Important Safety Information

重要安全信息
人工耳蜗植入系统

在最佳辅助条件下,借助听觉放大却收效甚微、或者根本无效的重度至极重度听力受损患者,可使用 MED EL 人工耳蜗植入系统对其听觉通路进行电刺激来唤起听觉。

人工耳蜗植入术是一种处方治疗手段,如果您认为您是潜在的候选人,请联系您的医生或听力医疗中心,让他们根据您本地专业标准为您进行术前评估。某些医疗状况,包括听觉神经损伤、内耳畸形、中耳感染、颅内畸形以及对植入物材料的过敏可能构成一些禁忌症。

若要获得人工耳蜗的最大助益,准备接受植入的使用者及其家属应积极配合,对植入系统效果的期望应合乎实际,同时应认识到定期返回植入中心对声音处理器进行编程、进行评估会话并接受相关培训的重要性。

与人工耳蜗植入术可能关联的风险包括(但不限于):全身麻醉并发症、术后手术并发症(头晕、眩晕增加、瘢痕愈合延迟、味觉受损、包括脑膜炎等的罕见感染、潜在性吞咽困难、感觉麻木、耳鸣增加、面神经刺激、刺激期间暂时性疼痛和不适的声音),潜在性残余听力丧失以及在植入物损伤的情况下需要额外手术等。植入手术之后,会对磁共振成像产生一些局限性。
 

医疗程序
MED‑EL 植入系统

本手册为 MED-EL 植入系统用户在必须接受医疗程序(例如磁共振成像)时提供了重要指示 和安全信息。

作为植入系统用户,您对将要接受的进一步医疗程序可能会有一些疑问。您的医疗团队也可 能需要详细了解有关植入系统用户的特殊注意事项。本指南提供的信息将有助于防止您的植 入系统损坏并防止您自己受伤。请将这些信息转告您的医务人员。

本文档中部分产品目前并未在所有国家获得批准或销售。请联系您当地的 MED-EL 代表处, 以了解当前产品在您所在国家的可用性情况。

本文中通用的“MED-EL 植入系统”泛指所有类型的植入系统。具体的植入系统名称详见相应 章节的标题。

Download Manual (pdf)
中文-中国

专业人员 MRI
核查表

MRI 检查会有所帮助,因为它按时间顺序列出了应完成的任务。

Download Checklist (pdf)
中文-中国


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

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