| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 5<\/td>\n | Anaesthetic and respiratory equipment\ufffd\u2014 Tracheostomy tubes\ufffd\u2014 <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Anaesthetic and respiratory equipment\ufffd\u2014 Tracheostomy tubes\ufffd\u2014 1\ufffd\ufffd\ufffd Scope 2\ufffd\ufffd\ufffd Normative references 3\ufffd\ufffd\ufffd Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4\ufffd\ufffd\ufffd Size designation and dimensions 4.1\ufffd\ufffd\ufffd Inside diameter 4.1.1\ufffd\ufffd\ufffd The size of the tracheostomy tube (outer tube) shall be designated by the nominal inside… <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.1.2\ufffd\ufffd\ufffd For tracheostomy tubes with the conical connector permanently attached to the inner tube… 4.2\ufffd\ufffd\ufffd Outside diameter 4.2.1\ufffd\ufffd\ufffd The outside diameter (OD) of sections 4.2.2\ufffd\ufffd\ufffd The actual outside diameter of section 4.2.3\ufffd\ufffd\ufffd The actual outside diameter of section 4.3\ufffd\ufffd\ufffd Length 4.3.1\ufffd\ufffd\ufffd The nominal length (dimensions 4.3.2\ufffd\ufffd\ufffd The actual nominal length (dimensions 4.3.3\ufffd\ufffd\ufffd For tubes with an adjustable neck-plate, the range of measurements for nominal length (s… 4.3.4\ufffd\ufffd\ufffd Dimensions 4.4\ufffd\ufffd\ufffd Angle <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5\ufffd\ufffd\ufffd Materials 6\ufffd\ufffd\ufffd Design and finish 6.1\ufffd\ufffd\ufffd Machine end 6.1.1\ufffd\ufffd\ufffd Tracheostomy tubes or their inner cannulae shall have at the machine end a permanently a… 6.1.2\ufffd\ufffd\ufffd The inside diameter of the conical connector at the machine end shall be not less than t… 6.1.3\ufffd\ufffd\ufffd Any transition in inside diameter shall be tapered to give an adequate lead-in for passa… 6.1.4\ufffd\ufffd\ufffd When tested in accordance with annex\ufffd 6.2\ufffd\ufffd\ufffd Neck-plate 6.2.1\ufffd\ufffd\ufffd Tracheostomy tubes shall have a neck-plate which shall be adjustable or permanently atta… 6.2.2\ufffd\ufffd\ufffd The neck-plate shall be provided with holes or other means to permit attachment to the p… 6.2.3\ufffd\ufffd\ufffd If a tracheostomy tube has an adjustable neck-plate, it shall be securable to the tube. … 6.2.4\ufffd\ufffd\ufffd When tested in accordance with annex\ufffd 6.3\ufffd\ufffd\ufffd Inner tube 6.3.1\ufffd\ufffd\ufffd The inner tube, if provided with the outer tube, shall extend to within 6.3.2\ufffd\ufffd\ufffd The machine end of the inner tube shall either comply with 6.4\ufffd\ufffd\ufffd Cuff 6.4.1\ufffd\ufffd\ufffd A cuff, if provided, shall be permanently attached to the tube. 6.4.2\ufffd\ufffd\ufffd Cuffs of tracheostomy tubes shall satisfy the requirements of 6.4.3\ufffd\ufffd\ufffd The cuff resting diameter shall be within <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6.5\ufffd\ufffd\ufffd Inflating tubes for cuffs 6.5.1\ufffd\ufffd\ufffd Inflating tube 6.5.2\ufffd\ufffd\ufffd Pilot balloon 6.5.2.1\ufffd\ufffd\ufffd The inflating tube shall have a pilot balloon and\/or other means to indicate inflation… 6.5.2.2\ufffd\ufffd\ufffd The intentional evacuation of the cuff shall not be prevented by the inflating tube, i… 6.5.3\ufffd\ufffd\ufffd Free end of inflating tubes for cuffs 6.6\ufffd\ufffd\ufffd Patient end 6.7\ufffd\ufffd\ufffd Introducer 7\ufffd\ufffd\ufffd Requirements for tracheostomy tubes supplied sterile 7.1\ufffd\ufffd\ufffd Sterility assurance <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 7.2\ufffd\ufffd\ufffd Packaging for tracheostomy tubes supplied sterile 7.2.1\ufffd\ufffd\ufffd The following information shall be apparent on visual examination of the intact unit con… 7.2.2\ufffd\ufffd\ufffd Each tracheostomy tube supplied and marked as \u201cSTERILE\u201d shall be contained in an individ… 8\ufffd\ufffd\ufffd Marking and labelling 8.1\ufffd\ufffd\ufffd General 8.2\ufffd\ufffd\ufffd Marking of the neck-plate 8.2.1\ufffd\ufffd\ufffd The following information shall be marked on the neck-plate and shall be visible from th… 8.2.2\ufffd\ufffd\ufffd Cuffed tubes intended for reuse shall be marked with the resting diameter of the cuff de… 8.3\ufffd\ufffd\ufffd Labelling of unit packs 8.3.1\ufffd\ufffd\ufffd Use of symbols 8.3.2\ufffd\ufffd\ufffd Labelling of tracheostomy tube unit packs <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 8.3.3\ufffd\ufffd\ufffd Labelling of inner tube unit packs <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Test method for the security of attachment of connector and neck-plate to tracheostomy tube A.1\ufffd\ufffd\ufffd Principle A.2\ufffd\ufffd\ufffd Apparatus A.2.1\ufffd\ufffd\ufffd Means of conditioning A.2.2\ufffd\ufffd\ufffd Means of securing A.2.3\ufffd\ufffd\ufffd Means of securing A.3\ufffd\ufffd\ufffd Procedure A.3.1\ufffd\ufffd\ufffd Condition the tracheostomy tube at A.3.2\ufffd\ufffd\ufffd Remove the tracheostomy tube from the conditioning chamber and secure the connector and … A.3.3\ufffd\ufffd\ufffd Within A.3.4\ufffd\ufffd\ufffd Having already removed the tracheostomy tube from the conditioning chamber, secure the n… A.3.5\ufffd\ufffd\ufffd Within A.4\ufffd\ufffd\ufffd Expression of results <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Test method for determining the resting diameter of the cuff B.1\ufffd\ufffd\ufffd Principle B.2\ufffd\ufffd\ufffd Apparatus B.3\ufffd\ufffd\ufffd Procedure B.3.1\ufffd\ufffd\ufffd Inflate the cuff with sufficient air to create an internal overpressure of B.3.2\ufffd\ufffd\ufffd Locate the plane of maximum cuff diameters perpendicular to the axis of the tube. Measur… B.4\ufffd\ufffd\ufffd Expression of results <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Guidance on materials and design C.1\ufffd\ufffd\ufffd Materials C.1.1\ufffd\ufffd\ufffd The materials used for the manufacture of the tubes should have sufficient rigidity to a… C.1.2\ufffd\ufffd\ufffd Unless intended and marked for single use, tracheostomy tubes should be reasonably resis… C.1.3\ufffd\ufffd\ufffd Tracheostomy tubes under normal conditions of use should be reasonably resistant to dete… C.1.4\ufffd\ufffd\ufffd Tracheostomy tubes should be readily detectable by X-ray either by the nature of the mat… C.1.5\ufffd\ufffd\ufffd When not in use the tracheostomy tube should maintain its intended shape when stored in … C.2\ufffd\ufffd\ufffd Design C.2.1\ufffd\ufffd\ufffd Tracheostomy tubes, including the neck-plate, should have smooth external and internal s… C.2.2\ufffd\ufffd\ufffd The patient end of the tracheostomy tube should be free from sharp edges. C.2.3\ufffd\ufffd\ufffd The neck-plate should be rounded at the edges, and its shape should adapt to the contour… C.2.4\ufffd\ufffd\ufffd For tracheostomy tubes with an adjustable neck-plate, use of the mechanism for securing … C.2.5\ufffd\ufffd\ufffd A retaining or latching device may be incorporated in the design to provide added securi… <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Anaesthetic and respiratory equipment. Tracheostomy tubes – Tubes and connectors for use in adults<\/b><\/p>\n |