KleenSpec® Vaginal Specula Illumination System
Contents
1. CAUTION Illumination is intense CAUTION Use only the cleaning methods and disinfection solutions methods described in this manual Clean the device prior to disinfection CAUTION The Illuminator REF 78800 is a biohazard after use Follow good hospital practices and the instructions for cleaning and disinfection of the illuminator within this manual prior to the next usage CAUTION Ensure lamp is installed and fully seated in illuminator throughout cleaning and disinfection process The illuminator assembly is immersible IPX7 provided the lamp is properly installed CAUTION This device complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices As a precaution avoid using this device in close proximity to other equipment U S Federal Law restricts this device to sale by or on the order of a physician To remove all power from the Vaginal Illumination System unplug the external power supply from the wall outlet Illuminator is capable of temporary immersion to a depth of 0 15 to 1 meter at ambient pressure at room and fluid temperatures of 22 C to 43 C There are no user serviceable parts inside the device except the lamp Contact the Authorized Service Center listed on page 13 Consignes de s curit et precautions gt gt gt gt gt gt gt gt gt gt MISE EN GARDE Pour viter les blessures ocul2. A WelchAllyn KleenSpec Vaginal Specula Illumination System REF 78810 Table of Contents Classification 1 Symbol Descriptions 22 perpe S 33 bc YI YJ 1 Warnings and Cautions 2 Consignes de s curit et pr cautions 3 Instructions for USe su coat ei neh ee re 4 KleenSpec Vaginal Specula Illumination System 4 MIAINTENANGE adum scire ue Bare pp er D Preventative Maintenance 5 Lamp Replacement 5 Cleaning Disinfection and Sterilization 6 SIC m 6 DISINFECTION mermas d enm ba l butcher ata 7 SIELIZALION k lan Kn ka en Mee k ss tete 8 DI SDOSA Saai R dk wo e a eee ees dS 8 opecifications 2 Han 9 PAS IRON OR 10 Troubleshooting Guide 11 Troubleshooting Guide Oualified Personnel Only 12 Warranty and Service 13 Limited Warranty esci kk kk a aed e E ERU d T3 Technical Assistance 14 Welch Allyn Service Centers 15 Thank you for purchasing the Welch Allyn 78810 KleenSpec9 Vaginal Specula Illu mination System composing of the 78800 illuminator and the 73410 transformer Please review this manual prior to using this system This updated system replaces the current Welch Allyn 78010 KleenSpec Vaginal Specula Illumination System composed of the 78000 illuminator and the 73305 transfor
3. Cleaning Limited Soak or Cleaning Wipe 2 Follow the disinfecting wipe manufacturer s disinfection instructions on the cord only 3 Thoroughly rinse the cord only with 22 C to 43 C tap water to remove disinfectant 4 Allow to dry Sterilization Refer to the Cleaning Table to identify the appropriate sterilization method prod uct for the expendable illuminator Wet Steam Autoclave Expendable Illuminator REF 78600 1 Clean expendable illuminator as instructed in Cleaning Soak 2 Place the expendable illuminator in the autoclave chamber to allow best exposure to steam Autoclave chamber parameters are as follows e Type 132 Pre vacuum Hi VAC Steam Cycle e Exposure Temperature 132 C to 135 C 270 F to 275 F e Exposure Time 3 5 minutes e Exhaust Time Fast Disposal There are no harmful materials associated with the Illumination System Device is considered a biohazard after use Follow good hospital practices and local ordinances in the disposal of the illuminator There are no risks associated with the disposal of this device after its useful life if it is cleaned and or disinfected per the instructions in this manual Specifications Classification REF 73410 Input Output Category Physical Specifications Illuminator Transformer Illumination Lamp Life Lamp Voltage Lamp IPX Rating Illuminator Transformer Environment Operating Transport Storage Intermit
4. 78600 Refer to Cleaning Table to identify the appropriate cleaning product 1 Disconnect the transformer from the wall outlet and then disconnect the illuminator from the transformer 2 Disconnect illuminator from expendable illuminator and remove the expendable illuminator from the speculum 58600 58601 only Lamp must remain installed during all cleaning and disinfection gt processes 3 Follow the disinfecting wipe manufacturer s instruction and wipe cord illuminator or expendable illuminator completely to remove any residue 4 This process is a rough clean only Refer to disinfection or sterilization for further processing Soak Refer to Cleaning Table to identify the appropriate cleaning product Illuminator REF 78800 and or Expendable Illuminator REF 78600 1 Disconnect the transformer from the wall outlet and then disconnect the illuminator from the transformer 2 Disconnect illuminator from expendable illuminator and remove the expendable illuminator from the speculum 58600 58601 only Lamp must remain installed during all cleaning and disinfection gt processes 3 Follow the cleaning solution manufacturer s instructions and soak the illuminator and or expendable illuminator as instructed Solution temperature is 22 C to 43 C 4 Scrub any area of visible debris with a soft brush and thoroughly rinse the illuminator and or expendable illuminator with 22 C to 43 C tap water to remove the cle
5. manufacture of the component s e llluminator Four digits month then year stamped inverted and to the right of REF 78800 near the lamp e Transformer Four digits month then year stamped or labeled on the prong side of the transformer plug If you are advised to return a product to Welch Allyn for repair or routine maintenance schedule the repair with the service center nearest you Before returning a product for repair you must obtain authorization from Welch Allyn Return Authorization number will be given to you by our service personnel Be sure to note this number on the outside of your shipping box Returns without a return authorization number will not be accepted for service Prior to shipment please clean and disinfect the component as instructed in this manual 13 Welch Allyn 4341 State Street Road Skaneateles Falls NY 13153 Tel 800 535 6663 or 315 685 4560 Fax 815 685 3361 www welchallyn com Part No 718911 Rev A Printed in the U S A
6. the purchaser s risk Welch Allyn will not be responsible for loss associated with the use of any Welch Allyn product that 1 has had the date of manufacture number defaced 2 has been repaired by anyone other than an authorized Welch Allyn Service Representative 3 has been altered 4 has been used in a manner other than in accordance with the instructions or b has been abused or exposed to extreme environmental conditions THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY IMPLIED WARRANTY OR MERCHANTABILITY FITNESS FOR PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESSED OR IMPLIED WELCH ALLYN WILL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE SALE USE OR IMPROPER FUNCTIONING OF THE INSTRUMENTATION REGARDLESS OF THE CAUSE THE DAMAGES FOR WHICH WELCH ALLYN WILL BE RESPONSIBLE INCLUDE BUT ARE NOT LIMITED TO LOSS OF REVENUE OR PROFIT DOWNTIME COSTS AND LOSS OF USE OF THE INSTRUMENTATION Technical Assistance If you have an equipment problem that you cannot resolve you may call the Welch Allyn Service Center nearest you for assistance For Technical Support or to obtain information about any Welch Allyn product contact Welch Allyn Technical Support www welchallyn com support or visit www welchallyn com about company locations htm Prior to contacting Welch Allyn or its service center please refer to the following areas of the illuminator and or transformer to identify the date of
7. 05 59006 and 58600 58601 with expendable illuminator 78600 for gynecological and obstetric procedures The transformer plug REF 73410 provides power from the hospital grade wall outlet to the illuminator assembly REF 78800 which houses the lamp REF 08800 This provides illumination to the specula and expendable illuminator see above This device is intended for use only with appropriate accessories see above This product is for use with the Welch Allyn KleenSpec Single Use Vaginal Specula only Do not use the illuminator for any other use Lamp is hot and can cause a burn if used outside of the vaginal specula Assemble the transformer to the illuminator as shown below The illuminator then slides into the appropriate Welch Allyn accessory listed above Verify all connections are made prior to applying power with the on off switch pecula see above Push down to increase angulation Push down to we N elevation g Y A Specula see REF 78600 2 pecula Transformer Plug Erin nn nn nn s Push up to increase 22 X a elevation REF 73410 REF 08800 On Off Switch a SY Energizes the lamp A LA SP te HIT nn n n System REF 78800 P Maintenance Preventative Maintenance Monthly examine cords connections and transformer case for wear or damage After every use clean the unit according to the Cleaning Disinfection and Steri
8. ION S assurer que la lampe est bien install e et mont e dans l illuminateur pendant toute la dur e de la proc dure de nettoyage et de d sinfection Le syst me illuminateur peut tre immerg IPX7 condition que la lampe soit correctement mont e ATTENTION L instrument satisfait aux normes actuelles en vigueur concernant les interf rences lectromagn tiques et ne devrait ni affecter ni tre affect par les autres appareils Par mesure de pr caution viter d utiliser cet instrument tout pr s d un autre appareil La loi f d rale des tats Unis limite la vente de cet instrument un m decin ou sur ordonnance d un m decin Pour teindre compl tement l illuminateur vaginal d brancher l alimentation ext rieure de la prise murale L illuminateur peut tre plong temporairement une profondeur variant entre 0 15 et 1 m tre la pression atmosph rique une temp rature ambiante et du liquide d immersion comprise entre 22 C et 43 C Mis part la lampe cet instrument ne poss de aucun composant que l utilisateur ait entretenir Contacter le centre de service agr indiqu sur la page 13 Instructions for Use KleenSpec Vaginal Specula Illumination System The KleenSpec Vaginal Specula Illumination System REF 78810 consisting of the illuminator REF 78800 and transformer REF 73410 are designed to work with the following Welch Allyn specula 580005 58001S 580045 590XS 59000 59001 59004 590
9. aires ne pas regarder dans le rayon MISE EN GARDE La lampe est nocive au toucher pour la peau Laisser la lampe refroidir pendant 5 minutes avant de la remplacer La lampe g n re beaucoup de chaleur et doit rester teinte jusque juste avant et imm diatement apr s utilisation Ne pas placer l illuminateur sur une surface inflammable si la lampe est allum e MISE EN GARDE D brancher le transformateur de la prise murale avant toute maintenance MISE EN GARDE L usage de cet instrument est strictement limit aux sp culums vaginaux Welch Allyn KleenSpec usage unique Ne pas utiliser l illuminateur a toute autre fin La lampe est chaude et peut causer des br lures si elle est utilis e sortie du sp culum vaginal MISE EN GARDE L illuminateur pour sp culums vaginaux KleenSpec ne peut tre utilis en pr sence d un m lange anesth sique inflammable gazeux base d air d oxyg ne ou d oxyde nitreux Une explosion pourrait se produire ATTENTION Utiliser seulement les m thodes de nettoyage et les solutions et m thodes de d sinfection d crites dans ce manuel Nettoyer l instrument avant de le d sinfecter ATTENTION L clairage est intense ATTENTION L illuminateur REF 78800 repr sente un danger biologique apr s utilisation Appliquer les bonnes pratiques hospitali res et respecter les consignes de nettoyage et de d sinfection de l illuminateur explicit es dans ce manuel avant l usage suivant ATTENT
10. aning solution Rough dry the illuminator and or expendable illuminator The illuminator and or the expendable illuminator is now ready for disinfection Limited Soak Transformer REF 73405 or REF 73410 Refer to Cleaning Table to identify the appropriate cleaning product 1 Disconnect the transformer from the wall outlet and then disconnect the illuminator from the transformer 2 Follow the cleaning solution manufacturer s instructions and soak the cord only in the solution as instructed Solution temperature is 22 C to 43 C 3 Scrub any area of visible debris with a soft brush and thoroughly rinse transformer cord only with 22 C to 43 C tap water to remove the cleaning solution 4 Rough dry transformer 5 The transformer is now ready for disinfection Oo Disinfection Refer to the Cleaning Table to identify the appropriate disinfection method prod uct for the illuminator expendable illuminator and or transformer Illuminator REF 78800 and or Expendable Illuminator REF 78600 1 Clean illuminator and or expendable illuminator as instructed in Cleaning Soak or Cleaning Wipe 2 Follow the disinfecting wipe manufacturer s disinfection instructions 3 Thoroughly rinse illuminator and or expendable illuminator with 22 C to 43 C tap water to remove disinfectant 4 Allow to dry Transformer REF 73405 or REF 73410 DO NOT IMMERSE THE TRANSFORMER PLUG 1 Clean transformer as instructed under
11. ct and socket threads Verity voltage reads approximately 4 6 volts DC with REF 73405 or AC with REF 73410 Only properly trained personnel shall perform this test Lamp does not light Verify the voltage supplied to the transtormer outlet meets the requirements stated in this manual Improper voltage supplied to the transformer Light output seems low This guide is intended to provide assistance towards determining the fault condition of this product Please contact the authorized Welch Allyn Service Center listed within the product owners manual for additional assistance Warranty and Service Limited Warranty Instrumentation purchased new from Welch Allyn Inc Welch Allyn is warranted to be free from original defects in material and workmanship under normal use and service for a period of one year for Welch Allyn KleenSpec Vaginal Specula Illumination System REF 78810 comprised of the illuminator REF 78800 and the transformer REF 73410 from the date of first shipment from Welch Allyn This warranty shall be fulfilled by Welch Allyn or its authorized representative repairing or replacing at Welch Allyn s discretion any such defect free of charge for parts and labor Welch Allyn must be notified via telephone of any defective product and the item must be immediately returned with an RMA number provided by Welch Allyn securely packaged and postage prepaid to Welch Allyn Loss or damage in shipment shall be at
12. lization section of this manual Lamp Replacement A The lamp is the only user serviceable part on the Illumination gt System Replace the lamp when there is insufficient illumination CCW 1 Disconnect the transformer from the wall outlet and then disconnect the illuminator from the transformer 2 Allow lamp to cool for a minimum of 5 minutes and remove the lamp by unscrewing counterclockwise CCW 3 Inspect the lamp socket of the illuminator for damage or irregularities Contact the authorized Service Center if any irregularities are found Replace with Welch Allyn REF 08800 lamp only Verify that the lamp o ring is present and free from damage or debris prior to installation If o ring is missing or damaged replace the lamp 6 Install by screwing clockwise CW pus Cleaning Disinfection and Sterilization Transformer Expendable REF 73405 or Illuminator REF 73410 REF 78600 CaviWipe Metrizyme le Limited Yes Caviwipe Intermediate Intermediate Level Level Level Do not immerse the transformer plug Follow instructions per this manual The Expendable llluminator s ability to transmit light will degrade after repeated autoclave cycles approximately 20 and will eventually need replacement Illuminator REF 78800 isi Intermedi Disinfection termediate Cleaning Wipe Transformer REF 73405 or REF 73410 Illuminator REF 78800 Expendable Illuminator REF
13. mer Classification Class Il Type BF Applied Part Ordinary Equipment Sterilize only as directed in Cleaning Section Non continuous Operation Symbol Descriptions Caution high temperatures A Warning Consult Directions for Use N Caution Lamp On Lamp Off Caution high intensity light Type BF Applied Part Boeg w X Alternating Current Direct Current ia Double Insulation Illuminator is protected against the effects of Transformer Plug Not IPX7 temporary immersion in IPX protected from the ingress of water and the solutions water described in this manual Warnings and Cautions A gt gt gt gt gt gt PP gt WARNING To avoid eye injury do not look into the beam WARNING Lamp is harmful to skin if touched Allow lamp to cool for 5 minutes before replacing Lamp generates heat and should remain off until just prior to and immediately after use Do not place illuminator onto a flammable surface if lamp is illuminated WARNING Disconnect transformer from outlet prior to any maintenance WARNING This product is for use with the Welch Allyn KleenSpec Single Use Vaginal Specula only Do not use the illuminator for any other use Lamp is hot and can cause a burn if used outside of the vaginal specula WARNING KleenSpec Vaginal Specula Illumination System is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide An explosion may result
14. oes not stay retained into 580 series specula or 78600 expendable illuminator Possible damage to the Inspect retention wings for illuminator retention damage Replace illuminator wings REF 78800 Illuminator does not stay plugged llluminator transtormer into the interconnect plug is transformer damaged cord Faulty Lamp Replace with a new lamp Light output Inspect lamp lens for debris and seems low Dirty lamp lens yee P This guide is intended to provide assistance towards determining the fault condition of this product Please contact the authorized Welch Allyn Service Center listed within the product owners manual for additional assistance Inspect interconnect plug for damage Replace either or both REF 73405 REF 73410 or REF 78800 Troubleshooting Guide Qualified Personnel Only rT Nopowertothe power to the Verify that power is supplied to that power is supplied to transtormer outlet transtormer outlet Test the voltage supplied through the transformer at the cord end Verity the voltage reads Faulty Transtormer approximately 4 7 volts DC REF 73405 or 4 7 volts AC REF 73410 Only properly trained personnel shall perform this test Verity that the illuminator is faulty by replacing with a new illuminator or with the switch in the on position and power supplied through the transformer above remove lamp and measure the Faulty Illuminator voltage between the lamp socket center conta
15. tent Operation Vag Spec and Illuminator Approvals Class Il Type BF Applied Part 120V 60Hz 100mA 4 7 VAC 850mA Not AP APG Equipment 91 4 cm 36 in 183 cm 72 in 100 hours 4 6 V Welch Allyn part no 08800 IPX7 IPXO 10 C to 35 C 50 F to 95 F 95 RH D00 hPa to 1060 hPa 20 C to 49 C 2 F to 120 F 95 RH 500 hPa to 1060 hPa 10 minutes on max 5 minutes off min CERTIFIED TO CAN CSA STD C22 2 NO 601 1 CONFORMS TO IEC 60601 1 IEC60601 1 2 UL 60601 1 STD 2601 1 Device Directive The CE Mark on this product indicates it has been tested to and conforms with the provisions noted with the 93 42 EEC Medical EC REP Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan County Meath Republic of Ireland Troubleshooting Guide Power switch is in the off Verify the power switch is in the position on position Refer to manual Verify that the illuminator is properly plugged into transformer cord Transformer is not Verify the transformer is properly plugged in plugged into the outlet E N Faulty Lamp Replace with anew lamp Verity that the lamp is secured into Loose Lamp the illuminator Verify that the lamp is a REF Mono amb 08800 Welch Allyn lamp Inspect the lamp and the o ring for Damaged Lamp damage Replace with REF 08800 lamp if damage is found Illuminator is not plugged into the transformer Illuminator d
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