB
ALL
BRIGHT Gamma FOCUS
WB AUTO
Focus
BRIGHT FOCUS

ambiance sur coupole 1

AUTO AUTO
Set AUTO
WB WB
AUTO AUTO
Set AUTO
Gamma WB Gamma
SAVE SAVE
Scroll through Gamma
1 2uniquement, les autres eteintes
3 pre-recorded values
LOAD LOAD
1 2
1/2
3500K 4000K 4500K 5000K

1 2 Camera menu 2 (page 2/2)

Zoom 1 2
ZOOM

Freeze
ZOOM 1 12
ALL

ambiance sur coupole

AUTO
éclairage sur coupole 1
1 12 2
ALL
AUTO SAVE SAVE

uniquement, les autres eteintes uniquement sur secours

ROTATE
1 2
ZOOM 1 2 SAVE
ROTATE SAVE
LOAD LOAD
ZOOM 1 ALL 2 1 2
Auto focus, ZOOM
auto 1
ALLAUTO
AUTO 2 BRIGHT Gamma FOCUS
LOAD LOAD
brightness & zoom out
ROTATE
1
SAVE SAVE
SAVE 1 SAVE 2
2 ALL
AUTO
ROTATE AUTO
11 22 AUTO
ZOOM
Memories LOAD SAVE
ROTATE LOAD
LOAD 1 LOAD 1
SAVE ALL
AUTO
WB
2 2
1 2
ZOOM
LOAD LOADSAVE
ROTATE SAVE AUTO Set
Rotate 1 ALL
1 2 AUTO 2 WB WB
LOAD LOAD
ROTATE SAVE 1
SAVE 2
1 2
LOAD LOAD
1 2
2/2

commande en cours depuis la

coupole 1 seule allumée

[15]
Surgical lighting systems - XLED
e) Use of local light control 4 1
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.
5
3 2 6
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 580001046 indic
head 1 or on light head 2.
4 1 6

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. 5000K

CMJN 0,73,94,0
4500K

4000K
3500K
CMJN 0,28,93,0

CMJN 49,0,1,0
5 2 3 7 8
CMJN 66,30,0,0

PANTONE 2728C

g) Use of the HD Camera Ready option (if ordered) RAL7035

RAL 7036
13 9 7 8 11 4 1 2
The camera is switched on by pressing (13); this is indicated by the indicator light (7).WhenRAL9010
the
camera is switched on, it performs auto-focus, auto-brightness, and the zoom is at the same setting as coupole couleur température caméra
the last time the camera was switched off. Artwork for the labelling for the XLED LIGHT

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. 12 5 6 3
10
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. 580001046 ind

h) Use of the adjustment temperature color option (if ordered) 13 9 5 8 11 2 3 6 1

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.
5000K

4500K
CMJN 0,73,94,0
4000K
3500K
CMJN 0,28,93,0

CMJN 49,0,1,0

CMJN 66,30,0,0 10 7 12 14 15 4

PANTONE 2728C

RAL7035

RAL 7036

RAL9010

coupole couleur température caméra

[16] Artwork for the labelling for the XLED LIGHT
 Surgical lighting systems - XLED
i) Positioning the light
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.

j) Adjusting the light

XLED®1 spot single cardanic lighthead XLED®4 spot dual cardanic lighthead
e.g. XLDV1SS e.g. XLDV4DW
>360°
+45°
>360° a a
+30°

>360°

>360° >360°
>360° -50°

310° c
-45°

c
310°
320°

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.

Handle blocked to the right, Handle blocked to the left,

Wavelens OFF, the spot size is Wavelens ON, the spot size is
set to minimum. set to maximum.

Note: the Wavelens function

is maintained on the 3 spot
lightheads when the camera is in
position.

l) Switching on ambient lighting

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.

[17]
Surgical lighting systems - XLED
8. CLEANING / DISINFECTION / STERILIZATION
The user should contact the sanitary specialists of the facility to ensure
compliance with national hygiene and disinfection requirements 8.2.4 DRYING
(standards and directives). The recommended products and procedures - Wipe the handle using a lint-free clean cloth.
should be applied. If in doubt regarding of the compatibility of the active - Before use, the handles should undergo steam Sterilization.
substances to be used, contact the local STERIS after-sales support 8.2.5 STERILIZATION
department. The previously cleaned handles should undergo steam Sterilization,
according to the following instructions and cycles:
8.1 CLEANING AND DISINFECTING THE LIGHT:
Before any cleaning, check that the light has been switched off and Country Sterilization cycle Temperature Time
has cooled down. [min]
Wear the recommended personal protective equipment (gloves,
goggles).
USA & Gravity 250°F 30
General cleaning, disinfection and safety instructions: Canada 121°C
- Remove the sterilizable handles.
- Clean the lighting system and the suspension using a surface USA & Pre-vacuum 270°F 4
detergent and follow the manufacturer’s dilution and temperature Canada 132°C
recommendations.
- Rinse using a well-wrung cloth, wipe and leave to dry. USA & Pre-vacuum 275°F 3
- Apply a disinfectant evenly, according to the manufacturer’s Canada 135°C
recommendations.
- Leave to dry. France ATNC (Prion) (Pre-vacuum) 134°C 18
- Rinse using a moistened cloth, to remove any residual product. Other Pre-vacuum Comply with national
Cleaning the lighting surface countries regulations
- Check that the light has been switched off and has cooled down
sufficiently.
- Wear rubber gloves. - Ensure that each handle is clean before continuing the process.
- Prepare a disinfectant or cleaning solution intended for plastic materials - Wrap the handles in Sterilization wrap (double wrap or equivalent).
(PC/PMMA). - The handles can also be packed in paper/plastic Sterilization bags, for
- NEVER SPRAY ANYTHING directly onto the light. Moisten a soft cloth using easier identification and reuse.,
cleaning solution and squeeze out the excess moisture. - Place the handles, with the opening facing down, on the sterilizer trays.
- Scrub the surfaces to be cleaned thoroughly. - Attach the biological and/or chemical indicators for monitoring the
- Rinse all the surfaces using a well-wrung clean soft cloth and clear water. Sterilization process, according to current regulations.
- Wipe all the surfaces with clean and dry soft cloth. - Start the Sterilization cycle, according to the sterilizer manufacturer’s
- Make sure that the sterilizable plastic handle (if used) is sterilized using a instructions.
standard hospital cycle.
This sterilizable plastic handle has a limited lifetime expectancy because
Cleaning the touch screens of the sterilization cycles it will undergo.
- Switch off the wall-mounted unit or the touch screen.
- Wipe it using a compress (or non-woven equivalent) soaked in a As a consequence, after each sterilization and before each additional
detergent - disinfectant solution, and well wrung. use of the sterilizable handle:
- Allow to dry. - Check that there is no cracking and that the latch works.
- Replace the handle if it shows crack or deformation.
Examples of recommended products - Refit the handle in the light and lock by turning (click)
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 8.3 CLEANING THE CAMERA MODULE
because the compatibility and the effectiveness of the chemicals have The compact camera is protected in an aluminium housing with urethane
not been demonstrated. moulding. A glass lens produces a clear video image while preventing
dust or fluids from entering.
Products which are not recommended The HD camera module contains sensitive electronic components liable
Glutaraldehyde, phenol, Iodine, bleach solution, ethanol, Betadine®. 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
8.2 CLEANING AND STERILIZING STERILIZABLE HANDLES using steam or using a liquid. However, the outer surface may be cleaned
8.2.1 PREPARATION BEFORE CLEANING with chemicals recommended by STERIS.
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.

[18]
 Surgical lighting systems - XLED
9. LIST OF RECOMMENDED SPARE PARTS
REFERENCES DESCRIPTIONS REFERENCES DESCRIPTIONS
XHAND5 Kit of 5 XLED sterilizable handles
®
LT-F01B Pack of 100 DEVON disposable sterile handles
XADSTE STERIS Harmony disposable sterile handle mount adapter LMH0010X STERIS HD camera handle
LB20 STERIS Harmony disposable sterile handle mount for non LB54 Pack of 30 STERIS HD camera disposable sterile handles
camera ready lightheads 50001200 DEVON disposable sterile handle mount for camera-ready
LB53 4 packs of 30 STERIS Harmony disposable sterile handles lightheads
31146619 DEVON disposable sterile handle mount non camera ready P136820088 LB20 disposable sterile handle mount for camera-ready
lightheads lightheads

10. QUICK TROUBLESHOOTING GUIDE

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 - Sterilization setting overshoot (temperature, - Check that the locking mechanism (audible click) and the handle
the mount correctly time) assembly are working
- The maximum service life has been exceeded/ - Replace the handle
the handle is deformed
Light deviation - Suspension tube verticality defect - Check the verticality and ceiling structure
- Unstable ceiling structure - Call the STERIS servicing department
- The brakes are not fastened tightly enough - Adjust the locks
Light too flexible or too hard to handle - Incorrect brake setting - Adjust the balancing system
- Lack of lubrication - Call the STERIS servicing department
The video camera system is not responding to - Incorrect wiring - Check the connection of the HD video cable
controls on the wall-mounted lighting unit - Faulty wiring - Call the STERIS servicing department
Poor-quality video image - Incorrect settings - Restore the default camera settings
- Poor connection - Check the connectors at the rear of the wall-mounted unit
- Check that the signal source is functioning

Y 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.

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 - Assembly of the arm(s).
To retain the initial performances and reliability of your surgical light, maintenance - Additional light attachment stop segments, light disassembly and sleeve lubrication.
and inspection operations should be performed once a year as follows: - Attachment of all caps and plugs.
- During the warranty period, by a STERIS technician or a STERIS-approved agent, - Presence of stop segments and check the wear of stop segment.
- Outside the warranty period, by a STERIS technician or a STERIS-approved agent, or - Condition and tightness of brakes.
the hospital technical department. - Proper operation of the stops
Before any maintenance, check that the light has been switched off and has cooled
down c.2 - Other inspections
- Nominal lighting: see technical data.
12.2 LEVEL ONE MAINTENANCE - Suspension tube verticality.
a) Daily inspection: - Balancing system setting.
- Check that the sterilizable handle clicks into place and locks correctly. - Sterilizable handle locking mechanism.
- Check the position of the arm. - Visual inspection inside and outside the surgical lighting system (connexion of
The daily inspection must be performed by qualified personnel, approved by the body wiring harnesses, state of painted parts, general appearance and cleanliness of the
in charge of maintenance operations in the surgical facility. undercover, etc.)
- Control of the proper operation of the battery. (Any battery change shall be carried out
b) Backup battery (if this option is applicable) only by STERIS technicians or approved technicians)
- Check that the light works in backup mode, in the event of a mains power outage. - Control of the commands (keypad and wall-mounted touch screen, if any) proper
Daily maintenance must be performed by qualified personnel, approved by the operation of the button, of the touch screen, etc
body in charge of maintenance operations in the surgical facility.
For this type of procedure, contact the STERIS-approved after-sales support
c) Annual inspection (should be carried out by an approved technician): department. The circuit diagrams, component lists, technical descriptions or any
- Check that the stops are present on the flat screen mount arms and on the lights. other useful information for the personnel assigned to install the XLED light are
available from STERIS on request.
c.1- Safety points
Check the following points:
- Proper tightening of the securing screws on the suspension tube and position of the seals.

[19]
Surgical lighting systems - XLED
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 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 -Power supply units XRP200/XRP100 and its associated cables
in such environement. -Backup unit XBS200/XBS100 and its associated cables
-Wall mounted XCC003 and its associated cables
Emission test Compliance Electromagnetic environment – guidance -Camera LHD0002 / LMH0010 and its associated cables
-Monitor VTS-24-HD0003
The XLED® surgical lighting uses RF energy only for its internal function. Or :
RF emissions CISPR 11 Groupe 1 Therefore, its RF emissions are very low and are not likely to cause any -Power supply unit XCP000
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.
Harmonic emissions IEC 61000-3-2 Not applicable 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
Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable take mitigation measures, such as relocating or re-orienting the equipment..

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) Professional healthcare facility environment
IEC 61000-4-2 ±8 kV contact ±8 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity
±15 kV air ±15 kV air should be at least 30 %.

Electrical fast transient/burst ±2 kV on mains ±2 kV

IEC 61000-4-4 ±1 kV on inlet / outlet ±1 kV
Professional healthcare facility environment
Mains power quality should be that of a typical commercial or hospital environment
Surge ±1 kV line(s) to line(s) ±1 kV
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV

Voltage dips, short interruptions and voltage <5 % UT (>95% dip in UT) for 0,5 cycle <5 % UT (>95% dip in UT) for 0,5 cycle
variations on power supply input lines
40 % UT(60 % dip in UT) for 5 cycles Professional healthcare facility environment
40 % UT(60 % dip in UT) for 5 cycles
IEC 6100-4-11 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
70 % UT (30 % dip in UT) for 25 cycles 70 % UT (30 % dip in UT) for 25 cycles lighting be powered from an uninterruptible power supply or a battery.
<5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 5 sec

Power frequency (50/60 Hz) Professional healthcare facility environment

magnetic field 30 A/m 30 A/m Power frequency magnetic fields should beat at levels characteristic of a typical location in a typical commercial or
IEC 61000-4-8 hospital environment.

RF Conducted IEC 61000-4-6 3V 3V Professional healthcare facility environment

150 kHz to 80MHz 150 kHz to 80MHz
6V in ISM bands between 0,15 MHz and 80 Mkz 6V in ISM bands between 0,15 MHz and 80 Mkz
0.8 MA at 1 kHz 0.8 MA at 1 kHz

RF Radiated IEC 61000-4-3 3V/m 3V/m Professional healthcare facility environment

80 Mkz to 2,7 GHz 80 Mkz to 2,7 GHz
0.8 MA at 1 kHz 0.8 MA at 1 kHz

9V/m 9V/m
710 MHz, 745 MHz 710 MHz, 745 MHz
780 MHz, 5240 MHz 780 MHz, 5240 MHz
5550 MHz, 5785 MHz 5550 MHz, 5785 MHz

27V/m 27V/m
385 MHz 385 MHz

28V/m 28V/m
450 MHz, 810 MHz 450 MHz, 810 MHz
870 MHz, 930 MHz 870 MHz, 930 MHz
1720 MHz, 1845 MHz 1720 MHz, 1845 MHz
1970 MHz, 2450 MHz 1970 MHz, 2450 MHz

[20]
[21]
Surgical lighting systems - XLED
Surgical lighting systems - XLED

STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE

STERIS SAS
116 Avenue de MAGUDAS
33185 LE HAILLAN - FRANCE

OM202-01EN 2021-06 REVA XLED