etac 78644 Clean shower commode User Manual

: June 1, 2024
: Etac

Table of Contents

etac 78644 Clean shower commode
Product Information
Product Usage Instructions
General
Device description
Technical data
Handling
Settings
Service and maintenance
Transport, storage and disposal
Accessories
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

etac 78644 Clean shower commode

Product Information

Specifications

Model: Clean 24
Height adjustable
Manufacturer: Etac
Website: www.etac.com

Product Usage Instructions

Device Description
The Clean 24 is a height-adjustable cleaning device designed and manufactured by Etac. It is equipped with various settings for optimal use.

Handling
Ensure the device is securely set at the desired height before use. Use the device as instructed to effectively clean the intended surface.

Service and Maintenance
Regularly clean the device after each use to maintain hygiene standards. Follow manufacturer guidelines for any maintenance or servicing needs.

Transport, Storage, and Disposal
When not in use, store the Clean 24 in a dry and safe place.
Dispose of the device responsibly following local regulations if necessary.

FAQ (Frequently Asked Questions)

Q: How do I adjust the height of the Clean 24?
A: To adjust the height, locate the height adjustment mechanism on the device and follow the provided instructions in the user manual.

Q: Can I use cleaning agents with the Clean 24?
A: It is recommended to use mild cleaning agents suitable for the surfaces being cleaned. Avoid harsh chemicals that may damage the device.

General

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.

Item list: = Applies to, = Accessories

See the item list on the right which displays the information applicable to each product.

The images which are referred to on each page are found at the start of the manual (pages 3 to 9). See Figures A to F for the corresponding text.

Device description
The Clean family is a range of mobile shower commode chairs whereof Clean and Clean Height adjustable are assistant propelled and Clean 24” can be propelled by the user.

Intended purpose
Clean, Clean 24” and Clean Height adjustable (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 be used when performing hygiene tasks in the shower, at a sink, or over the toilet, as well as for transfers to and from the hygiene room.

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 for use with intact skin. The device is intended for refurbishment and reuse.

Expected service life
The expected service life is 7 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 physical disabilities who needs backrest and/or armrests to maintain a sitting position and assistance with transfers to/from the chair.

Contra indications:
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.

Check user sensitiveness for pressure ulcer before use
A defective device must not be used.
Heated device can cause burns
Body parts may get squeezed while applying or removing the pan
Ignoring installation or assembly instructions may result in injury.

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

See figure A

$etac-78644-Clean-shower-commode-FIG- $1$$

A1. Back support A2. Arm support A3. Seat A4. Foot support A5. Castor A6. Product label (warnings, CE-marking) A7. Item number label (ser.no., production date) A8. Rear wheel A9. User brake A10. Height adjustment

Symbols, labels

$etac-78644-Clean-shower-commode-FIG- $2$$

$etac-78644-Clean-shower-commode-FIG- $3$$

Symbols in the manual and on the device:
B1. Warning, precaution or limitation. B2. Useful advise and tips. B3. Material for recycling. B4. The part/function is locked and can not be moved/adjusted. B5. Pinch point! B6. Tool box-end spanner B7 Max user weight (see techni-cal data). B8. Video B9-B10. Cleaning (see service and maintenance). B11. Do not stand on the footrest, risk of tipping. B12. Seating position affects the stability.
B13. Risk of pinching at the arm support. B14. Product weight

Information on item no label:
B15. Product name. B16. Product description.
B17. Serial number. B18. Item number.
B19. Production date. B20. Bar code acc. to GS1-128 GTIN-14 and serial no.*
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

See figure C

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$etac-78644-Clean-shower-commode-FIG- $5$$

$etac-78644-Clean-shower-commode-FIG- $6$$

Handling

See figure D

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Installation upon delivery D1-D2

Transfer over a threshold:
D3

Chair only, push down on the wheel attachment.

With user, pull the chair backwards. D4

Make sure the castors are locked when the user sits down or gets up from the chair.

In stationary position:
Always lock as many castors as possible when the chair is to be used in a stationary position. D5

Out-turned castors improve the chair’s stability.

Transferring: D6
Assess the risks and take notes. You as a carer are responsible for the safety of the user. Aids should be used if the transfer is deemed as risky. Visit www.etac.com for manual transfer aids.

$etac-78644-Clean-shower-commode-FIG- $8$$

It is important to ensure that the castors are locked and pointing outward before carrying out transfers to and from Clean. Remove the armrest on the transfer side of the chair.

Carry out the transfer. D5-D10

Arm supports:

The arm supports are swing away and detachable. D11
The arm supports are lockable. D12

Do not lean on just one armrest.

Foot supports:

The carer can easily push in the foot support with their foot. D13
The foot support is detachable. D14

Do not stand on the footrest

Settings

See figure E

$etac-78644-Clean-shower-commode-FIG- $9$$

Height adjustment:
The height can be adjusted with ease by placing the screw in the required position. E1-E2

Check that all four castors are similarly adjusted, otherwise stability will be reduced.

Check so that wing nuts are in place

Foot supports:
The foot support has 4 different angle and height settings. E3

The foot support has 8 different angle and height settings. E4

More adjustment options are available by moving the pin. E5

User may be grazed by the footrest supporting pin when the footrest is removed

When the chair is adjusted to a height of 47.5 cm, the lowest footrest position must not be used.

$etac-78644-Clean-shower-commode-FIG- $10$$

$etac-78644-Clean-shower-commode-FIG- $11$$

Back support upholstery E6-E9

User brake E10-E12

Risk of pinching at rear wheel and chassis/brake.

Service and maintenance

Clean the device using a standard non-abrasive cleaning agent (pH between 5 and 9). Rinse and dry.
Disinfect the device with 70% disinfectant solution.
The device requires no other maintenance.
The device and its accessories can be safely cleaned at 85°C for 3 minutes (unless otherwise stated). This applies to reconditioning.
Constituent materials are resistant to common disinfectants.
The following surface treatment methods have been used to protect against corrosion:

Lacquered surfaces = Polyester powder coating Non-lacquered steel surfaces = Fe/Zn-Ni 5-year guarantee against material and manufacturing defects. For terms and conditions, see www.etac.com.

Transport, storage and disposal

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.