ISO 8600-2:2015 pdf download – Endoscopes – Medical endoscopes andendotherapy devices — Part 2: Particular requirements for rigidbroncho scopes
ISO 8600-2:2015 pdf download – Endoscopes – Medical endoscopes andendotherapy devices — Part 2: Particular requirements for rigidbroncho scopes.
4.3 Rigid ventilation bronchoscopes
4.3.1 A rigid ventilation bronchoscope shall be provided with an integral ventilation connector and an end-cap at its proximal end. Provision shall be made for insertion of endoscopes and endoscopic accessories through the end-cap. The end-cap shall not accidentally detach at an airway pressure of less than 4,0 kPa (40 cmH2O).
An end-cap may incorporate a transparent window and/or may permit the insertion of an endoscope or endoscopic accessory through the opening or an airtight gasket. Removal or opening of the end-cap for accessory Insertion may be achieved by the detachment, rotation or sliding of the end-cap.
4.3.2 A rigid ventilation bronchoscope shall be provided, in a side-arm, either with an integral ventilation connector or shall be provided with a detachable adapter which shall meet the requirements for 15 mm male conical connectors specified in ISO 5356-1 (see Figure 1). This shall not be a connector in which the internal lumen has been reduced. The ventilation connector, when fitted to the rigid ventilation bronchoscope. shall permit to-and-fm ventilation of the patient.
Adding a smaller connector to a 15 mm adapter creates a low dead-space connector. Users should be aware of the danger of using two connected low dead-space connectors, which may cause excessive flow resistance.
A ventilation connector may be located at either side of the rigid bronchoscope (see Figure 1) and may swivel around the shaft of the rigid bronchoscope.
4.4 Rigid jet-ventilation bronchoscopes
4.4.1 Rigid jet-ventilation bronchoscopes shall be provided with a jet-injector intended for jet ventilation.
let ventilation through a rigid bronchoscope is usually possible without a separate jet-injector port. FIgure 2 gives examples of different bronchoscopes where jet Injection is possible.
4.4.2 When tested in accordance with 5,3, a jet-injector supplied with a bronchoscope shall withstand a minimum force of 20 N without becoming detached.
4.4.3 When tested in accordance with SA. the container pressure generated by a rigid jet-ventilation bronchoscope with any jet-injector provided by the manufacturer shall not exceed 6.0 kPa (60 cmH2O).
lithe bronchoscopist uses jet-injectors other than those provided by the manufacturer, he/she is responsible for its function and performance.
The ventilation pressure developed byany jet-injectordepends on thecharactenstics ofthe bronchoscope with which it is used or tested. Users should be aware that ventilation pressure can be greatly increased by insertion of any obstruction, e.g. an aspirator or forceps, into the lumen of the rigid bronchoscope.
4.5 Side apertures
4.5.1 Side apertures, If provided, shall be located on the rigid bronchoscope no closer than S % of the working length from the distal tip.
4.5.2 The minimum total area of the side apertures shall not be less than the cross-sectional area of the minimum instrument channel width.
45.3 The side apertures shall have a smooth rounded finish.
22.214.171.124 Attach the jet-injector to the rigid jet-ventilation bronchoscope as recommended by tue manufacturer.
126.96.36.199 Mount the rigid jet-ventilation bronchoscope so that the jet-injector channel is in the vertical position (see Figure 8). Hang masses vertically to pull in the line olthe axis of the jet-inpectorchannel until a force of 20 N is reached or the jet-injector separates from the bronchoscope.
5.3.4 Expression of results
Note whether or not separation of jet-injector from the bronchoscope has occurred at the maximum test force (20 N).
5.4 Test method for container pressure with an open-ended jet-injector bronchoscope
To determine the maximum air driving pressure to the jet-injector which provides a container pressure not exceeding 6,0 kPa (60 cmHz0). The driving pressure is the static pressure downstream of the adjustable regulator.
5.4.2 Apparatus See Eigure9.
188.8.131.52 Rigid jet-ventilation bronchoscope.
184.108.40.206 Adjustable pressure regulator. (with 400 kPa supply).
220.127.116.11 41 test container, which incorporates a test pressure gauge with a range of 0 kPa to 10.0 kPa
(0 cmH2O to 100 cmH2O) and an accuracy of ±0,2 kPa (±2,0 cmHzO) and a sealed aperture that permits
Insertion of the patient end of the bronchoscope under test.
18.104.22.168 Clamp, to hold the bronchoscope in a test position. If a prism is provided (see Figktrej, key 5), ensure that It Is fully advanced Into the lumen of the rigid bronchoscope.
22.214.171.124 Carry out the test at (20 ± 3) °C.
126.96.36.199 Set the adjustable pressure regulator at 100 kPa. switch on the air line for 10 s and observe the container pressure. If the container pressure is greater than 6,0 kPa (60 cmH2O), decrease the air driving pressure in Increments of 10 kPa until the container pressure is less than 6.0 kPa (60 cr111120). If the container pressure is less than 6.0 kPa (60 cmH2O), increase the air driving pressure In increments of 10 kPa until the container pressure exceeds 6,0 kPa (60 cniH2O), or an air driving pressure of 400 kPa is reached, whichever comes first.