Simple 41301 User manual

www.simplemedical.cn
深圳简单医疗科技有限公司
肘关节固定带
说明书
产品型号：41301 产品规格：F
感谢您购买本公司产品！请在操作前仔细阅读此使用说
明书！以充分了解本产品，以保证本产品的安全性及有
效性，并请妥当保存说明书以备将来查阅。
一．产品概述
1.1 产品名称：肘关节固定带
1.2 产品型号：41301
1.3 产品规格：F
1.4 产品结构：
产品主要由软体大身，绑带，绑带扣以及魔术贴组成。
1.5 工作原理
产品采用轻量化的设计，使用方便，佩戴舒适。为
高强度运动时的肘部提供保护。
1.6适用范围
适用于减轻和预防与肌腱炎、网球肘、重复应力损伤
(RSI)和在工作场所或娱乐环境中的累积性创伤障碍
(CTDS)有关的疼痛。
二．产品特点及性能描述
2.1 产品特点及贮存条件
【产品特点】产品大小可调，左右通用，穿戴舒适。
【贮存条件】本产品应贮存在相对湿度不大于 80%、
无腐蚀性气体和通风良好的室内，避免高温
2.2 使用操作
【使用方法】
使用说明
步骤 1：打开产品（如图 1a）。
步骤 2：将护具穿进手里面去（如图 2b）。
步骤 3：将护具移动到小臂肌肉处，并把压缩海绵放置
在手小臂处，再绑紧绑带 1如图 3c）。
步骤 4：调整绑带的松紧度及压缩海绵的位置（如图 2b）
警告：绑带不要过紧，否则会有影响血液循环的风险，
请慎重调整绑带的松紧度。
保养与维护
产品可以用中性洗涤剂和 30℃水手洗，并自然风干。切勿
放入干衣机或使用其他热源进行干燥。盐水、沙子、污垢
等元素会造成伤害。暴露于这些条件后，用清水彻底冲洗，
毛巾擦干或风干（不要机器干燥）。如需洗涤剂请使用温
和洗涤剂，切勿使用柔软剂和漂白剂。
警告：
如果您在使用此产品时感到疼痛，肿胀，过敏，或有不适
的反应，请停止使用并咨询医生。
*此产品仅为保护装置，不用于防止再次发生伤害。
2.3 产品基本环境
1)环境温度：-15～60℃
2)相对湿度：≤80%
2.4 产品材料
1)大身：海绵/尼龙
2)绑带：海绵/尼龙
3)扣：塑胶
2.5 禁忌症
出现过敏者请勿用；
皮肤出现不明肿块者禁用；
皮肤肿破溃疡者禁用；
三．产品的保管，运输及有效期
3.1 产品有效期：3年。
3.2 产品的保管：未使用前请放置在干燥、清洁的室内，
保证室内通风。
3.3 运输：本产品在储存及运输的过程，应防尘、防潮、
防污染。
四．废弃物处理
包装纸（包装袋）的处理：本产品的包装请跟据所属地区
法例进行弃置处理，对垃圾进行分类。
五．标记符号及图片说明
注意，警告
禁止机洗
避免日晒
包装破损时切勿使用
有效期 3年
参考使用说明
六．配件清单
说明书------ 1 份
七．售后承诺
产品出现材料或工艺方面的缺陷，请直接联系你的
销售商，简单医疗科技有限公司将对产品进行维修
或更换。
八．厂家信息
【产品名称】肘关节固定带
【医疗器械备案凭证编号】
粤深械备 20201120 号
【生产备案凭证编号】
粤深食药监械生产备 20170002 号
【产品技术要求编号】
粤深械备 20201120 号
【备案人】深圳简单医疗科技有限公司
【生产企业】深圳简单医疗科技有限公司
【地址】深圳市龙华区民治街道新牛社区布龙路
1010 号智慧谷创新园 519
【电话】0755-86038563
【传真】0755-86038509
【邮政编码】518109
【售后服务单位】深圳简单医疗科技有限公司
【说明书修订日期】2020 年11 月23 号
【网址】www.simplemedical.cn

www.simplemedical.cn
Simple Medical（Shenzhen）Limited
Instructions for Use
Tennis Elbow Brace E2
Model: 41301 Size: F
Thank you for purchasing our products! Please read this
instruction carefully before operation! To fully understand the
product, in order to ensure the safety and effectiveness of the
product, and please properly save the manual for future reference
Product overview
1)Product name：Tennis Elbow Brace E2
2)Product model：41301
3)Product specification：F
4)Product Structure：
The product mainly consists of a soft body, a strap, a strap
buckle and a magic tape.
5)Operating principle:
The product is designed with light weight and is convenient to use
and comfortable to wear. And provides protection for the elbow at
the time of high-strength motion.
6)Scope of application:
It is suitable for relieving and preventing pain associated with
tendonitis, tennis elbow, repeated stress injury (RSI), and
cumulative trauma disorder (CTDS) in a workplace or an
entertainment environment.
Product features and performance description
1) Product features and storage conditions
【Product features】The product is adjustable in size, common in
the left and right, and comfortable to wear.
【Storage conditions】This product should be stored in a room
with no more than 80% relative humidity, no corrosive gas and
good ventilation to avoid high temperature
2)Using the operating
【Application Instructions】
APPLICATION INSTRUCTIONS
STEP 1: Open the product (Fig1a).
STEP 2: Put the tennis elbow brace in the hand (Fig 2b).
STEP 3: Move the guard to the small arm's muscle and place the
compression sponge at the hand arm and tie the strap 1 (Fig3c).
STEP 4: Adjust the tightness of the strap and the position of the
compressed sponge (Fig 4d)
WARNING: The strap should not be too tight, otherwise there
will be a risk of affecting the blood circulation. Please carefully
adjust the tightness of the strap.
Maintenance:
Product can use neutral detergent and 30 ℃water washed by hand,
and natural dry. Do not use clothes dryer or other heat source for
drying. Salt water, sand, dirt and other elements can cause damage.
After exposure to these conditions, rinse thoroughly with water, dry
with a towel or air dry (do not machine dry).If you need detergent,
please use mild detergent, do not use softener and bleach.
Warning:
If you experience pain, swelling, irritation, or discomfort while using
this product, discontinue use and consult your doctor.
*This product is for support only and is not intended to prevent injury
or to prevent the recurrence of injuries.
* For a single patient only, not recommended for multiple patients.
Basic product environment
1) Ambient temperature: -15 ~ 60 ℃
2) Relative humidity: 80%
Product material
1) Main body: sponge/nylon.
2) Straps: sponge/nylon.
3) Buckle: plastic.
Contraindication
Do not use in case of allergy;
Those with unknown skin masses are forbidden;
Those with swollen or ulcerated skin are forbidden;
Storage, transportation and expiry date of products
1 )Product is valid：Three years
2 )Product storage：Please place it in a dry and clean room before
use to ensure ventilation
3) Transportation: the product shall be dustproof, moisture-proof
and pollution-proof during storage and transportation
Disposal of wastes
Disposal of wrapping paper (bags): please dispose of the packaging of
this product according to the local laws.
Symbol and picture description
Manufacture Date
Batch Code
medical device
CE Symbol
Protect from sunlight
Hand wash only
Do not use when the packing is damaged
Warnings and Precautions
Reference instructions
Accessories list
Instructions------ 1 copy
After-sales warranty
If there is any defect in the material or process of the
product, please contact your vendor directly, and the Simple
medical will repair or replace the product.
Simple Medical (Shenzhen) Limited
Address: 519 Wisdom Valley, No.1010 Bulong Road,
Minzhi Street,Longhua District,
Shenzhen, China.518109
Tel : [phone]
Web: www.simplemedical.cn
E-mail: [e-mail]`
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
*Please refer to the Instructions before usage.