Contained Tissue Extraction (CTE) – Pneumoliner™ Containment Device

Contraindications

  1. Do not use on tissue that is known or suspected to contain malignancy
  2. Do not use for removal of uterine tissue containing suspected fibroids in patients who are: post-menopausal or over 50 years of age; or candidates for en bloc tissue removal, through the vagina or via a mini-laparotomy incision.
  3. Do not use in women with undiagnosed uterine bleeding
  4. Do not use this device on patients with know or suspected allergies to polyurethane
  5. Do not use where the abdominal wall thickness is larger than 10 cm

Warnings

Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.

  1. The risk of occult cancer, including uterine sarcoma, increases with age, particularly in women >50 years of age. This information should be shared with patients when considering surgery with the use of these devices.
  2. Do not cut, puncture or scrape the PneumoLiner with the morcellator tip or tenaculum/grasper.
  3. Do not use if package or printed information is damaged. The device is supplied sterile; inspect the package to ensure it is intact.
  4. This device is single-use only. Do not re-sterilise or reuse any portion of this device.
  5. Re-use or re-sterilisation may create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  6. Check for and remove adhesions that may inhibit proper placement of the device.
  7. The Pneumoliner must be fully inflated (12 - 15 mmHg) to minimize the risk of damage to the bag and adjacent organs during morcellation.
  8. At all times prior to morcellating, make sure the tenaculum/grasper is within view when grasping tissue, to prevent it contacting the PneumoLiner.
  9. The tip of the morcellator must be brought into view, prior to and during each activation to provide confirmation of the position of the morcellator tip and its proximity to the PneumoLiner.
  10. With the tip of the morcellator in view, prior to activating the morcellator, confirm that the tissue specimen is centered within the Pneumoliner.
  11. Do not bring the morcellator tip into contact with the PneumoLiner.
  12. To prevent risk of contamination, do not re-attach the Boot following removal of the PneumoLiner.
  13. Any abdominal incision introduces a risk of abdominal hernia.

Precautions:

  1. Please read all instructions prior to use.

For further information, please refer to the Pneumoliner™ Containment Device IFU-WA90500US

 

EVIS X1™ Endoscopy System

The EVIS X1™ endoscopy system is not designed for cardiac applications. Other combinations of equipment may cause ventricular fibrillation or seriously affect the cardiac function of the patient. Improper use of endoscopes may result in patient injury, infection, bleeding, and/or perforation. Complete indications, contraindications, warnings, and cautions are available in the Instructions for Use (IFU). 

TXI™ Technology:
TXI™ technology is not intended to replace histopathological sampling as a means of diagnosis.
TXI is a trademark of Olympus Corporation, Olympus America, Inc., and/or their affiliates.

RDI™ Technology:
RDI™ technology is not intended to replace histopathological sampling as a means of diagnosis.
RDI is a trademark of Olympus Corporation, Olympus America, Inc., and/or their affiliates.

BAI-MAC™ Technology:
BAI-MAC™ technology is not intended to replace histopathological sampling as a means of diagnosis.
BAI-MAC is a trademark of Olympus Corporation, Olympus America, Inc., and/or their affiliates.

NBI™ Technology:
NBI™ technology is not intended to replace histopathological sampling as a means of diagnosis.
NBI is a trademark of Olympus Corporation, Olympus America, Inc., and/or their affiliates. 

GIF-1100 Gastroscope:
Improper use of endoscope may result in patient injury, infection, bleeding, and/or perforation. For complete indications, contraindications, warnings, and cautions, please reference full Instructions for Use (IFU) that accompanied your product.

CF-HQ1100DL/I Colonoscope:
Improper use of endoscope may result in patient injury, infection, bleeding, and/or perforation. For complete indications, contraindications, warnings, and cautions, please reference full Instructions for Use (IFU) that accompanied your product.

 

Contained Tissue Extraction (CTE) – BLUE ENDO® moresolution® Laparoscopic Power Morcellator

Contraindications

  1. The Morcellator may not be used in the treatment of malignant tumors/tissue or for vascularized tissue.
  2. Laparoscopic power Morcellators are contra¬indicated in gynecologic surgery in which the tissue to be morcellated is known or suspec¬ted to contain malignancy.
  3. Laparoscopic power Morcellators are con¬traindicated for removal of uterine tissue containing suspected fibroids in patients who are:
    • post-menopausal, or
    • over 50 years of age, or
    • candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.
  4. It may also not be used to prepare tissue.
  5. Do not use in women with undiagnosed uterine bleeding.

Warnings

WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power Morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

WARNING: Laparoscopic power morcellators should only be used with a containment system. The containment system should be compatible with the laparoscopic power morcellator.

The Morcellator may not be used in the treatment of malignant tumors/tissue or for vascularized tissue.

 

Guardenia™ Contained Extraction System for Extracorporeal Manual Morcellation

Contraindications

  1. Guardenia is contraindicated for use with laparoscopic power and manual morcellators.
  2. Guardenia is contraindicated for use with powered cutting devices (i.e. power morcellators, electrosurgical and laser instruments) and when in the judgement of the physician, use of such a device would be contrary to the best interest of the patient.
  3. Do not use this device on patients with known or suspected allergies to polyurethane

Warnings

  1. Do not cut, puncture or scrape the Bag with any sharp instrument.
  2. Do not use if package or printed information is damaged. The device is supplied sterile; inspect the package to ensure it is intact.
  3. This device is single-use only. Do not re-sterilize or reuse any portion of this device. Re-use or re-sterilization may create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  4. If the bag and its contents are too large to be extracted or morcellated, carefully enlarge the incision site for ease of removal
  5. Perforation of the Guardenia Bag may compromise the ability of the device to contain the specimen.
  6. Check for and remove adhesions that may inhibit proper placement of the device.
  7. Ensure no viscera is located within the opening ring of the bag prior to bag closure to prevent risk of inadvertent tissue damage.
  8. To minimize the chance of damage, a curved scalpel blade (type 10 or similar) should be used.

For further information, please refer to the Guardenia™ Containment System for Manual Morcellation IFU-GAR-1

 

EndoClot® Polysaccharide Hemostatic System (PHS) & Submucosal Injection System (SIS)

EndoClot® PHS

Contraindications

  • EndoClot® PHS is contraindicated in patients who are sensitive to starch or starch-derived materials. Also contraindicated in patients who have gastrointestinal fistulas, are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment.
  • Use of EndoClot PHS in pediatric populations and pregnant women has not been studied. To use EndoClot PHS in these populations is at the discretion of the healthcare professional.

Warnings

  • EndoClot® PHS is not intended as a substitute for good surgical practice, and in particular, the proper use of conventional procedures for hemostasis. 
  • Combined use of EndoClot PHS with other topical hemostatic agents has not been studied in controlled clinical trials.
  • EndoClot PHS is designed for single use only.
  • Absorbable Modified Polymer (AMP®) particles can absorb water from blood. This dehydration process causes a high concentration of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.), which accelerates the normal, physiologic clotting cascade. When in contact with blood, AMP particles support the formation of a gelled, matrix which provides a mechanical barrier to further bleeding. AMP particles can be degraded by human body.
  • EndoClot PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.
  • Ensure gastrointestinal lumen is not distended when EndoClot PHS is used in the gastrointestinal tract as excessive luminal pressure may be generated by the gas source to cause bowel rupture and air embolism.
  • Do not inject AMP® particles into the bile duct or pancreatic duct.
  • Do not use this device for any purpose other than stated use.

Precautions

  • EndoClot® PHS is not recommended as a primary treatment for coagulation disorders.
  • EndoClot PHS is intended to be used in a dry state. Contact with fluids prior to application will result in the loss of hemostatic efficacy.
EndoClot® SIS

Contraindications

  • Patients with known sensitivity to starch and starch-derived materials.
  • Do not inject into blood vessels.

Warnings

  • EndoClot® SIS is a single-use medical device. Any agent not injected during the procedure should not be reused for another endoscopic procedure. 
  • Compatibility of the agent has not been tested with other substances.

 

ESD (Products and Procedures)

ESD is a technically demanding procedure and use of associated products may result in patient injury, bleeding and/or perforation.

 

HICURA™ Laparoscopic Hand Instruments

Contraindications

There are no absolute contraindications against laparoscopy/thoracoscopy which would not equally apply to open surgery in general. The operating physician must judge according to professional standards whether a specific procedure is appropriate.

Known relative contraindications against laparoscopy include:

  • previous surgery/severe adhesions
  • pulmonary diseases
  • heart diseases
  • pregnancy

Laparoscopy may also be contraindicated by the following conditions depending on their severity or extent.

  • Class IV cardiac decompensation
  • Bowel obstruction
  • Ileus
  • Cardiac disease
  • Intraperitoneal hemorrhage
  • Diaphragmatic hernia
  • Infection with acute peritonitis
  • Previous abdominal surgery
  • Obesity
  • Thin nulliparous patient
  • Chronic obstructive lung disease
  • Liver failure with established collateral vessels

There are no known additional contraindications. The intended use and contraindications of the equipment used in combination with the hand instrument must be observed.
 

General Warnings and Cautions

The following warnings and cautions apply to the general handling of the product. This information is to be supplemented by the dangers, warnings and cautions given in each chapter of the IFU, in the "System Guide Endoscopy" or in the instructions for use of any product being used with this product.

Risk of injury to the patient and/or the user

An insufficient understanding of the dangers, warnings, cautions, and instructions can result in serious injury or damage to the product.

  • Make sure to have the complete set of instructions for use.
  • Follow the dangers, warnings, cautions, and instructions in the "System Guide Endoscopy".
  • In case of conflicting information, follow the dangers, warnings, cautions, and instructions in this document.

There is a risk of injury to the patient and/or the user caused by unauthorized repairs and product modification.

  • Do not attempt to repair or modify the product.

Using incompatible equipment may lead to injury of the patient and/or the user as well as damage to the product.

  • For information on compatible equipment, refer to the chapter "Compatible equipment" on page 39 of the IFU.

The use of a damaged product or of a product with improper functioning may cause an electric shock, mechanical injury, infection, and/or thermal injury.

  • Before each use, observe the instructions in the section "Inspection" on page 22 of the IFU.
  • Do not use a damaged product or a product with improper functioning.
  • Replace a damaged product or a product with improper functioning.

Exceeding the rated accessory voltage may damage the insulation. There is a risk of thermal injury.

  • The maximum output voltage of the electrosurgical generator must not exceed the rated accessory voltage of any of the HF accessories used during the procedure.
  • Set the output power of the electrosurgical generator to the minimum level that is necessary for the procedure.
     

Risk of injury to the patient

There is a risk of injury to the patient due to malfunction of the equipment.

  • Always have spare equipment available.

There is a risk of an electric shock when using endoscopic equipment or when using endoscopic equipment in combination with energized endotherapy devices. The patient leakage currents may be additive.

  • Before each use, check the applied part classification of the endoscopic equipment and especially the energized endotherapy devices used during the procedure.
  • Only use endoscopic equipment or endoscopic equipment in combination with energized endotherapy devices that meet at least the same requirements of applied part classification. This is particularly important if a type CF applied part endoscope is used. In this case a type CF applied part energized endotherapy device should be used to minimize total leakage current.
  • For the applied part classification, refer to the respective instructions for use.
     

For further information please refer to the HICURA™ Bipolar Hand Instrument and Monopolar Hand Instrument Instructions for Use (2013).

 

iTind™ System

The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
 

CONTRAINDICATIONS

  • Active urinary tract infection or prostatitis.
  • Artificial urinary sphincter or any implant (metallic or nonmetallic) within the urethra.
  • Any patient condition which, to the implanting physician's opinion, may cause complications during the deployment of the device.
  • Prostate cancer.
  • Bladder cancer.
  • Bladder atonia, neurogenic bladder disorder, or other neurological disorder impacting bladder function as the sole etiology of urinary dysfunction; or urinary obstruction due to causes other than BPH, including urethral stricture.
     

WARNINGS AND PRECAUTIONS

General Warnings and Precautions:

  • The iTind System should only be used by clinicians trained in endo-urological procedures and the management of their complications.
  • The risks of implanting the iTind System in patients with blood coagulation disorders, compromised immune systems, or any other conditions that would compromise healing should be carefully considered against the possible benefits.
  • Do not use the iTind System if the patient has a known allergy to Nickel.
  • While the device is in the body, it is better to avoid planned MRI, in order not to compromise the quality of the image. However, a patient with an implant can be scanned safely in an MR system under the following conditions:
    • Static magnetic field of 1.5 Tesla or 3 Tesla, only;
    • Maximum spatial gradient magnetic field of 4,000 gauss/ cm (40 T/m);
    • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/ kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode.
       

For further information, please refer to the iTind™ System IFU UI-0003 Rev 05 (2020).

 

OER-Elite™ Endoscope Reprocessor

The OER-Elite is intended for use in cleaning and high-level disinfection of heat-sensitive Olympus flexible endoscopes, their reusable accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of both the OER-Elite and Olympus flexible endoscopes, their reusable accessories, and endoscope reprocessor accessories.

WARNING

Risk of Injury to the Patient:

  • Certain endoscopes cannot be reprocessed with this reprocessor. Refer to the provided “List of Compatible Endoscopes/Connecting Tubes <OER-Elite>” to see which endoscopes are compatible. Accessories (e.g., valves) that can be reprocessed with this reprocessor are reusable accessories of endoscopes compatible with this reprocessor. To reprocess accessories, be sure to put them in the washing case. Do not attempt to reprocess an endoscope or its reusable accessories unless both are designated as compatible with the OER-Elite. Do not attempt to reprocess an endoscope or its reusable accessories if either have been modified by a third-party repair company; not only will the reprocessor be unable to function at optimal levels, the safety of the patient and operator may be endangered and the reprocessor and/or the endoscope may be damaged. Without knowledge of the materials used or the final quality of repair being provided by third party repair companies, Olympus is unable to validate the material compatibility or reprocessing efficacy of the recommendations contained within the OER-Elite instruction manual.
  • Do not attempt to reprocess an endoscope that is not designated for use with the reprocessor. Do not reprocess two endoscopes that should not be reprocessed simultaneously with each other. Doing so will prevent the reprocessor from functioning properly and may endanger the safety of the patient and operator. In this case, the durability of the reprocessor and its ancillary equipment cannot be guaranteed.
  • After reprocessing, maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment and environments. If the reprocessed endoscope or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them.
  • After disinfecting the alcohol supply line, always rinse it thoroughly. Otherwise, disinfectant solution may remain on the endoscope following reprocessing and pose a patient safety risk.
  • When the alcohol flush process is stopped due to a reprocessor error, do not use the endoscope, and restart the alcohol flush process from the beginning. Otherwise, alcohol may remain in the endoscope channel and pose a risk to patient safety.
  • Always use a disinfectant that has been validated by Olympus. High-level disinfectants that are not validated by Olympus for use in the OER-Elite may be unsafe and ineffective due to improper dilution, incorrect contact time and temperature, excessive foaming, or inadequate rinsing, and therefore may compromise patient safety. Use of a high-level disinfectant that has not been validated by Olympus may also damage internal OER-Elite components (e.g., seals, valves, etc.) and the endoscopes being reprocessed.
  • When a process is interrupted, be sure to execute it again from the beginning. An endoscope that has not been subjected to a complete, error-free process is not safe for patient use. Otherwise, the endoscope reprocessing may be insufficient.
  • If combinations of equipment other than those shown below and other than the package contents are used, Olympus cannot guarantee that the device will perform as expected. Nor can Olympus guarantee the safety of patients and operators. Nor can the durability of the device be guaranteed when non-designated equipment is used. Any damage resulting from improper equipment combinations will not be serviced or repaired free of charge.
  • Do not disassemble, modify, or attempt to repair this reprocessor or its accessories. Doing so could result in operator or patient injury and/or equipment damage or malfunction.

Risk of Injury to Facility Personnel: 

  • Certain endoscopes cannot be reprocessed with this reprocessor. Refer to the provided “List of Compatible Endoscopes/Connecting Tubes <OER-Elite>” to see which endoscopes are compatible. Accessories (e.g., valves) that can be reprocessed with this reprocessor are reusable accessories of endoscopes compatible with this reprocessor. To reprocess accessories, be sure to put them in the washing case. Do not attempt to reprocess an endoscope or its reusable accessories unless both are designated as compatible with the OER-Elite. Do not attempt to reprocess an endoscope or its reusable accessories if either have been modified by a third-party repair company; not only will the reprocessor be unable to function at optimal levels, the safety of the patient and operator may be endangered and the reprocessor and/or the endoscope may be damaged. Without knowledge of the materials used or the final quality of repair being provided by third party repair companies, Olympus is unable to validate the material compatibility or reprocessing efficacy of the recommendations contained within the OER-Elite instruction manual.
  • Do not attempt to reprocess an endoscope that is not designated for use with the reprocessor. Do not reprocess two endoscopes that should not be reprocessed simultaneously with each other. Doing so will prevent the reprocessor from functioning properly and may endanger the safety of the patient and operator. In this case, the durability of the reprocessor and its ancillary equipment cannot be guaranteed.
  • After reprocessing, maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment and environments. If the reprocessed endoscope or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them.
  • If replacement or adjustment of the lid packing is required, please contact Olympus. Only Olympus-trained personnel are permitted to replace the lid packing or adjust its position. Improper installation or positioning of the lid packing may result in leakage of water, detergent solution, or disinfectant solution. This may result in injury to personnel and/or damage to the reprocessor. 
  • If combinations of equipment other than those shown below and other than the package contents are used, Olympus cannot guarantee that the device will perform as expected. Nor can Olympus guarantee the safety of patients and operators. Nor can the durability of the device be guaranteed when non-designated equipment is used. Any damage resulting from improper equipment combinations will not be serviced or repaired free of charge.
  • Do not disassemble, modify, or attempt to repair this reprocessor or its accessories. Doing so could result in operator or patient injury and/or equipment damage or malfunction.

 

ORBEYE™ Exoscope

WARNING

  • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock.
    • Do not souse or spill a liquid such as water over this instrument. If a liquid is spilt on it, immediately wipe it. Should a liquid penetrate this instrument, immediately stop using it and contact Olympus.
    • Do not prepare, inspect, or use this instrument with wet hands.
  • Never install and operate this instrument in locations where:
    • The concentration of oxygen is high;
    • Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere;
    • Flammable gases are present in the atmosphere;
    • Flammable liquids are near.
    • Otherwise, explosion or a fire may result because this instrument is not explosion-proof.
  • Do not use the equipment for ophthalmic surgery or during procedures in which the illumination may make direct contact with the patient's eye. The strong illumination can injure the retina.
  • Do not use for purposes other than those described in "Indications for use" on page 6 of the ORBEYE™ Exoscope OME-V200 Instruction Manual, as this may result in injury of the patient or operator as well as damage to the equipment.
  • This instrument should be used under the conditions specified in "Environments" on page 271 of the ORBEYE™ Exoscope OME-V200 Instruction Manual. Otherwise, imperilment of safety or failure of equipment may result as well as malfunction.
  • Use a recommended sterilized drape. If this instrument is used with not sterilized drape or without the drape, operator or patient infection may result.
     

CAUTION

  • Do not insert an object through the ventilation grilles of the instrument. Otherwise, equipment damage or electric shock may result.
  • Do not look directly at the light guide terminal of the LED light source or the illumination lens of this instrument while the illumination lamp is lit. Also, do not point the illumination lens to others. Otherwise, an eye injury may result.
  • Do not touch the extremity of the light guide cable after it has been disconnected from this instrument. Otherwise, the high temperature immediately after use may cause burns.
  • For this product, be sure to depress the brake pedal on the base and fix this product on the floor except when moving. Unless it is securely fixed to the floor, this product naturally moves and may cause injuries.
  • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
  • If there is a peculiarity in the feeling of depth (for example, the appearance of the depth sense and the feeling of moving the hand do not match), do not use it. As the feeling of depth in the 3D images also varies depending on the distance from the 3D observation monitor to the operator, check the sense of depth whenever the distance from the monitor changes during the procedure, Otherwise, there is a risk of mistake in treatment.
  • Always confirm that the top/bottom positions, colors, and brightness of the left and right images are identical before use. If there is any difference, there is a potential of failure. As the operation in the failed condition tends to cause fatigue and consequent mistake in treatment, contact Olympus.
     

For further information please refer to the ORBEYE™ Exoscope OME-V200 Instruction Manual (2018).

 

POWERSEAL™ Sealer/Divider

Indications for Use

  • The POWERSEAL Sealer & Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, and oophorectomy.
     
  • The POWERSEAL Sealer & Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. DO NOT use the POWERSEAL devices for these procedures.
     

General Warnings

  • The POWERSEAL device is for single use only. It has not been designed to be reused or re-sterilized. Reusing or re-sterilizing can cause excessive wear and degradation of device performance. Changes in material characteristics, such as corrosion, dulled edges, deformation or splitting, may impact the strength of the device. Reusing and/or re-sterilizing can also cause cross-contamination. These risks may potentially affect patient safety.
     
  • This device is intended for use only with the Olympus electrosurgical generators described in this document. Use of this device with other generators may result in undesired tissue effect, may result in injury to the patient or to the surgical team, or may cause damage to the device or generator.
     
  • DO NOT use the Olympus system unless properly trained to use it in the specific, planned surgical procedure. Use of this system without such training may result in serious, unintended patient injury.
     
  • The safe and effective use of RF energy depends on many factors solely under the control of the operator. There is no substitute for properly trained and vigilant personnel. It is important that the Instructions for Use supplied with this or any other medical equipment be read, understood, and followed.
     
  • DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged.
     
  • Use caution during surgical procedures in which patients exhibit certain types of vascular pathology e.g. atherosclerosis, aneurysmal vessels, etc. For best results, apply the seal to unaffected vasculature.
     
  • When this device is used with an energized endoscope, the leakage current from the device and the endoscope are additive. The patient may be exposed to unexpected levels of leakage current if this device is used with an energized endoscope that is not a Type CF applied part.
     
  • The higher the current flow and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small appendages.
     

For further information please refer to POWERSEAL™ Sealer/Divider IFU - PN0014103_AA.

 

ShockPulse-SE Lithotripsy System

Contraindications

Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition, the doctor in charge must decide whether the planned use is possible or not. For further information please refer to the current medical literature.
 

Warnings and Cautions

This medical device should be operated only by or under the direct supervision of a physician experienced in ultrasonic lithotripsy procedures. The user should be thoroughly familiar with this Instruction for Use Manual and operation of this device prior to use. This product is a precision device; handle it with care. Avoid rough or violent handling, which may cause equipment damage.
 

Electrical Safety and Shock Hazards

  1. A potential shock hazard exists when the instrument enclosure is opened. Do not attempt to make repairs. Please contact Olympus Customer Service if any repairs are required.
  2. Do not adjust electronic circuitry. Contact your local Olympus representative or call Olympus Customer Service.
  3. Never attempt to service the device when it is connected to a power source. Hazardous voltages inside the device may cause severe electrical shock. Disconnect the power cord before servicing.
  4. As a type BF applied part, this instrument must never be applied directly to the heart and must not be used in procedures involving cardiac observation or surgery. Do not use electrically active devices such as electrosurgical units, on the patient during lithotripsy.
  5. The housing of the generator must be properly grounded to ensure safe operation. To reduce the risk of electric shock, be sure to connect the power cord to a properly grounded 3-pin receptacle of the proper rating. Do not use a 3-pin/2-pin adapter. Do not position the generator so that it is difficult to connect and disconnect the power cord.
  6. To minimize the risk of electric shock and generator damage, keep all liquids away from the generator. If liquid is spilled into this product, immediately stop the procedure and contact Olympus. If the power cord gets wet, fully dry it before use. Otherwise the user may receive an electric shock.
     

Fire and Explosion Hazards

  1. When used in an environment containing flammable gases and high oxygen concentrations, be aware of the potential for a flammable event. Take routine cautions to prevent this kind of event. The product is not explosion proof.
  2. This product is provided with cooling fan intake on the back panel and air vents for heat release on the side panels. Do not block the fan intake or the air vents. Allow at least 5 cm of space between generator and any other objects.
     

Health Risks

Potential elevated health risks in patients with the following:

  • Active bleeding disorder.
  • During pregnancy.
  • With an electrical stimulator implanted e.g. pacemaker.
  • Untreated urinary tract infection.

On the basis of the patient's general condition, the doctor in charge must decide whether the planned use is possible or not.
 

For further information please refer to the ShockPulse-SE Lithotripsy System SPL-IFU (2020).

 

SOLTIVE™ SuperPulsed Laser System

Contraindications

  • The use of a laser instrument for an application is at the physician's discretion except in cases where the indication has been contraindicated.
  • Inability to receive endoscopic or laparoscopic treatment
  • Intolerance to anesthesia
  • Resection or excision of large, highly vascularized organs
  • Carcinoma of the prostate
  • Septic peritonitis
  • Intestinal obstruction
  • Septic shock
  • Resection or excision of large, highly vascularized organs
     

Complications

The following is a list of general complications that are related to surgery and within the context of laser surgery. The potential complications encountered in endoscopic laser surgery are the same as those normally encountered in conventional endoscopic surgery. Refer to updated literature for specific procedure related complications.
 

Common Surgical Considerations

  • As with non-laser surgery, the possibility of complications and adverse events, such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis, or infection may occur following treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or laser application.
  • As with any conventional surgery, acute pain may occur immediately following laser therapy and may persist for as long as 48 hours.
  • As with any conventional laparoscopic surgery, the use of gas to insufflate the abdomen may lead to a gas embolus. In the extreme case, death may result from an embolus. The use of carbon dioxide gas for insufflation will minimize patient risk, as it is highly soluble in blood.
  • As with any conventional surgery, discontinue laser treatment immediately if the patient develops any cardiopulmonary problems.
     

Post-operative Considerations

Immediately following laser therapy, the patient may experience fever and leukocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Remnants of destructed tissue may become necrotic or infected. If a question of infection exists, appropriate treatment should be carried out.

  • As with any surgical procedure there is a possibility of infection or scarring. Therefore, appropriate pre and post-surgical care should always be practiced.
  • Patients may experience bleeding at the site of laser therapy. Post treatment hematocrits are recommended to identify this potential complication.
  • Sepsis can result from performing any surgical procedure. If a question of sepsis exists, appropriate evaluations should be made.
  • Perforation may occur as a result of laser treatment. To diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.
     

For further information please refer to the SOLTIVE™ Laser System IFU - PN0015551_AE.

 

ULTRAVISION™ Visual Field Clearing System

ULTRAVISION™ Instructions for Use

Investor Information