Microline Surgical 200-006R Bedienungsanleitung

SURGICAL
Microline Surgical, lnc
50 Dunham Road, suite 1500
Beverly, MA 01915. USA
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
Microfine Cautery Instrummts and Microline Po•werPacktU Dual Control Footswitch
Device Description
The Moc±l # 200-006R Universal Power Supply (UPS) is a nan-sterile, reusable, AC powered unit intended to be used only with Microline Cautery Instruments and
connected to AC poær via a grounded hospital grade power cord and features an onloff 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 he 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 Suspendedfrom an IV pole. the ups may be rotated to face the user.
Intended Use
The LIPSis intended for use only with Microline Cautery Instrurnents and the PowerPack Dual Control Footswitch for the simultaneous cutting and cauterization Of soft tissue during surgery.
Operating Sequence
1. Connect 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 LIPSconnector receptacle and insert.
4. If the PoværPack Dual Control Footswitch is to be used, plug the Footswitch connector into the Footswitch connector receptacle of the IJPS.
5. Turn on the UPS.
6. Refer to the appropriate Microline Cautery Instrument and Po•.verPackDual Control Footswitch (if applicable) Instructions For Use for device specific use instructions and pre-check requirernents.
7. Model # 200-006R: When the instrument heating element is activated,
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 mufti-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 Instrunnentand 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 Ofthe UPS may be cleaned using a soft cloth moistened with a solution Ofwater and a mild detergent or disinfectant (such as Cidex
or Sporicidin). Do not immerse the UPS in liquids.
Recommended Environmental Condiions
Trans rt
-150C to 400
10t095
700hPa to 1060hPa
If transported or stored at temperatures wtside the operating temperature range, allow one hourfor the UPS to reach room temperature before use. There are no unusual risks associated with theproper disposal of
this equipment. Follow any local regulations regarding proper disposal of used electrical equipment.
Model 200-006R
Universal Power Supply
1- Hanger
2- Volurne LED Indicators
3- Volume Control Buttons
4- Footswitch Connector Receptacle and Indicator
5- AC Connector Receptacle
6- Power On LED Indaor
7- On,'Off Switch
8- Cautery Instrument Connector
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 UP'S. For other locales. ensure that the appropriate power cord and connector are used, per National Guidelines (i.e. HAR. 250 VAC, 2A, 3 x O. 7 5 mm2.
minimum).
Precautions
When used in the US. 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 instrumenVUPS and could prevent it from functioning property 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 SMOOOIfor additional information.
Use caution in hanging or placing the UPS on a surface prior to use. To isolate the UPS from supply mains
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
output of the I-JPSmay be interrupted. This Willbe 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 presence of flammable materials (e.g alcohol, flammable
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. cornplicaüons
and hazards prior to performance of any procedure. Surgeons using this device should be familiar with the specific anatomy of the region in
can result in serious. unintended patient injury. including bowel perforation.
• Avoid use in the proximity OfOther equipment that may interfere with the proper operation of
The 200-006R is not intended for use in direct
WARNING: No modification of this equipment is alowed
Electrical Requirements
Input 100-240 VAC. 5060 Hz. ISOVA
Maximum OutBJt: 60W
No Load Voltage: 9V D.C.
Compliance with Standards
The UPS complies with IEC60601-1 (CAN/CSA.C222 NO.601. I-M90) requirements for type Class l, Type BF equipment, Type BF applied parts, and meets electromagnetic compatibility requirements Of
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
Symbol Definitions
Not made with natural rubber latex
1
Means: Temperature.
Means: Relative Humidity,
Means: Instrument Connector.
Means: General Warning.
Medical Device Safety Service GmbH
EC REP
Schiffgraben 41
D-30175 Hannover
Germany
Manufactured under One or more of US patents; 7,033.351 ;
the UPS emits a tone that will last until the heating element is deactivated.
Stor e O
-150C to 350 150Ct0350
10 to 93
700hPa to 1060hPa 700hPa
Receptacle and indicator
five (5) seconds on. ten (10) seconds df is recommended.
anesthetics).
and unintended.
contact with the heart and is naw rated •BE.
Means: On (Power connected
to the mains).
Means: Atmospheric
Pressure.
Means: Type BF applied Part.
6,908.463,
ENGLISH
ratin
30 to 93
to 1060hPa
disconnect the power cord either from the bottom of the UPS or from the wall. Ensure access to these points are
irreversible tissue necrosis.
UPS
Surgical, Inc. be liable for consequential damages.
Means: Footswitch Connector
O
Means: Off (Power disconnected from
the main.
Means: Refer to instruction booklet.
09-39-00119-00
6,626,901. Patents Pending All Rights Reserved
Po•werPackDual Control Footswitch. The UPS is intended to be
The amount of heat delivered by the instrument heater may be adjusted by pressing
Ifthe UPS is used 'nitinuously. or the instrument
they intend to perform he procedure use of this
0086
Rev E
connector becomes shorted, the
without such trainhg