4725751

Mobile
Ce plan est la propriété de Stéris Surgical Technologies - 33185 LE HAILLAN - FRANCE et ne peut être communiqué ni reproduit sans notre autorisation
Ceci est un plan C.A.O. il ne peut en aucun cas être modifié manuellement
Ind Modifications N° Date Nom Appr

Casser les angles R= . x Chanfrein de . à 45° x Façonnage Ra . x Pièce ébavurée
Dessiné le: DECOR / TRAITEMENT ETS TOLERANCES GENERALES
Dessiné par:
M. BESNARD
NOTE DE CALCUL MATIERE
Approuvé par: .
J.M. L'HEGARAT
Echelle: 1:5 MASSE
g HOMOLOGATION
.
N° ETUDE: 1/4
. 01 Ind Modifications N° Date Nom Appr Ind Modifications N° D

Casser les angles R= . x Chanfrein de . à 45° x Façonnage Ra . x Pièce ébavurée Casser les angles R= . x Chanfrein de . à 45° x Façonnage Ra .
Dessiné le: DECOR / TRAITEMENT ETS TOLERANCES GENERALES Dessiné le: DECOR / TRAITEMENT ETS TOLERANCES GEN
Dessiné par: Dessiné par:

M. BESNARD M. BESNARD
NOTE DE CALCUL MATIERE NOTE DE CALCUL MATIERE
Approuvé par: . Approuvé par: .
J.M. L'HEGARAT J.M. L'HEGARAT
Echelle: 1:5 MASSE Echelle: 1:5 MASSE
g HOMOLOGATION g HOMOLOG
. .
N° ETUDE: 1/4 N° ETUDE:

. 01 .
User manual
[operation & maintenance]
OM202-01EN 2021-09 REVA XLED Mobile
TABLE OF CONTENTS
1. QUALITY REQUIREMENTS.............................................................................................................................................................. 3
2. SAFETY INSTRUCTIONS................................................................................................................................................................. 4
3. SYMBOLS USED............................................................................................................................................................................. 5
4. OVERVIEW..................................................................................................................................................................................... 6
5. CHARACTERISTICS........................................................................................................................................................................ 7
6. INSTALLATION INSTRUCTIONS..................................................................................................................................................... 8
7. INSTALLING THE STERILISABLE HANDLE................................................................................................................................... 11
8. OPERATING INSTRUCTIONS........................................................................................................................................................ 11
9. CLEANING / DISINFECTION / STERILIZATION............................................................................................................................. 14
10. LIST OF RECOMMENDED SPARE PARTS................................................................................................................................... 15
11. QUICK TROUBLESHOOTING GUIDE............................................................................................................................................ 15
12. ENVIRONMENTAL PROTECTION ............................................................................................................................................... 15
13. MAINTENANCE SCHEDULE........................................................................................................................................................ 15
14 - ELECTROMAGNETIC ENVIRONMENT........................................................................................................................................ 16
Mobile Demo Unit - XLED®
Dear Customers,
STERIS would like to thank you for choosing the XLED® Mobile, 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
1. QUALITY REQUIREMENTS STERIS SAS

STERIS quality system has been awarded the following certifications
• ISO 13485*
for the design, manufacture, sale and installation of surgical tables, platforms, transfer trolleys and their extensions and accessories,
lighting systems, pendants, washers and disinfectors, as well as for after-sales support.
The XLED® Mobile 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® Mobile is a medical device intended to illuminate XLED® Mobiles are not directed to a particular patient
the body of a patient during surgical procedures. population: they are supposed to suit any type of patient,
regardless of age, anatomy, gender, etc.
Indication for use
XLED® Mobile has no indication for use, which means Intended user
that this medical device is not used to diagnose, prevent, XLED® Mobile must be used only by qualified personnel
monitor, treat, alleviate, compensate, replace, modify or who are authorized to practice in the healthcare facility. This
control any clinical condition of a patient. medical device shall be operated in a controlled environment
by a professional familiar with appropriate techniques with
Clinical benefit such equipment.
XLED® Mobile does not bring any direct positive impact on Product developed for surgeons, anesthetists, nurses etc.
the health of the patient which would be measurable or which are working in operating rooms, pre- anesthesia
meaningful. rooms, recovery rooms.
By illuminating the body of a patient in a safe and appropriate
manner during a surgical procedure, then XLED® Mobile Essential performance
will facilitate the analysis work and the surgical work on XLED® Mobile shall deliver an illumination to operating field
the different anatomical regions where the surgery will be while limiting the associated energy.
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® Mobile is set at 10 years,
Contraindication – Undesirable side-effect – Residual risks provided that the conditions of use, the cleaning and
There is no contraindication, undesirable side-effect or maintenance instructions listed in this user manual are
residual risks associated with the use of XLED® Mobile. All correctly followed.
safety instructions related to the use of this medical device
are listed in chapter 2. Placing on the market
The XLED® Mobile was launched on the market in 2016.
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® Mobile 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
[3]
2. SAFETY INSTRUCTIONS
Y 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.
Pinch points Maintenance

! During product positioning, moving different sections of the mobile stand ! The safety, reliability and proper operation of the lighting system can
can cause pinch points to appear which can injure the surgical team. only be ascertained and guaranteed by STERIS. Repairs or adjustments
Users must therefore be aware of the risks and pay particular attention to should only be assigned to STERIS technicians or approved technicians.
the following zones
! Dismantling some sub-assemblies may impact operation and safety.
! 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® Mobile before all
electrical power is switched off
! No part of XLED® Mobile shall be serviced or maintained while in use
with a patient.
Cleaning / disinfection / sterilisation
! After each sterilization and before each additional use of the sterilizable
handle:
Operation - Check that there is no cracking and that the latch works
! Light is an energy that can potentially dry out tissue dryness. The user - Replace the handle if it shows crack or deformation
should adapt the lighting level to the needs of the procedure carried out. - Refit the handle in the light and lock by turning (click)
! Do not look directly at the light source, given its high intensity and the ! Sterilizable handles should be disposed of in a similar manner to that of
blue light in the LED. other hazardous hospital waste
! Surgical interventions in the face with unprotected, open eyes may
result damages to the eyes. The eyes of the patients must therefore be ! To ensure satisfactory Sterilization, take care not to allow any dirt to
closed or protected during procedures. penetrate inside the handle.
! During the procedure, only the surgical team may touch the sterilisable ! After application of disposable sterile handle, inspect it for barrier
handle, in order to ensure sterility. integrity; in order to detect any split or any tear that can lead to a
! Do not use the light suspension to carry or lift objects. Do not hang from the light. breach in the sterility barrier
! XLED® lights are not intended for up-lighting. Do not tilt the lights ! Check that power to the XLED® Mobile is OFF before cleaning
upside down.
! Do not attempt to clean the light head unless light head has cooled
! Do not press the keypad with too much force or with insuitable object. sufficiently
! Avoid handling the suspension roughly, particularly excessive shocks ! After cleaning procedures on mobile versions, ensure that no residual
against the end of travel stop. Do not bump the lighthead into walls or
other equipment. Always use handles when positioning the lighthead water remains on the mains socket IEC.
during surgical procedures, or when cleaning or servicing the XLED®
Mobile ! Remove all water residue before connecting the power cord to the
mains.
! Power cord shall be handled carefully. Do not pull them up, do not force
! Avoid infiltration of liquids inside the lighthead. This type of infiltration is
their entry in the mains socket IEC.

Dessiné par:
liable to affect or damage the lighting system.

M. BESNARD
Approuvé par: .
J.M. L'HEGARAT
MASSE
! Only power cord provided by STERIS shall be used with XLED® Mobile
Echelle: 1:2 HOMOLOGATION
g
.
N° ETUDE: 5/7
. 01
! When power cord is connected to XLED® Mobile ,and therefore is lying ! To prevent damaging equipment, do not use abrasive pads or cleaners.
on the floor, pay attention to this power cord when moving around Do not spray cleaner or disinfectors directly on equipment
XLED® Mobile . Remove the cable after the procedure.
! Do not use any products based on chlorine or its derivatives, because
Installation this might cause excessive corrosion.
! The lighting systems should not be installed in areas subject to an ! Do not dismantle the suspension components (spring arms, lighthead
explosive risk (presence of flammable anaesthetic gases).
yoke) during cleaning procedures. Only qualified STERIS maintenance
! To prevent any risk of electric shock, this appliance should only be personnel are authorised to dismantle these components.
connected to an earthed power supply system.
! Installation operations of XLED should only be assigned to STERIS
technicians or qualified technicians and should be carried out according
to the installation instructions prepared by STERIS.
! XLED® Mobile may not be used in the vicinity of strong magnetic fields
(MRI environment).
! XLED®® Mobile shall be considered minor surgical light. It means that
XLED Mobile shall mandatory be operated in surgical rooms where a
ceiling mounted surgical light is installed. This combination is fail safe,
as a minimum illuminance will always be provided to the operating area
in case of simple fault condition of surgical light.
[4]
Environmental conditions referred to as standby.
Transport / storage: temperature 0°C-60°C / 32°F-140°F, humidity 10-75%
non-condensing, pressure 500 to 1060hPa ! The user may not touch parts of XLED® Mobile and the patient at
the same time, to avoid complications due to electrostatic discharge
Do not store outside between metallic parts of the device and the patient.
Operation: temperature 10°C-40°C / 50-104°F, humidity 30-75%, pressure
800 to 1060hPa Moving the mobile stand
! When moving the mobile floor stand version apart from surgical
! XLED® Mobile is not intented for outdoor use, and shall not be exposed procedures, retract the mast and secure it with the safety elastic cord in
to high humidity for extented periods. order to improve the stability of the device
! Before moving the equipment, ensure the path is free of obstacles.
Electrical safety Move the mobile base floor stand carefully. Adapt the speed to the
! Warning: To prevent any risk of electric shock, this appliance should environment (corridor width, corner angles, doors, etc...)
only be connected to a grounded power supply system
! Before moving the equipment, ensure that the power cord is
! The mobile floor stand must always be positioned so that the power disconnected
cord with its mains plug can be disconnected easily when connected to
the surgical light ! Before starting any surgical procedures, ensure that the mobile floor
stand is stable. Never step on the mobile base of the XLED Mobile
®
! The power cord with its mains plug is thus the device used to isolate ! Do not place any objects on the mobile base because they could impair
the mobile floor stand version from supply mains the proper operation of the product
! In case of any damage to the power supply cable or plug, do not
connect the equipment to the power apply and immediatly contact Antistatic link
STERIS technician.
! Use the XLED® Mobile on an antistatic floor, or connect it to an
! No BF or CF class application components according to IEC 60601-1 equipotential cable using the socket designed for this.
may be directly connected.
! The OFF position of the local light control (keypad) turns off control to
lightheads, but the XLED surgical system is still energized. This mode is
3. SYMBOLS USED
Local light control (keypad)
580001046 indice 02
Light On/Off Light intensity indication
Increase light intensity Decrease light intensity
Activate/Deactivate ambient lighting Backup power operation indicator

5000K
Select color temperature (only for XLED color temperature)

CMJN 0,73,94,0
4500K color temperature indication (if ordered)
4000K
3500K
CMJN 0,28,93,0
CMJN 49,0,1,0 Identification labels

CMJN 66,30,0,0
Caution: risk of crushing fingers PANTONE 2728C No access for unauthorized persons
RAL7035
Caution: consult accompanying documentsRAL 7036 Name and address of manufacturer

RAL9010
coupole couleur température caméra

Date of manufacture (YYYY-MM-DD) Artwork for the labelling for the XLED LIGHT Do not push
No stepping on surface Alternating current
Direct current Protective earth ground
Equipotentiality plug Maximum weight of mobile demo unit
WEEE Directive: the product must be recycled Compliance with essential requirements of European legislation
SN Serial number REF Product reference

65°C
Caution 0°C Temperature limit

1060
MD Medical device 500

Atmosphere pressure limitation
85
10
Humidity limitation
[5]
4. OVERVIEW
4.1 MOBILE SPECIFICATIONS
This mobile support guarantees a safe and easy use of the XLED® light:
• It is equipped with a telescopic mast (stroke: 1130 mm) which can be easily deployed with the hand pump and allows a comfortable clearance
height under the light. Each element of the mast must be blocked with a lockable handle to guarantee a good stability.
• It is equipped with a counterweight to allow a comfortable clearance length between the mobile support and the operating area.
• The light head is easy to move and can be moved around the vertical axis (pivoting range of 40° (+/-20°)).
• It has a movable support with lockable castors.
• A power supply is integrated in the mobile support. The unit must be connected to mains to work.
• It is delivered with an elastic cord to maintain the XLED® light in the low position during transport.
• If it is delivered with the spring arm and XLED® light head already mounted, no tool is required to use the system.
Fixed color temperature
XLDV1SS XLDV3SW
XLED® SINGLE SPOT
Span 490 mm XLED® 3 SPOTS

Span 695 mm
Number of LEDs 20 Number of LEDs 60
Power consumption 25W Power consumption 70W (+5W with camera)
XLDV2SF XLDV4SW
XLED® 2 SPOTS
XLED® 4 SPOTS
Span 665 mm Span 785 mm

Power consumption 50W (+5W with camera) Power consumption 85W
Variable color temperature
XLDV1SST XLDV3SWT
XLED® SINGLE SPOT
XLED® 3 SPOTS

Power consumption 20 W Power consumption 55 W (+5W with camera)
XLDV2SFT XLDV4SWT
XLED® 2 SPOTS
XLED® 4 SPOTS

Power consumption 55 W (+5W with camera) Power consumption 60 W
[6]
5. CHARACTERISTICS
Electrical characteristics:
Mains 100-240 VAC 50-60 Hz
1 phase max 288 VA
Output 24 V 4,16 A
Protection Class 1
Equipotential Din 4280 cord not supplied
Operation continuous
Liquid tightness IP63 (only for lighthead positioned in normal condition of use)
Mechanical characteristics:
XLED® Mobile weight: 166kg max.
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
pattern 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 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

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
R9 Red rendering index (+/-6%)** 3500K 91
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 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
[7]
6. INSTALLATION INSTRUCTIONS
Installation of XLED® Mobile and setting of adjustable mast should only be assigned to STERIS personel or to personel that have been
Y previously trained by STERIS for those purposes.
Note: The XLED® light head and spring arm may be mounted at STERIS facilities if they are ordered at the same time as the mobile support.
If this is not the case, they are delivered separately in their specific packaging.
XLED® Mobile may be unpacked and installed by one person when delivered fully assembled.
The following personal protective equipments are required for unpacking / installing the XLED® Mobile:
- Safety goggles or glasses
- Gloves
- Steel toe shoes
6.1 UNPACKING/PACKING
Unpacking
1) Remove the top cover and the side plate of the transportation box.
2) Remove the fixing elements and preserve the parts for future use (wedges, ramps, foams, straps).
3) Put the ramps on the edge of the box.
4) Put the side plate on the ramps.
5) Descend the mobile unit by rolling it on the side plate.
wedges straps Packing/Unpacking guide

XLED Mobile
foams ramps side plate

Packing
proceed in reverse order
[8]
6.2 INSTALLATION OF THE MOBILE UNIT
1) Remove the elastic cord (3).
2) Unscrew the stop (2).
3) Rotate the spring arm 180 degrees by holding it continuously. Warning, during rotation, there are tilt hazards of the mobile support.
4) Screw the stops (2).
6.3 DEPLOYMENT OF THE MAST

1) Make sure that the pneumatic valve (3) is closed
2) Unlock the handle (1) and use the hand pump (4) to deploy the upper part of the mast, until it reaches the desired height
3) Lock the handle (1)
4) Unlock the handle (2) and use the hand pump (4) to deploy the lower part of the mast, until it reaches the desired height
5) Lock the handle (2)
closed
opened
[9]
6.4 INSTALLATION VERIFICATION
°
20
- Check the mobile unit suspension movement
°
- Ensure that the suspension system moves through all articulations smoothly
20
without friction. Light heads and arms should move smoothly and easily. When
positioned, the light head support arms should not drift. If friction or drifting is
present in suspension movements, call STERIS to make adjustments.
70°
- Ensure that all four mobile stand casters roll and swivel freely. Ensure that the
locking mechanisms of rear casters lock and unlock correctly.
70°
310°
>360°
Max : 2459
310°
>360°
Max : 2459
WARNING
2036
Avoid bumping the spring arm on the stops (1

& 2), there may cause premature wear of the
2036
spring arms.
914
914
°
20
°
20
20
°
20

°
Dessiné par:
M. BESNARD
Approuvé par: .
J.M. L'HEGARAT
Echelle: 1:2 MASSE
g HOMOLOGATION
.
N° ETUDE: 5/7
. 01

Dessiné par:
M. BESNARD
Approuvé par: .
J.M. L'HEGARAT
Echelle: 1:5 MASSE
g HOMOLOGATION
.
N° ETUDE: 2/8
Dessiné
. le: DECOR / TRAITEMENT ETS TOLERANCES GENERALES 01
Dessiné par:
M. BESNARD
Approuvé par: .
J.M. L'HEGARAT
Echelle: 1:5 MASSE
g HOMOLOGATION
.
N° ETUDE: 2/8
. 01
[10]
7. INSTALLING THE STERILISABLE HANDLE
Installing / removing the sterilisable handle
1) Set-up
Insert the sterilisable handle (3) onto its mount (2)
and orient it by turning it until you hear a "click" (2)
indicating that the handle is in place. “Clic”
(3) (3)
2) Removal
To remove the sterilisable handle (3) from the light,
keep the push-button (1) pressed down while (2)
(1)
pulling the handle downwards, to remove it from
its mount (2).
(3)
(3)
8. OPERATING INSTRUCTIONS power cord
8.1 CONNECTING TO THE MAINS

1) Place mobile stand at desired location.
2) Connect female (1) end of power cord to IEC connector located on the lower
rear of the mobile stand base (2).
3) Route the power cord to the wall receptacle so that it will not be tripped over,
then plug it into an appropriate receptacle.
4) Control of the light is possible using the control panel located on the yoke.
8.2 USE OF LOCAL LIGHT CONTROL 4 1

The light may be switched on by pressing (1)

The light intensity level may be adjusted using (2) and (3): the light intensity level
indicator (5) 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 or by holding the button down until the desired
level of lighting is obtained.
02 Maj référence et ajout tendeur 22/11/2012 MB JML
07/11/2012
Pressing (4) switches to ambient lighting or returns to surgical lighting if previously

02 Maj référence et ajout tendeur 22/11/2012 MB JML
Dessiné par: Ind Modifications N° Date Nom Appr
M. BESNARD
NOTE DE CALCUL MATIERE Casser les angles R= . x Chanfrein de .
Approuvé par: . à 45° x Façonnage Ra . x Pièce ébavurée
J.M. L'HEGARAT
switched off.
Echelle: 1:2.1 MASSE
164930.23 g HOMOLOGATION
. 07/11/2012
XLED mobile demo unit

N° ETUDE: 1/1
Dessiné par:
. 5 800 09 990 02 M. BESNARD
Approuvé par: .
J.M. L'HEGARAT
Echelle: 1:2.1 MASSE
164851.18 g HOMOLOGATION
.
3 2 5 N° ETUDE:
XLED mobile demo unit
1/1
. 5 800 09 990 02
580001046 indice 0
4 1 6
8.3 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 5000K
obtained. 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
RAL7035
RAL 7036
RAL9010
[11]
coupole couleur température caméra
8.4 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 set Wavelens ON, the spot size is set
to minimum. to maximum.
8.5 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.
Note: the Wavelens function is maintained on the 3 spot lightheads when the
camera is in position.
8.6 POSITIONING THE MOBILE UNIT

Light heads can be positioned by using either the light handle, or by grasping
the light head. To optimize shadow control, position the light head as appropriate
before starting the intended surgical procedure or examination. The following
picture describes an example of positioning with the XLDV3SW light head.
The appropriate working range is at a distance of 70-150cm between the
lighthead and the wound area.
1000
8.7 USE OF THE WHEEL BRAKES

20
Wheel brakes
628
x4 To brake: press the pedal STOP (b) down

a To release brake: put the pedal STOP in high position (a)
20
°
741
b

Dessiné par:
M. BESNARD
Approuvé par: .
J.M. L'HEGARAT
Echelle: 1:5 MASSE
g HOMOLOGATION
.
N° ETUDE: 2/7
. 01
[12]
8.8 TRANSPORTING THE MOBILE UNIT (FROM ONE ROOM TO ANOTHER)
1) Unlock the handle (1) located at the lower part of the mast.
2) Unlock the pneumatic valve (2). Beware of pinching hazards when the mast retracts.
3) If the mast does not retract, possibility to help it to retract by pushing the top of the mast (3).
4) Lock the handle (1). In this position, the XLED® Mobile can pass under the doors
5) If the mast shall be fully retracted, then repeat the steps 1 to 4 with the handle located at the upper part of the mast.
6) After having retracted the mast to the desired height, then lock the pneumatic valve (2)
7) Lower the light head and secure it in place with the safety elastic cord (4) before moving (rolling) the mobile stand.
8) Rotate the lighthead so that the underside is parallel to the mast, as shown in the picture on the right below.
Pinching hazard
to pass under the doors

< 2000mm
Can be lowered (<2000mm) to pass under doorways.
[13]
9. CLEANING / DISINFECTION / STERILIZATION
- Rinsing: Remove the detergent solution completely, rinsing with plenty of
The user should contact the sanitary specialists in the hospital to ensure clean water.
compliance with national hygiene and disinfection requirements (standards and
directives). The recommended products and procedures should be applied. If in 9.2.4 - Drying
doubt concerning the compatibility of the active substances to be used, contact
the local STERIS after-sales support department. - Wipe the handle using a lint-free clean cloth.
- Before use, the handles should undergo steam sterilisation.
9.1 - CLEANING AND DISINFECTING THE LIGHT: 9.2.5 - Sterilisation

Before cleaning, check that the light has been switched off and has cooled down. The previously cleaned handles should undergo steam sterilisation, according to
Wear the recommended personal protective equipment (gloves, goggles). the following instructions and cycles:
After cleaning procedures on mobile versions, ensure that no residual water
remains on the mains socket IEC. Country Sterilization Temperature Time [min]
Remove all water residue before connecting the power cord to the mains. cycle
General cleaning, disinfection and safety instructions: USA & Gravity 250°F 30
Canada 121°C
- Remove the sterilisable handles.
- Clean the system using a surface detergent and follow the manufacturer's USA & Pre-vacuum 270°F 4
dilution and temperature recommendations. Canada 132°C
- Rinse the appliance with a well-wrung cloth, wipe and leave to dry.
- Apply a disinfectant evenly, according to the manufacturer's recommendations. USA & Pre-vacuum 275°F 3
- Leave to dry. Canada 135°C
- Rinse with a well-wrung cloth, to remove any residue (particularly products France ATNC (Prion) 134°C 18
containing aldehydes, quaternary ammonium, surfactants). (Pre-vacuum)
- Steam cleaning procedure is not recommended for this equipment.
Other Pre-vacuum Comply with national
Cleaning the lighting surface countries regulations
- Check that the power supply has been switched off and that it has cooled
down sufficiently. - Ensure that each handle is clean before continuing the process.
- Wear rubber gloves. - Wrap the handles in sterilisation wrap (double wrap or equivalent).
- Prepare an approved disinfectant or cleaning solution according to the - The handles can also be packed in paper/plastic sterilisation bags, for easier
instructions given on the packaging label. identification and reuse.
- NEVER SPRAY ANYTHING directly onto the the light. Moisten a soft cloth - Place the handles, with the opening facing down, on the steriliser trays.
using cleaning solution and squeeze out the excess moisture. - Attach the biological and/or chemical indicators for monitoring the sterilisation
- Scrub the surfaces to be cleaned thoroughly. process, according to current regulations.
- Rinse all the surfaces using a clean a well-wrung cloth and clear water. - Start the sterilisation cycle, according to the steriliser manufacturer's
- Wipe all the surfaces with a clean well-wrung cloth. instructions.
- Make sure that the sterilisable plastic handle (if used) is sterilised using a
standard hospital cycle. 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
Examples of recommended products sterilizable handle:
STERIS recommends the use of cleaning and disinfectant chemicals whose
compounds are based on isopropyl alcohol (<45%) or based on a quaternary - Check that there is no cracking and that the latch works.
ammonium. - Replace the handle if it shows crack or deformation.
The use of cleaning chemicals not listed by STERIS is not recommended - Refit the handle in the light and lock by turning (click)
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®.
9.2 CLEANING AND STERILISING STERILISABLE

HANDLES
9.2.1 - 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.
9.2.2 - Cleaning
- Immerse the handles in a detergent solution.
- Follow the manufacturer's recommendations.
9.2.3 - 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.
[14]
10. LIST OF RECOMMENDED SPARE PARTS
REFERENCES DESCRIPTIONS
XHAND5 Kit of 5 XLED® sterilisable handles
11. QUICK TROUBLESHOOTING GUIDE

FAULT OBSERVED POSSIBLE CAUSE CORRECTIVE ACTION
Light does not switch on - Mains power voltage - Check whether another appliance is running on the same system
- Other cause - Call the STERIS after-sales department
The sterilizable handle does not insert into the - Sterilization setting overshoot (temperature, - Check that the locking mechanism (audible click) and the handle
mount correctly time) assembly work
- The maximum service life has been exceeded/ - Replace the handle
the handle is deformed
Light deviation - The brakes are not fastened tightly enough - Call the STERIS after-sales department
- Adjust the brakes
Light too flexible or too hard to handle - Incorrect brake setting - Adjust the balancing system
- Lack of lubrication - Call the STERIS after-sales department
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.
12. ENVIRONMENTAL PROTECTION

Product recycling: this equipment should be disposed of with a licensed electrical and electronic component recycling authority.
13. MAINTENANCE SCHEDULE

13.1- PREVENTIVE MAINTENANCE b.2 - Other inspections
To retain the initial performances and reliability of your surgical light, maintenance and - Nominal lighting: see technical data.
inspection operations should be performed once a year as follows: - Balancing system setting.
- Sterilisable handle locking mechanism.
- During the warranty period, by a STERIS technician or a STERIS-approved agent, - Visual inspection inside and outside the lighthead
- Outside the warranty period, by a STERIS technician or a STERIS-approved agent, or - Control of the commands (keypad), proper operation of the buttons, etc.
the hospital technical department.
For this type of procedure, contact the STERIS-approved after-sales support
Before any maintenance, check that the light has been switched off and has cooled department. The circuit diagrams, component lists, technical descriptions or any other
down useful information for the personnel assigned to install the XLED light are available from
STERIS on request.
13.2 - LEVEL ONE MAINTENANCE
a) Daily inspection:
- Check that the sterilisable handle clicks into place and locks correctly.
- Check the position of the arm.
The daily inspection must be performed by qualified personnel
Loose or damaged parts may fall into wounds. To ensure the safety of the patient,
make a daily check of the components of the equipment and ensure there are no loose
parts on the lighthead and no visible damage, especially on the covers of the product.
b) Annual inspection (should be carried out by an approved technician):
b.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.
- Check the stops (angular angles...)
- Check the caster and brakes
[15]
14 - ELECTROMAGNETIC ENVIRONMENT
Essential performance of XLED® Mobile 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® Mobile, 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® Mobile 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® Mobile 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® Mobile should assure that it is used Power cord 689400010
in such environement.
Emission test Compliance Electromagnetic environment – guidance

Electromagnetic radiation disturbance (radiated emissions) The XLED® Mobile uses RF energy only for its internal function.
CISPR 11 Groupe 1 Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Mains terminal disturbance voltage (conducted emissions) 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
Classe A
CISPR 11 building used for domestic purposes.
IEC 61000-3-2 Harmonic emissions Not applicable Professionnal healthcare facility environment
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
IEC 61000-3-3 Voltage changes and fluctuations/ flicker 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
Not applicable relocating or re-orienting the equipment.
emissions
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® Mobile should assure that it is used in such environement.
©
Immunity test IEC 60601-test level Compliance level Electromagnetic environment guidance
Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact
IEC 61000-4-2 ±15 kV air ±15 kV air Professionnal healthcare facility environment
Electrical fast transient/burst ±2 kV on mains ±2 kV

IEC 61000-4-4 ±2 kV on inlet / outlet ±1 kV
Mains power quality should be that of a Professionnal healthcare facility 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 0% UT for 0,5 cycle at 0°, 45°, 90°, 135°, 0% UT for 0,5 cycle at 0°, 45°, 90°,
variations on power supply input lines 180°, 225°, 270° and 315° 135°, 180°, 225°, 270° and 315°
0% UT for 1 cycle and 70% for 25 cycles 0% UT for 1 cycle and 70% for 25 Mains power quality should be that of a Professionnal healthcare facility environment. If the user of XLED Mobile ®
IEC 6100-4-11 at 50Hz and for 30 cycles at 60Hz (single cycles at 50Hz and for 30 cycles at requires continued operation during power mains interruptions, it is recommended that the XLED Mobile be powered®
phase at 0°) 60Hz (single phase at 0°) from an uninterruptible power supply or a battery.
0% UT for 250 cycles at 50Hz and for 300 0% UT for 250 cycles at 50Hz and
cycles at 60Hz for 300 cycles at 60Hz
Power frequency (50/60 Hz) Power frequency magnetic fields should beat at levels characteristic of a typical location in a Professionnal
magnetic field 30 A/m 30 A/m healthcare facility environment.
IEC 61000-4-8
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 6V in ISM bands between 0,15 MHz
80 MHz and 80 MHz
80% MA at 1kHz 80% MA at 1kHz
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
80% MA at 1 kHz 80% MA at 1 kHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (1), should be less than
the compliance level in each frequency range (2) Interference may occur in the vicinity of equipment marked with the
9V/m 9V/m following symbol
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
[16]
[17]
STERIS SAS
STERIS SAS
OM202-01EN 2021-09 REVA XLED Mobile

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Mobile

Ind Modifications N° Date Nom Appr

. 01 Ind Modifications N° Date Nom Appr Ind Modifications N° D

Dessiné par: Dessiné par:

N° ETUDE: 1/4 N° ETUDE:

1. QUALITY REQUIREMENTS STERIS SAS

Intended use: Patient target group

* According to the version in force

Y Warning: This device cannot be modified without the manufacturer's authorisation.

Pinch points Maintenance

their entry in the mains socket IEC.

liable to affect or damage the lighting system.

Increase light intensity Decrease light intensity

Activate/Deactivate ambient lighting Backup power operation indicator

Select color temperature (only for XLED color temperature)

CMJN 49,0,1,0 Identification labels

Caution: consult accompanying documentsRAL 7036 Name and address of manufacturer

coupole couleur température caméra

No stepping on surface Alternating current

Direct current Protective earth ground

Equipotentiality plug Maximum weight of mobile demo unit

SN Serial number REF Product reference

Caution 0°C Temperature limit

MD Medical device 500

Fixed color temperature

Span 490 mm XLED® 3 SPOTS

Span 665 mm Span 785 mm

Variable color temperature

Span 490 mm Span 695 mm

Span 695 mm Span 785 mm

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

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

wedges straps Packing/Unpacking guide

foams ramps side plate

6.3 DEPLOYMENT OF THE MAST

Avoid bumping the spring arm on the stops (1

Ind Modifications N° Date Nom Appr

Ind Modifications N° Date Nom Appr

8. OPERATING INSTRUCTIONS power cord

8.1 CONNECTING TO THE MAINS

8.2 USE OF LOCAL LIGHT CONTROL 4 1

The light may be switched on by pressing (1)

Pressing (4) switches to ambient lighting or returns to surgical lighting if previously

XLED mobile demo unit

8.3 USE OF THE ADJUSTMENT TEMPERATURE COLOR

obtained. CMJN 0,73,94,0

8.5 SWITCHING ON AMBIENT LIGHTING

8.6 POSITIONING THE MOBILE UNIT

b) Annual inspection (should be carried out by an approved technician):