ALTRUS Operators Manual Rev D Dec 2010

LIMITED WARRANTY For a period of two years following the date of delivery, CONMED Corporation warrants the CONMED Altrus® Thermal Tissue Fusion Energy Source against any defects in material or workmanship and will repair or replace (at CONMED’s option) the same without charge, provided the maintenance as specified in this manual has been performed using replacement parts approved by CONMED. This warranty is void if the product is used in a manner or for purposes other than intended.

STERILE EO © 2010 CONMED Corporation MdSS GmbH EC

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525 French Road Schiffgraben 41 STERILE D-30175 Utica, NY Hannover 13502-5994 USA Germany

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STERILE A

U.S. Patents Pending

For Technical Service or Return Authorization Phone: 303-699-7600 / 1-800-552-0138 Extension 5274 0123 LOT Fax 303-699-1628

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For Customer Service or to order parts phone: 1-800-448-6506 / 315-797-8375 / Fax 315-735-6235 or contact your CONMED Representative. CUT

EC

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COAG

STERILE EO

European Authorized Representative MdSS GmbH Schiffgraben 41 MDSS GmbH STERILE D-30175 Hannover Schiffgraben 41 Germany D-30175 Hannover STERILE Germany

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9083

The revision level of this manual is specified by the ~cover highest revision letter found on either theLOT inside front 0123 or enclosed errata pages (if any).

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Manual Number: 60-9543-ENG Rev. D 12/10 CUT

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Unit Serial Number_________________________________

9083

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Table of Contents & List of Illustrations

Section

1.0

Title

Page

General Information... 1-1

1.1 1.1.1 1.1.2 1.1.3 1.1.4

Cautions...1-1 Cautions for Equipment Preparation...1-2 Cautions For Patient Preparation...1-4 Cautions For Use...1-4 Cautions for Testing or Servicing...1-8

2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.1.4.1 2.1.4.2 2.1.5 2.1.5.1 2.1.5.2 2.2 2.2.1 2.2.2 2.3 2.3.1 2.3.2 2.3.3 2.3.3.1 2.3.3.2 2.3.3.3 2.3.3.4 2.3.3.5 2.3.3.6 2.3.3.7 2.3.3.8 2.3.3.9 2.3.3.10 2.3.3.11 2.3.4 2.3.4.1 2.3.4.2 2.3.4.3 2.3.4.4

Energy Source Unpacking, Inspection, Installation, and Functional Checks...2-1 Initial Energy Source Unpacking and Inspection...2-1 Energy Source Installation...2-1 Energy Source Transport Configuration...2-1 Energy Source Controls, Displays and Connectors...2-2 Energy Source Front Panel...2-2 Rear Panel...2-3 Preliminary Energy Source Checks...2-4 Preliminary Energy Source Functional Testing...2-4 Preliminary Performance Testing ...2-4 Handpiece Unpacking, Inspection, and Features...2-4 Initial Handpiece Unpacking and Inspection...2-4 Handpiece Controls, Displays and Connectors...2-5 Use of the Altrus Thermal Tissue Fusion System...2-6 Set-up for Use...2-6 System Modes...2-7 Altrus Settings...2-9 User Interface Navigation...2-9 Operate Screen...2-9 User Settings Screen Access...2-9 User Settings Screen...2-10 LCD Brightness Adjustment...2-10 Setting Language...2-11 Enable Remote Mode Change...2-11 View Previous Errors...2-12 Activation Log...2-13 Energy Source Tone Loudness Control...2-14 Surgical Mode Settings...2-14 User Interface Display During Operation...2-16 Energy Source Error and Status Indicator...2-16 Handpiece Error and Status Indicator...2-16 Handpiece Type...2-16 System Status Description...2-17

2.0

Installation and Operation... 2-1

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2.3.4.5 2.3.4.6 2.3.4.7 2.3.4.8 2.3.4.9 2.3.4.10

2.4 2.4.1 2.4.2 2.4.3

3.0

3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.2 3.2.1 3.2.2 3.3

4.0

4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.2 4.3 4.3.1 4.3.2 4.3.3 4.3.4

Visual System Status...2-17 User Information Display Indications for Seal...2-17 Display Indications for Cut...2-18 User Information Display Indications for Auto...2-19 Excessive temperature indicator...2-19 Errors on the User Information Display ...2-20 Use in Surgery...2-20 Using Manual Mode...2-20 Using Automatic Mode...2-21 Use with a Footswitch...2-22 Maintenance and Troubleshooting...3-1 User Maintenance...3-1 General Maintenance Information...3-1 Cleaning...3-1 Periodic Inspection...3-1 Periodic Performance Testing...3-1 Internal Power Sources...3-1 Error Indications...3-1 Error Indications...3-2 Assistance...3-4 Environmental Protection...3-4 Specifications and Compliance...4-1 Specifications...4-1 Mains Connection...4-1 Mains Overcurrent Protection...4-1 Mains Frequency Leakage...4-1 Regulatory Compliance...4-1 Operation...4-1 Environmental...4-1 Audio Specifications...4-2 Other Specifications...4-2 Animal and Bench Testing...4-3 Explanation of Symbols...4-4 Electromagnetic Compatibility...4-5 EN/IEC 60601-1-2 Table 201...4-5 EN/IEC 60601-1-2 Table 202...4-6 EN/IEC 60601-1-2 Table 204...4-7 EN/IEC 60601-1-2 Table 206...4-8

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General Information Section 1

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. This Operator’s Manual provides the user with set up and operating instructions for the Altrus® Thermal Tissue Fusion System (Altrus). The Altrus system is to be used by licensed clinicians that have been trained in its use. Please read this Operator’s Manual thoroughly before using the system. Please understand and follow the warnings and cautions that are included in this manual. Technical specifications, performance characteristics and user maintenance instructions are also included in this Operator’s Manual.

Intended Use The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect. Handpiece Shaft Diameter

Max Tissue Diameter

10mm

7mm

5mm

4mm

Note:

The limitation of the vessel size to achieve sealing in arteries and veins is based on the study in the animal model.

The Altrus Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general and gynecological procedures for ligating (sealing) and dividing (cutting) of tissue when hemostasis is desired. Other features of the Altrus system include: •

Utilization of thermal technology to deliver energy

•

Microprocessors in both the Handpiece and energy source provide feedback loop to control the temperature delivered to the tissue

•

Short cycle times to minimize thermal spread

•

Ability to operate the Altrus system in either a Manual or Automatic mode

•

Parallel jaw closure mechanism to promote more consistent seals

•

Bladeless cut function allows for cut of desired vessel or tissue

•

Ability to use the Handpiece in either open or laparoscopic procedures

•

Ergonomically designed to minimize hand fatigue

Device Information This manual applies only to the following devices: Catalog Number

Device Description

60-9500-120

Altrus Energy Source

60-9510-001

Altrus Handpiece, 10mm x 16cm

60-9511-001

Altrus Handpiece, 10mm x 23cm

60-9512-001

Altrus Handpiece, 10mm x 36cm

60-9520-001

Altrus Handpiece, 5mm x 16cm

60-9521-001

Altrus Handpiece, 5mm x 23cm

60-9522-001

Altrus Handpiece, 5mm x 36cm

1.1

Cautions

This equipment, in conjunction with connected accessories, is intended to produce high-temperature thermal energy for the controlled fusion of tissue. Altrus is a system with a single-use Handpiece that is used to apply the thermal energy and pressure to the tissue being fused and a multiple-use Energy Source that provides the energy for generating and controlling the thermal energy. Safe and effective surgical tissue fusion is dependent not only on equipment, but also on factors under the control of the operator. It is important that the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment. Altrus is capable of causing physiological effects, including burns to the patient or operator. Only properly qualified and trained clinicians should

1-1

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perform tissue fusion. The operator and their support personnel must be diligent in assuring that Altrus is properly configured and that proper settings are used. Altrus must be in a location that assures the operator or their support personnel can readily verify the settings. PLEASE NOTE: Federal law (U.S.A.) requires that all health care facilities must report to the manufacturer of a medical device, any death or serious injury or illness to a patient related to the use of a medical device. Serious injuries or illness involving the use of a medical device must be reported to the manufacturer of the device (or to the FDA if the manufacturer of the device is not known) within 10 working days of the incident. Summary reports of such injuries must also be submitted directly to the FDA twice a year. Patient deaths related to the use of a medical device must be reported to the manufacturer and the FDA. For further information, please contact the Regulatory Affairs Department of CONMED Electrosurgery at 800-552-0138, 303-699-7600 or FAX 303-6999854.

1.1.1 Cautions for Equipment Preparation WARNING: USE ONLY CONMED ALTRUS ENERGY SOURCES. USE OF ALTRUS HANDPIECES WITH OTHER CONMED GENERATORS OR WITH GENERATORS PRODUCED BY OTHER MANUFACTURERS COULD RESULT IN DAMAGE TO THE HANDPIECES OR INJURY TO THE PATIENT OR SURGICAL TEAM. USE ONLY CONMED ALTRUS HANDPIECES. USE OF OTHER HANDPIECES MAY RESULT IN UNKNOWN AND POTENTIALLY HAZARDOUS CONDITIONS. HANDPIECES ARE INTENDED ONLY FOR SINGLE-USE. DO NOT REUSE HANDPIECES. THE HANDPIECE WAS NOT DESIGNED FOR RE-STERILIZATION AND ATTEMPTS AT RE-STERILIZATION WILL NOT BE EFFECTIVE AND MAY DAMAGE THE HANDPIECE. USE ONLY CONMED ELECTROSURGERY FOOTSWITCHES. OTHER MANUFACTURER’S FOOTSWITCHES MAY NOT BE COMPATIBLE AND CAUSE UNEXPECTED BEHAVIOR.

Caution:

1-2

•

Accessory equipment connected to the analog and digital interfaces must be certified to the respective nationally harmonized IEC standards (i.e. IEC 60950 for data processing equipment, IEC 60065 for video equipment, IEC 61010-1 for laboratory equipment, and IEC 60601-1 for medical equipment.) Furthermore all configurations shall comply with the system standard IEC 606011-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical services department or your local representative.

•

To reduce the risk of electrical shock and abnormal operation, Equipment connected to the Energy Source Operating Room Control

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Centers (ORCC) Serial Interface Connector must be approved by CONMED and must be connected in accordance with instructions accompanying the equipment. Verify proper operation prior to Altrus use. •

Visually inspect Handpiece and packaging for damage prior to use. Do not use if Handpiece or packaging is damaged.

•

Handle jaws carefully. Rough handling can result in bent or broken jaws.

•

Damaged Handpieces or cords may result in injury or electrical shock to the patient or surgical team.

•

In order to ensure proper performance, if either the Handpiece or Energy Source have been stored at a temperature outside the operating conditions specified in section 4.1.6, prior to use allow time for temperature equilibration before using.

•

While Altrus has been tested and certified for compliance with recognized standards, some other electronic equipment in the operating room may be sensitive to Electro-Magnetic Interference (EMI) from Altrus, and function of such equipment may be damaged or impaired. Adverse effects can only be mitigated by use of equipment specifically designed to tolerate interference within recognized limits.

•

Other equipment in the operating room, including portable or mobile communications equipment, may produce EMI, which can affect the function of Altrus. Adverse effects can only be mitigated by use of equipment with EMI characteristics proven within recognized limits. In the event of suspected interference from other equipment, discontinue use of Altrus until the problem can be remedied.

•

•

To avoid risk of falling objects, do not stack other devices or equipment on top of or adjacent to the Altrus Energy Source. The CONMED Stacking Adapter (Cat. No. 60-9541-001) allows one Altrus Energy Source to be stacked on top of the CONMED System 5000 electrosurgical generator in a safe manner. Exercise care when transporting the Energy Source mounted individually or with other devices on a cart to prevent tipping, which may result in injury from falling objects.

•

To avoid potential tipping of the Altrus Energy Source when mounted to a System 5000 transport cart, items placed in the upper accessory basket should be limited to disposable accessories (i.e., electrosurgical pads and pencils). To avoid damage to the cart, do not exceed the basket weight limit of 7.5 lbs.

•

To avoid potential failures from ingress of fluids, do not place liquid containers on top of the Altrus Energy Source. Wipe spilled liquids off the Altrus Energy Source immediately. To preclude inadvertent entry of liquids, do not operate the Altrus Energy Source except in its normal position. WARNING:

TO MINIMIZE THE RISK OF ELECTRICAL SHOCK, USE ONLY A HOSPITAL GRADE POWER CORD RATED TO MEET THE SPECIFICATIONS IN SECTION 1.2 AND ALL OF THE REQUIREMENTS FOR SAFE GROUNDING OF THE ENERGY SOURCE. THE USER SHOULD VERIFY THE POWER RECEPTACLE WITH WHICH THIS ENERGY SOURCE IS USED IS PROPERLY GROUNDED, CORRECTLY POLARIZED AND OF THE PROPER FREQUENCY PER SECTION 4.1. DO NOT USE GROUND “CHEATER PLUGS” OR EXTENSION CORDS. WARNING: THE ALTRUS SYSTEM SHOULD ONLY BE USED IN AN OPERATING ROOM THAT MEETS THE ENVIRONMENTAL REQUIREMENTS AS LISTED IN SECTION 4.1.6 AND ELECTROMAGNETIC COMPATIBILITY AS LISTED IN SECTION 4.3

Caution: •

To avoid tripping, place the Cord away from areas of high activity.

•

Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team to when the system is either sealing or cutting, when a cycle is completed, or when a cycle was potentially unsuccessful.

•

Altrus runs a series of power-on self diagnostics to confirm correct function. If these diagnostics result in an error or an active indica-

1-3

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tion of Test Mode, as described in Section 2.3.2 System Modes, replace the Energy Source or Handpiece. Contact a Hospital Qualified Biomedical Technician for assistance. •

The Handpiece will not activate once it exceeds its 200 maximum activation count.

•

Do not pull on cords to move the Energy Source or Handpiece as damage to the insulation and increased risk injury may result.

1.1.2 •

environment, as there is a risk of igniting these materials if a spark should occur. •

Cautions For Patient Preparation

The risk of igniting flammable gases or other materials cannot be eliminated by device design. Precautions must be taken to restrict flammable materials and substances from the surgical site. Flammable materials may be present in the form of an anesthetic, life support, skin preparation agents, natural gasses within body cavities or in surgical drapes, tracheal tubes or other materials. There is a risk of pooling of flammable solutions in body depressions such as the umbilicus and in body cavities, such as the vagina. Any fluid pooled in these areas should be removed before Altrus is used. Due to the danger of ignition of endogenous gases, the bowel should be purged and filled with nonflammable gas prior to abdominal surgery.

WARNING: VERIFY THAT ALL ANESTHESIA CIRCUIT CONNECTIONS ARE LEAKFREE BEFORE AND DURING USE OF ALTRUS. FACIAL AND OTHER BODY HAIR IS FLAMMABLE. WATER SOLUBILE AND SURGICAL LUBRICATING JELLY MAY BE USED TO COVER HAIR CLOSE TO THE SURGICAL SITE TO DECREASE FLAMMABILITY.

WARNING: ALTRUS SHOULD NEVER BE USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS, FLAMMABLE PREP SOLUTIONS, FLAMMABLE DRAPES, OXIDIZING GASES SUCH AS NITROUS OXIDE (N2O), OR IN OXYGENENRICHED ENVIRONMENTS. ONLY NON-FLAMMABLE AGENTS SHOULD BE USED FOR CLEANING AND DISINFECTION OF THE ENERGY SOURCE.

Caution: •

Exercise care when moving the Altrus Energy Source to avoid electrostatic charge buildup in the presence of flammable materials, as there is a risk of igniting these materials if a spark should occur.

•

The Altrus mobile pedestal is made of nonconductive plastic that can hold a static charge. It should not be used in a flammable

1-4

The use of Altrus on patients with cardiac pacemakers, Automated Implantable Cardioverter-Defibrillators (AICDs), neurostimulators or other active implants is potentially hazardous. The implant may be irreparably damaged and/or the high frequency energy of Altrus may interfere with the function of the implant. Ventricular fibrillation may occur. Precautions should be taken to ensure the patient’s well-being is maintained in the event of such interaction. The manufacturers of the implants should be consulted for advice before operating on a patient with an implant. These precautions also apply to operating room personnel with similar implants.

Caution: •

Studies have shown that smoke generated during energy-assisted surgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke.

1.1.3

Cautions For Use WARNING:

DO NOT USE ELECTROSURGICAL EQUIPMENT IN CONJUNCTION WITH ALTRUS UNLESS PROPERLY TRAINED TO USE IT IN THE SPECIFIC PROCEDURE BEING PERFORMED. USE OF THIS EQUIPMENT WITHOUT SUCH TRAINING CAN RESULT IN SERIOUS UNINTENDED PATIENT INJURY.

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Caution: •

WARNING:

For the safety of the patient and operating room staff, observe all caution and warning symbols. WARNING: USE THE HANDPIECE ONLY FOR THE PURPOSES DESCRIBED IN THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE HANDPIECE. USE FOR OTHER PURPOSES MAY NOT BE SUCCESSFUL AND LEAVE LATENT INJURIES THAT MAY NOT BE IMMEDIATELY APPARENT. WARNING:

ONLY CERTAIN TISSUE TYPES ARE APPROPRIATE FOR SEALING AND CUTTING USING ALTRUS. DO NOT ATTEMPT TO SEAL OR CUT CALCIFIED VESSELS OR TISSUE. USE CAUTION DURING SURGICAL CASE IN WHICH PATIENTS EXHIBIT CERTAIN TYPES OF VASCULAR PATHOLOGY (ATHEROSCLEROSIS, ANEURYSMAL VESSELS, ETC.) THERE IS NO ANIMAL MODEL PREDICTIVE OF HOW THE DEVICE FUNCTIONS WHEN USED TO SEAL VESSELS CONTAINING ATHEROSCLEROTIC PLAQUE. FOR BEST RESULTS APPLY THE SEAL TO THE UNAFFECTED VASCULATURE. TO AVOID THE RISK OF FIBRILLATION FROM ELECTRICAL SHOCK IN THE EVENT OF A FAILURE, DO NOT USE ALTRUS IN DIRECT CONTACT WITH THE HEART.

Caution: •

To ensure seals are complete and effective, do not attempt to seal or cut vessels or tissue larger than that specified for a particular Handpiece model.

•

Sealing previously sealed tissue in the same location is not recommended and may reduce seal effectiveness. Cutting in the location of previously multiply sealed tissue may not be effective.

LAPAROSCOPIC SURGERY MAY RESULT IN GAS EMBOLISM FROM INSUFFLATIONS OF GAS IN THE ABDOMEN. CONMED RECOMMENDS AGAINST THE USE OF LAPAROSCOPIC SURGERY ON PREGNANT PATIENTS. THE ALTRUS TISSUE SEALING FUNCTION HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR STERILIZATION PROCEDURES. DO NOT USE ALTRUS FOR THESE PROCEDURES.

Caution: •

Since the clinical use of tissue fusion is intermittent in nature with low duty cycles, Altrus was not designed to be activated repetitively without pause. The Energy Source duty cycles must be limited to no more than 10 activation cycles within 60 seconds followed by a 30 second inactive period. Handpiece duty cycle limits vary by the type of Handpiece and are stated in the instructions accompanying each Handpiece. The Energy Source will automatically limit repetitive activations and will indicate when this limitation is being imposed.

•

Apparent low power output or failure of Altrus to provide the expected effect at otherwise normal settings may indicate faulty application, the failure of a Handpiece, or excessive accumulation of tissue on the Handpiece heating surface. If this should occur, check for errors, examine the jaws for debris, wipe with gauze moistened in saline if necessary, and retry. WARNING:

DO NOT CONNECT WET INSTRUMENTS TO THE ENERGY SOURCE. ENSURE THAT ALL INSTRUMENTS AND ADAPTERS ARE CORRECTLY CONNECTED AND THAT NO METAL IS EXPOSED AT ANY CONNECTION POINTS.

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the Handpiece with the jaws closed on nontissue material.

WARNING: THE JAWS OF A RECENTLY ACTIVATED HANDPIECE MAY BE HOT ENOUGH TO BURN THE PATIENT OR CLINICIAN, CAUSE THERMAL DAMAGE TO ADJACENT TISSUE, OR IGNITE SURGICAL DRAPES OR OTHER FLAMMABLE MATERIALS. ENSURE HANDPIECE JAWS ARE NOT IN CONTACT WITH UNINTENDED TISSUE, SURFACES, OR OBJECTS UNTIL THEY HAVE COOLED SUFFICIENTLY. DO NOT GRASP DRAPES OR OTHER FLAMMABLE MATERIALS WHILE HANDPIECE JAWS ARE HOT OR ACTIVATED. THE ENERGY SOURCE WILL AUTOMATICALLY LIMIT ACTIVATION WHILE HANDPIECE JAW TEMPERATURE IS IN EXCESS OF PROPER FUNCTIONING PARAMETERS AND WILL INDICATE WHEN THIS LIMITATION IS BEING IMPOSED.

Caution: •

Use care when closing the Handpiece Lever to avoid pinching hand or perforating a glove.

•

Avoid breathing the vapors emitted during the use of this device as they may cause health hazards. Use of devices for evacuating and filtering smoke and other vapors is recommended.

•

When not in use, Handpieces should be stowed to ensure that they are not damaged by dropping or impact with other objects and to ensure that the jaws do not come in contact with unintended surfaces. Unused Handpieces should never be placed on the patient.

•

Use only gauze lightly moistened with saline solution to wipe debris from the jaws.

•

The polished surfaces of the jaws are crucial to minimizing tissue sticking. During use, inspect the jaws periodically for damage or irregularity. Since jaw surfaces could be damaged, do not compress hard non-tissue materials between the jaws.

•

1-6

Activating a Handpiece with the jaws closed on non-tissue material will compromise seal effectiveness and the material may decompose leaving a residue of material on the jaws that may not be bio-compatible. Do not activate

•

Do not expose the jaws to any solvents or cleaning solutions as jaw damage may result.

•

Do not apply the excessive lateral or radial forces to the Handpiece jaws as damage to the jaws may result and compromise sealing or cutting performance.

•

Do not contact any other surgical instruments with the jaws, as jaw damage may occur or the heat may be drawn away from the jaws, resulting in an ineffective seal.

•

The Handpiece body is not designed to be submersed or subjected to excessive amounts of liquid, and such exposure may affect proper Handpiece function, resulting in ineffective seal or cut functions. Avoid spilling liquids on the Handpiece body. Do not soak or immerse the body of the Handpiece in any liquid. WARNING:

DO NOT APPLY ELECTROSURGICAL ENERGY DIRECTLY TO ANY PART OF THE HANDPIECE, SHAFT OR JAWS SINCE IT MAY DAMAGE THE HANDPIECE OR THE ENERGY SOURCE. INADVERTENT ACTIVATION OR MOVEMENT OF THE ACTIVATED ALTRUS HANDPIECE OUTSIDE THE FIELD OF VISION MAY RESULT IN INJURY TO THE PATIENT.

Caution: •

Carefully insert and withdraw the Altrus Handpiece from cannulas to avoid possible damage to the device and/or injury to the patient.

•

Do not ignore unexpected tones. Check the Display to determine the cause of the tone, unexpected activation can cause injury.

•

Use caution when selecting the seal footswitch for seal and the cut footswitch for cut.

•

Ensure that the footswitches are not inadvertently depressed in order to prevent the Handpiece from being unintentionally activated. Place footswitches in locations that necessitate deliberate action in order to activate the footswitch.

•

Confirm the desired Surgical Mode is selected prior to use to ensure output characteristics are suitable for the intended procedure.

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WARNING: OPENING THE JAWS DURING A CYCLE WILL TERMINATE THE HEATING CYCLE AND CAN RESULT IN AN INCOMPLETE SEAL OR CUT.

WARNING: ONLY TISSUE FIRMLY GRASPED BETWEEN THE JAWS WILL BE SEALED, TISSUE MUST BE COMPLETELY WITHIN THE JAWS BEFORE INITIATING A SEAL OR CUT CYCLE. DO NOT ALLOW THE TISSUE TO MOVE OUT OF THE JAWS DURING A SEAL OR CUT CYCLE. DO NOT ACTIVATE ALTRUS UNTIL THE HANDPIECE HAS BEEN CLOSED AROUND THE VESSEL WITH THE PROPER PRESSURE APPLIED. ACTIVATING THE SYSTEM BEFORE THIS IS DONE WILL RESULT IN AN IMPROPER SEAL OR CUT AND MAY INCREASE THERMAL SPREAD TO TISSUE OUTSIDE THE INTENDED LOCATION.

WARNING: ACCESSORY EQUIPMENT CONNECTED TO THE ANALOG AND DIGITAL INTERFACES MUST BE CERTIFIED TO THE RESPECTIVE NATIONALLY HARMONIZED IEC STANDARDS (I.E. IEC 60950 FOR DATA PROCESSING EQUIPMENT, IEC 60065 FOR VIDEO EQUIPMENT, IEC 61010-1 FOR LABORATORY EQUIPMENT, AND IEC 60601-1 FOR MEDICAL EQUIPMENT.) FURTHERMORE ALL CONFIGURATIONS SHALL COMPLY WITH THE SYSTEM STANDARD IEC 60601-1-1. EVERYBODY WHO CONNECTS ADDITIONAL EQUIPMENT TO THE SIGNAL INPUT PART OR SIGNAL OUTPUT PART CONFIGURES A MEDICAL SYSTEM, AND IS THEREFORE, RESPONSIBLE THAT THE SYSTEM COMPLIES WITH THE REQUIREMENTS OF THE SYSTEM STANDARD IEC 60601-1-1. IF IN DOUBT, CONSULT THE TECHNICAL SERVICES DEPARTMENT OR YOUR LOCAL REPRESENTATIVE.

WARNING: WHILE A VIABLE SEAL WITH ADEQUATE HEMOSTASIS IS ACHIEVED, PERFORMING A SEAL CYCLE ON SKELETONIZED VESSELS MAY RESULT IN AN UNINTENTIONAL DIVISION OF THE VESSEL.

Caution: •

For effective seals, only attempt to seal or cut vessels when the jaws are perpendicular to the vessel.

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1.1.4

Cautions for Testing or Servicing

Caution: •

The Altrus Energy Source top cover should only be removed by a Hospital Qualified Biomedical Technician as internal voltages are potentially dangerous and there are no userserviceable components inside.

•

The Altrus Energy Source should only be activated in its normal operating position with its feet on a horizontal surface to ensure adequate heat dissipation capability. WARNING:

ELECTRICAL SHOCK HAZARD: ALWAYS TURN OFF AND UNPLUG THE ENERGY SOURCE PRIOR TO CLEANING.

Caution: •

To ensure proper operation, service should only be attempted by a Hospital Qualified Biomedical Technician in accordance with the Altrus Service Manual (Catalog Number 60-9544-ENG).

•

Altrus should be tested by a Hospital Qualified Biomedical Technician on a periodic basis to ensure proper and safe operation. It is recommended that examination of Altrus be performed annually.

•

Altrus has no user-serviceable parts. Refer all servicing to a Hospital Qualified Biomedical Technician. Your CONMED representative will be happy to assist you in getting your equipment serviced.

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® Installation and Operation Section 2

This section contains initial installation, preliminary checks and operating instructions for the Altrus Energy Source and Handpiece.

2.1 Energy Source Unpacking, Inspection, Installation, and Functional Checks 2.1.1 Initial Energy Source Unpacking and Inspection Unpack the Altrus Energy Source upon receipt and physically inspect it for any obvious damage that may have occurred during shipment. A Hospital Qualified Biomedical Technician should perform this inspection. Notify the carrier and your CONMED representative immediately if damage is found.

2.1.2

Energy Source Installation

The Altrus Energy Source may be mounted: •

On the matching mobile pedestal supplied by CONMED (60-9540-001),

•

Atop a System 5000™ electrosurgical generator by using a Altrus – System 5000 stacking adapter (60-9451-001),

•

On an existing adapted System 5000 mobile pedestal using a Mobile Pedestal conversion kit (60-9452-001), or

•

Any cart or table that is both level and flat.

CONMED mobile pedestals and adapters provide features to properly secure the Altrus Energy Source.

wall, allow a two-inch clearance around and above the Altrus Energy Source to permit free circulation of air along the sides of the Altrus Energy Source. Locate the Energy Source to allow the surgeon to view the display, typically at a distance of 1-3 meters, and to allow the circulating nurse to adjust Energy Source settings and respond to alarms, typically at a distance of 0-4 meters.

2.1.3 Energy Source Transport Configuration When mounted on the ConMed mobile pedestal or any other moveable cart, the Energy Source should only be moved when properly configured for transport. This includes: •

The Energy Source is properly secured on the mobile pedestal or cart,

•

All objects are removed from the top of the Energy Source,

•

All cords, footswitches, and other connected or attached accessories are stowed below the Energy Source in a centered location that is near to the base of the mobile pedestal or cart as possible,

Use the handle at the rear of the Energy Source to push the Altrus Energy Source on a mobile pedestal or cart forward. Take care to cross thresholds and other obstructions by only moving the Energy Source forward in this manner. Do not cross thresholds and other obstructions with the cart facing sideways to the obstruction.

WARNING: THE ALTRUS ENERGY SOURCE MUST BE PROPERLY SECURED WHEN MOUNTED ON ANY MOVEABLE CART SO THAT IT WILL NOT FALL AND CAUSE INJURY.

Caution: •

Since the Altrus Energy Source depends on natural convection for cooling, it should not be installed in a cabinet or similar enclosure. If mounted on a shelf or otherwise near a

2-1

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2.1.4

Energy Source Controls, Displays and Connectors

The numbers in the following paragraphs correspond to the numbered items in Figures 2.1 and 2.2.

2.1.4.1 Energy Source Front Panel All controls are located on the front panel. Figure 2.1 illustrates the front panel.

1. Control panel buttons

3. Handpiece Receptacle

2. User Information Display

4. Power Switch

Figure 2.1 Altrus front panel 1. CONTROL PANEL BUTTONS provide a method for interacting with the user interface to display and adjust the Energy Source settings. 2. USER INFORMATION DISPLAY allows settings and other information to be displayed. 3. HANDPIECE RECEPTACLE provides the connection for the Handpiece. Only Handpieces supplied by CONMED may be connected to this receptacle. 4. POWER SWITCH for turning Altrus on and off.

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2.1.4.2 Rear Panel The rear panel contains the footswitch connector, power cord connector, fuses, and a carrying handle. Refer to Figure 2.2. 14. Nameplate

11. Speaker

9. Equipotential Ground Connection

6. Mains Fuses 5. Carrying Handle MAX OPERATION: 10 CYCLES WITHIN 60 SEC FOLLOWED BY 30 SEC INACTIVE

7. ORCC Serial Interface Connector

10. Power and Fuse Ratings Label ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE

IPX1

100-240V~, 10A, 50/60Hz

ORCC

USB

IOIOI

IOIOI

13. Footswitch Connector

REPLACE FUSES AS MARKED.

8. Power Inlet

12. USB Upgrade Connector

Figure 2.2 Altrus rear panel 5. CARRYING HANDLE. 6. MAINS FUSES. 7. ORCC SERIAL INTERFACE CONNECTOR: This connector provides a means of connection with ORCC.

Caution: •

Only equipment approved by CONMED should be connected to this interface. Contact your CONMED representative or CONMED Customer Service at the numbers listed on the inside front cover of this manual for assistance in choosing approved equipment.

8. POWER INLET: Supplies AC mains power to the ENERGY SOURCE. It should only be connected to a source of power corresponding to that listed on the power and fuse ratings label. 9. EQUIPOTENTIAL GROUND CONNECTION: Chassis ground connection suitable for attachment of standard auxiliary grounding cable when required for additional protection against low frequency risk current. 10. POWER AND FUSE RATINGS LABEL: Specifies nominal line voltages, frequency, current and fuse rating information. 11. SPEAKER: Sound from the speaker emanates from this location. 12. USB UPGRADE RECEPTACLE: This connector provides a means for upgrading software in the Energy Source. Upgrades should only be carried out by a Hospital Qualified Biomedical Technician or a CONMED technical representative. Only CONMED provided devices should be connected to this receptacle. 13. FOOTSWITCH CONNECTOR: A 4-pin threaded connector is designed to accept any dual-treadle monopolar footswitch available from CONMED Electrosurgery. Use only CONMED Electrosurgery footswitches. Other manufacturer’s footswitches may not be compatible. 14. NAMEPLATE: Specifies model number and serial number

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2.1.5 Preliminary Energy Source Checks 2.1.5.1 Preliminary Energy Source Functional Testing Performing an Energy Source power-up sequence, as described in steps 1 - 5 of Section 2.3.1, is recommended upon initial installation to avoid unnecessary delays in surgery. See Figures 2.1 and 2.2 for location of controls and connectors.

2.1.5.2 Preliminary Performance Testing After Altrus passes the Preliminary Functional Tests of Section 2.1.5.1, preliminary performance testing may be conducted by a Hospital Qualified Biomedical Technician using techniques described in the CONMED Altrus Service Manual (Catalog Number 60-2454-ENG). Results of testing should be compared to the results tabulated on the factory Test Data Sheet supplied with each Energy Source. This data should be retained for future reference and comparison.

2.2 Handpiece Unpacking, Inspection, and Features 2.2.1 Initial Handpiece Unpacking and Inspection Handpieces are packed in individual packages to maintain sterility with several Handpiece packages in a box. When unpacking a box of Handpieces, physically inspect the box and enclosed Handpiece packages for any obvious damage that may have occurred during shipment. Notify the carrier and your CONMED representative immediately if damage is found.

Caution: •

Do not use Handpiece if damage is suspected.

The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device.

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2.2.2

Handpiece Controls, Displays and Connectors

18. Shaft

15. Cut Button (Both sides)

19. Heater Jaws

20. Shaft Rotator Knob

16.Mode Indicator

21. Seal Button 22. Closure Lever 17. Handle

23. Handpiece Cable and Connector Figure 2.3 Altrus Handpiece 15. CUT BUTTON: Initiates a cut activation cycle when in Manual mode. 16. MODE INDICATOR: Illuminates blue to indicate Manual mode or orange to indicate Automatic mode. 17. HANDLE: Provides an ergonomic grip for positioning and directing the Handpiece 18. SHAFT 19. HEATER JAWS: Compress the vessel or tissue bundle of interest and apply heat for sealing or cutting. 20. SHAFT ROTATOR KNOB: To rotate the shaft and jaws to the desired orientation. 21. SEAL BUTTON: Initiates a seal activation cycle when in Manual mode or initiates a seal-cut cycle when in Automatic mode. 22. CLOSURE LEVER: Use to close the Heater Jaws on a vessel or tissue bundle. 23. HANDPIECE CABLE AND CONNECTOR

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2.3 Use of the Altrus Thermal Tissue Fusion System The basic set-up and operation of the Altrus Thermal Tissue Fusion system for clinical use is described in this section.

2.3.1

Set-up for Use

1. Place equipment on a flat, stable surface. The Altrus Energy source can also be attached its own cart (60-9540-001), installed on an existing System 5000™ cart using the adapter kit (609542-001) or stacked on top of a System 5000 Electrosurgery Generator using the stacking adapter (60-9541-001). 2. tion.

4. Set the Power Switch to the ON (“|”) position. Allow the Altrus Energy Source to go through its internal diagnostics. As the Energy Source executes power-on self-diagnostics, confirm the following: a) A “Seal ON” tone followed by a “Cut ON” tone is sounded. b) After the display test, Altrus will show the software revision and current time. Altrus is conducting a power-on self-test during this interval. If the time setting is incorrect, then contact a Hospital Qualified Biomedical Technician to set the correct time.

Ensure power switch is in the OFF posi-

4. Power Switch

Connect the power cable to a properly grounded and polarized mating power receptacle. 3. If using a footswitch to activate the Handpiece functions, connect a CONMED dualtreadle footswitch to its mating connector at the rear of the ENERGY SOURCE. Use only CONMED Electrosurgery footswitches. Although other footswitch types may connect, they may not be functionally compatible.

c) After Energy Source diagnostics are successfully complete, the User Information display will change to request the user plug the Handpiece connector into the Energy Source Handpiece Receptacle. When first turned on, the Altrus System will always power-up in the Manual mode.

MAX OPERATION: 10 CYCLES WITHIN 60 SEC FOLLOWED BY 30 SEC INACTIVE

ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE

IPX1

100-240V~, 10A, 50/60Hz

ORCC

USB

IOIOI

IOIOI REPLACE FUSES AS MARKED.

13. Footswitch Connector

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5. Select each of the modes by pressing the Control Panel Buttons adjacent to the Mode Indicator Symbols and note the change in Mode

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Indicator Symbols.

these diagnostics the connected Energy Source will indicate a ‘Standby’ condition and the Handpiece Mode Indicator should be illuminated. If diagnostic failures occur, then the Energy Source will so indicate, and the Handpiece may need to be replaced.

Automatic Mode selected – Seal is followed immediately by a cut

Manual Mode selected – Seal and Cut are independently controlled 9. 6. Unpack the Altrus Handpiece while maintaining sterility in accordance with hospital practices and procedures and physically inspect the Handpiece for any obvious damage. Do not use the Handpiece if damage is suspected. 7. Pass the Handpiece Connector across the boundary of the sterile field while maintaining sterility of the Handpiece in accordance with hospital practices and procedures. Connect the Handpiece Connector to the Handpiece Receptacle of an Energy Source that has already been turned on and checked for proper function. To avoid damage to the Handpiece Jaws, place the Handpiece in a location within the sterile field where it is not subject to dropping or damage.

The Altrus System is now ready for use.

2.3.2

System Modes

There are two System Modes associated with the Altrus Energy Source: •

Run Mode is for use during surgery and is the default system mode

•

Test Mode is for maintenance purposes only, and should only be used by Hospital Qualified Biomedical Technicians WARNING: DO NOT USE THE ALTRUS SYSTEM FOR CLINICAL PURPOSES WHILE IN TEST MODE AS SOME SAFETY FEATURES WILL BE DISABLED.

3. Handpiece Receptacle

8. After the Handpiece has been connected, it will undergo a series of self diagnostics to ensure proper function. Upon successful completion of

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There are two indications that the Altrus Energy Source is in Test Mode: 1. When the system is turned on, a message will request confirmation of Test Mode entry. If this should appear, press the Control Panel Button adjacent to “No”.

2. The Operate Screen will appear with a message prohibiting clinical use.

The system mode can only be changed at power up; power must be cycled to change the system mode.

Caution: •

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When either of these screens appear, the Altrus system should not be used clinically. Contact a Hospital Qualified Biomedical Technician or CONMED for assistance in returning the Energy Source for clinical service.