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Summary of Contents for DEHAS QualityFlow
- Page 1 Operating Instructions DEMAND VALVE QualityFlow (Picture shows a demand valve with connected O2 hose) 0482 Keep these instructions! Phone: (+49) 451 80904-0 DEHAS Medical Systems GmbH Fax: (+49) 451 80904-111 Wesloer Straße 107-109 www.DEHAS.de 23568 Lübeck OT Schlutup, Germany Version 3.2.
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Page 2: Table Of Contents
Content Preface ............................2 Basic Requirement ........................2 Intended use ..........................2 Accessoires / Variants ......................2 Applied standards ........................3 Safety Information – Warning, caution and labeling information ..........3 Before first of use .......................... 5 Safety Information ........................5 Technical data .......................... -
Page 3: Preface
1 Preface These operating instructions are intended to provide you with assistance in using the QualityFlow demand valve. The operating instructions are divided into individual chapters. Please note: Read these instructions for use carefully and completely before using the product for the first time. -
Page 4: Applied Standards
2.3 Applied standards The product complies with the essential requirements according to Annex I of Directive 93/42/EEC (Medical Device Directive) as well as the applicable national regulations such as the Medical Devices Act (MPDG). Standard / Norm Title DIN EN ISO 780 Packaging - Shipping packaging - Graphical symbols for handling and storage of packages DIN EN ISO 15223-1... - Page 5 Manufacturer Date of manufacture Keep dry / Protect from moisture Unique Device Identifier Medical device Serial number Reference number / Article number Product non-sterile Temperature limit Indicates the permissible upper and lower air pressure limits for transport and storage. Humidity limitation for storage Refers to the need for the user to consult the instructions for use.
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Page 6: Before First Of Use
Follow the instructions for use Do not dispose of in household waste Do not use if the packaging is damaged DO NOT USE OIL Authorized Representative CH Authorized Representative UK 4 Before first of use Read all instructions before use! These operating instructions provide qualified personnel with instructions for installation and operation. - Page 7 the sole responsibility of the medical personnel. The housing of the demand valve must never be opened by the user by unscrewing. To assemble or disassemble the adapters intended for the product, please follow the instructions in Chapter 6 of this manual. ...
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Page 8: Technical Data
Cleaning! NOT suitable for sterilization. Never immerse the entire demand valve in liquids. 5 Technical data Product Demand Valve QualityFlow O2 Klassifikation nach Medizinproduktrichtlinie Class IIb 93/42/EWG Requirements According to DIN EN ISO 5359 and DIN EN ISO... -
Page 9: Design And Function
Filter 25 microns Transport / Storage temperature in original -20°C to +40°C packaging Marking Serial number, LOT (adapter), GTIN / UDI, CE marking, date of manufacture, expiration date (hose), safety symbols 5.1 Design and function ① ② Explanation / Designation ①... -
Page 10: Putting Into Service
6.1 Putting into service Product inspection: Before first use, the product must be cleaned/wiped disinfected (see Chapter 7). Check that the product is functional and free from contamination or damage. Ensure that the supply hose connected to the demand valve is attached to a medical oxygen supply using the appropriate medical gas connection. -
Page 11: On The Cylinder Supply → Ventilation Bag
6.3.2 on the cylinder supply → Ventilation bag Step Activity Connect the demand valve by attaching the outlet connection (M12x1, 9/16, or Rectus coupling) to the inlet connection of the O₂ hose. Then, connect the outlet connection of the O₂ hose (M12x1 or DIN 13260 plug) to an O₂ pressure regulator on the oxygen cylinder, which provides a pressure of 400 to 500 kPa (4-5 bar). -
Page 12: After Use / Decommissioning
6.4 After use / decommissioning 6.4.1 Disassembly from the cylinder supply → Resuscitator bag Step Activity Close the valve of the O2 cylinder and disconnect the connecting hose with the outlet connection from the pressure reducer of the O2 cylinder. Pull the demand valve out of the suction opening of the ventilation bag. -
Page 13: Disassembly From The Central Gas Supply → Ventilation Bag
Prepare the demand valve according to the cleaning and care instructions. 6.4.3 Disassembly from the central gas supply → Ventilation bag Step Activity Uncouple the connecting hose from the O2 coupling of the central gas supply. Please follow the instructions of the manufacturer of the corresponding tapping point socket for disconnecting the plug! Pull the demand valve out of the suction opening of the ventilation bag. -
Page 14: Cleaning Instructions
DO NOT use strong solvents or abrasives. DO NOT clean with aromatic hydrocarbons. 7.1 Cleaning and Disinfection Manufacturer: Sterilization method: DEHAS Medical Systems GmbH Wesloer Str. 107-109 The product is not 23568 Lübeck, OT Schlutup, intended for Germany sterilization process. - Page 15 Filter (HME filter / disposable) Ventilation bag DEHAS adapter (reusable) Check the corresponding manufacturer's instructions to determine whether the used accessories are disposable or reusable. Disposable items: Dispose of them properly. Reusable items: Ensure that a validated cleaning and disinfection method is in place that...
- Page 16 Cleaning and disinfection of the QualityFlow O2 demand valve: Step Description Execution Coarse Cleaning Removal of dust and visible dirt. Wipe off coarse contamination with a soft, water-moistened, lint-free cloth. Mild Cleaning Agent Remove stubborn dirt. If necessary, use a mild cleaning agent (e.g., water-based).
- Page 17 Cleaning and disinfection of adapters as accessories of the demand valve: Preparation for cleaning and disinfection: Disconnect the adapter from the demand valve (see chapter 6.4.1) Step Description Execution Manual Cleaning Removal of dust and visible dirt. Wipe off coarse contamination with a soft, water-moistened, lint-free cloth.
- Page 18 Storage of Product Safe storage of the device. Store or transport the product in DEHAS validated packaging. After each cleaning and disinfection, a visual and functional inspection must be carried out. The demand valve is subject to natural wear and tear after repeated manual cleaning and disinfection.
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Page 19: Inspection & Maintenance
8 Inspection & maintenance 8.1 General Maintenance, repairs and periodic inspections may only be carried out by persons who have the appropriate expertise and are familiar with the product. However, the product must be cleaned regularly after use, visually inspected for signs of damage and its performance checked. -
Page 20: Leak Test
Step Description Evaluation: The demand valve should immediately stop the gas flow when not in use or when the patient/test lung stops inhaling. If gas continues to flow, even slightly, it may indicate a malfunction, and the valve may need to be checked, adjusted, or replaced. 8.2.2 Leak test Connect the demand valve to the pressure reducer and open the gas supply to the O2 cylinder. - Page 21 At the end of the service life: Have the demand valve disposed of properly after consulting the relevant disposal company. Observe the applicable legal regulations.
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Page 22: Manufacturer Information
12 Manufacturer Information Manufacturer DEHAS Medical Systems GmbH Wesloer Straße 107-109 23568 Lübeck Germany Tel: 0451/80904-0 Fax: 0451/80904-111 Email: Info@dehas.de Homepage: www.dehas.de Authorized Representatives Distributed by: Rev. 3.2. Stand 01/2025...
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