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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF076-02-TechInfo Edition: 02 REF Number
8012
Product Name Provox® Adhesive Remover Models: 1 model Classification: (MDD 93/42/EEC)
I (1.1 Rule 1)
CE Mark: Yes GMDN code: 60494 (Medical adhesive remover, non-sterile) EAN code: REF Description EAN code
8012 Provox Adhesive Remover (50 pcs) 7331791009235
Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: Provox Adhesive Remover is a single use wipe to help laryngectomized
patients remove Provox Adhesives and Provox Silicone Glue. Description: Provox Adhesive Remover contains a sting free solvent that helps
laryngectomized patients remove Provox Adhesives and Provox Silicone Glue.
Sterilization: Non-sterile Raw material: Cloth: Polyester and Viscous fabric
Solution: Hexamethyldisiloxane, Isopropyl-myristate. Latex information:
Not manufactured with natural rubber latex.
Biological origin:
The device is not manufactured with any materials derived from human or animal source.
Handling and storage:
Keep dry and away from sunlight. Temperature limit 2 - 42°C.
Issued: DD Alexandra Holmberg - ALEHOL 2018-11-26 - 15:59Reviewed: QA John Wennborg - JOHWEN 2018-11-27 - 10:56Approved: DD Mikael Melefors - SEHRBSGM 2018-11-29 - 20:03Released: DD Alexandra Holmberg - ALEHOL 2019-01-02 - 09:51
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
Please read the instruction for use or consult the Material Safety Data Sheet (MSDS) before handling for safe use, physical and health hazard information. The MSDS is not included with the product packaging, but can be obtained by contacting Atos Medical AB.
Expiration date:
3 years after manufacturing
Packaging: 1 wipe in a bag and 50 bags in one box.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF080-01-Techinfo
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF080-01-Techinfo Edition: 02 REF Number
8015
Product Name Provox Adhesive Strip Models: 1 model: Provox Adhesive Strip Classification: (MDD 93/42/EEC)
Class I (1.1 Rule 1)
CE Mark: Yes GMDN code: 62175 (U)DI code: 7331791009525 Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: Provox Adhesive Strip is a single use device to seal Provox adhesives, e.g.
during showering. Description: The Provox Adhesive Strip is developed to be used as a seal for the Provox
adhesives, e.g. during showering or when leakage from the adhesive develops.
Sterilization: Non-sterile Raw material: Adhesive: Hydrocolloid, Polyethylene (PE)
Liner: Super calendered glassine paper with siliconized surface Liner finger lift: Polyethylene (PE)
Latex information: Not manufactured with natural rubber latex Biological origin: The device is not manufactured with any materials
derived from human or animal source.
Handling and storage:
Keep dry and away from sunlight. Temperature limit: 2-42 °C.
Issued: DD Charlotta Lagerblad - CHALAG 2016-11-15 - 09:48Reviewed: QA Marie Lange - SEHRBLEM 2016-11-15 - 10:32Approved: DD Mikael Melefors - SEHRBSGM 2016-11-17 - 09:35Released: DD Charlotta Lagerblad - CHALAG 2016-12-01 - 11:18
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF080-01-Techinfo
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
None
Expiration date: 3 years after manufacturing Packaging: 10 Provox Adhesive Strip in a blister will be packed in one paper box.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF018-01-TechInfo
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF018-01-TechInfo Edition: 06 REF Number
7263
Product Name Provox® BasePlate Adaptor Models: 1 model Classification: (MDD 93/42/EEC)
I (1.1 Rule 1)
CE Mark: Yes GMDN code: 58705 (Tracheostoma protective filter) (U)DI code: 7331791001697 Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: The Provox BasePlate Adaptor (“adaptor”) is an accessory product for
rehabilitation after total laryngectomy. It allows attaching medical devices, (HME), with ISO 15mm standard connector to a tracheostoma by fitting it into a Provox Adhesive base plate, Provox LaryButton or Provox LaryTube. A typical example would be to attach an HME with built-in oxygen adapter (TrachPhone). For single patient use.
Description: Provox BasePlate Adaptor facilitates the use of TrachPhone together with
Provox Adhesives or Provox LaryTube. Sterilization: Non-sterile Raw material: PEEK Latex information: Not manufactured with natural rubber latex Biological origin: The device is not manufactured with any materials
derived from human or animal source.
Handling and storage:
Standard 22°C ± 20 °C, 45% rH ± 35% rH, not direct sunlight.
Issued: DD Mårten Cervin - SEHRBCNM 2018-08-30 - 12:04Reviewed: QA John Wennborg - JOHWEN 2018-08-30 - 14:25Approved: DD Daniel Åberg - DANABE 2018-08-31 - 10:47Released: DD Mårten Cervin - SEHRBCNM 2018-09-05 - 09:26
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF018-01-TechInfo
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
None
Expiration date: 5 years after manufacturing Packaging: BasePlate Adaptor is separately packed in a plastic bag and together
with instructions for use in a cardboard box.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF034-01-TechInfo Edition: 05 REF Number
7244
Product Name Provox® Cleaning Towel Models: 1 model Classification: (MDD 93/42/EEC)
I (1.1 Rule 1)
CE Mark: Yes GMDN code: 46205 (Secretion/excreta skin cleanser) EAN code: REF Description EAN code
7244 Provox Cleaning Towel (200 pcs per box) 7331791001536
Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: Provox Cleaning Towel is intended for cleaning around the stoma, it will
remove oil from the skin. They are indented to use before application of Provox Adhesives.
Description: Provox Cleaning Towel is alcohol-based and non-perfumed and is available
in resealable poaches. Sterilization: Non-sterile Raw material: Towel: Spunlaced viscose, Polyester
Solution: Chlorhexidine, Ethanol, BTC 2125, deionised water. Latex information:
Not manufactured with natural rubber latex.
Biological origin:
The device is not manufactured with any materials derived from human or animal source.
Handling and storage:
Keep dry and away from sunlight. Temperature limit: 2-42 °C
Waste Waste handling and disposal should be carried out in agreement with
Issued: DD Alexandra Holmberg - ALEHOL 2018-11-20 - 15:43Reviewed: QA John Wennborg - JOHWEN 2018-11-20 - 20:54Approved: DD Mikael Melefors - SEHRBSGM 2018-11-29 - 20:01Released: DD Alexandra Holmberg - ALEHOL 2019-01-02 - 09:50
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
handling and disposal:
medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
The product contains ethanol (concentrated ethanol is flammable) and chlorhexidine (concentrated chlorhexidine may cause eye damages if in contact with the eyes).
Expiration date:
2 years after manufacturing
Packaging: 10 towels in every bag, 20 bags in every cardboard box.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF038-01-TECHINFO Edition: 05 REF Number
7246
Product Name Provox HME Cassette Adaptor Models: 1 model, for cannulas with 15 mm ISO connection Classification: (MDD 93/42/EEC)
I (1.1 Rule 1)
CE Mark: Yes GMDN code: 58705 (Tracheostoma protective filter) EAN code: REF Description EAN code
7246 Provox HME Cassette Adaptor 7331791001543
Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: The Provox HME Cassette Adaptor is intended to facilitate a connection
between Provox HME Cassette and on the market available tracheal cannulas with ISO-cone (15mm).
Description: Laryngectomy For laryngectomies who need a cannula initially or for a longer period of time. Enables immediate start of pulmonary rehabilitation with HME.
Sterilization: Non-sterile Raw material: Silicone Latex information:
Not manufactured with natural rubber latex.
Biological origin:
The device is not manufactured with any materials derived from human or animal source.
Handling and storage:
Standard 22°C ± 20°C, 45% fH ± 35% rH, not direct sunlight.
Issued: DD Alexandra Holmberg - ALEHOL 2018-11-20 - 14:59Reviewed: QA John Wennborg - JOHWEN 2018-11-20 - 20:50Approved: DD Mikael Melefors - SEHRBSGM 2018-11-29 - 20:00Released: DD Alexandra Holmberg - ALEHOL 2019-01-03 - 09:09
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
None
Expiration date:
5 years after manufacturing
Packaging: 1 Cassette Adaptor in a plastic bag.
1 IFU
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF077-02-Techinfo
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF077-02-Techinfo Edition: 03 REF Number
8014
Product Name Provox® LunaTM Adhesive Models: 1 model: Provox Luna Adhesive (15 pcs) Classification: (MDD 93/42/EEC)
Class I (1.1 Rule 1)
CE Mark: Yes GMDN code: 62175 (U)DI code: 7331791009259 Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: The Provox Luna Adhesive is a skin-friendly, single use adhesive that
provides attachment for the Provox Luna HME for night-time use after total laryngectomy.
Description: Before the adhesive is attached to the skin the adhesive liner is removed.
Provox Luna HME or Provox Luna ShowerAid can be attached to the adhesive.
Sterilization: Non-sterile Raw material: Adapter: TPE
Carrier: Polyurethane film Adhesive: Hydrogel, siliconised PET liner
Latex information: Not manufactured with natural rubber latex Biological origin: The device is not manufactured with any materials
derived from human or animal source.
Handling and storage:
Keep dry and away from sunlight. Temperature limit: 2-30°C
Issued: DD Mårten Cervin - SEHRBCNM 2017-07-12 - 15:49Reviewed: QA Karolina Nilsson - KARNIL 2017-07-12 - 16:31Approved: DD Mikael Melefors - SEHRBSGM 2017-07-12 - 17:48Released: DD Mårten Cervin - SEHRBCNM 2017-07-13 - 14:20
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF077-02-Techinfo
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
None
Expiration date: 3 years after manufacturing Packaging: Each adhesive is packed in an aluminum bag and 15 adhesives and an
IFU are packed in a paper box.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF079-01 TechInfo
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF079-01 Edition: 02 REF Number
8016
Product Name Provox Luna ShowerAid Models: One model Classification: (MDD 93/42/EEC)
I (1.1 Rule 1)
CE Mark: Yes GMDN code: 62047 (U)DI code: 7331791009532 Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: The Provox Luna ShowerAid is used with the Provox Luna Adhesive while
taking a shower to avoid water from entering the stoma. Single patient use.
Description: The Provox Luna ShowerAid is used with the Provox Luna while taking a
shower to avoid water from entering the stoma. Sterilization: Non-sterile Raw material: Polypropylene (PP) with white masterbatch Latex information: Not made with natural rubber latex Biological origin: The device is not manufactured with any materials
derived from human or animal source.
Handling and storage:
Upon storage, keep dry and away from sunlight. Temperature limit: 2-42 °C.
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Issued: DD Diana Tieger - DIATIE 2016-11-15 - 14:04Reviewed: QA Marie Lange - SEHRBLEM 2016-11-15 - 15:17Approved: DD Mikael Melefors - SEHRBSGM 2016-11-17 - 09:36Released: DD Charlotta Lagerblad - CHALAG 2016-11-28 - 12:58
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 07 Valid from: 2016-10-24 File name: PF079-01 TechInfo
Hazardous components:
None
Expiration date: 3 years after manufacturing Packaging: The Provox Luna ShowerAid is packed in a plastic bag and then together
with instructions for use in a cardboard box.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF020-01-Techinfo Edition: 08 REF Number
7260
Product Name Provox® ShowerAid Models: 1 model Classification: (MDD 93/42/EEC)
I (1.1, Rule 1)
CE Mark: Yes GMDN code: 62047 (Tracheostoma shower shield) EAN code: REF Description EAN code
7260 Provox ShowerAid 7331791001680
Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: The Provox ShowerAid is used to temporarily replace the Provox
XtraMoist/Provox XtraFlow/Provox FreeHands/Provox FreeHands FlexiVoice/Provox Micron HME during showering. The device is for single patient use.
Description: Shower protection device. Use together with Provox appliance holders Sterilization: Non-sterile Raw material: Polypropylene (PP) with blue masterbatch Latex information: Not manufactured with natural rubber latex Biological origin: The device is not manufactured with any materials
derived from human or animal source.
Handling and storage:
Keep dry and away from sunlight. Temperature limit 2 - 42°C.
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Issued: DD Alexandra Holmberg - ALEHOL 2018-12-18 - 11:55Reviewed: QA John Wennborg - JOHWEN 2018-12-20 - 11:21Approved: DD Mikael Melefors - SEHRBSGM 2018-12-21 - 10:50Released: DD Alexandra Holmberg - ALEHOL 2019-01-03 - 09:09
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Hazardous components:
None
Expiration date: 3 years after manufacturing. Packaging: The Shower Aid is packed in a plastic bag that is packed together with
instructions for use in a cardboard box also including one piece of Provox FlexiDerm Oval.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Justification Function: Signature: Date: Issued by: Reviewed by: Approved by: Released by:
Document ID: PF076-01-TechInfo Edition: 02 REF Number
8011
Product Name Provox® Skin Barrier Models: 1 model Classification: (MDD 93/42/EEC)
I (1.1 Rule 1)
CE Mark: Yes GMDN code: 58978 (Synthetic-polymer liquid barrier dressing, non-sterile) EAN code: REF Description EAN code
8011 Provox Adhesive Remover (50 pcs) 7331791009235
Produced by: Atos Medical AB
Kraftgatan 8 P.O. Box 183 242 22 Hörby Sweden
Intended Use: Provox Skin Barrier is a single use wipe for laryngectomized patients that forms
a barrier between Provox Adhesive and the skin Description: Provox Skin Barrier contains a sting free solvent that is wiped on skin providing
a barrier between Provox adhesive and the skin. Sterilization: Non-sterile Raw material: Cloth: Polyester and Viscous fabric
Solution: Hexamethyldisiloxane, Isopropyl-myristate and Trimethylsiloxysilicate. Latex information:
Not manufactured with natural rubber latex.
Biological origin:
The device is not manufactured with any materials derived from human or animal source.
Handling and storage:
Keep dry and away from sunlight. Temperature limit 2 - 42°C.
Issued: DD Alexandra Holmberg - ALEHOL 2018-12-18 - 15:42Reviewed: QA John Wennborg - JOHWEN 2018-12-20 - 11:32Approved: DD Mikael Melefors - SEHRBSGM 2018-12-21 - 10:50Released: DD Alexandra Holmberg - ALEHOL 2019-01-02 - 09:51
This document has been electronically signed by the persons above.
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Quality Management System
Technical Info / Material Data Sheet
This document is a property of ATOS MEDICAL AB, Sweden. It is not to be used or duplicated without written permission of the owner, and is not to be used in any way inconsistent of the purpose for which it is lent. Document No.: QMC-730-115-en Issue No.: 08 Valid from: 2018-10-04
Waste handling and disposal:
Waste handling and disposal should be carried out in agreement with medical practice and applicable national laws and legislations. Used product may be a potential biohazard.
Hazardous components:
Please read the instruction for use or consult the Material Safety Data Sheet (MSDS) before handling for safe use, physical and health hazard information. The MSDS is not included with the product packaging, but can be obtained by contacting Atos Medical AB.
Expiration date:
3 years after manufacturing
Packaging: 1 wipe in a bag and 50 bags in one box.
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