etac 78186 Optima Lockable Instruction Manual

: May 15, 2024
: Etac

Table of Contents

etac 78186 Optima Lockable
Specifications
General information
Maintenance
FAQs
References
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etac 78186 Optima Lockable

Specifications

Product Name: Optima lockable
Model Number: 78186
Version: 7
Dimensions (Folded): 71.5 cm (length) x 21.5 cm (width)
Dimensions (Flipped Down): 91.5 cm (length) x 21.5 cm (width)
Weight: 2.4 kg
Maximum User Weight Capacity: 130 kg
Expected Service Life : 10 years

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
Optima lockable is a foldable, wall-mounted toilet arm support. It can be locked in its folded or flipped-down position.

Intended purpose
Optima lockable (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 a 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 describing a risk element for a specific action or setting of the device can be found in the relevant section.

WARNING: 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.

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 an adverse event occurs concerning the use of the device, it should be reported to your local dealer and the national competent authority promptly. The local dealer will forward the 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 Etac’s CE marking. Etac’s warranty expires.

If there is any uncertainty regarding the execution of the customization, consult Etac.
A device coupled with another device may not retain either device’s CE mark unless combination agreements exist. Contact Etac for current information.

Device description etac-78186-Optima-Lockable-
FIG-1

Wall bracket
Arm support with handle
Product label 4. Item no label

Symbols etac-78186-Optima-Lockable-FIG-2 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)
6. Cleaning (see maintenance)
Product weight

Explanation item no label etac-78186-Optima-Lockable-
FIG-3

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
Assembly

Maintenance

Clean the device with a solvent-free detergent that 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.

FAQs

Q: How do I install the Optima lockable?
- A: Please refer to Figure E in the user manual for detailed instructions on the installation process.
Q: Can the Optima lockable 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 the Optima lockable?
- A: The device can support a maximum user weight of 130 kg.
Q: Can the Optima lockable be reused?
- A: Yes, the device is intended for refurbishment and reuse.
Q: Where can I find more information about the service life of the Optima lockable?
- A: For complete information regarding the service life of the device, please visit www.etac.com.