Compliance With Standards; Symbol Definitions - Microline Surgical ENTceps Manual De Instrucciones

• Procedures using instruments for sealing/cutting 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.
• There are no unusual risks associated with the proper disposal of this equipment. it shall be disposed of in compliance with all
applicable local, state and federal laws and regulations
• There are no user-serviceable parts.
• If an adverse event occurs using this device please report it to Microline Surgical Customer Service as well as the Competent
Authority in your Member State (EU).
• Does not contain latex.
Warning:
• Do not use in the presence of flammable materials (e.g. alcohol, flammable anesthetics).
• Always disconnect the instrument before discarding; the PowerPack Dual Control Footswitch and UPS are reusable.
CONTRAINDICATIONS
The ENTceps / MicroCeps / CardioForceps are not to be used as a fallopian tube sterilization device.

COMPLIANCE WITH STANDARDS

When used with the UPS, the device complies with IEC60601-1 requirements for type BF applied part and meets electromagnetic
compatibility requirements of IEC60601-1-2.
HANDLING, STORAGE AND CLEANING
Do not drop. Store in a cool, dry place. Avoid prolonged exposure to extreme temperatures.
Do not immerse the device in liquids.
LIMITED WARRANTY
Microline Surgical warrants that its instruments are free from any defects in both material and workmanship. Microline Surgical shall
not be held liable for any incidental or consequential damage of any kind.
Work performed on an instrument will void this warranty.
Gross abuse or neglect of a Microline Surgical instrument will void this warranty.

SYMBOL DEFINITIONS

Manufacturer
Catalog Number
Batch code
Temperature Limit
Do not use if package is
damaged
Global Trade Item Number
Date of Manufacture
Variable Power
Humidity Limitation
Medical Device Safety Service GmbH
Schiffgraben 41
D-30175 Hannover
Germany
FDA cleared K000250
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.
Recyclable and printed on paper containing post-consumer recycled fiber.
Australian Sponsor:
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
‫ووﺣدة‬ ( 309 - 004 R :‫)اﻟﻣرﺟﻊ‬
‫أو‬
- 006 R 200 - 004 R
‫وﺗﺣﺗوي ﻋﻠﻰ‬ (UPS) ‫د طﺎﻗﺔ ﻣﺳﺗداﻣﺔ‬
PowerPack Dual Control
‫ﺳﺗﺧدام ھذه‬ ‫إ‬ ‫ﯾﻣﻛن أﯾ ﺿ ً ﺎ‬ . ‫اﻷﻧﺳﺟﺔ اﻟرﺧوة أﺛﻧﺎء اﻟﺟراﺣﺔ وﻓﻲ آن واﺣد‬
( . UPS ) ‫ووﺣدة اﻟﺗﻐذﯾﺔ اﻟﻣﺳﺗداﻣﺔ‬
‫وﻓ ﻘ ً ﺎ‬
( UPS ) ‫اﻟﺗﻐذﯾﺔ اﻟﻣﺳﺗداﻣﺔ‬
‫ر طرف ﻣوﺻل ﺳﻠك اﻟطﺎﻗﺔ ﺑﻌﯾ د ًا ﻋن‬
‫اﻟﺟﮭﺎز‬ . ‫وﺣدة اﻟﺗوﺻﯾل‬ ‫د ﻣن ﺗوﺻﯾل اﻟﻣﻘﺎﺑس ﺑﺷﻛل ﺻﺣﯾﺢ ﻓﻲ‬
‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم‬
ّ ‫ﻓﻲ ﻛﻣﯾﺔ ﺻﻐﯾرة ﻣن اﻟﻣﯾﺎه اﻟﻣﺎﻟﺣﺔ اﻟﻣﻌ ﻘ‬
‫أﻏﻠﻖ اﻟﺟﮭﺎز‬ . ‫ﻣﺔ‬
‫اﻟﺗﺳﺧﯾن‬ ‫ﺑواﺳطﺔ ﻋﻧﺻر‬ ‫ﮭﺎ‬ ‫اﻟﻣﯾﺎه اﻟﻣﺎﻟﺣﺔ ﯾﺗم ﺗﺳﺧﯾﻧ‬
‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم‬
‫ﻛرر اﻟﻔﺣص‬ . ‫إﺷﺎرة ﺻوﺗﯾﺔ ﻣﻧﺧﻔﺿﺔ‬
‫اﻟﺗﺳﺧﯾن اﻟﻣﺛﺑت‬ ‫ﻣﺎﻟﺣﺔ ﺑواﺳطﺔ ﻋﻧﺻر‬
( PowerPack Footswitch
( Microline PowerPack ™ Dual Footswitch
:‫)اﻟﻣرﺟﻊ‬ ( Microline UPS ) ‫وﺣدة اﻟطﺎﻗﺔ‬
ّ ‫ﺟراﺣﯾﺔ ﺗﻣﺳك ﺑﺎﻟﯾد وﯾﺗم ﺗﺷﻐﯾﻠﮭﺎ ﺑواﺳطﺔ اﻟﻘدم ﻋن طرﯾﻖ ﻣزو‬
) ‫ﻟﻠﺗﺷﻐﯾل اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم‬
( . UPS ) ‫ﯾﻣﺗد ﻛﺎﺑل اﻟطﺎﻗﺔ ﻣن ﻣﻘﺑض اﻟﺟﮭﺎز وﯾﻧﺗﮭﻲ ﻋﻧد ﻣوﺻل اﻟطﺎﻗﺔ ﻋﻠﻰ ﺟﮭﺎز اﻟﺗزوﯾد ﺑﺎﻟطﺎﻗﺔ اﻟﻣﺳﺗداﻣﺔ‬
( PowerPack Dual Control Footswitch
‫ﺑوﺣدة‬ ( Footswitch ) ‫اﻟـ‬ ‫ھذه اﻟوﺣدة‬
ّ ‫ﻣر‬ ، ‫ﻗم ﺑﻔك ﺳﻠك اﻟطﺎﻗﺔ‬ ‫. ل ﯾ‬ ‫وﺻ‬
‫ﺗﺄﻛ‬ .( UPS
‫و‬ ( UPS ) ‫وﺣدة اﻟﺗﻐذﯾﺔ اﻟﻣﺳﺗداﻣﺔ‬
(‫)اﻟﻣﻠﻘط‬ ‫اﻟﺟﮭﺎز‬
‫أن‬ ‫ﺣﯾث‬ ‫ھﺳﮭﺳﺔ‬ ‫ﺻوت‬
‫ﻟ‬ ‫اﻟﻧظﺎم اﻟﻣﺗﻐ ﯾ ّر‬ ‫ﻛرر ذﻟك ﺑﺎﺳﺗﺧدام‬
‫اﻟﺟﮭﺎز‬ ‫ﺻدر‬ ُ ‫ﺳ ﯾ‬ 8 . ‫ﻠﻰ اﻟﻣوﺿﻊ رﻗم‬
‫ﯾﺗم ﺗﺳﺧﯾن اﻟﻣﯾﺎه اﻟ‬ ‫ﻋﻧدﻣﺎ‬ ‫إذا ﻛﺎن ھﻧﺎك ﺻوت ھﺳﮭﺳﺔ‬
) ‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل ﺑواﺳطﺔ اﻟﻘدم‬
Consult instructions for use
Authorized representative in the European Community
Conformity European. This symbol means that the device
conforms with European directives and regulations for
product health, safety, and environmental protection.
Rx Only
Prescription Only
Sterilized by Gamma Radiation
Made in USA of US and imported parts.
Atmospheric Pressure Limitation
Use By Date
Do not re-use
‫اﻟﻌرﺑﯾﺔ‬
. ‫ﺗﻌﻠﯾﻣﺎت اﻹﺳﺗﺧدام‬ -
) ‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم ﻣن ﺻﻧﻊ ﺷرﻛﺔ ﻣﺎﯾﻛروﻻﯾن‬
‫أو‬ ( 200 - 003 R :‫)اﻟﻣرﺟﻊ‬
‫وات‬ ‫ھﻲ أد‬
ّ ‫ﯾﺗم ﺗﺷﻐﯾل ﻋﻧﺻر اﻟﺗﺳﺧﯾن ﻋن طرﯾﻖ وﺣدة اﻟﺗﺣ ﻛ‬
‫م ﺑﺎﻟطﺎﻗﺔ‬
ّ ‫ﻟﻘطﻊ وﻛ ﻲ‬ ‫ﺻﺔ‬ ّ ‫ھذه اﻷﺟﮭزة ﻣﺧ ﺻ‬ .
. ‫اﻷﺟﮭزة ﻟﻘطﻊ ﺧﯾوط اﻟﺗﻘطﯾب اﻟطﺑﯾﻌﯾﺔ أو اﻻﺻطﻧﺎﻋﯾﺔ ﻏﯾر اﻟﻣﻌدﻧﯾﺔ أﺛﻧﺎء اﻟﺟراﺣﺔ‬
) ‫اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم‬
‫ﻏﯾر ﻣﻌ ﻘ ّ م‬
‫ل ﯾ‬ ‫وﺻ‬ ‫اﻟﻣﻛﺎن اﻟﻣﺧ ﺻ ّ ص ﻟﺗ‬ ‫ﻓﻲ‬ (
‫اﻟﺗ‬ ‫ﺣدة‬ ‫د ﻣن ﺗوﺻﯾل ﻗﺎﺑس اﻟﻣوﺻل ﺑﺷﻛل ﺻﺣﯾﺢ ﻓﻲ و‬
) ‫ﺑوﺣدة اﻟﺗﻐذﯾﺔ ﺑﺎﻟطﺎﻗﺔ اﻟﻣﺳﺗداﻣﺔ‬
‫ﻗم ﺑﺈﻋداد‬ . ‫ﻟﻺﻋداد واﻟﺗﺷﻐﯾل اﻟﺻﺣﯾﺣﯾن‬
‫طرﻓﻲ‬ ‫ﺿﻊ‬ . ‫ﺳﺗﺧدام‬ ‫ﺑﺎﺗﺑﺎع اﻹرﺷﺎدات اﻟﻣﻌﻣول ﺑﮭﺎ ﻟﻺ‬
‫. ﺗر ﻗ ّ ب‬
‫ﺳﻣﺎع‬ ‫ﻋﻠﻰ اﻟﻔور‬ ‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم‬
. ‫إﺷﺎرة ﺻوﺗﯾﺔ ﻋﺎﻟﯾﺔ‬
ّ ‫ﻣﻘﺑض اﻟﺗﺣ ﻛ‬
‫ﻋ‬ ( UPS ) ‫وﺣدة اﻟﺗﻐذﯾﺔ‬ ‫م ﻓﻲ‬
. ‫ﻣﻠﻘط دون اﻟﺿﻐط ﻋﻠﻰ دواﺳﺔ اﻟﻘدم‬
. ‫ﺳﺗﺑدال‬ ‫ﻟﻺﺻﻼح أو اﻹ‬ Microline
‫ﺻوﺗﯾﺔ إﻻ إذا ﻛﺎن اﻟﺟﮭﺎز ﻣﻐﻠ ﻘ ً ﺎ ﺑﺎﻟﻛﺎﻣل و‬
‫ﺗوﺻﯾل‬ ّ ‫ﺗ م‬ ‫ﻗد‬
2
( CardioForceps / MicroCeps / ENTceps
( Microline PowerPack ™ UPS
( CardioForceps / MicroCeps / ENTceps
.‫ﻋﻧﺻر ﻟﻠﺗﺳﺧﯾن ﻣﺛﺑت ﻓﻲ اﻟطرف اﻟﺑﻌﯾد ﻟﻸداة‬
‫ﺗﺳﺗﺧدم ھذه اﻷﺟﮭزة ﻟﻣرة واﺣدة ﻓﻘط وھﻲ ﻣﺧ ﺻ ّ ﺻﺔ ﻟﻺاﺳﺗﺧدام ﻟﻣرﯾض واﺣد‬
‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل‬ ‫ﺑﻊ اﻹرﺷﺎدات اﻟﻣﻧﺎﺳﺑﺔ ﻻﺳﺗﺧدام‬
) ‫وﺣدة اﻟطﺎﻗﺔ ﻟﻠﺗﺷﻐﯾل اﻟﻣزدوج ﺑواﺳطﺔ اﻟﻘدم‬
ّ ‫ﺗﺄ ﻛ‬
( . Footswitch
‫ل اﻟﺟﮭﺎز‬ ‫ﯾ‬ ‫وﺻ‬ ‫ﺗ‬ ‫أدﺧل ﻣوﺻل ﺳﻠك اﻟطﺎﻗﺔ ﺑﺈﺣﻛﺎم ﻓﻲ ﻣﻘﺑس‬
( Microline
( PowerPack Dual Control Footswitch
‫ﻋﻠﻰ طﺎﻗﺔ ﻋﺎﻟﯾﺔ ﺑﺎﺳﺗﺧدام‬
ُ ‫ﺳوف ﺗ‬
‫ﺻدر‬ ( UPS ) ‫ﻛﻣﺎ أن وﺣدة اﻟﺗﻐذﯾﺔ‬
‫ﻣﻊ ﺗﺛﺑﯾت‬ ( PowerPack Dual Control Footswitch
‫اﻟ‬ ‫اﻟﻣﺳﺑﻖ ﺑﻣﺣﺎوﻟﺔ ﺗﻧﺷﯾط اﻟﺟﮭﺎز ﻋن طرﯾﻖ إﻏﻼق‬
‫اﺗﺻل ﺑﻣﻣﺛل‬ . Microline
‫اﻟ‬ ‫ﻹﺷﺎرة‬ ‫ا‬ ‫ﻟن ﯾﻌﻣل ﻋﻧﺻر اﻟﺗﺳﺧﯾن و‬
. ‫دواﺳﺔ‬ ‫ﺗ م ّ اﻟﺿﻐط ﻋﻠﻰ اﻟ‬ ‫، ﻛﻣﺎ‬
‫) ﺔ‬ ّ ‫اﻟﻣﻼﻗط اﻟﺟراﺣ ﯾ‬
‫ﺳﺗﺧدام ﻓﻘط ﻣﻊ‬
) ‫ﻣن ﻣﺎﯾﻛروﻻﯾن‬ ‫اﻟﺗﻐذﯾﺔ اﻟﻣﺳﺗداﻣﺔ‬
( . 200
‫وﺻف اﻟﺟﮭﺎز‬
‫) ﺔ‬ ّ ‫اﻟﻣﻼﻗط اﻟﺟراﺣ ﯾ‬
. ‫اﻟﻘﺎﺑﻠﺔ ﻹﻋﺎدة اﻻﺳﺗﺧدام‬ ( Footswitch
‫ﺳﺗﺧدام اﻟﻣﻘﺻود‬
ّ ‫أﺧرج اﻟﺟﮭﺎز ﻣن ﻋﺑوﺗﮫ اﻟﻣﻌ ﻘ‬
‫. ﻣﺔ‬
ّ ‫ﺗ‬
: ‫إ‬ ‫ﻣﻼﺣظﺔ‬
‫أدﺧل اﻟﻣوﺻل ﻣن‬
) ‫اﻟﺧﺎﺻﺔ ﺑﺎﺳﺗﺧدام اﻟـ‬ ‫ﻠﺗﻌﻠﯾﻣﺎت‬ ‫ﻟ‬
. ‫اﻟﺣﻘل اﻟﻣﻌﻘم‬
. ‫ﺟﺎھز اﻵن ﻟﻼﺳﺗﺧدام‬
‫ﻖ ﻣﺳﺑ ﻘ ً ﺎ ﻣن ﻧظﺎم‬ ّ ‫ﺗﺣ ﻘ‬
) ‫ﻣﺎﯾﻛروﻻﯾن‬
)
‫ﮫ‬ ‫وﻗم ﺑﺗﻧﺷﯾط‬
، ‫اﻟﻣﺛﺑت ﻋﻠﻰ طرف اﻟﺟﮭﺎز‬
)
‫، ﻻ ﺗﺳﺗﺧدم ﻧظﺎم‬ ‫ﻋﻠﻰ طرف اﻟﺟﮭﺎز‬
: ‫ﻣﻼﺣظﺔ‬
( UPS ) ‫اﻟﺗﻐذﯾﺔ اﻟﻣﺳﺗداﻣﺔ‬ ‫ﺑﺟﮭﺎز‬
‫ﻟﻺ‬
‫اﻹ‬
1 .
2 .
3 .