etac 78352 OptimaL toilet User Manual
- May 14, 2024
- Etac
Table of Contents
etac 78352 OptimaL toilet
Product Information
Specifications:
- Brand: Etac
- Product Name: OptimaL
- Model Number: 78352
- Release Date: 2023-11-01
- Version: 9
- Dimensions: 735×800 mm (folded), 175 mm (depth)
- Weight: 3.1 kg
- Maximum User Weight: 150 kg
Product Usage Instructions
Device Description:
OptimaL is a foldable wall-mounted toilet arm support with an integrated
supporting leg.
Intended Purpose:
The device is designed to facilitate access to the toilet for individuals with
restricted functional ability. It provides stability and support for sitting
down and standing up before and after performing toilet needs.
Intended User Group:
Individuals with a height of 146 cm or more, or a mass of 40 kg or more can
use the device. Caregivers and clinicians/technicians may also use it.
Intended Environment:
The device is suitable for indoor use in home environments or institutions,
particularly in bathrooms. Avoid using it in corrosive environments like
swimming pools.
Intended Application:
The device can be used multiple times per day, for short-term or long-term
use, in contact with intact skin. It is suitable for refurbishment and reuse.
Expected Service Life:
The device has an expected service life of 10 years. For detailed information,
refer to www.etac.com.
Indications:
The device is suitable for individuals with balance issues,functional
impairments, and a history of falls due to disability.
Contraindications:
There are no known contraindications for using the device.
Warnings:
- Installation must be done by a professional.
- Ignoring installation instructions may lead to injury.
- Do not use a defective device.
Frequently Asked Questions (FAQ):
Q: Can OptimaL be used in swimming pools?
A: No, the device is not suitable for use in swimming pools or similar
corrosive environments.
Q: What is the maximum weight capacity of OptimaL?
A: The maximum user weight capacity is 150 kg.
Q: How often can the device be used?
A: The device can be used several times per day for short-term or long-
term use.
General information
Thank you for choosing an Etac product.
In order to avoid damage during assembly,handling and use, it is important to
read this manual and save it for future reference. You can also find it at
www.etac.com. You can select your language via the “International” and “Local
websites” link. Here you will also find other product documentation, such as
prescriber information, pre-purchase guide,and reconditioning instructions.
In the manual, the user is the person sitting in the chair. The carer is the
person helping the user.
Device description
OptimaL is a foldable wall-mounted, toilet arm support with an integrated
supporting leg.
Intended purpose
OptimaL (hereafter also referred to as ”the device” or ”the product”), is a
medical device intended for alleviation of or compensation for a functional
impairment due to an injury or disability. The device is designed to
facilitate access to the toilet for people with restricted functional ability.
The raised seat and/or arm supports intend to provide stability and support
when sitting down and standing up before and after performing toilet needs.
Intended user group
The user group for the device is based on the individual’s functional ability
and not on a specific diagnosis, health condition or age.
It is intended for individuals with a height of 146 cm or more, or a mass of
40 kg or more.
Secondary users of the device are caregivers providing assistance and
clinicians/technicians who set up the device.
Intended environment
The device is intended for indoor use at home environments or institutions and
is suitable for use in bathrooms, but not swimming pools or similar corrosive
environments.
Intended application
The device is intended for short-term and long-term use and can be applied
several times per day. The device is intended to be used in contact with
intact skin.
The device is intended for refurbishment and reuse.
Expected service life
The expected service life is 10 years. For complete information regarding the
service life of the device, see www.etac.com.
Indications
Indication for use is disability, including, but not limited to, an individual
with fluctuating balance issues, physiological and/or functional impairment,
and/or a history of falls.
Contraindications
There are no known contraindications.
Warnings
Warnings describing a risk element for a specific action or setting of the
device can be found in the relevant section.
- Installation may only be carried out by a professional.
- Ignoring installation or assembly instructions may result in injury.
- A defective device must not be used.
- Do not stand on the device
Declaration of conformity
The device meets the requirements of the Medical Device Regulation (EU)
2017/745.
The device is tested and meets the requirements of the EN ISO 10993-1, SS EN
12182.
Pre-purchase information
Pre-purchase information can be found at www.etac.com.
Adverse event
In case of an adverse event occurred in relation to use of the device, it
should be reported to your local dealer and the national competent authority
in a timely manner.
The local dealer will forward information to the manufacturer.
Customization
is everything that goes beyond the manual’s instructions and settings. Device
specially adapted by the customer must not retain Etac’s CE marking. Etac’s
warranty expires. If there is any uncertainty regarding the execution of the
customization, consult Etac.
Device coupled with another device may not retain either device’s CE mark
unless combination agreements exist. Contact Etac for current information.
Device description…………………………..Figure A
- Supporting leg
- Handle
- Wall bracket
- Arm support with handle 5. Product label
- Item no label
Symbols………………………………………….Figure B
Symbols in the manual and on the device:
- Warning, precaution or limitation.
- Useful advice and tips.
- Material for recycling.
- Maximum user weight (see technical data)
- Cleaning
- (see maintenance)
- Read instructions for use
- Product weight
Explanation item no label:………………Figure C
- Product name
- Product description
- Serial number
- Item number
- Date of manufacture
- Barcode acc.to GS1-128 GTIN-14 and serial number*
The device’s date of manufacture can be read from the barcode on the device. The number 11 is shown below the barcode in brackets. The number combination after these brackets is the date of manufacture.
Technical data…………………………………Figure D
Assembly……………………………………….. Figure E
Maintenance
Clean the device with a solvent-free detergent which has a pH of 5-9, or with
a 70% disinfectant solution. Can be decontaminated at max. 85°C if so
required.
Constituent materials are corrosion-resistant.
5-year guarantee against material and manufacturing defects. For terms and
conditions,see www.etac.com.
Storage
The device should be stored indoors in a dry place at a temperature above 5°C.
If the device has been stored for a long time (more than four months), its
function must be checked by an expert before use.
Accessories……………………………………. Figure F
- Attachment for signal device
Etac Ltd.
Unit 60, Hartlebury Trading Estate,
Hartlebury, Kidderminster,
Worcestershire, DY10 4JB
+44 121 561 2222
Promefa AG
Kasernenstrasse 3A
8184 Bachenbülach, CH
+41 44 872 97 79
Etac Supply Center AB
Långgatan 12
SE-334 33 Anderstorp
+46 371 58 73 00
info@etac.com
www.etac.com