Silicone Laryngeal Mask Airway singel use & reusable

Silicone Laryngeal Mask Airway singel use & reusable HIGH QUALITY, FINELY DESIGN QUALITY CONTINUOUS DEVELOPMENT

 NEWS!!!   Welcome to visit our booth, Hall 6, J48, MEDICA 2012

  

Silicone Laryngeal Mask Airway Single use & Reusable

I. INTENDED USE

The Laryngeal mask (LM) is a supraglottic airway management device.

II. HIGH QUALITY, FINELY DESIGN

1. Fit your needs

    FORMED LM includes 5 types and various accessories, all are latex-free.

    ·4 types were pure silicone (Disposable & Reusable, Standard & Reinforced).

    ·1 type was PVC.

    ·All patients should have the optimal catheter for their personal situation. 

    ·We have eight different sizes from neonate to adult.

2. Made of pure Silicone

    The materials are meet the test requirements of     ·USP Class VI     ·ISO 10993: Cytotoxicity, Sensitization and Irritation

3. Designs for guarantee reusable performances:

    ·Our reusable LM meet the requirements of re-sterilization and aging test :        .1  No change or damage after 40 times steam sterilization test.         .2  Good performances after accelerated aging test (ASTM 1980).    ·Every product with unique tracking number and record card, to avoid

        confusion and ensures the correct record after use.

4. Reinforced tube minimized crushing or kinking

    ·Kink-free wire-reinforced tube eliminates the risk of airway tube occlusion.

5. PRODUCTION QUALITY CONTROL

    According to quality management system EN ISO 13485, we can guarantee the traceability of

    each production process. Including purchasing, extrusion, molding, product assembly, packaging,

    sterilization, inspection, in-house and delivery, until final clinical use.

III. FEATURES AND BENEFITS

    - Made of pure medical grade silicone, have good biocompatibility, non-toxic.    - Exclusive soft seal cuff can be insert comfortable, minimizing potential trauma and increasing sealing.    - Kink-free wire-reinforced tube eliminates the risk of airway tube occlusion.    - Reusable types must be cleaning and disinfection or sterilization before use, use only 40 times.    - Every product with unique serial number and record card, to avoid confusion and

      ensures the correct record after use.    - Have different sizes, suitable for neonate, infant, children and adult.  

IV. Specification

Silicone Laryngeal Mask Airway singel use & reusable.

Size	Disposable  Silicone LM	Disposable  Reinforced LM	Reusable  Silicone LM	Reusable  Reinforced LM	Patient  Weight	Cuff  Volume
1.0#	PA0101 10	PA0102 10	PA0103 10	PA0104 10	< 5kg	<4ml
1.5#	PA0101 15	PA0102 15	PA0103 15	PA0104 15	5-10kg	<7ml
2.0#	PA0101 20	PA0102 20	PA0103 20	PA0104 20	10-20kg	<10ml
2.5#	PA0101 25	PA0102 25	PA0103 25	PA0104 25	20-30kg	<14ml
3.0#	PA0101 30	PA0102 30	PA0103 30	PA0104 30	30-50kg	<20ml
4.0#	PA0101 40	PA0102 40	PA0103 40	PA0104 40	50-70kg	<30ml
5.0#	PA0101 50	PA0102 50	PA0103 50	PA0104 50	70-100kg	<40ml
6.0#	PA0101 60	PA0102 60	PA0103 60	PA0104 60	> 100kg	<50ml

  For Single use only

    It is recommended that the Laryngeal Mask be used maximum of 40 times.

                                            

STERILIZED BY EO      LATEX FREE       DEHP FREE

V. Instructions for use (for clinical use only) 

This product should be used by a physician or medical professional as follows:

1   The cuff  inflation must be checked before use. DO NOT USE if cuff fails to inflate.2   Place on a flat surface then deflate the mask cuff with a syringe.3   The back plate of the mask should be lubricated with an appropriate lubricant.4   Make sure that the patient's head is in the 'sniffing the morning air' position.5   The laryngeal mask should be held as if holding a pen, with the open end of the

     mask pointing downwards towards the tongue.6   Using an index finger for assistance, insert the laryngeal mask along the hard and

     soft palate (Fig A), guiding the mask all the way through the natural bend of the

     airway until feeling resistance (Fig B).7   Create a seal by inflating the mask cuff (Fig C).8   Airway patency should be confirmed by auscultation.9   If required insert a bite block and secure the mask airway.10 Connect mask to breathing circuit.

VI. Re-sterilization Methods:

1   Wash the Laryngeal Mask with soap, distilled water or NaHCO3 (saleratus).

     Forbid using formaldehyde, phenol, aseptic with iodine or lubricant with silicone.2   Brush gently the airway tube.3   Wash the Laryngeal Mask cleanly with distilled water. 4   Make sure Laryngeal Mask is dry.5   Deflate all the air from Laryngeal Mask before steam autoclave.6   Steam autoclave 3 minutes at 134 C (+4 C/-0 C).

 CAUTION

1  Sterilized by Ethylene Oxide (EO).

2  Recommended be used maximum of 40 times.

3  Do not exceed the recommended maximum inflation volumes.

4  Do not use if the package or product has been damaged or contaminated.

5  Do not store at extreme temperatures and humidity, avoid direct sunlight.

 ODM  

Special design for your requirements: 

- High temperature resistant raw materials.

- Tube marking by your requirements.

- Unique tracking number and record card.

- High quality TYVEK package.

- Any other special design only for you. 

VII. FIGURES

  

 - Unique tracking number and record card

   

 - Thin wall pilot balloon provides precise indication of inflation

 - Silicone soft cuff ensuire best possible seal

   ABOUT US

FORMED Focus on research & design, manufacture, quality management, global sales, technical support and OEM contract. We have three main business areas: Anaesthesia & Respiratory, Gastroenterology and Urology. The products are now sold worldwide. With sales high quality products, we also provide professional technical solutions (ODM Sevices), experiences in particular of silicone products, TPU tubes and self-use intermittent products.   

FOR MEDICAL TECHNOLOGY, FOR LIFE CARE 

is our first philosophy. According to quality management system EN ISO 13485, we can guarantee the traceability of each production process. Including purchasing, extrusion, molding, product assembly,  packaging, sterilization, inspection, in-house and delivery, until final clinical use. 

FACTORY & MACHINESWe have class 100,000 Clean Room, Laboratory, and range of manufacturing machines: Silicone mixing, Silicone Extrusion,  LIM (Liquid silicone Injection Molding, Plastic Extrusion, Plastic injection molding, Plate Vulcanizing, Pad printing, Auto package sealing, etc. 

Silicone Laryngeal Mask Airway singel use & reusable