Fiber optic laryngoscope handles Directions for use
Contents
1. 2014 Welch Allyn Inc MM 721462 Ver C Fiber optic laryngoscope handles Directions for use Intended use The fiber optic laryngoscope handle is an accessory used with compatible rigid fiber optic laryngoscope blades which are used to examine and visualize apatient s airway and aid placement of a tracheal tube About this document This directions for use apply to Welch Allyn reusable fiber optic laryngoscope handles 60813 60814 60815 Welch Allyn reusable fiber optic laryngoscope handles may be used with Welch Allyn fiber optic laryngoscope blades MacIntosh REF 6906X English Macintosh REF 6921X and Miller REF 6806X Warnings and cautions gt PEP PpP PE FE WARNING Reusable fiber optic laryngoscope handles must be reprocessed after each use WARNING The reprocessing procedure and the equipment and materials described must be followed and conducted by persons trained and familiar with medical device reprocessing WARNING Consult cleaning and disinfecting agent manufacturer instructions for their proper preparation and use WARNING Repeated reprocessing may degrade elements of the handle Follow inspection procedures to assure damage has not occurred to the handle WARNING High level disinfection and or sterilization are not achieved by these methods WARNING Lamps if left illuminated could generate sufficient heat to cause burns WARNING Discard any component that shows evidence of damage or det2. components are compatible with the disinfection solution and autoclave methods identified which are provided for facilities who wish to perform either method after cleaning and intermediate level disinfection Cleaning and intermediate level disinfection instructions Point of use 1 Separate blade assembly from handle and place handle into suitable containment for subsequent reprocessing per figure 1 Do not place handle with sharp devices 2 Prevent the handle from drying i e wrap cover in moist germicidal wipe Preparation for 1 Select an appropriate quaternary ammonium decontamination isopropanol based germicidal cleaner labeled suitable for use on healthcare equipment and capable intermediate level disinfection Reference EPA registered disinfectants http www epa gov oppad001 chemregindex htm Outside of the U S please consult applicable regulatory body for equivalent quaternary ammonium isopropanol germicidal cleaner 2 Remove batteries and lamp cartridge per figure 2 Figure 1 Directions for use Cleaning and intermediate level disinfection Drying Maintenance Inspection and Testing Storage Welch Allyn fiber optic laryngoscope handles Follow the germicidal wipe manufacturer s instructions to clean all exposed surfaces of the main handle end cap and lamp cartridge If necessary brush with a dry soft bristled brush and re wipe to loosen remove excessive visible soil After all visible
3. soil is removed re wipe to wet all surfaces and allow adequate contact time for disinfection as directed by the germicidal wipe manufacturer CAUTION Only use quaternary ammonium isopropanol based germicidal wipes Allow components to air dry Inspect each component area per figure 3 for damage or deterioration WARNING Discard any component that shows evidence of damage or deterioration Contact Welch Allyn for component replacement Reassemble handle per figure 4 with new or batteries in known good condition Attach handle to aclean and disinfected test blade assembly in known working condition Verify that e Blade assembly engages and locks onto handle e Blade assembly deploys into its locked position on handle AND lamp illuminates e Light output is satisfactory If the lamp fails to light or output is low check or replace the lamp and or batteries Store handle per facility practice to allow device to remain clean dry and ready for service End of reprocessing instructions for intermediate level disinfection Handle REE number 2 Main handle 3 Lamp cartridge assembly 4 Batteries 5 Bottom cap Figure 4 3 4 Directions for use Welch Allyn fiber optic laryngoscope handles Cold solution disinfection instructions NOTE The main handle and bottom cap are compatible with this cold solution disinfection method which is provided for facilities who wish to solution disinfect after
4. cleaning and intermediate level disinfection Disassembly Preparation for decontamination Cold solution disinfection Drying Maintenance Inspection and Testing Storage 1 Disassemble the handle and remove batteries and lamp cartridge per figures 3 2 Set batteries and lamp cartridge aside 1 Select a 14 day 2 4 2 6 glutaraldehyde disinfectant 2 Prepare disinfection solution per manufacturer instructions 1 Immerse main handle and bottom cap only in disinfection solution for atime duration identified by the disinfection solution manufacturer 2 Thoroughly rinse all components in potable water softened water or per disinfection solution manufacturer instructions to remove disinfecting solution Dry all components with a clean cloth or allow to air dry 1 Inspect each component area per figure 2 for damage or deterioration WARNING Discard any component that shows evidence of damage or deterioration Contact Welch Allyn for component replacement 2 Reassemble handle per figure 4 with new or batteries in known good condition 3 Attach handle to aclean and disinfected test blade assembly in known working condition Verify that e Blade assembly engages and locks onto handle e Blade assembly deploys into its locked position on handle AND lamp illuminates e Light output is satisfactory If the lamp fails to light or output is low check or replace the lamp or batteries St
5. e to side until the shroud cap exits opening on top Re insert batteries and apply slight pressure to set the cartridge in place Replace and tighten bottom cap Reprocess repaired assembly as appropriate per these instructions Figure 4 1 Shroud cap 2 Lamp Figure 7 Cheo Directions for use Welch Allyn standard laryngoscope handles Replace the batteries 1 Unscrew bottom cap of handle per figure 3 and remove batteries 2 Alkaline batteries are supplied with your handle for maximum performance and are recommended as replacements however carbon zinc batteries may also be used Medium handle REF 60813 uses two C size Penlight handle REF 60814 uses two AA size Stubby handle REF 60815 uses two AA size Insert batteries and reinstall bottom cap per figure 3 Verify lamp and blade engagement operation using a known working test blade Reprocess repaired assembly as appropriate per these instructions oh Specifications Electrical For information about electromagnetic compatibility EMC see Welch Allyn website http www welchallyn com Operating Storage Transport 104 F 120 F Xt C p C 32 F 4 F 0C 20 C Approvals Conforms to ASTM F 965 and ISO 7376 1 IEC EN 60601 1 IEC EN 60601 1 2 The CE mark on this product indicates that it has been tested to and conforms C with the provisions noted within the 93 42 EEC Medical Device Directive LO Complies with EMC Framew
6. erioration WARNING Do not modify this equipment Any modification of this equipment may lead to patient injury Any modification of this equipment voids the product warranty WARNING Personnel shall follow their facility policies and procedures and wear appropriate personal protective equipment when handling potentially contaminated equipment WARNING Laryngoscope equipment is not suitable for use in intense magnetic fields CAUTION Only use lamp specified Failure to follow these instructions may cause damage or poor performance of the handle CAUTION If the device will be unused for several months or longer remove the batteries prior to storing the device 2 Directions for use Welch Allyn fiber optic laryngoscope handles Reprocessing instructions These reprocessing instructions refer to procedures for cleaning and intermediate level disinfection Fiber optic laryngoscope handles must be reprocessed prior to first use and between each use using the following method as outlined in this document e Cleaning and intermediate level disinfection Welch Allyn has validated the above instruction as being capable of preparing these laryngoscope handles for re use The user must ensure that the reprocessing as actually performed by the user s personnel with the user s equipment and materials achieves the desired result This may require validation and routine monitoring of the user s actual process NOTE The main handle and bottom cap
7. igure 4 with new or batteries in known good condition 3 Attach handle to a clean and disinfected test blade assembly in known working condition Verify that e Blade assembly engages and locks onto handle e Blade assembly deploys into its locked position on handle AND lamp illuminates e Light output is satisfactory If the lamp fails to light or output is low check or replace the lamp and or batteries Storage Store handle per facility practice to allow device to remain clean dry and ready for service 6 Directions for use Welch Allyn standard laryngoscope handles Maintenance instructions Replace the lamp s oS O p Figure 3 Figure 5 NI Figure 6 a 3 Shroud WARNING Lamps if left illuminated could generate sufficient heat to cause burns CAUTION Use only Welch Allyn replacement lamps REF 06000 to ensure proper illumination alignment Unscrew bottom cap of handle counterclockwise and remove batteries per figure 3 Remove lamp cartridge assembly from main handle by applying finger pressure in the direction shown by the arrow per figure 4 Remove shroud cap from shroud by rotating shroud cap counterclockwise per figures 5 and 6 Rotate lamp counterclockwise to remove per figure 6 Replace lamp and rotate shroud cap clockwise to tighten per figure 7 To replace lamp cartridge assembly in the main handle invert handle then gently slide the cartridge down the inside of handle tipping it sid
8. ore handle per facility practice to allow device to remain clean dry and ready for service Directions for use Welch Allyn fiber optic laryngoscope handles 5 Autoclave instructions NOTE The main handle and bottom cap are compatible with these autoclave methods which are provided for facilities who wish to autoclave after cleaning and intermediate level disinfection 1 Disassemble the handle and remove batteries and lamp cartridge per figures 3 Disassembly 2 Set batteries and lamp cartridge aside After battery and lamp cartridge removal select ONE of the following autoclave methods below for the main handle and bottom cap Gravity autoclave Follow equipment manufacturer and facility procedures in the set up and operation of autoclave equipment Gravity autoclave settings are as follows e Temperature 132 C 270 F e Exposure time 3 minutes unwrapped e Minimum dry time 1 minute Pre vacuum autoclave Follow equipment manufacturer and facility procedures in the set up and operation of autoclave equipment Pre vacuum autoclave settings are as follows e Temperature 132 C 270 F e Exposure time 3 minutes unwrapped e Minimum dry time 1 minute Maintenance 1 Inspect each component area per figure 2 for damage or Inspection and Testing deterioration WARNING Discard any component that shows evidence of damage or deterioration Contact Welch Allyn for component replacement 2 Reassemble per f
9. ork of Australia Warranty One year Service Information For Technical Support or to obtain information about any Welch Allyn product contact Welch Allyn Technical Support www welchallyn com support f Welch Allyn Inc Authorized European Representative Address 4341 State Street Road Requl Atairs R tati Skaneateles Falls NY 13153 0220 USA Walch Alb pre m alive eA ent datet Navan Business Park Dublin Road Navan County Meath Republic of Ireland
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