Standard Operating Prcedure Otscpes and Ophthalmscpes SOP Number: SOP-OO-01.1 Categry: Lab Prcess Supersedes: SOP-OO-01 Effective Date: December 1, 2017 Pages 7 Subject: Otscpes and Ophthalmscpes Prepared By: Lisa McAvy 28/Nv/17 dd/mmm/yy Apprved By: Vernica Harris-McAllister 30/Nv/17 dd/mmm/yy 1.0 POLICY This standard perating prcedure (SOP) describes the crrect prcedures when using the Welch Allyn MacrView Otscpe with thrat illuminatr and caxial Ophthalmscpe fr clinical research, including clinical trials, in the W.J. Hendersn Centre fr Patient-Oriented Research (WJHCPOR). The tscpes and phthalmscpes are intended t be used by qualified and trained users f the WJHCPOR fr eye, ear, and thrat examinatin f research participants. Only trained medical prfessinals can prvide diagnsis f any clinical findings presented by research participants upn examinatin. 2.0 PURPOSE T ensure all users f the WJHCPOR use crrect prcedures when using the tscpes and phthalmscpes fr eye, ear and thrat examinatin f research participants. 3.0 RESPONSIBILITY Users are respnsible fr: Attending rientatin and training n the prper use f the tscpes and phthalmscpes. Fllwing the prcedures listed in this SOP. NOTE: If at any time users are unsure hw t perate the tscpes and phthalmscpes safely, please refer t the instructinal manuals and/r ask the designated KGHRI staff member fr assistance. Reprting any damage t the tscpes and phthalmscpes t the designated KGHRI staff member immediately s equipment repairs can be made. Versin 1.1 (February 1, 2018) - 1 SOP-OO-01.1
Cleaning the tscpes and phthalmscpes after each use and between research participants. KGHRI is respnsible fr: Ensuring all tscpes and phthalmscpes are in gd repair and labelled with apprpriate cntact infrmatin fr maintenance and repair. Training new users in safe usage and maintenance f the tscpes and phthalmscpes, dcumenting the training f all users, and supervising use when necessary. Ensuring instructinal manuals (see Appendix A and Appendix B) are readily available t all users, if required. Ensuring that all the regular and peridic maintenance required fr the tscpes and phthalmscpes is carried ut and recrded in the Maintenance Lg. The designated KGHRI staff member will cntact Kingstn Health Sciences Centre s (KHSC) Clinical Engineering Department when regular maintenance inspectin and repairs are required. Ensuring the recrds f repair are kept and available fr inspectin. Prviding apprpriate cleaning supplies t users f the WJHCPOR. Charging the tscpes and phthalmscpes. 4.0 PROCEDURE Using the Otscpe fr Ear Examinatins The tscpe is intended t allw users f the WJHCPOR the ability t perfrm an examinatin f the external ear, ear canal and tympanic membrane under magnificatin. Using the tscpe head: Align the cututs in the tscpe head base with the 3.5-vlt pwer surce lug. Push dwn slightly and turn 90 clckwise. T remve, reverse the prcedure. See Figure 1 belw. Align ne f the Welch Allyn dispsable/single-use specula tips (adult tip 4.25 mm r paediatric tip 2.75 mm) nt the tscpe using a dispsable glve. Twist the specula clckwise until it clicks int the lcked psitin. See Figure 1 belw. T remve the specula tip, turn the TipGrip r twist the specula cunterclckwise. The specula tips are dispsable/single-use and shuld be tssed int the regular waste bin/cntainer after use. A new specula tip shuld be used fr each research participant. Versin 1.1 (February 1, 2018) - 2 SOP-OO-01.1
Figure 1: Using the Otscpe T turn the tscpe n, push the green buttn n the 3.5-vlt pwer surce lug and rtate the wheel clckwise. The tscpe is n when the light is n. T turn the tscpe ff, rtate the wheel cunterclckwise until yu hear the green buttn click back int place. The light will be ff when the tscpe is ff. T fcus align the green line t the green dt and rtate either the inner r uter wheel t fine tune the image f the eye. See Figure 2 belw. Figure 2: Using the Fcus n the Otscpe Perfrm the ear examinatin. Versin 1.1 (February 1, 2018) - 3 SOP-OO-01.1
Using the Ophthalmscpe fr Eye Examinatins The phthalmscpe is intended t allw users f the WJHCPOR the ability t perfrm an examinatin f the fundus and ther cular structures (crnea, iris, pupil, lens) f the eye under magnificatin. Using the phthalmscpe head: Align the cututs in the phthalmscpe head base with the 3.5-vlt pwer surce lug. See Figure 3 belw. Push dwn slightly and turn 90 clckwise. T remve, reverse the prcedure. Rubber brw rest Frnt surface mirrr Crss linear plarizing/red-free filter switch Lens selectin disc Aperture selectin disc Illuminated lens indicatr Ophthalmscpe head base Figure 3: Using the Ophthalmscpe T turn the phthalmscpe n, push the green buttn n the 3.5-vlt pwer surce lug and rtate the wheel clckwise. The phthalmscpe is n when the light is n. T turn the phthalmscpe ff, rtate the wheel cunterclckwise until yu hear the green buttn click back int place. The light will be ff when the phthalmscpe is ff. Chse the apprpriate aperture. There is a wide range f practical apertures t select frm: micr spt, small spt, large spt, fixatin, slit, and cbalt blue filter. A red-free filter (green dt) is als available and can be used in cnjunctin with any apertures. When the switch is psitined t the right (circle with crsshairs inside) the crssed linear plarizing filter will be in place and can be used in cnjunctin with any apertures. See Figure 3 abve. Perfrm the eye examinatin. Versin 1.1 (February 1, 2018) - 4 SOP-OO-01.1
Using the Otscpe fr Thrat Examinatins The base f the tscpe can be transfrmed int a thrat illuminatr. Using the thrat illuminatr head: Grasp the tscpe sectin with yur left hand. Grasp the thrat illuminatr cllar (under the silver ring). Hld the thrat illuminatr cllar statinary and twist the tscpe sectin cunterclckwise until the tscpe head is remved. See Figure 4 belw. In rder fr the thrat illuminatr t wrk it must be attached t the 3.5-vlt pwer surce lug. T turn the thrat illuminatr n, push the green buttn n the 3.5-vlt pwer surce lug and rtate the wheel clckwise. The thrat illuminatr is n when the light is n. T turn the thrat illuminatr ff, rtate the wheel cunterclckwise until yu hear the green buttn click back int place. The light will be ff when the thrat illuminatr is ff. T replace the tscpe sectin, align the tscpe sectin with the tp f the thrat illuminatr and turn clckwise. Perfrm the thrat examinatin. Figure 4: Using the Thrat Illuminatr Cleaning the Otscpes and Ophthalmscpes After each research participant use, users MUST wipe dwn tscpes and phthalmscpes with a dry clth. DO NOT apply alchl, chemicals, cleaning prducts r water as it will damage the tscpes and phthalmscpes. Ensure the tscpes and phthalmscpes are ff befre cleaning. Versin 1.1 (February 1, 2018) - 5 SOP-OO-01.1
Charging the Otscpes and Ophthalmscpes Attach the 3.5-vlt pwer surce lug t the AC charging mdule. See Figure 5 belw. Push the black buttn n the wall charger unit and pull the case f the AC charging mdule twards the 3.5-vlt pwer surce lug. This will retract the AC prngs. See Figure 6. Plug the unit int an electrical wall pwer surce t allw the unit t charge. Charge fr 12 cntinuus hurs. Once fully charged the 3.5-vlt pwer surce lug will last fr tw (2) cntinuus hurs befre it needs t be charged again. 3.5-vlt pwer surce lug AC charging mdule Otscpe head Ophthalmscpe head Figure 5: Otscpe and Ophthalmscpes Parts Figure 6: Charging the Otscpe and Ophthalmscpes Versin 1.1 (February 1, 2018) - 6 SOP-OO-01.1
5.0 CONTACTS Research Administratin Facilitatr (Designated KGHRI Staff Member): Lisa McAvy Kingstn General Health Research Institute W.J. Hendersn Centre fr Patient Oriented Research Cnnell 4, Kingstn Health Science Centre (KGH Campus) Kingstn, Ontari K7L 2V7 613-549-6666 ext. 3344 mcavye1@kgh.kari.net Directr, Health Sciences Research: Vernica Harris-McAllister Kingstn General Health Research Institute W.J. Hendersn Centre fr Patient Oriented Research Cnnell 4, Kingstn Health Science Centre (KGH Campus) Kingstn, Ontari K7L 2V7 613-549-6666 ext. 3653 harrismv@kgh.kari.net 6.0 SOP HISTORY SOP Number Date Issued Summary f Revisins SOP-OO-01 01-DEC-2017 Original versin. SOP-OO-01.1 01-FEB-2018 Otscpe instructin manual added t plicy. New appendix added t plicy as Appendix A. Ophthalmscpe instructin manual added t plicy. New appendix added t plicy as Appendix B. Versin 1.1 (February 1, 2018) - 7 SOP-OO-01.1