User Manual - Swift Freestanding

Introduction

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, where you can select your language via the "International" and "Local websites" links. Here you will also find other product documentation, such as prescriber information, pre-purchase guides, and reconditioning instructions.

In this manual:

• User: The person sitting in the chair.
• Carer: The person helping the user.

Device Description

The Swift Freestanding is a raised toilet seat with adjustable telescopic legs and detachable arm supports, designed to be placed over the toilet. It can be used with one, two, or no arm supports. If the arm supports are not used, the opening provides a stable grip and support.

Intended Purpose

The Swift Freestanding is a medical device intended for alleviating or compensating for a functional impairment due to an injury or disability. It is designed to facilitate toilet access for people with restricted functional ability. The raised seat and/or arm supports provide stability and support when sitting down and standing up before and after performing toilet needs.

Intended User Group

The user group is based on the individual's functional ability, 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 include caregivers and clinicians/technicians who set up the device.

Intended Environment

The device is intended for indoor use in home environments or institutions and is suitable for use in bathrooms, but not in 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. It is intended for use in contact with intact skin and for refurbishment and reuse.

Expected Service Life

The expected service life is 10 years. For complete information, see www.etac.com.

Indications

Indication for use is disability, including, but not limited to, individuals 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.

• ⚠️Do not stand on the device.
• ⚠️Ignoring installation or assembly instructions may result in injury.
• ❌A defective device must not be used.
• ⚠️When moving sideways, do not lean on just one armrest.

Diagrams and Product Information

Diagram A: Product Parts

The Swift Freestanding consists of:

• 1. Seat
• 2. Leg
• 3. Ferrule
• 4. Product Label
• 5. Arm Support

Diagram B: Symbols

Symbols used in the manual and on the device:

• 1. ⚠️ Warning, precaution, or limitation.
• 2. ℹ️ 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 armrest.
• 6. Maximum user weight (see technical data).
• 7-8. Cleaning (see maintenance).
• 9. Product weight.

Diagram C: Product Label Explanation

The product label includes:

• 1. Product name
• 2. Product description
• 3. Serial number
• 4. Item number
• 5. Date of manufacture
• 6. Barcode (GS1-128 GTIN-14 and serial number). The date of manufacture can be read from the barcode; it is indicated by the number 11 in brackets followed by the date (YYYY-MM-DD).

Diagram D: Dimensions and Materials

Dimensions:

• Seat height adjustment range: 420-570 mm (16½"-22½")
• Seat dimensions: 300 x 215 mm (11¾" x 8½")
• Leg height (lowest): 210 mm (8¼")
• Leg height (highest): 450 mm (17¾")
• Overall width: 540 mm (21¼")
• Overall depth: 530-550 mm (20¾"-21¾")

Weight: 4.1 kg (9 lbs)

Maximum User Weight: 160 kg

Materials: PP, Alu, TPE, PE (indicated in diagrams).

Diagram E: Assembly

Assembly involves attaching the legs and arm supports. Steps are indicated with "click" indicators.

Diagram F: Dismantling

Disassembly involves removing the legs and arm supports.

Diagram G: Accessories

Available accessories include:

• 1. Potta Swift Commode incl. lid
• 2. Back support
• 3. Soft seat
• 4. Soft back
• 5. Soap dish/Lid support/Shower head holder
• 6. Toilet paper holder

Technical Data

Weight: 4.1 kg (9 lbs)

Maximum User Weight: 160 kg

Materials: PP, Alu, TPE, PE

Dimensions: (See Diagram D for detailed dimensions)

Installation

Ensure that the height difference between the chair legs does not exceed one hole adjustment.

Maintenance

Clean the device with a solvent-free detergent with a pH of 5-9, or with a 70% disinfectant solution. It can be decontaminated at a maximum of 85°C if required. The constituent materials are corrosion-resistant.

Warranty

5-year guarantee against material and manufacturing defects. For terms and conditions, see www.etac.com.

Storage

Store the device indoors in a dry place at a temperature above 5°C. If stored for more than four months, its function must be checked by an expert before use.

Declaration of Conformity

The device meets the requirements of the Medical Device Regulation (EU) 2017/745. It is tested and meets the requirements of EN ISO 10993-1, SS EN 12182.

Pre-purchase Information

Available at www.etac.com.

Adverse Event

In case of an adverse event, report it to your local dealer and the national competent authority promptly. The local dealer will forward the information to the manufacturer.

Customization

Any modification beyond the manual's instructions and settings voids Etac's CE marking and warranty. Consult Etac if you have any uncertainties regarding customization. Combination agreements may apply for devices coupled with other products; contact Etac for details.