Microline Surgical 200-006R Instrucciones De Uso

Microline Surgical, Inc.
800 Cummings Center
Suite 166T
Beverly, MA 01915
TEL: (978) 922-9810 | FAX: (978) 922-9209
Web: www.microlinesurgical.com
Email: [email protected]
UPS Universal Power Supply – Model # 200-006R / 200-004R - Instructions For Use
For use only with
Microline Cautery Instruments and Microline PowerPack™ Footswitch
Device Description
The Model # 200-006R / 200-004R Universal Power Supply (UPS) is a non-sterile, reusable, AC powered unit intended to be used only with
Microline Cautery Instruments and the PowerPack Footswitch. The UPS 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 from the UPS with corresponding tones indicating the power level of the instruments heating element. A low freq uency tone
indicates the use of low heat. An interrupted low tone indicates the use of variable heat, and a higher frequency continuous tone indicates the
use of high heat levels. If the instrument does not require the use of the PowerPack Footswitch, the UPS will supply power at the variable heat
level only, unless a multi-heat range device is used. The UPS may be placed on a flat non-sterile surface adjacent to the sterile field, or may be
suspended from a nearby IV pole. If suspended from an IV pole, the UPS may be rotated to face the user.
Intended Use
The UPS is intended for use only with Microline Cautery Instruments and the PowerPack Footswitch for the simultaneous cutting and
cauterization of soft tissue during surgery.
1. Connect grounded, Hospital Grade power cord to the UPS AC connector receptacle.
2. Plug the power cord into a grounded Hospital Grade receptacle.
3. Align the key portion of the Microline Cautery Instrument connector with the UPS connector receptacle and insert.
4. If the PowerPack Footswitch is to be used, plug the Footswitch connector into the Footswitch connector receptacle of the UPS.
5. Turn on the UPS.
6. Refer to the appropriate Microline Cautery Instrument and PowerPack Footswitch (if applicable) Instructions For Use for device specific use
instructions and pre-check requirements.
7. Model # 200-006R: When the instrument heating element is activated, the UPS emits a tone that will last until the heating element is
deactivated. The amount of heat delivered by the instrument heater may be adjusted by pressing the "+" or "-" push pads on the right side of the
UPS. The numerical setting is shown on the LED bar graph above the push pads. Increasing the LED's numerical value setting increases the
amount of heat delivered by the instrument when using a single-heat range instrument or the variable range when using the optional PowerPack
Footswitch accessory or multi-heat range instrument. 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.
8. Model # 200-004R: When the instrument 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 by 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 by 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.
9. At the end of the surgical procedure, turn the UPS off and disconnect the Microline Cautery Instrument and if applicable, the PowerPack
Footswitch.
Handling, Storage And Cleaning
Do not drop. Store in a cool, dry place. Avoid prolonged exposure to extreme temperatures. Exterior of the UPS may be cleaned using a soft
cloth moistened with a solution of water and a mild detergent or disinfectant. Do not immerse the UPS in liquids.
Recommended Environmental Conditions
-15ºC to 50º
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 electrical equipment.
Model # 200-006R
Universal Power Supply
1- Hanger
2- Volume LED Indicators
3- Volume Control Buttons
4- Footswitch Connector Receptacle and Indicator
5- AC Connector Receptacle
6- Power On LED Indicator
7- On/Off Switch
8- Cautery Instrument Connector Receptacle and indicator
9- Power Level Control Buttons
10- Power Level LED Indicators
Model # 200-004R
Universal Power Supply
Non Sterile
1- Power On LED indicator
2- Hanger
3- Footswitch Connector and Indicator
4- AC Connector
5- On/Off Switch
6- Cautery Instrument Connector and Indicator
Note: A power cord for North America (U.S. and Canada only) is supplied with the UPS. 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).
Precautions And Warnings
• When used in the U.S. use only with supplied Hospital Grade power cord connected to Hospital Grade receptacle
• Use only with Microline Cautery Instruments and PowerPack Footswitch. Use of any other instrument may damage the instrument/UPS and
could prevent it from functioning properly during use
• Do not drop the UPS
• Do not immerse the UPS in liquids
• Do not sterilize the UPS
• If using multiple Microline Cautery Instruments, do not allow instruments to contact each other. Do not touch electrosurgical (Bovie) electrode
to Microline Cautery Instruments.
• 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.
• If using the UltraSlim or SC Forceps device, see Instructions For Use for pre-check information.
• There are no user serviceable parts.
Note: The UPS 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 is used continuously, or the instrument connector becomes shorted, the output of the UPS 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 Microline Surgical for instructions regarding repair or replacement of the
device.
Warning:
The 200-006R is not intended for use in direct contact with the heart and is now rated "BF".
Do not use in the presence of flammable materials (e.g. alcohol, flammable anesthetics).
Always disconnect the instrument before discarding; the UPS is reusable.
Electrical Requirements
Input: 100-240 VAC, 50/60 Hz, 100W
Maximum Output: 60W
No Load Voltage: 9V D.C.
Compliance with Standards
The UPS complies with IEC60601-1 (CAN/CSA-C22.2 No. 601.1-M90) requirements for type Class I, Type BF equipment, Type BF applied
parts, and meets electromagnetic compatibility requirements of IEC60601-1-2. Avoid use in the proximity of other equipment that may interfere
with the proper operation of the UPS.
Limited Warranty
Microline Surgical, Inc. warrants that the UPS 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. Microline 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 Microline Surgical, Inc. be liable for
consequential damages.
Symbol Definition
Transport
25 to 95
700hPa to 1060hPa
Storage
-15ºC to 30º
30 to 85
Operating
15ºC to 30º
45 to 75
700hPa to 1060hPa
ENGLISH