Johnson & Johnson DePuy Synthes SPOTLIGHT User manual

SPOTLIGHT™
Rigid Arm and
Bed Rail Clamp
Revised January 2016
© DePuy Synthes 2007-2016. All rights reserved.
0902-90-052
Rev.B
0086

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en
SPOTLIGHT™ Rigid Arm and Bed Rail Clamp
Assembly
The assembly of the set can be done easily and without additional tools. All the handles should be
handled with as little force as possible and as much force as necessary.
1. Put the rail clamping base to the rail of the surgery table and fix by turning the handle in the
clockwise direction (We recommend positioning the clamp so the turning handles are facing
upward and outward with respect to the table).
2. Place the column with one hand into the hole on the clamp base and fix the column’s position
with the other hand by turning the appropriate handle in the clockwise direction.
3. The desired height and orientation of the column including the articulated arm can be adjusted at
any time by loosening the handle on the clamp.
Important:
To do so, hold the column with one hand and loosen the handle with the other hand. When the
desired position is reached, again tighten the handle.
Warning:
If the rail clamping base is not correctly tightened, it may become loose which may cause injuries.
Disassembly
The disassembly of the set can be likewise performed without additional tools and fundamentally
proceeds in the reverse order of the assembly:
Important:
Hold the joint support with one hand and loosen the appropriate handle on the clamp base with
the other hand.
1. Pull the articulated arm including the column from the hole in the clamp base.
2. Lift the rail clamping base from the rail of the surgery table after loosening the appropriate handle.

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Instructions For Use For the Articulated Arms
1
3
24
Z
Holding-Releasing-Positioning-Fixing-Controlling:
1. Hold the articulated arm with one hand in the anterior segment and with the other hand manipulate
the clamping device.
2. To release turn the central handle (Z) in the counter clockwise direction, all the way as far
as necessary
3. Bring the apparatus in the desired position
4. To fix turn the central handle (Z) in the clockwise direction
5. Control, check the function of the articulated arm
Warning:
If the articulated arm is not tightened properly it can move and become loose, potentially
causing injuries.
Do not put excessive weight on the articulated arm.
The articulated arm can transmit electrical current and heat to the patient. The contact between the
articulated arm and the sources of current and/or heat must be absolutely avoided.
ATTENTION:
The fixation of the articulated arm is based on the principle of friction. Changing the position without
loosening the clamping mechanism can cause damage and will shorten the lifespan.
The articulated arm can be adjusted with little force. If the central clamping handle (Z) has been
fully loosened it has to be turned in the clockwise direction.
Store the articulated arm to protect it from damage.
Reuse
All the instruments and components must be cleaned, disinfected, and sterilized before each
use; this specifically applies also for the first use after delivery because all the instruments are
non-sterile when delivered. Adequate cleaning and disinfection is an absolute prerequisite for
effective sterilization.

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Ensure that only validated instrument- and product-specific procedures are used for cleaning,
disinfection, and sterilization, that the apparatus used (disinfection apparatus, sterilization apparatus)
is serviced and checked regularly, and that validated parameters are used in each cycle.
Local hospital policies and/or applicable regulations, such as those pertaining to effective prion
inactivation, should also be followed.
WARNING:
The articulated arm should not be immersed in liquids.
Cleaning and disinfection
For the cleaning and disinfection of the instruments a mechanical procedure (disinfecting apparatus)
is used. A manual procedure should never be used.
The articulated arm should not be immersed in liquids.
The pre-treatment is performed as described below.
WARNING:
Before use, all the products should be removed from the transport packaging. Other packaging,
protective caps and foils, etc. should be removed and disposed off, respecting the environment.
The central handle of the articulated arm must be tightened during pre-handling and cleaning/
disinfection.
NOTE:
All the products will be delivered non-sterile. Please clean, disinfect, and sterilize the products
before the first use according to the instructions.
Pre-treatment
Directly after use (within maximally 2 hours), major soiling must be removed from the products.
Tighten the central handle of the articulated arm and place under running water or a disinfection
liquid; the disinfecting agent should be aldehyde-free (otherwise blood soiling will be fixed), should
have proven efficacy, should be suitable to disinfect instruments, and should be compatible with
the instruments.
Material Durability
When choosing cleaning and disinfecting agents, please make sure that they do not contain
the following:
•No organic/inorganic, respectively oxidizing acids (pH should not be less than 4, the use of
neutral/enzymatic agents is recommended)
•No bases (pH should not be higher than 9, the use of neutral/enzymatic agents is recommended
•Solvents (alcohol, benzene, acetone, etc.)
•Phenol

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•Chlorine, bromine, iodine
•Chlorine salts (in particular ammonium chloride compounds), chlorinated/halogenated hydrocarbons
•Oxidizing agents, peroxide, hypochloride
Do not clean any of the instruments with metal brushes or steel wool.
All the instruments should not be exposed at temperatures higher than 137°C (279°F)
ATTENTION:
For the manual removal of soiling only use a soft brush or a clean soft cloth that are only used for
this purpose, never metal brushes or steel wool.
Please note that the disinfectant used for the pre-treatment serves only to help protect the handler
and cannot replace the mandatory disinfection step that has to be performed subsequently after
completion of cleaning.
NOTE:
Always observe the instructions for use from the manufacturer of the cleaning and
disinfection solutions.
WARNING:
Use as much cleaning agent and cleaning liquid as necessary and remove surplus cleaning agent
with a dry cloth.
Instruments made of aluminium alloys, such as the bed rail clamp, will be damaged by basic
(pH > 9) cleaning agents and solvents.
Sterilization
All SPOTLIGHT™ Access System instruments and components are reusable instruments that must
be sterilized before use.
Recommendations for Steam Sterilization:
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 6 min.
To ensure effective sterilization, it is critical that the steam sterilizer be properly maintained,
calibrated, and validated for applicable load configurations. A facility may choose to use a different
steam sterilization cycle than the cycle suggested, if the facility has properly validated the cycle for
the instrument(s) being sterilized.
For further information related to the use of this instrument, please contact your DePuy Spine
representative, or distributor.

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Inspection for Damage
Do not use the instrument if it is damaged or if the ease of movement or the clamping force
is insufficient.
Instrument oil may never be used.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE SOLD WITH A LIMITED WARRANTY
TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY
OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS, ARE HEREBY DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF
THIS INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE FOR
CURRENT INFORMATION AT [phone] OR AT [phone].
MATERIAL
MATL
SYMBOL TRANSLATION
A/T ACROFLEX
®
/Ti
ACROFLEX
®
/Titanium
AAI
Aluminum
A/P Al/PL
Aluminum/Plastic
B/R Ba/RADEL
®
Barium/RADEL
®
Ba/PEEK
Barium Sulfate (BaSO
4
)/
PEEK Polymer
CaP
CALCIUM PHOSPHATE
Calcium Phosphate
CM CoCrMo
Cobalt Chromium
Molybdenum
CMTC
CoCrMo/Ti/CALCIUM
PHOSPHATE
Cobalt Chromium
Molybdenum/Titanium/
Calcium Phosphate
CoNiCrMo
Cobalt Nickel
Chromium Molybdenum
FFOAM
Foam
HA
Hydroxyapatite
NiTi Ni/Ti
Nickel/Titanium
PL
Plastic
SRSI
SS/RADEL
®
/SILICONE
Stainless Steel/RADEL
®
/
Silicone
SRSN
SS/RADEL
®/
SILICONE/Ti Al Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium
Aluminum Nitride
SS/RADEL
®/
SILICONE/Ti
Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium Nitride
SRTA
SS/RADEL
®
/Ti Al Nitride
Stainless Steel/RADEL
®
/
Titanium Aluminum Nitride
STA SS/Ti Al Nitride
Stainless Steel/
Titanium Aluminum Nitride
S/U SS/ULTEM
Stainless Steel/Ultem
TTi
Titanium and its alloys
S/R SS/RADEL
®
Stainless Steel/RADEL
®
R/T
POLYOLEFIN RUBBER/Ti
Polyolefin Rubber/Titanium
T/ATi/Al
Titanium/Aluminum
Ti/CoCrMo
Titanium/Cobalt
Chromium Molybdenum
P/F PL/FOAM
Plastic/Foam
PY
Polyester
PEEK/C
PEEK/CARBON
FIBER COMPOSITE
Polyether Ether Ketone/
Carbon Fiber Composite
PEEK OPTIMA®
Polyether Ether Ketone
PPOLYMER
Polymer
P/CM PE/CoCrMo
Polyethylene/Cobalt
Chromium Molybdenum
P/C
POLYMER/CARBON
FIBER COMPOSITE
Polymer/
Carbon Fiber Composite
Si/NITINOL
Silicone/Nitinol
SSS
Stainless Steel
S/A SS/Al
Stainless Steel/Aluminum
SBR SS/Ba/RADEL
®
Stainless Steel/Barium/
RADEL
®
S/P SS/PHENOLIC
Stainless Steel/Phenolic
S/PLSS/PL
Stainless Steel/Plastic
LOT LOT NUMBER
REF REF
CATALOG NUMBER
QTY QUANTITY
SZ SIZE
MADE IN MADE IN
NTI
NEURAL TISSUE
INSTRUMENT
IOM
NEUROMONITORING
INSTRUMENTS
Federal (USA) law
restricts this device
to sale by or on the
order of a physician
DO NOT RESTERILIZE
T2
T1
Lower Limit of
temperature
= T1
Upper Limit of
temperature
=
T2
25°C
STORE AT ROOM
TEMPERATURE
KEEP AWAY FROM
SUNLIGHT
SINGLE USE
ATTENTION.
SEE INSTRUCTIONS
FOR USE
PACKAGE CONTAINS
FLAMMABLE LIQUID
DO NOT USE
IF PACKAGE IS
DAMAGED
MSR
MEASURING DEVICE
STERILE
STERILE
STERILE A
Sterile medical device
processed using
aseptic technique
STERILE R
STERILIZATION BY
IRRADIATION
STERILE EO
STERILIZATION BY
ETHYLENE OXIDE
LATEX FREE
LATEX FREE
NON
STERILE
NONSTERILE
NONSTERILE
MANUFACTURER
DATE OF
MANUFACTURE
US REP
US REPRESENTATIVE
EC REP
AUTHORIZED
EUROPEAN
REPRESENTATIVE
DIST
DISTRIBUTED BY
XXXX-XX
USE BY
Ti/HA
Titanium/Hydroxyapatite
Ti/UHMWPE/HA
Titanium/Ultra-High
Molecular Weight
Polyethylene/Hydroxyapatite
SS/Ti
Stainless Steel/Titanium
SS/Al/SILICONE
Stainless Steel/
Aluminum/Silicone
SS/SILICA GLASS
Stainless Steel/Silica Glass
SS/SILICA GLASS/
PL/SILICONE
Stainless Steel/Silica Glass/
Plastic /Silicone
SS/SILICA GLASS/
RADEL
®/SILICONE
Stainless Steel/Silica Glass/
RADEL
®
/Silicone
SS/SILICA GLASS/
SILICONE
Stainless Steel/
Silica Glass/Silicone
S/SISS/SILICONE
Stainless Steel/Silicone
SS/WC/SILICONE
Stainless Steel/Tungsten
Carbide/Silicone
W/C
Tungsten Carbide

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MATERIAL
MATL
SYMBOL TRANSLATION
A/T ACROFLEX
®
/Ti
ACROFLEX
®
/Titanium
AAI
Aluminum
A/P Al/PL
Aluminum/Plastic
B/R Ba/RADEL
®
Barium/RADEL
®
Ba/PEEK
Barium Sulfate (BaSO
4
)/
PEEK Polymer
CaP
CALCIUM PHOSPHATE
Calcium Phosphate
CM CoCrMo
Cobalt Chromium
Molybdenum
CMTC
CoCrMo/Ti/CALCIUM
PHOSPHATE
Cobalt Chromium
Molybdenum/Titanium/
Calcium Phosphate
CoNiCrMo
Cobalt Nickel
Chromium Molybdenum
FFOAM
Foam
HA
Hydroxyapatite
NiTi Ni/Ti
Nickel/Titanium
PL
Plastic
SRSI
SS/RADEL
®
/SILICONE
Stainless Steel/RADEL
®
/
Silicone
SRSN
SS/RADEL
®/
SILICONE/Ti Al Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium
Aluminum Nitride
SS/RADEL
®/
SILICONE/Ti
Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium Nitride
SRTA
SS/RADEL
®
/Ti Al Nitride
Stainless Steel/RADEL
®
/
Titanium Aluminum Nitride
STA SS/Ti Al Nitride
Stainless Steel/
Titanium Aluminum Nitride
S/U SS/ULTEM
Stainless Steel/Ultem
TTi
Titanium and its alloys
S/R SS/RADEL
®
Stainless Steel/RADEL
®
R/T
POLYOLEFIN RUBBER/Ti
Polyolefin Rubber/Titanium
T/ATi/Al
Titanium/Aluminum
Ti/CoCrMo
Titanium/Cobalt
Chromium Molybdenum
P/F PL/FOAM
Plastic/Foam
PY
Polyester
PEEK/C
PEEK/CARBON
FIBER COMPOSITE
Polyether Ether Ketone/
Carbon Fiber Composite
PEEK OPTIMA®
Polyether Ether Ketone
PPOLYMER
Polymer
P/CM PE/CoCrMo
Polyethylene/Cobalt
Chromium Molybdenum
P/C
POLYMER/CARBON
FIBER COMPOSITE
Polymer/
Carbon Fiber Composite
Si/NITINOL
Silicone/Nitinol
SSS
Stainless Steel
S/A SS/Al
Stainless Steel/Aluminum
SBR SS/Ba/RADEL
®
Stainless Steel/Barium/
RADEL
®
S/P SS/PHENOLIC
Stainless Steel/Phenolic
S/PLSS/PL
Stainless Steel/Plastic
LOT LOT NUMBER
REF REF
CATALOG NUMBER
QTY QUANTITY
SZ SIZE
MADE IN MADE IN
NTI
NEURAL TISSUE
INSTRUMENT
IOM
NEUROMONITORING
INSTRUMENTS
Federal (USA) law
restricts this device
to sale by or on the
order of a physician
DO NOT RESTERILIZE
T2
T1
Lower Limit of
temperature
=
T1
Upper Limit of
temperature
= T2
25°C
STORE AT ROOM
TEMPERATURE
KEEP AWAY FROM
SUNLIGHT
SINGLE USE
ATTENTION.
SEE INSTRUCTIONS
FOR USE
PACKAGE CONTAINS
FLAMMABLE LIQUID
DO NOT USE
IF PACKAGE IS
DAMAGED
MSR
MEASURING DEVICE
STERILE
STERILE
STERILE A
Sterile medical device
processed using
aseptic technique
STERILE R
STERILIZATION BY
IRRADIATION
STERILE EO
STERILIZATION BY
ETHYLENE OXIDE
LATEX FREE
LATEX FREE
NON
STERILE
NONSTERILE
NONSTERILE
MANUFACTURER
DATE OF
MANUFACTURE
US REP
US REPRESENTATIVE
EC REP
AUTHORIZED
EUROPEAN
REPRESENTATIVE
DIST
DISTRIBUTED BY
XXXX-XX
USE BY
Ti/HA
Titanium/Hydroxyapatite
Ti/UHMWPE/HA
Titanium/Ultra-High
Molecular Weight
Polyethylene/Hydroxyapatite
SS/Ti
Stainless Steel/Titanium
SS/Al/SILICONE
Stainless Steel/
Aluminum/Silicone
SS/SILICA GLASS
Stainless Steel/Silica Glass
SS/SILICA GLASS/
PL/SILICONE
Stainless Steel/Silica Glass/
Plastic /Silicone
SS/SILICA GLASS/
RADEL
®/SILICONE
Stainless Steel/Silica Glass/
RADEL
®
/Silicone
SS/SILICA GLASS/
SILICONE
Stainless Steel/
Silica Glass/Silicone
S/SISS/SILICONE
Stainless Steel/Silicone
SS/WC/SILICONE
Stainless Steel/Tungsten
Carbide/Silicone
W/C
Tungsten Carbide

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cz
Rigidní rameno a svorka na postelovou kolejnici
SPOTLIGHT™
Souprava
Sestavení soupravy je možné provést snadno a bez dalších nástrojů. Se všemi kličkami je třeba
zacházet s co nejmenší silou, tedy jen s nejnutnější.
1. Umístěte základnu svorky na kolejnici chirurgického stolu a upevněte ji otočením kličky ve směru
hodinových ručiček (doporučujeme umístit svorku tak, aby otočné kličky směřovaly nahoru a ven
vzhledem ke stolu).
2. Umístěte sloupek jednou rukou do otvoru základny svorky a druhou rukou upevněte polohu
sloupku tím, že otočíte odpovídající kličkou ve směru hodinových ručiček.
3. Požadovanou výšku a orientaci sloupku včetně kloubového ramene je možné upravit kdykoliv
uvolněním kličky na svorce.
Důležité:
Uděláte to tak, že jednou rukou podržíte sloupek a druhou rukou uvolníte kličku. Jakmile
dosáhnete požadované polohy, kličku znovu utáhnete.
Upozornění:
Pokud není základna svorky kolejnice správně utažená, může se uvolnit a způsobit poranění.
Demontáž
Demontáž soupravy se provádí podobným způsobem, bez dalších nástrojů, a v podstatě probíhá v
opačném pořadí než sestavování:
Důležité:
Jednou rukou držte oporu kloubu a druhou rukou uvolněte odpovídající kličku základny svorky.
1. Vytáhněte kloubové rameno včetně sloupku z otvoru v základně svorky.
2. Jakmile uvolníte odpovídající kličku, můžete zvednout základnu svorky kolejnice z kolejnice
chirurgického stolu.

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Návod k použití pro kloubová ramena
1
3
24
Z
Držení – uvolňování – polohování – fixování – kontrola:
1. Držte kloubové rameno jednou rukou v předním segmentu a druhou rukou manipulujte se
svorkovacím prostředkem.
2. Pro uvolnění otočte střední kličkou (Z) proti směru hodinových ručiček, co nejdále.
3. Uveďte nástroj do požadované polohy.
4. Pro zafixování otočte centrální kličkou (Z) ve směru hodinových ručiček.
5. Kontrola – zkontrolujte funkci kloubového ramene.
Upozornění:
Pokud kloubové rameno není správně utažené, může se pohybovat nebo uvolnit a potenciálně
způsobit poranění.
Na kloubové rameno nepůsobte nadměrnou silou.
Kloubové rameno může přenášet elektrický proud a teplo na pacienta. Je třeba zcela zabránit
kontaktu mezi kloubovým ramenem a zdroji proudu a/nebo tepla.
UPOZORNĚNÍ:
Fixace kloubového ramena je založena na principu tření. Změna polohy bez uvolnění svorkového
mechanismu může způsobit poškození a zkrátit životnost.
Kloubové rameno je možné nastavit malou silou. Pokud byla centrální svorkovací klička (Z) zcela
uvolněná, je třeba ji otočit ve směru hodinových ručiček.
Při skladování chraňte kloubové rameno před poškozením.
Opakované použití
Všechny nástroje a komponenty je třeba čistit, dezinfikovat a sterilizovat před každým použitím.
To platí zejména na první použití po dodání, protože všechny nástroje jsou při dodávce nesterilní.
Adekvátní čištění a dezinfekce je absolutním předpokladem pro efektivní sterilizaci.
Ujistěte se, že pro čištění, dezinfekci a sterilizaci se používá pouze validovaný nástroj a postupy
specifické pro produkt, že se u použitého přístroje (dezinfekční nebo sterilizační přístroj) provádí
pravidelná údržba a kontrola a že se validované parametry používají v každém cyklu.