Microline Surgical 200-006R Instrucciones De Uso

Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915, U.S.A.
Tel: +1 (978) 922-9810 | Fax: +1 (978) 922-9209
Web: www.microlinesurgical.com
Email: info@microlinesurgical.com
UPS Universal Power Supply – Model # 200-006R Instructions For Use
For use only with
Microline Cautery Instruments and Microline PowerPack™ Dual Control Footswitch
Device Description
The Model # 200-006R Universal Power Supply (UPS) is a non-sterile, reusable, AC powered unit intended to be used only with Microline
Cautery Instruments and the PowerPack Dual Control 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 frequency 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 Dual Control 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 Dual Control Footswitch for the simultaneous cutting
and cauterization of soft tissue during surgery.
Operating Sequence
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 Dual Control 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 Dual Control 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
Dual Control 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. At the end of the surgical procedure, turn the UPS off and disconnect the Microline Cautery Instrument and if applicable, the PowerPack Dual
Control 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 (such as Cidex or Sporicidin). Do not immerse the UPS in liquids.
Recommended Environmental Conditions
-15ºC to 40º
700hPa to 1060hPa
If transported or stored at temperatures outside the operating temperature range, allow one hour for the UPS to reach room
temperature before use. 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
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
•
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 Dual Control 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.
•
There are no user serviceable parts. See UPS-006 Service Manual SM0001 for additional information.
•
Use caution in hanging or placing the UPS on a surface prior to use. To isolate the UPS from supply mains power, disconnect the power cord
either from the bottom of the UPS or from the wall. Ensure access to these points are kept clear.
•
Always disconnect the instrument before discarding; the UPS is reusable
•
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.
Warnings:
•
Do not use in the presence of flammable materials (e.g. alcohol, flammable anesthetics).
•
Remove all cables connected to the UPS away from the patient prior to use of a cardiac defibrillator.
•
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. Use of this equipment without such training can result in serious, unintended patient injury, including bowel perforation, and
unintended, irreversible tissue necrosis.
•
Avoid use in the proximity of other equipment that may interfere with the proper operation of the UPS
The 200-006R is not intended for use in direct contact with the heart and is now rated "BF".
•
WARNING: No modification of this equipment is allowed.
Electrical Requirements
Input: 100-240 VAC, 50/60 Hz, 150VA
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.
Limited Warranty
Microline Surgical, Inc. warrants that the UPS will be free from defects in materials and workmanship. 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 Definitions
Not made with natural rubber latex.
Means: Temperature
Means: Relative Humidity.
Means: Instrument Connector.
Means: General Warning.
Manufactured under one or more of US patents: 7,033,351; 6,908,463; 6,860,880; 6,695,837; 6,626,901. Patents Pending. All Rights
Reserved.
© Copyright 2011, Microline Surgical, Inc. All rights reserved.
Transport
10 to 95
700hPa to 1060hPa
.
Storage
-15ºC to 35º
10 to 93
Means: On (Power connected
to the mains).
Means: Atmospheric
Pressure.
Means: Type BF applied Part.
Operating
15ºC to 35º
30 to 93
700hPa to 1060hPa
Means: Footswitch Connector.
Means: Off (Power disconnected from
the main.
Means: Refer to instruction booklet.
ENGLISH
09-39-00119-00 Rev F