Fisso 6646 Series User manual

Instruction for use
Arm support with quick central fixation
Gebrauchsanweisung
Armhalter mit Schnellfixierung
Mode d’emploi
Support de bras avec fixation rapide
Istruzioni per l'uso
Supporto del braccio con fissaggio rapido
Instrucciones de uso
Soporte de brazo con fijación rápida
Manual de instrução
Suporte para braço com fixação rápida
Gebruiksaanwijzing
Armsteun met snelfixatie
Brugsanvisning
Armholder med hurtigfiksering
Käyttöohje
Käsivarsituki pikakiinnityksellä
Bruksanvisning
Armholder med hurtigfeste
Bruksanvisning
Armhållare med snabbfixering
Instrukcja obsługi
Podpórka pod r
k
z układem szybkiego mocowania
!"
EN
DE
FR
IT
ES
PT
NL
DK
FI
NO
S
E
PL
CN
JP

2
GM446-V7 / 18.12.2017
English
INTRODUCTION................................................................................................................................... 16
G
ENERAL
I
NFORMATION
....................................................................................................................... 16
S
YMBOLS USED
................................................................................................................................... 16
D
EFINITIONS
(
ACCORDING TO THE NORM
EN
ISO
17664) ..................................................................... 17
INTENDED USE ................................................................................................................................... 17
PRODUCT DESCRIPTION .................................................................................................................. 18
INSTALLATION AND USE ................................................................................................................... 18
F
IRST CHECK
....................................................................................................................................... 18
W
ARRANTY
......................................................................................................................................... 18
A
SSEMBLY
........................................................................................................................................... 19
D
ISASSEMBLY
...................................................................................................................................... 19
H
ANDLING OF THE ARTICULATED ARM
................................................................................................... 19
H
ANDLING OF
A
RM SUPPORTS
.............................................................................................................. 21
PROCESSING (CLEANING AND DISINFECTION)............................................................................. 21
P
RE
-
TREATMENT
................................................................................................................................. 21
M
ANUAL CLEANING AND DISINFECTION BY WIPING
................................................................................. 22
CONTROL............................................................................................................................................. 23
PACKAGING AND STORAGE ............................................................................................................. 23
MAINTENANCE.................................................................................................................................... 23
MATERIAL RESISTANCE.................................................................................................................... 23
REUSABILITY ...................................................................................................................................... 23
TECHNICAL DATA............................................................................................................................... 24
EN

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GM446-V7 / 18.12.2017
Deutsch
EINFÜHRUNG ...................................................................................................................................... 25
A
LLGEMEINE
I
NFORMATIONEN
.............................................................................................................. 25
V
ERWENDETE
S
YMBOLE
...................................................................................................................... 25
B
EGRIFFE
(
GEMÄß
N
ORM
EN
ISO
17664) ........................................................................................... 26
BESTIMMUNGSGEMÄßE VERWENDUNG ........................................................................................ 26
PRODUKTBESCHREIBUNG ............................................................................................................... 27
INBETRIEBNAHME UND BEDIENUNG .............................................................................................. 27
E
INGANGSKONTROLLE
......................................................................................................................... 27
G
EWÄHRLEISTUNG
............................................................................................................................... 27
M
ONTAGE
............................................................................................................................................ 28
D
EMONTAGE
........................................................................................................................................ 28
B
EDIENUNG DES
G
ELENKARMES
........................................................................................................... 29
B
EDIENUNG DES
A
RMPOLSTERS
........................................................................................................... 30
AUFBEREITUNG (REINIGUNG UND DESINFEKTION).....................................................................30
V
ORBEHANDLUNG
................................................................................................................................ 30
M
ANUELLE
R
EINIGUNG UND
D
ESINFEKTION DURCH
W
ISCHEN
............................................................... 30
KONTROLLE........................................................................................................................................ 32
VERPACKUNG UND LAGERUNG ...................................................................................................... 32
WARTUNG............................................................................................................................................ 32
MATERIALBESTÄNDIGKEIT............................................................................................................... 32
WIEDERVERWENDBARKEIT ............................................................................................................. 32
TECHNISCHE DATEN.......................................................................................................................... 33
DE

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GM446-V7 / 18.12.2017
Français
INTRODUCTION................................................................................................................................... 34
I
NFORMATION GÉNÉRALE
...................................................................................................................... 34
S
YMBOLES UTILISES
............................................................................................................................. 34
D
EFINITIONS
(
SELON LA NORME
EN
ISO
17664).................................................................................. 35
UTILISATION CONFORME A LA DESTINATION ...............................................................................35
DESCRIPTION DE PRODUIT .............................................................................................................. 36
MISE EN SERVICE ET UTILISATION..................................................................................................36
C
ONTROLE INITIAL
............................................................................................................................... 36
G
ARANTIE
............................................................................................................................................ 36
M
ONTAGE
............................................................................................................................................ 37
D
EMONTAGE
........................................................................................................................................ 37
M
ANIPULATION DU BRAS ARTICULE
....................................................................................................... 37
M
ANIPULATION DU APPUIE
-
BRAS
........................................................................................................... 39
TRAITEMENT PREPARATOIRE (NETTOYAGE ET DESINFECTION)............................................... 39
P
RÉTRAITEMENT
.................................................................................................................................. 39
N
ETTOYAGE ET DESINFECTION MANUELS EN ESSUYANT LE PRODUIT
...................................................... 40
CONTROLE .......................................................................................................................................... 41
EMBALLAGE ET STOCKAGE............................................................................................................. 41
ENTRETIEN.......................................................................................................................................... 41
RESISTANCE DES MATERIAUX.........................................................................................................41
POSSIBILITÉS DE RÉUTILISATION................................................................................................... 42
DONNEES TECHNIQUES.................................................................................................................... 42
FR

5
GM446-V7 / 18.12.2017
Italiano
INTRODUZIONE................................................................................................................................... 43
I
NFORMAZIONI GENERALI
...................................................................................................................... 43
S
IMBOLI UTILIZZATI
............................................................................................................................... 43
D
EFINIZIONI
(
SECONDO LA NORMA
EN
ISO
17664)............................................................................... 44
IMPIEGO PREVISTO............................................................................................................................ 44
DESCRIZIONE DEL PRODOTTO........................................................................................................ 45
MESSA IN FUNZIONE E UTILIZZO..................................................................................................... 45
C
ONTROLLO INIZIALE
............................................................................................................................ 45
G
ARANZIA
............................................................................................................................................ 45
M
ONTAGGIO
........................................................................................................................................ 46
S
MONTAGGIO
...................................................................................................................................... 46
I
MPIEGO DEL BRACCIO ARTICOLATO
...................................................................................................... 46
I
MPIEGO DEGLI APPOGGI PER IL BRACCIO
.............................................................................................. 48
TRATTAMENTO (PULIZIA E DISINFEZIONE) .................................................................................... 48
P
RE
-
TRATTAMENTO
............................................................................................................................. 48
P
ULIZIA MANUALE E DISINFEZIONE MEDIANTE STROFINAMENTO
.............................................................. 49
CONTROLLO ....................................................................................................................................... 50
IMBALLAGGIO E CONSERVAZIONE................................................................................................. 50
MANUTENZIONE ................................................................................................................................. 50
RESISTENZA DEI MATERIALI ............................................................................................................ 51
RIUTILIZZABILITÀ ............................................................................................................................... 51
DATI TECNICI....................................................................................................................................... 51
IT

6
GM446-V7 / 18.12.2017
Español
INTRODUCCIÓN .................................................................................................................................. 52
I
NFORMACIONES GENERALES
............................................................................................................... 52
S
ÍMBOLOS UTILIZADOS
......................................................................................................................... 52
D
EFINICIONES
(
SEGÚN LA NORMA
EN
ISO
17664)................................................................................ 53
USO PREVISTO ................................................................................................................................... 53
DESCRIPCIÓN DEL PRODUCTO ....................................................................................................... 54
PUESTA EN SERVICIO Y MANEJO.................................................................................................... 54
C
ONTROL A LA LLEGADA
....................................................................................................................... 54
G
ARANTÍA
............................................................................................................................................ 54
M
ONTAJE
............................................................................................................................................. 55
D
ESMONTAJE
....................................................................................................................................... 55
M
ANEJO DEL BRAZO ARTICULADO
......................................................................................................... 55
M
ANEJO DEL ACOLCHADO PARA EL BRAZO
............................................................................................ 57
TRATAMIENTO (LIMPIEZA Y DESINFECCIÓN) ................................................................................ 57
T
RATAMIENTO PREVIO
.......................................................................................................................... 57
L
IMPIEZA Y DESINFECCIÓN MANUALES FROTANDO
................................................................................. 57
CONTROL............................................................................................................................................. 58
EMBALAJE Y ALMACENAMIENTO .................................................................................................... 59
MANTENIMIENTO ................................................................................................................................ 59
RESISTENCIA DEL MATERIAL........................................................................................................... 59
REUTILIZABILIDAD ............................................................................................................................. 59
DATOS TÉCNICOS .............................................................................................................................. 60
ES

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GM446-V7 / 18.12.2017
Português
INTRODUÇÃO...................................................................................................................................... 61
I
NFORMAÇÕES GERAIS
......................................................................................................................... 61
S
ÍMBOLOS UTILIZADOS
......................................................................................................................... 61
T
ERMINOLOGIA
(
CONFORME A NORMA
EN
ISO
17664) ......................................................................... 62
UTILIZAÇÃO CONFORME A FINALIDADE ........................................................................................ 62
DESCRIÇÃO DO PRODUTO ...............................................................................................................63
COLOCAÇÃO EM FUNCIONAMENTO E FUNCIONAMENTO........................................................... 63
C
ONTROLO AQUANDO DA ENTREGA
...................................................................................................... 63
G
ARANTIA
............................................................................................................................................ 63
M
ONTAGEM
......................................................................................................................................... 64
D
ESMONTAGEM
................................................................................................................................... 64
O
PERAÇÃO DO BRAÇO ARTICULADO
...................................................................................................... 64
U
TILIZAÇÃO DA ALMOFADA DO BRAÇO
................................................................................................... 66
PREPARAÇÃO (LIMPEZA E DESINFEÇÃO)...................................................................................... 66
P
RÉ
-
TRATAMENTO
............................................................................................................................... 66
L
IMPEZA E DESINFEÇÃO MANUAIS COM UM PANO
................................................................................... 66
CONTROLO.......................................................................................................................................... 68
EMBALAGEM E ARMAZENAMENTO ................................................................................................. 68
MANUTENÇÃO .................................................................................................................................... 68
RESISTÊNCIA DO MATERIAL ............................................................................................................ 68
REUTILIZAÇÃO.................................................................................................................................... 68
DADOS TÉCNICOS.............................................................................................................................. 69
PT

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GM446-V7 / 18.12.2017
Nederlands
INLEIDING ............................................................................................................................................ 70
A
LGEMENE INFORMATIE
....................................................................................................................... 70
G
EBRUIKTE SYMBOLEN
........................................................................................................................ 70
B
EGRIPPEN
(
CONFORM
EN
ISO
17664) ............................................................................................... 71
BEOOGD GEBRUIK............................................................................................................................. 71
PRODUCTBESCHRIJVING ................................................................................................................. 72
INBEDRIJFSTELLING EN BEDIENING .............................................................................................. 72
I
NGANGSCONTROLE
............................................................................................................................. 72
G
ARANTIE
............................................................................................................................................ 72
M
ONTAGE
............................................................................................................................................ 73
D
EMONTAGE
........................................................................................................................................ 73
B
EDIENING VAN DE SCHARNIERARM
...................................................................................................... 73
B
EDIENING VAN HET ARMKUSSEN
......................................................................................................... 75
VOORBEREIDING (REINIGING EN DESINFECTIE) .......................................................................... 75
V
OORBEHANDELING
............................................................................................................................. 75
H
ANDMATIGE REINIGING EN DESINFECTIE DOOR WISSEN
....................................................................... 75
CONTROLE .......................................................................................................................................... 76
VERPAKKING EN OPSLAG ................................................................................................................ 77
ONDERHOUD....................................................................................................................................... 77
MATERIAALBESTENDIGHEID............................................................................................................ 77
HERBRUIKBAARHEID ........................................................................................................................ 77
TECHNISCHE GEGEVENS.................................................................................................................. 78
NL

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GM446-V7 / 18.12.2017
Dansk
INDLEDNING........................................................................................................................................ 79
G
ENEREL INFORMATION
....................................................................................................................... 79
A
NVENDTE SYMBOLER
.......................................................................................................................... 79
B
EGREBER
(
IHT
.
STANDARD
EN
ISO
17664)......................................................................................... 80
FORSKRIFTSMÆSSIG ANVENDELSE .............................................................................................. 80
PRODUKTBESKRIVELSE................................................................................................................... 81
IBRUGTAGNING OG BETJENING...................................................................................................... 81
K
ONTROL VED MODTAGELSE
................................................................................................................ 81
G
ARANTI
.............................................................................................................................................. 81
M
ONTERING
......................................................................................................................................... 82
A
FMONTERING
..................................................................................................................................... 82
B
ETJENING AF LEDARM
........................................................................................................................ 82
B
ETJENING AF ARMPUDE
...................................................................................................................... 84
BEHANDLING (RENGØRING OG DESINFICERING) ........................................................................84
F
ORBEHANDLING
................................................................................................................................. 84
M
ANUEL RENGØRING OG DESINFICERING VED AFTØRRING
..................................................................... 84
KONTROL............................................................................................................................................. 85
EMBALLERING OG OPBEVARING .................................................................................................... 86
VEDLIGEHOLDELSE........................................................................................................................... 86
MATERIALEBESTANDIGHED............................................................................................................. 86
GENANVENDELIGHED ....................................................................................................................... 86
TEKNISKE DATA ................................................................................................................................. 87
DK

10
GM446-V7 / 18.12.2017
Suomi
JOHDANTO .......................................................................................................................................... 88
Y
LEISTÄ
............................................................................................................................................... 88
K
ÄYTETYT SYMBOLIT
............................................................................................................................ 88
K
ÄSITTEET
(EN
ISO
17664
-
NORMIN MUKAISESTI
)................................................................................ 89
MÄÄRÄYSTENMUKAINEN KÄYTTÖ.................................................................................................. 89
TUOTTEEN KUVAUS........................................................................................................................... 90
KÄYTTÖÖNOTTO JA KÄYTTÖ........................................................................................................... 90
V
ASTAANOTTOTARKASTUS
................................................................................................................... 90
T
AKUU
................................................................................................................................................. 90
A
SENNUS
............................................................................................................................................ 91
P
URKAMINEN
....................................................................................................................................... 91
N
IVELVARREN KÄYTTÖ
......................................................................................................................... 91
K
ÄSIVARSIPEHMUSTEEN KÄYTTÖ
.......................................................................................................... 93
VALMISTELU (PUHDISTAMINEN JA DESINFIOINTI)........................................................................93
E
SIKÄSITTELY
...................................................................................................................................... 93
P
UHDISTAMINEN KÄSIN JA DESINFIOINTI PYYHKIMÄLLÄ
........................................................................... 93
TARKASTUS ........................................................................................................................................ 94
PAKKAAMINEN JA VARASTOINTI ..................................................................................................... 95
HUOLTO ............................................................................................................................................... 95
MATERIAALIN KESTÄVYYS ............................................................................................................... 95
UUDELLEENKÄYTETTÄVYYS ........................................................................................................... 95
TEKNISET TIEDOT .............................................................................................................................. 96
FI

11
GM446-V7 / 18.12.2017
Norsk
INNLEDNING........................................................................................................................................ 97
G
ENERELL INFORMASJON
..................................................................................................................... 97
S
YMBOLER SOM BRUKES
...................................................................................................................... 97
B
EGREPER
(
IHT
.
NORSK STANDARD
NS-EN
ISO
17664)....................................................................... 98
RIKTIG BRUK....................................................................................................................................... 98
PRODUKTBESKRIVELSE................................................................................................................... 99
BRUK OG BETJENING........................................................................................................................ 99
M
OTTAKSKONTROLL
............................................................................................................................. 99
G
ARANTI
.............................................................................................................................................. 99
M
ONTERING
....................................................................................................................................... 100
D
EMONTERING
................................................................................................................................... 100
B
ETJENE LEDDARMEN
........................................................................................................................ 100
B
ETJENE ARMPOLSTRINGEN
............................................................................................................... 102
KLARGJØRING (RENGJØRING OG DESINFISERING) .................................................................. 102
F
ORBEHANDLING
............................................................................................................................... 102
M
ANUELL RENGJØRING OG DESINFISERING VED AVTØRKING
................................................................ 102
KONTROLL ........................................................................................................................................ 103
EMBALLERING OG OPPBEVARING................................................................................................ 104
SERVICE............................................................................................................................................. 104
MATERIALBESTANDIGHET.............................................................................................................. 104
GJENBRUKBARHET ......................................................................................................................... 104
TEKNISKE DATA ............................................................................................................................... 105
NO

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GM446-V7 / 18.12.2017
Svenska
INLEDNING ........................................................................................................................................ 106
A
LLMÄN INFORMATION
....................................................................................................................... 106
T
ILLÄMPADE SYMBOLER
..................................................................................................................... 106
B
EGREPP
(
ENLIGT NORM
EN
ISO
17664)........................................................................................... 107
AVSEDD ANVÄNDNING .................................................................................................................... 107
PRODUKTBESKRIVNING ................................................................................................................. 108
ANVÄNDNING OCH HANTERING..................................................................................................... 108
I
NGÅNGSKONTROLL
............................................................................................................................ 108
G
ARANTI
............................................................................................................................................ 108
M
ONTERING
....................................................................................................................................... 109
D
EMONTERING
................................................................................................................................... 109
L
EDARMENS HANTERING
.................................................................................................................... 109
D
YNANS HANTERING
.......................................................................................................................... 111
FÖRBEDELSER (RENGÖRING OCH DESINFICERING)................................................................. 111
F
ÖRBEHANDLING
............................................................................................................................... 111
M
ANUELL RENGÖRING OCH DESINFICERING MED TORKNING
................................................................. 111
KONTROLL ........................................................................................................................................ 112
FÖRPACKNING OCH FÖRVARING.................................................................................................. 113
UNDERHÅLL...................................................................................................................................... 113
MATERIALBESTÄNDIGHET.............................................................................................................. 113
ÅTERANVÄNDNING .......................................................................................................................... 113
TEKNISKA DATA ............................................................................................................................... 114
S
E

13
GM446-V7 / 18.12.2017
Polski
WST
#
P................................................................................................................................................ 115
I
NFORMACJE OGÓLNE
........................................................................................................................ 115
Z
ASTOSOWANE SYMBOLE
................................................................................................................... 115
P
OJ
$
CIA
(
ZGODNIE Z
NORM
%
EN
ISO
17664)..................................................................................... 116
ZASTOSOWANIE ZGODNE Z PRZEZNACZENIEM .........................................................................116
OPIS PRODUKTU .............................................................................................................................. 117
ROZRUCH I OBSŁUGA ..................................................................................................................... 117
K
ONTROLA WEJ
&
CIOWA
..................................................................................................................... 117
R
$
KOJMIA
.......................................................................................................................................... 117
M
ONTA
'
............................................................................................................................................ 118
D
EMONTA
'
........................................................................................................................................ 118
O
BSŁUGA RAMIENIA PRZEGUBOWEGO
................................................................................................. 118
O
BSŁUGA PODUSZKI PODPÓRKI
.......................................................................................................... 119
PRZYGOTOWANIE (CZYSZCZENIE I DEZYNFEKCJA) .................................................................. 120
P
ROCEDURA WST
$
PNA
...................................................................................................................... 120
C
ZYSZCZENIE R
$
CZNE I
DEZYNFEKCJA POPRZEZ PRZECIERANIE
.......................................................... 120
KONTROLA........................................................................................................................................ 121
OPAKOWANIE I PRZECHOWYWANIE............................................................................................. 122
KONSERWACJA................................................................................................................................ 122
WYTRZYMAŁO
()
MATERIAŁU........................................................................................................ 122
MO
*
LIWO
()
PONOWNEGO ZASTOSOWANIA.............................................................................. 122
DANE TECHNICZNE.......................................................................................................................... 123
PL

14
GM446-V7 / 18.12.2017
+,
-.
..................................................................................................................................................... 124
/012
........................................................................................................................................... 124
345678
................................................................................................................................... 124
9:;<=
EN
ISO
17664
7>?
.................................................................................................... 125
@ABCD
.......................................................................................................................................... 125
EFGH
.............................................................................................................................................. 126
IJCDKLM
................................................................................................................................... 126
NOPQ
........................................................................................................................................... 126
RS
.................................................................................................................................................. 126
TU
.................................................................................................................................................. 127
VW
.................................................................................................................................................. 127
XYZ6[\
................................................................................................................................... 128
]Z^_6[\
................................................................................................................................ 129
`abcdKefg
........................................................................................................................... 129
hij
.............................................................................................................................................. 130
klmnop]qrstuv
.......................................................................................................... 130
wx
..................................................................................................................................................... 131
yzK{|
.......................................................................................................................................... 131
}~
..................................................................................................................................................... 131
.......................................................................................................................................... 132
CD
.......................................................................................................................................... 132
.............................................................................................................................................. 132
CN

15
GM446-V7 / 18.12.2017
................................................................................................................................................... 133
........................................................................................................................................... 133
................................................................................................................... 134
¡
EN
ISO
17664
¢£¤¥¦
........................................................................................................... 134
§¨©ª«¬®¯
........................................................................................................................... 135
°±²³
.............................................................................................................................................. 135
¬´µ¬®¯
............................................................................................................................. 136
¶·¸¹
........................................................................................................................................... 136
º»
.................................................................................................................................................. 136
¼½¾¿
............................................................................................................................................ 136
ÀÁ
.................................................................................................................................................. 137
ÂÃÄÅÆÇÈÉ
............................................................................................................................... 137
ÄÅÆÊËÌÇÈÉ
............................................................................................................................... 138
ÍÎÏÐÑÒµÓÔÕ
............................................................................................................................. 138
Öר
.............................................................................................................................................. 139
Ù¢ÚÛÜÝÞßàá
...................................................................................................................... 139
âã
..................................................................................................................................................... 140
ä嵿ç
........................................................................................................................................... 140
æèâã
.............................................................................................................................................. 140
éêëìíîïðñ
................................................................................................................................. 141
òóñ
.............................................................................................................................................. 141
êôõöí÷øù
...................................................................................................................................... 141
JP

16
GM446-V7 / 18.12.2017
Introduction
Thank you for buying our product.
You have chosen a high quality Swiss product. We are confident that this product will meet your expectations.
General Information
Please read this instruction for use carefully and keep it close to the product. Improper handling can cause harm
to the patient or damage the products. Use universal precautions when handling contaminated or biohazardous
components / materials.
Our delivery and mailing address is:
Baitella AG
Thurgauerstrasse 70
CH-8050 Zurich
Switzerland
Phone: +41 44 305 80 00
Fax: +41 44 305 80 05
E-Mail: info@baitella.com
Internet: www.fisso.com
Regarding the medical product, the distributor is responsible for the following, among other things:
• Product approvals / registration / traceability
• Compliance with all relevant laws and regulations
Copyrights
All rights reserved. Duplication, adaptation, or translation, of any part of this document, without previous written
authorization by Baitella AG is prohibited, except within the framework of the copyright regulations.
Reserved rights to changes
Baitella AG reserves the right to make changes without notice in design, specifications and models and
assumes no liability for the correctness and completeness of the content of the Instructions for Use.
Symbols used
Symbol Definition Danger Consequence
DANGER!
Immediate danger for people Death or serious injuries
WARNING! Possible danger for people or
objects Health damages or severe
material damages
ATTENTION! Possible danger to objects Material damages
EN

17
GM446-V7 / 18.12.2017
Symbol Description
Symbol for products that are put into use according to the directive 93/42 EEC
NOTE
Additional support or useful information
See instructions for use
Manufacturer
Maximal carrying capacity of the articulated arm during intended use
The articulated arm must not be sprayed directly with liquid or immersed in liquids.
The central handle of the articulated arm must be tightened during cleaning /
disinfection.
Definitions (according to the norm EN ISO 17664)
Cleaning
Removal of contamination from an object needed for further processing
Disinfection
Process used to reduce the number of viable microorganisms on a product to a previously specified level
Manual cleaning
Cleaning without using a cleaning/disinfection apparatus
Intended Use
The Arm Support is used to position the patient arm during anaesthesia as well as during the initiation and
reversal phase of anaesthesia. It must only be used by trained medical personnel capable of judging and
controlling any danger to patients. If not the case, the user assumes all responsibility.
DANGER!
Unauthorized changes or modifications to the FISSO holding system are prohibited for
safety reasons.
EN

18
GM446-V7 / 18.12.2017
DANGER!
All FISSO components are designed for optimal performance when used together with the
FISSO holding system. If a component (e.g. a base) from another manufacturer is used,
the user takes full responsibility.
DANGER!
The product will be delivered non sterile and is non-sterilisable. Prior to the initial and
each following use, the product has to be cleaned and disinfected as well as checked for
visual irregularities and malfunctioning according to the indications given in this manual.
Guideline for medical devices (conformity declaration)
This product corresponds to the guideline 93/42/EEC and may solely be used for medical
applications.
Special care should be taken when these products are used together with high-frequency applications.
Contacts between the product and the high-frequency device must be avoided.
Product description
Arm support lateral
Art. # 6646.XX Arm support lateral
Art. # 4646.XX Arm support vertical
Art. # 6656.XX Arm support vertical
Art. # 4670.XX
Pad VE 450 mm VE/PUR 450 mm VE 450 mm VE/PUR 450 mm
Articulated Arm 6600-46 4600-46 6600-56 4600-70
Column
with stop lid - - ∅18 x 215 mm ∅16 x 215 mm
Base component Rail clamping base
Fisso Rail clamping base Radial setting clamp
Fisso (partly
optional)
Radial setting clamp
Fisso (partly
optional)
Fastening straps optional optional optional optional
VE = anatomically shaped visco-elastic pad
PUR = integral foam pad made of Polyurethane
Before delivery to the clients, the components are rigidly threaded to the articulated arm and additionally
fastened with glue.
Installation and use
First check
Check the product immediately after receipt for eventual transport damages and for completeness. Complaints
can only be considered if the manufacturer, distributor or carrier is immediately notified through damage
protocol.
Warranty
The manufacturer assumes warranty for materials and manufacturing defects as well as proper functioning of
FISSO holding systems for two years from date of purchase.
Not covered by the warranty are normal wear, components with a shorter life time (e.g. arm pads), the
consequences of inappropriate handling, combinations with external products, or damage caused by the user.
Other or further claims, in particular any claims for damage are excluded. The warranty applies only if the
Baitella AG repair service is used. Please see also the General Delivery Conditions.
The warranty is limited to the express written warranty in this document.
EN

19
GM446-V7 / 18.12.2017
Assembly
The Arm support can be easily mounted to the surgical table without additional tools. All handling should be
done with as little force as possible and as much force as necessary!
Arm support lateral:
Attach the base to the side rail of the surgical table and secure it by turning the
fastening screw (Pos. 1) from below clockwise. Please note that the top hook (Pos.
2) grasps behind the rail. Check if the base is fixed securely and firmly on the side
rail.
Arm support vertical:
Mount the base in the same way described for arm support lateral, see above.
Remove the stop lid (Pos. 3) and insert the column (Pos. 4) into the opening of the
radial setting clamp. Fix it with the fastening handle (Pos. 5). Mount the stop lid.
Check if the column is fixed securely and firmly into the base.
The column can be adjusted for height and inclination.
WARNING!
Risk of injury and damage to property
If the base / column is not correctly tightened, it may become loose and may cause injuries
to the patient.
The rail clamping base and if applicable column must be tightened properly.
WARNING!
Close the gear coupling in such a manner, that the teeth grasp into each other and that
they do not stand on each other.
Disassembly
The disassembly of the set can be performed also without additional tools and occurs in the reverse order of the
assembly:
Hold the Arm support with one hand and loosen with the other hand the fastening screw of the rail clamping
base. Remove the base from the rail of the surgical table.
Handling of the articulated arm
1
Hold the articulated arm with one hand in the anterior segment (A) and
manipulate the central clamping handle (Z) with the other hand
2
To release turn the central handle (Z) counter clockwise (B) as far as
necessary
3
Move the articulated arm into the desired position
4
To secure, turn the central handle (Z) clockwise (C)
5
Check that the articulated arm is fixed firmly and is functioning properly
A
EN
Pos. 2
Pos. 2
Pos. 1
Pos. 1
P
os. 5
P
os. 4
P
os. 3

20
GM446-V7 / 18.12.2017
DANGER!
Danger of serious injuries
The articulated arm can move unintentionally if the central clamping is released.
Always hold the arm board with one hand and manipulate the central
clamping
device (Z) with the other hand.
DANGER!
Danger of serious injuries
If the articulated arm is not tightened properly it can become loose and move,
potentially causing injuries.
The articulated arm must be tightened properly.
DANGER!
Danger of serious injuries
A damaged product can cause injuries.
Use only products in proper condition and check functionality.
DANGER!
Danger of life or serious injuries
Threat through inappropriate handling
Follow instructions for use of arm support and surgical table
WARNING!
Risk of injury and damage to property
Please check the risk of collision during patient transport with exposed arm
support.
If possible position the arm support parallel to the surgical table.
WARNING!
Risk of injury and damage to property
The arm support lateral 4646.XX has a maximal carrying capacity of 6 kg during
intended use, the arm support lateral 6646.XX one of 10 kg, the arm support
vertical 6656.XX has a maximal carrying capacity of 6 kg and the arm support
vertical 4670.XX has a maximal carrying capacity of 4 kg.
The maximal carrying capacity must not be exceeded.
EN
This manual suits for next models
3
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