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Istruzioni per l'uso
Le istruzioni di montaggio che seguono si riferiscono al
fissaggio del Divaricatore Halo alla testiera MAYFIELD
(codice #A-2000). Per il montaggio ad altri modelli di
testiere MAYFIELD (codice #A-1013, A-1014, A-1059,
o A-1108) o alle testiere MAYFIELD radiotrasparenti
(codice #A-1058 o #A-2002) seguire le stesse proce-
dure di montaggio.
NOTA:
Il paziente deve essere posizionato nella
testiera MAYFIELD e deve essere coperto nel modo
usuale. Da questo punto in poi il campo operatorio è
sterile. L'intero processo descritto deve essere esegui-
to usando la tecnica sterile.
1. Posizionare la testiera MAYFIELD sotto il telo chirur-
gico sterile. Fissare le staffe di supporto (codice n.#4-
38-B-1010) sopra il telo sterile intorno ai montanti della
testiera. Le staffe devono essere rivolte verso l'esterno
con la ghiera di bloccaggio in posizione in alto o in
basso. Serrare le staffe girando in senso orario il
pomello di bloccaggio della staffa di supporto della
testiera (Figura 2).
NOTA:
La sfera di compressione deve essere cen-
trata nella ghiera di bloccaggio per accettare l'asta di
supporto Halo (codice n. #4-38-A-1188).
2. Fissare entrambe le aste di supporto all'anello Halo
mettendo la sfera delle aste di supporto nei ricettacoli
delle staffe di montaggio dell'anello. Serrare con le dita
le ghiere ruotando in senso orario (Figura 3).
Figura 3
3. Inserire le aste di supporto (che sono ora collegate
all'anello Halo) nei ricettacoli delle sfere di compres-
sione per la staffa di supporto Halo. Serrare con le dita
le ghiere delle staffe ruotando in senso orario (Figura 4).
4. Con le quattro ghiere serrate soltanto con le dita, il
movimento dei giunti a sfera delle aste di supporto
consentirà di posizionare con precisione l'anello Halo
sopra il campo operatorio. È possibile modificare l'al-
tezza dell'anello sul campo operatorio allentando le
ghiere sulle staffe di supporto per consentire alle aste
di muoversi liberamente. (Figura 5).
Care and Cleaning
After each use, disassemble all components of the system and thoroughly clean using a damp cloth and neutral pH
detergent. Remove all traces of blood and debris and dry completely. The entire BUDDE Halo retractor system
(REF# A-1040) should be steam sterilized before each use.
NOTE:
Do not disassemble retractor arm assembly (REF# 4-38-A-1011). Loosen tension on the retractor arm's
adjustment knob, which will allow for ample separation of the individual ball joints for appropriate cleaning.
Inspection
Carefully inspect all parts after each cleaning to assure all components are in proper working condition. Pay particular
attention to the retractor arm assemblies.
CAUTION:
Components should be returned for repair if wear is noted.
Lubrication
It is extremely important that movable parts be properly lubricated to keep these parts functional. It is recommended
that all components be immersed in a water-soluble lubricant prior to sterilization.
Sterilization
Steam sterilize at 132.2°C high vacuum (2 psia) for 3 minutes. Other time and steam temperature cycles may also be
used. However, the user must validate any deviation from the recommended time and temperature.
Follow the sterilizer manufacturer's instructions for operation and loading of steam autoclave. There must be direct
steam exposure to all surfaces of the implants and instruments.
NOTE:
Allow components to cool to room temperature before use.
Warranty
INTEGRA LIFESCIENCES warrants that each new INTEGRA LIFESCIENCES product is free from defects in material and workmanship under nor-
mal use and service for a period of one (1) year (except as otherwise expressly provided as to accessory items) from the date of delivery by INTE-
GRA LIFESCIENCES to the first purchaser, but not beyond the "Expiration" date stated on any product labeling. MAYFIELD surgical devices are
guaranteed to be free from defects in material and workmanship when used normally for their intended purpose. Any covered product that is
returned to INTEGRA LIFESCIENCES for repair or replacement will be carried out at INTEGRA LIFESCIENCES' sole discretion, at INTEGRA
LIFESCIENCES' expense, subject to the terms of this warranty and applicable agreements. Defective products should be returned promptly, prop-
erly packaged and postage prepaid. Loss or damage in return shipment to INTEGRA LIFESCIENCES shall be at CUSTOMER's risk.
IN NO EVENT SHALL INTEGRA LIFESCIENCES BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES
IN CONNECTION WITH THE ACQUISITION OR USE OF ANY INTEGRA LIFESCIENCES PRODUCT. Further, this warranty shall not apply to,
and INTEGRA LIFESCIENCES shall not be responsible for, any loss arising in connection with the purchase or use of any INTEGRA LIFE-
SCIENCES product which has been repaired by anyone other than an authorized INTEGRA LIFESCIENCES service representative or altered in
any way so as, in INTEGRA LIFESCIENCES' judgment, to affect its stability or reliability, or which has been subject to misuse, negligence or acci-
dent, or which has been used otherwise than in accordance with the instructions furnished by INTEGRA LIFESCIENCES. THIS LIMITED WAR-
RANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AND ALL OTHER OBLIGATIONS OR LIABILI-
TIES ON INTEGRA LIFESCIENCES' PART, AND INTEGRA LIFESCIENCES NEITHER ASSUMES NOR AUTHORIZES ANY REPRESENTATIVE
OR OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH INTEGRA LIFESCIENCES' PRODUCTS.
INTEGRA LIFESCIENCES DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MER-
CHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF QUALITY, OTHER THAN THOSE
EXPRESSLY SET FORTH IN THE PRODUCT LABELING, INCLUDING THE APPLICABLE USER INFORMATION. The foregoing shall not relieve
INTEGRA LIFESCIENCES from strict tort liability, if otherwise applicable under governing law, for damages for personal injury caused by a product
defect that made the product unreasonably dangerous at the time it was sold or placed.
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