Care Fusion Spetzler V.Mueller User manual

DCN 43699 Vernon ills, IL Alex Giraldo 01-28-16 36-3488 E
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Spetzler™ Reusable Skull Pins
Épingles réutilisables Spetzler pour crâne
Spetzler Wiederverwendbare Schädelstifte
Perni cranici riutilizzabili Spetzler
Clavos craneales reutilizables Spetzler
Pinos de fixação do crânio reutilizáveis Spetzler
Spetzler herbruikbare schedelpennen
Spetzler återanvändbara skallfixeringsstift
Spetzler Genbrugelige Kraniestifter
Spetzler- uudelleenkäytettävät kallotapit
Spetzler gjenbrukelige kraniestifter
Πείροι κρανίου Spetzler πολλών χρήσεων
Spetzler再使用可能スカルピン Lebeční kolíky Spetzler na mnohonásobné použití
Trzpienie czaszkowe wielokrotnego użytku Spetzler
Spetzler eniden Kullanılabilir Kafatası Çivileri
Ştifturi craniene refolosibile Spetzler
V. Mueller ™
Rx Only
USA
V. Mueller, CareFusion, and Carefusion logo are
trademarks or registered trademarks of CareFusion
Corporation, or one of its affiliates.
Spetzler is a trademark of Dr. Robert F. Spetzler MD.
CareFusion
75 North Fairway Drive
Vernon ills, IL 60061 USA
CareFusion France 309 S.A.S.
8 bis rue de la Renaissance
44110 Châteaubriant - France
36-3488E • 2016-01
0123
© 2010, 2012, 2015, 2016 CareFusion Corporation
or one of its affiliates. All rights reserved.
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Manufactured By
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DCN 43699 Vernon ills, IL Alex Giraldo 01-28-16 36-3488 E
Proofed by: ____________________________ Date: _____________
Dimensions chec ed: ______________ Copy chec ed: _____________
Catalog Numbers
Catalog # Description
M-1540 Spetzler Reusable Adult Skull Pins
M-1545 Spetzler Reusable Pediatric Skull Pins
Indications for Use
V. Mueller Neuro/Spine Products comprising surgical instruments that
provide rigid 3-point skeletal fixation for the supine, prone, lateral or sitting
positions, craniotomies in all positions and cervical laminectomies (upper
dorsal approach).
How Supplied
The Spetzler reusable skull pins are packaged as non-sterile. Cleaning and
sterilization must occur prior to use.
Please reference product instructions for use (36-3518) for complete
operating and use instructions for the Spetzler eadrest System that can be
used with these skull pins.
Limitations on Reprocessing
Repeated reprocessing has minimal effect on these devices. End of life is
normally determined by wear and damage due to use.
Warnings
Devices shall be used in accordance with these instructions for use. Read all
sections of this insert prior to use. Improper use of this device may cause
serious injury. In addition, improper care and maintenance of the device may
render the device non-sterile prior to patient use and cause a serious injury
to the patient or health care provider.
Any variation between what is suggested here and your facility’s policies and
procedures should be brought to the attention of the appropriate responsible
persons for direction before using your instruments. Prior to use, all
instruments should be inspected to insure proper function and condition. Do
not use instruments if they do not perform satisfactorily in an operational
test.
Do not position skull pins over the frontal sinuses, the temporal fossa, and
major vessels and nerves of the skull. Avoid puncture of the superficial
temporal artery.
Special care should be exercised on pediatric patients due to thin skull
consistency. Spetzler Skull Pins should not be used on children under five
(5) years of age.
Special care should be exercised with use on the elderly, on restored
surgical areas surrounding previous burr holes, or any diseased bone
because of varying consistencies and thickness from that of healthy bone.
A minimum of 60 lbs (27 kg) force must be applied to the skull clamp. Skull
clamp force above 80 pounds (36 kg) could cause harm to the patient.
Do Not Exceed 80 lbs of force when turning the Torque Knob.
Skull pins should penetrate the scalp at an angle that intersects the center of
the cranial vault. Never sharpen skull pins. Dull or damaged pins should be
discarded and replaced.
The Spetzler Skull Pin must be fully seated so that there are no gaps
between the shoulder of the skull pin and the receptacle into which it has
been inserted. Skull pins should not be centered over the frontal sinuses or
the temporal area of the skull. Failure to properly position the patient and to
fully tighten all adjustment portions of the device may result in patient injury
or death.
en
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DCN 43699 Vernon ills, IL Alex Giraldo 01-28-16 36-3488 E
Proofed by: ____________________________ Date: _____________
Dimensions chec ed: ______________ Copy chec ed: _____________
To maintain proper fixation, skull pins should be of equal length. If a
discrepancy exists, do not use the skull pins.
Cautions
If there are any variations between these instructions and either your
facility’s policies and/or your cleaning/sterilization equipment manufacturer’s
instructions, those variations should be brought to the attention of the
appropriate responsible hospital personnel for resolution before proceeding
with cleaning and sterilizing your devices.
Use of device for a task other than that for which it is intended will usually
result in a damaged or broken device.
Spetzler Skull Pins should be used solely with the Spetzler eadrest System
as these are the only pins validated for use with the system.
Prior to use, inspect device to ensure proper function and condition. Do not
use devices if they do not satisfactorily perform their intended function or
have physical damage.
The potential for Venous Air Embolism (VAE) exists any time the surgical
wound is above the level of the heart. Proper monitoring for VAE until
removal of the skull pins is highly recommended.
Only the cleaning and sterilization processes which are defined within these
instructions for use have been validated.
Use only neutral p (6-8) detergent solutions.
re-processing Instructions
Initiate cleaning of device within 2 hours of use.
Transport devices via the institution’s established transport procedure.
Remove excess gross soil as soon as possible after use by rinsing or wiping
the device.
Manual Cleaning
1. Ensure all pre-processing instructions are followed prior to cleaning.
2. Prepare the enzymatic / neutral p detergent solution, utilizing tap water
with a temperature range of 27°C to 44°C (81°F to 111°F), per
manufacturer’s instructions.
3. Place device in the open/relaxed position, and completely immerse in the
detergent solution and allow device to soak for a minimum of 5 minutes.
Actuate all movable parts during the initiation of the soak time.
4. Using a soft bristled brush, remove all visible soil from the device.
Actuate device while brushing, paying particular attention to hinges,
crevices and other difficult to clean areas. Note: It is recommended that
the detergent solution is changed when it becomes grossly contaminated
(bloody and/or turbid).
5. Rinse the device by completely immersing in tap water with a
temperature range of 27°C to 44°C (81°F to 111°F), for a minimum of
30 seconds to remove any residual detergent or debris.
6. Dry the device with a clean, lint-free towel.
7. Visually examine each device for cleanliness.
8. If visible soil remains, repeat cleaning procedure.
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DCN 43699 Vernon ills, IL Alex Giraldo 01-28-16 36-3488 E
Proofed by: ____________________________ Date: _____________
Dimensions chec ed: ______________ Copy chec ed: _____________
Automatic Cleaning
1. Ensure all pre-processing instructions are followed prior to cleaning.
2. Clean the devices via the automatic cleaning parameters below.
3. If visible moisture is present, dry the instrument with a clean, lint-free
towel.
4. Visually examine each instrument for cleanliness.
5. If visible soil remains, repeat cleaning procedure.
Inspection/Maintenance
Proper care and handling is essential for satisfactory performance of any
surgical device. The previous cautions should be taken to ensure long and
trouble-free service from all your surgical devices. Inspect devices before each
use for broken, cracked, tarnished surfaces, movement of hinges, and chipped
or worn parts. If any of these conditions appear, do not use the device. Return
devices to an authorized repair service center for repair or replacement.
ackaging
Devices can be loaded into dedicated packaging systems. Sterilization wrap
material must be cleared for the applicable sterilization modality by your
country’s regulatory body. Use in accordance with packaging manufacturer’s
sterilization instructions being sure to protect jaws and cutting edges from
damage.
Sterilization
All devices must be processed in the completely open position (i.e. brackets,
levers, etc.) to allow sterilant contact of all surfaces.
All devices with concave surfaces shall be configured so that water pooling
does not occur.
HASE MINIMUM
RECIRCULATION
TIME
WATER
TEM ERATURE
DETERGENT
TY E AND CONCENTRATION
(IF A LICABLE)
Pre-Wash
115 Seconds Cold Tap Water
1°C - 16°C
(33°F - 60°F) N/A
Enzyme
Wash 1 Minute ot Tap Water
43°C - 82°C
(110°F - 179°F)
• Detergent: p -neutral/
enzymatic detergent
• Concentration: Per the
detergent manufacturer’s
recommendations
Wash 1 2 Minute ot Tap Water
43°C - 82°C
(110°F - 179°F)
• Detergent: p -neutral cleanser
• Concentration: Per the
detergent manufacturer’s
recommendations
Rinse 1 15 Seconds ot Tap Water
43°C - 82°C
(110°F - 179°F) N/A
Pure Rinse 10 Seconds Purified Water
43°C - 82°C
(110°F - 179°F) N/A
Drying N/A N/A N/A
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DCN 43699 Vernon ills, IL Alex Giraldo 01-28-16 36-3488 E
Proofed by: ____________________________ Date: _____________
Dimensions chec ed: ______________ Copy chec ed: _____________
revacuum Steam Sterilization arameters
Preconditioning Pulses: 3
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Dry Time: 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
Gravity Steam Sterilization arameters
Temperature: 132°C (270°F)
Exposure Time: 15 minutes
Dry Time: 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
Gravity Steam Sterilization arameters
Temperature: 121°C (250°F)
Exposure Time: 30 minutes
Dry Time: 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
EO Sterilization arameters
Sterilizer Cycle: 100% Ethylene Oxide (EO)
Preconditioning Time: 30 minutes
EO Gas Concentration: 725 mg/L
Temperature: 55°C (130°F)
umidity: 50-80%
Exposure Time: 60 minutes
Aeration: 8 hours @ 43°C (110°F)
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
Storage
After sterilization, devices must remain in sterilization packaging and be
stored in a clean, dry environment.
Skull in Insertion
• Push skull pins into their respective skull clamp locations until fully inserted.
Skull pins must be fully seated so that there are no gaps between the
shoulder of the skull pin and the receptacle into which it has been inserted.
• Remove protective skull pin sleeve before use.
Sterilization for outside United States market.
revacuum Steam Sterilization arameters
Minimum Preconditioning Pulses: 3
Minimum Temperature: 132°C (270°F)
Minimum Exposure Time: 3 minutes
Minimum Dry Time: 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
GapNo Gap
Correct Placement Wrong Placement
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