Related Manuals for Covidien Valleylab LS10
Summary of Contents for Covidien Valleylab LS10
- Page 1 User’s Guide Valleylab LS10 LS Series Single Channel Vessel Sealing Generator Part Number: 1070614...
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Page 2: Preface
It is intended as a guide for using the Covidien Valleylab LS10, LS Series Single Channel Vessel Sealing Generator only. Additional technical information is available in the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual. -
Page 3: Limited Warranty
This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. -
Page 4: Software License
Customer further acknowledges and agrees that the Software is owned exclusively by COVIDIEN. The Software is licensed to be used on only one computing device or Product, and a valid license must be purchased for each computing device on which the Software is installed. - Page 5 Software. COVIDIEN may, in its sole discretion, undertake to incorporate such changes and distribute the Software so modified to all or any of COVIDIEN's customers. All such error corrections, bug fixes, patches, updates or other modifications provided to COVIDIEN shall be the sole property of COVIDIEN.
- Page 6 (vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN; or (viii) Software that has been subjected to abnormal physical or electrical stress, misuse, negligence or accident by Customer or a third party.
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Page 7: Table Of Contents
Correcting Malfunctions ....... 4-4 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... - Page 8 Software Updates ........5-4 Covidien Technical Service......5-4 Chapter 6.
- Page 9 LigaSure ........6-15 China RoHS Compliance (applies to China only) ... 6-16 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator...
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Page 11: Chapter 1. Introduction
The generator is a bipolar electrosurgical generator with no neutral electrode needed and works with LigaSure instruments as a system. Covidien offers a selection of LigaSure instruments that are fully compatible with this generator. The generator supports only compatible Covidien LigaSure instruments. -
Page 12: Indications For Use
Indications for Use Indications for Use The Valleylab LS10 is an electrosurgical generator containing LigaSure vessel sealing technology. The vessel sealing function is indicated for use in sealing (fusing) vessels up to, and including, 7 mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to, surgical specialties such as urologic, vascular, thoracic, gynecologic, plastic and reconstructive, and colorectal. -
Page 13: Generator Front Panel
Check that compatible LigaSure instrument is in proper working condition and no activation switches are depressed. ⑥ Instrument port - Connect LigaSure instruments when the system status indicator is white. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 14: Generator Back Panel
250V, F8.0A (100-240) ① Volume knob ② Footswitch port ③ Serial label ④ Potential equalization conductor terminal ⑤ AC Fuse ⑥ AC mains receptacle ⑦ ECG blanking connector ⑧ USB port ⑨ Vent Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 15: Ligasure Mode
The LigaSure instruments that complete the Valleylab vessel sealing system include reusable and single-use instruments for open and minimally-invasive procedures. Each reusable instrument requires a corresponding single-use electrode. The LigaSure function is only available when using Covidien LigaSure instruments. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 17: Chapter 2. Patient And Operating Room Safety
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 18: General
Improper connection may result in arcs, sparks, instrument malfunction, or unintended surgical effects. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when the generator is delivering RF energy. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 19: Fire/Explosion Hazard
When using a smoke evacuator in conjunction with the generator, set the system volume control at a level that ensures that the activation tones can be heard. Connect only Covidien approved LS0300 footswitch (purple). Using footswitches from other manufacturers may cause equipment malfunction. -
Page 20: Implanted Electronic Devices (Ieds)
Consult the pacemaker manufacturer or hospital cardiology department for further information when use of vessel sealing technology is planned in patients with cardiac pacemakers. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 21: Inadvertent Radio Frequency (Rf) Burns
LigaSure Warning LigaSure instruments are intended for use only with compatible Covidien generators and energy platforms. See the instrument instructions for use for a list of compatible generators.Use of these instruments with other generators may not result in electrical output for which these instruments were designed and may not result in the desired clinical effect. - Page 22 All compatible Covidien instruments have voltage ratings that are greater than the maximum output voltages in the generator.
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Page 23: Ligasure In Minimally-Invasive Procedures
Ensure that the insulation of single-use and reusable laparoscopic instrumentation is intact and uncompromised. Compromised insulation may lead to inadvertent metal-to-metal sparking and neuromuscular stimulation and/or inadvertent sparking to adjacent tissue. Covidien recommends against the use of laparoscopic surgery on pregnant patients. Warning For laparoscopic procedures, be alert to these potential hazards: •... -
Page 24: After Surgery
Position the generator so it doesn’t block access to the power cord for disconnection. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 25: Chapter 3. System Setup
Chapter 3 System Setup This chapter describes how to set up the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator, turn it on, and configure system settings. Precaution Read all warnings, precautions, and instructions provided with this system before use. -
Page 26: Ligasure Function Overview
The instrument receptacle on this system is designed to accept only one instrument at a time. The system is a single channel LigaSure generator. Precaution Read the instructions, warnings, and precautions provided with LigaSure instruments before use. Specific instructions are not included in this manual. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 27: Footswitch
• A tone sounds upon completion of self-test and system indicator illuminates constant white. 2. If the system does not pass the power-up self-test and an error indicator is displayed, refer to Chapter 4, System Alerts and Troubleshooting section for troubleshooting instructions. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 28: Ligasure Instruments
– If the red light above the receptacle continues to appear, use a new, compatible LigaSure instrument. There are several reasons an instrument can be read as invalid, including: • Not recognized • Not compatible • Handswitch or footswitch is stuck Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 29: Activating The Ligasure Instrument
4. Hold the handswitch or footswitch until the seal cycle complete tone is heard. 5. If possible, reposition the instrument and regrasp tissue in another location. Reactivate the seal cycle. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 30: After Surgery
• If the instrument is a single use only (disposable), dispose of it according to the procedures for your institution. • If the instrument is reusable, clean and sterilize it according to the manufacturer’s instructions for use. 3. Disconnect and store footswitch. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 31: Chapter 4. Troubleshooting
Read all warnings, precautions, and instructions provided with this system before use. Read the instructions, warnings, and precautions provided with LigaSure instruments before use. Specific instructions for LigaSure instruments are not included in this manual. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 32: General Troubleshooting Guidelines
General Troubleshooting Guidelines General Troubleshooting Guidelines If the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator malfunctions, check for obvious conditions that may have caused the problem: • Perform steps outlined in Chapter 4, System Alerts and Troubleshooting section for the specific issue. - Page 33 LigaSure instrument use handswitch functionality to energy delivered activate energy. Amber or red usage limit Inserted device has Replace with certified Covidien indicator illuminated already been used LigaSure instrument. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator...
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Page 34: Service Mode
(stop surgery generator and LigaSure immediately) instrument and cords for damage. Abnormal 50 Hz-60 Hz Contact your biomedical leakage currents engineering department or a Covidien Technical Service representative for assistance. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... - Page 35 Power cycle the generator. Replace the instrument if it continues to malfunction. Internal component Use a backup generator. malfunction Contact your biomedical engineering department or a Covidien Technical Service representative for assistance. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator...
- Page 36 Contact your The generator may respond to biomedical engineering the resulting voltage department or a Covidien differences between grounded Technical Service objects. representative for assistance. Malfunctioning monitor Replace the monitor. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator...
- Page 37 LigaSure system is planned in patients with cardiac pacemakers. Internal Cardiac Defibrillator ICD is activated by generator Stop the procedure and (ICD) activation contact the ICD manufacturer for instructions. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator...
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Page 39: Chapter 5. Maintenance And Repair
Read all warnings, precautions, and instructions provided with this system before use. Read the instructions, warnings, and precautions provided with LigaSure instruments before use. Specific instructions for LigaSure instruments are not included in this manual. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 40: Responsibility Of The Manufacturer
Refer to the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator Service Manual for instructions. -
Page 41: Cleaning
Product Service Covidien recommends that all Valleylab systems be returned to the manufacturer for all service requirements. If any service is required without returning the system to the manufacturer, Covidien recommends that only qualified personnel service the Valleylab system. -
Page 42: Adjustment To Factory Specification (Calibration)
Software Updates Software updates are available directly from Covidien by using the Valleylab Exchange Remote Software System application. Go to www.covidien.com/valleylabexchange to download and install the latest version of the Valleylab Exchange application. For additional information, the Valleylab Exchange Remote Software System User’s Guide is... -
Page 43: Chapter 6. Technical Specifications
Read all warnings, precautions, and instructions provided with this system before use. Read the instructions, warnings, and precautions provided with LigaSure instruments before use. Specific instructions for LigaSure instruments are not included in this manual. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 44: Performance Characteristics
A Covidien cart (UC8009) or a stable, flat surface Dimensions and Weight Width 300 mm (11.81 inches) Depth 377 mm (14.84 inches) Height 105 mm (4.13 inches) Weight 5 Kg (11 lbs) Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 45: Operating Parameters
Internal Battery Battery for RTC Battery type – 3 V lithium button cell Battery life – 5 years Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 46: Audio Volume
Seal cycle complete tone – Two tones played for175 ms each at 985 Hz with a 175 ms break between the tones System error tone – Three 200 ms tones separated by 300 ms for each error/system-alert event Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 47: Usb Port
Normal polarity, ground open: < 50 μA Reverse polarity, ground open: < 50 μA Mains voltage on applied part: < 50 μA Sink current at high < 50 μA line, all inputs Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 48: High Frequency (Rf) Leakage Current (Iec 60601-2-2)
Fuses (2) – 5 mm x 20 mm 8 A, 250 V fast blow, high-breaking capacity fast blow, high-breaking capacity Power plug: Power plug: 3-prong hospital grade connector 3-prong locally approved connector Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 49: Power Cord Specification
Plug - minimum 5 A - 250 VAC Unit receptacle - IEC female, minimum 5 A - 250 VAC Important Contact your local Covidien representative for alternative internationally approved power-cord options. Input Frequency The generator operates within specification at all line-input frequencies between 48 Hz and 62 Hz. -
Page 50: Standards And Iec Classifications
Unit produces non-ionizing radiation Classified with respect to electrical shock, fire, and mechanical hazards only in accordance with UL standard 60601-1; certified to CSA standard C22.2 No. 601.1. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 51: Symbols
Symbols Symbols Catalogue number Consult instructions for use Manufacturer Authorized representative in the European community Date of manufacture Footswitch Alternating current Potential equalization conductor terminal Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... - Page 52 Russian GOST-R ME20 CE mark and notified body number 0123 Volume adjustment for activation tones Equipment should not be disposed in trash. Dispose of this product according to local regulation. 6-10 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator...
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Page 53: Class I Equipment (Iec 60601-1)
AC and an emergency system-voltage source. (IEC 60601- 1:1988 + A1:1991 + A2:1995 clause 49, IEC 60601-1:2005 clause 11.8, IEC 60601-2- 2:2006 clause 51.101, and IEC 60601-2-2:2009 clause 201.11.8) Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-11... -
Page 54: Electromagnetic Compatibility
Ensure adequate separation of electronic medical equipment based on observed reactions. The use of accessories, other than specified in the Valleylab LS10, LS Series Single Channel Vessel Sealing Generator User’s Guide and Service Manual, may result in increased emissions or decreased immunity of the system. - Page 55 Warning RFID function may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements (required by clause 5.2.2.5 b in IEC 60601-1-2:2007). Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-13...
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Page 56: Output Characteristics
LigaSure vessel sealing technology, an automatic adjustment, controls all modes. As tissue resistance increases throughout the seal cycle, the generator modulates current and voltage until tissue resistance meets seal complete requirements as needed by the tissue- sensing technology. 6-14 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... -
Page 57: Output Power Vs. Resistance Graphs
14.5 Nominal power curve for an output power of 270 W at rated load with current/voltage limits per the power curve table. Power curve represents the operational envelope, which varies. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-15... -
Page 58: China Rohs Compliance (Applies To China Only)
(LED Display) 电源模块 (PSU) VIBE 模块 (VIBE Module) 电源线 (Power Cord) 金属部件 (Metal parts) 塑料部件 (Plastic parts) 橡胶部件 (Rubber parts) 电缆组件含 风扇 (Cable assembly including fans) 紧固件 (Fasteners) 泡棉部件 (Foam parts) 6-16 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator... - Page 59 It shall not be regarded as a warranty term or guarantee period. Any device label containing this symbol indicates the device can be recyclable. Please dispose the device according to local rules and regulations. Valleylab LS10, LS Series Single Channel Vessel Sealing Generator 6-17...
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