MOBIAKCARE 0808511 Waterproof Covers for Arms and Legs User Manual

MOBIAKCARE 0808511 Waterproof Covers for Arms and Legs

Product Information

Specifications

• REF : 0808511 – 22” (56 cm) Waterproof Arm Cover (Adult 22 inches/56 cm)
• REF : 0808512 – 18” (45.72 cm) Waterproof Arm Cover (Child 18 inches/45 cm)
• REF : 0808513 – 23” (58.4 cm) Waterproof Leg Cover (Adult 23 inches/58 cm)
• REF : 0808514 – 18” (45.72 cm) Waterproof Leg Cover (Child 18 inches/45 cm)

Product Usage Instructions

1. Preparation: Before using the waterproof cover, ensure the area to be covered is clean and dry.
2. Putting on the Cover: Slide the cover gently over the arm or leg, ensuring a snug fit but without causing discomfort.
3. Securing: Make sure the cover is securely in place to prevent water from entering.

Intended Use
This product is designed to be used as a waterproof protector for plasters or bandages during shower or bath time.

Incident Reporting
In case of any serious incidents related to the use of this product, it is important to report them to the manufacturer and the relevant authorities in the user’s residing country.

FAQ

1. Q: How should I clean the waterproof covers?
   A: To clean the covers, gently wipe them with a damp cloth using mild soap. Avoid harsh chemicals or abrasive materials.

2. Q: Can these covers be reused?
   A: Yes, the waterproof covers are reusable. Make sure to clean and dry them properly after each use for longevity.

USER MANUAL: WATERPROOF COVERS FOR ARMS/LEGS

• REF: 0808511
  • ΚΑΛΥΜΜΑ ΑΔΙΑΒΡ. ΕΝΗΛ.ΧΕΡΙΟΥ 22’’ (56 cm) WATERPROOF ARM COVER ( ADULT 22INCHES/56 cm)
• REF: 0808512
  • ΚΑΛΥΜΜΑ ΑΔΙΑΒΡ. ΠΑΙΔ.ΧΕΡΙΟΥ 18’’ (45,72 cm) WATERPROOF ARM COVER (CHILD 18INCHES/45 cm)
• REF: 0808513
  • ΚΑΛΥΜΜΑ ΑΔΙΑΒΡ. ΕΝΗΛ.ΠΟΔΙΟΥ 23’’ (58,4 cm) WATERPROOF LEG COVER ( ADULT 23INCH/58 cm)
• REF: 0808514
  • ΚΑΛΥΜΜΑ ΑΔΙΑΒΡ. ΠΑΙΔ.ΠΟΔΙΟΥ 18’’ (45,72 cm) WATERPROOF LEG COVER (CHILD 18INCH/45 cm)

INTENDED USE

This product is intended to be used as a waterproof plaster or bandage protector in the shower or bath.

IMPORTANT:

• Before use, lightly file any sharp edges of the plaster that may pierce the protector.
• Hold the plastic ring firmly, and then place the hand or foot that have the plaster or bandage inside.
• Make sure the protector adequately covers the plaster or bandage,
• Dry the plastic ring before removing the protector.
• When removing the protector, hold it by the plastic ring and not by the PVC bag as product failure may be caused
• The product is intended for single patient use.

CAUTION :

• Do not use sharp objects in the product.
• Protect the product from abrasions, cuts and holes
• Plastic ring is not designed to have heavy weight applied to it.
• The protector can become slippery while wet, as the surroundings in the shower area. Use extreme caution when bathing or showering in these conditions.
• Make sure the ring is not too tight in the arm or leg area. Consult your doctor if the ring causes swelling or discomfort.

INCIDENT REPORTING

Any serious incident that occurs in relation to use of the device must be reported to the manufacturer and a competent authority of the Member State in which the user and / or patient resides.

ENVIRONMENTAL PROTECTION

If one day you find that your product needs to be replaced or it is no longer working for you, consider protecting the environment:

1. Do not dispose your product along with the rest of the public waste (this is also the meaning of the shown recycling sign).
2.  Contact your Public Authorities and they will instruct you of the Recycling centers to which your product must be disposed.
3. Correct disposal of your product helps the protection of the environment as well as the recycling of the products’ components.

Valentine International Ltd. gth Floor, No. 149, Sec 2, Ta Tung Road 221 Hsichih District, New Taipei City Taiwan R.O.C.
MOBIAK S.A KATHIANA AKROTIRIOU CHANIA, CRETE-GREECE T:+30 28210 63222

Valentine international Ltd.

• Floor, No. 149, sec. 2,
• Ta Tung Road, 221 H:Sichih District,
• New Taipei City, Tliwan R.O.C.
• Tel: +886.2.8692.6662
• Fax :+8&6..2.8692.6660
• info@valentine-dynalife.com

Declaration of Conformity

• Manufacturer:
  • Valentine International Ltd.
  • 221 Hsichih District, New Taipei Oty
  • Taiwan R.O.C.
• SRN: TW·MF·000011689
• Authorized Representative

SRN: DE·AR-000005142

• hereby declare that the products specified above are classified as class 1 devices, as in conformity with the requirements of the EU Medical Device Regulation (EU) MDR 2017/ 745.

• This was verified with conformity evaluat ion procedures according to Medical Device Regulat ion Annex VIII.

• Products — Meet requirements for MDR regulation 2017 /745

• This is certify Quality System ISO 13485: 2016,
  CERTIFICATED NUMBER 217412-2017-AQ·RGC· NA·PS Rev. 2.0

• Authorized signature:

• Ivory Hung/ Manager June 26 2023

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