etac 78570 Rex Wall Mounted Toilet Arm User Manual
- June 1, 2024
- Etac
Table of Contents
etac 78570 Rex Wall Mounted Toilet Arm
General information
Thank you for choosing an Etac product. 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
Rex is a foldable, wall-mounted toilet arm support, available in three different lengths.
Intended purpose
Rex (hereafter also referred to as ”the device” or ”the product”), is a
medical device intended for the 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.
- Mounting on walls with insufficient load-bea-ring capacity or with unsuitable fixtures can affect user safety. Mounting of the device and assessment of the wall’s load-bearing capacity must be carried out by a qualified person.
- A defective device must not be used.
- Ignoring installation or assembly instructi-ons may result in injury.
- 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 that occurs with use of the device, it should be
reported to your local dealer and the national competent authority on time.
The local dealer will forward information to the manufacturer.
Customization
is everything that goes beyond the manual’s instructions and settings. Devices
specially adapted by the customer must not retain Etacs CE marking. Etacâs
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
- Content of the delivery
- Supporting legs
- Wall bracket
- Arm support
- Adjustable ferrule
- Product label
- Item no label
Symbols
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) 8-9. Cleaning (see maintenance)
- Read instructions for use
- Product weight
Explanation item no label
- 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
Installation options
May be mounted on walls with sufficient load-bearing capacity only. Please
ensure that suitable fixtures are used. For mounting in concrete, plywood or
wooden joists, we recommend the screw set accessory.
Installation
Use
Maintenance
Clean the device with a solvent-free detergent which has a pH of 5-9, or with a 70% disin-fectant 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
- Toilet paper holder
- Storage basket
- Screw kit
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
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>