PROTAC 300-302-V Incontinence Cover Instruction Manual

: June 8, 2024
: PROTAC

Table of Contents

Directions for use
General precautions – Safety
Product purpose and areas of use
Maintenance
Technical specifications
References
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300-302-V Incontinence Cover
Instruction Manual PROTAC 300 302 V Incontinence
Cover

Directions for use

Protac Incontinence Cover™
Protac Incontinence Cover™ with MESH
You have chosen a Protac quality product. Protac guarantees that you have purchased an original Danish designed product developed in partnership with professionals.
Since 1994, Protac has developed, manufactured and sold sensory stimulating aids to the healthcare sectors in Denmark, Europe, Australia and New Zealand.
Protac products are developed from the theory of sensory integration and are well documented with respect to research, documentation and case descriptions.
Protac production process focuses on environment and safety. The Protac Incontinence Cover™ is certified STANDARD 100 by OEKO-TEX® nr. 2076-310 DTI.
For more details, go to www.protac.dk
Labelling
The products are labeled in accordance with Regulation (EU) 2017/745 Class I medical devices.The label with details of manufacturer, raw materials and washing instructionsis placed inside the cover.
Key to label symbols: please refer to Key to symbols

General precautions – Safety

We recommend that the opening of the incontinence cover is at the opposite end to that of the duvet cover (not applicable for incontinence cover with mesh top)
The same risk precautions apply as for the use of a plastic bag:
– Protac Incontinence cover is a dangerous toy for children
– A Protac Ball Blanket® used with an incontinence cover must not be used for children without supervision.
– A Protac Ball Blanket® with incontinence cover must not be used for patients unable to care for themselves without supervision.
– A Protac Ball Blanket® used with an incontinence cover must not be pulled over the head.
We recommend using the incontinence cover version with a mesh top (a breathable, net panel) for users unable to care for themselves.
Must not be used near an open flame.

Incidents

Incidents related to the use of Protac Incontinence Cover™ must be reported to the manufacturer
Serious incidents related to the use of Protac Incontinence Cover™ must be reported to the manufacturer and the competent authority of the country where the incident takes place.

Product purpose and areas of use

The Protac Incontinence Cover™ was developed as an accessory for the Protac Ball Blanket®.
Children, young and old people can benefit from the cover.
The Protac Incontinence Cover™ is used to protect the Protac Ball Blanket® or other duvets in the event of patient incontinence.
Using the product
The cover is intended to fit over the Protac Ball Blanket® An ordinary duvet cover should be used over this. PROTAC 300 302 V Incontinence Cover -
Figure Product service life
The product has an expected service life of 5 years.
This is based on correct use, cleaning, washing, service and maintenance.
Products used beyond the aforementioned service life should be assessed for further use. Responsibility for using the product beyond the stated service life rests with the user.
Cleaning
All Protac Incontinence Covers can be washed. The regularity and need for washing depends on
use. See below for washing and cleaning instructions.

Incontinence cover, item no. 300-302 and 300-304 can be washed in a min. 6 kg capacity washing machine with detergent with no bleaching agents or perfume – see also the washing instructions in the cover.
Spot remover should not be used to avoid damage to the PU coating.
Protac cannot be held liable for incorrect washing and maintenance.

Maintenance

We recommend washing the cover regularly. Use of a laundry bag is recommended.
Transport and storage
The Protac Incontinence Cover™ is supplied in a sealed plastic bag. If you are not using the cover, store it carefully in its bag to protect from dirt and damp.
Disposal
The cover can be disposed of as combustible refuse.
Always dispose of refuse according to local rules.
Guarantee
2 year guarantee against manufacturing defects.
The guarantee will be invalid in the event of the following:

over-use
misuse
non-maintenance or incorrect maintenance

Traceability: Production month, year and batch number are marked on the CE- and care label.
Key to symbols
Example only. Always follow the recommended washing instructions on the label found inside the product
Washing bowl: Maximum washing temperature (see care label)
Triangle: Do not bleach
Square with a circle: tumble drying possible (see care label)
Iron: Do not iron
Circle: Do not dry clean
Warning: See under Safety
User information
For indoor use
CE marked according to (EU) 2017/745 for Class I medical devices
Manufacturer
Batch number

Technical specifications

Dimensions, Protac Incontinence Cover™:
Protac Incontinence Cover™, Adult:
Protac Incontinence Cover ™with MESH at the top, adult:
Protac Incontinence Cover™, Junior: Width: 100 cm Length: 140 cm
Protac Incontinence Cover™ with MESH at the top Junior:
Protac Incontinence Cover™ with MESH at the top Junior:
Width: 140 cm Length: 200/220 cm
Width: 140 cm Length: 200/220 cm
Width: 100 cm Length: 140 cm
Width: 100 cm Length: 140 cm
Standards: Comply with general requirements for aids acc. to the following harmonized standards:
EN ISO 13485:2016/A11:2021: Medical Devices – Quality management systems
EN ISO 14971:2019/A11:2021: Medical devices – Application of risk management to medical devices
DS/EN ISO 21856:2022 : Medical devices – Assistive products – General requirements and test methods.
Ignitability test:
Style 300-302 comply with ISO 12952 part 1 & 2 : 2010.
Model 300-304 is made of polyester with PU coating and polyester MESH net on the top – this model is not flame retardant.
Guide
– to daily inspection of the Protact Incontinence Cover™ before use

All parts are in place, no loose parts
No sign of holes, damage to the textile or seams

Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Tel.: +45 86 19 41 03
e-mail: protac@protac.dk
Distributor list: Please refer to: www.protac.dk/kontakt

Medical Device
5.7.1.1 – Incontinence Cover – August 2022 – Vers. 8
www.protac.dk