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 rękę z układem szybkiego mocowania
使用说明书
带快速固定装置的手臂支架
取扱説明書
クイックロック付きアームサポート
EN
DE
FR
IT
ES
PT
NL
DA
FI
NO
SV
PL
ZH
JA

2
English
INTRODUCTION.............................................................................................................................................................. 16
GENERAL INFORMATION........................................................................................................................................................... 16
SYMBOLS USED....................................................................................................................................................................... 16
INTENDED USE ............................................................................................................................................................... 18
PRODUCT DESCRIPTION ................................................................................................................................................ 18
INSTALLATION AND USE................................................................................................................................................. 19
FIRST CHECK........................................................................................................................................................................... 19
WARRANTY............................................................................................................................................................................ 19
ASSEMBLY ............................................................................................................................................................................. 19
DISASSEMBLY ......................................................................................................................................................................... 20
HANDLING OF THE ARTICULATED ARM ......................................................................................................................................... 20
HANDLING OF ARM SUPPORTS................................................................................................................................................... 21
PROCESSING (CLEANING AND DISINFECTION) ................................................................................................................ 21
PRE-TREATMENT..................................................................................................................................................................... 21
MANUAL CLEANING AND DISINFECTION BY WIPING......................................................................................................................... 22
CONTROL ....................................................................................................................................................................... 23
PACKAGING AND STORAGE............................................................................................................................................ 23
MAINTENANCE............................................................................................................................................................... 23
MATERIAL RESISTANCE .................................................................................................................................................. 23
REUSABILITY................................................................................................................................................................... 24
OBLIGATION TO NOTIFY................................................................................................................................................. 24
DISPOSAL ....................................................................................................................................................................... 24
TECHNICAL DATA ........................................................................................................................................................... 24
EN

3
Deutsch
EINFÜHRUNG ................................................................................................................................................................. 25
ALLGEMEINE INFORMATIONEN................................................................................................................................................... 25
VERWENDETE SYMBOLE ........................................................................................................................................................... 25
BESTIMMUNGSGEMÄßE VERWENDUNG....................................................................................................................................... 27
PRODUKTBESCHREIBUNG .............................................................................................................................................. 27
INBETRIEBNAHME UND BEDIENUNG.............................................................................................................................. 28
EINGANGSKONTROLLE.............................................................................................................................................................. 28
GEWÄHRLEISTUNG .................................................................................................................................................................. 28
MONTAGE............................................................................................................................................................................. 28
DEMONTAGE.......................................................................................................................................................................... 29
BEDIENUNG DES GELENKARMES................................................................................................................................................. 29
BEDIENUNG DES ARMPOLSTERS ................................................................................................................................................. 30
AUFBEREITUNG (REINIGUNG UND DESINFEKTION) ........................................................................................................ 30
VORBEHANDLUNG................................................................................................................................................................... 31
MANUELLE REINIGUNG UND DESINFEKTION DURCH WISCHEN ......................................................................................................... 31
KONTROLLE.................................................................................................................................................................... 32
VERPACKUNG UND LAGERUNG...................................................................................................................................... 32
WARTUNG...................................................................................................................................................................... 33
MATERIALBESTÄNDIGKEIT ............................................................................................................................................. 33
WIEDERVERWENDBARKEIT ............................................................................................................................................ 33
MELDEPFLICHT ............................................................................................................................................................... 33
ENTSORGUNG ................................................................................................................................................................ 33
TECHNISCHE DATEN ....................................................................................................................................................... 34
DE

4
Français
INTRODUCTION.............................................................................................................................................................. 35
INFORMATION GÉNÉRALE.......................................................................................................................................................... 35
SYMBOLES UTILISES ................................................................................................................................................................. 35
UTILISATION CONFORME A LA DESTINATION................................................................................................................. 37
DESCRIPTION DE PRODUIT ............................................................................................................................................. 37
MISE EN SERVICE ET UTILISATION .................................................................................................................................. 38
CONTROLE INITIAL................................................................................................................................................................... 38
GARANTIE.............................................................................................................................................................................. 38
MONTAGE............................................................................................................................................................................. 38
DEMONTAGE.......................................................................................................................................................................... 39
MANIPULATION DU BRAS ARTICULE............................................................................................................................................. 39
MANIPULATION DU APPUIE-BRAS ............................................................................................................................................... 40
TRAITEMENT PREPARATOIRE (NETTOYAGE ET DESINFECTION) ...................................................................................... 40
PRÉTRAITEMENT ..................................................................................................................................................................... 41
NETTOYAGE ET DESINFECTION MANUELS EN ESSUYANT LE PRODUIT ................................................................................................... 41
CONTROLE...................................................................................................................................................................... 42
EMBALLAGE ET STOCKAGE ............................................................................................................................................. 42
ENTRETIEN ..................................................................................................................................................................... 43
RESISTANCE DES MATERIAUX ........................................................................................................................................ 43
POSSIBILITÉS DE RÉUTILISATION .................................................................................................................................... 43
OBLIGATION DE DECLARATION ...................................................................................................................................... 43
ÉLIMINATION ................................................................................................................................................................. 43
DONNEES TECHNIQUES .................................................................................................................................................. 44
FR

5
Italiano
INTRODUZIONE .............................................................................................................................................................. 45
INFORMAZIONI GENERALI.......................................................................................................................................................... 45
SIMBOLI UTILIZZATI.................................................................................................................................................................. 45
IMPIEGO PREVISTO ........................................................................................................................................................ 47
DESCRIZIONE DEL PRODOTTO ........................................................................................................................................ 47
MESSA IN FUNZIONE E UTILIZZO .................................................................................................................................... 48
CONTROLLO INIZIALE................................................................................................................................................................ 48
GARANZIA ............................................................................................................................................................................. 48
MONTAGGIO.......................................................................................................................................................................... 48
SMONTAGGIO ........................................................................................................................................................................ 49
IMPIEGO DEL BRACCIO ARTICOLATO............................................................................................................................................. 49
IMPIEGO DEGLI APPOGGI PER IL BRACCIO...................................................................................................................................... 51
TRATTAMENTO (PULIZIA E DISINFEZIONE) ..................................................................................................................... 51
PRE-TRATTAMENTO................................................................................................................................................................. 51
PULIZIA MANUALE E DISINFEZIONE MEDIANTE STROFINAMENTO........................................................................................................ 52
CONTROLLO ................................................................................................................................................................... 53
IMBALLAGGIO E CONSERVAZIONE ................................................................................................................................. 53
MANUTENZIONE ............................................................................................................................................................ 53
RESISTENZA DEI MATERIALI ........................................................................................................................................... 54
RIUTILIZZABILITÀ............................................................................................................................................................ 54
OBBLIGO DI NOTIFICA .................................................................................................................................................... 54
SMALTIMENTO............................................................................................................................................................... 54
DATI TECNICI.................................................................................................................................................................. 54
IT

6
Español
INTRODUCCIÓN.............................................................................................................................................................. 55
INFORMACIONES GENERALES ..................................................................................................................................................... 55
SÍMBOLOS UTILIZADOS ............................................................................................................................................................. 55
USO PREVISTO................................................................................................................................................................ 57
DESCRIPCIÓN DEL PRODUCTO........................................................................................................................................ 57
PUESTA EN SERVICIO Y MANEJO .................................................................................................................................... 58
CONTROL A LA LLEGADA ........................................................................................................................................................... 58
GARANTÍA ............................................................................................................................................................................. 58
MONTAJE.............................................................................................................................................................................. 58
DESMONTAJE ......................................................................................................................................................................... 59
MANEJO DEL BRAZO ARTICULADO............................................................................................................................................... 59
MANEJO DEL ACOLCHADO PARA EL BRAZO.................................................................................................................................... 61
TRATAMIENTO (LIMPIEZA Y DESINFECCIÓN) .................................................................................................................. 61
TRATAMIENTO PREVIO ............................................................................................................................................................. 61
LIMPIEZA Y DESINFECCIÓN MANUALES FROTANDO.......................................................................................................................... 61
CONTROL ....................................................................................................................................................................... 62
EMBALAJE Y ALMACENAMIENTO ................................................................................................................................... 63
MANTENIMIENTO .......................................................................................................................................................... 63
RESISTENCIA DEL MATERIAL........................................................................................................................................... 63
REUTILIZABILIDAD.......................................................................................................................................................... 63
OBLIGACIÓN DE INFORMAR........................................................................................................................................... 63
ELIMINACIÓN ................................................................................................................................................................. 64
DATOS TÉCNICOS ........................................................................................................................................................... 64
ES

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Português
INTRODUÇÃO................................................................................................................................................................. 65
INFORMAÇÕES GERAIS.............................................................................................................................................................. 65
SÍMBOLOS UTILIZADOS ............................................................................................................................................................. 65
UTILIZAÇÃO CONFORME A FINALIDADE ......................................................................................................................... 67
DESCRIÇÃO DO PRODUTO.............................................................................................................................................. 67
COLOCAÇÃO EM FUNCIONAMENTO E FUNCIONAMENTO .............................................................................................. 68
CONTROLO AQUANDO DA ENTREGA ............................................................................................................................................ 68
GARANTIA ............................................................................................................................................................................. 68
MONTAGEM .......................................................................................................................................................................... 68
DESMONTAGEM ..................................................................................................................................................................... 69
OPERAÇÃO DO BRAÇO ARTICULADO ............................................................................................................................................ 69
UTILIZAÇÃO DA ALMOFADA DO BRAÇO......................................................................................................................................... 71
PREPARAÇÃO (LIMPEZA E DESINFEÇÃO) ........................................................................................................................ 71
PRÉ-TRATAMENTO .................................................................................................................................................................. 71
LIMPEZA E DESINFEÇÃO MANUAIS COM UM PANO.......................................................................................................................... 71
CONTROLO..................................................................................................................................................................... 73
EMBALAGEM E ARMAZENAMENTO ............................................................................................................................... 73
MANUTENÇÃO ............................................................................................................................................................... 73
RESISTÊNCIA DO MATERIAL............................................................................................................................................ 73
REUTILIZAÇÃO................................................................................................................................................................ 74
DEVER DE NOTIFICAR ..................................................................................................................................................... 74
ELIMINAÇÃO .................................................................................................................................................................. 74
DADOS TÉCNICOS........................................................................................................................................................... 74
PT

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Nederlands
INLEIDING ...................................................................................................................................................................... 75
ALGEMENE INFORMATIE ........................................................................................................................................................... 75
GEBRUIKTE SYMBOLEN ............................................................................................................................................................. 75
BEOOGD GEBRUIK.......................................................................................................................................................... 77
PRODUCTBESCHRIJVING ................................................................................................................................................ 77
INBEDRIJFSTELLING EN BEDIENING ................................................................................................................................ 78
INGANGSCONTROLE................................................................................................................................................................. 78
GARANTIE.............................................................................................................................................................................. 78
MONTAGE............................................................................................................................................................................. 78
DEMONTAGE.......................................................................................................................................................................... 79
BEDIENING VAN DE SCHARNIERARM ............................................................................................................................................ 79
BEDIENING VAN HET ARMKUSSEN ............................................................................................................................................... 81
VOORBEREIDING (REINIGING EN DESINFECTIE).............................................................................................................. 81
VOORBEHANDELING ................................................................................................................................................................ 81
HANDMATIGE REINIGING EN DESINFECTIE DOOR WISSEN ................................................................................................................. 81
CONTROLE...................................................................................................................................................................... 82
VERPAKKING EN OPSLAG ............................................................................................................................................... 83
ONDERHOUD ................................................................................................................................................................. 83
MATERIAALBESTENDIGHEID........................................................................................................................................... 83
HERBRUIKBAARHEID ...................................................................................................................................................... 83
VERPLICHTING TOT KENNISGEVING ............................................................................................................................... 84
VERWIJDERING .............................................................................................................................................................. 84
TECHNISCHE GEGEVENS ................................................................................................................................................. 84
NL

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Dansk
INDLEDNING................................................................................................................................................................... 85
GENEREL INFORMATION ........................................................................................................................................................... 85
ANVENDTE SYMBOLER.............................................................................................................................................................. 85
FORSKRIFTSMÆSSIG ANVENDELSE................................................................................................................................. 87
PRODUKTBESKRIVELSE................................................................................................................................................... 87
IBRUGTAGNING OG BETJENING ..................................................................................................................................... 88
KONTROL VED MODTAGELSE...................................................................................................................................................... 88
GARANTI ............................................................................................................................................................................... 88
MONTERING .......................................................................................................................................................................... 88
AFMONTERING ....................................................................................................................................................................... 89
BETJENING AF LEDARM............................................................................................................................................................. 89
BETJENING AF ARMPUDE........................................................................................................................................................... 91
BEHANDLING (RENGØRING OG DESINFICERING) ............................................................................................................ 91
FORBEHANDLING .................................................................................................................................................................... 91
MANUEL RENGØRING OG DESINFICERING VED AFTØRRING............................................................................................................... 91
KONTROL ....................................................................................................................................................................... 92
EMBALLERING OG OPBEVARING .................................................................................................................................... 93
VEDLIGEHOLDELSE ......................................................................................................................................................... 93
MATERIALEBESTANDIGHED............................................................................................................................................ 93
GENANVENDELIGHED..................................................................................................................................................... 93
UNDERRETNINGSPLIGT .................................................................................................................................................. 94
BORTSKAFFELSE ............................................................................................................................................................. 94
TEKNISKE DATA.............................................................................................................................................................. 94
DA

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Suomi
JOHDANTO..................................................................................................................................................................... 95
YLEISTÄ................................................................................................................................................................................. 95
KÄYTETYT SYMBOLIT ................................................................................................................................................................ 95
MÄÄRÄYSTENMUKAINEN KÄYTTÖ................................................................................................................................. 97
TUOTTEEN KUVAUS........................................................................................................................................................ 97
KÄYTTÖÖNOTTO JA KÄYTTÖ .......................................................................................................................................... 98
VASTAANOTTOTARKASTUS ........................................................................................................................................................ 98
TAKUU.................................................................................................................................................................................. 98
ASENNUS............................................................................................................................................................................... 98
PURKAMINEN......................................................................................................................................................................... 99
NIVELVARREN KÄYTTÖ.............................................................................................................................................................. 99
KÄSIVARSIPEHMUSTEEN KÄYTTÖ............................................................................................................................................... 101
VALMISTELU (PUHDISTAMINEN JA DESINFIOINTI) ....................................................................................................... 101
ESIKÄSITTELY........................................................................................................................................................................ 101
PUHDISTAMINEN KÄSIN JA DESINFIOINTI PYYHKIMÄLLÄ ................................................................................................................. 101
TARKASTUS .................................................................................................................................................................. 102
PAKKAAMINEN JA VARASTOINTI.................................................................................................................................. 103
HUOLTO ....................................................................................................................................................................... 103
MATERIAALIN KESTÄVYYS............................................................................................................................................ 103
UUDELLEENKÄYTETTÄVYYS.......................................................................................................................................... 103
ILMOITUSVELVOLLISUUS.............................................................................................................................................. 103
HÄVITTÄMINEN............................................................................................................................................................ 104
TEKNISET TIEDOT ......................................................................................................................................................... 104
FI

11
Norsk
INNLEDNING ................................................................................................................................................................ 105
GENERELL INFORMASJON........................................................................................................................................................ 105
SYMBOLER SOM BRUKES ......................................................................................................................................................... 105
RIKTIG BRUK ................................................................................................................................................................ 107
PRODUKTBESKRIVELSE................................................................................................................................................. 107
BRUK OG BETJENING.................................................................................................................................................... 108
MOTTAKSKONTROLL .............................................................................................................................................................. 108
GARANTI ............................................................................................................................................................................. 108
MONTERING ........................................................................................................................................................................ 108
DEMONTERING..................................................................................................................................................................... 109
BETJENE LEDDARMEN............................................................................................................................................................. 109
BETJENE ARMPOLSTRINGEN..................................................................................................................................................... 111
KLARGJØRING (RENGJØRING OG DESINFISERING)........................................................................................................ 111
FORBEHANDLING .................................................................................................................................................................. 111
MANUELL RENGJØRING OG DESINFISERING VED AVTØRKING........................................................................................................... 111
KONTROLL.................................................................................................................................................................... 112
EMBALLERING OG OPPBEVARING ................................................................................................................................ 113
SERVICE........................................................................................................................................................................ 113
MATERIALBESTANDIGHET ............................................................................................................................................ 113
GJENBRUKBARHET ....................................................................................................................................................... 113
INFORMASJONSPLIKT................................................................................................................................................... 113
KASSERING................................................................................................................................................................... 114
TEKNISKE DATA............................................................................................................................................................ 114
NO

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Svenska
INLEDNING................................................................................................................................................................... 115
ALLMÄN INFORMATION.......................................................................................................................................................... 115
TILLÄMPADE SYMBOLER.......................................................................................................................................................... 115
AVSEDD ANVÄNDNING ................................................................................................................................................ 117
PRODUKTBESKRIVNING................................................................................................................................................ 117
ANVÄNDNING OCH HANTERING .................................................................................................................................. 118
INGÅNGSKONTROLL ............................................................................................................................................................... 118
GARANTI ............................................................................................................................................................................. 118
MONTERING ........................................................................................................................................................................ 118
DEMONTERING..................................................................................................................................................................... 119
LEDARMENS HANTERING......................................................................................................................................................... 119
DYNANS HANTERING.............................................................................................................................................................. 121
FÖRBEDELSER (RENGÖRING OCH DESINFICERING) ....................................................................................................... 121
FÖRBEHANDLING .................................................................................................................................................................. 121
MANUELL RENGÖRING OCH DESINFICERING MED TORKNING........................................................................................................... 121
KONTROLL.................................................................................................................................................................... 122
FÖRPACKNING OCH FÖRVARING.................................................................................................................................. 123
UNDERHÅLL ................................................................................................................................................................. 123
MATERIALBESTÄNDIGHET ............................................................................................................................................ 123
ÅTERANVÄNDNING...................................................................................................................................................... 123
RAPPORTERINGSKRAV ................................................................................................................................................. 123
AVFALLSHANTERING .................................................................................................................................................... 124
TEKNISKA DATA ........................................................................................................................................................... 124
SV

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Polski
WSTĘP.......................................................................................................................................................................... 125
INFORMACJE OGÓLNE ............................................................................................................................................................ 125
ZASTOSOWANE SYMBOLE........................................................................................................................................................ 125
ZASTOSOWANIE ZGODNE Z PRZEZNACZENIEM ............................................................................................................ 127
OPIS PRODUKTU .......................................................................................................................................................... 127
ROZRUCH I OBSŁUGA ................................................................................................................................................... 128
KONTROLA WEJŚCIOWA.......................................................................................................................................................... 128
RĘKOJMIA............................................................................................................................................................................ 128
MONTAŻ............................................................................................................................................................................. 128
DEMONTAŻ.......................................................................................................................................................................... 129
OBSŁUGA RAMIENIA PRZEGUBOWEGO....................................................................................................................................... 129
OBSŁUGA PODUSZKI PODPÓRKI ................................................................................................................................................ 131
PRZYGOTOWANIE (CZYSZCZENIE I DEZYNFEKCJA) ........................................................................................................ 131
PROCEDURA WSTĘPNA ........................................................................................................................................................... 131
CZYSZCZENIE RĘCZNE I DEZYNFEKCJA POPRZEZ PRZECIERANIE.......................................................................................................... 131
KONTROLA ................................................................................................................................................................... 132
OPAKOWANIE I PRZECHOWYWANIE ............................................................................................................................ 133
KONSERWACJA ............................................................................................................................................................ 133
WYTRZYMAŁOŚĆ MATERIAŁU ...................................................................................................................................... 133
MOŻLIWOŚĆ PONOWNEGO ZASTOSOWANIA .............................................................................................................. 133
OBOWIĄZEK POWIADOMIENIA.................................................................................................................................... 133
UTYLIZACJA .................................................................................................................................................................. 134
DANE TECHNICZNE ....................................................................................................................................................... 134
PL

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中文
导言 ............................................................................................................................................................................. 135
一般信息.......................................................................................................................................................................... 135
所采用的标志.................................................................................................................................................................. 135
按规定使用.................................................................................................................................................................. 137
产品说明...................................................................................................................................................................... 137
首次使用和操作 .......................................................................................................................................................... 138
收货检验.......................................................................................................................................................................... 138
担保 ................................................................................................................................................................................. 138
装配 ................................................................................................................................................................................. 138
拆卸 ................................................................................................................................................................................. 139
关节臂的操作.................................................................................................................................................................. 139
手臂软垫的操作.............................................................................................................................................................. 140
处理（清洁和消毒）................................................................................................................................................... 140
预处理.............................................................................................................................................................................. 141
通过擦拭进行手动清洁和消毒...................................................................................................................................... 141
检查 ............................................................................................................................................................................. 142
包装和仓储.................................................................................................................................................................. 142
维护 ............................................................................................................................................................................. 142
材料耐受性.................................................................................................................................................................. 143
重复使用性.................................................................................................................................................................. 143
通知义务...................................................................................................................................................................... 143
废物处置...................................................................................................................................................................... 143
技术数据...................................................................................................................................................................... 143
ZH

15
日本語
始めに........................................................................................................................................................................... 144
一般情報.......................................................................................................................................................................... 144
本説明書で使用する記号 ................................................................................................................................................ 144
目的に合った使用方法 ................................................................................................................................................. 146
製品説明...................................................................................................................................................................... 146
使用開始と使用方法.................................................................................................................................................... 147
受領検査.......................................................................................................................................................................... 147
保証 ................................................................................................................................................................................. 147
組み立て........................................................................................................................................................................... 147
分解 ................................................................................................................................................................................. 148
関節アームの操作............................................................................................................................................................. 148
アームパッドの操作 ............................................................................................................................................................ 149
前処理（清掃と消毒）................................................................................................................................................ 150
前処理.............................................................................................................................................................................. 150
手による清掃、拭き消毒................................................................................................................................................... 150
点検 ............................................................................................................................................................................. 151
梱包と保管................................................................................................................................................................... 152
保守点検...................................................................................................................................................................... 152
マテリアルの耐久性....................................................................................................................................................... 153
再利用性...................................................................................................................................................................... 153
通知義務...................................................................................................................................................................... 153
廃棄 ............................................................................................................................................................................. 153
テクニカルデータ............................................................................................................................................................ 154
JA

16
Introduction
Thank you for buying our product.
You have chosen a high quality Swiss product.
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.
Manufacturer
Baitella AG
Thurgauerstr. 70
CH-8050 Zürich
Switzerland
Phone: [phone] Baitella GmbH
Fax: [phone] Moltkestrasse 41
E-Mail: [email protected] DE-78532 Tuttlingen
Internet: www.fisso.com Germany
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
Symbol
Description
Symbol for products that are put into use according to the regulation (EU) 2017/745
on medical devices
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.
European authorized representative
Distributor
Importer
Medical device (in this instruction for use indicated as «product»)
Unique Device Identification
Article number
Date of manufacture
Lot number
Serial number
Quantity
Gentle washing
Do not bleach
Iron with low heat
Dry clean, any solvent except trichloroethylene
EN

18
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.
DANGER!
All FISSO components are designed for optimal performance when used together with the
FISSO holding system. If a products / component 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 regulation (EU) 2017/745 on medical devices.
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
The product range along with all related information can be reviewed on www.fisso.com.
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 450 mm
VE 450 mm
VE 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
Rail clamping base
Radial setting clamp
Radial setting clamp
Fisso (partly
optional)
Fastening straps
(2 pcs)
optional
Art. # 5.890-VE
optional
Art. # 5.890-VE
optional
Art. # 5.890-VE
optional
Art. # 5.890-VE
VE = anatomically shaped visco-elastic pad
Before delivery to the clients, the components are rigidly threaded to the articulated arm and additionally
fastened with glue.
Pos. 1
EN

19
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 24 months 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 Sales and General Delivery Conditions.
Assembly
WARNING
All handling must be done with as little force as possible and as much force as
necessary!
WARNING!
The assembly and handling of the products must be done manually and without
additional tools.
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!
If the base / column is not correctly tightened, it may become loose and may cause injuries
to the patient.
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.
EN
Pos. 2
Pos. 2
Pos. 1
Pos. 1
Pos. 5
Pos. 4
Pos. 3

20
Disassembly
The disassembly of the set must 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
DANGER!
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!
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!
A damaged product can cause injuries.
Use only products in proper condition and check functionality.
DANGER!
Threat through inappropriate handling
Follow instructions for use of arm support and surgical table
WARNING!
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!
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.
A
EN