etac 78390 Smart Swift Freestanding User Manual

: May 15, 2024
: Etac

Table of Contents

etac 78390 Smart Swift Freestanding
Product Information
Product Usage Instructions
Symbols, labels
Explanation item no label
Technical data
Installation
Dismantling
Accessories
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

etac 78390 Smart Swift Freestanding

Product Information

Specifications

Product Models: Swift, Smart, Edge, Easy
Weight Capacity: 130 kg – 200 kg (286 lbs – 440 lbs)
Dimensions:
- Swift: 420-570 mm height, 540 x 410 mm seat size
- Smart: 420-570 mm height, 430 x 380 mm seat size
- Edge: 420-570 mm height, 450 x 405 mm seat size
- Easy: 420-570 mm height, 400 mm seat size
Weight: Ranges from 2.4 kg to 3.9 kg (5 lbs – 10 lbs)

Product Usage Instructions

Device Description
The Swift, Smart, Edge, and Easy are medical devices designed to provide stability and support in the shower or bathtub for individuals with functional impairments. They facilitate personal hygiene and are intended for users with a height of 146 cm or more or a mass of 40 kg or more.

Intended Purpose
The products are meant to alleviate or compensate for functional impairments resulting from injury or disability. They aim to improve personal hygiene routines and ensure safety during shower or bath activities.

Intended User Group
The devices are suitable for individuals based on their functional ability rather than a specific diagnosis, health condition, or age. They are recommended for users with a height of 146 cm or more or a mass of 40 kg or more.

Frequently Asked Questions (FAQ)

Q: Can the product be used by individuals under 146 cm in height?
A: The product is recommended for individuals with a height of 146 cm or more for optimal functionality and safety.
Q: What is the weight capacity of the Easy model?
A: The Easy model has a weight capacity of up to 130 kg (286 lbs).
Q: Where can I find additional product documentation?
A: Additional product documentation can be found on www.etac.com under the International and Local websites link.

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
Swift, Smart, Edge and Easy have a stable design with built-in flexibility that adapts to uneven floors. All devices have height- adjustable legs that are simple to attach. The legs are angled outwards to maximise stability regardless of height. All devices are equipped with ferrules that provide good grip, even on uneven and wet floors. The devices can be tilted forward to further facilitate standing up. There are different shapes of the seats and they are all designed with an anti-slip pattern, ensuring a safe and non-slip seat even when it is wet. The seats also have drainage holes that effectively remove excess water.

Intended purpose
Swift, Smart, Edge and Easy (hereafter also referred to as ”the device” or ”the product”), are medical devices intended for alleviation of or compensation for a functional impairment due to an injury or disability. The device is designed to facilitate personal hygiene and provide stability and support in the shower or the bathtub.

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.

When moving sideways, do not lean on just one arm support.
Do not stand on the device
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 require-ments 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

$etac-78390-Smart-Swift-Freestanding-$1$$

Seat
Leg
Ferrule
Arm support
Back support
Product label
Item no label

Symbols, labels

$etac-78390-Smart-Swift-Freestanding-$2$$

Symbols in the manual and on the device:

1 Warning, precaution or limitation.
2 Useful advice and tips.
3 Material for recycling.
4 A height difference of more than one hole is not allowed for chair legs.
5 When moving sideways, do not lean on just one arm support.
4 Maximum user weight (see technical data)
7-8. Cleaning (see maintenance)
9. Read instrucrions for use
10. Showing option 1 of two possible options.
11. Showing option 2 of two possible options.
12. Product weight

Explanation item no label

$etac-78390-Smart-Swift-Freestanding-$3$$

Product name
Product description
Serial number
Item number
Date of manufacture 6. 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

$etac-78390-Smart-Swift-Freestanding-$4$$

*Item no. 81901070 / 81901080 / 81901090 / 81951070 / 81951080 / 81951090 / 81701480

$etac-78390-Smart-Swift-Freestanding-$6$$

Installation

$etac-78390-Smart-Swift-Freestanding-$7$$

A height difference of more than one hole is not allowed for chair legs.

Dismantling

$etac-78390-Smart-Swift-Freestanding-$8$$

$etac-78390-Smart-Swift-Freestanding-$10$$

Back support
Leg
Arm support

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.