Important Safety Information

重要安全資訊
人工耳蝸植入系統

在最佳輔助條件下,借助聽覺放大卻收效甚微、或者根本無效的重度至極重度聽力受損患者,可使用 MED EL 人工耳蝸植入系統對其聽覺通路進行電刺激來激發聽覺。

人工耳蝸植入術是一種處方治療手段,如果您認為您是潛在的候選人,請聯繫您的醫生或聽力醫療中心,讓他們根據您本地專業標準為您進行術前評估。某些醫療狀況,包括聽覺神經損傷、內耳畸形、中耳感染、顱內畸形以及對植入體材料的過敏可能構成一些禁忌症。

為了獲得最佳的植入效果,應對即將接受人工耳蝸植入手術的使用者及其家屬予以鼓勵,且他們應對人工耳蝸所帶來的預期效果持有合理的期望,同時應瞭解返回植入中心定期程式化設定音訊處理器、接受階段評估及訓練的重要性。

與人工耳蝸植入術可能關聯的風險包括(但不限於):全身麻醉並發症、術後手術並發症(頭暈、眩暈增加、瘢痕癒合延遲、味覺受損、包括腦膜炎等的罕見感染、潛在性吞嚥困難、感覺麻木、耳鳴增加、顏面神經刺激、刺激時會產生暫時性疼痛與刺耳的聲音。),潛在性殘餘聽力喪失以及在植入物損傷的情況下需要額外手術等。植入手術之後,會對磁力共振成像產生一些局限性。
 

醫療程式
MED-EL 植入系統

本手冊爲 MED-EL 植入系統用戶在必須接受醫療程序(例如磁共振成像)時提供了重要指示 和安全資訊。

作為植入系統使用者,您對將要接受的進一步醫療程式可能會有一些疑問。您的醫療團隊也 可能需要詳細了解有關植入系統用戶的特殊注意事項。本指南提供的資訊將有助於防止您的 植入系統損壞並防止您自己受傷。請將這些資訊與您的醫務人員分享。

本文檔中部分産品目前並未在所有國家獲得批准或銷售。請聯繫您的本地 MED-EL 代表瞭解 您所在國家目前的產品銷售情況。

本文中通用的“MED-EL 植入系統”泛指所有類型的植入系統。具體的植入系統名稱詳見相應 章節的標題。

Download Manual (pdf)
中文

專業人員 MRI
核查表

"專業人員 MRI 核查表”包含與 MRI 檢查相關的產品標籤摘錄。這對計劃、接受 MRI 檢查會有所幫助,因為它按時間順序列出了應完成的任務。

Download Checklist (pdf)
中文


Important Safety Information
Cochlear Implant Systems

The MED-EL Cochlear Implant Systems are intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

Cochlear implantation is a prescription treatment, if you believe you are a potential candidate, contact your physician or hearing healthcare center for a pre-operative assessment according to the local professional standards. Certain medical conditions, including auditory nerve damage, inner ear malformations, middle ear infection, cranial malformation and allergies to the implant materials may constitute some contraindication(s).

To obtain the optimal benefit from the implant, the prospective implant users and their families shall be highly motivated and have realistic expectations about the expected benefit of the implant and shall understand the importance of returning to the implant center for regular audio processor programming, assessment sessions and training.

Risks associated with cochlear implantation include, but are not limited to: complications from general anesthesia, post-operative surgical complications (dizziness, increased vertigo, delay of healing of the scar, impairment of the sense of taste, infection including rare instances of meningitis, potential for swallowing difficulties, numbness, increased tinnitus, stimulation of the facial nerve, temporary pain and uncomfortable sounds during stimulation), potential loss of residual hearing, need for additional surgery in case of damage to the implant. After implantation, some limitations regarding magnetic resonance imaging will apply.
 

Medical Procedures
for MED-EL Implant Systems

This manual provides important instructions and safety information for MED-EL Implant System users who have to undergo a medical procedure (e.g. MRI).

As an implant user, you might have questions about undergoing further medical procedures. Your medical team may also want more information about any special considerations for implant users. This guidance provides information that will help prevent damage to your implant and injury to yourself. Please share this information with your healthcare provider.

Not all products in this document are currently approved or available in all countries. Please contact your local MED-EL representative for information on current product availability in your country.

In this document the general term “MED-EL Implant System” is used for all implant types. The specific implant name is identified in the header of the applicable section.

Download Manual (pdf)
English

MRI Checklist
for professionals

The “MRI Checklist for professionals” contains excerpts of product labeling relevant for MRI examinations. It may be helpful when planning and performing an MRI as it lists tasks to be completed in chronological order.

Download Checklist (pdf)
English

© 2017 MED-EL