User Manual
60 Pages
Preview
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BM43099 Rev. 10.0
CONTENT
Symbols4 Device overview
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General10 English10 Svenska14 Norsk18 Dansk22 Suomi26 Deutsch30 Nederlands34 Français38 Italiano42 Español46
Handling50 Rising51 Lowering53 Warnings54 Information56
Technical data
BM43099 Rev. 10.0
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EN: Date of manufacture. YYYY-MM-DD (year/month/date) SV: Tillverkningsdatum. ÅÅÅÅ-MM-DD (år/månad/dag) NO: Produksjonsdato. ÅÅÅÅ-MM-DD (år/måned/dag) DA: Produktionsdato. ÅÅÅÅ-MM-DD (år/måned/dag) FI: Valmistuspäivä. VVVV-KK-DD (vuosi/kuukausi/Päivä) DE: Herstellungs-datum. JJJJ-MM-DD (Jahr/Monat/Tag) NL: Productie-datum JJJJ-MM-DD (jaar/maand/dag) FR: Date de fabrication. AAAA-MM-DD (année/mois/jour) IT: Data di produzione. AAAA-MM-DD (anno/mese/giorno) ES: Fecha de fabricación. AAAA-MM-DD (año/mes/dìa)
EN: Manufacturer SV: Tilverkare NO: Produsent DA: Producent FI: Valmistaja DE: Hersteller NL: Fabrikant FR: Fabricant IT: Produttore ES: Fabricante
EN: CE marked SV: CE-märkt NO: CE-merket DA: CE-mærket FI: CE-merkintä DE: CE-konform NL: CE-markering FR: Marquage CE IT: Marchio CE ES: Marchio CE
EN: Medical device SV: Medicinteknisk produkt NO: Medisinsk utstyr DA: Medicinsk udstyr FI: Lääkinnällinen laite DE: Medizinprodukt NL: Medisch hulpmiddel FR: Dispositif médical IT: Dispositivo medico ES: Producto sanitario
EN: Serial number SV: Serienummer NO: Serienummer DA: Serienummer FI: Sarjanumero DE: Seriennummer NL: Serienummer FR: Numéro de série IT: Numero di serie ES: Número de serie
EN: Catalogue number SV: Katalognummer NO: Katalognummer DA: Katalognummer FI: Luettelonumero DE: Katalognummer NL: Catalogusnummer FR: Référence catalogue IT: Numero di catalogo ES: Número de catálogo
EN: UKCA marked SV: UKCA-märkt NO: UKCA-merket DA: UKCA-mærket FI: UKCA-merkintä DE: UKCA-konform NL: UKCA-markering FR: Marquage UKCA IT: Marchio UKCA ES: Marchio UKCA
EN: Ready for use SV: Redo för användning NO: Klar til bruk DA: Klar til brug FI: Valmis käytettäväksi DE: Bereit zum Benutzen NL: Klaar om te gebruiken FR: Prêt à l’emploi IT: Pronto per l’uso ES: Listo para usar
EN: Incorrect use SV: Felaktig användning NO: Feil bruk DK: Forkert brug FI: Virheellinen käyttö DE: Falsch NL: Onjuist gebruik FR: Utilisation incorrecte IT: Uso errato ES: Uso incorrecto
EN: Weight of unit SV: Enhetens vikt NO: Enhetens vekt DA: Enhedens vægt FI: Laitteen paino DE: Gewicht des Geräts NL: Gewicht van eenheid FR: Poids de l’unité IT: Peso dell’unità ES: Peso de la unidad
EN: Max. user weight SV: Max. brukarvikt NO: Maks. brukervekt DA: Maks. brugervægt FI: Käyttäjän enimmäispaino DE: Max. Benutzergewich NL: Max. gewicht gebruiker FR: Poids max. de l’utilisateur IT: Peso massimo dell’utente ES: Peso máximo del usuario
EN: Recyclable SV: Återvinningsbar NO: Gjenvinnbar DA: Genanvendelig FI: Kierrätettävissä DE: Recycelbar NL: Recyclebaar FR: Recyclable IT: Riciclabile ES: Reciclable
EN: Keep dry SV: Hålls torr NO: Må holdes tørr DA: Opbevares tørt FI: Pidä kuivana DE: Trocken halten NL: Droog bewaren FR: Garder au secl IT: Mantenere asciutto ES: Mantener seco
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BM43099 Rev. 10.0
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Updated according to legal req.
2021-03-19
Rev.
Description:
Revised Date: Revised By: Released Date: Released By: ECP ID:
ELJ
ELJ
16
2021-03-19
4 5 15 6 GS1-128 Size 76,5mm x 25,5mm Silver background
7 8
76,5mm
9
25,5mm
(01)XXXXXXXXXXXXXX(11)XXXXXX(21)XXXXXX ABCDEFGHIJ XXXXXX
YYYY-MM-DD
Etac A/S Parallelvej 3 DK-8751 Gedved www.etac.com
170 375
10 11
Serial number Art. number of marked product
12
13
14
For user manuel
17 (01)XXXXXXXXXXXXXX(11)XXXXXX(21)XXXXXX ABCDEFGHIJ XXXXXX
1 EN: Handle SV: Handtag NO: Håndtak DA: Håndtag FI: Kahva DE: Handgriff NL: Handgreep FR: Poignée IT: Impugnatura ES: Asa
YYYY-MM-DD
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Etac A/S Parallelvej 3 DK-8751 Gedved www.etac.com
2 Category: Scale: Volume (mm3): Designed By: ELJ
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EN: Attachment for accessories (2 heights) SV: Fäste för tillbehör (två höjder) Project ID: NO: Festepunkt forMaterial: tilbehør (2 høyder) Format: State: DA: Fastgørelse af tilbehør (to højder) APPROVED FI:Weight Kiinnike varusteille (2 korkeutta) Date Created: (g): DE: Befestigung für2020-11-24 Zubehör (2 Höhen) / Document number: / Title: NL:IDDescription Bevestiging voor accessoires (2 Drawing hoogtes) label 03-347 FR: Fixation pour accessoires (2 hauteurs) IT: Fissaggio per accessori (2 altezze) ES: Fijación para accesorios (2 alturas) 8
EN: Screw SV: Skruv NO: Skrue DA: Skrue FI: Ruuvi DE: Schraube NL: Schroef FR: Vis IT: Vite ES: Tornillo BM43099 Rev. 10.0
ENGLISH
General Thank you for choosing an Etac device. This manual must be read thoroughly before you start using the device as it contains important safety information and gives instructions on how to use the device correctly. Visit www.etac.com for all relevant product documentation, for example the user manual, maintenance and recycling instructions. You can select your language via the “International” and “Local websites” link. You can also consult the QR code on the device for further information and instructions.
Copyright
This document is the property of Etac A/S. The content shall not be modified in whole or part without prior approval of Etac A/S.
Disclaimer
Etac continuously makes improvements to our devices and information. We therefore reserve the right to modify our devices and instructions for use without prior notice. Consult www.etac.com to find the latest version of the documentation.
Declaration of Conformity
The device mentioned in this manual and the different models hereof comply with the Medical Device Regulation (EU) 2017/745. The device is classified as a Class I medical device.
Product standards
The device has been tested and complies with the requirements applicable for this type of device in the below mentioned standards: • ISO 21856:2022 Assistive products - General requirements and test methods
Warranty
Please refer to www.etac.com/support. If the customer makes adjustments, repairs or uses combinations not predetermined by Etac, the Etac CE certification and Etac warranty will not be valid. If in doubt, please contact Etac.
Notice
Any serious incident that has occurred in relation to the device should be reported to your distributor/representative and the national competent authority within your region in a timely manner. The distributor/representative will forward the information to the manufacturer.
Pre-sales information
Please visit www.etac.com.
Device description Etac supplies a wide selection of sit-to-stand devices. These devices assist people with impaired mobility to be transferred between two sitting positions. See www.etac.com for a complete overview of sit-to-stand devices. The Molift Raiser Pro is a sit-to-stand device ideal for short transfers between sitting positions, such as wheelchair to bed or chair. It’s designed for easy maneuvering in tight space. With multiple grip options on its ergonomic handle, soft padded leg support, and adjustable height, it ensures comfort and safety. The base plate has a sloped edge for easy foot placement, with a cutout designed to fit a toilet, and a handle allowing convenient carrying in two parts. A central brake locks both wheels with a single-foot activation.
Benefits
The clinical benefits of Molift Raiser Pro are: • Reduces work-related injuries or strain of carer. • Enables early rehabilitation. • Comfortable and safe standing transfers. • Supports the user to use their physical ability. • Enables single-handed care.
Materials
Powder coated aluminum, Plastic, Steel, Polyuretan foam.
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BM43099 Rev. 10.0
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Introduction The person referred to as “the user” is the person who is standing on the product. “The carer” is the person who manoeuvres the product.
Intended purpose
Indications
Intended user
Contraindications
The sit-to-stand aid is an assistive device intended for alleviation of, or compensation for, a functional impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves over shorter distances to another sitting position to/from a bed, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. The device can be used for children, adults and elderly people with a need for support to stand up and be transferred over shorter distances between sitting positions.
Intended environment
For indoor use on horizontal surfaces in acute care, long-term care and home care.
For users who are in need of support to stand up and be transferred over shorter distances between sitting positions; e.g. people suffering from pain, reduced range of motion in their joints, stiffness and muscle weakness. Not an exhaustive list. The user group for the device is based on individual health and mobility function and not on a specific diagnosis or age. There are no known contraindications.
Precautions
The user should be able to follow instructions, grip and pull up their own body weight, maintain a good core stability and load at least one leg.
Training requirements
Only carers who have read and understood the user manual are allowed to use the device.
Safety information The safety of both user and carer must never be jeopardized – if you suspect that the device has a malfunction you must put it in quarantine marked “out of order” and call your local distributor/representative. Safety signs, safety measures and warnings symbols are given in the context relevant for the actual handling and/or operating situation – it is mandatory the given instruction is followed to avoid dangerous/hazardous situations. Signs, symbols and instructions placed on this device must never be covered or removed and must remain present and clearly legible throughout the entire lifetime of the device. Immediately replace or repair illegible or damaged signs, symbols, and instructions. Contact your distributor/ representative for instructions.
Patient transfer
Transfer of a user will always pose a certain risk. Therefore, a risk assessment must always be carried out before the transfer is performed. Warnings: • Never use the device for transportation of goods. • Never use the device for self-transportation. • Always transfer the user in a calm and stable speed. • Never leave a user unattended in the device. • The device is not intended to be used for prolonged periods of time. • Never use the device in the shower. • Never use the device for gait training.
BM43099 Rev. 10.0
Risk assessment
Do a risk assessment of the device, the individual user and the transfer situation, and document your analysis. You as the carer are responsible for the safety of the user. Plan the transfer in advance to ensure that it is performed as safe and smooth as possible. Remember to work ergonomically according to local recommendations. The carer has to be able to handle the weight of the user. To avoid serious injury, the user shall avoid extended reaching or leaning movements.
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EN The device • • • • • • • •
Always check – before each use: that the user has the required ability for the device. If needed use any suitable accessories. that the device is suitable for the user and the transfer situation. that the device does not have visible damage. that the wheels on the wheelchair or bed are locked during the transfer. that the device is locked when the user is moving from sitting to standing and vice versa. if the inspection reveals any safety risks, the device must immediately be taken out of service. never use a faulty or damaged device as it can cause personal injury. Contact your local distributer/representative for further instructions.
Materials
All used materials which are to be in direct contact with skin are biologically assessed and evaluated according to relevant standards. However, users/ carers who are allergic to any of the materials are recommend not to use the device.
Accessories
User manuals supplied with accessories must be read and understood before use. This includes any limitations in use and combinations. Information about accessories can be found on www.etac.com.
Spare parts
A list of spare parts is available at www.etac.com.
Combinations
When combining the device with other devices or accessories, the combination must not change the intended purpose of the devices or modify the devices in such a way that compliance with the applicable requirements may be affected. The person /company responsible for the combination of the devices must ensure that the applicable requirements are fulfilled. If safe working load (SWL) differs between sit-to-stand device and Molift Assist, the lowest load should always be used.
Assembly and supplied parts
Consult the assembly guide on www.etac.com.
Safety measures The base plate has visible feet contours and anti-slip surface for extra safety. The central brake provides auditive feedback when activated.
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BM43099 Rev. 10.0
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Service, cleaning and maintenance Maintenance and service
Maintenance and inspections of the device are wholly the responsibility of the owner of the device. Failure to maintain a device in accordance with the instructions may compromise the safety of the user and/or carer and may affect the expected lifetime of the device. Inspection of the device must be carried out regularly. Check: • that the device does not have visible damage. • that frames and handle are well fitted and screws are tightened. • that labels are readable. • that the wheels move smoothly. • that the brake works.
Expected lifetime
The device has an expected lifetime of 5 years under normal use. The lifetime of the device may vary depending on usage frequency, loads and washing/drying frequency and conditions.
Cleaning 70 10
Clean on a regular basis. Clean surfaces with a damp cloth using an appropriate pH-neutral detergent. Do not use solvents or strong liquids as this may damage surfaces on the device. For disinfection when needed; use isoPropyl alcohol or similar. Avoid abrasive cleaning products. Remove hair and filth from the wheels to ensure the wheels rotate freely and the brake functions properly. Make sure not to damage or remove labels when cleaning.
Reconditioning
Separate reconditioning document is available at www.etac.com.
Transportation, storage and disposal Transportation and storage
When the device is not in use, it can be stored under the following conditions:
Keep packaging away from children Keep away from fire
Disposal
The device contains no hazardous substances that require special disposal. Check if there are options available for recycling in an environmentally friendly way and follow the national provisions that apply. Dispose of the device according to the national provisions that apply.
Recycling
See the recycling instructions on www.etac.com, and follow the national provisions that apply.
The device can be stored and transported under temperatures between -25 to +70 °C and relative humidity between 15 - 93 %. It is recommended to store the device with activated brake.
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HANDLING EN EN: Handling
SV: Hantering
NO: Håndtering
DA: Håndtering
FI: Käsittely
DE:Handhabung
NL: Hanteren
FR: Manipulation
IT: Manipolazione
ES: Manipulación
Rising
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Warnings
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Information
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Technical data 10,7kg 23.6lbs
Dimensions A B C D
mm
Inches
541 1200 510 629
21.30 47.24 20.08 24.76
Degrees 75
E
F G
mm
Inches
541 300
21.30 11.81
B
C
E
A
D
F
G
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UK
CH
Etac Ltd. Unit 60, Hartlebury Trading Estate, Hartlebury, Kidderminster, Worcestershire, DY10 4JB +44 121 561 2222
Sodimed SA Ch. Praz-Devant 12 CH-1032 Romanel-sur-Lausanne +41 58 911 06 06
Etac A/S
+45 796 858 33
Parallelvej 3
DK-8751 Gedved
www.etac.com