Microline Surgical ReNew 3900 Serie Instrucciones De Uso página 3

ELECTROCAUTERY
First, connect the electrosurgical cord (not furnished with the instrument) to the handpiece by placing the female end of the cord
on the male adapter pin on the handpiece. Plug the other end of the cord into the monopolar receptacle of the generator.
ELECTRICAL RATINGS
To reduce the risk of electrical burn or shock, handpieces and tips are not to be used beyond their maximum recurring peak
voltage ratings (Vp):
RATING MODE
800 Vp Cut mode (Cut, Cut Pure)
1.25 KVp Coag Burst mode (Blend, Desiccate)
2.65 KVp Coag Spray mode (Fulgurate, Spray)
ELECTRICAL PRECAUTIONS
A complete understanding of the principle of monopolar electrocautery surgical procedures is necessary to avoid accidental
1.
shocks, burns, or potential gas embolism to the patient.
Be sure that a return electrode grounding pad has been properly attached to the patient and the generator.
2.
Do not activate the generator until the metallic end of the tip is in contact with the tissue or is in a position to deliver high
3.
frequency energy to the tissue.
Keep the power as low as possible to achieve the desired effect.
4.
Use only with safety certified HF generators (IEC 60601-1).
5.
Refer to the HF generator IFU for operating instructions and warnings.
6.
Refer to the HF generator IFU for selection of HF cable and neutral pad electrode consistent with handpiece ratings.
7.
CAUTION: To reduce risk of electrical burn or shock, do not rest fingers or hands near metal parts during use, particularly
8.
near cautery cap connector or between handles.
REUSE LIFE
Due to the product design, the raw materials used and the intended purpose, it is not possible to determine a precise limit with
regard to the maximum possible number of reprocessing cycles. The serviceable life of the instruments is determined by their
function as well as by careful handling.
The device has undergone reprocessing cycle validation to 90 uses. The functional inspection must be completed before each use.
In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing
conditions.
ENVIRONMENTAL PROTECTION
To reduce contamination risks, the ReNew Handpiece and tips shall be disposed of in compliance with all applicable local, state
and federal laws and regulations.
Cleaning, sterilization, and grinding to enable recycling may be considered environmentally friendly, and supportive of circularity.
Alternatively, Incineration may also be considered a safe disposal method.
WARRANTY
Product warranty is available by contacting Microline Customer service, or by visiting
https://www.microlinesurgical.com/resources/policies/.
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
SYMBOL DEFINITIONS
Following are the graphical symbols and their descriptions used in the labeling of the ReNew Handpieces:
Manufacturer
Catalog number
Lot Number
Do not use if package is damaged
Global Trade Item Number
Quantity
Non-sterile
Recyclable, contains recycled content.
Medline is a registered trademark owned by Medline Industries Inc.
Steris and Amsco are a registered trademarks owned by Steris Inc.
Enzol is a registered trademark owned by ASP Global Manufacturing, GmbH.
Contains: one Handpiece
FDA cleared. K962119
‫ﻣﺧﺻﺻﺔ ﻟﻼﺳﺗﺧدام ﻓﻲ ﻗطﻊ اﻷﻧﺳﺟﺔ وإﻣﺳﺎﻛﮭﺎ وﺗﺷرﯾﺣﮭﺎ وﺗﺟﻠﯾط اﻟدم ﺑﮭﺎ أﺛﻧﺎء ﻋﻣﻠﯾﺎت اﻟﺗﻧظﯾر اﻟداﺧﻠﻲ واﻟﻌﻣﻠﯾﺎت اﻟﺟراﺣﯾﺔ ﺑﺎﺳﺗﺧدام‬
.‫ﺳﻠﯾم ھذا اﻟﺟﮭﺎز ﺑدون طرف‬ ‫اﻓﺣص ﻋﻠﺑﺔ اﻟﺷﺣن اﻟﻛرﺗوﻧﯾﺔ وﻣﺣﺗوﯾﺎﺗﮭﺎ ﺑﻌﻧﺎﯾﺔ ﻟﻠﺗﺣﻘﻖ ﻣن ﻋدم وﺟود أي ﻋﻼﻣﺎت ﻟﻠﺗﻠف. ﻓﻲ ﺣﺎﻟﺔ اﻛﺗﺷﺎف ﺗﻠف ﺑﺎﻟﺟﮭﺎز، ﻻ ﺗﺳﺗﺧدﻣﮫ. ﯾﺗم ﺗ‬
‫اﻟﺣﻠﻘﺎت ﻟﺗرﻛﯾﺑﮭﺎ ﺣول ﻓﺗﺣﺗﻲ اﻹﺻﺑﻊ‬
‫ﻟداﺧﻠﻲ ﻟﺣﻠﻘﺎت اﻹﺻﺑﻊ ﺑﺎﻷداة اﻟﯾدوﯾﺔ. ﯾﻣﻛن اﺳﺗﺧدام ﻣﺟﻣوﻋﺎت ﺣﻠﻘﺎت‬
. ‫وﻣﻊ اﻹﺑﻘﺎء ﻋﻠﻰ اﻟﺷﻔرﺗﯾن/اﻟﻔﻛﯾن اﻟﺧﺎﺻﯾن ﺑﺎﻟطرف واﻟﻣﻘﺎﺑض اﻟﺧﺎﺻﺔ ﺑﺎﻷداة اﻟﯾدوﯾﺔ ﻓﻲ وﺿﻊ اﻹﻏﻼق اﻟﺧﺎص ﺑﮭم، أدﺧل اﻟطرف ﻓﻲ اﻟﻌﻣود‬
"STERILIZE BEFORE USE"
3900 ‫اﻟﺗﻧظﯾرﯾﺔ اﻟﯾدوﯾﺔ اﻟﻣزودة ﺑﺳﻘﺎطﺔ وﻏﯾر اﻟﻣزودة ﺑﺳﻘﺎطﺔ ﻣن اﻟﺳﻠﺳﻠﺔ‬
‫زﯾﺎرة‬ ‫طرﯾﻖ‬
.‫اﻟﺑطن اﻟﺟراﺣﻲ( ﻋﻠﻰ ھذا اﻟﺟﮭﺎز‬
‫ﺳم‬ 34 ‫اﻟﻣزودة ﺑﺳﻘﺎطﺔ، ﻣﻘﺎس‬
‫ﺳم‬ 42 ‫اﻟﻣزودة ﺑﺳﻘﺎطﺔ، ﻣﻘﺎس‬
‫ﺳم‬ 25 ‫اﻟﻣزودة ﺑﺳﻘﺎطﺔ، ﻣﻘﺎس‬
‫ﺳم‬ 34 ‫اﻟﻣزودة ﺑﻌﻣود ﺻﻠب، ﻣﻘﺎس‬
‫ﺳم‬ 42 ‫اﻟﻣزودة ﺑﻌﻣود ﺻﻠب، ﻣﻘﺎس‬
‫ﺳم‬ 34 ‫اﻟﻣزودة ﺑﻌﻣود ﺻﻠب وﺳﻘﺎطﺔ، ﻣﻘﺎس‬
‫ﺳم‬ 42 ‫اﻟﻣزودة ﺑﻌﻣود ﺻﻠب وﺳﻘﺎطﺔ، ﻣﻘﺎس‬
.‫اﻟﯾدوﯾﺔ وأﻧﮫ ﻣﺗطﺎﺑﻖ ﻣﻊ ﺗﻌﻠﯾﻣﺎت اﻻﺳﺗﺧدام اﻟﻣرﻓﻘﺔ‬
‫ﺗﺄﺗﻲ ھذه اﻷداة ﻣزودة ﺑﻣﺟﻣوﻋﺗﯾن ﻣﻧﻔﺻﻠﺗﯾن ﻣن ﻋﺑوات ﺣﻠﻘﺎت ﻏﯾر ﻣطﺎطﯾﺔ ﻗﺎﺑﻠﺔ ﻹﻋﺎدة اﻻﺳﺗﺧدام )أﺣﺟﺎم ﺻﻐﯾرة وﻣﺗوﺳطﺔ(. ﺗم ﺗﺻﻣﯾم ھذه‬
‫اﻟﻣوﺟودﺗﯾن ﺑﺎﻟﻣﻘﺑض ﻣن اﻟداﺧل، واﻟﮭدف ﻣﻧﮭﺎ ھو زﯾﺎدة راﺣﺔ اﻟﺟراح إﻟﻰ أﻗﺻﻰ درﺟﺔ ﻋن طرﯾﻖ ﺿﺑط اﻟﺣﺟم ا‬
.‫ﺻﻐﯾرة أو ﻣﺗوﺳطﺔ أو ﻋدم اﺳﺗﺧدام ﺣﻠﻘﺎت أﺛﻧﺎء اﻟﻌﻣﻠﯾﺔ، وذﻟك ﺑﻧﺎ ء ً ﻋﻠﻰ ﻣﺎ ﯾرى طﺑﯾب اﻟﺟراﺣﺔ أﻧﮫ أﻛﺛر راﺣﺔ‬
‫ﻣطﺎطﯾﺔ‬ ‫ﻏﯾر‬ ‫اﻟﺣﺟم‬ ‫ﻣﺗوﺳطﺔ‬
‫ﻗم ﺑﺈزاﻟﺔ اﻟﺷرﯾط اﻷﺑﯾض ﻣن ﺷﻔرات/ﻓﻛﻲ اﻷطراف. ﺗﺄﻛد ﻣن أن اﻟﺷﻔرات/اﻟﻔﻛﯾن ﻣﻐﻠﻘﺗﺎن ﺗﻣﺎﻣ ﺎ ً ﺑﺈﺻﺑﻊ اﻟﺳﺑﺎﺑﺔ‬
.( 2 ‫واﻹﺑﮭﺎم )اﻧظر اﻟﺷﻛل‬
4 . 1 - ‫ﯾﻧﺑﻐﻲ ﻧزع اﻟﺷرﯾط ﻣن اﻟﻔﻛﯾن ﺑﺎﻟﻧﺳﺑﺔ ﻟﻸطراف اﻟﻣﺧﺻﺻﺔ ﻟﻼﺳﺗﺧدام ﻣرة واﺣدة ﻗﺑل ﻣﺣﺎوﻟﺔ اﻟﻘﯾﺎم ﺑﺎﻟﺧطوات‬
GENERATOR CREST FACTOR (CF)
CF< or = 2
2<CF<or = 6
CF>6
Rx Only
Autoclavable
‫ﯾﺔ‬ ‫ﻌرﺑ‬ ‫اﻟ‬
‫ﻋن‬ ‫أو‬ ، Microline ‫ﻋﻣﻼء‬ ‫ﺑﺧدﻣﺔ‬
‫ﺗﻧطﺑﻖ ﺟﻣﯾﻊ ﻣواﻧﻊ اﻻﺳﺗﻌﻣﺎل اﻟﺧﺎﺻﺔ ﺑﺈﺟراءات اﻟﺗﻧظﯾر اﻟداﺧﻠﻲ اﻟﺟراﺣﯾﺔ )ﺑﻣﺎ ﻓﻲ ذﻟك ﺗﻧظﯾر‬
.‫ﺗﺧزﯾن وﻓﻘﺎ ﻹﺟراءات اﻟﺗﺧزﯾن اﻟﻘﯾﺎﺳﯾﺔ ﻓﻲ اﻟﻣﺳﺗﺷﻔﻰ‬
‫ﺳم‬ 34 ‫، ﻣﻘﺎس‬ ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
‫ﺳم‬ 42 ‫، ﻣﻘﺎس‬ ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
ReNew ‫، اﻷداة اﻟﯾدوﯾﺔ‬
3800 ، 3600 ، 3400 ، 3300 ،
‫ﺣﻠﻘﺎت‬ ‫ﻣطﺎطﯾﺔ‬ ‫ﻏﯾر‬
1 ‫اﻟﺷﻛل رﻗم‬
.‫أﻣﺳك ﺑﺎﻟﻔﻛﯾن وأدر ﻣﻔﺗﺎح ﺗدوﯾر اﻷداة اﻟﯾدوﯾﺔ ﺑﺎﺗﺟﺎه ﻋﻘﺎرب اﻟﺳﺎﻋﺔ ﺣﺗﻰ ﯾﺗم رﺑط اﻟطرف ﺑﺈﺣﻛﺎم‬
‫اﻟطرف ﻟ ﯾ ُﻔﺗﺢ ﺑﺎﻟﻛﺎﻣل. إذا ﻟم ﯾﻛن ذﻟك ﻣﻣﻛ ﻧ ً ﺎ، ﻓﺄﻋد اﻟﺧطوات‬
3 . 1 -
3
Consult instructions for use
Federal (USA) law restricts this device to
sale by or on the order of a physician
Date of Manufacture / Made in USA
Autoclavable
Medical Device
Not made with natural rubber latex.
ReNew
ReNew ‫اﻟﯾدوﯾﺔ وأطراف‬
‫اﻻﺗﺻﺎل‬ ‫طرﯾﻖ‬ ‫ﻋن‬ ‫ﻣﺟﺎ ﻧ ً ﺎ‬ ‫إﺿﺎﻓﯾﺔ‬ IFUs
https://www.microlinesurgical.com/resources/ifus/
‫اﻟ‬ .‫ظروف ﻣﺣددة ﻟﻠﺷﺣن أو اﻟﺗﺧزﯾن‬
‫أرﻗﺎم اﻟﻛﺗﺎﻟوج‬
3904
3905
3914
3915
3918
3924
3925
3934
3935
3100 ‫اﻟﺳﻠﺳﻠﺔ‬
3200 ‫اﻟﺳﻼﺳل‬ ReNew
.(‫أﻋﻼه‬ ‫ﺗﺗواﻓر اﻷطراف ﺑﺄﺷﻛﺎل ﻣﺗﻧوﻋﺔ )اﻧظر‬
ReNew ‫ﺗﺄﻛد ﻣن أن اﻟﺟﮭﺎز اﻟذي ﺗم اﺳﺗﻼﻣﮫ ھو أداة‬
‫اﻟﺣﺟم‬ ‫ﺻﻐﯾرة‬ ‫ﺣﻠﻘﺎت‬
‫ﺗﻌﻠﯾﻣﺎت اﺳﺗﺧدام ﻣﺟﻣوﻋﺔ أدوات‬
‫دواﻋﻲ اﻻﺳﺗﺧدام‬
ReNew ‫إن أدوات‬
.‫اﻟﻣﻧظﺎر‬
‫ﻋﻠﻰ‬ ‫اﻟﺣﺻول‬ ‫ﯾﻣﻛن‬ : ‫ﻣﻼﺣظﺔ‬
‫ﻣواﻧﻊ اﻻﺳﺗﺧدام‬
‫اﻟﺷﺣن واﻟﺗﺧزﯾن‬ ‫ﺷروط‬
‫ﺗوﺟد‬ ‫ﻻ‬
‫اﻟﯾدوﯾﺔ‬ RENEW ‫ﻣﻛوﻧﺎت أداة‬
‫اﻟﻣﻧﺗﺞ‬
ReNew ‫اﻷدوات اﻟﯾدوﯾﺔ‬
ReNew ‫ﻣﻘﺻﺎت أطراف‬
‫أطراف ﻣﺎﺳﻛﺎت وﻣﺷﺎرط‬
‫ﺗﻌﻠﯾﻣﺎت ﻟﻣﺎ ﻗﺑل اﻟﻔﺣص‬
1 .
2 .
‫اﻟﺗﺻﻣﯾم‬
‫ﻣﺟﻣوﻋﺔ اﻷداة اﻟﯾدوﯾﺔ/اﻟطرف‬
1 .
2 .
3 .
‫اﻓﺗﺢ‬ 4 .
5 .
.‫اﻷداة ﺟﺎھزة ﻟﻼﺳﺗﺧدام‬ 6 .