Instructions for Use
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ENGLISH
UPS
Electrical Requirements
UNIVERSAL POWER SUPPLY REF
Input: 100-240 VAC, 50/60 Hz, 80W Maximum Output: 32W No Load Voltage: 6V D.C.
Compliance with Standards
200-004R
UPS
The UPS (Universal Power Supply) complies with IEC60601-1 (UL 2601-1 and CAN/CSA-C22.2 No. 601.1M90) requirements for type Class I, Type CF equipment, Type CF applied parts, and meets electromagnetic compatibility requirements of IEC60601-1-2.
UNIV POW ERSAL SUPP ER LY
Limited Warranty Starion Instruments Corporation warrants that the UPS (Universal Power Supply) will be free from defects in materials and workmanship for a period of one (1) year from shipment invoice provided that the product is used in accordance with applicable instructions. Products found to be defective during this period will be replaced at no charge. Starion Instruments Corporation makes no other warranties with respect to the product and expressly disclaims all other warranties expressed or implied, as to merchantability, fitness for any particular purpose or any other matter. In no event shall Starion Instruments Corporation be liable for consequential damages.
INSTRUCTIONS FOR USE For use only with: Starion Cautery Instruments and Starion PowerPack™ Footswitch
Device Description The UPS (Universal Power Supply) is a non-sterile, reusable, AC powered unit intended to be used only with Starion Cautery Instruments and PowerPack Footswitch. The UPS (Universal Power Supply) is intended to be connected to AC power via a grounded hospital grade power cord and features an on/off switch and green power-on LED indicator. Depending on the device used, up to three operating heat ranges are available. There are 3 heat ranges available from the UPS (Universal Power Supply) with corresponding tones indicating the power level of the instruments heating element. A low frequency tone indicates the use of low heat. An interrupted low tone indicates the use of variable heat, and a higher frequency tone indicates the use of high heat levels. If the user chooses not to install and use the PowerPack Footswitch, the UPS (Universal Power Supply) will supply power at the variable heat level only. The UPS (Universal Power Supply) may be placed on a flat nonsterile surface adjacent to the sterile field, or may be suspended from a nearby IV pole.
EC REP
Intended Use
EMERGO EUROPE - Molenstraat 15 2513 BH, The Hague, The Netherlands
The UPS (Universal Power Supply) is intended for use only with Starion Cautery Instruments and PowerPack Footswitch for the simultaneous cutting and cauterization of soft tissue during surgery.
Starion Instruments Corporation 775 Palomar Avenue, Sunnyvale, CA 94085 USA 1 800-STARION +1 408-522-5200 www.starioninstruments.com
© Copyright 2006, Starion Instruments Corporation. All rights reserved.
Symbol Definition
0344
IFU0026C-01 ECO#1346
EC REP
Means:
Attention - Read and follow indicated Instructions For Use, Precautions, Warnings, etc.
Means:
On (power: connection to the mains).
Means:
Off (power: disconnection from the mains).
Means:
Type CF apllied part.
Means:
Authorized Representative
Means:
Footswitch Connector.
Means:
Instrument Connector.
Means:
Temperature.
Means:
Relative Humidity.
Means:
Atmospheric Pressure.
If using multiple Starion Cautery Instruments, do not allow instruments to contact each other.
Instructions For Use
Do not touch electrosurgical (Bovie) electrode to Starion Instruments.
1. Connect grounded, Hospital Grade power cord to the UPS AC connector.
Procedures using instruments for cutting/cauterization should be performed only by persons having adequate training and familiarity with these surgical techniques. Consult the medical literature relative to techniques, complications and hazards prior to performance of any procedure. Surgeons using this device should be familiar with the specific anatomy of the region in which they intend to perform the procedure.
2. Plug the power cord into a grounded Hospital Grade receptacle. 3. After aligning the keyed portion of the connector, insert the connector of the Starion Cautery Instrument into the Instrument connector of the UPS (Universal Power Supply).
If using the Ultra Slim device, see Instructions For Use for pre-check information.
4. If the PowerPack Footswitch is to be used, plug it into the Footswitch connector of the UPS (Universal Power Supply).
No user serviceable parts.
5. Turn on the UPS (Universal Power Supply).
Note: The UPS (Universal Power Supply) is not intended for continuous use. A typical duty cycle of approximately five (5) seconds on, ten (10) seconds off is recommended. If the UPS (Universal Power Supply) is used continuously, or the instrument connector becomes shorted, the output of the UPS (Universal Power Supply) may be interrupted. This will be indicated by an absence of audible tone. Attempt to determine the cause of the problem before proceeding. If problem cannot be resolved or power is not restored after several minutes of cool-down, contact Starion Instruments for instructions regarding repair or replacement of the device.
6. Refer to the appropriate Starion Cautery Instrument and PowerPack Footswitch, if applicable, Instructions For Use for device specific use instructions and pre-check requirements. 7. When the heating element is activated, the UPS (Universal Power Supply) emits a tone that will last until the heating element is deactivated. The amount of heat delivered to the device heater may be adjusted by varying the knob setting on the UPS (Universal Power Supply). Increasing the knob’s numerical value setting increases the amount of heat delivered to the device when using a single-range device or the variable range when using the optional PowerPack Footswitch accessory or multi-range device. Generally, lower heat ranges increase the sealing capabilities and increase the time required to divide tissue. Higher heat ranges decrease the time to divide and may decrease seal integrity.
Warning:
Do not use in the presence of flammable materials (e.g. alcohol, flammable anesthetics).
8. At the end of the surgical procedure, turn the UPS (Universal Power Supply) off and disconnect the Starion Cautery Instrument and if applicable, the PowerPack Footswitch.
Always disconnect the instrument before discarding; the UPS (Universal Power Supply) is reusable.
Handling, Storage & Cleaning
Precautions and Warnings
Do not drop. Store in a cool, dry place. Avoid prolonged exposure to extreme temperatures. Exterior of the UPS (Universal Power Supply) may be cleaned using a soft cloth moistened with a solution of water and mild detergent or disinfectant. Do not immerse the UPS (Universal Power Supply) in liquids.
Note: Only power cord for North America (U.S. and Canada) is supplied with UPS (Universal Power Supply). For other locales, ensure that the appropriate power cord and connector are used, per National Guidelines (i.e. HAR, 250 VAC, 2A, 3 x 0.75 mm2, minimum).
Recommended Environmental Conditions
When used in the U.S. use only with supplied Hospital Grade power cord connected to Hospital Grade receptacle. Use only with Starion Cautery Instruments and PowerPack Footswitch. Use of any other instrument may damage the instrument/Universal Power Supply and could prevent it from functioning properly during use. Do not drop the UPS (Universal Power Supply). Do not immerse the UPS (Universal Power Supply) in liquids. Do not sterilize UPS (Universal Power Supply).
Transport
Storage
Operating
-15°C to 50°C
15°C to 30°C
15°C to 30°C
25 to 95
30 to 85
45 to 75
700hPa to 1060hPa
700hPa to 1060hPa
700hPa to 1060hPa
There are no unusual risks associated with the proper disposal of this equipment. Follow any local regulations regarding proper disposal of used electronic equipment.
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UPS
UNIV POW ERSAL SUPP ER LY
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Power on LED indicator
Hanger
Footswitch Connector and Indicator
AC Connector
On/Off Switch
Cautery Instrument Connector and Indicator