Storz HOPKINS Instruction Manual
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Storz HOPKINS Instruction Manual

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Summary of Contents for Storz HOPKINS

  • Page 1 ® HOPKINS elescopes Instruction Manual...
  • Page 2 KARL STORZ instruments Thank you for placing confidence in the name of KARL STORZ. As with all our other products, we have invested years of experience and much care in production of this telescope. You, and your organi- zation, have chosen a modern high-quality KARL STORZ instrument.
  • Page 3 70° Lateral 90° Lateral 120° Retrospective 45° 30° Wide Angle 12° Telescopes ® ® KARL STORZ HOPKINS and HOPKINS II Telescopes are provided both auto- clavable and non-autoclavable.To iden- tify the difference please note “AUTO- CLAV” marked on the eyepiece.

  • Page 4: Table Of Contents

    Contents Illustrative Description......3 Important Information......5 General Information for the Safe Use of KARL STORZ Telescopes ....7 Inspection ..........10 Handling..........12 Operating Instructions .......13 Cleaning, Disinfection and Sterilization.........15 Manual Cleaning ........16 Automated Washing......18 Inspection ..........19 Disinfection Instructions.....20 Sterilization Instructions .....24 Inspection Upon Receipt ....30 Maintenance and Repair....30...

  • Page 5: Important Information

    ® care of KARL STORZ HOPKINS ® HOPKINS II Telescopes are described ® in this manual. The KARL STORZ HOPKINS ® and HOPKINS II Telescopes are delicate optical instruments and should be handled with care. Improper use during surgical procedures will result in damage or breakage of the telescope.
  • Page 6 The KARL STORZ HOPKINS and HOP- ® KINS II Telescopes are compatible with any light sources and light cables marketed by KARL STORZ Endoscopy America, Inc. ® CAUTION: The KARL STORZ HOPKINS ® and HOPKINS II Telescopes are provided NON-STERILE, and must be cleaned,...
  • Page 7 General Information for the Safe Use of KARL STORZ Telescopes User qualifications These instruments may only be used by licensed physicians and qualified medical personnel who have been trained in their use. Warnings and precautions Please read this manual carefully. It is...

  • Page 8: General Information For The Safe Use Of Karl Storz Telescopes

    General Information for the Safe Use of KARL STORZ Telescopes (Continued) Note: A note provides additional infor- mation regarding the safe operation of the device. Description of Device ® The KARL STORZ HOPKINS and HOP- ® KINS II telescopes are reusable rod lens...
  • Page 9 ® WARNING: KARL STORZ HOPKINS ® and HOPKINS II telescopes are provided NONSTERILE and must be thoroughly cleaned and sterilized according to validated infection control procedures prior to use and subsequent reuse. WARNING: High level disinfection is recommended ONLY for telescopes...

  • Page 10: Inspection

    ® Inspection of the HOPKINS ® HOPKINS II Telescopes: Inspection ® of the KARL STORZ HOPKINS ® HOPKINS II Telescopes for signs of damage should be performed before and after every surgical procedure. Working Shaft Inspect the entire surface of the working...
  • Page 11 NON-STERILE and must be cleaned, dis- infected and/or sterilized prior to initial use and subsequent reuse. CAUTION: Steam sterilize only KARL STORZ telescopes marked 'AUTOCLAV'! Non-autoclavable telescopes will suffer irreparable damage. CAUTION: Do not use Immediate-Use Steam (FLASH) sterilization for any KARL ®...

  • Page 12: Handling

    If there is any doubt about whether the telescopes are safe to use, please contact your sales representative or the Technical Support Staff directly at KSEA (1-800- 421-0837). ® Handling of HOPKINS ® HOPKINS II Telescopes ® ® KARL STORZ HOPKINS and HOPKINS II Telescopes are delicate instruments.

  • Page 13: Operating Instructions

    Trays and containers, which are suit- able for storage, transport and ster- ilization, are available in various ® lengths for KARL STORZ HOPKINS ® and HOPKINS II Telescopes. Operating Instructions Be sure that the telescopes have been properly cleaned, disinfected and/or sterilized prior to use.
  • Page 14 Attach the light cable to the fiber optic light post on the telescope. KARL STORZ recommends that the appropriate size light cable be used to minimize the heat energy gener- ated from the light source. Use of...
  • Page 15 Cleaning, Disinfection and Sterilization Instructions: WARNING: The KARL STORZ HOP- ® ® KINS and HOPKINS II Telescopes should be thoroughly cleaned, disin- fected and/or sterilized according to validated infection control procedures prior to use and subsequent reuse. CAUTION: DO NOT soak the telescope in any solution (including water) for longer than 60 minutes.
  • Page 16 (e.g. Enzol), diluted to proper concentration per manufacturer's instructions. ® Manual Cleaning for HOPKINS ® and HOPKINS II Telescopes CAUTION: WEAR PROTECTIVE GLOVES, CLOTHING AND A FACE MASK FOR CLEANING OF CONTAMINATED TELE- SCOPES.
  • Page 17 CAUTION: DO NOT clean the KARL ® ® STORZ HOPKINS and HOPKINS II Tel- escopes in an ultrasonic bath. Remove light cable adapters before cleaning. Do not clean or rinse tele- scopes with other instruments to pre- vent damage to the telescope.

  • Page 18: Manual Cleaning

    Dry all channels with clean, dry, oil- free compressed air. 10. Continue to the Inspection Section. Automated Washing ® WARNING: DO NOT process HOPKINS telescopes with channels through an automated washer-disinfector. WARNING: The telescope must still be sterilized or high-level disinfected after processing through the washer- disinfector.

  • Page 19: Inspection

    Automated Cleaning Place the telescope in a compatible tray (P/N 39305 C1S/C2S/L1S/L2S). Process in the washer-disinfector with the following minimum cycle param- eters: Cycle Phase Cycle Parameter Pre-Wash 1 1 minute, cold water Pre-Wash 2 1 minute, cold water 6 minutes, 55˚C, alkaline cleaning Wash 1 detergent (e.g.
  • Page 20 Do not use the endoscope if it is dam- aged or is difficult to use. The endo- scope should be returned to KARL STORZ for repairs or replacement. High Level Disinfection Instructions for KARL STORZ Telescopes...
  • Page 21 KARL STORZ does not recommend the ® use of CIDEX PLUS or other 28-day room temperature glutaraldehyde solutions for manual high level disinfection, as they contain high concentrations of surfactants, which may dry and crystallize on the tele- scopes if they are not thoroughly rinsed.

  • Page 22: Sterilization Instructions

    Cleaning, Disinfection and Sterilization (Continued): (Activated Dialdehyde) Solution Test Strips to verify the solution is above the minimum effective concentration (MEC). Test the solution prior to each use. Do not use activated solution beyond stated 14 day reuse life. Record the date of activation and the expiration date on the container.
  • Page 23 Completely immerse the telescope in the undiluted 2.4% glutaraldehyde solution for a minimum of 45 minutes at 25˚C (77˚F), not to exceed 1 hour. 0.55% ortho-Phthalaldehyde (e.g. CIDEX OPA) Completely immerse the telescope in the undiluted solution for a mini- mum of 12 minutes at 20˚C (68˚F) or higher, not to exceed 1 hour.
  • Page 24 ® HOPKINS and HOPKINS II Telescopes. To achieve the desired sterility assurance level (SAL) of 10 , KARL STORZ recom- ® mends the following: steam, STERRAD sterilization methods. CAUTION: Steam sterilize only KARL STORZ telescopes marked 'AUTOCLAV'! Non-autoclavable telescopes will suffer irreparable damage.
  • Page 25 ® STERRAD System KARL STORZ telescopes are compatible ® with the STERRAD 100S, NX (Standard Cycle) and 100NX (Standard Cycle) ster- ® ilization systems. The STERRAD...
  • Page 26 Instructions for Use guide. If using a sterilization container, use filters as directed by manufacturer in container Instructions for Use guide. Note: Instruments that KARL STORZ has determined to be compatible with ® the STERRAD System sterilization process have been validated with at least ®...
  • Page 27 Do not allow any items to touch the wall of the sterilizer. ® Please consult the STERRAD System Operators Manual for detailed instruc- tions for use. Steam Sterilization WARNING: ONLY KARL STORZ HOP- ® ® KINS and HOPKINS II TELESCOPES marked “AUTOCLAV” can be steam sterilized.
  • Page 28 In- structions for Use guide. If using a sterilization container, use filters as directed by manufacturer in container Instructions for Use guide. KARL STORZ has validated the fol- lowing steam sterilization parameters:...
  • Page 29 • Pre-vacuum: Pre-vacuum or high vacuum sterilization consists of four basic phases: a condi- tioning phase, an exposure phase, an exhaust phase and a drying phase. The conditioning phase removes air from the chamber by pulling a vacuum and then warms the instruments by injecting steam.

  • Page 30: Inspection Upon Receipt

    Inspection Upon Receipt THOROUGHLY INSPECT SHIPMENT IMMEDIATELY UPON ARRIVAL. Although KARL STORZ products are care- fully packed to minimize in-transit damage, all shipments should be carefully exam- ined upon receipt and if a product is damaged, Customer must document the nature and extent of the damage and immediately contact KSEA.

  • Page 31: Return Policy

    (2) the telephone number and the person to contact; (3) the applicable P.O. number; (4) the KARL STORZ catalog number and, if applicable, the serial number for each product; and, (5) the reason for the return.
  • Page 32 Return Policy (Continued) items are unused, in resalable condition and in their original product container. All products returned after 30 days from the date of invoice are subject to a 15% re- stocking fee. The following products may not be re- turned for credit or exchanged: (1) products held longer than 90 days from invoice date;...
  • Page 33 All repairs carry a 90 day warranty. Exchange products carry the applicable KARL STORZ product warranty. If the damaged product is not returned within thirty (30) days of receipt of the replace- ment product, Customer will be invoiced for the full list price of the replacement.

  • Page 34: Warranty Policy

    Except as otherwise provided herein and/or by the applicable warranty infor- mation for a specific product or type of product, all KARL STORZ-branded prod- ucts are generally warranted to be in good working order at the date of delivery and free from defects in workmanship and materials for one (1) year from date of delivery.
  • Page 35 KSEA, nullifies and otherwise voids all applicable KARL STORZ warranties. Repair or replace- ment of a KARL STORZ product shall not extend the term of any applicable warranty. The remedies provided herein are Cus- tomer's exclusive remedies under this Warranty Policy.

  • Page 36: Limitation Of Liability

    (lost profits), or from any other cause, what- soever, in connection with or arising from the purchase, sale, lease, rental, installation or use of such KARL STORZ products, even if Customer has been advised of the possibility of such damages.
  • Page 37 SOME JURISDICTIONS DO NOT ALLOW EXCLUSIONS AND DISCLAIMERS OF CERTAIN WARRANTIES OR LIMITA- TIONS OF LIABILITY, SO THE LIMITA- TIONS AND/OR EXCLUSIONS, SET FORTH IN THESE TERMS AND CONDI- TIONS, MAY NOT APPLY. IN THAT EVENT, KSEA’S LIABILITY WILL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW IN THE SUBJECT JURISDICTION.
  • Page 38 Appendix I Urology Indications for Use: The KARL STORZ ® ® HOPKINS and HOPKINS II Telescopes are to be used for visualization of the surgical site during diagnostic and ther- apeutic urology procedures. Contraindications: The KARL STORZ ® ® HOPKINS...

  • Page 39: And Throat

    Ear, Nose and Throat Indications for Use: The KARL STORZ ® ® HOPKINS and HOPKINS...
  • Page 40 Appendix I (Continued) Arthroscopy Indications for Use: The KARL STORZ ® ® HOPKINS and HOPKINS II Telescopes are for use during diagnostic and thera- peutic arthroscopic surgical procedures in the knee, shoulder, elbow, wrist, ankle, jaw and hip. Contraindications: The KARL STORZ ®...
  • Page 41 Gynecology (Laparoscopy) Indications for Use: • unexplained pelvic pain (acute, chronic) • infertility work-up • tubal sterilization • unexplained primary or secondary amenorrhea • diagnosis and/or treatment of ectopic pregnancy • evaluation, diagnosis and/or treatment or small pelvic tumors, including myomata •...
  • Page 42 Appendix I (Continued) Other Relative Contraindications: • cardiac disease • diaphragmatic hernia • previous abdominal surgery • obesity • thin nulliparious patient • pregnancy greater than 16 week size or abdominal mass of comparable size • chronic obstructive lung disease •...
  • Page 43 • Electrosurgical Safety: Inadvertent burns can occur when the appropriate patient return path is obstructed. Inadvertent burns may also occur as a result of capacitive coupling. WARNING: Although not reported in the current literature with the use of monopolar resectoscopes when used with non-electrolytic distending media, air/gas emboli have been reported with the use of bipolar resectoscopes and...
  • Page 44 Appendix I (Continued) Absolute Contraindications for Use: • acute Pelvic Inflammatory Disease (PID) Relative Contraindications for Use: • inability to distend uterus • cervical/vaginal infection • uterine bleeding or menses • known pregnancy • invasive carcinoma of the cervix • recent uterine perforation •...
  • Page 45 Absolute Contraindications for Use: • acute Pelvic Inflammatory Disease (PID) Relative Contraindications for Use: • inability to distend uterus • cervical/vaginal infection • uterine bleeding or menses • known pregnancy • invasive carcinoma of the cervix • recent uterine perforation •...
  • Page 46 Appendix I (Continued) Relative Contraindications to Hysteroscopic Myomectomy Hysteroscopic myomectomy, whether by laser or electrosurgery, should not be under- taken before adequate training, precep- torship and clinical experience. The following are clinical conditions that can significantly complicate hysteroscopic myomectomy: • severe anemia •...
  • Page 47 Neurology Indications for Use: KARL STORZ Neu- roendoscopes are indicated for use during neuroendoscopic surgical procedures for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures. Contraindications: • Use of KARL STORZ Neuroendoscopes are contraindicated whenever neuroen- doscopy is contraindicated.
  • Page 48 Appendix I (Continued) • Insufficient cleaning may compromise the sterility of the neuroendoscope. • The neuroendoscope must be sterilized after each use. • Disinfection does not sterilize neuroen- doscopes. • The use of the neuroendoscope with cables and accessories may produce tension and torquing forces on the neu- roendoscope during use.
  • Page 49 Precautions: All procedures using KARL STORZ Neuro -endoscopes should be performed by a qualified neurosurgeon with neuroendo- scopic experience. Dentistry Indications for Use: The KARL STORZ ®...
  • Page 50 Appendix II Cleaning Accessories available from KSEA Cleaning Brushes: 27648 A Cleaning brush. Length: 50 cm 27650 A Same. Length: 35 cm. Large size 27662 Grasping forceps for careful handling of instruments Protective tubes (for storage and transport only): 723750 A Length, 11.9 cm 723750 B Length, 19.7 cm 723750 E Length, 31.9 cm 723750 H Length, 46.8 cm...
  • Page 52 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon: +49 (0) 7461 708-0 Telefax: +49 (0) 7461 708-105 Email: info@karlstorz.com Web: www.karlstorz.com IM-000003-17.0 (11/19)

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