Getinge MAQUET Prismalix PRX 8401 A.C.S User manual

Modèle présenté PRX 8401 A.C.S.
Description type PRX 8401 A.C.S.
Description type PRX 8401 A.C.S.
Éclairage opératoire
Surgical light
수술용 조명장치
Notice d'utilisation
User manual
사용자 매뉴얼
PRISMALIX NU FRENKO 0113103 EdG 04/15
FR
EN
KO

2 0113103 Notice d'utilisation / User manual / 사용자 매뉴얼
Éclairage opératoire
Surgical light
수술용 조명장치

Notice d'utilisation / User manual / 사용자 매뉴얼 0113103 3
Éclairage opératoire
Surgical light
수술용 조명장치
Chers utilisateurs,
Nous vous remercions d’avoir choisi
l’éclairage opératoire MAQUET SA
PRISMALIX.
C’est un tout nouveau concept d’éclairage
opératoire basé sur des systèmes
optiques et mécaniques innovants et très
performants.
MAQUET SA a conçu cette nouvelle série
de produits an de garantir le confort de
travail de l’équipe chirurgicale ainsi que
les conditions de sécurité optimales pour
le patient.
Ce nouveau produit est le fruit de notre
contact constant avec les utilisateurs et
de l’expérience de notre bureau d’étude.
Grâceàcesexpériences,PRISMALIX vous
garantit :
- Une dilution exceptionnelle des
ombres.
- Une maniabilité incomparable.
- Un traitement original du volume de
lumière.
An de proter au maximum de tous les
avantages de modularité exceptionnelle
de l’éclairage opératoire PRISMALIX,
nous vous invitons à lire attentivement
cette notice.
Notre réseau reste à votre entière
disposition pour répondre à vos questions
et vous faire découvrir les autres produits
de la gamme MAQUET SA.
MAQUET SA,
LE PARTI PRIS
DE L’EVOLUTION
Dear customer,
Thank you for choosing the MAQUET SA
PRISMALIX surgical light.
PRISMALIX is an entirely new surgical
lighting concept implementing innovative
sophisticated optical and mechanical
systems.
MAQUET SA has designed the prismalix
range to ensure the most comfortable
working conditions for the surgical team and
optimum safety conditions for the patient.
PRISMALIX is the result of MAQUET SA's
on-going contact with our customers and
the preview experience of our engineering
and design team. As a result, PRISMALIX
ensures:
- Superb shadow dilution.
- Easy movement handling.
- Original treatment of the light
volume.
To get the most from the exceptional
features of the PRISMALIX surgical light,
please carefully read this manual.
Don’t hesitate to contact MAQUET SA with
any questions you may have concerning
PRISMALIX or our other products.
MAQUET SA,
A COMMITMENT
TO PROGRESS
고객 에게,
MAQUET SA PRISMALIX 수술용
조명장치의 선택해 주셔서 감사 드립니다.
PRISMALIX는 혁신적이고 정교한 광학 및
기계 시스템을 이용한 완전히 새로운 수술용
조명 개념에 의한 것입니다.
MAQUET SA는 수술 팀에게는 가장 편안한
작업환경을 그리고 환자에게는 최적의
안전환경을 제공하도록 prismalix 레인지를
설계했습니다.
PRISMALIX는, MAQUET SA의 고객과의
실시간 접촉, 및 우리 엔지니어링과 기술
팀의 미래지향적 경험의 결과 물이다.
결과적으로 PRISMALIX는 다음 사항을
보증합니다:
- 탁월한 음영 해상도
- 편리한 이동 취급성
- 광량의 원천적 처리
PRISMALIX 수술용 조명장치의 놀라운
특성을 최대로 이용하기 위해서는 본
매뉴얼을 주의 깊게 읽기를 권고합니다.
PRISMALIX나 우리의 기타 제품에 대하여
의문이 있으면, 즉시 MAQUET SA 에게
연락하기 바랍니다.
MAQUET SA,
진보를 약속합니다.

4 0113103 Notice d'utilisation / User manual / 사용자 매뉴얼
Éclairage opératoire
Surgical light
수술용 조명장치
품질 인증
MAQUET SA 품질시스템 인증서
LNE/G-MED 인증 마크는 수술조명장치의
고안, 제작, 판매, 설치 및 애프터 서비스를
위하여 MAQUET SA사가 자체 개발한 품질
시스템이 국제 규격의 요구사항에 적합하다
는 것을 증명합니다.
- ISO 9001:2000
- NF EN ISO 13485:2004
PRISMALIX 은 다음의 실행 규격을
충족시키도록 설계되었다:
• EN ISO 14971:2000
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
•ENISO14971:2000/A1:2003
•EN60601-1:1990
Medical electrical equipment -
Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
Amendment A13:1996 to EN
60601-1:1990
•EN60601-1-2:2001
Medical electrical equipment -
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests
•EN60601-1-4:1996
Medical electrical equipment -
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Amendment A1:1999 to EN
60601-1-4:1996
•EN60601-1-6:2004
Medical electrical equipment -
Part 1-6: General requirements for safety -
Collateral standard: Usability
•EN60601-2-41:2000
Medical electrical equipment -
Part 2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
이 제품은 다음 보완 기준에 따라 확인을
받았습니다:
CAN/CSA-C22.2 N° 601.1-M90 (R2005) (
캐나다의 경우 국가적 차이 포함)
EN 60601-1:1990+A1 :1993+A2 :1995+A13
:1996, UL 60601-1, 제 1회, 2006-04-26 (
미국의 경우 국가적 차이 포함).
CE 마크
의료기기 관련 1994년 6월 14일자 93/42/
CEE 지침의 요구사항에 부합하는지가 별첨 7
에 따라 평가되었다. 이들 수술 조명은 93/42/
CEE 지침의 별첨 9에 따라 제 1등급에 속한다.
사용 또는 환경이 변경된 경우에
는, MAQUET SA에 연락하여야
제품의 품질을 보증받을 수 있다.
Conformité aux normes
de qualité
Certicationdusystèmequalitéde
MAQUET SA
Le LNE/G-MED certifie que le système
qualité développé par MAQUET SA pour la
conception, la réalisation, la vente, l’instal-
lation et le service après-vente d’éclairages
opératoires est conforme aux exigences des
normes internationales :
- ISO 9001 version 2000
- NF EN ISO 13485 version 2004
L’éclairage opératoire PRISMALIX a été
conçu pour répondre aux normes suivan-
tes:
• EN ISO 14971:2000
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
•ENISO14971:2000/A1:2003
•EN60601-1:1990
Medical electrical equipment -
Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
Amendment A13:1996 to EN
60601-1:1990
•EN60601-1-2:2001
Medical electrical equipment -
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests
•EN60601-1-4:1996
Medical electrical equipment -
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Amendment A1:1999 to EN
60601-1-4:1996
•EN60601-1-6:2004
Medical electrical equipment -
Part 1-6: General requirements for safety -
Collateral standard: Usability
•EN60601-2-41:2000
Medical electrical equipment -
Part 2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
Ce produit a fait l’objet de vérifications
conformément aux normes complémentaires
suivantes : CAN/CSA-C22.2 No. 601.1-M90
(R2005) (comprend les différences natio-
nales pour le Canada), EN 60601-1:1990 +
A1:1993 + A2:1995 + A13:1996, UL 60601-1,
1ère édition, 2006-04-26 (comprend les dif-
férences nationales pour les Etats-Unis).
Marquage CE
La conformité aux exigences de la Direc-
tive 93/42/CEE du 14 juin 1993 relative aux
dispositifs médicaux a été évaluée selon
l'Annexe VII de la Directive. La gamme
d’éclairage opératoire PRISMALIX appartient
à la Classe I selon l'Annexe IX de la Directive
93/42/CEE.
Qualitycompliance
Certification of MAQUET SA quality
system
LNE/G-MED certies that the quality system
created by Maquet SA for the design,
manufacturing, marketing, installation and
customer servicing of its surgical lights meets
the requirements of the following international
standards:
- ISO 9001:2000
- ISO 13485:2004
PRISMALIX is designed to fullll the following
applicable standards:
• EN ISO 14971:2000
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
•ENISO14971:2000/A1:2003
•EN60601-1:1990
Medical electrical equipment -
Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
Amendment A13:1996 to EN
60601-1:1990
•EN60601-1-2:2001
Medical electrical equipment -
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests
•EN60601-1-4:1996
Medical electrical equipment -
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Amendment A1:1999 to EN
60601-1-4:1996
•EN60601-1-6:2004
Medical electrical equipment -
Part 1-6: General requirements for safety -
Collateral standard: Usability
•EN60601-2-41:2000
Medical electrical equipment -
Part 2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
This product was investigated according
to the following additional standards:
CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(includes National Differences for Canada),
EN 60601-1:1990 + A1:1993 + A2:1995
+ A13:1996, UL 60601-1, 1st Edition,
2006-04-26 (includes National Differences
for USA).
CE Marking
Compliance with the requirements ofDirective
93/42/EEC dated of June 14th 1993, relating
to medical devices has been assessed in
accordance with Annex VII of this Directive.
This PRISMALIX Surgical lights range is a
class I device in accordance with Annex IX
of Directive 93/42/EEC.
Afin de garantir toutes les
qualités de nos produits, il
est nécessaire de prévenir
MAQUET SA en cas de chan-
gement d'environnement ou
d'utilisation.
In order to guarantee the quality
of our products, it is necessary
to contact MAQUET SA in
case of use or environment
change.


Notice d'utilisation / User manual / 사용자 매뉴얼 0113103 5
Éclairage opératoire
Surgical light
수술용 조명장치
목 차
품질 인증............................................4
사용된 심볼 ........................................6
경 고 .................................... 7
안전 지침 ................................ 8
PRISMALIX 개념................................11
내용 및 특성 ......................................15
I) 이용
A) 시작 ...........................................19
B) 살균대상 핸들의 기능 및 사용...21
C) 수술용 조명장치 사전배치.........23
D) 수술용 조명장치 조작................25
1) S 및 S.A. 현가장치...................25
2) A.C.S. 현가장치........................25
3) A.C.S. 현가장치 취급...............27
II) 세척 및 유지보수
A) 세척 및 소독 ..............................28
B) 유지보수 ....................................31
1) 예방적 유지보수 적절한
유지보수의 4가지 핵심 .............31
2) 일차 레벨의 유지보수................31
PRISMALIXTM 수술용 조명장치의 일반
특성 ......................................
32
예비부품, 보조부품 ...........................33
전자파 적합성 선언 ................... 35
고장진단해결.....................................48
부 록
검사 시트...........................................55
SOMMAIRE CONTENTS
EXIGENCES QUALITÉ ........................ 4
SYMBOLES UTILISÉS......................... 6
AVERTISSEMENTS ............................. 7
CONSIGNES DE SECURITE............... 8
LE CONCEPT PRISMALIX ................. 11
DESCRIPTIFS ET
CARACTÉRISTIQUES........................ 15
I) UTILISATION
A) MISE EN MARCHE........................ 19
B) FONCTION ET UTILISATION
DE LA POIGNÉE
STÉRILISABLE............................. 21
C) PRÉPOSITIONNEMENT
DE L’ÉCLAIRAGE......................... 23
D) MANIPULATION DES ÉCLAIRAGES
25
1) Les suspensions S et S.A............. 25
2) Les suspensions A.C.S................. 25
3) Décalage et manipulation
des suspensions A.C.S................. 27
II) ENTRETIEN ET
MAINTENANCE
A) NETTOYAGE ET
DÉSINFECTION........................... 28
B) MAINTENANCE............................ 31
1) Maintenance préventive :
les 4 clés de la
maintenance ................................. 31
2) Maintenance
de premier niveau......................... 31
CARACTERISTIQUES GENERALES. 32
PIECES DE RECHANGE,
ACCESSOIRES................................... 33
DECLARATION CEM .......................... 35
ANOMALIES ET PANNES DE
FONCTIONNEMENT........................... 44
ANNEXES
FICHE DE CONTROLE....................... 51
QUALITY COMPLIENCE ..................... 4
SYMBOLS USED ................................. 6
WARNINGS.......................................... 7
INSTRUCTIONS FOR SAFE USE ....... 8
THE PRISMALIX CONCEPT............... 11
DESCRIPTION AND
CHARACTERISTICS........................... 15
I) UTILIZATION
A) STARTUP....................................... 19
B) FUNCTION AND USE
OF STERILIZABLE
HANDLE ....................................... 21
C) PREPOSITIONING
THE SURGICAL LIGHT................ 23
D) MANEVERING THE SURGICAL
LIGHT ........................................... 25
1) S and S.A. suspensions................ 25
2) A.C.S. suspensions ...................... 25
3) Handling the A.C.S.
suspensions................................. 27
II) CLEANING
AND MAINTENANCE
A) CLEANING AND
DISINFECTION ............................ 28
B) MAINTENANCE............................ 31
1) Preventive maintenance
Four keys to proper
maintenance ................................. 31
2) First level
maintenance ................................. 31
GENERAL CHARACTERISTICS ........ 32
SPARE PARTS,
ACCESSORIES................................... 33
EMC DECLARATION .......................... 35
TROUBLESHOOTING ........................ 46
ANNEXES
INSPECTION SHEET.......................... 53