PROACT Smoothline Laryngoscope Handles & Blades Smoothline™ Fibre Optic - Compatible with ISO 7376-3 Green System Fibre Optic Instructions For Use WARNINGS PRE-USE CHECKS Tracheal intubation requires specialist training. Only competent trained personnel should use this device. Do not use this device unless the following checks have been performed. •Avoid exposure to ultraviolet or direct sunlight. •Ensure that used batteries are disposed of in accordance with appropriate national and local laws, regulations and procedures. regulations and procedures. •This device is not suitable for use in a Magnetic Resonance Imaging (MRI) environment. •Remove batteries from handles when not in use. •Check device for completeness, sharp edges, damage, flaws or loose components. •Engage and disengage laryngoscope twice prior to use to confirm operation, ensure consistent light when force is exerted on blade tip in all directions. •Insufficient, flickering or absence of light may indicate that batteries require replacing or a problem with the bulb or handle contact. •Inspect optic light source for clarity. Light output may degrade over time from repeated autoclaving. Quality is guaranteed for 300 cycles. •In event of pre-use check failure return product to supplier for inspection. DIRECTIONS FOR USE CLEANING INSTRUCTIONS These directions are general guidelines intended for use by qualified medical personnel. Any instructions and contraindications given are not exhaustive and it is the responsibility of the clinician to ensure the safe, correct use of this product. •Select the appropriately sized device for patient. •Unscrew cap at base of handle to insert fresh batteries observing correct polarity (see diagram). •Attach laryngoscope blade to compatible handle. •Ensure blade is fitted firmly onto handle and clicked into place. •To switch on, pull blade up and lock into position. Light will activate automatically. •Examine / intubate trachea following current accepted medical guidelines. •To switch off, move blade down. Light will automatically turn off. Battery Polarity Infection from patient to patient can potentially be transmitted by any piece of medical equipment. Sufficient measures must be taken to clean, disinfect and sterilise (where appropriate) this device between uses. Laryngoscope Blades • Clean externally with a damp cloth using soap, alcohol or disinfectant solution to remove any deposits. • Observe manufacturer’s usage instructions for all cleaning substances. • pH neutral cleaning solutions recommended. Avoid caustic ingredients. • Device may be autoclaved up to a maximum of 138°C for periods in compliance with national recommendations. Guaranteed for 3,000 5-minute cycles. • Suitable for sterilisation by Ethylene Oxide (ETO), Steris or Sterrad procedures. • Do not use abrasive cleaning techniques. • Do not flash autoclave. • Do not ultrasonically clean. Laryngoscope Handles • Remove batteries. • Clean externally with a damp cloth using soap, alcohol or disinfectant solution to remove any deposits. • Observe manufacturer’s usage instructions for all cleaning substances. • pH neutral cleaning solutions recommended. Avoid caustic ingredients. • Ensure that fluid does not seep into the electrical contact area. • Suitable for sterilisation by Ethylene Oxide (ETO), Steris or Sterrad procedures. • Ensure that handle is dry both inside and out prior to storage. • Do not immerse handles in disinfectant or washing solutions. • Do not use abrasive cleaning techniques. • Do not autoclave. • Do not ultrasonically clean. Manufactured for: PROACT Medical Ltd 9-13 Oakley Hay Lodge, Great Folds Road, Oakley Hay Business Park, Corby, Northants, NN18 9AS, UK Tel: +44 (0)1536 461981 E-mail: sales@proactmedical.co.uk PROACT Medical SAS Parc d’Activitiés des Béthunes, 8 Avenue du Fief Lot No 9, BP 20424 Saint Ouen l’Aumône, 95005 Cergy Pointoise Cedex, France Tel: +33 (0) 1.34.42.95.32 E-mail: ventes@proactmedical.fr IFU 203 - v1 1/2 TECHNICAL INFORMATION AND RE-ORDERING CODES wC All Smoothline Laryngoscopes comply with ISO 7376:2009 where applicable. Smoothline Laryngoscope Blades, Green System Fitting, Polished Finish Smoothline Laryngoscope Handles, Green System Fitting Part Number H9020P H9021P H9022P H9023P H9024P H9025P H9029P H9030P H9031P H9032P H9033P Part Number H4551 H4552 H4553 Style Macintosh Macintosh Macintosh Macintosh Macintosh Macintosh Miller Miller Miller Miller Miller Size 0 1 2 3 4 5 00 0 1 2 3 Blade Length 58.0mm 72.0mm 88.0mm 112.0mm 131.0mm 148.0mm 45.0mm 55.0mm 80.0mm 130.0mm 170.0mm Blade Width 11.0mm 10.0mm 13.5mm 14.5mm 14.5mm 15.5mm 10.0mm 10.0mm 10.0mm 13.0mm 13.0mm Size Adult Paediatric Stubby Batteries Required 2xC 2 x AA 2 x AA Smoothline Laryngoscope Blades, Green System Fitting, Matt Finish Part Number H9020 H9021 H9022 H9023 H9024 H9025 H9029 H9030 H9031 H9032 H9033 HGSKESS3 HGSKESS4 HGSLEFTHMAC3 Style Macintosh Macintosh Macintosh Macintosh Macintosh Macintosh Miller Miller Miller Miller Miller Kessel Kessel Left-Handed Macintosh HGSLEFTHMAC4 Left-Handed Macintosh HGSMAGILL0 Magill HGSMAGILL1 Magill HGSMAGILL2 Magill HGSMAGILL3 Magill HGSPOLIOMAC3 Polio HGSPOLIOMAC4 Polio HGSRSHAW0 Robertshaw HGSRSHAW1 Robertshaw HGSSEWARD1 Seward HGSSEWARD2 Seward HGSWISC0 Wisconsin HGSWISC1 Wisconsin HGSWISC2 Wisconsin Size 0 1 2 3 4 5 00 0 1 2 3 3 4 3 Blade Length 58.0mm 72.0mm 88.0mm 112.0mm 131.0mm 148.0mm 45.0mm 55.0mm 80.0mm 130.0mm 170.0mm 112.0mm 131.0mm 111.5mm Blade Width 11.0mm 10.0mm 13.5mm 14.5mm 14.5mm 15.5mm 10.0mm 10.0mm 10.0mm 13.0mm 13.0mm 14.5mm 14.5mm 14.5mm 4 130.0mm 15.0mm 0 1 2 3 3 4 0 1 1 2 0 1 2 74.0mm 83.0mm 101.0mm 153.0mm 115.0mm 135.0mm 70.0mm 90.0mm 83.0mm 108.0mm 54.0mm 80.0mm 88.0mm 10.5mm 12.0mm 12.0mm 13.5mm 15.0mm 15.0mm 9.5mm 10.5mm 9.5mm 13.5mm 10.7mm 10.7mm 12.5mm Manufactured for: PROACT Medical Ltd 9-13 Oakley Hay Lodge, Great Folds Road, Oakley Hay Business Park, Corby, Northants, NN18 9AS, UK Tel: +44 (0)1536 461981 E-mail: sales@proactmedical.co.uk PROACT Medical SAS Parc d’Activitiés des Béthunes, 8 Avenue du Fief Lot No 9, BP 20424 Saint Ouen l’Aumône, 95005 Cergy Pointoise Cedex, France Tel: +33 (0) 1.34.42.95.32 E-mail: ventes@proactmedical.fr IFU 203 - v1 2/2